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Table 5: Regulatory and Safety Related; Miscellaneous
Symbol
Definition/Use
Authorized representative for Regulatory Affairs in the European Community.
Biological risks
Temperature limitations. The upper and lower limits for storage are adjacent to
upper and lower arms.
Serial number. The serial number will appear adjacent to this symbol.
Catalog number, list number, or reference number. The number adjacent to this
symbol is used to reorder the product.
USB
Do not reuse.
Date of manufacture
Manufacturer
Consult instructions for use or see System Operations Manual for instructions.
Note the following information.
In vitro diagnostic medical device
A mark that indicates conformity to the legal requirements of the appropriate
European Union (EU) Directive(s) with respect to safety, health, environment
and consumer protection.
Signifies that the product bearingt he ETL Listed mark complies with both U.S.
and Canadian product safety standards:
UL 61010-1: 3rd Ed; Am.1
CAN/CSA C22.2 No. 61010-1-12 3rd Ed. (R2017) +U1;U2
Electrical hazard
Attention: See instructions for use.
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i-STAT Alinity — System Operations Manual
Art: 745579-01 Rev. K
Rev. Date: 16-May-2022
Summary of Contents for i-STAT Alinity
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