PROFESSIONAL MEDICAL PRODUCTS
OXY-200 PULSE OXIMETER
35101 / CMS70A
CONTEC MEDICAL SYSTEMS CO., LTD
No.112 Qinhuang West Street,
Economic & Technical Development Zone,
066004 Qinhuangdao, Hebei Province,
PEOPLE’S REPUBLIC OF CHINA
Made in China
Shanghai International Holding Corp. GmbH (Europe)
Eiffestrasse 80, 20537 Hamburg, Germany
Imported by:
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
M35101-GB-Rev.2-02.20
0123
IP21
I
Instructions to User
Dear users, thank you very much for purchasing the device.
This Manual is written and compiled in accordance with the council directive MDD93/42/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 device’s fea tures an d r equirem ent s, mai n s truc tur e,
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. Refer to the respective chapters for details.
Please read the User Manual carefully before using this product. The User Manual which
describes the operating procedures should be followed strictly. Failure to follow the User Manual
may cause measure 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 users' negligence of the operation instructions.The
manufactu rer’s warra nty service does not cover su ch faults.
Owing to the forthcoming ren ovation, 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.
WA R N I N G :
M Uncomfortable or painful feeling may appear if using the device ceaselessly, especially
for the microcirculation barrier patients. It is recommended that the device should not
be applied to the same finger for over 2 hours.
M For the special patients, there should be a more prudent inspecting in the placing
process. The device can not be clipped on the edema and tender tissue.
M The light (the infrared is invisible) emitted from the device is harmful to the eyes, so the
user and the maintenance man should not stare at the light.
M Te st ee ca n n ot u se en a me l o r ot he r m ak e up .
M Te stee’s fingernail can not be too long.
M Please refer to the correlative literature about the clinical restrictions a nd caution.
M This device is not intended for treatment.
The User Manual is published by our c ompany. All r ights reserved.
II
Contents
1 Safety ............................................................................................................................... 1
1.1 Instructions for Safe Operation ........................................................................... 1
1.2 Wa rn i ng ................................................................................................................ 1
1.3 Attention ............................................................................................................... 1
1.4 EMC Statement .................................................................................................... 2
2 Overview ......................................................................................................................... 3
2.1 Features................................................................................................................. 3
2.2 Major Applications and Scope of Application ................................................... 3
2.3 Contraindications ................................................................................................. 3
3 Principle .......................................................................................................................... 4
4 Te ch n ic al Specifications............................................................................................... 4
4.1 Main Performance................................................................................................ 4
4.2 Main Parameters .................................................................................................. 5
4.3 Envir onment Requirements ................................................................................. 5
5 Installation ...................................................................................................................... 6
5.1 View of the Front Panel ....................................................................................... 6
5.2 View of the Back Panel ....................................................................................... 7
5.3 Accessories ........................................................................................................... 7
6 Operating Guide ........................................................................................................... 8
6.1 Application Method ............................................................................................. 8
6.2 Attention for Operation ..................................................................................... 15
6.3 Clinical Restrictions........................................................................................... 16
7 Maintenance,Transportation and Storage ............................................................ 16
7.1 Cleaning and Disinfecting ................................................................................. 16
7.2 Maintenance ....................................................................................................... 16
7.3 Transportation and Storage ............................................................................... 16
8 Troubleshooting ........................................................................................................... 17
9 Key of Symbols .......................................................................................................... 18
10 Function Specification ............................................................................................. 20
11 Factory Defa ult ......................................................................................................... 21
Appendix I ......................................................................................................................... 22
1
1 Safety
1.1 Instructions for Safe O peration
² 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 the
device.
² Necessary maintenance must be performed by qualified service engineers ONLY. Users are
not permitted to maintain it by themselves.
² If the battery has to be replaced, the battery shall be provided by manufacture and replaced
only by trained service personnel.Incorrect replacement and model of battery may cause
device damage and patient injury.
² The device can't be used together with devices not specified in User Manual.Only the
accessory that is appointed or recommendatory by manufacture can be used with this device.
² This product is calibrated before leaving factory.
² Users should have basic text distinguish ability.
² The patient is also an intended operator.Patient can use the device for measurement, storage
and data upload. While device maintenance, clean or batteries replacement is not allowed.
² During normal use，please do not position this device to make it difficult to disconnect form
power supply.
² After use,please switch off and unplug the device.
1.2 War nin g
M Don't open the enclosure of the device to avoid tip-and-run danger.Necessary maintenance
and upgrade must be performed by qualified serv ice engineers who have been trained and
accredited by our company ONLY
M Explosive hazard—DO NOT use the device in the environment with tinder such as
anesthetic .
M DO NOT use the device while the patient is being scanned by MRI or CT.
M The disposal of scrap instrument and its accessories and packing (including battery, plastic
bags, foams and paper boxes) should follow the local laws and regulations,and place them in
the place where the children can't reach.
M 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.
M Please choose the accessories and probe which are approved or manufactured by the
manufactu rer, or else it may damage the device.
M The device can only be matched with the c ompatible probe.
M Please don't measure this device with functional tester for the device's related information.
M Parts of this device are not allowed to be serviced or maintained while in use with the patient.
1.3 Attention
% Keep the device away from dust, vibration, corrosive substances, tinder, high temperature and
moisture.
% If the device gets wet, please stop operating it.
2
% 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 device is not permitted. Refer to
User Manual in the relative chapter (7.1) for instructions of cleaning and disinfection.
% DO NOT have the device 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℃.
% The fingers which are too thin or too cold may affect the measure accuracy, please clip the
thicker finger such as thumb and middle finger deeply enough into the probe.
% The device can be u sed to adult and child.Whether the device is used to adult or children, 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 measure value when the waveform on screen is equably and steady-going.This
measure value is optimal value,and the waveform at the moment 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 life for three years.
% The device has alarm function, users can check on this function according to chapter 6.1 as
reference.
% The device has the function of limit alarm.When the measure data is beyond limit, the device
would start to alarm automatically if the alarm function is on.
% The device has alarm function.This function can either be paused, or closed for good.Please
check the chapter 6.1 as reference.
% The device may not w ork for all patients.If you are unable to achieve stable readings,
discontinue use.
1.4 EMC Statement
Electromagnetic compatibility shall be considered during device in use, because high
electromagnetic portable or mobile RF equipment will interfere the working of the device.
Usage of other cables will affect the EMC performance of the device, please use the standard
accessories.
3
2 Overview
The pulse oxygen saturation is the percentage of HbO
O
concentration in the blood. It is an important bio-parameter for the respiration. A numb er of
2
diseases relating to respiratory system may cause the decrease of SpO2 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 corresponding 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' SpO2 is of great help for the doctor to discover the
potential danger, and is of great importance in the clinical medical field.
The device is fashion and portable.It is only necessary for patient to put one finger into probe for
diagnosis,and display screen will directly show the measure value of pulse oxygen saturation
with the high veracity and repetition.
2.1 Features
A Operation is simple and convenient.
B Product is handsome and fashion,and easy to observe
C With two kinds of power supply mode(alternating current and internal electrical power source)
2.2 Major Applications and Scope of Application
The device can be used in measuring the pulse oxygen saturation and pulse rate through finger.
The product is suitable for being used in family, hospital, oxygen bar, 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.
2.3 Contraindications
The problem of overrating would emerge when t he patient is suffering from toxicosis
which caused by carbon monoxide,and the device is not recommended to be used under
this circumstance.
The person who is allergic to rubber can not use this device.
in the total Hb in the blood, s o-called the
2
4
3 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 (HbO2) 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-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.
4 Technical Specifications
4.1 Main Performance
l SpO2 value display
l Pulse rate value display, bar graph display
l PI value display
l Pulse waveform display
l Battery power display
l Low-power indication: low-power indication symbol appears before working abnormity
which is due to low-power.
l Review function
l Screen brightness can be adjusted
l Volume can be adjusted
l Display mode can be adjusted
l Pulse sound indication
l With alarm function,the user c ould set alarm limit.
l With real-time data uploading function.
l With clock function
l With two kin ds of power supply mode(alternating current and internal electrical power
5
source)
4.2 Main Parameters
A Measure of SpO2
Measure range: 0~100%
Accuracy:
When the SpO2 measu re range is 70%~100%,the permission of absolute error is ±2%;
Below 70% unspecified.
B Measure of pulse rate
Measure range:30bpm~250bpm
Accuracy: ±2 bpm or ±2% (select larger)
C Measure of PI
Range: 0~20%
When the PI measure range is 1%~20%,the permission of absolute error is ±1%
When the PI measure range is 0%~0.9%,the permission of absolute error is ±0.2%;
D Resolution
SpO2 : 1%
Pulse rate: 1bpm
PI: 0.1%
E Measure performance in weak filling condition:
SpO2 and pulse rate value can be shown correctly when pulse-filling ratio is 0.4%. SpO2
error is ±4%; pulse rate error is ±2 bpm or ±2% (select larger).
F Resistance to surrounding 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%.
G Power supply requirement:
Alternating current supply:100～240V AC 50/60Hz
Internal electrical power source:3.6 V DC ~4.2V DC.
H Optical sensor
Red light (wavelength is 660nm,6.65mW)
Infrared (wavelength is 880nm, 6.75mW)
I Adjustable alarm range:
SpO2 : 0~100%
Pulse Rate: 0bpm~254bpm
4.3 Environment Requirements
Storage Transportation Environment
a) Temp er atu re :-40℃~60℃
b) Relative humidity :≤95%
c) Atmospheric pressure :500hPa~1060hPa
Operating Environment
a) Temp er atu re :0℃~40℃
b) Relative Humidity :≤75%
c) Atmospheric pressure:700hPa~1060hPa
6
5 Installation
5.1 View o f the Front Panel
Figure 2. Front view
Alternating current indicator lint:the light is green when powered on.
Probe jack : it is used to connect Oximeter probe to measure the oxygen saturation,pulse rate and
PI.
Display area: display measure information
Button Area:
1 Mode switch button:click it to switch mode (Measure interface 1 / Measure interface 2)
2 Alarm pause button:when alarm happens,press it to make alarm sound pause.The pause time
could be set by menu.
3 Return button:return to the previous menu.
4 Up button/down button/left button/right button:change the choice bar position left/right button:
set part function
5 Menu button:in waveform measure interface,press the button to enter the menu setting;in menu
interface,press the button to enter the corresponding submenu.
6 Power button:in power-off state,long press the button to turn on the device;in power-on
state,long press the button to turn off the device.
7
5.2 View of the Back Panel
Figure 3. Back view
USB port :It is used to connect computer to transmit data by data line.
R pinhole Restoration key:restore the device.
The computer intended to be connected with this device,shall be approved and certificated
according to IEC 60950.
During data transmitting,please do not use this device with patient.
Power supply jack:power supply line interface
5.3 Accessories
A A User M anu al
B A p owe r su pply line
C A d ata li ne
D An Oximeter probe
Optional:
A Other Oximeter probe (refer to <Probe Application Introduction>)
8
6 Operating Guide
6.1 Application Method
6.1.1
Inserting the lemo probe into the lemo jack of the device (The probe is limited to the one that is
provided by our company; and can't be replaced with the similar one by other
manufactu rers),then put the finger into the probe as Figure 4.
Figure 4. Probe connecting
A Long press power button until the device is turned on.If use alternating current,make sure that
the power supply line is connected accurately.
B Do not shake the finger and keep the patient in a stable state during the process.
C The data can be read directly from the screen in the measure interface.
Fingernails and the luminescent tube should be at the same side.
If the alarm function is on, the device will provide alarm signal when probe or finger
is out.
6.1.2 Alarm pause
A Alarm including the alarm of measure data's going beyond the limits, the alarm of low-voltage,
the alarm of finger out.
B When alarm is on,short press the alarm pause button to make the alarm pause, it can renew
alarm after period of time, alarm pause time can be set by menu.
C Only alarm sound can be closed,the prompt information displayed can't be closed.
6.1.3 Menu operations
In the measuring interface, press menu button to enter the main menu interface as figure 5.
9
Figure 5. Main menu interface
System setting
In the main menu interface, choose "System" item, then press menu button to enter the System
setting menu as figure 6:
Figure 6. System setting menu
A Volume:move the choice bar to the "Volume" item, then press left/right button to set the
volume (three levels,OFF means closing sound).
B Pulse sound:move the choice bar to the "Pulse sound" item, then press left/right button to set
pulse sound.
C key sound:move the choice bar to the "key sound" item, then press left/right button to set key
sound.
D Ve r s i o n :move the choice bar to the "Version" item,then press the menu button to see the
edition information of hardware and software,and return to the system setting menu interface
after 2 seconds .
E Equipment ID: see the ID information of device.The ID of the device can be set by the PC
software.Please refer to <SpO2 Assistant user manual> for detail.
F Factory Default: move the choice bar to the "Factory Default" item,then press the menu button
to pop-up "Factory Default" window.Press up/down button to choose whether to resume
Factory Default,and press menu button to affirm setting,then press return button to return the
system setting menu interface.
Display setting
In the main menu interface, choose "Display" ite m, then press menu button to enter the display
10
setting menu as Figure 7:
Figure 7. Display setting menu
A Brightness: move the choice bar to the "Brightness" item,then press left/right button to set
(three levels)
B Mode: move the choice bar to the "Mode" item,then press left/right button to switch display
mode (two kinds of display mode) as figure 7 and figure 8.
Note:in measure interface,the user could press mode switch button to switch display mode
too.
Figure 8. Interface 1 Figure 9. Interface 2
C LCD ON:mov e the ch oice bar t o the "LCD ON" item,then press left/right button to set display
time (range:1~60min) .0 means display at all times
D Demo:move the choice bar to the "Demo" item,then press left/right button to turn on/off demo
function.
E Theme: move the choice bar to "Theme" item, then press left/right button to set theme（Three
kinds of theme are optional.)
Clock setting
In the main menu interface, move the choice bar to "Clock" item, then press the menu button to
enter the clock setting menu of Figure 10:
11
Figure 10. Clock setting menu
Move the choice bar to the menu item that you want to set, and press left/right button to begin to
set.After resetting time,press return button to return to the main menu.
Alarm setting
In the main menu interface, move the choice bar to "Alarm" item, then press menu button to
enter the alarm setting menu of Figure 11.
Figure 11. Alarm setting menu
A Set the high/low limit of alarm
In alarm setting menu,you can set the high/low limit of alarm.Move the choice bar to the menu
item that you want to set, and press left/right button to set value,then press menu button for
affirming.
If the alarm function is on, the device will provide alarm sound when the measure
value is beyond the limit.
B Set alarm state
In alarm setting menu,move the choice bar to the "Alarm" item, press left/right to set the alarm
state.Choose "on" to turn on the alarm, and choose "off" to turn off the alarm.
C Set alar m pause time
In alarm setting menu,move the choice bar to the "Alarm Pause" item, then press left/right to
set the alarm pause time.The range is 10~180s.
Record setting
In the main menu interface, move the choice bar to "Record" item,then press menu button to
enter record menu as Figure 12.
12
Figure 12. Record Menu
A Record setting
a In the record menu interface, move the choice bar to "Record" item, then press left/right button
to choose on/off.When displaying "on",press menu button enter the input ID interface as
Figure 13. When recording, choose "off",and press menu button to stop recording.
Figure 13. Input ID interface
b In "Input ID" interface,aglimmer cursor appears in the ID input box.The pink letter is the
selected letter in dummy keyboard.Press direction key to choose the letter to input and press
menu button to input.You c an i np u t 4 le t te rs m ost. choose ,then press menu button to
delete letter.After inputting,choose ,then press menu button to begin to record data and
return to measure interface.
c If the inputed ID has existed,the prompt dialog box as figure 14 will appear.Choose "Yes" and
click menu button to replace the existed ID , at the same time begin to record and return to
the measure interface;choose "No" to return the "Input ID" interface.
13
Figure 14. Replace the existed ID dialog box
d Every patient ID could save 24-hour data,the device could save 16 patient ID.
e When the memory is full,the system will stop recording automatically.
f When the 16 groups of ID all have data,click "record" menu again,the device will appear "No
Memory" dialog box.After deleting ID,the record can be continued.
If the device is restarted in the process of recording,the device will lose the segment of
recording data.
In the process of recording,don't allow deleting and reviewing recording information.
B Memory Manager setting
In the Record menu interface,move the choice bar to the "Memory Manager" item,then press
menu button to enter ID Manager interface as figure 15.
Figure15. ID Manager interface
In ID Manager interface,press direction button to choose ID or "Delete ID",and press menu
button to prompt deleting operation as figure 16.Choose "Yes" and press menu button to delete
ID.Choose "No" to return to the memor y manager interface.
14
Figure 16. Delete ID dialog box
C Review function setting
In record menu interface,move the choice bar to the "Review" item,then choice frame will
appear.Press the "left/right button" to choose "VALUE"/"TREND",then press menu button to
enter "select ID" interface as figure 17.
Figure 17. Select ID interface
Choose the review record and press menu button to enter the review interface.Choose "VALUE"
to enter true value review interface as figure 18.Choose "TREND" to enter trend review interface
as figure 19.
Figure 18. VALUE review interface Figure19. TREND review interface
In value review mode,press "left button" or "right button" to page up or page down,press "up
button" or "down button" to page up or page down quickly.The displayed time on the right top is
the total recording time.
15
In trend review mode ,the pink number on the left bottom is current recording time point of the
trend graph,the middle azury font is SpO2 value,yellow font is pulse rate value,the green front on
the right bottom is PI value.Press "up button" or "down button" to page up or page down;press
"left button" or "right button" to move the recording time which is denoted by pink triangle.
Close the device
a In the main menu interface, move the choice bar to the "Power " item,then press menu button
to c lose the device.If the record function has been opened,the prompt interface of
"Recording..." will appear when closing the device.It means that the device is in the record
state,can't be closed.
b In the state of boot-strap,long press power button could close the device too.
6.1.4 PC software operation
Please connect the device to the computer by data line, then double click "SpO2 Assistant" icon
to run the PC software.The functions such as uploading real time/memory data and change
device ID could be carried out by the software.Please refer to <SpO2 Assistant user manual> for
detail.
If the users choose to turn on the display function on computer, it would probably take
several seconds for the data to appear on the computer screen.(If there is no data on the
computer screen ,unplug data line,then repeat step E again .)
6.1.5 Charge
Connect the device to power supply with power line.
When the device is closed and the battery is charging up,short press power button and the
device will display dynamic charge icon ,it means that the device is charging up.When the
battery status is full,the charging has been finished.When the device is op en and the battery is
charging up,the battery status icon on the right top will display dynamically.It means that the
device is charging up.When the battery status is full,the charging has been finished.
6.2 Attention for Operation
A lease check the device before use, and confirm that it can work normally.
B The finger should be in a proper position (see the attached illustration of Figure 4 for
reference), or else it may result in inaccurate measure.
C The ray between luminescent tube and photoelectric receiving tube must get across subject’s
arteriole.
D The device should not be used at a location or limb tied with arterial canal or blood pressure
cuff or receiving intravenous injection.
E Ensure nothing, such as a plaster, can impede the light passage., or else it may result in
inaccurate measure of SpO2 ,pulse rate and PI.
F Excessive ambient light may affect the measure result. It includes fluorescent lamp, dual ruby
light, infrared heater, direct sunlight and etc.
G Exquisite action of the subject or extre me electrosurgical interference may also affect the
accuracy.
16
H Tes tee can not us e e na mel o r oth er ma ke up.
I Please clean and disinfect the device after operating according to the User Manual (7.1).
6.3 Clinical 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 SpO2 waveform (PLETH) will
decrease. In this case, the measure will be more sensitive to interference.
B 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 thiosalicyl ic hemoglobin, and some with icterus problem, the SpO2 determination by this
device may be inaccurate.
C The drugs like dopamine, procaine, prilocaine, lidocaine and butacaine may als o be a major
factor resulted in serious error of SpO2 measu re.
D As the SpO2 value serves as a reference value for judgment of anemic anoxia and toxic anoxia,
some patients with serious anemia may also report good SpO2 measu re.
7 Maintenance,Transportation and Storage
7.1 Cleaning and Disinfecting
Using medical alcohol to disinfect the device, nature dry or clean it with clean soft cloth.
7.2 Maintenance
A Please clean and disinfect the device before use according to the User Manual (7.1).
B Please recharge the battery when the screen shows low power alarm information.
C Recharge the battery soon after the over-discharge. The device should be recharged every six
months when it is not regular used. It can extend the battery life following this guidance.
D Users are advised to calibrate the device termly (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 Tra nspor tat ion and 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.
Tem pera tur e: -40°C~60°C; Relative Humidity: ≤95%
17
8 Troubleshooting
Tro uble
Possible Reason
Solution
The SpO2 and
Pulse Rate can
not be displayed
normally
1.The finger is not properly
positioned.
2.The patient’s SpO2 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 SpO2 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 malfunction of the device.
1.Please recharge the battery
2. Please contact the local
service center.
The display is off
suddenly
1.The device is damaged.
2.The battery is drained away or
almost drained away.
1.Please contact the local
service center.
2.Please recharge the battery.
The device can
not be used for
full time after
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 battery can
not be full
charged even
after 10 hours
charging time.
The battery is broken
Please contact the local
service center.
18
9 Key of Symbols
Signal
Description
Follow instructions for use
The pulse oxygen saturation (%)
Pulse rate (bpm)
Perfusion Index (%)
The battery power is full
fall short of power little
Power is low
Power is not enough
Alarm indication: cyan-alarm on; yellow-alarm pause;white-alarm off
Pulse sound indication:cyan- on;white-off
Kinescope indication :when Kinescope-red; else circs-white
PR indication:when there is pulse jumpiness, it glitters and op
Finger out (no nger)
Power on/off button
Type BF applied part
R
Finger Out
SENSOR OFF
SENSOR
FAULT
USB
R pinhole Restoration key
Serial number
Probe error
Signal indication is not enough.
The sensor is off(probe-off)
Sensor fault(probe fault)
WEEE disposal
Authorized representative in the European community
19
Medical Device complies with Directive 93/42/EEC
Alternating current indicator light
Class II applied
IP21
Covering Protection rate
Manufacturer
Date of manufacture
Temperature limit
Atmospheric pressure limit
Humidity limit
This side up
Fragile, handle with care
Keep in a cool, dry place
Keep away from sunlight
Recovery
Product code
Caution: read instructions (warnings) carefully
20
10 Function Specification
Information
Display Mode
The Pulse Oxygen Saturation(SpO2)
2-digit digital LED display
Pulse Rate(PR)
3-digit digital LED display
Pulse Intensity (bar-graph)
8-segment light bar LED display
PI (perfusion index)
3-digit digital LED display
SpO2 Parameter Specification
Measuring range
0~100%, (the resolution is 1%).
Accuracy
70%~100%:±2% ,Below 70% unspecified.
Pulse Parameter Specification
Measuring range
30bpm~250bpm, (the resolution is 1bpm)
Accuracy
±2bpm or±2% (select larger)
Perfusion Index Specification
Range
0~20% (The resolution is 0.1%)
Pulse Intensity
Range
Continuous bar-graph display, the higher display
indicates the stronger pulse.
Safety Type
II genus, Interior Batter y,BF Ty pe
Battery Requirement
Vo lt a g e 3 . 7 re c h a r g e a b le l i t h i um b a t t e r y × 1 (The red wire on the battery denotes anode,the
black wire on the battery denotes cathode.)
Battery working life
Charge and discharge no less than 500 times.
Power Requirement
Input Voltage
AC 100 to 240V, 50/60 Hz
Dimensions and Weight
Dimensions
269(L) × 222(W) × 79(H) mm
We ig h t
About 1kg (with a lithium battery)
21
11 Factory Default
default
unit
Brightness 3
Measure interface display mode
1
LCD Brightness time
0(mean display at all times )
Demo mode
off
Themes 3
Alarm sound indication
on
Alarm pause time
10
second
SpO2 alarm high limit
100
%
SpO2 alarm low limit
85
%
Pulse rate alarm high limit
120
bpm
Pulse rate alarm low limit
50
bpm
Vo lu m e 3
22
Appendix I
Guidance a nd manufacturer’s declar ation – electromagnetic emission
The CMS70A is intended for use in the electromagnetic environment specified below. The
customer of the user of the CMS70A should assure that it is used in such and environment.
Emission test
Compliance
Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1
The CMS70A uses RF energy only for its internal
function. Therefore, its RF e missions are very low
and are not likely to cause any interference in
nearby electronic equipment.
RF emission
CISPR 11
Class B
The CMS70A 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.
Harmonic emissions
IEC 61000-3-2
Class A
Vo lt a g e f l u c tuations/
flicker emissions
IEC 61000-3-3
Complies
Guidance a nd manufacturer’s declaration – electromagnetic emissions-
for all EQUIPMENT and SYSTEMS
23
Guidance a nd manufacturer’s declar ation – electromagnetic immunity
The CMS70A is intended for use in the electromagnetic environment specified below. The
customer or the user of CMS70A should assure that it is used in such an environ ment.
Immunity
test
IEC 60601 test
level
Compliance
level
Electromagnetic environment -
guidance
Electrostatic
discharge
(ESD)
IEC
61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, c oncrete
or ceramic ti le. If floor are
covered with synthetic material,
the relative humidity should be at
least 30%.
Electrical fast
transient/burst
IEC
61000-4-4
±2 kV for power
supply lines
±2kV for
power supply
lines
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC
61000-4-5
±1 kV
differential mode
±2 kV common
mode
±1 kV
differential
mode
±2 kV common
mode
Mains power quality should be
that of a typical commercial or
hospital environment.
Vo lt a g e d i p s ,
short
interruptions
and voltage
variations on
power supply
input lines
IEC
61000-4-11
<5% UT
(>95% dip in
UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
<5% UT
(>95% dip in
UT)
for 0.5 cycle
40% UT
(60% dip in
UT)
for 5 cycles
Mains power quality should be
that of a typical commercial or
hospital environment.
Guidance a nd manufacturer’s declaration – electromagnetic immunity –
for all EQUIPMENT and SYSTEMS
24
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in
UT)
for 5 sec
70% UT
(30% dip in
UT)
for 25 cycles
<5% UT
(>95% dip in
UT)
for 5 sec
Power
frequency
(50/60Hz)
magnetic field
IEC
61000-4-8
3A/m
3A/m
Mains power quality should be
that of a typical commercial or
hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
25
Guidance a nd manufacture’s declaration – electromagnetic immunity
The CMS70A is intended for use in the electromagnetic environment specified below. The
customer or the user of CMS70A should assure that it is used in such an environ ment.
Immunity
test
IEC 60601
test level
Complia
nce level
Electromagnetic environment - guidance
Conducted
RF
IEC
61000-4-6
Radiated
RF
IEC
61000-4-3
3Vrms
150 kHz to 80
MHz
outside ISM
bands
3 V/m
80 MHz to 2.5
GHz
3 V
rms
(for main
power
line)
1V
rms
(for
probe)
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any part
of the CMS70A, 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 2.5 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 f ollowing symbol:
P
V
d
ú
û
ù
ê
ë
é
=
1
5.3
P
E
d
ú
û
ù
ê
ë
é
=
1
5.3
P
E
d
ú
û
ù
ê
ë
é
=
1
7
Guidance a nd manufacture’s declaration – electromagnetic immunity –
for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
26
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 ra dios, 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
CMS70A is used exceeds the applicable RF compliance level above, the CMS70A
should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or rel ocating the CMS70A.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3
V/m .
27
Recommended separation distances between
portable and mobile RF communications equipment and the CMS70A
The CMS70A is intended for use in an electromagnetic environment in
which radiated RF disturbances are controlled. The customer or the user of
the CMS70A can help prevent electromagnetic interference by maintaining a
minimum d istance between portable an d mobile RF communications
equipment (transmitters) and the CMS70A 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 2.5 GHz
Main power
line
probe
0.01
0.12
0.35
0.12
0.23
0.1
0.37
1.11
0.37
0.74
1
1.2
3.50
1.17
2.33
10
3.7
11.07
3.69
7.38
100
12
35.00
11.67
23.33
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 applica ble 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
ú
û
ù
ê
ë
é
=
1
5.3
P
E
d
ú
û
ù
ê
ë
é
=
1
5.3
P
E
d
ú
û
ù
ê
ë
é
=
1
7
Recommended separation distances between portable and mobile
RF communications equipment and the EQUIPMENT or SYSTEM –
for EQUIPMENT or SYSTEM that are not LIFE-SUPPORTING
28
Recommended separation distances between
portable and mobile RF communications equipment and the CMS70A
The CMS70A is intended for use in an electr omagnetic environment in
which radiated RF disturbances are controlled. The customer or the user of
the CMS70A can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communication s
equipment (transmitters) and the CMS70A 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 2.5 GHz
Main
power line
probe
0.01
0.12
0.35
0.12
0.23
0.1
0.37
1.11
0.37
0.74
1
1.2
3.50
1.17
2.33
10
3.7
11.07
3.69
7.38
100
12
35.00
11.67
23.33
For transmitters rated at a ma ximum output p ower not listed above, t he 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
ú
û
ù
ê
ë
é
=
1
5.3
P
E
d
ú
û
ù
ê
ë
é
=
1
5.3
P
E
d
ú
û
ù
ê
ë
é
=
1
7
Recommended separation distances between portable and mobile
RF communications equipment a nd the EQUIPMENT or SYSTEM –
for EQUIPMENT or SYSTEM that are not LIFE-SUPPORTING
Disposal: The product must not be disposed of along with other domestic waste.
The users must dispose of this equipment by bringing it to a specic recycling
point for electric and electronic equipment.
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.
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