Product Description; Indications For Use - Halyard SMART-FOLD H450 Bedienungsanleitung

Single Use Only, Disposable

Product Description

HALYARD* SMART-FOLD* Sterilisation Wrap is supplied in bulk to the customer as pre-shaped sterilisation wrap which is then used to wrap a medical device or a
collection of medical devices for sterilisation. The SMART-FOLD* Sterilisation Wrap is comprised of two pre-shaped sheets of HALYARD* Sequential Sterilisation Wrap.
Each sheet is composed of a three-layer SMS (spunbond-meltblown-spunbond) polypropylene fabric treated with an antistatic treatment.
The SMART-FOLD* Sterilisation Wrap features reinforcement zones, a medical device placement reference line, a white inner layer, side-tabs with closure strips and pull-
tabs which allow for aseptic presentation of the sterilised medical device. The white sheet has the same material composition but contains no blue pigment.
SMART-FOLD* Sterilisation Wrap is available in various sizes including those offered in Table 1.
Table 1. SMART-FOLD* H450 and H650 Dimensional Specifications
Dimensions
55 cm x 114 cm (22 in x 45 in)
71 cm x 116 cm (28 in x 46 in)
101 cm x 119 cm (40 in x 47 in)
101cm x 139 cm (40 in x 55 in)
121 cm x 154 cm (48 in x 61 in)
(All grades may not be available in all regions.)

Indications for Use

SMART-FOLD* Sterilisation Wrap is intended to be used to enclose another medical device that is to be sterilised by a health care provider using:
• Pre-vacuum steam at 132°C/270°F for 4 minutes, 134°C/273°F for 3 minutes and 135°C/275°F for 30 minutes. The wrap was validated for a dry time of
30 minutes.
• 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 55ºC/131°F and 40% – 80% relative humidity for 60 minutes. The wrap was validated for
aeration times for EO sterilisation of 8 hours at 55°C/131°F or 12 hours at 43.3°C/110°F.
• Advanced Sterilisation Products STERRAD® Sterilisation System (See Appendix)
• STERRAD® 100S
• STERRAD® NX (Standard Cycle, Advanced Cycle)
• STERRAD® NX with ALLClear® Technology (Standard Cycle, Advanced Cycle)
• STERRAD® 100NX (Standard, Flex, EXPRESS, and Duo Cycles)
• STERRAD® 100NX with ALLClear® Technology (Standard, Flex, EXPRESS, and Duo Cycles)
• STERIS V-PRO® Low Temperature Sterilisation Systems. The wrap was validated to be effectively aerated during the pre-programmed cycles.
• 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® maX 2 (Lumen, Non-Lumen and Flexible Cycle)
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.
Warnings
• Do not use wrap in dry heat or radiation sterilisation methods.
• Do not use wrap if damage or extraneous matter is detected prior to use.
• Do not use wrapped contents if package is torn, wet, or compressed.
• Do not reuse. This wrap is single use only.
• Halyard does not endorse the reuse (resterilisation) of its sterilisation wraps, as product performance and degradation limits following reuse have not been
established or validated.
Precautions
• Do not open case with a sharp knife. Knives can easily cut the product.
• Prior to use, assure that all medical devices intended to be sterilized while wrapped within the SMART-FOLD* Sterilisation Wrap are compatible with and
sterilizable by the sterilisation modality and cycle listed in the Indications for Use in these instructions. Consult the sterilisation instructions for all devices intended
for sterilisation. Some medical devices, regardless of the sterilisation method and sterilisation package/container used, may require special consideration in packing
configurations to ensure sterilisation (refer to ANSI/AAMI ST79 Comprehensive Guide to Steam Sterilisation and Sterility Assurance in Health Care Facilities).
• Do not use in the presence of flammable anesthesia. The wrap is non-conductive.
• If sterilisation is performed by an outside contract facility, O&M Halyard recommends that the wrapped devices should be protected from contamination by an
additional covering.
• Stacking heavy sterilized trays during storage can lead to damage of the wrap due to undue pressure from the excess weight.
Instructions for Use
The SMART-FOLD* Sterilisation Wrap should be used in accordance with the preparation and sterilisation chamber loading recommendations of the following standards:
• BS EN ISO 11607-1 Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems.
• EN 868-2 Packaging for terminally sterilised medical devices, sterilisation wrap, requirements and test methods.
• BS EN ISO 11607-2 Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes.
• EN ISO TS 16775 Packaging for terminally sterilized medical devices – Guidance on the application of ISO 11607-1 and ISO 11607-2.
• BS EN ISO 10993-7 Biological evaluation of medical devices. Ethylene oxide sterilization residuals.
• EN 13060 Small steam sterilisers.
H450
x
x
x
x
x
H650
x
x
x
x
x
LBL-00013 Rev. 1