Radiant Innovation THP0FU User manual

THP0FU Non-contact Forehead Thermometer
Intended use: The infrared forehead thermometer can measure the infrared heat generated by central
forehead and surrounding tissues, to reflect patient’s body temperature accurately.
Functions
Forehead 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.
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.
Memory locations
There are total 25 sets of measurement condition for body temperature.
When power on, press the ON/MEM button to see the temperature records with icon.
°C / °F switch
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.

Use of the thermometer
Note: The device must stay in stable ambient (room) temperature for 15 minutes before operating.
1. Always 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.
2. Power on:
Press the ON/MEM button (see figure 1).
Figure 1
3. Measuring body temperature on the forehead:
Press the ON/MEM button to power on the device. Forehead mode is the default mode. You can see the icon on the screen
and hear two beep sounds (see figure 1). In this mode, you can hold the thermometer within 1 cm from the central forehead (Fig. 2) and press
the "Scan" button to get the forehead measurement. The time consuming for measurement might be 1 second. After each forehead
measurement, wait icon stop flashing to be ready for next measurement.
Figure 2
Points for attention:
a. Forehead temperature is displayed in oral mode. This mode converts the forehead temperature to display its “oral-equivalent”value.
b. Before the measurement, please stay in a stable environment for 5 minutes and avoid exercise, bath for 30mins.
c. Remember to keep the forehead area clean and away from sweat, cosmetics and scar while taking temperature.
d. The “Clinical Bias” is -1.4 ~ -1.7°C.
e. The “Limits of Agreement” is 0.98.
f. The "Repeatability" is 0.20°C.
4. Power off:
4.1 Device will automatically shut off if left idle for more than 1 minute to extend battery life.
4.2 Manually power off the device by pressing the ON/MEM button.
5.Communication Interface: 3-stage phone jack, the temperature reading will be outputted with “standard UART communication format” after finishing measurement.
Intended operator:
At least 11 years old (5 years intensive reading experience), no maximum.
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.
Fever indication, memory and °C/°F switch function
Battery: one lithium cell battery (CR2032 *1pcs).
Battery life: around 3,000 continuous readings.
Expected Service Life: 4 years
This thermometer converts the forehead temperature to display its “oral equivalent.”
(according to the result of the clinical evaluation to get the offset value)
Enclosure Rating: IP22
Dimensions: 136.3 x 48.7 x 40.4 mm
Weight: 65.3 grams including battery
The device should not submerge into any liquids and expose it to direct moisture.
There is no gender and age limitation for using the infrared thermometer.
This is not an AP or APG product.

Ref No.：052017
Important Notes
Cleaning
And Storage
Please make sure the probe is clean to ensure an accurate reading.
The probe lens is the most delicate part of the thermometer. Use with care when cleaning the probe lens to avoid damage.
a. Use the 70% alcohol swab or the soft cotton moistened with the 70% alcohol to clean the probe lens.
b. Allow the probe to fully dry for at least 1 minute.
c. Keep the unit dry and away from any liquids and direct sunlight.
d. Storage temperature range: It should be stored at room temperature between -20~+50°C, RH≦85%
e. The Probe should not be submerged into liquids.
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
This device is supplied with one lithium cell CR2032x1.
1. Open the battery cover: Insert a pointed object into battery cover pick hole. At the same time, use thumb to push battery cover out.
(See Figure 1)
2. Hold the device and flip the battery out with a small screwdriver. (See Figure 2)
3. Insert a new battery under the metal hook and press down until you hear a “click” sound. (See Figure 3)
4. Replace the battery cover
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 stop flashing.
The ambient temperature is not within the range between 10oC and 40oC (50oF ~104oF).
Allow the thermometer to rest in a room for at least 15 minutes at room
temperature: 10oC and 40oC (50oF ~104oF).
Temperature taken is higher than +42.2oC (108°F)
Please select the target within specifications. If a malfunction still exists,
please contact the nearest retailer.
Temperature taken is lower than +34oC (93.2°F)
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: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 at any time you question the accuracy of temperature measurements, please contact the
dealers or nearest service address.
Warning: No modification of this equipment is allowed.
Please read the instructions for use BF type applied part
Radiant Innovation Inc.
Http://www.radiantek.com.tw
Add: 1F, No.3, Industrial East 9th Road,
Science-Based Industrial Park, HsinChu, Taiwan 300.
Medical Technology Promedt Consulting GmbH
Add: Altenhofstrasse 80, D-66386 St. Ingbert,
Germany
Figure 1 Figure 2 Figure 3

Symbol Descriptions
The CE mark and Notified Body
Registration Numbers, the
requirement ofAnnex 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
IP22
Classification for water ingress and
particulate matter.
Guidance and manufacturer’s declaration – electromagnetic emissions
The THP0FU is intended for use in the electromagnetic environment specified below. The customer or the user of the THP0FU should assure that it is
used in such an environment.
Emissions test
Compliance
Electromagnetic environment –guidance
RF emissions
CISPR 11
Group 1
The THP0FU 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 THP0FU 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 fluctuations/
flicker emissions
IEC 61000-3-3
Not applicable
Guidance and manufacturer’s declaration – electromagnetic immunity
The THP0FU is intended for use in the electromagnetic environment specified below. The customer or the user of the THP0FU 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 THP0FU, 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 1At 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 THP0FU is used exceeds
the applicable RF compliance level above, the THP0FU should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the THP0FU.
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 THP0FU is intended for use in the electromagnetic environment specified below. The customer or the user of the THP0FU 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 THP0FU requires
continued operation during power mains interruptions, it is
recommended that the THP0FU 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 THP0FU is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the
THP0FU can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the THP0FU 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 2,5 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 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 1At 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.