Cedex HiRes User Manual

6
Cedex HiRes Analyzer Software Version 2.4 - Training Guide
II Contact Addresses
Manufacturer Roche Diagnostics GmbH
Sandhofer Straße 116
68305 Mannheim
Germany
Distribution Roche Diagnostics GmbH
Sandhofer Straße 116
68305 Mannheim
Germany
Distribution in USA Roche Diagnostics
9115 Hague Road
Indianapolis, Indiana
III. Declaration of Conformity
Instrument
approvals
The Cedex HiRes Analyzer meets the protection requirements laid down in:
c
Directive 2014/30/EU of the European Parliament and Council of 26. February 2014 relating to
electromagnetic compatibility (EMC).
c
Directive 2014/35/EU of the European Parliament and Council of 26. February 2014 relating to
electrical equipment designed for use within certain voltage limits.
c
Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the
restriction of the use of certain hazardous substances in electrical and electronic equipment.
Compliance with the applicable directive(s) is provided by means of the Declaration of Conformity.
Regulatory compliance is demonstrated by the following marks:
c Complies with the provisions of the applicable EU directives.
c RoHS (Restriction of Hazardous Substances) compliant from Serial No. G037E0001.
Issued by Underwriters Laboratories, Inc. (UL) for Canada and the US. ‘Laboratory Equipment’ is
the product identifier as shown on the type plate.
IV Intended Use
The Cedex HiRes Analyzer automatically determines the cell concentration and viability of cell suspensions. It
must be used exclusively by laboratory professionals who are trained in laboratory techniques and have studied
the Instructions for Use of this system.
The Cedex HiRes Analyzer is for use in quality control/manufacturing process only.
It was neither developed nor validated by the manufacturer for any kind of in vitro diagnostic application.
V Preamble
Before setting up operation of the Cedex HiRes Analyzer, it is important to read this User Training Guide and
the Cedex HiRes Analyzer Operator’s Guide thoroughly and completely. Non-observance of the instructions
contained herein or performing an operation not stated in this Training Guide could cause safety hazards.
Contact Addresses

Cedex HiRes Specifications

General

Viability Range	0 - 100%
Concentration Range	5 x 10^4 to 1 x 10^7 cells/mL
Measurement Principle	Image analysis
Cell Types	Mammalian cells
Measurement Parameters	Total cell count, viable cell count, viability
Measurement Time	Typically < 1 minute
Power Requirements	100-240 V, 50/60 Hz
Interface	USB and Ethernet
Operating Temperature	15-30°C
Operating Humidity	20-80% (non-condensing)