Mainstream CMZ60MEMO, User Manual

Page 1: ...Report reference No KPN CE 015 Rev V3 0 Mainstream EtCO2 SENSOR CMZ60MEMO USER S GUIDE ENGLISH ...

Page 2: ...2 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 Gener...

Page 3: ...Report reference No KPN CE 015 Rev V3 0 ...

Page 4: ...t 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 Capnome...

Page 5: ...ed 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 prese...

Page 6: ...ries 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 ene...

Page 7: ...d 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 pe...

Page 8: ...pter 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 meas...

Page 9: ...ion 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 ...

Page 10: ...n 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...

Page 11: ...he audible alarm sound may be checked by detaching the MEMO airway adapter to generate a No Adapter alarm If the EtCO2 value is non zero ensure that there has not been an accumulation of CO2 between the sensor body and the MEMO airway adapter by removing and reattaching the MEMO airway adapter If the EtCO2 value still displays a non zero value after this procedure perform a zeroing procedure as de...

Page 12: ...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 For optimal results do not place the adapter between the ET tube and the elbow 4 5Adapter Selection The matching disposable consumables adapter provided by our company are as follows Item number Patient situation C...

Page 13: ...terfaces Screen display Alarm mute button Menu button Power button Monitoring Mute Clear mute Enter menu Long press more than 2s power off Menu Up Plus confirm Down Minus 5 2 Monitoring The MEMO is equipped with a 128 128 pixel graphic TFT display that shows the end tidal carbon dioxide value respiratory rate value and the capnogram 5 2 1 EtCO2 The unit of end tidal carbon dioxide EtCO2 defaults t...

Page 14: ...ter setup menu 3 Select the setting item press the alarm mute button or the power button to select items 4 Enter editing mode press menu button to enter editing mode 5 Adjust the setting value press the alarm mute button or the power button to adjust the values 6 Exit the edit mode press the menu button to exit the edit mode 5 3 Indicators and alarms The CMZ60MEMO is equipped with an alarm status ...

Page 15: ...y beeps delay inherent in the determination of an ALARM CONDITION less than 1 second Active alarms are further displayed according to the following table Alarm Screen EtCO2 Value RR Value Apnea value steady flashing EtCO2 Low value flashing value steady EtCO2 High value flashing value steady RR Low value steady value flashing RR High value steady value flashing No Adapter N A N A Alarm Priority In...

Page 16: ...hen the alarm is muted the yellow alarm mute indicator is located in the upper right corner of the display i e the alarm status silence indicator will light Pressing the alarm mute button again during 2 minutes of silence will reactivate the audible alarm If a No Breath alarm is muted by pressing the Alarm Silence button the MEMO will automatically switch off after 2 minutes provided that no new b...

Page 17: ...nu button in the monitoring interface to enter the menu 2 Enter the alarm setting menu Press the alarm mute button or the power button to select the Alarm menu and then press the menu button to enter the selected menu 3 Select the alarm setting item Press the alarm mute button or the power button to select 4 Enter editing mode press menu button to enter editing mode 5 Adjust the alarm limit Press ...

Page 18: ... CMZ60MEMO Mainstream EtCO2 Sensor MEMO CSM01A Airway Adapter Needed in order for MEMO to provide readings 7 Maintenance 7 1 Battery replacement To replace the batteries 1 Push the battery cover release button to the position Then push down the battery cover and remove the battery cover 2 Gently remove the depleted batteries And then Insert two new AAA type batteries into the battery compartment M...

Page 19: ...d Accessories in this manual 7 4 Zeroing procedure Zeroing is recommended after replaced airway adapter or whenever an offset in gas readings is discovered Zeroing of the MEMO is performed by the following procedure 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...

Page 20: ... the MEMO 3 Turn on the MEMO and make sure the EtCO2 reading is zero Otherwise conduct a zeroing procedure according to Chapter 7 4 above before proceeding 4 Insert the 15M connector into one end of the airway adapter and connect a second airway adapter to the other end of the first airway adapter see Figure 10 5 Turn on the regulator flow 6 After 30 seconds record the EtCO2 reading 7 Turn off the...

Page 21: ...as NOTE The manufacturer can provide schematics component lists legends calibration details or other information that helps maintenance personnel repair equipment parts that can be serviced by maintenance personnel authorized by manufacturer 8 Specifications 8 1 General specifications Description Compact battery powered quantitative MEMO for mainstream CO2 monitoring of adult pediatric and infant ...

Page 22: ...he detection environment c can automatically monitor the airway blockage d can automatically monitor whether the gas sampling tube connection is complete e can automatically compensate for the detection error caused by atmospheric pressure f It can report three units of mmHg kPa 8 2 Interfering gas and vapor effects Gas or vapor Gas level Quantitative effects Nitrous oxide 60 N A Halothane 4 N A E...

Page 23: ... 2 1 5VDC Alkaline IEC LR03 or Energizer Ultimate Lithium L92 batteries Use of other Lithium batteries may present a risk of fire or explosion Battery life time Duracell plus alkaline 6 hours Energizer ultimate lithium L92 10 hours Duracell plus alkaline 4 hours Energizer ultimate lithium L92 8 hours 8 4 Classifications Category AP APG AP This device is not suitable for use in the presence of a fl...

Page 24: ...ay result in increased electromagnetic emission or decreased electromagnetic immunity of the patient monitoring equipment The device or its components should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the device or its components should be observed to verify normal operation in the configuration in which it will be used When the inputted signal ...

Page 25: ...c environment specified below The customer or the user of the EtCO2 Sensor should assure that it is used in such an environment IMMUNITY test IEC 60601 test level Compliance level Electrostatic discharge ESD IEC 61000 4 2 8 kV contact 15 kV air 8 kV contact 15 kV air Electrical fast transient burst IEC 61000 4 4 Not Applicable Surge IEC 61000 4 5 Not Applicable Voltage dips short interruptions and...

Page 26: ...t Frequency MHz Band a MHz Service a Modulation b Modulation b W Distance m IMMUNITY TEST LEVEL V m 385 380 390 TETRA 400 Pulse modulation b 18 Hz 1 8 0 3 27 450 380 390 GMRS 460 FRS 460 FM c 5 kHz deviation 1 kHz sine 2 0 3 28 710 704 787 LTE Band 13 17 Pulse modulation b 217 Hz 0 2 0 3 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse modulation b 18 Hz 2 0 3 28 870 ...

Page 27: ...e worst case The MANUFACTURER should consider reducing the minimum separation distance based on RISK MANAGEMENT and using higher IMMUNITY TEST LEVELS that are appropriate for the reduced minimum separation distance Minimum separation distances for higher IMMUNITY TEST LEVELS shall be calculated using the following equation E Where P is the maximum power in W d is the minimum separation distance in...