SICAT JMT+ Instruction manual

SICAT JMT
⁺
JAW MOTION ANALYSIS SYSTEM
Technical data and instructions for use – English

CONTENTS
Page 2 of 40 SICAT JMT⁺-Jaw motion analysis system
CONTENTS
1 User information .................................................................................................................................... 4
1.1 Manufacturer information......................................................................................................................................... 4
1.2 Configuration of the instructions for use.................................................................................................................. 4
1.3 Used symbols............................................................................................................................................................. 5
2 Area of use and safety ............................................................................................................................. 6
2.1 Intended use .............................................................................................................................................................. 6
2.1.1 Use.................................................................................................................................................................. 6
2.1.2 SICAT data export.......................................................................................................................................... 7
2.2 Safety.......................................................................................................................................................................... 7
2.2.1 Environmental conditions ............................................................................................................................ 7
2.2.2 Storage and transport................................................................................................................................... 7
2.2.3 Obligations of the user.................................................................................................................................. 8
2.2.4 General safety information........................................................................................................................... 8
2.2.5 Safety information on heart pacemakers / defibrillators ........................................................................... 9
2.2.6 Prohibited use ............................................................................................................................................. 10
3 Product description .............................................................................................................................. 11
3.1 System components................................................................................................................................................ 11
3.2 Technical data of the SICAT JMT⁺ measurement system ...................................................................................... 11
3.3 Measurement principle of the SICAT JMT⁺ jaw motion analysis system .............................................................. 12
3.4 Control elements and connections......................................................................................................................... 13
3.5 Meaning of the display lights .................................................................................................................................. 15
3.6 Assignment of the connecting sockets................................................................................................................... 16
3.7 Accessories and spare parts.................................................................................................................................... 18
4 Putting the measurement system into operation .................................................................................... 21
4.1 Power supply and charging the battery ................................................................................................................. 21
4.2 Computer requirements.......................................................................................................................................... 22
4.3 Installing the SICAT JMT⁺ software......................................................................................................................... 22
4.4 Connecting the accessory parts.............................................................................................................................. 23
4.5 Taking the measurement system out of operation ............................................................................................... 23
5 Functional checks, preparation, disposal ............................................................................................... 24
5.1 Specified regular checks and technical safety checks........................................................................................... 24
5.2 Checking the measurement function ..................................................................................................................... 25
5.3 Rectifying faults ....................................................................................................................................................... 25
5.4 Preparation methods .............................................................................................................................................. 26
5.4.1 Manual cleaning .......................................................................................................................................... 26
5.4.2 Manual disinfection..................................................................................................................................... 27
5.4.3 Sterilization ................................................................................................................................................. 27
5.5 Disposal.................................................................................................................................................................... 28
5.5.1 Packaging .................................................................................................................................................... 28
5.5.2 Disposal of electronic waste....................................................................................................................... 28
5.5.3 Accumulators and batteries ....................................................................................................................... 28
6 Safety standards and classification of the system ................................................................................... 29

CONTENTS
SICAT JMT⁺-Jaw motion analysis system Page 3 of 40
6.1 Classification pursuant to appendix IX of the Directive 93/42/EEC....................................................................... 29
6.2 Safety of electrical medical devices........................................................................................................................ 29
6.2.1 Connection of the SICAT JMT⁺ measurement system with other electrical devices ............................... 29
6.2.2 Environment of the patient / test person................................................................................................... 30
6.3 Electromagnetic compatibility for guidelines / manufacturer declaration ......................................................... 31
Glossary .............................................................................................................................................. 36
Index ................................................................................................................................................... 37
Contact................................................................................................................................................ 38

USER INFORMATION
Page 4 of 40 SICAT JMT⁺-Jaw motion analysis system
1 USER INFORMATION
1.1 MANUFACTURER INFORMATION
SICAT GmbH & Co. KG
Brunnenallee 6
53177 Bonn
Germany
Telephone +49 (0)228 / 854697-11
Email: [email protected]
Internet: www.sicat.com
1.2 CONFIGURATION OF THE INSTRUCTIONS FOR USE
The instructions for use for the SICAT JMT⁺ jaw motion analysis system consist of two parts:
1. SICAT JMT⁺ system technical data and instructions for use
2. SICAT JMT⁺ instructions for use of the user software
The part SICAT JMT⁺ system technical data and instructions for use primarily contains information
concerning the technical data and operation of the SICAT JMT⁺ system, as well as information on its safe
operation in combination with the patient accessories such as the SICAT Fusion Bite. Information
concerning accessory components is limited to key safety and maintenance measures and/or hygiene
measures.
CAUTION
The exact compliance with the information in both parts of the instructions for
use is required for proper use.

USER INFORMATION
SICAT JMT⁺-Jaw motion analysis system Page 5 of 40
1.3 USED SYMBOLS
Green highlighting around the side of the instructions for use designates new information concerning
product safety.
Warning instructions designate a potential danger to the health and safety of users and/or patients. The
instructions explain the type of danger and how it can be avoided.
NOTICE Notices designate a potential danger that can cause damage to the device. The
instructions explain the type of danger and how it can be avoided.
The CE mark with code number 0197 of the notified body TÜV Rheinland LGA Products GmbH confirms
the conformity of the measurement system with guideline 93/42/EEC (Medical Devices Directive).
Symbol for manufacturer and date of manufacture
Type BF device corresponding to DIN EN 60601-1
USB port
This symbol shows that pursuant to the Directive on Waste Electrical and Electronic Devices (2012/19/EU)
and national legislation, a product cannot be disposed of via the household waste, and must be disposed
of separately within Europe.
Icon for HF-transmitter (Bluetooth interface)
Article number of the measurement system / accessory
Serial number of the measurement system
An accessory that is intended for one-off use on a single patient during a single treatment.
Refer to instructions for use.

AREA OF USE AND SAFETY
Page 6 of 40 SICAT JMT⁺-Jaw motion analysis system
2 AREA OF USE AND SAFETY
2.1 INTENDED USE
Based on the lower jaw movements of the patient, the SICAT JMT⁺ system calculates all the necessary
parameters with the goal of a supporting diagnosis for the following indications:
■supporting diagnosis for treating a diseased mandibular joint
■supporting diagnosis for creating occlusal mouth-guards
■supporting diagnosis for creating dentures
■supporting diagnosis for aesthetically functional reconstruction with or without tooth implants
■supporting diagnosis for treating craniomandibular dysfunction (CMD)
The measurement system also enables the exporting of the gathered data for further processing with
CAD/CAM or PACS systems.
The measurement system may only be used by trained dentists. The area of use is limited to dental
systems. A measurement is carried out within 15 minutes and should not be applied in the case of open
wounds in the oral and head area; it can be applied to patients who are over 10 years old and who are
mentally capable of exactly following the instructions of the operator.
2.1.1 USE
The SICAT JMT⁺ system is an electronic recording system that is based on 3D ultrasound measurements.
SICAT JMT⁺ systems record the lower jaw movements of the patient in all degrees of freedom.
The 3D presentation of the positions and movement paths of occlusal or juxta-articular measurement
points provides important information on the movement behavior of the mandibular joint and the teeth
on the lower and/or upper jaw. The 3D presentation of distinctive positions in the face provides a
mapping of the face symmetry for the fitting of the denture. In a functional, preliminary examination, any
discoordinations and limitations of movement can be analyzed and documented.
The electronic position analysis of the condyles enables different occlusion positions to be compared and
can thereby indicate possible pain vectors in the joint.
An analysis of the chewing movements takes place with a special software module. The XML export
function enables the use of jaw movements determined with the SICAT JMT⁺ system in CAD/CAM systems
and PACS systems for the functional optimization of dentures and of mouth-guards.
The measurement system may only be used by trained personnel, meaning dentists in dental facilities.
The SICAT JMT⁺ system is used to support the functional diagnosis. The measurement sensor technology
consists of a receiving sensor and a transmitting sensor. This is attached to the patient's head. The lower
jaw sensor technology is fitted with a special locking mechanism for fixing it to the attachment. The face
bow is positioned at the front with the support on the nasion and at the back of the head above the ears.
A measurement can then be carried out according to the required settings and measurement parameters
in the software.
All the measurement and/or analysis results of the SICAT JMT⁺ system should always be interpreted by a
trained specialist and checked for their relevance in consideration of the clinical medical history of the
patient and in the context of the further diagnostic procedure. If invasive measures are taken, the
measurement system should only be used as an additional assessment method. Under no circumstances
can or should invasive surgery or measures that put the patient at risk be carried out based on the
measurement results alone.

AREA OF USE AND SAFETY
SICAT JMT⁺-Jaw motion analysis system Page 7 of 40
2.1.2 SICAT DATA EXPORT
The JMT export function enables the use of jaw movements determined with the SICAT JMT⁺ system in
CAD/CAM systems and PACS systems for the functional optimization of dentures and of mouth-guards.
The SICAT Fusion Bite serves as an interface for the referencing. It carries reference marks that can be
captured by imaging systems such as surface scanners or DVT.
2.2 SAFETY
2.2.1 ENVIRONMENTAL CONDITIONS
The SICAT JMT⁺ jaw motion analysis system is suitable for use in dry interior rooms, as can be found in
clinics, medical practices and laboratories.
Permissible operating temperature: 10°C to 40°C
Relative humidity: 30 % to 70 %
CAUTION
The device should not be operated in wet zones, damp areas (swimming baths,
saunas) or climatic chambers.
The measurement systems are not intended for use in areas where there is a risk
of explosion, rooms used for medical purposes or in a flammable atmosphere
(oxygen-enriched).
The devices should not be used near engines or transformers with a big
connected load, for example, or heavy current power lines, as electrical or
magnetic interference fields can distort the correct measurements and/or make
them impossible.
To avoid reciprocal faults from occurring, two SICAT JMT⁺ systems should never
be operated in the same room or near other ultrasound emitting devices (e.g.
ultrasonic cleaners, bird scare devices, alarm systems), as this can cause the
measured values to be falsified.
2.2.2 STORAGE AND TRANSPORT
The storage and transport of the measurement system should only be carried out in the original
packaging, as provided by SICAT.
Storage temperature: -20°C to +70°C
Relative humidity: 5% to 90%
Air pressure: 700hPa to 1060hPa

AREA OF USE AND SAFETY
Page 8 of 40 SICAT JMT⁺-Jaw motion analysis system
2.2.3 OBLIGATIONS OF THE USER
■The general guidelines and/or national legislation, national regulations and technical regulations
pertaining to medical products are to be applied and fulfilled both with the start-up and during the
operation of the SICAT product appropriate to the stated purpose. In Germany, operators, those
responsible for such devices, and users are obliged to operate their devices in compliance with the
MPG (Medical Devices Act) regulations.
■It is the obligation of the user:
– to comply with all the safety instructions stated in the instructions for use.
– to carry out all of the inspection and maintenance work regularly as specified in the instructions
for use.
– to only use fault free working equipment.
– to ensure that the device is functionally safe and in a proper state prior to every instance of use of
the device.
– to ensure all the provided instructions for use that form part of the measurement system, are
accessible to all users at all time, and to keep them near the measurement system.
– to protect oneself, the patients and third parties against dangers.
– to prevent a contamination occurring due to the product.
■During use, it is necessary to comply with the legal regulations, especially:
– the current work safety regulations.
– the current accident prevention measures.
■Responsibility is assumed to ensure the safety, reliability and effective performance of all
measurement systems and accessories delivered by SICAT, such that:
– assembly work, extensions, new settings, changes or repairs are carried out by SICAT or third
parties authorized by SICAT, trained technicians or by the personnel of authorized dealers. The
storage and transport should only be carried out in the original packaging, as provided by the
manufacturer.
– the product is operated in compliance with the instructions for use.
– the information technology components provided by the operator comply with the technical
requirements for hardware and software contained in these instructions for use, and that they
are installed and set up according to the applicable descriptions for these components.
– the place of installation corresponds with the specified environmental conditions for the
measurement system and the current installation regulations.
– only the software made available by SICAT, as well as the components and accessory parts listed
in these instructions for use are used with the system.
2.2.4 GENERAL SAFETY INFORMATION
■The use and operation of the system and the evaluation of measurement data and its interpretation
should only be carried out by trained specialist personnel. The manufacturer assumes no liability for
damage to persons or property, or the loss of data that may occur due to the improper use of the
software, the device, or its accessory parts.
■Patients and measurement data may only be copied, moved or deleted with the help of the database
function that is provided by the SICAT application program. In the case of the deliberate changing of
data without the database functions, the user alone bears the full risk.
■All measurement and/or analysis results should always be interpreted by a trained specialist and
checked for their relevance in consideration of the clinical medical history of the patient and in the
context of the further diagnostic procedure. If invasive measures are taken, the measurement system

AREA OF USE AND SAFETY
SICAT JMT⁺-Jaw motion analysis system Page 9 of 40
should only be used as an additional assessment method. Under no circumstances can or should
invasive surgery or measures that put the patient at risk be carried out based on the measurement
results alone.
■In the case of malfunctions and/or defects being suspected and/or ascertained, the device has to be
taken out of use immediately, labelled as 'Out of Use', and secured to prevent use. Please contact the
manufacturer or your sales partner immediately under all circumstances.
■The measurement system has to be checked to ensure the measurement function is operating
correctly at regular intervals. For further information about this, please see the Functional checks,
preparation, disposal [▶Page 24] chapter in these instructions for use.
■Do not install the jaw motion analysis system near a source of heat or in direct sunlight behind a
window, as excessive heating can lead to incorrect measurement results.
■Ensure that all power and connection cables are routed and protected so that nobody is able to trip
over them. Check all cables and connection plugs regularly for damage. Damaged power supply
units, plug connectors and cables must be replaced before further use.
■The measurement system is not protected against the penetration of fluids. If fluid penetrates the
measurement system, switch it off and please contact the SICAT GmbH & Co. KG technical service
team.
■Never introduce objects into components of the measurement system.
■Before starting every measurement, it is necessary to ensure the correct choice and correct position
of the transmitters or application aids. The cables or the application aids can present a risk of injury
to the patient. In this context, please consult the special instructions in the handbooks of the
application software, and do not allow children or mentally impaired patients to enter the proximity
of the device without supervision.
2.2.5 SAFETY INFORMATION ON HEART PACEMAKERS / DEFIBRILLATORS
■In the magnetic coupling for the attachment of the Lower jaw sensor type 24T on the Para-occlusal
attachment 90 there are strong permanent magnets, such as those that are used on headphones on
MP3 players. Under especially unfavorable circumstances, at short distances (< 15 cm), these
magnets can have a negative impact on the functionality of certain implanted heart pacemakers and
defibrillators. Therefore, the Lower jaw sensor type 24T should not be positioned on the upper body
of the patient on patients with electronic implants.
■Version BT devices contain a Bluetooth transmitter as an interface to the PC. Although there is so far
no evidence of a possible interference of heart pacemakers/defibrillators by Bluetooth transmitters,
the SICAT JMT⁺ system is not recommended to be used on patients with electronic implants using
the lanyard, but with the maintaining of a safety distance of at least 15 cm from the patient's
thorax.
■No interference of electronic implants is to be expected from the ultrasonic transmitters used in the
measurement system, as the SICAT JMT⁺ system works with airborne sound and a very low sound
power of a few milliwatts. Due to the adverse connection during the transition from the air into the
human body, the noise intensity of the measurement signals is weakened strongly such that any
interference with implants, as well as any damage to tissue, is excluded.

AREA OF USE AND SAFETY
Page 10 of 40 SICAT JMT⁺-Jaw motion analysis system
2.2.6 PROHIBITED USE
■Improper and/or prohibited use of the measurement system is not permitted and express warning is
herewith provided of such.
■Do not under any circumstances attempt to maintain or prepare the measurement system in any way
other than as described in the instructions for use. This could cause the high sensitivity sensor
technology to be in impaired terms of its measurement accuracy.
■In the case of malfunctions and/or defects being suspected and/or ascertained, the device has to be
taken out of use immediately, labelled as 'Out of Use', and secured to prevent use, with the on/off
switch being covered and secured with adhesive tape.
■Changing or modifying the measurement system or its accessory parts without the written
permission of SICAT is not allowed. If the device is changed without permission, the operator is
obliged to carry out suitable examinations and inspections in order to guarantee the secure use.
■SICAT measurement systems must not be operated in environmental conditions other than those
stated in the Technical data of the SICAT JMT ⁺ measurement system [▶Page 11] chapter (e.g. in an
oxygen enriched environment, wet zones, damp rooms, climactic chambers, low pressure-, high
pressure-, or altitude chambers, etc.).

PRODUCT DESCRIPTION
SICAT JMT⁺-Jaw motion analysis system Page 11 of 40
3 PRODUCT DESCRIPTION
3.1 SYSTEM COMPONENTS
In the basic configuration, the SICAT JMT+ system consists of the following components:
■SICAT JMT⁺ basic unit
■Lower jaw sensor type 24T (transmitter)
■Facebow type 13R (receiver)
■USB power supply for supplying the measurement system for BT devices
■USB adapter for SICAT JMT⁺ (type A to bayonet connector, 3 m in length)
■SICAT JMT⁺ application software
3.2 TECHNICAL DATA OF THE SICAT JMT⁺ MEASUREMENT
SYSTEM
VERSION SICAT JMT⁺ BT
Dimensions (W x H x D) 111 x 86 x 31 mm
Weight 205 g
Power supply 5V DC / 1W (USB to charge battery)
Battery yes
Measurement range 60 - 120 mm
Ultrasonic frequency 40 kHz
Max. measurement rate 50 Hz
Positioning accuracy in the occlusal area ± 0.1 mm (y); ± 0.2 mm (x, z)
Interface USB
Bluetooth yes

PRODUCT DESCRIPTION
Page 12 of 40 SICAT JMT⁺-Jaw motion analysis system
3.3 MEASUREMENT PRINCIPLE OF THE SICAT JMT⁺ JAW
MOTION ANALYSIS SYSTEM
The jaw motion analysis system consists of the Lower jaw sensor type 24T and the ultrasonic receiver
module on the Facebow type 13R. The sensor technology components of the receiver and transmitter
modules are each attached in geometrically defined positions. The marking points consist of small,
sequentially operated ultrasonic transmitters. The accompanying facebow consists of six ultrasonic
microphones. Both modules are connected with the evaluation electronics in the SICAT JMT⁺ basic unit
via a connecting cable.
During operation, the ultrasonic transmitters continuously emit impulses, from the operating time of
that, between the transmitter and receiver microphones, the evaluation electronic calculates the
absolute room coordinates of the markers using a triangulation method.
The calculation of the measurement coordinates and further measurement parameters, as well as the
compensation of the disturbance variables, occurs on a PC-supported basis in the evaluation programs.
BLOCK DIAGRAM OF THE MEASUREMENT SYSTEM

PRODUCT DESCRIPTION
SICAT JMT⁺-Jaw motion analysis system Page 13 of 40
3.4 CONTROL ELEMENTS AND CONNECTIONS
VIEW FROM FRONT
1
2
Facebow type 13R
Lower jaw sensor type 24T
VIEW FROM SIDE
1
On/off switch
VIEW FROM ABOVE
1
2
3
4
5
Bluetooth (blue)
Operating display (green)
Measurement (orange)
Power supply/battery (yellow)
IR-sync

PRODUCT DESCRIPTION
Page 14 of 40 SICAT JMT⁺-Jaw motion analysis system
VIEW FROM BELOW
1
2
Bracket for white lanyard
Name plate

PRODUCT DESCRIPTION
SICAT JMT⁺-Jaw motion analysis system Page 15 of 40
3.5 MEANING OF THE DISPLAY LIGHTS
LED ON/OFF SWITCH MEANING
Green / operational status indicator
off 0 (off) The measurement system is
NOT in operation
lit up I (on) The measurement system is in
operation
Orange / measurement
off I (on) The measurement system is ini-
tialized and is ready for meas-
urement.
flashes I (on) The measurement system is
waiting for initialization, meas-
urement not possible yet.
lit up I (on) The measurement has started /
ultrasonic transmitters are act-
ive.
Yellow / battery charging status
off I (on) USB adapter for SICAT JMT⁺
and/or USB power supply con-
nected, reduced charging as
soon as charging status > 95%
flashes 0 (off) USB adapter for SICAT JMT⁺
and/or USB power supply con-
nected, battery charging, char-
ging status < 95%
I (on) Battery level critical < 20%
Connect the USB adapter for
SICAT JMT⁺ or USB power sup-
ply immediately, as it is pos-
sible that data will be lost if the
measurement is continued.
lit up 0 (off) USB adapter for SICAT JMT⁺
and/or USB power supply con-
nected, battery fully charged,
charging status 100%
Blue / Bluetooth connection

PRODUCT DESCRIPTION
Page 16 of 40 SICAT JMT⁺-Jaw motion analysis system
LED ON/OFF SWITCH MEANING
off I (on) The measurement system is ini-
tialized and is ready for meas-
urement.
lit up I (on) The measurement has started /
the measurement system is
connected with the PC via
Bluetooth
3.6 ASSIGNMENT OF THE CONNECTING SOCKETS
LOWER JAW SENSOR TYPE 24T / DIGITAL INPUT (LIGHT GREEN)
SIGNAL PIN
Marker 1 Pin 1
Marker 2 Pin 2
Marker 3 Pin 3
Marker 4 Pin 4
SSWBus Pin 5
n.c. Pin 6
SDA (I²C) Pin 7
Signal Pin
SCL (I²C) Pin 8
+3.3Volt Pin 9
DRY_A Pin 10
DRY_G Pin 11
Dig. Input Pin 12
GND Pin 13
GND Pin 14

PRODUCT DESCRIPTION
SICAT JMT⁺-Jaw motion analysis system Page 17 of 40
FACEBOW TYPE 13R / DIGITAL INPUT (WHITE)
SIGNAL PIN
Microphone 1 Pin 1
Microphone 2 Pin 2
Microphone 3 Pin 3
Microphone 4 Pin 4
SSWBus Pin 5
Mic-select Pin 6
SDA (I²C) Pin 7
SCL (I²C) Pin 8
+3.6 - 12Volt Pin 9
DRY_A Pin 10
DRY_G Pin 11
Dig. Input Pin 12
GND Pin 13
GND Pin 14

PRODUCT DESCRIPTION
Page 18 of 40 SICAT JMT⁺-Jaw motion analysis system
3.7 ACCESSORIES AND SPARE PARTS
NAME FIGURE
SICAT JMT⁺ basic unit
for battery operation with Bluetooth interface
Facebow type 13R
for SICAT JMT⁺ basic unit
Complete with Nasion support, Elastic neckband white, and Headband
white
Nasion support
suitable for Facebow type 13R
Bearing seat
suitable for Facebow type 13R
Bearing cushion gray
suitable for Bearing seat
Packaging unit 5 pieces
Nose cushion gray
Packaging unit 5 pieces
Elastic neckband white
Packaging unit 5 pieces

PRODUCT DESCRIPTION
SICAT JMT⁺-Jaw motion analysis system Page 19 of 40
NAME FIGURE
Headband white
Lanyard white
Lower jaw sensor type 24T
for SICAT JMT⁺ basic unit
Para-occlusal attachment 90
for attachment to the front teeth
L = 60 mm / W = 90 mm, medical steel, sterilizable
SICAT Fusion Bite
made from LEXAN, suitable for gas and steam sterilization
Hint: single use item, not intended for multiple use
SICAT Fusion Bite Adapter
for attachment of the Lower jaw sensor type 24T to the SICAT Fusion Bite
USB power supply
for charging the SICAT JMT⁺ basic unit

PRODUCT DESCRIPTION
Page 20 of 40 SICAT JMT⁺-Jaw motion analysis system
NAME FIGURE
EU - Adapter USB power supply
UK - Adapter USB power supply
USA - Adapter USB power supply
Australia - Adapter USB power supply
World - Adapter USB power supply
USB adapter for SICAT JMT⁺
Data connection of measurement system and PC
SICAT JMT⁺ USB card
Medium that contains the SICAT JMT⁺ software