Durr Dental VistaScan Mini View User manual

EN
1908V007
2142100002L02

Installation and operating instructions
VistaScan Mini View

2142100002L02 1908V007 1
5.6 Storage box . . . . . . . . . . . . . . . . . 20
5.7 Bite protector (optional) . . . . . . . . . 21
Assembly
6 Requirements . . . . . . . . . . . . . . . . . . . . 22
6.1 Installation/setup room . . . . . . . . . 22
6.2 System requirements . . . . . . . . . . 22
6.3 Monitor . . . . . . . . . . . . . . . . . . . . . 22
7 Installation . . . . . . . . . . . . . . . . . . . . . . 22
7.1 Carrying the unit . . . . . . . . . . . . . . 22
7.2 Setting up the unit . . . . . . . . . . . . . 22
7.3 Removing the protective film from
the touch screen . . . . . . . . . . . . . . 23
7.4 Attaching the stylus . . . . . . . . . . . . 23
7.5 Checking the memory card . . . . . . 23
7.6 Electrical connections . . . . . . . . . . 23
7.7 Connecting the device to the net-
work . . . . . . . . . . . . . . . . . . . . . . . 24
8 Commissioning. . . . . . . . . . . . . . . . . . . 25
8.1 Installing and configuring the unit . 25
8.2 X-ray unit settings . . . . . . . . . . . . . 28
8.3 Acceptance tests . . . . . . . . . . . . . 29
Usage
9 Operating the touch screen . . . . . . . . . 30
9.1 Navigating. . . . . . . . . . . . . . . . . . . 30
9.2 Using menus . . . . . . . . . . . . . . . . . 30
9.3 Entering text in the field . . . . . . . . . 30
9.4 Calling up messages on the
touch screen . . . . . . . . . . . . . . . . . 31
10 Correct use of image plates . . . . . . . . . 32
11 Operation . . . . . . . . . . . . . . . . . . . . . . . 33
11.1 X-ray . . . . . . . . . . . . . . . . . . . . . . . 33
11.2 Scanning the image data via a
computer . . . . . . . . . . . . . . . . . . . 35
11.3 Scanning image data via the
touch screen on the unit . . . . . . . . 36
11.4 Erasing the image plate . . . . . . . . . 38
11.5 Switch off the unit. . . . . . . . . . . . . 39
12 Cleaning and disinfection. . . . . . . . . . . 40
12.1 Image plate scanner . . . . . . . . . . . 40
EN
Contents
Important information
1 About 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 character-
istics . . . . . . . . . . . . . . . . . . . . . . . . 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
3 Overview. . . . . . . . . . . . . . . . . . . . . . . . . 8
3.1 Scope of delivery . . . . . . . . . . . . . 10
3.2 Accessories . . . . . . . . . . . . . . . . . 10
3.3 Optional items . . . . . . . . . . . . . . . . 10
3.4 Consumables . . . . . . . . . . . . . . . . 10
3.5 Wear parts and replacement
parts . . . . . . . . . . . . . . . . . . . . . . . 11
4 Technical data . . . . . . . . . . . . . . . . . . . 12
4.1 Image plate scanner . . . . . . . . . . . 12
4.2 Image plate . . . . . . . . . . . . . . . . . . 15
4.3 Light protection cover . . . . . . . . . . 16
4.4 Type plate . . . . . . . . . . . . . . . . . . . 17
4.5 Evaluation of conformity . . . . . . . . 17
5 Operation . . . . . . . . . . . . . . . . . . . . . . . 17
5.1 Image plate scanner . . . . . . . . . . . 17
5.2 Image plate . . . . . . . . . . . . . . . . . . 19
5.3 Light protection cover . . . . . . . . . . 20
5.4 Stylus . . . . . . . . . . . . . . . . . . . . . . 20
5.5 Protection cover . . . . . . . . . . . . . . 20

2 2142100002L02 1908V007
Contents
12.2 Light protection cover . . . . . . . . . . 41
12.3 Image plate . . . . . . . . . . . . . . . . . . 41
12.4 Protection cover . . . . . . . . . . . . . . 41
12.5 Storage box with image plate
storage tray . . . . . . . . . . . . . . . . . 41
12.6 Stylus . . . . . . . . . . . . . . . . . . . . . . 42
13 Maintenance. . . . . . . . . . . . . . . . . . . . . 43
13.1 Recommended maintenance
schedule . . . . . . . . . . . . . . . . . . . . 43
Troubleshooting
14 Tips for operators and service techni-
cians. . . . . . . . . . . . . . . . . . . . . . . . . . . 44
14.1 Poor X-ray image . . . . . . . . . . . . . 44
14.2 Software error . . . . . . . . . . . . . . . . 50
14.3 Fault on the unit . . . . . . . . . . . . . . 51
14.4 Error messages on the touch
screen . . . . . . . . . . . . . . . . . . . . . 53
Appendix
15 Settings menu layout . . . . . . . . . . . . . . 55
16 Scanning times. . . . . . . . . . . . . . . . . . . 58
17 File sizes (uncompressed) . . . . . . . . . . 59
18 Handover protocol . . . . . . . . . . . . . . . . 60
EN

2142100002L02 1908V007 3
– 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
Health Industry Bar Code (HIBC)
Lot designation
CE labelling
CE labelling with the number of the noti-
fied body
Manufacturer
Dispose of correctly in accordance with
EU Directive 2012/19/EU (WEEE).
Refer to the accompanying electronic
documents.
Please read all of the accompanying doc-
uments.
Refer to Operating Instructions.
Wear protective gloves.
Disconnect all power from the unit.
Do not reuse
DC current
1 About this document
These installation and operating instructions
represent part of the unit.
If the instructions and information in
these installation and operating instruc-
tions are not followed, Dürr Dental will
not be able to offer any warranty or as-
sume any liability 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 the follow-
ing VistaScan Mini View units:
Item number:
– 2142-000-80
– 2142-000-80L
– 2142-000-81
– 2142-000-82
– 2142-000-83
– 2142-000-80E
– 2142-000-81E
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:
Description of the type and source of
danger
Here you will find the possible conse-
quences of ignoring the warning
iFollow 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
Important information
EN

4 2142100002L02 1908V007
Important information
2 Safety
Dürr Dental has designed and constructed this
unit so that when used properly and for the in-
tended 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 View
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
therefore against accidental erasure
– to protect against cross-contamination
Bite protector
The bite protector protects the image plate
against mechanical damage.
2.2 Intended use
VistaScan Mini View
The unit may only be operated using accesso-
ries and optional articles manufactured by or
branded with Dürr Dental.
The unit may only be cleaned using the disin-
fectants 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 im-
age plates manufactured by or branded with
DürrDental.
This way up / store and transport in an
upright position
Keep dry
nStacking 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
Dental.
EN

2142100002L02 1908V007 5
Important information
2.5 Specialist personnel
Operation
Unit operating personnel must ensure safe and
correct handling based on their training and
knowledge.
iInstruct or have every user instructed in han-
dling the unit.
Installation and repairs
iInstallation, readjustments, alterations, up-
grades 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
iComply with all the relevant electrical safety
regulations when working on the unit.
iNever touch the patient and unshielded plug
connections on the device at the same time.
iReplace any damaged cables or plugs imme-
diately.
Observe the EMC rules concerning medical
devices
iThe unit is intended for use in professional
healthcare facilities (in accordance with IEC
60601-1-2). If the appliance is operated in an-
other environment, potential effects on elec-
tromagnetic compatibility must be taken into
account.
iDo not operate the unit in the vicinity of HF
surgical instruments or MRT equipment.
iMaintain a minimum distance of at least 30
cm between the unit and other electronic de-
vices.
iNote that cable lengths and cable extensions
have effects on electromagnetic compatibility.
iNo maintenance measures are required to
maintain the EMV basic safety.
NOTICE
Negative effects on the EMC due to
non-authorised accessories
iUse only Dürr Dental parts or acces-
sories specifically approved by Dürr
Dental.
iUsing any other accessories may re-
sult in increased electromagnetic in-
terference emissions or the unit hav-
ing reduced electromagnetic immuni-
ty, leading to an erroneous operation
mode.
Bite protector
The bite protector is a disposable item.
The bite protector is intended solely for use with
DürrDental image plates and DürrDental light
protection covers in dental applications.
2.3 Improper use
Any other usage or usage beyond this scope is
deemed to be improper. The manufacturer ac-
cepts no liability for damages resulting from im-
proper usage . The user bears the sole risks.
VistaScan Mini View
This unit is not suitable for monitoring patients
over longer periods of time.
This unit must not be operated in operating the-
atres or similar rooms, in which dangers may
arise from the combustion of flammable materi-
als.
The touch screen only shows a preview, which
provides an initial impression of the X-ray image.
For purposes of diagnosis the X-ray image must
be viewed on a diagnostic monitor. The preview
of the X-ray image on the touch screen is not
suitable for the purposes of diagnosis.
Light protection covers
Especially: The multiple use of this accessory
and reprocessing contrary to the insturctions of
the manufacturer.
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
iAlways 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.
iCheck the function and condition of the unit
prior to every use.
iDo not convert or modify the unit.
iComply with the specifications of the Installa-
tion and Operating Instructions.
iThe Installation and Operating Instructions
must be accessible to all operators of the unit
at all times.
EN

6 2142100002L02 1908V007
Important information
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 cable) can have a negative
effect in terms of electrical safety and
EMC.
2.10 Transport
The original packaging provides optimum pro-
tection 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 un-
der guarantee.
iOnly transport the unit in its original packag-
ing.
iKeep the packing materials out of the reach of
children.
iDo not expose the unit to any strong vibra-
tions or shocks.
2.11 Disposal
An overview of the waste keys for Dürr
Dental products can be found in the
download area at www.duerrdental.com
(document no. 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).
iIf you have any questions about the correct
disposal of parts, please contact your dental
trade supplier.
Image plate
The image plate contains barium compounds.
iDispose of the image plate properly in accord-
ance with the locally applicable regulations.
iIn Europe, dispose of the image plate in ac-
cordance with waste code 090199 "Wastes
not otherwise specified". Disposal as domes-
tic waste is possible.
NOTICE
Erroneous operation mode due to
use immediately adjacent to other
devices or with other stacked de-
vices
iDo not stack the unit together with
other devices.
iIf this is unavoidable, the unit and oth-
er devices should be monitored in or-
der to ensure that they are working
correctly.
NOTICE
Reduced performance character-
istics due to insufficient distance
between unit and portable HF com-
munication devices
iKeep a distance of at least 30 cm be-
tween 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
antennas).
2.7 Essential performance charac-
teristics
The VistaScan Mini View unit does not possess
any significant performance characteristics as
set out in EN/IEC 60601-1 section 4.3.
The unit complies with the requirements accord-
ing to IEC60601-1-2:2014.
2.8 Notification requirement of seri-
ous incidents
The user / patient is required to report to the
manufacturer and the competent authority of
the Member State, in which the user and/or pa-
tient is established, any serious incident that has
occurred in relation to the device.
2.9 Only use original parts
iOnly use Dürr Dental parts or accessories and
special accessories specifically approved by
Dürr Dental.
iOnly use only original wear parts and replace-
ment parts.
EN

2142100002L02 1908V007 7
Important information
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.
iUse antivirus software and update it regularly.
Look for evidence of possible virus infection
and, if applicable, check with the antivirus
software and remove the virus.
iPerform regular data backups.
iRestrict access to units to trustworthy users,
e.g. via a user name and password.
iMake sure that only trustworthy content is
downloaded. Only install software and
firmware updates that have been authenticat-
ed by the manufacturer.
EN

8 2142100002L02 1908V007
3 Overview
1
3
4
5
9
2
6
7
10
11
8
Product description
EN

2142100002L02 1908V007 9
Product description
1 VistaScan Mini View image plate scanner
2 Stylus
3 Image plate intraoral
4 Light protection cover intraoral
5 Storage box
6 SDHC memory card (fitted in the unit)
7 DBSWIN imaging software DVD
8 VistaSoft imaging software DVD
9 Power supply unit with country-specific adapter
10 Network cable
11 WLAN stick
EN

10 2142100002L02 1908V007
Product description
Light protection covers
– Light Protection Cover Plus, size 0
– Light Protection Cover Plus, size 1
– Light Protection Cover Plus, size 2
– Light Protection Cover Plus, size 3
– Light Protection Cover Plus, size 4
– Light Protection Cover Plus, size 0, white
– Light Protection Cover Plus, size 2, white
3.3 Optional items
The following optional items can be used with
the unit:
Wall bracket . . . . . . . . . . . . . . . . . 2141-001-00
Storage box . . . . . . . . . . . . . . . . . 2141-002-00
Protection cover . . . . . . . . . . . . . . 2141-003-01
Stylus . . . . . . . . . . . . . . . . . . . . . . 9000-623-02
Bite protector, size 4 (100 pcs) . . . 2130-074-03
Image plate and film holder system set
2130100015
Image plate and film holder system
conversion set for endo-exposures 2130100014
Copper dot set, self-adhesive . . . . 2130-006-00
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 350 Classic
disinfection wipes . . . . . . . . . . . CDF35CA0140
FD 333
rapid surface disinfection . . . . . CDF333C6150
FD 322
rapid surface disinfection . . . . . CDF322C6150
FD 366 sensitive rapid surface disin-
fection . . . . . . . . . . . . . . . . . . . CDF366C6150
3.1 Scope of delivery
VistaScan Mini View
image plate scanner . . . . . . . . . . . . . 2142-01
VistaScan Mini View
image plate scanner . . . . . . . . . . . . . 2142-05
VistaScan Mini View
image plate scanner . . . . . . . . . . . . . 2142-07
VistaScan Mini View
image plate scanner . . . . . . . . . . . . . 2142-08
VistaScan Mini View
image plate scanner . . . . . . . . . . . . . 2142-71
– VistaScan Mini View basic unit
– Power supply unit
– Network cable
– SDHC memory card
– Stylus
– VistaSoft imaging software DVD
– DBSWIN imaging software DVD
– WLAN stick (already installed depending on
version)
– Image plates:
- Size 0
- Size 2
– Light protection covers Plus:
- Size 0
- Size 2
– Storage box
– Protection cover
– Image plate cleaning wipes
– Installation and operating instructions
– Quick start instructions
The following items are included in the scope of
delivery (possible variations due to country-spe-
cific requirements and/or import regulations):
3.2 Accessories
The following items are required for operation of
the device, depending on the application:
SDHC memory card . . . . . . . . . . . 9000-134-18
Image plates
– Image Plate Plus, size 0
– Image Plate Plus, size 1
– Image Plate Plus, size 2
– Image Plate Plus, size 3
– Image Plate Plus, size 4
EN

2142100002L02 1908V007 11
Product description
Light protection covers
Light Protection Cover Plus size 0
2 x 3 cm (100 pcs.) . . . . . . . . . . . . 2130-080-00
Light Protection Cover Plus size 1
2 x 4 cm (100 pcs.) . . . . . . . . . . . . 2130-081-00
Light Protection Cover Plus size 2
3 x 4 cm (300 pcs.) . . . . . . . . . . . . 2130-082-00
Light Protection Cover Plus size 2
3 x 4 cm (1000 pcs.) . . . . . . . . . . . 2130-082-55
Light Protection Cover Plus size 3
2.7 x 5.4 cm (100 pcs.) . . . . . . . . . 2130-083-00
Light Protection Cover Plus size 4
5.7 x 7.6 cm (100 pcs.) . . . . . . . . . 2130-084-00
Light Protection Cover Plus size 0,
white
2 x 3 cm (100 pcs.) . . . . . . . . . . . . 2130-080-50
Light Protection Cover Plus size 2,
white
3 x 4 cm (300 pcs.) . . . . . . . . . . . . 2130-082-50
3.5 Wear parts and replacement
parts
Image plates
Plus image plate, size 0
2 x 3 cm (2 pcs.) . . . . . . . . . . . . . . 2130-040-50
Plus image plate, size 1
2 x 4 cm (2 pc.) . . . . . . . . . . . . . . . 2130-041-50
Plus image plate, size 2
3 x 4 cm (4 pcs.) . . . . . . . . . . . . . . 2130-042-50
Plus image plate, size 2
3 x 4 cm (12 pcs.) . . . . . . . . . . . . . 2130-042-55
Plus image plate, size 3
2.7 x 5.4 cm (2 pcs.) . . . . . . . . . . . 2130-043-50
Plus image plate, size 4
5.7 x 7.6 cm (1 pc.) . . . . . . . . . . . . 2130-044-50
Plus ID image plate, size 0
2 x 3 cm (2 pcs.) . . . . . . . . . . . . . . 2130-040-60
Plus ID image plate, size 2
3 x 4 cm (4 pcs.) . . . . . . . . . . . . . . 2130-042-60
Information about replacement parts is
available from the portal for authorised
specialist dealers at:
www.duerrdental.net.
EN

12 2142100002L02 1908V007
Product description
4 Technical data
4.1 Image plate scanner
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
Voltage V AC 100 - 240
Frequency Hz 50/60
Protection class II
Type of protection IP20
Output W < 40
Max. current consumption A 0.8
Classification
Medical product class I
Laser class (unit)
In accordance with IEC60825-1 1
Laser source
Laser class
In accordance with IEC60825-1 3B
Wavelength lnm 635
Output mW 10
General technical data
Dimensions (W x H x D) mm 226 x 275 x 243
in 8.9 x 10.8 x 9.6
Weight kg approx. 7
lb approx. 15.4
Duty cycle S2 (in accordance with
IEC60034-1) min 25
Duty cycle S6 (in accordance with
IEC60034-1) % 25
Pixel size (selectable) μm 12.5 - 50
Max. theoretical resolution Line pairs/
mm (Lp/mm) approx. 40
Noise level
Ready to scan dB(A) approx. 37
During scanning dB(A) approx. 55
Network connection
LAN technology Ethernet
Standard IEEE 802.3u
Data rate Mbit/s 100
EN

2142100002L02 1908V007 13
Product description
Network connection
Connector RJ45
Type of connection Auto MDI-X
Cable type ≥ CAT5
WLAN connection
WLAN technology IEEE 802.11b/g
Encryption WPA, WPA2
Memory card
Type SDHC
Maximum memory capacity GB 32
File system FAT32
Performance class Class ≥ 4
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
Ambient conditions during storage and transport
Temperature °C -20 to 60
°F -4 to +140
Relative humidity % 10 - 95
Air pressure hPa 750 - 1060
Height above sea level m < 16000
ft < 52493
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
EN

14 2142100002L02 1908V007
Product description
Electromagnetic compatibility (EMC)
Interference immunity measurements cover
Immunity to interference, high-frequency electromagnet-
ic fields
IEC61000-4-3:2006+A1:2007+A2:2010
3 V/m
80 MHz - 2.7 GHz
80% AM at 1 kHz
Compliant
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 wire-
less 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
voltage grid
IEC61000-4-4:2012
± 2 kV
100 kHz repetition frequency
Compliant
Immunity to interference, line-line
IEC61000-4-5:2005
± 0.5 kV, ± 1 kV
Compliant
EN

2142100002L02 1908V007 15
Product description
Electromagnetic compatibility (EMC)
Interference immunity measurements supply input
Immunity to interference by surges, line-earth
IEC61000-4-5:2005
± 0.5 kV, ± 1 kV, ± 2 kV
Compliant
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
EN

16 2142100002L02 1908V007
Product description
4.2 Image plate
Classification
Medical devices class IIa
Ambient conditions during operation
Temperature °C 18 - 45
°F 64 - 113
Relative humidity % < 80
Ambient conditions during storage and transport
Temperature °C < 33
°F < 91
Relative humidity % < 80
Dimensions of intraoral image plates
Size 0 mm 22 x 35
Size 1 mm 24 x 40
Size 2 mm 31 x 41
Size 3 mm 27 x 54
Size 4 mm 57 x 76
4.3 Light protection cover
Classification
Medical product class I
EN

2142100002L02 1908V007 17
Product description
5 Operation
5.1 Image plate scanner
1
2
3
5
4
6
1 Operating elements
2 Input unit
3 Stylus
4 Release key
5 Collection tray
6 Memory card slot
The image plate scanner is used to read image
data stored on the image plate.
The unit can be used in two different ways: via
the imaging software (e.g. VistaSoft) on a PC or
directly via the touch screen on the unit.
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.
4.4 Type plate
The type plate is located on the rear of the de-
vice.
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 require-
ments.
EN

18 2142100002L02 1908V007
Product description
Connections
The connections are located on the rear of the
unit, underneath the cover.
1
2
6
4
5
3
1 Connection for power supply unit
2 Reset button
3 USB connection (for WLAN stick)
4 Network connection status LEDs
5 Network connection
6 AUX connection for diagnostic units
ScanManager
When the ScanManager is enabled, more than
one X-ray job can be transmitted to the unit
from different computers simultaneously. The
unit manages the X-ray jobs in a waiting list from
which the required X-ray job can be selected
using the touch screen and then executed.
Without ScanManager the unit processes one
image at a time and is blocked until this job has
been completed. During this time no further X-
ray jobs can be transmitted to the unit from oth-
er computers.
ScanManager can be enabled via Set-
tings > System Settings> Operating
Mode.
If a scanning job is started via the imaging soft-
ware, the image is automatically transmitted to
the computer.
If a scanning job is started via the touch screen,
the image is saved to the memory card and
then needs to be transferred to the computer.
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.
Operating elements
1
2
1 Touch screen
2 On / off switch
The touch screen allows the unit to be operated
when it is not connected to a computer. Instruc-
tions can be entered on the touch screen either
with the tip of a finger or the stylus.
The Help button can be used to open a help
page for the relevant screen. The Messages
button can be used to recall current messages.
EN