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 sa fety procedures to protect both the user and
equipment. Refer 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.
This product is medical device, which can be used repeatedly.
WARNING:
WARNING:
WARNING:
Uncomfortable
Uncomfortable
Uncomfortable
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
microcirculation
microcirculation
microcirculation
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.
For
For
For
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.
The
The
The
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.
The
The
The
light
light
light
(the
(the
(the
infrared
infrared
infrared
isisis
invisible)
invisible)
invisible)
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
caution.
caution.
caution.
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
CCC
ontents
ontents
ontents
1Safety
1Safety
1Safety
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111
1.1Instructionsforsafeoperations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.2Warning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.3Attention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
2.Overview
2.Overview
2.Overview
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222
2.1Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
2.2Majorapplicationsandscopeofapplication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
2.3Environmentrequirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
3.Principle
3.Principle
3.Principle
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333
4.Technicalspecifications
4.Technicalspecifications
4.Technicalspecifications
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333
4.1Mainperformance
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3
4.2MainParameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
5Installation
5Installation
5Installation
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444
5.1Viewofthefrontpanel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
5.2Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
6OperatingGuide
6OperatingGuide
6OperatingGuide
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555
6.1Applicationmethod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
6.2Attentionforoperation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
6.3Clinicalrestrictions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
7Maintain
7Maintain
7Maintain
、 transportationandstorage
transportationandstorage
transportationandstorage
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101010
7.1CleaningandDisinfecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
7.2Maintain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
7.3Transportationandstorage
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11
8Troubleshooting
8Troubleshooting
8Troubleshooting
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111111
9KeyofSymbols
9KeyofSymbols
9KeyofSymbols
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121212
10FunctionSpecification
10FunctionSpecification
10FunctionSpecification
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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 using 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.
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.
1.1.1.
333
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
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
Page 5
2
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.
2.2.2.
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
2.2
2.2
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.
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.
Page 6
3
2.3
2.3
2.3
Environment
Environment
Environment
requirements
requirements
requirements
Storage Environment
a) Temperature : - 40 ℃ ～ + 60 ℃
b ) Relative h umidity : 5 % ～ 95 %
c ) Atmospheric pressure : 500h Pa ～ 106 0h Pa
Operating Environment
a) Temperature : 0 ℃ ～ 5 0 ℃
b ) Relative Humidity : 15 % ～ 95 %
c ) Atmospheric pressure: 700h Pa ～ 106 0h Pa
3.3.3.
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 Characteristics of Reductive
Hemoglobin ( Hb ) and Oxyhemoglobin ( Hb O2) in glow & near-infrared zones. Operation principle of
the device is: Photoelectric Oxyhemoglobin Inspection Technology 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 perspective clamp finger-ty pe 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.
4.4.4.
Technical
Technical
Technical
specifications
specifications
specifications
4.1
4.1
4.1
Main
Main
Main
performance
performance
performance
A.A.A.
SpO
2
value display
B.B.B.
P ulse rate value display , bar graph display
C.C.C.
Pulse waveform display
D.D.D.
L ow-voltage indicat ion: low-voltage indicator appears before working abnormally which is due
to low-voltage
E.E.E.
The display mode can be changed
F.F.F.
Screen brightness can be changed
G.G.G.
A
pulse sound indicat ion
HHH
...
With alarm function
III
...
With SpO
2
value and pulse rate value of storage, the stored data can be uploaded to computers
JJJ
...
It can be connected with an external oximeter probe
KKK
...
Real-time data can be transmitted to computers
Page 7
4
4.2
4.2
4.2
Main
Main
Main
Parameters
Parameters
Parameters
A.A.A.
Measurement
Measurement
Measurement
ofofof
SpO
SpO
SpO
222
Measur ing range: 0 % ～ 100 ％
Accuracy:
When the SpO
2
measuring 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
3.6
3.6
VVV
DCDCDC
~~~
4.2V
4.2V
4.2V
DC.
DC.
DC.
G.G.G.
Optical
Optical
Optical
Sensor
Sensor
Sensor
Red light (wavelength is 660nm ， 6.65mW)
Infrared (wavelength is 880 nm, 6.75mW)
555
Installation
Installation
Installation
5.1
5.1
5.1
View
View
View
ofofof
the
the
the
front
front
front
panel
panel
panel
Figure 2. F ront
V
iew
Page 8
5
5.2
5.2
5.2
Accessories
Accessories
Accessories
A.A.A.
A
lithium battery
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
6.1
6.1
6.1
Application
Application
Application
method
method
method
A.A.A.
a)a)a)
Open the lid of battery box and put the battery in side , then close.
b)b)b)
Put the suitable probe into the jack on the right side of the oximeter. (The probe is limited to be
produced by our company; never re placeitwith the similar ones by other manufacturers ).
c)c)c)
Put the finger into the probe .
d)d)d)
Press the "power on/off button" long about
a
few seconds,the power is on,and the device will
start to self-inspect .The device displays the measuring interface after self-inspect ing.
e)e)e)
Do not shake the finger and keep the patient inastable state during the process.
f)f)f)
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 3.
（ Actual probe may be different with the probe as figure 3,please accept the actual probe with the
device ）
B.B.B.
Change
Change
Change
display
display
display
direction:
direction:
direction:
On the measuring interface, press the"screen change button"can change the display direction.
C.C.C.
Pause
Pause
Pause
alarm:
alarm:
alarm:
Page 9
6
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.
b)b)b)
When alarm is on,press the"alarm pause button"can pause the alarm,it can renew alarm in about
60s,and if pressing the"alarm pause button" Again with in 60s,it can renew alarm .
c)c)c)
If you want to turn off the alarm for good, you should enter the menu for operation.
D.D.D.
Menu
Menu
Menu
operations:
operations:
operations:
On the measuring interface,press the"menu button"can enter the menu of figure 4.Users can adjust
the setting through the main menu, such as alarm, pulse sound indication, backlight,data storage,data
transmission (with the use of data line),the specific method is as follows:
Figure 4. Main Menu Interface
a)a)a)
Alarm
Alarm
Alarm
setting
setting
setting
On the main menu interface,press the"up button"or"down button",move the menu choice bar to
" Alarm " ,then press the"menu button"to enter the alarm setting menu of figure 5:
Figure 5. Alarm Setting Menu
a.a.a.
The
The
The
highest/lowest
highest/lowest
highest/lowest
alarm
alarm
alarm
limit
limit
limit
setting
setting
setting
Press the"up button"or"down button" to choose the parameter to be adjusted , then press the"menu
button"again to enter the similar dialog box shown as figure 6,then press the"up button"or"down
button"to change data. Each p ress of the"up button"or"down button" , the data will raise or descend
for one time accordingly , untilitgets to the required number , then press the "menu button"for
another time to end the set ting .
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.
Page 10
7
Figure 6.
b.b.b.
The
The
The
aaa
larm
larm
larm
state
state
state
setting
setting
setting
Press the"up button"or"down button", move the menu choice bar to " Alarm ", then choose the alarm
state (on/off) by pressing the "menu button" , choose “ on ” to start the alarm function, and choose “ off ”
to closeitfor good.
b)b)b)
Pulse
Pulse
Pulse
sound
sound
sound
indication
indication
indication
setting
setting
setting
On the main menu interface,press the"up button"or"down button",move the menu choice bar to"Pulse
Sound", then choose the pulse sound indication state (on/off) by pressing the "menu button" ,press
“ on ” to start the function, and press “ off ” to close it.
c)c)c)
Backlight
Backlight
Backlight
adjustment
adjustment
adjustment
On the main menu interface,press the"up button"or"down button",move the menu choice bar to
" Brightness ",then press the"menu button" to change the number in order to adjust the brightness of
screen.
d)d)d)
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,press the"up button"or"down button",move the menu choice bar
to" Record",then press the"menu button"again to enter the dialog box of figure 7:ifitis in recording
state,the"Stop"is displayed on menu;ifitis not in recording state,the" Start "is displayed on menu.
Figure 7.
b.b.b.
When the" Start "is displayed on the menu,if the memory still have the former data in storage ,the
" Do you really want to recover the memory" dialog box will be displayed when pressing the
"menu"button ,then press the"up button"or"down button"to choose setting,then press the"menu
button"to confirm setting,the dialog box will be displayed as figure 8:It needs to set the starting time
for data storage by users , users can change the setting value by pressing the"up button"or"down
button",and confirm the setting value by pressing the"menu button", the black cursor will move to
Page 11
8
next place after setting.When the black cursor move to"Y es"(store) or "No"(don't store), press the"up
button"or"down button"to choose setting,then press the"menu button"to confirm setting.
c.c.c.
When the" Stop "is displayed on menu,the ＂ Do you really want to stop recording ＂ dialog box
will be displayed when pressing the "menu button".then press the"up button"or"down button"to
choose setting,then press the"menu button"to confirm setting.
Figure 8.
d.d.d.
If the data storage function is being turned on, when return to the measuring interface,ared
"REC"sign and
a
flashing red dot would appear on screen, which means the device is in
a
state of
storing.
e.e.e.
In the state of storing, whatever interface the device is on (measuring interface, menu interface),
the sign "Recording" would appear on the screen in 30 seconds, and then the screen will be
automatically shut down. If pressing any button(power on/off e xcluded) at this moment, the sign
"Recording" would appear on the screen, and then the screen will be automatically shut down again; if
pressing the "power on/off button", the device would return to the former interface.
f.f.f.
I f turning on the data storage function, the former data storage will be automatically removed.
g.g.g.
In the state of data storing, after the screen is automatically shut down, the pulse sound indication
would be off for saving power.
h.h.h.
When 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 any button(power on/off excluded) again,
it
will enter the
measuring interface.
eee
） Stored
Stored
Stored
data
data
data
transmission
transmission
transmission
setting
setting
setting
Firstly, please install the affiliated software into the computer, and then two icons would appear on
the desktop after installation. The icon of SpO2 isaprogram for receiving real-time data which is
shown as figure 9 ; the icon of SpO2 Review isaprogram for receiving stored data which is shown as
figure 10 .
Figure 9.SpO2 program
Figure 10. SpO2 Review program
a.a.a.
Please connect the device to computer with the affiliated data line , then double click" SpO2
Page 12
9
Review"icon to start the program .
b.b.b.
On the main menu interface,press the"up button"or"down button" in order to move the menu
choice bar to" Upload", then press the"menu button"to transmit the stored data to computer for replay
and analysis.
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 stored data is being uploaded ,the screen displays as figure 11.
Figure 11.
e.e.e.
When the upload of stored data is finished, the device will automatically return to the main menu,
and the menu choice bar will move to "Exit"automatically as well.
fff
） Exit
Exit
Exit
the
the
the
main
main
main
menu
menu
menu
On the main menu interface,press the"up button"or"down button" in order to move the menu choice
bar to"Exit",then press the"menu button"to exit the main menu.
E.E.E.
Real-time
Real-time
Real-time
data
data
data
transmission
transmission
transmission
a)a)a)
Please connect the device with computer by the data line which is equipped with the device,then
double click "SpO2"icon to open"SpO2"program.
b)b)b)
The data can be displayed on computer screen inafew seconds.
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.
F.F.F.
Charge
Charge
Charge
There are two kinds of charging methods:
a)a)a)
Connect the device with computer by data line, then the device should be under charging state.
b)b)b)
Connect the device with power supply by power adaptor, then the device should be under
charging state.
c)c)c)
The five status of b attery power are shown as follows:
Power supply by battery only , and battery status is full
Battery status is not full
Battery status is draining away
the four status above shows
dynamically in turn
Battery is under charging
Page 13
10
ddd
） When charging the battery in the state of power off, the sign of battery status still exists on the
screen, but
it
will disappear in about 60 seconds for saving power. However, the sign will appear
again if you press any button(power on/off excluded) at t his moment.
IfIfIf
the
the
the
alarm
alarm
alarm
function
function
function
isisis
ononon
,,,
the
the
the
device
device
device
will
will
will
provide
provide
provide
high-priority
high-priority
high-priority
alarm
alarm
alarm
signal
signal
signal
when
when
when
the
the
the
battery
battery
battery
isisis
ininin
low
low
low
power
power
power
status
status
status
and
and
and
intermittent
intermittent
intermittent
alarm
alarm
alarm
will
will
will
occur.
occur.
occur.
6.2
6.2
6.2
Attention
Attention
Attention
for
for
for
operation
operation
operation
A.A.A.
Please check the device before using, and confirm thatitcan work normally.
BBB
. The finger should be inaproper position (see the attached illustration of figure 3 for reference), or
elseitmay result in inaccurate measure.
C.C.C.
The SpO
2
sensor and photoelectric receiving tube should be arranged inaway with the subject’s
arteriole inaposition there between .
DDD
...
The SpO
2
sensor should not be used atalocation 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).
6.3
6.3
6.3
Clinical
Clinical
Clinical
restrictions
restrictions
restrictions
A.A.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 asareference value for judgement of anemic anoxia and toxic anoxia,
some patients with serious anemia may also report good SpO
2
measurement.
777
MMM
aintain
aintain
aintain
、 transportation
transportation
transportation
and
and
and
storage
storage
storage
7.1
7.1
7.1
Cleaning
Cleaning
Cleaning
and
and
and
Disinfecting
Disinfecting
Disinfecting
Using medical alcohol to disinfect the device, nature dry or cleanitwith clean soft cloth.
7.2
7.2
7.2
Maintain
Maintain
Maintain
A.A.A.
Please clean and disinfect the device before using according to the User Manual(7.1).
Page 14
11
B.B.B.
Please recharge the battery when the screen shows .
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.D.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.
7.3
7.3
7.3
Transportation
Transportation
Transportation
and
and
and
storage
storage
storage
A.A.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.B.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
The
The
The
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 battery is drained away or almost
drained away .
2 . The battery is installed incorrectly.
3. The malfunction of the device.
1.
Please recharge the battery
2.
Please Install the battery again.
3 . Please contact the local service
center.
The
The
The
display
display
display
isisis
off
off
off
suddenly
suddenly
suddenly
The battery is drained away or almost
drained away .
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
charge
charge
charge
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
charging
charging
charging
time.
time.
time.
The battery is broken
Please contact the local service
center.
Page 15
12
999
Key
Key
Key
ofofof
Symbols
Symbols
Symbols
Signal
Description
Warning – See User Manual
The pulse oxygen saturation(%)
Pulse rate (bpm)
Close the alarm sound indication
Open the alarm sound indication
Close the pulse sound indication
Open the pulse sound indication
Power on/off button
Alarm pause button/up button
Menu button
Screen change button/down button
Type 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)
Page 16
13
101010
Function
Function
Function
Specification
Specification
Specification
Information
Information
Information
Display
Display
Display
Mode
Mode
Mode
The Pulse Oxygen Saturation （ SpO
2
）
2-digit digital OLED display
Pulse Rate （ PR ）
3-digit digital OLED display
Pulse Intensity (bar-graph)
bar-graph OLED display
SpO
SpO
SpO
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 0bpm, (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 battery × 1
Batter
Batter
Batter
yyy
working
working
working
life
life
life
Charge and discharge no less than 500 times.
Dimensions
Dimensions
Dimensions
and
and
and
Weight
Weight
Weight
Dimensions
87 ( L ) × 45 ( W ) × 22 ( H ) mm
Weight
About 180 g (with the lithium battery *1 )
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