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Related Manuals for Air Techniques CamX Elara
Summary of Contents for Air Techniques CamX Elara
- Page 1 CamX Elara / CamX Spectra EN-US Installation and Operating Instructions...
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Page 3: Table Of Contents
Technical data ....CamX Elara .... - Page 4 Contents 12.4 Automatic cleaning, intermediate rinsing, disinfection, final rinse, drying ..... 12.5 Steam sterilization ... . 12.6 Storage .
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Page 5: Important Information
These installation and operating instructions are – CAUTION an integral part of the unit. Risk of minor injuries Air Techniques shall not be held liable and – NOTICE offers no guarantees of the safe and Risk of extensive material/property damage... -
Page 6: Copyright Information
Air Techniques. CamX Elara The CamX Elara intraoral camera is inserted in or near to the oral cavity of the patient. The images support diagnosis, patient information and are used for instruction. -
Page 7: Fda Registration
Federal Acts. The device may be used CamX Elara only under permanent supervision by a dentist or The CamX Elara is inserted in or near to the oral licensed medical practitioner. cavity of the patient. The images support diagno-... -
Page 8: Combining Devices Safely
USB connection cable for As a result of their clinical training, they must CamX Elara/Spectra (8.2 ft) ... . J2020 ensure safe and appropriate handling. Each operator using the appliance must be ❯... -
Page 9: Notification Requirement Of Serious Incidents
State, in which the operator and/or patient is established/resident. Only use genuine parts Only use accessories and optional items speci- ❯ fied or approved by Air Techniques. Only use original working parts and spare ❯ parts. Air Techniques accepts no liability for... -
Page 10: Product Description
(possible variations due to country-spe- cific requirements and/or import regulations): CamX Elara ..... . . J2100 – Handpiece – Handpiece holder –... -
Page 11: Technical Data
Product description Technical data CamX Elara Electrical data Voltage V DC 4.75 - 5.25 Signal output USB 2.0 Type of protection IP20 Protection class Operating mode* T1/T2 = 27% 1.5 min / 5.5 min (On/off time) At an ambient temperature of max. 104 °F and while observing the on/off time, the handpiece reaches a maximum surface temperature of 140 °F. -
Page 12: Camx Spectra
Product description Optical system Focus level Depth of field 5 - 40 Aperture angle 68° Dimensions and weights Length 7.48 Diameter 1.02 Weight including cable Weight not including cable Cable length CamX Spectra Electrical data Voltage V DC 4.75 - 5.25 Signal output USB 2.0 Type of protection... -
Page 13: Ambient Conditions
Product description Electromagnetic compatibility (EMC) Interference immunity tests Emitted HF disturbance variables in accordance with Conforms IEC 61000-4-3 Camera electronics Image sensor 1/4" Color Interline Transfer CCD Number of sensor pixels 470000 Effective pixels (PC) YUV 704 x 576 Brightness control Automatic White balance Permanently set... -
Page 14: Model Identification Plate
Product description Function Model identification plate CamX Elara and Spectra are intraoral cameras. The model identification plate is on the hand- The function of the camera is identified by the piece. symbol on the rear. Conformity assessment This device has been subjected to conformity... -
Page 15: Camx Elara
– Detecting plaque and calculus – Detecting caries at an early stage – Fissure caries that is difficult to detect – Precise localization of carious lesions on smooth surfaces Fig. 2: CamX Elara – Visually-supported check during excavation 2108100003L29 J2001 2301V013... -
Page 16: Handpiece Holder
Product description Analysis Healthy tooth enamel The images are analyzed by the imaging software Initial caries, early stages of enamel with the aid of a filter. caries All images recorded with the CamX Spectra are Enamel caries up to the enamel/ identified by a Spectra icon on the top right. -
Page 17: Installation
Installation Installation Only qualified specialists or persons trained by Air Techniques may install, connect, and commis- sion the unit. System requirements The system requirements of the software being used to operate the device must always be met during its operation. -
Page 18: Assembling The Handpiece
Installation Commissioning and first Installation start-up Assembling the handpiece holder NOTICE Short circuit due to build up of con- The handpiece holder can be attached using the densation adhesive or screws. Use suitable mounting materials. Do not put the appliance into operation ❯... -
Page 19: Using The Device In Dbswin Or Vistaeasy
In the tree directory, various settings can be Working under Control type, select the camera ❯ adjusted. They vary depending on the connected CamX Elara or CamX Spectra. device and can depend on the installed firmware version. Acquisition settings Camera trig-... - Page 20 Video source Start VistaConfig using Start > All Programs > ❯ WDM driver The WDM driver is selected Air Techniques > VistaEasy > VistaConfig. automatically. The camera is detected and activated auto- Noise reduc- If noise reduction is active, the matically.
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Page 21: Commissioning Tests
Installation Commissioning tests Electrical safety checks Carry out an electrical safety check according ❯ to all national regulations. Document the results. ❯ The handpiece is applied part in accord- ance with IEC 60601-1. Handover record Carry out and document the instruction and ❯... -
Page 22: Usage
Usage Lift the white edge of the hygienic protective ❯ Usage cover and slide the camera head into the cover. The transparent plastic side must face upwards. 10 Operation NOTICE Damage to the camera by dropping or scratching Always store the camera in the hand- ❯... -
Page 23: Taking An Image Using Camx
Usage 10.3 Taking an image using CamX 10.4 Taking an image using CamX Elara Spectra When imaging with the Spectra interchangeable Taking a picture head, two views are possible in the imaging soft- ware. CAUTION Prophylaxis view The blue-violet LED light This provides an informative overview of Do not peer into the light source. - Page 24 Usage Putting on the spacer Press on one of the capture buttons. ❯ WARNING Danger of cross-contamination when used without preparation or following incorrect preparation Sterilize the spacer in the steam steri- ❯ lizer (see "12 Reprocessing the spacer") before each use. Hold the camera with the properly applied ❯...
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Page 25: Switching Off The Camera
Usage 10.5 Switching off the camera WARNING Danger from the re-use of products intended for single use Single-use article is damaged after use and cannot be reused. Dispose of single-use articles after use. ❯ Carefully pull off the hygienic protective cover ❯... -
Page 26: Reprocessing Of The Device
The reprocessing procedure was validated as fol- lows: – Pre-cleaning – Lint-free disposable wipe – Manual cleaning – Monarch disinfection wipes (Air Techniques) – Manual disinfection – Monarch disinfection wipes (Air Techniques) EN-US 2108100003L29 J2001 2301V013... -
Page 27: General Information
Usage 11.3 General information Protect the unit from contamination when ❯ transporting it from the treatment chair to the Comply with all national directives, standards ❯ reprocessing location. and specifications for the cleaning, disinfection and sterilization of medical devices as well as 11.5 Manual cleaning, disinfection the specific specifications for dental practices... -
Page 28: 12 Reprocessing The Spacer
Usage 12 Reprocessing the spacer Repeat this step with a new disinfection wipe ❯ for 2 minutes. This means that the entire disinfection step is 12.1 Risk analysis and classifica- performed for 3 minutes. tion Drying A risk analysis and classification of medical devi- Allow the device to air-dry. -
Page 29: Preparation At The Operating
Usage General information Important information! Comply with all national directives, standards ❯ The reprocessing instructions in accord- and specifications for the cleaning, disinfection ance with FDA Guidance "Reprocessing and sterilization of medical devices as well as Medical Devices in Health Care Settings - the specific specifications for dental practices Validation Methods and Labeling"... -
Page 30: Automatic Cleaning, Intermediate Rinsing, Disinfection, Final Rinse, Drying
Usage Clean the spacer with a disposable wipe 12.5 Steam sterilization ❯ soaked in cold tap water until no more dirt or contamination can be seen. WARNING Protect the unit from contamination when ❯ Health risk due to improper steriliza- transporting it from the treatment chair to the tion reprocessing location. -
Page 31: 13 Cleaning
Usage 13 Cleaning 14 Maintenance The unit is maintenance-free. 13.1 Cleaning the camera lens NOTICE Damage to the optical element from incorrect cleaning Disinfectant residues soil the optical ele- ment. Only use the enclosed microfiber cloth ❯ and alcohol. Clean the window of the optical window using ❯... -
Page 32: Troubleshooting
Troubleshooting Troubleshooting 15 Tips for operators and service technicians Any repairs above and beyond routine maintenance may only be done by suitably qualified per- sonnel or by one of our service technicians. Error Possible cause Remedy Image contains a high amount Penetration of external light Check the position of the ❯... -
Page 33: Appendix
Appendix Appendix 16 Handover record This document confirms that a qualified handover of the medical device has taken place and that appropriate instructions have been provided for it. This must be carried out by a qualified adviser for the medical device, who will instruct you in the proper handling and operation of the medical device. Product name Order number (REF) Serial number (SN) - Page 38 Manufactured for / Distributed by: Air Techniques, Inc. 1295 Walt Whitman Road Melville, New York 11747-3062, USA Phone: 800-247-8324 Fax: 888-247-8481 www.airtechniques.com Hersteller / Manufacturer: DÜRR DENTAL SE Höpfigheimer Str. 17 74321 Bietigheim-Bissingen Germany www.duerrdental.com...
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