• P oor pulse quality
• V enous pulsations
• Anemia or low hemoglobin concentrations.
• Cardiogr een and other intravascular dyes
• Carboxyhemoglobin
• Methemoglobin
• Dysfunc tional hemoglobin
• Ar tificial nails or fingernail polish
• On fingers with anatomical changes, oedemas , scars or burns.
- Using the device for long periods may cause pain f or people
with circulatory disorders. Reposition the device at least once
ever y 4 hours to allow the patient’ s skin to breath and to check
patient ’ s condition regularly .
- Do not use the device near flammable or explosive gas mixtures.
- D o not use the device during an MRI or C T scan, be used no
closer than 30 cm (12 inches) to any part of the SpO2 device,
including cables specified by the manufacturer .
- The device may not work when circulation is r educed. Warm or
rub the finger , or re -position the device.
- This device is a precision electronic instrument and must be
repaired b y qualified technical prof essionals. F ield repair of the
device is not possible. Do no attempt to open the case or repair
the electronics. Opening the case may damage the device and
void the warranty.
- Do not overextend the device ’ s spring.
- A functional tester cannot be used to access the accuracy of a
pulse oximeter monitor .
- Do not self- diagnose or self-medicate on the basis of the
measurements without consulting your doctor . In par ticular , do
not star t taking any new medication or change the type and/
or dosage of any existing medication without prior approval .
- Do not look directly inside the housing during the measurement.
The red light and the in visible infra-red light in the pulse
oximeter ar e harmful to your eyes.
- This device is not intended for use b y people (including
children) with restricted physical , sensory or mental sk ills or a
lack of experience and/or a lack of k nowledge, unless they are
super vised by a person who has responsibility for their saf et y
or they receive instructions from this person on how t o use the
device. Children should be supervised around the device to
ensure they do not play with it.
- Neither of the displays for the pulse wave and pulse bar allo ws
the strength of the pulse or circulation t o be evaluated at the
measurement site . Rather , they are exclusiv ely used to display
the current signal variation at the measurement site and do not
enable reliable diagnostics f or the pulse.
- The maximum temperature of sensors which the user will t ouch
might reach 43°C when operating in the 40°C envir onment.
- The safety for user use in high-t emperature envir onment is
measuring for 10 minutes , and turn it off for 20 minutes bef ore
measure again.
- The oximeter is calibrated in the factory before sale. There is no
need to calibrate during its life cycle.
Cleaning Troubleshooting Specification 1. P lease clean the sur face of the device before using . Wipe
the device with medical alcohol (70% isopropyl alcohol)
first, and then let it dr y in air or clean it by dr y clean fabric.
When cleaning the device with water , the water temperature
should be lower than 60°C
2. Using the medical alcohol to disinfect the pr oduct after use,
prevent fr om cross inf ection for next time use.
3. The best storage environment of the device is -25°C to 70°C
ambient temperature and not higher than 90% r elative
humidity.
Symptoms Check points Corrections
SpO
2
or pulse
rate cannot
displayed
Applied nger
improperly .
Place the nger
properly and tr y again.
SpO
2
is too low to
detect
T r y again; go to
consult with your
physician if you ar e
sure the device works
well.
SpO
2
or pulse
rate are not
displayed stably
Applied nger
improperly .
Place the nger
properly and tr y again.
F inger is shaking or
body is moving.
keep body steady
No display
when button is
pressed
Batteries run down
Replace with new
batteries
Batteries not
inser ted correctly .
Re -inser t batteries
The display
disappears
suddenly
The device will auto
power o when it
gets no signal.
Normal
Low batt er y
Replace with new
batteries
Note: If the unit does not work, return it to your dealer .
Under no circumstance should you disassemble and
repair the unit by yourself .
SpO2
Measuring range 35%~99%, (the resolution is 1%).
Accuracy 70%~99%: ±2%, Below 35~69%: unspecied.
Optical Sensor The wavelength of r ed LED is 660 nm and
Infrared LED is 905/880 nm with maximum
optical output power of 4 mW/sr .
Pulse
Measuring range 30bpm~250bpm (the resolution is 1 bpm)
Accuracy ±3bpm
Po wer source AAA × 2 (Alkaline)
Battery life Continually for 16 hours with two alkaline
batteries
Operating
Condition
T emperature: 5°C~40°C (41°F ~ 104°F),
Relative Humidity : 15-95% (non condensing),
Atmospheric pressure: 700hP a ~ 1060hPa,
Attitude: -1,280 to 12,000 feet (-390m t o
3,658m)
Storage /
T ranspor tation
Condition
T emperature: -25°C~+70°C (-13°F ~ 158°F),
Relative humidity : 15-90%(non condensing),
Atmospheric pressure: 700hP a ~ 1060hPa,
Attitude: -1,280 to 12,000 feet (-390m t o
3,658m)
Dimensions 63.5(L) × 34W ) × 35(H) mm
Weight About 37g (without the batteries)
Standards IEC60601-1-2, Class B, IEC60601-1, T ype BF ,
ISO80601-2-61, IEC60601-1-11
T ype BF applied parts
IP Classication IP22: Pr otection against harmful ingress of
water and particulate matter
Note: 1. Do not sterilize, autoclav e or immerse this device in
liquid. Do not pour or spray any liquids ont o the device.
2. Do not use caustic or abrasive cleaning agents, or
any cleaning agent containing ammonium chloride or
isopropyl alcohol .
Maintenance Recommends user to return this device to the manufacturer
per form the following checks ev er y 24 months.
- Inspect the equipment for mechanical and functional damage
or deterioration.
- Ensure all user inter face keys and accessories func tion normally.
Note: Manufacturer use Index2 SpO2 simulator to verify
operation of the pulse oximeter equipment.
Model: SB210 www.rossmax.com W ARNING: The symbol on this product means that it's an
electronic product and following the Eur opean directive
2012/19/EU the electronic products have to be dispose on
your local recycling centre f or safe tr eatment.
EMC guidance and manufacturer’s declaration
Recommended separation distances between portable and mobile RF communications equipment and the ME equipmen t
The Finger-tip pulse o ximeter is int ended for use in an electromagnetic envir onment in which radiat ed RF disturbances are c on-
trolled. The customer or the user of the F inger-tip pulse oximeter can help pr event electromagnetic interference by main taining
a minimum distance between portable and mobile RF communications equipment (transmitters) and the F inger-tip pulse
oximeter as r ecommended below , according to the maximum output pow er of the communications equipmen t.
Rated maximum output
power of transmit-
ter / W
Separation distance acc ording to fr equenc y of transmitter / m
150 kHz to 80 MHz , d=[3.5/
V1]√P
80 MHz to 800 MHz , d=[3.5/
E1]√P
800 MHz to 2,5 GHz , d=[3.5/
E1]√P
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.7 3.7 7.37
100 11.67 11.67 23.33
Declaration – electromagnetic emissions and immunity – for EQUIPMENT and SYSTEMS that ar e not LIFE-SUPPORTING and
are specied for use only in a shielded loca tion
The Finger-tip pulse o ximeter declara tion – electromagnetic immunity
The Finger-tip pulse o ximeter system is in tended for use in the electromagnetic envir onment specied below. The customer or
the user of the Finger-tip pulse oximet er system should assure tha t it is used in such an environmen t.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment-guidance
Conducted RF
IEC 61000-4-6
3 V rms
150 kHz to 80 MHz
3V
Portable and mobile RF communications equipment should be used
no closer to any part of the EQUIPMENT or SYSTEM including cables,
than the recommended separ ation distance calculat ed from the
equation applicable to the fr equency of the transmitter . Interference
may occur in the vicinity of equipment marked with the following
symbol.
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3V/m
Declaration – electromagnetic immunity
The Finger-tip pulse o ximeter system is in tended for use in the electromagnetic envir onment specied below. The customer or
the user of the Finger-tip pulse oximet er system should assure tha t it is used in such an environmen t.
Immunity test IEC 60601 test level Compliance lev el Electr omagnetic environmen t-guidance
Electrostatic
discharge (ESD) IEC
61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood , concret e or ceramic
tile. If oors are c over ed with synthetic
material , the relativ e humidity should be
at least 30 %.
Electrical fast
transient/burst IEC
61000-4-4
±2 kV for power sup-
ply lines
±1 kV for input/output
lines
±2 kV for power sup-
ply lines
Mains power quality should be that of a
typical commercial or hospital envir onment.
Surge IEC 61000-4-5 ± 1kV dierential mode
± 2kV common mode
± 1kV dierential mode
± 2kV common mode
Mains power quality should be that of a
typical commercial or hospital envir onment.
V oltage dips, short
interruptions and
voltage variations on
power supply input
lines IEC 61000-4-11
<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
<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
Mains power quality should be that of a
typical commercial or hospital envir onment.
If the user of the EQUIPMENT or SYSTEM
requir es continued opera tion during power
mains interruptions , it is recommended tha t
the EQUIPMENT or SYSTEM be power ed
from an unint erruptible power supply or
a battery .
Pow er frequency
(50/60 Hz) magnetic
eld IEC 61000-4-8
3 A/m 3 A/m Pow er frequency magnetic elds should
be at levels characteristic of a typical loca-
tion in a typical commercial or hospital
environmen t.
Declaration – electromagnetic emissions
The Finger-tip pulse o ximeter is int ended for use in the electromagnetic envir onment specied below . T he customer or the user
of the Finger-tip pulse oximet er should assure that it is used in such an en vironment .
Emission test Compliance Electromagnetic envir onment- guidance
CE emissions CISPR11 Group 1 The Finger-tip pulse oximeter uses RF ener gy only for its int ernal func-
tion. Ther efore, its RF emissions are very low and are not lik ely to cause
any interference in nearb y electronic equipment.
RF emissions CISPR 11 Class B The Finger-tip pulse o ximeter is suitable for use in all establishments ,
including domestic establishments and those directly connected t o the
public low-voltage pow er supply network that supplies buildings used
for domestic purposes.
Harmonic emissions IEC 61000-3-2 Class A
V oltage uctuations/icker emissions
IEC 61000-3-3
Complies
Rossmax Inno T ek Cor p .
12F ., No. 189, Kang Chien Rd ., T aipei, 114, T aiwan.
CMC Medical Devices & Drugs S.L.
C/ Horacio L engo N° 18, CP 29006, Málaga, Spain
Fingertip Pulse Oximeter - The Bluetooth ® w ord mark and logos ar e reg ister ed trademarks owned by the Bluetooth SIG, Inc . and any use of
such marks by Rossmax Interna tional Ltd . is under license. Other trademarks and tr ade names are those of their
respective owners .
- The P ulse Oximeter uses Bluetooth®( Bluetooth ® low ener gy technology)
- Apple and the Apple logo are trademarks of Apple Inc., r egistered in the U .S. and other countries . App Store is a
service mark of Apple Inc.
- Google Play and the Google Play logo are trademarks of Google Inc.
IN0SB210000000022
RI_IB_SB210_EN_
2Yr_TP_v er2122
W arranty Card
This instrument is cover ed by a 2 year guarantee fr om the date of
purchase, batteries and accessories are not included . The guarantee
is valid only on presentation of the guarantee car d completed by
the dealer confirming date of purchase or the receipt. Opening or
altering the instrument invalidates the guarantee . The guarantee
does not cover damage, accidents or non-compliance with the
instruction manual. Please contact your local seller/dealer or www.
rossmax.com.
Customer Name: ____________________________________
Address: ___________________________________________
T elephone: _________________________________________
E-mail address: ______________________________________
Product Information: ________________________________
Date of purchase: ____________________________________
Store where pur chased:
____________________________________________________
Note: - The product is with a ser vice life of 5 years in the
course of regular use.
- The text is subjec t to change without further notice.
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