Set-Up Simplified
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MyoSure Clinical In-Service Set-Up Simplified
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