VERSAPOINT In Service Guide

Agenda • Introduction • Operative Hysteroscopy Overview • Assembly & Steps for Use • Demonstration Videos • Q&A • Enhanced Support Options

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Operative Hysteroscopy and GYNECARE VERSAPOINT™ Bipolar Electrosurgery System

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What is Operative Hysteroscopy? • Minimally invasive gynecological procedure • Operative Hysteroscope (or resectoscope) is inserted through the cervix into the uterine cavity

• Endoscopic surgical instruments are used to remove pathology • Allows surgeons to “see and treat” in a single outpatient intervention

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GYNECARE VERSAPOINT™ Bipolar Electrosurgery System • An electrosurgical system used in conjunction with continuous flow hysteroscopes for correction of the following pathologies1 – Myomas – Polyps – Intrauterine Adhesions – Uterine Septa

1. GYNECARE VERSAPOINT System Instructions for Use

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GYNECARE VERSAPOINT™ Bipolar Electrosurgery System • Operates in normal saline • Offers a range of electrode configurations similar to monopoloar for controlled, predictable tissue effects • Offers laser-like vaporizing and needle-like cutting, as well as desiccation • Provides excellent hemostasis with little or no charring • Current does not pass through the patient’s body

GYNECARE VERSAPOINT System enables surgeons to diagnose and treat various benign uterine pathologies with a single intervention1

1. GYNECARE VERSAPOINT System Instructions for Use

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GYNECARE VERSAPOINT™ Bipolar Electrosurgery System Components GYNECARE VERSAPOINT System Bipolar Generator

Footswitch (Yellow-vaporize/cut) (Blue-coagulate)

On/Off Switch

Connector Cable Socket

Alphanumeric User Display

User Buttons

Fault Indicator

Connector Cable (Approx 3m long)

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GYNECARE VERSAPOINT™ Bipolar Electrosurgery System Components Light Post Locking Collar

Outflow

Electrode Mounting Release Block Button

GYNECARE 30º WA Hysteroscope

Outer Sheath

Inner Sheath Resectoscopic Electrode

Distal Clip

“Return” “Active”

Shaft Seal

Inflow

Swivel Thumb Ring

Electrode Cable Boss Cord

“Active” 0º Vaporizing Electrode

“Return” Bipolar Loop Electrode Standard obturator not pictured

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Resectoscope Components

Hysteroscope (12º or 30º)

Working Element Outer Sheath

Hysteroscopic Bridge

Obturator

Inner Sheath

Resectoscope (Without Electrode)

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Electrodes After diagnostic observations, appropriate electrode can be chosen based on findings.

Spring Electrode

Ball Electrode

Twizzle Electrode

For rapid tissue vaporization and desiccation

For precise tissue vaporization and desiccation

For vaporization and needle-like cutting

0º Vaporizing Resectoscopic Electrode For raid tissue vaporization including endometrial ablation

Bipolar Loop Electrode For cutting and resection of tissue

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Assembly & Steps for Use

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Assembly & Steps for Use

Light Post Locking Collar

GYNECARE 30º WA Hysteroscope

1. Attach the hysteroscope to the working element. • Rotate the hysteroscope-locking collar counter clockwise until the indicator marks are aligned at the top

Working Element

• Insert the hysteroscope into the working element with the light post up • Lock the hysteroscope in place by rotating the locking collar clockwise until secure

Hysteroscope (12º or 30º)

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2. Attach the electrode to the working element. • Mount the electrode cable boss into the working element mounting block

Electrode Mounting Block

• Swing the electrode towards the hysteroscope • Position the shaft seal so that it fits into the seal groove on the working element and is flush with the sealing tape Note: The shaft seal is dropped into place, not slid

• Using gentle pressure, press the electrode hysteroscope clip onto the hysteroscope • Connect the electrode to the connector cable by aligning the alignment mark on the keyed connector with the alignment mark on the connector cable electrode connector and press firmly together until the electrode connector snaps into place

Distal Clip

Resectoscopic Electrode Electrode Cable Boss Shaft Seal

Standard obturator not pictured

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3. Attach the standard obturator to the inner sheath. • Insert the standard obturator into the sheath • Lock the standard obturator in place by pressing it firmly into the sheathlocking ring until the obturator snaps into place

4. Attach the assembled standard obturator and inner sheath to the outer sheath

Inner Sheath

Outer Sheath

Obturator

• Insert the assembled standard obturator and inner sheath assembly into the outer sheath • Screw the inner sheath into the outer sheath using the ribbed ring on the outer sheath

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5. Attach the light cable from the light source to the hysteroscope light post.

6. Attach the video endoscopy system camera head to the hysteroscope eyepiece (optional) 7. Attach the inflow tubing to the inflow valve on the inner sheath. An appropriate Luer lock adapter must be used with the inflow tubing set

GYNECARE 30º WA Hysteroscope Light Post

Outer Sheath

Inner Sheath

Outflow

Inflow

8. Attach the outflow tubing to the outflow value on the outer sheath. An appropriate Luer lock adapter must be used with the outflow tubing set Standard obturator not pictured

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Release Button

9. Insert the assembled standard obturator and sheaths into the uterus. • Dilate the cervix using an appropriate cervical dilator if necessary • Insert the assembled standard obturator and sheaths into the uterus through the cervix • Remove the standard obturator from the sheath by depressing the inner sheath-locking ring release button and withdrawing the obturator

Inner Sheath

Outer Sheath

Obturator

Standard obturator not pictured

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10. Attach the assembled working element, hysteroscope, and electrode assembly to the sheaths.

GYNECARE 30º WA Hysteroscope

• Fully retract the working element • Insert the working element, hysteroscope and electrode assembly into the sheaths • Lock the working element, hysteroscope and electrode assembly into place by pressing it firmly against the sheath-locking ring until it snaps into place

Resectoscopic Electrode

Note: To disassemble the electrode elements, simply pull them apart.

Standard obturator not pictured 17

Error Codes Problem: Generator resets during activation (Fault 100.10) Suggestions/Solutions: Check grounding of generator. Check insulation of connector cable. Check integrity of electrode. Ensure no contact was made with other equipment during activation. Problem: Unable to activate the generator Suggestions/Solutions: If your generator version supports both footswitch and possible future handswitchable accessories, check that the correct activation source is selected. Check footswitch for damage. Ensure approved footswitch is attached. Problem: No display on the generator Suggestions/Solutions: Check inlet fuse and replace with the correct type if necessary. Request assistance from qualified service engineer if fault persists. Problem: Generator flashes “Connect Cable” after cable inserted Suggestions/Solutions: Verify that the cable connector is fully inserted. Check for damage to cable flex. Remove connector and inspect pins for damage. Ensure only GYNECARE VERSAPOINT System approved accessories are being used.

Problem: Generator flashes “Insert Electrode” after electrode inserted Suggestions/Solutions: Ensure the connector contacts are clean and dry and have not been damaged during reprocessing. Check electrode integrity. Ensure only GYNECARE VERSAPOINT System approved accessories are being used. Problem: Generator overheats (Fault 300.10) Suggestions/Solutions: Allow generator to cool down before re-use. Check sufficient ventilation provided around generator. Ensure ambient temperature is within operating limits.

Problem: Error 200 Ref 15 Suggestions/Solutions: Hand piece is wet, or electrode has touched hysteroscope during activation. Stop activation. Disconnect hand piece. Initialize generator. Once display reads “Connect Cable,” connect hand piece to generator.

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Demonstration Videos

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http://www.ethicon.com/healthcareprofessionals/products/uterine-pelvic/operativehysteroscopy/gynecare-versapoint-bipolarelectrosurgery-system#!videos