Referencias; Standards - Abbott FreeGo Manual De Uso

REFERENCIAS - STANDARDS
• Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended.
• IPX1: Protected against dripping water (Accessory cables).
• IP25: IEC 60529 IP25 degree of protection against fingers (>12 mm) or water entering the
enclosure. Water jets from any direction shall have no harmful effect.
• EN 60601-1
(Ed. 3)
and essential performance.
• EN 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and
essential performance - Collateral standard: Electromagnetic compatibility - Requirements and
tests.
• EN 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and
essential performance - Collateral standard: Usability.
• EN 60601-1-8 Medical electrical equipment - Part 1-8: General requirements for basic safety and
essential performance - Collateral Standard: General requirements, tests and guidance for alarm
systems in medical electrical equipment and medical electrical systems.
• EN 60601-1-11 Medical electrical equipment – Part 1-11: General requirements for basic safety
and essential performance – Collateral Standard: Requirements for medical electrical equipment
and medical electrical systems used in the home healthcare environment.
• EN 61000-3-2 Electromagnetic compatibility (EMC) - Part 3-2: Limits - Limits for harmonic
current emissions (equipment input current ≤ 16 A per phase).
• EN 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 connection.
• EN 62366: Medical devices -- Application of usability engineering to medical devices.
The Abbott FreeGo Pump is intended for use in the electromagnetic environment specified below. The customer or the user of
the Abbott FreeGo Pump 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
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Medical electrical equipment - Part 1: General requirements for basic safety
Guidance and manufacturer's declaration – electromagnetic emissions
Compliance
Group 1
Class B
Class A
Complies
Electromagnetic environment – guidance
The Abbott FreeGo Pump 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.
The Abbott FreeGo Pump is suitable for use in all
establishments, including domestic establishments and those
directly connected to the public low-voltage power supply
network that supplies buildings used for domestic purposes.
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