Durr Dental VistaCam iX Poly User manual

VistaCam iX Poly
Installation and Operating Instructions
9000-618-201/30
 1411V0054&
EN

9000-618-201/30 1411V005 1
Usage
7 Instructions for use � � � � � � � � � � � � 11
7�1 Prepare the unit � � � � � � � � � � � � 11
7�2 Using the appliance � � � � � � � � � 13
8 Cleaning and disinfecting � � � � � � � 15
8�1 Cleaning and disinfecting of
interchangeable head� � � � � � � � 15
8�2 Prepare light protector � � � � � � � 15
9 Function control� � � � � � � � � � � � � � � 16
9�1 Check light intensity � � � � � � � � � 16
Trouble-shooting
10 Tips for Operators and
Technicians � � � � � � � � � � � � � � � � � � 17
Contents
EN
Important information
1 Documentation � � � � � � � � � � � � � � � � 2
1�1 Warnings and symbols � � � � � � � � 2
1�2 Notes on copyright� � � � � � � � � � � 3
2 Safety � � � � � � � � � � � � � � � � � � � � � � � � 3
2�1 Correct use � � � � � � � � � � � � � � � � 3
2�2 Incorrect use � � � � � � � � � � � � � � � 3
2�3 General safety notes � � � � � � � � � 4
2�4 Qualified personnel� � � � � � � � � � � 4
2�5 Protection against electrical
current� � � � � � � � � � � � � � � � � � � � 4
2�6 Protect from energy intensive
light � � � � � � � � � � � � � � � � � � � � � � 4
2�7 Only use original parts � � � � � � � � 5
2�8 Transport � � � � � � � � � � � � � � � � � � 5
2�9 Disposal� � � � � � � � � � � � � � � � � � � 5
Product description
3 Overview � � � � � � � � � � � � � � � � � � � � � 6
3�1 Delivery Contents� � � � � � � � � � � � 6
3�2 Accessories � � � � � � � � � � � � � � � � 6
3�3 Special accessories � � � � � � � � � � 6
3�4 Disposable materials � � � � � � � � � 6
3�5 Working parts and spare parts � � 6
4 Technical data � � � � � � � � � � � � � � � � � 7
4�1 Poly Interchangeable Head� � � � � 7
4�2 Power unit � � � � � � � � � � � � � � � � � 7
5 Function � � � � � � � � � � � � � � � � � � � � � � 8
Mounting
6 Installation � � � � � � � � � � � � � � � � � � � � 9
6�1 Safe connection of appliance � � � 9
6�2 Connecting up the device� � � � � � 9

29000-618-201/30 1411V005
Possible risk of danger of serious injury
or death
– CAUTION
Risk of danger of minor injuries
– NOTICE
Risk of serious damage
Further symbols
These symbols are used within the docu-
mentation and on the unit itself:
Notes, e�g� special instructions con-
cerning economical use of the unit�
Observe the accompanying docu-
mentation�
CE-labeling
Date of manufacture
Dispose of product correctly and in
accordance with EU directive
(2002/96/EG-WEEE)�
Only use once�
Part type B
Steam sterilise at 134 °C
Wear protective glasses (goggles)�
Wear protective gloves
1 Documentation
These Installation and Operating Instructions
form an integral part of the unit� They con-
form to the relevant version of the equip-
ment and the status of technology valid at
the time of first operation�
Dürr Dental cannot guarantee
smooth operation and safe function
of the unit and will not accept any li-
ability where the instructions and
notes contained in these installation
and operating instructions are not
strictly observed�
This translation has been carried out in all
good faith� The original German version is
decisive� Dürr Dental accepts no liability for
incorrect translation�
1.1 Warnings and symbols
Warnings
The warnings in this document are there to
point out possible injury to persons or dam-
age to machinery�
The following warning symbols are used:
General warning symbol
The warnings are structured as follows:
SIGNAL WORD
Description of type and source
of danger
Possible consequences of ignoring
the safety warning here
• Measures to be taken to avoid
any possible danger�
The signal word differentiates between
different levels of danger:
– DANGER
High risk of danger of serious injury or
death
– WARNING
Important information
EN

9000-618-201/30 1411V005 3
Important information
2 Safety
Dürr Dental has designed and constructed
this appliance so that when used correctly
there is no danger to people or property�
Nevertheless, there are residual risks�
Please follow the instructions below careful-
ly�
2.1 Correct use
The Poly interchangeable head is a plug-on
head with polymerization lamp for the Vista-
CamiX handpiece�
This polymerization lamp is designed for
light-hardening dental materials (e�g� adhe-
sives, composites and compomers), which
can be hardened using rays of blue light
with wavelengths of 460±10nm (photoiniti-
ator camphor quinone)�
2.2 Incorrect use
Any use of this appliance above and beyond
that specifically described in these instruc-
tions will be deemed to be as not according
to the intended use� The manufacturer can-
not be held liable for any damage resulting
from incorrect usage� The user bears all
risks�
The Poly interchangeable head is not suita-
ble for polymerisation of dental materials
which cannot be hardened using light of
wavelengths 460±10nm�
WARNING
Risk of explosion due to inflam-
mation of combustible materials
• Do not use the appliance in rooms
in which combustible mixtures
may be present, e�g� in operating
theatres�
1.2 Notes on copyright
All circuits, processes, names, software and
appliances quoted are protected under in-
dustrial property rights�
Any reprinting of the technical documenta-
tion, in whole or in part, is subject to prior
approval of Dürr Dental being given in writ-
ing� EN

49000-618-201/30 1411V005
Important information
2.5 Protection against electrical
current
• When working on and with the appliance
always observe the local electrical safety
procedures�
• Never come into contact with patients
and open plug-in connections on the ap-
pliance at the same time�
• Damaged supply lines and connections
must be replaced immediately�
Observe guidelines for electro-magnet-
ic compatibility for medical devices
For further information on electro-
magnetic compatibility (EMC), see
the installation and operating in-
structions for VistaCam iX (order
number 9000-618-176)�
2.6 Protect from energy intensive
light
The polymerisation lamp is a product of Risk
group 2 according to EN62471� If the eyes
are exposed to optical radiation for a pro-
longed period, the radiation can damage the
eyes�
• Do not look into the lamp�
• Only use a polymerisation lamp with light
protection�
• Wear polymerisation eye protection that
absorbs UV and blue light�
2.3 General safety notes
• Before using the appliance observe any
and all guidelines, laws, regulations and
other restrictions which may apply to the
appliance�
• Before each use check the function and
condition of the appliance�
• Do not convert or change the appliance in
any way�
• Observe the Installation and Operating In-
structions precisely�
• Keep the Installation and Operating In-
structions in an accessible place so that
the operator has instant access to them�
2.4 Qualified personnel
Instructions for use
Persons that operate the appliance are den-
tists and dental personnel�
As a result of their training and know-how,
they must ensure safe and appropriate han-
dling�
• Each operator using the appliance must
be trained in its handling�
Installation and repair
• Installation, resetting, alterations, exten-
sions and repairs must be carried out by
Dürr Dental or by qualified personnel spe-
cifically approved and authorized by Dürr
Dental�
EN

9000-618-201/30 1411V005 5
Important information
2.8 Transport
The original packaging offers the optimum
protection for the appliance during trans-
port�
If required, the original packaging for the
unit can be ordered at Dürr Dental�
Dürr Dental cannot accept any liabili-
ty for damage caused during trans-
port by the use of unsuitable pack-
aging, this is also valid during the
warranty term�
• Only transport the appliance in its original
packaging whenever possible�
• Keep the packing materials out of the
reach of children�
2.9 Disposal
Appliance
Dispose of the appliance correctly�
Within the European Union dispose
of the appliance according to EU di-
rective 2002/96/EG (WEEE)�
• If you have any questions concerning cor-
rect disposal, please contact Dürr Dental
or your usual dental supplier�
2.7 Only use original parts
• Only use accessories and special acces-
sories stipulated or approved by Dürr
Dental�
• Only use original working parts and spare
parts�
Dürr Dental accepts no liability for
damage or injury caused by the use
of accessories, special accessories
or parts other than original working
parts and spare parts which were
not specifically approved by the
manufacturer�
EN

69000-618-201/30 1411V005
3.2 Accessories
The following articles are necessary to oper-
ate the unit, depending on actual applica-
tion:
Disposable protective sheaths
(3 pieces) � � � � � � � � � � � � � � � �2108-132-51
Poly disposable protective
sheaths (500 pieces) � � � � � � � � 2108-010-60
Polymerisation protective
glasses � � � � � � � � � � � � � � � � � �2108-020-50
3.3 Special accessories
The following articles can be used with the
unit but are optional:
Storage box � � � � � � � � � � � � � �2108-135-50
3.4 Disposable materials
The following materials are used when oper-
ating the unit and must be ordered sepa-
rately:
Poly disposable hygienic pro-
tective covers, Proxi
(500 pieces) � � � � � � � � � � � � � �2108-010-60
Cleaning and disinfecting
FD 350 Disinfectant wipes� � CDF350C1040
FD 333 surface disinfectant� CDF333C6150
FD 322 surface disinfectant� CDF322C6150
FD 366 sensitive disinfection of
delicate surfaces� � � � � � � � � CDF366C6150
3.5 Working parts and spare
parts
The following working parts must be re-
placed at regular intervals:
Disposable protective sheaths
(3 pieces) � � � � � � � � � � � � � � � �2108-132-51
3 Overview
12
3
4
5
6
7
1 Poly interchangeable head
2 Light protection
3 Polymerisation protective glasses
4 Poly disposable protective sheath
5 Storage box (optional)
6 USB-connecting cable
7 Power unit with country specific adapter
3.1 Delivery Contents
The following articles are supplied with the
unit:
Poly interchangeable head
for VistaCam iX . . . . . . . . . .2108-130-52
– Poly Interchangeable Head
– Disposable protective sheaths (3 pieces)
– USB-connecting cable with power unit
– Poly disposable protective sheaths (20
pieces)
– Polymerisation protective glasses
– Installation and Operating Instructions
– Short introduction
Product description
EN

9000-618-201/30 1411V005 7
Product description
4.2 Power unit
Power supply type
Manufacturer GlobTek
Inc�
Model GTM41076-
0612-X�X
Electrical data of power unit
Nominal voltage V AC 100 - 240
Electrical frequency Hz 47 - 63
Max� nominal current A0�5
Output voltage V DC 12
Max� output voltage
fluctuations %±1
Output current A0�5
Rated power W 6
Connection cable
Cable length cm 250
4 Technical data
4.1 Poly Interchangeable Head
Polymerisation lamp
Light source LEDs
Wavelength nm 460
Light intensity mW/
cm21000
Diameter of the
optics mm 10
Handpiece with Poly interchangeable
head
Length mm 205
Weight (without
cable) g55
Operating mode* T1/T2 = 12 %
40 s/5�5 min
(switch-on/off time)
* At an ambient temperature of max�
40 °C and while observing the switch-
on/off time, the handpiece/the inter-
changeable head reaches a maximum
surface temperature of 60 °C�
EN

89000-618-201/30 1411V005
Product description
After every 5 seconds the handpiece vi-
brates once and there is an audible signal�
After 20 seconds the handpiece vibrates
twice, there is a repeated audible signal (2x)
and the appliance automatically switches
off�
5 Function
1
2
3
4
5
1 Light protection
2 Optical element with LED located direct-
ly behind
3 Poly interchangeable head
4 Pressure sensitive release
5 Handpiece
The VistaCam iX handpiece with the Poly in-
terchangeable head acts as a polymerisa-
tion lamp which emits blue light in order to
harden appropriate dental materials� The
light protector focusses the light onto one
particular area and protects the operator
from any glare�
The appliance is switched on or off by
pressing the manual capture� The maximum
length of light emission is limited to 20 sec-
onds�
The actual light intensity is increased in two
steps after switching on� For the first 5 sec-
onds the light intensity is 520mW/cm2, after
this the light intensity increases to a con-
stant 1000mW/cm2�
EN

9000-618-201/30 1411V005 9
6.2 Connecting up the device
The power supplied via the USB-connecting
cable of the VistaCam iX for the camera in-
terchangeable head is not sufficient for the
Poly interchangeable head� Therefore the
handpiece must be connected to the
USB-connecting cable with power unit sup-
plied�
The USB-connecting cable with
power unit allows all available Vista-
Cam iX interchangeable heads to be
operated�
To operate the Poly interchangeable head
connection to the power unit is fully suffi-
cient without added connection to a com-
puter� The application as polymerisation
lamp requires no software�
• Connect the appropriate country specific
adapter to the power unit�
• Connect the power unit to the USB-com-
bination connector�
6 Installation
6.1 Safe connection of appliance
Danger can arise when connecting units
with each other or to parts of the system
(e�g� through discharge current)�
• Only connect units when there can be no
question of danger to operator or to pa-
tient�
• Only connect units when there can be no
environmental impairment through such
interconnection�
• When it is not clear from the unit data
sheets that such connection will cause no
danger, then a qualified expert should be
consulted to ensure no danger (e�g� one
of the product manufacturers)�
• Observe the specifications of IEC60601-1
(EN60601-1) when connecting the appli-
ance with other appliances,e�g� a PC sys-
tem, as well as outside the vicinity of the
patients�
• Only connect additional appliances (e�g�
computer, monitor, printer) which at least
comply with the IEC60950-1
(EN60950-1) standard�
A master copy of the system manu-
facturer‘s declaration according to
Article 12 of Directive 93/42/EWG
can be found in our download sec-
tion under www�duerr�de (Document
No� 9000-461-264)�
Mounting
EN

10 9000-618-201/30 1411V005
Mounting
• Connect the connecting cable to the
camera�
• If the appliance is to be used with other
interchangeable heads, connect the
handpiece using the USB-combination
connector to a computer�
• Plug the power unit into the mains supply
socket�
EN

9000-618-201/30 1411V005 11
Slide interchangeable head on
• Ensure that the handpiece and the inter-
changeable head are completely dry�
• Hold the interchangeable head and the
handpiece such that the optical element is
on the opposite side to the image sensor�
• Slide the interchangeable head onto the
handpiece until it locks into place�
Use disposable protective sheaths
WARNING
There is a danger of cross con-
tamination where disposable
protective sheaths are not used
or are used more than once
• Do not use the camera without fit-
ting a disposable protective
sheath�
• Do not use the disposable protec-
tive sheath more than once (dis-
posable item)�
When applying the disposable pro-
tective sheath wear protective
gloves�
7 Instructions for use
WARNING
Injury through light sensitivity
• Persons who are light-sensitive or
who are taking light-sensitive
medication (photo-sensitizers)
should not be exposed to the light
from the appliance�
7.1 Prepare the unit
NOTICE
Dirty or damaged optical ele-
ments can lead to insufficient
hardening
• Check that the optical element is
clean, if necessary clean�
• If the optical element looks
opaque or badly scratched,
change the interchangeable head�
• Check the light intensity with ap-
propriate test device�
• Before every use clean and disinfect the
appliance (see "8 Cleaning and disinfect-
ing")�
Usage
EN

12 9000-618-201/30 1411V005
Usage
• Hold the disposable protective sheath
firmly at the white edging and pull the
transparent plastic side in the direction of
the camera head�
• Pull the paper lower side from the camera
head in the direction of the handpiece�
Mount light protector
WARNING
Risk of cross contamination
when used without or after
wrong treatment
• Sterilise the light protector before
every use in a steam steriliser (see
"8�2 Prepare light protector")�
• Hold the camera such that the optical ele-
ment is facing down�
• Lift the white edge to the disposable pro-
tective sheath and slide the camera head
carefully into the sheath� The transparent
plastic side must be facing upwards�
• Stretch the protective sheath an extra 2 -
3mm so that the sheath presses tightly
against the optical element�
• Carefully press the protective sheath
against the window of the optical element
with the tips of the fingers� Be careful to
ensure no air bubbles occur between the
window of the optic itself and the protec-
tive sheath�
EN

9000-618-201/30 1411V005 13
Usage
7.2 Using the appliance
CAUTION
Radiated light can damage the
eyes
• Do not peer into the light source�
• Wear polymerisation eye protec-
tion that absorbs UV and blue
light�
CAUTION
The blue light of the polymerisa-
tion lamp is high energy. It can
dazzle and produces heat.
• Only use a polymerisation lamp
with light protection�
• Do not point the polymerisation
lamp at any soft tissue or unpro-
tected skin�
• Observe the exposure times�
• Observe at least 10 seconds
pause between two polymerisa-
tion cycles�
When the appliance is used as a po-
lymerisation lamp, no software and
no connection is required on a com-
puter�
If the Poly interchangeable head is
attached, the imaging software (e�g�
DBSWIN) shows no image (black)�
• Place the light protector from above onto
the interchangeable head� Carefully en-
sure that the light protector itself does not
obscure the optical element of the inter-
changeable head�
EN

14 9000-618-201/30 1411V005
Usage
The polymerisation lamp begins to light
up�
It lights for max� 20 seconds� After every
5 seconds the handpiece vibrates once
and there is an audible signal� After 20
seconds the handpiece vibrates twice
and the appliance automatically switch-
es off�
20 s 2 x +
15 s
10 s
5 s
1 x +
ON
OFF
• Once the exposure time has been at-
tained press the manual capture�
Establish exposure times
The exposure time is dependent on the
dental materials being employed�
Where the distance between the polymeri-
sation lamp and the dental material is great-
er then the exposure time must be extend-
ed�
• Observe the information supplied with the
dental material, if necessary contact the
manufacturer�
Carry out treatment
Wear polymerisation protective
glasses which absorb UV and blue
light�
Observe any information concerning
the dental materials employed�
• Hold the polymerisation lamp with light
protection close to the dental material re-
quiring hardening� Carefully ensure that
the distance between these is as small as
possible but that the light protector itself
does not come into contact with the den-
tal material�
• At one point press the manual capture�
EN

9000-618-201/30 1411V005 15
Usage
8.2 Prepare light protector
Dürr Dental has verified the suitability of the
following instructions for preparing the prod-
uct for further use�
Preparation process:
1�Cleaning and disinfection (automatic or
manual)
2�Sterilisation in steam steriliser
The person responsible for preparation must
ensure that the process and the equipment,
materials, and personnel used achieve the
required results� If there is any deviation
from the validated preparation process, the
person responsible for the preparation is re-
sponsible for the effectiveness of the pro-
cess and for any adverse consequences�
• Carry out validations and routine monitor-
ing of the preparation process�
• Observe any national and local regulations
that apply to the cleaning, disinfection,
sterilisation and storage�
Automatic cleaning and disinfection
Use a cleaning and disinfection de-
vice in accordance with the manu-
facturer's instructions�
• Remove coarse impurities with a dispos-
able disinfectant wipe (e�g� FD350)�
• Place the product in the device in a way
that ensures that it is properly rinsed and
that the water can flow away�
• Carry out the cleaning and disinfection cy-
cle in accordance with the instructions of
the manufacturer�
• Once the cleaning and disinfection cycle
is complete, check the product for any re-
sidual impurities� If necessary, repeat the
cycle�
Manual cleaning and disinfection by
means of a wet chemical procedure
When carrying out manual cleaning
by means of a wet chemical proce-
dure, use a VAH/DGHM-listed disin-
fectant� Observe the instructions of
the manufacturer of the disinfectant�
8 Cleaning and
disinfecting
8.1 Cleaning and disinfecting of
interchangeable head
Use the following cleaning and disinfectant
agents as disinfectant wipes:
9FD 350 Disinfectant wipes
9FD 333 wipes Disinfectant wipes
9FD 322 Quick acting surface disin-
fectant
9FD 333 Quick acting surface disin-
fectant
9FD 366 Disinfectant for sensitive
surfaces
NOTICE
The wrong cleaning and disin-
fection can damage the inter-
changeable head
• Only clean the surface of the inter-
changeable head�
• Never clean the interchangeable
head from inside�
• Only use disinfection and cleaning
agents specifically approved by
Dürr Dental�
• Do not use any aggressive or
abrasive cleaning materials�
• Only clean the interchangeable
head using wipe disinfection�
• Do not clean the interchangeable
head by submerging or spraying in
combination with disinfectant�
• Do not steam sterilise the inter-
changeable head�
• Wipe the surface of the interchangeable
head with a disinfectant wipe (e�g�
FD350)�
Result:
In order to protect the interchangea-
ble head from dirt during storage,
place the interchangeable head in its
storage box after cleaning�
EN

16 9000-618-201/30 1411V005
Usage
9 Function control
9.1 Check light intensity
The light intensity can be checked using a
suitable measuring instrument (e� g� LED
Demetron radiometer)�
• Switch on the polymerisation lamp but
without disposable sheath or light protec-
tion cover�
• Check the light intensity with appropriate
test device�
• If the light intensity is too low
Clean the optical lens and the measuring
instrument and retest, if necessary
change the interchangeable head�
• Remove coarse impurities with a dispos-
able disinfectant wipe (e�g� FD350)�
• Place the product completely immersed in
an instrument disinfection and cleaning
solution (e�g� ID212,ID212 forte, ID213)�
• Once the cleaning and disinfection cycle
is complete, check the product for any re-
sidual impurities� If necessary, repeat the
cycle�
• Rinse the product with water�
• Dry the product with disposable hygienic
wipes or compressed air�
Steam sterilisation
WARNING
Incorrect sterilisation inhibits the
effectiveness, and can damage
the product
• Only use steam sterilisation�
• Observe the process parameters�
• Do not use any other process�
Process parameters
Temperature: 134 °C
Gauge pressure above ambient:
2�16 bar / 0�216 MPa
Working time: 5 min
• Sterilise the parts for sterilisation before
each use in a small steam steriliser ac-
cording to EN13060 and in sterilisation
cycle Type B with subsequent drying�
• Observe the manufacturer's instructions
for the use of the steam steriliser and the
correct placement of the parts for sterili-
sation�
• Observe all national and local guidelines
and regulations concerning the sterilisa-
tion of medical devices�
Storage
• Store the product protected against con-
tamination�
EN

9000-618-201/30 1411V005 17
10 Tips for Operators and Technicians
Repairs above and beyond simple maintenance may only be carried out by a quali-
fied technician or one of our service technicians�
Problem Probable cause Solution
Polymerisation lamp
does not light
Interchangeable head not cor-
rectly in place
• Remove interchangeable
head and try fitting again�
USB-connecting cable or
power unit not connected
• Check cable connections�
Wrong USB-connecting cable
(without power unit) used
• Only use USB-connecting
cable with power unit (see
"3�3 Special accessories")�
Dental material does
not harden
Exposure times too short • Observe exposure times (see
"Establish exposure times")�
Distance between polymerisa-
tion lamp and dental material
too great
• Hold the polymerisation lamp
as close as possible, but
without making contact, to
the dental material�
Optical element dirty or
scratched
• Clean optical element,
change interchangeable
head if necessary�
Disposable protective sheath
mounted incorrectly
• Use disposable protective
sheath correctly (see "7�1
Prepare the unit")�
Dental material employed is
unsuitable
• Only use dental material
which responds to hardening
by light of wavelength
460±10nm�
• Check the use by date and
the storage conditions of the
dental material�
Light intensity too low • Check the light intensity with
appropriate test device�
Appliance does not
switch on or switches
off too soon
Appliance overheating • Wait until the appliance has
sufficiently cooled�
Trouble-shooting
EN