Section 4 Additional Information; Use Of The Thoraflex™ Hybrid Device Perfusion Side Branch; Origin Of Gelatin; Sterilisation - Vascutek Thoraflex THP2224X100B Instrucciones De Uso

SECTION 4 ADDITIONAL INFORMATION

SECTION 4.1 USE OF THE THORAFLEX™ HYBRID DEVICE PERFUSION SIDE BRANCH
Initiation of Antegrade Perfusion: The bypass catheter should be placed in the side branch of the Plexus 4 or
Ante-Flo device and securely attached.
Completion of Antegrade Perfusion: Once bypass is complete, the cannula side branch of the Plexus 4 or Ante-Flo
device should be cut off and the remaining stump over-sewn using standard surgical technique.
SECTION 4.2 ORIGIN OF GELATIN
Vascutek uses gelatin manufactured from animals native to, and exclusively raised in Australia. Australia is
classified as a negligible BSE risk country according to the OIE categorisation (adopted by the European Union
with the Regulation (EC) N°722/2007).
SECTION 4.3 STERILISATION
These systems have been sterilised using Ethylene Oxide and are supplied sterile. The Tyvek® seal on both
intermediate and inner pouches must be intact. Any damage to the pouches renders the system non-sterile.
Note: In the event of damage to the primary packaging, the product must not be used and should be returned
immediately to the supplier.
CAUTION: THE THORAFLEX™ HYBRID SYSTEM MUST NOT BE RE-STERILISED.
SECTION 4.4 PACKAGING
Tyvek® pouches are enclosed in a foil pouch that serves as a vapour barrier and preserves optimal system
characteristics. A sachet containing a desiccant is included to aid this purpose.
Note: The foil pouch and outer Tyvek® pouch are not sterile. Only the innermost pouch and tray can be introduced
to the sterile field.
SECTION 4.5 ADDITIONAL LABELS
Additional labels are enclosed for use on patient records.
SECTION 4.6 DISPOSAL OF THE THORAFLEX™ HYBRID DELIVERY SYSTEM
At the end of the procedure care must be taken to ensure safe disposal of the Thoraflex™ Hybrid Delivery System.
Each operating team must ensure local and national regulatory requirements for the disposal of contaminated
clinical waste products are adhered to.
SECTION 4.7 RETURNING A THORAFLEX™ HYBRID DELIVERY SYSTEM OR DEVICE
All explanted delivery systems/devices should be returned to Vascutek for analysis as soon as possible. In the
event of a used delivery system/device needing to be returned to Vascutek, it is a requirement to have the
delivery system/device, and any other items used in the procedure to be returned in an explants box which
can be obtained from Vascutek's Quality Assurance Department. If required, explant kits can be requested at
complaints@vascutek.com or through your local distributor and will be provided for the retrieval and preservation
of the explanted device and/or delivery system or other components for transit to Vascutek.
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