Integra LifeSciences Catheters, Female and Catheter-Dilators, Walther - Manual

Description
Integra® Female Catheters and Walther Catheter-Dilators are used for medical or
surgical procedures that facilitate direct or intermittent drainage of the urinary
bladder. The female catheters are reusable and are provided clean and supplied
non-sterile.
Indications For Use
Integra® Female Catheters and Dilator-Catheters are urological catheters used to
drain urine/fluid from the urinary tract for intermittent decompression of the
bladder during surgical procedures.
Contraindications
• Integra® Female Catheters and Walther Catheter-Dilators are not to be used with
traumatic urethral injuries.
Warnings
DO NOT flash sterilize the Integra® Female Catheters and Walther Catheter-
Dilators. These instruments have not been validated for flash sterilization.
Damage to the product may occur if inappropriate cleaning/disinfecting agents are
used or if exposed to excessive temperatures.
Precautions
• Discard instrument after suspected Creutzfeldt-Jakob Disease (CJD) exposure; the
Integra® Female Catheters and Walther Catheter-Dilators have not been validated
to withstand the chemical and thermal exposures recommended to
eradicate prions.
• Read the Instructions for Use and keep them in a safe place.
• Use the product only in accordance with its intended use, see
Indications for Use.
• Use of an instrument for a task other than that for which it is intended could
result in a damaged or broken instrument, or one which provides an
unsatisfactory performance.
• Instruments should be handled and operated by personnel completely familiar
with their use, assembly and disassembly.
• Instruments must be rendered safe for handling, inspection and assembly by
wearing appropriate personal protection equipment (PPE) as promulgated by
OSHA and AORN.
• Inappropriate use of instruments will lead to damage that is usually not repairable.
• Instruments must be thoroughly inspected upon receipt and prior to use to assure
proper functioning. Failure to make a complete inspection to assure proper
operation and function of instrument may result in unsatisfactory performance.
• Integra® Female Catheters and Walther Catheter-Dilators are supplied non-sterile
and must be pre-cleaned, cleaned, visually examined and sterilized prior to use.
Please see pre-cleaning, cleaning, visual examination, and sterilization
procedures below.
• Prior to each use, inspect the product for: loose, bent, broken, cracked, worn, or
fractured components.
• Do not use the product if it is damaged or defective.
Integra
®
Female Catheters and
Walther Catheter-Dilators
Rx Only CAUTION: Federal (USA) law restricts this device to sale by or on the order of a surgeon.
Instructions for Use/English
• Replace any damaged components immediately with original spare parts.
• Store products in a dry, clean and safe place.
Pre-Cleaning, Cleaning, and Sterilization Procedures
Before using the instruments pre-clean, clean (manual or automated), dry, visually
examine, and sterilize following the procedures below.
Personnel should follow accepted guidelines as recommended in ANSI/AAMI
ST79:2006, A1:2008, A2:2009 -Comprehensive guide to steam sterilization and
sterility assurance in health care facilities.
Pre-Cleaning
Pre-cleaning should occur as soon as possible after instrumentation is used.
1. Remove gross debris from surgical instruments with a sponge and sterile water
after use to prevent drying of blood and body fluids on the instruments.
2. Place instruments in an instrument tray/container and saturate all surfaces for five
(5) minutes with a pre-cleaning enzymatic product such as Miltex Instrument Prep
Enzyme Foam.
• Other foam, spray or gel products, intended for use with surgical instruments,
are available to keep soil moist but have not been validated for use with
Integra® Female Catheters and Walther Catheter-Dilators.
Cleaning:
Cleaning should occur as soon as possible after instrumentation is pre-cleaned.
After performing steps 1-6 below, perform either “Manual Cleaning” or
“Automated Cleaning”.
1. Rinse instrument with deionized water for two (2) minutes.
2. Use a clean, soft bristled brush to clean and remove visible soil from the lumens
and other surfaces of the instruments.
3. Vigorously flush lumens with 50ml of deionized water using a syringe or
similar apparatus.
4. Prepare Miltex® EZ-Zyme® All-Purpose Enzyme Cleaner solution per manufacturer’s
recommendations/instructions for correct dilution and temperature.
5. Immerse fully opened instruments in the prepared Miltex EZ-Zyme All-Purpose
Enzyme Cleaner solution for ten (10) minutes.
6. Rinse instrument and flush lumens with deionized water for two (2) minutes.
7. Proceed either to “Manual Cleaning” or “Automated Cleaning” procedures below:
Manual Cleaning
1. Prepare Miltex EZ-Zyme All-Purpose Enzyme Cleaner solution per manufacturer’s
recommendations/instructions for correct dilution and temperature.
• Other cleaning reagents/detergents are available but have not been validated
for use with Integra® Female Catheters and Walther Catheter-Dilators.
2. Using a small, clean hand-held brush, remove soil from all surfaces of instrument
while fully immersed in solution.
3. Use a soft bristled brush to clean the lumens.
• Never use steel wool, wire brushes, scalpel blades or highly abrasive detergent or
cleansers to remove soil as these will damage the instruments’ protective surface
and lead to corrosion.
4. Vigorously flush channels with 50 ml of tap water or distilled water. Rinse
thoroughly and aggressively for two (2) minutes with tap water or distilled
water distilled water.
5. Using an ultrasonic (e.g., VWR Model 750D, Aquasonic 750HT, or Branson 8200)
sonicate instruments for ten (10) minutes.
• Prepare Miltex EZ-Zyme All-Purpose Enzyme Cleaner solution per manufacturer’s
recommendations/instructions for correct dilution and temperature and place in
an ultrasonic (e.g., VWR Model 750D, Aquasonic 750HT, or Branson 8200).
• Condition (de-gas) ultrasonic cleaner for 5 minutes.
• Place instruments in the ultrasonic cleaner manufacturer’s instrument tray.
• Ensure instruments are in the open position.
• Keep different metal types separated (i.e., separate stainless steel from
non-anodized aluminum, brass, copper and chrome-plating to avoid possible
transfer of one metal plating to another).
• Place tray with the instruments into the ultrasonic cleaner.
• Sonicate instruments for ten (10) minutes.
• Other ultrasonic cleaners may be available but have not been validated for use
with Integra® Female Catheters and Walther Catheter-Dilators.
6. Remove instruments from sonicator and rinse for two (2) minutes with
deionized water.
7. Visually inspect instrument for cleanliness and ensure all parts are in proper
working order.
8. Dry the components with a clean, dry, lint-free wipe or cloth. Force air through
the lumen using filtered air or a syringe until excess water can no longer be
visually seen.
• Other drying methods may be available but have not been validated for use with
Integra® Female Catheters and Walther Catheter-Dilators.
9. Inspect instruments for visual dryness.
Automated Cleaning
1. Place instruments in a wire basket.
• Ensure instruments are in the open position.
• Keep different metal types separated (i.e., separate stainless steel from
non-anodized aluminum, brass, copper and chrome-plating to avoid possible
transfer of one metal plating to another).
2. Place wire baskets in an automatic washer-sterilizer or washer-disinfector, such as
a Steris Reliance Genfore washer/disinfector. Using the parameters/detergents
listed in the table below clean the instruments.
• Other automatic washer-sterilizer or washer-disinfector specific parameters may
be available but have not been validated for use with Integra® Female Catheters
and Walther Catheter-Dilators.
3. Remove instruments from automatic washer.
4. Visually inspect instruments for cleanliness and ensure all parts are in proper
working order.
5. Visually inspect instruments to ensure they are dry.
Treatment Time (mm:ss) Temperature Cleaner
Presoak 02:00 Cold (20.7°C – 32.7°C) Water
Enzymatic
Wash 04:00 Hot (39.0°C – 47.7°C) Steris Prolystica®
2x Concentrate
Enzymatic Cleaner
and Presoak (1/8 oz.
per gallon)
Wash
(Cleaning) 02:00 55°C (131°F) Steris Prolystica®
2x Concentrate
Enzymatic Cleaner
and Presoak (1/8 oz.
per gallon)
Rinse 02:00 70°C (158°F) Water
Dry 15:00 80°C (176°F) N/A