Gima 35091, 35092, 35093, OXY-4 User guide

Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
[email protected] - [email protected]

PROFESSIONAL MEDICAL PRODUCTS

www.gimaitaly.com

PULSOXIMETRO OXY-4
OXY-4 PULSE OXIMETER
OXYMÈTRE OXY-4
PULOXIMETER OXY-4
OXÍMETRO OXY-4
OXÍMETRO DE PULSO OXY-4
KOPEΣTOMETPO OXY-4
OKSYMETR OXY-4

MANUALE D’USO E MANUTENZIONE

INSTRUCTIONS DE FONCIONNEMENT ET ENTRETIEN

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.

35091 - 35092 - 35093

Gima S.p.A
Via Marconi, 1
20060 Gessate (MI) - Italy
Made in China

M35091-M-Rev.3-07.19

USE AND MAINTENANCE BOOK

BETRIEBS UND WARTUNGS ANWEISUNGEN

MANUAL DE USO Y MANTENIMIENTO

MANUAL DE USO E MANUTENÇÃO

ΕΓΧΕΙΡΙΔΙΟ ΧΡΗΣΗΣ ΚΑΙ ΣΥΝΤΗΡΗΣΗΣ

PODRĘCZNIK EKSPLOATACJI I KONSERWACJI

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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 abnormality,
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 contents contained in this manual are subject to change without
notice.

- 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- If any abnormal condition is found, please
change the position of Pulse Oximeter.

- 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.- 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 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 affectpatient’s safety and
monitoring performance with regard to sensors and clips. It is recom­mended 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 tech­nicians ONLY. Users are not permitted to maintain it by themselves.

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

ries not specied in Use’s Manual.

- Special attention should be paid while the Pulse Oximeter is used

constantly when the ambient temperature over 37°C, burning hurt
may occur because of over-heating of the sensor at this situation.

1.2 Attentions

- Keep the oximeter away from dust, vibration, corrosive sub­stances, 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 oper­ation until it is dry and checked for correct operation. When it is car­ried from cold environment to warm and humid environment, please
do not use it immediately. Allow at least 15 minutes for Pulse Oximeter
to reach ambient temperature.

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

- High temperature or high pressure steam disinfection to the oximeter
is not permitted. Refer to User’s Manual for instructions of cleaning
and disinfection.

- 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 emitting light from the device.

- Ensure that there is artery vessel within measuring site where the light
transmits through.

- Vigorous exercise and the interference from the electrosurgical device
may affect 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 ex­pected by waiting for a while, or a restart is needed when necessary.

2. OVERVIEW

SpO2 is the saturation percentage of oxygen in the blood, so called O
concentration in the blood; it is dened by the percentage of oxyhemo-

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globin (HbO2) in the total hemoglobin of the arterial blood. SpO2 is an
important physiological parameter to reect the respiration function; it is
calculated by the following method:

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SpO2 = HbO2/ (HbO2 +Hb)×100%

HbO2 are the oxyhemoglobins (oxygenized hemoglobin), Hb are those
hemoglobins which release oxygen.

2.1 Features

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

mogram.

- Innovative 4 directions display.

- Automatic power on/off.

- Audible & visible over-limit indication.

- Shift parameter display between PR and PI.

2AAA alkaline batteries with low power consumption.

- Low battery voltage indication.

Lanyard Hole

Display

Battery Cover

Lock button of

battery cover

Nameplate

Display Key

Rubber Cushion

Figure 1

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2.2 Major Applications and Scope

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 SpO2 value will appear on the screen imme­diately.
The Fingertip Oximeter can detect SpO2 and pulse rate through pa­tient’s nger.
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 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, reecting and attenuation in tissue can reect
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 can be determined. SpO2 measured by this Pulse Oximeter
is 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: SpO2 is an important phys-
iological parameter to reect the respiration and ventilation function,
so SpO2 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 SpO2 can be determined in timely manner

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by measurement and will allow nding the hypoxemia patient earlier,
thereby preventing or reducing accidental death caused by hypoxia
effectively.

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,

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.

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.

2.4 Caution

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

or else it may cause inaccurate measurement.

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

ranged 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

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arterial canal or blood pressure cuff or receiving intravenous injec­tion.

D. Do not x the SpO2 sensor 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

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.

3. BATTERY INSTALLATION

1. Press the lock button of the battery cover, meanwhile, pull the cover

back and take it out.

2. Refer to Figure 2, insert two AAA size batteries into the battery com-

partment properly.

3. Replace the cover. Please make sure that the batteries are correctly

installed since the incorrect installation may cause the device inoper­able.

Figure 2
Battery Installation

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4. OPERATION

4.1 Start Measurement

1. Open the clip as shown in Figure 3.

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

in the correct position), and then clip the nger.

3. The device will power on automatically in 2 seconds, and start to dis-

play software 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 B1 Figure 4 B2

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

Screen Description:

“%SpO2”: The title of SpO2; “99”: SpO2 value, unit:%;
“PR”: The title of Pulse Rate; “65”: Pulse Rate value, unit: bpm (beat
per minute);
“ ”: Pulse beat icon;
“�”: Pulse bar-graph;
“PI%”: The title of Perfusion Index; “1.4”: Perfusion Index value, unit:
%;;
“ ”: Battery power indicator.

5. Change display direction

Four directions display alternately. Short time press “Display Key” to

ip the screen 90° each time in a cyclical manner as shown in Figure

4. When the screen displays towards the left side, the plethysmogram
will be viewed.

6. Shift parameter display between PR and PI during measurement Long

time press the “Display Key”, shift the parameter display between PR
and PI. But when the PR is shifted to PI display and no button oper­ation is performed after 20 seconds, the PI will change to PR display
automatically.

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4.2 Over-limit indication and Beep Silence

When measuring, if SpO2 value or pulse rate value exceeds the limit,
the device will beep automatically and the value which exceeds its limit
will ash on the screen (Refer to chapter 4 for the detailed information).
When the beep sound is activated by over-limit, it will become silent or
d-active at the following situations:

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 automatically 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 optical 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

C. Perfusion Index (PI) Display

Range: 0.2%~20%

D. Audible & visual over-limit indication

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

the device will beep automatically and the value which exceeds its
limit will ash on the screen. The Oximeter will shut down automati­cally in 8 seconds with no signal.

E. Display: Color OLED Display
F. Power supply requirement:

2 x LR03 (AAA) alkaline batteries
Working voltage: 2.2V~3.3VDC
Operating current: ≤40mA

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G. Environment requirement

Operating Temperature: 5 ~40°C
Operating Humidity: 30~80%
Atmospheric pressure: 70~106kPa

H. The performance under low perfusion condition

The accuracy of SpO2 and PR measurement still meets the specica-

tion described above when the pulse modulation amplitude is as low
as 0.6%.

I. Resistance to ambient light interference:

The accuracy of SpO2 and PR measurement still meets the speci-

cation described above when the device is tested by SpO2 simulator
(Fluke Biomedical Index 2 series) while setting the emulating interfer­ence of sun light and 50Hz/60Hz uorescent light.

J. Dimensions: 60 mm (L) × 33 mm (W) × 30 mm (H)
Net Weight: 35g (including battery)

K. Classication:

The type of protection against electric shock: Internally powered

equipment.

The degree of protection against electric shock: Type BF applied

parts.

The degree of protection against harmful ingress of liquids: Ordinary

equipment without protection against ingress of water.

Electro-Magnetic Compatibility: Group I, Class B.

6. ACCESSORIES

A. A lanyard
B. Two batteries
C. A carrying pouch
D. A User Manual

Note: The accessories are subject to change. Detailed items and
quantity see the Packing List.

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7. REPAIR AND MAINTENANCE

The expected service life (not a warranty) of this device is 5 years. In
order to ensure its long service life, please pay attention to the use of
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 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 batteries 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 ambient temperature and 10% to 95% relative humidity with
atmospheric pressure: 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 routinely, the user can do the verication by
means of SpO2 simulator, or it can be done by the local third party
testing house.

7.1 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

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

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8. TROUBLESHOOTING

Trouble Possible Reason Solution

The SpO2
and Pulse Rate
display instable

Cannot turn on
the device

No display

Declaration 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 coun­cil directive MDD93/42/EEC.

1. The nger is not placed
far enough inside.

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 is
malfunctioning.

1. The device will power
off automatically when it
gets no signal for 8 s.

2. The batteries are almost
drained.

1. Place the nger
correctly inside 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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9. KEY OF SYMBOLS

Symbol Description Symbol Description

Type BF applied part WEEE disposal

Caution: read
instructions
(warnings) carefully

Follow instructions
for use

Oxygen saturation

%SpO

2

(percentage)

Pulse rate

PR

(beats per minute)

Pulse beat icon Lot number

Low battery voltage Manufacturer

Serial number Date of manufacture

Keep away from
sunlight

Keep in a cool,
dry place

Medical Device
complies with Directive
93/42/EEC

Product code

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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 specic 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, nes 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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ELECTROMAGNETIC COMPATIBILITY INFORMATION

Table 1: Guidance and manufacturer’s declaration - electromagnet­ic emissions

The device is intended for use in the electromagnetic environment spec­ied below. The user of this device should assure that it is used in such
an environment.

Emissions test Compliance Electromagnetic environment

RF emissions
CISPR 11

RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage uctuations/
icker emissions
IEC 61000-3-3

Table 2: Guidance and manufacturer’s declaration - electromagnet­ic immunity

The device is intended for use in the electromagnetic environment spec­ied below. The user of this device 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
IEC61000-4-4

Group 1

Class B

N/A

N/A

test level1

±6 kV contact
±8 kV air

±2 kV for power
supply lines
±1 kV for
input/output lines

This device uses RF energy only for its
internal function. Therefore, its RF emis­sions are very low and are not likely to
cause any interference in nearby electron­ic equipment.

This device is suitable for use in all estab­lishments. It uses internal power supply
and has no connection with power supply
network.

Compliance
level

±6 kV contact
±8 kV air

N/A N/A

Electromagnetic
environment

Floors should be wood,
concrete or ceramic tile.
If oors are covered with
synthetic material, the
relative humidity should be
at least 30%.

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Surge
IEC 61000-4-5

Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11

Power frequency
(50/60Hz)
magnetic eld
IEC61000-4-8

Note: U

Table 3: Guidance and manufacturer’s declaration – electromagnet­ic immunity

The device is intended for use in the electromagnetic environment spec­ied below. The user of this device should assure that it is used in such
an environment.

NOTA 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTA 2: These guidelines may not apply in all situations. Electromagnetic propagation

is affected by absorption and reection from structures, objects and people.

±1 kV line (s)
to line(s)
±2 kV line(s)
to earth

<5 % UT
(>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 s

3 A/m 3 A/m Power frequency magnetic

T

is the a.c. mains voltage prior to application of the test level.

T

T

T

N/A N/A

N/A N/A

elds should be at levels
characteristic of a typical
location in a typical com­mercial or hospital envi­ronment.

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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, and electro­magnetic site survey should be considered. If the measured eld strength in the loca­tion in which the device is used exceeds the applicable RF compliance level above,
the device should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating
this device.
b: Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than
3V/m.

Immunity
test

Conducted RF
IEC 61000-4-6

Radiated RF
IEC 61000-4-3

IEC 60601
test level

3 Vrms
da 150 kHz
80 MHz

3 V/m
da 80 MHz
2,5
GHz

Compliance
Level

N/A

3 V/m

Electromagnetic environment

Portable and mobile RF communications
equipment should be used no closer to
any part of this device, 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 in meters (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.
Interference may occur in the
vicinity of equipment
marked with
the following symbol:

b

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Table 4: Recommended separation distances between portable and
mobile RF communications equipment and the device

The device is intended for use in an electromagnetic environment in
which radiated RF disturbances are controlled. The user of this device
can help prevent electromagnetic interference by maintaining a mini­mum distance between portable and mobile RF communications equip­ment (transmitters) and this device as recommended below, according
to the maximum output power of the communications equipment.

Rated
maximum
output power
of transmitter
W

For transmitters rated at a maximum output power not listed above, the recommend­ed separation distance d in meters (m) can be estimated using the equation applica­ble to the frequency of the transmitter, where P is the maximum output power rating of
the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for 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.

Separation distance according to frequency of transmitter m

150 kHz to MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz

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