Gima OXY-0 CMS50Q1 Bedienungsanleitung

PULSOXIMETRO PEDIATRICO OXY-0

OXY-0 PEDIATRIC OXIMETER

OXYMÈTRE PÉDIATRIQUE OXY-0

OXÍMETRO PEDIÁTRICO OXY-0

OXY-0 PEDIATRIC OXYMETER

OXY-0 PULSOXIMETRU PEDIATRIC

Importato da / Imported by / Importé par / Importado por /

Importat de / Importerad av:

Gima S.p.A. Via Marconi, 1 - 20060 Gessate (MI) Italy

gima@gimaitaly.com - export@gimaitaly.com

www.gimaitaly.com

M35056-M-Rev.0.02.23

CMS50Q1 (GIMA 35056)

0123

CONTEC MEDICAL SYSTEMS CO., LTD

No.112 Qinhuang West Street,

Economic & Technical Development Zone, Qinhuangdao,

Hebei Province, PEOPLE’S REPUBLIC OF CHINA

Made in China

Shanghai International Holding Corp. GmbH (Europe)

Eiffestrasse 80, 20537, Hamburg, Germany

IP22

+60°C

-40°C

95%

1060hPa

500hPa

PROFESSIONAL MEDICAL PRODUCTS

ATTENZIONE: Gli operatori devono leggere e capire completamente questo manuale prima di

utilizzare il prodotto.

ATTENTION: The operators must carefully read and completely understand the present manual

before using the product.

AVIS: Les opérateurs doivent lire et bien comprendre ce manuel avant d’utiliser le produit.

ATENÇÃO: Os operadores devem ler e entender completamente este manual antes de usar o

produto.

FÖRSIKTIGHET: Operatörer måste läsa och helt förstå denna manual innan produkten används.

ATENȚIE: Operatorii trebuie să citească și să înțeleagă pe deplin acest manual înainte de a

utiliza produsul.

24ENGLISH

Pulse Oximeter

CMS50Q1

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 modi-

cations and software upgrades, the information contained

in this document is subject to change without notice.

The Manual describes, in accordance with the Pulse Oxi-

meter’s features and requirements, main structure, fun-

ctions, specications, 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, equip-

ment damage and personal injury. The manufacturer is

NOT responsible for the safety, reliability and performan-

ce issues and any monitoring abnormality, personal injury

and equipment damage due to user’s negligence of the

operation instructions. The manufacturer’s warranty ser-

vice does not cover such faults.

Owing to the forthcoming renovation, the specic pro-

ducts 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 repeate-

dly. Its using life is 3 years..

WARNING:

25 ENGLISH

0The uncomfortable or painful feeling may appear if

using the device ceaselessly, especially for the micro-

circulation barrier patients. It is recommended that the

sensor should not be applied to the same nger for

over 2 hours.

0For 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.

0The light (the infrared is invisible) emitted from the de-

vice is harmful to the eyes, so the user and the main-

tenance man, can not stare at the light.

0Testee can not use enamel or other makeup.

0Testee’s ngernail can not be too long.

0Please peruse the relative content about the clinical

restrictions and caution.

0This device is not intended for treatment.

Caution: Federal law restricts this device to sale by or on

the order of a physician.

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 af-

fect patient’s safety and monitoring performance about

cables and transducers. It is recommended that the de-

vice should be inspected once a week at least. When

there is obvious damage, stop using the monitor.

• Necessary maintenance must be performed by quali-

ed service engineers ONLY. Users are not permitted to

maintain it by themselves.

• The oximeter cannot be used together with devices

not specied 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 envi-

ronment with inammable 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 regula-

tions.

• 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 possi-

bility of working abnormally.

• Please don’t measure this device with function test pa-

per for the device’s related information.

1.3 Attentions

Keep the oximeter away from dust, vibration, corrosi-

ve 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 ma-

terials.

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 ngers which are too thin or too cold, it would

probably affect the normal measure of the patients’

SpO2 and pulse rate, please clip the thick nger such as

thumb and middle nger deeply enough into the probe.

ENGLISH

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

The product is suitable for children (Weight should be

between 10 kg to 40kg).

Prevent children from swallowing the product or its ac-

cessories.For children users, please use the product

under the condition of adult guardianship

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 measu-

red 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 stan-

dard one.

If some abnormal conditions appear on the screen

during test process, pull out the nger and reinsert to

restore normal use.

The device has normal useful life for three years since

the rst electried 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 at-

tention 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 fun-

ction, 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 exible circuit connects the two parts of the device.

Do not twist or pull on the connection.

1.4 Indication for Use

ENGLISH

The Pulse Oximeter is a non-invasive device intended

for the spot-check of saturation of arterial hemoglobin(-

SpO2) and the pulse rate of children in home use en-

vironments.This device is not intended for continuous

monitoring.The device can be multi-used.Pulse oximeter

intended for wellness use.

2 Overview

The pulse oxygen saturation is the percentage of HbO2

in the total Hb in the blood, so-called the O2 concentra-

tion in the blood. It is an important bio-parameter for the

respiration. For the purpose of measuring the SpO2 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 patient to put one of his ngers

into a ngertip photoelectric sensor for diagnosis, and a

display screen will directly show measured value of He-

moglobin Saturation.

2.1 Classiﬁcation

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

2.2 Features

• SpO2 value display, Pulse rate value display, bar graph

display, Pulse waveform display

• The display mode can be changed

• Screen brightness can be changed

• Power consumption of the product is low and the two

originally equipped AAA batteries can be operated con-

tinuously for 20 hours.

• The product will enter standby mode when no signal is

in the product within 5 seconds.

2.3 Major Applications and Scope

of Application

The Pulse Oximeter can be used to measure human He-

moglobin Saturation and pulse rate through nger, and

ENGLISH

indicate the pulse intensity by the bar-display. The product

is suitable for use in family, hospital (Ordinary sickroom),

Oxygen Bar, social medical organizations and also the

measure of saturation oxygen and pulse rate.

The product is not suitable for use in continuo-

us supervision for patients..

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.

2.4 Environment Requirements

Storage Environment

a) Temperature: -40°C ~ +60°C

b) Relative humidity: ≤95%

c) Atmospheric pressure: 500 hPa ~ 1060 hPa

Operating Environment

a) Temperature: 10°C ~ 40°C

b) Relative Humidity: ≤75%

c) Atmospheric pressure: 700 hPa ~ 1060 hPa

3 Principle and Caution

3.1 Principle of Measurement

Principle of the Oximeter is as follows: An experience for-

mula of data process is established taking use of Lambert

Beer Law according to Spectrum Absorption Characteri-

stics of Reductive Hemoglobin (Hb) and Oxyhemoglobin

(HbO2) in glow & near-infrared zones. Operation principle

of the instrument is: Photoelectric Oxyhemoglobin In-

spection Technology is adopted in accordance with Capa-

city Pulse Scanning & Recording Technology, so that two

beams of different wavelength of lights can be focused

onto human nail tip through perspective clamp nger-type

sensor. Then measured signal can be obtained by a pho-

tosensitive element, information acquired through which

will be shown on screen through treatment in electronic

circuits and microprocessor

ENGLISH

Glow and Infrared-ray

Emission Tube

Glow and Infrared-ray

Receipt Tube

Figure 1 Operating principle

3.2 Precautions

1. The nger should be placed properly (see the atta-

ched illustration of this manual, Figure 5), or else it

may cause inaccurate measurement.

2. The SpO2 sensor and photoelectric receiving tube

should be arranged in a way with the subject’s arterio-

le in a position there between.

3. The SpO2 sensor should not be used at a location or

limb tied with arterial canal or blood pressure cuff or

receiving intravenous injection.

4. Make sure the optical path is free from any optical ob-

stacles like rubberized fabric.

5. Excessive ambient light may affect the measuring re-

sult. It includes uorescent lamp, dual ruby light, infra-

red heater, direct sunlight and etc.

6. Strenuous action of the subject or extreme electrosur-

gical interference may also affect the accuracy.

7. Testee can not use enamel or other makeup.

3.3 Clinical Restrictions

1. As the measure is taken on the basis of arteriole pul-

se, substantial pulsating blood ow of subject is re-

quired. For a subject with weak pulse due to shock,

low ambient/body temperature, major bleeding, or

use of vascular contracting drug, the SpO2 waveform

ENGLISH

(PLETH) will decrease. In this case, the measurement

will be more sensitive to interference.

2. For those with a substantial amount of staining dilu-

tion drug (such as methylene blue, indigo green and

acid indigo blue), or carbon monoxide hemoglobin

(COHb), or methionine (Me+Hb) or thiosalicylic he-

moglobin, and some with icterus problem, the SpO2

determination by this monitor may be inaccurate.

3. The drugs like dopamine, procaine, prilocaine, lidocai-

ne and butacaine may also be a major factor blamed

for serious error of SpO2 measure.

4. As the SpO2 value serves as a reference value for

judgement of anemic anoxia and toxic anoxia, some

patients with serious anemia may also report good

SpO2 measurement.

4 Technical Speciﬁcations

1. Display Format: LCD Display; SpO2 Measuring

Range: 0% ~ 100%; Pulse Rate Measuring Range:

30 bpm ~ 250 bpm; Pulse Wave Display: columniation

display and the waveform display.

2. Power Requirements: 2×1.5 V AAA alkaline battery

(or using the rechargeable battery instead),adaptable

range: 2.6 V - 3.6 V.

3. Power Consumption: Smaller than 30 mA.

4. Resolution: 1% for SpO2 and 1 bpm for Pulse Rate.

5. Measurement Accuracy: ±2% in stage of 70% ~ 100%

SpO2, and meaningless when stage being smaller

than 70%. ±2 bpm during the pulse rate range of 30

bpm ~ 99 bpm and ±2% during the pulse rate range of

100 bpm ~ 250 bpm .

6. Measurement Performance in Weak Filling Condition:

SpO2 and pulse rate can be shown correctly when

pulse-lling ratio is 0.4%. SpO2 error is ±4%, pulse

rate error is ± 2 bpm during the pulse rate range of 30

bpm ~ 99 bpm and ±2% during the pulse rate range of

100 bpm ~ 250 bpm .

7. Resistance to surrounding light: The deviation betwe-

ENGLISH

en the value measured in the condition of man-made

light or indoor natural light and that of darkroom is less

than ±1%.

8. It is equipped with a function switch: The product will

enter standby mode when no signal is in the product

within 5 seconds.

9. Optical Sensor:

Red light (wavelength is 660 nm, 6.65 mW) Infrared

(wavelength is 880 nm, 6.75 mW)

5 Accessories

One hanging rope;

Two batteries(optional)

One User Manual.

6 Installation

6.1 View of the Front Panel

Figure 2 Front view

ENGLISH

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