Bayer HealthCare Certegra, Operation Manual

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18 Compliance to IEC 60601-1-2 / 2nd, 3rd, and 4th Editions
The MEDRAD
®
Stellant CT Injection System with Certegra
®
Workstation complies with the require-
ments 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 distur-
bance 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 equip-
ment.)
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 tech-
niques – 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 immu-
nity 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.
WARNING: Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than 30 cm (12
inches) to any part of the injection system unless a greater separation distance is
required as indicated by the equation.
Otherwise, degradation of the performance of this
equipment could result.
E