Acteon SOPIX Series User Manual
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Acteon SOPIX Series User Manual

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SOPIX SERIES
User's manual

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Summary of Contents for Acteon SOPIX Series

  • Page 1 SOPIX SERIES User’s manual...

  • Page 2: Table Of Contents

    DIGITAL X-RAY SYSTEM INTRODUCTION ..............3 PRECAUTIONS FOR USE ..................5 STANDARDS AND REGULATIONS ................8 SYSTEM CONFIGURATION .................. 14 INSTALLATION AND CONNECTION ................ 16 USE ......................18 MAINTENANCE ....................20 AFTER-SALES SERVICE ..................23 TECHNICAL FEATURES ..................25 SOPIX SERIES • User’s manual...

  • Page 3: Foreword

    The SOPIX series comprises the SOPIX, SOPIX², SOPIX inside and SOPIX² inside systems. This user’s manual applies to each of the systems in the SOPIX series. To optimise the use of this device, we recommend you read the owner’s manual thoroughly before using a SOPIX series system and carefully follow the instructions contained in this manual.

  • Page 4: Digital X-Ray System Introduction

    2.1. FUNCTIONS AND PERFORMANCE The SOPIX series digital X-ray imaging systems are intended to be used by a dental practitioner. The sensor (located in the patient’s mouth just like a silver fi lm) captures the X-rays produced by the generator. Then it transmits this data to the computer to display the X-ray image on the screen.
  • Page 5 • Optional: the positioning kit. The SOPIX series systems are packaged in a custom carton. This carton should be kept for future possible transportation. For more details about these products, please refer to our catalogue or contact our commercial service.

  • Page 6: Precautions For Use

    CAUTION: • Do not open the system and do not try to take it apart or modify it, in order to avoid any risk of malfunctioning of the SOPIX series system. • Always connect the device to a USB port to avoid any risk of malfunctioning of the SOPIX series system. For more information, please refer to section 3.5 of this manual.
  • Page 7 • DO NOT hold the sensor with clamp forceps. • DO NOT hold the sensor by the connecting cable. • DO NOT roll over or walk on the connecting cable. • DO NOT use abrasive product to clean the sensor. SOPIX SERIES • User’s manual...
  • Page 8 It is advisable to dedicate a High Speed USB channel to the digital X-ray system. This will ensure that the performance and the transmission speed of the SOPIX series system data will not be affected by the fact that another peripheral is on the same channel.

  • Page 9: Standards And Regulations

    Medical device vigilance Like any medical device, SOPIX series systems are subject to medical device vigilance provisions; any serious malfunction should then be the subject of a report to the competent authorities and to the manufacturer as soon as possible and as precisely as possible.
  • Page 10 Guidance and manufacturer’s declaration – electromagnetic emissions The SOPIX series systems are intended for use in the electromagnetic environment specifi ed below. The customer or the user of the SOPIX series systems should assure that it is used in such an environment. Emissions test...
  • Page 11 Guidance and manufacturer’s declaration – electromagnetic immunity The SOPIX series systems are intended for use in the electromagnetic environment specifi ed below. The customer or the user of the SOPIX series systems should assure that it is used in such an environment. IEC 60601...
  • Page 12 Guidance and manufacturer’s declaration – electromagnetic immunity The SOPIX series systems are intended for use in the electromagnetic environment specifi ed below. The customer or the user of the SOPIX series systems should assure that it is used in such an environment. Immunity test...
  • Page 13 fi xed RF transmitters, an electromagnetic site survey should be considered. If the measured fi eld strength in the location in which the SOPIX series systems are used exceeds the applicable RF compliance level above, the SOPIX series systems should be observed to verify normal operation.
  • Page 14 E N G L I S H 4.2. KEY TO STANDARDISED SYMBOLS The symbols appearing on the connection housings identify the SOPIX series systems according to the international standards IEC 60601-1 and IEC 60417. Sensor sleeve for single use. “Type BF applied part”.

  • Page 15: System Configuration

    5.1. COMPUTER SYSTEM REQUIREMENTS To use one of the SOPIX series systems, you must make sure the computer and its peripherals do not have any limitation of use that might affect personal safety. It should also meet the following requirements: Windows®...
  • Page 16 The SOPIX series systems are provided with the Sopro Imaging dental imaging software, running in Windows® and MAC®. It is versatile software that captures, processes, and fi les the X-ray images taken with the SOPIX series systems, but also allows network sharing of your data.

  • Page 17: Installation And Connection

    Refer to the Sopro Imaging installation manual to be found on the Sopro Imaging software CD-ROM in the document directory. 6.3. SOPIX SERIES SYSTEM INSTALLATION Before installing the SOPIX series digital X-ray system, make sure the computer is connected to a correctly earthed socket. Now, go through the following steps: CAUTION: Insert the Sopro Imaging software CM-ROM into the CD drive in order to install the drivers.
  • Page 18 • The elements connected to SOPIX series systems should not be placed within the patient’s environment, in compliance with standard IEC 60601-1-1 (EN 60601-1-1). The minimum horizontal distance between the patient and these elements is 1.5 meters.

  • Page 19: Use

    E N G L I S H The SOPIX series systems are intended to be used by a dental practitioner. Their use does not require any special training. Consult the instructions in this manual. 7.1. ACQUISITION OF AN X-RAY IMAGE First, switch on the PC on which the SOPIX series system is installed and launch the imaging software (Sopro Imaging, for example).
  • Page 20 If the sensor sleeve is torn when examining a patient or if the SOPIX series sensor has been contaminated when withdrawing the sensor sleeve, it is essential to fully disinfect the SOPIX series sensor and the fi rst 40cm of cable. In order to do this, please refer to the table in the “sensor maintenance”...

  • Page 21: Maintenance

    MAINTENANCE NTEN NTEN The SOPIX series digital X-ray systems do not need any maintenance if they are used according to the manufacturer’s directions for use and cleaning instructions. Only Sopro’s Qualifi ed technician can proceed to service. NOTE : Quality control: European legislation in force in certain European countries -notably Germany -which requires a check (once per month) of the quality of the sensor(s) by means of a test card specially designed for the purpose.
  • Page 22 Use of these chemicals may subject plastic parts to risk of deterioration. CAUTION: Do not directly spray disinfectant products onto SOPIX series sensors. WARNING: In order to prevent any risk of cross-contamination, always observe the necessary precautions and hygiene measures while handling SOPIX series systems and sensor sleeves.
  • Page 23 Aldehyde – Pierre Rolland. cleaning the sensor. CAUTION: It is imperative to comply with the sensor precautions for use. Please refer to section 3 of this manual “Precautions for use”. SOPIX SERIES • User’s manual...

  • Page 24: After-Sales Service

    9.1. LIMITED LIABILITY The SOPIX series was designed to ensure the acquisition of dental X-ray images, their transfer in the form of computer data, as well as their storage. Nevertheless, SOPRO Company shall not be liable for inappropriate use of this equipment or for any loss of stored data in the computer system due to a problem of use or any possible technical problem.
  • Page 25 3. Stabilize the generator head. stabilized when the timer was activated. In case of a problem not mentioned above, please contact your dealer who will undertake to uninstall and return the SOPIX series system to the SOPRO after-sales department. NOTE : No maintenance should be performed by a third party.

  • Page 26: Technical Features

    Total weight: 180 g Liquid penetration: IPX0 (protection index) Liquid penetration: IPX0 (protection index) USB cable length: 3 m USB cable length: 5 m * Scintillator: GADOX for SOPIX & SOPIX INSIDE, CSI for SOPIX² & SOPIX² INSIDE. SOPIX SERIES • User’s manual...
  • Page 27 • Not suitable for use in the presence of a fl ammable anaesthetic mixture with air, oxygen or nitrous oxide. • Complies with the European Medical Devices Directive 93/42/EEC. • Complies with the standard IEC60601-1 Ed3, ES60601-1 and CSA - C22.2 No. 60601-1 : 08. SOPIX SERIES • User’s manual...
  • Page 28 SOPRO a company of ACTEON Group • ZAC Athélia IV • Avenue des Genévriers • 13705 LA CIOTAT cedex • FRANCE Tel +33 (0) 442 980 101 • Fax +33 (0) 442 717 690 • E-mail: info@sopro.acteongroup.com • www.acteongroup.com...

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