Precautions - Medtronic Prostiva 8930 Guía Para El Usuario

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

Precautions

MA07445A008 Rev X
■ Flammable agents- Flammable agents used for cleaning or
disinfecting are not recommended. If used, they should be
allowed to evaporate before application of radio frequency
energy. Because there is a risk of pooling flammable solutions
under the patient, any pooled fluid should be removed before
using the radio frequency generator.
Equipment failure- The failure of the radio frequency
■
generator could result in an unintended increase of output
power.
Explosive gases- There is danger of ignition of endogenous
■
gas near the high frequency generator and accessories
(including the hand piece and telescope). Anesthetic mixtures
with air, oxygen, or nitrous oxide should be restricted from the
procedure site. When some materials such as cotton, wool,
and gauze are saturated with oxygen, there is a danger of
ignition from radio frequency energy.
Electric shock- To avoid the risk of electric shock, this
■
equipment must only be connected to a supply mains with
protective earth (eg, a properly-grounded electrical outlet).
Electric shock can lead to equipment damage, serious patient
injury, or death.
c
Grounding reliability can only be achieved when the
equipment is connected to an equivalent receptacle marked
"Hospital Only" or "Hospital Grade".
The safety and effectiveness of treating patients with the following
conditions has not been established:
Patients with an interest in the preservation of future fertility
■
Patients with previous rectal surgery other than
■
hemorrhoidectomy, previous radical pelvic surgery or pelvic
irradiation
Patients with PSA>10 ng/ml. Patients with PSA values
■
between 4-10 ng/ml must have negative core biopsies
Patients taking any medications that may affect the prostate
■
and bladder, such as 5-alpha reductase inhibitors,
antiandrogens, and gondatropin-releasing hormonal
medications within two months of the Prostiva RF Therapy
Procedure
TUNA Therapy Clinical Overview
2010-12 8930 System User Guide English
Medtronic Confidential
CRMRef_R06
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Overview