Avita TS12 User manual

Infrared Forehead Thermometer
TS12
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 on the Forehead................................................. 6
Memory Function ............................................................................................................. 7
Cleaning and Disinfecting............................................................................................. 7
Error Codes.......................................................................................................................... 9
Technical Specification .................................................................................................10
EMC Tables.........................................................................................................................11
Explanation of Symbols................................................................................................13

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 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
A
Sensor Tip with Lens
B
Memory Button
C
Battery Cover
D
Power/ Measure Button
E
LCD Display

5
Description of LCD Display
1 Memory symbol
2 Smiling face
Measurement<38°C(< 100.4°F)
3 Frowning face
Measurement≥38°C(≥100.4°F)
4 Low battery Warning
5 Scan in Progress
6 Fahrenheit Scale
7 Celsius Scale
8 Degrees of Temperature

6
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.

7
Memory Function
1. The device can recall up to 10 measurements
2. Press the “Memory Recall” button. The first reading displayed is
the latest measurement stored in memory.
3. Continue to press the “Memory Button” to view the next
previously stored measurement.
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.

8
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 1 x 3V CR2032 battery 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.

9
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.

10
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: 1 x 3V CR2032
•Auto switch-off in 60 seconds without operation
•Memory: 10 sets
•Weight : approx. 45g (with batteries)
•Dimensions :
approx. 34 x 117 x 29 mm (W x H x D)
•Typical Service Life：3 years
•Battery Shelf Life：5 years
•Battery Operation Time: About 90 minutes (Depends on different
brand of batteries.)

11
EMC Tables
TS12 is intended for use in the electromagnetic environment specified
below. The customer or the user of TS12 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 TS12 can be

12
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.

13
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

14
Humidity limitation
Atmospheric pressure limitation
Caution
Consult the instruction for use
Disposal information: Should you wish to dispose of the
article, do so in accordance with current regulations. Details
are available from your local authority. WEEE 2012/19/EU
Directives
RoHS
This product fulfilling the requirements of the RoHS
Directive 2011/65/EU.
REACH
This product fulfilling the requirements of the REACH
Directive EC 1907/2006 and its amendments, do not
contain Substances of Very High Concern in concentration
above the limit of 0.1 %. No substance(s) is/are present in
the parts of the product above the concentration of 0.1 %
weight by weight.
Stand-by
Device classification type BF

15
This product meets the basic safety and essential
performance requirements indicated in the IP22
conditioning test (protection against solid foreign objects of
12.5mm ∅and greater and against vertically falling water
drops when enclosure tiled up to 15°)
The empty, completely flat batteries must be disposed of
through specially designated collection boxes, recycling
points or electronics retailers. You are legally required to
dispose of the batteries.
Importer
Distributor
Model Number
Country of Manufacturer
Unique Device Identifier
TS12P-22105AV
2022.04.22