Chapter 12: Specifications/Limitations
12-5
Questions? Refer to Page 10-9 For Technical Support Instructions.
Standards Compliance
e Precision Xceed Pro Point of Care System has been evaluated against the following standards:
UL 60601-1, 1st ed. Medical Electrical Equipment—Part 1: General Requirements for Safety
CSA C22.2 No. 601.1-M90, Medical Electrical Equipment - Part 1: General Requirements for Safety
EN 60601-1, 2nd ed., Medical Electrical Equipment—Part 1: General Requirements for Safety
CSA 22.2 No. 61010.1-4
EN 60601-1 - Medical Electrical Equipment Part 1: General Requirements for Safety Incorporates Corrigendum July
1994; Includes Amendments A1: 1993, A11: 1993, A12: 1993, A2: 1995 and A13: 1996; IEC 601-1: 1988 + A1: 1991
+ A2: 1995 + Corrigendum 1995, Modified
IEC 61010-2-101 (2002-01) - Safety Requirements for Electrical Equipment for Measurement, Control, and
Laboratory Use Part 2-101: Particular Requirements for In Vitro Diagnostic (IVD) Medical Equipment First Edition
EN 60601-1-2 - 2001 Class A - Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral
Standard: Electromagnetic Compatibility - Requirements and Tests IEC 60601-1-2: 2001
IEC 60601-1 - Medical Electrical Equipment Part 1: General Requirements for Safety Second Edition
IEC 60601-1-1, 2nd ed., Medical Electrical Equipment - Part 1-1: General requirements for safety - Collateral stan-
dard: Safety requirements for medical electrical systems
IEC 60601-1-2 (1993-04) - Medical Electrical Equipment Part 1: General Requirements for Safety 2. Collateral
Standard: Electromagnetic Compatibility - Requirements and Tests First Edition; (CENELEC EN 60601-1-2: 1993)
Precision Xceed Pro Monitor – Class II (EQUIPMENT energized from an internal electrical power source).
Docking Station – Class II (EQUIPMENT energized from an internal electrical power source).
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