ForaCare IR42 User manual

IR42
Infrared Forehead
Thermometer
Operation Instructions
9. Do not use in presence of flammable anesthetic mixtures.
10. Do not use accessories which are not supplied or recommended by the
manufacturer. Do not try to modify the device to prevent any dangers.
11. Proper maintenance is essential to the longevity of your device. If you are
concerned about the accuracy of measurement, please contact the local
customer service or place of purchase for help.
12. Always contact the manufacturer or the manufacturer’s representative to
report unexpected operation or event. Do not try to fix it by yourself.
13. When using the thermometer, stay away from electromagnetic radiation,
such as the mobile in use.
14. Do not expose the device to strong electrostatic fields or strong magnetic
fields to avoid affecting the measurement accuracy.
15. Used in close proximity to others, EMC must be tested and verified.
16. Keep probe covers out of reach of children. The small parts detached from
the device may result children choking from inhaling or swallowing.
17. Do not try to maintain the device while it is in use.
18. This thermometer has been calibrated at the factory. If you follow the
instructions, you don't need to adjust it regularly. But if you are in doubt
about the accuracy of the readings, please contact the customer service.
CAUTIONS AND WARNINGS
• Always operate the thermometer in an operating temperature range 10°C to
40°C (50°F to 104°F), and relative humidity below 85%.
• Always store the thermometer in a cool and dry place: temperatures between
-20°C to 60°C (-4°F to 140°F); relative humidity below 85%. Avoid direct
sunlight.
• Avoid dropping the thermometer.
• This thermometer is not intended to be a substitution for a consultation with
your physician.
LCD SCREEN
311-1242100-010
Version 1.0 2020/02
INTRODUCTION
Thank you for choosing IR42 Forehead Thermometer. Please read this
instruction manual first so you can use this thermometer safely and correctly.
Please keep this instruction manual for future reference. This innovative
medical device uses advanced infrared (IR) technology to measure
temperature instantly and accurately on the forehead / surface. The IR42
Forehead Thermometer delivers a body temperature reading from the thermal
radiation emitted from the forehead without contact to the body. (The surface
temperature measurement is not for medical purposes.)
Before using this product, please read the following contents thoroughly and
carefully.
INTENDED USE
The IR42 forehead thermometer is intended for the intermittent measurement
and monitoring of human body temperature from the forehead. The device is
intended for use of all ages for home and professional use by one with a good
understanding of the operation instruction, where the patient may be an
operator.
HOW DOES IT WORK
The thermometer measures the infrared heat generated by the surface of the
skin over the vessel and its surrounding tissue.
The thermometer then converts it into a temperature value shown on LCD.
IMPORTANT SAFETY INSTRUCTIONS
READ THIS BEFORE USING AND KEEP THESE INSTRUCTIONS
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
sustained any damage.
4. Keep the sensor end clean and free of debris. See Maintenance section for
instructions.
5. Do not use ethylene oxide gas, heat, autoclave, or any other harsh
methods to sterilize the device.
6. Put in place the protective sensor cap on the sensor end when not in use.
7. If coming from an environment of warmer or cooler temperature or after a
period of exertion, allow the user and the thermometer to acclimate to room
temperature for 20 minutes prior to taking a measurement.
8. As the forehead temperature may be affected by sweat, oil and the
surrounding temperature, the reading shall be taken as a reference only.
APPEARANCE AND KEY FUNCTIONS
HOW TO USE
INSTALL BATTERY
1. Remove battery cover by pressing down at the arrow mark and slide in the
direction of the arrow (Figure 1).
2. Install (2) AAA alkaline batteries and close the battery cover (Figure 2).
3. If thermometer will be stored without use, remove batteries.
Warning:
Make sure the battery cover is properly closed and secured.
MEASURING TEMPERATURES-ADULTS
(older than 36 months)
1. Remove protective cap. The forehead should be clear of hair and
perspiration.
2. Aim at the center forehead area 3 to 7cm (1” to 2.5”) away from skin
surface. Be sure the thermometer is perpendicular to the skin surface.
1Temperature display
Error message
Memory mode
Hold Symbol
Temperature unit
Battery indicator
Adult body temperature indicator
Child body temperature indicator
Object surface temperature indicator
2
3
4
5
6
7
8
9
6789
3 4
2
1
5
( Figure 1 ) ( Figure 2 )
3. Press and release the SCAN button to take a measurement. A double
“beep” sound indicates a reading has been taken and displayed on the
LCD screen.
When a reading is greater than 38.0°C, a warning symbol will flash.
4. To take another measurement, follow step 2 and 3.
5. The thermometer turns off automatically after 30 seconds. Replace the
sensory cap when finished.
NOTE:
• If the reading is ≤ 31.9°C (89.5°F), the display will show “Lo”.
• If the reading is ≥ 43.1°C (109.5°F), the display will show “Hi”.
MEASURING TEMPERATURES-CHILDREN
(younger than 36 months)
1. Press the SCAN button to turn on the thermometer.
2. Press and hold the MODE button for 1 second before releasing. An adult
facial profile should be flashing, indicating that the preset mode is for
adults.
3. Press the MODE key to switch to Child mode, indicated by a smiley face
icon.
5. The thermometer automatically switches off when left idle for 30 seconds.
6. Replace the sensor cap when finished.
NOTE:
• If the reading is ≤ 31.9°C (89.5°F), the display will show “Lo”.
• If the reading is ≥ 43.1°C (109.5°F), the display will show “Hi”.
MEASURING TEMPERATURES-SURFACE
1. Press the SCAN button to turn on the thermometer.
2. Press and hold the MODE button for 1 second before releasing. An adult
facial profile should be flashing, indicating that the preset mode is for
adults.
3. Press the MODE key to switch to Surface mode, indicated by a
thermometer icon.
4. Aim the scanner at the center of the child’s forehead 3 to 7cm (1” to 2.5”)
away from skin surface. Press and release the SCAN button to take a
measurement. A warning symbol indicates a reading greater than 37.6 °C
(99.7°F).
4. Press the SCAN button. Make sure the probe is flat and close to the object
surface, not at an angle. Perform an object measurement with a distance
within 5 cm (1.9 inch). Press and hold the SCAN button as you move the
meter along the surface. The HOLD symbol will be flashing.
CHANGING UNIT OF MEASUREMENT
1. With the thermometer off, press and hold the MODE button for 1 second.
The current unit of measurement will be flashing. The default setting is in
°C.
2. Press the MODE button again to make a switch in the unit of
measurement.
3. When finished, press the SCAN button to turn off the thermometer. The
thermometer switches off automatically when left idle for 30 seconds.
HINTS ON TAKING TEMPERATURES
1. As with other thermometers, 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.
2. Do not take a reading while the person is moving and / or talking. Wait 30
minutes after any of the following situations before taking a measurement:
■ When the forehead has been covered.
■ After the person has been exercising, swimming, or taking a bath.
■ When the person has been exposed to extreme temperature.
RECALLING PAST READINGS
The IR42 stores 30 most recent readings.
1. Press and release the SCAN button to turn on the thermometer.
2. Press and hold the MEMORY button for 1 second to enter the memory
mode indicated by a flashing " " symbol. The most recent reading stored
will be displayed.
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 (armpit) 0.3°C to 0.6°C (0.5°F to 1°F) lower than oral temperature
3. Press and release the MEMORY button to cycle through older readings.
4. When left idle for 30 seconds, the thermometer automatically switches off.
NOTE:
When the memory is full, the oldest result is deleted as the new ones are
added. While recalling previous readings, you may take a measurement by
pressing the SCAN button.
NORMAL BODY TEMPERATURE & FEVER
Body temperature can vary from one individual/person to next. It also varies by
location on the body and time of day. Fever indicates that the body
temperature is higher than normal. This symptom may be 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.
Source: Body Temperature at WebMD; website:
http://firstaid.webmd.com/body-temperature retrieved at 2010 Jan 7.
Please consult your physician if you are concerned about your body
temperature readings.
MAINTENANCE
• The IR42 has no user serviceable internal parts except battery replacement.
• Always replace Sensor Cap (or place in cradle) when not in use.
• Store in a dry location free of dust and away from direct sunlight.
• Use a soft dry cloth to clean the plastic housing or a cloth dampened with a
solution of water and mild detergent. Occasionally, 70% isopropanol solution
may be used. Never submerge in liquid.
• The sensor window is recessed to assist in keeping it clean and free of
debris. Inspect the lens and remove any debris. Smudges may be cleaned by
gently wiping the window with a small foam-tipped swab (non-lining)
moistened with 70% alcohol. Wait 10 minutes prior to taking temperatures.
TaiDoc Technology Corporation
B1-7F, No. 127, Wugong 2nd Rd., Wugu Dist.,
24888 New Taipei City, Taiwan
www.taidoc.com
Distributed by
ForaCare Global Corp.
1F, No. 127, Wugong 2nd Rd., Wugu District,
New Taipei City 24888, Taiwan
Tel: [phone]
Fax: [phone]
www.foracare.com
0123
5. Release the button and read the result.
NOTE:
• If the reading is ≤ 0.0°C, the display will show “Lo”.
• If the reading is ≥ 100.1°C, the display will show “Hi”.
1Display Screen
Power / Scan Button
Probe Cover
Probe
Mode / Set Button
Memory Button
Battery Cover
2
3
4
5
6
7
MEMORY SET MORE
1
2
5
6
7
3
4

TROUBLESHOOTING SPECIFICATIONS
Model No.: IR42
Dimension & Weight: 155.46 (L) x 40.14 (W) x 39.45 (H) mm, 61.8g (without
battery)
Power Source: 2 x 1.5V AAA alkaline batteries
Battery Life: With new batteries, approx. 3,000 measurements.
Displayed Temperature range
• Forehead: 32°C to 43°C (89.6°F to 109.4°F)
• Surface: 0°C to 100°C (32°F to 212°F)
Display Resolution: 0.1°C / 0.1°F
Accuracy: Meet the accuracy requirement specified in ASTM E1965-98 and
ISO 80601-2-56
• Forehead:
±0.2°C (±0.4°F) for the range of 35.0°C to 42.0°C (95°F to 107.6°F) / ±0.3°C
(±0.5°F) for the range of <35.0°C (95°F) or >42.0°C(107.6°F)
• Surface: ±1°C (±2°F)
Temperature Unit: °C (Default) or °F
Operating Temperature range: 10°C to 40°C (50°F to 104°F)
Operating Humidity: below 85% relative humidity
(non-condensing)
Operating Atmosphere Pressure: 700hPa to 1060hPa
Storage / Transportation Temperature range: -20°C to 60°C (-4°F to 140°F)
Storage / Transportation Humidity: below 85% relative humidity
(non-condensing)
Memory Capacity: 30 measurements
Ingress Protection Rating: IP22
Expected Service Life: 3 years
The specifications may be changed without prior notice.
REFERENCE STANDARDS
Device Standard:
Device Corresponds to the requirements of the standard for infrared
thermometers ASTM E1965-98, EN ISO 80601-2-56:2017, EN
60601-1-2:2015, EN 60601-1:2006+A12:2014, EN 60601-1-6:2010
Electromagnetic Compatibility:
Device fulfills the stipulations of the standard EN 60601-1-2.
The stipulations of EU-Directive 93/42/EEC for Medical Devices Class Ila have
been fulfilled.
SYMBOL INFORMATION
Symbol Referent
Consult instructions for use
This device does not belong to household waste and must be
returned to a collection point for recycling electric and electronic
devices according to local laws. If it contains batteries, the
batteries should be removed and disposed in accordance with local
regulations for separate collection of spent batteries.
Manufacturer
Serial number
Caution
CE mark
Symbol Referent
Type BF applied part
Temperature limit
Humidity limitation
Resistant to liquid ingress
RoHS Compliance
MESSAGE WHAT IT MEANS WHAT TO DO
Appear when ambient
temperature is outside of
the operating temperature
range.
Only operate the thermometer
in ambient temperature range of
10°C to 40°C (50°F to 104°F).
Surface temperature
measured outside of the
measurement range (0.0 to
100.0 °C).
Review the instructions and
re-start the measurement
procedure.
Low or no power. Replace with new batteries.
Measured temperature
below the measurement
range (below 32.0 °C).
Review instructions and repeat
measurement. Make sure the
distance from forehead is not
greater than 7cm (2”), and that
the forehead is clear.
Measured temperature
above the measurement
range (above 43.0 °C).
Review instructions and repeat
measurement. Consult with a
physician if the problem
persists.
IP22
0123
Electromagnetic environment-guidance
(for home and professional healthcare environment)
Emission test
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions IEC 61000-3-2
Voltage fluctuations / flicker emissions IEC 61000-3-3
Group 1
Class B
Not applicable
Not applicable
Compliance
Manufacturer’s declaration-electromagnetic emissions
The IR42 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below.
The customer or the user of the IR42 should assure that it is used in such an environment.
The IR42 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.
The IR42 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.
Electromagnetic environment-guidance
(for home and professional healthcare environment)
Electrostatic
discharge(ESD) IEC
61000-4-2
Compliance levelIEC 60601 test levelImmunity test
Manufacturer’s declaration-electromagnetic immunity
The IR42 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below.
The customer or the user of the IR42 should assure that it is used in such an environment.
Floors should be wood, concrete or ceramic tile. If floors are
covered with synthetic material, the relative humidity should
be at least 30%
Mains power quality should be that of a typical home and
professional healthcare environment.
Mains power quality should be that of a typical home and
professional healthcare environment.
The IR42 power frequency magnetic fields should be at
levels characteristic of a typical location in a typical home
healthcare environment.
Mains power quality should be that of a typical home and
professional healthcare environment. If the user of the IR42
requires continued operation during power mains
interruptions, it is recommended that the IR42 be powered
from an uninterruptible power supply or a battery.
Electrical fast
transient/burst IEC
61000-4-4
Surge IEC
61000-4-5
Power frequency(50,
60 Hz) magnetic field
IEC 61000-4-8
Voltage Dips, short
interruptions and
voltage variations on
power supply input
lines IEC 61000-4-11
Contact:±8 kV
Air±2 kV,±4 kV,
±8 kV,±15 kV
Not applicable
Not applicable
Not applicable
Not applicable
30 A/m
50 Hz and 60 Hz
Voltage dips:
Not applicable
Not applicable
Not applicable
Voltage interruptions:
Not applicable
Contact:±8 kV
Air±2 kV,±4 kV,
±8 kV,±15 kV
+ 2kV for power supply lines
+ 1kV for input/output lines
+ 0.5kV, +1kV line(s) to line(s)
+ 0.5kV, +1kV,+ 2kV line(s) to
earth
30 A/m
50 Hz or 60 Hz
Voltage dips:
0 % UT; 0,5 cycle
0 % UT; 1 cycle
70 % UT; 25/30 cycles
Voltage interruptions:
0 % UT; 250/300 cycle
NOTE UT is the a.c. mains voltage prior to application of the test level.
Separation distance according to frequency of transmitter
m
0,01
0,1
1
10
100
N/A
N/A
N/A
N/A
N/A
0,12
0,38
1,2
3,8
12
0,23
0,73
2,3
7,3
23
Rated maximum output power
of transmitter
W150 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
Recommended separation distance between
portable and mobile RF communications equipment and the IR42
The IR42 is intended for use in an electromagnetic environment (for home and professional healthcare) in which radiated RF disturbances
are controlled. The customer or the user of the IR42 can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the IR42 as recommended below, according to the
maximum output power of the communications equipment.
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be
estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer.
NOTE1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
385 380 –390 TETRA 400
Pulse
modulation b)
18 Hz
1,8 0,3 27 27
710
745
780
704 – 787 LTE Band 13,
17
Pulse
modulation b)
217 Hz
0,2 0,3 9 9
5 240
5 500
5 785
5 100 –
5 800
WLAN 802.11
a/n
Pulse
modulation b)
217 Hz
0,2 0,3 9 9
810
870
930
800 – 960
GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulation b)
18 Hz
2 0,3 28 28
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
1 720
1 845
1 970
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
450 430 – 470 GMRS 460,
FRS 460
FM c)
±5 kHz deviation
1 kHz sine
2 0,3 28 28
Test
frequency
(MHz)
Maximum
power
(W)
Distance
(m)
IMMUNITY
TEST LEVEL
(V/m)
Compliance LEVEL
(V/m) (for home and
professional healthcare)
Band a)
(MHz)
Service a) Modulation b)
Manufacturer’s declaration-electromagnetic immunity
Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment
The IR42 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below.
The customer or the user of the IR42 should assure that it is used in such an environment.
NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or
ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50 % duty cycle square wave signal.
c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual
modulation, it would be worst case.
Electromagnetic environment-guidance
(for home and professional healthcare environment)
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
Compliance levelIEC 60601 test levelImmunity test
Manufacturer’s declaration-electromagnetic immunity
The IR42 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below.
The customer or the user of the IR42 should assure that it is used in such and environment.
Portable and mobile RF communications
equipment should be used no closer to any part of the IR42
including cables, 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
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).
Interference may occur in the vicinity of equipment marked
with the following symbol:
Not applicable
Not applicable
10 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
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
NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.