•
•
•
•
•
•
•
•
•
•
-
with
ever
patient
- not use the device near flammable or explosive gas
mixtures.
-
-
rub the finger
-
repaired by qualified t
device
the
void the warranty
-
-
pulse oximeter
- not self- or self-medicate on the basis of the
measurements
not
or dosage of an
- not look directly inside the housing during the
measurement. The red
the pulse oximet
- device is not intended for use by people (including
children)
lack of exper
super
or
device. Children be super around the device to
ensure they do
-
the
measurement site.
the variation at the measurement do
not enable r
-
might reach
Cleaning
T
Specification
1. clean the sur of the device before using.
the device with medical alcohol (70% isopropyl alcohol)
first,
When
should be lower than 60°C
2.
prevent fr
3.
ambient temperature and not higher than 90% relative
humidity.
Symptoms Check points Corrections
SpO2 or pulse
rate cannot
displayed
Applied nger
improperly
Place the nger
properly and tr
SpO2 is too low to
detect
T
consult with your
physician if you ar
sure the device works
well.
SpO2 or pulse
rate are not
displayed stably
Applied nger
improperly
Place the nger
properly and tr
F
body is moving. keep body steady
No display
when button is
pressed
Batteries run down Replace with new
batteries
Batteries not
inser Re
The display
disappears
suddenly
The device will auto
power o when it
gets no signal.
Normal
Low batt Replace with new
batteries
Note: the unit does not work, return it to your dealer
Under
repair the unit by yourself
SpO2
Measuring range 35%~99%,
Accuracy 70%~99%: ±2%,
Optical Sensor Red light
(wavelength
Pulse
Measuring range 30bpm~250bpm
Accuracy ±3bpm
Po AAA ×
Battery life Continually f
batteries
Operating
Condition
T
Relative Humidity: 15-95% (non
Atmospheric pr
Attitude: -1,280
3,658m)
Storage /
T
Condition
T
Relative humidity: 15-90%(non condensing),
Atmospheric pr
Attitude: -1,280
3,658m)
Dimensions 63.5(L) ×
Weight About 37g
Standards IEC60601-1-2, Class B,
ISO80601-2-61, IEC60601-1-11
T
IP Classication IP22: P
water and
Note: 1. not sterilize, autoclave or immerse this de in
liquid.
2. not use caustic or abrasive cleaning agents, or
any cleaning agent
isopropyl alcohol
Maintenance
Recommends user to return this device to the manufacturer
per
-
or deterioration.
-
Model: SB210
w
W The symbol on this pr
electronic product and following the European directive
2012/19/EU the
your local recycling centre f
EMC guidance and manufacturer’s declaration
Recommended separation distances between portable and mobile RF communications equipment and the ME equipmen
The Finger-tip pulse o
trolled.
a minimum distance between portable and mobile RF communications equipment (transmitters) and the F
oximeter as r
Rated maximum output
power of transmit-
ter
Separation distance acc
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
are specied for use only in a shielded loca
The Finger-tip pulse o
The Finger-tip pulse o
the user of the Finger-tip pulse oximet
Immunity test IEC 60601 test level Compliance level Electromagnetic environment-guidance
Conducted RF
IEC 61000-4-6 3 V
150 kHz to 80 MHz 3V Portable and mobile RF communications equipmen
no closer to any part of the EQUIPMENT or SYSTEM including cables,
than the recommended separ
equation applicable to the fr
may occur in the vicinity of equipment marked with the follo
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
the user of the Finger-tip pulse oximet
Immunity test IEC 60601 test level Compliance lev 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
tile. If oors are c
material
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
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
V
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
If the user of the EQUIPMENT or SYSTEM
requir
mains interruptions
the EQUIPMENT or SYSTEM be power
from an unint
a battery
Pow
(50/60 Hz) magnetic
eld IEC 61000-4-8
3 A/m 3 A/m Pow
be at levels characteristic of a typical loca-
tion in a typical commercial or hospital
environmen
Declaration – electromagnetic emissions
The Finger-tip pulse o
of the Finger-tip pulse oximet
Emission test Compliance Electromagnetic envir
CE emissions CISPR11 Group 1 The Finger-tip pulse o
tion.
any interference in nearb
RF emissions CISPR 11 Class B T
including domestic establishments and those directly connected t
public low-voltage pow
for domestic purposes.
Harmonic emissions IEC 61000-3-2 Class A
V
IEC 61000-3-3 Complies
Rossmax Inno
12F
CMC Medical Devices & Drugs S.L.
C/ Horacio L
Fingertip Pulse Oximeter
- Bluetooth ® word mark and logos are r
such marks by Rossmax Interna
respective owners
- Bluetooth ®(Bluetooth ® low energy t
-
service mark of Apple Inc.
-
IN0SB210000000021
RI_IB_SB210_EN_2Yr_
TP_ver2003
W
This
purchase,
is
the
altering the invalidates the
does not cover damage accidents or non- with the
instruction manual. Please contact your local
rossmax.com.
Customer Name: ____________________________________
Address: ___________________________________________
T _________________________________________
E-mail address: ______________________________________
Product Information: ________________________________
Date of purchase: ____________________________________
Store where pur
____________________________________________________
RI_IB_SB210_EN_2Yr_TP_ver2003.indd 1 2020/8/27 下午 01:51:04
