Appendix A - Compliance To Iec 60601-1-2 / 2Nd, 3Rd, And 4Th Editions - Bayer HealthCare MEDRAD Stellant Operation And Installation Manual

Appendix A - Compliance to IEC 60601-1-2 / 2nd, 3rd,
and 4th Editions
®
The MEDRAD Stellant Imaging System Interface (ISI) 700 Module complies with the requirements of:
IEC 60601-1-2: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance –
Collateral standard: Electromagnetic compatibility – Requirements and tests
CISPR 11: Industrial, scientific and medical (ISM) radio-frequency equipment- Electromagnetic disturbance characteristics –
Limits and methods of measurement
IEC 61000-3-2: Electromagnetic compatibility (EMC) – Part 3-2: Limits – Limits for harmonic current emissions (equipment input
current ≤ 16 A per phase) (This does not apply to Class A equipment.)
IEC 61000-3-3:Electromagnetic compatibility (EMC)- Part 3-3: Limits - Limitation of voltage changes, voltage fluctuations and
flicker in public low-voltage supply systems, for equipment with rated current ≤ 16 A per phase and not subject to conditional
connections) (This does not apply to Class A equipment.)
IEC 61000-4-2: Electromagnetic compatibility (EMC) – Part 4-2: Testing and measurement techniques – Electrostatic discharge
immunity test
IEC 61000-4-3: Electromagnetic compatibility (EMC) – Part 4-3: Testing and measurement techniques – Radiated, radio-
frequency, electromagnetic field immunity test
IEC 61000-4-4: Electromagnetic compatibility (EMC) – Part 4-4: Testing and measurement techniques – Electrical fast transient/
burst immunity test
IEC 61000-4-5: Electromagnetic compatibility (EMC) – Part 4-5: Testing and measurement techniques – Surge immunity test
IEC 61000-4-6: Electromagnetic compatibility (EMC) – Part 4-6: Testing and measurement techniques – Immunity to conducted
disturbances, induced by radio frequency fields
IEC 61000-4-8: Electromagnetic compatibility (EMC) – Part 4-8: Testing and measurement techniques – Power frequency
magnetic field immunity tests
IEC 61000-4-11: Electromagnetic compatibility (EMC) – Part 4-11: Testing and measurement techniques – Voltage dips, short
interruptions and voltage variations immunity tests
This system is in compliance to IEC-60601-1-2 / 2nd, 3rd, and 4th edition Standards. Special precautions regarding
Electromagnetic Compatibility (EMC) are required for installation and use of this system. Detailed EMC information contained in
this addendum is intended to reflect conformance to IEC-60601-1-2 / 2nd, 3rd, and 4th edition standards.
WARNING: For proper operation, use only accessories and options provided by Bayer that are designed specifically
for the system. Other non-Bayer approved accessories or options may cause equipment damage or may result in
increased emissions or decreased immunity of the system. System accessories listed in the operation manual comply
with the requirements of electromagnetic emissions and immunity standards IEC-60601-1-2 / 2nd, 3rd, and 4th
edition.
WARNING: Do not use system adjacent to or stacked with other equipment. Use of this equipment adjacent to or
stacked with other equipment should be avoided because it could result in improper operation. If adjacent or stacked
use is necessary, the system and the other equipment should be observed to verify normal operation in the
configuration in which it will be used.
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