Appendix
Guidance and manufacture’
Guidance and manufacture’
Guidance and manufacture’
LIFE-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.
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 rst, 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 r
device, or even damage it.
9 T
10 Symbols
11 Function Specication
T Possible Reason Solution
The SpO2 and Pulse Rate can
not be displayed normally
1. The nger is not properly positioned.
2. The patient’2 is too low to be
detected.
1. Place the nger properly and try again.
2. T
you are sure the device works all right.
The SpO2 and Pulse Rate are
not displayed stably
1. The nger is not placed inside deep
enough.
2. The nger is shaking or the patient
is moving.
1. Place the nger 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 (SpO2 ) LCD
Pulse Rate (PR) LCD
Pulse Intensity (bar LCD bar
Pulse wave LCD
SpO2 Parameter Specication
Measuring range 0%~100%, (the resolution is 1%)
Accuracy 70%~100%:±2%, Below 70% unspecied
Optical Sensor Red light (wavelength is 660nm)
Infrared (wavelength is 905nm)
Pulse Parameter Specication
Measuring range 30bpm~250bpm (the resolution is 1 bpm)
Accuracy ±2bpm or ±2% select larger
Pulse Intensity
Range Continuous bar
stronger pulse
Battery Requirement
1.5V (AAA size) alkaline batteries × 2 or rechargeable battery
Battery Useful Life
T
Dimensions and Weight
Dimensions 57(L) × 31(W) × 32(H) mm
W About 50g (with the batteries)
Guidance and manufacture’
The OXY
user of the OXY
Emission test Compliance Electr
RF emissions CISPR 11 Group 1 The OXY
nal function. Therefore, its RF emissions ar
are not likely to cause any interference in nearby electr
equipment.
RF emissions CISPR 11 Class B The OXY
ments, including domestic establishments and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Guidance and manufacture’
The OXY
user of OXY
Immunity test IEC60601
test level
Compliance level Electromagnetic environment-
guidance
Electrostatic discharge (ESD)
IEC 61000-4-2
8 kV contact
15 kV air
8 kV contact
15 kV air
Floors should be wood, concrete or
ceramic tile. If oor are covered with
synthetic material, the relative humidity
should be at least 30%. The manufacturer
may recommend the ESD precautionary
procedures to user
Power frequency (50Hz)
magnetic eld
IEC 61000-4-8
30A/m 30A/m Power frequency magnetic elds should
be at levels characteristic of a typical lo-
cation in a typical commercial or hospital
environment.
Guidance and manufacture’
The OXY
user of OXY
Immunity test IEC60601
test level
Compliance
level
Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3V
(0.15MHz–80MHz),
6V (in ISM bands
between 0.15MHz
and 80MHz)
10 V/m
80 MHz to 2.7GH
3V
(0.15MHz–80MHz),
6V (in ISM bands
between 0.15MHz
and 80MHz)
10 V/m
Portable and mobile RF communications equip-
ment should be used no closer to any part of the
OXY
separation distance calculated from the equation
applicable to the frequency of the transmitter
Recommended separation distance
80MHz to 800MHz
800MHz to 2.7GHz
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 xed RF transmitters, as deter
mined by an electromagnetic site surveya should
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:
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
reection from structur
a Field strengths from xed transmitters, such as base stations for radio (cellular/cor
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be pr
T
sidered. If the measured eld str
level above, the OXY
measures may be necessary
b Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF communications equipment and the OXY
Pulse Oximeter
The OXY
are controlled. The customer or the user of the OXY
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the OXY
3 Pulse Oximeter as recommended below
Rated maximum
output power
of transmitter (W)
Separation distance according to frequency of transmitter (m)
150KHz to 80MHz 80MHz to 800MHz 800MHz to 2.7GHz
0.01 0.058 0.035 0.07
0.1 0.18 0.11 0.22
1 0.58 0.35 0.7
10 1.83 1.10 2.21
100 5.8 3.5 7
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 transmitterP 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 af
reection from structur
M35090-GB-Rev
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 specic recycling point for electric and electronic
equipment.
Symbol Description
T
Follow instructions for use
%SpO2 The pulse oxygen saturation(%)
PRbpm Pulse rate (bpm)
The battery voltage indication
is decient (change the battery
in time avoiding the inexact
measure)
1. No nger 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
Directive 93/42/EEC
Symbol Description
Manufacturer
Date of manufacture
T
%
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
0476
Gima S.p.A.
Via Marconi, 1
20060 Gessate (MI) Italy
gima@gimaitaly
export@gimaitaly
www
Made in China
35090
IP22
0476
95%
0%
1060 hPa
500 hPa
60°C
-40°C
3.5
E 1
√P
d=
7
E 1
√P
d=
3.5
E 1
√P
d= 7
E 1
√P
d=
3.5
V 1
√P
d=
3.5
V 1
√P
d=
