Operator's Manual

69
RefeRences and TRoubleshooTing
RefeRences and
TRoubleshooTing
Technical Description
Standards used in development of the pump
The following standards were used in whole or part in the development of the pump.
Medical Electrical Equipment:
EN 60601-1 (2006 + A1:2013 + A11:2011 + A12:2014) Ed3.1, Medical Electrical Equipment, Part I: General Requirements
for Safety. Amendment A1 (1993) Amendment A13 (1996) Amendment A2 (1995).
EN 60601-2-24 (2015), Medical Electrical Equipment, Part 2-24: particular Requirements for Safety of Infusion Pumps and
Controllers.
IEC 60601-1 (2005 + A1:2012) Ed3.1, Medical Electrical Equipment, Part 1: General Requirements for Safety. Amendment
1 (1991) Amendment 2 (1995).
IEC 60601-2-24 (2012), Medical Electrical Equipment, Part 2-24: Particular Requirements for Safety of Infusion Pumps and
Controllers.
CAN/CSA-C22.2 601.1-M90, Medical Electrical Equipment, Part 1: General Requirements for Safety - November 1990
(Canadian Deviations to IEC 60601-1) Update No. 2 (November 2003).
ANSI/AAMI ES60601-1 (2005/(R2012) + A1:2012) Ed 3.1, Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance
IEC 60601-1-8 (2012), Medical electrical equipment - Part 1-8: General requirements for basic safety and essential
performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems
EN 60601-1-8 (2007 + AC:2010), Medical electrical equipment - Part 1-8: General requirements for basic safety and
essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems
IEC 62304 (2015), Medical device software - Software life-cycle processes
EN 62304 (2006 + AC:2008), Medical device software - Software life-cycle processes
Electromagnetic Compatibility:
RTCA/DO -160G (2010), Radiated Emissions Only, Category M Limit.
EN 60601-1-2 (2015), Medical Electrical Equipment, Part 1-2: General Requirements for Safety - Collateral Standard:
Electromagnetic Compatibility - Requirements and Tests.
IEC 60601-1-2 (2014), Medical Electrical Equipment, Part 1-2: General Requirements for Safety - Collateral Standard:
Electromagnetic Compatibility - Requirements and Tests.
CISPR11 (2016), Limits and methods of measurement of electromagnetic disturbance characteristics of industrial,
scientific and medical (ISM) radio frequency equipment. Amendment 1 (1999) Amendment 2 (2002).
Miscellaneous Standards
IEC 60529 (2001), Degrees of protection provided by enclosures (IP Code).
EU RoHS Directive 2011/65/EU, Restriction of Hazardous Substances in Electrical and Electronic Equipment
REACH Regulation (EC) No.1907/2006, Registration, Evaluation, and Authorization of Chemicals (REACH)
2012/19/EU, Waste Electrical and Electronic Equipment (WEEE)
Essential Performance
The CADD
®
-Solis pump has the following essential performance characteristics:
The pump delivery will be at the set rate within the declared limits of accuracy under nominal conditions or
will provide an alarm.
The pump high priority alarms will remain operable.
The following pump protective systems will be operable or alarm:
• Pump Clock Self-Test
• Motor Safety Circuit Test
• Disposable Detection
• Air Detection
• Occlusion Detection
• Latch/Lock Sensors