Cleaning
Maintenance
Troubleshooting
Specification
1. Please clean the surface of the device before using.
Wipe the device with medical alcohol (70% isopro-
pyl 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.
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.
Recommends user to return this device to the man-
ufacturer 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 ver-
ify operation of the pulse oximeter equipment.
Symptoms Check points Corrections
SpO2 or pulse
rate cannot
displayed
Applied nger
improperly.
Place the nger prop-
erly and try again.
SpO2 is too low to
detect
Try again; go to consult
with your physician if
you are sure the device
works well.
SpO2 or pulse
rate are not dis-
played stably
Applied nger
improperly.
Place the nger prop-
erly 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
SpO
2
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 30 bpm~250 bpm (the resolution is 1 bpm)
Accuracy ±3 bpm
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) × 34(W) × 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
Attention
Serial number
Manufacturer
Date of manufacture
Authorized representative in the European
Community
Note:
- A description of the effect on displayed and transmitted
SpO2 and pulse rate:
- Data averaging: 4 seconds for SpO2; 8 seconds for pulse
rate.
- Data update delay: Less than 2 seconds.
- The oximeter is calibrated in the factory before sale.
There is no need to calibrate during its life cycle.
Note: If the unit does not work, return it to your
dealer. Under no circumstance should you
disassemble and repair the unit by yourself.
Model: SB220
www.rossmax.com
Fingertip Pulse Oximeter
Rossmax InnoTek Corp.
12F., No. 189, Kang Chien Rd., Taipei,
114, Taiwan.
CMC Medical Devices & Drugs S.L.
C/ Horacio Lengo Nº 18, CP 29006,
Málaga, Spain
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.
IN0SB221000000013
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:
______________________________________________
RI_IB_SB220_EN_
2Yr_TP_ver2128
Note:
1. The product is with a service life of 5 years in the course
of regular use.
2. If any serious incident (e.g. death) has occurred in
relation to the device should be reported to the
dealer, manufacturer, and the competent authority of
the Member State in which the user and/or patient is
established.
3. The text is subject to change without further notice.
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 controlled. The customer or the user of the Finger-tip pulse oximeter can help prevent elec-
tromagnetic interference by maintaining a minimum distance between portable and mobile RF communi-
cations 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 transmitter / 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 interrup-
tions 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 EQUIP-
MENT 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 location in a typical com-
mercial 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 function. 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 emis-
sions IEC 61000-3-3
Complies
