Avita TS46 User manual

Infrared Ear/ Forehead Thermometer
TS46
EN
RoHS REACH
MDSS GmbH
Schiffgraben 41
30175 Hannover Germany
AViTA Corporation
9F., No. 78, Sec. 1, Kwang Fu Rd.,
San Chung Dist., New Taipei City 24158, Taiwan
Importer
Distributor
INSTRUCTION MANUAL
Please read this instruction manual carefully
before using your forehead thermometer

Contents
Introduction ........................................................................................................................ 1
Important Information before Use ........................................................................... 2
Product Identification ..................................................................................................... 4
Description of LCD Display........................................................................................... 5
Measuring Body Temperature in the Ear................................................................ 6
Measuring Body Temperature on the Forehead................................................. 7
Measuring Object/Liquid Temperature .................................................................. 8
Setting °C/°F and Date/Time....................................................................................... 9
LED Flashlight ...................................................................................................................10
Memory Function ...........................................................................................................11
Cleaning and Disinfecting...........................................................................................13
Error Codes........................................................................................................................14
Technical Specification .................................................................................................15
EMC Tables.........................................................................................................................16
Explanation of Symbols................................................................................................18

1
Introduction
Intended Use
This thermometer is intended for home use and the measurement of
human body temperature in people of all ages. This thermometer takes
temperatures in seconds by measuring the heat generated by the ear
canal/ on the forehead.
Type of Use/ Reuse
Multiple patient multiple use
Intended User
The Patient is an intended operator.
Patient selection criteria: Handicapped persons and children are the
exception of handicapped persons and children need assistance by
another person to use the device.

2
Important Information before Use
When using this product, please be sure to follow all the notes listed below. Any action
against these notices may cause injury or affect the accuracy.
1. Do not disassemble, repair, or remodel the thermometer.
2. Be sure to clean the thermometer lens each time after usage.
3. Avoid direct finger contact with the lens.
4. WARNING: No modification of this equipment is allowed.
5. It is recommended that user may take 3 temperatures. If they are different, use the
highest reading.
6. Do not expose the thermometer to extreme temperature, very high humidity, or direct
sunlight.
7. Avoid extreme shock or dropping the device.
8. Before the measurement, patients and thermometer should stay in steady state room
condition for at least 30 minutes.
9. Avoid measuring temperature in 30 minutes after exercise, bathing, or returning from
outdoor.
10. To protect the environment, dispose of empty batteries at appropriate collection sites
according to national or local regulations.
11. Please use the thermometer solely for its intended purpose.
12. There are no absolute body temperature standards. Keep reliable records of your
personal temperature to serve as a reference for judging a fever.
13. Under any circumstances, the temperature taking result is ONLY for reference.
Before taking any medical action, please consult your physician.
14. It is recommended calibrate the device every 1 year.
15. CAUTION - Avoid potential allergic reactions, please avoid the front of
scanner in direct contact to patient's wound.
16. CAUTION - Please keep this device away from pets, pests, and children.
17. CAUTION: Please keep away from children and pets, because small parts
may be inhaled or swallowed.
18. If any serious incident that has occurred in relation to the device should be reported
to the manufacturer and the competent authority of the Member State in which the user
is established.

3
19. If you would require any assistance during setting up, using or maintaining, please
contact the manufacturer.
20. Avoid using the device near an operating cell phone or microwave oven.

4
Product Identification
1
Forehead/Cover Cap
2
Power/Ear Measure button
3
Memory button
4
Probe
5
LCD Display
6
LED Flashlight
7
SET button
8
Forehead Measure button
9
Battery Compartment Lid

5
Description of LCD Display
1
Date
2
Time
3
Measurement in progress
4
Temperatuer unit
5
Temperatuer unit
6
Degree of temperature
7
Sound symbol
8
Low battery symbol
9
Memory symbol and sets of records
10
Object measurement
11
Ear measurement
12
Forehead measurement

6
Measuring Body Temperature in the Ear
1. Remove the front cover.
2. Press the Power/Measure button for 1 second to switch the
thermometer on. All screen data will display on screen. Then the
measurement mode flashes on screen. If the icon shows forehead
mode, please press Power/Measure button again to change to ear
mode. Then wait for 2 beep sounds to let you know the appliance is
ready and followed by last temperature reading.
3. Make sure that the sensor tip and also the ear canal are clean. As
the ear canal is slightly curved, you have to pull the ear slightly up
and backwards before inserting the sensor tip. This is important so
that the sensor tip can be pointed directly at the eardrum.
4. Insert the sensor tip carefully and press the Power button for 1
second.
5. The end of the measuring time is signaled with beep sound and the
measured value appears on the display.

7
Measuring Body Temperature on the Forehead
1. The cap should be in position on the probe nozzle.
2. Press the Power/Measure button. All screen data will display on
screen. Then the measurement mode flashes on screen. If the icon
shows ear mode, please press the Power/Measure button again to
change to forehead mode. Then wait for 2 beep sounds to let you
know the appliance is ready and followed by last temperature
reading.
3. When the beep sounds to let you know the appliance is ready, press
the Power/Measure button and maintain pressure.
4. Place the probe on your temple. Slide the probe across your
forehead to the other temple, and then release pressure on button
to stop temperature taking. You’ll hear a beep and your
temperature will come up on the screen.
Note: Forehead temperature may be affected by external climatic
conditions. If in doubt, do not hesitate to take your ear
temperature.

8
Measuring Object/Liquid Temperature
1. Press the Power button for 1 second to switch the thermometer on.
Following a successful self-test, the device emits two short beeps.
2. Then press the “Memory” and “SET” buttons simultaneously
for 3 seconds to switch to the object measurement mode.
3. Point the sensor tip towards the object or liquid (maintaining a
distance of 3 cm), then take one press on “Forehead Measurement”
button or “Ear Measurement” button to take a measurement
(never immerse in liquids).
4. After the measurement process is complete, there comes a short
beep and the measured value appears on the display.
5. Please note that the displayed temperature is the measured and
not the adapted surface temperature. It is not the same as the
temperature.
6. To switch to the other thermometer mode, press the “Memory”
and “SET” buttons simultaneously for 3 seconds.

9
Setting °C/°F and Date/Time
When the thermometer is used for the first time and each time the
batteries are changed, the date and time are displayed in the format “1
- 1 00:00”during the basic set-up (after the self-test). Set each of the
following settings in turns: nit in which the temperature will be
displayed, date and time. To set the device, proceed in stages:
Unit –year –month –day –hours –minutes
After installs batteries (first time to use). The device performs a brief
self-test: all elements of the display are shown for approx. 1 second.
Following a successful self-test, the device emits two short beeps. In
Standby mode, the date and time are shown and
“--” is displayed.
Enter into Setting Under power-on condition, press "Set" button for
5 seconds to enter into setting mode.
°C / °F When the unit blinking, press the “SET” button
to change the unit. Press the “Memory” button
can save and confirm the unit, then goes to next
setting.
Year When the year Icon blinking, press the “SET”
button to change the number. Press the
“Memory” button can save and confirm the
year, then goes to next setting.
Month When the month Icon blinking, press the “SET”
button to change the number. Press the
“Memory” button can save and confirm the
month, then goes to next setting.
Day When the day con blinking, press the “SET”
button to change the number. Press the
“Memory” button can save and confirm the day
then goes to next setting.

10
Hour When the hour Icon blinking, press the “SET”
button to change the number. Press the
“Memory” button can save and confirm the
hour, then goes to next setting.
Minute When the minute Icon blinking, press the “SET”
button to change the number. Press the
“Memory” button can save and confirm the
minute, then goes to end the setting loop.
End setting loop the display shows OFF and switches off
automatically.
LED Flashlight
1. When the device is on, press and hold the “Memory” button for 3
seconds, and the flashlight will turn ON.
2. Flashlight will automatically shut off after a few seconds, or press
any button to shut off it.
NOTE:
The LED flashlight is a built-in and can be used for discreet nighttime
use.

11
Memory Function
Memory Recall:
You can recall up to 30 measurements currently stored in memory to
share with your physician or trained healthcare professional.
1. When the device is on, press once briefly on the Memory Button,
then pass it again to show the last measurement accompanied by
“ ” symbol.
2. The mode symbol will appear with each measurement stored in
memory to indicate whether a person or object temperature was
taken.
3. Each press of the same button recalls a previous measurement.
Memory Deletion:
Remove batteries, memory will be cleared.
NOTE:
All the readings will be cleared no matter record in Human Mode or
Object Mode.

12
Battery Installation
When the batteries get weak, the battery warning symbol appears
. It is still possible to measure temperature. The batteries must be
replaced. When the battery symbol flashes and “Lo” appears
in the display, the batteries must be replaced. If the batteries are too flat,
then the thermometer will switch off automatically.
NOTE:
• It is recommended to remove the batteries if the unit will not be used
for an extended period of time.
•Please properly dispose of the batteries away from small children and
heat.
•Batteries must be disposed of in accordance with local environmental
and institutional policies.
•Do not use rechargeable batteries.
1. Open the battery case by sliding off the cover on the back of the unit.
2. Remove used battery.
3. Replace with 2 x 1.5V LR03(AAA) alkaline batteries in designated area.
The larger part of the battery should be facing up. You should still be
able to see the "+" sign when battery is installed.
4. Slide the cover back on. Unit is ready for immediate use
Dispose of used batteries in accordance with the applicable legal
regulations. Never dispose of batteries in the normal household waste.

13
Cleaning and Disinfecting
For home use device disinfection, 75% Ethanol Isopropyl alcohol
(available in the pharmacy) can be used.
• Probe and Tip
Clean the probe and tip with an75% Ethanol or Isopropyl alcohol before
and after each measurement.
• Thermometer:
Use a soft, dry cloth to clean thermometer body. Never use abrasive
cleaning agents, thinners or benzene for cleaning. Do not scratch the
surface of the probe lens or the display. Do not expose the
thermometer to extreme temperatures, humidity, direct sunlight, or
shock.

14
Error Codes
When a malfunction or incorrect temperature measurement occurs, an
error message will appear as described below.
LCD Display
Cause
Solution
The temperature measured
is higher than
43°C (109.4°F)
Operate the
thermometer only
between the specified
temperature ranges. If
necessary, clean the
sensor tip. In the event
of a repeated error
message, contact your
retailer or Customer
Services.
The temperature
measured is lower than
34°C (93.2°F)
The operating temperature
is not in the range
15°C~40°C (59°F~104°F)
Operate the
thermometer only
between the specified
temperature ranges.

15
Technical Specification
•Range of Measurement :
Human Body: 34°C –43°C (93.2°F –109.4°F)
•Measuring accuracy :
Human Body: 34°C –43°C (93.2°F –109.4°F) ±0.2°C (0.4°F)
Out of range ±0.3°C (0.5°F)
•Operating environment :
15°C –40°C (59°F –104°F)
with relative humidity up to 95% (non-condensing)
Atmospheric Pressure: 700~1060 hPa
•Storage/ Transportation environment :
-25°C –55°C (-13°F ~+131°F)
with relative humidity up to 95% (non-condensing)
Atmospheric Pressure: 700~1060 hPa
•Display resolution : 0.1°C
•Power supply: 2 x 1.5V LR03(AAA) alkaline
•Auto switch-off in 60 seconds without operation
•Memory: 30 sets
•Weight : approx. 60 g(without battery)
•Dimensions :
approx. 131.4 ×37.3 x 40.4 mm
•Typical Service Life：3 years
•Battery Shelf Life：5 years
•Battery Operation Time: About 90 minutes (Depends on different
brand of batteries.)

16
EMC Tables
TS46 is intended for use in the electromagnetic environment specified
below. The customer or the user of TS46 must make sure that it is used
in such an environment.
Guidance and manufacturer’s declaration - Electromagnetic emissions
Phenomenon
Professional healthcare
facility environment a)
HOME HEALTHCARE
ENVIRONMENT a)
Conducted and
radiated RF MISSIONS
a)
CISPR 11
Group 1 Class B
Harmonic distortion
Not applicable
Voltage fluctuations
and flickering
Not applicable
a) The equipment is suitable for use in Home Health Environments and
Professional Health Care Environments limited to patient rooms and
respiratory treatment facilities in hospital or clinics. The more restrictive
acceptance limits of Group 1 Class B (CISPR 11) have been considered
and applied. The equipment is suitable for use in the mentioned
environments when directly connected to the Public Mains Network.
b) The test is not applicable in this environment unless the ME
EQUIPMENT and ME SYSTEM used will be connected to the PUBLIC
MAINS NETWORK and the power input is otherwise within the scope of
the Basic EMC standard.
Guidance and manufacturer’s declaration - Electromagnetic immunity
- Enclosure port
Phenomenon
Basic EMC
standard or
test method
Immunity test levels
Professional
healthcare
facility
environment
HOME HEALTHCARE
ENVIRONMENT
ELECTROSTATIC
DISCHARGE
IEC 61000-4-2
±8kV contact
±2 kV, ±4kV ±, ±8 kV, ±15 kV air
Radiated RF EM
fields
IEC 61000-4-3
a)
10 V/m b) 80MHz - 2.7
GHz 80% AM at 1kHz
Proximity fields
from RF wireless
communications
equipment
IEC 61000-4-3
COMPLIANT
NOTE: Further information about
distances to be maintained between
portable and mobile RF
communications equipment
(transmitters) and the TS46 can be

17
requested from supplier using the
contact information provided in this
manual. However, it is advisable to
keep the electromechanical aerosol
equipment at an adequate distance
of, at least, 0.5 m from mobile phones
or other RF communications
transmitters to minimise possible
interference.
RATED power
frequency
magnetic fields.
IEC 61000-4-8
30 A/m c)
50 Hz or 60 Hz
a) The equipment is suitable for use in Home Health Environments and
Professional Health Care Environments limited to patient rooms and
respiratory treatment facilities in hospital or clinics. The more restrictive
IMMUNITY acceptance limits have been considered and applied.
b) Before modulation is applied.
c) This test level assumes a minimum distance of at least 15 cm between
the ME EQUIPMENT or ME SYSTEM and sources of power frequency
magnetic fields.

18
Explanation of Symbols
The CE marking with the Registration Number of the
Notified Body. This denotes the compliance of European
Medical Device Directive 93/42/EEC
Medical Device
Manufacturer
Authorized representative in the European Community
Date of manufacture
(YYYY-MM-DD or YYYY-MM)
Batch code
(YYMMWWWW)
Serial number
(YYMWWWXXXXX)
Keep dry
Temperature limit