LeMaitre PhasTIPP 5001-01 Instructions For Use Manual
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LeMaitre PhasTIPP 5001-01 Instructions For Use Manual

Illuminator handpiece
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PhasTIPP™ Illuminator Handpiece
Instructions for Use - English

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Summary of Contents for LeMaitre PhasTIPP 5001-01

  • Page 1 PhasTIPP™ Illuminator Handpiece Instructions for Use - English...

  • Page 2: Table Of Contents

    (Model Number 5001-01) Instructions for Use - English Preface The LeMaitre Vascular PhasTIPP Illuminator consists of the non-sterile Illuminator Handpiece and the sterile Disposable Illuminator. This manual contains information you need to operate and maintain the PhasTIPP Illuminator Handpiece. It is essential that you read and understand all of the information in this manual before using or maintaining the system.

  • Page 3: Device Description

    It is classi ed as a continuous use de- vice, however, review the Warnings section for guidance on elevated temperatures prior to use (#15-18). The Illuminator Handpiece can be used with the LeMaitre Vascular PhasTIPP Resec- tor components for illumination in powered phlebectomy cases. PhasTIPP Illuminator Handpiece...
  • Page 4 1. When removing the Illuminator Handpiece from the shipping box, inspect contents to ensure that no damage is evident. Contact your LeMaitre Vascular representative if damage is noted. 2. Before using the Illuminator Handpiece for the rst time, you should review all available product information.

  • Page 5: Potential Complications

    1. U.S. Federal law restricts this device to sale by or on the order of a physician. 2. Only the LeMaitre Vascular PhasTIPP Disposable Illuminator can be used with the Illuminator Handpiece. The Disposable Illuminator is for single use only and must be disposed of after use.
  • Page 6 1. Illuminator Handpiece, Non-Sterile The Illuminator Handpiece is a hand held battery operated device that provides on / off button control for the operation of the intense white light output from the Disposable Illuminator. It also provides LED indicator lights to display the status of the device.

  • Page 7: Unpacking The Components

    LeMaitre Vascular representative. Save the box and packing materials in the event a component must be returned for repair. When not in use, the Illuminator Handpiece should be stored in a LeMaitre Vascular PhasTIPP Storage Case (REF 5000-01 or -02).

  • Page 8: Llluminator Control

    If the yellow low battery indicator light is on obtain new batteries from a new PhasTIPP Disposable Illuminator. If the red fault indicator light is on, contact LeMaitre Vascular for service (see “Repair Service Program” section). The non-sterile Illuminator Handpiece is designed to be isolated from the sterile...

  • Page 9: Postoperative Procedure

    Also available as an accessory is the Illuminator Injection Tubing (REF 5003- 01). The larger diameter tube at one end may be directly connected to the illuminator shaft and clamped in place (see gure). The male luer lock on the other end of the tubing can be connected to any needle for subdermal infusion via needle.

  • Page 10: Service

    Illuminator Handpiece will turn off . In some cases, the system will continue to operate normally, but in other cases the device will not function. If the procedures below do not resolve the problem, the unit should be returned to LeMaitre Vascular for service.

  • Page 11: Technical Speci Cations - Phastipp Illuminator Handpiece

    Illuminator. No light from Disposable The Illuminator • Return Illuminator Handpiece to Illuminator. Handpiece is LeMaitre Vascular for service or defective. replacement. • Remove batteries to cut power to device. The illuminator The Illuminator light output will Handpiece is •...

  • Page 12: Guidance And Manufacturer's Declaration - Electromagnetic Emissions

    Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The PhasTIPP Illuminator Handpiece is intended for use in the electromagnetic environment speci ed below. The customer or the user of the Illuminator Handpiece should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment -...

  • Page 14: Guidance For Separation Distances

    The sole remedy for a breach of this limited warranty shall be replacement of, or refund of the purchase price for, this device (at LeMaitre Vascular’ s sole option) following the purchaser’s return of the device to LeMaitre Vascular.

  • Page 15: Training Program

    A revision or issue date for these instructions is included on the back page of these Instructions for Use for the user’s information. If twenty-four (24) months has elapsed between this date and product use, the user should contact LeMaitre Vascular to see if additional product information is available.
  • Page 18 Tel: (781) 221-2266 Fax: (781) 221-2223 LeMaitre Vascular, Inc. 63 Second Avenue Burlington, MA 01803 LeMaitre is a registered trademark, and PhasTIPP is a trademark, of LeMaitre Vascular, Inc. ©2022 LeMaitre Vascular, Inc. All rights reserved. Printed in the USA.

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