Radiantek TH709L User manual

Operating Instructions
Specifications
Temperature taking
Place the
Probe Cover
1.
Place the probe cover on the probe cover fixer(inside of
the storage box). Make sure to place the “Adhesive Side”
of probe cover “Upward.”
Align the probe with the center of the probe cover.
2. Insert the probe into the probe cover fixer (in the storage
box) until you feel a “click”. That means the probe cover
has been connected firmly.
1. Proper installation of the probe cover and using the
specific probe cover ensure accurate measurements.
2.
Warning:Choking fromswallowing 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.
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.
Power On
① ②
① Press “ON/MEM” button (on the left side)
② See the icon on the LCD and hear two beep sounds
Taking Ear
Temperature
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.
<For children under 2 years old>
Pull the ear straight back.
<For children over 2 years old and adults>
Pull the ear straight up and back.
Measuring
Press “Scan” button
(on the right side)
Press the “Scan” button for 1 second until you hear a long
beep sound. The measurement is completed. You can read
the result from LCD. After two short beeps are heard, the
icon stops flashing to be ready for next measurement.
Fever Indication :
If the thermometer detects a body temperature
≥37.5°C (99.5°F), three short beep sound will follow one long
beep sound to warn the user for potential fever.
Power Off Automatically shut down after 1 minute pending to extend battery life.
Attentions
a. 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.
b.
Before the measurement, the subject should stay in a stable environment for 5mins and avoid the exercise, bath for
30mins.
c. It is recommended that you measure the same ear for 3 times. If the 3 measurements are different, select the highest temp..
d. The thermometer has been designed for home use. It’s not meant to replace a visit to the doctor. Please also remember to
compare the measurement result to your regular body temp..
Please consult with doctor if you have health concerns.
Other Functions
Last Reading
After getting a new body temperature, the last reading will be shown on the screen (at top right corner)
with the icon.
Memory
Locations
(25 sets)
When power on, press the “ON/MEM” button to see the temperature records with icon.
°C / °F Switch
To change the LCD from °C to °F :
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.
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, °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 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)
E:LED Backlight (optional), LED Backlight will be automatically turned on after measurement, and automatically turned off after 5 seconds.
Enclosure Rating: IP22
Dimensions: 120.4 x 37.8 x 40.3 mm
Weight: 57.7 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 infrared thermometer. This is not an AP or APG product.
TH709L(E) Infrared Ear Thermometer Operating Instructions
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.
＞2 years
0 – 2 years


Normal Body Temperature
Normal body temperature is a range that will fluctuate throughout the day. The normal range for adult body temperature is typically considered to
be 36.1 to 37.8° C (97 to 100°F). The body temperature varies by age, person, gender, time of day, position of body, and is usually highest in the
evening. It can be affected by activity, emotion, clothing, medications, ambient conditions, hormones and other factors. Normal temperature will
also be different depending on the place on the body at which the temperature is taken, with rectal or ear temperature readings generally being
higher than oral temperature readings, and armpit temperature readings generally lower than oral readings.
Temperature variations affected by age:
The "Clinical Bias” is -0.2 ~ -0.4°C.
The "Limits of Agreement” is 0.58.
The "Repeatability” is 0.17°C.
Important Notes
Trouble shooting
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 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 incident that 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
Portable and mobile RF communication equipment can affect medical electrical equipment such as this product.
This device complies with CISPR 11 group 1, Class B. During measurement it is recommended to keep at least 1.5 meter separation between this
device and the surrounding electrical devices. If interference occurs, please increase the separation further or turn off the electrical equipment in
the vicinity. For detailed description regarding the EMC precautions you need to take, please contact our authorized representative or us on
address as given below.
Cleaning
And Storage
The probe is the most delicate part of the thermometer. Use with care when cleaning the lens to
avoid damage.
** Replace the probe cover after each use to ensure an accurate reading and
avoid cross contamination
.
a. Storage temperature range: It should be stored at room temperature between -20~+50°C , RH≤85%
b.
Transportation temperature shall be less than 70°C, RH ≤ 95%
c. Keep the unit dry and away from any liquids and direct sunlight.
d. The Probe should not be submerged into 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 if the device is damaged once it drops. If you can’t make sure of it, please send
the complete device to your local dealer 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
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.
2. Hold the device and flip the battery out with a small screwdriver.
3. Insert the new battery under the metal hook○
1
and press the other side○
2
of the battery down
until you hear a “Click”.
4. Replace the battery cover
The positive (+) side up and the negative (-) side pointed down.
Error Message Problem Solution
The probe cover has not been installed well Please check the setting of the probe cover again.
(Refer to the section of “Place the Probe Cover” )
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 for “Er1” to disappear.
The ambient temperature is not within the range between
10
o
C and 40
o
C (50
o
F ~104
o
F).
Allow the thermometer to rest in a room for at least 15
minutes at room temperature: 10
o
C and 40
o
C (50
o
F ~104
o
F).
Temperature taken is higher than +42.2
o
C (108°F)
Check the integrity of the probe cover and take a new
temperature measurement.
Temperature taken is lower than +34
o
C (93.2°F)
Make sure the probe cover is clean and take a new
temperature measurement.
Device cannot be powered on to the ready stage. Change with a new battery.
IMPORTER
Company Name?
Company Name?
General Information: Address? Website?
AGE
Temp.
Young
Old
High
Low
0 ~ 2 years: 36.4°C (97.5°F) ~ 38.0°C (100.4°F)
3 ~ 10 years: 36.1°C (97.0°F) ~ 37.8°C (100.0°F)
11 ~ 65 years: 35.9°C (96.6°F) ~ 37.6°C (99.7°F)
> 65 years: 35.8°C (96.4°F) ~ 37.5°C (99.5°F)

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-electroma
g
netic emissions
The TH7xy series is intended for use in the electromagnetic environment (for home healthcare) specified below.
The customer or the user of the TH7x
y
series should assure that it is used in such an environment.
Emission test Com
p
liance Electroma
g
netic environment-
g
uidance
(
for home healthcare environment
)
RF emissions CISPR 11 Group 1 The TH7xy series uses RF energy only for its internal function. Therefore, its RF emissions
are ver
y
low and are not likel
y
to cause an
y
interference in nearb
y
electronic e
q
ui
p
ment.
RF emissions CISPR 11 Class B The TH7xy 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
buildin
g
s used for domestic purposes.
Manufacturer’s declaration-electromagnetic immunity
The TH7xy series is intended for use in the electromagnetic environment (for home healthcare) specified below.
The customer or the user of the TH7x
y
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, 60Hz)
magnetic field IEC
61000-4-8
30 A/m
50 Hz or 60 Hz
30 A/m
50 Hz and 60 Hz The TH7xy series
power frequency magnetic
fields should be at levels characteristic of a
typical location in a typical home healthcare
environment.
Manufacturer’s declaration-electroma
g
netic immunit
y
The TH7xy series is intended for use in the electromagnetic environment (for home healthcare) specified below.
The customer or the user of the TH7x
y
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
√
P
d = 1,2
√P
80MHz to 800 MHz
d = 2,3
√P
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,
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:
NOTE1
A
t 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
TH7xy series is used exceeds the applicable RF compliance level above, the TH7xy 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 TH7xy series.
R
ecommen
d
e
d
separat
i
on
di
stance
b
etween
p
ortable and mobile RF communications e
q
ui
p
ment and the TH7x
y
series
The TH7x
y
series is intended for use in an electroma
g
netic environment
(
for home healthcare
)
in which radiated RF disturbances are
controlled. The customer or the user of the TH7xy series can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the TH7xy 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
√
P
80 MHz to 800 MHz
d =1,2
√
P
800 MHz to 2,7 GHz
d =2,3
√
P
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.
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 TH7xy series is intended for use in the electromagnetic environment (for home healthcare) specified below.
The customer or the user of the TH7x
y
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.