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CEFLA Myray hy-scan Manual

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97050945
Rev. 04
2018.12
EN

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Summary of Contents for CEFLA Myray hy-scan

  • Page 1 97050945 Rev. 04 2018.12...

  • Page 2: Table Of Contents

    ITALIANO Contents 1. FOREWORD................................3 1.1. DESCRIPTION OF THE MANUAL ........................4 1.2. BOX CONTENTS ..............................4 2. GENERAL WARNINGS ............................. 5 2.1. STYLISTIC CONVENTIONS ..........................6 2.2. INTENDED USE ..............................6 2.3. CLASSIFICATION AND REFERENCE STANDARDS ..................7 2.4. ENVIRONMENTAL CONDITIONS ........................8 2.5.

  • Page 3: Foreword

    1. FOREWORD The hy-scan system is a system for acquiring and processing intraoral digital images that can be used with all intraoral X-ray systems. In order to manage the intraoral images, it is essential to use a personal computer and an image viewer program. The hy-scan system was developed to simplify the process of acquiring and viewing intraoral images on a digital screen.

  • Page 4: Description Of The Manual

    1.1. DESCRIPTION OF THE MANUAL This Manual is an essential consultation tool and contains important information and instructions for the use of the phosphor plate acquisition system. These instructions describe how to properly and safely use the device. Carefully read and familiarise yourself with the entire contents of the Manual before attempting to use the product.

  • Page 5: General Warnings

    Patient or operator safety-related warnings. Important information on product use. The phosphor plate acquisition system and the relevant software iCapture are manufactured by Cefla s.c.– Via Selice Prov.le 23/A 40026 Imola (Italy), hereinafter referred to as the Manufacturer, which is the manufacturer and distributor in compliance with the EC Medical Device Directive.

  • Page 6: Stylistic Conventions

    2.1. STYLISTIC CONVENTIONS The following symbols may be found on the device and in the Manual: It is necessary to read the user's manual before using the device. Equipment in compliance with essential requirements of council directive 93/42/EEC and subsequent changes, among which Directive 2007/47/EC (Class IIa equipment).

  • Page 7: Classification And Reference Standards

    2.3. CLASSIFICATION AND REFERENCE STANDARDS Classification of MEDICAL DEVICES. Equipment classification according to rule 16 indicated in annex IX of Directive 93/42/EEC as later amended, among which Directive 2007/47/EC: class IIa. IEC 60601-1 classification. Type of protection against electric shocks: CLASS I Degree of protection, IP: IPX0...

  • Page 8: Environmental Conditions

    2.4. ENVIRONMENTAL CONDITIONS During the transport and the storage it is necessary to respect the conditions indicated below. Transport and storage temperature: from -20° to +60° (Celsius) Humidity conditions for transport and storage: max 95% (non-condensing) Pressure: 710 – 1060 hPa The equipment must work in rooms with the following environmental conditions: Operating temperature: from +10°...

  • Page 9: Warranty

    2.6. WARRANTY The Manufacturer stands behind its products warranting safety, reliability and performance. WARNING: The Manufacturer shall not be held liable for any personal injury or property damage arising from failure to heed the following clauses. The warranty is valid only under the following terms: closely observe the conditions specified in the warranty certificate itself;...

  • Page 10: Safety Guidelines

    2.7. SAFETY GUIDELINES Carefully read the procedures described in this manual; Do not forget to turn off the main switch on the equipment before leaving the surgery; This equipment must be stored properly so that it is kept in top working order at all times; The user must be present at all times when the equipment is turned on or ready for start-up.

  • Page 11: Electrical Safety Device

    2.8. ELECTRICAL SAFETY DEVICE The system is designed in compliance with regulations regarding electrical safety. Always observe the following safety precautions: Do not place containers containing liquid near the system. Do not tamper with the computer or the connected equipment. Only use original cables and accessories that come with the system.
  • Page 12 Guidance and Manufacturer's declaration - Electromagnetic immunity The device is designed to operate in the specified electromagnetic environment. The customer or the user of the device must ensure its use in an electromagnetic environment with the following features: IEC 60601-1 Immunity test Conformity Electromagnetic Environment...
  • Page 13 Guidance and Manufacturer's declaration - Electromagnetic immunity The device is designed to operate in the electromagnetic environment specified below. The customer or user of the device should ensure that is used in such environment. Immunity Immunity Immunity Immunity test test test test The RF communication devices (portable and mobile)

  • Page 14: Protection Against Radiation

    2.10. PROTECTION AGAINST RADIATION The phosphor scanner and intraoral plates must be used together with an intraoral X-ray system. As such, the system exposes the patient and the operators to the risks deriving from radiation. It must be used in compliance with the safety regulations set out in the radiation protection standards in force in the country of use.

  • Page 15: Hygiene Procedures For Patient Protection

    2.11. HYGIENE PROCEDURES FOR PATIENT PROTECTION Disposable hygienic protections are the main protection means against cross contamination between patients. In order to prevent the transmission of infectious diseases between patients, it is essential to always use disposable covers supplied with phosphor plates. Disposable hygienic protections must be stored in a dry and clean area and must not be exposed to direct sunlight or UV radiation.

  • Page 16: Description Of The Equipment

    3. DESCRIPTION OF THE EQUIPMENT The product consists of the following components: Phosphor scanner. • Power supply. • Power cable. • USB cable. • USB key to install software, and electronic • user's manual. Phosphor plates. • Light covers. • Disposable infection control sheaths.
  • Page 17 The scanner can be positioned in two different ways: horizontally, on a flat surface, for example on a table; • vertically, leaning against a wall, using the appropriate wall support. • Phosphor scanner in a vertical position, with wall Phosphor scanner on a horizontal surface. bracket.

  • Page 18: Setting Up The Device

    4. SETTING UP THE DEVICE Some simple operations have to be performed before attempting to use the device for the first time: 1) Remove the system from the original packaging. The phosphor scanner can be placed on a horizontal surface or vertically, fixed to the wall by means of suitable support.

  • Page 19: Functioning

    5. FUNCTIONING 5.1. PHOSPHOR PLATE PREPARATION The phosphor plate stores energy from the X-rays that strike it, and is able to return this energy as a result of laser excitation. Using the scanner, the re-emitted light is converted into an image. The phosphor plate has an active side (blue) and an inactive side (black).

  • Page 20: Phosphor Plate Exposure

    5.2. PHOSPHOR PLATE EXPOSURE Place the phosphor plate in the patient's mouth, in the position required to obtain the required image. The rear part of the hygienic cover (the part with the seal) must be away from the X-ray source. It is recommended to use the optional centring devices - that can be purchased separately from your local distributor - to facilitate the positioning of the plate and...

  • Page 21: Exposure Times

    EXPOSURE TIMES For RX DC X-ray units manufactured by Cefla S.C. it is recommended to use a sensitivity value equal to F15 with default pre-setting left at 8mA. Exposure times, kV and mA values will be automatically set according to the anatomical area selected on the X-ray unit by the operator.

  • Page 22: Phosphor Plate Reading

    5.3. PHOSPHOR PLATE READING In the extraction stages of the phosphor plate from light cover, do not expose the plate to light. After exposure of the plate, it is recommended to immediately proceed with its reading. Do not exceed 10 minutes of waiting time.
  • Page 23 4. As soon as the plate stops and the green LED flashes, decrease the pressure of your fingers on the light cover and remove the latter, leaving only the plate inserted into the phosphor scanner slot. 5. At this point, the phosphor plate will be engaged by the magnetic drive system and will be automatically dragged inside the scanner for scanning.

  • Page 24: Led Sequence

    5.4. LED SEQUENCE Through the software, the device can alert the operator about the different statuses of the system, such as errors, functions, or other. The different statuses of the system can also be identified through the front-mounted LEDs. The following table shows all situations that may occur during a normal work sequence. NORMAL OPERATION LED COLOUR DESCRIPTION...

  • Page 25: Maintenance

    6. MAINTENANCE The device does not contain parts that can be repaired directly by the user. In the event of a malfunction, do not attempt to carry out maintenance operations, but directly contact your local distributor at the numbers indicated in the warranty certificate.

  • Page 26: Cleaning And Disinfection

    It is therefore important not to leave the product on the surfaces longer than the time specified by the manufacturer. It is recommended to use the specific medium-level disinfectant, STER 1 PLUS (CEFLA s.c.), which is compatible with: Coated surfaces and plastic parts.

  • Page 27: Technical Data

    8. TECHNICAL DATA Characteristics System classification MDD 93/42 – DL46/1997 Ann. IX Rule 16 Certification and class Classification: IIa Dimensions and weight of rack Weight 4.5 Kg (with no power supply) Height 176.3 mm Depth 263.9 mm Width 133 mm Technical specifications Pixel size 30 µm...

  • Page 28: System Pc Requirements

    8.1. SYSTEM PC REQUIREMENTS The PC on which the phosphor scanner system will be installed and all its related devices must meet the requirements for additional equipment, as specified in IEC 60601-1. The minimum requirements that your PC must satisfy to ensure proper and complete use of the system are: Characteristics Personal Computer COMPONENT...

  • Page 29: Troubleshooting

    9. TROUBLESHOOTING WARNING! Do not try to solve the problem if the need for intervention by a specialist technician is indicated. This could cause injury to the operator or compromise the integrity of the system. Problem Possible cause Possible Solution application Check PC characteristics against the minimum installation...

  • Page 30: Identification Plate

    10. IDENTIFICATION PLATE WARNING! Do not remove the identification plates that accompany the product and its accessories. As illustrated in the figure, the plate with the product identification data is affixed close to the power connectors of the phosphor scanner. For a thorough explanation of the symbols on the identification plate, see 2.1 “Stylistic conventions”.