INVUITY Sterilization Trays Instructions for Use

Sterilization Trays - Instructions for Use Description The Invuity Sterilization Tray is used during steam sterilization. The Sterilization Tray is available in plastic and metal material and available in multiple sizes.

Indications for Use The Invuity Sterilization Tray is intended to allow transport and sterilization of enclosed medical device(s).

Contraindications There are no known contraindications.

Warnings and Precautions Cleaning and Sterilization: •

See “Warnings and Precautions” in the Decontamination and Sterilization section of this Instructions for Use.

Product Use: •

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Prior to use, carefully inspect the Sterilization Tray for functionality, visible cracks, loose or bent components, or rough edges. Discard damaged devices according to hospital procedures and in accordance with local, state and federal laws and regulations. When loading instruments and accessories in the Sterilization Tray, adequately space instruments far enough apart to avoid contact with other metal instruments or object which may dent, ding, scrape or otherwise damage the surface of the instrument. Refer to the Instructions for Use for the Invuity devices for additional information.

Safety: •

Use of instruments for any purpose or in any manner other than described in this Instructions for Use may cause instrument damage or failure, which could result in patient or user injury.

Directions for Use 1. Prior to use, carefully inspect the Sterilization Tray for functionality, visible cracks, loose or bent components, or rough edges. Do not use damaged trays. 2. Carefully load Invuity Fiber Optic Cables, Retractors and/or Accessories in the Sterilization Tray. 3. Sterilize the Tray and contents according to the Decontamination and Sterilization section of this Instructions for Use.

IFU 14466 Rev A

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Preparation for Cleaning Equipment and Materials WARNING: Use only Invuity-approved equipment unless otherwise specified. DO NOT modify any system component or accessory. The following equipment is required to process devices per the instructions in this manual: • Warm water (See the Water Quality section) • Prepared, specially formulated cleaning agents (See the Cleaning Agents section) • Absorbent wipes • Soft, nonlinting cloth • Syringe • Non-abrasive, soft, flexible, synthetic bristle brushes • Washer-disinfector (complies with ISO 15883 series) • Cleaning agents as required by the washer-disinfector manufacturer • Instrument air1 < 140 kPa [< 20 psi] • Oven Instrument air is medical gas that falls under the general requirements for medical gases as defined by the National Fire Protection Association (NFPA) Health Care Facilities Code, is not respired, is compliant with the American National Standards Institute (ANSI) / International Society of Automation (ISA) Quality Standard for Instrument Air, and is filtered to 0.01 microns, free of liquids and hydrocarbon vapors, and dry to a dew point of -40 °C [-40 °F].

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IFU 14466 Rev A

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Cleaning and Sterilization Clean the sterilization tray as indicated before first use. Use the cleaning methods as indicated in these instructions. Other cleaning methods may prevent proper sterilization of the equipment. • Do not use Sterrad® or other sterilization processes that contain chlorine (bleach) or enzymatic solutions. • It is recommended to use the appropriate Invuity Sterilization Tray to help protect any Invuity Fiber Optic Cable or Retractor from damage during transport, decontamination, sterilization, and storage. • Do not process instruments of different metals during sterilization, oxidation due to electrolytic effects may occur. 1. Use an enzymatic solution or a neutral pH detergent according to hospital protocol for pre-soak cleaning. Pay close attention to instructions for correct detergent dilution, temperature, and soak time. 2. Scrub the entire Invuity Sterilization Tray thoroughly using a soft brush and a neutral pH (7.0-8.5) detergent. An alkaline cleaning agent (neat, up to pH 11) is allowable, but not preferred. Alkaline cleaning agents may cause cosmetic damage or reduce the life of the product. The Invuity Sterilization Tray may be submerged when scrubbing. Take special care to thoroughly clean and remove all debris from the aeration holes. Note: Do not use a stiff bristle brush or metal type brush to clean the tray. Avoid contact with other metal instruments or object which may dent, ding, scrape or otherwise damage the surface of the Sterilization Tray. 3. Rinse the Sterilization Tray to remove residual debris and cleaning agents. WARNINGS: • Use appropriate water quality for each stage of the cleaning process. Mineral residues from hard water can stain the equipment and/or prevent effective cleaning and decontamination. • Use utility water for flushing, washing, and rinsing the equipment. Utility water is water that comes from the tap. • Use potable water for diluting cleaning agents. Potable water is water that is treated and delivered in a matter so that it meets United Sates (US) Environmental Protection Agency (EPA) or local guidelines as suitable for drinking. • Use critical water for final rinsing of the equipment prior to sterilization. Critical water is water that is extensively treated usually by a multistep treatment process that could include a carbon bed, softening, deionization, and reverse osmosis or distillation to ensure that the microorganisms and the inorganic and organic material are removed from the water. A final submicron filtration could also be part of the treatment process. •

Warnings/ Precautions

Cleaning

Water Quality

CAUTION: Poor water quality can adversely affect the life of medical devices. ALWAYS follow the water quality requirements per Association for the Advancement of Medical Instrumentation (AAMI) TIR 34. Warm water with an optimum temperature range of 27 to 44 °C [80 to 110 °F] is recommended for manual cleaning. The water should not exceed 60 °C [140 °F] and should be warm to the touch. Disinfection (Optional)

IFU 14466 Rev A

Disinfection processes do not ensure the margin of safety associated with sterilization processes. Therefore, disinfection is optional.

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The following sterilization parameters have been validated for instruments in a tray, wrapped or unwrapped. Note: Invuity endorses the following sterilization parameters per AAMI recommendations for wrapped instruments and container with combined weight of less than 25 lbs [11.3 kg]. Steam Sterilization Parameters Gravity Description Pre-Vacuum Displacement 132°C2 132-138°C Temperature (270°F) (270-280°F) Cycle Time 15 minutes1 3-8 minutes1 Dry Time 45 minutes 30 minutes

Sterilization

1 Maximum exposure time may be extended to 18 minutes.

2 Maximum sterilization temperature may be extended to 137 °C.

Note: Do not use Sterrad® or other sterilization processes that contain chlorine (bleach) or enzymatic solutions. The final responsibility for verification of sterilization techniques lies directly with the hospital. To ensure the efficacy of hospital processing, all cycles and methods should be verified for different sterilization chambers, wrapping methods, and/or various loading configurations. International sterilization parameters are per the following standards: • Australia/New Zealand per AS/NZS 4187 • Netherlands per Field Standard for Loaner Instruments, Rev 03.02, April 2008 • Europe and the United Kingdom per EN ISO 17664 • Canada per CSA ISO 17664 Storage

IFU 14466 Rev A

Store Sterilization Trays in a clean, dry area.

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Document Number IFU 14466 Rev A

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Sterilization Trays (EN, FR, IT, DE, ES)

INSTRUCTIONS FOR USE

Revision History Table Rev

CO #

A

20-0060

Description Initial Release

Approved Date

Effective Date

Originator

02/28/2020

02/28/2020

J.Clark

Document Number IFU 14466 Rev A INSTRUCTIONS FOR USE

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Sterilization Trays (EN, FR, IT, DE, ES)

PRINTING INSTRUCTIONS Print in-house or at an approved supplier and route to receiving. Do not print Revision History Table or Printing Instructions Pages (Last two pages) Print double sided, booklet style in black ink on white paper. Fold into a booklet and staple (folded size is 8.5 in x 5.5 in (REF))