Safety and Patient Care Precautions
63
Haemonetics
®
Cell Saver
®
Elite
®
+ User Manual
P/N 130859-US, Manual Revision: AA
Warnings for the User
Electrical Shock
Hazards
Warning: Always use the device with clean dry hands, or disposable
gloves. The internal parts of the device contain various electrical
components. Contact with any of these components when the device is
connected to an external power source could result in an electrical
shock. Thus, the panels should not be removed without first powering off
and unplugging the device. Access to the inner cabinet should only be
performed by a Haemonetics trained technician.
Leakage
Current Control
In the event of any major spill in which fluid enters the centrifuge or suction
pump, a leakage current test should be performed before re-using the device.
To avoid the risk of electrical shock, the test should be conducted by an on-site
biomedical or clinical engineer.
The device meets the IEC/EN 60601-1 standard, medical electrical equipment,
general requirements for safety (See
Table 9, "Environmental Specifications"
for specifications). Each device receives a careful inspection for
leakage current and ground continuity before leaving the factory.
Power Outlet
Connection
A power cord is supplied with the device. Do not replace the power cord with a
substitute. If necessary, contact the Haemonetics Customer Care Center for a
replacement. Always ensure the power cord is connected to an appropriately
grounded power source.
The Cell Saver Elite+ device must be operated in an environment compatible
to the requirements of the IEC/EN 60601-1-2 Standard, Electromagnetic
compatibility (EMC). Any accessories and cables not approved by
Haemonetics used in conjunction with the device may increase hazards and
influence compatibility with EMC requirements. Therefore, non-approved
accessories and cables must not be used.
Warning: Ground continuity can only be achieved when the equipment is
connected to a properly grounded outlet.
Laser Radiation
Hazards
Failing to follow the procedures correctly, using controls or making adjustments
not specified in the manual could result in hazardous radiation exposure.
Mechanical
Hazards/
Rotating Parts
As with any equipment containing rapidly rotating parts, the potential for severe
injury exists if personal contact is made, or if clothing becomes entangled with
the moving parts. The device contains a safety feature designed to prevent the
centrifuge from spinning if the system has not been properly secured.
