medtronic
Heart Valve Accessories Tray
Heart Valves Contour 3D Accessory Tray Instructions for Use Rev 1A
134 Pages
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Heart Valves/Annuloplasty 1. Device description Accessory trays are provided in the following configurations: ■ T7630 - CG Future™ accessory tray ■ T7660 - Duran AnCore™ accessory tray ■ T7625 - Freestyle™ accessory tray ■ T7610 - Hancock™ II aortic accessory tray ■ T7605 - Hancock™ II mitral accessory tray ■ T7308C - Mosaic™ aortic accessory tray ■ T7615 - Mosaic™ mitral accessory tray ■ T7308U - Mosaic Ultra™ accessory tray ■ T7505UX - Hancock II Ultra™ Supra-X™ accessory tray ■ T7680 - Profile 3D™ accessory tray ■ T7690 - Contour 3D™ accessory tray ■ T7400 - Avalus™ accessory tray Accessory trays are used for the storage of the various accessories when the accessories are not in use. The tray can also be used to hold the accessories during sterilization. The tray does not provide a sterile barrier. It must be placed in a sterilization pouch or autoclavable drape before sterilization.
2. Indications for use Accessory trays are used for storing accessories. The trays also can be used to hold the accessories during sterilization.
3. Contraindications None known.
4. Precautions ■ ■ ■
Do not use solvent-based cleaners (for example, acetone or toluene) when cleaning the accessory trays. Use water-soluble surfactant-type soaps or mild detergents as cleaning agents. Carefully inspect each tray before use for cracks or flaws that may result from sterilization, handling, or general use. Do not use any accessory tray that shows excessive signs of wear.
5. Instructions for use The accessory tray allows for storing each accessory after use. Numeric labels on the tray match the labels on each sizer. The cavities in the tray reflect the shape of the accessory. Refer to the figures for illustrations of how to package the accessories in the trays.
6. How supplied ■ ■
The accessory tray includes a storage tray and lid. Instructions for use are included with each tray.
6.1. Packaging The accessory tray is supplied nonsterile in a shelf carton. The accessories and the tray must be placed in a sterilization pouch or autoclavable drape before sterilization. 6.2. Storage For maximum protection and product identification, store the accessories in the accessory tray. The storage environment should be clean, cool, and dry.
7. Processing and reprocessing The following instructions have been validated by Medtronic for preparing this medical device for reuse. It remains the responsibility of the processor to ensure that the processing, as actually performed using equipment, materials, and personnel in the processing facility, achieves the desired result. This requires validation and routine monitoring of the process. Likewise, any deviation by the processor from the following instructions should be properly evaluated for effectiveness and potential adverse consequences. Warning: Do not use acetone-based cleaners.
Instructions for Use
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7.1. Cleaning Warning: Thoroughly clean the device to eliminate soil before sterilization. ■ Do not allow contaminated devices to dry before implementing any cleaning procedure. ■ It is recommended that devices are reprocessed as soon as reasonably practical following use. ■ If the device contains multiple components, completely disassemble the components before cleaning per these Instructions for Use. ■ Examine the components for cracking or degradation before use. Do not use if components show signs of cracking or degradation. ■ Thermal disinfection is not required since devices are terminally sterilized. 7.1.1. Manual cleaning Medtronic has established the following manual cleaning procedure: 1. Submerge the devices in an enzymatic detergent (for example, ENZOL™) diluted with warm tap water 22°C to 43°C (72°F to 110°F) according to the manufacturer’s recommendations for a minimum of 5 minutes. 2. Remove visible soil with a soft-bristled brush (for example, nylon toothbrush). 3. Rinse the devices with warm running tap water 22°C to 43°C (72°F to 110°F) for a minimum of 1 minute. 4. Dry with a clean, lint-free wipe. 5. Visually inspect each component for any remaining soil or moisture. If soil remains, repeat the cleaning process. If wet, use a lint-free wipe to dry. 7.1.2. Automated cleaning Point of use (within a maximum of 2 hours) 1. Remove gross soil from the devices by rinsing under cold running tap water. 2. Soak the devices in an enzymatic detergent (for example, ENZOL) as prepared by the detergent manufacturer’s instructions, for a minimum of 1 minute. 3. Use a soft bristle brush (for example, nylon toothbrush) to clean the devices thoroughly, if needed. 4. Rinse the devices with warm tap water 22°C to 43°C (72°F to 110°F) for a minimum of 2 minutes. 5. Visually inspect the device for any remaining soil. Repeat the above steps, if needed. 6. Transport the devices to the processing area. Note: If transfer is likely to be delayed, place the devices in a covered container with an enzymatic detergent (for example, ENZOL) to prevent drying. Pretreatment (for heavily soiled devices) 1. Immerse the devices in a covered container with an enzymatic detergent (for example, ENZOL) using warm tap water 22°C to 43°C (72°F to 110°F). 2. Clean each component thoroughly using a soft bristle brush (for example, nylon toothbrush). Note: Take care to clean areas where soil may be impacted or shielded from the cleaning process. 3. Rinse the devices in warm running tap water 22°C to 43°C (72°F to 110°F) for a minimum of 2 minutes or until all traces of the cleaning solution are removed. 4. Visually inspect the devices for any remaining soil. 5. Repeat the above steps, if needed. 6. Allow the devices to dry. Ultrasonic cleaning and rinsing (if needed) 1. Submerge the devices completely in an ultrasonic cleaner (for example, Bransonic™) with 29.57 mL (1 ounce) of an enzymatic detergent (for example, ENZOL) and 3.79 L (1 gallon) of warm tap water 22°C to 43°C (72°F to 110°F). Sonicate for 10 minutes. 2. Rinse each component with deionized water for a minimum of 3 minutes. Ensure the detergent has been removed from all holes and openings. 3. Inspect each component for evidence of soil for a minimum of 1 minute. 4. Repeat the above steps, if needed. 5. Allow the devices to dry.
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Instructions for Use
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Automatic washing Medtronic used the Prolystica™ family of cleaners according to the manufacturer’s recommendations to validate the automated cleaning process. It is the responsibility of the processor to ensure that the processing is conducted in accordance with a validated method. Any deviation by the processor from these recommendations should be evaluated. The cleaning method may be manual or automated per these Instructions for Use or an equivalent validated method. 1. Place the devices in an automated washer (for example, HAMO™ LS-1000 washer/disinfector). Avoid contact between devices while loading the washer. Treatment Enzymatic wash
Time (minutes) 04:00
Temperature >55°C (>131°F)
Water quality tap water
Wash
02:00
>45°C (>113°F)
tap water
Rinse Dry
02:00 15:00
>65°C (>149°F) >70°C (>158°F)
tap water not applicable
Cleaning agent Prolystica Ultra Concentrate Enzymatic Cleaner Prolystica Ultra Concentrate Neutral not applicable not applicable
2. Visually inspect each component for any remaining soil and moisture. If soil remains, repeat the process. 3. Dry the devices with filtered, compressed air or a lint-free wipe, if needed. 7.2. Sterilization and resterilization ■ ■ ■
A standard packaging material may be used. Ensure that the pack is large enough to contain the instrument without stressing the seals. The validation performed by Medtronic utilized the appropriate accessory tray for each device. When sterilizing multiple devices in 1 autoclave cycle, ensure that the sterilizer’s maximum load is not exceeded. Examine the devices for cracking or degradation before use. Do not use if components show signs of cracking or degradation.
7.2.1. Steam sterilization Table 1. Sterilization cycle parameters for the United States and its territories Cycle type Temperature Exposure time Dry time
Gravity displacement 132°C (270°F) 15 minutes 15 minutes
Prevacuum (dynamic-air-removal) 132°C (270°F) 135°C (275°F) 4 minutes 3 minutes 30 minutes 16 minutes
For medical facilities located outside the United States and its territories: Some non-U.S. health care authorities recommend sterilization with parameters that will minimize the potential risk of transmitting Creutzfeldt-Jakob Disease (CJD). This recommendation is especially important for surgical instruments that could come into contact with the central nervous system. Table 2. Sterilization cycle parameters for medical facilities outside the United States and its territories Cycle type
Gravity displacement
Temperature Exposure time Dry timeb
134°C (273°F) 20 minutes 30 minutes
Prevacuum (dynamic-airremoval) 134°C (273°F) 4 minutes 30 minutes
Prevacuum (dynamic-airremoval) for CJDa 134°C (273°F) 18 minutes 30 minutes
a Medtronic recommends incinerating devices that have directly contacted patients suspected or confirmed with Transmissible Spongiform Encephalopathy (TSE)/CJD diagnosis. NHS Estates HTM 2010 Parts 4
& 6: Appendix 2, Items contaminated with TSE Agents and WHO Infection Control Guidelines for Transmissible Spongiform Encephalopathies refer to a TSE decontamination cycle using a steam autoclave at a temperature of 134ºC to 137ºC (273ºF to 279ºF) for a single cycle of 18 minutes or multiple cycles totaling 18 minutes (for example, six 3-minute cycles). b The minimum dry times were validated using sterilizers with vacuum drying capabilities. Drying cycles using ambient atmospheric pressure may require longer dry times. Refer to the sterilizer manufacturer’s recommendations.
8. Disclaimer of warranty THE FOLLOWING DISCLAIMER OF WARRANTY APPLIES TO UNITED STATES CUSTOMERS ONLY: ALTHOUGH THE ACCESSORY TRAYS, HEART VALVES/ANNULOPLASTY, HEREAFTER REFERRED TO AS “PRODUCTS,” HAVE BEEN MANUFACTURED UNDER CAREFULLY CONTROLLED CONDITIONS, MEDTRONIC HAS NO CONTROL OVER THE CONDITIONS UNDER WHICH THESE PRODUCTS ARE USED. MEDTRONIC, THEREFORE, DISCLAIMS ALL WARRANTIES, BOTH EXPRESS AND IMPLIED, WITH RESPECT TO THE PRODUCTS, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. MEDTRONIC SHALL NOT BE LIABLE TO ANY PERSON OR ENTITY FOR ANY MEDICAL EXPENSES OR ANY DIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES CAUSED BY ANY USE, DEFECT, FAILURE, OR MALFUNCTION OF THE PRODUCTS, WHETHER A CLAIM FOR SUCH DAMAGES IS BASED UPON WARRANTY,
Instructions for Use
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CONTRACT, TORT, OR OTHERWISE. NO PERSON HAS ANY AUTHORITY TO BIND MEDTRONIC TO ANY REPRESENTATION OR WARRANTY WITH RESPECT TO THE PRODUCTS. The exclusions and limitations set out above are not intended to, and should not be construed so as to, contravene mandatory provisions of applicable law. If any part or term of this DISCLAIMER OF WARRANTY is held to be illegal, unenforceable, or in conflict with applicable law by a court of competent jurisdiction, the validity of the remaining portions of this DISCLAIMER OF WARRANTY shall not be affected, and all rights and obligations shall be construed and enforced as if this DISCLAIMER OF WARRANTY did not contain the particular part or term held to be invalid.
9. Disclaimer of warranty THE FOLLOWING DISCLAIMER OF WARRANTY APPLIES TO CUSTOMERS OUTSIDE THE UNITED STATES: ALTHOUGH THE ACCESSORY TRAYS, HEART VALVES/ANNULOPLASTY, HEREAFTER REFERRED TO AS “PRODUCTS,” HAVE BEEN CAREFULLY DESIGNED, MANUFACTURED, AND TESTED PRIOR TO SALE, THE PRODUCTS MAY FAIL TO PERFORM THEIR INTENDED FUNCTION SATISFACTORILY FOR A VARIETY OF REASONS. THE WARNINGS CONTAINED IN THE PRODUCT LABELING PROVIDE MORE DETAILED INFORMATION AND ARE CONSIDERED AN INTEGRAL PART OF THIS DISCLAIMER OF WARRANTY. MEDTRONIC, THEREFORE, DISCLAIMS ALL WARRANTIES, BOTH EXPRESS AND IMPLIED, WITH RESPECT TO THE PRODUCTS. MEDTRONIC SHALL NOT BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES CAUSED BY ANY USE, DEFECT, OR FAILURE OF THE PRODUCTS, WHETHER THE CLAIM IS BASED ON WARRANTY, CONTRACT, TORT, OR OTHERWISE. The exclusions and limitations set out above are not intended to, and should not be construed so as to, contravene mandatory provisions of applicable law. If any part or term of this DISCLAIMER OF WARRANTY is held by any court of competent jurisdiction to be illegal, unenforceable, or in conflict with applicable law, the validity of the remaining portion of the DISCLAIMER OF WARRANTY shall not be affected, and all rights and obligations shall be construed and enforced as if this DISCLAIMER OF WARRANTY did not contain the particular part or term held to be invalid.
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Instructions for Use
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Americas
Europe/Africa/Middle East Headquarters Medtronic International Trading Sàrl Route du Molliau 31 Case Postale 84 CH - 1131 Tolochenaz Switzerland Internet: www.medtronic.co.uk Tel. +41 21 802 7000 Fax +41 21 802 7900
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Authorized Representative in the European Community Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel. +31 45 566 8000 Fax +31 45 566 8668
Asia-Pacific Australia Medtronic Australasia Pty. Ltd. 97 Waterloo Road North Ryde NSW 2113 Australia Tel. +61 2 9857 9000 Fax +61 2 9878 5100 Asia Medtronic International Ltd. 49 Changi South Avenue 2 Singapore 486056 Tel. +65 6436 5000 Fax +65 6776 6355
United States Manufacturer: Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 USA Internet: www.medtronic.com Tel. +1 763 526 7890 Fax +1 763 526 7888 Toll-free: +1 877 526 7890 (24-hour consultation service) Manufactured in Medtronic Heart Valves Division 1851 E. Deere Avenue Santa Ana, CA 92705 USA
© 2005, 2007, 2010, 2013, 2016 Medtronic M059236T001 Rev. 1A *M059236T001*