CardioFocus HeartLight X3 Manual De Instrucciones página 4

3. Contraindications
This system is not compatible with Magnetic Resonance Imaging (MRI).
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This system is not intended for use in pediatrics.
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This system is not compatible with high frequency surgical equipment.
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This system should not be used to attempt to isolate the superior vena cava (SVC). In a small, non-
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controlled study
4. Warnings
Training - Only adequately trained personnel in a fully equipped electrophysiology laboratory should perform
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cardiac ablation procedures. This device should be used only by physicians trained in the use of
electrophysiology catheters and delivery systems. Personnel must be trained in the safe use of lasers. It is
strongly recommended that prior to first use by new clinician operators, that operator either (1) conducts a
procedure in an animal or a HeartLight simulator (2) attends a clinical case conducted by a trained clinical
user or (3) has a trained clinical user attend their first clinical case. Non-clinical nurses or technicians
operating the laser and cooling console should have in-service training by CardioFocus or its representative
prior to first clinical use.
 Operation Manual / Instructions for Use – Do not attempt to use the HeartLight Endoscopic Ablation System
before reading and completely understanding the applicable Operation Manual, 06-4955.
 The Catheter is for single use only and should not be re-sterilized. This device is intended only to be used
once for a single patient. Do not reuse, reprocess, or resterilize this device for purpose of reuse. Reuse,
reprocessing, or resterilization may compromise the structural integrity of the device or create a risk of
contamination of the device that could result in patient injury, illness, or death.
 Monitor patients closely - Monitor patients closely for clinical evidence of embolic events or myocardial
infarction following left side ablative procedures.
 Medical risks from the procedure should be explained to the patient and be included in the written informed
consent
 Minimize x-ray exposure – Minimize x-ray exposure to patient and clinical staff. Excessive X-ray exposure
can result in acute radiation injury and increase risk for somatic and genetic effects due to x-ray beam
intensity and fluoroscopic imaging exposure time.
 Avoid eye or skin exposure to direct or scattered radiation.
 Pregnancy – Careful consideration should be given to the use of this device in pregnant women because of
the risk associated with x-ray exposure.
 Personal Protective Equipment (PPE) – There is no HeartLight specific required PPE provided by
CardioFocus or needed to conduct HeartLight cases. Users should follow all proper precautions for the safe
conduct of standard electrophysiology cases as required at their institution including personal protection
from patient bodily fluids contact and X-ray exposure.
1 Electrical isolation of the superior vena cava by laser balloon ablation in patients with atrial fibrillation, J. Interventional Cardiac
Electrophysiology, November 2018, Volume 53, Issue 2, pp 217–223, Martín R. Arceluz, Pedro F. Cruz, Estela Falconi, Rosa Montes
de Oca, Reina Delgado, Jorge Figuero, Marta Ortega,José L. Merino
HeartLight X3 Catheter Instructions for Use
06-5511 REV A
1 of 13 patients, persistent phrenic nerve injury rate was reported in 23% of patients.
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