Durr Dental VistaPano S User manual

EN
1712V015
9000-618-256/02

Operating Instructions
VistaPano S

9000-618-256/02 1712V015 1
Installation
6 Requirements . . . . . . . . . . . . . . . . . . . . 16
6.1 Installation/setup room . . . . . . . . . 16
6.2 Information about electrical con-
nections . . . . . . . . . . . . . . . . . . . . 16
6.3 System requirements . . . . . . . . . . 16
6.4 Monitor . . . . . . . . . . . . . . . . . . . . . 16
7 Installation . . . . . . . . . . . . . . . . . . . . . . 17
7.1 Electrical safety when making
connections . . . . . . . . . . . . . . . . . 17
7.2 Connecting the unit to the mains . . 17
7.3 Combining devices safely . . . . . . . 17
8 Commissioning and first start-up. . . . . 18
8.1 Acceptance test . . . . . . . . . . . . . . 18
8.2 Electrical safety checks . . . . . . . . . 18
8.3 Switch on the unit . . . . . . . . . . . . . 18
8.4 Installing and configuring the unit . 18
Operation
9 Operation . . . . . . . . . . . . . . . . . . . . . . . 20
9.1 Switch on the unit . . . . . . . . . . . . . 20
9.2 Adjusting the imaging software . . . 21
9.3 Setting up the unit . . . . . . . . . . . . . 26
9.4 Positioning the patient . . . . . . . . . . 26
9.5 Taking the X-ray . . . . . . . . . . . . . . 31
9.6 Transmitting and saving the
image . . . . . . . . . . . . . . . . . . . . . . 32
9.7 Restoring the last image . . . . . . . . 33
9.8 EMERGENCY OFF . . . . . . . . . . . . 33
9.9 RETURN run . . . . . . . . . . . . . . . . . 33
10 Cleaning and disinfection. . . . . . . . . . . 34
10.1 Unit surfaces . . . . . . . . . . . . . . . . . 34
10.2 Positioning aids . . . . . . . . . . . . . . . 34
11 Reprocessing . . . . . . . . . . . . . . . . . . . . 35
11.1 Risk analysis and
categorisation . . . . . . . . . . . . . . . . 35
11.2 Reprocessing procedure in
accordance with EN ISO 17664 . . 35
11.3 General information . . . . . . . . . . . . 35
11.4 Preparation at the operating
location . . . . . . . . . . . . . . . . . . . . . 36
EN
Contents
Important information
1 About this document . . . . . . . . . . . . . . . 3
1.1 Warnings and symbols . . . . . . . . . . 3
1.2 Copyright information . . . . . . . . . . . 3
2 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.1 Intended use . . . . . . . . . . . . . . . . . . 4
2.2 Improper use . . . . . . . . . . . . . . . . . 4
2.3 General safety information . . . . . . . . 4
2.4 Radiation protection . . . . . . . . . . . . 4
2.5 Qualified personnel . . . . . . . . . . . . . 4
2.6 Protection from electric shock . . . . . 4
2.7 Only use genuine parts . . . . . . . . . . 5
2.8 Transport . . . . . . . . . . . . . . . . . . . . 5
2.9 Disposal . . . . . . . . . . . . . . . . . . . . . 5
Product description
3 Overview. . . . . . . . . . . . . . . . . . . . . . . . . 6
3.1 Scope of delivery . . . . . . . . . . . . . . 7
3.2 Accessories . . . . . . . . . . . . . . . . . . 7
3.3 Special accessories . . . . . . . . . . . . 7
3.4 Disposable materials . . . . . . . . . . . . 7
4 Technical data . . . . . . . . . . . . . . . . . . . . 8
4.1 X-ray tube performance data . . . . . . 8
4.2 Dimensions . . . . . . . . . . . . . . . . . . 12
4.3 Type plate . . . . . . . . . . . . . . . . . . . 13
4.4 Conformity assessment . . . . . . . . . 13
5 Operation . . . . . . . . . . . . . . . . . . . . . . . 14
5.1 Touch screen . . . . . . . . . . . . . . . . 14
5.2 Exposure button . . . . . . . . . . . . . . 14
5.3 Positioning aids . . . . . . . . . . . . . . . 15
5.4 Manual switch for height
adjustment (optional) . . . . . . . . . . . 15

2 9000-618-256/02 1712V015
Contents
11.5 Manual cleaning, intermediate
rinsing, disinfection, final rinse,
drying . . . . . . . . . . . . . . . . . . . . . . 36
11.6 Automatic cleaning,
intermediate rinsing,
disinfection, final rinse, drying . . . . 37
11.7 Check for function. . . . . . . . . . . . . 37
11.8 Steam sterilising . . . . . . . . . . . . . . 37
11.9 Issue clearance for the parts for
sterilisation . . . . . . . . . . . . . . . . . . 37
11.10 Storing parts for sterilisation . . . . . 38
12 Maintenance. . . . . . . . . . . . . . . . . . . . . 39
12.1 Recommended maintenance
schedule . . . . . . . . . . . . . . . . . . . . 39
Troubleshooting
13 Tips for operators and service techni-
cians. . . . . . . . . . . . . . . . . . . . . . . . . . . 41
13.1 Error messages . . . . . . . . . . . . . . . 41
Appendix
14 Information about EMC in accord-
ance with EN 60601-1-2 . . . . . . . . . . . . 42
14.1 General information . . . . . . . . . . . . 42
14.2 Abbreviations . . . . . . . . . . . . . . . . 42
14.3 Guidelines and manufacturer's in-
formation . . . . . . . . . . . . . . . . . . . 42
14.4 Calculation table . . . . . . . . . . . . . . 46
15 Program parameters . . . . . . . . . . . . . . 47
15.1 Tall, well-built patient, S-Pan . . . . . 47
15.2 Average patient, S-Pan . . . . . . . . . 47
15.3 Small patient, S-Pan . . . . . . . . . . . 48
15.4 Child, S-Pan . . . . . . . . . . . . . . . . . 49
15.5 Child arch, tall, well-built patient . . 49
15.6 Child arch, average patient . . . . . . 50
15.7 Child arch, small patient . . . . . . . . 51
16 Information on scattered radiation. . . . 52
17 Information on the
leakage rate . . . . . . . . . . . . . . . . . . . . . 53
EN

9000-618-256/02 1712V015 3
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.
Comply with the Operating Instructions.
CE labelling with the number of the noti-
fied body
CSA classification
Manufacturer
Date of manufacture
Dispose of correctly in accordance with
EU Directive 2012/19/EU (WEEE).
Application part type B
Do not reuse
EC REP Authorised EU representative
Medical device in accordance with US-
FDA
Wear hand protection.
Switch off and de-energise the unit
(e.g.unplug from mains).
Laser class 1 product
1.2 Copyright information
All names of circuits, processes, names, soft-
ware programs and units used 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.
1 About this document
These installation and operating instructions
form 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.
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
Warning – dangerous high voltage
Warning – X-rays
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
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
– CAUTION
Risk of minor injuries
– NOTICE
Risk of extensive material/property damage
Important information
EN

4 9000-618-256/02 1712V015
Important information
shielding or protective aprons, especially for
children and teenagers.
iThe persons operating the equipment must
keep away from the X-ray unit while the expo-
sure is being taken. The minimum distance re-
quired by law must be maintained (e.g.Ger-
many 1.5m, Austria 2.0m).
iChildren and pregnant women must consult a
doctor before having an X-ray taken.
iNobody else must be in the radiation room
without X-ray protection measures apart from
the patient. In exceptional circumstances an-
other person may be present to provide as-
sistance, but this must not be a member of
the surgery staff. When the exposure is being
taken, make sure that you maintain visual
contact with the patient and the unit and keep
talking to the patient.
iThe radiation room must be lockable to pre-
vent entry by unauthorised persons.
iIf a fault occurs, cancel the exposure immedi-
ately by letting go of the trigger button.
2.5 Qualified personnel
Operation
Persons who operate the units 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 Protection from electric shock
iWhen working on the units observe all the rel-
evant electrical safety regulations.
iNever touch the patient and unshielded plug
connections on the device at the same time.
iImmediately replace any damaged lines and
connections.
Observe the EMC rules concerning medical
devices
iObserve specific precautionary measures re-
lating to electromagnetic compatibility (EMC)
for medical devices, see "14 Information
about EMC in accordance with EN 60601-1-
2".
2 Safety
The unit has been developed and designed in
such a way that dangers are effectively ruled out
if used in accordance with the proper, intended
use. Nevertheless, residual risks can remain.
You should therefore observe the following
notes.
2.1 Intended use
The unit is designed exclusively for taking pano-
ramic X-ray images for the inspection and diag-
nosis of diseases in the oral cavity and craniofa-
cial anatomy.
2.2 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 this.
In these cases the user/operator will bear the
sole risk.
2.3 General safety information
The sale or prescription of this device by a med-
ical practitioner is subject to the restrictions of
the applicable Federal Acts. The device may be
used only under permanent supervision of a
dentist or licensed medical practitioner.
Medical device in accordance with US-
FDA
iWhen operating this device always observe all
guidelines, laws, and other rules and regula-
tions that are applicable at the site of opera-
tion.
iPrior to each use, check condition of the de-
vice and make sure it is in perfect working or-
der.
iDo not convert or modify the units.
iObserve the Installation and Operating In-
structions.
iMake the Installation and Operating Instruc-
tions available to the person operating the de-
vice at all times.
2.4 Radiation protection
iComply with all applicable X-ray protection
rules and take all required X-ray protection
measures.
iUse the prescribed X-ray protection equip-
ment.
iIn order to reduce the level of X-ray exposure,
we recommend the use of bismuth, lead
EN

9000-618-256/02 1712V015 5
Important information
2.7 Only use genuine parts
iOnly use Dürr Dental parts or accessories and
special accessories specifically approved by
Dürr Dental.
iOnly use only genuine working parts and
spare parts.
2.8 Transport
The original packaging provides optimum pro-
tection for the device during transport.
If required, original packaging for the unit can be
ordered from Dürr Dental.
Dürr Dental does not accept any respon-
sibility or liability for damage occurring
during transport due to the use of incor-
rect packaging, even where the unit is
still under guarantee.
iOnly transport the device in its original pack-
aging.
iKeep the packing materials out of the reach of
children.
iReattach the transport locking devices.
iDo not expose the unit to any strong vibra-
tions or shocks.
Do not bump or pull the unit.
2.9 Disposal
Unit
The unit must be properly disposed of.
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.
X-ray emitter
The X-ray unit contains a tube that is potentially
capable of imploding, lead cladding and mineral
oil.
EN

6 9000-618-256/02 1712V015
3 Overview
1
3
2
5
4
6
8
7
9
101113 12
1 Panoramic X-ray unit
2 Small parts
3 DBSWIN imaging software DVD
4 VistaSoft imaging software DVD
5 Test body holder
6 Exposure switch
7 Head support with cushion*
8 Hygienic protective covers for bite block*
9 Bite block*
10 Adapter bite block*
11 Chin holder for maxillary joint image*
12 Chin holder for edentulous jaws*
13 Chin holder for sinus image*
*These are parts that the patient will come into contact with.
Product description
EN

9000-618-256/02 1712V015 7
Product description
Positioning aids
Adapter bite block. . . . . . . . . . . . . 2207-050-50
Bite block piece (3 pieces) . . . . . . 2210200399
Chin holder for toothless . . . . . . . . 2207-052-50
Head supports with cushion . . . . . 2207100009
Cushion for head supports . . . . . . 2207100010
Chin holder for mandibular joint
image . . . . . . . . . . . . . . . . . . . . . . 2207-053-50
Chin holder for sinus image . . . . . . 2207-054-50
3.3 Special accessories
The following optional items can be used with
the device:
Foot . . . . . . . . . . . . . . . . . . . . . . . 2207-100-50
Manual switch for height adjustment
incl. holder . . . . . . . . . . . . . . . . . . 2207-070-50
Screw cover set . . . . . . . . . . . . . . 2207100051
Acceptance and consistency check
Test body set for Pano . . . . . . . . 2121-060-55
Primary absorber set Pano/Ceph . 2207100047
3.4 Disposable materials
The following materials are consumed during
operation of the device and must be ordered
separately:
Hygienic protective cover bite block
(100 pieces) . . . . . . . . . . . . . . . . . 2207-010-50
Cleaning and disinfection
FD 350 Classic disinfection
wipes . . . . . . . . . . . . . . . . . . . . CDF35CA0140
FD 333 rapid surface
disinfectant . . . . . . . . . . . . . . . . CDF333C6150
FD 322 rapid surface
disinfectant . . . . . . . . . . . . . . . . CDF322C6150
FD 366 rapid disinfectant for sensitive
surfaces . . . . . . . . . . . . . . . . . . CDF366C6150
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):
VistaPano S . . . . . . . . . . . . . . . . . . . . 2207-01
– DBSWIN imaging software DVD
– VistaSoft imaging software DVD
– Network cable, 10m
– Exposure switch and holder
– Adapter bite block
– Bite block
– Chin holder for edentulous jaws
– Chin holder for maxillary joint image
– Chin holder for sinus image
– Head support with cushion
– Hygienic protective covers for bite block (100
pieces)
– Test body holder (Germany, Switzerland and
Austria only)
– Small parts
– Screw cover set
– Operating instructions
– Installation instructions
– PCI Express Gigabit Ethernet card
3.2 Accessories
The following articles are necessary for the op-
eration of the unit, depending on the applica-
tion:
Laser test tool . . . . . . . . . . . . . . . . 2207-020-50
Ball phantom . . . . . . . . . . . . . . . . 2207-021-50
Hygienic protective cover bite block
(100 pieces) . . . . . . . . . . . . . . . . . 2207-010-50
Test body holder for VistaPano S (can
be used with test body set for Pano
2121-060-55 and with test body
2121-060-54) . . . . . . . . . . . . . . . . 2207-900-50
Adapter cable for remote exposure
button . . . . . . . . . . . . . . . . . . . . . . 2207-070-51
Activation of the DBSWIN X-ray mod-
ule . . . . . . . . . . . . . . . . . . . . . .2100-725-04FC
EN

8 9000-618-256/02 1712V015
Product description
4 Technical data
Electrical data for the unit
Nominal voltage V AC 200-240
Max. mains voltage fluctuation % ±10
Frequency Hz 50/60
Rated power W 170
Maximum power kVA 2.2
Classification
Medical product class IIb
Manufacturer: VATECH Co., Ltd. for Dürr Dental
13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggi-do,
Korea
Authorised EU representative
Vatech Dental Manufacturing Ltd., Suite 3, Ground
Floor, Chancery House, St. Nicholas Way, Sutton,
SM1 1JB UK
Product Digital X-ray system
Model VistaPano
X-ray emitter
Model DG-07C11T2 (H)
Rated power kW 1.6 (at 1 sec)
Type: high-voltage generator Inverter
Nominal voltage, high-voltage generator kV 50 - 99 (±10%)
Nominal current, high-voltage generator mA 4-16 (for 1 kVp)
Cooling, high-voltage generator Automatic monitoring
Shut-off at ≥ 60°C
Additional filtering at 50 kV mmAl 2.0
Integrated filtering at 50 kV mmAl 0.8
Total filtering at 50 kV mmAl 2.8
X-ray tube model Toshiba D-052SB
Focal spot size as per IEC 60336 X-ray tube mm 0.5
Anode angle ° 5
Pulse/pause ratio 1:60 or more
Duration of radiation exposure sec. 1.9 - 13.5
4.1 X-ray tube performance data
– Maximum deviation of the voltage peak from the displayed value ± 10%
– Maximum deviation of the tube current from the displayed value ± 20%
– Maximum deviation of the exposure time from the displayed value ± 10%
– The device complies with the standards IEC 61223-3-4 and IEC 60601-1.
– The lowest possible stress factor is obtained with a combination of the settings 50kV and 4mA.
EN

9000-618-256/02 1712V015 9
Product description
1 2 3 5
5
7 10
10
20
25
15
20
EXPOSURE TIME [s]
Constant potential high-voltage generator
Nominal Focus Spot Value: 0.5
TUBE CURRENT [mA]
100kV
90kV
80kV 70kV 60kV
50kV
Maximum Rating Charts
DC (Center Grounded)
1
2
3
4
5
6
5
10
20
25
15
0
2.9 3.0 3.1 3.2 3.3 3.4 3.5
Constant potential high-voltage generator
Nominal Focus Spot Value: 0.5
TUBE CURRENT [mA]
100kV
Ef
80kV
50kV
FILAMENT CURRENT [A]
FILAMENT VOLTAGE [V]
Emission and Filament Characteristics
EN

10 9000-618-256/02 1712V015
Product description
0
0
5
10
20
30
15
25
35
2 4 6 8 10
175 W
225 W
315 W
TIME (min)
COOLING
HEATING
HEAT STORAGE (kJ)
Anode Thermal Characteristics
TIME (min)
HEAT STORAGE (kJ)
Monoblock Cooling Curve
0
100
200
400
600
300
500
1 151 301 466 631
Detector
Brand Xmaru 1501CF-HS
Type CMOS photodiode array
Pixel size μm 100
Active surface area mm 6 x 150.4
Frame rate fps 300
Greyscale bit 14
General technical data
Height mm 1580 - 2280
Dimensions (W x D) mm 990 x 1130
Vertical radius mm 700
Weight
Weight with foot (optional)
kg
kg
100
148
EN

9000-618-256/02 1712V015 11
Product description
Acquisition
mode
FDD
mm
FOD
mm
ODD
mm
Image capture scale
(magnification factor)
Panoramic 490.2 375.0 115.2 1.3
FDD: distance from focal spot to detector
FOD: distance from focal spot to object
ODD: distance from object to detector (ODD = FDD - FOD)
Image capture scale = FDD/FOD
Ambient conditions during operation
Temperature °C 10 - 35
Relative humidity % 30 - 75
Air pressure hPa 860 - 1060
Ambient conditions during storage and transport
Temperature °C -10 to +60
Relative humidity % 10 - 75
Air pressure hPa 860 - 1060
EN

12 9000-618-256/02 1712V015
Product description
4.2 Dimensions
1580 Min 400~Max 700
2280
1252
1220 ~ 1300
990
EN

9000-618-256/02 1712V015 13
Product description
4.3 Type plate
The type plates are located on the X-ray emitter
and on the telescopic column.
4.4 Conformity assessment
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.
The VistaPano S has been developed and man-
ufactured in accordance with the following regu-
lations:
– Installation of X-ray units: [DG-10A05T3] IEC
60601-2-28 (1993)
– Protection against water penetration: Not
protected: IPX0
– Protection against electric shock: Protection
class I device, Type B application part
The CE mark declares that the product satisfies
the applicable requirements according to Direc-
tive 93/42/EU for medical products.
EN

14 9000-618-256/02 1712V015
Product description
5.1 Touch screen
1 2 3 4
1 Activate/deactivate all positioning beams
2 Test circulation, keep the button pressed
3 Return
4 Display language
5.2 Exposure button
Exposure switch
The exposure switch is used to trigger the pre-
pared image acquisition and start the X-ray ex-
posure. The LED indicates the unit status, as
does the LED on the unit.
– Green: The unit is ready
– Yellow: X-radiation active
1
2
1 Indicator lamp (LED)
2 Exposure button
Alternative exposure button (optional)
This exposure button is usually mounted out-
side the X-ray room. The exposure button is
used to trigger the prepared image acquisition
and start the X-ray exposure.
5 Operation
6
5
7
8
9
10
3
4
12
1 EMERGENCY OFF button
2 On/off switch
3 X-ray tube
4 C-shaped angle connector piece
5 Status LED
6 Head supports
7 Chin holder and bite block
8 Lever for adjustment of the upper canine
positioning beam
9 Setting wheel for adjustment of the head
supports
10 Buttons for height adjustment
The panoramic X-ray unit is used to take digital
panoramic images that enable diagnostics in the
oral area.
The X-ray job is started via the imaging software
and activated via the touch screen.
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9000-618-256/02 1712V015 15
Product description
5.4 Manual switch for height
adjustment (optional)
The manual switch can be used as an alterna-
tive to the buttons on the touch screen for the
height adjustment of the unit.
5.3 Positioning aids
The positioning aids are used to correctly posi-
tion the patient in the unit. The suitable position-
ing aid is selected according to the selected im-
age. The head supports gently keep the head of
the patient in place.
Bite block and adapter bite
block
Chin holder for edentulous
jaws
Chin holder for maxillary joint
image
Chin holder for sinus image
Head support with cushion
EN

16 9000-618-256/02 1712V015
6.3 System requirements
The system requirements for the compu-
ter systems can be found in the down-
load area at www.duerrdental.com (doc-
ument no. 9000-618-148).
6.4 Monitor
The monitor must comply with the requirements
for digital X-ray with a high light intensity and
wide contrast range.
Strong ambient light, sunlight falling directly onto
the monitor and reflections can make it harder
or even impossible to perform a diagnosis
based on the X-ray images.
Only qualified specialists or employees
trained by Dürr Dental are permitted to
install, connect and start using the unit.
6 Requirements
6.1 Installation/setup room
The room chosen for set up should fulfil the fol-
lowing requirements:
– Closed, dry room.
– Should not be a room made for another pur-
pose (e.g. boilerroom or wet cell).
– There should be no large fields of interference
(e.g.strong magnetic fields) present that can
interfere with the correct operation of the unit.
– The required environmental conditions are
satisfied (refer to the "Technical Data" in the
operating instructions).
6.2 Information about electrical
connections
iEnsure that the electrical connections to the
mains power supply are established in ac-
cordance with current valid national and local
regulations and standards governing the in-
stallation of low voltage units in medical facili-
ties.
iObserve the current consumption of the de-
vices that are to be connected.
The diameter of the connections depends on
the current consumption, length of line and the
ambient temperature of the unit. Information
concerning the current consumption can be
found in the Technical Data supplied with the
particular unit to be connected.
The following table lists the minimum diameters
of the connections in relation to the current con-
sumption:
Current consumption of
unit [A]
Cross-section
[mm2]
> 10 and < 16 1.5
> 16 and < 25 2.5
> 25 and < 32 4
> 32 and < 40 6
> 40 and < 50 10
> 50 and < 63 16
Installation
EN

9000-618-256/02 1712V015 17
Installation
A copy of the system manufacturer‘s
declaration in accordance with Article 12
of Directive 93/42/EEC can be found in
our download section at www.duerrden-
tal.com (document no. 9000-461-264).
7 Installation
7.1 Electrical safety when making
connections
iMake sure that none of the electrical cables
leading to the unit are under any mechanical
tension.
iBefore initial start-up check that the mains
supply voltage and the voltage stated on the
type plate match (see also "4. Technical
data").
iConnect the unit and the computer to a
shared protective earth.
7.2 Connecting the unit to the
mains
Requirements:
– Mains voltage must match the information
shown on the type plate of the power supply
unit.
iConnect up the lines.
7.3 Combining devices safely
Take care when connecting units together or to
parts of other systems as there is always an ele-
ment of risk (e.g. due to leakage currents).
iOnly connect units when there can be no
question of danger to operator or to patient.
iOnly connect units when it is safe to do so
and there is no risk of damage or harm to the
surroundings.
iIf it is not 100% clear from the unit data sheet
that such connections can be safely made or
if you are in any doubt, always get a suitably
qualified person (e.g. the manufacturer) to ver-
ify that the setup is safe.
iWhen connecting the unit to other
devices,such asa PC system,comply with the
requirements set out in section16 of
IEC60601-1 (EN60601-1).
iWhen setting up the PC system in the vicinity
of the patients:
Only connect components (e.g. computer,
monitor, printer) that comply with the standard
IEC60601-1 (EN60601-1).
iWhen setting up the PC system outside of the
vicinity of the patients:
Connect components (e.g. computer, monitor,
printer) that comply at least with the standard
IEC60950-1 (EN60950-1) at least.
EN

18 9000-618-256/02 1712V015
Installation
8.2 Electrical safety checks
iCarry out the electrical safety check according
to the national law (e.g. in accordance with
IEC 62353).
iDocument the results.
8.3 Switch on the unit
CAUTION
Danger of injury due to movement of
the the C-shaped angle connector
piece
After switching on the unit and confirm-
ing the parameters on the touch screen,
the C-shaped angle connector piece is
positioned. Persons can be injured dur-
ing this.
iNobody must remain in the area of
the C-shaped angle connector piece
while the unit is being switched on.
iSwitch on the device.
The LED on the unit flashes blue during the
start-up process. Once the unit is ready for
operation the LED on the unit lights up blue.
8.4 Installing and configuring the
unit
The unit supports the following imaging pro-
grams:
– VistaSoft from Dürr Dental
– VistaConnect from Dürr Dental
– DBSWIN from Dürr Dental
– VistaEasy from Dürr Dental
– ImageBridge from Dürr Dental
– Third-party software on request
8 Commissioning and first
start-up
NOTICE
Short circuit due to the build up of
condensation
iDo not switch on the unit until it has
warmed up to room temperature and
it is dry.
The required tests (e.g.acceptance tests) must
be carried out in accordance with local rules
and regulations.
iFind out which tests are required.
iCarry out testing in accordance with local
rules and regulations.
8.1 Acceptance test
The Intra/Extra Digital test body is re-
quired for performing acceptance tests
for panoramic systems, together with the
appropriate test body holder if necessary.
iBefore the unit is started up and used for the
first time, the acceptance test of the X-ray
system must be carried out in accordance
with national regulations.
Inserting the test body holder
The test body is used on the test body holder
for the acceptance test and consistency test.
iInsert the test body holder.
EN