Accuracy Digit Fingertip Pulse Oximeter Finger Blood Oxygen

Accuracy Digit Fingertip Pulse Oximeter Finger Blood Oxygen Monitor

Section1

1. 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.

· Do not use the pulse oximeter in situations where alarms are required. The device has no alarms.

· Prolonged use or the patient’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 and defibrillators.

· High-frequency electrosurgical.

· Placement of a sensor on an extremity with a blood pressure cuff arterial catheter, or intravascular line.

· The patient has hypotension severe vasoconstriction severe anemia or hypothermia.

· The patient is in cardiac arrest or is in shock.

· Fingernail polish or false fingernails may cause inaccurate SpO2 readings.

1.2 Warnings

WARNING: EXPLOSION HAZARD—Do not use the Oximeter in a flammable atmosphere where concentrations of flammable anesthetics or other material may occur.

WARNING: Do not throw batteries in fire as this may causes them to explode.

WARNING: Do not attempt to recharge normal dry-cell batteries, they may leak, And may cause a fire or even explode.

WARNING: Do not use the pulse oximeter in an MRI or CT environment.

CAUTION: Keep the operating environment free of dust, vibrations, corrosive, or flammable materials, and extremes of temperature and humidity.

CAUTION: 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.

CAUTION: Never use sharp or pointed objects to operate the front-panel switches.

CAUTION: The battery must be taken out from the battery compartment if the device will not be used for a long time.

CAUTION: The device shall only be used if the battery cover is closed.

CAUTION: The battery must be proper disposed according to local regulation after their use.

3 Definitions and Symbols

Symbol	Description
Warning	The information you should know to protect patients and medical staff from possible injury
Caution	The information you should know to protect the equipment from possible damage
Note		The important information you should know

Section 2

Introduction

2.1 General

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

· Brief device description

· Product features

2.2 Brief Device Description

The 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 reduce the influence 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 use in family, hospital (including clinical use in internist/surgery, Anesthesia, pediatrics, intensive care and etc.) Oxygen Bar, social medical organizations, physical care in sports and etc.

2.3 Product Features

· Lightweight for carrying and Easy-To-Use.

· Manually adjust the direction of interface.

· Color OLED display, simultaneous display for testing value and plethysmogram.

Low Perfusion down to 0.3%.

· Visual alarm function. Real-time spot-checks.

· Low Battery voltage indicator.

· Automatically switch off.

· Standard two AAA 1.5V Alkaline Battery support more than 20 hours continuous work.

Section 3

Operation

3.1 Operation

3.1.1 Install battery

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

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

3.1.2 Turn the Pulse Oximeter on/off

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 Pulse Oximeter on. The oximeter will automatically be powered off when no finger in the device for longer than 16 seconds.

3.1.3 Read correspondent data from display screen.

Section 4

Cleaning and Disinfection

4.1 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.

CAUTION: Don’t use strong solvent. For example, acetone.

CAUTION: Never use an abrasive such as steel wool or metal polish.

CAUTION: Do not allow any liquid into the product, and do not immerse any parts of the device into any liquids.

CAUTION: Avoid pouring liquids on the device while cleaning.

CAUTION: Don’t remain any cleaning solution on the surface of the device.

Section 5

Troubleshooting and Maintenance

5.1 Maintenance

· Replace the batteries timely when battery indication is low. Clean surface of the Pulse Oximeter before it is used in diagnosis for patients.

· 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 -10-40℃ and humidity is 10%-80%.

· 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.

5.2 Troubleshooting

Table 5.2.1 troubleshooting

Problems	Possible Reason	Resolutions
Oxyhemoglobin or heart rate can not be shown normally	1.Finger is not plugged correctly. 2.Patient’s perfusion is too low to be measured.	1.Rety 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
Oxihemoglobin of heart rate is shown unstably	1.Finger might not be plugged deep enough 2.Finger is trembling or patient’s body is in movement status	1.Retry by plugging the finger 2.Try not to move, Let the patient keep calm.
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 automatically powered off when no signal is detected longer than 8 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

-- 60mm (L)*35mm (W)*32mm(D)

Weight

-- approx: 50g

( including 2 * AAA battery)

Outer box:

Dimensions

-- 80mm(L)*60mm(W)*52(D)

Gross Weight:70g

Outer carton:

- 510mm(L)*210mm(W)*235(H)

Gross Weight:15 kg

Classification:

Anti-electric Shock Type: Internally powered equipment

Anti-electric Shock Degree: Type BF equipment

EMC: Type B class I

Mode of operation: Continuous Operation Enclosure Degree of ingress

Protection:IPX4

Power

Internal	2*AAA 1.5v a 1kaline battery
Power Consumption	Smaller than 30 Ma(Normal)

Environmental

Operating Temperature	5℃ to 40℃
Storage Temperature	-10℃ to 50℃
Relative Humidity	15% to 80% non-condensing

Alarm default value

Parameter	Value
Hemoglobin saturation	Upper limit:100/ Bottom limit:94
Pulse rate	Upper limit:130/ Bottom limit:50

Electronics Parameters

Parameter		Value
Hemoglobin saturation display		35-100%
Pulse rate Display		30-250 BPM
Resolution	Hemoglobin Saturation	1%
	Pulse rate	1 BPM
Measure Accuracy	Hemoglobin Saturation	2% (70%-100%) Unspecified(≤70%)
	Pulse rate	2 BPM