Handleiding Contec CMS50D1 Pulse-oxymeter

Handleiding

Instructions to User

Dear Users, thank you very much for purchasing our product.

This Manual is written and compiled in accordance with the council directive MDD93/42/EEC for medical

devices and harmonized standards. The Manual is written for the current Pulse Oximeter. 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 Manual very carefully before using this equipment. These instructions describe the operating

procedures to be followed strictly, failure to follow these instructions can cause measuring abnormality,

equipment damage and personal injury. The manufacturer is NOT responsible for the safety, reliability and

performance issues and any monitoring abnormality, personal injury and equipment damage due to user’s

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, and can be used repeatedly. Its using life is 3 years.

WARNING:

 The uncomfortable or painful feeling may appear if using the device ceaselessly, especially for the

microcirculation barrier patients. It is recommended that the sensor should not be applied to the

same finger for over 2 hours.

 For the individual patients, there should be a more prudent inspecting in the placing process. The

device can not be clipped on the edema and tender tissue.

 The light (the infrared is invisible) emitted from the device is harmful to the eyes, so the user and

the maintenance man, can not stare at the light.

 Testee can not use enamel or other makeup.

 Testee’s fingernail can not be too long.

 Please peruse the relative content about the clinical restrictions and caution.

 This device is not intended for treatment.

The User Manual is published by our company. All rights reserved.

1 Safety

1.1 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 about cables and transducers. It is recommended

that the device should be inspected once a week at least. When there is obvious damage, stop using the

monitor.



Necessary maintenance must be performed by qualified service engineers ONLY. Users are not

permitted to maintain it by themselves.



The oximeter cannot be used together with devices not specified in User’s Manual.Only the accessory

that appointed or recommendatory by manufacture can be used with this device.



This product is calibrated before leaving factory.

1.2 Warnings

 Explosive hazard—DO NOT use the oximeter in environment with inflammable gas such as some

ignitable anesthetic agents.

 DO NOT use the oximeter while the testee measured by MRI and CT.

 The person who is allergic to rubber can not use this device.

 The disposal of scrap instrument and its accessories and packings(including battery, plastic bags, foams

and paper boxes) should follow the local laws and regulations.

 Please check the packing before use to make sure the device and accessories are totally in accordance

with the packing list, or else the device may have the possibility of working abnormally.

 Please don't measure this device with function test paper for the device's related information.

1.3 Attentions

 Keep the oximeter away from dust, vibration, corrosive substances, explosive materials, high

temperature and moisture.

 If the oximeter gets wet, please stop operating it.

 When it is carried from cold environment to warm or humid environment, please do not use it

immediately.

 DO NOT operate keys on front panel with sharp materials.

 High temperature or high pressure steam disinfection of the oximeter is not permitted. Refer to User

Manual in the relative chapter for instructions of 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℃.

 As to the fingers which are too thin or too cold, it would probably affect the normal measure of the

patients' SpO

2

and pulse rate, please clip the thick finger such as thumb and middle finger deeply enough

into the probe.

 Do not use the device on infant or neonatal patients.

 The product is suitable for children above four years old and adults(Weight should be between 15kg to

110kg).

 The device may not work for all patients. If you are unable to achieve stable readings, discontinue use.

 The update period of data is less than 5 seconds, which is changeable according to different individual

pulse rate.

 The waveform is normalized.Please read the measured value when the waveform on screen is equably

and steady-going, Here this measured value is optimal value. And the waveform at the moment is the

standard one.

 If some abnormal conditions appear on the screen during test process, pull out the finger and reinsert to

restore normal use.

 The device has normal useful life for three years since the first electrified use.

 The hanging rope attached the product is made from Non- allergy material, if particular group are

sensitive to the hanging rope, stop using it. In addition, pay attention to the use of the hanging rope , do

not wear it around the neck avoiding cause harm to the patient.

 The instrument dose not have low-voltage alarm function, it only shows the low-voltage,please change

the battery when the battery energy is used out.

 When the parameter is particularly, The instrument dose not have alarm function.Do not use the device in

situations where alarms are required.

 Batteries must be removed if the device is going to be stored for more than one month, or else batteries

may leak.

 A flexible circuit connects the two parts of the device. Do not twist or pull on the connection.

2 Overview

The pulse oxygen saturation is the percentage of HbO

2

in the total Hb in the blood, so-called the O

2

concentration in the blood. It is an important bio-parameter for the respiration. For the purpose of measuring the

SpO

2

more easily and accurately, our company developed the Pulse Oximeter. At the same time, the device can

measure the pulse rate simultaneously.

I

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