HealthSmart Pulse Oximeter Instruction Manual

HealthSmart Pulse Oximeter Instruction Manual

INSTRUCTIONS FOR:
Item # 40-815-000 (FS10 D)
Item # 40-816-000 (FS10 K)
Item # 40-817-000 (FS20 K)

PACKAGE INCLUDES

• 1 Pulse Oximeter
• 1 Lanyard
• Two (2) AAA batteries
• Instructions in English & Spanish

IMPORTANT

Thank you for purchasing this Pulse Oximeter.
This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use. Please read this manual in its entirety for proper product performance, correct operation, and to ensure patient and operator safety.

• Read this manual carefully before using the fingertip pulse oximeter.
• Product lifespan 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 be 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 or 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/tender tissues.
• Do not use the oximeter as the 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 electro-surgical 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 emitted from the oximeter is harmful to the eyes.
• Carefully review the “Troubleshooting” section of this manual if any problems are encountered during use
• 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 (PI <0.3) / finger trembling
• Not suitable for the users with large finger size or exceeding pulse oximeter’s finger measurement cavity size.
• Do not use the thumb or little finger for measurement.
• Discomfort or pain may appear if using the equipment continuously, especially for micro-circulation 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 44 Ibs. (20kgs)
  • Week pulse quality (low perfusion)
  • Venous pulsations
  • Low hemoglobin
  • Cardiogreen and other intravascular dyes
  • Carboxyhemoglobin
  • Methemoglobin
  • Dysfunctional hemoglobin
  • Artificial nails or fingernail polish
  • Cold hands or fingers
  • Patients with abnormal circulation of finger endings caused by COPD

INTRODUCTION

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.

INTENDED USE:

The pulse oximeter is a portable, convenient, non-invasive device, used to monitor arterial hemoglobin oxygen saturation (SP02) and pulse rates. This unit is designed for adult patients (weight: >60 lbs.) and pediatric patients (weight: 44 ~ 60 lbs.). We recommend using the index finger, middle finger or ring finger as the best suitable locations for measurement. THIS DEVICE IS INTENDED TO MONITOR HEART RATE AND OXYGEN SATURATION DURING EXERCISE AND NOT INTENDED FOR MEDICAL DIAGNOSIS, TREATMENT OR CONTINUOUS USE MONITORING.

CAUTION:

• The pulse oximeter is NOT designed for newborns or infants. For adults and children, we recommend the person’s finger thickness should be between 0.31″ ~ 1.0″ (8 ~25.4mm)

NOTES:

• The probe is the hole in the middle of the equipment in which the finger is inserted
• The probe is the Applied part of the equipment

FEATURES:

• The pulse oximeter is small and lightweight making it easy to carry with you anywhere.
• One button for easy operation
• Three operating modes: power off, sleep and measure.
• Automatically goes into sleep mode within 8 seconds after the finger has been removed and no signal is detected.

FUNCTIONS

SYMBOLS

BATTERY INSTALLATION

1. Slide cover off of the backside of pulse oximeter.
2. Insert two ‘AAA’ batteries into the compartment, matching the indicated polarity symbols.
3. To close, slide cover back into place.

WARNING:

• Battery polarities should be correctly installed, otherwise, it may damage the unit.
• Remove batteries if unit will be stored for more than 30 days.
• To completely turn off the unit, please remove the batteries. Otherwise the unit is always in sleep mode, but may still be using some battery power.
• Batteries may leak or explode if used or disposed of improperly

OPERATING GUIDE

1. Remove the battery cover and insert the two ‘AAA’ batteries noting the polarity markings indicated inside of the battery compartment. Replace the cover.
2. Hold the oximeter with the display facing toward you. Slide your finger into the opening probe of the device (as show below) until the fingertip touches the built-in stop guide. For best results, make sure the finger is centered within the finger guide.
3. Press the button to activate the oximeter from sleep mode. The measurement interface will appear in 3 seconds.
4. The measurement results will show on the screen.
5. The oximeter will turn back to sleep mode automatically within 8 seconds after the finger has been pulled out.

OPERATING NOTES

1. Only use your ring finger, middle finger or index finger for measurements.
2. Excessive or rapid movements may affect measurement accuracy.
3. Improper sensor placement may affect the measure accuracy.
4. The oximeter can be reused after cleaning and disinfection.
5. Be sure to keep the oximeter at the same level as your heart.
6. The display will show invalid indicator as ‘—‘ if the signal is very low.
7. The display will show invalid indicator as ‘-‘ if an oximeter error occurs.
8. Do not use the oximeter for more than 5 minutes without relocating the device to another finger.

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: Fringertip Oximeter

Power Requirements

Specification of Batteries: Two 1.5V (AAA)
Operation Voltage: DC 2.5~3V

NOTE: Product specifications are subject to change without prior notice. Illustrations used in this manual may differ slightly from the actual product. Illustrations are for reference only.

Measurement Specifications

Sp02 Declared Accuracy

Range: 70%~99% = 2 digits
Resolution: 1%
Update Period: 1 second
Averaging Time: 8 seconds

PR Declared Accuracy

Range: 25~250 ± 3 digits
Resolution: 1 bpm
Update Period: 1 second
Averaging Time: 8 Seconds

Environmental Specifications

Temperature
Operating: +41°F~104°F (5°C~40°C)
Storage: -4°F~140°F (-20°~60°C)
Humidity
Operating: 10~95%, noncondensing
Storage/Transport: 10~95%, noncondensing
Atmosphere Pressure
Operating: 70~106 kpa
Storage/Transport: 50~107.4 kpa

Physical Specifications

Width x Height x Depth: About 1.29″ x1.41″ x2.28″ (33x36x58mm)
Weight: 2.1 oz. (60 grams)

Display

LED Wavelengths

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 be helpful to the user.

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

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:

1. Please clean the equipment before use. Remove the batteries inside the battery compartment if the equipment will not be operated for a long time (30 days).
2. Replace the batteries when the low battery signal appears on screen.
3. It is recommended that the equipment should be kept in a dry environment with no corrosive gases and good ventilation. The moisture and high-light environments will affect its lifetime and might even damage the equipment.
4. It is best to store the product in a place where the temperature is between -4° to 140°F (-20°C to 60°C) and the relative humidity is less than 95%.
5. The packed equipment can be transported by ordinary conveyance. The equipment can not be transported mixed with toxic, harmful, corrosive materials.

WARNING: Do NOT make any modification to this equipment.
DISPOSAL: Please dispose of the pulse oximeter in accordance with local environment and waste disposal laws and regulations.

CLEANING & DISINFECTING

CAUTION

• Never immerse or soak the oximeter in water or other solution.
• We recommend the oximeter be cleaned after ever use.
• Never use other cleaning agents or disinfectants than what is recommended.

Cleaning

To properly clean the unit follow the steps below:

1. Turn off the pulse oximeter and remove the batteries.
2. Gently wipe unit with cotton or a soft cloth moistened with water.
3. After cleaning, wipe off excess water with a soft dry cloth.
4. Allow to air dry.

Disinfecting

To disinfect the unit, follow the cleaning steps above.

1. Then, use a soft cloth moistened with 70% ethanol or 70% isopropanol to gently clean the unit.
2. Use a soft cloth moistened with water to gently wipe clean the unit.
3. Allow the oximeter to air dry.

TROUBLESHOOTING

WARNING

• There are no replaceable or serviceable parts on the pulse oximeter.

APPENDIX

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

WARRANTY

A one year limited warranty is available from date of purchase, excluding user-caused failures listed below:

1. Failure resulted in unauthorized disassembly and modification
2. Failure resulted in unexpected drop during application or transportation
3. Failure resulted in operation away from proper instruction in user’s manual

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