QIAsymphony SP - AS User Manual - General Description ver 3.1 May 2013

Trademarks QIAGEN®, QIAsymphony ®, artus®, Rotor-Gene®, Rotor-Disc® (QIAGEN Group); DECON-QUAT® (Veltek Associates, Inc.); DNA-ExitusPlus™ (Applichem GmbH); Microsoft®, Excel® (Microsoft Corporation); LightCycler® (Roche Group); Gigasept®, Mikrozid® (Schülke & Mayr GmbH); Incidin® (Ecolab, Inc.); 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. 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

1-2

1.3

Environment

1-4

1.4

Biological safety

1-4

1.5

Chemicals

1-6

1.6

Mechanical hazards

1-7

1.7

Magnetic hazard

1-7

1.8

Heat hazard

1-7

1.9

Maintenance safety

1-8

1.10 Symbols on the QIAsymphony SP/AS instruments

1-11

2

Introduction

2-1

2.1

Provided user documents

2-1

2.2 General information 2.2.1 Technical assistance 2.2.2 Policy statement 2.2.3 Version management

2-2 2-2 2-3 2-3

2.3

2-3

Intended use of the QIAsymphony SP

2.4 Intended use of the QIAsymphony AS 2.4.1 Requirements for QIAsymphony SP/AS users 2.4.2 Training for QIAsymphony SP/AS users

2-4 2-4 2-5

3

General Description

3-1

3.1 QIAsymphony SP 3.1.1 QIAsymphony SP principle

3-1 3-2

3.2

3-4

External features of the QIAsymphony SP

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Contents-1

Contents 3.3 QIAsymphony SP drawers 3.3.1 “Sample” drawer 3.3.2 “Reagents and Consumables” drawer 3.3.3 Inventory scan of “Reagents and Consumables” drawer 3.3.4 “Waste” drawer 3.3.5 Inventory scan of the “Waste” drawer 3.3.6 “Eluate” drawer 3.3.7 Inventory scan of the “Eluate” drawer

3-7 3-8 3-12

3.4 Internal features of the QIAsymphony SP 3.4.1 Lysis station 3.4.2 Robotic arm 3.4.3 Magnetic head

3-23 3-23 3-23 3-25

3.5 QIAsymphony AS 3.5.1 QIAsymphony AS principle

3-26 3-28

3.6

3-29

External features of the QIAsymphony AS

3-18 3-21 3-21 3-21 3-23

3.7 QIAsymphony AS drawers 3.7.1 “Eluate and Reagents” drawer 3.7.2 Inventory scan of “Eluate and Reagents” drawer 3.7.3 “Assays” drawer 3.7.4 Inventory scan of “Assays” drawer

3-31 3-31 3-32 3-34 3-35

3.8 Internal features of the QIAsymphony AS 3.8.1 Robotic arm 3.8.2 Transfer module 3.8.3 Transfer frame

3-35 3-35 3-35 3-36

4

Installation Procedures

4-1

4.1

Instrument delivery and installation

4-1

4.2

Requirements

4-1

4.3

AC power connection

4-2

Contents-2

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Contents 5

General Operation

5-1

5.1

Switching on the QIAsymphony SP/AS instruments

5-1

5.2

Getting Started

5-3

5.3

Logging in

5-4

5.4 Logging out 5.4.1 Active logout 5.4.2 Automatic logout

5-6 5-6 5-7

5.5

Switching off the QIAsymphony SP/AS instruments

5-7

6

Configuration

6-1

6.1 Configuring the QIAsymphony SP/AS instruments 6.1.1 Date and time 6.1.2 Default tube types 6.1.3 Adapters and holders (QIAsymphony AS only) 6.1.4 System settings

6-3 6-3 6-4 6-6 6-7

6.2 Process settings 6.2.1 Changing the software configuration 6.2.2 Changing individual configuration parameters

6-11 6-11 6-13

6.3 Using process configuration profiles 6.3.1 Creating a custom process configuration profile 6.3.2 Modifying a process configuration profile 6.3.3 Removing a custom profile 6.3.4 Handling saved process configuration profiles

6-24 6-24 6-25 6-27 6-27

7

Managing Users

7-1

7.1

Create new users

7-2

7.2

Activate/inactivate user accounts

7-5

7.3

Change of user role

7-6

7.4

Change of password by the “Supervisor”

7-7

7.5 Change of password by “Operator” 7.5.1 Automatic request of new password

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7-8 7-8

Contents-3

Contents 7.5.2

User request for password change (“Operator” role) 7-10

8

Handling Files

8-1

8.1

Summary QIAsymphony SP/AS files

8-4

8.2

Using a USB stick with the QIAsymphony SP/AS instruments8-8

8.3 Data transfer via the USB stick 8-9 8.3.1 Setting up the USB stick 8-9 8.3.2 Transferring files from the QIAsymphony SP/AS to the USB stick 8-11 8.3.3 Transferring files from the USB stick to the QIAsymphony SP/AS instruments 8-16 8.4 Synchronization of files 8-18 8.4.1 Synchronizing files on the QIAsymphony SP/AS instruments with files on the USB stick 8-19 8.4.2 Synchronization of files on the USB stick with files on the QIAsymphony SP/AS 8-20 8.5 Deleting files 8-22 8.5.1 Deleting input and output files from the QIAsymphony SP/AS 8-22 8.5.2 Deleting other files 8-24 8.6

Process configuration profile

8-26

8.7

Start batch confirmation file

8-26

8.8

QIAsymphony SP result file

8-27

8.9

QIAsymphony AS result file

8-35

8.10 Loading information file

8-52

8.11 Work list files

8-56

8.12 Rack file

8-62

8.13 Cycler files

8-65

8.14 Instrument report file

8-67

8.15 Log files

8-67

8.16 Concentration data file

8-67

Contents-4

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Contents 9

Maintenance

9-1

9.1 Regular maintenance procedure 9-5 9.1.1 Regular maintenance procedure for the QIAsymphony SP9-5 9.1.2 Regular maintenance procedure for the QIAsymphony AS9-7 9.2 Daily maintenance procedure 9-7 9.2.1 Daily maintenance procedure for the QIAsymphony SP 9-8 9.2.2 Daily maintenance procedure for the QIAsymphony AS9-11 9.3 Weekly maintenance procedure 9-13 9.3.1 Weekly maintenance procedure for the QIAsymphony SP9-14 9.3.2 Weekly maintenance procedure for the QIAsymphony AS9-16 9.4

UV decontamination of the worktable

9-16

9.5 Maintenance of the tip adapter O-ring 9.5.1 Checking the O-ring for wear and tear 9.5.2 O-ring change procedure

9-19 9-19 9-21

9.6

Mounting the tip disposal bag

9-22

10

Troubleshooting

10-1

10.1 Error messages and warnings 10.1.1 Errors indicated in the status bar 10.1.2 Errors indicated in the tab headers 10.1.3 Errors indicated in the command bar 10.1.4 Messages with “Help” button 10.1.5 Messages without “Help” button

10-1 10-1 10-1 10-2 10-2 10-3

10.2 Software help boxes 10.2.1 Structure of software help boxes

10-4 10-5

10.3 Contacting QIAGEN Technical Services 10.3.1 Make a record of the incident 10.3.2 Creating an instrument report file

10-6 10-6 10-7

10.4 Error codes

10-9

10.5 General errors that do not have error codes 10.5.1 File handling errors 10.5.2 File errors

10-28 10-29 10-30

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Contents-5

Contents 10.5.3 10.5.4 10.5.5

Tip waste errors Maintenance errors “Configuration” menu errors

10-36 10-37 10-37

10.6 QIAsymphony SP errors that do not have error codes 10-38 10.6.1 “Eluate” drawer 10-38 10.6.2 “Sample” drawer 10-40 10.6.3 “Waste” drawer 10-42 10.6.4 “Reagents and Consumables” drawer 10-43 10.6.5 Errors that may occur when starting a batch/run 10-43 10.6.6 Protocol errors 10-44 10.6.7 Errors that may occur while operating the QIAsymphony SP 10-45 10.6.8 Protocol interruption 10-46 10.6.9 Inventory scan errors 10-47 10.7 QIAsymphony AS errors that do not have error codes 10.7.1 Assay definition errors 10.7.2 Inventory scan errors 10.7.3 Errors occurring during an assay run 10.7.4 Data analysis errors

10-50 10-50 10-51 10-53 10-55

10.8 Integrated run errors that do not have error codes 10.8.1 “Eluate” drawer 10.8.2 Removal of an integrated run 10.8.3 Maintenance, service, and configuration

10-57 10-57 10-58 10-58

11

11-1

Glossary

Appendix A

A-1

Technical data

A-1

Environmental conditions

A-1

Mechanical data and hardware features

A-2

Bar code labels

A-3

Open source software

A-4

Contents-6

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Contents Waste Electrical and Electronic Equipment (WEEE)

A-6

FCC declaration

A-7

Declaration of Conformity - QIAsymphony SP

A-8

Declaration of Conformity - QIAsymphony AS

A-9

Appendix B

B-1

Liability Clause

B-1

Appendix C

C-1

QIAsymphony SP/AS accessories

C-1

Index

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Index-1

Contents-7

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Contents-8

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Safety Information

1

Safety Information Before using the QIAsymphony SP/AS instruments, it is essential that you read this user manual carefully and pay particular attention to the safety information. The instructions and safety information in the user manual must be followed to ensure safe operation of the instruments and to maintain the instruments in a safe condition. The following types of safety information appear throughout the QIAsymphony SP/AS User Manuals.

WARNING

The term WARNING is used to inform you about situations that could result in personal injury to you or other persons. Details about these circumstances are given in a box like this one.

CAUTION

The term CAUTION is used to inform you about situations that could result in damage to the instruments or other equipment. Details about these circumstances are given in a box like this one. The advice given in this manual is intended to supplement, not supersede, the normal safety requirements prevailing in the user’s country.

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1-1

Safety Information

1.1

Proper use

WARNING/ CAUTION

Risk of personal injury and material damage [W1] Improper use of the QIAsymphony SP/AS instruments may cause personal injuries or damage to the instruments. The QIAsymphony SP/AS instruments must only be operated by qualified personnel who have been appropriately trained. Servicing of the QIAsymphony SP/AS instruments must only be performed by QIAGEN Field Service Specialists. Note: Do not place items on top of the QIAsymphony SP/AS hoods. Perform the maintenance as described in Section 9. QIAGEN charges for repairs that are required due to incorrect maintenance.

CAUTION

Damage to the instrument(s) [C1] Avoid spilling water or chemicals onto the QIAsymphony SP/AS instruments. Damage caused by water or chemical spillage will void your warranty. In case of emergency, switch off the QIAsymphony SP/AS instruments at the power switch at the front of the QIAsymphony SP and unplug the power cord from the power outlet.

CAUTION

1.2

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

[C2]

Electrical safety Note: 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 instruments using the power switch, then disconnect the electrical cord from the power supply and contact QIAGEN Technical Services.

1-2

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Safety Information WARNING

Electrical hazard [W2] Any interruption of the protective conductor (earth/ground lead) inside or outside the instruments or disconnection of the protective conductor terminal is likely to make the instrument dangerous. Intentional interruption is prohibited. Lethal voltages inside the instruments When the instruments are connected to line power, terminals may be live. Opening covers or removing parts is likely to expose live parts. To ensure satisfactory and safe operation of the QIAsymphony SP/AS instruments, follow the advice below:  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 instruments become electrically unsafe, prevent other personnel from operating them, and contact QIAGEN Technical Services; the instruments may be electrically unsafe when:  The instruments or the line power cord appear to be damaged.  The instruments have been stored under unfavorable conditions for a prolonged period.  The instruments have been subjected to severe transport stresses.  Liquids have come into direct contact with electrical components of the QIAsymphony SP/AS instruments.

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1-3

Safety Information

1.3

Environment Operating conditions

WARNING

Explosive atmosphere [W3] The QIAsymphony SP/AS instruments are 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 instruments. Slits and openings that ensure the ventilation of the QIAsymphony SP/AS instruments must not be covered.

1.4

[W4]

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).

Samples 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 according to the required safety regulations.

1-4

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Safety Information WARNING

Samples containing infectious agents [W5] Some samples used with the QIAsymphony SP/AS instruments may contain infectious agents. Handle such samples with care and in accordance with the required safety regulations. The responsible persons (e.g., laboratory manager) must take the necessary precautions to ensure that the 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).

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1-5

Safety Information

1.5 WARNING

Chemicals Hazardous chemicals [W6] 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 person (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 working with volatile solvents or toxic substances, you must provide an efficient laboratory ventilation system to remove vapors that may be produced. WARNING

Toxic fumes [W7] Do not use bleach to clean or disinfect the QIAsymphony SP/AS instruments. Bleach in contact with salts from the buffers can produce toxic fumes.

WARNING

Toxic fumes [W8] Do not use bleach to disinfect used labware. Bleach in contact with salts from the buffers used can produce toxic fumes.

1-6

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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

1.7

Moving parts [W9] To avoid contact with moving parts during operation of the 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.

Magnetic hazard The QIAsymphony SP uses magnetic rods for processing magnetic particles. These magnetic rods generate a strong magnetic field.

WARNING

Strong magnetic field Persons with metal prostheses should not operate the QIAsymphony SP/AS instruments. Prostheses may be damaged by close contact with the instrument.

CAUTION

Strong magnetic field [C3] Do not place the 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.

1.8

[W10]

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.

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1-7

Safety Information WARNING

Hot surface [W11] The lysis station and the UV lamps can reach temperatures of up to 70°C (158°F). Avoid touching them during operation.

1.9

Maintenance safety

WARNING/ CAUTION

Risk of personal injury and material damage [W12] Only perform maintenance that is specifically described in this user manual.

WARNING/ CAUTION

Risk of personal injury and material damage [W13] Improper use of the QIAsymphony SP/AS instruments may cause personal injuries or damage to the instruments. The QIAsymphony SP/AS instruments 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(s) [C4] Do not use bleach, solvents, or reagents containing acids, alkalis, or abrasives to clean the QIAsymphony SP/AS instruments.

CAUTION

Damage to the instrument(s) [C5] 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

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Safety Information CAUTION

Damage to the instrument(s) [C6] After wiping the drawers and lysis station with paper towels, make sure that no bits of paper towel remain. Pieces of paper towel remaining on the worktable could lead to a worktable collision.

CAUTION

Damage to the instrument hood(s) or side panels [C7] Never clean the instrument hood(s) or side panels with alcohol or alcohol-based solutions. Alcohol will damage the hood and the side panels. To clean the hood(s) and side panels, use distilled water.

WARNING

Risk of electric shock [W14] Do not open any panels on the QIAsymphony SP/AS instruments. Risk of personal injury and material damage Only perform maintenance that is specifically described in this user manual.

WARNING

Risk of fire [W15] When cleaning the QIAsymphony SP/AS instruments with alcohol-based disinfectant, leave the instrument hoods open to allow flammable vapors to disperse. Only clean the QIAsymphony SP/AS instruments with alcohol-based disinfectant when worktable components have cooled down.

CAUTION

Damage to the instrument(s) [C8] Make sure to install the tip guards before operating the QIAsymphony SP/AS instruments.

CAUTION

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

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[C9]

1-9

Safety Information CAUTION

Damage to the instrument(s) [C10] Make sure not to damage the cables and the electronic board when wiping the magnetic head.

Waste disposal Used consumables, such as sample tubes, sample prep cartridges, 8-Rod Covers, disposable filter-tips, reagent tubes, and elution racks, may contain hazardous chemicals or infectious agents from the purification or assay setup process. Such wastes must be collected and disposed of properly according to local safety regulations. For disposal of waste electrical and electronic equipment (WEEE), see page A-4. WARNING

1-10

Hazardous chemicals and infectious agents [W16] The waste contains samples and reagents. This waste may contain toxic or infectious material and must be disposed of properly. Refer to your local safety regulations for proper disposal procedures.

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