UroShield® User Manual
20-100-0022 Ver. 02
30
Table 3: UroShield® Electromagnetic Immunity (Continuation)
UroShield Essential Performance
The UroShield® is applied on the Foley 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.
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
UroShield® is intended for use in the electromagnetic environment specified below. The customer or user
of the UroShield® should assure that it is used in such an environment.
Immunity test
IEC 60601 level
Compliance level
IEC 61000-4-6
Conducted RF
3 Vrms
150 kHz to 80 MHz
6 Vrms in ISM bands (6.765 MHz to 6.795
MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz
to 27.283 MHz; and 40.66 MHz to 40.70 MHz)
and amateur bands (1.8 MHz to 2.0 MHz, 3.5
MHz to 4.0 MHz, 5.3 MHz to 5.4 MHz, 7 MHz
to 7.3 MHz, 10.1 MHz to 10.15 MHz, 14 MHz
to 14.2 MHz, 18.07 MHz to 18.17 MHz, 21.0
MHz to 21.4 MHz, 24.89 MHz to 24.99 MHz,
28.0 MHz to 29.7 MHz and 50.0 MHz to 54.0
MHz)
[V] = 3 Vrms
[V] = 6 Vrms
IEC 61000-4-3
Radiated RF
10 V/m
80 MHz to 2.7 GHz
[E] = 10 V/m
Proximity fields from
RF wireless
communications
equipment
385 MHz
27 V/m
450 MHz
28 V/m
710 MHz
9 V/m
745 MHz
780 MHz
810 MHz
28 V/m
870 MHz
930 MHz
1720 MHz
28 V/m
1845 MHz
1970 MHz
2450 MHz
28 V/m
5240 MHz
9 V/m
5500 MHz
5785 MHz
