8004708 Cellometer™ Ascend Matrix User Manual Rev A iii
Table of Contents
CHAPTER 1. INTRODUCTION .................................................................................................... 1
Cellometer Ascend Instrument Overview ................................................................................................ 1
Intended Use ....................................................................................................................................................... 1
Contents of Shipping Container ............................................................................................................... 2
Matrix Software Overview ........................................................................................................................ 2
Matrix 21 CFR Part 11 Module Overview ................................................................................................. 3
About this User Manual ............................................................................................................................ 4
Glossary of Abbreviations ......................................................................................................................... 5
Glossary of Symbols .................................................................................................................................. 6
CHAPTER 2. HAZARDS, SAFETY, AND ENVIRONMENT .............................................................. 7
Potential Hazards...................................................................................................................................... 7
Electrical Hazard .................................................................................................................................................. 7
Instrument System Hazard .................................................................................................................................. 8
Servicing Hazard .................................................................................................................................................. 8
Safety Information .................................................................................................................................... 9
Safety Protocols ................................................................................................................................................... 9
Safety Features .................................................................................................................................................... 9
Environmental Requirements ................................................................................................................. 10
CHAPTER 3. INSTRUMENT DESCRIPTION ................................................................................ 11
Ascend Components ............................................................................................................................... 11
Device SN Label ...................................................................................................................................... 11
Instrument Specifications ....................................................................................................................... 12
Technical Information ............................................................................................................................. 13
Declaration of Conformity ...................................................................................................................... 13
CHAPTER 4. UNPACKING AND SITE PREPARATION ................................................................. 15
Unpacking and Setting Up Instrument ................................................................................................... 15
Site Preparation ...................................................................................................................................... 16
Facility Requirements ........................................................................................................................................ 16
Transporting the Instrument ............................................................................................................................. 16
Disposal of Waste Electrical and Electronic Equipment .................................................................................... 16
Instrument and Software Validation ...................................................................................................... 17
Cellometer Ascend IQ/OQ Validation ................................................................................................................ 17
21 CFR Part 11 OQ Validation ............................................................................................................................ 17
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