Sirona cerec ac User manual

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Operating Instructions for the Acquisition Unit - With CEREC Omnicam

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Table of contents Sirona Dental Systems GmbH
Operating Instructions for the Acquisition Unit
Table of contents
1Dear Customer, ........................................................................................................ 5
1.1 Contact information ....................................................................................... 5
2General data............................................................................................................. 6
2.1 Structure of the document............................................................................. 6
2.1.1 Identification of the danger levels..................................................... 6
2.1.2 Formats and symbols used .............................................................. 7
2.2 Battery warranty ............................................................................................ 7
2.3 Legend .......................................................................................................... 8
3General description .................................................................................................. 10
3.1 Certification ................................................................................................... 10
3.2 Intended use ................................................................................................. 10
4Safety ....................................................................................................................... 11
4.1 Basic safety information ................................................................................ 11
4.1.1 Prerequisites .................................................................................... 11
4.1.2 Connecting the unit .......................................................................... 11
4.1.3 General safety information ............................................................... 12
4.1.4 Movement and stability of the unit.................................................... 12
4.1.5 Maintenance and repair ................................................................... 13
4.1.6 Modifications to the product ............................................................. 13
4.1.7 Accessories...................................................................................... 13
4.1.7.1 Included accessories......................................................... 13
4.2 Safety labels.................................................................................................. 13
4.3 Electrostatic charge....................................................................................... 16
4.3.1 ESD warning labels.......................................................................... 16
4.3.2 ESD protective measures ................................................................ 16
4.3.3 About the physics of electrostatic charges....................................... 17
4.4 Wireless phone interference with equipment ................................................ 18
4.5 Disturbance of data transmission.................................................................. 18
4.6 Integration in a network or connection to a modem ...................................... 19
5Technical information ............................................................................................... 20
5.1 Technical description .................................................................................... 20
5.2 Technical data............................................................................................... 22
5.3 Electromagnetic compatibility........................................................................ 23
5.3.1 Electromagnetic emission ................................................................ 23
5.3.2 Interference immunity....................................................................... 24

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Sirona Dental Systems GmbH Table of contents
Operating Instructions for the Acquisition Unit
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5.3.3 Working clearances......................................................................... 26
6Installation and startup ............................................................................................ 27
6.1 Transport and unpacking.............................................................................. 27
6.2 Disposal of packaging materials................................................................... 27
6.3 Scope of supply............................................................................................ 27
6.4 Initial startup ................................................................................................. 28
6.4.1 Controls and functional elements .................................................... 28
6.4.2 Operating state LED........................................................................ 30
6.4.3 Plug connections ............................................................................. 31
6.4.4 Insert battery (optional) ................................................................... 32
6.4.5 Using a trackball.............................................................................. 32
6.4.6 Changing from right-handed to left-handed operation..................... 33
6.4.7 Switching the units on ..................................................................... 33
6.4.8 Switching the units off ..................................................................... 34
6.5 Battery-backed operation (optional) ............................................................. 35
7Operation................................................................................................................. 38
7.1 Camera warm-up time.................................................................................. 38
7.2 Adjusting the CEREC Omnicam................................................................... 38
7.3 Taking acquisitions with the CEREC Omnicam ........................................... 39
7.4 Directing the camera .................................................................................... 40
7.4.1 Occlusal scan .................................................................................. 41
7.4.2 Buccal scan ..................................................................................... 41
7.4.3 Lingual scan .................................................................................... 42
7.4.4 Approximal surface scan ................................................................. 42
7.4.5 Buccal registration........................................................................... 43
7.4.6 Scan procedure for the color analysis ............................................. 43
7.4.7 Scanning the quadrant and jaw....................................................... 43
7.4.8 Completing measurements ............................................................. 46
7.5 Software for the CEREC Omnicam .............................................................. 46
7.5.1 Cut out model areas ........................................................................ 46
8Maintenance............................................................................................................ 47
8.1 Care, cleaning, disinfection, and sterilization ............................................... 47
8.1.1 Cleaning agents and disinfectants .................................................. 47
8.1.2 Monitor screen................................................................................. 48
8.1.3 Non-critical surfaces with no monitor screen................................... 48
8.1.4 Trackball holder............................................................................... 49
8.1.5 CEREC Omnicam ........................................................................... 49
8.1.5.1 General information.......................................................... 50
8.1.5.2 Components of the Omnicam........................................... 50

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Table of contents Sirona Dental Systems GmbH
Operating Instructions for the Acquisition Unit
8.1.5.3 Removing the mirror sleeve .............................................. 50
8.1.5.4 Refitting the mirror sleeve ................................................. 51
8.1.5.5 Pre-cleaning of the mirror sleeve ...................................... 51
8.1.5.6 Wipe disinfection for the camera and mirror sleeve .......... 51
8.1.5.7 High-level disinfection of the mirror sleeve........................ 52
8.1.5.8 Hot air sterilization of the mirror sleeve ............................. 56
8.2 Calibrating CEREC Omnicam ....................................................................... 57
8.3 Color calibration ............................................................................................ 59
8.4 Replacing the main fuse................................................................................ 62
8.5 Charge battery (optional) .............................................................................. 63
8.6 Replace battery (optional) ............................................................................. 64
9Disposal.................................................................................................................... 65
9.1 Disposal of the storage battery pack............................................................. 66
10 PC Diagnostic Tool................................................................................................... 67
10.1 Start diagnostic tool....................................................................................... 67
10.2 Test procedure .............................................................................................. 68
10.2.1 Customer Diagnostics ...................................................................... 68
10.2.2 Technician Diagnostics .................................................................... 70
10.2.3 Sirona Windows Diagnostics............................................................ 72
10.3 Troubleshooting ............................................................................................ 73
10.3.1 Customer Diagnostics & Technician Diagnostics............................. 74
10.3.2 Sirona Windows Diagnostics............................................................ 76
11 Appendix .................................................................................................................. 77
11.1 DVD playback ............................................................................................... 77
11.2 Making backup copies................................................................................... 77
11.2.1 Creating (burning) a CD ................................................................... 77
11.3 Seal on PC slide-in module........................................................................... 78
Index......................................................................................................................... 79

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Sirona Dental Systems GmbH 1Dear Customer,
Operating Instructions for the Acquisition Unit
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1Dear Customer,
Thank you for your purchase of this CEREC AC® unit 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 therefore read and follow these operating instructions carefully.
Always keep them within easy reach.
Also pay attention to the safety instructions to prevent personal injury and
material damage.
Your
CEREC AC team
1.1 Contact information
Customer service center For technical questions, use the contact form on the internet at the
following address:
http://srvcontact.sirona.com
Manufacturer's address
Sirona Dental Systems GmbH
Fabrikstrasse 31
64625 Bensheim
Germany
Tel.: [phone]
Fax: [phone]
e-Mail: [email protected]
www.dentsplysirona.com

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2General data Sirona Dental Systems GmbH
2.1Structure of the document Operating Instructions for the Acquisition Unit
2General data
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
2.1.1 Identification of the danger levels
To prevent personal injury and material damage, please observe the
warning and safety information provided in these operating instructions.
Such information is highlighted as follows:
Tip: Information for simplifying work.
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 2General data
Operating Instructions for the Acquisition Unit
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2.1.2 Formats and symbols used
The formats and symbols used in this document have the following
meaning:
2.2 Battery warranty
The battery is subject to wear and the warranty period of 6 months
therefore deviates from the period specified for the entire device.
Prerequisite
1. First action step
2. Second action step
or
➢Alternative action
Result
➢Individual action step
Prompts you to do something.
See “Formats and symbols
used [ → 7]”
Identifies a reference to another text
passage and specifies its page
number.
● List Designates a list.
“Command / menu item” Indicates commands, menu items or
quotations.

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2General data Sirona Dental Systems GmbH
2.3Legend Operating Instructions for the Acquisition Unit
2.3 Legend
Year of manufacture
Safety labels
Identifies labels/imprints on the unit (see Safety labels).
Product disposal symbol (see "Disposal [ → 65]").
Storage battery pack disposal symbol (see "Disposal of the storage
battery pack" [ → 66])
Storage battery pack recycling symbol (see "Disposal of the storage
battery pack" [ → 66])
The CEREC AC may contain an RF transmitter in the form of a WLAN
card or a separate wireless module.
Radio approval for Australia/New Zealand
Follow the operating instructions.
To ensure safe operation of the unit, the user must follow the operating
instructions.

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Sirona Dental Systems GmbH 2General data
Operating Instructions for the Acquisition Unit
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Symbols on the packaging
Take note of the following symbols on the packaging:
Top
Protect from moisture
Fragile; handle with care
Temperature during storage and transport
Relative humidity during storage and transport
Air pressure during storage and transport

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3General description Sirona Dental Systems GmbH
3.1Certification Operating Instructions for the Acquisition Unit
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
Anyone creating or changing a medical electrical system through a
combination with other devices in accordance with standard EN 60601-1-
1:2001 based on 60601-1-1:2000 (specification for the safety of medical
electrical systems)/UL 60601-1 Part 1: first edition 2003 is responsible for
ensuring that the requirements of these standards are met to the full
extent in order to ensure the safety of patients, operators and the
environment.
EAC certification
Mark of conformity of the Eurasian Economic Community
3.2 Intended use
In connection with the grinding unit, the CEREC AC acquisition unit is
used to manufacture dental restorations, e.g. from a natural-appearing
ceramic material. The unit may be operated only by medically trained and
qualified personnel.
This unit must not be used for any other purpose. If the unit is used for
any purpose other than the one mentioned above, it may be damaged.
Intended use also includes compliance with these Operating Instructions
and the relevant maintenance instructions.
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.
NOTICE
CE mark for connected products
Further products which are connected to this unit must also bear the CE
mark.
CAUTION
Follow the instructions
If the instructions for operating the unit described in this document are
not observed, the intended protection of the user may be impaired.

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Sirona Dental Systems GmbH 4Safety
Operating Instructions for the Acquisition Unit
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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.
NOTICE
Important information 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.
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!

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4Safety Sirona Dental Systems GmbH
4.1Basic safety information Operating Instructions for the Acquisition Unit
4.1.3 General safety information
4.1.4 Movement and stability of the unit
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 coming into contact with 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 AC acquisition unit is Class B equipment (classified
according to CISPR 11, EN 60601-1-2: 2007 based on IEC 60601-1-
2:2007 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.
➢Use version ≥ CEREC software 4.0.4 or
➢Use version ≥ CEREC Connect software 4.1.1.
NOTICE
Ventilation openings must not be obstructed.
NOTICE
The unit can overturn or slip away
For reasons of tilt stability, the unit must be pulled by its front handle
when being moved. If you push the unit, obstacles on the floor could
block its wheels, thus causing it to overturn.
The two front wheels of the unit have brakes which can be locked to
ensure secure positioning. If the unit is steeply inclined or standing on a
slippery surface and lateral forces are acting on it, it may slide even
though the wheel brakes are locked.
➢Always make sure that the unit's footprint is a flat, nonskid surface.

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Sirona Dental Systems GmbH 4Safety
Operating Instructions for the Acquisition Unit
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4.1.5 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:
● 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.
4.1.6 Modifications to the product
Modifications to this product which may affect the safety of the operator,
patients or third parties are prohibited by law!
4.1.7 Accessories
In order to ensure product safety, this device may be operated only with
original Sirona accessories or third-party accessories expressly approved
by Sirona. The user is responsible for any damage resulting from the use
of non-approved accessories.
4.1.7.1 Included accessories
● Storage battery pack, order no.: 61 87 582
4.2 Safety labels
Fuses
NOTICE
Use ONLY fuses of the same type!

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4Safety Sirona Dental Systems GmbH
4.2Safety labels Operating Instructions for the Acquisition Unit
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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Sirona Dental Systems GmbH 4Safety
Operating Instructions for the Acquisition Unit
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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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4Safety Sirona Dental Systems GmbH
4.3Electrostatic charge Operating Instructions for the Acquisition Unit
4.3 Electrostatic charge
4.3.1 ESD warning labels
ESD warning label
4.3.2 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" [ → 17].
CAUTION
Risk of injury or damage to components from electrostatic discharge
For electrical components labeled with an ESD warning label, observe
the following instructions.
➢Apply the ESD protective measures.
➢Do not touch connector pins or sockets without applying ESD
protective measures first.
➢Do not establish any connections between these connectors without
applying ESD protective measures first.

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Operating Instructions for the Acquisition Unit
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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).
Electrostatic discharge must be preceded by electrostatic charging.
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.
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
4.4Wireless phone interference with equipment Operating Instructions for the Acquisition Unit
4.4 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.
4.5 Disturbance of data transmission
Note on wireless communication Fragment Worldwide
Data communication between the acquisition unit and the CEREC MC XL
milling and grinding unit should preferably be established via the wireless
interface CEREC Radio Device or WLAN.
As for all wireless connections (e.g. cell phones), 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 interface (CEREC Radio Device) or
WLAN, which generally ensures 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
wireless interface connection, and instead connect the LAN cable with the
CEREC MC XL milling and grinding unit.

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Sirona Dental Systems GmbH 4Safety
Operating Instructions for the Acquisition Unit
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4.6 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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5Technical information Sirona Dental Systems GmbH
5.1Technical description Operating Instructions for the Acquisition Unit
5Technical information
5.1 Technical description
CAD system for high-precision intraoral optical impressions
● High-resolution, heated oral camera (3D camera) with removable
reflective sleeve (reflective sleeve sterilizable with hot air)
● Integrated image processing
● High processing power due to state-of-the-art processor
● Trackball
● Hand and foot controlled enter keys
● Wipe-disinfectable membrane keyboard
● Hard disk
● DVD-R(W)/CD-R(W) drive
● Ethernet port
● USB port
● 1 integrated loudspeaker
High-resolution 3D intraoral camera with control and image
processing electronics
Monitor
● 19" TFT LCD flat display, true color, resolution SXGA (1280 x 1024
pixels)
● Measuring technique: Triangulation
● Light source: White LED, unpolarized, visible
spectral range
● Image acquisition: Image control inside the camera
● Image data transfer: Gigabit Ethernet Standard