i-STAT
Alinity v
— User Manual
650-7100 Rev. A
1
Regulatory Compliance
The i-STAT Alinity system complies with applicable regulations.
Safety Regulations:
USA
UL 61010-1: Safety Requirements for Electrical
Equipment for Measurement, Control and Laboratory
Use – Part 1: General Requirements
Canada
CAN/CSA C22.2 No. 61010-1: Safety Requirements for
Electrical Equipment for Measurement, Control and
Laboratory Use – Part 1: General Requirements
European Union (EU)
IEC 61010-1: Safety Requirements for Electrical
Equipment for Measurement, Control and Laboratory
Use – Part 1: General Requirements
European Union (EU)
IEC 62133: Secondary cells and batteries containing
alkaline or other non-acid electrolytes – Safety
requirements for portable sealed secondary cells, and
for batteries made from them, for use in portable
applications
International
UN Manual of Tests and Criteria “Recommendations on
the Transport of Dangerous Goods,” Section 38.3
“Lithium
Batteries”
EMC Regulations:
USA
FCC 47 CFR Part 15, Subpart B, Class A (Unintentional
Radiators)
Canada
CAN ICES-001 Class A, Industrial, Scientific and
Medical Radio Frequency Radiators
European Union (EU)
IEC 61326-1: Electrical Equipment for measurement,
control and laboratory use – EMC requirements – Part
1:
General
requirements.
Radio/Telecommunication Regulations:
Angola
INACOM Instituto Angolano das Comuinicacoes
Equipment Type Model Number: 189
Antigua & Barbuda
ABTD Antigua & Barbuda Telecommunications
Division
Type Approval Certificate Number 25-TAC2513000853