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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 ,...
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;...
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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!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.
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.
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 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.
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.
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.
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: —...
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...
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):...
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...
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.
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.
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.
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.
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...
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.
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.
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...
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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...
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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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