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Summary of Contents for SICAT JMT+
- Page 1 SICAT JMT ⁺ JAW MOTION ANALYSIS SYSTEM Technical data and instructions for use – English...
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Page 2: Table Of Contents
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 ........................ - Page 3 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 ............
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Page 4: User Information
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. -
Page 5: Used Symbols
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. SICAT JMT⁺-Jaw motion analysis system Page 5 of 40... -
Page 6: Area Of Use And Safety
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 ■... -
Page 7: Sicat Data Export
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... -
Page 8: Obligations Of The User
– 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. -
Page 9: Safety Information On Heart Pacemakers / Defibrillators
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. -
Page 10: Prohibited 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.). -
Page 11: Product Description
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... -
Page 12: Measurement Principle Of The Sicat Jmt⁺ Jaw Motion Analysis System
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. -
Page 13: Control Elements And Connections
3.4 CONTROL ELEMENTS AND CONNECTIONS VIEW FROM FRONT Facebow type 13R Lower jaw sensor type 24T VIEW FROM SIDE On/off switch VIEW FROM ABOVE Bluetooth (blue) Operating display (green) Measurement (orange) Power supply/battery (yellow) IR-sync SICAT JMT⁺-Jaw motion analysis system Page 13 of 40... - Page 14 PRODUCT DESCRIPTION VIEW FROM BELOW Bracket for white lanyard Name plate Page 14 of 40 SICAT JMT⁺-Jaw motion analysis system...
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Page 15: Meaning Of The Display Lights
< 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⁺... -
Page 16: Assignment Of The Connecting Sockets
Pin 5 n.c. Pin 6 SDA (I²C) Pin 7 Signal SCL (I²C) Pin 8 +3.3 Volt Pin 9 DRY_A Pin 10 DRY_G Pin 11 Dig. Input Pin 12 Pin 13 Pin 14 Page 16 of 40 SICAT JMT⁺-Jaw motion analysis system... - Page 17 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 Pin 13 Pin 14 SICAT JMT⁺-Jaw motion analysis system Page 17 of 40...
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Page 18: Accessories And Spare Parts
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... - Page 19 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 SICAT JMT⁺-Jaw motion analysis system...
- Page 20 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 Page 20 of 40 SICAT JMT⁺-Jaw motion analysis system...
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Page 21: Putting The Measurement System Into Operation
4.1 POWER SUPPLY AND CHARGING THE BATTERY For the rapid charging of the battery of the SICAT JMT⁺ basic unit when it is in the deactivated state, connect the USB power supply with an AC outlet and a USB cable with the USB socket on the SICAT JMT⁺... -
Page 22: Computer Requirements
SICAT JMT⁺ system and the PC. If no corresponding SICAT JMT⁺ software is installed on the PC yet, the mapping of the driver will fail for the above reasons, and the SICAT JMT⁺ system may not function correctly. -
Page 23: Connecting The Accessory Parts
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⁺ basic unit off and decouple the USB connection from the PC or USB power supply. Next, unplug the USB power supply from the socket. -
Page 24: Functional Checks, Preparation, Disposal
5.1 SPECIFIED REGULAR CHECKS AND TECHNICAL SAFETY CHECKS SICAT GmbH & Co. KG does not specify any technical safety checks for the SICAT JMT⁺ system. ■ To maintain the proper status of the electrical operating equipment, it is necessary to carry out ■... -
Page 25: Checking The Measurement Function
These measurement results should correspond with the known values. When the sensors do not move, the SICAT JMT⁺ software should show an unmoving image of the ■ lower jaw. Possible deviations (spikes or jumps in the measurement curve in spite of unmoved markers, incorrect presentation of the lower jaw, etc.) indicate a faulty measurement and impair the... -
Page 26: Preparation Methods
Serial numbers of the SICAT JMT⁺ basic unit and Lower jaw sensor type 24T/Facebow type 13R ■ – The serial numbers are on the name plates on the rear of the SICAT JMT⁺ basic unit and/or on the cables for the Facebow type 13R and Lower jaw sensor type 24T. -
Page 27: Manual Disinfection
134 °C ± 1 °C and 2 bar (can be sterilized up to a max. of 138 °C). It is necessary to sterilize the following accessory parts: Para-occlusal attachment 90 ■ SICAT Fusion Bite ■ SICAT JMT⁺-Jaw motion analysis system Page 27 of 40... -
Page 28: Disposal
For this purpose, at the end of its useful life, the measurement system can be returned by the customer to SICAT GmbH & Co. KG, and will then be forwarded by SICAT at no extra cost and without reimbursement to the appropriate recycling companies. -
Page 29: Safety Standards And Classification Of The System
OTHER ELECTRICAL DEVICES (also see DIN EN 60601-1:2006, section 16 Medical Electrical Systems) The SICAT JMT⁺ system may only be connected with other electrical devices if they correspond with the requirements of DIN EN 60950 and/or DIN EN 60601-1, CAUTION or have been designated as compatible by SICAT GmbH &... -
Page 30: Environment Of The Patient / Test Person
Failure to comply can lead to the occurrence of dangerous leakage currents. The following components of the SICAT JMT⁺ system may only be used within the patient environment: SICAT JMT⁺ basic unit including sensor technology ■... -
Page 31: Electromagnetic Compatibility For Guidelines / Manufacturer Declaration
6.3 ELECTROMAGNETIC COMPATIBILITY FOR GUIDELINES / MANUFACTURER DECLARATION The SICAT JMT⁺ system satisfies the requirements of the EN 60601-1-2 standard. (Medical electrical devices - part 1-2: General concerning for safety including the key performance attributes - supplementary norm: Electromagnetic compatibility - requirements and tests). - Page 32 ± 1 kV differential The supply voltage quality should be to IEC 61000-4-5 mode mode that of a typical commercial or hospital environment. ± 2 kV common ± 2 kV common mode mode Page 32 of 40 SICAT JMT⁺-Jaw motion analysis system...
- Page 33 IEC 61000-4-6 Radiated RF 3 V/m 80 MHz to 3 V/m for 80 MHz to 800 MHz surges according 2.5 GHz to IEC 61000-4-3 for 800 MHz to 2.5 GHz SICAT JMT⁺-Jaw motion analysis system Page 33 of 40...
- Page 34 JMT range of products. b Over the frequency range of 150 kHz to 80 MHz, the frequency range should be lower than 3 V/m. Page 34 of 40 SICAT JMT⁺-Jaw motion analysis system...
- Page 35 NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all cases. Electromagnetic propagation is affected by ab- sorption and reflection from buildings, objects and people. SICAT JMT⁺-Jaw motion analysis system Page 35 of 40...
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Page 36: Glossary
GLOSSARY GLOSSARY SICAT JMT⁺ SICAT JMT⁺ records the motion of the lower jaw. Page 36 of 40 SICAT JMT⁺-Jaw motion analysis system... -
Page 37: Index
Assignment of the connecting sockets 16 Sterilization 27 Control elements and connections 13 Meaning of the display lights 15 Measurement principle of the SICAT JMT⁺ jaw motion analysis system 12 Disposal System components 11 Accumulators and batteries 28 Technical data of the SICAT JMT⁺ measurement Electronics 28... -
Page 38: 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 E-mail: info@sicat.com http://www.sicat.com Material number: 6467323 Change number: 120753 Page 38 of 40 SICAT JMT⁺-Jaw motion analysis system... - Page 40 STATE: 2015-08-24 CONTACT Software support Manufacturer SICAT GmbH & Co. KG SICAT GmbH & Co. KG Brunnenallee 6 Brunnenallee 6 53177 Bonn, Germany 53177 Bonn, Germany Telephone: +49 228 85469711 Fax: +49 228 85469799 E-Mail: softwaresupport@sicat.com http://www.sicat.com...
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