ADC Adtemp 429 Manual de usuario

PLEASE NOTE:

THIS MEDICAL INSTRUMENT MUST BE

USED ACC RDING T INSTRUCTI NS

T ENSURE ACCURATE READINGS.

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Non-Contact

Thermometer

Model 429

User’s Manual

A Special

Thank You...

Thank you for choosing an ADC®AdtempTM Non-Contact thermometer.

We're proud of the care and quality that goes into the manufacture 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.

You'll quickly appreciate the results, for you now own one of the finest

Non-Contact thermometers that money can buy.

With proper care and maintenance, your ADC®AdtempTM thermometer is

sure to provide you with many years of dependable service. Please read

the following instructions and general information which will prove helpful

in allowing you to enjoy your ADC®product.

Read this booklet thoroughly before attempting to use your new

ADC®AdtempTM thermometer.

Thank you for your patronage. t is indeed our pleasure to serve you.

Sincerely,

American Diagnostic Corp.

AdtempTM 429 - Instruction Manual

Table of Contents

1. Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5

2. Introduction / Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . .5

3. General Warnings and Cautions . . . . . . . . . . . . . . . . . . . . .5-7

4. Using the Thermometer . . . . . . . . . . . . . . . . . . . . . . . . . . .8-9

4a. Controls and Features . . . . . . . . . . . . . . . . . . . . . . . . . . . .8

4b. LED Screen/Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8

4c. Selecting a Scan Mode . . . . . . . . . . . . . . . . . . . . . . . . .8-9

4d. Changing the Temperature Scale . . . . . . . . . . . . . . . . . . . .9

5. Taking a Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . .9-10

6. Memory Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

7. Troubleshooting / Error Messages . . . . . . . . . . . . . . . . . . . .12

8. Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-14

8a. Replacing the Batteries . . . . . . . . . . . . . . . . . . . . . . .12-13

8b. Cleaning and Disinfecting . . . . . . . . . . . . . . . . . . . . .13-14

9. Calibration Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14

10.Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14

11.Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . .15

12.Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16

13.Guidance and Manufacturer’s Declaration . . . . . . . . . .16-18

14.Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18

15.Contact Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19

t^okfkdW The warning statements in this manual identify conditions or practices that

could lead to illness, injury, or death.

`^rqflkW The caution statements in this manual identify conditions or practices that

could result in damage to the equipment or other property, or loss of data.

Consult instructions for use (IFU).

Meets essential requirements of European Medical Device Directive 93/42/EEC.

0197

1. Symbols

Documentation Symbols

Shipping, Storing, and Environment Symbols

Temperature Limits: -13°F/-25°C - 131°F/55°C

Keep Dry

Electronic Waste: Dispose of this device in accordance with local or national

regulations

Fragile

Humidity Limitation: Up to 85%

This product meets the basic safety and essential performance requirements indicated in

the IP22 conditioning test (IP22: Protection level against solid foreign objects and falling water)

I 22

-13° F

-25° C

131° F

55° C

15%

85%

Miscellaneous Symbols

Manufacturer

Product Identifier

European authorized representative

Global trade identification number

Serial number

REF

EC REP

GTIN

2. Introduction / Intended Use

Intended use

The Adtemp™ Non Contact thermometer is a clinical-grade device in-

tended for the intermittent measurement of human body temperature

in patients of all ages. It can also be used to measure the temperature

of objects.

3. General Warnings and Cautions

Warning and caution statements may appear on the thermometer, its

packaging, shipping container, or in this instruction manual.

This thermometer is safe for patients and clinicians when used in accor-

dance with the instructions and with the warning and caution statements

included in this manual. Before using the thermometer, users must famil-

iarize themselves with the general safety information included below. Spe-

cific warnings and cautions are also found throughout this manual.

• Failure to understand and observe any warning statement in this

manual could lead to patient illness, injury, or death.

• Failure to understand and observe any caution statement in this

manual could lead to damage to the thermometer or other property,

damage to the surrounding environment, or loss of patient data.

• High, prolonged fever requires immediate medical attention,

especially for young children.

Warning: Failure to review and adhere to the recommendations

presented in this manual could result in personal injury or could

affect the accuracy of the thermometer itself.

Miscellaneous Symbols

Type BF applied part

Battery Level Indications

ow battery (thermometer can still be used)

ow battery- the batteries must be replaced before further operation

Warning: If the accuracy of any measurement is in question or the use

of this thermometer is not appropriate due to patient condition,

check the patient's temperature with an alternate method and then

check to verify the device is functioning properly by comparing it

against a calibrated reference device.

Warning: Keep this thermometer and its batteries out of the reach of

children. Do not allow children to take their temperature with this

thermometer unattended.

Warning: Dispose of this thermometer and its batteries in accordance

with local or national regulations for electronic waste.

Warning: This product may contain a chemical known to the state of

California to cause cancer, birth defects, or other reproductive harm.

Caution: When replacing the batteries, always replace both batteries and

ensure that they are of the type and specification indicated in this manual.

bserve correct polarity when inserting new batteries.

Caution: Do not use rechargeable batteries. The use of rechargeable

batteries may compromise the performance of this device.

Caution: Remove the batteries whenever the device is not expected to be

used for an extended period of time.

Caution: If battery leakage occurs, fully clean the battery compartment

using personal protective equipment prior to re-use.

Caution: bserve proper measurement distance, starting between 4 and

6 cm from the patient's forehead. This is essential to the accuracy of the

measurement.

Caution: Do not modify or disassemble this device in any way without

prior authorization.

Caution: To avoid accuracy concerns, make sure that the thermometer’s

lens is clean and intact prior to use and after measurement is complete.

Caution: Avoid touching the lens directly with your fingers.

Caution: Do not expose the thermometer to extreme temperatures or

humidity levels. Do not expose to direct sunlight.

Caution: The thermometer is not waterproof; do not immerse in water or

any other liquid.

Caution: Avoid dropping the device or exposing it to heavy shock or

vibration.

Caution: Do not autoclave. Follow only the cleaning procedures described

in this manual.

Caution: Stop using this device if it operates erratically or if the display

malfunctions.

Caution: Contact ADC or your local ADC representative for any assistance with

this device. Refer to the warranty section of this manual for contact details.

Caution: Allow 30 minutes for both patient and thermometer to become

accustomed to existing environmental conditions prior to measurement.

Caution: Wherever possible, measurements should be taken by

pointing the infrared sensor at the same area of the forehead. Tem-

peratures measured at different measurement sites on the temples,

on opposite sides of the head, or on different body parts can vary

considerably.

Caution: Avoid taking temperature measurements for at least 30 min-

utes after physical activity, bathing, swimming, consuming food or

beverages, or spending time outdoors.

Caution: Wait at least 1 minute between temperature measurements.

Repeating measurements more often may compromise the accuracy

of the readings.

Caution: Avoid pointing the infrared sensor at any heat source other

than a patient.

Caution: Avoid exposing the device to external heat sources.

Caution: Holding the thermometer for an excessive period of time or

exposing the device to external heat sources may result in distorted

temperature readings.

4. Using the Thermometer

4a. Controls and Features

4b. LED Screen/Display

4c.Selecting a Scan Mode

With the power on, press the Human/Object button to switch between scan

modes. There are 4 modes available, including Human, Object, Human/Night,

and Object/Night mode (in order). The thermometer’s volume will be muted in

both Human/Night mode as well as Object/Night mode, and the Moon symbol

will appear on the LCD in both Night modes.

Note: Each press of the Human/Object button is accompanied by a beep

sound to confirm that the setting is activated. (excluding Night modes)

4d.Changing the Temperature Scale

The Adtemp™ 429 Non Contact Thermometer can display readings

in either Fahrenheit (F) or Celsius (C). The default temperature scale

is Fahrenheit. To change the scale to Celsius, power the device on,

then press and hold the Human/Object and Memory buttons

simultaneously for 1 second. Pressing these buttons again will

change the scale back to Fahrenheit. Note: Removing the batteries

will reset the scale to the default setting.

5.Taking a Measurement

1. Press the Measure button to power on the thermometer. The unit will run

a self-test and the LCD will briefly display all of its symbols during this time.

When the device is ready, ‘00’ will appear on the screen, and the thermometer

will beep twice.

2. Select the desired mode by pressing and releasing the Human/Object button.

Note: When taking a patient’s temperature, ensure that the thermometer is in

Human mode; the Human symbol will appear on the display. Refer to Section

4c for instructions on selecting a different scan mode.

3. Position the thermometer about 2 inches (5 cm) from the center of the

patient's forehead

with the sensor aimed

between the eyebrows.

Note: f the patient’s skin is covered with hair, sweat, or dirt, clean the area

and wait 10 minutes before taking a measurement.

Note: Ensure that the thermometer is held firmly during measurement and that

the patient does not move until the measurement is complete. Patient movement

can impact the measurement.

4. Press and release the Measure button making sure not to obstruct your

view of the LED display or the buttons area.

5. Slowly move the device towards the patient’s forehead. The unit will

beep continuously and a series of dash icons forming two circles

will rotate on the display. Once the correct distance is reached

(about 1 inch or 3 cm), an amber light will flash just below the

Mode and Memory buttons. The unit will emit a short beep

(except in night mode), and the backlit display will illuminate

when the measurement is complete.

Note: f the distance of the thermometer is too far from or too close to the patient’s

forehead, the dash icons will continue to rotate and the unit will beep (except in

night mode) UNT L the correct distance is obtained. Once the Measure button is

pressed and released, you will have 20 seconds to obtain a temperature reading.

After 20 seconds the unit returns to standby mode.

6. To repeat the process, return to step 2.

7. The thermometer automatically turns off (with a single beep) after 30

seconds of inactivity.

Note: The device cannot be turned off manually.

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