Instructions for use

www.domotherm.de
Table of contents Intended use
Intended use 3 Domotherm® E is an electronic infrared thermometer for regular meas-
urement and monitoring of the human body temperature in the ear
How it works 3 canal. It is suitable for adults and children from the age of 6 months.

Safety instructions
Important patient information 5
Important technical information 6 How it works
Operating the device The device measures the infrared energy that is emitted by the middle
Device description 7 ear and the surrounding tissue. A sensor takes this thermal radiation
Display 8 and converts it into temperature values. The measured temperature
Initial commissioning of the device 9 appears on the display.
Setting the date, time and temperature unit (°C/°F) 9
Switching the beep on/off 10 Measurements taken on the surrounding tissue of the ear canal will
Avoiding inaccurate measurements 11 result in lower measured values and can lead to an incorrect diagnosis
Measuring the temperature 12 of a fever. You should therefore follow the instructions on avoiding
Classifying the measured values 14 inaccurate measurements on page 11.
Extended measuring range 15
Retrieving saved readings 16 The innovative infrared technology enables the body temperature to
Deleting the measured value memory 17 be measured in just one second. This makes it particularly suitable for
Replacing the battery 17 use with children. A measurement can even be taken as a child sleeps
without disturbing them.
Technical information
Error messages 19 The thermometer has no probe cover, making it particularly us-
Technical data 20 er-friendly and cost-effective. As no replacement probe covers need
Customer service 21 to be purchased, there are no follow-up costs.
Metrological inspection 21
Explanation of symbols 22 Its ergonomic design makes the thermometer easy and convenient
Disposal 22 to use.

Cleaning and care 23 It features a measured value memory that stores the last 12 measured
temperature values along with the date and time of the measure-
Warranty 24 ment. This allows you to track the change in temperature over time.

Fever alarm: If temperature values above 37.5 °C are measured, then

three short beeps and a red background light on the display indicate
that this is a raised temperature.
EN-2 EN-3
How it works Safety instructions
Silent mode: The thermometer’s beep function can be switched off. Important patient information
You may wish to do this if, for example, you do not wish to disturb a
sleeping child when performing the measurement. • The device must be used solely for the purpose described in these
instructions for use. The manufacturer shall not be held liable for
Illuminated measuring tip: The LED light on the measuring sensor any damage caused by improper handling.
makes it easier to position the thermometer in the dark.
• Do not drink, eat or play sport before or during the measurement.
Reminder function for cleaning the measuring tip: The measuring tip
must be cleaned after each use. When you switch off the thermom- • Do not use the thermometer in environments with a high level of
eter, a symbol appears on the device display and the measuring tip humidity.
flashes as a reminder.
• Earwax in the ear canal can result in lower measured temperature
The thermometer has an extended measuring range of 0 °C to 100 °C. values. Before taking the measurement, make sure that the ear ca-
As well as measuring body temperature in the ear, the thermometer nal is clean.
can therefore also be used to measure surface temperatures, e.g. the
surface temperature of the milk in baby bottles, the surface temper- • If earwax accumulates on the measuring sensor, this can cause
ature of the bathing water for infants or the ambient temperature. inaccuracies in the temperature measurement and may lead to
cross-infection between different users. When cleaned correctly,
This thermometer has been clinically tested and verified as reliable the thermometer is completely hygienic and can be used by the
and accurate when used in accordance with the instructions for use. whole family.

Read these instructions for use carefully to ensure that you have un- • If the measured value is not consistent with the patient’s state of
derstood all of the functions and the safety information. health, or if the measured value is unusually low, repeat the meas-
urement after waiting 15 minutes. Check the result with a different
Take the time to familiarise yourself with the thermometer. Perform method of measuring body temperature.
test measurements and practice using the thermometer in the correct
way until you achieve consistent measured values. Follow the instruc- • The values measured using this device do not provide a diagnosis.
tions for avoiding inaccurate measurements on page 11. They are no substitute for visiting a doctor. Do not rely solely on
the result obtained; always take the patient’s other symptoms into
Caution: The measuring tip must be cleaned after each use! Any account too. In case of doubt, please call a doctor or paramedics
contamination of the measuring tip will cause malfunctions and to help.
inaccurate measurements. It is essential to follow the cleaning
instructions on page 23. • The thermometer contains small parts (e. g. battery) that could be
swallowed by children. Do not leave the device unattended with
children.

EN-4 EN-5
Safety instructions Operating the device
Important technical information Device description
• The device is not waterproof. Never immerse it in water or any oth-
er liquids. For information on cleaning and disinfection, please see 2 3
the instructions on page 23. 1
4
• Ensure that you do not drop the device or subject it to shocks. Pro-
5
tect the device against extreme temperatures, dirt, dust, powerful
sunlight, heat and cold. 6

• Do not use the device if you find signs of damage or any other
abnormality.

• Never open the device (except to replace the battery). If the unit
has been opened, it must be subjected to a metrological inspection
by an authorised institution.

• The use of this device in the vicinity of mobile phones, microwaves

8
or other devices with strong electromagnetic fields can cause mal- 7
functions. Maintain a distance of at least one metre from such de-
vices when using the thermometer. If you cannot maintain the min-
imum distance, check that the thermometer is working correctly
before you use it. 1 Measuring sensor 5 MEMO button
(memory button)
• If the device is not being used for an extended period of time, re- 2 Illuminated measuring tip
move the battery. 6 O/I button (on/off button)
3 Display
• The device contains sensitive parts and must therefore be handled 7 Battery compartment
with care. See the storage and transport conditions as well as the 4 START button
operating conditions on page 20. (start measurement) 8 MODE button

• If the device has been stored at temperatures below 10°C or above

40°C, leave it to stand at room temperature for at least 2 hours
before using it.

EN-6 EN-7
Operating the device Operating the device
Display Initial commissioning of the device
1 2 3 • Open the battery compartment (see page 17). Pull the transparent
battery contact separation strip that protrudes out of the battery
compartment and remove it from the housing in the direction indi-
cated by the arrow. Close the battery compartment again.

4 • The device turns on and switches to SET mode for entering the basic
settings (date, time, temperature unit).

9 5 Setting the date, time and temperature unit (°C/°F)

8 4 Before using the device for the first time, set the
7 date and time so that the measurements can be
saved together with the date and time.

6 • During initial commissioning of the device or af-

ter replacing the battery, the device automatically
switches to SET mode for entering the basic set- Figure 1
1 Cleaning reminder 5 Battery display tings (Figure 1).

2 Ambient temperature 6 Beep • To access SET mode manually, press and hold the
START button for at least five seconds with the
3 Ready for measurement 7 Time device switched off.

4 Temperature unit °C (Celsi- 8 Date • Press the START button again. You are now able
us)/°F (Fahrenheit) to set the year (Figure 2).
Figure 2
9 Memory mode
• Press the MODE button to increase the year or the
MEMO button to reduce the year. Once the cor-
rect value is set, confirm the entry by pressing the
START button.

• You are now able to set the month. (Figure 3).

Press the MODE button to increase the value dis-
Figure 3
EN-8 EN-9
Operating the device Operating the device
played, and press the MEMO button to reduce the Avoiding inaccurate measurements
value displayed. Set the correct month and con-
firm the entry by pressing the START button. Taking measured values directly from the middle ear (eardrum) en-
sures the most accurate temperature measurement. Measurements
• Repeat these steps to enter the day (Figure 3) and taken on the surrounding tissue of the ear canal will result in lower
the hours and the minutes (Figure 4). measured values and can lead to an incorrect diagnosis of a fever.

• You are now able to set the temperature unit (Fig- Figure 4 For this reason, it is very important to position the thermometer in the
ure 5). Press the MODE button to switch between ear correctly. It is essential to follow the instructions on positioning the
°C (Celsius) and °F (Fahrenheit). Set the required thermometer in the ear in the chapter “Measuring the temperature“
temperature unit and confirm the entry by press- on page 12.
ing the START button.
Rest for at least 5 minutes before taking the measurement.
• The basic settings have now been configured. The
device switches off. Always measure the temperature in the same ear, as the temperature
values may vary from ear to ear.
Figure 5
If no button is pressed for approximately 30 seconds
while configuring the basic settings, the device switches off automat- In the following situations, you should take three consecutive tem-
ically. However, any entries that have already been confirmed will still perature measurements in the same ear and take the highest result as
be saved. the measured value:

After changing the battery, you must enter the date and time again. – In children under three years of age with a vulnerable immune sys-
tem where the presence or absence of fever may be critical.

Switching the beep on/off – If you are familiarising yourself with the device and are practis-
ing how to use the infrared ear thermometer correctly until you
With the device switched off, press the MODE button. The current achieve consistent measured values.
status of the beep function is shown on the display:
– If you feel the measured values are unusually low.
Beep switched on Beep switched off
Make sure that the measuring sensor is always clean. A dirty or
You can now use the MODE button to switch the beep function on clogged measuring sensor can lead to incorrect measurements.
or off.

Switch off the device by pressing the on/off button or wait until the
device switches off automatically after approximately ten seconds.

EN-10 EN-11
Operating the device Operating the device
Measuring the temperature Performing measurement

• Switch on the device by pressing • The best way to perform the measurement on small children is to lie
the on/off button. them flat on their stomach with their head facing to the side so that
the ear is pointing upwards. For older children or adults, it is better
• The display shows “On“ and the to stand slightly behind and to the side of the patient.
display is illuminated in green
(Figure 1). • Pull the ear slightly up/down from the middle to
stretch the ear canal so that you have an unob-
• The device now performs an in- Figure 1 Figure 2 structed view of the eardrum:
ternal self-test and all display
segments will be displayed (Figure 2). – For children aged under one year: Pull the ear
straight back (Figure 6). Figure 6
• The device then switches to measuring mode. A
beep indicates that the device is ready to perform – For children aged one year and over and for
the measurement. The ear icon and the dashes on adults: Pull the ear up and back (Figure 7).
the display start to flash (Figure 3). The LED light
on the measuring tip is illuminated for approxi- • While gently pulling the ear, insert the measuring
mately ten seconds. Figure 3 sensor into the ear canal by applying gentle pres-
sure (Figure 8). Now press the START button Figure 7
Retrieving the last measured value
• Leave the measuring sensor in the ear until the
• Before performing the measurement, you can thermometer emits a beep after approx. one sec-
retrieve the last measured temperature value by ond to indicate the end of the measuring process.
pressing the MEMO button. The last measured The result of the measurement is shown on the
temperature value is shown together with the display (Figure 9). Remove the thermometer from
flashing icon at the bottom of the display (Fig- the ear canal. Figure 8
ure 4). The thermometer then switches back to
Figure 4
measuring mode. • At temperatures between 32.0 °C and 37.5 °C, a
single beep is emitted. The measured tempera-
Retrieving the ambient temperature ture is shown on the display, which is illuminated
in green.
• You also have the option to check the ambient
temperature by pressing the MODE button. The • At temperatures of 37.5 °C to 42.2 °C, three beeps
ambient temperature is shown on the display to- are emitted in quick succession. The measured Figure 9
gether with the icon (Figure 5). The thermome- temperature is shown on the display, which is illu-
ter then switches back to measuring mode. Figure 5 minated in red (fever alarm).
EN-12 EN-13
Operating the device Operating the device
• After approx. ten seconds, the thermometer is ready for the next Measurement results of different measurement types cannot be com-
measurement. The °C icon on the display starts to flash again. pared with each other as the normal body temperature varies de-
pending on where the measurement is taken.
• You can now compare the current measured tem-
perature value with the previous measured value Normal body temperature ranges:
by pressing the MEMO button. The most recent- Axillary (under the arm): 34.7 °C to 37.3 °C
ly measured temperature value is now shown Oral (in the mouth): 35.5 °C to 37.5 °C
in the lower area of the display along with the Rectal (in the anus): 36.6 °C to 38.0 °C
flashing symbol (Figure 10). The thermometer Measured with Domotherm E (in the ear): 35.4 °C to 37.4 °C
then switches back to measuring mode and again
shows the current temperature value. Figure 10 Even the time of day has an effect on body temperature. It is highest
in the evening and lowest approx. one hour before waking up.
• The device switches off automatically approx. 30 seconds after the
last measurement. You can also switch off the device before this by
pressing the on/off button. Extended measuring range
• When the device is switched off, the lighting on The thermometer has an extended measuring range of 0 °C to 100 °C.
the measuring tip flashes and the cleaning icon is This range goes both below and above the medical measuring range
shown on the display (Figure 11) to remind you to of 32.0 °C to 42.2 °C.
clean the measuring sensor. Clean the measuring
tip after each use, following the instructions on As well as measuring body temperature, the thermometer can there-
page 23. fore also be used to measure surface temperatures, e.g. the surface
Figure 11 temperature of the milk in baby bottles, the surface temperature of
the bathing water for infants or the ambient temperature.
Classifying the measured values
The measurement results are shown in different ways on the display:
When classifying a measured value as a fever, you can use the follow-
ing reference values as a guide: The ear icon is shown for measurement results within the medi-
cal measuring range of 32.0 °C to 42.2 °C.
37.5 °C to 38.0 °C: high temperature
38.0 °C to 39.0 °C: moderate fever The crossed-out ear icon is shown for measurement results out-
39.0 °C and above: high fever side the medical measuring range.

Caution: It is essential to consult a doctor in cases of high fever! The relevant icon is saved together with the measured value.

EN-14 EN-15
Operating the device Operating the device
Retrieving saved readings Deleting the measured value memory
The thermometer has a measured value memory that can store 12 • Open any stored measured value.
measured values. The measured values are automatically saved to- • Press and hold the START button for at least five seconds.
gether with the date and time of the measurement. The last meas- • The display first shows CL (Clear), then the memory number 0 (Fig-
ured value is stored in memory location 1, the value measured prior ure 6).
to that is stored in memory location 2, and so on. If more than 12
measurements are taken, the oldest value (no. 12) is deleted so that The device switches off automatically after 30 seconds. You can also
the latest value (no. 1) can be saved. switch off the device before this by pressing the on/off button.

To retrieve the stored measured values, proceed as follows:

Replacing the battery
• With the device switched off, press the MEMO
button. The device switches to memory mode The device is equipped with a CR2032 lithium battery.
(Figure 1)
If the battery icon flashes on the display while the thermometer is
• The most recent measured value no. 1 is now in use, the battery is low. Although you are still able to take tempera-
shown (Figure 2). The measured value is alter- ture measurements, you should have a spare battery ready.
nately shown on the display with the year (Figure
3), month/day (Figure 4) and time (Figure 5). Figure 1 Change the battery if:

– After switching on the device, the “flat battery”

indicator (Figure 1) appears on the display. You
must insert a new battery before you can take
any temperature measurements.

– If nothing is shown on the display despite press- Figure 1

ing the on/off button.
Figure 2 Figure 3 Figure 4 Figure 5
• Press the MEMO button repeatedly to open older To open and close the battery compartment cover,
measurements (no. 2, no. 3, and so on). use the rounded side of the protective cap (see Fig-
ure 2).
If no measured values are saved, the following ap-
pears on the display (Figure 6): • Unlock the cover on the battery compartment and
lift it off. Figure 2

Figure 6
EN-16 EN-17
Operating the device Technical information
• Remove the old battery and in- Error messages
sert a new battery (CR2032) with
the + sign facing up. Measured temperature is above 100.0 °C and is therefore
outside the measuring range.
• Place the cover back on the bat-
tery compartment and lock it in
place. Cover of Cover of
battery battery Measured temperature is below 0 °C and is therefore out-
After replacing the battery, you compartment compartment side the measuring range.
will need to reset the date and time unlocked locked
(see page 9). The saved measured
values and the set unit of measurement (°C/°F) are retained when the
battery is changed. Ambient temperature is above 40.0 °C and is therefore
outside the operating conditions.

Ambient temperature is below 10.0 °C and is therefore

outside the operating conditions.

Electronic fault. If the fault occurs again, contact the UEBE

customer service centre.

Low battery. Have a spare battery ready.

Battery flat. Please replace the battery.

EN-18 EN-19
Technical information Technical information
No display after switching on. Check that the battery is Automatic Approx. 30 seconds after last activity
positioned correctly and the polarity (+/-) is correct. If the switch-off:
error persists, replace the battery. Battery: 1 x CR2032, 3.0 V
Battery life: Approx. 1000 measurements (with a new battery)
IP classification:
IP 22: protected against solid foreign bodies with
a diameter of 12.5 mm and above, protected
Technical data against dripping water.
Type: Domotherm® E ear thermometer Average service Five years or 12,000 measurements
Measuring 0.1 °C to 99.9 °C (32.2 °F to 211.8 °F) life:
range: Dimensions: 145 mm (L) x 38 mm (W) x 36 mm (H)
Measurement 0.1 °C/°F Weight: 54 g with battery, 52 g without battery
resolution:
Measurement ± 0.2 °C between 32.0 °C and 42.2 °C
accuracy in the (± 0.4 °F between 89.6 °F and 108.0 °F) Customer service
laboratory: ± 1 °C (± 2 °F) in other temperature ranges
Display: Liquid crystal display (LCD), four digits plus special Device repairs may only be performed by the manufacturer or an ex-
icons pressly authorised body. Please contact:
Fever alarm: If temperature values above 37.5 °C are meas-
ured, then three short beeps and a red back- UEBE Medical GmbH Tel.: +49 (0) 93 42 / 92 40 40
ground light on the display indicate that this is a Zum Ottersberg 9 Fax: +49 (0) 93 42 / 92 40 80
raised temperature. 97877 Wertheim, Germany Email: [email protected]
Memory: 12 measured values with date and time can be Website: www.uebe.com
opened in memory mode
Metrological inspection
Operating Ambient temperature 10 °C to 40 °C (50 °F to 104
conditions: °F), maximum relative humidity 15 % to 95 %
In accordance with the Medizinprodukte-Betreiberverordnung (Ger-
Conditions for -25 °C to +55 °C (-13 °F to +131 °F), maximum man Medical Device Operator Ordinance), professional users in Ger-
storage and relative humidity 15 % to 95 % many are required to arrange for a metrological inspection to be per-
transport: formed at yearly intervals. Private users are advised to arrange for a
Time to adjust 2 hours technical inspection of the device every two years.
from mini-
mum/maxi- The inspection can be performed either by UEBE Medical GmbH, an
mum storage authority responsible for metrology or an authorised maintenance
temperature service. Please refer to your national regulations.
to operating
temperature:
EN-20 EN-21
Technical information Cleaning and care
Upon request, responsible authorities or authorised maintenance ser- • The measuring tip must be cleaned after each use! Any contami-
vices will receive a “test instruction for metrological inspection“ from nation of the measuring tip will cause malfunctions and inaccurate
the manufacturer. measurements.

• Use one of the enclosed alcohol wipes or a cotton cloth or cotton

Explanation of symbols bud moistened with alcohol (70 % isopropyl alcohol) to clean the
housing and the measuring probe.
This product complies with Council Directive 93/42/EEC of
5 September 2007 concerning medical devices and bears • Make sure that no liquid enters into the thermometer itself.
0123 the mark CE 0123 (TÜV SÜD Product Service GmbH).
• Do not use aggressive cleaning agents, solvents or benzene for
Degree of protection against electric shock: TYPE BF cleaning purposes. Never immerse the device in water or other
cleaning fluids.
Consult the instructions for use
• Make sure that the surface of the measuring sensor and the display
55 °C
Conditions for storage and transport do not become scratched.
-25 °C
95 % Ambient temperature -25 °C to +55 °C
15 %
Maximum relative humidity 15 % to 95 % • After cleaning the measuring sensor with alcohol, wait five min-
utes before taking the next temperature measurement. This will
Manufacturer ensure that the thermometer can return to the required operating
temperature.
IP 22 Protected against solid foreign bodies with a diameter of
12.5 mm and above, protection against dripping water.

Device serial number

Reference number = item number

Disposal
Technical equipment and batteries do not belong in
household waste. They must be disposed of at appropriate
collection and disposal points.

EN-22 EN-23
Warranty
The device has been manufactured and tested with all due care. Nev-
ertheless, in the event of defects upon delivery, we provide a warran-
ty under the following conditions:

During the warranty period of 2 years from the date of purchase, we

remedy such defects at our discretion and at our expense in our plant
through repair work or replacement delivery of a defect-free device.

The warranty does not cover normal wear and tear of wearing parts
or damage caused by failure to observe the instructions for use, im-
proper handling (e.g. unsuitable power sources, breakage, leaking
batteries) and/or disassembly of the device by the buyer. Further-
more, the warranty does not constitute grounds for asserting claims
for damages against us.

Warranty claims can only be asserted during the warranty period and
upon presentation of the proof of purchase. In the case of a warranty
claim, the device along with the proof of purchase and a description
of the complaint must be sent to:

UEBE Medical GmbH

Service-Center
Zum Schlag 18
97877 Wertheim
Germany

The cost of returning the device to our factory shall be borne by the
sender. Complaints that are sent back without prepayment will not be
accepted by UEBE.

The statutory claims and rights of the buyer against the seller (for
example, defect claims, producer liability) are not restricted by this
warranty.

Please note: In the case of a warranty claim, please make sure to

enclose the proof of purchase.

EN-24
 0875

PZN-11613786

Domotherm und UEBE are internationally protected trademarks of:

UEBE Medical GmbH

Zum Ottersberg 9
97877 Wertheim, Germany
Phone: +49 (0) 93 42 / 92 40 40
Fax: +49 (0) 93 42 / 92 40 80
Email: [email protected]
Website: www.uebe.com

7 0875 201 DA

Subject to technical modifications.

2019-07

Reprinting, including of extracts, is prohibited.

© Copyright 2019 UEBE Medical GmbH

0123