Warnings - Medtronic ProstivaRF Therapy 8930 Bedienungsanleitung

8930EN_5.fm 12/17/10 2:44 pm
UCxxxxxx EN
7 x 9 inches (178 mm x 229 mm)

Warnings

MA07445A008 Rev X
■ Presence of any prosthetic device in the region that may
interfere with the procedure
Patients whose prostate has been previously treated with
■
non-pharmacological therapies (such as TUMT, Laser, or TURP)
Presence of a cardiac pacemaker, implantable defibrillator, or
■
malleable penile implants
Patients with any component(s) of an implantable
■
neurostimulation system; energy from the Prostiva RF System
may be transferred through the implanted system and may
damage the patient's tissue in the area of the implanted
system components. This applies whether the
neurostimulation system is "off" or "on". The neurostimulation
system components may also be damaged.
Read all Warnings, Precautions, and Instructions for Use carefully
prior to use. Failure to read and follow all instructions, or
failure to observe all stated warnings, could cause serious
injury or death to the patient.
Return electrode- Failure to properly place the return
■
electrode may result in patient burns or poor electrical
performance. Refer to "Attaching Return Electrode (Neutral
Electrode)" on page 66, for complete instructions.
Return electrode- The Model 8934 Return Electrode is
■
designed for use only with the Medtronic Model 8930 RF
Generator.
■ Patient grounding- The patient should not come into contact
with metal parts that are earthed or that have an appreciable
capacitance to earth.
Skin-to-skin contact- Antistatic sheeting is recommended for
■
protection. Skin-to-skin contact (between the legs or between
the arms and body) should be avoided, for example, by
insertion of dry gauze.
Needle placement- Proper placement of the needles and
■
accurate needle length selections are essential. Improper
positioning of the hand piece, misplacement of the needles, or
improper needle length selections could result in damage to
the external sphincter or urethra, perforation of the prostatic
capsule or bladder neck, incomplete ablation, incontinence, or
damage to the rectum.
TUNA Therapy Clinical Overview
2010-12 8930 System User Guide English
Medtronic Confidential
CRMRef_R06
85
Overview