Mainstream CMZ60MEMO User Manual

Mainstream CMZ60MEMO User Manual

Etco2 sensor

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

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Summary of Contents for Mainstream CMZ60MEMO

  • Page 1 Report reference No: KPN-CE-015 Rev: V3.0 Mainstream EtCO2 SENSOR CMZ60MEMO USER’S GUIDE ENGLISH...
  • Page 2: Table Of Contents

    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.
  • Page 3 Report reference No: KPN-CE-015 Rev: V3.0...
  • Page 4 Report reference No: KPN-CE-015 Rev: V3.0 Declaration of Conformity 0123 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 ,...
  • Page 5: Intended Use

    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;...
  • Page 6 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.
  • Page 7: Cautions

    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.
  • Page 8: Symbols And Labels

    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.
  • Page 9: Overview

    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.
  • Page 10: Principle Of Operation

    Report reference No: KPN-CE-015 Rev: V3.0 Figure 1 MEMO Index 3.2 Principle of operation The MEMO measures the concentration of CO in 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.
  • Page 11: Starting Up

    Report reference No: KPN-CE-015 Rev: V3.0 3. After battery installation, put the battery cover back into place, and then push the battery cover release button to the position. Figure 4 Installing the battery cover 4.2 Starting up 1. Press the airway adapter into the MEMO. It will click into place when properly seated. Figure 5 Connect with airway adapte 2.
  • Page 12: Shut Down

    After 60 seconds if the airway adapter is removed. ● 4.4 Connecting to the MEMO CMZ60MEMO is connected to other vital signs monitoring equipment by the respiratory line and respiratory mask. See figure as following: The cord of the sensor should be facing away from the patient.
  • Page 13: Precautions

    Report reference No: KPN-CE-015 Rev: V3.0 4.6 Precautions ⚫ any degradation in MEASUREMENT ACCURACY of the end‐tidal GAS READING as a function of respiratory rate and I:E ratio (inspiratory/expiratory time ratio) over their RATED ranges; ⚫ known adverse effects on stated performance due to the following: —...
  • Page 14: Capnogram

    4mm/s / 2mm/s / 1mm/s 2mm/s 5.3 Indicators and alarms The CMZ60MEMO is equipped with an alarm status indicator. The operator should look squarely at the CO2 monitor display. Operate and observe from a distance of 0.3m to 2m. The audible alarm sound may be checked by detaching the CapnoEasy Airway Adapter to...
  • Page 15: Alarm Signals

    Report reference No: KPN-CE-015 Rev: V3.0 5.3.1 Alarm signals When an alarm is triggered, an alarm status indicator in the lower right corner of the display is lit with a steady or blinking yellow light depending on alarm priority, together with an audible alarm beep according to the following table(the beep sound is only used to alert the operator Observe the information on the display screen in time, and it is not used to judge the alarm level only by beeps):...
  • Page 16: Default Limits For Alarms

    Report reference No: KPN-CE-015 Rev: V3.0 Clogged Adapter Battery Low Depend on other alarm signal Zero point Depend on other alarm signal adjustment 5.3.2 Default limits for alarms The default factory settings for the Apnea and the Low/High EtCO2 and RR alarms are as follows: Lower Limit Upper Limit...
  • Page 17: Battery Status Indicator

    Report reference No: KPN-CE-015 Rev: V3.0 5.3.4 Battery status indicator There is a battery status indicator in the upper right corner of the screen. The display status of the indicator changes according to the battery power: ⚫ When the battery is normal, the battery status indicator lights up with a steady green light.
  • Page 18: Memo And Accessories

    Below is a list of device models, versions and approved accessories. For an up to date list of accessories visit: Catalog Number(REF.NO.) Product Description CMZ60MEMO Mainstream EtCO2 Sensor MEMO Needed in order for MEMO to provide CSM01A Airway Adapter readings 7.
  • Page 19: Cleaning

    Report reference No: KPN-CE-015 Rev: V3.0 Use only alkaline batteries or energizer ultimate lithium L92 batteries. Use of other lithium batteries may present a risk of fire or explosion. NOTE: Always carry spare batteries with MEMO. 7.2 Cleaning 1. Remove the batteries before cleaning. 2.
  • Page 20: Gas Span Check

    Report reference No: KPN-CE-015 Rev: V3.0 MEMO will automatically return to normal measurement mode after zero completion. 7.5 Gas span check The MEMO does not require any routine calibration. A gas span check is recommended at regular intervals to make sure the measurement is within accuracy levels. The suggested interval for gas span check is once every year.
  • Page 21: Troubleshooting

    8. Specifications 8.1 General specifications Compact, battery powered, quantitative MEMO for mainstream Description CO2 monitoring of adult, pediatric and infant patients. Measurements CO2 partial pressure and respiratory rate 2 channel NDIR type gas analyzer,No moving parts...
  • Page 22: Interfering Gas And Vapor Effects

    Report reference No: KPN-CE-015 Rev: V3.0 CO2 Noise Noise RMS less than 1mmHg at 5% CO2 Total system response time 1.9s Recovery time after Unaffected defibrillator test Respiratory Rate 3-150 bpm Respiratory Rate Accuracy ± 1 bpm breath detect method adaptive threshold Sampling Rate 100 Hz.
  • Page 23: Environmental

    Report reference No: KPN-CE-015 Rev: V3.0 8.3 Environmental operating: 0 to 40 ° C. Temperature Storage and Transport: -20 to 70 ° C. operating: ≤90% RH, non-condensing. Humidity Storage and Transport: ≤90% RH, non-condensing. operating: 55kPa-105kPa. Atmospheric Pressure Storage and Transport: 55kPa-105kPa. Display 128 *128 pixels 1.44 inch TFT color display Dimensions...
  • Page 24: Emc Statement

    9 EMC statement 9.1 Description CMZ60MEMO only suitable for professional healthcare environment . 9.2 precautions in use Using accessories, transducers and cables other than those specified may result in increased electromagnetic emission or decreased electromagnetic immunity of the patient monitoring equipment.
  • Page 25: Precautions Regarding

    IEC 61000-3-3 Guidance and manufacturer’s declaration – electromagnetic immunity The CMZ60MEMO is intended for use in the electromagnetic environment specified below. The customer or the user of the EtCO2 Sensor should assure that it is used in such an environment...
  • Page 26 Rev: V3.0 Guidance and manufacturer’s declaration - electromagnetic Immunity The CMZ60MEMO is intended for use in the electromagnetic environment specified below. The customer or the user of the EtCO2 Sensor should assure that it is used in such an environment...
  • Page 27 Report reference No: KPN-CE-015 Rev: V3.0 2450, LTE Band 5240 WLAN Pulse 100 – 802.11 modulation 5240 5 800 b) 217 Hz 5785 NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.

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