2.1.2 Medical electrical equipment
Electrical equipment, provided with not more
than one connection to particular supply mains
and intended to diagnose, treat or monitor the
patient under medical supervision and wich
makes physical or electrical contact with the pa-
tient, and/or transfers energy to or fromthe pa
tient, and/or detects such energy transfer to or
from the patient. The equipment includes those
accessories defined by the manufactureras being
necessary to enable normal use of the equipment.
‘The power supply can also be obtained by means
of an internal electrical source. Medical eectrical
equipment can be categorised as class |or class I
depending on their degree of insulation. in lass |
devices, protection against indirect contact is
guarantecd by connection te a cafety conductor
(Fig. 2.2.a), while class Il protection is intrinsic in
that itis provided by double insulation orrein-
forced insulation (Fig. 2.2.5).
2.1.3 Medical electrical system
Combination of items of equipment, at least one
of which fs an item of medical electrical equip~
‘ment and inter-connected by functional connec
tion or use of a multiple portable socket outlet.
The system includes those accessories wnich are
needed for operating the system and arespeci-
fied by the manufacturer.
Medical electrical systems are groups of multiple
electromedical devices or of electromedical de-
vices with other non-electromedical devizes, con-
nected electrically both for the transfer ef data or
signals, and through their power supply.
One example could be a device that monitors the
physiological parameters of a patient and trans-
fers the corresponding data to another piece of
‘equipment which in turn processes them in order
to provide information useful for diagnosis.