Remove the stiffening wire before use.
After the device is connected with the equipment, the cutting wire cannot touch any other equipment. Spark discharge may cause clinician burns.
When using an electrocardiograph or other physiological monitoring equipment simultaneously with the device on a patient, any monitoring equipment should be placed as far away as possible from the electrodes used with the device. Needle monitoring electrodes should not be used, as they may cause patient burns.
Sphincterotome Papillotome successfully pass radiated disturbance electrical testing. When the device is operating with the HF generator delivering HF current, electromagnetic interferences can occur when the HF-generators are used in proximity of diagnostic or monitoring equipment leading to potential inappropriate assessment of the intraoperative state of the patient.
Do not bend the tube (< 15mm). It may cause tube to be deformed permanently, thus, the device cannot be used.
When using the device in the vicinity of the heart, be sure to use it with the minimum necessary output. Spark discharge during operation may affect the heart.
During the preparation, do not quickly push and pull the thumb ring causing the distal end of the tube to be bent less than 90º. Do not do anything that might cause tube to kink. Rotating the handle while inserting the device into endoscope channel would cause tube to kink.
Sphincterotomes/Papillotomes are composed by a catheter and for that should always be straighten when used to avoid device damage.
The handle need to be operated forward. Operating it backward may damage the device.
The operating room must have good ventilation to avoid the accumulation of potentially flammable gases, as the use of electric current in the presence of these gases can cause an explosion.
The Sphincterotomes/Papillotomes must be used with HF cord, HF generator and grounding pad shall be CE marked and compliant with the electrical safety standards (IEC 60601), to ensure patient safety.
The contrast medium used with the device must be licensed in the EU. Off- label use is not promoted and may cause serious harm to the patient.
The device when applied to a patient with an implantable pacemaker or any active implantable device may cause malfunction or failure of the pacemaker or the active implantable device, seriously affecting the patient. Before proceeding, always confirm with a cardiologist or the manufacturer of the pacemaker or the active implantable device that it is safe.
If the patient required the use of an external defibrillator during the procedure involving the papillotome, it must be totally removed or disconnected from the HF surgical generator before delivering the electrical shock.
Do not operate the device if the entire length of the surgical accessories is exceeding the maximum permissible length defined for the HF surgical generator to be used
Before to operate the HF surgical generator, verify that all the electrical connections have been properly established and no visible metallic parts are accessible on the papillotome’s handle avoiding contact with wet tissues.
The papillotome is a surgery accessory intended to deliver high-frequency electrical power to the body tissue thanks to the embedded electrical wire. Due to the very low electrical resistance, the device is not dissipating heat. It’s a media to deliver the energy to the interface between the tip of the papillotome and the body tissues to be treated. The significant electrical resistant of the body tissues to be treated (in contact with the tip of the papillotome) induce heat to the tissues. During the short duration of power delivery by the HF generator, electromagnetic interferences can occur which could affect diagnostic or monitoring equipment leading to inappropriate assessment of the intraoperative state of the patient. Such potential interferences are inherent to the use of HF surgical generator in combination with surgery tool such as the papillotome.