Boston Scientific MAESTRO 4000 Manual De Instrucciones página 24

Device Description
Class I, Defibrillation proof Type CF Equipment, IPX0, not AP/APG
Mode of Operation: Continuous
EMC Emissions and Susceptibility: The Maestro 4000 Cardiac Ablation System has been tested and found
to comply with the limits for medical devices to the IEC 60601-1-2:2007. These limits are designed to
provide reasonable protection against harmful interference in a typical medical installation. This System
generates, uses, and can radiate radiofrequency energy and, if not installed and used in accordance with
the instruction given below, may cause harmful interference to other devices in the vicinity. However, there
is no guarantee that interference will not occur in a particular installation.
TUV Rheinland of North America Certified.
IEC 60601-1
-1-1, -1-2, -1-4
-2-2
Electrical Isolation
Leakage current conforms to IEC 60601-1
Dielectric withstand conforms to IEC 60601-1
Guidance and manufacturer's declaration – electromagnetic emissions
The Maestro 4000 Cardiac Ablation System is intended for use in the electromagnetic environment
specified below. The customer or the user of the Maestro 4000 Cardiac Ablation System should assure that
it is used in such an environment.
Emissions Test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Guidance and manufacturer's declaration – electromagnetic immunity
The Maestro 4000 Cardiac Ablation System is intended for use in the electromagnetic environment
specified below. The customer or the user of the Maestro 4000 Cardiac Ablation System should assure that
it is used in such an environment.
Immunity test
Electrostatic
discharge (ESD)
IEC 61000-4-2
24
Black (K) ∆E ≤5.0
Maestro 4000™ Cardiac Ablation System Safety Specifications
Compliance Electromagnetic environment – guidance
Group 1 The Maestro 4000 Cardiac Ablation System must emit
electromagnetic energy in order to perform its intended
function. Nearby electronic equipment may be affected.
Class A The Maestro 4000 Cardiac Ablation System is suitable for use
in all establishments other than domestic and those directly
connected to the public low-voltage power supply network
Class A
that supplies buildings used for domestic purposes.
Complies
IEC 60601 test level Compliance level Electromagnetic environment - guidance
±6 kV contact ±6 kV contact
±8 kV air ±8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Maestro 4000™ Cardiac Ablation System Operator's Manual, Global