- Do 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 SpO
2
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 invisible infra-r ed light in
the pulse oximeter are harmful to y our eyes.
- This device is not intended for use b y people (including
children) with restricted physical , sensor y or mental skills 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 ety
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 f or the pulse wave and pulse bar allows
the strength of the pulse or circulation t o be evaluated at the
measurement site . Rather, they ar e exclusively used to displa y
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 f or 20 minutes befor e
measure again.
- The oximeter is calibrated in the factory before sale. There is no
need to calibrate during its life cycle.
Cleaning Maintenance Troubleshooting Specification 1. Please clean the surface of the de vice befor e 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 product after use,
prevent fr om cross infection for next time use.
3. The best storage envir onment of the device is - 25°C to
70°C ambient temperature and not higher than 90% r elative
humidity.
Note: 1. Do not sterilize, autoclave 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 .
Recommends user to return this device to the manufacturer
per form the follo wing checks ever y 24 months.
- Inspec t the equipment for mechanical and functional damage
or deterioration.
- Ensure all user interface k eys and accessories function nor mally .
Note: M anufacturer 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 tr y again
SpO
2
is too low to
detect
T r y again; go to consult
with your physician if
you are sur e 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 shak ing 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 .
SpO
2
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 30 bpm~250 bpm (the resolution is 1 bpm)
Accuracy ±3 bpm
P ower 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 ~ 1060hP a, Attitude: -1,280 to
12,000 feet (-390m to 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 ~ 1060hP a, Attitude: -1,280 to
12,000 feet (-390m to 3,658m)
Dimensions 63.5(L) × 34( W ) × 35(H) mm
W eight 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 par ts
IP Classication IP22: Pr otection 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 f or S pO
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_v er2132
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 t o be
dispose on your local recycling centre f or safe treatment.
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 intended for use in an electromag netic environment in which radia ted RF disturbances are c on-
trolled. The customer or the user of the F inger-tip pulse oximeter can help pr event electromagnetic int erference by maintaining
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 equipment.
Rated maximum output
power of transmit-
ter / W
Separation distance acc ording to fr equency 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 declaration – electromagnetic immunity
The Finger-tip pulse o ximeter system is int ended for use in the electromagnetic environmen t specied below . The customer or
the user of the Finger-tip pulse oximet er system should assure that it is used in such an en vironment.
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 calculated fr om the
equation applicable to the fr equency of the transmitter . Interference
may occur in the vicinity of equipment marked with the follo wing
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 int ended for use in the electromagnetic environmen t specied below . The customer or
the user of the Finger-tip pulse oximet er system should assure that it is used in such an en vironment.
Immunity test IEC 60601 test level C ompliance level Electromagnetic envir onment- 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 c eramic
tile. If oors are c overed with syn thetic
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 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 operation during pow er
mains interruptions , it is recommended that
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 intended for use in the electromag netic environment specied below . The customer or the user
of the Finger-tip pulse oximet er should assure that it is used in such an envir onment.
Emission test Compliance Electromagnetic envir onment- guidance
CE emissions CISPR11 Group 1 The Finger-tip pulse o ximeter uses RF energy only for its internal func-
tion. Therefore, its RF emissions ar e ver y 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 Corp .
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 W arranty Card
This instrument is cover ed by a 2 year guarantee from the dat e 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:
1. The product is with a ser vice life of 5 years in the course of
regular use.
2. If any serious incident (e.g. death) has occurr ed in relation to
the device should be reported to the dealer , manufac turer ,
and the competent authority of the Member State in which
the user and/or patient is established.
3. The text is subjec t to change without further notice.
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