Specifications

ManualsBrandsMEDIPREVENTIECENTRUM ManualsBlood Glucose MeterPulse Oximeter

MEDIPREVENTIECENTRUM

Bestel in onze webshop. Telefoon: 074-2911110 (klantenservice)

Internet: http://www.medipreventiecentrum.nl E-mail: info@medipreventiecentrum.nl

Instructions to User

Dear users, thank you very much for purchasing the Pulse Oximeter.

This Manual is written and compiled in accordance with the

council directive MDD93/42/EEC for

medical devices and harmonized standards. In case of modifications and software upgrades, the

information contained in this document is subject to change without notice.

The Manual describes, in accordance with the Pulse Oximeter’s features and requirements, main

structure, functions, specifications, correct methods for transportation, installation, usage, operation,

repair, maintenance and storage, etc. As well as the safety procedures to protect both the user and

equipment. Refer to the respective chapters for details.

Please read the User Manual carefully before using this product.The User Manual which describes

the operating procedures should be followed strictly. Failure to follow the User Manual may cause

measuring abnormality, equipment damage and human injury. The manufacturer is NOT responsible

for the safety, reliability and performance issues and any monitoring abnormality, human injury and

equipment damage due to users' negligence of the operation instructions. The manufacturer’s

warranty service does not cover such faults.

Owing to the forthcoming renovation, the specific products you received may not be totally in

accordance with the description of this User Manual. We would sincerely regret for that.

This product is medical device, which can be used repeatedly.

Telefoon: 074-2911110 (klantenservice)

Bestel in onze webshop

Internet: www.medipreventiecentrum.nl E-mail: info@medipreventiecentrum.nl

Summary of content (16 pages)

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Telefoon: 074-2911110 (klantenservice) Bestel in onze webshop Internet: www.medipreventiecentrum.nl E-mail: info@medipreventiecentrum.nl Instructions to User Dear users, thank you very much for purchasing the Pulse Oximeter. This Manual is written and compiled in accordance with the council directive MDD93/42/EEC for medical devices and harmonized standards. In case of modifications and software upgrades, the information contained in this document is subject to change without notice.
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WARNING: Discomfort or pain may appear if using the device ceaselessly, especially for the microcirculation barrier patients. It is recommended that the pulse oximeter should not be used on the same finger for more than 2 hours. For the special patients, there should be a more prudent inspecting in the placing process. The device can not be clipped on the edema and tender tissue.
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Contents 1 Safety .............................................................................................................................................. 1 1.1 Instructions for Safe Operations .............................................................................................. 1 1.2 Warning .................................................................................................................................... 1 1.3 Attention ...................................................
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1 1.1 Safety Instructions for Safe Operations Check the main unit and all accessories periodically to make sure that there is no visible damage that may affect patient’s safety and monitoring performance. It is recommended that the device should be inspected weekly at least. When there is obvious damage, stop using the device. Necessary maintenance must be performed by qualified service engineers ONLY. Users are not permitted to maintain it by themselves.
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֠ High temperature or high pressure steam disinfection for the oximeter is not permitted. Refer to User Manual in the relative chapter (7.1) for cleaning and disinfection. ֠ Do not have the oximeter immerged in liquid. When it needs cleaning, please wipe its surface with medical alcohol by soft material. Do not spray any liquid on the device directly. ֠ When cleaning the device with water, the temperature should be lower than 60 .
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2.2 Major Applications and Scope of Application The Pulse Oximeter can be used in measuring the pulse oxygen saturation and pulse rate through finger.The product is fit for family, hospital, oxygen bar, community healthcare, physical care in sports (It can be used before or after doing sports and it is not recommended to use the device during the process of having sport) and etc.
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is due to low-power. Pulse sound indication With alarm function 4.2 Main Parameters A Measurement of SpO2 Measuring range: 0%~100 Accuracy: 70~100%: ±2%; Below 70%: unspecified. B Measurement of pulse rate Measuring range: 30bpm~250bpm Accuracy: ±2 bpm or ±2% (select larger) C Resolution SpO2: 1%, Pulse rate: 1bpm D Measurement Performance in Weak Filling Condition: SpO2 and pulse rate can be shown correctly when pulse-filling ratio is 0.4%.
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5.2 Battery Installation Figure 3 Battery installation A. . Refer to the polarity and put the edge of the battery on the mouth of the battery box, along the bottom of the battery box, gently push the battery into the box until the whole battery has been in-place.(Refer to Figure 3) B. . Replace the cover. Please take care the polarity when you insert the battery for the improper insertion may damage the device. 5.3 Accessories A. B. C. D.
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Figure 4 Finger placement Fingernails and the luminescent tube should be in the same side. 6.1.2 Alarm Setting a. Alarm includes the alarm of measure data's going beyond the limits (When the SpO2 is below 90%, or the pulse rate is not between 50bpm and 120bpm, the alarm occurs), the alarm of low-power,the alarm of finger out of position. b. In the close state of alarm, press button to turn on/off pulse sound. c.
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measure of SpO2 , pulse rate. F.Excessive ambient light may affect measurement accuracy. It includes fluorescent lamp, dual ruby light, infrared heater, direct sunlight and etc. G.Intense activity of the subject or extreme electrosurgical interference may also affect the accuracy. H.Testee can not use enamel or other makeup. I. Please clean and disinfect the device after operating according to the User Manual (7.1). 6.3 Clinical Restrictions A.
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8 Troubleshooting Trouble The SpO2 and Pulse Rate can not be displayed normally. The SpO2 and Pulse Rate are not displayed stably. The device can not be turned on. The display is off suddenly The device can not be used for full time after charge The battery can not be full charged even after 10 hours charging time. 9 Possible Reason Solution The finger is not properly positioned. Place the finger properly and try again. The patient’s SpO2 is too low to be detected.
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The pulse sound indication Type BF IP22 International Protection European Representative WEEE (2002/96/EC) This item is compliant with Medical Device Directive 93/42/EEC of June 14, 1993, a directive of the European Economic Community. battery positive electrode battery cathode electrode MEDIPREVENTIECENTRUM Bestel in onze webshop. Telefoon: 074-2911110 (klantenservice) Internet: http://www.medipreventiecentrum.nl E-mail: info@medipreventiecentrum.
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10 Function Specification Information Display Mode The Pulse Oxygen Saturation(SpO2) 2-digit digital LCD display Pulse Rate(PR) 3-digit digital LCD display Pulse Intensity (bar-graph) bar-graph LCD display SpO2 Parameter Specification Measuring range 0%~100%, (the resolution is 1%). Accuracy 70%~100%:±2% ,Below 70% unspecified.
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Appendix 1 Guidance and manufacture’s declaration – electromagnetic immunity – for all EQUIPMENT and SYSTEMS Guidance and manufacture’s declaration – electromagnetic immunity The CMS50QA Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of CMS50QA Pulse Oximeter should assure that it is used in such an environment.
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Guidance and manufacturer’s declaration – electromagnetic immunity – for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacturer’s declaration – electromagnetic immunity The CMS50QA Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of CMS50QA Pulse Oximeter should assure that it is used in such an environment.
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Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM – for EQUIPMENT or SYSTEM that are not LIFE-SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the CMS50QA PULSE OXIMETER The CMS50QA Pulse Oximeter is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.