Durr Dental VistaCam Digital User manual

EN
9000-618-88/30

2013/08
Dürr Dental VistaCam Digital
with pressure sensitive release
Installation and Operating Instructions

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2 2013/08

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Content
Important information
1. General . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.1 Conformity Acceptance Procedure . . 4
1.2 General Notes . . . . . . . . . . . . . . . . . 4
1.3 Appliance Disposal . . . . . . . . . . . . . . 4
1.4 Notes concerning Medical
Appliances MPG . . . . . . . . . . . . . . . . 4
1.5 Correct Usage . . . . . . . . . . . . . . . . . 5
1.6 Incorrect Usage . . . . . . . . . . . . . . . . 5
1.7 Using Peripheral Devices . . . . . . . . . 5
2. Safety . . . . . . . . . . . . . . . . . . . . . . . . . . 5
2.1 General Safety Notes . . . . . . . . . . . . 5
2.2 Electrical Safety Notes . . . . . . . . . . . 5
3. Warning and Symbols . . . . . . . . . . . . . 6
3.1 Model identification plate . . . . . . . . . 6
4. Delivery Contents . . . . . . . . . . . . . . . . . 7
4.1 Special accessories . . . . . . . . . . . . . 7
4.2 Disposable materials . . . . . . . . . . . . 7
5. Technical Data . . . . . . . . . . . . . . . . . . . 7
6. Functional Diagram . . . . . . . . . . . . . . . 8
7. Functional Description . . . . . . . . . . . . . 8
Installation
8. Set-up . . . . . . . . . . . . . . . . . . . . . . . . . . 9
8.1 Room for Set-up . . . . . . . . . . . . . . . 9
8.2 Attaching the handpiece holder . . . . 9
9. Electrical Connection and
Commissioning . . . . . . . . . . . . . . . . . . 10
Use of the Appliance
10. Operation . . . . . . . . . . . . . . . . . . . . . . . 11
10.1 IFC Optic . . . . . . . . . . . . . . . . . . . 11
10.2 Switch on the VistaCam Digital . . . 12
10.3 Recording images: Live / Freeze
modes . . . . . . . . . . . . . . . . . . . . . 12
10.4 Switch off the VistaCam Digital . . . 13
10.5 Using hygienic protective covers . . 14
11. Disinfection and Cleaning . . . . . . . . . . 15
11.1 Cleaning the optical window . . . . . 15
11.2 Cleaning and disinfecting
handpiece and other accessories . 15
12. Maintenance . . . . . . . . . . . . . . . . . . . . 15
Trouble-shooting
13. Tips for Operators and Service
Technician . . . . . . . . . . . . . . . . . . . . . . 16

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1. General
1.1 Conformity Acceptance
Procedure
• This product has, in accordance with the
European Union directive
93/42/EWG, been checked for conformity and
has been found to fulfill all the requirements of
these regulations.
1.2 General Notes
• These Installation and Operating Instructions
form an integral part of the unit. They must be
kept close to the unit at all times. Precise ob-
servance of these instructions is a precondi-
tion for use of the unit for the intended purpo-
se and for its correct operation.
New personnel must be made aware of the
contents, and they should be passed on to fu-
ture operating staff.
• Safety for the operators as well as trouble-free
operation of this appliance can only be gua-
ranteed where original parts (OEM)have been
used. In addition, only those accessories may
be used which are specifically mentioned in
the Installation and Operating Instructions or
have been authorised by Dürr Dental. Where
other accessories are used, Dürr Dental can
accept no responsibility concerning operation
or safe functioning of the equipment. All
claims concerning injury or damage where
non-original parts are used will not be
accepted.
• Dürr Dental are only responsible for the equip-
ment with regard to safety, reliability and pro-
per functioning where assembly, resettings,
changes or modifications, extensions and re-
pairs have been carried out by Dürr Dental or
an agency authorized by Dürr Dental and if
the equipment is used in conformity with the
Installation and Operating Instructions.
• These Installation and Operating Instructions
conform to the relevant version of the equip-
ment and the underlying safety standards va-
lid at the time of going to press. All circuits ,
processes, trade marks, software programs
and appliances named in this document are
registered names.
• The translation of these Installation and
Operating Instructions has been carried out in
good faith. Dürr Dental accepts no liability for
mistakes in the translation - contact your sup-
plier if in doubt about any points. The enclo-
sed German version of these Installation and
Operating Instructions is the reference
version.
• Any reprinting of the technical documentation,
in whole or in part, is subject to prior approval
of Dürr Dental being given in writing.
• Retain the packaging for possible return of the
product to the manufacturers. Ensure that the
packaging is kept out of the reach of children.
Only the original packaging provides adequate
protection during transport of the unit.
Should return of the product to the manufac-
turers be necessary during the guarantee peri-
od, Dürr Dental accepts no responsibility for
damage occurring during transport where the
original packaging was not used!
1.3 Appliance Disposal
• The EU-directive 2002/96/EG - WEEE (Waste
Electric and Electronic Equipment) of 27th
January 2003 and the current version as ad-
opted by national law states that dental pro-
ducts are covered by this above directive and,
within the European Union, must be disposed
of according to special waste disposal proce-
dures.
Should you have any questions concerning
the correct disposal of one of our products
then please contact Dürr Dental or your spe-
cialist dental dealer, who will be pleased to
help.
1.4 Notes concerning Medical
Appliances MPG
• This product is a technical medical appliance
and, as such, may only be operated by
trained personnel, or persons who, as a result
of specialist knowledge, are familiar with this
type of appliance.
Important
information

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1.5 Correct Usage
• The VistaCam Digital has been designed and
constructed solely for taking intraoral and ex-
traoral images in the dental medical surgery or
clinic.
1.6 Incorrect Usage
• Any use of this appliance/these appliances
above and beyond that laid down in the
Installation and Operating Instructions is dee-
med to be incorrect usage. The manufacturer
cannot be held liable for any damage resulting
from incorrect usage. The operator will be held
liable and bears all risks.
1.7 Using Peripheral Devices
Peripheral appliances (computer, monitor,
printer) may only be connected to this
unit where they fulfill all the requirements
of standard IEC 60950-1 (EN 60950-1).
The PC-unit must be located away from
the patient treatment area (1.5m from the
patient). Where this is not possible then
the complete computer set up must be
operated and installed according to stan-
dards IEC 60601-1-1 (EN 60601-1-1).
2. Safety
2.1 General Safety Notes
This appliance has been designed and
constructed by Dürr Dental so that correct usage
of the appliance is virtually free of any possible in-
jury or danger. In spite of this, we feel it is our
duty to mention the following safety measures in
order to prevent any possible danger.
• When using this appliance all local and relevant
regulations must be observed!
Converting or modifying the appliance in any
way is strictly prohibited. In such cases, any
and all guarantees immediately become invalid.
The operation of modified appliances can be
punishable by law. In the interests of trouble-
free operation the operator is responsible for
observing these regulations.
• Before every use the operator must check the
functional safety and the condition of the
appliance.
• The operator must be knowledgeable in the
operation of the appliance.
• The product is not designed to be used in
medical treatment areas where there exists
the danger of explosion. Areas where explosi-
ons could occur are those where flammable
anesthetic material, skin cleansers, oxygen
and skin disinfectants are present. This appli-
ance is not to be used in areas where the at-
mosphere could cause fire.
2.2 Electrical Safety Notes
• The appliance may only be operated from a
power socket that has been correctly installed
according to national regulations.
• Do not plug into any multi-socket unit or any
socket that may be altered locally. The usage
of such socket sets could lead to the rated
value of the leakage current being exceeded.
• Before connecting the appliance check that
the supply voltage and the supply frequency
of the equipment and the local supply are
compatible.
• Check the appliance and the power supply
cables for possible damage before switching
on. Damaged cables, plugs and sockets must
be replaced before use.
• Never touch open supply outlets and patients
simultaneously.
• When working with this appliance observe all
national and local electrical safety regulations.

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3. Warning and Symbols
The Installation and Operating Instructions uses
the following signs and symbols for especially
important notes:
Information and/or mandatory re-
gulations or prohibitions for the
prevention of personal injury or
substantial property damage
Special information regarding the eco-
nomical use of the equipment and other
information
Only to be used once
Symbols on the VistaCam Digital
Macro
Intraoral
Extraoral
3.1 Model identification plate
The model identification plate can be found to
the side by the USB-connector.
The following abbreviations are included on the
model identification plate:
CE-labeling
Please observe instructions in accom-
panying documentation
Dispose of correctly according to EU-
directive (2002/96/EG - WEEE)
REF Order Number
SN Serial number
REF: 2106-120-56
SN: T000XXX

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4. Delivery Contents
Installation and
Operating Instructions . . . . . . . 9000-618-88/xx
Handpiece . . . . . . . . . . . . . . . . . . 2106-120-56
Hygienic protective covers
20 pieces . . . . . . . . . . . . . . . . . . . 2103-010-51
USB Y-adaptor . . . . . . . . . . . . . . . 2106-150-72
Optics cleaning set . . . . . . . . . . . . 2106-105-50
4.1 Special accessories
The following parts are not
supplied with the contents of delivery.
Please order as required!
Extension connection cable (2m) . . 2106-151-55
DBSWIN Image Editor . . . . . . . .2100-725-03FC
4.2 Disposable materials
Hygieneic protective covers,
500 pieces . . . . . . . . . . . . . . . . . . 2106-010-50
Cleaning set for Optic . . . . . . . . . . 2101-025-50
FD 350 Disinfectant wipes . . . . . CDF350CO140
5. Technical Data
Electrical Values and Connections
Voltage (V) . . . . . . . . . . . . . . . . . . . . . 100-240
Frequency (Hz) . . . . . . . . . . . . . . . . . . . . 50-60
Signal output . . . . . . . . . . . . . . . . . . . USB 2.0
Dimensions and weight (handpiece)
Length (mm) . . . . . . . . . . . . . . . . . . . . . . . . 207
Diameter (mm) . . . . . . . . . . . . . . . . . max. 27.5
Weight including cable (g) . . . . . . . . . . . ca. 200
Weight without cable (g) . . . . . . . . . . . . . ca. 66
Camera cable (cm) . . . . . . . . . . . . . . . . . . . 300
Lighting
6 LEDs with light concentrating lens
System features
Colour system . . . . . . . . . . . . . . . . . . . . . . . PAL
Automatic brightness control
White balance factory set to (K) . . . . . . . . . 3400
Temperature ranges
Appliance in operation (°C) . . . . . . . +10 to +40
Storage and transport (°C) . . . . . . . . -15 to +60
Relative Humidity
Appliance in operation (%) . . . . . . . .20 - max.75
Storage and Transport (%) . . . . . . . . . . max. 90
Ambient air pressure
Appliance in operation (hPa) . . . . . . . 700-1060
Storage and transport (C) . . . . . . . 700 to -1060
Camera electronics
Image sensor . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . 1/4" Color Interline Transfer CCD
Pixels PAL . . . . . . . . . . . . . . . . . . . . . . . 470000
Pixels effective (PC)
YUV . . . . . . . . . . . 720 horizontal x 576 vertical
Fuse type
IP20
Protection class
II, User application Type BF

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6. Functional Diagram
7. Functional Description
The VistaCam Digital consists of a handpiece (1)
with an IFC optical component (Iris Focus
Control), a USB Y-adaptor and a handpiece
holder.
The handpiece is connected directly to the PC
using both connectors on the USB Y-adaptor (5).
The handpiece is switched on automatically as
soon as it is removed from the handpiece holder
(2).
The handpiece (1) is equipped with 6 white
LEDs, which provide sufficient light for operati-
on. The special IFC-Optic allows macro, intrao-
ral and extraoral images to be prepared. Within
the macro and intraoral ranges the IFC Optic
provides a high depth of field. In the extraoral
range the IFC Optic has a high light intensity.
The image is obtained by the IFC Optic and
then digitalised by the electronics within the
handpiece unit. Finally the prepared image data
is transmitted via the USB 2.0 -connection di-
rectly to the PC (4).
By operating the pressure sensitive release on
the handpiece (6) images on the monitor can be
switched from Live Mode to Freeze Mode (free-
ze frame), saved or erased (depending on the
software used).
The the pressure sensitive release functions
using a pressure sensitive ring, which operates
regardless of the actual angle of the camera and
which activates on a short pressing with one´s
fingers.
2
(1) Handpiece
(2) Handpiece holder
(4) PC
(5) USB Y-adaptor
(6) Manual operating switch
6
1
4
5

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1
2
8. Set-up
Danger of short circuit:
Do not set VistaCam Digital up in
the vicinity of washbasins or the
spittoon. Spray or water drop-
lets must not be allowed to enter
the camera or on the electrical
connections.
8.1 Room for Set-up
The room temperature must not fall below
+ 10 °C in winter and in summer must not rise
above + 40 °C.
8.2 Attaching the handpiece holder
The handpiece holder (2) can be set up at any
desired position near the VistaCam Digital
(length of USB cable is 2,90 m). Refer to instal-
lation instructions order number 2105-105-00.
Damage to the VistaCam Digital:
The handpiece can fall out of the
handpiece holder if this is set up
incorrectly or not carefully.
Position the handpiece holder so
that the handpiece can not possibly
fall out.
Installation

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9. Electrical Connection
and Commissioning
See also the enclosed instructions "Installation
and configuration of VistaCam Digital" order
number 9000-618-89/01
See also section 1.7 usage of peripheral appli-
ances .
Danger of short circuit due to
condensation.
This system should not be operated
until it has warmed up to room tem-
perature and is completely dry.
• Insert the handpiece (1) into the handpiece
holder (2).
• Switch on the PC and place the driver-CD
supplied into the CD/DVD-drive.
• Open the file "VCDsetup.exe" and follow the
instructions in the Setup menu.
• Restart the PC and install the image editing
software, e.g. DBSWIN.
Example using image editing software
DBSWIN
• Start DBSWIN and select a patient.
• Take the handpiece (1) out of its handpiece
holder (2). The camera will automatically
switch on.
• Select Video-module.
• The live image is now displayed on the
monitor.
The camera automatically switches off
after 10 minutes continuous operation.
Use the image editing software and the
Live/Freeze Button to continue operati-
on with the camera.
Testing according to IEC 60601-1
After commissioning or first use of the VistaCam
Digital then the tests according to IEC 60601-1
must be carried out and documented, e.g. pati-
ent conductivity etc.
2
2
1
3
1
2

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10. Operation
Damage to the handpiece:
The handpiece can easily be dama-
ged if dropped or allowed to fall on
the floor. Do not rest the handpiece
on a working surface, always place
it securely back in the handpiece
holder supplied.
The optical lens can be damaged
if it comes into contact with sharp
metal objects or similar. Do not
place the handpiece between surgi-
cal instruments.
The quality of the image can be
greatly affected by dirt on the optic.
Note carefully the instructions con-
cerning cleaning under section 11.1.
Observe the hygiene regulations under
section 11. Cleaning and Disinfection.
10.1 IFC Optic
Turn the adjusting ring (48) on the handpiece in
order to focus the IFC Optic.
The extreme depth of field of the
VistaCam Digital means that subse-
quent adjustment of focus in the mouth
of the patient is not necessary.
Macro
Intraoral
Extraoral
4
48
Use of the Appliance

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10.3 Recording images: Live /
Freeze modes
Operating the pressure sensitive release (6) al-
lows images on the monitor to be switched from
Live Mode to Freeze Mode (freeze frame) as well
as being saved.
Freeze frame images:
• Use your fingers to operate the pressure sen-
sitive ring of the pressure sensitive release by
pressing together "briefly and lightly". The
freeze frame is now displayed on the monitor.
Live images:
• Use your fingers to again operate the pressure
sensitive ring of the pressure sensitive release
by pressing together "briefly and lightly". The
live image is now again displayed on the
monitor.
Save images:
• Use your fingers to operate the pressure sen-
sitive ring of the pressure sensitive release by
pressing together this time "briefly but firmly".
The image will be recorded in image segments
by the Video Mode.
The individual functions of the pressure
sensitive release can be individually set
up using DBSWIN (fig. 7). See the enc-
losed instruction sheet "VistaCam Digital
Installation and Configuration "
order number 9000-618-89/01
6
6
10.2 Switch on the VistaCam Digital
Example using image editing software
DBSWIN
• Start DBSWIN and select a patient.
• Take the handpiece (1) out of its handpiece
holder (2). The camera will automatically
switch on.
• Select Video-module.
• The live image is now displayed on the
monitor.
The camera automatically switches off
after 10 minutes continuous operation.
Use the image editing software and the
Live/Freeze Button to continue operati-
on with the camera.
7
1
2
5

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10.4 Switch off the VistaCam Digital
• Slide the hygienic protective cover off carefully
after use and dispose.
• Disinfect the handpiece using a non-aggres-
sive disinfection cloth, e.g. Dürr FD 350. See
also section 11. Disinfection and Cleaning
• Place the handpiece back into its holder cor-
rectly. The camera will turn off automatically.
8

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11
9
10
10.5 Using hygienic protective
covers
Hygiene protection:
For hygienic reasons the VistaCam
Digital should only be used together
with hygienic protective covers
when being used in intraoral areas.
Carefully slide the hygienic protecti-
ve cover off after use and dispose of
in the correct manner.
Hygienic protective covers are
disposable items and must not be
reused.
In order to achieve better image quality
for extraoral images then it is a distinct
advantage not to use the hygienic pro-
tective covers.
• Hold the handpiece such that the window of
the optic itself faces downwards.
• Lift the white edge to the hygienic protective
cover and slide the IFC Optic carefully inside.
Slide the hygienic protective cover over in
such a way that the plastic part of the pa-
ckaging faces upwards.
• Once the tip of the optic is right at the front,
stretch the hygienic protective cover 2-3 mm
so that the sheath part of the cover is tightly
pressed against the optic.
• Use the tip of a finger to carefully press the
sheath tight against the window of the optic
itself, in order to remove any small air pockets
that may be present between the sheath and
the window of the optic.
• Hold the white edge to the hygienic protective
cover firmly and peel away the upper plastic
side of the packaging towards the IFC Optic
• Peel the paper underside from the IFC Optic
towards the handpiece.

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11. Disinfection and
Cleaning
Only disinfectants and cleaning agents
specifically approved by Dürr Dental
should be used.
Other Cleaning and disinfectants can
lead to damage of the VistaCam Digital
and any accessories.
11.1 Cleaning the optical window
We strongly recommend using the cleaning set
for Dürr VistaCam-Optic, order number
2101-025-50.
Using a disinfection cloth, or a liquid
disinfectant for cleaning the optical win-
dow is not recommended. These could
have dirt deposits.
11.2 Cleaning and disinfecting
handpiece and other
accessories
The handpiece and accessories can be cleaned
and disinfected using a disinfection cloth such
as Dürr FD 350.
Damage to the handpiece:
Do not use any sharp or abrasive
cleaning materials. The surface of
the appliance may be damaged.
Do NOT place the handpiece in an
autoclave, immerse in disinfectant
or clean using a disinfectant spray.
These could all lead to the handpie-
ce being destroyed.
12. Maintenance
The VistaCam Digital is maintenance-free.

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13. Tips for Operators and Service Technician
13.1 Problem 13.2 Possible cause 13.3 Solution
1. Image is opaque, milky • The hygienic protective cover
has not been correctly placed
• Place the hygienic protective
cover in correct position
(see section 10.5)
• IFC Optic is dirty • Clean the optic lens
(see section 11. Disinfection
and Cleaning )
• Some sort of fluid has seeped
into the optic on the
handpiece.
• The handpiece must be sent
for repair to Dürr Dental.
2. Image is too dark • LEDs are defect. • The handpiece must be sent
for repair to Dürr Dental.
3. No image • USBY-adaptor is not
connected
• see sections
9. Electrical Connection and
Commissioning
10. Operation
• Cable has not, or not correct-
ly, been connected
Trouble-shooting

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DÜRR DENTAL AG
Höpfigheimer Strasse 17
74321 Bietigheim-Bissingen
Germany
Fon: [phone]
www.duerr.de
[email protected]