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Owner’s Guide 3
Safety Standards
IEC Standard - International Standard - Medical Electrical Equipment
IEC 60601-1-1:2000 Safety requirements for medical electrical systems
IEC 60601-1:2012 + A1 General requirements for safety
General Safety Instructions
To achieve the optimal degree of subject and operator safety, consideration should
be given to the following guidelines when setting up a PowerLab system either as
stand-alone equipment or when using PowerLab equipment in conjunction with other
equipment. Failure to do so may compromise the inherent safety measures designed
into PowerLab equipment. ADInstruments front-ends are only suitable for operation
with ADInstruments PowerLabs. Front-ends are suitable for use with any S/, SP/, /20,
/25, /30 and /35 series and 15T PowerLabs (FE234 and FE238 only suitable for use with
35 series PowerLabs). Note that compliance with IEC60601-1 can only be achieved when
front-ends are used with a /35 series Powerlab.
T he following guidelines are based on principles outlined in the international safety
standard IEC 60601-1: General requirements for safety – Collateral standard: Safety
requirements for medical systems . Reference to this standard is required when setting
up a system for human connection. The user is responsible for ensuring any particular
configuration of equipment complies with IEC60601-1-1. Guidance on compliance with
this standard is provided in the following sections.
PowerLab systems (and many other devices) require the connection of a personal
computer for operation. This personal computer should be certified as complying with
IEC 60950 and should be located outside a 1.8 m radius from the subject (so that the
subject cannot touch it while connected to the system). Within this 1.8 m radius, only
equipment complying with IEC 60601-1 should be present. Connecting a system in this
way obviates the provision of additional safety measures and the measurement of
leakage currents.
Accompanying documents for each piece of equipment in the system should be
thoroughly examined prior to connection of the system.
While it is not possible to cover all arrangements of equipment in a system, some
general guidelines for safe use of the equipment are presented below:
•
Any electrical equipment which is located within the SUBJECT AREA should be
approved to IEC 60601-1.
•
Only connect those parts of equipment that are marked as an APPLIED PART to
the subject. APPLIED PARTS may be recognized by the BF symbol which appears
in the Safety Symbols section of these Safety Notes.
•
Never connect parts which are marked as an APPLIED PART to those which are
not marked as APPLIED PARTS.