User's Manual

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, SpO
2
and PR
readings will be displayed until the f inger is removed from
the oximeter.
 “Display”: The display screen is always on by default. You can
set the display to automatically turn off after 5 minutes, 3
minutes, or 1 minute. Wake the screen by pressing the display
key.
7RecordList
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.
 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.
8 Technical Specifications
Classification
The type of protection
Internally powered equipment
The degree of protection
Type BF applied parts
Electro‐magnetic
Group I, Class B
Environment
Operating Storage
Temperature 5 ‐ 40°C ‐20 ‐ 55°C
Relative humidity 30% ‐ 80% 10% ‐ 93%
Atmospheric pressure 700 ‐ 1060hPa 700 ‐ 1060hPa
Degree of dust & water
IP22
Physical
Dimension 64mm*38mm*28mm
Weight 37 g
Display OLED
Wireless Bluetooth 4.0 BLE
Vibration source low oxygen level; high/low pulse rate
Power and supply
Input DC 5V ±10%
Battery Rechargeable Lithium‐polymer
Battery life 24 hours for typical use
Charge time About 3.5 hours
SpO
2
Oxygen level range
Measuring range: 35% ‐ 100%
SpO
2
Accuracy (Arms)
±
2% (70% ‐ 100%);
±
3% (50% ‐ 69%);
Pulse Rate range 30bpm ‐ 250 bpm
Pulse Rate accuracy ±2 bpm or ±2% , whichever is greater
SpO2 Low limit setting 85% ‐ 99%
Pulse R ate low limit 30bpm ‐ 60 bpm
Pulse Rate high limit 100bpm ‐ 240 bpm
Perfusion Index (PI)
0% ‐ 20%
Low perfusion The accuracy of SpO
2
and PR measurement still
Sensor Dual‐wavelength LED sensor with wavelength
Wavelength Red light: 663 mm; Inf rared light: 890 m m
Maximal average optical
≤2mW
Ambient light ThedifferencebetweentheSpO
2
value
Data update
＜
10s
Recorded parameters Oxygen level, Pulse Rate
9 Maintenance and Cleaning
9.1 Maintenance
The expected s ervice 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 Oximeter is calibrated in the factory before sale, so there is no need to
calibrate it during its life cycle. Any SpO
2
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 SpO
2
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.
9.2 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 irradiationsteam,orethyleneoxide.
 Do not use the Oximeter if it is damaged.
10 Troubleshooting
11 Symbols
Symbol Description
Manufacturer
Date of manufacture
SN Serial number
Indicates a medical device that is not to be disposed of as
unsorted municipal waste.
Follow Instructions for Use.
Type BF Applied Part
MRI unsafe. Presents hazards in all MR environments as device
contains strongly ferromagnetic materials.
IP22 Resistant to liquid ingress
No alarm system
CE marking
Authorized representative in the European community
UKCA marking
Authorized Representative in the United Kingdom
This product complies with the rules and regulations of the
Federal Communication Commission.
Non‐ionizing radiation
Our products and packaging can be r ecycled, don't throw them
away! Find where to drop them off on the
www.quefairedemesdechets.fr si te (Only applicable for French
market).
Appendix EMC
The equipment meets the requirements of IEC 60601‐1‐2:2014.
Table 1
Guidance and manufacturer’s declaration‐electromagnetic e mission
The Fingertip Oximeter is intended for u se 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 e nvironment‐guidance
RF emissions
CISPR 11
Group 1
The Fingertip Oximeter uses RF energy only
for its internal func tion. 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 fl oors 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
)for0.5
cycle
<40% U
T
(60% dip in U
T
)for5
cycles
<70% U
T
(30% dip in U
T
)for25
cycles
<5% U
T
(>95% dip in U
T
)for5s
N/A
N/A
Power frequency
(50Hz/60Hz)
magnetic field
3A/m 3A/m
Power frequency
magnetic fields should
be at levels
IEC61000‐4‐8 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
3Vrms
150 kHz to 80
MHz
3V/m
80 MHz to 2.5
GHz
N/A
3V/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
Interferenc e 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 sur vey 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
1N/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.
Copyright
This manual is written by our company and all rights reserved. Without our
company's prior written consent, no part of this manual may be reproduced or
copied in any form or method.
Illustration
All illustrations provided in this manual are for reference onl y, and the settings or
data in the illustrations may not be exactly the same as the actual display you see
on the product.
Shenzhen Viatom Technology Co., Ltd
4E, Building 3, Tingwei Industrial Park, No.6 Liufang Road, Block 67,
Xin'an Street, Baoan District, Shenzhen, 518101, Guangdong, China
www.viatomtech.com
MedNet EC‐REP GmbH
Borkstrasse 10, 48163 Muenster, Germany
Tel:[phone]‐0
Fax:[phone]‐22
Email:contact@mednet‐ecrep.com
MediMap Ltd
2 The Drift, Thurston, Suffolk IP31 3RT, United Kingdom
Tel:[phone]‐0
Fax:[phone]‐22
Email:contact@mednet‐ecrep.com
255‐04661‐00 A Jan. 2022
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
Charge the device.
No display Charge the device.
Record List
S： 98 99 98 97
P： 68 77 75 82
M1 M2 M3 M4