Holder Hand Instructions for Use

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DESCRIPTION...2 INDICATIONS...3 CONTRAINDICATIONS...3 COMPONENTS...3 STORAGE... 3 PRECAUTIONS...3 DIRECTIONS FOR USE...4 Reprocessing Requirements...5 Reprocessing Option 1...6 Reprocessing Option 2...8 DISASSEMBLY AFTER USE...10 DISPOSAL...10 LIMITED WARRANTY...10 AUSTRALIAN WARRANTY...13

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TABLE OF CONTENTS

DESCRIPTION St. Jude Medical provides optional handle models MHV-HHR1, MHV‑HHL1, MHV-HHL21, MHV-HHL31 (hereafter referred to collectively as the handles), to facilitate minimally invasive sizing and implantation of St. Jude Medical™ mechanical heart valves. See Table 1, below for handle specifications: Table 1 Model Number

Length (in/cm)

Rigid/Flexible

MHV-HHR

9.6 / 24.4

Rigid

MHV-HHL1

9.0 / 22.9

Flexible

MHV-HHL2

9.6 / 24.4

Flexible

MHV-HHL3 10.1 / 25.6 Flexible Flexible handles may 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. Do not bend rigid MHV-HHR handles. The handles are compatible with the following products: • SJM™ Masters Series Mechanical Heart Valve Model series AHPJ‑505, AEHPJ-505, MHPJ-505, MEHPJ-505, AFHPJ-505, AJ-501, AECJ-502, MJ-501, MECJ-502, ATJ-503, MTJ-503, METJ‑504 • SJM Regent™ Mechanical Heart Valve Model series AGN-751, AGFN-756 1

Subject to availability

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INDICATIONS The handles are indicated for use with those products listed in the Description section of this manual.

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

COMPONENTS The product package includes one handle model MHV-HHR, MHV‑HHL1, MHV-HHL2, or MHV-HHL3.

STORAGE The non-sterile handles 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). 3

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• Extension handle Models EX-05 and EX2000-R • 35 and 37 mm mitral valve sizer rings, Models 905-35 and 905-37

• Do not bend flexible instrument handles beyond a 90° angle. • All instruments must be sterilized in a tray or container that is permeable to steam. • Do not expose instruments to cleaning or rinse agents that are not compatible with polyphenylsulfone.

DIRECTIONS FOR USE Press the straight, sterilized handle into the mechanical valve holder/ rotator receptacle. Verify that the handle is seated securely. Screw the sterilized extension handle model EX-05 or EX2000-R into the sterilized handle model MHV-HHR, MHV-HHL1, MHV-HHL2, or MHV-HHL3 (Figure 1). Verify that the extension handle is securely attached.

Figure 1

NOTE: When using the handle/extension handle combination to rotate mechanical valves, clockwise rotation is recommended. Counter-clockwise rotation could unscrew the extension handle from the base handle. 4

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. 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.

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When using the handles with 35 mm and 37 mm sizer rings, hold the sterilized sizer ring so that you can see the size printed on the ring. Screw the sterilized handle into the ring until the pins on the handle are flat against the ring. See the instructions for use packaged with the applicable implantable device for detailed sizing, handling, and implantation instructions. The handles have been designed and tested for repeated use. However, if visual signs of deterioration become apparent, please contact your customer service representative.

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™ Enzymatic Cleaner (Alconox) for five minutes. 4. Items should be mechanically cleaned with appropriately sized nonabrasive 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™ LS1000 washerdisinfector with Renuzyme™ 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: 6

Cycle

Duration

Tap Water Temperature

Comments

1

PreWash

10 minutes

50°C / 122°F ± 5°C / 9°F

Do not use detergents or additives. Drain when complete.

2

Wash

10 minutes

60°C / 140°F ± 5°C / 9°F

Follow instructions from manufacturer of washerdisinfector for optimal mix ratio and concentrations of enzyme detergent. Drain when complete.

3

Rinse

10 minutes

90°C / 194°F ± 5°C / 9°F

Drain when complete.

4

Cool

5 minutes

----

Remove parts from washerdisinfector and cool at room temperature.

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Dry

----

----

Allow to air dry or dry the instrument with a clean, disposable, absorbent, nonshedding wipe.

Sterilization Sterilize instruments before each use. CAUTION: Sterilization temperatures must not exceed 138°C/280°F. 7

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Step

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. Pre-Vac Sterilization

Temperature Sterilization Time

Low Temperature Cycle

High Temperature Cycle

121°C/250°F

132°C/270°F

30 minutes

3 minutes

Gravity Displacement Sterilization Low Temperature Cycle

High Temperature Cycle

Temperature

121°C/250°F

132°C/270°F

Sterilization Time

30 minutes

6 minutes

Reprocessing Option 2 Automated Cleaning, Washer-Disinfector Method The automated washer-disinfector method described below was validated using STERIS™ Synergy™ 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. 8

Cycle

Duration

Cycle Requirements

Comments

1

Pre-Wash

2 minutes

Cold tap water

Do not use detergents or additives. Drain when complete.

2

Alkaline Detergent Wash

5 minutes

55-60°C / 131140°F Neodisher™ MediClean forte2, diluted to 0.5% (v/v)

Drain when complete.

3

Neutralizing Rinse

5 minutes

~25°C tap water

Drain when complete.

4

Intermediate Rinse

4 minutes

Cold tap water

Drain when complete.

5

Disinfection Rinse

5 minutes

93°C tap water

Drain when complete.

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Dry

--

--

Allow to air dry

After each cleaning cycle, inspect instruments for signs of cracking, crazing, or degradation that may affect function.2 Sterilization Sterilize instruments before each use. 2. pH10.4 – 10.8 (2 – 10 ml/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.

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Step

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. Pre-Vac Sterilization Parameters Temperature

134°C/273°F

Time

5 minutes

DISASSEMBLY AFTER USE Pull on the handles to disengage them from the mechanical valve holder/rotators. Unscrew the handles from the 905-35 and 905-37 sizers, or the EX-05 and EX2000-R extension handles. Handles must be disassembled prior to cleaning and sterilization.

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. 10

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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 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 12

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. 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 13

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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.

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.

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VERKLARING, BEHALVE GARANTIES OF VERKLARINGEN DIE SPECIFIEK IN DIT DOCUMENT VERMELD STAAN. DE BOVENSTAANDE DISCLAIMERS EN BEPERKINGEN DIENEN TE WORDEN OPGEVAT ALS CONFORM AAN DE GELDENDE WETTEN, EN DEZE BEPERKTE GARANTIE DIENT DIENOVEREENKOMSTIG TE WORDEN HERZIEN INDIEN NODIG OM AAN DE GELDENDE WET TE KUNNEN VOLDOEN.

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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 sjm.com St. Jude Medical Australia Pty Limited 17 Orion Rd., Lane Cove NSW 2066 AUSTRALIA

Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, LLC and its related companies. Renuzyme is a trademark of Getinge USA, Inc. HAMO is a trademark of Steris Group GmbH Corporation Neodisher trademark is owned by CHEMISCHE FABRIK DR. WEIGERT GMBH & CO. KG STERIS and Synergy are trademarks of Steris Corporation Terg-A-Zyme is a trademark of Alconox, Inc. Pat. http://patents.sjm.com

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2019/05