Biofilm Formation And Urinary Tract Infections; General Safety; Essential Performance - NanoVibronix UroShield User Manual

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1.3 BIOFILM FORMATION AND URINARY
TRACT INFECTIONS
Urinary catheters readily acquire biofilms
after insertion; and the longer the catheter
remains in place, the greater the tendency
for the formation of biofilms, resulting in
urinary tract infections.
The initial step in biofilm formation is
the adhesion of bacteria to the catheter
surface. This occurs a few hours after urinary
catheter placement. Following attachment,
the bacteria begin to secrete an extra-
cellular polymeric matrix, which allows them
to survive and proliferate. The bacteria
and extra-cellular polymeric matrix , now
adherent to the catheter surface, is known as
biofilm which is highly resistant to antibiotics
and to the body's immune system.
The UroShield
bacterial biofilm formation by generating
ultrasound waves on the inner and outer
surfaces of the catheter.

GENERAL SAFETY

1.3
Thoroughly read and understand the safety
and operating instructions before attempting
to operate the UroShield®. This user manual
should be retained for future reference.
1.5

ESSENTIAL PERFORMANCE

The UroShield® is applied on the urethral or
suprapubic catheter and emits ultrasound
energy to its surface. The waves interfere
with the attachment of bacteria, which is the
initial step in biofilm formation, and increase
antibiotic efficacy against biofilm bacteria.
1
is intended to prevent
®