Ensuring Safety and Quality for an MCS+ Procedure 6-5
P/N 85213-30, Manual revision: B
WARNINGS FOR THE OPERATOR
Electrical shock
hazards
The operator should always use the MCS+ device with clean dry hands, or gloves.
The internal parts of the MCS+ device contain various electrical components.
Contact with any of these components, when the device is connected to an
external powered source, could result in an electrical shock to the operator and/
or donor/patient.
The operator should never remove any of the MCS+ cabinet panels. Maintenance
requiring access to the inner cabinet remains the responsibility of a Haemonetics-
trained technician.
The operator should not touch any internal parts of a non-medical device that,
after the removal of covers, connectors, etc., without a tool, could result in an
electrical shock. Likewise, the operator should not simultaneously touch the
donor/patient and any internal parts of a non-medical device that, after the
removal of covers, connectors, etc., without a tool, could result in an electrical
shock to the operator and/or donor patient.
Equipment in which protection against electric shock relies on basic insulation
only should not be used with the MCS+ device.
Leakage current
control
Each MCS+ device receives a careful inspection for leakage current prior to
leaving the factory. Haemonetics recommends that a control be performed for
current leakage by an authorized representative as part of the annual preventative
maintenance. It remains the responsibility of the apheresis center to ensure that
this control is performed.
In the event of any major spill in which fluid may enter the cabinet, or an impor-
tant voltage surge, the operator is responsible to ensure that a leakage current test
is performed before re-using the device. The control is necessary to avoid the risk
of electrical shock and should be conducted by an authorized Haemonetics
representative.
The operator is responsible for making sure that the leakage current of the final
configuration (the MCS+ device and any ancillary equipment attached to the
MCS+ device), comply with IEC 60601-1-1 Standard, Medical electrical equip-
ment in normal and single fault conditions.
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