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
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.
Operating Instructions:
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.
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：The probe cover detector is optional. If the probe cover did not connect firmly, the “ ” icon
will flash on the LCD screen. Please check the setting of the probe cover again.
Proper installation of the probe cover ensures accurate measurements.
Warning：Keep the probe covers and connection ring away from children.
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 ).
7. Power off：This device will automatically shut down after 1 minute pending to extend battery life.
NOTE：
a. It is recommended that you measure 3 times with the same ear. If the 3 measurements are different, select the
highest temperature.
b. To avoid the risk of cross contamination, please clean the probe according to “Cleaning and Storage” section after
each use.
c. Clinical repeatability: 0.20°C (＜1 year old), 0.14°C (1~5 years old), 0.14°C (＞5 years old)
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:
If the reading of the thermometer is within normal temperature range between 34oC to 42.2 oC (93.2 oF to 108.0oF),
when the thermometer is off, the last measurement data is saved into memory. Press the “ON/MEM” button
again to see the temperature stored.
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 the cotton swab with Alcohol (70% concentration) to clean the lens( on the inside of the probe).
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
on the left side and press the right 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)
;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%
;Compliance with ASTM E1965-98, EN12470-5:2003 Clinical thermometers-Part 5:Performance of infra-red ear
thermometers(with maximum device),IEC/EN60601-1-2(EMC),IEC/EN60601-1(Safety) standards.
;Accuracy:+/-0.2 oC (0.4 oF) during 35.5~42°C (95.9~107.6°F), +/-0.3oC (0.5 oF) for other range.
;This mode converts the ear temperature to display its “oral equivalent.” (according to the result of the clinical evaluation)
Figure 4-1 Figure 4-2
Figure 1 Figure 2
Figure1 Figure2 Figure3

Ref No.：022010
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 until stops flashing.
The device shows a rapid ambient
temperature change.
Allow the thermometer to rest in a room for at
least 30 minutes at room temperature:
10 oC and 40 oC (50 oF ~104 oF).
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
30 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.
*Note: Suggest that the device is performed the re-test for accuracy after 3 years. Please send the complete
device to the dealers or nearest service address. However, if this device is used according to the
operation instruction, periodic re-calibration is not required.
Please read the instructions for use BF type applied part
Medical Technology Promedt Consulting GmbH
Add: Altenhofstrasse 80, D-66386 St. Ingbert, Germany
Radiant Innovation Inc.
Tel: [phone] Fax: [phone]
E-mail:servi[email protected].tw Http://www.radiantek.com.tw
Add: 1F, No.3, Industrial East 9th Road, Science-Based Industrial Park, HsinChu, Taiwan 300.

Symbol Descriptions
The CE mark and
Notified Body
Registration
Numbers, the
requirement of Annex
II from Medical
Device Directive
93/42/EEC are met.
Indicates this
device is subject to
the Waste
Electrical and
Electronic
Equipment
Directive in the
European Union.
Do not reuse
Please read the
instructions for use
Paper Recycling
Manufacturer
BF type applied part
Battery Recycling
Authorised
representative
in the
European
community
Guidance and manufacturer’s declaration – electromagnetic immunity
The TH8xyz series is intended for use in the electromagnetic environment 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
Conducted
RF
IEC
61000-4-6
Radiated RF
IEC
61000-4-3
3 Vrms
150 kHz to
80 MHz
3 V/m
80 MHz to
2,5 GHz
Not
applicable
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any part
of the TH8xyz series, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended separation distance
d = 1,2
d = 1,2 80 MHz to 800 MHz
d = 1,2 800 MHz to 2,5 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 meters (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:
NOTE 1 At 80 MHz and 800 MHz, 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.
a. 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 reorienting or relocating the TH8xyz series.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Guidance and manufacturer’s declaration – electromagnetic emissions
The TH8xyz series is intended for use in the electromagnetic environment specified below. The
customer or the user of the TH8xyz series should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
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
Harmonic
emissions
IEC 61000-3-2
Not applicable
Voltage
fluctuations/
flicker emissions
IEC 61000-3-3
Not applicable
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.

Guidance and manufacturer’s declaration – electromagnetic immunity
The TH8xyz series is intended for use in the electromagnetic environment 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
Electrostatic
discharge
(ESD)
IEC 61000-4-2
6 kV contact
8 kV air
6 kV
contact
8 kV air
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
Mains power quality should be that of
a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
1 kV line(s) to
line(s)
2 kV line(s) to earth
Not applicable
Mains power quality should be that of
a typical commercial or hospital
environment.
interruptions and
voltage
variations on
power supply
input lines
IEC 61000-4-11
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec
Not applicable
Mains power quality should be that of
a typical commercial or hospital
environment. If the user of the
TH8xyz series requires continued
operation during power mains
interruptions, it is recommended that
the TH8xyz series be powered from
an uninterruptible power supply or a
battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical
commercial or hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
Recommended separation distances between
portable and mobile RF communications equipment and the
ME EQUIPMENT or ME SYSTEM
The TH8xyz series is intended for use in an electromagnetic environment 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.
Separation distance according to frequency of transmitter
m
Rated maximum
output power of
transmitter
W 150 kHz to 80 MHz
d = 1,2
80 MHz to 800 MHz
d = 1,2
800 MHz to 2,5 GHz
d = 2,3
0,01 0,12 0,12 0,23
0,1 0,38 0,38 0,73
11,2 1,2 2,3
10 3,8 3,8 7,3
100 12 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.