Gima OXY-5 Parts list manual

Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]
www.gimaitaly.com
PULSOXIMETRO OXY-5
OXIMETER OXY-5
OXYMÈTRE DE POULS OXY-5
PULOXIMETER OXY-5
PULSIOXÍMETRO OXY-5
MEDIDOR DE OXI-PULSAÇÕES OXY-5
ΚΟΡΕΣΤΟΜΕΤΡΟ OXY-5
OKSYMETR OXY-5
OXY-5
M34282-M-Rev.6-03.19
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.
ACHTUNG: Diese Anleitung muss vor dem Einsatz des Produkts aufmerksam gelesen und
vollständig verstanden werden.
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.
ΠΡΟΣΟΧΗ: Οι χειριστές αυτού του προϊόντος πρέπει να διαβάσουν και να καταλάβουν
πλήρως τις οδηγίες του εγχειριδίου πριν από την χρήση του.
UWAGA: Użytkownik powinien uważnie zapoznać się z tym podręcznikiem przed jego użyciem.
Manuale d’uso e manutenzione
Use and maintenance book
Instructions de foncionnement et entretien
Betriebs und wartungs anweisungen
Manual de uso y mantenimiento
Manual de uso e manutenção
Εγχειριδιο χρησης και συντηρησης
Podręcznik eksploatacji i konserwacji
Gima S.p.A.
Via Marconi, 1 - 20060
Gessate (MI) - Italy
Made in China
34282 - 34265 0476
PROFESSIONAL MEDICAL PRODUCTS

12
ENGLISH
Instructions to User
Read these instructions carefully before using this equipment. These instruc-
tions describe the operating procedures to be followed strictly. Failure to follow
these instructions can cause measuring abnormity, equipment damage and
personal injury.
The manufacturer is NOT responsible for the safety, reliability and performance
issues and any monitoring abnormality, personal injury and equipment damage
due to user’s negligence of the operation instructions. The manufacturer’s war-
ranty service does not cover such faults.
- The uncomfortable or painful feeling may appear if using the device ceaseless-
ly, especially for the microcirculation barrier patients. It is recommended that
the sensor should not be applied to the same nger for over 2 hours.
- For 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.
- The light (the infrared is invisible) emitted from the device is harmful to the
eyes, so the user and the maintenance man, can not stare at the light.
- Testee’s ngernail can not be too long.
- Please peruse the relative content about the clinical restrictions and caution.
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 perfor-
mance. It is recommended that the device should be inspected once a week
at least. When there is obvious damage, stop using the oximeter.
- 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 the devices not specied in User’s
Manual.
1.2 Warnings
- Explosive hazard—DO NOT use the oximeter in environment with in-
ammable gas such as some ignitable anesthetic agents.
- DO NOT use the oximeter while the testee measured by MRI and CT.
- To dispose the device, the local law must be followed.

13 ENGLISH
1.3 Attentions
- Keep the oximeter away from dust, vibration, corrosive substances, ex-
plosive materials, high temperature and moisture.
- If the oximeter gets wet, please stop operating it. When it is carried from
cold environment to warm and humid environment, please do not use it
immediately.
- DO NOT press the keys on front panel with sharp materials
- High temperature or high pressure steam disinfection to the oximeter is
not permitted. Refer to User’s Manual for instructions of cleaning and
disinfection.
- DO NOT have the oximeter immerged in liquid. When it needs cleaning,
please wipe its surface with disinfect solution by soft material. Do not
spray any liquid on the device directly.
- When cleaning the device with water, the temperature of water should
be lower than 60°C.
2. OVERVIEW
The pulse oxygen saturation is the percentage of HbO2in the total Hb of the
blood, so-called the O2concentration in the blood. It is an important bio-param-
eter to the respiration. Many of the respiration disease will cause hypoxemia,
even endanger the patient’s health. As a result, monitoring the SpO2is indis-
pensable in the clinical rescuing. The traditional method to measure SpO2is
to analyze the sample of the patient’s blood, so can get the partial pressure of
oxygen and calculate the SpO2by use the blood-gas analyzer. This method is
inconvenient and can not be used to monitor continuously. For the purpose of
measuring the SpO2more easily and accurately, Creative developed the Finger-
tip Oximeter. The device can measure the pulse rate simultaneously.
The Fingertip Oximeter is compact, convenient to use and carry and with low
power consumption. You just need to put the ngertip into the sensor of the
device, the SpO2value will appear on the screen immediately.
2.1 Features
- Accurately measure SpO2value and pulse rate value;
- Perfusion index display is available;
- Automatic start measuring after putting nger into rubber cushion;
- Power off automatically without signal for more than 8 seconds;
- Audible & visible alarm function;
- Low voltage indication;

14
2.2 Major Applications and Scope
The Fingertip Oximeter can detect SpO2and pulse rate through patient’s nger,
and indicate the pulse intensity by the bar-display. This device is applicable
to home, hospital (including internal medicine, surgery, anesthesia, pediatrics,
emergency room etc.), oxygen bar, the community medical center, alpine area
and it also can be used before or after sports, and the like.
This device is not appropriate to be used for continuous monitoring.
2.3 Environment Requirements
Temperature:
Operating Temperature: 5°C ~40°C
Storage Temperature: -20°C~60°C
Humidity:
Operating Humidity: 30%~80%
Storage Humidity: 10%~100%
Atmospheric pressure:
Operating Pressure: 70kPa~106kPa
Storage Pressure: 50kPa~106kPa
2.4 Principle of Measurement
The measurement of pulse oximeter is that it uses a multi-functional oxyhe-
moglobinometer to transmit some narrow spectrum light bands through blood
samples and to measure attenuation of spectrum with different wavelengths
according wo the characteristic that RHb, O2Hb, Met Hb and COHb absorb the
light of different wavelength, thereby determining O2Hb saturation of different
fractions. O2Hb saturation is called “fractional” O2Hb saturation.
Fractional O2Hb saturation = [O2Hb / (RHb + O2Hb + Met Hb + COHb)] × 100
Oppositely, pulse oxygen oximeter measures functional O2Hb saturation:
Functional O2Hb saturation = [O2Hb / (RHb + O2Hb)] × 100
Present SpO2oximeter transmits light of two wavelengths only, red light (wave-
length 660 nm) and infrared (wavelength 940 nm), to differentiate HbO2from
HbR. One side of the sensor contains two LEDs, and the other side contains a
photoelectric detector.
SpO2oximeter measures HbO2saturation in the blood by the light plethysmo-
graph when the pulse beats. The result is quite precise when HbO2saturation
is over 70% ~ 95%.
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15
2.5 Caution
A. The nger should be placed properly (see the attached illustration of this
manual), or else it may cause inaccurate measurement.
B. The SpO2sensor and photoelectric receiving tube should be arranged in a
way with the subject’s arteriole in a position there between.
C.The SpO2sensor should not be used at a location or limb tied with arterial
canal or blood pressure cuff or receiving intravenous injection.
D. Do not x the SpO2sensor with adhesive or else it may result in venous
pulsation and inaccurate measure of SpO2.
E. Make sure the optical path is free from any optical obstacles like rubberized
fabric.
F. Excessive ambient light may affect the measuring result. It includes uores-
cent lamp, dual ruby light, infrared heater, direct sunlight and etc.
G.Strenuous action of the subject or extreme electrosurgical interference may
also affect the accuracy.
H.Testee can not use enamel or other makeup on the nger.
3. TECHNICAL SPECIFICATIONS
A. Display mode: LCD Display
B. Power supply requirement:
1.5V (AAA size) alkaline battery × 2
Supply voltage: 3VDC
Operating current: <=15mA (backlight off)
C.SpO2Parameter Specifications
Measuring range: 35%~99%
Accuracy: ±2% (during 75%~99%)
±3% (during 50%~75%)
SpO2alarm:
Lower limit: 90%
D.Pulse Rate Parameter Specifications
Measuring range: 30bpm~240bpm
Accuracy: ±2bpm or ±2% (whichever is greater)
Pulse Rate alarm: Upper limit: 120bpm
Lower limit: 50bpm
E. Blood Perfusion Display
Range: 0~20%
F. Resistance to interference of surrounding light
The difference between the value measured in the condition of indoor natural
light and that of darkroom is less than ±1%.
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16
G.Resistance to interference of man-made light
Values of SpO2and Pulse Rate can be accurately measured by pulse oxygen
simulator.
H. Dimensions
66 mm (L) × 36 mm (W) × 33 mm (H)
Net Weight: 60g (including batteries)
I. Classification
The type of protection against electric shock: Internally powered equipment.
The degree of protection against electric shock: Type BF applied part.
The degree of protection against harmful ingress of liquids: Ordinary equip-
ment without protection against ingress of water.
Electro-Magnetic Compatibility: Group I, Class B
4. ACCESSORIES
A. A hanging cord
B. Two batteries
C. A pouch
D. A User Manual
5. INSTALLATION
5.1 Appearance
Front View Rear View
Hanging
hole
Battery
cover
Nameplate
Display Key
Rubber
cushions
Display
Screen
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17
5.2 Battery
Refer to the gure, and insert the two AAA
size batteries properly in the right direc-
tion. Replace the cover
- Please take care when you insert the
batteries for the improper insertion may
damage the device.
5.3 Mounting the Hanging
Cord
Step 1. Put the end of the cord through
the hole.
Step 2. Put another end of the cord
through the rst one and then tighten it.
6. OPERATING GUIDE
A. Open the clip as shown in gure.
B. Let the patient’s nger put into the rubber cushions of the clip (make sure the
nger is in the right position), and then clip the nger.
C.The device will power on automatically in 2 seconds, and start to measure.
D. Do not shake the nger and keep the patient at ease during the process.
E. Do not put wet nger directly into sensor.
F. Measurement result will be displayed on the screen (as
shown in gure). User can read SpO2and HR values
from display screen.
“%SpO2”: SpO2symbol
“ ”: Pulse rate symbol; “BPM”: the unit of pulse rate
(beats per minute);
“ ”: Pulse intensity histogram.
When the display screen is shown as gure, press Dis-
ENGLISH

18
play Key to turn on the backlight; if no key is pressed,
the backlight will be off automatically in 6 seconds.
G.Longtime press Display Key during monitoring, display
screen will be shown as gure; “PI” indicates perfusion
index.
H.Alarm Indicator
When measuring, if SpO2value or pulse rate value exceeds the preset alarm
limit, the device will alarm automatically and the value which exceeds limit on
the screen will ash (refer to Technical Specications for alarm limits).
7. REPAIR AND MAINTENANCE
A. Please change the batteries when the low-voltage indicator lightens.
B. Please clean the surface of the device before using. Wipe the device with
alcohol rst, and then let it dry in air or wipe it dry.
C.Please take out the batteries if the oximeter will not be used for a long time.
D. The best storage environment of the device is -20ºC to 60ºC ambient temper-
ature and 10% to 95% relative humidity.
The life of this device is 5 years.
High-pressure sterilization 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 environment.
Humidity may reduce the useful life of the device, or even damage it.
Factors affect SpO2measuring accuracy (interference reason)
- Intravascular dyes such as indocyanine green or methylene blue.
- Exposure to excessive illumination, such as surgical lamps, bilirubin lamps,
uorescent lights, infrared heating lamps, or direct sunlight.
- Vascular dyes or external used color-up product such as nail enamel or color
skin care.
- Excessive patient movement.
- Placement of a sensor on an extremity with a blood pressure cuff, arterial
catheter, or intravascular line.
- Exposure to the chamber with High pressure oxygen.
- There is arterial occlusion proximal to the sensor.
- Blood vessel contraction caused by peripheral vessel hyperkinesias or body
temperature decreasing.
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19
Factors caused low SpO2Measuring value (pathology reason)
- Hypoxemia disease, functional lack of HbO2.
- Pigmentation or abnormal oxyhemoglobin level.
- Abnormal oxyhemoglobin variation.
- Methemoglobin disease.
- Sulfhemoglobinemia or arterial occlusion exists near sensor.
- Obvious venous pulsations.
- Peripheral arterial pulsation becomes weak.
- Peripheral blood supply is not enough.
8. TROUBLESHOOTING
Trouble Possible Reason Solution
The SpO2and
Pulse Rate can
not be displayed
normally.
1. The nger is not
properly positioned.
2. The patient’s SpO2is
too low to be detected.
1. Place the nger
properly and try again.
2. Try again; Go to a
hospital for a diagnosis
if you are sure the device
works all right.
The SpO2and
Pulse Rate
display instable.
1. The nger is not
placed inside enough.
2. The nger is shaking
or the patient is moving.
1. Place the nger
properly and try again.
2. Let the patient keep
calm.
The device can
not turn on.
1. The batteries are
drained or almost drained
2. The batteries are not
inserted properly.
3. The device’s
malfunction
1. Change batteries.
2. Reinstall batteries.
3. Please contact the
local service center.
The indicator light
is off suddenly.
1. The device will power
off automatically when
it gets no signal for 8
seconds.
2. The batteries are almost
drained.
1. Normal.
2. Change batteries.
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Symbol Description Symbol Description
Type BF applied part WEEE
Read instructions carefully Keep away from sunlight
Please read instructions
carefully Keep in a cool, dry place
%SpO2 The pulse oxygen
saturation
Product complies with
European Directive
PI Perfusion Index Product code
hpm Pulse rate
(beats per minute)
Lot number
(see box / package)
Low battery voltage Manufacturer
Serial number Date of manufacture
9. KEY OF SYMBOLS
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Disposal: The product must not be disposed of along with other do-
mestic waste. The users must dispose of this equipment by bringing it
to a specific recycling point for electric and electronic equipment. For
further information on recycling points contact the local authorities, the
local recycling center or the shop where the product was purchased.
If the equipment is not disposed of correctly, fines or penalties may
be applied in accordance with the national legislation and regulations.
GIMA WARRANTY CONDITIONS
Congratulations for purchasing a GIMA product. This product meets high quali-
tative standards both as regards the material and the production.
The warranty is valid for 12 months from the date of supply of GIMA.
During the period of validity of the warranty, GIMA will repair and/or replace free
of charge all the defected parts due to production reasons.
Labor costs and personnel traveling expenses and packaging not included.
All components subject to wear are not included in the warranty.
The repair or replacement performed during the warranty period shall not ex-
tend the warranty. The warranty is void in the following cases: repairs performed
by unauthorized personnel or with non-original spare parts, defects caused by
negligence or incorrect use. GIMA cannot be held responsible for malfunction-
ing on electronic devices or software due to outside agents such as: voltage
changes, electro-magnetic elds, radio interferences, etc. The warranty is void
if the above regulations are not observed and if the serial code (if available) has
been removed, cancelled or changed.
The defected products must be returned only to the dealer the product was
purchased from. Products sent to GIMA will be rejected.
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98
Guidance and manufacturer’s declaration-electromagnetic emission
The Fingertip Oximeter is intended for use in the electromagnetic environ-
ment specied below. The customer or the user of the Fingertip Oximeter
should assure that it is used in such an environment.
Emission test Compliance Electromagnetic
environment-guidance
RF emissions
CISPR 11
Group 1 The Fingertip Oximeter uses RF
energy only for its internal func-
tion. Therefore, its RF emissions
are very low and are not likely to
cause any interference in nearby
electronic equipment.
RF emissions
CISPR 11
Class B The Fingertip Oximeter suitable
for use in all establishments,
including domestic establishments
and those directly network that
supplies buildings used for
domestic purposes.
Harmonic emissions
IEC 61000-3-2
N/A
Voltage uctuations/
icker emission
IEC 61000-3-3
N/A
APPENDIX II EMC
The equipment meets the requirements of IEC 60601-1-2:2014.
Table 1

99
Guidance and manufacturer’s declaration-electromagnetic emission
The Fingertip Oximeter is intended for use in the electromagnetic environment
specied below. the customer or the user of the Fingertip Oximeter should
assure that it is used in such an environment.
Immunity test IEC60601
test level
Compliance
level
Electromagnetic
environment-guidance
Electrostatic
discharge
(ESD) IEC
61000-4-2
±6kV contact
±8kV air ±6kV contact
±8kV air
Floors should be wood,
concrete or ceramic tile.
If oor are covered with
synthetic material, the
relative humidity should
be at least 30%.
Electrical fast
transient/
burst
IEC 61000-4-4
±2kV for power
supply lines
±1kV for input /
output lines
N/A N/A
Surge IEC
61000-4-5 ±1kV line (s) to line(s)
±2kV line(s)
to earth
N/A N/A
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
<5% UT
(>95% dip in UT)
for 0.5 cycle
<40% UT
(60% dip in UT)
for 5 cycles
<70% UT
(30% dip in UT)
for 25 cycles
<5% UT (>95%
dip in UT) for 5 s
N/A N/A
Power
frequency
(50/60Hz)
magnetic eld
IEC 61000-4-8
3A/m 3A/m Power frequency
magnetic elds should
be at levels characteris-
tic of a typical location
in a typical commercial
or hospital environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.

100
Guidance and manufacturer’s declaration – electromagnetic immunity
The Fingertip Oximeter is intended for use in the electromagnetic environ-
ment specied below. The customer or the user of The Fingertip Oximeter
should assure that it is used in such an electromagnetic environment.
Immunity
test
IEC60601
test level
Compliance
level
Electromagnetic environment -
guidance
Conducted
RF IEC
61000-4-6
Radiated
RF IEC
61000-4-3
3 Vrms
150 kHz
to 80 MHz
3 V/m
80 MHz to
2.5 GHz
N/A
3 V/m
Portable and mobile RF com-
munications equipment should
be used no closer to any part of
The Fingertip Oximeter, including
cables, than the recommended
separation distance calculated
from the equation applicable to
the frequency of the transmitter.
Recommended separation
distance
80MHz to 800MHz
800MHz to 2.5GHz
Where Pis the maximum output
power rating of the transmitter in
watts (W) according to the trans-
mitter manufacturer and dis the
recommended separation dis-
tance in metres (m).b
Field strengths from xed RF
transmitters, as determined by
an electromagnetic site survey,a
should be less than the com-
pliance level in each frequency
range.b
Interference may occur in the vi-
cinity of equipment marked
with the following
symbol.
d= 1.2 √P
d= 1.2 √P
d= 2.3 √P

101
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reection from structures, objects
and people.
a Field strengths from xed transmitters, such as base stations for radio (cel-
lular / cordless) telephones and land mobile radios, amateur radio, AM and
FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to xed RF trans-
mitters, and electromagnetic site survey should be considered. If the meas-
ured eld strength in the location in which The Fingertip Oximeter is used
exceeds the applicable RF compliance level above, The Fingertip Oximeter
should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or
relocating The Fingertip Oximeter.
b Over the frequency range 150 kHz to 80 MHz, eld strengths should be
less than 3V/m.

102
Recommended separation distances between portable and mobile RF
communication the equipment
The Fingertip Oximeter is intended for use in an electromagnetic environment
in which radiated RF disturbances are controlled. The customer or the user
of The Fingertip Oximeter can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communi-
cations equipment (transmitters) and the Fingertip Oximeter as recommend-
ed below, according to the maximum output power of the communications
equipment.
Rated
maximum
output
power of
transmitter
W (Watts)
Separation distance according to frequency of transmitter
M (Meters
150KHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz
0,01 N/A 0.12 0.23
0,1 N/A 0.38 0.73
1 N/A 1.2 2.3
10 N/A 3.8 7.3
100 N/A 12 23
For transmitters rated at a maximum output power not listed above, the
recommended separation distanced in meters (m) can be estimated using
the equation applicable to the frequency of the transmitter, where Pis the
maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTE 1 At 80MHz and 800MHz, the separation distance for the higher fre-
quency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reection from structures, objects
and people.
d= 1.2 √P d= 1.2 √P d= 2.3 √P

103