AVITA NTW-17XX Touch Free Infrared Thermometer User Manual

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Date Submitted	2017-04-12 00:00:00
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Creation Date	2017-04-10 14:21:18
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Document Author:	harriet_g

Contents
Introduction ...................................................... 1
Important Information Before Use ................... 2
Product Identification ....................................... 3
Model: NT16B
Description of LCD Display.............................. 4
Battery Installation ........................................... 5
Switching Between Fahrenheit or Celsius ....... 6
Switching between 4 Kinds of Scan Mode ...... 6
Tips for Measuring Human Temperature......... 7
Measuring Human Temperature...................... 7
Measuring Object/Liquid Temperature ............ 9
Memory Function ........................................... 10
Cleaning and Disinfecting .............................. 11
Applied Standards ......................................... 12
FCC Important Information ............................ 12
Error Codes.................................................... 13
Operating the Bluetooth function ................... 14
Technical Specification .................................. 15
EMC Tables ................................................... 16
Explanation of Symbols ................................. 20
INSTRUCTION MANUAL
Please read this instruction manual carefully
before using your ear thermometer
Introduction
Important Information Before Use
Utilizing infrared technology, this thermometer takes
temperatures in seconds by measuring heat generated by
measuring heat generated by the surface skin of the forehead
or other objects. This product conforms to the provisions of the
EC directive MDD(93/42/EEC).Its advantages include:
1. 6 in 1 functions
Human Body/Object/Night Mode Option/Fever Alarm/ 30
User Memory/Backlight
2. Night Mode Option
Switch to Night mode to reduce the interference of buzzer
during your baby sleeping.
3. Red LED Light for Fever Alarm
This device has the LED light to remind user their readings
are over 38°C and plus the beep sound only in Human
Body Mode.
4. 30 User Memory
5. Illuminated Backlight Display
6. °C/°F Switch-able Function
7. One-second Reading
8. Auto power off for power saving
9. Low-battery Indicator
Indications for battery condition and measuring range.
10.Large LCD Display
11.Economic design and convenience:
This is a “Non-contact” medical thermometer that
enables temperature readings, designed for sanitary
conditions, cleanliness, and convenience. Simply move
the thermometer close to the subject's forehead or object
at the distance indicated by the device.
12.Instant Measurement
By using our unique technology, users can get their precise
body temperature instantly and accurate.
When using this product, please be sure to follow all the notes
listed below. Any action against these notices may cause
injury or affect the accuracy.
1. Do not disassemble, repair, or remodel the thermometer.
2. Be sure to clean the thermometer lens each time after
usage.
3. Avoid direct finger contact with the lens.
4. No modification of this equipment is allowed.
5. It is recommended that user may take 3 temperatures. If
they are different, use the highest reading.
6. Do not expose the thermometer to extreme temperature,
very high humidity, or direct sunlight.
7. Avoid extreme shock or dropping the device.
8. Before the measurement, patients and thermometer should
stay in steady state room condition for at least 30 minutes.
9. Avoid measuring temperature in 30 minutes after exercise,
bathing, or returning from outdoor.
10. To protect the environment, dispose of empty batteries at
appropriate collection sites according to national or local
regulations.
11. It is ill-advised to disassemble the thermometer.
12. Please use the thermometer solely for its intended purpose.
13. Carefully hold the device when in use to avoid dropping the
device.
14. Allow one minute between successive measurements as
slight variations may occur if measurements are taken over
a short period of time. Use average temperatures instead.
15. There are no absolute body temperature standards. Keep
reliable records of your personal temperature to serve as a
reference for judging a fever.
16. Under any circumstances, the temperature taking result is
ONLY for reference. Before taking any medical action,
please consult your physician.
17. It is recommended calibrate the device every 1 year.
18. This device complies with Part 15 of the FCC Rules.
Operation is subject to the following two conditions: (1) this
device may not cause harmful interference, and (2) this
device must accept any interference received, including
interference that may cause undesired operation.
Product Identification
Description of LCD Display
Battery Installation
Low battery warning:
When the battery power becomes low, the
low battery symbol will appear on the display.
The thermometer can still be used during this
time, but the batteries should be replaced as
soon as possible. If the batteries run out
completely, “Lo” will be displayed along with
the low battery symbol. In this case, the batteries will need to
be replaced before using the thermometer again.
Replacing the Battery:
1. Gently slide the battery cover back.
2. Carefully remove the old batteries and properly discard.
3. Insert new batteries (Two 1.5V alkaline AAA Size)
according to the proper polarity.
4. Slide the battery cover back on.
Switching Between Fahrenheit or Celsius
Your thermometer can display results in
either degrees Celsius (°C) or degrees
Fahrenheit (°F).
To switch between Celsius and Fahrenheit,
while the unit is on press and hold both the
Human/Object button and the Memory button
for approximately 3 seconds. This will change
the mode to either °C or °F. Once the
thermometer beeps, at which time the mode
has been changed and you may release the
buttons.
Switching between 4 Kinds of Scan Mode
1. Under power on status, you can press the Human/Object
button to switch different scan mode. There are 4 kinds of
mode which including Human, Object, Human/Night, and
Object/Night mode (in order).
2. The beep sounds will be closed when your choice in
Human/Night mode, and Object/Night mode, and the Moon
symbol will appears on the LCD in both Night mode.
NOTE: Battery-operated
1. Please properly dispose of the batteries away from small
children and heat.
2. It is recommended to remove the batteries if the unit will not
be used for an extended period of time.
3. For long durations of non-operation, please remove all
batteries from the device.
4. Batteries must be disposed of in accordance with local
environmental and institutional policies.
5. Dispose of used batteries in accordance with the applicable
legal regulations. Never dispose of batteries in the normal
household waste.
NOTE:
Each press will comes with a beep sound to ensure the setting
is activated. (Except both Night modes)
Tips for Measuring Human Temperature
Bear in mind that the thermometer needs to have been in the
room in which the measurement is taken for at least 30
minutes before use.
NOTE:
• Attempting to take temperature readings from sites on the
body other than the forehead may produce inaccurate
results.
• The patient should remain still while the reading is being
taken.
• Infrared forehead temperature readings are equivalent to
oral temperature readings. In all of these cases, please
consult your doctor.
• Readings taken while asleep should not be compared
directly to readings taken while awake, as body
temperature while asleep is typically lower.
• Do not take body temperature readings within 30 minutes
of being outdoors, exercising or bathing.
Measuring Human Temperature
Taking a Measurement
1. Press the Measure button to power on the thermometer.
The unit will run a self-test and the LCD will briefly display
all of its symbols during this time. When the device is ready,
‘00’ will appear on the screen, and the thermometer will
beep twice.
2. Select the desired mode by pressing and releasing the
Human/Object button.
Note:
- When taking a patient’s temperature, ensure that the
thermometer is in Human mode; the Human symbol
“ ”will appear on the display.
- If the patient’s skin is covered with hair, sweat, or dirt, clean
the area and wait 10 minutes before taking a measurement.
- Ensure that the thermometer is held firmly during
measurement and that the patient does not move until the
measurement is complete. Movement can impact the
measurement.
Measuring Human Temperature
3. Position the thermometer under 3cm (around 1 inches)
from the center of the patient's forehead with the sensor
aimed between the eyebrows.
4. Press and release the Measure button.
5. Slowly move the device toward or farther from the
forehead until you have reached the correct distance. (If
the distance is beyond the correct distance, the dash-icon
on the display flashes with beep sound in this sequence
until the correct distance is achieved. )
Note:
When the user presses the measure button,
this workflow begins and they have 20
seconds to capture the temperature. After 20
seconds, the display turn to stand-by mode.
6. As you hear a short beep means this
temperature reading has been completed
and accompany with a back-light.
7. If the temperature measurement is below
38°C, a “Smiling Face ” will be appear
next to the reading. If the reading is 38°C
or above, a “Frowning Face ” will be
displayed and the RED LED light up.
8. After about 30 seconds after use, the
thermometer will automatically beep and
shut off.
Fever Alarm:
Only in Human Mode and Human/Night Mode
Measuring Object/Liquid Temperature
1. Press the Power button to turn the
thermometer on. All symbols on the display
will momentarily appear.
2. Ensure that the thermometer is in Object
mode; the Object symbol will be on the
display. To alternate between modes press
and release the Human/Object Mode button
until you see the desired measurement
symbol on the display.
3. Position the thermometer under 3cm (around 1 inches)
from the object.
4. Press and release the “Power & Measure button” and the
temperature reading will be displayed.
5. After about 30 seconds after use, the thermometer will
automatically beep and shut off.
Memory Function
Memory Recall:
You can recall up to 30 measurements currently stored in
memory to share with your physician or
trained healthcare professional.
1. When the device is on, press once briefly
on the "MEM button", then pass it again
to show the last measurement
” symbol.
accompanied by “
”
“
” symbol will appear with each
“
symbol or
2. The
measurement stored in memory to indicate whether a
person or object temperature was taken.
3. Each press of the same button recalls a previous
” then all the way to “
”.
measurement, so “
Memory Deletion:
1. Under power on status, you may keep press MEM Button
for more than 3 seconds to delete all the readings.
2. You will see "00" on display and “sound a beep”, that
mean all the memories are cleared.
3. Automatically on the 31th measurement:
when the 30 memories have been used up, any new
” and the oldest
measurement will be recorded with “
memory deleted without you having to do anything.
Note:
All the readings will be cleared no matter record in Human
mode or Object mode.
10
Clinical accuracy validation method
NT16B is an adjusted mode clinical thermometer
the validated information for clinical accuracy in each
adjusted mode are:
GroupA1:
GroupA2:
GroupB :
GroupC :
∆cb=-0.01°C, LA=0.18, σr=±0.08°C
∆cb= 0.06°C, LA=0.22, σr=±0.08°C
∆cb=-0.01°C, LA=0.20, σr=±0.07°C
∆cb=-0.01°C, LA=0.18, σr=±0.07°C
cb: CLINICAL BIAS
LA: LlMITS OF AGREEMENT
σr: CLINICAL REPEATABILITY
Cleaning and Disinfecting
Applied Standards
This product conforms to the provisions of the EC directive
MDD(93/ 42/ EEC). The following standards apply to design
and/or manufacture of the products:
‧ ISO 80601-2-56
Medical electrical equipment -- Part 2-56: Particular
requirements for basic safety and essential performance
of clinical thermometers for body temperature
measurement
‧ IEC/EN 60601-1
Medical electrical equipment- Part 1: General requirement
for safety
‧ IEC/EN 60601-1-2
Medical electrical equipment- Part 2: Collateral standard:
Electromagnetic compatibility - Requirements and tests
FCC Important Information
For home use device disinfection, 70% Ethanol or Isopropyl
alcohol(available in the pharmacy) can be used.
- Clean the measuring sensor after each use. Use a clean
cloth or cotton bud that can be moistened with 70 % alcohol.
- To clean the entire device, please use a soft cloth slightly
moistened with a mild soapy solution. Under no
circumstances may liquid enter the device. Do not use the
device again until it is completely dry.
a.
FCC Caution: To assure continued compliance,
(example – use only shielded interface cables when
connecting to computer or peripheral devices). Any
changes or modifications not expressly approved by the
party responsible for compliance could void the user＇s
authority to operate this equipment.
b.
This device complies with Part 15 of the FCC
Rules. Operation is subject to the following two
conditions: (1) this device may not cause harmful
interference, and (2) this device must accept any
interference received, including interference that may
cause undesired operation.
c.
This device complies with FCC radiation
exposure limits set forth for an uncontrolled
environment. End users must follow the specific
operating instructions for satisfying RF exposure
compliance. This transmitter must not be colocated or
operating in conjunction with any other antenna or
transmitter.
11
12
Error Codes
Operating the Bluetooth function
When a malfunction or incorrect temperature measurement
occurs, an error message will appear as described below.
What You Need
NT16BB Bluetooth IR Ear Thermometer
An Android device with Android version 4.3 or above and
hardware support for Bluetooth 4.0.
An iOS device with iOS version 5 or above and hardware
support for Bluetooth 4.0. All devices Apple released since
the iPhone 4S (including the 4S) do, the older ones don’t.
LCD Display
Cause
Solution
The temperature measured
Operate the
is higher than
thermometer only
1. Human thermometer
mode:
between the
specified
43°C (109.4°F)
temperature
2. Object temperature
mode:
ranges. If
necessary, clean
100°C (212.0°F)
the sensor tip. In
The temperature
the event of a
measured is lower than
repeated error
1. Human thermometer
message, contact
mode:
your retailer or
34°C (93.2°F)
Customer
2. Object temperature
Services.
mode:
0°C (32°F)
Operate the
thermometer only
The operating temperature
between the
is not in the range
specified
15°C~35°C (59°F~95°F)
temperature
ranges.
13
Note:
Please refer to the instruction manual of your smart phone
for how to activate the Bluetooth function.
Set Up Process
1. Download an app which supports Bluetooth 4.0 from
the iTune App Store or Google Play.
2. Enable Bluetooth on your mobile device.
3. Open the app and activate the measure function.
4. Turn on the NT16BB.
5. The app should automatically detect your NT16BB. Tap
the NT16BB that is showed in the device list.
6. Your NT16BB is now successfully connected to your
mobile device. Every temperature reading will be
transfer to your mobile device automatically.
14
Operating the Bluetooth function
• Measuring range :
Human Body : 34°C~43°C (93.2°F~109.4°F)
Object : 0°C~100°C (32.0°F~212.0°F)
• Calibration Accuracy:
Human Body :
±0.2°C(±0.4°F): from 34 to 43 °C (93.2 to 109.4 °F)
Object : < 40°C ± 2°C; >= 40°C ± 5%
• Display resolution : 0.1°C
• Measuring site: Forehead
• Reference body site: Ear
• Operating environment :
15°C~35°C (59°F ~ 95°F)
with relative humidity up to 95% (non condensing)
• Storage/ Transportation environment :
-25 to 55 °C(-13 to 131 °F)
with relative humidity up to 95% (non condensing)
• Power supply : 2 x 1.5V AAA size alkaline batteries
• Weight : approx. 80g (with batteries)
• Dimensions :
approx. 52.4mmX44.5mmX129.9mm (L×W×H)
• Operation Distance : 3 cm
• For Customer Service
It is recommended that the accuracy should be checked by
manufacture every 1 years. To obtain the service please
contact AViTA Corp. for the address of the repair location.
Enclose the Proof of Purchase. Include $10.00 USD for the
return shipping and handling. Include a letter, with your
name, address, phone number, and description of the
specific problem. Pack the product carefully to prevent
damage in transit. Because of possible loss in transit, we
recommend insuring the product with return receipt
requested.
15
EMC Tables
Medical Electrical Equipment needs special precautions regarding
EMC and needs to be installed and put into service according to
the EMC information.
1. Electromagnetic/Radio Frequency Interference (EMC/RFI):
Readings may be affected if the unit is operated within a radio
frequency electromagnetic fi eld strength of approximately 3
volts per meter, but the performance of the instrument will not
be permanently affected. Care should be taken to keep the
NT16B at least 6 inches away from R/C transmitters to avoid
radio frequency interference.
2. Avoid keeping the NT16B too close to objects that continuously
generate high heat (like a hot plate) for long periods of time,
which can cause overheating of the NT16B.
Table 1 For all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacturer’s declaration-electromagnetic emissions
The NT16B TOUCH FREE Infrared Thermometer is intended for use in the
electromagnetic environment specified below. The customer or the user of
the NT16B TOUCH FREE Infrared Thermometer should assure that it is
used in such an environment.
Electromagnetic
Emissions test
Compliance
environment-guidance
RF emissions CISPR 11 Group 1
The NT16B TOUCH FREE
Infrared Thermometer uses RF
energy only for its internal
function.
Therefore, its RF emissions are
very low and are not
likely to cause any interference
in nearby electronic equipment.
The NT16B TOUCH FREE
RF emissions CISPR 11 Class B
Harmonic emissions
Not applicable Infrared Thermometer is
suitable for use in all
IEC 61000-3-2
Voltage fluctuations
Not applicable establishments other that
domestic and those directly
Flicker emissions
connected to the public
IEC 61000-3-3
low-voltage power supply
network that supplies buildings
used for domestic purposes.
16
EMC Tables
EMC Tables
Table 2 For all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacturer’s declaration-electromagnetic immunity
The NT16B TOUCH FREE Infrared Thermometer is intended for use in the
electromagnetic environment specified below. The customer or the user of
the NT16B TOUCH FREE Infrared Thermometer should assure that it is
used in such an environment.
Immunity
IEC 60601
Compliance
Electromagnetic
test
Test level
Level
environment-guidance
Electrostatic
±6kV contact
±6kV
Floor should be wood,
discharge (ESD) ±8kV air
contact
concrete or ceramic tile. If
IEC 61000-4-2
±8kV air
floors are covered with
shythetic material, the
relative humidity should
be at least 30%.
Electrical fast
±2 kV for power Not
Mains power quality
transient/burst supply lines
applicable should be that of a typical
IEC 61000-4-4 ±1 kV air for
commercial or hospital
input/output
environment.
lines
Surge
±1kV differential Not
Mains power quality
IEC 61000-4-5 mode
applicable should be that of a typical
±2kV common
commercial or hospital
mode
environment.
Mains power quality
Voltage dips,
<5% UT (>95% Not
short
dip in UT for 0.5 applicable should be that of a typical
commercial or hospital
interruptions and cycle
environment. If the use of
voltage
the TS41
variations on
40% UT (60%
Ear/Forehead/Object
power supply
dip in UT for 5
Thermometer requires
input lines
cycles
continued operation
IEC 61000-4-11
during power mains
70% UT (30%
interruptions, it is
dip in UT for 25
recommended that the
cycles
TS41
Ear/Forehead/Object
5% UT (>95%
Thermometer be powered
dip in UT for 5
from an uninterruptible
sec
power supply or a battery.
Power
3 A/m
3A/m
Power frequency
frequency
magnetic fields should be
(50/60 Hz)
at levels characteristic of
magnetic field
a typical location in a
IEC 61000-4-8
typical commercial or
hospital environment.
NOTE
is the a.c. mains voltage prior to application of the test level.
Table 3 For EQUIPMETN and SYSTEMS that are not
LIFE-SUPPORTING
Guidance and manufacturer’s declaration-electromagnetic immunity
The NT16B TOUCH FREE Infrared Thermometer is intended for use in the
electromagnetic environment specified below. The customer or the user of
the NT16B TOUCH FREE Infrared Thermometer should assure that it is
used in such an environment.
Immunity
IEC 60601 Compliance
Electromagnetic
test
Test level
Level
environment-guidance
Conducted RF 3Vrms
3 Vrms
Portable and mobile RF
IEC 61000-4-6 150kHz to 80
communications equipment
MHz
should be used no closer to
any part of the NT16B
Radiated RF 3V/m
3 V/m
TOUCH FREE Infrared
IEC 61000-4-3 80MHz to 2.5
Thermometer, including
GHz
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 80 MHz to 800 MHz
d=2.3√P 800 MHz to 2.5 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 meters (m).
Field strengths from fixed RF
transmitters, as determined by
an electromagnetic site
survey,” should be less than
the compliance level in each
frequency range.” Interference
may occur in the vicinity of
equipment marked with the
following symbol:
17
18
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 affected by absorption and reflection from structures, objects
and people.
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 NT16B TOUCH FREE
Infrared Thermometer is used exceeds the applicable RF compliance level
above, the NT16B TOUCH FREE Infrared Thermometer should be
observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the
NT16B TOUCH FREE Infrared Thermometer.
Over the frequency range 150kHz to 80MHz, field strengths should be less
than [V1] V/m.
EMC Tables
Table 4 For EQUIPMETN and SYSTEMS that are not
LIFE-SUPPORTING
Recommended separation distances between portable and mobile RF
communications equipment and the NT16B TOUCH FREE Infrared
Thermometer
The NT16B TOUCH FREE Infrared Thermometer is intended for use in an
electromagnetic environment in which radiated RF distances are controlled.
The customer or the user of the NT16B TOUCH FREE Infrared Thermometer
can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment
(transmitters) and the NT16B TOUCH FREE Infrared Thermometer as
recommended below according to the maximum output power of the
communications equipment.
Rated maximum
Separation distance according to frequency of
output power of
transmitter
transmitter
150kHz to 80MHz 80kHz to 800MHz
800kHz to
d=1.2√P
d=1.2√P
2.5GHz
d=2.3√P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
Explanation of Symbols
The CE marking with the Registration Number
of the Notified Body. This denotes the
compliance of European Medical Device
Directive 93/42/EEC
Follow instructions for use
Disposal information: Should you wish to
dispose of the article, do so in accordance with
current regulations. Details are available from
your local authority
Type of protection of applied part against
electric shock, body floating
This product meets the basic safety and
essential performance requirements indicated
in the IP22 conditioning test (protection
against solid foreign objects of 12.5mm ∅
and greater and against vertically falling water
drops when enclosure tiled up to 15°)
Temperature limits
European Authorized Representative
Manufacturer’s name and address
SN YYMWWWXXXXX
SN: Product Serial Number
YY: year, M:month, WWW: working sheet,
XXXXX: serial no.
19
20
72-N16BMN-AV1
2017-03-27

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