Invuity ST2B User manual

IFU 14466 Rev A
Sterilization Trays
ST2B / ST1C
Instructions for Use
Invuity, Inc.
444 De Haro Street
San Francisco, CA 94107
USA
Tel: [phone]
www.invuity.com
Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands
Consult Instructions for Use and Symbols
Glossary on this website:
www.invuity.com/documentlibrary

IFU 14466 Rev A 2
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:
•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 3
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
1Instrument 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].

IFU 14466 Rev A 4
Cleaning and Sterilization
Warnings/
Precautions
•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.
Cleaning
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.
Water
Quality
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.
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)
Disinfection processes do not ensure the margin of safety associated with sterilization processes.
Therefore, disinfection is optional.

IFU 14466 Rev A 5
Sterilization
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
Description
Gravity
Displacement
Pre-Vacuum
Temperature
132°C2
(270°F)
132-138°C
(270-280°F)
Cycle Time
15 minutes1
3-8 minutes1
Dry Time
45 minutes
30 minutes
1Maximum exposure time may be extended to 18 minutes.
2Maximum 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 Store Sterilization Trays in a clean, dry area.