LIVIN FO0920A Med Fingertip Pulse Oximeter

LIVIN FO0920A Med Fingertip Pulse Oximeter

Dear Customer,
Thank you for choosing the LIVIN Med Fingertip Pulse Oximeter. Please read this Manual carefully before use. Failure to follow these instructions may cause inaccurate measurement or damage to the device.
This Manual is published in English, and we have the ultimate right to explain it. No part of this Manual may be photocopied, reproduced, or translated into another language without written consent from us. We reserve the right to amend it at any time without prior notice.

Notes

• The contents contained in this Manual are subject to change without notice.
• Information furnished by our company is believed to be accurate and reliable. However, no responsibility is assumed by us for its use or any infringement of patents or other rights of third parties that may result from its use.

Instructions for Safe Operation

• Check the device to make sure that there is no visible damage that may affect user’s safety or measurement performance with regard to sensors and clips. It is recommended that the device be inspected before each use. If there is obvious damage, please stop using this device.
• Special attention shall be paid when the device is used at an ambient temperature above 98.6°F/37°C as burns may occur due to over-heating of the sensor.
• Necessary maintenance must be performed only by qualified service technicians.
• The oximeter shall not be used with devices and accessories not specified in this Manual.

Cautions

• Explosive hazard—DO NOT use the Oximeter in environment with inflammable gas such as some ignitable anesthetic agents.
• DO NOT use the Oximeter while the patient is under MRI or CT scanning. This device is NOT MRI Compatible.

Warnings

• Discomfort or pain may appear if using the Oximeter continuously on the same location for a long time, especially for patient with poor microcirculation. It is recommended that the Oximeter should not be applied to the same location for longer than 2 hours. If any abnormal condition is found, please change the position of Oximeter.
• DO NOT clip this device on edema or tender tissue.
• The light (the infrared light is invisible) emitted from the device is harmful to the eyes. Do not stare at the light.
• The Oximeter is not a treatment device.
• Local laws and Regulations must be followed when disposing of the device.

Attention

• Keep the Oximeter away from dust, vibration, corrosive substances, explosive materials, high temperature, and moisture.
• The device should be kept out of the reach of children.
• If the Oximeter gets wet, please stop using it and do not resume operation until it is dry and checked for correct operation. When it is carried from a cold environment to a warm and humid environment, please do not use it immediately. Allow at least 15 minutes for Oximeter to reach ambient temperature.
• DO NOT operate the button on the front panel with sharp materials or sharp point.
• DO NOT use high temperature or high pressure steam disinfection on the Oximeter. Refer to Chapter 6 for instructions regarding cleaning and disinfection.
• The equipment is IP22 with protection against harmful solid foreign objects and ingress of liquid, which means that the equipment is protected against solid foreign objects of 12.5mm and greater and against vertically falling water drops when enclosure tilted up to 15°.
• Please pay attention to the effects of lint, dust, light (including sunlight), etc.

Declaration of Conformity

The manufacturer hereby declares that this device complies with the following standards:
IEC 60601-1: 2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance;
BS/EN/ISO 9919: 2009 or the equivalent;
ISO 80601-2-61: 2017 Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.
And it also follows the provisions of the council directive MDD 93/42/EEC.

Overview

Appearance

Front View

Rear View

Name and Model

• Name: LIVIN Med Fingertip Pulse Oximeter
• Model: FO0920A

Intended Use

This Fingertip Pulse Oximeter is for Over-the-Counter (“OTC”) purchase and is intended for measuring SpO2 and pulse rate of adult and pediatric users through his/her finger.
This oximeter is for sports or aviation use only and not for medical use.

Features and Configuration

Function Description

• Indication Sound Mute
  With the over-limits indication function and pulse beep function, when beep is on and over-limits indication sound is activated, the Display Key will work as the Mute key, and a short-time press will mute the over-limits indication sound and pulse beep for 90 seconds.

• Measuring Mode

  • Spot Check Mode: measurement starts automatically when finger is inserted into the finger clip properly, and the measuring time lasts 30 seconds with a counting-down indication. The SpO2 and PR readings will freeze at the end of the 30 seconds, and the analysis for the pulse rhythm will be displayed on the screen as well. Once the finger is out, the display will turn off, and the device will turn off automatically.
  • Continuous Mode: measurement starts automatically when finger is inserted into the device, and SpO2 and PR readings will be displayed until the finger is removed from the device. Once the finger is out, the device will turn off automatically.

• Record List

  • A single group of stable readings will be recorded in the record list each time before the device turns off under both the spot-check and continuous mode. However, if the time from displaying valid readings to the end of measurement is less than 5 seconds, then no recording will be done.
  • Up to 12 groups of records can be stored in the record list, with the newest record marked as M1 and the oldest record marked as M12. New record will override previous record.
  • When batteries are removed from the device, all readings will be deleted.
  • When the device is off, long-press the Display Key will bring up the record recall screen. On the record recall screen, short-pressing the Display Key will shift the records display. If there is no key operation for 6 seconds, the device will power off automatically again.

Battery Installation

• Install Batteries
  As shown in Figure 3, please insert 2 AAA-size batteries into the battery compartment properly and note the polarity markings.
  Please make sure that the batteries are correctly installed. Incorrect installation may cause the device not to work.

• Replace Batteries
  Please remove batteries if the device is not being used for more than 90 days to prevent and avoid potential damage from battery leaking. Any such damage is not covered under the product warranty.

Operation

• As shown in Figure 4, open the clip, put finger inside the rubber cushions of the clip (make sure the finger is in the correct position), and clip the finger.

• Next enter into data display screen:

  • Short-pressing of the Display Key will change display direction: the four display directions are as shown in Figure 5A, 5B, 5C, and 5D. For display screens of Figure 5B and 5D, the PI% display value will be replaced with PR display value after 20 seconds if no key operation is made.

• The display direction is remembered at each startup, which means it will display the same screen layout (display direction) as was set up during last use.

• At the end of Spot Check Mode, the measured SpO2, PR value, and the analysis result of pulse rhythm will be displayed on the screen, as shown in Figure 5E.

  • For other result descriptions, please see Appendix I.

• Recording and Recall Functions
  When the device is off, long-press the Display Key to bring up record list display screen, as shown in Figure 6. In the record list screen, short-press the Display key to shift the records page.

• Settings Menu
  When finger is in, long-press the Display Key will enter the settings menu screen as shown in Figure 7.

“Beep”: Pulse beep option. If it is set to On, then every pulse beat makes a beep.
“Mode”: Measuring mode setting. You may choose either “Continuous” or “Spot Check”, and the default is set to be “Spot Check”.
Short-press the Display Key to choose the setting item; long-press the Display Key to active the setting item, then short-press it to modify the setting parameter. Long-press “Exit” to store the modification and exit from the settings menu.

• Measuring Tips
  1. Please insert your finger into the finger clip correctly.
  2. Do not move your finger during measurement.
  3. Do not put wet finger directly into the clip.
  4. Avoid placing the device on the same limb which is wrapped with a cuff for blood pressure measurement or during venous infusion.
  5. Do not let anything block the emitting light from device, e.g., nail polish will affect the accuracy of measurement.
  6. Vigorous exercise and electrosurgical device interference may affect the accuracy of measurement.
  7. Long fingernail may cause failure of measurement or inaccurate result.
  8. The orientation-sensor works on the basis of gravity. A small movable metal ball is built in the orientation-sensor for detecting the orientation of the device. When you want to change the display direction, if you move too slowly, the movable metal ball will also move slowly and not receive enough acceleration. Consequently, the response of orientation detection would be delayed. Acceleration needs to be provided to the orientation-sensor for quick sensing of the orientation change.
  9. Existence of highly intensive light sources, such as fluorescence light, ruby lamb, infrared heater or strong sunshine, may lead to inaccurate measurement. Please put an opaque cover over the device or change the measuring site if necessary.
  10. If the first reading is shown in poor waveform (irregular or not smooth), then the reading is unlikely true. A more stable value might be obtained by waiting for a while, or a restart is needed when necessary.

Technical Specifications

1. SpO2 Measurement
   Transducer: dual-wavelength LED sensor with wavelength:
   Red light: 663 nm; infrared light: 890 nm
   Maximal Average Optical Output Power: ≤2mW
   SpO2 Display Range: 35%~100%
   SpO2 Measuring Accuracy:
   ≤ 2% for SpO2 range from 70% to 100%

2. Pulse Rate Measurement
   PR Display Range: 30bpm~240bpm
   PR Measuring Accuracy: ±2bpm or ±2%
   (whichever is greater)

3. Perfusion Index (PI) Display Range
   0%~20%

4. Preset Over-limits
   SpO2 Low Limit: 90%
   Pulse Rate: high limit: 120bpm
   low limit: 50bpm

5. Over-limit Settings:
   SpO2:
   Low limit setting range: 85%~99%
   (increment: 1%)
   Default setting: 90%
   Pulse Rate:
   Low limit setting range: 30~60bpm (increment: 1bpm);
   High limit setting range: 100~240bpm
   (increment: 5bpm);
   Default setting: high: 120bpm; low: 50bpm

6. Audible & Visual Alert Function
   When measuring, if SpO2 value or pulse rate value exceeds the preset limit, the device will alert with beep automatically, and the value which exceeds limit will flash on the screen.

7. Power Supply Requirement
   2 x LR03 (AAA) alkaline batteries
   Supply Voltage: 3.0V DC
   Operating Current: ≤40mA

8. Environmental Conditions:
   Operating Temperature: 41°F~104°F
   (5°C~40°C)
   Operating Humidity: 30%~80%
   Atmospheric Pressure: 70kPa~106kPa

9. Low Perfusion Performance:
   The accuracy of SpO2 and PR measurement still meets the precision described above when the modulation amplitude is as low as 0.6%.

10. Ambient Light Interference:
    The difference between the SpO2 value measured in the condition of indoor natural light and that of darkroom is less than ±1%.
    Dimensions: 2.6 in (L) × 1.4 in (W) × 1.3 in (H) / 66 mm (L) × 36 mm (W) × 33 mm (H)
    Net Weight: approx. 2.1 oz / 60 g

11. Classification
    Type of protection against electric shock: Internally powered equipment.
    Degree of protection against electric shock: Type BF applied parts.
    Degree of protection against harmful solid foreign objects and ingress of liquid: IP22 with protection against harmful solid foreign objects and ingress of liquid.
    Electro-Magnetic Compatibility: Group I, Class B.

Packing List

1. Fingertip Pulse Oximeter
2. User Manual
3. Batteries
4. Lanyard

Repair and Maintenance

Maintenance

• Please change batteries when the low-voltage indicator is on.
• Please clean the surface of the device with 75%alcohol wipes before use and let it air dry or wipe it dry. Do not allow liquid to enter the device.
• Please take out the batteries if the device is not used for a period over 90 days.
• Recommended storage environment of the device:
  • Ambient temperature: -4ºF ~140ºF (-20ºC ~60ºC)
  • Relative humidity 10%~95%
  • Atmospheric pressure: 50kPa~107.4kPa3
• The device is calibrated in the factory before sale, so there is no need to calibrate it during its life cycle. No SpO2 simulators shall be used to validate the accuracy of the device, although they can be used as functional testers to verify its precision. The SpO2 accuracy claimed in this Manual is supported by clinical study conducted by inducing hypoxia on healthy, non-smoking, light-to-dark skinned subjects in an independent research laboratory.
• If it is necessary to verify the precision of the device routinely, the user may verify by means of SpO2 simulator or by third-party test house. Please note that the specific calibration curve (so called R-curve) shall be selected when use a SpO2 simulator.
• High-pressure sterilization shall not be used on the device.
• Do not immerse the device in liquid.
• It is recommended that the device be kept in a dry environment. Humidity may reduce the life of the device or even damage it.

Cleaning and Disinfecting Instructions

• Clean the surface of sensor with a soft cloth damped with a solution such as 75% isopropyl alcohol. If low-level disinfection is required, use a mild bleach solution.
• Clean the surface with a cloth damped ONLY with clean water and dry with a clean, soft cloth.
• Do not sterilize with irradiation, steam, or ethylene oxide.
• Do not use the device if it is damaged.

Troubleshooting

1. The SpO2 and Pulse Rate displays are unstable. Solution: Place the finger correctly inside and try again.

2. The device cannot be turned on.
   Solution: Change batteries.

3. There is no display.
   Solution: Try to have the patient/user stay calm.

4. Display direction doesn’t change or changes insensitively.
   Solution: Please shake the device with a certain force to make the movable metal ball move freely. If the problem still exists, the orientation-sensor might not be working properly.

If the above problems still exist after trying the solutions, please contact our Customer Support team at support@livinwells.com.

Frequently Asked Questions

1. Q: What’s SpO2?
   A: SpO2 means the saturation percentage of oxygen in the blood.

2. Q: What’s the normal range of SpO2 value for healthy people?
   A: The normal range varies by individual but is usually over 95%. If your result is out of this range, please consult your physician.

3. Q: What’s the normal range of PR value for healthy people?
   A: Usually, the normal range is 60bpm~100bpm.

4. Q: Why do the display value of SpO2 and PR vary from time to time?
   A: The measured SpO2 and PR values change in correspondence with the change of patient’s/user’s physiological conditions.

5. Q: What to do if there is no SpO2 and PR reading?
   A: Do not move finger and keep calm during the measurement. Please also avoid using the oximeter and blood pressure monitors on the same limb at the same time.

6. Q: How to confirm that the SpO2 reading is true or accurate?
   A: Hold breath for a while (50 seconds or more), if the SpO2 value significantly decreases, it means that the SpO2 reading truly reflects the physiological condition change.

7. Q: When to replace the batteries?
   A: The icon of low battery will appear on the screen when the battery voltages are low, which means batteries need to be replaced.

8. Q: What to do if the Oximeter is moistened or sprayed by water?
   A: Remove the batteries immediately and dry the oximeter completely with a hair dryer.

9. Q: What factors will affect the SpO2 accuracy?
   A:

   • Intravascular dyes such as indocyanine green or methylene blue;
   • Exposure to excessive illumination, such as surgical lamps, bilirubin lamps, fluorescent lights, infrared heating lamps, or direct sunlight;
   • Vascular dyes or external used color-up product such as nail enamel or color skin care;
   • Excessive patient movement;
   • Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line;
   • Exposure to the chamber with high pressure oxygen;
   • There is an arterial occlusion proximal to the sensor;
   • Blood vessel contraction caused by peripheral vessel hyperkinesia or body temperature decreasing;
   • Low perfusion condition (Perfusion Index is small).

If you have further questions or concerns, please feel free to contact our Customer Support team at support@livinwells.com.

Appendix I Result Description

Appendix II EMC
The equipment meets the requirements of IEC 60601-1-2:2014.

Table 1

Guidance and Manufacturer’s Declaration- Electromagnetic Emission

This oximeter is intended for use in the electromagnetic environment specified below. The user of the oximeter shall assure that it is used in such an environment.
Emissions test| Compliance| Electromagnetic environment- guidance
RF emissions CISPR 11| Group 1| The oximeter uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11| Class B| The oximeter is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions
IEC61000- 3-2|

N/A

|
Voltage fluctuation s/flicker emissions
IEC61000- 3-3| N/A|

Table 2

Guidance and Manufacturer’s Declaration- Electromagnetic Emission

The oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of the oximeter shall assure that it is used in such an environment.
Immunity test| IEC60601 test level| Compliance level| Electromagnetic environment – guidance
Electrostatic discharge (ESD)
IEC61000-4-2| ±8 kV contact
±15kV air| ±8 kV contact
±15kV air| Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%
Electrical fast transient / burst IEC61000-4-4| ±2kV for power Supply lines ±1 kV for input/output lines| N/A| N/A
Surge

IEC 61000-4-5

| ±1kV line (s) to line(s)
±2kV line(s) to earth| N/A| N/A
Voltage dips, short interruptions and voltage variations on power supply input lines
IEC61000-4-11| <5% UT
(>95% dip in UT) for 0.5 cycle
<40% UT (60% dip in UT) for 5 cycles
<70% UT (30% dip in UT) for 25 cycles
<5% UT (>95% dip in UT) for 5 s| N/A| N/A
Power frequency (50Hz/60Hz) magnetic field
IEC61000-4-8| 3A/m| 3A/m| Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.

Table 3

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

The oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of the oximeter shall assure that it is used in such an electromagnetic environment.
Immunity test| IEC6060 1 test| Compliance level| Electromagnetic environment -guidance
| level| |
Conducted RF
IEC61000- 4-6|

3 Vrms
150 kHz to 80 MHz

| N/A| Portable and mobile RF communications equipment should be used no closer to any part of the oximeter, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

Radiated RF
IEC61000- 4-3|

3 V/m
80 MHz to 2.5 GHz

|

3 V/m

| d=1.2 P
d=1.2 P 80MHz to 800MHz
d=2.3 P 800MHz to 2.5GHz
Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). b
| | | Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range .b
Interference may occur in the vicinity of equipment marked with the symbol.
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

• Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, and electromagnetic site survey should be considered. If the measured field strength in the location in which the oximeter is used exceeds the applicable RF compliance level above, the oximeter should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the oximeter.
• Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.

Table 4

Recommended separation distances between portable and mobile RF communication the equipment

The oximeter is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the oximeter can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the oximeter as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of transmitter W (Watts)| Separation distance according to frequency of transmitter M (Meters)
150kHz to 80MHz
d=1.2 P| 80MHz to 800MHz
d=1.2 P| 80MHz to 2,5GHz
d=2.3 P
0,01| N/A| 0.12| 0.23
0,1| N/A| 0.38| 0.73
1| N/A| 1.2| 2.3
10| N/A| 3.8| 7.3
100| N/A| 12| 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

LIVIN WELLNESS, LLC
2-YEAR WARRANTY
Customer Support: support@livinwells.com

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