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Spectra Optia Apheresis System Operator’s Manual
261
Spectra Optia System Specifications
Symbols and Certifications
The symbols shown in Table 18-36 can appear on the Spectra Optia system, as applicable.
Table 18-36:
Spectra Optia system symbols and certifications
Symbol
Definition
Indicates that the product was manufactured in accordance with Annex II of the European Council
Directive 93/42/EEC, as amended.
Indicates that the device is certified by CSA International in accordance with applicable U.S. and
Canadian standards for conformance with the requirements of CAN/CSA-C22.2 No. 601-1-M90,
CAN/CSA-C22.2 No. 1010.2.20-94, and UL 60601-1, as well as the applicable respective
amendments to these standards.
Indicates that the device is classified as Type BF per safety standard EN 60601-1. This classification
is based on the degree of protection against electrical shock, as defined in that standard.
IP21
Indicates that the device is protected against access by solid objects and falling water, as defined in
standard IEC 60529.
Indicates that the device requires an alternating supply current.
Indicates a protective conductor terminal. The symbol is located near the chassis’ grounding
locations.
Indicates a protective earth ground. The symbol is located near the chassis’ main grounding location
and at other protective ground points.
Indicates that the main power is turned on.
Indicates that the main power is turned off.
Indicates that the equipment is subject to directive 2012/19/EU concerning waste electrical and
electronic equipment (WEEE) and must be disposed of accordingly.
Indicates a non-pyrogenic fluid pathway.
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