2.7 Standards and Regulation
2.7.1 CE Declaration of Conformity
See Appendix 1
2.7.2 21 CFR Part 11 Compliance
Sample Parameter Information and Electronic Records
The P100 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 P100 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 P100 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 P100 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 P100 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 P100 to an external source.
2.8 Warranty
EMTEK, LLC provides a 2-Year Limited Warranty- See Appendix 2
2.9 Calibration
EMTEK and your local area distributor offer calibration services and other options for your P100 Microbial Air
Samplers. A 6 or 12 month (annual) calibration cycle is recommended. Contact EMTEK or your distributor for
calibration questions, service, or options.
To Next Page
Loading...
Need help?
General