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User Manual
Ver.1.0
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.
General Description
Haemoglobin Saturation is the percentage between the capacity of Oxyhemoglobin (HbO2) that compounded with oxygen and that of all combined haemoglobin (Hb) obin (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 haemoglobin saturation in human blood. Moreover, factors such as Automatic Organic Regulation Malfunction caused by anaesthesia, trauma resulted from major operation and some medical examination can also cause problems in oxygen supply, which might reduce human haemoglobin 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 for patient to put one finger into 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, and then measurement signal got via a photosensitive element. Relevant measurement information will be processed in electronic circuits and microprocessor and then showed up on the OLED display.
Diagram of Operation Principle
1. Infrared-ray receiving tube
2. Infrared-ray transmitting tube
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 blood oxygen saturation prompt function, but it is not for continuously 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 hemoglobins (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 use surgical towel against direct sunlight to protect the oximeter 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, including batteries.
Features
u OLED display
Ø Product adopts double color OLED display，can show the six different display mode
Ø Low-power consumption, continuously work for 40 hours
Ø Low voltage indicator
Ø In the absence of signals, the product will be in after 8 seconds to enter standby state
Ø Visual and auditory prompt function.
Ø Small in volume, light in weight, and convenient to carry
Product Operation Scope
The fingertip oximeter can be used to measure human haemoglobin saturation and heart rate through finger. The product applies to using in family, hospital (including clinical use in internist/surgery, anaesthesia, paediatrics, intensive care, etc.), oxygen club, social medical organizations, physical care in sports (It can be used before or after sports. Operation in sport procedure is not recommended). It is also applicable to enthusiasts on mountaineering, patients (convalescents at home or those need first aid treatment), elders over 60, those work more than 12 hours, sporters and those work in the hermetic circumstance, etc. The product is not suitable to monitor patient continuously.
Operation Instructions
1. Hold the lock button on the battery cover, push the battery cover down at the same time, the battery cover is opened.
2. Install two AAA batteries into battery cassette before covering its cover.
3. Plug one finger into rubber hole of the oximeter (it is best to plug the finger thoroughly) before releasing the clamp with the nail upwards.
4. Press button on the front panel;
5. Don’t tremble your finger when the oximeter is working. It is recommended to stay standstill while using your oximeter.
6. Press the button on the front panel, if we want change display direction;
7. Read relevant datum from display screen.
8. The instrument has the function of sleep, no signal will enter standby state of sleep;
9. Please replace new batteries when OLED indicates the batteries are in low power.
When plugging your finger into the oximeter, your nail surface must be 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 adopts medical rubber, which has no toxin, no harm, and brings no side effect such as allergy to the skin ).
Brief Description of Front Panel
Keys function description: in standby mode, start the key instrument into the working state, push down this button under working state, can change the display mode.
Parameter Setup：
Figure 1 Figure 2
1. Press the Power button more than 3 seconds to enter the “Settings” page, see Figure 1.
Press the Power button again (less than 1 second) to scroll down the mode you want to set
up. The signal "*" will move when you press the Power button each time. Press Power
button more than 3 seconds to start setting up.
2. 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 70%～99%，Unspecified(≤70%) for SPO2
Resolution：±1%
3. PR：Measurement range：30BPM～240BPM
Accuracy：±1BPM or ±1%（the larger one）
4. Power： two AAA 1.5V alkaline batteries
5. Power consumption：below 30mA
6. Standby: move finger out from instrument, the device will be in Standby mode after 15 seconds.
7. Operation Environment：Operation Temperature：5℃～40℃
Storage Temperature：-10℃～40℃
Ambient Humidity：15%～80% on operation 10%～80% in storage
Air Pressure： 70kPa～106kPa
8. Declaration：EMC of this product comply with IEC60601-1-2 standard.
9. Measurement Performance in Low Perfusion Condition：required test equipment (BIO-TEK INDEX Pulse Oximeter tester) could 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. Management Class for Medical Devices: Ⅱ equipment
2. Anti-electric Shock Type: Internally powered equipment
3. Anti-electric Shock Degree: Type BF equipment
Maintenance and Preservation
1. Replace the batteries timely when low voltage lamp is on.
2. Clean the surface of fingertip oximeter before it is used to diagnose patients.
3. Remove the batteries inside if you will not operate the oximeter for a long time.
4. It would be better to preserve the product in -10~40℃ (14-104℉) and humidity is 10%-80%.
5. It is recommended that the product should be kept dry anytime. A wet ambience might affect its lifetime and even damage the product.
6. Please follow the law of the local government to deal with used batteries.
Product Accessories
1. One lanyard
2. Twp AAA batteries
3. One user manual
Guidance and manufacture’s declaration-electromagnetic radiation-for other EQUIPMENTS and SYSTEMS
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The Pulse Oximeter is designed to be used in specified electromagnetic environment . Users of the Pulse Oximeter must use it in the following environments.
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Radiation Test
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Compliance
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Electromagnetic environment-guidance
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RF interference
CISPR 11
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Group 1
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RF signal of Pulse Oximeter is simply created by its internal function. Therefore, its RF interference is very low and is not likely to cause any interference to nearby electronic equipment.
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RF interference
CISPR 11
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Class B
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The Pulse Oximeter applies to all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
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Possible Problems and Resolutions
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Problem
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Possible reason
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Solution
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SpO2 or PR can not be shown normally
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1. Finger is not plugged correctly
2.Patient’s Oxyhemoglobin value is too low to be measured
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1. Retry by plugging the finger
2. Try more times. If you can make sure there is no problem in the product, please go to hospital timely for exact diagnosis
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SpO2 or PR is shown unsteady
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1. The finger might not be plugged deep enough
2. Finger is trembling or the patient is on movement status
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1. Retry by plugging the finger
2. Please remain at rest
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The oximeter cannot be
turned on
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1. Inadequate power or power off
2. Batteries might be installed incorrectly
3. The oximeter might be
damaged
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1. Please replace the batteries
2. Please reinstall the batteries
3. Please contact with local customer service centre
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Indication lamps are suddenly off
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1. The product automatically shuts off when no signal is detected in 8 seconds
2. Inadequate power
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1. Normal
2. Replace the batteries
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Symbols and Definitions
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Symbol
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Definition
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The equipment type is BF
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Refer to user manual before application
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﹪SpO2
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Hemoglobin Saturation
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 PR
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Heart Rate(BPM)
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Low power indication
DEEE (2002/96/CE)
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SN
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Serial No.
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How to replace batteries:
1. To remove the back cover compartment push the white button and follow the printed arrows direction
2. Install two AAA batteries into 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:
² Please remove the batteries if the pulse oximeter will not be used for long periods of time.
² Please replace the battery when the power indicator starting flickering.
Using the Lanyard
1. Thread thinner end of the lanyard through the hanging hole.
2. Thread thicker end of the lanyard through the threaded end before pulling it tightly.
Warnings!
1. Keep the oximeter away from young children. Small items such as the battery cover, battery, and lanyard are choking hazards.
2. Avoid the lanyard twisted with the device’s electrical wire.
3. Please notice that the lanyard tied to the oximeter may cause strangulation due to excessive length.