Contec CMS60D User manual

CMS60D User Manual
Pulse Oximeter
Contec Medical Systems Co., Ltd.
Address:No.112 Qinhuang West Street, Economic ＆Technical Development Zone,
Qinhuangdao, Hebei Province, PEOPLE’S REPUBLIC OF CHINA
Tel: [phone]
Fax: [phone]
Technical support: [phone]
E-mail: [email protected]
Website: http://www.contecmed.com
EC REPRESENTATIVE
Shanghai International Holding Corp. GmbH(Europe)
Address: Eiffestrasse 80, 20537, Hamburg, Germany
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
CMS2.782.089.01(BT.USB)(CE)ESS/1.0 1.4.01.01.852 2022.12
User Notice
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 modifications 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,
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 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 specific 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 final 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, user or environment.
 Explosive hazard—DO NOT use the device in environment with inflammable 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 device 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 can only be performed by qualified service personnel specified by
manufacturer, Users are not permitted to maintain or refit the device by themselves.
 Uncomfortable or painful feeling may appear if using the device ceaselessly, especially for the
microcirculation disturbance users. It is not recommended that the sensor is used on the same finger for more
than 2 hours.
 For some special users 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 regulations, 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 specified 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 user’s safety and
device performance. When there is obvious damage, please replace the damaged parts before use.
 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 normally, 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 calibration 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 field or
strong magnetic field. 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 performance.
 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.
 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 requirements.
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 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.
Insert the finger when measuring, the device will directly display the SpO2 value measured, it has a higher accuracy and
repeatability.
1.1 Features
A. Easy to use.
B. Small in volume, light in weight, convenient to carry.
C. Low power consumption.
1.2 Intended purpose
The Pulse Oximeter 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.
1.3 Environment requirements
Storage 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 environment.
 In order to get a more accurate measurement, it should be used in a quiet and comfortable environment.
 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 permitted. Refer to User
Manual in the relative chapter (6.1) for cleaning and disinfection. Please take out the internal battery before cleaning and
disinfection.
 The device is suitable for children and adult.
 The device may not be suitable for all users, if you can't get a satisfactory result, please stop using it.
 Data averaging and signal processing have a delay in the upgrade of SpO2 data values. When the data update period is less
than 30 seconds, 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.
 The expected service life of the attached parts or accessories of the equipment is two year.
 If the shelf life is less than the expected service life, the shelf life of the attached parts or accessories of the equipment is
two year.
 The device does not provide over-limit alarm function for SpO2 and PR, so it is inapplicable for using in the place where
need such function.
 This device has the function of prompting, users can check on this function according to chapter 5.5.1 as a reference.
 The device has the function of limits prompting, when the measured data is beyond the highest or lowest limit, the device
would start prompting automatically on the premise of the prompting function is on.
 The device has the function of prompting, 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 5.5.1 as a reference.
 The device hasn't low-voltage alarm function, it only shows the low-voltage, please change the battery when the battery
voltage is used up.
 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 finger and reinsert it to measure
again.
 If some unknown error appears during measuring, remove the battery to terminate operating.
 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.
 If necessary, please visit our official 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 qualified technical personnel of the user can repair the device components designated by our company.
 The measured results will be influenced by the external colouring agent (such as nail polish, colouring agent or color skin
care products, etc.), so don't use them on the test site.
 As to the fingers which are too cold or too thin or whose fingernail is too long, it may affect the measured results, so please
insert the thicker finger such as thumb or middle finger deeply enough into the probe when measuring.
 The finger should be placed correctly (see Attached figure 5), as improper installation or improper contact position for
sensor will influence 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, fluorescent 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 intraluminal tube.
 The measured value may be inaccurate during defibrillation and in a short period after defibrillation, as it has not
defibrillation 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.
1.4.2 Clinical restriction
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 measurement will be more sensitive to interference.
B. The measurement will be influenced 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 hemoglobin(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 hypovolemic.
e. For assessing the adequacy of ventilatory support.
f. For detecting worsening lung function in patients on a high concentration of oxygen.
1.5 Clinical indications
The Pulse Oximeter can be used in measuring the pulse oxygen saturation and pulse rate through finger.
2 Principle
Figure 1 Operating principle
An experience formula of data processing is established taking use of Lambert Beer Law according to Spectrum Absorption
Characteristics of Reductive Hemoglobin (Hb) and Oxyhemoglobin (HbO2) in red light & near-infrared light zones. On the basis
of the principle of Photoelectric Oxyhemoglobin Inspection Technology and Photoplethysmography technology, it uses two light
beams of different wavelengths to irradiate the human fingertip to obtain the measurement information from the photosensitive
element, after processed by the electronic circuits and microprocessor, displays the measured results on the screen.
3 Functions
A. SpO2 value display
B. PR value and bar graph display
C. Pulse waveform display
D. Low-voltage indication: Low-battery indication: low-battery indication appears when the battery voltage is too low to work
E. Screen brightness can be changed
F. Pulse sound indication
G. Voice prompt for over-limit, probe off /finger-out and low battery
H. With SpO2 value and pulse rate value record function, the stored data can be uploaded to computer
I. It can be connected with an external oximeter probe
J. Real-time data can be transmitted to computer
K. Review function
L. Clock function
4 Installation
4.1 Appearance
Figure 2. Front and top appearance
4.2 Battery installation
Figure 3. Batteries Installation
A. Refer to Figure 3. Use a screwdriver to unscrew the two screws from the battery compartment on the back of the product and
open the back cover of the battery compartment.
B. Insert the two AA size batteries properly in the right direction.
C. Close the battery back cover, screw on the screw.
Please take care when you insert the batteries, for the improper insertion may damage the device.
Please replace two new batteries of the same kind at the same time.
4.3 Probe installation
Inserting the SpO2 probe of the pulse oximeter in the probe jack, use a screwdriver to screw the screws (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 USB port
It is used to connect a personal computer to export the trend data (see Figure 4).
Figure 4. USB Port
4.5 Structure, accessories and software description
A. Structure: main unit, SpO2 probe, USB cable, Bluetooth adapter (optional).
B. Accessories: one adult-oximeter probe, two AA size batteries (optional), one USB cable, one CD disk
(including PC software, optional), one User Manual, Bluetooth adapter (optional).
Please check the device and accessories according to the list to avoid that the device can not work normally.
C. Software description
Software name: CMS60D embedded software
Software specification: no
Release version: 2.0
Naming rule for version: V <Major enhancive software upgrade>.<Minor enhancive software
upgrade>.<Improvement software upgrade>
Involved algorithm: name: plethysmography; type: mature arithmetic
Purpose: be used to measure SpO2, pulse rate, etc.
Clinical function: calculate SpO2 and pulse rate values by collecting and processing the testee’ s pulse signal.
5 Operating guide
5.1 Application method
A. Put the finger into the probe. Refer to Figure 5.
Figure 5 Sketch map for finger placement
(The appearance of actual probe may be different with the one shown as Figure 5, please refer to the actual probe.)
when inserting the finger, the light emitting from the sensor must be directly irradiated to the side of
the fingernail.
In the process of using the tested finger had better not shake, the human body also had better not be in
motion state.
B. Long press the "power on/off " button, until the device turns on.
C. Do not shake the finger and keep the user in a stable state during the process.
D. The data can be read directly from the screen in the measure interface.
5.2 Pause sound prompt
A. Sound prompt, including: over-limit, low-battery, finger out, sensor off and sensor fault.
B. Under the measurement interface, turn on the sound prompt, when the sound prompt occurs, short press the
button to pause the sound prompt, and it will resume automatically after about 60s.
C. If you want to turn off the sound prompt permanently, please set it in menu.
5.3 Review Interface
A. In the measure interface, press "up button" to enter the Review Interface 1 directly, as shown in Figure 6:
Figure 6-1. Review Interface 1 Figure 6-2. Review Interface 2
B. In review interface, press "menu button" to switch between Review Interface 1 and Review Interface 2.
C. In Review Interface 1,the user can observe the trend waveform composed by storage data. Each screen can
show storage data for 105 seconds.The yellow line shows the SpO2 trend waveform,and the red line shows the PR
trend waveform.The time underside shows the starting time of displaying the date in the screen, press the “left
button” or “right button” to view the information on the previous or next page of the stored data trend chart.
D. The Review Interface 2 shown based in Review Interface 1, the stored SpO2 value and PR value in each second
can be observed here, the underside date from left to right marks time, SpO2 value, PR value. Press “left button” or
“right button” to display the blood oxygen and pulse of the previous or next second; Long press the “left button” or
“right button”, and the pulse and blood oxygen will be display with a data interval of 10 seconds.
E. Press "up button" to exit the review Interface, return to the measure interface.
5.4 Clock interface
In the measure interface, press the "right button" can enter the clock interface of Figure 7. Press the "right button"
again can return to the measure interface.
Figure 7. Clock interface Figure 8. Main Menu Figure 9 Setting for sound prompt
5.5 Menu operations:
In the measure interface, press the "menu button "can enter the menu of Figure 8. Users can adjust the setting
through the main menu, such as the sound prompt, record, clock, system, etc. can be set, methods are as
followings:
5.5.1 Sound prompt setting
Under main menu, press the "up button" or "down button" to select “Prompt”, then press the "up button" or "down

button" to enter its setting interface shown in Figure 9.
Press the "up button" or "down button" to select the option to be adjusted, then press the "left button" or "right
button" to change the value.
“SpO2 HI(%)”: upper limit prompt for SpO2 over-limit
“SpO2 LO(%)”: lower limit prompt for SpO2 over-limit
“PR HI(bpm)”: upper limit prompt for PR over-limit
“PR LO(bpm)”: lower limit prompt for PR over-limit
“Prompt Sound”: prompt for over-limit, low-battery, finger out, sensor off and sensor fault, “off”: close, “on”:
open.
“Pulse Sound”: PR sound, “off”: close, “on”: open.
Lower limit can not exceed the upper limit, and the upper limit can not be lower than the lower limit when
adjusting the values. SpO2 range: 0 % ~ 100 %, PR range: 0 ~ 254 bpm
The values displayed in Figure 9 are the initial values of over-limit prompt.
After setting, press the "menu button" to exit the Prompt Settings Menu interface, and return to “Main Menu”
interface.
5.5.2 Data storage
Under the main menu, press the "up button" or "down button" to select “Record”, then press the "up button" or "down
button" to enter the “Record Menu” interface as shown in Figure 10.
Press the "up button" or "down button" to select the option to be adjusted, then press the "left button" or "right
button" to change the value.
It indicates that the device is storing when the red dot “REC ●” in measurement interface flickers.
“Mode”: record mode selection, including: “Auto” and “Manual” mode. Under “Manual” mode, select to turn on / off
memory by “Record ”.
Auto record: start recording after stable data appear, pull out the finger to finish recording a group of data (99 group of
data at most), the total duration does not exceed 72 hours.
Manual record: after manual storage is started, the storage state needs to be terminated manually to complete a group of
store, store up to 24-hour data.
When the memory is full, it will display “Memory is full!”, then it will enter the standby mode after several seconds.
When exiting the standby mode next time, it will display “Memory is full!” to prompt user that the memory has been
full.
Under manual mode, when “Record” is “ON”, the device will prompt to clear the data stored last time.
It will display “Recording...” when there is no operation under record state for 15s, then it will enter energy saving mode
after several seconds, pressing the "power on/off button", the device would return to the former interface; pressing
any button(power on/off excluded), it will display “Recording...”.
Under data recording state, after the display screen turns off automatically, in order to save power, pulse
sound indication will turn off automatically.
“Seg”: data segment.
After setting, press the "menu button" to exit storage menu, return to main menu.
“Delete All”: delete all records (auto record mode is shown as Figure 10).
Please upload data in time after recording, otherwise the data may be covered when the storage space is full.
The historical data will be deleted once switching the mode. Under record state, the record mode can not be
switched; under manual mode, the record mode can be switched only when turning off recording firstly.
Figure 10 Record menu Figure 11 Clock menu Figure 12 System menu
5.5.3 Clock setting
a. Connect the master device to synchronize device time
Under the PC software interface, after search for the device (refer to relative chapter (5.6) for the connection method), then
can synchronize the device time.
b. Set device time manually
Under main menu, press the "up button" or "down button" to select “Clock”, then press the "left button" or "right
button" to enter its setting interface shown in Figure 11.
Press the "up button" or "down button" to select the option to be adjusted, then press the "left button" or "right
button" to change the value.
“Set Time”: set the time, “yes”: allow, “no”: prohibit
“Set Year”: set the year
“Set Month”: set the month
“Set Day”: set the day
“Set Hour”: set the hour
“Set Minute”: set the minute
Adjustable range for year: 2015 ~ 2045, month: 1 ~ 12, day: 1 ~ 30 (when there are 31 days in a month, it is 1 ~ 31), hour: 1
~ 23, minute: 1 ~ 59.
After setting, press the "menu button" to exit clock menu, return to main menu.
5.5.4 System setting and other options introduction
Under main menu, press the "up button" or "down button" to select “System”, then press the "left button" or "right
button" to enter the interface as shown in Figure 12.
Press the "up button" or "down button" to select the option to be adjusted, then press the "left button" or "right
button" to change the value.
“Hard.Ver.”: hardware version
“Soft.Ver.”: software version
“ID”: user name
“Demo”: set the Demo mode, “on”: turn on the Demo mode, “off”: turn off the Demo mode.
“Sound Volume”: set the sound volume, adjustable range: 1 ~ 3
“Brightness”: set the screen brightness, adjustable range: 1 ~ 4
After setting, press the "menu button" to exit system setting menu, return to main menu.
5.5.5 Bluetooth setting (Bluetooth equipment)
Under main menu, press the "up button" or "down button" to select “Bluetooth”, then press the "left button" or "right
button" to enter its selection interface as shown in Figure 13 and Figure 14 When the Bluetooth is “ON’,if no data is
transmitted for some time, then the Bluetooth will be turned off automatically.
Under transmitting data by Bluetooth, the Bluetooth can not be turned off.
Figure 13 Bluetooth “ON” interface Figure 14 Bluetooth “OFF” interface
5.5.6 Exit main menu
Under main menu, press the "menu button" to exit the main menu and return to the measurement interface.
5.6 Data upload
A. Wired transmission
Connect the device to the computer by the USB cable, upload the data after connecting the PC software properly, refer to “Software
operating instruction” for details.
The PC software can be downloaded from our official website.
B. Bluetooth transmission (Bluetooth equipment)
Turn on the device Bluetooth and the PC software to upload data, refer to “Software operating instruction” for details.
5.7 Power off
Long press the "power on/off" button, until the device turns off.
when the device is in storing , it can’t be turned off.
6 Maintain, Transport and Storage
6.1 Cleaning and disinfection
The device must be turned off before cleaning, and it should not be immersed into liquid.
Please take out the internal battery before cleaning, do not immerse it into liquid.
Use 75% alcohol to wipe the device enclosure, nature dry or clean it with clean and soft cloth. Do not spray any liquid on the
device directly, and avoid liquid penetrating into the device.
6.2 Maintenance
A. Check the main unit and all accessories periodically to make sure that there is no visible damage that may affect patient’s
safety and monitoring performance. It is recommended that the device should be inspected weekly at least. When there is
obvious damage, stop using it.
B. Please clean and disinfect the device before/after using it according to the User Manual (6.1).
C. Please replace the batteries in time when low-battery appears.
D. Please take out the batteries if the device is not used for a long time.
E. The device need not to be calibrated during maintenance.
6.3 Transport and Storage
A. The packed device can be transported by ordinary conveyance or according to transport contract. During transportation, avoid
strong shock, vibration and splashing with rain or snow, and it can not be transported mixed with toxic, harmful, corrosive
material.
B. The packed device should be stored in room with no corrosive gases and good ventilation. Temperature: -40°C~+60°C;
Relative humidity: ≤95%.
7 Troubleshooting
Trouble Possible Reason Solution
The values can
not be displayed
normally or
stably.
1) The finger is not properly inserted.
2) The finger is shaking or the patient is
moving.
3) The device is not used in environment
required by the manual.
4) The device works abnormally.
1) Please insert the finger properly and
measure again.
2) Let the patient keep calm.
3) Please use the device in normal
environment.
4) Please contact the after-sales.
The device can
not be turned on
1) The battery is drained away or almost
drained away.
2) The battery is installed incorrectly.
3) The device’s malfunction.
1) Please change batteries.
2) Please Install the battery again.
3) Please contact the local service center.
The display
disappears
suddenly.
1) The device enters into the energy saving
mode.
2) Low battery.
3) The device works abnormally.
1) Normal.
2) Please change batteries.
3) Please contact the after-sales.
The data can not
be stored.
1） The device is not operated according to the
manual.
2） The device works abnormally.
1） Please operate the device according to the
manual.
2） Please contact the after-sales.
8 symbols
Symbols Meaning Symbols Meaning
Caution, consult accompanying
documents
left button/prompt pause button
%SpO2 pulse oxygen saturation (%)
Menu button
PRbpm Pulse rate (bpm)
Right button/clock button
Close the sound prompt
down button
Pause the sound prompt
Up button/replay button
Open the sound prompt
USB
Close the PR sound Type BF applied part
Open the PR sound Serial number
Finger Out The finger is not inserted.
1. The finger clip falls off ( no finger
inserted)
2. Probe error
3.Signal inadequacy indicator
Sensor Off The probe is disconnected. Sensor Fault Probe failure
The battery power is full Two grid of the battery
One grid of the battery
The lack of battery power.(Please change
batteries in time for exact measuring)
Alarm inhibit Manufacturer
Power on/off button Manufacture Date
Battery anode Battery cathode
Temperature limitation Atmospheric pressure limitation
Humidity limitation This way up
Fragile, handle with care Keep away from rain
IP22
It means this pulse oximeter is
protected against harmful effects of
dripping water when tilted at 15° Recyclable
Bluetooth: ON
(Bluetooth equipment)
Recycling garbage
WEEE (2012/19/EU)
This item is compliant with Directive
93/42/EEC of 14 june 1993 concerning
medical devices; Including, at 21 march
2010, the amendments by Council
Directive 2007/47/EC.
REC● Record state
European Representative Use-by date
LOT Batch No. P/N Material 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%;
0%~69%: unspecified.
Resolution 1%
PR
Display range 30 bpm ~ 250 bpm
Measured range 30 bpm ~ 250 bpm
Accuracy [see note 3] ±2 bpm during the pulse rate range of 30 bpm ~ 99 bpm and ±2%
during the pulse rate range of 100 bpm ~ 250 bpm.
Resolution 1 bpm
Accuracy under low perfusion [see note 4]
Low perfusion 0.4%:
SpO2: ±4%;
PR: ±2 bpm during the pulse rate range of 30 bpm ~ 99 bpm and
±2% during the pulse rate range of 100 bpm ~ 250 bpm.
Light interference Under normal and ambient light conditions, the SpO2 deviation ≤
1%
Pulse intensity Continuous bar graph display, the higher display indicates the
stronger pulse.
Upper and lower limit of measured values
SpO2 0% ~ 100%
PR 0 bpm ~ 254 bpm
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
Up to 99 group of data under auto mode, total duration does not
exceed 72 hours.
Up to 24-hour data under manual mode.
Safety class Internally powered equipment, type BF applied part
International Protection IP22
Working voltage DC 2.6 V ~ 3.6V
Working current ≤ 100 mA
Operation time The device can continuously work for 24 hours when it was
powered by two new batteries within the warranty period.
Power supply Dry battery (2AA)
Dimension and Weight
Dimensions 110(L) × 60(W) × 24(H) mm
Weight About 120g (with Dry battery(2AA))
Note 1: the claims of SpO2 accuracy shall be supported by clinical study measurements taken over the full range. By
artificial inducing, get the stable oxygen level to the range of 70 % to 100 % 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.
Appendix
State Sound prompt condition delay Sound prompt signal generation delay
Low voltage sound prompt 1s 20ms
SpO2 sound prompt 330ms 20ms
Pulse rate sound prompt 330ms 20ms
Probe error sound prompt 16ms 20ms
EMC
Table 1:
Guidance and manufacturer’s declaration –electromagnetic emission
The Pulse Oximeter is intended for use in the electromagnetic environment specified 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
Table 2:
Guidance and manufacturer’s declaration-electromagnetic immunity
The Pulse Oximeter is intended for use in the electromagnetic environment specified 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
±8kV contact
± 15 kV air
±8kV contact
±15kV air
Power frequency (50 / 60Hz)
magnetic field
IEC 61000-4-8
30 A/m 30A/m
Table 3:
Guidance and manufacturer’s declaration – electromagnetic immunity
The Pulse Oximeter is intended for use in the electromagnetic environment specified 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
Radiated RF
IEC61000-4-3 10 V/m 80 MHz- 2.7 GHz 10 V/m80 MHz- 2.7 GHz
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the Pulse Oximeter is used exceeds the applicable RF compliance level above, the Pulse Oximeter
should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the Pulse Oximeter.
b Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3V/m.
Table 4:
Guidance and manufacturer’s declaration - electromagnetic Immunity
The [Code SI] is intended for use in the electromagnetic environment specified below. The customer or the user of the Pulse
Oximeter should assure that it is used in such an environment
Radiated RF
IEC61000-4-
3
(Test
specification
s for
ENCLOSU
RE PORT
IMMUNITY
to
RF wireless
communicati
ons
equipment)
Test
Frequency
(MHz)
Band a)
(MHz) Service a) Modulation b)
Modulation
b)
(W)
Distance
(m)
IMMUNITY
TEST LEVEL
(V/m)
385 380 –390 TETRA 400
Pulse
modulation b)
18 Hz
1,8 0,3 27
450 430-470 GMRS 460,
FRS 460
FM c)
± 5 kHz
deviation
1 kHz sine
2 0,3 28
710
704 – 787 LTE Band
13,17
Pulse
modulation b)
217 Hz
0,2 0,3 9
745
780
810
800 – 960
GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulation b)
18 Hz
2 0,3 28
870
930
1720
1700 –
1990
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1,
3,4,25; UMTS
Pulse
modulation b)
217 Hz
2 0,3 28
1845
1970
2450 2400 –2570
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
Pulse
modulation b)
217 Hz
2 0,3 28
5240
5100 –5800 WLAN 802.11
a/n
Pulse
modulation b)
217 Hz
0,2 0,3 9
5500
5785
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:
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.

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 specified or provided by the manufacturer of this
equipment could result in increased electromagnetic emissions or decreased electromagnetic 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 specified 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 fluctuate, please measure repeatedly or in another
environment to ensure its accuracy.
Bluetooth Specification
Working frequency: 2402 MHz ~ 2480 MHz
Modulation mode: GFSK
Transmitting power: 0 dBm, +4 dBm
Receiving sensitivity: -93 dBm