Kowa AP-7000 Manuel D’Utilisation
8
Combinations of medical electrical equipment and non–medical electrical equipment
1.
Precautions for system
IEC 60601–1–1 “Safety requirements for medical electrical systems” describes the components combination grouped
into various clinical settings. The brief overview of IEC 60601–1–1 is shown below.
into various clinical settings. The brief overview of IEC 60601–1–1 is shown below.
Situation No.
Medically used room
Non-
medically
used room
Examples of
possible causes
for exceeding
LEAKAGE
CURRENT limits
Practical means
of compliance
Apply 16.5 in all
situations
Inside the
PATIENT ENVIRONMENT
Outside the
PATIENT
ENVIRONMENT
1
1a Items A and B
are ME
EQUIPMENT
EQUIPMENT
Multiplied
APPLIED PARTS
of the same type
can cause the
total PATIENT
LEAKAGE
CURRENT to
exceed limits See
Note 1.
APPLIED PARTS
of the same type
can cause the
total PATIENT
LEAKAGE
CURRENT to
exceed limits See
Note 1.
-
Verify total
PATIENT
LEAKAGE
CURRENT
PATIENT
LEAKAGE
CURRENT
1b Items A and B
are ME
EQUIPMENT
powered via a
MULTIPLE
SOCKET-
OUTLET
EQUIPMENT
powered via a
MULTIPLE
SOCKET-
OUTLET
Earth conductor of
the MULTIPLE
SOCKET-OUTLET
is broken See also
1a.
the MULTIPLE
SOCKET-OUTLET
is broken See also
1a.
-
Additional
PROTECTIVE
EARTH
CONNECTION
(for A or B) or,
PROTECTIVE
EARTH
CONNECTION
(for A or B) or,
-
Separating
transformer
transformer
1c Item A is ME
EQUIPMENT
and B is non-
ME
EQUIPMENT
and B is non-
ME
EQUIPMENT
Due to high
TOUCH
CURRENT of B
TOUCH
CURRENT of B
-
Additional
PROTECTIVE
EARTH
CONNECTION
(for B) or,
PROTECTIVE
EARTH
CONNECTION
(for B) or,
-
Separating
transformer
(for B)
transformer
(for B)
1d Item A is ME
EQUIPMENT
and B is non-
ME
EQUIPMENT
powered via a
MULTIPLE
SOCKET-
OUTLET
and B is non-
ME
EQUIPMENT
powered via a
MULTIPLE
SOCKET-
OUTLET
The earth
conductor of the
MULTIPLE
SOCKET-OUTLET
is broken or, Due
to high TOUCH
CURRENT of B
conductor of the
MULTIPLE
SOCKET-OUTLET
is broken or, Due
to high TOUCH
CURRENT of B
-
Additional
PROTECTIVE
EARTH
CONNECTION
(for A or B) or,
PROTECTIVE
EARTH
CONNECTION
(for A or B) or,
-
Separating
transformer
transformer
1e Item A is ME
EQUIPMENT
powered from
specified
power supply
in item B
powered from
specified
power supply
in item B
Due to high
TOUCH
CURRENT of B
TOUCH
CURRENT of B
-
Additional
PROTECTIVE
EARTH
CONNECTION
(for B) or,
PROTECTIVE
EARTH
CONNECTION
(for B) or,
-
Separating
transformer
(for B)
transformer
(for B)
1f Item A is ME
EQUIPMENT
powered from
non-ME
EQUIPMENT
power supply
in B
powered from
non-ME
EQUIPMENT
power supply
in B
A
IEC 60601
B
IEC 60601
Mains
Plug
Plug
Mains
Plug
A
IEC 60601
B
IEC 60601
MULTIPLE SOCKET-OUTLET
A
IEC 60601
B
IEC xxxxx
Mains
Plug
Plug
Mains
Plug
A
IEC 60601
B
IEC xxxxx
MULTIPLE SOCKET-OUTLET
A
IEC 60601
B
IEC xxxxx
Mains
Plug
A
IEC 60601
B
IEC xxxxx
DC/AC
Mains
Plug