User Manual

2. INSTALLATION/PREPARATION
2.18 Operator's Manual WEE-1000
General Requirements for Connecting in Medical Electrical Systems
When more than one electrical instrument is used, there may be electrical potential
difference between the instruments. Potential difference between instruments may
cause current to flow to the patient connected to the instruments, resulting in electrical
shock (micro shock). Therefore, electrical instruments must be appropriately installed
as specified in IEC 60601-1-1.
The following is an excerpt from IEC 60601-1-1 “Medical electrical equipment - Part
1-1: General requirements for safety - Collateral standard: Safety requirements for
medical electrical systems”. For details, refer to IEC 60601-1-1 and consult with a
biomedical engineer.
Examples of combinations of MEDICAL ELECTRICAL EQUIPMENT and non-
medical electrical equipment
IEC 60601/B = IEC 60601-1 EQUIPMENT of TYPE B with PATIENT connection
IEC 60601/F = IEC 60601-1 EQUIPMENT of TYPE BF or TYPE CF (or TYPE B
without PATIENT connection)
IEC 60601/X = IEC 60601-1 EQUIPMENT of TYPE B or TYPE BF or TYPE CF
IEC XXXXX = Equipment complying with, e.g. IEC 348, IEC 950 etc.
P: additional protective earth
Q: additional separating transformer
R: floating power supply
S: separation
Situation No. Equipment A Equipment B Solution
1 IEC 60601/X OK
1a IEC XXXXX
OK, if ENCLOSURE LEAKAGE
CURRENT is less than 0.5 mA. If
the ENCLOSURE LEAKAGE
CURRENT is more than 0.5 mA:
Solution Q (separating transformers).
2a IEC 60601/X IEC 60601/B OK
2b IEC 60601/F IEC XXXXX for B any one of P, Q, R
2c IEC 60601/B IEC XXXXX
for A solution P for B any one of P,
Q, R
3a IEC 60601/X IEC 60601/B OK
3b IEC 60601/F IEC XXXXX OK
3c IEC 60601/B IEC XXXXX for A solution P
4 see 3a, 3b, 3c
5a IEC 60601/X IEC 60601/B
for A solution P or S (groundloop
possible)
5b IEC 60601/X IEC XXXXX
for A solution P or S (groundloop
possible)
6a IEC 60601/X IEC 60601/X OK (with S)
6b IEC 60601/X IEC XXXXX OK (with S)