Spectranetics TightRail Mini 540-009 Instrucciones De Uso página 6

• When the TightRail Mini sheath breaks through the obstruction you may stop activating the dilating mechanism while advancing to the next point of
binding tissue.
• Monitor all device maneuvers and activations by fluoroscopy.
• If needed, advance the outer sheath to the new position of the TightRail Mini sheath.
e. If the traction device unlocks its grip on the lead, it is necessary to remove the TightRail Mini sheath and outer sheath, and apply a new traction device,
before proceeding again with the TightRail Mini sheath.
f. After the resistance has been relieved, advance the TightRail Mini sheath and optional outer sheath to the next desired location or point of resistance on
the lead and repeat the process as described in 11 (a-d) above.
12. Withdrawal of the TightRail Mini sheath and outer sheath can be accomplished at any time during the procedure. If the lead is free, it should be drawn into the
TightRail Mini sheath before the lead, the TightRail Mini sheath, and the outer sheath are removed from the body.
13. If the lead is not removed from the vessel with gentle pulling and use of the TightRail Mini sheath, exchange the TightRail Mini sheath for an appropriately sized
full-length sheath to complete the extraction.
14. To retain venous access for re-implant, keep the outer sheath in place for guidewire insertion when removing lead and TightRail Mini sheath. Remove the outer
sheath from the body after guidewire is inserted. If an outer sheath is not used, remove the lead through the TightRail Mini sheath, keeping the TightRail Mini
sheath in place for guidewire insertion. Remove the TightRail Mini sheath device from the body after guidewire is inserted.
15. At the completion of the extraction, withdraw the TightRail Mini sheath and outer sheath from the patient and inspect the TightRail Mini sheath for damage
prior to any additional use.
16. Dispose of the used products according to local biological handling and disposal procedures.
References
1. Wilkoff B.L., et al. Transvenous Lead Extraction: Heart Rhythm Society Expert Consensus on Facilities, Training, Indications, and Patient Management. Heart
Rhythm. July 2009.
2. Deharo J.C., et al. Pathways for training and accreditation for transvenous lead extraction: a European Heart Rhythm Association position paper. Europace
(2012) 14, 124-134
3. Verma A, Wilkoff BL. Intravascular pacemaker and defibrillator lead extraction: A state-of-the-art review. Heart Rhythm, Vol. 1, No. 6, December 2004; 739-745.
4. Smith HJ, et al. Five-years experience with intravascular lead extraction. PACE 1994; 17:2016-2020.
5. Byrd CL, et al. Lead extraction: indications and techniques. Cardiol Clin 1992: 10:735-748.
6. Byrd CL, et al. Intravascular techniques for extraction of permanent pacemaker leads. J Thorac Cardiovasc Surg 1991:101:989-997.
7. Byrd CL, et al. Intravascular lead extraction using Locking Stylets and sheaths. PACE 1990: 13:1871-1875.
11. MANUFACTURER'S LIMITED WARRANTY
Manufacturer warrants that the TightRail Mini sheath is free from defects in material and workmanship when used by the stated "Use By" date and when package
is unopened and undamaged immediately before use. Manufacturer's liability under this warranty is limited to replacement or refund of the purchase price of any
defective TightRail Mini sheath. Manufacturer will not be liable for any incidental, special, or consequential damages resulting from use of the TightRail Mini sheath.
Damage to the TightRail Mini sheath caused by misuse, alteration, improper storage or handling, or any other failure to follow these Instructions for Use will void this
limited warranty. THIS LIMITED WARRANTY IS EXPRESSLY IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING THE IMPLIED WARRANTY
OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. No person or entity, including any authorized representative or reseller of Manufacturer, has
the authority to extend or expand this limited warranty and any purported attempt to do so will not be enforceable against Manufacturer.
12. NON-STANDARD SYMBOLOGY
Importer
Quantity
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
P008138-A 09SEP21 (2021-09-09)
TightRail Mini
Rotating Dilator Sheath
Tip Inner Diameter
QTY
Device Outer Diameter
TM
Instructions for Use
Working Length
Size
English / English
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