Repairing And Maintenance; Troubleshooting; Function Specification - Gima OXY-3 Manual De Instrucciones

8 Repairing and Maintenance

• Please change the batteries when the low-voltage displayed on the screen.
• Please clean the surface of the device before using. Wipe the device with medical alcohol first, and then let it dry in air or
clean it by dry clean fabric.
• Using the medical alcohol to disinfect the product after use, prevent from cross infection for next time use.
• Please take out the batteries if the oximeter is not in use for a long time.
• The best storage environment of the device is - 40ºC to 60ºC ambient temperature and not higher than 95% relative
humidity.
• 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

Trouble Possible Reason
The SpO and Pulse Rate can 1. The finger is not properly positioned.
2
not be displayed normally. 2. The patient's SpO
detected.
The SpO and Pulse Rate are 1. The finger is not placed inside deep
2
not displayed stably. enough.
2. The finger is shaking or the patient
is moving.
The device can not be 1. The batteries are drained or almost
turned on. drained.
2. The batteries are not inserted
properly.
3. The malfunction of the device.
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.
10 Symbols
Symbol Description
Type BF applied part
Follow instructions for use
%SpO The pulse oxygen saturation(%)
2
PRbpm
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. Change brightness of the
screen
2. Exit standby mode
Serial number
Alarm inhibit
WEEE disposal
IP22
Covering Protection rate
Medical Device complies with
0476
Directive 93/42/EEC

11 Function Specification

Display Information
The Pulse Oxygen Saturation (SpO )
2
Pulse Rate (PR)
Pulse Intensity (bar-graph)
Pulse wave
SpO Parameter Specification
2
Measuring range
Accuracy
Optical Sensor
Pulse Parameter Specification
Measuring range
Accuracy
Pulse Intensity
Range
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
Weight
Solution
1. Place the finger properly and try again.
is too low to be 2. Try again; go to a hospital for a diagnosis if
2
you are sure the device works all right.
1. Place the finger 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.
Symbol Description
Manufacturer
Date of manufacture
Temperature limit
%
Humidity limit
Atmospheric pressure limit
This side up
Fragile, handle with care
Keep in a cool, dry place
Recyclable
Caution: read instructions
(warnings) carefully
Product code
Lot number
Keep away from sunlight
Display Mode
LCD
LCD
LCD bar-graph display
LCD
0%~100%, (the resolution is 1%)
70%~100%:±2%, Below 70% unspecified
Red light (wavelength is 660nm)
Infrared (wavelength is 905nm)
30bpm~250bpm (the resolution is 1 bpm)
±2bpm or ±2% select larger
Continuous bar-graph display, the higher display indicate the
stronger pulse
57(L) × 31(W) × 32(H) mm
About 50g (with the batteries)
Appendix
Guidance and manufacture's declaration-electromagnetic emission for all EQUIPMENT and SYSTEMS
Guidance and manufacture's declaration – electromagnetic emission
The OXY-3 Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the
user of the OXY-3 Pulse Oximeter should assure that it is used in such an environment.
Emission test Compliance
RF emissions CISPR 11 Group 1
RF emissions CISPR 11 Class B
Guidance and manufacture's declaration-electromagnetic immunity for all EQUIPMENT and SYSTEMS
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
Electrostatic discharge (ESD) 8 kV contact
IEC 61000-4-2 15 kV air
Power frequency (50Hz) 30A/m
magnetic field
IEC 61000-4-8
Guidance and manufacture's declaration-electromagnetic immunity for EQUIPMENT and SYSTEMS that are not
LIFE-SUPPORTING
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 Compliance
test level level
Conducted RF 3V 3V
IEC 61000-4-6 (0.15MHz–80MHz), (0.15MHz–80MHz),
6V (in ISM bands 6V (in ISM bands
between 0.15MHz between 0.15MHz
and 80MHz) and 80MHz)
10 V/m 10 V/m
Radiated RF 80 MHz to 2.7GH
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 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 broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be con-
sidered. If the measured field strength in the location in which the OXY-3 is used exceeds the applicable RF compliance
level above, the OXY-3 should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the OXY-3.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF communications equipment and the EQUIP-
MENT or SYSTEM for EQUIPMENT or SYSTEM that not LIFE-SUPPORTING.
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 Separation distance according to frequency of transmitter (m)
output power
of transmitter (W)
150KHz to 80MHz
3.5
√ P
d=
V
1
0.01 0.058
0.1 0.18
1 0.58
10 1.83
100 5.8
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 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.
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.
35090
Gima S.p.A.
Via Marconi, 1
20060 Gessate (MI) Italy
gima@gimaitaly.com
export@gimaitaly.com
www.gimaitaly.com
Made in China
-40°C
Electromagnetic environment-guidance
The OXY-3 Pulse Oximeter uses RF energy only for its inter-
nal function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby electronic
equipment.
The OXY-3 Pulse Oximeter is suitable for use in all establish-
ments, including domestic establishments and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Compliance level Electromagnetic environment-
guidance
8 kV contact Floors should be wood, concrete or
15 kV air ceramic tile. If floor are covered with
synthetic material, the relative humidity
should be at least 30%. The manufacturer
may recommend the ESD precautionary
procedures to user.
30A/m Power frequency magnetic fields should
be at levels characteristic of a typical lo-
cation in a typical commercial or hospital
environment.
Electromagnetic environment - guidance
Portable and mobile RF communications equip-
ment should be used no closer to any part of the
OXY-3, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
3.5
d= √P
V
1
3.5
√P
d=
80MHz to 800MHz
E
1
7
d= √P
800MHz to 2.7GHz
E
1
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 metres (m).
Field strengths from fixed RF transmitters, as deter-
mined by an electromagnetic site survey,
be less than the compliance level in each frequency
range. b
Interference may occur in the vicinity
of equipment marked with the follow-
ing symbol:
80MHz to 800MHz 800MHz to 2.7GHz
3.5
√ P
d= d=
E
1
0.035
0.11
0.35
1.10
3.5
60°C 95% 1060 hPa
IP22
0% 500 hPa
a should
7
√ P
E
1
0.07
0.22
0.7
2.21
7
0476