Mainstream CMZ60MEMO User manual

Report reference No: KPN-CE-015 Rev: V3.0
Mainstream
EtCO2 SENSOR
CMZ60MEMO
USER’S GUIDE
ENGLISH

Report reference No: KPN-CE-015 Rev: V3.0
Contents
1. Intended use ................................................................................................................................................................ 5
2. Safety............................................................................................................................................................................ 5
2.1 Warnings............................................................................................................................................................ 5
2.2 Cautions............................................................................................................................................................. 7
2.3 Notes .................................................................................................................................................................. 7
2.4 Symbols and Labels......................................................................................................................................... 8
3.1 Overview ............................................................................................................................................................ 9
3.2 Principle of operation...................................................................................................................................... 10
4. Preparations for use.................................................................................................................................................. 10
4.1 Setting up......................................................................................................................................................... 10
4.2 Starting up........................................................................................................................................................ 11
4.3 Shut down........................................................................................................................................................ 12
4.4 Connecting to the MEMO .............................................................................................................................. 12
4.5Adapter Selection.......................................................................................................................................... 12
4.6 Precautions...................................................................................................................................................... 13
5.1 Buttons ............................................................................................................................................................. 13
5.2 Monitoring ........................................................................................................................................................ 13
5.2.1 EtCO2............................................................................................................................................................ 13
5.2.2 Respiratory Rate.......................................................................................................................................... 13
5.2.3 Capnogram................................................................................................................................................... 14
5.2.4 CO2 settings................................................................................................................................................. 14
5.3 Indicators and alarms..................................................................................................................................... 14
5.3.1 Alarm signals................................................................................................................................................ 15
5.3.2 Default limits for alarms.............................................................................................................................. 16
5.3.3 Alarm silence................................................................................................................................................ 16
5.3.4 Battery status indicator............................................................................................................................... 17
5.3.5 Adjusting the alarm limit.............................................................................................................................. 17
6. MEMO and Accessories........................................................................................................................................... 18
7. Maintenance............................................................................................................................................................... 18
7.1 Battery replacement ....................................................................................................................................... 18
7.2 Cleaning........................................................................................................................................................... 19
7.3 Airway adapter .......................................................................................................................................... 19
7.4 Zeroing procedure .......................................................................................................................................... 19
7.5 Gas span check .............................................................................................................................................. 20
7.6 Troubleshooting............................................................................................................................................... 21
8. Specifications............................................................................................................................................................. 21
8.1 General specifications.................................................................................................................................... 21
8.2 Interfering gas and vapor effects.................................................................................................................. 22
8.3 Environmental ................................................................................................................................................. 23
8.4 Classifications ................................................................................................................................................. 23
8.5 Compliance................................................................................................................................................... 23
9 EMC statement........................................................................................................................................................... 24
9.1 Description....................................................................................................................................................... 24
9.2 precautions in use........................................................................................................................................... 24
9.3 Matching accessories..................................................................................................................................... 24
9.4 precautions regarding .................................................................................................................................... 25

Report reference No: KPN-CE-015 Rev: V3.0

Report reference No: KPN-CE-015 Rev: V3.0
0123
Declaration of Conformity
Complies with 93/42/EEC Medical Device Directive when connected to medical devices
approved by Qinhuangdao Kapunuomaite Medical Equipment S&T Co.,Ltd.
Disclaimer
Qinhuangdao Kapunuomaite Medical Equipment S&T Co.,Ltd. shall in no event be liable for
any direct, indirect, special or consequential damages including without limitation damages
for loss of business profits, loss of income, business interruption，loss of business
information, loss of use or other related exposures, however caused, arising from the faulty
or incorrect use of the product.
Liability
Qinhuangdao Kapunuomaite Medical Equipment S&T Co.,Ltd. guarantees that the product
delivered has been thoroughly tested to ensure that it meets its published specifications.
Warranty
Please contact us for details regarding warranty and product returns.
Use of the product for other than its intended use, or if it has been repaired by anyone
except us or a our authorized service center, or altered or modified or used without
following the instructions provided with the product, voids the warranty.
Trademarks
Qinhuangdao Kapunuomaite Medical Equipment S&T Co.,Ltd. owns the licensed
trademark: Capnomed.
Copyright
This document contains proprietary information that is protected by copyright. All rights are
reserved. No part of this document may be photocopied, reproduced or translated to
another language without prior written consent of Qinhuangdao Kapunuomaite Medical
Equipment S&T Co.,Ltd.
Authorized EU Representative
Company name: Shanghai International Holding Corp. GmbH(Europe)
Address: Eiffestrasse 80,20537 Hamburg, Germany
Contact: Jin Liang
Competent Authority:
Behörde fr Gesundheit und Verbraucherschutz, Referat V42
Web site: www.capno-med.com
The information in this document is subject to change without notice.

Report reference No: KPN-CE-015 Rev: V3.0
1. Intended use
CMZ60MEMO is a reference for professionals in respiratory care. It is mainly used in the
following areas:
a) Monitoring the parameters of the patient's exhaled carbon dioxide;
b) Monitoring of carbon dioxide exhalation during sedation, dyspnea, Apnea，respiratory
arrest, asthma and chronic obstructive pulmonary disease in patients requiring ventilator
support;
c) Monitor carbon dioxide exhalation before and after patient intubation.
This product is not intended to be used as the only method for monitoring patients. It should
always be used with other vital signs monitoring equipment and at the same time (or in
combination with professional judgment) to determine the condition of the patient.
The ETCO2 sensor is used in combination with a monitor and a ventilator to monitor the
patient's real-time CO2 waveform, ETCO2 value, FiCO2 value and breathing frequency.
ETCO2 sensors are designed to be used only by trained and authorized medical
professionals.
2. Safety
2.1 Warnings
Indicates a potentially harmful condition that can lead to personal injury.
WARNING! MEMO should only be used for the purpose and in the manner described in
this manual.
WARNING! MEMO is intended for use by authorized health care professionals only.
WARNING! MEMO must not be used with flammable anesthetic agents. Use of the
MEMO in such environment may present an explosion hazard.
WARNING! Use only the airway adapter manufactured by manufacturer.
WARNING! No modification of the MEMO probe or the MEMO airway adapters is allowed.
WARNING! MEMO airway adapters shall not be reused. Reuse of single use adapters can
cause cross infection. Used airway adapters shall be disposed of in accordance with local
regulations for medical waste.
WARNING! Do not use the MEMO adult/pediatric airway adapter with infants as the
adapter adds 6 ml dead space to the patient circuit.
WARNING! Do not use the MEMO infant airway adapter with adults as this may cause
excessive flow resistance.
WARNING! Measurements can be affected by mobile phones and RF communications
equipment. It should be assured that MEMO is used in the specified electromagnetic
environment.

Report reference No: KPN-CE-015 Rev: V3.0
WARNING! MEMO is intended only as an adjunct in patient assessment. It shall be used
in conjunction with the assessment of clinical signs and symptoms.
WARNING! If MEMO is used with a respirator or with harmful gases such as N2O, always
perform a pre-use tightness check of the patient circuit.
WARNING! Light transmission can be affected by secretions and moisture pooling on the
MEMO airway adapter windows. When using heated humidifiers special care should be
paid to position the airway adapter in a vertical position and to change airway adapter if
necessary.
WARNING! Do not use MEMO with nebulized medications as this may affect the light
transmission of the MEMO airway adapter windows.
WARNING! Do not operate the MEMO when it is wet or has exterior condensation.
WARNING! Audible alarm of any monitor may not be heard in some loud environments,
such as when sirens are in use and the care provider is more distant from the alarm
source. Alarm volume should be tested with the extremes of your noise environment to
confirm ability or limitations to hear an alarm in all circumstances of the environment.
WARNING! Replace batteries immediately when the Battery Status Indicator starts
blinking. Remaining battery time depends on battery type and other circumstances and
cannot be reliably predicted.
WARNING! Lithium batteries may present a fire or chemical burn hazard if mistreated. Do
not disassemble, heat above 100°C or incinerate. Dispose of used cell promptly. Keep
away from children.
WARNING! Use only alkaline batteries or energizer ultimate lithium L92 batteries. Use of
other Lithium batteries may present a risk of fire or explosion.
WARNING! DO NOT use it for patients who cannot tolerate an increased airway dead
space or who cannot tolerate a 50 ml/min ±10 ml airflow from the airway.
Warning!Don’t near active HF SURGICAL EQUIPMENT and the RF shielded room of an
ME SYSTEM for magnetic resonance imaging, where the intensity of EM
DISTURBANCES is high.
Warning!Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary, this
equipment and the other equipment should be observed to verify that they are operating
normally.
Warning!Use of accessories, transducers and cables other than those specified or
provided by the manufacturer of this equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this equipment and result in improper
operation.”

Report reference No: KPN-CE-015 Rev: V3.0
Warning!Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to any
part of the model CMZ60MEMO, including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment could result.
2.2 Cautions
Indicates a condition that may lead to equipment damage or malfunction.
CAUTION! Use only approved accessories.
CAUTION! If MEMO is used in a manner other than that for which it was intended,
unpredictable behavior could result.
CAUTION! The MEMO airway adapters are non-sterile devices. Do not autoclave the
devices as this will damage them.
CAUTION! Never sterilize or immerse MEMO in liquid.
CAUTION! Do not operate MEMO at ambient temperatures less than 0°C or greater than
40°C.
CAUTION! Do not store the MEMO at temperatures less than -20°C or greater than 70°C .
CAUTION! Do not clean the MEMO and accessories except as directed in this guide.
CAUTION! Federal law restricts this device to sale by or on the order of a physician.
CAUTION! Remove batteries if MEMO is not likely to be used for a period of time longer
than 90 days.
CAUTION! The signal port on MEMO host is only used as maintenance and upgrade by
manufacturer's authorized maintenance personnel. Non- manufacturer authorized
maintenance personnel must not use this signal port.
CAUTION! Maintenance personnel should use the IEC60950-1 Standard compliant
computer with a Windows 7 operating system and a USB 2.0 port for maintenance and
upgrades of MEMO. Maintenance personnel should use a dedicated data cable to connect
the MEMO host and computer for repair and upgrade operations.
2.3 Notes
A point of particular interest or emphasis intended to provide more effective or
convenient.
NOTE! Throughout this User’s Manual: MEMO airway adapter refers to both airway
adapter adult/pediatric and airway adapter Infant if not otherwise mentioned.
NOTE! A trained medical professional must determine the proper MEMO airway
adapter model for each patient application. No hardware or software configuration
6

Report reference No: KPN-CE-015 Rev: V3.0
changes result from the MEMO airway adapter model selected.
NOTE! The MEMO contains no user serviceable parts. Refer service to qualified service
personnel.
NOTE! This product and its accessories are latex free.
NOTE! After the life cycle of the MEMO and its accessories have been met, disposal
should be accomplished following national and/or local requirements.
NOTE! The alarm limits will be reset to default values after power off.
NOTE! Always carry spare batteries in the MEMO pouch.
NOTE! The presence of ambient air (0% CO2) in the MEMO airway adapter is of crucial
importance for a successful zeroing. Special care should be taken to avoid breathing
near the MEMO airway adapter before or during the zeroing procedure.
Note!The EMISSIONS characteristics of this equipment make it suitable for use in
industrial areas and hospitals (CISPR 11 class A). If it is used in a residential
environment (for which CISPR 11 class B is normally required) this equipment might not
offer adequate protection to radio-frequency communication services. The user might
need to take mitigation measures, such as relocating or re-orienting the equipment.
2.4 Symbols and Labels
Symbol
Title
Date of manufacture
Use-by date.
Manufacturer.
Serial number
Batch code
Catalog number
Authorized representative in the European Community.
Follow instruction for use
Caution (U.S.): Federal law restricts this device to sale
by or on the order of a licensed healthcare practitioner.
Do not re-use.
For EU only:Waste Electrical and Electronic Equipment
(WEEE)
Non sterilization.
Symbol for temperature
limitation/temperature range.

Report reference No: KPN-CE-015 Rev: V3.0
Symbol for humidity
limitation/humidity range.
Symbol for atmospheric pressure
limitation/ atmospheric pressure range.
CE certification mark.
For the complete list of symbols see technical specification.
Label
Title
Packing box main
label.
Packing box sub
label.
3. Device description
3.1 Overview
The MEMO is a mainstream carbon dioxide sensor comprised of a sensor body that fits on
top of a disposable airway adapter.

Report reference No: KPN-CE-015 Rev: V3.0
3.2 Principle of operation
The MEMO measures the concentration of CO2in the breathing gas based on the NDIR
technology. Different gases absorb infrared light of a specific wavelength.
The stationary infrared light source emits a beam of invisible infrared light through the
airway adapter, and the respiratory airflow flows in the airway adapter. As the beam passes
through the airway adapter, some light is absorbed by the gas mixture. The absorbed beam
reaches the infrared detector fixed at the other end. The infrared detector is equipped with
two filters of different wavelengths, one of which has very strong absorption of carbon
dioxide, and the other wavelength of carbon dioxide has no absorption.
The infrared detector converts the beam into an electrical signal, which is converted to a
digital value and sent to the microprocessor. The microprocessor then calculates the
carbon dioxide concentration in the breathing gas mixture using the ratio of the light of the
two measurement channels.
4. Preparations for use
4.1 Setting up
Unpack and inspect the MEMO for external damage. Please contact your local distributor in
case of damage.
1. Push the battery cover release button to the position，then push down the battery
cover and remove the battery cover.
2. Open the battery compartment and insert two (2) AAAbatteries. Make sure the batteries
are fitted according to the indicated polarity.
Figure 2
Releasing the battery cover
Figure 1 MEMO Index
Figure 3
Installing the batteries
9