Welch Allyn CareTemp Touch Free Directions For Use Manual
CareTemp™ Touch Free
Thermometer
Directions for use
© 2018 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 2018Welch 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.
DIR 80022132 Ver. B
Revised: 2018-07
AViTA Corporation
9F., No. 78, Sec. 1 Kwang-Fu Rd.,
San-Chung District,
24158 New Taipei City, Taiwan
This manual applies to 901094 Non Contact Thermometer
Wellkang Ltd
29 Harley St.
W1G 9QR
London, U.K.
Contents
Symbols ................................................................................................... 1
Introduction ............................................................................................. 3
Using the thermometer .......................................................................... 7
iii
Intended use ........................................................................................................ 3
General warnings and cautions ............................................................................ 3
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 ............................................................................................................. 14
Specifications ........................................................................................ 17
Guidance and manufacturer's declaration .......................................... 19
EMC compliance ................................................................................................ 19
Emissions and immunity information ................................................................. 19
Warranty ................................................................................................ 25
Contents CareTemp™ Touch Free Thermometer
iv
Symbols
Documentation symbols
1
WARNING The warning statements in
this manual identify conditions or
practices that could lead to illness, injury,
or death.
Consult operating instructions/directions
for use (DFU).
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.
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.
Meets essential requirements of
European Medical Device Directive
93/42/EEC.
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)
ETL CLASSIFIED
Symbols CareTemp™ Touch Free Thermometer
2
Miscellaneous symbols
Manufacturer
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
By prescription or order of licensed
healthcare professional
Indicator symbols
One short beep indicating a button press Three beeps indicating the completion of
Reorder/Catalog number
Type BF applied part
a process
Two-second beep indicating an error
Battery level indicators
100 to 76 percent of useable battery
capacity remaining
Approximately 3,300 measurements
50 to 26 percent of useable battery
capacity remaining
Approximately 880 measurements
10 to 0 percent of useable battery
capacity remaining
When the battery flashes, no
measurements can be taken
75 to 51 percent of useable battery
capacity remaining
Approximately 1,900 measurements
25 to 11 percent of useable battery
capacity remaining
Approximately 200 measurements
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.
3
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.
Introduction CareTemp™ Touch Free Thermometer
4
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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