Chapter 4, Safety and Patient Care Precautions
65
Haemonetics
®
Cell Saver
®
Elite
®
User Manual
P/N 120745-IE, Manual revision: AA
Warnings for the User
Electrical Shock
Hazards
The user should always use the device with clean dry hands, or 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 to the user and/or patient.
The user should never remove any of the device panels. Maintenance that
requires removal of these panels remains the responsibility of a Haemonetics
trained technician.
Leakage
Current Control
In the event of any major spill in which fluid may enter the cabinet, the user is
responsible to ensure that a leakage current test is performed before re-using
the device. The test is necessary to avoid the risk of electrical shock and should
be conducted by a Haemonetics trained technician.
The device meets the IEC/EN 60601-1 standard, medical electrical equipment,
general requirements for safety (See
Table 4 “Environmental Specifications” on
for specifications). Each device receives a careful inspection for
leakage current prior to 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 local Haemonetics representative 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.
Caution:
Grounding reliability 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