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
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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.