Rossmax SB100 Instructions For Use

SB100 Fingertip Pulse Oximeter
Instruction for Use
1. Safety information
WARNING: The SpO 2 device is to be operated
by trained personnel only.
WARNING: Do not use the SpO 2 device in the
presence of flammable anesthetics to prevent
explosion hazard.
WARNING: Do not use the SpO 2 device in the
Magnetic Resonance Imaging (MRI) ambience.
WARNING: The SpO 2 readings and pulse
signals can be affected by the conditions of ambience
and patient.
WARNING: Do not open up the SpO 2 device
except for the battery cover. The SpO 2 device is
without any user-serviceable part inside and only
qualified service personnel can perform maintenance
service.
WARNING: Do not expose the SpO 2 device to
extreme moisture (such as rain) to ensure accurate
performance and device safety.
WARNING: If the accuracy of measurement by
the SpO 2 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 SpO 2 device is not intended for
the use of neonatal.
WARNING: Do not use the SpO 2 device with
other devices (such as, the cuff of blood pressure
monitor) that may interfere with blood flow and cause
inaccurate measurement.
Warning: The SpO 2 device will be affected by
electromagnetic interference during operation.
Warning: Please remove the batteries from the
battery compartment if the device will not be used for
a long period of time.
Introduction
2.
The Fingertip pulse oximeter is to spot-check oxygen
saturation in blood (SpO 2 ) 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
Infrared red LED) and a photodetector. Bone, tissue,
pigmentation, and venous vessels normally absorb a
constant amount of light over time. The arteriolar bed
normally pulsates and absorbs variable amounts of
light during the pulsations. The ratio of light absorbed
is translated in an oxygen saturation measurement
(SpO 2 ). Because a measurement of SpO 2 is dependent
on light from the device, excessive ambient light can
interfere with this measurement.
The wavelength of red LED is 660nm and Infrared
LED is 905/880nm with maximum optical output
power of 4mW.
There is no visual or audio alarm.
3. Features
Measure and display reliable SpO 2 value and heart
rate.
Single turn-on key for easy operation.
Bright LED display.
Light, compact, and portable.
Battery power is for a continuing use of 16 hours.
Two AAA Alkaline batteries for power supply.
Device will be off automatically after 8 seconds in
idling.
4. Product introduction
Top View
1 8
7
2
3
4
6
5
1 % SpO 2 signal 5 Power On/Off Button
2 Pulse strength 6 Battery compartment
3 Pulse rate 7 SpO 2 icon
4 Beats per minute 8 Battery indicator
5. Operation
Open up battery compartment cover carefully and then
install two "AAA" Alkaline batteries according to the
(+/-) polarity.
Press the "power switch" key for 1 second to activate
the device. All icons appear on the LED screen. The
device is then in the "self-test" mode with the software
version shown.The measurement
completion of the "self-test."
The pulse bar with "-" icon on the screen up and down
means the measurement result will be ready soon.
The readings of oxygen saturation, pulse rate, and
pulse strength will appear on LED screen in 8 seconds
average. If the measurement fails, the icon "- -" will
appear on LED screen. Reading flashing while SpO2
D
is low. isplay "Er" signal while LED or sensor is
malfunctioning.
The device will turn itself off automatically after
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 off automatically in 30 seconds.
6. Specifications
6.1 Performance
Scope of measurement: SpO 2 : 35% - 99%
Pulse rate: 30-250 bpm (beats per minute)
Precision: SpO 2 : 70%-99% : ±2%,
35% - 69%: unspecified
Pulse rate: 30-250 ± 3 bpm
6.2 Electrical specifications
Battery (2 "AAA" Alkaline batteries)
Battery capability: Can be used for 16 hours
continuously depending on the type of 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 feet(-390m to 3,658m)
Atmospheric Pressure: 700 hPa to 1060 hPa (hPa)
6.4 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 proof
Date of manufacture
CONSULT INSTRUCTIONS FOR USE
ATTENTION
Used batteries should not be disposed of
in the household rubbish. Batteries
should be deposited at a collection point
for used batteries. At the end of its life,
the appliance should not be disposed of
in household rubbish. Enquire about the
options for environment-friendly and
appropriate disposal. Take into account
local regulations.
Alarm function is off
Complies with the European Medical
Device Directive 93/42/EEC
7.
Problem shooting and maintenance
Bottom View
7.1 Dysfunction and resolution
Low battery-Please replace the battery
Switch On failure-
Check the power of battery
Check the placement of battery
Return to manufacturer for calibration
7.2 Cleaning
Surface cleanings is by using a soft cloth dampened
with either a commercial, non-abrasive cleaner or a
solution of 70% isopropyl alcohol in water, and lightly
wiping the surfaces of the oximeter.
Please switch off pulse oximeter before cleaning.
Clean the LED and photo-sensor with moist cloth or
cotton ball and alcohol gently.
The aforementioned general cleaning process is not
for infection prevention. Please contact the specialist
for the process of contagious infection.
7.3 Disposal
Used batteries should not be disposed of in the
household rubbish. Batteries should be deposited at a
collection point for used batteries.
At the end of its life, the appliance should not be
disposed of in household rubbish. Enquire about the
starts at the
options for environment-friendly and appropriate
disposal. Take into account local regulations.
7.4 Electromagnetic interference
Caution: This device has been tested and found to
comply with the limits for medical devices to the IEC
60601-1-2 and MDD 93/42/EEC. These limits are
designed to provide reasonable protection against
harmful interference in a typical medical installation.
However,
radio-frequency transmitting equipment and other
sources of electrical noise in healthcare environments
(for example, electrosurgical units, cellular phones,
mobile two-way radios, electrical appliances, and
high-definition television), it is possible that high
levels of such interference due to close proximity or
strength of a source may result in disruption of
performance of this device.
This Fingertip pulse oximeter is not designed for use
in environments in which the pulse can be obscured by
electromagnetic interference. During such
interference, measurements may seem inappropriate or
the monitor may not seem to operate correctly.
8. Warranty
The company warrants pulse oximeter at the time of
.
its original purchase and for the subsequence time
period of one year.
The warranty does not cover the followings:
The device series number label is torn off or
cannot be recognized.
Damage
misconnection with other devices.
Damage to the device resulting from accidents.
Changes performed by users without the prior
written authorization of 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 further notice.
Version 20 , September 21, 2015
IBP innovative business promotion GmbH
Botzstrasse 6, D-07743 Jena, Germany
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