MyoSure Hysteroscope System Set-Up Simplified Rev 001

Illustrative Overview of MyoSure Procedural Connections

Saline

Saline

Regulated Vacuum Source

Scope Light Source

Camera Fluid Pump MyoSure Tissue Removal Device

Collection Canisters

MyoSure® Control Unit

MyoSure Foot Pedal

Myosure Procedure Requirements

1

MyoSure® Operative Hysteroscope, outflow channel, two single-use scope seals, and light source adaptor.

6

Outflow Y-tubing.

2

1 MyoSure Control Unit and foot pedal.

7

2-3 three liter collection canisters and tandem tubing.

3

1 MyoSure Tissue Removal Device.

8

2-3 three liter bags (.9%) sterile saline.

4

Camera, light cable, and video monitor.

9

1 tissue trap.

5

Hysteroscopic fluid pump with pump inflow tubing.

10

Regulated vacuum source and tubing.

11

1 under buttock drape with drainage port.

Myosure Procedure Requirements

Pump, Vacuum, Canister Assembly

STEP 1

1

Connect first collection canister to vacuum source.*

2

CANISTER CONFIGURATION(S) Vacuum Source

Tandem connect first canister to next canister (s) as referenced in the canister configuration diagram. Place tissue trap into last canister.

3

Set vacuum level per Fluid Pump Settings chart below.

4

Test vacuum level by placing finger over tissue trap opening to ensure all canisters are sealed.

Connection Port

Tissue Trap

VACUUM TEST

Tandem Connections

* Note: Depending on the size of the pathology being removed and the amount of saline used during diagnostic hysteroscopy and the procedure, three or more collection canisters and bags of saline may be required. The vacuum source connection should always be connected to the first canister in the chain. The last canister should be used to make patient connections such as the buttock drape and MyoSure Tissue Removal Device.

Fluid Pump Settings Pressure Setting minimum (mmHg)

Flow Rate (ml/min)

Vacuum Setting (mmHg) (Primary Source)

100

NA

275-300

Storz Endomat

80

500

350-400 (0.5 bar)

Olympus, Wolf, Stryker

80

500

400

Smith & Nephew

80

700

400

DOLPHIN II®

100

NA

300-400

Fluid Distention Device Brand/Model Vacuum Source

Davol HyDroFlex® HD Check Vacuum Prior to Use

Y-Tube Connection Port

Tissue Trap

5 Tandem Connections

Hang 2-3 three liter bags of sterile saline.*

®

Note: To maintain distention or improve visualization, pump fluid pressure should be set between 75-100mmHg. Refer to: Hysteroscopic Fluid Monitoring Guidelines, AAGL AdHoc Committee; F. Loffer M.D., L. Bradley M.D., A Brill M.D., P. Brooks M.D., and J. Cooper M.D. February 2000, Vol. 7 No. 1, The Journal of the American Association of Gynecological Laparoscopists.

TANDEM CONNECTIONS

MyoSure Hysteroscope Assembly

STEP 2

1

Connect light source and camera to MyoSure® Hysteroscope.* SALINE

2

SALINE

Attach pump tubing to pump and spike bags. SCOPE

REGULATED VACUUM

3

Connect inflow tubing to hysteroscope inflow port.*

4

Prime pump and Hysteroscope into a separate basin.

LIGHT SOURCE CAMERA

FLUID PUMP

COLLECTION CANISTERS

* Note: Sterile connection

MyoSure Hysteroscope Assembly

Outflow Assembly

STEP 3

1

2

Connect outflow Y-tubing by attaching one short Y-tube end with clamp to the under buttock drape and the other short Y-tube end to the MyoSure® outflow channel.* Connect long Y-tube end to the patient port of the last collection canister.

Vacuum Outflow Configuration

3

Reduce vacuum to buttock drape by clamping off tube as illustrated and instructed in RED below. (This is essential in order to maximize optimal performance of the MyoSure Tissue Removal Device while in use.) * Note: Outflow channel for use during diagnostic phase only.

Gravity Outflow Configuration

Vacuum Source

Vacuum Source Removable Outflow Channel

Removable Outflow Channel Scope

Scope Yellow

Yellow

Tubing from Vacuum Source “Y” Tubing Set

Outflow Clamp (Reduce vacuum by depressing clamp down 3 “clicks”)

Drape Tubing

Drape Tubing

MyoSure Tissue Removal Device and Control Unit Assembly

STEP 4

Regulated Vacuum Source

1

Connect foot pedal to MyoSure® Control Unit (for reuse, place in protective cover).

2

Connect MyoSure Tissue Removal Device tubing to tissue trap.*

3

Connect MyoSure Tissue Removal Device drive cable to MyoSure Control Unit.

MyoSure Tissue Removal Device

MyoSure Drive Cable

Tandem Connection

MyoSure Control Unit

* Note: open MyoSure device sterile package upon hysteroscopic confirmation of intrauterine pathology. Tissue Trap

* Note: All unused ports MUST be sealed to achieve required vacuum MyoSure Foot Petal

MyoSure Setup Guide

Troubleshooting Tips

The following tips will help you manage poor uterine distention and/or poor field of view intra-operatively.

Fluid Management System 1

Verify saline bag clamp is open.

2

Verify that all canister lids are sealed.

3

4

Under buttock drape 1

Check buttock drape clamp to ensure it is not wide open. Clamp off.

MyoSure Tissue Removal Device 1

Hysteroscope 1

Ensure inflow tubing is on the inflow port.

2

Ensure inflow tubing is not occluded or pinched.

3

Lower suction/vacuum level.

Increase fluid pump pressure*.

Increase fluid pump flow rate.

* For further guidance refer to: Hysteroscopic Fluid Monitoring Guidelines, AAGL AdHoc Committee; F. Loffer M.D., L. Bradley M.D., A. Brill M.D., P. Brooks M.D., and J. Cooper M.D. February 2000, Vol. 7. No. 1, The Journal of the American Association of Gynecological Laparoscopists

Troubleshooting Tips

Retract MyoSure® Tissue Removal Device with leading edge of cutting window visible and depress foot pedal for 1-2 seconds to clear field.

Ordering Information

Description

Order Number

MyoSure® Hysteroscopic Tissue Removal System Control Unit Includes: power foot pedal and users manual

10-500

MyoSure Hysteroscopic Tissue Removal Device – (Minimum order of 3)

10-401

MyoSure Rod Lens Hysteroscope

40-200

MyoSure Rod Lens Hysteroscope Outflow Channel

40-201

Single-use Seal Set, Hysteroscope and Outflow Channel – Box 10

40-902

MyoSure Hysteroscopic Tissue Removal System Control Unit Replacement Foot Pedal

10-903

MyoSure Hysteroscopic Tissue Removal System Control Unit Replacement Power Cord

10-900

Specimen Collection Options

For reference only. Hologic does not distribute this accessory.

For Use With Canister Manufacturer/Brand

Part Number

Bemis® Healthcare™ Hi-Flow™ Rigid Canisters

533810

Cardinal Health Medi-Vac® Collection Canisters

(3000cc) 65652-122 (2000cc) 65652-123

DeRoyal®

71-1123

Ordering Information

United States / Latin America 135 Newbury Street Framingham, MA 01701 Tel: 877.222.8508 Fax: 877.832.7564 www.hologic.com

© 2011 Hologic, Inc. All rights reserved. Printed in the United States. Specifications are subject to change without prior notice. Trademarks are the property of their respective owners

MISC-01567-001 Rev. 001