How Supplied - Bard EnCor ENSPIRE Mode D'emploi

Immunity Test
Recommended Separation Distances between portable and mobile RF Communications equipment and the E
The E C E Breast Biopsy System is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer
N OR NSPIRE TM
or user of the E C E
N OR NSPIRE
mobile RF Communications Equipment and the E
communications equipment.
Max Output Power (Watts)
0.01
0.1
1
10
100
Equipotential Post:
The purpose of the Industry Standard Equipotential Post on the rear of the E
possibility of voltage potentials between touchable conductive parts of all the different Medical Equipment Systems within the Patient and Operator area.
To connect the E
E
TM
NCOR NSPIRE
rear of the E E Breast Biopsy System base unit. To remove The E
NCOR NSPIRE TM
equipotential Network Socket off the Equipotential Post.
L.

HOW SUPPLIED

The E C E
N OR NSPIRE TM
C , E C MRI and E
N OR ® N OR ®
each driver for Cleaning and Maintenance instructions.
The vacuum canister, probes and tubing cassettes are supplied sterile for single patient use only.
M. REFERENCES
PK1237100 (E C E Tubing Cassette IFU), IU0055 (E
N OR NSPIRE TM
driver and probe IFU)
N. WARRANTY
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.
An issue or revision date and a revision number for these instructions are included for the user's information on the last page of this booklet. In the event
36 months have elapsed between this date and product use, 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 to 80 MHz
Equipment and Systems that are NOT Life-supporting
Recommended Separations Distances for the E
Breast Biopsy System can help prevent electromagnetic interference by maintaining a minimum distance between portable and
TM
C E
N OR NSPIRE
TM
Separation (m)
150kHz to 80MHz D=(3.5/V1)(Sqrt P)
.1166
.3689
1.1666
3.6893
11.6666
Cable
Breast Biopsy System to an Equipotential Network, snap the Equipotential Network Socket over the Equipotential Post on the
C 360 drivers are sold separately. The drivers are supplied non-sterile. Reference the Instructions for Use included with
N OR ®
N
Compliance Level
Pass Portable and mobile communications equipment should be separated from
Pass the E C
N OR
distance in meters.
site survey, should be less than the compliance levels (V1 and E1).
Interference may occur in the vicinity of equipment containing a transmitter.
C E
N OR NSPIRE
Separation (m) 80 to 800MHz
D=(3.5/E1)(Sqrt P)
11.6666
Cable Length
E Breast Biopsy System is to provide a connection point to reduce the
NCOR NSPIRE TM
E Breast Biopsy System from the Equipotential Network, pull the
NCOR NSPIRE TM
C 360 driver and probe IFU), IU0072 (E
OR ®
7
Electromagnetic Environment – Guidance
E Breast Biopsy System by no less than the distances
NSPIRE
TM
C E
N OR NSPIRE
TM
Breast Biopsy System
Separation (m) 800MHz to 2.5GHz
.1166
.3689
1.1666
3.6893
Length (feet)
C , E C MRI and E C
N OR ® N OR ® N OR
C driver and probe IFU) and IU0073 (E
N OR ®
TM
Breast Biopsy System
D=(7/E1)(Sqrt P)
.2333
.7378
2.3333
7.3786
23.3333
360 probes are sold separately.
®
C MRI
N OR ®