MOBICLINIC Fingertip Pulse Oximeter Pulse Oximeter Blue Instruction Manual

MOBICLINIC Fingertip Pulse Oximeter Pulse Oximeter Blue

Product Information

• Product Name: Fingertip Pulse Oximeter
• Manufacturer: Spanish Leading Company
• Year of Establishment: 1985
• Features: Non-invasive and continuous measurement of artery SPO2 and PR
• Usage: Portable device for quick and precise measurement of SPO2 and PR values
• Indications: Can be used in hospitals, families, schools, and medical centers
• Precision and Repeatability: Possesses high precision and repeatability.

Product Usage Instructions

1. Make sure   the device is in standby mode.
2. Place your finger on the device’s infrared-ray receiving tube.
3. Press the start button to put the device into operating mode.
4. The OLED display will show the SPO2 and PR values.
5. To change the display mode, press the start button during operation.
6. To set up parameters, press the power button again (less than 1 second) to scroll down the mode you want to set up. The signal will move each time you press the power button. Press the power button more than 3 seconds to start setting up. Move the signal on the Alm Setup, press the power button more than 3 seconds to enter the second page settings.
7. Follow the instructions on the display to set up the desired parameters.
8. The device can measure SPO2 in the range of 70% to 99%.
9. The device can operate in an ambient humidity range of 15% to 80%.
10. The device comes with a lanyard for hanging it around the neck.
11. The device is powered by two AAA batteries.
12. For more detailed information and troubleshooting, consult the user manual. Please note that the information provided above is specific to the product mentioned and may not be applicable to other models or brands. Always refer to the user manual for accurate instructions and guidelines.

FINGERTIP PULSE OXIMETER

This Fingertip Pulse Oximeter is a kind of innovated medical device with non- invasive and continuous features for artery SPO2 and PR detection. Being portable, it is able to measure SPO2 and PR values quickly and precisely

NOTICE
Notice to the user and/or patient: any serious incident which has occurred in relation to the device must be reported to the manufacturer and to the competent authority of the Member State in which the user and/or patient is established.

INDICATIONS
The finger pulse oximeter can be used to measure human haemoglobin saturation and pulse rate through the finger, can be used in hospitals, families, schools and medical centres.

GENERAL DESCRIPTION

Hemoglobin Saturation is the percentage between the capacity of Oxyhemoglobin (HbO2) that in compounded with oxygen and that of all combinable hemoglobin (HbO2) in blood. In other words, it is the saturation of Oxyhemoglobin in blood. It is a very important physiological parameter for Respiratory and Circulation Systems. Many respiratory diseases could reduce hemoglobin saturation in human blood. Moreover, factors such as Automatic Organic Regulation Malfunction caused by anesthesia, trauma resulted from major operation and some medical examination can also cause problems in oxygen supply, which might reduce human hemoglobin saturation. As a result, such symptoms as megrim, vomiting and asthenia might appear to patients. Hence, it is very important to know hemoglobin saturation of patient timely in clinical medical aspects.
The Fingertip pulse oximeter features in small volume, low power consumption, convenient operation and portability. It is only necessary that the patient puts one finger into the fingertip photoelectric sensor for diagnosis, and the display screen will directly show measured value of hemoglobin saturation. It has been proved in clinical experiments that it  possesses rather high precision and repeatability.

MEASUREMENT PRINCIPLE

The principle of the oximeter is as follows: An experience formula of data process is established by exerting Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive hemoglobin (R Hb) and oxyhemoglobin (O2 Hb) in glow and near-infrared zones. Operation principle of the instrument is to combine Photoelectric Oxyhemoglobin Inspection Technology with Capacity Pulse Scanning and Recording Technology, so that two lights with different wavelength (660nm glow and 940nm near infrared light) can be focused onto human nail through perspective clamp finger-type sensor. Then measured signal can be obtained by a photosensitive element, information acquired through which will be shown on two groups of LEDs through process in electronic circuits and microprocessor.

Diagram of Operation Principle

1. Infrared-ray receiving tube
2. Infrared-ray transmitting tube

PRECAUTIONS FOR USE

1. Do not use the pulse oximeter together with MRI or CT equipment.
2. Explosion hazard: Do not use the pulse oximeter in an explosive atmosphere.
3. The pulse oximeter is intended only as an adjunct in patient assessment. Doctors should make diagnosis in conjunction with clinical manifestation and symptoms.
4. Check the pulse oximeter sensor application site frequently to make sure that the circulation and skin integrality of patient are under good condition.
5. Do not stretch the adhesive tape while applying the pulse oximeter  sensor. This may cause inaccurate reading or skin blisters.
6. Please read the manual carefully before your operation.
7. The pulse oximeter has no SpO2 prompt, it is not for continuous monitoring.
8. Prolonged use or the patient’s condition may require changing the sensor site periodically. Change sensor site and check skin integrality, circulatory status, and correct alignment at least every 2 hours.
9. Inaccurate measurements may be caused by autoclaving, ethylene oxide sterilizing, or immersing the sensors in liquid.
10. Significant levels of dysfunctional hemoglobin (such as carboxyl- hemoglobin or methemoglobin) may cause inaccurate reading.
11. Intravascular dyes such as indocyanine green or methylene blue may cause inaccurate reading.
12. SpO2 measurements may be adversely affected in the presence of high ambient light. Please shield the sensor area (with a surgical towel or direct sunlight, for example) if it is necessary.
13. Unexpected action may cause inaccurate reading.
14. Medical signal with high frequency or interference caused by defibrillator may lead to inaccurate reading.
15. Venous pulsations may cause inaccurate reading.
16. It may cause inaccurate reading when the positions of sensor and blood pressure cuff are on the same arterial catheter or intravascular line.
17. Hypotension, severe vasoconstriction, severe anemia, or hypothermia may cause inaccurate reading.
18. It may cause inaccurate reading by giving use of cardiotonic to patient after his cardiac arrest or when he is in quiver.
19. Bright nail or painted nail may cause inaccurate SpO2 reading.

Follow local ordinances and recycling instructions regarding to disposal or recycling of the device and device components.

Scope of application / intended use
The Fingertip pulse oximeter is suitable for children under 12 years old to detect blood oxygen saturation and pulse rate, it can be used in hospitals, families, schools and medical centers.

FEATURES

• Product adopts double color OLED display can show the six different display mode
• Low-power consumption, continuously work for more than six hours with  one rechargeable lithium battery
• Battery power indicator
• In the absence of signals, the product will be in after 8 seconds to power-off automatically
• Small in volume, light in weight, and convenient to carry

OPERATION INSTRUCTIONS

1. Hold the lock button on the battery cover, push the battery cover down at the same time and the battery cover is opened.
2. Install two AAA batteries into battery cassette before closing its cover.
3. Plug one finger into the rubber hole of the oximeter (it is best to plug the finger thoroughly), before releasing the clamp with the nail upwards.
4. Press the button on the front panel.
5. Don’t tremble with your finger when the oximeter is working. It is recommended to stay quiet while using your oximeter.
6. Press the button on the front panel, if you want to change the display direction.
7. Read relevant data from the display screen.
8. The instrument has a standby mode, where no signal will be shown.
9. Please replace the batteries with new ones when the OLED indicates that the batteries are low in power.
10. When plugging your finger into the oximeter, your nail surface must show upward.
    Declaration: Please use medical alcohol to clean the rubber before each test and clean the tested finger with alcohol before and after the test. (The rubber inside of the oximeter is a medical rubber, which has no toxin, no harm, and provokes no side effects such as allergies to the skin).

Brief Description of Front Panel FEATURES:

Description of the key function: In standby mode, the instrument can be put into operating mode by pressing the start button. If this key is pressed during operation, the display mode can be changed.
NOTE: The illustration is for reference purposes only, specific in kind prevail.

Parameter setup：
Press the Power button again (less than 1 second) to scroll down the mode you want to set up. The signal “” will move each time you press the Power button. Press the Power button more than 3 seconds to start setting up.
Move the signal “” on the “Alm Setup”, press the Power button more than 3 seconds to enter the second page “Settings”, see Figure 2. The operation way is the same as Figure 1.
“Hi” means Higher , ”Lo” means Lower.

Detailed descriptions of product functions:

1. Display Type：OLED display

2. SpO2：Measurement range：70%～99%
   Accuracy：±2% on the stage of 80%～99%;
   ±3% on the stage of 70%～79%;
   Below 70% no requirement
   Resolution：±1%

3. PR：Measurement range：30BPM～240BPM
   Accuracy：±1BPM or ±1%（the largest one）

4. Power： rechargeable lithium battery

5. Power consumption：below 30mA Automatic power-off：the product shuts off by itself when no finger is in
   the product ≥8 seconds

6. Dimension：44mm×28.3mm×26.5mm

7. Operation Environment：Operation Temperature：5℃～40℃
   Storage Temperature：-10℃～40℃
   Ambient Humidity：15%～80% on operation
   10%～80% in storage
   Air Pressure： 86kPa～106kPa

8. Declaration：EMC of this product complies with IEC60601-1-2 standard.

9. Measurement Performance in Low Perfusion Condition：required test equipment (BIO-TEK INDEX Pulse Oximeter tester) can measure the available pulse wave with the amplitude of 6% of the simulation pulse wave amplitude.

10. Interference Resistance Capacity against Ambient Light:：Device works normally when BIO-TEK INDEX Pulse Oximeter tester exerts interfering signal test.

Classification

1. Class of medical device: Class II
2. Type of protection against electric shock: Internally powered equipment internal power supply
3. Degree of protection against electrical shock: Type BF

Maintenance and Preservation

1. Replace the batteries timely when the low voltage lamp blinks.
2. Clean the surface of fingertip oximeter before it is used to diagnose patients.
3. Remove the batteries inside if you will not use the oximeter for a long time.
4. It is recommended to preserve the product in -10~40ºC (14-104ºC) and a humidity of 10%-80%.
5. It is recommended to keep the product dry at any time. A wet ambience might affect its lifetime and may even damage the product. Please follow the law of the local government to deal with the disposal of used batteries.

Product Accessories

1. Lanyard for hanging the device around the neck.
2. Two “AAA” batteries.
3. User manual.

Guidance and manufacture’s declaration-electromagnetic radiation-for other EQUIPMENTS and SYSTEMS

The Pulse Oximeter is designed to be used in specified electromagnetic environment. Users of the Pulse Oximeter must use it in the following environments.

Radiation Test| Compliance| Electromagnetic environment-guidance
| | RF signal of Pulse Oximeter is simply created by
RF interference CISPR 11| Group 1| its internal function. Therefore, its RF interference is very low and is not likely to cause any interference to nearby electronic equipment
| | The Pulse Oximeter applies to all
RF interference CISPR 11| Class B| establishments,  including  domestic establishments and those directly connected to the public low-voltage power supply network
| | that supplies buildings used for domestic
| | purposes.

Possible Problems and Resolutions

• Finger is not plugged correctly.
• Patient’s Oxyhemoglobin value is too low to be measured.

|

• Retry by plugging the finger.
• Try more times. If it still doesn’t work, contact your doctor.

SpO2 or PR is shown unsteady|

• The finger might not be plugged deep enough.
• Finger is trembling, or patient is on movement status.

|

• Try again inserting your finger correctly.
• Please remain at rest.

The pulse oximeter cannot be turned on|

• Inadequate power or power off.
• The pulse oximeter might be damaged.

|

• Please charge the batteries timely.
• Please contact with local customer service Centre.

Indication lamps are suddenly off|

• The product automatically shuts off when no signal is detected in 8 seconds.
• Inadequate power.

|

• Normal.
• Please charge the batteries timely.

Symbols and Definitions

Reserves the right to technical change appearance, our products are subject to change without prior notice, please forgive me!

HOW TO REPLACE BATTERIES

1. To remove the back cover compartment, push the white button and follow the direction of the printed arrows.
2. Place two AAA batteries in the battery compartment. Match the plus (+) and minus (-) signs in the compartment. If the polarities are not matched, damage may be caused to the oximeter.
3. Slide the battery door cover horizontally along the arrow shown as the  picture.

Note:
Please remove the batteries if the pulse oximeter will not be used for long periods of time.
Please replace the battery when the power indicator starting flickering.

Installation of hanging rope

1.  Insert the thin end of the rope through the hole.
2. Insert the coarser end of the rope through the thin end part and tighten it.

Warnings!

1. Keep the oximeter away from young children. Small items such as the battery cover, battery, and lanyard are choking hazards.
2. Be wary that the lanyard does not get twisted with the device’s electrical wire.
3. Please notice that the lanyard tied to the oximeter may cause strangulation due to excessive length.

Please read instructions before use.
Xuzhou Yongkang Electronic Science Technology CO., Ltd. 1st&2nd Floor, 6#01, 6#02, No.6 Building 1st Phase Economic Development Manufacturing
Zone, LIANDO U Valley, No.6 Leye Road, Xuzhou
ETDZ, 221000 Xuzhou, PEOPLE’S REPUBLIC OF CHINA

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