Sirona CEREC 3 User manual

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• US7522764
CEREC 3

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Sirona Dental Systems GmbH
Operating Instructions for the Acquisition Unit CEREC 3 Table of contents
Table of contents
1Dear Customer............................................................ 5
2General information ................................................... 6
2.1 Structure of the documents ............................... 6
2.2 Legend .............................................................. 6
2.3 Warranty ............................................................ 7
3General description.................................................... 8
3.1 Certification ....................................................... 8
3.2 Indications for use ............................................. 9
3.3 Further use of Sirona Dental CAD/CAM System 9
4Safety........................................................................... 10
4.1 Basic safety information .................................... 10
4.1.1 Prerequisites................................................... 10
4.1.2 Connecting the unit......................................... 10
4.1.3 General safety information.............................. 10
4.1.4 Maintenance and repair.................................. 11
4.1.5 Modifications of the unit.................................. 11
4.1.6 Accessories .................................................... 11
4.1.7 SIROCAM 3.................................................... 11
4.2 Safety labels ...................................................... 12
4.3 Electrostatic charges ......................................... 13
4.3.1 ESD warning labels ........................................ 13
4.3.2 ESD protective measures ............................... 14
4.3.3 About the physics of electrostatic charges ..... 14
4.4 Disposal ............................................................. 15
4.4.1 Additional note on disposal............................. 15
4.5 Wireless phone interference with equipment .... 15
4.6 Disturbance of data transmission ...................... 15
4.7 Disturbance of data transmission via radio module
(option) .............................................................. 16
4.8 Integration in a network or connection to a modem 16
5Technical data............................................................. 18
6Installation and startup .............................................. 19
6.1 Transport and unpacking ................................... 19
6.2 Disposal of packaging materials ........................ 19
6.3 Scope of supply ................................................. 19

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Sirona Dental Systems GmbH
Table of contents Operating Instructions for the Acquisition Unit CEREC 3
6.4 Initial startup ...................................................... 20
6.4.1 Controls and functional elements ................... 20
6.4.2 Operating state LED ....................................... 23
6.4.3 Line voltage .................................................... 24
6.4.4 Plug connections ............................................ 24
6.4.5 Changing from right-handed to left-handed operation
25
6.4.6 Switching the units on..................................... 26
6.4.7 Switching the units off..................................... 27
7Operation .................................................................... 28
7.1 Setting the acquisition system to 3D camera .... 28
7.2 General ............................................................. 28
7.3 Preparations ...................................................... 29
7.4 Acquisition control ............................................. 31
7.5 Capturing the optical impression ....................... 32
7.6 Acquisition of a 3-unit bridge ............................. 34
8Maintenance................................................................ 35
8.1 Care and cleaning agents ................................. 35
8.2 Care and cleaning of the monitor ...................... 35
8.3 Surfaces (without monitor) ................................ 36
8.4 Cleaning and setting the trackball cover ring .... 37
8.5 Calibrating the 3D camera ................................ 37
8.6 Care of the 3D camera ...................................... 40
8.7 Replacing the main fuses .................................. 42
9SIROCAM 3 video system (optional) ........................ 43
10 Appendix ..................................................................... 44
10.1 DVD playback ................................................... 44
10.2 Making backup copies ....................................... 44
10.2.1MO drive ......................................................... 44
10.2.2Creating (burning) a CD ................................. 44
10.3 Seal on PC slide-in module ............................... 45
Index............................................................................. 46

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Sirona Dental Systems GmbH 1 Dear Customer
Operating Instructions for the Acquisition Unit CEREC 3
1Dear Customer
Thank you for purchasing your CEREC 3®from Sirona.
This device enables you to produce dental restorations, e.g. from ceramic
material with a natural appearance (CEramic REConstruction).
Improper use and handling can create hazards and cause damage. Please
read and follow these operating instructions carefully and always keep them
within easy reach.
To prevent personal injury or material damage it is important to observe all
safety information.
To safeguard your warranty claims, please complete the attached
Installation Report / Warranty Passport when the system is handed over
and send it to the indicated fax number.
Your
CEREC 3 Team

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2 General information Sirona Dental Systems GmbH
Structure of the documents Operating Instructions for the Acquisition Unit CEREC 3
2General information
Please read these operating instructions completely and follow them exactly.
always keep them within easy reach.
2.1 Structure of the documents
Structure of the documents
The symbols and character formats used in the present manual have the
following meaning:
2.2 Legend
Year of manufa cture
Year of manufacture
CAUTION: Be sure to observe all warnings!
Please observe the warning and safety information provided to prevent
personal injury and material damage. Any such information is highlighted by
a signal word, i.e. WARNING, CAUTION or NOTE.
WARNING:
Identifies warnings where a medium risk of injury to persons exists if they are
not observed.
CAUTION:
Identifies safety information where the following hazards exist if they are not
observed: Slight risk of injury to persons, risk of property damage or damage
to the product.
NOTE: Assistance
Identifies additional information, hints and tips.
9Prerequisite
¾Action
or
¾1., 2., …
ªResult
Requests you to do something.
See chapter on "General
information". [6]
Identifies a reference to another text
passage.
List Identifies a list.
“Text between
quotation marks“
Identifies commands, menu items or
quotations.

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Sirona Dental Systems GmbH 2 General information
Operating Instructions for the Acquisition Unit CEREC 3 Warranty
UPS
No mobile operation with an "uninterruptible power supply" (UPS)
The electrical safety of the acquisition unit can no longer be guaranteed and
its operation is prohibited if one of the following points applies:
zThe acquisition unit is operated with a connected and medically
unapprovedUPS in the patient's surroundings.
zThe acquisition unit is operated without a connected protective ground
wire (e.g. mobile operation via UPS).
Safety label
Safety label
Identifies labels/imprints on the unit (see Safety labels [12]).
Product disposal symbol
Product disposal symbol (see "Disposal" [15]).
2.3 Warranty
To safeguard your warranty claims, please complete the attached Installation
Report / Warranty Passport when the system is handed over. Then fax it to
the specified fax no.

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3 General description Sirona Dental Systems GmbH
Certification Operating Instructions for the Acquisition Unit CEREC 3
3General description
3.1 Certification
CE mark
This product bears the CE mark in accordance with the provisions of Council
Directive 93/42/EEC of June 14, 1993 concerning medical devices.
Compliance
Any person who assembles or modifies a medical electrical system complying
with the standard IEC 60601-1-1:2001 based on IEC 60601-1-1:2000 (safety
requirements for medical electrical equipment) / UL 60601-1 Part 1: first
edition 2003) by combining it with other equipment is responsible for ensuring
that the requirements of this regulation are met to their full extent for the safety
of the patients, the operators and the environment.
GOST mark
CAUTION: CE mark for connected products
Further products which are connected to this unit must also bear the CE
mark.
24

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Sirona Dental Systems GmbH 3 General description
Operating Instructions for the Acquisition Unit CEREC 3 Indications for use
3.2 Indications for use
Intended us e of the AU
The Sirona Dental CAD/CAM System is intended for use in partially
or fully edentulous mandibles and maxillae in support of single or
multiple-unit cement retained restorations. The system consists of
three major parts: TiBase, InCoris mesostructure, and CAD/CAM
software. Specifically, the InCoris mesostructure and TiBase
components make up a two-piece abutment which is used in
conjunction with endosseous dental implants to restore the function
and aesthetics in the oral cavity. The InCoris mesostructure may also
be used in conjunction with the Camlog Titanium base CAD/CAM
(types K2244.xxxx) (K083496) in the Camlog Implant System. The
CAD/CAM software is intended to design and fabricate the InCoris
mesostructure. The InCoris mesostructure and TiBase two-piece
abutment is compatible with the following implants systems:
●Nobel Biocare Replace (K020646)
●Nobel Biocare Branemark (K022562)
●Friadent Xive (K013867)
●Biomet 3i Osseotite (K980549)
●Astra Tech Osseospeed (K091239)
●Zimmer Tapered Screw-Vent (K061410)
●Straumann SynOcta (K061176)
For the USA only
CAUTION: Federal Law (USA) restricts sale of this device to or on the
order of a physician, dentist, or licensed practitioner.
3.3 Further use of Sirona Dental CAD/CAM
System
The Sirona Dental CAD/CAM System is also an optical impression
system for computer assisted design and manufacturing (CAD/CAM)
according to 21 CFR 872.3661.The system records the topographical
characteristics of teeth, dental impressions, or stone models for use in the
computer-assisted design and manufacturing of dental restorative
prosthetic devices. Such devices are exempt from the premarket
notification procedures.

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4 Safety Sirona Dental Systems GmbH
Basic safety information Operating Instructions for the Acquisition Unit CEREC 3
4Safety
4.1 Basic safety information
4.1.1 Prerequisites
4.1.2 Connecting the unit
Perform connection by following the directions given in the present operating
instructions.
Warning on in Eos in connection with ac quisition unit
4.1.3 General safety information
NOTE: Important info on Building installation
The building installation must be performed by a qualified expert in
compliance with the national regulations. DIN VDE 0100-710 applies in
Germany.
NOTE: Restrictions regarding installation site
The system is not intended for operation in areas subject to explosion
hazards.
CAUTION: Do not damage the unit!
The unit can be damaged if opened improperly.
It is expressly prohibited to open the unit with tools!
WARNING:
As long as an inEos is connected to an acquisition unit, no exposures may be
taken in the patient's mouth using the connected CEREC 3D camera.
WARNING: Do not damage the monitor
DO NOT touch the LCD screen with sharp or pointed objects.
If the LCD monitor is damaged (e.g. the glass screen is broken), prevent any
leaking liquid from contacting your skin, mucous membranes (eyes, mouth)
or foodstuffs and be careful not to inhale any escaping vapors.
Rinse any parts of your body or items of clothing already contaminated by the
liquid with ample amounts of water and soap.
CAUTION:
Note on the prevention, recognition and elimination of unintended
electromagnetic effects:
The CEREC 3 acquisition unit is a Class B device (classified according to
CISPR 11, EN 60601-1-2: 2001 based on IEC 60601-1-2).
This system may be operated in a residential area provided that it is used
under the responsibility of a medical specialist.

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Sirona Dental Systems GmbH 4 Safety
Operating Instructions for the Acquisition Unit CEREC 3 Basic safety information
4.1.4 Maintenance and repair
As manufacturers of dental instruments and laboratory equipment, we can
assume responsibility for the safety properties of the unit only if the following
points are observed:
zThe maintenance and repair of this unit may be performed only by Sirona
or by agencies authorized by Sirona.
zComponents which have failed and influence the safety of the unit must be
replaced with original (OEM) spare parts.
Please request a certificate whenever you have such work performed. It
should include:
zThe type and scope of work.
zAny changes made in the rated parameters or working range.
zDate, name of company and signature.
4.1.5 Modifications of the unit
Modifications to this unit which may affect the safety of the operator, patients
or third parties are prohibited by law!
4.1.6 Accessories
To ensure product safety, this product may be operated only with original
Sirona accessories or third-party accessories expressly approved by Sirona.
The user assumes the risk of using non-approved accessories.
Available Accesorry
zCamera support 6 pcs, Order No. 59 45 360.
4.1.7 SIROCAM 3
If a SIROCAM 3 is installed, the safety information provided in the relevant
operating instructions must be observed.
CAUTION: Install only approved software
To prevent interference with the runtime reliability of the program, only
approved software may be installed.
CAUTION:
Ventilation openings must not be obstructed.

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4 Safety Sirona Dental Systems GmbH
Safety labels Operating Instructions for the Acquisition Unit CEREC 3
4.2 Safety labels
Fuses
Plug connections of external interfaces
Safety labels for p lug connections
CAUTION:
Use ONLY fuses of the same type!
CAUTION:
Additional devices connected to external interfaces must be tested according
to the relevant standards, e.g.:
EN 60601-1:1990 + A1:1993 + A2:1995 based on IEC 60601-1, EN 60950-
1:2001 based on IEC 60950-1:2001, EN61010-1:2001 based on IEC 61010-
1:2001, UL 60601-1 Part1: first edition 2003, UL 60950 third edition 2000, UL
3101-1 Part 1 first edition 1993).
They must be installed outside of the patient area (a radius of 1.5m
surrounding the patient.
CAUTION:
Low voltages are applied to the sockets for connecting external interfaces.
¾Do not touch the pins of the connectors.
CAUTION:
The externally connected cables must not be subjected to pulling stress.

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Sirona Dental Systems GmbH 4 Safety
Operating Instructions for the Acquisition Unit CEREC 3 Electrostatic charges
Heater plate
4.3 Electrostatic charges
4.3.1 ESD warning labels
ESD warning label
ESD warning label
TheDentalCompany
A
CAUTION:
Risk of burns due to hot surface!
¾Never touch the heater plate (A)!
CAUTION:
Connector pins or sockets bearing ESD warning labels must not be touched
or interconnected without ESD protective measures.

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4 Safety Sirona Dental Systems GmbH
Electrostatic charges Operating Instructions for the Acquisition Unit CEREC 3
4.3.2 ESD protective measures
ESD ESD stands for ElectroStatic Discharge.
Training We therefore recommend that all persons working with this system be
instructed on the significance of this warning label. Furthermore, they also
should receive training in the physics of electrostatic discharges which can
occur in the practice and the destruction of electronic components which may
result if such components are touched by electrostatically charged USERS.
The content of this training is explained in the Chapter "About the physics of
electrostatic charges" [14].
4.3.3 About the physics of electrostatic charges
What is an electrostatic charge? An electrostatic charge is a voltage field on and in an object (e.g. a human
body) which is protected against conductance to ground potential by a
nonconductive layer (e.g. a shoe sole).
Formation of an electrostatic charge
Electrostatic charges generally build up whenever two bodies are rubbed
against each other, e.g. when walking (shoe soles against the floor) or driving
a vehicle (tires against the street pavement).
Amount of charge The amount of charge depends on several factors:
Thus the charge is higher in an environment with low air humidity than in one
with high air humidity; it is also higher with synthetic materials than with
natural materials (clothing, floor coverings).
The following rule of thumb can be applied to assess the transient voltages
resulting from an electrostatic discharge.
An electrostatic discharge is:
zperceptible at 3,000 V or higher
zaudible at 5,000 V or higher (cracking, crackling)
zvisible at 10,000 V or higher (arc-over)
The transient currents resulting from these discharges have a magnitude of
10 amperes. They are not hazardous for humans because they last for only
several nanoseconds.
Background Integrated circuits (logical circuits and microprocessors) are used in order to
implement a wide variety of functions in dental/X-ray/CEREC systems.
The circuits must be miniaturized to a very high degree in order to include as
many functions as possible on these chips. This leads to structure
thicknesses as low as a few ten thousandths of a millimeter.
NOTE:
Electrostatic discharge must be preceded by electrostatic charging.

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Sirona Dental Systems GmbH 4 Safety
Operating Instructions for the Acquisition Unit CEREC 3 Disposal
It is obvious that integrated circuits which are connected to plugs leading
outside of the unit via cables are sensitive to electrostatic discharge.
Even voltages which are imperceptible to the user can cause breakdown of
the structures, thus leading to a discharge current which melts the chip in the
affected areas. Damage to individual integrated circuits may cause
malfunction or failure of the system.
To prevent this from happening, the ESD warning label next to the plug warns
of this hazard. ESD stands for ElectroStatic Discharge.
4.4 Disposal
Disposal
Disposal
Please observe the disposal regulations applicable in your country.
Within the European Economic Area, this product is subject to Directive 2002/
96/EC as well as the corresponding national laws. This directive requires
environmentally sound recycling/disposal of the product.
The product must not be disposed of as domestic refuse!
Please contact your dealer if final disposal of your product is required.
4.4.1 Additional note on disposal
The PC motherboard contains a lithium battery.
4.5 Wireless phone interference with
equipment
The use of mobile wireless phones in practice or hospital environments must
be prohibited to ensure safe operation of the unit.
4.6 Disturbance of data transmission
Information on wireless communication
Note on wireless communication The data communication between the CEREC 3 acquisition unit and the
CEREC MC XL milling unit should preferably be implemented via WLAN. As
for all wireless connections (e.g. mobile telephones) heavy utilization of the
available radio channels or shielding caused by building installations (e.g.
metal-shielded X-ray enclosures) may impair the quality of the connection.
This may become noticeable through a reduction in range and/or a slower
data transmission rate. In extreme cases, it will be impossible to establish a
wireless connection.

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4 Safety Sirona Dental Systems GmbH
Disturbance of data transmission via radio module (option) Operating Instructions for the Acquisition Unit CEREC 3
Sirona has selected the best possible configuration for data communication
via WLAN, which generally provides perfect functioning of this connection.
However, in individual cases unrestricted wireless data communication may
be impossible for the reasons mentioned above and/or due to local
circumstances. In such cases, a cable LAN connection should be selected to
ensure uninterrupted operation.
4.7 Disturbance of data transmission via
radio module (option)
DECT radio module
Data transmission may be adversely affected in the following cases:
zif more than 6 pairs of radio interfaces are used in one area
zif an E-net mobile phone is used near the radio interface
Höft&Wessel radio module
Data transmission may be adversely affected if more than 8 pairs of radio
interfaces are used in one area.
If the radio module is operated in Norway, please note that it must not be
operated within a radius of 20 km around Ny-Alesund.
4.8 Integration in a network or connection to
a modem
CAUTION: Observe the following installation regulations
The following installation regulations apply to integration of the acquisition
unit in a network or connection of the acquisition unit to a modem:
HUB
CEREC 3
Modem

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Sirona Dental Systems GmbH 4 Safety
Operating Instructions for the Acquisition Unit CEREC 3 Integration in a network or connection to a modem
Network
The acquisition unit may be operated in a network only if it is connected to a
hub/switch. The hub/switch must:
zbe located in the room where the acquisition unit is operated,
permanently installed.
zbe grounded via an additional ground wire.
Modem
At least one of the following specifications must be fulfilled in order to operate
the acquisition unit on a modem:
zIf a modem is connected, the acquisition unit may be operated only
outside of the patient area (radius of 1.5 m surrounding the patient).
zAn RS232 isolator must be installed at the modem end in the connecting
cable between the acquisition unit and the modem as a separator
according to EN 60 601-1-1 with a dielectric strength of at least 1.5 kV.
Cross-section of the protective
ground wire
laid protected 2.5 mm2
laid unprotected 4mm2

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5 Technical data Sirona Dental Systems GmbH
Operating Instructions for the Acquisition Unit CEREC 3
5Technical data
Type designation CEREC 3 Acquisition unit
Rated line voltage for Europe 230 VAC / 50Hz
Rated current for Europe 1.3 A
Rated line voltage for the USA 115VAC / 60Hz
Rated current for the USA 3.0 A
Rated line voltage for Japan 100VAC / 50Hz u. 60Hz
Rated current for Japan 3.0 A
Type of protection against electric shock Unit classified as Protection
class I
Type of protection against electric shock (3D
camera, SIROCAM camera)
Type BF applied part
Degree of protection against ingress of
water
Ordinary device (without
protection against ingress of
water)
Ambient temperature 10°C to 35°C
Mode of operation Continuous operation
Dimensions (WxHxD) in mm 418 x 1110 x 570
Sign: CAUTION
Observe accompanying
documents
Weight
Without monitor approx.
Monitor approx.
36 kg
4 kg

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Sirona Dental Systems GmbH 6 Installation and startup
Operating Instructions for the Acquisition Unit CEREC 3 Transport and unpacking
6Installation and startup
6.1 Transport and unpacking
Transport and unpacking
All products from Sirona are carefully checked prior to shipment. Please
perform the incoming inspection immediately after delivery.
1Check the delivery note to ensure that the consignment is complete.
2Check whether the product shows any visible signs of damage.
If return shipment is required, please use the original packaging for shipment.
To prevent damage to the LCD monitor, it must be removed during transport
of the unit.
To prevent damage to the heater and the holder, these parts must be
protected against damage during transport (see protective packaging).
6.2 Disposal of packaging materials
The packaging must be disposed of in compliance with the relevant national
regulations. Please observe the regulations applicable in your country.
6.3 Scope of supply
The exact scope of supply is specified in the document "Scope of supply of
the CEREC 3 acquisition unit".
NOTE: Damage during transport
If the product was damaged during transport, please contact your carrying
agent.

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6 Installation and startup Sirona Dental Systems GmbH
Initial startup Operating Instructions for the Acquisition Unit CEREC 3
6.4 Initial startup
6.4.1 Controls and functional elements
Overview of the front panel
A Monitor ON/OFF switch H Foot switch/foot pedal
B Operating state LED I Locking brake
C ON button J Left trackball button
D Membrane keyboard K Trackball
E CEREC 3D camera L SIROCAM 3 (option)
F Heater plate for prismatic
tube
M LEDs without function
G Right trackball button N Keys for monitor settings
The Dental Company
E
C
D
F
G
H
I
A
B
L
M
N
J
K