B40/B20 Patient Monitor
Technical Reference Manual
Patient Monitor B40/B20
English
2081505-001 G (Paper)
© 2021 General Electric Company.
All Rights Reserved.
B40/B20 Patient Monitor
Technical Reference Manual
0459
Conformity according to the Council Directive 93/42/EEC concerning Medical Devices amended by 2007/47/EC.
All specifications subject to change without notice.
Order code 2081505-001
Revision G
24 March, 2021
GE Medical Systems Information Technologies, Inc.
8200 West Tower Avenue
Milwaukee, WI USA
Zip: 53223
Tel: 1 414 355 5000 (outside US)
800 558 5102 (US only)
Fax: 1 414 355 3790
www.gehealthcare.com
Copyright © 2021 General Electric Company. All rights reserved.
GE Healthcare
3F Building 1, GE Technology Park
1 Huatuo Road
Shanghai PRC 201203
Tel: +86 21 3877 7888
Fax: +86 21 3877 7451
Classifications
In accordance with IEC 60601-1
−
Class I and internally powered equipment - the type of protection against electric shock.
−
Type BF or CF equipment. The degree of protection against electric shock is indicated by a
symbol on each parameter module.
−
Equipment is not suitable for use in the presence of a flammable anesthetic mixture with
air or with oxygen or nitrous oxide.
−
Continuous operation according to the mode of operation.
−
Portable Monitor
In accordance with IEC 60529
−
IP21 - degree of protection against harmful ingress of water.
In accordance with EU Medical Device Directive
−
IIb.
In accordance with CISPR 11:
−
Group 1 Class A;
•
Group 1 contains all ISM (Industrial, scientific and medical) equipment in which there
is intentionally generated and/or used conductively coupled radio-frequency energy
which is necessary for the internal functioning of the equipment itself.
•
Class A equipment is equipment suitable for use in all establishments other than
domestic and those directly connected to a low-voltage power supply network
which supplies buildings used for domestic purposes.
Trademarks
Listed below are GE Medical Systems Information Technologies and GE Healthcare Finland Oy
trademarks used in this document. All other product and company names contained herein
are the property of their respective owners.
Datex, Ohmeda, DINAMAP, Trim Knob, Unity Network, CARESCAPE, EK-Pro, TruSignal, Entropy,
GE Healthcare, GE Medical system, General Electric Company.
1
Introduction
About this manual
1
1
4
Overview
1.1
1.2
1.3
1.4
2
System description
2.1
2.2
2.3
2.4
2.5
2.6
3
3.2
3.3
4.3
4.4
16
Main components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3.1.1 Keypad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3.1.2 Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3.1.3 CPU board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
3.1.4 Power board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
3.1.5 AC/DC unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.1.6 Batteries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Interfacing computer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Connectors and signals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
3.3.1 External connectors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Hemo-dynamic module introduction
4.1
4.2
13
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Bus structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Distributed processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Module communication. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.4.1 Serial communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Parameter modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Software loading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Frame functional description
3.1
4
Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.2.1 General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.2.2 Safety message signal words . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.2.3 Safety precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.2.4 ESD precautionary procedures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.2.5 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Service information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.3.1 Service requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.3.2 Equipment identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Product security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
1.4.1 Security features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
1.4.2 Security operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
1.4.3 Product change management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
1.4.4 Communication. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
25
Monitor software compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Main components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
4.2.1 Hemo-dynamic module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
4.2.2 Signals and isolation barrier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
4.2.3 Power supply section. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
4.2.4 NIBP board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
4.2.5 ECG board in 5-lead measurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
4.2.6 STP board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Connectors and signals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
4.3.1 Front panel connectors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Measurement principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
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4.4.1
4.4.2
4.4.3
4.4.4
4.4.5
4.4.6
2
Hardware installation
1
Installation
1.1
1.2
1.3
1.4
1.5
1.6
1.7
1.8
1.9
1.10
3
NIBP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Pulse oximetry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Temperature. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Invasive blood pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Respiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
1
Unpacking instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Choosing location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Mounting the monitor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Connection to power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Check configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Connection to Network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.6.1 Pre-installation requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.6.2 To connect the network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.6.3 Network configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Inserting and removing the E modules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Monitor connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Visual indicators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Installation checkout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Maintenance
1
Instructions
1.1
1.2
2
Electrical Safety Tests
2.1
2.2
2.3
2.4
2.5
2.6
2.7
2.8
3
3
Test setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Power Outlet Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Power cord and plug. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Ground (earth) integrity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.4.1 Ground Continuity Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.4.2 Impedance of Protective Earth Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Earth leakage current test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Enclosure (Touch) leakage current test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Patient leakage current tests - overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2.7.1 Patient (source) leakage current test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.7.2 Patient (sink) leakage current tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Test completion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Installation checkout
3.1
3.2
1
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Recommended tools. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
13
Visual inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Functional inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
3.2.1 Start-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
3.2.2 Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3.2.3 Time and date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
ii
Document no. 2081505-001
3.2.4
3.2.5
3.2.6
3.2.7
4
Maintenance and checkout
4.1
4.2
4.3
5
16
Visual inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Functional inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
4.2.1 Start-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
4.2.2 Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
4.2.3 Keyboard(s) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
4.2.4 Time and date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
4.2.5 Hemo Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
4.2.6 Loudspeaker. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4.2.7 Monitor software. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4.2.8 Watchdog circuitry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4.2.9 Network . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4.2.10 Final cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Monitor battery maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
4.3.1 Use recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
4.3.2 Storage recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
4.3.3 Test the battery charge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
4.3.4 Charge the battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
4.3.5 Condition the battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
4.3.6 Replace the battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Adjustments and calibrations
5.1
5.2
5.3
4
Parameters measurements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
MC or S/5 Network connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Conclusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
24
NIBP calibrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Temperature calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Invasive pressure calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Troubleshooting
1
Introduction
1.1
1.2
1.3
2
Frame troubleshooting
2.1
2.2
3
3.5
3.6
3.7
3.8
4
Battery indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
NET section troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Hemo Troubleshooting
3.1
3.2
3.3
3.4
1
Visual inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
General troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Software troubleshooting chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
9
NIBP troubleshooting flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
ECG troubleshooting flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
STP troubleshooting flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
NIBP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.4.1 NIBP toubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.4.2 NIBP error code explanation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Impedance respiration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Pulse oximetry (SpO2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
iii
Document no. 2081505-001
B40/B20 Patient Monitor
3.9
5
Service Menu
1
Introduction
1.1
1.2
2
3
3.2
3.3
4
5
5.2
5.3
5.4
5.5
5.6
20
Keyboard Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Parameters
5.1
7
Country Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
3.1.1 Languages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Network. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
3.2.1 Network Config (MC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
3.2.2 TCP/IP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
3.2.3 HL7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3.2.4 Dri Config (S/5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3.2.5 Dri Comm (in S/5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3.3.1 Power page. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3.3.2 WPM Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Keyboard
4.1
3
SW Download . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Active Inactive SW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Module SW Upgrade . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Country Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
License. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Enter/Exit Demo Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Frame
3.1
1
Service Menu structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Service Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
SW Management
2.1
2.2
2.3
2.4
2.5
2.6
6
Invasive blood pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
22
Gas Unit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
5.1.1 General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
5.1.2 Gases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
ECG Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
5.2.1 ECG Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
STP Module (for GE SpO2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
5.3.1 Calibrations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
NIBP Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
5.4.1 NIBP Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
5.4.2 NIBP Safety Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
5.4.3 NIBP Pneumatics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
SpO2 (for Masimo/Nellcor SpO2). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Entropy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
6
Set/Test
36
7
Service Log
37
Field replaceable unit
iv
Document no. 2081505-001
1
Spare part
1.1
1.2
1.3
1.4
1.5
1.6
1.7
2
Disassembly
2.1
2.2
2.3
2.4
2.5
2.6
2.7
2.8
2.9
2.10
7
1
Front cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Back cover unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Frame. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Extension rack. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Hemo box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
FRU parts list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Other parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
6
ESD precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Reassembly precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Required tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Before disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
To separate the frame . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
To disassemble the frame. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
To disassemble the extended rack and the recorder. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Handling and storage of display component . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
To replace the fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
To download the software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
E-miniC Module
1
Product overview
1.1
1.2
1.3
1.4
2
Maintenance and checkout
2.1
2.2
2.3
3
3.2
4
13
Sample flow rate adjustment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
3.1.1 Calibration setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
3.1.2 Sample flow rate adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Gas calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3.2.1 Calibration setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3.2.2 Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Troubleshooting
4.1
7
Replacement of planned maintenance parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.1.1 Required parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2.1.2 Replacement procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Visual inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Functional checkout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.3.1 Test setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.3.2 Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.3.3 Test completion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Calibration and adjustments
3.1
1
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Measurement principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.2.1 CO2 measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Main components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.3.1 Gas sampling system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.3.2 MiniC sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.3.3 CPU board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Connectors and signals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
16
Visual inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
v
Document no. 2081505-001
B40/B20 Patient Monitor
4.2
4.3
5
Disassembly and reassembly
5.1
5.2
6
19
Disassembly guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
5.1.1 Serviceable parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
5.1.2 Service limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
5.1.3 ESD precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
5.1.4 Before disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
5.1.5 Tools needed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Disassembly and reassembly procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
5.2.1 Replacing the pump unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
5.2.2 Replacing the miniCO2 assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Service parts
6.1
6.2
8
Troubleshooting checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
4.2.1 Gas sampling system troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
4.2.2 MiniC sensor troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Troubleshooting charts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
22
Ordering parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Spare parts for E-miniC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
E-sCO, E-sCAiO and N-CAiO Modules
1
Product overview
1.1
1.2
1.3
2
Maintenance and checkout
2.1
2.2
2.3
3
3.2
13
Replacement of planned maintenance parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.1.1 Required parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.1.2 Planned Maintenance Kits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.1.3 Replacement procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Visual inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Functional check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
2.3.1 Test setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
2.3.2 Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
2.3.3 Test completion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Calibration and adjustments
3.1
1
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Measurement principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.2.1 CO2, N2O, and agent measurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.2.2 O2 measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Main components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.3.1 Controls and connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.3.2 Gas sampling system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.3.3 MiniTPX measuring unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.3.4 MiniOM Oxygen sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.3.5 CPU board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.3.6 MiniOM board. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
1.3.7 Main Component Interactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
21
Sample Flow Rate Adjustment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.1.1 Calibration setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.1.2 Sample Flow Rate Adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Gas Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
3.2.1 Calibration setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
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3.2.2 Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
4
Troubleshooting
4.1
4.2
4.3
4.4
4.5
5
Disassembly and reassembly
5.1
5.2
6
6.2
9
31
Disassembly guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
5.1.1 Serviceable parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
5.1.2 Service limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
5.1.3 ESD precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
5.1.4 Protection from dust . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
5.1.5 Before disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
5.1.6 Required tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Disassembly and reassembly procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
5.2.1 Disassembly workflow. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
5.2.2 Detaching the Front Cover. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
5.2.3 Detaching the Module Casing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
5.2.4 Replacement of Planned Maintenance Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
5.2.5 Replacement of CO2 Absorber . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
5.2.6 Detaching the Latch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
5.2.7 Detaching the Front Chassis Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
5.2.8 Detaching the Main Flow Connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
5.2.9 Detaching the Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
5.2.10 Detaching the OM holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Service parts
6.1
24
Visual inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Troubleshooting checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
4.2.1 Gas sampling system troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
4.2.2 MiniOM Measuring unit troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
4.2.3 MiniTPX Measuring unit troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
4.2.4 CPU board troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Service Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
4.4.1 Gas measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Troubleshooting charts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
4.5.1 Gas measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
39
Ordering parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
6.1.1 Planned Maintenance Kits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Spare parts for E-sCAiO, E-sCO, N-CAiO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
6.2.1 Front covers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
E-Entropy Module
1
Product overview
1.1
1.2
1.3
1
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Measurement principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.2.1 EntrEEG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.2.2 FEMG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.2.3 RE and SE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.2.4 Impedance measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Main components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.3.1 Controls and connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.3.2 Entropy board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
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Document no. 2081505-001
B40/B20 Patient Monitor
2
Maintenance and checkout
2.1
2.2
2.3
3
Troubleshooting
3.1
3.2
4
4.2
5
10
Disassembly guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
4.1.1 ESD precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
4.1.2 Before disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
4.1.3 Required tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Disassembling and reassembling procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
4.2.1 To replace the front cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
4.2.2 To replace the Entropy board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
4.2.3 Reassembling the module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Service parts
5.1
5.2
8
Visual inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Troubleshooting chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Disassembly and reassembly
4.1
5
Visual inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Electrical safety tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Functional check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.3.1 Test setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.3.2 Entropy tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.3.3 Test completion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
12
Ordering parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Spare parts for E-ENTROPY. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Appendix A:
ElectroMagnetic Compatibility
A-1
Appendix B:
Installation and checkout form, B40/B20
B-1
Appendix C:
Maintenance and checkout form, B40/B20
C-1
Appendix D:
Service check form, E-miniC
D-1
Appendix E:
Service check form, E-sCO, E-sCAiO and N-CAiO
E-1
Appendix F:
Service check form, E-Entropy
F-1
Appendix G:
Networking disclosure to facilitate network risk managment
G-1
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Document no. 2081505-001
1 Introduction
About this manual
Indications for use: B40
This device is a portable multi-parameter unit to be used for monitoring and recording of, and
to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal
patients in a hospital environment and during intra-hospital transport.
The device is intended for use under the direct supervision of a licensed health care
practitioner.
The device is not intended for use during MRI.
The device can be a stand-alone monitor or interfaced to other devices via a network.
The device monitors and displays : ECG (including ST segment, arrhythmia detection), invasive
blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic
and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous
monitoring( including monitoring during conditions of clinical patient motion or low perfusion),
temperature with a reusable or disposable electronic thermometer for continual monitoring
Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardia
l/Core/Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2,
N2O, anesthetic agents, anesthetic agent identification and respiratory rate), and Entropy.
Indications for use: B20
This device is a portable multi-parameter unit to be used for monitoring and recording of, and
to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal
patients in a hospital environment and during intra-hospital transport.
The device is intended for use under the direct supervision of a licensed health care
practitioner.
The device is not intended for use during MRI.
The device can be a stand-alone monitor or interfaced to other devices via a network.
The device monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic
and mean arterial pressure), invasive blood pressure, end-tidal carbon dioxide, heart/pulse
rate, respiration rate, ECG (including arrhythmia and ST segment analysis), temperature with a
reusable or disposable electronic thermometer for continual monitoring
Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardia
l/Core/Surface temperature, and functional oxygen saturation (SpO2) and pulse rate via
continuous monitoring, including monitoring during conditions of clinical patient motion or low
perfusion, and Entropy.
Intended audience
This Technical reference manual is meant for service representatives and technical personnel
who install, configure, maintain, administer, troubleshoot or repair B40/B20 monitor running
the software license VSP-C.
Notes to the reader
As the monitor setup may vary, some functions described may not be available in the monitor
you are using.
•
The order code for the manual is 2081505-001.
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•
Read the manual through and make sure that you understand the procedures described
before the installation of the monitor. To avoid risks concerning safety or health, strictly
observe the warning indications. If you need any assistance concerning the installation,
please do not hesitate to contact your authorized distributor.
Installation without network are allowed by customer. The network installation and service are
allowed by authorized service personnel only.
GE Healthcare assumes no responsibility for the use or reliability of its software in equipment
that is not furnished by GE.
Responsibility of the manufacturer
GE Medical Systems Information Technologies, Inc. (GE) is responsible for the effects on safety,
reliability and performance of the equipment only if:
−
Assembly operations, extensions, readjustments, modifications, or repairs are carried out
by persons authorized by GE.
−
The electrical installation of the relevant room complies with the requirements of the
appropriate regulations.
−
The equipment is used in accordance with the “User's Guide.”
−
The equipment is installed, maintained and serviced in accordance with this manual.
Product availability
Some of the product parts and accessories mentioned in this manual may not be available in
all countries.
Please, consult your local representative for the availability.
Related documentation
−
Clinical aspects, basic methods of measurement and technical background: Patient
Monitor B40/B20 User’s Reference Manual
−
Options and selections of the software: Patient Monitor B40/B20 Default Configuration
Worksheet
−
Compatible supplies and accessories: Patient Monitor B40/B20 Supplies and Accessories
−
Other devices closely related to the monitor:
•
•
•
iCentral and iCentral Client User's Reference Manual
CIC Pro Clinical Information Center Operator's Manual
CARESCAPE Central Station User’s Manual
Manual conventions
To help you find and interpret information easily, the manual uses consistent text formats:

Sign the check form after performing the procedure.
Within this manual, special styles and formats are used to distinguish between terms viewed
on screen, a button you must press, or a list of menu commands you must select:
−
Names of hardware keys on the keypad are written in bold typeface: NIBP
Start/Cancel.
−
Menu items are written in bold italic typeface: Monitor Setup.
−
Emphasized text is in italic typeface.
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−
When referring to different sections in this manual, section names are enclosed in double
quotes: “Cleaning and care”.
−
The word “select” means choosing and confirming.
−
Messages (alarm messages, informative messages) displayed on the screen are written
inside single quotes: 'Learning.'
−
Note statements provide application tips or other useful information.
Monitor naming conventions
In this manual, the B40 Patient Monitor and B20 Patient Monitor are referred to as “the
monitor” when a function or a feature applies to both. For describing monitor-specific issues,
the monitors are referred to as B40 and B20 respectively.
Acquistion module naming conventions
In this manual, the following naming conventions are used to refer to different modules and
module categories:
•
•
•
•
Single-width airway module: E-miniC
CARESCAPE respiratory modules: E-sCO, E-sCAiO
Airway Gas Option: N-CAiO
E-modules: All modules with the prefix E-, In parameter chapters, E-modules refers to
those modules that measure the parameter(s) in question.
Illustrations and names
All illustrations in this manual are only examples, and may not necessarily reflect your system
settings or data displayed in your system. If a particular selection is not available in your
system, the selection is shown grayed.
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1
Overview
The montior is a modular multiparameter patient monitor. The monitor is especially designed
for monitoring in intensive care units. It can also be used during transportation within the
hospital.
The modular design makes the system flexible and easy to upgrade.
NOTE: Your system may not include all these components. Consult your local representative for
the available components.
3
1, 4
2
1.
The monitor frame
2.
E modules: The compatible acquisition modules
3.
Extension rack
4.
Software: VSP-C
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Overview
1.1 Symbols
-
-
On the rear panel:
-
Electric shock hazard. Do not open the cover or the back.
Refer servicing to qualified personnel.
-
For continued protection against fire hazard, replace the fuse
only with one of the same type and rating.
-
Disconnect from the power supply before servicing.
-
Do not use without manufacturer approved mounting.
On the hemo module: Protection against cardiac defibrillator
discharge is due in part to the accessories for pulse oximetry
(SpO2), temperature (T) and invasive pressure (P) measurement
Follow operating instructions
Refer to instruction manual/booklet
Electrostatic sensitive device. Connections should not be made to
this device unless ESD precautionary procedures are followed.
Type BF (IEC 60601-1) protection against electric shock. Isolated
(floating) applied part suitable for intentional external and internal
application to the patient, excluding direct cardiac application.
Type BF (IEC 60601-1) defibrillator-proof protection against electric
shock. Isolated (floating) applied part suitable for intentional
external and internal application to the patient, excluding direct
cardiac application.
Type CF (IEC 60601-1) protection against electric shock. Isolated
(floating) applied part suitable for intentional external and internal
application to the patient, including direct cardiac application.
Type CF (IEC 60601-1) defibrillator-proof protection against electric
shock. Isolated (floating) applied part suitable for intentional
external and internal application to the patient including direct
cardiac application.
In the front panel: battery
Equipotentiality. Monitor can be connected to potential equalization
conductor.
Alternating current
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Audio pause.
Home. Return to the normal screen.
ON/OFF.
Fuse. Replace the fuse only with one of the same type and rating
Gas inlet.
Gas outlet.
IP21
SN,S/N
Degree of ingress protection.
Serial number
Date of manufacture. This symbol indicates the date of
manufacture of this device. The four digits identify the year.
Manufacturer. This symbol indicates the name and the address of
the manufacturer.
European authorized representative.
European Union Declaration of Conformity.
Rx Only U.S.
Prescriptive Device. USA only. For use by or on the order of a
Physician or persons licensed by state law.
Fragile. Handle with care.
Keep dry. Protect from rain.
This way up.
Storage temperature
Humidity limitations.
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Overview
Atmospheric pressure limitations.
Recycled materials or may be recycled.
This symbol indicates that the waste of electrical and electronic
equipment must not be disposed as unsorted municipal waste and
must be collected separately. Please, contact an authorized
representative of the manufacturer for information concerning the
decommissioning of your equipment.
The separate collection symbol is affixed to a battery, or its
packaging, to advise you that the battery must be recycled or
disposed of in accordance with local or country laws. To minimize
potential effects on the environment and human health, it is
important that all marked batteries that you remove from the
product are properly recycled or disposed. For information on how
the battery may be safely removed from the device, please consult
the service manual or equipment instructions. Information on the
potential effects on the environment and human health of the
substances used in batteries is available at this url:
http://www.gehealthcare.com/euen/weee-recycling/index.html
A
B
B
Battery operation and remaining capacity. The height of the green
bar indicates the charging level.
Battery (A) charging (white bar)
Battery (A) failure
B
No battery backup
Battery (A) missing
Submenu. Selecting a menu item with this symbol opens a new
menu.
The monitor is connected to Network.
A blinking heart next to the heart rate or pulse rate value indicates
the beats detected.
A lung next to the respiration rate value indicates that respiration
rate is calculated from the impedance respiration measurement.
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Alarm off indicator - Displays in the digit field and in the Alarms
Setup menu when physiological alarms for this parameter are
turned off.
Audio alarms off indicator - Displays in the upper left corner of the
alarm area when physiological audible alarms are turned off.
Audio alarms paused indicator - Indicates all audio alarms are
paused and the amount of time remaining for the alarm pause
period displays as a countdown timer. Displays in the upper left
corner of the screen.
1.2 Safety information
1.2.1 General
This device is intended for use under the direct supervision of a licensed health care
practitioner.
Contact GE for information before connecting any devices to the equipment that are not
recommended in this manual.
Parts and accessories used must meet the requirements of the applicable IEC 60601 series
safety standards, and/or the system configuration must meet the requirements of the IEC
60601-1 medical electrical systems standard.
Periodically, and whenever the integrity of the device is in doubt, test all functions.
The use of ACCESSORY equipment not complying with the equivalent safety requirements of
this equipment may lead to a reduced level of safety of the resulting system. Consideration
relating to the choice shall include:
•
•
use of the accessory in the PATIENT VICINITY; and
evidence that the safety certification of the ACCESSORY has been performed in
accordance to the appropriate IEC 60601-1.
If the installation of the equipment, in the USA, will use 240V rather than 120V, the source must
be a center-tapped, 240V, single-phase circuit.
1.2.2 Safety message signal words
Safety message signal words designate the severity of a potential hazard.
DANGER: Indicates a hazardous situation that, if not avoided, will result in death orserious
injury. No danger messages apply to this system.
WARNING: Indicates a hazardous situation that, if not avoided, could result in death orserious
injury.
CAUTION: Indicates a hazardous situation that, if not avoided, could result in minor or
moderate injury.
NOTE: Indicates a hazardous situation not related to personal injury that, if not avoided, could
result in property damage.
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Overview
1.2.3 Safety precautions
The following list contains general warnings and cautions you should know before installing,
maintaining or servicing the system. Warnings and cautions specific to the use of the system
can be found in the User’s Guide and User’s Reference Manual.
Warnings
• Use only GE recommended power cords.
• When disconnecting the system from the power line, remove the plug from the wall outlet
first.
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Due to high voltage, use insulated screw driver.
High voltage on test body; do not touch it during the test.
To avoid the risk of electric shock, this equipment must only be connected to a supply
mains with protective earth.
Always check that power cord and plug are intact and undamaged.
All system devices must be connected to the same power supply circuit.
Only interconnect devices when determined safe by qualified biomedical personnel.
Only devices that are specified compliant with IEC 60950-1 or IEC 60601-1 may be
connected to the Ethernet MC ports.
Biomed must determine interconnected parts are safe.
Do not use without manufacturer approved mounting.
If the software package is changed, all clinical settings will reset to factory defaults.
Do not use with iCentral software V5.0.3 and earlier.
Do not use Mobile Care Server software V5.2 and earlier.
Verify compatibility of all system components prior to installation.
Use only approved accessories, including mounts, and defibrillator-proof cables and
invasive pressure transducers. For a list of approved accessories, see the supplies and
accessories list delivered with the monitor. Other cables, transducers and accessories
may cause a safety hazard, damage the equipment or system, result in increased
emissions or decreased immunity of the equipment or system or interfere with the
measurement.
Regular preventive maintenance should be carried out every 24 months.
Do not use multiple modules with identical measurements in the same monitor.
The user may only perform maintenance procedures specifically described in this
manual.
Incorrect power line frequency setting could adversely affect ECG processing.
Make sure patient is not being monitored while servicing the equipment.
Don’t press power key when changing language or doing factory reset.
Never store the monitor with the batteries inside. Storing the monitor with the batteries
inside may result in damage to the monitor.
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Cautions
• Set the time of a newly added network device as close as possible to the time of devices
already on the network.
1.2.4 ESD precautionary procedures
•
To avoid electrostatic charges building up, it is recommended to store, maintain and use
the equipment at a relative humidity of 30% or greater. Floors should be covered by ESD
dissipative carpets or similar. Non-synthetic clothing should be used when working with
the component.
•
To prevent applying a possible electrostatic discharge to the ESD sensitive parts of the
equipment, one should touch the metallic frame of the component or a large metal object
located close to the equipment. When working with the equipment and specifically when
the ESD sensitive parts of the equipment may be touched, a grounded wrist strap
intended for use with ESD sensitive equipment should be worn. Refer to the
documentation provided with the wrist straps for details of proper use.
ESD precautionary procedure training
It is recommended that all potential users receive an explanation of the ESD warning symbol
and training in ESD precautionary procedures.
The minimum contents of an ESD precautionary procedure training should include an
introduction to the physics of electrostatic charge, the voltage levels that can occur in normal
practice and the damage that can be done to electronic components if they are touched by an
operator who is electrostatically charged. Further, an explanation should be given of methods
to prevent build-up of electrostatic charge and how and why to discharge one’s body to earth
or to the frame of the equipment or bond oneself by means of a wrist strap to the equipment or
the earth prior to making a connection.
1.2.5 Disposal
Dispose of the whole device, parts of it and its packing material and manuals in accordance
with local environmental and waste disposal regulations.
1.3 Service information
1.3.1 Service requirements
Follow the service requirements listed below.
•
•
•
Refer equipment servicing to GE authorized service personnel only.
•
Failure on the part of the responsible individual, hospital, or institution using this
equipment to implement a satisfactory maintenance schedule may cause undue
equipment failure and possible health hazards.
•
Regular maintenance, irrespective of usage, is essential to ensure that the equipment will
always be functional when required.
Any unauthorized attempt to repair equipment under warranty voids that warranty.
It is the user's responsibility to report the need for service to GE or to one of their
authorized agents.
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Overview
1.3.2 Equipment identification
Every GE device has a unique serial number for identification. The device plate is located on the
rear of the patient monitor.
Serial number for B40: SKZYYWW****WA
Serial number for B20: SM2YYWW****WA
1.4 Product security
The patient monitoring software incorporates an assortment of security features designed to
allow a flexible approach to safe and secure implementation, focusing on the principles of
confidentiality, integrity, and availability. These features assist you in using the system in a
manner that protects patient privacy and security in your setting, and also addresses
expectations for the environment where the system will be used.
1.4.1 Security features
Access control
Access control is the overall mechanism used to determine and enforce the following:
•
•
•
•
Who has access
How individuals gain access
When access is permitted
What information may be accessed
Other than clinical and service applications, access to other subsystems (for example
bootloader) is restricted. The clinical and service application interfaces have a role-based
access control (for example, biomed and clinical). A user may log into these interfaces to
perform operations that are limited to the generic user. See the user and technical manuals for
detailed information on available features.
Authentication
Authentication is the process of proving individual identity, and is a key element in an access
control system. In the clinical and service applications, there are certain features that require
user authentication. To access these features, the user must log into the clinical and service
applications with a valid username and password.
Authorization
Authorization is the process of granting and revoking access to information, and is another key
element in an access control system. Although primarily an administrative process that is
driven by an organization’s policies and procedures, the patient monitor contains features that
will help implement and enforce an organization’s method. The applications have an
authorization mechanism to provide information to the user.
Audit
The ability to record and examine system activity is crucial to a successful information security
program, as well as a regulatory requirement in most environments. The patient monitor stores
system logs.
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Malicious software protection
Vigilant defense on many levels is required to keep systems free from compromise by
malicious software. Effective protection requires cooperation and partnership between GE and
our customers.
The following product features contribute to defense against malicious software:
•
Device design and configuration (hardening)
The patient monitor has been hardened through the restriction and removal of user
access to core operating system functionality. In addition, unneeded functionality has
been removed or restricted.
•
Antivirus software
To provide seamless real-time patient monitoring, the patient monitor does not have
antivirus software.
•
Security updates and patching processes
Security updates and patches cannot be applied to the product without going through
GE’s vigorous software verification and validation process. Any software update needs
will be communicated by GE.
1.4.2 Security operations
Network security
GE requires that the MC port of the patient monitor be connected to a physically or virtually
dedicated CARESCAPE Network MC, S/5 Network or HL7 Network, isolated from all other
networks.
The monitor uses a defense-in-depth approach protecting the monitor from unauthorized
access via the network. This layered approach leverages internal software firewall and network
isolation.
1.4.3 Product change management
GE has rigorous software verification and validation processes. Any software update needs will
be communicated by GE. The patient monitoring system, including all aspects of software,
should be used as it was intended by GE.
1.4.4 Communication
For detailed product security information, go to one of the following Web addresses:
http://www.gehealthcare.com/usen/security
http://www.gehealthcare.com/usen/security/mds2.html
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System description
2
System description
2.1 Introduction
The monitor build up a freely configurable modular system. The architecture is designed to
enable different module combinations so that the user is able to get the desirable parameter
and feature set. This modular approach makes it possible to add new features when they are
needed.
2.2 Bus structure
The operation of monitor is based on two communication channels, the CPU bus and module
bus. All units, including the modules, receive power from the same power supply, which is an
integral part of the monitor frame.
NAND
Flash
Ethernet
DATA BUS
SDRAM
AT91 ARM
USB HOSE
AT91SA
M7s256
IIC BUS
Sound
RS485
Address bus
LCD
Figure 1
LCD DATA BUS
General bus structure of monitor
The CPU bus is a communication channel used only for internal data transfer. It is based on the
AT91 ARM local bus. Data and address are transferred on this 32 bit wide bus using the CPU
clock frequency.
The module bus is for the parameter modules. The bus is based on the industry standard
RS-485, which uses a differential serial method to transfer data. The module bus uses a 500
kbps data transfer rate.
The RS-485 type of serial communication supports so-called multidrop or party line
connections. This means that all parameter modules connected to the module bus use exactly
the same lines for communication. The advantage of this is that all bus connectors are
identical and the modules can be connected in any order and position.
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2.3 Distributed processing
This is a multiprocessor system. All parameter modules have their own microprocessor, which
performs functions such as waveform filtering, parameter related computing and pneumatic
control, etc. At the same time the main CPU performs higher level tasks such as trending and
alarm control. While the parameter modules and CPU are performing their tasks, the UPI
(Universal Peripheral Interface) microprocessor handles all functions needed to transfer data
between the parameter modules and the CPU.
This kind of parallel processing gives one major advantage to centralized processing. When
new parameter modules are added to the system, the processing power is increased. As a
result, the system does not slow down when new features are added.
2.4 Module communication
The communication master controlling data transfers between the CPU and parameter
modules is called UPI processor. It sends data to each connected module 100 times a second.
Modules respond to each data request immediately by sending a data package, whose length
depends on the type of the module. This communication protocol ensures that each module
receives and sends data every 10 ms. If a module does not respond to data requests, the UPI
processor presumes that the module is disconnected.
The data transfered on USB bus between main CPU and UPI processor.
Marker Out
Main CPU
Figure 2
USB BUS
UPI Processor
Module BUS
Principle of UPI section operation
2.4.1 Serial communication
An RS485 type bus driver makes the serial communication between the module and the frame.
The data transmission rate is 500kbps.
Module Bus (RS-485)
Frame
Hemo
module
Figure 3
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Recorder
E-module
Serial communication between Frame and modules
System description
2.5 Parameter modules
PATIENT
A/D
convert
Peripheral
drivers
Figure 4
CPU
+13...16V
VMOD
RAM
EEPROM
Opto isolation
Data
MODULE BUS
Analog
electronics
Isolation
transformer
Patient isolation
+5V
RS485
drivers
General structure of parameter modules with patient isolation
The detailed structure of a parameter module depends on the specific needs for each
individual parameter. However, some common parts are used in the parameter modules. The
electronics inside the module is usually divided into isolated (floating) and non-isolated
sections. Typically, the non-isolated section consists of buffers to interface the parameter
module to the module bus while the rest of the electronics is located in the isolated section. The
isolated section includes the microcontroller together with memory components, the front-end
analog electronics (amplifiers, etc.) and sensor drivers.
2.6 Software loading
The program memory on the CPU board is loaded with monitor software and selected
language files at the factory. The software is used for running all the functions that are
integrated into the CPU board. For service upgrade main software and language files, please
refer to the 2062416-001: B40/B20 Patient Monitor Software download instruction.
How to do cold start?
The patient monitor performs a cold start, if there is over 15 minutes from the previous power
off. You can perform a cold start by 2 methods:
•
Press ON/OFF button to turn off the monitor, waiting for 15 minutes to turn on the
monitor. Or,
•
Press ON/OFF button for about 15 seconds (until the words “monitor is shutting
downing...“ disappear) to turn off the monitor. Then turn on the monitor.
NOTE: All the patient data and monitor settings will be lost after cold start.
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3
Frame functional description
3.1 Main components
3.1.1 Keypad
User interface parts
The Horizontal Membrane keypad containing 20 keys. The keypads are foil membrane
keypads. The keypads are connected to the UPI section of the CPU board.
Trim Knob is used for menu selection.
3.1.2 Display
The B40 use 12.1” LED backlight display with SVGA 800 x 600 resolution has bright long life light
bar and a wide viewing angle.
The B20 use 10.4” LED backlight display with SVGA 800 x 600 resolution has bright long life light
bar and a wide viewing angle.
Backlights
The backlight of LCD is made up of 1 light bar, LED to be 3020, 20 pieces, 10 serials and 2
parallels. The backlight unit is driven by a separate driver board.
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I/O connector
AC INLET
100-240 Vac
50/60 Hz
Cable or wires
Pin-to-pin connection
Alarm light
board
Speaker
AC/DC
Unit
LCD
display
SVGA
Nurse call
Power Board
LED
driver
board
CPU
Board
Serial data
XY/CW
Module bus
Module bus
Module
interface board
Network
Vmod
BAT2
SMBUS
BAT1
SMBUS
User interface
board
External interface
board
Network
Smart
battery B
Li-ion
9-12.6V
Module bus
connector
CW
Battery board
Smart
battery A
Li-ion
9-12.6V
Module bus
connector
XY
Trim Knob
Keyboard/Memb
rane switch
Power
indicator
Multi I/O
Multi I/O
adaptor
Nurse DFB Serial
call MK out port
Figure 5
Block diagram
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3.1.3 CPU board
The board is based on AT91 ARM microprocessor. Other functions include LVDS display driver,
10/100Mbps on board Ethernet, WLAN communication, Alarm Light function, KEY board and
rotor encoder control, audio driver function, nurse call function, defibrillation function, module
bus function.
The CPU section takes care of the central processing.
The main features are:
•
•
•
•
•
•
AT91 ARM
266 MHz Main CPU clock
64MBytes SDRAM
128 MBytes minimum NAND flash memory
4 MBytes Data flash memory
Main CPU Provides one standard UART communication
Connectors
Ethernet communication connector
WLAN card operation connector
Color LED baclight display operation connector
Audio operation connector
Alarm Light indicator operation connector
Power board connection connector
Voltage supervision
There are two voltage supervision chips that control the system reset signals.
The +3.3V supervision chip outputs reset signals for +3.3V devices. 3.3V Reset Threshold will be
Falling: min 3.00 V; max 3.15 V.
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The +1.2V supervision chip outputs reset signals for +1.2V devices. 1.2V Reset Threshold will be
Falling: min 1.08V; max 1.14 V.
3.1.4
Power board
The Power board converts the output voltage of AC/DC unit and battery voltage to various
supply voltages for the electronics of monitor. The Power board provides monitor system
power function, module bus power function, display backlight power and power failure alarm.
Power board operation is controlled by PMC (Power Management Controller) CPU. PMC takes
care of power path controlling. Power Board incorporates the SMBus interface between the
PMC, battery charger IC, and smart battery.
Power board provides the system voltage for +3.3V, +5V. And Power Board provides 15V power
for measurement modules connected patient monitor module bus.
The Boost converter of PMC system provides module voltage supply for measurement modules
through patient monitor module bus.It operates at input voltage from 9V to15V.
Power Board create an power failure alarm for user to notice unexpected loss of power supply.
It indicate power failure alarm by blinking patient monitor yellow alarm light and buzzer alarm.
Block diagram of the power supplies is represented in following
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MUX
+5V_PMC
ACDC (15V)
Battery Charger
Battery 1
Power Path
Power Management Controller (PMC)
VSYS Enable
Switch
Over Voltage
Protection
(Crowbar)
Battery 2
VSYS
+3.3V
3.3V & 5V Buck
Regulator
15V Boost
Regulator
Figure 6
Power Fail Alarm
+5V
Over Current
Protection & Current
Sense
VMOD
+5V_PMC Linear
Regulator
+5V_PMC
LCD Backlight
Enable Switch
Backlight_VCC
Power board block diagram
Power management controller
The power management controller (PMC) used is the Freescale MC9508AC60CFUE, 8 bit
microcontroller. The PMC is used to:
−
Control power supplies sequencing
−
Monitor the power supply voltages and currents via internal analog to digital converters
(ADCs)
−
Disabling power supplies during fault conditions
−
Communicate with the CPU board via UART communication
−
Read and write to a IIC EEPROM
−
Communicate with smart batteries and a level 2 smart battery charger via SMBus.
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Frame functional description
3.1.5 AC/DC unit
AC/DC unit
The AC/DC unit is a compact medical power supply based on high-efficiency technology. It is
designed for 65 watt continuous output power, universal AC input and 15V output voltage.
AC/DC insulation diagram as follow:
3.1.6 Batteries
The monitor has two lithium-ion batteries, located in the battery compartment. The power
board connects one of the batteries to be the power source, if no power is received from the
AC/DC unit.The battery charging is controlled by the power board.
The batteries can be charged separately, and screen symbols and monitor frame LED
indicators indicate their charging level and possible failure.
NOTE: When the monitor is battery powered, the green battery LED is on. When the monitor is
mains powered, the green mains LED is on.
3.2 Interfacing computer
A computer is connected to the serial port connector on the Multi I/O adapter.
Contact your authorized GE Healthcare distributor for further advice on computer interface.
WARNING
Connecting electrical equipment together or using the same extension cord
for more than one device may cause their leakage currents to exceed the
limits specified in relevant safety standards. Always make sure that the
combination complies with the international safety standard IEC 60601-1
for medical electrical systems and with the requirements of local
authorities.
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WARNING
Connecting the power supply cord of the computer to the wall power outlet
may cause the computer leakage current to exceed the limit specified for
medical equipment. A computer must be supplied from an additional
transformer providing at least basic isolation (isolating or separating
transformer).
3.3 Connectors and signals
3.3.1 External connectors
1
4
6
3
Figure 7
5
7
2
External connectors of Frame
(1)
Receptacle for power cord
(2)
Serial port
(3)
Defibrillator connector
(4)
Nurse call connector
(5)
Network connector
(6)
Equipotential connector
(7)
Multi I/O connector
NOTE: 2,3,4 is on the multi I/O adpter.
Network connector
RJ45 connector
1 2 3 4 5 6 7 8
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Pin
Signal
1
2
3
4
5
6
7
8
Tx +
Tx Rx +
N/C
N/C
Rx N/C
N/C
Frame functional description
Multi I/O connector(26 pin)
26 pin female connector
18
26
10
19
Pin
Signal
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
GND
NC
NC
NC
NC
NC
SERIAL_TXD
SERIAL _CTS#
GND
GND
NC
NC
DEFIB_MARKER_OUT
NC
NC
26
GND
Pin
Signal
1
2
3
GND
NC
Nurse_Call
SERIAL_RXD
SERIAL_RTS#
GND
GND
NURSE_CALL
NC
NC
NC
NC
SERIAL_+3V3
Nurse Call (pin 3)
Nurse call connector
Recommended cable design:
Pin 1
Pin 2 Pin3
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Serial port
9 pin female connector
Pin
Signal
1
2
3
4
5
6
7
8
9
GND
SERIAL_TXD
SERIAL_RXD
N/C
GND
N/C
SERIAL_CTS
SERIAL_RTS
N/C
Pin
Signal
L
Live
PE
Protected earth
N
Neutral
Female mini din7 connector Pin
Signal
5
1
9
6
Main power
Mains connector
Defib connector (Pin 7)
1
2
3
4
5
6
7
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GND
GND
GND
GND
DEFIB_MARKER_OUT
NC
GND
Hemo-dynamic module introduction
4
Hemo-dynamic module introduction
The hemo module provide general hemodynamic parameters.
Figure 8
Hemo module
4.1 Monitor software compatibility
−
The monitor using software VSP-C
4.2 Main components
4.2.1 Hemo-dynamic module
1
2
3
1. InvBP connector
2. Temperature connector
3. SpO2 connector
4. ECG connector
5. NIBP connector
4
5
Figure 9
Front panel of hemo module
The Hemo-dynamic module including the NIBP measurement, 5-lead ECG with the Impedance
Respiration measurement, SpO2 with the plethysmographic waveform, two invasive pressure
measurements (IBP1 and IBP2) and two temperature measurements (T1 and T2).
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The monitor displays waveforms and measurement readings, and handles the trending and
alarm management. The ECG (e.g. heart beat and arrhythmia detection) and the Impedance
Respiration algorithms are in the monitor software. The modules measure signals and send
them to the monitor. The NIBP, SpO2, Temperature and Invasive Pressure algorithms are in the
module.
There are four parameter circuit boards inside the hemo-dynamic module for processing the
measurement signals. Each processing board has a microcontroller with software.
The NIBP parameter measurement requires one signal processing board, pneumatic system,
valve and pump unit connected to NIBP parameter board.
The second parameter board is the optional board, for Nellcor or Masimo SpO2 measurement,
it’s Masimo MS-2011 board or Covidien NELL1GE-S board at different configuration.
The third parameter board is for GE SpO2, IBP and Temperature measurement including input
board. All these three parameter is optional, according to different configuration, using
different board: it’s STP board, TP board for Nellcor, TP board for Masimo, GE SpO2 board.
The fourth parameter board is for 3/5-lead ECG with the Impedance Respiration measurement
including ECG input unit connected to the ECG parameter board.
All parameter boards are connected together via module bus flex board connecting voltage
and module communication, the module communicates with frame through RS-485 bus.
4.2.2 Signals and isolation barrier
The communication signals transfer over the isolation barrier by using high isolation voltage
(6kV) opto isolators.
4.2.3 Power supply section
The power for the electronics on the floating part of the STP and the ECG boards is made on
each board with the switching power supplies connected to a high voltage isolated
transformer. The switching power supplies on the STP and ECG boards are synchronized to the
frequency, about 172.8 kHz of the switching power supply on the NIBP board. The NIBP board
supplies non-isolated 5 V to the ECG and STP boards. The module uses only Vmod 15V +/- 3%
of the frame. The other voltages of the measuring boards are made by the switching power
supplies and regulators or the linear regulators. Each measuring board is protected against
overloading with PTC type automatic fuses.
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4.2.4 NIBP board
EEPROM
1024Bytes
Module bus connector
Main CPU
AT91SAM7S256
RS485
interface
Pneumatic
control
Pump
connector
Valves
connector
256KBytes Flash
64KBytes SRAM
10bits ADC
PWR_
SYN
Pressure
sensor
NIBP_+5V
6VD
Power supply
MAIN_REF
Safety CPU
MSP430F2013
2KB+256B Flash
128B RAM
16bits SigmaDelta ADC
Figure 10
NIBP board functional block diagram
Signal processing
Two signals from the pressure transducers are amplified and sent to the A/D converter. After
the converter, digitized signals are sent to the microprocessor for data processing.
The NIBP board is controlled with an ARM7 microprocessor at 16 MHz oscillator frequency.
Memory
The NIBP program memory (processor flash memory) size is 256k x 8. The processor has 64
kBytes RAM. The EEPROM size is 8K x 8 and it is used to store the calibration values for the
pressure transducers, the pulse valve constants gained during measurements, the PC board
identification, and the module serial number.
Software control
The software controls valves and a pump. In addition to the individual on/off signals for each
component there is a common power switch for the valves and the pump that can be used at
pump/valve failures.
Safety circuit
The NIBP board is equipped with an independent safety circuit to disconnect supply voltages
from the pump and the valves if the cuff has been pressurized longer than the preset
maximum measurement time, or if the pressure of the cuff is inflated over the specified
pressure limit. The maximum measurement time values and pressure limits for different
measurement modes have been specified in the technical specification section of this manual.
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Pneumatics
1
7
5, 6
3
2
4
1
The module has the following pneumatics parts:
5.
Intake air filter; for preventing dust and other parts from entering the air pump and the
valves.
6.
Air pump; for pumping the measuring pressure of the cuff.
7.
Deflation Valve; for producing a linear pressure fall (bleeding) in order to measure the
blood pressure of the patient.
8.
Safety valve/Dump valve; The Safety valve/Dump valve is intended to be used for
deflating the cuff in single fault case, i.e. to prevent too long a measurement time or too
high an inflation pressure of the cuff.
9.
Main pressure sensor; for measuring the pressure of the blood pressure cuff and the
pressure fluctuations caused by arterial wall movement.
10.
Second pressure sensor; for detecting the, cuff loose, cuff occlusion situations, etc. and
for recognizing the pressure sensor fault.
11.
Cuff connector; for connection and hose identification.
Power supply section of the NIBP board
All connections are established via a 10-pin connector (male). The module needs a +15 V (dirty)
power supply to operate. The supply voltage Vmod 15V +/- 3% is generated in the power
supply section of the monitor. The other voltages needed for the operation of the NIBP
measurement are made on the NIBP board.
The NIBP power supply synchronizes the ECG and STP isolation power and supplies
non-isolated 5 V to the ECG and STP board.
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4.2.5 ECG board in 5-lead measurement
The ECG measurement consists of the functions shown in Figure 11. All functions are located in
the ECG board except the ECG input unit.
PATIENT AND ECG ELECTRODES
ECG CABLE
- ECG LEAD SET
- ECG TRUNK CABLE
ECG INPUT UNIT
- ECG CONNECTOR
- INPUT PROTECTION RESISTORS
INPUT PROTECTION DIODES FOR ECG & RESPIRATION MEASUREMENT
INPUT FILTERING FOR ECG & RESPIRATION MEASUREMENTS
RESPIRATION
MEASUREMENT
AMPLIFIERS
RESPIRATION
MEASUREMENT
CURRENT SUPPLY
ECG
PREAMPLIFIERS &
RLD CIRCUIT
LEADS OFF &
PACER &
DEFIBRILLATION
DETECTION
BASELINE
RESTORATION
RS 485
COMMUNICATION
POWER SUPPLY
ISOLATION
ISOLATION
MODULE BUS CONNECTOR
Figure 11
NV
MEMORY
ECG BLOCK DIAGRAM
12_lead_ECG_meas_blck_dgrm.vsd
ECG CPU
ECG measurement block diagram
ECG input unit
The ECG input unit consists of the front panel connector and the ECG input connector board
with the high voltage protection resistors. The connector for the ECG cable is a green 11-pin
rectangle shaped connector.
Input protection and filtering
The input protection is implemented with high voltage protection resistors in the ECG input unit
and with protection diodes in the ECG board. The input filtering for ECG measurement is done
with passive RC filtering.
ECG preamplifiers
The buffer amplifiers are used for each lead. The “Leads off” detection is implemented by
measuring the output level of the input buffer amplifiers with the A/D converter of the CPU. The
ECG signals are measured using differential amplifiers.
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ECG amplifiers and baseline restoration
The function of the ECG amplifiers and baseline restoration is to amplify the signal and to
restore the baseline of the signal in the middle of the display after the change of the signal
level, e.g. after the change of the DC offset voltage.
Pacemaker detection
Pacer detection has been made by using four slew rate detector circuits. The pacer detection
amplifiers have been realized at the front of the slew rate detectors independently of the ECG
measuring channels.
Respiration impedance supply
The 31.25 kHz sine wave generator is used as the respiration measurement signal supply.
Analog switches are used for connecting the sine wave to the ECG leads to be measured.
Respiration impedance amplifiers
Buffer amplifiers are used in respiration measurement. Analog switches are used for selecting
the measurement leads. There are also additional amplifiers for increasing the respiration
signal gain. When ECG measurement is 5-lead, the respiration measurement is always done
between R and F, independently on the ECG lead selection. When ECG measurement is 3-lead,
then the respiration measurement is happened at the same lead as the ECG measurement (I, II
or III).
ECG CPU
The CPU is a 16 bit H8/3052 single-chip microcomputer. It contains 128 kbytes of flash memory
and 4 kbytes of RAM. The clock frequency is 16 MHz.
RS485 communication
The communication to the CPU board of the monitor uses RS485 protocol. The RS485 driver
circuits are optically isolated from the processor of the module.
Power supply
The ECG board has a driver-controlled half-bridge switching power supply with 5 kV isolation.
The supply voltages have been regulated with linear regulators.
ECG filtering
B40 monitors have three ECG filtering modes:
MONITORING
DIAGNOSTIC
ST FILTER
0.5 to 40 Hz
0.05 to 150 Hz
0.05 to 40 Hz
The purpose of filtering is to reduce high frequency noise and low frequency (e.g. respiratory)
movement artifacts.
The monitor filter is used in normal monitoring. The diagnostic filter is used if more accurate
diagnostic information is needed. The ST filter gives more accurate information of ST segment,
but reduces high frequency noise.
The high-pass filters 0.5 Hz and 0.05 Hz are done with software. The monitor sends a command
to the hemodynamic module determining which of the corner frequencies 0.5 Hz or 0.05 Hz is
to be used.
The 50 Hz and 60 Hz reject filters are both low-pass filters with zero at 50 Hz or 60 Hz
correspondingly. They are software based filters used for the mains supply filtering.
In diagnostic mode the upper frequency is 150 Hz and it is limited by software.
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4.2.6 STP board
STP module measures SpO2, two channels of temperatures and two channels of invasive blood
pressures.
The SpO2 measurement is made optically with an infrared light, a red light sources, and a
photosensitive detector. The SpO2 value and Pulse Rate are calculated based on the signals,
which are measured with the photosensitive detector in the SpO2 sensor. There are three
configurations of SpO2: GE SpO2, Masimo SpO2 and Nellcor SpO2. There are four kinds of STP
parameter board:
−
GE SpO2 board
−
STP board, integrated GE SpO2, Temperature and pressure
−
TP board, integrated Temperature and pressure, communicated with Masimo OEM SpO2
through UART port to get SpO2 data and send to host.
−
TP board, integrated Temperature and pressure, communicated with Nellcor OEM SpO2
through UART port to get SpO2 data and send to host.
The temperature measurement is designed for use with YSI-400 series NTC sensors.
The Invasive Pressure measurement is designed for use with the bridge type medical pressure
sensors.
Refer to the following block diagram.
PATIENT AND SpO2 PROBE
PATIENT AND TEMPERATURE SENSOR
PATIENT AND INVASIVE CANNULA OR
CATHETER
SpO2 TRUNK CABLE
TEMPERATURE CONNECTOR
FLUSHING KIT & INVASIVE PRESSURE
SENSOR WITH DOME
SpO2 CONNECTOR
INPUT PROTECTION CIRCUITRY
INV.PRESSURE CONNECTOR
SpO2 PROBE RECOGNITION & LED
DRIVE SELECTION MATRIX
TEMPERATURE
MEASUREMENT
AMPLIFIER
SpO2 LED
DRIVE
SENSOR SIGNAL
CURRENT
SOURCE
INV: PRESSURE
MEASURE MENT
AMPLIFIER
SENSOR SIGNAL
VOLTAGE
SOURCE
SpO2
AMPLIFIER
A/D CONVERSION
RS 485
COMMUNICATION
POWER SUPPLY
ISOLATION
ISOLATION
MODULE BUS CONNECTOR
Figure 12
NV
MEMORY
STP BLOCK DIAGRAM
STP_brd_blck_dgrm.vsd
STP CPU
STP block diagram
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PATIENT AND SPO2 PROBE
PATIENT AND TEMPERATURE SENSOR
PATIENT AND INVASIVE CANNULA OR
CATHETER
SPO2 TRUNK CABLE
TEMPERATURE CONNECTOR
FLUSHING KIT & INVASIVE PRESSURE
SENSOR WITH DOME
SPO2 CONNECTOR
INPUT PROTECTION CIRCUITRY
INV.PRESSURE CONNECTOR
TEMPERATURE
MEASUREMENT
AMPLIFIER
SENSOR SIGNAL
CURRENT
SOURCE
INV: PRESSURE
MEASUREMENT
AMPLIFIER
SENSOR SIGNAL
VOLTAGE
SOURCE
MASIMO OR NELLCOR SPO2 MODULE
A/D CONVERSION
TEMPERATURE AND IBP CPU
NV MEMORY
POWER SUPPLY
ISOLATION
RS 485
COMMUNICATION
ISOLATION
TP +Masimo or Nellcor SPO2
BLOCK DIAGRAM
MODULE BUS CONNECTOR
Figure 13
TP board block diagram
Microprocessor unit
The CPU is a 16 bit H8/3052 single-chip microcomputer. It contains 128 kbytes of flash memory
and 4 kbytes of RAM. The clock frequency is 16 MHz.
High speed I/O is used to obtain a pulse control sequence necessary for pulse oximetry
measurement. Timing for the clock is from the oscillator.
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Temperature measurement unit
The NTC-resistor value in the probe depends on the patient’s temperature. It is measured with
the following principle described below.
The constant current source is supplied about 38 μA current through the temperature sensor
(YSI 400-series NTC resistor). The constant current is caused a voltage over the temperature
sensor (NTC resistor). The voltage over the temperature sensor is amplified in a differential
amplifier stage. The amplified voltage is transferred to a controller of the STP board through an
A/D converter.
constant
current
source
Defibrillation/ESD protection
resistors and diodes
Temperature
sensors T1, T2
Ref1
Ref2
T2
R
R
R
0C:7k36
15C:3k54
25C:2k53
38C:1k30
45C: 984
R
R
Figure 14
Differential
amplifier
d/dt
0
0
0
To A/D
converter
0
PSM_temp_meas_principle.vsd
T1
R
Temperature measurement principle
Invasive blood pressure measurement unit
An isolated +5 V voltage is supplied to the pressure transducer. The differential voltage, which
depends on the pressure and the supplied voltage, is calculated from the bridge connection
(see the formula below).
Uout = Uin × pressure × 5 μV, where Uin is 5 V
 Uout = 25 μV × pressure [mmHg]
Pressure amplification is realized in the instrumentation amplifier. The gain of the amplifier is
set to keep the level of the signal transferred to the A/D converter within the measurement
range even when there are circumstantial offsets or offsets caused by the transducer. There is
a filter before the amplifier to attenuate high frequency disturbances.
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Vin
Current
measurement
G
to AD converter
Pressure
transducer
Vout
Input filter
G
to A D converter
Figure 15
PSM_pressure_meas_principle.vsd
Instrum entation
amplifier
Pressure measurement principle
Pulse oximetry measurement section
LED control signals
The D/A converters of the microcontroller on the STP board set the LED intensity adjustment
values for the infrared and red LEDs of the SpO2 probe. The microcontroller on the STP board
switches ON (to the adjusted intensity) and OFF the SpO2 probe LEDs according to the
predetermined sequence.
LED driving circuit
Differential amplifiers measure the LED currents (LED current indication) of the SpO2 probe over
the shunt resistors placed in the LED current paths. The LED driving voltages (LED voltage
indication) are measured from the driver circuitry. The LED driving circuits also have MOSFET
transistor matrix to enable the use of different probe configurations.
Measured signal preamplification
The preamplifier is a bipolar/single-ended current-to-voltage converter with adjustable gain. A
higher gain is used for measuring thin tissue. The preamplification stage has also ambient light
reduction and a second amplifier stage.
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LED Driving circuit 1
LED Intensity adjustment 1
LED ON/OFF control 1
LED voltage indication 1
LED current indication 1
LED Driving circuit 2
LED Intensity adjustment 2
LED ON/OFF control 2
LED voltage indication 2
SpO2
Probe
LED current indication 2
LP
Oximeter channel 1
Gain=7.5
DCsuppression
LP
Oximeter channel 2
Gain=7.5
Ambient reduction
LP
Amplifier:
Gain = 2
Oximeter channel 3
Gain=7.5
DCsuppression
Oximeter channel 4
LP
DE-MUX
Analog
Figure 16
Amplifiers
Digital
Spo2_measurement_blck_diagr.vsd
Preamplifier:
Current-to-voltage type
Bipolar/single-ended modes
Adjustable gain
DCsuppression
GE Pulse oximetry measurement block diagram
Red and infrared channel separation
It is possible to multiplex the detector signal to four different channels depending on the
content of the signal. The detector signal must at least multiplex into infrared and red signals.
Other channels are e.g. for diagnostic purposes.
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4.3 Connectors and signals
4.3.1 Front panel connectors
Table 6
ECG connector
ECG Connector
Table 7
Document no. 2081505-001
Signal Name
1
2
3
4
5
6
7
8
9
10
11
R/RA; Right arm electrode
C2/V2; Chest electrode
C3/V3; Chest electrode
L/LA; Left arm electrode
N/RL; Neutral/Right Leg Drive electrode
C1/V1; Chest electrode
C4/V4; Chest electrode
F/LL; Left Leg electrode
C6/V6; Chest electrode
C5/V5; Chest electrode
Cable Shield
SpO2 connector
SpO2 connector
1-36
Pin No.
Pin No.
Signal
Description
1
DET_A
Photodiode anode
2
DET_C
Photodiode cathode
3
DATA-
4
Wire 1/3
LED connection
5
IR_C
IR LED cathode
6
OUTER SHIELD
7
DET_SHIELD
8
PRB_ID
Bin/ID Resistor+
9
Wire 3/5
LED Connection
10
RED_C
RED LED cathode
11
DATA+
Hemo-dynamic module introduction
Table 8
Invasive blood pressure connectors (IBP1, IBP2)
Invasive blood pressure
connectors (Dual BP)
Table 9
Pin
No.
Signal
Description
1
BP_+VREF BP transducer excitation voltage, channel
1
2
BP SIG+
3
BP_+VREF BP transducer excitation voltage, channel
2
4
AGND
Analog ground
5
BP SIG+
BP transducer signal positive (+), channel
2
6
SHIELD
BP cable shield
7
AGND
Analog ground
8
BP SIG1
BP transducer signal negative (-), channel
1
9
BP SIG2
BP transducer signal negative (-), channel
2
10
BP1_ID
BP1 probe identification
11
NC
Not connected
BP transducer signal positive (+), channel
1
Temp connector (T1, T2)
Temp connector
Pin No
Signal
1
Sensor drive current
2
Input from temperature sensor, channel 1
3
Not connected
4
Not connected
5
Thermistor ID (LOW= Temperature error,
HIGH=YSI 400 series)
6
Cable shield
7
Analog ground
8
Input from temperature sensor, channel 2
9
Not connected
10
Not connected
11
Digital ground
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4.4 Measurement principle
4.4.1 NIBP
NIBP (Non-Invasive Blood Pressure) is an indirect method for measuring blood pressure.
The NIBP parameter conforms to EN1060-1:1995/A2:2009 Specification for Non-invasive
sphygmomanometers.
The NIBP measurement is performed according to the oscillometric measuring principle. The
cuff is inflated with a pressure slightly higher than the presumed systolic pressure, and deflated
at a speed based on the patient’s pulse, collecting data from the oscillations caused by the
pulsating artery. Based on these oscillations, values for systolic, mean, and diastolic pressures
are calculated.
The following parts are necessary for the NIBP measurement:
•
•
•
hemo module
twin hose (adult or infant model)
blood pressure cuffs (various sizes)
4.4.2 ECG
Electrocardiography analyzes the electrical activity of the heart by measuring the electrical
potential produced with electrodes placed on the surface of the body.
ECG reflects:
•
•
•
•
electrical activity of the heart
normal/abnormal function of the heart
effects of anesthesia on heart function
effects of surgery on heart function
See the “User's Guide” or the “User’s Reference Manual” for electrodes’ positions and other
information.
4.4.3 Pulse oximetry
A pulse oximeter measures the light absorption of blood at two wavelengths, one in the near
infrared (about 940 nm) and the other in the red region (about 660 nm) of the light spectrum.
These wavelengths are emitted by LEDs in the SpO2 probe, the light is transmitted through
peripheral tissue and is finally detected by a PIN-diode opposite the LEDs in the probe. The
pulse oximeter derives the oxygen saturation (SpO2) using an empirically determined
relationship between the relative absorption at the two wavelengths and the arterial oxygen
saturation SaO2.
In order to measure the arterial saturation accurately, pulse oximeters use the component of
light absorption giving variations synchronous with heart beat as primary information on the
arterial saturation.
A general limitation of pulse oximetry is that due to the use of only two wavelengths, only two
hemoglobin species can be discriminated by the measurement.
The modern pulse oximeters are empirically calibrated either against fractional saturation
SaO2frac;
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HbO2
HbO2 + Hb + Dyshemoglo bin
SaO2 frac =
Formula 1
or against functional saturation SaO2func;
SaO 2 func =
HbO 2
HbO 2 + Hb
Formula 2
Functional saturation is more insensitive to changes of carboxyhemoglobin and
methemoglobin concentrations in blood.
The oxygen saturation percentage SpO2 measured by the Datex-Ohmeda module is calibrated
against functional saturation SaO2func. The advantage of this method is that the accuracy of
SpO2 measurement relative to SaO2func can be maintained even at rather high concentrations
of carboxyhemoglobin in blood. Independent of the calibration method, pulse oximeters are
not able to correctly measure oxygen content of the arterial blood at elevated
carboxyhemoglobin or methemoglobin levels.
Plethysmographic pulse wave
The plethysmographic waveform is derived from the IR signal and reflects the blood pulsation
at the measuring site. Thus the amplitude of the waveform represents the perfusion.
Pulse rate
The pulse rate calculation is done by peak detection of the plethysmographic pulse wave. The
signals are filtered to reduce noise and checked to separate artifacts.
Intensity of
transmitted
light
Imax (DC-component)
Imax
Imin
AC-component
Variable absorption
due to pulse added
volume of arterial
blood
Transmitted
light
Arterial blood
Tissue
No pulsation
Pulsatile blood
Time
absorption_of_light.vsd
Venous blood
Incident light
Figure 17
Absorption of infrared light in the finger
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SpO2 sensor connector
RED
Detector
Figure 18
PSM_absorption_of_infrared.vsd
IRED
Emitter
Pulse oximetry probe parts layout and schematic diagram
The standard probe is a finger clamp probe which contains the light source LEDs in one half
and the photodiode detector in the other half. Different kinds of probes are available from GE
Healthcare.
Summary of clinical studies used to establish the SpO2 accuracy claims
NOTE: The pulse oximeter equipment measurements are statistically distributed, only about
two-thirds of pulse oximeter equipment measurements can be expected to fall within ±Arms of
the value measured by a CO-oximeter. The CO-oximeter should have a SaO2 accuracy of 1% (1
standard deviation) or better over the range of which the manufacturer makes SpO2 accuracy
claims. A controlled desaturation study supporting a claimed range of SpO2 accuracy from 70
to 100% SaO2 can be supported with SaO2 data collected over the range of 73 to 97% SaO2.
Nellcor Oximax Technology with Oximax sensors
Measurement modules using Nellcor Oximax Technology with Oximax sensors have been
validated for no motion accuracy in controlled hypoxia studies with healthy nonsmoking adult
volunteers over the specified saturation SpO2 range(s). Pulse oximeter SpO2 readings were
compared to SaO2 values of drawn blood samples measured by hemoximetry. Subjects used
to validate SpO2 measurement accuracies were healthy and recruited from the local
population. Subjects comprised both adult men and women and spanned a range of skin
pigmentations. Because scatter and bias of pulse oximeter SpO2 and blood SaO2 comparisons
commonly increase as the saturation decreases, and accuracy specifications are calculated
from data spanning the stated range, different accuracy values may result when describing
partially overlapping ranges. When sensors are used on neonatal subjects as recommended,
the specified accuracy range is increased by ± 1 digit, as compared to adult usage, to account
for the theoretical effect on oximeter measurements of fetal hemoglobin in neonatal blood.
Masimo SET Technology with LNOP and LNCS sensors
Measurement modules using Masimo SET Technology with LNOP and LNCS sensors have been
validated for no motion accuracy in human blood studies on healthy adult volunteers in
induced hypoxia studies in the range of 70-100% SpO2 against a laboratory co-oximeter and
ECG monitor. Subjects comprised both adult men and women and spanned a range of skin
pigmentations. One percent was added to accuracies for neonatal/infant sensors to account
for accuracy variation due to properties of fetal hemoglobin. Refer to the directions for use of
the Masimo SET sensors.
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Hemo-dynamic module introduction
GE Trusignal Technology sensors
Measurement modules using GE Trusignal Technology with OxyTip+/Trusignal sensors have
been validated for no motion accuracy in controlled hypoxia studies with healthy nonsmoking
adult volunteers over the specified saturation SpO2 range(s). Pulse oximeter SpO2 readings
were compared to SaO2 values of drawn blood samples measured by hemoximetry. Subjects
comprised both adult men and women and spanned a range of skin pigmentations.
GE Oxy-AF and GE Oxy-SE sensors have been validated for neonatal accuracy. The subject
demographics included 28 neonatals and 1 infant (15 females and 14 males). The subjects
ranged in age from newborn to 37 days old. The weights ranged from 560 to 3060 g. The skin
tones included in the study were light to dark. For neonatal study, the Arms of the collected
convenience samples are 2.7, Oxy-AF sensor in the SaO2 range of 87-100% collected 52 data
points, Oxy-SE sensor in the SaO2 range of 81-100% collected 53 data points.
Test methods used to establish the accuracy claims during low perfusion
Nellcor Oximax Technology with Oximax sensors
Nellcor Oximax Technology with Oximax sensors have been validated for SpO2 low perfusion
accuracy in bench top testing using Nellcor's PS II simulator with signal strength setting of
0.03% modulation and oxygen saturation levels of 70 to 100% at a pulse rate of 90 BPM.
Nellcor Oximax Technology with Oximax sensors have been validated for low perfusion pulse
rate accuracy in bench top testing using Nellcor's PS II simulator at a simulated low perfusion
level of 0.10% modulation in the pulse rate range of 40 to 250 beats per minutes (BPM) at a
SpO2 of 95%.
Masimo SET Technology with LNOP and LNCS sensors
Masimo SET Technology with LNOP and LNCS sensors have been validated for low perfusion
accuracy in bench top testing against Biotek Index 2 Simulator and Masimo's simulator with
signal strength setting of greater than 0.02% and a % transmission of greater than 5% for
saturation ranging from 70%-100%. One percent was added to accuracies for neonatal/infant
sensors to account for accuracy variation due to properties of fetal hemoglobin.
Test methods used to establish the accuracy claims during motion
Masimo SET Technology with LNOP and LNCS sensors
Masimo SET Technology with LNOP and LNCS sensors have been validated for motion
accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies while
performing rubbing and tapping motions, at 2 to 4 Hz at an amplitude of 1 to 2 cm and
non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in the range of 70% to
100% SpO2 compared against a laboratory COoximeter and ECG monitor. The variation equals
plus or minus one standard deviation, which encompasses 68% of the population. One percent
was added to accuracies for neonatal/infant sensors to account for accuracy variation due to
properties of fetal hemoglobin.
NOTE: Accuracy during motion has not been specified for Masimo SET sensors LNOP TC-I, LNCS
TC-I and LNCS TF-I.
GE Trusignal Technology sensors
Measurement modules using GE Trusignal Technology with TS-AF and TS-AP sensors have
been validated for motion accuracy in controlled hypoxia studies with healthy non-smoking
adult volunteers over the specified saturation SpO2 range(s). The following motion types were
used: mechanically induced 3 Hz tapping motion at an amplitude of 1-2 cm, patient induced
non-repetitive rubbing motion, and patient induced non-repetitive hand motion in supine
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position. Pulse oximeter Sp02 readings were compared to SaO2 values of drawn blood samples
measured by CO-oximetry. Subjects comprised both adult men and women and spanned a
range of skin pigmentations.
Test methods used to establish pulse rate accuracy
Nellcor Oximax Technology with Oximax sensors
Nellcor Oximax Technology with Oximax sensors have been validated for pulse rate accuracy
in bench top testing using Nellcor's PS II simulator over the specified range at a SpO2 of 95%.
Masimo SET Technology with LNOP and LNCS sensors
Masimo SET Technology with LNOP and LNCS sensors have been validated for pulse rate
accuracy over the specified range in bench top testing against a Biotek Index 2 simulator.
GE Trusignal Technology sensors
Measurement modules using GE Trusignal technology sensors have been validated for pulse
rate accuracy over the specified range in bench top testing against a patient simulator.
4.4.4 Temperature
The temperature is measured by a probe whose resistance varies when the temperature
changes, called NTC (Negative Temperature Coefficient) resistor.
The resistance can be measured by two complementary methods:
•
Applying a constant voltage across the resistor and measuring the current that flows
through it.
•
Applying a constant current through the resistor and measuring the voltage that is
generated across it.
Hemo module uses the constant current method. The NTC-resistor is connected in series with a
normal resistor and a constant current is applied through them. The temperature dependent
voltage can be detected at the junction of the resistors, thus producing the temperature signal
from the patient. The signal is amplified by analog amplifiers and further processed by digital
electronics.
4.4.5 Invasive blood pressure
To measure invasive blood pressure, a catheter is inserted into an artery or vein. The invasive
pressure setup, consisting of a connecting tubing, a pressure transducer, an intravenous bag
of normal saline, all connected together by stopcocks, is attached to the catheter. The
transducer is placed at the same level with the heart, and is electrically zeroed.
The transducer is a piezo-resistive device that converts the pressure signal to a voltage. The
monitor interprets the voltage signal so that pressure data and pressure waveforms can be
displayed.
4.4.6 Respiration
Impedance respiration is measured across the thorax between ECG electrodes. The respiration
signal is made by supplying current between the electrodes and by measuring the differential
current from the electrodes. The signal measured is the impedance change caused by
breathing. The respiration rate is calculated from these impedance changes, and the
respiration waveform is displayed on the screen.
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Hemo-dynamic module introduction
Description of test method, data rate and method of ET-calculation
The module uses concentration waveforms with data rate of 25Hz to calculate end-tidal (ET)
gas readings.
The module finds the time instant of the highest CO2 concentration in breath. Concentration at
that instant is the ET CO2 reading. Because nitrous oxide and anesthetc agents are measured
by the same sensor as CO2, the ET-readings of those gases are obtained directly at the time
instant of ET CO2. For calculating ET-reading of O2 is then determined as O2-concentration at
the time instant of ET CO2. If no breaths are detected for a given time (20s, for example), an
apnea situation is triggered. During apnea, the ET values are updated every two seconds to the
current concentration of each gas.
The rated respiration rate range and the corresponding end-tidal gas reading accuracy were
tested with reference gases of known concentrations. The test gases ware fed to the gas
sampling system of the module through on electrically actuated valve with very low internal
volume. Depending on its actuation status, the valve directed either room air or a test gas to
the gas sampling line. The desired respiration rates were set by the electrical actuating times of
the valve.
The measurement accuracy of the end-tidal gas readings was tested using gas sampling lines
of 3 meter length, connected to the gas sample port on the D-fend Pro water trap. The gas
sampled to the sampling line was switched from room air to the test gases using on electrically
actuated valve with low internal dead space to generate step changes in the gas
concentrations. The electric actuating signal of the valve was generated using a highly
accurate singal generator to accurately control the simulated respiration rate.
The electronic sampling rate of the gas sensor signals is 25Hz, equaling a new data point on
the gas waveform traces every 40 milliseconds.
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2 Hardware
installation
Installation
1
Installation
Safety precautions
Warnings
•
The monitor or its components should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the monitor and its components
should be observed to verify normal operation in the configuration in which it will be used.
•
After transferring or reinstalling the monitor, always check that it is properly connected
and all parts are securely attached. Pay special attention to this in case of stacked
mounting.
•
•
•
Use only manufacturer approved mounts.
•
EXPLOSION OR FIRE -Using non-recommended batteries could result in injury/burns to
the patients or users. Only use batteries recommended or manufactured by GE.
•
Do not incinerate a battery or store at high temperatures. Serious injury or death could
result.
•
Allow temperature of the monitor to stabilize to operating temperature range before
connecting to power line.
•
NETWORK INTEGRITY — The monitor resides on the CARESCAPE, S/5 network. It is possible
that inadvertent or malicious network activity could adversely affect patient monitoring.
The integrity of the network is the responsibility of the hospital.
•
INTERFACING OTHER EQUIPMENT - Devices may only be interconnected with each other
or to parts of the system when it has been determined by qualified biomedical personnel
that there is no danger to the patient, the operator, or the environment as a result. In
those instances where there is any element of doubt concerning the safety of the
connected devices, the user must contact the manufacturers concerned (or other
informed experts) for proper use. In all cases, safe and proper operation should be verified
with the applicable manufacturer’s instructions for use, and system standards IEC
60601-1 must be complied with.
•
The medical electrical equipment or medical electrical system may be interfered with by
other equipment, even if that other equipment complies with CISPR EMISSION
requirements.
Don’t install the monitor above the patient.
Do not use the monitor in high electromagnetic fields (for example, during magnetic
resonance imaging).
Cautions
•
The monitor display is fragile. Ensure that it is not placed near a heat source or exposed to
mechanical shocks, pressure, moisture or direct sunlight.
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1.1 Unpacking instructions
1.
Confirm that the packing box is undamaged. If the box is damaged, contact the shipper.
2.
Open the top of the box and carefully unpack all components.
3.
Confirm that all components are undamaged. If any of the components is damaged,
contact the shipper.
4.
Confirm that all components are included. If any of the components is missing, contact
your GE Healthcare distributor.
1.2 Choosing location
Environmental requirements
• Install the patient monitor to a location that meets the specified environmental
requirements of operating temperature, humidity and atmospheric pressure.
•
Set up the device in a location which affords sufficient ventilation. The ventilation
openings of the device must not be obstructed.
EMI & RFI interference:
• The patient monitor should be isolated from sources of strong electromagnetic and radio
frequency interference.
NOTE: Refer to "ElectroMagnetic Compatibility" for more information.
1.3 Mounting the monitor
Mounting of monitor to the Wall Mount, Rollstand, Wall Mount with standard arm or Counter
Top Mount is described in a separate instruction sheet delivered with each mount.
NOTE: Refer to the “Supplier and accessories” to identify the compatible mounting hardware.
1.4 Connection to power
Testing the battery charge
Before installing a battery to the patient monitor, verify the battery’s state of charge. Press the
green TEST button on the battery. The number of charge level indicator LEDs that illuminate
indicates the approximate charge remaining in the battery.
−
Four LEDs illuminated: 75% – 100% of full-charge capacity.
−
Three LEDs illuminated: 50% – 74.9% of full-charge capacity.
−
Two LEDs illuminated: 25% – 49.9% of full-charge capacity.
−
One LED illuminated: 10% – 24.9% of full-charge capacity.
−
One LED flashing: < 10% of full-charge capacity remaining.
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Installation
Installing the batteries
1. Open the lid of the battery compartment by the 2. Put in the new battery. Make sure that the
side of the monitor. Move the latch up or down.
charging indicator is facing to the back side of
the monitor, then push the battery in all the
way, move the latch and close the lid. Power on
the monitor, check the monitor indicators.
Connecting to mains
Connect the power cord to the mains power inlet at the back of the monitor and to the wall
socket.
NOTE: Before taking the monitor into use for the first time, the batteries should be fully charged.
Keep the monitor connected to the mains until the Battery charging symbol disappears (may
take up to 5 hours if the batteries are fully discharged).
Battery charging symbol
WARNING
The power cord may only be connected to a three-wire, grounded, hospital
grade receptacle
1.5 Check configuration
Check the monitor’s license and record in B. Installation and checkout form, B40/B20. The later
set up and check out shall according to monitor’s configuration.
1.
Turn on the monitor, enter to the service menu: Monitor Setup > Install/Service
(16-4-34) > Service (26-23-8)
2.
Enter to license control menu: SW Management > License
3.
Record the product license.
4.
If the configuration is different with your order, contact GE Healthcare distributor.
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1.6 Connection to Network
WARNING
WARNING
CAUTION
Do not use with iCentral software V5.0.3 and earlier.
Do not use Mobile Care Server software V5.2 and earlier.
Install HL7 network interfaces as specified, and only by qualified personnel.
NOTE: Not all the features mentioned following is available you monitor, according to your
monitor’s configuration to set up.
The monitor has been verified to be able to work in CARESCAPETM Network and S/5 network
environments. Other network infrastructures are not supported.
The monitor has EMR connectivity. There are three ways to acquire trended vital sign data from
patient monitor: HL7 directly from monitor, HL7 from the CARESCAPE Gateway, or connecting
to the serial port of each monitor. The monitor HL7 (Health Level Seven) message match with
IHE PCD-01 OBR/OBX format.
•
In CARESCAPE network, the monitor can:
−
communicate with GE CARESCAPE Central Station V1
−
communicate with GE CARESCAPE pro CIC version 4.0.8, 4.1.1 and 5.1.0
−
compatible with Aware Gateway Server V1.6
−
compatible with CARESCAPE Gateway server V1
−
compatible with Mobile Care Server V6.0
−
compatible with S/5 Collect V4.0
The monitor can talk to at most 4 CIC Central stations/CARESCAPE Central Station, 1
Aware Gateway Server or 1 CARESCAPE Gateway Server, 1 Mobile Care Server and 1000
other devices simultaneously in one CARESCAPE network. The B40 monitor can’t be set as
the Time Master in CARESCAPE network.
•
In S/5 network, the monitor can:
−
communication with iCentral version 5.1.1 and 5.1.2.
−
compatible with S/5 Collect V4.0
−
compatible with Mobile Care Server later than V5.2
The monitor does not support Patient Data Server; B40 realtime patient data can't be viewed
on other monitors (e.g. Dash 3000/4000/5000, Solar 8000, B850, B650).
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Installation
CARESCAPE Network
CIS/HIS Systems
CARESCAPE Administrative VLAN Network
1
Hospital Intranet
1
Internet
CARESCAPE IX VLAN Network
CARESCAPE?
CIC Pro
CARESCAPE
Monitor B850
CARESCAPE
Monitor B650
Mobile
Care
Server
CARESCAPE MC VLAN Network
Layer 3 Switch
1
RX
Network
1
HL7 PCD-01
Outbound
HL7 PCD-01
Outbound
Dash®
Patient Monitor
1.
B40/B20
Patient Monitor
B40/B20
Patient Monitor
HL7 outbound from monitor though CNI V2 switch, need ‘Unity and HL7’ license
Hospital Network
CIS/HIS Systems
2
Hospital Intranet
2
Internet
Hospital Switch
HL7 PCD-01
Outbound
B40/B20
Patient Monitor
2.
HL7 outbound from monitor though hospital switch, need ‘HL7’ license
Notes
•
•
This switch should support intervlan routing function.
•
If hospital or the third party design networks by themselves, the hospital or the third party
has full responsibility for the function and the risk of their network.
The hospital or the third party can choose GE offered switch or other types. If you need to
use GE offered switch, please contact to GE ND&I Team to setup CARESCAPE Network
Infrastucture version 2.
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1.6.1 Pre-installation requirements
Ensure that the applicable network infrastructure is in place prior to the installation of the
patient monitor.
Acquire the network configuration information from the hospital IT or the related project
documentation and installation files.
MC Network
• The MC Network infrastructure shall be installed according to the "CARESCAPE Network
Configuration Guide".
•
The installation site of the patient monitor shall have a wall jack and a network patch
cable for the MC Network.
S/5 Network
• The S/5 Network shall be installed according to the "S/5 Network Installation Guide". Refer
to the "iCentral and iCentral Client Service Manual" for iCentral installation instructions.
•
The installation site of the patient monitor shall have a wall jack and a network patch
cable for the S/5 Network.
HL7 network
The HL7 Network shall be installed according to the "B40/B20 patient monitor HL7 reference
manual".
1.6.2 To connect the network
MC and S/5 network
Use the CAT-5 network cable to connect the monitor to the network.
1.
Make sure that the power is switched off.
2.
Connect the one RJ-45 connector to network port at the back of the monitor.
3.
Connect the other RJ-45 connector to the corresponding port on the wallbox.
4.
Turn on the monitor and set up the network configuraiton (refer to 1.6.3. Network
configuration).
5.
Confirm that the network symbol and 'Network made' message are displayed in the
upper part of the screen.
1.6.3 Network configuration
How to set up MC network
1.
Connect network cable to the ethernet port on the rear of the monitor. Connect the other
end of the cable to the clinical network.
2.
Enter the network service mode in the monitor:
Monitor Setup > Install/Service (16-4-34) > Service (26-23-8) > Frame > Network
3.
Set up Unity configuration, enter to Network Config
•
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Unit Name:
It is used for setting the unit name in the monitor. The default unit name is “X”.
NOTE: Unit Name here should be set to be same as CIC Unit Name.
Installation
4.
WARNING
•
Bed Name:
It is used for setting the bed name in the monitor. The default bed name is the last
five characters of the MAC address, excluding the colon delimiter characters.
•
MCS IP Address
It is used for setting Mobile Care Server’s IP address which the monitor will talk to.
It is gray when network license is not “Unity” or “Unity+HL7”.
•
Save Changes:
It is gray if the changes have not been done to the menu information.
NOTE: When save changes the monitor need restart.
Set up the TCP/IP configuration: TCP/IP Config > TCP/IP Config
•
Configure the monitor’s IP address, subnet mask, default gateway.
NOTE: If the IP address or both of unit name and bed name duplicate with other
CARESCAPE network devices, the alarm will be given to the new added monitors.
•
Save the configuration after configuring the TCP/IP.
NOTE: After saving changes the monitor need restart.
If only B40 monitors and Dash monitors in the Unity network, do not set up
B40 monitors with the highest IP address. For this may cause the Unity time
sync function can’t work with Dash monitors.
5.
If the monitor does not connect to network correctly, you may also need to set up the
speed and duplex configuration:
TCP/IP Config > TCP/IP Config > Speed and Duplex
Choose the suitable settings according to your network environment. The default setting
is AUTO.
How to set up S/5 network
1.
Connect network cable to the ethernet port on the rear of the monitor. Connect the other
end of the cable to the clinical network.
2.
Enter the network service mode in the monitor:
Monitor Setup > Install/Service (16-4-34) > Service (26-23-8) > Frame > Network
3.
Set up S/5 network configuration, enter to Dri config
Set up following information:
•
DRI level:
It is used for setting the monitor’s network communication. should be selected to
2009
•
Virtual Plug ID:
Should enter 5 digit numbers, which is the same as in iCentral.
NOTE: If you don’t have the virtual plug ID number in iCentral, please refer to the
“iCentral User's Reference Manual” to set up in iCentral first.
NOTE: After saving changes the monitor need restart.
•
Transfer Mode:
It is used for choosing transfer mode: DRI/ETH or DRI/UDP
Should be selected to DRI/ETH
•
Care Area:
It is used for setting care area “OR” or “Non OR” for monitor.
The monitor with different care area settings will behave differently in iCentral.
NOTE: After saving changes the monitor need restart.
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B40/B20 Patient Monitor
•
Save Changes:
Select “Save Changes“ to take in use changes made in this page.
NOTE: In S/5 network protocol, no need to set up the TCP/IP settings.
NOTE: For other the network menu’s instruction, please refer to 3.2. Network in “Service
Menu” chapter for more details.
How to set up the HL7
1.
Set up Unit name and bed name first:
Monitor Setup > Install/Service (16-4-34) > Service (26-23-8) > Frame > Network >
Network Config > Unit name and Bed Name.
2.
Enter the HL7 service mode in the monitor:
Monitor Setup > Install/Service (16-4-34) > Service (26-23-8) > Frame > Network > HL7.
3.
Set up HL7 configuration, enter to HL7 Config
Set up following information:
•
HL7 Receiver IP
Set up the HL7 receiver IP address
•
HL7 Receiver Port
Set up the HL7 receiver port
•
HL7 Interval
Set up the interval value
•
HL7 Patient Class
Set up HL7 patient class
E: Emergency, I: Inpatient, O: Outpatient, P: Preadmit, R: Reocurring patient, B:
Obstetrics, U: Unknown
•
Save Changes
It is gray if the changes have not been done to the menu information.
1.7 Inserting and removing the E modules
To use the E module, your monitor need pre-configure the extension rack from manufacture.
The E module options: airway gas module (E-miniC, E-sCO, E-sCAiO and N-CAiO), E-Entropy
module.
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Installation
To insert module:
1.
Align the module with the insertion guides
2.
Push the module into the monitor frame until it clicks and stops.
3.
Pull the module outwards to insure the module is firmly seated.
To remove module:
WARNING
1.8
1.
Pressing the release latch, on the bottom of the module.
2.
Grasp the module firmly and pull out of the Frame. Make sure not to drop it when it comes
out.
When detaching modules, be careful not to drop them. Always support with
one hand while pulling out with other.
Monitor connections
2
1
11
10
9
5
4
8
7
Figure 3
3
6
B40 Front view
(1)
Transportation handle
(2)
Alarm light
(3)
The Trim Knob
(4)
Keyboard/membrane switch
(5)
Battery compartment
(6)
Guide rail for GCX mounting
(7)
Mains power and battery LEDs
(8)
On/Off key
(9)
Hemo connectors
B20 Front view
(10) E modules
(11) Recorder module
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Figure 4
B40 back
B20 back
1
4
6
5
7
2
3
Figure 5
I/O and connectors
(1)
Receptacle for power cord
(2)
Serial port
(3)
Defibrillator connector
(4)
Nurse call connector
(5)
Network connector
(6)
Equipotential connector
(7)
Multi I/O connector
NOTE: The Multi I/O with ports 2,3,4 are optional parts for customer.
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Installation
1.9 Visual indicators
Function
Specification
Explanation
External power supply
Green LED
Indicates when monitor is powered from
mains
Battery operation
Green LED
Indicates when monitor is powered from
internal batteries
Battery condition
Orange LED
Indicates when monitor is charging
batteries (solid) or battery failure (flashing).
Alarm Light
Highly visible
Red/Yellow/Cyan
light
Ease alarm detection from distance.
1.10 Installation checkout
Refer to the 3. Installation checkout in Chapter 3 for procedure.
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3 Maintenance
Instructions
1
Instructions
1.1 Introduction
These instructions include procedures of system maintenance for the B40. It’s include four
sections:
•
•
Electrical safety tests.
•
•
Maintenance and checkout, which should be performed every 24 months.
Installation checkout, which should be performed after installation and service
configuration.
Adjustments and calibrations
NOTE: Please complete the check form when performing the corresponding procedures.
NOTE: For the Gas modules maintenance and calibration, please refer to “7. E-miniC Module”
and “8. E-sCO, E-sCAiO and N-CAiO Modules“.
NOTE: For the Entropy module maintenance and calibration, please refer to “9. E-Entropy
Module“.
The symbol

in the instructions means that the procedure performed should be signed in
the check form.
The procedures should be performed in ascending order, bypassing those that are not
applicable for a particular monitor.
To enter the service menus, you need following passwords:
Monitor Setup - Install/Service (password 16-4-34) - Service (password 26-23-8)
In case you evaluate the measurement accuracy with a patient simulator, add the simulator’s
accuracy specification to the one for the monitor.
CAUTION
CAUTION
CAUTION
Failure on the part of all responsible individuals, hospitals or institutions,
employing the use of this device, to implement the recommended
maintenance schedule may cause equipment failure. The manufacturer does
not, in any manner, assume the responsibility for performing the
recommended maintenance schedule, unless an equipment maintenance
agreement exists. The sole responsibility rests with the individuals, hospitals, or
institutions utilizing the device.
Only trained personnel with appropriate equipment should perform the tests
and repairs outlined in this section. Unauthorized service may void warranty of
the unit.
Wear a static control wrist strap when handling PCB boards. Electrostatic
discharge may damage components on the board.
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1.2 Recommended tools
NOTE: Use only properly maintained, calibrated and traceable measurement equipment for the
specified calibrations and adjustments to ensure accuracy.
NOTE: A functional tester cannot be used to assess the accuracy of pulse oximeter for monitor.
Table 1
Recommended accessories and tools
Accessories
A rigid cylinder or pipe
NIBP cuff
Adult NIBP cuff hose with cuff ID
Infant NIBP cuff hose with cuff ID
Tubing parts to connect a manometer and a pump to
the NIPB cuff and hose.
Dual invasive pressure adapter cable
ECG accessories, IEC or AHA
-
Multi-link 3-lead integrated cable and leadwire
-
Multi-link 5-leadwire set
-
Multi-link 3/5-lead ECG trunk cable
SpO2 finger probe
SpO2 Interconnect Cable
Temperature dual cable
CO2 Sampling line 3m/10 ft
Tool
A multiparameter patient simulator with IBP, Temp
adpter cables
Screwdrivers PH1, PH2
NOTE: For details on recommended accessories see “Supplies and Accessories“ catalog.
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Electrical Safety Tests
2
Electrical Safety Tests
Electrical safety tests provide a method of determining if potential electrical health hazards to
the patient or operator of the device exist.
GE recommends that the qualified personnel performing the tests.
2.1 Test setup
Test conditions
Perform electrical safety tests under normal ambient conditions of temperature, humidity and
pressure.
Test equipment
The recommended test equipment required to perform electrical safety tests is listed below.
Tool
Specification
Satety Analyzer/Leakage Current Tester
Equivalent to the circuits
shown
Ground Bond Tester
0 – 1 ohm
Safety Test Body Kita
P/N M1155870 or equivalent
a
Instead of the test bodies included in the safety test body kit, other applicable test
bodies with all pins connected together may be used.
Perform electrical safety tests using an electrical safety analyzer per IEC 60601-1, UL 60601-1,
EN 60601-1 or CSA C22.2 No. 601.1. The schematics in the section provide a general
understanding of the test equipment. Actual configuration of test equipment may vary.
The patient monitor being tested should be placed on an insulating surface.
NOTE: Before proceeding, make sure that all test equipment is properly calibrated, maintained
and functioning.
NOTE: Refer to the instructions delivered with the safety analyzer to perform each test.
NOTE: GE recommends that the qualified personnel performing the tests should record the test
results of each electrical safety test, for example by using the installation / maintenance check
forms included in this manual.
System setup
These instructions are intended for every component in the system. Ensure that all system
components are properly connected to the patient monitor as described in chapter “2.
Hardware installation”.
2.2 Power Outlet Test
Verify that the power outlet is wired correctly per the country’s electrical code standard before
starting the following electrical safety tests. The results of the following tests will be inaccurate
unless a properly wired power outlet is used. Use only non-isolated power outlets when
performing safety tests.

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2.3 Power cord and plug
Verify the power cord being used with the patient monitor is good. The following are a couple
of things to check for in this regard:
•
Inspect the power cord for wear or damage regularly. If damage is suspected, test for
continuity through each conductor of the power cord connector.
•
Verify line, neutral, and earth conductors are properly connected to the power cord plug
and are not short-circuited. Replace the power cord, as necessary with a
regulatory-approved cord for the country of use.

WARNING
Use only AC power cords recommended or manufactured by GE.
2.4 Ground (earth) integrity
Listed below are two methods for checking the ground (earth) integrity, “Ground Continuity
Test” and “Impedance of Protective Earth Connection.” These tests determine whether the
device's exposed metal and power inlet's earth (ground) connection has a power ground fault
condition.
Perform the in accordance with your local regulations.
Refer to the instructions contained with the safety analyzer to perform each test.
2.4.1 Ground Continuity Test
The measuring device (MD) in the diagram below may be a DMM or part of a safety analyzer.
NOTE: The measuring device (MD) represents the network and voltage measuring instrument
and its frequency characteristics per IEC 60601-1.

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Document no. 2081505-001
Electrical Safety Tests
Acceptance criteria:
•
For equipment without a power supply cord, the impedance between the protective earth
terminal and any accessible metal part which is protectively earthed shall not exceed 0.1
ohms.
•
For equipment with a power supply cord, the impedance between the protective earth
pin in the mains plug and any accessible metal part which is protectively earthed shall
not exceed 0.2 ohms.
2.4.2 Impedance of Protective Earth Connection
This test, unlike a ground continuity test, will also stress the ground system by using special
ground bond testers.
This test normally is only required as a manufacturing production test to receive safety agency
compliance. Some country agencies do require this test after field equipment repairs (i.e.,
Germany’s DIN VDE 0751 standards). Consult your country/local safety agency if in question.
Check compliance as follows:
(1)
A current of 25A from a current source with a frequency of 50 or 60 Hz with a no-load
voltage not exceeding 6 V is passed for at least 5 seconds, but no more than 10 seconds,
through the protective earth terminal or the protective earth pin in the mains plug and
each accessible metal part which could become live in case of failure in basic insulation.
(2)
The voltage drop between the parts described is measured and the impedance
determined from the current and voltage drop. It shall not exceed the values indicated.
When taking this measurement, move the unit’s power cord around. There should be no
fluctuations in resistance.

Acceptance criteria:
•
For equipment without a power supply cord, the impedance between the protective earth
terminal any accessible metal part which is protectively earthed shall not exceed 0.1
Ohms.
•
For equipment with a power supply cord, the impedance between the protective earth
pin in the mains plug and any accessible metal part which is protectively earthed shall
not exceed 0.2 ohms.
2.5 Earth leakage current test
This test measures the current leakage flowing from the mains part through or across the
insulation into the protective earth conductor of the device under test.
Perform this test both in Normal Condition (NC) and in a Single Fault Condition (SFC), where one
of the supply conductors is open at a time. Perform the test with normal and reverse polarity.
NOTE: Refer to the instructions delivered with the safety analyzer to perform this test.
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Power Cord
Leakage Tester
HIGH
NORM
Power Cord
LOW
GND
GND
RVS
Device
Under
Test
0.15µF
DMM
1K
10
DMM set to measure AC voltage
NOTE: The measuring device (MD) represents the network and voltage measuring instrument
and its frequency characteristics per IEC 60601-1.
(1)
Configure the safety analyzer as follows (NC):
•
•
Polarity - NORMAL
Neutral - CLOSED
(2)
Power on the device under test.
(3)
Read and record the current leakage indicated on the tester.
(4)
Configure the safety analyzer as follows (SFC):
•
•
Polarity - NORMAL
Neutral - OPEN
(5)
Read and record the current leakage indicated on the tester.
(6)
Configure the safety analyzer as follows (SFC):
•
•
Polarity - REVERSED
Neutral - OPEN
(7)
Read and record the current leakage indicated on the tester.
(8)
Configure the safety analyzer as follows (NC):
•
•
(9)
Polarity - REVERSED
Neutral - CLOSED
Read and record the current leakage indicated on the tester.
(10) Power off the device under test.

Acceptance criteria in NC (Normal condition):
•
All readings shall be less than or equal to 300 μA for installations that require compliance
to UL 60601-1 requirements.
•
All readings shall be less than or equal to 500 μA for installations that require compliance
to EN 60601-1 / IEC 60601-1 requirements.
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Electrical Safety Tests
Acceptance criteria in SFC (Single fault condition) - one of the supply conductors open at a time:
•
All readings shall be less than or equal to 1 mA.
2.6 Enclosure (Touch) leakage current test
This test measures current leakage through the exposed conductive parts on the device under
test.
Perform the test in Normal Condition (NC) and in two different Single Fault Conditions (SFC): 1)
earth open and 2) one of the supply conductors open at a time. Perform the test with normal
and reverse polarity.
NOTE: Refer to the instructions delivered with the safety analyzer to perform this test.
Power Cord
Leakage Tester
HIGH
NORM
Power Cord
LOW
GND
RVS
Open
Closed
GND
Device
Under
Test
0.15µF
DMM
1K
10
Probe to exposed conductive chassis
DMM set to measure AC voltage
NOTE: The MD represents the network and voltage measuring instrument and its frequency
characteristics per IEC 60601-1.
(1)
Configure the safety analyzer as follows (NC):
•
•
•
Polarity - NORMAL
Neutral - CLOSED
GND (Earth) - CLOSED
(2)
Power on device under test.
(3)
Read and record the current leakage indicated on tester.
(4)
Configure the safety analyzer as follows (SFC):
•
•
•
Polarity - NORMAL
Neutral - OPEN
GND (Earth) - CLOSED
(5)
Read and record the current leakage indicated on the tester.
(6)
Configure the safety analyzer as follows (SFC):
•
•
•
Polarity - NORMAL
Neutral - CLOSED
GND (Earth) - OPEN
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(7)
Read and record the current leakage indicated on the tester.
(8)
Configure the safety analyzer as follows (SFC):
•
•
•
(9)
Polarity - REVERSED
Neutral - CLOSED
GND (Earth) - OPEN
Read and record the current leakage indicated on the tester.
(10) Configure the safety analyzer as follows (SFC):
•
•
•
Polarity - REVERSED
Neutral - OPEN
GND (Earth) - CLOSED
(11) Read and record the current leakage indicated on the tester.
(12) Configure the safety analyzer as follows (NC):
•
•
•
Polarity - REVERSED
Neutral - CLOSED
GND (Earth) - CLOSED
(13) Read and record the current leakage indicated on the tester.
(14) Power off the device under test.

Acceptance criteria in NC:
•
All readings shall be less than or equal to 100 µA
Acceptance criteria in SFC - earth open or one of the supply conductors open at a time:
•
All readings shall be less than or equal to 300 μA for installations that require compliance
to UL 60601-1 requirements.
•
All readings shall be less than or equal to 500 μA for installations that require compliance
to EN 60601-1 / IEC 60601-1 requirements.
2.7 Patient leakage current tests - overview
The following table specifies the parameter modules and the related patient connectors to be
tested in the “2.7.1. Patient (source) leakage current test” and in the “2.7.2. Patient (sink) leakage
current tests”.
Use the safety test body kit, P/N M1155870 (or equivalent), to perform patient leakage current
tests. This safety test body kit contains various patient connectors where all pins are shorted
out together. For information on which test body to use for each patient connector, refer to the
service instructions included in the safety test body kit.
NOTE: If not otherwise stated in the table below, each test body is connected directly to the
specified connector in the patient module.
Table 2
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Patient connectors to be tested with each module
Electrical Safety Tests
Module
Patient connector
Hemo
ECG and SpO2
E-Entropy
1. Connect an Entropy sensor cable to the
module.
2. Connect the specified test body to the
Entropy sensor and cable.
2.7.1 Patient (source) leakage current test
This procedure measures the leakage current from an applied part connector of the device to
ground.
Perform the test in Normal Condition (NC) and in two different Single Fault Conditions (SFC): 1)
earth open and 2) one of the supply conductors open at a time. Perform test with normal and
reverse polarity.
NOTE: Refer to the instructions delivered with the safety analyzer to perform this test.
AC Mains
Leakage Tester
/,1(
NORM
Power Cord
1(875$/
($57+
RVS
Device
Under
Test
120K
Closed
GND
0.15μF
DMM
1K
Patient connector
Test Body
10
NOTE: The MD represents the network and voltage measuring instrument and its frequency
characteristics per IEC 60601-1.
NOTE: Perform this test for all the connected parameter modules and patient connectors
specified in Table 2.
(1)
Configure the safety analyzer as follows (NC):
•
•
•
Polarity - NORMAL
Neutral - CLOSED
GND (Earth) - CLOSED
(2)
Power on the device under test.
(3)
Read and record the current leakage indicated on the tester.
(4)
Configure the safety analyzer as follows (SFC):
•
•
•
Polarity - NORMAL
Neutral - OPEN
GND (Earth) - CLOSED
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(5)
Read and record the current leakage indicated on the tester.
(6)
Configure the safety analyzer as follows (SFC):
•
•
•
Polarity - NORMAL
Neutral - CLOSED
GND (Earth) - OPEN
(7)
Read and record the current leakage indicated on the tester.
(8)
Configure the safety analyzer as follows (SFC):
•
•
•
(9)
Polarity - REVERSED
Neutral - CLOSED
GND (Earth) - OPEN
Read and record the current leakage indicated on the tester.
(10) Configure the safety analyzer as follows (SFC):
•
•
•
Polarity - REVERSED
Neutral - OPEN
GND (Earth) - CLOSED
(11) Read and record the current leakage indicated on the tester.
(12) Configure the safety analyzer as follows (NC):
•
•
•
Polarity - REVERSED
Neutral - CLOSED
GND (Earth) - CLOSED
(13) Read and record the current leakage indicated on the tester.
(14) Power off the device under test.
(15) Repeat this test for all the connected parameter modules and patient connectors
specified in Table 2.

Acceptance criteria in NC:
•
All readings shall be less than or equal to 10 µA
Acceptance criteria in SFC - earth open or one of the supply conductors open at a time
•
All readings shall be less than or equal to 50 µA
2.7.2 Patient (sink) leakage current tests
This procedure measures the leakage current from an applied part connector of the device to
ground. Perform the test in Normal Condition (NC) with normal and reverse polarity.
NOTE: Refer to the instructions delivered with the safety analyzer to perform this test.
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Electrical Safety Tests
Power Cord
Leakage Tester
LINE
NORM
Power Cord
NEUTRAL
EARTH
RVS
Device
Under
Test
120K
Closed
GND
Patient connector
Test Body
0.15μF
DMM
1K
10
(Keep cable length as
short as possible.)
NOTE: The MD represents the network and voltage measuring instrument and its frequency
characteristics per IEC 60601-1.
NOTE: Per IEC 60601-1, the impedance to protect the circuitry and the person performing the
test, but low enough to accept currents higher than the allowable values of the LEAKAGE
CURRENT to be measured.
WARNING
Shock hazard. The following step causes high voltage at the test body. Do
not touch the test body.
NOTE: Perform this test for all the connected parameter modules and patient connectors
specified in Table 2.
(1)
Configure the safety analyzer as follows:
•
•
•
Polarity - NORMAL
Neutral - CLOSED
GND (Earth) - CLOSED
(2)
Power on the device under test.
(3)
Read and record the current leakage indicated on the tester.
(4)
Configure the safety analyzer as follows:
•
•
•
Polarity - REVERSED
Neutral - CLOSED
GND (Earth) - CLOSED
(5)
Read and record the current leakage indicated on the tester.
(6)
Power off the device under test.
(7)
Repeat this test for all the connected parameter modules and patient connectors
specified in Table 2.

Acceptance criteria:
•
All readings shall be less than or equal to 50 µA
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2.8 Test completion
(1)
Disconnect the safety analyzer from the power outlet.
(2)
Disconnect the test equipment from the patient monitor.
(3)
Disconnect the patient monitor’s power cord from the leakage tester.
(4)
Fill in all necessary documents.
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Installation checkout
3
Installation checkout
The purpose of the installation checkout procedure is to ensure that the system is properly
installed and configured for use.
Service personnel shall perform the following checkout procedure for the monitoring system
after the hardware installation and service configuration is completed:
1.
3.1. Visual inspection
2.
3.2. Functional inspection
Skip the tests that are not applicable for the installed monitor.
These instructions include a "Installation and checkout form, B40/B20" on page B-1 to be filled
in when performing the procedures.
3.1 Visual inspection
Perform the following visual inspection to the installed monitoring system:
•
•
•
Carefully inspect the patient monitor for any damage.
•
•
Verify that the modules are properly connected and locked in place.
Verify that the patient monitor is properly mounted with specified mounting solutions.
Verify that the cables between the patient monitor and the connected peripheral devices
are intact and properly connected to the right connectors.
Verify that the battery door is properly locked.
The cleaning precautions, cleaning requirements, cleaning procedures, and recommended
cleaning solutions for the monitor are described in the "User’s Guide". For details about
cleaning, disinfecting and sterilizing the accessories, see the instructions for use in the
accessory package.
3.2 Functional inspection
3.2.1 Start-up
1.
Turn on the patient monitor.
Verify that the monitor starts up normally:
•
•
•
The red, yellow and cyan alarm lights are lit in sequence.
•
Check and there are no error messages on the screen.
The speaker gives an audible beep.
Check that the GE logo screen is displayed, followed by the notes screen and the
normal monitoring screen appears.
NOTE: Refer to section "Condition the battery" to see the procedure for battery conditioning if
you receive a a Condition Battery X message.
NOTE: Before taking the patient monitor into use for the first time, the battery should be fully
charged. Keep the monitor connected to the mains until the battery is fully charged.

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3.2.2 Display
1.
Verify that all text is readable and all images are clear.
2.
Verify that the brightness is good. Adjust if necessary.

3.2.3 Time and date
1.
Check that the clock on the screen shows correct time. Adjust the time and date, if
necessary.
Monitor Setup < Time and Date
NOTE: The monitor can’t be set as the TIME MASTER in network. You should adjust the
time and date from the central station.

3.2.4 Parameters measurements
Connect the accessories (no need to connect simulator/patient), check the monitor displays the
following messages or activities.
•
•
ECG: After connecting ECG cable, ‘leads off’ will display in the Waveform Field
•
•
SpO2: After connecting SpO2 cable and sensor, SpO2 sensor will be lit.
NIBP: After connecting NIBP hose to module, ‘Adult/Pediatric’ or ‘Neonatal’ will display in
NIBP Digital Field for several seconds
Temperature: After connecting Temp cable and sensor, ‘Performing temp test:’ will display
in Temp Digital Field for several seconds.
•
IBP: After connecting IBP cable and transducer, ‘InvBP’s not Zeroed’ will display in
Message Field.
•
Gas: After installing the gas module, ‘Calibrating gas sensor’ will display in CO2 waveform
field for about 1 minutes.
•
Entropy: After installing the E-Entropy module and cable, 'No sensor' message will display
in Entropy digital field.

3.2.5 Recorder
1.
Press the Recorder Start/Stop key and check that the module starts recording the
selected waveforms. Press the Recorder Start/Stop key again to stop recording.
2.
Check that the quality of the recordings is acceptable.

3.2.6 MC or S/5 Network connection
NOTE: Pre-configure the network when install the monitor.
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Document no. 2081505-001
Installation checkout
1.
Check that the CAT-5 cable connector is clean and intact, then connect it to the Network
connector on the backside of the monitor.
Check that the monitor connects to the network, i.e. the network symbol appears on the
upper right-hand corner of the screen.

3.2.7 Conclusion
•
•
•
Power off the monitor
Perform final cleaning
Fill in all necessary documents, refer to "Installation and checkout form, B40/B20" on
page B-1

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B40/B20 Patient Monitor
4
Maintenance and checkout
These instructions include procedures for maintenance and checkout for the B40.
Service personnel shall perform the following checkout procedure every 24 months
after installation:
1.
4.1. Visual inspection
2.
2. Electrical Safety Tests
3.
4.2. Functional inspection
4.
4.3. Monitor battery maintenance
Skip the tests that are not applicable for the installed monitor.
These instructions include "Maintenance and checkout form, B40/B20" on page C-1, which to
be filled in when performing the corresponding procedures.
Before starting
• Save the patient data and monitor settings if necessary.
• Make sure that the monitor is turned off.
• Disconnect the mains power cord.
• If the monitor is connected to the network, disconnect the CAT-5 cable from the monitor.
4.1 Visual inspection
Perform the following visual inspection to the installed monitoring system:
•
•
•
Carefully inspect the patient monitor for any damage.
•
•
Verify that the modules are properly connected and locked in place.
Verify that the patient monitor is properly mounted with specified mounting solutions.
Verify that the cables between the patient monitor and the connected peripheral devices
are intact and properly connected to the right connectors.
Verify that the battery door is properly locked.
The cleaning precautions, cleaning requirements, cleaning procedures, and recommended
cleaning solutions for the monitor are described in the "User’s Guide". For details about
cleaning, disinfecting and sterilizing the accessories, see the instructions for use in the
accessory package.

4.2 Functional inspection
4.2.1 Start-up
1.
Turn on the patient monitor.
Verify that the monitor starts up normally:
•
•
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Document no. 2081505-001
The red, yellow and cyan alarm lights are lit in sequence.
The speaker gives an audible beep.
Maintenance and checkout
•
Check that the GE logo screen is displayed, followed by the notes screen and the
normal monitoring screen appears.
•
Check and there are no error messages on the screen.
NOTE: Refer to section "Condition the battery" on page 3-23 to see the procedure for battery
conditioning if you receive a a Condition Battery X message.
NOTE: Batteries are recommended to be conditioned every six months.

4.2.2 Display
1.
Verify that all text is readable and all images are clear.
2.
Verify that the brightness is good. Adjust if necessary.

4.2.3 Keyboard(s)
1.
Tests with the keyboard/membrane switch:
−
Enter the service menu:
Monitor Setup < Install/Service (16-4-34) < Service (password 26-23-8) Keyboard
−
Check the keys one by one, turn trim knob one full turn clockwise and one full turn
counter clockwise.

4.2.4 Time and date
1.
Check that the clock on the screen shows correct time. Adjust the time and date, if
necessary.
Monitor Setup < Time and Date
NOTE: The monitor can’t be set as the TIME MASTER in network. You should adjust the
time and date from the central station.

4.2.5 Hemo Module
ECG measurement
• Configure ECG settings in monitor:
Connect 5 lead ECG cable to monitor and simulator.
Monitor Setup < Screen Setup < Waveform Fields < Field 1: ECG1; Field 2: ECG2;
Field 3: ECG3
ECG < ECG1 Lead: II; ECG2 Lead: V1; ECG3 Lead: aVL; ECG Size: 1.0
< ECG Setup < Beat Sound Volume: 1 or greater; Pacemaker: Show; HR Source: AUTO
•
Configure ECG settings in simulator:
ECG rhythm: a normal sinus rhythm
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B40/B20 Patient Monitor
heart rate: 80 bpm
Amplitude: 1 mV
1.
Normal Sinus Rhythm
−
Check that the monitor displays the ECG leads II, V1 & aVL and the waveforms are
noise-free. The monitor shall display a 80 ± 5 bpm heart rate and an audible QRS
tone sounds with each QRS complex.

2.
Pacemaker Detection
−
Configure the simulator to output "Asynchronous Pacemaker Pulse"
−
Check that pacemaker spikes are shown on the ECG waveform.

3.
Asystole Detection
−
Configure the simulator to output "Asystole".
−
Check that the 'Asystole' alarm appears to the monitor screen.
−
Configure the simulator to show "80 beats per minute, Normal Sinus Rhythm".

4.
Leads Off Detection
−
Detach the RA/R leadwire from the simulator.
−
Check that the Lead II waveform disappears from the ECG1 waveform field and a
message 'RA/R lead off'' is shown momentarily.
−
Check that Lead II is replaced by Lead III in the ECG1 waveform field after a while
and a message 'Lead changed' is followed by a message 'Learning'.
−
Reconnect the RA/R leadwire to the simulator.
−
Check that Lead III is replaced back to Lead II in the ECG waveform field.

Respiration measurement
• Configure RESP settings in monitor:
Set up the Resp waveform field to the monitor screen:
Monitor Setup < Screen Setup < Waveform Fields < Field 4: Resp
And
Others < RespSetup < Resp Rate Source: Imped.
< Measurement: ON
•
Configure RESP settings in simulator:
Baseline impedance: 1000
Amplitude: 1
Respiration rate: 20 breaths per minute
Lead selection: II (or LL)
5.
Respiration Rate
−
Check that the RESP waveform is shown and the RR value is 20 (±5).
−
Configure the simulator's Apnea Simulation to "32 sec".
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Maintenance and checkout

6.
Apnea Detection
−
Check that the monitor activates the Apnea alarm.
−
Configure the simulator's Apnea Simulation to "OFF"

Temperature measurement
• Configure the “T1+T2” digit field to the monitor screen.
• Configure the simulator’s temperature channels as follows:
Temperature : 37 °C/98.6 °F
7.
Temperature detection
−
Check the corresponding temperature value appears and that no error messages
are shown on the monitor screen.
NOTE: If the deviation on a temperature reading on the screen is more than 0.1°C,
calibrate the temperature channels according to the instructions in chapter
"Temperature calibration" on page 3-25.

Invasive blood pressure measurement
• Configure the simulator’s IBP channels as follows:
Sensitivity: 5 µV/V/mmHg
InvBP outputs: "0 mmHg static pressure" or "atmosphere"
8.
Zeroing
−
Press IBP Zero All key.
−
Check that a message "Zeroing" followed by a message "Zeroed" is shown in the IBP
parameter window.

9.
Static Pressure
−
Configure the simulator's InvBP output to "200 mmHg static pressure".
−
Check that the flat pressure line appears on the related waveform field. The reading
in the parameter window shall be 200 ±10 mmHg.
NOTE: Recalibration is required, if the measured value is not within the specification.
Calibrate the invasive pressure channels according to the instructions in "Invasive
pressure calibration" on page 3-26.

10.
Pressure Waveforms
−
Configure the simulator's InvBP output to "Arterial 120/80".
−
Check that the pressure waveform for tested invasive pressure channel appears in
the IBP waveform field and the Sys/Dia (Mean) pressure values are shown in the
related parameter window.
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B40/B20 Patient Monitor

SpO2 measurement
11.
Test measurement
Connect the SpO2 probe onto your finger. Check that the reading of 90-100 and SpO2
waveform appears. Check that the HR value is calculated from SpO2 when ECG and IBP
(ABP or Art) are not measured.
NOTE: a functional tester cannot be used to assess the accuracy of a pulse oximeter probe or a
pulse oximeter monitor

Non Invasive Blood Pressure measurement
• Connect and set up the NIBP integrated tool as following picture, ensure all the
connections made are leak-proof.
12.
NIBP Leak Test
−
Enter the NIBP Calibration in service menu:
Parameters < NIBP < Calibrations
−
Select Active Leak Test: ON
−
Wait for 15 seconds for the pressure to stabilize then check that the pressure does
not drop more than 5 mmHg per one minute.

13.
NIBP calibration
−
Calibrate the Non-invasive blood pressure (NIBP) channel according to the
instructions in "NIBP calibrations" on page 3-24.

14.
NIBP hose detection
−
3-20
Document no. 2081505-001
Disconnect the calibration test equipment.
Maintenance and checkout
−
Make sure NIBP Setup - Inflation Limits is set to Auto.
−
Attach an A/P NIBP cuff hose without cuff identification.
−
Press the NIBP Start/Cancel key. After a few moments the monitor automatically
opens the selections NIBP Setup - Inflation Limits for user to manually select the
inflation limits.

4.2.6 Loudspeaker
Check the loudspeaker by setting the alarm volume:
Alarms Setup < Alarm Volume
Test the whole volume scale from 1 to 10 by turning the Trim Knob and check that the
alarm volume changes correspondingly. The alarm sound should be clear and audible
with all the settings.

4.2.7 Monitor software
Enter the service menu:
Monitor Setup < Install Service (16-4-34) < Service (26-23-8)
Take down the information regarding Monitor software.

4.2.8 Watchdog circuitry
Select:
Monitor Setup < Install Service (16-4-34) < Service (26-23-8) < Set/Test
Perform the tests Watchdog and WD by Overload. Check that the monitor restarts in
each case.
NOTE: When selecting Watchdog and WD by Overload, auto restarting should take place
approximately after 10 seconds.

4.2.9 Network
NOTE: Pre-configure the network when install the monitor.
1.
Check that the CAT-5 cable connector is clean and intact, then connect it to the Network
connector on the backside of the monitor.
Check that the monitor connects to the network, i.e. the network symbol appears on the
upper right-hand corner of the screen.

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4.2.10 Final cleaning
Switch off the monitor and perform final cleaning.
Fill in all necessary documents, refer to "Maintenance and checkout form, B40/B20" on
page C-1.

4.3 Monitor battery maintenance
The lithium-ion (Li-Ion) battery is a rechargeable battery containing lithium-ion cells. Each
battery contains an integrated electronic fuel gauge and a safety protection circuit.
The following are facts about lithium-ion battery technology:
•
The battery discharges on its own, even when it is not installed in the equipment. This
discharge is the result of the lithium-ion cells and the bias current required for the
integrated electronics.
•
•
The capacity loss of the battery degrades significantly at higher temperatures.
As the battery ages, the full-charge capacity of the battery degrades and is permanently
lost. As a result, the amount of charge that is stored and available for use is reduced.
4.3.1 Use recommendations
GE recommends the following methods to improve battery performance:
−
Location — Position the equipment in a location that does not artificially increase the
operating temperature of the batteries.
−
Conditioning guideline — Condition the battery when a ‘Condition Battery X’ message is
shown on the monitor screen. The condition cycle recalibrates the electronic fuel gauge.
4.3.2 Storage recommendations
GE recommends storing the battery outside of the device at a temperature between 20°C to
25°C (68°F to 77°F).
4.3.3 Test the battery charge
Before installing a battery, verify the battery’s state of charge. Press the green TEST button on
the battery. The number of charge level indicator LEDs that illuminate indicates the
approximate charge remaining in the battery.
−
Four LEDs illuminated: 75% – 100% of full-charge capacity.
−
Three LEDs illuminated: 50% – 74.9% of full-charge capacity.
−
Two LEDs illuminated: 25% – 49.9% of full-charge capacity.
−
One LED illuminated: 10% – 24.9% of full-charge capacity.
−
One LED flashing: < 10% of full-charge capacity remaining.
4.3.4 Charge the battery
The battery charges whenever it is installed into the patient monitor and the patient monitor is
connected to an AC power source.
The battery is charging both when the patient monitor is turned on and turn off. Battery is
charging as long as the orange battery charging indicator LED is lit.
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Maintenance and checkout
4.3.5 Condition the battery
Battery conditioning is needed if the ‘Condition Battery X’ message is displayed.
Condition the battery by fully discharging and recharging the battery twice according to the
following procedure:
NOTE: The patient monitor must be in a discharged state during battery conditioning.
Disconnect any acquisition modules from the patient monitor if connected.
1.
Turn on the patient monitor. Disconnect the power cord from the wall outlet. Leave the
patient monitor on until the battery is fully discharged and the patient monitor turns off
automatically.
NOTE: Ignore the ‘Battery Low’ and ‘Battery Empty’ messages when discharging the battery.
2.
Reconnect the power cord to the wall outlet and turn on the patient monitor. Leave the
patient monitor on until the battery is fully recharged and the orange battery charging
indicator LED turns off.
3.
Repeat the steps 1 and 2 once.
The battery is now conditioned and ready for use. However if the ‘Condition Battery X’
message is still shown on the screen, replace the battery.
4.3.6 Replace the battery
Replace the battery in the following situations:
−
If the ‘Replace Battery X’ message is displayed. This message indicates that the
full-charge capacity of the used battery has considerably degraded compared to the
design capacity of a new battery.
Remove the battery from the monitor and install a new battery according to the procedure in
section "Installing the batteries" on page 2-3.
NOTE: Dispose of the battery according to local, state or country laws.
WARNING
Do not incinerate the battery or store at high temperatures.
NOTE: Refer to section "Battery indicators" on page 4-6 for more detailed information about the
battery status.
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5
Adjustments and calibrations
NOTE: Use only properly maintained, calibrated and traceable measurement equipment for the
specified calibrations and adjustments to ensure accuracy.
NOTE: Discharge the patient before do the following procedures.
5.1 NIBP calibrations
NIBP calibration should be performed:
•
•
•
Each time planned maintenance is performed.
Each time corrective maintenance is performed.
If the measured value is not within the specification.
Calibration check
• Refer to the "Non Invasive Blood Pressure measurement" on page 3-20 in maintenance
checkout section for NIBP integrated tool set up.
1.
Enter Calibration menu:
Monitor Setup - Install/Service (password 16-4-34) -Service (26-23-8) - Parameters NIBP - Calibrations
Calibration
Active Leak Test
OFF
Calibration Check OFF
Protection
OFF
Calibrate
Previous Menu
2.
Select Calibration Check and push the Trim Knob.
3.
Connect an external precision manometer to the monitor, the same as "Non Invasive
Blood Pressure measurement" on page 3-20.
4.
Pump the following pressures to manometer and check the difference between the
manometer and monitor pressure display (The zeroing offset is automatically subtracted
from the pressure readings).
Table 3
NIBP calibration check pressures
Pressure
Max. error
Example
0 mmHg
±5 mmHg (=zero offset)
-1
100 mmHg
100 ±2 mmHg
100 ±2
200 mmHg
200 ±3 mmHg
200 ±3
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Document no. 2081505-001
Adjustments and calibrations
There is a reading of B1 and B2 in help filed under NIBP calibration menu. If the error of
pressure channel B1 and B2 is larger than specified above, the module should be recalibrated.
The error of B2 has no effect on blood pressure measurement accuracy.
NOTE: If the monitor pass the calibration check, no need to do NIBP calibration.
Calibration
1.
Enter Calibration menu.
2.
Disconnect the hoses from the NIBP connector to enable proper zeroing.
3.
Select Calibrate. If it is not available, perform the steps a and b.
a.
b.
Select Protection OFF in the Calibration menu and push the Trim Knob.
Menu selection Calibrate is now enabled.
•
Start calibration by pushing the Trim Knob. Messages ‘Zeroing’ and ‘Zeroed’ will be
displayed in the NIBP message field.
•
Connect an external manometer with a pump to the module through the both tubes of
the hose - both transducers B1 and B2 will be calibrated simultaneously. Pump up to a
pressure of about 200 mmHg according to the manometer. Calibration is possible in the
range of 150 to 250 mmHg.
•
Verify that both pressure values in the prompt field match the manometer reading. If not,
adjust by turning the Trim Knob. When the values of the pressure bar and the manometer
are equal, push the Trim Knob to confirm the calibration. The message ‘Calibrating’ and
‘Calibrated’ will be displayed on the NIBP digit field after a few seconds.
•
To set the protection on:
Select Protection ON and push the Trim Knob.
NOTE: If a long time not choose ON manually, this menu will automatically return to
Protection ON.
5.2 Temperature calibration
Temperature calibration should be performed:
•
•
If the temperature test values differ for more than 0.1 °C.
1.
Connect the TEMP accessories to the monitor, use P/N 884515-HEL Temperature
calibration plugs
2.
Enter STP Module service menu.
After STP/TP board replacement.
Monitor Setup - Install/Service (password 16-4-34) - Service (password 26-23-8) Parameters - STP.
3.
Enter Calibrations menu.
4.
Choose Protection OFF in protect mode.
5.
Select Calibrate T1/Calibrate T2.
6.
Insert calibration plug (25 °C) into T1/T2 connector.
7.
Push the Trim Knob.
8.
Insert calibration plug (45 °C) into T1/T2 connector.
9.
Push the Trim Knob.
•
Check Protection ON in protect mode.
NOTE: If a long time not choose ON manually, this menu will automatically return to
Protection ON.
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5.3 Invasive pressure calibration
IBP calibration should be performed:
•
•
•
When the pressure transducer (probe) is replaced with a different type of transducer.
When the measured value is not in the acceptable specification.
After STP board replacement.
NOTE: Before starting invasive pressure calibration, disconnect all patient cables and discharge
the patient.
There are two methods to complete the calibration as following:
Using a transducer
1.
Connect the IBP accessories to the monitor, use a pressure manometer with a pressure
pump
2.
Enter STP service menu.
Monitor Setup - Install/Service (password 16-4-34) - Service (password 26-23-8) Parameters - STP.
3.
Enter Calibrations menu.
4.
Choose Protection OFF in protect mode.
5.
Connect a pressure transducer with a pressure manometer to the P1/P2 connector.
Choose Calibrate P1 or Calibrate P2. Leave the transducer to room air pressure.
6.
Push the Trim Knob to start zeroing.
7.
Supply a pressure of 100 mmHg to 300 mmHg to the transducer. The recommended
pressure is 200 mmHg.
8.
Set the pressure on the display to match the pressure reading on the manometer and
push the Trim Knob. A tolerance of ±1 mmHg is allowed.
9.
The message ‘Calibrated’ will be displayed on the display.
•
Check Protection ON in protect mode.
NOTE: If a long time not choose ON manually, this menu will automatically return to
Protection ON.
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Document no. 2081505-001
Adjustments and calibrations
Using a simulator
1.
Connect the IBP accessories to the monitor and simulator.
2.
Enter STP service menu.
Monitor Setup - Install/Service (password 16-4-34) - Service (password 26-23-8) Parameters - STP.
3.
Enter Calibrations menu.
4.
Choose Protection OFF in protect mode.
5.
Choose Calibrate P1 or Calibrate P2. Set the P1 or P2 channel to 0 mmHg on the
simulator.
6.
Push the Trim Knob to start zeroing.
7.
Set a pressure of 100 mmHg to 300 mmHg on the simulator. The recommended pressure
is 200 mmHg.
8.
Set the pressure on the display to match the pressure reading on the simulator and push
the Trim Knob. A tolerance of ±1 mmHg is allowed.
9.
The message ‘Calibrated’ will be displayed on the display.
10.
Check Protection ON in protect mode.
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Document no. 2081505-001
4 Troubleshooting
Introduction
1
Introduction
The problems and solutions in this section represent only a few of the faults that you may
encounter and are not intended to cover every possible problem that may occur.
This chapter focuses on troubleshooting technical problems. For clinical and operation issues
refer to the "User’s Guide" for troubleshooting.
NOTE: For the Gas modules troubleshooting, please refer to “8. E-sCO, E-sCAiO and N-CAiO
Modules“.
NOTE: For the Entropy module troubleshooting, please refer to “9. E-Entropy Module“.
If the problem remains, call technical support for service. To ensure accurate problem solving,
please be prepared to provide the following information:
•
•
•
•
Problem description and the troubleshooting done so far.
Device information.
Error messages displayed, if any.
Other information, as requested.
1.1 Visual inspection
Before beginning any detailed troubleshooting, complete a thorough visual inspection to be
sure that:
•
•
•
There is no physical damage.
The patient monitor is properly powered.
No incompatible parts or devices used. Refer to “Supplies and accessories” for list of
compatible devices.
If loose parts or cable connections inside the monitor are suspected, disassemble the patient
monitor to a level needed to perform an internal visual check. Check that:
•
•
•
all screws are tightened properly
all cables are connected properly
there are no loose objects inside the monitor
NOTE: Perform the electrical safety test and the checkout procedure every time you have
disassembled the patient monitor.
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B40/B20 Patient Monitor
1.2 General troubleshooting
Disconnect the mains power cord and
remove the batteries.
No picture on screen
Check the batteries charging
levels by pressing the test
buttons on the batteries.
Connect the mains
power cord
Front panel green
mains power LED lit?
Replace fuses
No
Power board SW
functioning
Yes
Insert only one battery with 2 or
more capacity leds illuminating.
Press the ON/OFF key.
Front panel green
battery LED lit?
Yes
Yes
Disconnect the mains
power cord and batteries.
Reconnect and press the
ON/OFF key.
No
No
Mains power
LED lit?
Possible AC/DC unit
failure. Replace the
AC/DC unit.
Power board failure
Yes
Mains power
LED lit?
Yes
Wait for about 1 minute
and press the NIBP auto
ON/OFF key, NOTE: NIBP
cuff must be connected
NIBP pump starts
pumping and connected
SpO2 probe, Is SpO2
probe red LED lit?
Possible key board or CPU
failure. See Frame
troubleshooting in this chapter.
Display failure. See Frame
troubleshooting in this
chapter.
Yes
No
Normal start-up sound
and the alarm LEDs turn
on and off?
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Document no. 2081505-001
No
No
Main CPU board may be
faulty.
Introduction
1.3 Software troubleshooting chart
Yes
Start-up with GE
logo image?
Check the software CD whether
can run in the PC normally and
try to download the SW again.
Turn off the monitor.
Download the software from
software CD onto the CPU
board.
NOTE: Refer to Software
download instruction in CD.
No
OK?
No
Turn the power on.
Wait for 120
seconds.
No
OK?
Yes
No
Yes
Start-up display
appears?
No
Try with another
software CD to
download again. Please
read the note below.
Replace the CPU
board and try again.
Yes
Yes
Has the information
regarding monitor software
been updated on the
Service View?
Perform factory reset.
NOTE:
The software CD may be
defective.
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B40/B20 Patient Monitor
2
Frame troubleshooting
Problem
Cause
What to do
Monitor is not starting.
1. The batteries are empty.
2. Fuses may be blown.
3. If power cord connected, AC/DC
unit may be faulty.
4. If AC/DC unit is working, the
power board may be faulty.
5. On/Stby key may be faulty.
1. Connect the power cord.
2. Replace fuses.
3. Replace the AC/DC power unit.
1. The connection between power
board and CPU board may be
faulty.
2. Faulty CPU board.
1. Check connection between power
board and CPU board.
1. The display cables are loose.
1. Check the display connection
board connectors.
2. Check inverter cable.
Backlight Inverter may be faulty.
Replace the Inverter board.
Monitor is not starting.
The monitor starts (alarm beep
is heard), but the display
remains black.
2. The backlights are not lit.
4. Replace the power board unit.
5. Replace the keyboard/membrane
switch panel or the
interconnection cable.
2. Replace the CPU board.
Display and monitor operating 1. Loudspeaker connector or wires
but no audible beep in start-up.
loose or faulty.
1. Check loudspeaker connector and
wires.
Display is too dim.
1. Incorrect brightness adjustment.
2. Backlight faulty.
3. Backlight inverter faulty.
1. Adjust display brightness higher.
2. Check inverter cable.
3. Replace backlight.
Stripes or white areas on screen. 1. Loose faulty display connection
cable in CPU and display.
1. Check display connection cable in
CPU and display.
Module data disappears from
the screen. ‘Module power
supply overload’ message.
Parameter module current (in
module bus) too high.
Detach and change parameter
module.
Module data disappears.
1. Module bus voltage or signals
path broken.
1. Replace module interface board.
2. Replace the cable between
module interface board and
Power board.
3. Change the parameter module.
‘Replace Battery’ message on
the screen.
1. Problem in communication
between battery and power
board.
2. Battery too old or defected.
3. power board may be faulty.
4. Problem in communication
between power board and CPU
1. Replace battery.
'Frame temperature high'
message.
The temperature inside the frame is
too high.
Check monitor ventilation holes.
‘Battery temperature high’
message on the screen.
Battery SMBus temperature is too
high.
Check monitor ventilation holes.
Replace battery.
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2. Replace battery.
3. Replace the power board.
Frame troubleshooting
Problem
Cause
What to do
Keyboard not working, but
module communication is OK.
Keyboard cables and connectors
may be faulty.
1. Check the keyboard/membrane
switch connection to the user
interface board.
2. Check the interconnection cable
between user interface board and
battery board.
Keyboard not working, and
module communication not
working.
UPI section of the CPU board not
functioning normally.
Restart the monitor.
Keyboard partly not working.
1. Check the interconnection cable
1. Keyboard/membrane switch
between user interface board and
faulty.
battery board.
2. Keyboard cables and connectors
2. Check the keyboard/membrane
may be faulty.
switch connection to the user
interface board.
3. Replace the keyboard/membrane
switch.
Replace the CPU Board.
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B40/B20 Patient Monitor
2.1 Battery indicators
The messages, screen symbols and the LED indicators tell the user about the status of the
batteries.
The Green main LED will indicate that monitor is powered by Main. The Green battery LED will
indicate that monitor is powered by battery. The Orange battery LED lit will indicate that the
battery is in charging. The Orange battery LED flashing will indicate that the battery is defect. If
the battery is fully charged and it’s main powered. the orange and Green battery LED will both
dark.
Table 4
Battery indicators
Screen symbol
A
B
Explanation
Front panel battery LED
indicators
Monitor is battery
powered. Batteries are
fully charged and the
size of the green bar
indicates the charging
level.
Orange dark
Green lit
B
Monitor is battery
powered. Battery A is
empty, battery B is ok.
Orange dark
Green lit
B
Monitor is battery
powered. Battery A
failure, battery B is ok.
Orange flashing
Green lit
B
B
A
NOTE: If both batteries fail, the green battery LED is dark.
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Monitor is mains
powered. Battery A is
being charged (white
bar), battery B is already
charged.
Orange lit
Green dark
No battery backup.
Monitor is mains
powered.
Orange dark
Green dark
Frame troubleshooting
2.2 NET section troubleshooting
Problem
Cause
Monitor does not connect to Patch panel
the network.
Patch cable
Monitor connects to the
network, but disconnects
unexpectedly (‘Network
down: central station’
message on the monitor
screen).
What to do
Patch cable not connected to HUB or to panel.
Patch cable or connector defective.
HUB not connected to power supply.
HUB port closed due to physical layer problems.
HUB port temporarily closed and reopened due
to physical layer problems.
HUBs not properly connected to each other.
Monitor-Network cable
Cable not properly connected to the wallplate
or to the monitor.
Cable or connector defective.
Network cable (inside the
monitor) defective
Replace the Network cable - in FRU
2053489-004.
External interface board
defective
Replace the External interface board - in FRU
2053489-004.
Net section of the CPU board
The NET section is defective. Replace the CPU
board.
NET section memory on the
CPU board
The SDRAM of the NET section is defective or
uninitialized. The NET cannot be used. See
network service page for details.
‘Check network connectors’ Monitor-Network cable
message shows on the
monitor screen
Network printing fails
Cable not properly connected to the wallplate
or to the monitor.
Cable or connector defective.
Network cable (inside the
monitor) defective
Replace the Network cable - in FRU
2053489-004.
External interface board
defective
Replace the External interface board - in FRU
2053489-004.
Didn’t properly set up “virtual
plug id“
Set up the virtual plug id in monitor.
Print server is busy
Network manager's print server is busy at the
moment and cannot take more print jobs. Try
again after 15 seconds.
Print queue is full
There are too many unprinted documents
waiting in the print queue. Check the printer, as
it is not operating properly.
Printer is off-line
Printer cable is loose, printer is out of paper,
there is a paper jam or the printer is simply
switched to off-line state.
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Problem
Cause
What to do
No vitial signs data send to
EMR system
No HL7 license
Check about the HL7 license
HL7 configuration error
• Check HL7 configuration for vitial signs
receiver IP and port.
• Check HL7 Status view menu
The vitial sign receiver system Check the Service Log, if have “AR” or “AE”
have error or reject to receive. message from vitial sign receiver system, this is
the receiver system’s issue.
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Document no. 2081505-001
Hemo Troubleshooting
3
Hemo Troubleshooting
3.1 NIBP troubleshooting flowchart
NIBP module not
working
Insert Hemo
module to a good
monitor
Yes
Yes
Replace the flex
module bus
No
Is it OK?
Check the module interface
board; the cable between
module interface board and
power board in the frame
Remove the cover of
Hemo module (connect the
module to monitor, then
power on)
No
Green LED on
NIBP board lit?
Replace NIBP
board
NIBP
parameter display
on the screen?
No
Yes
Yes
Start NIBP
without hose
Cuff loose
message appears
on screen?
No
Check if NIBP
connector spring
contact well with
the button of cuff
ID board
Yes
ENd
NIBP
function well?
Leak test in
Service Menu
OK?
No
Check tubes
connectors and
manifold
Pump check
in Service Menu
OK?
No
Check pump
connector.
No
See error code
explanation in
service manual
and fix it
No
NOTE: Please refer to 5.4. NIBP Module in Chapter 5 for Service Menu instruction.
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3.2 ECG troubleshooting flowchart
ECG module not
working
No
Refer to NIBP
flowcharts
No
Replace the flex
module cable. Or
remove STP board
(STP board may faulty)
No
End
Yes
Does NIBP
module work
well?
Replace ECG
board
Yes
ECG parameter
display on screen?
No
ECG function
well?
Check ECG input
connector, ECG input
board and ECG input
flex cable
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Document no. 2081505-001
Hemo Troubleshooting
3.3 STP troubleshooting flowchart
STP module not
working
No
Refer to NIBP
flowcharts
No
Select the right
configuration
No
Replace the flex module
cable. Or remove ECG
board from the flex
module cable.
No
Check STP input
board, STP/TP input
flex cable.
No
Check STP input board,
STP/TP input flex cable.
Check Masimo/Nellcor
SpO2 board connect on the
TP board well.
Yes
Does NIBP
module work
well?
Go to service
menu
Yes
Is STP parameter
configuration
correct?
Replace STP/TP
board
Yes
STP/TP parameter
display on screen?
Yes
Temp/IBP
function well?
Yes
SpO2 function
well?
End
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B40/B20 Patient Monitor
3.4 NIBP
3.4.1 NIBP toubleshooting
Problem
Cause
What to do
No NIBP value displayed
NIBP not selected on screen.
Check monitor setup.
‘Weak pulsation’ message
Weak or unstable oscillation pulses
due to:
Check patient condition and retry.
• artifacts
• weak pulse pressure due to
Use proper size of cuff. Check
attachment.
Check any leaks and retry.
arrhythmias
• improper cuff position or
attachment
• too few pulses detected
• weak or unusual blood
circulation
• obese patient
Call service
‘Error X’ message
NIBP hardware error.
X = error number.
See 3.4.2. NIBP error code explanation
for the description of the error message
code.
‘Cuff loose’ message
1. Hose and/or cuff not connected. 1. Connect the hose and the cuff.
2. Hose and cuff connected.
Reasons:
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Document no. 2081505-001
-
cuff loosely wrapped
-
Tighten the cuff.
-
leakage inside the shield, in the
Patient connector panel or
tubings connecting to the
module
-
Check the tubings inside the shield
and Patient connector panel, fix if
necessary.
-
leakage in cuff or hose
-
Replace cuff/hose.
-
leakage inside module
-
Check internal tubing and fix if
necessary.
-
pump does not work
-
Check pump connector; if OK,
replace the NIBP Pump Unit.
Hemo Troubleshooting
Problem
Cause
What to do
Air leakage
1. Hose or cuff leaking. Reasons:
1. Replace cuff
-
cuff damaged
-
Replace cuff.
-
cuff connector damaged
-
Replace cuff connector (if the fault is
in hose connector).
-
O-ring damaged or missing
-
Replace O-ring.
-
hose double connector damaged -
2. Hose and cuff OK. Reasons:
‘Cuff occlusion’ message
Replace NIBP cuff hose.
2. Connect or replace tube
-
leakage in the tubes connecting the patient connector panel and
the module
Check the tubes.
-
leakage inside the module
-
Replace the whole tubing.
-
tube disconnected or damaged
-
Fix connections.
-
manifold leaking
-
Replace the manifold.
-
tubes or valve(s) damaged
-
Replace tubes/valve(s).
1. Cuff and/or hose occluded.
Reason:
-
cuff tube kinked
-
Straighten tube.
-
tubes inside the shield kinked
-
Straighten tubes.
-
tubes inside module kinked
-
Straighten tubes.
-
occlusion inside/outside module
-
Remove occlusion.
2. Cuff, hose, and tubes OK.
Reason:
-
fault in pressure transducer
-
Replace the NIBP board.
-
fault in A/D converter
-
Replace the NIBP board.
-
faulty calibration
-
Check calibration.
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3.4.2 NIBP error code explanation
Code
Problem
What to do
0
RAM test failure
Change the NIBP board.
1
ROM checksum failure
Change the NIBP board.
2
Pump on during idle or over current detected
Check short circuits. Change the NIBP board.
3
Startup communication failure with safety CPU
Change the NIBP board.
4
EEPROM protection is off
Protect calibration by selecting Protection ON in
the NIBP calibration menu.
5
EEPROM read/write error
Change the NIBP board.
6
Valve stuck closed during cuff typing
Try to remeasure. If the problem persists,
recalibrate. If the problem still persists, change
the NIPB board.
7
Could not save calibration data
Reset the module and recalibrate. If this does not
help, change the NIBP board.
8
PT2 higher than 150 for greater than 15 seconds Check short circuits. Change the NIBP board.
while idle
9
Determination time too long
Automatic recovery.
10
RTK 400Hz timer re-entry
Change the NIBP board.
11
RTK 50Hz timer re-entry
Change the NIBP board.
12
Not in use
Not in use.
13
RTK overrun
Change the NIBP board.
14
Too early AUTO START according to module
check
Reset the monitor.
15
Calibration data invalid on initialization or unit
never calibrated
Recalibrate. If this does not help, change the
NIBP board.
16
Communication timeout between main and
safety CPU
Check short circuits. Change the NIBP board.
17
Safety CPU report communication timeout
Check short circuits. Change the NIBP board.
18
Wrong message rate in communication between Check short circuits. Change the NIBP board.
main and safety CPU ><+2% (480 msg/s)
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Hemo Troubleshooting
3.5 ECG
Problem
Cause
What to do
HR numerical display
shows ‘---’
No heart rate available.
If no ECG waveform, check LEADS OFF
message and connect the leads.
If ECG waveform exists, check heart rate
source e.g. in the ECG Setup menu behind
ECG key.
Unacceptable ECG
waveform
No ECG trace
Noise-message
Poor electrode or poor electrode skin
contact.
Electrodes from different manufacturers
are used. /Too much/little gel is used.
Poor electrode condition.
Electrodes are dried out.
Improper site of electrodes.
Check that electrodes are not placed over
bones, active muscles, or layers of fat.
Improper skin preparation.
Remove body hair. Clean attachment site
carefully with alcohol.
Improper bandwidth filter.
Check filter.
Dirty ECG cable.
Clean the cable.
Faulty ECG cable
Change the cable.
Waveform not selected on screen.
Press the Monitor Setup key and make
adjustments.
Module not plugged in correctly.
Check the hemo module’s installation.
High frequency or 50/60 Hz noise.
Isolate noise source.
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3.6 Impedance respiration
Problem
Cause
What to do
No resp trace
Waveform not selected on the screen
Press the Monitor Setup key and
make adjustments.
Module not plugged in correctly
Check the hemo module’s installation.
Poor electrode or poor electrode skin
contact
Electrodes from different
manufacturers are used. Too
much/little gel is used.
Poor electrode condition
Electrodes are dried out.
Improper site of electrodes
Check that electrodes are not placed
over bones, active muscles, or layers of
fat.
Improper skin preparation
Remove body hair. Clean attachment
site carefully with alcohol.
Faulty/ dirty ECG cable.
Change new cable.
Respiration source is CO2
Check respiration source and change it
to correct one.
Unacceptable resp
waveform
APNEA message, and
respiration waveform
normal
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Hemo Troubleshooting
3.7 Pulse oximetry (SpO2)
Problem
Cause
What to do
Message ‘NO PROBE’
No sensor connected to the module
SpO2 connector.
Check sensor connections.
Sensor faulty.
Change the sensor.
The type of sensor incorrect.
Change the sensor.
Flat cable connecting the SpO2
connector to the STP board loosen or
broken.
Check the Flat cable, replace if
necessary.
Unsuitable site.
Try another site.
Sensor faulty.
Try another sensor.
Sensor connection cable not
connected to sensor.
Connect the cable to sensor.
Sensor is slippery.
Wipe with 70% isopropyl alcohol and
allow drying.
Finger is too thin or thick.
Try other fingers, or other sensor types.
Poor perfusion.
Try another place.
Message ‘PROBE OFF’
though sensor properly
attached to the patient
Finger sensor falls off
Weak signal artifacts
Movement artifacts.
Shivering.
Message ‘CHECK PROBE’
Singal quality is too low to perform
SpO2 measurements.
Check probe condition or try another
sensor.
The type of sensor incorrect.
Change the sensor.
The monitor’s configuration for SpO2 is Check the monitor’s configuration.
not correct.
Message ‘FAULTY PROBE’
Sensor is faulty.
Change the sensor.
The type of sensor incorrect.
Change the sensor.
The monitor’s configuration for SpO2 is Check the monitor’s configuration.
not correct.
No SpO2
No waveform selected on screen.
Check the selected SpO2 waveforms by
pressing Monitor Setup key and
selecting Screen Setup - Waveform
Fields.
Wrong configuration setting.
Check the configuration settings from
the STP/Calibrations menu (Monitor
Setup - Install/Service - Service Parameters)
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3.8 Temperature
Problem
Cause
What to do
No temperature displayed
Wrong type of probe.
Use correct probe.
Temperature out of measurable range. The range is between 10 and 45 °C.
Temperature calibration not protected. Set the protection ON in the Service
Menu.
The monitor not configure TEMP.
Check the monitor’s configuration.
3.9 Invasive blood pressure
Problem
Cause
What to do
Abnormally low pressure
Transducer wrongly positioned.
Check mid-heart level and reposition
transducer.
No pressure
Defective transducer.
Check transducer.
‘Not zeroed’ message
No pressure module plugged in.
Check the module.
No waveform selected on screen.
Check the selected pressure
waveforms by pressing Monitor
Setup key and selecting Screen Setup
- Waveform Fields.
Check that the pressure transducer is
open to the patient.
Wrong configuration setting
Check the configuration setting from
the STP/Calibrations menu (Monitor
Setup - Install/Service - Service Parameters).
Measurement on, channel not zeroed.
Zero the channel.
Invasive pressure
calibration is not selectable
Patient case is active
Discharge a patient and make sure
that the hemo module does not receive
any signals from a simulator.
Out of range < - 40 mmHg
Measurement pressure is beyond the
measurement range.
Check the transducer level. Zero the
channel.
Out of range > 320 mmHg
Measurement pressure is beyond the
measurement range.
Check the transducer level. Zero the
channel. The patient may also have
high pressure.
Out of range
Measured pressure is beyond the
internal measurement range of the
module.
The waveform hits the top and the
numeric display not shown. Check the
transducer and its level. Zero the
channel.
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Document no. 2081505-001
5 Service Menu
Introduction
1
Introduction
The monitor has a Service Menu, which is a useful tool to examine monitor functions and
troubleshoot in case a fault occurs.
1.1 Service Menu structure
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1.2 Service Menu
NOTE: The Service Menu pictures are for reference only. Details on the menu page can vary
depending on the software version and the module type in use. If a particular selection is not
available in your system, the selection is shown grayed.
1. Press the Monitor Setup key.
2. Select Install/Service (password 16-4-34).
3. Select Service (password 26-23-8).
Service Menu
Sw version / Unit id
SW Management
Main Software
--------------------------------LX/VSP_0.06
BootStrap software
--------------------------B40_BOOTSTRAP_0.6
UBoot softeware
-------------------------------B40_UBOOT_0.8
Linux kernel
----------------------------------B40_OS_0.9
File system ----------------------------------------B40_FS_0.6
UMBC software --------------------------------------B40_UMBC_0.6
CPU serial number: -----------------------------92114469
CPU test date: -- code: --- level: --2008-09-02 M1008748 06
PMC version
--------------------------------------
Frame
keyboard
Parameters
Set / Test
Service Log
Scroll Vers
Record Vers
Clear Password
Previous Menu
Scroll Vers
Press Scroll Vers to scroll and view the detail version for monitor and modules on the extension
window.
Record Vers
Press Record Vers to record the detail version for monitor and modules on the extension
window.
Clear Password
The monitor will remember the service menu’s password you first enter. If you not restart the
monitor, the next time you enter to service menu, any random password can get the access.
Press Clear Password to clear the memory of password for service menu. When you next time
enter to service menu, can use other level password for different service menu’s access.
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SW Management
2
SW Management
The SW Management menu includes Software-specific service menus.
Service Menu
Sw version / Unit id
SW Management
----------------------------
SW Download
----------------------------
Active Inactive SW
Module SW Upgrade
----------------------------
Country Settings
----------------------------
License
-------------------------------------------------------
Previous Menu
---------------------------number:----------------200
----------------------------
2.1 SW Download
The SW Download submenu show IP Address and enable software download.
IP Address: Show the IP Address of the monitor.
Enable SW Download: Select YES can enable to
download main software.
SW Download
IP Address 172.16.1.23
Enable SW Download
Previous Menu
Selecting this enables
Software download
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2.2 Active Inactive SW
The Active Inactive SW submenu allows you to active inactive software.
Activation: Selection of activation can restart
the monitor and change the main software from
active software to incative software.
NOTE: If there is no inactive software in the
monitor, the selection is grayed.
Activation
Activation
Previous Menu
Soft Active Status
Active SW
B20/B40 Software: 0.19-0.6
Inactive SW
B20/B40 Software: empty
2.3 Module SW Upgrade
This submenu is used for module’s firmware upgrade.
Current Version: to show the related parameter firmware
current version.
Upgrade Version: to show the related parameter firmware
upgrade version.
SW Upgrade: after you download the new file system file, use
this menu to activate the new version of the related parameter
firmware software.
Upgrade SW Type: Select the parameter for firmware upgrade,
the options are: NIBP, ECG, RECX.
Module SW Upgrade
Current Version
B40_NIBP_1.04
Upgrade Version
NA
SW Upgrade
Upgrade SW Type
NIBP
Previous Menu
Return to previous menu.
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SW Management
2.4 Country Settings
The Country Settings submenu can be refered to 3.1. Country Settings.
2.5 License
The license submenu is used to set up monitor configuration for features.
Please contact GE representative to order the upgrade kits, which include the related
activation code for functions.
Serial number: Show serial number for this monitor, this item
can’t be selected.
Product type: Show product type for this monitor: B40, B40i, B20,
B20i.
You can input the activation code to enable the following
function:
GESP: GE SpO2
NELL: Nellcor SpO2
MASI: Masimo SpO2
INVP: IBP
TEMP: Temperature
OCRG: OCRG
NRES: Neonatal Respiration
UNTY: Unity network
NTS5: S5 network
NHL7: HL7 network
UTHL: Unity + HL7 network
NONE: None network
NOTE: When you finish to input the activation code, please
manually perform a cold start, then all the settings will be
activated.
NOTE: If disable the IBP or TEMP function, the IBP and TEMP
related settings in each mode will turn OFF, include the following
settings:
-
Waveform Fields
-
Digit Fields
-
Graphical Trends pages
-
Snapshot fields
-
Record Waveforms
The IBP and TEMP settings for Record Trends will change to Pleth.
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2.6 Enter/Exit Demo Mode
The submenu allows you to enter/exit the demo mode.
Under Demo Mode, the monitor displays the main vital signs values and waveforms. No need
accessories, central station or any other peripheral equipment connect to the monitor while in
Demo Mode.
NOTE: After select this menu, the monitor will restart automatically. A “memory error” message
will appear first time, please mannually restart the monitor again.
NOTE: All the values and waveforms the Monitor displays are fictional.
NOTE: The Demo Mode is only designed for the use of training and demo of operation. It is not
intended for clinical use or patient monitoring and diagnosis.
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Frame
3
Frame
The Frame menu includes frame-specific service menus.
Service Menu
Frame
Sw version / Unit id
----------------------------
Country Settings
Network
----------------------------
Power Supply
----------------------------
Previous Menu
------------------------------------------------------------------------------------------------------------number:----------------200
----------------------------
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3.1 Country Settings
Languages submenu: See following 3.1.1.
Languages
National Reqs: Select software features that
include national requirements.
Power Frequency: Set the power frequency (50/60
Hz). This setting is used to filter out possible power
frequency interference from parameter
measurements.
Time Format: Set the time format of the real-time
clock (12 h or 24 h).
Country Settings
Languages
National Reqs
None
Power Frequency
60Hz
Time Format
24 h
Previous Menu
Load laguages and change
current language.
3.1.1 Languages
Language
Select a language to be used during monitoring.
NOTE: Service pages will always appear in English despite
of this selection.
NOTE: For language codes, see the table below.
Country Settings
Languages
Language
ENG.LNG
Delete Language
Delete Language
ENG.LNG
Delete a language file from the permanent memory of the
monitor.
Previous Menu
POR.LNG
Cancel
Change language translation of
screen texts from currently
available language files.
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Frame
Table 4
Language abbreviations in language file names
Abbreviation
Language
CHI
Chinese
CZE
Czech
DAN
Danish
ENG
English
FRE
French
GER
German
HUN
Hungarian
ITA
Italian
NLB
Dutch
NOR
Norwegian
POL
Polish
POR
Portuguese
RUS
Russian
SPA
Spanish
SWE
Swedish
TUR
Turkish
FIN
Finnish
POB
Portuguese (Brazil)
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3.2 Network
Different network configuration (S/5 or MC) will have different menus.
MC
Network
Network Config
TCP/I P
HL7
Previous Menu
Network Status
Unity:
S5:
HL7:
Licensed
Non-Licensed
Non-Licensed
Unit Name:
Bed Name:
RtClin Marking:
NRtClin Marking:
NRtNClin Marking:
X
D0107
26
8
0
Interfaces:
Ethernet
WLAN
Not Connected
Not Connected
Current Interface:
Eth_B40
Connection:
Unity Network
Free message bu ffers
Current: 42
Minimum: 41
S/5
Network
Dri Config
Dri Comm
TCP/IP
Previous Menu
Network Status
Unity:
S5:
HL7:
Non-Licensed
Licensed
Non-Licensed
Virtual Plug Id:
Transfer Mode:
DRI Level:
DRI/ETH
2009
Interfaces:
Ethernet
WLAN
Not Connected
Not Connected
Current Interface:
Eth_B40
Connection:
Protocol stack restarted
Normal: 0
Error: 0
Free message buffers
Current: 256 Minimum: 255
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Frame
3.2.1 Network Config (MC)
Unit Name: It is used for setting the unit name in the monitor.
The default unit name is “X”. 7 characters at most.
Bed Name: It is used for setting the bed name in the monitor.
The default bed name is the last five characters of the MAC
address, excluding the colon delimiter characters. 5
characters at most.
RtClin Marking: It is used for tagging the following outgoing
packets with a DSCP marking of 26 (011010): realtime clinical
information (waveforms, parameters, alarms), Realtime
network control information (time)
NRtClin Marking: It is used for tagging the following outgoing
packets with a DSCP marking of 8 (001000): non-realtime
clinical decision support information (Admission, Histories, Full
Disclosure, Printing)
NRtNClinMark: It is used for tagging the following outgoing
packets with a DSCP marking of 0 (000000): non-realtime,
non-clinical decision support information (Service, InSite)
MCS IP Address: It is used for setting the MCS’s IP address, It’s
grey when network is HL7.
Save Changes: It is gray if the changes have not been done to
the menu information.
NOTE: When save changes the monitor will require a restart
except MCS IP address changed.
3.2.2 TCP/IP
TCP/IP Status
The TCP/IP Status view shows the general status of the TCP/IP set up.
Data link: “NIC” for ehternet,
DHCP Status: “Disabled“ or “Enabled“ depending
on the DHCP status.
The DHCP status related information displayed
below.
TCP/IP
TCP/IP Confing
Ping
Previous Menu
TCP/IP Status (Ethernet)
Data Link:
IP Address
Subnet Mask
Gateway IP
DNS Server
DHCP Server
SLP
NIC
172.16.1.54
255.255.0.0
172.16.254.254
Not available
Not available
Not available
DHCP Status:
Disabled
Current State
INIT REBOOT
Execution State
INIT REBOOT
Lease Time
0:00:00
Time Left
0.00.00
Logins
0
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TCP/IP config
IP address: For setting the static IP address of monitor.
Subnet Mask: For setting the static subnet mask of
monitor.
Default Gateway: For setting the static default gateway
of monitor.
Speed and Duplex: For setting speed and dupliex of
monitor.
Save Changes: Close menu and save the current menu
information to permanent memory.
Cancel Changes: Close menu without saving changes
Ping
IP Address: For configuring the destination IP address for the ping command.
Ping: Enable the ping command by sending Internet Control Message Protocol (ICMP) echo
request packets to the target host and wait for an ICMP response. The response should be
show in the Ping Status view.
3.2.3 HL7
The HL7 setup information is on HL7 Status view.
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HL7 config
HL7 Receiver Ip: For setting HL7 receiver IP address.
HL7 Receiver Port: For setting HL7 receiver port.
HL7 Interval For setting HL7 interval value.
HL7
HL7 Config
HL7 Patient Class: For setting HL7 patient class.
E : Emergency
I : Inpatient
O : Outpatient
HL7 Receiver Ip
HL7 Receiver Port
6000
HL7 Interval
1 min
P : Preadmit
HL7 Patient Class
E
R : Reocurring Patient
Acknowledgment
Enable
B : Obstetrics
Save Changes
U : Unknown
Previous Menu
Acknowledgment: Enable/Disable acknowledgment
check to HL7 server.
Save Changes: Close menu and save the current menu
information to permanent memory.
Set HL7 Receiver Ip
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3.2.4 Dri Config (S/5)
The DRI Level: For setting the monitor's network
communication. The network communication needs
match to the iCentral’s configuration. It should be selected
to 2009.
Network
Dri Config
Virtual Plug ID: For setting the same plug ID as in
iCentral’s.
Transfer Mode: For choosing the transfer mode: DRI/ETH
or DRI/UDP
Care Area: For setting the care area “OR” or “Non OR” for
monitor.
Debug server IP: For R&D purpose only.
Dri Level
2009
Virtual Plug ID
7978
Transfer Mode
DRI/ETH
Care Area
Non OR
Debug Server IP
Save Changes: Select "Save Changes" to take in use
changes made in this page.
Save Changes
Previous Menu
Push to select DRI Level.
3.2.5 Dri Comm (in S/5)
Session layer
Select Socket 1, 2, 3, 4 to view the status accordingly.
Dest. name shows the name of the Central
the monitor is connected to.
Dest. id shows the Central Subnet.
Dest. address shows the MAC address of
the monitor network NIC in Central.
Session layer
Socket 1
Socket 2
Socket 3
Protocol specific situations:
For R&D purpose only.
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Document no. 2081505-001
Socket 4
Previous Menu
Session Socket 1 Status
Dest. name
Dest. id
Dest. address
CENTRALMSF
Central Subnet 1
0a:1a:00:00:03:bb
Protocol special situations:
Tx resent critical
Rx non-critical duplicate
Rx critical duplicate
Rx non-critical with wrong msg num
Watchdog traffic disconnect
Missing ack disconnect
Protocol errors
0
0
0
1
0
0
1
Frame
Ethernet
The Ethernet Status view shows the general status of the ethernet network communication.
Driver: Ethernet chip name.
Cable: Indicates if the ethernet cable is
connected.
EthernetAddr: Monitor’s ethernet address.
Ethernet
Previous Menu
Speed: Indicates the current ethernet
communication speed.
Statistics In/Packets: Total number of
received packets since last cold start.
Statistics Out/Packets: Total number of
transmitted packets since last cold start.
Statistics In/Bytes: Total number of
received bytes since last cold start.
Statistics Out/Bytes: Total number of
transmitted bytes since last cold start.
The errors in Status view see following
table.
Table 1
Ethernet Status
Driver
Cable
Ethernet Addt
Speed (bits/s)
DP83907
Connected
00:40:97:0b:01:fb
0
Statistics
Packets
Bytes
In
2527
297776
Out
11327
9837268
Data errors
CRC
Frame
0
0
Transm.
0
BER
0
Hardware errors
Intern.
Missed
0
0
FIFO
0
Overrun
0
Ethernet errors
Value
Usage
CRC errors (CRC)
Number of received packets with
incorrect checksum.
Frame errors (Frame)
Number of received packets with
incorrect frame structure.
Transmission errors (Transm.)
Number or errors in packet
Transmission.
Notes
Refers to physical layer
problems. An erroneous packet
has often both frame and CRC
errors.
BER errors (BER)
Internal errors (Intern.)
Internal error of the network board.
Must always be 0.
Missed packets (Missed)
Number of received packets lost due to
overload.
Must always be 0.
FIFO errors (FIFO)
Internal error of the network board.
Must always be 0.
Overrun errors (Overrun)
Practically the same as above.
Must always be 0.
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3.3 Power supply
3.3.1 Power page
The menu shows the voltages and temperature measured by the power board and CPU board.
The values in the column under Mean are the mean values of last one second, the Min column
shows the minimum mean value, and the Max column the maximum mean value of the
voltages and temperature measured during the current power ON.
The voltages and currents are measured by the power Board, except the four lowest under
heading CPU Board A/D, which are measured by the CPU Board. +5V and +3.3V values come
thus both from the power Board and CPU Board. System power and Module power are
calculated by the power Board.
Voltages
ACDC AC/DC converter’s output voltage, used as
Min
Mean
Max
Power Supply Voltages
monitor input voltage when the mains cord is
14.90
ACDC
14.90
14.90
connected. Range when present: 15.25…16.55V
0.00
EXTDC
0.00
0.00
Power page
(Note: this includes the measurement inaccuracy).
12.00
Bat1
12.00
12.08
WPM Battery
12.24
Bat2
12.24
12.24
EXTDC Not used.
14.92
VSvs
14.92
14.92
Previous Menu
Bat1 Battery A voltage measured at power Board.
0.00
VBoost
0.00
0.00
Range 9…12.6V for Li-ION battery
14.98
VMod
14.98
14.98
0.00
Bat2 Battery B voltage measured at power
1/0 Mod
0.00
0.00
5.04
+5V
5.04
5.04
Board. Range 9…12.6V for Li-ION battery
3.35
+3.3V
3.36
3.37
VSys System voltage at power board. This is the
Currents
Mod Current
monitor input voltage measured at the power
0.31
0.39
0.33
Sys Current
0.87
1.34
1.23
board after input voltage selection. Range
Bat Current
0.00
0.00
0.00
9…16.5V.
Powers
VBoost Not used.
12.58
13.87
13.38
System Power
4.35
4.40
4.84
Module Power
VMod Supply voltage for modules. VBOOST is fed
Temp
C
through a circuit breaker to VMOD. Range
Power
38.77
38.77
38.77
13.8…16V.
Therm Not CHG
0.00
0.00
0.00
Dummy CHG
I/O Mod Not used.
0.00
0.00
0.00
CPU Board A/D
+5V At power board. Range 4.8...5.3V.
CPU temp ( C )
0.00
0.00
0.00
+3.3V At power board. Range 3.15…3.45V.
VSvs Out V
0.00
0.00
0.00
+3.3V
Currents
0.00
0.00
0.00
+5V
0.00
0.00
0.00
Mod Current Current from module bus voltage
VMOD. Depends on the module configuration.
Sys Current Current from system voltage VSYS. Depends on the system configuration and battery charging.
Bat current Current from or to the battery selected (discharge or charge). Measured at power Board. Depends on
the system configuration and battery charging.
Powers
System Power Power from VSYS, calculated by power Board software. System power = VSYS * SYS Current
Module Power Power from VMOD, calculated by power Board software. Module power = VMOD * Mod Current
Temp
Power1, Power2 Power supply unit temperature, measured at power Board.
Therm Not CHG Not used.
Dummy CHG Not used.
CPU Board A/D
CPU Temp Not used.
VSYS_OUT Not used.
+3.3VMeasured at CPU Board. Range 3.15…3.45V.
+5V Measured at CPU Board. Range 4.75…5.25V.
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Frame
3.3.2 WPM Battery
Batts
This page contains information related to the batteries and power supplies. The power supply
part is practically the same as in Power Page. Battery information includes also data measured
by the smart batteries themselves and transmitted to the power Board via SMBus.
SMBus is System Management Bus, a two-wire interface closely resembling IIC. SMBus is used
for battery communication.
Batts information section of the page has two columns: Batt1 for battery A data and Batt2 for
battery B data.
NOTE: Text ‘SMBus’ above Current (SMBus mA) line shows which battery is connected to the
SMBus.
Battery information
Dev. Chem.
Full Cap.(mAh)
Device chemistry. The
monitor supports only
Li-ION batteries.
Full charge capacity of
the battery; capacity
of the battery when it
is fully charged.
Rem. Cap. (mAh)
Remaining battery
capacity.
Rel. St. of CHG (%)
Relative state of
charge of the battery.
Expressed as a
percentage of Rem.
Cap. (mAh) / Full
Cap.(mAh).
Current (SMBus mA)
WPM Battery
Batts
Smart Batt1
Smart Batt2
Clear Temp Maxs
Previous Menu
Battery current
(discharge or charge)
measured by the
battery, transmitted
via SMBus to power
Board.
Batts Information
Dev . Chem.
Full Cap. (mAh)
Rem.Cap. (mAh)
Rel .St. of CHG (%)
Crrent (SMBUS mA)
Voltage (V)
Voltage (SMBUS mV)
ICHG Low
Batt Temp ( C )
Max Batt Temp (PMC)
Max Batt Temp (SMBUS)
Temps ( C )
Min
Power
45. 11
CPU
0. 00
Voltages (V)
ACDC
15. 00
ExtDC
0. 00
VSys
15. 00
Boost
0. 00
VMod
14. 53
I/O-VMod
0. 00
Currents (A)
0. 00
Batt
0. 30
Module
1. 65
Sys
Powers (W)
12. 38
Sys
4. 68
Module
Batt1
LION
0
0
0
SMBUS
0
11. 61
0
Batt2
LION
3345
3345
100
0
11. 69
12128
0. 00
32. 60
0. 00
Mean
45. 90
0. 00
31. 90
32. 20
32. 00
Max
45. 90
0. 00
15. 00
0. 00
15. 00
0. 00
14. 59
0. 00
15. 00
0. 00
15. 08
0. 00
14. 69
0. 00
0. 00
0. 32
1. 16
0. 00
0. 32
1. 16
13. 52
4. 79
13. 52
4. 84
Voltage (V)
Battery voltage measured at the power Board
Voltage (SMBus mV)
Battery voltage measured by the battery.
ICHG
Charging power level for charger hardware, this bit can have values high or
low. High is the normal setting, low is used when the power Board software
determines to limit the total power consumption of the monitor by limiting the
charging power (i.e. due to high temperature).
Batt Temp (°C)
Battery temperature. This is real time data for the battery connected to
SMBus.
Max Batt Temp (PMC) This is subject to change.
Max Batt Temp (SMBUS)Maximum battery SMBus temperature from entering the service pages. Max
values are updated in real time for the battery connected to the SMBus.
Other measurements See explanation in the previous power pages.
5-17
Document no. 2081505-001
B40/B20 Patient Monitor
Smart Batt1
Battx information from SMBus (this information
is received from the battery via SMBus)
WPM Battery
Temperature: Battery temperature
Batts
Voltage: Battery voltage
Smart Batt1
Current: Battery current (discharge or charge)
Smart Batt2
Avg. Current: Rolling average of the battery
current
Clear Temp Maxs
Previous Menu
Rel. State of Charge: Relative state of charge of
the battery. Expressed as a percentage of Rem.
Cap. (mAh) / Full Cap.(mAh).
Abs. State of Charge: Absolute state of charge.
Expressed as a percentage of Rem. Cap. (mAh)/
Design Capacity (mAh).
Batt1 information from SMBus
Temperature
Voltage
Current
Avg. Current
Rel. State of Charge
Abs. State of Charge
Remaining Capacity
Full Charge Capacity
Cvcle Count
Design Capacity
Design Voltage
30.75 C
11903 mV
0 mA
0 mA
97 %
72 %
2532 mAh
2604 mAh
33
3520 mAh
11100 mV
Manufacture Date(DD:MM:YY)
20/12/24
Manufacture Name
Device Name
Device Chemistry
Therm. Status from charger
NPC A07A90
SM201-6
LION
Remaining Capacity: Remaining battery capacity
(mAh).
Full Charge Capacity: Capacity of the battery
when it is fully charged.
Cycle Count: Number of cycles the battery has
experienced. A cycle is an amount of discharge approximately equal to the value of Design Capacity.
The exact value of cycle count threshold is stored in the battery permanent memory.
Design Capacity: Theoretical capacity of a new battery.
Design Voltage: Theoretical value for nominal voltage of a new battery.
Manufacture Date (DD:MM:YY) : The date the battery pack was manufactured.
Manufacturer Name: Acronym of the battery pack manufacturer name.
Device Name: Battery pack model name.
Device Chemistry: Battery chemistry of the cells used.
Therm. Status from charger: Status of the battery thermistor or code resistor read by Smart Battery
Charger IC. The thermistor or code resistor is always connected to the charger whenever the
corresponding battery is connected to the charger and SMBus.
5-18
Document no. 2081505-001
Frame
Smart Batt2
If Smart Battx is selected for a battery NOT connected to the SMBus, the menu contains the
following:
Battx information from Memory and PMC (This information comes from the power Board
memory or is measured by the power Board. SMBus data in this menu is not real time, because
this battery is not connected to the SMBus).
NOTE: This page may not contain information if SMBus has been connected only to the other
battery. Page can be updated by battery disconnection and reconnection, if desired.
Rel. State Charge: Relative state of charge of the
battery. Expressed as a percentage of Rem. Cap.
(mAh) / Full Cap.(mAh).
WPM Battery
Remaining Capacity: Remaining battery capacity
(mAh).
Smart Batt1
Full Charge Capacity: Capacity of the battery
when it is fully charged.
Design Capacity: Theoretical capacity of a new
battery.
Batts
Smart Batt2
Batt2 information from Memory and PMC
Rel. State of Charge
Remaining Capacity
Full Charge Capacity
Design Capacity
Design Voltage
Manufacture Date (DD:MM:YY)
0%
0 mAh
0 mAh
0 mAh
0 mV
00/00/00
Clear Temp Maxs
Previous Menu
Design Voltage: Theoretical value for nominal
voltage of a new battery.
Manufacturer Date (DD:MM:YY): The date the
battery pack was manufactured
Manufacturer Name
Device Name
Device Chemistry
DC/DC Board A/D
Batt1 Voltage
Batt2 Voltage
Batt Current
Batt Not CHG Temperature
LION
12.00 V
12.34 V
-0.01 A
32.24 C
Manufacturer Name: Acronym of the battery pack
manufacturer name.
Device Name: Battery pack model name.
Device Chemistry: Battery chemistry of the cells
used.
Batt1 Voltage: Battery A voltage measured at the
power Board.
Batt2 Voltage: Battery B voltage measured at the power Board.
Batt Current: Battery current (discharge or charge) for the battery connected to SMBus.
Measured at the power Board.
Batt Not CHG Temperature: This is subject to change.
Clear Temp Maxs
This command is useful only when the WPM Battery Batts view is selected.
The Clear Temp Maxs command clears the maximum values of Batt Temp (SMBus) and Batt
Temp (PMC).
Note: Power temp and CPU temp maxs are not cleared.
5-19
Document no. 2081505-001
B40/B20 Patient Monitor
4
Keyboard
The service menu for testing the command board functions.
Red Led is for testing the red alarm light on the
monitor. When the text is highlighted, the red alarm
light can be turned on and off by pressing the Trim
Knob.
Yellow Led is for testing the yellow alarm light on the
monitor. When the text is highlighted, the yellow
alarm light can be turned on and off by pressing the
Trim Knob.
Cyan Led is for testing the cyan alarm light on the
monitor. When the text is highlighted, the cyan alarm
light can be turned on and off by pressing the Trim
Knob.
Dummy Press is for testing the Trim Knob. When the
text is highlighted, pressing the Trim Knob creates a
sound from the loudspeaker and the corresponding
number on the service data field increases.
Keyboard
Service Data
Red Led
Message count
0
Leds red OFF yellow OFF cyan OFF
Yellow Led
Direct action keys
Cyan Led
Dummy Press
Admit/ Pt. Data SpO2
Dischar & Trends
Keyboard Log
NIBP
Previous Menu
Invasive Normal
Pressures Screen
Monitor
Setup
Print/
Record
Airway
Gas
Others
Silence
Alarms
Alarms
Setup
Zero
All
Auto
On/Off
Start
Cancel
Start
Stop
Control wheel
Press
0
Clokwise
0 Counterclokwise
Service Data
Message Count counts the number of messages that are sent out to the main CPU board.
Leds upper and lower indicate the states of the alarm lights on the monitor.
Direct action keys texts are indications to the command board membrane keys. When a key
on the command board is pressed, the corresponding text in the menu changes its color.
Control wheel, Press counts the Trim Knob pressings.
Control wheel, Clockwise and Counter clockwise indicate the Trim Knob turnings.
5-20
Document no. 2081505-001
ECG
0
Keyboard
4.1 Keyboard Log
All the keyboard presses and the commands given by the Trim Knob are recorded in the
Keyboard Log. The length of the log is 80 events. The log is FIFO type.
Scroll Log: enables to scroll the keyboard log.
Scroll Stat: enables to scroll the keyboard
presses events.
Record Log: to record keyboard log.
Record Stat: to record keyboard stat.
Reset Log: to reset the keyboard log.
Keyboard
Keyboard Log
Scroll Log
Scroll Stat
Keyboard
: Keyboard Log
2004- Jan- 29 05:40:54
Record Log
Service Menu
: Keyboard
2004- Jan- 29 05:40:40
: Previous Menu
2004- Jan- 29 05:40:39
Record Stat
Display
Reset Log
Previous Menu
Service menu
Frame
Network
Network Config
TCP/IP
TCP/IP Config
: Display
2004- Jan- 29 05:40:11
: Previous Menu
2004- Jan- 29 05:40:09
: Previous Menu
2004- Jan- 29 05:40:05
: Previous Menu
2004- Jan- 29 05:40:00
: Previous Menu
2004- Jan- 29 05:39:57
: Previous Menu
2004- Jan- 29 05:39:40
5-21
Document no. 2081505-001
B40/B20 Patient Monitor
5
Parameters
NOTE: Parameter values in Service Data fields are only for reference in this section.
5-22
Document no. 2081505-001
Parameters
5.1 Gas Unit
5.1.1 General
The monitor starts counting these items at power up and resets to zero at power off. The
values may also be reset when a module is attached to the monitor frame and be set to 32769
or continuous counting may be started when the module is removed from the monitor frame.
The nonzero values do not indicate a failure, but the continuous counting (more than 5 per
second) or value 32769 indicates either a serial communication failure or a module not in
place. Also failures in other modules may cause these numbers to rise or be set to 32769.
Module configuration shows which measurement
options are available, i.e. are detected by the module.
Timeouts is a cumulative number that indicates how
many times the module has not responded to the
monitor's inquiry.
Bad checksums is a cumulative number that indicates
how many times communication from the module to
monitor has broken down.
General
Previous Menu
Service Data
Module configuration
MiniC CO2 O2 N20 AA id p&v GasExch
1 0
0
0 0 0
0 0
0 = not available
1 = available
Bad c-s by mod is a cumulative number that indicates
how many communication errors the module has
detected.
Timeouts
-12867
Bad checksums
0
Bad c-s by moc
0
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Document no. 2081505-001
B40/B20 Patient Monitor
5.1.2 Gases
Noise Meas
activates the noise measurement.
Sample gain adj adjusts the sampling pump gain, i.e.
for adjusting the sample flow
measurement.
Pump ctrl
A manual control for the sampling
pump.
Zero valve ctrl A manual control for the zero valve.
Gases
Noise Meas
Sample gain adj
Pump ctrl
Zero valve ctrl
Previous Menu
Serivce Data
OFF
noise-%
mv
Gain
O2
--------CO2
0.00 300.0
2826
1.010
N20
--------AA1
A
AA2
----- B
--ID
--C
--ID unrel.
--D
--E --MAC
Sample Flow 148.7
Zero 0.0ml/min
Gain 1.000
Ambient
1013
Amb- Work 49.6mbar
%
OFF
Fall time CO2
CO2-02 Delay
--02
0ms
---ms
Pump ON
0.97%
1881mV
Lamp ON 56.23%
75mA
Fan ON
Zero Valve MEAS Occl Valve
MEAS
Temp TPX 45.6 CPU 0.0
Time after power on
OM
54min
0.0
Service Data
O2, CO2, N2O, AA % shows real-time concentrations.
noise-%
is standard deviation of concentration.
O2, CO2, N2O, AA channels A-E mV: signal is scaled to mV.
Gain
User gain. It is scaled as (User gain)/(Factory gain).
ID
Identified agent.
ID unrel.
The shown value tells how unreliable the identification is. With pure agent the value is normally
<50.
MAC
MAC value
Sample Flow
calculated from differential pressure and adjusted by the module. Zero value as measured
during initialization when the pump is off. Gain: sample flow measurement can be calibrated
by adjusting the gain.
Ambient
Ambient pressure is measured every 30 min.
Amb-Work
Ambient pressure - sampling system internal pressure.
Fall time
CO2 and O2 in ms. For N2O and AA same as CO2.
CO2-O2 Delay
In ms. No delay between CO2, N2O, and agents.
Pump
Can be toggled ON/OFF. PWM output 0-100% is shown. Pump voltage is also shown.
Lamp
The state, PWM control, and current of the lamp are shown.
Fan
The state of the fan is shown.
Zero and Occl Valve Can be toggled between measurement state (MEAS) and zeroing/occlusion states
(ZERO/OCCL).
Temp
Temperatures measured by the module from TPX, CPU, and OM.
Time after power on In minutes after power on.
5-24
Document no. 2081505-001
Parameters
5.2 ECG Module
Power Freq is used to changing the power frequency for ECG module, it can display in Service
Data’s view. To press this menu, change 50 Hz to 60 Hz, or 60 Hz to 50 Hz.
Service Data
Power Freq shows the mains frequency selected: 50
Hz / 60 Hz
ECG Module
Serivce Data
Power Freq
Cable type
Electrode
50 Hz Quick Zero
5 lead Artifact
RA LA LL V1
ON ON ON OFF
V2
V3 V4 V5
0FF OFF OFF ON
0
0
RL
ON
V6
OFF
Pacer vount
0
R count
4625
Electrode shows ON when each of these electrodes is
connected.
Resp: Avail
Zeroing
1
0
Value
MeasOff
20
0
Pacer count is a running number of detected
pacemaker spikes.
Arrhythmia
HR 80
QRS count
Det leads1
Data -73
0
HR25
4607
6
-12
On/ Off
80
HR75
PVC
nroleads
Noise M/A
1
80
0
2
0
RAM
ROM
EEPROM
MissedPkgs
OK
OK
OK
4
Cable type shows the leadwire set connected: 3 lead /
5 lead
ECG Setup
Quick Zero shows 1 when the ECG signal is beyond
scale, and therefore, is quickly returned to the optimal
range with fast signal processing methods.
Previous Menu
Power Freq
Artifact shows 1 when artifacts are detected.
R count is a running number of detected R waves.
Resp: Avail shows if a module with impedance
measurement is plugged (1) or not plugged (0) into the
monitor.
Value shows the measured respiration rate value for
impedance respiration.
Timeouts
6
Bad Checksum 0
Bad cs-by mo 0
Leads Off
0
Zeroing indicates the zeroing status of the respiration measurement: 1 = zeroing, 0 = not zeroing.
MeasOff shows 1 if the respiration measurement is set to OFF, and 0 if the the respiration
measurement is set to ON.
Arrhythmia shows an active arrhythmia alarm (VFIB, VTAC, ASY).
On/Off shows 1 if arrhythmia analysis is active and 0 if it is not active.
HR, HR25 and HR75 for R&D purpose only
QRS count shows the running number of detected QRS complexes.
PVC shows the PVCs detected per minute
Det leads shows the leads that are being used for detecting beats and ventricular fibrillation. The
selection of user leads (ECG1, ECG2, ECG3) on the monitor affects the leads used for detection. The first
lead used for detection is lead either I or II. The algorithm uses the lead appearing first in user leads. The
second lead used for detection is one of the precordial leads (V1 - V6): -1 = invalid (not used), 0 = lead I,
1 = II or III; 2 = V1, 3 = V2, 4 = V3, 5 = V4, 6 =V5, 7 = V6
nroleads shows the number of leads that are beign used for detecting beats and ventricular fibrillation.
Possible values include: 0 , 1 and 2 (ref. Det leads) analysis.
Data for R&D purpose only
Noise M/A for R&D purpose only
Timeouts is a cumulative number that indicates how many times the module has not responded to the
monitor’s inquiry.
Bad checksums is a cumulative number that indicates how many times communication from the
module to the monitor has broken down.
5-25
Document no. 2081505-001
B40/B20 Patient Monitor
Bad c-s by mod is a cumulative number that indicates how many communication errors the
module has detected.
The monitor starts counting these items at power up and resets to zero at power off. The values
may also be reset when a module is attached to the monitor frame and be set to 32769 or
continuous counting may be started when the module is removed from the monitor frame.
The nonzero values do not indicate a failure, but the continuous counting (more than 5 per
second) or value 32769 indicates either a serial communication failure or a module not in place.
Also failures in other modules may cause these numbers to rise or be set to 32769.
RAM indicates the state of the RAM memory.
ROM indicates whether the checksum at the EPROM is in accordance with the one the software
has calculated.
EEPROM indicates if the values stored in the permanent memory are valid.
The state is either OK, Fail or ? (module not in place or a communication error).
LeadsOff indicates whether the monitor can measure ECG even if one or more leadwires are off:
1 = measurement is not possible, 0 = measurement can be done.
MissedPkgs indicates the number of packages missed.
5.2.1 ECG Setup
Filter filters the ECG signal high frequency noise and
slow respiratory artifacts:
-
-
-
ECG Module
Monit (monitor) filter is used in routine monitoring.
It effectively filters the artifacts caused by the
electrosurgery unit and respiration.
Diagn (diagnostic) filter is used if more accurate
information of the waveform is needed (e.g. of
P-wave or AV block). The diagnostic filter is more
susceptible both to high frequencies and baseline
wander than the monitor filter.
STfilt (ST filter) permits more accurate information
of ST segment. It filters the high frequency artifacts
caused by the electrosurgery unit, but catches the
slow changes in ST segment. The ST filter is more
susceptible to baseline wander than the monitor
filter.
Pacemaker selects how to display the pacing pulse of
cardiac pacemaker. The selections are Show, Hide
and Sensit:
-
Hide: the pacing pulse is filtered away from ECG
data.
-
Show: the pacer pulse is filtered away from ECG
data but the pulse is displayed as a constant
height marker.
-
Sensit: uses a more sensitive pacemaker
detection. Pacemaker spike is displayed on ECG.
5-26
Document no. 2081505-001
Service Data
ECG Setup
!
Filter
STfilt
Pacemaker
Hide
Monit
STfilt
Previous Menu
Diagn
Quick Zero
0
Artifact
0
LL V
RL
ON OFF ON
V4 V5 V6
OFF OFF OFF
Rcount
0
Value
MeasOff
On/Off
--1
0
HR75 ---
PVC
0
nroleads
0
Noise M/A 0
0
Use ST filter for optimal
ST analysis.
RAM
ROM
EEPROM
MissedPkgs
OK
OK
OK
0
Parameters
5.3 STP Module (for GE SpO2)
Record Data prints out the shown service data and board information (id, serial number and
sw id) onto the recorder.
Temp Test activates the automatic temperature test for the temperature channels T1 and T2.
The result from the test is shown in the service data field.
NOTE: The Temp Test needs to be selected twice before the test starts.
Service Data field
Gain is a coefficient to compensate gain error. Usually
the values for P1 and P2 are between 17000 and 25000
and for T1 and T2 between 13000 and 14300.
Zero indicates the offset compensation value of each
parameter in the A/D converter. Typically the values for
P1 and P2 are within ±1000 and for T1 and T2 between
-150 and +300. Calibrate if zero and/or gain value is
outside the ranges.
STP Module
Calibrations
Record Data
Temp test
Previous Menu
Cable shows ON when a corresponding cable is
connected to the front panel
Probe shows ON when a corresponding probe is
connected to the cable.
Value shows the measured numeric values
simultaneously. Pressure values are real time values
and shown in mmHg. Temperature values are shown in
degrees Celsius.
Serivce Data
Gain
Zero
Cable
Probe
Value
P1
P2
T1
11161 11163 -7562
-10295 -10295 9674
ON
ON
ON
ON
ON
ON
76./4
/.94
3/.09
Buttons
OFF
OFF
SpO2
Modpr
Hr
Cable
Probe
OK
------ON
ON
Ired Int.
Red Int.
DC gain
IDC
RDC
AC gain
Pre gain
OFF
Temp error
Temp test
T2
-7569
9695
ON
ON
3/.09
71
70
5
14115
11193
0
0
OFF
OFF
Protect key
ON
Protect mode ON
Configuration STP
Timeouts
Bad checksums
Bad c-s by mode
SpO2 shows the measured beat-to-beat SpO2 value.
Modpr is a modulation % that indicates the AC/DC ratio in the measured signal.
2
0
0
RAM
ROM
EEPROM
OK
OK
OK
Hr is a pulse rate calculated from every beat.
Cable and Probe can be either OFF or ON, and these indicate the state PROBE OFF.
Under them there is a message field for SpO2. It can be OK, PULSE SEARCH, CBL OFF, PROBE OFF, NO
PULSE, ARTEFACT, POOR SIGNAL, or CHECK PROBE.
Balance between leds is adjusted by changing the intensity of red/infrared. Intensity of infrared (Ired
Int.) is in the range of 40 to 255 and red intensity (Red Int.) is in the range of 40 to 255.
DC gain shows the gain of DC signal adjusted by the module.
IDC is the value of infrared signal.
RDC is the dc value of red signal.
AC gain is the gain of infrared and red ac signals. AC gain values can be 1 or 0. Value 1 means high ac
gain and 0 means low gain.
Pre gain is a preamplifier gain for infrared and red signals. Pre gain values can be 1 or 0. Value 1 means
normal operation. Value 0 means that signal levels are very low and extra gain is taken into use.
5-27
Document no. 2081505-001
B40/B20 Patient Monitor
Temp error shows the status of the temperature test. No errors found show the
status (OFF) and errors found (ON).
Protect key and Protect mode show normally ON but can be turned to OFF for
the temperature calibration in Calibration Menu.
Configuration shows the chosen module configuration: T, P, TP, ST, or STP.
Timeouts is a cumulative number that indicates how many times the module
has not responded to the monitor’s inquiry. Bad checksums is a cumulative
number that indicates how many times communication from the module to the
monitor has broken down.
Bad c-s by mod is a cumulative number that indicates how many
communication errors the module has detected.
The monitor starts counting these items at power up and resets to zero at
power off. The nonzero values do not indicate a failure, but the continuous
counting (more than 5 per second) indicates either a serial communication
failure, or a module not in place. Also other modules can cause communication
errors that cause these numbers rise.
RAM indicates the state of the RAM memory.
ROM indicates whether the checksum at the EPROM is in accordance with the
one the software has calculated.
EEPROM indicates if the values stored in the permanent memory are valid.
The state is either OK, Fail or ? (module not in place or a communication error).
5-28
Document no. 2081505-001
Parameters
5.3.1 Calibrations
Protection: Protection for the configuration and
temperature calibrations can be set ON and OFF.
STP Module
Service Data
Calibrations
Calibrate T1 / Calibrate T2: The functions are for
calibrating the temperature channels T1 and T2.
Protection
Calibrate P1/ Calibrate P2: The functions are for
calibrating the invasive blood pressure channels
P1 and P2.
ON
Calibrate T1
Calibrate T2
Calibrate P1
Calibrate P2
Previous Menu
T2
T1
5185 15196
33
34
ON
ON
ON
ON
: 6./ 4 3/ .05
OFF
int.
220
int.
220
ain
110
2047
2047
OFFin
0
gain
1
OFF
Calibrate transducer with
manometer. push Comwheel to
start zeroing.
2
0
0
OFF
OK
RAM
OK
ROM
EEPROM OK
How to calibrate T1/ T2
The calibrations are possible only when the protection is set OFF. The temperature calibration
requires accurate test plugs of value 25 °C and 45 °C.
1.
Select Calibrate T1/Calibrate T2
2.
Insert the test plug 25 °C into the T1/T2 connector
3.
Press the Trim Knob
4.
Insert the test plug 45 °C into the T1/T2 connector
5.
Press the Trim Knob
How to calibrate P1/ P2
NOTE: Before starting the pressure calibration, disconnect all patient cables and discharge the
patient.
The calibrations require a pressure transducer (with appropriate cable) and a pressure
manometer.
1.
Connect the pressure transducer with the pressure manometer to the P1/P2 connector.
Select Calibrate P1/Calibrate P2. Leave the transducer to room air pressure.
2.
Press the Trim Knob to start zeroing.
3.
Supply a pressure of 100 mmHg to 300 mmHg to the transducer. The recommended
pressure is 200 mmHg.
4.
Set the pressure on the display to match the pressure reading on the manometer and
press the Trim Knob.
5-29
Document no. 2081505-001
B40/B20 Patient Monitor
5.4 NIBP Module
Service Data
Pressure shows the measured pressure multiplied
by 10. This value is automatically zero-drift
compensated.
Zero shows the difference between the zeroing
value in the permanent memory (stored when the
module is calibrated) and the current automatic
zero-drift compensation multiplied by 10. The value
can change between +20 and -20 mmHg. If the zero
drift exceeds ± 10 mmHg, the module should be
recalibrated.
AD0 to AD7 show the values of each eight channels
of the A/D converter.
ST1: Master status, indicate measurement,
calibration, zeroing whether ongoing
ST2: Button status, Not used yet.
ST3: Hardware status, indicate the power supply
status, ADC error status.
ST4: Measurement result status, indicate whether
measurement is ready, whether cuff ID is updated
NIBP Module
Calibrations
Safety Valve
Pnematics
Previous Menu
Service Data
Pressure
Zero
B1
000000
-00010
B2
000000
000000
St1
St2
St3
St4
0000
0000
0400
0000
AD0 -17
6
AD1
-1
AD2
AD3 1502
2
AD4
AD5 -1644
5
AD6
AD7 -1505
ON
OFF
OFF
Offset
Gain
Timeouts
Bad checksums
Bad c-s by mod
B1
000103
000041
B2
000096
000041
2
0
0
OK
RAM
OK
ROM
EEPROM OK
Offset show the offset values for B1 and B2 ( pressure sensor calibration factors).
Gain show the gain values for B1 and B2 ( pressure sensor calibration factors).
Timeouts is a cumulative number that indicates how many times the module has not responded to
the monitor’s inquiry.
Bad checksums is a cumulative number that indicates how many times communication from the
module to the monitor has broken down.
Bad c-s by mod is a cumulative number that indicates how many communication errors the module
has detected.
The monitor starts counting these items at power up and resets to zero at power off. The nonzero
values do not indicate a failure, but the continuous counting (more than 5 per second) indicates
either a serial communication failure, or a module not in place. Also other modules can cause
communication errors that cause these numbers rise.
RAM indicates the state of the RAM memory.
ROM indicates whether the checksum in the EPROM is in accordance with the one the software has
calculated.
EEPROM indicates if the values stored in the permanent memory are valid. The state is either OK,
Fail or ? (module not in place or a communication error).
5-30
Document no. 2081505-001
Parameters
5.4.1 NIBP Calibration
Active Leak Test: Wrap an adult cuff around a pipe
and connect the cuff to the module. Select the active
leak test (ON). The module automatically pumps a
pressure of 280 mmHg into the cuff. Wait for several
seconds until the pressure stabilizes. Then check
that the pressure reading does not drop more than 6
mmHg per minute. If it does, leaking point(s) should
be detected and fixed. Cancel the test by selecting
the Active leak test OFF.
NIBP Module
Service Data
Calibration
Active Leak Test
OFF
Calibration Check
OFF
Protection
OFF
B1
00
10
AD0 -17
6
AD1
-1
AD2
AD3 1502
2
AD4
AD5 -1643
5
AD6
AD7 -1505
Calibrate
Previous Menu
Calibration Check: After the calibration check is
selected (ON), the module zeroes the pressure
transducers at the beginning of the calibration
check. Do not pump pressure until the text ‘Zeroed’
appears in the NIBP digit field or the zeroing will fail.
After the zeroing is done, manually pump pressure
into the module and make sure that the same
pressure values are shown both on the display and
on the manometer. Pressure of both pressure
channels B1 and B2 are shown. The pressure values
are automatically zero-compensated, so the
readings of B1 and B2 should be the same as the manometer readings.
B2
000000
000000
2
0
0
OK
RAM
OK
ROM
EEPROM OK
Protection: Software calibration protection (ON/OFF). Select OFF when calibrating.
How to calibrate
NOTE: Perform NIBP Calibration Check first to evaluate if calibration is needed or not.
NOTE: Both transducers B1 and B2 will be calibrated simultaneously.
NOTE: The module must be in the frame during the whole procedure.
NOTE: Calibration selection is available only when protection is OFF.
1.
Change the protection setting from ON to OFF to enable the Calibrate selection - the
color of the Calibrate selection changes from grey to white.
2.
Zeroing:
−
Disconnect the NIBP hose from the module connector.
−
Select Calibrate and push the Trim Knob.
NOTE: Messages ‘Zeroing’ and ‘Zeroed’ is shown in the NIBP message field and next to the
Calibrate selection momentarily. After this, a pressure bar will appear beside the menu.
3.
Calibration:
−
Connect the NIBP hose to the module connector.
−
Connect an external manometer with a pump to both tubes of the hose.
−
Pump about 200 mmHg pressure.
−
Verify that both pressure values, B1 and B2, shown in the prompt field of the
calibration menu match the manometer reading. If not, adjust the by turning the
Trim KnobTrim Knob.
−
Press Trim Knob to complete the calibration.
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Document no. 2081505-001
B40/B20 Patient Monitor
NOTE: Messages ‘Calibrating’ and ‘Calibrated’ are shown in the NIBP message field and next to
the Calibrate selection.
NOTE: When calibrating NIBP, always change the displayed pressure value slightly with the
Trim Knob, even in cases where the value would be correct. For example, change the value one
step higher and then back one step lower. The ‘Calibrated’ text should appear in the display.
This ensures that the calibration procedure is correctly registered and stored by the module.
4.
Change the Protection setting from OFF to ON to disable Calibrate selection - the color of
the Calibrate selection changes from white to grey.
NOTE: If a long time not choose ON manually, this menu will automatically return to
Protection ON.
5.4.2 NIBP Safety Valve
Start test is for starting and Stop test for stopping the
Safety Valve test.
Safety Valve Data:
For information on general items Pressure, Zero, St1 to
St4, AD0 to AD7 as well as Timeouts etc., see service
data descriptions in section 4.4 NIBP Module.
Safety Valve
ADULT
Start Test
Previous Menu
Safety Valve Data
Pressure
Zero
B1
000000
000000
B2
000000
000000
St1
St2
St3
St4
0000
0000
0400
0000
AD0 -16
6
AD1
-1
AD2
AD3 1502
2
AD4
AD5 -1643
4
AD6
AD7 -1505
Max. press and 2 s after stop show the measured
values at Safety Valve test.
Max press
2 s after stop
Timeouts
Bad checksums
Bad c-s by mod
B1
0
0
B2
0
0
2
0
0
OK
RAM
OK
ROM
EEPROM OK
How to do safety valve test
1.
Disconnect the pressure manometer from the NIBP cuff connector. Connect the NIBP
hose and cuff to the NIBP cuff connector.
2.
Connect a standard adult cuff around some round object, for example a calibration gas
bottle.
3.
Perform a NIBP test by pressing NIBP Start/Cancel button (Waiting until the test ended).
4.
Select Start Test. Start the adult safety valve test by pressing the Trim Knob. Wait until the
pump stops and the pressure is deflated.
5.
Check the pressure values ‘Max press’ for both transducers. All the values should be
within 300 - 330 mmHg.
6.
Connect a neonatal hose and cuff around another round object, for example a calibration
gas bottle.
7.
Perform a NIBP test by pressing NIBP Start/Cancel button (Waiting until the test ended).
8.
Select Start Test. Start the neonatal safety valve test by pressing the Trim Knob. Wait until
the pump stops and the pressure is deflated.
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Document no. 2081505-001
Parameters
9.
Check the pressure values ‘Max press’ for both transducers. All the values should be
within 150 - 165 mmHg.
10.
Return to the normal monitoring mode by pressing Normal Screen.
5.4.3 NIBP Pneumatics
Start Pump/Stop Pump: A manual control for the pump.
The selection changes to Stop Pump when the pump turns
on.
Open Safe. Valve/Close Safe. Valve: A manual control for
the Safe valve. The selection changes to Close Safe Valve
when the valve is opened.
Open Defl. Valve/Close Defl. Valve: A manual control for
the deflation valve. The selection changes to Close Defl.
Valve when the valve is opened.
Pneumatics
Start Pump
Pneumatics Data
Pressure
Zero
B1
000000
-00010
St1
St2
St3
St4
0000
0000
0400
0000
B2
000000
000000
Open Safe. Valve
Open Defl. Valve
Reset Clock
Previous Menu
Reset Clock: Set up the Interval time 20 mmHg -> 185
mmHg to 0 s
Pump
Safety
Valve
CLOSED
OFF
Pneumatics Data field
For information on general items Pressure, Zero, St1 to
St4, AD0 to AD7 as well as Timeouts etc., see section "NIBP
Module."
AD0 -17
6
AD1
-1
AD2
AD3 1502
2
AD4
AD5 -1643
4
AD6
AD7 -1505
Deflate
Valve
CLOSED
Interval 20 mmHg -> 185 mmHg
Timeouts
Bad checksums
Bad c-s by mod
2
0
0
0s
OK
RAM
OK
ROM
EEPROM OK
Pump, Safety Valve, and Deflate Valve show their states.
How to check Interval 20 mmHg -> 185 mmHg
Select Start pump at different combinations of the valves open/closed and push the Trim
Knob. The module counts the time it takes for the pressure to go up from 20 mmHg to 185
mmHg and displays it. When all the valves are closed, the pump should be able to pump the
pressure in about 1 to 4 seconds into an adult cuff wrapped around a pipe. The pump does not
stop without selecting Stop Pump by pushing the Trim Knob.
NOTE: To redo the test, must go back to the previous menu.
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Document no. 2081505-001
B40/B20 Patient Monitor
5.5 SpO2 (for Masimo/Nellcor SpO2)
SpO2 Data
PR: Measured pulse rate value
SpO2%: Measured SpO2 value
NoProbe: If there is a probe connected
SpO2
Previous Menu
PulseSearch: If the pulse search is being
done.
SpO2 Data
PR
SpO2%
---------
NoProbe
PulseSearch
CheckProbe
1
0
0
QUART Status
POX Status
I/O Status
POX Error
0000
0000
9E08
0000
CheckProbe: If there is check probe error.
QUART Status: Show quart status.
POX Status: Show POX measurement
status.
I/O Status: Show IO status.
POX Error: Show POX error status.
For information on Timeouts etc., see
section "NIBP Module."
Return to
Previous menu.
Timeouts
Bad checksums
Bad c-s by mod
2
0
0
ROM
OK
5.6 Entropy
When the Entropy Service Menu is open, the function of Entropy module keys will be disabled.
Check Sensor: to replace module keys function to check the entropy sensor.
Module: to show the Module status in the right window.
Sensor: to show the Sensor status in the right window.
5-34
Document no. 2081505-001
Parameters
Module status
Measurement: show messurement status
Last Service: Service log
Entropy, Check sensor: to check the
module keyboard. Press the module keys,
these 2 items will highlight.
Main: If the pulse search is being done.
BSR status: show the status for Burst
supression classification. There are 4
status: Artefact; Supression; Burst; Invalid
(not used)
Artefact: artefect whether detected.
Diathermy: diathermy whether detected.
AD clipped: AD-converted value whether
clipped
Alg.ver.(Mon), Alg.ver.(Mod), Alg.ver.used:
These 3 items show version of entropy
algorithm, B40 always use algorithm from
monitor.
For information on Timeouts etc., see
section "NIBP Module."
Sensor status
Entropy, Check sensor: to check the
module keyboard. Press the module keys,
these 2 items will highlight.
Cable, Sensor: whether detect cable and
sensor.
Sensor S/N, Sensor Lot: show the sensor
information
Lead: whether detected each of 3 points
of sensor.
Imped.: imped. value for each of 3 points
of sensor.
Imp. Meas: whether Imped. measurement
on.
Imp.: whether is ok for Imped
measurement.
5-35
Document no. 2081505-001
B40/B20 Patient Monitor
6
Set/Test
The system contains a watchdog circuitry, which needs refreshment at every 10 seconds. If the
refreshment did not occur, the watchdog will reset the main CPU.
The purpose of the watchdog is to restart the monitor, if there was a serious malfunction. This
feature is useful in two cases: when the main CPU is not able to control the monitor, or when
the CPU controls the monitor but detects a serious malfunction. Watchdog tests check proper
functionality of the watchdog in various conditions.
Watchdog test ensures directly that the watchdog
functions properly. Choosing this test prevents the
watchdog from refreshing and shows running
seconds with an accuracy of 0.1 seconds.
The test should have the following result when the
watchdog is working properly: The monitor will
restart after 10 seconds from the start of the test. In
malfunction: ‘>20 s’ is displayed. In this case, the
fault is in the watchdog.
WD by Overload test ensures the functionality of a
feature, where the software controls the monitor,
but detects an overload situation in the main CPU.
The test should have the following result when the
feature is working properly: The monitor will restart
after 10 seconds from the start of the test.
Factory Reset restores the factory default settings
and clears the data memories. Factory reset should
be run if the monitor software is replaced or if the
Timekeeper battery is replaced.
5-36
Document no. 2081505-001
Service Menu
Set / Test
Sw version / Unit id
----------------------------
Watchdog
WD by Over load
Factory Reset
Previous Menu
------------------------------------------------------------------------------------------------------------------------------------------------------------------2, 2004-03-15
number:--------------------------------------------
Service Log
7
Service Log
Error, event and alarm data is stored in the Service Log.
The service log contains information about the occurred monitor errors, events and alarms
since the last factory reset or service log reset.
Error Log is for selecting the error history view onto
the right side of the menu. Error Log shows also
some monitoring events like warm and cold starts.
Alarm Log is for selecting the alarm history view onto
the right side of the menu.
Service Log
Error Log
Alarm Log
Scroll Log is for scrolling the error/alarm information
on the right side of the menu.
Scroll Log
Record Log is for recording the service log
information onto the recorder.
Reset Log
Record Log
Error History
Last errors:
2010-Nov-27 13:50:08
UMBC handler: LOG Msg<Umbc reset> at
UmbcChannel. cpp(189)
Previous Menu
Reset Log is for clearing up the content of the
selected service log. This function should be run after
a performed maintenance.
5-37
Document no. 2081505-001
B40/B20 Patient Monitor
5-38
Document no. 2081505-001
6 Field replaceable
unit
Spare part
1
Spare part
The following parts will be available as field replaceable spare parts.
1.1 Front cover
1.2 Back cover unit
6-1
Document no. 2081505-001
B40/B20 Patient Monitor
1.3 Frame
1.4 Extension rack
6-2
Document no. 2081505-001
Spare part
1.5 Hemo box
1.6 FRU parts list
Item
Description
Order Code
Product
2
FRU B40V2 Tian Ma LED Backlight Display Module
2061869-008
B40
2
FRU B20B30 10.4 INCH COLOR TFT-LCD
2044978-071
B20
2,3
FRU B20B30 10.4 INCH LCD WITH BACKLIGHT DRIVER BOARD
2044978-073
B20
3
FRU B40V2 Tian Ma LED Backlight Display Convert
2061869-009
B40
3
FRU B20B30 LED BACKLIGHT DRIVER BOARD
2044978-072
B20
4
FRU B40B20 EXTERNAL INTERFACE BOARD
2053489-004
B40, B20
6
FRU B40B20 user Interface board
2053489-006
B40, B20
7
FRU B40B20 Speaker
2053489-007
B40, B20
8
FRU B40 Frame cables and mechenical parts
2053489-008
B40
8
FRU B20 FRAME CABLES AND MECHENICAL PARTS
2053518-004
B20
11
FRU B40B20 battery board
2053489-011
B40, B20
12
FRU B40B20 AC/DC unit
2053489-012
B40, B20
13
FRU B40B20 AC inlet
2053489-013
B40, B20
15
FRU B40V2 Handle
2061869-013
B40, B20
21
FRU B40B20 Trim Knob
2053489-021
B40, B20
24
FRU B40B20 Module interface board
2053489-024
B40, B20
43
FRU BX0 B1X5 HEMO NELLCOR (SPO2, TEMP, IBP) (ROHS) FOR
NEW DUMP VALVE
2053489-093
B40, B20
44
FRU BX0 B1X5 HEMO MASIMO(SPO2, TEMP, IBP) (ROHS) FOR
NEW DUMP VALVE
2053489-092
B40, B20
45
FRU BX0 B1X5 HEMO GE STP (SPO2, TEMP, IBP) FOR NEW DUMP
VALVE
2053489-091
B40, B20
46
FRU BX0 B1X5 HEMO GE SPO2 (SPO2 ONLY) FOR NEW DUMP
VALVE
2053489-094
B40, B20
47
FRU B40B20 PRINTER (ROSH)
2053489-062
B40, B20
48
FRU B40B20 Recorder connect board (ROSH)
2053489-063
B40, B20
6-3
Document no. 2081505-001
B40/B20 Patient Monitor
Item
Description
Order Code
Product
49
FRU B40B20 RAC flex cable
2053489-049
B40, B20
51
FRU B40B20 Adapter (ROSH)
2053489-061
B40, B20
53
FRU B40 ALARM LIGHT
2053489-053
B40
53
FRU B20 ALARM LIGHT
2053518-010
B20
54
FRU B40V2 Battery Cover
2061869-014
B40, B20
64
FRU B40B20B30 BATTERY
2044978-004
B40, B20
69
FRU B40V2 Front Cover without Keypad*
2061869-002
B40
69
FRU B20V2 Front Cover without Keypad*
2061869-056
B20
70
FRU B40V2 Rack Cover
2061869-003
B40, B20
71
FRU B40V2 Power Board
2061869-004
B40, B20
79
FRU B40V3 B20V2 KEYBOARD/MEMBRANE*
2061869-054
B40, B20
-
CABLE RS232 0.76 M
2025963-001
B40, B20
NOTE: Please buy this part locally. MPN: CS2N9MF-2.5
NOTE: 2061869-054 FRU B40V3 B20V2 keyboard/Membrane Switch includes multi-languages labels. When service people
replace front cover, please order both 2061869-002 and 2061869-054 for B40; both 2061869-056 and 2061869-054 for B20.
1.7 Other parts
The following parts have their own instructions accompanying with the FRUs.
Description
Order Code
Product
FRU B40V3 B20V2 Software Recovery CD
2061869-052
B40, B20
FRU B40V3B20V2 SOFTWARE RECOVERY CD VSP-C 1.01 SPA01
2061869-085
B40, B20
FRU B40V3B20V2 SOFTWARE RECOVERY DVD VSP-C 1.01 SPA01 2061869-086
AND LATER
B40, B20
FRU B40B20 HEMO NIBP FIRMWARE
2053489-077
B40, B20
FRU B20B40 HEMO ECG FIRMWARE
2053489-078
B40, B20
FRU BX0 FILTER POROUS PLASTIC 20U
2061869-088
B40, B20
FRU B20B40 HEMO DUMP VALVE SUB ASSY
2053489-066
B40, B20
FRU B40B20 HEMO LABELS
2053489-080
B40, B20
1.8 DRU Parts
More details , please refer to 2062418-001 Service instruction for depot.
Description
Order No.
DRU B40B20 CPU BOARD
2053489-014
DRU B40B20 CPU BATTERY
2053489-005
DRU B40B20B30 Module PCBA ECG
2061869-096
6-4
Document no. 2081505-001
Spare part
Description
Order No.
DRU B40B20B30 Module PCBA STP
2044978-026
DRU B40B20 HEMO COVER
2053489-027
DRU B125B105 HEMO NIBP PUMP
2098800-118
DRU B40B20 GE SPO2 BOARD PCBA
2053489-029
DRU B40B20 HEMO PCBA NIBP
2053489-031
DRU B40B20 HEMO NIBP HOSE CONNECTOR
2053489-032
DRU B40B20 HEMO NIBP TUBE AND CABLES
2053489-033
DRU B40B20 HEMO FLEX CABLES
2053489-035
DRU B40B20 HEMO ECG INPUT UNIT
2061869-095
DRU B40B20 HEMO STP INPUT UNIT
2053489-037
DRU B40B20 MASIMO SPO2 BOARD (ROSH
COMPLIANT)
2053489-058
DRU B40B20 NELLCOR SPO2 BOARD (ROSH
COMPLIANT)
2053489-057
DRU B40B20 HEMO PCBA TP K10 FOR MASIMO
SPO2
2104018-001
DRU B40B20 HEMO PCBA TP FOR NELLCOR SPO2
2053489-042
DRU B40V2/V3 REAR COVER
2061869-005
DRU B20V2 REAR COVER
2061869-055
DRU B40V2/V3 MAIN CHASSIS
2061869-006
DRU B20 MAIN CHASSIS
2053518-011
DRU B40B20 COVER ISOLATION ECG BOARD
2053489-081
6-5
Document no. 2081505-001
B40/B20 Patient Monitor
2
Disassembly
WARNING
CAUTION
A short circuit may cause internal damage. Do not touch any exposed
wiring or conductive surface inside, this may cause an electric shock.
Perform leakage current measurement whenever service or repair has been
done in the monitor.
Field repair of the patient monitor is limited to replacing Field Replaceable Units (FRUs). See “1.
Spare part” for a detailed list of available FRUs. Attempting a field repair on a printed circuit
board or a factory sealed component or assembly could jeopardize the safe and effective
operation of the monitor.
NOTE: Only a qualified service technician should perform field replacement procedures.
NOTE: Perform the checkout procedure described in chapter 3 “4. Maintenance and checkout”
after you have disassembled and reassembled the module.
2.1 ESD precautions
Refer to 1.2.4. ESD precautionary procedures in Chapter 1.
2.2 Reassembly precautions
GE recommends using the new fasteners (screws, washers, etc.) provided in the FRU kits rather
than re-using the old fasteners. Some fasteners are not intended to be re-used more than
three times. Use only new screws attaching into aluminium. Take advantage of existing thread
pattern cut by turning the screw counterclockwise until it drops into the existing thread
pattern.
•
When reassembling the monitor, comply with the given torque [x Nm] for the screws.
Note the positions of any wires, cables or connectors. Mark them if necessary to ensure
that they are re-assembled correctly.
•
Save and set aside all hardware for reassembly.
2.3 Required tools
•
•
•
Insulated screwdrivers; PH2, PO1, PH1, Hex 5.5 (recommend the length > 65 mm)
Insulated Flat blade screwdriver 3 mm
Antistatic wristband
2.4 Before disassembly
NOTE: Wear a grounded, antistatic wristband when handling PC boards. Electrostatic
discharge may damage components on the board.
−
Turn the monitor off from the On/Off button.
−
Disconnect the monitor power cord first from the wall outlet and then from the monitor.
−
Remove the battery.
−
Disconnect all external cables connected to the monitor.
−
Detach the E module from the frame.
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Document no. 2081505-001
Disassembly
−
Detach the monitor from the mount if installed.
2.5 To separate the frame
To separate the extension rack,
hemo module and multi I/O from
the frame
1. Remove the 2 screws from the bottom of the frame
NOTE: When place the monitor face down, be careful of the
screen and the Trim Knob.
2. Remove the screw beside the monitor.
NOTE: When assembly the extension rack, please install this
screw first before 2 screw in the bottom
3. From the back side of the monitor, pull the extension rack
out of frame, grasp it firmly.
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B40/B20 Patient Monitor
4. Open the battery’s cover, use a screwdriver to release the
latch by pivoting the screwdriver away from the monitor.
NOTE: Using the 3 mm Flat blade screwdriver into the small
hole inside, pull the latch to the screen side.
5. Using the screwdriver to pry the module from the monitor at
the same time.
6. Pull the hemo module out of the monitor.
7. Use the screwdriver to prize, pulling out the multi I/O at the
same time.
6-8
Document no. 2081505-001
Disassembly
2.6 To disassemble the frame
-
Remove the 2 screws from the back side of the frame, open
the cover.
-
Remove the 4 screws from top of the frame
-
Remove other 3 screws from the frame
-
Lift the back cover up
To open the back cover of the
frame
To change the handle
After opening the back cover
-
Remove 2 screws for the handle.
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B40/B20 Patient Monitor
To remove the front cover
To remove the alarm light board
-
For B40: Remove 4 screws by the side of the frame.
-
For B20: Remove 4 screws by the side of the frame, and 1
screw on the middile of the frame.
-
Disconnect the alarm light cable
-
Disconnect the connection cable
-
Open and remove the front cover from the frame
After opening the front cover
-
Remove 2 screws, the alarm light board is on the top of the
front cover.
To remove the user interface board After opening the front cover
6-10
Document no. 2081505-001
Disassembly
-
Remove 2 screws, the user interface board is on the bottom
of the front cover
-
Disconnect the Trim Knob cable
-
Disconnect the keyboard/membrane switch cable
-
Remove 4 screws from beside the display
-
Disconnect the display inverter cable and remove the screw.
-
Disconnect the display cable on the bottom side of the
screen
-
Remove the display
To separate the display
NOTE: When reassemble the display, be careful that no dirt or
finger prints are left.
To remove the loudspeaker unit
After removing the display
-
Disconnect the cable from CPU board
-
Remove 2 screws for the loudspeaker
To remove the ACDC unit
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B40/B20 Patient Monitor
-
Remove screw
-
Disconnect the cable to power board.
-
Disconnect the cable to ethenet board
-
Slightly lift the front of the ACDC unit, push the whole ACDC
unit to top direction.
-
Lift the unit up
-
Disconnect the cable to power board
-
Disconnect all the rest cables from the CPU board
-
Separate the whole unit from the frame
-
Remove 3 screws for ethenet board
-
Lift up the ethenet board from the frame
To remove the ethenet board
To remove the CPU board
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Document no. 2081505-001
Disassembly
-
Remove 4 screws for the CPU Board
NOTE: Replace the CPU battery every 5 years.
-
Carefully disconnect the CPU board from the power board,
and remove it out.
-
Remove the rest 7 screws off
-
Carefully disconnect the CPU board from the power board,
and remove it out first
-
Remove the battery board out of the frame
-
Remove the 2 screws and separate the board from the unit
To remove the power board and
battery board
To remove the inverter board
To remove the ACDC board
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B40/B20 Patient Monitor
-
Remove the four screws in ACDC board
-
Disconnect the cable from the AC inlet
-
Lift up ACDC
-
Disconnect the cable from from the module interface board
-
Remove 2 screws and then remove the module interface
board
To remove the module interface
board
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Document no. 2081505-001
Disassembly
2.7 To disassemble the extended rack and the recorder
To remove the recorder
-
Use the flat blade screwdriver to press the
lock through the hole inside.
-
Pulling the recorder out at the same time
-
Remove the 5 screws on the box
-
Lift the cover up
To open the extended rack box
To remove the rac flex cable
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B40/B20 Patient Monitor
-
Remove the three screws, then remove off the
board
-
Remove the paper from the recorder
-
Remove 2 screws inside the recorder
To disassemble the recorder
Reassemble the module in reverse order.
6-16
Document no. 2081505-001
Disassembly
2.8 Handling and storage of display component
Handling of display component and protective window
If the Display component surface becomes dusty, wipe it gently with absorbent cotton,
chamois or other soft material. If necessary, breathe onto the display surface and wipe
immediately. The display surface may also be cleaned using a small amount of normal hexane.
Do not use acetone, toluene or alcohol because they cause chemical damage to the polarizer.
1.
Wipe off saliva and water drops as soon as possible. Their prolonged contact with the
polarizer cause deformations and color fading.
2.
Do not open the component case because internal circuits are sensitive to electrostatic
discharges.
Placing a spare part Display component or a display shield into use:
Peel off the protective film slowly (in more than 10 seconds) from the display or protective
window surface. Fast peeling may generate enough static electricity to destroy the Display
component.
Storaging an display component as a spare part for a long period
1.
Store the display in a dark place. Do not expose it to sunlight or fluorescent light. Keep the
temperature between -30 °C and 85 °C / -22 °F and 185 °F at 5% to 95% humidity.
2.
The polarizer surface should not come into contact with any other object. It is
recommended that the display unit is stored in the container in which it was originally
shipped.
2.9 To replace the fuses
Pull out the fuse holder under the mains connector at the back of the monitor. Replace the
fuses with fuses of exactly the same type and rating.
To change the fuses
-
Use the screwdraft to press the fuse
holder
-
Prize and pull the holder out
-
Replace the fuse with correct type and
rating
2.10 To download the software
Refer to the instruction in Software’s FRU, follow the instruction for downloading service
software.
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7 E-miniC Module
Product overview
1
Product overview
1.1 Introduction
This chapter provides information for the maintenance and service of the E-miniC module. The
module is a single-width plug-in module designed for use with the GE modular monitors.
The E-miniC module provides airway measurements.
Letter C in the module name stands for CO2.
NOTE: E-miniC is intended for patients weighing over 5kg (11lb).
2
3
1
4
Figure 1
Airway gases setup with E-MiniC Module
1.
Module for measuring airway gases
2.
Anesthesia gas sampling line
3.
Airway adapter with sampling line connector
4.
Sampling line connector
Monitor software compatibility
The E-miniC module, is designed for use with VSP-B or later versions respectively.
Equipment safety symbols
-
When displayed on the E-miniC module, indicates that airway gases should
be calibrated every six months in normal use and every two months in
continuous use.
1.2 Measurement principle
1.2.1 CO2 measurement
E-MiniC is a side stream gas analyzer, measuring real time concentrations of CO2. It is a non
dispersive infrared analyzer that measures absorption of the gas sample using an optical
narrow band filter.
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The infrared radiation detector is thermopile.
Concentration of CO2 is calculated from absorption measured at 4.2 to 4.3 μm.
Figure 2
Absorbance of CO2
1.3 Main components
−
Gas sampling system
−
MiniC measuring unit
−
CPU board
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Product overview
1.3.1 Gas sampling system
The sampling system draws a gas sample to the analyzer at a fixed rate.
The gas sampling system samples the measured air to the module, and removes water and
impurities from it. A sampling line is connected to the water trap. The pump draws gas through
the sampling line to the gas measuring unit. After the measurement, the gas is exhausted from
the sample gas out connector.
The sample flow is nominally 150 ml/min.
Figure 3
MiniC block diagram
Mini D-fendTM
The sample is drawn through the sampling line. The gas then enters the module through the
water trap, where it is divided into two flows, a main flow and a side flow. The main flow goes
into the analyzer. This flow is separated from the patient side by a hydrophobic filter. The side
flow creates a slight subatmospheric pressure within the Mini D-fend water trap which causes
fluid removed by the hydrophobic filter to collect in the bottle.
Zero valve
The main flow passes through a magnetic valve before proceeding to the analyzer. This valve is
activated to establish the zero point for the MiniC measuring unit. When the valve is activated,
room air is drawn through a filter into the internal system and the gas sensor.
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NafionTM tube 1)
A Nafion tube is used between the water trap and the zero valve to balance the sample gas
humidity with that of ambient air. The tube prevents errors caused by the effect of water vapor
on gas partial pressure when humid gases are measured after calibration with dry gases.
Gas analyzers
After the zero valve and Nafion tube, the gas passes through the miniC sensor.
Sample flow differential pressure transducer
The sample flow differential pressure transducer measures pressure drop across a restrictor
and calculates the sample flow from the pressure difference.
Working pressure transducer
The working pressure transducer measures differential pressure between the tubing and
ambient air near the miniC sensor. The following messages are based on the obtained pressure
values: ‘Sample line blocked’, ‘Check D-fend’, ‘Replace D-fend’, and ‘Check sample gas outlet’.
Absolute pressure transducer
The absolute pressure transducer measures real-time ambient pressure.
Sampling pump
The gas sampling pump is a membrane pump run by a DC-motor. Sample flow is measured
with a differential pressure transducer across a known restriction. The motor is automatically
controlled to maintain a constant flow even when the D-fend water trap ages and starts to get
occluded. It also enables the use of sample tubes with varying lengths and diameters.
NOTE: In no occasion is the flow reversed towards the patient.
Side flow
Main flow
Mini
D-fend
Filter
Room air
Sample line
Zero
valve
MiniC
Diff.
Pressure
Sensor
Abs.
Pressure
Sensor
Pump
Gas out
Figure 4
1.
1)
Gas tubing layout
Nafion is a trademark of Perma Pure Inc.
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minic_fem_gastubing.vsd
Diff.
Pressure
Sensor
Product overview
1.3.2 MiniC sensor
The miniC sensor is a non-dispersive infrared analyzer measuring absorption of the gas sample
at 4.2 to 4.3 μm infrared wavelength, which is selected using an optical narrow band filter. The
IR lamp is a filament surrounded by thermal isolation. There is a hole in the isolation, passing
the radiation to a conical measuring chamber with 3 mm length. From the sample chamber,
the radiation goes into a thermopile detector with an optical filter in front of it.
The temperature sensor measures the miniC measuring unit's temperature and it is used for
temperature compensation.
The miniC sensor is connected to the CPU board and they can’t be replaced separately.
Figure 5
MiniC sensor
1.3.3 CPU board
The CPU board contains a processor, memories and all the analog signal processing needed. A
MiniC measuring unit is attached to the board with a flexible PCB. Also supply voltage and an
RS485 serial channel are connected to the CPU board using another flexible PCB.
Analog signals (CO2, temperature, absolute and differential pressures and lamp current signals)
are fed to the 16-bit A/D converter. The processor controls the A/D converter and calculates
the CO2 percentage and respiration rate from this data.
The processor controls sample flow by adjusting the pump voltage based on the differential
pressure signal. The processor also controls the current of the IR source and keeps it constant.
Calibration data is stored on the EEPROM.
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1.4 Connectors and signals
Table 1
Module bus connector pin description
Module bus connector
13
25
1
14
Pin No.
I/O
Signal
1
I
RESET RS485
2
I
-15 VDC (not used)
3
I
+15 VDIRTY
4
I
+15VDC (not used)
5
I/O
-DATA RS485
6
I/O
DATA RS485
7
8
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Ground and Shield
I
-RESET RS485
9
n/c
10
n/c
11
n/c
12
n/c
13
Ground and Shield
14
I
+24/+32 VDIRTY depends on power supply (not
used)
15
I
Ground DIRTY
16
n/c
17
n/c
18
n/c
19
n/c
20
I
GASFR (not used)
21
I
CTSD (not used)
22
I
TXDD (not used)
23
O
RXDD (not used)
24
I
+5 VDC (not used)
25
I
+5 VDC DIRTY (not used)
Maintenance and checkout
2
Maintenance and checkout
To help ensure the equipment remains in proper operational and functional order, adhere to a
good maintenance schedule.
Corrective maintenance
Service personnel should perform the following checkout procedure after any corrective
maintenance, before taking the module back into clinical use:
Performed service activity
Required checkout procedure
Visual inspections
Functional check
Front cover replaced
All steps
Not applicable
Mini D-fend O-rings
All steps
Check "Gas sampling system
leak test" and "Sample flow
check"
Module casing opened either
for troubleshooting purpose
or for replacing any of the
internal parts.
All steps
All steps
Planned maintenance
Service personnel shall perform the following checkout procedure completely every 12 months
after installation:
1.
"Replacement of planned maintenance parts"
2.
"Visual inspections"
3.
"Functional checkout"
The instructions include a check form ("APPENDIX D") which should be filled in when performing
the procedures.
The symbol

in the instructions means that the check form should be signed after
performing the procedure.
2.1 Replacement of planned maintenance parts
2.1.1 Required parts
Replace the following parts that wear in use at the recommended interval.
Part Number
Description
Pieces
Replacement
interval
733382-HEL
Nafion Tube
1
Once a year
656565
Mini D-fendTM O-ring
2
Once a year
M1011471
Zero valve air filter
1
Once every 3 years
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It is also recommended to replace the Mini D-fend water trap and the gas sampling line as part
of the planned maintenance procedure.
NOTE: See the supplies and accessories document delivered with the manual for compatible
accessories.
2.1.2 Replacement procedure
Replace the specified planned maintenance parts according to the following procedure. Refer
to “5. Disassembly and reassembly” for more information.
1.
Replace the zero valve air filter once every 3 years.
•
•
Use a small flat blade screwdriver to pull the old zero line air filter.
Attach a new zero line air filter into place.
Zero line air filter
2.
Nafion tube
Replace the special tube (Nafion) and check the condition of the internal tubing.
•
Replace the 300 mm nafion tube in the sample gas line between the Mini D-fend
water trap and the zero valve unit.
•
Check that the tubing inside the module is not contaminated. Any contamination
inside the tubing may indicate that the valve or sensor is contaminated too. This can
increase a risk of faulty operation in valve or sensor. The gas sensor is not possible
to clean in the field. Therefore, replace the whole miniC assembly with a new one.
NOTE: The nafion tube do not include the silicon fittings they connect to. Use the original silicon
fittings unless they are not damaged or leaking.
3.
Replace the Mini D-fend O-rings:
•
•
Detach the Mini D-fend.
•
Set the new rubber O-rings into place and attach a new Mini D-fend.
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Detach the old rubber O-rings that are around the metal Mini D-fend connectors e.g.
using a small flat blade screwdriver. Pay special attention not to scratch the metal
Mini D-fend connectors and thus causing leaking.
Maintenance and checkout
2.2 Visual inspections
Detach the module from the module slot and check that:
•
•
•
•
•
the front cover panel is intact
all connectors are intact and attached properly.
the module box and latch are intact
the metal D-fend connectors and the D-fend O-rings are clean and intact
the module and the applied parts are clean
The cleaning precautions, cleaning requirements, cleaning procedures, and recommended
cleaning solutions for the monitor are described in the “B40 User’s Guide”. For details about
cleaning, disinfecting and sterilizing the accessories, see the instructions for use in the
accessory package.

2.3 Functional checkout
2.3.1 Test setup
Required tools
−
A barometer
−
A mass flowmeter for measuring air flow, minimum measurement range 100-300 ml/min,
accuracy 5% or better in the 100-300ml/min range.
−
P/N: 755534-HEL Calibration Gas Regulator
−
P/N M1006864 Calibration Gas Regulator, (US only)
−
P/N: 755580 Calibration gas 5% CO2 and air, package of 4 cans
−
P/N 755587 QUICK CAL calibration gas, (US only)
−
3 m / 10 ft gas sampling line
−
A pressure manometer with either an integrated or a separate pressure pump
NOTE: See the supplies and accessories document delivered with the manual for compatible
accessories.
Connections
Disconnect the module from the monitor, if connected.
Monitor configuration
1.
Configure the CO2 waveform field to the monitor screen.
2.
check the CO2 unit: Airway Gas > CO2 Setup > Unit, make sure the unit is mmHg.
2.3.2 Procedure
1.
Gas sampling system leak test
Check the gas sampling system for possible leakages.
•
•
Disconnect the module from the monitor.
Connect a new Mini D-fend water trap to the module.
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•
•
Connect a new gas sampling line to the sampling line connector in the water trap.
•
•
Block the "Sample Gas Out" connector.
•
Check that the pressure reading does not drop more than 6 mmHg during 1 minute.
Connect the other end of the gas sampling line to a pressure manometer and a
pressure pump.
Pump 100 mmHg ± 20 mmHg pressure to the gas sampling system. Let the pressure
stabilize for approximately 10 seconds.
NOTE: The gas module shall be disconnected from the monitor during the leak test.

2.
Sample flow check
Check the sample flow rate.
NOTE: Gas measurement is not available during the first 1 minute after the module is
connected due to warm-up. Message 'Calibrating gas sensor' is shown in the waveform field.
Wait until warm-up is completed before proceeding with the next steps.
•
•
•
•
Connect the module with the gas sampling line to the monitor.
Connect the gas sampling line to the sampling line connector in the water trap.
Connect the other end of the gas sampling line to a flowmeter.
Check the sample flow rate reading from the flowmeter. The flow rate shall be within
the specification limit 150 ± 25 ml/min.
NOTE: Readjustment is needed, if the measured value is not within the specification limits.
Adjust the sample gas flow rate according to the instructions in section “3.1. Sample flow rate
adjustment”.
NOTE: If the sampling pump is noisy it indicates possible problems with motor bearing. In this
case it is recommended to replace the noisy sampling pump with a new one.

3.
Zero valve operation
Test the zero valve functionality.
•
•
Connect the gas regulator to the calibration gas container.
•
Enter to gas service menu: select Monitor Setup > Install/Service (16-4-34) >
Service (26-23-8) > Parameters > Gas Unit > Gases.
•
•
•
•
Start feeding calibration gas. Wait until the CO2 value rises to approximately 5%.
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Connect the end of the gas sampling line to the regulator on the gas container.
Leave the regulator overflow port open to room air.
Open the zero valve to room air by selecting Zero valve ctrl.
Check that the CO2 values drop back near 0%.
Stop feeding the calibration gas.
Maintenance and checkout
•
Turn the zero valve back to the normal measurement position by selecting ZERO to
MEAS.

4.
Gas calibration
Perform gas calibration according to the instructions in section “3.2. Gas calibration”.

5.
Ambient pressure
Use a barometer to check the operation of the absolute pressure sensor.
•
Check that the ambient pressure value shown in the Gas service menu does not
differ more than ± 13.33 mbar from the value shown by the barometer.

6.
Occlusion detection
•
•
Block the tip of the sampling line by your finger.
Check that message 'Sample line blocked' appears to the parameter window within
30 seconds.

7.
Air leak detection
•
•
Detach the Mini D-fend water trap.
Check that message 'Check D-Fend' appears to the parameter window within 30
seconds.

8.
Airway gases
•
•
Breathe a minimum of 5 times to the tip of the sampling line.
Check that a normal CO2 waveform appears to the waveform field and the EtCO2
and FiCO2 values are updated to the parameter window.

9.
Apnea detection
•
•
Stop breathing to the gas sampling line.
Check that an 'Apnea' alarm appears to the message field within 30 seconds.

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2.3.3 Test completion
•
Fill in all necessary documents.
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Calibration and adjustments
3
Calibration and adjustments
3.1 Sample flow rate adjustment
Sample flow rate shall be adjusted:
•
if the sample flow rate check in section “2.3. Functional checkout” failed.
3.1.1 Calibration setup
Required tools
−
A mass flowmeter for measuring air flow, minimum measurement range 100-300 ml/min,
accuracy 5% or better in the 100-300 ml/min range.
−
3 m / 10 ft Gas sampling line
NOTE: See the supplies and accessories document delivered with the manual for compatible
accessories
NOTE: Use only accurate, properly maintained, calibrated and traceable calibration tools for
the parameter calibration to ensure measurement accuracy.
NOTE: Refer to the flowmeter documentation for user instructions.
Connections
• Ensure that the module is connected to the monitor.
• Ensure that you have a new Mini D-fend water trap in use.
• Connect a new gas sampling line to the sampling line connector in the water trap.
• Connect the other end of the gas sampling line to the flow meter.
NOTE: Before checking or adjusting the sample flow rate, make sure there is no leakage in the
sampling system.
3.1.2 Sample flow rate adjustment
1.
Enter to gas service menu: select Monitor Setup > Install/Service (16-4-34) > Service
(26-23-8) > Parameters > Gas Unit > Gases.
2.
Select Sample gain adj
3.
Adjust the sample flow to the nominal value 150 ml/min by using the Trim knob to scroll
gain value up-down:
•
To decrease the sample flow rate measured by the flow meter by approximately 7.5
ml/min, add gain value by 0.05.
•
To increase the sample flow rate measured by the flow meter by approximately 7.5
ml/min, lower the gain value by 0.05.
4.
Press Trim Knob to confirm the gain adjustment. Wait until the sample flow value shown
returns near to the nominal value 150 ml/min and then check the actual measured flow
rate from the flow meter.
5.
Repeat steps 3 and 4 until the flow meter shows a 150 ± 25 ml/min flow rate.
NOTE: Adjust the flow rate according to the reading in the flow meter. The flow rate reading in
the Gases menu is measured by the internal electronics and settles always back to the nominal
150 ml /min independent on the real flow rate.
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3.2 Gas calibration
Gas calibration shall be performed:
•
•
each time planned maintenance is performed.
each time corrective maintenance is performed.
NOTE: Gas calibration is a normal user action. Refer to the monitor user’s guide for the
recommendation for gas calibration interval in clinical use.
3.2.1 Calibration setup
Required tools
−
P/N: 755534-HEL Calibration Gas Regulator
−
P/N M1006864 Calibration Gas Regulator, (US only)
−
P/N: 755580 Calibration gas 5% CO2 and air, package of 4 cans
−
3 m / 10 ft Gas sampling line
−
P/N 755587 QUICK CAL calibration gas, (US only)
NOTE: See the supplies and accessories document delivered with the manual for compatible
accessories.
NOTE: Use only the specified GE Healthcare calibration gas for the gas calibration to ensure
measurement accuracy. Do not use any other calibration gases. Check the calibration gas
container's labelling to ensure that the calibration gas has not expired.
NOTE: Ensure that the gas regulator is functioning properly before gas calibration. Refer to the
gas regulator's "Instructions for Use" letter for the annual maintenance instructions.
Connections
1.
Ensure that the module is connected to the monitor.
2.
Ensure that you have a new Mini D-fend water trap in use.
3.
Connect the gas regulator to the calibration gas container.
4.
Connect a new gas sampling line to the sampling line connector in the water trap.
5.
Connect the other end of the gas sampling line to the regulator on the gas container.
Leave the regulator overflow port open to room air.
Figure 6
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Connecting a gas regulator to the calibration gas container and
connecting a sampling line to the gas regulator.
Calibration and adjustments
3.2.2 Procedure
NOTE: Gas calibration is not available during the first 5 minutes after the module is connected.
For maximum accuracy, let the monitor to warm up for 30 minutes before starting calibration.
NOTE: Gas calibration is not available during a 'Sample line blocked', 'Check D-Fend' and
'Check sample gas out’ alarm condition. Resolve the alarm condition before starting
calibration.
1.
Enter to gas calibration menu: Airway Gas > Gas Calibration
2.
The monitor will start automatic zeroing of the gas sensors. Wait until the message
'Zeroing' is replaced by a message 'Zero OK' message.
3.
Open the regulator after a message 'Feed gas' is shown. The measured gas
concentrations are shown in real-time in the gas calibration menu.
Continue feeding the calibration gas until the measured gas concentrations are stabilized
and a message 'Adjust' is shown. Close the regulator.
4.
Use the Trim Knob to adjust the gas readings shown in the Calibration menu to match
with the gas readings in the labelling of the calibration gas container. Press Trim Knob to
accept the adjusted values when the gas readings match each other.
5.
Wait until a message 'Ok' is shown. NOTE: A message 'Zero error' is shown in case the
zeroing fails.
NOTE: A message 'Calibr.error' is shown, if you do not start feeding gas within 1 minute after
the automatic zeroing is completed, or if the calibration fails due to too large gain adjustment.
NOTE: If zeroing or calibration failed, select the Recalibrate to restart the calibration procedure
from the beginning.
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4
Troubleshooting
The problems and solutions in this chapter represent only a few of the faults that you may
encounter and are not intended to cover every possible problem that may occur.
This chapter focuses on troubleshooting technical problems. For clinical and operation issues
refer to the "User’s Guide" for troubleshooting.
NOTE: Perform the checkout procedure described in chapter “2. Maintenance and checkout”
each time after you have opened the module casing.
If the problem remains, call technical support for service. To ensure accurate problem solving,
please be prepared to provide the following information:
•
•
•
•
Problem description and the troubleshooting done so far.
Device information.
Error messages displayed, if any.
Other information, as requested.
4.1 Visual inspection
Before beginning any detailed troubleshooting, complete thorough visual inspection to be sure
that:
•
•
•
•
•
•
the front cover is intact
•
•
Check that the module in doubt is compatible with the monitor.
the water trap connection and disconnection functions properly
all connectors are intact, clean and are attached properly
the module box and latch are intact
the metal D-fend connectors and the D-fend O-rings are clean and intact
Check if there are any messages shown in the message field. Find the possible cause and
solution from the “Messages” section in "User’s Guide" .
Check to the accessories used with the module. If in doubt, replace the accessories with
known good ones.
If in doubt of having any loose parts or cable connections inside the module, detach the
module box by removing the four screws from the back of the module and check that:
•
•
•
•
•
all screws are tightened properly
all cables are connected properly
tubes are not pinched and there are no sharp bends on them
all tubes are connected properly
there are no loose objects inside the module
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Troubleshooting
4.2 Troubleshooting checklist
The following simple troubleshooting hints may help you to localize and isolate a functional
problem to the correct unit. Ensure that the monitor is turned on and the module is connected.
4.2.1 Gas sampling system troubleshooting
•
Faults which can occur in the sampling system are: leaks or blockages in the tubing,
failure of the sampling pump or the magnetic valves, or diminishing of the flow rates
because of dirt or other matter accumulating in the internal tubing.
•
Whenever suspecting the sampling system and always after having done any work on
the sampling system, check the sampling system for leakages and check the flow rate.
•
The D-fend Pro water trap should be replaced, when the 'Replace D-Fend' message
appears.
•
If any liquid has entered the IR sensor due to water trap filter failure, contact GE
Healthcare service.
•
If the sampling pump is noisy it indicates possible problems with motor bearing. In this
case it is recommended to replace the noisy sampling pump with a new one.
•
Check that the tubing inside the module is not contaminated. Any contamination inside
the tubing may indicate that the valve or sensor is contaminated, too. This can increase a
risk of faulty operation in valve or sensor. The gas sensor is not possible to clean in the
field. Therefore, replace the whole miniCO2 assembly with a new one.
NOTE: All internal tubes are mechanically fragile. Sharp bends may cause leaks and occlusions.
4.2.2 MiniC sensor troubleshooting
•
The CPU contains factory calibration data for the miniC sensor. Thus, they can't be
replaced separately in the field. In case of failure, the complete miniCO2 assembly should
be replaced.
If the problem remains, contact service.
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4.3 Troubleshooting charts
Problem
Cause
What to do
too low ETCO2 value
• sudden decrease in circulation
• pulmonary embolism
• hyperventilation
• very large dead-space
• large shunting
• leak in sampling system
• calibration error
• high by-pass flow from ventilator
• check all connections
• check calibration
too high ETCO2
• hypoventilation
• increased metabolism
• D-fend contaminated
• calibration error
• change D-fend
• check calibration
waveform clipped
• incorrect scaling
• change scale
no response to breathing
• apnea
• (disconnection)
• sampling line or water trap loose or
• check all connections
blocked (air leak)
ETCO2 over scale >20%
Shown until 32%,
specified range 0...20%
ETCO2>PaCO2
• sample gas outlet blocked
• check that outlet is open
• abnormally high ETCO2 (permissive
• let the module run without a
hypercapnia)
• CO2 sensor contaminated
• D-fend malfunction
sampling line until the CO2
sensor has dried out
• change D-fend
• unit is mmHg or kPa and ETCO2 is close to • change to “wet gas” by using
arterial PCO2
install/service menu
• “dry gas” as default
Abnormally high (or low)
response to CO2, or
sudden occlusion
message.
• Pressure transducer failure.
Unable to perform gas
calibration.
• Gas calibration is not available during the • Wait until warm-up is
first 5 minute after the module is
connected.
• Gas calibration is not available during
‘Sample line blocked’, ‘Check D-fend’, and
‘Check sample gas out’ alarm condition.
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• Replace miniCO2 assembly.
completed.
• Resolve the alarm condition
before starting calibration.
Disassembly and reassembly
5
Disassembly and reassembly
5.1 Disassembly guidelines
Field service of the module is limited to replacing the serviceable parts listed below (see also
chapter “6. Service parts”). Attempting a field repair on any other parts could jeopardize the
safe and effective operation of the module, and void the warranty.
NOTE: Only a qualified service technician should perform field replacement procedures.
NOTE: Perform the checkout procedure described in chapter “2. Maintenance and checkout”
after you have disassembled and reassembled the module.
5.1.1 Serviceable parts
•
The miniCO2 assembly, including the following components (CPU board, mini CO2 sensor,
pump unit, tubing unit and zero valve and pressure transducers)
•
•
•
•
•
•
•
•
tubing unit
pump unit
zero valve
air filter
Mini D-fend O-rings
Nafion tube
Mini D-fend
mechanical parts listed in the service parts chapter
5.1.2 Service limitations
The following parts are not serviceable:
•
miniC sensor and CPU board can't be replaced separately.
NOTE: The CPU contains factory calibration data for the miniC sensor. In case of failure, the
complete miniCO2 assembly should be replaced. Attempts to repair or calibrate the unit
elsewhere will adversely affect operation of the unit. The information provided in this document
is for reference only.
5.1.3 ESD precautions
All external connectors of the module are designed with protection from ESD damage.
However, if the module requires service, exposed components and assemblies inside are
susceptible to ESD damage. This includes human hands, non-ESD protected work stations or
improperly grounded test equipment. The following guidelines may not guarantee a 100%
static-free workstation, but can greatly reduce the potential for failure of any electronic
assemblies being serviced:
•
Discharge any static charge you may have built up before handling semiconductors or
assemblies containing semiconductors.
•
A grounded, antistatic wristband or heel strap should be worn at all times while handling
or repairing assemblies containing semiconductors.
•
Use properly grounded test equipment.
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Document no. 2081505-001
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•
Use a static-free work surface while handling or working on assemblies containing
semiconductors.
•
Do not remove semiconductors or assemblies containing semiconductors from antistatic
containers until absolutely necessary.
•
•
•
Do not slide semiconductors or electrical/electronic assemblies across any surface.
•
•
Handle all PCB assemblies by their edges.
Do not touch semiconductor leads unless absolutely necessary.
Semiconductors and electronic assemblies should be stored only in antistatic bags or
boxes.
Do not flex or twist a circuit board.
5.1.4 Before disassembly
•
Note the positions of any sampling tubes, wires or cables. Mark them if necessary to
ensure that they are reassembled correctly.
•
Save and set aside all hardware for reassembly.
5.1.5 Tools needed
-
pozidrive screwdrivers
-
flat blade screwdriver
-
pincers
-
antistatic wristband
5.2 Disassembly and reassembly procedure
Disassembling the airway module (see the exploded view of the module in chapter “6. Service
parts”:
1.
Remove the two screws from the back of the module.
2.
While pressing the release latch, pull the module box slowly backwards and remove it
from the main body.
To reassemble the module, reverse the order of the disassembly steps.
Check that:
•
•
•
•
•
all screws are tightened properly
all cables are connected properly
tubes are not pinched and there are no sharp ends on them
all tubes are connected properly
there are no loose objects inside the module
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Document no. 2081505-001
Disassembly and reassembly
5.2.1 Replacing the pump unit
1.
Detach the front cover of the module by releasing the snaps that hold the front cover to
he front chassis unit by using a small flat blade screwdriver. There are 2 snaps on both
sides of the module and 1 snap on the top.
2.
Remove the module casing
3.
Unplug the two tubes from the back of the front chassis.
4.
Detach the front chassis from the metal frame by removing the two screws.
5.
Unplug the hose of the pump.
6.
Disconnect the pump’s cable from the CPU board.
7.
Remove the three screws that connect the pump unit to the board.
To reassemble the module, reverse the order of the dissassembly steps.
Figure 7
Uncovered E-miniC module
5.2.2 Replacing the miniCO2 assembly
1.
Detach the front cover of the module by releasing the snaps that hold the front cover to
he front chassis unit by using a small flat blade screwdriver. There are 2 snaps on both
sides of the module and 1 snap on the top.
2.
Remove the module casing
3.
Unplug the two tubes from the back of the front chassis.
4.
Detach the front chassis from the metal frame by removing the two screws.
5.
Detach the miniCO2 assy from the frame plate by removing the three screws.
6.
Disconnect the FM board from the miniCO2 assy.
To reassemble the module, reverse the order of the dissassembly steps.
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6
Service parts
6.1 Ordering parts
To order parts, Contact GE Healthcare. Contact information is available at
www.gehealthcare.com. Make sure you have all necessary information at hand.
NOTE: Perform the checkout procedure described in chapter “2. Maintenance and checkout”
after you have disassembled and reassembled the module.
6.2 Spare parts for E-miniC
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Document no. 2081505-001
Service parts
Item
Description
Order No.
Mini D-fend, pkg of 10 pcs
8002174
-
MiniCO2 assembly, including the following components (CPU board, mini
CO2 sensor, pump unit, tubing unit and zero valve and pressure
transducers)
M1013204
1
Module Casing, Single
M1021035
2
Front Chassis Unit, E-miniC
M1027134
3
M-miniCO2, CONNECTOR FOR D-FEND, MINI CO2
8002173
4
O-RING, O-RING, 2.5x1.6, VITON, SHORE70, BLACK
656565
5
Front Cover, USA, E-miniC
M1026941
5
Front Cover, E-miniC
M1026943
6
Latch
M1021039
7
Torsion Spring
M1020935
8
Screw-cross rec. c/s h, stzn, m3x6
*
* Part is not available from GE. Source locally.
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Item
Description
Order No.
9
Metal frame
879184
10
Frame, E-miniC
M1024360
11
Nafion tubing 300 mm
733382-HEL
12
MAGN-VALVE, N.O. valve, 3/2, 5VDC, 0.55W, includes seal
585714
13
Module Connection Flex, E-miniC
M1027744
14
Cross cylinder head screw M3x6
*
15
Pump Unit for miniC
M1013716
15
Air filter, M-MiniC
M1011471
17
Tubing Unit for miniC
M1013717
18
Cross cylinder head screw M3x10
*
19
Screw-cross rec.c/s h,m3x8,acidproof
*
* Part is not available from GE. Source locally.
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Document no. 2081505-001
8 E-sCO, E-sCAiO and
N-CAiO Modules
Product overview
1
Product overview
1.1 Introduction
This document provides information for the maintenance and service of the E-sCO, E-sCAiO,
N-CAiO modules. These modules are single width plug-in modules.
The modules provide airway measurements. Letters in the module name stand for:
C = CO2 and N2O, O = patient O2, A = anesthetic agents, and i = agent identification
Table 1
Options for E-sCO, E-sCAiO and N-CAiO modules
Modules Parameters / measurements
CO2
N2O
O2
E-sCO
X
X
X
E-sCAiO
X
X
X
X
X
X
N-CAiO
X
X
X
X
X
X
Figure 1
(1)
Anesthetic Agent ID
agents
Additional measurements
MAC
MACage Balance
gas
Respiration
rate
X
X
X
X
X
Airway gases measurement setup
E-sCO, E-sCAiO or N-CAiO module
(2)
Gas sample, gas sampling line connector on the water trap
(3)
Gas sampling line
(4)
Gas sampling line connector on the airway adapter; place the connector upwards
(5)
Airway adapter with sampling line connector
(6)
Heat and moisture exchanger with filter (HMEF) (optional)
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1.2 Measurement principle
1.2.1 CO2, N2O, and agent measurement
MiniTPX is a side stream gas analyzer, measuring real time concentrations of CO2, N2O, and
anesthetic agents (Halothane, Enflurane, Isoflurane, Desflurane, and Sevoflurane).
Figure 2
MiniTPX sensor principle
Anesthetic agents or mixtures of two anesthetic agents are automatically identified, and
concentrations of the identified agents are measured. MiniTPX also detects mixtures of more
than two agents and issues an alarm.
MiniTPX is a non-dispersive infrared analyzer, measuring absorption of the gas sample at
seven infrared wavelengths, which are selected using optical narrow band filters.
The infrared radiation detectors are thermopiles.
Concentrations of CO2 and N2O are calculated from absorption measured at 3-5 μm.
Figure 3
Absorbance of N2O and CO2
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Product overview
Identification of anesthetic agents and calculation of their concentrations is performed by
measuring absorptions at five wavelengths in the 8-9μm band and solving the concentrations
from a set of equations.
Figure 4
Infrared absorbance of AAs
The measuring accuracy is achieved utilizing numerous software compensations. The
compensation parameters are determined individually for each MiniTPX during the factory
calibration.
1.2.2 O2 measurement
The differential oxygen measuring unit uses the paramagnetic principle in a pneumatic bridge
configuration. The signal picked up with a differential pressure transducer unit is generated in
a measuring cell with a strong magnetic field that is switched on and off at a main frequency of
164 Hz. The output signal is a DC voltage proportional to the O2 concentration difference
between the gas to be measured and the air reference.
Figure 5
O2 measurement principle
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1.3 Main components
The respiratory modules consist of:
•
•
•
•
Gas sampling system
MiniTPX measuring unit
MiniOM measuring unit
CPU board
1.3.1 Controls and connectors
1
2
3
4
Figure 6
E-sCAiO, E-sCO, N-CAiO modules
(1)
D-fend Pro water trap
(2)
Gas sample, sampling line connector on the water trap
(3)
Water trap container
(4)
Gas exhaust, connector for the gas exhaust line (sampling gas out)
Connector
Module
Description
D25 connector
all modules
Module bus connector
1.3.2 Gas sampling system
The gas sampling system draws a 120 ml/min sample from the patient's airway to the module.
The sampling system also takes a 30 ml/min flow of room air to the oxygen sensor. When the
gas sensors are zeroed, room air is taken through the CO2-absorber to the gas sensors instead
of the sampled gas from the patient's breathing.
The gas sampling line is connected between the patient circuit and the Gas Sample port on the
water trap. The water trap protects the sampling system and gas sensors from liquids and
dust.
The diagram of the gas sampling system is shown in the figure below:
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Product overview
Figure 7
Gas sampling system
The sampling system has a self diagnostics that detects disturbances in the gas flow, reveals
the most common reasons for disturbances, such as occluded sampling line or blocked gas
exhaust line, and communicates relevant status messages to the patient monitor.
The system is designed so that gas the sampled gas will not flow from the sampling line back to
the patient circuit. The parts and connections of the sampling system are streamlined for
minimal dead spaces and turbulences in gas flows.
All gas inputs of the module have dust filters protecting the sampling system and gas sensors.
The water trap acts as a dust filter for the sampled gas and the module should always have the
water trap connected.
NOTE: It is very important to prevent dust from entering the open gas connections during
service operations.
D-fend Pro(+) water trap
The gas sampling line is connected to the input of the water trap where a special membrane
passes gases and vapors but stops liquids. The gas flowing through the membrane continues
via the main flow connector of the water trap to the module. The main flow is about 90% of the
sample flow.
Liquids stopped below the membrane are moved to the water container by a side flow that
goes through the water container and the water separation membrane before entering the
side flow connector of the water trap. Thus, the side flow also is free of liquids when it gets into
the module. In the module, the side flow is connected directly to the pump input and it does not
enter the gas sensors.
NOTE: The water trap acts as a dust filter for the sampling system and gas sensors. Thus, the
module should always have the water trap connected.
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Zero valve and CO2 absorber
The zero valve is activated during gas sensor zeroing. Room air is drawn through the
CO2-absorber and the zero valve to the gas sensors, and the main flow of sample gas is
stopped. The zero gas comes to the sensors through the CO2-absorber that chemically absorbs
CO2. The side flow of the water trap flows in the gas sampling line even during zeroing.
During normal monitoring, the zero valve is not activated and the sampled gas gets through
the zero valve to the gas sensors.
Figure 8
Absorber
Nafion tubes 1
The Nafion tube between the water trap and the zero valve equalizes the humidity of the
sampled gas to ambient level. This will prevent calibration errors caused by the difference in
humilities in the sampled breathing gas and the totally dry calibration gas.
Another Nafion tube is used between the CO2 absorber and the zero valve to prevent
condensation of water generated in the CO2 absorber as by-product of CO2-absorption.
Gas sensors
After the zero valve, the gas flows trough the MiniTPX sensor that measures the concentrations
of all gases but oxygen.
The oxygen concentration is measured in the MiniOM sensor that has two inputs. One input
draws in a part of the main flow and the other draws in room air as reference gas for the O2
measurement.
Sample flow differential pressure transducer
The module measures total flow at the input of the gas pump and reference flow at the OM
reference line. The sample flow is the difference of these two flows.
Working pressure transducer
The working pressure transducer measures absolute working pressure between the MiniTPX
unit and MiniOM unit. It is used for messages: ‘Sample line blocked’, ‘Check D-fend’, ‘Replace
D-fend’ and ‘Check sample gas out’.
Pneumatics unit
The pneumatics unit contains the zero valve, the occlusion valve and the pneumatics block
with tubing connections.
1
Nafion is a registered trademark of Perma Pure Inc.
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Product overview
The zero valve is activated during the zero level calibrations of gas sensors. The occlusion valve
is activated when the sampling line or water trap is occluded. With the activated occlusion
valve, the gas pump generates maximal suction trough the “side flow” connector of the water
trap, thus maximizing the transfer of liquids from the wet side of the water trap to the
container.
The pneumatics block contains a network of constrictions to divide the sampled gas in correct
proportions to different parts in the module. The first branching takes place in the water trap
where incoming flow is divided to the “main flow” and “side flow”. The second branching takes
place before the MiniOM sensor.
The pneumatics block also contains a pneumatic low pass filter between gas sensors and gas
pump. The filter consists of constrictions (resistors) and volumes (capacitors) and it attenuates
the pressure pulsation generated in the gas pump so that they do not disturb the operation of
the gas sensors.
Gas pump unit
The gas pump is a membrane pump run by a brushless DC-motor. The pump is adjusted so
that the sample gas flow is kept close to its nominal value even when the flow resistances in
the sampling line of water trap change.
The pump is in a plastic enclosure to minimize the operating noise and mechanical vibration of
the pump unit. A pneumatic damping chamber is integrated to enclosure to attenuate the
pressure pulsation and noise conducted to the gas exhaust port.
Pressure measurements
The four pressure sensors on the CPU board are used to measure ambient pressure, working
pressure of the MiniTPX and MiniOM sensors and pressure of the reference gas flow to the
MiniOM sensor.
Sample flow control
The gas flow in the sampling line is monitored by measuring the gas flow at the input of the gas
pump and the reference flow to the oxygen sensor is estimated by measuring the pressure in
the reference gas flow branch. The sample flow is calculated by subtracting the reference flow
from the total gas flow. A control loop adjusts the rotation speed of the pump motor so that the
gas flow is kept close to 120 ml/min.
Gas sampling self-diagnostics
The sample flow and the vacuum in the sampling system are used for continuous monitoring
of the gas sampling system. The vacuum is calculated in real time as difference of the
measured ambient and working pressures.
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The self-diagnostics of the gas sampling system sends the following status data to the patient
monitor when specific triggering conditions are met: ‘Check D-Fend’, ‘Sample line blocked’,
‘Replace D-Fend’, ‘Check sample gas out’ and ‘Continuous blockage’.
The gas pump is stopped when the 'Sample line blocked' has lasted for more than 1 minute.
The module automatically restarts the pump to check whether the abnormal situation has
been resolved so that normal gas sampling operation is possible.
The gas pump repeats 1 minute full pump, 30 seconds pump off when the ‘Continuous
blockage’ message is shown.
Figure 9
Gas tubing layout
1.3.3 MiniTPX measuring unit
The MiniTPX unit is a non dispersive infrared analyzer, measuring the absorption of the gas
sample at seven infrared wavelengths, which are selected using optical narrow band filters.
The IR source is a micro-machined heating element with an integrated collimator. From the
output of the source, the radiation is passed to a flow optimized measuring chamber.
From the sample chamber, radiation goes via a specially designed beam splitter to two
detectors units, each with four thermopile detectors and integrated optical filters. The miniTPX
measuring unit has two CO2 channels for redundancy purposes. A more detailed description of
the measuring principle can be found in section “1.2.1. CO2, N2O, and agent measurement”.
Each detector unit also measures the unit's temperature. The module CPU uses it for further
processing and temperature compensation of the measured raw signals.
The miniTPX unit includes an amplifier board with the following functions:
•
•
On-board 5V regulator and 2.5V reference source.
•
•
PWM controlled power for the IR source.
Preamplifiers for the eight thermopile detectors and for the two temperature sensors. A
16 channel buffered multiplexer is used to transfer the signals to the CPU board.
An EEPROM memory for storing factory calibration coefficients of the sensor.
The input to the amplifier board comprises a 7V DC feed and CPU control signals for the PWM,
the multiplexer and the EEPROM. When the module starts up, the calibration coefficients are
read to the module CPU and then used for calculating the gas concentrations from the raw
data received from the sensor multiplexer.
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Product overview
Figure 10
MiniTPX measuring unit
1.3.4 MiniOM Oxygen sensor
The miniOM sensor measures the concentration of Oxygen in the gas sample.
The measurement is based on the magnetic properties of oxygen. The sensor measures the
sound pressure generated in the air gap of the magnet at the 164 Hz operating frequency. Two
microphones are used for detection and the Oxygen concentration is calculated from the RMS
value of the difference of the microphone outputs. The measurement principle is described in
more detail in section ”1.2.2. O2 measurement”.
The sensor consists of the following functional parts
•
•
•
•
Pneumatic system
Amplifier board
MiniOM board
Magnet
The sensor is shown in the picture below.
Figure 11
MiniOM oxygen sensor
NOTE: The sensor is assembled in the module using flexible suspension to prevent the
mechanical vibrations of the gas pump and cooling fan from disturbing the Oxygen
measurement. All gas lines to the sensor must also be carefully assembled so that they do not
pick up mechanical vibrations of the module mechanics.
Pneumatic System
The pneumatic system, together with the gas sampling system of the module creates the gas
flows and pressures needed for the oxygen measurement and protection of the microphones
from excessive pressure. About 30 ml/min flow of sampled gas comes to the In connector on
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the MiniOM sensor. Room air is drawn to the Ref input of MiniOM also at 30 ml/min rate. About
75% of these flows are conducted to a pressure equalization chamber so that only about a 8
ml/min flow of the two gas streams continue into the air gap of the magnet. All the internal gas
flows finally get to a volume enclosed by the sensor board and the sensor body, and then flow
out through the Out connection of the sensor. Some of the gas channels and flow restrictors
are integrated into the preamplifier electronics board utilizing the multi-layer structure of the
LTCC (Low Temperature Co-fired Ceramics) circuit board technology.
NOTE: It is very important to prevent dust or liquids from getting into the pneumatic circuit of
MiniOM and thus, the gas connections should always be closed with a protecting cap when the
sensor is not connected to the module pneumatics.
Amplifier Board
The amplifier board located in the sensor has two electric microphones for the differential
detection of pressure pulses generated in the magnet's air gap. The microphone signals are fed
to two identical signal conditioning channels with a band-pass filter and a digitally controlled
amplifier. The voltage gains of the amplifiers are set during factory calibration so that the
responses of the microphone channels match in spite of differences in microphone's
sensitivities. The amplifier board also has an amplifier for the thermistor measuring the
temperature of the magnet.
MiniOM Board
The MiniOM board has five functions
•
•
•
•
•
Drive the magnet coil.
Convert the microphone and temperature signals into digital format.
Filter digitally the microphone signals and perform the RMS-conversion.
Communicate digitally with the module CPU.
Store factory calibration data in permanent memory and communicate them to the
module CPU.
The module CPU provides the coil drive and communication enabling signals and also clock
signal for MiniOM board. The FPGA takes care of the coil drive and has also back-up clock in
case of CPU clock does not work. The FPGA takes care of the A/Dconversions which are
performed with a serial controlled SAR A/D-converter.
The digital band pass filtering and RMS conversion of the microphone signals is made with
FPGA circuit controlled by the VHDL code stored in the circuit. In order to filter out the
disturbances caused by acoustic noise, mechanical vibration and amplifier noise, the band
pass filters are designed to have as narrow a pass band as possible without slowing down the
filter's response to changes in the amplitude of the 164 Hz signal.
The FPGA circuit takes care of the digital communication between the miniOM sensor and the
module CPU.
The factory calibration coefficients of the sensor are stored in an EEPROM memory on the
miniOM board. When the module starts up, the calibration coefficients are read to the module
CPU and then used for calculating the O2 concentration from the Oxygen raw data received
from the sensor.
1.3.5 CPU board
The CPU board contains the processor, memories and an A/D-converter that is common to the
whole module.
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Product overview
The CPU board also contains sensors for pressures, the temperature and humidity as well as
drivers for valves, the fan and the pump. The module is connected to the module bus through
an RS-485 serial channel.
+3.3 V
+1.8 V
VCC_OM
mOM
Connector
+7 V
+5 V
mTPX
Connector
Humidity and
Temperature
sensor
ModBus_Data
Analog to
Digital
coversion
DCDC
Power
Supply
11.5…18 V
RS-485
Transceiver
Module
Bus
Connector
D25
RS-485
Zero Valve
Connector
4 Pressure
sensors
CPU Atmel
AT91RM9200
Valve
Control
Memories
Occlusion
Valve
Connector
SDRAM
32 Mbyte
NOR FLASH
8 Mbyte
Crystal
16 MHz
Crystal
32.678 KHz
Figure 12
ETC Valve
Connector
Pump
Control
Pump
Connector
Fan
Control
Fan
Connector
User Button
Connector
Signal processing on CPU board
1.3.6 MiniOM board
The miniOmM board contains electronics specific to the MiniOM sensor: FPGA circuit, coil drive,
A/D-converter etc. It also contains EEPROM memory that stores calibration data of the oxygen
measurement.
1.3.7 Main Component Interactions
The figure below describes the functionality of the module and the division of tasks between
different components.
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Figure 13
Block diagram
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Maintenance and checkout
2
Maintenance and checkout
To help ensure the equipment remains in proper operational and functional order, adhere to a
good maintenance schedule.
WARNING
WARNING
CAUTION
Only perform maintenance procedures specifically described in the manual.
Planned maintenance should be carried out annually. Failure to implement
the recommended maintenance schedule may cause equipment failure and
possible health hazards.
Do not apply pressurized air to any outlet or tubing connected to the module.
NOTE: The manufacturer does not, in any manner, assume the responsibility for performing the
recommended maintenance schedule, unless an Equipment Maintenance Agreement exists.
The sole responsibility rests with the individuals, hospitals, or institutions utilizing the device.
Corrective maintenance
Service personnel shall perform the following checkout procedure after any corrective
maintenance, before taking the module back into clinical use:
Required checkout procedure
Performed service
activity
Visual inspections Functional check
(section 3.2)
(section 3.3)
Front panel replacement
All steps
OM Reference gas filter
assembly
All steps
Check “2. Sample Flow Rate Check”
Module case opened either
for troubleshooting purpose
or for replacing any of the
internal parts.
All steps
All steps
Planned maintenance
Service personnel shall perform the following checkout procedure completely every 12 months
after installation:
1.
2.1. Replacement of planned maintenance parts
2.
2.2. Visual inspections
3.
2.3. Functional check
The instructions include a check form ("APPENDIX E") which should be filled in when performing
the procedures.
The symbol

in the instructions means that the check form should be signed after
performing the procedure.
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2.1 Replacement of planned maintenance parts
2.1.1 Required parts
Replace the following parts that wear in use at the recommended interval.
Description
Pieces
Replacement interval
Nafion Tube, 230 mm (mainflow)
1
Once a year
Nafion tube, 85 mm (zero line)
1
Once every 4 years
OM Reference gas filter assembly including
O-ring
1
Once a year
PM sticker
Once a year
CO2 absorber
1
Once every 4 years
It is also recommended to replace the D-fend Pro water trap, the gas sampling line as part of
the planned maintenance procedure.
NOTE: See the supplies and accessories document delivered with the manual for compatible
accessories.
2.1.2 Planned Maintenance Kits
The required planned maintenance parts are included in a PM kit.
Part number
M1206554
Description
Planned Maintenance Kit for E-sCO, E-sCAiO, N-CAiO modules.
The PM kit includes the required Nafion tubes, the OM reference gas
filter assembly with an O-ring and a PM sticker.
NOTE: The PM kit does not include the CO2 absorber. Order it separately.
2.1.3 Replacement procedures
Replace the specified planned maintenance parts according to the chapter "Disassembly and
reassembly" on page 8-31.
1.
Replace the CO2 absorber every 4 years.
2.
Replace the special tubes (Nafion) and check the condition of the internal tubing.
•
Check that the tubing inside the module is not contaminated. Any contamination
inside the tubing may indicate that the valves or sensors are contaminated, too. This
can increase a risk of faulty operation in valves or sensors. The valves or gas sensors
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Maintenance and checkout
are not possible to clean in the field. Therefore, if you noticed any contamination in
the module tubing, send the module to GE Healthcare for factory service.
NOTE: The nafion tubes do not include the silicon fittings they connect to. Use the original
silicon fittings unless they are damaged or leaking.
3.
Replace the OM reference gas filter assembly.
4.
Check that the fan and ventilation hole are not covered in dust.
2.2 Visual inspections
Detach the module from the module slot and check that:
•
•
•
•
•
the front cover is intact
all connectors are intact and are attached properly
the module box and latch are intact
the D-fend Pro and its connectors are clean and intact
the module and the applied parts are clean
The cleaning precautions, cleaning requirements, cleaning procedures, and recommended
cleaning solutions for the monitor are described in the monitor user’s manual. For details about
cleaning, disinfecting and sterilizing the accessories, see the instructions for use in the
accessory package.

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2.3 Functional check
Turn on the monitor. Wait until the normal monitoring screen appears.
2.3.1 Test setup
Required tools
−
A barometer
−
A mass flowmeter for measuring air flow, minimum measurement range from 0 to 200
ml/min, accuracy 5% or better in the 0 to 200 ml/min range.
−
P/N: 755534-HEL Calibration Gas Regulator
−
P/N: 755583-HEL Calibration gas, CO2, O2, N2O, DESF, package of 1 can (with E-sCAiO,
N-CAiO modules)
−
P/N: 755581-HEL QUICK CAL calibration gas, CO2, O2, N2O, package of 4 cans (with E-sCO
module)
−
P/N: M1006864, Calibration Gas Regulator, US only
−
P/N: 755571-HEL, Calibration Gas, 5% CO2, 54.5% O2, 36.0% N2O, 2.0% DESFLURANE, BAL
N2 (with E-sCAiO, N-CAiO modules) US only
−
P/N: 755587, Calibration Gas, CO2, O2, Balance, 4 cans/pkg (with E-sCO module) US only
−
D-fend Pro water trap
−
3 m / 10 ft anesthesia gas sampling line
−
Adult D-Lite sensor
−
A pressure manometer with either an integrated or a separate pressure pump
−
Forceps
NOTE: See the supplies and accessories document delivered with the manual for compatible
accessories.
Connections
•
Disconnect the module from the monitor, if connected.
Monitor configuration
•
Configure the CO2, O2, AA, and Flow waveform fields to the monitor screen with adequate
priority.
2.3.2 Procedure
Mark each task as complete on the checkout form.
1.
Gas Sampling System Leak Test
NOTE: The gas module shall be disconnected from the monitor during the leak test.
Check the gas sampling system for possible leakages.
•
•
•
Disconnect the module from the monitor.
Detach the module front cover and casing.
Block the OM reference tube with the forceps. Correct positioning of the forceps is
indicated by the figure below.
NOTE: Be careful when attaching the pincers to the tube and avoid stretching the
tube. Short pieces of silicone tubing on the forcep jaws can be used to protect the
tube from breaks that may appear when the tube is compressed between the jaws.
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Document no. 2081505-001
Maintenance and checkout
•
•
•
Connect a new D-fend Pro water trap to the module.
•
•
Block the sample gas out (gas exhaust) connector.
•
Check that the pressure reading does not drop more than 2 mmHg during 25
seconds.
•
Release the forceps, and reassemble the module. Make sure that the tubing fits
nicely into the module casing.
Connect a new gas sampling line to the sampling line connector in the water trap.
Connect the other end of the gas sampling line to a pressure manometer and a
pressure pump.
Pump 80 mmHg ± 20 mmHg pressure to the gas sampling system. Let the pressure
stabilize for approximately 10 - 20 seconds.

2.
Sample Flow Rate Check
Check the sample flow rate. Connect the module to the monitor.
NOTE: Gas measurement is not available during the first 1 to 5 minutes after the module
is connected due to warming up. A message 'Calibrating Gas Sensor' is shown in the
waveform field. Wait until warm-up is completed before proceeding with the next steps.
NOTE: The ambient temperature and air pressure influence the flow rate measured by the
flow meter. A flow meter, which has been calibrated at 21.11 °C (70 °F) and 760 mmHg
(1033 cmH2O), measures the flow rate correctly under the same conditions, i.e. in room
temperature at sea level. A flow rate correction as instructed by the manufacturer of the
flow meter needs to be performed when measuring flow rate under other conditions, for
example in high altitude.
•
Connect the gas sampling line (3 m / 10 ft with E-sCO, E-sCAiO and N-CAiO) to the
sampling line connector.
•
•
Connect the other end of the gas sampling line to a flowmeter.
Check the sample flow rate reading from the flowmeter. The flow rate shall be within
the specification limit 120 ± 20 ml/min.
NOTE: Readjustment is needed, if the measured value is not within the specification limit.
Adjust the sample gas flow rate according to the instructions in section “3.1.2. Sample
Flow Rate Adjustment”.
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
3.
Reference Gas Flow Rate Check
Check the flow rate in reference gas inlet:
•
•
•
Connect the module to the monitor.
•
Check that the Reference Flow is within the following range:
10 - 50 ml/min with E-sCO, E-sCAiO and N-CAiO modules
•
•
Detach the water trap.
Leave the other end of the gas sampling line open to room air.
Connect the flowmeter to the OM reference gas inlet on the side of the module with
a piece of tubing.
Attach the front cover.

4.
Fan
•
•
Check that the gas module's fan is running behind the D-fend Pro water trap.
Attach the water trap

5.
Zero Valve Operation
Test the zero valve functionality:
•
•
Connect the gas regulator to the calibration gas container.
•
Enter to gas service menu: select Monitor Setup > Install/Service (16-4-34) >
Service (26-23-8) > Parameters > Gas Unit > Gases.
•
Start feeding the specified calibration gas. Wait until the gas values shown in the
Gas calibration menu rise approximately to the level indicated in the labelling of the
calibration gas container.
Connect the end of the gas sampling line to the regulator on the gas container.
Leave the regulator overflow port open to room air.
NOTE: The gas values in the gas service menu is in percentages (%).
•
•
•
•
Open the zero valve to room air by selecting Zero valve ctrl.
Check that the CO2, N2O and anesthesia agent values drop back near 0% and the
O2 reading near 21% (room air).
Stop feeding the calibration gas.
Turn the zero valve back to the normal measurement position by selecting ZERO to
MEAS. (measurement position).

6.
Gas Calibration
Perform gas calibration according to the instructions in section “3.2. Gas Calibration”.
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Document no. 2081505-001
Maintenance and checkout

7.
Agent Identification
NOTE: Perform this test only for E-sCAiO and N-CAiO modules.
Check agent ID unreliability:
•
•
Feed the specified calibration gas for at least 30 seconds.
Check that the anesthesia agent is identified as Desflurane and the ID unrel. value
(=agent ID unreliability) shown in the gas service menu is lower than 75.
If the value is higher, repeat the gas calibration and check the value again.

8.
Ambient Pressure
Use a barometer to check the operation of the absolute pressure sensor.
•
Check that the ambient pressure value shown in the gas service menu does not
differ more than ± 13.33 mbar from the value shown by the barometer.

9.
Occlusion detection
•
•
Block the tip of the sampling line by your finger.
Check that a 'Sample line blocked' and ‘Low gas sample flow’ message appears on
the screen within 30 seconds.

10.
Air Leak detection
•
•
•
Detach the D-fend Pro water trap.
Check that the message 'Check D-Fend' appears on the screen within 30 seconds.
Attach the water trap.

11.
Gas exhaust blockage
•
•
Block the gas exhaust connector with your finger.
Check that the message 'Check sample gas out' appears on the screen within 30
seconds.

12.
Airway Gases
•
•
Breathe a minimum of 5 times to the tip of the sampling line.
Check that a normal CO2 waveform appears to the waveform field and the EtCO2
and FiCO2 values are updated on the screen.
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Document no. 2081505-001
B40/B20 Patient Monitor

13.
Apnea detection
•
•
Stop breathing to the gas sampling line.
Check that an 'Apnea' alarm appears to the message field within 30 seconds.

2.3.3 Test completion
•
Select Discharge patient to discard any changes made to the monitor configuration
during checkout.
•
•
Disconnect and reconnect the module before starting a new case.
Fill in all necessary documents.
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Document no. 2081505-001
Calibration and adjustments
3
Calibration and adjustments
3.1 Sample Flow Rate Adjustment
Sample flow rate shall be adjusted:
•
if the sample flow rate check in section “2.3.2. Procedure” failed.
3.1.1 Calibration setup
Required tools
−
A mass flowmeter for measuring air flow, minimum measurement range 0 to 200 ml/min,
accuracy 5% or better in the 0 to 200 ml/min range.
−
3 m / 10 ft anesthesia gas sampling line.
NOTE: See the supplies and accessories document delivered with the manual for compatible
accessories.
NOTE: Use only accurate, properly maintained, calibrated and traceable calibration tools for
the parameter calibration to ensure measurement accuracy.
NOTE: If the flow meter unit is not ml/min, it shall be converted to ml/min according to the
instructions of the flow meter manufacturer.
NOTE: Gas module sample flow rate is calibrated in the factory to ambient air conditions
corresponding the flow at the end of 3 m sampling line. Make sure that your meter is also
showing the flow at ambient conditions (= ATP).
NOTE: Refer to the flowmeter documentation for user instructions.
Connections
1.
Ensure that the module is connected to the monitor.
2.
Ensure that you have a new D-fend Pro water trap in use.
3.
Connect a new gas sampling line to the sampling line connector in the water trap.
4.
Connect the other end of the gas sampling line to the flow meter.
NOTE: Before checking or adjusting the sample flow, make sure there is no leakage in the
sampling system.
3.1.2 Sample Flow Rate Adjustment
1.
Enter to gas service menu: select Monitor Setup > Install/Service (16-4-34) > Service
(26-23-8) > Parameters > Gas Unit > Gases.
2.
Select Sample gain adj
3.
Adjust the sample flow to the nominal value 120 ml/min by increasing or decreasing
Sample Flow Gain:
•
To decrease the sample flow rate measured by the flow meter by approximately 7.5
ml/min, add gain value by 0.05.
•
To increase the sample flow rate measured by the flow meter by approximately 7.5
ml/min, lower the gain value by 0.05.
4.
Press Trim Knob to confirm the gain adjustment. Wait until the sample flow value shown
on screen returns near to the nominal value 120 ml/min and then check the actual
measured flow rate from the flow meter.
5.
Repeat steps 3 and 4 until the flow meter shows a 120 ± 20 ml /min flow rate.
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NOTE: Adjust the flow rate according to the reading in the flow meter. The flow rate reading in
the Gases menu is measured by the internal electronics and settles always back to the nominal
120 ml /min independent on the real flow rate.
3.2 Gas Calibration
WARNING
WARNING
Failure in zeroing or calibrating gases might cause inaccurate readings.
Since calibration gas contains anesthetic agents, always ensure sufficient
ventilation of the room during calibration.
Gas calibration shall be performed:
•
•
each time planned maintenance is performed.
each time corrective maintenance is performed.
NOTE: Gas calibration is a normal user action. Refer to the monitor user’s manual for the
recommendation for gas calibration interval in clinical use.
3.2.1 Calibration setup
Required tools
−
P/N: 755534-HEL Calibration Gas Regulator
−
P/N: 755583-HEL Calibration gas, CO2, O2, N2O, DESF, package of 1 can (with E-sCAiO and
N-CAiO modules)
−
P/N: 755581-HEL QUICK CAL calibration gas, CO2, O2, N2O, package of 4 cans (with E-sCO
module)
−
P/N: M1006864, Calibration Gas Regulator, US only
−
P/N: 755571-HEL, Calibration Gas, 5% CO2, 54.5% O2, 36.0% N2O, 2.0% DESFLURANE, BAL
N2 (with E-sCAiO and N-CAiO modules) US only
−
P/N: 755587, Calibration Gas, CO2, O2, Balance, 4 cans/pkg (with E-sCO module) US only
−
3 m / 10 ft anesthesia gas sampling line
NOTE: Use only the specified GE Healthcare calibration gas for the gas calibration to ensure
measurement accuracy. Do not use any other calibration gases. Check the calibration gas
container's labelling to ensure that the calibration gas has not expired.
NOTE: Ensure that the gas regulator is functioning properly before gas calibration. Refer to the
gas regulator's "Instructions for Use" letter for the annual maintenance instructions.
Connections
1.
Ensure that the module is connected to the monitor.
2.
Ensure that you have a new D-fend Pro water trap in use.
3.
Connect the gas regulator to the calibration gas container.
4.
Connect a new gas sampling line to the sampling line connector in the water trap.
5.
Connect the other end of the gas sampling line to the regulator on the gas container.
Leave the regulator overflow port open to room air.
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Document no. 2081505-001
Calibration and adjustments
Figure 14
Connecting a gas regulator to the calibration gas container and
connecting a sampling line to the gas regulator.
3.2.2 Procedure
NOTE: Gas calibration is not available during the first 5 minutes after the module is connected.
For maximum accuracy, let the monitor to warm up for 30 minutes before starting calibration.
NOTE: Gas calibration is not available during a 'Sample line blocked', 'Check D-Fend' and
'Check sample gas out’ alarm condition. Resolve the alarm condition before starting
calibration.
1.
Enter to gas calibration menu: Airway Gas > Gas Calibration
2.
The monitor will start automatic zeroing of the gas sensors. Wait until the message
'Zeroing' is replaced by a message 'Zero Ok' for all measured gases.
3.
Open the regulator after a message 'Feed gas' is shown for all measured gases. The
measured gas concentrations are shown in real-time in the gas calibration menu.
Continue feeding the calibration gas until the measured gas concentrations are stabilized
and a message 'Adjust' is shown for all measured gases. Close the regulator.
4.
Use the Trim Knob to adjust the gas readings shown in the Calibration menu to match
with the gas readings in the labelling of the calibration gas container. Press Trim Knob to
accept the adjusted values when the gas readings match each other.
5.
Wait until a message 'Ok' is shown for all measured gases.
NOTE: A message 'Zero Error' is shown in case the zeroing fails.
NOTE: A message 'Calibration Error' is shown, if you do not start feeding gas within 1 minute
after the automatic zeroing is completed, or if the calibration fails due to too large gain
adjustment.
NOTE: If zeroing or calibration failed, select the Recalibrate to restart the calibration procedure
from the beginning.
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4
Troubleshooting
The problems and solutions in this chapter represent only a few of the faults that you may
encounter and are not intended to cover every possible problem that may occur.
This chapter focuses on troubleshooting technical problems. Refer also to the troubleshooting
hints on the “User’s Guide” for troubleshooting monitoring problems, performance issues and
clinical configuration issues.
NOTE: Perform the checkout procedure described in chapter “2. Maintenance and checkout”
each time after you have opened the module casing.
If the problem remains, call technical support for service. To ensure accurate problem solving,
please be prepared to provide the following information:
•
•
•
•
Problem description and the troubleshooting done so far.
Device information.
Error messages displayed, if any.
Other information, as requested.
4.1 Visual inspection
Before beginning any detailed troubleshooting, complete thorough visual inspection to be sure
that:
•
•
•
•
•
•
the front cover is intact
•
•
Check that the module in doubt is compatible with the monitor.
the water trap connection and disconnection functions properly
all connectors are intact, clean and are attached properly
the module box and latch are intact
the metal D-fend Pro connectors are clean and intact
Check if there are any messages shown in the message field. Find the possible cause and
solution from the “Messages” section in "User’s Guide" .
Check to the accessories used with the module. If in doubt, replace the accessories with
known good ones.
If in doubt of having any loose parts or cable connections inside the module, detach the
module box by removing the four screws from the back of the module and check that:
•
•
•
•
•
all screws are tightened properly
all cables are connected properly
tubes are not pinched and there are no sharp bends on them
all tubes are connected properly
there are no loose objects inside the module
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Document no. 2081505-001
Troubleshooting
4.2 Troubleshooting checklist
The following simple troubleshooting hints may help you to localize and isolate a functional
problem to the correct unit. Ensure that the monitor is turned on and the module is connected.
4.2.1 Gas sampling system troubleshooting
•
Faults which can occur in the sampling system are: leaks or blockages in the tubing,
failure of the sampling pump or the magnetic valves, or diminishing of the flow rates
because of dirt or other matter accumulating in the internal tubing or failure of pressure
sensors.
•
Whenever suspecting the sampling system and always after having done any work on
the sampling system, check the sampling system for leakages and check the flow rate.
•
The D-fend Pro water trap should be replaced, when the 'Replace D-Fend' message
appears.
•
If any liquid has entered the MiniTPX measuring unit due to water trap filter failure,
contact GE Healthcare service.
•
Check that the tubing inside the module is not contaminated.
Any contamination inside the tubing may indicate that the valves or sensors are
contaminated, too. This can increase a risk of faulty operation in valves or sensors. The
valves or gas sensors are not possible to clean in the field. Therefore, if you noticed any
contamination in the module tubing, send the module to GE Healthcare for factory
service.
NOTE: All internal tubes are mechanically fragile. Sharp bends may cause leaks and occlusions.
4.2.2 MiniOM Measuring unit troubleshooting
•
Due to the complicated and sensitive mechanical construction of the oxygen measuring
unit, no repairs should be attempted inside the unit. Instead, if the fault has been found in
the measuring unit itself, the entire module should be replaced and the faulty module be
sent to GE Healthcare for repair.
•
In cases of no response to O2 or strong drift, check the tubing for loose connections,
blockages, and leaks.
•
•
Check also the OM reference gas filter assembly, and replace if needed.
If the O2 signal is noisy, check the measurement unit suspension and if the MiniOM tubing
has tension.
NOTE: Never apply overpressure to the O2 measuring unit, as the pressure transducer may be
permanently damaged.
4.2.3 MiniTPX Measuring unit troubleshooting
•
The MiniTPX measuring unit can only be repaired at the factory. In case of failure, the
entire module should be replaced and the faulty module be sent to GE Healthcare for
repair.
4.2.4 CPU board troubleshooting
•
Due to the complexity of the large scale integrated circuitry, there are few faults in the
CPU digital electronics that can be located without special equipment.
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Document no. 2081505-001
B40/B20 Patient Monitor
•
•
Check that all connectors and screws are properly installed.
In case of failure, the entire module should be replaced and the faulty module be sent to
GE Healthcare for repair.
4.3 Service Interface
The monitor has a service menu, which is a useful tool to examine monitor functions and
troubleshoot it in case a fault occurs.
To enter to the service menu see Chapter 5.
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Document no. 2081505-001
Troubleshooting
4.4 Messages
4.4.1 Gas measurement
Message
Possible causes
Water trap is not connected.
Check D-Fend
Check D-Fend and
sample gas out. Wait for Air leak inside the internal tubing.
30 sec and press Normal
screen to continue.
Sample line blocked
Continuous blockage.
Check sampling line
and D-Fend.
Connect the water trap and sampling
line to the module.
Check the internal tubing for leakages.
Replace, if needed.
Gas sampling line is blocked.
Check the external gas sampling line for
blockages. Replace, if needed.
Water trap container is full.
Empty the water trap container.
Water trap is occluded.
Replace the water trap.
Internal tubing is blocked.
Check the internal tubing for blockages.
Replace, if needed.
Check sampling gas out The sample gas outflow is blocked.
Check D-Fend and
sample gas out. Wait for
30 sec and press Normal
screen to continue.
Internal tubing is blocked.
Pump failure.
Replace D-Fend
Possible solutions
Check the sample gas out connector in
the front panel and the exhaust line for
gas return or scavenging for blockages.
-
If the sample gas is returned to the
patient circuit, check that there is no
occlusion in the tubing.
-
If the sample gas outlet is connected
to a scavenging system, make sure
an open system is used where gas is
removed in room pressure.
Check the internal tubing for blockages.
Check sample pump operation by
measuring the sample gas flow rate.
Replace pump, if needed.
Defective or contaminated D-fend Pro.
Replace the D-fend Pro water trap.
Occlusion in internal tubing.
Check sample and reference flows.
Perform a visual check for the internal
tubing. Remove the cause for occlusion.
Calibrating
Gas calibration is in progress.
Wait until the calibration is completed
successfully.
Failure in Agent ID
Agent ID has failed.
Perform gas calibration. Check agent ID
unreliability (see functional check). If it
does not help, send the module to GE
Healthcare for factory repair.
Zeroing
Zeroing is in progress.
Wait until zeroing is completed
successfully.
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Message
Possible causes
Possible solutions
Zero error
Autozeroing during the measurement or Check the zero valve operation. Replace
in the beginning of the gas calibration
the zero absorber and Nafion tube in
failed.
zero line. If it does not help, send the
module to GE Healthcare for factory
repair.
Calibrating error
Feeding the calibration gas was not
started within 1 minute after the
automatic zeroing was completed.
Recalibrate.
Calibration was failed due to too large
gain adjustment.
Recalibrate.
Wrong calibration gas is used.
Use the specified calibration gas.
Over range
Measured FiO2 >103%
Perform gas calibration.
Apnea deactivated
Apnea alarm start-up conditions are not Apnea alarm detection is activated after
reached.
the 3 breaths are detected.
Sensor INOP
IR Lamp failure.
Check miniTPX flex cable connection.
Ambient pressure is too high or low.
Check the ambient pressure from the
Gas Calibrations menu.
CPU failure.
Replace CPU.
No response from the gas module, high Return the module to GE Healthcare for
service.
temperature inside the module, or
EEPROM checksum failure.
Incompatible gas
module
Incompatible gas module detected by
the monitor.
Check the compatibility of the gas
module.
Gas measurements
removed
The module is disconnected.
Reconnect the module.
Identical gas modules
The monitor detects gas measurement
from two or more modules.
Remove excess modules providing gas
measurement.
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Document no. 2081505-001
Troubleshooting
Message
Possible causes
Possible solutions
Sensor INOP
MiniOM unit failure
Check flex cable connection.
-
temperature
-
internal supply voltages
-
other internal failure
MiniTPX unit failure
-
temperature
-
internal supply voltages
-
IR lamp failure
CPU failure
-
internal supply voltages
-
pressure sensor failure
-
a/d-converter system failure
Other failure
-
Fan failure
-
Pump failure
-
Valve (Zero, Occlusion) failure
-
Check that fan can rotate freely.
Check fan, pump or valve wire
CO2 reference signal differs too much connection.
from CO2 signal
Zeroing fails too many times
Calibrating gas sensor
O2, CO2 and N2O measurements are not Wait until the warm-up is completed.
available during the first minute after
the module is connected due to
warm-up. Anaesthesia agent
measurement is not available during the
first 5 minutes after the module is
connected due to warm-up.
Over Scale
Incorrect waveform scale for the
parameter. The waveform clipped
because measured gas concentration
exceeds the upper limit of the current
scale.
Change to the appropriate waveform
scale. For detailed instructions refer to
the user’s manual.
Low gas sample flow
Sample flow deviates to less than 80%
of the module specific nominal flow
value.
Check sample flow rate. Adjust, if
needed.
Gas sampling line, gas output, water
trap, or internal tubing is blocked.
Check or replace the gas sampling line,
water trap, or internal tubing.
Pump failure.
Replace the pump unit.
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4.5 Troubleshooting charts
4.5.1 Gas measurement
Problem
Possible clinical cause Possible technical
cause
too low EtCO2 value
-
sudden decrease in
circulation
-
leak in sampling system
-
check all connections
-
calibration error
-
check calibration
-
pulmonary embolism
-
-
hyperventilation
high by-pass flow from
ventilator
-
very large dead-space
-
large shunting
-
hypoventilation
-
D-fend Pro contaminated -
change D-fend Pro
-
increased metabolism
-
calibration error
-
check calibration
-
incorrect scaling
-
change scale
-
sampling line or water
trap loose or blocked (air
leak)
-
check all connections
-
sample gas out blocked
-
check that outlet is
open
abnormally high EtCO2
-
CO2 sensor contaminated -
(permissive hypercapnia)
-
D-fend Pro malfunction
-
change D-fend Pro
-
-
Dry gas as default
-
change to Wet gas For
detailed instructions
refer to the user’s
manual.
too high EtCO2
waveform clipped
no response to
breathing
EtCO2 overscale
>15% (>20%) Shown
until 32%,
-
apnea
-
disconnection
-
What to do
call service technician
specified range
0...15%
EtCO2>PaCO2
unit is mmHg or kPa
and EtCO2 is close to
arterial PCO2
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Document no. 2081505-001
Disassembly and reassembly
5
Disassembly and reassembly
5.1 Disassembly guidelines
WARNING
WARNING
WARNING
Disconnect the module from any monitoring system before performing any
repair.
Always perform Gas Sampling System Leak Test after the module cover is
reassembled.
Always perform gas calibration after any planned or corrective
maintenance.
Field service of the module is limited to replacing the serviceable parts listed below (see also
chapter “6. Service parts”). Attempting a field repair on any other parts could jeopardize the
safe and effective operation of the module, and void the warranty.
NOTE: Only a qualified service technician should perform field replacement procedures.
NOTE: Perform the checkout procedure described in chapter “2. Maintenance and checkout”
after you have disassembled and reassembled the module.
5.1.1 Serviceable parts
•
•
•
•
•
•
•
•
CO2 Absorber
D-fend Pro
Nafion tubes
Front chassis unit
Pump
OM reference filter
Latch and spring
Mechanical parts listed in chapter “6. Service parts”
5.1.2 Service limitations
The following parts are not serviceable:
•
•
MiniOM Measuring unit
MiniTPX measuring unit
NOTE: Due to the complicated and sensitive mechanical construction of the oxygen measuring
unit, no repairs should be attempted inside the unit. Instead, if the fault has been found in the
measuring unit itself, the entire module should be replaced and the faulty module be sent to
GE Healthcare for repair.
NOTE: The MiniTPX measuring unit can only be repaired and calibrated at the factory. In case of
failure, the entire module should be replaced and the faulty module be sent to GE Healthcare
for repair.
5.1.3 ESD precautions
WARNING
Protect module from electrostatic discharge.
All external connectors of the module are designed with protection from ESD damage.
However, if the module requires service, exposed components and assemblies inside are
susceptible to ESD damage. This includes human hands, non-ESD protected work stations or
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improperly grounded test equipment. The following guidelines may not guarantee a 100%
static-free workstation, but can greatly reduce the potential for failure of any electronic
assemblies being serviced:
•
Discharge any static charge you may have built up before handling semiconductors or
assemblies containing semiconductors.
•
A grounded, antistatic wristband or heel strap should be worn at all times while handling
or repairing assemblies containing semiconductors.
•
•
Use properly grounded test equipment.
•
Do not remove semiconductors or assemblies containing semiconductors from antistatic
containers until absolutely necessary.
•
•
•
Do not slide semiconductors or electrical/electronic assemblies across any surface.
•
•
Handle all PCB assemblies by their edges.
Use a static-free work surface while handling or working on assemblies containing
semiconductors.
Do not touch semiconductor leads unless absolutely necessary.
Semiconductors and electronic assemblies should be stored only in antistatic bags or
boxes.
Do not flex or twist a circuit board.
5.1.4 Protection from dust
WARNING
Module must be handled to prevent dust from entering the gas sampling
system.
The gas sampling system must be protected from dust entering the tubes, valves and other
components. In order to achieve this goal, the following measures must be taken:
•
•
•
•
Have the D-fend Pro water trap always connected to the module.
•
Remove the protective caps on the gas pump only immediately before assembling it to
the module.
•
Take the CO2-absorber out from the plastic bag only immediately before assembling it to
the module.
•
The clothing of the service person must be such that the dust risk is taken into account.
Clean and dust free working environment during all service procedures.
Minimize the times with any open connections in the gas sampling system.
Always close the open tube connections of the sampling system when not working on the
module.
5.1.5 Before disassembly
•
Note the positions of any sampling tubes, wires or cables. Mark them if necessary to
ensure that they are reassembled correctly.
•
Save and set aside all hardware for reassembly.
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Disassembly and reassembly
5.1.6 Required tools
-
Torx T8 and T10 screwdrivers
-
flat blade screwdriver
-
forceps
-
antistatic wristband
5.2 Disassembly and reassembly procedure
Disassembling the module (see the exploded view of the module in chapter “Service parts”:
Reassembling the module: reverse the order of the disassembly steps.
Check that:
•
•
•
•
all screws are tightened properly
all cables are connected properly
tubes are not pinched and there are no sharp bends on them
all tubes are connected properly
NOTE: Make sure that the Nafion tubes are routed in such a way that they don’t come near the
fan, and there is no risk of the fan being obstructed by the tubes. An obstructed fan will result in
degraded ventilation inside the module, and a ‘Sensor inop’ message being displayed.
•
there are no loose objects inside the module
5.2.1 Disassembly workflow
Use this workflow diagram to find the simplest way to disassemble the required parts of the
module. Follow the arrows from the top down to the required part and disassemble the module
by following the steps in between.
E-sCO,E-sCAiO or N-CAiO module
D-Fend
Front cover
Module casing
Nafion
CO2 absorber
OM holder
Front chassis unit
Main flow connector
Latch
Pump
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5.2.2 Detaching the Front Cover
1. Remove the D-fend Pro.
2. Release the two snaps on both sides of the module by using
a flat blade screwdriver.
3. Detach the front cover.
5.2.3 Detaching the Module Casing
1. Remove the two T10 screws mounting the D25 connector
shield.
2. Detach the connector shield.
3. Remove the two Pozidrive screws.
4. Push the latch and pull the module casing.
NOTE: When reassembling ensure that the module casing does
not damage the conductive sealings on the front chassis unit.
5.2.4 Replacement of Planned Maintenance Parts
1. Carefully remove the main flow nafion tube and every 4th
year the shorter zero line nafion tube.
NOTE: Remember the route of the tubes and reassemble
correctly.
NOTE: Make sure that the Nafion tubes are routed in such a way
that they don’t come near the fan, and there is no risk of the fan
being obstructed by the tubes. An obstructed fan will result in
degraded ventilation inside the module, and sensor inop
message being displayed.
NOTE: The nafion tubes do not include the silicon fittings they
are connected to. Use the original silicon fittings unless they are
not damaged or leaking.
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Disassembly and reassembly
2. Pull out the OM reference filter assembly with forceps.
3. Push the new filter assembly until it is on the same level with
the front chassis.
5.2.5 Replacement of CO2 Absorber
1. Lift the CO2 absorber from the slot.
2. Detach the tubes from the absorber.
3. Connect the tubes to a new CO2 absorber and place it to the
slot.
5.2.6 Detaching the Latch
1. Pull the latch from the front chassis.
NOTE: Remember to detach the front cover first.
2. Remove the spring by squeezing it.
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5.2.7 Detaching the Front Chassis Unit
1. Remove the two T10 screws.
2. Carefully detach the three tubes.
3. Disconnect the fan cable.
4. Detach the front chassis unit.
5.2.8 Detaching the Main Flow Connector
Original Main Flow Connector is required to maintain proper gas flow restriction in the module.
When the Front Chassis Unit is replaced move the original connector to the new unit.
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Disassembly and reassembly
1. Carefully detach the lock pin holding the main flow
connector.
2. Carefully attach the main flow connector to the new front
chassis unit.
5.2.9 Detaching the Pump
1. Carefully detach the tube from the pump.
2. Disconnect the pump cable from the CPU board.
3. Lift the pump from the metal brackets.
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5.2.10 Detaching the OM holder
1. Carefully detach the three tubes from the OM unit.
2. Carefully disconnect the OM flex cable from the CPU board.
3. Carefully pass the flex cable through metal frame.
4. Lift the OM unit with the holder from the metal brackets.
5. Detach the holder.
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Service parts
6
Service parts
6.1 Ordering parts
To order parts, Contact GE Healthcare. Contact information is available at
www.gehealthcare.com. Make sure you have all necessary information at hand.
NOTE: Perform the checkout procedure described in chapter “2. Maintenance and checkout”
after you have disassembled and reassembled the module.
6.1.1 Planned Maintenance Kits
The required planned maintenance parts are included in a PM kit.
Part number
Description
M1206554
Planned Maintenance Kit for E-sCO, E-sCAiO, N-CAiO modules. The PM
kit includes the required Nafion tubes, OM reference filter assembly with
O-ring and PM Sticker.
NOTE: The PM kit does not include the CO2 absorber. Order it separately.
6.2 Spare parts for E-sCAiO, E-sCO, N-CAiO
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Item
Description
Order No.
1
FRU, Front Chassis Unit, E-sCAiO, E-sCO, N-CAiO
M1206530
3
Front Chassis Assembly
FRU, HW Kit, E-sCO, E-sCAiO, N-CAiO
-
All Mounting Screws
-
All Conductive Sealings
-
Pump Connector Silicone Tube
-
D25 Connector Shield
-
Latch
-
Torsion Spring
M1206533
Item
Description
Order No.
4
FRU, Pump Unit, E-sCO, E-sCAiO, N-CAiO
M1206290
5
FRU, OM Holder, E-sCO, E-sCAiO, N-CAiO
M1206531
7
CO2 Absorber, E-sCO, E-sCAiO, N-CAiO
M1206555
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Service parts
6.2.1 Front covers
Item
Description
Order No.
8
FRU, Front Cover, E-sCAiO
M1206538
8
FRU, Front Cover, US, E-sCAiO
M1206558
8
FRU, Front Cover, E-sCO
M1206539
8
FRU, Front Cover, US, E-sCO
M1206559
8
FRU, Front Cover, N-CAiO
2074385-001
8
FRU, Front Cover, US, N-CAiO
2074386-001
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9 E-Entropy Module
Product overview
1
Product overview
1.1 Introduction
This document provides information for the maintenance and service of the Entropy Module,
E-ENTROPY. The Entropy module uses an electroencephalography (EEG) signal, together with
spontaneous facial muscular activity with a frontal electromyography (FEMG) signal to
measure:
•
•
•
Response Entropy (RE)
State Entropy (SE)
Burst Suppression Ratio (BSR)
The Entropy module is responsible for EEG and FEMG signal acquisition, amplification, filtering
and digitization, and electrode impedance measurement. All the calculated parameters can be
selected on the display and trended.
Figure 1
Measurement setup
(1)
Entropy module
(2)
Entropy sensor cable
(3)
GE Entropy sensor
(4)
Entropy sensor
1.2 Measurement principle
Entropy is a measure of irregularity in any signal. During general anesthesia, EEG changes
from irregular to more regular patterns when anesthesia deepens. Similarly, FEMG quiets down
as the deeper parts of the brain are increasingly saturated with anesthetics. The Entropy
Module measures these changes by quantifying the irregularity of EEG and FEMG signals.
Entropy parameters and BSR are calculated from EEG and FEMG signals acquired with a
sensor which is attached to the patient's forehead. The sensor consists of three electrodes. This
referential measurement yields one channel of raw EntrEEG.
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Figure 2
A general view of the cable connections
1.2.1 EntrEEG
EEG is a differential voltage signal measured from electrodes attached to the patient’s skin.
EEG measures the spontaneous electrical activity of the brain. This electrical activity reflects
the state of the brain. In referential measurement, the referential electrode delivers its potential
to every channel’s minus-input. The signal is the potential difference between this common
reference electrode (electrode #3) and the electrode connected to the plus input (electrode #1).
The purpose of the ground electrode (electrode #2) is to reduce common mode noise.
The EntrEEG signal is amplified, antialias filtered, digitized and software filtered. After that, the
EntrEEG signal is shown on the screen and the RE, SE and BSR characteristics are calculated
from it.
1.2.2 FEMG
FEMG is an electrical signal originating from facial muscles. The FEMG signal has much broader
spectrum than EEG and it overlaps with EEG at low frequencies. The FEMG signal gives its
contribution to the RE values (see “RE and SE”). Mains power frequency and its harmonics are
digitally filtered away to reject interference noise from power lines.
1.2.3 RE and SE
Entropy numbers range from 100 to zero (RE 0-100, SE 0 – 91), correlating to the patient's
anesthetic state. High values of Entropy indicate high irregularity of the signal, signifying that
the patient is awake. There are two Entropy parameters: the fast-reacting Response Entropy
and the more steady and robust State Entropy. State Entropy consists of the entropy of EEG
signal calculated up to 32 Hz. Response Entropy includes additional high frequencies up to 47
Hz and, consequently, the fast frontalis EMG (FEMG) signals enable a fast response time.
Table 1
Frequency ranges for Entropy calculation
Response Entropy, RE
0 < f < 47 Hz
State Entropy, SE
0 < f < 32 Hz
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Product overview
1.2.4 Impedance measurement
The impedance measurement is performed for all leads at the same time and the EntrEEG is
stopped for no longer than 5 seconds during the impedance measurement.
Differences in the electrode impedance of the electrodes cause common mode noise coupling
to the measured signal. To minimize this, the electrode impedance is measured and a warning
of an unsatisfactory impedance level is generated when necessary. The impedance of an
electrode is measured by applying a known current through the electrode and measuring the
voltage drop over the electrode. This way the impedance of a single electrode can be resolved.
1.3 Main components
1.3.1 Controls and connectors
Figure 3
Front panel of Entropy Module, E-ENTROPY, and the back of the
module
Module key
Module
Description
Entropy
E-Entropy
Opens the Entropy menu on
the screen
Check Sensor
E-Entropy
Starts the manual sensor check
Connector
Module
Description
Entropy
E-Entropy
Entropy connector
D25 connector
E-Entropy
Module bus connector
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1.3.2 Entropy board
The Entropy board consists of the following functional sections:
•
•
•
Microprocessor for measurement control, and for processing the measurement signal
Digital I/O circuit for smart chip communication (the chip is located in the entropy sensor)
Serial communication driver for module bus communication
Figure 4
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Entropy measurement system block diagram
IMC Connector Board
Amplification
&
Filtering
A/D Converter
Patient Isolation
Module Bus
The serial bus speed to the monitor is 500 kbps and the bus itself is half duplex, i.e. data can be
transferred to both directions but only one way at a time.
Maintenance and checkout
2
Maintenance and checkout
To help ensure the equipment remains in proper operational and functional order, adhere to a
good maintenance schedule.
Corrective maintenance
Service personnel shall perform the following checkout procedure after any corrective
maintenance, before taking the module back into clinical use:
Required checkout procedure
Performed service activity Visual inspections Electrical safety test
(section 3.1)
(section 3.2)
Functional check
(section 3.3)
Module casing opened
either for troubleshooting
purpose or for replacing
any of the internal parts.
All steps
All steps
All steps
Front cover, or an other
external part, replaced.
All steps
Not applicable
Not applicable
Planned maintenance
Service personnel shall perform the following checkout procedure completely every 24
months after installation:
1.
Visual inspections
2.
Electrical safety tests
3.
Functional check
2.1 Visual inspections
Detach the module from the module slot and check that:
•
•
•
•
the front cover is intact
all connectors are intact and attached properly
the module box and latch are intact
the module and the applied parts are clean
The cleaning precautions, cleaning requirements, cleaning procedures, and recommended
cleaning solutions for the monitor are described in the "User’s Guide". For details about
cleaning, disinfecting and sterilizing of the accessories, see the instructions for use in the
accessory package.

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2.2 Electrical safety tests
Complete the Electrical safety tests found in the “Electrical Safety Tests”, chapter 3. Perform
Patient leakage current tests, Patient (source) leakage current test and Patient (sink) leakage
current test.
Record the values of the tests on the "Service check form, E-Entropy" on page F-1.

2.3 Functional check
Turn the monitor on. Wait until the normal monitoring screen appears.
2.3.1 Test setup
Required tools
−
P/N: N-ES, Simulator for E-ENTROPY
−
Entropy sensor cable
NOTE: See the supplies and accessories document delivered with the manual for compatible
accessories.
Connections
•
Ensure that the module is connected to the monitor.
Monitor configuration
1.
Configure the Entropy waveform field to the monitor screen with adequate priority.
2.
Press the Entropy module key in the module to open the Entropy Setup menu and
configure:
Entr.EEG Scale: 250uV
Display format: RE+SE
Automatic sensor check: ON
2.3.2 Entropy tests
1.
Module and sensor recognition
•
•
Connect the Entropy sensor cable to the module.
•
Check that a 'No sensor' message is shown in the Entropy parameter window.
Check that the Entropy EEG waveform field and related information appears to the
screen.

2.
Sensor checking
•
•
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Document no. 2081505-001
Connect the Entropy simulator to the Entropy sensor cable.
Check that a 'Checking sensor' message appears after a while and wait until all 3
electrodes are checked. The sensor check is passed, if a green circle with a check
mark changes to orange with result text (PASS/FAIL) for each tested electrode is
shown.
Maintenance and checkout

3.
Functional check with a simulator
•
Check that the EntrEEG waveform and RE & SE values appear on the monitor screen
approximately 30 seconds after the sensor check is completed.

2.3.3 Test completion
•
Fill in all necessary documents, refer to "Service check form, E-Entropy" on page F-1
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3
Troubleshooting
The problems and solutions in this chapter represent only a few of the faults that you may
encounter and are not intended to cover every possible problem that may occur.
This chapter focuses on troubleshooting technical problems. For clinical and operation issues
refer to the "User’s Guide" for troubleshooting.
NOTE: Perform the checkout procedure described in chapter “2. Maintenance and checkout”
each time after you have opened the module casing.
If the problem remains, call technical support for service. To ensure accurate problem solving,
please be prepared to provide the following information:
•
•
•
•
Problem description and the troubleshooting done so far.
Device information.
Error messages displayed, if any.
Other information, as requested.
3.1 Visual inspection
Before beginning any detailed troubleshooting, complete thorough visual inspection to be sure
that:
•
•
•
•
the front cover is intact
•
•
Check that the module in doubt is compatible with the monitor.
all connectors are intact, clean, and attached properly
the module box and latch are intact
Check if there are any messages shown in the message field. Find the possible cause and
solution from the “Messages” section in "User’s Guide" .
Check to the accessories used with the module. If in doubt, replace the accessories with
known good ones.
If in doubt of having any loose parts or cable connections inside the module, detach the
module box by removing the two screws from the back of the module and check that:
•
•
•
•
•
screws are tightened properly
cables are connected properly
the EMC cover is attached properly in the module
there are no loose objects inside the module
Press a module key. Check that the related menu is opened or activity is started.
Inoperatibility may refer to a loose keypad cable or other problem in the module.
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Troubleshooting
3.2 Troubleshooting chart
Problem
Possible causes
No EntEEG waveform or Entropy Entropy module is not connected.
parameter window on the screen.
Possible solutions
Connect the Entropy module to
the monitor and the Entropy
sensor cable to the module.
Configure EntEEG waveform or
EntEEG waveform or Entropy
Entropy parameter to the screen,
parameter window is not configured to
or increase the priority of the
the screen, or the parameter priority is
parameter information.
set too low.
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4
Disassembly and reassembly
4.1 Disassembly guidelines
Field service of the module is limited to replacing the serviceable parts listed below (see also
chapter “5. Service parts”). Attempting a field repair on any other parts could jeopardize the
safe and effective operation of the module, and void the warranty.
NOTE: Only a qualified service technician should perform field replacement procedures.
NOTE: Perform the checkout procedure described in chapter “2. Maintenance and checkout”
after you have disassembled and reassembled the module.
4.1.1 ESD precautions
All external connectors of the module are designed with protection from ESD damage.
However, if the module requires service, exposed components and assemblies inside are
susceptible to ESD damage. This includes human hands, non-ESD protected work stations or
improperly grounded test equipment. The following guidelines may not guarantee a 100%
static-free workstation, but can greatly reduce the potential for failure of any electronic
assemblies being serviced:
•
Discharge any static charge you may have built up before handling semiconductors or
assemblies containing semiconductors.
•
A grounded, antistatic wristband or heel strap should be worn at all times while handling
or repairing assemblies containing semiconductors.
•
•
Use properly grounded test equipment.
•
Do not remove semiconductors or assemblies containing semiconductors from antistatic
containers until absolutely necessary.
•
•
•
Do not slide semiconductors or electrical/electronic assemblies across any surface.
•
•
Handle all PCB assemblies by their edges.
Use a static-free work surface while handling or working on assemblies containing
semiconductors.
Do not touch semiconductor leads unless absolutely necessary.
Semiconductors and electronic assemblies should be stored only in antistatic bags or
boxes.
Do not flex or twist a circuit board.
4.1.2 Before disassembly
•
•
Note the positions of any wires or cables. Mark them if necessary to ensure that they are
re-assembled correctly.
Save and set aside all hardware for reassembly.
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Disassembly and reassembly
4.1.3 Required tools
-
antistatic wristband
-
pincers
-
torx screwdriver, T10
-
flat blade screwdriver
4.2 Disassembling and reassembling procedure
Disassembling the E-ENTROPY module (see the exploded view of the module in chapter “5.
Service parts”):
4.2.1 To replace the front cover
1.
Detach the front cover of the module by releasing the snaps that hold the front cover to
the front chassis unit by using a small flat blade screwdriver. There are 2 snaps on both
sides of the module and 1 snap on the top.
4.2.2 To replace the Entropy board
1.
Remove the two screws (T10) from the back of the module.
2.
While pressing the release latch, pull the module casing slowly backwards and remove it
from the main body.
3.
Disconnect the front panel connector cable and the membrane keyboard cable from the
Entropy board.
4.
Detach the front cover (see 4.2.1).
5.
Detach the Entropy board by removing the two screws located near the front chassis unit.
Pull out the front chassis unit.
4.2.3 Reassembling the module
Reverse the order of the disassembly steps. Check that:
•
•
•
screws are tightened properly
cables are connected properly
there are no loose objects inside the module
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5
Service parts
5.1 Ordering parts
To order parts, Contact GE Healthcare. Contact information is available at
www.gehealthcare.com. Make sure you have all necessary information at hand.
NOTE: Perform the checkout procedure described in chapter “2. Maintenance and checkout”
after you have disassembled and reassembled the module.
5.2 Spare parts for E-ENTROPY
Item
Description
Order No.
1
Module Casing, Single
M1021035
2
SCREW, machine, M3x4mm, DIN7985, torx head, pan head, steel
*
3
Entropy Board, E-ENTROPY
M1093919
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Service parts
Item
Description
Order No.
4
SCREW, screw for plastic, x12mm, WN1452, torx head, pan head, steel, zinc,
SCREW-PT, PAN-HEAD, TORX, 3.0x12mm, ST-ZN, WN1452
*
5
SCREW, screw for plastic, x8mm, WN1452, torx head, pan head, steel, zinc,
SCREW-PT, PAN-HEAD, TORX, 3.0x8mm, ST-ZN, WN1452
*
6
IMC CONNECTOR BOARD, M-ENTROPY
8004791
7
Front Chassis Unit, E-ENTROPY
M1024285
8
Membrane Keyboard
M1012126
9
SCREW, machine, M3x8mm, DIN965, torx head, flat countersunk head, steel
*
10
Metal frame
879184
11
Ferrite holder, M-ENTROPY, Investment cast
M1002842
12
CONNECTOR CABLE, M-ENTROPY..01
8005305
13
Torsion Spring
M1020935
14
Latch
M1021039
15
Front Cover, EN, E-ENTROPY
M1021097
15
Front Cover, CS, E-ENTROPY
M1063322
15
Front Cover, DA, E-ENTROPY
M1024882
15
Front Cover, ES, E-ENTROPY
M1024939
15
Front Cover, FI, E-ENTROPY
M1024941
15
Front Cover, FR, E-ENTROPY
M1024942
15
Front Cover, HU, E-ENTROPY
M1046108
15
Front Cover, IT, E-ENTROPY
M1024943
15
Front Cover, JA, E-ENTROPY
M1024944
15
Front Cover, NL, E-ENTROPY
M1024945
15
Front Cover, NO, E-ENTROPY
M1024946
15
Front Cover, PL, E-ENTROPY
M1024947
15
Front Cover, PT, E-ENTROPY
M1024948
15
Front Cover, SV, E-ENTROPY
M1024949
15
Front Cover, DE, E-ENTROPY
M1020825
*) Part is not available from GE. Source locally.
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ElectroMagnetic Compatibility
APPENDIX A: ElectroMagnetic Compatibility
Table 1
Guidance and manufacturer’s declaration – electromagnetic
emissions
Guidance and manufacturer’s declaration – electromagnetic emissions
The monitor is intended for use in the electromagnetic environment specified below. The customer or the
user of the monitor should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The monitor uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class A
Hermonic emissions
Class A
The monitor is suitable for use in all establishments other than
domestic establishments and those directly connected to the
public low-voltage power supply network that supplies buildings
used for domestic purposes.
IEC 61000-3-2
Voltage fluctuations/
Class A
flicker emissions
IEC 61000-3-3
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Table 2
Guidance and manufacturer’s declaration – electromagnetic
immunity
Guidance and manufacturer’s declaration – electromagnetic immunity
The monitor is intended for use in the electromagnetic environment specified below. The customer or the user
of the monitor should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±6 kV contact
±8 kV air
±8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative
humidity should be at least 30%.
Electrical fast
transients/bursts
IEC 61000-4-4
±2 kV for power
supply lines
±2 kV for power
supply lines
Mains power quality should be that of
a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
±1 kV differential
mode
±2 kV common mode
±1 kV differential
mode
±2 kV common mode
Mains power quality should be that of
a typical commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations on
power supply lines
IEC 61000-4-11
<5% UT
(>95% dip in UT)
for 0.5 cycle
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
40% UT
(60% dip in UT)
for 5 cycles
Mains power quality should be that of
a typical commercial or hospital
environment. If user of the equipment
requires continued operation during
power mains interruptions, it is
recommended that the equipment be
powered from an uninterruptible
power supply or a battery.
70% UT
(30% dip in UT)
for 25 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 sec
<5% UT
(>95% dip in UT)
for 5 sec
3 A/m
3 A/m
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
NOTE UT is the a.c. mains voltage prior to application of the test level.
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Document no. 2081505-001
Power frequency magnetic field
should be at levels characteristic of a
typical location in a typical
commercial or hospital environment.
ElectroMagnetic Compatibility
Table 3
Guidance and manufacturer’s declaration – electromagnetic
immunity
Guidance and manufacturer’s declaration – electromagnetic immunity
The monitor is intended for use in the electromagnetic environment specified below. The customer or the user
of the monitor should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance
level
Electromagnetic environment - guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the equipment,
including cables, than the recommended separation
distance calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3 Vrms
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m
3.5
-----V1
P
3.5
-----E1
P
7
-----E1
P
80 MHz to 800
800 MHz to 2.5
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey, a
should be less than the compliance level in each
frequency range. b
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1
At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2
These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicated theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in
the location in which the equipment is used exceeds the applicable RF compliance level above, the
equipment should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the equipment.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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B40/B20 Patient Monitor
Table 4
Recommended separation distances between portable and mobile RF
communications equipment and the monitor
Recommended separation distances between portable and mobile RF
communications equipment and the monitor.
The monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the equipment can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the equipment as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum
output power of
transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
3.5
-----V1
P
80 MHz to 800 MHz
3.5
-----E1
P
800 MHz to 2.5 GHz
7
-----E1
P
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.74
1
1.17
1.17
2.33
10
3.69
3.69
7.38
100
11.67
11.67
23.33
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
NOTE 1
At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2
These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
A-4
Document no. 2081505-001
Installation and checkout form, B40/B20
APPENDIX B: Installation and checkout form,
B40/B20
Customer
Service
Service engineer
Date
Monitor license
MAC Address
License key
Modules
Entropy module:
Gas module:
OK = Test OK
Visual Inspection
N.A. = Test not applicable
Fail = Test failed
Expected result
Observed result
OK
N.A.
Fail
Expected result
Observed result
OK
N.A.
Fail
3.1. Visual inspection
Functional Inspection
3.2.1. Start-up
3.2.2. Display
3.2.3. Time and date
3.2.4. Parameters measurements
3.2.5. Recorder
3.2.6. MC or S/5 Network connection
3.2.7. Conclusion
B-1
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B40/B20 Patient Monitor
Functional Inspection
Notes
Signature
B-2
Document no. 2081505-001
Expected result
Observed result
OK
N.A.
Fail
Maintenance and checkout form, B40/B20
APPENDIX C: Maintenance and checkout form,
B40/B20
Customer
Service
Service engineer
Date
Monitor Installation
IBP:
SpO2 module:
Gas module:
Entropy module:
Network:
TEMP:
Measuring equipment used:
Equipment / tool:
Manufacturer:
OK = Test OK
Visual Inspection
Model/Type/Part
Number:
N.A. = Test not applicable
Serial Number /
ID:
Calibration
Date:
Fail = Test failed
Expected result
Observed result
OK
N.A.
Fail
Expected result
Observed result
OK
N.A.
Fail
4.1. Visual inspection
Notes
Electrical Safety Tests
2.2. Power Outlet Test
2.3. Power cord and plug
2.4. Ground (earth) integrity
Ground continuity test
Impedance of protective earth
connection
< 0.1 ohms/
< 0.2 ohms
< 0.1 ohms/
< 0.2 ohms
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B40/B20 Patient Monitor
Electrical Safety Tests
Expected result
Observed result
OK
N.A.
Fail
Observed result
OK
N.A.
Fail
2.5. Earth leakage current test
Normal Condition (NC)
Single Fault Condition (SFC)
< 500 µA
< 300 µA
< 1 mA
2.6. Enclosure (Touch) leakage
current test
Normal Condition (NC)
Single Fault Condition (SFC)
< 100 µA
< 500 µA
< 300 µA
2.7.1. Patient (source) leakage
current test
Normal Condition (NC)
< 10 µA
Single Fault Condition (SFC)
< 50 µA
2.7.2. Patient (sink) leakage current
tests
< 50 µA
Notes
Functional Inspection
4.2.1. Start-up
4.2.2. Display
4.2.3. Keyboard(s)
4.2.4. Time and date
Notes
4.2.5. Hemo Module
. ECG measurement
1. Normal Sinus Rhythm
2. Pacemaker Detection
3. Asystole Detection
4. Leads Off Detection
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Expected result
Maintenance and checkout form, B40/B20
Functional Inspection
Expected result
Observed result
OK
N.A.
Fail
Notes
. Respiration measurement
5. Respiration Rate
6. Apnea Detection
Notes
. Temperature measurement
7. Temperature detection
Notes
. Invasive blood pressure
measurement
8. Zeroing
9. Static Pressure
10. Pressure Waveforms
Notes
. SpO2 measurement
11. Test measurement
Notes
. Non Invasive Blood Pressure
measurement
12. NIBP Leak Test
13. NIBP calibration
14. NIBP hose detection
Notes
4.2.6. Loudspeaker
4.2.7. Monitor software
4.2.8. Watchdog circuitry
4.2.9. Network
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B40/B20 Patient Monitor
Functional Inspection
Expected result
Observed result
OK
N.A.
Fail
Expected result
Observed result
OK
N.A.
Fail
4.2.10. Final cleaning
Notes
Monitor battery maintenance
4.3.3. Test the battery charge
Notes
Used Spare Parts
Notes
Signature
C-4
Document no. 2081505-001
Appendix D, Service check form, E-miniC
APPENDIX D Service check form, E-miniC
Customer
Monitor
S/N
Service
Module type
S/N
Service engineer
Date
Measuring equipment / test gases used:
Equipment / tool / gas:
Manufacturer:
Model/Type/Part No:
Serial Number/ID:
Cal Due Date:
Prior to testing verify all equipment is calibrated via “Cal” labeling and record Cal Due Dates
OK = Test OK
Visual Inspection
N.A. = Test not applicable
Fail = Test failed
Expected result
Observed result
OK
N.A.
Fail
Expected result
Observed result
OK
N.A.
Fail
2.2. Visual inspections
Notes
Functional checkout
1. Gas sampling system leak test
2. Sample flow check
3. Zero valve operation
4. Gas calibration
5. Ambient pressure
6. Occlusion detection
7. Air leak detection
8. Airway gases
9. Apnea detection
D-1
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B40/B20 Patient Monitor
Functional checkout
Notes
Used spare parts
Signature
D-2
Document no. 2081505-001
Expected result
Observed result
OK
N.A.
Fail
Appendix E, Service check form, E-sCO, E-sCAiO and N-CAiO
APPENDIX E Service check form, E-sCO, E-sCAiO
and N-CAiO
Customer
Monitor
S/N
Service
Module type
S/N
Service engineer
Date
Measuring equipment / test gases used:
Equipment / tool / gas:
Manufacturer:
Model/Type/Part No:
Serial Number/ID:
Cal Due Date:
Prior to testing verify all equipment is calibrated via “Cal” labeling and record Cal Due Dates
OK = Test OK
Visual Inspection
N.A. = Test not applicable
Fail = Test failed
Expected result
Observed result
OK
N.A.
Fail
Expected result
Observed result
OK
N.A.
Fail
2.2. Visual inspections
Notes
Functional checkout
1. Gas Sampling System Leak Test
2. Sample Flow Rate Check
3. Reference Gas Flow Rate Check
4. Fan
5. Zero Valve Operation
6. Gas Calibration
7. Agent Identification
8. Ambient Pressure
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B40/B20 Patient Monitor
Functional checkout
9. Occlusion detection
10. Air Leak detection
11. Gas exhaust blockage
12. Airway Gases
13. Apnea detection
Notes
Used spare parts
Signature
E-2
Document no. 2081505-001
Expected result
Observed result
OK
N.A.
Fail
Appendix F, Service check form, E-Entropy
APPENDIX F Service check form, E-Entropy
Customer
Monitor
S/N
Service
Module type
S/N
Service engineer
Date
Measuring equipment / test gases used:
Equipment / tool / gas:
Manufacturer:
Model/Type/Part No:
Serial Number/ID:
Cal Due Date:
Prior to testing verify all equipment is calibrated via “Cal” labeling and record Cal Due Dates
OK = Test OK
Visual Inspection
N.A. = Test not applicable
Fail = Test failed
Expected Result
Observed Result
OK
N.A.
Fail
Expected Result
Observed Result
OK
N.A.
Fail
2.1. Visual inspections
Notes
Electrical Safety Tests
2.7.1. Patient (source) leakage
current test
Normal Condition (NC)
< 10 µA
Single Fault Condition (SFC)
< 50 µA
2.7.2. Patient (sink) leakage
current tests
using a test body
< 10 µA
using a patient cable
< 50 µA
Notes
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B40/B20 Patient Monitor
Functional Check
1. Module and sensor recognition
2. Sensor checking
3. Functional check with a
simulator
Notes
Used spare parts
Signature
F-2
Document no. 2081505-001
Expected Result
Observed Result
OK
N.A.
Fail
Appendix G, Networking disclosure to facilitate network risk managment
APPENDIX G Networking disclosure to facilitate
network risk managment
Purpose and scope
This disclosure is intended to satisfy the requirements of IEC 60601-1:2005 clause 14.13 and
IEC/ISO 80001-1:2010 clause 3.5 for disclosure of network related specifications, requirements
and residual risks in order to facilitate the responsible organization’s risk management
activities (e.g. pursuant to 80001-1) for their networks incorporating the B40 monitor.
Purpose for B40 monitor connection to network
• Providing realtime patient data (i.e. parameters, waveforms and alarms) to compatible
network devices such as central stations.
•
Remote configuration (patient admission, alarm settings, etc.) from compatible network
devices.
•
Printing to a compatible network printer.
Network interface technical specifications
Connection Name
Mission Critical (MC) network port
Physical network connection type
IEEE 802.3-1998 10/100BaseT Ethernet
Speeds and duplex modes supported
100 Mbps half and full duplex
Default IP address (from factory)
IP address: 172.16.X.X
Subnet Mask: 255.255.0.0
Gateway: 172.16.254.254
IP addressing
IPv4 static
Qos Support
IP layer DSCP tagging
Connection Name
S/5 network port
Physical network connection type
IEEE 802.3-1998 10/100BaseT Ethernet
Speeds and duplex modes supported
100 Mbps half and full duplex
Address
Virtual Plug ID
Network information flows
Flow Name
Realtime patient data
Network connection on device
MC network port, S/5 network port
Usage Type/Function/Purpose
Waveforms, parameters, trends, alarm
settings, admit/discharge patient
Licensed/optional/required
Licensed: Unity or S/5
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B40/B20 Patient Monitor
Communication partner Device/IP
address/network
MC: CIC, Aware Gateway, CARESCAPE
Gateway, Mobile Care Server
S/5: iCentral
Middle layer protocols
MC: UDP; S/5: DRI
Application layer protocol and encoding
MC: Unity; S/5: DRI
Ports
MC: 2000, 7000, 7001
Traffic characterization and bandwidth
requirements
MC: 50 Kbps streaming data per patient
view, 11 views maximum for wired network
S/5: Variable
Flow Name
Ping
Network connection on device
MC network port
Usage Type/Function/Purpose
Network troubleshooting and check
Licensed/optional/required
Required
Communication Partner Device/IP
address/network
PC, other medical devices
Middle layer protocols
ICMP
Application layer protocol and encoding
NA
Ports
NA
Traffic characterization and bandwidth
requirements
On-demand, user initiated
Flow Name
HL7
Network connection on device
MC network port
Usage Type/Function/Purpose
HL7 outbound to EMR system
Licensed/optional/required
Licensed
Communication Partner Device/IP
address/network
HL7 Server
Middle layer protocols
TCP
Application layer protocol and encoding
HL7
Ports
customer definded, default port is 6000
Traffic characterization and bandwidth
requirements
720 bps, on demand
Flow Name
Printing
Network connection on device
S/5 network port
Usage Type/Function/Purpose
Print
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Appendix G, Networking disclosure to facilitate network risk managment
Licensed/optional/required
Required
Communication Partner Device/IP
address/network
Printer
Middle layer protocols
DRI
Application layer protocol and encoding
PCL
Ports
NA
Traffic characterization and bandwidth
requirements
Max: 47 Kbps, Avg: 27 Kbps
Flow Name
Software Transfer
Network connection on device
MC network port
Usage Type/Function/Purpose
Performs software upgrades
Licensed/optional/required
Required
Communication Partner Device/IP
address/network
Service-PC
Middle layer protocols
TCP
Application layer protocol and encoding
HTTP
Ports
10001
Traffic characterization and bandwidth
requirements
10 Mbps
Required characteristics and configuration of network for support
• The network must meet the specific requirements above for all traffic flows associated
with the subset of features, use cases and workflows required by the responsible
organization’s users.
•
In addition, the network must be “flat” (i.e. limited to a single IP broadcast domain).
Potential risks to safety, effectiveness or security resulting from failure of IT
network to provide the required
Loss of network connectivity can result in the following hazardous situations:
−
Missed alarm at a remote viewing station (bedside or CIC).
−
Complete or partial loss or deterioration of remote monitoring of waveform and
parameter data at remote viewing device.
Product mitigations:
−
Low alarm volume is increased if network communication fails
−
Audio off, audio pause are interrupted if network communication fails
−
User is notified of network communication failure, message is displayed until user
acknowledges it
−
User is notified if a duplicate IP address is detected
−
User is notified if a duplicate unit/bed name
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B40/B20 Patient Monitor
In addition to the hazardous situations identified above, connection of the B40 monitor to a
network that includes other equipment could result in other unidentified risks to patients,
operators or third parties. The responsible organization should identify, analyze, evaluate and
control these risks on an ongoing basis including after changes to the network, which could
introduce new risks and require additional analysis.
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Document no. 2081505-001
GE Medical Systems
Information Technologies, Inc.
8200 West Tower Avenue
Milwaukee, WI 53223 USA
Tel:+ 1 414 355 5000
1 800 558 5120 (US only)
GE Medical Systems
Information Technologies GmbH
Munzingerstrasse 5
79111 Freiburg
Germany
Tel: + 49 761 45 43 - 0
GE Medical Systems Information Technologies, a General Electric Company, going to market as
GE Healthcare
www.gehealthcare.com
0459