Keeler KSL-H Instructions For Use Manual

Slit lamp

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SLIT LAMP
INSTRUCTIONS FOR USE
Digital IFU supplement

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Summary of Contents for Keeler KSL-H

  • Page 1 & SLIT LAMP INSTRUCTIONS FOR USE Digital IFU supplement...
  • Page 2 Copyright © Keeler Limited 2015. Published in the UK 2015. K S L - H A N D K S L - Z b y K E E L E R...
  • Page 3: Table Of Contents

    CONTENTS Please click on the contents to go straight to your chosen section or Introduction navigate by using the ‘Next’ and ‘Back’ buttons to the right. Clicking on Symbols used in these Instructions for Use ‘Home’ will bring you back to this page. including the Slit Lamp and packaging Indications for use Intended use/purpose of instrument...
  • Page 4: Introduction

    FDA cleared imaging software installed on a medically approved PC. For performance from this precision optical device. detailed instructions on use of the Keeler Desktop Slit Lamp please refer to the Slit Lamp Manual EP59-70040. This manual should be read in conjunction with the Keeler Slit Lamp H- series IFU (EP59-70040) or Keeler Slit Lamp Z-series IFU (EP59- 70043).
  • Page 5: Symbols Used In These Instructions For Use

    SYMBOLS USED IN THESE INSTRUCTIONS FOR USE AND THE PACKAGING OF THE UNIT: Manufacturer’s name and address Date of manufacture The CE mark on this product indicates it has been tested to and conforms Mandatory action sign with the provisions noted within the 93/42/EEC Medical Device Directive Follow Instructions for Use This way up Optical radiation hazard...
  • Page 6: Indications For Use

    This Keeler Slit Lamp can either be mounted onto a custom table top supplied by Keeler or can be mounted on a third parties table top (refraction unit) by intended for use in eye examination of the anterior eye segment, from suitably trained technicians.
  • Page 7: Safety

    The retinal exposure dose for a photochemical hazard is a product of the radiance and the exposure time. If the value of radiance were reduced in half, The relative spectra output for Keeler Slit Lamp H-series and Z-series twice the time would be needed to reach the maximum exposure limit.
  • Page 8 • Care should be taken when handling halogen bulbs. Halogen bulbs can shatter • Check your Keeler product for signs of transport / storage damage prior to use. if scratched or damaged. • Do not use in the presence of flammable gases / liquids, or in an oxygen rich •...
  • Page 9: Cleaning And Disinfection Instructions

    Surfaces must be carefully hand-dried using a clean non- shedding cloth. • Keeler digital KSL cannot be used in the vicinity of sources known to cause electromagnetic disturbance (magnetic resonance imaging, computed d Safely dispose of used cleaning materials.
  • Page 10 INSTALLATION OF DIGITAL UNIT For ‘Digital Ready’ variants of the Keeler Slit Lamp a Digital Camera Fit the digital camera assembly to the rear of the magnification Assembly (DCA) must be purchased separately, contact Keeler or your block and tighten the securing knob to hold it in place.
  • Page 11 Rotate the swing arm to either side of the unit, and with a suitable Connect the shorter USB cable (3020-P-7107) to the socket on philips screw driver remove the cable channel cover plate. the underside of the DCA and to the appropriate socket on the USB hub located on the Slit Lamp base.
  • Page 12 PC long end short end KSL-H SERIES SLIT LAMP Clip the auxiliary diffuser and blue filter in place on the Slit Lamp tower upright posts, above the level of the mirror. Align the slot to the flattened post section.
  • Page 13: Controls

    CONTROLS BACKGROUND ILLUMINATION BACKGROUND ILLUMINATION CAPTURE BUTTON ADJUSTMENT, KSL-H SERIES ADJUSTMENT, KSL-Z SERIES Press once to ‘freeze frame’ Use image review buttons to select best frame SLIT LAMP SLIT LAMP Press again to capture selected frame KEYBOARD SHORTCUTS Ctrl + Alt + Shift :...
  • Page 14: Electromagnetic Emissions

    ELECTROMAGNETIC EMISSIONS Guidance and manufacturer’s declaration – electromagnetic emissions Guidance and manufacturer’s declaration – electromagnetic immunity The Digital Camera Assembly is intended for use in the electromagnetic The Digital Camera Assembly is intended for use in the electromagnetic environment specified below. The customer or user of the Digital Camera environment specified below.
  • Page 15 Guidance and manufacturer’s declaration – electromagnetic immunity Recommended separation distances between portable and mobile RF The Digital Camera Assembly is intended for use in the electromagnetic communications equipment and the Digital Camera Assembly environment specified below. The customer or user of the Digital Camera The Digital Camera Assembly is intended for the use in an electromagnetic Assembly should assure that it is used in such an environment.
  • Page 16: Technical Specification

    TECHNICAL SPECIFICATION POWER SUPPLY Part number Switch Mode, (100V-240V input) +/- 10% multi plug 3020-P-5020/ Power supply unit compliant to EN60601-1 EN 61000-6-2, EN 61000-6-3 3020-P-7033 Power supply output 24V DC: 2.2 amps must be IEC/EN 60601 compliant DIGITAL SYSTEM CAMERA Complies with Electrical Safety (Medical) BS EN 60601-1 Camera...
  • Page 17: Contact, Packaging And Disposal Information

    CONTACT, PACKAGING AND DISPOSAL INFORMATION MANUFACTURER INDIA OFFICE DISPOSAL OF OLD ELECTRICAL AND ELECTRONIC EQUIPMENT Keeler Limited Keeler India (Applicable in the European Union and other European Countries with Clewer Hill Road Halmer India Pvt. Ltd. separate Collection Systems). Windsor...

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