nobel biocare IPS CaseDesigner 2.0 Instructions For Use

IPS CaseDesigner® 2.0
Instructions for Use
Important: Please read.
Disclaimer of liability:
This product is part of an overall concept and may only be used in conjunction with
the associated original products according to the instructions and recommendation of
Nobel Biocare. Non-recommended use of products made by third parties in conjunction
with Nobel Biocare products will void any warranty or other obligation, express or
implied, of Nobel Biocare. The user of Nobel Biocare or KLS Martin products has the
duty to determine whether or not any product is suitable for the particular patient and
circumstances. Nobel Biocare disclaims any liability, express or implied, and shall have
no responsibility for any direct, indirect, punitive or other damages, arising out of or in
connection with any errors in professional judgment or practice in the use of Nobel Biocare
products. The user is also obliged to study the latest developments in regard to this
Nobel Biocare product and its applications regularly. In cases of doubt, the user has to
contact Nobel Biocare. Since the utilization of this product is under the control of the
user, it is his/her responsibility. Nobel Biocare does not assume any liability whatsoever for
damage arising thereof. Please note that some products detailed in this Instruction for Use
may not be regulatory cleared, released or licensed for sale in all markets.
Description:
IPS CaseDesigner® is a software solution supporting the diagnostic process of the
craniomaxillofacial complex and treatment planning of craniomaxillofacial procedures.
IPS CaseDesigner® has specific functionalities to visualise the diagnostic information,
e.g. from CT-imaging, to perform specific measurements in the image data and to plan
surgical actions in order to support the diagnostic and treatment planning process.
Based on the diagnostic and planning data, the IPS design service can offer individualised
surgical aids.
Intended use / Indications for use:
IPS CaseDesigner® is software indicated for supporting the diagnostic and treatment
planning process of craniomaxillofacial procedures. IPS CaseDesigner® is software that is
also used as an image segmentation system and for the transfer of imaging information
from a scanner such as a CT scanner. IPS CaseDesigner® also facilitates the service
offering of individualized surgical aids.
Contraindications:
None identified for IPS CaseDesigner®.
Warnings:
A number of technical warnings (e.g. inconsistent CT data, corrupt STL data) are
visualized in IPS CaseDesigner®.
Measurement accuracy depends on the image data, the used scanner hardware, its
calibration and acquisition settings. The measurement cannot be more precise than the
resolution of the image. IPS CaseDesigner® software reports the value, rounded to one
digit after the decimal point, based on user-picked points.
Incorrect alignment of upper jaw detected.
Use the Manual initialization action to obtain a correct alignment of the upper jaw to
reduce the risk of incorrect surgical planning.
Incorrect alignment of lower jaw detected.
Use the Manual initialization action to obtain a correct alignment of the lower jaw to
reduce the risk of incorrect surgical planning.
Incorrect alignment of both jaws detected.
Use the Manual initialization action to obtain a correct alignment of the jaws to reduce
the risk of incorrect surgical planning.
To separate both jaws, hard separation was used.
To reduce the risk of using incomplete (planning) information in the surgery plan,
adjust the Expert settings for fossa-condyle separation if you do not wish to use hard
separation.
To separate both jaws, normal separation was used.
To reduce the risk of using incomplete (planning) information in the surgery plan,
adjust the Expert settings for fossa-condyle separation if you wish to use a different
type of separation.
Incorrect jaw separation detected.
Adjust the Expert settings for fossa-condyle separation to obtain a correct jaw separa-
tion and to reduce the risk of incorrect surgical planning.
Upper jaw is manually initialized
The alignment calculation of the upper jaw is initialized by the corresponding points
placed in the Manual initialization action. Ensure correct jaw alignment before final-
izing the surgical plan to reduce the risk of incorrect surgical planning.
Lower jaw is manually initialized.
The alignment calculation of the lower jaw is initialized by the corresponding points
placed in the Manual initialization action. Ensure correct jaw alignment before final-
izing the surgical plan to reduce the risk of incorrect surgical planning.
Both jaws were manually initialized.
The alignment calculation of both jaws is initialized by the corresponding points placed
in the Manual initialization action. Ensure correct jaw alignment before finalizing the
surgical plan to reduce the risk of incorrect surgical planning.
The DICOM set slice thickness is too large
Please turn to the help files for information on how to create valid DICOM files accord-
ing to the recommended scan protocol.
The DICOM set has inconsistent slice increments
Please turn to the help files for information on how to create valid DICOM files accord-
ing to the recommended scan protocol.
The DICOM set slice increment is too large
Please turn to the help files for information on how to create valid DICOM files accord-
ing to the recommended scan protocol.
Corrupt file
File of ["upper scan","lower scan", "occlusion scan" ] could not be opened, please
select another file. If the problem persists, contact customer support.
Corrupt files
Both files could not be opened, please select other files. If the problem persists,
contact customer support.
1/2
This patient name differs from the patient DICOM set
To reduce the risk of using incorrect data to create the patient model, verify the
patient name and check whether patient name and the name in the used DICOM set
correspond.
Finalize splint for current surgical plan
The generated splint files are only valid for the planned surgery. If you want to change
the surgical plan, use the unlock action to remove the splint and make changes.
Be aware that locally-produced surgical splints must be fabricated using validated
processes and appropriate materials according to the manufacturer's instructions for
use. Optimal fit should be verified prior to surgery.
Intersecting models detected. Increase the autorotation value
Increase the autorotation value to reduce the risk of a surgical misfit.
Intersecting models
Adjust the autorotation to avoid intersecting models. Press Continue if you want to
proceed creating the splint.
Fragments might be intersecting
When in the Virtual Occlusion wizard upper and lower jaw intersect, grinding will be
required to be able to achieve the final occlusal position.
Cautions:
When using a new device/treatment method for the first time, working with a colleague
who is experienced with the new device/treatment method may help avoid possible
complications.
Handling instructions:
General operating instructions:
The use of IPS CaseDesigner® requires the user to have the necessary training and
domain knowledge in the practice of craniomaxillofacial surgery.
Users are advised to obtain training before undertaking a new treatment method or using
a new device.
Cybersecurity:
It is recommended that you have active and up-to-date antivirus and anti-malware
software – together with a correctly configured firewall – on the computer on which
you are using IPS CaseDesigner®. Furthermore, always lock the computer when it is left
unattended.
Professional use:
IPS CaseDesigner® is for professional use only: clinicians, nurses, dental technicians and
designers of individualized surgical aids. The product is to be used in a clinic, private
practice, dental laboratory or as a software tool in a design service for surgical aids.
Additional information:
IPS CaseDesigner® has dependencies on the operating systems it is used with. It
is therefore important to make sure IPS CaseDesigner® is used only with approved
operating systems. More information about which operating systems are approved can
be found in the 'Computer Guidelines for IPS CaseDesigner®'.
Installing IPS CaseDesigner®:
Install the software according to the IPS CaseDesigner® Installation Guide.
How to start the software:
To open the application, double-click on the IPS CaseDesigner® shortcut icon on the
desktop. The software opens, allowing you to start working with patient files.