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Table of Contents
Summary of Contents for Sirona SICAT JMT+
- Page 1 SICAT JMT JAW MOTION ANALYSIS SYSTEM Instructions for use – English...
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Page 2: Table Of Contents
Contents Contents 1 User information............................. 4 1.1 Manufacturer information............................4 1.2 Configuration of the operating instructions ......................4 1.3 Used symbols................................4 2 Area of use and safety ..........................6 2.1 Intended use ................................6 2.1.1 Use .................................. 6 2.1.2 SICAT data export ............................ - Page 3 Contents 6.1 Classification pursuant to appendix IX of the Directive 93/42/EEC ............... 28 6.2 Safety of electrical medical devices ........................28 6.2.1 Connection of the SICAT JMT⁺ measurement system with other electrical devices ....... 28 6.2.2 Environment of the patient / test person ....................29 6.3 Electromagnetic compatibility for guidelines / manufacturer declaration ............
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Page 4: User Information
USER INFORMATION USER INFORMATION MANUFACTURER INFORMATION SICAT GmbH & Co. KG Brunnenallee 6 53177 Bonn Germany Telephone +49 (0)228 / 854697-11 Email: softwaresupport@sicat.com Internet: www.sicat.com CONFIGURATION OF THE OPERATING INSTRUCTIONS The operating instructions for the SICAT JMT⁺ jaw motion analysis system consist of two parts: 1. - Page 5 USER INFORMATION Symbol for manufacturer and date of manufacture Type BF device corresponding to DIN EN 60601-1 USB connection 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.
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Page 6: Area Of Use And Safety
AREA OF USE AND SAFETY AREA OF USE AND SAFETY 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: ■... -
Page 7: Sicat Data Export
AREA OF USE AND SAFETY 2.1.2 SICAT DATA EXPORT 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. A connecting cup serves as an interface for the referencing. -
Page 8: Obligations Of The User
AREA OF USE AND SAFETY 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. -
Page 9: Safety Information On Heart Pacemakers / Defibrillators
AREA OF USE AND SAFETY 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. -
Page 10: Prohibited Use
AREA OF USE AND SAFETY 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 operating instructions. -
Page 11: Product Description
PRODUCT DESCRIPTION PRODUCT DESCRIPTION SYSTEM COMPONENTS In the basic configuration, the SICAT JMT system consists of the following components: ■ JMT system basic unit ■ Lower jaw sensor (transmitter) ■ Head bow (receiver) ■ USB charger for supplying the measurement system for BT devices ■... -
Page 12: Control Elements And Connections
PRODUCT DESCRIPTION ultrasonic transmitters. The accompanying head bow consists of six and/or eight ultrasonic microphones. Both modules are connected with the evaluation electronics in the SICAT JMT measurement system via a connecting cable. During operation, the ultrasonic transmitters continuously emit impulses, from the operating time of which, between the transmitter and receiver microphones, the evaluation electronic calculates the absolute room coordinates of the markers using a triangulation method. - Page 13 PRODUCT DESCRIPTION VIEW FROM SIDE On/off switch VIEW FROM ABOVE Bluetooth (blue) Operating display (green) Measurement (orange) Power supply/battery (yellow) IR-sync VIEW FROM BELOW Bracket for neck strap Name plate SICAT JMT⁺ Jaw Motion Analysis System Page 13 of 37...
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Page 14: Meaning Of The Display Lights
PRODUCT DESCRIPTION MEANING OF THE DISPLAY LIGHTS ON/OFF SWITCH MEANING Green / operational status indicator 0 (off) The measurement system is NOT in operation lit up I (on) The measurement system is in operation Orange / measurement I (on) The measurement system is initializing and ready for measurement. -
Page 15: Assignment Of The Connecting Sockets
PRODUCT DESCRIPTION ON/OFF SWITCH MEANING lit up I (on) The measurement has started / the measurement system is connected with the PC via Bluetooth ASSIGNMENT OF THE CONNECTING SOCKETS LJ SENSOR / DIGITAL INPUT (LIGHT GREEN) SIGNAL Marker 1 Pin 1 Marker 2 Pin 2 Marker 3... -
Page 16: Accessories And Spare Parts
PRODUCT DESCRIPTION HEAD BOW /DIGITAL INPUT (WHITE) SIGNAL 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... - Page 17 PRODUCT DESCRIPTION DESIGNATION FIGURE Nose pads suitable for all head bows Support plate suitable for all head bows Support pad white suitable for support plates Packaging unit 5 pieces Nose pad white Packaging unit 5 pieces Rear headband white Packaging unit 5 pieces Top headband white Neck strap LJ sensor type 24T...
- Page 18 PRODUCT DESCRIPTION DESIGNATION FIGURE Para-occlusal attachment 90 for attachment to the front teeth L = 60 mm / W = 90 mm, medical steel, sterilizable Occlusal adapter for attachment of the LJ-sensor to the occlusal attachment Medical steel, sterilizable, length = 60mm Occlusal attachment made from LEXAN, suitable for gas and steam sterilization Hint: single use item, not intended for multiple use...
- Page 19 PRODUCT DESCRIPTION DESIGNATION FIGURE EU - Adapter USB power supply unit UK - Adapter USB power supply unit USA - Adapter USB power supply unit Australia - Adapter USB power supply World - Adapter USB power supply USB adapter for SICAT JMT⁺ Data connection of measurement system and PC SICAT JMT⁺...
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Page 20: Putting The Measurement System Into Operation
PUTTING THE MEASUREMENT SYSTEM INTO OPERATION PUTTING THE MEASUREMENT SYSTEM INTO OPERATION For the commissioning of the jaw motion analysis system, a USB cable of type A to Mini-B, as well as the installation CD are required with the SICAT JMT application software. -
Page 21: Installing The Sicat Jmt⁺ Software
PUTTING THE MEASUREMENT SYSTEM INTO OPERATION SICAT is unable to accept any liability for damage or functional errors that are caused by faulty software installation or unsuitable computer hardware. If the operator installs additional hardware or third party software, this occurs based CAUTION on the sole responsibility of the operator and is not covered by the manufacturer's liability. -
Page 22: Taking The Measurement System Out Of Operation
PUTTING THE MEASUREMENT SYSTEM INTO OPERATION TAKING THE MEASUREMENT SYSTEM OUT OF OPERATION To take the measurement system out of operation, please start by connecting the SICAT JMT software, shutting the PC down, and switching it off. Next, switch the SICAT JMT measurement system off and decouple the USB connection from the PC or charger. -
Page 23: Functional Checks, Preparation, Disposal
FUNCTIONAL CHECKS, PREPARATION, DISPOSAL FUNCTIONAL CHECKS, PREPARATION, DISPOSAL ■ Regular maintenance and care of the measurement system helps to prevent damage and guarantees its long-term safety. All of the procedures stated in these operating instructions regarding the maintenance and preparation of the system are to be carried out on a regular basis. ■... -
Page 24: Checking The Measurement Function
FUNCTIONAL CHECKS, PREPARATION, DISPOSAL CHECKING THE MEASUREMENT FUNCTION To guarantee long-term patient safety, the SICAT JMT system has to be inspected at regular intervals to ensure its proper measurement function. After hard knocks, such as if the head bow or LJ-sensor should fall on the floor, it CAUTION is necessary to check the measurement function immediately. -
Page 25: Preparation Methods
FUNCTIONAL CHECKS, PREPARATION, DISPOSAL CHECK LIST FOR THE RECORDING OF ERROR MESSAGES To be able to provide you with the optimum support in the case of operational NOTICE faults to your SICAT JMT system, our service team employees require the following information: ■... -
Page 26: Manual Disinfection
FUNCTIONAL CHECKS, PREPARATION, DISPOSAL 5.4.2 MANUAL DISINFECTION The measurement system can be wipe-disinfected with suitable solutions. Disinfect all components with a cloth that has been dampened with a disinfectant solution. Do not use any spray disinfectants on the head bow or the LJ-sensor! CAUTION Spray disinfectants destroy the high accuracy measurement sensors. -
Page 27: Disposal Of Electronic Waste
FUNCTIONAL CHECKS, PREPARATION, DISPOSAL 5.5.2 DISPOSAL OF ELECTRONIC WASTE The adjacent symbol shows that pursuant to the EC 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. -
Page 28: Safety Standards And Classification Of The System
SAFETY STANDARDS AND CLASSIFICATION OF THE SYSTEM SAFETY STANDARDS AND CLASSIFICATION OF THE SYSTEM CLASSIFICATION PURSUANT TO APPENDIX IX OF THE DIRECTIVE 93/42/EEC The system is classified as a medical product of Class I with a measuring function. SAFETY OF ELECTRICAL MEDICAL DEVICES The device fulfils the requirements of the DIN EN 60601-1:2006 standard. -
Page 29: Environment Of The Patient / Test Person
SAFETY STANDARDS AND CLASSIFICATION OF THE SYSTEM 6.2.2 ENVIRONMENT OF THE PATIENT / TEST PERSON In practice, an experience value with a clearance of 1.5 m from the patient has proven effective for the determination of the patient environment. When operating the system, the user [2] must make sure that they never touch the PC [3] and the patient [1] at the same time. - Page 30 SAFETY STANDARDS AND CLASSIFICATION OF THE SYSTEM Benzstrasse 1A 85551 Kirchheim Detailed information on EMC values and manufacturer data is provided in the tables for this handbook chapter. Medical electrical devices are subject to special safety measures regarding EMC (electromagnetic compatibility) and have to be installed and put into operation pursuant to the instructions provided below.
- Page 31 SAFETY STANDARDS AND CLASSIFICATION OF THE SYSTEM GUIDELINES AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC INTERFERENCE IMMUNITY The measurement systems in the JMT range of products are intended for operation in the electromagnetic environment stated below. The customer or user of the JMT measurement system should ensure that it is used in such an environment.
- Page 32 SAFETY STANDARDS AND CLASSIFICATION OF THE SYSTEM GUIDELINES AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC INTERFERENCE IMMUNITY The measurement systems in the JMT range of products are intended for operation in the electromagnetic environment stated below. The customer or user of the JMT measurement system should ensure that it is used in such an environment.
- Page 33 SAFETY STANDARDS AND CLASSIFICATION OF THE SYSTEM GUIDELINES AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC INTERFERENCE IMMUNITY a The field strengths of fixed transmitters, such as base stations for radio telephones and land mobile radios, amateur radio, AM and FM radio broadcasters and TV broadcasters, cannot be theoretically predicted with accuracy.
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Page 34: Glossary
GLOSSARY GLOSSARY Bite fork A bite fork is a bite plate with radiopaque spherical markers that is used to match 3D X-ray data with jaw motion tracking data. SICAT JMT⁺ The SICAT JMT⁺ records the motion of the lower jaw. Page 34 of 37 SICAT JMT⁺... -
Page 35: Index
INDEX INDEX Cleaning Product description Manual cleaning Accessories and spare parts Manual disinfection Assignment of the connecting sockets Sterilization Control elements and connections Meaning of the display lights Measurement principle of the SICAT JMT⁺ jaw motion analysis system Disposal System components Accumulators and batteries Technical data of the SICAT JMT⁺... -
Page 36: Contact
CONTACT CONTACT Manufacturer SICAT GmbH & Co. KG Brunnenallee 6 53177 Bonn, Germany Telephone: +49 (0)228 / 85497-0 Fax: +49 (0)228 / 854697-99 Email: info@sicat.com http://www.sicat.com Item code number: 6467323 Change number: 000 000 Page 36 of 37 SICAT JMT⁺ Jaw Motion Analysis System... - Page 37 LAST UPDATE: 02-18-2014 CONTACT Manufacturer SICAT GMBH & CO. KG BRUNNENALLEE 6 53177 BONN, GERMANY T +49 (0)228 / 854697-11 F +49 (0)228 / 854697-99 INFO@SICAT.COM WWW.SICAT.COM SICAT GMBH & CO. KG ■ BRUNNENALLEE 6 ■ 53177 BONN, GERMANY ■ INFO@SICAT.COM ■ WWW.SICAT.COM...
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