zebris JMAnalyser
Contents
1. Head bow Foot pedal Lower jaw sensor USB Mini Bluetooth Measurement Operating dis blue orange play green e On Off Switch IR Sync Power supply battery yellow Bracket for neck strap 1 4 inch tripod connection Name plate USB standard zebris Medical GmbH JMAnalyser Technische Daten und Gebrauchsanweisung Seite 14 38 3 5 Meaning of the Display lights LED ON OFF Switch Meaning The measurement system is NOT in operation The measurement system is in O gt operation The measurement system is initializing and ready for measurement The measurement system is waiting for initialization measurement not possible yet The measurement has started ultrasonic transmitters are active O O gt gt lt O gt USB cable and or charger on connected reduced charging as soon as charging status gt 95 0 off USB cable and or charger connected battery charging charging status lt 95 Battery level critical lt 20 Connect the USB cable or charger immediately as it is possible that data will be lost if m O gt lt the measurement is continued 0 off USB cable and or charger connected battery fully charged charging status 100 The measurement system Initializes and is ready for measurement The measurement has started the measurement system is connected with the PC via Bl2. 2 1 2 Articulators With the help of the zebris JMAnalyser system is it possible to adjust the following articu lators e Artex AR Girrbach Amann e KaVo PROTAR 7 e SAM e Stratos 300 lvoclar 2 1 3 Data Export The XML export function allows the use of determined jaw movements in CAD CAM sys tems and CBCT systems for functional optimization of dental restorations and occlusal splints As a reference for data matching serves a bite fork This bears reference marks which of imaging systems such as Surface scanner or DVT can be detected zebris Medical GmbH JMAnalyser Technische Daten und Gebrauchsanweisung Seite 7 38 2 2 Safety 2 2 1 Environmental conditions The JMAnalyser jaw motion analysis system is suitable for use in dry interior rooms as can be found in clinics medical practices and laboratories Temperature range 10 C to 40 C Relative humidity 30 to 70 The Jaw motion systems must NOT be operated in wet zones wet rooms swimming pools saunas or climatic chambers The measuring systems are not intended for operation in potentially explosive atmospheres of medically used rooms or oxygen enriched atmospheres The devices must not be operated in proximity to e g engines or AN transformers with a high connected load as well as mains current WARNING lines as electrical or magnetic interference fields can falsify correct measurements resp turn them impossible To avoid reciprocal faults from occurring
3. or al titude chambers etc zebris Medical GmbH JMAnalyser Technische Daten und Gebrauchsanweisung Seite 11 38 3 Product description 3 1 System components In its basic configuration the JMAnalyser measuring system consists of the following components e JMAnalyser system basic unit e Lower jaw sensor Transmitter e Head bow Receiver e USB charger for supplying the measurement system for BT devices e USB cable adapter e zebris DENTAL application software e IBM compatible computer or notebook e Zubeh r IR Fernbedienung Zeigerstift Kopplungsl ffel Attachments e User Manual for system and software equipment and application software 3 2 Technical data of the JMAnalyser measurement system Version REF Dimensions W x H x D Weight Power supply Battery Measurement range Ultrasonic frequency Max measurement rate Positioning accuracy in the occlusal area accuracy articulator ang USB Schnhittstelle Bluetooth analog connectors analog measurement area analog measurement rate zebris Medical GmbH JMAnalyser 1160010 145 x 85 x 35 mm 160 g 5V DC 1W USB no 51 300 mm 40 kHz 50 Hz 0 1 mm y 0 2 mm x z les 2 0 USB mini USB Standard no 2 2 5V resolution of 12 Bit 100 s per canal JMAnalyser Technische Daten und Gebrauchsanweisung JMAnalyser BT 1160015 145 x 85 x 35 mm 205 g 5V DC 1W USB to charge battery yes 51 300 mm
4. KONFOBMITATSEBKLARUNG east of 7 DA E 38 zebris Medical GmbH JMAnalyser Technische Daten und Gebrauchsanweisung Seite 2 38 1 User Notes 1 1 Introduction Welcome to the User Manual for Jaw Motion Analysis This User Manual provides a basic understanding for operating the JMAnalyser measur ing system for the contact free analysis of all the 3D movements of the lower jaw using the method for measuring the travel time of ultrasound pulses It explains the basic set up and operation of the system and provides tips on preparation for measuring and data acquisition Technical information on the system and safety precautions can be found in this technical User Manual All particulars about the measurement system in this book were prepared compiled and edited with the greatest of care Nevertheless we cannot guarantee that mistakes do not appear We advise the user that zebris Medical GmbH neither provides a guarantee against nor accepts any legal responsibility or any liability for consequences resulting from incorrect statements The company zebris Medical GmbH does not assume any liability whatsoever for injury to personnel or patients or damage to the device caused by improper use of the JMAnalyser System If you notice any mistakes in this manual or should you have any suggestions for the improvement we would be very grateful for giving us a short message any time In the interests of continuous product development the manufactu
5. defects being suspected and or ascertained the device has to be taken out of use immediately labeled as Dut of Used and secured to prevent use The manufacturer or authorized sales partner must always be contacted in all cases of fault or doubt e The measuring system must be checked at regular intervals to make sure it is func tioning properly More details on this can be found in the section Maintenance of the Device in this User Manual e 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 e Be sure that all the mains and connection cables are laid safely and that they are pro tected against stepping on so that nobody can trip over them Check all the cables and the connection plug regularly for any damage Damaged power Supply and ca bles have to be replaced before further operation e The measurement system is not protected against the penetration of fluids If fluid penetrates the measurement system switch it off and please contact the zebris Medi cal GmbH technical service team e Never introduce objects into components of the measurement system e 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 Pointer can present a risk of injury to the patient In this context please con
6. few millimeters Due to the adverse connection during the transition from the air into the human body the noise intensity of the meas urement signals is weakened strongly such that any interference with implants as well as any damage to issue is excluded 2 2 6 Prohibited Use e Improper and or prohibited use of the measurement system is not permitted an ex press warning is herewith provided of such e Do not under any circumstances attempt to maintain or prepare the measurement sys tem in any way other than as described in the operating instructions This could cause the high sensitivity sensor technology to be in impaired terms of its measurement ac curacy e In the case of malfunctions and or defects being suspected and or ascertained the device has to be taken out of use immediately labeled as Mut of Used and secured to prevent use with the on off switch being covered and secured with adhesive tape e Changing or modifying the measurement system or its accessory parts without the written permission of zebris Medical 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 e zebris measurement systems must not be operated in environmental conditions other than those stated in the dechnical data chapter e g in an oxygen enriched environ ment wet zones damp rooms climatic chambers low pressure high pressure
7. from LEXAN suitable for gas and steam sterilization Hint single use item not intended for multiple use bite fork type SD made from LEXAN suitable for gas and steam sterilization Hint single use item not intended for multiple use Bite for adapter for attachment of the LJ sensor to the bite fork EMG DENTAL2N amplifier With N electrode amplification 1000 particularly small electrode contacts especially Suitable for the use in dental medicine Illustrations JMAnalyser Technische Daten und Gebrauchsanweisung Seite 19 38 REF No 126 0041 810 0020 181 0702 186 0010 3310 1110 3310 1115 3310 1117 3310 1116 3310 1118 3310 1119 800 0510 800 0220 720 0001 890 0510 zebris Medical GmbH Description EMG DENTAL2N amplifier Without N electrode amplification 1000 particularly small electrode contacts especially suitable for the use in dental medicine EMG double electrodes 1 pack a 25x8 pieces Note For single use only not designed for reuse Foot pedal for measuring systems JMAnalyser and JMAna lyser BT IR remote control for all JMAnalyser Messsysteme USBpower supply unit with country adapter For charging JMAnalyser BT 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 cable A B 3m long Data connection of measurement syst
8. mains Only connect the USB charger that is approved and supplied by USB charging power supply REF 3310 1110 information on the power supply unit checking that the voltage and frequency is consistent with the local data Only connect if such con NOTE sistency is given e i s Before connecting the charger to the mains consult the name plate vw Carry out a full visual inspection to the power supply unit power cable and plug as well as the protective contacts before the connection and or operation of the measurement system Damaged power supply units cables or plug connectors must be replaced immediately by an WARNING authorized person zebris Medical GmbH JMAnalyser Technische Daten und Gebrauchsanweisung Seite 21 38 4 2 Computer requirements As a rule the measuring system JMAnalyser is supplied together with a computer If the system is to be operated using other computers or components the user must then inquire whether the intended coupling guarantees the necessary safety for the test person the operator and the surroundings by consulting the manufacturer the authorized zebris sales partner or by asking a specialist Please refer to the zebris DENTAL Software Manual for informations according to PC re quirements lf the computer is not supplied with the measuring system the man ufacturer shall not be held liable for any damage or malfunctions arising from a faulty coupling Should additional har
9. of electromagnetic waves is influenced by absorption and the reflections of buildings objects and people The field strength of stationary transmitters such as the base stations of mobile phones and land mobile services ham radio stations AM and FM radio and TV broadcasters is theoretically not 100 predictable A site study is recommended to deter mine the electromagnetic environment as a result of stationary RF transmitters If the measured field strength at the site of the FDM T force distribution measuring system exceeds the compliance levels listed above the FDM T force distribution measuring system must be monitored to document its proper functionality at every place of application Additional measures might become necessary e g modifying the orientation or moving the location of the JMAnalyser jaw motion measuring system if unusual performance characteristics are observed The field strength is less than 3 V m for the frequency range of 150 kHz to 80 MHz Recommended Safety Distances between Portable and Mobile RF Telecommunications Devices and the JMAnalyser jaw motion measuring system The JMAnalyser jaw motion measuring system is intended for use in an electromagnetic environment where RF interference quanti ties are controlled The customer or user of the JMAnalyser jaw motion measuring system can contribute towards preventing electro magnetic emissions by complying with the minimum distance between portable and mobile RF telecommuni
10. only be carried out when the sys tem is switched off and the charger and or USB cable are unplugged and using a damp cloth zebris Medical GmbH JMAnalyser Technische Daten und Gebrauchsanweisung Seite 29 38 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 disinfection solution No spray disinfection AN Spray disinfection can destroy the highly precise WARNING measurement sensors of the platform Recommended disinfection agent Composition approx 25 ethanol 35 Propanol E g Mikrozid Liquid Sch lke amp Mayr or similar agents f If you apply disinfection agent be sure to follow the recommenda j tions given by the manufacturer of the disinfection agent strictly Es z pecially consider the rules concerning the commended application NOTE time of the agent Due to danger of confusion chemicals that are necessary for the ZN disinfection or cleansing exclusively must be stored prepared and provided in containers that are appropriate for this purpose WARNING 5 4 3 Sterilization All accessory parts that come into contact with the patient mucosa have to be sterilized before use The sterilization its o be completed immediately subsequent to the 8 cleaning NOTE Sterilize the bite fork and lower jaw attachment with a fractionated pre vacuum for four minutes at 134 C and 3 04 b
11. zebris DENTAL user manual of the application software The section JMAnalyser Specifications and Operating Instructions and user manual pri marily contains information on technical data and the operation of the JMAnalyser system sensor technology as well as on their safe operation Notes regarding the accessories are limited to essential safety and maintenance measures and hygiene procedures The exact adherence to the instructions in all sections of the operat ing Instructions for the measuring system is a precondition for its intended use WARNING zebris Medical GmbH JMAnalyser Technische Daten und Gebrauchsanweisung Seite 4 38 1 4 Conventions and Symbols Used zebris Medical GmbH ob PER Mm 13 z nk or S lt L O Lx 4 JMAnalyser Technische Daten und Gebrauchsanweisung The green markings in the margin of the User Manual denote new information about the product safety fWARNINGO symbols indicate a potential hazard to the health and safety of the users and or patients The warnings describe the risks involved and those can be avoided INOTEO symbols indicate a potential risk which could lead to damaging of the device These NOTE symbols describe the risks involved and how those can be avoided The CE mark on the type plate confirms the conformity of the measuring system with the Directive 73 23 EEC and Directive 89 366 EEC Low Voltage Directive and EMC Directive The CE mark with reference number
12. 0535 of notified body BSI formerly EUROCAT on the type plate confirms the conformity of the system with the Directive 93 42 EEC for Medical Devices symbol for manufacturer and date of production Device of type BF according to DIN EN 60601 1 symbol for the connection of the external power supply unit DC voltage 15 20V with indicated polarity USB Interface The symbol indicates that in accordance with the Directive 2002 96 EEC Waste Electronic and Electrical Equipment Di rective and national laws a product must not be disposed of in the household waste and that within Europe it has to be dis posed of in a special way Carefully read the accompanying documentation particularly all information concerning product safety Seite 5 38 2 Area of use and safety 2 1 Intended Use The zebris JMAnalyser system calculates from the recorded jaw movements of the patient all the necessary parameters with the objective of designing a functional prosthesis and splints The measuring system also allows the output of functional parameters for the pro gramming of virtual and mechanical articulators and export of data for further processing with CAD CAM or DVT systems Furthermore the system allows the therapeutic positioning of the mandible in a jaw rela tion The measuring system must only be used by trained dentists The application environment is limited to dental facilities A measurement is performed within 15 minutes and shou
13. 40 kHz 50 Hz 0 1 mm y 0 2 mm x z 2 0 USB mini USB Standard yes 2 2 5V resolution of 12 Bit 100 s per canal Seite 12 38 3 3 Measuring principle The jaw registration system includes the lower jaw sensor and the ultrasonic receiver module at the head bow as well as an foot pedal or an infra red remote control The sen sory components of the receiver and transmitter modules are mounted in each geometri cally defined position The markers consist of small ultrasonic transmitters which are oper ated sequentially The corresponding head bow contains eight ultrasonic microphones Both modules are connected via a cable to the transmitter in the JMAnalyser measure ment system In operation the ultrasonic transmitters provide continuous pulses From the ultrasonic transit time between the transmitter and receiver microphones the system calculates by means of an evaluation of a geometry triangulation method the absolute coordinates of the marker The calculation of the measured coordinates and other measurement parameters and the compensation of disturbances are supported by a PC in the evaluation programs Block diagram of the measurement system Digital section Analog T Interface Section HOS n protected area 4 POWER Sectionf zebris Medical GmbH JMAnalyser Technische Daten und Gebrauchsanweisung Seite 13 38 3 4 Control elements and Connectors analog right analog left
14. 8V Min signal duration in order to cause a triggering 1mS The digital input is set to 5V LN D with an internal pull up resistor By pulling this input up to OV An through a switch relay contact or similar the input is triggered 3 2 EMG for the determination of the muscle tone of the jaw muscles For the synchronous recording of the EMG data zebris offers EMG differential electrodes amplifier cables as an accessory that are optimally adjusted to the JMAnalyser system REF 126 0031 EMG DENTAL2N amplifier REF 126 0041 EMG DENTAL2 amplifier The EMG differential electrodes amplifier cables are directly connected to the JMAnalyser system and thanks to their particularly small electrode contacts are particularly suitable for the use in dental medicine The EMG data is evaluated in envelopes Please find further notes on the application of the EMG module in the zebris DENTAL software manual Connections for analogue amplifier cable Technical specifications analogue inputs Input resistance 10E 129 CMRR 110 dB Noise referring to the input signal 0 28 uV pp Bandwidth 7 Hz to 500Hz Output voltage power supply 1 V The EMG double electrodes REF 810 0020 are not reusable and t intended for single use only lf other EMG electrodes are used than those recommended by WARNING zebris the user shall bear sole responsibility for their biological compatibility zebris Medical GmbH JMAnalyser Technische Daten und Gebrauchsa
15. Jaw Motion Analysis System J MA Auger B zeoris Specifications and Operating Instructions zebris Medical GmbH www zebris de Text Release 24 07 2013 Inhalt 1 LS ER INO TES EEN 3 1 1 INTRODUCTION EE 3 1 2 MANUFACTURER AND SALE Se co eee eee 4 1 3 LAYOUT OF THE USER MANUAL FOR THE FDM Giwer 4 1 4 CONVENTIONS AND SYMBOLS Uercn 5 2 AREA OF USE AND SAFETY cccececececececececececececeneneneaeeceeeeeseceeeceeececececeaeaeaeaeaenececeaeeeeeeseees 6 2 1 INTENDED U E EEN 6 Ziel WU EE 6 2 122 ABTICUATOR eelerer eg 7 Puls NOAA Ke ORD H 7 2 2 EEN 8 222 1 ENVIRONMENTAL CONDITIONS eege leg 8 22 2 STORAGE AND E de EE 8 2 2 3 OBLIGATIONS OF THE RE 9 2 24 GENERAL SAFETY el Eug e 10 2 2 5 SAFETY INFORMATION ON HEART BACEMAKERSIDEEIBRILLATORS 11 2265 PROHIBITED Ee 11 3 PRODUCT DESCRIPTION cccccccecececeeeeeecececeeecececececececececeaeceneneneneneasaeececeeesececeaeaeaeaeaeaeaes 12 3 1 EH E Eeer EE 12 3 2 TECHNICAL DATA OF THE JMANALYSER MEASUREMENT SYS EM nasssannnnnennnnnnnnnnnnnrnnnrnnrrnnrrnnrrnne 12 3 3 WIEASURING PRINCIPE EE 13 3 4 CONTROL ELEMENTS AND GONNECTORS 4 22 25 25 ERA BE a ee ES EE ee 14 39 WIEANING OF THE DISPLAY LIGHT S sctcaniexcacscasicssasstacseacacasasaaasaaseace a E eases vee ah 15 3 6 ASSIGNMENT OF THE CONNECTING SOCKETS nenn anne nenn anne nenn nenne nn 16 3 1 DIEITAEINPUTS 22 eh een 17 3 2 EMG FOR THE DETERMINATION OF THE MUSCLE TONE OF THE JAW MUSCLES 17 3 3 ACCESSORIES A
16. ND SPARE PARTS eege eege 18 4 PUTTING THE MEASUREMENT SYSTEM INTO OPERATION 2 2cececececececececececeeeeeeeees 21 4 1 POWER SUPPLY AND CHARGING THE BATTERY ONLY JMANALYSER RI EN 4 2 COMPUTER RE OU IRE EIS EE 22 4 3 INSTALLING THE ZEBRIS DENTAL SOFTWARE a a a A ee 23 4 4 CONNECTING THE ACCESSORY PARTS a a EEE 23 4 5 CONNECTION OF THE BASIC UNIT VIA USRBINTEREACE 24 4 6 CONNECTION OF THE BASIC UNIT VIA BLUETOOTH INTERFACE 25 4 7 TAKING THE MEASUREMENT SYSTEM OUT OF OPERATION 25 5 CONTROL MEASURES PREPARATION DISPOSAL z202020000000n0n0 nan an an nn nn nn nun nn an ann 26 5 1 MANDATORY PERIODIC INSPECTIONS AND GI 26 5 2 CHECKING THE MEASUREMENT FUNCTION aasssnasnnnnnnnnnnanrnnrnnrnnrnnrnnrrnrranrrnnrnnrnnrnnrrnrrarrnrrnrrnnrnnnnt 27 5 3 TROUBEESHOOTING a est aan haar eee ere a a eee cen sera ra Ara oan dare deen teen dee ran kr ke arenes 28 5 4 PREPARATION NIE T HOD S Sr een 29 Beal REES 29 Bae REESEN 30 DA Sg REN TION EEN 30 5 6 DOPO EE 31 SON ee el Te 31 5 6 2 EENHEETEN SEENEN SES 31 6 SAFETY STANDARDS AND SYSTEM CLASSIFICATION cccccececeeeeeeeeeeeeceeeeeceeecenecenens 32 6 1 CLASSIFICATION ACC TO ANNEX IX OF DIRECTIVE OOAOIEEC 32 6 2 SAFETY OF MEDICAL ELECTRICAL DEVIGES eet ege EEN 32 6 2 1 CONNECTING THE JMANALYSER SYSTEM TO OTHER ELECTRICAL D NICES 32 622 VICINITVOR THE PATIENT TEST PERSON seen 33 6 3 ELECTROMAGNETIC COMPATIBILITY GUIDELINE amp MANUFACTURER DECLARATION 34 6 4
17. NOTE puter using the USB cable lf the platform is connected without installing the software before problems when installing the device driver may occur and the system does not work for the Windows operating sys tem registered in the initial connection of the JMAnalyser system and the PC the location of the driver on the hard disk If no corresponding zebris software installed on the PC yet the mapping of the driver will fail for the above reasons and the JMAnalyser system may not function correctly How to solve problems with the hardware driver Should problems with the hardware driver of the JMAnalyser system occur then disconnect the platform from the PC and restart it Now O proceed with installing the zebris DENTAL software another time NOTE and reconnect the platform when the installation procedure has been finalized 4 4 Connecting the accessory Parts Connect the head bow lower jaw sensor and possible foot switch with the corresponding colored socket on the measurement system Bitte beachten Sie beim Anschluss von Kopfbogen UK Sensor und l FuBschalter an das Messsystem dass die Stecker mittels Kodier e Nasen gegen Verpolung bzw Einstecken in der falschen Buchse gesch tzt sind Alle Stecker sollten stets leichtgangig und ohne gr NOTE Bere Krafteinwirkung in die Buchsen gleiten Next connect the measurement system and a USB interface on your computer with the USB cable provided or set up the Bluetooth
18. ar can be sterilized up to max of 138 C It is necessary to sterilize the following accessory parts e Para occlusal attachment 90 REF 196 0260 e Occlusal adapter REF 196 0271 e Occlusal attachment REF 196 0270 e Biteforke type SD REF 196 0320 zebris Medical GmbH JMAnalyser Technische Daten und Gebrauchsanweisung Seite 30 38 5 6 Disposal 9 6 1 Packaging All transport packaging amp delivered by zebris can be recycled within Germany via the local recycling depots In order to provide the reuse of the recyclable material contained in the packaging the zebris Medical GmbH takes part in the dual ZENTEK system that takes over the proper disposal of packaging 5 6 2 Disposal of electronics This symbol states that according to the directive on waste electri cal and electronic equipment 2012 19 EEC the product must not be disposed by means of the domestic waste system Within Eu rope this device must be forwarded to a specific waste disposal system Therefore regular disposal is carried out by the manufacturer For this purpose the system should be shipped to the manufacturer and will be forwarded to regular disposal by zebris The improper interaction with electronic waste could lead to nega tive effects for the environment and the public health because of potential hazardous materials which are frequently contained with in electric and electronic devices Additionally with the proper disposal of this product
19. atients 1 5m A WARNING zebris Medical GmbH JMAnalyser Technische Daten und Gebrauchsanweisung Seite 33 38 6 3 Electromagnetic compatibility Guideline amp Manufacturer Declaration The JMAnalyser system satisfies the requirements of the EN 60601 1 2 standard Medi cal electrical devices part 1 2 General concerning for safety including the key perfor mance attributes supplementary norm Electromagnetic compatibility requirements and tests Inspecting authority SCHWILLE 1 ELEKTRONIK Produktions und Vertriebs GmbH Benzstrasse 1A 85551 Kirchheim Detailed information on EMC values and information supplied by the manufacturer can be found in the tables in this Section of the User Manual Electrical equipment in the medical field is subject to particular precautionary measures as regards the EMC Electromagnetic Compatibility and must be installed and put into opera tion in accordance with the instructions given below A Even though the motion analysis system JMAnalyser fully complies N with the requirements of the standard EN 60601 1 it cannot be total ly excepted that portable and mobile RF communications equipment can affect the system If ever possible such devices should not be operated within the system environment during measurements WARNING The use of accessories particularly cables for connecting to the PC AN that are not supplied by zebris for use with the JMAnalyser system or explicitly recomme
20. cations devices transmit ters and the JMAnalyser jaw motion measuring system as recommended below in accordance with the maximum output power of the communication device Rated output of the Safety distance based on the transmitting frequency m transmitter W w 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz The safety distance for transmitters with a rated output not listed in the table above can be calculated by applying the formula corresponding to the respective column whereby P is the rated output of the transmitter in watts W as specified by the transmitter manufacturer NOTE 1 For calculating the recommended safety distance of transmitters in the frequency range of 80 MHz to 2 5 GHz an additional factor of 10 3 was used to reduce the probability of a mobile portable telecommunications device taken unintentionally into the patient s area causing interference NOTE 2 These guidelines may not be applicable in all situations The spread of electromagnetic waves is influenced by absorption and the reflections of buildings objects and people zebris Medical GmbH JMAnalyser Technische Daten und Gebrauchsanweisung Seite 36 38 6 4 Konformitatserklarung EG KONFORMITATSERKLARUNG 2 7e 0 dE EC DECLARATION OF CONFORMITY Medien EMER Hersteller manufacturer zebris Medical GmbH Max Eyth Weg 43 88316 Isny Deutschland Germany Wir erklaren in alleiniger Verantwortung dass We declare under our sole responsibili
21. connection In this context it is necessary to ensure that the measurement system is switched on Your measurement system is now ready to use Detailed instructions on the operation of the JMAnalyser system are provid ed in the operating instructions for the zebris DENTAL software zebris Medical GmbH JMAnalyser Technische Daten und Gebrauchsanweisung Seite 23 38 4 5 Connection of the basic unit via USB Interface If the measuring system is operated via USB interface the device is automatically recog nized by the zebris DENTAL software Wait until the hardware installation process has fin ished and the following massage appears zebris Coordinate Measurement System AD Die Ger tetreibersoftware wurde erfolgreich installiert Now the measuring system is ready for use and can be found in the software under device settings u Hardware Setup gt Check you hardware settings press OK when done To quickly switch bet Hardware Profile Default New Delete Selected Devices Delete Device X Configure Device For more information on installation please refer to the operating instructions for zebris DENTAL Software zebris Medical GmbH JMAnalyser Technische Daten und Gebrauchsanweisung Seite 24 38 4 6 Connection of the basic unit via Bluetooth interface Select the r8tartobutton on the desktop and then select Devices and printers g Paint TeamViewer 8 lt Computer J Kurznotizen Systemst
22. delines and Manufacturer s Statement Electromagnetic Interference Immunity The JMAnalyser jaw motion measuring system is intended for use in the electromagnetic environment described below The customer or user of the JMAnalyser jaw motion measuring system should ensure that it is operated in such an environment Interference immunity IEC 60601 Compliance Electromagnetic environment guidelines tests test levels level Portable and mobile wireless sets should not be used in closer prox imity to the JMAnalyser jaw motion measuring system including the cables than the recommended safety distance that is calculated on the basis of the formula suitable for the transmitting frequency Recommended safety distance quantities acc to IEC 61000 4 6 to 80 MHz Radiated RF interference quantities acc to IEC 80 MHz d 1 24 P 80 MHz to 800 MHz 61000 4 3 to 2 5 GHz li dal onmewaocn With P as the rated output of the transmitter in watts W according to the information provided by the manufacturer of the transmitter und d as the recommended safety distance in meters m The field strength from fixed RF transmitters as determined by an electromagnetic site survey is less than the compliance level in all the frequencies Interference is possible in the proximity of devices featuring the fol lowing pictograph The higher value applies in the case of 80 MHz and 800 MHz These guidelines may not be applicable in all situations The spread
23. dware be built ZN into the computer or software installed the manufacturer shall not be liable for any malfunctions or damage occurring WARN The computer must be CE marked and fulfil the requirements of DIN EN 60950 resp DIN EN 60601 1 The JMAnalyser measuring system is not designed for the operation within a network data network The connection of the system with a networtk data network can cause unforeseen risks for patients or third parties If the zebris DENTAL software shall be installed in a network data network the operator is obliged to determine analyse AN evaluate and control the risks that are connected with doing so particularly with regard to the aspects data protection virus security WARNING updates of the operating system and regular backups Risk consid erations have to include subsequent changes of the network data network like e g update upgrade of devices and components that are connected to the network zebris Medical GmbH JMAnalyser Technische Daten und Gebrauchsanweisung Seite 22 38 4 3 Installing the zebris DENTAL software lf your measuring system is delivered without PC laptop please install the application software before connecting the measuring system to the computer Please find information on the installation in the user manual of the zebris DENTAL software i Please make absolutely sure that you have installed the zebris e software before connecting the JMAnalyser system to the com
24. em and PC Bluetooth USB Stick mit Plug and Play Funktion zebris DENTAL Software for operation system Windows 7 32 64 Bit Download of Updates from zebris Service Cen ter http www zebris de deutsch extranet User Manual Printing version is liable to be charged Free download of PDF Files from zebris Service Center http www zebris de deutsch extranet Illustrations DK NZ JMAnalyser Technische Daten und Gebrauchsanweisung Seite 20 38 4 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 is required with the JMAnalyser application software All components are included in the scope of delivery for the JMAnalyser system 4 1 Power supply and charging the battery only JMAnalyser BT For the rapid charging of the battery of the SICAT JMT measurement system when it Is in the deactivated state connect the charger with an AC outlet and a USB cable of type A to Mini B with the Mini USB socket on the measurement system Alternatively the measurement system can also be charged or operated directly on the USB socket of a PC To do this connect the PC directly using a USB cable type A to B or type A to Mini B SICAT and arrange the measurement system such that the plug for the power socket is easily accessible at all times and the device can WARNING be easily disconnected from the
25. es the analysis of TMJ sounds by means of highly sensitive in the joint area placed borne noise microphones and functional tests of various muscle groups such as temporalis anterior and masseter The XML export function allows the use of the determined jaw movements in CAD CAM systems and CBCT systems for functional optimization of dental restorations and occlusal Splints zebris Medical GmbH JMAnalyser Technische Daten und Gebrauchsanweisung Seite 6 38 The zebris JMAnalyser system is used to support the functional diagnosis The measuring sensor consists of a receiver and a transmitter It is attached to the patient s head The lower jaw sensor is equipped with a special locking mechanism for the attachment The face bow is put forward by means of support on the nasion and applied to the back of the head above the ears A measurement can then be carried out according to the desired settings and measured parameters on the software All measuring and analytical results of the zebris JMAnalyser system should always be interpreted in the light of the clinical history of the patient and in the context of other diag nostically methods of a demonstrably trained person and examined for relevance If inva sive 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 result alone
26. euerung x Snipping Tool Ger te und Drucker lt XPS Viewer Standardprogramme E WinJAW_JMAanalyser_BT Hilfe und Support E WinJaw gt Alle Programme erfahren ga Under Control Panel gt Devices and Printerso you will find the button Mdd de viceaThrough the recognition of the 160015 zebris JMAnalyser othis device can now be paired with your PC and added to the bluetooth capable systems 4 Ger te 3 aa gt Systemsteuerung Hardware und Sound Ger te und Drucker m Ger t hinzuf gen Drucker hinzuf gen e m Diesem Computer ein Drahtlos oder 4 Druck Netzwerkger t hinzuf gen l 7 CH K 4 d 1160010 oe Watebook Ga IMAnak Dienste ical Mouse Verkn pfung erstellen Problembehandlung Ger t entfernen Eigenschaften Kategorie Andere When clicking on the JMAnalyser symbol it is highlighted Click on the symbol again with the left mouse button and select FBettingsNunder the section Services so that the follow ing system configuration information is read out In addition the ACOM portofor the JMAnalyser BT to which the device is connected has to be selected within the device settings This one can be found as described under rPC settings with JMAnalyser BT in the system configuration Confirm by clicking FOKA The operational readiness of the device is confirmed through the flashing blue bluetooth LED FUJITSU PC 4 7 Taking the measurement system ou
27. for the JMAnalyser system For maintaining the correct state of the electrical equipment checks and technical safety inspections have to be carried out repeatedly e g within Germany acc to BGV A3 and accident prevention regulations and technical safety tests according to the Medical Device Operating Regulations Here it should be noted that standard regulations for electrical devices are concerned here and not measures that are specific to zebris For safety reasons it is recommended before each use of the measuring system to check the correct state of all the connection leads as well as the mains cable mains plug and mains socket Should certain parts be damaged these must be re placed before continuing to use the measuring system Immediate maintenance measures are to be carried out if a Fluid enters the device b Cable or cable connections have been damaged c Parts of the sensors were damaged d Covers have been damaged e A malfunction or a fault is suspected or has been detected lf the type plate or other important labels warning notices are damaged or oblite rated they have to be replaced by the manufacturer for safety reasons zebris Medical GmbH JMAnalyser Technische Daten und Gebrauchsanweisung Seite 26 38 5 2 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 s
28. hose in residential areas and those directly eo u connected to a public utility network also supplying buildings used for acc to IEC 61000 3 2 Emission of voltage fluctuations in compliance flickers acc to IEC61000 3 3 Guidelines and Manufacturer s Statement Electromagnetic Interference Immunity The JMAnalyser jaw motion measuring system is intended for use in the electromagnetic environment described below The customer or user of the JMAnalyser jaw motion measuring system should ensure that it is operated in such an environment Interference immunity IEC 60601 test levels Compliance level Electromagnetic environment guidelines tests Electrostatic discharge 6 kV contact discharge 6 kV contact discharge Flooring should be of wood or concrete or ESD acc to IEC 61000 4 2 Fast transient electrical interfer ences bursts acc to IEC 61000 4 4 Surges acc to IEC 61000 4 5 Blackouts brownouts and fluctuations of the power supply acc to IEC 61000 4 11 Magnetic field with supply frequency 50 60 Hz acc to IEC 61000 4 8 8 kV atmospheric discharge 2 kV for power lines 1 kV for input and output lines 1 kV differential mode voltage 2 kV common mode voltage lt 5 Ur gt 95 crash of the Ur for L period 40 Ur 60 crash of the Ur for 5 periods 70 Ur 30 crash of the Ur for 25 periods lt 5 Ur gt 95 crash of the Ur for5s laid with ceramic tiles If the floori
29. ing e g Nimeout reading from USBA v Precise and detailed description of the procedure that has led to the error message e g Measurement fIype A started then clicked on button B afterwards carried out movement fCQ switched to function PDQ when switching back the error message xyz occurred etc zebris Medical GmbH JMAnalyser Technische Daten und Gebrauchsanweisung Seite 28 38 5 4 Preparation Methods After every case of use of the JMAnalyser system a re preparation is required according to DIN EN ISO 17664 All accessory parts that come into contact with the patient s mucosa have to be sterilized be fore use Before starting cleaning work or disinfection switch the measurement system off under all circumstances and disconnect it completely from the power supply network WARNING The following accessory parts are only intended for one off use on a patient and should not be prepared again after use e Occlusale attachment REF 196 0270 e Bitefork type SD REF 196 0320 e EMG double electrode REF 810 0020 5 4 1 Manual cleaning e Before sterilization clean the accessory parts by hand under running water drink ing water quality 30 C 5 C flow rate 2 liters min with a medium strength tooth brush for 30 seconds e Complete the sterilization immediately subsequent to the cleaning e The cleaning of measurement systems and electrical accessories head bow lower jaw sensor foot pedal IR remote control should
30. isted in these operating instructions are used with the system zebris Medical GmbH JMAnalyser Technische Daten und Gebrauchsanweisung Seite 9 38 2 2 4 General safety Information D e 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 manufac turer 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 e Patients and measurement data may only be copied moved or deleted with the help of the database function that is provided by the zebris softwar application In the case of the deliberate changing of data without the database function the user alone bears the full risk e Measurement and analysis results should always be interpreted in the light of the clini cal history of the patient and in the context of other diagnostic tests by a trained per son proven and tested for their relevance e Should any measures for treatment be taken on the basis of the measuring results the measuring system may only be implemented as a supplementary means for evaluation by an expert On no account can or may invasive measures or measures endanger ing the patient be carried out solely on the basis of the measuring results without fur ther verification of the measuring data by additional methods e In the case of malfunctions and or
31. ld not be used on open wounds in the oral and head area where it may be used in patients of any age who are able to mentally follow the operator instructions exactly 2 1 1 Use zebris JMAnalyser systems are electronic registration systems that are based on 3D ultra sound measurements zebris JMAnalyser systems capture the individual mandibular movements of patients in all degrees of freedom which are necessary for the production of functional dentures and splints The 3D representation of the positions and movement traces occlusal or joint near meas urement points are particularly important information on the movement behavior of the temporomandibular joint and the lower or upper jaw teeth The 3D representation of prom inent positions in the face is a classification of the symmetry of the face to prepare the denture In a preliminary functional assessment discoordinations and movement limitations can be analyzed and documented The system is able to determine a neuromuscular jaw relation in the situation The electronic position analysis of the condyles allows the comparison of different occlusal positions and can thus give indications of possible pain vectors in the joint By means of a separate software module an analysis of chewing movements can be real ized The system determines the adjustment of fully adjustable virtual or mechanical articulators In conjunction with the zebris DAB Bluetooth the JMAnalyser product family enabl
32. measure ment system v to ensure that the device is functionally safe and in a proper stat prior to every in stance of use of the device v to protect oneself the patients and third parties against dangers v to prevent a contamination occurring due to the product e During use it is necessary to comply with the legal regulations especially v The current work safety regulations v The current accident prevention measures e Responsibility is assumed to ensure the safety reliability and effective performance of all measurement systems and accessories delivered by zebris such that v assembly work extensions new setting changes or repairs are carried out by zebris authorized trained technicians or by personnel of authorized dealers The storage and transport should only be carried out in the original packaging as pro vided by the manufacturer v the product operated in compliance with the operating instructions v the information technology components provided by the operator comply with the technical requirements for hardware and software contained in these operating in structions and that they are installed and set up according to the applicable de scriptions for these components v the place of installation corresponds with the specified environmental conditions for the measurement system and the current installation regulations v Only the software made available by zebris as well as the components and acceso ry parts l
33. nded for use with the device can lead to a re WARNING duced resistance to EMC interference of the JMAnalyser system The JMAnalyser measuring system should not be operated in the vicinity of e g X ray equipment motors or transformers with a high connected load as electrical or magnetic interference fields can in AN fluence the measurements The same is applicable for neighbouring power lines and equipment without a CE mark Should operation WARNING next to possible sources of interferences be necessary it is mandato ry to check and verify the correct function of the system zebris Medical GmbH JMAnalyser Technische Daten und Gebrauchsanweisung Seite 34 38 Guidelines and Manufacturer s Statement Electromagnetic Emission The JMAnalyser jaw motion measuring system is intended for use in the electromagnetic environment described below The customer or user of the JMAnalyser jaw motion measuring system should ensure that it is operated in such an environment Emitted interference measure Compliance Electromagnetic environment guidelines ments RF emissions The JMAnalyser jaw motion measuring system uses RF energy acc to CISPR 11 exclusively for its internal functions Therefore its RF emission is very low and it is unlikely that electronic equipment in close proximity will experience interference RF emissions class B The JMAnalyser jaw motion measuring system is intended for use in acc to CISPR 11 all facilities including t
34. ng is made of synthetic material the relative humidity must be at least 30 8 kV atmospheric discharge 2 kV for power lines 1 kV for input and output lines The quality of the supply voltage should be the same as the voltage of a typical busi ness or hospital environment 1 kV differential mode voltage 2 kV common mode voltage The quality of the supply voltage should be the same as the voltage of a typical busi ness or hospital environment lt 5 Ur gt 95 crash of the Ur for L period 40 Ur 60 crash of the Ur for 5 periods 70 Ur 30 crash of the Ur for 25 periods lt 5 Ur gt 95 crash of the U7 for5s The quality of the supply voltage should be the same as the voltage of a typical busi ness or hospital environment If the user of the JMAnalyser jaw motion measuring system requires the continuation of func tionality also after power interrup tions disruptions it is recommended to provide the JMAnalyser jaw motion measur ing system with power from an uninterrupti ble power supply Not tested as no influence Magnetic fields of the mains power fre is possible on the device quency should comply with the typical within the specified test values of a business and hospital environ level see Note B ment Uris the AC main voltage prior to applying the test levels zebris Medical GmbH JMAnalyser Technische Daten und Gebrauchsanweisung Seite 35 38 Gui
35. nweisung Seite 17 38 3 3 Accessories and spare parts REF No Description Illustrations 116 0010 JMAnalyser basic unit for direct connection with USB interface 116 0015 JMAnalyser BT basic unit for battery operation with Bluetooth interface 126 0010 Head bow type 14R for measurement systems JMAnalyser and JMA nalyser BT With all application parts 196 0130 Nasion support fitting for all zebris head bows 196 0140 Bearing seat fitting for all zebris head bows 196 0012 Bearing cushion green for bearing seat 196 0140 packaging unit 5 pieces 196 0013 Nose cushion green packaging unit 5 pieces 196 0014 Elastic neckband green packaging unit 5 pieces 1860420 USB adapter for JMAnalyer For connection to the PC zebris Medical GmbH JMAnalyser Technische Daten und Gebrauchsanweisung Seite 18 38 REF No 196 0112 196 0092 146 0010 191 0025 196 0260 196 0271 196 0270 196 0320 196 0400 126 0031 zebris Medical GmbH Description Headband green Lanyard green Lower jaw Sensor type 14T for measuring systems JMAnalyser and JMAna lyser BT pointer 80 medical steel sterilize able length 80mm ball aperture 1 5 mm Para occlusal attachment 90 for the fixation on the front teeth L 60 mm W 90 mn medical steel sterilize able occlusal adapter for the fixation of the lower jaw sensor at the occlusal attachment medical steel sterilize able length 60mm occlusal attachment made
36. rer reserves the right to carry out improvements to this manual and the product described therein at any time and without any further obligation Registered trade marks several brand names are referred within this User Manual All these product names are used only for clarity amp sake or for editorial reasons and are trademarks belonging to the respective companies When using the brand names the trade marks them and also the rights of the respective proprietors remain protected The name zebris is a registered trade mark and JMAnalyser identifies a product of the company zebris Medical GmbH Copyright This document and extracts taken from it may on no account be duplicated without the explicit consent of zebris Medical GmbH The content of this document may on no account be used for purposes that have not undergone approval by zebris Medical GmbH Any in fringement of the copyright is a punishable offence Copyright zebris Medical GmbH All rights reserved zebris Medical GmbH JMAnalyser Technische Daten und Gebrauchsanweisung Seite 3 38 1 2 Manufacturer and sales zebris Medical GmbH Max Eyth Weg 43 Phone 49 0 7562 9726 0 88316 Isny im Allgau Telefax 49 0 7562 9726 50 Deutschland E Mail support zebris de Web www zebris de 1 3 Layout of the user manual for the FDM System The user manual of the JMAnalyser Jaw Motion System consists of several parts 1 JMAnalyser system technical specifications and user manual 2
37. s listed above which have been manufactured by zebris at or after the date of issue The validity of this declaration expires with the release of a new dec laration due to technical or legal amendments however latest at the expiry date of the CE certificate ac cording to directive 93 42 EEC with certificate number CE 573437 D 88316 Isny 13 012 2013 Benannte Stelle Notified Body BSI Group Deutschland GmbH D 60314 Frankfurt am Main Wolfgang Brunner Gesch ftsf hrer Managing Director zebris Medical GmbH File N 03_Produkte_Hardwareizebris_Dental 0_Zulassung 10_ Konformit tserkl rung Declaration_Conformity_zebris_Dental_Annex_W_131213 dock Page 1 1 zebris Medical GmbH JMAnalyser Technische Daten und Gebrauchsanweisung Seite 37 38 7 Note zebris Medical GmbH JMAnalyser Technische Daten und Gebrauchsanweisung Seite 38 38
38. se note that no danger through summation of leakage currents can oc cur Devices that are in direct contact with the patient and that are com AN monly used in a medical electrical system as a whole have to fulfil WARNING all requirements of DIN EN 60601 1 2006 section 11 There is a danger of electric shock when touching devices that are not grounded separately zebris Medical GmbH JMAnalyser Technische Daten und Gebrauchsanweisung Seite 32 38 6 2 2 Vicinity of the patient test person For the definition of the patient amp surroundings experience shows that a value of 1 5 m distance to the patient is optimal r 1 5m When operating the system the user 2 must ensure that he does not touch the PC 3 and the patient 1 at the same time The same applies for all other non medical electrical components they may only be used outside the patient s vicinity Furthermore the user must ensure never to touch the contacts of the connectors of the interface box and the patient at the same time WARNING In case of non observance dangerous leakage currents can occur The following components of the JMAnalyser system may be used in the vicinity of the patient e JMAnalyser including sensor technology e zebris Measuring Systems for medical purposes e g CMS20 DAB Bluetooth The computer and other non medical electrical equipment e g camera equipment lights have to be located beyond the reach of the p
39. sult 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 zebris Medical GmbH JMAnalyser Technische Daten und Gebrauchsanweisung Seite 10 38 2 2 5 Safety information on heart pacemakers defibrillators e n the magnetic coupling for the attachment of the lower jaw 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 lt 15 cm these magnets can have a negative impact on the functionality of certain implanted heart pacemakers and defibrillators Therefore the lower Jaw sen sor should not be positioned on the upper body of the patient on patients with electron ic implants e 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 defibrilla tors by Bluetooth transmitters the JMAanalyser 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 patients thorax e No interference of electronic implants is to be expected from the ultrasonic transmitters used in the measurement system as the JMAnalyser system works with airborne sound and very low sound power of a
40. t 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 Next unplug the charger from the socket zebris Medical GmbH JMAnalyser Technische Daten und Gebrauchsanweisung Seite 25 38 5 Control measures Preparation Disposal 9 1 Mandatory periodic inspections and STK Scheduled maintenance of the system is essential in order to prevent IN damage and guarantees the safety of the device All methods concerning the sys temG maintenance and disinfection mentioned in this user manual should be car ried out on a regular basis Should any malfunctions and or defects be determined or suspected the device must be put out of operation immediately marked as Out Of Service and prevent ed from being used by removing the mains cable In such case be sure to contact the manufacturer or an authorized sales partner The maintenance of the device or its accessories going beyond the procedures de scribed in this user manual must exclusively be carried out by zebris Medical GmbH or a person who has been explicitly authorized by zebris to do this Be sure to switch of the measuring system and disconnect it from mains supply be fore starting any maintenance work The zebris Medical GmbH does not stipulate any safety related control A
41. tched on and being supplied with electricity green operating display LED is lit on the measurement system batteries are charged or charger and or USB cable is connected v Has the USB connection and or Bluetooth connection between the measurement system and measuring PC been made correctly v Are all the other components in the measurements system head bow lower jaw sensor foot pedal connected correctly Please find further information on error messages and troubleshoot ws ing in the user manual of the zebris DENTAL software NOTE Checklist for the reception of error messages f In order to support you the best way possible in case of malfunction e of your JMAnalyser measuring system our service employees need NOTE the following information v Serial number of the JMAnalyser System and the lower jaw sensor head bow The serial numbers are on the name plates on the rear of the measurement system and or on the cables for the head bow and lower jaw sensor v zebris DENTAL software version V Operating system version of your measurement PC e g Windows 7 Professional Service pack 1 to find under Windows 7 Windows Start button gt Control Panel gt System v Further components connected to the measurement system zebris DAB Bluetooth Video Kamera v List of all USB Bluetooth devices connected to the measurement system e g mouse printer other measuring systems etc v Screen shot of the error message or exact word
42. 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 Storage and transport of the measuring system are only to be effected in the original packaging provided by zebris Storage temperature 20 C to 70 C Relative humidity 5 to 90 Air pressure 700 hPa to 1060 hPa zebris Medical GmbH JMAnalyser Technische Daten und Gebrauchsanweisung Seite 8 38 2 2 3 Obligations of the user 1 e 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 zebris product appropriate tot he stated pur pose 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 e tis the obligation of the user v to comply with all the safety instructions stated in the operating instructions v to carry out all of the inspection and maintenance work regularly as specified in the operating instructions v to only use fault free working equipment v to ensure all the provided operating instructions that from part of the measurement system are accessible to all users at all time and to keep them near the
43. ty that das Medizinprodukt the medical device zebris Dental Kiefer Bewegungsanalysesystem zebris Dental Jaw Motionanalyser System Modell Typ Model Type JMAnalyser JMAnalyser BT JMT JMT BT UMDNS Nummer UMDNS Code 15 845 Klassifizierung classification Im nach Regel according to rule 12 den Anforderungen der unten genannten Richtlinien Normen soweit anwendbar entspricht meets allthe provisions of directives and standards listed below which apply to it Konformit tsbewertungsverfahren nach Richtlinie 93 42 EWG Anhang V ge ndert durch Richtlinie 2007 47 EWG conformity assessment procedure acc Directive 93 42 EEC Annex V amended by Directive 2007 47 EEC Angewandte harmonisierteNormen DIN EN 1041 DIN EN 60601 1 Applied harmonised standards DIN EN 1640 DIN EN 60601 1 2 DIN EN 7405 DIN EN 60601 2 40 DIN EN 13485 DIN EN 62304 DIN EN 14971 DIN EN 62366 DIN EN 15223 1 Diese Konformit tserkl rung gilt f r alle oben gelisteten Medizinprodukte welche am oder nach dem Aus gabedatum von zebris hergestellt worden sind Die G ltigkeit dieser Konformit tserkl rung endet mit der Ver ffentlichung einer Konformit tserkl rung neueren Datums falls dies durch technische nderungen am Produkt oder durch nderungen von Richtlinien oder Normen erfolgen muss sp testens jedoch mit Ablauf des CE Zertifikats nach Richtlinie 93 42 EWG mit Nr CE 573437 This declaration of conformity is valid for all medical device
44. uch as if the head bow or LJ sensor ZN should fall on the floor it is necessary to check the measurement func tion immediately In the event of evident damage to system compo nents warping dents cracks no further measurements should be carried out WARNING e The ultrasonic transmitters of the lower jaw sensor can be inspected for this function during a measurement by listening to see whether a regular cracking is emitted from each of the transmitters e To inspect the system for known jaw function measurements e g known maximum opening width known condylar range of motion with protrusion known horizontal condylar guidance inclination the user can measure himself with the measurement system These measurement results should correspond with the known values e When the sensors do not move the zebris DENTAL software should show an un moving image of the lower jaw Possible deviations spikes or jumps in the meas urement curve in spite of unmoved markers incorrect presentation of the lower jaw etc indicate a faulty measurement and impair the evaluation e Should doubts surround the measurement accuracy inspecting the JMAnalyser system at zebris is recommended in order o ensure the stated measurement accu racy zebris Medical GmbH JMAnalyser Technische Daten und Gebrauchsanweisung Seite 27 38 9 3 Troubleshooting Please check the following points if technical malfunctions should occur v Is the JMAnalyser system swi
45. uetooth O gt O gt zebris Medical GmbH JMAnalyser Technische Daten und Gebrauchsanweisung Seite 15 38 3 6 Assignment of the connecting sockets Foot pedal digital input black Signal GND BSL_START 3 3 Volt n C START_in DC Dig Input Signal Marker 1 Marker 2 Marker 3 Marker 4 SSW Bus n C SDA 12C SCL 12C 3 3 Volt Dig Input GND GND Head bow digital input white Signal Microphone 1 Microphone 2 Microphone 3 Microphone 4 SSW Bus Mik Select SDA I C SCL 12C 3 6 12Volt DRY_A DRY_G Dig Input GND GND Signal Power Signal GND n c zebris Medical GmbH JMAnalyser Technische Daten und Gebrauchsanweisung Pin Pin 1 Pin 2 Pin 3 Pin 4 Pin 5 Pin 6 Pin 7 Pin Pin 1 Pin 2 Pin 3 Pin 4 Pin 5 Pin 6 Pin 7 Pin 8 Pin 9 Pin 10 Pin 11 Pin 12 Pin 13 Pin 14 Pin Pin 1 Pin 2 Pin 3 Pin 4 Pin 5 Pin 6 Pin 7 Pin 8 Pin 9 Pin 10 Pin 11 Pin 12 Pin 13 Pin 14 Pin Pin 1 Pin 2 Pin 3 Pin 4 3 1 Digital inputs The measuring system JMAnalyser is equipped in standard specification with an against reverse polarity protected digital input It allows digital events such as are transmitted to the application programs from the footswitch To activate the inputs they are connected to the ground provided on each terminal Input resistance 10 KQ pull up Vum High Level Input Voltage gt 2 0V Vit Low Level Input Voltage lt 0
46. you will contribute to the effective use of natural resources Accumulators and batteries Accumulators and batteries must not be disposed of with domestic waste In the interest of environmental protection the consumer is legally obliged battery regulation to return old and used batteries Used accumulators and batteries can be disposed of at the collecting points of the community or where batteries of the relevant kind are sold For consumers the batteries are taken back free of charge zebris Medical GmbH JMAnalyser Technische Daten und Gebrauchsanweisung Seite 31 38 6 Safety standards and system classification 6 1 Classification acc to Annex IX of Directive 93 42 EEC The system is then classified as medical product Class I with measuring function 6 2 Safety of medical electrical devices The device fulfils the requirements of the standard DIN EN 60601 1 2006 Classification according to DIN EN 60601 1 Type BF Safety class II Steady state conditions Unsuitable for use in an oxygen enriched atmosphere 6 2 1 Connecting the JMAnalyser system to other electrical devices Quod vide DIN EN 60601 1 2006 section 16 medical electrical systems devices if these conform to the provisions of DIN EN 60950 or DIN EN 60601 1 or zebris Medical GmbH has confirmed their compatibil WARNING ity f The JMAnalyser System may only be coupled with other electrical When coupling several devices to one measuring station plea
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