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ChemoMetec NucleoCounter NC-202 Document Compilation

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997-0005
NucleoCounter® NC-202™
Document Compilation
V 1.0
Page 1 of 127

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  • Page 1 997-0005 NucleoCounter® NC-202™ Document Compilation V 1.0 Page 1 of 127...
  • Page 2 992-3101 Package Insert for Via2-Cassettes Statement: ChemoMetec Cassette Conformity Statement Certificate Example: 992-3102 Certificate of Analysis: Via2-Cassette 880-0030-76A QA Measures in the Production of ChemoMetec Cassettes 992-0041 Package Insert - 910-0010 Lysis 1 995-0078 SDS Solution 10 (UK) Certificate Example: Certificate of Product Testing_910-0010_Lysis 1...
  • Page 3 Documents for End-User Validation 994-2022 App Note 2022 NC-202™ IQ/OQ/Zero count protocol 994-2023 Tech Note NC-202™ IQ/OQ (check list) 994-2024 App Note 2024 NC-202™ PQ 994-2025 Tech Note NC-202™ PQ (check list) 994-2026_App Note 2026 Count & Viability – Via2-Cassette™ 994-2028 App Note 2028 Lysis Count –...
  • Page 4 ChemoMetec A/S Statement of Excellence ChemoMetec A/S is committed to developing and improving analytical measurement techniques within the fields of particle counting and liquid chemical composition determination, and to become the supplier and partner of choice for end-users in every application area. In pursuit of this, we are dedicated to the following points: ...
  • Page 5 Doc. No.: 994-2029 v. 1.1 · Issue date: 03-Apr-2020 Page 1 of 6 ChemoMetec A/S · Gydevang 43 · 3450 Allerod · Denmark · support@chemometec.com · www.chemometec.com Page 5 of 127...
  • Page 6 NucleoCounter® NC-202™ and by trypan blue exclusion in manual counting (Figure 2). Doc. No.: 994-2029 v. 1.1 · Issue date: 03-Apr-2020 Page 2 of 6 ChemoMetec A/S · Gydevang 43 · 3450 Allerod · Denmark · support@chemometec.com · www.chemometec.com Page 6 of 127...
  • Page 7 8.2% for manual counting (Figure 3B). Doc. No.: 994-2029 v. 1.1 · Issue date: 03-Apr-2020 Page 3 of 6 ChemoMetec A/S · Gydevang 43 · 3450 Allerod · Denmark · support@chemometec.com · www.chemometec.com Page 7 of 127...
  • Page 8 NC-202™ instruments and (B) manual counting. CV indicates coefficient of variation. Doc. No.: 994-2029 v. 1.1 · Issue date: 03-Apr-2020 Page 4 of 6 ChemoMetec A/S · Gydevang 43 · 3450 Allerod · Denmark · support@chemometec.com · www.chemometec.com Page 8 of 127...
  • Page 9 202™ instruments. One-way ANOVA test shows no significant difference between the three NucleoCounter NC-202™ instruments: P = 0.998. Doc. No.: 994-2029 v. 1.1 · Issue date: 03-Apr-2020 Page 5 of 6 ChemoMetec A/S · Gydevang 43 · 3450 Allerod · Denmark · support@chemometec.com · www.chemometec.com Page 9 of 127...
  • Page 10 Epithelial, adherent YAC-1 Mouse Blood Lymphoblast, suspension *Primary cells Doc. No.: 994-2029 v. 1.1 · Issue date: 03-Apr-2020 Page 6 of 6 ChemoMetec A/S · Gydevang 43 · 3450 Allerod · Denmark · support@chemometec.com · www.chemometec.com Page 10 of 127...
  • Page 11 NucleoCounter® NC-202™. 100 - 2000 n. Doc. No.: 994-2030 v. 1.0 · Issue date: 04-Apr-2020 Page 1 of 3 ChemoMetec A/S · Gydevang 43 · 3450 Allerod · Denmark · support@chemometec.com · www.chemometec.com Page 11 of 127...
  • Page 12 Poisson distribution into consideration. Doc. No.: 994-2030 v. 1.0 · Issue date: 04-Apr-2020 Page 2 of 3 ChemoMetec A/S · Gydevang 43 · 3450 Allerod · Denmark · support@chemometec.com · www.chemometec.com Page 12 of 127...
  • Page 13 Doc. No.: 994-2030 v. 1.0 · Issue date: 04-Apr-2020 Page 3 of 3 ChemoMetec A/S · Gydevang 43 · 3450 Allerod · Denmark · support@chemometec.com · www.chemometec.com Page 13 of 127...
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  • Page 17 In some areas, certain wastes must be tracked. Doc. No. 992-3101 v. 1.1 ∙ Issue date: 26-Apr-2019 Page 1 of 1 Template 880-0011-79C v. 1 ChemoMetec A/S ∙ Gydevang 43 ∙ DK-3450 Allerød ∙ Denmark ∙ support@chemometec.com ∙ www.chemometec.com Page 17 of 127...
  • Page 18 Based on Guidance on requirements for substances in articles (Version 4.0, June 2017) published by the European Chemicals Agency (ECHA) and product descriptions provided by Chemometec* it is assessed that the Cassette with its content of chemical reactants is regarded as an article under Regulation 1907/2006 (REACH-regulation).
  • Page 19 This lot has been tested according to the internal ChemoMetec® quality procedures. The Quality Test is composed of a physical qualification followed by a quantitative test of the cassettes. The results of the quantitative test are presented below.
  • Page 20 880-0030-76A Quality Assurance Measures in the Production of the ChemoMetec Cassettes V 4.0 Contents Document Approval ............................2 Related Documentation .............................2 Revision History ..............................2 Product and Service Inputs: ..........................3 Key Characteristics/Specifications: .........................3 Inspection Points and Monitoring Metrics: ....................3 Entrance Control of Raw Material: ......................3 Production: ..............................3...
  • Page 21 Template for SOP Revision History Revision Date Initials Description 15-Jun-2015 New document 15-Mar-2016 General update 10-May-2016 Layout change 03-Nov-2017 General update 15-Jun-2018 Updated to include all ChemoMetec Cassettes CONFIDENTIAL Template: 880-0017-79A v 4.1 Page 2 of 5 Page 21 of 127...
  • Page 22 ISO9001:2008 Ampliqon A/S Dye Reagent for Cassettes ISO9001:2008 All raw materials received are subjected to entrance control. The Cassettes are assembled, packaged and quality tested at ChemoMetec. Key Characteristics/Specifications: See package insert delivered with the Cassettes. NucleoCassette™ Document number: 992-0003 SP1-Cassette™...
  • Page 23 Doc. No. +Vers. 880-0030-76A v.4 880-0030-76A QA Measures in Production of Date 19-Jun-2018 Owner ChemoMetec Cassettes Approved by Station 2: Cassette Assembly: The dried flow parts are automatically transferred to the assembly line. The flow part and the lid part are welded together.
  • Page 24 Doc. No. +Vers. 880-0030-76A v.4 880-0030-76A QA Measures in Production of Date 19-Jun-2018 Owner ChemoMetec Cassettes Approved by The loaded volume, wetness of the porex and bubbles in the measurement chamber are checked during these hourly tests. Quality Control Test of Finished Cassettes: Seven-nine cassette bags are taken at specific times during the production day.
  • Page 25 Doc. No. +Vers. 880-0030-76A v 3 880-0030-76A QA Measures in Production of Date 19-Jun-2018 ChemoMetec Cassettes Owner Approved by Flow Chart of the Production 1 of 2: Customer demand for cassettes Current inventory status is checked and the prodution Entrance control of raw material...
  • Page 26 Doc. No. +Vers. 880-0030-76A v 3 880-0030-76A QA Measures in Production of Date 19-Jun-2018 ChemoMetec Cassettes Owner Approved by Flow Chart of the Production 2 of 2: Line 2: Assembly The lid part is placed atop the dried flow part and the two...
  • Page 27 Doc.No: 992-0041 v1 · Issue date: 23-Jan-2020 · Released by: ELL Template 880-0011-79C v.1.2 ChemoMetec A/S · Gydevang 43 · 3450 Allerod · Denmark · support@chemometec.com · www.chemometec.com Page 27 of 127...
  • Page 28 (+45) - 48 13 10 21 Denmark e-mail: contact@chemometec.com Responsible person for the safety data sheet (e-mail): contact@chemometec.com 1.4. Emergency telephone number: NHS (England or Wales): Dial 111 or 0845 4647 NHS 24 (Scotland): Dial 111 SECTION 2: Hazards identification 2.1.
  • Page 29 Lysis – Lysis Buffer ChemoMetec A/S Document no. 995-0078 5.1. Extinguishing media: Not flammable. 5.2. Special hazards arising from the substance or mixture: Not relevant (the product is not combustible). 5.3. Advice for firefighters: Do not inhale smoke fumes. When extinguishing surrounding fires use breathing apparatus with an independent source of air.
  • Page 30 Lysis – Lysis Buffer ChemoMetec A/S Document no. 995-0078 SECTION 10: Stability and reactivity 10.1. Reactivity: No available data. 10.2. Chemical stability: Stable under the recommended storage conditions - see section 7. 10.3. Possibility of hazardous reactions: None known. 10.4. Conditions to avoid: Excessive heating.
  • Page 31 Lysis – Lysis Buffer ChemoMetec A/S Document no. 995-0078 SECTION 13: Disposal considerations 13.1. Waste treatment methods: The mixture is to be considered as hazardous waste. Disposal should be according to local, state or national legislation. Dispose of through authority facilities or pass to chemical disposal company.
  • Page 32 Furthermore, Lysis 1 is useful for detaching adherent cell lines and disaggregation of cell clusters. This lot has been tested according to the internal ChemoMetec® quality procedures. The lot meets or exceeds all product specifications. Remarks: None...
  • Page 33 Waste regulations regarding the nature of the mixture it contains. Template 880-0011-79C v.1 ChemoMetec A/S · Gydevang 43 · 3450 Alleroed · Denmark · support@chemometec.com · www.chemometec.com · Page 33 of 127...
  • Page 34 (+45) - 48 13 10 21 Denmark e-mail: contact@chemometec.com Responsible person for the safety data sheet (e-mail): contact@chemometec.com 1.4. Emergency telephone number: NHS (England or Wales): Dial 111 or 0845 4647 NHS 24 (Scotland): Dial 111 SECTION 2: Hazards identification 2.1.
  • Page 35 ChemoMetec® Test Kits ChemoMetec A/S Document no. 995-0072 SECTION 6: Accidental release measures 6.1. Personal precautions, protective equipment and emergency procedures: Use personal protective equipment - see section 8. 6.2. Environmental precautions: Do not empty into drains – see section 12. Inform appropriate authorities in accordance with local regulations.
  • Page 36 ChemoMetec® Test Kits ChemoMetec A/S Document no. 995-0072 SECTION 10: Stability and reactivity 10.1. Reactivity: No available data. 10.2. Chemical stability: Stable under the recommended storage conditions - see section 7. 10.3. Possibility of hazardous reactions: None known. 10.4. Conditions to avoid: Excessive heating and direct sunlight.
  • Page 37 ChemoMetec® Test Kits ChemoMetec A/S Document no. 995-0072 SECTION 13: Disposal considerations 13.1. Waste treatment methods: The mixture is not to be considered as hazardous waste. Disposal should be according to local, state or national legislation. Dispose of through authority facilities or pass to chemical disposal company.
  • Page 38 Installation Qualification (IQ), an Operation Qualification (OQ) and a Zero Count verification. This lot has been tested according to the internal ChemoMetec® quality procedures. The lot meets or exceeds all product specifications. Remarks: None...
  • Page 39 Page 1 of 1 Doc.No: 992-2023 v. 1.0 · Issue date: 05-Dec-2019 Template 880-0011-79C v.1 ChemoMetec A/S · Gydevang 43 · 3450 Allerod · Denmark · support@chemometec.com · www.chemometec.com · Page 39 of 127...
  • Page 40 (+45) - 48 13 10 21 Denmark e-mail: contact@chemometec.com Responsible person for the safety data sheet (e-mail): contact@chemometec.com 1.4. Emergency telephone number: NHS (England or Wales): Dial 111 or 0845 4647 NHS 24 (Scotland): Dial 111 SECTION 2: Hazards identification 2.1.
  • Page 41 ChemoMetec® Test Kits ChemoMetec A/S Document no. 995-0072 SECTION 6: Accidental release measures 6.1. Personal precautions, protective equipment and emergency procedures: Use personal protective equipment - see section 8. 6.2. Environmental precautions: Do not empty into drains – see section 12. Inform appropriate authorities in accordance with local regulations.
  • Page 42 ChemoMetec® Test Kits ChemoMetec A/S Document no. 995-0072 SECTION 10: Stability and reactivity 10.1. Reactivity: No available data. 10.2. Chemical stability: Stable under the recommended storage conditions - see section 7. 10.3. Possibility of hazardous reactions: None known. 10.4. Conditions to avoid: Excessive heating and direct sunlight.
  • Page 43 ChemoMetec® Test Kits ChemoMetec A/S Document no. 995-0072 SECTION 13: Disposal considerations 13.1. Waste treatment methods: The mixture is not to be considered as hazardous waste. Disposal should be according to local, state or national legislation. Dispose of through authority facilities or pass to chemical disposal company.
  • Page 44 Instead, Standard Deviation (SD) is used to evaluate the result. ** = The high Coefficient of Variation is primarely due to Poisson distribution. This lot has been tested according to the internal ChemoMetec quality procedures. The lot meets or exceeds all product specifications.
  • Page 45 Instrument settings test • Zero Count • Doc.No: 994-2022 v. 1.1 · Issue date: 06-SEP-2019 Page 1 of 3 Template 880-0011-79A v.3 ChemoMetec A/S · Gydevang 43 · 3450 Alleroed · Denmark · support@chemometec.com · www.chemometec.com · Page 45 of 127...
  • Page 46 _sn_yyyy-mm-dd_hh.mm.ss.csv), is placed in the verification directory as documentation for the performed IQ/OQ test. Doc.No: 994-2022 v. 1.1 · Issue date: 06-SEP-2019 Page 2 of 3 Template 880-0011-79A v.3 ChemoMetec A/S · Gydevang 43 · 3450 Alleroed · Denmark · support@chemometec.com · www.chemometec.com · Page 46 of 127...
  • Page 47 ChemoMetec A/S. Doc.No: 994-2022 v. 1.1 · Issue date: 06-SEP-2019 Page 3 of 3 Template 880-0011-79A v.3 ChemoMetec A/S · Gydevang 43 · 3450 Alleroed · Denmark · support@chemometec.com · www.chemometec.com · Page 47 of 127...
  • Page 48 OQ successfully executed as indicated by ‘Passed’ in the results message box OK/Yes Fail/No Doc.No: 994-2023 v. 1.0 · Issue Date: 15-MAY-2018 Page 1 of 2 Template 880-0011-79B v. 3.0 ChemoMetec A/S · Gydevang 43 · DK-3450 Allerod · Denmark · support@chemometec.com · www.chemometec.com Page 48 of 127...
  • Page 49 Name: ____________________________ Dept. / Company: _________________________ Doc.No: 994-2023 v. 1.0 · Issue Date: 15-MAY-2018 Page 2 of 2 Template 880-0011-79B v. 3.0 ChemoMetec A/S · Gydevang 43 · DK-3450 Allerod · Denmark · support@chemometec.com · www.chemometec.com Page 49 of 127...
  • Page 50 Doc.No: 994-2024 v. 1.1 · Issue date: 31-Jan-2020 Page 1 of 3 Template 880-0011-79B v.3 ChemoMetec A/S · Gydevang 43 · 3450 Allerod · Denmark · support@chemometec.com · www.chemometec.com · Page 50 of 127...
  • Page 51 Even with stringent procedures for apportioning the bead slurry into the vials, variation in the total bead concentration throughout a production lot is probable. If the total bead count average falls outside the acceptance range, while the CV is below the specified limit, the vial probably represents such variation and ChemoMetec® customer support should be contacted.
  • Page 52 Doc.No: 994-2024 v. 1.1 · Issue date: 31-Jan-2020 Page 3 of 3 Template 880-0011-79B v.3 ChemoMetec A/S · Gydevang 43 · 3450 Allerod · Denmark · support@chemometec.com · www.chemometec.com · Page 52 of 127...
  • Page 53 Zero Count successful as indicated by Passed. OK/Yes Fail/No Doc.No: 994-2025 v. 1.0 · Issue date: 13-Dec-2019 Page 1 of 4 Template 880-0011-79B v.3 ChemoMetec A/S · Gydevang 43 · 3450 Allerod · Denmark · support@chemometec.com · www.chemometec.com · Page 53 of 127...
  • Page 54 Is the CV% on the viability below the accepted maximum value? OK/Yes Fail/No Doc.No: 994-2025 v. 1.0 · Issue date: 13-Dec-2019 Page 2 of 4 Template 880-0011-79B v.3 ChemoMetec A/S · Gydevang 43 · 3450 Allerod · Denmark · support@chemometec.com · www.chemometec.com · Page 54 of 127...
  • Page 55 Is the CV% on the viability below the accepted maximum value? OK/Yes Fail/No Doc.No: 994-2025 v. 1.0 · Issue date: 13-Dec-2019 Page 3 of 4 Template 880-0011-79B v.3 ChemoMetec A/S · Gydevang 43 · 3450 Allerod · Denmark · support@chemometec.com · www.chemometec.com · Page 55 of 127...
  • Page 56 □ □ c) Beads 3 within accepted ranges. OK/Yes Fail/No OBS! If any of the points above are 'Fail/No', please contact ChemoMetec Support. However, make sure the below listed measures have been followed: NC-202 PQ Kit 1. The has NOT been opened/used previously (max 5-7 measurements).
  • Page 57 ChemoMetec A/S All Rights Reserved Page 1 of 3 Doc.No: 994-2026 v. 1.1 · Issue date: 02-Oct-2019 ∙ Template: 880-0011-79A v.3 ChemoMetec A/S · Gydevang 43 · 3450 Alleroed · Denmark · support@chemometec.com · www.chemometec.com · Page 57 of 127...
  • Page 58 ChemoMetec A/S All Rights Reserved Page 2 of 3 Doc.No: 994-2026 v. 1.1 · Issue date: 02-Oct-2019 ∙ Template: 880-0011-79A v.3 ChemoMetec A/S · Gydevang 43 · 3450 Alleroed · Denmark · support@chemometec.com · www.chemometec.com · Page 58 of 127...
  • Page 59 ChemoMetec A/S All Rights Reserved Page 3 of 3 Doc.No: 994-2026 v. 1.1 · Issue date: 02-Oct-2019 ∙ Template: 880-0011-79A v.3 ChemoMetec A/S · Gydevang 43 · 3450 Alleroed · Denmark · support@chemometec.com · www.chemometec.com · Page 59 of 127...
  • Page 60 ChemoMetec A/S All Rights Reserved Page 1 of 4 Doc.No: 994-2028 v. 1.0 · Issue date: 06-Jan-2020 · Template: 880-0011-79A v.3 ChemoMetec A/S · Gydevang 43 · 3450 Alleroed · Denmark · support@chemometec.com · www.chemometec.com · Page 60 of 127...
  • Page 61 ChemoMetec A/S All Rights Reserved Page 2 of 4 Doc.No: 994-2028 v. 1.0 · Issue date: 06-Jan-2020 · Template: 880-0011-79A v.3 ChemoMetec A/S · Gydevang 43 · 3450 Alleroed · Denmark · support@chemometec.com · www.chemometec.com · Page 61 of 127...
  • Page 62 ChemoMetec A/S All Rights Reserved Page 3 of 4 Doc.No: 994-2028 v. 1.0 · Issue date: 06-Jan-2020 · Template: 880-0011-79A v.3 ChemoMetec A/S · Gydevang 43 · 3450 Alleroed · Denmark · support@chemometec.com · www.chemometec.com · Page 62 of 127...
  • Page 63 ChemoMetec A/S All Rights Reserved Page 4 of 4 Doc.No: 994-2028 v. 1.0 · Issue date: 06-Jan-2020 · Template: 880-0011-79A v.3 ChemoMetec A/S · Gydevang 43 · 3450 Alleroed · Denmark · support@chemometec.com · www.chemometec.com · Page 63 of 127...
  • Page 64 NucleoCounter NC-202 ® ™ Instrument User Guide P/N 991-2020 Revision 1.3 March 2020 ChemoMetec A/S Gydevang 43 · DK-3450 Allerød · Denmark Telephone: (+45) 48 13 10 20 Website: www.chemometec.com E-mail: contact@chemometec.com Page 64 of 127...
  • Page 65 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 ensure their accuracy, ChemoMetec assumes no liability resulting from errors or omissions in these documents, or from the use of the information contained herein.
  • Page 66 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 991-2020 Rev. 1.3 March 2020 Page 66 of 127...
  • Page 67 WEEE Directive Information – Europe Only 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.
  • Page 68 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. 991-2020 Rev. 1.3 March 2020 Page 68 of 127...
  • Page 69 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.
  • Page 70 Warnings and Precautions 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.
  • Page 71 Table of Contents Table of Contents DECLARATION OF CONFORMITY ..................III WEEE DIRECTIVE INFORMATION – EUROPE ONLY .............. IV INTRODUCTION AND INTENDED USE ................. V WARNINGS AND PRECAUTIONS ..................VI INSPECTION, UNPACKING AND INSTALLATION OF EQUIPMENT ........3 ® NC-202™ ....3 NSTALLATION AND PERATION UALIFICATION OF...

  • Page 72: Table Of Contents

    Table of Contents TECHNICAL SPECIFICATIONS ..................15 ® NC-202™ ................. 15 UCLEO OUNTER ....................15 AMPLE EDIA EU S ....................15 TANDARDS EQUIPMENT AND ACCESSORIES ................17 OTHER DOCUMENTATION ..................17 APPENDIX A: DESCRIPTION OF CHANGES FROM LATEST REVISION ........18 : .........................
  • Page 73 1 Inspection, Unpacking and Installation of Equipment Upon receiving the order from ChemoMetec, 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 immediately.
  • Page 74 Cell Counting with NucleoCounter® NC-202™ 2 Cell Counting with NucleoCounter® NC-202™ The NucleoCounter® NC-202™ is a dual-color fluorescent cell counting instrument. The NucleoCounter® NC-202™ is simple to operate, requiring little user input to execute e.g. cell counting protocols. The NucleoCounter® NC-202™ is operated by NC-View™ software. The NucleoCounter®...
  • Page 75 Cell Counting with NucleoCounter® NC-202™ New protocols are developed at an on-going basis and an up-to-date list of available protocols can be found at www.chemometec.com 2.1.3 The RUN button and LED indicator On the front of the NucleoCounter® NC-202™ there is a RUN button. Activating this will run the selected type of analysis on the instrument.
  • Page 76 Cell Counting with NucleoCounter® NC-202™ The Via2-Cassette™ Figure 1: The Via2-Cassette™ contains two fluorescent dyes, AO (Acridine Orange) and DAPI (4',6-diamidino-2-phenylindole), deposited in the first part of the flow system 2.2.1 Loading the Via2-Cassette™ cassette The Via2-Cassette™ is loaded by pressing the white piston down while the cassette tip is immersed in the cell sample (Figure 3).
  • Page 77 Cell Counting with NucleoCounter® NC-202™ the instrument to i) move the piston to drive the cell sample through the mixing channels and into the measurement chamber; ii) fixate the cassette in the slot; and iii) record the fluorescence images, analyze data and present the counting result. Once analysis is complete, the sample and dyes are contained inside the cassette, which can be safely discarded.
  • Page 78 3 NucleoCounter® NC-202™ – Instrument Controls 3 NucleoCounter® NC-202™ – Instrument Controls Interactive Controls Figure 3: Front of the NucleoCounter® NC-202™ The NucleoCounter® NC-202™ has two operational areas: • Cassette fixture covered by a yellow lid RUN button and tri-color LED status indicator •...
  • Page 79 3 NucleoCounter® NC-202™ – Instrument Controls NucleoCounter® NC-202™ Connections Rear view of the instrument (Figure 5) features the DC power inlet, fuse holder (Figure 6) and a USB 3.0 socket (Figure 7). The NucleoCounter® NC-202™ is delivered with a region-specific power cable to connect the external power supply to the main power supply.
  • Page 80 USB connection and initialization The NucleoCounter® NC-202™ is connected using a USB 3.0 micro B – A or B – C cable. Only cables provided by ChemoMetec should be used with the instrument. Figure 6: USB 3.0 port Launching the NC-View™ software commences a short initialization sequence, which includes an instrument communication check and positioning of the piston motor.
  • Page 81 4 Operation of NC-View™ Software and NucleoCounter® NC-202™ Instrument 4 Operation of NC-View™ Software and NucleoCounter® NC-202™ Instrument NC-View™ Software The NC-View™ software is used for data acquisition, image analysis and display of results. For further details regarding NC-View™, refer to the NC-View™ Software User Guide (#991- 2022).
  • Page 82 4 Operation of NC-View™ Software and NucleoCounter® NC-202™ Instrument 4.2.1 Piston movements When a cassette is analyzed, the piston motor will move the piston rod down through the cassette cylinder. Hereby, the sample is transported to the cassette’s measurement chamber while sensors monitor the sample flow. When the sample has been loaded into the measurement chamber and reaches the end of the flow channel, the piston is stopped.
  • Page 83 Do not use compressed air from a single use-can, since these contain chemicals that can reduce optical performance. ChemoMetec’s support should be contacted if the contaminant cannot be removed with compressed air.
  • Page 84 Figure 9 (turn counterclockwise). Inspect the fuse. If it needs replacement use one as described by ChemoMetec. If the NucleoCounter® NC-202™ does not turn on after replacing the fuse, or if the fuse was not blown, please contact ChemoMetec or your local distributor for further instructions. 991-2020 Rev. 1.3...

  • Page 85: Technical Specifications

    7 Technical Specifications 7 Technical Specifications NucleoCounter® NC-202™ Optics Lens with ×2.1 magnification, 2/3” CMOS Sample device Via2-Cassettes™ intended for NucleoCounter® NC-202™ Excitation (nm) 2 LED light sources with peak wavelengths at 365 nm and 505 nm Emission (nm) A single dual-band emission filter: 410-460 nm and 540-650 nm Sample consumption Approximately 60 μl Analyzed volume...
  • Page 86 7 Technical Specifications Standards EN 61326-1:2013 Electrical equipment for laboratory use EMC: 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 EN 61010-1:2010 Safety requirements for electrical equipment for LVD: measurement, control, and laboratory use Standards...

  • Page 87: Equipment And Accessories

    An updated list of equipment and accessories for the NucleoCounter® NC-202™ are available from www.chemometec.com. 9 Other Documentation The table below shows a list of documents relevant for NucleoCounter® NC-202™ operations. These documents can be downloaded from www.chemometec.com. Document Document Type Document number...

  • Page 88: Appendix A: Description Of Changes From Latest Revision

    Appendix A: Description of changes from latest revision Appendix A: Description of changes from latest revision This chapter describes changes from latest version of this user guide. New: • N/A Changes: • Updated information on Cassette fixture to section 2.1.4 to describe audible ‘clicks’...

  • Page 89: Appendix B: Weee Directive Information In More Eu Languages

    Appendix B: WEEE Directive Information in More EU Languages Appendix B: WEEE Directive Information in More EU Languages United Correct Disposa l of This Product Kingdom (Waste Electr ical & Elec tronic Equ ipment) - Europe only This ma rking show n on the product or its literature, indicates that it should not be disposed of together with ot her house hol d wastes at t he e nd of its working life.
  • Page 90 Appendix B: WEEE Directive Information in More EU Languages Norway Korrekt avhending av dette produk t (Avfall elektrisk og elektron isk uts tyr) - Kun Europa Denne m erkingen som vises på produktet eller dens dokument asjon, i ndikere r at de n ikke skal kastes sammen med annet hus holdni ngsavfall ved slutten av sin levetid.
  • Page 91 Appendix B: WEEE Directive Information in More EU Languages Finland Tämän tuotteen turvallinen hävittämin en (elek troniikka ja sähk ölaitteet) - Vain Eu rooppa Oheinen me rkintä tuotteessa tai tuotteen oheismate riaalissa merkitsee, että tätä t uotetta ei tule hävittää kotitalousjättee n mukana sen elinkaa ren päätyttyä.

  • Page 92: 11 General Disclaimer

     NC-202™ or Via2-Cassette™ shall be construed to imply any warranty or guarantee. ChemoMetec and affiliated companies shall not be held liable for damages and customers shall indemnify ChemoMetec and affiliated companies against liability resulting from use of potentially inaccurate data generated by the NucleoCounter .
  • Page 93 NC-View™ Software User Guide P/N 991-2022 Revision 1.3 January 2020 ChemoMetec A/S Gydevang 43 · DK-3450 Allerod · Denmark Telephone: (+45) 48 13 10 20 www.chemometec.com Website: E-mail: cont ct@chemometec.com Page 93 of 127...
  • Page 94 Copyright Notices Copyright © ChemoMetec A/S 2019. All rights reserved. No part of this publication or 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 ChemoMetec A/S, Gydevang 43, DK-3450 Allerod, Denmark.
  • Page 95 TROUBLESHOOTING ..............................19 ..............................21 REATING UPPORT ILES Doc. No: 991-2022 v. 1.3 · Issue date: 24-January-2020 · ChemoMetec A/S · Gydevang 43 · DK-3450 Allerod · Denmark · Email: contact@chemometec.com · Web: www.chemometec.com FORM 880-0011-79 v.2 Page 95 of 127...

  • Page 96: Quick Guide

    Repeat steps 4, 5 and 6 to perform the same protocol on a new sample. Doc. No: 991-2022 v. 1.3 · Issue date: 24-January-2020 · ChemoMetec A/S · Gydevang 43 · DK-3450 Allerod · Denmark · Email: contact@chemometec.com · Web: www.chemometec.com FORM 880-0011-79 v.2...

  • Page 97: Getting Started

    For more details see the Installation Guide section below. Doc. No: 991-2022 v. 1.3 · Issue date: 24-January-2020 · ChemoMetec A/S · Gydevang 43 · DK-3450 Allerod · Denmark · Email: contact@chemometec.com · Web: www.chemometec.com FORM 880-0011-79 v.2 Page 97 of 127...

  • Page 98: Startup

    Browser: Shows the acquired data files (CM files) and is used to open files in the image display, export data or administrate data files Doc. No: 991-2022 v. 1.3 · Issue date: 24-January-2020 · ChemoMetec A/S · Gydevang 43 · DK-3450 Allerod · Denmark · Email: contact@chemometec.com · Web: www.chemometec.com FORM 880-0011-79 v.2 Page 98 of 127...

  • Page 99: Nc-View™ Basic Concepts And Terminology

    NC-View™ Basic Concepts and Terminology • CM file: A ChemoMetec proprietary file format that contains the images, the result data and the metadata with file information. The file type is displayed as .cm • Protocol: A file containing the settings on how the instrument acquires images, performs the image analysis and presents the results •...

  • Page 100: Using Nc-View

    ChemoMetec and no subsequent calibration is required. Doc. No: 991-2022 v. 1.3 · Issue date: 24-January-2020 · ChemoMetec A/S · Gydevang 43 · DK-3450 Allerod · Denmark · Email: contact@chemometec.com · Web: www.chemometec.com FORM 880-0011-79 v.2 Page 100 of 127...

  • Page 101: Sample And Dilution Volumes

    If the user changes the volume in the solution input field, this volume will not be automatically updated anymore Doc. No: 991-2022 v. 1.3 · Issue date: 24-January-2020 · ChemoMetec A/S · Gydevang 43 · DK-3450 Allerod · Denmark · Email: contact@chemometec.com · Web: www.chemometec.com FORM 880-0011-79 v.2 Page 101 of 127...

  • Page 102: Operating The Image Panel

    Utilize this function for visual inspection of the counted cells Doc. No: 991-2022 v. 1.3 · Issue date: 24-January-2020 · ChemoMetec A/S · Gydevang 43 · DK-3450 Allerod · Denmark · Email: contact@chemometec.com · Web: www.chemometec.com FORM 880-0011-79 v.2 Page 102 of 127...

  • Page 103: Visual Inspection Of Counted Cells

    Dead overlay checkboxes to enable the display of both overlays. Doc. No: 991-2022 v. 1.3 · Issue date: 24-January-2020 · ChemoMetec A/S · Gydevang 43 · DK-3450 Allerod · Denmark · Email: contact@chemometec.com · Web: www.chemometec.com FORM 880-0011-79 v.2...

  • Page 104: File List In Main Window

    NOTE: Not all result columns will be available for all CM file types Doc. No: 991-2022 v. 1.3 · Issue date: 24-January-2020 · ChemoMetec A/S · Gydevang 43 · DK-3450 Allerod · Denmark · Email: contact@chemometec.com · Web: www.chemometec.com FORM 880-0011-79 v.2...

  • Page 105: Define Columns To Display

    NOTE: File Name cannot be deselected Doc. No: 991-2022 v. 1.3 · Issue date: 24-January-2020 · ChemoMetec A/S · Gydevang 43 · DK-3450 Allerod · Denmark · Email: contact@chemometec.com · Web: www.chemometec.com FORM 880-0011-79 v.2 Page 105 of 127...

  • Page 106: Selecting A Protocol

    All Users or a single user can be selected as a search tool for locating the protocol of interest Doc. No: 991-2022 v. 1.3 · Issue date: 24-January-2020 · ChemoMetec A/S · Gydevang 43 · DK-3450 Allerod · Denmark · Email: contact@chemometec.com · Web: www.chemometec.com FORM 880-0011-79 v.2 Page 106 of 127...

  • Page 107: Open Previously Acquired Data Files

    Properties: File properties of a selected CM file open in a new window Doc. No: 991-2022 v. 1.3 · Issue date: 24-January-2020 · ChemoMetec A/S · Gydevang 43 · DK-3450 Allerod · Denmark · Email: contact@chemometec.com · Web: www.chemometec.com FORM 880-0011-79 v.2...

  • Page 108: Export Result Data

    3. Paste the data into a spreadsheet Doc. No: 991-2022 v. 1.3 · Issue date: 24-January-2020 · ChemoMetec A/S · Gydevang 43 · DK-3450 Allerod · Denmark · Email: contact@chemometec.com · Web: www.chemometec.com FORM 880-0011-79 v.2 Page 108 of 127...

  • Page 109: Export Pdf Reports

    5. Select the print options (Result Table, Images, Signatures) and click Ok to save the PDF report(s) Doc. No: 991-2022 v. 1.3 · Issue date: 24-January-2020 · ChemoMetec A/S · Gydevang 43 · DK-3450 Allerod · Denmark · Email: contact@chemometec.com · Web: www.chemometec.com FORM 880-0011-79 v.2...

  • Page 110: Software Options

    NOTE: If the requirements are not met, the setup will not block installation nor provide any warnings Doc. No: 991-2022 v. 1.3 · Issue date: 24-January-2020 · ChemoMetec A/S · Gydevang 43 · DK-3450 Allerod · Denmark · Email: contact@chemometec.com · Web: www.chemometec.com FORM 880-0011-79 v.2...

  • Page 111: Installing And Upgrading

    CM files if they are exported or copied to show that the data integrity may have been compromised. Doc. No: 991-2022 v. 1.3 · Issue date: 24-January-2020 · ChemoMetec A/S · Gydevang 43 · DK-3450 Allerod · Denmark · Email: contact@chemometec.com · Web: www.chemometec.com FORM 880-0011-79 v.2...

  • Page 112: Troubleshooting

    Doc. No: 991-2022 v. 1.3 · Issue date: 24-January-2020 · ChemoMetec A/S · Gydevang 43 · DK-3450 Allerod · Denmark · Email: contact@chemometec.com · Web: www.chemometec.com FORM 880-0011-79 v.2 Page 112 of 127...
  • Page 113 Reconnect the power or replace the fuse. Doc. No: 991-2022 v. 1.3 · Issue date: 24-January-2020 · ChemoMetec A/S · Gydevang 43 · DK-3450 Allerod · Denmark · Email: contact@chemometec.com · Web: www.chemometec.com FORM 880-0011-79 v.2 Page 113 of 127...

  • Page 114: Creating Support Files

    Support. Using this functionality will create two files: SupportFiles.zip and CrashDumpFiles.zip. These files should be referred to when communicating with ChemoMetec Support. Be aware that the size of the CrashDumpFiles.zip file can be very large. ChemoMetec Support can assist with transferring files that are too large to send by e-mail.
  • Page 115 Terms and Acronyms ............................8 Product Notes ..............................9 Page 1 of 9 Doc.No: 991-2021 v. 1.0 · Issue date: 01-Jul-2019 Chemometec A/S · Gydevang 43 · 3450 Allerod · Denmark · support@chemometec.com · www.chemometec.com · Page 115 of 127...

  • Page 116: Introduction

    21 CFR Part 11 compatible. Page 2 of 9 Doc.No: 991-2021 v. 1.0 · Issue date: 01-Jul-2019 Chemometec A/S · Gydevang 43 · 3450 Allerod · Denmark · support@chemometec.com · www.chemometec.com · Page 116 of 127...

  • Page 117: Setting Up Nc-View

    Activation will be registered in the Audit trail. Page 3 of 9 Doc.No: 991-2021 v. 1.0 · Issue date: 01-Jul-2019 Chemometec A/S · Gydevang 43 · 3450 Allerod · Denmark · support@chemometec.com · www.chemometec.com · Page 117 of 127...

  • Page 118: User Level Restrictions

    Table 1. User restrictions in NC-View™ Secure Mode and at different users group levels. Page 4 of 9 Doc.No: 991-2021 v. 1.0 · Issue date: 01-Jul-2019 Chemometec A/S · Gydevang 43 · 3450 Allerod · Denmark · support@chemometec.com · www.chemometec.com · Page 118 of 127...

  • Page 119: File Types And Data Storage Locations

    Image files produced by NC-View™ hold all primary analysis data (sample ID, Fluorescent Images, Counting data matrix, acquisition setting, instrument ID, user ID and other meta data). These files use a ChemoMetec® proprietary file format with the .cm-extension and are named based on date and data recording sequence.

  • Page 120: Integrity Of Local Files

    Windows to block writing access to the following folder structure: C:\Users\Public\Documents\ChemoMetec\NC-View Page 6 of 9 Doc.No: 991-2021 v. 1.0 · Issue date: 01-Jul-2019 Chemometec A/S · Gydevang 43 · 3450 Allerod · Denmark · support@chemometec.com · www.chemometec.com · Page 120 of 127...
  • Page 121 .cm-files if they are exported or copied out of the secure folder to show that the data integrity may have been compromised. Page 7 of 9 Doc.No: 991-2021 v. 1.0 · Issue date: 01-Jul-2019 Chemometec A/S · Gydevang 43 · 3450 Allerod · Denmark · support@chemometec.com · www.chemometec.com · Page 121 of 127...

  • Page 122: Terms And Acronyms

    Page 8 of 9 Doc.No: 991-2021 v. 1.0 · Issue date: 01-Jul-2019 Chemometec A/S · Gydevang 43 · 3450 Allerod · Denmark · support@chemometec.com · www.chemometec.com · Page 122 of 127...

  • Page 123: Product Notes

    ChemoMetec A/S reserves the right to make changes in the product without reservation and without notification to its users. ChemoMetec A/S assumes no liability regarding the cited text from the 21 CFR Part 11 regulative and always directs the reader to FDA for correct and full information regarding all the 21 CFR Part 11 regulations.
  • Page 124 E-notation ChemoMetec A/S All Rights Reserved Page 1 of 4 Doc.No: 994-2031 v. 1.0 · Issue date: 16-Mar-2020 · Template: 880-0011-79B v.4 ChemoMetec A/S · Gydevang 43 · 3450 Allerod · Denmark · support@chemometec.com · www.chemometec.com Page 124 of 127...
  • Page 125 If no cells are found the output is a string "NA" ChemoMetec A/S All Rights Reserved Page 2 of 4 Doc.No: 994-2031 v. 1.0 · Issue date: 16-Mar-2020 · Template: 880-0011-79B v.4 ChemoMetec A/S · Gydevang 43 · 3450 Allerod · Denmark · support@chemometec.com · www.chemometec.com Page 125 of 127...
  • Page 126 ";" ChemoMetec A/S All Rights Reserved Page 3 of 4 Doc.No: 994-2031 v. 1.0 · Issue date: 16-Mar-2020 · Template: 880-0011-79B v.4 ChemoMetec A/S · Gydevang 43 · 3450 Allerod · Denmark · support@chemometec.com · www.chemometec.com Page 126 of 127...
  • Page 127 A/S, Gydevang 43, DK-3450 Allerod, Denmark. ChemoMetec A/S All Rights Reserved Page 4 of 4 Doc.No: 994-2031 v. 1.0 · Issue date: 16-Mar-2020 · Template: 880-0011-79B v.4 ChemoMetec A/S · Gydevang 43 · 3450 Allerod · Denmark · support@chemometec.com · www.chemometec.com Page 127 of 127...

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