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ARCUSdigma 3

User Manual

Textrelease R 2

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Содержание ARCUSdigma 3

Страница 1: ...ARCUSdigma 3 User Manual Textrelease R 2...

Страница 2: ...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 zebris de Sales KaVo Dental GmbH Phone 49 0 7351 56 0 Bismarkring 39 Fax 49 0 7351 5...

Страница 3: ...rt pacemakers defibrillators 2 2 6 Prohibited use 3 Produkt description 3 1 System components 3 2 Funktional principle of the ARCUSdigma 3 system 3 3 Elements of the ARCUSdigma 3 system 3 4 Face bow 3...

Страница 4: ...isinfection 7 4 3 Manual cleaning 7 4 4 Mechanical cleaning and disinfection 7 4 5 Control 7 4 6 Packing 7 4 7 Sterilization 7 4 8 Summary table 7 5 Disposal 7 5 1 Packaging 7 5 2 Disposal of electron...

Страница 5: ...of the application ARCUSdigma 3 software The part technical specifications and instructions for use of the ARCUSdigma 3 hardware primarily contains information on technical data and the operation of...

Страница 6: ...anger that can cause damage to the device The instructions 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...

Страница 7: ...r 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 Functional analys...

Страница 8: ...d 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 immediate v...

Страница 9: ...t 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 accident preven...

Страница 10: ...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 Th...

Страница 11: ...n 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 malfunctions...

Страница 12: ...ular 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...

Страница 13: ...ansport 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 charger...

Страница 14: ...l activation 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 14...

Страница 15: ...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 15 43 15 41 3 4 1...

Страница 16: ...onnected 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 Warning...

Страница 17: ...r 13 Magnetic coupling for lower jaw attachment 14 Product labeling Label Lower jaw sensor D Status LED Lower jaw sensor Measurement active green 3 5 1 Technical data Property Value REF 01470000 Dimen...

Страница 18: ...roceed 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 CR1632 into...

Страница 19: ...ctive charger 16 Product labeling Label Inductive charger E Status LED Inductive charger Power supply green 3 6 1 Technical data Property Value REF 01870040 Dimensions W x H x L 101 x 105 x 127 mm Wei...

Страница 20: ...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 green Battery...

Страница 21: ...ot 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 batte...

Страница 22: ...scription Figure 1 014 6209 ARCUSdigma 3 Face Bow 1 014 6234 Retainer for Face Bow including knurled nut 1 014 6245 Bearing Cushion black pack of 10 1 014 6246 Nose Cushion black pack of 10 1 014 6247...

Страница 23: ...station including charging cable 1 014 6228 USB Adapter connects the ARCUSdigma 3 face bow to the PC and charges the battery 1 007 8212 USB Cable Type A B 0 90m for connecting the USB power supply to...

Страница 24: ...tware Suite Support of Third Party Articulators Software module for support of articulators of other manufacturers 1 014 6241 ARCUSdigma 3 Software Suite License Extension The basic version includes l...

Страница 25: ...sockets to combine medical and non medical devices There is the risk of an electrical shock upon contact with devices that are not earthed separately also refer to chapter 8 2 3 Multiple sockets S 41...

Страница 26: ...properly installed ARCUSdigma 3 software the operator is responsible to ensure that the safety of patients operators and environment is not compromised by the computer If in question please contact a...

Страница 27: ...nction with a hardware firewall in order to minimize risks due to the Internet connection Never use the local computer with Internet access with administrator rights The computer needs to be CE marked...

Страница 28: ...r 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 safety ch...

Страница 29: ...ated at the latest after 3 years by the manufacturer Seite 29 43 29 41 7 2 Checking the measurement function To inspect the system for known jaw functioning measurements e g known maximum opening widt...

Страница 30: ...umbers 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 l ARCUSdigma 3 software version The version of the ARCUSdig...

Страница 31: ...n ultrasonic bath should only be used if a mechanical workflow is not available In this case the significantly lower effectiveness and reproducibility of a manual process must be taken into account Af...

Страница 32: ...itched off state unplugged from the charger or USB cable with a cloth moistened with disinfectant solution Recommended disinfectant Composition approx 25 ethanol 35 propanol e g Mikrozid Wipes cleanin...

Страница 33: ...e purified or highly purified water l Exclusive use of filtered air oil free low contamination with microorganisms and particles for drying l Regular maintenance and inspection calibration of the WD C...

Страница 34: ...instruments instrument parts no rinsing shadow Start a tested program with the following characteristics l Sufficient cleaning effect l Final rinse with distilled or fully demineralized water l Therm...

Страница 35: ...0 F 273 F 5 minutes Seite 35 43 35 41 7 4 6 Packaging Place the cleaned and disinfected components in sterile single use packaging that comply with the following requirements l EN ISO ANSI AAMI ISO 11...

Страница 36: ...disinfection permissible not permissible non critical permissible 1 014 6477 C Bow permissible Immersion not permissible Wipe disinfection permissible Standard procedure non critical permissible Poru...

Страница 37: ...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 customer to...

Страница 38: ...unded separately Seite 38 43 38 41 8 Safety standards and system classification 8 1 Classification pursuant to appendix IX of the directive 93 42 EEC The system is classified as a medical product of C...

Страница 39: ...upply of the face bow always directly to a wall socket with a tested protective earth and separate fuse Seite 39 43 39 41 The following components of the ARCUSdigma 3 system may only be used within th...

Страница 40: ...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 the medi...

Страница 41: ...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 discharg...

Страница 42: ...ser of the ARCUSdigma 3 system should ensure that it is used in such an environment Guidelines and manufacturer s declaration Electromagnetic immunity a The field strength of stationary transmitters s...

Страница 43: ...ansmitter 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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