HoMedics HTD8216C Mode d'emploi

2 YEAR GUARANTEE

Model: HTD8216C

INFRARED

BODY

THERMOMETER

TE-300-EU 1

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FOREWORD

The 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 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:

FKA Brands Ltd, Somerhill Business Park, Five Oak Green Road,

Tonbridge, Kent TN11 0GP.

Customer Service: [email protected]

Share Info Consultant Service LLC Repräsentanbüro

Heerdter Lohweg 83, 40549 Düsseldorf

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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 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 Software Validation.

WARNING

Warnings are identiﬁed by the WARNING symbol shown above.

• The 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 and

ear. 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 35°C (59°F- 95°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 temperature, please select “body” mode or“ear” 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. Also the ear wax will lower

down the temperature. So please be sure use correct way in case of accuracy of

measurements.

• Some people are not suitable to use ear mode properly for oily ears or for other

reasons.

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, do 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.

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OVERVIEW

Intended Use

The HoMedics Infrared Body Thermometer is 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 Infrared Body Thermometer

Device principle and introduction

• The 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. Passive infrared probe

2. Cap

3. Start button

4. Liquid crystal display

(LCD)

5. Battery cover (MODE

button is behind the

battery cover)

1. Forehead mode

2. Ear mode

3. Surface mode

4. Measurement unit

5. Data indicator

6. Low Battery indicator

7. Indicator of

measurement result

8. Volume on/o indicator

9. Memory indicator

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THERMOMETER APPLICATIONS

Thermometer

Model Number Thermometer Style Adult Pediatric

Ear Forehead Ear Forehead

Model: HTD8216C

TE-300-EU 1 Infrared Body Thermometer ü ü ü ü

EQUIPMENT SYMBOLS

Warning Restriction of Hazardous Substances

Non-sterile packaging Batch code

Consult instructions for use 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

Type BF (Body Floating)

IP22: The ﬁrst number 2: Protected against solid foreign objects of Ф 12.5 mm and

greater. The second number: Protected against vertically falling water drops when

enclosure titled up to 15º.

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TECHNICAL SPECIFICATIONS

Measurement unit °C/°F

Operating mode Adjusted mode (Body mode)

Direct mode (surface mode)

Measuring site Forehead / Ear

Reference Body Site Axillary

Rated output range 35.0-42.0°C :±0.2°C / 95.0-107.6°F:±0.4°F

Output range Body mode: 34.0-42.9°C / 93.2-109.2°F

Surface mode: 0°C - 100.0°C / 32°F -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 - 42.9°C: ± 0.3°C / 107.8 - 109.2°F: ± 0.5°F

Surface mode:

± 2°C / ± 3.6°F

Display Resolution 0.1°C/0.1°F

Three-colour Backlight

(Colour Alarm) 34 - 37.3°C / 93.2 - 99.1°F: Green (Normal Temperature)

37.4 - 38.0°C (Alarm point) / 99.3 - 100.4°F: Yellow (Slight Fever)

38.1 - 42.9°C / 100.6 - 109.2°F: Red (High Fever)

Note: Colour Alarm is only for Body mode, Surface mode is always with

Green backlight.

Auto Power O Time ≤35s

Measuring Time ≤ 5s (under ear mode)

≤2S(under Forehead mode)

3-10s (under Forehead scan mode)

Memories 1

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Power Supply Requirements

Batteries 2 x 1.5V (AAA) Alkaline battery (IEC Type LR03)

Environmental

Operating Condition Operating Temperature:

15 - 35°C (59 - 95°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) 66g

Size L:154mm X W:34mm X H:52mm

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)

Front panel and case labelling EN ISO 15223-1:2016

Temperature EN ISO80601-2-56:2012

Home healthcare environment EN 60601-1-11:2015

Accessory name number

AAA battery 2

User manual 1

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Calculated values of the indicators according to ISO80601-2-56-2012

Ear mode:

Group A1 Group A2 Group B Group C

Bias 0.000 -0.097 -0.046 -0.060

Standard deviation 0.175 0.154 0.116 0.125

Limits of agreement 0.349 0.308 0.233 0.249

Clinical repeatability (for all groups) 0.057

Forehead mode:

Group A1 Group A2 Group B Group C

Bias -0.060 -0.083 -0.032 0.000

Standard deviation 0.170 0.144 0.139 0.120

Limits of agreement 0.340 0.288 0.278 0.239

Clinical repeatability (for all groups) 0.108

Forehead scan mode:

Group A1 Group A2 Group B Group C

Bias -0.015 -0.063 -0.068 -0.090

Standard deviation 0.173 0.167 0.135 0.125

Limits of agreement 0.345 0.334 0.269 0.250

Clinical repeatability (for all groups) 0.064

Safety classiﬁcation of ME EQUIPMENT

Protection against electric shock Internally powered ME equipment

Degree of protection Type BF - applied part (the probe)

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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OPERATION

Battery installation

Caution: The 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 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.

4. The product will not work without batteries installed.

5. Please obey the local laws and regulations to dispose of used batteries properly in

order to avoid environmental pollution.

6. If the thermometer will not be used regularly, remove the battery to prevent

possible damage due to chemical leakage.

7. Before using, check the appearance of the product for abnormalities, to ensure

that the product has not been dropped or sustained any external damage that

could aect its operation. If the product is damaged, do not use.

How to operate

• Forehead mode: Put on the probe cap and keep the thermometer aligned with

the middle of the forehead to measure body temperature (between or above the

eyebrows). Holding the product vertically, press the Start button - the temperature

display will immediately appear.

• Forehead scan mode: Put on the probe cap, keep the thermometer close to the

forehead and vertical, press and hold the Start button and move the thermometer

from left to right or from right to left for approximately 3-10 seconds. The maximum

temperature will be displayed on the screen.

• Please keep the forehead free of hair, perspiration, cap, scarf and etc during forehead

temperature measurement.

• Ear mode: Remove the cap and insert ear thermometer probe slightly into the ear

canal, then press the START button , measurement will be ﬁnished within 5 seconds.

• Please keep the ear canal and probe surface clean when taking ear temperature

measurement.

• You should remain in the test environment for at least 5 minutes, and measure after

the ambient temperature is in accordance with the environment.

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• If using a cold compress or other physical cooling methods, the forehead temperature

will be lower.

• 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 30 minutes, to

be consistent with the ambient temperature after the re-measurement.

• You cannot use the thermometer in place where the sun is strong.

• It is recommended that you test at least 3 times and select the result that appears

most often.

• When measuring body temperature, please select “ear “ mode or “forehead” mode; for

measurement of other objects, liquid ,food temperature, please select surface mode.

• If for some reason the forehead temperature is low, try to take a measurement behind

the ear or select ear mode to measure.

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START MEASURING

Ear temperature measurement

1. Turn on the thermometer by pressing the Start button. The thermometer will

perform self-test with all segments displayed for 2 seconds. See ﬁgure 3.

2. After full display over, you will hear “beep beep beep”, which means that the

self-test is complete. The last measured temperature will be displayed. If no data

is saved to memory, the display will indicate “----”. See ﬁgure 4.

3. When initialisation is complete, the memory symbol disappears and the unit

symbol starts ﬂashing, which means the measurement can be started. See ﬁgure

5.

4. If the person being measured is more than one years old, please pull the ear up

and back gently. If less than one year old, pull ear back gently.

5. Insert the thermometer probe slowly into the ear canal and press the START

button. The device will start measuring with a short “beep” once at the start,

then 2 - 5 seconds later. Finally 5 short “beeps” means measurement has been

completed, and the target value of the measured temperature will display on the

LCD. The LCD backlit colour will change to red, yellow or green. Green means the

Normal Temperature and ready for measurement . Yellow means Slight Fever.

Red indicates High Fever. Please kindly note that both yellow and red colour are

a warning.

Note: Colour Alarm is only for Body mode, Surface mode has a Green backlight.

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1. Turn on the thermometer by pressing the Start button. The thermometer will

perform self-test with all segments displayed for 2 seconds. See ﬁgure 6.

2. After full display over, you will hear “beep beep beep”, which means that the

self-test is complete. The last measured temperature will be displayed. If no data

is saved to memory, the display will indicate “----”. See ﬁgure 7.

3. Please note, if the screen shows this symbol instead of , remove the battery

cover and press the MODE button to switch to forehead mode. See ﬁgure 8.

4. After initialisation, the memory symbol “M” will disappear and the unit symbol

°C (or symbol °F) will start ﬂashing which means the device is ready to take a

temperature measurement.

5. Temperature scan method: keep the thermometer vertical and close to the

forehead. Press the Start button. The device will start measuring with a short

“beep” once at the start, then 3 - 10 seconds later. Finally a long “beep” or 5

short “beeps” means measurement has been completed, and the target value of

the measured temperature (maximum) will display on the LCD. The LCD backlit

colour will change to red, yellow or green. Green means the Normal Temperature

and ready for measurement . Yellow means Slight Fever. Red indicates High Fever.

Please kindly note that both yellow and red colour are a warning.

Mode conversion

The product will switch to ear mode if the cap is removed. When the cap is replaced,

forehead mode and surface mode can be switched between using the MODE button. ”ear

“ and “forehead” mode is used for measuring human body temperature, the “surface “

mode is used to measure the surface temperature. (The factory default is “body” mode).

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Forehead temperature measurement

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TROUBLESHOOTING

Message Situation Source or Solution

Temperature taken in is higher than typical human

temperature.

Body mode: detected target temperature

higher than 42.9°C

Surface mode : detected target temperature

higher than 100°C

Temperature taken in is lower than typical human

temperature.

Body mode: detected target temperature

lower than 34.0°C

Surface mode : detected target temperature

lower than 0°C

Operating temperature exceeds the range of

speciﬁed temperature. Environment temperature higher than 35°C or

lower than 15°C

Wrong function indicated System failure found when system

auto-checks, the screen ﬂickers, and device

automatically turns o.

Battery capacity is too low.

Taking temperature is not allowed. Install a new battery

Ambient temperature is unstable Wait until the ambient temperature is stable.

Please allow device to acclimatise for at least

30 minutes before using it.

Blank screen 1. Press ON button again.

2. Check the battery polarity.

3. Replace with a new battery.

The internal time from the ﬁrst

measurement to next measurement is less than 5

seconds under ear mode.

Please wait 5 seconds before taking next

measurement.

The measurement result is unvailable, because scan

is too fast under forehead scan mode, or position of

the device is not correct under ear mode.

1. Slow down the scan speed under

forehead scan mode.

2. Put the probe in the right position of ear

canal under ear mode.

Activate mode switch when taking a

measurement. Check if the cap is loose. Please make sure

the cap is loose if you take a measurement

from the forehead.

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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. Press the battery holder lock to release the batteries 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.

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.

CLEANING, CARE AND STORAGE

• The lens is very delicate.

• It is very important to protect the lens from dirt and damage.

• The Infrared probe is very delicate. Do not touch or use tools on it. It must be carefully

protected otherwise it will aect the accuracy of the measure.

• Use an alcohol cloth or 70%~75% alcohol wet cloth to clean the thermometer shell,

surface of the device and LCD. When the thermometer probe is dirty or used by

dierent people, please use alcohol swab or cotton swab moistened with 70%~75%

alcohol to clean and disinfect the probe’s surface of thermometer gently. 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).

• The device requires at least 30 minutes to warm up from the minimum storage

temperature between uses before it is ready for intended use.

• The device requires at least 30 minutes to cool down from the maximum storage

temperature between uses before it is ready for intended use.

• 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.

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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 35°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.

WARRANTY

Our company warrants 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 HoMedics Service Centre. Don’t open or repair the

device by yourself.

2. Please report to HoMedics if any unexpected operation or events occur.

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3. The thermometer is initially calibrated at the time of manufacture. If this

thermometer is used according to the user instructions, periodic re-adjustment

is not required. If at any time you question the accuracy of temperature

measurements, please contact us.

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.

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.

5. * The infrared body thermometer is suitable for hospitals except for near active

HF SURGICAL EQUIPMENT and the RF shielded room of an ME SYSTEM for magnetic

resonance imaging, where the intensity of EM DISTURBANCES is high.

6. * Performance of the infrared body thermometer such as measure accuracy,

information display would be lost or degraded due to EM DISTURBANCES.

7. * Caution: the EMISSIIONS characteristics of this equipment make it suitable for

use in hospitals and a residential environment (CISPR 11 Class B)

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Guidance and manufacturer’s declaration-electromagnetic emissions

The 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

RF emissions CISPR 11 Group 1

RF emissions CISPR 11 Class B

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

Electrostatic discharge (ESD)

IEC 61000-4-2 ±8kV contact

±2, ±4, ±8, ±15 kV air ±8kV contact

±2, ±4, ±8, ±15, kV air

Electrical fast transient/burst

IEC 61000-4-4

The input a.c. power ports: ±2 KV

The input d.c. power ports: ±2 KV

Signal input/output ports: ±1 KV Not applicable

Surge IEC 61000-4-5 Input power ports: +0.5, +1.0 KV

Signal input/output:+2.0 KV Not applicable

Voltage dips, short interruptions

and voltage variations on power

supply input lines

IEC 61000-4-11

0.5 cycles for > 95% (sync angle

(degrees):0, 45, 90, 135, 180,225,

270, 315)

1 cycles for >95% UT (sync

angle

(degrees):0)

25 (50Hz)/30 (60Hz) cycles for

30% U T (sync angle

(degrees):0)

Not applicable

Voltage interruption

IEC 61000-4-11

250 (50Hz)/300 (60Hz) cycles

for >95% UT (sync angle

(degrees):0)

Power frequency (50/60 Hz)

magnetic ﬁeld IEC 61000-4-8 30 A/m 30 A/m

NOTE UT is the a.c. mains voltage prior to application of the test level.

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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

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3Vrms

150kHz to 80 MHz

Professional healthcare

environment: 3 V/m

Home healthcare environment

10 V/m 80MHz to 2.5 GHz

Not applicable

Professional healthcare

environment: 3 V/m

Home healthcare environment

10 V/m 80MHz - 2700 MHz

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 and TV 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 3 V/m.

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HoMedics HTD8216C Mode d'emploi

HoMedics HTD8216C Mode d'emploi

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