Manufacturer's Limited Warranty; Non-Standard Symbology - Spectranetics Turbo-Power Gebrauchsanweisung

NOTE: Turbo-Power System rotate buttons may be used during the procedure to accomplish the following:
a. Orient the distal tip prior to lasing (Step 11)
b. Momentarily rotate the distal tip or continuously rotate the distal tip while lasing and advancing the catheter (Step 12)
11. If orientation of the distal tip is deemed necessary prior to advancement of the Turbo-Power System, press ">" rotate button to rotate the
distal tip clockwise and "<" rotate button to rotate the distal tip counter-clockwise until desired orientation is achieved.
NOTE: The MDU allows a maximum of 6 consecutive rotations in each direction from home position as indicated by the LEDs. Following 6 consecutive
rotations in one direction rotate the distal tip in the other direction 6 consecutive times to bring tip position to the center.
12. If momentary or continuous rotation is deemed necessary while advancing the Turbo-Power System, press ">" and/or "<" rotate button to
momentarily rotate the distal tip clockwise and/or counterclockwise respectively, or press both buttons simultaneously to continuously
rotate the distal tip.
NOTE: During continuous rotation, the distal tip changes direction from clockwise to counter-clockwise when it reaches the guardrail at either end.
The direction of distal tip movement is indicated by the LEDs.
13. Continue lasing while advancing the Turbo-Power over the guidewire at less than 1mm per second in 20 second increments until the
obstruction has been crossed or an adequate channel has been created. Continue general operation.
14. Release the footswitch to deactivate the laser system. NOTE: The laser system will continuously deliver energy as long as the footswitch is
depressed. The length of the laser train is controlled by the operator. It is generally recommended not to exceed 20 seconds of continuous
lasing.
NOTE: There is no need to remove the laser catheter from the patient in order to increase or decrease either the uence or pulse repetition rate as the laser
catheter was previously calibrated. Refer to the CVX-300™ Excimer Laser Operator's Manual or the Philips Laser System Operator's Manual.
15. Retract the catheter to the proximal cap of the lesion.
16. Additional passes may be completed by repeating steps 10-14 for maximum debulking with or without distal tip rotation.
NOTE: If at any point in the procedure the error light activates, discontinue use of the device
17. Withdraw the Turbo-Power System from the patient while maintaining distal guidewire position.
18. Following laser recanalization, perform follow-up angiography and balloon angioplasty, if needed.
19. All equipment should be disposed in accordance with hospital biohazard waste and local authority regulations.
Step-by-Step Method for Total Occlusion
a. Depress the footswitch, activating the laser system, and slowly, less than 1mm per second, advance the laser catheter 2-3 mm into
the total occlusion without distal tip rotation, allowing the laser energy to remove the desired material. Release the footswitch to
deactivate the laser system.
b. Advance the guidewire beyond the distal tip of the laser catheter further into the occlusion, a few millimeters, and reactivate the laser
as described in Step a above.
c. Continue in this step-by-step manner where the guidewire and then the laser catheter are advanced and activated (mm by mm) until
the catheter reaches the last 3-5 mm of the occlusion.
d. Cross the last 3-5 mm of the occlusion and enter the patent distal vessel with the guidewire rst, followed by the activated laser
catheter over-the-wire.
e. Leaving the guidewire in position, pull back the laser catheter and inject contrast medium through the guiding catheter and examine
the lesion via uoroscopy.
f. Additional laser passes may be performed over-the-wire to achieve greater debulking of the lesion according to steps 10-14 above
with or without distal tip rotation.
g. If resistance to catheter advancement is met (such as calcium), immediately stop lasing by releasing the footswitch to deactivate the
laser system. The uence and repetition rates can be adjusted in order to advance.
CAUTION: To avoid the potential of heat build-up, the catheter must be advanced while lasing.
Saline Infusion Protocol
Note: Use of two operators is recommended for this technique. It is recommended that the primary physician-operator advance the laser catheter and
operate the laser system foot pedal. A scrub assistant should manage the saline infusion and (if appropriate) depress the uoroscopy pedal.
a. Before the laser procedure, obtain a 500 mL bag of 0.9% normal saline (NaCl). It is not necessary to add heparin or potassium to the
saline solution. Connect the bag of saline to a sterile intravenous line and terminate the line at a port on a triple manifold.
b. Under uoroscopic guidance, advance the laser catheter into contact with the lesion.
c. If necessary, inject contrast to help position the tip of the laser catheter. If contrast appears to have become entrapped between the
laser catheter tip and the lesion, the laser catheter may be retracted slightly (1-2 mm) to allow antegrade ow and contrast removal
while ushing the system with saline. However, before lasing, ensure that the laser catheter tip is in contact with the lesion.
d. If using a control syringe, expel any residual contrast back into the contrast bottle. Clear the triple manifold of contrast by drawing
up saline through the manifold.
e. Remove the original control syringe from the manifold and replace it with a fresh luer-lock control syringe. This new control syringe
should be primed with saline prior to connection to reduce the chance for introducing air bubbles.
f. Flush all traces of blood and contrast from the manifold, connector tubing, y-connector, and introducer sheath or guide catheter,
with at least 20-30 mL of saline.
g. Under uoroscopy, con rm that the tip of the laser catheter is in contact with the lesion (advance the laser catheter if necessary),
but do not inject contrast. When the primary operator indicates that he/she is ready to activate the laser system, the scrub assistant
should turn the manifold stopcock o to pressure and inject 10 mL of saline at a rate of 2-3 mL/second through the sheath and/or at a
rate no greater than 0.5 mL/second through the guidewire lumen. This bolus injection is to displace and/or dilute blood down to the
level of the capillaries and limit back- bleeding of blood into the laser ablation eld.
h. After the injection of the initial 10 mL bolus and without stopping the motion of injection, the scrub assistant maintain a rate of
injection of 2-3 mL/second through the sheath. In addition, saline can be injected through the guidewire lumen at a rate no greater
than 0.5 mL/second, or a pressure no greater than 131 psi. This portion of the saline infusion is to displace and/or dilute the antegrade
blood ow entering the laser ablation eld. At the instant the scrub assistant initiates this saline infusion, the primary operator should
activate the laser system by depressing the foot pedal and begin a lasing sequence.
i. The length of the laser train is controlled by the operator. It is generally recommended not to exceed 20 seconds of continuous lasing.
Saline must be infused throughout the entire lasing process.
j. Terminate the saline injection at the end of the lasing train.
k. Each subsequent laser train should be preceded by a bolus of saline and performed with continuous saline infusion as described in
steps i-j.
l. If contrast is used to assess treatment results during the course of a laser treatment, repeat steps c-f prior to reactivation of the laser
system (before activating the laser repeat steps g-j).
Note: Depending on which approach is used, antegrade or contralateral, saline can be administered through the sheath (antegrade approach)
or laser catheter inner lumen (contralateral approach). When the contralateral approach is used, smaller diameter guidewires are suggested to
allow adequate saline infusion at the treatment site.
11.3
Return Product
In the event that the device is to be returned once opened because of a complaint or any allegation of de ciency with the product's performance,
please contact Post Market Surveillance for the procedure to return contaminated products at the following contacts: Phone: +31 33 43 47 050
or +1-888-341-0035 Email: complaints@spectranetics.com.
P015612-03 13APR21 (2021-04-13)
Turbo-Power™ Laser Atherectomy Catheter

12. MANUFACTURER'S LIMITED WARRANTY

Manufacturer warrants that the Turbo-Power System 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 Turbo-Power System.
Manufacturer will not be liable for any incidental, special, or consequential damages resulting from use of the Turbo-Power System. Damage to the
Turbo-Power System 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 Turbo-Power System. 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.

13. NON-STANDARD SYMBOLOGY

Patent:
www.spnc.com/patents
Caution: Federal (USA) law restricts this device to sale by or on the order of a
physician.
h
Catalog Number
L
Do not use if package is damaged
95<
m
Humidity Limitation
5<
p
Keep Dry
Working Length
Max Shaft Diameter
Max Tip Diameter
Y
MDU Error Status
(triangle has yellow
background)
Home-
Location of Proximal end
of catheter
QTY
Quantity
Hydrophilic Coating
Importer
Protected against vertically falling water drops when enclosure tilted up to 15°
Interference may occur in the vicinity of other equipment marked with the following symbol
Instructions for Use
English / English
IFU:
www.spnc.com/IFUlibrary
g
Lot Number
111kPa
n
Atmospheric Pressure
Limitation
11kPa
60 º C / 140 º F
l
Temperature Limit
0 º C / 32 º F
Guidewire Compatibility
Sheath Compatibility
MDU Power On Status
< >
Jog-
Directional Selection
of Proximal Rotation
De brillation-Proof
Type CF Applied Part
Energy Range (mJ) at 45 Fluence 36.5-44.6 mJ (7F)
Energy Range (mJ) at 45 Fluence 20.8-25.0 mJ (6F)
OTW
Over the Wire
IPX2
8