Chemometec NC-202 User Manual

NucleoCounter® NC-202
P/N 991-2020
Revision 1.1
November 2019
ChemoMetec A/S
Gydevang 43 · DK-3450 Allerød · Denmark
Telephone: (+45) 48 13 10 20
Website: www.chemometec.com
E-mail: contact@chemometec.com
991-2020 Rev. 1.0 May 2019
ii
Caution!
This equipment must be operated as described in this user guide and documents referenced herein. Please read the entire guide and referenced documents before using the NucleoC ounter® NC-202. Gloves or protective clothing may not be shown in the pictures in this user guide; however, ChemoMetec recommends that the user wear suitable p rotect ive clothing.
Contacting Support
Technical information including product literature, answers to questions not covered in this document and referred documents regarding the operat ion of the NucleoCounter NC-202 is available from our support team:
E-mail questions to support@chemometec.com
To speak with a Technical Suppo rt Specialist, c all (+45) 48 13 10 20
Please create support files in NC-View via Help Create s upport files , before contacting us.
Sales and Ordering Information
To order the NucleoCounter NC- 202, NC-View software and consumables, call (+45) 48 13 10 20, fax (+45) 48 13 10 21, or e-mail sales@chemometec.com .
Disclaimer Notices
The material in this document and referred do cuments is for information o nly and is s ubject to cha nge withou t notice. While rea sonable efforts have b een made in preparation of these documents to ensure their accuracy, ChemoMetec as sumes no liability resul ting from errors or omi ssions in these documents, or from the use of the information con tained herein.
ChemoMetec rese rves the r ight to make changes i n the product design w ithout res ervation a nd without notification to its users.
Copyright Notices
Copyright © ChemoMetec A/S 2019. All rights reser ved including graphics and images. No part of th is publication, software and referred do cuments may be reproduce d, stored in a retriev al system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior written consent of ChemoMetec A/S , Gydevang 43, DK-3450 Allerod, Denmark.
ChemoMetec® and NucleoCounter ® are registered trademarks owned by ChemoMetec. NucleoCassette, Via2­Cassette and NC-View are trademarks of ChemoMetec.
All other trademarks are th e property o f their respective own ers.
Declaration of Conformity
991-2020 Rev. 1.1 November 2019 iii
Declaration of Conformity
Name of product: NucleoCounter NC-202 Type: Automated Cell Counter Other identi fy ing data: Part no. 900-2020
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 (2014/30/EU) EMC Low Voltage Directive (2014/35/EC) LVD Machinery Directive (2006/42/EC) MD
Standards EMC:
EN 61326-1:2013 Electrical equipment for laboratory use EN 61000-3-2: 2014 Limits for harmonic current emissions EN 61000-3-3: 1995 +A1 +A2: 2013 Limitation of voltage changes, voltage fluctuations and flicker
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: i) this device may not cause harmful interference; and ii) this device must accept any interference received, including interference that may cause undesired operation.
Date: 2019-April-12th Signed:
Name: Eva Louise Lange
Position: Quality Manager
Name and address of manufacturer:
ChemoMetec A/S Gydevang 43 DK-3450 Allerod DENMARK www.chemometec.com
WEEE Directive Information – Europe Only
991-2020 Rev. 1.1 November 2019 iv
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 of 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 sh ould not be mixed with other commercial wastes for disposal.
This information is listed in “ Appendix A: WEEE Directive Information in More EU Languages”.
Introduction and Intended Use
991-2020 Rev. 1.1 November 2019 v
Introduction and Intended Use
The NucleoCounter® NC-202 is a compact, automated cell counter intended for cell counting within the life science and pharmaceutical markets. The NucleoCounter® NC-202 system is intended for research use only, not for diagnostic use. The NucleoCounter® NC-202 uses disposable cassettes from ChemoMetec.
The NucleoCounter® NC-202 is an advanced cell counter based on low magnification fluorescence microscopy using LED light and CMOS camera technology, combined with automated image analysis. Cells are analyzed using two fluorescence channels, where the spatial position is maintained between images, allowing direct comparison and quantification of parameters at single cell level. Low magnification (×2.1) and a large sensor area (2/3”) facilitate a high volume of analytical samples, thereby providing great statistical performance. The NucleoCounter® NC-202™ light sources deliver homogeneous sample illumination, which reduces systematic errors in fluorescence signal intensities across the measurement area and increases the accuracy of cell counting values.
The NucleoCounter® NC-202™ requires NC-View software to operate. NC-View is distributed with a list of protocols employing two fluorescence channels to analyze cells. Instrument qualification protocols are included in the software.
The NucleoCounter® NC-202™ uses Via2-Cassettes, which contain fluorescent dyes and allow the NucleoCounter® NC-202™ to detect cells. The NucleoCounter® NC-202 is the third generation of NucleoCounter® cassette instruments, succeeding the NucleoCounter® NC-100 and NucleoCounter® NC-200.
The NucleoCounter® NC-202 ChemoMetec part number is 900-2020.
Warnings and Precautions
991-2020 Rev. 1.1 November 2019 vi
Warnings and Precautions
Whenever the symbol appears on the NucleoCounter® NC-202 instrument, it indicates that the manual must be consulted for precautions and warnings.
Power Supply and Cables
Use the shielded USB cable supplied with the NucleoCounter® NC-202 to ensure that appropriate EMI classification is maintained for the intended environment.
The USB interface connector must only be connected to SELV circuits. Ext ernal
computing devices connected to the USB interface connector of the NucleoCounter® NC­202™ must comply with standards UL 1950 and IEC/EN 60950.
Table 1: Description of the NucleoCounter® NC-202™ USB 3.0 micro interface connector
The NucleoCounter® NC-202 is powered by an external 24VDC power supply. For safe use, please follow the instructions for connecting the power supply.
The NucleoCounter® NC-202 should only be used with an external power supply
purchased from ChemoMetec.
The detachable DC power supply cable set and the appliance inlet of the external
power supply are considered as the disconnecting device.
The main supply cable and plug of the external power supply should comply with any
national regulations.
The user is made aware that if the NucleoCounter® NC-202 and the external power
supply are used in a manner not specified in this user guide, the protection may be impaired.
1
In normal operation mode (refers to Pin no 5 and/or 8)
Pin
Pin Name
Pin Description
Maximum Voltage level1
1
VBUS
+5V
+5 VDC
2
USB D-
USB 2.0 differential pair
+3.5 VDC
3
USB D+
USB 2.0 differential pair
+3.5 VDC
4
OTG ID
USB OTG ID for identifying lines
5 GND
Ground
0 VDC
6
USB3 SSTX-
USB 3.0 signal transmission line
7 USB3 SSTX+
USB 3.0 signal transmission line
8 GND
Ground
9 USB3 SSRX-
USB 3.0 signal receiving line
10
USB3 SSRX+
USB 3.0 signal receiving line
Warnings and Precautions
991-2020 Rev. 1.1 November 2019 vii
Electromagnetic Interference
NOTE: This equipment has been tested to meet the Class B digital device limits, 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 any given 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 the receiver
connection
Consult the dealer or an experienced radio/TV technician for help
Caution! Changes or modifications not expressly ap proved by the party responsible for compliance could void the user's authority to operate the equipment.
Cassettes, Reagents, Solutions and Dispensers
With respect to the use and handling of cassettes, reagents, solutions and dispensers, please refer to appropriate package inserts for these items.
Caution! Bottle-top dispenser: To protect against accidental spills, protective clothing, eye protection and gloves must be worn when using potentially hazardous liquids.
General Precautions
Any biological specimen should be handled as if capable of transmitting infectious disease s and disposed of with proper precautions according with national, federal, state and local regulations.
Avoid specimen contact with skin or mucous membranes.
Never pipette by mouth.
Avoid cross contamination of samples during preparation. This can compromise the quality of results.
Table of Contents
991-2020 Rev. 1.1 November 2019 1
Table of Contents
DECLARATION OF CONFORMITY ....................................................................................... III
WEEE DIRECTIVE INFORMATION – EUROPE ONLY .............................................................. IV
INTRODUCTION AND INTENDED USE ................................................................................. V
WARNINGS AND PRECAUTIONS ........................................................................................ VI
1 INSPECTION, UNPACKING AND INSTALLATION OF EQUIPMENT .................................... 3
1.1 INSTALLATION AND OPERATION QUALIFICATION OF NUCLEOCOUNTER® NC-202™ .................. 3
2 CELL COUNTING WITH NUCLEOCOUNTER® NC-202™ .................................................... 4
2.1 THE NUCLEOCOUNTER® NC-202™ INSTRUMENT ............................................................ 4
2.1.1 Fluorescence microscope .............................................................................. 4
2.1.2 Protocols ..................................................................................................... 4
2.1.3 The RUN button and LED indicator ................................................................ 5
2.1.4 Cassette fixture ............................................................................................ 5
2.1.5 USB 3 connection ......................................................................................... 5
2.2 THE VIA2-CASSETTE .............................................................................................. 6
2.2.1 Loading the Via 2-Cassette™ cassette ............................................................ 6
2.2.2 Via2-Cassette™ volume calibration dot code ................................................. 7
2.2.3 Cassette handling ......................................................................................... 7
3 NUCLEOCOUNTER® NC-202™ – INSTRUMENT CONTROLS ............................................. 8
3.1 INTERACTIVE CONTROLS ............................................................................................ 8
3.2 NUCLEOCOUNTER® NC-202™ CONNECTIONS ................................................................ 9
3.2.1 NC-202™ power connection .......................................................................... 9
3.2.2 USB connection and initialization ................................................................ 10
4 OPERATION OF NC-VIEW™ SOFTWARE AND NUCLEOCOUNTER® NC -202™ INSTRUMENT 11
4.1 NC-VIEW SOFTWARE ........................................................................................... 11
4.2 PROTOCOL EXECUTION ........................................................................................... 11
4.2.1 Piston movements ...................................................................................... 12
4.3 PROTECTION OF THE OPTICAL SYSTEM ........................................................................ 12
5 MAINTENANCE OF NUCLEOCOUNTER® NC-202™ ....................................................... 13
5.1 CLEANING ........................................................................................................... 13
5.1.1 Instrument cabinet ..................................................................................... 13
5.1.2 Cassette fixture .......................................................................................... 13
5.1.3 Contamination of the optics........................................................................ 13
5.1.4 Decontamination ........................................................................................ 13
6 TROUBLESHOOTING FOR NUCLEOCOUNTER® NC -202™ .............................................. 14
6.1 FIRMWARE AND SOFTWARE VERSION .......................................................................... 14
6.2 POWER-ON FAILURE............................................................................................... 14
Table of Contents
991-2020 Rev. 1.1 November 2019 2
7 TECHNICAL SPECIFICATIONS ..................................................................................... 15
7.1 NUCLEOCOUNTER® NC-202™ ................................................................................. 15
7.2 SAMPLE MEDIA .................................................................................................... 15
7.3 EU STANDARDS .................................................................................................... 15
8 EQUIPMENT AND ACCESSORIES ................................................................................ 17
9 OTHER DOCUMENTATION ........................................................................................ 17
APPENDIX A: WEEE DIRECTIVE INFORMATION IN MORE EU LANGUAGES ........................... 18
10 GENERAL DISCLAIMER .......................................................................................... 21
+ 19 hidden pages