background image

AREA OF USE AND SAFETY

 

SICAT JMT

⁺ 

Jaw Motion Analysis System

Page 9 of 37

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
and preparation' chapter in this handbook.

■ 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 (e.g. feeler) 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.

SAFETY INFORMATION ON HEART PACEMAKERS / DEFIBRILLATORS

■ In the magnetic coupling for the attachment of the lower jaw (LJ) sensor on the T-attachment 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 LJ-sensor 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 neck strap, 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.

2.2.5

Summary of Contents for SICAT JMT BT

Page 1: ...Instructions for use English SICAT JMT JAW MOTION ANALYSIS SYSTEM...

Page 2: ...lysis system 11 3 4 Control elements and connections 12 3 5 Meaning of the display lights 14 3 6 Assignment of the connecting sockets 15 3 7 Accessories and spare parts 16 4 Putting the measurement sy...

Page 3: ...irective 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...

Page 4: ...ories such as the bite fork or infrared remote control Information concerning accessory components is limited to key safety and maintenance measures and or hygiene measures CAUTION The exact complianc...

Page 5: ...ectronic 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 Symbol for RF transmitters Bluetooth inter...

Page 6: ...des a mapping of the facial symmetry for the fitting of the denture In a functional preliminary examination any discoordinations and limitations of movement can be analyzed and documented The electron...

Page 7: ...ing 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 e...

Page 8: ...hird 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 manufac...

Page 9: ...ition of the transmitters or application aids The cables or the application aids e g feeler can present a risk of injury to the patient In this context please consult the special instructions in the h...

Page 10: ...nd 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 mo...

Page 11: ...x 86 x 31 mm Weight 205 g Power supply 5V DC 1W USB to charge battery Battery yes Measurement range 10 100 mm Ultrasonic frequency 40 kHz Max measurement rate 50 Hz Positioning accuracy in the occlusa...

Page 12: ...s 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...

Page 13: ...on Analysis System Page 13 of 37 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 VIEW FROM BELOW...

Page 14: ...t possible yet lit up I on The measurement has started ultrasonic transmitters are active Yellow battery charging status off I on USB cable and or charger connected reduced charging as soon as chargin...

Page 15: ...surement system is connected with the PC via Bluetooth ASSIGNMENT OF THE CONNECTING SOCKETS LJ SENSOR DIGITAL INPUT LIGHT GREEN SIGNAL PIN Marker 1 Pin 1 Marker 2 Pin 2 Marker 3 Pin 3 Marker 4 Pin 4 S...

Page 16: ...Pin 4 SSWBus Pin 5 Mic select Pin 6 SDA I C Pin 7 SCL I C 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 ACCESSORIES AND SPARE PARTS DESIGNATION FIGURE SICAT...

Page 17: ...uitable 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 Ne...

Page 18: ...steel sterilizable length 60mm Occlusal attachment made from LEXAN suitable for gas and steam sterilization Hint single use item not intended for multiple use Bite fork type SI made from LEXAN suitab...

Page 19: ...9 of 37 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 ada...

Page 20: ...C directly using a USB cable type A to B or type A to Mini B CAUTION Only connect the USB charger that is approved and supplied by SICAT and arrange the measurement system such that the plug for the p...

Page 21: ...nt system and PC with the USB cable and or via Bluetooth that you have installed the SICAT JMT software If this step is omitted problems can occur during the installation of the device driver as the W...

Page 22: ...ENT 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 measur...

Page 23: ...GULAR 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 i...

Page 24: ...em 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 ju...

Page 25: ...message e g Type A measurement started button B then clicked movement C then completed changed over to function D upon changing back the error message xyz was reported etc PREPARATION METHODS NOTICE A...

Page 26: ...d application time WARNING Due to the risk of possible mix ups chemicals that are required for the disinfection or cleaning must only be stored prepared and kept ready in their intended containers STE...

Page 27: ...e appropriate recycling companies Due to potentially dangerous substances that can often be found in electrical or electronic devices the improper handling of old devices can have a negative impact on...

Page 28: ...TH OTHER ELECTRICAL DEVICES also see DIN EN 60601 1 2006 section 16 Medical Electrical Systems CAUTION The SICAT JMT system may only be connected with other electrical devices if they correspond with...

Page 29: ...ement system plug connectors and the patient at the same time Failure to comply can lead to the occurrence of dangerous leakage currents The following components of the SICAT JMT system may only be us...

Page 30: ...ields can distort the correct measurements and or make them impossible The same applies to neighboring power cables and devices that do not have CE marking If operation is required in the immediate pr...

Page 31: ...ital environment Surges according to IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode The supply voltage quality should be that of a typical commercial or...

Page 32: ...the frequency of the transmitter Recommended safety distance Conducted RF surges according to IEC 61000 4 6 3 Veff 150 kHz to 80 MHz 3 Veff Radiated RF surges according to IEC 61000 4 3 3 V m 80 MHz...

Page 33: ...VICES AND THE MEASUREMENT SYSTEMS IN THE JMT RANGE OF PRODUCTS The measurement systems in the JMT range of products are intended for operation in an electromagnetic environment in which radiated RF in...

Page 34: ...Jaw Motion Analysis System 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 re...

Page 35: ...ting into operation 20 Putting out of operation 22 P Product description Accessories and spare parts 16 Assignment of the connecting sockets 15 Control elements and connections 12 Meaning of the displ...

Page 36: ...Motion Analysis System 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 numb...

Page 37: ...N GERMANY INFO SICAT COM WWW SICAT COM Manufacturer ARTIKELNR 6467323 NDERUNGSNR 000000 LAST UPDATE 02 18 2014 CONTACT SICAT GMBH CO KG BRUNNENALLEE 6 53177 BONN GERMANY T 49 0 228 854697 11 F 49 0 22...

Reviews: