Carestream Health 5850 Laser Imager with 13.56 MHz RFID User Manual 2G0734 tpg

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Document ID	1114061
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Document Description	User Manual 1
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Document Type	User Manual
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Date Submitted	2009-05-21 00:00:00
Date Available	2009-05-21 00:00:00
Creation Date	2007-02-14 15:02:58
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Document Title	2G0734_tpg.fm
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Document Author:	L486095

KODAK DRYVIEW 5800 Laser Imager
and
CARESTREAM DRYVIEW 5850 Laser Imager
H221_0017
Safety Manual
Carestream Health, Inc.
150 Verona Street
Rochester, New York 14608
© Carestream Health, Inc., 2009
DRYVIEW is a trademark of Carestream Health, Inc.
The Kodak trademark and trade dress are used under license from Kodak.
Pub No. 2G0734
Rev. C
Table of Contents
Safety and Related Information - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -1
Safety, Warnings, and Cautions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -1
Safety Labels - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -5
Safety and Health Compliance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10
Safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10
EMC - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11
EU Directives - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16
CE Marking - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16
Please Note - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17
Imager Specifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17
February 27, 2009
2G0734
Safety and Related Information
Safety, Warnings, and Cautions
Please read and understand all instructions before using this
product.
RISK OF ELECTRIC SHOCK:
This equipment is operated with hazardous voltage which can
shock, burn, or cause death.
•
Remove wall plug before servicing equipment. Never pull on
cord to remove from outlet. Grasp plug and pull to disconnect.
Do not attempt to service or repair the laser imager yourself to
avoid exposure to dangerous voltage, laser beam, or other danger.
Always call an Authorized Service Provider of Carestream
Health, Inc. products for any service or repair.
•
•
•
Do not operate equipment with a damaged power cord.
•
•
•
Position the power cord so it will not be tripped over or pulled.
Do not use an extension cord to power this equipment.
Do not operate equipment with any of the safety interlocks
overridden.
Connect this equipment to a grounded wall outlet.
Three power cord sets are provided with this equipment:
– power cord with plug for use in North America
– power cord with plug for use in China
– power cord with plug for use in Europe
All other countries must use an Agency-approved power
cord with a plug type suitable for the country of use, or
contact an authorized Carestream Health, Inc. dealer.
DANGER: This equipment contains moving parts that may be
accessible to the user. Loose clothing, jewelry or long
hair may cause personal injury or damage to the
equipment.
• Do not operate equipment with the covers open.
DANGER: This equipment is not contained in a sealed cabinet.
Do not use this equipment in locations where it can
come in contact with liquids, including body fluids.
February 27, 2009
2G0734
Safety and Related Information
CAUTION:
Double pole/neutral fusing.
CAUTION:
Do not use a cell phone within 2 meters of a laser imager. This
proximity includes any imager behind a wall adjacent to your
location.
CAUTION:
Do not use a microwave oven within 4 meters of a laser
imager. Electromagnetic radiation from a microwave oven is
only an issue if after the oven door is closed and latched, the
seal does not maintain an electromagnetic tight fit between the
oven door and oven main housing. Determining if the seal has
an electromagnetic tight fit requires special detection
equipment.
CAUTION:
Do not use in the presence of flammable anesthetics, oxygen,
or nitrous oxide. This equipment does not have a gas-sealed
electronics enclosure and could ignite any flammable or
explosive gases present in its environment.
CAUTION:
This equipment uses a DICOM network port, and is intended
to connect to other medical devices. It is not intended to be
connected directly outside the building. Only an Authorized
Service Provider of Carestream Health, Inc., products or
customer’s qualified service personnel may perform
installation and service maintenance.
1.83 m
CAUTION:
This device is NOT to be located within the patient
environment. Therefore, the equipment must not be located
closer than 1.83 meters from a patient bed or chair.
2G0734
February 27, 2009
Safety and Related Information
CAUTION:
This device should not be used in close contact with MRI
devices, due to possible very high magnetic fields near an MRI
unit. The magnetic field in the area where this equipment is
installed must be less than 50 Gauss.
CAUTION:
Do not substitute or modify any part of this equipment without
prior written approval of Carestream Health, Inc.
CAUTION:
Federal law prohibits dispensing without a prescription.
CAUTION:
This equipment has been tested and found to comply with the
limits for a Class A digital device, pursuant to part 15 of the
FCC Rules. These limits are designed to provide reasonable
protection against harmful interference when the equipment is
operated in a commercial environment. This equipment
generates, uses, and can radiate radio frequency energy and, if
not installed and used in accordance with the User Guide and
other User Documentation, may cause harmful interference to
radio communications. Operation of this equipment in a
residential area is likely to cause harmful interference in which
case the user will be required to correct the interference at his
own expense.
CAUTION:
Changes or modifications not expressly approved by the party
responsible for compliance could void the user’s authority to
operate the equipment.
CAUTION:
Do not use isopropyl alcohol to clean the exterior surfaces of
the laser imager. Isopropyl alcohol can dissolve the exterior
paint on the laser imager.
CAUTION:
In the U.S., exhausted filters are considered to be
non-hazardous waste according to the US Environmental
Protection Agency Resource Conservation Recovery Act
(RCRA). Municipality owned and licensed solid waste
management facilities are an appropriate disposal option.
Contact your local or state solid waste authorities to determine
if additional disposal requirements apply. In other regions,
contact local or regional solid waste authorities for proper
disposal guidance.
February 27, 2009
2G0734
Safety and Related Information
CAUTION:
Lithium batteries should only be replaced by an Authorized
Service Provider of Carestream Health, Inc. products. The
laser imager uses a lithium battery to power the clock and
calendar circuitry. THERE IS A DANGER OF EXPLOSION
IF THE BATTERY IS REPLACED INCORRECTLY. The
battery must be replaced only with the same or equivalent
type. The U.S. EPA’s RCRA does not regulate disposal of this
lithium battery. Users should discard spent batteries in
municipal trash unless their community offers a battery
collection program. In other regions, contact local or regional
solid waste authorities for proper disposal guidance.
LASER WARNING:
The Equipment uses a 50-Milliwatt invisible laser. Laser
radiation may be present when the machine operates without the
rear cover installed. Covers with this label may only be removed
by an Authorized Service Provider of Carestream Health, Inc.
products. USE OF CONTROLS OR OTHER ADJUSTMENTS,
OR OTHER PERFORMANCE OF PROCEDURES OTHER
THAN THOSE SPECIFIED HEREIN, MAY RESULT IN EYE
DAMAGE.
2G0734
February 27, 2009
Safety and Related Information
Safety Labels
Safety labels are attached to the laser imager in compliance with
international standards.
English Text on Labels
Some names on the labels are shortened and left in English. Below is a key to
understand the meanings of the shortened words on the safety labels:
Symbol on label
Definition
Belt Path
Processor Drive Belt
Turn Around Belt
Transport Drive Belt
Media Path
Model Number
Serial Number
CAT Number
Manufactured Date
February 27, 2009
2G0734
Safety and Related Information
Symbol on label
Definition
Manufactured By
Sorter Belt Path
Sorter Drive Belt
Tension Drive Belt
Lower Drive-Roller Belt
Main Drive Belt
Cooling Roller Drive Belt
Processor Belt Path
Short Drive Belt
Cooling Section Drive Belt
2G0734
February 27, 2009
Safety and Related Information
Symbol on label
Definition
Long Drive Belt
Drum Drive Belt
Labels - Locations and
Details
NOTE: The labels vary between the 5800 Laser Imager and the 5850
Laser Imager, but the compliance information is the same for both
imagers. See “Safety and Health Compliance” on page 10 for the
specific details of the safety and health compliance.
DryView Laser Imager, 5800
DryView 5800
5800
580000022
JANUARY - 2008
01/08/24
100 - 120 / 200 - 240 V ac
8623730
8/4
8623720
50/60
L NO
FILE NO CNTL
E311346
3JZT
N16887
CARESTREAM HEALTH, INC.
Rochester, NY 14608
Made in USA
74-9999-9120-6. H
This label shows the serial number and model number of the Imager
along with other important data items.
February 27, 2009
2G0734
Safety and Related Information
Laser Radiation Warning Labels
Class 3B invisible laser radiation. This label states that,
"When open and interlocks defeated, avoid exposure to the
beam."
Laser Hazard symbol.
U.S., Canada,
and Japan
Rest of World
Agency Statements
Hazardous Voltage. This warning label indicates that high
voltage is present under panels where the label is attached. Only
an Authorized Service Provider of Carestream Health, Inc.
products should attempt access.
2G0734
February 27, 2009
Safety and Related Information
Static Sensitive Equipment. This label identifies
static-sensitive components. Connect a personal grounding strap
to appropriate ground before servicing this laser imager. These
panels may only be removed by an Authorized Service Provider
of Carestream Health, Inc. products.
Radio Frequency Energy. This label indicates that the laser
imager can radiate radio frequency energy. If not installed and
used in accordance with the instructions, the laser imager may
cause harmful interference to radio communications.
Class 1 Laser. This label indicates that the laser imager
complies with IEC requirements for Class 1 systems.
Japanese Import License.
Hot Surface Labels
February 27, 2009
Processor cover hot surface. This label indicates to use care
near the processor drum to avoid possible burns.
Processor heat shield hot surface. This label indicates to use
care near the processor heat shield to avoid possible burns.
2G0734
Safety and Related Information
Safety and Health Compliance
This equipment has been tested for, and complies with, the following
Safety and Emissions Standards. Certificates of Compliance and
Declarations of Conformity have been issued as shown below.
Safety
United States
21 CFR 1040.10 Class I
Code of Federal Regulations Title 21 Food and Drugs
Chapter I Food and Drug Administration, Department of Health and
Human Services
Volume 8 - Parts 800 to 1299
Subchapter J - Radiology Health
Part 1040 - Performance Standards for Light Emitting Products
Section 10 - Laser Products
FDA 21CFR 807 Premarket Notification 510(K): Regulatory
Requirements For Medical Devices.
UL 60950-1: Safety of Information Technology Equipment, including
Electrical Business Equipment (Bi-National Standard).
IEC 60601-1: Medical electrical equipment - Part 1: General
requirements for safety - Section 1: Collateral standard: Safety
requirements for medical electrical systems, Clause 19.
IEC 60825-1: Safety of laser products - Part 1: Equipment
classification, requirements and user’s guide.
10
2G0734
February 27, 2009
Safety and Related Information
Canada
CAN/CSA - C22.2 NO 60950-1-03 Information Technology
Equipment - Safety - Part 1: General Requirements. (Bi-National
Standard, with UL 60950-1).
IEC 60601-1: Medical electrical equipment - Part 1: General
requirements for safety, Clause 19.
IEC 60825-1: Safety of laser products - Part 1: Equipment
classification, requirements and user’s guide.
Europe
EN60950-1: Safety of Information Technology Equipment, including
Electrical Business Equipment (IEC 60950: 1991, Modified) (Includes
Amendment A1, A2, A3, A4, and A11).
EN60601-1: Medical electrical equipment - Part 1: General
requirements for safety, Clause 19.
EN60825-1: Safety of laser products - Part 1: Equipment
classification, requirements and user's guide.
Rest of World
IEC 60950-1: Safety of information technology equipment.
IEC 60601-1: Medical electrical equipment - Part 1: General
requirements for safety, Clause 19.
IEC 60825-1: Safety of laser products - Part 1: Equipment
classification, requirements and user's guide.
EMC
United States
FCC Rules and Regulations, Title 47, Part 15, Subpart B, Class A:
Radio Frequency Devices: Unintentional Radiators.
This equipment has been tested and been found to comply with the
limits for a Class A digital device pursuant to part 15 of the FCC rules.
Those limits are designed to provide reasonable protection against
harmful interference in a residential installation.
FCC Rules and Regulations, Title 47, Part 15, Subpart C, Radio
Frequency Devices: Intentional Radiators. FCC ID for 5800 Laser
Imager: U725800; FCC ID for 5850: U725850
February 27, 2009
2G0734
11
Safety and Related Information
Canada
CAN/CSA-C108.6-M91, Class A: Limits and Methods of
Measurement of Electromagnetic Disturbance Characteristics of
Industrial, Scientific and Medical (ISM) Radio-Frequency
Equipment.
Intentional Radiation IC for 5800 Laser Imager: 7027A-5800
Intentional Radiation IC for 5850 Laser Imager: 7027A-5850
This Class A digital apparatus complies with Canadian ICES-003.
CET APPAREIL NUM ENRIQUE DE CLASSE A EST
CONFORME A LA NORME NMB-003 DU CANADA.
This Class A digital apparatus meets all requirements of the Canadian
Interference-Causing Equipment Regulations.
Europe and the Rest of World
Guidance and Manufacturer’s Declaration for Electromagnetic Emissions
The 5800 and 5850 Laser Imagers are intended for use in the electromagnetic environment specified
below. The customer or user of the 5800 and 5850 Laser Imagers should ensure that it is used in such an
environment.
Emissions Test
Compliance
Electromagnetic Environment - Guidance
RF emissions:
Group 1
The 5800 and 5850 Laser Imagers use 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 A
The 5800 and 5850 Laser Imagers are suitable for use in all
establishments other than domestic and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Class A
The 5800 and 5850 Laser Imagers are suitable for use
everywhere, including those establishments directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Complies
The 5800 and 5850 Laser Imagers are suitable for use
everywhere, including those establishments directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
• EN55011
• CISPR 11
RF emissions:
• EN55011
• CISPR 11
Harmonics emissions:
• EN61000-3-2
• IEC 61000-3-2
Voltage fluctuations and
flicker emissions:
• EN61000-3-3
• IEC 61000-3-3
12
2G0734
February 27, 2009
Safety and Related Information
Guidance and Manufacturer’s Declaration for Electromagnetic Immunity
The 5800 and 5850 Laser Imagers are intended for use in the electromagnetic environment specified below.
The customer or user of the Laser Imager should ensure that it is used in such an environment.
Immunity Test
IEC 60601 Test
Level
Compliance Level
Electromagnetic Environment Guidance
Electrostatic
discharge (ESD):
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood, concrete,
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30%.
± 2 kV for power
supply lines
± 1 kV for
input/output lines
± 2 kV for power
supply lines
± 1 kV for input/output
lines
Mains power quality should be
that of a typical commercial or
hospital environment.
± 1 kV differential
mode
± 2 kV common
mode
± 1 kV differential
mode
± 2 kV common mode
Mains power quality should be
that of a typical commercial or
hospital environment.
<5% Ut* (>95% dip
in Ut*) for 0.5 cycle
40% Ut* (60% dip in
Ut*) for 5 cycles
70% Ut* (30% dip in
Ut*) for 25 cycles
<5% Ut* (>95% dip
in Ut*) for 5 sec.
<5% Ut* (>95% dip in
Ut*) for 0.5 cycle
40% Ut* (60% dip in
Ut*) for 5 cycles
70% Ut* (30% dip in
Ut*) for 25 cycles
<5% Ut* (>95% dip in
Ut*) for 5 sec.
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the Laser Imager requires
continued operation during power
mains interruptions, it is
recommended that the 5800 and
5850 Laser Imagers are powered
from an uninterruptible power
supply or a battery.
3 A/m
3 A/m
Mains power quality should be
that of a typical commercial or
hospital environment.
• EN61000-4-2
• IEC 61000-4-2
Electrical fast
transient/burst:
• EN61000-4-4
• IEC 61000-4-4
Surge:
• EN61000-4-5
• IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
lines:
• EN61000-4-11
• IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field:
• EN61000-4-8
• IEC 61000-4-8
NOTE: * Ut is the a.c. mains voltage prior to application of the test level.
February 27, 2009
2G0734
13
Safety and Related Information
Guidance and Manufacturer’s Declaration for Electromagnetic Immunity
The 5800 and 5850 Laser Imagers are intended for use in the electromagnetic environment specified below.
The customer or user of the Laser Imager should ensure that it is used in such an environment.
Immunity Test
IEC 60601 Test
Level
Compliance
Level
Electromagnetic Environment - Guidance
Portable and mobile RF communications
equipment should be used no closer to any part
of the 5800 and 5850 Laser Imagers, including
cables, than the recommended separation
distance calculated from the equation applicable
to the frequency of the transmitter.
Conducted RF
3 Vrms
IEC 61000-4-6
150 kHz to 80 MHz
Radiated RF
3 v/m
IEC 61000-4-3
80 MHz to 2.5 GHz
3 Vrms
d = 1.17 P
3 v/m
d = 1.17 P
d = 2.33 P
80 MHz to 800 MHz
800 MHz to 2.5 GHz
d is the recommended separation distance in
meters (m).
P is the maximum output rating of the transmitter
in watts (W) according to the transmitter
manufacturer.
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:
At 80 MHz and 800 MHz, the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.
a See Note 1 on next page.
b See Note 2 on next page.
14
2G0734
February 27, 2009
Safety and Related Information
Guidance and Manufacturer’s Declaration for Electromagnetic Immunity
Note 1
Field strengths from fixed transmitters, such as base station 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 the 5800 and 5850 Laser
Imagers are used exceeds the applicable RF compliance level above, the Laser Imagers
should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the Laser Imager.
Note 2
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 v/m.
Recommended separation distance between portable and mobile RF communications equipment and
the 5800 and 5850 Laser Imagers
The 5800 and 5850 Laser Imagers are intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of the Laser Imager can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communication equipment (transmitters) and the Laser Imager as recommended below, according to the
maximum output of the communications equipment.
Rated maximum
output power of
transmitter (P) in
Watts (W)
Separation distance (d) according to frequency of transmitter in meters (m)
150 kHz to 80 MHz
80 MHz to 800 MHz
d = 1.17 P
d = 1.17 P
800 MHz to 2.5 GHz
d = 2.33 P
0.01
0.1
10
100
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.
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 reflection from structures, objects, and people.
February 27, 2009
2G0734
15
Safety and Related Information
EU Directives
93/42/EEC Title: Council Directive Concerning Medical Devices.
99/05/EEC Title: Council Directive Concerning Radio and
Telecommunications Terminal Equipment.
73/23/EEC Title: Council Directive on the Harmonization of the Laws
of Member States Relating to Electrical Equipment Designed for Use
within Certain Voltage Limits.
89/336/EEC Title: Council Directive on the Approximation of the Laws
of the Member States Relating to Electromagnetic Compatibility.
Recycling Label
In the European Union, this symbol indicates that when the last user
wishes to discard this product, it must be sent to appropriate facilities
for recovery and recycling. Contact your local authorized representative
for additional information.
CE Marking
Documents concerning the conformance of this product to Council
Directive 93/42/EEC of 14 June 1993 concerning Medical Devices can
be obtained from the Carestream Health, Inc. European
Representative at:
Carestream Health France
LES MERCURIALES
40, rue Jean Jaures
93176 BAGNOLET CEDEX
16
2G0734
February 27, 2009
Safety and Related Information
Please Note
The information contained herein is based on the experience and knowledge
relating to the subject matter gained by Carestream Health, Inc. prior to
publication. No patent license is granted by this information. Carestream Health,
Inc. reserves the right to change this information without notice and makes no
warranty, express or implied, with respect to this information. Carestream Health,
Inc. shall not be liable for any loss or damage, including consequential or special
damages, resulting from the use of this information, even if loss or damage is
caused by the negligence of Carestream Health, Inc. or other fault.
Imager Specifications
See the Site Readiness for the KODAK DRYVIEW 5800 Laser Imager and the
CARESTREAM DRYVIEW 5850 Laser Imager, 2G0735.
February 27, 2009
2G0734
17
Safety and Related Information
Publication History
Revision
18
Date
January 14, 2008
October 31, 2008
February 27, 2009
2G0734
Reason for Change
First release
Updated labels for Italian
requirements.
Incorporated details for 5850 Laser
Imager.
February 27, 2009
Carestream Health, Inc.
150 Verona Street
Rochester, New York 14608
© Carestream Health, Inc., 2009
DRYVIEW is a trademark of Carestream Health, Inc.
The Kodak trademark and trade dress are used under license from Kodak.
Pub No. 2G0734
Rev. C

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