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Operating Instructions
Sirona Dental Systems GmbH
Operating Instructions CEREC Guide
Table of contents
1
General information..................................................................................................
3
1.1
Structure of the document.............................................................................
3
1.1.1 Identification of the danger levels.......................................................
3
1.1.2 Formats and symbols used ................................................................
3
1.2
Symbols used................................................................................................
4
1.3
Intended use .................................................................................................
4
1.4
Indications .....................................................................................................
4
2
Safety instructions ....................................................................................................
5
3
Product description...................................................................................................
6
3.1
Description of the CEREC Guide surgical guide ...........................................
6
3.2
Materials........................................................................................................
6
Application................................................................................................................
9
4.1
Application information ..................................................................................
9
4.2
Preparation of the scan template ..................................................................
9
4.3
Planning the implant and exporting the data .................................................
12
4.4
Milling the drill bit...........................................................................................
13
4.5
Creating the surgical guide ...........................................................................
13
Disinfection/sterilization of the surgical guide...........................................................
16
4
5
2
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1 General information
Operating Instructions CEREC Guide
1.1 Structure of the document
1
General information
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.
1.1 Structure of the document
Structure of the document
1.1.1
Identification of the danger levels
Identification of the danger levels
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.
1.1.2
Formats and symbols used
Formats and symbols used
The formats and symbols used in this document have the following
meaning:
✔ Prerequisite
Prompts you to do something.
1. First action step
2. Second action step
or
➢
Alternative action
 Result
See "Formats and symbols
used [ → 3]“
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Identifies a reference to another
text passage and specifies its page
number.
3
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To prevent personal injury and material damage, please observe the
warning and safety information provided in this document. Such
information is highlighted as follows:
1 General information
Sirona Dental Systems GmbH
1.2 Symbols used
Operating Instructions CEREC Guide
● List
Designates a list.
"Command/menu item"
Identifies commands, menu items
or quotations.
1.2 Symbols used
NOTICE! Observe Operating Instructions!
Symbols used
This product is a medical device in accordance with Council Directive 93/
42/EEC.
Rx only: Federal law (USA)
0123
Rx only
REF
LOT
CAUTION: According to US Federal Law, this product may be sold only
to or by instruction of physicians, dentists, or licensed professionals.
ABC123
ABC123
Article number
Batch number
This product is intended for single use only
non-sterile
NON
STERILE
1.3 Intended use
Intended use
The CEREC Guide concept is designed for the manufacture of individual
implant surgical guides by specialist dental staff/technicians. The surgical
guide is designed as an auxiliary device for dental surgery.
The CEREC Guide requires the CEREC system and a 3D X-ray system
from Sirona, such as GALILEOS or ORTHOPHOS XG 3D
1.4 Indications
Indications
The CEREC Guide is used for dental implants that are completed with
supported and managed surgical systems (refer to Materials [ → 6]).
4
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2 Safety instructions
Operating Instructions CEREC Guide
2
Safety instructions
Safety instructions
Exclusion of liability
The surgical guide created with the CEREC 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.
The CEREC Guide enables you as a clinician or technician to create your
own surgical guide using a MC XL milling machine. The CEREC Guide is
not a fully automatic solution. It cannot be compared to a surgical guide
that has been manufactured centrally based on your design.
The CEREC Guide must not be used to manufacture templates that are
bigger than a quadrant.
No more than two implants should be set per template.
The thermoplast process is only approved for the extraoral creation of the
scan template (on a model).
Prerequisites
● CEREC or inLab MC XL milling unit
● GALILEOS or ORTHOPHOS XG 3D
● CEREC SW 4.0.2 or higher
● CEREC SW license "Open GALILEOS Implant"
● Implant planning software "GALILEOS Implant", V1.9 with SP1 or
higher
CAUTION
Errors when setting the tooth numbering
When setting the tooth numbering to the American (ADA) pattern, an
error in GALILEOS Implant V1.9 can cause invalid export data. This can
cause the tooth number to be mixed up and hence injure the patient.
➢ Version 1.9 with SP1 is mandatory!
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.
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Limitations
3 Product description
Sirona Dental Systems GmbH
3.1 Description of the CEREC Guide surgical guide
3
Operating Instructions CEREC Guide
Product description
Product description
3.1 Description of the CEREC Guide surgical guide
Description of the CEREC Guide surgical guide
Using the CEREC Guide, you can create a precise surgical guide in your
practice/laboratory. The process is fast and incurs comparatively low
costs.
The individually manufactured surgical guide is part of the integrated
implant plan and surgical implementation using CAD/CAM and 3D X-ray
systems from Sirona.
3.2 Materials
Materials
Thermoplast
Thermoplast is a rigid plastic. When heated with hot water it becomes soft
and easily pliable.
Recommended materials:
● Hydroplastic from TAK Systems
● Luxaform from DMG Dental
Important: When handling these materials, please observe the relevant
application descriptions from the manufacturers.
CEREC Guide blocks
CEREC Guide blocks
Product name
Size
REF
Sirona CEREC Guide Blocs S
Small
63 75 054
Sirona CEREC Guide Blocs M
Medium
63 75 062
Sirona CEREC Guide Blocs L
Large
63 75 070
In each case, two unsterile CEREC Guide blocks and two unsterile
CEREC Guide reference units (refer to Materials [ → 7]) are supplied.
These parts are intended for single use only.
CEREC blocks are made of clear Plexiglas® GS 0F00.
6
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3 Product description
Operating Instructions CEREC Guide
3.2 Materials
CEREC Guide reference units
CEREC Guide reference units
Size
Color
Thinnest
part
Drill hole
Mesial/distal
shifting
Small (S)
Orange
6 mm
up to
3.5 mm
max. 1.5 mm
Medium (M)
White
7.3 mm
up to
4.3 mm
max. 2 mm
Large (L)
Gray
11 mm
up to
6 mm
max. 4 mm
CEREC Guide reference units are made of Hostaform® MT 12U01 plastic
and are supplied unsterile. Seven glass soda balls are located in the
reference units as radio-opaque markers.
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Drill key
Drill key sets
Designation
REF
Suitable for surgical kit
63 73 711
Sirona CEREC
Guide Drill Key Set
ST
Straumann®:
63 73 729
Sirona CEREC
Guide Drill Key Set
C
Camlog®:
63 73 943
Sirona CEREC
Guide Drill Key Set
NB
Guided Surgery Kit
Guided Drill Set
Nobel Biocare:
● Branemark® System Guided
Surgery Kit
● NobelReplace® Straight Guided
Surgery Kit
● NobelReplace® Tapered Guided
Surgery Kit
● NobelActive Guided Surgery Kit
6373950
Sirona CEREC
Guide Drill Key Set
AT
AstraTech: Facilitate
6373968
Sirona CEREC
Guide Drill Key Set
B
Biomet 3i: Navigator
CEREC Guide drill keys are made of grade 1.4301 stainless steel and are
supplied unsterile.
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3 Product description
Sirona Dental Systems GmbH
3.2 Materials
Operating Instructions CEREC Guide
Each drill key is labelled
● Some drill keys are labelled with supported manufacturers, for
example, "ST" for Straumann®. The Straumann key set only
comprises drill keys that can be used with Straumann drills.
Universal drill keys are not labelled with a manufacturer. These keys
can be included in several key sets. You can use them in conjunction
with the labelled keys in the key set.
● S, M, or L depending on the reference unit being used as it
determines the size of the drill channel in the block. Each drill key
transfers a S, M, or L drill channel to the exact width of the drill being
used.
● The diameter in mm of the drill that must be used.
Examples:
"ST-M Ø4.2" (only with the Straumann key set)
Is used to support the 4.2mm drill in medium-sized blocks (if the mediumsized reference unit was used)
""L Ø2.0" (for Nobel Biocare, Astra Tech, and Biomet 3i)
Is used to support the 2.0mm pilot bit in large blocks (if the large
reference unit was used).
8
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4 Application
Operating Instructions CEREC Guide
4.1 Application information
4
Application
Application
4.1 Application information
Application information
● The CEREC Guide must only be used in cases that have been
planned by a qualified dentist using the implant planning software
GALILEOS Implant or SICAT Implant.
● The drill keys listed in theMaterials [ → 6]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 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,
reference units, blocks, and drill.
Example: The MØ2.2 mm drill key is only permissible for 2.2 mm
drills following the application of a medium-sized reference unit.
● 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.
● All materials that are used intraorally must be disinfected before use
and safeguarded against aspiration when being used.
● The materials Thermoplast, CEREC Guide blocks and CEREC Guide
reference units (refer to "Materials [ → 6]") are intended for single use
only and are not supplied in sterile packaging, also refer to
"Disinfection/sterilization of the surgical guide [ → 16]".
● Please protect the surgical guide from direct sunlight and high
temperatures 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 Preparation of the scan template
Preparation of the scan template
The heated Thermoplast is used to create an imprint of the implant area.
The Thermoplast fixes the reference unit inserted on the required drilling
position. The 3D X-ray can then be taken.
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● 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.
4 Application
Sirona Dental Systems GmbH
4.2 Preparation of the scan template
Operating Instructions CEREC Guide
✔ The "implant" indication is then completed, refer to Indications [ → 4].
1. Optional: Where applicable, complete an initial CEREC scan to plan
the prosthetics.
IMPORTANT
Observing the undercuts
Check the location of the implant for any problematic undercuts.
➢ If necessary, manually even these out, for example, by using
silicone-based material. Do not use wax as it can melt when it
comes into contact with warm Thermoplast.
➢ The template must be able to be fitted and removed again with
justifiable force.
2. Create a plaster model and block off any critical areas such as
undercuts using a suitable material. This material must not be heat
sensitive.
3. Prepare a reference unit for use. Select a size that is in accordance
with the location of the implant.
Tip: Always use the largest possible reference unit that will fit in the
gap.
4. Place the Thermoplast material in a sufficiently large glass bowl.
5. Bring the water to the boil and pour the water directly over the
Thermoplast so that it is fully covered.
 Thermoplast melts at 90°C (195°F) and becomes a transparent,
easily pliable mass.
 The Thermoplast is completely transparent after two to three
minutes (depending on the manufacturer).
6. CAUTION! Risk of burning! Do not place your hands in the water
bath. Use a tool to remove the material from the water.
Remove the material from the water, for example, using metal
tweezers.
IMPORTANT
Processing time
Thermoplast hardens as it cools and also loses its transparency. After
removing it from the water bath you will have one to three minutes to
process the Thermoplast.
Hardened Thermoplast can be reheated in the water bath.
7. Depending on the type of plaster: Moisten the plaster model so that
the Thermoplast can be removed easily. CEREC Stone BC generally
does not need to be moistened as Thermoplast does not connect with
the material.
8. In accordance with the location of the implant, shape a 2-3 mm thick
plate using the Thermoplast.
9. Shape it over the location of the implant in such a way that at least
the distal and mesial adjacent teeth are covered with Thermoplast.
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4 Application
Operating Instructions CEREC Guide
4.2 Preparation of the scan template
10. Optional: Before placing the Thermoplast on the model, you can use
the reference unit to create a hole in the Thermoplast. This facilitates
the later removal of the residual material between the reference unit
and gingiva.
11. Position the Thermoplast on the prepared area. Create an imprint by
applying light pressure.
 The Thermoplast must be pressed closely on the location of the
implant and enclose it fully. Following the casting process, the
template must have a stable fit.
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12. Press the reference unit into the required drilling position in the
Thermoplast that is still soft.
IMPORTANT
Positioning the reference unit
The reference unit must be pushed as far in to the apical direction as
possible so that it rests on the gingiva. The template and the reference
unit must not be able to be moved. The risk of any displacement caused
by the tongue/cheek must be avoided.
The Thermoplast must not cover the reference unit. However, it must
surround the reference unit up to the small undercut on the shoulder.
If the Thermoplast moves too far in a buccal or lingual direction when the
reference unit is pushed in, it must be pushed back on to the reference
unit.
If two implants are to be located next to each other, align a scanbody
orally and according to the vestibular.
13. To accelerate the hardening process of the Thermoplast, you can
cool it with water or a spray.
14. Remove the scan template from the model once it is completely
hardened.
Tip: You can prevent the opposite jaw from moving during the X-ray.
Insert additional Thermoplast to the side of the position of the implant to
create a surface for the antagonist. Apply slight pressure to the soft mass.
Once the material has hardened, the patient can bite down on it during
the X-ray. Remove this Thermoplast again after the X-ray.
WARNING
Before using the scan template in the mouth, it must first be disinfected
with a suitable disinfectant. Please also observe the cleaning
specifications provided by the Thermoplast manufacturer.
Thermoplasts can generally not be autoclaved.
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4 Application
Sirona Dental Systems GmbH
4.3 Planning the implant and exporting the data
Operating Instructions CEREC Guide
4.3 Planning the implant and exporting the data
Planning the implant and exporting the data
1. Insert the first scan template into the patient's mouth. Check that the
seating of the template is stable and accurate. Ensure that the
template and reference unit cannot move during the X-ray.
2. Take an X-ray of the patient with the scan template in place. Please
refer to the operating instructions for your Sirona 3D X-ray device.
3. Remove the scan template from the patient's mouth immediately after
the X-ray.
4. Open the software GALILEOS Implant or SICAT Implant and load the
patient's data record.
5. To plan the implant and localize the reference unit follow the
instructions provided in the "GALILEOS Implant" operator's manual.
Follow the instructions provided in the chapter "Exporting plan for
third-party processing".
Take the length of the drill into consideration. The drill key has an
additional height of 1mm that must be subtracted from the length of
the drill to determine the distance "D2".
A
Drill
D
Drill length
B
Drilling length stop
E
Height of the drill bit (D2) to be
created
C
Implant apex (lowest drill
position)
F
Drill key height (1mm)
6. Determine the length of the depth stop "D2" and add it to the plan in
GALILEOS Implant before the export. The distance "D2" corresponds
to E in the screenshot above and is determined as follows: Drill
length -1mm
The length of the drill corresponds to the manufacturer's
specifications. If you do not have these to hand, you can also
determine the length of the drill yourself with a slide controller.
The 1mm allowance corresponds to the strength of the drill key.
7. Export the data for CEREC. Follow the instructions provided in the
chapter "Exporting the plan" in the "GALILEOS Implant" operator's
manual.
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4 Application
Operating Instructions CEREC Guide
4.4 Milling the drill bit
4.4 Milling the drill bit
Milling the drill bit
✔ The CEREC SW software has been started.
1. Import the data in to CEREC SW. To do so, click on "Import Case..."
in the system menu. Ensure that the file type filter in the bottom right
corner of the "Open" dialog is set to CEREC Guide cases.
2. Select the file that you have just exported from GALILEOS Implant.
Tip: In standard mode, GALILEOS Implant exports CEREC Guide
cases to C:\ThirdPartyExport
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 The milling preview is opened.
3. Select the required milling unit, where applicable.
4. Insert the correct block into the milling chamber.
5. Start the milling process.
 The drill bit is created.
6. Remove the drill bit from the block. Ensure that the sprue position on
the drill bit is as flush as possible when disconnected. The best
results are achieved by using cross-toothed plastic milling tools at a
low speed.
4.5 Creating the surgical guide
Creating the surgical guide
The scan template is now used to create a surgical guide, by removing
the reference unit(s) and replacing it/them with the suitable drill bit(s).
Tip: In the event of several implants, the drill bits can be distinguished by
the tooth number that is engraved on the drill bit.
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4 Application
4.5 Creating the surgical guide
Sirona Dental Systems GmbH
Operating Instructions CEREC Guide
1. Carefully twist the reference unit to remove it from the scan template.
2. Ensure that there is no Thermoplast residue under the drill bit. The
drill channel must not be blocked. Use a sharp scalpel.
Tip: Thin areas of the hardened Thermoplast can be cut using a
scalpel. Stronger parts can be processed with a very slow turning
handpiece, such as a three-edged cutter for processing
thermoforming films.
When processing, use a water spray for cooling purposes. If the
instrument causes the Thermoplast to become too warm, the plastic
will become liquid again, deform, and block the instrument. Therefore
only use the handpiece in areas that are too thick for the scalpel.
3. Use the model to ensure that adequate drainage of the rinsing liquid
is guaranteed during the operation. Adapt the template, if necessary,
by adding holes for rinsing purposes.
4. Insert the drill bit into the template. Attach the drill bit with adhesive
that is approved for intraoral applications (e.g. LOCTITE® 4601).
5. Reinsert the template into the patient's mouth.
6. Place the relevant drill key on the drill bit. Be aware of the diameter
of the drill and the size of the block.
14
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4 Application
Operating Instructions CEREC Guide
4.5 Creating the surgical guide
CAUTION
This checklist must be fully verified before the drilling process:
➢ Drill bit is fixed in the template.
➢ Surgical guide clicks into the correct position
➢ Once in place, the surgical guide is secured tightly (no "play" or
"wobbling")
➢ The drill channel guide corresponds to the implant plan
 If one of these points does not apply, an optical impression
(CEREC) of the situation must be imported into the X-ray volume
and a SICAT OptiGuide must be ordered, refer to the "GALILEOS
Implant" manual.
båÖäáëÜ
7. Start the implantation in accordance with the instructions provided by
your drill supplier.
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5 Disinfection/sterilization of the surgical guide
Sirona Dental Systems GmbH
Operating Instructions CEREC Guide
5
Disinfection/sterilization of the surgical
guide
Disinfection/sterilization of the surgical guide
Disinfecting
The materials used for the drill key (including its drill sleeve) are supplied
unsterilized and must be disinfected along with standard practice
equipment.
Recommended disinfectant e.g.
"Dentavon® Liquid" from Schülke & Mayr
Please also observe the cleaning specifications provided by the
Thermoplast manufacturer.
Sterilizing
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.
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!
16
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5 Disinfection/sterilization of the surgical guide
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Operating Instructions CEREC Guide
63 91 473 D3587
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17
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