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1 | C13232AA7 Part1 | Users Manual | 4.51 MiB | November 07 2018 / July 01 2019 |
Instruction For Use Vi-CELL BLU Cell Viability Analyzer Vi-CELL BLU FINAL Subject_to_Technical_Review PN C13232AA7 FINAL June 2018 Beckman Coulter, Inc. 250 S. Kraemer Blvd. Brea, CA 92821 U.S.A. Draft Labeling Subject to Technical Review Vi-CELL BLU Cell Viability Analyzer Instructions for Use PN C13232AA5 (April 2018) 2018 Beckman Coulter, Inc. All Rights Reserved Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries. Contact Us If you have any questions, contact our Customer Support Center. Worldwide, find us via our website at www.beckmancoulter.com/customersupport/support. In the USA and Canada, call us at 1-800-369-0333. Outside of the USA and Canada, contact your local Beckman Coulter Representative. Beckman Coulter Eurocenter S.A. 22, rue Juste-Olivier Case Postale 1044 CH - 1260 Nyon 1, Switzerland Tel: +41 (0) 22 365 36 11 Draft Labeling Subject to Technical Review Revision History Initial Issue, 05/18 Software version 1.0 This document applies to the latest software listed and higher versions. When a subsequent software version affects the information in this document, a new issue will be released to the Beckman Coulter Web site. For labeling updates, go to www.beckmancoulter.com and download the latest version of the manual or system help for your instrument. PN C13232AA7 FINAL iii Draft Labeling Subject to Technical Review Revision History iv PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Safety Notice Read all product manuals and consult with Beckman Coulter-trained personnel before attempting to operate instrument. Do not attempt to perform any procedure before carefully reading all instructions. Always follow product labeling and manufacturers recommendations. If in doubt as to how to proceed in any situation, contact us. Beckman Coulter, Inc. urges its customers to comply with all national health and safety standards such as the use of barrier protection. This may include, but is not limited to, protective eyewear, gloves, and suitable laboratory attire when operating or maintaining this or any other automated laboratory analyzer. Alerts for Warning and Caution Throughout this manual, you will see the appearance of these alerts for Warning and Caution conditions:
WARNING WARNING indicates a potentially hazardous situation, which, if not avoided, could result in death or serious injury. In this document the signal word WARNING is only used to indicate the possibility of personal injury. It is not used to indicate the possibility of erroneous data. CAUTION CAUTION indicates a potentially hazardous situation, which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices. PN C13232AA7 FINAL v Draft Labeling Subject to Technical Review Safety Notice Safety Precautions Safety Precautions WARNING Risk of operator injury if:
All doors covers and panels are not closed and secured in place prior to and during instrument operation. Instrument alarms and error messages are not acknowledged and acted upon. You mishandle broken parts. Doors, covers and panels are not opened, closed, removed and/or replaced with care. Improper tools are used for troubleshooting. To avoid injury:
Keep doors, covers and panels closed and secured in place while the instrument is in use. Take full advantage of the safety features of the instrument. Acknowledge and act upon instrument alarms and error messages. Keep away from moving parts. Report any broken parts to your Beckman Coulter Representative. Open/remove and close/replace doors, covers and panels with care. Use the proper tools when troubleshooting. CAUTION System integrity could be compromised and operational failures could occur if:
This equipment is used in a manner other than specified. Operate the instrument as instructed in the Product Manuals. You introduce software that is not authorized by Beckman Coulter into your computer. Only operate your systems computer with software authorized by Beckman Coulter. You install software that is not an original copyrighted version. Only use software that is an original copyrighted version to prevent virus contamination. You connect external devices such as thumb drives and external hard drives. Ensure that all external devices are free from viruses before connecting. CAUTION If you purchased this product from anyone other than Beckman Coulter or an authorized Beckman Coulter distributor, and, it is not presently under a Beckman Coulter service maintenance agreement, Beckman Coulter cannot guarantee that the product is fitted with the most current mandatory engineering revisions or vi PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Safety Notice General Warning and Cautions that you will receive the most current information bulletins concerning the product. If you purchased this product from a third party and would like further information concerning this topic, call your Beckman Coulter Representative. WARNING California Proposition 65: This product can expose you to chemicals including phthalates, which are known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov. General Warning and Cautions WARNING Risk of infection. Dispose and handle all solid waste and Reagent Packs as biohazardous waste. Follow your local regulations. Always use the appropriate Personal Protective Equipment (PPE) when working with biohazardous materials. If unsure, ask your Laboratory Safety Officer. Use universal precautions when working with pathogenic materials. Means must be available to decontaminate the instrument and to dispose of biohazardous waste. WARNING Risk of operator injury or biohazardous contamination if you have skin contact with the sample probe or reagent probe. The sample probe or reagent probe might contain residual biological material and must be handled with care. Clean up spills immediately. Use universal precautions when working with pathogenic materials. Means must be available to decontaminate the instrument and to dispose of biohazardous waste. Always use the appropriate Personal Protective Equipment (PPE) when working with biohazardous materials. PN C13232AA7 FINAL vii Draft Labeling Subject to Technical Review Safety Notice Electrical Safety WARNING Risk of infection. Only let authorized personnel collect and work with biologic samples. Make sure to wear gloves. Use universal precautions when working with pathogenic materials. Means must be available to decontaminate the instrument and to dispose of biohazardous waste. WARNING Risk of infection. Make sure that you wear gloves during replacement and maintenance procedures. Use universal precautions when working with pathogenic materials. Means must be available to decontaminate the instrument and to dispose of biohazardous waste. CAUTION Risk of operator injury. The reagent door and the sample station contain automated moving parts. Use caution around these areas to avoid injury. CAUTION Risk of instrument damage. If conditions cause static charge to exist in your lab, be sure to properly ground yourself before touching the instrument. Electrical Safety To prevent electrically related injuries and property damage, properly inspect all electrical equipment prior to use and immediately report any electrical deficiencies. Contact us for any servicing of equipment requiring the removal of covers or panels. CAUTION Risk of electric shock. The external power supply module uses a three-wire power cord and plug to connect it to earth-ground. Make sure that the matching wall outlet receptacle is properly wired and earth-grounded. Never cut-off the plug's ground pin or use a three prong to two prong adapter. viii PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Safety Notice EMC CAUTION Risk of equipment damage. This instrument uses an external, certified, power supply module. Do not substitute with another power supply module. If you experience problems, immediately unplug the power supply module from the wall outlet and call a Beckman Coulter representative for assistance. CAUTION Risk of instrument damage. The power-supply cord and plug of the analyzer must comply with national regulations. External devices connected to the analyzer must be in compliance with the standard UL 60950 for US and IEC 60950 for Europe. If the regulations are not complied with, the equipment may be damaged. EMC CAUTION It is advised that prior to operation of the device, the electromagnetic environment should be evaluated. Do not use this device in close proximity to sources of strong electromagnetic radiation (for example, unshielded intentional RF sources), as these could interfere with the proper operation. CAUTION Changes or modifications not expressly approved could void your authority to use this equipment. Certification Canadian Radio Interference-Causing Equipment Regulation, IECS-003, Class A:
Supporting test records reside with the manufacturer. This Class A digital apparatus meets all requirements of the Canadian Interference-Causing Equipment Regulations. Cet appareil numrique de classe A rpond toutes les exigences de la rglementation canadienne sur les quipements provoquant des interfrences. FCC Part 15, Class "A" Limits Supporting test records reside with the manufacturer. The device complies with Part 15 of the FCC Rules. Operation is subject to the following conditions:
1. The equipment may not cause harmful interference. PN C13232AA7 FINAL ix Draft Labeling Subject to Technical Review Safety Notice Certification 2. The equipment must accept any interference received, including interference that may cause undesired operation. Changes or modifications to this equipment not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to Part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference, in which case the user will be required to correct the interference at their expense. The following techniques can be used to reduce interference problems:
1. Disconnect the equipment from its power source to verify that it is or is not the source of the interference. If the equipment is connected to the same outlet as the device experiencing interference, connect the equipment to a different outlet. 2. 3. Move the equipment away from the device receiving the interference. 4. Reposition the receiving antenna for the device receiving the interference. 5. Try combinations of the above. RFID Module This instrument contains an internal radio frequency identification device (RFID) certified for the countries in which it will be marketed. Certification IDs are listed on the exterior label of the instrument. Refer to for RFID specifications. Registration Information Parameter FCC identification number Canadian ISED identification number KCC certification number Japan certification number Frequency RF output power Value FCC ID: 2AOSQRFIDM2 IC: 23864-RFIDM2 R-CMM-bci-RFIDM2 TBD 13.56 MHz to 7 kHz
<200 mW x PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Safety Notice Disposal of Electronic Equipment Disposal of Electronic Equipment It is important to understand and follow all laws regarding the safe and proper disposal of electrical instrumentation. The symbol of a crossed-out wheeled bin on the product is required in accordance with the Waste Electrical and Electronic Equipment (WEEE) Directive of the European Union. The presence of this marking on the product indicates:
That the device was put on the European Market after August 13, 2005 and That the device is not to be disposed via the municipal waste collection system of any member state of the European Union. For products under the requirement of WEEE directive, please contact your dealer or local Beckman Coulter office for the proper decontamination information and take back program which will facilitate the proper collection, treatment, recovery, recycling, and safe disposal of device. PN C13232AA7 FINAL xi Draft Labeling Subject to Technical Review Safety Notice Moving Parts Moving Parts WARNING Risk of personal injury. To avoid injury due to moving parts, observe the following:
Never attempt to exchange labware, reagents, or tools while the instrument is operating. Never attempt to physically restrict any of the moving components of the instrument. Do not override instrument interlocks Keep the instrument work area clear to prevent obstruction of the movement. Vi-CELL BLU Vi-CELL BLU 3234082AA Cleaning WARNING Risk of infection. Make sure that you wear gloves during replacement and maintenance procedures. Use universal precautions when working with pathogenic materials. Means must be available to decontaminate the instrument and to dispose of biohazardous waste. Always use the appropriate Personal Protective Equipment (PPE) when working with biohazardous materials. If unsure, check with your Laboratory Safety Officer or Lab Supervisor. Observe the cleaning procedures outlined in this manual for the instrument. Prior to cleaning equipment that has been exposed to hazardous material:
Contact the appropriate Chemical and Biological Safety personnel. xii PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Safety Notice Maintenance Review the Chemical and Biological Safety information in the this manual. Maintenance Perform only the maintenance described in this manual. Maintenance other than that specified in this manual should be performed only by service engineers. IMPORTANT It is your responsibility to decontaminate components of the instrument before requesting service by a Beckman Coulter Representative or returning parts to Beckman Coulter for repair. Beckman Coulter will NOT accept any items which have not been decontaminated where it is appropriate to do so. If any parts are returned, they must be enclosed in a sealed plastic bag stating that the contents are safe to handle and are not contaminated. RoHS Notice These labels and materials declaration table (the Table of Hazardous Substance's Name and Concentration) are to meet Peoples Republic of China Electronic Industry Standard SJ/T11364-2006 Marking for Control of Pollution Caused by Electronic Information Products requirements. RoHS Caution Label This label indicates that the electronic information product contains certain toxic or hazardous substances. The center number is the Environmentally Friendly Use Period (EFUP) date, and indicates the number of calendar years the product can be in operation. Upon the expiration of the EFUP, the product must be immediately recycled. The circling arrows indicate the product is recyclable. The date code on the label or product indicates the date of manufacture. PN C13232AA7 FINAL xiii Draft Labeling Subject to Technical Review Safety Notice Safety Symbols Safety Symbols Safety symbols alert you to potentially dangerous conditions. The symbol applies to specific procedures and appears as needed throughout this manual. Symbol Warning Condition Biohazard Consider all materials (specimens, controls, monoclonal antibodies, and so forth) as being potentially infectious. NOTE This symbol does not appear on the instrument. This symbol is used in instrument documentation Caution / Warning Pierce hazard The instrument contains probes and moving parts. The probes are sharp and the probe motor is strong enough to cause the probe to puncture your skin. The probe may contain biohazardous materials, including controls, monoclonal antibodies, and blood samples. The probe is in motion during many types of instrument cycles such as startup and shutdown, not just during sample analysis. A CE mark indicates that a product has been assessed before being placed on the market, and has been found to meet European Union safety, health, and/or environmental protection requirements. Action Use universal precautions when working with pathogenic materials. Means must be available to decontaminate the instrument and to dispose of biohazardous waste. Wear standard laboratory attire and follow safe laboratory procedures when handling any material in the laboratory. Refer to the appropriate section in this manual for more information. Avoid any unnecessary contact with the probe and probe area. Always use caution when working in the probe area. None xiv PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Contents CHAPTER 1:
CHAPTER 2:
Revision History, iii Safety Notice, v Introduction, xxi Introducing the Vi-CELL BLU, 1-1 System Overview, 1-1 Sequence of Analysis Events, 1-1 Vi_CELL BLU Normal Mode, 1-1 Vi_CELL BLU Fast Mode, 1-2 Measuring Viability And Cellular Parameters, 1-3 Why Measure Viability?, 1-3 Historical Perspective The Hemacytometer, 1-3 How Viability is Determined, 1-3 The Trypan Blue Dye Exclusion Method, 1-3 An Image Analysis Solution, 1-3 System Components, 1-5 Software, 1-6 Installation and Verification, 2-1 Special Requirements Pre-installation Checks, 2-1 Environment, 2-1 Power Requirements, 2-1 Temperature and Humidity Requirements, 2-2 Worktable, 2-2 Ventilation and Cleaning, 2-3 Installation, 2-4 Materials Shipped, 2-4 Unpacking, 2-5 Connecting the Instrument, 2-6 First time Login, 2-8 Home Screen, 2-9 Install a Reagent Pack, 2-11 System Settings, 2-16 Setup Users, 2-19 User Administration, 2-19 xv Draft Labeling Subject to Technical Review Contents CHAPTER 3:
CHAPTER 4:
CHAPTER 5:
CHAPTER 6:
Add a User, 2-19 Edit a User, 2-20 My Profile, 2-21 Instrument Status, 2-22 Instrument Performance Verification, 2-22 Daily Verification, 2-22 Startup, 3-1 Daily Startup, 3-1 Setting Up Preferences, 3-3 Run Samples, 4-1 Add Carousel Samples to the Queue, 4-1 Add 96 Well Plate Samples to the Queue, 4-4 Run Results, 4-8 Camera Image Options, 4-9 Bioprocess Results, 4-12 What Is A Bioprocess?, 4-12 Signoff Results, 4-14 Data Analysis, 5-1 Reviewing/Reanalyze Data, 5-1 Import Results, 5-2 Export Results, 5-4 Software Administration, 6-1 Cell Type Administration, 6-1 What is a Cell Type?, 6-1 Cell Type Screen, 6-1 Reports Administration, 6-4 Report Results, 6-4 Completed Run Summary Reports, 6-4 Run Results Reports, 6-5 Bioprocess Reports, 6-7 Quality controls Reports, 6-8 Cell type Reports, 6-10 Instrument Reports, 6-11 Storage Administration, 6-11 User Types and Access Levels, 6-12 xvi Draft Labeling Subject to Technical Review CHAPTER 7:
CHAPTER 8:
APPENDIX A:
APPENDIX B:
APPENDIX C:
APPENDIX D:
APPENDIX E:
Contents Quality Control, 7-1 What Is The Control Feature?, 7-1 Run a Concentration Control, 7-1 Regulatory Compliance 21 CFR Part 11, 8-1 21 CFR Part 11 , 8-1 Electronic Records, 8-1 FDA Requirements, 8-2 Implementing Electronic Records and Signatures, 8-2 Controls for Electronic Records, 8-2 Establishing an Electronic Record, 8-3 21 CFR Part 11 Security, 8-3 File History, 8-3 Electronic Signature, 8-4 Generating Electronic Signatures, 8-5 Applying Electronic Signatures, 8-5 System Specifications, A-1 Data Acquisition, A-1 Cell Viability/Concentration/Cell Count, A-1 Physical Requirements, A-1 Unit Dimensions, A-2 Service and Maintenance, B-1 Focusing Wizard, B-1 Set Focus, B-1 Calibration Control, B-2 Statistics, C-1 Circularity, C-1 System Performance, C-1 Run Statistics, C-1 Effective Field of View, C-1 Troubleshooting, D-1 Troubleshooting Table, D-1 Replacing Reagents and Decontamination, E-1 Reagent Status, E-1 Replace Reagent Pack, E-1 xvii Draft Labeling Subject to Technical Review Contents Prime the Instrument, E-9 Decontaminate, E-9 Decontaminate with Vaporized Hydrogen Peroxide, E-11 Abbreviations Index Beckman Coulter, Inc. Customer End User License Agreement Related Documents xviii Draft Labeling Subject to Technical Review Illustrations Illustrations 1.1 1.2 1.3 2.1 2.2 Trypan Blue Dye Exclusion Method, 1-4 Vi-CELL BLU with carousel, 1-5 Vi-CELL BLU with 96 well plate, 1-6 Home screen, 2-9 Main menu, 2-10 xix Draft Labeling Subject to Technical Review Tables Tables 5 2.1 6.1 D.1 D.2 D.3 D.4 D.5 D.6 Registration Information, -x Main menu buttons, 2-10 User Types and Access Levels, 6-12 Troubleshooting Table - Instrument, D-1 Troubleshooting Table - Controller Board (Main Board), D-3 Troubleshooting Table - Reagents, D-3 Troubleshooting Table - Motion, D-5 Troubleshooting Table - Fluidics, D-6 Troubleshooting Table - Imaging, D-7 xx Draft Labeling Subject to Technical Review Introduction Manual Description This manual is intended to provide the user with information needed to operate and maintain the Vi-CELL BLU system safely and effectively. Conventions This manual applies the following conventions:
Menu and dialog items that can be selected or clicked appear in bold type. Blue text indicates that you can click on the text to access related information. Instrument may be used when referring to the Vi-CELL BLU system. The terms screen and window are used interchangeably. Italics font indicates screen text displayed on the instrument, such as Preparing Samples. The term select is used to indicate either one or both of the following actions:
To tap or touch with your finger. To click with a mouse. The software path to a specific function or screen appears with the greater than ( > ) symbol between the succeeding screen options, like this: File > Open Protocol. NOTE A Note is used to call attention to notable information that should be followed during installation, use or maintenance of this equipment. PN C13232AA7 FINAL xxi Draft Labeling Subject to Technical Review Introduction Safety Safety IMPORTANT An IMPORTANT is used for comments that add value to the step or procedure being performed. Following the advice in the IMPORTANT adds benefit to the performance of a piece of equipment or to a process. See also Safety Notice in the Safety chapter. Hazardous Waste Precautions Always observe local and state regulations regarding the handling and discarding of hazardous waste. Refer to the Material Safety Data Sheet for more information. Vi-CELL BLU Vi-CELL BLU 3234084AA If a hazardous substance such as blood or biological sample is spilled, clean up the spill by using your laboratory decontamination procedure. Then follow your laboratory procedure for disposal of hazardous materials. Reagent Specific Precautions Observe warnings on the packaging of Reagents (Vi-CELL BLU Reagent Pack) and other materials as well as Material Safety Data Sheets. xxii PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Introduction Other Precautions Other Precautions Warnings WARNING If the equipment is used in a manner not specified by Beckman Coulter, Inc., the protection provided by the equipment may be impaired. NOTE For Safety Data Sheets (SDS/MSDS) information, go to the Beckman Coulter website at www.beckmancoulter.com. WARNING Risk of biohazard contamination. Toxicity, safety, and proper handling procedures for diluents and reagents used should be adhered to at all times. To prevent biohazard contamination consult appropriate safety manuals, Safety Data Sheets and Material Safety Data Sheets for the items. Vi-CELL BLU Vi-CELL BLU 3234084AA PN C13232AA7 FINAL xxiii Draft Labeling Subject to Technical Review Introduction Other Precautions xxiv PN C13232AA7 FINAL Draft Labeling Subject to Technical Review CHAPTER 1 Introducing the Vi-CELL BLU System Overview This manual is intended to provide the user with information needed to operate and maintain the Vi-CELL BLU system safely and effectively. The Vi-CELL BLU Cell Viability Analyzer is a video imaging system for analyzing yeast, insect and mammalian cells in culture media or in suspension. It automates the widely accepted trypan blue dye exclusion protocol and is designed to analyze a wide variety of cell types. The software includes features to monitor bioreactors and other cell culture processes and is designed to facilitate compliance with the US Food and Drug Administrations (FDA) regulations on electronic records and electronic signatures (21 CFR Part 11). The main features of the system are:
Fully automated sample preparation, analysis and post run cleaning Cell Viability reported in percentage, concentration and cell count Concentration range of 50,000 to 15,000,000 cells per mL Cell size range of 2 microns to 60 microns 24-position carousel auto-sampler 96 well plate auto-sampler User-friendly reagent system Sequence of Analysis Events IMPORTANT The Vi-CELL BLU performs an auto flush every 24 hour period at 6:00AM. If the unit is turned off during its scheduled flush, it will perform a flush upon the next turn on. For best results, Vi-CELL Blue Normal Mode requires an accurately measured initial sample volume of 0.2 mL +/- 0.02 mL. Vi_CELL BLU Normal Mode The time to complete one cycle in the Vi-CELL BLU Normal Mode is approximately 2:15 minutes. Lena says this needs to be verified, she timed it at 2 min The time to complete is subject to change based upon number of images taken and analysis time. The carousel rotates or sample plate and places the sample under the sample probe. The sample probe lowers into the sample. The syringe aspirates the full volume of 0.6 mL. The syringe dispenses the sample back into the well or vial to re-suspend all cells. PN C13232AA7 FINAL 1-1 Draft Labeling Subject to Technical Review Introducing the Vi-CELL BLU Sequence of Analysis Events The syringe aspirates the complete sample of 0.6 mL. The syringe dispenses all but 0.15 mL (Vi-CELL BLU) of the sample to waste. The syringe draws in 0.15 mL of trypan blue. Lena says this is 0.6 mL?
The sample and trypan blue is mixed by being dispensed into the cup and drawn back into the syringe as specified in the cell type paramater. The mixed sample is now dispensed through the flow cell for image collection. The remaining sample is dispensed to waste. The flow cell is rinsed and back flushed. The sample vial or well is rinsed with cleaning agent. The flow cell and sample vial or well are rinsed with disinfectant. The flow cell and sample vial or well are rinsed with buffer. The aspiration tube is dried for 1 cycle with air. The sample probe raises from the sample vial or well. The carousel rotates and ejects the sample vial. Vi_CELL BLU Fast Mode The time to complete one cycle in the Vi-CELL BLU Fast Mode is approximately 1:45 minutes. The time to complete is subject to change based upon number of images taken and analysis time. IMPORTANT Vi-CELL BLU Fast Mode requires an accurately measured initial sample volume of 170uL. The carousel rotates and places the sample under the sample probe. The sample probe lowers into the sample. The syringe primes the valve with buffer. The syringe draws in 0.15 mL of trypan blue. The sample and trypan blue is mixed by being dispensed into the cup and drawn back into the syringe as specified in the cell type paramater. The mixed sample is now dispensed through the flow cell for image collection. The remaining sample is dispensed to waste. The flow cell is rinsed and backflushed. The sample vial or well is rinsed with cleaning agent. The flow cell and sample vial or well are rinsed with buffer. The aspiration tube is dried for 1 cycle with air. The sample probe raises from the sample vial or well. The carousel rotates and ejects the sample vial. 1-2 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Measuring Viability And Cellular Parameters 1 Introducing the Vi-CELL BLU Measuring Viability And Cellular Parameters Why Measure Viability?
The measurement of overall health of cell cultures requires accurate measurements of both cell concentration and percentage of viable or live cells. This data is essential to the decision making process for basic tissue culture cell growth and maintaining optimum culture conditions in bioreactors. Historical Perspective The Hemacytometer Cell viability (Trypan Blue Dye Exclusion Method) determinations traditionally have been performed using a light microscope and hemacytometer. Unfortunately, this technique has numerous major shortcomings. The hemacytometer has a significant repeatability error. Different technicians analyzing the same cell sample obtain variations in results. In addition, the manual method is tedious and quite time consuming for todays busy laboratory environment. How Viability is Determined The Trypan Blue Dye Exclusion Method The widely accepted method for cell viability determination is the Trypan Blue Dye Exclusion Method. When cells die, their membranes become permeable allowing for the uptake of the trypan blue dye. As a result, the dead or non-viable cells become darker than the viable cells. This contrast is what is measured in order to determine viability. An Image Analysis Solution The Beckman Coulter Vi-CELL BLU automates the Trypan Blue Dye Exclusion Method. Utilizing video capture technology and sample handling, the Vi-CELL BLU takes the cell sample and delivers it to a flow cell and camera for imaging. The Vi-CELL BLU default setting will capture at least 80 images for its determination of cellular viability. The software determines which cells have absorbed trypan blue dye and those that have not. Cells absorbing the trypan blue dye appear darker hence have lower gray scale values. Cells with higher gray scale values are considered viable. PN C13232AA7 FINAL 1-3 Draft Labeling Subject to Technical Review Introducing the Vi-CELL BLU How Viability is Determined Figure 1.1 Trypan Blue Dye Exclusion Method b c 1. Live cells exclude dye 2. Dye permeable dead cells 1-4 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Introducing the Vi-CELL BLU System Components 1 System Components The following images describe the main components of the Vi-CELL BLU Cell Viability Analyzer. Figure 1.2 Vi-CELL BLU with carousel h g f Vi-CELL BLU b c d e 1. Touchscreen 2. Sample Station 3. Carousel 4. Spent Tube Tray Door 5. Reagent Door 6. USB Ports 7. Power Button PN C13232AA7 FINAL 1-5 Draft Labeling Subject to Technical Review Introducing the Vi-CELL BLU System Components Figure 1.3 Vi-CELL BLU with 96 well plate Vi-CELL BLU b c d 1. Sample Station 2. Plate Holder 3. 96 Well Plate Software Beckman Coulter provides the Vi-CELL BLU software. 1-6 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review CHAPTER 2 Installation and Verification Special Requirements Pre-installation Checks Environment The instrument should be placed on a surface that is not subject to:
1. Excessive airborne dust 2. Strong vibrations 3. Extremes of temperature and humidity Power Requirements WARNING Risk of electric shock and/or instrument damage. Ensure that the power source is properly grounded. Improper grounding can cause electric shock and damage the system. Verify that the output voltage of the power outlet conforms to the system requirements. To prevent personal injury, Beckman Coulter recommends using a power source designed to protect against electrical shock. CAUTION Possible instrument damage could occur if you use an extension cord or a power strip to connect the instrument. Always plug the instrument into a dedicated outlet with an isolated ground. Power: 180 watts max. AC Input: 90-264V AC, 2.5A, 47-63 Hz PN C13232AA7 FINAL 2-1 Draft Labeling Subject to Technical Review Installation and Verification Special Requirements Pre-installation Checks Temperature and Humidity Requirements CAUTION Risk of instrument damage and/or erroneous results. To ensure reliability, the system must be operated in the specified environment, within the required temperature and humidity ranges. If the ambient temperature or humidity level falls outside the ranges mentioned above, use appropriate air conditioning. Temperature: 13 to 37C (55 to 99F) Temperature Variation of: 3C over 8 hours. Humidity: 10 to 90%
Humidity Variation of: 10% over 8 hours Worktable CAUTION Risk of instrument damage. Place the instrument on a level surface. Failing to do so places the system is in danger of toppling and can result in damage. Take all necessary precautions throughout the process of storing or transporting the instrument. The tabletop must be smooth and level. Minimum tabletop load bearing capacity 35 kg (77 lb) 77.16 lbs. 35 kg Vi-CELL BLU 17.8 in 90 cm 3232005AA 35.5 in 45 cm The tabletop must not vibrate or shake. 23.7in 60cm 2-2 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Special Requirements Pre-installation Checks 2 Installation and Verification Position the instrument so that you can disconnect the power cable on the back of the instrument. See Operating and Servicing clearances below. Operating clearances 10 cm (4 in.) clearance right side 5 cm (2 in.) clearance left side 5 cm (2 in.) clearance back of instrument 1 cm (0.5 in.) clearance top of instrument Servicing clearances 20 cm (7.9 in.) clearance right side 20 cm (7.9 in.) clearance left side 20 cm (7.9 in.) clearance back of instrument 70 cm (27.2 in.) clearance top of instrument Ventilation and Cleaning IMPORTANT If necessary, use ventilation equipment, but airflow must not be allowed to blow directly on the instrument, as it can affect the reliability of the data. Ensure that the working environment is well ventilated for proper heat dissipation. Maintain a clearance of at least 20 cm from the back of the instrument for heat dissipation. Keep the environment as dust free as possible. Avoid direct exposure to sunlight. Avoid placing near heat sources or exposing to drafts. Avoid corrosives or flammable gases. PN C13232AA7 FINAL 2-3 Draft Labeling Subject to Technical Review Installation and Verification Installation Installation WARNING Risk of personal injury if only one person lifts the instrument. The instrument has no lifting handles, and it weighs more than one person should lift. Therefore, to prevent injury, at least two people following necessary safety precautions should lift the instrument together. WARNING Risk of personal injury. Use caution when lowering the instrument to avoid pinching fingers. Materials Shipped NOTE The Instrument and Accessory Kit are shipped seperately. Instrument container Vi-CELL BLU Instrument Vi-CELL BLU Quick Start Guide (this manual) Vi-CELL BLU Safety Notices Accessories Kit Power Supply, 90-264 V AC, 220 W, 12V/15A Assy, Ejection Carousel, Vi-CELL BLU Power Cord, 18VBI SVT blk Microfuge Tube, no cap, 350 count 96-Well Plates, 5 count Vinyl Film, 10 count 8mm Hex Allen Wrench, Std L Snap-in Hole Plug, Blk Nyl, 0.750-in. dia 2-4 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Installation and Verification Installation 2 Unpacking WARNING Risk of personal injury if only one person lifts the instrument. The instrument has no lifting handles, and it weighs more than one person should lift. Therefore, to prevent injury, at least two people following necessary safety precautions should lift the instrument together. Use caution when lowering the instrument to avoid pinching fingers. WARNING Risk of personal injury. Use caution when lowering the instrument to avoid pinching fingers. 1. Remove the instrument box from the wooden shipping crate. CAUTION Risk of instrument damage. Place the instrument on a level surface. Failing to do so places the system in danger of toppling and can result in damage. Take all necessary precautions throughout the process of storing or transporting the instrument. 2. Remove the instrument from the instrument box and place the instrument on a bench. 3. Remove the accessories from the accessories box and check the packing list to ensure all the accessory items are included and there is no damage. Notify Beckman Coulter if damage is observed or parts are missing. Worldwide, find us via our website at www.beckmancoulter.com/customersupport/support. In the USA and Canada, call us at 1-800-369-0333. Outside of the USA and Canada, contact your local Beckman Coulter Representative. PN C13232AA7 FINAL 2-5 Draft Labeling Subject to Technical Review Installation and Verification Installation 4. Remove the shipping restraints. a. Remove the large allen bolt on the right side of the instrument with the 8mm allen key from the accessory kit and then cover the hole with the plug from the accessory kit. b. Remove the piece of shipping tape covering the USB ports on the right side of the instrument. Remove the foam insert in the carousel location. c. b d e c Connecting the Instrument 1 Connect the instrument to the power supply module. The power supply Module supports 90-264V AC, 2.5A, 47-63 Hz. 2 Use the appropriate cable to plug the power supply module into an electrical outlet. 3 Install a 96 well plate or a carousel. A1 3232020AA 2-6 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Installation and Verification Installation 2 CAUTION If the system fails to start properly, check first to see whether the power cable and connection cables are properly connected. Never shut off the power or disconnect a data cable while the system is performing a task. Doing so can result in data loss or damage to the system. 4 Press the power button, to turn the instrument on. The software user interface will automatically load. h g f Vi-CELL BLU b c d e 1. Touchscreen 2. Sample Station 3. Carousel 4. Spent Tube Tray Door 5. Reagent Door 6. USB Ports 7. Power Button 5 Follow the instructions for First time Login. PN C13232AA7 FINAL 2-7 Draft Labeling Subject to Technical Review Installation and Verification First time Login First time Login 1 After powering on the instrument the Initializing screen is displayed. 2 Select to login. 3 Enter the default login credentials. Username - bci_admin Password - bci_admin 4 You are prompted to enter a new password. Enter a new password and select See Setup Users for adding additional users. to save. 2-8 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Installation and Verification Home Screen 2 Home Screen After login the home screen is displayed. Figure 2.1 Home screen 1. Select 96 well plate 2. Clear queue 3. Save queue 4. Choose saved queue 5. Exit software Instrument status 6. 7. Reagent status 8. Curreent user 9. Main menu, see Figure 2.2, Main menu PN C13232AA7 FINAL 2-9 Draft Labeling Subject to Technical Review Installation and Verification Home Screen Figure 2.2 Main menu Table 2.1 Main menu buttons Sample queue creation screen to program and run samples. Administration screen to add or change users, assign or change passwords, assign or add cell types and setup the storage size, backup and clean up options. Review sample results to reanalyze, export or sign off the results. View, export and delete a Bioprocess or add a Bioprocess. View, export and delete a Quality Control or add a Quality Control. Setup the system settings, see System Settings. Create, print or export results reports and view or export audit, sample error and calibration log files. Opens the Vi-CELL BLU manual. Displays the Vi-CELL BLU software version number and copyright statement. Sign out the current user without exiting the software. Lock the software user interface. 2-10 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Installation and Verification Install a Reagent Pack 2 Install a Reagent Pack WARNING Risk of biohazardous exposure if you have skin contact with the Reagent Pack waste liquid. The Reagent Pack waste bottle has a vent and the Reagent Pack must be upright whenever you are handling a used Reagent Pack in order to prevent waste liquid from leaking out of the Reagent Pack waste bottle. Clean up spills immediately. Dispose of the Reagent Pack and the solid waste in accordance with your local regulations and acceptable laboratory procedures. Always use the appropriate Personal Protective Equipment (PPE) when working with biohazardous materials. 1 Select and Replace Reagent Pack. 2 Select None and select
.need new screen with None choice PN C13232AA7 FINAL 2-11 Draft Labeling Subject to Technical Review Installation and Verification Install a Reagent Pack 3 The reagent door opens. 2-12 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Installation and Verification Install a Reagent Pack 2 WARNING Risk of biohazardous exposure if you have skin contact with the Reagent Pack waste liquid. The Reagent Pack waste bottle has a vent and the waste bottle must be upright whenever you are handling a used Reagent Pack in order to prevent waste liquid from leaking out of the waste bottle. Clean up spills immediately. Dispose of the Reagent Pack and the solid waste in accordance with your local regulations and acceptable laboratory procedures. Always use the appropriate Personal Protective Equipment (PPE) when working with biohazardous materials. 4 Insert new Reagent Pack. Vi-CELL BLU Manufactured for Beckman Coulter, Inc. C06019 25C 15C Beckman Coulter, Inc. 250 S. Kraemer Blvd. Brea, CA 92821, U.S.A. www.beckmancoulter.com PN C13232AA7 FINAL 2-13 Draft Labeling Subject to Technical Review
1 | C13232AA7 Part2 | Users Manual | 4.86 MiB | November 07 2018 / July 01 2019 |
Installation and Verification Install a Reagent Pack 5 Close the reagent door and select
. 6 Confirm Reagent information and select
. 2-14 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Installation and Verification Install a Reagent Pack 2 WARNING Risk of biohazardous contamination if you have skin contact with the spent tube tray, its contents, and its associated tubing. The spent tube tray and its associated tubing could contain residual biological material and must be handled with care. Clean up spills immediately. Dispose of the contents of the spent tube tray in accordance with your local regulations and acceptable laboratory procedures. 7 Open the spent tube tray door. 8 Remove the spent tube tray. PN C13232AA7 FINAL 2-15 Draft Labeling Subject to Technical Review Installation and Verification System Settings 9 Empty the spent tube tray. 3232009AA 10 Select and
. System Settings and Select There are four System Settings screens General, Instrument, Security and Run Options. to setup the System Settings. 2-16 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Installation and Verification System Settings 2 General Choose your Language Set the Date and Time Instrument Instrument displays the, Serial Number Software Versions Firmware Version Hardware Versions IP Address Device name Display, choose to turn display off after 4 hours of inactivity. NOTE This setting is recommended to extend display life. PN C13232AA7 FINAL 2-17 Draft Labeling Subject to Technical Review Installation and Verification System Settings Security Set Security settings Set Signatures settings Run Options Set up the Default samples Set the Save image locally settings Set the Show Parameters settings Use to arrange the order of the parameters. 2-18 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Installation and Verification Setup Users 2 Setup Users User Administration Add a User NOTE You must be logged in as an administrator to add a user. 1 Select to display the Users list. 2 Select to add a user and, Enter User name Enter Display name EnterPassword Select Role Enable the user Select Analysis type Select Cell types PN C13232AA7 FINAL 2-19 Draft Labeling Subject to Technical Review Installation and Verification Setup Users Select to save User. Edit a User NOTE You must be logged in as an administrator to edit a user. 1 Select to display the users list. 2-20 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Installation and Verification Setup Users 2 2 Select a User and select to edit user information and rights. 3 Select to enter or change user password and select to save changes. My Profile 1 Launch the Vi-CELL BLU software and log in with your username and password. 2 Select to display your user profile. PN C13232AA7 FINAL 2-21 Draft Labeling Subject to Technical Review Installation and Verification Instrument Status 3 Select to enter or change your password and select to save changes. Instrument Status 1 Select to display the Instrument Status. Instrument Performance Verification Daily Verification A control should be run daily to ensure proper instrument performance. The Beckman Coulter Vi-CELL Concentration Controls have been developed for this purpose. 2-22 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Instrument Performance Verification 2 Installation and Verification If the concentration control does not meet the results listed in the Vi-CELL BLU Concentration Control assay sheet:
Ensure that the concentration control cell type is selected in the Vi-CELL BLU software when running concentration control. Verify that the concentration control did not freeze at any time. Freezing results in fragmentation and increased counts. See the Vi-CELL Concentration Control assay sheet for the recommended storage temperatures. The controls will be single use sample tubes. Ensure that the concentration control is handled properly, as proper mixing is crucial to recovery results. Mix the concentration control per the Vi-CELL Concentration Control assay sheet instructions. Do not leave the bottle uncovered for extended periods time as this affects the concentration. If there is debris inside the flow cell, perform the decontamination procedure in APPENDIX E, Replacing Reagents and Decontamination to ensure that the internal components are clean, as debris can affect results. If the debris does not clear after two decontamination attempts, contact us. Try a new, sealed vial of concentration control. If after two attempts the concentration control does not meet the results specified in the Vi-CELL Concentration Control assay sheet, contact us. PN C13232AA7 FINAL 2-23 Draft Labeling Subject to Technical Review Installation and Verification Instrument Performance Verification 2-24 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review CHAPTER 3 Startup Daily Startup WARNING Ensure all doors, covers and panels are closed and secured in place prior to and during instrument operation. WARNING Risk of personal injury from electric shock caused by contacting exposed electronic components. When the Vi-CELL BLU program is run for the first time, the Security Configuration and Preferences should be verified. See System Settings in CHAPTER 2, Installation and Verification for instructions on setting Security Configuration and Preferences. IMPORTANT When you power on the instrument it goes through intialization and home the carousel position. Ensure the carousel does not have any sample vials and a 96 well plate is not installed. 1 Press the power switch on the right side of the instrument. Touchscreen Sample Station Carousel Spent Tube Tray Door Power Button USB Ports Reagent Door 3234002AA PN C13232AA7 FINAL 3-1 Draft Labeling Subject to Technical Review Startup Daily Startup The Initializing screen is displayed. NOTE If Security is not enabled you do not need to login, the Home screen is displayed. Skip to step 4. 2 Select your name to login or browse for your name if it isnt displayed. 3 Enter your login credentials. 3-2 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Setting Up Preferences 3 Startup 4 Select to view instrument status. 5 Select to view reagent status. If you need to add reagents, See Replace Reagent Pack. Setting Up Preferences See System Settings in CHAPTER 2, Installation and Verification for instructions on setting your preferences. PN C13232AA7 FINAL 3-3 Draft Labeling Subject to Technical Review Startup Setting Up Preferences 3-4 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review CHAPTER 4 Run Samples Add Carousel Samples to the Queue WARNING Risk of biohazard contamination. Toxicity, safety, and proper handling procedures for controls and reagents used should be adhered to at all times. To prevent biohazard contamination consult appropriate Safety Data Sheets for the items. WARNING Risk of personal injury. To avoid injury due to moving parts, observe the following:
Never attempt to exchange microcentrifuge tubes while the instrument is operating. Never attempt to physically restrict any of the moving components of the instrument. Keep the instrument work area clear to prevent obstruction of the movement. WARNING Risk of instrument damage or biohazardous contamination due to a misaligned carousel or plate. Misaligned sample carousels or plates can cause the sample container ejection mechanism to jam and spill sample. Ensure the carousel or plate is aligned correctly in the sample station prior to running the sample. Clean up spills immediately. Use universal precautions when working with pathogenic materials. Means must be available to decontaminate the instrument and to dispose of biohazardous waste. Always use the appropriate Personal Protective Equipment (PPE) when working with biohazardous materials. PN C13232AA7 FINAL 4-1 Draft Labeling Subject to Technical Review Run Samples Add Carousel Samples to the Queue 1 Install the carousel and ensure it is secure. 2 Place 200uL +/- 20uL of sample into conical microcentrifuge tubes for Normal Mode and 170uL
+/- 20uL for Fast Mode. NOTE For optimum accuracy, use the specified volume. This is most important during Fast Mode. 3 Select to display the the carousel queue. NOTE If you have previously save a queue that you want to use again select
, select the queue to use, select and skip to step 5. 4-2 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Add Carousel Samples to the Queue 4 Run Samples 4 Enter default sample settings on the Default bar at the top of the screen to use default settings for any position selected or you can enter the Sample ID, Cell Type, Dilution factor and Wash speed for each carousel position to add samples to the carousel queue. NOTE You can drag-select multiple sample positions in one motion. 5 After all of the samples are programmed, select position. If you want to save the queue for use in the future, select
. to advance the carousel to the loading 6 Load the sample tubes onto the carousel as per the queue and select
. The carousel advances to the run position. 7 Select to run the carousel. PN C13232AA7 FINAL 4-3 Draft Labeling Subject to Technical Review Run Samples Add 96 Well Plate Samples to the Queue 8 The carousel sample results,
, are displayed. On this screen you can choose to, Display camera results Display graph results Annotate the results Export the results Display the results fullscreen Add 96 Well Plate Samples to the Queue WARNING Risk of biohazard contamination. Toxicity, safety, and proper handling procedures for controls and reagents used should be adhered to at all times. To prevent biohazard contamination consult appropriate Safety Data Sheets for the items. 4-4 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Add 96 Well Plate Samples to the Queue 4 Run Samples WARNING Risk of personal injury. To avoid injury due to moving parts, observe the following:
Never attempt to exchange labware, reagents, or tools while the instrument is operating. Never attempt to physically restrict any of the moving components of the instrument. Keep the instrument work area clear to prevent obstruction of the movement. WARNING Risk of pinch-point injury when using 96 well plates. Keep your hands away from moving parts. The instrument contains probes and moving parts. The probes are sharp and the probe motor is strong enough to cause the probe to puncture your skin. The probe may contain biohazardous materials, including controls and blood samples. The probe is in motion during many types of instrument cycles such as startup and shutdown, not just during sample analysis. 1 Place 200uL +/- 20uL of sample of sample into the appropriate wells of a 96 well microplate. PN C13232AA7 FINAL 4-5 Draft Labeling Subject to Technical Review Run Samples Add 96 Well Plate Samples to the Queue 2 Install the 96 well microplate on the plate holder and ensure it is secure. A1 3 On the Home screen, select to switch to the 96 well microplate queue. 4 Enter default sample settings on the Default bar at the top of the screen to use default settings for any position selected or you can enter the Sample ID, Cell Type, Dilution factor and Wash speed for each each well position to add samples to the queue. NOTE If you have previously save a queue that you want to use again select
, select the queue to use, select and skip to step 6. 4-6 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review
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Add 96 Well Plate Samples to the Queue 4 Run Samples 5 Select to finish programming the 96 well microplate. 6 Select to run the 96 well microplate queue. 7 Plate results list. 8 Plate sample results. PN C13232AA7 FINAL 4-7 Draft Labeling Subject to Technical Review Run Samples Run Results Run Results Green Screens need to be replaced throughout Camera image results. Graphical results. Carousel cell type, count and viability results. 4-8 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Plate cell type, count and viability results. Run Samples Run Results 4 Camera Image Options Grey level histogram, Image fit to window. Grey level histogram, Image actual size. PN C13232AA7 FINAL 4-9 Draft Labeling Subject to Technical Review Run Samples Run Results Annotated image, Image fit to window. Binary image, Image fit to window. Annotated and Binary image, Image fit to windows. 4-10 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Grey level histogram. Run Samples Run Results 4 PN C13232AA7 FINAL 4-11 Draft Labeling Subject to Technical Review Run Samples Bioprocess Results Bioprocess Results Green Screens need to be replaced throughout What Is A Bioprocess?
A bioprocess consists of the analysis results of a number of samples taken from the same source over a period of time. The source might be a bioreactor, a fermentation vessel or even a laboratory flask. A source may be associated with many bioprocesses as when one bioprocess finishes (for example when a bioreactor is harvested) then another separate bioprocess can be started. The measurements associated with a single bioprocess can be manipulated (opened and closed) as if they were a single entity. The Vi-CELL BLU is designed to make it easy to monitor multiple, asynchronous, bioprocesses at the same time. Changes in selected analysis parameters over time can be displayed making it easy for example to check the progress of a bioreactor and to choose the optimum time for harvest. The Vi-CELL BLU bioprocess feature allows convenient, automated tracking of any of the measured cell culture parameters and calculates growth rate, doubling time, all essential to optimum bioreactor productivity. Data points are recorded and stored, eliminating the necessity for manual recording of the cell culture measurements. See. Growth Rate and Doubling times are calculated from the results of the last two runs using the formulas:Colin asks if Vi-Cell BLU does this Growth rate per hour = ( ln V2 - ln V1 ) / ( t2 - t1 ) Doubling time in hours= ln 2 / Growth rate per hour Where V1 = Viable cell concentration in cells/mL at elapsed time t1 in hours V2 = Viable cell concentration in cells/mL at elapsed time t2 in hours Bioprocess list results. 4-12 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Bioprocess Results 4 Run Samples Add Bioprocess screen. Bioprocess Total Cells/mL results. Bioprocess camera results. PN C13232AA7 FINAL 4-13 Draft Labeling Subject to Technical Review Run Samples Signoff Results Bioprocess size distribution results. Signoff Results Green Screens need to be replaced throughout 1 When Security is enabled, you need to select to signoff results after sample processing. 2 Enter your User Name and Password and select Creation (CRE) Review (REV) or Approve (APR).. 4-14 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Signoff Results 4 Run Samples 3 Your approval credentials are shown on the Run Result screen. PN C13232AA7 FINAL 4-15 Draft Labeling Subject to Technical Review Run Samples Signoff Results 4-16 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review CHAPTER 5 Data Analysis Reviewing/Reanalyze Data 1 Select and to choose a file to review. 2 Select a sample to review or reanalyze and select
. 3 If desired, change the Cell Type,. PN C13232AA7 FINAL 5-1 Draft Labeling Subject to Technical Review
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Data Analysis Import Results Import Results Green Screens need to be replaced throughout 1 Select to import results for reanalysis. 2 Select the file to reanalyze. 5-2 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Import Results 5 Data Analysis 3 Select to edit the sample file. 4 Select to saved the edited sample file. PN C13232AA7 FINAL 5-3 Draft Labeling Subject to Technical Review Data Analysis Export Results Export Results Green Screens need to be replaced throughout 1 Select a run and select to export results. 2 Select the export destination, enter a file name and file path. 3 Select Print, Graph and Camera options to export. 5-4 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Export Results 5 Data Analysis 4 If desired, select to Merge with existing excel file. PN C13232AA7 FINAL 5-5 Draft Labeling Subject to Technical Review Data Analysis Export Results 5-6 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review CHAPTER 6 Software Administration Cell Type Administration What is a Cell Type?
Cell types are files that store the optical settings required to correctly identify and quantify viable versus non-viable cells. Cells will vary in their optical characteristics and understanding how to establish the correct settings is important. For many cell types, the default cell type values are suitable. In the event any of the parameters must be changed for a given sample, a new cell type may be created or an existing one modified. This section provides the instructions for creating new cell types for use with the software. The Vi-CELL BLU software has 4 cell types predefined, and are intended to be used as starting points for additional customer-defined cell types. Enter the appropriate information for the particular cell type and dilution factor as necessary. Use the default settings as a starting point if necessary. Use the minimum diameter parameter for excluding cellular debris or unwanted cells. Use the mixing cycle to adjust for cell lines that tend to shear under the stress of mixing. For insect cell lines, a mixing cycle of 1 is found to be suitable. Cell Type Screen 1 Select
>
>
to view the Cell type screen. PN C13232AA7 FINAL 6-1 Draft Labeling Subject to Technical Review Software Administration Cell Type Administration 2 Select to add or edit a Cell type. 3 Enter the The Minimum and Maximum size of cells within the sample. Any cells that fall outside of this range are ignored. They will appear within the camera image but will not be annotated and will not be included in any of the numerical run results. The minimum diameter can be used to exclude debris and/or unwanted cells. The size range should be used only to specify the expected range of cell sizes within the sample and should not be used to identify sub ranges. 4 Enter the number of Images (1 to 100). A larger number will give a statistically better result. However a smaller number can be used if cycle time and image storage requirements are more important than absolute accuracy. 5 Enter the Cell Sharpness. Cell Sharpness the clarity of an image and specifies the minimum sharpness at the outer edge of a cell. This setting affects the focus discrimination algorithm. A higher value will require a more sharply-defined cell, to be accepted. Enter a range from 1 to 200. 1 represents sharpest, 200 unclear. This value also affects the transition from cell boundary (dark) to light
(background). 6 Enter the Min circularity.
(Least Circular=O, Perfectly Circular=l). This parameter can be used to reject debris that exceeds the minimum cell diameter and are too irregularly shaped to be treated as a real cell. All objects with original (pre-fit) circularity less than this value will be ignored in the analysis. Raise this value to bypass debris more easily. 6-2 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Software Administration Cell Type Administration 6 7 Enter the Decluster degree. The default setting is medium. This function increases the ability of the software to detect cells that are clumped together. Set the de-cluster degree according to how well the cell clusters appear within the images (if not de-clustered properly). Generally, a higher value will identify more cells within a cluster, but a higher value may also split a single non-circular cell into more than one cell. If the cells in a sample are circular, a higher value can be safely used. High will perform the most aggressive declustering; Low will perform the least aggressive declustering. If individual cells are being split into 1 or more cells by the declustering, set this value to Medium or Low. 8 Enter the Aspiration Cycles. In order to ensure that all of the cells are equally dispersed some of the sample is aspirated and then returned to the cup. One cycle is normally sufficient but if the cells are difficult to keep in suspension and have a tendency to attach themselves to the walls of the cup then additional aspirate cycles may be beneficial. NOTE Cells must be in single cell suspension prior to placement on the system. 9 Select the Analysis type from the pull-down menu. 10 Enter the Viable spot brightness. This is the brightness of the center spot of the cell. This is a percentage of the grayscale range. Cell centers must be higher (lighter) than this percent to be counted as viable. This parameter is expressed as a percentage of the background intensity. 75% is a typical value. Pixels in the center of a cell that are brighter than this setting are considered to be part of the center spot. For latex beads the viable cell spot brightness should not be set less than 75%. NOTE The cell brightness and sharpness help determine whether or not the boundary dark pixels belong to a cell or are part of the background. The cell spot brightness and area determine whether or not a cell is viable or non-viable. PN C13232AA7 FINAL 6-3 Draft Labeling Subject to Technical Review Software Administration Reports Administration 11 Enter the Viable spot area. The cell spot area is a percentage of the total area of the Cell. The bright center spot must be larger than this, as a percent of the total area, to be considered viable. 5 to 10% are typical values. Any extremes in this value will either make the cells all viable or non-viable. If the area of the center spot (as determined from the viable cell spot brightness) is greater than this percentage of the total area contained within the outer edge of the cell (as determined from the cell sharpness), then the cell is considered to be viable. 12 Enter the Mixing cycles. The trypan blue and sample are mixed by sending the mixture back and forth between the sample cup and syringe. This parameter determines the number of times that the mixture is returned to the cup. Normally three times is sufficient but if the sample is immiscible with trypan blue then a higher value may be necessary to achieve good mixing and even background intensities. This feature is especially useful for cell types, which may shear due to excessive mixing. Lowering the number of mixing cycles will alleviate this situation. For insect cell lines, it has been determined that 1 mixing cycle is most suitable. 13 Select to save the new or edited Cell type. Reports Administration Report Results Completed Run Summary Reports 1 Select
>
to view the Report Results screen. The Completed run summary report screen is displayed by default. You can choose to create other reports. Use the links below to create other reports. Run Results Reports. Bioprocess Reports. Quality controls Reports Cell type Reports 6-4 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Software Administration Reports Administration 6 Instrument Reports 2 On The Completed run summary report screen, Select the User name. Select the From and To dates. Select your Print Options. Enter a Print title. Enter any additional Comments. 3 Select to save the report as PDF or select to Export the report. Run Results Reports 1 Select
>
to view the Report Results screen. 2 Select Run Results. PN C13232AA7 FINAL 6-5 Draft Labeling Subject to Technical Review Software Administration Reports Administration 3 Select to choose a file for the report. Select a User name. Select the From and To dates. Select
. Select a listing in the Work Queue. Select a Sample from the Sample ID list. Select
. 4 On The Run Results screen, Select your Print Options. Enter a Caption if required. Enter a Print title. Enter any additional Comments. 6-6 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Software Administration Reports Administration 6 5 Select to save the report as PDF or select to Export the report. Bioprocess Reports 1 Select
>
to view the Report Results screen. 2 Select Bioprocess. 3 Select to choose a Bioprocess file for the report. Select a Bioprocess file. Select
. 4 On the Bioprocess report screen, Select your Bioprocess sample IDs. Enter a Print title. PN C13232AA7 FINAL 6-7 Draft Labeling Subject to Technical Review Software Administration Reports Administration Enter any additional Comments. 5 Select to save the report as PDF or select to Export the report. Quality controls Reports 1 Select
>
to view the Report Results screen. 2 Select Quality controls. 6-8 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Software Administration Reports Administration 6 3 Select to choose a Quality control file for the report. Select a Quality control file. Select
. 4 On the Quality controls screen, Enter a Print title. Enter any additional Comments. 5 Select to save the report as PDF or select to Export the report. PN C13232AA7 FINAL 6-9 Draft Labeling Subject to Technical Review Software Administration Reports Administration Cell type Reports 1 Select
>
to view the Report Results screen. 2 Select Cell type. 3 On The Cell type screen, Select a User name. Select your Cell type options. Enter a Print title. Enter any additional Comments. 4 Select to save the report as PDF or select to Export the report. 6-10 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Software Administration Storage Administration 6 Instrument Reports 1 Select
>
to view the Report Results screen. 2 Select Instrument status. 3 On The Instrument status report screen, Select your Print Options. Enter a Print title. Enter any additional Comments. 4 Select to save the report as PDF. Storage Administration Storage Administrations screen. PN C13232AA7 FINAL 6-11 Draft Labeling Subject to Technical Review Software Administration User Types and Access Levels User Types and Access Levels The types of user rolls on the instrument are: Normal, Advanced and Admin. When instrument security is disabled, feature availability is as described in the Security OFF column and individual user roles are not used. Refer to Table 6.1 for a list of software features and sub features that are enabled (
disabled/read-only (
) for each user type.
), and hidden (
), Table 6.1 User Types and Access Levels Features Sub Features Normal User Advanced User Admin User Security OFF Home Queue Creation Run Results Signature Admin - Users Add/Edit/Delete Enable/Disable User Change password -
Self Reset Password - All Users Add/Edit.Delete Admin - Cell Types Admin - Storage View Storage Info Delete Shared Folder System Backup System Cleanup Reports Logs Results - Self Results - All Users Instrument Status Report Reanalyze Signature Review 6-12 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review User Types and Access Levels 6 Software Administration Table 6.1 User Types and Access Levels Features Sub Features Normal User Advanced User Admin User Security OFF Bioprocess Add BP Delete BP Export Results View Results Quality Controls Add QC Delete QC Export Results View Results Language Date & Time Security Signature Settings Run Options - Self Show in Results Options - Self Conc/Size Calibration Low Level Controls Set Focus Dust Reference Motor Reg Reagent Containers 1, 2, 3 Alcohol, CLENZ, Buffer Names Alcohol, CLENZ, Buffer Details Settings Maintenance Reagents My Profile - Self Help About PN C13232AA7 FINAL 6-13 Draft Labeling Subject to Technical Review Software Administration User Types and Access Levels Table 6.1 User Types and Access Levels Features Sub Features Normal User Advanced User Admin User Sign In/Sign Out Minimize and Exit Software Inactivity Timeout/System Lock a. Service sign in on long press if security=off. Security OFF a N/A 6-14 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review CHAPTER 7 Quality Control What Is The Control Feature?
The control feature monitors Vi-CELL BLU performance. The accuracy of concentration measurements (Total Cells/mL) can be checked using Vi-CELL BLU obtained from Beckman Coulter. PN C09148 2 M Concentration Control PN C09149 4 M Concentration Control PN C09150 10 M Concentration Control PN XXXXX L10 size control PN C18061 Viability control The instrument contains special software that makes it very easy to run the control sample and to store and review the results obtained. A collection of results from the same control sample are grouped together and can be saved, exported, printed as a single entity called a control (opened, closed etc.). The Vi-CELL BLU is supplied with a control already created to check concentrations. Run a Concentration Control Green Screens need to be replaced throughout 1 Select to display the Quality Control screen and select a control file. PN C13232AA7 FINAL 7-1 Draft Labeling Subject to Technical Review Quality Control Run a Concentration Control 2 If desired, select to Add Quality Controls. 3 Select to run the Control. 4 Quality Control Total Cells/mL results. 5 Quality Control Camera results. 7-2 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Run a Concentration Control 7 Quality Control 6 Quality Control Size Distribution results. PN C13232AA7 FINAL 7-3 Draft Labeling Subject to Technical Review Quality Control Run a Concentration Control 7-4 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review CHAPTER 8 Regulatory Compliance 21 CFR Part 11 21 CFR Part 11 The Electronic Records and Electronic Signatures Rule (21 CFR Part 11) was established by the FDA to define the requirements for submitting documentation in electronic form and the criteria for approved electronic signatures. This rule, which has been in effect since August 20, 1997, does not stand in isolation; it defines the standards by which an organization can use electronic records to meet its record-keeping requirements. Organizations that choose to use electronic records must comply with 21 CFR Part 11. It is intended to improve an organizations quality control while preserving the FDAs charter to protect the public. Since analytical instrument systems such as the Vi-CELL BLU Cell Viability Analyzer, generate electronic records, these systems must comply with the Electronic Records Rule. This section describes the relevant portions of the 21 CFR Part 11 regulations and their implementation using the Vi-CELL BLU control software. The implementation and compliance of 21 CFR Part 11 remains the responsibility of the organization or entity creating and signing the electronic records in question. Proper procedures and practices, such as GLP and GMP, are as much part of the overall compliance with these regulations as are the features of the Vi-CELL BLU control software. Electronic Records Per Section 11.3 subpart A of 21 CFR Part 11, an electronic record is any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved or distributed by a computer system. This refers to any digital computer file submitted to the FDA, or any information not submitted but that needs to be archived. Public docket No. 92S-0251 of the Federal Register (Vol. 62, No. 54) identifies the types of documents acceptable for submission in electronic form and where such submissions may be made. PN C13232AA7 FINAL 8-1 Draft Labeling Subject to Technical Review Regulatory Compliance 21 CFR Part 11 FDA Requirements FDA Requirements The general comments section of the ruling states that The agency emphasizes that these regulations do not require, but rather permit, the use of electronic records and signatures. The introduction to the final ruling states that The use of electronic records as well as their submissions to FDA is voluntary. If electronic submissions are made, Section 11.2 explains that persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures provided that: (1) The requirements of this part are met; and (2) The document or parts of a document to be submitted have been identified in public docket No. 92S-0251. The Vi-CELL BLU control software has been designed to allow users to comply with the electronic records and signatures rule. Any organization deciding to employ electronic signatures must declare to the FDA their intention to do so. Implementing Electronic Records and Signatures Section 11.3 Subpart A describes two classes of systems:
Closed Systems A closed system is one in which system access is controlled by persons who are responsible for the content of electronic records. In other words, the people and organization responsible for creating and maintaining the information on the system are also responsible for operating and administering the system. Open Systems An open system is one in which system access is not controlled by persons who are responsible for the content of electronic records. The Vi-CELL BLU control software is designed to ensure the proper operation, maintenance and administration for system security and data integrity. Anyone who interacts the Vi-CELL BLU, from administrators to users, must abide by these procedures. Therefore the ultimate responsibility is with the organization generating electronic records and signatures. The Vi-CELL BLU software is a component, albeit a vital one, of the overall process. Controls for Electronic Records Subpart B, Section 11.10 describes the controls to be applied to a "closed system". Section 11.30 describes the controls for an "open system", which include "those identified in Section 11.10, as appropriate, and additional measures such as document encryption and use of appropriate digital signature standards". Since a typical Vi-CELL BLU system can be regarded as a closed system, additional controls for open systems will not be discussed in this document. The primary thrust of these controls is "to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine". In other words, to protect the data and to make it difficult for someone to say that 8-2 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Regulatory Compliance 21 CFR Part 11 Establishing an Electronic Record 8 this is not their "signature". Many of the controls described in Section 11.10 refer to written procedures (SOPs) required of an organization by the agency, for the purpose of data storage and retrieval, access control, training, accountability, documentation, record keeping, and change control. The other controls are addressed either by the Vi-CELL BLU software itself, or in combination with end-user procedures. Of the other controls, perhaps the foremost is described in Section 11.10 Paragraph (a): "Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records." It is the complete and overall validation of the system, as developed by the organization, which ensures the integrity of the system and the data within. It is to this end that the features of the Vi-CELL BLU software comply with the specifications of these regulations. Establishing an Electronic Record The Vi-CELL BLU software employs a system of usernames and passwords, consistent with the specifications of Subpart C, Section 11.300, "to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand". 21 CFR Part 11 Security To turn on the security option, select.... TBD NOTE Inactivity timeout is set to prevent unofficial access to the system, as when the system is left unattended directly after starting the queue. The system will prompt you to log in. On the Log In dialog, enter your user name and password. New users can only be created and passwords reset by users with Administrator rights. This file is protected with a checksum and for each user name, contains information on when the user was created, by whom, at what level, the users password in encrypted form and the users file paths. If this file does not exist or if the checksum is missing or invalid then access to the system will only be possible to a limited number of special users. File History The Vi-CELL BLU software also performs data input and "operational checks", as specified in Subpart B, Section 11.10, "to determine, as appropriate, the validity of the source of data input or operational instruction", and "to enforce permitted sequencing of steps and events". These two features ensure that, as much as possible, valid data are being entered into the system, and all required steps have been completed to perform the task at hand. The purpose of all such data checking and validation is described in Section 11.10, Paragraph (b):
"The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency". Vi-CELL BLU software data files are all automatically saved upon creation and protected with a checksum. Vi-CELL BLU software also allows for the capability for backing up data to mirror directories. PN C13232AA7 FINAL 8-3 Draft Labeling Subject to Technical Review Regulatory Compliance 21 CFR Part 11 Establishing an Electronic Record Section 11.10, paragraph (e) requires use of secure computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Such audit trail documentation must be retained for a period at least as long that required to for the subject electronic records and must be available for agency review and copying. The Vi-CELL BLU software complies with this rule by generating an audit trail which records the time a user was logged on. The audit trail is encrypted and checksummed for added security. The audit trail also will record and time-stamp: failed login attempts, switching users, turning security on or off, adding new user, enable/disable user, change password, reset password, lock instrument and failed checksums. When a data file is created, the Vi-CELL BLU system software provides a computer-generated time-stamped record that documents actions taken to create a record. This information is stored within the actual data file itself, not in the Audit Trail file. Each data file contains a computer-generated time-stamped record, the date and time of operator entries, and the actions taken to create the data file. The system software does not allow a data record to be modified or deleted within the normal operation of the system software. If the integrity of a data file is compromised in some way, the file is rendered unusable by the system and it can no longer be used by the Vi-CELL BLU software. Each data file contains an embedded checksum that is used to check the integrity of the file each time the file is loaded. If the data file is compromised, an error message is displayed and the file does not load. Electronic Signature In Subpart A, Section 11.3, an electronic signature is defined as "a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individuals handwritten signature". Subpart C, Section 11.100 of the regulation defines the general requirements of such a manifestation. Paragraph (a) states that
"each electronic signature must be unique to one individual and must not be reused by, or reassigned to, anyone else". These two paragraphs, taken together, mean that an electronic signature is some computer representation of a users identity, developed to ensure the distinct and unique identity of that user. The procedural aspect of Section 11.100 requires that before any such electronic representation is applied, the organization first must "verify" the identity of that individual. The subsequent use of electronic signatures as the "legally binding equivalent of traditional handwritten signatures" then must be "certified" to the agency in writing. Subpart C, Section 11.200, refers to biometric and non-biometric forms of electronic signature. Biometric signatures are defined in Subpart A, Section 11.3 as a "a method of verifying an individuals identity based on measurement of the individuals physical feature(s) or repeatable action(s) where those features and/or actions are both unique to that individual and measurable". Biometrics are generally regarded as techniques such as fingerprints or retinal scans, which are considered to be totally unique to each individual and require specific forms of scanning devices to read and interpret. Non-biometric signatures are those that are computer generated and, as per Section 11.200, "Employ at least two distinct identification components such as an identification code and password". It is this form of electronic signature that is supported by the Vi-CELL BLU software. 8-4 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Regulatory Compliance 21 CFR Part 11 Establishing an Electronic Record 8 Generating Electronic Signatures The Vi-CELL BLU software employs User IDs and passwords to verify the identification of each user logging into the system. When using this technique, Subpart C, Section 11.300 of the regulation requires "maintaining the uniqueness of each combined identification code and password, such that no two individuals have the same combination of identification code and password". This section also requires that the "identification code and password issuances are periodically checked, recalled, or revised". Vi-CELL BLU software supports both of these provisions. The administration of the system requires that individuals are added to the list of valid Vi-CELL BLU users via the Add a New User dialog box. The "identification code" or username of each Vi-CELL BLU user must be unique. No two users on the same Vi-CELL BLU system can have the same user name. It is also required that these users supply a password to access the Vi-CELL BLU software, thus satisfying the requirement to "employ at least two distinct identification components such as an identification code and password". Passwords can be controlled to prohibit the use of duplicates and to force the selection of new passwords after a prescribed period of time. By the implementation of these features, the Vi-CELL BLU software can satisfy the requirement that
"identification code and password issuances are periodically checked, recalled, or revised". Applying Electronic Signatures Subpart C, Section 11.200 stipulates several requirements for the control of electronic signatures. Procedurally, the regulations require that electronic signatures "be used only by their genuine owners" and that they "be administered and executed to ensure that attempted use of an individuals electronic signature by anyone other than its genuine owner requires collaboration of two or more individuals". Through the application of Vi-CELL BLU user and password configuration procedures, the system can be configured to "ensure" that inappropriate use of these identifiers can be performed only by the intentional divulgence of security information. Section 11.200 further specifies the use of electronic signature components during a period "when an individual executes a series of signings during a single, continuous period of controlled system access", and "when an individual executes one or more signings not performed during a single, continuous period of controlled system access". This section of the document represents the
"heart" of electronic signature application. To comply with these provisions, the Vi-CELL BLU software uses the application of the username and password to authenticate the user making and saving the changes, in conjunction with file history. PN C13232AA7 FINAL 8-5 Draft Labeling Subject to Technical Review Regulatory Compliance 21 CFR Part 11 Establishing an Electronic Record 8-6 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review APPENDIX A System Specifications Data Acquisition Need to verify these specs Operating principle: analysis of video images Sample type: spatial data Cell size range of 2 microns to 60 microns Analysis rate: up to 100 Images in 130 seconds Digitizing resolution: 2048x2048 Cell Viability/Concentration/Cell Count Need to verify these specs Concentration Range: 5 x 104 to 15 x 106 Cells/mL Viability Range: 0 to 100%
Mean Recovery Value of 20 replicates of Concentration Control on Vi-CELL BLU compared to the lot assay value used are 6%. NOTE The results for samples at the low end of the concentration range will not be as statistically accurate due to the low number of measured cells. The accuracy at the high end of the concentration range is affected by the difficulty of declustering groups of cells particularly if the cells are large. The sample should be diluted to bring its concentration into range or to improve the accuracy of the results Physical Requirements Power 50 watts (180 watts max.) Voltages 90-264V AC, 47-63 Hz Temperature: 13 to 37C (55 to 99F) Temperature Variation of: 3C over 8 hours. Humidity: 10 to 90%
Humidity Variation of: 10% over 8 hours PN C13232AA7 FINAL A-1 Draft Labeling Subject to Technical Review System Specifications Unit Dimensions Unit Dimensions 77.16 lbs. 35 kg Vi-CELL BLU 17.8 in 90 cm 3232005AA 35.5 in 45 cm 23.7in 60cm A-2 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review APPENDIX B Service and Maintenance Focusing Wizard A focusing wizard is provided that automatically checks and if necessary adjusts the focus. Selecting the set focus item in the diagnostic menu and using the Vi-CELL BLU Focus Control that is supplied with the instrument (or can be supplied by Beckman Coulter) begins the process. Focus should be run if images are clearly out of focus or a size control fails specification. Set Focus 1 Select and carousel (or A1 position in the 96 well plate). and place a cup of focus control into the empty position in the 2 Place a cup of focus control into the empty position in the carousel (or A1 position in the 96 well plate). PN C13232AA7 FINAL B-1 Draft Labeling Subject to Technical Review Service and Maintenance Calibration Control 3 Wait while the Focus Control sample is being processed. 4 Choose to accept the new focus position. 5 After cleaning is complete, select to exit Set Focus. Calibration Control NOTE To perform Calibration, you must be logged in as Administrator and have access to a vortexer and a microcentrifuge. 1 Select and and and select a control. 2 Following the instructions listed on the screen, enter the assay value, lot number, and expiration date for each of the concentrations of Vi-CELL Concentration Control beads. B-2 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Service and Maintenance Calibration Control B 3 To prepare the bead samples, vortex each tube for approximately 10 seconds both right side up and upside down. Place the tubes in a microcentrifuge, ensuring they are evenly spaced so as to keep the centrifuge balanced, and centrifuge them at 2000 rcf for 10 seconds. 10 tubes of the 2M Control, 5 tubes of the 4M Control, and 3 tubes of the 10M Control should be prepared. 4 Remove the caps from all of the tubes and load the tubes into the carousel to match the on-screen carousel diagram. The 2M Control will be in positions 1-10, the 4M Control will be in positions 11-15, and the 10M Control will be in positions 16-18. 5 Select
. 6 When all the tubes have been run and the calibration equation has been calculated select to accept the new calibration. 7 Review the, Calibration Concentration results screen Calibration Concentration camera screen Calibration Concentration graph screen Calibration Size results screen Calibration Size camera screen Calibration Size graph screen PN C13232AA7 FINAL B-3 Draft Labeling Subject to Technical Review Service and Maintenance Calibration Control B-4 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review APPENDIX C Statistics Circularity Verify the definition and equation for circularity are correct A value from 0 to 1, with 1 representing a perfect circle. Computed as Da/Dp, where Da = square root (4 A / ), Dp = P / ; A = pixel area, P = pixel perimeter. The circularity distribution is based on individual cells, not cells that are part of clusters. System Performance Run Statistics Cell Count The actual number of cells recorded per frame and for the total number of frames. Viable Cells The number of viable cells per image and for the total number of images. Viability The percentage of viable cells per image and for the total number of images. Total Cells/mL The concentration of cells per mL. Viable Cells/mL The concentration of viable or live cells per mL. Avg. Diameter The average size of cells per image and for total images. Avg. Circularity The average roundness of the cells. Images The total number of images analyzed. Average Cells/Image The number of cells captured per image. Background Intensity The average pixel value, from 0 to 255, of the image background. Effective Field of View Effective Field of View is the size of the area inside the reduced measurement frame, and it most accurately represents the actual counting area. It is the area that should be used in computing cell concentrations. PN C13232AA7 FINAL C-1 Draft Labeling Subject to Technical Review Statistics Effective Field of View The Effective Field of View value in the configuration or calibration screens permits you to calculate concentrations to verify them against reported values. Is this graphic accurate for Vi-CELL BLU?
The border zone indentations on the top and left border of the image are used to correct for the effect whereby larger objects are more likely not to be because of contact with an edge of the image. That effect introduces a bias into size distributions and concentration results, and the indents are a way to correct for it. Objects intersecting the bottom or right edge are not counted. Objects that are partially in the main counting area and partially in the border zone are counted. Objects that are entirely within the border zone are not counted. With this method, larger objects that would have gotten rejected are now counted. Smaller objects are not affected (the correction varies in proportion to particle size). The border indent is 30 microns, which is large enough to handle all actual cell sizes that are encountered. C-2 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review APPENDIX D Troubleshooting Troubleshooting Table Table D.1 through Table D.6 lists problems that the operator could encounter while running the Vi-
CELL BLU instrument, the probable causes of each problem, and the corrective actions. These problems are split into individual tables for each system affected. These problems are listed alphabetically in the Index, under the primary entry troubleshooting. IMPORTANT This troubleshooting table contains the same information given to the instrument operators in the instruments Instructions for Use, plus service only actions. Links to procedures that are live in the Instructions for Use are replaced in this manual by references to the correct section in the Instructions for Use. Leaving in the action to contact us lets you know how much a customer is expected to do before calling service. IMPORTANT There are four different severities catalogued by the system:
Notification. This means no special attention is required. Warning. This means the system is operational, but requires special attention. Error. This means the system is inoperative, but recoverable. Fatal. This means the system is inoperative and the error is not recoverable. NOTE A particular failure mode can potentially display any level of severity depending on whether or not the system was able to self-correct the problem or not. Table D.1 Troubleshooting Table - Instrument Problem Subsystem: General Missing component Logic error Probable Cause Corrective Action Loose/disconnected cable Hardware failure Software error Customer 1. Contact us. Customer 1. Contact us. Subsystem: Configuration Configuration not found Hard disk corruption Software error Calibration not found Disk degredation Software error Configuration lost because of software update If the problem persists, contact us. Customer 1. Restart the system. 2. Customer 1. Restart the system. 2. Recalibrate the sampler system. Refer to IFU procedure. 3. Refocus the optics. Refer to IFU procedure. If the problem persists, contact us. 4. PN C13232AA7 FINAL D-1 Draft Labeling Subject to Technical Review Troubleshooting Troubleshooting Table Table D.1 Troubleshooting Table - Instrument Probable Cause Corrective Action Problem Subsystem: Database No connection Disk degredation Software error Insert error Not enough disk capcity Database is corrupt Disk drive failure Retrieve error Invalid reference UUID Database is corrupt Disk drive failure Subsystem: Storage Read error Disk drive failure Write error Disk drive failure Customer 1. If you are using a remote database, check the network connection. If the problem persists, contact us. 2. Restart the system. 3. Customer 1. Navigate to the System Status dialog and verify the available disk capacity. Refer to System Status in Chapter 2, Installation and Verification of the Instructions for Use manual. 2. Backup system data and remove from the system volume. refer to ifu procedure 3. Clear the exported data folders on the instrument. refer to ifu procedure If the problem persists, contact us. 4. Restart the system. 5. Customer 1. Verify available disk capacity in the System Status dialogs. Refer to IFU procedure 2. Restart the system. 3. If the problem persists, contact us. If the problem persists, contact us. Customer 1. Restart the system. 2. Customer 1. Restart the system. 2. If the problem persists, contact us. Near Capacity System storage is near capacity Customer 1. Backup system data and remove from the system volume. refer to ifu procedure 2. Clear the exported data folders on the instrument. refer to ifu procedure D-2 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Troubleshooting Table D Troubleshooting Table D.1 Troubleshooting Table - Instrument Problem Subsystem: Integrity Verification on read Probable Cause Corrective Action Disk drive failure Customer 1. Restart the system. 2. Restore the system from the last archive. Refer to IFU procedure. If the problem persists, contact us. 3. Table D.2 Troubleshooting Table - Controller Board (Main Board) Problem Subsystem: General Connection Error Probable Cause Corrective Action Unable to connect to main board. Customer 1. Power cycle the system by unplugging the Analyzer and plugging it back in. 2. Turn on the Analyzer. 3. If the problem persists, contact us. Subsystem: Communication Host Comm Error Main board failure Problem with firmware Problem with communication chips Subsystem: Firmware Firmware Update Error Firmware Bootup Error Invalid Firmware Version Corrupt firmware update file Main board failure Corrupted firmware image on the main board. Main board failure Incorrect firmware version Table D.3 Troubleshooting Table - Reagents Probable Cause Problem Subsystem: General Subsystem: RFID Hardware Hardware Error Customer 1. Contact us. Customer 1. Contact us. Customer 1. Contact us. Customer 1. Contact us. Corrective Action Component failure Loose or faulty wiring between the main board and the RFID board. Customer 1. Restart the system. 2. Replace the reagent pack. Refer to IFU procedure. If the problem persists, contact us. Subsystem: Bay Hardware Main board failure 3. PN C13232AA7 FINAL D-3 Draft Labeling Subject to Technical Review Troubleshooting Troubleshooting Table Table D.3 Troubleshooting Table - Reagents Problem Sensor Error Latch Error Probable Cause Door or pack presence sensor failure Faulty wiring Unable to actuate the door latch Reagent door latch solenoid failure Faulty wiring to reagent door latch solenoid Main board failure Subsystem: Reagent Pack Pack Invalid Corrupted or unprogrammed consumable idenitification tag Pack Expired Pack Empty No Pack The shelf-life for the reagent pack is past its expiration date. The in-service life for the reagent pack is past its expiration date Need to align the verbiage for this expiration date nomenclature with the Reagent IFU and customer IFU. The reagent pack is empty Reagent pack not installed Failure of the recognition component of the reagent pack Usage Update Fail Failing RFID module Failed/corrupt consumable Corrective Action Customer 1. Restart the system. 2. Replace the reagent pack. Refer to IFU procedure. If the problem persists, contact us. 3. Customer 1. Contact us. Customer 1. Replace the reagent pack. Refer to IFU procedure. If the problem persists, contact us. 2. Customer 1. Replace the reagent pack. Refer to IFU procedure. Customer 1. Replace the reagent pack. Refer to IFU procedure. Customer 1. Install the reagent pack. Refer to IFU procedure. If the problem persists, contact us. 2. Restart the system. 3. Customer 1. Replace the reagent pack. Refer to IFU procedure. 2. Restart the system. 3. If the problem persists, contact us. D-4 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Troubleshooting Table D Troubleshooting Table D.4 Troubleshooting Table - Motion Problem Subsystem: General Subsystem: Sample Deck Not Calibrated Calibration Failure Subsystem: Motor Operation Timeout Homing Failure Positioning Failure Probable Cause Corrective Action Stage/Controller replaced Software update failed to retain previous settings Corrupt settings Failed to correctly follow the calibration sequence Calibration resulted in invalid values Possible logic error Customer 1. Contact us. Customer 1. Contact us. Motor failed to execute operation in the allowed time Motor may be stalled or broken Main board may have a failing component The system may not have found homing flag within the allowed time Sensor failure Encoder failure The system did not reach the requested position. Encoder failure Motor failure Main board failure Motion obstructed Customer 1. Power cycle the system by unplugging the Analyzer and plugging it back in. 2. Turn on the Analyzer. 3. If the problem persists, contact us. Customer 1. Power cycle the system by unplugging the Analyzer and plugging it back in. If the problem persists, contact us. 2. Turn on the Analyzer. 3. Customer 1. Power cycle the system by unplugging the Analyzer and plugging it back in. 2. Turn on the Analyzer. 3. If the problem persists, contact us. PN C13232AA7 FINAL D-5 Draft Labeling Subject to Technical Review Troubleshooting Troubleshooting Table Table D.4 Troubleshooting Table - Motion Corrective Action Customer 1. Power cycle the system by unplugging the Analyzer. 2. Allow the system to cool down. 3. Plug the system back in. 4. Turn on the Analyzer. 5. If the problem persists, contact us. Customer 1. Power cycle the system by unplugging the Analyzer and plugging it back in. 2. Turn on the Analyzer. 3. If the problem persists, contact us. Problem Thermal Overcurrent Probable Cause The motor controller chip on board is overheating. Motor travel may be obstructed Motor wiring may be faulty Airflow through the instrument may be impeded The motor controller chip on board is overheating. Motor travel may be obstructed Motor wiring may be faulty Airflow through the instrument may be impeded Table D.5 Troubleshooting Table - Fluidics Problem Subsystem: General Hardware Error Communication Error Probable Cause Corrective Action Syringe pump failure Valve controller failure Customer 1. Power cycle the system by unplugging the Analyzer and plugging it back in. Communication fault with the syringe pump mechanism Possible failed pump Possible failed wiring connection Nightly Clean Cycle Skipped Possible main board failure Insufficient reagents present to execute the scheduled nightly clean Other hardware fault Subsystem: Syringe Pump If the problem persists, contact us. 2. Turn on the Analyzer. 3. Customer 1. Power cycle the system by unplugging the Analyzer and plugging it back in. 2. Turn on the Analyzer. 3. If the problem persists, contact us. Customer 1. Perform a manual clean. Refer to IFU procedure. 2. Check the reagent status. Refer to IFU procedure. 3. Retry the cleaning cycle at the next interval. Refer to IFU procedure. D-6 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Table D.5 Troubleshooting Table - Fluidics Problem
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Probable Cause
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Subsystem: Valve Controller
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Troubleshooting Table D Troubleshooting Corrective Action Customer 1. Power cycle the system by unplugging the Analyzer and plugging it back in. 2. Turn on the Analyzer. 3. If the problem persists, contact us. Customer 1. Power cycle the system by unplugging the Analyzer and plugging it back in. 2. Turn on the Analyzer. 3. If the problem persists, contact us. Table D.6 Troubleshooting Table - Imaging Problem Subsystem: General Hardware Error Probable Cause Corrective Action Camera is disconnected Camera failure Customer 1. Power cycle the system by unplugging the Analyzer and plugging it back in. Operation Timeout The camera failed to trigger Faulty camera connections Camera failure If the problem persists, contact us. 2. Turn on the Analyzer. 3. Customer 1. Power cycle the system by unplugging the Analyzer and plugging it back in. 2. Turn on the Analyzer. 3. If the problem persists, contact us. Subsystem: Camera Hardware Error Camera is disconnected Camera failure Customer 1. Power cycle the system by unplugging the Analyzer and plugging it back in. Operation Timeout The camera failed to trigger Faulty camera connections Camera failure Cannot connect
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Subsystem: Trigger If the problem persists, contact us. 2. Turn on the Analyzer. 3. Customer 1. Power cycle the system by unplugging the Analyzer and plugging it back in. If the problem persists, contact us. 2. Turn on the Analyzer. 3. Customer 1. Contact us. PN C13232AA7 FINAL D-7 Draft Labeling Subject to Technical Review Troubleshooting Troubleshooting Table Table D.6 Troubleshooting Table - Imaging Problem Hardware Error Probable Cause Problem with the main board Faulty main board to camera wiring Corrective Action Customer 1. Power cycle the system by unplugging the Analyzer and plugging it back in. Operation Timeout Problem with the main board Faulty main board to camera wiring Subsystem: LED Hardware Error Connection failure to LED module. If the problem persists, contact us. 2. Turn on the Analyzer. 3. Customer 1. Power cycle the system by unplugging the Analyzer and plugging it back in. 2. Turn on the Analyzer. 3. If the problem persists, contact us. Customer 1. Power cycle the system by unplugging the Analyzer and plugging it back in. 2. Turn on the Analyzer. 3. If the problem persists, contact us. D-8 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review APPENDIX E Replacing Reagents and Decontamination Reagent Status Select to display the Reagent Status screen. Replace Reagent Pack WARNING Risk of biohazardous exposure if you have skin contact with the Reagent Pack waste liquid. The Reagent Pack waste bottle has a vent and the Reagent Pack must be upright whenever you are handling a used Reagent Pack in order to prevent waste liquid from leaking out of the Reagent Pack waste bottle. Clean up spills immediately. Dispose of the Reagent Pack and the solid waste in accordance with your local regulations and acceptable laboratory procedures. Always use the appropriate Personal Protective Equipment (PPE) when working with biohazardous materials. PN C13232AA7 FINAL E-1 Draft Labeling Subject to Technical Review Replacing Reagents and Decontamination Reagent Status 1 Select and Replace Reagent Pack. 2 Select the reagent to drain and select
. E-2 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Replacing Reagents and Decontamination Reagent Status E 3 The reagent door opens. PN C13232AA7 FINAL E-3 Draft Labeling Subject to Technical Review
1 | C13232AA7 Part5 | Users Manual | 3.22 MiB | November 07 2018 / July 01 2019 |
Replacing Reagents and Decontamination Reagent Status WARNING Risk of biohazardous contamination if you have skin contact with the Reagent Pack and the solid waste container and its contents. The Reagent Pack and the solid waste container and its contents could contain residual biological material and must be handled with care. Clean up spills immediately. Dispose of the Reagent Pack and the solid waste in accordance with your local regulations and acceptable laboratory procedures. Always use the appropriate Personal Protective Equipment (PPE) when working with biohazardous materials. 4 Remove empty Reagent Pack LL BLU Inc. C06019 25C 15C Beckman Coulter, Inc. 250 S. Kraemer Blvd. Brea, CA 92821, U.S.A. www.beckmancoulter.com E-4 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Replacing Reagents and Decontamination Reagent Status E 5 Insert new Reagent Pack. Vi-CELL BLU Manufactured for Beckman Coulter, Inc. C06019 25C 15C Beckman Coulter, Inc. 250 S. Kraemer Blvd. Brea, CA 92821, U.S.A. www.beckmancoulter.com PN C13232AA7 FINAL E-5 Draft Labeling Subject to Technical Review Replacing Reagents and Decontamination Reagent Status 6 Close the reagent door and select
. 7 Confirm Reagent information and select
. E-6 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Replacing Reagents and Decontamination Reagent Status E WARNING Risk of biohazardous contamination if you have skin contact with the spent tube tray, its contents, and its associated tubing. The spent tube tray and its associated tubing could contain residual biological material and must be handled with care. Clean up spills immediately. Dispose of the contents of the spent tube tray in accordance with your local regulations and acceptable laboratory procedures. 8 Open the spent tube tray door. 9 Remove the spent tube tray. PN C13232AA7 FINAL E-7 Draft Labeling Subject to Technical Review Replacing Reagents and Decontamination Reagent Status 10 Empty the spent tube tray. 3232009AA 11 Select
. E-8 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Replacing Reagents and Decontamination Reagent Status E Prime the Instrument 1 Select and Prime. 2 When priming is complete, select to exit the screen. Decontaminate Green Screens need to be replaced throughout 1 Select and Decontaminate.Colin asks if we could recommend this be done weekly PN C13232AA7 FINAL E-9 Draft Labeling Subject to Technical Review Replacing Reagents and Decontamination Reagent Status WARNING Risk of chemical injury from bleach. To avoid contact with the bleach, use barrier protection, including protective eyewear, gloves, and suitable laboratory attire. Refer to the Safety Data Sheet for details about chemical exposure before using the chemical. 2 Prepare a bleach solution and select
. 3 Decontaminate the rest of the instrument and tap
. 4 The instrument will perform a flush cycle. E-10 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Replacing Reagents and Decontamination Reagent Status E 5 The instrument will Prime the fluid lines. Decontaminate with Vaporized Hydrogen Peroxide Beckman Coulter recognizes that you may need to occasionally decontaminate the instrument. The instrument is a high performance instrument with sensitive electronic, optical and mechanical components. Beckman Coulter has determined that the only approved method of decontamination for the instrument is to use Vaporized Hydrogen Peroxide (VHP). VHP decontamination is supported by the National Institutes of Health, is more personnel friendly than other methods, does not leave carcinogenic residue, and is accepted in countries around the world. CAUTION Methods that utilize any decontamination method other than Vaporized Hydrogen Peroxide (formaldehyde, etc.) are not supported by Beckman Coulter and could cause substantial damage to the instrument. This damage is not covered by the instrument warranty. WARNING Proper and successful application of a Vaporized Hydrogen Peroxide decontamination cycle is the responsibility of the Laboratory Safety Officer and the personnel performing the decontamination protocol. Only trained and certified personnel should perform decontamination activities. PN C13232AA7 FINAL E-11 Draft Labeling Subject to Technical Review Replacing Reagents and Decontamination Reagent Status CAUTION By their nature, decontamination methods are aggressive in order to kill pathogens. It is important that the following items be considered when the instrument is decontaminated:
VHP decontamination methods will cause slight and progressive aesthetic damage to items such as anodized aluminum, some paints and other coatings. Labels, including warning labels, may come loose and may need to be replaced after one or more decontamination cycles. Inspect the instrument after decontamination to determine if new labels should be applied. If additional labels are needed, contact your Beckman Coulter Representative. The serial and part number labels on the instrument may show degradation after the decontamination process. These values should be noted in your laboratory's device history documentation and/or other permanent records. Contact the manufacturer for replacement serial and part number labels if needed. Decontamination methods can be dangerous to those in the area; observe all safety rules presented by the decontamination provider. The application of VHP does not leave carcinogenic residue. Other, unsupported decontamination methods may. Do not allow the VHP decontamination cycle to condense. This could cause equipment damage that would not be covered under the warranty. Decontamination providers will develop a process cycle that should effectively decontaminate the instrument without condensing. A higher concentration decontamination cycle is shorter in duration, but very high concentrations run the risk of condensing. It is best to run lower concentrations in exchange for a longer decontamination cycle. Decontamination methods may not be effective against pathogens that are suspended in liquids. Liquids may be present due to leaks or spills and the instrument system must be inspected in order to assure that they are not present before a decontamination cycle is performed. The Laboratorys Safety Officer is the responsible for the choice, application and efficacy of any decontamination protocols. Any application notes or information from Beckman Coulter is for informational purposes only. The instrument has been designed to be tolerant of VHP decontamination;
however, an excessive number of applications may cause damage. Due to its sealed nature, the optical module of the Vi-CELL BLU does not receive sufficient concentrations of VHP to decontaminate it. Contact your Beckman Coulter Representative if you feel the optical module requires decontamination. E-12 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Replacing Reagents and Decontamination Reagent Status E CAUTION For the instrument to be sufficiently decontaminated, the following steps must be taken:
The Vi-CELL BLU Reagent Pack must be removed from the instrument and the regent bay door left open for the duration of the decontamination cycle. The waste tray must be removed from the instrument and the waste bay door left open for the duration of the decontamination cycle. The instrument must be powered down. PN C13232AA7 FINAL E-13 Draft Labeling Subject to Technical Review Replacing Reagents and Decontamination Reagent Status E-14 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Abbreviations IEEE Institute of Electrical and Electronics Engineers PN part number RoHS Restriction of Use of Hazardous Substances X times WEEE Waste Electrical and Electronic Equipment Directive PN C13232AA7 FINAL Abbreviations-1 Draft Labeling Subject to Technical Review Abbreviations Abbreviations-2 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Index installation environment validation, 2-3 what is a cell type, 6-1 Canadian Radio Interference, -ix cell types cell viability, A-1 Certification circularity statistics, C-1 cleaning and ventilation concentration specification, A-1 connecting the instrument, 2-6 contact information, Beckman Coulter control control concentration, B-2 control feature what is it, 7-1 what is the control feature, 7-1 controls for electronic records, 8-2 covers and panels warning, 3-1 Customer Support Center, ii run concentration control, 7-1 D daily startup, 3-1 daily verification, 2-22 data acquisition specifications, A-1 data analysis, 5-1 export results, 5-4 import results, 5-2 date and time, 2-16 decontaminate, E-9 disposal of electronic equipment, -xi using vaporized hydrogen peroxide, E-11 E effective field of view statistics, C-1 environment requirements, 2-1 environment validation (installation) ventilation and cleaning, 2-3 worktable, 2-2 error messages, D-1 Numerics 21 CFR Part 11, 8-1 electronic records rule, 8-1 electronic signatures rule, 8-1 FDA, 8-1 Section 11.3 Subpart A, 8-2 96 well plate add samples to the queue, 4-4 A abbreviations, Abbreviations-1 access levels users, 6-12 add 96 well plate samples to the queue, 4-4 add carousel samples to the queue, 4-1 analysis events sequence, 1-1 autofocus focusing wizard, B-1 B Beckman Coulter Customer Support Center, biohazard contamination warning, -xxiii, 4-1, bioprocess results, 4-12 contacting, ii 4-4 control concentration, B-2 C calibration call center, contact information, ii camera image options, 4-9 Canadian Radio Interference Certification, -ix carousel cautions cell count specification, A-1 cell type administration, 6-1 add samples to the queue, 4-1 definition, -v Index-1 Draft Labeling Subject to Technical Review Index establishing an electronic record, 8-3 21 CFR Part 11 Security, 8-3 applying electronic signatures, 8-5 electronic signature, 8-4 file history, 8-3 generating electronic signatures, 8-5 operational checks, 8-3 export results, 5-4 F FCC conformance FDA requirements, 8-2 first time login, 2-8 RFID, -x public docket No. 92S-0251., 8-2 G generating electronic signatures user account, 8-5 H help, Beckman Coulter Customer Support Center, ii hemacytometer home screen, 2-9 historical perspective, 1-3 signatures, 8-2 I implementing electronic records and import results, 5-2 install installation, 2-4 reagent pack, 2-11 environment, 2-1 power requirements, 2-1 pre-installation checks, 2-1 temperature and humidity requirements, 2-2 L language options, 2-16 login first time, 2-8 M main menu, 2-10 manual menu moving parts warning, -xii my profile conventions, xxi main menu, 2-10 user setup, 2-21 P parameters to display, 2-16 physical requirements, A-1 power requirements, 2-1 precautions other, xxiii safety, xxii setting up, 3-3 preferences prime instrument, E-9 Q quality control, 7-1 R reagent pack install, 2-11 reagent status, E-1 replace reagent pack, E-1 reports bioprocess reports, 6-7 cell type reports, 6-10 completed run summary reports, 6-4 instrument reports, 6-11 quality controls reports, 6-8 run results reports, 6-5 reports administration, 6-4 reviewing/reanalyze data, 5-1 RFID FCC conformance, -x RoHS caution label, -xiii RoHS notice, -xiii Run, 4-1 run a concentration control, 7-1 run options, 2-16 run results, 4-8 RoHS caution label, -xiii Index-2 Draft Labeling Subject to Technical Review run samples, 4-1, 4-4 run statistics, C-1 system settings, 2-16 system specifications, A-1 Index disposal of electronic equipment, -xi S Safety, v safety safety notice analysis events, 1-1 symbols, -xiv cleaning, xii electrical safety, viii maintenance, xiii safety symbols, xiv screen home screen, 2-9 Section 11.3 Subpart A, 8-2 security, 2-16 sequence Serial number, 2-16 service and maintenance, B-1 service, contact information, ii set focus, B-1 setup users, 2-19 signoff results, 4-14 software preferences, 3-3 specifications cell count, A-1 cell viability, A-1 concentration, A-1 data acquisition, A-1 physical requirement, A-1 system, A-1 unit dimensions, A-2 startup daily, 3-1 Statistics, C-1 Run Statistics, C-1 statistics, C-1 circularity, C-1 effective field of view, C-1 run statistics, C-1 storage administration, 6-11 support, Beckman Coulter customer, ii symbols system components, 1-5 system overview, 1-1 safety, -xiv T temperature and humidity requirements, 2-2 troubleshooting comm error, D-3 bootup error, D-3 update error, D-3 version, D-3 error, D-3 controller board, communication, host controller board, firmware, firmware controller board, firmware, firmware controller board, firmware, invalid firmware controller board, general, connection fluidics, general, communication error, D-6 fluidics, general, hardware error, D-6 fluidics, general, nightly clean skipped, D-6 fluidics, syringe pump, D-6 fluidics,valve controller, D-7 imaging, camera, cannot connect, D-7 imaging, camera, hardware error, D-7 imaging, camera, operation timeout, D-7 imaging, general, hardware error, D-7 imaging, general, operation timeout, D-7 imaging, LED, hardware error, D-8 imaging, trigger, hardware error, D-8 imaging, trigger, operation timeout, D-8 instrument, configuration, calibration not instrument, configuration, configuration instrument, database, insert error, D-2 instrument, database, no connection, D-2 instrument, database, retrieve error, D-2 instrument, general, logic error, D-1 instrument, general, missing instrument, integrity, verification on instrument, storage, near capacity, D-2 instrument, storage, read error, D-2 instrument, storage, write error, D-2 motion, general, D-5 motion, motor, homing failure, D-5 motion, motor, operation timeout, D-5 motion, motor, overcurrent, D-6 motion, motor, sample probe, positioning component, D-1 read, D-3 found, D-1 not found, D-1 Index-3 Draft Labeling Subject to Technical Review Index W warnings biohazard contamination, -xxiii, 4-1, 4-4 covers and panels, 3-1 definition, -v hazardous waste, -xxii moving parts, -xii installation environment validation, 2-2 worktable failure, D-5 motion, motor, thermal, D-6 motion, sample deck, calibration failure, D-5 motion, sample deck, not calibrated, D-5 reagents, bay hardware, latch error, D-4 reagents, bay hardware, sensor error, D-4 reagents, genera, D-3 reagents, reagent pack, no pack, D-4 reagents, reagent pack, pack empty, D-4 reagents, reagent pack, pack expired, D-4 reagents, reagent pack, pack invalid, D-4 reagents, reagent pack, usage update reagents, RFID hardware, hardware fail, D-4 error, D-3 troubleshooting tables, D-1 trypan blue dye exclusion method, 1-3 U unit dimensions, A-2 unpacking inspection, 2-5 user access levels, 6-12 user administration, 2-19 user setup, 2-19 user types, 6-12 my profile, 2-21 V vaporized hydrogen peroxide decontaminate, E-11 ventilation and cleaning installation environment validation, 2-3 verification daily, 2-22 instrument performance, 2-22 decontaminate, E-11 how to determine, 1-3 why measure, 1-3 measuring, 1-3 system components, 1-5 system overview, 1-1 image analysis solution, 1-3 viability and cellular parameters Vi-CELL BLU VHP viability Index-4 Draft Labeling Subject to Technical Review Beckman Coulter, Inc. Customer End User License Agreement This Product contains software that is owned by Beckman Coulter, Inc. or its suppliers and is protected by United States and international copyright laws and international trade provisions. You must treat the software contained in this Product like any other copyrighted material. This license and your right to use the Product terminate automatically if you violate any part of this agreement. This is a license agreement and not an agreement for sale. Beckman Coulter hereby licenses this Software to you under the following terms and conditions:
License This Software License authorizes the Customer to use the Licensed Program on a single personal computer. This software License and any of the licenses, programs or materials to which it applies may not be assigned, sublicensed or otherwise transferred by the Customer without prior written consent from Beckman Coulter. No right to print or copy, in whole or part, the Licensed Program is granted except as hereinafter expressly provided. IF YOU TRANSFER POSSESSION OF ANY COPY, MODIFICATION OR MERGED PORTION OF THE LICENSED PROGRAM TO ANOTHER PARTY, YOUR LICENSE IS AUTOMATICALLY TERMINATED. You May:
1. Use this software in the computer supplied to you by Beckman Coulter;
2. Maintain one copy of this software for backup purposes (the backup copy shall be supplied by Beckman 3. After written notification to Beckman Coulter, transfer the entire Product to another person or entity, Coulter);
provided you retain no copies of the Product software and the transferee agrees to the terms of this license agreement. You May Not:
1. Use, copy or transfer copies of this Software except as provided in this license agreement;
2. Alter, merge, modify or adapt this Software in any way including disassembling or decompiling;
3. Loan, rent, lease, or sublicense this Software or any copy. Permission To Copy Or Modify Licensed Programs:
Customers who wish to analyze data on an additional PC may make a second copy for this purpose. Limited Warranty Beckman Coulter warrants that the software will substantially conform to the published specifications for the Product in which it is contained, provided that it is used on the computer hardware and in the operating system environment for which it was designed. Should the media on which your software arrives prove defective, Beckman Coulter will replace said media free of charge within 90 days of delivery of the Product. This is your sole remedy for any breach of warranty for this software. Except as specifically noted above, Beckman Coulter makes no warranty or representation, either expressed or implied, with respect to this software or its documentation including quality, performance, merchantability, or fitness for a particular purpose. No Liability for Consequential Damages In no event shall Beckman Coulter or its suppliers be liable for any damages whatsoever (including, without limitation, damages for loss of profits, business interruption, loss of information, or other pecuniary loss) arising out of the use of or inability to use the Beckman Coulter Product software. Because some states do not allow the exclusion or limitation of liability for consequential damages, the above limitation might not apply to you. PN C13232AA7 FINAL Warranty-1 Draft Labeling Subject to Technical Review Beckman Coulter, Inc. Customer End User License Agreement License Agreement For Open Source Computer Vision Library (3-clause BSD License) General This agreement constitutes the entire agreement between you and Beckman Coulter and supersedes any prior agreement concerning this Product software. It shall not be modified except by written agreement dated subsequent to the date of this agreement signed by an authorized Beckman Coulter representative. Beckman Coulter is not bound by any provision of any purchase order, receipt, acceptance, confirmation, correspondence, or otherwise, unless Beckman Coulter specifically agrees to the provision in writing. This agreement is governed by the laws of the State of California. License Agreement For Open Source Computer Vision Library
(3-clause BSD License) By downloading, copying, installing or using the software you agree to this license. If you do not agree to this license, do not download, install, copy or use the software. Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met:
1. Redistributions of source code must retain the above copyright notice, this list of conditions and the 2. Redistributions in binary form must reproduce the above copyright notice, this list of conditions and the 3. Neither the names of the copyright holders nor the names of the contributors may be used to endorse or following disclaimer. following disclaimer in the documentation and/or other materials provided with the distribution. promote products derived from this software without specific prior written permission. This software is provided by the copyright holders and contributors "as is" and any express or implied warranties, including, but not limited to, the implied warranties of merchantability and fitness for a particular purpose are disclaimed. In no event shall copyright holders or contributors be liable for any direct, indirect, incidental, special, exemplary, or consequential damages (including, but not limited to, procurement of substitute goods or services; loss of use, data, or profits; or business interruption) however caused and on any theory of liability, whether in contract, strict liability, or tort (including negligence or otherwise) arising in any way out of the use of this software, even if advised of the possibility of such damage. Warranty-2 PN C13232AA7 FINAL Draft Labeling Subject to Technical Review Draft Labeling Subject to Technical Review Related Documents Introduction Introducing the Vi-CELL BLU Installation and Verification Vi-CELL BLU Cell Viability Analyzer, Instructions for Use PN C13232 Quick Start Guide Software Menus Special Software Features Exporting Results Regulatory Compliance - 21 CFR Part 11 Appendices References www.beckmancoulter.com 2018 Beckman Coulter, Inc. All Rights Reserved Draft Labeling Subject to Technical Review
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2018-07-11 | 13.56 ~ 13.56 | DXX - Part 15 Low Power Communication Device Transmitter | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2018-07-11
|
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1 | Applicant's complete, legal business name |
Beckman Coulter Inc.
|
||||
1 | FCC Registration Number (FRN) |
0027135581
|
||||
1 | Physical Address |
250 South Kraemer Blvd.
|
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1 |
Brea, California 92821
|
|||||
1 |
United States
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
c******@ccsemc.com
|
||||
1 | TCB Scope |
A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
2AOSQ
|
||||
1 | Equipment Product Code |
RFIDM2
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
B******** H******** W********
|
||||
1 | Title |
Staff Compliance Engineer
|
||||
1 | Telephone Number |
13172********
|
||||
1 | Fax Number |
13178********
|
||||
1 |
b******@beckman.com
|
|||||
app s | Technical Contact | |||||
1 | Firm Name |
Beckman Coulter, Inc.
|
||||
1 | Name |
S****** M****
|
||||
1 | Physical Address |
250 South Kraemer Blvd
|
||||
1 |
Brea, California 92821
|
|||||
1 |
United States
|
|||||
1 | Telephone Number |
970-7********
|
||||
1 |
S******@beckman.com
|
|||||
app s | Non Technical Contact | |||||
1 | Firm Name |
Beckman Coulter, Inc.
|
||||
1 | Name |
B******** W******
|
||||
1 | Physical Address |
250 South Kraemer Blvd
|
||||
1 |
Brea, 92821
|
|||||
1 |
United States
|
|||||
1 | Telephone Number |
(317)********
|
||||
1 |
b******@beckman.com
|
|||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 01/07/2019 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DXX - Part 15 Low Power Communication Device Transmitter | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Cell Analyzer | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
UL LLC
|
||||
1 | Name |
R******** T****
|
||||
1 | Telephone Number |
847-2********
|
||||
1 | Fax Number |
847-3********
|
||||
1 |
R******@us.ul.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
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Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 13.56000000 | 13.56000000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC