Rossmax SB200 Instructions For Use

SB200 Fingertip Pulse Oximeter
Instruction for Use

1. Safety information

WARNING: The SpO device is to be operated by
2
trained personnel only.
WARNING: Do not use the SpO
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of flammable anesthetics or gas to prevent explosion hazard.
WARNING: Do not use the SpO
Magnetic Resonance Imaging (MRI) ambience.
WARNING: The SpO readings and pulse signals can be
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affected by the conditions of ambience and patient.
WARNING: Do not open up the SpO
the battery cover. The SpO device is without any
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user-serviceable part inside and only qualified service
personnel can perform maintenance service.
WARNING: Do not expose the SpO
extreme moisture (such as rain) to ensure accurate
performance and device safety.
WARNING: If the accuracy of measurement by
the SpO device is uncertain, check the patient's vital
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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 and
to check patient's condition regularly.
WARNING: The SpO device is not intended for
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the use of neonatal.
WARNING: Do not use the SpO
other devices (such as, the cuff of blood pressure
monitor) that may interfere with blood flow and cause
inaccurate measurement.
Warning: The SpO device will be affected by
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electromagnetic interference or strong ambient light
source during operation.
WARNING: User should stay calm and position finger
stably. The accuracy of measurement taken right after exercise
or during hand shaking could be compromised.
WARNING: SpO should not be applied to a body part
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other than the finger or to a wounded body part.
Warning: Please remove the batteries from the
battery compartment if the device will not be used for
a long period of time.
Introduction
1.
The Fingertip pulse oximeter is to spot-check oxygen
saturation in blood (SpO ) and pulse rate. The pulse
2
oximeter is used on adults and pediatric 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 of blood flow. The ratio of
light absorbed is translated in an oxygen saturation
measurement (SpO ). 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.

2. Features

Measure and display reliable SpO
rate and vascular age analysis.
Single turn-on key for easy operation.
Bright Organic 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.
Visual alarm and audio alarm.

3. Product introduction

1
2
3
4
5
device in the presence
device in the
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6
1 OLED display
2 Pulse strength
device except for
3 Pulse search icon
2
4 Alarm icon or
vascular age
5 Battery indicator
device to
2

4. 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. Information of version appears on the
screen. The device is then in the "self-test" mode with
the software version shown. The measurement starts at
the completion of the "self-test."
Insert your finger into the device. For best results use
the middle finger on your left hand.
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 screen in 8 seconds
average. The readings and icon of vascular age will
appear on the screen in 30 seconds or maximum 2
minutes. Pressing "power switch" is to change the
device with
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viewing direction. While SpO
threshold (90); the device will sound the alarm with
two beeps and alarm icon
measurement fails, the icon "- -"will appear on screen.
Reading flashing while SpO
sensor is malfunctioning, displaying "Er" signal.
Vascular age is classified into 6 levels as follows:
APG
APG
Level 1: Artery and blood circulation in excellent condition
Level 2: Artery and blood circulation in good condition
Level 3: Artery and blood circulation in above average
Condition
Level 4: Artery and blood circulation in average condition
Level 5: Artery and blood circulation in below average
condition
Level 6: Artery and blood circulation in poor condition
Warnings: The classification of artery and blood
circulation condition is for reference only. Please consult your
physician for further advice.
When the vessel elasticity cannot be measured, it will
show
The device will turn itself off automatically after
8-second idling. While the battery power is low, the
2
battery indicator icon will flash twice per second.
Please replace the batteries as soon as possible or the
device will be off automatically in 30 seconds.

5. Specifications

6.1 Performance
Scope of measurement: SpO
value and heart
Pulse rate: 30-250 bpm (beats per minute)
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Accuracy: SpO
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)
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,
ISO 80601-2-61
Top View Bottom View
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8
7
6 Power On/Off Button
7 Battery compartment
8 Pulse rate icon
9 SpO icon
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exceeds the Min.
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flickering. If the
is low. While LED or
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APG APG
APG
APG
: 35% - 99%
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:70%-99%:±2%,35%-69%:
unspecified
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6.6 Markings
Type BF (Body Floating)
Drip proof
ATTENTION
Read instructions for use before use.
Date of manufacture
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.
Complies with the European Medical
Device Directive 93/42/EEC as amended
by 2007/47/EC

7. Problem shooting and maintenance

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
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 as amended by
2007/47/EC. These limits are designed to provide
reasonable protection against harmful interference in a
typical medical installation. However, because of the
proliferation of radio-frequency
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.
interference, measurements may seem inappropriate or
the monitor may not seem to operate correctly.

6. 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 to the
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 11494, Taiwan
Tel: +886-2-2659-7888 Fax: +886-2-2659-7666
.
www.rossmax.com
The text is subject to change without
further notice.
Version 11; Jan. 20, 2016
IBP innovative business promotion
GmbH
Botzstrasse 6, D-07743 Jena, Germany
transmitting
During such
device resulting from