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USER'S MANUAL
EN • NOCMEN010A • 03/2021

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Summary of Contents for Owandy Radiology OWANDY-CAM HD

  • Page 1 USER’S MANUAL EN • NOCMEN010A • 03/2021...
  • Page 2: Table Of Contents

    SAFETY INSTRUCTIONS................4 REGULATORY REQUIREMENTS..............6 INSTALLATION................... 12 CONNECTING TO A COMPUTER..............13 DESCRIPTION OF THE CONNECTION BOXES........... 15 MAINTENANCE..................17 AFTER-SALES SERVICE................19 10 10 TECHNICAL FEATURES................22 Owandy-Cam HD • User’s manual...
  • Page 3: Foreword

    WARNING: the term WARNING refers to the incidents likely to disturb the smooth running of the imaging system. NOTE : the term NOTE highlights particular points in order to facilitate the system maintenance or to clarify important information. Owandy-Cam HD • User’s manual...
  • Page 4: Camera Introduction

    This fluorescence Imaging device is composed of a handpiece (Owandy-Cam HD) and a connection box (MINI DOCK USB2) as well as various accessories necessary for it to work.
  • Page 5: Safety Instructions

    Therefore avoid maintaining this emission area in contact with the patient’s mouth. • The camera is a product using group 1 LEDs according to IEC 62471. To avoid any ocular risk do not look directly at the light. Owandy-Cam HD • User’s manual...
  • Page 6 Modification of the product, without the permission of the manufacturer, is prohibited. CAUTION: If the medical equipment is changed, an appropriate control and test should be performed to ensure that the medical equipment still can be used safety. Owandy-Cam HD • User’s manual...
  • Page 7: Regulatory Requirements

    • Reposition the product according to the receiver. • Take the computer away from the receiver. The Owandy-Cam HD camera is designed and tested to be used in a home environment, class B Group 1, according to CISPR11 standard. 4.3. MEDICAL DEVICE VIGILANCE As with any medical device, this device is subjected to medical device vigilance dispositions;...
  • Page 8 For more details about the device treatment, recuperation and recycling, please contact your dental device distributor (or failing that, www.owandy.com), so that you can be informed of the procedure. Owandy-Cam HD • User’s manual...
  • Page 9 E N G L I S H 4.5. ELECTROMAGNETIC COMPTABILITY Guide and declaration of the manufacturer - electromagnetic emissions Owandy-Cam HD device is intended to be used in the electromagnetic environment specified below. The user should make sure it is used in this environment. Emission trial...
  • Page 10 E N G L I S H Guide and declaration of the manufacturer - electromagnetic immunity Owandy-Cam HD device is intended to be used in the electromagnetic environment specified below. The user should make sure it is used in this environment.
  • Page 11 E N G L I S H Guide and declaration of the manufacturer - electromagnetic immunity Owandy-Cam HD device is intended to be used in the electromagnetic environment specified below. The user should make sure it is used in this environment.
  • Page 12 Owandy-Cam HD device Owandy-Cam HD device is intended to be used in an electromagnetic environment in which the irradiated RF disturbances are checked. The user of Owandy-Cam HD device can help to avoid electromagnetic interference by maintaining a minimal distance between the portable and mobile RF communication devices (transmitters) and the recommended Owandy-Cam HD device such as recommended below, depending on the maximum output power of the communication device.
  • Page 13: Installation

    You can install a connection box near each dental chair (no limitation). You will just have to transport the handpiece from one chair to the other. The handpiece holder is intended to maintain the connecting cable connector when the cable is not linked to the handpiece. Owandy-Cam HD • User’s manual...
  • Page 14: Connecting To A Computer

    CONNECTING TO A COMPUTER 6.1. REQUIRED CONFIGURATION FOR THE COMPUTER To use the Owandy-Cam HD device, you must make sure the computer and its peripherals do not have any usage limitation that could concern personal safety. It should also meet the following requirements: Windows®...
  • Page 15 Refer to the QuickVision user manual located on the USB key in the « Document » directory. 6.4. IMAGING SOFTWARE CONFIGURATION WITH THE CAMERA Refer to the QuickVision user manual located on the USB key in the « Document » directory. Owandy-Cam HD • User’s manual...
  • Page 16: Description Of The Connection Boxes

    This camera has a has a digital USB 2.0 output that can be connected to a computer USB2 port. 7.3. IDENTIFICATION The indications born on the boxes identify the Owandy-Cam HD device according to the international standards IEC 60601-1, IEC 60601-2-18 and IEC 60417.
  • Page 17 For medical devices, this symbol is associated to the manufacturer name and address. Product compliance according to the European directive 93/42/EEC relative to medical devices. Electronic user instructions. The devices that connect to USB outputs should comply with IEC 60950 standard. Owandy-Cam HD • User’s manual...
  • Page 18: Maintenance

    E N G L I S H MAINTENANCE The camera Owandy-Cam HD does not need any maintenance if it is used according to the manufacturer’s use and cleaning instructions. Before first using it, it is imperative to follow the complete disinfecting procedure.
  • Page 19 Do not rinse. then wipe the equip- Do not immerse ment until visible clean- in a disinfecting liness is obtained. liquid. Allow to dry in the open air. Carefully close the pac- kaging box. Owandy-Cam HD • User’s manual...
  • Page 20: After-Sales Service

    9.1. WARRANTIES OWANDY RADIOLOGY ensures its products to be free from material and manufacturing defects for a period of two (2) years from the date of purchase, with 5 years warranty extension in option. This warranty does not apply to misused, modified, untended, or accidentally damaged products, or products subject to abnormal use and handling conditions.
  • Page 21 (brightness, contrast, satura- not satisfactory. tion, etc.). Please refer to user’s manual. An image displays, but it is • Hygienic protector. Check the hygienic protector is correctly not really clear (blurry) positioned on the camera head. Owandy-Cam HD • User’s manual...
  • Page 22 If any material we sent was damaged during transportation, the repair charges will be billed either to the carrier (if the discrepancies were made within the period) or to the recipient. Check as soon as possible that all material is correctly working. Owandy-Cam HD • User’s manual...
  • Page 23: Technical Features

    • Handpiece weight: 55 g. MINI DOCK USB2 • Cable length: 2,5 m. • 1 digital USB output 2.0. • Controller dimensions: L : 64,50 ; W : 26 ; H : 11 mm. • Dock weight: 97 g. Owandy-Cam HD • User’s manual...
  • Page 24 • Not adapted to the use in presence of an anaesthetic mixture flammable with air, oxygen or dinitrogen monoxide. • Complies with the European directive 93/42/EEC. • Complies with IEC60601-1 standard. • Complies with IEC60601-2-18 standard. • Complies with UL 60601-1 et CSA 60601-1 standard. Owandy-Cam HD • User’s manual...
  • Page 25 SOPRO OWANDY RADIOLOGY ZAC Athélia IV - Avenue des Genévriers 2 rue des vieilles vignes 13705 LA CIOTAT cedex - FRANCE 77183 Croissy-Beaubourg - FRANCE Tel +33 (0)4 42 98 01 01 Tel +33 (0)1 64 11 18 18 info@owandy.com - www.owandy.com...

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