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 Morgan Griffith (/user/22110771/)
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1
BeneView T8 Patient Monitor Service Manual
2
3 Intellectual Property Statement SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the
intellectual property rights to this product and this manual. This manual may refer to information protected by copyrights or patents
and does not convey any license under the patent rights of Mindray, nor the rights of others. Mindray does not assume any liability
arising out of any infringements of patents or other rights of third parties. Mindray intends to maintain the contents of this manual as
confidential information. Disclosure of the information in this manual in any manner whatsoever without the written permission of
Mindray is strictly forbidden. Release, amendment, reproduction, distribution, rent, adaption and translation of this manual in any
manner whatsoever without the written permission of Mindray is strictly forbidden., and are the registered trademarks or trademarks
owned by Mindray in China and other countries. All other trademarks that appear in this manual are used only for editorial purposes
without the intention of improperly using them. They are the property of their respective owners. Contents of this manual are subject
to changes without prior notice. Revision History This manual has a revision number. This revision number changes whenever the
manual is updated due to software or technical specification change. Contents of this manual are subject to change without prior
notice. Revision number: 1.1 Release time: April Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved. I
4
FOR YOUR NOTES II
5 Preface Manual Purpose This manual provides detailed information about the assembling, dissembling, testing and
troubleshooting of the equipment to support effective troubleshooting and repair. It is not intended to be a comprehensive, in-depth
explanation of the product architecture or technical implementation. Observance of the manual is a prerequisite for proper
equipment maintenance and prevents equipment damage and personnel injury. This manual is based on the maximum
configuration; Therefore, some contents may not apply to your monitor. If you have any question, please contact our Customer
Service Department. Intended Audience This manual is for biomedical engineers, authorized technicians or service representatives
responsible for troubleshooting, repairing and maintaining the patient monitors. III
6 Abbreviations Abbreviations used in this manual are: MPM SMR CMS PCB multi-parameter module satellite module rack central
monitoring system printed circuit board Passwords A password may be required to access different modes within the monitor. The
passwords are listed below: User maintenance: Factory maintenance: Demo mode: 2088 IV
7 Contents 1 Safety Safety Information DANGER Warnings Cautions Notes Equipment Symbols Theory of Operation Introduction
System Connections Mounting the Patient Monitor Connectors for Peripheral Devices Main Unit Input System Output System
Processing and Communications System Power Management System Equipment Interface System Parameter Module Module
Infrared Communication Board Module Power Board Parameter Board Satellite Module Rack Testing and Maintenance Introduction
Test Report Recommended Frequency Visual Test Power On Test Module Performance Tests Mainstream CO 2 Tests Sidestream and
Microstream CO 2 Module Test ECG Tests Resp Performance Test NIBP Tests IBP Tests
8 3.4.7 SpO 2 Test C.O. Test Temp Test BIS Test RM Test ICG Test AG Tests Nurse Call Relay Performance Test Analog Output
Performance Test Electrical Safety Tests Enclosure Leakage Current Test Earth Leakage Current Test Patient Leakage Current Test
Patient Auxiliary Leakage Current Test Touchscreen Calibration Recorder Check Factory Maintenance Accessing Factory Maintenance
Menu Drawing Waves Recorder Software Version Monitor Information Calibrate NIBP Program Upgrade Troubleshooting Introduction
Part Replacement Patient Monitor Status Check Software Version Check Technical Alarm Check Troubleshooting Guide Power On/Off
Failures Display Failures Module Rack Failures Alarm Problems Button and Knob Failures Recorder Failures Interface Failures CF Card
Problems Power Supply Failures Network Related Problems Software Upgrade Problems
9 5 Repair and Disassembly Tools Preparations for Disassembly Basic Disassembly Disconnecting the Base Separating the Front and
Rear Half of the Monitor Further Disassembly Removing the Power Switch & LED Board Disconnecting the Knob Encoder Removing
the Button Board Removing the LCD Assembly Removing the Alarm Lamp Board Removing the Main Board Removing the CF/WLAN
Assembly Removing the Fan Removing the Speaker Removing the Interface Board Assembly Removing the Power Supply Assembly
Removing the Integral Module Rack Removing the Recorder Removing the wireless AP Removing the SMR Assembly Disassembling
Modules Disassembling the ICG Module Disassembling CO 2 Module Parts Introduction Main Unit Base Assembly Front housing
Assembly LCD with Anti-glare Screen LCD Touchscreen Rear Housing Assembly Rear Housing Assembly Power module Integral
Module Rack Interface Board Assembly Main Support Assembly Others SMR Assembly SMR Assembly SMR Inside Assembly
Parameter Modules
10 6.7.1 MPM Module C.O. Module RM Module ICG Module AG Module BIS Module IBP Module Mindray CO2 Module Oridion CO2
Module Wireless AP Replaceable Parts Main Unit SMR Parameter Modules Cables
11 1 Safety 1.1 Safety Information DANGER Indicates an imminent hazard that, if not avoided, will result in death or serious injury.
WARNING Indicates a potential hazard or unsafe practice that, if not avoided, could result in death or serious injury. CAUTION
Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury or product/property damage.
NOTE Provides application tips or other useful information to ensure that you get the most from your product. 1-1
12 1.1.1 DANGER There are no dangers that refer to the product in general. Specific Danger statements may be given in the
respective sections of this manual Warnings WARNING All installation operations, expansions, changes, modifications and repairs of
this product are conducted by Mindray authorized personnel. There is high voltage inside the equipment. Never disassemble the
equipment before it is disconnected from the AC power source. When you disassemble/reassemble a parameter module, a patient
leakage current test must be performed before it is used again for monitoring. The equipment must be connected to a properly
installed power outlet with protective earth contacts only. If the installation does not provide for a protective earth conductor,
disconnect it from the power line and operate it on battery power, if possible. Dispose of the package material, observing the
applicable waste control regulations and keeping it out of children s reach Cautions CAUTION Make sure that no electromagnetic
radiation interferes with the performance of the equipment when preparing to carry out performance tests. Mobile phone, X-ray
equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation. Before
connecting the equipment to the power line, check that the voltage and frequency ratings of the power line are the same as those
indicated on the equipment s label or in this manual. Protect the equipment from damage caused by drop, impact, strong vibration
or other mechanical force during servicing. 1-2
13 1.1.4 Notes NOTE Refer to Operation Manual for detailed operation and other information. 1.2 Equipment Symbols Attention:
Consult accompanying documents (this manual). Danger: High-voltage CIS connector Network connector Alternating current(ac)
Power ON/OFF Battery indication Defibrillator connector Connector for satellite module rack Video output Zero key Auxiliary output
connector Calibrate key USB connector Measure/Standby Equipotential terminal Check sensor CE marking ESD warning symbol for
Electrostatic sensitive devices. Type CF applied part. Defibrillator-proof protection against electric shock. Type BF applied part.
Defibrillator-proof protection against electric shock. 1-3
14
FOR YOUR NOTES 1-4
15 2 Theory of Operation 2.1 Introduction This patient monitor is designed to monitor a fixed set of physiological parameters
including ECG, heart rate (HR), respiration (Resp), temperature (Temp), SpO 2, pulse rate (PR), non-invasive blood pressure (NIBP),
invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO 2 ), oxygen (O 2 ), anesthetic gas (AG), impedance cardiograph
(ICG), bispectral index (BIS) and respiration mechanics (RM) of single adult, pediatric and neonatal patients. The patient monitor also:
Provides audible and visual alarm indications in case of patient or equipment problems. Enables displaying, reviewing, storing and
transferring of real-time data. Incorporates multiple input devices such as buttons, knob, touchscreen, keyboard and mouse.
Interfaces a clinical information system or central monitoring system. Enables program upgrade over the network. 2-1
16 2.2 System Connections Mounting the Patient Monitor The patient monitor can be mounted on a wall bracket or on a trolley
support. The wall bracket or trolley support can be ordered optionally. Each type of mounting bracket is delivered with a complete set
of mounting hardware and instructions. Refer to the documentation delivered with the mounting hardware for instructions on
assembling mounts. CAUTION Use mounting brackets we supply or approve. If other compatible mounting bracket is used, be sure it
can be safely used on the patient monitor. The mounting bracket should be installed by our qualified service personnel, or engineers
who have adequate knowledge on it. If other mounting solution is used, the installation personnel and the customer should verify if it
can be safely used on the patient monitor, and the customer assume the responsibility for any risk resulting from that. 2-2
17 2.2.2 Connectors for Peripheral Devices On the back of the patient monitor you will find all connectors for peripheral devices AC
Power Connector: used to connect an AC power source (100 to 240 VAC, 50/60Hz). 2. Equipotential Terminal: used to connect the
equipotential terminal of other equipment, eliminating potential difference between different pieces of equipment. 3. SMR
Connector: It outputs a 12V DC, used to connect the SMR. 4. Video Output: It is a DVI-D connector used to connect a secondary
display. 5. CIS Connector: It is a RJ45 connector used to connect a CIS. 6. Network Connector: It is a RJ45 connector used to connect an
ethernet network or a PC. 7. Defibrillator Connector: It is a RJ11 connector used to connect a defibrillator. 8. Auxi Output Connector: It
is a BNC connector used to output analog signals and nurse call signals. 9. Secondary USB Connector: used to connect the mouse and
keyboard of the secondary display. 10. General USB Connector: used to connect any USB-compatible peripheral device. 2-3
18 2.3 Main Unit The patient monitor consists of: Input system: button board, knob, touchscreen, power switch and LED board
Output system: LCD panel, alarm LED board, recorder, speaker Processing and communications system: main board, CIS assembly,
integral module rack Power management system: battery, battery interface board, power module Equipment interface system: USB
interface board, DVI interface board and CF/WLAN assembly. Additionally, the patient monitor can also connect a satellite module
rack (SMR), parameter modules, mouse, keyboard, etc. The following diagram illustrates the structure of the patient monitor. 2-4
19 2.3.1 Input System Button board The button board, located at the lower part of the monitor s front panel, contains 6 keys and
provides connections for the following components to the main board: Knob Power switch & LED board Touchscreen control board
Backlight board Alarm LED board The following diagram shows the button board connections. Knob The knob can be pressed, or
rotated both clockwise and counter-clockwise. It is connected with the button board. Touchscreen The touchscreen enables touch
operations and can be calibrated. It is connected with the touchscreen control board and main board. Power switch & LED Board The
power switch & LED board controls the power supply for the main unit. It has three LEDs, which respectively indicate the AC power
status, battery status and monitor power on/off status. It is connected with the button board. 2-5
20 2.3.2 Output System LCD The patient monitor adopts a high-resolution LCD. The LCD is connected with the main board. The
signals and power supply from the backlight board are transferred by the button board. Alarm Lamp The patient monitor has two
alarm lamps: physiological alarm lamp and technical alarm lamp. Physiological alarm lamp lights either red or yellow whereas
technical alarm lamp lights blue only. The alarm lamp signals are transferred by the button board and are directly controlled by the
main board Recorder The recorder receives data coming form the main board and then sends them to the thermal printhead for
printing. The recorder has a hardkey (starting/stopping recordings) and a green LED on its front. It is connected with the main board.
The following diagram shows its operating principle. 2-6
21 Module Power interface Power module CPU Signal interfac Motor drive circuit Button & LED board Description Introduces a DC
from the main board. Converts the input power into voltages that fit each module and then forwards them to each module. Control
the communications between modules. Control the communications between the main board and the recorder CPU. Receives the
control signals from the CPU and then forwards them to the step engine.s Includes one button and one LED which are directly
controlled by the CPU. Speaker The speaker provides sound for alarms, key strokes, heart beats and pulse, and allows PITCH TONE
and multi-level tone modulation. It is connected with the main board and is directly driven by the main board Processing and
Communications System Main Board The main board is the heart of the patient monitor. It implements a series of tasks including
input & output control, data storage and processing, display processing, system control, communication management, printing
management and alarming, etc. The main board comprises the CPU board and mother board. The following diagram shows
interfaces to other components. 2-7
22 The CPU board is an essential CPU system containing the CPU, FLASH, memory, realtime clock, EEPROM, etc. It interfaces to the
mother board only, which then provides interfaces to all other external devices. The mother board is in charge of connections and
communications with other components and provides the following interfaces: LCD port: connects a built-in display. Video
output+network+ GPIO: connects the digital video interface board. USB 2+RS422: connects the USB interface board. Button board
port: connects the button board. Integral module rack port: connects integral module rack communication board. Fan port: connects
the fan. Speaker port: connects the speaker. Power module port: connects the power module. CIS port: located at the back of the
mother board for connecting the CIS components. WLAN&CF port: connects the CF/ WLAN assembly. Recorder port: connects the
recorder. 2-8
23 Integral Module Rack The patient monitor has two kinds of integral module rack: 2-slot and 5-slot. The integral module rack
consists of control board and communication board. The control board is a NIOS II module embedded in the communication board. It
implements protocol conversion and infrared communication between the main unit and the parameter modules. The module rack
communication board can be a 2-slot type or a 3-slot type. The 3-slot communication board has an embedded NIOSII control board
and communicates the main board directly. The 2-slot communication board is connected with the 3-slot communication board and
is controlled by the NIOSII board. Both types of communication board consist of the infrared circuit and module power circuit. The
RS422 drive circuit is located on the 3-slot communication board Power Management System Battery The patient monitor uses two
chargeable lithium-ion batteries (11.1 V, 4500 mah). The battery compartment door is located at the bottom of the patient monitor.
The battery power is introduced to the power module via the battery interface board, and then processed and distributed to each
component by the power module. NOTE Two batteries must be used simultaneously when the patient monitor operates on battery
power. Otherwise, it may cause power supply protection. Battery Interface Board The battery interface board connects batteries to
the power module, enabling charging and discharging between the batteries and the power board. 2-9
24 Power Module The power module is located at the back of the patient monitor. The main part of the power module is the power
board, which contains 4 PCBs: charging & power management board, voltage drop DC inverter, voltage rise and drop DC inverter, and
voltage drop 5 V CIS power board. The power module transforms the input power into DC and then forwards them to each
component of the patient monitor. The input power comes from either the batteries or an AC source. The patient monitor will run
power from the AC source whenever an AC source is available. If the AC source becomes unavailable, the patient monitor will
automatically switch to the battery power. This does not affect the monitor s operating status. Power module has an AC input socket
at its backside, and a socket at its front provides 4 connections to the batteries, main board, CIS components and USB interface board
respectively. The power module protects itself and the patient monitor by switching off AC input or DC output in case of overcurrent,
short circuit and overvoltage.the power module provides 4 DC outputs: Outputs +3.3 V +5.0 V Description Goes to the mother board,
CPU board, DVI interface board and integral module rack. Goes to the LCD, DVI interface board, recorder, CF storage card board and
USB interface board V CIS Goes to the CIS assembly. +12 V Goes to the recorder, LCD inverter, integral module rack, parameter
modules and USB interface board. The systematic principle diagram of the power module is as follows: 2-10
25 The following diagram shows the pins of the power module socket (excluding the pins of the battery power socket. On power
board, pin 1 has a triangle symbol): Pin ID Marking Description Cable color 2, 4, 6, 7, 13, 15, 17 GND The output grounding terminal of
the power board. Black 8 RXD Receives serial communications (the main board sends). Purple 9 TXD Sends serial communications
(the main board receives). Brown 10 PCON 11 LCD-EN 12, 1 12 V 14, 3 5 V CIS 16, 5 5 V 18, V Power on/off control signal. It is a TTL
pulse signal inputted from the back board. Every time when the power on/off switch is pressed (pulse of falling edge), a switch
between power on and off happens. The pulse duration is no less than 0.1 s for power-on and no less than 2 s for power off. Backlight
on/off control signal. The main board sends a backlight on/off control signal to the power board through the serial interface. The
power board processes the received signal and then outputs a high or low level depending on the received signal. The positive end of
the 12 V DC coming from the power board. The positive end of the 5 V CIS coming from the power board. The positive end of the 5 V
DC coming from the power board. The positive end of the 3.3 V DC coming from the power board. Blue Green Yellow Purple Red
Orange 20 LED- AC AC power status indication signal White 21 LED- BAT Battery status indication signal. Grey 22 LCD-BR Backlight
brightness control voltage. Brown 2-11
26 2.3.5 Equipment Interface System USB Interface Board The USB interface board is compatible with such USB interfaces as USB2.0,
USB1.1 and USB1.0. It is connected with the main board and the power module. It receives 2 USB differential signals coming from the
main board and then distributes them to 10 USB interfaces via 2 ISP1521 chips. Moreover, it provides RS232 and RS422 interfaces for
communication between the main board and the SMR. The USB interface board receives 5 VDC and 12 VDC inputs from the power
module, of which the 5 VDC goes to the USB interface board and the 12 VDC outputted to the SMR connector through a fuse. 2-12
27 DVI Interface Board The DVI interface board is connected with the mother board and the CIS mother board. The following
diagram shows its interfaces to other components. Interface CIS Connector BNC connector RJ 11 connector RJ 45 connector (network)
RJ 45 connector (CIS) DVI-D connector Description Connects the CIS mother board. Outputs analog signals and nurse call signals.
Outputs defibrillator synchronization signals. It is a standard RJ45 connector, providing 10/100 BASE-TX Ethernet communications
channels. It connects an Ethernet network or a PC. It is a standard RJ45 connector for connecting a CIS network. Connects a secondary
display. WLAN&CF assembly The CF assembly serves the non-volatile CF storage card which is used for data storage and transfer. It is
connected with the mother board. 2-13
28 2.4 Parameter Module Each parameter module consists of the module infrared communication board, module power board,
module button board, parameter board, etc Module Infrared Communication Board The module infrared communication board
allows a short delay when powering up the module and adopts FPGA to enable infrared communications between the module and
the module rack. An ID is integrated into the module infrared communication board. When a module is inserted in the module rack,
the ID is automatically sent to the module rack Module Power Board Some modules have no power board. There are two kinds of
module power board: 1. Isolated power board: converts the 12 V DC into a 12 V isolated DC and a 5 V isolated DC. 2. Non-isolated
power board: converts the 12 V DC into a 5 V DC Parameter Board The parameter board is a parameter measurement component,
which is the most important component of the parameter module. 2-14
29 2.5 Satellite Module Rack The satellite module rack (SMR) is independent of the patient monitor, provides 8 slots for mounting
parameter modules. It has the following features: It allows a parameter module to be plugged and unplugged with the patient
monitor on. This allows function extension and patient transfer. It does not have its own power. It introduces 12 V DC from the
patient monitor and then supplies power to each parameter module via the contact screw. It accomplishes communications protocol
conversions between the patient monitor and each parameter module, provides infrared communications for parameter modules,
and is responsible for detecting infrared communications malfunction for each parameter module. The following diagram shows the
structure of the SMR. 2-15
30
FOR YOUR NOTES 2-16
31 3 Testing and Maintenance 3.1 Introduction To ensure the patient monitor always functions normally, qualified service personnel
should perform regular inspection, maintenance and test. This chapter provides a checklist of the testing procedures for the patient
monitor with recommended test equipment and frequency. The service personnel should perform the testing and maintenance
procedures as required and use appropriate test equipment. The testing procedures provided in this chapter are intended to verify
that the patient monitor meets the performance specifications. If the patient monitor or a module fails to perform as specified in any
test, repairs or replacement must be done to correct the problem. If the problem persists, contact our Customer Service Department.
CAUTION All tests should be performed by qualified service personnel only. Care should be taken to change the settings in [User
Maintenance] and [Factory Maintenance] menus to avoid loss of data. Service personnel should acquaint themselves with the test
tools and make sure that test tools and cables are applicable. 3-1
32 3.1.1 Test Report After completing the tests, service personnel are required to record test results in this table and report them to
Mindray Customer Service Department. Test Equipment Name Model/PN Expiry Date Test Record No. Test Item Test Site Test Results
1 2 Conclusion Pass/Fail: Tested by: Date: Recommended Frequency Check/Maintenance Item Visual test Power on test Frequency 1.
When first installed or reinstalled. 1. When first installed or reinstalled. 2. Following any maintenance or the replacement of any main
unit parts. Mainstream CO 2 test Sidestream and Microstream CO 2 tests ECG tests / Leakage test Calibration Performance test
Calibration 1. If user suspects that the measurement is incorrect. 2. Following any repairs or replacement of respective module. 3. At
least once every two years. Resp test / NIBP tests Accuracy test Leakage test Calibration 3-2
33 IBP tests Performance test Pressure calibration SpO 2 test / C.O. test / Temp test / BIS test / RM test / ICG test / AG tests Nurse call
relay performance test Analog output performance test Electrical safety tests Performance test Calibration / / Enclosure leakage
current test Earth leakage current test Patient leakage current test Patient auxiliary current test 1. If user suspects that the
measurement is incorrect. 2. Following any repairs or replacement of AG module. 3. At least once every year If user suspects that the
nurse call or analog output does not work well. 1. Following any repair or replacement of the power module. 2. At least once every
two years. Touchscreen calibration / 1. When the touchscreen appears abnormal. 2. After the touchscreen is replaced. Recorder
check / Following any repair or replacement of the recorder. 3.2 Visual Test Inspect the equipment for obvious signs of damage. The
test is passed if the equipment has no obvious signs of damage. Follow these guidelines when inspecting the equipment: Carefully
inspect the case, the display screen and the buttons for physical damage to Inspect the SMR and parameter modules for mechanical
damage. Inspect all external connections for loose connectors, bent pins or frayed cables. Inspect all connectors on the equipment
for loose connectors or bent pins. Make sure that safety labels and data plates on the equipment are clearly legible. 3-3
34 3.3 Power On Test This test is to verify that the patient monitor can power up correctly. The test is passed if the patient monitor
starts up by following this procedure: 1. Insert two batteries in the battery chamber and connect the patient monitor to the AC mains,
the AC mains LED and battery LED light. 2. Press the power on/off switch to switch on the patient monitor. The operating status LED
lights up, and the technical and physiological alarm lamps light blue and red respectively. 3. After the start-up screens are displayed,
the system sounds a beep indicating the self test on alarm sounds is passed. At the same time, the technical alarm lamp turns yellow,
and then turns off together with the physiological alarm lamp. This indicates that the self test on alarm lamps is passed. 4. The
patient monitor enters the main screen and start-up is finished. 3.4 Module Performance Tests Mainstream CO 2 Tests Follow this
procedure to perform the test: 1. Connect the mainstream CO 2 module with the sensor and plug the module in the module rack. 2.
Enter the [CO2 Setup] menu to set [Operating Mode] to [Measure]. Wait for CO 2 module warmup. 3. Select [Start Zero Cal.] in the
[CO2 Setup] menu. If zero calibration fails, the prompt information [CO2 Zero Failed] is displayed. If it passes, the baseline of
waveform returns to zero. 4. Set [Apnea Time] to 10 s in the [Adjust CO2 Limits] menu. 5. Blow to the CO 2 sensor to generate a CO 2
waveform. Hold the sensor for 10 s and the alarm message [CO2 Apnea] is displayed on the screen. 6. Disconnect the CO 2 sensor,
verify that prompt information [CO2 Comm Stop] is displayed. 3-4
35 3.4.2 Sidestream and Microstream CO 2 Module Test Leakage test Follow this procedure to perform the test: 1. Plug the module
in the module rack. 2. Enter the [CO2 Setup] menu to set [Operating Mode] to [Measure]. Wait for CO 2 module warmup. 3. Block the
gas inlet completely. Sidestream: Check that alarm message [CO2 FilterLine Err] is displayed on the screen in 3s. Block the gas inlet for
another 30s, if the alarm message does not disappear, the module does not leak. Microstream: Check that alarm message [CO2
Purging] is displayed on the screen in 3s. Block the gas inlet for another 30s, if alarm message [CO2 FilterLine Err] is shown, the
module does not leak. Calibration Tools required: A gas bottle with 5% CO 2 gas T-shape connector Tubing Follow this procedure to
perform a calibration: 1. Make sure that the CO 2 module has been warmed up or started up. 2. Select [Main Menu] [Maintenance >>]
[User Maintenance >>] enter the required password [Maintain CO2 >>]. 3. In the [Maintain CO2] menu, select [Zero]. 3-5
36 4. Connect the gas bottle with the tubing using a T-shape connector as shown below. Check the airway and make sure there are
no leaks. Open to the air Gas valve Tubing Monitor Gas bottle 5. Vent the tubing to the CO 2 opening the gas valve. 6. In the [Calibrate
CO2] menu, enter the vented CO 2 concentration in the [CO2] field. 7. In the [Maintain CO2] menu, the measured CO 2 concentration,
barometric pressure, sensor temperature and current flowrate are displayed. After the measured CO 2 concentration becomes
stable, select [Calibrate CO2] to calibrate the CO 2 module. 8. If the calibration is finished successfully, the message [Calibration
Completed!] is displayed. If the calibration failed, the message [Calibration Failed!] is displayed. Perform another calibration ECG Tests
ECG Performance Test Tool required: Patient simulator 1. Connect the patient simulator to the ECG/Resp connector on the module. 2.
Set HR output to 80 bpm in the ECG simulator. 3. The displayed HR value should be 80 ± 1 bpm for 3- and 5-lead ECG monitoring, 80 ±
2 bpm for 12-lead ECG monitoring. 3-6
37 ECG Calibration The ECG signal may be inaccurate due to hardware or software problems. As a result, the ECG wave amplitude
becomes greater or smaller. In that case, you need to calibrate the ECG module. 1. Select the ECG parameter window or waveform
area [Filter] [Diagnostic]. 2. Select [Main Menu] [Maintenance>>]. 3. Select [Calibrate ECG]. A square wave appears on the screen and
the message [ECG Calibrating] is displayed. 4. Compare the amplitude of the square wave with the wave scale. The difference should
be within 5%. You can also print out the square wave and the wave scale if necessary Resp Performance Test Tool required: Patient
simulator 1. Connect the patient simulator to the Resp connector on the module. 2. Configure the simulator as follows: base
impedance line 1500 Ω; delta impedance 0.5 Ω, respiration rate 40 rpm. 3. The displayed Resp value should be 40 ± 2 rpm. 3-7
38 3.4.5 NIBP Tests NIBP Accuracy Test Tools required: T-shape connector Approprating tubing Balloon pump Metal Vessel with
volume 500 ± 25 ml Reference manometer with accuracy 1 mmhg Monitor Manometer Connector for NIBP cuff Tubing Balloon pump
Metal vessel Follow this procedure to perform the test: 1. Connect the equipment as shown above. 2. Before inflation, the reading of
the manometer should be 0. If not, disconnect the airway and reconnect it unit the readings is Select [Main Menu] [Maintenance >>]
[NIBP Accuracy Test]. 4. Compare the manometer values with the displayed values. The difference between the manometer and
displayed values should be no greater than 3 mmhg. 5. Raise the pressure in the metal vessel to 50 mmhg with the balloon pump.
Repeat step 3 and Raise the pressure in the metal vessel to 200 mmhg with the balloon pump. Repeat step 3 and 4. NOTE You can
use an NIBP simulator to replace the balloon pump and the reference manometer to perform the test. 3-8
39 NIBP Leakage Test Tools required: NIBP cuff for adult patient Approprating tubing Cylinder Follow this procedure to perform the
test: 1. Set [Patient Category] to [Adult]. 2. Connect the NIBP cuff with the NIBP connector on the moduel. 3. Apply the cuff to the
cylinder as shown below. 4. Select [Main Menu] [Maintenance>>] [NIBP Leakage Test]. The message [Leakage Testing ] is displayed in
the NIBP parameter area. 5. The cuff automatically deflates in 20s which means NIBP leakage test is completed. 6. If the system does
not leak, no message is displayed in the NIBP parameter area. If it leaks, the message [NIBP Pneumatic Leak] is displayed. In this case,
check for loose connection and perform the test again. Monitor Cylinder Connector for NIBP cuff Air tubing Cuff 3-9
40 NIBP Calibration Tools required: T-shape connector Approprating tubing Balloon pump Metal Vessel with volume 500 ± 25 ml
Reference manometer with accuracy 1 mmhg 1. Connect the equipment as shown below. 2. Before inflation, the reading of the
manometer should be 0. If not, disconnect the airway and reconnect it unit the readings is Select [Main Menu] [Maintenance >>]
[Factory Maintenance >>] enter the required password [Calibrate NIBP >>]. 4. Set [NIBP Pressure] to 150 mmhg in the [NIBP
measurement circuit]. Raise the pump output to 150 mmhg. After the pressure value is stabilized, select the [Calibrate] button to start
the calibration. 5. Set patient category to [Adu/Ped] in the [overpressure protection circuit], raise the pressure to 330 mmhg. Then,
select [Calibrate] to start the calibration. 6. Set the patient category to [Neo] in the [overpressure protection circuit], raise the
pressure to 165 mmhg. Then, select [Calibrate] to start the calibration. 7. Calibration result is displayed in the [Calibrate NIBP] menu.
If calibration fails, Check the system connection and perform calibration test again. 3-10
41 3.4.6 IBP Tests IBP Performance Test Tool required: Patient simulator 1. Connect the patient simulator to the pressure connector
on the module. 2. Set the pressure value of patient simulator to Press the Zero Key on the module to start a zero calibration. 4.
Configure the patient simulator as P(static)=200 mmhg. 5. The displayed value should be 200 ± 2 mmhg. 6. If the value is beyond
tolerance, calibrate the pressure module. 3-11
42 IBP Pressure Calibration Tools required: Standard sphygmomanometer Balloon pump Tubing T-shape connector 1. Connect the
equipment as shown below Pressure transducer 3-way stopcock T-shape connector Pressure adapter cable Manomete IBP module 2.
Zero the transducer. After a successful zero, open the stopcock to the manometer. 3. Select [Main Menu] [Maintenance >>] [Cal. IBP
Press. >>]. In the [Cal. IBP Press.] menu, enter calibration values for calibrated pressures. 4. Inflate using the balloon pump until the
mercury in the manometer reaches to the preset calibration pressure value. 5. Adjust the preset calibration value until it equals to the
reading on the manometer. 6. Select the [Calibrate] button to the right of the calibrated pressure. The monitor starts a calibration. 7.
If the calibration is completed successfully, the message [Calibration Completed!] will be displayed. If not, respective message will be
displayed. 3-12
43 3.4.7 SpO 2 Test Tool Required: Patient simulator. 1. Connect the patient simulator to the SpO 2 connector on the MPM. 2. Select
the model and the manufacturer of the SpO 2 module under test, and then configure the patient simulator as follows: SpO 2 96%; PR
80 bpm. 3. The displayed SpO 2 and PR values should be within the ranges listed below. SpO 2 PR (bpm) Mindray 96% ± 2% 80 ± 3
Masimo 96% ± 2% 80 ± 3 MAX-A, MAX-AL, MAX-N, MAX-P, MAX-I, MAX-FAST 96% ± 2% Nellcor OxiCliq A, OxiCliq N, OxiCliq P, OxiCliq I
96% ± 2.5% D-YS, DS-100A, OXI-A/N, OXI-P/I 96% ± 3% MAX-R, D-YSE, D-YSPD 96% ± 3.5% 80 ± C.O. Test Tool required: Patient
simulator 1. Connect the patient simulator to the C.O. connector on the module. 2. Set the patient simulator to output blood
temperature (BT) 37ºC. The displayed temperature value should be 37 ± 0.1ºC Temp Test Tool required: Resistance box 1. Connect the
two pins of any Temp connector on the module to the two ends of the resistance box using 2 wires. 2. Set the resistance box to
Ω(corresponding temperature is 37ºC). The displayed value should be 37 ± 0.2ºC. 3-13
44 BIS Test 1. Connect the BIS sensor with a normal and wide awake person as directed in the Operation Manual. 2. The displayed
BIS value should be higher than RM Test Tool required: Gas source Ventilator (calibrated) Artificial lung Flow sensor Monitor Ventilator
Flow sensor Artificial lung Follow this procedure to check the performance of RM module: 1. Connect the equipment as shown above.
Make sure that the blue sensing tube on the flow sensor is connected with the artificial lung. 2. Set [Patient Category] to [Adult]. Enter
[RM Setup] menu to select [Sensor Type] and set [Ventilation Mode] to [Mechanical]. 3. Calibrate the flow sensor. 4. Configure the
ventilator or anesthetic machine as follows: TV 500 ml, respiration rate =20 rpm, I:E=1:2. 5. Select [Respiratory Loop] in the [RM Setup]
menu. Verify that displayed value meets product specification. 3-14
45 ICG Test Tool required: Patient simulator 1. Connect the patient simulator, ICG sensor and the patient monitor using standard ICG
cable. 2. Select [ICG setup] [Patient Demographics >>] input parameter values as follows: Height 173 cm CVP 6 mmhg Weight 75 kg
PAmean 8 mmhg LV_D 50 mm Art Mean 93 mmhg PAWP 10 mmhg 3. Switch the patient simulator to Mode 1 and then start ICG
measurements. 4. After the measurement becomes stable, document the measured values. 5. Switch the patient simulator to mode 2
and then start ICG measurements. After the measurement becomes stable, document the measured values. 6. Check that measured
values meet the simulator configuration AG Tests AG Performance Test Tool required: Gas bottle with a certain standard anesthetic
gas. Gas concentration should meet AA>1.5%, of which AA represents an anesthetic agent T-shape connector Tubing 1. Plug the AG
module in the module rack. Enter [AG Setup] menu and set [Operating Mode] to [Measure]. 2. After the AG module warmup is ready,
block the gas inlet of the AG module. Alarm message [AC Airway Occluded] is displayed. 3. Connect the equipment as shown below. 4.
Open and close the gas valve repeatedly at an interval of 3 seconds. The AA value displayed should meet product specification. 3-15
46 BIS Performance Test The AG module can incorporates the features of the BIS module, refer to BIS Test for test procedures. O 2
Performance Test Tool required: Gas bottle with 100% O 2 T-shape connector Tubing The AG module can incorporates the features of
the O 2 module, refer to AG Performance Test above for test procedures. AG Calibration Tools required: Gas bottle, with a certain
standard gas or mixture gas. Gas concentration should meet the following requirements: AA>1.5%, CO 2 >1.5%, N 2 O>40%, O 2
>40%, of which AA represents an anesthetic agent. T-shape connector Tubing Reservoir bag Follow this procedure to perform the
calibration: 1. Select [Main Menu] [Maintenance >>] [User Maintenance >>] enter the required password [Calibrate AG >>]. 2. Check
the airway and make sure that there are no occlusions or leaks. Vent the sampling tubing to the air and check if the [Current
FlowRate] and [Set FlowRate] are approximately the same. If the deviation is great, it indicates that there is an occlusion in the tubing.
Check the tubing for an occlusion. Block the gas inlet of the tubing. The [Current FlowRate] shall fall rapidly and the system prompt
that the tubing is blocked. Otherwise, it indicates that there are leakages in the tubing. Check the tubing for leakages. 3-16
47 3. Connect the gas bottle, reservoir bag and the tubing using a T-shape connector as shown in the figure below. Gas valve Tubing
AG module Reservoir Gas bottle 4. Open the gas valve and vent a certain standard gas or mixture gas. 5. In the [Calibrate AG] menu,
the concentration and flowrate of each measured gas are displayed. If the difference between the measured gas concentration and
the actual one is tolerable, a calibration is not needed. If the difference is great, a calibration should be performed. Select [Calibrate
>>] to enter the calibrate menu. 6. Enter the vented gas concentration. If you use only one gas for calibration, set other gases
concentration to Select [Start] to start calibration. 8. If the calibration is finished successfully, the message [Calibration Completed!] is
displayed. If the calibration failed, the message [Calibration Failed!] is displayed. Perform another calibration. 3-17
48 3.5 Nurse Call Relay Performance Test Tools required: Multimeter 1. Connect the nurse call cable to the Auxiliary Output
Connector of the patient monitor. 2. Enter Demo mode. Select [Main Menu] [Maintenance >>] [User Maintenance >>] enter the
required password [Others >>] [Auxiliary Output] [Nurse Call]. 3. Select [Main Menu] [Maintenance >>] [User Maintenance >>] enter
the required password [Others >>] [Nurse Call Setup >>]. Enable all alarm level and alarm type options. Set [Contact Type] to
[Normally Open] 4. In [Nurse Call Setup >>] setup menu, set [Signal Type] to [Pulse]. Trigger an alarm and measure the output contact
with the multimeter. The output should be square waves with an interval of 1s. 5. In [Nurse Call Setup >>] setup menu, set [Signal
Type] to [Continuous]. Trigger an alarm and measure the contact output with the multimeter. The output should be continuous high
level. 3.6 Analog Output Performance Test Tool required: Oscillograph 1. Connect the oscillograph to the Auxiliary Output Connector
of the patient monitor. 2. Enter Demo mode. Select [Main Menu] [Maintenance >>] [User Maintenance >>] enter the required
password [Others >>] [Auxiliary Output] [Analog Output]. 3. Select [Main Menu] [Analog Output Setup]. Switch Analog Output [On],
and then test the ECG and IBP signals from the Analog Output Connector. 4. The waveforms displayed on the oscillograph should
closely resemble those displayed on the patient monitor. 3-18
49 3.7 Electrical Safety Tests WARNING Electrical safety tests are a proven means of verifying the electrical safety of the patient
monitor. They are intended for determining potential electrical hazards. Failure to find out these hazards timely may cause personnel
injury. Commercially available test equipment such as safety analyzer, etc. can be used for electrical safety tests. Be sure that the test
equipment can be safely and reliably used with the patient monitor before use. The service personnel should acquaint themselves
with the use of the test equipment. Electrical safety tests should meet the requirements of the new edition of standards EN and UL
These electrical safety tests do not supersede local requirements. All devices using the AC mains and connected to medical
equipment within patient environments must meet the requirements of the IEC medical electrical systems standard and should be
put under electrical safety tests at the frequency recommended for the patient monitor. Electrical safety tests are intended to check if
potential electrical hazards to the patient, operator or service personnel of the equipment. Electrical safety test should be performed
under normal ambient conditions of temperature, humidity and pressure. The electrical safety test plan described hereafter takes
601 safety analyzer as an example. Different safety analyzers may be used in different areas. Be sure to choose applicable test plan.
Connection of the equipment is shown below: 3-19
50 Tools required: Safety analyzer Isolation transformer Enclosure Leakage Current Test 1. Connect the 601 safety analyzer to an AC
power supply (264 V, 60 Hz). 2. Connect SUM terminal of the applied part connection apparatus to RA input terminal of 601 safety
analyzer, another terminal to the applied part of EUT. 3. Connect the EUT to the analyzer s auxiliary output connector using a power
cord. 4. Attach one end of the red lead to the Red input terminal of the analyzer, and the other end to tinsel over the enclosure of the
EUT. 5. Power on the 601 safety analyzer and then press the 5-Enclosure leakage button on the analyzer s panel to enter the
enclosure leakage test screen. 6. Under normal condition, the enclosure leakage current should be no greater than 100 µa. Under
single fault condition, it should be no greater than 300 µa Earth Leakage Current Test 1. Connect the 601 safety analyzer to an AC
power supply (264 V, 60 Hz). 2. Connect SUM terminal of the applied part connection apparatus to RA input terminal of 601 safety
analyzer, another terminal to the applied part of EUT. 3. Connect the EUT to the analyzer s auxiliary output connector using a power
cord. 4. Power on the 601 safety analyzer and then press the 4-Earth leakage button on the analyzer s panel to enter the earth
leakage test screen. 5. Under normal condition, the earth leakage current should be no greater than 300 µa. Under single fault
condition, it should be no greater than 1000 µa. 3-20
51 3.7.3 Patient Leakage Current Test 1. Connect the 601 safety analyzer to an AC power supply (264 V, 60 Hz). 2. Connect SUM
terminal of the applied part connection apparatus to RA input terminal of 601 safety analyzer, another terminal to the applied part of
EUT. 3. Connect the EUT to the analyzer s auxiliary output connector using a power cord. 4. Power on the 601 safety analyzer and
then press the 6-Patient leakage button on the analyzer s panel to enter the Patient leakage test screen. 5. Repeatedly press the
Applied Part button to measure AC and DC leakage alternatively. DC leakage reading is following by DC. 6. Under normal status, the
patient leakage current should be no greater than 10 µa. Under single fault condition, it should be no greater than 50 µa Patient
Auxiliary Leakage Current Test 1. Connect the 601 safety analyzer to an AC source (264 V, 60 Hz). 2. Connect the equipment under test
(EUT) to the analyzer s auxiliary output connector using a power cord. 3. Connect the sensors of the applied part to the applied part
connection apparatus, whose RA-P terminal is connected to 601 safety analyzer s RA terminal (which is turned on) and SUM terminal
to 601 safety analyzer s LA terminal. RA terminal is switched to on. 4. Power on the 601 safety analyzer and then press the 8-Patient
Auxiliary Current Test button on the analyzer s panel to enter the patient auxiliary current test screen. 5. Repeatedly press the
Applied Part button to measure AC and DC leakage alternatively. DC leakage reading is following by DC. 6. Under normal status, the
patient auxiliary leakage current should be no greater than 10 µa. Under single fault condition, it should be no greater than 50 µa. 321
52 3.8 Touchscreen Calibration 1. Select the [Cal. Screen] QuickKey or select [Main Menu] [Maintenance >>] [User Maintenance >>]
enter the required password [Cal. Touchscreen]. 2. The symbol will appear at different positions of the screen. 3. Select, in turn, the
central point of the symbol. 4. After the calibration is completed, the message [Screen Calibration Completed!] is displayed. Select
[Ok] to confirm the completion of the calibration. 3.9 Recorder Check 1. Print ECG waveforms. The recorder should print correctly and
printout should be clear. 2. Set the recorder to some problems such as out of paper, paper jam, etc. the patient monitor should give
corresponding prompt messages. After the problem is removed, the recorder should be able to work correctly. 3. Switch automatic
alarm recording for each parameter ON and then set each parameter s limit outside set alarm limits. Corresponding alarm recordings
should be triggered when parameter alarms occur. 3-22
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