Reusable Instruments
Instructions for Cleaning the Instruments
To ensure the reliability of functionality of the Cavernotomes, clean the instruments before initial use and after each procedure. The following are suggested manual and automated methods of cleaning.
Manual Method
- Soak the instruments in an enzyme cleaner suitable for stainless steel instruments.
- Wash in surgical detergent and disinfection solution at a temperature of 86°F to 95°F (30°C to 35°C). Remove any contamination of body fluids or tissues using a soft brush.
- Place the instruments in an ultrasonic bath with fresh detergent solution for approximately 10 minutes or follow the instructions below if using an automatic washing cycle.
- Rinse thoroughly in a stream of fresh tap water followed by towel drying. The instruments may be treated with instrument lubricant.
Automated Method
For use of automatic washing cycle suitable for stainless steal instruments, follow the cycle below:
- Rinse/wet cycle, cold water- 1 minute
- Wash 176°F (80°C) – 12 minutes
- Rinse cycle – 1 minute
- Rinse cycle – 12 minute
- Final rinse – 2 minutes
- Rinse with demineralized water 176°F (80°C) – 2 minutes
- Dry 199.4°F (93°C) – 10 minutes
Sterilization Recommendations for Reusable Instruments
The Cavernotomes are supplied nonsterile. To steralize, steam autoclave prior to each use. Steam autoclave at a temperature of 270°F to 284°F (132°C to 140°C) for a minimum of 4 minutes (pre-vacuum). It is the responsibility of the end user to ensure sterility of the product when using the sterilization process recommended, since bioburden and sterilization equipment will vary.
Chemical Sterilization
Critical items confer a high risk for infection if they are contaminated with any microorganism. Thus, objects that enter sterile tissue must be sterile because any microbial contamination could transmit disease. This category includes surgical instruments, urinary catheters, and ultrasound probes used in sterile body cavities. Most of the items in this category should be purchased as sterile or be sterilized with steam if possible. Heat-sensitive objects can be treated with EtO, hydrogen peroxide gas plasma; or if other methods are unsuitable, by liquid chemical sterilants. Germicides categorized as chemical sterilants include ≥2.4% glutaraldehyde-based formulations, 0.95% glutaraldehyde with 1.64% phenol/phenate, 7.5% stabilized hydrogen peroxide, 7.35% hydrogen peroxide with 0.23% peracetic acid, 0.2% peracetic acid, and 0.08% peracetic acid with 1.0% hydrogen peroxide. Liquid chemical sterilants reliably produce sterility only if cleaning precedes treatment and if proper guidelines are followed regarding concentration, contact time, temperature, and pH.