HA-8180V i
1Premise
Thank you for purchasing our automatic glycohemoglobin analyzer, ADAMS
TM
A1C HA-8180V.
This operating manual contains important information on the functions of the ADAMS A
1C HA-8180V.
This operating manual is issued by ARKRAY, Inc.
Read carefully prior to starting up the unit.
It is recommended to retain this operating manual for future use.
Intended Purpose
The ADAMS A1c HA-8180V instrument is intended for the quantitative and automated measurement of
HbA1c in whole blood and hemolysis samples. HbA1c measurements are used for screening, monitoring
and as an aid to diagnosis of diabetes and prediabetes, for individuals diagnosed with or at risk of
developing diabetes or prediabetes. For in vitro diagnostic use and professional use only.
This product conforms to the EMC Standard IEC61326-2-6:2012.
Class of emission: CISPR 11 Class A
This instrument is an IVD medical instrument.
This product conforms to Regulation (EU) 2017/746.
This instrument has been tested and found to comply with the limits for a Class A digital device, pursuant
to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful
interference when the instrument is operated in a commercial environment. This instrument generates,
uses, and can radiate radio frequency energy and, if not installed and used in accordance with the operating
manual, may cause harmful interference to radio communications.
Operation of this instrument in a residential area is likely to cause harmful interference in which case the
user will be required to correct the interference at his own expense.
The electromagnetic environment should be evaluated prior to operation of the device. Do not use this
device in close proximity to sources of strong electromagnetic radiation, as these may interfere with the
proper operation.
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