Page 1
PROFESSIONAL MEDICAL PRODUCTS
PULSOXIMETRO OXY-200
OXY-200 PULSE OXIMETER
OXYMÈTRE DE POULS OXY-200
PULSIOXÍMETRO OXY-200
CMS70A (GIMA 35213)
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
Importato da / Imported by / Importé par / Importado por:
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
M35213-M-Rev.0-02.22
IP21
0123
Page 2
ENGLISH
26
Instructions to User
Dear users, thank you very much for purchasing the Pulse Oximeter (hereinafter referred to as 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 modications and software upgrades, the information
contained in this document is subject to change without notice.
It is a medical device, which can be used repeatedly.
The Manual describes, in accordance with the device’s features and requirements, main structure, functions, specications, correct methods for transportation, installation, usage, operation, repair, maintenance and storage, etc. as well as the safety procedures to protect both the user and device. Refer to
the respective chapters for details.
Please read the User Manual carefully before using this device. The User Manual which describes the
operating procedures should be followed strictly. Failure to follow the User Manual may cause measuring abnormality, device damage and human injury. The manufacturer is NOT responsible for the safety,
reliability and performance issues and any monitoring abnormality, human injury and device damage
due to users’ negligence of the operation instructions. The manufacturer’s warranty service does not
cover such faults.
Owing to the forthcoming renovation, the specic products you received may not be totally in accordance with the description of this User Manual. We would sincerely regret for that.
Our company has the nal interpretation to this manual. The content of this manual is subject to change
without prior notice.
Warnings
Remind that it may cause serious consequences to tester, patient or environment.
Explosive hazard—DO NOT use the device in environment with inammable gas such as anesthetic.
DO NOT use the device while examining by MRI or CT, as the induced current may cause burn.
Do not take the information displayed on the device as the sole basis for clinical diagnosis. The de-
vice is only used as an auxiliary means in diagnosis. And it must be used in conjunction with doctor’s
advice, clinical manifestations and symptoms.
The maintenance to the device or replacement of the battery (non-detachable lithium battery) can
only be performed by qualied service personnel specied by manufacturer, dangers (such as
over-temperature, re or explosion) may occur when replacing the battery by the personnel not fully
trained. Patients are not permitted to maintain or ret the device by themselves.
Please do not open the device enclosure to avoid possible electric shock.
Uncomfortable or painful feeling may appear if using the device ceaselessly, especially for the micro-
circulation disturbance patients. It is not recommended that the sensor is used on the same nger for
more than 2 hours.
For some special patients who need a more careful inspection on the test site, please don’t place the
device on the edema or tender tissue.
Please do not stare at the red and infrared light emitter (the infrared light is invisible) after turning on
the device, including the maintenance staff, as it may be harmful to the eyes.
The device contains silicone, PVC, TPU, TPE and ABS materials, whose biocompatibility has been
tested in accordance with the requirements in ISO 10993-1, and it has passed the recommended
biocompatibility test. The person who is allergic to silicone, PVC, TPU, TPE or ABS can not use this
device.
The disposal of scrap device, its accessories and packaging should follow the local laws and regula-
tions, to avoid polluting to the local environment. And the packaging materials must be placed in the
region where the children are out of reaching.
The device can not be used with the equipment not specied in the Manual. Only the accessories
appointed or recommended by the manufacturer can be used, otherwise it may cause injury to the
tester and operator or damage to the device.
The SpO2 probe accompanied is only suitable for using with the device. The device can only use the
SpO2 probe described in the Manual, so the operator has the responsibility to check the compatibility
between the device and the SpO2 probe before using, incompatible accessories may cause device
performance degradation, device damage or patient injury.
Do not reprocess the accompanying SpO2 probe.
Check the device before use to make sure that there is no visible damage that may affect patient’s
safety and device performance. When there is obvious damage, please replace the damaged parts
before use.
Page 3
27
ENGLISH
When the message “Sensor Off” or “Sensor Fault” appears on the screen, it indicates that the SpO2
probe is disconnected or line fault occurs. Check the connection of the SpO2 probe and whether
there is damage for the probe, if necessary, please replace the probe to avoid risks. The probe fault
will not result in a safety hazard.
Functional testers can not be used to assess the accuracy of the SpO2 probe and Pulse Oximeter.
Some functional testers or patient simulators can be used to verify whether the device works normal-
ly, for example, INDEX-2LFE Simulator (software version: 3.00), please refer to the Manual for the
detailed operation steps.
Some functional testers or patient simulators can measure the accuracy of the device copied calibra-
tion curve, but they can not be used to evaluate the device accuracy.
When using the device, please keep it away from the equipment which can generate strong electric
eld or strong magnetic eld. Using the device in an inappropriate environment may cause interference to the surrounding radio equipment or affect its working.
When storing the device, keep it away from children, pets and insects to avoid affecting its perfor-
mance.
Do not place the device in places exposed to direct sunlight, high temperature, humidity, dust, cotton
wool or easy to splash water, to avoid affecting its performance.
The measured accuracy will be affected by the interference of electrosurgical equipment.
Do not rely on the alarm system of the device solely, the alarm function must be veried regularly.
The most reliable method of use is to closely monitor and correctly use it .
When several products are used on the same patient simultaneously, danger may occur which is
arisen from the overlap of leakage current.
CO poisoning will appear excessive estimation, so it is not recommended to use the device.
This device is not intended for treatment.
The intended operator of the device may be a patient
Avoid maintaining the device during using.
Users should read the product manual carefully before use and operate according to the require-
ments.
Page 4
ENGLISH
CONTENTS
1 Overview ........................................................................................................................................ 28
1.1 Features .................................................................................................................................... 28
1.2 Indication for Use ...................................................................................................................... 29
1.3 Environment Requirements.......................................................................................................29
1.4 Precautions ............................................................................................................................... 29
2 Principle ......................................................................................................................................... 31
3 Functions ....................................................................................................................................... 31
4 Installation .................................................................................................................................... 32
4.1 Appearance ...............................................................................................................................32
4.2 Interface introduction.................................................................................................................33
4.3 SpO2 probe installation ............................................................................................................. 33
4.4 Connection of data line .............................................................................................................33
4.5 Structure, accessories and software description.......................................................................33
5 Operating ..................................................................................................................................... 33
5.1 Measurement ............................................................................................................................ 33
5.2 Measurement interface .............................................................................................................34
5.3 Menu operation ......................................................................................................................... 34
5.4 Data upload ............................................................................................................................... 40
5.5. Charging...................................................................................................................................41
5.6 Reset ......................................................................................................................................... 41
6 Maintain, Transport and Storage .................................................................................................41
6.1 Cleaning and disinfection .......................................................................................................... 41
6.2 Maintenance..............................................................................................................................41
6.3 Transport and Storage ..............................................................................................................41
7 Troubleshooting ............................................................................................................................42
8 Key of Symbols ............................................................................................................................. 42
9 Specication .................................................................................................................................. 43
10 Factory Default ............................................................................................................................. 44
Appendix ............................................................................................................................................ 45
EMC ....................................................................................................................................................45
28
1 OVERVIEW
The oxygen saturation is the percentage of HbO2 in the total Hb in the blood, so-called the O2 concentration in the blood, it is an important physiological parameter for the respiratory and circulatory system.
A number of diseases related 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 difculty 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 eld.
Insert the nger when measuring, the device will directly display the SpO2 value measured, it has a
higher accuracy and repeatability.
1.1 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).
Page 5
29
ENGLISH
1.2 Indication for Use
The Pulse Oximeter can be used in measuring the pulse oxygen saturation and pulse rate through
nger. 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.
1.3 Environment Requirements
Storage Transportation Environment
a) Temperature : -40℃ ~ 60℃
b) Relative humidity : ≤95%
c) Atmospheric pressure :500 hPa~1060 hPa
Operating Environment
a) Temperature:10℃ ~ 40℃
b) Relative Humidity : ≤75%
c) Atmospheric pressure:700 hPa~1060 hPa
1.4 Precautions
1.4.1 Attention
Point out conditions or practices that may cause damage to the device or other properties.
Before using the device, make sure that it locates in normal working state and operating environ-
ment.
In order to get a more accurate measurement, it should be used in a quiet and comfortable environ-
ment.
When the device is carried from cold or hot environment to warm or humid environment, please do
not use it immediately, wait four hours at least is recommended.
If the device is splashed or coagulated by water, please stop operating.
DO NOT operate the device with sharp things.
High temperature, high pressure, gas sterilizing or immersion disinfection for the device is not per-
mitted. Refer to User Manual in the relative chapter (6.1) for cleaning and disinfection. Please turn
off the device and disconnect it from the power.
The device is suitable for children and adult.
The device may not be suitable for all patients, if you can’t get a satisfactory result, please stop using
it.
Data averaging and signal processing generate delay on displayed and transmitted SpO2 value and
alarm signal generation. The data update period is shorter than 30 s, the time for obtaining dynamic
average values will increase, which is arisen from signal degradation, low perfusion or other interference, it depends on the PR value.
The device has 3-year service life, date of manufacture: see the label.
To further detect the alarm of individual measurement parameter, measure and check oneself or with
a simulator, adjust the alarm limit setting and check whether the correct alarm can be triggered.
This device has the function of alarm, patients can check on this function according to chapter 5.3 as
a reference.
The device has the function of limits alarm, when the measured data is beyond the highest or lowest
limit, the device would start alarm automatically on the premise of the alarm function is on.
The device has the function of alarm, this function can either be paused, or closed for good. This
function could be turned on through menu operation if you need. Please check the chapter 5.3 as a
reference.
The maximum temperature at the SpO2 probe -tissue interface should be less than 41℃ which is
measured by the temperature tester.
During measuring, when abnormal conditions appear on the screen, please pull out your nger and
reinsert it to measure again.
If some unknown error appears during measuring, press “RESET” button to reset it.
Do not contort or drag the wire of the device.
The plethysmographic waveform is not normalized, as a signal inadequacy indicator, when it is not
smooth and stable, the accuracy of the measured value may degrade. When it tends to be smooth
and stable, the measured value read is the optimal and the waveform at this time is also the most
standard.
Page 6
ENGLISH
30
If necessary, please visit our ofcial website to get the information about SpO2 probe that can be
used with this device.
If the device or component is intended for single-use, then the repeated use of these parts will pose
risks on the parameters and technical parameters of the equipment known to the manufacturer.
If necessary, our company can provide some information (such as circuit diagrams, component lists,
illustrations, etc.), so that the qualied technical personnel of the user can repair the device components designated by our company.
The measured results will be inuenced by the external colouring agent (such as nail polish, colour-
ing agent or color skin care products, etc.), so don’t use them on the test site.
As to the ngers which are too cold or too thin or whose ngernail is too long, it may affect the meas-
ured results, so please insert the thicker nger such as thumb or middle nger deeply enough into
the probe when measuring.
The nger should be placed correctly(see Attached gure 4), as improper installation or improper
contact position for sensor will inuence the measurement.
The light between the photoelectric receiving tube and the light-emitting tube of the device must
pass through the subject’s arteriole. Make sure the optical path is free from any optical obstacles like
rubberized fabric, to avoid inaccurate results.
Excessive ambient light may affect the measured results, such as surgical light (especially xenon
light sources), bilirubin lamp, uorescent lamp, infrared heater and direct sunlight, etc. In order to
prevent interference from ambient light, make sure to place the sensor properly and cover the sensor
with opaque material.
Frequent movement (active or passive) of the subject or severe activity can affect the measured
accuracy.
The SpO2 probe should not be placed on a limb with the blood pressure cuff, arterial ductus or intra-
luminal tube.
The measured value may be inaccurate during debrillation and in a short period after debrillation,
as it has not debrillation function.
The device has been calibrated before leaving factory.
The device is calibrated to display functional oxygen saturation.
The equipment connected with the Oximeter interface should comply with the requirements of IEC
60601-1.
The computer intended to be connected with this device,shall be approved and certicated according
to IEC 60950.
After the mains is interrupted, the device will automatically switch to battery for working, it will auto-
matically switch to mains after it is restored.
1.4.2 Clinical restriction
A. As the measure is taken on the basis of arteriole pulse, substantial pulsating blood ow 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
measurement will be more sensitive to interference.
B. The measurement will be inuenced by intravascular staining agents (such as indocyanine green or
methylene blue), skin pigmentation.
C. The measured value may be normal seemingly for the tester who has anemia or dysfunctional he-
moglobin(such as carboxyhaemoglobin (COHb), methaemoglobin (MetHb) and sulfhaemoglobin
(SuHb)), but the tester may appear hypoxia, it is recommended to perform further assessment according the clinical situations and symptoms.
D. Pulse oxygen only has a reference meaning for anemia and toxic hypoxia, as some severe anemia
patients still show better pulse oxygen measured valued.
E. Contraindication:
a. The person who is allergic to silicone, PVC, TPU TPE or ABS can not use this device.
b. The damaged skin tissue can’t be measured.
c. During cardiopulmonary resuscitation.
d. When the patient is too hypovolemic.
e. For assessing the adequacy of ventilatory support.
f. For detecting worsening lung function in patients on a high concentration of oxygen.
Page 7
31
ENGLISH
2 PRINCIPLE
Glow and Infrared ray
Emission Tube
Glow and Infrared ray
Receipt Tube
Figure 1. Operating 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 nger-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.
3 FUNCTIONS
A. SpO2 value display
B. Pulse rate value display, bar graph display
C. PI value display
D. Pulse waveform display
E. Battery power display
F. Low-power indication: low-power indication symbol appears before working abnormity which is due
to low-power.
G. Review function
H. Screen brightness can be adjusted
I. Volume can be adjusted
J. Display mode can be adjusted
K. Pulse sound indication
L. With alarm function, the patient could set alarm limit.
M. With real-time data uploading function.
N. With clock function
O. With two kinds of power supply mode(alternating current and internal electrical power source)
Page 8
4 INSTALLATION
4.1 Appearance
ENGLISH
32
Figure 2. Appearance
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.
Alarm lamp: When data’s going beyond the limits, low-voltage, nger out, sensor off or sensor fault, the
alarm light will be on.
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/conrm button: when alarm happens, short press it to make alarm sound pause. The
pause time could be set by menu. Long press it to conrm the alarm, and there will be no alarm this
time.
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.
USB port: It is used to connect computer to transmit data by data line.
Power supply jack: power supply line interface.
Note: During data transmitting, please do not use this device.
Page 9
33
ENGLISH
4.2 Interface introduction
Figure 3. Measurement interface
4.3 SpO2 probe installation
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 manufacturers).
4.4 Connection of data line
Please connect the data line to device, the other end into computer.
4.5 Structure, accessories and software description
A. Structure: main unit, Oximeter probe, A power supply line and A data line.
B. Accessories: one User Manual, one power supply line, one data line, one Oximeter probe.
Optional: A Other Oximeter probe
C. Software description
Release version: 2.0
5 OPERATING
5.1 Measurement
Put the nger into the probe as Figure 4.
Figure 4. Sketch map for nger placement
(The appearance of actual probe may be different with the one shown as Figure 4, please refer to the
actual probe.)
Page 10
ENGLISH
A. Short press power button to turn on the device. If use alternating current, make sure that the power
supply line is connected accurately.
B. Do not shake the nger 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.
Note: Fingernails and the luminescent tube should be at the same side.
Note: If the alarm function is on, the device will provide alarm signal when probe or nger is out.
34
5.2 Measurement interface
A. Alarm including the alarm of measure data’s going beyond the limits, the alarm of low-voltage, the
alarm of nger out, the alarm of sensor off, the alarm of sensor fault.
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. Long press it to conrm the alarm, and
there will be no alarm this time.
5.3 Menu operation
Under the measurement interface, press the menu button to enter the main menu interface as shown in
Figure 5, system, display, clock, alarm and recond , etc. can be set, methods are as followings:
Figure 5. Main menu
5.3.1 System setting
In the main menu interface, choose “System” item, then press menu button to enter the System setting
menu as gure 6:
Figure 6. System setting menu
A. Prompt volume: move the choice bar to the “Volume” item, then press left/right button to set the vol-
ume (three levels).
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. Version: move the choice bar to the “Version” item, then press the menu button to see the edition in-
formation 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 <Smart Device Assistant> for detail.
Page 11
35
ENGLISH
F. Factory Default: move the choice bar to the “Factory Default” item, enter the password in the pop-
up interface(Please refer to chapter 5.3.4), 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 afrm setting, then press return button to return the system setting menu interface.
5.3.2 Display setting
In the main menu interface, choose “Display” item, then press menu button to enter the display 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 gure 8 and gure 9.
Note: in measure interface,the patient could press mode switch button to switch display mode
too.
Figure 8. Interface 1 Figure 9. Interface 2
C. LCD ON (min): move the choice bar to the “LCD ON” item, then press left/right button to set display
time (range:1~60min). INF 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 func-
tion.
E. Theme: move the choice bar to “Theme” item, then press left/right button to set theme (Three kinds
of theme are optional).
Page 12
ENGLISH
36
5.3.3 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:
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.
5.3.4 Alarm setting
When the device is turned on, the red and yellow alarm lamp ash alternately once, which indicates that
the alarm system is working.
In the main menu interface, move the choice bar to “Alarm” item, then press menu button to enter the
password interface of Figure 11.
Figure 11. password interface
After inputting password (The factory default is7762), move the choice bar to , then press menu
button to enter the alarm menu of Figure 12.
Figure 12. Alarm menu
Page 13
37
ENGLISH
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 afrming.
Note: If the alarm function is on, the device will provide alarm sound when the measure value is
beyond the limit.
B. move the choice bar to “Set Alarm” item, then press menu button to enter the set alarm menu of
Figure 13.
Figure 13. set alarm menu
a. SpO2 Alarm: move the choice bar to the “SpO2 Alarm” item, then press left/ right button to set SpO2
Alarm.
b. PR Alarm: move the choice bar to the “PR Alarm” item, then press left/ right button to set PR Alarm.
c. Alarm Volume: move the choice bar to the “Alarm Volume” item, then press left/ right button to set
the volume (three levels).
d. Alarm Pause(sec): move the choice bar to the “Alarm Pause(sec)” item, then press left/right to set
the alarm pause time. (60/120/600/INF, INF mean display at all times).
e. Set Password: move the choice bar to the “Set Password” item, then press menu button to enter the
Password interface of Figure 14 to set a new password.
Figure 14. New Password
interface
Note: Password can be 1~4 digits. The new password cannot be the same as the old password.
f. Alarm Password: move the choice bar to the “Alarm Password” item, then press left/right button to
set Alarm Password.
Note: When on, you need a password to enter the alarm menu, but you don’t need a password
to enter the set alarm menu. When off, you don’t need a password to enter the alarm menu, but
you need a password to enter the set alarm menu.
Page 14
ENGLISH
38
5.3.5 Record setting
In the main menu interface, move the choice bar to “Record” item, then press menu button to enter
record menu as Figure 15.
Figure 15. 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 16.
When recording, choose “off”, and press menu button to stop recording.
Figure 16. 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 can input 4 letters most. 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 gure 17 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.
Figure 17. Replace the existed
ID dialog box
Page 15
39
ENGLISH
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 Mem-
ory” dialog box. After deleting ID, the record can be continued.
Note: If the device is restarted in the process of recording, the device will lose the segment of
recording data.
Note: 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 gure 18.
Figure18. 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 gure 19. Choose “Yes” and press menu button to delete ID. Choose “No”
to return to the memory manager interface.
Figure 19. 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 gure 20.
Page 16
ENGLISH
Figure 20. 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 gure 21. Choose “TREND” to enter trend review interface as gure
22.
40
Figure 21. VALUE review interface Figure 22. 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.
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.
5.3.6 Close the device
A. In the main menu interface, move the choice bar to the “Power “ item, then press menu button to
close 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.
5.4 Data upload
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 <Smart Device Assistant> for detail.
Note: If the patients 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 again.)
Page 17
41
ENGLISH
5.5. Charging
Connect the device to power supply with power line.
Note: 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 nished. When the device is open 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 nished.
5.6 Reset
Long press the power key to reset.
6 MAINTAIN, TRANSPORT AND STORAGE
6.1 Cleaning and disinfection
Please turn off the device and disconnect it from the power,do not immerse it into liquid.
Use 75% alcohol to wipe the device enclosure, and use liquid soap or isopropanol to wipe the watchband for disinfection, nature dry or clean it with clean and soft cloth. Do not spray any liquid on the
device directly, and avoid liquid penetrating into the device.
6.2 Maintenance
A. Check the main unit and all accessories periodically to make sure that there is no visible damage that
may affect peopls safety and monitoring performance. It is recommended that the device should be
inspected weekly at least. When there is obvious damage, stop using it.
B. Please clean and disinfect the device before/after using it according to the User Manual (6.1).
C. 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. The device need not to be calibrated during maintenance.
E. Please recharge the battery when the screen shows low power alarm information.
F. Patients are advised to calibrate the device termly (or according to the calibrating program of hospi-
tal). It also can be performed at the state-appointed agent or just contact us for calibration.
G. Check the backup power of the device regularly, when it can not support 1-hour continuous opera-
tion, please contact after-sales to replace the battery.
6.3 Transport and Storage
A. The packed device can be transported by ordinary conveyance or according to transport contract.
During transportation, avoid strong shock, vibration and splashing with rain or snow, and it can not
be transported mixed with toxic, harmful, corrosive material.
B. The packed device should be stored in room with no corrosive gases and good ventilation. Temper-
ature: -40°C ~ +60°C; Relative humidity: ≤95%.
Page 18
ENGLISH
7 TROUBLESHOOTING
Trouble Possible Reason Solution
The values can not be
displayed normally or stably.
The device can not be turned on1) 1. Low battery or the battery is drained
The display disappears
suddenly.
The device can not be used
for full time after charge
The battery can not be full
charged even after 10 hours
charging time.
The data can not be stored. 1) The device is not operated according to
1) 1.The nger is not properly inserted.
2) The nger is shaking or the patient is
moving.
3) The device is not used in environment
required by the manual.
4) The device works abnormally.
away.
2) The device works abnormally.
1) 1. Low battery.
2) The device works abnormally.
1) 1. The battery is not charged fully.
2) The device works abnormally.
The device works abnormally Please contact the after-sales
the manual.
2) The device works abnormally.
1) Please insert the nger properly
and measure again.
2) Let the patient keep calm.
3) Please use the device in normal
environment.
4) Please contact the after-sales.
1) Please charge the battery.
2) Please contact the after-sales
1) 1. Please charge the battery.
2) Please contact the after-sales
1) Please charge the battery.
2) Please contact the after-sales
1) Please operate the device accord-
ing to the manual.
2) Please contact the after-sales
8 KEY OF SYMBOLS
Symbols Meaning Symbols Meaning
Follow instructions for use Pulse rate (bpm)
42
Perfusion Index (%) Pulse oxygen saturation (%)
The battery power is full Two grid of the battery
One grid of the battery Low battery
Pulse oxygen saturation Alarm Pulse rate Alarm
Pulse sound indication:
cyan- on; white-off
PR indication: when there is pulse
jumpiness, it glitters and op
Kinescope indication: when
Kinescope-red; else circs-white
Finger out (no nger)
Alarm off Alarm pause
Alarm on
Power on/off button
USB
Finger Out
SENSOR
FAULT
Type BF applied part
Probe error
Signal indication is not enough.
Sensor fault(probe fault)
Serial number Class II applied
Page 19
43
ENGLISH
SENSOR OFF
The sensor is off (probe-off) Manufacturer
Alternating current indicator light Temperature limit
IP21 Covering Protection rate Atmospheric pressure limit
Date of manufacture Fragile, handle with care
Humidity limit Recovery
This side up
Keep in a cool, dry place
Lot number
Authorized representative in the
European community
P/N Material code WEEE disposal
Medical Device complies
with Directive 93/42/EEC
Product code
Note: Your device may not contain all the following symbols.
9 SPECIFICATION
SpO2 [see note 1]
Display range 0% ~ 100%
Measured range 0% ~ 100%
Accuracy [see note 2] 70% ~ 100%: ±2%;
Resolution 1%
PR
Display range 30 bpm ~ 250 bpm
Measured range 30 bpm ~ 250 bpm
Accuracy [see note 3] ±2 bpm or ±2%, whichever is greater.
Resolution 1 bpm
PI
Display range 0% ~ 20%
Measured range 0% ~ 20%
Accuracy 1% ~ 20%: ±1%
Resolution 0,1%
Accuracy under low perfusion
[see note 4]
Light interference Under normal and ambient light conditions, the SpO2 deviation ≤ 1%
Pulse intensity Continuous bar graph display, the higher display indicates the strong-
Upper and lower limit of alarm values
SpO2 0% ~ 100%
PR 0 bpm ~ 254 bpm
0% ~ 69%: unspecied.
0% ~ 0,9%: ±0,2%
Low perfusion 0.4%:
SpO2: ±4%;
PR: ±2 bpm or ±2%, whichever is greater
er pulse.
Page 20
ENGLISH
44
Optical sensor [see note 5]
Red light Wavelength: about 660 nm, optical output power: < 6.65 mW
Infrared light Wavelength: about 905 nm, optical output power: < 6.75 mW
Memory Every patient ID could save 24-hour data, the device could save 16
patient ID.
Safety class II genus, Interior Battery, BF Type
International Protection IP21
Alternating current supply 100 ~ 240V CA, 50/60 Hz
Internal electrical power source 3,6V CC ~ 4,2V CC
Power supply A rechargeable lithium battery (3.7 V) (The red wire on the battery
denotes anode, the black wire on the battery denotes cathode.)
Battery life Charge and discharge: no less than 500 times.
Dimension and Weight
Dimension 269(L) × 222(W) × 79(H) mm
Weight About 1 kg (with a lithium battery)
Note 1: the claims of SpO2 accuracy shall be supported by clinical study measurements taken over the full range. By articial inducing, get
the stable oxygen level to the range of 70 % to 100 % SpO2, compare the SpO2 values collected by the secondary standard pulse oximeter
equipment and the tested equipment at the same time, to form paired data, which are used for the accuracy analysis.(It is applicable for the
probes equipped.)
There are 12 healthy volunteers (male: 6. female: 6; age: 18~50; skin color: black: 2, light: 8, white: 2) data in the clinical report.
Note 2: because pulse oximeter equipment measurements are statistically distributed, only about two-thirds of pulse oximeter equipment
measurements can be expected to fall within ±Arms of the value measured by a CO-OXIMETER.
Note 3: Patient simulator has been used to verify the pulse rate accuracy, it is stated as the root-mean-square difference between the PR
measurement value and the value set by simulator.
Note 4: percentage modulation of infrared signal as the indication of pulsating signal strength, patient simulator has been used to verify its
accuracy under conditions of low perfusion. SpO2 and PR values are different due to low signal conditions, compare them with the known
SpO2 and PR values of input signal.
Note 5: optical sensors as the light-emitting components, will affect other medical devices applied the wavelength range. The information
may be useful for the clinicians who carry out the optical treatment. For example, photodynamic therapy operated by clinician.
10 FACTORY DEFAULT
default unit
Brightness 3
Measure interface display mode 1
LCD Brightness time INF (mean display at all times )
Demo mode off
Themes 3
SpO2 alarm sound indication on
Pulse rate alarm sound indication on
Alarm pause time 120 sec
SpO2 alarm high limit 100 %
SpO2 alarm low limit 85 %
Pulse rate alarm high limit 120 bpm
Pulse rate alarm low limit 30 bpm
Prompt volume 3
Password 7762
Alarm volume 3
Alarm password on
Pulse sound on
Key sound on
Page 21
45
ENGLISH
APPENDIX
Alarm state Alarm state delay Alarm signal generation delay
Low battery alarm 60 s 5 ms
Over-limit alarm for SpO2 1 s 5 ms
Over-limit alarm for pulse rate 1 s 5 ms
“Sensor Off” alarm 16 ms 5 ms
EMC
Table 1
Guidance and manufacturer’s declaration –electromagnetic emission
The Pulse Oximeter is intended for use in the electromagnetic environment specied below. The
purchaser or the user of the device should assure that it is used in such environment.
Emission test Compliance
RF emissions CISPR 11 Group 1
RF emissions CISPR 11 Class B
Harmonic emissions IEC 61000-3-2 Class A
Voltage uctuations/icker emissions IEC 61000-3-3 Complies
Table 2
Guidance and manufacturer’s declaration-electromagnetic immunity
The Pulse Oximeter is intended for use in the electromagnetic environment specied below. The purchaser or the user of the Pulse Oximeter should assure that it is used in such environment.
Immunity test IEC60601 test level Compliance level
Electrostatic discharge (ESD)
IEC 61000-4-2
Electrical fast transient/burst
IEC 61000-4-4
Surge IEC 61000-4-5 ±1 kV lines to lines
Voltage dips, short interruptions and
voltage variations on power supply
input lines IEC 61000-4-11
Power frequency (50 / 60Hz)
±8kV contact
±15 kV air
±2kV for power supply lines
±1 kV for input/output line
±8kV contact
±15 kV air
±2kV for power supply lines
Not Applicable
±1 kV lines to lines
±2 kV lines to earth
<5%UT(>95%dip in UT)
for 0.5 cycle
40% UT(60%dip in UT)
for 5 cycle
70%UT(30%dip in UT)
for 25 cycle
<5%UT(>95%dip in UT)
for 5 sec
Not Applicable
<5%UT(>95%dip in UT)
for 0.5 cycle
40% UT(60%dip in UT)
for 5 cycle
70%UT(30%dip in UT)
for 25 cycle
<5%UT(>95%dip in UT)
for 5 sec
30 A/m 30 A/m
magnetic eld IEC 61000-4-8
Page 22
ENGLISH
Table 3
Guidance and manufacturer’s declaration – electromagnetic immunity
The Pulse Oximeter is intended for use in the electromagnetic environment specied below. The customer the user of the Pulse Oximeter should assure that it is used in such environment.
Immunity test IEC 60601 test level Compliance level
Conducted RF
IEC61000-4-6
Conducted RF
IEC61000-4-6
Radiated RF
3 V
0,15 MHz – 80 MHz
6 V in ISM bands between
0,15 MHz and 80 MHz
3 V
0,15 MHz – 80 MHz
6 V in ISM bands between
0,15 MHz and 80 MHz
3 V
0,15 MHz – 80 MHz
6 V in ISM bands between
0,15 MHz and 80 MHz
3 V
0,15 MHz – 80 MHz
6 V in ISM bands between
0,15 MHz and 80 MHz
10 V/m 80 MHz - 2,7 GHz 10 V/m80 MHz - 2,7 GHz
IEC61000-4-3
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 reection from structures, objects and people.
a Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to xed RF transmitters, an electromagnetic site survey
should be considered. If the measured eld strength in the location in which the Pulse Oximeter is used exceeds
the applicable RF compliance level above, the Pulse Oximeter should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the
Pulse Oximeter.
46
Page 23
47
ENGLISH
Table 4
Guidance and manufacturer’s declaration - electromagnetic Immunity
The [Code SI] is intended for use in the electromagnetic environment specied below.
The customer or the user of the Pulse Oximeter should assure that it is used in such an environment
Test
Frequency
(MHz)
385 380 -390 TETRA 400 Pulse
450 380 -390 GMRS 460,
710 704 – 787 LTE
745
Radiated RF
IEC61000-
4-3
(Test speci-
cations for
ENCLOSURE
PORT IMMUNITY to
RF wireless
communications
equipment)
NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the
ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.
a) ) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50 % duty cycle square wave signal.
c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case.
The MANUFACTURER should consider reducing the minimum separation distance, based on RISK MANAGEMENT,
and using higher IMMUNITY TEST LEVELS that are appropriate for the reduced minimum separation distance.
Minimum separation distances for higher IMMUNITY TEST LEVELS shall be calculated using the following equation:
6
E=
d
Where P is the maximum power in W, d is the minimum separation distance in m, and E is the IMMUNITY TEST
LEVEL in V/m.
780
810 800 – 960 GSM
870
930
1720 1700 –
1845
1970
2450 2400 –
5240 5 100 –
5500
5785
√P
Band a)
(MHz)
1990
2570
5 800
Service a) Modulation b)Modulation
modulation
b) 18 Hz
FRS 460
Band 13,
17
800/900,
TETRA
800,
iDEN 820,
CDMA 850,
LTE Band 5
GSM 1800;
CDMA
1900;
GSM 1900;
DECT;
LTE Band
1, 3, 4, 25;
UMTS
Bluetooth,
WLAN,
802.11
b/g/n,
RFID 2450,
LTE Band 7
WLAN
802,11
a/n
FM c)
± 5 kHz
deviation
1 kHz sine
Pulse
modulation
b) 217 Hz
Pulse
modulation
b)
18 Hz
Pulse
modulation
b)
217 Hz
Pulse
modulation
b)
217 Hz
Pulse
modulation
b)
217 Hz
b) (W)
1,8 0,3 27
2 0,3 28
0,2 0,3 9
2 0,3 28
2 0,3 28
2 0,3 28
0,2 0,3 9
Distance
(m)
IMMUNITY
TEST LEVEL
(V/m)
Page 24
ENGLISH
48
Warning
1) Don’t near active HF SURGICAL EQUIPMENT and the RF shielded room of an ME SYSTEM for
magnetic resonance imaging, where the intensity of EM DISTURBANCES is high.
2) Use of this equipment adjacent to or stacked with other equipment should be avoided because it
could result in improper operation. If such use is necessary, this equipment and the other equipment
should be observed to verify that they are operating normally.
3) Use of accessories, transducers and cables other than those specied or provided by the manufac-
turer of this equipment could result in increased electromagnetic emissions or decreased electromag-
netic immunity of this equipment and result in improper operation.
4) Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches) to any part of the device including cables
specied by the manufacturer. Otherwise, degradation of the performance of this equipment could
result.
5) Active medical devices are subject to special EMC precautions and they must be installed and used
in accordance with these guidelines.
Note:
• When the device is disturbed, the data measured may uctuate, please measure repeatedly or in
another environment to ensure its accuracy.
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.
CONDIZIONI DI GARANZIA GIMA
Si applica la garanzia B2B standard Gima di 12 mesi.
Loading...