Contec CMS-50D Plus Manual de usuario

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:

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 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 stare at the light.

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.

The User Manual is published by our company. All rights

reserved.

III

CONTENTS

1 SAFETY.....................................................................1

1.1 INSTRUCTIONS FOR SAFE OPERATIONS...............1

1.2 WARNING ...........................................................1

1.3 ATTENTION.........................................................3

2 OVERVIEW ..............................................................6

2.1 CLASSIFICATION:................................................6

2.2 FEATURES...........................................................7

2.3 MAJOR APPLICATIONS AND SCOPE OF

APPLICATION..............................................................7

2.4 ENVIRONMENT REQUIREMENTS .........................7

3 PRINCIPLE...............................................................9

4 TECHNICAL SPECIFICATIONS..........................10

4.1 MAIN PERFORMANCE .......................................10

4.2 MAIN PARAMETERS..........................................10

5 INSTALLATION.....................................................12

5.1 VIEW OF THE FRONT PANEL..............................12

5.2 BATTERY INSTALLATION...................................12

5.3 ACCESSORIES ...................................................13

6 OPERATING GUIDE..............................................14

6.1 APPLICATION METHOD.....................................14

6.2 ATTENTION FOR OPERATION.............................22

6.3 CLINICAL RESTRICTIONS..................................23

7 MAINTAIN, TRANSPORTATION AND STORAGE25

7.1 CLEANING AND DISINFECTING .........................25

7.2 MAINTAIN.........................................................25

7.3 TRANSPORTATION AND STORAGE .....................25

8 TROUBLESHOOTING ..........................................26

9 KEY OF SYMBOLS................................................28

10 FUNCTION SPECIFICATION ............................31

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 device. In addition ,the overall

check of monitor, including the safety check such as the

leakage current ,should be performed only by qualified

personnel once every 12 months.

Necessary maintenance must be performed by

qualified service engineers ONLY. There are no user

serviceable parts and 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 Warning

Explosive hazard—DO NOT use the oximeter in

environment with inflammable gas such as some

ignitable anesthetic agents.

Ensure that the environment in which the device is

operated is not subject to any sources of strong

electromagnetic interference, such as radio transmitters,

mobile telephones, etc. Keep them far away High level

electromagnetic radiation emitted from such devices

may greatly affect the monitor performance.

DO NOT use the oximeter while the testee measured

by MRI and CT.

Be careful with the use of the lanyard cord. Improper

use of the lanyard cord will cause device damage not

covered under the manufacturer’s warranty. Swinging

the device by the lanyard cord will void the warranty.

Please do not use lanyard cord if allergic to lanyard

cord.

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 choose the accessories and probe which are

approved or manufactured by the manufacturer, or else

it may damage the device.

Please don't measure this device with functional tester

for the device's related information.

When uploading, do keep the patient form touching the

USB port. The computer used when uploading must be

in accordance with EN60950. In addition, when the

data line connected to a computer, the medical

electrical systems should be in accordance with

IEC60601-1-1.

1.3 Attention

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 (7.1)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' SpO2and pulse rate, please clip the thick

finger such as thumb and middle finger deeply enough

into the probe.

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 to the device 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 on the purpose of avoiding harm to the

patient.

This device has the function of alarming, users can

check on this function according to chapter 6.2 as a

reference.

The device has the function of limits alarming, when

the measured data is beyond the highest or lowest limit,

the device would start alarming automatically on the

premise of the alarming function is on.

The device has the function of alarming, this function

can either be paused, or closed (default setting) for

good. This function could be turned on through menu

operation if you need.Please check the chapter 6.2 as a

reference.

The device may not work for all patients. If you are

unable to achieve stable readings, discontinue use.

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 HbO2in the

total Hb in the blood, so-called the O2concentration 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 SpO2in 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' SpO2is of great help for the doctor

to discover the potential danger, and is of great importance

in the clinical medical field.

The Pulse Oximeter features in small volume, low power

consumption, convenient operation and being portable.It is

only necessary for patients to put one of his fingers into a

probe for diagnosis, and a display screen will directly show

the measured value of pulse oxygen saturation with the high

veracity and repetition.

2.1 Classification:

Class II b(MDD93/42/EEC IX Rule 10)

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