Abbott OPTIS 1014933 - System Specifications; System - Safety and Regulatory

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OPTIS™ Integrated Next Operation and Maintenance Manual – 600173796 Rev. A
System Specifications
System - Safety and Regulatory
Table 2. System Safety and Regulatory Specifications
Category Specifications
Regulatory Approvals
US 510(k) clearance
European conformity, affixed according to the relevant provisions of EU MDR 2017/745 and
2011/65/EU, and RED directive 2014/53/EU Annex II. Hereby, Abbott Medical declares that this device
complies with the essential requirements and other relevant provisions of these directives.
The OPTIS Integrated Next complies with FDA performance standards for laser products except for
deviations pursuant to laser Notice No. 50, dated June 24, 2007.
Abbott Medical hereby declares that OPTIS Integrated Next is in compliance with the essential
requirements and other relevant provisions of EU MDR 2017/745, 2011/65/EU, and RED directive
2014/53/EU. A copy of the Full Declaration of Conformity can be obtained by contacting the EU
Representative.
Safety Standards
IEC 60601-1:2005/A1:2012 (per Annex ZZ) Medical electrical equipment Part 1: General
requirements for basic safety and essential performance
CAN/CSA C22.2 No. 60601-1:2008, Medical electrical equipment Part 1: General
requirements for basic safety and essential performance
IEC 60825-1, 3rd Ed., 2014 Safety of Laser Products
Part 1: Equipment classification and requirements
IEC 60601-1-2:2014 Ed.4 Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance - Collateral standard:
Electromagnetic compatibility - Requirements and tests – Group 1 Equipment,
Class A
ANSI/AAMI ES60601-1:2005/(R)2012, Medical electrical equipment, Part 1: General
requirements for basic safety and essential performance
Environmental
RoHS Directive 2011/65/EU
REACH Directive EC 1907/2006
WEEE Directive 2012/19/EU
Electromagnetic Compatibility (EMC)
Refer to Electromagnetic Emission and Electromagnetic Immunity for detailed specifications.
Classifications
Type of Protection, Shock
Class 1
Degree of Protection, Shock
Type CF, De-fib proof
DOC with catheter (CF, De-fib-proof label at catheter connection point)
Degree of Protection, Ingress
System Cabinet - IPX0
DOC - IPX0, use with Sterile DOC cover for ingress protection
Tableside Controller - IPX3
DOC Holster - IPX0
Note: The 27 m remoting cable connection to DOC Holster is rated for IP54.
Method of Disinfection
System Cabinet and DOC will withstand without damage or deterioration disinfection by wiping with
common hospital disinfectants, including Cidex
‡
(Glutaraldehyde 3.4%).
Flammable Mixtures
Not for use in presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide.
Mode of Operation
Continuous
State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release