5.7 In boot-strap state,press button ,and the device is reset.
Fingernails and the luminescent tube should be on the same side.
6 Maintain, Transport and Storage
6.1 Cleaning and disinfection
The device must be turned off before cleaning, and it should not be immersed into
liquid.
Please take out the internal battery before cleaning, do not immerse it into liquid.
Use 75% alcohol to wipe the device enclosure, and use liquid soap or isopropanol to
wipe the watchband for disinfection, nature dry or clean it with clean and soft cloth.
Do not spray any liquid on the device directly, and avoid liquid penetrating into the
device.
6.2 Maintenance
A. Check the main unit and all accessories periodically to make sure that there is no
visible damage that may affect patient’s safety and monitoring performance. It is
recommended that the device should be inspected weekly at least. When there is
obvious damage, stop using it.
B. Please clean and disinfect the device before/after using it according to the User
Manual (6.1).
C. Please replace the batteries in time when low-battery appears.
D.Please take out the batteries if the device is not used for a long time.
E.
The device need not to be calibrated during maintenance.
6.3 Transport and Storage
A. The packed device can be transported by ordinary conveyance or according to
transport contract. During transportation, avoid strong shock, vibration and splashing
with rain or snow, and it can not be transported mixed with toxic, harmful, corrosive
material.
B. The packed device should be stored in room with no corrosive gases and good
ventilation. Temperature: -40°C~+60°C; Relative humidity: ≤95%.
7 Troubleshooting
Trouble
Possible Reason
Solution
The SpO
2
and
Pulse Rate
can not be
displayed
normally
1)
The finger is not properly
inserted.
2)
The finger is shaking or
the patient is moving.
3)
The device is not used in
environment required by
the manual.
4)
The device works
abnormally.
1)
Please insert the finger
properly and measure
again.
2)
Let the patient keep
calm.
3)
Please use the device
in normal
environment.
4)
Please contact the
after-sales.
The SpO
2
and
Pulse Rate
are not
displayed
stably
1)
The finger is not placed
inside deep enough.
2)
The finger is shaking or the
patient is moving.
1)
Place the finger
properly and try again.
2)
Let the patient keep
calm
The device
can not be
turned on
1)
The battery is drained
away or almost drained
away.
2)
The battery is installed
incorrectly.
3)
The device’s malfunction.
1)
Please change
batteries.
2)
Please Install the
battery again.
3)
Please contact the
local service center.
The display is
off suddenly
1)
The device enters into the
energy saving mode.
2)
Low battery.
3)
The device works
abnormally.
1)
Normal.
2)
Please charge the
battery.
3)
Please contact the
after-sales.
8 Key of Symbols
Symbol
Description
Type BF
Refer to instruction manual/booklet
%SpO
2
The pulse oxygen saturation(%)
PRbpm
Pulse rate (bpm)
The battery voltage indication is deficient
(change the battery in time avoiding the inexact measure)
1. No finger inserted
2. An indicator of signal inadequacy
Battery positive electrode
Battery cathode
Exit standby mode
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
European Representative
This item is compliant with Directive 93/42/EEC of 14
june 1993 concerning medical devices; Including, at 21
march 2010, the amendments by Council Directive
2007/47/EEC.
Note
：
Your device may not contain all the following symbols.
9 Function Specification
SpO
2
[see note 1]
Display range
0% ~ 99%
Measured range
0% ~ 100%
Accuracy [see note 2]
70%~100%: ±2%;
0%~69%: unspecified.
Resolution
1%
PR
Display range
30 bpm ~ 250 bpm
Measured range
30 bpm ~ 250 bpm
Accuracy
±2 bpm or ±2%, whichever is greater.
Resolution
1 bpm
Accuracy under low
perfusion [see note 3]
Low perfusion 0.4%:
SpO
2
: ±4%;
PR: ±2 bpm or ±2%, whichever is greater
Light interference
Under normal and ambient light conditions, the SpO
2
deviation ≤ 1%
Optical sensor [see note 4]
Red light
Wavelength: about 660 nm, optical output power: < 6.65 mW
Infrared light
Wavelength: about 905 nm, optical output power: < 6.75 mW
Safety class
Internally powered equipment, type BF applied part
International
Protection
IP22
Working voltage
DC 2.6 V ~ 3.6 V
Working current
≤ 25 mA
Power supply
1.5V (AAA size) alkaline batteries × 2 or rechargeable battery
Battery life
Two batteries can work continually for 24 hours
Dimension and Weight
Dimension
61 (L) × 36 (W) × 32 (H) mm
Weight
About 60g (with the batteries)
Note 1: the claims of SpO
2
accuracy shall be supported by clinical study measurements
taken over the full range. By artificial inducing, get the stable oxygen level to the range
of 70 % to 100 % SpO
2
, compare the SpO
2
values collected by the secondary standard
pulse oximeter equipment and the tested equipment at the same time, to form paired
data, which are used for the accuracy analysis.
There are 12 healthy volunteers (male: 6. female: 6; age: 18~45; skin color: black: 2, light: 8,
white: 2) data in the clinical report.
Note 2: because pulse oximeter equipment measurements are statistically distributed,
only about two-thirds of pulse oximeter equipment measurements can be expected to
fall within ±Arms of the value measured by a CO-OXIMETER.
Note 3: percentage modulation of infrared signal as the indication of pulsating signal
strength, patient simulator has been used to verify its accuracy under conditions of low
perfusion. SpO
2
and PR values are different due to low signal conditions, compare them
with the known SpO
2
and PR values of input signal.
Note 4: optical sensors as the light-emitting components, will affect other medical
devices applied the wavelength range. The information may be useful for the clinicians
who carry out the optical treatment.For example, photodynamic therapy operated by
clinician.
Note 5: Patient simulator has been used to verify the pulse rate accuracy, it is stated as
the root-mean-square difference between the PR measurement value and the value set
by simulator.
EMC
Note:
The device is subject to special EMC precautions and it must be installed and used in
accordance with these guidelines.
The electromagnetic field 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 specified, 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.
The 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 configuration 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%; PR
measured range: 30 bpm ~ 250 bpm, accuracy: ±2 bpm or ±2%, whichever is greater.
Appendix 1
Guidance and manufacture's declaration
Guidance and manufacture’s declaration – electromagnetic emissions-
for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic emission
The
Pulse Oximeter
is intended for use in the electromagnetic environment specified below.
The customer of the user of the
Pulse Oximeter
should assure that it is used in such and
environment.
Emission test
Compliance
Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1
The
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 emission
CISPR 11
Class B
The
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 manufacture’s declaration – electromagnetic immunity –
for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic immunity
The
Pulse Oximeter
is intended for use in the electromagnetic environment specified below.
The customer or the user of
Pulse Oximeter
should assure that it is used in such an
environment.
Immunity
test
IEC
60601
test level
Complia
nce 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 floor are 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
field
IEC 61000-4-8
30A/m
30A/m
Power frequency magnetic fields
should be at levels characteristic of
a typical location in a typical
commercial or hospital
environment.
Guidance and manufacture’s declaration – electromagnetic immunity –
for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacture’s declaration – electromagnetic immunity
The
Pulse Oximeter
is intended for use in the electromagnetic environment specified below.
The customer or the user of
Pulse Oximeter
should assure that it is used in such an
environment.
Immunity
test
IEC 60601
test level
Compliance
level
Electromagnetic environment - guidance
Conducted
RF IEC
61000-4-6
Radiated
RF IEC
61000-4-3
3V(0.15MH
z–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 fixed 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:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed 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 fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the Pulse Oximeter is
used exceeds the applicable RF compliance level above, the Pulse Oximeter should be
observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the Pulse Oximeter.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3
V/m.
Recommended separation distances between portable and mobile
RF communications equipment and the EQUIPMENT or SYSTEM –
for EQUIPMENT or SYSTEM that are not LIFE-SUPPORTING
Recommended separation distances between
portable and mobile RF communications equipment and the
Pulse Oximeter.
The
Pulse Oximeter
is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the
Pulse Oximeter
can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the
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
P
V
d
1
5
.
3
80 MHz to 800 MHz
P
E
d
1
5
.
3
800 MHz to 2.7 GHz
P
E
d
1
7
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.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency
range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reflection from structures, objects and people.
P
V
d
1
5
.
3
P
E
d
1
5
.
3
P
E
d
1
7
