Durr Dental VistaCam iX Proxi User manual

VistaCam iX Proxi
Installation and Operating Instructions
9000-618-254/30
 1608V0034&
EN

9000-618-254/30 1608V003 1
7 Cleaning and disinfection � � � � � � � � 11
7�1 Cleaning and disinfect the in-
terchangeable head � � � � � � � � � 11
7�2 Cleaning the optical element� � � 11
7�3 Preparing the positioning hold-
er� � � � � � � � � � � � � � � � � � � � � � � 12
Troubleshooting
8 Tips for operators and service
technicians � � � � � � � � � � � � � � � � � � � 14
Contents
EN
Important information
1 About this document � � � � � � � � � � � � 2
1�1 Warnings and symbols � � � � � � � � 2
1�2 Copyright information� � � � � � � � � 2
2 Safety � � � � � � � � � � � � � � � � � � � � � � � � 3
2�1 Intended use � � � � � � � � � � � � � � � 3
2�2 Improper usage � � � � � � � � � � � � � 3
2�3 General safety information � � � � � 3
2�4 Qualified personnel� � � � � � � � � � � 3
2�5 Protection from electric shock � � 3
2�6 Only use genuine parts� � � � � � � � 4
2�7 Transport � � � � � � � � � � � � � � � � � � 4
2�8 Disposal� � � � � � � � � � � � � � � � � � � 4
Product description
3 Overview� � � � � � � � � � � � � � � � � � � � � � 5
3�1 Scope of delivery � � � � � � � � � � � � 5
3�2 Accessories � � � � � � � � � � � � � � � � 5
3�3 Special accessories � � � � � � � � � � 5
3�4 Disposable materials � � � � � � � � � 5
3�5 Wear parts and spare parts � � � � 5
4 Technical data� � � � � � � � � � � � � � � � � � 6
4�1 Proxi interchangeable head � � � � 6
5 Operation � � � � � � � � � � � � � � � � � � � � � 6
5�1 Evaluation � � � � � � � � � � � � � � � � � 7
Operation
6 Operation � � � � � � � � � � � � � � � � � � � � � 8
6�1 Preparation of the device � � � � � � 8
6�2 Positioning the unit correctly� � � � 9
6�3 Operating the unit � � � � � � � � � � 10

29000-618-254/30 1608V003
Other symbols
These symbols are used in the document
and on or in the unit:
Note, e�g� specific instructions re-
garding efficient and cost-effective
use of the unit�
Comply with the specification in the
accompanying documents�
CE labelling
Date of manufacture
Dispose of correctly in accordance
with EU Directive 2012/19/EU
(WEEE)�
Do not reuse�
Application part type B
Steam sterilise at 134 °C
Wear protective gloves�
1.2 Copyright information
All names of circuits, processes, names,
software 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 in-
structions are not followed, Dürr Den-
tal will not be able to offer any war-
ranty or assume any liability for the
safe operation and the safe function-
ing 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
The warnings are structured as follows:
SIGNAL WORD
Description of the type and
source of danger
Here you will find the possible con-
sequences 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

9000-618-254/30 1608V003 3
Important information
2.3 General safety information
iWhen operating this device always ob-
serve all guidelines, laws, and other rules
and regulations that are applicable at the
site of operation�
iPrior to each use, check condition of the
device and make sure it is in perfect
working order�
iDo not convert or modify the units�
iObserve the Installation and Operating In-
structions�
iMake the Installation and Operating In-
structions available to the person operat-
ing the device at all times�
2.4 Qualified personnel
Operation
Operating personnel are dentists and dental
personnel�
They must ensure safe and appropriate han-
dling on the basis of their training and
know-how�
iInstruct or have every user instructed in
handling the unit�
Installation and repairs
iInstallation, readjustments, alterations,
upgrades and repairs must be carried out
by Dürr Dental or by qualified personnel
specifically approved and authorized by
Dürr Dental�
2.5 Protection from electric shock
iWhen working on the units observe all
the relevant 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�
2 Safety
Dürr Dental has designed and constructed
this device so that when used properly and
for the intended purpose there is no danger
to people or property� Nevertheless, residual
risks can remain� You should therefore ob-
serve the following notes�
2.1 Intended use
The Proxi interchangeable head is an at-
tachable head for the VistaCam iX hand-
piece as of serial number B000484�
The Proxi interchangeable head enables the
detection of approximal caries by virtue of
the translucence of the healthy tooth enamel
to light waves in the infra-red range�
2.2 Improper usage
Any other usage or usage beyond this
scope is deemed to be improper� The man-
ufacturer accepts no liability for damages
resulting from this� In these cases the user/
operator will bear the sole risk�
WARNING
Risk of explosion due to ignition
of combustible materials
iDo not operate the unit in any
rooms in which inflammable mix-
tures may be present, e�g� in op-
erating theatres�
CAUTION
The light of the camera is very
bright and can dazzle
iDo not use the camera directly
on the eye�
EN

49000-618-254/30 1608V003
Important information
2.7 Transport
The original packaging provides optimum
protection for the device during transport�
If required, original packaging for the unit
can be ordered from Dürr Dental�
Dürr Dental does not accept any re-
sponsibility or liability for damage oc-
curring during transport due to the
use of incorrect packaging, even
where the unit is still under guarantee�
iOnly transport the device in its original
packaging�
iKeep the packing materials out of the
reach of children�
2.8 Disposal
Unit
The unit must be properly disposed
of� Within the European Union, the
unit must be disposed of in accord-
ance with EU Directive 2012/19/EU
(WEEE)�
iIf you have any questions about the cor-
rect disposal of parts, please contact
your dental trade supplier�
Observe the EMC rules concerning med-
ical devices
For information on electromagnetic
compatibility (EMC), see the installa-
tion and operating instructions for
VistaCam iX (order number 9000-
618-176)�
2.6 Only use genuine parts
iOnly use Dürr Dental parts or accessories
and special accessories specifically ap-
proved by Dürr Dental�
iOnly use only genuine working parts and
spare parts�
DÜRR MEDICAL accepts no liability
for damages or injury resulting from
the use of non-approved accessories
or special accessories, or from the
use of non-genuine working parts or
spare parts�
The use of non-approved accesso-
ries, special accessories or non-genu-
ine working parts / spare parts
(e�g�mains cable) can have a nega-
tive effect in terms of electrical safety
and EMC�
EN

9000-618-254/30 1608V003 5
3.2 Accessories
The following articles are necessary to oper-
ate the unit, depending on the actual appli-
cation:
Positioning holder (3 pieces) � � 2108-132-52
Poly disposable hygienic pro-
tective covers, Proxi
(500 pieces) � � � � � � � � � � � � � �2108-010-60
Poly disposable hygienic pro-
tective covers, Proxi
(100 pieces) � � � � � � � � � � � � � � 2108010053
3.3 Special accessories
The following optional items can be used
with the unit:
Storage box � � � � � � � � � � � � � � 2108-135-50
3.4 Disposable materials
The following materials are consumed dur-
ing operation of the device and must be or-
dered separately:
Poly disposable hygienic pro-
tective covers, Proxi
(500 pieces) � � � � � � � � � � � � � �2108-010-60
Poly disposable hygienic pro-
tective covers, Proxi
(100 pieces) � � � � � � � � � � � � � � 2108010053
Cleaning and disinfection
FD 350 Disinfectant wipes� � CDF350C1040
FD 333 rapid surface
disinfectant � � � � � � � � � � � � � CDF333C6150
FD 322 rapid surface
disinfectant � � � � � � � � � � � � � CDF322C6150
FD 366 sensitive disinfectant
for sensitive surfaces� � � � � � CDF366C6150
3.5 Wear parts and spare parts
The following wear parts must be replaced
at regular intervals:
Positioning holder (3 pieces) � � 2108-132-52
3 Overview
1
2
3
4
5
6
7
1 Proxi interchangeable head
2 Handpiece with interchangeable head
3 Handpiece holder
4 USB connecting cable (to computer)
5 Positioning holder
6 Poly disposable hygienic protective
cover, Proxi
7 Storage box (optional)
3.1 Scope of delivery
The following items are included in the
scope of delivery:
Proxi interchangeable head
for VistaCam iX . . . . . . . . . . .2108-130-56
– Proxi interchangeable head
– Positioning holder (3 pieces)
– Poly disposable hygienic protective
covers, Proxi (20 pieces)
– Installation and operating instructions
– Quick start instructions
Product description
EN

69000-618-254/30 1608V003
Product description
5 Operation
1
2
3
4
5
1 Positioning holder
2 Optical system
3 Proxi interchangeable head
4 Capture ring
5 Handpiece
The VistaCam iX handpiece with the Proxi
interchangeable head creates a black and
white image for detecting caries in the ap-
proximal region�
The optical system is placed on the row of
teeth and an image is created by actuating
the capture ring� The positioning holder fa-
cilitates the placement of the optical system
on the row of teeth� In addition, the posi-
tioning holder screens off the image area
and minimises the penetration of external
light�
Two powerful infra-red LEDs are installed in
the optical system� The infra-red light illumi-
nates the tooth and is reflected with varying
intensity depending on the translucence
(light transmission) of the dental structures�
The reflected light is detected by the optical
system and is evaluated as a black and
white image by the DBSWIN imaging pro-
gram (from Version 5�6) or VistaEasy (from
Version 5�6)�
4 Technical data
4.1 Proxi interchangeable head
Proxi interchangeable head
Light source LED
Wavelength nm 850
Sharpness level mm 7
Handpiece with Proxi interchangeable
head
Length mm 190
Weight (without cable) g51
EN

9000-618-254/30 1608V003 7
Product description
Figure 2: Enamel lesions on the mesial
surface can be seen as wedge-shaped
structures within the dark translucent tooth
enamel. The lesions reach to the inner half
of the enamel.
The system cannot distinguish between
structures with the same amount of translu-
cency� Thus it is not suitable for the diagno-
sis of:
– Secondary caries under restorations
– Dentine caries
– Central occlusal caries
The tooth enamel appears brighter in pa-
tients with highly opaque tooth enamel� The
caries diagnosis is complicated here by the
low difference in contrast�
5.1 Evaluation
The black and white image shows struc-
tures with varying translucency as different
levels of brightness� The lower the translu-
cency, the higher the reflection of the in-
fra-red light and the brighter the structure� It
is possible to make out to following struc-
tures:
– Healthy enamel appears very dark, high
translucency
– Approximal caries appears bright, low
translucency
– Dentine appears bright, low translucency
– Several restorations appears bright, no
translucency
Figure 1: Any lesions on the mesial surface
can be recognised as a wide bright strip
up to the enamel/dentine limit.
EN

89000-618-254/30 1608V003
Using the hygienic protective cover
WARNING
Danger of cross contamination
with failure to use or repeated
use of a disposable hygienic
protective cover
iDo not use the unit without a hy-
gienic protective cover�
iDo not use the hygienic protec-
tive cover more than once (dis-
posable item)�
Wear protective gloves when applying
the disposable hygienic protective
cover�
iHold the camera so that the optical ele-
ment faces down�
iLift the white edge of the disposable hy-
gienic protective cover and slide the
camera head carefully into the cover� The
transparent plastic side must face up-
wards�
iStretch the disposable hygienic protec-
tive cover an extra 2 - 3mm so that the
cover presses tightly against the optical
element�
iCarefully press the disposable hygienic
protective cover against the optical win-
dow using your fingers� Ensure that there
For information on the assembly, con-
nection, and installation of the device,
see the assembly and operating in-
structions of the VistaCamiX hand-
piece (9000-618-176) and the instal-
lation and configuration manual of the
VistaCamiX (document no� 9000-
618-179)�
6 Operation
6.1 Preparation of the device
Place on the interchangeable head
iEnsure that the handpiece and the inter-
changeable head are completely dry�
iHold the interchangeable head and hand-
piece so that the optical element is on
the side of the image sensor�
iSlide the interchangeable head onto the
handpiece until it clicks into place�
Operation
EN

9000-618-254/30 1608V003 9
Operation
obscure the optical element of the inter-
changeable head�
6.2 Positioning the unit correctly
The camera must be positioned correctly to
achieve a good picture quality�
iPosition the camera in a line with the
teeth�
iPlace the spacer vertically on the tooth
surface� The spacer must come into con-
tact with the teeth�
are no air bubbles between the optical
window and the disposable hygienic pro-
tective cover�
iHold the disposable hygienic protective
cover firmly on the white edge and pull off
the transparent plastic side in the direc-
tion of the camera head�
iPull off the paper underside from the
camera head in the direction of the hand-
piece�
Placing on the positioning holder
WARNING
Danger of cross-contamination
when used without reprocessing
or following incorrect repro-
cessing
iSterilise the light protection in
the steam steriliser (see "7�3
Preparing the positioning hold-
er") before each use�
iPlace the positioning holder onto the in-
terchangeable head from above� Make
sure the positioning holder itself does not
EN

10 9000-618-254/30 1608V003
Operation
6.3 Operating the unit
iReduce the penetration of external light�
Turn off or dim sources of external light
(e�g� operating lights)�
iDry the row of teeth with compressed air�
iPlace the camera with positioning holder
on the row of teeth above the approximal
area� The two infrared LEDs illuminate the
respective mesial and distal enamel area
of the two adjacent teeth�
iPress on one point of the capture ring�
The camera switches to "Freeze" mode�
The freeze frame will be displayed in the
imaging program / transmitted to the
monitor�
iEdit the image using the imaging pro-
gram and save� (For further information,
refer to the software manual�)
iTo return to "Live" mode, press on a point
on the capture ring again�
iEnsure that the relevant approximal area
is located in the centre of the image sec-
tion�
iIf the structure underneath the enamel is
not visible, change the angle of the cam-
era slightly�
EN

9000-618-254/30 1608V003 11
Operation
7.2 Cleaning the optical element
NOTICE
Damage of the optical element
from incorrect cleaning
iOnly use the cleaning set for
VistaCam optical element� Disin-
fectant residues soil the optical
element�
iClean the window of the optical window
of the interchangeable head from outside
using the microfibre cloth with a drop of
VistaCam optical element cleaner or alco-
hol�
7 Cleaning and
disinfection
7.1 Cleaning and disinfect the in-
terchangeable head
Use the following cleaning and disinfectant
agents as disinfectant wipes:
– FD 350 Disinfectant wipes
– FD 333 wipes disinfectant wipes
– FD 322 rapid surface disinfectant
– FD 333 rapid surface disinfectant
– FD 366 sensitive disinfectant for sensi-
tive surfaces
NOTICE
Incorrect cleaning and disin-
fection can damage the inter-
changeable head
iOnly clean the surface of the in-
terchangeable head�
iNever clean the interchangeable
head from inside�
iOnly use disinfection and clean-
ing agents specifically approved
by Dürr Dental�
iDo not use any aggressive or
abrasive cleaning materials�
iOnly clean the interchangeable
head using wipe disinfection�
iDo not clean the interchangea-
ble head by submerging or
spraying in combination with
disinfectant�
iDo not steam sterilise the inter-
changeable head�
iWipe the surface of the interchangeable
head with a disinfectant wipe (e�g�
FD350)�
Result:
In order to protect the interchangea-
ble head from soiling during storage,
place the interchangeable head in its
storage box after cleaning�
EN

12 9000-618-254/30 1608V003
Operation
7.3 Preparing the positioning
holder
The following instructions have been validat-
ed by DürrDental in order to prepare the
product for reuse�
Reprocessing procedure:
1� Cleaning and disinfecting (automatic or
manual)
2� Sterilising in the steam steriliser
The person performing the reprocessing is
responsible for ensuring that the reprocess-
ing carried out with the utilised equipment,
materials and personnel achieve the desired
results� Given any deviation from the validat-
ed reprocessing, the person performing the
reprocessing is responsible for the effective-
ness and for any potential adverse conse-
quences of the reprocessing�
iCarry out the validation and routine moni-
toring of the reprocessing process�
iFollow the applicable national regulations
during cleaning, disinfection, sterilisation
and storage�
Automatic cleaning and disinfecting
Use cleaning and disinfecting equip-
ment in accordance with the manu-
facturer's instructions�
iRemove heavy soiling with a disposable
disinfection wipe (e�g� FD350)�
iPlace the product in the unit in such a
way that it is rinsed thoroughly and the
water can run off�
iCarry out the cleaning and disinfection
cycle in accordance with the manufactur-
er's instructions�
iAfter the end of the cleaning and disin-
fection cycle, check the product for any
remaining soiling� If necessary, repeat the
cycle�
iWith the interchangeable head removed,
clean the surface of the image sensor us-
ing the cleaning set for VistaCam Optik�
iIf particles can still be seen on the image,
dry clean the interchangeable head from
the inside with compressed air or with a
foam rod (from the cleaning set)�
EN

9000-618-254/30 1608V003 13
Operation
iComply with all national and local guide-
lines and standards regarding the sterili-
sation of medical devices�
Storage
iStore the product protected against con-
tamination�
Manually clean and disinfect using the
wet chemical process
When manually cleaning using the
wet chemical process, use a VAH/
DGHM listed disinfectant� Comply
with the reaction times stated in the
disinfectant manufacturer information�
iRemove heavy soiling with a disposable
disinfection wipe (e�g� FD350)�
iImmerse the product in an instrument
disinfection and cleaning solution (e� g�
ID212, ID212 forte, ID213)�
iAfter the end of the cleaning and disin-
fection cycle, check the product for any
remaining soiling� If necessary, repeat the
cycle�
iRinse parts thoroughly with water�
iDry the spacer with hygienically clean
disposable wipes or with compressed air�
Steam sterilising
WARNING
Incorrect sterilisation reduces
effectiveness and can damage
the product.
iOnly steam sterilisation is per-
mitted�
iComply with the specified pro-
cess parameters�
iDo not use any other methods�
Process parameters
Temperature: 134 °C
Gauge pressure above that of envi-
ronment: 2�16 bar / 0�216 MPa
Holding time: 5 min
iParts for sterilisation must be sterilised
before each use in a small steam steriliser
according to EN13060 with a type B
sterilisation cycle and final drying�
iComply with the manufacturer informa-
tion regarding usage of the steam sterilis-
er and the correct placement of parts for
sterilisation�
EN

14 9000-618-254/30 1608V003
8 Tips for operators and service technicians
Any repairs above and beyond routine maintenance must only be carried out by suita-
bly qualified personnel or by one of our service technicians�
Problem Probable cause Solution
Image is tool light in a
specific region
The angle of the camera to
the tooth is not ideal
iChange the holding angle of
the camera to the tooth�
Snow effect on the
image
Clearance of the camera to
the tooth is too high, no opti-
mum illumination
iEnsure that the spacer does
not come into contact with
the teeth�
Camera used without spacer iAlways use a spacer for
imaging using the Proxi
interchangeable head�
Dark shadow in the
dentine
Hygienic protective cover or
optical element soiled
iCheck the hygienic protec-
tive cover, clean or replace if
necessary�
iCheck the optical element
and clean if necessary (see
"7�2 Cleaning the optical
element")�
Image is too light or
too dark
Incorrect settings in the imag-
ing software
iAlter the brightness of
the image in the imaging
software�
iAdapt the brightness in the
configuration of the imaging
software to change the
brightness settings�
Too many reflections in
the image
Saliva in the mouth iDry the row of teeth with a
cloth or compressed air�
iChange the holding angle of
the camera lightly�
Teeth with large-surface fill-
ings and a small surface with
intact enamel in the image
section
iThis image does not permit
exact analysis�
Troubleshooting
EN

Hersteller/Manufacturer:
DÜRR DENTAL SE
Höpfigheimer Str. 17
74321 Bietigheim-Bissingen
Germany
Fon: [phone]
www.duerrdental.com
[email protected]