MEDIAUS 82253 FS10C ACCUR 8 Pulse Oximeter User Manual

MEDIAUS 82253 FS10C ACCUR 8 Pulse Oximeter

A Special Thank You
Thank you for choosing Accur8 Pulse Oximeter. We’re proud of the care and quality that goes into the manufacturing of each and every item that bears our name. Only the finest materials are used to assure you of a timeless instrument designed for optimum performance. This device offers clinically proven accuracy and has been designed to be user friendly. Read this booklet thoroughly before attempting to use your new Accur8 Pulse Oximeter. Thank you for your patronage. It is indeed our pleasure to serve you.

Authorised Australian & New Zealand Representative:
Sincerely, TV Innovations Ply. Ltd.
Address: 7/17 Stanton Road, Seven Hills, NSW 2147, Australia

Instructions to User
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 Accur8 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 an oximeter in the presence of flammable anesthetics.
• The oximeter needs to be used according to the information provided in the user manual.
• The equipment is NOT intended for neonates and infants.
• 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 decisions.it is intended only to be used as additional information that you can give to your licensed healthcare professional.
• Do not use the oximeter in high-frequency environments 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 at the light(the infrared is invisible) which is 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 users with arrhythmia/heart failure / Low perfusion (Pl <0.3) / finger trembling.
• Not suitable for 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, it is 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
  • Carboxyhaemoglobin
  • Methaemoglobin
  • Dysfunctional hemoglobin
  • Artificial nails or fingernail polish
  • The Finger is too cold
  • Patients with an abnormal circulation of finger endings caused by COPD.

The Basics

The pulse oxygen saturation is the percentage of HbO2 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 the respiratory system may cause the decrease of SpO2 in the blood, furthermore, some other causes such as the malfunction of the human body’s self-adjustment, damages during surgery, and injuries caused by some medical checkups 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, vomiting etc. Serious symptoms might bring danger to human life. Therefore, prompt information of patients’ SpO2 is of great help for the doctor to discover the potential danger, and is of great importance in the clinical of medical field.

Principle
The 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 (HbO2) in glow&near-infrared zones. The 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 wavelengths of lights can be focused onto a human nail tip through a 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 microprocessors.

Introduction

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

Warning:
This pulse Oximeter is intended for use only by clinical professionals or under their guidance. It must only be used by persons who have received adequate training in its use. Anyone unauthorized or untrained must not perform any operation on it.

CAUTIONS:

• This pulse oximeter is intended for use in home, hospitals, clinical institutions, and healthcare communities.
• The pulse oximeter is NOT designed for newborns and infants. For adults, it is 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 is inserted.
• The probe is the Applied part of the equipment.

Features

• The pulse oximeter is small in volume, 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 the oximeter (measure mode) from sleep mode.
• Power off after removing the batteries.

Front View

Functions

Symbols

Battery Installation

• Put the 2 AAA batteries into the battery compartment in the correct polarities.
• 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 a power state.
• The battery may leak or explode if used or disposed of improperly.

Operating Guide

Application Method

• Remove the battery cover and insert the two AAA batteries following the polarity markings indicated inside the battery compartment. then reposition the cover.
• 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.
• Press the button to activate the oximeter from sleep mode, and then the measurement interface will appear in 3 seconds.
• The measurement result will be read directly from the screen for about 10 minutes.
• The oximeter will turn into sleep mode automatically within 8 seconds after the finger left the probe.

Attention for Operation

• Ring finger, middle finger, and index finger are recommended as suitable monitor positions.
• Excessive or rapid movement may affect measurement accuracy.
• Improper sensor placement may affect measurement accuracy.
• The oximeter can be reused after cleaning and disinfection.
• The measurement comes to the best when the oximeter and the heart are at the same level.
• The bar graph can be used as a pulse intensity indicator. The displayed parameters might be unreliable with un-periodic change.
• The displayed parameters will show an invalid indicator as ‘—‘ if the signal quality is very low.
• The displayed parameters will show an invalid indicator as ‘—‘ if an oximeter fault occurs.
• The maximum continuous test time does not exceed 5 minutes.

Specifications

Classification

• Type of protection against electric shock …………………… Internally powerted equipment
• Degree of protection against electric shock …………….. Type BF-Applied part(non-defibrillation 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 …………………………………………….. 8s

PR declared accuracy

• Range(a*) ……………………………………………………. 25-250: ± 3 digits
• Resolution ……………………………………………………. 1 bpm
• Update Period ………………………………………………. 1s
• Averaging Time ……………………………………………. 8s 5.3

Power Requirements

• Specification of batteries ………………………………… Two 1.5V(AAA)
• Operatin voltage ………………………………………………… DC 2.5-3V

Environmental Specifications

Temperature

• Operating …………………………………………………….. +41° to +104° F/5° to +40″C
• Storage/Transportation: ……………………………………….. -4° to +140° F/-20 to +60″C

Humidity

• Operating …………………………………………………………. 10~95%, non-condensing
• Storage/Transportation ………………………………….. 10-95%, non-condensing

Atmosphere Pressure

• Operating …………………………………………………….. 70-106kpa
• Storage/Transportation …………………………………… 50-107 .4kpa

Physical Specifications

• Width x Height x Depth ……………………………. About 33x36x58mm
• Weight… ……………………………………………… About 60g (including the batteries)

Display

LED Wavelengths

Probe LED Specifications

Technical Description

The below table shows the stat ist ic conclusion of an invasive controlled desaturat ion study guided by” ISO 80601-2-61, Annex EE.Gu idel ine for evaluating and documenting SpO2 Accuracy in human subjects”.The stat ist ic result displayed the accuracy distribut ion between the range of 70%~100%,wh ich may be helpful to the user.

The below is the Bland-Altman graph ical plot of samples from invas ive controlled desaturation study.

Bland-Altman Graph for SaO2-Sp02

Maintenance, cleaning, Disinfection

Maintenance

Keep your equ ipment and accessor ies free of dust and dirt, and follow these rules:

• Please clean the equ pi ment before use accord ni g to chapter 6.2; Remove the batter ei s ins di e the battery cassette if the equ ipment w ill not be operated for a long t ime;
• Replace the batteries in t ime when the battery voltage ind icate lamps were empty;
• It is recommended that the equ ipment should be kept in a dry env ironment w ith no corros ive gases and good vent ilat ion anyt ime. The moisture and h igh-l ight env ironments w ill affect its l ifet ime and even m ight damage the equ ipment.
• 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%.
• 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 off 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 time 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

• Shut down the pulse oximeter and remove the battery.
• Clean the oximeter with cotton or soft cloth moistened with water.
• After cleaning, wipe off the water with a soft cloth.
• Allow the oximeter to air dry.

Disinfection
The recommended disinfectants include: ethanol 70%, isopropanol 70%.

• Shut down the pulse oximeter and remove the battery.
• Clean the oximeter as instructed above.
• Disinfect the oximeter with cotton or soft cloth moistened with one of the recommended disinfectants.
• After disinfection, be sure to wipe off the disinfectant left on the oximeter with a soft cloth moistened with water.
• Allow the oximeter to air dry.

Accessories

• One lanyard
• Two AAA batteries Included *(For best results: Alkaline Batteries Recommended)
• One user manual
• One certificate card

Note:
For particular configuration of accessories please refer to the product package list.

Troubleshooting

WARNINGS:

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

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
Trouble| Possible Reason| Solution
---|---|---
 | 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.
The Spo2 and PR are not displayed normally| The finger is not properly positioned| Place the finger properly and try again.
The patient’s SpO2 is too low to be detected| Try again.GO to a hospital for a diagnosis if you are sure the device works all right

Appendix

The equ ipment compl ies w ith the requ irement of standard EN60601-1-2 “Elecrtromagnetic Compatibility-Medical Electrical Equipment”.

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

The Accur8 Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of the Accur8 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.

±8kV, ±15kV air

| +

_8kV contact.

±8kV,±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%
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.

Notes:

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

Hunan Accurate Bio-Medical Technology Co.,Ltd.
Gth, Floor, Biyang Industrial Zone, Lijiacun Road, Xueshi Street ofYuelu District, 410208 Changsha, Hunan Province, PEOPLE’S REPUBLIC OF CHINA.

Authorised Australian & New Zealand Representative:

• Company Name: TV Innovations Ply. Ltd.
• Contact person: Sumat
• Address: 7/17 Stanton Road, Seven HIiis, NSW 2147, Australia
• E-mail: sumat@tvinnovations.com.au.

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