Medtronic Symplicity Spyral Handbuch Seite 7

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Avoid occluding renal blood flow during energy delivery.
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During energy delivery, do not move the Symplicity Spyral™ catheter or guidewire and do not inject saline or contrast agent.
■ Increased vessel reactivity, such as spasm, may be encountered when treating in areas with reduced blood flow.
■ In the event that the Symplicity G3™ generator stops due to high impedance or temperature, consider withdrawing the Symplicity Spyral™ catheter and cleaning the electrodes of
potential coagulum or replacing the Symplicity Spyral™ catheter before RF energy is re-applied. Use only sterile saline and gauze pad to clean the electrodes.
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Do not touch a Symplicity Spyral™ catheter electrode and the dispersive electrode at the same time during energy delivery. Superficial skin burns could occur.
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Do not allow a Symplicity Spyral™ catheter electrode or dispersive electrode to come into contact with a metal instrument or surface during energy delivery. Superficial skin burns
could occur.
Please consult the Symplicity G3™ generator user manual for additional warning and precautions.
8. References
■ The physician should consult recent literature on current medical practices for peripheral interventions.
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The Symplicity G3™ generator user manual should be consulted for more details on how to operate the generator.
9. Instructions for Use
Closely follow these Instructions for Use and consult the Symplicity G3™ generator user manual for additional instructions for use.
9.1. Equipment and Procedure Preparation
1. For proper equipment ventilation, position the Symplicity G3™ generator more than 31 cm (12 in) away from a wall, and do not cover the generator while in use.
2. If desired, insert the foot switch connector(s) into respective receptacles on rear panel of the Symplicity G3™ generator.
3. Plug in the power cable into the back panel of the Symplicity G3™ generator and turn it on by pressing the on/off switch also located on the back panel.
4. Check for any system indicator messages or warnings (eg, fault or status lights). Following a system self-test, the system is in Standby mode and no measurements are possible.
After successful self-test, the front panel will display a screen prompting the user to connect a catheter into the Symplicity G3™ generator.
5. Gather accessories needed for the procedure such as dispersive electrode, 6 Fr guide catheter 45 to 90 cm, introducer sheath, 0.36 mm (0.014 in) nonhydrophilic guidewire, stopcock
sidearm, and Tuohy-Borst adapter.
6. Gather medications needed for the procedure such as pain medications, atropine (in case heart rate drops during ablation), nitroglycerine to prevent vessel spasm, and heparin to
maintain adequate activated clotting time (ACT).
9.2. Patient Preparation
1. A disposable dispersive electrode specified for adult use that complies with IEC 60601-2-2 is required. Prepare the patient using standard techniques for electrosurgery and
catheterization. Ensure the patient's entire body, including extremities, is insulated from contact with grounded metal parts. Closely follow instructions provided by the manufacturer
of the dispersive electrode. The dispersive electrode should be placed on the thigh or other non-bony area of the body, and should be outside of the angiogram field of view. Shave
skin if necessary for good contact between the dispersive electrode and the skin. Failure to achieve good skin contact by the entire adhesive surface of the dispersive electrode may
result in a burn or high impedance measurements. Do not apply the dispersive electrode where fluid may pool.
2. Connect the dispersive electrode to the Symplicity G3™ generator; into the receptacle located on the side panel.
3. Ensure that patient has intravenous (IV) access for drug administration during the procedure. Prior to starting the procedure, appropriate systemic anticoagulation (such as heparin)
should be provided to the patient. An activated clotting time (ACT) of at least 250 seconds should be maintained during RF delivery.
4. Prepare the patient for catheter placement using standard interventional techniques: obtain femoral access, place a 6 Fr. Introducer sheath and position a guide catheter (eg, (L)IMA,
or RDND1/RDC1, ≤90 cm in length) into the target renal artery following manufacturer's instructions. Connect the Tuohy to the guide catheter and the stopcock sidearm to the Tuohy.
5. Administer pain medication at least 5 minutes prior to ablation. Check vital signs throughout the procedure.
9.3. Catheter Insertion in Renal Artery
1. Using aseptic technique, carefully remove the tray containing the Symplicity Spyral™ catheter from the single pouch, sterile barrier packaging.
2. Once the tray is in the sterile field, carefully remove the lid by pulling on the lid pull tab to gain access to the Symplicity Spyral™ catheter and integrated cable.
3. Remove the coiled cable from the tray and place on a stable sterile surface. Grip the Symplicity Spyral™ catheter handle with one hand and the hoop with the other hand. Carefully
remove the handle and hoop from the tray and place on the stable sterile surface next to coiled cable.
4. Remove the twist-tie clip from the coiled portion of the cable and pass the integrated cable out of the sterile field for an assistant to connect the cable to the appropriate receptacle
on the side panel of the Symplicity G3™ generator. The cable should be secured to the table or drape using a towel clamp, hemostats, or equivalent to help prevent movement of
the Symplicity Spyral™ catheter and handle.
5. An assistant outside the sterile field must perform patient selection on the touchscreen (new patient or same patient).
6. Advance a 0.36 mm (0.014 in) guidewire into target vessel.
■ It is recommended to use only nonhydrophilic guidewires.
■ It is recommended to use guidewires with flexible distal tips.
■ To avoid kidney perforation do not advance the guidewire too distal in the renal artery.
7. Remove the Symplicity Spyral™ catheter from the hoop; ensure that the straightening tool stays with the handle when pulling the catheter out of the hoop. Inspect the Symplicity
Spyral™ catheter for damage.
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If the Symplicity Spyral™ catheter is damaged, do not use.
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Do not advance the Symplicity Spyral™ catheter into the hoop after full or partial removal from the hoop. If advanced, fully remove the Symplicity Spyral™ catheter from the
hoop and inspect for damage. If damaged, replace the Symplicity Spyral™ catheter.
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Do not flush the catheter while in the hoop, nor flush the catheter lumen prior to use. It is also not recommended to wipe the catheter with a wet gauze prior to use.
8. Slide the straightening tool over the spiral portion of the Symplicity Spyral™ catheter as illustrated in Figure 2, making sure that approximately 5 mm of catheter tip still protrudes
from the distal end of the straightening tool.
■ Stop if any excessive resistance is felt while advancing the straightening tool over spiral section of the catheter and assess for damage.
■ If electrodes are damaged, replace Symplicity Spyral™ catheter.
9. Squeeze the distal flare of the tool to secure the Symplicity Spyral™ catheter. Carefully insert the proximal end of the guidewire through the tip of the Symplicity Spyral™ catheter.
Continue to pass the guidewire through the Symplicity Spyral™ catheter until the guidewire exits through the rapid exchange port. This exit port is located 30 cm proximal to the
distal tip of the Symplicity Spyral™ catheter.
■ If the guidewire does not exit from the exit port, remove the guidewire from Symplicity Spyral™ catheter and reinsert the guidewire, assessing for device breaches.
■ If the Symplicity Spyral™ catheter is breached or damaged, replace the catheter and guidewire.
10. Once the guidewire has exited the Symplicity Spyral™ catheter rapid-exchange port, return the straightening tool by the handle to prevent interference with the guidewire.
11. Use nitroglycerine prior to advancing the Symplicity Spyral™ catheter in the artery to reduce risk of arterial spasm.
12. Advance the Symplicity Spyral™ catheter over the guidewire through the guide catheter until the shaft marker enters the rotating hemostatic valve (RHV).
13. Under fluoroscopic guidance, advance the Symplicity Spyral™ catheter until the distal electrode is located in the ostium of the main distal bifurcation of the renal artery.
14. The impedance monitoring screen (Figure 3) will then be displayed.
Note: If the display does not continue to the impedance monitoring screen, follow these steps:
a. Reconnect the Symplicity Spyral™ catheter. If this does not bring the impedance monitoring screen,
b. Verify appropriate dispersive electrode location, connection, and contact with patient. If needed, the location and dispersive electrode can be changed.
multilang_singlefront_28L(03):20130701, alldocMod:20130701, alldocStyle:20130625, master_pageset:20130625, languageLookup:20130104, table:20130121, characterJoin:20110211,
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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
Instructions for Use English 5