Homedics PX-131CO Bedienungsanleitung

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INTRODUCTION

In case of modifications and software upgrades, the information

contained in this document is subject to change without notice. The

Manual describes, in accordance with the Pulse Oximeter’s features

and requirements, main structure, functions, specifications, correct

methods for transportation, installation, usage, operation, repair,

maintenance and storage, etc., as well as the safety procedures to

protect both the user and equipment. Refer to the respective sections

for details.

Please read the Manual very carefully before using this equipment.

These instructions describe the operating procedures that must be

followed. Failure to follow these instructions can cause measuring

abnormality, equipment damage and personal injury.

The manufacturer is NOT responsible for the safety, reliability and per-

formance issues and any monitoring abnormality, personal injury and

equipment damage due to user’s negligence of the operation instruc-

tions. The manufacturer’s warranty service does not cover such faults.

Due to product improvements, the specific products you received may

have slight differences to the description in this User Manual.

This product can be used repeatedly, with a life expectancy of 3 years.

WARNING

An uncomfortable or painful feeling may appear if using the device

ceaselessly, especially for the microcirculation barrier users. It is rec-

ommended that the sensor should not be applied to the same finger

for over 2 hours.

• Use the pulse oximeter only for its intended use. DO NOT use on a

finger that has an edema and tender tissue.

• The light (the infrared is invisible) emitted from the device is

harmful to the eyes. DO NOT stare into the light.

• User cannot use enamel or other makeup on the finger when using.

• User’s fingernail cannot be too long.

• Please read the relative content about the clinical restrictions

and cautions.

• This device is not intended for treatment or diagnosis.

IMPORTANT PRODUCT NOTICES AND SAFETY INSTRUCTIONS

• Check the main unit and all accessories periodically to make

sure that there is no visible damage that may affect user’s safety and

monitoring performance about cables and transducers. It is

recommended that the device should be inspected once a week at

least. When there is obvious damage, stop using the oximeter.

• DO NOT disassemble this device. If in need of repair, refer to the

warranty section of this manual.

• The oximeter cannot be used together with devices not specified

in the User’s Manual.

• Use only the accessories recommended in this manual, or included

in the box.

• Under normal usage conditions, this device does not require

calibration or technical maintenance other than infrequent

replacement of the battery.

WARNINGS:

• Explosive hazard - DO NOT use the oximeter in an environment with

inflammable gas such as some ignitable anesthetic agents.

• A person with allergies to rubber cannot use this device.

• Follow local ordinances and recycling instructions regarding

disposal or recycling of the device and device components,

including batteries.

• When using your pulse oximeter, basic precautions should always

be followed. Please read and follow all instructions and warnings

before using this product. Save these instructions for future

reference.

• Please don’t measure this device with function test paper for

the device’s related information.

• DO NOT service or maintain this device while in use.

• The user is an intended operator.

• The probe of the device is the applied part.

ATTENTION:

• Keep the oximeter away from dust, vibration, corrosive

substances, explosive materials, high temperature and

moisture.

• If the oximeter gets wet, please stop operating it.

• When it is carried from cold environment to warm or humid

environment, please do no use it immediately.

• DO NOT operate keys on front panel with sharp materials.

• High temperature or high pressure steam disinfection of the

oximeter is not permitted.

• Refer to the “Care and Maintenance” section for instructions

on cleaning and disinfection.

• DO NOT immerse the unit in water as this will result in damage to

the unit.

• When cleaning the device with water, the temperature should be

lower than 140°F (60°C).

• As to the fingers which are too thin or too cold, it would probably

affect the normal measure of the users’ SpO

2

and pulse rate, please

clip the thick finger such as thumb and middle finger deeply enough

into the probe.

• DO NOT use the device on infant or neonatal users.

• The product is suitable for adults weighing between 88 lbs to

242.5 lbs (40 kg to 110 kg).

• The device may not work for all users. If you are unable to achieve

stable readings, discontinue use.

• The update period of data is less than 5 seconds, which will

change according to the user’s pulse rate.

• The waveform is normalized. Please read the measured value

when the waveform on screen is equably and steady-going, here

this measured value is optimal value, and the waveform at the

moment is the standard one.

• If some abnormal conditions appear on the screen while using,

pull out the finger and reinsert to restore normal use.

• The lanyard attached to the product is made from non-allergic

material, if particular groups are sensitive to the lanyard, stop

using it. DO NOT wear around the neck to avoid risk of injury

to the neck.

• The instrument does not have a low-voltage alarm function, it only

shows the low-voltage, please change the battery when the battery

energy is used up.

• The instrument does not have an alarm function. Do not use the

device in situations where alarms are required.

• Batteries must be removed if the device is going to be stored for

more than one month, or else the batteries may leak.

• A flexible circuit connects the two parts of the device. DO NOT twist

or pull on the connection.

INDICATION FOR USE:

The pulse oximeter is a non-invasive device intended for the spot-

check of oxygen saturation of arterial hemoglobin (SpO

2

) and pulse

rate of adults through the finger in home use environments. For use

with sporting and aviation activities, and to monitor heart rate during

exercise. Not intended for single use and out-of-hospital transport use.

OVERVIEW

The pulse oxygen saturation is the percentage of HbO

2

in the total Hb

in the blood, so-called the O

2

concentration in the blood. It is an im-

portant bio-parameter for the respiration. For the purpose of measuring

the SpO

2

more easily and accurately, our company developed the

Pulse Oximeter. At the same time, the device can measure the pulse

rate simultaneously.

The Pulse Oximeter features in small volume, low power consumption,

convenient operation and being portable. It is only necessary for user

to put one of his fingers into a fingertip photoelectric sensor for mea-

surement, and the display screen will directly show measured value of

Hemoglobin Saturation.

FEATURES:

• Operation of the product is simple and convenient.

• The product is small in volume, light in weight and convenient

to carry.

• Power consumption of the product is low and the 2 originally

equipped AAA batteries can be operated continuously for 20 hours.

• The product will enter standby mode when no signal is in the

product within 5 seconds.

• Display direction changes automatically for easy viewing.

PULSE OXIMETER

INSTRUCTIONS FOR USE

MAJOR APPLICATIONS AND SCOPE OF APPLICATION

The Pulse Oximeter can be used in measuring pulse oxygen saturation

and pulse rate through the finger. The product is suitable for family use

(It can be used before or after doing sports, and it is not recommended

to use the device during the process of doing sports).

The problem of overrating would emerge when the user is

suffering from toxicosis which is caused by carbon monoxide,

the device is not recommended to be used under this circumstance.

ENVIRONMENT REQUIREMENTS

Storage Environment

a. Temperature: -40°F (-40°C) ~ +140°F (+60°C)

b. Relative humidity: ≤95%

c. Atmospheric pressure: 500 hPa ~ 1060 hPa

Operating Environment

a. Temperature: 50°F (10°C) ~ 104°F (40°C)

b. Relative Humidity: ≤75%

c. Atmospheric pressure: 700 hPa ~ 1060 hPa

PRINCIPLE AND CAUTION

Principle of Measurement

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 Characteristics of Reductive Hemoglobin (Hb)

and Oxyhemoglobin (HbO

2

) in glow & near-infrared zones. Operation

principle of the instrument 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 tip through perspective clamp

finger-type sensor. Then measured signal can be obtained by a pho-

tosensitive element, information acquired through which will be shown

on screen through treatment in electronic circuits and microprocessor.

Figure 1. Operating Principle

Caution

1. The finger should be placed properly (refer to Figure 7), or else it

may cause inaccurate measurement.

2. The SpO

2

sensor and photoelectric receiving tube should be arranged

in a way with the subject’s arteriole in a position there between.

3. The SpO

2

sensor should not be used at a location or limb tied with

arterial canal or blood pressure cuff or receiving intravenous injection.

4. Make sure the optical path is free from any optical obstacles like

rubberized fabric.

5. Excessive ambient light may affect the measuring result. It includes

fluorescent lamp, dual ruby light, infrared heater, direct sunlight, etc.

6. Strenuous action of the subject or extreme electrosurgical

interference may also affect the accuracy.

7. User cannot use enamel or other makeup on the finger when using.

CLINICAL RESTRICTIONS

1. As the measure is taken on the basis of arteriole pulse, substantial

pulsating blood flow of subject is required. For a subject with weak pulse

due to shock, low ambient/body temperature, major bleeding, or use of

vascular contracting drug, the SpO

2

waveform (PLETH) will decrease. In

this case, the measurement will be more sensitive to interference.

2. For those with a substantial amount of staining dilution drug (such as

methylene blue, indigo green and acid indigo blue), or carbon

monoxide hemoglobin (COHb), or methionine (Me+Hb) or thiosalcylic

hemoglobin, and some with icterus problem, the SpO

2

determination

by this monitor may be inaccurate.

3. The drugs like dopamine, procaine, prilocaine, lidocaine and butacaine

may also be a major factor blamed for serious error of SpO

2

measure.

4. As the SpO

2

value serves as a reference value for judgement of

anemic anoxia and toxic anoxia, some users with serious anemia

may also report good SpO

2

measurement.

TECHNICAL SPECIFICATIONS

1.Display Format: LCD Display;

SpO

2

Measuring Range: 0% ~ 100%;

Pulse Rate Measuring Range: 30 bpm ~ 250 bpm;

Pulse Wave Display: bar-graph display and the waveform display.

2. Power Requirements: 2 x 1.5 V AAA alkaline battery (or use

rechargeable batteries), adaptable range: 2.6 V ~ 3.6 V.

3. Power Consumption: Less than 50 mA.

4. Resolution: 1% for SpO

2

and 1 bpm for Pulse Rate.

5. Measurement Accuracy: ±2% in stage of 70% ~ 100% SpO

2

, and

meaningless when stage being smaller than 70%. ±2 bpm or ±2%

(select larger) for Pulse Rate. Clinical Trial: SpO

2

regression plot and

Bland-Altman plot, Refer to Figure 2 & Figure 3.

6. Measurement Performance in Weak Filling Condition: SpO

2

and

pulse rate can be shown correctly when pulse-filling ratio is 0.4%.

SpO

2

error is ±4%, pulse rate error is ±2 bpm or ±2% (select larger).

7. Resistance to surrounding light: The deviation between the value

measured in the condition of man-made light, indoor natural light

and darkroom is less than ±1 %.

8. It is equipped with a switch function: The product will enter standby

mode when no signal is in the product within 5 seconds.

9. Optical Sensor: Red light (wavelength is 660 nm, 6.65 mW), infrared

(wavelength is 905 nm, 6.75 mW).

Figure 2. SpO

2

regression plot

Figure 3. Bland-Altman plot

PRODUCT SET UP

Glow and Infrared-ray

Emission Tube

Glow and Infrared-ray

Receipt Tube

Model: CMS50D1A

P/N: PX-131COB

Doc# L-03969, Rev.1

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