• Poor pulse quality
• Venous pulsations
• Anemia or low hemoglobin concentrations.
• Cardiogreen and other intravascular dyes
• Carboxyhemoglobin
• Methemoglobin
• Dysfunctional hemoglobin
• Artificial nails or fingernail polish
• On fingers with anatomical changes, oedemas, scars or burns.
- Using the device for long periods may cause pain for people
with circulatory disorders. Reposition the device at least once
every 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.
- Do not use the device during an MRI or CT 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 reduced. Warm or
rub the finger, or re-position the device.
- This device is a precision electronic instrument and must be
repaired by qualified technical professionals. Field 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 particular, do
not start 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 invisible infra-red light in the pulse
oximeter are harmful to your eyes.
- This device is not intended for use by people (including
children) with restricted physical, sensory or mental skills or a
lack of experience and/or a lack of knowledge, unless they are
supervised by a person who has responsibility for their safety
or they receive instructions from this person on how to 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 allows
the strength of the pulse or circulation to be evaluated at the
measurement site. Rather, they are exclusively used to display
the current signal variation at the measurement site and do not
enable reliable diagnostics for the pulse.
- The maximum temperature of sensors which the user will touch
might reach 43°C when operating in the 40°C environment.
- The safety for user use in high-temperature environment is
measuring for 10 minutes, and turn it off for 20 minutes before
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. Please clean the surface of the device before using. Wipe
the device with medical alcohol (70% isopropyl alcohol)
first, and then let it dry in air or clean it by dry 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 product after use,
prevent from cross infection 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% relative
humidity.
Symptoms Check points Corrections
SpO
2
or pulse
rate cannot
displayed
Applied nger
improperly.
Place the nger
properly and try again.
SpO
2
is too low to
detect
Try again; go to
consult with your
physician if you are
sure the device works
well.
SpO
2
or pulse
rate are not
displayed stably
Applied nger
improperly.
Place the nger
properly and try again.
Finger is shaking or
body is moving.
keep body steady
No display
when button is
pressed
Batteries run down
Replace with new
batteries
Batteries not
inserted correctly.
Re-insert batteries
The display
disappears
suddenly
The device will auto
power o when it
gets no signal.
Normal
Low battery
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 red 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
Power source AAA × 2 (Alkaline)
Battery life Continually for 16 hours with two alkaline
batteries
Operating
Condition
Temperature: 5°C~40°C (41°F ~ 104°F),
Relative Humidity: 15-95% (non condensing),
Atmospheric pressure: 700hPa ~ 1060hPa,
Attitude: -1,280 to 12,000 feet (-390m to
3,658m)
Storage /
Transportation
Condition
Temperature: -25°C~+70°C (-13°F ~ 158°F),
Relative humidity: 15-90%(non condensing),
Atmospheric pressure: 700hPa ~ 1060hPa,
Attitude: -1,280 to 12,000 feet (-390m to
3,658m)
Dimensions 63.5(L) × 34W) × 35(H) mm
Weight About 37g (without the batteries)
Standards IEC60601-1-2, Class B, IEC60601-1, Type BF,
ISO80601-2-61, IEC60601-1-11
Type BF applied parts
IP Classication IP22: Protection against harmful ingress of
water and particulate matter
Note: 1. Do not sterilize, autoclave or immerse this device in
liquid. Do not pour or spray any liquids onto 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
perform the following checks every 24 months.
- Inspect the equipment for mechanical and functional damage
or deterioration.
- Ensure all user interface keys and accessories function normally.
Note: Manufacturer use Index2 SpO2 simulator to verify
operation of the pulse oximeter equipment.
Model: SB210
www.rossmax.com
WARNING: The symbol on this product means that it's an
electronic product and following the European directive
2012/19/EU the electronic products have to be dispose on
your local recycling centre for safe treatment.
EMC guidance and manufacturer’s declaration
Recommended separation distances between portable and mobile RF communications equipment and the ME equipment
The Finger-tip pulse oximeter is intended for use in an electromagnetic environment in which radiated RF disturbances are con-
trolled. The customer or the user of the Finger-tip pulse oximeter can help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile RF communications equipment (transmitters) and the Finger-tip pulse
oximeter as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output
power of transmit-
ter / W
Separation distance according to frequency 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 are not LIFE-SUPPORTING and
are specied for use only in a shielded location
The Finger-tip pulse oximeter declaration – electromagnetic immunity
The Finger-tip pulse oximeter system is intended for use in the electromagnetic environment specied below. The customer or
the user of the Finger-tip pulse oximeter system should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment-guidance
Conducted RF
IEC 61000-4-6
3 Vrms
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 separation distance calculated from the
equation applicable to the frequency 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 oximeter system is intended for use in the electromagnetic environment specied below. The customer or
the user of the Finger-tip pulse oximeter system should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment-guidance
Electrostatic
discharge (ESD) IEC
61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete or ceramic
tile. If oors are covered with synthetic
material, the relative 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 environment.
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 environment.
Voltage 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 environment.
If the user of the EQUIPMENT or SYSTEM
requires continued operation during power
mains interruptions, it is recommended that
the EQUIPMENT or SYSTEM be powered
from an uninterruptible power supply or
a battery.
Power frequency
(50/60 Hz) magnetic
eld IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic elds should
be at levels characteristic of a typical loca-
tion in a typical commercial or hospital
environment.
Declaration – electromagnetic emissions
The Finger-tip pulse oximeter is intended for use in the electromagnetic environment specied below. The customer or the user
of the Finger-tip pulse oximeter should assure that it is used in such an environment.
Emission test Compliance Electromagnetic environment-guidance
CE emissions CISPR11 Group 1 The Finger-tip pulse 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 Finger-tip 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.
Harmonic emissions IEC 61000-3-2 Class A
Voltage uctuations/icker emissions
IEC 61000-3-3
Complies
Rossmax InnoTek Corp.
12F., No. 189, Kang Chien Rd., Taipei, 114, Taiwan.
CMC Medical Devices & Drugs S.L.
C/ Horacio Lengo N° 18, CP 29006, Málaga, Spain
Fingertip Pulse Oximeter
- The Bluetooth® word mark and logos are registered trademarks owned by the Bluetooth SIG, Inc. and any use of
such marks by Rossmax International Ltd. is under license. Other trademarks and trade names are those of their
respective owners.
- The Pulse Oximeter uses Bluetooth®(Bluetooth® low energy technology)
- Apple and the Apple logo are trademarks of Apple Inc., registered 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_ver2122
Warranty Card
This instrument is covered by a 2 year guarantee from the date of
purchase, batteries and accessories are not included. The guarantee
is valid only on presentation of the guarantee card 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: ___________________________________________
Telephone: _________________________________________
E-mail address: ______________________________________
Product Information: ________________________________
Date of purchase: ____________________________________
Store where purchased:
____________________________________________________
Note: - The product is with a service life of 5 years in the
course of regular use.
- The text is subject to change without further notice.
