optional, the default is “Spot check”.
Spot check mode: the measuring time lasts 30 seconds with a
counting-down indication. The SpO2 and PR readings will freeze at
the end of 30 seconds, the analysis result for the pulse rhythm will
be displayed on the screen as well.
Continuous mode: measurement will start automatically when
finger is inserted into the oximeter, SpO2 and PR readings will be
displayed until the finger is removed from the oximeter.
6 Record List
A single group of stable readings will be recorded in the record list
each time when the oximeter shuts down regardless of spot-check
or continuous mode. However, if the time from displaying valid
readings to the end of measurement is less than 5 seconds, then no
recording will be done.
Up to 12 groups of records can be stored in the record list, the
newest record is marked as M1, and the oldest record is marked as
M12. The new record will override the previous record.
When batteries are removed from the device all readings will be
deleted.
On power off status, long pressing the Display key shows the record
list screen. On record list screen, a short pressing on the Display key
can shift the records display, and if there is no key operation for 6
seconds, then the oximeter will power off automatically again.
7 Technical Specifications
A. SpO2 Measurement
Sensor: dual-wavelength LED sensor with wavelength:
Red light: 663 nm, Infrared light: 890 nm.
Maximal average optical output power: ≤2mW
SpO2 display range: 35% - 100%
SpO2 measuring accuracy: ≤ 2% for SpO2 range from 70% to 100%
B. Pulse Rate measurement
PR display range: 30 bpm – 240 bpm
PR measuring accuracy: ±2bpm or ±2% (whichever is greater)
C. Perfusion Index (PI) Display range
0% - 20%
D. Over-limit settings
SpO2:
Low limit setting range: 85% - 99%, step: 1%
Default setting: 90%
Pulse Rate:
Low limit setting range: 30 - 60 bpm, step: 1bpm;
High limit setting range: 100 - 240 bpm, step: 5bpm;
Default setting: high: 120bpm; low: 50bpm
E. Audible & visual alert function
When measuring, if SpO2 value or pulse rate value exceeds the
preset limit, the device will alert with beep automatically and the
value which exceeds limit will flash on the screen.
F. Power supply requirement
2 x LR03 (AAA) alkaline batteries
Supply voltage: 3.0VDC, Operating current: ≤40mA
G. Environmental Conditions
Operating Temperature: 5°C - 40°C
Operating Humidity: 30% - 80%
Atmospheric pressure: 70kPa - 106kPa
H. Low Perfusion Performance
The accuracy of SpO2 and PR measurement still meet the precision
described above when the modulation amplitude is as low as 0.6%.
I. Ambient Light Interference
The difference between the SpO2 value measured in the condition
of indoor natural light and that of darkroom is less than ±1%.
J. Dimensions: 56 mm (L) × 34 mm (W) × 30 mm (H)
Net Weight: approx. 60g (including batteries)
K. 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. Any SpO2 simulators should
not be used to validate the accuracy of the Oximeter, they can only
be used as functional testers to verify its precision. The SpO2
accuracy claimed in this manual is supported by the clinical study
conducted by inducing hypoxia on healthy, non-smoking, light-to-
dark skinned subjects in an independent research laboratory.
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
10 Symbols
Symbol Description Symbol Description
CE mark
representative in the
European community
SN Serial number
address)
Date of manufacture BF type applied part
Attention ─ refer to
User Manual
Follow WEEE
regulations for disposal
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
that it is used in such an environment.
Emissions test Compliance Electromagnetic environment-guidance
RF emissions
CISPR 11 Group 1
The Fingertip Oximeter
its internal function. Therefore, its RF
emissions are very low and are not likely to
cause any interference in nearby electronic
RF emissions
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
fluctuations/flicker
emissions
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
Immunity test IEC60601 test level
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
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% 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
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
NOTE: UT 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 -
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 P80MHz to 800MHz
d=2.3 P800MHz 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
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 envir
onment 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 shoul
d 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 th
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
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
mum output power of the communications equipment.
Rated maximum
output power of
transmitter
W(Watts)
Separation distance according to frequency of transmitter
d=1.2 P
d=1.2 P
d=2.3 P
0,01 N/A 0.12 0.23
1 N/A 1.2 2.3
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.
Problem Solution
The SpO2 and Pulse
Rate value instable
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.
