Warnings; Universal Precautions; Points Of Use; Cleaning - Summit Medical INSTRUSAFE Gebrauchsanweisung

WARNINGS

For aluminum InstruSafe Systems, use only neutral (6.0 – 8.5) pH 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.

UNIVERSAL PRECAUTIONS

• Personnel should wear all personal protective clothing and equipment as required by their employers / 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 soil with disposable cloth/paper wipe.

CLEANING

Equipment: Enzymatic detergent, brush and running water. Use only neutral (6.0 – 8.5) pH 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.
Manual Gross Decontamination:
1) 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.
2) Rinse thoroughly for a minimum of 1 minute with clean water to remove all detergent. See rinsing instruction on the
detergent label.
Ultrasonic clean:
Prepare enzyme wash in an ultrasonic cleaning unit. Place a single, cassette in the detergent and run for a minimum of ten minutes.
Rinse for a minimum of 2 minutes with cold tap water. Visually inspect cassette for contaminates. Repeat the cycle if necessary to
remove visible contamination.
Automated washer:
The InstruSafe Instrument Protection Systems are validated for the automatic wash system cycles listed below in Table 1.
Table 1.
CYCLE
Pre-wash 1 & 2
Enzyme Wash :
Wash 1 :
Rinse 1 & 2

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
Note : Clean and inspect cassettes according to the instructions provided
prior to placing into service.
WATER TEMP. CLEANING PROCESS
Cold Tap Water Re-circulation Time : 2 minutes
Hot Tap Water Soaking Time : 4 minutes
Heated at 65.5°C Re-circulation Time : 15 minutes
Hot Tap Water Re-circulation Time : 5 minutes
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 and additional automatic cycles prior to
sending to sterilization.
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