BARD Biopsy EnCor Enspire Instrucciones De Uso página 8

Guidance and Manufacturer's Declaration – Immunity
All ME Equipment and ME Systems that are NOT Life-supporting
Table 7: Guidance and Manufacturer's Declaration – Immunity
The E E
®
Biopsy System should ensure that it is used in such an environment.
Immunity Test
Radiated
Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the
Equipment and Systems that are NOT Life-supporting
Table 8: Recommended Separations Distances for the
The E E Breast Biopsy System is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer or user of the
®
E E
®
Equipment and the E E
Max Output Power (Watts)
0.01
0.1
1
10
100
Table 9: Cable Length
Cable
Equipotential Post
The purpose of the Industry Standard Equipotential Post on the rear of the
To connect the E ® Breast Biopsy System to an Equipotential Network, snap the Equipotential Network Socket over the Equipotential Post on the rear of the
base unit. To remove The E
How Supplied/Stored
The ®
• E ® and E ®
supplied sterile for single patient use only.
Warranty
under this limited product warranty will be limited to repair or replacement of the defective product, in Bard Peripheral Vascular's sole discretion or refunding your net price paid. Wear and tear from normal use or
defects resulting from misuse of this product are not covered by this limited warranty.
TO THE EXTENT ALLOWABLE BY APPLICABLE LAW, THIS LIMITED PRODUCT WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT
LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT WILL BARD PERIPHERAL VASCULAR BE LIABLE TO YOU FOR ANY
INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM YOUR HANDLING OR USE OF THIS PRODUCT.
Some states/countries do not allow an exclusion of implied warranties, incidental or consequential damages. You may be entitled to additional remedies under the laws of your state/country.
the user should contact Bard Peripheral Vascular, Inc. to see if additional product information is available.
EN/IEC 60601 Test Level
3 Vrms
150 kHz – 80 MHz
3 V/m
80 MHz – 2.7 GHz
Breast Biopsy System as recommended below, according to the maximum output power of the communications equipment.
®
Separation (m)
150 kHz to 80 MHz
D=(3.5/V1)(Sqrt P)
.1166
.3689
1.1666
3.6893
11.6666
E
®
Compliance Level Electromagnetic Environment – Guidance
Portable and mobile communications equipment should be separated from the
E E
listed below:
where P is the max power in watts and D is the recommended separation distance
in meters.
Interference may occur in the vicinity of equipment containing a transmitter.
® Breast Biopsy System
Separation (m)
80 MHz to 800 MHz
D=(3.5/E1)(Sqrt P)
.1166
.3689
1.1666
3.6893
11.6666
Length (Minimum)
Breast Biopsy System is to provide a connection point to reduce the possibility of voltage potentials between touchable
®
and E
® ®
Breast Biopsy System by no less than the distances calculated/
®
Separation (m)
800 MHz to 2.7 GHz
D=(7/E1)(Sqrt P)
E Breast
®
® Breast Biopsy System
.2333
.7378
2.3333
7.3786
23.3333
® Breast Biopsy System