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SphygmoCor XCEL - Standards

SphygmoCor XCEL
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Manufacturer
Tonometer
USB
Power Indicator
DC Power Inlet
Power On/Off
Cuff Indicator
Status Indicator
Emergency Stop
Standards
The SphygmoCor XCEL System is designed, tested and approved to the following standards:
Medical electrical equipment -- Part 1: General requirements for safety
IEC/EN 60601-1:1988+A1+A2 (2
nd
Ed.), CSA C22.2 No 601.1-M90 (2003), UL 60601-1 (2003)
IEC/EN 60601-1:2005 (3
rd
Ed.), CSA C22.2 No 60601.1 (2008), ANSI/AAMI ES60601-1 (2005+A2)
Medical electrical equipment -- Part 2-30: Particular requirements for basic safety and essential
performance of automated non-invasive sphygmomanometers
IEC 80601-2-30:2009
Medical electrical equipment -- Part 1: General requirements for safety Section 2. Collateral
Standard: Electromagnetic compatibility - Requirements and tests.
IEC 60601-1-2:2007 This standard requires approval to:
Emissions- CISPR11
Immunity - Electrostatic Discharge (ESD) (IEC 61000-4-2)
Immunity - Radiated RF Electromagnetic Fields (IEC 61000-4-3)
Immunity - Electrical Fast Transient (EFT) Bursts (IEC 61000-4-4)
Immunity - Surges (IEC 61000-4-5)
Immunity - Conducted RF (IEC 61000-4-6)
Immunity - Voltage Dips, Interruptions, Variations (IEC 61000-4-11)
Immunity - Magnetic Fields (IEC61000-4-8)