Chapter 1. Introduction; Cellometer Ascend Instrument Overview; Intended Use - revvity CELLOMETER ASCEND User Manual

Chapter 1. Introduction

This chapter presents introductory information to be reviewed prior to unpacking your instrument. It includes
Cellometer™ Ascend product and Matrix™ software overviews, lists contents of shipping container, and identifies
symbols/abbreviations used on instrument device label and in this user manual.

CELLOMETER ASCEND INSTRUMENT OVERVIEW

Cellometer Automated Cell Counters incorporate the basic principles of Imaging Cytometry traditionally used in
manual cell counting via hemocytometer into a suite of instruments designed to simplify the cell counting process.
By capturing multiple images of cells to be counted, users can adjust parameters based on cell morphology and
perform reanalysis as necessary. Cellometer Counting Chambers are equivalent to all four corner squares of a
hemocytometer and are disposable, thus saving time and effort, and eliminating any risk of cross-contamination.
Using both Brightfield and Dual-Fluorescent imaging in combination with pattern-recognition software, the
Cellometer Ascend quickly identifies cells and accurately calculates Cell Count, Mean Diameter (micron) and Cell
Concentration (cells/mL). Customizable cell type parameters are designed to assist in the declustering of clumpy cell
lines. For cultured cells stained with trypan blue or fluorescent reagents, the Ascend simultaneously calculates
Live/Dead and Total cell counts, Viability (%), and Live and Total cell concentrations, including a helpful graphic
overlay used to highlight live and dead cells with color-coded outlines in the image being viewed.
The Ascend is an all-in-one standalone instrument offering an integrated touch screen that ensures simple
operation and user-friendly visualization of cell morphology and counted cells. As the built-in computer can be
attached to a network, count results and images can be stored to an external location and an Auto-Print feature can
be enabled to generate a report for each counted sample. Assays allow users to customize counting parameters for
specific cell types and a Cell-size Analysis tool generates histograms enabling optimization of cell diameter settings
(e.g., to exclude debris or exceptionally large cells) during analysis of count results.
An optional Matrix 21 CFR Part 11 module ensures the integrity of your data by limiting access to authorized users,
retaining an audit trail of user transactions, offering electronic signing/unsigning capabilities and providing multi-
layer access control via user roles.

Intended Use

Intended use of the Cellometer Ascend is to count cell lines and primary cells (e.g., total nucleated cells, PBMCs,
splenocytes, hepatocytes, stem cells, tumor/tissue digests, etc.) with the ability to determine cell count, viability
and additional analysis using trypan blue exclusion or fluorescent reagents.
Personnel operating this instrument are encouraged to familiarize themselves with device controls and operation.
Ensure that users can identify all components associated with the instrument, perform adequate adjustments and
understand performance criteria. If issues are encountered, see Chapter 10. Troubleshooting and FAQs on page 47
to restore performance if instrument does not meet or exceed defined performance criteria.
8004708 Cellometer™ Ascend User Manual Rev A 1