Specifications; Safety And Regulatory - Abbott Ultiri 1015082 Operation Manual

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Ultiri™ Measurement System Operation Manual – 600327583 Rev. A

Specifications

Safety and Regulatory

Category
Regulatory Approval
Safety Standards
Classifications
Degree of Protection,
Ingress
Flammable Mixtures
Mode of Operation
Leakage Current
Chassis Leakage Current
Specification
European conformity affixed according to the
relevant provisions of EU MDR 2017/745 and
RoHs Directive 2011/65/EU as amended by
2015/863/EU, and Radio Equipment Directive
(RED) 2014/53/EU Annex II. Hereby, Abbott
Medical declares that this device complies with
the essential requirements and other relevant
provisions of these directives.
Abbott Medical hereby declares that Ultiri
Measurement System is in compliance with the
essential requirements and other relevant
provisions of EU MDR 2017/745, RoHs Directive
2011/65/EU as amended by 2015/863/EU, and
RED directive 2014/53/EU. A copy of the Full
Declaration of Conformity can be obtained by
contacting the EU Representative.
CSA C22.2 No. 60601-1: 2014 Ed.3, Medical
electrical equipment Part 1: General
requirements for basic safety and essential
performance
ANSI/AAMI ES60601-1: 2005+A1, Medical
electrical equipment, Part 1: General
requirements for basic safety and essential
performance
Tableside Controller - IPX3
Not for use in presence of flammable anesthetic
mixture with air or with oxygen or nitrous oxide.
Continuous
< 100 µa rms normal condition
< 500 µa rms single-fault condition