SB100 Fingertip Pulse Oximeter
Instruction for Use
1. Safety information
WARNING: The SpO2 device is to be operated
by trained personnel only.
WARNING: Do not use the SpO2 device in the
presence o lammable anesthetics to prevent
explosion hazard.
WARNING: Do not use the SpO2 device in the
Magnetic Resonance Imaging (MRI) ambience.
WARNING: The SpO2 readings and pulse
signals can be a ected by the conditions o ambience
and patient.
WARNING: Do not open up the SpO2 device
except or the battery cover. The SpO2 device is
without any user-serviceable part inside and only
quali ied service personnel can per orm maintenance
service.
WARNING: Do not expose the SpO2 device to
extreme moisture (such as rain) to ensure accurate
per ormance and device sa ety.
WARNING: I the accuracy o measurement by
the SpO2 device is uncertain, check the patient’s vital
signs by alternate means.
Warning: This device is intended only as an
adjunct in patient assessment. It must be used in
conjunction with clinical signs and symptoms.
WARNING: Reposition the device at least once
every 4 hours to allow the patient’s skin to breath.
WARNING: The SpO2 device is not intended or
the use o neonatal.
WARNING: Do not use the SpO2 device with
other devices (such as, the cu o blood pressure
monitor) that may inter ere with blood low and cause
inaccurate measurement.
Warning: The SpO2 device will be a ected by
electromagnetic inter erence during operation.
Warning: Please remove the batteries rom the
battery compartment i the device will not be used or
a long period o time.
2.
Introduction
The Fingertip pulse oximeter is to spot-check oxygen
saturation in blood (SpO2) and pulse rate. The pulse
oximeter is used on adults and pediatric whose age is
over 3 at hospital, clinics, and/or home.
The device contains a dual light source (Red LED and
In rared red LED) and a photodetector. Bone, tissue,
pigmentation, and venous vessels normally absorb a
constant amount o light over time. The arteriolar bed
normally pulsates and absorbs variable amounts o
light during the pulsations. The ratio o light absorbed
is translated in an oxygen saturation measurement
(SpO2). Because a measurement o SpO2 is dependent
on light rom the device, excessive ambient light can
inter ere with this measurement.
The wavelength o red LED is 660nm and In rared
LED is 905/880nm with maximum optical output
power o 4mW.
There is no visual or audio alarm.
3. Features
Measure and display reliable SpO2 value and heart
rate.
Single turn-on key or easy operation.
Bright LED display.
Light, compact, and portable.
Battery power is or a continuing use o 16 hours.
Two AAA Alkaline batteries or power supply.
Device will be o automatically a ter 8 seconds in
idling.
. Product introduction
Top View Bottom View
1
% SpO2 signal 5
Power On/O Button
2
Pulse strength 6
Battery compartment
3
Pulse rate 7
SpO2 icon
4
Beats per minute 8
Battery indicator
5. Operation
Open up battery compartment cover care ully and then
install two “AAA” Alkaline batteries according to the
(+/-) polarity.
Press the “power switch” key or 1 second to activate
the device. All icons appear on the LED screen. The
device is then in the “sel -test” mode with the so tware
version shown.The measurement starts at the
completion o the “sel -test.”
The pulse bar with “-“ icon on the screen up and down
means the measurement result will be ready soon.
The readings o oxygen saturation, pulse rate, and
pulse strength will appear on LED screen in 8 seconds
average. I the measurement ails, the icon “- -“ will
appear on LED screen. Reading lashing while SpO2
is low.
D
isplay “Er” signal while LED or sensor is
mal unctioning.
The device will turn itsel o automatically a ter
8-second idling.
While the battery power is low, the LED icon will
appear. Please replace the batteries as soon as possible
or the device will be o automatically in 30 seconds.
6. Specifications
6.1 Performance
Scope o measurement: SpO2: 35% - 99%
Pulse rate: 30-250 bpm (beats per minute)
Precision: SpO2: 70%-99% : ±2%,
35% - 69%: unspeci ied
Pulse rate: 30-250 ± 3 bpm
6.2 Electrical specifications
Battery (2 “AAA” Alkaline batteries)
Battery capability: Can be used or 16 hours
continuously depending on the type o battery used
.
6.3 Environmental conditions
Operating temperature 5℃ - 40℃ (41℉ – 104℉)
Storage temperature: -20℃ - 70℃ (-4℉ – 158℉)
Relative humidity: 15% -95% (no condensing)
Attitude: -1,280 to 12,000 eet(-390m to 3,658m)
Atmospheric Pressure: 700 hPa to 1060 hPa (hPa)
6. Physical characteristics
Weight: 37g (excluding battery)
Size: 63.5 x 34 x 35 mm
6.5 Standards
IEC60601-1-2,Class B,IEC60601-1,Type BF,ISO9919
6.6 Markings
Type BF (Body Floating)
Drip proo
Date o manu acture
CONSULT INSTRUCTIONS FOR USE
ATTENTION
Used batteries should not be disposed o
in the household rubbish. Batteries
should be deposited at a collection point
or used batteries. At the end o its li e,
the appliance should not be disposed o
in household rubbish. Enquire about the
options or environment- riendly and
appropriate disposal. Take into account
local regulations.
Alarm unction is o
Complies with the European Medical
Device Directive 93/42/EEC
7.
Problem shooting and maintenance
7.1 Dysfunction and resolution
Low battery-Please replace the battery
Switch On ailure-
Check the power o battery
Check the placement o battery
Return to manu acturer or calibration
7.2 Cleaning
Sur ace cleanings is by using a so t cloth dampened
with either a commercial, non-abrasive cleaner or a
solution o 70% isopropyl alcohol in water, and lightly
wiping the sur aces o the oximeter.
Please switch o pulse oximeter be ore cleaning.
Clean the LED and photo-sensor with moist cloth or
cotton ball and alcohol gently.
The a orementioned general cleaning process is not
or in ection prevention. Please contact the specialist
or the process o contagious in ection.
7.3 Disposal
Used batteries should not be disposed o in the
household rubbish. Batteries should be deposited at a
collection point or used batteries.
At the end o its li e, the appliance should not be
disposed o in household rubbish. Enquire about the
options or environment- riendly and appropriate
disposal. Take into account local regulations.
7. Electromagnetic interference
Caution: This device has been tested and ound to
comply with the limits or medical devices to the IEC
60601-1-2 and MDD 93/42/EEC. These limits are
designed to provide reasonable protection against
harm ul inter erence in a typical medical installation.
However, because o the proli eration o
radio- requency transmitting equipment and other
sources o electrical noise in healthcare environments
( or example, electrosurgical units, cellular phones,
mobile two-way radios, electrical appliances, and
high-de inition television), it is possible that high
levels o such inter erence due to close proximity or
strength o a source may result in disruption o
per ormance o this device.
This Fingertip pulse oximeter is not designed or use
in environments in which the pulse can be obscured by
electromagnetic inter erence. During such
inter erence, measurements may seem inappropriate or
the monitor may not seem to operate correctly.
8. Warranty
The company warrants pulse oximeter at the time o
its original purchase and or the subsequence time
period o one year.
The warranty does not cover the ollowings:
The device series number label is torn o or
cannot be recognized.
Damage to the device resulting rom
misconnection with other devices.
Damage to the device resulting rom accidents.
Changes per ormed by users without the prior
written authorization o the company.
Rossmax InnoTek Corp.
12F, No. 189, Kang Chien Rd., Taipei 114, Taiwan
Tel: + 886-2-2659-7888
Fax: + 886-2-2659-7666
www.rossmax.com
The text is subject to change without urther notice.
Version 20 , September 21, 2015
IBP innovative business promotion GmbH
Botzstrasse 6, D-07743 Jena, Germany
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