FOR-A IR21 User manual

Ear/Forehead Thermometer /
Ohr-/Stirnthermometer /
Thermomètre Auriculaire/Frontal /
Termometro Auricolare/Frontale /
Termómetro de frente y oído /
Termómetro de Ouvido/Testa
Ear Thermometer /
Ohrthermometer /
Thermomètre Auriculaire /
Termometro Auricolare /
Termómetro de oído /
Termómetro de Ouvido
Owner’s Manual / Benutzerhandbuch /
Manuel de l’utilisateur / Manuale del Proprietario /
Manual de instrucciones / Manual de instruções
IR21 / IR20

EN-1
IMPORTANT
SAFETY
INSTRUCTIONS
English
311-1261000-084 202109 Ver 3.0
READ THIS BEFORE USING
The following basic safety precautions
should always be taken.
1. Close supervision is necessary when the thermometer
is used by, on, or near children, handicapped persons
or invalids.
2. Use the thermometer only for the intended use
described in this manual.
3. Do not use the thermometer if it is not working
properly, or if it has su󰀨ered any damage.
4. Do not use accessories which are not supplied or
recommended by the manufacturer.
KEEP THESE INSTRUCTIONS IN A SAFE PLACE
Cautions and Warnings
As with any thermometer, proper technique is crucial
to getting accurate temperature readings. Please read
this manual thoroughly and carefully before using.
Always store the thermometer in a cool and dry place:
temperatures between -20°C to 60°C (-4°F to 140°F)
relative humidity less than 95%. Avoid direct sunlight.
Avoid dropping the thermometer from a height or
strongly hitting it with a hard object.
Do not touch the probe lens.
Do not disassemble the thermometer.
Basic safety precautions should always be observed,
especially when the thermometer is used on or near
children and disabled persons.
This thermometer is not intended to be a substitution for
consultation with your physician.
The skin/surface scan temperature serves as a
reference only. It cannot be a judgment on fever.
Temperature of left and right ear may di󰀨er. Always
measure using same ear.

EN-2
Only use the probe cover for infrared FORA IR20 ear
thermometer.
For proper hygiene, do not share probe cover.
Damaged probe cover may result in error display.
If you experience any serious incident that occurred
in relation to the use of this product, please report it
to the manufacturer and the competent authority of
medical devices in your country.
A serious incident means any incident that directly or
indirectly led, might have led, or might lead to any of
the following:
(a) the death of a patient, user, or other people,
(b) the temporary or permanent serious deterioration of
a patient's, user's or other person's state of health,
(c) a serious public health threat.
Restrictions of Use
This thermometer is clinically proven to produce
accurate temperature measurements. However, please
be advised if you have the following situations:
The accuracy cannot be ensured for a person who has
deformity in the ear such that the thermometer probe
can not be properly inserted into the ear canal.
The accuracy cannot be ensured when blood or
drainage is found in the ear canal.
Take temperature from the other ear if ear drops or
medications have been placed in an ear.
For a person who wears ear plug or hearing aid,
remove the device and wait for 15 minutes before
taking temperature.
NOTE
Never try to clean inside the ears. You may accidentally damage
the eardrum or its surrounding tissues. Remove excess earwax
only when you can reach it with a clean cloth. Consult a physician
if you suspect the presence of excess earwax.
Introduction
Thank you for choosing FORA IR21 ear/forehead
thermometer. This innovative medical device relies
on advanced infrared (IR) technology to measure
temperature instantly and accurately through two
convenient sites: the ear canal and the surface of
the skin over the temple. FORA IR21 ear/forehead
thermometer is an elegantly designed infrared
thermometer meant for your family.

EN-3
Thank you for choosing FORA IR20 ear thermometer.
This innovative medical device relies on on advanced
infrared (IR) technology to measure temperature
instantly FORA IR20 ear thermometer is an elegantly
designed infrared thermometer meant for your family.
Intended use
FORA IR21 ear/forehead thermometer is intended for
the intermittent measurement and monitoring of human
body temperature from ear canal or skin/surface scan.
The device is intended for use by people of all ages in
the home.
FORA IR20 ear thermometer is intended for the
intermittent measurement and monitoring of human
body temperature from ear canal. The device is intended
for use by people of all ages in the home.
How does it work
The thermometer measures the infrared heat generated
by the eardrum and its surrounding tissue, or by the
surface of the skin over the temporal artery. The
thermometer then converts it into a temperature value
shown on LCD.
NOTE
The thermometer does not emit any infrared signal.
Thermometer
Parts
1
2
3
4
6
7
8
9
10
5
Probe cover
Night light (FORA IR21) /
Probe cover ejection button
(FORA IR20)
On/Memory button
Sticker
Battery cover
Data port
Probe lens
Probe
Scan button
Probe cover detector
(FORA IR20)
1
10
2
3
4
6
7
8
9
5
1
2
3
4
6
7
8
9
5

EN-4
LCD Screen
1
2
3
4
6
7
8
9
10
5
Ear temperature
indicator
Skin/Surface
temperature indicator
Temperature scanning
in progress
Temperature display
Memory mode
Record numbers
Low bettery indicator
Temperature unit
Communication symbol
Non-probe cover
warning (FORA IR20)
Step 1
Remove the battery cover.
Step 2
Place the new battery in the
battery compartment and press
it in until the battery is rmly secured.
Replacing the Battery
The thermometer comes with two 1.5V AAA alkaline
batteries. Replace it when “ ” appears. Please follow
the steps to replace new batteries.
7
6
3
5
4
8
12 9
7
6
3
5
4
8
12 9
10

EN-5
Step 3
Reattach the battery cover.
NOTE
Although the thermometer works when “ ” appears, we still
recommend that you change the battery to obtain an accurate
result.
Remove the battery if stored for a long period of time.
The battery should be kept out of reach of children. If they are
swallowed, promptly see a doctor for help.
About Normal Body
Temperature & Fever
Body temperature can vary from one individual/person to
next. It also varies by location on the body and di󰀨erent
time of the day. Below shows the statistical normal
ranges from di󰀨erent sites. Please keep in mind that
temperatures measured from di󰀨erent sites, even at the
same time, should not be directly compared.
Table 1*1 Body Site Normal Temperature Range
Oral 0.6°C (1°F) or more above or below 37°C (98.6°F)
Rectal/ear 0.3°C to 0.6°C (0.5°F to 1°F) higher than oral temperature
Axillary
(underarm) 0.3°C to 0.6°C (0.5°F to 1°F) lower than oral temperature
*1. Body Temperature at WebMD;
http://rstaid.webmd.com/body-temperature retrieved at 2010 Jan 7.
Using the Device
As an Ear Thermometer (IR21)
Fever indicates that the body temperature is higher
than normal. This symptom may be potentially caused
by infection, overdressing or immunization. Some
people may not experience fever even when they
are ill. These include, but are not limited to, infants
younger than 3 months old, persons with compromised
immune systems, persons taking antibiotics, steroids
or antipyretics (aspirin, ibuprofen, acetaminophen), or
persons with certain chronic illnesses. Please consult
your physician when you feel ill even if you do not
have fever.

EN-6
Step 2
Turn on the thermometer.
Press and release the On / Memory
button. When ready, the thermometer
displays the last measurement.
Step 1
Remove the probe cover rst.
Step 3
Gently t the probe into the ear
canal.
Step 4
Press and release the Scan
button.
Do not remove the thermometer
until it beeps.
Step 5
Read the result.
“ ” is shown together with a
temperature value.
NOTE
The thermometer does not require any costly lens lters.
Turn o the thermometer by pressing On / Memory button twice.
It will automatically turn o if left idle for 3 minutes.
If you need to take another reading, wait “ ” ashing before
taking another measurement.

EN-7
NOTE
If a probe cover is not attached on the probe, LCD will show “
” until a new probe cover is rmly attached to the probe.
The used probe cover should be removed after each
measurement by a clean and new probe cover to ensure
accuracy reading.
For hygiene use, attach a new probe cover each time and do
not touch its tip.
Hints on Taking Ear Temperture
As with other of thermometer, you may observe
slight variations in consecutive measurements. It is
recommended that you take 3 temperature readings
and use the highest one for the following situations:
Infants younger than 3 months old.
Children younger than 3 years old and who have a
compromised immune system and the presence /
absence of fever is critical.
When you are learning to use the thermometer.
Do not take a reading while eating and /or talking.
Wait 30 minutes after any of the following situations
before taking a measurement:
When you have your ear covered.
After exercising, swimming, or taking a bath. When
expose to extreme temperature.
To take accurate readings, the ear must be free from
excess earwax build-up.
Replacing Probe Cover (IR20)
Step 1
Check the probe cover is clean and
new.
Step 2
Attach new probe cover into the
probe.
Now, you can start to test your
ear temperature.

EN-8
NOTE
Turn o the thermometer by pressing On / Memory button twice.
It will automatically turn o if left idle for 3 minutes.
Taking Ear Temperature (IR20)
Step 1
Make sure probe cover is rmly
attached to the probe.
Step 2
Press and release the On / Memory
button to turn on the thermometer.
When ready, the thermometer
displays the last measurement.
Step 4
Press and release the Scan button.
Do not remove the thermometer
until it beeps.
Step 5
Read the result.
“ ” is shown together with a
temperature value.
Step 3
Stretch your ear canal by pulling
your ear backwards and upwards
and carefully insert the thermometer
into the ear.
Step 6
Discard used probe cover into trash
by pressing probe cover ejection
button.

EN-9
As a Skin/Surface Scan
Thermometer (IR21)
Step 1
Make sure the probe cover is capped.
Step 2
Turn on the thermometer.
Press and release the On / Memory
button. The thermometer displays
the last measurement.
Step 3
Put the probe on the temple.
Press and hold the Scan button.
Make sure the probe is at on the
temple, not at an angle.
Step 4
Read the result.
Release the button and read the
result. “ ” is shown together with a
temperature value and beeps.
NOTE
As the skin/surface scan temperature is likely to be aected by
sweat, oil and the surroundings, the reading shall be taken as a
reference only.
If the probe is placed at an angle on the skin/surface scan, the
reading will be aected by surrounding temperature.
You can perform a skin/surface scan from 3 cm away.
Turn o the thermometer by pressing On / Memory button twice.
Or leave for 3 minutes after a temperature measurement, the
thermometer will automatically turn o.
If you need to take another reading, for the ashing “ ”
ashing before taking another measurement.

EN-10
Recalling the Memory
Your thermometer stores 10 recent readings in the
memory.
Step 1
Be sure the
thermometer is OFF
before recalling this
memory.
Step 2
Press the On /
Memory button
to turn on the
thermometer.
Step 3
Press the On /
Memory button for
3 seconds to enter
memory mode.
Each time you press the On / Memory button, a result will
be displayed in the order of dates (latest result shown
rst), together with “ ” and number ( from 1 to 10 ).
When the memory is full, the oldest result is deleted as
the new one added. When the last record is displayed in
the LCD, press On / Memory button again to return the
rst record.
Step 4
Exit the memory.
Press the Scan button and LCD will show latest results
with ashing “ ” . Then press On/Memory button
again and LCD will show “ OFF ” to exit memory.
NOTE
When using the thermometer for the rst time, the rst memory
result will display 0.0°C. It indicates that there are no test results
in memory.
Viewing Results on a
Personal Computer
Results in memory can be transmitted to the personal
computer by either cable or wireless connection

EN-11
for FORA IR21c / IR20c and FORA IR21b / IR20b,
respectively. Accessories needed to activate this
function are:
Health Care Software System: a software downloaded
from ForaCare’s website (www.foracare.ch)
Interface Cable: an optional accessory for FORA
IR21c / IR20c.
Bluetooth Adapter: an optional accessory for FORA
IR21b / IR20b.
Please contact your local customer service for above
accessories.
Transmitting data via Cable
(FORA IR21c / IR20c)
Step 1 Install Software
Install Health Care System Software on your computer
by following the instructions provides on ForaCare’s
website.
Step 2 Connect to Personal Computer
Connect the interface cable to a serial port on the back
of your computer. With the thermometer turn o󰀨, connect
the interface cable to the data port located at the bottom of
the thermometer. Then “ PCL ” will appear in the display,
indicating that the thermometer is ready to transmit data.
Step 3 Transmit Data
Follow the instructions provided in the software to
transmit data. Results transmitted will include date
and time. Remove the cable and the thermometer will
automatically turn o󰀨.
Transmitting data via Bluetooth
Adapter (FORA IR21b / IR20b)
Step 1
Install Health Care System Software on your computer
by following the instructions provided on ForaCare’s
website.
Step 2
Install Bluetooth Adapter Software.
Step 3
Reset FORA IR21b / IR20b thermometer.
Step 4

EN-12
Pair FORA IR21b / IR20b thermometer with your
computer. Select FORA IR21b / IR20b thermometer
device code: “FORA-Device” and key in the Bluetooth
passkey (PIN): 111111 for pairing.
Step 5
Connect Bluetooth Serial Port Service:
Right click on icon “FORA-Device” and select “connect”
and “Bluetooth Serial Port Service” for connection.
The results will be transmitted automatically to your
computer once you nish taking the temperature. In
the meanwhile, the communication symbol on the
thermometer will ash.
If you are using the Bluetooth Adapter provided by
ForaCare Suisse AG, please follow the installation guide
“Bluetooth Easy Card” within the package.
Bluetooth Indicator Description
Flash fast The meter is searching
the device of Bluetooth
signal.
Flash slowly The meter is pairing with
the device of Bluetooth.
Lit solid The meter is
transmitting the data
now the connection is
completed.
Bluetooth
Indicator
NOTE
While the thermometer is connected to the PC or the server, it
is unable to perform a test.
We recommend that you use bluetooth adaptor provided by
ForaCare Suisse AG.
Care & Cleaning
Keep the probe clean, as earwax
and grease build up may a󰀨ect the
measurement.
The probe tip is the most delicate
part of the thermometer. It has to be
clean and intact to ensure accurate
readings. Very gently wipe the surface with a cotton
swab.
The body of the thermometer is not water-resistant.
Never put the thermometer under a running tap or
submerge it into water. Use a soft and dry cloth to
clean it. Do not use abrasive cleaners.
Store the thermometer in a cool and dry location. Free
from dust and away from direct sunlight.

EN-13
Fever Indicator
When the measurement is equal or over 38°C (100.4°F),
red backlight is shown together with the result. The red
backlight will last for 3 seconds and turn o󰀨.
Troubleshooting
The table below shows problems you may encounter.
All error messages below would be shown together with
orange backlight. Please follow “what to do” to resolve
problems. If the problem still exists, please call your
local dealer for help.
Message What it means What to do
Room temperature is
below 10°C.
Put the thermometer under
operating temperature range
of 10°C to 40°C (50°F to
104°F).
Room temperature is
above 40°C.
Put the thermometer under
operating temperature range
of 10°C to 40°C (50°F to
104°F).
You don’t use probe
cover while measuring
ear temperature.
Please place probe cover into
probe again.
Problem with the
thermometer.
Review the instructions and
re-start the measurement
procedure. If the above steps
do not work.
Please contact the dealer.
Battery is low and “ ”
appears on LCD.
Please replace batteries as
soon as possible.
Appears when the
batteries can’t provide
enough power for a test.
Please replace new batteries.
Temperature
measurement
falls outside the
displayed temperature
range: (ear temperature
range from 32°C to
43°C. skin/surface scan
temperature range from
22°C to 44°C.)
Please follow this manual to
take a reading again.

EN-14
Specications
The specications may be changed without prior notice.
This device has been tested to meet the electrical and safety
requirements of: ASTM E1965-98, EN 12470-5, EN 60601-1-
2:2007/AC:2010, EN 60601-1-4:1996, EN 60601-1-6:2010, EN
301 489-17, EN 300 328.
Dimensions
162.2mm (L) x 32.4mm (W) x
38.0mm (H) (FORA IR21)
160.5mm (L) x 32.5mm (W) x
45.9mm (H) (FORA IR20)
Weight
110.0g (include 2 x1.5V AAA
batteries) (FORA IR21)
105.5g (include 2 x1.5V AAA
batteries) (FORA IR20)
Battery 2 x 1.5V AAA alkaline batteries
External output RS-232 / USB / Bluetooth
Displayed
temperature range
32°C to 43°C (89.6°F to
109.4°F)
Display resolution 0.1°C / 0.1°F
Accuracy
Meet the accuracy requirement
specied in ASTM E1965-98
±0.2°C(±0.4°F) for the range
of 36.0°C to 39.0°C(96.8°F to
102.2°F)
±0.3°C(±0.5°F) from 34.0°C
to 35.9°C (93.2°F to 96.6°F) and
from 39.1°C to 42.2°C(102.4°F
to 108.0°F)
Temperature unit °C / °F
Operating temperature range 10°C to 40°C (50°F to 104°F)
Operating humidity 95% RH or less
Symbol Information
Symbol Referent
Consult instructions for use
Manufacturer
Serial number
Caution, consult accompanying documents
Type BF Equipment
CE Mark
Disposal of waste equipment
Storage temperature range -20°C to 60°C (-4°F to 140°F)
Storage humidity 95% RH or less
Memory capacity 10 measurements

EN-15
Meter Disposal
The used meter should be treated as contaminated and
may carry a risk of infection during measurement. The
batteries in this used meter should be removed and
the meter should be disposed in accordance with local
regulations.
The meter falls outside the scope of the European
Directive 2002/96/ EC-Directive on waste electrical and
electronic equipment (WEEE).
Storage/Transportation temperature limitation
Storage/ Transportation humidity limitation
Authorised representative in the European
Union
Medical Device
WARRANTY TERMS AND
CONDITIONS
With respect to disposable products, ForaCare Suisse
warrants to the original purchaser that, at time of delivery,
each standard product manufactured by ForaCare Suisse
shall be free of defects in material and workmanship and,
when used for the purposes and indications described on
the labeling, is t for the purposes and indications described
on the labeling. All warranties for a product shall expire as
of the product expiration date, or if none, after two (2) year
from the original date of purchase, as long as it has not been
modied, altered, or misused. ForaCare Suisse warranty
hereunder shall not apply if:
(i) a product is not used in accordance with its instructions
or if it is used for a purpose not indicated on the labeling; (ii)
any repairs, alterations or other work has been performed by
the buyer or others on such item, other than work performed
with ForaCare Suisse’s authorisation and according to its
approved procedures; or (iii) the alleged defect is a result
of abuse, misuse, improper maintenance, accident or the
negligence of any party other than ForaCare Suisse. The
warranty set forth herein is conditioned upon proper storage,
installation, use and maintenance in accordance with
applicable written recommendations of ForaCare Suisse.
The warranty furnished hereunder does not extend to
damage items purchased hereunder resulting in whole or
in part from the use of components, accessories, parts or
supplies not furnished by ForaCare Suisse.

EN-16
Warning: Medical electrical equipment needs special precautions regarding EMC and needs to be installed according
to the EMC information provided. Careful consideration of this information is essential when stacking or collocating
equipment and when routing cables and accessories.
Warning: RF mobile communications equipment can a󰀨ect medical electrical equipment.
Recommended separation distance between
portable and mobile RF communications equipment and FORA IR20/IR21
FORA IR20/IR21 is intended for use in an electromagnetic environment (for home healthcare and professional healthcare) in which radiated RF disturbances are
controlled. The customer or the user of FORA IR20/IR21 can help prevent electromagnetic interference by maintaining a minimum distance between the portable and
mobile RF communications equipment (transmitters) and FORA IR20/IR21 as recommended below, depending on the maximum output power of the communications
equipment.
Rated maximum output power of
transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
d =1,2√P
80 MHz to 800 MHz
d =1,2√P
800 MHz to 2,7 GHz
d =2,3√P
0,01 N/A 0,12 0,23
0,1 N/A 0,38 0,73
1 N/A 1,2 2,3
10 N/A 3,8 7,3
100 N/A 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation
applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W) depending on the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply to all situations. Electromagnetic propagation is a󰀨ected by absorption and reection from structures, objects and people.

EN-17
Manufacturer’s declaration-electromagnetic emissions
FORA IR20/IR21 is intended for use in the electromagnetic environment (for home healthcare and professional healthcare) specied below.
The customer or the user of FORA IR20/IR21 should assure that it is used in such an environment.
Emission test Compliance Electromagnetic environment-guidance
(for home healthcare and professional healthcare)
RF emissions CISPR 11 Group 1 FORA IR20/IR21 uses RF energy only for internal use. Therefore, its RF emissions are very
low and are not likely to cause any interference from nearby electronic equipment.
RF emissions CISPR 11 Class B FORA IR20/IR21 is suitable for use in all establishments, including domestic establishments
and those directly connected to the public low-voltage power supply network that supplies
buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Not applicable
Voltage uctuations/icker emissions
IEC 61000-3-3
Not applicable

EN-18
Manufacturer’s declaration-electromagnetic immunity
FORA IR20/IR21 is intended for use in the electromagnetic environment (for home healthcare and professional healthcare) specified below.
The customer or the user of FORA IR20/IR21 should assure that it is used in the environment specified below.
Immunity test IEC 60601
test level
Compliance level Electromagnetic environment-guidance
(for home healthcare and professional healthcare environment)
Electrostatic discharge (ESD)
IEC 61000-4-2
Contact: ±8 kV
Air ±2 kV, ±4 kV, ±8 kV, ±15 kV
Contact: ±8 kV
Air ±2 kV, ±4kV, ±8 kV, ±15 kV
Floors should be wood, concrete or ceramic tile. If floors are
covered with synthetic material, the relative humidity should be
at least 30 %.
Electrical fast transient/burst
IEC 61000-4-4
±2 kV for power supply lines
±1 kV for input/output lines
Not applicable
Not applicable
Mains power quality should be that of a typical home and
professional healthcare environment.
Surge IEC 61000-4-5 ±0.5 kV, ±1 kV line(s) to line(s)
±0.5 kV, ±1 kV, ±2 kV line(s) to earth
Not applicable
Not applicable
Mains power quality should be that of a typical home and
professional healthcare environment.
Voltage Dips, short
interruptions and voltage
variations on power supply
input lines
IEC 61000-4-11
Voltage dips:
0 % UT; 0,5 cycle
0 % UT; 1 cycle
70 % UT; 25/30 cycles
Voltage interruptions:
0 % UT; 250/300 cycle
Voltage dips:
Not applicable
Not applicable
Not applicable
Voltage interruptions:
Not applicable
Mains power quality should be that of a typical home healthcare
and professional healthcare environment. If the user of FORA
IR20/IR21 requires continued operation during power mains
interruptions, it is recommended that FORA IR20/IR21 be
powered from an uninterruptible power supply or a battery.
Power frequency (50, 60 Hz)
magnetic field
IEC 61000-4-8
30 A/m
50 Hz or 60 Hz
30 A/m
50 Hz and 60 Hz
FORA IR20/IR21 power frequency magnetic fields should be
at levels characteristic of a typical location in a typical home
healthcare and professional healthcare environment.
NOTE UTis the a.c. mains voltage prior to application of the test level.