Test Compliance. Capsa Healthcare TRIO

Warranty

Service Details

Consumable components are not covered under warranty and include:

• Locks and keys

• Document cover

Other standard components will be replaced under the applicable warranty following a filed service request.

Note: the above terms for replacement parts applies to facilities located in the United

States. All other customers should contact the appropriate reseller for the terms of part replacement.

All terms are subject to change without notice.

Standards Compliance

Test Compliance

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NRTL o UL 60601-1 - Issued:2003/04/25 Ed:1 Rev: 2006/04/26 UL Standard for Safety

Medical Electrical Equipment, Part 1: General Requirements for Safety o ANSI/AMMI ES 60601-1:2005/(R)2012 o CAN/CSA C22.2 No. 60601-1-08 (R2014), (Edition 3.1) Medical electrical equipment

- Part 1: General requirements for basic safety and essential performance; COR 2:

2011/06/01 o IEC 60601-1 3rd Edition Medical Electrical Equipment - Part 1-1: General

Requirements for Safety - Collateral Standard: Safety Requirements for Medical

Electrical Systems o IEC/EN 60601-1-2 (Ed. 4th): 2015 - Medical electrical equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility o Conducted Emissions - Conducted Voltages (CISPR 11/ EN 55011 (CV)) o Radiated Emissions - Electric Fields (CISPR 11/ EN 55011 (RE-E)) o Conducted and radiated RF EMISSIONS per CISPR 11; Group 1 Class A product o Harmonic Distortion per IEC 61000-3-2 o Voltage fluctuations and flicker per IEC 61000-3-3 o ESD per IEC 61000-4-2 at ±8kV Contact, ±15kV Air o Radiated RF EM Fields per IEC 61000-4-3 – 3 V/m, 80 Mhz – 2.7 Ghz, 80% AM at 1

Khz o Proximity Fields from RF wireless communications equipment per IEC 61000-4-3 o RATED power frequency magnetic fields per IEC 61000-4-8 at 30 A/m, 50 Hz or

60 Hz o Electrical fast transients / bursts per IEC 61000-4-4 at ±2kV, 100 kHz repetition frequency