Radiantek TH008A User manual

TH008A Multi-function Infrared Thermometer
Functions
Real Time Clock
The real time clock will be recorded with the memory function and help you to recognize each measurement
result. (It includes the 12/24 ormat_Hour_Minutes_Date.)


 Please see the “Real time clock setting section to learn how to setup the time in the first use.

Room Temperature
Suitable ambient temperature is important for the baby and patient, the thermometer always help you recognize
the room temperature.
 Setting “Real time clock” first to enable this function. After power off, room temperature will be shown
on the screen with icon.
 Please see the “Use of the thermometer” section to learn how to get the correct room temperature.
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 see the “Use of the thermometer” section to learn how to measure the body temperature.
Stopwatch
The thermometer built the stopwatch function to help you to monitor the heartbeat
since heartbeat is one of the
healthy indexes for people.
 Please see the “Use of the Stopwatch” section to learn how to measure the heartbeat result.
Fever 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.
Memory Locations
There are total 9 sets memories for body temperature measurements. Each memory also records the
measurement date/time/mode icon.
 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 date, time and 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 “° ”. (You may use the same way to switch back to “°C”)
Real time clock setting
1. Power on: Press the “ON/MEM” button. The thermometer is ready for use after hearing two beep sounds.
2. Press and hold the “ON/MEM” button for 5sec. When you see the Set icon starts flashing, it indicates that you are in the setting screen.(see the following figure.)
3. Press the “SCAN” button to make the “24” icon flash. This indicates that you are in the 12/24-hour setting screen. Press the “SCAN” button to set 12/24-hour ormat
from “24”(24-hour) to “12”(12-hour).
4. Press “ON/MEM” button to move the flashing in the sequence shown below to select our settings:
hourminutesyearmonthdayleave the setting screen.
5. While the hour, minutes, year, month, day setting is flashing, use “SCAN” button to change it.
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: The preset mode of thermometer.
 Press the “ON/MEM” button. Now the thermometer is ready for use after you see
the icon on the screen and hear two beep sounds. (see figure 1)
3.2 Stopwatch:  P ress and hold the “ON/MEM” button, and press the “SCAN” button one time for “stopwatch” mode. On your LCD display, icon will replace icon. In this mode,
you can count by 0.01sec to 3 minutes. (see figure 2)
4. Temperature taking:
4.1 Body Temperature: It is recommended that you measure 3 times with the same ear. If the 3 measurements are different, select the highest temperature.
4.1.1 Gently pull the ear back to straighten the ear canal ( ig.4.1.1) and snugly position the probe into the ear canal, aiming towards the
membrane of the eardrum to obtain an accurate reading ( ig.4.1.2).
4.1.2 Press and hold the “SCAN” bu
tton until you hear a beep sound. Remove the probe from ear and read the temperature
measurement on the LCD.
Remarks: a. To avoid the risk of cross contamination, please clean the probe according to “Care and cleaning section after each use.
b. Before the measurement, please stay in a stable environment for 5 mins and avoid exercise, bath for 30 mins.
c. The different temperature varies in healthy persons between different parts of the body can be between 0.2~1°C
d. Clinical repeatability: 0.23°C (<1 year old),0.22°C (1~5 years old),0.21°C (>5 years old)
Specifications Temperature measurement range: 34~42.2°C (93.2~108° )
Operating temperature range: 10~40°C (50~104° )
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%
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: +/-0.2°C (0.4° ) within 35.5~42°C (95.9~107.6° ), +/-0.3°C (0.5° ) for other range.
ever alarm & Memory locations under Ear mode (with each measurement date/time/mode icon)
Real time clock, °C / ° Switch mode
Battery: one lithium cell battery (CR2032 *1pcs)
This thermometer converts the ear temperature to display its “oral equivalent.”
There is no gender and age limitation for using infrared thermometer.
This is not an AP or APG product.
Do not use this device for Live & Dead decision or Safety related applications.
Please consult with doctor if you have health concerns.
igure 1 igure 2
igure 4.1.1
igure 4.1.2

4.2 Get the room temperature
4.2.1 Setting “Real time clock” first to enable this function. After power off, room temperature will be shown on the screen with icon.
4.2.2 or room temperature, the thermometer should be placed on the table and avoid the direct sunshine or air conditioner flow on.
4.2.3 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 date, time and 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 Remember to put on the Probe Cap when not in use.
Use of the Stopwatch
1. Press and hold the “ON/MEM” button, and press the “SCAN” button twice for “stopwatch” mode.
2. or start or stop counting, press the “SCAN” button; for reset counting, press the “ON/MEM” button.
3. Press and hold the “ON/MEM” button, and press the “SCAN” button to leave this mode.
4. How to measure the heartbeat? If you count out the number of beating is 18 in 15sec, then you can calculate the heartbeat of patient is 72 times in 1min.
Important Notes
Care and cleaning
The probe is the most delicate part of the thermometer. Use with care when cleaning the lens to avoid 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 , RH ≦ 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
Keep the battery away from children.
(This device is supplied with one lithium cell (CR2032x1).)
○
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
* The positive (+) side up and the negative (-) side pointed down.
○
4
Replace the battery cover
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 and 40
o
C (50
o
~104
o
).
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
~104
o
).
Temperature taken is higher than +42.2
o
C (108° )
Temperature taken is lower than +34
o
C (93.2° )
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: 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
Radiant Innovation Inc. Http://www.radiant
ek.com.tw
Add: 1 , No.3, Industrial East 9
th
Road, Science-Based Industrial Park,
HsinChu, Taiwan 300.
Medical Technology Promedt Consulting GmbH
Add: Altenhofstrasse 80, D-66386 St. Ingbert, Germany
Ref No. ： 052012

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 TH00xy series is intended for use in the electromagnetic environment specified below. The customer or the user of the TH00xy series
should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emissions
CISPR 11 Group 1
The TH00xy 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 TH00xy 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 TH00xy series is intended for use in the electromagnetic environment specified below. The customer or the user of the TH00xy 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 TH00xy 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
TH00xy series is used exceeds the applicable RF compliance level above, the TH00xy series should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the TH00xy 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 TH00xy series is intended for use in the electromagnetic environment specified below. The customer or the user of the TH00xy 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 TH00xy series
requires continued operation during power mains
interruptions, it is recommended that the TH00xy 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 TH00xy series is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the
user of the TH00xy series can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the TH00xy 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.