MODEL MD ET6 ETCO2
MODULE
USER GUIDE
1
ATTENTION
Any one who use, service, resale this module should read this guide
carefully. Any operation not according to this guide may cause severe
aftermath, such as damaging patient and module or getting wrong data. The
operator who make mistake should take the responsibility upon oneself.
Notice
The information contained in this document is subject to change without notice.
Meditech Equipment Co., Ltd makes no warranty or representation of any kind with
regard
to this material. Meditech Equipment Co., Ltd specifically disclaims all warranties,
including but not limited to the implied warranties of merchantability and fitness for a
particular purpose.
Meditech Equipment Co., Ltd shall not be liable for errors, omissions or misstatements
contained in this document. In no event shall Meditech Equipment Co., Ltd be liable for
any damages, including, but not limited to loss of data, lost profits or any other
incidental, special or consequential damages in connection with the furnishing,
performance, or use of this material.
Meditech Equipment Co., Ltd assumes no responsibility for the use or reliability of its
software on equipment that is not furnished by Meditech Equipment Co., Ltd Meditech
Equipment Co., Ltd reserves the right to change the protocol described in this document
without prior notice. Meditech Equipment Co., Ltd makes no warranty of any kind with
regard to software applications that are created by the user. This document contains
proprietary information that is protected by copyright. All rights are reserved. Any
unauthorized copying, storage, reproduction or translation of this document in any form
is strictly prohibited.
Meditech Equipment Co. Ltd.
Address: Nanjing Road No.100, Qingdao, Shandong Province, P. R. China
Office: Shandong Road No 22 , Qingdao, Shandong Province, P. R. China
China Tel: 86-532-85832673 81705331
Fax: 86-532-81705332
Copyright © 2009. All rights reserved. No part of this guide may be reproduced without
the written permission of Meditech Equipment Co., Ltd
2
Warranty
Equipment manufactured or distributed by Meditech Equipment Co., Ltd , is fully
guaranteed, covering materials and workmanship, for a period of one year from the date
of shipment, except for certain disposable products and products with stated guarantees
other than one year.
Meditech Equipment Co., Ltd reserves the right to perform guarantee service(s) at its
factory, at an authorized repair station, or at the customer's installation.
Meditech Equipment Co., Ltd obligations under this guarantee are limited to repairs, or at
Meditech option, replacement of any defective parts of our equipment, except
calibration gasses, without charge, if said defects occur during normal service. Claims
for damages during shipment must be filed promptly with the transportation company.
All correspondence concerning the equipment must specify both the model name and
number, and the serial number as it appears on the equipment.
Improper use, mishandling, tampering with, or operation of the equipment without
following specific operating instructions will void this guarantee and release
Meditech Equipment Co., Ltd from any further guarantee obligations.
Regulatory
Meditech Equipment Co., Ltd is not responsible for obtaining any government or
regulatory
approvals for the product described in this document when used in a Host system not
provided by Meditech Equipment Co., Ltd . The use of any document or test data, or the
names Meditech Equipment Co., Ltd prohibited for use in any submission or application
for government or regulatory approval without prior written consent from Meditech
Equipment Co., Ltd
3
Contents
Contents…………………………………………………………………………………...4
Overview...…………………………………………………………………………….......5
Indication for Use.........................................………….......................................................5
Medical use of the product..........................………............................................................5
Principles of Operation .......................................................................................................6
Safety ........……………………………………………………………………………......6
Warnings ...……………………………………………………………………………......6
Cautions ....……………………………………………………………………………......7
Notes .……………………………………………………………………………..............8
Module Specifications ........................................................................................................9
Using the Model MD ET6 CO2 Module
................................................................................11
Connecting the MD ET6 Sampling
Kit..................................................................................12
Directions for Use of SINGLE PATIENT USE Nasal Sidestream Kits......………….....13
Directions for Use of SINGLE PATIENT USE Sidestream On-Airway Adapter Kits ...........14
Check Sampling Line Message .........................................................................................15
Conditions that Can Cause a Change in Flow Rate:..........................................................15
Clearing the “Check Sampling Line” Message ...........….................................................15
Maintenance Schedule…………………………………………………………………..16
Sampling Flow Rate Accuracy Check.............…..............................................................16
Cleaning the Sidestream On-Airway Adapters and Sidestream Sampling Kits .…..........16
Cannula and On-Airway Adapter Kit Material ................................................................16
CO2 Accuracy Check ........................................................…...........................................17
Accessories……………………………………………………………………………....17
Device Classification ......................................................…..............................................17
Host Communication Specifications...............................…...............................................18
Host Communication Protocol ......................................…................................................18
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Section 1
Overview
The Model MD ET6 ETCO2 Module is CO2 specifically designed for sidestream
measurement of CO2 using sophisticated infrared absorption spectroscopy. Model MD
ET6 is a sidestream sampling system with a 50ml/minute low sampling rate that is used
to measure the CO2 of non-intubated and intubated patients. Because of its unique
design, response is fast and there is less chance of erroneous, artifact data. The analyzer
portion of the module cannot be contaminated with patient secretions, therefore
maintenance requirements and overall cost-of-ownership are minimized.
The exclusive Meditech of sidestream sampling and on-airway adapter kits are easy to
use and durable enough even for long-term ventilator patients. Yet, they are
inexpensive and disposable.
The exclusive Meditech of DO NOT afraid water damaging CO2 module can give
you more confidence to use the Model MD ET6 module.
AUTO zero function make you easily deal with too fast of temperature change and
protean CO2 concentration of environment.
The Model MD ET6 Module is easy for you to configure your patient monitoring
systems with state-of-the-art CO2 monitoring technology that is affordable and easy to
use.
Indications for Use
●The intended use of the Model MD ET6 ETCO2 Module is to provide carbon dioxide
monitoring to a host monitoring system during anesthesia / recovery, in the intensive care
unit (ICU), and in Emergency Medicine/Transport or Respiratory care.
Medical use of the product
●The Model MD ET6 ETCO2 Module is used to monitor continuous carbon dioxide
and report the End Tidal carbon dioxide (ETCO2), inspired CO2 and respiratory rate
values of the intubated and non-intubated adult, pediatric, infant and neonatal patient.
●The Model MD ET6 ETCO2 Module is indicated for use in care areas such as, but
not limited to critical care, intensive care, anesthesia, medical/surgical units, LTAC
units, emergency department, sleep labs and during intra-hospital transport and interhospital transport.
●For use in monitoring patients in requiring ventilator support, receiving procedural
sedation, during transport, during anesthesia or those in respiratory distress, respiratory
arrest or that have asthma, COPD or other disorders where the patient's ETCO2 and
capnogram will benefit the caregiver in the treatment of the patient.
●For use in monitoring patients pre- and post-intubation.
●To assist in the setup, management and weaning of the patient that is connected to a
“conventional” mechanical ventilator.
5
Principles of Operation
The Model MD ET6 ETCO2 Module is used for the continuous measurement of
CO2 (carbon dioxide) and respiratory rate.
Model MD ET6 is a sidestream sampling system with a 50 ml/minute low sampling rate that is
used to measure the CO2 of non-intubated and intubated neonate, infant, pediatric and adult patients
using specially designed sampling cannula and on-airway adapter kits. These kits incorporate a
drying line and the sampling cell that provides maximum filtration of fluids and
contaminants and protects the system from aspiration of these fluids.
In Model MD ET6, infrared light is generated by the module and beamed through the
sampling cell to a detector on the opposite side. CO2 from the patient that is aspirated
into the sampling cell absorbs some of this infrared energy. The monitor determines CO2
concentration in the breathing gases by measuring the amount of light absorbed by these
gases. ETCO2 is displayed as a numerical value in millimeters of mercury (mmHg). In
addition, a CO2 waveform (capnogram) may be displayed which is a valuable clinical
tool that can be used to assess patient airway integrity and proper endotracheal tube (ETT)
placement. Respiration rate is calculated by measuring the time interval between detected
breaths.
Safety
Warnings
WARNING
Indicates a potentially harmful condition that can lead to personalinjury.
●Explosion Hazard: DO NOT use in the presence of flammable anesthetics or other
flammable gasses. Use of the Model MD ET6 ETCO2 Module in such environment
may present an explosion hazard.
●Electrical Shock Hazard: Always disconnect the Model MD ET6 ETCO2 Module
before cleaning. Do NOT use if it appears to have been damaged. Refer servicing to
qualified service personnel.
●Device is to be used by licensed practitioner, or other qualified medical personnel
properly trained in its use.
●Follow precautions for electrostatic discharge (ESD) and electromagnetic interference
(EMI) to and from other equipment.
● Failure of Operation: If the Model MD ET6 ETCO2 Module fails to respond as described in
this user guide; DO NOT use it until approved for use by qualified personnel.
●DO NOT position the module cables or tubing in any manner that may cause
entanglement or strangulation. Support the Model MD ET6 airway adapter to
prevent stress on the ET tube.
●Reuse, disassembly, cleaning, disinfecting or sterilizing the single patient use cannula
6
kits and on-airway adapters may compromise functionality and system performance
leading to a user or patient hazard. Performance is not guaranteed if an item labeled as
single patient use it used.
●Inspect the sidestream on- airway adapters and sidestream sampling kits for damage prior to use.
DO NOT use the sidestream on- airway adapters and sidestream sampling kits if they appear to be
damaged or broken.
●Replace the sidestream on- airway adapters and sidestream sampling kits if excessive
secretions are observed.
●Monitor the CO2 waveform (Capnogram). If you see changes or abnormal appearance
check the patient and the sampling line. Replace line if needed.
●Do not operate the Model MD ET6 ETCO2 Module when it is wet or has
exterior ondensation.
●Do not apply excessive tension to any cable.
●Electrical Shock Hazard; No user serviceable parts inside
●DO NOT use device on patients that can not tolerate the withdrawal of 50 ml/min +/10ml/min from the airway or patients that can not tolerate the added dead space to the
airway.
●Do not connect the exhaust tube to the ventilator circuit.
●Before use, carefully read the Operator’s Guide and these operating instructions.
●Warnings to the OEM:
●The Host system shall provide any required electrical isolation.
●The Model MD ET6 CO2 Module is not patient isolated. Use of the module does
not require direct patient contact. If isolation is desired or required, it is the
responsibility of the Host system to provide the necessary isolation.
Cautions
CAUTION：
Indicates a condition that may lead to equipment damage or
malfunction.
●Electrical Shock Hazard; the Model MD ET6 CO2 Module is not user serviceable.
Refer servicing to qualified personnel.
●DO NOT respire around the ZERO hole, especially when the MD ET6 module power
on and run a offset calibration.
●Follow precautions for electrostatic discharge (ESD) and electromagnetic interference
(EMI) to and from other equipment.
●Caution: Federal (U.S.A.) law restricts the Model MD ET6 CO2 Module to
sale, distribution, or use by or on the order of a licensed medical practitioner.
●Use only Meditech approved accessories
●DO NOT use the Model MD ET6 CO2 Module if it fails to operate properly,
appears to have been damaged, is wet or has exterior condensation.
●DO NOT sterilize or immerse Model MD ET6 CO2 Module in liquids.
●DO NOT clean the Model MD ET6 CO2 Module and accessories except as directed in
this
7
guide.
●DO NOT apply excessive tension to the Model MD ET6 CO2 Module cable.
●DO NOT store the Model MD ET6 CO2 Module at temperatures less than -40º F (-40º
C)
or greater than 158º F (70º C).
●DO NOT operate the Model MD ET6 CO2 Module at temperatures less than 32º F (0º
C)
or greater than 110º F (50º C).
●Remove the sampling line from the module when not in use.
●DO NOT stick appendage into sampling receptacle.
●Always insert sampling cell before inserting the on-airway adapter into the ventilated
circuit
●Always remove the on-airway adapter from the ventilated circuit before removing the
sampling cell
●Cautions for the OEM
●The Host system shall monitor for Model MD ET6 CO2 Module connectivity
and report the status and messages as required
●In the presence of electromagnetic devices (i.e., electrocautery), patient
monitoring may be interrupted due to electromagnetic interference.
Electromagnetic fields up to 20 V/m will not adversely affect module
performance.
●Compatible accessories to be listed in this Manual, precautionary statement to use
only approved accessories.
Notes
NOTES
A point of particular interest or emphasis intended to provide more
effective or convenient.
●Recommended operating temperature is 32º F (0º C) to 110º F (50º C).
●The Model MD ET6 CO2 Module contains no user serviceable parts. Refer service
to qualified service personnel.
●This product and its accessories are latex free.
●After the life cycle of the Model MD ET6 CO2 Module and its accessories have been
met, disposal should be accomplished following national and/or local requirements.
●Nitrous oxide, elevated levels of oxygen, helium , Xenon, halogenated hydrocarbons
can lightly influence the CO2 measurement(less than 1% of reading).
●Barometric pressure has been measured and its effect to CO2 consistence has
been compensated by the Model MD ET6 CO2 Module itself.
8
Section 3
Module Specifications
The Model MD ET6 CO2 Module specifications are subject to change without notice.
Unless otherwise stated, all CO2 measurements are made following an airway adapter
zero, with
5% CO2 gas, balance N2 at 25 degrees C, and Pb = 760 mmHg with 2 liters per minute
flow. The stabilization time for full specification testing of the Model MD ET6 CO2
Module over the entire temperature range is 20 minutes.
Model MD ET6 CO2 Module - SPECIFICATIONS
Carbon Dioxide Monitoring:
Mode of Sampling
Sidestream
Principle of Operation
Non-dispersive infrared (NDIR) single beam optics, dual
wavelength, no moving parts
Initialization Time
Capnogram displayed in less than 4 seconds, At an ambient
temperature of 25° C, full specifications within 2 minutes
CO2 Measurement
0 to 152 mmHg, 0 to 20.0% 0 to 20 kPa (Barometric Pressure
Range
supplied by module and mmHg reading is auto-calculated )
CO2 Calculation Method BTPS (Body Temperature Pressure Saturated)
CO2 Response Time
CO2 Resolution
CO2 Accuracy *
<4 seconds - includes transport time and rise time
0.1 mmHg 0 to 69 mmHg 0.25 mmHg 70 to 152 mmHg
0 - 40 mmHg ± 2 mmHg
41 - 150 mmHg ± 8% of reading
Above 80 breath per minute ± 10% of reading
* NOTE: Gas temperature at 25° C.
CO2 Stability
Short /long Term Drift: Drift shall not exceed 1 mmHg
maximum. Module will auto run zero calibration when drift
exceed 1 mmHg.
RMS noise of the module shall be less than or equal to 0.25
mmHg at 5% CO2
100 Hz
2 to 150 breaths per minute (BPM)
± 1 breath
CO2 Noise
Sampling Rate
Respiration Rate Range
Respiration Rate
Accuracy
Calibration
ETCO2 Calculation
Method:
No routine user calibration required.
Peak of the expired CO2 waveform
9
Inspired CO2
Measurement
Range: 3 to 50 mmHg
Method: lowest reading of the CO2 waveform in the previous
breath
Compensations
need compensations for:
Expired O2, Balance gas (N2, N2O, He) and Anesthetic
Agents
Compensations for barometric pressure has been finished
by module itself.
Physical Characteristics and Host Interface:
Physical characteristics
Module weight is less than 186g Module Size: <76mm(wide)
*38mm(high)* 108mm(deep)
Cable length – 48.88 cm (unless otherwise specified)
Data Interface
RS-232, bi-directional, 19200 baud, standard N-8-1
Module Interconnection Standard- Lemo Redel 8-pin plastic, Material PSU
Module Plug: PAB.M0.8GL.AC39GZ
Bend Relief: GMA.1B.030.DA
Host Receptacle: PKB.M0.8GL.LA
Custom configurations available upon request.
Pinout:
1 VA 5.0V
2 SHIELD Shield return
3 DGND Digital return
4 VSRC 5.0V
5 TxD Serial data from MD ET6
6 RxD Serial data from Host
7 AGND Analog return
8 NC
Model MD ET6 CO2
The MD ET6 Module relies solely on the host system for
power.
module Voltage
The host system shall provide the following:
requirements
VA:+5.00 VDC 5.0%;
70 mA (350 mW)typ (Steady-state); 240 mA (1.2 W) max
(Offset calibration ). Ripple not to exceed 50.0 mV
VSRC: DC Output Voltage:+5 V
Output Current: 40 mA .
Power
interface
must conform to IEC 60601-1
Power Rating
Total System
Power:
Offset calibration:<1.1 W
Steady-state < 0.5 W
Model MD ET6 CO2 module - SPECIFICATION
Environmental:
Temperature and Humidity
Operating: 0 to 50°C, 10 to 90% RH, non-condensing
Storage: -40 to 60°C, 10 to 90% RH, non-condensing
Atmospheric Pressure
Storage: 400-800 mmHg
Protection against electric shock The module does not provide electrical isolation for
enclosure leakage current, patient risk circuit, or
patient auxiliary current. It is the responsibility of the
10
Mode of operation
Category AP/APG
Water Resistance
Shock Impact
Radiated emissions
Electrostatic discharge
immunity
Radiated immunity
Host System to ensure that the power supply conforms
to applicable standards - Recommend IEC 60601-1
Type BF.
Model MD ET6 CO2 module is rated for continuous
use.
No
is required.
AP marking
- This device
is not suitable for use in the presence
of a flammable anesthetic mixture with air or nitrous
oxide
IPX4 - Splash-proof - Module only (When gas dryer
line is inserted into the gas-in receptacle)
IEC TR 60721-4-7 Class 7M3 (designed to withstand
environments subject to significant vibrations or high
shock levels)
EN60068-2-27 Shock
EN60068-2-64 Random Vibration
Host system dependent, designed to meet the
requirements of EN55011
- CISPR 11 Class B 30 MHz to 1000 MHz
Host system dependent, designed to meet the
requirements of IEC 61000-4-2 (2001-04) 6 kV
conducted 8 kV air discharge
Host system dependent, designed to meet the
requirements of IEC 61000-4-3 (2002-03)
80 MHz to 2.5 GHz, 20 V/m
Host system dependent, designed to meet the
requirements of IEC 61000-4-6 (2001-04)
Immunity to conducted
disturbances induced by RF
fields
Mechanical:
Mechanical strength
Cable Strain Relief, resistance to pull-out: Cable strain (bend)
relief system for the module enclosure shall withstand a pull of
30 pounds without failure to either the cable or the enclosure.
Cable Strain Relief, flexibility: The connector strain relief
system shall withstand 10,000 bend cycles.
Connector Retention Force: The average retention force of the
standard connector when pulling on the cable shall be 90
Newtons (20 pounds).
Regulatory
Regulatory Designed to meet the following:
IEC 60601-1
IEC 60601-1-2
EN55011
CISPR 11 Class B (Radiated and Conductive Emissions)
IEC 61000-4-2 Electrostatic Discharge Immunity
IEC 61000-4-3 Radiated Immunity
Designed to comply with the following:
93/42/EEC (MDD CE Marking)
11
FDA standards
ASTM F1456-01 Minimum Performance and Safety
Requirements for Capnometers
ISO/FDIS 21647:2004 (E)
Section 4
Using the MD ET6 Module
This section provides information regarding the Model MD ET6 CO2 module and its use
with the CO2 cannula kits and the on-airway adapter kits. The Model MD ET6 CO2
module is a rugged, solid-state, sidestream module. It is factory calibrated and does not
require further calibration.
CAUTION: Do not use on patients that cannot tolerate the removal of 50ml/min from
their total minute ventilation.
Module Exhaust
The exhaust port is on the side of the module (Gas out).
Connecting the lines
Figure 1
1. The gas drier line must be inserted into the sampling cell receptacle of the Model
MD ET6 CO2 module as shown in Figure 1. There is a Luer connector (male) at the
gas drier line and a Luer connector (female) at the module.
2. Connect the Sampling line
to the gas drier line and connect the T-fitting to the samling line
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Figure 2
There is a Luer connector (male) at the gas drier line and a Luer connector (female) at
the nasal Sampling line.
3. If the module is used with an anaesthesia machine, connect the gas sampling line to the
On-Airway Adapter (T-fitting connector) and the gas dryer line.
Figure 3
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Zeroing the Model MD ET6 CO2 module
The Model MD ET6 CO2 module is compatible only with Meditech’s sidestream CO2
accessories. The Model MD ET6 CO2 module can automatically inspect if the ZERO
being correct or not and run an offset calibration program if the ZERO is error. When
module runs the offset calibration program, there is no waveform being displayed (about
6 seconds), when the program running down, CO2 waveform will display again. Also the
operator can run an offset calibration if he feels the zero is error, but we DO NOT suggest
an operator to do so. An “Offset calibration” is a quick process that allows the Host
system to adjust to the special characteristics of a particular Model MD ET6 CO2 module;
it is necessary only when requested. Such a request will occur if a change is detected in
the Model MD ET6 CO2 module.
• System does not allow offset calibration for 20 seconds after the last breath is detected.
• System does not allow offset calibration if temperature is not stable
• Offset calibration program maybe get a wrong ZERO if the ZERO hole is occluded.
NOTE
DO NOT jam the ZERO hole at any time. For best results, wait 5 minutes to allow the
Model MD ET6 CO2 module to warm up before performing the offset calibration
procedure.
Directions for Use of SINGLE PATIENT USE Nasal Sidestream Kit
This kit is intended for monitoring the CO2 of non-intubated patients. Select the
sidestream cannula kit that is appropriate for the patient size and application.
CAUTION:
The Nasal Cannula kit are intended for single patient use. Do NOT reuse or sterilize the
cannula kit as system performance will be compromised.
1. Verify that the cannula kit is clean, dry and undamaged. Replace the cannula kit if
necessary.
2. Insert the gas drier line into the Gas In connector as shown in Figure 1 on previous
page. Connect the gas drier line and the gas sampling line as shown in Figure 2. Connect
the gas sampling line and the Nasal Cannula as shown in Figure 3.
3. Place the nasal cannula kits onto the patient as shown in Figure 5.
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Directions for Use of SINGLE PATIENT USE Sidestream
Adult/Pediatric/Infant On-Airway Adapter Kits
The Adult/Pediatric/Infant sidestream on-airway adapter kits should be used when
monitoring intubated patients.
CAUTION: The Adult/Pediatric/Infant on-airway adapters are intended for single patient
use. Do NOT reuse or sterilize the adapter kit as system performance will be
compromised.
1. Verify that the on-airway adapter is clean, dry and undamaged. Replace the on-airway
adapter kit if necessary.
2. Insert the gas drier line into the Gas In connector as shown in Figure 1 on previous
page. Connect the gas drier line and the gas sampling line as shown in Figure 2. Connect
the gas sampling line and the on-airway adapter as shown in Figure 6.
Figure 6
3. The sampling line kits are intended for use when using the MD ET6 CO2 system
with ventilator and anesthesia circuits that have an integrated airway adapter with a
female Luer. Connect male luer connector to the female port on the airway adapter.
4. Check that connections have been made correctly by verifying the presence of a proper
capnogram on the Patient Monitor.
CAUTION: Always insert the gas drier line of the MD ET6 sampling kit into the
Sampling connector on the MD ET6 Module before inserting the on-airway adapter into the
ventilator circuit. Failure to follow this, may introduce a leak in the circuit, thereby
reducing set minute volume.
NOTE: Do not place the on-airway adapter between the ET tube and the elbow as this
may allow patient secretions to accumulate in the adapter. If pooling does occur, the
on-airway adapter may be removed from the circuit, rinsed with water (or sterile water)
and reinserted into the circuit. If rinsed, make sure that no water has entered the sampling
tubing. If so, blow out water or replace the kit. To prevent moisture from draining into
the on-airway adapter kit tubing, always place the on-airway adapter tubing in an up
position (see Figure 6).
Do not connect any non-approved extension tubing or nasal cannula to this sampling line
kit as device performance will be affected.
15
15
Check Sampling Line Message
The sampling flow rate of the MD ET6 MD ET6 is continually monitored. If the flow rate
falls outside the nominal operating range and continues for 15 seconds, the message
“Check Sampling Line” will be sent to the host monitor. The pump will shut off after 2
minutes if the condition that caused this change is not corrected. You should send RESET
to module
and then the module will run again.
Conditions that Can Cause a Change in Flow Rate:
Water, mucous or other patient contaminate has entered the sampling tubing.
The sampling tubing is crimped or pinched so that the sampling flow rate has
decreased.
The exhaust port of the module is obstructed.
The sampling line is damaged.
The sampling line has been cut, or split, causing the flow rate to increase.
Clearing the “Check Sampling Line” Message
When the “Check Sampling Line” message is displayed, the user should inspect the
sampling line kit to verify that none of the conditions described above are present.
Replace with a new sampling kit if needed.
If the user removes the sampling cell for inspection and then reinserts the sampling
cell without correcting the condition, the “Check Sampling Line” message will reappear.
The user should verify that the exhaust port is not obstructed or blocked.
The “Check Sampling Line” message will clear and the sampling pump will not be
turned off if the condition that caused the flow rate change is corrected within 2 minutes.
The “Check Sampling Line” message will clear if the sampling cell is removed or if
the system is reset.
Section 5
Maintenance Schedule
The Model MD ET6 CO2 module flow rate accuracy should be verified by
direct measurement using a calibrated flow meter every 12 months.
Sampling Flow Rate Accuracy Check
The test must be performed under load. Use the MD ET6 Adult On-Airway Adapter
Kit for proper test verification.
1. Connect the Model MD ET6 CO2 module connector to the power supply or host
monitor.
2. Connect the RS232 output of the power supply to the host system.
3. Attach the MD ET6 Adult On-Airway Adapter Kit to the gas in connector of the Model
MD ET6 CO2 module.
4. Using the module status provided in the MD ET6 MD ET6 Serial protocol, wait for the
Model MD ET6 CO2 module to warm up to its operating temperature. (Look for the
temperature status to be set to “Stable Operating Temperature” in the Serial protocol).
5. After the module warms up, and the messages have cleared, connect the calibrated
NOTE:
16
16
flow meter to the exhaust port of the module.
6. Verify that the flow rate is 50 ml/min ± 10 ml. If the measured flow rate is outside of
the specified limits, remove the MD ET6 CO2 Module from use and contact Meditech
Equipment Co., Ltd
Cleaning
Cleaning the Model MD ET6 CO2 module case, Cable and connector:
1. Use a cloth dampened with isopropyl alcohol 70%, a 10% aqueous solution of sodium
hypochlorite (bleach), a 2% gluteraldehyde solution, ammonia, mild soap or disinfectant
spray cleaner such as Steris Coverage® Spray HB.
2. Wipe down with a clean water-dampened cloth to rinse and dry before use. Make
certain that the gas in connector are clean and dry before reuse.
NOTE
Do not immerse or sterilize the MD ET6 Module
Cleaning the Sidestream On-Airway Adapters and
Sidestream Sampling Kits
MD ET6 Sidestream on-airway adapters and sidestream sampling kits are single patient use.
Treat in accordance with hospital protocols for handling single patient use devices.
Cannula and On-Airway Adapter Kit Material
Component
Material
Tubing
Nasal Cannula
Sampling line
On-Airway Adapter
Gas drier line
Polyvinyl chloride, Medical Grade
Plastisol
Cyro Cyrolite G20 and Polycarbonate
Rubberized acrylic Cyro Cyrolite G20, option –polycarbonate
Nafion
CO2 Accuracy Check
The following procedure should be performed to check the CO2 accuracy of the Model
MD ET6 CO2 module. It is recommended that this procedure be performed every 12
months.
1. Connect the Model MD ET6 CO2 module to the Host monitor. Connect all airway
cannula to the Model MD ET6 CO2 module. Make sure the Model MD ET6 CO2 module
is disconnected from the patient circuit.
2. Turn on the Host monitor.
3. On the Host monitor, change to the CO2 Accuracy Mode. This mode can be either a
separate accuracy check/diagnostic screen or a CO2 averaging mode. This mode will
need to display the CO2 waveform value as a numeric instantaneous value.
4. Using the module status provided in the MD ET6 MD ET6 Serial protocol, wait for the
Model MD ET6 CO2 module to warm up to its operating temperature. (Look for the
temperature status to be set to “Stable Operating Temperature” in the Serial protocol).
5. Set the CO2 Units setting of the Model MD ET6 CO2 module to percent.
6. Zero the Model MD ET6 CO2 module on the airway adapter being used in this test.
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7. Attach a regulated flowing gas mixture of 5% CO2, balance N2 to the airway adapter.
Set the flow rate of the gas to 2 liters per minute.
8. Allow 10 seconds for the gas mixture to stabilize and observe the CO2 value. The
expected value is 5% ± 0.20%.
9. If a waveform is present, verify that it appears as a straight line at approximately 5
percent.
10. The accuracy check is now complete. Remember to set the Model MD ET6 CO2
module settings for units back to their previous settings.
11. This accuracy check can be completed in just a few minutes.
Section 6
Accessories
NM Part Number
Single Patient Use
Nasal CO2 Sampling Cannula Intended for use when monitoring
non-intubated patients.
Gas drier line
Gas sampling line
On-Airway connector
Section 7
Device Classification
Device Classification
IEC/EN 60601-1:
IEC 60601-1 § 5.1 Type of protection
against electrical shock
IEC 60601-1 § 5.2 Type of protection
against electrical shock
IEC 60601-1 § 5.3 Type of protection
against harmful ingress of water
IEC 60601-1 § 5.4 Methods of sterilization
IEC 60601-1 § 5.5 Degree of safety of
application in the presence of a flammable
anesthetic mixture with air, oxygen, or
nitrous oxide.
IEC 60601-1 § 5.6 Mode of operation
Class I and II externally powered
equipment
Recommended: Type BF equipment
IPX 4 – Splash proof Equipment with
sampling cell installed.
(See Maintenance on page 17.)
Type AP equipment: Equipment not
suitable for use in the presence of a
flammable anesthetic mixture with air or
nitrous oxide.
Continuous operation
Section 8
Host Communication
Specifications
Host Communication Specifications
Serial Communications protocol
The Model MD ET6 CO2 module shall use a
proprietary protocol as the
standard
data
communication protocol to the Host system. The signal
levels shall conform to the RS-232 standard and be a in
a
bi-directional
binary
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Serial communication rate
Data Output
format.
Nominal data rate between the module and the Host
system will be 19200 Baud, standard N-8-1
Real time CO2 waveform, barometric pressure,
End-Tidal CO2, Inspired CO2, Respiratory Rate.
The Model MD ET6 CO2 module provides the Host
System with status information through the
communications protocol.
Host Communication Protocol
It is the responsibility of the host system to monitor connectivity to the MD ET6 Module
and
provide status information and messages to the user. The module will provide status
information to the host via the communication protocol. It is the host’s responsibility to
provide any visual or audible indications of alert conditions to the end user.
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