Dentsply Sirona CEREC AF Connect User manual

New as of:
Nouveau depuis: 03.2021
CEREC AF, CEREC AF Connect
CEREC AI, CEREC AI Connect
CEREC AI for Rear
Operating Instructions (valid for Canada)
Notice d’utilisation (valable pour le Canada)
English / Français

Dentsply Sirona
66 37 487 D3652
D3652.201.01.21.09
EnglishFrançais
CEREC AF, CEREC AF Connect,
CEREC AI, CEREC AI Connect,
CEREC AI for Rear
Operating Instructions (valid for Canada)
CEREC AF, CEREC AF Connect,
CEREC AI, CEREC AI Connect,
CEREC AI for Rear
Notice d’utilisation (valable pour le Canada)

New as of:
03.2021
CEREC AF, CEREC AF Connect
CEREC AI, CEREC AI Connect
CEREC AI for Rear
Operating Instructions (valid for Canada)
English

Table of contents Dentsply Sirona
Operating Instructions (valid for Canada)
266 37 487 D3652
D3652.201.01.21.0203.2021
Table of contents
1Dear Customer,....................................................................................................... 5
1.1 Contact data................................................................................................. 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 ................................................................................................ 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 Transporting the camera................................................................ 12
4.1.5 Stability of the unit.......................................................................... 13
4.1.6 Maintenance and repair ................................................................. 13
4.1.7 Modifications to the product........................................................... 13
4.1.8 Accessories.................................................................................... 13
4.2 Safety labels ................................................................................................ 14
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 Data transmission ........................................................................................ 18
5Technical information.............................................................................................. 19
5.1 Technical description ................................................................................... 19
5.2 Technical data.............................................................................................. 20
5.3 Electromagnetic compatibility ...................................................................... 25
5.3.1 Electromagnetic emission.............................................................. 25
5.3.2 Interference immunity .................................................................... 26
5.3.3 Working clearances ....................................................................... 28

Dentsply Sirona
Operating Instructions (valid for Canada)
Table of contents
66 37 487 D3652
D3652.201.01.21.0203.2021 3
English
6Installation and startup............................................................................................ 29
6.1 Transport and unpacking ............................................................................. 29
6.2 Disposal of packaging materials .................................................................. 29
6.3 Major components ....................................................................................... 30
6.4 Scope of supply ........................................................................................... 33
6.5 Commissioning ............................................................................................ 35
6.5.1 Controls and functional elements................................................... 35
6.5.2 Plug connections............................................................................ 39
6.5.3 Switching the units on.................................................................... 42
6.5.4 Switching the units off.................................................................... 44
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 CEREC Omnicam.......................................................................... 57
8.1.2.1 General information...................................................... 57
8.1.2.2 Components of the Omnicam....................................... 58
8.1.2.3 Removing the mirror sleeve.......................................... 58
8.1.2.4 Refitting the mirror sleeve............................................. 58
8.1.2.5 Mirror sleeve reprocessing overview............................ 59
8.1.2.6 Pre-cleaning of the mirror sleeve.................................. 59
8.1.2.7 Wipe disinfection for the camera and mirror sleeve ..... 60
8.1.2.8 High-level disinfection of the mirror sleeve (with HLD
Set)............................................................................... 60

Table of contents Dentsply Sirona
Operating Instructions (valid for Canada)
466 37 487 D3652
D3652.201.01.21.0203.2021
8.1.2.9 High-level disinfection of the mirror sleeve (without
HLD Set)....................................................................... 65
8.1.2.10 Dry heat sterilization of the mirror sleeve ..................... 67
8.2 Calibrating CEREC Omnicam...................................................................... 68
8.3 Color calibration ........................................................................................... 71
9Disposal .................................................................................................................. 75

Dentsply Sirona
Operating Instructions (valid for Canada)
1 Dear Customer,
1.1 Contact data
66 37 487 D3652
D3652.201.01.21.0203.2021 5
English
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 data
Customer Service Center In the event of technical queries, please use our online contact form at
the following address:
http://srvcontact.sirona.com
Manufacturer's address Sirona Dental Systems GmbH
Fabrikstrasse 31
64625 Bensheim
Germany
Tel.: +49(0) 6251/16-0
Fax: +49(0) 6251/16-2591
e-Mail: [email protected]
www.dentsplysirona.com

2 General data
2.1 Structure of the document
Dentsply Sirona
Operating Instructions (valid for Canada)
666 37 487 D3652
D3652.201.01.21.0203.2021
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 instructions for use.
Such information is highlighted as follows:
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.
NOTE
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.
Tip: Information for simplifying work.

Dentsply Sirona
Operating Instructions (valid for Canada)
2 General data
2.2 Legend
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English
2.1.2 Formats and symbols used
The formats and symbols used in this document have the following
meaning:
Prerequisite
1. First action step
2. Second action step
or
➢ Alternative action
Result
➢ Individual action step
Requests 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.
2.2 Legend
20XX
Year of manufacture
Safety labels
Identifies labels/imprints on the unit (see “Safety labels”).
"Hot surface" symbol
Product disposal symbol (see "Disposal [→75]").
Follow the operating instructions.
To ensure safe operation of the unit, the user must follow the operat-
ing instructions.
Symbol for 24 volt DC

2 General data
2.2 Legend
Dentsply Sirona
Operating Instructions (valid for Canada)
866 37 487 D3652
D3652.201.01.21.0203.2021
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

Dentsply Sirona
Operating Instructions (valid for Canada)
3 General description
3.1 Certification
66 37 487 D3652
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English
3General description
3.1 Certification
CE mark
This product bears the CE mark in accordance with the provisions of the
Council Directive 93/42/EEC of June 14, 1993 concerning medical
devices and their changes.
NOTE
CE mark for connected products
Further products which are connected to this unit must also bear the
CE mark.
Compliance
Anyone creating or changing a medical electrical system in accordance
with standard IEC 60601-1:2005 + A1:2012 (+A2:2020) chapter 16
through a combination with other devices is responsible for ensuring
that the requirements of this standard are met to the full extent in order
to ensure the safety of patients, operators and the environment. The
combination with a PC is such a creation of a medical electrical system.

3 General description
3.2 Intended use
Dentsply Sirona
Operating Instructions (valid for Canada)
10 66 37 487 D3652
D3652.201.01.21.0203.2021
3.2 Intended use
In combination with the milling unit, the CEREC AF / CEREC AI /
CEREC AF Connect / CEREC AI Connect / CEREC AI for Rear 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.
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.

Dentsply Sirona
Operating Instructions (valid for Canada)
4 Safety
4.1 Basic safety information
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4Safety
4.1 Basic safety information
4.1.1 Prerequisites
NOTE
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.
NOTE
Restrictions regarding installation site
The system is not intended for operation in areas subject to explosion
hazards.
4.1.2 Connecting the unit
Perform connection by following the directions given in the present
operating instructions.

4 Safety
4.1 Basic safety information
Dentsply Sirona
Operating Instructions (valid for Canada)
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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 /
CEREC AI for Rear is Class B equipment (classified according to
CISPR 11, EN 60601-1-2:2015 based on IEC 60601-1-2:2014).
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.
NOTE
Install only approved software
To prevent interference with the runtime reliability of the program,
only approved software may be installed.
➢ Use version ≥ CEREC SW 5.1 (not for CEREC AF Connect/
CEREC AI Connect)
➢ Use version ≥ Connect SW 5.1.
4.1.4 Transporting the camera
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.
The camera can be detached from the storage cradle for use in
treatment rooms.

Dentsply Sirona
Operating Instructions (valid for Canada)
4 Safety
4.1 Basic safety information
66 37 487 D3652
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4.1.5 Stability of the unit
NOTE
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.
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.

4 Safety
4.2 Safety labels
Dentsply Sirona
Operating Instructions (valid for Canada)
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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 60601-1:2006 + Cor.:2010 + A1:2013,
IEC 60601-1 Edition 3.1:2012,
EN 61010-1:2010 based on IEC 61010-1:2010 + Cor.:2011.
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.
NOTE
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).

Dentsply Sirona
Operating Instructions (valid for Canada)
4 Safety
4.2 Safety labels
66 37 487 D3652
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English
Heater plate
CAUTION
Risk of burns due to hot surface!
➢ Never touch the heater plate (A)!

4 Safety
4.3 Electrostatic charge
Dentsply Sirona
Operating Instructions (valid for Canada)
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4.3 Electrostatic charge
4.3.1 ESD warning labels
ESD warning label 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.
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".