Radiant Innovation TH60N(E) User manual

TH60N(E) Multi-function Infrared Ear Thermometer
Functions
Room Temperature
Suitable ambient temperature is important for the baby and p
atient, the thermometer always help you recognize the
room temperature.
 When in power off, room temperature will always be shown on the screen with icon.
 Please see the “Use of the thermometer” section to learn how to get the correct room temperature.
 How to turn off oom Temperature: When in power on, press and hold the “ON/MEM” button for 5 sec. until
“OFF” will be shown on the screen to release the button.
Ear Temperature
The thermometer has been designed for practical use. It’s 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.
 Please see the “Use of the thermometer” section to learn how to measure the body temperature.
Surface Mode
The Surface
mode shows the actual, unadjusted surface temperatures, which is different from the body temperature. It
can help you to monitor if the object temperature is suitable for the baby or patient, for example the baby’s milk.
 Please see the “Use of the thermometer” section to learn how to measure the object temperature.
Fe er Alarm If thermometer detects a body temperature
≧ 37.5°
C under ear mode, there will be a long beep sound followed by
three short beep sound to warn the user for potential fever.
Last Reading When you get a new temperature reading in ear mode, the last reading will be shown on the screen (at top right
corner)
with the icon.
Memory Locations There are total 25 sets memories for ear measurements.
 When in power on, Press the “ON/MEM” button to see the temperature stored with icon.
°C / °F Switch
 In “power off” mode (The LCD only shows the room temperature). Press and hold the “SCAN”
button, then
immediately press and release the “ON/MEM” button. After 3 seconds, icon “°C” will be switched to icon “°F”
. (You may
use the same way to switch back to “°C”)
Use of the thermometer
1. Always make sure the probe is clean, and without damage.
2. Power on: Press “ON/MEM” button.(see figure 1)
3. Mode selection:
3.1 Ear mode: Press the “ON/MEM” button, the default mode of thermometer is ear mode. The thermometer is ready
for use after you see the icon on the screen and hear two beep sounds (see figure 1). In
this mode, you can get the body temperature by ear measurement.
3.2 Surface Mode: After power on, press and hold the “ON/MEM” button, and press the “SCAN” button
one time for “Infrared thermometer” mode to see icon on your LCD display (see figure2).
In this mode, you can get the target surface temperature.
4. Temperature taking:
4.1 Ear temperature measuring, points for attention:
Remarks: a. It is recommended that you measure 3 times with the same ear. If the 3 measurements are different, select the highest temperature.
b. Before the measurement, please stay in a stable en ironment for 5mins and a oid the exercise, bath for 30mins
c. To a oid the risk of cross contamination, please clean the probe according to “ Care and cleaning ” section after each use.
d. The different temperature aries in healthy persons between different parts of the body can be between 0.2~1°C
e. Clinical repeatability: 0.23°C (<1 year old),0.22°C (1~5 years old),0.21°C (>5 years old)
** When you get a new temperature reading in ear mode, the last reading will be shown on the screen (at top right corner) with the icon.**
Specifications
Temperature measurement range:
Ear mode: 34~42.2°C (93.2~108°F), Surface mode: -22~80°C (-7.6~176°F)
Operating temperature range: 10~40°C (50~104°F)
Storage temperature range: It should be stored at room temperature between -20~+50°C,
H ≦ 85%
Transportation temperature shall be less than 70°C, H ≦ 95%
Comply 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:
For ear mode: +/-0.2°C (0.4°F) within 35.5~42°C (95.9~107.6°F),
+/-0.3°C (0.5°F) for other range.
For 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.
Fever alarm & Temperature records under “Ear mode”
°C / °F Switch mode
 Battery: one lithium cell battery (C 2032 *1pcs)
 This thermometer converts the ear temperature to display its “oral equivalent.”
E:LED Back Light (optional)
LED Back Light will automatically turned on after measurement, and automatically turned
off after 5 seconds.
There is no gender and age limitation for using infrared thermometer.
This is not an AP or APG product.
Figure 1 Figure2
4.1.1 Gently pull
the ear back to straighten the ear canal (Fig.4.1.1) and snugly position the probe into the ear canal, aiming towards the
membrane of the eardrum to obtain an accurate reading (Fig.4.1.2).
4.1.2 Press and hold the “SCAN” button until you hear a beep sound
. emove the probe from ear and read the temperature
measurement on the LCD.
( ear Cover)
Figure. 4.1.1
Figure 4.1.2

Ref No. ： 032012
Ref No. ： 082012
4.2 Measuring temperature under Surface mode:
4.2.1 When you press the “SCAN” button, you will get the real time temperature immediately. If you press and hold the “SCAN” button, the reading of measurement
will be continuous updated.
4.2.2 Applications include temperature measurements for Water, Milk, Cloth, Skin or other object.
* Note: This mode shows the actual, unadjusted surface temperatures, which is different from the body temperature.
4.3 Get the room temperature
4.3.1 For room temperature, the thermometer should be placed on the table and avoid the direct sunshine or air conditioner flow on.
4.3.2 When in power off, room temperature will always be shown on the screen with icon.
4.3.3 The room temperature can be reference after 15min later.
5. After Measurement:
5.1 Power off: Device will automatically shut off if left idle for more than 1 minute to extend battery life. The LCD will only show the room temperature.
5.2 Clean the probe after each use to ensure an accurate reading and avoid cross contamination. (See the section of Care and Cleaning for details.)
5.3 emember to put on the Probe Cap when not in use.
Important Notes
Care and cleaning
The probe is the most delicate part of the thermometer. Use with care when cleaning the lens to a oid damage.
a. After the measurement, please use the cotton swab with the 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.
c. Storage temperature range: It should be stored at room temperature between -20~+50°C , H ≦ 85%
d. Keep the unit dry and away from any liquids and direct sunlight.
e. The Probe should not be submerged into liquids.
* 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.
Battery replacement
○
1
Open the battery cover: Insert a pointed object, such as a pen, into battery cover pick hole.
At the same time, use thumb to push battery cover out.
○
2
Hold the device and flip the battery out with a small screwdriver
○
3
Insert 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
○
4
eplace the battery cover
Keep the battery away from children.(This device is supplied with one lithium cell
(C 2032x1).)
The positive (+) side up and the negative (-) side pointed down.
Trouble shooting:
Error Message
Problem Solution
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.
Measurement before device stabilization. Wait until all the icons stops flashing.
The device showing a rapid ambient temperature change.
The ambient temperature is not within the range between 10
o
C~40
o
C (50
o
F ~104
o
F).
Allow the thermometer to rest in a room for at least 30 minutes at room
temperature: 10
o
C and 40
o
C (50
o
F ~104
o
F).
(1) In Ear mode: Temperature taken is higher than +42.2
o
C (108°F)
(2) In Surface mode: Temperature taken is higher than +80
o
C (176°F)
(1) In Ear mode: Temperature taken is lower than +34
o
C (93.2°F)
(2) In Surface mode: Temperature taken is lower than –22
o
C (-7.6°F)
Please select the target within specifications. If a malfunction still exists,
please contact the nearest retailer.
Device cannot be powered on to the ready stage. Change with a new battery.
Warranty:
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:E912A000001, the first “E” is External, the second number “9” is the manufacture year 2009, 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 at any time you question the accuracy of temperature measurements, please contact the
dealers or nearest ser ice address.
Please read the instructions for use BF type applied part
adiant Innovation Inc. Http
://www.radiantek.com.tw
Add: 1F, No.3, Industrial East 9
th
oad, Science-Based Industrial Park,
HsinChu, Taiwan 300.
Medical Technology Promedt Consulting GmbH
Add: Altenhofstrasse 80, D-66386 St. Ingbert, Germany

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.
To protect the environment, dispose of
useless device at appropriate collection sites
according to national or local regulations.
Authorized
representative in the
European community
Caution
Please read the instructions for use Manufacturer
BF type applied part
Battery Recycling Paper Recycling
Guidance and manufacturer’s declaration – electromagnetic emissions
The TH6xyz series is intended for use in the electromagnetic environment specified below. The customer or the user of the TH6xyz series
should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions
CISPR 11 Group 1
The TH6xyz 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 TH6xyz 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 TH6xyz series is intended for use in the electromagnetic environment specified below. The customer or the user of the TH6xyz 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 TH6xyz 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 = 2,3 800 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
TH6xyz series is used exceeds the applicable RF compliance level above, the TH6xyz series should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the TH6xyz 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 immunity
The TH6xyz series is intended for use in the electromagnetic environment specified below. The customer or the user of the TH6xyz 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 TH6xyz series
requires continued operation during power mains
interruptions, it is recommended that the TH6xyz 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 TH6xyz series is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the
user of the TH6xyz series can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the TH6xyz 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.