- A functional tester cannot be used to access the Note: 1.

Do not sterilize, autoclave or immerse this Operating Temperature: 5ºC~40ºC (41ºF ~
accuracy of a pulse oximeter monitor. device in liquid. Do not pour or spray any Condition 104ºF), Relative Humidity: 15-95%
(non condensing), Atmospheric
- Do not self-diagnose or self-medicate on the liquids onto the device. pressure: 700hPa ~ 1013hkPa, Model: SB100
basis of the measurements without consulting 2. Do not use caustic or abrasive cleaning Attitude: -1,280 to 12,000 feet
your doctor. In particular, do not start taking agents, or any cleaning agent containing (-390m to 3,658m)
any new medication or change the type and/or ammonium chloride or isopropyl alcohol. StorageCondition
Temperature: -25ºC~+70ºC(-
13ºF ~ 158ºF), Relative humidity:
dosage of any existing medication without prior 15-90%(non condensing),
approval. Troubleshooting Atmospheric pressure: 700hPa ~
1013hkPa, Attitude: -1,280 to 12,000
- Do not look directly inside the housing during Symptoms Check points Corrections feet (-390m to 3,658m)
the measurement. The red light and the invisible Place the finger Dimensions 63.5(L) × 34W) × 35(H) mm
infra-red light in the pulse oximeter are harmful Applied finger properly and try Weight About 37g (without the batteries)
improperly.
to your eyes. SpO2 or again. Standards IEC60601-1-2, Class B, IEC60601-1,
- This device is not intended for use by people pulse rate Try again; go to Type BF, ISO80601-2-61
cannot
SpO2 is too low to consult with your Type BF applied parts
(including children) with restricted physical, sen- displayed physician if you
sory or mental skills or a lack of experience and/ detect IP Classification IP22: Protection against harmful
are sure the de-
or a lack of knowledge, unless they are super- vice works well. ingress of water and particulate
matter
vised by a person who has responsibility for their SpO2 or Place the finger
Applied finger
safety or they receive instructions from this per- pulse rate properly and try EMC guidance and manufacturer’s declaration
improperly.
are not again. Recommended separation distances between portable and mobile RF communications equipment and the ME equipment
son on how to use the device. Children should displayed Finger is shaking or keep body
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 electromagnetic interference by main-
be supervised around the device to ensure they stably body is moving. steady
taining 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.
do not play with it. No display Batteries run down Replace with
Separation distance according to frequency of transmitter / m
Rated maximum output 150 kHz to 80 MHz , d=[3.5/ 80 MHz to 800 MHz , d=[3.5/ 800 MHz to 2,5 GHz , d=[3.5/
power of transmitter / W V1]√P E1]√P E1]√P
Fingertip Pulse Oximeter
- Neither of the displays for the pulse wave and when new batteries 0.01 0.12 0.12 0.23

pulse bar allows the strength of the pulse or button is

pressed
Batteries not in-
serted correctly.
Re-insert bat-
teries
0.1
1
10
0.37
1.17
3.7
0.37
1.17
3.7
0.74
2.33
7.37
www.rossmax.com
circulation to be evaluated at the measurement 100 11.67 11.67 23.33
The device will Declaration – electromagnetic emissions and immunity – for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING and
site. Rather, they are exclusively used to display auto power off
are specified for use only in a shielded location
The Finger-tip pulse oximeter declaration – electromagnetic immunity Warranty Card
the current signal variation at the measurement The display when it gets no Normal The Finger-tip pulse oximeter system is intended for use in the electromagnetic environment specified below. The customer
or the user of the Finger-tip pulse oximeter system should assure that it is used in such an environment. This instrument is covered by a 1 year guarantee from the date of purchase, batteries
disappears signal. Immunity test IEC 60601 test level Compliance level Electromagnetic environment-guidance
site and do not enable reliable diagnostics for suddenly Conducted RF 3 Vrms Portable and mobile RF communications equipment should be used and accessories are not included. The guarantee is valid only on presentation of the
IEC 61000-4-6 150 kHz to 80 MHz 3V
the pulse. Replace with no closer to any part of the EQUIPMENT or SYSTEM including cables,
guarantee card completed by the dealer confirming date of purchase or the receipt.
Low battery than the recommended separation distance calculated from the
Radiated RF 3 V/m new batteries equation applicable to the frequency of the transmitter. Interference
IEC 61000-4-3 80 MHz to 2.5 GHz 3V/m
may occur in the vicinity of equipment marked with the following
Opening or altering the instrument invalidates the guarantee. The guarantee does

Cleaning and disinfection Note: If the unit does not work, return it to
symbol.
Declaration – electromagnetic immunity
The Finger-tip pulse oximeter system is intended for use in the electromagnetic environment specified below. The customer
not cover damage, accidents or non-compliance with the instruction manual. Please
contact your local seller/dealer or www.rossmax.com.
1. Please clean the surface of the device before your dealer. Under no circumstance 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
Customer Name: ___________________________________
using. Wipe the device with medical alcohol should you disassemble and repair the Electrostatic ±6 kV contact ±6 kV contact Floors should be wood, concrete or ceramic
Address: ________________________________________
(70% isopropyl alcohol)first, and then let it dry unit by yourself. discharge (ESD)
IEC 61000-4-2
±8 kV air ±8 kV air tile. If floors are covered with synthetic
material, the relative humidity should be
Telephone: ______________________________________
at least 30 %.
in air or clean it by dry clean fabric. When clean- Electrical fast ±2 kV for power supply lines ±2 kV for power supply lines Mains power quality should be that E-mail address: ____________________________________
ing the device with water, the water tempera- Specification transient/burst IEC ±1 kV for input/output lines
61000-4-4
Surge IEC ± 1kV differential mode ± 1kV differential mode
of a typical commercial or hospital
environment.
Mains power quality should be that
Gender: Male Female Age: _____
ture should be lower than 60ºC SpO2
61000-4-5 ± 2kV common mode ± 2kV common mode of a typical commercial or hospital
environment.
Product Information: _______________________________
2. Using the medical alcohol to disinfect the prod- Measuring range 35%~99%, (the resolution is 1%).
Voltage dips, short <5% UT(>95% dip in UT) <5% UT(>95% dip in UT) Mains power quality should be that of a
interruptions and for 0,5 cycle for 0,5 cycle typical commercial or hospital environ- Date of purchase:__________________________________
voltage variations 40% UT(60% dip in UT) 40% UT(60% dip in UT) ment. If the user of the EQUIPMENT or
uct after use, prevent from cross infection for Accuracy 70%~99%: ±2%, Below 35~69%: on power supply for 5 cycles for 5 cycles SYSTEM requires continued operation Store where purchased: ______________________________
next time use. unspecified. input lines IEC
61000-4-11
70% UT(30% dip in UT) for 70% UT(30% dip in UT) for during power mains interruptions, it is
25 cycles 25 cycles recommended that the EQUIPMENT or
Optical Sensor Red light (wavelength is 660nm), <5% UT(>95% dip in <5% UT(>95% dip in SYSTEM be powered from an uninterrupt- WARNING: The symbol on this product means that it's an electronic product
3. The best storage environment of the device Infrared (wavelength is 905/880nm) Power frequency 3 A/m
UT) for 5 s UT) for 5 s
3 A/m
ible power supply or a battery.
Power frequency magnetic fields should
and following the European directive 2012/19/EU the electronic products have
to be dispose on your local recycling centre for safe treatment.
is - 20ºC to 70ºC ambient temperature and not Pulse
(50/60 Hz) mag-
netic field IEC
be at levels characteristic of a typical
location in a typical commercial or hospital
higher than 95% relative humidity. Measuring range 30bpm~250bpm (the resolution is
61000-4-8
Declaration – electromagnetic emissions
environment.

4. Users are advised to calibrate the device termly 1 bpm) The Finger-tip pulse oximeter is intended for use in the electromagnetic environment specified below. The customer or the user
of the Finger-tip pulse oximeter should assure that it is used in such an environment.

RI_IB_SB100_EN_SW_ver1708
(or according to the calibrating program of Accuracy ±3bpm Emission test Compliance Electromagnetic environment-guidance
CE emissions CISPR11 Group 1 The Finger-tip pulse oximeter uses RF energy only for its internal func-
Power source AAA × 2 (Alkaline) tion. Therefore, its RF emissions are very low and are not likely to cause
hospital). It also can be performed at the state-

IN0SB1000000000XX
any interference in nearby electronic equipment. Rossmax InnoTek Corp.
Battery life Continually for 16 hours with two RF emissions CISPR 11 Class B The Finger-tip pulse oximeter is suitable for use in all establishments,
appointed agent or just contact us for calibra- alkaline batteries
Harmonic emissions IEC 61000-3-2 Class A including domestic establishments and those directly connected to the
Voltage fluctuations/flicker emissions Complies public low-voltage power supply network that supplies buildings used
12F., No. 189, Kang Chien Rd., Taipei, 114,Taiwan.
Rossmax Swiss GmbH,
tion. IEC 61000-3-3 for domestic purposes.
Tramstrasse 16, CH-9442 Berneck, Switzerland
 Introduction - This device has no audible and it intended only
for spot-checking, but not medical result evalu-
Rossmax Fingertip Pulse Oximeter SB100 is used ation.
to measure arterial oxygen saturation (% SpO2) - This device is designed to determine the per-
of hemoglobin and pulse rate, an important centage of arterial oxygen saturation of func-
indicator of your respiratory function. It is non- tional hemoglobin. Factors that may degrade
invasive device intended for spot-check of adult pulse oximeter performance or affect the accu-
and pediatric whose age is over 3 at home, racy of the measurement include the following:
hospital and clinics. Attaching the lanyard • Do not apply the pulse oximeter on the same
Attention: Consult the accompanying 1. Insert the narrow end of the
 arm as a blood pressure cuff, arterial catheter or
documents. Please read this manual lanyard through the holder. infusion line(s)
carefully before use. Please be sure to keep 2. Draw the other end of the • Excessive light, such as sunlight or direct home
this manual. lanyard through the loop at lighting.
Name/ Functions of each part the narrow end and tighten. • Not steady at the site of application (e.g. trem-
bling)
• Moisture in the device
1 6 • Improperly applied device
How to use Note:
• Finger is too large or too small to fit into the
2 1. The SpO2 sensor and photoelectric receiving
1. Open the clip; press the Power On button as . device.
tube should be arranged in a way with the
2. Information of software version appears; insert • Poor pulse quality
subject’s arteriole in a position there between.
3 one finger, nail side up, into the finger opening • Venous pulsations
2. Make sure the optical path is free from any
4 of the pulse oximeter. • Anemia or low hemoglobin concentrations.
optical obstacles like rubberized fabric.
7 Note: if no finger insert, the device will auto shut • Cardiogreen and other intravascular dyes
3. Excessive ambient light may affect the measuring
5 off after 8 seconds. • Carboxyhemoglobin
result. It includes fluorescent lamp, dual ruby
3. The pulse strength indication shows “ ”, pulse • Methemoglobin
light, infrared heater, direct sunlight and etc.
oximeter begins its measurement as . • Dysfunctional hemoglobin
4. Strenuous action of the subject or extreme
Note: make sure the finger is lying flat, Do not shake • Artificial nails or fingernail polish
1. SpO2 icon 4. Beats per minute electrosurgical interference may also affect the
and keep body steady during measurement • On fingers with anatomical changes, oedemas,
2. Pulse strength 5. Power On Button accuracy.
as . scars or burns.
indication 6. Battery icon
4. Your SpO2 and pulse rate values will appear on - Using the device for long periods may cause
3. Pulse rate icon 7. Battery compartment
the screen after few seconds as .
Error code for your reference pain for people with circulatory disorders. Repo-
Note: 1.  Don’t remove your finger until the SENSOR ERROR: sition the device at least once every 4 hours to
Installing Batteries measurement is completed. Sensor cannot be de- allow the patient’s skin to breath and to check
1. Use thumb to slide battery cover out tected, return the device
2. If SpO2 and pulse rate cannot be detected,“ patient’s condition regularly.
2. Insert or replace 2 “AAA” sized batteries down to your local distributor or
“ will appear on the screen as . service centre. - Do not use the device near flammable or explo-
with the correct electrical polarity. 3. While pulse strength is low, the reading sive gas mixtures.
You need to replace the batteries when will flicker. - Do not use the device during an MRI or CT scan.
MEASURE ERROR:
1. Battery icon is blinking on display. - The device may not work when circulation is
2. The function button is pressed and nothing Signals cannot be detect-
ed, turn the device off and reduced. Warm or rub the finger, or re-position
appears on display. the device.
measure again.
Caution: Batteries may leak or explode if used - This device is a precision electronic instrument
or disposed of improperly. Remove and must be repaired by qualified technical pro-
batteries if the device will be stored for fessionals. Field repair of the device is not pos-
long time. Do not use different types Cautionary Notes sible. Do no attempt to open the case or repair
or brands of batteries at the same time. the electronics. Opening the case may damage
- This device is to be operated by trained person-
Do not mix fully charged and partially the device and void the warranty.
nel only.
charged batteries at the same time. - Do not overextend the device’s spring.