EMTEK, LLC - R100 USERS MANUAL / AUG2019.REV01
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2.7 Standards and Regulation
2.7.1 21 CFR Part 11 Compliance
Sample Parameter Information and Electronic Records
The R100 Central Processing Unit (CPU) stores sample parameter information for up to 500 sample runs in the
internal memory. This memory is not removable or alterable by the user. The sample parameter information
maintained in the system for each run includes: Serial#, Equipment#, Building/Room (if entered through PC
software), Start Date, Start time, End time, Average Flow, Total Volume, Total Run Time, Delay (duration), Hold
(duration), Sample (duration), User ID, Run ID (system generated), Site (ID), Hi Flow (duration), and Low Flow
(duration). The stored sample parameters can be cleared/deleted by the user (if allowed through Admin control), or
administrator, but cannot be edited. Further, sample parameter information of a specific sampling event cannot be
selectively deleted or altered by the user. The R100 can re-print sample parameter information using the optional
thermal printer. The user can select the number of previous samples to be printed.
The sample parameter information stored in the internal memory of the R100 controller can be either printed to the
optional thermal printer, output to a USB stick for further transfer, or transferred to an external computer through
an Ethernet connection and optional PC based software. The sample parameter information can be deleted but
cannot be altered while residing within the internal memory of the R100 CPU. This sample parameter information
may be exported from the internal memory. EMTEK, LLC does not provide software utilities to comply with the
requirements of 21 CFR Part 11 after the data is transferred from a R100 controller to an external source. Users that
are subject to FDA regulations are responsible for maintaining compliance with 21 CFR Part 11 after the data is
transferred from the R100 to an external source.
2.8 Warranty
EMTEK, LLC provides a 2-Year Limited Warranty- See Appendix E
2.9 Calibration
EMTEK and your local area distributor offer calibration services and other options for your R100 Microbial Air
Samplers. A 6 or 12 month (annual) calibration cycle is recommended. Contact EMTEK or your distributor for
calibration questions, service, or options.