ResMed Elisee 350, Clinical Manual

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8.6 Applicable standards
This ventilator complies with the following standards:
•
IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and
essential performance
•
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
•
IEC 60601-1-6: Medical electrical equipment – Part 1-6: General requirements for basic safety
and essential performance: Collateral standard: Usability
•
IEC 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
•
IEC 60601-2-12 (ISO 10651-1): Medical electrical equipment – Part 2-12: Particular
requirements for the safety of lung ventilators: Critical care ventilators
•
EN 794-1: Lung ventilators – Part 1: Particular requirements for critical care ventilators
•
EN 794-3: Lung ventilators – Part 3: Particular requirements for emergency and transport
ventilators
•
EN 1789: Medical vehicles and their equipment – Road ambulances
•
ISO 21647: Medical electrical equipment – Particular requirements for the basic safety and
essential performance of respiratory gas monitors
•
ISO 5356-1: Anaesthetic and respiratory equipment – Conical connectors – Part 1: Cones and
sockets
•
ISO 14971: Medical devices – Application of risk management to medical devices.
CE-marked device in accordance with Directive 93/42/EEC (Notified body: TÜV Süd – CE0123).
8.7 Electromagnetic emissions and immunity
Guidance and manufacturer’s declaration – electromagnetic
emissions
The Elisée 350 is intended for use in the electromagnetic environment specified below. The client
or user of the Elisée 350 should ensure that it is used only in such an environment.
Emissions tests Compliance Electromagnetic environment – Guidance
RF emissions CISPR 11 Group 1 The Elisée 350 uses RF energy only for its internal
functions. Consequently, 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 Elisée 350 is suitable for use in all establishments
other than domestic and can be used in domestic
establishments and those directly connected to the
public low voltage power supply network which
supplies buildings used for domestic purposes,
provided that the following warning is heeded:
WARNING
This device/system is intended to be used only by
health care professionals. This device/system may
cause RF interference or it may interfere with the
operation of a nearby device. It may be necessary to
take the appropriate measures to attenuate this
interference, such as re-orienting or relocating the
Elisée 350 or shielding the location.
Harmonic emissions
IEC 61000-3-2
Class A
Protection of the general electric
network – Voltage fluctuations/
flicker emissions Complies