Appendix
Guidance and manufacture’s declaration-electromagnetic emission for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration-electromagnetic immunity for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration-electromagnetic immunity for EQUIPMENT and SYSTEMS that are not LI-
FE-SUPPORTING
Recommended separation distances between portable and mobile RF communications equipment and the EQUIP-
MENT or SYSTEM for EQUIPMENT or SYSTEM that not LIFE-SUPPORTING.
• Users are advised to calibrate the device termly (or according to the calibrating program of hospital). It also can be per-
formed at the state-appointed agent or just contact us for calibration.
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.
9 Troubleshooting
10 Key of Symbols
11 Function Specification
Trouble
Possible Reason
Solution
The SpO
2
and Pulse Rate can
not be displayed normally.
1. The finger is not properly positioned.
2. The patient’s SpO
2
is too low to be
detected.
1. Place the finger properly and try again.
2. Try again; go to a hospital for a diagnosis if
you are sure the device works all right.
The SpO
2
and Pulse Rate are
not displayed stably.
1. The finger is not placed inside deep
enough.
2. The finger is shaking or the patient
is moving.
1. Place the finger properly and try again.
2. Let the patient keep calm.
The device can not be
turned on.
1. The batteries are drained or almost
drained.
2. The batteries are not inserted
properly.
3. The malfunction of the device.
1. Change batteries.
2. Reinstall batteries.
3. Please contact the local service center.
The display is off suddenly.
1. The product will enter standby mode
when no signal is in the product within
5 seconds.
2. The batteries are almost drained.
1. Normal.
2. Change batteries.
Display Information
Display Mode
The Pulse Oxygen Saturation (SpO
2
)
OLED
Pulse Rate (PR)
OLED
Pulse Intensity (bar-graph)
OLED bar-graph display
Pulse wave
OLED
SpO
2
Parameter Specification
Measuring range
0%~100%, (the resolution is 1%)
Accuracy
70%~100%:±2%, Below 70% unspecified
Optical Sensor
Red light (wavelength is 660nm)
Infrared (wavelength is 880nm)
Pulse Parameter Specification
Measuring range
30bpm~250bpm (the resolution is 1 bpm)
Accuracy
±2bpm or±2% select larger
Pulse Intensity
Range
Continuous bar-graph display, the higher display indicate the
stronger pulse
Battery Requirement
1.5V (AAA size) alkaline batteries × 2 or rechargeable battery
Battery Useful Life
Two batteries can work continually for 20 hours
Dimensions and Weight
Dimensions
57(L) × 31(W) × 32(H) mm
Weight
About 50g (with the batteries)
Guidance and manufacture’s declaration – electromagnetic emission
The OXY-3 Pulse Oximeter is tended for use in the electromagnetic environment specified below. The customer of the
user of the OXY-3 Pulse Oximeter should assure that it isused in such an environment.
Emission test
Compliance
Electromagnetic environment-guidance
RF emissions CISPR 11
Group 1
The OXY-3 Pulse Oximeter uses RF energy only for their in-
ternal function. 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 OXY-3 Pulse Oximeter is suitable for use in all establi-
shments, including domestic establishments and those
directly connected to the public low-voltage power supply
network that supplies buildings used for domestic purpo-
ses.
Harmonic emissions IEC 61000-3-2
Not applicable
Voltage fluctuations/ flicker emission
IEC 61000-3-3
Not applicable
Guidance and manufacture’s declaration-electromagnetic immunity
The OXY-3 Pulse Oximeter is intended for use in the electromagnetic environment specified specified below. The the
user of OXY-3 Pulse 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 cera-
mic tile. If floor are covered with synthetic
material, the relative humidity should be
at least 30%.
Power frequency (50Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields should
be at levels characteristic of a typical lo-
cation in a typical commercial or hospital
environment.
Guidance and manufacture’s declaration-electromagnetic immunity
The OXY-3 Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the
user of OXY-3 Pulse Oximeter should assure that it is used in such an environment.
Immunity test
IEC60601 test
level
Compliance level
Electromagnetic environment -guidance
Radiated RF
ICE 61000-4-3
3V/m
80MHz to 2.5GHz
3 V/m
Portable and mobile RF communication equip-
ment should be used no closer to any part of the
OXY-3 Pulse 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
P
is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and
d
is the recommended separa-
tion distance in meters (m).
Field strengths from fixed RF transmitters, as de-
termined 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:
NOTE 1
At 80MHz and 800MHz, the higher frequency range applies.
NOTE 2
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcastcannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be consi-
dered. If the measured field strength in the location in which The OXY-3 Pulse Oximeter is used exceeds the applicable
RF compliance level above, the OXY-3 Pulse Oximeter should be observed to verify normal operation. If abnormal perfor-
mance is observed, additional measures may be necessary, such as reorienting or relocating the OXY-3 Pulse Oximeter.
b
Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3V/m.
3.5
E
1
√P
d=
7
E
1
√P
d=
Recommended separation distances between portable and mobile RF communications equipment and the OXY-3
Pulse Oximeter
The OXY-3 Pulse Oximeter is intended for use in the electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the OXY-3 Pulse Oximeter can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the OXY-
3 Pulse Oximeter as recommended below, according to the maximum output power of the communications equipment.
Rated maximum
output power
of transmitter (W)
Separation distance according to frequency of transmitter (m)
150KHz to 80MHz
80MHz to 800MHz
800MHz to 2.5GHz
0.01
0.3500
0.3500
0.2334
0.1
1.1068
1.1068
0.7378
1
3.5000
3.5000
2.3334
10
11.0860
11.0860
7.3786
100
35.0000
35.0000
23.3334
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
reflection from structures, objects and people.
3.5
V
1
√ P
d
=
3.5
E
1
√ P
d
=
7
E
1
√ P
d
=
Gima S.p.A.
Via Marconi, 1
20060 Gessate (MI) Italy
Made in China
(P.R.C.)
35090
0476
IP22
Symbol
Description
Type BF
Refer to instruction manual/booklet
%SpO
2
The pulse oxygen saturation(%)
FCbpm
Pulse rate (bpm)
The battery voltage indication is deficient (change the battery in time avoiding the inexact
measure)
1. No finger inserted
2. An indicator of signal inadequacy
Battery positive electrode
Battery cathode
1. Exit standby mode
2. Change brightness of the screen
SN
Serial number
Alarm inhibit
WEEE (2002/96/EC)
IP22
International Protection
This item is compliant with Medical Device Directive 93/42/EEC of June 14, 1993,
a directive of the European Economic Community
Manufacturer
Manufacture Date
Storage and Transport Temperature limitation
Storage and Transport Humidity limitation
Storage and Transport Atmospheric pressure limitation
This side up
Fragile, handle with care
Keep dry
Recyclable
+60°C
-40°C
%
95%
0%
106kPa
50kPa
0476
M-35090-GB-Rev
.0.03.18
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 equi-
pment. 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.
