Kowa VX-10a, Instruction Manual, Page: 10 / 64

Introduction
Intr
oduction
P0-8
●
Combinations of medical electrical equipment and non- medical electrical equipment
IEC 60601-1 Annex I “ME system aspects” describes the summary of situations that could occur when different combinations
of equipment are used in various medical environments. The brief overview of IEC 60601-1 Annex I 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 EQUIP-
MENT
A
IEC
60601
B
IEC
60601
Mains
Plug Mains
Plug
Multiplied APPLIED
PARTS of the same
type can cause
the total PATIENT
LEAKAGE CUR-
RENT to exceed
limits See Note 1.
- Verify total PA-
TIENT LEAKAGE
CURRENT
1b Items A and B
are ME EQUIP-
MENT powered
via a MULTI-
PLE SOCKET-
OUTLET
A
IEC
60601
B
IEC
60601
MULTIPLE
SOCKET-OUTLET
Earth conductor
of the MULTIPLE
SOCKET-OUTLET
is broken See also
1a.
- Additional PRO-
TECTIVE EARTH
CONNECTION
(for A or B) or,
- Separating trans-
former
1c Item A is ME
EQUIPMENT
and B is
Non-ME
EQUIPMENT
A
IEC
60601
B
IEC
XXXXX
Mains
Plug
Mains
Plug
Due to high TOUCH
CURRENT of B
- Additional PRO-
TECTIVE EARTH
CONNECTION
(for B) or,
- Separating trans-
former (for B)
1d Item A is ME
EQUIPMENT
and B is
non- ME
EQUIPMENT
powered via
a MULTIPLE
SOCKET-
OUTLET
A
IEC
60601
B
IEC
XXXXX
MULTIPLE
SOCKET-OUTLET
The earth conduc-
tor of the MULTIPLE
SOCKET-OUTLET
is broken or, Due to
high TOUCH CUR-
RENT of B - Additional PRO-
TECTIVE EARTH
CONNECTION
(for A or B) or,
- Separating trans-
former