Halyard SMART-FOLD H450 Bedienungsanleitung Seite 4

Table 2: Wrap Model Recommendations
SMART-FOLD* Intended Loads
Sterilisation Wrap
Model
H450 Moderate to Heavyweight Package (for example: general
use medical instruments)
H650 Moderate to Heavyweight Package (for example: general
use medical instruments
SMART-FOLD* Intended
Sterilisation Loads
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Wrap Model
H450 Moderate to
Heavyweight
Package
(for example:
general use
medical
instruments)
H650 Moderate to
Heavyweight
Package (for
example:
general use
medical
instruments)
The following loads were used in Sterility Maintenance Validation Studies:
- Pre-vacuum and EO: 4 tray liners (50.8 cm x 63.5 cm) stacked in 25.4 cm x 25.4 cm tray containing 4.99 kg of metal mass
- ASP STERRAD: Aptimax® instrument tray (58.42 cm x 27.94 cm x 10.16 cm.) with Tray Mat, metal and non-metal instruments
- STERIS®: V-PRO® Tray (25.4 cm x 53.34 cm.), 6 surgical forceps, 1 SCBI (self-contained biological indicators), metal mass to reach total weight
Individual results may differ due to factors such as variations in handling practices, wrapping techniques, and folding methods. Results may also differ due to the use of irregularly shaped
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contents, which may put added stress on the wrap. Each healthcare facility should determine for itself which wrap model is most appropriate for each intended use.
Intended loads include: Medical Instruments with and without lumens that include telescopes, endoscopes, cameras, light cords, and general use medical instruments.
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It is recommended to not exceed the maximum wrapped package content weights indicated for each wrap model. Furthermore, it is recommended to not exceed the number, weight, and size of
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individual content types that were validated for the HALYARD* SMART-FOLD* Sterilisation Wrap (i.e., the weight of the metal mass).
The Fast Non-Lumen cycle is intended to sterilize pouched instrument trays only and is therefore not intended to be used for Sterilisation of HALYARD* SMART-FOLD* Sterilisation Wraps.
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Sterilisation
• SMART-FOLD* Sterilisation Wraps are intended for use with the common healthcare Sterilisation parameters listed in the Indications for Use. The Steriliser
manufacturer should be consulted for appropriate Steriliser loading configurations.
• If a Steriliser malfunctions or a cycle is aborted before completion, packages should be re-wrapped prior to being placed into another Sterilisation cycle.
• Results of an Ethylene Oxide Residuals Study are available upon request.
• See Indications for Use for dry times. Note: Many factors can affect drying time other than Sterilisation wrap, including but not limited to: the pack configuration
that is used, cycle variations, the performance of the Steriliser machine, temperature distribution, steam generation, altitude, and ambient temperature and humidity .
Sterilisers vary widely in design and performance characteristics. As recommended in the EN ISO guidelines on steam sterilisation, the user should consult the steriliser
manufacturer's operator manual for specific drying times.
Post-Sterilisation Cooling/Unloading
• Leave wrapped packages on the Steriliser cart untouched until cool to avoid compromising package sterility.
• Visually inspect wrapped items as they are removed from the cart. Items that are torn, wet, or compressed should not be used.
• Packages are ready for immediate unloading if sterilized in the V-PRO® 60, V-PRO® 1, V-PRO® 1 Plus, V-PRO® maX, and V-PRO® maX 2 Low Temperature
Sterilisation Systems.
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2
STERIS® STERIS®
V-PRO® 1 V-PRO® 1
V-PRO® 1 Plus
Plus V-PRO®
V-PRO® maX
maX V-PRO®
V-PRO® maX 2
maX 2 Non-
Lumen Lumen
5.9 kg 5.9 kg
8.9 kg 11.3 kg.–
maX 2,
8.9 kg – maX,
1 and 1 plus
Wrapped Package Content Weights
Pre-vacuum and EO
5.9 kg
11.34 kg
Wrapped Package Content Weights
STERIS® STERIS®
V-PRO® V-PRO® 60
maX Lumen
V-PRO®
maX 2
Flexible
5.9 kg 4.99 kg
10.88 kg 4.99 kg
ASP STERRAD® 100S, NX, NX with ALLClear®
Technology, 100NX, and 100NX with
ALLClear® Technology
4.85 kg
4.85 kg
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STERIS® STERIS®
V-PRO® 60 V-PRO® 60
Non-Lumen Flexible
5.44 kg The validation
studies were
conducted
with one
flexible
endoscope
packaged
into a tray
with silicone
wrap, and
instrument
organizers and
5.44 kg
light cord (if
not integral
to scope) and
no additional
load.
LBL-00013 Rev. 1
3
STERIS®
V-PRO®
maX 2 Fast
Non-
Lumen
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N/A
N/A