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User Manual and technical data

JMA

Optic

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Содержание JMAOptic

Страница 1: ...User Manual and technical data JMAOptic...

Страница 2: ...strations of this manual may differ Manufacturer zebris Medical GmbH Phone 49 0 7562 9726 300 Am Galgenbu hl 14 Fax 49 0 7562 9726 50 D 88316 Isny im Allg u Email sales zebris de Germany web www zebri...

Страница 3: ...2 5 Safety information on heart pacemakers defibrillators 2 2 6 Prohibited use 3 Produkt description 3 1 System components 3 2 Funktional principle of the JMA Optic system 3 3 Elements of the JMA Opt...

Страница 4: ...m 7 Funktional checks and disposal 7 1 Regular checks and safety checks 7 2 Kontrolling the measurement function 7 3 Troubleshooting 7 4 Checklist for the recording of error messages 7 5 Disposal 7 5...

Страница 5: ...lassificatio pursuant to appendix IX of the directive 93 42 EEC 9 2 Safety of medical electrical devices 9 2 1 Connecting the system to other electrical devices 9 2 2 Environment of the patient 9 2 3...

Страница 6: ...ctions for us of the application software WINJAW The part technical specifications and instructions for use of the JMA Optic hardware primarily contains information on technical data and the operation...

Страница 7: ...ns explain the type of danger and how it can be avoided CE mark according to EC directive 93 42 medical devices Manufacturer Date of manufacture Type BF device corresponding to DIN EN 60601 1 HF trans...

Страница 8: ...the lower jaw Subsequently a measurement can be performed Through the visualization of positions and movements disorders of the dental oral jaw system stomatognathic system can be determined Function...

Страница 9: ...ed load for example or heavy current power lines as electrical or magnetic interference fields can distort the correct measurements and or render them impossible Do not operate the device in the immed...

Страница 10: ...ies against dangers To prevent a contamination occurring by the product During use it is necessary to comply with the legal regulations especially The current work safety regulations The current accid...

Страница 11: ...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 a...

Страница 12: ...system 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 accuracy In the case of malfu...

Страница 13: ...ar sensor transmitter unit and an optional charging station The optional charging station is also used to store the system and is used for inductive charging of the batteries built into the facebow Th...

Страница 14: ...11 Transport switch 12 IR Sync LED s lower jaw sensor 13 Magnetic coupling lower jaw sensor 14 Product label lower jaw sensor 15 Power supply USB socket inductive charger 16 Product label inductive c...

Страница 15: ...vation of the head bow and discharge of the batteries Cleanliness integrity of the optical components 1 3 must be checked before each use to ensure the accuracy of the measuring system Seite 15 69 Pag...

Страница 16: ...device to the manufacturer Never attempt to open the face bow or replace the batteries yourself as this may affect the measurement accuracy and may result in an electric shock Seite 16 69 Page 16 47...

Страница 17: ...e WiFi connected and active Recording B Flashing green Face bow is switched on and ready for operation Permanent on green Face bow is in operation Power Supply Battery Charging C Flashing slow orange...

Страница 18: ...Jaw Sensor 12 IR Sync LED s 13 Magnetic coupling for lower jaw attachment 14 Product label D Status LED Measurement active green 3 5 1 Technical data Property Value Dimensions W x H x L 67 x 15 x 45...

Страница 19: ...sensor proceed as follows Required Materials Screw driver Type TX 06 Coin Cell Type CR1632 Open the cover of the battery with a screwdriver TX06 Remove the used battery Insert the new battery type CR1...

Страница 20: ...socket Inductive charger 16 Product labeling Label Inductive charger E Status LED Inductive charger Power supply green 3 6 1 Technical data Property Value Dimensions W x H x L 101 x 105 x 127 mm Weigh...

Страница 21: ...permanently for more than approx 2 seconds the electronics automatically switches off and the status LED shuts of 17 Product labeling Label IR Foot switch F Status LED IR Foot switch Device active gre...

Страница 22: ...the foot switch proceed as follows Required Materials Screw driver type PH 0x40 Battery type 6LR91 9Volt Open the cover of the battery with a screwdriver PH 0x40 Remove the used battery Insert the new...

Страница 23: ...Hardware REF Description Figure 01170010 JMA Optic Face Bow 01470000 UK Sensor OJM UK1 Lower jaw sensor with magnetic holder 01960145 Replacement Battery Torx Screw for UK Sensor 01870010 Inductive Ch...

Страница 24: ...25 Pointer Pin 80 to be used with the C bow 01960160 Porus Buttons for C Bow Pack of 2 01960250 Para Occlusal Attachment with Lip Arch for attachment of the lower jaw sensor to the teeth 01960255 Para...

Страница 25: ...t to the anterior teeth 01960271 Occlusal Adapter for attachment of the lower jaw sensor to the occlusal attachment 01960320 Bite Fork Type SD for temporary fixation to the maxilla contains three thre...

Страница 26: ...fork adapter 1 set of position bolts 3 of each type 3x fixing nut 5x positioning foil and a quick guide 01960501 Positioning Screw Set Set consisting of 3 positioning screws in lengths of 30 mm 45 mm...

Страница 27: ...nt parameters for the Zirkonzahn PS1 3D articulator 07210205 WINJAW CMDfact Interactor Software module for diagnostic evaluation for CMDfact and CMDtrace 07210000 WINJAW Licence Enhancement The basic...

Страница 28: ...and arrange the measurement system such that the plug for the power socket is easily accessible at all times and the device can be easily disconnected from the mains Visually inspect the power supply...

Страница 29: ...shipped with a computer and properly installed WINJAW software the opera tor is responsible to ensure that the safety of patients operators and environment is not compro mised by the computer If in q...

Страница 30: ...fe operation of the measuring system are the aspects of data protection virus security updates of the operating system and regular backups of the WINJAW database on external data carriers of essential...

Страница 31: ...cturer or authorized organizations Prior beginning the preparation switch the measurement system off under all circumstances and disconnect it completely from the power supply 7 1 Regular checks and s...

Страница 32: ...t the latest after 3 years by the manufacturer Seite 32 69 Page 32 47 JMA Optic 7 2 Checking the measurement function To inspect the system for known jaw functioning measurements e g known maximum ope...

Страница 33: ...ges Serial numbers of face bow and the lower jaw sensor The serial numbers are on the type plates located on the bottom of face bow and lower jaw sensor WINJAW software version The version of the WINJ...

Страница 34: ...product cannot be disposed of via the household waste and must be disposed of separately within Europe For this purpose at the end of its product life the measurement system can be returned by the cus...

Страница 35: ...rts are delivered non sterile After each use of the JMA Optic system reprocessing according to DIN EN ISO 17664 is necessary Seite 35 69 Page 35 47 JMA Optic 8 Preparation 8 1 Manual pretreatment Work...

Страница 36: ...infectant manufacturers with regard to concentration temperature immersion time and rinsing must be observed Please use only freshly prepared solutions as well as exclusively sterile or low contaminat...

Страница 37: ...ities of the components at the beginning and at the end of the immersion time flush at least five times using a disposable syringe minimum volume 5 ml Check components see chapter 8 4 Inspection p 39...

Страница 38: ...xample purified or highly purified water Exclusive use of filtered air oil free low contamination with microorganisms and particles for drying Regular maintenance and inspection calibration of the WD...

Страница 39: ...touch any other instruments instrument parts no rinsing shadow Start a tested program with the following characteristics Sufficient cleaning effect Final rinse with distilled or fully demineralized wa...

Страница 40: ...sterilization Fractionated vacuum process Autoclave according to EN 13060 EN 285 or ANSI AAMI ST79 for the USA FDA approval Validated according to EN ISO 17665 valid IQ OQ commissioning and product s...

Страница 41: ...sible permissible not permissible non critical permissible 11502501 Bearing Cushion not permissible permissible permissible not permissible non critical permissible 11502503 Nose Cushion not permissib...

Страница 42: ...separately Seite 42 69 Page 42 47 JMA Optic 9 Safety standards and system classification 9 1 Classification pursuant to appendix IX of the directive 93 42 EEC The system is classified as a medical pr...

Страница 43: ...of the face bow always directly to a wall socket with a tested protective earth and separate fuse Seite 43 69 Page 43 47 JMA Optic The following components of the JMA Optic system may only be used wi...

Страница 44: ...ts of the EN 60601 1 2 standard 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 th...

Страница 45: ...V Common mode voltage 5 U T 95 dip of U T for period 40 U T 60 dip of the U T for 5 periods 70 U T 30 dip of the U T for 25 periods 5 U T 95 dip of U T for 5 s 3 A m IEC 60601 Test level 6 kV contact...

Страница 46: ...er or the user of the JMA Optic system should ensure that it is used in such an environment Guidelines and manufacturer s declaration Electromagnetic immunity a The field strength of stationary transm...

Страница 47: ...ransmitter W 0 01 0 1 1 10 100 150 kHz bis 80 MHz d 1 2 P 0 12 0 38 1 2 3 8 12 Protective distance depending on the transmitting frequency m 80 MHz bis 800 MHz d 1 2 P 0 12 0 38 1 2 3 8 12 800 MHz bis...

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