Contec CMS 50IW Manuel utilisateur

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Pols saturatiemeter

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.

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

III

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.

The light (the infrared is invisible) emitted from the device is

harmful to the eyes, so the user and the maintenance man should not

look at the light source.

Testee can not use enamel or other makeup.

Testee’s fingernail can not be too long.

Please refer to the correlative literature about the clinical

restrictions and caution.

This device is not intended for treatment.

Contents

1 Safety...................................................................................................1

1.1 Instructions for safe operations......................................................1

1.2 Warning .........................................................................................1

1.3 Attention........................................................................................2

2 Overview..............................................................................................4

2.1 Features..........................................................................................4

2.2 Major applications and scope of application..................................4

2.3 Environment requirements.............................................................5

3 Principle ..............................................................................................6

4 Technical specifications.....................................................................7

4.1 Main performance..........................................................................7

4.2 Main parameters ............................................................................7

5 Installation...........................................................................................8

5.1 View of the front panel...................................................................8

5.2 Probe installation ...........................................................................9

5.3 Accessories....................................................................................9

6 Operating guide .................................................................................9

6.1 Application method........................................................................9

6.2 Attention for operation.................................................................17

6.3 Clinical restrictions......................................................................18

7 Maintain, transportation and storage ..........................................19

7.1 Cleaning and disinfecting.............................................................19

7.2 Maintain.......................................................................................19

7.3 Transportation and storage...........................................................19

8 Troubleshooting ................................................................................20

9 Key of symbols................................................................................22

10 Function specification....................................................................24

Appendix 1 .............................................................................................25

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. 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.

The oximeter cannot be used together with devices not specified in

User’s Manual. Only the accessory that is appointed or recommendatory

by manufacture can be used with this device.

This product is calibrated before leaving factory.

1.2 Warning

Explosive hazard—DO NOT use the oximeter in the environment

with tinder such as anesthetic .

DO NOT use the oximeter while the patient is being scanned by

MRI or CT.

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

The disposal of scrap instrument and its accessories and packing

(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 choose the accessories which are appointed or

recommended by the manufacturer for avoiding device damage.

Please don't measure this device with functional tester for the

device's related information.

1.3 Attention

֠Keep the oximeter away from dust, vibration, corrosive substances,

tinder, high temperature and moisture.

֠If the oximeter gets wet, please stop operation.

֠When it is carried from cold environment to warm or humid

environment, please do not use it immediately.

֠DO NOT operate button on front panel with sharp things.

֠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.

֠The fingers which are too thin or too cold may affect the measure

accuracy , please clip the thicker finger such as thumb and middle finger

deeply enough into the probe.

֠The oximeter probe which is optional can be used to children.

֠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 the finger out and reinsert to restore normal use.

֠The device has normal life for three years since the first electrified

use.

֠The device has alarm function, this function can either be paused, or

closed (default setting) for good.Please check the chapter 6.1 as reference.

֠The device has the function of beyond limit alarm.When the

measure data is beyond the highest or lowest limit, the device would start

alarm automatically on the premise of the alarming function is on.

֠The device may be not fit for all patients. If you are unable to

receive approving measure, discontinue use.

֠Do not contort or drag the wire of the device.

2 Overview

The pulse oxygen saturation is the percentage of HbO

in the total Hb in the

blood, so-called the O

concentration in the blood. It is an important

bio-parameter for the respiration. A number of diseases relating to

respiratory system may cause the decrease of SpO

in the blood,

furthermore, some other causes such as the malfunction of human body's

self-adjustment, damages during surgery, and the injuries caused by some

medical checkup would also lead to the difficulty of oxygen supply in

human body, and the corresponding symptoms would appear as a

consequence, such as vertigo, impotence, vomit etc. Serious symptoms

might bring danger to human's life. Therefore, prompt information of

patients' SpO

is of great help for the doctor to discover the potential

danger, and is of great importance in the clinical medical field.

The Pulse Oximeter is small in volume,low in power

consumption,convenient in operation and portable. With high-definition

display screen,the device is concise and fashion.It is only necessary for

patient to put one finger into probe for diagnosis, and the display screen will

directly show the SpO

value,pulse rate value,Perfusion Index value and

pulse waveform with the high veracity and repetition.

2.1 Features

AUltra-thin wrist-design,concise and fashion.

BSmall in volume, light in weight and convenient in carrying.

CLow power consumption

DDisplay direction can be changed,easy to view.

EPerfusion Index measure.

F Wireless data communication

2.2 Major applications and scope of application

The Pulse Oximeter can be used in measuring the pulse oxygen saturation,

pulse rate and perfusion index 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.

The problem of overrating would emerge when the patient is

suffering from toxicosis which caused by carbon monoxide, the device

is not recommended to be used under this circumstance.

2.3 Environment requirements

Storage Environment

a) Temperature :-40~+60

b) Relative humidity :≤95%

c) Atmospheric pressure :500hPa~1060hPa

Operating Environment

a) Temperature:10~40

b) Relative Humidity :≤75%

c) Atmospheric pressure:700hPa~1060hPa

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