Apex Medical SB220 User manual

Fingertip Pulse Oximeter
Instruction for Use
SB220
PLEASE READ THIS INSTRUCTION MANUAL BEFORE USE.

USER’S MANUAL
USER’S MANUALUSER’S MANUAL
USER’S MANUAL
English
User’s Manual ...............................................................P. 1
Español
Manual de Instrucciones ..............................................P.11
Português
Instruções de Utilização...............................................P.21
FranÇais
Instructions d'utilisation...............................................P.31
German
Gebrauchsanleitung .....................................................P.41

1
English
SB200,SB210,SB220 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.

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English
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.

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English
2. Introduction
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 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.
3. Features
Measure and display reliable SpO
2
value and heart rate.
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 (SB200 except) and audio alarm (SB220 only).

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English
4. Product introduction
Top View Bottom View
1
OLED display 6
Power On/Off Button
2
Pulse strength 7
Battery compartment
3
Pulse search icon 8
Pulse rate icon
4
Alarm icon 9
SpO
2
icon
5
Battery indicator
3
5
1
9
8
7
2
6
4

5
English
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.
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.”
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 will
appear on the screen for 8 seconds after measurement. Pressing
“power switch” is to change the viewing direction. While SpO
2
exceeds the Min. threshold(90); the device will sound the alarm with
two beeps and alarm icon flickering. If the measurement fails,
the icon “- -“ will appear on screen.
The device will turn itself off automatically after 8-second idling.
While the battery power is low, the 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.

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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)
6.4Physical 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 9919: 2005

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English
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 collect
ion 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(SB200)
Complies with the European Medical Device
Directive 93/42/EEC

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English
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. These limits are designed to provide reasonable