212 Chapter 12, Reference Information
P/N 120745-IE, Manual revision: AA Haemonetics
®
Cell Saver
®
Elite
®
User Manual
Appendix A: IEC/EN 60601-1-2:2001 Standard
Requirements
Caution: 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).
Operation
Precautions
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.
Mobile radio frequency (RF) communication equipment not approved by
Haemonetics and portable communication equipment can affect the system.
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.
In addition, the Cell Saver Elite device and accessories must not be placed
directly adjacent to, or on top of other equipment, unless specifically approved
by Haemonetics.
Caution: Grounding reliability can only be achieved when the equipment is
connected to a properly grounded outlet.
Essential
Performance
The Haemonetics Cell Saver Elite system has no performance characteristics
that have been determined to be essential performance.
1
1.
“Essential performance: performance necessary to achieve freedom from
unacceptable risk” (IEC/EN 60601-1 second edition IEC:2005)
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