INSTRUCTION MANUALFOR CITIZEN PULSEOXIMETER CMS50DL1

Caution:Thank you very much forpurchasing the CITIZEN PULSEOXIMETER• Please read all of theinformation in this instruction
manual before operating thedevice.
• Be sure to have this instruction
manual to hand during use.

Rev.2401
Date of issue: 2024/2/15

T he Pulse Oximeter is used to measure
Oxygen Saturation (SpO2) and pulse rate
through finger, and indicate the pulse
intensity by the bar-display.
• Intended operator:	The device is suitable for persons weighing
more than 40 kg.

• Intended use:

Safety Precautions

Be sure to read the following instructions before using the device.

Warning:

Indicates a potentially hazardous situation which it may
result in death or serious injury.
• Consult your physician before using the device. Do not use
measurement results for self-diagnosis and self-treatment.
Always consult your physician.
• If the battery fluid gets in your eyes or on your skin, rinse it off
with water immediately and then receive treatment from yourphysician.
• Do not use the device in the vicinity of flammable gases such as
those used for anesthesia. It could ignite the gases and cause an
explosion.
• Do not use the device while examining by MRI or CT, as theinduced current may cause burn.
• Do not take the information displayed on the device as the solebasis for clinical diagnosis. The device should only be used as an
auxiliary means in diagnosis. And it must be used in conjunction
with the doctor’s advice, clinical manifestations, and symptoms.
• Do not remove the lanyard to avoid dropping the device andcausing damage. The lanyard is made of insensitive material. Do
not use it if any person is allergic to the lanyard. Do not wrap thelanyard around your neck to avoid accidents.
• Check the device before use to make sure that there is no visible
damage that may affect the user’s safety and device
performance. When there is obvious damage, do not use it andplease contact distributor.
• When using the device, keep it away from equipment that cangenerate strong electric or magnetic fields. Using the device in
an inappropriate environment may cause interference tosurrounding radio equipment or affect its working.
• Using several products on the same patient simultaneously may
be dangerous due to the overlap of leakage current.
• CO poisoning is shown as an over-estimation, so it is notrecommended to use the device for this purpose.

CMS50DL1_IM_2401_EN.indd 1• An uncomfortable or painful feeling may appear if the device isused for a long period, especially for users with a microcirculation
disturbance. It is not recommended to use the sensor on the same
finger for more than 2 hours.
• For some special users who need a more careful inspection on thetest site, do not place the device on the edema or tender tissue.
• Do not stare at the red or infrared light emitter (the infrared light isinvisible) after turning on the device, including 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 therequirements in ISO 10993-1, and it has passed the recommended
biocompatibility test. Persons who are allergic to silicone, PVC,
TPU, TPE or ABS cannot use this device.
• The device cannot be used with equipment not specified in the
Manual. Only accessories appointed or recommended by the
manufacturer can be used. Failure to observe this instruction may
cause injury to the tester and operator or damage to the device.
• Measured accuracy is affected by interference from electrosurgicalequipment.
• Measurement can be affected by or unreliable readings may result
from– fingers are too thin, having too long fingernails– lotions, nail polish and unclean fingertip– strong lights such as sun light or surgical light• Measurement cannot be taken correctly If your fingertip is cold.
Before making a measurement, warm your finger by massaging
etc. to improve the blood flow.
• Do not attempt to disassemble, repair or modify the device.
• If the device is splashed or coagulated with water, stop operating
and do not expose the device to water.
• Before using the device, make sure that it is in a normal working
state and is located in a normal operating environment.
• In order to obtain more accurate measurements, the device
should be used in a quiet and comfortable environment.
• Do not use the device immediately after it has been carried from acold environment to a warm or humid environment.
• Do not operate the device using a sharp object.
• Do not twist or drag the device wire.
• There is no alarm function. Do not use the device if you need an
alarm.
• Do not drop the device and give any shocks or vibrations.

Symbol Explanations
Refer to instruction manual before use.

Overview

Alarm inhibit

Indicates a potentially hazardous situation which it may
result in injury or property damage. The property damagerefers to consequential damage to buildings, household,belongings, livestock, and pets.

2012/19/EU WEEE
Please do not dispose of the product in the household
waste at the end of its useful life.
Disposal can take place at appropriate collection points
provided in your country.
To protect the environment, dispose of empty batteries atyour retail store or at appropriate collection sites
according to national or local regulations.
IP22

Protection level of solid particle and liquid ingress
Paper Recycling
Manufacturer
Name: C ontec Medical Systems Co., Ltd.
Address: No.112 Qinhuang West Street, Qinhuangdao,
Hebei Province, P.R. China

Oxygen Saturation (SpO2) 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 andcirculatory system.
A number of diseases related to respiratory system may cause thedecrease of SpO2 in the blood, furthermore, some other causessuch 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 inhuman body, and the corresponding symptoms would appear asa 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 theclinical medical field. Insert the finger when measuring, the device
will directly display the SpO2 value measured.

Date of manufacture
SN

Serial number
Authorized representative in the European cummunity
Name: P
 rolinx GmbH
Address: Brehmstr. 56,40239 Duesseldorf, Germany
Tel: 0049 211 3105 4698
E-mail: med@eulinx.eu

INSERT THE BATTERIES
1. Slide open the battery cover on the bottom of the device.

0123 The CE mark and Notified Body Registration Numbers

Names of Parts
The device and its accessories
DeviceButtonMake sure that the
package contains all
the following items.
• Device• Instruction manualand EMC technicaldata• Test Batteries• Lanyard

2. Be sure to inset the batteries into negative side with the
protruding springs first so as not to mix up the positive andnegative terminals.
3. Align the “▲” mark on the main unit with the “▼” mark on thebattery cover. Slide the battery cover so that the “▲” mark on
the main unit aligns with the “I” mark on the battery cover.

Screen Display

Pulse rate value
SpO2 value
Battery’s low
voltage indicator

Pulse rate bar graph* The device does not have low-voltage prompt function, it onlyshows the low-voltage, please change the battery when thebattery voltage is used up.
* Do not use any other type of battery except alkaline.
* Do not mix up the kind of batteries.

Type BF applied part
Warning
Caution

29/2/2024 1:21:46 PM

Attach the lanyard

Maintain, Transport and Storage

Function Specification

1. Put the end of the loop in the hole.

Cleaning and disinfection
The device must be turned off before cleaning, and should not be
immersed in liquid.
Take out the internal batteries before cleaning, and do not immerse
it in liquid.
Use 75% alcohol to wipe the device enclosure and use liquid soap
or isopropanol to wipe the display for disinfection. Allow it to dry
naturally or clean it with clean and soft cloth. Do not spray any
liquid on the device directly and do not let liquid penetrate into thedevice.
Maintenance
A. Check the main unit and all accessories periodically to make surethat there is no visible damage that may affect patient’s safety
and measurement performance. It is recommended that thedevice should be inspected weekly at least. When there is
obvious damage, stop using it.
B. Clean and disinfect the device before/after using it according to
the User Manual.
C. Replace the batteries promptly when the low-battery indication
appears.
D. Remove the batteries if the device will not be used for a longtime.
Transport and Storage
A. The packaged device can be transported by ordinary conveyanceor according to transport contract. During transportation, avoid
strong shock, vibration and splashing with rain or snow. The
device cannot be transported together with toxic, harmful, or
corrosive materials.
B. The packaged device should be stored in a room with nocorrosive gases and good ventilation.
Temperature: -40°C~+60°C; Relative humidity: ≤95%.

SpO2 (*1)
Display range
Measured range
Accuracy (*2)

2. Put another end of the loop through the first one and thentighten it.

Measuring value
1. Open the clip as shown below.

2. Place the patient’s finger on the rubber cushions of the clip (makesure the finger is in the right position), and then clip the finger.
* Please insert the thicker finger such as thumb or middle finger
deeply enough into the probe when measuring.

Troubleshooting
Trouble3. Press the button on the front panel once.
4. Do not shake the finger and keep the patient at ease during theprocess. It is recommended that the patient stays still during themeasurement.
5. Read the information directly from the screen display.
* Fingernails and the luminescent tube should be on the same side.

Pulse rate is valued at 75 bpm
SpO2 is valued at
98 %The bar indicates pulse
intensity

Solution1) I nsert the finger
properly and measureagain.
2) H elp the patient stay
calm.
3) U
 se the device in theproper environment.
4) C ontact the distributor.

The SpO2
and Pulse
Rate are notdisplayedstably1) The finger is not placed
inside deep enough.
2) The finger is shaking or thepatient is moving.

1) P lace the finger
properly and try again.
2) H elp the patient staycalm.

The device
cannot be
turned on1) The battery is drained or
almost drained.
2) The battery is installed
incorrectly.
3) The device is faulty.

1) C hange the batteries.
2) I nsert the batteries
again.
3) C ontact the distributor.

The display
turns off
suddenly

1) The device has enteredenergy saving mode.
2) L ow battery.
3) The device is faulty.

1) The device is working
properly.
2) C hange the batteries.
3) C ontact the distributor.

* After pull out your finger, the device enteres into energy saving mode.

CMS50DL1_IM_2401_EN.indd 2

Possible Reason1) The finger is not properly
inserted.
The SpO2
2) The finger is shaking or theand Pulse
patient is moving.
Rate cannot3) The device is not being used
be displayedin the environment required
normally
by the manual.
4) The device is faulty.

Resolution
Pulse rate
Display range
Measured range
Accuracy (*3)
Resolution
Accuracy under
low perfusion (*4)
Light interference
Red light (*5)
Infrared light (*5)
Safety classOperatingenvironment
Storageenvironment
International
Protection
Working voltage
Working current
Power supply
Battery life
Service life
Dimension
Weight0%SpO2 ~ 99%SpO2
0%SpO2 ~ 100%SpO2
70%SpO2 ~ 100%SpO2: ±2%SpO2;0%SpO2 ~ 69%SpO2: unspecified.
1%SpO230 bpm ~ 250 bpm
30 bpm ~ 250 bpm±2 bpm or ±2%, whichever is greater.
1 bpm
Low perfusion 0.4%:
SpO2: ±4%SpO2;
Pulse rate: ±2 bpm or ±2%, whichever is greater
Under normal and ambient light conditions,
the SpO2 deviation ≤ 1%SpO2
Wavelength: about 660 nm, optical output power: < 6.65 mW
Wavelength: about 905 nm, optical output power: < 6.75 mW
Internally powered equipment, type BF applied part
Temperature: +10°C~+40°C
Relative humidity: ≤75%
Atmospheric pressure: 700hPa~1060hPa
Temperature: -40°C~+60°C
Relative humidity: ≤95%
Atmospheric pressure: 500hPa~1060hPa
IP22
DC 2.6 V ~ 3.6 V≤ 25 mA
1.5V (AAA (LR03)size) alkaline batteries × 2
Two batteries can work continually for 24 hours
3 years
61 (L) × 36 (W) × 32 (H) mm
Approximately 55g (with the batteries)* 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 therange of 70 % to 100 % SpO2, compare the SpO2 values collected by thesecondary standard pulse oximeter equipment and the tested equipment at
the same time, to form paired data, which are used for the accuracy analysis.
There are 12 healthy volunteers (male: 6. female: 6; age: 18~45; skin color: black:2, light: 8, white: 2) data in the clinical report.
* 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.
* 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 thevalue set by simulator.
* 4: Percentage modulation of infrared signal as the indication of pulsating signal
strength, patient simulator has been used to verify its accuracy underconditions 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.
* 5: Optical sensors as the light-emitting components, will affect other medical
devices applied the wavelength range. The information may be useful for theclinicians who carry out the optical treatment. For example, photodynamic
therapy operated by clinician.
This device corrsponds to the below standards:
IEC 60601-1/EN 600601-1 (Medical electrical equipment - Part 1), IEC 60601-1-2/
EN 60601-1-2 (Medical electrical equipment - Part 1-2), ISO 80601-2-61 (Medical
electrical equipment - Part 2-61 )29/2/2024 1:21:47 PM