Trifecta Sizer Set Instructions for Use

State: Released Date: 2019.06.25 15:06 GMT

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State: Released Date: 2019.06.25 15:06 GMT

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State: Released Date: 2019.06.25 15:06 GMT

EN: English Trifecta™ Sizer Set Instructions for Use

Description The Trifecta™ Sizer Set Model TF2000 is a multicomponent kit that facilitates the size selection of the Trifecta™ Valve. The sizer handles and the UT2000 Holder Handle can be bent in any direction up to a 90° angle without degradation. When the flexible handles are exposed to the heat produced during autoclave sterilization, they will revert to their original shape. Refer to the Instructions for Use packaged with each valve for detailed sizing and implantation instructions. The corresponding valve size is indicated on each sizer. The sizer set is reusable and must be cleaned and sterilized prior to each use.

Indications The sizer set is indicated for use with the devices listed in the Description section of this manual.

Contraindications The sizer set is contraindicated for use with any devices not listed in the Description section of this manual. Any sterilization method other than steam is contraindicated.

Components Each Sizer Set Model TF2000 includes:  Six (6) double-ended aortic sizers with a valve replica end and a cylindrical annular sizing end; odd sizes corresponding to valve sizes 19 mm – 29 mm  

One (1) valve Holder Handle Model UT2000 One (1) autoclavable tray with cover

Replacement components for this set, including the sizers and the valve holder handle, are sold separately. The tray provides storage for two optional accessories that can be ordered separately. When sterilizing replacement components, use the steam sterilization parameters indicated for the sizer set.

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Figure 1. TF2000 Sizer 1. Replica end 2. Cylindrical annular sizing end

Storage The non-sterile sizer set may be stored indefinitely.

Precautions Instruments must be cleaned and sterilized prior to each use. Do not use cracked, deformed, discolored/rusted, or damaged instruments. Improper cleaning may result in an immunological or toxic reaction. The sterilization temperature must not exceed 138°C (280°F). Do not bend flexible instrument handles beyond a 90° angle. Do not expose instruments to cleaning or rinse agents that are not compatible with polyphenylsulfone. Autoclavable sizer set trays do not provide a sterile barrier. Handle sizer sets in the same manner as other reusable instruments that require packaging or wrapping during autoclave sterilization.  All instruments must be sterilized in a tray or container that is permeable to steam.       

Directions for Use See the instructions for use packaged with the applicable implantable device for detailed sizing, handling, and implantation instructions. The sizer set has been designed and tested for repeated use. However, if visual signs of deterioration become apparent, please contact your customer service representative.

Reprocessing Requirements St. Jude Medical has validated these reprocessing instructions. If alternate methods are used, it is the user's responsibility to ensure that their methods provide effective cleaning and disinfection. The cleaning method must remove all visible blood soil and contamination.

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Testing indicates that products described herein may undergo 100 cleaning/disinfection cycles when cleaned using the specified reprocessing methods. Deviations from the specified methods may result in reduced instrument life or inadequate cleaning and disinfection. Reprocess instruments as soon as reasonably possible following use. After each reprocessing cycle inspect instruments for signs of cracking, crazing, or degradation that may affect function.

Reprocessing Option 1 Manual Cleaning and Disinfection Method The following manual cleaning and disinfection method was validated: 1.

Wipe the instrument with a wet, disposable sponge to remove gross soil.

2.

Rinse the instrument in hot, running tap water for a minimum of 20 seconds to remove visible blood soil.

3.

Soak the instrument in a bath of Terg-A-Zyme 1 Enzymatic Cleaner (Alconox) for five minutes.

4.

Items should be mechanically cleaned with appropriately sized non-abrasive brushes until visibly clean.

5.

Rinse instrument with hot de-ionized (DI) water for a minimum of 20 seconds to remove remaining soil and cleaning agent.

6.

Allow to air dry or dry the instrument with a clean, disposable, absorbent, non-shedding wipe.

Automated Cleaning, Washer-Disinfector Method The automated washer-disinfector method described below was validated. Testing was conducted using HAMO 2 LS1000 washer-disinfector with Renuzyme 3 enzyme detergent. Prior to placing the instruments in the washer-disinfector, remove visible blood soil using warm DI water and a brush. Secure instruments in the washer-disinfector and perform the following programmed cleaning cycle: Table 1. Automated Washer-Disinfector Cycle Step 1

Cycle Pre-Wash

Duration 10 minutes

Tap Water Temperature 50°C / 122°F ± 5°C / 9°F

2

Wash

10 minutes

60°C / 140°F ± 5°C / 9°F

3 4

Rinse Cool

10 minutes 5 minutes

90°C / 194°F ± 5°C / 9°F ---

5

Dry

---

---

1 2 3

Terg-A-Zyme is a trademark of Alconox, Inc. HAMO is a trademark of Steris Group GmbH Corporation. Renuzyme is a trademark of Getinge USA, Inc.

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Comments Do not use detergents or additives. Drain when complete. Follow instructions from manufacturer of washer-disinfector for optimal mix ratio and concentrations of enzyme detergent. Drain when complete. Drain when complete. Remove parts from washer-disinfector and cool at room temperature. Allow to air dry or dry the instrument with a clean, disposable, absorbent, non-shedding wipe.

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Sterilization Sterilize instruments before each use. CAUTION: Sterilization temperatures must not exceed 138°C/280°F. NOTE: Higher temperatures or longer sterilization times may be used; however; increasing the sterilization time or temperature (not to exceed 138°C/280°F) of the stated cycles may reduce instrument life. Table 2. Sterilization Parameters Pre-Vac Sterilization Low Temperature Cycle

High Temperature Cycle

Temperature

121°C / 250°F

132°C / 270°F

Sterilization Time

30 minutes

Temperature Sterilization Time

121°C / 250°F 30 minutes

3 minutes Gravity Displacement Sterilization Low Temperature Cycle High Temperature Cycle 132°C / 270°F 6 minutes

Reprocessing Option 2 Automated Cleaning, Washer-Disinfector Method The automated washer-disinfector method described below was validated using STERIS 4 Synergy 5 washer-disinfector, model E3023-2. Prior to placing instruments in the washer-disinfector, remove visible blood soil under cold tap water with a soft bristle brush. Secure the instruments in the washer-disinfector and perform the following programmed cleaning cycle. After each cleaning cycle, inspect instruments for signs of cracking, crazing, or degradation that may affect function. Table 3. Automated Washer-Disinfector Cycle Step 1

Cycle Pre-Wash

Duration 2 minutes

Cycle Requirements Cold tap water

Comments Do not use detergents or additives. Drain when complete.

2

Alkaline Detergent Wash

5 minutes

55-60°C / 131-140°F Drain when complete. Neodisher 6 MediClean forte 7, diluted to 0.5% (v/v)

3 4 5

Neutralizing Rinse Intermediate Rinse Disinfection Rinse

5 minutes 4 minutes 5 minutes

~25°C / 77°F tap water Cold tap water 93°C / 199°F tap water

Drain when complete. Drain when complete. Drain when complete.

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Dry

--

--

Allow to air dry

STERIS and Synergy are trademarks of Steris Corporation. STERIS and Synergy are trademarks of Steris Corporation. Neodisher trademark is owned by CHEMISCHE FABRIK DR. WEIGERT GMBH & CO. KG 7 pH10.4 – 10.8 (2 – 10ml/l, determined in deionized water, 20°C). In tap water or softened water as well as with carried-over pre-rinsing water, the pH value may vary - Neodisher MediClean forte Technical Data Sheet, 05/2015. 4 5 6

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Sterilization Sterilize instruments before each use. CAUTION: Sterilization temperatures must not exceed 138°C/280°F. NOTE: Higher temperatures or longer sterilization times may be used; however; increasing the sterilization time or temperature (not to exceed 138°C/280°F) of the stated cycles may reduce instrument life. Table 4. Sterilization Parameters Pre-Vac Sterilization Temperature

134°C/273°F

Time

5 minutes

Accessories The following optional accessories may be purchased separately:

Universal Tissue Holder Handle, Model UT2000 The UT2000 8 Holder Handle is part of the TF2000 Sizer Set and can also be ordered separately. It is made with a Nitinol section that provides flexibility during implantation of the Trifecta™ Valves. It can be extended in length by using it with the Rigid Extension Handle, Model EX2000-R.

Rigid Holder Handle, Model UT2000-R The Rigid Holder Handle Model UT2000-R 9 is made of stainless steel to provide a more rigid feel than the UT2000 Holder Handle. The UT2000-R can be used in place of the UT2000 Holder Handle to facilitate proper handling of all Trifecta™ Valves. Do not bend the UT2000-R Holder Handle.

Rigid Extension Handle, Model EX2000-R The Rigid Extension Handle, Model EX2000-R 10 is made of stainless steel and provides additional length with which to facilitate proper handling of all Trifecta™ Valves, when used with a holder handle. Do not bend the EX2000-R Extension Handle.

Disassembly After Use Remove the valve holder from the handle. Discard the holder that is supplied with the valve.

Disposal The instructions for use is recyclable. Dispose of all packaging materials as appropriate. Dispose of accessories per standard solid biohazard waste procedures.

Limited Warranty The user must comply with the terms and conditions of this limited warranty in order for this limited warranty to apply. St. Jude Medical warrants that if the Product does not comply with the written specifications for the Product, then St. Jude Medical will accept a return of the Product for replacement for so long as the user requires the Product for use in Devices may not be available in all countries. Please see your local St. Jude Medical representative. Devices may not be available in all countries. Please see your local St. Jude Medical representative. Devices may not be available in all countries. Please see your local St. Jude Medical representative.

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State: Released Date: 2019.06.25 15:06 GMT

connection with the sizing or implantation of the St. Jude Medical valve product(s) identified in the instructions for use, subject to the other terms of this Limited Warranty including:  The Product must be used in accordance with the instructions for its use and maintenance.  The Product must be returned for analysis to: Abbott Roseville Distribution Center Attn: Postmarket Surveillance 2305 Walnut Street Roseville, MN 55113  The user must inspect the Product upon receipt and regularly thereafter in accordance with the instructions for its use. If, at any time, the user believes that the Product has any defect or otherwise does not comply with its written specifications, the user must immediately stop using the Product and must make a report to St. Jude Medical within fifteen (15) days (contact SJM Customer Service).  All Product returned to St. Jude Medical becomes the property of St. Jude Medical. St. Jude Medical will determine whether the returned Product qualifies for warranty coverage. ST. JUDE MEDICAL DOES NOT WARRANT THE SUITABILITY OF A PRODUCT FOR ANY SPECIFIC PATIENT, SINCE FITNESS FOR USE IS A MEDICAL DECISION. Since handling, storage, cleaning, and sterilization of this Product as well as factors relating to the patient, diagnosis, treatment, surgical procedures, and other matters beyond SJM’s control directly affect this Product and the results obtained from its use, THIS WARRANTY IS IN LIEU OF AND ST. JUDE MEDICAL HEREBY DISCLAIMS AND EXCLUDES, ALL OTHER WARRANTIES, REPRESENTATIONS, OR CONDITIONS, WHETHER EXPRESS OR IMPLIED BY OPERATION OF LAW OR OTHERWISE, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY, NON INFRINGEMENT, COURSE OF DEALING, QUIET ENJOYMENT, OR FITNESS FOR A PARTICULAR PURPOSE. ST. JUDE MEDICAL WILL NOT BE RESPONSIBLE FOR ANY INDIRECT, SPECIAL, COVER, PUNITIVE, CONSEQUENTIAL, INCIDENTAL OR OTHER DAMAGES DIRECTLY OR INDIRECTLY ARISING FROM THE USE OF OR RELATED TO THE PRODUCT. SJM’S SOLE LIABILITY AND YOUR SOLE REMEDY RELATED TO THE PRODUCT IS THE REPLACEMENT DESCRIBED IN THIS LIMITED WARRANTY. IN NO EVENT SHALL ST. JUDE MEDICAL BE LIABLE TO YOU OR ANY THIRD PARTY FOR ANY CLAIM OR DAMAGES, HOWEVER ARISING, IN AN AMOUNT THAT EXCEEDS THE PRODUCT’S COST. Some countries do not allow limitations on how long an implied warranty lasts or the exclusion of incidental or consequential damages, so the preceding limitation or exclusion may not apply to you. THE REMEDIES SET FORTH IN THIS WARRANTY WILL BE THE ONLY REMEDIES AVAILABLE TO ANY PERSON. NO PERSON HAS ANY AUTHORITY TO BIND ST. JUDE MEDICAL TO ANY WARRANTY OR REPRESENTATION EXCEPT THOSE SPECIFICALLY CONTAINED HEREIN. THE ABOVE DISCLAIMERS AND LIMITATIONS SHALL BE CONSTRUED TO COMPLY WITH APPLICABLE LAW AND THIS LIMITED WARRANTY SHALL BE REFORMED ACCORDINGLY AS NECESSARY TO COMPLY WITH APPLICABLE LAW.

Australian Warranty This warranty is given by St. Jude Medical (SJM). To make inquiries regarding this warranty, use the contact information for either the manufacturer or Australian Sponsor located on the back cover. Our goods come with guarantees that cannot be excluded under the Australian Consumer Law. You are entitled to a replacement or refund for a major failure and compensation for any other reasonably foreseeable loss or damage. You are also entitled to have the goods repaired or replaced if the goods fail to be of acceptable quality and the failure does not amount to a major failure.

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State: Released Date: 2019.06.25 15:06 GMT

The benefits to you given by this warranty are in addition to your other rights and remedies under the Australian Consumer Law. SJM warrants to the buyer that the goods, for a period equal to the validated shelf life of the goods (the "Warranty Period"), shall meet the product specifications established by the manufacturer when used in accordance with the manufacturer's instructions for use and shall be free from defects in materials and workmanship. Unless otherwise obligated by law or mandatory consumer guarantees, under this warranty SJM will, at its option, replace or repair the goods at its factory, if the buyer, at the buyer's expense, returns the goods within the Warranty Period to SJM to the address below and after SJM confirms that the goods are defective. Abbott Attn: Postmarket Surveillance Roseville Distribution Center 2305 Walnut Street Roseville, MN 55113 Tel.: (651) 756-2000 To the maximum extent permitted by law, if a mandatory term is implied by law or a mandatory consumer guarantee applies to the goods, and the goods are not of a kind ordinarily acquired for personal, domestic or household use or consumption, SJM’s liability for the breach of the term or guarantee is limited to, at SJM’s option, either replacement or repair of the goods or payment of the costs of replacing or repairing the goods. EXCEPT FOR MANDATORY TERMS IMPLIED BY LAW, MANDATORY CONSUMER GUARANTEES, OR AS EXPRESSLY PROVIDED IN THIS WARRANTY, ST. JUDE MEDICAL DISCLAIMS ANY REPRESENTATION OR WARRANTY OF ANY KIND, EXPRESS OR IMPLIED. See the Terms and Conditions of Sale for further information.

Symbols Symbol

Description Catalog Number Lot Number Date of Manufacture Non-Sterile

Manufacturing facility

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State: Released Date: 2019.06.25 15:06 GMT

Symbol

Description Authorized EC Representative in the European Community Consult instructions for use Follow instructions for use on this website Manufacturer Quantity, package contents Do not use if package is damaged Confirmite Europeenne (European Conformity). Affixed in accordance with European Council Directive 93/42/EEC. Hereby, St. Jude Medical declares that this device is in compliance with the essential requirements and other relevant provisions of this directive. USA only: Federal law restricts this device to sale by or on the order of a Physician Australian Sponsor

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State: Released Date: 2019.06.25 15:06 GMT

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St. Jude Medical 177 County Road B, East St. Paul, MN 55117 USA +1 855 478 5833 +1 651 756 5833

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