HoMedics HTD8816C User manual

HTD8816C
TE-350-EU
2 YEAR GUARANTEE

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FOREWORD
The Non-Contact Infrared Body Thermometer operating Instructions intend to provide
the necessary information for proper operation of the thermometer model.
Only body mode was reviewed and certified by notified body. General knowledge
of Infrared thermometer and an understanding of the features and functions of the
thermometer model are prerequisites for proper use. The Non-Contact Infrared Body
Thermometer is a medical device, and can be used repeatedly for the product’s
recommended lifetime of 5 years.
Please read the manual first before using it, if not fully understand the usages, please
stop using the thermometer.
Do not operate the thermometer without completely reading and
understanding these instructions.
Notice
Purchase or possession of this device does not carry any express or implied license to
use with replacement parts which would, alone or in combination with this device, fall
within the scope of one of the relating patents.
For further information contact:
HoMedics Group Ltd, Somerhill Business Park, Five Oak Green Road,
Tonbridge, Kent TN11 0GP.
Customer Service: [email protected]
Company Name: Wellkang Ltd
Company Address: 16 Castle St, Dover, CT16 1PW, UK
Tel: [phone]
Fax: [phone]
Web: www.CEmark.com, www.CE-marking.com, www.CE-marking.eu,
Email: [email protected]

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SAFETY INFORMATION
This device may only be used for the purposes described in these instructions.The
manufacturer cannot be held liable for damage caused by incorrect application.
The Non-Contact Infrared Body Thermometer is designed to minimize the possibility of
hazards from errors in the software program by following sound and light engineering
design processes, Risk Analysis and SoftwareValidation.
WARNING
Warnings are identified by the WARNING symbol shown above.
• The Non-Contact Infrared Body Thermometer is to be operated by consumers in the
home setting and primary care setting as screening tool. This manual, accessories,
Directions for Use, all precautionary information,and specifications should be read
before use.
• This product is designed to measure human body temperature on the forehead. Do not
use it for any other purpose.
• This product is intended for use in the home setting and primary care setting as
screening tool.
• Do not use the thermometer if it malfunctions or has been damaged in any matter.
• When the ambient temperature of the thermometer changes too much, such as
moving the Thermometer from one place of lower temperature to another place of
higher temperature,allow the thermometer to remain in a room for 30 minutes where
the temperature is between 15°C to 40°C (59°F- 104°F).
• Remove primary batteries if equipment is not likely to be used for long time.
• This product is not waterproof, do not immerse in water or other liquid; If cleaning
and disinfecting, please follow the “Care and Storage” section requirements.
• Do not touch the sensor of infrared detection with your fingers.
• Avoid using the thermometer to take a body temperature reading while using a cold
compress or other measure to reduce fever.
• If measuring human forehead temperature, please select “body” mode; for measuring
other objects, liquids, food and other temperature please select “surface” mode.
• This product must be operated in a stable environment. If the ambient environment
is unstable, please check whether there is fog on the sensor and remove this before
using in accordance with the “Care and Storage” section.

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• Do not near strong electrostatic field or strong magnetic fields, thus avoiding the
impact on the accuracy of the measurement data.
• Do not mix the old and new batteries to avoid damage to the product.
• It may aect the accuracy of measurements when the forehead is covered by hair,
perspiration, cap or scarf.
• The measuring result of this product is only for your reference. If you have any doubt,
please measure the temperature in other methods.
The device should be kept out of the reach of children/pets. When not in use, store
the device in a dry room and protect it against extreme moisture, heat, lint, dust and
direct sunlight. Never place any heavy objects on the thermometer body.
Do not throw batteries into fire.
Only use recommended batteries.Do not use rechargeable batteries.
This thermometer does not replace a hospital diagnosis.
Do not drop, disassemble or modify the device.
Do not use this device if you think it is damaged or notice anything unusual.
This device comprises sensitive components and must be treated with caution.
Observe the storage and operating conditions described in the ‘Technical
Specifications’ section.
Not servicing/maintenance while the thermometer is in use.
When using, shall not touch battery and the patient simultaneously.
Do not use the device if it is damaged/ degraded/loosened in any way. The continuous
use of a damaged unit may cause injury, improper results,or serious danger.
Based on the current science and technology, other potential allergic reactions are
unknown.
This equipment needs to be installed and put into service in accordance with the
information provided in the ACCOMPANYING DOCUMENTS.
OVERVIEW
Intended Use
The HoMedics Non-Contact Infrared Body Thermometers are designed to be used for
intermittent measurement and monitoring of human body temperature by consumers in
the home setting and primary care setting as screening tool.
Description of Non-Contact Infrared Body Thermometer
• Device principle and introduction

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• The HoMedics Non-Contact Infrared Body Thermometer is a hand-held, reusable,
battery operated device, which can measure human body temperature on forehead,
the skin temperature on one’s forehead.
• The operation principle is based on Infrared Sensor technology. The IR sensor can
output dierent signal when measuring dierent object temperature or in dierent
ambient temperature, and the ASIC can turn the signal from IR Sensor to a digital
value and display it on the LCD.
• Description on Controls, Indicators, and Symbols
1. IR sensor
2. Liquid crystal display (LCD)
3. MODE button
4. MEMO button
5. ON/scan button
6. Battery cover
7. Surface mode
8. Body mode
9. Data indicator
10. Indicator of measurement results
11. Low Battery indicator
12. Voice on/o indicator
13. Memory number
14. Fahrenheit
15. Celcius
16. Memory indicator
Figure 1: Non-Contact Infrared Thermometer
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THERMOMETER APPLICATIONS
Thermometer
Model Number Thermometer Style Adult Pediatric
Ear Forehead Ear Forehead
HTD8816C
TE-350-EU
Non-Contact Infrared Body
Thermometers ü ü
EQUIPMENT SYMBOLS
Warning Restriction of Hazardous Substances
Non-sterile packaging Batch code
Refer to operating instructions Compliance with WEEE Standard
Operating Temperature DO NOT THROW AWAY
Intended for multiple use
Operating Humidity Operating atmospheric pressure
This device compiles with Part 15
of FCC (Federal Communications
Commission) Rules.
Indicates this device is in compliance
with MDD 93/42/EEC. 0598 is the
Notified Body Number
Manufacturer Authorized Representative in the
European community
Recyclable Serial number
IP22: The first number 2: Protected against solid foreign objects of Ф12.5 mm and
greater. The second number: Protected against vertically falling water drops when
enclosure
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TECHNICAL SPECIFICATIONS
Measurement unit °C/°F
Operating mode Adjusted mode (Body mode)
Direct mode (surface mode)
Reference Body Site Axillary
Rated output range Body mode:
34.0 - 43.0°C / 93.2 - 109.4°F
Surface mode:
0 - 100.0°C / 32 - 212°F
Output range Body mode:
34.0 - 43.0°C / 93.2 - 109.4°F
Surface mode:
0 - 100.0°C / 32 - 212°F
Laboratory Accuracy Body mode:
34.0 - 34.9°C: ± 0.3°C / 93.2 - 94.8°F: ± 0.5°F
35.0 - 42.0°C: ± 0.2°C / 95.0 - 107.6°F: ± 0.4°F
42.1 - 43.0°C: ± 0.3°C / 107.8 - 109.4°F: ± 0.5°F
Surface mode:
± 2°C / ± 3.6°F
Display Resolution 0.1°C/0.1°F
Three-colour Backlight
(Colour Alarm)
35.5 - 37.3°C / 95.9 - 99.1°F: Green (Normal Temperature)
37.4 - 38.0°C (Alarm point) / 99.3 - 100.4°F: Yellow (Slight Fever)
38.1 - 43.0°C / 100.6 - 109.4°F: Red (High Fever)
Note: 1. Surface mode is always with Green backlight
2. In body mode 34.0-35.4°C is with green backlight
Auto Power O Time ≤18s
Measuring Time ≤ 2s
Measuring Distance 1 - 5cm (0.4 - 2 in)
Memories 50

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Power Supply Requirements
Batteries 2 x 1.5V (AAA) Alkaline battery (IEC Type LR03)
Adaptable Range 2.6V - 3.6V
Environmental
Operating Condition Operating Temperature:
15 - 40°C (59 - 104°F)
Relative Humidity:
≤ 85%
Atmospheric pressure:
70-106Kpa
Transport and Storage
Condition
Storage Temperature:
-20 - 55°C (-4 - 131°F)
Relative Humidity:
≤ 93%
Atmospheric pressure:
70-106Kpa
Dimension and Weighting
Weight (without batteries) 80g
Size L:122mm X W:96mm X H:42mm
Compliance
Item Compliant with
Equipment classification Safety Standards:
EN 60601-1: 2006+A1:2013, EN 60601-1-2: 2015
Type of protection Internally powered equipment (on battery power)
Degree of protection Non-Applied part
Front panel and case labelling EN ISO15223-1:2016
Temperature EN ISO80601-2-56:2017
Home healthcare environment EN 60601-1-11:2015

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Calculated values of the indicators according to ISO 80601-2-56
Indicators Calculated value
Clinical bias, rcb -0.027
Standard deviation, σj0.14
Limits of agreement, LA 0.26
Clinical repeatability, σr0.07
Note: the above value is calculated from clinical data of HTD8818A.
Safety classification of ME EQUIPMENT
Protection against electric shock Internally powered ME equipment
Applied part Non-Applied part
Protection against harmful ingress of water
or particulate matter
IP22
Mode of operation Continuous operation
Note: Not intended to be sterilized. Not for use in an OXYGEN RICH ENVIRONMENT.

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• When the ambient temperature of the thermometer changes too much, such as
moving the Thermometer from one place of lower temperature to another place of
higher temperature,allow the thermometer to remain in a room for 30 minutes where
the temperature is between 15°C to 40°C.
• The ambient temperature around the test person should be stable, should keep away
from the larger flow fan, air-conditioning vents and so on.
• When people moving from one place of lower temperature to another place of higher
temperature,should at least remain in the test environment more than 5 minutes, to
be consistent with the ambient temperature after the re-measurement.
OPERATION
Battery installation
Caution: The Non-Contact Infrared Body Thermometer does not operate with dead
batteries or external power sources.Install new batteries.
1. Slide the battery door downward, toward the bottom of the Non-Contact Infrared
Body Thermometer, and remove the battery access door;
2. Insert two pieces AAA size batteries according to the “+” and “-”;
3. Close the battery cover.
How to operate
Before applying the Thermometer, be sure to read and understand all warnings listed of
the instructions before use.
• The thermometer is aligned with the middle of the forehead to measure body
temperature between the eyebrows above and keep the vertical distance,press the
On/scan button, temperature will display immediately,see figure 2.
401cm-5cm
Figure 2: Measuring position and distance

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• Wait at least 1 second for the next measurement. If the continuous measurement
of five times, it is recommended to wait at least 30 seconds and then continue
measurement.
• You cannot use the thermometer in place where the sun is strong.
• If for some reason the forehead temperature measurement is low, try measurement
behind the ears. See figure 3.
Figure 3: Align behind the ears to measurement
GENERAL SET UP AND USE
Start measuring
1. Turn on the thermometer by pressing the On/scan button. The thermometer will
perform self-test with all segments displayed for 2 seconds.
2. Align the thermometer with the forehead, keeping the recommended distance,
and then press the ON/scan button to start the measurement. Data reading will
be displayed.
Note:
1. After measurement you will hear a “beep beep beep” three times which means
that the measurement is complete. The temperature is displayed on the LCD.
The LCD backlight colour will change red, green or yellow according to the
measurement. Green means Normal Temperature (35.5-37.3°C / 95.9-99.1°F)
ready for next measurement. Yellow means Slight FeverWarning (37.4-38.0°C /
99.3-100.4°F) Please pay attention to body temperature. Red means High Fever
(38.1-43.0°C / 100.6-109.4°F) Please take action to cool down or go to the doctor.
2. To ensure the accuracy of the measurement, wait at least 30 seconds after 5
consecutive measurements.
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1cm-5cm

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Mode conversion
• When the device is running, pressing the MODE button to cycle conversion between
“body” mode and “surface” mode.
• “Body” mode is used for measuring human body temperature, the “surface “ mode is
used to measure the surface temperature. (The factory default is “body” mode)
Recalling and Erasing Memory Data
The last temperature taken before the thermometer powers o is stored in memory, up
to 50.
1. In the boot or shutdown state, short press the MEMO button to view the history of
measured values.
2. An empty memory cell shows “---°C” or “---°F”.
3. Temperature readings can be stored in memory. Up to 50 temperature readings can
be stored into the memory cells and automatically overwrite historical data.
4. In boot mode, press the MEMO button until the LCD display “CLR”, which means that
all stored data is cleared completely.
Parameter settings
As below step:
1. Unit Set-F1
Under the boot mode, long press the “MODE” button to enter F1, press the “MODE”
or “MEMO”button to switch Celsius and Fahrenheit temperature units, press the On/
Scan button to confirm the unit settings (factory default is Celsius).
2. Fever alert set-F2
Under F1 state, press ON/scan button to enter the F2, press the “MEMO” button to
decrease 0.1°C, press the “MODE” button plus 0.1°C, long press to accelerate the
speed of temperature regulation, and finally press the ON/scan button to save. (The
factory default is 38.1°C)
3. Prompt sound settings-F3
Under F2 state, short press ON/scan button to enter F3, press MODE button or
MEMO button to set voice switch, and press the ON/scan button to confirm the
settings. (The factory default is the voice Prompt to open).

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• Prompt sound settings ON/OFF function
Under the boot mode. Short press on/o button, at the same time press the “MODE”
button to take on or take o the Prompt sound function.
• Restore to factory setting function
Under the boot mode, short press on/o button, at the same time press the MEMO
button until LCD display “rst”. Two seconds later, former F1-F3 parameter back to
factory setting.

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TROUBLESHOOTING
Message Situation Solution
Temperature taken in not within Typical human
temperature range.
(34.0°C ~ 43.0°C or 93.2°F ~ 109.4°F).
Make sure the forehead thermometer is for
forehead measurement, not other human
body site.
Measured over the distance: 1-5cm (0.4-2in) Optimum measurement distance is 1cm
Incorrect test position. See figure 2 Measuring position and distance.
Subjects forehead hair, Antipyretic stickers, head
with sweat, etc.
Subjects sit quietly 5-10 minutes before
the test.
Some people’s body temperature is lower than the
general population. The main concern fever temperature
Operating temperature exceeds the range of
specified temperature.
Move to a room within the operating range
wait 30 minutes before taking temperature.
The screen flicker, automatic turn o. Replace battery or the product has been
damaged, needs repairs.
Battery capacity is too low.Taking
Temperature is not allowed. Install a new battery
Ambient temperature changes too fast Wait until the ambient temperature is stable.
1. Power is o.
2. Improper battery installation.
3. The battery is exhausted.
4. Display remains blank.
1. Press ON button again.
2. Check the battery polarity.
3. Replace with a new battery.
4. Contact the retailer or service center.
REPLACING THE BATTERY
1. Open and release battery cover following indicator on the surface of battery cover.
Before changing the battery be sure the thermometer is already turned o.
2. Remove the battery and replace with 2 new type AAA batteries,Make sure to align
properly as indicated inside the battery cover.
3. Slide the battery cover back in until it snaps in place.
Do not dispose of used batteries in household waste. Take them to special local
collection sites.
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4. If the thermometer appears frozen after changing the batteries, remove batteries,
wait 30 seconds and replace batteries again.
WARNING
Do not recharge, disassemble or dispose of in fire.
1. The typical service life of the new and unused batteries is 2000 measurements for
the operation time is 18s.
2. Only use the recommended batteries, do not recharge non-rechargeable batteries
and do not burn them.
3. Remove the batteries if the thermometer is not to be used for a long period.
CLEANING, CARE AND STORAGE
• The lens is very delicate.
• It is very important to protect the lens from dirt and damage.
• Use a clean, soft cloth to clean the surface of the device and LCD. Do not use solvents
or immerse the device into water or other liquids.
• Always keep the thermometer within the storage temperature range (- 20°C to 55°C
or – 4°F to 131°F) and humidity range (≤93% non-condensing).
• It is recommended to store the thermometer in a dry location free from dust. Do
not expose the thermometer to direct sunlight, high temperature/ humidity or any
extreme environment, otherwise the function will be reduced.
• When the ambient temperature of the thermometer changes too much, such as
moving the thermometer from one place of lower temperature to another place of
higher temperature,allow the thermometer to remain in a room for 30 minutes where
the temperature is between 15°C to 40°C.
DISPOSAL
• Used batteries should not be disposed of in the household rubbish. Used Batteries
should be deposited at a collection point.
• At the end of its life, the appliance should not be disposed of in household rubbish.
• Enquire about the options for environment-friendly and appropriate disposal. Take
local regulations into account.

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WARRANTY
Our company warrants Non-Contact Infrared Body Thermometer at the time of its original
purchase and for the subsequence time period of 2 years.
The warranty does not cover the followings:
• The device series number label is torn o or cannot be recognized.
• Damage to the device resulting from misconnection with other devices.
• Damage to the device resulting from accidents.
• Changes performed by users without the prior written authorization of the company.
• Batteries and packaging are not covered under warranty
When asked to provide warranty service, you must have a purchase date and purchase
stamp dealers (including dealers name and address) of the warranty card. Be sure to
ask the dealer to purchase this product signature on the warranty card. When asked to
provide warranty service, please put the product to get our distribution points for repair.
Products outside the warranty expires, will be charged accordingly.
Note:
1. If you have any problems with this device,such as setting up, maintaining or
using, please contact with SERVICE PERSONNEL of FKA Brands Ltd. Don’t open or
repair the device by yourself.
2. Please report to FKA Brands Ltd if any unexpected operation or events occur.
3. Calibration needed to ensure proper function for every two years or after device
impact.
4. The patient is an intended operator. The patient can measure and change battery.
Under normal circumstances and maintain the device and its accessories
according to the user manual.
EMC DECLARATION
1. This equipment needs to be installed and put into service in accordance with
the information provided in the ACCOMPANYING DOCUMENTS; This product needs
special precautions regarding EMC and needs to be installed and put into service
according to the EMC information provided, and this unit can be aected by
portable and mobile RF communications equipment.

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2. * Caution: Do not use a mobile phone or other devices that emit electromagnetic
fields, near the unit. This may result in incorrect operation of the unit.
3. *Caution: This unit has been thoroughly tested and inspected to assure proper
performance and operation!
4. * Caution: this machine should not be used adjacent to or stacked with other
equipment and that if adjacent or stacked use is necessary, this machine should
be observed to verify normal operation in the configuration in which it will be
used.
Guidance and manufacturer’s declaration-electromagnetic emissions
The Non-Contact Infrared Body Thermometer is intended for use in the
electromagnetic environment specified below. The customer or the user of the
Thermometer should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment
guidance
RF emissions CISPR 11 Group 1
The Non-Contact Infrared Body
Thermometer 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 Non-Contact Infrared Body
Thermometer is suitable for
use in all establishments other
that domestic 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

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Guidance and manufacturer’s declaration-electromagnetic immunity
The Thermometer is intended for use in the electromagnetic environment specified below. The
customer or the user of the Thermometer 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
±6kV contact
±15kV air
±6kV
contact
±15kV air
Floor 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 air for input/
output lines
Not
applicable
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge IEC
61000-4-5
+/- 1kV line(s) to
line(s)
=/- 2kV line(s)
to earth
Not
applicable
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage
dips, short
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 use of the
Thermometer requires continued
operation during power mains
interruptions, it is recommended
that the Thermometer be powered
from an uninterruptible power supply
or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m 30 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.

Guidance and manufacturer’s declaration-electromagnetic immunity
The Thermometer is intended for use in the electromagnetic environment specified below. The
customer or the user of the Thermometer 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
3Vrms
150kHz to
80 MHz
10 V/m
80MHz to
2.5 GHz
Not
applicable
10 V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of the Thermometer, 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 Pis 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 aected by absorption and
reflection from structures, objects and people.
a. Field strengths from fixed transmitters, such as base stations from radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast andTV broadcast can not be predicted theoretic call 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 Thermometer is used exceeds the
applicable RF compliance level above, the Thermometer should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary,such as reorienting or relocating the Thermometer.
b. Over the frequency range 150kHz to 80MHz, field strengths should be less than 10 V/m.
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Recommended separation distances between portable and mobile RF communications equipment
and the Thermometer
The Thermometer is intended for use in an electromagnetic environment in which radiated
RF distances are controlled.The customer or the user of the Thermometer can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the Thermometer 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 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 metres (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
aected by absorption and reflection from structures, objects and people.