Symbol Definition Symbol Definition Symbol Definition Symbol Definition
% SpO2 The Pu lse Ox yg en
Saturation (%) Serial Number Battery positive electrode BF type app lied part
PR Pulse RateBPMThe device has no Alarm
System Battery cath od e electrode Manufacturer
IPX2
The p roduct is protected
again st h armful effects of
drippin g water per IEC
60 52 9.
Date of Manufacturer Caution , consu lt
accompanying d ocu ments
This item is compliant with
Medical Device Directiv e
93 /42/EEC
/
Federal law restricts this device to sale by or o n the o rder of a
licensed h ealthcare practitioner
7 LED Wavelengths
Probe LED Specifications
Wavelength Radiant Power
RED 660±2nm 1.8m W
IR 906±10nm 2.0m W
Function FS10C FS20C
Display LED OLED
Spo2 parameter measurement Y Y
Pulse rate parameter measurement Y Y
Bar graph display Y Y
Battery display Y Y
Automatically enters sleep mode Y Y
Pulse waveform display —Y
Four direction display —Y
5 minutes.
FS10C FS20C
Display type LED Dual_color OLED, 0.96", 128×64 pixel
Display content SpO2%, Pulse rate, Battery indicator, Bar graph SpO2%, Pulse rate, Batter y indica tor, Bar gra ph ， Pulse
wav eform , Heart beat mark
FS10C/FS20C
is p
It's
designed
s
Figure2. Front View of FS10C Figure2. Front View of FS20C
FS10C)
Figure3. FS10C/20 C Battery Installation
+
-
+
-
EC REPRESENTATIVE
Shanghai Internatio nal Holding Corp. GmbH (E urope)
Add: Eiffestrasse 80, 20537 Hamburg，Germany
Tel: +49-40-2513175 Fax: +49-40-255726
Hunan Accurate Bio-Medical Technology Co., Ltd.
Add: 6th,Fl oor,Biyang Industrial Zone, Lijiacun Road,Xueshi Street of Yuelu District,
410208 Changsha,Hunan Prov ince,PEOPLE'S REPUBLIC OF CHINA
might be unreliable with the
4
The bar gra
TM
Shenzhen Viatom Technology Co., Ltd.
Add: 4E, Building 3, Tingwei Industrial Park, Honglang
North 2nd Road, Baoan, 518100 Shenzhen,
Guangdong, P.R.China
Website: www.viatomtech.com
Email: marketing@viatomtech.com
Tel: 86-755-86638929 Fax: 86-755-22649904
Pulse Oximeter
Tel/ Fax: +86 -731-84118539
0,01 / 0.02 0.03
0,1 / 0.06 0.11
1 / 0.18 0.35
10 / 0.57 1.1
100 / 1.8 3.5
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 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.
Rated maximum output
power of transmitter(W)
Separation distance according to frequency of transmitter(m)
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
Recommended separation distances between portable and mobile RF communications equipment
and the Medical FS10C/FS20C PULSE OXIMETER
The FS10C/FS20C Pulse Oximeter is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the Medical FS10C/FS20C PULSE OXIMETER can help prevent electromagnetic
interference by m aintaining a minimum distance between portable and mobile RF communications equipment (transmitters)
and the FS10C/FS20C Pulse Oximeter as recommended below, according to the maximum output power of the
communications equipment.
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
Portable and mobile RF communications equipment should be used no closer
to any part of the FS10C/FS2C Pulse Oximeter, including cables, than the
recommended separation distance calculated from 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 and d is the recommended
separation distance in metres (m).
Field strengths from fixed RF transmitters, as determined by an
electromagneti
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.
Compliance level
Radiated RF
IEC 61000-4-3
Guidance and manufacturer’s declaration – electromagnetic immunity
The FS10C/FS20C Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of the
FS10C/FS20C Pulse Oximeter should ensure that it is used in such an environment.
Immunity test IEC 60601 test level
N/A
3 V/m3 V/m
80 MHz to 2,5 GHz
80MHz to 800 MHz
800MHz to 2.5 GHz
Electromagnetic environment – guidance
Trouble Possible Reason Solution
The batteries are completely exhausted Please replace the batteries
An incorrect battery installation. Verify and correct the batteries installation
The oximeter breakdown Please contact local service
The batteries are completely exhausted Please replace batteries
The luminescent or photoelectric window is
sheltered by some object. Check the luminescent and photoelectric window.
Excessive movement Stop moving finger,hand and body
The finger is not placed inside deep enough. Place the finger properly and try again.
Finger size is not within the recommended range Change another finger
Excessive ambient light Avoid the excessive light
Pulse rate value of the cyclical fluctuations. The measurement is normal, and the patient is
arrhythmia.
The finger is not properly positioned Place the finger properly and try again.
The patient's SpO2 is too low to be detected Try again, Go to a hosptial for a diagnosis if you are
sure the device works all right
Press the button again to reactivate the oximeter
The device will turn into sleep mode automatically
if there is no signal in 8 seconds
The oximeter can't turn to
measure mode
The display is off suddenly.
The Spo2 and Pulse Rate
display unstable
The Spo2 and PR are not
displayed normally
Electrostatic
discharge (ESD)
IEC 61000-4-2
NOTE UT is the a.c. mains voltage prior to application of the test level.
Power frequency
(50/60 Hz)
magnetic field
Guidance and manufacturer”s declaration ‘ electromagnetic immunity
The FS10C/FS20C Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the
user of the FS10C/FS20C Pulse Oximeter should ensure that it is used in such an environment.
Immunity test
Floors should be wood, concrete or ceramic tile. If floors are
covered with synthetic material, the relative humidity should be at
least 30 %.
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
IEC 60601
test level
Compliance
level Electromagnetic environment ‘guidance
3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic
of a typical location in a typical commercial or hospital environment.
Emissions test Compliance
RF emissions
CISPR 11 Group 1
RF emissions
CISPR 11 Class B
Harmonic emissions
IEC 61000-3-2 N/A
Voltage fluctuations
flicker emissions
IEC 61000-3-3
N/A
The FS10C/FS20C Pulse Oximeter is suitable for use in all establishments, including
domestic establishments and those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic purposes.
Guidance and manufacturer ”s declaration ‘ electromagnetic emissions
The FS10C/FS20C Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the
user of the FS10C/FS20C Pulse Oximeter should ensure that it is used in such an environment.
Electromagnetic environment ẅ guidance
The FS10C/FS20C Pulse 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.
Bias Analysis
SpO2-FS20C
Pulse Oximeter 70 – 80 (%) 80 – 90 (%) 90 – 100 (%) 70 – 100 (%)
Mean Bias (Bs) 1.94 1.45 0.89 1.4
Precision (Sres) 2 1.55 0.98 1.53
Accuracy (Arms) 1.98 1.53 0.96 1.52
SaO2-Radiometer ABL800 FLEX-CO-Oximeter
7 Maintenance,Cleaning,Disinfection
8 Cleaning / Disinfection
One user manual
One certificate card
File Ver: A
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1
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