QIAsymphony SP -AS Consolidated Operating Guide ver 1.1 May 2013

Trademarks QIAGEN®, QIAsymphony ®, Rotor-Gene®, Rotor-Disc® (QIAGEN Group); DECON-QUAT® (Veltek Associates, Inc.); DNA-ExitusPlus™ (Applichem GmbH); Gigasept®, Mikrozid® (Schülke & Mayr GmbH); Incidin® (Ecolab, Inc.); LightCycler® (Roche Group); Sarstedt® (Sarstedt AG and Co.). Registered names, trademarks, etc. used in this document, even when not specifically marked as such, are not to be considered unprotected by law. © 2012–2013 QIAGEN, all rights reserved.

Contents

Contents 1

Safety Information

1-1

1.1

Proper use

1-2

1.2

Electrical safety

1-3

1.3 Environment 1.3.1 Operating conditions

1-4 1-4

1.4 Biological safety 1.4.1 Samples

1-4 1-5

1.5

Chemicals

1-6

1.6

Mechanical hazards

1-7

1.7

Heat hazard

1-7

1.8

Maintenance safety

1-8

1.9

Waste disposal

1-9

1.10 Symbols on the QIAsymphony SP/AS instruments

1-10

2

Introduction

2-1

2.1 General information 2.1.1 Technical assistance 2.1.2 Policy statement

2-1 2-1 2-2

2.2 Intended use 2.2.1 QIAsymphony SP 2.2.2 QIAsymphony AS

2-2 2-2 2-2

2.3 Requirements for QIAsymphony SP/AS users 2.3.1 Training for QIAsymphony SP/AS users

2-3 2-3

2.4

QIAsymphony Cabinet SP/AS

2-4

2.5

User manual references

2-4

2.6

Icon used throughout this consolidated operating guide

2-4

2.7

Glossary

2-5

QIAsymphony SP/AS Consolidated Operating Guide 05/2013 Contents-1

Contents 2.8

QIAsymphony SP/AS accessories

2-5

3

Startup Procedure

3-1

3.1 Site requirements 3.1.1 Workbench

3-1 3-1

3.2 General features 3.2.1 Hood(s) 3.2.2 Touchscreen 3.2.3 USB ports 3.2.4 Network interface 3.2.5 Status LEDs 3.2.6 Switching on the QIAsymphony SP/AS 3.2.7 Logging out 3.2.8 Switching off the QIAsymphony SP/AS

3-2 3-2 3-2 3-3 3-3 3-3 3-4 3-5 3-6

4

User Settings

4-1

4.1

Configuration settings

4-1

4.2 User accounts 4.2.1 Create new users 4.2.2 Activate/inactivate user accounts 4.2.3 System request for password change 4.2.4 User request for password change

4-1 4-2 4-4 4-5 4-7

5

5-1

QIAsymphony SP/AS User Interface

5.1 QIAsymphony SP/AS screen layout 5.1.1 Status bar 5.1.2 “Tab” menus

5-1 5-1 5-5

5.2

Software symbols

5-6

6

Handling Files

6-1

6.1

Transfer options

6-1

6.2

Data transfer via the USB stick

6-2

Contents-2 QIAsymphony SP/AS Consolidated Operating Guide 05/2013

Contents 6.3

File transfer from QIAsymphony instruments to the USB stick

6-2

6.4

Transferring files from the USB stick

6-5

6.5 Synchronizing files 6-6 6.5.1 Synchronizing files on QIAsymphony SP/AS instruments with files on the USB stick 6-6 6.5.2 Synchronizing files on the USB stick with files on the QIAsymphony SP/AS 6-8 6.6

Deleting files

6-9

7

QIAsymphony SP Features

7-1

7.1 Workflow principle 7.1.1 Basic principle

7-2 7-2

7.2 Instrument features 7.2.1 Magnetic head 7.2.2 Lysis station 7.2.3 Robotic arm

7-3 7-3 7-4 7-4

7.3 Bar code reader 7.3.1 Sample input bar code reader 7.3.2 Reagents and consumables 2D bar code reader 7.3.3 Bar code types 7.3.4 Handheld scanner

7-6 7-6 7-7 7-7 7-7

8

Loading QIAsymphony SP Drawers

8-1

8.1

Using the software Wizard

8-1

8.2 Loading the “Waste” drawer 8.2.1 Tip park station 8.2.2 Liquid waste container 8.2.3 Tip chute 8.2.4 Tip waste collection 8.2.5 Unit boxes 8.2.6 Closing the “Waste” drawer

8-2 8-4 8-4 8-5 8-5 8-5 8-7

8.3

8-7

Loading the “Eluate” drawer

QIAsymphony SP/AS Consolidated Operating Guide 05/2013 Contents-3

Contents 8.3.1 8.3.2 8.3.3 8.3.4

Features of the “Eluate” drawer Loading procedure Transfer module Unloading the “Eluate” drawer

8-7 8-9 8-12 8-13

8.4 Loading the “Reagents and Consumables” drawer 8.4.1 Loading consumables 8.4.2 Reagent cartridges 8.4.3 Buffer bottle 8.4.4 Accessory Trough 8.4.5 Unloading reagents and consumables

8-16 8-16 8-20 8-22 8-23 8-24

8.5 Loading the “Sample” drawer 8.5.1 Loading tube carriers 8.5.2 Loading the plate carrier

8-25 8-26 8-35

8.6 Performing inventory scans (SP) 8.6.1 Inventory scan of the “Reagents and Consumables” drawer 8.6.2 Inventory scan of the “Waste” drawer 8.6.3 Inventory scan of the “Eluate” drawer

8-36

8.7 Starting, pausing, resuming, and stopping a run 8.7.1 Starting a run 8.7.2 Pausing a run 8.7.3 Resuming a run 8.7.4 Stopping a run

8-40 8-40 8-40 8-40 8-40

8.8

End of batch processing or run

8-41

8.9

End of working day

8-41

9

QIAsymphony SP Run Definitions

9-1

9.1

Configuring a sample type

9-1

9.2

Use of virtual bar codes

9-2

9.3 Defining a batch/run (queuing) 9.3.1 Samples loaded in the tube carrier

8-36 8-39 8-39

9-2 9-2

Contents-4 QIAsymphony SP/AS Consolidated Operating Guide 05/2013

Contents 10

QIAsymphony AS Features

10-1

10.1 QIAsymphony AS principle

10-1

10.2 Instrument features 10.2.1 QIAsymphony AS hood 10.2.2 QIAsymphony status LEDs 10.2.3 Robotic arm

10-3 10-3 10-4 10-4

11

QIAsymphony AS Drawers

11-1

11.1 “Eluate and Reagents” drawer 11.1.1 Filter-tips

11-1 11-2

11.2 “Assays” drawer

11-2

12

12-1

QIAsymphony AS Basic Functions

12.1 Definitions 12.1.1 Independent operation 12.1.2 Integrated operation 12.1.3 Run with normalization 12.1.4 Standard curve

12-1 12-1 12-2 12-2 12-3

12.2 Preparing a run 12.2.1 Assay favorites

12-3 12-3

12.3 Integrated run 12.3.1 Defining an integrated run 12.3.2 Loading an integrated run 12.3.3 Checking cooling temperatures 12.3.4 Starting an integrated run 12.3.5 Removing assays after an AS run 12.3.6 Procedure after run completion 12.3.7 Pausing, resuming, and stopping an integrated run

12-5 12-7 12-18 12-33 12-35 12-35 12-36 12-37

12.4 Independent run 12.4.1 Defining an independent assay run 12.4.2 Defining/checking sample rack(s) 12.4.3 Defining assay(s) to be processed in the run

12-39 12-39 12-44 12-50

QIAsymphony SP/AS Consolidated Operating Guide 05/2013 Contents-5

Contents 12.4.4 Assigning selected assays to sample positions 12-53 12.4.5 Modifying assay parameters 12-57 12.4.6 Queuing an independent assay run 12-59 12.4.7 Validating the assay run 12-60 12.4.8 Loading an independent run 12-60 12.4.9 Checking cooling temperatures 12-62 12.4.10 Starting an independent run 12-62 12.4.11 Removing assays after an independent run 12-63 12.4.12 Pausing, resuming, and stopping an independent run 12-69 12.5 Performing inventory scans (AS) 12.5.1 Inventory scan of “Eluate and Reagents” drawer 12.5.2 Inventory scan of the “Assays” drawer 12.5.3 Transfer to a PCR cycler

12-71 12-71 12-73 12-73

13

13-1

Troubleshooting

13.1 Error messages and warnings 13.1.1 Errors indicated in the status bar 13.1.2 Errors indicated in the tab headers 13.1.3 Errors indicated in the command bar 13.1.4 Messages with “Help” button 13.1.5 Messages without “Help” button

13-1 13-1 13-1 13-2 13-2 13-3

13.2 Software help boxes 13.2.1 Structure of software help boxes

13-4 13-5

13.3 Contacting QIAGEN Technical Services 13.3.1 Make a record of the incident 13.3.2 Creating an instrument report file

13-6 13-6 13-7

13.4 Error codes

13-8

13.5 General errors that do not have error codes 13.5.1 File handling errors 13.5.2 File errors 13.5.3 Tip waste errors 13.5.4 Maintenance errors 13.5.5 “Configuration” menu errors

13-28 13-29 13-30 13-37 13-38 13-38

Contents-6 QIAsymphony SP/AS Consolidated Operating Guide 05/2013

Contents 13.6 QIAsymphony SP errors that do not have error codes 13.6.1 “Eluate” drawer 13.6.2 “Sample” drawer 13.6.3 “Waste” drawer 13.6.4 “Reagents and Consumables” drawer 13.6.5 Errors that may occur when starting a batch/run 13.6.6 Protocol errors 13.6.7 Errors that may occur while operating the QIAsymphony SP 13.6.8 Protocol interruption 13.6.9 Inventory scan errors

13-39 13-39 13-41 13-43 13-44 13-44 13-45 13-46 13-47 13-48

13.7 QIAsymphony AS errors that do not have error codes 13-51 13.7.1 Assay definition errors 13-51 13.7.2 Inventory scan errors 13-53 13.7.3 Errors occurring during an assay run 13-54 13.7.4 Data analysis errors 13-56 13.8 Integrated run errors that do not have error codes 13.8.1 “Eluate” drawer 13.8.2 Removal of an integrated run 13.8.3 Maintenance, service, and configuration

13-59 13-59 13-60 13-60

14

14-1

Maintenance

14.1 Cleaning

14-1

14.2 Servicing

14-3

14.3 Regular maintenance 14.3.1 Regular disposal of tips 14.3.2 Regular maintenance procedure for the QIAsymphony SP 14.3.3 Regular maintenance procedure for the QIAsymphony AS

14-4 14-4

14.4 Daily maintenance (SP/AS) 14.4.1 Pipetting system tip guards (SP/AS) 14.4.2 Tip disposal chute

14-6 14-6 14-7

14-4 14-5

QIAsymphony SP/AS Consolidated Operating Guide 05/2013 Contents-7

Contents 14.4.3 14.4.4 14.4.5 14.4.6 14.4.7

Drawers and lysis station (SP) Drawers (AS) Conveyor base tray (SP) - optional Robotic gripper (SP) Liquid waste container (SP)

14-8 14-8 14-9 14-9 14-9

14.5 Weekly maintenance (SP/AS) 14.5.1 File management 14.5.2 Cleaning the touchscreen 14.5.3 Cleaning the QIAsymphony SP/AS hoods 14.5.4 Cleaning the tube carriers (SP) 14.5.5 Cleaning the optical sensor (SP) 14.5.6 Magnetic head (SP) 14.5.7 Liquid waste container (SP) 14.5.8 Cleaning adapters (AS)

14-9 14-9 14-10 14-10 14-10 14-10 14-10 14-11 14-11

14.6 UV decontamination of the worktable

14-12

14.7 Maintenance of the tip adapter O-ring 14.7.1 Checking the O-ring for wear and tear 14.7.2 Using the “O-Ring Change Tool Set” to perform O-ring change

14-14 14-14

15

Technical Data

15-1

15.1 Environmental conditions

15-1

15.2 Mechanical data and hardware features

15-2

16

16-1

User Interface Addendum

14-16

Appendix A

A-1

Declaration of conformity

A-1

Waste Electrical and Electronic Equipment (WEEE)

A-3

FCC declaration

A-4

Liability clause

A-5

Contents-8 QIAsymphony SP/AS Consolidated Operating Guide 05/2013

Contents Index

Index-1

QIAsymphony SP/AS Consolidated Operating Guide 05/2013 Contents-9

Contents Page left intentionally blank

Contents-10 QIAsymphony SP/AS Consolidated Operating Guide 05/2013

Safety Information

1

Safety Information This consolidated operating guide contains information about warnings and cautions that must be followed by the user to ensure safe operation of the QIAsymphony SP/AS instruments and to maintain the instruments in a safe condition. Possible hazards that could harm the user or result in damage to the instrument are clearly stated at the appropriate places throughout this consolidated operating guide. If the equipment is used in a manner not specified by the manufacturer, the protection provided by the equipment may be impaired. The following safety conventions are used throughout this consolidated operating guide.

WARNING

The term WARNING is used to inform you about situations that could result in personal injury to you or other persons.

CAUTION

The term CAUTION is used to inform you about situations that could result in damage to the instrument or other equipment. The advice given in this consolidated operating guide is intended to supplement, not supersede, the normal safety requirements prevailing in the user’s country.

QIAsymphony SP/AS Consolidated Operating Guide 05/2013

1-1

Safety Information

1.1

Proper use

WARNING/ CAUTION

Risk of personal injury and material damage Improper use of the QIAsymphony SP/AS may cause personal injuries or damage to the instrument. The QIAsymphony SP/AS must only be operated by qualified personnel who have been appropriately trained. Servicing of the QIAsymphony SP/AS must only be performed by QIAGEN Field Service Specialists.

CAUTION

Damage to the instrument Avoid spilling water or chemicals onto the QIAsymphony SP/AS. Instrument damage caused by water or chemical spillage will void your warranty. Do not place items on top of the QIAsymphony SP/AS hoods.

CAUTION

Damage to the instrument Do not lean on the touchscreen when it is folded down.

In case of emergency, switch off the QIAsymphony SP/AS instruments and unplug the power cord from the power outlet.

1-2

QIAsymphony SP/AS Consolidated Operating Guide 05/2013

Safety Information

1.2

Electrical safety If operation of the instruments is interrupted in any way (e.g., due to interruption of the power supply or a mechanical error), first switch off the QIAsymphony SP/AS instruments, then disconnect the electrical cord from the power supply and contact QIAGEN Technical Services.

WARNING

Electrical hazard Any interruption of the protective conductor (earth/ground lead) inside or outside the instrument or disconnection of the protective conductor terminal is likely to make the instrument dangerous. Intentional interruption is prohibited. Lethal voltages inside the instrument When the instrument is connected to line power, terminals may be live. Opening covers or removing parts is likely to expose live parts. When working with the QIAsymphony SP/AS instruments:  The line power cord must be connected to a line power outlet that has a protective conductor (earth/ground).  Do not adjust or replace internal parts of the instruments.  Do not operate the instruments with any covers or parts removed.  If liquid has spilled inside the instruments, switch off the instruments, disconnect them from the power outlet, and contact QIAGEN Technical Services. If the QIAsymphony SP/AS becomes electrically unsafe, prevent other personnel from operating them, and contact QIAGEN Technical Services. The instruments may be electrically unsafe when:  The QIAsymphony SP/AS or the line power cord appears to be damaged.  The QIAsymphony SP/AS has been stored under unfavorable conditions for a prolonged period.  The QIAsymphony SP/AS has been subjected to severe transport stresses.

QIAsymphony SP/AS Consolidated Operating Guide 05/2013

1-3

Safety Information  Liquids have come into direct contact with electrical components of the QIAsymphony SP/AS.

1.3

Environment

1.3.1

Operating conditions

WARNING

Explosive atmosphere The QIAsymphony SP/AS is not designed for use in an explosive atmosphere.

WARNING

Risk of overheating To ensure proper ventilation, maintain a minimum clearance of 5 cm (1.97 in.) at the rear of the QIAsymphony SP/AS. Slits and openings that ensure the ventilation of the QIAsymphony SP/AS must not be covered.

1.4

Biological safety Specimens and reagents containing materials from humans should be treated as potentially infectious. Use safe laboratory procedures as outlined in publications such as Biosafety in Microbiological and Biomedical Laboratories, HHS (www.cdc.gov/od/ohs/biosfty/biosfty.htm).

1-4

QIAsymphony SP/AS Consolidated Operating Guide 05/2013

Safety Information

1.4.1 WARNING

Samples Samples containing infectious agents Some samples used with this instrument may contain infectious agents. Handle such samples with the greatest of care and in accordance with the required safety regulations. Always wear safety glasses, gloves, and a lab coat. The responsible persons (e.g., laboratory manager) must take the necessary precautions to ensure that the surrounding workplace is safe, and that the instrument operators are suitably trained and not exposed to hazardous levels of infectious agents as defined in the applicable Safety Data Sheets (SDSs) or OSHA,* ACGIH,† or COSHH‡ documents. Venting for fumes and disposal of wastes must be in accordance with all national, state, and local health and safety regulations and laws.

* OSHA: Occupational Safety and Health Administration (United States of America). †

ACGIH: American Conference of Government Industrial Hygienists (United States of America).

‡

COSHH: Control of Substances Hazardous to Health (United Kingdom).

Samples may contain infectious agents. You should be aware of the health hazard presented by such agents and should use, store, and dispose of such samples in accordance with the required safety regulations.

QIAsymphony SP/AS Consolidated Operating Guide 05/2013

1-5

Safety Information

1.5

Chemicals

WARNING

Hazardous chemicals Some chemicals used with the QIAsymphony SP/AS instruments may be hazardous or may become hazardous after completion of the protocol run. Always wear safety glasses, gloves, and a lab coat. The responsible persons (e.g., laboratory manager) must take the necessary precautions to ensure that the surrounding workplace is safe and that the instrument operators are not exposed to hazardous levels of toxic substances (chemical or biological) as defined in the applicable Safety Data Sheets (SDSs) or OSHA,* ACGIH,† or COSHH‡ documents. Venting for fumes and disposal of wastes must be in accordance with all national, state, and local health and safety regulations and laws.

* OSHA: Occupational Safety and Health Administration (United States of America). †

ACGIH: American Conference of Government Industrial Hygienists (United States of America).

‡

COSHH: Control of Substances Hazardous to Health (United Kingdom).

Toxic fumes If you work with volatile solvents, toxic substances, etc., you must provide an efficient laboratory ventilation system to remove vapors that may be produced. WARNING

Toxic fumes Do not use bleach to clean or disinfect QIAsymphony SP/AS instruments. Bleach in contact with salts from the buffers can produce toxic fumes.

WARNING

Toxic fumes Do not use bleach to disinfect used labware. Bleach in contact with salts from the buffers used can produce toxic fumes.

1-6

QIAsymphony SP/AS Consolidated Operating Guide 05/2013

Safety Information

1.6

Mechanical hazards The hoods of the QIAsymphony SP/AS instruments must remain closed during operation. Only open the hoods when instructed to do so by the software.

WARNING

Moving parts To avoid contact with moving parts during operation of QIAsymphony SP/AS instruments, the instruments must be operated with the hoods closed. If the hood sensors are not functioning correctly, contact QIAGEN Technical Services.

WARNING

Strong magnetic field Do not place QIAsymphony SP/AS instruments near magnetic storage systems (e.g., computer discs). Do not use metal tools when handling the magnetic rods. Do not allow the magnetic rods to come into contact with other magnets.

CAUTION

Damage to the instrument(s) Make sure to install the magnetic-head guards before operating the QIAsymphony SP.

1.7

Heat hazard The QIAsymphony SP supports a lysis station that can be heated, if required by the protocol. In addition, both the QIAsymphony SP and the QIAsymphony AS support a UV lamp.

WARNING

Hot surface The lysis station and the UV lamps can reach temperatures of up to 70°C (158°F). Avoid touching them during operation.

QIAsymphony SP/AS Consolidated Operating Guide 05/2013

1-7

Safety Information

1.8

Maintenance safety

WARNING/ CAUTION

Risk of personal injury and material damage Only perform maintenance as described in this consolidated operating guide.

Perform the maintenance as described in Section 14. QIAGEN charges for repairs that are required due to incorrect maintenance. WARNING/ CAUTION

Risk of personal injury and material damage Improper use of QIAsymphony SP/AS instruments may cause personal injuries or damage to the instruments. QIAsymphony SP/AS instruments must only be operated by qualified personnel who have been appropriately trained. Servicing of QIAsymphony SP/AS instruments must only be performed by QIAGEN Field Service Specialists.

WARNING

Risk of fire When cleaning QIAsymphony SP/AS instruments with alcohol-based disinfectant, leave the instrument hoods open to allow flammable vapors to disperse. Only clean QIAsymphony SP/AS instruments with alcoholbased disinfectant when worktable components have cooled down.

CAUTION

Damage to the instrument(s) Do not use bleach, solvents, or reagents containing acids, alkalis, or abrasives to clean QIAsymphony SP/AS instruments.

CAUTION

Damage to the instrument(s) Do not use spray bottles containing alcohol or disinfectant to clean surfaces of the QIAsymphony SP/AS instruments. Spray bottles should be used only to clean items that have been removed from the worktables.

1-8

QIAsymphony SP/AS Consolidated Operating Guide 05/2013