System Specifications; System - Safety And Regulatory - Abbott OPTIS 1014933 Operation And Maintenance Manual

State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release
Table 2. System Safety and Regulatory Specifications
Category
Regulatory Approvals
Safety Standards
Environmental
Electromagnetic Compatibility (EMC)
Classifications
Type of Protection, Shock
Degree of Protection, Shock
Degree of Protection, Ingress
Method of Disinfection
Flammable Mixtures
Mode of Operation
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OPTIS™ Integrated Next Operation and Maintenance Manual – 600173796 Rev. A

System Specifications

System - Safety and Regulatory

Specifications
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.
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
RoHS Directive 2011/65/EU
REACH Directive EC 1907/2006
WEEE Directive 2012/19/EU
Refer to Electromagnetic Emission and Electromagnetic Immunity for detailed specifications.
Class 1
Type CF, De-fib proof
DOC with catheter (CF, De-fib-proof label at catheter connection point)
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.
System Cabinet and DOC will withstand without damage or deterioration disinfection by wiping with
common hospital disinfectants, including Cidex
Not for use in presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide.
Continuous
‡
(Glutaraldehyde 3.4%).