MysoSure Hysteroscope Reprocessing Guide

GENERAL hysteroscope CLEANING

1

Disassembly:

Cleaning:

Soaking and Rinsing:

• Remove light post adapters

• Scrub all crevices using a cleaning brush to remove any visible debris (do not scratch any optical surface)

• Soak hysteroscope and accessories in an enzymatic, neutral pH cleaner for 5 minutes

• Scrub each lumen and flush with an enzymatic, neutral pH cleaner a minimum of 3 times to ensure no air remains within the lumen

• Thoroughly rinse the scope and accessory components to completely remove the cleaning solution

• Remove single-use seals from hysteroscope and outflow channel • Open stopcocks on hysteroscope and removable outflow channel

Please refer to the MyoSure Rod Lens Hysteroscope Instructions for Use for complete cleaning instructions.

General Hysteroscope Cleaning

Proper cleaning should be performed prior to sterilization

2

Maintenance • Always check the distal and proximal lenses of the hysteroscope for cracked or scratched lenses • Check the surface cleanliness of the distal and proximal lenses – A foggy or cloudy image can be the result of moisture entering the optical system or lack of cleanliness of exterior surfaces Polishing of Optical Surfaces – polishing should only be performed when the image as viewed through the scope is cloudy, and not as part of your routine cleaning procedures.

• The distal tip • The proximal window

or eyepiece • The fiber optic light post

Maintenance

Deposits may develop on the three optical surfaces as shown to the left. These include:

What Causes Build-Up? When proper cleaning and rinsing are not performed prior to sterilization, a build-up of deposits can form on the surfaces of the scope.

Deposits coat the rod lens and light fibers of scope

Light fibers are no longer coated with deposits

2

Glass has returned to a clear surface

Please refer to the following steps to ensure scope is producing the best possible image: Polishing of distal tip, eyepiece and fiber optic light post: 1. Dab some polishing paste onto a clean cotton swab and apply to optical surface in a light circular motion.

3. When surface is clean, take another cotton swab and remove any leftover polishing paste. If you have acetone or alcohol, use to clean off any extra polishing paste. 4. Check surfaces with an eye loupe to see if all deposits are removed and/or look through the scope to confirm clear image. Please refer to the MyoSure Rod Lens Hysteroscope Instructions for Use for complete cleaning instructions.

Maintenance

2. Take a clean cotton swab and use a little more force to clean any deposits on the optical surface.

STERILIZATION

3

Sterilization of hysteroscope and outflow channel isachieved with the following validated systems: Ethylene Oxide (100% EtO – wrapped)

Sterrad®

Follow standard hospital procedure maintaining the following parameters:

• Devices meet guidelines for Sterrad 100S, NX, and 100NX systems and require the use of a Sterrad-compatible tray or container system. Refer to manufacturer’s Instructions for Use for more information.

• Temperature: 131° ±5°F (55°C) • Relative Humidity: 35-70% • Gas Concentration: ~736 mg/l • Exposure Time: 60 minutes • Aeration Time: 11 hours

Follow standard hospital procedures: • Pre-vacuum method: 270-275°F (132-135°C) for 3 minutes • Gravity method: 270-275°F (132-135°C) for 15 minutes Please refer to the MyoSure Rod Lens Hysteroscope Instructions for Use for complete cleaning instructions.

Sterilization

Steam Autoclave Wrapped

Service–Accessories The following are replacement/service parts for the MyoSure Rod Lens Hysteroscope and Removable Outflow Channel: REF

Description

40-201

Replacement MyoSure Outflow Channel

ASY-04996

Hysteroscope Light Source Adapters – 1 each: Wolf and Storz

40-902

MyoSure Single Use Seal Set – 10 per box

40-904

Hysteroscope and Outflow Channel End Cap – 1 each

40-905

Polishing Paste – 3 tubes per package

Please contact Hologic Technical Support if the MyoSure Hysteroscopic Tissue Removal System fails to operate as intended, or if product is to be returned to Hologic for any reason. Hologic Technical Support United States Hologic, Inc. 250 Campus Drive, Marlborough, MA 01752 USA Phone: 1.800.442.9892 (toll-free) or 1.508.263.2900 Fax: 1.508.229.2795 IPD-00061-001 Rev.001 (12/12) © 2012 Hologic Inc. All rights reserved. Specifications subject to change without notice. Hologic and MyoSure and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries. All other trademarks, registered trademarks, and product names are the property of their respective owners.