Net Weight:
approx. 60g (including batteries)
H.Classification
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 solid foreign objects
and ingress of liquid:
The equipment is
IP22
with protection against harmful solid
foreign objects and ingress of liquid.
Electro-Magnetic Compatibility:
Group I, Class B
8 Maintenance and Cleaning&Disinfection
8.1 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
maintenance.
Please change the batteries when the low-voltage indicator
lightens.
Please clean the surface of the device before using, with 75%
alcohol wipes, then let it air dry or wipe it dry. Do not allow liquid
to enter the device.
Please take out the batteries if the Oximeter will not be used any
more than 7 days.
The recommended storage environment of the device:
ambient temperature: -20 ºC - 60 ºC, relative humidity 10% - 95%,
atmospheric pressure: 50 kPa - 107.4 kPa.
The Oximeter is calibrated in the factory before sale, so there is no
need to calibrate it during its life cycle.
Caution:
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 life of the device, or
even damage it.
8.2 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 with a cloth damped ONLY with clean water
and dry with a clean, soft cloth.
Caution:
Do not sterilize by irradiation steam, or ethylene oxide.
Do not use the Oximeter if it is damaged.
9 Troubleshooting
Problem
Solution
The SpO
2
and Pulse
Rate value are
unstable
Place the finger correctly inside and try again.
Keep calm.
Cannot turn on the
device
Change or re-install the batteries.
No display
Change the battery.
10 Symbols
Symbol
Description
Symbol
Description
CE mark
Authorised
representative in the
European community
SN
Serial number
Manufacturer (including
address)
Date of manufacture
BF type applied part
Attention ─ refer to
User Manual
Follow WEEE
regulations for disposal
UK Responsible Person
Appendix 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
specified below. The customer or the user of the Fingertip Oximeter should assure
that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment-guidance
RF emissions
CISPR 11
Group 1
The Fingertip Oximeter 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.
RF emissions
CISPR 11
Class B
The Fingertip Oximeter suitable for use in all
establishments, including domestic
establishments and those directly network
that supplies buildings used for domestic
purposes.
Harmonic emissions
IEC61000-3-2
N/A
Voltage
fluctuations/flicker
emissions
IEC61000-3-3
N/A
Table 2
Guidance and manufacturer’s declaration-electromagnetic emission
The Fingertip Oximeter is intended for use in the electromagnetic environment
specified below. The customer or the user of the Fingertip Oximeter should assure
that it is used in such an environment.
Immunity test
IEC60601 test level
Compliance
level
Electromagnetic
environment -guidance
Electrostatic
discharge(ESD)
IEC61000-4-2
±8 kV contact
±15kV air
±8 kV
contact
±15kV air
Floors should be wood,
concrete or ceramic tile.
if floors are covered
with synthetic material,
the relative humidity
should be at least 30%
Electrical fast
transient/
burst
IEC61000-4-4
±2kV for power
Supply lines
±1 kV for input/output
lines
N/A
N/A
Surge
IEC 61000-4-5
±1kV line (s) to line(s)
±2kV line(s) to earth
N/A
N/A
Voltage dips,
short
interruptions and
voltage
variations on
power supply
input lines
IEC61000-4-11
<5%
U
T
(>95% dip in
U
T
) for 0.5
cycle
<40%
U
T
(60% dip in
U
T
) for 5
cycles
<70%
U
T
(30% dip in
U
T
) for 25
cycles
<5%
U
T
(>95% dip in
U
T
) for 5 s
N/A
N/A
Power frequency
(50Hz/60Hz)
magnetic field
IEC61000-4-8
3A/m
3A/m
Power frequency
magnetic fields should
be at levels
characteristic of a
typical location in a
typical commercial or
hospital environment.
NOTE: U
T
is the a.c. mains voltage prior to application of the test level.
Table 3
Guidance and manufacturer’s declaration – electromagnetic immunity
The Fingertip Oximeter is intended for use in the electromagnetic environment
specified below. The customer or the user of The Fingertip Oximeter should assure
that it is used in such an electromagnetic environment.
Immunity test IEC60601 test
level
Compliance
level
Electromagnetic environment
-guidance
Conducted RF
IEC61000-4-6
Radiated RF
IEC61000-4-3
3 Vrms
150 kHz to 80
MHz
3 V/m
80 MHz to 2.5
GHz
N/A
3 V/m
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
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 metres (m).
b
Field strengths from fixed RF
transmitters, as determined 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 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, and
electromagnetic site survey should be considered. If the measured field 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, field strengths should be less than
3V/m.
Table 4
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)
Separation distance according to frequency of transmitter
M(Meters)
150kHz to 80MHz
d=1.2
P
80MHz to 800MHz
d=1.2
P
80MHz to 2,5GHz
d=2.3
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
For transmitters rated at a maximum output power not listed above, the
recommended separation distance in metres (m) can be determined 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 reflection from structures, objects and
people.
