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Ovesco remOVE DC Impulse Instructions For Use Manual

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Instructions for use
English
Ref. no. 400.01

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Summary of Contents for Ovesco remOVE DC Impulse

  • Page 1 Instructions for use English Ref. no. 400.01...
  • Page 2 DC Impulse Instructions for use English; Revision 9 Date 26.02.2020 Ref. no. 400.01 Ovesco Endoscopy AG Friedrich-Miescher-Straße 9 72076 Tübingen Germany +49 (0)7071-98979-160 service@ovesco.com www.ovesco.com...

  • Page 3: Table Of Contents

    Contents How to use these instructions for use ....................4 Scope of supply ........................... 5 Accessories and replacement parts ....................5 Product description ..........................6 Intended use / indication ........................8 Contraindications ..........................8 Complications ............................8 General information ..........................9 Warnings and precautions ........................

  • Page 4: How To Use These Instructions For Use

    Failure to observe this warning can result in injury to users and patients or damage to the product or WARNING accessories. Particularly important contents to be taken into account NOTE when using the product. 4 / 32 Ovesco; remOVE DC Impulse; English; Revision 9; 26.02.2020...

  • Page 5: Scope Of Supply

    C DC cable D Power cable E Test instrument for electrical tests * The front view of the remOVE DC Impulse shown may differ slightly from the actual front of the device from serial number 0225. 3 Accessories and replacement parts When purchasing accessories or replacement parts, please ensure that only original components or products that the manufacturer has indicated are compatible are used.

  • Page 6: Product Description

    3 Status display: Charge level / Ready for use / Fault 4 Foot-activated switch connection 5 DC cable connection * The front view of the remOVE DC Impulse shown may differ slightly from the actual front of the device from serial number 0225. 6 / 32...
  • Page 7 Figure 3: Rear view of the remOVE DC Impulse 6 Nameplate 7 Power supply connection 8 Fuse Figure 4: Nameplate of the remOVE DC Impulse (The nameplate design may differ slightly from the above image for devices up to serial number 0224).

  • Page 8: Intended Use / Indication

    DC Impulse, destruction of the remOVE DC Cutter and permanent connection of the remOVE DC Cutter with the object. 6 Contraindications The remOVE DC Impulse must not be used if flexible endoscopic procedures and/or the fragmentation and removal of OTSC ®...

  • Page 9: General Information

    (see Chapter 15 and Chapter 16.3). Damage to the remOVE DC Impulse Prior to using the remOVE DC Impulse, please check that all components are present and that there are no defects. Incomplete or faulty components must be replaced immediately. Defective or missing components may result in the product malfunctioning.
  • Page 10 Compatibility of the remOVE DC Impulse with magnetic resonance imaging (MRI): Not MR Safe The remOVE DC Impulse is not MRI compatible. It must not be used in an MRI environment. 10 / 32 Ovesco; remOVE DC Impulse; English; Revision 9; 26.02.2020...

  • Page 11: Components And Products Required For Use

    (Includes remOVE DC Cutter (G), remOVE SecureCap 12/14 (H), remOVE Grasper (I), remOVE Shield (J)) * The front view of the remOVE DC Impulse shown may differ slightly from the actual front of the device from serial number 0225. 11 / 32...

  • Page 12: Preparation

    Please note that local laws take precedence over the aforementioned normative requirements. When setting up the remOVE DC Impulse, ensure that the user has unobstructed, direct view of the status display.

  • Page 13: Use

    LEDs flash green. The number of LEDs indicates the charging progress. If the remOVE DC Impulse has not been in operation for more than two days, a complete charge will take approx. 10 minutes. If the remOVE DC Impulse was in operation within the last two days, the charging time may be shorter.
  • Page 14 Even if the product is used as intended, side effects may occur. For this reason, Ovesco products should only be used by persons who are qualified and trained to use the product for its intended purpose.
  • Page 15 Figure 10: With the clip fragment gripped by the remOVE Grasper in the remOVE SecureCap 10. Switch off the remOVE DC Impulse by pressing the ON/OFF switch. 15 / 32 Ovesco; remOVE DC Impulse; English; Revision 9; 26.02.2020...

  • Page 16: Notes On The Workings Of The Product

    This internal energy storage system is charged by the remOVE DC Impulse before generating a DC pulse. The remOVE DC Impulse is designed so that a DC pulse can only be triggered when there is sufficient contact with a clip segment. Sufficient contact is indicated by an acoustic signal.

  • Page 17: Cleaning And Disinfection

    Status display flashes orange in the event of a fault. If a fault is indicated on the remOVE DC Impulse, the acoustic contact detection between instrument and clip is deactivated. A DC pulse can no longer be triggered and the internal energy storage system of the remOVE DC Impulse is no longer charged.

  • Page 18: Transport, Shipping And Storage Conditions

    Ovesco shall not assume any liability for such transport damage. Storage Store the remOVE DC Impulse in a dry, clean location, taking into consideration the relevant storage conditions. We recommend storing the remOVE DC Impulse in the undamaged original packaging.

  • Page 19: Maintenance And Repairs

    17 Maintenance and repairs General Check the remOVE DC Impulse and its accessory components for damage or defects after every use. In particular, ensure that the insulation is intact on all cables. Do not use a damaged device or accessories. Immediately replace defective accessories.

  • Page 20: Disposal

    - All the instructions relating to installation and proper use, in accordance with these instructions for use, have been strictly followed. - Modifications, repairs, etc. have been carried out only by individuals authorised by Ovesco to perform these tasks. - The electrical installation in the room concerned complies with the local regulations and legal provisions.
  • Page 21 If the device overheats: All LEDs on the status display flash orange. Fault message All LEDs on the status display flash orange. Documentation Recording and storage of number of uses Yes, can only be accessed by service personnel 21 / 32 Ovesco; remOVE DC Impulse; English; Revision 9; 26.02.2020...

  • Page 22: Electromagnetic Compatibility (Emc)

    Ensure that no electronic devices that may be affected by electromagnetic fields are located in the vicinity of the remOVE DC Impulse. Any electromagnetic interference can lead to malfunctions and/or failure of the corresponding device and may therefore endanger users or patients.
  • Page 23 Guidelines and manufacturer’s declaration: Electromagnetic emitted interference The remOVE DC Impulse is designed for use in an electromagnetic environment as specified below. The user must ensure that the device is operated in such an environment. Measurement of emitted interference Conformity...
  • Page 24 Guidelines and manufacturer’s declaration: Electromagnetic immunity The remOVE DC Impulse is designed for use in an electromagnetic environment as specified below. The user must ensure that the device is used in such an environment. Immunity test IEC 60601-1-2: 2014-02 Compliance level...

  • Page 25: Guarantee

    22 Guarantee As the manufacturer, Ovesco Endoscopy AG provides a guarantee against defects in the materials and workmanship of the remOVE DC Impulse lasting 24 months from delivery. In the event of malfunctions caused by defective materials or incorrect assembly on the part of the manufacturer, the manufacturer will remedy the indicated defect at no charge within the guarantee period.

  • Page 26: Explanation Of The Symbols On The Packaging

    Do not use if packaging is damaged Atmospheric pressure limitation Humidity limitation Temperature limitation Number of items per package Labelling of electrical and electronic equipment in accordance with Directive 2012/19/EC (WEEE), see “Disposal” 26 / 32 Ovesco; remOVE DC Impulse; English; Revision 9; 26.02.2020...

  • Page 27: Appendix 1: Tsc Inspection Protocol

    24 Appendix 1: TSC inspection protocol The inspection protocol is available for download from the manufacturer’s website (www.ovesco.com). Ensure that the DC cable is connected to the generator. Do not press the foot-activated switch under any circumstances during the inspections.
  • Page 28 The manufacturer must be contacted in the event that discrepancies, anomalies and/or a fault message are present. The next periodic inspection must take place after 12 months. Name of the assessor Date / signature 28 / 32 Ovesco; remOVE DC Impulse; English; Revision 9; 26.02.2020...
  • Page 32 Ovesco Endoscopy AG Friedrich-Miescher-Straße 9 72076 Tübingen Germany Tel.: +49 (0)7071-96528-160 Fax: +49 (0)7071-96528-260 E-mail: service@ovesco.com Website: www.ovesco.com...

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