PROFESSIONAL MEDICAL PRODUCTS
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
A200 INFRARED
NON CONTACT
THERMOMETER
Please note:
This medical instrument must be used
according To instructions to ensure
accurate readings.
System Owner
Thank you for purchasing the A200 Infrared 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 or object.
IMPORTANT SAFETY INSTRUCTIONS
READ BEFORE USE
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.
KEEP THESE INSTRUCTIONS AT A SAFE
PLACE
CONTENTS
BEFORE YOU BEGIN ........................................ 2
Cautions and Warnings ..................................... 2
Restrictions of Use ............................................ 3
Intended Use ..................................................... 3
How does it work .............................................. 4
Highlighted Features ......................................... 4
Meter Overview ................................................. 4
Display Screen................................................... 5
Display Mode..................................................... 5
Select the Temperature Unit .............................. 5
Turn ON/OFF the Led Light ............................... 6
Replacing the Battery ........................................ 6
DETAILED INFORMATION ................................. 7
About Normal Body Temperature & Fever......... 7
PERFORM THE TEST ........................................ 8
As a Body Measurement Thermometer ............ 8
As an Object Measurement Thermometer ...... 10
1
MEMORY ......................................................... 11
Recalling the Memory ...................................... 11
Clear the memory ............................................ 11
MAINTENANCE ............................................... 12
Care & Cleaning ............................................... 12
FAULT INDICATION ......................................... 12
SYMBOL INFORMATION ................................ 13
SPECIFICATIONS ............................................ 14
DISPOSAL OF DEVICE .................................... 15
REFERENCE OF STANDARDS ........................ 15
Device Standards: ........................................... 15
Classication: .................................................. 15
Electromagnetic Compatibility: ....................... 15
WARRANTY ..................................................... 17
MANUFACTURER’S DECLARATION
OF THE EMC ................................................... 21
BEFORE YOU BEGIN
Cautions and Warnings
• As with any thermometer, proper technique is
crucial to obtaining accurate temperature readings. Please read this manual thoroughly and
carefully before using.
• Always operate the thermometer in an operating temperature range 10°C to 40°C (50°F to
104°F), and relative humidity15 to 95%.
• Always store the thermometer in a cool and dry
place -25°C to 55°C (-13°F to 131°F) and relative humidity 15% to 95%.
• The device requires no calibration. The product
has been calibrated before the factory inspection.
• The device contains no user serviceable parts.
• The user must check that the equipment functions safely and see that it is in proper working
condition before being use
• The manufacturer does not require such preventive inspections by other persons.
• No modication of this equipment is allowed.
• The device is not suitable for use in the presence of ammable anesthetic mixtures with air
or with oxygen or nitrous oxide.
• Manufacturer will provide circuit diagrams,
component part lists, descriptions, calibration
instructions to assist to SERVICE PERSONNEL
in parts repair.
• Do not clean or maintenance the device is in
use.
• Avoid direct sunlight.
• Avoid dropping the thermometer, if it happens
and you think the thermometer may be damaged, please contact customer services immediately.
• Do not touch the 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 substitute
for a consultation with your physician.
• This thermometer and the subject must remain
in a stable environment for at least 30 minutes
before measuring the temperature.
• When the measured temperature falls within the fever temperature range of ≥37.8°C
(100.04°F) and <42.9°C (109.22°F), as indicated by the red LED on display, please consult
with your physician immediately.
Restrictions of Use
This thermometer is clinically proven to produce
accurate temperature measurements. However,
please be advised that the accuracy can not
be ensured when the thermometer is not clean.
Check that the probe is clean before taking a
measurement.
Intended Use
A200 Infrared Thermometer is intended for the
intermittent measurement and monitoring of human body temperature from forehead measurement at home, clinics and hospital.
A control measurement using a conventional
thermometer is recommended in the following
cases:
1. If the reading is surprisingly low.
2. For new-born infants, up to 100 days old.
3. For children under three years of age who have
a weakened immune system or who react unusually in the presence or absence of fever.
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.
NOTE:
The thermometer does not emit any infrared energy.
Highlighted Features
• Measurement that does not require probe cover, thereby saving cost of replacement.
• Automatically power off if left idle for 30 seconds.
• Memory function allows you to recall previous
results up to 25 previous results.
• Easy to read LCD with green backlight in a dark
environment.
• Color visible of fever (red) and measurement in
progress (green).
Meter Overview
1. nfrared Sensor
2. Led Light
3. Display Screen
4. Measurement /
Memory Button
5. ON/OFF Button
6. Mode Switch
7. Battery Cover
Display Screen
1. Body mode indication
2. Object mode indication
3. Memory indication
4. Temperature reading
5. Temperature unit
6. Battery indication
Display Mode
Two modes can be selected.
1.Body Mode
This mode is used to
measure the forehead
temperature.
2.Object Mode
This mode is used to
measure the object temperature.
Select the Temperature Unit
This meter provides two measurement units
used for indicating the body/object temperature, °C or °F, for your preferred selection.
Be sure the thermometer
is OFF before selecting the
temperature unit.
5432
Long-press the Measurement Button for 5 seconds
until the signal -- °C or °F
displayed on the LCD panel
as gure shown. Re-press
the Measurement Button to
select °C or °F unit.
Turn ON/OFF the Led Light
This meter provides Led Light to help users
placing the thermometer at the correct position.
Be sure the thermometer is
OFF before turn ON/OFF the
Led Light.
1.
Long-press the Measurement Button for seconds
until Signal -- °C or °F displayed on the LCD panel.
2 Release the measurement
button, then short-press
the ON/OFF Button, the
signal -- Led or OFF will
displayed on the LCD panel as gure shown.
3 Quick press the measure-
ment button, and select
Led or OFF to turn ON/OFF
the Led Light
Replacing the Battery
The meter will display “ ” to alert you when
the meter power is getting low, please follow
the steps below to replace new batteries immediately.
.
1. Remove the battery cover as
the arrow direction accordingly.
2. Remove the old batteries
and replace with two 1.5V
AAA size alkaline batteries.
Taking care to match the
Positive ( + ) and Negative
( - ) indications
3. Close the battery cover as
the arrow direction accordingly.
NOTE:
1. Although the thermometer works when “ ”,
appearing, we still recommend that you
change the batteries to obtain an accurate result.
2. Remove the batteries if stored for a long period
of time.
3. The batteries should be kept away out of children’s reach.
If they are swallowed, promptly see a doctor
for help.
DETAILED INFORMATION
About Normal Body Temperature & Fever
The temperature in the forehead and temple area
differs from the internal temperature, which is
taken orally or rectally. Vasoconstriction, an effect which constricts the blood vessels and cools
the skin, can occur during the early stages of a
fever. In this case, the temperature measured by
the A200 Infrared thermometer may be unusually low. If the measurement therefore does not
match the patient’s own perception or is unusually low, repeat the measurement every 15 minutes. As a reference, you can also measure the
internal body temperature using a conventional
oral or rectal thermometer. Body temperature can
vary from one individual/person to next. It also
varies by location on the body and time of 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 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*1 Normal Temperature Range of various
body sites
Oral 0.6°C (1°F) or more above or be-
Rectal/ear 0.3°C to 0.6°C (0.5°F to 1°F)
Axillary
(armpit)
PERFORM THE TEST
As a Body Measurement Thermometer
low 37°C (98.6°F)
higher than oral temperature
0.3°C to 0.6°C (0.5°F to 1°F) lower than oral temperature
Press “ON/OFF” Button to turn
on the thermometer rst.
Push the Mode switch to select
Body mode.
The temperature unit ashes.
Move the probe close to the
forehead and take measurements
Make sure the probe is at and
close to the forehead, not at
an angle. Perform a forehead
measurement with a distance
within 3 cm.
Read the result.
The measurement result will be
done in 1 second. The reading
is shown together with LED
lighting and one long beep informs about the temperature
measurement, and after a while
another short beep, conrming
the saving of the result to the
memory and readiness for the
next measurement.
Press the “ON/OFF” button to turn off the unit,
or leave it idle for 30 seconds the unit will switch
off automatically.
NOTE:
• As the forehead measurement 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 close to the
forehead measurement, the reading will be
affected by surrounding temperature. Babies’
skin reacts very quickly to the ambient temperature. Therefore, do not take their temperature
with the A200 Infrared thermometer during or
after breastfeeding, because the skin temperature may then be lower than the internal body
temperature.
• If the measured temperature is < 32°C (89.6°F),
the display will show with LO symbol.
• If the reading is≥ 37.8°C (100.04°F) and <
42.9°C (109.22°F), the display will show together with red LED and six short beeps.
• The thermometer will automatically turn off if
left idle for 30 seconds.
As an Object Measurement Thermometer
Press “ON/OFF” Switch to turn
on the thermometer rst.
Push the Mode switch to select
Object mode.
The temperature unit ashes.
Move the probe close to the object and take measurements.
Make sure the probe is at and
close to the object, not at an angle. Perform a measurement with
a distance within 3 cm. When
ready, push measurement button
to take measurements.
Read the result.
The measurement result will be
done in 1 second. The reading is
shown together with LED lighting
and one long beep informs about
the temperature measurement,
and after a while another short
beep, conrming the saving of
the result to the memory and
readiness for the next measurement.
Press the “ON/OFF” button to turn off the unit,
or leave it idle for 30 seconds, the unit will switch
off automatically.
MEMORY
Recalling the Memory
This thermometer stores 25 most recent readings
Be sure the thermometer
is OFF before recalling this
memory.
Press to enter the memory mode.
Each time you press the
Memory Button, a result will
be displayed in the order of
dates (latest result shown
rst), together with “MEM”
and number (from 1 to 25).
LED in green or red will appear according to the memory reading.
When the memory is full, the
oldest result is deleted as
the new one added. When
the last record displayed in
the display, press Memory
Button again to return the
rst record.
Exit the memory.
Press ON/OFF Button to exit
the memory or keep the meter in idle for 30 seconds to
switch off automatically.
Clear the memory
Delete the record by unplugging the battery and power
off.
11109876
MAINTENANCE
Care & Cleaning
• The probe is not waterproof. Please wipe
with a clean and dry cotton swab to clean
the probe on the inside.
• 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.
FAULT INDICATION
FAULT OR
FAULT
SYMBOL
No display
On the LCD
pane
Measurement
not possible
(or an abnormal value is
displayed)
An abnormal
temperature
value is
displayed.
FAULT
DESCRIPTION
The battery has
run out. Incorrect
battery polarity.
The thermometer
is not ready.
The probe tip is
dirty or damaged.
Did you hear
the beep after
pressing the ON
button?
12
CORRECTIIVE
MEASURE
Replace the
battery.
Please note:
The (+) side
of the battery
must face
upwards.
Wait until the
°C symbol is
displayed.
Clean the
probe tip or
get it repaired.
Wait until you
hear the
beep before
removing the
thermometer
from the ear
or forehead
LO or HI
symbol is
displayed
is displayed
Symbol is
displayed
Symbol
The temperature
measured is
outside the
measuring
Range.
LO-temperature
<32°C (89.6°F).
HI-temperature ≥42.9°C
(109.22°F).
The battery has
run out.
The ambient
temperature
is outside the
operating
temperature
range or is
changing too
fast.
SYMBOL INFORMATION
Caution: read
instructions
(warnings) carefully
Keep in a cool, dry
place
Manufacturer
Product code Lot number
Follow instructions
for use
Serial number WEEE disposal
Authorized
representative
in the European
community
Check that
the probe
tip is clean
and that the
thermometer
is properly
placed on the
forehead.
Replace the
battery.
To ensure
accurate
measurement,
let the thermometer rest
at operating
temperature
for 30 minutes
prior to use.
Medical Device
complies with
Directive 93/42/
EEC
Keep away from
sunlight
Date of
manufacture
Type BF applied
part
SPECIFICATIONS
Model A200
Measurement
range
Display
resolution
Accuracy For body mode:
Indicator
light
Voice Power on and ready for working:
Memory Storage of 25 measurements
Operating
conditions
Air pressure 86Kpa-106Kpa
Storage and
transport
environment
Auto shut-off About 30 seconds after no using
Battery 2pcs 1.5V AAA Alkaline Battery
Size 170 x 47 x 53 mm
Weight 75g
Body/Forehead: 32.0~42.9°C
(89.6°F~109.22°F)
Object: 0.0°C to 99.9°C (32°F to
211.8°F)
0.1°C / 0.1°F
±0.2°C (±0.4°F) from36.0°C (96.8°F) to
39.0°C (102.2°F)
±0.3°C (±0.5°F) from 32.0°C (89.6°F)
to 35.9°C (96.6°F) and from 39.1°C
(102.4°F) to 42.9°C (109.22°F)
For object mode
±4°C (±7.2°F) from 0°C (32°C) to 4.9°C
(40.8°F)
±1°C (±2°F) from 5°F (41°C) to 60°C
(140.0°F)
±4°C (±7.2°F) from 60.1°C (140.1°F) to
100°C (212°F)
Green light for temperature lower than
37.8°C(100.4°F)
Red light for temperature higher than
37.8°C(100.4°F)
a short beep.
Measurement nished:
1 long beep equal or lower than 37.8°C
(100.4°F)
6 short beeps higher than 37.8°C
(100.4°F)
10°C to 40°C (50°F to 104°F),
Humidity: 15 to 95% R.H.
Temperature: -25°C to 55°C
(-13°F to 131°F)F
Storage humidity: 15% to 95% RH
REFERENCE OF STANDARDS
Device Standards:
Device Corresponds to the requirements of the
standard for infrared thermometers
IEC 60601-1-2: 2014
IEC 60601-1: 2012
ISO 80601-2-56: 2017
Classication:
Anti-electric Shock Type: Internally powered
equipment
Applied part: Type BF
Mode of operation: Continuous Operation
EMC: type B class I
Enclosure Degree of ingress protection: IP22
IP22 means shell of this product can withstand
the water dropping to the surface when the shell
deviate 15 degree from horizontal surface.
Electromagnetic Compatibility:
Device fullls the stipulations of the standard IEC
60601-1-2
The stipulations of EU-Directive 93/42/EEC for
Medical Devices Class II a have been fullled.
* Technical alterations reserved!
Software identify no.: A200 V1.1.0
WARRANTY
• This thermometer is guaranteed for 18 months
from the date of purchase against any manufacturing defect, conditional upon normal
household use.
• The intended service life of the product is 24
months.
• This product to be free of defects in workmanship and materials for a period on 18 months
from the date of purchase.
• During the warranty period, if this product is
found to be defective, you may bring it together with the purchase receipt and Warranty Certicate on a carry-in basis to manufacturer’s ofce during normal business hours for warranty
service.
• We will then repair or replace defective parts
or exchange the whole product as we select,
at no charge to the original owner. After such
repair, replacement or exchange, the product
will be warranted from the date of purchase.
• This warranty is valid only if the Warranty Certicate and Warranty Registration Card are
duly complete with date of purchase, serial
number and dealer’s stamp, and if the Warranty Registration Card is sent to local distributor
ofce not later than 14 days from the date of
purchase.
• This warranty is void if this product has been
repaired or serviced by unauthorized person.
This warranty does not cover defects caused
by misuse, abuse, accident, tampering, poor
maintenance, re or any other acts beyond human control.
• Except as stated in the above paragraphs,
A200 Infrared Thermometer disclaims all other warranties, implied or expressed, including
the warranties of merchantability of tness for
a particular purpose with respect to the use of
this product. Manufacturer shall not be liable
for any direct, consequential or incidental damages arising out of the use or inability to use
product.
MANUFACTURER’S DECLARATION
OF THE EMC
Guidance and manufacturer´s declaration –
electromagnetic emission – for all EQUIPMENT
AND SYSTEMS
Guidance and manufacturer´s declaration –
electromagnetic emission
The A200 Infrared Thermometer is intended for use in
the electromagnetic environment specied below. The
customer or the user of A200 Infrared Thermometer
should assure that it is used in such an environment.
Emissions
test
RF
emissions
CISPR 11
RF emissions
CISPR 11
Harmonic
emissions
IEC
61000-3-2
Voltage
uctuations
/ icker
emissions
IEC
61000-3-3
Guidance and manufacturer’s declaration –
electromagnetic immunity –for all EQUIPMENT
and SYSTEMS
Guidance and manufacturer´s declaration –
electromagnetic immunity
The A200 Infrared Thermometer is intended for use in
the electromagnetic environment specied below. The
customer or the user of the A200 Infrared Thermometer
should assure that it is used in such an environment.
Immunity
test
Compli-
Electromagnetic
ance
environment - guidance
Group 1 The A200 Infrared Ther-
mometer 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.
Class B The A200 Infrared Ther-
mometer is suitable for
use in all establishments,
including domestic estab-
N/A
lishments and those directly connected to the public
low-voltage power supply
network that supplies
N/A
buildings used for domestic purposes.
IEC 60601
Compliance
level
Electromagnetic
environment guidance
test level
1716151413
Electro-
± 8 kV
± 8 kV
static
contact
discharge
(ESD)
IEC
± 15 kV air
61000-4-2
Electro-
± 2 kV for
static
power
transient /
supply
burst
lines
IEC
± 1 kV
61000-4-4
for input/
output
lines
Surge
± 1 kV difIEC
ferential
61000-4-5
mode
± 2 kV
common
mode
Voltage
0% UT;
dips,
0,5 cycle
short
g)
interrup-
At 0°, 45°,
tions and
90°, 135°,
voltage
180°,
variations
225°, 270°
on power
and 315°
supply
0% UT;
input lines
1 cycle
IEC
and 70%
61000-
UT; 25/30
4-11
cycles
at 0°
0% UT;
250/300
cycle
Power
30 A/m 30 A/m Power frequency
frequency
(50/60 Hz)
magnetic
eld IEC
61000-4-8
NOTE UT is the a. c. mains voltage prior to application of the test level.
Guidance and manufacturer´s declaration –
electromagnetic immunity – for EQUIPMENT
and SYSTEM that are not LIFE-SUPPORTING
Floors should be
contact
wood, concrete or
ceramic tile. If
± 15 kV
oors are covered
air
with synthetic material, the relative
humidity should
be at least 30%.
N/A
Mains power
quality should be
that of a typical
commercial or
hospital
environment.
N/A
Mains power quality should be that
of a typical commercial or hospital
environment.
N/A Mains power qual-
ity should be that
of a typical commercial or hospital
environment. If the
user of the A200 Infrared Thermometer
requires continued
operation during
power mains
interruptions, it is
recommended that
the A200 Infrared
Thermometer be
powered from an
uninterruptible
power
magnetic elds
should be at levels
characteristic of
a typical location
in a typical commercial or hospital
environment.
Guidance and manufacturer´s declaration – electromagnetic immunity
The A200 Infrared Thermometer is intended for use in
the electromagnetic environment specied below. The
customer or the user of the A200 Infrared Thermometer
should assure that it is used in such an environment.
Immunity
IEC 60601
Compli-
test
Conducted
RF
IEC
61000-4-6
Radiated
RF
IEC
61000-4-3
test level
3 Vrms
150 kHz to
80 MHz
6Vrms in
ISM banda
between
150 kHz to
80 MHz
80 MHz to
2.7 GHz
ance level
N/A
10 V/m
Electromagnetic environment - guidance
Portable and mobile
RF communications
equipment should be
used no closer to any
part of the A200 Infrared Thermometer, including cables, than
the recommended separation distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
3.5
√P
d=
1
V
3.5
√P
d=
1
E
80 MHz to 800 MHz
7
√P
d=
1
E
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 metres
(m).b Field strengths
from xed RF transmitters, as determined
by an electromagnetic
site survey, a should
be less than the compliance level in each
frequency range.
Interference may occur in the vicinity of
equipment marked
with the following symbol:
b
NOTE 1 At 80 MHz and 800 MHz, the higher frequency
range applies.
NOTE 2 These guidelines may not apply in all situations.
Electromagnetic is affected by absorption and reection
from structures, objects and people.
a Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV
broadcast can not be predicted theoretically with accuracy.
To assess the electromagnetic environment due to xed
RF transmitters, an electromagnetic site survey should be
considered. If the measured eld strength in the location in
which the A200 Infrared Thermometer is used exceeds the
applicable RF compliance level above, the A200 Infrared
Thermometer should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re¬orienting or relocating
the A200 Infrared Thermometer.
b Over the frequency range 150 kHz to 80 MHz, eld
strengths should be less than 3V/m.
Recommended separation distances between
portable and mobile
RF communications equipment and the EQUIPMENT or SYSTEM -for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
Recommended separation distances between
portable and mobile RF communications equipment and the
A200 Infrared Thermometer
The A200 Infrared Thermometer is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of theA200 Infrared
Thermometer can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and theA200 Infrared Thermometer as recommended below, according to the
maximum output power of the communications equipment
Rated maximum output
of transmitter
W
Separation distance according to frequency
of transmitter m
150KHz
to 80MHz
d=
0.01 / 0.12 0.23
0.1 / 0.38 0.73
1 / 1.2 2.3
10 / 3.8 7.3
100 / 12 23
80MHz
to 800MHz
3.5
√P
d=
1
V
800MHz
to 2.5GHz
3.5
E
7
√P
d=
1
E
√P
1
For transmitters rated at a maximum output power not listed
above the recommended separation distance d in metres
(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.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for
the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and
reection from structures, objects and people.
Disposal: The product must not be disposed of along with other domestic waste.
The users must dispose of this equipment
by bringing it to a specic recycling point for
electric and electronic equipment.
M25582-GB-Rev.0-04.20
25582 / A200
Shenzhen Aeon Technology Co., Ltd.
RM6H02, Block 27-29,
Tianxia IC Industrial Park, Majialong,
No.133 of Yiyuan road, Nantou Street,
Nanshan District, Shenzhen, China
Made in China
Shanghai International
Trading Corp GmbH
Eiestrasse 80,
20537 Hamburg, Germany
232221201918
0123
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