Radiant Innovation TH20F User manual

Cleaning and Storage:
The Probe is the most delicate part of the thermometer.
Use with care when cleaning the probe to avoid damage.
a. Please use alcohol swabs or cotton swabs moistened with 70%~75% alcohol to clean the probe lens.
b. Allow the lens to fully dry for at least 1minute.
c. Keep the unit dry and away from any liquids and direct sunlight.
d. Clean the probe and probe lens after each use to ensure an accurate reading and avoid cross contamination.
Important Notes:
1. Before the measurement, the subject should stay in a stable environment for 5mins and avoid the exercise, bath for 30 mins..
2. Remember to keep the forehead area clean and away from sweat, cosmetics and scar while taking temperature.
3. During the measurement, please away from the direct sunshine and wind.
4. The "Clinical Bias” is -1.4 ~ -1.7°C.
5. The "Limits of Agreement” is 0.98.
6. The "Re
p
eatabilit
y
” is 0.20°C.
Date of issue: 2020-06-08
Ref No.: 062020
TH20F Non-contact Forehead Thermometer
Intended use: The non-contact forehead thermometer is electronic thermometer using an infrared
detector (thermopile detector) to detect body temperature from forehead center in people of all
ages.
Intended operator: Have eight years of education, no maximum.
Thank you for purchasing this Forehead thermometer. This thermometer is designed with
advance infrared and ambient temperature compensation technology for accurate and fast
temperature measurements. It also has a wide range mode to scan real time temperature.
It is for home use, not meant to replace a visit to the doctor. Please also remember to
compare the measurement result to your regular body temperature. Please consult with
doctor if you have health concerns.
Operating Instructions:
1Always make sure the probe lens is clean without any damage, and the forehead is clean.
Warning: Choking from swallowing small parts and batteries by children or pets is possible,
please keep small parts and batteries at places where children and pets can’t reach.
2Power on: Press the “ON/MEM” button.
3Mode selection:
3.1 FOREHEAD Mode: The preset mode of thermometer is forehead. The thermometer is ready for use after the “HEAD” icon stops flashing
and two beep sound.
3.2 SURFACE Mode: In “Power On” mode, press and hold the “ON/MEM” button, then press the “Meas.” button,the ‘ ’ icon will replace
“HEAD” icon in the LCD display.
4Temperature taking:
Note: If there is any temperature difference between the places where the device is stored and where you are going to measure,
subject and the device should stay in the same room for at least 15 minutes before measurement.
Figure 1
4.1 Measuring the FOREHEAD temperature: You can hold the thermometer within 1 cm from the central forehead (See
Figure 1) and press the “Meas.” button to get the forehead measurement. The time consuming for measurement might be
1 second.
Note: Forehead temperature is displayed in Oral Mode. This mode is an adjusted mode thermometer that converts the
forehead temperature to display its "Oral equivalent". (according to the result of the clinical evaluation to get the offset
value)
4.2 Measuring temperature under SURFACE mode: When you press the “Meas.” button, you will get the temperature immediately about 0.6 sec.
If you keep pressing the “Meas.” button, the reading of measurement will update continuously.
Note: Surface mode shows the actual, unadjusted temperatures, which is different from the forehead mode.
5. Switching between Celsius(°C) and Fahrenheit(°F):
To change the LCD from °C to °F: In “Power Off” mode, press and hold the “Meas.” button, then press the “ON/MEM” button for 3 seconds, icon
“°C” will be switched to icon “°F”. You can also use the same process to change the LCD display from °F to °C.
6. Memory Function: Press the “ON/MEM” button to see the temperature stored. This thermometer provides 25 sets memory for the body
temperature. ** Please notice that only the “HEAD” function’s reading will be recorded.
7. Power off: Device will automatically shut down after 1 minute pending to extend battery life. At next power on, it will go back to the default setting
of “HEAD” temperature function
Holding the thermometer too long may cause a higher ambient temperature reading of the probe.
This could make the body temperature measurement lower than usual.
Fever Indication:
If the thermometer detects a temperature ≥37.5°C (or 99.5°F) under forehead mode, three short beep sound will follow one long beep sound to
warn the user for potential fever.
Specifications:
The device should not submerge into any liquids and expose it to direct moisture.
There is no gender and age limitation for using infrared thermometer. This is not an AP or APG product.
Changing the Battery:
It is supplied with one lithium cell (CR2032x1pcs)
○
1Open the battery compartment by turning the cover 45° clockwise with a coin. ○ 2Remove the battery safety strip with a sharp-pointed object. ○ 3
Insert a new battery under the metal hook and press down until you hear a “click” sound ○
4Close the battery cover.
Disposal of the used batteries：Please comply with the local regulation.
Troubleshooting:
Error Message Problem Solution
Device stabilization in process. Wait until stops flashing.
Battery is low and no more measurements are possible.
Replace the battery.
The ambient temperature is not within the range between
10°C and 40°C (50°F~104°F).
Allow the thermometer to rest in a room at least 15 minutes at room
temperature: 10°C~40°C(50°F~104°F).
Error 5~9, the system is not functioning properly. Unload the battery, wait for 1 minute and repower it. If the message
reappears, contact the retailer for service.
Temperature taken is higher than 42.2°C (108.0°F) for
forehead mode or 80°C (176°F) for surface mode.
1) For forehead mode, please stay in a stable environment for 5mins
and avoid the exercise and bath for 30min, then make sure the probe
lens is clean before take a new temperature measurement.
2) For surface mode, please select target within specifications.
If a mal-function still exists, please contact the nearest retailer.
Temperature taken is lower than 34°C (93.2°F) for
forehead mode or –22°C (-7.6°F) for surface mode.
Device can not be powered on to the ready stage. Change with a new battery.
Warranty: 12 months
Manufacture Date: as the serial number (please open the battery cover, it is shown on the inside of the device.)
Ex.SN:E512A000001, the first “E” is External, the second number ”5” is the last number of manufacture year, the third and the fourth number “12” is
the manufacture month, the others is the serial number.
Note: The thermometer is calibrated at the time of manufacture. If you question calibration mode, the accuracy of temperature
measurements or unexpected events at any time, please contact the dealers or nearest service address.
Please report to the manufacturer and the competent authority of the Member State in which you are established about any serious
Incident that has occurred in relation to this device.
Warning: No modification of this equipment is allowed.
Please read the instructions for use BF type applied part
IMPORTER
Company Name?
Company Name?
General Information: Address? Website?
** The thermometer is NOT water-proof. Please
kee
p
the unit dr
y
and awa
y
from an
y
li
q
uids.
1. Comply with ASTM E1965-98, EN ISO 80601-2-56, IEC/EN60601-1-2(EMC), IEC/EN60601-1(Safety) standards, ISO10993, RoHS.
2. Temperature measurement range: Forehead mode 34~42.2°C (93.2~108°F), Surface mode: -22~80°C (-7.6~176°F)
3. Accuracy: Forehead mode: ±0.2°C (0.4°F) within 35~42°C (95~107.6°F), ±0.3°C (0.5°F) for other range.
Surface mode: ±0.3°C(0.5°F) within 22~42.2°C (71.6~108°F), others ±4% or ±2°C(4°F) whichever is greater.
4.Operating Range: 10~40°C (50 oF ~104 oF), 15%~85% RH
5. ** Storage temperature range: It should be stored at room temperature between -20~+50°C, RH≤85%
Transportation temperature shall be less than 70°C, RH≤95%
6. Atmospheric pressure: 800~1013 hPa
7. Enclosure Rating: IP22
8. Dimensions: 84.5 x 60.0 x 22.0 mm
9. Weight: 61.5 grams including battery
10. Battery life: around 3,000 continuous readings.
11. Expected Service Life: 4 years
Medical Technology Promedt Consulting GmbH
Add: Altenhofstrasse 80, D-66386 St. Ingbert, Germany
Radiant Innovation Inc.
Tel: [phone], Fax: [phone], E-mail:[email protected]
Add: 1F, No.3, Industrial East 9th Rd., Science-Based Industrial Park, HsinChu, Taiwan
Http://www.radiantek.com.tw

Symbol Descriptions
The CE mark and
Notified Body
Registration Numbers,
the requirement of
Annex II from Medical
Device Directive
93/42/EEC are met.
Please do not dispose of
the product in the
household waste at the
end of its useful life.
Disposal can take place at
appropriate collection
points provided in your
country.
Authorized
representative in
the European
community
Caution Please read the
instructions for use Paper Recycling
Manufacturer BF type applied part IP22 Classification for
water ingress and
particulate matter.
To protect the environment, dispose of empty batteries at your retail store or at appropriate collection sites
according to national or local regulations.
Manufacturer’s declaration – electromagnetic immunity
The TH2xyz series is intended for use in the electromagnetic environment (for home healthcare)
specified below. The customer or the user of the TH2xyz series should assure that it is used in such an
environment.
Immunity test IEC 60601 test
level Compliance
level
Electromagnetic environment –
guidance
(for home 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,±4
kV,±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%
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
The TH2xyz series power frequency
magnetic fields should be at levels
characteristic of a typical location in a
typical home healthcare environment.
Manufacturer’s declaration – electromagnetic immunity
The TH2xyz series is intended for use in the electromagnetic environment (for home healthcare)
specified below. The customer or the user of the TH2xyz series should assure that it is used in such an
environment.
Immunity test IEC 60601 test
level Complianc e level Electromagnetic environment – guidance (for home healthcare environment)
Radiated RF
IEC 61000-4-3 10 V/m
80 MHz – 2,7
GHz
80 % AM at 1
kHz
10 V/m
80 MHz –
2,7 GHz
80 % AM at
1 kHz
Recommended separation distance:
d = 1,2
d = 1,2 80MHz to 800 MHz
d = 2,3 800MHz to 2,7 GHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey, a
should be less than the compliance level in each
frequency range.b
Interference may occur in the vicinity
of equipment marked with the
following symbol:
NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
the TH2xyz series is used exceeds the applicable RF compliance level above, the TH2xyz series
should be observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as re-orienting or relocating the TH2xyz series.
Manufacturer’s declaration-electromagnetic emissions
The TH2xyz series is intended for use in the electromagnetic environment (for home healthcare)
specified below.The customer or the user of the TH2xyz series should assure that it is used in such an
environment.
Emissions test Compliance Electromagnetic environment – guidance
(for home healthcare environment)
RF emissions
CISPR 11 Group 1
The TH2xyz series uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby electronic
equipment.
RF emissions
CISPR 11 Class B
The TH2xyz series 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.

Recommended separation distances between
portable and mobile RF communications equipment and the TH2xyz series
The TH2xyz series is intended for use in an electromagnetic environment (for home healthcare) in which
radiated RF disturbances are controlled. The customer or the user of the TH2xyz series can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the TH2xyz series as recommended below, according to
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 80 MHz to 800 MHz
d = 1,2 800 MHz to 2,7 GHz d = 2,3
0,01 N/A 0,12 0,23
0,1 N/A 0,38 0,73
1N/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) according to 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 in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
Manufacturer’s declaration-electromagnetic immunity
Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment
The TH2xyz series is intended for use in the electromagnetic environment (for home healthcare) specified
below.The customer or the user of the TH2xyz series should assure that it is used in such an environment.
Test
frequency
(MHz)
Band a)
(MHz) Service a) Modulation b) Maximum
power
(W)
Distance
(m)
IMMUNITY
TEST LEVEL
(V/m)
Compliance
LEVEL
(V/m)
(for home
healthcare)
385 380–390 TETRA 400 Pulse modulation b)
18 Hz 1,8 0,3 27 27
450 430–470 GMRS 460,
FRS 460
FM c)
±5 kHz
deviation
1 kHz sine
2 0,3 28 28
710
704–787 LTE Band
13,17
Pulse
modulation b)
217 Hz 0,2 0,3 9 9
745
780
810
800–960
GSM
800/900,
TETRA
800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulation b)
18 Hz 2 0,3 28 28
870
930
1720
1700–
1990
GSM 1800;
CDMA
1900;
GSM
1900;
DECT;
LTE Band
1, 3,
4, 25;
UMTS
Pulse
modulation b)
217 Hz 2 0,3 28 28
1845
1970
2450 2400–
2570
Bluetooth,
WLAN,
802.11
b/g/n,
RFID 2450,
LTE Band 7
Pulse
modulation b)
217 Hz 2 0,3 28 28
5240 5100–
5800
WLAN
802.11
a/n
Pulse
modulation b)
217 Hz 0,2 0,3 9 9
5500
5785
NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the
transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m.
The 1 m test distance is permitted by IEC 61000-4-3.
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50 % duty cycle square wave signal.
c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used
because while it does not represent actual modulation, it would be worst case.