Gima OXY-5 PAEDIATRIC FINGER OXIMETER User guide [ar]

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

PROFESSIONAL MEDICAL PRODUCTS

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

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

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.

M34282-M-Rev.6-03.19

34282 - 34265

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

0476

ARABIC

84

85

ARABIC

ARABIC

86

87

ARABIC

ARABIC

88

89

ARABIC

ARABIC

90

91

ARABIC

ARABIC

92

93

ARABIC

ARABIC

94

95

ARABIC

ARABIC

BF

%SpO2

PI

hpm

(

/

)

96

97

ARABIC

APPENDIX II EMC

The equipment meets the requirements of IEC 60601-1-2:2014.

Table 1

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.

Emission test Compliance Electromagnetic

RF emissions
CISPR 11

RF emissions
CISPR 11

Harmonic emissions
IEC 61000-3-2

Voltage uctuations/
icker emission
IEC 61000-3-3

Group 1 The Fingertip Oximeter uses RF

Class B The Fingertip Oximeter suitable

N/A

N/A

environment-guidance

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.

for use in all establishments,
including domestic establishments
and those directly network that
supplies buildings used for
domestic purposes.

98

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

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
(50/60Hz)
magnetic eld
IEC 61000-4-8

test level

±6kV contact
±8kV air

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

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

<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

3A/m 3A/m Power frequency

Compliance
level

±6kV
contact
±8kV air

Electromagnetic
environment-guidance

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

N/A N/A

N/A N/A

N/A N/A

magnetic elds should
be at levels characteris­tic 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.

Guidance and manufacturer’s declaration – electromagnetic immunity

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 electromagnetic environment.

Immunity
test

Conducted
RF IEC
61000-4-6

Radiated
RF IEC
61000-4-3

IEC60601
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

80MHz to 800MHz

d= 1.2 √P

800MHz to 2.5GHz

d= 2.3 √P

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 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.
Interference may occur in the vi­cinity of equipment marked
with the following
symbol.

b

b

100

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 (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 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.

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 communi­cations equipment (transmitters) and the Fingertip Oximeter as recommend­ed below, according to the maximum output power of the communications
equipment.

Rated
maximum
output
power of
transmitter
W (Watts)

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 P is 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 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 (Meters

150KHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz

d= 1.2 √P

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

d= 1.2 √P d= 2.3 √P

102

103