Sirona cerec ac User manual

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Operating Instructions for th e Acquisition Unit

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Sirona Dental Systems GmbH
Operating Instructions for the Acquisition Unit Sirona Dental CAD/CAM System
Table of contents
1Dear Customer, ........................................................................................................ 5
2General information.................................................................................................. 6
2.1 Structure of the document............................................................................. 6
2.1.1 Identification of danger levels............................................................. 6
2.1.2 Formats and symbols used................................................................ 7
2.2 Warranty........................................................................................................ 7
2.3 Battery warranty ............................................................................................ 7
2.4 Legend .......................................................................................................... 7
3General description .................................................................................................. 8
3.1 Certification ................................................................................................... 8
3.2 Intended 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 Changes to the product...................................................................... 11
4.1.6 Accessories........................................................................................ 11
4.1.6.1Included accessories.......................................................................... 12
4.2 Safety labels.................................................................................................. 12
4.3 Electrostatic charge....................................................................................... 15
4.3.1 ESD warning labels............................................................................ 15
4.3.2 ESD protective measures .................................................................. 15
4.3.3 About the physics of electrostatic charges......................................... 16
4.4 Wireless phone interference with equipment ................................................ 17
4.5 Disturbance of data transmission.................................................................. 17
4.6 Integration in a network or connection to a modem ...................................... 18
5Technical data.......................................................................................................... 19

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Sirona Dental Systems GmbH
Operating Instructions for the Acquisition Unit Sirona Dental CAD/CAM System
6Installation and startup ............................................................................................ 21
6.1 Transport and unpacking.............................................................................. 21
6.2 Disposal of packaging materials................................................................... 21
6.3 Scope of supply............................................................................................ 21
6.4 Initial startup ................................................................................................. 22
6.4.1 Controls and functional elements...................................................... 22
6.4.2 Operating state LED.......................................................................... 25
6.4.3 Line voltage....................................................................................... 25
6.4.4 Plug connections............................................................................... 26
6.4.5 Insert battery (optional) ..................................................................... 27
6.4.6 Using a trackball................................................................................ 28
6.4.7 Changing from right-handed to left-handed operation ...................... 28
6.4.8 Switching the units on ....................................................................... 28
6.4.9 Switching the units off ....................................................................... 30
6.5 Battery-backed operation (optional) ............................................................. 30
7Operation................................................................................................................. 34
7.1 Setting the acquisition system to 3D camera ............................................... 34
7.2 General......................................................................................................... 34
7.3 Preparations ................................................................................................. 35
7.3.1 Surface.............................................................................................. 35
7.3.2 CEREC Optispray ............................................................................. 36
7.3.3 Direction of application...................................................................... 36
7.3.4 Marking the cervical step .................................................................. 36
7.4 Camera support............................................................................................ 37
7.5 Preparing the optical impression .................................................................. 37
7.6 Acquisition control with software version 3.8................................................ 38
7.7 Acquisition control with CEREC SW ............................................................ 40
7.8 Acquiring a 3-unit bridge .............................................................................. 41
8Maintenance............................................................................................................ 42
8.1 Care and cleaning agents ............................................................................ 42
8.2 Care and cleaning of the monitor screen ..................................................... 43
8.3 Surfaces (without monitor) ........................................................................... 43
8.4 Cleaning and setting the trackball cover ring ............................................... 44

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Operating Instructions for the Acquisition Unit Sirona Dental CAD/CAM System
8.5 Calibrating the Bluecam ................................................................................ 44
8.6 Care of the Bluecam ..................................................................................... 47
8.6.1 Prismatic tube without sapphire glass................................................ 47
8.6.2 Prismatic tube with sapphire glass..................................................... 49
8.6.3 Disinfecting the prismatic tube with sapphire glass............................ 51
8.7 Replacing the main fuse................................................................................ 52
8.8 Replacing fuse F3 ......................................................................................... 53
8.9 Charge battery (optional) .............................................................................. 53
8.10 Replace battery (optional) ............................................................................. 54
9Disposal.................................................................................................................... 55
9.1 Disposal of the storage battery pack............................................................. 56
10 Appendix .................................................................................................................. 57
10.1 DVD playback ............................................................................................... 57
10.2 Making backup copies................................................................................... 57
10.2.1 Creating (burning) a CD..................................................................... 57
10.3 Seal on PC slide-in module........................................................................... 58
10.4 PC diagnostics tool ....................................................................................... 58
10.4.1 Starting the diagnostic tool................................................................. 58
10.4.2 Test procedure................................................................................... 60
10.4.2.1Customer Diagnostics ...................................................................... 60
10.4.2.2Technician Diagnostics .................................................................... 61
10.4.2.3Sirona Windows Diagnostics............................................................ 63
10.4.3 Rebooting the PC............................................................................... 64
Index......................................................................................................................... 65

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Sirona Dental Systems GmbH 1Dear Customer,
Operating Instructions for the Acquisition Unit Sirona Dental CAD/CAM System
1Dear Customer,
Dear Customer,
General description
Thank you for purchasing your CEREC AC® 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 Team
Your
CEREC AC Team

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2 General information Sirona Dental Systems GmbH
2.1 Structure of the document Operating Instructions for the Acquisition Unit Sirona Dental CAD/CAM System
2General information
General information
Please read this document completely and follow the instructions exactly.
You should always keep it within reach.
Original language of the present document: German.
2.1 Structure of the document
Structur e of the d ocument
2.1.1 Identification of danger levels
Identificatio n of danger l evels
To prevent personal injury and material damage, please observe the
warning and safety information provided in this document. Such
information is highlighted as follows:
Tip: Information on making work easier.
DANGER
An imminent danger that could result in serious bodily injury or death.
WARNING
A possibly dangerous situation that could result in serious bodily injury
or death.
CAUTION
A possibly dangerous situation that could result in slight bodily injury.
NOTICE
A possibly harmful situation which could lead to damage of the product
or an object in its environment.
IMPORTANT
Application instructions and other important information.

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Sirona Dental Systems GmbH 2General information
Operating Instructions for the Acquisition Unit Sirona Dental CAD/CAM System
2.1.2 Formats and symbols used
Formats and symbols used
The symbols and character formats used in this manual have the
following meaning:
2.2 Warranty
Warranty
To safeguard your warranty claims, please complete the attached
Installation Report / Warranty Passport when the unit is handed over.
Then fax it to the specified fax no.
2.3 Battery warranty
Battery w arranty
The battery is subject to wear and the warranty period of 6 months
therefore deviates from the period specified for the entire device.
2.4 Legend
Legend
Year of manufacture
Safety labels
Safety labels
Identifies labels/imprints on the unit (see Safety labels).
Product disposal symbol
Product disposal symbol (see "Disposal").
Storage battery pack disposal symbol
Storage battery pack disposal symbol (see "Disposal of the storage
battery pack" [ → 56])
Storage battery pack recycling symbol
Storage battery pack recycling symbol (see "Disposal of the storage
battery pack" [ → 56])
✔Prerequisite
1. First action step
2. Second action step
or
➢ Alternative action
Result
Requests you to do something.
See "Formats and symbols
used [ → 7]“
Identifies a reference to another
text passage and specifies its page
number.
● List Identifies a list.
"Command/menu item" Identifies commands, menu items
or quotations.
20XX

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3 General description Sirona Dental Systems GmbH
3.1 Certification Operating Instructions for the Acquisition Unit Sirona Dental CAD/CAM System
3General description
General descript ion
3.1 Certification
Certificat ion
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
Compliance
Any person who assembles or modifies a medical electrical system
complying with the standard EN 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.
NOTICE
CE mark for connected products
Further products which are connected to this unit must also bear the CE
mark.

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Sirona Dental Systems GmbH 3General description
Operating Instructions for the Acquisition Unit Sirona Dental CAD/CAM System
3.2 Intended use
Intended use
Indications for use
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
For the USA only
CAUTION: According to US Federal Law, this product may be sold only
to or by instruction of physicians, dentists, or licensed professionals.
3.3 Further use of Sirona Dental CAD/CAM System
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
4.1 Basic safety information Operating Instructions for the Acquisition Unit Sirona Dental CAD/CAM System
4Safety
Safety
4.1 Basic safety information
Basic safety in formation
4.1.1 Prerequisites
Prerequisites
4.1.2 Connecting the unit
Connecti ng the un it
Description
Perform connection by following the directions given in the present
operating instructions.
4.1.3 General safety information
General safe ty information
NOTICE
Important information on the 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.
NOTICE
Restrictions regarding installation site
The system is not intended for operation in areas subject to explosion
hazards.
NOTICE
Do not damage the unit!
The unit can be damaged if opened improperly.
It is expressly prohibited to open the unit with tools!
CAUTION
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.

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Sirona Dental Systems GmbH 4Safety
Operating Instructions for the Acquisition Unit Sirona Dental CAD/CAM System
4.1.4 Maintenance and repair
Maintena nce 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:
● The Maintenance and repair of this unit may be performed only by
Sirona or by agencies authorized by Sirona.
● Components 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:
● The type and scope of work.
● Any changes made in the rated parameters or working range.
● Date, name of company and signature.
4.1.5 Changes to the product
Changes to the product
Modifications to this unit which may affect the safety of the operator,
patients or third parties are prohibited by law!
4.1.6 Accessories
Accesso ries
In order 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.
CAUTION
Note on the prevention, recognition and elimination of unintended
electromagnetic effects:
The CEREC AC acquisition unit is a Class B unit (classified according
to CISPR 11, EN 60601-1-2: 2006 based on IEC 60601-1-2:2001 and
A1:2004).
This system may be operated in a residential area provided that it is
used under the responsibility of a medical specialist.
NOTICE
Install only approved software
To prevent interference with the runtime reliability of the program, only
approved software may be installed.
NOTICE
Ventilation openings must not be obstructed.

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4.2 Safety labels Operating Instructions for the Acquisition Unit Sirona Dental CAD/CAM System
4.1.6.1 Included accessories
Included accessories
● Camera support (6 pcs), Order No.: 59 45 360
4.2 Safety labels
Safety labels
Fuses
NOTICE
Use ONLY fuses of the same type!

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Sirona Dental Systems GmbH 4Safety
Operating Instructions for the Acquisition Unit Sirona Dental CAD/CAM System
Plug connections of external interfaces
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.
➢Do not touch the pins of the connectors.
NOTICE
The externally connected cables must not be subjected to pulling stress.

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4 Safety Sirona Dental Systems GmbH
4.2 Safety labels Operating Instructions for the Acquisition Unit Sirona Dental CAD/CAM System
Heater plate
CAUTION
In order to maintain electrical safety, the rear doors of the acquisition
unit must be kept closed while it is in operation. The acquisition unit must
not be operated inside of the patient area (within a radius of 1.5 m
surrounding the patient) with the doors open.
CAUTION
Risk of burns due to hot surface!
➢Never touch the heater plate (A)!
A

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Sirona Dental Systems GmbH 4Safety
Operating Instructions for the Acquisition Unit Sirona Dental CAD/CAM System
4.3 Electrostatic charge
Electrostatic c harge
4.3.1 ESD warning labels
ESD warning labels
ESD warning label
Lower warning label
4.3.2 ESD protective measures
ESD protective measures
ESD ESD stands for ElectroStatic Discharge.
ESD protective measures ESD protective measures include:
● Procedures for preventing electrostatic charge build-up (e.g. air
conditioning, air moistening, conductive floor coverings and non-
synthetic clothing)
● Discharging the electrostatic charges of your own body on the frame
of the UNIT, the protective ground wire or large metallic objects
● Connecting yourself to ground using a wrist band.
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" [ → 16].
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
4.3 Electrostatic charge Operating Instructions for the Acquisition Unit Sirona Dental CAD/CAM System
4.3.3 About the physics of electrostatic charges
About the phy sics of electr ostatic 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:
● perceptible at 3,000 V or higher
● audible at 5,000 V or higher (cracking, crackling)
● visible 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 to
implement a wide variety of functions in dental/X-ray/CAD/CAM 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.
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.
NOTICE
Electrostatic discharge must be preceded by electrostatic charging.

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Sirona Dental Systems GmbH 4Safety
Operating Instructions for the Acquisition Unit Sirona Dental CAD/CAM System
4.4 Wireless phone interference with equipment
Wireless phone int erference with equ ipment
The use of mobile wireless phones in practice or hospital environments
must be prohibited to ensure safe operation of the unit.
4.5 Disturbance of data transmission
Disturbanc e of data transm ission
Note on wireless communication Data communication between the acquisition unit and the CEREC MC XL
milling unit should preferably be implemented via the wireless H&W
interface or 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 at
all.
Sirona has selected the best possible configuration for data
communication via the wireless H&W interface or 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. If the only LAN interface on the rear of the
CEREC AC is occupied by another plug, remove this H&W wireless
interface connection and instead connect the LAN cable with the CEREC
MC XL milling unit.

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4.6 Integration in a network or connection to a modem Operating Instructions for the Acquisition Unit Sirona Dental CAD/CAM System
4.6 Integration in a network or connection to a
modem
Integration in a network or connection to a modem
Network
The acquisition unit may only be operated in a network if it is connected
to a HUB/switch. The HUB/switch must:
● be located in the room where the acquisition unit is operated,
permanently installed.
● be 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:
● If a modem is connected, the acquisition unit may only be operated
outside of the patient area (radius of 1.5 m surrounding the patient).
● An RS232 isolator compliant with EN 60 601-1-1 with a dielectric
strength of at least 1.5 kV must be installed at the modem end in the
RS232 connecting cable between the acquisition unit and the
modem.
NOTICE
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:
Cross-section of the protective
ground wire
laid protected 2.5 mm2
laid unprotected 4 mm2

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Sirona Dental Systems GmbH 5Technical data
Operating Instructions for the Acquisition Unit Sirona Dental CAD/CAM System
5Technical data
Technica l data
Technical data WW
Transport and storag e conditions WW+Japa n
Transport and storage conditions
Operating conditions WW+Japan
Operating conditions
Type designation CEREC AC acquisition unit
Rated line voltage for Europe 230 VAC / 50Hz
Rated current for Europe 1.5 A
Rated line voltage for USA 115VAC / 60Hz
Rated current for USA 2.7 A
Rated line voltage for Japan 100VAC / 50Hz and 60Hz
Rated current for Japan 3.0 A
Type of protection against electric shock Class I device
Type of protection against electric shock
(Bluecam)
Type BF applied part
Degree of protection against ingress of
water
Ordinary device (without
protection against ingress
of water)
Operating mode Continuous operation
Battery-backed operation
for 6 minutes
Storage battery pack for battery-backed
operation
24VDC / 2.5Ah
Sirona Order Number:
61 87 582 D3492
Label: CAUTION
Observe accompanying
documents
Temperature -25 ℃ to 60 ℃
(-13° F to 140° F)
Relative humidity 10% to 75%
Air pressure 700 hPa to 1060 hPa
Ambient temperature 10°C to 35°C
(50° F to 95° F)
Relative humidity 30% to 85%
No condensation
Air pressure 700 hPa to 1060 hPa