Halyard SMART-FOLD H450 Bedienungsanleitung Seite 5

Sterility Maintenance
The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until used.
• Per BS EN ISO 11607-1, Section 8 Packaging system performance and stability under
8.1 General
Sterile Barrier System Integrity Testing (used to establish the capability of the sterile barrier system to maintain sterility) shall be performed after packaging
system performance testing and stability testing on sterilised samples.
Sterile barrier system integrity testing may be performed by testing the integrity of the materials and the integrity of the seals and closures separately.
Note 1: The loss of sterility is regarded as event-related rather than time-related. For additional information, see ISO/TS 16775, ANSI/AAMI ST65, and Reference [21].
The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until used.
• Per ANSI/AAMI ST79, Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities, the shelf life of facility-sterilized items is
event-related and should be based on the quality of the packaging material, the storage conditions, the methods and conditions of transport, and the amount
and conditions of handling. Inventory should be rotated on a "first in, first out" basis. The facility policy should be based on the guidance provided in ANSI/AAMI
ST 79, 11.1.3.
In accordance with industry standards, O&M Halyard has performed a battery of validation testing, including sterilization efficacy, bioaerosol and package maintenance
integrity for HALYARD* Sterilization Wrap used in the sterilization modalities listed in the table below.
Steam Sterilization
Time Point
1-Year
6-Months
Summary of Approved Sterilization Modalities and Packaging Integrity Testing
STERIS V-PRO® Low Temperature Sterilization Systems
1
• STERIS® V-PRO® 60 (Lumen, Non-Lumen and Flexible Cycles)
• STERIS® V-PRO® 1 (Lumen Cycle)
• STERIS® V-PRO® 1 Plus (Lumen and Non-Lumen Cycle)
• STERIS® V-PRO® maX (Lumen, Non-Lumen and Flexible Cycle)
• STERIS® V-PRO® maX2 (Lumen, Non-Lumen and Flexible Cycle)
Advanced Sterilization Products (ASP) STERRAD® Sterilization System Cycles, STERRAD® 50, 100S, and 200
2
• STERRAD® 50, 100S, and 200
• STERRAD® NX®, (Standard Cycle, Advanced Cycle)
• STERRAD® 100NX® (Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle)
• STERRAD® NX® ALLClear® Technology, (Standard Cycle, Advanced Cycle)
• STERRAD® 100NX® ALLClear® Technology, (Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle)
• Additional real time testing supports maintenance of package integrity for 1 year following STERRAD® Sterilisation Systems.
• For 1 year following STERIS® V-PRO® 60, STERIS® V-PRO® maX, STERIS® V-PRO® maX 2, STERIS® V-PRO® 1 and V-PRO® 1 Plus.
The wrap is intended to allow Sterilisation of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until used.
Opening
Inspect package for damage, wetness, or any sign of potential contamination prior to opening and again after opening but before use of contents.
Caution: Do not use contents if these conditions are present, as sterility could be compromised. Reprocess the contents using an unprocessed wrap if any of
these conditions are noted.
1) Break closure mechanism.
Disposal
• Do not re-use.
• Recycle, landfill or incinerate based upon state and local regulations. Recycle non-soiled wraps only.
• The wrap is composed of polypropylene plastic which has a plastics recycling code of "5."
Note: Any serious incident that has occurred in relation to the device should be reported to O&M Halyard at PIQ@hyh.com and the competent authority of the Member State
in which the user is established.
Pre-vac
X
X
Opening a SMART-FOLD* Sterilisation Wrap
2) Unfold first layer.
3) Open sides simultaneously.
V-PRO®
1
X
STERRAD®
2
X
4) Gently lift pull tab labels from
fabric and pull towards you.
LBL-00013 Rev. 1
EO
X