FORA IR21 Ear/Forehead Thermometer Owner’s Manual

June 6, 2024
FORA

FORA IR21 Ear- Forehead Thermometer-- logo

IR21 / IR20
Ear/Forehead Thermometer /
Ear Thermometer
Owner’s ManualFORA IR21 Ear- Forehead Thermometer--
Thermometer

IMPORTANT SAFETY INSTRUCTIONS

READ THIS BEFORE USING
The following basic safety precautions should always be taken.

  1. Close supervision is necessary when the thermometer is used by, on, or near children, handicapped persons or invalids.
  2. Use the thermometer only for the intended use described in this manual.
  3. Do not use the thermometer if it is not working properly, or if it has suffered any damage.
  4. Do not use accessories which are not supplied or recommended by the manufacturer.

KEEP THESE INSTRUCTIONS IN A SAFE PLACE

Cautions and Warnings

  • As with any thermometer, proper technique is crucial to getting accurate temperature readings. Please read this manual thoroughly and carefully before using.
  • Always store the thermometer in a cool and dry place: temperatures between -20°C to 60°C (-4°F to 140°F) relative humidity less than 95%. Avoid direct sunlight.
  • Avoid dropping the thermometer from a height or strongly hitting it with a hard object.
  • Do not touch the probe lens.
  • Do not disassemble the thermometer.
  • Basic safety precautions should always be observed, especially when the thermometer is used on or near children and disabled persons.
  • This thermometer is not intended to be a substitution for consultation with your physician.
  • The skin/surface scan temperature serves as a reference only. It cannot be a judgment on fever.
  • Temperature of left and right ear may differ. Always measure using same ear.
  • Only use the probe cover for infrared FORA IR20 ear thermometer.
  • For proper hygiene, do not share probe cover. Damaged probe cover may result in error display.
  • If you experience any serious incident that occurred in relation to the use of this product, please report it to the manufacturer and the competent authority of medical devices in your country.
  • A serious incident means any incident that directly or indirectly led, might have led, or might lead to any of the following:
    (a) the death of a patient, user, or other people,
    (b) the temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health,
    (c) a serious public health threat.

Restrictions of Use

This thermometer is clinically proven to produce accurate temperature measurements. However, please be advised if you have the following situations:
The accuracy cannot be ensured for a person who has deformity in the ear such that the thermometer probe can not be properly inserted into the ear canal.

  • The accuracy cannot be ensured when blood or drainage is found in the ear canal.
  • Take temperature from the other ear if ear drops or medications have been placed in an ear.
  • For a person who wears ear plug or hearing aid, remove the device and wait for 15 minutes before taking temperature.

NOTE
Never try to clean inside the ears. You may accidentally damage the eardrum or its surrounding tissues. Remove excess earwax only when you can reach it with a clean cloth. Consult a physician if you suspect the presence of excess earwax.

Introduction

Thank you for choosing FORA IR21 ear/forehead thermometer. This innovative medical device relies on advanced infrared (IR) technology to measure temperature instantly and accurately through two convenient sites: the ear canal and the surface of the skin over the temple. FORA IR21 ear/forehead thermometer is an elegantly designed infrared thermometer meant for your family.

Thank you for choosing FORA IR20 ear thermometer. This innovative medical device relies on on advanced infrared (IR) technology to measure temperature instantly FORA IR20 ear thermometer is an elegantly designed infrared thermometer meant for your family.

Intended use

FORA IR21 ear/forehead thermometer is intended for the intermittent measurement and monitoring of human body temperature from ear canal or skin/surface scan. The device is intended for use by people of all ages in the home.
FORA IR20 ear thermometer is intended for the intermittent measurement and monitoring of human body temperature from ear canal. The device is intended for use by people of all ages in the home.

How does it work
The thermometer measures the infrared heat generated by the eardrum and its surrounding tissue, or by the surface of the skin over the temporal artery. The thermometer then converts it into a temperature value shown on LCD.
NOTE
The thermometer does not emit any infrared signal.

Thermometer Parts

FORA IR21 Ear- Forehead Thermometer--
ThermometerThermometer

1. Probe cover 6. Data port
2. Night light (FORA IR21) /Probe cover ejection button (FORA IR20) 7.

Probe lens
3. On/Memory button| 8. Probe
4. Sticker| 9. Scan button
5. Battery cover| 10. Probe cover detector (FORA IR20)

LCD Screen

FORA IR21 Ear- Forehead Thermometer-- LCD Screen

1. Ear temperatureindicator 6. Record numbers
2. Skin/Surface temperature indicator 7. Low bettery indicator
3. Temperature scanning in progress 8. Temperature unit
4. Temperature display 9. Communication symbol
5. Memory mode 10. Non-probe cover warning (FORA IR20)

Replacing the Battery

The thermometer comes with two 1.5V AAA alkaline batteries. Replace it when “ ” appears. Please follow the steps to replace new batteries.
Step 1
Remove the battery cover.
FORA IR21 Ear- Forehead Thermometer-- Step 3 Step 2
Place the new battery in the battery compartment and press it in until the battery is firmly secured.
FORA IR21 Ear- Forehead Thermometer-- Step 2

Step 3
Reattach the battery cover.FORA IR21 Ear- Forehead Thermometer-- Step
1

NOTE

  • Although the thermometer works when “ ” appears, we still recommend that you change the battery to obtain an accurate result.
  • Remove the battery if stored for a long period of time.
  • The battery should be kept out of reach of children. If they are swallowed, promptly see a doctor for help.

About Normal Body Temperature & Fever

Body temperature can vary from one individual/person to next. It also varies by location on the body and different time of the day. Below shows the statistical normal ranges from different sites. Please keep in mind that temperatures measured from different sites, even at the same time, should not be directly compared.
Fever indicates that the body temperature is higher than normal. This symptom may be potentially caused by infection, overdressing or immunization. Some people may not experience fever even when they are ill. These include, but are not limited to, infants younger than 3 months old, persons with compromised immune systems, persons taking antibiotics, steroids or antipyretics (aspirin, ibuprofen, acetaminophen), or persons with certain chronic illnesses. Please consult your physician when you feel ill even if you do not have fever.

*Table 11  Body Site Normal Temperature Range**

Oral 0.6°C (1°F) or more above or below 37°C (98.6°F)
Rectal/ear 0.3°C to 0.6°C (0.5°F to 1°F) higher than oral temperature

Axillary
(underarm)| 0.3°C to 0.6°C (0.5°F to 1°F) lower than oral temperature

*1. Body Temperature at WebMD;
http://firstaid.webmd.com/body-temperature retrieved at 2010 Jan 7.

Using the Device

As an Ear Thermometer (IR21)

Step 1
Remove the probe cover first.
FORA IR21 Ear- Forehead Thermometer-- cover firstStep 2
Turn on the thermometer.
Press and release the On / Memory button. When ready, the thermometer displays the last measurement.FORA IR21 Ear- Forehead Thermometer-- Step
5x

Step 3
Gently fit the probe into the ear canal.FORA IR21 Ear- Forehead Thermometer
--Gently fit

Step 4
Press and release the Scan button.
Do not remove the thermometer until it beeps.
FORA IR21 Ear- Forehead Thermometer-- Press and
release Step 5
Read the result. “ ” is shown together with a temperature value.
FORA IR21 Ear- Forehead Thermometer-- covelMby
pufflling

NOTE

  • The thermometer does not require any costly lens filters.

  • Turn off the thermometer by pressing On / Memory button twice. 
    It will automatically turn off if left idle for 3 minutes.

  • If you need to take another reading, wait “ ” flashing before taking another measurement.

Hints on Taking Ear Temperture
As with other of thermometer, you may observe slight variations in consecutive measurements.
It is recommended that you take 3 temperature readings and use the highest one for the following situations:

  • Infants younger than 3 months old.
  • Children younger than 3 years old and who have a compromised immune system and the presence /absence of fever is critical.
  • When you are learning to use the thermometer.

Do not take a reading while eating and /or talking.
Wait 30 minutes after any of the following situations before taking a measurement:

  • When you have your ear covered.
  • After exercising, swimming, or taking a bath. When expose to extreme temperature.
    To take accurate readings, the ear must be free from excess earwax build-up.

Replacing Probe Cover (IR20)

Step 1
Check the probe cover is clean and new.
FORA IR21 Ear- Forehead Thermometer-- covkle Step 2
Attach new probe cover into the probe.
Now, you can start to test your ear temperature.
FORA IR21 Ear- Forehead Thermometer-- covelr fprobe

NOTE

  • If a probe cover is not attached on the probe, LCD will show “ ” until a new probe cover is firmly attached to the probe.
  • The used probe cover should be removed after each measurement by a clean and new probe cover to ensure accuracy reading.
  • For hygiene use, attach a new probe cover each time and do not touch its tip.

Taking Ear Temperature (IR20)

Step 1
Make sure probe cover is firmly attached to the probe.FORA IR21 Ear-
Forehead Thermometer-- covelr fprobe

Step 2
Press and release the On / Memory button to turn on the thermometer. When ready, the thermometer displays the last measurement.
FORA IR21 Ear- Forehead Thermometer-- covelMemory Step 3
Stretch your ear canal by pulling your ear backwards and upwards and carefully insert the thermometer into the ear.
FORA IR21 Ear- Forehead Thermometer-- covelMby pulling Step 4
Press and release the Scan button. Do not remove the thermometer until it beeps.
FORA IR21 Ear- Forehead Thermometer-- covelMby
puffglingStep 5
Read the result.
“ ” is shown together with a temperature value.
FORA IR21 Ear- Forehead Thermometer-- covelMby
pufflling Step 6
Discard used probe cover into trash by pressing probe cover ejection button.
FORA IR21 Ear- Forehead Thermometer-- covelMby
pullffing NOTE
Turn off the thermometer by pressing On / Memory button twice. It will automatically turn off if left idle for 3 minutes.

As a Skin/Surface Scan Thermometer (IR21)

Step 1
Make sure the probe cover is capped.
FORA IR21 Ear- Forehead Thermometer-- covelMby
puffjgling Step 2
Turn on the thermometer.
Press and release the On / Memory button. The thermometer displays the last measurement.
FORA IR21 Ear- Forehead Thermometer-- covelMby
puffgljing

Step 3
Put the probe on the temple. Press and hold the Scan button. Make sure the probe is flat on the temple, not at an angle.
FORA IR21 Ear- Forehead Thermometer-- LCD Sc

Step 4
Read the result.
Release the button and read the result. “ ” is shown together with a temperature value and beeps.
FORA IR21 Ear- Forehead Thermometer-- covelMby pStep 4

NOTE

  • As the skin/surface scan temperature is likely to be affected by sweat, oil and the surroundings, the reading shall be taken as a reference only.
  • If the probe is placed at an angle on the skin/surface scan, the reading will be affected by surrounding temperature.
  • You can perform a skin/surface scan from 3 cm away.
  • Turn off the thermometer by pressing On / Memory button twice. Or leave for 3 minutes after a temperature measurement, the thermometer will automatically turn off.
  • If you need to take another reading, for the flashing “ ” flashing before taking another measurement.

Recalling the Memory

Your thermometer stores 10 recent readings in the memory.

Step 1
Be sure the thermometer is OFF before recalling this memory.
FORA IR21 Ear- Forehead Thermometer-- memory Step 2
Press the On /Memory button to turn on the thermometer.
FORA IR21 Ear- Forehead Thermometer-- thermometer Step 3
Press the On /Memory button for 3 seconds to enter memory mode.
FORA IR21 Ear- Forehead Thermometer-- LCD ScrejEach time you press the On / Memory button, a result will be displayed in the order of dates (latest result shown first), together with “ ” and number ( from 1 to 10 ).
When the memory is full, the oldest result is deleted as the new one added. When the last record is displayed in the LCD, press On / Memory button again to return the
first record.

Step 4
Exit the memory.
Press the Scan button and LCD will show latest results with flashing “ ” . Then press On/Memory button again and LCD will show “ OFF ” to exit memory.
NOTE
When using the thermometer for the first time, the first memory result will display 0.0°C. It indicates that there are no test results in memory.

Viewing Results on a Personal Computer

Results in memory can be transmitted to the personal computer by either cable or wireless connection for FORA IR21c / IR20c and FORA IR21b / IR20b, respectively. Accessories needed to activate this function are:

  • Health Care Software System: a software downloaded from ForaCare’s website (www.foracare.ch)
  • Interface Cable: an optional accessory for FORA IR21c / IR20c.
  • Bluetooth Adapter: an optional accessory for FORA IR21b / IR20b. Please contact your local customer service for above accessories.

Transmitting data via Cable
(FORA IR21c / IR20c)
Step 1 Install Software
Install Health Care System Software on your computer by following the instructions provides on ForaCare’s website.
Step 2 Connect to Personal Computer
Connect the interface cable to a serial port on the back of your computer. With the thermometer turn off, connect the interface cable to the data port located at the bottom of the thermometer. Then “ PCL ” will appear in the display, indicating that the thermometer is ready to transmit data.
Step 3 Transmit Data
Follow the instructions provided in the software to transmit data. Results transmitted will include date and time. Remove the cable and the thermometer will automatically turn off.

Transmitting data via Bluetooth Adapter (FORA IR21b / IR20b)
Step 1
Install Health Care System Software on your computer by following the instructions provided on ForaCare’s website.
Step 2
Install Bluetooth Adapter Software.
Step 3
Reset FORA IR21b / IR20b thermometer.
Step 4
Pair FORA IR21b / IR20b thermometer with your computer. Select FORA IR21b / IR20b thermometer device code: “FORA-Device” and key in the Bluetooth passkey (PIN): 111111 for pairing.
Step 5
Connect Bluetooth Serial Port Service: Right click on icon “FORA-Device” and select “connect” and “Bluetooth Serial Port Service” for connection. The results will be transmitted automatically to your computer once you finish taking the temperature. In the meanwhile, the communication symbol on the thermometer will flash. If you are using the Bluetooth Adapter provided by ForaCare Suisse AG, please follow the installation guide “Bluetooth Easy Card” within the package.FORA IR21 Ear- Forehead Thermometer--
SBluetooth

Bluetooth Indicator Description
Flash fast The meter is searching the device of Bluetooth signal.
Flash slowly The meter is pairing with the device of Bluetooth.
Lit solid The meter is transmitting the data now the connection is completed.

NOTE

  • While the thermometer is connected to the PC or the server, it is unable to perform a test.
  • We recommend that you use bluetooth adaptor provided by ForaCare Suisse AG.

Care & Cleaning

  • Keep the probe clean, as earwax and grease build up may affect the measurement.
    FORA IR21 Ear- Forehead Thermometer-- with a cotton

  • The probe tip is the most delicate part of the thermometer. It has to be clean and intact to ensure accurate readings. Very gently wipe the surface with a cotton swab.

  • The body of the thermometer is not water-resistant. Never put the thermometer under a running tap or submerge it into water. Use a soft and dry cloth to clean it. Do not use abrasive cleaners.

  • Store the thermometer in a cool and dry location. Free from dust and away from direct sunlight.

Fever Indicator

When the measurement is equal or over 38°C (100.4°F), red backlight is shown together with the result. The red backlight will last for 3 seconds and turn off.

Troubleshooting

The table below shows problems you may encounter. All error messages below would be shown together with orange backlight. Please follow “what to do” to resolve problems. If the problem still exists, please call your local dealer for help.

Message What it means What to do
Room temperature is below 10°C. Put the thermometer under operating

temperature range
of 10°C to 40°C (50°F to 104°F).
| Room temperature is above 40°C.| Put the thermometer under operating temperature range
of 10°C to 40°C (50°F to 104°F).
| You don’t use probe cover while measuring ear temperature.| Please place probe cover into probe again.
| Problem with the thermometer.| Review the instructions and re-start the measurement
procedure. If the above steps do not work.
Please contact the dealer.
| Battery is low and “ ” appears on LCD.| Please replace batteries as soon as possible.
| Appears when the batteries can’t provide
enough power for a test.| Please replace new batteries.
| Temperature measurement falls outside the displayed temperature range: (ear temperature range from 32°C to 43°C. skin/surface scan temperature range from 22°C to 44°C.)| Please follow this manual to take a reading again.

Specifications

Dimensions| 162.2mm (L) x 32.4mm (W) x
38.0mm (H)  (FORA IR21)
160.5mm (L)  x 32.5mm (W) x
45.9mm (H)  (FORA IR20)
---|---
Weight| 110.0g (include 2 x1.5V AAA batteries)  (FORA IR21)
105.5g (include 2 x1.5V AAA batteries)   (FORA IR20)
Battery| 2 x 1.5V AAA alkaline batteries
External output| RS-232 / USB / Bluetooth
Displayed temperature range| 32°C to 43°C (89.6°F to 109.4°F)
Display resolution| 0.1°C / 0.1°F
Accuracy| Meet the accuracy requirement
specified in ASTM E1965-98
♦ ±0.2°C (±0.4°F) for the range of 36.0°C to 39.0°C (96.8°F to 102.2°F)
♦ ±0.3°C (±0.5°F) from 34.0°C to 35.9°C (93.2°F to 96.6°F) and from 39.1°C to 42.2°C (102.4°F to 108.0°F)
Temperature unit| °C / °F
Operating temperature range| 10°C to 40°C (50°F to 104°F)
Operating humidity| 95% RH or less
Storage temperature range| -20°C to 60°C (-4°F to 140°F)
---|---
Storage humidity| 95% RH or less
Memory capacity| 10 measurements

The specifications may be changed without prior notice.
This device has been tested to meet the electrical and safety requirements of: ASTM E1965-98, EN 12470-5, EN 60601-1- 2:2007/AC:2010, EN 60601-1-4:1996, EN 60601-1- 6:2010, EN 301 489-17, EN 300 328.

Symbol Information

Symbol Referent
Consult instructions for use
Manufacturer
Serial number
Caution, consult accompanying documents
Type BF Equipment
CE Mark
Disposal of waste equipment
Storage/Transportation temperature limitation
--- ---
Storage/ Transportation humidity limitation
Authorised representative in the EuropeanUnion
Medical Device

Meter Disposal

The used meter should be treated as contaminated and may carry a risk of infection during measurement. The batteries in this used meter should be removed and the meter should be disposed in accordance with local regulations. The meter falls outside the scope of the European Directive 2002/96/ EC- Directive on waste electrical and electronic equipment (WEEE).

WARRANTY TERMS AND CONDITIONS

With respect to disposable products, ForaCare Suisse warrants to the original purchaser that, at time of delivery, each standard product manufactured by ForaCare Suisse shall be free of defects in material and workmanship and, when used for the purposes and indications described on the labeling, is fit for the purposes and indications described on the labeling. All warranties for a product shall expire as of the product expiration date, or if none, after two (2) year from the original date of purchase, as long as it has not been modified, altered, or misused. ForaCare Suisse warranty hereunder shall not apply if:

(i) a product is not used in accordance with its instructions or if it is used for a purpose not indicated on the labeling; (ii) any repairs, alterations or other work has been performed by the buyer or others on such item, other than work performed with ForaCare Suisse’s authorisation and according to its approved procedures; or (iii) the alleged defect is a result of abuse, misuse, improper maintenance, accident or the negligence of any party other than ForaCare Suisse. The warranty set forth herein is conditioned upon proper storage, installation, use and maintenance in accordance with applicable written recommendations of ForaCare Suisse. The warranty furnished hereunder does not extend to damage items purchased hereunder resulting in whole or in part from the use of components, accessories, parts or supplies not furnished by ForaCare Suisse.

Warning: Medical electrical equipment needs special precautions regarding EMC and needs to be installed according to the EMC information provided. Careful consideration of this information is essential when stacking or collocating equipment and when routing cables and accessories.
Warning: RF mobile communications equipment can affect medical electrical equipment.

Recommended separation distance between portable and mobile RF communications equipment and FORA IR20/1R21


FORA IR20/1R21 is intended for use in an electromagnetic environment (for home healthcare and professional healthcare) in which radiated RF disturbances are controlled. The customer or the user of FORA IR20/1R21 can help prevent electromagnetic interference by maintaining a minimum distance between the portable and mobile RF communications equipment (transmitters) and FORA IR20/IR21 as recommended below, depending on 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 NIP

| 80 MHz to 800 MHz
d =1,2 NIP|

800 MHz to 2,7 GHz
d =2,3VP

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) depending on 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 to all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Manufacturer’s declaration-electromagnetic emissions

FORA IR20/IR21 is intended for use in the electromagnetic environment (for home healthcare and professional healthcare) specified below.
The customer or the user of FORA IR20/IR21 should assure that it is used in such an environment.
Emission test| Compliance| Electromagnetic environment-guidance
(for home healthcare and professional healthcare)
RF emissions CISPR 11| Group 1| FORA IR20/IR21 uses RF energy only for internal use. Therefore, its RF emissions are very
low and are not likely to cause any interference from nearby electronic equipment.
RF emissions CISPR 11| Not applicable| FORA IR20/IR21 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| Class B
Voltage fluctuations/flicker emissions
IEC 61000-3-3| Not applicable
Manufacturer’s declaration-electromagnetic immunity

FORA IR20/IR21 is intended for use in the electromagnetic environment (for home healthcare and professional healthcare) specified below. The customer or the user of FORAIR20/1R21 should assure that it is used in the environment specified below.

Immunity test

| IEC 60601 test level| Compliance level|

Electromagnetic environment guidance
(for home healthcare and professional 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, ±4kV, ±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 %.
Electrical fast transient/burst IEC 61000-4-4| ±2 kV for power supply lines
±1 kV for input/output lines| Not applicable
Not applicable| Mains power quality should be that of a typical home and professional healthcare environment.
Surge IEC 61000-4-5| ±0.5 kV, ±1 kV line(s) to line(s)
±0.5 kV, ±1 kV, ±2 kV line(s) to earth| Not applicable
Not applicable| Mains power quality should be that of a typical home and professional healthcare environment.
Voltage Dips, short interruptions and voltage variations on power supply input lines
IEC 61000-4-11| Voltage dips:
0 % UT; 0,5 cycle
0 % UT; 1 cycle
70 % UT; 25/30 cycles
Voltage interruptions: 0 % UT; 250/300 cycle| Voltage dips: Not applicable Not applicable Not applicable
Voltage interruptions:
Not applicable| Mains power quality should be that of a typical home healthcare and professional healthcare environment. If the user of FORA IR20/1R21 requires continued operation during power mains interruptions, it is recommended that FORA IR20/1R21 be powered from an uninterruptible power supply or a battery.
Power frequency (50, 60 Hz) magnetic field
IEC 61000-4-8| 30 Alm
50 Hz or 60 Hz| 30 A/m
50 Hz and 60 Hz| FORA IR20/1R21 power frequency magnetic fields should be at levels characteristic of a typical location in a typical home healthcare and professional healthcare environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
Manufacturer’s declaration-electromagnetic immunity

FORA IR20/1R21 is intended for use in the electromagnetic environment (for home healthcare and professional healthcare) specified below. The customer or the user of FORA IR20/1R21 should assure that it is used in the environment specified below.

Immunity test

| IEC 60601 test level| Compliance level|

Electromagnetic environment guidance
(for home healthcare and professional healthcare environment)

Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3| 3 Vrms:
0,15 MHz — 80 MHz
6 Vrms:
in ISM and amateur radio bands between 0,15 MHz and 80 MHz
80 % AM at 1 kHz
10 V/m
80 MHz — 2,7 GHz 80 % AM at 1 kHz| Not applicable
Not applicable
10 V/m
80 MHz — 2,7 GHz 80 % AM at 1 kHz| Portable and mobile RF communications equipment must not be used close to any parts of FORA IR20/1R21 including cables, other than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance:
d = 1,2 NIP
d = 1,2 NIP 80MHz to 800 MHz
d = 2,3 NIP 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:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply to 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 FORA IR20/1R21 is used exceeds the applicable RF compliance level above, FORA IR20/IR21 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating FORA IR20/1R21.
b)    Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Manufacturer’s declaration-electromagnetic Immunity
Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment

FORA IR20/1R21 is intended for use in the electromagnetic environment (for home healthcare and professional healthcare specified below. The customer or the user of FORA IR20/1R21 should assure that it is used in such an environment.
Test
frequency
(MHz)| Band”
(MHz)| Service”| Modulation b)| Maximum
power
(W)| Distance

(m)

| IMMUNITY
TEST LEVEL
(V/m)| Compliance LEVEL
(V/m)
(for home and professional healthcare)
385| 380 – 390| TETRA 400| Pulse modulation c)
18 Hz| 1.8| 0,3| 27| 27
450| 430 – 47| 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 modulationb)
18 Hz| 2| 0,3| 28| 28
870
930
1 720| 1 700 – 1 990| GSM 1800: COMA 1900: GSM 1900; DECT:
LTE Band 1, 3. 4. 25: UMTS| Pulse modulationb) 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:
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.

ForaCare Suisse AG
Neugasse 55, CH9000, St. Gallen, Switzerland
www.foracare.ch

MedNet EC-REP GmbH
Borkstraβe 10, 48163 Mϋnster, Germany

FORA IR21 Ear- Forehead Thermometer-- covelMby pSteghpdd
4

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