Smiths Medical CADD-Solis User Manual

45
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(1990), Medical Electrical
Equipment, Part I: General Requirements for
Safety. Amendment A1 (1993) Amendment
A13 (1996) Amendment A2 (1995).
 EN60601-2-24(1998), Medical Electrical
Equipment, Part 2-24: particular Requirements
for Safety of Infusion Pumps and Controllers.
 EN60601-1-4(1996), Medical Electrical
Equipment, Part 1-4: General Requirements
for Safety - Collateral Standard: Programmable
electrical medical systems. Amendment A1:
1999.
 IEC60601-1(2ndEdition,1988), Medical
Electrical Equipment, Part 1: General
Requirements for Safety. Amendment 1 (1991)
Amendment 2 (1995).
 IEC60601-1-4(2000), Medical Electrical
Equipment, Part 104: General Requirements
for Safety - Collateral Standard: Programmable
electrical medial systems.
 IEC60601-2-24(1998), 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).
ElectromagneticCompatibility
 RTCA/DO-160E(2004),Radiated Emissions
Only, Category M Limit.
 EN60601-1-2(2001), Medical Electrical
Equipment, Part 1-2: General Requirements
for Safety - Collateral Standard:
Electromagnetic Compatibility - Requirements
and Tests.
 IEC60601-1-2(Edition2.1,2004-11),
Medical Electrical Equipment, Part 1-2:
General Requirements for Safety - Collateral
Standard: Electromagnetic Compatibility -
Requirements and Tests.
 IEC61000-4-2(2001), Electromagnetic
Compatibility (EMC), Part 4-2: Testing
and measurement techniques. Electrostatic
Discharge immunity test.
 IEC61000-4-3(2006), Electromagnetic
Compatibility (EMC), Part 4-3: Testing and
measurement techniques. Radiated, radio
frequency, electromagnetic field immunity
test.
 IEC61000-4-4(2004), Electromagnetic
Compatibility (EMC), Part 4-4: Testing and
measurement techniques. Electrical fast
transient/burst immunity test.
 IEC61000-4-5(2005), Electromagnetic
Compatibility (EMC), Part 4-5: Testing and
measurement techniques. Surge immunity test.
 IEC61000-4-6(2004), Electromagnetic
Compatibility (EMC), Part 4-6: Testing
and measurement techniques. Immunity to
conducted disturbances, induced by radio-
frequency fields.
 IEC61000-4-8(2001), Electromagnetic
Compatibility (EMC), Part 4-8: Testing and
measurement techniques. Power frequency
magnetic field immunity test.
 IEC61000-4-11(2004), Electromagnetic
Compatibility (EMC), Part 4-11: Testing and
measurement techniques. Voltage dips, short
interruptions and voltage variations immunity
test.
 CISPR11(2004), Limits and methods of
measurement of electromagnetic disturbance
characteristics of industrial, scientific and
medical (ISM) radio frequency equipment.
Amendment 1 (1999) Amendment 2 (2002).
 EN45502-1(1998),Active implantable
medical devices. Part 1. General requirements
for safety, marking and information to be
provided by the manufacturer.

Smiths Medical CADD-Solis Specifications

General

Brand	Smiths Medical
Model	CADD-Solis
Category	Medical Equipment
Language	English