AGPTEK FS20 Fingertip Pulse Oximeter User Manual

AGPTEK FS20 Fingertip Pulse Oximeter

Instructions to User

Dear users, thank you very much for purchasing the Pulse Oximeter.
This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use. Observance of this manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety.
Read this manual carefully before using the fingertip pulse oximeter.
This product is a reusable medical device. The using life is 2 years.

Safety

Contraindications

Do not use oximeter in a magnetic resonance ( MR or CT )environment.

Warnings

Keep the oximeter away from young children. Small parts such as the battery door, battery and lanyard may trigger choking hazards.

Cautions

• Do not use oximeter in the present of flammable anesthetics.
• The oximeter needs to be used according to information provided in the user manual.
• The equipment is NOT intended for neonate and infant.
• Do not use a damaged oximeter which may affect measurement performance.
• Do not place the oximeter on the same hand/arm when using a blood pressure cuff or monitor.
• Do not use the oximeter for more than 5 minutes without relocating the device to another finger.
• Do not place the oximeter on edema or fragile tissues.
• Do not use the oximeter as the only basis for making medical decision, it is intended only to be used as additional information that you can give to your licensed health care professional.
• Do not use the oximeter in high frequency environment such as electrosurgical equipment.
• Do not place the oximeter in liquid.
• Follow local disposal and recycling laws for the oximeter and its components. including the battery.
• Do not stare the light(the infrared is invisible) which emitted from the oximeter is harmful to the eyes.
• For clinical limitations and contraindications, please carefully review the medical literature
• The equipment is just a clinical diagnosis of auxiliary equipment. The physiological data displayed on the equipment are for reference only and can not be directly used for diagnostic interpretation.
• Not suitable for the users with arrhythmia/ heart failure/ Low perfusion (Pl <0.3) / finger trembling.
• Not suitable for the users with large finger size or exceeding pulse oximeter’s finger measurement cavity size.
• Please don’t use the thumb and tail finger to measure .
• Discomfort or pain may appear if using the equipment ceaselessly, especially for microcirculation barrier patients, ii recommended that the equipment should not be used on the same finger more than 5 minutes.
• The oximeter is designed to measure the percentage of arterial oxygen saturation of functional hemoglobin. Any of the following conditions may reduce the performance of the oximeter.
  ♦ Flicking or very bright light
  ♦ Moisture in the oximeter
  ♦ The individual weight less than 20kgs
  ♦ Week pulse quality(low perfusion)
  ♦ Venous pulsations
  ♦ Low hemoglobin
  ♦ Cardiogreen and other intravascular dyes
  ♦ Carboxyhemoglobin
  ♦ Methemoglobin
  ♦ Dysfunctional hemoglobin
  ♦ Artificial nails or fingernail polish
  ♦ The Finger is too cold
  ♦ Patients with abnormal circulation of finger endings caused by copd.

The Basics

The pulse oxygen saturation is the percentage of Hb02 in the total Hb in the blood, so-called the 02 concentration in the blood. It is an important bio- parameter for respiration. A number of diseases relating to respiratory system may cause the decrease of Sp02 in the blood, furthermore, some other causes such as the malfunction of human body’s self-adjustment, damages during surgery, and the injuries caused by some medical checkup would also lead to the difficulty of oxygen supply in human body. And the corresponding symptoms would appear as a consequence, such as vertigo, impotence, vomit etc. Serious symptoms might bring danger to human’s life. Therefore, prompt information of patients Sp02 is of great help for the doctor to discover the potential danger, and is of great importance in the clinical of medical field.

Principle

Principle of the oximeter is as follows: An experience formula of data process is established taking use of Lambert Beer Law according to Spectrum Absorption characteristic of Reductive hemoglobin (Hb) and oxyhemoglobin (Hb02) in glow & near-infrared zones. Operation Principle of the device is: Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning Recording Technology, So that two beams of different wavelength of lights can be focused onto human nail lip through perspective clamp finger- type sensor. Then measured signal can be obtained by a photosensitive element, information acquired through which will be shown on screen through treatment in electronic circuits and microprocessor.

Introduction

Intended Use

The Pulse Oximeter is a portable, convenient, non-invasive device, used for monitor arterial hemoglobin oxygen saturation (SP02) and pulse rate. The personal application are adult patients (weight: >30kgs) and pediatric patients(weight:20-30kgs). We recommend index finger, middle finger and ring finger are suitable position for monitor. It’s intended for spot-checking or attended-care monitoring in Home Health Care and Medical Facility.

CAUTIONS:

• This pulse oximeter is intended for use in hospital, clinical institution, healthcare community.
• The pulse oximeter is NOT designed for newborn and infant. For adults and children, it recommended that the finger thickness should between 8-25.4mm.

NOTES :

• The probe is the hole in the middle of the equipment to which the finger insert.
• The probe is the Applied part of the equipment.

Features

• The pulse oximeter is small in volumes, light in weight and easy to carry.
• One button and easy to operate.
• There are three modes: power off, sleep and measure.
• Automatically turning into sleep mode within 8 seconds after there is no signal.

NOTES:

• Press the operating button to activate oximeter(measure mode) from sleep mode.
• Power off after removing the batteries.

Front View

Functions

Function

| FS10| FS20
---|---|---
Display| LED|

OLED

Spo2 parameter measurement

| Y|

Y

Pulse rate parameter measurement

| Y|

Y

Bar graph display

| Y| Y
Battery display| Y|

Y

Automatically enters sleep mode

| Y| Y
Pulse waveform display|

_

|

Y

Symbols

Symbols|

Definition

---|---

%SpO2

|

The Pulse Oxygen Saturation( %)

PR

|

Pulse Rate(BPM)

IPX2

|

The product is protected against harmful effects of dripping waterper IEC60529.

|

Serial Number

|

The device has no Alarm System

|

Date of Manufacturer

+

|

Battery positive electrode

–

|

Battery cathode electrode

|

Caution , consult accompanying documents

|

BF type applied part

|

Manufacturer

|

This item is compliant with Medical Device Directive 93/42/EEC

|

Power indication(some models have no battery capacity indicator, but have low battery indicator)

Battery Installation

A. Put the two AAA batteries into battery compartment in correct polarities.
B. Push the battery cover horizontally along the arrow shown as figure 3.

WARNINGS:

• Battery polarities should be correctly installed, otherwise, damage may be caused to the equipment.
• Please remove the batteries if the oximeter will be stored for more than 30 days.
• Please remove the batteries if you want to turn off the oximeter. Otherwise it is always in power state.
• Battery may leak or explode if used or disposed off improperly.

Operating Guide

Application Method

A. Remove the battery cover and insert the two AAA batteries following polarity markings indicated inside of the battery compartment, then reposition the cover.
B. Hold the oximeter with the display facing toward you. slide your finger into the opening probe of the device.as shown below(Figure 4),until the fingertip touches the built-in stop guide. For best results make sure the finger is centered with in the finger guide.
C. Press the button to activate the oximeter from sleep mode, and then measurement interface will appear in 3 seconds.
D. The measurement result will be read directly from the screen.
E. The oximeter will turn into sleep mode automatically within 8 seconds after the finger left the probe.

Attention for Operation

A. Ring finger, middle finger and index finger are recommended as suitable monitor position.
B. Excessive or rapid movement may affect measurement accuracy.
C. Improper sensor placement may affect the measurement accuracy.
D. The oximeter can be reused after cleaning and disinfection.
E. The measurement comes to the best when the oximeter and the heart are at the same level.
F. (Only for FS20)The plethysmogram can be used as pulse intensity indicator. The displayed parameters might be unreliable with the disc orderly plethysmogram.
G. (Only for FS10) The bar graph can be used as pulse intensity indicator. The displayed parameters might be unreliable with un-periodic change.
H. The displayed parameters will show invalid indicator as’—‘ if signal quality is very low .
I. The displayed parameters will show invalid indicator as ‘—‘ if oximeter fault occur.
J. The maximum continuous test time does not exceed 5 minutes.

Specifications

Classification

defibrillalion proof)
Operating mode| Spot checking
Degree of protection against hazards of explosion| Ordinary equipment :Note protected
Equipment type| Fingertip oximeter

Measurement Specifications

Spo2 declared accuracy

Range (a*)| 70%-99% ± 2digits
0%-69%: unspecified
---|---
Resolution| 1 %
Update Period| 1s
Averaging Time| Bs

PR declared accuracy

Power Requirements

Environmental Specifications

Temperature

Humidity

Atmosphere Pressure

Physical Specifications

Display

 |

FS10

|

FS20

---|---|---

Display type

|

LED

|

OLED, 0.96″, 128×64 pixel

Display content

|

SpO2%,Pulse rate. Battery indicator, Bar graph

|

SpO2%, Pulse rate, Battery indicator, Bar graph, Pulse waveform, Heart beat mark

LED Wavelengths

Probe LED Specifications

 |

Wavelength

|

Radiant Power

---|---|---

RED

|

660±6nm

|

1.8mW

IR

|

905±10nm

|

2.0mW

Technical Description

The below table shows statistic conclusion of an invasive controlled desaturation study which guided by” ISO 80601-2-61,Annex EE, Guideline for evaluating and documenting SpO2 Accuracy in human subjects” .The statistic result displayed the accuracy distribution between the range of 70%-100%,which may helpful to user.

SpO2-FS10/20
Pulse Oximeter| Bias Analysis| SaO2-Radiometer ABL800 FLEX-CO-Oximeter
---|---|---
70-80(%)| 80-90(%)| 90-100(%)| 70-100(%)
Mean Bias(Bs)| 1.94| 1.45| 0.89| 1.4
Precision(Sres)| 2| 1.55| 0.98| 1.53
Accuracy(Arms)| 1.98| 1.53| 0.96| 1.52

The below is the Bland-Altman graphical plot of samples from invasive controlled desaturation study.

Maintenance, cleaning, Disinfection

Maintenance

The equipment’s design life expectancy is about 2 years, keep your equipment and accessories free of dust and dirt, and follow these rules:

A. Please clean the equipment before use according to chapter 6.2; Remove the batteries inside the battery cassette if the equipment will not be operated for a long time;
B. Replace the batteries in time when the battery voltage indicate lamps were empty;
C. It is recommended that the equipment should be kept in a dry environment with no corrosive gases and good ventilation anytime. The moisture and high-light environments will affect its lifetime and even might damage the equipment.
D. It is best to preserve the product in a place where the temperature is between -20 to 60°C and the relative humidity is less than 95%.
E. The packed equipment can be transported by ordinary conveyance. The equipment can not be transported mixed with toxic, harmful, corrosive materials.

WARING:

No modification of this equipment is allowed.

Disposal

Dispose of the pulse oximeter in accordance with local environment and waste disposal laws and regulations.

Cleaning/Disinfection

CAUTIONS:

• Never immerse or soak the oximeter.
• We recommend that the oximeter be cleaned and disinfected after use every lime or determined by your hospital’s policy, to avoid long term damage to the oximeter.
• Never use cleaning agents/disinfectants other than the recommended.
• The sensor component is not cleaned and disinfected during testing.

Cleaning

The recommended cleaning agents include: water
A. Shut down the pulse oximeter and remove the battery.
B. Clean the oximeter with cotton or soft cloth moistened with water.
C. After cleaning, wipe off the water with a soft cloth .
D. Allow the oximeter to air dry.

Disinfection

The recommended disinfectants include: ethanol 70%,isopropanol 70%.
A. Shut down the pulse oximeter and remove the battery.
B. Clean the oximeter as instructed above.
C. Disinfect the oximeter with cotton or soft cloth moistened with one of the recommended disinfectants.
D. After disinfection, be sure to wipe off the disinfectant left on the oximeter with a soft cloth moistened with water.
E. Allow the oximeter to air dry.

Accessories

• One lanyard
• Two AAA batteries
• One user manual
• One certificate card

Troubleshooting

WARNINGS:

• Necessary maintenance must be performed by qualified service personal ONLY.
• Users are NOT permitted to maintain the equipment by themselves.
• There are NO replaceable components in the equipment.

The Spo2 and PR are not displayed normally The finger is not properly positioned

exhausted An incorrect battery installation

The oximeter breakdown

| Please replace batteries

Verify and correct the batteries installation Please contact local service

The display is off suddenly| The device will turn into sleep mode automatically if there is no signal in 8 seconds| Press the button again to reactivate the oximeter
The batteries are completely exhausted| Replace batteries
The Spo2 and Pulse Rate display unstable| The luminescent or photoelectric window is sheltered by some object| Check the luminescent and photoelectric window
Excessive movement| Stop moving finger, hand and body
The finger is not placed inside deep enough| Place the finger properly and try again.
Finger size is not within the recommended range| Change another finger
Excessive ambient light| Avoid the excessive light
Pulse rate value of the cyclical fluctuations| The measurement is normal and the patient is arrhythmia.
Place the finger properly and try again.
The patient’s SpO2 is too low lo be detected| Try again, GO to a hospital for a diagnosis if you are sure the device works all right

Appendix A

The equipment complies with the requirement of standard EN60601-1-2 “Electromagnetic Compatibility-Medical Electrical Equipment”.

Guidance and manufacturer’s declaration – electromagnetic immunity

The FS10/FS20 Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of the FS10/FS20 Pulse Oximeter should ensure 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| ± 8kV contact
± BkV +15kV air| ± 8kV contact
± BkV ±15k v air| Floors should be wood, concrete or ceramic tile. If . floor re covered with synthetic material the relative hum1d1ty should be at least 30%
Power frequency (50/60Hz) magnetic field| 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.
The FS10/FS20 Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of the FS10/FS20 Pulse Oximeter should ensure that it is used in such an environment.
Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment-guidance
Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment-guidance
Conducted RF IEC 61000-4-6| 3Vrms
150 kHz to 80 MHz| 3Vrms
150 kHz to 80 MHz| Portable and mobile RF communications equipment should be used no closer to any part of the FS10/FS20 Pulse Oximeter, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Radiated RF IEC 61000-4-3| 10 Vim
80 MHz to 2,7GHz| 10V/m| 80MHz to 800 MHz
 800MHz to 2.7 GHz
 |  |  | 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). Field strengths from fixed RF transmitters, as determined by an electromagnetic.

NOTE 1 Al 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.

Guidance and manufacturer’s declaration – electromagnetic emissions

The FS10/FS20 Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of the FS10/FS20 Pulse Oximeter should ensure that it is used in such an environment.

Emissions test

| Compliance| Electromagnetic environment – guidance

RF emissions CISPR 11

| Group 1|

The FS10/FS20 Pulse 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 FS10/FS20 Pulse Oximeter is suitable for use in all establishments, CISPR 11 including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions
I EC 61000-3-2

| N/A
Voltage fluctuations flicker emissions
IEC 61000-3-3|

N/A

Applicable models

FS1 0C,FS20C
Notes:

1. The illustrations used in this manual may differ slightly from the appearance of the actual product.
2. The specifications are subject to change without prior notice.

Hunan Accurate Bio-Medical Technology Co., Ltd.
ADD: 6th,Floor,Biyang Industrial Zone, Lijiacun Road,Xueshi Street of Yuelu District,410208 Changsha Hunan Province PEOPLE’S REPUBLIC OF CHINA
Website: www.accbiomed.com
TEL/FAX: +86 -731-84118539

EC REPRESENTATIVE
Shanghai International Holding Corp. GmbH (Europe)
Add: Eiffestrasse 80. 20537 Hamburg, Germany
Tel: +49-40-2513175
Fax: +49-40-255726

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