Durr Dental VistaScan Mini Easy 2.0 User manual

VistaScan Mini Easy 2.0
XPS07.1D...
EN Installation and operating instructions
2144100118L02 2208V002

https://qr.duerrdental.com/2144100118

Contents
Important information
1About this document .. . . . . . . . . . . . . 3
1.1 Warnings and symbols .. . . . . . . 3
1.2 Copyright information .. . . . . . . . 4
2 Safety .. . . . . . . . . . . . . . . . . . . . . . . . . 4
2.1 Intended purpose .. . . . . . . . . . . 4
2.2 Intended use .. . . . . . . . . . . . . . . 4
2.3 Improper use .. . . . . . . . . . . . . . . 5
2.4 General safety information .. . . . . 5
2.5 Specialist personnel .. . . . . . . . . 5
2.6 Electrical safety .. . . . . . . . . . . . . 5
2.7 Essential performance charac-
teristics .. . . . . . . . . . . . . . . . . . . 6
2.8 Notification requirement of seri-
ous incidents .. . . . . . . . . . . . . . . 6
2.9 Only use original parts .. . . . . . . . 6
2.10 Transport .. . . . . . . . . . . . . . . . . . 6
2.11 Disposal .. . . . . . . . . . . . . . . . . . 6
2.12 Protection from threats from the
Internet .. . . . . . . . . . . . . . . . . . . 7
Product description
3Overview .. . . . . . . . . . . . . . . . . . . . . . . 8
3.1 Scope of delivery .. . . . . . . . . . . . 9
3.2 Accessories .. . . . . . . . . . . . . . . . 9
3.3 Optional items .. . . . . . . . . . . . . . 9
3.4 Consumables .. . . . . . . . . . . . . . 9
3.5 Wear parts and replacement
parts .. . . . . . . . . . . . . . . . . . . . . 10
4Technical data .. . . . . . . . . . . . . . . . . . . 11
4.1 Image plate scanner
(XPS07.1D...) .. . . . . . . . . . . . . . . 11
4.2 Image plate .. . . . . . . . . . . . . . . . 14
4.3 Light protection cover .. . . . . . . . 15
4.4 Type plate .. . . . . . . . . . . . . . . . . 16
4.5 Evaluation of conformity .. . . . . . 16
4.6 Simplified declaration of con-
formity .. . . . . . . . . . . . . . . . . . . . 16
5 Operation .. . . . . . . . . . . . . . . . . . . . . . 16
5.1 Image plate scanner .. . . . . . . . . 16
5.2 Image plate .. . . . . . . . . . . . . . . . 17
5.3 Light protection cover .. . . . . . . . 18
5.4 Protective cover .. . . . . . . . . . . . 18
5.5 Image plate storage box .. . . . . . 18
5.6 Bite protector (optional) .. . . . . . . 18
Assembly
6 Requirements .. . . . . . . . . . . . . . . . . . . 19
6.1 Installation/setup room .. . . . . . . 19
6.2 System requirements .. . . . . . . . . 19
6.3 Monitor .. . . . . . . . . . . . . . . . . . . 19
7 Installation .. . . . . . . . . . . . . . . . . . . . . . 19
7.1 Setting up the unit .. . . . . . . . . . . 19
7.2 Electrical connections .. . . . . . . . 20
7.3 Connecting the device to the
network .. . . . . . . . . . . . . . . . . . . 21
8 Commissioning .. . . . . . . . . . . . . . . . . . 23
8.1 Configuring the network .. . . . . . 23
8.2 Configuring the unit .. . . . . . . . . . 23
8.3 Security settings .. . . . . . . . . . . . 23
8.4 Testing the device .. . . . . . . . . . . 23
8.5 X-ray unit settings .. . . . . . . . . . . 25
8.6 Acceptance tests .. . . . . . . . . . . 25
Usage
9Correct use of image plates .. . . . . . . . 27
10 Operation .. . . . . . . . . . . . . . . . . . . . . . 28
10.1 Switch on the unit. .. . . . . . . . . . 29
10.2 Changing the plate guide .. . . . . 29
10.3 X-ray .. . . . . . . . . . . . . . . . . . . . . 30
10.4 Scanning the image data via a
computer .. . . . . . . . . . . . . . . . . . 32
10.5 Erasing the image plate .. . . . . . . 33
10.6 Switch off the unit. .. . . . . . . . . . 33
11 Cleaning and disinfection .. . . . . . . . . . 34
11.1 Image plate scanner .. . . . . . . . . 34
Contents
2144100118L02 2208V002 EN | 1

11.2 Light protection cover .. . . . . . . . 35
11.3 Image plate .. . . . . . . . . . . . . . . . 35
11.4 Protective cover .. . . . . . . . . . . . 35
11.5 Image plate storage box .. . . . . . 35
12 Maintenance .. . . . . . . . . . . . . . . . . . . . 37
12.1 Recommended maintenance
schedule .. . . . . . . . . . . . . . . . . . 37
Troubleshooting
13 Tips for operators and service techni-
cians .. . . . . . . . . . . . . . . . . . . . . . . . . . 38
13.1 Poor X-ray image .. . . . . . . . . . . 38
13.2 Software error .. . . . . . . . . . . . . . 42
13.3 Fault on the unit .. . . . . . . . . . . . 43
13.4 Error message on display .. . . . . 45
Appendix
14 Scanning times .. . . . . . . . . . . . . . . . . . 47
15 File sizes (uncompressed) .. . . . . . . . . 48
16 Handover record .. . . . . . . . . . . . . . . . . 49
17 Country representatives .. . . . . . . . . . . 50
Contents
2 | EN 2144100118L02 2208V002

Important information
1 About this document
These installation and operating instructions rep-
resent part of the unit.
If the instructions and information in these
installation and operating instructions are
not followed, Dürr Dental will not be able
to offer any warranty or assume any liabil-
ity for the safe operation and the safe
functioning of the unit.
The German version of the installation and oper-
ating instructions is the original manual. All other
languages are translation of the original manual.
These operating instructions apply to:
VistaScan Mini Easy 2.0, order number:
2144100500 (XPS07.1D1)
1.1 Warnings and symbols
Warnings
The warnings in this document are intended to
draw your attention to possible injury to persons
or damage to machinery.
The following warning symbols are used:
General warning symbol
The warnings are structured as follows:
SIGNAL WORD
Description of the 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 four levels
of danger:
–DANGER
Immediate 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
Other symbols
These symbols are used in the document and on
or in the unit:
Note, e.g. specific instructions regarding
efficient and cost-effective use of the unit.
Order number
Serial number
Medical device
Lot designation
Model number
CE labelling
Conformity mark for the United Kingdom
of Great Britain and Northern Ireland
Manufacturer
Date of manufacture
Dispose of correctly in accordance with
EU Directive 2012/19/EU (WEEE).
Refer to the accompanying electronic
documents.
Observe the operating instructions.
Refer to Operating Instructions.
Wear protective gloves.
Disconnect all power from the unit.
Do not reuse
Health Industry Bar Code (HIBC)
Important information
2144100118L02 2208V002 EN | 3

DC current
Warning – dangerous high voltage
Warning - laser beam
This way up / store and transport in an
upright position
Keep dry
n
Stacking limits
xx %
xx %
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
1.2 Copyright information
All circuits, processes, names, software pro-
grams and units mentioned in this document are
protected by copyright.
The Installation and Operating Instructions must
not be copied or reprinted, neither in full nor in
part, without written authorisation from Dürr Den-
tal.
2 Safety
Dürr Dental has designed and constructed this
unit so that when used properly and for the inten-
ded purpose it does not pose any danger to
people or property.
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 skin
– Personal injury due to lack of hygiene, e.g.
infection
2.1 Intended purpose
VistaScan Mini Easy 2.0
The unit is intended exclusively for use in dental
applications for the scanning and processing of
image data on an image plate.
Light protection cover
The functions of the Light Protection Cover are:
– to protect the image plate from light and there-
fore against accidental erasure
– to protect against cross-contamination
2.2 Intended use
VistaScan Mini Easy 2.0
The unit may only be operated using accessories
and optional articles manufactured by or branded
with Dürr Dental.
The unit may only be cleaned using the disinfec-
tants and cleaning agents approved by and
specified by the manufacturer.
Light protection cover
The Light Protection Cover is a disposable item.
The Light Protection Cover is designed exclu-
sively for use with image plate scanners manu-
factured by or branded with Dürr Dental and
image plates manufactured by or branded with
Dürr Dental.
Important information
4 | EN 2144100118L02 2208V002

2.3 Improper use
VistaScan Mini Easy 2.0
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.
Light protection covers
Any other usage or usage beyond this scope is
deemed to be improper. The manufacturer
accepts no liability for damages resulting from
improper usage. In these cases the user/operator
will bear the sole risk.
Especially:
– The multiple use of this accessory and reproc-
essing contrary to the instructions of the man-
ufacturer.
The use of the accessory in combination with
other than image plate scanners manufactured
by or branded with Dürr Dental and image plates
manufactured by or branded with Dürr Dental.
2.4 General safety information
❯Always comply with the specifications of all
guidelines, laws, and other rules and regula-
tions applicable at the site of operation for the
operation of this unit.
❯Check the function and condition of the unit
prior to every use.
❯Do not convert or modify the unit.
❯Comply with the specifications of the Installa-
tion and Operating Instructions.
❯The Installation and Operating Instructions
must be accessible to all operators of the unit
at all times.
2.5 Specialist personnel
Operation
Unit operating personnel 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
❯Installation, readjustments, alterations,
upgrades and repairs must be carried out by
Dürr Dental or by qualified personnel specifi-
cally approved and authorized by Dürr Dental.
2.6 Electrical safety
❯Comply with all the relevant electrical safety
regulations when working on the unit.
❯Never touch the patient and unshielded plug
connections or metallic parts of the device at
the same time.
❯Replace any damaged cables or plugs immedi-
ately.
Observe the EMC rules concerning medical
devices
❯The unit is intended for use in professional
healthcare facilities (in accordance with IEC
60601-1-2). If the appliance is operated in
another environment, potential effects on elec-
tromagnetic compatibility must be taken into
account.
❯Do not operate the unit in the vicinity of HF sur-
gical instruments or MRT equipment.
❯Maintain a minimum distance of at least 30 cm
between the unit and other electronic devices.
❯Note that cable lengths and cable extensions
have effects on electromagnetic compatibility.
❯No maintenance measures are required to
maintain the EMV basic safety.
NOTICE
Negative effects on the EMC due to
non-authorised accessories
❯Use only Dürr Dental parts or accesso-
ries specifically approved by Dürr Den-
tal.
❯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.
Important information
2144100118L02 2208V002 EN | 5

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.
NOTICE
Reduced performance characteristics
due to insufficient distance between
unit and portable HF communication
devices
❯Keep a distance of at least 30 cm
between the unit (including parts and
cables of the unit) and portable HF
communication devices (wireless units)
(including their accessories such as
antenna cables and external anten-
nas).
2.7 Essential performance char-
acteristics
The VistaScan Mini Easy 2.0 unit does not have
any essential performance characteristics as set
out in IEC 60601--1 (EN 60601--1) section 4.3.
The unit complies with the requirements accord-
ing to IEC 60601-1.
The unit complies with the requirements accord-
ing to IEC 60601-1-2:2014.
2.8 Notification requirement of
serious incidents
The operator/patient is required to report any
serious incident that occurs in connection with
the device to the manufacturer and to the com-
petent authority of the Member State in which
the operator and/or patient is established/resi-
dent.
2.9 Only use original parts
❯Only use accessories and optional items that
have been recommended or specifically
approved by Dürr Dental.
❯Only use only original wear parts and replace-
ment parts.
Dürr Dental accepts no liability for dam-
ages or injury resulting from the use of
non-approved accessories or optional
accessories, or from the use of non-origi-
nal wear parts or replacement parts.
The use of non-approved accessories,
optional accessories or non-genuine wear
parts / replacement parts (e.g. mains
cables) can have a negative effect in
terms of electrical safety and EMC.
2.10 Transport
The original packaging provides optimum protec-
tion for the unit during transport.
If required, original packaging for the unit can be
ordered from Dürr Dental.
Dürr Dental will not accept any responsi-
bility or liability for damage occurring dur-
ing transport due to the use of incorrect
packaging, even where the unit is still
under guarantee.
❯Only transport the unit in its original packaging.
❯Keep the packing materials out of the reach of
children.
❯Do not expose the unit to any strong vibrations
or shocks.
2.11 Disposal
An overview of the waste keys for Dürr
Dental products can be found in the
download area:
http://qr.duerrdental.com/P007100155
Unit
The unit must be disposed of properly.
Within the European Union, the unit must
be disposed 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.
Important information
6 | EN 2144100118L02 2208V002

Image plate
The image plate contains barium compounds.
❯Dispose of the image plate properly in accord-
ance with the locally applicable regulations.
❯In Europe, dispose of the image plate in
accordance with waste code 20 03 01 "Mixed
municipal waste".
2.12 Protection from threats from
the Internet
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.
❯Restrict access to units to trustworthy users,
e.g. via a user name and password.
❯Make sure that only trustworthy content is
downloaded. Only install software and firmware
updates that have been authenticated by the
manufacturer.
Important information
2144100118L02 2208V002 EN | 7

Product description
3 Overview
back
IQ
2
*+E24721301042100/$+01234567F*
5
1
3
4
6
2
7
1 VistaScan Mini Easy 2.0 image plate scanner
2 Plate guides (S0 and S2)
3 VistaScan IQ image plate
4 VistaScan Light protection cover Plus
5 Network cable (3 m)
6 Image plate storage box
7 Power supply unit with country-specific adapter
Product description
8 | EN 2144100118L02 2208V002

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):
VistaScan Mini Easy 2.0
image plate scanner .. . . . . . . . . . 2144110001
– VistaScan Mini Easy 2.0 basic unit
– Power supply unit
– Network cable (3 m)
– Cover over device terminals
– Voucher for VistaSoft imaging software
– Plate guides:
– S0
– S2 (mounted on unit)
– IQ image plates:
– S0
– S2
– Light protection covers Plus:
– S0
– S2
– Image plate storage box
– Image Plate Cleaning Wipe
– Protective cover
– Quick start instructions
3.2 Accessories
The following items are required for operation of
the device, depending on the application:
Image plates
– Image plate IQ S0
– Image plate IQ S1
– Image plate IQ S2
– Image plate IQ S3
– Image plate IQ S4
Light protection covers
– Light protection cover Plus S0
– Light protection cover Plus S1
– Light protection cover Plus S2
– Light protection cover Plus S3
– Light protection cover Plus S4
– Light protection cover Plus S0, white
– Light protection cover Plus S2, white
3.3 Optional items
The following optional items can be used with the
unit:
VistaScan Smart Reader .. . . . . . . . 2162100005
Wall bracket .. . . . . . . . . . . . . . . . . . 2144100021
Image Plate Storage Case .. . . . . . 2141-002-00
Plate guide tray .. . . . . . . . . . . . . . . 2144100079
Image plate and film holder system
set .. . . . . . . . . . . . . . . . . . . . . . . . . 2130100015
Image plate and film holder system
conversion set for endo-exposures .. 2130100014
Bite protector S4 (100 each) .. . . . . 2130-074-03
Mobile Connect (for using apps
for mobile appliances, e.g. Dürr
Dental Imaging iPad app) .. . . . . 2100-725-12FC
Commissioning and intraoral constancy tests
Intra / extra digital test body .. . . . . 2121-060-54
3.4 Consumables
The following materials are consumed during
operation of the device and must be reordered
separately:
Cleaning and disinfection
Image plate cleaning wipes
(10 pcs.) .. . . . . . . . . . . . . . . . . . CCB351B1001
FD 333 forte wipes for quick-
acting disinfection .. . . . . . . . . . . CDF33FW0150
FD 350 Classic
disinfection wipes .. . . . . . . . . . . CDF35CA0140
FD 333
rapid surface disinfection .. . . . . . CDF333C6150
FD 322
rapid surface disinfection .. . . . . . CDF322C6150
FD 366 rapid disinfectant for
sensitive surfaces .. . . . . . . . . . . . CDF366C6150
ID 212
Instrument disinfection .. . . . . . . . CDI212C6150
ID 212 forte
Instrument disinfection .. . . . . . . . . CDI212F6150
ID 213
Instrument disinfection .. . . . . . . . CDI213C6150
Light protection covers
Light protection cover Plus S0
2 x 3 cm (100 each) .. . . . . . . . . . . 2130-080-00
Light protection cover Plus S1
2 x 4 cm (100 each) .. . . . . . . . . . . 2130-081-00
Light protection cover Plus S2
3 x 4 cm (100 each) .. . . . . . . . . . . 2130108251
Light protection cover Plus S2
3 x 4 cm (300 each) .. . . . . . . . . . . 2130-082-00
Light protection cover Plus S2
3 x 4 cm (1000 each) .. . . . . . . . . . 2130-082-55
Product description
2144100118L02 2208V002 EN | 9

Light protection cover Plus S3
2.7 x 5.4 cm (100 each) .. . . . . . . . 2130-083-00
Light protection cover Plus S4
5.7 x 7.6 cm (100 each) .. . . . . . . . 2130-084-00
Light protection cover Plus S0,
white
2 x 3 cm (100 each) .. . . . . . . . . . . 2130-080-50
Light protection cover Plus S2,
white
3 x 4 cm (300 each) .. . . . . . . . . . . 2130-082-50
3.5 Wear parts and replacement
parts
Image plates
VistaScan IQ Pack S0
Image Plate IQ S0 (2 each)
Light protection cover Plus S0
(1000 each) .. . . . . . . . . . . . . . . . . . 2130106051
VistaScan IQ Pack S1
Image Plate IQ S1 (2 each)
Light protection cover Plus S1
(1000 each) .. . . . . . . . . . . . . . . . . . 2130106151
VistaScan IQ Pack S2
Image Plate IQ S2 (2 each)
Light protection cover Plus S2
(1000 each) .. . . . . . . . . . . . . . . . . . 2130106251
VistaScan IQ Pack S3
Image Plate IQ S3 (2 each)
Light protection cover Plus S3
(1000 each) .. . . . . . . . . . . . . . . . . . 2130106351
VistaScan IQ Pack S4
Image Plate IQ S4 (1 each)
Light protection cover Plus S4
(100 each) .. . . . . . . . . . . . . . . . . . . 2130106451
Plate guides
Plate guide S0 (1 each) .. . . . . . . . . 2144100187
Plate guide S1 (1 each) .. . . . . . . . . 2144100188
Plate guide S2 (1 each) .. . . . . . . . . 2144100189
Plate guide S3 (1 each) .. . . . . . . . . 2144100193
Plate guide S4 (1 each) .. . . . . . . . . 2144100194
Information about replacement parts is
available from the portal for authorised
specialist dealers at:
www.duerrdental.net
Product description
10 | EN 2144100118L02 2208V002

4 Technical data
4.1 Image plate scanner (XPS07.1D...)
Electrical data for the device
Voltage V DC 24
Max. current consumption A 1.25
Output W < 30
Type of protection IP20
Electrical data – power supply unit
Nominal input voltage V AC 100 - 240
Frequency Hz 50/60
Nominal output voltage V DC 24
Max. output current A 1.25
General technical data
Dimensions (W x H x D) mm 211 x 249 x 258
in 8.31 x 9.80 x 10.16
Weight kg approx. 5.1
lb approx. 11.24
Pixel size (selectable) μm 12.5 - 50
Max. theoretical resolution Line
pairs/mm
(Lp/mm)
approx. 40
Network connection
LAN technology Ethernet
Standard IEEE 802.3u/IEEE 802.3ab
Data rate Mbit/s 100/1000
Connector RJ45
Type of connection Auto MDI-X
Cable type ³CAT5e
Ambient conditions during operation
Temperature °C +10 to +35
°F +50 to +95
Relative humidity % 20 - 80
Air pressure hPa 750 - 1060
Height above sea level m < 2000
ft < 6562
Product description
2144100118L02 2208V002 EN | 11

Ambient conditions during storage and transport
Temperature °C -20 to 60
°F -4 to +140
Relative humidity % 10 - 95
Air pressure hPa 750 - 1060
Classification
Medical Device Class (MDR) I
Laser class (unit)
In accordance with IEC 60825-1:2014
1
Laser source
Laser class
In accordance with IEC 60825-1:2014
3B
Wavelength lnm 639
Output mW <12
Technical data for 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 Compliant
Electromagnetic interference radiation
CISPR 11:2009+A1:2010 Compliant
Electromagnetic compatibility (EMC)
Interference immunity measurements cover
Immunity to interference, discharge of static electricity
IEC 61000-4-2:2008
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
Compliant
Immunity to interference, high-frequency electromagnetic
fields
IEC 61000-4-3:2006+A1:2007+A2:2010
3 V/m
80 MHz - 2.7 GHz
80 % AM at 1 kHz
Compliant
Product description
12 | EN 2144100118L02 2208V002

Electromagnetic compatibility (EMC)
Interference immunity measurements cover
Immunity to interference, near fields of wireless HF com-
munication devices
IEC 61000-4-3:2006+A1:2007+A2:2010
See immunity to interference table, near fields of wireless
HF communication devices
Compliant
Immunity to interference table, 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 band 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 supply input
Immunity to interference, rapid transient bursts – AC volt-
age grid
IEC 61000-4-4:2012
± 2 kV
100 kHz repetition frequency
Compliant
Immunity to interference, surges
IEC 61000-4-5:2005
± 0.5 kV, ± 1 kV
Compliant
Product description
2144100118L02 2208V002 EN | 13

Electromagnetic compatibility (EMC)
Interference immunity measurements 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
Compliant
Immunity to interference due to voltage dips, short inter-
ruptions and voltage variations
IEC 61000-4-11:2004
Compliant
Electromagnetic compatibility (EMC)
Interference immunity measurements SIP/SOP
Immunity to interference, discharge of static electricity
IEC 61000-4-2:2008
± 8 kV contact
± 2kV, ± 4 kV, ± 8 kV, ± 15 kV air
Compliant
Immunity to interference, rapid transient bursts – I/O,
SIP/SOP ports
IEC 61000-4-4:2012
± 1 kV
100 kHz repetition frequency
Compliant
Immunity to interference, line-conducted disturbances
induced by high-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
Compliant
4.2 Image plate
Classification
Medical Device Class (MDR) IIa
Ambient conditions during operation
Temperature °C 18 - 45
°F 64 - 113
Relative humidity % < 80
Product description
14 | EN 2144100118L02 2208V002

Ambient conditions during storage and transport
Temperature °C < 45
°F < 113
Relative humidity % < 80
Dimensions of intraoral image plates
S0 mm 22 x 35
in 0.87 x 1.38
S1 mm 24 x 40
in 0.94 x 1.57
S2 mm 31 x 41
in 1.22 x 1.61
S3 mm 27 x 54
in 1.06 x 2.13
S4 mm 57 x 76
in 2.24 x 2.99
4.3 Light protection cover
Classification
Medical Device Class (MDR) I
Product description
2144100118L02 2208V002 EN | 15

4.4 Type plate
The type plate is located on the rear of the
device.
REF Order number
SN Serial number
4.5 Evaluation of conformity
This device has been subjected to conformity
acceptance testing in accordance with the cur-
rent relevant European Union guidelines. This
equipment conforms to all relevant requirements.
4.6 Simplified declaration of con-
formity
The manufacturer hereby declares that the unit
complies with Directive 2014/53/EU as well as
others.
The full text of the EU declaration of conformity
can be viewed online at the Download Center:
https://qr.duerrdental.com/conformity
5 Operation
5.1 Image plate scanner
12
3
1 Plate guides:
2 User interface and display
3 Collection tray
The image plate scanner is used to read image
data stored on an image plate and to transfer the
data to the imaging software (e.g. VistaSoft) on a
computer.
The transport mechanism guides the image plate
through the device. The image plate is read using
a laser inside the scanner unit. The scanned data
is converted into a digital image and transferred
to the imaging software.
After scanning, the image plate runs through the
erasure unit. Image data still held on the image
plate is erased with the aid of bright light.
The image plate is then ejected for re-use.
Product description
16 | EN 2144100118L02 2208V002

Operating elements
132
1 On / off switch
2Confirm button
3 Display
On / off switch
The on / off switch shows different states of the
unit:
Unit off
To start simply press the on / off
switch.
The unit switches on or is ready for use
The start screen appears as soon as
the unit can be used.
Confirm button
The Confirm button is used to confirm messages
on the display. The button flashes when a mes-
sage requiring confirmation is displayed.
Display
The display shows information provided by the
imaging software.
Connections
The connections are located on the rear of the
unit, underneath the cover.
1
2
3
4
1 USB port (additional accessory)
2 Network connection
3 Reset button
4 Connection for power supply unit
5.2 Image plate
The image plate stores X-ray energy, which is re-
emitted in the form of light after excitation via the
laser. This light is then converted to image infor-
mation in the image plate scanner.
The image plate has an active side and an inac-
tive side. The image plate must always be
exposed on the active side.
When used properly, image plates can be
exposed, read and erased several hundred times
provided there is no mechanical damage. The
image plate must be replaced if there are any
signs of damage, e.g. if the protective layer is
damaged or there are visible scratches that could
interfere with the diagnosis.
Product description
2144100118L02 2208V002 EN | 17

Intraoral
Inactive side Active side
back
IQ
2
*+E24721301042100/$+01234567F*
White, printed with the
word "back" and the
size and manufactur-
er's information
Light blue, with posi-
tioning aid
The positioning aid is visible on the X-ray
image and makes it easier to align the image cor-
rectly during diagnosis.
Use only IQ image plates with the unit.
The unit is unable to read any other types
of image plates.
5.3 Light protection cover
The light protection cover protects the image
plate against light.
5.4 Protective cover
The protective cover protects the device against
dust and dirt, e. g. during extended periods in
which it is not in use.
5.5 Image plate storage box
Image plates packed in light protection covers
can be stored in the image plate storage box
until the next use. The image plate storage box
protects the image plate and the light protection
cover against contamination and dirt.
5.6 Bite protector (optional)
The bite protector protects the image plate S4 as
well as the light protection cover against heavy
mechanical damage, e. g. If the patient bites
down too hard during the X-ray exposure.
Product description
18 | EN 2144100118L02 2208V002