GE ReadyToProcess WAVE 25 Operating Instructions Manual

ReadyToProcess WAVE

™

25

Operating Instructions

Original instructions

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Table of Contents

51 Introduction ..........................................................................................................

61.1 About this manual ................................................................................................................................

71.2 Important user information .............................................................................................................

91.3 Regulatory information ......................................................................................................................

101.3.1 EU Directives ....................................................................................................................................

111.3.2 Eurasian Customs Union ............................................................................................................

121.3.3 Regulations for USA and Canada ...........................................................................................

131.3.4 Other regulations and standards ............................................................................................

151.4 Important concepts .............................................................................................................................

161.5 User documentation ...........................................................................................................................

172 Safety instructions ...............................................................................................

182.1 Safety precautions ...............................................................................................................................

262.2 Labels .........................................................................................................................................................

272.2.1 Instrument labels ...........................................................................................................................

312.2.2 Safety labels .....................................................................................................................................

332.2.3 Additional labels .............................................................................................................................

352.3 Emergency procedures ......................................................................................................................

382.4 Recycling information .........................................................................................................................

392.5 Declaration of Hazardous Substances (DoHS) ........................................................................

413 System description ..............................................................................................

423.1 System overview ...................................................................................................................................

443.2 ReadyToProcess WAVE 25 rocker .................................................................................................

523.3 ReadyToProcess CBCU .......................................................................................................................

553.4 ReadyToProcess Pump 25 ................................................................................................................

583.5 Cellbag bioreactor ................................................................................................................................

613.6 UNICORN software overview ..........................................................................................................

623.6.1 General UNICORN operation .....................................................................................................

653.6.2 Administration .................................................................................................................................

663.6.3 System control ................................................................................................................................

723.6.4 Evaluation .........................................................................................................................................

734 Installation ............................................................................................................

744.1 Site preparation .....................................................................................................................................

754.1.1 Delivery and storage ....................................................................................................................

764.1.2 Site requirements ...........................................................................................................................

814.1.3 Client computer specifications .................................................................................................

834.2 Hardware installation .........................................................................................................................

844.2.1 Unpack the system units ............................................................................................................

864.2.2 Connect the system components ...........................................................................................

904.3 Software installation ...........................................................................................................................

914.3.1 Install UNICORN software ..........................................................................................................

944.3.2 Configure an e-license .................................................................................................................

1014.3.3 Define the system ..........................................................................................................................

ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 3

Table of Contents

1035 Operation ..............................................................................................................

1045.1 Set up the system .................................................................................................................................

1055.1.1 Select the tray and Cellbag bioreactor .................................................................................

1065.1.2 Attach and detach tray ................................................................................................................

1095.1.3 Prepare pH and DO sensors ......................................................................................................

1125.1.4 Attach the Cellbag bioreactor ...................................................................................................

1145.1.5 Prepare the pump ..........................................................................................................................

1195.1.6 Connect gas to the system ........................................................................................................

1235.2 Start and configure the system .....................................................................................................

1245.2.1 Start the system and log on to UNICORN ...........................................................................

1255.2.2 Connect to the system .................................................................................................................

1275.2.3 Configure system properties .....................................................................................................

1295.2.4 Configure system settings ..........................................................................................................

1315.2.5 Start a run .........................................................................................................................................

1355.3 Prepare for cultivation ........................................................................................................................

1365.3.1 Inflate the Cellbag bioreactor ...................................................................................................

1375.3.2 Adjust pump parameters ...........................................................................................................

1385.3.3 Add and equilibrate culture medium .....................................................................................

1415.3.4 Prepare the sensors ......................................................................................................................

1445.4 Perform cultivation ..............................................................................................................................

1455.4.1 Inoculate the culture .....................................................................................................................

1465.4.2 Monitor the run ...............................................................................................................................

1485.4.3 End a run ...........................................................................................................................................

1506 Maintenance .........................................................................................................

1516.1 Calibration ................................................................................................................................................

1536.2 Cleaning ....................................................................................................................................................

1546.3 Cleaning before planned service ...................................................................................................

1557 Troubleshooting ...................................................................................................

1567.1 ReadyToProcess WAVE 25 system ................................................................................................

1577.2 ReadyToProcess WAVE 25 rocker .................................................................................................

1617.3 ReadyToProcess CBCU .......................................................................................................................

1627.4 ReadyToProcess Pump 25 ................................................................................................................

1637.5 UNICORN System Control .................................................................................................................

1658 Reference information ........................................................................................

1668.1 Chemical resistance ............................................................................................................................

1678.2 Health and Safety Declaration Form ...........................................................................................

169Index .......................................................................................................................

4 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD

Table of Contents

1 Introduction

About this chapter

This chapter contains important user information, the intended use of ReadyToProcess

WAVE 25, description of safety notices, and regulatory information.

In this chapter

This chapter contains the following sections:

See pageSection

61.1 About this manual

71.2 Important user information

91.3 Regulatory information

151.4 Important concepts

161.5 User documentation

ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 5

1 Introduction

1.1 About this manual

Purpose of this manual

The Operating Instructions provide you with the information needed to install, operate

and maintain the product in a safe way.

Scope of this document

This manual covers the entire ReadyToProcess WAVE 25 system, including the main unit

(rocker), CBCU and pump, as well as accessories.

Typographical conventions

Software items are identified in the text by bold italic text. A colon separates menu levels,

thus File:Open refers to the Open command in the File menu.

Hardware controls, indicators and connections are identified in the text by bold text (for

example, Power switch).

Text entries that UNICORN™ generates or that the user must type are represented by a

monospaced typeface (forexample, \Program Files\GE Healthcare\UNICORN\).

6 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD

1 Introduction

1.1 About this manual

1.2 Important user information

Read the Operating Instructions

before operating the product

All users must read the entire separate Operating Instructions before installing, op-

erating, or maintaining the product.

Always keep the Operating Instructions at hand when operating the product.

Do not operate the product in any other way than described in the user documentation.

If you do, you may be exposed to hazards that can lead to personal injury and you may

cause damage to the equipment.

Intended use

The ReadyToProcess WAVE 25 system is intended to be used as laboratory and manu-

facturing equipment for cell cultivation. The system may not be used for clinical or diag-

nostic purposes.

Prerequisites

In order to follow this manual and use the system in the intended manner, it is important

that:

•

you have a general understanding of how the client computer and Microsoft

®

Win-

dows

®

operating systems work.

•

you are acquainted with the use of general laboratory equipment and with handling

of biological materials.

•

you have read and understood the Safety instructions chapter in these Operating

Instructions.

•

the system is installed according to the instructions in these Operating Instructions.

•

a user account has been created according to UNICORN Administration and Technical

manual.

ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 7

1 Introduction

1.2 Important user information

Safety notices

This user documentation contains safety notices (WARNING, CAUTION, and NOTICE)

concerning the safe use of the product. See definitions below.

WARNING

WARNING indicates a hazardous situation which, if not avoided,

could result in death or serious injury. It is important not to proceed

until all stated conditions are met and clearly understood.

CAUTION

CAUTION indicates a hazardous situation which, if not avoided,

could result in minor or moderate injury. It is important not to pro-

ceed until all stated conditions are met and clearly understood.

NOTICE

NOTICE indicates instructions that must be followed to avoid

damage to the product or other equipment.

Notes and tips

A note is used to indicate information that is important for trouble-free and

optimal use of the product.

Note:

A tip contains useful information that can improve or optimize your procedures.

Tip:

8 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD

1 Introduction

1.2 Important user information

1.3 Regulatory information

Introduction

This section lists the regulations and standards that apply to ReadyToProcess WAVE 25.

Manufacturing information

The table below summarizes the required manufacturing information.

InformationRequirement

GE Healthcare Bio-Sciences AB,Name and address of manufacturer

Björkgatan 30, SE 751 84 Uppsala, Sweden

In this section

See pageSection

101.3.1 EU Directives

111.3.2 Eurasian Customs Union

121.3.3 Regulations for USA and Canada

131.3.4 Other regulations and standards

ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 9

1 Introduction

1.3 Regulatory information

1.3.1 EU Directives

Conformity with EU Directives

This product fulfills the European Directives listed below. See the EU Declaration of

Conformity for the directives and regulations that apply for the CE marking.

If not included with the product, a copy of the EU Declaration of Conformity is available

on request.

TitleDirective

Machinery Directive (MD)2006/42/EC

Electromagnetic Compatibility (EMC) Directive2014/30/EU

Low Voltage Directive (LVD)2014/35/EU

Restriction of Hazardous Substances (RoHS) Directive2011/65/EU

CE marking

The CE marking and the corresponding EU Declaration of Conformity is valid for the in-

strument when it is:

•

used according to the Operating Instructions or user manuals, and

•

used in the same state as it was delivered from GE, except for alterations described

in the Operating Instructions or user manuals.

10 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD

1 Introduction

1.3 Regulatory information

1.3.1 EU Directives

1.3.2 Eurasian Customs Union

Introduction

This section contains additional regulatory information to comply with the Eurasian

Customs Union technical regulations.

Manufacturer and importer

information

The table below summarizes the manufacturer and importer information required by

the Eurasian Customs Union.

InformationRequirement

See Manufacturing informationName and address of manufacturer

Telephone: + 46 771 400 600Telephone number of manufacturer

GE Healthcare LLCImporter and/or company for obtain-

ing information about importer

GE Healthcare Life Sciences

Presnenskaya nab., 10C, 12th floor

RU-123 317 Moscow, Russian Federation

Telephone 1: + 7 495 411 9714

Fax nr: + 7 495 739 6932

Email: [email protected]

ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 11

1 Introduction

1.3 Regulatory information

1.3.2 Eurasian Customs Union

1.3.3 Regulations for USA and Canada

NRTL certification

This symbol indicates that Ready to Process bioreactor has been certified by Intertek,

which is a US Occupational Safety and Health Administration Nationally Recognized

Testing Laboratory (NRTL).

This product Conforms to UL 61010-1, and is Certified to CAN/CSA-C22.2 No. 61010-1.

CAN ICES/NMB compliance

This product complies with the Canadian standard ICES-001/NMB-001 concerning

electromagnetic compatibility.

FCC compliance

This device complies with part 15 of the FCC Rules. Operation is subject to the following

two conditions: (1) This device may not cause harmful interference, and (2) this device

must accept any interference received, including interference that may cause undesired

operation.

The user is cautioned that any changes or modifications not expressly approved

by GE could void the user’s authority to operate the equipment.

Note:

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 rea-

sonable protection against harmful interference when the equipment is operated in a

commercial environment. This equipment generates, uses, and can radiate radio frequen-

cy 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 re-

quired to correct the interference at his own expense.

12 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD

1 Introduction

1.3 Regulatory information

1.3.3 Regulations for USA and Canada

1.3.4 Other regulations and standards

Environmental conformity

This product conforms to the following environmental requirements.

TitleRequirement

Management Methods for the Restriction of the Use of Haz-

ardous Substances in Electrical and Electronic Products.

China RoHS

Standards, machinery and

electrical equipment

Standard requirements fulfilled by this product are summarized in the table below.

DescriptionStandard

Safety of machinery. General principles for design. Risk

assessment and risk reduction.

EN ISO 12100

Safety requirements for electrical equipment for mea-

surement, control, and laboratory use - Part 1: General

requirements.

EN 61010-1, IEC 61010-1,

UL 61010-1, CAN/CSA-

C22.2 No. 61010-1

Particular requirements for laboratory equipment for

the heating of materials

IEC/EN 61010-2-010

Electrical Equipment for Measurement, Control, and

Laboratory Use-EMC requirements-Part 1: General re-

quirements

EN 61326-1

(Emission according to CISPR 11, Group 1, class A)

NOTICE

This equipment is not intended for

use in residential environments

and may not provide adequate

protection to radio reception in

such environments.

Industrial, Scientific and Medical (ISM) Radio Frequency

Generators (Canada)

ICES-001/NMB-001

ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 13

1 Introduction

1.3 Regulatory information

1.3.4 Other regulations and standards

Software declaration of

conformity

UNICORN 6.3, 7.0 and later versions are technically compatible with all relevant sections

of FDA 21 CFR Part 11.

A part 11-system assessment checklist is available on request from your local GE repre-

sentative.

14 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD

1 Introduction

1.3 Regulatory information

1.3.4 Other regulations and standards

1.4 Important concepts

Concepts and abbreviations used in this manual are explained in the table below.

ExplanationConcept/

abbreviation

The disposable container in which the cells are cul-

tured.

Cellbag™ bioreactor

Dissolved oxygen.DO

Optical sensor for measurement of dissolved oxygen.

Attached to DO configured Cellbag bioreactors.

DO sensor

Operating mode with one Cellbag bioreactor on the

rocker.

Single mode

Operating mode with two Cellbag bioreactors on the

same rocker. Cultivation is monitored and controlled

independently in the two bioreactors.

Dual mode

Optical sensor for pH measurement. Attached to pH

configured Cellbag bioreactors.

pH sensor

Control unit for gas mix, pH and DO control.ReadyToProcess™ CBCU

The pump.ReadyToProcess Pump 25

The rocker.ReadyToProcess WAVE 25

rocker

Tray for Cellbag, mounted on the rocker. Different

tray sizes are available for different culture capacities.

Tray

The entire bioreactor system, including rocker,

CBCU(s), and pump(s), together with Cellbag bioreac-

tor(s) and filter heater(s).

ReadyToProcess WAVE 25

The ReadyToProcess WAVE

25 system

The bioreactor system

The software used for controlling and monitoring the

system.

UNICORN

ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 15

1 Introduction

1.4 Important concepts

1.5 User documentation

The table below describes the user documentation for ReadyToProcess WAVE 25, which

is available from the Help menu in UNICORN or on the user documentation CD.

Main contentsDocument

Instructions needed to install, operate and maintain

ReadyToProcess WAVE 25 in a safe way. Includes

basic UNICORN 7.0 system control functions.

ReadyToProcess WAVE 25

Operating instructions

Detailed system descriptions and instructions on

how to run, maintain and troubleshoot

ReadyToProcess WAVE 25. Includes UNICORN 7.0

system control functions, method creation and

handling, together with evaluation and presentation

of data.

ReadyToProcess WAVE 25

System Handbook

Brief instructions providing an overview of how to

run the system.

ReadyToProcess WAVE 25 Cue

Card

Overview and detailed description of network setup

and complete software installation. Administration

of UNICORN and the UNICORN database.

UNICORN Administration and

Technical manual

Dialog descriptions for UNICORN 7.0.UNICORN Online Help

CD containing the listed manuals and translated

versions of ReadyToProcess WAVE 25 Operating

instructions.

User Documentation CD

16 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD

1 Introduction

1.5 User documentation

2 Safety instructions

About this chapter

This chapter describes safety precautions, labels and symbols that are attached to the

equipment. In addition, the chapter describes emergency shutdown procedures, and

provides recycling information.

Important

WARNING

Before installing, operating or maintaining the product, all users

must read and understand the entire contents of this chapter

to become aware of the hazards involved.

In this chapter

This chapter contains the following sections:

See pageSection

182.1 Safety precautions

262.2 Labels

352.3 Emergency procedures

382.4 Recycling information

392.5 Declaration of Hazardous Substances (DoHS)

ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 17

2 Safety instructions

2.1 Safety precautions

Introduction

ReadyToProcess WAVE 25 is powered by mains voltage and handles materials that may

be hazardous. Before installing, operating or maintaining the system, you must be aware

of the hazards described in this manual.

Follow the instructions provided to avoid personal injuries, damage to the cell cul-

tures, to the product, or to other personnel and equipment in the area.

The safety precautions in this section are grouped into the following categories:

•

General precautions

•

Flammable liquids and explosive environment

•

Personal protection

•

Installing and moving the equipment

•

Power supply

•

System operation

•

Maintenance

Some of the safety precautions in this chapter concern situations that are described in

other manuals.

General precautions

WARNING

Do not operate the product in any other way than described in the

user documentation.

WARNING

Only properly trained personnel may operate and maintain the

product.

WARNING

Do not use any accessories not supplied or recommended by GE.

18 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD

2 Safety instructions

2.1 Safety precautions

WARNING

Do not use ReadyToProcess WAVE 25 if it is not working properly,

or if it has suffered any damage, for example:

•

damage to the power cord or its plug

•

damage caused by dropping the equipment

•

damage caused by splashing liquid onto it

NOTICE

Any computer used with the equipment must comply with EN/IEC

60950-1, and be installed and used according to the manufacturer's

instructions.

Flammable liquids and explosive

environment

WARNING

ReadyToProcess WAVE 25 is not designed to handle flammable

liquids.

WARNING

ReadyToProcess WAVE 25 is not approved for work in a potentially

explosive atmosphere.

Personal protection

WARNING

Always use appropriate Personal Protective Equipment (PPE) during

operation and maintenance of this product.

ReadyToProcess WAVE 25 Operating Instructions 29009597 AD 19

2 Safety instructions

2.1 Safety precautions

WARNING

Hazardous substances. When using hazardous chemical and

biological agents, take all suitable protective measures, such as

wearing protective glasses and gloves resistant to the substances

used. Follow local and/or national regulations for safe operation,

maintenance and decommissioning of the system.

WARNING

Spread of biological agents. The operator must take all necessary

actions to avoid spreading hazardous biological agents. The facility

must comply with the national code of practice for biosafety.

Installing and moving the

equipment

CAUTION

Heavy object. Because of the significant weight of ReadyToProcess

WAVE 25 rocker, assistance from another person is highly recom-

mended when lifting or moving the equipment. Use the handles

on the sides of the rocker when possible. Do not lift ReadyToProcess

WAVE 25 rocker with tray attached.

CAUTION

Due to the size and weight of Tray 50, at least two persons are

recommended for installing the tray.

CAUTION

Falling equipment. Do not stack more than one ReadyToProcess

CBCU and/or ReadyToProcess Pump 25 unit on top of each other.

20 ReadyToProcess WAVE 25 Operating Instructions 29009597 AD

2 Safety instructions

2.1 Safety precautions

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GE ReadyToProcess WAVE 25 Operating Instructions Manual

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