- 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 SpO
2
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
MaintenanceTroubleshooting
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.
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 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 SpO
2
simulator to verify
operation of the pulse oximeter equipment.
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.
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
Note:
- A description of the effect on displayed and transmitted SpO
2
and pulse rate:
- Data averaging: 4 seconds for SpO
2
; 8 seconds for pulse rate.
- Data update delay: Less than 2 seconds.
Model: SB200
www.rossmax.com
IN0SB200000000313
RI_IB_SB200(cont)_
EN_2Yr_TP_ver2132
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
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:
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.
