Gima 35093 Parts list manual

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
[e-mail] - [e-mail]
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

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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

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- 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.

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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.

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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.

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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

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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

10
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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.

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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.