Gima OXY-2 Bedienungsanleitung

PULSOXIMETRO OXY-2

OXY-2 FINGER OXIMETER

OXYMÈTRE DE POULS OXY-2

PULSIOXÍMETRO OXY-2

OXÍMETRO DE PULSO OXY-2

ΠΑΛΜΙΚΌ ΌΞΎΜΕΤΡΌ OXY-2

Manuale d’uso - User manual

Manuel de l’utilisateur - Guía de uso

Guia para utilização - Οδηγίες χρήσης

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.

ATENCIÓN: Los operadores tienen que leer y entender completamente este manual

antes de utilizar el producto.

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

de usar o produto.

ΠΡΌΣΌΧΗ: Οι χειριστές αυτού του προϊόντος πρέπει να διαβάσουν και να

καταλάβουν πλήρως τις οδηγίες του εγχειριδίου πριν από την χρήση του.

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

gima@gimaitaly.com - export@gimaitaly.com

www.gimaitaly.com

M35072-M-Rev.1.10.19

35072 / CMS50DL 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)

Eiestrasse 80, 20537, Hamburg, Germany

IP22

+60°C

-40°C

95%

106kPa

50kPa

PROFESSIONAL MEDICAL PRODUCTS

18ENGLISH

Instructions to User

Dear users, thank you very much for purchasing the

Pulse Oximeter.

The Manual describes, in accordance with the Pulse Ox-

imeter’s features and requirements, main structure, func-

tions, 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 User Manual carefully before using this

product. The User Manual which describes the operat-

ing procedures should be followed strictly. Failure to fol-

low the User Manual may cause measuring abnormality,

equipment damage and human injury. The manufacturer

is NOT responsible for the safety, reliability and perfor-

mance 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 specic prod-

ucts 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 microcir-

culation barrier patients. It is recommended that the

sensor should not be applied to the same nger for

over 2 hours.

For the special patients, there should be a more pru-

dent 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

19 ENGLISH

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 ngernail can not be too long.

Please refer to the correlative literature about the clin-

ical restrictions and caution.

This device is not intended for treatment.

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

the order of a physician. The User Manual is published

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 moni-

tor.

• 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 reg-

ulations.

• 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 pos-

sibility 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, corro-

sive substances, explosive materials, high tempera-

ture 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 pa-

tients’ SpO2and pulse rate, please clip the thick n-

ger such as thumb and middle nger 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

ENGLISH

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.

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

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.

1.4 Indication for Use

The Fingertip Pulse Oximeter is a non-invasive device

intended for the spot-check of oxygen saturation of

arterial hemoglobin (SpO2) and the pulse rate of adult

and pediatric patients in home and hospital environ-

ments (including clinical use in internist/surgery, anes-

thesia, intensive care ect.).

This device is not intended for continuous monitoring.

ENGLISH

2 OVERVIEW

The pulse oxygen saturation is the percentage of HbO2

in the total Hb in the blood, so-called the O2concen-

tration 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 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 conven-

ient 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 ash manner.

2.2 Major Applications and Scope of Application

The Pulse Oximeter can be used to measure human He-

moglobin Saturation and pulse rate through nger, and

indicate the pulse intensity by the bar-display.

The product is suitable for use in family, hospital (Ordi-

nary sickroom ), Oxygen Bar, social medical organiza-

tions and also the measure of saturation oxygen and

pulse rate.

ENGLISH

The product is not suitable for use in continu-

ous supervision for patients.

The problem of overrating would emerge

when the patient is suffering from toxicosis

which caused by carbon monoxide, the de-

vice is not recommended to be used under

this circumstance.

2.3 Environment Requirements

Storage Environment

a) Temperature: -40°C~+60°C

b) Relative humidity: ≤95%

c) Atmospheric pressure: 500hPa~1060hPa

Operating Environment

a) Temperature: 10°C~40°C

b) Relative Humidity: ≤75%

c) Atmospheric pressure: 700hPa~1060hPa

3 PRINCIPLE AND CAUTION

3.1 Principle of Measurement

Principle of the Oximeter is as follows: An experience

formula of data process is established taking use of

Lambert Beer Law according to Spectrum Absorption

Characteristics of Reductive Hemoglobin (Hb) and

Oxyhemoglobin (HbO2) in glow & near-infrared zones.

Operation principle of the instrument is: Photoelectric

Oxyhemoglobin Inspection Technology is adopted in

accordance with Capacity Pulse Scanning & Recording

Technology, so that two beams of different wavelength

of lights can be focused onto human nail tip through per-

spective clamp nger-type sensor.

Then measured signal can be obtained by a photosensi-

tive element, information acquired through which will be

shown on screen through treatment in electronic circuits

and microprocessor.

ENGLISH

Figure 1. Operating Principle

3.2 Caution

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

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

may cause inaccurate measurement.

2. The SpO2sensor and photoelectric receiving tube

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

ole in a position there between.

3. The SpO2sensor 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

obstacles like rubberized fabric.

5. Excessive ambient light may affect the measuring

result. It includes uorescent lamp, dual ruby light,

infrared heater, direct sunlight and etc.

6. Strenuous action of the subject or extreme electro-

surgical 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

pulse, substantial pulsating blood ow of subject is

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

low ambient/body temperature, major bleeding, or

use of vascular contracting drug, the SpO2waveform

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

Glow and Infrared-ray

Emission Tube

Glow and Infrared-ray

Receipt Tube

ENGLISH

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, li-

docaine and butacaine may also be a major factor

blamed for serious error of SpO2measure.

4. As the SpO2value serves as a reference value for

judgement of anemic anoxia and toxic anoxia, some

patients with serious anemia may also report good

SpO2measurement.

4 TECHNICAL SPECIFICATIONS

1.Display Format: Digital tube Display

SpO2Measuring Range: 0% - 100%

Pulse Rate Measuring Range: 30 bpm - 250 bpm

Pulse Intensity Display: columniation display

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

adaptable range: 2.6V~3.6V

3.Power Consumption: Smaller than 25 mA

4.Resolution: 1% for SpO2and 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 or ±2% (select larger) for Pulse Rate.

6.Measurement Performance in Weak Filling

Condition: SpO2and pulse rate can be shown cor-

rectly when pulse-lling ratio is 0.4%. SpO2error is

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

7.Resistance to surrounding light: The deviation be-

tween 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 Oximeter can

be powered off in case no nger is in the device.

ENGLISH

9.Optical Sensor

Red light (wavelength is 660nm, 6.65mW)

Infrared (wavelength is 880nm, 6.75mW)

Optical sensor is a light-emitting component,

which will affect other medical devices ap-

pling the same wavelength range.

5 ACCESSORIES

• One hanging rope

• Two batteries (optional)

• One User Manual

6 INSTALLATION

6.1 View of the Front Panel

Figure 2. Front View

Figure 3. Batteries Installation

The display SpO2

Low voltage display

Power switch

Pulse rate

bargraph display

ENGLISH

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