Page 1
I
Pulse
Pulse
Pulse
Oximeter
Oximeter
Oximeter
Page 2
II
Instructions
Instructions
Instructions
tototo
User
User
User
Dear u sers, thank you very much for purchasing the Pulse Oximeter .
This Manual is written and compiled in accordance with the council directive MDD 93/42/EEC for
medical devices and harmonized standards . In case of modifications and software upgrades, the
information contained in this document is subject to change without notice.
The Manual describes, in accordance with the Pulse Oximeter’s features and requirements, main
structure, functions, specifications, correct methods for transportation, installation, usage, operation,
repair, maintenance and storage, etc. as well as the safety procedures to protect both the user and
equipment. Ref er to the respective chapters for details.
Please read the User Manual carefully before using this product . T he User Manual which describes
the operating procedures should be followed strictly.Failure to follow the User Manual may cause
measuring abnormality, equipment damage and human injury. The manufacturer is NOT responsible
for the safety, reliability and performance issues and any monitoring abnormality, human injury and
equipment damage due to user s' negligence of the operation instructions. The manufacturer’s
warranty service does not cover such faults .
Owing to the forthcoming renovation, the specific products you received may not be totally in
accordance with the description of this User Manual.
We
would sincerely regret for that.
T his product is medical device, which can be used repeatedly .
WWW
ARNING:
ARNING:
ARNING:
UUU
ncomfortable
ncomfortable
ncomfortable
ororor
painful
painful
painful
feeling
feeling
feeling
may
may
may
appear
appear
appear
ififif
using
using
using
the
the
the
device
device
device
ceaselessly,
ceaselessly,
ceaselessly,
especially
especially
especially
for
for
for
the
the
the
mmm
icrocirculat
icrocirculat
icrocirculat
ion
ion
ion
barrier
barrier
barrier
patients.
patients.
patients.
ItItIt
isisis
recommended
recommended
recommended
that
that
that
the
the
the
sensor
sensor
sensor
should
should
should
not
not
not
bebebe
applied
applied
applied
tototo
the
the
the
same
same
same
finger
finger
finger
for
for
for
over
over
over
222
hours.
hours.
hours.
FFF
ororor
the
the
the
special
special
special
patients,
patients,
patients,
there
there
there
should
should
should
bebebe
aaa
more
more
more
prudent
prudent
prudent
inspecting
inspecting
inspecting
ininin
the
the
the
placing
placing
placing
process.
process.
process.
TTT
hehehe
device
device
device
can
can
can
not
not
not
bebebe
clipped
clipped
clipped
ononon
the
the
the
edema
edema
edema
and
and
and
tender
tender
tender
tissue
tissue
tissue
...
TTT
hehehe
light
light
light
(the
(the
(the
infrared
infrared
infrared
isisis
ininin
visible
visible
visible
)))
emitted
emitted
emitted
from
from
from
the
the
the
device
device
device
isisis
harmful
harmful
harmful
tototo
the
the
the
eyes,
eyes,
eyes,
sososo
the
the
the
user
user
user
and
and
and
the
the
the
maintenance
maintenance
maintenance
man
man
man
should
should
should
not
not
not
stare
stare
stare
atatat
the
the
the
light.
light.
light.
Testee
Testee
Testee
can
can
can
not
not
not
use
use
use
enamel
enamel
enamel
ororor
other
other
other
makeup.
makeup.
makeup.
Testee
Testee
Testee
’’’
sss
fingernail
fingernail
fingernail
can
can
can
not
not
not
bebebe
too
too
too
long.
long.
long.
Please
Please
Please
refer
refer
refer
tototo
the
the
the
correlative
correlative
correlative
literature
literature
literature
about
about
about
the
the
the
clinical
clinical
clinical
restrictions
restrictions
restrictions
and
and
and
ccc
auauau
ttt
ion
ion
ion
...
This
This
This
device
device
device
isisis
not
not
not
intended
intended
intended
for
for
for
treatment
treatment
treatment
...
The User Manual is published by our company . All rights reserved.
Page 3
III
CONTENTS
1Safety
1Safety
1Safety
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111
1.1Instructions for safe operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.2Warning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.3Attention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
2Overview
2Overview
2Overview
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222
2.1Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
2.2Major applications and scope of application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
2.3Environment requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
3Principle
3Principle
3Principle
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333
4Technical
4Technical
4Technical
specifications
specifications
specifications
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333
4.1Main performance
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3
4.2Main Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
5Installation
5Installation
5Installation
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555
5.1View of the front panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
5.2Wristband installation and probe connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
5.3Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
6Operating
6Operating
6Operating
Guide
Guide
Guide
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666
6.1Application method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
6.2Attention for operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
6.3Clinical restrictions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
7Maintain
7Maintain
7Maintain
、 transportation
transportation
transportation
and
and
and
storage
storage
storage
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121212
7.1Cleaning and Disinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
7.2Maintain
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12
7.3Transportation and storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
8Troubleshooting
8Troubleshooting
8Troubleshooting
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121212
9Key
9Key
9Key
ofofof
Symbols
Symbols
Symbols
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131313
10Function
10Function
10Function
Specification
Specification
Specification
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131313
Page 4
1
111
Safety
Safety
Safety
1.1
1.1
1.1
Instructions
Instructions
Instructions
for
for
for
safe
safe
safe
operations
operations
operations
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 about cables and transducers. It is
recommended that the device should be inspected once a week a t least. When there is obvious
damage, stop us ing the device.
Necessary maintenance must be performed by qualified service engineers
ONLY .
Users are not
permitted to maintain it by themselves.
The oximeter cannot be used together with devices not specified in User’s Manual. Only the
accessory that appointed or recommendatory by manufacture can be used with this device.
This product is calibrated before leav ing factory .
1.2
1.2
1.2
Warning
Warning
Warning
Explosive hazard — DO NOT use the oximeter in environment with inflammable gas such as
some ignitable anesthetic agents.
DO NOT use the oximeter while the testee measured by MRI and CT.
Please do not break the wristband, for fear it becomes out of use, or the unexpected drop of the
device which is due to the looseness of the wristband in the process of using. U sers who are allergic
to the wristband is not recommended to use it.
The person who is allergic to rubber can not use this device.
The disposal of scrap instrument and its accessories and packings (including battery , plastic
bags, foams and paper boxes) should follow the local laws and regulations.
Please check the packing before use to make sure the device and accessories are totally in
accordance with the packing list, or else the device may have the possibility of working abnormally.
Please choose the accessories and probe which are approved or manufactured by the
manufacturer, or else it may damage the device.
The device can only be matched with the compatible probe.
Please don't measure this device with function test paper for the device's related information.
1.3
1.3
1.3
Attention
Attention
Attention
Keep the oximeter away from dust, vibration, corrosive substances, explosive materials, high
temperature and moisture.
If the oximeter gets wet, please stop operating it.
When it is carried from cold environment to warm or humid environment, please do not use it
immediately.
DO NOT operate keys on front panel with sharp materials.
High temperature or high pressure steam disinfection of the oximeter is not permitted. Refer to
User Manual in the relative chapter ( 7 .1) for instructions of cleaning and disinfection .
Do not have the oximeter immerged in liquid. When it needs cleaning, please wipe its surface
with medical alcohol by soft material. Do not spray any liquid on the device directly.
When cleaning the device with water, the temperature should be lower than 60 ℃ .
As to the fingers which are too thin or too cold, it would probably affect the normal measure of
the patients' SpO
2
and pulse rate, please clip the thick finger such as thumb and middle finger deeply
Page 5
2
enought into the probe.
Whether the device is used to adult or infant,it depends on the probe selected.
The update period of data is less than 5 seconds, which is changeable according to different
individual pulse rate.
Please read the measured value when the waveform on screen is equably and steady-going,
This measured value is optimal value. And the waveform at the monment is the standard one.
If some abnormal conditions appear on the screen during test process, pull out the finger and
reinsert to restore normal use.
The device has normal useful life for three years since the first electrified use.
This device has the function of alarming, users can check on this function according to chapter
6.1 as a reference.
The device has the function of limits alarming, when the measured data is beyond the highest
or lowest limit, the device would start alarming automatically on the premise of the alarming function
is on.
The device has the function of alarming, this function can either be paused, or closed for good,
please check the chapter 6.1 as a reference.
The device may not work for
all
patients. If you are unable to achieve stable readings,
discontinue use.
222
OOO
verview
verview
verview
The pulse oxygen saturation is the percentage of Hb O2in the total Hb in the blood, so-called the O
2
concentration in the blood. It is an important bio-parameter for the respiration.
A
number of diseases
relating to respiratory system may cause the decrease of SpO
2
in the blood, furthermore, some other
causes such as the malfunction of human body's self-adjustment, damages during surgery , and the
injuries caused by some medical checkup would also lead to the difficulty of oxygen supply in
human body, and the corresp onding symptoms would appear as a consequence, such as vertigo,
impotence, vomit etc. Serious symptoms might bring danger to human's life. Therefore, prompt
information of patients' SpO
2
is of great help for the doctor to discover the potential danger, and is of
great importance in the clinical medical field.
The Pulse Oximeter features in small volume, low power consumption, convenient operation and
being portable.It is only necessary for patients to put one of his fingers into a probe for diagnosis, and
a display screen will directly show the measured value of pulse oxygen s aturation with the high
veracity and repetition.
222
.1.1.1
Features
Features
Features
A.A.A.
Operation of the product is simple and convenient.
B.B.B.
The product is small in volume, light in weight and convenient in carrying.
C.C.C.
L ow power consumption
222
.2.2.2
Major
Major
Major
applications
applications
applications
and
and
and
scope
scope
scope
ofofof
application
application
application
The Pulse Oximeter can be used in measur ing t he pulse oxygen s aturation and pulse ratethrough
finger. The product is suitable for being used in family, hospital, o xygen b ar, community healthcare,
physical care in sports (It can be used before or after doing sports, and it is not recommended to use
the device during the process of having sport ) and etc.
Page 6
3
The
The
The
problem
problem
problem
ofofof
overrating
overrating
overrating
would
would
would
emerge
emerge
emerge
when
when
when
the
the
the
patient
patient
patient
isisis
suffering
suffering
suffering
from
from
from
toxicosis
toxicosis
toxicosis
which
which
which
caused
caused
caused
bybyby
carbon
carbon
carbon
monoxide,
monoxide,
monoxide,
the
the
the
device
device
device
isisis
not
not
not
recommended
recommended
recommended
tototo
bebebe
used
used
used
under
under
under
this
this
this
circumstance.
circumstance.
circumstance.
222
.3.3.3
Environment
Environment
Environment
requirements
requirements
requirements
Storage Environment
a) Temperature : - 40 ℃ ～ + 60 ℃
b ) Relative h umidity : 5 % ～ 95 %
c ) Atmospheric pressure : 500h P a ～ 106 0h P a
Operating Environment
a) Temperature : 0 ℃ ～ 5 0 ℃
b ) Relative Humidity : 15 % ～ 95 %
c ) Atmospheric pressure: 700h P a ～ 106 0h P a
333
Principle
Principle
Principle
Principle of the Oximeter is as follows: An experience formula of data process is established taking
use of Lambert Beer Law according to Spectrum Absorption Characteristic s of Reductive
Hemoglobin ( Hb ) and Oxyhemoglobin ( Hb O2) in glow & near-infrared zones. Operation principle of
the device is: Photoelectric O xyhemoglobin I nspection
T
echnology is adopted in accordance with
Capacity Pulse Scanning & Recording Technology, so that two beams of different wavelength of
lights can be focused onto human nail tip through per spective clamp finger-type sensor. Then
measured signal can be obtained by a photosensitive element, information acquired through which
will be shown on screen through treatment in electronic circuits and microprocessor.
Figure 1.
444
Technical
Technical
Technical
specifications
specifications
specifications
444
.1.1.1
Main
Main
Main
performance
performance
performance
A. SpO
2
value display
B. P ulse rate value display , bar graph display
C. Pulse waveform display
D. L ow-voltage indicat ion: low-voltage indicator appears before working abnormally which is due
to low-voltage
Page 7
4
E. The display mode can be changed
F. Screen brightness can be changed
G.
A
pulse sound indicat ion
H. With alarm function
III
. With SpO
2
value and pulse rate value of storage, the stored data can be uploaded to computers
J. It can be connected with an external oximeter probe
KKK
. Real-time data can be transmitted to computers
L. With clock function
444
.2.2.2
Main
Main
Main
Parameters
Parameters
Parameters
A.A.A.
Measurement
Measurement
Measurement
ofofof
SpO
2
Measur ing range: 0 % ～ 100 ％
Accuracy:
When the SpO
2
m easur ing range is 7 0% ～ 100 ％ ,t he permission of absolute error is ± 2 ％；
below 70% unspecified
B.B.B.
Measurement
Measurement
Measurement
ofofof
pulse
pulse
pulse
rate
rate
rate
Measur ing range: 25 bpm ～ 2 5 0bpm
Accuracy: ± 2 bpm or ± 2% (select larger)
C.C.C.
Resolution
Resolution
Resolution
SpO
2
: 1%, Pulse rate : 1 bpm.
D.D.D.
Measurement
Measurement
Measurement
Performance
Performance
Performance
ininin
Weak
Weak
Weak
Filling
Filling
Filling
Condition
Condition
Condition
SpO
2
and pulse rate can be shown correctly when pulse-filling ratio is 0.4% . SpO
2
error is ± 4%,
pulse rate error is ± 2 bpm or ± 2% (select larger).
E.E.E.
Resistance
Resistance
Resistance
tototo
surrounding
surrounding
surrounding
light
light
light
The deviation between the value measured in the condition of man-made light or indoor natural light
and that of darkroom is less than ± 1%.
F.F.F.
Power
Power
Power
supply
supply
supply
requirement:
requirement:
requirement::3.6 V DC ~ 4.2V DC.
G.G.G.
Optical
Optical
Optical
Sensor
Sensor
Sensor
Red light (wavelength is 660nm ， 6.65mW )
Infrared (wavelength is 880 nm , 6.75mW )
Page 8
5
555
Installation
Installation
Installation
555
.1.1.1
View
View
View
ofofof
the
the
the
front
front
front
panel
panel
panel
Figure 2. front view
5.2
5.2
5.2
Wristband
Wristband
Wristband
installation
installation
installation
and
and
and
probe
probe
probe
connection
connection
connection
A.A.A.Put
one side of the wristband on which there is no ring through the belt hole above the device,
then put
it
through the other belt hole under the device.
B.B.B.
M ake the alignment signs on the probe in accordance with the alignment signs on the device,
then plug the probe into the jack.
C.C.C.
It appears as the following figure after installation.
Figure 3.
555
.3.3.3
Accessories
Accessories
Accessories
A.A.A.
a wristband
Page 9
6
B.B.B.
a User Manual
C.C.C.
a power adapter
D.D.D.
a data line
E.E.E.
a disk (PC software)
F.F.F.
an oximeter probe
666
Operating
Operating
Operating
Guide
Guide
Guide
666
.1.1.1
Application
Application
Application
method
method
method
A.A.A.
I nstall the wristband and probe according to the instructions of chapter 4.2, then put the finger
into the probe.
a)a)a)
T
urn on the device by long pressing the button on the panel.
b)b)b)
Do not shake the finger and keep the patient in a stable state during the process.
c)c)c)
The data can be read directly from the screen on the measuring interface.
Fingernails
Fingernails
Fingernails
and
and
and
the
the
the
luminescent
luminescent
luminescent
tube
tube
tube
should
should
should
bebebe
ononon
the
the
the
same
same
same
side.
side.
side.
IfIfIf
the
the
the
alarm
alarm
alarm
function
function
function
isisis
ononon
,,,
the
the
the
device
device
device
will
will
will
provide
provide
provide
midium-priority
midium-priority
midium-priority
alarm
alarm
alarm
signal
signal
signal
when
when
when
probe
probe
probe
ororor
finger
finger
finger
isisis
out
out
out
and
and
and
intermittent
intermittent
intermittent
alarm
alarm
alarm
will
will
will
occur.
occur.
occur.
Figure 4.
（ Actual probe may be different with the probe as figure 4,please accept the actual probe with the
device ）
B.B.B.
Change
Change
Change
display
display
display
direction
direction
direction
O n the measuring interface,short press the button to enter the clock interface, and then change the
display direction by short pressing the button within 30 seconds.
C.C.C.
Enter
Enter
Enter
and
and
and
exit
exit
exit
the
the
the
clock
clock
clock
interface
interface
interface
a)a)a)
O n the measuring interface, short press the button in order to enter the clock interface, and
it
will
automatically return to the measuring interface if there is no other operations within 30 seconds.
b)b)b)
O n the measuring interface, long press the button for about 10 seconds in order to enter the clock
interface, and the device would return to the measuring interface by long pressing the button again.
D.D.D.
Pause
Pause
Pause
alarm
alarm
alarm
a)a)a)
Alarm including the alarm of measure data's going beyond the limits, the alarm of low-voltage,
the alarm of probe or finger's out of position.
Page 10
7
b)b)b)
On the measuring interface, if the alarm function is on, during the period of alarming, you can
pauseitby short pressing the button, but the function will be renewed in about 60 seconds.
c)c)c)
If you want to turn off the alarm for good, you should enter the menu for operation.
E.E.E.
Menu
Menu
Menu
operations
operations
operations
W hen the device is under the measuring interface, long press the button for about 1 second in order to
enter the menu interface shown as figure 5 ( when the display mode is upright mode, the device
cannot enter the menu interface in this situation, you nee d to short press the button again to adjust the
display mode to transverse mode so that the device can enter the menu interface). U sers can adjust the
setting through the main menu, such as backlight, alarm, clock, data transmission(with the data line),
data storage, and power off. T he specific operation methods are as the following:
Figure 5. Main Menu Interface
a)a)a)
Backlight
Backlight
Backlight
adjustment
adjustment
adjustment
On the main menu interface, short press the button to move the menu choice bar to “ Brightness ” , then
you can adjust the brightness of the screen by long pressing the button.
b)b)b)
Alarm
Alarm
Alarm
setting
setting
setting
On the main menu interface, short press the button to move the menu choice bar to “ Alarm ” , then the
device would enter the alarm setting menu which is shown as figure 6 if you long press the button.
a.a.a.
The
The
The
highest/lowest
highest/lowest
highest/lowest
alarm
alarm
alarm
lll
imit
imit
imit
setting
setting
setting
S hort press the button to move the menu choice bar to “ Direction ” , then you can choose the
highest/lowest limit by long pressing the button.If you want to raise the alarm limit of SpO
2
or pulse
rate, you should move the “ Direction ” to “ up ” , then short press the button in order to choose the
parameter that you want to raise: T he highest limit of SpO
2
( SpO
2
ALM HI ), the lowest limit of
SpO
2
( SpO
2
ALM LO ), the highest limit of pulse rate (PR ALM HI）, the lowest limit of puls
e
rate （ PR ALM LO
）
, then you can raise the data to the number that you want by long pressing t he
button. I n the same way, if you want to reduce the alarm limit of SpO
2
or pulse rate, you should move
the “ Direction ” to “ down ” , short press the button to choose the parameter that you want to reduce,
Page 11
8
then adjust the number by long pressing the button.
IfIfIf
the
the
the
alarm
alarm
alarm
function
function
function
isisis
ononon
,,,
the
the
the
device
device
device
will
will
will
provide
provide
provide
midium-priority
midium-priority
midium-priority
alarm
alarm
alarm
signal
signal
signal
when
when
when
the
the
the
data
data
data
ofofof
SpO
SpO
SpO
222
ororor
pulse
pulse
pulse
rate
rate
rate
isisis
beyond
beyond
beyond
the
the
the
limit
limit
limit
and
and
and
intermittent
intermittent
intermittent
alarm
alarm
alarm
will
will
will
occur.
occur.
occur.
bbb
...
The
The
The
aaa
larm
larm
larm
state
state
state
setting
setting
setting
S hort press the button to move the menu choice bar to “ Alarm ” , then choose the alarm state (on/off)
by long pressing the button, choose “ on ” to open the alarm function, and choose “ off ” to close
it
for
good.
Figure 6. Alarm Setting Menu
ccc
...
Pulse
Pulse
Pulse
sound
sound
sound
indication
indication
indication
setting
setting
setting
S hort press the button to move the menu choice bar to “ Pulse Sound ” , then choose the pulse sound
indication state (on/off) by long pressing the button, press “ on ” to open the function, and press “ off ”
to close it.
d.Exit
d.Exit
d.Exit
Short press the button to move the menu choice bar to"Exit" , you can exit the alarm setting menu as
well as return to the main menu by long pressing the button.
c ） Clock
Clock
Clock
setting
setting
setting
On the main menu interface, short press the button to move the menu choice bar to “ Clock ” , then
enter the clock setting interface by long pressing the button.
Page 12
9
Figure 7. Clock Setting Menu
a.a.a.
W hen entering the clock setting menu, the menu choice bar would be on the item of “ set time ” ,
and the state would always be “ no ” wheneveritenters the clock setting menu on the purpose of
avoiding unexpected changes of time due to improper operation.
Y
ou can change the state by long
pressing the button, choose “ yes ” to reset the time, choose “ no ” to forbid time resetting.
bbb
...
S hort press the button to move the menu choice bar to the parameter that you want to change,
then adjust the data by long pressing the button.
c.c.c.
S hort press the button to move the menu choice bar to “ Exit ” , then exit the clock setting menu by
long pressing the button. I f you have reset the time or date ,when exiting the clock setting menu,
firstly the renewed time and date would be displayed on the screen, then
it
returns to the main menu;
if you did ’treset the time and date , when exiting the clock setting menu, the device would return to
the main menu directly.
d ） Real-time
Real-time
Real-time
data
data
data
transmission
transmission
transmission
setting
setting
setting
F irstly, please install the affiliated software into the computer, and two icons would appear on the
desktop after installation. T he icon of " SpO2 " is a program for receiving real-time data which is
shown as figure 8; the icon of " SpO2 Review " is a program for receiving stored data which is shown
as figure 9.
a.a.a.
P lease connect the device to computer with the affiliated data line , then double click the " SpO2
" icon to start the program.
b.b.b.
On the main menu interface, short press the button to move the menu choice bar to"Usb" , long
press the button to choose whether transmit the real-time data to computer which displays the data
Synchronously or not , choose “ on ” to permit transmission , choose “ off ” to forbid transmission.
c.c.c.
When you unplug the data line from computer, there is a dialog box "Save data at view"
appearing on the desktop, in which you can input some patient's basic information.
Figure 8. SpO2 program
Page 13
10
Figure 9. SpO2 Review program
III
fff
the
the
the
users
users
users
choose
choose
choose
tototo
turn
turn
turn
ononon
the
the
the
synchronizing
synchronizing
synchronizing
display
display
display
function
function
function
ononon
computer,
computer,
computer,
ititit
would
would
would
probably
probably
probably
take
take
take
several
several
several
second
second
second
sss
for
for
for
the
the
the
data
data
data
tototo
appear
appear
appear
ononon
the
the
the
computer
computer
computer
screen.
screen.
screen.
e ） Data
Data
Data
storage
storage
storage
setting
setting
setting
This device has the function of 24 hours data storage ,ithas the capability of accurately storing pulse
rate and SpO
2
data, then transmit the data to computer with the data line for replay and analysis.
a.a.a.
On the main menu interface, short press the button to move the menu choice bar to “ Record ” ,
then long press the button to choose whether store the data or not, choose “ on ” to permit storing,
choose “ off ” to forbid storing.
b.b.b.
The device can storage starting time automaticly.
ccc
...
If the data storage fun c tion is being turned on, when return to the measuring interface, a red
"REC"sign and a flashing red dot would appear on screen, which means the device is in a state of
storing.
ddd
...
In the state of storing, whatever interface the device is on (measuring interface, menu
interface,clock interface), the sign "Recording" would appear on the screen in 30 seconds, then the
clock interface would appear in succession after several seconds .and then the screen will be
automatically shut down. If short press the button at this moment, the sign "Recording" would appear
on the screen, and then the screen will be automatically shut down again ; if long press the button , the
device would return to the former interface.
eee
...
I f turning on the data storage function, the former data storage will be automatically removed.
fff
...
In the state of data storing, after the screen is automatically shut down, the pulse sound indication
would be off for saving power.
ggg
...
W hen the storage space is full,itdisplays “ Memory is full ” on the screen, and then shut down in
a few seconds. But
it
will still display “ Memory is full ” by the next time you turn on the device on the
purpose of warning the user, if press the button again,
it
will enter the measuring interface.
fff
） Stored
Stored
Stored
data
data
data
transmission
transmission
transmission
setting
setting
setting
a.a.a.
Please connect the device with computer by the data line which is equipped with the device,then
double click"SpO2 Review"icon to open"SpO2 Review"program , click the ‘ New Session
’
Icon in the
software, enter the patient data and then click ‘ ok ’ . The Software will then display “ device
connected, waiting for data ” .
b.b.b.
On the main menu interface,short press the button to move the menu choice bar to"Upload", then
long press the button to choose whether transmitt the data to computer for displaying and analysing
or not. C hoose “ on ” to permit transmission, choose “ off ” to forbid transmission.
c.c.c.
In the state of storing,
it
is not applicable for the users to upload the stored date to computer.
d.d.d.
When the upload of stored data is finished,the menu choice bar will move to "Power
off"automatically .
ggg
） Power
Power
Power
off
off
off
Page 14
11
On the main menu interface, short press the button to move the menu choice bar to "Power off", then
long press the button to shut down the device.
hhh
） Exit
Exit
Exit
the
the
the
main
main
main
menu
menu
menu
On the main menu interface,short press the button to move the menu choice bar to "Exit",then long
press the button to exit the main menu.
F.F.F.
Charge
Charge
Charge
There are two kinds of charging methods:
a ） Connect the device with computer by data line, then the device should be under charging state.
b)b)b)
C onnect the device with power supply by power adaptor, then the device should be under
charging state.
c)c)c)
W hen the device is in the state of battering charging, the indication light appears to be orange,
and when the battery status is full, the light turns to green.
6.6.6.
222
Attention
Attention
Attention
for
for
for
operation
operation
operation
A. Please check the device before using, and confirm thatitcan work normally.
BBB
. The finger should be in a proper position (see the attached illustration of figure 4 for reference),
or elseitmay result in inaccurate measure.
CCC
. The SpO
2
sensor and photoelectric receiving tube should be arranged in a way with the subject’s
arteriole in a position there between .
DDD
. The SpO
2
sensor should not be used at a location or limb tied with arterial canal or blood
pressure cuff or receiving intravenous injection.
EEE
. Do not fix the SpO
2
sensor with adhesive or elseitmay result in venous pulsation and inaccurate
measure of SpO
2
a nd pulse rate .
FFF
. Excessive ambient light may affect the measuring result. It includes fluorescent lamp, dual ruby
light, infrared heater, direct sunlight and etc.
GGG
. Strenuous action of the subject or extreme electrosurgical interference may also affect the
accuracy.
HHH
. Testee can not use enamel or other makeup.
III
. Please clean and disinfect the device after operating according to the User Manual( 7 .1).
666
.3.3.3
Clinical
Clinical
Clinical
restrictions
restrictions
restrictions
A. As the measure is taken on the basis of arteriole pulse, substantial pulsating blood flow of subject
is required. For a subject with weak pulse due to shock, low ambient/body temperature, major
bleeding, or use of vascular contracting drug, the SpO
2
waveform (PLETH) will decrease. In this case ,
the measurement will be more sensitive to interference.
BBB
. For those with a substantial amount of staining dilution drug (such as methylene blue, indigo
green and acid indigo blue), or carbon monoxide hemoglobin (COHb), or methionine (Me+Hb) or
thiosalicylic hemoglobin, and some with icterus problem, the SpO
2
determination by this monitor
may be inaccurate.
CCC
. The drugs like dopamine, procaine, prilocaine, lidocaine and butacaine may also be a major
factor blamed for serious error of SpO
2
measure.
DDD
. As the SpO
2
value serves as a reference value for judgement of anemic anoxia and toxic anoxia,
Page 15
12
some patients with serious anemia may also report good SpO
2
measurement.
777
Maintain
Maintain
Maintain
、 transportation
transportation
transportation
and
and
and
storage
storage
storage
777
.1.1.1
Cleaning
Cleaning
Cleaning
and
and
and
Disinfecting
Disinfecting
Disinfecting
Using medical alcohol to disinfect the device, nature dry or cleanitwith clean soft cloth.
777
.2.2.2
Maintain
Maintain
Maintain
A. Please clean and disinfect the device before using according to the User Manual( 7 .1).
B. Please recharge the battery when the screen shows , or else the device will power off
automatically ifitdetects the shortage of power .
C.C.C.
Recharge the battery soon after the over-discharge. The device should be recharged every six
months whenitis no regular used. It can extend the battery life following this guidance.
D. The device needs to be calibrated once a year (or according to the calibrating program of hospital).
It also can be performed at the state-appointed agent or just contact us for calibration.
777
.3.3.3
Transportation
Transportation
Transportation
and
and
and
storage
storage
storage
A. The packed device can be transported by ordinary conveyance or according to transport contract.
The device 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: - 4 0 ° C~ 60 ° C ; Humidity: ≤ 95 %
888
Troubleshooting
Troubleshooting
Troubleshooting
Trouble
Trouble
Trouble
Possible
Possible
Possible
Reason
Reason
Reason
Solution
Solution
Solution
ThThTh
eee
SpO
SpO
SpO
222
and
and
and
Pulse
Pulse
Pulse
Rate
Rate
Rate
can
can
can
not
not
not
bebebe
displayed
displayed
displayed
normally
normally
normally
1.
The finger is not properly positioned.
2. The patient’s SpO
2
is too low to be
detected.
1. Place the finger properly and try again.
2. Try again; Go to a hospital for a
diagnosis if you are sure the device
works all right.
The
The
The
SpO
SpO
SpO
222
and
and
and
Pulse
Pulse
Pulse
Rate
Rate
Rate
are
are
are
not
not
not
display
display
display
ededed
stabl
stabl
stabl
yyy
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
The
The
device
device
device
can
can
can
not
not
not
bebebe
turn
turn
turn
ededed
ononon
1. The batteries are drained or almost
drained.
2 . The device’s malfunction
1. Please recharge the battery
2. Please contact the local service center.
The
The
The
display
display
display
isisis
off
off
off
suddenly
suddenly
suddenly
1. The device’s malfunction .
2. The batter y is drained away or almost
drained away .
1. Please contact the local service center.
2. Please recharge the battery
The
The
The
device
device
device
can
can
can
not
not
not
bebebe
used
used
used
for
for
for
full
full
full
time
time
time
after
after
after
chagre
chagre
chagre
1 、 The battery is not full charged.
2 、 The battery is broken
1 、 Please recharge the battery
2 、 Please contact the local service center.
The
The
The
battery
battery
battery
can
can
can
not
not
not
bebebe
full
full
full
charged
charged
charged
even
even
even
after
after
after
101010
hours
hours
hours
charg
charg
charg
The battery is broken
Please contact the local service center.
Page 16
13
999
Key
Key
Key
ofofof
Symbols
Symbols
Symbols
101010
Function
Function
Function
Specification
Specification
Specification
ing
ing
ing
time.
time.
time.
Signal
Description
Warning – S ee User Manual
T he pulse oxygen saturation(%)
Pulse rate (bpm)
Full-voltage
Low-voltage
Close the alarm sound indication
Open the alarm sound indication
Close the pulse sound indication
Open the pulse sound indication
menu button /p ower button / function button
T
ype BF
SN
Serial number
1. the finger clip falls off ( no finger inserted) ]
2. Probe error
3. Signal inadequacy indicator
IPX1
Ingress of liquids rank
WEEE (2002/96/EC)
Information
Information
Information
Disp
Disp
Disp
lalala
yyy
Mode
Mode
Mode
The Pulse Oxygen Saturation （ SpO
2
）
2-digit digital OLED display
Pulse Rate （ PR ）
3-digit digital OLED display
Page 17
14
Pulse Intensity (bar-graph)
bar-graph OLED display
SpSpSp
OOO
222
Parameter
Parameter
Parameter
Specification
Specification
Specification
Measuring range
0 % ～ 100 %, (the resolution is 1%).
Accuracy
7 0% ～ 100 % ： ± 2% ,Below 70% unspecified.
Pulse
Pulse
Pulse
Parameter
Parameter
Parameter
Specification
Specification
Specification
Measuring range
25 bpm ～ 2 5 0 bpm, (the resolution is 1bpm)
Accuracy
± 2bpm or ± 2% (select larger)
Safety
Safety
Safety
Type
Type
Type
Interior Battery ，ＢＦ Type
Pulse
Pulse
Pulse
Intensity
Intensity
Intensity
Range
Continuous bar-graph display, the higher display indicate the
stronger pulse .
Battery
Battery
Battery
Requirement
Requirement
Requirement
V oltage 3.7 rechargeable lithium batte ry × 1
Battery
Battery
Battery
working
working
working
life
life
life
Charge and discharge no less than 500 times.
Dimensions
Dimensions
Dimensions
and
and
and
Weight
Weight
Weight
Dimensions
61(L) × 56(W) × 24 (H) mm
Weight
About 50g (with the lithium battery*1)
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