8930EN_5.fm 12/17/10 2:44 pm
UCxxxxxx EN
7 x 9 inches (178 mm x 229 mm)
Chapter 5
88
Overview
English 8930 System User Guide 2010-12
MA07445A008
Rev X
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Patients taking any medications that may affect the prostate
and bladder (alpha and beta blockers, antihistamines,
antidepressants, anticonvulsants, antispasmodics, and
antichololinergics) within one week of the Prostiva RF
Therapy Procedure
The treating clinician should be present at all times and the
following additional cautions should be observed with respect to
the patient's safety:
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The system should only be used by clinicians trained in
prostate surgery.
The Prostiva RF Therapy Procedure, unlike transurethral
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resection of the prostate, does not provide tissue samples for
pathological examination. For this reason, it is recommended
that patients treated with the system be followed on an annual
basis to assess any prostatic changes.
Interference produced by the operation of the high frequency
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surgical equipment may adversely influence the operation of
other electronic equipment.
Inspect the outside packaging of the hand piece and tubing
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system for integrity to ensure sterility.
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Inspect all components prior to use for any obvious signs of
damage that may have occurred during transit and/or storage.
In particular the return electrode should be checked prior to
use.
The Model 8929 Hand Piece is designed to operate only in
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conjunction with the Model 8930 Radio Frequency Generator.
It is not designed to operate with any other radio frequency
generator or electrosurgical power source.
Excessive risk (leakage) current may result if this equipment
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is connected to anything other than the manufacturer's
recommended power distribution system.
Use only Medtronic-recommended sterilization techniques
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outlined in the appropriate telescope Instructions for Use to
process the telescope.
When attached to a high energy light source, the telescope
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may emit a high intensity light beam that can be hazardous if
viewed directly. Keep tip of telescope or hand piece pointed
away from patient's eyes and avoid looking directly into light
beam.
Do not modify this equipment. Modification of this equipment
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can result in damage to the device, causing the device to
malfunction or become unusable.
Medtronic Confidential
CRMRef_R06