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
dispozivul medical fabricat de rma noastră, trebuie
semnalat producătorului și autorității competente în sta-
tul membru pe teritoriul căruia își are sediul ulizatorul.
OBS: Det är nödvändigt a meddela llverkaren och de
behöriga myndigheterna i den berörda medlemsstaten,
om alla allvarliga olyckor som inträat i samband med
den medicintekniska utrustning som levererats av oss.
VAROITUS: Kaikista vakavista tapaturmista, jotka
liiyvät toimiamamme lääkinnällisen laieen käyöön,
on ilmoiteava 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 ernsge ongelukken die zich
in verband met het door ons geleverde medische
hulpmiddel voordoen, moeten gemeld worden aan de
fabrikant en aan de bevoegde instane van de lidstaat
waar u gevesgd bent
Use and maintenance book
Manual de ulizare și întreținere
Instrukoner för användning och underhåll
Käyö- ja huolto-ohjeet
Priručnik za uporabu i održavanje
Kezelési és karbantartási útmutató
Инструкции за употреба и поддръжка
Instruces voor gebruik en onderhoud
Medicare AG, Hauptstr. 51
5024 Küttigen, Schweiz
CHRN-AR-20002506
2
ENGLISH
INSTRUCTIONS TO USER
Read these instrucons carefully before using this equipment. These in-
strucons describe the operang procedures to be followed strictly. Failure to
follow these instrucons 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 operaon instrucons.
The manufacturer’s warranty service does not cover such faults.
- The contents contained in this manual are subject to change without noce.
- The uncomfortable or painful feeling may appear if using the device cease-
lessly, especially for the microcirculaon barrier paents. It is recommended
that the sensor should not be applied to the same nger for over 2 hours- If
any abnormal condion is found, please change the posion of Pulse Oximeter.
- For the individual paents, there should be a more prudent inspecng in the
placing process. The device can not be clipped on the edema and tender ssue.
- The light (the infrared is invisible) emied 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 relave con- tent
about the clinical restricons and cauon.
1. SAFETY
1.1 Instrucons for Safe Operaons
- Check the main unit and all accessories periodically to make sure that there is
no visible damage that may aectpaent’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 qualid service tech- nicians
ONLY. Users are not permied to maintain it by themselves.
- The oximeter cannot be used together with the devices and accesso- ries not
specied in Use’s Manual.
- Special aenon should be paid while the Pulse Oximeter is used constantly
when the ambient temperature over 37°C, burning hurt may occur because of
over-heang of the sensor at this situaon.
1.2 Aenons
3ENGLISH
- Keep the oximeter away from dust, vibraon, 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- aon
unl it is dry and checked for correct operaon. 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 disinfecon to the oximeter is not
permied. Refer to User’s Manual for instrucons of cleaning and disinfecon.
- 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 eming 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
aect 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 waing for a
while, or a restart is needed when necessary.
2. OVERVIEW
SpO2 is the saturaon percentage of oxygen in the blood, so called O2 concen-
traon in the blood; it is dened by the percentage of oxyhemo-globin (HbO2)
in the total hemoglobin of the arterial blood. SpO2 is an important physiological
parameter to reect the respiraon funcon; 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.
- Innovave 4 direcons display.
- Automac power on/o.
- Audible & visible over-limit indicaon.
- Shi parameter display between PR and PI.
4
ENGLISH
2AAA alkaline baeries with low power consumpon.
- Low baery voltage indicaon. Lanyard Hole
Display
Battery Cover
Lock button of
battery cover
Nameplate
Display Key
Rubber Cushion
Figure 1
2.2 Major Applicaons and Scope
The Fingerp Oximeter is compact, convenient to use and carry and with low
power consumpon. You just need to put the ngerp into the sensor of the
device, the SpO2 value will appear on the screen imme- diately.
The Fingerp 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 aer sports, and the like.
This device is not appropriate to be used for connuous mon- itoring.
2.3 Principle of Measurement
Based on Lamber-Beer law, the light absorbance of a given substance is directly
proporonal with its density or concentraon. When the light with certain wa-
velength emits on human ssue, the measured intensity of light aer absorp-
on, reecng and aenuaon in ssue can reect the structure character of
the ssue by which the light passes. Due to that oxygenated hemoglobin (HbO2)
and deoxygenated hemoglobin (Hb) have dierent absorpon character in the
spectrum range from red to infrared light (600nm~1000nm wavelength), by
using these character- iscs, SpO2 can be determined. SpO2 measured by this
Pulse Oximeter is the funconal oxygen saturaon -- a percentage of the he-
moglobin that can transport oxygen. In contrast, hemoximeters report fraco-
5ENGLISH
nal oxygen saturaon – a percentage of all measured hemoglobin, including
dysfunconal hemoglobin, such as carboxyhemoglobin or metahemo- globin.
Clinical applicaon of pulse oximeters: SpO2 is an important phys- iological
parameter to reect the respiraon and venlaon funcon, so SpO2 moni-
toring used in treatment has become more popular. (For example, such as mo-
nitoring paents with serious respiratory disease, paents under anesthesia
during operaon and premature and neo- natal infants) The status of SpO2
can be determined in mely manner by measurement and will allow nding
the hypoxemia paent earlier, thereby prevenng or reducing accidental death
caused by hypoxia eecvely.
Factors aecng SpO2 measuring accuracy (interference reason)
- Intravascular dyes such as indocyanine green or methylene blue.
- Exposure to excessive illuminaon, such as surgical lamps, bilirubin lamps,
uorescent lights, infrared heang lamps, or direct sunlight.
- Vascular dyes or external used color-up product such as nail enamel or color
skin care.
- Excessive paent 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 contracon caused by peripheral vessel hyperkinesias or body
temperature decreasing.
Factors causing low SpO2 Measuring value (pathology reason)
- Hypoxemia disease, funconal lack of HbO2.
- Pigmentaon or abnormal oxyhemoglobin level.
- Abnormal oxyhemoglobin variaon.
- Methemoglobin disease.
- Sulemoglobinemia or arterial occlusion exists near sensor.
- Obvious venous pulsaons.
- Peripheral arterial pulsaon becomes weak.
- Peripheral blood supply is not enough.
2.4 Cauon
A. The nger should be placed properly (see the gure 3 of this manual), or else
it may cause inaccurate measurement.
6
ENGLISH
B. The SpO2 sensor and photoelectric receiving tube should be ar- ranged in a
way with the subject’s arteriole in a posion there be- tween.
C. The SpO2 sensor should not be used at a locaon 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
pulsaon and inaccurate measure of SpO2.
E. Make sure the opcal path is free from any opcal obstacles like
rubberized fabric.
F. Excessive ambient light may aect the measuring result. It includes uore-
scent lamp, dual ruby light, infrared heater, direct sunlight and etc.
G. Strenuous acon of the subject or extreme electrosurgical interfer- ence may
also aect the accuracy.
3. BATTERY INSTALLATION
1. Press the lock buon of the baery cover, meanwhile, pull the cover back
and take it out.
2. Refer to Figure 2, insert two AAA size baeries into the baery com- part-
ment properly.
3. Replace the cover. Please make sure that the baeries are correctly installed
since the incorrect installaon may cause the device inoper- able.
Figure 2
Baery Installaon
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 posion), and then clip the nger.
3. The device will power on automacally in 2 seconds, and start to dis- play
soware 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
8
ENGLISH
Screen Descripon:
“%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: %;
“”: Baery power indicator.
5. Change display direcon
Four direcons 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 shied to PI display and no buon oper- aon is performed aer
20 seconds, the PI will change to PR display automacally.
4.2 Over-limit indicaon and Beep Silence
When measuring, if SpO2 value or pulse rate value exceeds the limit, the device
will beep automacally and the value which exceeds its limit will ash on the
screen (Refer to chapter 4 for the detailed informaon). When the beep sound
is acvated by over-limit, it will become silent or d-acve at the following si-
tuaons:
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 automacally 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 opcal 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 indicaon
When measuring, if SpO2 value or pulse rate value exceeds the limit, the device
will beep automacally 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 baeries Working voltage: 2.2V~3.3VDC Operang cur-
rent: ≤40mA
G. Environment requirement Operang Temperature: 5 ~40°C Operang Humi-
dity: 30~80% Atmospheric pressure: 70~106kPa
H. The performance under low perfusion condion
The accuracy of SpO2 and PR measurement sll meets the specica- on de-
scribed above when the pulse modulaon amplitude is as low as 0.6%.
I. Resistance to ambient light interference:
The accuracy of SpO2 and PR measurement sll meets the speci- caon de-
scribed above when the device is tested by SpO2 simulator (Fluke Biomedi-
cal Index 2 series) while seng the emulang 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 baery)
K. Classicaon:
The type of protecon against electric shock: Internally powered equipment.
The degree of protecon against electric shock: Type BF applied parts.
The degree of protecon against harmful ingress of liquids: Ordinary equip-
ment without protecon against ingress of water.
Electro-Magnec Compability: Group I, Class B.
6. ACCESSORIES
A. A lanyard
B. Two baeries
C. A carrying pouch
D. A User Manual
Note: The accessories are subject to change. Detailed items and quanty
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
ENGLISH
ensure its long service life, please pay aenon to the use of maintenance.
A. Please change the baeries 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 baeries 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% relave 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 rounely, the user can do the vericaon by means of SpO2 simula-
tor, or it can be done by the local third party tesng house.
7.1 Cleaning and Disinfecng Instrucon
Surface-clean sensor with a so cloth damped with a soluon such as 75% iso-
propyl alcohol, if low-level disinfecon is required, use a mild bleach soluon.
Then surface-clean by so cloth damped ONLY with clean water and let air dry
or wipe it dry.
Cauon: Do not sterilize by irradiaon steam, or ethylene oxide. Do not use the
Pulse Oximeter if it is damaged visually
High-pressure sterilizaon 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 Soluon
The SpO2
and Pulse Rate
display instable
1. The nger is not placed
far enough inside.
2. The nger is shaking or
the paent is moving.
1. Place the nger correctly
inside and try again.
2. Let the paent keep
calm
Cannot turn on
the device
1. The baeries are drained or almost
drained.
2. The baeries are not inserted
properly.
3 . The device is malfunconing.
1. Change baeries.
2. Reinstall baeries.
3. Please contact the local
service center
11 ENGLISH
No display
1. The device will power o automacal-
ly when it gets no signal for 8 s.
2. The baeries are almost drained
1. Normal.
2. Change baeries.
Declaraon 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-
recve MDD93/42/EEC.
9. KEY OF SYMBOLS
Symbol Descripon Symbol Descripon
Type BF applied part WEEE disposal
Cauon: read instrucons
(warnings) carefully Keep away from sunlight
Follow instrucons for use Keep in a cool,
dry place
%SpO2 Oxygen saturaon (percentage) Medical Device complies with
Direcve 93/42/EEC
PR Pulse rate
(beats per minute) Product code
Pulse beat icon Lot number
Low baery voltage Manufacturer
Serial number Date of manufacture
CONDIZIONI DI GARANZIA GIMA
Si applica la garanzia B2B standard Gima di 12 mesi.
Smalmento: Il prodoo non deve essere smalto assieme agli altri riu domes-
ci. Gli uten devono provvedere allo smalmento delle apparecchiature da roa-
mare portandole al luogo di raccolta indicato per il riciclaggio delle apparecchiatu-
re eleriche ed eleroniche.
12
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 dierential
- 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 aected by absorption and by the reection from structures, objects
and people.
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în alte limbi
- English: Gima 35093 Owner's manual
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