Harmonic Decontamination and Sterilization

Instructions for Use Verify compatibility of all instruments and accessories prior to using the instrument (refer to Warnings and Precautions). 1. Prior to use, remove and discard the protective cover over the Blade Mount Surface. 2. Before initial use, clean and sterilize the Hand Piece as per recommended Instructions for Reprocessing included in this insert. 3. Prior to each use, visually inspect the Hand Piece for damage that may have occurred during handling and cleaning, and verify that the instrument functions properly and is not in need of maintenance or repair. Refer to Inspection section for details of the visual inspection. Instructions for Reprocessing • This device is supplied non-sterile and must be cleaned and sterilized prior to initial and each subsequent use. • Thorough cleaning is necessary to ensure correct mechanical functioning of the device. • Each device must be treated individually and matte surfaces must be protected against scratches. • The design of this device permits effective cleaning and reliable sterilization. The user must ensure that cleaning and sterilization are performed in accordance with guidelines, standards and National Health Authority requirements. Point of Use Treatment (in the operating room) • Clean device as soon as possible after use. • Remove excessive solids using disposable lint free wipes, enzymatic foam or per hospital procedure. Soiled devices should be separated from unsoiled devices. Soiled Devices should be covered with a lint free towel dampened with tap, sterile or critical water to prevent blood and/or debris from drying. Encrusted soil can increase the time and effort required to complete processing. • If the recommendations in the steps above are not possible, the device may be placed in a container and immersed in tap, sterile or critical water and covered for transport to the processing area. Caution: To minimize the chance of corrosion, do not use saline for cleaning. • Follow the Cleaning and Sterilization instructions below. Containment and Transportation Surgically used devices may be considered bio-hazardous and should be safely transported to a designated processing area in accordance with hospital procedures and local policies. Cleaning (after procedure) Cleaning should be performed as soon as possible after use, preferably within one hour of use. The device has 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. 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 they are corrosive. The user must ensure that cleaning and sterilization are conducted in accordance with the appropriate guidelines, standards, or National Health Authority requirements. Hospital grade low foaming neutral pH to mildly alkaline enzymatic detergents, hospital grade low foaming neutral pH detergents (pH 7-9) and hospital grade low foaming mildly alkaline detergents with a pH of ≤ 11 (prepared according to manufacturer’s instructions) should be used. “Detergent(s)” will be used generically throughout the rest of these instructions. Ensure that detergent manufacturer instructions are followed for concentration, temperature and water quality throughout the cleaning process. When using mildly alkaline detergents, critical water should be used throughout the cleaning process. Further information regarding the use of specific cleaning agents, ultrasonic washers, washer-disinfectors, packaging materials or sterilizers during validation studies is available on request. Ethicon used the following detergents during validation of the processing recommendations: Manual Cleaning: Manual Pre-Cleaning with Enzol® Enzymatic Detergent – 8 mL/L at 32-39°C Ultrasonic Cleaning with Enzol® Enzymatic Detergent – 8 mL/L at 32-39°C Automated Cleaning:

1

Ultrasonic Cleaning with Cidezyme® Enzymatic Detergent – 8 mL/L at 20-25°C Washer-disinfectors cleaning with neodisher® MediClean forte – 2 mL/L at 55°C The chemical quality of the water used during processing can impact device safety. Facilities should use the recommended water quality requirements for device processing in accordance with local guidance (such as AAMI TIR34, Water for the reprocessing of medical devices), detergent manufacturers and these instructions for use. Critical water is recommended for thermal disinfection and final rinsing of devices. For the purpose of these instructions for use, critical water is defined as a treatment process that may include deionization (DI), reverse osmosis (RO) or distillation. Pre-cleaning Instructions (PRIOR to Automatic or Manual Cleaning) 1. Immerse and soak the device for a minimum of 10 minutes up to 60 minutes in an enzymatic detergent or equivalent prepared according to manufacturer’s instructions for concentration, water quality and temperature. 2. Remove the device from the detergent. 3. Immerse the device in a clean sink with cold to warm tap water – not to exceed 40°C. Using a toothbrush style soft bristle (nylon) brush or soft lint free cloth, clean the exterior of the device paying particular attention to crevices, threads and seams. Caution: Do not use scouring pads, abrasive cleaners, or a steel wire brush, which may cause damage to the surfaces of the device. 4. Rinse the exterior of the device thoroughly under cold to warm running tap water for a minimum one minute. 5. Completely immerse the device in an ultrasonic cleaner that contains fresh enzymatic detergent and sonicate for a minimum 5 minutes. The frequency should be 25 to 50 kHz – target 38 kHz. Follow manufacturer’s instructions for concentration, water quality and temperature. 6. Remove the device from the ultrasonic cleaner and rinse under cold to warm running tap water for a minimum of one (1) minute. Following the pre-cleaning step, the validated automated or manual processing method must be performed. Refer to standard hospital protocol and local/national practices to determine whether disinfection is required. Note that disinfection is mandatory in some areas of the world; e.g. EU. There are different A0 requirements in various countries; e.g, A0 ≥600 (90°C for 1 minute) or A0 ≥3000 (90°C for 5 minutes). The user must ensure that cleaning, disinfection and sterilization are conducted in accordance with the appropriate local guidelines, standards, or National Health Authority requirements. Automated Cleaning Method (Preferred Method) Following the pre-cleaning step, the device must be cleaned/disinfected in a validated automated washerdisinfector in compliance to ISO 15883 or equivalent standard, using a typical non-lubricating Instrument, Vario TD Cycle or a program similar to the following cycle, providing the minimum parameters identified below are met: Phase

Recirculation Time (minutes:seconds)

Temperature

Detergent Type

Validated Parameters

Pre-Wash

02:00

Cold tap water

N/A

2 minutes cold tap water

Enzyme Wash

02:00

Tap water <40°C (104°F)

Neutral pH enzymatic detergent or mildly alkaline detergent

no

Wash

03:00

Tap water ≥40°C (104°F)

Neutral pH detergent or mildly alkaline detergent

5 minutes tap water 55-60°C

Rinse

02:00

Critical water >40°C (104°F)

N/A

2 minutes critical water

2

*Thermal Disinfection

01:00 – 10:00

Critical water ≥90°C (194°F)

N/A

5 minutes at 90°C

Drying

30:00

≥115°C (239°F) – not To exceed 134°C (273°F)

N/A

30 minutes at 115°C

Note: Do not expose the device to a lubrication cycle. Note: The automated washer program may or may not include and enzymatic wash phase. Single or combined washing phases should be performed for a minimum of 5 minutes. Temperatures used during the enzymatic and/or wash phases should meet the requirements of the detergent manufacturer’s recommendations. Disinfection Thermal disinfection can be included as part of the automatic cleaning cycle. The device may be thermally disinfected at a temperature between 90°C (194°F) and 100°C (212°F) for one (1) minute up to ten (10) minute(s) to render the device safer for handling. Manual Cleaning Method 1. Immerse the device for a minimum 5 minutes in a detergent prepared in accordance with manufacturer’s recommendations for concentration, water quality and temperature. 2. Remove the device from the detergent. 3. Immerse the device in a clean sink with cold to warm critical water – not to exceed 40°C. While immersed, use a toothbrush style, soft bristle (nylon) brush or soft lint free cloth to clean the exterior of the device. Pay particular attention to crevices, threads and seams. Caution: Do not use scouring pads, abrasive cleaners, or a steel wire brush, which may cause damage to the surfaces of the device. 4. Rinse the exterior of the device thoroughly with critical water for a minimum one minute.. Drying Dry the device with a clean, absorbent lint free cloth. If a washer-disinfector without a drying cycle is used, a hot-air dryer may be used but the device must not be heated to temperatures above 134°C (273°F). The cavities of device parts must be blown out with clean, compressed air, up to 20 psi, in order to eliminate the possibility of any residual water remaining. Inspection Devices do not have an indefinite functional life. All surgical devices are subject to a degree of wear and tear as a result of normal use. They must therefore undergo a regular and precise visual check before each use: • Inspect the test tip body or blade wrench for cracks • Inspect the TLB01 torque wrench for cracks, damage or visual signs of wear. • Ensure the complete removal of soil from all test tip or blade wrench surfaces. If soil or blood is present, clean the device following Pre-Cleaning and Automated or Manual Cleaning Instructions. Discard and replace the instrument if damage or degradation is present. Defective instruments (malfunctioning or difficult to operate instruments and those with stress, corrosion, cracking or pitting, etc.) increase the risk to the patient and must therefore not be used. Sterilization Steam (moist heat) sterilization is recommended in an approved, pre-vacuum cycle listed below. The steam sterilizer must be FDA cleared, if performed in the United States, and validated to the requirements of any local standards and guidance such as EN285, ISO17665 or AAMI/ANSI ST8. Prepare Device for Sterilization 1. Place and wrap device in an approved sterile barrier wrap material per hospital protocol and in accordance with ISO11607-1 and any other local and/or National requirements using standardized wrapping techniques. Or place device in a sterilization tray wrapped using an approved sterile barrier material and standardized wrapping techniques. 2. Place wrapped device or wrapped tray into autoclave. 3. Run the device through the autoclave using one of the settings below.

3

The following steam sterilization cycle parameters are approved for use. Sterilization in EU Sterilizer Type

Method

Pre-vacuum Wrapped

Cycle Time Temperature Preconditioning Pulses (minimum time Set Point (Minimum) at Temperature) 3 minutes 134°C (273°F) 3

Drying Time 15 minutes

Sterilization in US or other applicable countries Sterilizer Type

Method

Preconditioning Pulses (Minimum)

Drying Time

Pre-vacuum Wrapped Pre-vacuum Wrapped Gravity Wrapped

Cycle Time Temperature (minimum time Set Point at Temperature) 4 minutes 132°C (270°F) 3 minutes 134°C (273°F) 15 minutes 132°C (270°F)

3 3 Not applicable

15 minutes 15 minutes 15 minutes

Gravity

30 minutes

Not applicable

15 minutes

Wrapped

121°C (250°F)

Notes: 1. The above table includes the minimum temperature and cycle time validated to assure sterility. 2. Based on steam autoclave tolerances, the actual autoclave temperature can exceed the set point temperature by a maximum of +3°C (+5°F). 3. Health Authorities in some regulated regions do not accept unwrapped sterilization methods; e.g. in the EU. Please review the appropriate guidelines, standards and National Health Authority guidelines when determining acceptable steam sterilization process parameters for use in each respective country. 4. Immediate-use steam sterilization is only intended for individual devices and should only be performed when approved by local policies. Immediate-use steam sterilization of devices is not supported. It is the sole responsibility of the user to validate immediate-use steam sterilization if performed. STERRAD® Systems 1. Clean and thoroughly dry the HARMONIC Test Tip or Blade Wrench following the steps listed in the Cleaning section. 2. Using standardized wrapping techniques, place and wrap the device in an approved STERRAD® Systemcompatible polypropylene sterilization wrap in accordance with hospital protocol, the STERRAD® Operator’s Manual, and ISO11607-1. Or place device in a sterilization tray wrapped using an approved sterile barrier material and standardized wrapping techniques approved for use in a STERRAD® System. Do not use paper pouches or sterilization wraps containing cellulose or cotton. 3. Sterilize the Test Tip and Blade Wrench within the STERRAD® System according to the instructions provided in the STERRAD® Operator’s Manual. Refer to the table below for STERRAD® Systems and corresponding sterilization cycle times. STERRAD® System STERRAD® 100NX STERRAD® 100S STERRAD NX® STERRAD® 200

Purpose For general surgical instrumentation Rigid & Tubing (2x400 mm SS; 1x350 mm tubing) Rigid & tubing

Cycle Time Standard 47 minutes Short 54 minutes Standard 28 minutes Standard 75 minutes

Undesirable Side Effects/Residual risk Undesirable side effects and risks associated with ultrasonic devices include the potential for bleeding, tissue injury via mechanical or thermal damage, introduction of non-sterile surfaces or pathogen transfer, inflammatory or unintended tissue reaction, electrical shock, foreign body or magnetic resonance incompatibility, and property or environmental damage. Also, unintended harm, extended surgery, or altered surgical approach may result from issues related to device activation, damaged devices, electromagnetic interference, audible noise due to misassembly, misuse of the torque wrench, or an attempt to alter the device.

4

Standard Conventions Used The use of a WARNING, a Caution or a Note statement Information relative to the completion of a task in a safe and thorough manner will be supplied in the form of a WARNING, Caution or a note statement. These statements are found throughout the documentation. These statements should be read before continuing to the next step in a procedure. WARNING: A warning statement indicates an operating or maintenance procedure, practice, or condition that if not strictly observed could result in a personal injury or loss of life. Caution: A Caution statement indicates an operating, or maintenance procedure, practice, or condition that, if not strictly observed, could result in damage to or destruction of the equipment. Note: A Note statement indicates an operating, or maintenance problem, practice, or condition that is necessary to accomplish task efficiently. WARNING • Improper reprocessing or resterilization may compromise the functional performance of the device or lead to device failure which in turn may result in patient injury or illness. • Improper reprocessing or resterilization of reusable devices may create a risk of contamination or cause infection or cross-infection, including, but not limited to, the transmission of infectious diseases. Contamination may lead to injury, illness, or death. • Instruments or devices which come into contact with bodily fluids may require special disposal handling to prevent biological contamination. Disposal of all medical device instruments and accessories should be performed according to local requirements and regulations. • Inspect the blade wrench hub for cracks or wear before use. If damage is seen, replace the blade wrench. The blade wrench should be cooled to room temperature for a minimum of 45 minutes following autoclaving prior to use. • The Steam table content includes the minimum temperature and time validated to assure sterility. Based on steam autoclave tolerances, the actual autoclave temperature can exceed the set point temperature by a maximum of +3°C (+5°F). • To minimize the chance of corrosion, do not use saline for cleaning. • Follow the instructions and warnings issued by the suppliers of any cleaning and disinfecting agents and equipment used. Avoid exposing the instruments to hypochlorite solutions, as these will promote corrosion. Do not use cleaning agents with chlorine or chloride as it is corrosive. Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the local competent authority of the country in which the user and/or patient is established. Storage and Transportation Conditions Keep Dry Keep Away from Heat Storage Conditions Temperature: -35 °C to + 54 °C Relative Humidity: 10% to 90% Sterilized products should be stored in a dry, clean environment, protected from direct sunlight, dust, pests, and extreme temperature and humidity. Refer to sterilization wrap manufacturer’s IFU for limits on sterile product storage time. The third party trademarks used herein are the trademarks of their respective owners.

5

en: Refer to instruction manual/booklet bg: Вижте ръководството/книжката с инструкции cs: Prostudujte si návod k použití / brožuru da: Se brugervejledningen/-håndbogen de: Siehe Gebrauchsanleitung/Broschüre el: Ανατρέξτε στο εγχειρίδιο/φυλλάδιο οδηγιών es: Consulte el manual/folleto de instrucciones et: Vt kasutusjuhendit/brošüüri fi: Lue ohjekirja fr: Consulter le mode d’emploi/la notice hr: Pogledajte priručnik/brošuru s uputama hu: Lásd az utasításokat tartalmazó kézikönyvet/füzetet id: Lihat manual/buklet petunjuk it: Fare riferimento al libretto/manuale di istruzioni lt: Žiūrėkite naudojimo vadovą / brošiūrą

en: Batch code bg: Партиден номер cs: Číslo šarže da: Partikode de: Chargencode el: Κωδικός παρτίδας es: Código de lote et: Partii kood fi: Eräkoodi fr: Numéro de lot hr: Šifra serije hu: Tételkód id: Kode batch it: Codice lotto lt: Partijos kodas en: Manufacturer bg: Производител cs: Výrobce da: Fabrikant de: Hersteller el: Κατασκευαστής es: Fabricante et: Tootja fi: Valmistaja fr: Fabricant hr: Proizvođač hu: Gyártó id: Produsen it: Fabbricante lt: Gamintojas

lv: Skatiet instrukciju rokasgrāmatu/ brošūru mk: Видете во прирачникот/брошурата со упатства nl: Raadpleeg de instructiehandleiding/ het instructieboekje no: Se instruksjonshåndboken/-heftet pl: Należy zapoznać się z instrukcją/ broszurą pt: Consulte o folheto/manual de instruções ro: Consultați manualul/broșura de instrucțiuni ru: Ознакомьтесь с инструкциями в руководстве или буклете sk: Prečítajte si manuál/leták sl: Glejte priročnik/knjižico z navodili sr: Погледајте приручник/брошуру са упутствима sv: Se instruktionshandboken/broschyren tr: Talimat kılavuzuna/kitapçığına başvurun vi: Tham khảo tài liệu/ sách hướng dẫn zh: 请参阅说明手册/宣传册 lv: Partijas kods mk: Сериски број nl: Lotcode no: Partikode pl: Kod partii pt: Código do lote ro: Cod lot ru: Код партии sk: Kód šarže sl: Koda serije sr: Број серије sv: Satskod tr: Parti kodu vi: Mã lô zh: 批号

lv: Ražotājs mk: Производител nl: Fabrikant no: Produsent pl: Producent pt: Fabricante ro: Producător ru: Производитель sk: Výrobca sl: Proizvajalec sr: Произвођач sv: Tillverkare tr: Üretici vi: Nhà sản xuất zh: 制造商

HST02, TLB01, TTBLUE

Johnson & Johnson Medical GmbH Robert-Koch-Strasse 1 22851 Norderstedt Germany

Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969 USA 1-877-ETHICON +1-513-337-8901 (English) ©Ethicon Endo-Surgery, Inc. 2021 Rev. 2022-04-30 A001628 Rev B