LPOW A340 Fingertip Pulse Oximeter Instruction Manual

LPOW A340 Fingertip Pulse Oximeter

Operation quick guide

This device is intended for noninvasive spot-checking your blood oxygen saturation levels and pulse rate.

1. Install two AAA batteries into the battery compartment according to the indicated polarity + /-.
2. Insert one of your finger into the finger chamber. Finger hould also be inserted completely into the chamber.
3. Turn the device on by pressing the Power button.
4.  Read the Oxygen
   Saturation Level and Pulse Rate from the OLED Screen after a few seconds.
   The device will automatically shut down for longer than 16 seconds after finger is removed from the chamber.

• Please refer to the manual for detailed operation of the Display Switching & Parameter Setting.

Section 1

Safety

Instructions for the Safe Operation and Use of the Fingertip Pulse Oximeter

• Do not attempt to service the Fingertip Pulse Oximeter. Only qualified service personnel should attempt any needed internal servicing.
• Prolonged use or the user’s condition may require changing the sensor site periodically. Change sensor site and check skin integrity, circulatory status and correct alignment at least every 2 hours.
• SpO2 measurements may be adversely affected in the presence of high ambient light. Shield the sensor area （with a surgical towel, or direct sunlight, for example) if necessary.
• The following reason will cause interference to the testing accuracy of the Fingertip Pulse Oximeter.
  • High-frequency electrosurgical equipment.
  • Placement of a sensor on an extremity with a blood pressure cuff arterial catheter, or intravascular line
  • The user has hypotension severe vasocon-striction severe anemia or hypothermia.
  • The user is in cardiac arrest or is in shock.
  • Fingernail polish or false fingernails may cause inaccurate SpO2 readings.

Warnings

• XPLOSION HAZARD — Do not use the Fingertip Pulse Oximeter in a flammable atmosphere where concentrations of flammable anesthetics or other
• Do not throw batteries in fire as this may causes them to explode.
• Do not attempt to recharge normal dry-cell batteries, they may leak. And may cause a fire or even explode.
• Do not use the Fingertip Pulse Oximeter in an MRI or CT environment.
• Do not modify this equipment without authorization of the manufacturer.
• If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of equipment.

CAUTION

• Keep the operating environment free of dust, vibrations, corrosive, or flammable materials, and extremes of temperature and humidity.
• Do not operate the unit if it is damp or wet because of condensation or spills. Avoid using the equipment immediately after moving it from a cold environment to a warm, humid location.
• Never use sharp or pointed objects to operate the front-panel switches.
• he batteries must be taken out from the battery compartment if the device will not be used for a long time.
• The device shall only be used if the battery cover is closed.
• The batteries must be proper disposed according to local regulation after their use.
• The device should keep away from the children, pets and pests to avoid swallowing.

Definitions and Symbols

Batch code, Date of manufacturer and Serial No are printed on the label on the battery cover.

Section 2

Introduction

General

This chapter provides a general description of the Fingertip Pulse Oximeter including:

• Brief device description
• Product features

Indication for use/ intended use

The Pulse Oximeter is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for sport and aviation use, not in clinical institution.

Brief Device Description

The Fingertip Pulse Oximeter, based on all digital technology, is intended for noninvasive spot-check measurement of functional oxygen saturation of arterial hemoglobin (SpO2). Advanced DSP algorithm can minimize the influence of motion artifact and improve measurement accuracy of low perfusion. The Oximeter can be used to measure human Hemoglobin Saturation and heart rate through finger. The product is suitable for family, sport, aviation and etc.

Product Features

• Lightweight for carrying and Easy-To-Use.
• Color OLED display, simultaneous display for testing value and plethysmogram*.
• Low Perfusion : 0.3%. (Advanced DSP algorithm can improve measurement accuracy, under the condition of low perfusion.)
• Visual & Sound reminder function. Real-time spot-checks.
• Low Battery voltage indicator.
• Automatically switch off.
• Standard two AAA 1.5V Alkaline Bаttеrу support more than 20 hours continuous work.

CAUTION

• The device can not be used to measure the child below 3 years as the test result is not guarantee to accurate.
• The fingertip pulse oximeter is intended only as an adjunct in user assessment. It must be used in conjunction with other methods of assessing clinical signs and symptoms.
• A function tester cannot be used to assess the accuracy of a Fingertip Pulse Oximeter monitor or sensor. Clinical testing is used to establish the SpO2 accuracy. The measured arterial hemoglobin saturation value (SpO2) of the sensor is compared to arterial hemoglobin oxygen(SaO2) value, determined from blood samples with a laboratory CO-oximeter. The accuracy of the sensors in comparison to the CO-oximeter samples measured over the SpO2 range of 70 -100%. Accuracy data is calculated using the root-mean-square(Arms value) for all subjects. Only about two-thirds of FINGERTIP PULSE OXIMETER EQUIPMENT measurements can be expected to fall within ±Arms of the value measured by a CO-Oximeter.
• Pulse simulator shall be used to assess Pulse rate Accuracy. The measured pulse rate is compared to the preset pulse rate value in simulator. Accuracy data is calculated using the root-mean-square (Arms value) for all subjects.
• DSP algorithm: Digital signal processor algorithm.
• Low Perfusion: In physiology, perfusion is the process of a body delivering blood to a capillary bed in its biological tissue. Under the condition of low perfusion, the measurement of non-invasive saturation of pulse-blood oxygen is low-accurate.
• Plethysmograph: is an instrument for measuring changes in volume within an organ or whole body (usually resulting from fluctuations in the amount of blood or air it contains).

PI （Perfusion Index ）is the ratio of the pulsatile blood flow to the non- pulsatile static blood flow in a body’s peripheral tissue, such as finger tip, toe, or ear lobe. Perfusion index is an indication of the pulse strength at the sensor site.

Section 3

Installation,Setup,and Operation

Description of the Front Panel

Part Definition and Description

Display

After switch on, the OLED display of the Fingertip Pulse Oximeter is as follows:

Parameter setting

When the device is under measuring interface, press the select button for 1 second in order to enter into menu page (figure 3.3.1 and figure 3.3.2 ). There are two submenus for choice:

Remind Setup

Press the select button for 1 second and enter into the Remind Setup menu. User can adjust the setting through moving the “*” symbol to the back of the Sound Reminder, Beep, Restore or Brightness.

• Sound Reminder
  Press the select button to move the “*” symbol to the back of Sound Reminder, long press the select button to turn it on/off.
  (Note: If the measured value exceeds the maximum or minimum value of SPO2 or PR, there will give off sound when sound reminder is turned on.)

• Beep
  Press the select button to move the “*” symbol to the back of Beep, long press the select button to turn it on/off.
  (Note: When Beep is turned on, the sound emitted during the test indicates the pulse rate sound)

• Restore
  When the “*” symbol show behind “Restore”, long press the select button can be changed to “OK”, which causes the device to restore factory data setting.

• Demo
  Press the select button to move the “*” symbol to the back of Demo, long press the select button to turn it on/off.

• Brightness
  When the “*” symbol show on “Brightness”, long press the select button to change the Brightness value from 1 to 5.

Limit Value Setting
When the symbol show on the Reminder Setup, long press the select button until enter into the Remind Limit setup menu (figure 3.3.2). User can press the select button to select the items. And press the select button for 1 second to change the data you need.
On the Reminder Limit setup menu page (figure 3.3.2), when the symbol show behind the “+/-”. Press select button for 1 second to change the “+” to “-” or change the “-” to “+”.
When “+” shows on the right side, move the “” after the Spo2 Hi or PR Hi setting and long press the select button for 1 second can increase the value to a higher value (until it reaches to the highest.)
When “-” shows on the right side, move the “” after the Spo2 Lo or PR Lo value setting and long press the select button for 1second can reduce the value to a lower value (untill it reaches to the lowest).

Note:

1. The sound reminder have 1 second delay after the incorrect result being detected.
2. The customer can preset the limit value to the 98 or 99 to check whether it is normal for sound reminder setting.

Operation

Install battery

Installing two AAA batteries into battery cassette in correct polarities and cover it.

WARNING : Do not attempt to recharge normal alkaline batteries, they may leak and may cause a fire or even explode.

Turn the Fingertip Pulse Oximeter on Put one of fingers into rubber hole of the Oximeter (it is best to put the finger thoroughly) with nail surface upward, then releasing the clamp.
Press power button to turn the Fingertip Pulse Oximeter on.Read correspondent data from display screen.
Display Description
of OLED  It is shown as below:

Note:

1.  when battery power is at lowest level, the battery capacity indicates symbol of “ ”in OLED, remind users of replacement of battery.
2. The plethymogram can been regarded as correct if the wave is fluctuated regularly.

Section 4

Cleaning and Disinfection

Cleaning

Switch off the power and take out the batteries before cleaning, Keep the exterior surface of the device clean and free of dust and dirt. Cleaning exterior surface (OLED display screen included) of the unit with a dry and soft cloth. Use 75% density of medical alcohol to clean the surface and use dry fabric with little alcohol to avoid alcohol permeates into the device.

Disinfection

Disinfecting the machine after using by mutiple users.
Use 75% density of medical alcohol to clean the surface that contacting with the users.

CAUTION

• Don’t use strong solvent. For example, acetone.
• Never use an abrasive such as steel wool or metal polish.
• Do not allow any liquid into the product, and do not immerse any parts of the device into any liquids.
• Avoid pouring liquids on the device while cleaning.
• Don’t remain any cleaning solution on the surface of the device.

Section 5

Troubleshooting and Maintenance

Maintenance

• Replace the batteries timely when battery indication is low. Clean surface of thе Pulse Oximeter before it is used in diagnosis for user.
• Remove the batteries inside the battery cassette if the Oximeter will not be operated for a long time.
• It is better to preserve the product in a place where ambient temperature is –25°C to 55°C (-13℉-131℉) and humidity is 15%-93%.
• Regular inspection to make sure that no obvious damage existed to affect the safety and performance of device.
• No flammable substance, overtop or lower temperature and humidity existed in operation conditions.

Troubleshooting

plugged correctly.

2. User’s perfusion is too low to be measured.

| 1. Retry by plugging the finger

2. Try some more times, if you can make sure about no problem existing in the product, Please go to a hospital timely for exact diagnosis

Oxyhemo- globin or heart rate is shown unstably| 1. Finger might not be plugged deep enough

2. Finger is trembling or user’s body is in movement status

| 1. Retry by plugging the finger

2. Try not to move, let the user keep calm

Oxyhemo- globin or heart rate is abnormal and cause sound reminder| 1. Finger is not plugged correctly.

2. User’s SPO2&PR is abnormal.

| 1. Retry by plugging the finger

2. go to the hospital for further examination

The oximeter can not be powered on| 1. Power of batteries might be inadequate or not be there at all 2.Batteries might be installed incorrectly 3.The Oximeter might be damaged| 1.Please replace batteries 2.Please reinstall the batteries

3.Please contact with local customer service center

The screen are suddenly off| 1.The product is automa- tically powered off when no signal is detected longer than 16 seconds 2.Power quantity of the batteries is exhausted| 1.Normal

2.Replace the batteries

Section 6

Specification

Fingertip Pulse Oximeter Specifications: Physical Characteristics
Machine :
Dimensions :
62 mm (L) x 34mm (W) x 31mm (D)
Weight approx: 50g
（including 2 x AAA battery）
Classification ：
Anti-electric Shock Type：
Internally powered equipment
Anti-electric Shock Degree： Type BF equipment
EMC： Type B
Mode of operation: Continuous Operation Enclosure Degree of ingress protection: IP22
IP22 means shell of this product can withstand the water dropping to the surface when the shell deviate 15 degree from horizontal surface.

Power

Manufacturer’s Declaration of the EMC

Guidance and manufacturer´s declaration – electromagnetic emission –for all EQUIPMENT AND SYSTEMS

2

| The Pulse Oximeter is intended for use in the electromagnetic environment specified below.

The customer or the user of the Pulse Oximeter should assure that it is used in such an environment.

3| Emissions test| Compliance| Electromagnetic environment – guidance

4

| RF emissions

CISPR 11

|

Group 1

| The Pulse Oximeteruses 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.

5

| RF emissions

CISPR 11

|

Class B

|

The Pulse 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.

6| Harmonic emissions IEC 61000-3-2| N/A

7

| Voltage fluctuations /

flicker emissions IEC 61000-3-3

|

N/A

Guidance and manufacturer’s declaration – electromagnetic immunity –for all EQUIPMENT and SYSTEMS
Guidance and manufacturer´s declaration – electromagnetic immunity

The Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of the Pulse Oximetershould assure that it is used in such an environment.

Immunity test| IEC 60601

test level

| Compliance level| Electromagnetic environment guidance
---|---|---|---
Electrostatic discharge (ESD)

IEC 61000-4-2

| ± 8 kV contact

± 15 kV air

| ± 8 kV contact

± 15 kV air

| Floors should be wood, concrete orceramic tile. If floors are covered withsynthetic material, the relative humidityshould be at least 30 %.
Electrostatic| ± 2 kV for power|  |
transient / burst

IEC 61000-4-4

| supply lines

± 1 kV for input/ outputlines

| N/A| Mains power quality should be that of a typical commercial or hospital environment.
Surge

IEC 61000-4-5

| ± 1 kV differential mode

± 2 kV common

mode

|

N/A

|

Mains power quality should be that of a typical commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

| 0 % UT; 0,5 cycle g)

At 0°, 45°, 90°,

135°, 180°, 225°,

270° and 315°

0 % UT; 1 cycle and 70 % UT; 25/30 cycles at 0° 0 % UT; 250/300

cyclee

|

N/A

|

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Pulse Oximeter requires continued operation during power mains interruptions, it is recommended that the Pulse Oximeter

be powered from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz)

magnetic field

IEC 61000-4-8

|

30A/m

|

30A/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.

Guidance and manufacturer´s declaration – electromagnetic immunity –for EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING

Guidance and manufacturer´s declaration – electromagnetic immunity

The Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of the Pulse Oximeter should assure that it is used in such an environment.
Immunity test| IEC 60601

test level

| Compliance level| Electromagnetic environment – guidance
Conducted RF| 3 Vrms| N/A| Portable and mobile RF communications equipment should be used no closer to any part of the Pulse Oximeter, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

d = [ 3. 5] P d = [ 3. 5] P 80 MHz to 800 MHz

V 1                            E 1

d = [ 7 ] P 800 MHz to 2.5 GHz

E 1

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 metres (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 following symbol:

IEC 61000-4-6| 150 kHz to

80 MHz

|
Radiated RF| 6Vrms in ISM banda between 150 kHz to

80 MHz

|

10 V/m

IEC 61000-4-3| 80 MHz to

2.7 GHz

|

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic is affected by absorption and reflection from structures, objects and people.

a 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, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Pulse Oximeter is used exceeds the applicable RF compliance level above, the Pulse Oximeter should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Pulse Oximeter.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.

Recommended separation distances between portable and mobile
RF communications equipment and the EQUIPMENT or SYSTEM -for EQUIPMENT and SYSTEMS that are not
LIFE-SUPPORTING

Recommended separation distances between portable and mobile RF communications equipment and the Pulse Oximeter

The Pulse Oximeter is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Pulse Oximeter can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Pulse Oximeter as recommended below, according to the maximum output power of the communications equipment

Rated maximum output of transmitter W| Separation distance according to frequency of transmitter / m
---|---
150 kHz to

80 MHz

d = [ 3.5 ] P V 1

| 80 MHz to

800 MHz

d = [ 3.5 ] P E 1

| 800 MHz

to 2.7 GHz

d = [ 7 ] P E 1

0.01| /| 0.12| 0.23
0.1| /| 0.38| 0.73
1| /| 1.2| 2.3
10| /| 3.8| 7.3
100| /| 12| 23
For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres (m) can be estimated 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.

Shenzhen Aeon Technology Co., Ltd. RM6H02, Block 27-29 Tianxia IC Industrial Park, Majialong No.133 of Yiyuan road, Nantou Street Nanshan District, Shenzhen, China.
Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, 20537 Hamburg, Germany

Service contact:

www.LPOW.com
cs@LPOW.com

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