viatom FS20F Professional Certified Finger Pulse Oximeter User Manual

viatom FS20F Professional Certified Finger 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 user and operator safety. Read this manual carefully before using the fingertip pulse oximeter.

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 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.
•  The equipment is just a clinical diagnosis of auxiliary equipment. The physiological data displayed on the quipment 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, it 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

Principle of the oximeter is as follows: An experience formula of data process is established taking use of Lambert Beer mLaw according to Spectrum Absorption Characteristic of Reductive hemoglobin(Hb)and oxyhemoglobin(HbO2)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 mcan 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 screen through treatment in electronic circuits and microprocessors.

Introduction

The Pulse Oximeter is portable, convenient, non-invasive devices, used for monitor arterial hemoglobin oxygen saturation (SPO2) and pulse rate. The personal application are adult patients (weight: >30kg) and pediatric patients (weight: 20-30kg). We recommend index finger, middle finger and ring finger are suitable position for monitor. It’s intended for spot-checking in sports and/or aviation use. It is not for con ti nous monitoring or medical use.

CAUTIONS
The pulse oximeter is NOT designed for newborns 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
•  Press the operating button to activate oximeter (measure mode) from sleep mode.
• Power off after removing the batteries.

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.

**Front View**

Functions

• OLED Display
• Spo2 parameter measurement
• Pulse rate parameter measurement
• Bar graph display
• Battery display
• Automatically enters sleep mode
• Pulse waveform display

Symbols

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 right.

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 turn off the oximeter. Otherwise, it is always in power state.
• Battery may leak or explode if used or disposed off improperly

Operation Guide

• 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, and 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 within the finger guide.
• C. Press the button to activate the oximeter from sleep mode, and then the measurement interface will appear in 3 seconds.
• D. The measurement result will be read directly from the screen within 10 seconds;
• 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 positions.
• B, Excessive or rapid movement may affect the measurement,
• 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. The plethysmogram can be used as a pulse intensity indicator. The displayed parameters might be unreliable with the disorderly plethysmogram.
• G. The displayed parameters will show an invalid indicator as’—‘ if signal quality is very low.
• H. The displayed parameters will show invalid indicator as’—‘ if oximeter fault occur.
• I. The maximum continuous test time does not exceed 5 minutes.

Specifications

Classification

• Type of protection against electric shock: ……………………………. II (Internally powered 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: Not protected
• Equipment type …………………………………………………………………… Fingertip oximeter

Measurement Specifications

• Spo2 declared accuracy
• Range(a*) …………………………………………………………………. 70%- g9%±2digits
• 0% – 69%: unspecified
• Resolution ………………………………………………………………… 1%
• Update Period …………………………………………………………… ls
• Averaging Time …………………………………………………………. Bs
• PR declared accuracy
• Range(a*) …………………………………………………………………. 25-250: ±3digits
• Resolution ………………………………………………………………… l bpm
• Update Period …………………………………………………………… ls
• Averaging Time …………………………………………………………. Bs

Power Requirements

• Specification of batteries …………………………………………………. Two 1.5V(AAA)
• Operating voltage ………………………………………………………………. DC 2.3-3V

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%, noncondensing
  • Storage/Transportation ……………………………………………. 10-95%, noncondensing
• Atmosphere Pressure
  • Operating ……………………………………………………………….. 70-106kpa
  • Storage/Transportation ……………………………………………. 50-107.4kpa

Physical Specifications

• WidthHeightDepth ……….. … …………………………………………. About 33x36x58mm
• Weight ……………………………………………………………………………… About 60 g (including the batteries)

Display

• Display type …………………………………………………………………………………. OLED, 0.96″, 128×64 pixel
• Display content. ………………………………………………………………………….. SpO2%, PR, battery indicator, Pulse rate bar graph, pulse waveform, Hear beat mark

Technical Description

The below table shows statistic conclusion of an invasive controlled desaturation study which guided by ‘ISO80601-2- 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.

Bland-Altman Graph forSa02-Sp02

Maintenance, Cleaning, Disinfection

• The equipment design life, expectancy Is about 2 years, keep your equipment and accessory free of dust and dirt. and follow these rules:
• A. Please clean the equipment before use according to chapter 6.2; Remon the batteries Inside the battery cassette If the equipment will not be operated for a long time;
• B.8. 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 ventllatlon anytime. The moisture and high-light environments will affect its life1ime 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 P”ked equipment cen be transported by ordinary conveyance. The equipment not be transported miod with toxic, harmful, corrosive materials.

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

Cleaning  Disinfection

Cleaning

• The recommended cleaning agents include: water
• A. Shut down the pulse oximeter and remove the battery.
• It Cleans the oximeter with cotton or soft cloth moistened with water,
• C. Aftercare,and, 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 pull oximeter and remove the battery.
• B. Clean the oximeter as instructed above.
• C. Dl, infect the oximeter with cotton or soft cloth moistened with one of the recommended
• D. After disinfection, be sure to wipe off the disinfectant left on the oximeter with a soft cloth moistened with w.ater.
• E. Allow the oximeter to air dry.

Accessories

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

Troubleshooting

Appendix A

The equipment complies with the requirement of standard EN 60601-1-2: electromagnetic Compatibility•Medical Electrical Equipment

Notes:

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

References

• 艾瑞特-Accurate-Accurate

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