zebris ARCUSdigma 3 User Manual
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zebris ARCUSdigma 3 User Manual

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ARCUSdigma 3
User Manual
Textrelease R 2

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Summary of Contents for zebris ARCUSdigma 3

  • Page 1 ARCUSdigma 3 User Manual Textrelease R 2...
  • Page 2 Hardware User Manual ARCUSdigma 3 System © 2021 zebris Medical GmbH All rights reserved. Reproduction in whole or in part only with the permission of zebris Medical GmbH. Textrelease: R 2 Stand: 19.09.2021 REF: 79011405 Illustrations of this manual may differ.

  • Page 3: Table Of Contents

    3.2. Funktional principle of the ARCUSdigma 3 system 3.3. Elements of the ARCUSdigma 3 system 3.4. Face bow 3.4.1. Technical data 3.4.2. Type plate of the ARCUSdigma 3 face bow 3.4.3. State LEDs 3.5. Lower jaw sensor (UK-Sensor) 3.5.1. Technical data 3.5.2.
  • Page 4 3.7.3. Changing the battery 4 Accessories and spare parts 4.1. Hardware 4.2. Software 5 Putting the system into operation 5.1. Power supply and charging the batteries 5.2. Lower jaw sensor 5.3. IT security and software installation 6 Decommission the system 7 Funktional checks and disposal 7.1.

  • Page 5: User Information

    The part technical specifications and instructions for use of the ARCUSdigma 3 hardware primarily contains information on technical data and the operation of the ARCUSdigma 3 system as well as information on its safe operation in combination with the patient accessories such as bite fork or jaw attachment.

  • Page 6: Symbols Used On Products, Packaging And User Manual

    1.3 Symbols used on products, packaging and instructions for use Warning instructions designate a potential danger to the health and safety of users and/or patients. The instructions explain the type of danger and how it can be avoided. Notices designate a potential danger that can cause damage to the device. The instructions explain the type of danger and how it can be avoided.

  • Page 7: Area Of Use And Safety

    The system software calculation of adjustment data of fully adjustable articulators. It supports several well established articulators. Interfaces for data export enable the use of the movement data recorded by the ARCUSdigma 3 in CAD/CAM systems and CBCT systems for the functional optimization of dental prostheses and bite splints.

  • Page 8: Safety

    2.2. Safety 2.2.1. Environmental conditions The ARCUSdigma 3 is suitable for use in dry interior rooms, as can be found in clinics, medical practices and laboratories. Temperature: 0°C to 45°C (32°F to 113°F) Air pressure: 700 - 1100 hPa Relative humidity: max.

  • Page 9: Obligations Of User

    • The current work safety regulations. • The current accident prevention measures. Responsibility for safety, reliability and effective performance of the ARCUSdigma 3 is assumed in case: • Assembly work, extensions, new setting, changes or repairs are carried out by trained technicians or dealers explicitly authorized by the manufacturer.

  • Page 10: General Safety Information

    • Patients and measurement data may only be copied, moved or deleted with the help of the database function that is provided by the zebris software application. In the case of the deliberate changing of data without the database function, the user alone bears the full risk.

  • Page 11: Safety Information On Heart Pacemakers/Defibrillators

    • The ARCUSdigma 3 can be operated wireless via WiFi as an interface to the evaluation PC. Although there are no indications of possible interference with electronic implants by WiFi transmitters, it is recommended for patients with electronic implants to keep the face bow of the ARCUSdigma 3 at least 15 cm away from the patient’s thorax.

  • Page 12: Produkt Description

    • Accessories (IR foot switch, T pointer, C bow, bite fork, lower jaw attachments) 3.2. Functional principle of ARCUSdigma 3 System The ARCUSdigma 3 system is a 3D coordinate measuring system. It consists of a facebow (receiver and control unit), the mandibular sensor (transmitter unit) and an optional charging station.

  • Page 13: Elements Of The Arcusdigma 3 System

    3.3. Elements of the ARCUSdigma 3 System IR-Sync LED’s Product label Camera modules left / right Connection socket: external power supply / data transmission Cable guide / strain relief Knurled screw for locking: overhead band Knurled screw for locking: bearing seat...

  • Page 14: Face Bow

    3.4 ARCUSdigma 3 Face Bow Cleanliness / integrity of the optical components (1 & 3) must be checked before each use to ensure the accuracy of the measuring system. The transport switch (11) disables the batteries to prevent accidental activation of the head bow and discharge of the batteries.

  • Page 15: Technical Data

    Therefore it is required to sent the 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. 3.4.2 Type plate ARCUSdigma 3 Face Bow Seite 15/43 15/41...

  • Page 16: Stateleds

    3.4.3. StateLEDs LED Signal State/Meaning WIFI/(A) Flashing, blue WiFi not connected / active Permanent on, blue 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 &...

  • Page 17: Lower Jaw Sensor (Uk-Sensor)

    3.5. UK-Sensor OJM-UK1 (Lower Jaw Sensor) IR-Sync LED’s, Lower jaw sensor Magnetic coupling for lower jaw attachment Product labeling: Label, Lower jaw sensor Status-LED, Lower jaw sensor, “Measurement active” (green) Cleanliness / integrity of the optical components (12) must be checked before each use to ensure the accuracy of the measuring system.

  • Page 18: Changing The Battery

    3.5.3. Changing the battery To replace the battery of the lower jaw 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 CR1632) into the battery holder and screw the cover back on.

  • Page 19: Induktive Charger

    3.6. Induktive charger ARCUSdigma 3 The inductive charger is used for wireless charging of the ARCUSdigma 3 head bow and for storing the head bow and the UK sensor. The charging process starts automatically when the head bow is inserted into the charger and the USB socket (15) is connected to a power source.

  • Page 20: Ir Foot Switch

    3.7. IR foot switch The foot switch provides wireless control of the ARCUSdigma 3 software. Each activation of the foot switch triggers the “next” function in the ARCUSdigma 3 software 1x and initiates the next step in the work flow.

  • Page 21: Changing The Battery

    3.7.3. Changing the battery To replace the battery of the IR 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 battery (type 6LR91) into the battery holder and screw the cover back on.

  • Page 22: Accessories And Spare Parts

    1.014.6245 black, pack of 10 Nose Cushion 1.014.6246 black, pack of 10 Overhead Band, 1.014.6247 for ARCUSdigma 3 face bow UK-Sensor OJM-UK1 1.014.6225 Lower jaw sensor with magnetic holder 1.000.9291 Para-Occlusal Attachment for attachment to the anterior teeth Upper Jaw Bite Fork AD 3 3.002.6032...
  • Page 23 Inductive Charger ARCUSdigma 3 Table stand with inductive charging station including charging cable USB Adapter 1.014.6228 connects the ARCUSdigma 3 face bow to the PC and charges the battery USB Cable 1.007.8212 Type A-B 0,90m, for connecting the USB power supply to the inductive charger Power Supply AD3 1.014.6231...

  • Page 24: Software

    The basic version includes licenses for installation on 3 PCs. Extension to install the software on one additional PC 1.014.6242 ARCUSdigma 3 Software Suite External Database Enables the installation of the zebris database in a freely configurable network path Seite 24/43 24/41...

  • Page 25: Putting The System Into Operation

    5 Putting the system into operation Commissioning the ARCUSdigma 3 system requires the USB adapter (REF 1.014.62287), the WiFi USB adapter (REF 1.014.6227) and the ARCUSdigma 3 software. All components are included with the ARCUSdigma 3 system. 5.1. Power supply and charging the batteries There are three ways to charge the batteries in the face bow.

  • Page 26: Lower Jaw Sensor

    If in question please contact a dealer authorized by the manufacturer. For the requirements of the ARCUSdigma 3 software with concern to a PC / laptop, please refer to the instructions for use on ARCUSdigma 3 software.

  • Page 27: Decommission The System

    6 Decommission the system To take the system out of service, first close the ARCUSdigma 3 software and then shut down the PC. Move the face bow transport switch to position (0) and store face bow in transport case.

  • Page 28: Funktional Checks And Disposal

    7 Functional checks, preparation, disposal Regular maintenance of the system helps to prevent damage and guarantees its long-term ● safety. All of the procedures described in these instructions for use concerning maintenance and preparation of the system are to be carried out on a regular basis. If the system or accessory parts show damage, they should be sent to the manufacturer for a ●...

  • Page 29: Checking The Measurement Function

    In the case of recognizable damage to system components (deforma- tion, dents, cracks), no further recordings may be made. If the surfaces of the IR filter discs on the ARCUSdigma 3 face bow and / or lower jaw sensor are scratched, use is prohibited. Correct results can not be guaranteed.

  • Page 30: Troubleshooting

    7.3. Troubleshooting In case of problems, please first check the following points: Is the ARCUSdigma 3 system switched on and powered? When the green status LED’s on face bow ● and lower jaw sensor are lit, the batteries are charged or an external power source is connected and the system is ready for use.

  • Page 31: Preparation

    7.4 Preparation After each use of the ARCUSdigma 3 system, reprocessing according to DIN EN ISO 17664 is necessary. Components that come into contact with the patient‘s mucous mem- branes (semicritical) must be cleaned, disinfected and sterilized before each use. This is also necessary for the first use after delivery of the non- sterile components.

  • Page 32: Manual Disinfection

    7.4.2 Manual disinfection The facebow and mandibular sensor can be disinfected by wiping with suitable solutions. The disinfection of the facebow and mandibular sensor is carried out in the switched-off state unplugged from the charger or USB cable, with a cloth moistened with disinfectant solution. Recommended disinfectant Composition approx.

  • Page 33: Mechanical Cleaning And Disinfection

    7.4.4 Mechanical cleaning and disinfection When selecting the washer-disinfector (WD), the following points must be observed: The cleaning and disinfection device must have a fundamentally tested effectiveness ● (e.g., CE marking in accordance with DIN EN ISO 15883). Basic suitability of the program for instruments as well as sufficient rinsing steps ●...

  • Page 34: Control

    Mechanical cleaning/disinfection (validated process) Phase Step T[˚C/˚F] t[min] Waterquality Comment Pre-rinse < 40/104(cold) Emptying Cleaning 55/131 neodisher® MediClean Dental Emptying Rinse < 40/104 Emptying Rinse < 30/86(cold) VE-W Emptying Thermo- 90/194 VE-W disinfection Emptying Drying > 90/104 T-W: Drinking water VE-W: Fully demineralized water (demineralized, microbiologically at least drinking water quality) Validated with: neodisher®...

  • Page 35: Packing

    7.4.6 Packaging Place the cleaned and disinfected components in sterile single-use packaging that comply with the following requirements: EN/ISO/ANSI AAMI ISO 11607 (for the USA: FDA approval). ● Suitable for steam sterilization (temperature resistance to at least 142°C, ● Sufficiently penetrable by steam). Sufficient protection of the components as well as the sterile packaging against ●...

  • Page 36: Summary Table

    Mechanical Sterilization Multiple use Classification accor- Cleaning/ Cleaning/ ding to RKI/BfArM/ Disinfection Disinfection Kriniko guideline (validated) 1.014.6209 ARCUSdigma 3 not permissible Immersion permissible not permissible non-critical permissible Face Bow not permissible Wipe disinfection 1.014.6234 Retainer for Face Bow not permissible...

  • Page 37: Disposal

    Disposal 7.5.1. Packaging All transport packaging’s delivered by zebris Medical GmbH 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.

  • Page 38: Safety Standards And System Classification

    8.2.1. Connecting the system to other electircal devices (also refer to DIN EN 60601-1:2013 section 16 medical electrical systems) The ARCUSdigma 3 system may only be coupled with other electrical devices if these conform to the provisions of DIN EN 60950 or DIN EN 60601-1 or the manufacturer has confirmed their compatibility.

  • Page 39: Multiple Sockets

    Failure to comply can lead to the occurrence of dangerous leakage currents. The following components of the ARCUSdigma 3 system may only be used within the patient environment: ARCUSdigma 3 system (face bow, lower jaw sensor, accessories) ●...

  • Page 40: Electromagnetic Compatibility Guideline

    Guidelines and manufacturer‘s declaration - Electromagnetic emissions The ARCUSdigma 3 system is intended for operation in the electromagnetic environment specified below. The customer or the user of the ARCUSdigma 3 system should ensure that it is operated in such an environment.
  • Page 41 Guidelines and manufacturer‘s declaration - Electromagnetic immunity The ARCUSdigma 3 is intended for operation in the electromagnetic environment specified below. The customer or the user of the ARCUSdigma 3 system should ensure that it is used in such an environment.
  • Page 42 Guidelines and manufacturer‘s declaration - Electromagnetic immunity The ARCUSdigma 3 system is intended for operation in the electromagnetic environment specified below. The customer or the user of the ARCUSdigma 3 system should ensure that it is used in such an environment.
  • Page 43 Recommended protective distances between portable and mobile RF communications equipment and the ARCUSdigma 3 system The ARCUSdigma 3 system is intended for operation in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ARCUSdigma 3 system can help prevent electromagnetic interference by maintaining the minimum separation between portable and mobile RF communication devices (transmitters) and the ARCUSdigma 3 system, depending on the output power of the communication device.

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