Avita TS21 User manual

Infrared Ear Thermometer
TS21
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, China
China, AViTA(WUJIANG)
Importer
Distributor
INSTRUCTION MANUAL
Please read this instruction manual carefully
before using your Infrared thermometer

Contents
Introduction ........................................................................................................................ 1
Important Information before Use ........................................................................... 2
Product Identification ..................................................................................................... 4
Description of LCD Display........................................................................................... 5
Battery Installation ........................................................................................................... 6
Setting °C/°F........................................................................................................................ 7
Memory Function ............................................................................................................. 7
Measuring Body Temperature in the Ear................................................................ 8
Cleaning and Disinfecting............................................................................................. 9
Error Codes........................................................................................................................10
Trouble Shootings ..........................................................................................................11
Technical Specification .................................................................................................13
EMC Tables.........................................................................................................................14
Explanation of Symbols................................................................................................16

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.
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.
Contraindication:
1. The ear is infected with otitis or suppuration.
2. The ear canal treated with ear drops or other medications.
3. Blood or drainage in ear canal.
4. Face and/or ear deformities

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. The thermometer is calibrated at the time of manufacture. If at any

3
time you question the accuracy of temperature measurements, please
contact an authorized distributor for sending calibration services,
additional cost may apply for return shipping fee.
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 you would require any assistance during setting up, using or
maintaining, please contact the manufacturer.
19. Avoid usin9g the device near an operating cell phone or microwave
oven.
20. 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.
21. Neonatal under 6 months, the ear canal is still under development,
very narrow so the temperature of the eardrum often cannot be
recorded and the result displayed is often too low.
22. Make sure the ear canal is clean not blocked by earwax.

4
Product Identification
1
Probe
2
Power/ Measurement Button
3
LCD Display
4
Memory Button
5
Battery door

5
Description of LCD Display
Measurement in progress
Temperatuer unit Celcius
Temperatuer unit Fahrenheit
Degree of temperature
Low battery symbol
Memory symbol and sets of records
Smiling Face
Frowning Face

6
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.

7
Setting °C/°F
Changing the Measurement Unit (°C/°F)
1. Press the “Power & Measure Button” to turn on the unit.
2. If you wish to change the temperature scale of your thermometer,
turn your thermometer on and then press the “Power & Measure
Button” and “Memory Button” to switch the unit..
Memory Function
Memory Recall:
You can recall up to 9 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.
2. Press the “Memory” button. The last measured value will appear on
the display.
Memory Deletion:
Remove batteries, memory will be cleared.
NOTE:
All the readings will be cleared no matter record in Human Mode or
Object Mode.

8
Measuring Body Temperature in the Ear
1. 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. Then wait for beep sound to
let you know the appliance is ready and followed by last
temperature reading.
2. 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.
3. Insert the sensor tip carefully and press the Power button for 1
second.
4. The end of the measuring time is signaled with beep sound and the
measured value appears on the display.

9
Cleaning and Disinfecting
For home use device disinfection, 75% alcohol (available in the
pharmacy) can be used.
•Probe and Tip
Clean the probe and tip 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.

10
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.

11
Trouble Shootings
Trouble
Probable Case
Recommended Action
Failed to power
on.
Batteries are drained.
Replace with a new
battery
Batteries are not
correctly aligned with
terminals.
Reinsert batteries
correctly.
The thermometer is
damaged.
Contact your retailer or
Customer Services.
Low battery
symbol appears.
Low battery.
Replace with a new
battery as soon as
practical
In colder temperature
batteries have weaker
electrical charges.
Warm up the batteries
or use the device in a
warmer setting.
The
measurement is
abnormal or if
there is any
doubt on the
measured result
Incorrect measure
position.
Reposition the probe
point the eardrum.
The measuring is
hampered by earwax
Remove obstructions
from ear.
The lens of probe is
dirty.
Clean the lens
according to cleaning
and disinfecting .
You have just come
from extreme
temperatures
environment.
Stay in steady state
room at least for 30
minutes.
The thermometer has
been stored in a cold
room or exposed to
direct sunlight.
Put the thermometer in
steady state room at
least for 30 minutes.
Power switches
off automatically.
System design.
Push the power button
again.

12
Trouble
Probable Case
Recommended Action
Batteries are drained.
Replace with a new
battery
The thermometer is
damaged.
Contact your retailer or
Customer Services.

13
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)
•Operating environment :
15°C –40°C (59°F –104°F)
with relative humidity 15% to 95% (non-condensing)
Atmospheric Pressure: 700~1060 hPa
•Storage/ Transportation environment :
-25°C –55°C (-13°F ~+131°F)
with relative humidity 15% 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 (without batteries)
•Dimensions : approx. 108.6 x 30.2 x 42.1 mm (L×W×H)
•Shelf Life：3 years
•Battery Operation Time: About 90 minutes (Depends on different
brand of batteries.)
•For Customer Service
To obtain further service please contact AViTA Corp. for the address of the repair
location. Enclose the Proof of Purchase. Include $10.00 USD for the return shipping
and handling. Include a letter, with your name, address, phone number, and
description of the specific problem. Pack the product carefully to prevent damage in
transit. Because of possible loss in transit, we recommend insuring the product with
return receipt requested.

14
EMC Tables
TS21 is intended for use in the electromagnetic environment specified
below. The customer or the user of TS21 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
CISPR 11
Group 1 Class A (Not BLE
Function)
Group 2 Class A (With
BLE Function)
CISPR 11
Group 1 Class B (Not
BLE Function)
Group 2 Class B (With
BLE Function)
Harmonic distortion
Not applicable
(Note: Power by Battery or DC Input)
Only the AC input needs to be tested
Voltage fluctuations
and flickering
Not applicable
(Note: Power by Battery or DC Input)
Only the AC input needs to be tested
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

15
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 TS21 can be
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.

16
Explanation of Symbols
The CE marking with the Registration Number of the
Notified Body. This denotes the compliance of
Regulation (EU) 2017/745
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

17
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

18
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
Keep away from sunlight
Electronic IFU available at http://www.avita.com.tw
TS21P-22676AV
2022.12.22