ChemoMetec NucleoCounter NC-200 User manual

NucleoCounter®NC-200™
Instrument User's Guide
P/N 991-0203
Revision 1.3
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NucleoCounter NC-200™
Flexible Cell Counter
P / N 9 9 1 - 0 2 0 3 ( E n g l i s h )
R e v i s i o n 1 . 3
M a y , 2 0 1 4
ChemoMetec A/S
Gydevang 43, DK-3450 Allerod, Denmark
Telephone: [phone], Fax: [phone]
Internet: www.chemometec.com,
E-mail: [e-mail]
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Caution!
This equipment must be operated as described in this User’s Guide and documents referred to herein. Please
read the entire guide and referred documents before attempting to use this unit. Please pay attention to that
gloves or protective clothing are not worn on the illustrations/pictures shown in this User’s Guide. However,
ChemoMetec A/S does recommend that the user wear suitable protective clothing et c.
Contacting support
Technical information including product literature, answers to questions regarding the operation of the
NucleoCounterNC-200™ not covered in this document and referred documents is available through the
following:
For e-mail support, send questions to NucleoCounter NC-200™ Technical Support on the address
[e-mail]
Check out the FAQ section under support at www.chemometec.com
To speak with a Technical Support Specialist, call ([phone].
Please note the NucleoCounterNC-200™ serial number and have it available when contacting ChemoMetec
A/S for support. The NucleoCounterNC-200™ serial number is found on the label affixed to the bottom of the
instrument. The version number of the NucleoView NC-200™ software shall also be noted, this can be found on
the Help –About menu item in the NucleoView NC-200™ software.
Sales and ordering information
For sales assistance with NucleoCounterNC-200™ or the NucleoView NC-200™ software, to place an order for
a NucleoCounterNC-200™ or consumables, call ([phone], fax [phone], or send e -mail to
[e-mail]
Disclaimer Notices
The material in this document and referred documents is for information only and is subject to change without
notice. While reasonable efforts have been made in preparation of these documents to assure their accuracy,
ChemoMetec A/S assumes no liability resulting from errors or omi ssions in these documents, or from the use
of the information contained herein.
ChemoMetec A/S reserves the right to make changes in the product design without reservation and without
notification to its users.
Copyright Notices
Copyright © ChemoMetec A/S 2 011. All rights reserved. No part of this publication and referred documents
may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic,
mechanical, photocopying, recording or otherwise, without the prior written consent of Che moMetec A/S,
Gydevang 43, DK-3450 Allerod, Denmark.
ChemoMetec and NucleoCounter are registered trademarks owned by ChemoMetec A/S. NucleoCounter,
NucleoCassette, Via1-Cassette and NucleoView are trademarks of ChemoMetec A/S.
All other trademarks are the p roperty of their respective owners.
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Declaration of Conformity
991-0203 Rev. 1.3 May 2014 vii
Declaration of Conformity
Name of product: NucleoCounterNC-200™
Type: Flexible Cell Counter
Other identifying data: Part no. 900-0201
We declare under our sole responsibility that the products, to which this declaration
relates, are in conformity with the Council Directives on the approximation of the laws of
the EEC Member States relating to the following:
Directives
Electromagnetic Compatibility (2004/108/EC). EMC
Low Voltage Directive (2006/95/EC) LVD
Machinery Directive (2006/42/EC) MD
Standards
EMC:
EN 61326-1:2006 Electrical equipment for laboratory use
EN 61000-3-2: 2006 Limits for harmonic current emissions
EN 61000-3-3: 1995 +A1 +A2: 2005 Limitation of voltage changes, voltage
fluctuations and flicker
Standards
LVD:
EN 61010-1:2001 Safety requirements for electrical equipment for
measurement, control, and laboratory use
Standards
MD:
EN 12100-1: 2003 Safety of machinery; Basic concepts, general principles
for design —Part 1
EN 12100-2: 2003 Safety of machinery; Basic concepts, general principles
for design —Part 2:
EN ISO 14121-1:2007 Safety of machinery; risk assessment
This device complies with Part 15 of the FCC Rules. Operation is subject to the following
two conditions: (1) this device may not cause harmful interference, and (2) this device
must accept any interference received, including interference that may cause undesired
operation.
Date: 2011-July-1st Signed:
Name: Sarah R. Rasmussen
Position: QA/QC Manager
Name and address of manufacturer:
ChemoMetec A/S
Gydevang 43
DK-3450 Allerod
DENMARK
www.chemometec.com
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WEEE directive information –Europe only
991-0203 Rev. 1.3 May 2014 ix
WEEE directive information –Europe only
Correct Disposal of This Product
(Waste Electrical & Electronic Equipment) - Europe only
This marking shown on the product or its literature, indicates that it should
not be disposed together with other household wastes at the end of its
working life. To prevent possible harm to the environment or human health
from uncontrolled waste disposal, please separate this from other types of
wastes and recycle it responsibly to promote the sustainable reuse of
material resources.
Business users should contact their supplier and check the terms and
conditions of the purchase contract. This product should not be mixed with
other commercial wastes for disposal.
This information is listed in “Appendix B: WEEE directive information in
more EU languages”.
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WEEE directive information –Europe only
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Introduction and intended use
991-0203 Rev. 1.3 May 2014 xi
Introduction and intended use
The NucleoCounter® NC-200™ is a compact cell-counter intended to be used for precise
cell counting within the life-science and pharmaceutical markets. The NucleoCounter® NC-
200™ system is intended for research use only, not for diagnostic use. The NucleoCounter®
NC-200™ uses disposable cassettes from ChemoMetec A/S.
The NucleoCounter® NC-200™ is a highly advanced cell counter based on fluorescence
microscopy using CMOS camera technology with low magnification and advanced image
analysis. Different properties of the individual cells can be analyzed with the 3 integrated
light sources (365nm, 500nm and dark field) and with 2 emission bands. Spatial position is
maintained from filter to filter enabling direct comparison of the different parameters
detected or quantified on each individual cell. The low magnification (x1.3) guarantees a
high analysis volume and thus ensures a high statistical performance.
Specially designed sample illumination ensures homogeneous illumination at the complete
measuring area and thereby accurate quantification of fluorescence signal is achieved.
Since no tubes, valves, hoses etc. are present the instrument is virtually service and
maintenance free.
The NucleoCounter® NC-200™ is improved in relation to NucleoCounter® NC-100 and
shares some of the strong features with the NucleoCounter® NC-3000. In normal viability
analysis the sample volume is as high as 1.4 µl and the ability to detec t cells in clusters is
also available.
The NucleoCounter® NC-200™ part number at ChemoMetec A/S is 900-0201.
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Introduction and intended use
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Warnings and precautions
991-0203 Rev. 1.3 May 2014 xiii
Warnings and precautions
Whenever the symbol appears on the NucleoCounter® NC-200™ instrument, it
indicates that the manual must be consulted for precautions and warnings.
Power and cables
Use the shielded USB cable supplied with the NucleoCounter® NC-200™ to ensure that
appropriate EMI classification is maintained for the intended environment.
The USB interface connector of the NucleoCounter® NC-200™ must only be connected
to SELV circuits. External computing devices connected to the USB interface connector of
the NucleoCounter® NC-200™ have to comply with the standards, UL 1950 and IEC/EN
60950.
Table 1 Description of the NucleoCounter® USB interface connector
NucleoCounter® NC-200™ is powered by an external 24VDC power supply. For safe use,
please follow the instructions for connecting the power supply.
The NucleoCounter® NC-200™ shall only be used with an external power supply
purchased at ChemoMetec A/S.
The detachable DC power supply cord set and appliance inlet of the external power
supply are considered as the disconnecting device.
The mains supply cord and plug of the external power supply shall comply with any
national regulations.
The user should be made aware of that, if the NucleoCounter® NC-200™ and the
external power supply are used in a manner not specified by the manufacturer, the
1In normal operation mode (refers to Pin no 4)
Pin no.
Name
Maximum
Voltage level1
1
+5V
+5
VDC
2
D-
+3.5
VDC
3
D+
+3.5
VDC
4
DGND
0
VDC
Metal
enclosure
Shield
(connected
to DGND)
0
VDC
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Warnings and precautions
991-0203 Rev. 1.3 May 2014 xiv
protection provided by the NucleoCounter® NC-200™ and the external power supply may
be impaired.
Electromagnetic interference
NOTE: This equipment has been tested and found to comply with the limits for a Class B
digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a residential installation. This
equipment generates, uses and can radiate radio frequency energy and, if not installed and
used in accordance with the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not occur in a
particular installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment off and on, the
user is encouraged to try to correct the interference by one or more of the following
measures:
Reorient or relocate the receiving antenna.
Increase the separation between the equipment and receiver.
Connect the equipment to an outlet on a circuit different from that to which the
receiver is connected.
Consult the dealer or an experienced radio/TV technician for help.
Caution! Changes or modifications not expressly approved by the party responsible for
compliance could void the user's authority to operate the equipment.
Cassettes, Reagents, Solutions and Dispensers
With respect to use and handling of cassettes, reagents, solutions and dispensers, please
refer to appropriate package inserts for these items.
Caution! When using a bottle-top dispenser: To protect against accidental splashes,
protective clothing, eye protection and gloves must be worn when using potentially
hazardous liquids.
General
Any biological specimen should be handled, as if it is capable of transmitting infectious
disease and disposed of with proper precautions according with federal, state and local
regulations.
Avoid specimen contact with skin or mu cous membranes.
Never pipette by mouth.
Avoid cross contamination of the samples when preparing the samples. This can
compromise the quality of the results.
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Warnings and precautions
991-0203 Rev. 1.3 May 2014 xv
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Table of contents
991-0203 Rev. 1.3 May 2014 1
Table of contents
DECLARATION OF CONFORMITY ......................................................................................VII
WEEE DIRECTIVE INFORMATION –EUROPE ONLY .............................................................. IX
INTRODUCTION AND INTENDED USE ................................................................................ XI
WARNINGS AND PRECAUTIONS ...................................................................................... XIII
1INSPECTION, UNPACKING AND INSTALLATION OF EQUIPMENT .................................... 3
1.1 OPERATION OF THE NUCLEOCOUNTER®NC-200™. ......................................................... 3
2CELL COUNTING WITH THE NUCLEOCOUNTER® NC-200™ ............................................. 5
2.1 THE NUCLEOCOUNTER®NC-200™ INSTRUMENT ............................................................ 5
2.1.1 Fluorescence microscope .............................................................................. 6
2.1.2 The Cassette fixture...................................................................................... 6
2.1.3 The RUN Key and LED indicator. .................................................................... 6
2.2 THE CASSETTE ........................................................................................................ 7
2.2.1 Loading the Cassette .................................................................................... 7
2.2.2 Sample volume ............................................................................................. 8
2.2.3 Cassette handling ......................................................................................... 8
3KEY, LED INDICATOR A ND PC CONTROL ....................................................................... 9
3.1 INTERACTIVE CONTROLS ............................................................................................ 9
4START-UP ................................................................................................................ 11
4.1 POWER ON,POWER OFF .......................................................................................... 11
4.1.1 Starting up ................................................................................................. 12
5OPERATION OF THE NUCLEOCOUNTER® .................................................................... 13
5.1 READY MODE ....................................................................................................... 13
5.2 ANALYSIS WITH THE CASSETTES ................................................................................. 13
5.2.1 Actuator movements .................................................................................. 14
5.3 RESULT PRESENTATION ........................................................................................... 14
5.4 PROTECTION OF THE OPTICAL SYSTEM ......................................................................... 14
6NUCLEOVIEW NC-200™ ............................................................................................ 15
7MAINTENANCE OF NUCLEOCOUNTER® NC-200™ ....................................................... 17
7.1 CLEANING ........................................................................................................... 17
7.1.1 Instrument enclosure. ................................................................................. 17
7.1.2 Cassette fixture .......................................................................................... 17
7.1.3 Spill of liquid .............................................................................................. 18
7.2 DECONTAMINATION ............................................................................................... 18
8PC- MAINTENANCE, ERROR MESSAGES AND POWER-ON FAILURE............................... 19
8.1 REQUIRED HARD DISK SPACE FOR DATA STORAGE. .......................................................... 19
8.2 ERROR MESSAGES .................................................................................................. 19
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Table of contents
991-0203 Rev. 1.3 May 2014 2
8.3 POWER-ON FAILURE ............................................................................................... 19
9TECHNICAL SPECIFICATIONS ..................................................................................... 21
9.1 THE NUCLEOCOUNTER®NC-200™............................................................................ 21
9.2 SAMPLE MEDIAS .................................................................................................... 21
9.3 EU STANDARDS..................................................................................................... 22
10 EQUIPMENT AND ACCESSORIES ............................................................................. 23
APPENDIX A: DESCRIPTION OF CHANGES FROM LATEST REVISION .................................... 25
APPENDIX B: WEEE DIRECTIVE INFORMATION IN MORE EU LANGUAGES ........................... 27
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1 Inspection, Unpacking and Installation of Equipment
991-0203 Rev. 1.3 May 2014 3
1Inspection, Unpacking and Installation of
Equipment
Upon receiving the order from ChemoMetec A/S, the box or boxes should be carefully
inspected for any damage that may have occurred during shipping. Any damage must be
reported to the carrier and to ChemoMetec A/S immediately.
Unpack the order, saving the packing materials for possible later use.
Verify that the ChemoMetec packing list received refers to the correct and ordered
materials, and that nothing is missing.
If any part of the order was damaged during shipping , is missing, or fails to operate, please
contact ChemoMetec A/S.
The document supplied with the instrument2:
NucleoCounter_NC_200_IQ.pdf
This document describes in details how to inspect, unpack and install the NucleoCounter®
NC-200™ instrument and the NucleoView NC-200™ software. This IQ will also ensure that
the instruments basic functions respond correctly.
1.1 Operation of the NucleoCounter® NC-200™.
Before starting to use the NucleoCounter® NC-200™, it is important to refer to the
following document:
NucleoCounter_NC_200_IQ.pdf
This document presents a procedure which, upon successful completion, will assure that
the advanced functions of the instrument are executed correctly.
Once the IQ and the OQ are finalized successfully, actual operation with the
NucleoCounter® NC-200™ can begin.
2This document is present on the USB Flash drive in the DATA folder supplied with the
instrument
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2 Cell counting with the NucleoCounter® NC-200™
991-0203 Rev. 1.3 May 2014 5
2Cell counting with the NucleoCounter® NC-200™
The NucleoCounter® NC-200™ is a bi-color fluorescent cell-counting instrument. The
NucleoCounter® has the advantage that only short training time is required before the
user can run highly advanced cell counting protocols. The instrument itself is calibration
free. The individual calibration parameter for a cassette will be read and used by the
instrument during analysis.
The complete list of protocols is shown in the document; Protocol list for the
NucleoCounter® NC-200™. This covers protocols such as:
Count of Aggregated Cells Assay
Viability and Cell Count –Aggregated Cells Assay
Viability and Cell Count Assay
New protocols will be developed on an on-going basis and the updated list can be seen at
the web site: www.chemometec.com
2.1 The NucleoCounter® NC-200™ instrument
The NucleoCounter® NC-200™ is shown in the figure below.
Figure 1 NucleoCounter® NC-200™
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