Case Medical SteriTite Bedienungsanleitung Seite 5

SteriTite® Containers and MediTray® products have FDA 510k as well as CE
mark. The FDA 510k clearance demonstrates that the device is safe and
E effective for its intended use. The CE marking certifies that the product has
met EU health, safety, and environmental standards and guidelines. All
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SteriTite® Containers display a unique device identification (UDI) barcode
used to mark and identify medical devices within the healthcare supply chain.
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The UDI supports patient safety and supply chain security.
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The following instructions for use provide guidance for proper care, handling, and processing of medical
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devices when SteriTite® Containers and MediTray® products are used.
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SteriTite® and MediTray® Decontamination
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The hospital is responsible for in-house procedures for the disassembly, reassembly, inspection and
packaging of instrument sets including Container systems after they are thoroughly cleaned in a manner
that will assure sterilant penetration and adequate drying. Prior to using the SteriTite® and MediTray®
products follow the cleaning procedures in this IFU and perform a visual inspection of all parts. Case Medical
recommends that Containers are reprocessed as soon as possible following use. Excess soil should be
removed after use by rinsing or wiping the device prior to the cleaning procedure. Personal Protective
Equipment (PPE) should be worn when handling or working with contaminated or potentially contaminated
materials, devices and equipment. PPE includes gown, mask, goggles or face shield, gloves and shoe covers.
Thoroughly clean and decontaminate MediTray® products prior to first use and after each use with
contaminated instruments (prior to sterilization). Details of proper cleaning procedures are as follows:
1. Disassemble all components. Unlatch and remove the lid of the SteriTite®
rigid container. Remove filter retention plates from lid and base by turning
the handle of the locking mechanism clockwise. Do not remove the gasket
for the cleaning procedure. Remove filters and all other disposables and
discard.
2. Remove the tray of contaminated instruments and prepare the
instruments for decontamination following the recommendations of the instrument manufacturer.
3. Clean your MediTray® and SteriTite® products after each use with a pH neutral/enzymatic detergent and
a soft, lint free cloth. Do not use abrasive cleaners, abrasive pads, or metal brushes. MediTray® baskets and
trays can also be cleaned in an automatic washer. When using an automated washer, place filter retention
plates in an instrument basket for cleaning.
Manual Cleaning:
SteriTite® Containers may be cleaned manually with a soft lint free cloth and
a pH neutral detergent. Always follow with a thorough rinse to remove
detergent residue. Use a soft lint free cloth to dry all components of the
container. Avoid water collection by washing and drying the Container
upside-down.
Recommendation: Case Solutions® and SuperNova® multi-enzymatic cleaners and detergents are ideal for
cleaning medical devices and sterilization containers. In addition, single use enzymatic towelettes such as
Penta Wipes can be used to decontaminate Container components. Follow with a rinse under the flow of
water. Dry all surfaces and components. Alcohol Wipes can facilitate drying. Case Solutions® and
SuperNova® cleaners, and instrument lubricant are U.S. EPA Safer Choice Awarded.
Automated Cleaning:
SteriTite® Containers may be cleaned in automated washers or cart washers
when pH neutral detergents or enzymatic cleaners are used. Follow the
recommended dosage of the detergent. If an automatic washer is used, secure
all parts to avoid excess movement during cleaning. Make sure the Container
latches are folded inward and the handles are tucked within the racks, so they
don't protrude. Use utility or instrument cycles for automated cleaning in
washer disinfectors and the Container cycle of the cart washer. Always follow
the wash step with a thorough rinse to remove detergent residue.
Caution: Do not use alkaline detergents, acid neutralizers or scratch pads. Caustic detergents will oxidize
the anodized aluminum surface of the Container and create discoloration and corrosion.
Copyright 2020 Case Medical, Inc.®
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IFU-CASETRANS Rev. 004A