Dentsply Sirona Cerec Guide 2 User manual

New as of: 12.2018
Sirona Dental CAD/CAM System
CEREC Guide 2
Operating Instructions (valid for USA)
English

Table of contents Dentsply Sirona
Operating Instructions CEREC Guide 2
263 96 100 D3587
D3587.201.01.11.0212.2018
Table of contents
1General 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 Indications for use........................................................................................ 5
1.5 Indications.................................................................................................... 7
2Safety instructions .................................................................................................. 8
2.1 Exclusion of liability...................................................................................... 8
2.2 Limitations.................................................................................................... 8
2.3 Prerequisites ................................................................................................ 8
2.4 Alternative SICAT OPTIGUIDE.................................................................... 8
3Product description ................................................................................................. 9
3.1 Description of the CEREC Guide 2.............................................................. 9
3.2 Materials ...................................................................................................... 11
4Application .............................................................................................................. 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

Dentsply Sirona
Operating Instructions CEREC Guide 2
1 General data
1.1 Contact information
63 96 100 D3587
D3587.201.01.11.0212.2018 3
1General 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 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: [email protected]
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 operating instructions.
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.

1 General data
1.3 Symbols used
Dentsply Sirona
Operating Instructions CEREC Guide 2
4
1.2.2 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
Prompts you to do something.
See "Formats and symbols used
[→4]"
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.
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
NON
STERILE
unsterile
Protect against direct sunlight.

Dentsply Sirona
Operating Instructions CEREC Guide 2
1 General data
1.4 Indications for use
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1.4 Indications for use
The Sirona Dental CAD/CAM System with CEREC SW Chairside
Software is intended for use in partially or fully edentulous mandibles
and maxillae in support of single or multiple-unit cement retained
restorations. For the BH 3.0 S, 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 and CEREC Guides. CEREC Guides support the dentist
or oral surgeon when drilling or setting dental implants. The inCoris
mesostructure and TiBase two-piece abutment is compatible with the
following implant systems:
Manufacturer Name of Implant
System
Implant Size
Platform Diameter
Nobel Biocare Replace NP 3.5
RP 4.3
WP 5.0
6.0 6.0
Active NP 3.5
RP 4.3/5.0
Branemark NP 3.3
RP 3.75/4.0
Straumann Synocta NN (3.5mm) 3.3
RN (4.8mm) 3.3/4.1/4.8
WN (6.5mm) 4.8
Bone Level NC (3.3mm) 3.3
RC (4.1mm/4.8mm 4.1/4.8

1 General data
1.4 Indications for use
Dentsply Sirona
Operating Instructions CEREC Guide 2
6
Manufacturer Name of Implant
System
Implant Size
Platform Diameter
Dentsply Sirona
Implants
Osseospeed 3.5/4.0 3.5 S / 4.0 S
4.5/5.0 4.5/5.0/5.0 S
Xive 3.4 3.4
3.8 3.8
4.5 4.5
5.5 5.5
Osseospeed EV 3.6 3.6
4.2 4.2
4.8 4.8
5.4 5.4
Ankylos C/X A, B, C, D
Biomet 3i Osseotite 3.4 3.25
4.1 3.75
4.1
3/4
5.0 5.0
4/5
Certain 3.4 3.25
4/3
3/4/3
4.1 4.0
4/5/4
5/4
5.0 5.0
4/5
Zimmer Tapered Screw-Vent 3.5 3.7/4.1
4.5 4.7
5.7 6
Thommen Medical SPI ELEMENT, SPI
ELEMENT INICELL, SPI
CONTACT INICELL
3.5 3.5
4 4
4.5 4.5
5 5
6 6
Osstem/Hiossen Osstem TS Implant System
Hiossen Implant System
Mini 3.5
Regular 4.0/4.5/5.0/6.0/7.0

Dentsply Sirona
Operating Instructions CEREC Guide 2
1 General data
1.5 Indications
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Manufacturer Name of Implant
System
Implant Size
Platform Diameter
BioHorizons
(Internal
Connection)
Tapered 3.0,
Tapered plus
3.0 3.0/3.4/3.8
Tapered internal 3.0
Tapered plus 3.5 4.6
Tapered internal,
Tapered internal tissue level
3.0/3.8
Internal dental implant 3.5
Single stage dental implants 3.5/4.0
Tapered plus 4.5 5.8
Tapered internal,
Tapered internal tissue level
4.6
Internal dental implant 4.0
Single stage dental implants 4.0/5.0
Tapered internal,
Tapered internal tissue level
5.7 5.8
Internal dental implant,
Single stage dental implants
5.0/6.0
1.5 Indications
The CEREC Guide 2 is used for dental implants that are completed with
supported and managed surgical systems (refer to “Materials [→11]”).

2 Safety instructions
2.1 Exclusion of liability
Dentsply Sirona
Operating Instructions CEREC Guide 2
8
2Safety instructions
2.1 Exclusion of liability
The CEREC Guide surgical guide is an auxiliary device that is
manufactured by a qualified dentist or dental technician. The user
therefore bears full responsibility for the shape, suitability, and
application of the template.
Observe the processing instructions provided by the implant and drill
manufacturers.
2.2 Limitations
A CEREC Guide 2 can be manufactured by you as a clinician or
technician by means of an MC X / MC XL milling and grinding unit or an
inLab MC X5. The CERECGuide 2 is not a fully automatic solution. It
cannot be compared to a surgical guide that has been manufactured
centrally based on your design.
A CERED Guide 2 must always be supported by the residual teeth. It is
not possible to support the guide through the mucous membrane alone.
When working on a MC X or MC XL milling and grinding unit, no more
than one implant can be created per template.
2.3 Prerequisites
To create the optical impression and export a prosthetic proposal:
● CEREC SW ≥ 4.3.1 or inLab SW ≥ 15.0 incl. implant module
● CEREC only: Open GALILEOS Implant license
To create 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
To develop the CEREC Guide 2:
● CEREC SW ≥ 4.6.1 or inLab SW ≥ 18.1 incl. implant module
● CEREC only: Open GALILEOS Implant license
● MC X milling and grinding unit or MC XL with milling function or
inLab MC X5.
2.4 Alternative SICAT OPTIGUIDE
If there is any uncertainty 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 from version 1.9.

Dentsply Sirona
Operating Instructions CEREC Guide 2
3 Product description
3.1 Description of the CEREC Guide 2
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3Product 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 part of the integrated implant
plan and surgical implementation using CAD/CAM and 3D X-ray
systems from Dentsply Sirona.
It is a prerequisite that the location of one or more implants has been
planned using the 3D X-ray scan (DVT) and that location is to be
transferred to the actual jaw. CEREC Guide 2 is a device that supports
the dentist when setting implants. CEREC Guide 2 functions as a
surgical guide, which 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 reducing bushes, which enable the use of drills with smaller
diameters.
The key steps for manufacturing and using 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 suitably large area is encompassed,
on which the drilling template can later support itself.
A restoration is designed, which initially enables the subsequent
implant planning in terms of prosthetic aspects.
This information is exported as a *.SSI file.
2. DVT exposure
A DVT scan is performed, which forms the basis for the implant
planning.
3. Implant planning
Optical scan (Import of the *.SSI file) and DVT scan are
superimposed in GALILEOS Implant using striking features, which
are present in both scans (such as the residual teeth).
The implant planning is performed based on all of this information.
Therefore the location of the guide bushing of the drill is also
defined in relation to the residual teeth (or other supporting
structures).
The planning data is exported as a *.CMG.DXD file.
4. Creating the drilling template
After importing the *.CMG.DXD file in CEREC or inLab, a drilling
template is designed, which 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 template is create from
PMMA, for example by milling.
5. Surgery
The drilling template is placed in the patient’s mouth. According to
the drilling protocol of the manufacturer of the implant, different
bores with drills with different guide diameters. Drill keys are used
for this and serve as reducing bushes for the respective drill
diameter.

3 Product description
3.1 Description of the CEREC Guide 2
Dentsply Sirona
Operating Instructions CEREC Guide 2
10
The mechanical guide of the drill, with a prescribed direction and
depth, enables the treating physician to change the planned implant
into reality.

Dentsply Sirona
Operating Instructions CEREC Guide 2
3 Product description
3.2 Materials
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3.2 Materials
Check all materials prior to their initial use for intactness of packaging
and correctness of contents.
CEREC Guide Blocs
CEREC Guide Blocs are made of clear Plexiglas® GS 0F00.
The CEREC Guide Blocs medi / maxi and inCoris PMMA guide disc 22
are intended to manufacture a CEREC Guide 2. These materials are
processed in a milling process on the machinery provided for this.
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
MC X only
CEREC Guide Bloc maxi 64 47
093
1x CEREC Guide Bloc maxi Length: 85 mm, Width: 40 mm,
Height: 22 mm
MC XL only
inCoris PMMA guide disc 22 65 51
324
1x inCoris PMMA guide disc 22 Ø 98.5 mm, height 22 mm
only inLab MC X5

3 Product description
3.2 Materials
Dentsply Sirona
Operating Instructions CEREC Guide 2
12
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.
Designation REF Suitable for surgical kit
CEREC Guide Pi-
lot Drill Keys 2.0
64 62 530 AstraTech: Facilitate®, pilot drill only
Biomet 3i: Navigator®, pilot drill
only
CEREC Guide Pi-
lot Drill Keys 2.2
64 62 563 Straumann®:
Guided Surgery Kit, pilot drill only
Sirona CEREC
Guide Drill Key
Set ST
6373711 Straumann®:
Guided Surgery Kit
Sirona CEREC
Guide Drill Key
Set AT
63 73 950 AstraTech: Facilitate®
Sirona CEREC
Guide Drill Key
Set B
63 73 968 Biomet 3i: Navigator®
Sirona CEREC
Guide Drill Key
Set C
63 73 729 Camlog guided drills*
* drills for 3.3 mm implants are not supported
Each drill key is marked with the information for the sleeve diameter and
drill diameter:
● Sizes S, M and L state the compatibility with the planned sleeve
diameter.
When planning the sleeve in GALILEOS 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.

Dentsply Sirona
Operating Instructions CEREC Guide 2
3 Product description
3.2 Materials
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D3587.201.01.11.0212.2018 13
Overview of drill keys
Drill set Original key desig-
nation
Ø drill =
Ø inside tray
S
(Ø ≤3.5)
M
(Ø ≤4.3)
L
(Ø ≤ 5.0)
CEREC Guide Pilot Drill Keys 2.0
The set contains three drill keys
Astra Tech Facilitate 2.0 2.0 X X X
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 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
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.

4 Application
4.1 Creating a CEREC Guide 2
Dentsply Sirona
Operating Instructions CEREC Guide 2
14
4Application
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.
The following applies at least to all areas which are intended to later
serve as a support for the CEREC Guide 2. The surface scan is
also used for the overlay of the x-ray volume.
NOTE
Note that the drilling template cannot be bigger than the scanned
area.
Avoid holes 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 using in *.SSI format.

Dentsply Sirona
Operating Instructions CEREC Guide 2
4 Application
4.1 Creating a CEREC Guide 2
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4.1.2 3D x-ray and implant planning
A DVT exposure 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 at the final bite
position, but rather with a slightly opened 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 likeliness that teeth free from
artifacts can be used for registration.
To produce a CEREC Guide 2, the import of the previously created
*.SSI data record in GALILEOS Implant is necessary. The optical
surface scan is superimposed over the X-ray volume. This makes it
possible to determine the implant location while also considering the
soft tissue and prosthetic planning.
CAUTION
Check that the optical impression is correctly aligned with the X-ray
data record.
If multiple implants are to be planned, multiple *.SSI data records must
be imported.
To plan the implant follow the instructions provided in the "GALILEOS
Implant 1.9.2" operator's manual. As a general rule, follow the
instructions provided in Appendix C.2 "Exporting plans for third-party
processing using optical impressions".
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 one pilot hole is to be created, the selection of size
S is sufficient (apart from Camlog).
The specification of a depth stop is oriented on 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 upper side
of the drill key.

4 Application
4.1 Creating a CEREC Guide 2
Dentsply Sirona
Operating Instructions CEREC Guide 2
16
A Drill D Bones
B CEREC Guide Drill Key E Tooth
C Gingiva F CEREC Guide 2
In the GALILEOS Implant software, the depth stop is to be entered
using the D2 value. The D2 value is defined as the distance from the
side of the drilling template to the apical top of the implant. As 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 selecting the bushing, ensure that it 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 scan shown
as the 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. It
is possible to export this as a file. Export the plan for “processing by
third-party providers by way of optical impressions” as a .CMD.DXD file.
NOTE
Maintain a minimum distance of at least 2 mm between the implant
and critical anatomic structures (e.g., nerve, roots, sinus).

Dentsply Sirona
Operating Instructions CEREC Guide 2
4 Application
4.1 Creating a CEREC Guide 2
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4.1.3 Design and development of the CEREC Guide 2
By selecting "Import" , you can switch the directly load the *.CMG.DXD
file.
Phase ADMINISTRATION
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.
Phase MODEL
If the original scan is presented, which was also the basis for the
implant planning. All areas, which are not intended to serve as a
support for the CEREC Guide 2 should be cut. 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 template is easier to hold in position with one finger
and ensures secure support. This applies to free-end situations in
particular.
Phase DESIGN
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 calculating the template element and if necessary orienting it in the
block, you have the option of creating viewing panels, which you can
use to check the fitting of the template even during the surgical
intervention.
You can then still adapt the design of the template by cutting away any
problematic areas.
Phase MANUFACTURE
Where necessary, ensure that you have activated "Configuration" the
option "MC XL Milling" .
So that the milling process runs without interruption, ensure where
necessary 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.

4 Application
4.2 Cleaning, disinfection and sterilization
Dentsply Sirona
Operating Instructions CEREC Guide 2
18
4.1.4 Application information
● All materials that are used intraorally must be disinfected before use
and safeguarded against aspiration when being used.
● The materials “CEREC Guide Blocs” (see “Materials [→11]”) are
intended for single use only and are not supplied in sterile
packaging; also refer to “Cleaning, disinfection and sterilization
[→18]”.
NOTE
Risk of deformation to the surgical guide
Please protect the drilling template from direct sunlight and high
temperatures
(>35 °C/95 °F) and high humidity (> 80%) to prevent it from
deforming. Check the surgical guide before the operation. Do not use
any heat-based methods to disinfect or sterilize (e.g. autoclaves), as
this can cause the surgical guide to deform.
4.2 Cleaning, disinfection and sterilization
4.2.1 Cleaning and disinfection
CEREC Guide 2 must be cleaned and disinfected prior to clinical use.
Cleaning
Follow the steps below for cleaning:
● Clean with a cotton gauze moistened with tap water and neutral
soap until no more contaminants are visible on the unit.
● Rinse under running water for at least 30 seconds.
● Dry the CEREC Guide 2 using a lint-free cloth.
Disinfecting
To disinfect use the product Sporox II disinfectant:
● Place the CEREC Guide 2 in a bath containing the undiluted
disinfection solution.
● Leave the CEREC Guide 2 immersed in the solution for 30 minutes.
● Wash the remaining disinfectant for 30 seconds with water of at
least drinking water quality.
● Dry the CEREC Guide 2 using a sterile lint-free cloth.
4.2.2 Cleaning the CERECGuide DrillKeys
A machine-based method can be used to clean the drill keys. Use the
cleaning agent neodisher® forte (Dr. Weigert, Germany) with a
concentration of 0.5% or a comparable cleaning agent.
For example, use the device WD BHT Innova® M3 and program 03 for
thermal disinfection:
1. Stage 1: Clean for 1 minute at 30 °C with 0.5% neodisher® forte.
2. Stage 2: Clean for 6 minutes at 55 °C with 0.5% neodisher® forte.
3. Stage 3: Rinse with completely demineralized water for 1 minute.

Dentsply Sirona
Operating Instructions CEREC Guide 2
4 Application
4.2 Cleaning, disinfection and sterilization
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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. The
sterilization time is 3minutes at 135°C / 275°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!

4 Application
4.3 Surgical intervention
Dentsply Sirona
Operating Instructions CEREC Guide 2
20
4.3 Surgical intervention
● CEREC Guide 2 must only be used in cases that have been planned
by a qualified dentist using the implant planning software
"GALILEOS Implant".
● The drill keys listed under the “Materials [→11]” section are
mandatory for every drilling process. Under no circumstances must
the drill be controlled with just the drill bit, without the use of a drill
key.
● The drill must only be operated once a suitable drill key is tightly
fitted in the drill bit and the tip of the drill is fully inserted through the
drill key in the apical direction.
● The drill must only be removed from the drill key or drill bit once it
has come to a complete standstill.
Important: Always observe the size specifications on the drill keys
and drill.
Example: The MØ2.2mm drill key is only permissible for 2.2mm
drills.
● The area around the implant must be amply sprayed and cooled
during the drilling process. The temperature in the drill channel must
be maintained to a minimum to prevent the hard tissue from
denaturing. No remnants of tissue must remain in the area around
the implant.
CAUTION
Remove burrs and round sharp corners on the template element.
Always check that the template fits correctly in the mouth beforehand
where necessary using a model. The template element must be
completely slid open and must not wobble.
Clean and disinfect the CEREC Guide 2 as described in the previous
chapter.
Select the drill key required which corresponds to the drills specified
by the manufacturer of the guided system. Also adhere to the drill key
assignment table.
Ensure that the drill key can fully enter the drill hole and stops there
without wobbling.
If you wish to use several surgical guides in an operation, ensure that
the drills and drill keys are correctly assigned to the respective
templates.
1. Perform the implantation according to the implant manufacturer’s
instructions.
2. Fix the template in the mouth, holding it in position with your finger if
necessary.
Tip: If you have created access to the drill from the side due to a lack of
space, first place the CEREC Guide 2 into the patient’s mouth. Then
guide the drill key through the drill and push it upwards. Now guide the
drill through the side into the sleeve position and lower the drill key to
the stop point. Then start drilling.