CareTemp Touch Free Directions for Use Ver B

© 2014 Welch Allyn. All rights are reserved. To support the intended use of the product described in this publication, the purchaser of the product is permitted to copy this publication, for internal distribution only, from the media provided by Welch Allyn. No other use, reproduction, or distribution of this publication, or any part of it, is permitted without written permission from Welch Allyn. Welch Allyn assumes no responsibility for any injury to anyone, or for any illegal or improper use of the product, that may result from failure to use this product in accordance with the instructions, cautions, warnings, or statement of intended use published in this manual. Caution Federal US law restricts sale of the device identified in this manual to, or on the order of, a licensed physician. Software in this product is Copyright 2014 Welch Allyn or its vendors. All rights are reserved. The software is protected by United States of America copyright laws and international treaty provisions applicable worldwide. Under such laws, the licensee is entitled to use the copy of the software incorporated with this instrument as intended in the operation of the product in which it is embedded. The software may not be copied, decompiled, reverseengineered, disassembled, or otherwise reduced to human-perceivable form. This is not a sale of the software or any copy of the software; all right, title, and ownership of the software remain with Welch Allyn or its vendors. For information about any Welch Allyn product, call Welch Allyn Technical Support (http://www.welchallyn.com/ support) or visit www.welchallyn.com/en/about-us/locations.html.

106090 (CD) DIR 80018998 Ver. B

AViTA Corporation 9F., No. 78, Sec. 1 Kwang-Fu Rd., San-Chung District, 24158 New Taipei City, Taiwan

This manual applies to

Wellkang Ltd 29 Harley St. W1G 9QR London, U.K.

901094 Non Contact Thermometer

iii

Contents Symbols ... 1 Introduction ... 3

Intended use ... 3 General warnings and cautions ... 3

Using the thermometer ... 7

Button functions ... 7 Take a measurement ... 8 Recall a measurement ... 9 Use the timer ... 9 Change the temperature scale ... 9

Troubleshooting and error messages ... 11 Maintenance ... 13

Replace the batteries ... 13 Clean and disinfect the thermometer ... 13 Calibration testing ... 14 Disposal ... 15

Specifications ... 17 Guidance and manufacturer's declaration ... 19 Warranty ... 21

1

Symbols Documentation symbols WARNING The warning statements in this manual identify conditions or practices that could lead to illness, injury, or death.

Caution 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. This definition applies to both yellow and black and white symbols.

Consult operating instructions/directions for use (DFU).

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

A copy of the DFU is available on this website. A printed copy of the DFU can be ordered from Welch Allyn for delivery within 7 calendar days.

Shipping, storing, and environment symbols Temperature limits

Keep dry

This device shall be disposed of in accordance with national laws after its useful life.

Fragile

Humidity limitation

IP22

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)

2

Symbols

CareTemp™ Touch Free Thermometer

Miscellaneous symbols

ETL CLASSIFIED

Manufacturer

Reorder/Catalog number

Product identifier

European authorized representative

Global trade identification number

Serial number

Conforms to AAMI STD ES 60601-1, IEC STD 60601-1-6, ISO STD 80601-2-56; Certified to CSA STD C22.2 NO. 60601-1, NO. 60601-1-6, No. 80601-2-56

Type BF applied part

By prescription or order of licensed healthcare professional

Indicator symbols One short beep indicating a button press

Three beeps indicating the completion of a process

Two-second beep indicating an error

Battery level indicators 100 to 76 percent of useable battery capacity remaining Approximately 3,300 measurements

75 to 51 percent of useable battery capacity remaining Approximately 1,900 measurements

50 to 26 percent of useable battery capacity remaining Approximately 880 measurements

25 to 11 percent of useable battery capacity remaining Approximately 200 measurements

10 to 0 percent of useable battery capacity remaining When the battery flashes, no measurements can be taken

3

Introduction Intended use The CareTemp™ Touch Free thermometer is a clinical-grade device intended for the intermittent measurement of human body temperature in patients of all ages in a professional-use environment.

General warnings and cautions Warning and caution statements can appear on the thermometer, the packaging, the shipping container, or in this document. The thermometer is safe for patients and clinicians when used in accordance with the instructions and with the warning and caution statements presented in this manual. Before using the thermometer, familiarize all operating personnel with the general safety information in this summary. Specific 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 equipment or other property, or loss of patient data. WARNING Patient safety. The thermometer is designed for the intermittent measurement of the human body's temperature, and can be used upon people of all ages. The following recommendations must be carefully observed during the product's use. Any activities that are inconsistent with or do not take into account these recommendations could result in personal injury or could affect the accuracy of the thermometer itself. WARNING Patient safety. If the accuracy of any measurement is in question, check the patient's temperature with an alternate method and then check to verify the device is functioning properly. WARNING Safety risk. The thermometer battery must be kept strictly out of the reach of children, as ingestion of the battery could result in poisoning or other serious health risks. WARNING Safety risk. Always dispose of batteries in accordance with applicable legal regulations.

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Introduction

CareTemp™ Touch Free Thermometer

CAUTION Always use new batteries of the type and specification indicated in this manual. Mixing old and new batteries will shorten the battery life. CAUTION Do not use rechargeable batteries, as these may be of inferior quality and duration. The use of rechargeable batteries could compromise the performance of this device. CAUTION Leaking batteries can damage the device. Remove the batteries whenever the device is not expected to be used for an extended period of time (e.g. multiple months). CAUTION If a battery has leaked, put on protective gloves and clean the battery compartment with a dry cloth. CAUTION Federal US law restricts sale of the device identified in this manual to, or on the order of, a licensed healthcare practitioner CAUTION Proper measurement distance between 4 and 6 cm from the patient's forehead is essential to the accuracy of the temperature measurement determination. CAUTION Unauthorized modifications to the device are not permitted. Do not modify the product in any way without the manufacturer's prior authorization. CAUTION In order to avoid incorrect measurements, make sure that the lens on the thermometer's infrared sensor lens is clean and intact prior to use. CAUTION Avoid touching the infrared sensor lens directly with your fingers. CAUTION Do not expose the thermometer to extreme temperatures or humidity levels. Make sure that you follow the instructions provided in this manual. Do not expose to direct sunlight. CAUTION The thermometer is NOT waterproof. CAUTION Avoid dropping the device. CAUTION Do not autoclave. Follow only the cleaning procedures described in this manual. Note

Both the patient and the thermometer should be kept within the same environmental conditions for at least 30 minutes prior to each measurement.

Note

Avoid taking temperature measurements for at least 30 minutes after physical activity, bathing, swimming, consuming food or beverages, or spending time outdoors.

Note

Wait at least 1 minute between temperature measurements. Measurements performed too frequently could result in incorrect temperature readings.

Note

Contact Welch Allyn or your local Welch Allyn representative for any assistance with configuration, use, and maintenance operations.

Directions for use

Introduction

5

Note

Avoid pointing the infrared sensor at any heat source other than a patient. This might affect patient measurements.

Note

Avoid exposing the device to external heat sources. This might affect patient measurements.

Note

If possible, measurements should always be taken by pointing the infrared sensor at the same area of the forehead. Temperatures measured at different locations on the temples or on opposite sides of the head can vary considerably.

Note

Holding the thermometer in your hands for too long or exposing the device to external heat sources could result in distorted temperature readings. For this reason, the body temperature reading could result as being higher or lower than the actual value.

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Introduction

CareTemp™ Touch Free Thermometer

7

Using the thermometer Button functions

1.

Display

4.

Memory

2.

LED bar

5.

C/F (Celsius/Fahrenheit)

3.

Measure

6.

Pulse timer

8

Using the thermometer

CareTemp™ Touch Free Thermometer

Take a measurement 1. Press Measure to power on the thermometer. When the device is ready, a single dash appears on the screen, and a beeps sounds. 2. Position the thermometer between 4 and 6 cm from the center of the patient's forehead, and aim between the eyebrows.

Note

If the eyebrow area is covered with hair, sweat, or dirt, clean the area and wait 10 minutes to before taking a measurement.

Note

Hold the thermometer and the forehead steady during measurement. Movement can impact the measurement.

3. Press Measure. Slowly move the device toward or farther from the forehead. The arrow on the display flashes until the correct distance is achieved. Note

After pressing Measure, the thermometer allows 20 seconds to capture the measurement. If you press Measure again before the 20 second time limit is up, the process restarts. If the measurement is not completed in 20 seconds, the device displays Err ↑. Press Measure to restart the process.

4. When the correct distance is reached the LED bar will illuminate, three beeps sound, and the measurement is displayed. To repeat the process, return to step 2. Note

The complete measurement or Err ↑ message displays for 3 seconds. After 3 seconds, the thermometer returns to ready.

5. The thermometer automatically turns off after 10 seconds of inactivity.

Directions for use

Using the thermometer 9

Recall a measurement Pressing the Memory button (MEM) will display the temperature in memory with a MEM indicator. Memory is available directly from the off state, when no measurement is displayed, or immediately following a new measurement if a comparison to the prior reading is needed. Once the thermometer is powered off or a new measurement is initiated, the last temperature taken becomes the reading in memory. 1. Press and release MEM. The LCD displays the temperature stored in the thermometer's memory for 10 seconds. 2. Press and hold MEM for 3 seconds to force the measurement on the display to memory and clear the display. The thermometer beeps three times to indicate the measurement is moved to memory and the thermometer is ready to take a new measurement with a clear display. Note

It is not required to force a reading to memory. A new reading will automatically move to memory when the thermometer turns off or a new measurement is initiated.

Use the timer 1. Press and release the Timer button. The timer is activated. Audible beeps sound at 0, 15, 45, and 60 seconds. 2. Press the Timer button again to exit at any time. After the full 60 second cycle, the thermometer turns off automatically after 2 seconds.

Change the temperature scale 1. Press C/F to temporarily view the measurement in the alternate temperature scale. This scale conversion feature is available any time a temperature value is displayed, and can be used to continuously alternate between temperature scales. 2. Press and hold both the MEM and C/F buttons for 3 seconds to change the default scale. Three beeps sound to confirm the setting is changed. The alternate scale remains until one of the following occurs, returning the thermometer to the default temperature scale: •

The C/F button is pressed again.

•

A new measurement is taken.

•

Any other action is taken.

•

The thermometer turns off.

10

Using the thermometer

CareTemp™ Touch Free Thermometer

11

Troubleshooting and error messages Error message displayed

Possible cause

Suggested action

The thermometer distance to the patient is out of range

Take the measurement again, and make sure the thermometer is 4 to 6 cm away from the center of the patient's forehead, just between the eyebrows.

The ambient temperature of the room is outside the operating range of 60.8 °F to 104 °F (16 °C to 40 °C)

Move to a room with the proper ambient temperature and wait 30 minutes for the thermometer to stabilize.

The measurement is lower than 93.2 °F Take the measurement again. Follow (34 °C) the steps in the "Take a measurement" section.

The measurement is higher than 109.4 Take the measurement again. Follow °F (43 °C) the steps in the "Take a measurement" section.

Flashing battery symbol on the display The battery is low on power Blank display

Replace the battery with two AAA (LR03) alkaline batteries.

The thermometer does not have power Make sure the battery has been loaded properly. Contact your local Welch Allyn service center or representative if the thermometer still does not function.

12

Troubleshooting and error messages

CareTemp™ Touch Free Thermometer

13

Maintenance Replace the batteries The thermometer comes with two AAA (LR03) batteries. Replace with two new AAA (LR03) batteries when the flashing battery symbol appears on the display 1. Use a Phillips screwdriver to loosen the battery cover screw. 2. Slide open the battery cover and remove the batteries. 3. Replace the batteries. Make sure to align the batteries as indicated inside the battery compartment. 4. Replace the battery cover and tighten the battery cover screw. Remove the batteries before storing the thermometer for an extended period of time.

Clean and disinfect the thermometer The thermometer can be cleaned and an intermediate-level of disinfection can be achieved using the following method. CAUTION Never submerge the thermometer in water or any other liquid CAUTION Never use abrasive cleaning agents, thinners or benzene for cleaning and never immerse the instrument in water or other cleaning liquids. CAUTION Never insert a sharp object into the scanner area or any other open surface on the thermometer. CAUTION Do not use unapproved cleaning or disinfection agents. Use of these agents may cause damage to components. CAUTION Do not use chemicals other than isopropyl or ethyl alcohol on the lens.

Cleaning the sensor window Slightly moisten a cotton swab or cloth with isopropyl or ethyl alcohol and gently wipe the surface of the lens using a side-to-side (not circular) motion. Avoid touching the lens except when cleaning is required.

14

Maintenance

CareTemp™ Touch Free Thermometer

Cleaning the thermometer Use a pre-moistened wipe or soft cloth slightly moistened with an approved cleaner to gently clean the thermometer.

Disinfecting the thermometer Use a pre-moistened wipe or soft cloth slightly moistened with an approved disinfectant to disinfect the thermometer. Follow the manufacturers recommendations. Note

After cleaning or disinfecting, wait at least 10 minutes before taking another measurement.

Approved cleaning agents Use only the following approved cleaning agents on the thermometer: CaviWipes

Super HDQ® L10

Sani-Cloth® Plus

Cleancide

Super Sani-Cloth®

Clorox HealthCare Bleach Germicidal Cleaner

Sani-Cloth® Bleach

Virex II (256)

Oxiver Tb

Tuffie5 Cleaning Wipes

Clinell® Universal Wipes

70% IPA

Accel INTERVention

10% bleach (.5% - 1% Sodium Hypochlorite)

Accel TB

Desko

Additional cleaning agents may be periodically evaluated for compatibility. If your cleaning agent is not listed, contact Welch Allyn to determine if additional cleaning agents are approved for use. Welch Allyn has validated these instructions as being capable of preparing the thermometer for re-use. You must ensure that cleaning and disinfection as actually performed by your personnel, with your equipment and materials, achieves the desired result. This may require validation and routine monitoring of your actual process.

Calibration testing The thermometer is calibrated at the time of manufacture. If the thermometer is operating according to these instructions, periodic readjustment is not required. Welch Allyn recommends checking calibration on an annual basis or whenever clinical accuracy of the thermometer is in question. Procedures for checking calibration are outlined in the Welch Allyn 9600 Plus Calibration Tester directions for use (P/N 701754). These recommendations do not supersede any legal requirements. You must always comply with legal requirements for the control of the measurement, functionality, and

Directions for use

Maintenance

accuracy of the device. These controls are required by the scope of relevant laws, directives or ordinances where the device is used.

Disposal Thermometer The thermometer contains no hazardous materials. Discard without environmental risk. Remove the batteries before disposal. Battery Dispose of empty batteries in accordance with national or local regulations.

15

16

Maintenance

CareTemp™ Touch Free Thermometer

17

Specifications Type

Touch-free infrared thermometer

Model no.

NT18, REF 901094, #105801

Displayed temperature range

93.2 to 109.4 °F (34 to 43 °C)

Display resolution

0.1 °F (0.1 °C)

Laboratory accuracy

±0.4 °F (±0.2 °C) for the range 93.2 to 109.4 °F (34 to 43 °C)

Clinical accuracy

±0.5 °F (±0.3 °C) for the range 93.2 to 109.4 °F (34 to 43 °C)

Display

Liquid crystal display, four digits plus special icons

Operating temperature

60.8 to 104 °F (16 to 40 °C )

Operating humidity

Up to 85% non condensing

Storage temperature

–13 to 131 °F (–25 to 55 °C)

Storage humidity

Up to 85% non condensing

Automatic power off

Approximately 10 seconds after last measurement has been taken

Battery

2 × 1.5V AAA (LR03)

Battery life

3,300 measurements

Weight

100.5g (with battery), 78.0g (without battery)

Dimensions

159.3 x 41.3 x 55.8 mm

Software version

NT18 V001

Standards ASTM 1965-98

EN 12470-5:2003

MDD (93/42/EEC) Annex II

ISO STD 80601-2-56