Medi-Plinth GP Gynaecology Plinth GY02ES/+EB01/+EC Instructions For Use Manual

Medi-Plinth GP Gynaecology Plinth GY02ES/+EB01/+EC Instructions For Use Manual

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Part Number: SD01004 Iss 01 11/2023
GP Gynaecology Plinth
Instructions for use
GY02ES/+EB01/+EC, GY02ET/+EB01/+EC, GY02EF/+EB01/+EC

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Summary of Contents for Medi-Plinth GP Gynaecology Plinth GY02ES/+EB01/+EC

  • Page 1 Part Number: SD01004 Iss 01 11/2023 GP Gynaecology Plinth Instructions for use GY02ES/+EB01/+EC, GY02ET/+EB01/+EC, GY02EF/+EB01/+EC...
  • Page 2: Table Of Contents

    Part Number: SD01004 Iss 01 11/2023 Contents DEVICE DESCRIPTION ..................... 3 INTENDED USE ......................3 INDICATIONS FOR USE .................... 3 INTENDED USER AND USER TRAINING ..............3 PATIENT TARGET GROUP(s) ................... 3 PERFORMANCE CHARACTERISTICS ..............3 EXPECTED CLINICAL BENEFIT ................3 CONTRAINDICATION ....................
  • Page 3: Device Description

    1. DEVICE DESCRIPTION The Medi-Plinth GP Gynaecological Plinth consists of a platform mounted on a stable frame designed to support a maximum weight of 260 kg and fitted with an electric elevation system.
  • Page 4: Warnings & Cautions

    Before using any plinth/couch, please familiarize any operator with this user manual. All product IFU’s can be found on our website: www.medi-plinth.co.uk/IFU. The QR code located next to the serial number on the product will directly link you to the IFU also. Should you require a printed hardcopy of the IFU, please email sales@medi-plinth.co.uk...
  • Page 5 • Other than for routine daily procedures listed in the troubleshooting in this manual, any maintenance or repairs to Medi-Plinth products must be carried out by an authorised, competent and Medi-Plinth approved engineer who has been trained and certified by Medi-Plinth Equipment Ltd.
  • Page 6: Potential Adverse Effects

    11. REPORTING OF SERIOUS INCIDENTS: If a serious incident is suspected from using the plinths/ couches, report the details of the Incident to Medi-Plinth Equipment via the online complaint form https://www.medi- plinth.co.uk/contact-us, by email to Sales@medi-plinth.co.uk or by phone number 01473 212010 and to the local Health Authority in your country.
  • Page 7 Part Number: SD01004 Iss 01 11/2023 • Engage the plinth wheels system on both ends of the plinth, by pushing the wheel levers downwards at either end. This will raise each end of the plinth on to its wheels. The plinth can now be easily moved for cleaning or relocation purposes.
  • Page 8: Operating Environment

    Part Number: SD01004 Iss 01 11/2023 Removeable Foot Section (Standard Feature) To secure the section- both hands are required. Align the two prongs of the foot section into sockets on the underside of the seat section on the plinth. Slowly push the foot section in fully and tighten the two hand wheels to secure the section in place.
  • Page 9: Safe Operation Of Plinth/Couch

    The plinth will be packed and protected to ensure no damage occurs during normal transportation of goods. Medi-Plinth plinths and couches must be stored in a dry environment, protected against ground moisture, away from direct sun or UV exposure and other direct sources of heat. If held in storage for long periods, a full service should be completed before plinth/couch is put back into service.
  • Page 10: Decontamination

    Part Number: SD01004 Iss 01 11/2023 Medi-Plinth takes no responsibility for damage incurred while cleaning. Listed below are recommended/suggested cleaning methods. Always patch test a cleaning method in a hidden area first. If you are not sure, please contact Medi-Plinth customer support.
  • Page 11: Troubleshooting

    Part Number: SD01004 Iss 01 11/2023 It is recommended that the Medi-Plinth products are serviced once per year. Particularly if in constant use. Regular service and maintenance are essential to maintain both the safety and reliability of the plinth/couch. All service and maintenance of the Medi-Plinth products must be completed by an authorised, competent and Medi-Plinth approved engineer who has been trained and certified by Medi-Plinth Equipment Ltd.
  • Page 12 Part Number: SD01004 Iss 01 11/2023 have the serial number of the plinth/couch you are enquiring about to hand before making contact so we can help you more efficiently. Problem: Cause: Solution: • The adjustable foot is not set up Uneven floor correctly.
  • Page 13: Decommissioning And Disposal

    All spares can be purchased by the user from Medi-Plinth Equipment directly. Please contact the Medi-Plinth Equipment Limited sales team (sales@medi-plinth.co.uk) for further information.
  • Page 14: Symbols Used On Labelling

    For any further information on this product, regarding spares, warranty, service, or maintenance information, please contact Medi-Plinth or your distributor. Medi-Plinth reserves the right to examine the plinth/couch before making any repairs to determine the nature or origin of the defect and whether it is covered by the guarantee. Medi- Plinth will not be responsible for damages caused by the time the plinth/couch is out of service.
  • Page 15 Part Number: SD01004 Iss 01 11/2023 Serial Number Medical Device Temperature Limit Medi-Plinth serial number label. Medi-Plinth IFU Download label. Pg. 15...
  • Page 16 Reproduction, adaptation, or translation without prior written permission is prohibited, except as allowed under the copyright laws. Thank you for choosing a Medi-Plinth Equipment Limited plinth/couch. Should you require any further details on the information contained in these instructions please contact us at: Company Registration No: 06204253 Medi-Plinth is an ISO 13485:2016 accredited company.

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