Contec CMS50M User Manual

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Sa02 and Sp02

Pules rate Bargraph Dispaly

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Figure 3 Bland-Altman plot

Figure 5.

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Figure 4. Front View

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Pules rate - - -......

The display Sp02

------1++++88

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Figure 2

SpOz regression plot

One hanging rope;

Two batteries

(optional);

One User Manual.

5 A c c e s s o r i e s .

6 Installation

6.1 View of the Front Panel

7 Operating Guide

6.2 Battery

Step 1. Insert the two AAA size batteries properly in the right direction.

Step 2. Put the cover.

~lease

take care when you insert the batteries for the improper insertion may damage the device.

6.3 Mounting the Hanging Rope

Step 1. Put the end of the rope through·the hole.

Step 2. Put another end of the rope through the first one and then tighten it.

4 Technical Specifications

Glow and Infrared-ray

Receipt Tube

instrument is: Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning & Recording

Technology~

that two beams of different wavelength of lights can be focused onto human nail tip through perspective clamp finger-type sensor. Then measured signal

can be obtained by a photosensitive element, information acquired through which will be shown on screen through treatment in electronic circuits and

microprocessor.

7.4 Press the switch button once on front panel.

7.5

Do not shake the fmger and keep the user at ease during the process. Meanwhile, human body is not recommended in movement status.

7.6 Get the information directly from screen display.

7.7 In boot-strap state,press button ,and the device is reset.

Fingernails and the luminescent tube should be on the same side.

Glow and Infrared-ray

Emission Tube

3.2 Caution

The finger should be placed properly (see the attached illustration of this manual ,Figure 7), or else it may cause inaccurate measurement.

The SpOz sensor and photoelectric receiving tube should be arranged in a way with the subject's arteriole in a position there between.

The SpOz sensor should not be used at a location or limb tied with arterial canal or blood pressure cuff or receiving intravenous injection.

Make sure the optical path is free from any optical obstacles like rubberized fabric.

Excessive ambient light may affect the measuring result. It includes fluorescent

lamp~

dual ruby

light~

infrared heater, direct sunlight and etc.

Strenuous action of the subject or extreme electrosurgical interference may also affect the accuracy.

User can not use enamel or other makeup.

3.3 Clinical Restrictions

As the measure is taken on the basis of arteriole pulse, substantial pulsating blood flow of subject is required. For a subject with weak pulse due to

shock, low ambientlbody temperature, major bleeding, or use of vascular contracting drug, the SpOz waveform (PLETH) will decrease. In this case,

the measurement will be more sensitive to interference.

For those with a substantial amount of staining dilution drug (such as methylene blue, indigo green and acid indigo blue), or carbon monoxide

hemoglobin (COHb), or methionine (Me+Hb) or thiosalicylic hemoglobin, and some with icterus problem, the SpOz determination by this monitor

may be inaccurate.

The drugs like dopamine, procaine, prilocaine, lidocaine and butacaine may also be a major factor blamed for serious error of SpOz measure.

As the SpOz value serves as a reference value for judgement of anemic anoxia and toxic

anoxia~

some users with serious anemia may also report

good SpOz measurement.

8 Re airing and Maintenance

7.1

Insert the two batteries properly to the direction, and then put the cover.

7.2 Open the clip.

7.3

Let the user's finger put into the rubber cushions of the clip (make sure the finger is in the right position), and then! clip the finger. As shown in

Figure 5

1) Display Format: Digital tube Display;

SpOz Measuring Range: 0% - 100%;

Pulse Rate Measuring Range: 30 bpm - 250 bpm;

Pulse Intensity Display: columniation display

Power Requirements: 2

1.5V AAA alkaline battery, adaptable range: 2.6V-3.6V.

Power Consumption: Smaller than 25

rnA.

4) Resolution: 1% for SpOz and 1 bpm for Pulse Rate.

5) Measurement Accuracy: ±2% in stage of 70%-100% SpOz, and meaningless when stage being smaller than 70%. ±2 bpm or±2% (select larger) for

Pulse Rate. Clinical Trial :SpOz regression plot & Bland-Altman plot,Refer to Figure 2 & Figure 3.

6) Measurement Performance in Weak Filling Condition: SpOz and pulse rate can be shown correctly when pulse-filling ratio is 0.4%. SpOz error is

±4%, pulse rate error is ±2 bpm or ±2% (select larger).

7) Resistance to surrounding light: The deviation between the value measured in the condition of man-made light, indoor natural light and that of

darkroom is less than ±l %.

It is equipped with a switch function. The Oxirpeter can be powered off when the finger is off the oximeter within 5 seconds.

9) Optical Sensor

Red light (wavelength is 660nm, 6.65mW)

Infrared (wavelength is 880nm, 6.75mW)

Figure 1. Operating Principle

Please change the batteries when the low-voltage displayed on the screen.

Please clean the surface of the device before using. Wipe the device with medical alcohol first, and then let it dry in air or clean it by dry clean fabric.

Using the medical alcohol to disinfect the product after use, prevent from cross infection for next time use.

Please take out the batteries if the oximeter is not in use for a long time.

The packed device can be transported by ordinary conveyance or according to transport contract.The device can not be transported mixed with toxic,

harmful, corrosive material.

The best storage environment of the device is - 40°C to 60°C ambient temperature and not higher than 95% relative humidity.

Users are advised to calibrate the device termly (or according to the calibrating program of hospital). It also can be performed at the state-appointed

agent or just contact us for calibration.

High-pressure sterilization cannot be used on the device.

Do not immerse the device in liquid.

It is recommended that the device should be kept in a dry environment. Humidity may reduce the useful life of the device, or even damage

File No.:CMS2.782.395(OCH)ESS/1.0

Release Date: June 2016

1.4.01.01.393

Address:

No.112 Qinhuang West Street, Economic &Technical Development Zone,

Qinhuangdao, Hebei Province, PEOPLE'S REPUBLIC OF CHINA

Tel:

0086-335-8015430

Fax: 0086-335-8015588

Technical support: 0086-335-8015431

E-mail: cms@contecmed.com.cn

contec88@gmail.com

Website: http://www.contecmed.com

CONTEC™

Contec Medical Systems Co., Ltd.

Instructions to User

recommended to be used under this circumstance.

The pulse oxygen saturation is the percentage of HbOz in the total Hb in the blood, so-called the Oz concentration in the blood. It is an important

bio-parameter for the respiration. For the purpose of measuring the SpOz more easily and accurately, our company developed the Pulse Oximeter. At the

same time, the device can measure the pulse rate simultaneously.

The Pulse Oximeter features in small volume, low power consumption, convenient operation and being portable. It is only necessary for user to put one of

his fmgers into a fingertip photoelectric sensor for diagnosis, and a display screen will directly show measured value of Hemoglobin Saturation.

2.1 Features

Operation of the product is simple and convenient.

The product is small in volume, light in weight (total weight is about 50g including batteries) and convenient in carrying.

Power consumption of the product is low and the two originally equipped AAA batteries can be operated continuously for 24 hours.

The product will automatically be powered off when no signal is in the product within 5 seconds.

Low - battery indicator as battery icon flash manner.

2.2 Major Applications and Scope of Application

The Pulse Oximeter can be used in measuring pulse oxygen saturation and pulse rate through finger. The product is suitable for family use(It can be used

before or after doing sports, and it is not recommended to use the device during the process of doing sports) .

The problem of overrating would emerge when the user is suffering from toxicosis which caused by carbon monoxide, the device is not

CMS50M

2 Overview

Dear users, thank you very much for purchasing the 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 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 can be used repeatedly. The operating life is 3 years.

If you have any questions regarding to the use of this product, please call us at 1-847-562-1702 Monday-Friday from 8:00 AM to 5:00 PM Eastern Time.

WARNING:

Uncomfortable or painful feeling may appear if using the device

cea~elessly,

especially for the the microcirculation barrier users. It is

recommended that the sensor should not be applied to the same finger for over 2 hours.

For the special users, 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.

User can not use enamel or other makeup.

User'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.

Pulse Oximeter

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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 user'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 oximeter .

Necessary maintenance must be performed by qualified 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.

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.

Parts of the device that are not serviced or maintained while in use with the user.

};- WarninKagainst servicing and maintenance while the me equipment is in use.

No modification of this equipment is allowed.

The user is an intended operator.

The probe of the device is the applied part.

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°C.

As to the fingers which are too thin or too cold, it would probably affect the normal measure of the users' Sp02 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 users.

The product is suitable for adults(Weight should be between 40kg to 1IOkg).

The device may not work for all users. Ifyou 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.

If some abnormal conditions appear on the screen during test process, pull out the finger and reinsert to restore normal 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 users.

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.

1.4.Indication for Use

The Pulse Oximeter is a non-invasive device intended for the spot-check of saturation of arterial hemoglobin(Sp02) and the pulse rate of adult in home

use environments.This device is not intended for continuous monitoring.The device can be multi-used.Solely for use with sporting and aviation

activities.Intended to monitor heart rate during exercise.

2.3 Environment Requirements

Storage Environment

a) Temperature

:-40°C~+60°C

b) Relative humidity

::::s

95%

c) Atmospheric pressure

:500hPa~1060hPa

Operating Environment