Radiant Innovation TH809 User manual

** Replace the probe cover after each use to ensure
an accurate reading and avoid cross contamination.
TH809 Ear-Type Thermometer
Intended use: The ear thermometer is electronic thermometer using
an infrared detector (thermopile detector) to detect body temperature
from ear canal in people of all ages.
Intended operator: Have eight years of education, no maximum.
Thank you for purchasing the thermometer. This thermometer is
designed with an advanced infrared and ambient temperature
compensation technology for instantaneous self-diagnosis and
accurate temperature measurements. 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:
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.
1. Gently squeeze the opposite ends of the thermometer to pull off the probe cap. Do not use force to remove the cap.
2. Always use a new and undamaged probe cover. Make sure the ear canal 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.
3. Install Probe Cover
1) Place a new probe cover on the connection ring. (See Figure 1)
NOTE：Make sure to place the “Adhesive Side” of probe cover “Upward.”
2) Align the probe with the center of probe cover. Insert the probe into the probe cover on the connection ring. (See Figure 2)
3) Push the connection ring until the “Click” sound. This means the probe cover has been installed successfully.
NOTE：If the probe cover did not install well, will flash on the LCD screen and can’t take the ear temperature (will hear
4 beep sounds without reading shown on the LCD when measuring). Please check the setting of the probe cover
again.
Proper installation of the probe cover and using the specific probe cover ensure accurate measurements.
4. Press “ON/MEM” button to power on. The thermometer is ready for use after the ear icon stop flashing and two short beep
sound.
5. Gently pull the ear back to straighten the ear canal and snugly position the probe into the ear
canal, aiming towards the membrane of the eardrum to obtain an accurate reading. (Fig.4-1)
6. Measuring the ear temperature：Use the index finger to trigger. Press the “Scan” button until
you hear a long beep. (Fig.4-2). After each ear measurement, wait icon stop flashing to be ready for next measurement.
7. Power off：This device will automatically shut down after 1 minute pending to extend battery life.
NOTE：
a. Before the measurement, the subject should stay in a stable environment for 5mins and avoid the exercise, bath for
30mins.
b. It is recommended that you measure 3 times with the same ear. If the 3 measurements are different, select the
highest temperature.
c. To avoid the risk of cross contamination, please clean the probe according to “Cleaning and Storage” section after
each use.
d. The "Clinical Bias” is -0.2 ~ -0.4°C.
e. The "Limits ofAgreement” is 0.58.
f. The "Repeatability” is 0.17°C.
Fever Indication:
If the thermometer detects a body temperature ≥37.5°C (or 99.5°F), three short beep sound will follow one long beep sound to warn
the user for potential fever.
Switching between Fahrenheit(°F) and Celsius (°C):
In “Power Off” mode, press and hold the “SCAN” 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.
Memory Function:
When in power on, press the “ON/MEM” button to see the temperature stored. The thermometer provides 9 sets memory for the
body temperature.
Cleaning and Storage:
The probe is the most delicate part of the thermometer.
Use with care when cleaning the lens to avoid damage.
Storage temperature Range: It should be stored at room temperature between -20~+50°C, RH≤85%
Keep the unit dry and away from any liquids and direct sunlight.
The Probe should not submerge into any liquids.
** If device is accidentally used without probe cover, clean the probe as follows:
a. Please use alcohol swabs or cotton swabs moistened with 70%~75% alcohol to clean the probe lens.
b. Allow the probe to fully dry for at least 1 minute.
NOTE：Please check the device if damaged once it falls. If you can’t make sure of it, please send the complete
device to the nearest retailer for recalibration.
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.
Changing the Battery:
This device is supplied with one lithium cell (CR2032 x 1).
○
1Open the battery cover: Insert a pointed object into the battery cover pick hole. At the same time, use thumb to remove battery
cover. (See Figure 1) ○
2Flip the battery out with a small screw driver (See Figure 2) ○ 3Insert the new battery under the metal
hook and press the other side of the battery down until you hear a “click”. (See Figure 3) ○
4Replace the battery cover.
The positive (+) side Up and the negative (-) side pointed Down.
Specifications:
Temperature measurement range: 34~42.2°C (93.2~108°F)
Operating temperature range: 10~40°C (50~104°F) , 15%~85% RH
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%
Atmospheric pressure: 800~1013 hPa
Comply with ASTM E1965-98, EN ISO 80601-2-56, IEC/EN60601-1-2(EMC), IEC/EN60601-1(Safety) standards, ISO10993,
RoHS.
Accuracy: ±0.2°C (0.4°F) within 35~42°C (95~107.6°F), ±0.3°C (0.5°F) for other range.
Figure 4-1 Figure 4-2
Figure 1 Figure 2
Figure 1 Figure 2 Figure 3

This thermometer is an adjusted mode thermometer that converts the ear temperature to display its “oral equivalent.”
(according to the result of the clinical evaluation to get the offset value)
Enclosure Rating: IP22
Dimensions: 141.4 x 40.4 x 43.5 mm
Weight: 67.3 grams including battery
Battery life: around 3,000 continuous readings.
Expected Service Life: 4 years
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.
Troubleshooting:
Error Message Problem Solution
Device stabilization is in process. Wait until stops flashing.
Battery is low and no more measurements are
possible. Replace the battery.
Measurement before device stabilization. Wait for “Er1” to disappear.
The ambient temperature is not within the normal
temperature range between 10 oC and 40 oC (50 oF
~104 oF).
Allow the thermometer to rest in a room at least 15
minutes at room temperature: 10 oC and 40 oC (50 oF
~104 oF).
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 oC (108.0 oF). Check the integrity of the probe cover and take a new
temperature measurement.
Temperature taken is lower than 34 oC (93.2 oF). Make sure the probe cover is clean and take a new
temperature measurement.
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 incidentthat 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?
Radiant Innovation Inc. Medical Technology Promedt Consulting Gmb
Tel: [phone] Fax: [phone] Add: Altenhofstrasse 80, D-66386 St. Ingbert, Germany
E-mail: [email protected] Http://www.radiantek.com.tw
Add: 1F, No.3, Industrial East 9th Road, Science-Based Industrial Park,
HsinChu
,
Taiwan 300.
Date of issue: 2020-06-15
Ref No.: 062020

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.
Do not reuse
Caution
Please read the instructions for
use
Paper
Recycling
Manufacturer
To protect the environment,
dispose of empty batteries at
your retail store or at
appropriate collection sites
according to national or local
regulations.
BF type
applied part
Authorized representative in
the European community IP22 Classification for water ingress and particulate matter.
Manufacturer’s declaration-electromagnetic emissions
The TH8xyz series is intended for use in the electromagnetic environment (for home healthcare) specified below.
The customer or the user of the TH8xyz series should assure that it is used in such an environment.
Emission test Compliance Electromagnetic environment-guidance
(for home healthcare environment)
RF emissions CISPR 11 Group 1 The TH8xyz 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 TH8xyz 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.
Manufacturer’s declaration-electromagnetic immunity
The TH8xyz series is intended for use in the electromagnetic environment (for home healthcare) specified below.
The customer or the user of the TH8xyz 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 TH8xyz 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 TH8xyz series is intended for use in the electromagnetic environment (for home healthcare) specified below.
The customer or the user of the TH8xyz series should assure that is used in such and environment.
Immunity test IEC 60601 test
level Compliance 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, ashould 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 TH8xyz series is used exceeds the applicable RF compliance level above,
the TH8xyz 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 TH8xyz series.
Recommended separation distance between
portable and mobile RF communications equipment and the TH8xyz series
The TH8xyz 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 TH8xyz series can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the
TH8xyz 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
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 din 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.
NOTE1 At 80 MHz and 800 MHz, the separation distance for 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.
Manufacturer’s declaration-electromagnetic immunity
Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment
The TH8xyz series is intended for use in the electromagnetic environment (for home healthcare) specified below.
The customer or the user of the TH8xyz 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
1 720
1 700 –
1 990
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25; UMTS
Pulse
modulation b)
217 Hz
2 0,3 28 28
1 845
1 970
2 450 2 400 –
2 570
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
Pulse
modulation b)
217 Hz
2 0,3 28 28
5 240
5 100 –
5 800
WLAN 802.11
a/n
Pulse
modulation b)
217 Hz
0,2 0,3 9 9
5 500
5 785
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.