LyfTrack SO911 Fingertip Pulse Oximeter Instruction Manual

Model SO911
Fingertip Pulse Oximeter
Instruction Manual

Welcome to use the Fingertip Pulse Oximeter SO911.
To ensure the accuracy of measurement and safety of use, please read the manual carefully before use.

GENERAL INFORMATION

Product Information

Product Name: Pulse Oximeter
Product Model: SO911
Display Mode: LCD Display
Specifications: Finger Clip Type

Explanation of Symbols

The following symbols appear on the Pulse Oximeter and its packaging.

Accompanying
| Keep Upright| | Date of Manufacture
| Keep Dry| | Fragile. Handle with Care
| Humidity Limitations| | Temperature Limitations
| Atmospheric Pressure
Limitations|

SN

| Serial Number

IPX1

| Protective Grade| | Compliance to WEEE
Standard

Table 1: Pulse Oximeter and Packaging Symbols

SAFETY INFORMATION

Safety Standards

The manual uses the following Conventions for Notes, Cautions and Warnings.

of Noxious Liquid-Proof as IPXI Anti-Shock Degree as BF Applied Part According to the Degree of Safety of Application in the Presence of a Flammable Anesthetic Mixture with Air or with Oxygen or Nitrous Oxide, the Equipment is not suitable for use in the presence of a Flammable anesthetic mixture with air or with Oxygen or Nitrous Oxide.
Sterilization and Disinfection| As recommended by Manufacturer
Mode of Operation| Continuous

Safety Conventions

The manual uses the following conventions for Notes, Cautions and Warnings.
Note-A Note calls attention to an important point in the text.
Caution-A Caution calls attention to a condition or possible situation that could damage or destroy the product or the users work.
Warning-A Warning calls attention to a condition or possible situation that could cause injury to the user and/ or users.

Safety Requirements / Warning

• This device is intended for sport and recreational use.
• The Pulse Oximeter is not for diagnostic or therapeutic use.
• Never use the Pulse Oximeter during MRIs or CT scans.
• Never use the Pulse Oximeter in an environment of anesthetic gases.
• FUNCTIONAL TESTER cannot be used to assess ACCURACY.
• The skin temperature is initially at 35ºC for each PULSE OXIMETER, the APPLIED PART temperature cannot exceed 41ºC.
• The material that the Pulse Oximeter contacted to body is Non-toxic silica gel which meets the ISO10993 requirements, so can be safely used. But to some natural rubber latex sensitive user, there may be some allergic reactions.
• Only use accessories recommended by the manufacturer. Using other kinds of accessories might cause damage or personal injury. Modification of the Pulse Oximeter could be unsafe as applicable.
• The degrade sensor may degrade the performance.

Caution

This product is intended for use only as described in the instructions.
I. To avoid personal injury, only use accessories and parts produced or recommended by our distributors, otherwise, damage to the Pulse Oximeter may occur.
II. The Pulse Oximeter must conform to the international standard IEC6001-1-2 and other applicable EMC standards. Interference takes place when electromagnetic energy is extremely high. Ensure that any nearby instruments are also in compliance with EMC standards. Never turn on or use portable communication devices like Mobile Phones or Portable Dual Channel Radios near a Pulse Oximeter.
III. When power is lost for less than or equal to 30s, the ALARM SETTINGS prior to the power loss shall be restored automatically.
IV. Ensure that qualified service representatives annually calibrate and maintain the Pulse Oximeter.
V. Periodically check the Pulse Oximeter for damage. Dispose it according to your local hospital waste disposal regulations.
VI. Clean and sterilize the Pulse Oximeter and accessories according to local requirements. Turn off the Pulse Oximeter before cleaning or sterilization.
VII. Keep all Pulse Oximeter packing materials away from Children, Pet or Pests, or dispose of them in accordance with your local environmental regulations.
VIII. Inhalation or swallowing of small parts which might be detached from Pulse Oximeter may cause choking.
IX. Always properly dispose of the Pulse Oximeter and all accessories at the end of their service life Dispose of batteries according to your local regulations. Never incinerate battens or expose them to high temperatures.
X. Ensure that no water condenses into or on the Pulse Oximeter. condensation can occur from changes in temperature or exposure to humidity.
Warning: This device is not a complete substitute for medical treatment. It is not waterproof and shall not be used in liquids.

EMC Statement

1. Pulse Oximeter meets the requirement of electromagnetic compatibility in IEC60601-1-2.
2. The user needs to install and use it according to the electromagnetism compatibility information which is attached with it.
3. Portable and Mobile RF communication devices may influence Pulse Oximeter performance, so Pulse Oximeter should be kept away from them during usage.
4. Guidance and Manufacturer’s declaration stated in the appendix.

SCOPE OF APPLICATION

Product Operation Scope

This Pulse Oximeter is a kind of innovative detection device with non-invasive and continuous features for artery SpO2 and PR detection. It is portable and easy to measure the SpO2 and PR value quickly and precisely. This can be done through the finger Pulse Oximeter to measure Oxygen Saturation and Heart Rate.
This product is suitable for family, clinic, oxygen bar, sports health (use before and after exercise, it is not recommended to use during exercise), community health, and other areas. The suitable age group is 15 to 60 years.

General Description

Hemoglobin Saturation is the percentage of Oxyhemoglobin (HbO2) capacity compounded with oxygen, by all combination Hemoglobin (Hb) Oxygen (HbO2) capacity in the blood. In other words, it is the consistency of Oxyhemoglobin in blood. It is a very important ecological parameter for Respiratory Circulation System. Many respiratory diseases that can result in hemoglobin saturation might be reduced: such as Automatic Organic Regulation Malfunction caused by Anesthesia, Intensive Postoperative Trauma, Hurts resulting by some medical examination etc. In this situation, illness, such as light head, asthenia, vomitory etc., might happen to users and even endanger the user’s life. Therefore, it is very important to know the Hemoglobin Saturation of users timely in clinical medical aspects so that doctors can find problems in time. It is only necessary for users to put one of his fingers into a fingertip photoelectric sensor for diagnosis, and a display screen will directly show the measured value of Hemoglobin Saturation.

Measurement Principle

Principle of the Oximeter is as follows: An experience formula of data process is established taking use of Beer-Lambert law according to Spectrum Absorption Characteristics of reductive Hemoglobin (R Hb) and Oxyhemoglobin (O2Hb) in the glow and near-infrared zones. The operation principle of the instrument is photoelectric Oxyhemoglobin Inspection The technology adopted in accordance with Capacity Pulse Scanning and Recording Technology, so that two beams of different wavelengths of lights (600nm glow and 940nm near-infrared light) 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 two groups of LED through the process in electronic circuits and microprocessor.

Features

1. LCD Display, Figure and Oxygen Volume Chart Display on Interface
2. Adjust the Display Interface Direction Manually, according to the user’s observation data needs.
3. Audible Alarm Function.
4. Low Power Consumption (24 hours of continuous usage).
5. Low Perfusion ≤0.6%.
6. Low Voltage Indicator.
7. Automatic Power Off If No Signal in 8s.
8. Small and Light Weight Design, Convenient to Carry.

OPERATION

Product Operation

1. Install 2 x AAA (Triple-A) Batteries into the battery compartment with incorrect polarity as indicated and close the lid.
2. Press the Clamp, place one finger into the rubbery part with nail surface upward and release the clamp
3. Press the Switch Button to Turn On the front panel.
4. Do not shake/tremble your finger when the Oximeter is measuring, also stay still and calm, do not move your body.
5. Read correspondent date from the display screen.

Note: Please use the medical alcohol to clean the rubber touching the finger inside of Oximeter, and clean the test finger using medical alcohol before and after each test (the rubber inside of the Oximeter is medical grade rubber which has no toxin and not harmful to the human skin). Remove batteries when there is no use of it for a longer period.
Warning: The maximum application time for a PULSE OXIMETER PROBE is 4 hours continuously. The misapplication of a PULSE OXIMETER PROBE with excessive pressure for prolonged periods can induce pressure injury.

Display Description

Button Operation

1. Install 2 x AAA (Triple-A) Batteries according to the instructions, the device will turn on automatically and display Interface #1; then place your finger for measuring, if there is no finger for detection and it is without the operation, it will power off automatically in 8s.
2. When there is a battery, but the Pulse Oximeter is powered off, press the button to turn on again.
3. During the measurement (there is a measurement signal and figure), press and hold the button during the measurement, it can turn to the settings menu interface. Switch to different options by the short press, modify the option by long press.

Beep
Pulse Beep| On/Off, Default Off| On: Buzzer On
Off: Buzzer Off
SPO2 Lo| Range: 70-99, Default 94
Step Value 1%| Alm=On: The measurement of
SPO2 value will flicker under the
settings.
Alm=Off: No effect
PR Hi| Range: 50-205, Default 130
Step Value 5 BMP| Alm=On: The measurement of PR
Hi value will flicker above the
settings.
Alm=Off: No effect
PR Lo| Range: 45-200, Default 50
Step Value 5 BMP| Alm=On: The measurement of PR
Lo value will flicker above the
settings.
Alm=Off: No effect
Restore| On/Off, Default On| On: Restore the default Off: Other options changed
+/-| “+” / “-“, Default “+”| “+”: The selected options of SPO2
Lo/PR Hi/PR value will increase.
“-“: The selected options of SPO2
Lo/PR Hi/PR Lo value will
decrease.
Exit| None| Exit the settings.

Table 1: Button Operation

ALARM

Alarm

The Pulse Oximeter uses the following alarm indicators: Audible Alarm and Visual Alarms.
Note: To correctly identify visual alarms, always observe the Pulse Oximeter within 1 meter of its position.

Low Power Alarm

When battery power is at the lowest level, the battery capacity indicates empty in the LCD to remind users of the replacement of the battery cells.
Note: When power is left for less than or equal to 30s, the ALARM SETTINGS prior to the power loss shall be restored automatically.

Audible Alarm

The audible alarm is a buzzer alarm; the auditory sound pressure range is 45dB~70dB.

SpO2 and PR Alarm

• Default alarming value of PR: High Limit = 130bpm, Lower Limit = 50bpm.
• Default alarming value of SpO2: 94%.
• When it is under operation conditions if the measurement of the PR and SpO2 value exceeds the set alarm limit and the alarm switch is on, it has a sound alarm and long buzzer alarm.
• When it is under operation conditions, if the PR sound switch is on, the measurement of PR will go with a PR sound.

To test the alarm according to the following:
a) Connect the Pulse Oximeter to the simulator.
b) The simulator settings: SpO2 90%, PR 200bpm.
c) The Pulse Oximeter alarm setting: SpO2 95%, PR High Limit 130bmp.
d) Verify the Pulse Oximeter Alarm.

SPECIFICATIONS

SpO2 Specifications

The update rate for the SpO2 value and pulse rate is typically 1 second of data on an average, and other signal processing on the displayed and transmitted data values of SpO2 and pulse rate is not more than 20 seconds. Depending on the magnitude of difference between the alarm limit and the displayed value, the alarm signal generation delay maybe from 1~20 seconds. The maximum alarm condition delay is 4 seconds, the Alum alarm signal delay is 20 seconds, the average alarm condition is 2 seconds, the average alarm signal is 10 seconds.
Because Pulse Oximeter measurements are statistically distributed, only approximately two-thirds of Pulse Oximeter equipment measurements can be expected to fall within Arms value measured by Co-Oximeter.
The signal adequacy is indicated by waveform, and it is NORMALIZED.
Note: The Pulse Oximeter EQUIPMENT is calibrated to display FUNCTIONAL OXYGEN SATURATION. It is not
necessary to have a SpO2 calibration when the Pulse Oximeter is in use.
The following table describes the SpO2 specifications

Another scope is not defined
Sp02 Alarm Range| Consistent with the display range, the set step length is
1%
Pulse Rate Range| 30bpm-250bpm
Pulse Rate Accuracy| ±2bpm or ± 2% to the maximum
Pulse Rate Alarm Range| Consistent with the display range, the set step length is
Sbpm
Data Update Cycle| 0.25s-2s
Sp02 PR Average| 8s
Pulse Beep| Support
Peak Wavelength Range| 500nm-100nm
Maximum Optical Output Power| 150mW
Pulse Rate Display| Numeric
Display Specifications| LCD
Power Dissipation| In Normal Measurement, less than 25mA

Table 1: SpO2 Specifications

Power Specifications

The following table describes the power specifications

The Pulse Oximeter powers off if the battery power is
almost depleted.

Physical Specifications

The following table describes the physical specifications

Table 2: Physical Specifications

Environmental Specifications

The following table describes the environmental specifications

Storage: -10ºC~+40ºC for the device
Relative Humidity| Operating: 15%~80% (non-condensing)
Storage: Less than 95% (non-condensing)
Biometric| Operating: 86kPa~106kPa
Storage: 50kPa~106kPa

Table 3: Environmental Specifications

TROUBLESHOOTING

Repair, Maintenance & Troubleshooting

1. Regular inspection is required to make sure that no obvious damage exist to affect the safety and performance of the device.
2. Make sure that no flammable substance, overtop or lower temperature and humidity exist in the operation conditions.
3. When lower power capacity light is in red color, please replace the battery right away.
4. Please clean the surface before applying for detection.
5. Please take out the battery when device is not being used for a longer period of time.
6. If there is a dust or dirt on the surface, medical alcohol with 75% density can be used to clean the surface, please use dry fabric with little alcohol to wipe it with.
7. The transportation and storage conditions are: Temperature: 10 ºC~40 ºC, Humidity: Less than 95%.

Please use the following instructions for Troubleshooting

Instability of Sp02 and Pulse Rate
Display| Finger is not placed inside enough.
Finger is shaking or user is moving.| Place the finger properly and try again.
Let the user to keep calm.
Device cannot Power On| Batteries are drained or low power. Batteries are not inserted properly. Device is malfunctioning.
Reinstall Batteries.| Change the Batteries.
Please contact the local service center.
Indicator Light has Turned Off
Suddenly| Device powers off automatically if
there’s no signal for 8s.
The Batteries are drained or low power.| Normal.
Change the Batteries.
Sp02 and Pulse Rate Alarm| Value has exceeded the high alarm limit or it is below the low alarm limit.| Check the user’s physical status, and alarm limit setup.

Table 1: Troubleshooting

CERTIFICATE OF COMPLIANCE

Warranty & After Sales Support

1. This product is used for five years from the date of purchase; you can enjoy a one-year free warranty.
2. The packaging is not covered by the warranty.
3. For the following damage caused by the user, please forgive us for not providing free warranty service;
   a) Failure caused by unauthorized disassembly and modification.
   b) Failure caused by accidental drop during use or handling;
   c) Failure caused by not following the correct instructions in the manual;
   d) Failure caused by lack of reasonable maintenance;
   e) When requesting to provide free warranty service, you must hold the warranty card filled with the date of purchase and the seal of the purchasing dealer (including the name and address of the dealer).
   f) Repair services outside the warranty scope will be charged according to the corresponding regulations;
   g) When requesting free warranty service, please take this product to the dealers of our company for repair.

Certificate of Compliance

CERTIFICATE OF COMPLIANCE

PRODUCT NAME| FINGERTIP PULSE
OXIMETER| MODEL| SO911
DATE OF
INSPECTION| | INSPECTOR

This product has passed the inspection and is allowed to leave the factory.

Warranty Card

WARRANTY CARD

BATCH NUMBER| | PRODUCT CODE|
SELLER| | DATE OF PURCHASE|
CUSTOMER’S NAME| | CUSTOMER’S  PHONE|
CUSTOMER’S ADDRESS| | CUSTOMER’S EMAIL|
FAULT DESCRIPTION|

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