mammotome REVOLVE - Page 110

10-3
WARNING: This medical device emits electromagnetic energy that may interfere with other nearby medical
devices, which may cause those devices to malfunction or seriously harm the patient.
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The Mammotome revolve Dual Vacuum-Assisted Biopsy System is intended for use in the electromagnetic
environments specified below. The customer or user of the Mammotome revolve Dual Vacuum-Assisted
Biopsy System should assure that it is used in such an environment.
Emission Test
Compliance
Guidance
RF Emissions
CISPR 11
Class A
The Mammotome revolve Dual Vacuum-Assisted Biopsy System
uses RF energy only for its internal function. Therefore, its RF
emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
RF Emissions
CISPR 11
Class A
The Mammotome revolve Dual Vacuum-Assisted Biopsy System
must emit electromagnetic energy to perform its intended function.
Nearby electronic equipment may be affected.
Harmonic Emissions
IEC 61000-3-2
Class A
The Mammotome revolve Dual Vacuum-Assisted Biopsy System
is suitable for use in non-domestic establishments.
Voltage
fluctuations/flicker
emissions
IEC 61000-3-3
Class A
The Mammotome revolve Dual Vacuum-Assisted Biopsy System
is suitable for use in all non-domestic establishments and those
directly connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
EX Holster Only
FCC Compliance Statement:
“This device complies with Part 15 of the FCC rules. Operation is subject to the following two
conditions:
1. This device may not cause harmful interference, and
2. This device must accept any interference received, including inference that may
cause undesired operation:
“This portable transmitter with its antenna complies with FCC/IC RF exposure limits for
general population / uncontrolled exposure.”
RSS-Gen. General Requirements for Compliance of Radio Apparatus
“This device contains licence-exempt transmitter(s)/receiver(s) that comply with Innovation, Science
and Economic Development Canada’s licence-exempt RSS(s). Operation is subject to the following
two conditions:
1. This device may not cause interference.
2. This device must accept any interference, including interference that may cause undesired
operation of the device.”