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CEREC Guide 2: Operating Instructions (Not Valid For USA)

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New as of: 10.

2020

CEREC Guide 2

Operating Instructions (not valid for USA)

English
Table of contents Dentsply Sirona
Operating Instructions CEREC Guide 2

Table of contents
1 General data ........................................................................................................... 3
1.1 Contact information...................................................................................... 3
1.2 Structure of the document............................................................................ 3
1.2.1 Identification of the danger levels .................................................. 3
1.2.2 Formats and symbols used............................................................ 4
1.3 Symbols used .............................................................................................. 4
1.4 Intended use ................................................................................................ 5
1.5 Indications.................................................................................................... 5
1.6 Contraindications ......................................................................................... 5

2 Safety instructions .................................................................................................. 6


2.1 Exclusion of liability...................................................................................... 6
2.2 Limitations.................................................................................................... 6
2.3 Prerequisites ................................................................................................ 6
2.4 Alternative SICAT OPTIGUIDE.................................................................... 6

3 Product description ................................................................................................. 7


3.1 Description of the CEREC Guide 2.............................................................. 7
3.2 Materials ...................................................................................................... 9

4 Application .............................................................................................................. 14
4.1 Creating a CEREC Guide 2 ......................................................................... 14
4.1.1 Optical impression ......................................................................... 14
4.1.2 3D x-ray and implant planning ....................................................... 15
4.1.3 Design and development of the CEREC Guide 2 .......................... 17
4.1.4 Application information................................................................... 18
4.2 Cleaning, disinfection and sterilization......................................................... 18
4.2.1 Cleaning and disinfection............................................................... 18
4.2.2 Cleaning the CEREC Guide Drill Keys .......................................... 18
4.2.3 Sterilization of the CEREC Guide Drill Keys .................................. 19
4.3 Surgical intervention .................................................................................... 20

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Dentsply Sirona 1 General data
Operating Instructions CEREC Guide 2 1.1 Contact information

1 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.

1.1 Contact information


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: contact@dentsplysirona.com
www.dentsplysirona.com

1.2 Structure of the document


1.2.1 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.

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1 General data Dentsply Sirona
1.3 Symbols used Operating Instructions CEREC Guide 2

1.2.2 Formats and symbols used


The formats and symbols used in this document have the following
meaning:

 Prerequisite Requests you to do something.


1. First action step
2. Second action step
or
➢ Alternative action
 Result
➢ Individual action step
See "Formats and symbols used  Identifies a reference to another
[→ 4]" text passage and specifies its
page number.
● List Designates a list.
"Command / menu item" Indicates commands / menu
items or quotations.

1.3 Symbols used


Symbol Description
NOTE!  Observe operating instructions!

This product is a medical device in accor-


dance with Council Directive 93/42/EEC.

CAUTION: According to US Federal Law,


this product may be sold only to or by in-
struction of physicians, dentists, or licensed
professionals.
Article number

Batch number

This product is intended for single use only

unsterile
NON
STERILE

Protect against direct sunlight.

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Dentsply Sirona 1 General data
Operating Instructions CEREC Guide 2 1.4 Intended use

1.4 Intended use


CEREC Guide 2 supports dentists and oral surgeons when drilling or
setting tooth implants.

1.5 Indications
The CEREC Guide 2 provides support when drilling or setting tooth
implants.
The CEREC Guide 2 can be used for all tooth positions.

1.6 Contraindications
The use of CEREC Guide 2 is regarded as a contraindication for an
untoothed jaw or for only a single tooth, since secure positioning cannot
be guaranteed here.

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2 Safety instructions Dentsply Sirona
2.1 Exclusion of liability Operating Instructions CEREC Guide 2

2 Safety instructions

2.1 Exclusion of liability


The CEREC Guide 2 surgical guide is an aid that is created by a
qualified dentist or dental technician. The user therefore bears full
responsibility for the shape, suitability and application of the guide.
Observe the processing instructions provided by the implant and drill
manufacturers.

2.2 Limitations
A CEREC Guide 2 can be created by you as a clinician or technician
using a CEREC MC X / MC XL / Primemill milling and grinding unit or
an inLab MC X5. CEREC Guide 2 does not represent a fully automatic
solution. It cannot be equated with a surgical guide that has been
manufactured centrally based on your design.
A CEREC Guide 2 must always be supported by residual teeth. It is not
possible to support the guide through the mucous membrane alone.
When working on a CEREC MC X / MC XL / Primemill milling and
grinding unit, no more than one implant per guide can be created.

2.3 Prerequisites
For creation of the optical impression and for design and export of a
prosthetic proposal:
● CEREC SW 4.3.1 or inLab SW 15.0 incl. implant module
● CEREC only: Open GALILEOS Implant license
For creation of a 3D X-ray volume and for implant planning:
● GALILEOS, ORTHOPHOS XG 3D or ORTHOPHOS SL 3D
● Sidexis XG or Sidexis 4
● Galaxis 1.9.2
● Implant planning software "GALILEOS Implant", V1.9.2, or Sicat
Implant 2.0.1
For preparation of the CEREC Guide 2:
● CEREC SW 4.4 or inLab SW 15.0 incl. implant module
● CEREC only: Open GALILEOS Implant license
● CEREC MC X or CEREC MC XL milling and grinding unit with
milling function, CEREC Primemill or inLab MC X5.

2.4 Alternative SICAT OPTIGUIDE


If uncertainty exists at any time or the situation is deemed to be critical,
the surgery must not be completed under any circumstances.
In such cases an optical impression (CEREC) of the situation must be
imported into the X-ray volume. This can then be used to order a SICAT
OPTIGUIDE; refer to the "GALILEOS Implant" manual Version 1.9 or
higher or the "Sicat Implant" manual.

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Dentsply Sirona 3 Product description
Operating Instructions CEREC Guide 2 3.1 Description of the CEREC Guide 2

3 Product description

3.1 Description of the CEREC Guide 2


CEREC Guide 2 is a precise surgical guide which is individually created
in your practice or laboratory. The manufacturing process is fast and
incurs comparatively low costs.
The individually produced surgical guide is a component of the
integrated implant planning and surgical procedure using CAD/CAM
and 3D X-ray systems from Dentsply Sirona.
A precondition is that the position of one or more implants has been
planned using a 3D X-ray scan (CBCT) and this position is to be
transferred to the actual jaw. CEREC Guide 2 is an aid whose purpose
is to support the dentist when setting implants. CEREC Guide 2
functions as a surgical guide that is placed on the residual teeth or
another supporting structure in the mouth and acts as a mechanical
guide for the drills used. Together with CEREC Guide 2, drill keys are
also used as adapter sleeves, which enable the use of drills with smaller
diameters.
The key steps for production and use of a CEREC Guide 2 are as
follows:
1. Optical scan
An optical scan of the situation in the mouth is created (either
intraoral or using a model). A sufficiently large area is
encompassed, on which the surgical guide can later be supported.
A restoration is designed, which initially enables the subsequent
implant planning in terms of prosthetic aspects.
This information is exported as an *.SSI file for further processing in
GALILEOS Implant. Export as an *.SIXD file must be chosen for
further processing in Sicat Implant 2.0.1.
2. CBCT scan
A CBCT scan is performed, which forms the basis for implant
planning.
3. Implant planning
Optical scan (import of the *.SSI or *SIXD file) and CBCT scan are
superimposed in GALILEOS Implant or Sicat Implant using
distinctive features that are present in both scans (such as the
residual teeth).
The implant planning is performed based on all of this information.
Therefore the position of the guide sleeves of the drills is also
defined in relation to the residual teeth (or other supporting
structures).
The planning data is exported as a *.CMG.DXD file.
4. Producing the surgical guide
After import of the *.CMG.DXD file in CEREC or inLab, a surgical
guide is designed that can be placed on suitable supporting
structures and has an opening at a planned location, through which
the drill is to be fed. The single-piece guide is produced from
PMMA, for example, by milling.

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3 Product description Dentsply Sirona
3.1 Description of the CEREC Guide 2 Operating Instructions CEREC Guide 2

5. Surgery
The surgical guide is placed inside the patient’s mouth. According to
the drilling protocol of the manufacturer of the implant, various holes
must be drilled with drills of different guide diameters. Drill keys that
serve as adapter sleeves for the respective drill diameter are also
used for this.
Through the mechanical guiding of the drill with a prescribed
direction and depth, the treating physician is able to realize the
planned implant.

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Dentsply Sirona 3 Product description
Operating Instructions CEREC Guide 2 3.2 Materials

3.2 Materials
Check all materials prior to their initial use for intactness of packaging
and correctness of contents.

CEREC Guide Blocs and inCoris PMMA guide disc


®
CEREC Guide Blocs are made of clear Plexiglas GS 0F00.
The CEREC Guide Blocs medi and maxi are intended for production of
a CEREC Guide 2. These blocks are processed in a milling operation
on the CEREC MC X / MC XL or CEREC Primemill grinding and milling
units.
The inCoris PMMA guide is intended for production of CEREC Guide 2
and is processed in a milling operation on the inLab MC X5.
All parts are provided unsterilized and are intended for single use only.

Designation REF Contents Notes


CEREC Guide Bloc medi 64 66 564 1x CEREC Guide Bloc medi Length: 55 mm, Width: 40 mm,
Height: 22 mm
CEREC Primemill and CEREC
MC X only
CEREC Guide Bloc maxi 64 47 093 1x CEREC Guide Bloc maxi Length: 85 mm, Width: 40 mm,
Height: 22 mm
CEREC MC XL
inCoris PMMA guide disc 65 51 324 1x inCoris PMMA guide disc 22 Ø 98.5 mm, height 22 mm
22 inLab MC X5 only

Drill key sets


The drill keys provided by the implant manufacturers are not compatible
with
CEREC Guide 2. Use the CEREC Guide Drill Keys in place of the
original drill key from the implant manufacturer.
CEREC Guide Pilot Drill Keys are only suitable for guiding pilot drills.
CEREC Guide Drill Keys Sets also contain additional drill keys to guide
the drills for widening drilled holes. Guided insertion of implants using
CEREC Guide 2 is not supported.
All CEREC Guide Drill Keys are only suitable for use with the following
surgical kits from the respective implant manufacturers.
CEREC Guide drill keys are made of grade 1.4301 stainless steel and
are supplied unsterilized.

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3 Product description Dentsply Sirona
3.2 Materials Operating Instructions CEREC Guide 2

Designation REF Suitable for surgical kit


®
CEREC Guide Pi- 64 62 530 AstraTech: Facilitate , pilot drill only
lot Drill Keys 2.0 Biomet 3i: Navigator®, pilot drill
only
Nobel Biocare:
For the pilot drill only
®
● Branemark System Guided
Surgery Kit
®
● NobelReplace Straight Guided
Surgery Kit
®
● NobelReplace Tapered Guided
Surgery Kit
● NobelActive Guided Surgery Kit
®
CEREC Guide Pi- 64 62 563 Straumann :
lot Drill Keys 2.2 Guided Surgery Kit, pilot drill only
®
Sirona CEREC 63 73 711 Straumann :
Guide Drill Key Guided Surgery Kit
Set ST
*
Sirona CEREC 63 73 943 Nobel Biocare:
Guide Drill Key ®
● Branemark System Guided
Set NB Surgery Kit
®
● NobelReplace Straight Guided
Surgery Kit
● NobelActive Guided Surgery Kit
®
Sirona CEREC 63 73 950 AstraTech: Facilitate
Guide Drill Key
Set AT
®
Sirona CEREC 63 73 968 Biomet 3i: Navigator
Guide Drill Key
Set B
Sirona CEREC 63 73 729 Camlog guided drills**
Guide Drill Key
Set C
*
Noble Biocare: The drills for WP and 6.0 implants are not supported.
**
Drills for 3.3 mm implants are not supported
Each drill key is marked with information on the sleeve diameter and
drill diameter:
● Sizes S, M and L indicate the compatibility with the planned sleeve
diameter.
When planning the sleeve in GALILEOS Implant or Sicat Implant, a
determination is made as to whether the drill key size S, M or L is
used.
● The numerical value specified corresponds to the inside diameter of
the drill key in mm. This value does not correspond to the drill
diameter in all systems.
The following table specifies which original manufacturer drill key
corresponds to the respective drill key from the Sirona drill key set.

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Dentsply Sirona 3 Product description
Operating Instructions CEREC Guide 2 3.2 Materials

Overview of drill keys

Drill set Original key desig- Ø drill = S M L


nation Ø inside tray (Ø ≤3.5) (Ø ≤4.3) (Ø ≤ 5.0)
CEREC Guide Pilot Drill Keys 2.0
The set contains three drill keys
Branemark NP Ø 2 2.0 X X X
System Guided Surgery Kit
NobelReplace
Straight Guided Surgery Kit
NobelReplace
Tapered Guided Surgery Kit
NobelActive
Guided Surgery Kit
Astra Tech Facilitate 2.0
Biomet 3i Navigator 2.0
CEREC Guide Pilot Drill Keys 2.2
The set contains three drill keys
Straumann Ø 2.2 mm 2.2 X X X
CEREC Guide Drill Key Set ST (for Straumann)
The set contains 11 drill keys in 2 sterilized boxes.
Guided drills Ø 2.2 mm 2.2 X X X
Ø 2.8 mm 2.8 X X X
Ø 3.5 mm 3.5 X X X
Ø 4.2 mm 4.2 - X X
CEREC Guide Drill Key Set NB (for Nobel Biocare)
The largest drill diameter for the insertion of WP and 6.0 implants is not supported.
The set contains 25 drive keys in 3 sterilized boxes.

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3 Product description Dentsply Sirona
3.2 Materials Operating Instructions CEREC Guide 2

Drill set Original key desig- Ø drill = S M L


nation Ø inside tray (Ø ≤3.5) (Ø ≤4.3) (Ø ≤ 5.0)
Branemark System Guided NP Ø 2 2.0 X X X
Surgery Kit RP Ø 2
NobelReplace Straight Guided 6/WP Ø 2
Surgery Kit
NP Ø 2.8 2.8 X X X
NobelActive Guided Surgery Kit
RP Ø 2.8
NP Ø 3 3.0 X X X
RP Ø 3
6/WP Ø 3
RP Ø 3.2 3.2 X X X
NP Ø 3.2
RP Ø 3.4 3.4 X X X
RP Ø 3.6 3.6 - X X
6/WP Ø 3.6
6/WP Ø 3.8 3.8 - X X
RP - NP 4.1 - X X
6/WP - NP
6/WP Ø 4.2 4.2 - X X
RP Ø 4.2
6/WP Ø 4.6 4.6 - - X
6/WP Ø 5 5.0 - - X
6/WP - RP
CEREC Guide Drill Key Set AT (for Astra Tech Facilitate)
The set contains 17 drill keys in 2 sterilized boxes.
Facilitate 2.0 2.0 X X X
3.2 3.2 X X X
3.35 3.35 X X X
3.7 3.7 - X X
3.85 3.85 - X X
4.2 4.2 - X X
4.7 4.7 - - X
4.85 4.85 - - X
CEREC Guide Drill Key Set B (for Biomet 3i Navigator)
The set contains 16 drill keys in 2 sterilized boxes.
Navigator 2.0 2.0 X X X
2.75 2.75 X X X
3.0 3.0 X X X
3.25 3.25 X X X
3.85 3.85 - X X
4.25 4.25 - X X

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Dentsply Sirona 3 Product description
Operating Instructions CEREC Guide 2 3.2 Materials

Drill set Original key desig- Ø drill = S M L


nation Ø inside tray (Ø ≤3.5) (Ø ≤4.3) (Ø ≤ 5.0)
CEREC Guide Drill Key Set C (for Camlog)*
The set contains 3 of the same drill keys in 1 sterilized box.
Camlog 4.5 (sleeve) 4.5 - - X
* Not suitable for use for 3.3 mm implants.

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4 Application Dentsply Sirona
4.1 Creating a CEREC Guide 2 Operating Instructions CEREC Guide 2

4 Application

4.1 Creating a CEREC Guide 2


4.1.1 Optical impression
1. Scan the situation in the mouth either intraorally or using a model.
In doing so, scan at least all areas that are intended to later serve
as a support for the CEREC Guide 2. The surface scan is also used
for the overlay with the x-ray volume.

NOTE
Note that the surgical guide cannot be bigger than the scanned area.
Avoid gaps in the scan. Otherwise, no locating surface for the CEREC
Guide 2 can be determined at these points.

2. Design a restoration at the planned implant position. Mark the


emergence profile of the tooth on the gingiva in manual entry mode.
3. Export the data record in *.SIXD or *.SSI format.

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Dentsply Sirona 4 Application
Operating Instructions CEREC Guide 2 4.1 Creating a CEREC Guide 2

4.1.2 3D x-ray and implant planning


A CBCT scan can be performed before or after the optical impression.
Make sure that there are no metal artifacts in the scan, as these may
hinder the overlay of optical data with the x-ray volume or even make it
impossible. Do not scan the patient in terminal occlusal position, but
rather with a slightly open jaw. Remove all removable metal parts in the
opposing jaw (e.g. prosthetics). If possible, record 3/4 of the arch of the
jaw. This increases the likelihood that teeth free from artifacts can be
used for recording the jaw relation.
To produce a CEREC Guide 2, the previously created *.SIXD or *.SSI
data record must be imported into the implant planning software. The
optical surface scan is overlaid with the X-ray volume. This makes it
possible to determine the implant position while also considering the
soft tissue and prosthetic planning.

CAUTION
Check that the optical impression is correctly aligned with the X-ray
data record.

To plan the implant, follow the instructions provided in the user manual
of your implant planning software.
Select Sirona - CEREC Guide Drill Keys as the sleeve system (CEREC
Guide 2, SICAT Surgical Guides). You then have three sleeves
available to choose from, which match the CEREC Guide drill keys S, M
or L respectively.
If, for example, only a pilot hole is to be guided, the selection of size S is
sufficient (apart from Camlog).

Instructions for processing in GALILEOS Implant


Only *.SSI data can be imported in GALILEOS Implant. If more than
one prosthetic proposal is to be considered, multiple *.SSI data records
must be imported. As a general rule, follow the procedure in Appendix
C.2 "Exporting plans for third-party processing using optical
impressions".

Instructions for processing in Sicat Implant


Import scan data, preferably in *.SIXD format because it allows color
and multiple prosthetic proposals to be transferred. It is also possible to
import scan data in *.SSI format. To export, follow the instructions in
Chapter 35 of the user manual for Sicat Implant.

Depth stop
The specification of the depth stop is oriented to the length of the drill
used. The planned position is reached when drilling once the
mechanical stop of the drill reaches the drill key or (if the drill does not
have a stop) the length marking on the drill is lowered to the top side of
the drill key.

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4 Application Dentsply Sirona
4.1 Creating a CEREC Guide 2 Operating Instructions CEREC Guide 2

A Drill D Bone
B CEREC Guide Drill Key E Tooth
C Gingiva F CEREC Guide 2

The depth stop is to be entered in the implant planning software using


the D2 value. The D2 value is defined as the distance from the top side
of the surgical guide to the apical tip of the implant. Because the drill
strikes the 1 mm thick drill key, the D2 value to be set results from the
length of the drill minus one millimeter
(D2 = drill length – 1 mm).
The statement of the D1 value is to be ignored.
After entering the D2 value, the sleeve is visualized above the implant
at the relevant height.

NOTE
When making the selection, ensure that the sleeve does not collide
with neighboring teeth and the drill key and the drill itself can be
introduced without a collision.
Note that selecting a smaller sleeve may limit the use of larger drill
diameters.
The Camlog Guided System is only compatible with sleeve L.

If the representation of the underside of the sleeve cuts the optical scan
shown as a yellow line, this indicates that the position of the drill key is
at least partially subgingival.
Multiple implants and sleeve positions are planned in the same way.
The data can be exported in a file. Export the planning data as a
*.CMG.DXD file.

NOTE
Maintain a minimum distance of at least 2 mm between the implant
and critical anatomic structures (e.g., nerve, roots, sinus).

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Dentsply Sirona 4 Application
Operating Instructions CEREC Guide 2 4.1 Creating a CEREC Guide 2

4.1.3 Design and development of the CEREC Guide 2


By selecting "Import", you can directly load the *.CMG.DXD planning
file.

ADMINISTRATION phase
If the plan contains multiple implants, these will be treated as multiple
separate restorations.
Select the machine type for development. This determines the
possibilities for further processing.

MODEL phase
The original scan is represented, which was also the basis for the
implant planning. All areas that are not to be used as a support for the
CEREC Guide 2 should be cut away. This includes, for example, larger
areas of gingiva outside the planned implant position. Parts of the
residual teeth may also be discarded if they are not required for support.
Note that a longer guide is easier to hold in position with one finger and
ensures a more secure support. This applies to free-end situations in
particular.

DESIGN phase
The position and shape of the sleeve cannot be changed using general
design tools.
If a sleeve is shown in red, parts of it are subgingival. Determine
whether these areas are to be cut away (e.g. to enable the unhindered
placement on a model) or are to be left as they are. They color of the
sleeve then turns green.
Optionally, you can create side access to introduce the drill from the
side. This is only recommended for reasons of stability where required
due to a lack of space.
After calculation of the guide element and, if applicable, orientation in
the block, you have the option of creating viewing windows, through
which you can check the fitting of the guide even during the surgical
intervention.
You can then still adapt the design of the guide by cutting away any
interfering areas.

MANUFACTURE phase
So that the milling operation runs without interruption, ensure where
appropriate that milling tools with a sufficient service life are used, the
water filter has been cleaned and there is sufficient water in the tank.
After milling, ensure that no shavings enter into the tank during the
cleaning process, as these can quickly clog the water filter.

Instructions for users of CEREC MC X and CEREC MC XL:


● If applicable, ensure that you have enabled the "MC XL Milling"
option in the "Configuration".
● We recommend inserting the available spare part "Upper
sieve" (REF 6645886) into the milling machine.

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Dentsply Sirona 1 General data
Operating Instructions CEREC Guide 2 1.1 Contact information

1 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.

1.1 Contact information


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: contact@dentsplysirona.com
www.dentsplysirona.com

1.2 Structure of the document


1.2.1 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.

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Dentsply Sirona 4 Application
Operating Instructions CEREC Guide 2 4.2 Cleaning, disinfection and sterilization

4.2.3 Sterilization of the CEREC Guide Drill Keys


The drill key (A) and terminal strip (B) are supplied unsterilized and
must be steam sterilized using a standard practice sterilization device.
The drill keys must be sterilized before being used in the mouth.
Furthermore, the locally applicable legal regulations and the hygiene
standards applicable for a dental practice must be observed. Only use
the approved sterilization procedures specified below to sterilize the drill
keys. Observe the sterilization parameters.
Steam sterilization can be performed with the fractionated vacuum or
the gravitation method. The sterilization time is 5 minutes at 132°C /
270°F and 15 minutes at 121°C / 250°F. Steam sterilization may be
performed only using devices that comply with EN 13060 or EN 285
standards. Sterilization methods must be validated in compliance with
EN ISO 17664.
Tip:
In order to facilitate handling, following cleaning insert the drill keys into
the terminal strip of the tray, which was provided with the CEREC Guide
Drill Keys Set and sterilize the entire set (see Figure).
The responsibility for the sterility of the drill keys lies with the user. It
must be ensured that only suitable devices, materials and product-
specifically validated methods are used to perform sterilization. It must
be ensured that the methods used have been validated. The equipment
and devices must be properly maintained and serviced at regular
intervals.
The manufacturer (dentist/dental technician/dental assistant) must
inform the user about the required sterilization process before insertion
in the patient's mouth!

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1 General data Dentsply Sirona
1.3 Symbols used Operating Instructions CEREC Guide 2

1.2.2 Formats and symbols used


The formats and symbols used in this document have the following
meaning:

 Prerequisite Requests you to do something.


1. First action step
2. Second action step
or
➢ Alternative action
 Result
➢ Individual action step
See "Formats and symbols used  Identifies a reference to another
[→ 4]" text passage and specifies its
page number.
● List Designates a list.
"Command / menu item" Indicates commands / menu
items or quotations.

1.3 Symbols used


Symbol Description
NOTE!  Observe operating instructions!

This product is a medical device in accor-


dance with Council Directive 93/42/EEC.

CAUTION: According to US Federal Law,


this product may be sold only to or by in-
struction of physicians, dentists, or licensed
professionals.
Article number

Batch number

This product is intended for single use only

unsterile
NON
STERILE

Protect against direct sunlight.

63 91 473 D3587
4 D3587.201.01.13.02    10.2020
We reserve the right to make any alterations which may be required due to technical improvements.

© Sirona Dental Systems GmbH Sprache: englisch Printed in Germany


D3587.201.01.13.02      10.2020 Ä.-Nr.:  129 726

Sirona Dental Systems GmbH

Fabrikstr. 31 Order No   63 91 473 D3587


64625 Bensheim
Germany
www.dentsplysirona.com

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