Medtronic Prostiva 8930 Guía Para El Usuario página 86

8930EN_5.fm 12/17/10 2:44 pm
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7 x 9 inches (178 mm x 229 mm)
Chapter 5
86
Overview
English 8930 System User Guide 2010-12
MA07445A008 Rev X
■ Sterile instrument- If a sterile instrument is accidentally
dropped while connected to the RF generator, it must not be
used. If this occurs, take the following steps immediately to
avoid risks of using a contaminated hand piece and the
possibility of electrical shock:
a. Turn off the RF generator.
b. Disconnect the RF generator power cord from the power
outlet.
c. Disconnect the RF cable from the RF generator.
d. Dispose of the hand piece properly according to
established facility policy and procedure; be sure to
remove telescope.
Single-use-only devices- The hand piece, return electrode,
■
and tubing system are intended for single use only. Do not
reuse, reprocess, or resterilize these devices. Reuse,
reprocessing, or resterilization may compromise the structural
integrity of the devices and/or create a risk of contamination of
the devices, which could result in patient injury, illness, or
death. Discard according to local environmental regulations.
Safety and efficacy- The safety and efficacy of the treatment
■
in patients with the following conditions has not been
established:
– Patients with a median lobe that grows into the bladder and
collapses across the bladder
– Patients with a transverse diameter of the prostate gland
that is greater than 64 mm
– Patients with prostate size above 50 cm
– Patients in ASA American Society of Anesthesiologists
(ASA) Risk Category Class IV
Heart disease- Patients with cardiac arrhythmia,
■
hypertension uncontrolled by medication, cardiac disease, or
congestive heart failure should be cleared by their cardiologist
before having a Prostiva RF Procedure.
Packaging inspection- Inspect each package prior to use.
■
Do not use if package is opened or damaged.
Aseptic technique-Use aseptic technique in all procedures.
■
In areas where fluid spillage is likely to occur, use plastic
sheeting to protect the generator.
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