Operating Instructions Sirona Dental CAD/CAM System
Dear Customer,
1
General description
Dear Customer,
Thank you for purchasing your inLab MC XL® from Sirona.
This device enables you to produce dental restorations, e.g. from ceramic
material with a natural appearance (CEramic REConstruction).
Improper use and handling can create hazards and cause damage.
Please read and follow these operating instructions carefully and always
keep them within easy reach.
To prevent personal injury or material damage, it is important to observe
all safety information.
To safeguard your warranty claims, please complete the attached
Installation Report / Warranty Passport when the system is handed over
and send it to the indicated fax number.
Your Team
Your
inLab MC XL Team
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2 General informationSirona Dental Systems GmbH
15096.1.Rev.001
2.1 Identification of the danger levelsOperating Instructions Sirona Dental CAD/CAM System
General information
2
General information
Please read this document completely and follow the instructions exactly.
You should always keep it within reach.
Original language of the present document: German.
2.1
Identification of the danger levels
Identification of the danger lev els
To prevent personal injury and material damage, please observe the
warning and safety information provided in this document. 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.
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.
Tip: Information on making work easier.
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Sirona Dental Systems GmbH2 General information
15096.1.Rev.001
Operating Instructions Sirona Dental CAD/CAM System
2.2
2.3
Formats and symbols used
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
See "Formats and symbols
used [ → 7]“
● ListDesignates a list.
"Command/menu item"Identifies commands, menu items
Prompts you to do something.
Identifies a reference to another
te x t passag e and spec i fies its p age
number.
or quotations.
Warranty
Warranty
To safeguard your warranty claims, please complete the attached
Installation Report / Warranty Passport when the unit is handed over.
Then fax it to the specified fax no.
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3 General descriptionSirona Dental Systems GmbH
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15096.1.Rev.001
3.1 CertificationOperating Instructions Sirona Dental CAD/CAM System
General description
3
General description
3.1
Certification
Certification
CE mark
This product bears the CE mark in accordance with the provisions of
directives 2006/95/EC (Low Voltage Directive) and 2004/108/EC (EMC
Directive).
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.
Examples EN 60601 + EN 60950 + UL 60950
Examples of CE mark for connected products:
● EN 60601-1:1990 + A1:1993 +A2:1995 based on IEC 60601-1
● EN 60950:1992 + A1: 1993 + A2: 1993 + A3: 1995 + A4: 1997 based
on IEC 60950
● UL 60950 third edition 2000
GOST mark
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Sirona Dental Systems GmbH3 General description
15096.1.Rev.001
Operating Instructions Sirona Dental CAD/CAM System
3.2
Intended use
Indications for use
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 titanium bases SSO 3.5 L and
SBL 3.3 L the indication is restricted for 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 implants systems:
● Nobel Biocare Replace (K020646)
● Nobel Biocare Branemark (K022562)
● Friadent Xive (K013867)
● Biomet 3i Osseotite (K980549)
● Astra Tech Osseospeed (K091239)
● Zimmer Tapered Screw-Vent (K061410)
● Straumann SynOcta (K061176)
● 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 sale of this device to or on the order of a
physician, dentist, or licensed practitioner.
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3.3 Further use of Sirona Dental CAD/CAM SystemOperating Instructions Sirona Dental CAD/CAM System
3.3
Further use of Sirona Dental CAD/CAM System
Further use of Sirona De ntal CAD/CAM Sy stem
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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Sirona Dental Systems GmbH4 Safety
15096.1.Rev.001
Operating Instructions Sirona Dental CAD/CAM System
Safety
4
Safety
4.1
Basic safety information
Basic safety information
4.1.1Prerequisites
Prerequisites
NOTICE
Important information on the building installation
The building installation must be performed by a qualified expert in
compliance with the national regulations. DIN VDE 0100-710 applies in
Germany.
NOTICE
Restrictions regarding installation site
The system is not intended for operation in areas subject to explosion
hazards.
NOTICE
Do not damage the unit!
The unit can be damaged if opened improperly.
It is expressly prohibited to open the unit with tools!
4.1.2Maintenance and repair
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:
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● 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.
4.1.3Changes to the product
Changes to the product
Modifications to this unit which may affect the safety of the operator,
patients or third parties are prohibited by law!
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4.2 Milling chamber door open during the milling operationOperating Instructions Sirona Dental CAD/CAM System
4.1.4Accessories
Accessories
In order to ensure product safety, this product may be operated only with
original Sirona accessories or third-party accessories expressly approved
by Sirona. The user assumes the risk of using non-approved accessories.
4.2
4.3
Milling chamber door open during the milling
operation
Milling chamber door open during the milling operation
CAUTION
Milling instruments that continue to run
When the milling chamber door is opened during the milling operation,
the milling instruments could continue to run for a short time.
➢ Be careful not to touch the milling instruments with your hand or any
other object during this time.
➢ Avoid opening the milling chamber door while the milling unit is in
operation.
➢ Before you open the milling chamber door, end any actions that are
"Stop"
running by selecting the
application software.
key on the milling unit or in the
Wireless phone interference with equipment
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.
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Sirona Dental Systems GmbH5 Installation and startup
15096.1.Rev.001
Operating Instructions Sirona Dental CAD/CAM System
Installation and startup
5
Installation and startup
5.1
Transport and unpacking
Transport and unpacking
Transport and unpacking
All Sirona products 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.
NOTICE
Damage during transport
If the product was damaged during transport, please contact your
carrying agent.
If return shipment is required, please use the original packaging for
shipment.
Before every transport, the unit must be drained prior to shipment (if it has
been operated). See "Removing water from the unit" [ → 47]
Transport without packaging
CAUTION
Damage to the unit or danger of injury during transport without
packaging
5.2
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.
Disposal of packaging materials
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.
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5.3 Installation siteOperating Instructions Sirona Dental CAD/CAM System
5.3
Installation site
Installation site
CAUTION
Install out of the reach of patients!
Do not install or operate the milling unit in the vicinity of the patient
(place it at least 1.5 m away from the patient).
The milling unit requires a level floor space of approx. 700 x 420 mm The
height of the milling unit is:
● with the milling chamber door closed: 425 mm
● with the milling chamber door open: 570mm
Install the milling 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 rear side of the unit and
the room wall must be at least 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!
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.
5.3.1Installation site with low light incidence
Impairment of the scanned result
Installation site with low light incidence
NOTICE
Impairment of the scanned result due to sudden incidence of light.
A sudden, strong incidence of light may falsify the scanned result.
Set the unit up so that the milling chamber is not located directly in the
beam path of an extreme light source and is not exposed to direct
sunlight.
5.4
Initial startup
Initial startup
NOTICE
Important information on initial startup
Observe the software installation instructions!
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Sirona Dental Systems GmbH5 Installation and startup
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15096.1.Rev.001
Operating Instructions Sirona Dental CAD/CAM System
5.4.1Functional elements
Functional elements
Unit overview
Overview of the milling unit
AMilling chamberDON/OFF switch
BMilling chamber
EDrawer
door catch
CDisplayFWater tank
Ports on the back side
Ports on the back side
Ports
AMain switch
I = ON, 0 = OFF
DLAN port
Ethernet
BFuse coverEThis connection is not used
CPower connectionFBarcode reader port
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15096.1.Rev.001
5.4 Initial startupOperating Instructions Sirona Dental CAD/CAM System
Milling chamber
Milling chamber
ABur set 1DCeramic block
BBur set 2EWorkpiece spindle
CMotor mount
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Operating Instructions Sirona Dental CAD/CAM System
5.4.2Display description
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 unit.
Possible commands are then shown above the corresponding button on
the display. In the example shown, button 1, (A) would confirm the
command
and button 4, (D) would confirm the command
"Stop"
.
"Start"
Display
AButton 1ECommand
BButton 2FDisplay
CButton 3GON/OFF switch
DButton 4
5.4.3Lighting of the milling chamber
Lighting of the milling chamber
The lighting of the milling chamber depends on the machining operation
involved:
Machining operationLighting color
Millwhite
Operation completedGreen
Error or
"Stop"
button pressedRed
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