Disclaimer Of Warranty - Medtronic Symplicity Spyral Handbuch

9.4. Achieving adequate wall contact
1. Under fluoroscopic guidance, deploy the spiral by retracting the guidewire into the device until the guidewire tip is approximately 2 cm from the proximal electrode
(electrode 4, Figure 1). Make sure the guidewire does not completely exit the rapid exchange port.
Note: Upon deployment,
■ the distal end of the catheter will retract approximately 6 mm [in a 6 mm-diameter artery]
■
there will be a slight increase in impedance values on electrodes which have come into contact with the renal artery during the deployment
■
some electrodes will likely be in contact with the arterial wall. Observe angiographically.
2. Adequate wall contact is achieved when the following three conditions are met:
a. Deployment of the distal end appears adequate angiographically.
b. Impedance values at each electrode are stable through at least one respiratory cycle.
c. Impedance values are similar for all electrodes.
■
Assessment of adequate wall contact is performed by the physician.
■
If wall contact does not appear to be adequate for any of the three reasons above, it is recommended to slightly adjust electrode positions. To do so, slightly torque the
Symplicity Spyral™ catheter clockwise and/or slightly move the catheter forward. These small maneuvers should improve electrode apposition against the vessel wall.
■
If these small adjustments do not improve wall contact, re-insert the guidewire in the distal end of the catheter, and change the device location in the artery.
3. If one or more electrode(s) is not located within the renal artery, or if any electrode deploys in an unsuitable location (such as the ostium of a branch or an adrenal gland feeder),
deselect (turn off) these electrodes by pressing the electrode number button on the Symplicity G3™ generator touch screen panel. By deselecting these individual electrodes, RF
energy will not be delivered to these electrodes when RF is activated. NOTE: De-selection of electrodes is only possible if electrodes are outside the guide catheter and are displaying
impedance values.
4. If desired, for annotation purposes, the left or right kidney can be selected for the treatment by pressing the icons on the Symplicity G3™ generator touchscreen.
9.5. Performing ablation procedure
1. Once electrodes are well apposed angiographically and impedance value outputs are similar and stable, RF energy can be delivered to the treatment site. This is done by pressing
any of the following: the RF button on the Symplicity G3™ generator front panel or the foot switch. The Symplicity G3™ generator delivers power using an automated algorithm and
will cease power delivery when the treatment is completed. The timer begins counting up and the LED indicator remains blue while RF therapy is being delivered. At any point during
the procedure, delivery of radiofrequency energy can be stopped by pressing the RF button on the Symplicity G3™ generator front panel or depressing the foot switch.
Note: The Symplicity G3™ generator may automatically stop delivering RF energy if certain conditions are detected. A system indicator message or code will appear on the display
(see Symplicity G3™ renal denervation RF generator user manual) and can be cleared by following the appropriate prompt on the display. In case of a hardware fault condition, the
Symplicity G3™ generator will activate a red LED indicator light, emit an audio alert, and display a fault code, if possible (see Symplicity G3™ renal denervation RF generator user
manual).
Note: If the ablation does not initiate due to high-impedance values, try repositioning the dispersive electrode and/or catheter.
2. Once the treatment is completed on one side, re-advance the guidewire carefully out the tip of the Symplicity Spyral™ catheter to straighten the spiral distal end.
Note: If multiple treatments are to be performed in one artery, subsequent treatments should be located at least 5 mm proximal from the original treatment location.
3. Retract the straightened Symplicity Spyral™ catheter into the guide catheter. If treating another vessel, reposition the guide catheter to the next vessel. Repeat procedure for
positioning the Symplicity Spyral™ catheter and deliver treatments.
■
If excessive resistance is felt between the guide catheter and electrodes while retracting, consider adjusting the guide catheter position in the vessel to align the Symplicity
Spyral™ catheter coaxially with the guide catheter tip.
■ Ensure that the guide catheter is flushed with heparinized saline periodically or, at a minimum, between each treatment. Whenever flushing the guide catheter, wait at least
3 seconds to allow the temperature and impedance measurements to stabilize before initiating next treatment.
9.6. Postprocedure
1. Upon completion of all treatments, straighten the distal end by advancing the guidewire and withdraw the straightened catheter completely from the guide catheter.
2. Retract the guidewire and guide catheter from the sheath at the same time.
3. Remove the introducer sheath from the artery and use standard of care procedures to achieve hemostasis at the puncture site.
4. Dispose of the devices in accordance with local hospital, administrative, and/or other government policies.

10. Disclaimer of Warranty

ALTHOUGH THE SYMPLICITY SPYRAL™ MULTI-ELECTRODE RENAL DENERVATION CATHETER, HEREAFTER REFERRED TO AS "PRODUCT," HAS BEEN MANUFACTURED
UNDER CAREFULLY CONTROLLED CONDITIONS, MEDTRONIC AND ITS AFFILIATES, HEREAFTER REFERRED TO AS "MEDTRONIC," HAVE NO CONTROL OVER
CONDITIONS UNDER WHICH THIS PRODUCT IS USED. MEDTRONIC, THEREFORE, DISCLAIMS ALL WARRANTIES, BOTH EXPRESSED AND IMPLIED WITH RESPECT TO
THE PRODUCT, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. MEDTRONIC SHALL
NOT BE LIABLE TO ANY PERSON OR ENTITY FOR ANY MEDICAL EXPENSES OR ANY DIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES CAUSED BY ANY USE,
DEFECT, FAILURE, OR MALFUNCTION OF THE PRODUCT, WHETHER A CLAIM FOR SUCH DAMAGES IS BASED UPON WARRANTY, CONTRACT, TORT, OR OTHERWISE.
NO PERSON HAS ANY AUTHORITY TO BIND MEDTRONIC TO ANY REPRESENTATION OR WARRANTY WITH RESPECT TO THE PRODUCT.
6 Instructions for Use English
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2013/JUL/16 at 10:32 a.m. Doc number: M333565F001 Rev. 1A [28L(03)]
Printspec j - 8.5 x 11.0 inches