CardioFocus HeartLight X3 Manual De Instrucciones página 5

 Use of controls, adjustments, or performance of procedures other than those specified in this operation
manual may result in hazardous radiation exposure. Personnel operating or performing maintenance on the
Console must be thoroughly familiar with all safety requirements and operating procedures. Follow all
safety precautions and adhere to all warnings to ensure safe operation.

Observe that the Balloon is in stable contact with atrial tissue prior to and during ablation. RAPID mode
energy delivery requires stable contact. It is the operator's responsibility to insure stable contact. If
unstable contact is observed, stop ablating until stable contact is verified before resuming RAPID mode
ablation or ablate in Manual mode.
 Observe the movement of the laser's aim while delivering energy in RAPID mode. Do not continue to deliver
laser energy if the laser's aim does not move or the movement is erratic. Continuing to deliver energy may
result in damage to the device and/or serious injury to the patient or gaps in energy delivery.

Do not modify the Balloon Catheter, Console or accessories in any way since this may result in damage to
the device and/or serious injury to the patient and/or medical personnel.
 Therapeutic application requires adequate experience in the use of diode laser systems and optical fiber
delivery devices.
 Do not use a Lesion Generator that is kinked or otherwise damaged. Use of such a Lesion Generator may
result in injury to the patient or medical personnel from unintended laser emission.
 The aiming beam passes through the same optical fiber as the therapeutic beam. If the aiming beam is not
visible at the distal end of the Balloon Catheter, if its intensity is reduced, or if the beam is visible at
locations other than the distal end, the Lesion Generator may be damaged and should be replaced.

Do not bend or kink the Balloon Catheter. Improper use of the Balloon Catheter can cause a malfunction and
laser energy to be emitted at points other than the Balloon Catheter tip. Unintended laser emission can cause
serious injury to the patient and/or medical personnel. Use of such a Catheter may result in injury to the
patient or medical personnel from unintended laser emission.
 Do not energize the Class 4 ablation laser while the Balloon is outside the patient's body. Do not turn on the
illumination light when looking directly at the Balloon. Do not look directly into any light source on the
Console.
 Withdrawing or advancing the Lesion Generator through a tight Catheter bend can damage the Lesion
Generator.
 Do not use excessive force when advancing or removing the Catheter. Use caution during device placement
to avoid adverse events.
 When advancing the catheter, use fluoroscopy to observe the distal tip of the catheter. Do not advance the
catheter if the tip is bent.
 Observe the endoscopic image during Balloon inflation. If circumferential tissue contact is seen prior to full
inflation, retract the Balloon slightly to avoid inflation within the vein.
 Under no circumstances should energy be delivered more than 0.5cm distal to the vein ostium.
 Energy should not be delivered within 3mm of a side branch. If such delivery cannot be avoided, review pre-
procedure CT or MRI images and/or obtain an angiogram and insure that the path of the energy will not pass
through the side branch.
HeartLight X3 Catheter Instructions for Use
06-5511 REV A
Page 5
ECN-4541