Dentsply Sirona CEREC AF Connect User manual

New as of:
Nouveau depuis:
Operating Instructions (valid for Canada)
Notice d’utilisation (valable pour le Canada)
10.2017
CEREC AF, CEREC AF Connect
CEREC AI, CEREC AI Connect
English / Français
=

New as of:
Operating Instructions (valid for Canada)
10.2017
CEREC AF, CEREC AF Connect
CEREC AI, CEREC AI Connect
English
=
Operator Manual

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Table of contents Dentsply Sirona
Operating Instructions (valid for Canada) CEREC AF, CEREC AF Connect
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 Legend .......................................................................................................... 7
3General description .................................................................................................. 9
3.1 Certification ................................................................................................... 9
3.2 Intended use ................................................................................................. 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 ............................................................... 11
4.1.4 Transporting the camera .................................................................. 12
4.1.5 Stability of the unit............................................................................ 12
4.1.6 Maintenance and repair ................................................................... 12
4.1.7 Modifications to the product ............................................................. 12
4.1.8 Accessories...................................................................................... 12
4.2 Safety labels.................................................................................................. 13
4.3 Electrostatic charge....................................................................................... 14
4.3.1 ESD warning labels.......................................................................... 14
4.3.2 ESD protective measures ................................................................ 15
4.3.3 About the physics of electrostatic charges....................................... 15
4.4 Wireless phone interference with equipment ................................................ 16
4.5 Data transmission ......................................................................................... 16
5Technical information ............................................................................................... 17
5.1 Technical description .................................................................................... 17
5.2 Technical data............................................................................................... 18
5.3 Electromagnetic compatibility........................................................................ 22
5.3.1 Electromagnetic emission ................................................................ 22
5.3.2 Interference immunity....................................................................... 23
5.3.3 Working clearances.......................................................................... 25

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Dentsply Sirona Table of contents
Operating Instructions (valid for Canada) CEREC AF, CEREC AF Connect
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6Installation and startup ............................................................................................ 26
6.1 Transport and unpacking.............................................................................. 26
6.2 Disposal of packaging materials................................................................... 26
6.3 Major components........................................................................................ 26
6.4 Scope of supply............................................................................................ 28
6.5 Commissioning............................................................................................. 30
6.5.1 Controls and functional elements .................................................... 30
6.5.2 Plug connections............................................................................. 34
6.5.3 Switching the units on ..................................................................... 36
6.5.4 Switching the units off ..................................................................... 38
6.5.5 Tablet operating notes..................................................................... 38
6.5.5.1 Samsung Galaxy Tab S.................................................... 39
6.5.5.2 Dell Venue 10 Pro 5055 ................................................... 40
6.5.5.3 Dell Venue 10 Pro 5056 ................................................... 43
7Operation................................................................................................................. 45
7.1 Camera warm-up time.................................................................................. 45
7.2 Adjusting the CEREC Omnicam................................................................... 45
7.3 Taking acquisitions with the CEREC Omnicam ........................................... 46
7.4 Directing the camera .................................................................................... 48
7.4.1 Occlusal scan.................................................................................. 49
7.4.2 Buccal scan..................................................................................... 49
7.4.3 Lingual scan .................................................................................... 50
7.4.4 Approximal surface scan ................................................................. 50
7.4.5 Buccal registration........................................................................... 51
7.4.6 Scanning the quadrant and jaw....................................................... 51
7.4.7 Completing measurements ............................................................. 54
7.5 Software for the CEREC Omnicam .............................................................. 55
7.5.1 Cut out model areas........................................................................ 55
8Maintenance............................................................................................................ 56
8.1 Care, cleaning, disinfection and sterilization ................................................ 56
8.1.1 Cleaning and disinfection agents .................................................... 56
8.1.2 Tablet .............................................................................................. 56
8.1.3 CEREC Omnicam ........................................................................... 57
8.1.3.1 General information.......................................................... 57
8.1.3.2 Components of the Omnicam........................................... 58
8.1.3.3 Removing the mirror sleeve.............................................. 58
8.1.3.4 Refitting the mirror sleeve................................................. 58
8.1.3.5 Mirror sleeve reprocessing overview................................ 59
8.1.3.6 Pre-cleaning of the mirror sleeve...................................... 59

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Operating Instructions (valid for Canada) CEREC AF, CEREC AF Connect
8.1.3.7 Disinfecting the camera body and mirror sleeve ............... 60
8.1.3.8 High-level disinfection of the mirror sleeve (with HLD Set) 60
8.1.3.9 High-level disinfection of the mirror sleeve (without HLD
Set)
65
8.1.3.10 Dry heat sterilization of the mirror sleeve .......................... 66
8.2 Calibrating CEREC Omnicam ....................................................................... 67
8.3 Color calibration ............................................................................................ 70
9Disposal.................................................................................................................... 73
10 PC Diagnostic Tool................................................................................................... 74
10.1 Start diagnostic tool....................................................................................... 74
10.2 Test procedure .............................................................................................. 75
10.2.1 Customer Diagnostics ...................................................................... 75
10.2.2 Technician Diagnostics .................................................................... 77
10.2.3 Sirona Windows Diagnostics............................................................ 79
10.3 Troubleshooting ............................................................................................ 80
10.3.1 Customer Diagnostics & Technician Diagnostics............................. 81
10.3.2 Sirona Windows Diagnostics............................................................ 83

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Dentsply Sirona 1Dear Customer,
Operating Instructions (valid for Canada) CEREC AF, CEREC AF Connect
båÖäáëÜ
1Dear Customer,
Thank you for your purchase of this CEREC AF® / CEREC AI® (CEREC
Acquisition Flexible/CEREC Acquisition Integrated) and the Connect
variants unit from Dentsply 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 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 Dentsply Sirona
2.1Structure of the document Operating Instructions (valid for Canada) CEREC AF, CEREC AF Connect
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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Dentsply Sirona 2General data
Operating Instructions (valid for Canada) CEREC AF, CEREC AF Connect
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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 Legend
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.
Year of manufacture
Safety labels
Identifies labels/imprints on the unit (see Safety labels).
"Hot surface" symbol
Product disposal symbol (see "Disposal [ → 73]").
Follow the operating instructions.
To ensure safe operation of the unit, the user must follow the operating
instructions.
Symbol for 24 volt DC

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2General data Dentsply Sirona
2.2Legend Operating Instructions (valid for Canada) CEREC AF, CEREC AF Connect
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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Dentsply Sirona 3General description
Operating Instructions (valid for Canada) CEREC AF, CEREC AF Connect
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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.
3.2 Intended use
In combination with the milling unit, the CEREC AF/CEREC AI/CEREC
AF Connect/CEREC AI Connect 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.
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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4Safety Dentsply Sirona
4.1Basic safety information Operating Instructions (valid for Canada) CEREC AF, CEREC AF Connect
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.
WARNING
Electric shock
In order to prevent the risk of an electric shock, this medical device must
only be connected to a supply mains with a ground wire.
NOTICE
Restrictions regarding installation site
The system is not intended for operation in areas subject to explosion
hazards.

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Operating Instructions (valid for Canada) CEREC AF, CEREC AF Connect
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4.1.3 General safety information
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:
CEREC AF/CEREC AI/CEREC AF Connect/CEREC AI Connect 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.
CAUTION
If the unit is damaged, it must be decommissioned immediately and
remain thus until it has been repaired by a certified engineer.
NOTICE
Install only approved software
To prevent interference with the runtime reliability of the program, only
approved software may be installed.
➢User version ≥ CEREC SW 4.4 (not for CEREC AF Connect/
CEREC AI Connect)
➢Use version ≥ Sirona Connect SW 4.4
➢Use version ≥ CEREC Ortho SW 1.1
➢Use version ≥ Splashtop Streamer 2.6.5.4

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4Safety Dentsply Sirona
4.1Basic safety information Operating Instructions (valid for Canada) CEREC AF, CEREC AF Connect
4.1.4 Transporting the camera
The camera can be detached from the storage cradle for use in treatment
rooms.
4.1.5 Stability of the unit
4.1.6 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
Dentsply Sirona or by agencies authorized by Dentsply 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.
4.1.7 Modifications to the product
Modifications to this product which may affect the safety of the operator,
patients or third parties are prohibited by law!
4.1.8 Accessories
In order to ensure product safety, this device may be operated only with
original Dentsply Sirona accessories or third-party accessories expressly
approved by Dentsply Sirona. The user is responsible for any damage
resulting from the use of non-approved accessories.
CAUTION
Trip/fall hazard
When transporting the camera, be aware that you might trip over the
cable and fall. This is particularly the case if the 50cm camera extension
cable is used.
➢When transporting the camera, please ensure that the free cable
ends are coiled.
NOTICE
The CEREC AF/CEREC AF Connect unit could slip and fall off the table
Please ensure that you place the cradle and camera on a flat surface.
The round plate upon which the cradle is mounted is equipped with non-
slip feet to prevent movement.

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Dentsply Sirona 4Safety
Operating Instructions (valid for Canada) CEREC AF, CEREC AF Connect
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4.2 Safety labels
Plug connections of external PC 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 Part 1: 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 coupling box for connecting external
interfaces.
➢Do not touch the pins of the connectors.
NOTICE
The externally connected cables must not be subjected to pulling stress.
CAUTION
Trip/fall hazard
When installing the supply cable (the cable between the coupling box
and the camera storage cradle) there might be a risk of tripping.
➢Lay the cable so that there is no risk of tripping.
➢Attach the supply line so that it remains fixed at all times.
CAUTION
To maintain electrical safety, the PC must not be operated within the
patient area (a radius of 1.5m surrounding the patient).

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4Safety Dentsply Sirona
4.3Electrostatic charge Operating Instructions (valid for Canada) CEREC AF, CEREC AF Connect
Heater plate
4.3 Electrostatic charge
4.3.1 ESD warning labels
CAUTION
Risk of burns due to hot surface!
➢Never touch the heater plate (A)!

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Dentsply Sirona 4Safety
Operating Instructions (valid for Canada) CEREC AF, CEREC AF Connect
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ESD warning label
The ESD warning label must be attached to the coupling box connector
pins.
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".
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).
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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4Safety Dentsply Sirona
4.4Wireless phone interference with equipment Operating Instructions (valid for Canada) CEREC AF, CEREC AF Connect
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.
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 Data transmission
Data communication between the CEREC AF/CEREC AI and the milling
unit should preferably be via LAN cable.

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Dentsply Sirona 5Technical information
Operating Instructions (valid for Canada) CEREC AF, CEREC AF Connect
båÖäáëÜ
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
● Camera storage cradle can be disinfected by wiping.
High-resolution 3D intraoral camera with control and image
processing electronics
PC hardware requirements (V3.4.1)
Special PC with the following equipment:
PC software requirements
● Measuring technique: Triangulation
● Light source: White LED, unpolarized, visible
spectral range
● Image acquisition: Image control inside the camera
● Image data transfer: Gigabit Ethernet Standard
● Processor: Intel i7 5820K
● Memory: 2 x 8GB, 2133MHz DDR4-RAM
● DVD-R(W)/CD-R(W): SH-224 combi drive
● Hard disk: 1TB 2.5” S-ATA SSHD
● Onboard network: Ethernet 10/100/1000MBit/s
● Network card: Ethernet 10/100/1000MBit/s intel
PCIe
● WLAN card: TP-Link TL-WDN4800
● Sound card: Realtek HD Audio onboard
● Graphics card: AMD R9 285
● Operating system: Windows Embedded Standard 7,
64Bit
● Installation: The operating system is installed at
the factory.
During initial start of the PC, the
language selection is made.

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5Technical information Dentsply Sirona
5.2Technical data Operating Instructions (valid for Canada) CEREC AF, CEREC AF Connect
5.2 Technical data
Transport and storage conditions
Operating conditions
Type designation CEREC AF/CEREC AI/
CEREC AF Connect/
CEREC AI Connect
Rated line voltage 100 - 240 VAC /50 - 60 Hz
Rated current 1.0-0.6 A
Type of protection against electric shock Class I device
Type of protection against electric shock
(CEREC Omnicam camera)
Type BF applied part
Degree of protection against ingress of
water
Ordinary device (without
protection against ingress
of water)
Pollution degree 2
Installation category Ⅱ
Operating mode Continuous operation
Label: CAUTION
Observe accompanying
documents
Temperature -25°C to 60°C
(-13°F to 140°F)
Relative humidity 10% to 75%
Air pressure 700 hPa to 1060 hPa
Ambient temperature 10 ℃ to 35 ℃
(50° F to 95° F)
Relative humidity 30% to 85%
No condensation
Air pressure 700 hPa to 1060 hPa
Operating altitude ≤ 3000m