Air Techniques ScanX Edge Series User manual

EN-
US
ScanX Edge
Installation and Operating Instructions
2160100287L41
*2160100287L41* G8302
1911V006

Contents
Important information
1About this document .. . . . . . . . . . . . . 3
1.1 Warnings and symbols .. . . . . . . 3
1.2 Copyright information .. . . . . . . . 4
2 Safety .. . . . . . . . . . . . . . . . . . . . . . . . . 5
2.1 Unauthorised modification .. . . . . 5
2.2 CE-Certification .. . . . . . . . . . . . . 5
2.3 FDA-Registration .. . . . . . . . . . . 5
2.4 General safety information .. . . . . 6
2.5 Specialist personnel .. . . . . . . . . 6
2.6 Protection from electric shock .. . 6
2.7 FCC note .. . . . . . . . . . . . . . . . . 6
2.8 Essential performance charac-
teristics .. . . . . . . . . . . . . . . . . . . 7
2.9 Notification requirement of seri-
ous incidents .. . . . . . . . . . . . . . . 7
2.10 Only use genuine parts .. . . . . . . 7
2.11 Transport .. . . . . . . . . . . . . . . . . . 7
2.12 Disposal .. . . . . . . . . . . . . . . . . . 7
2.13 Protection from cybersecurity
threats .. . . . . . . . . . . . . . . . . . . . 8
Product description
3Overview .. . . . . . . . . . . . . . . . . . . . . . . 9
3.1 Scope of delivery .. . . . . . . . . . . . 10
3.2 Accessories .. . . . . . . . . . . . . . . . 10
3.3 Optional items .. . . . . . . . . . . . . . 10
3.4 Consumables .. . . . . . . . . . . . . . 10
3.5 Wear parts and spare parts .. . . . 10
4Technical data .. . . . . . . . . . . . . . . . . . . 11
4.1 Imaging plate scanner .. . . . . . . . 11
4.2 Phosphor storage plate .. . . . . . . 14
4.3 Barrier envelope .. . . . . . . . . . . . 15
4.4 Model identification plate .. . . . . . 16
4.5 Conformity assessment .. . . . . . . 16
5 Function .. . . . . . . . . . . . . . . . . . . . . . . 16
5.1 Imaging plate scanner .. . . . . . . . 16
5.2 Cartridges (S0-S2) .. . . . . . . . . . . 17
5.3 Phosphor storage plate .. . . . . . . 18
5.4 Barrier envelope .. . . . . . . . . . . . 18
Installation
6 Requirements .. . . . . . . . . . . . . . . . . . . 19
6.1 Installation/setup room .. . . . . . . 19
6.2 System requirements .. . . . . . . . . 20
6.3 Monitor .. . . . . . . . . . . . . . . . . . . 21
7 Installation .. . . . . . . . . . . . . . . . . . . . . . 21
7.1 Setting up the unit .. . . . . . . . . . . 21
7.2 Electrical connection .. . . . . . . . . 22
7.3 Connecting the unit to the net-
work .. . . . . . . . . . . . . . . . . . . . . 23
8Commissioning and first start-up .. . . 24
8.1 Configuring the network .. . . . . . 24
8.2 Configuring the unit in VisionX .. . 25
8.3 Configuring the unit in DBSWIN .. 25
8.4 X-ray unit settings .. . . . . . . . . . . 27
8.5 Commissioning tests .. . . . . . . . . 28
Usage
9Correct use of phosphor storage
plates .. . . . . . . . . . . . . . . . . . . . . . . . . . 29
10 Operation .. . . . . . . . . . . . . . . . . . . . . . 30
10.1 Changing the input unit cartridge .. 30
10.2 X-ray .. . . . . . . . . . . . . . . . . . . . . 31
10.3 Scanning the image data .. . . . . . 33
10.4 Erasing the imaging plate .. . . . . 35
10.5 Switching the unit off .. . . . . . . . . 35
11 Cleaning and disinfection .. . . . . . . . . . 36
11.1 Imaging plate scanner .. . . . . . . . 36
11.2 Barrier envelope .. . . . . . . . . . . . 36
11.3 Phosphor storage plate .. . . . . . . 36
12 Maintenance .. . . . . . . . . . . . . . . . . . . . 37
12.1 Recommended maintenance
schedule .. . . . . . . . . . . . . . . . . . 37
12.2 Check image quality .. . . . . . . . . 37
Contents
2160100287L41 1911V006 1
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Troubleshooting
13 Tips for operators and service techni-
cians .. . . . . . . . . . . . . . . . . . . . . . . . . . 39
13.1 Poor X-ray image .. . . . . . . . . . . 39
13.2 Software error .. . . . . . . . . . . . . . 42
13.3 Fault on the unit .. . . . . . . . . . . . 43
Appendix
14 Scanning times .. . . . . . . . . . . . . . . . . . 45
15 File sizes (uncompressed) .. . . . . . . . . 46
16 Handover record .. . . . . . . . . . . . . . . . . 47
Contents
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Important information
1 About this document
These installation and operating instructions are
an integral part of the unit.
Air Techniques shall not be held liable and
offers no guarantees of the safe and
smooth operation of this unit if you fail to
comply with notes and instructions con-
tained in these Installation and Operating
Instructions.
The German version of the installation and oper-
ating instructions is the original manual. All other
languages are translations of the original manual.
These operating instructions are valid for the fol-
lowing ScanX Edge versions:
Item number:
– G8300 (2160100510)
– G8300J (2160100511)
– G8300K (2160100512)
– G8300C (2160100513)
1.1 Warnings and symbols
Warnings
The warning notes in this document highlight
possible injury to persons or damage to machin-
ery.
They are marked with the following warning sym-
bols:
General warning symbol
The warnings are structured as follows:
SIGNAL WORD
Description of type and source of
danger
Here you will find the possible conse-
quences of ignoring the warning
❯Follow these measures to avoid the
danger.
The signal word differentiates between different
levels of danger:
–DANGER
Direct danger of severe injury or death
–WARNING
Possible danger of severe injury or death
–CAUTION
Risk of minor injuries
–NOTICE
Risk of extensive material/property damage
Adhesive label
Fig. 1: Laser class 3B
Fig. 2: Warning - laser beams
Closed device: Laser class 1
Open device: Laser class 3B
Fig. 3: Specification of laser source
Important information
2160100287L41 1911V006 3
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Miscellaneous symbols
These symbols are used in the document and on
or in the unit:
Note, e.g. specific instructions regarding
the efficient use of the unit.
Part number
Serial number
Medical device
Health Industry Bar Code (HIBC)
CE mark
Manufacturer
Dispose of correctly in accordance with
EU Directive 2012/19/EU (WEEE).
Take note of the accompanying electronic
documents.
Refer to Operating Instructions.
Wear hand protection.
Disconnect all power from the unit.
Do not reuse
DC current
Non-ionizing electro-magnetic radiation
Warning – risk of dangerous electric volt-
ages
Warning - laser beams
Damage to components due to electro-
static discharges (ESD)
This way up / store and transport in an
upright position
Keep dry
n
Stacking limits
no condensation
XX
YY
Lower and upper humidity limits
XX
YY
Lower and upper temperature limits
XX
YY
Lower and upper atmospheric pressure
limits
Fragile, handle with care
Keep away from sunlight during storage
1.2 Copyright information
All electronic drawings, processes, names, soft-
ware, and appliances mentioned here are pro-
tected under copyright.
Printing or copying these Installation and Operat-
ing Instructions, including excerpts thereof, may
only be carried out with the written approval of
Air Techniques.
Important information
4 2160100287L41 1911V006
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2 Safety
The unit has been developed and designed
appropriately such that hazards are largely
excluded if the unit is used in accordance with its
Normal Use.
Therefore, please note the following.
Despite this, the following residual risks can
remain:
– Personal injury due to incorrect use/misuse
– Personal injury due to mechanical effects
– Personal injury due to electric shock
– Personal injury due to radiation
– Personal injury due to fire
– Personal injury due to thermal effects on the
skin
– Personal injury due to lack of hygiene, e.g.
infection
2.1 Unauthorised modification
Pursuant to Part 15.21 of the FCC rules, any
changes or modifications to this equipment not
expressly approved by Dürr Dental may cause,
harmful interference and void the FCC authoriza-
tion to operate this equipment.
2.2 CE-Certification
ScanX Edge
Intended purpose (CE)
The ScanX Edge is intended to be used for scan-
ning and processing digital images exposed on
Phosphor Storage Plates (PSPs) in dental appli-
cations.
Intended use (CE)
The unit may only be operated with accessories
and optional articles specified or approved by Air
Techniques.
The unit may be cleaned only with the disinfec-
tants and cleaning agents specified or approved
by Air Techniques.
Improper use
Any other usage or usage beyond this scope is
deemed to be improper. The manufacturer
accepts no liability for damages resulting from
improper usage. The user bears the sole risk.
This unit is not suitable for monitoring patients
over longer periods of time. This unit must not be
operated in operating theatres or similar rooms,
in which dangers may arise from the combustion
of flammable materials.
Barrier envelope
Intended purpose (CE)
Disposable Barrier Envelope are intended to be
used as a disposable barrier for the Air Tech-
niques Phosphor Storage Plates. The device is
non-sterile and intended for single patient use
only.
Indication for use
Disposable Barrier Envelope are intended to be
used as a disposable barrier for the Air Tech-
niques Phosphor Storage Plates. The device is
non-sterile and intended for single patient use
only.
2.3 FDA-Registration
ScanX Edge
Intended use
The ScanX Edge is intended to be used for scan-
ning and processing digital images exposed on
Phosphor Storage Plates (PSPs) in dental appli-
cations.
Contraindication
Any other usage or usage beyond this scope is
deemed to be improper. The manufacturer
accepts no liability for damage resulting from
improper usage. The user bears the sole risk.
This unit is not suitable for monitoring patients
over longer periods of time. This unit must not be
used in operating rooms, in which hazards may
arise from the combustion of flammable materi-
als.
Barrier envelope
Intended use (FDA)
Disposable Barrier Envelope are intended to be
used as a disposable barrier for the Air Tech-
niques Phosphor Storage Plates. The device is
non-sterile and intended for single patient use
only.
Indication for use
Disposable Barrier Envelope are intended to be
used as a disposable barrier for the Air Tech-
niques Phosphor Storage Plates. The device is
non-sterile and intended for single patient use
only.
Contraindication
This Device has no contraindications.
Important information
2160100287L41 1911V006 5
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2.4 General safety information
The sale or prescription of this device by a medi-
cal practitioner is subject to the restrictions of the
applicable Federal Acts. The device may be used
only under permanent supervision by a dentist or
licensed medical practitioner.
Caution: Federal law restricts this device
to sale by or on the order of a Doctor.
❯Comply with the guidelines, laws, rules and
regulations applicable at the site of operation
when you use this unit.
❯Prior to each use, check the function and
proper condition of the device.
❯Do not convert or modify the unit.
❯Comply with the Installation and Operating
Instructions.
❯Make the Installation and Operating Instruc-
tions always available to the operator in the
vicinity of the device.
2.5 Specialist personnel
Operation
Persons operating the unit must ensure safe and
correct handling based on their training and
knowledge.
❯Instruct or have every user instructed in han-
dling the unit.
Installation and repairs
❯All installation, resetting, alteration, expansion,
and repair work must be carried out either by
Air Techniques personnel or by a suitably quali-
fied person approved by Air Techniques.
2.6 Protection from electric
shock
❯Working on the unit, comply with all the rele-
vant electrical safety regulations.
❯Never touch the patient and unshielded plug
connections or metallic parts of the device at
the same time.
❯Immediately replace any damaged cables or
plugs.
Comply with the EMC rules concerning medi-
cal devices
❯The unit is intended for use in professional
healthcare facilities (in accordance with IEC
60601-1-2). If the unit is operated in any other
environment, potential effects on the electro-
magnetic compatibility must be taken into
account.
❯Do not use the device near HF surgical devices
and MRI equipment.
❯Keep a minimum distance of 30 cm between
the device and other electronical devices.
❯Keep a minimum distance of 30 cm between
the unit and portable and mobile radio devices.
❯Note that cable lengths and cable extensions
have effects on electromagnetic compatibility.
❯No maintenance measures are required to
maintain the basic EMC safety.
NOTICE
Negative effects on the EMC due to
non-authorized accessories
❯Use only Air Techniques accessories or
accessories approved by Air Tech-
niques.
❯Using any other accessories may result
in increased electromagnetic interfer-
ence emissions or the unit having
reduced electromagnetic immunity,
leading to an erroneous operation
mode.
NOTICE
Erroneous operation mode due to use
immediately adjacent to other devices
or with other stacked devices
❯Do not stack the unit together with
other devices.
❯If this is unavoidable, the unit and other
devices should be monitored in order
to ensure that they are working cor-
rectly.
2.7 FCC note
This equipment has been tested and found to
comply with the limits for a Class B digital device,
pursuant to part 15 of the FCC Rules. These lim-
its are designed to provide reasonable protection
against harmful interference in a residential instal-
lation. This equipment generates, uses and can
Important information
6 2160100287L41 1911V006
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radiate radio frequency energy and, if not
installed and used in accordance with the
instructions, may cause harmful interference to
radio communications. However, there is no
guarantee that interference will not occur in a
particular installation. If this equipment does
cause harmful interference to radio or television
reception, which can be determined by turning
the equipment off and on, the user is encouraged
to try to correct the interference by one or more
of the following measures:
❯Reorient or relocate the receiving antenna.
❯Increase the separation between the equip-
ment and receiver.
❯Connect the equipment into an outlet on a cir-
cuit different from that to which the receiver is
connected.
❯Consult the dealer or an experienced radio/TV
technician for help.
2.8 Essential performance char-
acteristics
The ScanX Edge does not have any essential
performance characteristics as set out in
IEC 60601-1 (EN 60601-1) section 4.3.
The unit meets the requirements according to
IEC 60601-1-2:2014.
2.9 Notification requirement of
serious incidents
The operator/patient has to report any serious
incident related the product to the manufacturer
and the competent authority of the Member
State, in which the operator and/or patient is
established/resident.
2.10 Only use genuine parts
❯Only Air Techniques accessories and special
accessories or those approved by Air Tech-
niques may be used.
❯Only use original spare and replacement parts.
Air Techniques accepts no liability for
damage resulting from the use of non-
approved accessories, special acces-
sories or any parts other than original
spare and wear parts.
The use of non-approved accessories,
special accessories or non-genuine work-
ing parts / spare parts (e.g. mains cable)
can have a negative effect on the electri-
cal safety and EMC.
2.11 Transport
Only the original packaging ensures optimum
protection for the unit during transport.
If necessary, the original packaging for this unit
can be ordered from Air Techniques.
Air Techniques cannot be held responsi-
ble for any damage resulting from trans-
port in unsuitable packaging, even during
the warranty period.
❯Only transport the unit in its original packaging.
❯Keep all packaging away from children.
❯Do not expose the unit to any strong vibrations
or shocks.
2.12 Disposal
Europe
An overview of the waste keys for Dürr
Dental products can be found in the
download area at www.duerrdental.com
(document no. P007100155).
Device
Dispose of the unit correctly. Within the
European Union, the unit must be dis-
posed of in accordance with EU Directive
2012/19/EU (WEEE).
❯If you have any questions about the correct
disposal of parts, please contact your dental
trade supplier.
Phosphor storage plate
The image plate contains barium compounds.
❯Dispose of the image plate properly in accor-
dance with locally applicable regulations.
❯In Europe, dispose of the image plate in accor-
dance with waste code 090199 "Waste not
otherwise specified". Disposal as domestic
waste is not possible.
Important information
2160100287L41 1911V006 7
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Rest of world
Disposal of the units, electronic circuitry and
PSPs must be accomplished only at the appro-
priate facilities for recovery and recycling. Make
sure to dispose of such items in accordance with
current federal, national, state and local govern-
ment rules and regulations.
2.13 Protection from cybersecurity
threats
The unit is to be connected to a computer that
can be connected to the Internet. Therefore, the
system needs to be protected from threats from
the Internet.
❯Use antivirus software and update it regularly.
Look for evidence of possible virus infection
and, if applicable, check with the antivirus soft-
ware and remove the virus.
❯Perform regular data backups.
❯Provide access to units only to trustworthy
users, e.g. by means of user name and pass-
word.
❯Make sure that only trustworthy contents are
downloaded. Install manufacturer-authenti-
cated software and firmware updates only.
Important information
8 2160100287L41 1911V006
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Product description
3 Overview
1
3
4
7
2
5
8
6
back
IDX
2
*+E247G36120/$+01234567L*
a
1 ScanX Edge phosphor storage plate scanner
2 Cartridge for phosphor storage plates (S0 to S2)
3 Phosphor storage plate IDX
4 Barrier envelope
5 VisionX imaging software DVD
6 DBSWIN imaging software DVD
7 Network cable (3 m)
8 Power supply unit with country-specific adapter
Product description
2160100287L41 1911V006 9
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3.1 Scope of delivery
The following items are included in the scope of
delivery (possible variations due to country-spe-
cific requirements and/or import regulations):
ScanX Edge
phosphor storage plate scanner sys-
tem .. . . . . . . . . . . . . . . . . . . . . . . . . . . G8300A
ScanX Edge
phosphor storage plate scanner
system .. . . . . . . . . . . . . . . . . . . . . . . . G8300AJ
ScanX Edge
phosphor storage plate scanner
system .. . . . . . . . . . . . . . . . . . . . . . . G8300AK
ScanX Edge
phosphor storage plate scanner
system .. . . . . . . . . . . . . . . . . . . . . . . G8300AC
– ScanX Edge basic unit
– Power supply
– Network cable (3 m)
– Collector mat (mounted in the device)
– VisionX imaging software DVD
– DBSWIN imaging software DVD
– Cartridge for phosphor storage plate size 2
– Phosphor storage plates IDX:
– Size 2
– Barrier envelopes:
– Size 2
– Installation and Operating Instructions
– Quick Start Guide
3.2 Accessories
The following items are required for operation of
the device, depending on the application:
Phosphor storage plates (PSPs)
– Phosphor storage plate IDX Size 0
– Phosphor storage plate IDX Size 1
– Phosphor storage plate IDX Size 2
Barrier envelopes
– Barrier envelope Size 0
– Barrier envelope Size 1
– Barrier envelope Size 2
3.3 Optional items
The following optional items can be used with the
device:
Wall mount .. . . . . . . . . . . . . . . . . . . . . . . G8321
Commissioning and intraoral constancy tests
2D X-ray test phantom .. . . . . . . . . . . . . . G8795
3.4 Consumables
The following materials are consumed during
operation of the device and must be re-ordered:
Cleaning and disinfection
PSP cleaning wipes (50 pieces) .. . . . . . . . B8910
Barrier envelopes
Barrier envelope Size 0
2 x 3 cm (100 pcs.) .. . . . . . . . . . . . . . . G8511-0
Barrier envelope Size 1
2 x 4 cm (100 pcs.) .. . . . . . . . . . . . . . . G8511-1
Barrier envelope Size 2
3 x 4 cm (300 pcs.) .. . . . . . . . . . . . . . . G8511-2
Barrier envelope Size 2
3 x 4 cm (1000 pcs.) .. . . . . . . . . . . . . G8511-2k
3.5 Wear parts and spare parts
Phosphor storage plates (PSPs)
Phosphor storage plate IDX Size 0 (2
pieces) .. . . . . . . . . . . . . . . . . . . . . . . . . . G3620
Phosphor storage plate IDX Size 1 (2
pieces) .. . . . . . . . . . . . . . . . . . . . . . . . . . G3621
Phosphor storage plate IDX Size 2 (4
pieces) .. . . . . . . . . . . . . . . . . . . . . . . . . . G3622
Phosphor storage plate IDX Size 2 (12
pieces) .. . . . . . . . . . . . . . . . . . . . . . . . . . G3631
Cartridges
Cartridge for phosphor storage plate
S0 .. . . . . . . . . . . . . . . . . . . . . . . . . . . . G8310-0
Cartridge for phosphor storage plate
S1 .. . . . . . . . . . . . . . . . . . . . . . . . . . . . G8310-1
Cartridge for phosphor storage plate
S2 .. . . . . . . . . . . . . . . . . . . . . . . . . . . . G8310-2
Product description
10 2160100287L41 1911V006
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4 Technical data
4.1 Imaging plate scanner
Electrical data for the device
Nominal voltage V DC 24
Max. current consumption A 0.5
Max. power consumption W < 12
Electrical data of the power supply unit
Nominal input voltage V AC 100 - 240
Frequency Hz 50/60
Nominal output voltage V DC 24
Max. output current A 0.5
General technical data
Dimensions (W x H x D) mm 167 x 231 x 216
in 6.57 x 9.09 x 8.50
Weight kg approx. 4
lb approx. 8.82
Duty Cycle % 100
Max. theoretical resolution Line
pairs/mm
(Lp/mm)
approx. 16.7
Noise level
During scanning dB(A) approx. 45
Network connection
LAN technology Ethernet
Standard IEEE 802.3u
Data rate Mbit/s 100
Connector RJ45
Type of connection Auto MDI-X
Type of cable ³CAT5
Ambient conditions during operation
Temperature °C +10 to +35
°F +50 to +95
Relative humidity % 20 - 80
Air pressure hPa 750 - 1060
Elevation above sea level m < 2000
ft < 6562
Product description
2160100287L41 1911V006 11
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Ambient conditions during storage and transport
Temperature °C -18 to +60
°F -4 to +140
Humidity % 10 - 95, non-condensing
Air pressure hPa 500 - 1060
Classification
Medical device of class Class I
FDA classification (CFR Title 21) Class II
Laser class (unit)
In accordance with IEC 60825-1
1
Laser source
Laser class
In accordance with IEC 60825-1:2014
3B
Wavelength lnm 635
Output mW <10
Technical data of the RFID module
Frequency MHz 13.56
Modulation ASK
Max. power mW 400
Electromagnetic compatibility (EMC)
Interference emission measurements
High-frequency emissions in accordance with CISPR 11 Group 1
Class B
Interference voltage at the power supply connection
CISPR 11:2009+A1:2010 Conforms
Electromagnetic interference radiation
CISPR 11:2009+A1:2010 Conforms
Electromagnetic compatibility (EMC)
Interference immunity measurements on cover
Immunity to interference by discharge of static electricity
IEC 61000-4-2:2008
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
Conforms
Immunity to interference by high-frequency electromag-
netic fields
IEC 61000-4-3:2006+A1:2007+A2:2010
3 V/m
80 MHz - 2.7 GHz
80 % AM at 1 kHz
Conforms
Product description
12 2160100287L41 1911V006
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Electromagnetic compatibility (EMC)
Interference immunity measurements on cover
Immunity to interference by near fields of wireless HF
communication devices
IEC 61000-4-3:2006+A1:2007+A2:2010
See Table on immunity levels with respect to near fields of
wireless HF communication devices
Conforms
Immunity levels with respect to near fields of wireless HF communication devices
Radio service Frequency band
MHz
Test level
V/m
TETRA 400 380 - 390 27
GMRS 460
FRS 460 430 - 470 28
LTE band 13, 17 704 - 787 9
GSM 800/900
TETRA 800
iDEN 820
CDMA 850
LTE band 5
800 - 960 28
GSM 1800
CDMA 1900
GSM 1900
DECT
LTE bands 1, 3, 4, 25
UMTS
1700 - 1990 28
Bluetooth
WLAN 802.11 b/g/n
RFID 2450
LTE band 7
2400 - 2570 28
WLAN 802.11 a/n 5100 - 5800 9
Electromagnetic compatibility (EMC)
Interference immunity measurements on supply input
Immunity to interference by rapid transient bursts – AC
voltage grid
IEC 61000-4-4:2012
± 2 kV
100 kHz repetition frequency
Conforms
Immunity to interference, surges
IEC 61000-4-5:2005
± 0.5 kV, ± 1 kV
Conforms
Product description
2160100287L41 1911V006 13
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Electromagnetic compatibility (EMC)
Interference immunity measurements on supply input
Immunity to interference, line-conducted disturbances
induced by high-frequency fields – AC voltage grid
IEC 61000-4-6:2013
3 V
0.15 - 80 MHz
6 V
ISM frequency bands
0.15 - 80 MHz
80 % AM at 1 kHz
Conforms
Immunity to interference due to voltage dips, short inter-
ruptions and voltage fluctuations
IEC 61000-4-11:2004
Conforms
Electromagnetic compatibility (EMC)
Interference immunity measurements SIP/SOP
Immunity to interference by discharge of static electricity
IEC 61000-4-2:2008
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
Conforms
Immunity to electrical fast transients/bursts – I/O,
SIP/SOP ports
IEC 61000-4-4:2012
± 1 kV
100 kHz repetition frequency
Conforms
Immunity to conducted disturbances, induced by radio-
frequency fields – SIP/SOP ports
IEC 61000-4-6:2013
3 V
0.15 - 80 MHz
6 V
ISM frequency bands
0.15 - 80 MHz
80 % AM at 1 kHz
Conforms
4.2 Phosphor storage plate
Classification
Medical Devices of class Class IIa
FDA classification (CFR Title 21) Class I
Ambient conditions during operation
Temperature °C 18 - 45
°F 64 - 113
Relative humidity % < 80
Product description
14 2160100287L41 1911V006
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Ambient conditions during storage and transport
Temperature °C < 33
°F < 91
Relative humidity % < 80
Dimensions of intraoral phosphor storage plates
Size 0 mm 22 x 35
inch 0.86 x 1.38
Size 1 mm 24 x 40
inch 0.94 x 1.57
Size 2 mm 31 x 41
inch 1.22 x 1.61
4.3 Barrier envelope
Classification
Medical Devices Directive Class I
FDA classification (CFR Title 21) Class II
Product description
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4.4 Model identification plate
The model identification plate is located on the
rear of the device.
REF Order number
SN Serial number
4.5 Conformity assessment
This device has been subjected to conformity
acceptance testing in accordance with the cur-
rent relevant guidelines of the European Union.
This equipment conforms to all relevant require-
ments.
Dürr Dental herewith declares that the radio
equipment "ScanX Edge" meets the require-
ments of Directive 2014/53/EC.
5 Function
5.1 Imaging plate scanner
2
3
4
1
1 Input unit
2 Cover (open)
3 User interface
4 Collection tray
The phosphor storage plate scanner is used to
read image data stored on a phosphorus storage
plate and to transfer the data to an imaging soft-
ware (e. g. VisionX) on a computer.
The transport mechanism guides the PSP
through the unit. A laser in the scanner unit scans
the PSP. The scanned data is converted into a
digital image and transferred to the imaging soft-
ware.
After scanning, the PSP runs through the erasure
unit. Image data still present on the PSP is
erased with the aid of bright light.
The PSP is then ejected for re-use.
Product description
16 2160100287L41 1911V006
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Operating elements
8
5
1
4 3 2
7
6
1 On/off switch
2 Error display yellow
3 Read display blue
4 Green status LED
5 Communication/standby display white
6 Display for cartridge S0
7 Display for cartridge S1
8 Display for cartridge S2
The status LEDs display the following status
messages:
Device starts
Communication display
Standby
Ready to scan
PSP currently being processed
Cartridge for PSP missing
Error
A message is displayed in the soft-
ware
S0 Cartridge for PSP S0 is inside the
device
S1 Cartridge for PSP S1 is inside the
device
S2 Cartridge for PSP S2 is inside the
device
Status LED flashes
Connections
The connections are located on the rear of the
unit, underneath the cover.
1
2
3
1 Network connection
2 Reset button
3 Connection for power supply unit
5.2 Cartridges (S0-S2)
Depending on the PSP used, the proper car-
tridge for the size of the PSP must be inserted in
the device. The cartridge that is currently inside
the device is indicated via the LEDs on the
device.
Product description
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5.3 Phosphor storage plate
The PSP stores X-ray energy, which is re-emitted
in the form of light after excitation by the laser.
This light is then converted into image informa-
tion in the phosphor storage plate scanner.
The PSP has an active side and an inactive side.
The PSP must always be exposed on the active
side.
When used properly, a PSP can be exposed,
read and erased several hundred times provided
there is no mechanical damage. The PSP must
be replaced if there are any signs of damage, e.g.
if the protective layer is damaged or there are vis-
ible scratches that could interfere with the diag-
nostics.
Inactive side Active side
back
IDX
2
*+E247G36120/$+01234567L*
a
a
White, with "back",
size and manufac-
turer's information
printed on it
Light blue, with posi-
tioning aid a
Positioning aid ais visible on the x-ray image and
makes orientation easier during diagnosis.
Only use phosphor storage plate IDX with
the unit. The unit is unable to read any
other types of PSP.
5.4 Barrier envelope
Disposable Barrier Envelope are intended to be
used as a disposable barrier for the Air Tech-
niques Phosphor Storage Plates. The device is
non-sterile and intended for single patient use
only.
Product description
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