C311 Training Curriculum (General)

System Description:
• Hardware Overview and Instrument Specification
o Overview of the cobas c 311 analyzer
o Basic Specifications and Unique Functionality of the instrument
o Principle of action
▪ Photometric
▪ Potentiometric (ISE)
o Main Components
o ISE component
o Cobas Link
• Software Overview and Description
o System Overview Screen and User Interface
o Workplace Menu
o Reagent Menu
o Calibration Menu
o Quality Control Menu
o Utility Menu
o System statuses and operational workflow

Safe operation of the analyzer

• Operation and Handling
o Preparing the Analyzer
o Starting the Analyzer
• Instrument Modes
o Operation mode
o Maintenance mode
• Safety Labels
• Workflow Guide
Concepts
• Reagent Concept
o Reagents for ISE applications
o Reagents for photometric applications
o Cobas C packs
o Barcode label
o Handling of reagents
o Reagent Registration, loading and Unloading
o Package inserts
• Calibration Concept
o General information about calibrators
o Triggers for automatic calibration requests
o Calibration rules for the photometric unit
o ISE calibration concept
o Lot and cassette calibrations for the photometric unit
o General calibration rules and Calibration Stability
o Calibration quality criteria for photometric tests
o Calibration Cause and overview
• Quality Control Concept
o General information about controls
o QC methods
▪ Individual and cumulative QC
▪ Realtime QC
o System implementations for QC measurements
o Control stability
o Priorities of control target value and cut-offs
▪ L-J Chart Review
▪ Westgard Rules

Troubleshooting
• Introduction to Troubleshooting
• Data Alarms
o ISE Unit
o Photometric Unit
Maintenance
• Maintenance items
• Maintenance log

Laboratory Exercises
 C311 Training Curriculum (BAsic)

System Description:
• Introduction to Hardware Overview and Instrument Specification
o Overview of the cobas c 311 analyzer
o Basic Specifications and Unique Functionality of the instrument
o Principle of action
▪ Photometric
▪ Potentiometric (ISE)
o Main Components
o ISE component
o Cobas Link
• Introduction to Software Overview and Description
o System Overview Screen and User Interface
o Workplace Menu
o Reagent Menu
o Calibration Menu
o Quality Control Menu
o Utility Menu
o System statuses and operational workflow

Safe operation of the analyzer

• Operation and Handling
o Preparing the Analyzer
o Starting the Analyzer
• Instrument Modes
o Operation mode
o Maintenance mode
• Safety Labels
• Workflow Guide
Concepts
• Reagent Concept
o Reagents for ISE applications
o Reagents for photometric applications
o Cobas C packs
o Barcode label
o Handling of reagents
o Reagent Registration, loading and Unloading
o Package inserts
• Basic Calibration Concept
o General information about calibrators
o ISE calibration concept
o Lot and cassette calibrations for the photometric unit
• Basic Quality Control Concept
o General information about controls
o Control stability
o Priorities of control target value and cut-offs
▪ L-J Chart Review
▪ Westgard Rules

Basic Troubleshooting
• Introduction to Troubleshooting
• Data alarms

Maintenance
• Maintenance items
• Maintenance log

Laboratory Exercises
 C311 Training Curriculum (Advanced)

Challenges during Instrument Handling

• Alarms, issues, and reoccurring challenges during Instrument Handling

Test Menu Review

• Site specific Assay Menu review

• Test menu Expansion needs

Advanced System Description:

• Review of Hardware Overview and Instrument Specification
o Main Components
o ISE component
o Cobas Link Update
• Review of Software Overview and Description
o Calibration status and Result Menu
o Utility Menu
o System statuses and operational workflow

Advanced Concepts
• Review of Reagent Concept
o Package inserts (Elabdoc)
o Errors associated with poor reagent Handling
o Data transfer media
• Review of Calibration Concept
o General calibration rules and Calibration Stability
o Calibration quality criteria
o Calibration Cause and overview
• Advanced Quality Control Concept
o Control types and relevancy to tests
o Control stability
o Priorities of control target value and cut-offs
Advanced Troubleshooting
• Data Alarms
• Alarm resolution and trend analysis
Maintenance Review and challenges encountered

Laboratory Exercises