FORA IR20 Series Ear Thermometer Owner’s Manual

FORA IR20 Series Ear 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.

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.
• Temperature of left and right ear may differ. Always measure using the same ear.
• For proper hygiene, do not share probe cover. Damaged probe cover may result in error display.
• If you experience any serious incident related to this product’s use, 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 with a 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 IR20 ear thermometer. This innovative medical device relies 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 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 at home.

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

Thermometer Parts

1. Probe
2. Probe cover ejection button3
3. On/Memory button
4. Sticker
5. Battery cover
6. Data port
7. Probe lens
8. Probe cover
9. Scan button
10. Probe cover detector
11. Storage Tray

LCD Screen

1. Ear temperature indicator
2. Temperature scanning in progress
3. Temperature display
4. Memory mode
5. Record numbers
6. Low bettery indicator
7. Temperature unit
8. Communication symbol
9. Non-probe cover warning

Installing/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.

Step 2
Install the new battery in the battery compartment and press it in until the battery is firmly secured.

Step 3
Reattach the battery cover.

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 the next. It also varies by location on the body and different times 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 a fever.
Table 1 Body Site Normal Temperature Range

Axillary

(underarm)

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

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

Using the Device

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.

Installing/Replacing the Probe Cover

Step 1
Check if the probe cover is clean and new. Press the infrared probe into the cartridge.

Step 2
Secure the cover to the probe and remove it from cartridge.

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 replaced with a new and clean one after each measurement to ensure accuracy reading.
• For hygiene use, attach a new probe cover each time and do not touch its tip.

Taking Ear Temperature

Step 1
Make sure probe cover is firmly attached to the probe.

Step 2
Press and release the On/Memory button to turn on the thermometer. When ready, the thermometer displays the last measurement.

Step 3
Stretch your ear canal by pulling your ear backwards and upwards and carefully insert the thermometer into the ear.

Step 4
Press and release the Scan button. Do not remove the thermometer until it beeps.

Step 5
Read the result.  is shown together with a temperature value.

Step 6
Discard used probe cover in a trash can by pressing probe cover ejection button.

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

Recalling the Memory
Your thermometer stores 10 recent readings in the memory.

Step 1
Be sure the thermometer is OFF before recalling this memory.

Step 2
Press the On/Memory button to turn on the thermometer.

Step 3
Press the On/Memory button for 3 seconds to enter memory mode.
Each 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 the latest results with flashing . Then press On/Memorybutton 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 notest results in memory.

Viewing Results on a  Personal Computer and device
Results in memory can be transmitted to the personal computer by either cable or wireless connection for FORA IR20b/IR20c 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 IR2 0c.

Please contact your local customer service for above accessories.

Transmitting data via Cable (FORA IR20c)

Step 1 Install Software
Install Health Care System Software on your computer by following the instructions provided 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 turned 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 (FORA IR20b)

Step 1
Download the application ” iFORA MP ” to your device with an iOS or Android system.

Step 2
Turn on the meter, press and hold the On/Memory and Scan buttons simultaneously for 3 seconds until “CLr” appears on the display. Your meter is now in pairing mode, the Bluetooth indicator flashes in blue.

Flash slowly The meter is pairing with the

device of Bluetooth.

Lit solid

| The meter is transmitting the data now the connection is completed.

Step 3
Turn on the App, and start to pair your device.

NOTE
While the thermometer is connected to the PC or the App, it is unable to perform a test.

Step 4
Make sure your IR20b is already paired with your device (IR20b’s Bluetooth indicator lit solid).

Step 5
After successfully pairing the meter with your mobile device, the Bluetooth function of the meter will be activated automatically after each measurement. The meter is ready for transmitting the data to your app.

Care & Cleaning

• Keep the probe clean, as earwax and grease build up may affect the measurement.
• 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 red backlight. Please follow “what to do” to resolve problems. If the problem still exists, please call your local dealer for help.

Specifications

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 -20°C to 60°C (-4°F to 140°F) range
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

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.

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

FORA IR20 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 can help prevent electromagnetic interference by maintaining a minimum distance between the portable and mobile RF communications equipment (transmitters) and FORA IR20 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√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) 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 is intended for use in the electromagnetic environment (for home healthcare and professional healthcare) specified below.

The customer or the user of FORA IR20 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 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

|

Class B

|

FORA IR20 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|

Not applicable

Voltage fluctuations/flicker emissions

IEC 61000-3-3

|

Not applicable

Manufacturer’s declaration-electromagnetic immunity

FORA IR20 is intended for use in the electromagnetic environment (for home healthcare and professional healthcare) specified below. The customer or the user of FORA IR20 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 % U T; 0,5 cycle

0 % U T; 1 cycle

70 % U T; 25/30 cycles

Voltage interruptions: 0 % U T; 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 requires continued operation during power mains interruptions, it is recommended that FORA IR20 be powered from an uninterruptible power supply or

a battery.

Power frequency (50, 60 Hz) magnetic field

IEC 61000-4-8

| 30 A/m

50 Hz or 60 Hz

| 30 A/m

50 Hz and 60 Hz

| FORA IR20 power frequency magnetic fields should be at levels characteristic of a typical location in a typical home healthcare and professional healthcare environment.
NOTE U T is the a.c. mains voltage prior to application of the test level.
Manufacturer’s declaration-electromagnetic immunity

FORA IR20 is intended for use in the electromagnetic environment (for home healthcare and professional healthcare) specified below. The customer or the user of FORA IR20 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| 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

| Not applicable Not applicable| Portable and mobile RF communications equipment must not be used close to any parts of FORA IR20 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 √P

d = 1,2 √P 80MHz to 800 MHz d = 2,3 √P 800MHz to 2,7 GHz

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

| 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 is used exceeds the applicable RF compliance level above, FORA IR20 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.

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 is intended for use in the electromagnetic environment (for home healthcare and professional healthcare) specified below.

The customer or the user of FORA IR20 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 and pro- fessional healthcare)

385| 380 – 390| TETRA 400| Pulse modulation b)

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 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 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

References

• ForaCare Suisse AG - Comprehensive Disease Management Solutions

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