Gamma+ CADIAX compact Series User manual
CADIAX compact
GAMMA
Medizinisch-wissenschaftliche
Fortbildungs-GmbH
C
0483
A Practical Method for
TMJ Registration
Operating Instructions
CADIAX compact
© 2020 GAMMA Medizinisch-wissenschaftliche Fortbildungs-GmbH
Josef Brenner Strasse 10
3400 Klosterneuburg
Austria
Phone: +43 2243 34140
Fax: +43 2243 34140 90
E-Mail: office@gammadental.com
Internet: www.gammadental.com
C
0483
Operating Instructions
for
CADIAX compact 2, model A
Firmware version 1.14,
CADIAX compact 2, model B
Firmware version 2.13,
CADIAX 4, model A
Firmware version 2.13,
and
CADIAX compact 2 Recorder
version 2.15.0
Revision:
2020-01-31
4
CADIAX compact
CADIAX compact
5
Information in this publication is subject to change without prior notice. GAMMA Medizinisch-wis-
senschaftliche Fortbildungs-GmbH makes no warranty of any kind. GAMMA reserves the express right
to change this documentation without notification to any other party.
GAMMA cannot rule out that through system-, service-, or user-error, incorrect evaluations may be cal-
culated. Therefore, a plausibility check of the displayed data and calculations must always be carried out
by the patient's doctor. The final decisions on treatment and the responsibility for the patient always
rests with the attending physician. GAMMA Medizinisch-wissenschaftliche Fortbildungs-GmbH accepts
no liability.
Guarantee and Liability
© 2020 GAMMA Medizinisch-wissenschaftliche Fortbildungs-GmbH
This document contains information protected by copyright. All rights reserved. This document may not be duplicated, repro-
duced or translated into other languages, fully or partially, w ithout the express w ritten permission of GAMMA Medizinisch-
w issenschaftliche Fortbildungs-GmbH.
®, ™ Trademarks and Brands:
Axiograph and SAM are registered trademarks of the company SAM Präzisionstechnik GmbH, Germany. Microsoft and Win-
dows are trademarks of the company Microsoft Corporation, USA. Artex is trademark of the company Amann Girrbach
GmbH, Germany. Denar, Hanau and Whip Mix are trademarks of the company Whip Mix Corporation, USA. KaVo is trademark
of the company KaVo Kaltenbach & Voith GmbH & Co, Germany. Panadent is trademark of the company Panadent, USA.
GAMMA, GAMMA Dental Softw are, CADIAX and CADIAS are trademarks of the company GAMMA Medizinisch-w issenschaft-
liche Fortbildungs-GmbH, Austria. Stratos is trademark of the company Ivoclar Vivadent AG, Liechtenstein.
All of the products and product names mentioned in this handbook are brand names of the respective companies. The ab-
sence of the symbols ® or ™ does not imply that the name is an unprotected brand name.
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Content
7
Content
............................................................................................................. 101 Introduction
............................................................................................................. 101.1 Explanation of used symbols on packaging and device
............................................................................................................. 121.2 Important safety considerations
............................................................................................................. 121.2.1 General safety instructions
............................................................................................................. 141.2.2 Special information about medical electrical devices
............................................................................................................. 181.2.3 Contraindications - Limitations to application
............................................................................................................. 191.2.4 Magnet sensor system
............................................................................................................. 191.3 Intended purpose
............................................................................................................. 191.4 About this manual
............................................................................................................. 191.5 Symbols and notations
............................................................................................................. 201.6 User interface terminology
............................................................................................................. 211.7 Scope of delivery
............................................................................................................. 221.8 System requirements
............................................................................................................. 232 Preparing to operate the CADIAXdevice
............................................................................................................. 232.1 Installing the software
............................................................................................................. 252.2 Starting and activating the software
............................................................................................................. 272.3 Setting the face bow
............................................................................................................. 282.4 Setting the articulator
............................................................................................................. 303 Recording TMJ movement
............................................................................................................. 303.1 Posture of the patient
............................................................................................................. 303.2 Instructing the patient
............................................................................................................. 313.3 Preperations
............................................................................................................. 313.3.1 Entering patient information
............................................................................................................. 313.3.2 Fixing the clutch onto the lower jaw teeth
............................................................................................................. 363.4 Mounting the anatomic facebow
............................................................................................................. 363.4.1 Preparing the upper face bow
............................................................................................................. 373.4.2 Mounting the upper face bow
............................................................................................................. 383.4.3 Preparing the writing bow
............................................................................................................. 383.4.4 Mounting the writing bow
............................................................................................................. 403.4.5 Attaching the sensors
............................................................................................................. 413.5 Mounting the kinematic facebow
............................................................................................................. 413.5.1 Condylograph
............................................................................................................. 443.5.2 Condylograph comfort
............................................................................................................. 473.5.3 Preparing the lower face bow
............................................................................................................. 483.5.4 Mounting the writing bow
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............................................................................................................. 503.5.5 Determining the joint axis
............................................................................................................. 513.5.6 Attaching the sensors
............................................................................................................. 523.6 Setting up the CADIAXsystem
............................................................................................................. 533.7 Face bow parameter input
............................................................................................................. 533.7.1 Anatomic face bow
............................................................................................................. 543.7.2 Condylograph
............................................................................................................. 543.7.3 Condylograph comfort
............................................................................................................. 553.8 Setting the reference position
............................................................................................................. 553.9 Recording joint movements
............................................................................................................. 553.9.1 Joint track curves
............................................................................................................. 573.9.2 Condyle position measurement (CPM)
............................................................................................................. 583.10 Finishing the registration
............................................................................................................. 594 Data evaluation
............................................................................................................. 594.1 Retrieval and analysis of recordings
............................................................................................................. 604.2 Calculating articulator settings
............................................................................................................. 604.2.1 Condylar settings
............................................................................................................. 624.2.2 Sequence incisal table settings
............................................................................................................. 644.3 Data printout
............................................................................................................. 655 Mounting the articulator
............................................................................................................. 686 Troubleshooting
............................................................................................................. 717 Background information
............................................................................................................. 717.1 The reference coordinate system
............................................................................................................. 727.2 Exact and anatomic hinge axis
............................................................................................................. 737.3 Immediate side shift (ISS)
............................................................................................................. 748 Specifications
............................................................................................................. 748.1 Technical data
............................................................................................................. 748.2 Cleaning
............................................................................................................. 748.2.1 CADIAXdevice
............................................................................................................. 748.2.2 Measuring flags
............................................................................................................. 758.2.3 Measuring styli
............................................................................................................. 758.2.4 Face bow
............................................................................................................. 758.2.5 Functional occlusal clutch
............................................................................................................. 758.2.6 Occlusal tray clutch
............................................................................................................. 758.2.7 Bite fork
............................................................................................................. 758.2.8 3D joint support
............................................................................................................. 758.3 Recurrent tests
............................................................................................................. 768.4 Operating conditions
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1 Introduction
Thank you for showing your confidence in us by purchasing the CADIAX system. You have purchased a
top-quality medical device, designed based on more than 25 years of experience in the electronic con-
dylography registration.
In the following pages, we would like to help you get acquainted with the CADIAX device and its soft-
ware.
1.1 Explanation of used symbols on packaging and device
The following symbols are used on the product and/or within the operating instructions:
Attention: See accompanying instructions
Attention: Magnetic field
Follow operating instructions
Phone number
Fax number
E-Mail address
Internet address
Introduction
11
Manufacturer
Manufacturing date
Serial number
Upper and lower limit for temperature
Upper and lower limit for relative humidity
Upper and lower limit for atmospheric pressure
Do not sit on the device
Do not step on the device
Type B applied part
Dispose separately from other waste material
Direct Current (DC)
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Universal Serial Bus (USB)
Foot switch
or
Measuring sensors of the right patient side
or
Measuring sensors of the left patient side
1.2 Important safety considerations
For your own safety, as well as for operational safety, please read these instructions thor-
oughly, before beginning to operate the device. Always comply with any and all warnings
included in these instructions, and/or on the device itself.
1.2.1 General safety instructions
The device must be operated in a roomy area, in order to allow for proper dissipation of
heat.
Never operate the device in areas where there is a danger of water or other liquids seep-
ing into the device.
The device is powered by the computer it is connected to, through the Universal Serial
Bus (USB). Only connect the device directly to a computer's USB terminal. Never operate
the device through a USB hub and never use alternative power sources of any kind.
Never set up the system in the proximity of potential fields of electromagnetic interference
(loudspeakers, mobile phones, sterilizers, etc.).
Introduction
13
Never attempt to repair the device yourself. All repair work must be done by authorized,
trained technicians.
In the following cases disconnect the device from the computer and contact a qualified
service technician:
·
If water or other liquid seeps into the device.
·
If the device does not operate properly, although the operating instructions have been
followed correctly.
·
If the device has fallen down or if the housing is damaged.
·
If the device shows noticeable deviation from its normal operation.
Please make sure that the device is set up on a smooth, even surface, which is longer
and wider than the device itself.
The surface on which the device stands must be sufficiently stable, as the device could
be badly damaged by shaking or falling.
In choosing the working area and/or storage area, make sure that the device is not sub-
ject to extreme deviations in temperature or humidity, as well as to direct sunlight and ex-
cessive heat.
Make sure that the device is not subjected to vibrations and jolts.
Also make sure that the cable does not pose a hindrance (tripping hazard).
Do not sit on the device since this may cause it to be severely damaged.
Do not step on the device since this may cause it to be severely damaged.
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1.2.2 Special information about medical electrical devices
1.2.2.1 Setting up the CADIAX device
If the computer connected with the
CADIAX device is in the proximity of the
patient, it must have been tested in com-
pliance with standard EN 60601-1.
The patient proximity (definition according
to standard EN 60601-1) is the area
within which the patient could, intention-
ally or unintentionally, come into contact
with:
·
either any parts of the medical elec-
trical device/system, or
·
with someone using or touching a part
of the device/system.
Definition of patient proximity, according to standard EN
60601-1
If the computer connected with the CADIAX device is not built according to standard EN 60601-1, it
must be set up outside the proximity of the patient.
If such a computer is set up inside the patient's proximity, it and all devices connected to it (e.g. mon-
itor) have to be isolated according to EN 60601-1. Power sources have to be connected through a med-
ical isolation transformer and tethered network connections through a medical network isolator.
Introduction
15
Avoid using the CADIAX device directly next to other devices or stacked on top of other
devices, as this could lead to faulty operation. If, however, it is necessary to use the
device in the manner stated, the CADIAX device as well as the other devices must be
monitored to ensure they are working properly.
1.2.2.2 Operating the CADIAX device
Only switch the device into recording mode after the measuring sensors (flags and styli)
are completely mounted.
Make sure that the sensors are not touched during the registration, not by yourself nor by
the patient.
Always switch off the recording mode before detaching the flags and styli from the face
bow.
1.2.2.3 Features of the CADIAX compact 2 device enclosure
The enclosure of the CADIAX compact 2 main unit has the following features:
Front side
1
Connector socket for the measuring sensors of the right patient side
2
LED for indication of the current device status (refer to chapter "Status in-
dication of the CADIAX device ")
3
Connector socket for the measuring sensors of the left patient side
17
CADIAX compact
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Back side
4
Connector socket for the foot switch
5
Type label with information regarding the manufacturer and the device
6
USB 2.0 (type B) connector socket for the cable connection to the PC
1.2.2.4 Features of the CADIAX 4 device enclosure (compact sensor set)
When using the "compact" sensor set, the enclosure of the CADIAX 4 main unit has the following fea-
tures:
Front side
1
Unused connector socket
2
Connector socket for the measuring sensors of the right patient side
3
LED for indication of the current device status (refer to chapter "Status in-
dication of the CADIAX device ")
4
Connector socket for the measuring sensors of the left patient side
5
Unused connector socket
17
Introduction
17
Back side
6
Connector socket for the foot switch
7
Type label with information regarding the manufacturer and the device
8
USB 2.0 (type B) connector socket for the cable connection to the PC
1.2.2.5 Status indication of the CADIAX device
The CADIAX device indicates its operating state via a green LED on the front side of the enclosure. This
LED can be in the following conditions:
LED is permanently on:
Device is connected to a PC and is ready for
operation.
LED flashes with 5 Hz:
A measurement is in progress.
LED flashes with 0.5 Hz:
An internal hardware error occurred in the
device. No measurement is possible.
LED permanently off:
The device is not connected to a PC and is
turned off.
1.2.2.6 Electromagnetic compatibility
Medical electrical devices require special safety precautions with regard to electromag-
netic tolerance. Therefore, the CADIAX device may only be installed and put into opera-
tion according to the instructions contained in this manual. Failure to comply with the in-
structions herein can potentially impair the measurement accuracy stated in chapter
"Technical data ".
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CADIAX compact
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Only use accessories which are explicitly approved for CADIAX devices. Using other ac-
cessories, especially cables which are longer than the cable lengths prescribed below,
can lead to increased emission of interferences, or to reduced interference immunity of
the CADIAX device, which may lead to faulty operation.
The following accessories to the CADIAX system affect the system's electromagnetic compatibility and
may be replaced by the user. Components not listed here may only be replaced by the manufacturer.
Accessory
Maximum cable length
Foot switch
3.0 m
USB cable (USB 2.0, type A plug to type B plug, shielded)
3.0 m
CADIAX "compact" sensors
1.5 m
CADIAX "diagnostic" stylus (only applicable to CADIAX 4 devices)
1.5 m
CADIAX "diagnostic" flag (only applicable to CADIAX 4 devices)
1.5 m
Portable and mobile HF-communication appliances, e.g., mobile telephones, cordless
telephones, computers, and laptops with activated WiFi, etc., can have detrimental ef-
fects on medical electrical devices. Do not operate the CADIAX device in the proximity of
these potential sources of interference, and make sure to adhere to a safe distance of at
least 30 cm. Non-compliance can lead to reduced performance of the device.
1.2.2.7 Connecting other devices
Devices connected to analog or digital interfaces must be certified to satisfy the applic-
able standard EN specifications (e.g., EN 60950 for data-processing devices, or EN
60601 for medical electrical devices). In addition, all configurations must satisfy system
standard EN 60601-1. Whoever connects supplementary devices to the signal input or
outlet units is the system configurator and therefore responsible for ensuring that system
standard EN 60601-1 is adhered to.
1.2.3 Contraindications - Limitations to application
When operating the CADIAX system, the following conditions can hinder or limit its ap-
plication:
·
Cognitive abilities: Patients who are not able to follow or carry out the attending dent-
ist's instructions correctly (e.g., where to move the lower jaw, etc.), for physical or psy-
chological reasons.
·
General clinical symptoms: Patients with illnesses that do not allow for the attach-
ment of a face bow for registration purposes. Illnesses may be physical or psycholo-
gical in nature (e.g., spastic, epilepsy, claustrophobia, injury or disease of the skull or
soft-tissue structures of the skull, ears, etc.).
·
Dental clinical symptoms: Patients with odontopathy or periodontal disease, which
excludes the mounting of a clutch (parodontosis, loose teeth, damage to the tooth sub-
stance, changes in the mucous membranes in the mouth or pharynx, etc.).
Introduction
19
·
Certain diseases in the ear region: Patients with diseases in the ear region which
exclude the fixation of the face bow in the auditory canal (e.g., painful inflammations,
tinnitus, ear pain, etc.).
·
Muscle pain in the head and neck region: Patients with extreme muscle pain in the
head and neck region that are not able to wear the face bow for the duration of the ex-
amination.
·
Patients between 0 and 9 years of age: Experience has shown that children are first
able to follow the dentist's instructions well enough to lead to a successful examination
from about 10 years of age onwards. In addition, existent deciduous teeth can make it
difficult to fix the clutch.
·
Wearers of implants: Patients with active implants (e.g., cardiac pacemakers) should
be handled cautiously when using the CADIAX magnet-sensor system, as the stylus
tip, to which a magnet is attached, could come into proximity of such implants.
1.2.4 Magnet sensor system
The CADIAX Magnet-Sensor system ("M"-Sensor) contains a magnet in the tip of the
stylus. For this reason, special care is necessary when using it with patients with cardiac
pacemakers or implanted defibrillators. Make absolutely sure to adhere to the necessary
safe distances! If necessary, consult the responsible cardiologist. If in doubt, refrain from
using the CADIAX "M" Sensor system.
1.3 Intended purpose
The CADIAX system is designed for registration and display of hinge axis movements of the human
mandible, conversion of these movements to the intercondylar distance of an articulator, and calculating
the settings for this articulator, appropriate to the patient.
The system is used by dentists and dental technicians.
1.4 About this manual
The authors of this user manual assume that the reader has a basic knowledge of condylography, work-
ing with a face bow, and the transfer of its head-related data into an articulator.
In addition, a sound basis in the Microsoft Windows operational system is required. The user should be
able to work with the user-interfaces and other operational elements of the Windows programs.
This handbook is not a substitute for a basic education in using the Windows operating system. If you
have only little or no education in Windows, we recommend that you first become acquainted with the
system. This will make it much easier to work with the CADIAX software.
1.5 Symbols and notations
Special attention will be brought to important aspects using the following symbols:
Warning
Possible sources of error, or the danger of a possible operational error.
CADIAX compact
20
Attention
Especially important information regarding the topic being described.
Information
Useful tips and tricks.
The following symbols and notations will be used in this user manual to describe certain commands and
instructions for operating the software:
·
Designations of keys will be written in italic font style. For combinations of keys, the individual key
specifiers will be concatenated with plus signs (+). For example, Ctrl+D means: Hold down the Ctrl
key on your keyboard and simultaneously press the Dkey.
·
Names of menu items in the software will be written in italic font style. If several menu items need to
be selected in succession, they will be concatenated with arrows. For example, File Close means:
First, click on the File menu item in the menu bar, then click on the menu item Close in the opened
menu.
The first occurrence of Special Terms that may be used in subsequent descriptions are highlighted in
bold and italic font style.
1.6 User interface terminology
All GAMMA software applications use a user interface layout consisting of the following parts:
·
The Working Area is the area of the application that
displays the actual patient data and will therefore re-
ceive the highest amount of attention and interaction.
·
The hierarchical menu structure of the Menu Bar at
the upper border of the window provides access to
many of the application's functionalities. Most general
application settings that are independent of the actual
patient data can be configured here.
This manual suits for next models
4
Table of contents
