Gima 35093 Manualul proprietarului

Marca: Gima

Model: 35093

Tip: Manualul proprietarului

OXY-4 PULSE OXIMETER

PULSOXIMETRU

PULSOXIMETER

PULSSIOKSIMETRI

PULSNI OKSIMETAR

PULZOXIMÉTER

ПУЛСОВ ОКСИМЕТЪР

PULSOXYMETER

M35093-M-Rev.0-11.23

PROFESSIONAL MEDICAL PRODUCTS

ATTENTION: The operators must carefully read and

completely understand the present manual before

using the product.

AVERTISMENT: Orice accident grav produs, privitor la

dispozivul medical fabricat de rma noastră, trebuie

semnalat producătorului și autorității competente în sta-

tul membru pe teritoriul căruia își are sediul ulizatorul.

OBS: Det är nödvändigt a meddela llverkaren och de

behöriga myndigheterna i den berörda medlemsstaten,

om alla allvarliga olyckor som inträat i samband med

den medicintekniska utrustning som levererats av oss.

VAROITUS: Kaikista vakavista tapaturmista, jotka

liiyvät toimiamamme lääkinnällisen laieen käyöön,

on ilmoiteava valmistajalle sekä oman asuinpaikan

jäsenmaan toimivaltaiselle viranomaiselle

PAŽNJA: Potrebno je prijavi svaku ozbiljnu nezgodu

koja se dogodila u vezi s isporučenim medicinskim proiz-

vođaču i nadležnom jelu države članice u kojoj se nalazi.

Gima S.p.A.

Via Marconi, 1 - 20060 Gessate (MI) Italy

gima@gimaitaly.com - export@gimaitaly.com

www.gimaitaly.com

35093

0476

FIGYELEM: A gyártónak, illetve a székhely szerin

tagállam illetékes hatóságának jelezni kell bármilyen

olyan súlyos balesetet, amely az általunk szállíto

orvostechnikai eszközzel kapcsolatban történt

FIGYELMEZTETÉS: Всички сериозни инциденти,

които са настъпили във връзка с доставеното

от нас медицинско изделие, трябва да

се сигнализират на производителя и на

компетентния орган на държавата членка, в

която производителят е установен.

WAARSCHUWING: Alle ernsge ongelukken die zich

in verband met het door ons geleverde medische

hulpmiddel voordoen, moeten gemeld worden aan de

fabrikant en aan de bevoegde instane van de lidstaat

waar u gevesgd bent

Use and maintenance book

Manual de ulizare și întreținere

Instrukoner för användning och underhåll

Käyö- ja huolto-ohjeet

Priručnik za uporabu i održavanje

Kezelési és karbantartási útmutató

Инструкции за употреба и поддръжка

Instruces voor gebruik en onderhoud

Medicare AG, Hauptstr. 51

5024 Küttigen, Schweiz

CHRN-AR-20002506

ENGLISH

INSTRUCTIONS TO USER

Read these instrucons carefully before using this equipment. These in-

strucons describe the operang procedures to be followed strictly. Failure to

follow these instrucons can cause measuring abnormality, equipment damage

and personal injury. The manufacturer is NOT re- sponsible for the safety, relia-

bility and performance issues and any mon- itoring abnormality, personal injury

and equipment damage due to user’s negligence of the operaon instrucons.

The manufacturer’s warranty service does not cover such faults.

- The contents contained in this manual are subject to change without noce.

- The uncomfortable or painful feeling may appear if using the device cease-

lessly, especially for the microcirculaon barrier paents. It is recommended

that the sensor should not be applied to the same nger for over 2 hours- If

any abnormal condion is found, please change the posion of Pulse Oximeter.

- For the individual paents, there should be a more prudent inspecng in the

placing process. The device can not be clipped on the edema and tender ssue.

- The light (the infrared is invisible) emied from the device is harmful to the

eyes, so the user and the maintenance man, can not stare at the light.- The

Pulse Oximeter is not a treatment device.

- Testee can not use enamel or other makeup on the nge.

- Testee’s ngernail can not be too long- Please peruse the relave con- tent

about the clinical restricons and cauon.

1. SAFETY

1.1 Instrucons for Safe Operaons

- Check the main unit and all accessories periodically to make sure that there is

no visible damage that may aectpaent’s safety and monitoring performance

with regard to sensors and clips. It is recom- mended that the device should

be inspected minimally before each use. When there is obvious damage, stop

using the oximeter.

- Necessary maintenance must be performed by qualid service tech- nicians

ONLY. Users are not permied to maintain it by themselves.

- The oximeter cannot be used together with the devices and accesso- ries not

specied in Use’s Manual.

- Special aenon should be paid while the Pulse Oximeter is used constantly

when the ambient temperature over 37°C, burning hurt may occur because of

over-heang of the sensor at this situaon.

1.2 Aenons

3ENGLISH

- Keep the oximeter away from dust, vibraon, corrosive sub- stances,

explosive materials, high temperature and moisture.

– The device should be kept out of the reach of children.

- If the oximeter gets wet, please stop using it and do not resume oper- aon

unl it is dry and checked for correct operaon. When it is car- ried from cold

environment to warm and humid environment, please do not use it immedia-

tely. Allow at least 15 minutes for Pulse Oximeter to reach ambient tempe-

rature.

- DO NOT press the keys on front panel with sharp materials or sharp points.

- High temperature or high pressure steam disinfecon to the oximeter is not

permied. Refer to User’s Manual for instrucons of cleaning and disinfecon.

- The nger should be put in properly and correctly.

- Do not shake the nger. Keep at ease during measurement.

- Do not put wet nger directly into sensor.

- Do not let anything block the eming light from the device.

- Ensure that there is artery vessel within measuring site where the light tran-

smits through.

- Vigorous exercise and the interference from the electrosurgical device may

aect the measuring accuracy.

- If the rst reading appears with poor waveform (irregular or not smooth), then

the reading is unlikely true, the more stable value is ex- pected by waing for a

while, or a restart is needed when necessary.

2. OVERVIEW

SpO2 is the saturaon percentage of oxygen in the blood, so called O2 concen-

traon in the blood; it is dened by the percentage of oxyhemo-globin (HbO2)

in the total hemoglobin of the arterial blood. SpO2 is an important physiological

parameter to reect the respiraon funcon; it is calculated by the following

method:

SpO2 = HbO2/ (HbO2 +Hb)×100%

HbO2 are the oxyhemoglobins (oxygenized hemoglobin), Hb are those hemo-

globins which release oxygen.

2.1 Features

- Large true color OLED display of SpO2 , PR Pulse Bar, PI & Plethys- mogram.

- Innovave 4 direcons display.

- Automac power on/o.

- Audible & visible over-limit indicaon.

- Shi parameter display between PR and PI.

ENGLISH

2AAA alkaline baeries with low power consumpon.

- Low baery voltage indicaon. Lanyard Hole

Display

Battery Cover

Lock button of

battery cover

Nameplate

Display Key

Rubber Cushion

Figure 1

2.2 Major Applicaons and Scope

The Fingerp Oximeter is compact, convenient to use and carry and with low

power consumpon. You just need to put the ngerp into the sensor of the

device, the SpO2 value will appear on the screen imme- diately.

The Fingerp Oximeter can detect SpO2 and pulse rate through pa- ent’s nger.

This device is applicable to home, hospital (including internal medicine, surgery,

anesthesia, pediatrics, emergency room etc.), oxygen bar, the community medi-

cal center, alpine area and it also can be used before or aer sports, and the like.

This device is not appropriate to be used for connuous mon- itoring.

2.3 Principle of Measurement

Based on Lamber-Beer law, the light absorbance of a given substance is directly

proporonal with its density or concentraon. When the light with certain wa-

velength emits on human ssue, the measured intensity of light aer absorp-

on, reecng and aenuaon in ssue can reect the structure character of

the ssue by which the light passes. Due to that oxygenated hemoglobin (HbO2)

and deoxygenated hemoglobin (Hb) have dierent absorpon character in the

spectrum range from red to infrared light (600nm~1000nm wavelength), by

using these character- iscs, SpO2 can be determined. SpO2 measured by this

Pulse Oximeter is the funconal oxygen saturaon -- a percentage of the he-

moglobin that can transport oxygen. In contrast, hemoximeters report fraco-

5ENGLISH

nal oxygen saturaon – a percentage of all measured hemoglobin, including

dysfunconal hemoglobin, such as carboxyhemoglobin or metahemo- globin.

Clinical applicaon of pulse oximeters: SpO2 is an important phys- iological

parameter to reect the respiraon and venlaon funcon, so SpO2 moni-

toring used in treatment has become more popular. (For example, such as mo-

nitoring paents with serious respiratory disease, paents under anesthesia

during operaon and premature and neo- natal infants) The status of SpO2

can be determined in mely manner by measurement and will allow nding

the hypoxemia paent earlier, thereby prevenng or reducing accidental death

caused by hypoxia eecvely.

Factors aecng SpO2 measuring accuracy (interference reason)

- Intravascular dyes such as indocyanine green or methylene blue.

- Exposure to excessive illuminaon, such as surgical lamps, bilirubin lamps,

uorescent lights, infrared heang lamps, or direct sunlight.

- Vascular dyes or external used color-up product such as nail enamel or color

skin care.

- Excessive paent movement.

- Placement of a sensor on an extremity with a blood pressure cu, arterial

catheter, or intravascular line.

- Exposure to the chamber with High pressure oxygen.

- There is an arterial occlusion proximal to the sensor.

- Blood vessel contracon caused by peripheral vessel hyperkinesias or body

temperature decreasing.

Factors causing low SpO2 Measuring value (pathology reason)

- Hypoxemia disease, funconal lack of HbO2.

- Pigmentaon or abnormal oxyhemoglobin level.

- Abnormal oxyhemoglobin variaon.

- Methemoglobin disease.

- Sulemoglobinemia or arterial occlusion exists near sensor.

- Obvious venous pulsaons.

- Peripheral arterial pulsaon becomes weak.

- Peripheral blood supply is not enough.

2.4 Cauon

A. The nger should be placed properly (see the gure 3 of this manual), or else

it may cause inaccurate measurement.

ENGLISH

B. The SpO2 sensor and photoelectric receiving tube should be ar- ranged in a

way with the subject’s arteriole in a posion there be- tween.

C. The SpO2 sensor should not be used at a locaon or limb ed with arterial

canal or blood pressure cu or receiving intravenous injec- on.

D. Do not x the SpO2 sensor with adhesive or else it may result in venous

pulsaon and inaccurate measure of SpO2.

E. Make sure the opcal path is free from any opcal obstacles like

rubberized fabric.

F. Excessive ambient light may aect the measuring result. It includes uore-

scent lamp, dual ruby light, infrared heater, direct sunlight and etc.

G. Strenuous acon of the subject or extreme electrosurgical interfer- ence may

also aect the accuracy.

3. BATTERY INSTALLATION

1. Press the lock buon of the baery cover, meanwhile, pull the cover back

and take it out.

2. Refer to Figure 2, insert two AAA size baeries into the baery com- part-

ment properly.

3. Replace the cover. Please make sure that the baeries are correctly installed

since the incorrect installaon may cause the device inoper- able.

Figure 2

Baery Installaon

4. OPERATION

4.1 Start Measurement

1. Open the clip as shown in Figure 3.

7ENGLISH

2. Put nger into the rubber cushions of the clip (make sure the nger is in the

correct posion), and then clip the nger.

3. The device will power on automacally in 2 seconds, and start to dis- play

soware version number.

4. Next enter into data display screen (as shown in Figure 4). The user can read

the values and view the waveform from display screen.

Figure 3 Put nger into the Oximeter

Figure 4 A1 Figure 4 A2 Figure 4 A2 Figure 4 A2

Figure 4 C1 Figure 4 C2 Figure 4 D1 Figure 4 D2

ENGLISH

Screen Descripon:

“%SpO2”: The tle of SpO2; “99”: SpO2 value, unit:%;

“PR”: The tle of Pulse Rate; “65”: Pulse Rate value, unit: bpm (beat per mi-

nute);

“”: Pulse beat icon; “

”: Pulse bar-graph;

“PI%”: The tle of Perfusion Index; “1.4”: Perfusion Index value, unit: %;

“”: Baery power indicator.

5. Change display direcon

Four direcons display alternately. Short me press “Display Key” to ip the

screen 90° each me in a cyclical manner as shown in Figure

4. When the screen displays towards the le side, the plethysmogram will be

viewed.

6. Shi parameter display between PR and PI during measurement Long me

press the “Display Key”, shi the parameter display between PR and PI. But

when the PR is shied to PI display and no buon oper- aon is performed aer

20 seconds, the PI will change to PR display automacally.

4.2 Over-limit indicaon and Beep Silence

When measuring, if SpO2 value or pulse rate value exceeds the limit, the device

will beep automacally and the value which exceeds its limit will ash on the

screen (Refer to chapter 4 for the detailed informaon). When the beep sound

is acvated by over-limit, it will become silent or d-acve at the following si-

tuaons:

1. The SpO2 and PR value return to normal range.

2. Press Display Key to mute. If this over-limit event persists, the Pulse Oximeter

will resume beeping automacally later in 2 minutes.

3. Remove the nger from the Pulse Oximeter or SpO2 probe.

5. TECHNICAL SPECIFICATIONS

A. SpO2 measurement:

dual-wavelength LED sensor with wavelength:

Red light: 663 nm, Infrared light: 890 nm. Maximal average opcal output

power: ≤1.5mW Measuring range: 35%~100%

Measuring accuracy:

≤ 3% for SpO2 range from 70% to 100% SpO2 low over-limit: 90%

B. Pulse Rate measurement:

Measuring range: 30bpm~240bpm

Measuring accuracy: ±2bpm or ±2% (whichever is greater)

Pulse Rate over-limit: high over-limit: 120bpm; low over-limit: 50bpm

9ENGLISH

C. Perfusion Index (PI) Display

Range: 0.2%~20%

D. Audible & visual over-limit indicaon

When measuring, if SpO2 value or pulse rate value exceeds the limit, the device

will beep automacally and the value which exceeds its limit will ash on the

screen. The Oximeter will shut down automa- cally in 8 seconds with no signal.

E. Display: Color OLED Display

F. Power supply requirement:

2 x LR03 (AAA) alkaline baeries Working voltage: 2.2V~3.3VDC Operang cur-

rent: ≤40mA

G. Environment requirement Operang Temperature: 5 ~40°C Operang Humi-

dity: 30~80% Atmospheric pressure: 70~106kPa

H. The performance under low perfusion condion

The accuracy of SpO2 and PR measurement sll meets the specica- on de-

scribed above when the pulse modulaon amplitude is as low as 0.6%.

I. Resistance to ambient light interference:

The accuracy of SpO2 and PR measurement sll meets the speci- caon de-

scribed above when the device is tested by SpO2 simulator (Fluke Biomedi-

cal Index 2 series) while seng the emulang interfer- ence of sun light and

50Hz/60Hz uorescent light.

J. Dimensions: 60 mm (L) × 33 mm (W) × 30 mm (H)

Net Weight: 35g (including baery)

K. Classicaon:

The type of protecon against electric shock: Internally powered equipment.

The degree of protecon against electric shock: Type BF applied parts.

The degree of protecon against harmful ingress of liquids: Ordinary equip-

ment without protecon against ingress of water.

Electro-Magnec Compability: Group I, Class B.

6. ACCESSORIES

A. A lanyard

B. Two baeries

C. A carrying pouch

D. A User Manual

Note: The accessories are subject to change. Detailed items and quanty

see the Packing List.

7. REPAIR AND MAINTENANCE

The expected service life (not a warranty) of this device is 5 years. In order to

ENGLISH

ensure its long service life, please pay aenon to the use of maintenance.

A. Please change the baeries when the low-voltage indicator lightens.

B. Please clean the surface of the device before using. Wipe the device with

75% alcohol wipes, and then let it dry in air or wipe it dry. Do not allow liquid

to enter the device.

C. Please take out the baeries if the oximeter will not be used for for any

more than 7 days.

D. The recommended storage environment of the device is -20ºC to 60ºC am-

bient temperature and 10% to 95% relave humidity with atmospheric pres-

sure: 50kPa~107.4kPa.

E. The Pulse Oximeter is calibrated in the factory before sale, so there is no

need to calibrate it during its life cycle. However, if it is necessary to verify its

precision rounely, the user can do the vericaon by means of SpO2 simula-

tor, or it can be done by the local third party tesng house.

7.1 Cleaning and Disinfecng Instrucon

Surface-clean sensor with a so cloth damped with a soluon such as 75% iso-

propyl alcohol, if low-level disinfecon is required, use a mild bleach soluon.

Then surface-clean by so cloth damped ONLY with clean water and let air dry

or wipe it dry.

Cauon: Do not sterilize by irradiaon steam, or ethylene oxide. Do not use the

Pulse Oximeter if it is damaged visually

High-pressure sterilizaon 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 en- vironment

8. TROUBLESHOOTING

Trouble Possible Reason Soluon

The SpO2

and Pulse Rate

display instable

1. The nger is not placed

far enough inside.

2. The nger is shaking or

the paent is moving.

1. Place the nger correctly

inside and try again.

2. Let the paent keep

calm

Cannot turn on

the device

1. The baeries are drained or almost

drained.

2. The baeries are not inserted

properly.

3 . The device is malfunconing.

1. Change baeries.

2. Reinstall baeries.

3. Please contact the local

service center

11 ENGLISH

No display

1. The device will power o automacal-

ly when it gets no signal for 8 s.

2. The baeries are almost drained

1. Normal.

2. Change baeries.

Declaraon of Conformity:

The manufacturer hereby declares that this device complies with the following

standards:

IEC 60601-1 IEC60601-1-2

IEC60601-1-11, ISO 80601-2-61 and follows the provisions of the coun- cil di-

recve MDD93/42/EEC.

9. KEY OF SYMBOLS

Symbol Descripon Symbol Descripon

Type BF applied part WEEE disposal

Cauon: read instrucons

(warnings) carefully Keep away from sunlight

Follow instrucons for use Keep in a cool,

dry place

%SpO2 Oxygen saturaon (percentage) Medical Device complies with

Direcve 93/42/EEC

PR Pulse rate

(beats per minute) Product code

Pulse beat icon Lot number

Low baery voltage Manufacturer

Serial number Date of manufacture

CONDIZIONI DI GARANZIA GIMA

Si applica la garanzia B2B standard Gima di 12 mesi.

Smalmento: Il prodoo non deve essere smalto assieme agli altri riu domes-

ci. Gli uten devono provvedere allo smalmento delle apparecchiature da roa-

mare portandole al luogo di raccolta indicato per il riciclaggio delle apparecchiatu-

re eleriche ed eleroniche.

ENGLISH

INFORMATION ON ELECTROMAGNETIC COMPATIBILITY

Electromagnetic compatibility

Levels of compliance with the EN 60601-1-2:2015 standard

- ESD immunity 15kV in air and 8kV on contact (EN 61000-4-2)

- Burst immunity 2kV/100kHz (EN 61000-4-4)

- Surge immunity (EN 61000-4-5): 1kV common/2kV dierential

- Magnetic eld (EN 61000-4-8): 30A/m

- Immunity to rf currents in the range 150kHz-80MHz (EN 61000-4-6) 3V

modulation 80% 1kHz

6V modulation 80% 1kHz for the following frequency ranges:

6.765 MHz ÷ 6.795 MHz

13.553 MHz ÷13.567 MHz

26.957 MHz ÷ 27.283 MHz

40.66 MHz ÷ 40.70 MHz

- CISPR emissions 11 class B

- EN 61000-3-2 class A Harmonic currents

- PST, DT, DC Flickers

Immunity to RF elds (EN 61000-4-3):

Field (V/m) Frequency Modulation

380MHz - 2700MHz 1kHz AM 80%

27 380MHz - 390MHz 18Hz PM 50%

28 430MHz - 470MHz 18Hz PM 50%

9 704MHz - 787MHz 217Hz PM 50%

28 800MHz - 960MHz 18Hz PM 50%

28 1700MHz - 1990MHz 217Hz PM 50%

28 2400MHz - 2570MHz 217Hz PM 50%

9 5100MHz - 5800MHz 217Hz PM 50%

Warnings:

Even if it complies with EN 60601-1-2, the medical device may interfere with other

devices in the vicinity. The device should not be used next to or stacked with other

equipment. Install the device away from other equipment which radiates high

frequencies (short waves, microwaves, electrosurgical units, mobile phones).

The device is designed to operate in an electromagnetic environment in which RF

13 ENGLISH

radiated disturbances are under control. The customer or the operator can help

prevent electromagnetic interference by ensuring a minimum distance between

mobile and portable RF communication devices (transmitters) and the medical

device, as recommended below, in relation to the maximum output power of the

radio communication devices

Rated maximum

output power

of transmitter

(W)

Distance (m) of separation according to the frequency

of the transmitter

from 150kHz to

80MHz

d = 1.2 √P

from 80MHz to

800MHz

d = 1.2 √P

from 800MHz to

2.5GHz

d = 2.3 √P

0,01 0,12 0,12 0,23

0,1 0,38 0,38 0,73

1 1,2 1,2 2,3

10 3,8 3,8 7,3

100 12 12 23

For transmitters whose rated maximum output power is not listed above, the

recommended separation distance d in metres (m) can be calculated using

the equation applicable to the transmitter frequency, where P is the rated

maximum power transmitter output in Watts (W) according to the transmitter

manufacturer.

Notes:

(1) The highest frequency range must be applied at 80 MHz and 800 MHz

(2) These guidelines may not apply to all situations. Electromagnetic propa-

gation is aected by absorption and by the reection from structures, objects

and people.

Gima 35093 Manualul proprietarului

Marca: Gima

Model: 35093

Tip: Manualul proprietarului

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