NOTES
• At 80 MHz and 800 MHz, the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reection from structures,
objects and people.
a
Field strengths from xed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM
and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to xed
RF transmitters, an electromagnetic site survey should be considered. If
the measured eld strength in the location in which this Pulse Oximeter
is used exceeds the applicable RF compliance level above, this Pulse
Oximeter should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as
reorienting or relocating this Pulse Oximeter.
b
Over the frequency range 150 kHz to 80 MHz, eld strengths should be
less than 3 V/M.
Recommended separation distances between
portable and mobile RF communications equipment and the
Pulse Oximeter.
This Pulse Oximeter is intended for use in an electromagnetic environment
in which radiated RF disturbances are controlled. The user of this Pulse
Oximeter can help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile RF communications
equipment (transmitters) and this Pulse Oximeter as recommended
below, according to the maximum output power of the communications
equipment.
Rated
maximum
output
power of
transmitter
(W)
Separation distance according to frequency of
transmitter(m)
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.7 GHz
0.01 0.058 0.035 0.07
0.1 0.18 0.11 0.22
1 0.58 0.35 0.7
10 1.83 1.10 2.21
100 5.8 3.5 7
For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in metres (m) can be estimated using
the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTES:
• At 80 MHz and 800 MHz, the separation distance for the higher
frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reection from structures,
objects and people.
GUIDANCE AND MANUFACTURER’S DECLARATION –
ELECTROMAGNETIC EMISSIONS –
FOR ALL EQUIPMENT AND SYSTEMS
GUIDANCE AND MANUFACTURER’S DECLARATION –
ELECTROMAGNETIC IMMUNITY –
FOR ALL EQUIPMENT AND SYSTEMS
RECOMMENDED SEPARATION DISTANCES BETWEEN
PORTABLE AND MOBILE
RF COMMUNICATIONS EQUIPMENT AND THE EQUIP-
MENT OR SYSTEM – FOR EQUIPMENT OR SYSTEM THAT
ARE NOT LIFE-SUPPORTING
Symbol Description
Refer to instruction manual/booklet
%SpO
2
Pulse oxygen saturation (%)
PRbpm
Pulse rate (beats/minute)
The battery voltage is decient
(change the battery to avoid inaccurate
measurements)
1) No nger inserted
2) Inadequate signal
Battery positive electrode
Battery cathode
Exit standby mode
Adjust screen brightness
SN
Serial number
Alarm inhibit
WEEE (2002/96/EC)
IP22
Ingress of liquids rank
Storage and Transport Temperature limitation
Storage and Transport Humidity limitation
Storage and Transport Atmospheric pressure
limitation
This side up
Fragile, handle with care
Keep dry
Recyclable
EMC DECLARATION
• The device is subject to special EMC precautions and it must be installed
and used in accordance with these guidelines.
• The electromagnetic eld can affect the device performance, so other
equipment used near the device must meet the corresponding EMC
requirements. Mobile phones, X-rays or MRI devices are possible
interference source, as they can emit high-intensity electromagnetic
radiation.
• Refer to above chapters for the minimum value of user’s physiological
signal. Inaccurate result will appear when the device operates with the
values lower than the descriptions in above chapter.
• The use of ACCESSORIES, transducers and cables other than those
specied, with the exception of transducers and cables sold by the
MANUFACTURER of the ME EQUIPMENT or ME SYSTEM as replacement
parts for internal components, may result in increased EMISSIONS or
decreased IMMUNITY of the ME EQUIPMENT or ME SYSTEM.
• This device should not be used adjacent to or stacked with other
equipment and that if adjacent or stacked use is necessary, it should be
observed to verify normal operation in the conguration in which it will
be used.
• Devices or systems may still be interfered by other equipment, even if
other equipment meets the requirements of the corresponding national
standard.
• Basic performance: SpO
2
measured range: 70% - 100%, absolute error:
±2%; Pulse Rate measured range: 30 - 250 beats/minute, accuracy: ±2
beats/minute or ±2%, whichever is greater.
Guidance and manufacturer’s declaration – electromagnetic emission
This Pulse Oximeter is intended for use in the electromagnetic environment speci-
ed below. The user of this Pulse Oximeter should assure that it is used in such and
environment.
Emission test Compliance
Electromagnetic
environment – guidance
RF emissions
CISPR 11
Group 1
This Pulse Oximeter uses RF energy only for its
internal function. Therefore, its RF emissions are very
low and are not likely to cause any interference in
nearby electronic equipment.
RF emissions
CISPR 11
Class B
This Pulse Oximeter is suitable for use in all
establishments, including domestic establishments
and those directly connected to the public
low-voltage power supply network that supplies
buildings used for domestic purposes.
Guidance and manufacturer’s declaration – electromagnetic immunity
This Pulse Oximeter is intended for use in the electromagnetic environment speci-
ed below. The user of this Pulse Oximeter should assure that it is used in such an
environment.
Immunity
test
IEC 60601
test level
Compliance
level
Electromagnetic environment -
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
8 kV contact
15 kV air
8 kV contact
15 kV air
Floors should be wood, concrete or
ceramic tile. If the oor is covered
with synthetic material, the relative
humidity should be at least 30%. the
manufacturer may recommend the
ESD precautionary procedures to user.
Power frequency
(50Hz) magnetic
eld
IEC 61000-4-8
30A/m 30A/m
Power frequency magnetic elds
should be at levels characteristic
of a typical location in a typical
commercial or hospital environment.
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3V (0.15MHz–
80MHz), 6V
(in ISM bands
between
0.15MHz and
80MHz)
10 V/m
80 MHz to
2.7GH
3V
(0.15MHz–
80MHz),
6V (in ISM
bands
between
0.15MHz
and 80MHz)
10 V/m
Portable and mobile RF
communications equipment
should be used no closer to
any part of the Pulse Oximeter,
including cables, than the
recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.
Recommended separation
distance
80 MHz to 800 MHz
800 MHz to 2.7 GHz
Where P is the maximum output
power rating of the transmitter
in watts (W) according to the
transmitter manufacturer and d
is the recommended separation
distance in metres (m).
Field strengths from xed RF
transmitters, as determined
by an electromagnetic site
survey,
a
should be less than
the compliance level in each
frequency range.
b
Interference may occur in the
vicinity of equipment marked
with the following symbol:
KEY OF SYMBOLS
Note: This device and INSTRUCTION MANUAL may not contain all the following
symbols.
READING THE RESULTS
SpO
2
Display range 0% - 99%
Measured range 0% - 100%
Accuracy
70% - 100%: ±2%;
0% - 69%: unspecied.
Resolution 1%
Pulse Rate (PR)
Display range 30 - 250 beats/minute
Measured range 30 - 250 beats/minute
Accuracy ±2 beats/minute or ±2%, whichever is greater
Resolution 1 beat/minute
Accuracy under low
perfusion
Low perfusion 0.4%:
SpO
2
: ±4%;
Pulse Rate: ±2 beats/minute
or ±2%, whichever is greater
Light interference
Under normal and ambient light conditions,
the SpO
2
deviation ≤ 1%
CLEANING & DISINFECTING THE PULSE OXIMETER
1. Remove batteries before cleaning.
2. Wipe nger chamber and exterior surface with a disinfecting solution of at
least 75% isopropyl alcohol.
• Do not immerse in water or liquid.
• Do not spray any liquid directly onto the device.
3. Allow to air-dry or wipe dry with a clean, soft cloth.
HIGH-PRESSURE STERILIZATION CANNOT BE USED ON THE DEVICE
MAINTAINING & STORING THE PULSE OXIMETER
1. Inspect this device regularly. Discontinue use if you notice visible damage.
2. Replace the batteries when low-battery indicator appears or device does
not turn on.
3. Remove the batteries before storage or when not in use for an extended
timeframe.
4. Make sure the device is clean and dry before storage.
5. Store this device in a dry, well-ventilated location away from extreme
temperatures.
DISPOSAL OF DEVICE & BATTERIES
At the end of its useful product life, dispose of/recycle this device and used
batteries following local regulations to avoid environmental pollution.
• DO NOT discard in household trash.
• NEVER dispose of batteries in re.
• Dispose of/recycle used batteries following local regulations to avoid
environmental pollution.
LIMITED 2-YEAR WARRANTY
This product* has a limited warranty of 2 years from the original date of
purchase against workmanship and defects in material. If under normal use,
your product fails to operate, please contact our customer service department
at info@stareliteinc.com. A refund or replacement will be provided to you
with proof of purchase. Star Elite Inc. may deny claims of damage caused by
misuse or modications of this product.
*Excluding accessories (Batteries, Lanyard & Carrying case)
FAQS / TROUBLESHOOTING
Q: The pulse oximeter does not turn on.
A: Check the batteries for correct installation. Replace both AAA batteries
when the battery indicator is low.
Q: The display screen turns off suddenly.
A: The device enters energy-mode when not in use for several seconds. Press
ON button. The batteries are low. Install 2 new AAA batteries.
Q: The display is not showing SP0
2
and Pulse Rate.
A: Make sure the nger is fully inserted into the nger chamber. Remain still
while measuring. Nail polish or articial nails may interfere with an
accurate reading.
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