Abbott i-STAT Alinity - Page 21

Zambia Zambia Informaon and Communicaons Technology Authority (ZICTA)
Cercate of Type Approval ZMB/ZICTA/TA/2017/4/18 per ICT Act No.
15 of 2009
Zimbabwe Postal & Telecommunicaons Regulatory Authority of Zimbabwe
(POTRAZ)
Cercate of Type Approval No POZ521
SAR / RF Exposure Regulaons:
USA
FCC 47 CFR Part 2 Subpart J - Equipment Authorizaon Procedures,
Secon 2.1093, Radiofrequency Radiaon Exposure Evaluaon: Portable
Devices.
FCC OET-65C: Evaluang Compliance with FCC Guidelines for Human
Exposure to Radiofrequency Electromagnec Fields
Canada Industry Canada RSS 102 Radio Standards Specicaon 102, Radio
Frequency (RF) Exposure Compliance of Radiocommunicaon Apparatus
(All Frequency Bands)
European Union (EU) EN 50360: Product standard to demonstrate the compliance of mobile
phones with the basic restricons related to human exposure to
electromagnec elds (Frequency range of 300 MHz - 3 GHz)
EN 62209-1: Measurement procedure for the assessment of specic
absorpon rate of human exposure to radio frequency elds from hand-
held and body-mounted wireless communicaon devices - Part 1:
Devices used next to the ear (Frequency range of 300 MHz to 6 GHz)
EN 62209-2: Human exposure to radio frequency elds from hand-held
and body-mounted wireless communicaon devices - Human models,
instrumentaon, and procedures - Part 2: Procedure to determine the
specic absorpon rate (SAR) for wireless communicaon devices used in
close proximity to the human body (Frequency range of 30 MHz to 6
GHz)
Environmental Regulaons:
European Union (EU)
RoHS Direcve 2011/65/EU
European Union (EU) WEEE Direcve 2012/19/EU
European Union (EU) REACH Regulaon 1907/2006/EC
European Union (EU) Packaging and Packaging Waste Direcve 94/62/EC
Federal Communicaons Commission (FCC) Statement
(United States only)
xxi
i-STAT Alinity — System Operaons Manual Art: 746983-01 Rev. H Rev. Date: 11-Nov-2020