Abbott Afinion 2 - Page 3

AFINION
™
2 User Manual
US | 3
Intended use of the AFINION
™
2 System
Anion 2 System, consisting of the Anion 2 Analyzer and the Anion Test Cartridges, is for in vitro diagnostic use only. Anion 2 Analyzer is a compact multi-assay
analyzer for point-of-care testing and is designed to analyze the Anion Test Cartridges.
CLIA Statements - Waived Anion
™
Tests
Anion HbA1c is waived under the Clinical Laboratory Improvement Amendment of 1988 (CLIA`88). A CLIA Certicate of Waiver is needed to perform testing in a
waived setting.
If the laboratory does not have a Certicate of Waiver, the Application for Certication (Form CMS-116), can be obtained at
https://www.cms.gov/cmsforms/downloads/cms116.pdf.
The form should be mailed to the address of the local State Agency of the State in which the laboratory resides
(https://www.cms.gov/CLIA/12_State_Agency_&_Regional_Ofce_CLIA_Contacts.asp).
If the laboratory modies the Anion Test or Anion 2 Analyzer system instructions, the test no longer meets the requirements for waived categorization. A modied
test is considered to be highly complex and is subject to all applicable CLIA requirements.
Conformity to directives and standards
European IVD directive and RoHS 2 directive (CE marking)
The Anion 2 Analyzer meets all provisions in the Directive 98/79/EC on in vitro diagnostic (IVD) medical devices and in the Directive 2011/65/EU on the restriction
of the use of certain hazardous substances in electrical and electronic equipment (RoHS 2).
North American product safety standards (CNUS mark)
The Anion 2 Analyzer has been tested and found to be in conformity with North American safety standards. See list of safety standards below.
Safety standards
The Anion 2 Analyzer has been tested and found to be in conformity with standards for Safety requirements for electrical equipment for measurement, control, and
laboratory use (IEC 61010-1:2010 , UL 61010-1:2012, CAN/CSA-C22.2: 61010-1 -12) and standard for Particular requirements for in vitro diagnostic (IVD) medical
equipment (IEC 61010-2-101:2015).
EMC standards
The Anion 2 Analyzer has been tested and found to be in conformity with standards for Electrical equipment for measurement, control, and laboratory use
– EMC requirements (EN 61326-1:2013, EN 61326-2-6:2006, EN 61326-2-6:2013 and CFR 47 Telecommunications, Chapter I- FCC Part 15 – Radio Frequency
Devices – Subpart B: unintentional radiators).