Medtronic 750 Instructions for Use

Simulus™

Ring/Band Accessories

Instructions for Use

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

The following list includes trademarks or registered trademarks of Medtronic in the United States and possibly in other countries. All other trademarks are the property of their respective owners.

Medtronic, Simulus

Explanation of symbols on package labeling

Refer to the device labeling to see which symbols apply to this product.

Conformité Européenne (European Conformity). This symbol means that the device fully complies with applicable European Union acts.

Consult instructions for use

Lot number

Catalog number

For US audiences only

Quantity

Manufacturer

Nonsterile

Authorized representative in the European Community

Manufactured in

1 Device description

The Simulus ring/band accessories consist of nonsterile reusable metal handles, with Nitinol stems that straighten during the steam sterilization cycle, and clear plastic sizers.

Use the following Simulus ring/band accessories for the Simulus flexible annuloplasty ring, Model 700FF, and the Simulus flexible annuloplasty band, Models 700FC and 725FC:

Accessory Model Product Description

750 Simulus flexible ring/band acces-

sory kit

• 9 rigid polysulfone sizers, sizes 23 mm through 39 mm

• 2 standard annuloplasty handles

• 1 sterilization tray

751 Simulus flexible ring/band polysul-

fone sizer set

• 9 rigid polysulfone sizers, sizes 23 mm through 39 mm

755 Simulus flexible ring/band robotic

accessory kit

• 9 polysulfone robotic sizers, sizes 23 mm through 39 mm

• 1 sterilization tray

Use the following Simulus ring/band accessories for the Simulus semi-rigid annuloplasty ring, Model 800SR, and the Simulus semi-rigid annuloplasty band, Model 800SC:

Accessory Model

850 Simulus semi-rigid ring/band

Product Description

accessory kit

Accessory Model Product Description

• 9 rigid polysulfone sizers, sizes 24 mm through 40 mm

• 2 standard annuloplasty handles

• 1 sterilization tray

851 Simulus semi-rigid ring/band poly-

sulfone sizer set

• 9 rigid polysulfone sizers, sizes 24 mm through 40 mm

The handles have malleable Nitinol stems that straighten during the steam sterilization cycle. The handles are available in the following lengths and quantities:

Accessory Model Length Quantity

752 254 mm 2

2 Indications for use

The sizers are to be used to size a patient’s mitral or tricuspid valve annulus in order to select the proper size Simulus ring or band.

Do not use other manufacturers’ annuloplasty sizers or sizers from other annuloplasty products to size the Simulus ring or band. Other sizers may not indicate the appropriate Simulus ring or band size.

3 Contraindications

The sizers are not intended for use with devices other than the Simulus ring or band.

4 Warnings and precautions

4.1 Warnings

• The sizers and handles are provided NONSTERILE and must be thoroughly cleaned and sterilized prior to use.

• Only surgeons who have received appropriate training in valve repair, including ring implant and sizing techniques, should use this device.

• Correct annuloplasty ring or band sizing is an important element of a successful valve repair. Undersizing the ring or band can result in:

– valve stenosis – ring or band dehiscence – ring or band fracture

• Oversizing the ring or band can result in: – valve regurgitation – ring or band fracture

• Do not force the sizer through the annulus as patient injury may occur.

• Carefully inspect each sizer and handle prior to use for cracks or flaws that may result from sterilization, handling, or general use. Discard any sizer or handle that shows signs of cracking or degradation.

4.2 Precautions

• Do not apply excessive force when engaging the handle to the sizer, as this may damage the sizers.

• Do not use solvent-based cleaners (for example, acetone or toluene) when cleaning the sizers or handles. Use water-soluble surfactant-type soaps or mild detergents as cleaning agents.

5 Instructions for use

Refer to the Simulus ring or band Instructions for Use for information regarding the sizing and implantation of the Simulus ring or band.

The handle has a spring quick-release catch that engages in a corresponding square recess in each sizer. Two small protrusions on the base of the handle correspond with recesses in the upper face of each sizer to prevent the handle from being incorrectly snapped into place on the lower face of the sizer. The metal shaft of the handle is made of bendable Nitinol wire that straightens during the steam sterilization cycle. To engage the sizer and the handle, gently insert the handle into the square recess of the sizer. To disengage the sizer, gently squeeze the spring and then pull the handle away from the sizer.

The flexible sizers have a small hole. Tying a length of 2/0 (or larger) suture to the sizer using the side hole may help with sizer removal later. The flexible silicone rubber sizers may be rolled up to fit the access port before introduction to the right atrium. Once in place, the flexible sizer may be gripped by a suitable instrument using the 2 off-center holes in the sizer.

6 How supplied

6.1 Packaging

The sizers and handles are supplied NONSTERILE. Thoroughly clean and sterilize the sizers and handles prior to use and each reuse. For reuse, completely disassemble the sizer from the handle prior to cleaning (for example, detach the handle and sizer).

6.2 Storage

The sizers and handles are intended to be stored indefinitely and may be reused with appropriate cleaning and sterilization.

7 Processing and Reprocessing

Medtronic has validated the following instructions 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. Processing requires validation and routine monitoring. Likewise, any deviation by the processor from the following instructions should be properly evaluated for effectiveness and potential adverse consequences. Cleaning may be done manually, or it may be automated according to these Instructions for Use or an equivalent, validated method.

7.1 Cleaning

Warning: Thoroughly clean the device to eliminate soil prior to sterilization.

Warning: Do not use solvent-based cleaners (for example, acetone or

toluene).

• Do not allow contaminated devices to dry before implementing any cleaning procedure.

• Reprocess devices within 2 hours after use. If transport to the processing area will be delayed, place the device in a covered container with an enzymatic detergent to prevent drying.

• If the device contains multiple components, completely disassemble the components prior to cleaning per these Instructions for Use.

• Examine the device for cracking or degradation prior to use. Do not use the device if any components show signs of cracking or degradation.

• Thermal disinfection is not required because the devices are terminally sterilized.

7.1.1 Manual Cleaning

Medtronic has established the following manual cleaning procedure in Table 1. These steps must be performed within a maximum of 2 hours after use.

Note: If the device has movable parts, ensure that all surface areas have been thoroughly cleaned.

Table 1. Manual Cleaning Instructions

Tempera-

Step Process

ture Cleaning Instructions

1 Rinsing >27°C

(>81°F)

Remove gross soil using running water for 1 min. Use a soft-bristle brush (for example, a nylon toothbrush) to clean the device thoroughly.

2 Soaking >28°C

(>82°F)

Submerge the device completely for a minimum of 5 min with 15.6 mL/1 L (or 2 ounces/1 gallon) of an enzymatic detergent (for example, ENZOL™) and water. Remove visible soil with a soft-bristled brush.

3 Ultrasonic

Clean

>27°C

(>81°F)

Submerge the device completely in an ultrasonic cleaner (for example, Bransonic™) with 7.8 mL/1 L (or 1 ounce/1 gallon) of an enzymatic detergent (for example, ENZOL) and water. Sonicate for 10 min.

4 Rinsing >27°C

(>81°F)

Rinse the device with running water for

1 min. 5 Drying N/A Dry with a clean, lint-free wipe. 6 Inspection N/A Visually inspect each device for any

remaining soil or moisture. If soil

remains, repeat the process.

7.1.2 Automated Cleaning

Medtronic has established the following automated cleaning procedure. The steps in Table 2 must be performed within a maximum of 2 hours after use.

Note: If the device or component has movable parts, ensure that all surface areas have been thoroughly cleaned.

Table 2. Pretreatment Instructions

Water tempera-

Step Process

ture Cleaning Instructions

1 Rinsing >25°C (>77°F) Remove gross soil using running

tap water.

2 Soaking >25°C (>77°F) Submerge the device com-

pletely for a minimum of 1 min with 7.8 mL/1 L (or 1 ounce/1 gallon) of an enzymatic deter-

Table 2. Pretreatment Instructions (continued)

Water tempera-

Step Process

ture Cleaning Instructions

gent (for example, ENZOL) and water. Remove visible soil with a soft-bristled brush (for example, a nylon toothbrush).

3 Rinsing >25°C (>77°F) Rinse the device for a minimum

of 2 min.

4 Inspec-

tion

N/A Visually inspect the device for

any remaining soil. If needed, repeat the process.

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.

1. Place the device in an automated washer (for example, Steris Reliance™ Genfore™ Washer/Disinfector).

Note: Avoid contact between devices while loading the washer.

2. Set the automated washer to run the parameters identified in Table 3 and allow the automated washer to complete the wash cycle.

Table 3. Automated Washer Cleaning Parameters

Treatment

Time

(min)

Tempera-

ture Cleaning Agent

Enzymatic

Wash

04:00 ≥60°C

(≥140°F)

Steris Prolystica™ Ultra Concentrate Enzymatic Cleaner diluted as 1.0 mL/1 L (or 0.125 ounce/1 gallon).

Wash 02:00 ≥60°C

(≥140°F)

Steris Prolystica™ Ultra Concentrate Neutral Detergent diluted as

1.0 mL/1 L (or 0.125 ounce/1 gallon).

Rinse 02:00 ≥60°C

N/A

(≥140°F)

Dry 15:00 ≥82°C

N/A

(≥180°F)

Inspection N/A N/A Visually inspect each device for

any remaining soil or moisture. If soil remains, repeat the process. If

Table 3. Automated Washer Cleaning Parameters (continued)

Treatment

Time

(min)

Tempera-

ture Cleaning Agent

needed, dry the device with filtered, compressed air or a lintfree wipe.

7.2 Steam Sterilization and Resterilization

• Use standard packaging material. Ensure that the pack is large enough to contain the device without stressing the seals. When validating the sterilization processes, Medtronic used the appropriate accessory tray for each device.

• Medtronic validated steam cycles when the devices were wrapped by CSR (Central Supply Room) wrap. However, the steam sterilization process can be completed when the devices are either unwrapped or wrapped in steam sterilization compatible materials.

• When sterilizing multiple devices in 1 autoclave cycle, do not exceed the sterilizer’s maximum load.

• Examine the device for cracking or degradation prior to use. Do not use the device if components show signs of cracking or degradation.

• Some non-US health care authorities recommend sterilization cycle parameters that 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 4. Sterilization Cycle Parameters

Cycle type

Prevacuum

(Dynamic-

Air-Removal)

Prevacuum

(Dynamic-Air-

Removal)

Prevacuum

(Dynamic-Air-

Removal) for CJD

Temperature 132°C (270°F) 135°C (275°F) 134°C (273°F)

Exposure

4 min 3 min 18 min

Time

Dry Time

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 134°C to 137°C (273°F to 279°F) for a single cycle of 18 min or multiple cycles totaling 18 min (for example, six 3 min cycles).

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.

30 min 16 min 30 min

8 Disclaimer of Warranty

THE FOLLOWING DISCLAIMER OF WARRANTY APPLIES TO UNITED STATES CUSTOMERS ONLY:

ALTHOUGH THE SIMULUS RING/BAND ACCESSORIES, HEREAFTER REFERRED TO AS “PRODUCT”, HAVE BEEN MANUFACTURED UNDER CAREFULLY CONTROLLED CONDITIONS, MEDTRONIC HAS NO CONTROL OVER THE CONDITIONS UNDER WHICH THIS PRODUCT IS USED. MEDTRONIC, THEREFORE, DISCLAIMS ALL WARRANTIES, BOTH EXPRESS AND IMPLIED, WITH RESPECT TO THE PRODUCT, 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 PRODUCT, WHETHER A CLAIM FOR SUCH DAMAGES IS BASED UPON WARRANTY, CONTRACT, TORT, OR OTHERWISE. NO PERSON HAS ANY AUTHORITY TO BIND MEDTRONIC TO ANY REPRESENTATION OR WARRANTY WITH RESPECT TO THE PRODUCT.

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.

9 Disclaimer of warranty

THE FOLLOWING DISCLAIMER OF WARRANTY APPLIES TO CUSTOMERS OUTSIDE THE UNITED STATES:

ALTHOUGH THE SIMULUS RING/BAND ACCESSORIES, HEREAFTER REFERRED TO AS “PRODUCT”, HAVE BEEN CAREFULLY DESIGNED, MANUFACTURED, AND TESTED PRIOR TO SALE, THE PRODUCT MAY FAIL TO PERFORM ITS 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 PRODUCT. MEDTRONIC SHALL NOT BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES CAUSED BY ANY USE, DEFECT, OR

FAILURE OF THE PRODUCT, WHETHER THE CLAIM IS BASED ON WARRANTY, CONTRACT, TORT, OR OTHERWISE.

Medtronic, Inc.

*M999028A001*

710 Medtronic Parkway Minneapolis, MN 55432 USA www.medtronic.com +1 763 514 4000 LifeLine Technical Support, 24-hour consultation service: 1 877 526 7890

Medtronic, Inc. 3800 Annapolis Lane Minneapolis, MN 55447 USA Customer service and product orders: 1 800 854 3570

Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands +31 45 566 8000

Canada

Medtronic of Canada Ltd 99 Hereford Street Brampton, Ontario L6Y 0R3 Canada 1 800 268 5346

Medtronic 750 Instructions for Use

Specifications and Main Features

Frequently Asked Questions

User Manual

1 Device description

2 Indications for use

3 Contraindications

4 Warnings and precautions

4.1 Warnings

4.2 Precautions

5 Instructions for use

6 How supplied

6.1 Packaging

6.2 Storage

7 Processing and Reprocessing

7.1 Cleaning

7.1.1 Manual Cleaning

Table 1. Manual Cleaning Instructions

7.1.2 Automated Cleaning

Table 2. Pretreatment Instructions

Table 3. Automated Washer Cleaning Parameters

7.2 Steam Sterilization and Resterilization

Table 4. Sterilization Cycle Parameters

8 Disclaimer of Warranty

9 Disclaimer of warranty