Manufacturer's Limited Warranty; Non-Standard Symbols - Spectranetics SLS II Mode D'emploi

5. Insert and lock a locking stylet into the lead. Alternatively, a length of suture material approximately 60 cm long may be attached to the proximal end of the lead to act as a traction device.
6. Fill a sterile syringe with 10 cc of saline solution. Inject the saline into the inner lumen of the Laser Sheath. Using another 10 cc of saline, moisten the outer jacket of the laser sheath.
7. Place an outer sheath over the laser sheath.
8. Using a "Fish Tape" device, thread the handle of the traction device through the inner lumen of the Laser Sheath. Remove the "Fish Tape" after the traction device handle emerges from the proximal
end of the laser sheath. Thread the proximal end of the lead into the inner lumen of the laser sheath.
9. Extraction technique:
PRECAUTION: When advancing a Laser Sheath or outer sheath around a bend, keep the point of the sheath's beveled tip oriented toward the inside of the bend.
PRECAUTION: As in all extraction procedures using a laser sheath, but particularly when removing dual coil ICD leads, maintain sturdy traction and a stable "rail" position with the lead while keeping
coaxial alignment of the laser sheath and the bevel on the inside curvature of the SVC.
PRECAUTION: Before entering the SVC, stop to ensure sturdy traction and a stable "rail" are maintained.
a. Using an "inchworm" technique, alternately advance the outer sheath and the laser sheath over the lead.
b. Use the following guidelines to determine if a tissue obstruction is met:
• The laser sheath will not advance into the vein.
• The laser sheath bows outward slightly when longitudinal pressure is applied.
• Fluoroscopy shows that the sheath tip does not advance relative to the lead body.
• Fluoroscopy shows that the laser sheath tip is not caught on a lead electrode, a lead bend, or another lead.
c. When an obstruction is met and the laser sheath cannot be advanced:
• Use orthogonal uoroscopic views to ensure that the tip of the laser sheath is aligned with the longitudinal axis of the lead.
• Retract the outer sheath so that its distal end does not overlap the tip of the Laser Sheath. Press the laser sheath gently into the obstructing tissue.
• Place the laser in READY mode. Depress the foot switch, activating the laser. While the laser is ring, use gentle pressure on the laser sheath to advance the device approximately
1 mm per second while applying equal and opposite traction to the traction device. If the laser sheath breaks through the obstruction during lasing, release the foot switch.
PRECAUTION: Advancing the laser sheath through moderately calci ed tissue may require more pulses of laser energy than through brous scar overgrowth. Advance the outer sheath to the new
position of the laser sheath.
PRECAUTION: Stop if not able to advance the laser sheath. Be prepared to upsize to a larger laser sheath, move to another lead, try a femoral approach or consider an open procedure. Also consider
abandoning the procedure by leaving the lead in place and refer to a more experienced center.
d. If the traction device unlocks its grip on the lead, it is necessary to remove the laser sheath and outer sheath, and apply a new traction device, before proceeding again with the laser sheath.
e. Advance the outer sheath and laser sheath to the desired location on the lead, as described in 9 (a-c) above. Do not advance the laser sheath any closer than 1 cm from the lead tip. Do not
lase at the myocardium to free the lead tip.
f. If necessary, use countertraction, using the outer sheath and the traction device, to free the lead tip from the heart wall.
10. Withdrawal of the laser sheath and outer sheath can be accomplished at any time during the procedure. If the lead is free, it should be drawn into the laser sheath before the lead, the laser sheath,
and the outer sheath are removed from the body.
PRECAUTION: If the Laser Sheath is removed from the body for any reason, thoroughly clean the device shaft, inner lumen and tip with saline to remove particles and prevent blood from sticking.
PRECAUTION: If the Laser Sheath becomes kinked or damaged during use as evidenced by uoroscopy, it is recommended to discontinue use of the device. Weigh the relative risks and bene ts of device
removal versus continued use.
12.3 Physician Training
• Physician training in use of the Laser Sheath and CVX-300
• Classroom training in laser safety and physics;
• A didactic presentation of laser operation followed by a demonstration of the laser system;
• Hands-on training in the use of the laser system in lead removal;
• Observation of the removal of at least two leads with the Laser Sheath performed by an experienced Laser Sheath user;
• Removal of at least two leads in the presence of a second physician experienced in lead removal techniques and a fully trained Spectranetics representative.
• HRS and EHRA recommendations for complication management
3 4

13. Manufacturer's Limited Warranty

Manufacturer warrants that the SLS II is free from defects in material and workmanship when used by the stated "Use By" date. Manufacturer's liability under this warranty is limited to replacement or
refund of the purchase price of any defective unit of the SLS II. Manufacturer will not be liable for any incidental, special, or consequential damages resulting from use of the SLS II. Damage to the SLS
II 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 the Manufacturer.
This limited warranty covers only the SLS II. Information on Manufacturer's warranty relating to the CVX-300™ Excimer Laser System or Philips Laser System can be found in the documentation relating
to that system.

14. Non-Standard Symbols

Importer
Tip Inner Diameter
Size
Outer Sheaths
Working Length
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
3 Wilko B.L., et al. Transvenous Lead Extraction: Heart Rhythm Society Expert Consensus on Facilities, Training, Indications, and Patient Management. Heart Rhythm. July 2009.
4 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.
P002674-12 21OCT20 (2020-10-21)
SLS™II Laser Sheath
Excimer Laser System or Philips Laser System should include:
™
Each Kit Includes
Tip Outer Diameter
Laser Sheath
Fish Tape
Quantity
Instructions for Use
English / English
QTY
7