Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
PROFESSIONAL MEDICAL PRODUCTS
www.gimaitaly.com
SATURIMETRO OXY-6
OXIMETER OXY-6
OXYMÈTRE OXY-6
PULSOXIMETER OXY-6
SATURÓMETRO OXY-6
MEDIDOR DE SATURAÇÃO OXY-6
KOPEΣTOMETPO
OXY-6
OXY-6
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
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.
M34285-M-Rev.3.03.19
34285
Gima S.p.A.
Via Marconi, 1 - 20060
Gessate (MI) - Italy
Made in China
0476
ENGLISH
Instructions to User
Read these instructions carefully before using this equipment. These
instructions 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 warranty
service does not cover such faults.
- The uncomfortable or painful feeling may appear if using the device
ceaselessly, 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 can not use enamel or other makeup on the nger.
- estee’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 performance. 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 qualied service engineers ONLY. Users are not permitted to maintain it by themselves.
- The oximeter cannot be used together with the devices not specied
in User’s Manual.
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1.2 Warnings
- Explosive hazard—DO NOT use the oximeter in environment.
with inammable 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.
1.3 Attentions
- Keep the oximeter away from dust, vibration, corrosive substances, explosive 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
2. OVERVIEW
The pulse oxygen saturation is the percentage of HbO2 in the total Hb
of the blood, so-called the O2 concentration in the blood. It is an important bio-parameter to the respiration. Many of the respiration disease
will cause hypoxemia, even endanger the patient’s health. As a result,
monitoring the
tional method to measure
blood, so can get the partial pressure of oxygen and calculate the
by use the blood-gas analyzer. This method is inconvenient and can
not be used to monitor continuously. For the purpose of measuring the
SpO2
ter. The device can measure the pulse rate and blood perfusion index
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
SpO2
is indispensable in the clinical rescuing. The tradi-
SpO2
more easily and accurately, GIMA developed the Fingertip Oxime-
ENGLISH
is to analyze the sample of the patient’s
SpO2
SpO2
SpO2
18
, pulse
is an
ENGLISH
sensor of the device, the
diately.
2.1 Features
- Small in size and lightweight.
- Color OLED, various display modes, display directions adjustable.
- The device can accurately measure
perfusion index.
- The device will automatically start measuring after putting nger into
sensor.
- The device will power off automatically without signal for about 8 seconds.
- Audible & visual alarm.
- Low voltage indication.
2.2 Major Applications and Scope
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. The Fingertip Oximeter can detect
rate and blood perfusion index.
This device is not appropriate to be used for continuous monitoring.
2.3 Environment Requirements
Operating Temperature: 5°C ~40°C
Operating Humidity: 30%~80%
Atmospheric pressure: 70kPa~106kPa
2.4 SpO2 Common Knowledge
1. Meaning of SpO2
SpO2
is the saturation percentage of oxygen in the blood, so called O2
concentration in the blood; it is dened by the percentage of oxyhemoglobin (HbO2) in the total hemoglobin of the arterial blood.
important physiological parameter to reect the respiration function; it is
SpO2
value will appear on the screen imme-
SpO2
value, pulse rate value and
19
calculated by the following method:
SpO2
= HbO2/ (HbO2 +Hb)×100%
HbO2 are the oxyhemoglobins (oxygenized hemoglobin), Hb are those
hemoglobins which release oxygen.
2. Principle of Measurement
Based on Lamber-Beer law, the light absorbance of a given substance
is directly proportional with its density or concentration. When the light
with certain wavelength emits on human tissue, the measured intensity
of light after absorption, reecting and attenuation in tissue can reect
the structure character of the tissue by which the light passes. Due to
that oxygenated hemoglobin (HbO2) and deoxygenated hemoglobin
(Hb) have different absorption character in the spectrum range from red
to infrared light (600nm~1000nm wavelength), by using these characteristics,
SpO2
the functional oxygen saturation - a percentage of the hemoglobin that
can transport oxygen.
In contrast, hemoximeters report fractional oxygen saturation - a percentage of all measured hemoglobin, including dysfunctional hemoglobin, such as carboxyhemoglobin or metahemoglobin.
Clinical application of pulse oximeters:
cal parameter to reect the respiration and ventilation function, so
monitoring used in treatment has become more popular. (For example,
such as monitoring patients with serious respiratory disease, patients
under anesthesia during operation and premature and neonatal infants)
The status of
ment and will allow nding the hypoxemia patient earlier, thereby preventing or reducing accidental death caused by hypoxia effectively.
3. Factors affecting SpO2 measuring 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,
can be determined.
SpO2
can be determined in timely manner by measure-
ENGLISH
SpO2
measured by this oximeter is
SpO2
is an important physiologi-
SpO2
ENGLISH
arterial catheter, or intravascular line.
• Exposure to the chamber with High pressure oxygen.
• There is an arterial occlusion proximal to the sensor.
• Blood vessel contraction caused by peripheral vessel hyperkinesias
or body temperature decreasing.
4. Factors causing low SpO2 Measuring 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.
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
SpO2
sensor and photoelectric receiving tube should be arranged in a way with the subject’s arteriole in a position there between.
C. The
SpO2
sensor 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
nous pulsation and inaccurate measure of
E. Make sure the optical path is free from any optical obstacles like rub-
berized fabric.
F. Excessive ambient light may affect the measuring result. It includes
uorescent lamp, dual ruby light, infrared heater, direct sunlight and
etc.
G. Strenuous action of the subject or extreme electrosurgical interfer-
ence may also affect the accuracy.
H. Testee can not use enamel or other makeup on the nger.
SpO2
sensor with adhesive or else it may result in ve-
SpO2
.
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3. TECHNICAL SPECIFICATIONS
A. Display mode: OLED Display
B. Power supply requirement:
1.5V (AAA size) alkaline battery x 2
Battery voltage: 3VDC
C. Operating current: <50mA
D. SpO2 Parameter Specifications:
Measuring range: 35%~100%
Accuracy: ≤3% (during 70% - 100%)
E. Pulse Rate Parameter Specifications:
Measuring range: 30bpm - 240bpm
Accuracy: ±2bpm or ±2% (which ever is greater)
Pulse Rate alarm: Upper limit: 120bpm
Lower limit: 50bpm
F. Blood Perfusion Parameter Specifications:
Measuring range: 0%~20%
G. The performance under low perfusion condition
The accuracy of
tion described above when the modulation amplitude is as low as 0.6%.
H. Resistance to ambient light interference:
The accuracy of
cation described above when the device is tested by
(Fluke Biomedical Index 2 series) while setting the emulating interference of sun light and 50Hz/60Hz uorescent light.
I. Dimensions: 66 mm (L) x 36 mm (W) x 33 mm (H)
Net Weight: 60g (including batteries)
J. Classification:
The type of protection against electric shock: Internally powered
equipment.
The degree of protection against electric shock: Type BF equipment.
The degree of protection against harmful ingress of water: Ordinary
equipment without protection against ingress of water.
Electro-Magnetic Compatibility: Group I, Class B
SpO2
and PR measurement still meets the specica-
SpO2
and PR measurement still meets the speci-
ENGLISH
SpO2
simulator
ENGLISH
4. ACCESSORIES
A. A hanging cord
B. Two batteries
C. A pouch
D. A User Manual
5. INSTALLATION
5.1. Front view 5.2. Rear view
Rubber
cushion
Operation
key
22
Nameplate
Battery lid
Display
Figure 1 Figure 2
5.3. Battery
Refer to the gure, and insert the
two AAA size batteries properly
in the right direction.
Replace the cover.
- Please take care when you
insert the batteries for the improper insertion may damage
the device.
Hanging
hole
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6. OPERATION
1. Open the clip as shown in Figure 3.
ENGLISH
Figure 3 Put Finger into the Oximeter
2. Put nger into the rubber cushions of the clip (make sure the nger is
in the right position), and then clip the nger.
3. The device will power on automatically in 2 seconds, and start to display software version number.
4. Next enter into data display screen (as shown in Figure 4). User can
read the values and view the waveform from display screen.
“%SpO2”:
“PR”: Pulse rate icon; “65”: Pulse rate value;
“ ”: Pulse beat symbol;
“ ”:Pulse intensity histogram
SpO2
symbol; “99”:
SpO2
value;
Figure 4
5. When the display is shown as Figure 4, press Display Key to switch
display screen:
• Press Display Key once, display screen (as shown in Figure 4) will
be ipped 180°.
• Press Display Key twice, display screen will be changed as Figure 5.
ENGLISH
• Press Display Key three times, display screen (as shown in Figure 5)
will be ipped 180°.
• Press Display Key four times, display screen will back to the screen
as shown in Figure 4.
• Press Display Key circularly, display screen will be switched be-
tween the two screens (as shown in Figure 4 and Figure 5), and four
directions display alternately.
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Figure 5
6. Longtime press Display Key (about 2 seconds), display screen will be
shown as Figure 6. Differences between Figure 6 and Figure 4 are as
follows:
• In Figure 4,
• In Figure 6,
SpO2
on the screen.
played on the screen.
and pulse rate are being monitored and displayed
SpO2
and perfusion index are being monitored and dis-
Figure 6
7.
When the screen displays as shown in Figure 6, press Display Key
circularly, the display screen will be switched between the two screens
(as shown in Figure 6 and Figure 7), and four directions display alternately.
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8.
Display screen (as shown in Figure 6 or Figure 7) will return to the screen
as shown in Figure 4 or Figure 5 if without operation in 10 seconds.
ENGLISH
Figure 7
9. Alarm Indicator
When measuring, if
alarm limits, the device will alarm automatically and the value on the screen
exceeding limit will blink; at this time press Display Key to shut down the
alarm. Exceeding pulse rate alarm limit: sound twice as an interval;
Preset alarm range:
SpO2
alarm: Low limit: 90%
Pulse Rate alarm: High limit 120bpm - Low limit: 50bpm.
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 55ºC ambient
temperature and less than 95% relative humidity.
The expected useful life (not guaranteed) 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.
SpO2
value and pulse rate value exceeds the preset
ENGLISH
Cleaning and Disinfecting Instruction
Surface-clean sensor with a soft cloth damped with a solution such as
75% isopropyl alcohol, if low-level disinfection is required, use a mild
bleach solution.
Then surface-clean by soft cloth damped ONLY with clean water and
let air dry or wipe it dry.
Caution: Do not sterilize by irradiation steam, or ethylene oxide.
Do not use the Pulse Oximeter if it is damaged visually.
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8. TROUBLESHOOTING
Trouble Possible Reason Solution
The SpO2
and Pulse Rate
display instable.
The device
can not turn on.
The indicator
light is off
suddenly.
1. The nger is not
placed inside enough.
2. The nger is shaking
or the patient is moving
1. The batteries are
drained or almost
drained.
2. The batteries are not
inserted properly.
3. The device’s
malfunction.
1. The device will power
off automatically when it
gets no signal for 8
seconds.
2. The batteries are
almost drained.
1. Place the nger
properly and try again.
2. Let the patient keep
calm.
1. Change batteries.
2. Reinstall batteries.
3. Please contact the
local service center.
1. Normal.
2. Change batteries.
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Declaration of Conformity:
The manufacturer hereby declares that this device complies with the
following standards:
-IEC 60601-1:2005+A1: 2012,
-IEC60601-1-2:2014,
-IEC60601-1-11:2010, ISO 80601-2-61:2011 and follows the provisions
of the council directive MDD93/42/EEC.
ENGLISH
9. KEY OF SYMBOLS
Symbol Description Symbol Description
Type BF applied part WEEE
Read instructions
carefully
Please read instructions
carefully
The pulse oxygen
%SpO2
saturation
PI Perfusion Index Product code
Pulse rate
hpm
(beats per minute)
Low battery voltage Manufacturer
Serial number Date of manufacture
Keep away from
sunlight
Keep in a cool,
dry place
Product complies with
European Directive
Lot number
(see box / package)
ENGLISH
Disposal: The product must not be disposed of along with other domestic 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
qualitative 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
extend 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 malfunctioning 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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113
Guidance and manufacturer’s declaration – electromagnetic emission
The Fingertip Oximeter is intended for use in the electromagnetic environments
specied below, the customer or the user of the Fingertip Oximeter should
assure that it is used in such an environment.
IMMUNITY TEST IEC 60601
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic eld
IEC 61000-4-8
Note:
U
TEST LEVEL
± 6 kV contact
± 8 kV air
± 2 kV for power
supply lines
± 1 kV for input/
output lines
± 1 kV line(s)
to line(s)
± 2 kV line(s)
to earth
<5% U
(>95% dip in UT)
for 0,5 cycle
<40% U
(60% dip in UT)
for 5 cycles
<70% U
(30% dip in UT)
for 25 cycles
<5% U
(>95% dip in UT)
for 5 sec
3 A/m 3 A/m Power frequency magnetic
is the a.c. mains voltage prior to application of the test level.
T
COMPLIANCE
LEVEL
± 6 kV contact
± 8 kV air
N/A
N/A
N/A
T
T
T
T
ELECTROMAGNETIC
ENVIRONMENT
GUIDANCE
Floors should be wood, concrete or ceramic tile. If oors
are covered with synthetic
material, the relative humidity
should be at least 30%.
N/A
N/A
N/A
elds should be at levels characteristic of a typical location
in a typical commercial or hospital environment.
114
Guidance and manufacturer’s declaration – electromagnetic immunity
The Fingertip Oximeter is intended for use in the electromagnetic environment
specied below. The customer or the user of the Fingertip Oximeter should
assure that it is used in such an electromagnetic environment.
IMMUNITY
TEST
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
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 af-
fected by absorption and reection from structures, objects and people.
a Field strengths from xed transmitters, such as base stations for radio (cellular/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 transmitters, an electromagnetic site survey should be considered.
If the measured eld strength in the location in which the Fingertip Oximeter is used exceeds
themapplicable 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 reorienting or relocating the device.
b Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.
IEC 60601
TEST
LEVEL
3 Vrms
150 kHz
to 80 MHz
3 V/m
80 MHz
to 2.5 GHz
COMPLIANCE
LEVEL
N/A
3 V/m
ELECTROMAGNETIC
ENVIRONMENT
GUIDANCE
Portable and mobile RF communications
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
d= 1.2 √P
d= 1.2 √P
80MHz to 800MHz
d= 2.3 √P
800MHz to 2.5GHz
Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d
is the recommended separation distance
b
in metres (m).
Field strengths from xed RF transmitters,
as determined by an electromagnetic site
survey,a should be less than the compliance level in each frequency range.b
Interference may occur in the vicinity of
equipment marked with
the following symbol:
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