LABORIE Solar Blue, Service & Installation Manual

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Appendix A © 2008
– 2020 by MMS B.V.
139
Appendix A Safety Information
The Safety information in this appendix is intended for users who install, test
and maintain the Solar Blue measurement system. Before working with the
Solar Blue measurement system and its manuals, please take notice of the
safety information as described in this appendix.
Safety information for users performing investigations by using the Solar
Blue measurement system can be found in the So
lar Blue User’s Manual
(Document Code: 0075-MAN-093-EN).
The Solar Blue measurement system is a prescription device to be used only
by physicians or individuals who have been trained and authorized by a
physician or by a medical institution, under the supervision of a physician.
The Solar Blue measurement system must be purchased under the
supervision of a physician. For US only: Caution: Federal law restricts this
device to sale by or on the order of a physician.
The Solar Blue measurement system complies with the requirements as stated
by

IEC 60601-1:2005 + CORR. 1:2006 + CORR.2:2007 + A1:2012

IEC 60601-1-2:2014

MDD, Medical Device Directive 93/42/EEC, Class IIa medical device

ANSI/AAMI ES60601-1:2005 + C1:2009 + A1:2012 + A2:2012

CAN/CSA-C22.2 No. 60601-1:2014

SGS contract no. 710253
The Solar Blue measurement system conforms to the requirements only when
it is used with specified and approved LABORIE modules/devices as
mentioned in this document.
The Solar Blue measurement system complies with Part 15 of the FCC Rules.
Operation is subject to the following two conditions: (1) this device may not
cause harmful interference, and (2) this device must accept any interference
received, including interference that may cause undesired operation. This
device contains FCC-ID POOWML-C40XX.