Warnings; Points Of Use; Cleaning; Disinfection - Covidien TipVision Instrucciones De Uso

WARNINGS

For aluminum InstruSafe Systems, use only neutral pH (6.0 – 8.5) detergents to avoid damaging the finish. A detergent with a highly
acidic or highly alkaline pH could permanently damage the anodized aluminum finish of the cassette and metal components.
Do not use if package is damaged or unintentionally opened prior to use.
Note:
Clean and inspect cassettes according to the instructions provided prior to placing into service.
UNIVERSAL PRECAUTIONS
Personnel should wear all personal protective clothing and equipment as required by their employer's/department's operating
procedures for the contamination level they will be exposed to.
Keep dissimilar metals separated during sterilization to prevent corrosion.
POINT OF USE
Remove gross soil with disposable cloth/paper wipe. Contaminated components should be kept moist until qualified cleaning processes
can be applied.

CLEANING

Refer to the instrument manufacturer's instructions for use for specific instructions for cleaning the instruments in the cassettes.
Use one of the following validated cleaning options to clean the cassette/tray is recommended.
Use only neutral pH (6.0 – 8.5) solutions, mildly alkaline and free of sodium carbonate to avoid damaging finish for aluminum cassettes.
DO NOT use scouring pads or abrasive cleaners. DO NOT store cassette in liquid.
1. Manual Gross Decontamination:
A. Materials needed: Neutral pH (6.0 – 8.5) enzymatic detergent, soft bristle brush, and running water.
B. Remove all visible soil and contaminates using a soft bristle brush. The entire cassette should be immersed while cleaning, to aid in
the removal of contaminates and to reduce splashing of detergent on personnel, for a minimum of 2 minutes.
C. Rinse thoroughly for a minimum of 1 minute with clean water to remove all detergent. See rinsing instructions on the detergent label.
2. Ultrasonic Clean:
A. Prepare enzyme wash in an ultrasonic cleaning unit.
B. Place a single cassette in the detergent and run for a minimum of ten minutes.
C. Rinse for a minimum of 2 minutes with cold tap water.
D. Visually inspect cassette for contaminates. Repeat the cycle if necessary to remove visible contamination.
3. Automated Washer:
The InstruSafe Instrument Protection Systems have been validated for the automatic wash system cycle listed in Table 1.
Qualification of specific parameters will need to be conducted by the processor.
Table 1
CYCLE WATER TEMPERATURE
Pre-Wash 1 & 2 Cold Tap Water
Enzyme Wash Hot Tap Water
Wash 1 Heated at 150°F (65.5°C)
Rinse 1 & 2 Hot Tap Water

DISINFECTION

InstruSafe systems are intended to be terminally sterilized.

MAINTENANCE, INSPECTION, AND TESTING

InstruSafe systems may be reused until unacceptable deterioration such as corrosion, cracking, rust, peeling, flaking, discoloration, or
mechanical failure occurs.
Signs of Mechanical Failure Include:
Broken or cracked corners or welds
Broken or non-working latches
Missing, torn, or cut silicone inserts
Missing or damaged feet
CLEANING PROCESS
Re-Circulation Time:
2 Minutes
Soaking Time:
4 Minutes
Re-Circulation Time:
15 Minutes
Re-Circulation Time:
5 Minutes
4
Note: After completion of an automatic wash cycle, visually inspect the
InstruSafe System (cassette and accessories) for any remaining
visible soil. All visible soil must be removed by hand cleaning,
brushing, ultrasonic, or additional automatic cycles prior to
sending to sterilization.