Ensuring Safety and Quality for a PCS2 Procedure
4-5
P/N 85266-30, Manual revision: A
W
ARNINGS
FOR
THE
OPERATOR
Electrical shock
hazards
The operator should always use the PCS2 device with clean, dry hands, or gloves.
The internal parts of the PCS2 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.
The operator should never remove any of the PCS2 cabinet panels. Maintenance
requiring access to the inner cabinet remains the responsibility of a Haemonetics-
trained technician.
Leakage current
control
Each PCS2 device receives a careful inspection for leakage current prior to
leaving the factory. Haemonetics recommends that a control be performed for
leakage current 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.
Mechanical
hazards/rotating
parts
As with any equipment containing rapidly rotating parts, the potential for severe
injury exists if contact is made, or if clothing becomes entangled with the moving
parts. The PCS2 device contains a safety feature, designed to prevent the centri-
fuge from spinning if the system has not been properly secured. However, the
operator should respect the usual precautions taken when working with equip-
ment containing rotating mechanical parts.
Power outlet
connection
To comply with the IEC 60601-1-2 Standard for Medical Electrical Equipment,
general requirements for safety, it is not permitted to power the PCS2 device using
a multiple portable socket outlet, or an extension cord not supplied by Haemon-
etics.
