Revision History (Continued) | xiii
ELx800 Operator's Manual
Revision History (Continued)
L 5/03
(Cont.)
Chapter 4:
- Changed title to "Performance Verification and
IQ/PQ/OQ Tests."
- Added IQ/PQ/OQ test procedure information.
- Clarified procedures for liquid tests.
Replaced outdated Appendix E with instructions for using KCjunior
to read 384-well microplates.
Added new Appendix G with two examples of assay kit instructions
and directions for programming an assay.
Made editorial and formatting changes throughout.
M 9/03 Preface:
- Updated Warnings section (pages vii and viii).
- Updated Electromagnetic Compatibility section (page x).
- Added “Consult instructions for use” and “In vitro diagnostic
medical device” safety symbols (page xii).
- Expanded Intended Use Statement (page xiii).
Added Absorbance Test Plate to Optional Accessories list (Chapter 1,
page 1-8).
Changed callout in Figure 2-2 from “Place unit in bag” to “Unit in
plastic bag” (Chapter 2, page 2-2).
Added KC4 startup information to Appendix E.
Removed references to ELx800UV and EL800UV from Appendix F.
Standardized the presentation of significant digits throughout.
Changed “Abs” to “OD” throughout.
N 10/04 Restructured manual according to new template.
Removed references to “General Formula” throughout.
Updated Chapter 4, Performance Verification and IQ-OQ-PQ
Procedures.
Added new Chapter 5, Maintenance and Decontamination.
Added new Chapter 6, Troubleshooting and Error Codes.
Removed Computer Control portion of Appendix A; renamed
Appendix to “Controlling the Reader With KCjunior™ or KC4™.”
Added new Appendix B, Using 384-Well Geometry.
Updated sample reports in Appendix C, Report Format (formerly
Appendix D).
Removed previous Appendix A, Decontamination.
Removed previous Appendix C, Error Codes.
Added new Appendix E, Instructions for Programming a New Assay.
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