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100
| Chapter 4: Maintenance and Performance Verification (IQ/OQ/PQ)
Recommended Performance Verification Schedule
TASK
System Self-Test, p. 125
Checksum Test, p. 125
8-, 8s- 12-Channel Manifolds:
Evacuation Efficiency Test, p. 127
Dispense Precision Test, p. 128
16-Channel Manifold:
Evacuation Efficiency Test, p. 131
Dispense Precision Test, p. 132
Aspiration Carrier (ELx50/8FMW):
Evacuation Efficiency Test, p. 134
Installation
Qualification
Operational
Qualification
Initially &
Annually
Performance
Qualification
Monthly
It is important to note that the risk and performance factors associated with your assays may require that some or all of the procedures be performed more frequently than presented in the schedule.
BioTek Instruments, Inc.
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Table of contents
- 4 Notices
- 5 Contents
- 10 Contact Information
- 11 Document Conventions
- 12 Revision History
- 15 Intended Use Statement
- 15 Quality Control
- 15 Repackaging and Shipping
- 15 Warnings
- 16 Hazards and Precautions
- 18 Directives
- 19 Electromagnetic Interference and Susceptibility
- 19 User Safety
- 20 Safety Symbols
- 24 Introducing the ELx50 Microplate Strip Washer
- 25 ELx50 Washer Variations
- 25 Manifold Variations
- 27 Carrier Variations
- 27 Software Variations
- 29 Hardware Features
- 30 Accessories Included
- 31 Optional Accessories
- 32 Specifications
- 32 Microplates
- 32 Electrical
- 32 Physical
- 32 Hardware
- 33 Performance Specifications
- 34 Product Support & Service
- 34 Contacting the Technical Assistance Center
- 34 Returning Instruments for Service/Repair
- 36 Unpacking and Inspecting the Instrument
- 42 Setting Up the ELx50
- 42 Operating Environment
- 42 Installing the Carrier and Manifold
- 42 Microplate Carrier
- 43 8-, 8s-, or 12-Channel Manifold
- 44 16-Channel Manifold
- 45 Aspiration Carrier (ELx50™/8FMW)
- 47 Connecting the Tubes and Bottles
- 47 Before Connecting the Tubes and Bottles
- 50 Waste System
- 53 Supply System
- 56 Liquid Level Alert™ Option
- 57 Final Check
- 57 Attaching the Mist Shield
- 58 Connecting the Power Supply and Cord
- 58 Serial Port for Communication With Other Devices
- 59 Verifying Performance
- 60 Repackaging and Shipping
- 60 Before Repackaging the Instrument
- 61 Repackaging the ELx50 and Its Accessories
- 74 ELx50 Front Panel
- 75 Keypad Description
- 76 Entering Program Names
- 76 System Startup
- 78 Main Menu
- 79 General Usage Guidelines
- 78 Before Running Any Program
- 80 Maintenance
- 80 Programming Considerations
- 81 Liquid Level Alert™ Option
- 83 Wash
- 82 Run Wash Program
- 83 Define Wash Program
- 83 Define Wash Program Options
- 84 Define Wash METHOD Program Options
- 86 Define Wash DISPENSE (DISP) Program Options
- 89 Define Wash ASPIRATION (ASPIR) Program Options
- 93 Edit Wash Program
- 93 Copy Wash Program
- 93 Delete Wash Program
- 96 Prime
- 94 Define Prime Program
- 96 Run Prime Program
- 96 Edit Prime Program
- 97 Copy Prime Program
- 97 Delete Prime Program
- 100 Dispense
- 98 Define Dispense Program
- 98 Run Dispense Program
- 99 Edit Dispense Program
- 99 Copy Dispense Program
- 100 Delete Dispense Program
- 103 Aspiration
- 101 Define Aspiration Program
- 102 Run Aspiration Program
- 103 Edit Aspiration Program
- 103 Copy Aspiration Program
- 104 Delete Aspiration Program
- 107 Soak
- 105 Define Soak Program
- 106 Edit Soak Program
- 106 Copy Soak Program
- 107 Delete Soak Program
- 110 Linking Programs
- 108 Define Link Program
- 109 View Link Program
- 109 Run Link Program
- 110 Delete Link Program
- 113 Utility
- 111 Tests
- 111 Self-Test (SLFCHK)
- 111 Configuration Information (CHKSUM)
- 112 Setup
- 112 Manifold (MANIFLD)
- 112 SENSOR
- 113 AutoPrime
- 116 Menu Maps
- 120 Overview
- 121 Recommended Maintenance Schedule
- 122 Recommended Performance Verification Schedule
- 123 Warnings & Precautions
- 124 Maintenance Programs
- 125 Prime Programs
- 126 Daily Maintenance
- 126 DAY_RINSE
- 126 AUTOPRIME
- 127 AutoPrime Program Options
- 128 Overnight Maintenance
- 128 OVERNIGHT_LOOP
- 129 RINSE_AND_SOAK
- 130 Monthly Maintenance
- 130 Tools and Supplies
- 131 Cleaning the Bottles
- 131 Cleaning the Manifold
- 132 Cleaning the Aspirate and Dispense Tubes
- 132 8-, 8s-, or 12-Channel Manifold:
- 132 16-Channel Manifold:
- 133 Cleaning the Carrier
- 133 Microplate Carrier
- 134 Aspiration Carrier (ELx50™/8FMW only)
- 136 Cleaning the Check Valves
- 137 Long-Term Storage Maintenance
- 137 LONG_SHUTDOWN
- 138 Disinfect the Aspiration Carrier (ELx50™/8FMW)
- 138 Storing the ELx50™
- 139 Decontamination
- 139 Purpose
- 140 Tools and Supplies
- 141 Decontamination Procedure for External Components
- 141 Decontamination Procedure for Tubing and Manifold
- 142 Alternate Decontamination Procedure for Tubing and Manifold
- 142 Decontamination Procedure for Aspiration Carrier (ELx50/8FMW)
- 144 Performance Verification
- 145 Installation Qualification (IQ)
- 145 Operational Qualification (OQ)
- 146 Performance Qualification (PQ)
- 147 Self-Test and Checksum Test
- 148 Liquid Tests for the 8-, 8s- and 12-Channel Manifolds
- 148 Evacuation Efficiency and Dispense Precision Tests
- 148 Materials
- 149 Evacuation Efficiency Test Procedure
- 150 Dispense Precision Test Procedure
- 151 Liquid Tests Worksheet (8-, 8s-, and 12-Channel Manifolds)
- 152 Liquid Tests for the 16-Channel Manifold
- 152 Evacuation Efficiency and Dispense Precision Tests
- 152 Materials
- 153 Evacuation Efficiency Test Procedure
- 154 Dispense Precision Test Procedure
- 155 Liquid Tests Worksheet (16-Channel Manifold)
- 156 Liquid Test for the Aspiration Carrier (ELx50/8FMW)
- 156 Evacuation Efficiency Test
- 156 Materials
- 156 Evacuation Efficiency Test Procedure
- 158 Liquid Test Worksheet (Aspiration Carrier)
- 159 Maintenance/Performance and Operational Logs
- 164 Overview
- 164 Troubleshooting Checklist
- 165 Troubleshooting Charts
- 165 Washer Start-Up
- 166 Fluid Aspiration
- 170 Fluid Delivery
- 172 Fluid Leakage
- 173 Carrier Movement
- 173 Washer Manifold Movement
- 174 Microplate Scratches
- 174 Syringe Drive Movement