ETHICON PROXISURE Sterilization Tray Instructions for Use

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Implemented: 07/18/2016 Latest Released: YES 4

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State: Released NSR/SR: Saleable

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en Implemented: 07/18/2016 Latest YES Automatic Released: Cleaning and Disinfection of the PROXISURE Sterilization Tray without a PROXISURE Suturing

Device Description The PROXISURE Sterilization Tray is a reusable, stainless steel device container intended for use in the sterilization and resterilization of the PROXISURE™ Suturing Device. Silicone device holders in the bottom of the tray are used to stabilize and protect the device during transport, cleaning, sterilization and storage. A graphic of the device is etched into the bottom of the tray to indicate proper placement of the device in the tray. It is supplied non-sterile and must be cleaned and sterilized prior to use. Illustrations and Nomenclature (Illustration 1) 1. Sterilization Tray 2. Lid 3. Device Holders 4. Fasteners Cleaning and Decontamination These cleaning instructions have been validated for preparing the PROXISURE Suturing Device and PROXISURE Sterilization Tray for reuse. The PROXISURE Suturing Device and PROXISURE Sterilization Tray have been designed for thorough cleaning and safe sterilization, without disassembly. It is the responsibility of the end user to ensure that the cleaning is performed using appropriate equipment, materials and personnel to achieve the desired result. Additionally, ensure that detergent residuals are sufficiently removed. Perform a final rinse on device using critical or high purity water (e.g. reverse osmosis, deionized, or distilled). Multiple rinses may be required. Refer to the manufacturer’s recommendations for the removal of detergent residuals.

State: Released NSR/SR: Saleable

Caution: Follow the instructions and warnings issued by the suppliers of any cleaning agents and equipment used. Avoid exposing devices to hypochlorite solutions, as these will promote corrosion. Do not use cleaning agents with chlorine or chloride as it is corrosive. The user must ensure that cleaning and sterilization are conducted in accordance with the appropriate guidelines, standards, or National Health Authorities’ requirements. All accessories, equipment, and supplies used in the cleaning, decontamination, and sterilization of the PROXISURE Sterilization Tray should be approved for use by the appropriate regional health authority. Neutral pH detergents and neutral pH enzymatic detergents (prepared according to manufacturer’s instructions) should be used. Neodisher® Mediclean Forte may also be used. When using Neodisher® Mediclean Forte, critical or high purity water (e.g. reverse osmosis, deionized, or distilled) should be used throughout the cleaning process. Prior to sterilization, the device and sterilization tray must be thoroughly pre-cleaned and cleaned by either automated or manual methods. Pre-cleaning Instructions 1 Immerse the tray for at least 10 minutes in a neutral pH enzymatic detergent (e.g. diluted Enzol® or equivalent prepared according to manufacturer’s instructions). 2 While immersed, use a soft bristle (nylon) brush to clean the tray. Caution: Do not use scouring pads, abrasive cleaners, or a steel wire brush, which may cause damage to the tray. 3 Rinse the tray thoroughly under running tap water for at least a minute. Note: If the water is not visibly clear, repeat steps 1-3. Refer to the PROXISURE Suturing Device insert for instructions on cleaning and sterilization of the PROXISURE Suturing Device using the PROXISURE Sterilization Tray. If the tray is not used for cleaning the device, follow the instructions below for cleaning the tray.

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Device (Option 1) 1 Place the tray (without the lid on it) in the automatic washer. 2 Set the automatic washer to “Instrument Cycle” or an equivalent cycle. This cycle must include an enzymatic wash, rinse, neutral pH detergent wash, rinse (with critical or high purity water, e.g. reverse osmosis, deionized, or distilled), and drying. After removing the tray from the Automatic Washer, ensure it is dry. Additional drying can be done using a clean, absorbent cloth or up to 20 psi pressurized air. Note: Drying should not exceed 273°F (134°C). Optional Thermal Disinfection for the Sterilization Tray A high-level thermal disinfection step can be included as part of the automatic cleaning cycle. The tray may be thermally disinfected at greater than 200°F (93°C) for a minimum of 5 minutes to render the tray safe for handling. Note: Do not exceed 212°F (100°C) for longer than 10 minutes. Manual Cleaning of the PROXISURE Sterilization Tray without a PROXISURE Suturing Device (Option 2) 1 Immerse the tray for at least 10 minutes in a neutral pH detergent (or Neodisher® Mediclean Forte). 2 While immersed, use a soft bristle (nylon) brush to clean the interior and exterior of the tray. Pay particular attention to interior corners of the tray. Caution: Do not use scouring pads, abrasive cleaners, or a steel wire brush, which may cause damage to the tray. 3 Rinse the tray thoroughly with critical or high purity water (e.g. reverse osmosis, deionized, or distilled) for at least a minute. Note: If the water is not visibly clear, repeat process starting with step 1 of the Pre-cleaning Instructions, then steps 1-3 above. 4 Dry the tray with a clean, absorbent cloth or up to 20 psi pressurized air. Inspection and Functional Testing after Cleaning Inspect all sterilization trays for damage prior to sterilization. WARNING: Sterilization trays are subject to wear and tear as a result of normal use. End of useful life of the tray is generally determined by wear or damage from handling. If after repeated cleaning cycles, soil or blood is still present on the tray, the tray is beyond its useful life. If the inspection and functional testing below fails, the tray is beyond its useful life. Replace if damaged, worn or bent. Do not attempt to straighten or repair. If an improperly functioning or damaged tray is used, this may lead to patient injury. 1

Inspect the tray to verify there are no cracks, loose rivets, or sharp edges in the tray. Ensure that the closure system functions properly. Ensure there are no cracked or missing device holders. Do not use the tray if it shows signs of damage.

Autoclave Sterilization Following the cleaning and decontamination steps above, the PROXISURE Sterilization Tray can be used to sterilize the PROXISURE Suturing Device. Caution: The PROXISURE Suturing Device must be sterilized using an autoclave. It has not been validated for other sterilization processes. Prepare Device for Sterilization 1 Ensure flush port is open and luer cap is tethered to the port (Illustration 2). WARNING: The flush port must be open during cleaning and sterilization. If the flush port is not open during cleaning and sterilization, the cleaning process may be less effective and sterility of the device may be compromised. 2 Place the device in the PROXISURE Sterilization Tray. 3 Use the device graphic for placement and ensure device securely snaps into the device holders. Ensure the distal tip is aligned with the shaft of the device and the jaws are parallel (Illustration 3).

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Implemented: 07/18/2016 Latest Released: YES Notes:

Caution: Do not load more than one PROXISURE Suturing Device in the sterilization tray as it may result in damage to the jaws and other parts of the device and compromise sterilization. The sterilization tray with its contents must not weigh more than 6 lbs (2.7 kg). Place lid on tray and secure fasteners (Illustration 4). Wrap the closed tray in a FDA-cleared barrier wrap material per hospital protocol using standardized wrapping techniques.

Sterilization Handle the PROXISURE Suturing Device according to hospital protocol throughout the sterilization process. 1 Place wrapped tray into autoclave. Caution: Do not externally stack the sterilization tray in the autoclave as it may compromise sterilization of the device. 2 Run device through autoclave using one of the settings below. The following autoclave cycle parameters are approved for use. Sterilizer Type

Method

Cycle Time (at temperature)

Temperature Set Points

Preconditioning Pulses

Drying Time

Prevacuum

Wrapped

4 minutes

270°F (132°C)

3

50 minutes

Prevacuum

Unwrapped

3 minutes

270°F (132°C)

3

50 minutes

Gravity

Wrapped

15 minutes

270°F (132°C)

Not applicable

50 minutes

State: Released NSR/SR: Saleable

The following autoclave cycle parameters are approved for use outside the US. Sterilizer Type

Method

Cycle Time (at temperature)

Temperature Set Points

Preconditioning Pulses

Drying Time

Prevacuum

Wrapped

Minimum of 3 minutes

273°F (134°C)

3

50 minutes

Prevacuum

Unwrapped

Minimum of 3 minutes

273°F (134°C)

3

50 minutes

Gravity

Unwrapped

15 minutes

273°F (134°C)

Not applicable

50 minutes

Gravity

Wrapped

15 minutes

273°F (134°C)

Not applicable

50 minutes

• • • •

The above table includes the minimum temperature and cycle time validated to assure sterility. Based on steam autoclave tolerances, the actual autoclave temperature can exceed the set point temperature by a maximum of +5°F (+3°C). Sterilization and drying set point should not exceed 273˚F (134°C). Health Authorities in some regulated regions do not accept unwrapped sterilization methods. Please review the appropriate guidelines, standards and National Health Authorities’ guidelines when determining acceptable steam sterilization process parameters for use in each respective country.

Warnings • Sterilization trays are subject to wear and tear as a result of normal use. End of useful life of the tray is generally determined by wear or damage from handling. If after repeated cleaning cycles, soil or blood is still present on the tray, the tray is beyond its useful life. If the inspection and functional testing in the Inspection and Functional Testing after Cleaning section fails, the tray is beyond its useful life. Replace if damaged, worn or bent. Do not attempt to straighten or repair. If an improperly functioning or damaged tray is used, this may lead to patient injury. • The flush port must be open during cleaning and sterilization. If the flush port is not open during cleaning and sterilization, the cleaning process may be less effective and sterility of the device may be compromised. • Devices that come into contact with bodily fluids may require special disposal handling to prevent biological contamination. Precautions • Do not use scouring pads, abrasive cleaners, or a steel wire brush, which may cause damage to the tray. • Do not store trays in liquid. • The PROXISURE Suturing Device must be sterilized using an autoclave. It has not been validated for other sterilization processes. • Do not load more than one PROXISURE Suturing Device in the sterilization tray as it may result in damage to the jaws and other parts of the device and compromise sterilization. The sterilization tray with its contents must not weigh more than 6 lbs (2.7 kg). • Do not externally stack the sterilization tray in the autoclave as it may compromise sterilization of the device. • Follow the instructions and warnings issued by the suppliers of any cleaning agents and equipment used. Avoid exposing devices to hypochlorite solutions, as these will promote corrosion. Do not use cleaning agents with chlorine or chloride as it is corrosive. Storage Conditions After sterilization, store devices in a manner that provides protection from dust, moisture, insects, vermin and extremes of temperature and humidity. How Supplied The PROXISURE Sterilization Tray is supplied non-sterile.

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Implemented: 07/18/2016 Latest Released: YES

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Non-Sterile ‫غير معقم‬ Nesterilní Ikke-steril Unsteril Μη αποστειρωμένο No estéril Steriloimaton Non stérile Nesterilno Nem steril Non sterile 비멸균 상태 Niet-steriel Ikke sterilt Niejałowe Não Esterilizado Нестерильно Nesterilné Nesterilno Osteril Steril değil 非灭菌 非滅菌

Implemented: 07/18/2016 Latest Released: YES

Packaging Unit ‫وحدة التعبئة‬ Balicí jednotka Emballeringsenhed Verpackungseinheit Μονάδα συσκευασίας Unidades en el envase Pakkausyksikkö Unité d’emballage Jedinično pakiranje Csomagolási egység Unità di confezioni 포장 단위 Verpakkingseenheid Emballasjeenhet Ilość sztuk w opakowaniu Unidade de Embalagem Упаковочная тара Jednotka balenia Enota pakiranja Förpackningsenhet Ambalajlama ünitesi 包装单位 包裝單位

Manufacturer/Date of Manufacture ‫تاريخ التصنيع‬/‫جهة التصنيع‬ Výrobce/Datum výroby Producent/fremstillingsdato Hersteller/Herstellungsdatum Κατασκευαστής/Ημερομηνία κατασκευής Fabricante/Fecha de fabricación Valmistaja/valmistuspäivä Fabricant/date de fabrication Proizvođač/Datum proizvodnje Gyártó/gyártás dátuma Fabbricante/Data di fabbricazione 제조업체/제조일 Fabrikant/Fabricagedatum Produsent/produksjonsdato Producent/Data produkcji Fabricante/Da ta de Fabrico Производитель/дата изготовления Výrobca/dátum výroby Izdelovalec/datum izdelave Tillverkare/Tillverkningsdatum İmalatçı/İmalat tarihi 制造商/生产日期 製造廠/生產日期

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Implemented: 07/18/2016 Latest Released: YES P000217P02

State: Released NSR/SR: Saleable

CNPST

Johnson & Johnson Medical Ltd. Simpson Parkway Kirkton Campus Livingston EH54 7AT United Kingdom

ECN NO

A

ECN012927

PRODUCT CODE(S)

ETHICON, LLC 475 C Street Los Frailes Industrial Park Suite 401 Guaynabo, Puerto Rico 00969 USA 1-877-ETHICON +1-513-337-6928 © Ethicon Endo-Surgery, Inc. 2016

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CNPST

CHNG

KU

DATE

07-07-2016

PACKAGE AND LABELING DRAWING NUMBER

PACKAGE COMPONENT NUMBER

INK R-SPEC NUMBER

RELEASE STATUS

A000417P00

P000217P02

R3024-01

SR

CONFIDENTIAL : NOT TO BE REPRODUCED OR USED IN ANY WAY WITHOUT WRITTEN APPROVAL FROM ETHICON ENDO-SURGERY, INC., CINCINNATI, OH

REVISIONS LTR

BLACK Rev. 2016-07-31

P000217P02

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