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ENGLISH
Instrument Tray Instructions for Use Indications for Use/Intended Use
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The MyoSure® Instrument Tray is intended to enclose, protect, and organize the MyoSure® Rod Lens Hysteroscope, MyoSure® Removable Outflow Channel, and associated components, during sterilization and storage.
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Hologic recommends the use of a mild enzymatic detergent with a near neutral pH. Do not use solvents, abrasive cleaners, metal brushes, or abrasive pads. Trays may be placed in mechanical cleaning equipment
The MyoSure® Instrument Tray must be used in conjunction with a sterilization wrap that is cleared by FDA for the indicated sterilization cycle, and may be stored for up to 30 days in accordance with the wrap manufacturer’s instructions.
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The MyoSure® Instrument Tray has been validated for the following sterilization cycles:
CAUTION: Trays are reusable but may eventually be damaged. Always inspect tray components for cracking, chipping, or other signs of damage before use. Make sure all latches and handles are secure and in working order. Damaged trays should be removed from service. Minor Surface cosmetic changes may occur with long-term use or after Sterrad® processing.
Prevacuum Steam
Gravity Steam
STERRAD® 100S™
132°C (270°F)
132 °C (270 °F)
59% H2O2
4 minutes exposure
15 minutes exposure Normal Cycle Setting Normal Cycle Setting
30 minutes dry time
30 minutes dry time
Contents - 1 MyoSure® Rod Lens Hysteroscope, 1 Removable Outflow Channel, 2 Seal Caps, 2 Light Guides
Contents - 1 MyoSure® Rod Lens Hysteroscope, 1 Removable Outflow Channel, 2 Seal Caps, 2 Light Guides
CAUTION: Always inspect tray components for cleanliness and confirm that there is no visual contamination prior to use.
CAUTION: Only use accessory components that have been designed and tested for use in MyoSure® Instrument Trays.
Contents - 1 MyoSure® Rod Lens Hysteroscope, 1 Removable Outflow Channel, 2 Seal Caps, 2 Light Guides
Sterilization Recommendations Do not overload trays. Place and arrange tray contents in accordance with Figure 1 to facilitate sterilant contact with all objects in the tray.
Contraindications Stacking of trays and overloading of the units will adversely affect sterilization and drying effectiveness. DO NOT STACK trays in the sterilization chamber.
Care and Cleaning Recommendations • • • • • •
Pre-Rinse soiled trays in tap water for 2 minutes Both physical and chemical (enzymatic detergent) processes may be necessary to clean soiled items. Follow enzymatic detergent manufacturer’s instructions Chemical (enzymatic detergent) cleaners alone may not remove all soil and debris; therefore, a careful manual cleaning of each item with a soft sponge or cloth is essential. For difficult access areas, a clean, soft-bristled brush is recommended. Repeat cleaning steps if visible contamination of tray components is observed. Once the items have been cleaned, they should be thoroughly rinsed with clean water to remove any detergent or chemical residue before sterilization. 1
Figure 1
Process the tray according to the sterilization wrap manufacturer’s instructions prior to sterilization to maintain sterility of internal components/items and for proper aseptic presentation to the surgical field. Product may be maintianed for up to 30 days after sterilization in accordance withthe wrap manufacturer’s intructions.
Steam Sterilization Performance of the MyoSure® Instrument Tray has been verified in the following steam autoclave cycles for sterilization of the MyoSure® Rod Lens Hysteroscope and accessory components.
ENGLISH Table 1 - Steam Pre-Vacuum Sterilization Parameters
whenever handling a load after a cycle cancellation, or if any moisture is noted on a load following a completed cycle.
Temperature
270°F (132°C)
Exposure Time
4 minutes
Service – Accessories
Dry Time
30 minutes
Validated Device Load
≤ 5 lbs. (1 MyoSure® Rod Lens Hysteroscope 1 Removable Outflow Channel, 2 seal caps, 2 light guides)
Validated Sterilizer Load
Single tray in an otherwise empty sterilization chamber
Table 2 - Steam Gravity Displacement Sterilization Parameters
Temperature
270°F (132°C)
Exposure Time
15 minutes
Dry Time
30 minutes
Validated Device Load
≤ 5 lbs. (1 MyoSure® Rod Lens Hysteroscope 1 Removable Outflow Channel, 2 seal caps, 2 light guides))
Validated Sterilizer Load
Single tray in an otherwise empty sterilization chamber
Variables that may affect drying times include: loading density of the case/ tray, instrument configuration, total contents of the sterilizer, steam quality, equipment maintenance, and others. CAUTION: Do not load trays into sterilizer on sides or upside down with lid side on the shelf or cart. Load trays on cart or shelf, so that the lid is always facing upward. This will allow for proper drying. The MyoSure® Instrument Tray is designed to drain in this position. CAUTION: After the autoclave door is opened, all trays must be allowed to cool thoroughly. Place trays on a rack or shelf with linen cover until cooling is complete. The potential for condensation may increase if the tray is not allowed to cool properly. If condensation is observed, verify that the steam, which is being used for sterilization processing, has a quality of more than 97%. Also confirm that the sterilizers have been inspected for routine maintenance in accordance with manufacturer recommendations.
STERRAD® Sterilization
The following are replacement parts for the MyoSure® Instrument Tray: REF
Description
40-903
MyoSure® Instrument Tray
WARRANTY, SERVICE, AND REPAIR WARRANTY INFORMATION THE MYOSURE® INSTRUMENT TRAY AND ACCESSORIES ARE PROVIDED “AS IS” WITH NO WARRANTY, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. CUSTOMER IS RESPONSIBLE FOR ANY REPAIR OR REPLACEMENT OF THE MYOSURE® INSTRUMENT TRAY.
TECHNICAL SUPPORT AND PRODUCT RETURN INFORMATION Contact Hologic Technical Support if the MyoSure® Instrument Tray fails to operate as intended. Hologic Technical Support United States: Phone: 1.800.442.9892 (toll-free) or 1.508.263.2900 Fax: 1.508.229.2795
For Further Information If further information on this product is needed, please contact Hologic Customer Service at 800-442-9892 in the U.S., or your authorized representative. In USA contact: Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 Toll Free Phone: 1-800-442-9892 Toll Free Fax: 1-800-409-7591 Hologic, MyoSure, and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and other countries. All other trademarks, registered trademarks, and product names are the property of their respective owners.
The MyoSure® Instrument Tray has been validated for use with the STERRAD® 100S™ System. Table 3 - STERRAD® Sterilization Summary
Sterilizer Model #
STERRAD® 100S™
Sterilizer Cycle
STERRAD® 100S™ cycle
Validated Device Load
≤ 5 lbs. (1 MyoSure® Rod Lens Hysteroscope, 1 Removable Outflow Channel, 2 seal caps, 2 light guides))
Refer to the STERRAD® 100S™ User’s Guide for additional warnings, precautions, and more information about the STERRAD® 100S™ sterilization process.
The MyoSure instrument tray is manufactured for and distributed by:
WARNING: Hydrogen peroxide is corrosive and concentrated hydrogen peroxide is toxic. Wear chemical resistant latex, PVC (vinyl), or nitrile gloves
250 Campus Drive Marlborough, MA 01752 USA ©2013 Hologic, Inc. All Rights Reserved.
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MAN-02848-001 Rev. 002 02-2013