2BEYI-LITEXIM Pulse Oximeter Instruction Manual

2BEYI-LITEXIM Pulse Oximeter

Specifications

• Bluetooth connectivity for data transmission
• Compatible with a dedicated mobile application
• Pulse frequency display range: 25 to 300 PR/min
• SpO2 historical data tracking
• Pulse rate historical data tracking
• Respiration rate historical data tracking

Bluetooth and App Connection
Ensure Bluetooth is enabled on your device. Open the dedicated mobile application and follow the on-screen instructions to pair the device with the app.

Interface Description
The interface displays pulse frequency, SpO2 data, pulse rate history, respiration rate history, and a timeline of historical data.

Pulse Frequency Display
The pulse frequency is displayed in PR/min. Valid range: 25 to 300 PR/min. An invalid value is indicated by “—“.

Historical Data Viewing
Swipe left and right on the app to view historical SpO2, pulserate, and respiration rate data.

Time Axis of Historical Data:
The historical data is presented with timestamps indicating the time of occurrence and duration of events.

FAQ (Frequently Asked Questions)
Q: What should I do if the device does not connect via Bluetooth?
A: Make sure Bluetooth is enabled on your device and that the device is within range. Restart both the device and the mobile app, then attempt to reconnect.

Instruction manual

• patients’ SpO? and pulse rate, please clip the thick finger such as thumb and middle finger deeply enough into the probe. (29)The update period of data is less than 5 seconds, which is changeable according to different individual pulse rate. (30)Please read the measured value when the waveform on screen is equably and steady-going, This measured value is optimal value. (31)If some abnormal conditions appear on the screen during test process, pull out the fingerand reinsert to restore normal use. (32)The device has normal useful life for three years since the first electrified use. (33)The device has the function of limits alarming, when the measured data is beyond thehighest or lowest limit, the device would start alarming automatically on the premise of the alarming function is on. (34) The device may not work for all patients. If you are unable to achieve stable readings, discontinue use. (35)A flexible circuit connects the two parts of the device. Do not twist or pull on the connection. (36) Take out batteries if the equipment is not used for a long time. (37)Properly carry the equipment and prevent it from falling, collision, strong vibration or other mechanical external force damage.
• (13)The measured value of blood oxygen saturation is for reference only to anaemic hypoxia and toxic hypoxia. Some patients with severe anemia may still have higher measured value of blood oxygen saturation due to physiological reasons. (14)As the measure is taken on the basis of arteriole pulse,substantial pulsating blood flow of subject is required. For a subject with weak pulse due to shock, low ambient/body temperature, major bleeding, or use of vascular contracting drug, the SpO waveform (PLETH) will decrease. In this case, the measurement will be more sensitive to interference.

INSTRUCTIONS TO USER

Dear Users, thank you very much for purchasing our product. The Manual is written for the current Pulse Oximeter. in case of modifications and software upgrades, the information contained in this document is subject to change without notice. The Manual describes. in accordance with the Pulse Oximeter’s features and requirements, main structure, functions, specifications, correct methods for transportation, installation, usage, operation, repair, maintenance and storage, etc.as well as the safety procedures to protect both the user and equipment. Refer to the respective chapters for details. Please read the Manual very carefully before using this equipment. These instructions describe the operating procedures to follow these instructions can cause measuring abnormality, equipment damage and personal Injury. The manufacturer is not responsible for the safety, reliability and performance issues and any monitoring abnormality, personal injury and equipment 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.

.SAFETY INFORMATION

Warning

1. Only qualified personnel designated by the manufacturer is allowed to maintain the equipment. Users themselves are not allowed to repair the equipment
2. Explosion hazard: not use the equipment in environment with inflammable substances such as anesthetics.
3. Not use the equipment in MRI and CT examination.
4. When used with electrosurgical equipment together, the user shall ensure the safety of the monitored patient.
5. Users who are allergic to silicone rubber is forbidden to use this equipment.
6. The equipment, accessories and packaging (batteries, plastic bags, foam and cartons, etc.) shall be scrapped in complance win local lavs and regulations.
7. Forbid to use the equipment once the equipment is found damaged, or have material deterioration.
8. Do not use the equipment under the application conditions beyond its declared specification scope.
9. When using the equipment for long-term continuous monitoring, check and replace measured parts at least every 2 hours. It is necessary for more frequent exammations in some scendrios, such as pertusion disorders and skin sensitivity. Prolonged monitoring may increase unpredictable skin changes, such as allergies, reddening, blistering, or compressive necrosis.
10. For the special patients, there should be a more prudent inspecting in the placing process.The device cannot be clipped on the edema and tender tissue.
11. The light (the infrared is invisible) emitted from the device is harmful to the eyes, so theuser and the maintenance man should not stare at the light.
12. Testee cannot use enamel or other makeup.
13. Testee’s fingernail cannot be too long
14. Ensure that the environment in which the device is operated is not subject to any sources of strong electromagnetic interference, such as radio transmitters, mobile telephones, etc. Keep them far away High level electromagnetic radiation emitted from such devices may greatly affect the monitor performance.
15. Be careful with the use of the lanyard cord. Improper use of the lanyard cord will cause device damage not covered under the manufacturer’s warranty. Swinging the device by the lanyard cord will void the warranty. Please do not use lanyard cord if allergic to lanyard cord.
16. Please choose the accessories and probe which are approved or manufactured by the manufacturer, or else it may damage the device.
17. Please don’t measure this device with functional tester for the device’s related information
18. When uploading, do keep the patient form touching the USB port. The computer used when uploading must be in accordance with EN60950.We recommended to use Lenovo Qitian M320,etc,in addition, when the data lineconnected to a computer, the medical electrical systems should be in accordance with IEC60601-1-1
19. It is not recommended to use the equipment in electric knife and other high frequency interference environment.
20. Children are not recommended to operate the equipment directly and they must operate the equipment under adult supervision.
21. Keep the application environment free of dust, vibration, corrosion or combustible substances, and avoid temperature and humidity too high or too low.
22. Turn off the equipment immediately if water splash the equipment or there is condensate in the equipment.
23. Do not use the equipment immediately when it is transferred from cold environment to warm and humid place.
24. There is a visual indicator of low battery capacity in the equipment. Replace batteries in time when the low battery indicator appears.
25. High temperature or high pressure steam disinfection of the Pulse Oximeter is not permitted.
26. Do not have the Pulse Oximeter immerged in liquid. When it needs cleaning, please wipe itssurface with medical alcohol by soft material. Do not spray any liquid on the device directly.
27. When cleaning the device with water, the temperature should be lower than 60°C.
28. As to the fingers which are too thin or too cold, it would probably affect the normal measure of the  patients’ SpO? and pulse rate, please clip the thick finger such as thumb and middle finger deeply enough into the probe.
29. The update period of data is less than 5 seconds, which is changeable according to different individual pulse rate.
30. Please read the measured value when the waveform on screen is equably and steady-going, This measured value is optimal value.
31. If some abnormal conditions appear on the screen during test process, pull out the fingerand reinsert to restore normal use
32. The device has normal useful life for three years since the first electrified use.
33.  The device has the function of limits alarming, when the measured data is beyond thehighest or lowest limit, the device would start alarming automatically on the premise of the alarming function is on.
34.  The device may not work for all patients. If you are unable to achieve stable readings, discontinue use
35. A flexible circuit connects the two parts of the device. Do not twist or pull on the connection.
36. Take out batteries if the equipment is not used for a long time.
37. Properly carry the equipment and prevent it from falling, collision, strong vibration or other mechanical external force damage.

OVERVIEW

The pulse oxygen saturation is the percentage of Hb02 in the total Hb in the blood, so-called the 02 concentration in the blood. It is an important bio- parameter for the respiration. For the purpose of measuring the SpO more easily and accurately, our company developed the Pulse Oximeter. At the same time, the device can measure the pulse rate simultaneously. The Pulse Oximeter features in small volume, low power consumption, convenient operation and being portable. It is only necessary for testee to put one of his fingers into a fingertip photoelectric sensor for diagnosis, and a display screen will directly show measured value of Hemoglobin Saturation.

Features
Operation of the product is simple and convenient. The product is small in volume, light in weight(total weight is about 28g including batteries Jand convenient in carrying. Power consumption of the product is low and the two originally equipped AAA batteries can be operated continuously for 20 hours. The product will enter standby mode when no signal is in the product within 5 seconds. Display direction can be changed, easy to view.

Major Applications and Scope of Application
The Pulse Oximeter can be used to measure human Hemoglobin Saturation and pulse rate through finger, and indicate the pulse intensity by the bar display. The product is suitable for use in family, Oxygen Bar, social medical organizations and also the measure of saturation oxygen and pulse rate.

Environment Requirements Storage Environment

Storage Environment

• Temperature: -40°C~+60°C
• Relative humidity: <95%
• Atmospheric pressure: 500 hPa~1060 hPa

Operating Environment

• Temperature: 10°C~40°C
• Relative Humidity: ≤75%
• Atmospheric pressure: 700 hPa~1060 hPa

PRINCIPLE AND CAUTION

Principle of Measurement
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 (Hb02) in glow & near-infrared zones. Operation principle of the instrument is: Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning Recording Technology, so that two beams of different wavelength of lights can be focused onto human nail tip through perspective clamp finger- type sensor. Then measured signal can be obtained by a photosensitive element, information acquired through which will be shown on screen through treatment in electronic circuits and microprocessor.

Measurement Precautions

1. Please check the device before using, and confirm that it can work normally.
2. The SpO sensor and photoelectric receiving tube should be arranged in a way with the subject’ sarteriole in a position there between.
3. The SpO sensor should not be used at a location or limb tied with arterial canal or blood pressurecuff or receiving intravenous injection.
4. Do not fix the SpO sensor with adhesive or else it may result in venous pulsation and inaccurate.
5. Put the proper finger into the
6. Pulse Oximeter. The measured value may be affected if the finger is too cold or thin.
7. The finger shall be inserted to the finger clip cavity deeply enough, and otherwise, the measured value may be inaccurate. Ensure the light between the photoelectric receiving tube and the luminescent tube of the Pulse Oximeter shall passes through the small artery bed of the finger of the subject.
8. Keep the place where the light path passes free from light barriers such as adhesive tape to ensure the accuracy of parameter measurement.
9. The product is suitable for children and adults with finger thickness of 7mm~25.4mm.
10.  The measurement will be affected by excessively strong ambient light, including but not limited to fluorescent lamp, double Ruby lamp, infrared heater, direct sunlight, etc.
11. The measurement accuracy will be affected if the subject performs strenuous activities.  interference of electrical surgical equipment may affect the measurement accuracy.
12. The nail on the test site shall be free from nail polish and other cosmetics. To ensure measurement accuracy, remove nail polish or other cosmetics if any.
13. The measured value of blood oxygen saturation is for reference only to anaemic hypoxia and toxic hypoxia. Some patients with severe anemia may still have higher measured value of blood oxygen saturation due to physiological reasons. (14)As the measure is taken on the basis of arteriole pulse,substantial pulsating blood flow of subject is required. For a subject with weak pulse due to shock, low ambient/body temperature, major bleeding, or use of vascular contracting drug, the SpO? waveform (PLETH) will decrease. In this case, the measurement will be more sensitive to interference.

BLUETOOTH AND APP

Download instructions

1. .Scan the code and install the app, as shown in the figure below. (If you scan the QR code and click Install, you cannot download it. You can choose to open it in the browser and download it.)
   http://narisa.co/rem/apes/arica/en/aid/download.html (Android)

Operation interface description

Click the” connect to device” button. Then switch to the measurement interface.

1. Unit of blood oxygen saturation: Sp02%.
2. Measured value of blood oxygen. saturation: the display range is [1~100] and the sign “–” means invalid value
3.  Unit of pulse rate: PR/min.
4. When the unit of pulse rate
5. ights up, display the measured value of pulse rate. The display range of pulse rate is [25 ~ 300] and the sign “—” means invalid value.
6.  Home.

Click the”History” button. Then switch to the historic data view

interface.

1. Unit of blood oxygen saturation: SpO%

2. SpO? historical data. Swipe left and right to view historical data. 3. Unit of pulse rate: PR/min

3. PR historical data. Swipe left and right to view historical data.

4. Unit of respiratory rate: RR / min

5. RR historical data. Swipe left and right to view historical data.

6. Historical data timeline

7. Historical Data menu

8. Click the” button to see historical hypoxemia occurrence time

9. Historical oxygen drop events: Hypoxemia and Insufficient blood perfusion

10. Time of event

11. Duration

The parameters of the oximeter can be set through the following menu.

1. Patient type setting. Including: adult children
2. Response speed setting. Including: Rapid, Normal,slow
3. Sensitivity setting. Including: low,Middle, High.
4. Delete all Historical Data
5. Device search list

ACCESSORIES

One hanging rope and One User Manual

INSTALLATION

Screen and product installation

Battery Sater
prope fy ine a right insect the two AAA size Step 2. Replace the cover.

Please take care when you insert the batteries for the improper insertion may damage the device.

Mounting the Hanging Rope

1. Step 1. Put the end of the rope through the hole.
2. Step 2. Put another end of the rope through the first one and then tighten it.

OPERATING GUIDE

1. Insert the two batteries properly to the direction, and then replace the cover.

2. Open the clip as shown in Figure 8.

3. Let the testee finger put into the rubber cushions of the clip (make sure the finger is in the right position), and then clip the finger

4.  Press the button once on front panel.

5. Do not shake the finger and keep testee ease during the process. Meanwhile, human body is not recommended in movement status.

6.  Get the information directly from screen cisolav. Tithe button has two functions. When the device is in device is in operation status, pressing the button long can change urigntness of the scroch.

7. The device could chance d solsy direction according 10 the nanding airccoon,

REPAIRING AND MAINTENANCE

Please chance the batteries when the love voltsoe dissolved. Please clean the suriace of the cevice before using. Wind the device with medical a cone. first and then let it dry in sin Using the alcohol to disintee the product aner Use, prevent from cross intection for next ame use. a long name Ine best storage environment of the device is-‘t to bu° ambient temperature and not higher than Jo% relative numidity or according to the calibrating program of hospital). It also. can be performed at the state-appointed agent or just contact us for calibration

TROUBLESHOOTING

KEY OF SYMBOLS

TECHNICAL SPECIFICATIONS

1.  Type: Finger clip
2. Response Time: <5s
3. Battery: 2x AAA
4. Operating temperature:
5. C~40°C 5. Storage temperature: -10°C~50°C
6.  Hemoglobin saturation (Upper limit: 100 / Bottom limit:94)
7. Pulse rate limit (Upper limit:130 / Bottom limit:50)
8.  Hemoglobin saturation display: 35~100%
9. Pulse rate display: 25~250 BPM
10.  Dimension: 61.8 x34.2 x33.9mm / 62.7 x32.5 x29.1 mm
11. Net Weight: 27.8g

FUNCTION SPECIFICATION

Dongguan Lingxin Technology Co., Ltd. Address: Room 301
,No.3 Liantang Road,aoshitang,Dongcheng Street, Dongguan City, Guangdong Province, 523125,
P.R.C Tel: +86 189 2646 3069 Email: sales@guangsudu.net

MADE IN CHINA
Name: MedPath GmbH Address: Mies-van-der-Rohe-Strasse 8,80807 Munich, Germany

• Telephone:+49(0)89 189174474
• Fax: +49(0)89 5485 8884
• E-Mail: info@medpath.pro

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