Sirona CEREC MC, CEREC MC X Operating Instructions Manual
New as of:
Operating Instructions (valid for USA)
10.2017
Sirona Dental CAD/CAM System
CEREC MC / MC X
English (US)
=
Operator Manual
This product is covered by one or more of the following US patents:
• US6454629
• US6394880
• US6702649
• US7522764
• US7163443
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Dentsply Sirona
Operating Instructions (valid for USA) Sirona Dental CAD/CAM System
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Dentsply Sirona Table of contents
Operating Instructions (valid for USA) Sirona Dental CAD/CAM System
Table of contents
1
Dear Customer, ....................................................................................................... 7
1.1 Contact information ...................................................................................... 7
2
General data............................................................................................................ 8
2.1 Identification of the danger levels................................................................. 8
2.2 Formats and symbols used .......................................................................... 9
2.3 Note PC / Acquisition Unit............................................................................ 9
3
General description ................................................................................................. 10
3.1 Certification .................................................................................................. 10
3.2 Intended use................................................................................................. 11
3.3 Further use of Sirona Dental CAD/CAM system .......................................... 12
4
Safety ...................................................................................................................... 13
4.1 Basic safety information ............................................................................... 13
4.1.1 Prerequisites ................................................................................... 13
4.1.2 Maintenance and repair................................................................... 13
4.1.3 Modifications to the product ............................................................ 13
4.1.4 Accessories ..................................................................................... 14
4.2 Opening the processing chamber door during the machining process ........ 14
4.3 Wireless phone interference with equipment ............................................... 14
4.4 Disturbance of data transmission................................................................. 14
5
Installation and startup ............................................................................................ 15
5.1 Transport and unpacking.............................................................................. 15
5.2 Disposal of packaging materials................................................................... 15
5.3 Installation site.............................................................................................. 16
5.4 Commissioning............................................................................................. 16
5.4.1 Functional elements ........................................................................ 17
5.4.2 Standard accessories...................................................................... 19
5.4.2.1 Instruments....................................................................... 19
5.4.2.2 Calibration pins................................................................. 19
5.4.2.3 Torque wrench.................................................................. 19
5.4.3 Display description .......................................................................... 21
5.4.4 Illumination of the processing chamber........................................... 21
5.4.5 Using the processing chamber screen............................................ 22
5.4.6 Connecting the bar code reader...................................................... 22
5.4.7 Installation ....................................................................................... 23
5.4.7.1 Connecting to the PC via LAN.......................................... 23
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Table of contents Dentsply Sirona
Operating Instructions (valid for USA) Sirona Dental CAD/CAM System
5.4.7.2 Connecting the unit to the power supply ........................... 23
5.4.7.3 Installing the unit ............................................................... 23
5.4.7.4 Connecting the suction device (optional) .......................... 24
5.4.7.5 Connecting to the PC via WLAN (option).......................... 27
5.4.7.6 Operating several milling and grinding units over one
access point
28
5.4.7.7 Connecting to the PC via the wireless interface (optional) 28
5.4.8 Filling the water tank ........................................................................ 30
5.4.8.1 Water tank MC / MC X ...................................................... 30
5.4.8.2 Water tank CEREC MC XL Basic...................................... 31
5.4.9 Switching the unit ON and OFF ....................................................... 32
5.5 Repacking ..................................................................................................... 33
5.6 Scope of supply............................................................................................. 33
5.7 Storage.......................................................................................................... 34
6
Operation.................................................................................................................. 35
6.1 Configuration (CEREC MC/MC X) ................................................................ 35
6.2 Calibrating the unit ........................................................................................ 36
6.3 Replacing the set screw................................................................................ 39
6.4 Machining process ........................................................................................ 40
6.4.1 Process types................................................................................... 40
6.4.1.1 Grinding............................................................................. 40
6.4.1.2 Milling ................................................................................ 41
6.4.1.3 Permitted instrument combinations................................... 42
6.4.2 Preparations..................................................................................... 42
6.4.3 Starting the machining processes .................................................... 42
6.4.4 Ending the machining processes ..................................................... 43
6.4.5 Information on the seal of approval.................................................. 43
6.5 Entering the bar code.................................................................................... 44
6.6 Manual block clamp ...................................................................................... 45
7
Service ..................................................................................................................... 46
7.1 Using the cleaning hose and the wet cleaning process ................................ 47
7.2 Changing filter bags and HEPA filters........................................................... 48
7.3 Changing the water....................................................................................... 50
7.3.1 General information.......................................................................... 50
7.3.2 Changing the water .......................................................................... 51
7.3.2.1 Water tank MC / MC X ...................................................... 51
7.3.2.2 Water tank CEREC MC XL Basic...................................... 53
7.4 Instruments ................................................................................................... 54
7.4.1 Overview of materials/instruments ................................................... 54
7.4.1.1 CEREC MC ....................................................................... 54
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Dentsply Sirona Table of contents
Operating Instructions (valid for USA) Sirona Dental CAD/CAM System
7.4.1.2 CEREC MC X................................................................... 54
7.4.2 Changing instruments ..................................................................... 54
7.5 Care, cleaning agents, and disinfectants ..................................................... 56
7.6 Cleaning surfaces......................................................................................... 56
7.6.1 Disinfecting...................................................................................... 56
7.6.2 Protection against medicaments ..................................................... 56
7.6.3 Cleaning .......................................................................................... 56
7.7 Replacing the main fuses............................................................................. 57
7.8 Changing the filter ........................................................................................ 58
7.8.1 Water tank MC / MC X .................................................................... 58
7.8.2 Water tank CEREC MC XL Basic.................................................... 59
7.9 Removing water from the unit ...................................................................... 60
7.10 Using the tank cap opener ........................................................................... 61
8
Technical description............................................................................................... 62
8.1 System requirements ................................................................................... 62
8.1.1 CEREC MC ..................................................................................... 62
8.1.2 CEREC MC X.................................................................................. 62
8.2 Grinding and milling unit............................................................................... 62
8.2.1 General technical description.......................................................... 62
8.2.2 Technical data................................................................................. 63
8.2.3 Controller board............................................................................... 63
9
Consumable ............................................................................................................ 64
10
Disposal................................................................................................................... 66
Index........................................................................................................................ 67
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Operating Instructions (valid for USA) Sirona Dental CAD/CAM System
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Dentsply Sirona 1Dear Customer,
Operating Instructions (valid for USA) Sirona Dental CAD/CAM System
1
Dear Customer,
Thank you for your purchase of this CEREC MC/MC X® 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 MC/MC X 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.: +49 (0) 6251/16-0
Fax: +49 (0) 6251/16-2591
e-Mail: contact@dentsplysirona.com
www.dentsplysirona.com
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2General data Dentsply Sirona
2.1Identification of the danger levels Operating Instructions (valid for USA) Sirona Dental CAD/CAM System
2
General 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
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 2General data
Operating Instructions (valid for USA) Sirona Dental CAD/CAM System
2.2
Formats and symbols used
The formats and symbols used in this document have the following
meaning:
2.3
Note PC / Acquisition Unit
When a PC is described in this document, this refers to a PC for the
acquisition unit (if present). The PC is represented symbolically.
Please observe our recommendations for PC configuration (see System
requirements [ → 62]).
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 [ → 9]”
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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3General description Dentsply Sirona
3.1Certification Operating Instructions (valid for USA) Sirona Dental CAD/CAM System
3
General description
3.1
Certification
CE mark
This product bears the CE mark in accordance with the provisions of
Council Directive 2006/42/EC (machinery directive). As such, the
following standards apply: DIN EN ISO 12100:2011-03, DIN EN 610101:2011-07 and DIN EN 61326-1:2013-07.
Examples of CE mark for connected products:
● EN 60601-1:2006 based on IEC 60601-1:2005
● EN 60950-1:2006 based on IEC 60950-1:2005
● UL 60950 second edition 2010
GOST mark
EAC certification
Mark of conformity of the Eurasian Economic Community
CAUTION
CE mark for connected products
Further products which are connected to this unit must also bear the CE
mark. These products must be tested according to the applicable
standards.
24
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Dentsply Sirona 3General description
Operating Instructions (valid for USA) Sirona Dental CAD/CAM System
3.2
Intended use
The Sirona Dental CAD/CAM System is intended for use in partially or
fully edentulous mandibles and maxillae in support of single or multipleunit cement retained restorations. For the SSO 3.5 L and SBL 3.3 L
titanium bases, the indication is restricted to the replacement of single
lateral incisors in the maxilla and lateral and central incisors in the
mandible. 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 implant 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)
● Straumann Bone Level (K053088, K062129, K060958)
● Biomet 3i Certain (K014235, K061629)
● Nobel Biocare Active (K071370)
CAUTION
Small diameter implants and large angled abutments in the anterior
region of the mouth due to possible failure of the implant system.
CAUTION
Federal Law (USA) restricts the sale of this device to or on the order of
a physician, dentist, or licensed practitioner.
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3General description Dentsply Sirona
3.3Further use of Sirona Dental CAD/CAM system Operating Instructions (valid for USA) Sirona Dental CAD/CAM System
3.3
Further use of Sirona Dental CAD/CAM system
The Sirona Dental CAD/CAM System is also:
● an optical impression system for computer assisted design and
manufacturing (CAD/CAM) according to 21 CFR 872.3661. The
system records the topographical characteristics of teeth, dental
impressions, or stone models for use in the computer-assisted design
and manufacturing of dental restorative prosthetic devices.
● an endosseous dental implant accessory according to 21 CFR
872.3980. The system is used to produce a part that the user can
manually incorporate together with other 3rd party components into a
dental surgery guide, a temporary accessory used with endosseous
dental implants with tissue contact for less than 1 hour (exempt).
Such devices are exempt from the premarket notification procedures.
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Dentsply Sirona 4Safety
Operating Instructions (valid for USA) Sirona Dental CAD/CAM System
4
Safety
4.1
Basic safety information
4.1.1 Prerequisites
4.1.2 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.
4.1.3 Modifications to the product
Modifications to this product which may affect the safety of the operator,
patients or third parties are prohibited by law!
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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4Safety Dentsply Sirona
4.2Opening the processing chamber door during the machining process Operating Instructions (valid for USA) Sirona Dental CAD/CAM
4.1.4 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. In particular, only the power cable also
supplied or the corresponding original spare part may be used with the
unit. The user is responsible for any damage resulting from the use of
non-approved accessories.
4.2
Opening the processing chamber door during the
machining process
4.3
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.
4.4
Disturbance of data transmission
Note on wireless communication
Fragment Worldwide
Data communication between the acquisition unit and the CEREC MC/
MC X 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.
Dentsply 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/MC X milling and grinding unit.
CAUTION
Instruments that continue to run
When the processing chamber door is opened during the machining
process, the instruments could continue to run for a short time.
➢ Be careful not to touch the instruments with your hand or any other
object during this time.
➢ Avoid opening the processing chamber door while the milling and
grinding unit is in operation.
➢ Before you open the processing chamber door, end any actions that
are running by pressing the
"Stop"
button on the milling and
grinding unit or in the application software.
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Dentsply Sirona 5Installation and startup
Operating Instructions (valid for USA) Sirona Dental CAD/CAM System
5
Installation and startup
5.1
Transport and unpacking
All products from Dentsply Sirona are carefully checked prior to shipment.
Please perform an incoming inspection immediately after delivery.
1. Check the delivery note to ensure that the consignment is complete.
2. Check whether the product shows any visible signs of damage.
If return shipment is required, please use the original packaging for
shipment.
The unit must be drained prior to shipment (if it has been operated).
Removing water from the unit
Transport without packaging
5.2
Disposal of packaging materials
The packaging must be disposed of in compliance with the relevant
national regulations. Please observe the regulations applicable in your
country.
NOTICE
Damage during transport
If the product was damaged during transport, please contact your
carrying agent.
CAUTION
Damage to the unit or risk of injury during transport without packaging
There is a danger of the unit falling down if it is grasped by its plastic
housing.
➢ The unit should always be carried by two persons.
➢ Do not grasp the unit by its plastic housing.
➢ Always grasp the unit by its chassis next to its feet.
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5.3Installation site Operating Instructions (valid for USA) Sirona Dental CAD/CAM System
5.3
Installation site
The milling and grinding unit requires a level Approx. footprint: 700 x 420
mm (W x D). The height of the milling and grinding unit is:
● with the processing chamber door closed: 425mm
● with the processing chamber door, open: 570mm
Install the milling and grinding unit in such a way that it is not difficult to
operate the main switch.
Make sure that the ventilation slots underneath and at the back of the unit
remain unobstructed. The distance between the back of the unit and the
wall must at least be 10 cm.
Note that the unit weighs 43 kg!
The unit must not be installed at sites with a high level of humidity or dust!
5.4
Commissioning
CAUTION
Install out of the reach of patients!
Do not install or operate the milling and grinding unit in the vicinity of the
patient (place it at least 1.5 m away from the patient).
NOTICE
Installation in a cabinet
If the unit is installed in a cabinet, you must provide for adequate heat
exchange.
The ambient temperature surrounding the unit must be between 5°C
and 40°C.
NOTICE
Important information on initial startup
Observe the software installation instructions!
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Dentsply Sirona 5Installation and startup
Operating Instructions (valid for USA) Sirona Dental CAD/CAM System
5.4.1 Functional elements
Unit overview
Overview of the milling and grinding unit
A Processing chamber D ON/OFF switch
B Processing chamber
door catch
EDrawer
C Display F Water tank
A
B
C D E F
E
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5.4Commissioning Operating Instructions (valid for USA) Sirona Dental CAD/CAM System
Ports on the back side
Connections
Machining room
Machining room
A Main switch
I = ON, 0 = OFF
E Communications interface for
suction
B Fuse cover F Bar code reader connection
C Power connection G Connection for suction
D LAN port
Ethernet
A Instrument set D Workpiece spindle
B Motor mount E Suction connection
C Ceramic block
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Dentsply Sirona 5Installation and startup
Operating Instructions (valid for USA) Sirona Dental CAD/CAM System
5.4.2 Standard accessories
5.4.2.1
Instruments
The following instruments are available for milling and grinding purposes.
When replacing instruments, ensure the permitted instrument
combinations are used (see "Permitted instrument combinations [ → 42]").
5.4.2.2
Calibration pins
The calibration pins are used when calibrating the instrument sets (see
"Calibrating the unit [ → 36]“).
5.4.2.3
Torque wrench
To insert or replace the instruments or calibration pins, use the following
torque wrench.
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5.4Commissioning Operating Instructions (valid for USA) Sirona Dental CAD/CAM System
* All-in-One
Instrument REF Usage Torque wrench Clamping format of
the force
transmission
Step Bur 12 S 6240167 Grinding Triangular
Step Bur 12 6260025 Grinding
Cyl. Pointed Bur 12 S 6240159 Grinding
Step Bur 20 6259597 Grinding
Cyl. Pointed Bur 20 6259589 Grinding
Shaper 25 6299395 Milling
(dry)
Finisher 10 6299387 Milling
Calibration pin (AiO*) 6241132 Calibration
Shaper 25 RZ 6433440 Milling
(wet)
Square
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Dentsply Sirona 5Installation and startup
Operating Instructions (valid for USA) Sirona Dental CAD/CAM System
5.4.3 Display description
These operating instructions describe how to operate the unit by
executing and confirming commands via your PC.
You can also confirm commands such as
"Start" , "Stop" , "Cancel"
or
"OK"
directly on the display of your milling and grinding unit.
Possible commands are then shown above the corresponding button on
the display. In the example shown, button 1, (A) would confirm the
command
"Start"
and button 4, (D) would confirm the command
"Stop"
.
Display
5.4.4 Illumination of the processing chamber
The lighting of the processing chamber depends on the machining
operation involved:
A Button 1 E Command
B Button 2 F Display
C Button 3 G ON/OFF switch
D Button 4
Machining operation Lighting color
Milling and grinding White
Operation completed Green
Error or
"Stop"
button pressed Red
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