VERSAPOINT II Footswitch User Manual June 2010

ENGLISH

GYNECARE VERSAPOINT™ II Hysteroscopic System Footswitch Non-Sterile, Reusable

INSTRUCTIONS FOR USE Please read all information carefully, in particular the User Manual which is provided with the GYNECARE VERSAPOINT™ II Generator, prior to using the device. The various components of the GYNECARE VERSAPOINT™ Hysteroscopic Electrosurgical System are designed to be used together as a single unit. Failure to properly follow instructions may lead to electrical or thermal injury and result in improper functioning of the device. IMPORTANT: This package insert is designed to provide instructions for use of the GYNECARE VERSAPOINT™ II Footswitch for the GYNECARE VERSAPOINT™ System. It is not a reference to electrosurgical or hysteroscopic technique. IMPORTANT: Use only approved GYNECARE VERSAPOINT™ Electrodes, accessories, and hysteroscopes with the GYNECARE VERSAPOINT™ System.

INDICATIONS The GYNECARE VERSAPOINT™ II Footswitch connects to the GYNECARE VERSAPOINT™ II Generator to activate the electrosurgical system. IMPORTANT: The GYNECARE VERSAPOINT™ II Footswitch is compatible ONLY with the GYNECARE VERSAPOINT™ II Generator.

INSTRUCTIONS FOR USE Read all instructions carefully. Failure to properly follow instructions may lead to electrical or thermal injury and cause improper functioning of the device, resulting in serious patient or user injury. Before starting any surgical procedure, the physician should be familiar with the medical literature, complications, and hazards of hysteroscopic electrosurgery in that procedure. Please refer to the GYNECARE VERSAPOINT™ II User Manual for step-by-step instructions regarding the assembly and initial system check of the GYNECARE VERSAPOINT™ System. Connecting the Footswitch The connection for the Footswitch is located on the front panel of the Generator. Align the red markers on both the Footswitch plug and the Generator Footswitch socket prior to insertion. Disconnecting the Footswitch To disconnect, pull the Footswitch connector body. Do not pull the cable. Pulling the cable may cause damage to the device. WARNING: Disconnect by pulling on the plug body. Do not pull on the cable. Pulling on the cable may cause damage to the device. Cleaning the GYNECARE VERSAPOINT™ II Footswitch WARNING: The Footswitch is not designed to be sterilized. Sterilization could lead to damage and/or malfunction of the device. 2

1. Remove all gross matter (blood, mucus, tissue) by wiping each component with a cloth or gauze pad and a mild cleaning solution or blood-dissolving detergent. Refer to cleaning product manufacturer for further information. IMPORTANT: Do not immerse in reprocessing solutions. Do not use abrasive cleaning agents. Do not use ultrasonic cleaners. Product damage may otherwise result. 2. Allow accessory devices to drain thoroughly. 3. Remove residual cleansing agents with a water-dampened cloth.

WARNINGS AND PRECAUTIONS Refer to all Warnings and Precautions in the GYNECARE VERSAPOINT™ II User Manual and in the Connector Cable and Electrodes Instructions for Use. CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician. To report any device-related incidents or problems, please contact (800) 255-2500 (US domestic only) or the Authorized European Representative.

SYMBOLS USED ON LABELING Batch number

Keep away from heat

Authorized Representative

Temperature limitations

See Instructions for Use

Catalogue number

Manufacturer

Fragile - handle with care

Keep dry

CE Mark and Identification Number of Notified Body. The product meets the essential requirements of the Medical Device Directive 93/42/EEC.

Electrical and electronic equipment. Return waste to a collection system or treatment and recycling facilities. Applicable in the EU. Follow decontamination instructions before returning waste.

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Gyrus Medical Limited Fortran Road St. Mellons Cardiff CF3 OLT United Kingdom Tel: +44 (0) 29 20776300 Fax: +44 (0) 29 20776301 Distributor • Distributør • Distributeur • Jälleenmyyjä • Distributeur • Vertriebshändler • Distributore • Distributør • Distribuidor • Distribuidor • Distributör • Διανομέας: CH Johnson & Johnson AG Rotzenbuehlstrasse 55 8957 Spreitenbach Switzerland

ETHICON Women’s Health & Urology A Division of ETHICON, INC. Somerville, New Jersey 08876-0151 USA © Ethicon, Inc. 2010

197007-A

2D Datamatrix scan:

IFU PRINTING SPECIFICATION SHEET

FOLD PATTERN

PAGE LAYOUT

6" (152.4 mm)

6" (152.4 mm)

Binding Method: Saddle Stitch

8" (203.2 mm)

4" (101.6 mm)

Flat Size

Folded Size

TITLE

DESCRIPTION

LAB NUMBER

SPECIAL INSTRUCTIONS/COMMENTS

COLORS

Versapoint II Footswitch

MAIN IFU

LAB0013985.1

n/a

Black

FLAT SIZE

FOLDED SIZE

RMC NUMBER

PAGE COUNT

BINDING

8" x 6" 203.2 mm x 152.4 mm

4" x 6" 101.6 mm x 152.4 mm

197007-A

28

Saddle Stitch

BLEED SIZE .5" (12.7 mm) .125" (3.175 mm)

NONE

X

STOCK 60 gsm bond

BLEED ALL SIDES

BLEED TOP BLEED RIGHT BLEED LEFT BLEED BOTTOM

SELF COVER

PLUS COVER

SEALING METHOD

X

DRAWING IS NOT TO SCALE: DRAWINGS REFLECT INFORMATION FOR PRODUCTION OF PRINTED PIECES AND DO NOT CONTAIN ACTUAL ARTWORK. This document or data herein or herewith is not to be reproduced, used or disclosed in whole or part without the permission of Ethicon, Inc.

WAFER SEAL