Nexam Pro User Manual
240
Appendix A
Safety Information
The Safety Information in this appendix is intended for users who perform
investigations with the Nexam Pro measurement system. Before working with
the Nexam Pro measurement system and its manuals, please take notice of
the safety information as described in this appendix.
Safety information for users who install, test and maintain the Nexam Pro
measurement system can be found in the Nexam Pro Service & Installation
Manual (document code: MAN-00031).
The Nexam Pro 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 Nexam Pro measurement system must be purchased under the
supervision of a physician. For USA only: Caution: Federal law restricts this
device to sale by or on the order of a physician.
The Nexam Pro 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
•
ANSI/AAMI ES60601-1:2005 + C1:2009 + A1:2012 + A2:2012
•
CAN/CSA-C22.2 No. 60601-1:2014
•
SGS contract no. 710253
•
local directives and the Medical Device Directive (93/42/EEC).
•
SGS contract no. 710253
The Nexam Pro measurement system conforms to the above mentioned
requirements only when it is used with specified and approved LABORIE
modules/devices as mentioned in this document.
The instructions, cautions, and warnings in this manual should be followed by
the operator to ensure safe operation and to maintain the Nexam Pro
measurement system in a safe condition. Therefore, the use of the Nexam Pro
measurement system should be restricted to qualified personnel only.
Содержание Nexam Pro CIM
Страница 1: ...Nexam Pro User Manual...