MENTOR Leiden Gel Breast Implant Sizer Product Insert Data Sheet

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MANUFACTURING The device is not manufactured using phthalate containing components / materials. Furthermore the devices do not contain latex nor have been in contact with latex containing products during manufacturing. In addition the devices are not manufactured utilizing tissues of animal origin. INSTRUCTIONS FOR USE The application of the Gel Sizer involves a variety of surgical techniques. Prior to using the Gel Sizer, the physician should be familiar with all of the information provided associated with the MENTOR® Gel Breast Implants to be implanted. NOTE: It is advisable to have more than one size/shape Gel Sizer in the operating room at the time of surgery to allow the surgeon flexibility in determining the appropriate size and shape of the breast implant to be used. The Gel Sizer is supplied individually in a sterile and non-pyrogenic double-wrap packaging system. The double-wrap system facilitates the preferred method of sterile product transfer from the circulating area to the sterile field. Sterility cannot be guaranteed if the double-wrap packaging system has been damaged. This product has been sterilized by Dry Heat Sterilization. A label containing lot number, part number and volume of the device is included in the box. This label can be used by the Central Sterilization Department (CSD) for their inventory administration. CLEANING, DISINFECTING AND STERILIZATION OF THE GEL SIZER First Time Use of the Gel Sizer The Gel Sizer is supplied sterile. Therefore, the device does not have to be cleaned, disinfected and sterilized prior to first time use. Subsequent Use of Gel Sizer (Reuse) An overview of a Steam Sterilization cycle is given in Figure 1. The different phases are described below. Phase 1: Conditioning phase This phase is needed to reach saturated steam at a preset temperature (ie, set point). Air is removed, and is replaced by steam. This displacement air can occur by gravity or with use of a vacuum system. Phase 2: Sterilization phase Keep product surface temperature constant for a certain period of time (ie, holding time). Phase 3: Cooling down/ Pressure reduction When the steam has been exhausted from the chamber, the sterilizer goes into the drying phase. To achieve drying in a pre-vacuum steam sterilizer, filtered air is drawn into the chamber.

Figure 1: Overview of the different phases within a sterilization cycle

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When reusing the Gel Sizer, the device must be cleaned, disinfected and sterilized (autoclave) as indicated by the flow chart detailed in Figure 2 below. NOTE: Detailed instructions for each step are provided below Figure 2. For reference, these detailed instructions coincide with the numbered steps in Figure 2. Immediately after use in body:

Cleaning 1 Disinfecting 2 Packaging 3

Subsequent Use (Reuse) Sterilization

4 Cooling Down/ Drying

5

Record Keeping/ Storage

6

Prior to next surgery:

Testing 7

Next Surgery 8

Figure 2: Flowchart for Gel Sizer Cleaning, Disinfecting and Sterilization (Autoclave) (1) CLEANING / (2) DISINFECTING The Gel Sizer needs to be thoroughly cleaned prior to sterilization. Not appropriately removing all organic material from the Gel Sizer will have a negative impact on sterilization effectiveness. MANUAL Cleaning steps: Use surgical gloves during all procedures. • Preclean the device by removing all excess soil and immersing the Gel Sizer in cold, demineralised water for 5 minutes. • Clean the Gel Sizer under running demineralised water with a soft brush until all visible residues are removed. • Clean the device by hand for a minimum of 3 minutes in a solution of water and Neodisher US detergent (or equivalent) for enzymatic cleaning at a temperature between 25°C and 32°C. The device may also be cleaned with a 1% anionic, alkaline detergent or mild surgical soap. • Wipe the Gel Sizer with a cloth to remove all residue until it is visibly clean. • After the cleaning, the Gel Sizer must be soaked in the detergent solution for 10 minutes. • Rinse the Gel Sizer copiously (at least 3 times) with demineralised water to make sure all detergent is removed. • Visually inspect the Gel Sizer thoroughly for cleanliness. • If necessary, repeat the cleaning process again until the Gel Sizer is visibly clean. Disinfecting and drying steps: • After completion of the cleaning steps, the Gel Sizer must be wiped with alcohol (Isopropyl Alcohol 70%) for proper disinfection. • Dry the Gel Sizer using a lint free towel. AUTOMATIC Cleaning steps: Place the Gel Sizer on an instrument rack (Miele E 327-06 or equivalent) and in the washer/disinfector machine (Miele 7735 CD or equivalent). Start the cycle. • 2 minutes precleaning with cold water • Draining cycle • 5 minutes cleaning at 55°C with 0.5% alkaline detergent (Neodisher FA or equivalent) • Draining cycle • 3 minutes neutralizing with warm water (>40°C) and neutralizer (Neodisher Z or equivalent)

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13157-03 • Draining cycle • 2 minutes rinsing with warm water (>40°C) • Draining cycle

NOTE: Any special instructions of the manufacturer of the automated washer/disinfector machine should be followed. Automated disinfecting and drying steps: • Apply the automated Thermal Disinfection procedure for the washer/disinfector machine following applicable regional or national A0 -Value requirements (see ISO15883-1, ISO/TS 15883-5). • Dry the Gel Sizer by using the drying cycle of washer/ disinfector machine. • If needed, additional manual drying can be performed using lint free towel. • Visually inspect the Gel Sizer thoroughly for cleanliness. • If necessary, perform the cleaning and disinfecting process again until the Gel Sizer is visibly clean. (3) PACKAGING: Double wrap the Gel Sizer in surgical sterilization wrap intended for autoclave use. NOTE: Use sterilization wrap and not a pouch to accommodate the flow of the steam during the sterilization process. See ISO 11607-1 Annex A. Packaging for terminally sterilized medical devices. (4) STERILIZATION Place the unit in an open, clean autoclaving tray and autoclave with a validated Steam Sterilization method that fits into the following ranges: • Heat up to a sterilization temperature of a minimum of 134°C and a maximum of 136°C. • Select a minimum of 3 minutes and a maximum of 40 minutes holding time. • Select a minimum drying time of 10 minutes. • Apply a fractionated prevacuum process (according to EN 285/ISO 17665) by considering the respective country requirements. Each autoclave manufacturer has its own mode for the prevacuum phase and therefore the user must ensure that the conditions necessary for the sterilization phase are obtained. • Use as many prevacuum pulses as needed to deair the autoclave chamber for the Gel Sizer. However, do not use a deeper vacuum than 75 millibar of absolute pressure. Mentor recommends a vacuum of 200 millibar of absolute pressure to maintain the shape of the product. NOTE: The sterility boundary is reached at 134°C, with a 3 minute holding time. For the physical boundary of the Gel Sizer do not exceed 136°C, with a holding time of 40 minutes. Mentor has found that this cycle range achieves product sterility and maintains the integrity of the Gel Sizer. However, Mentor recommends that the hospital should qualify this process with its own machine to prove that this combination results in a sterile product. Alternative cycles can be used. • Alternate Steam Sterilization cycles: • Standard Cycle: 20 minutes at 121°C • Optional Cycle: 18 minutes at 134°C • Gravity Displacement Sterilization cycles: • Standard Cycle: 30 minutes at 121°C and 15 psi (1 bar) • Optional Cycle: 20 minutes at 132°C and 30 psi (2 bar) If the cycle available for the autoclave is not one of the Steam Sterilization or Gravity Displacement Sterilization cycles described above, please contact the autoclave manufacturer to program and validate one of these sterilization cycles. NOTES: If individual policies and procedures require an autoclave step for decontamination prior to cleaning, this counts as a sterilization and reduces the number of times the device may be reused. The Gel Sizer may rupture while still hot from the autoclave and could require up to 45 minutes to cool based on Gel Sizer volume. Care must be used during handling to avoid damage while hot. Because packaging methods, packaging materials and storage conditions may vary from one healthcare facility to another, Mentor cannot determine the shelf life for devices sterilized outside of our manufacturing facility. The shelf life of a packaged sterile item is event related. An event must occur to compromise package content sterility. Refer to current AORN Standards, Recommended Practices and Guidelines for the selection and use of packaging systems. Sterile packaged devices should not be stacked and should be stored under environmentally controlled conditions for temperature and humidity. Provided the packaging instructions are followed, the device will remain sterile to the date determined by individual policies and procedures for event-related sterility in preoperative settings. (5) COOLING /DRYING: • After autoclaving, allow the device to completely cool prior to use to avoid possible tissue damage from residual heat release. • Allow the Gel Sizer to dry in the autoclave until outer wrap is entirely dry. • Let the Gel Sizer cool down for at least 2 hours before sterilizing it again. NOTE: Do not dry the device using a vacuum cycle. NOTE: In this phase, a gradual pressure reduction is better for maintaining the shape of the product. Too steep a pressure reduction may result in bubble formation in the gel, which may result in deformation of the shell/ gel combination (ie, shape).

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(6) RECORD KEEPING/STORAGE Record the following information on the Sterilization Record Card: (i) Date of cleaning and sterilization. (ii) Name of the person who performed the sterilization. NOTE: The Gel Sizer and the card should be kept together to ensure accurate recording of sterilization data. (7) TESTING: The Gel Sizer should be tested for patency and shell integrity immediately prior to each use. This can be accomplished by gently manipulating the device with hand and fingers, while carefully examining for leakage sites. (8) NEXT SURGERY: Make sure that the Gel Sizer is cleaned and disinfected immediately after use in the body. After the Gel Sizer has been resterilized and inserted ten (10) times, discard device in accordance with applicable policies for biohazardous waste disposal. Dispose of material in accordance with all federal, state and local regulations. Responsibility for proper waste disposal is with the owner of the waste. PRODUCT EVALUATION Mentor requests that physicians notify the company of complications which occur with the use of this device. Any complications should be brought to the immediate attention of your local Mentor representative, who will be responsible for informing the Product Evaluation Department at Mentor Product Evaluation, 3041 Skyway Circle North, Irving, TX, USA, 972-252-6060. RETURNED GOODS AUTHORIZATION Authorization for return of merchandise should be obtained from your local Mentor representative prior to return of merchandise. Merchandise returned must have all manufacturer’s seals intact. PRODUCT INFORMATION DISCLAIMER Mentor expressly disclaims all warranties, whether written or oral, statutory, express or implied by the operation of law or otherwise, including, but not limited to, any implied warranties of merchantability, fitness or design. Mentor shall not be liable for any direct, incidental or consequential loss, damages or expense, indirectly arising from the use of this product. No representation or other affirmation of fact, including but not limited to statements regarding suitability for use, or performance of the product shall be or be deemed to be a warranty by Mentor for any purpose. Mentor neither assumes nor authorizes any other or additional liability or responsibility in connection with this device. PRODUCT ORDER INFORMATION For product information or to order directly, contact your local Mentor representative. DEFINITIONS OF SYMBOLS ON LABELING Quantity One

Catalogue Number

Batch Code

Serial number

Use By

CAUTION

Sterilized using steam or dry heat

Width, Height, Projection

CE-mark and Identification number of Notified Body. The product meets the essential requirements of Medical Device Directive 93/42/EEC

Diameter, Projection

Resterilizable Gel Sizer Cleaning and Sterilization Record

Title of Sterilization Record Card

Manufacturer

Please keep this card with the device

Instruction on Sterilization Record Card to keep card with the device.

Date of Manufacture

Sterilization

Process to sterilize the Gel Sizer (Steam Sterilization)

DATE:

Date Gel Sizer was sterilized

NAME:

Name of person conducting the sterilization process

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For customer service or to return product, please call (31) 71 7513600 or your local representative.

Mentor Medical Systems B.V. Zernikedreef 2 2333 CL Leiden The Netherlands (31) 71 7513600

© Mentor Worldwide, LLC 2015

IFU PRINTING SPECIFICATION SHEET

7.677" (195 mm)

BINDING Perfect Bound

6.5" (165 mm)

TITLE

DESCRIPTION

LAB NUMBER

SPECIAL INSTRUCTIONS/COMMENTS

BINDING

COLORS

MENTOR® Gel Sizer

PIDS

LAB100069624v3

N/A

Perfect Bound

Black

FLAT SIZE

FINISHED SIZE

RMC NUMBER

PAGE COUNT

N/A

6.5" x 7.677" 165 mm x 195 mm

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168 + 4 Cover

BLEED SIZE .5" (12.7 mm) .125" (3.175 mm)

NONE

BLEED ALL SIDES

BLEED TOP BLEED RIGHT BLEED LEFT BLEED BOTTOM

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STOCK Cover: 180 g/m2 Sulfate board cover | Pages: 50 g/m2 woodfree offset

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