1045.1Set up the system .................................................................................................................................
1055.1.1Select the tray and Cellbag bioreactor .................................................................................
1065.1.2Attach and detach tray ................................................................................................................
1095.1.3Prepare pH and DO sensors ......................................................................................................
1125.1.4Attach the Cellbag bioreactor ...................................................................................................
1145.1.5Prepare the pump ..........................................................................................................................
1195.1.6Connect gas to the system ........................................................................................................
1235.2Start and configure the system .....................................................................................................
1245.2.1Start the system and log on to UNICORN ...........................................................................
1255.2.2Connect to the system .................................................................................................................
1275.2.3Configure system properties .....................................................................................................
1295.2.4Configure system settings ..........................................................................................................
1315.2.5Start a run .........................................................................................................................................
1355.3Prepare for cultivation ........................................................................................................................
1365.3.1Inflate the Cellbag bioreactor ...................................................................................................
1455.4.1Inoculate the culture .....................................................................................................................
1465.4.2Monitor the run ...............................................................................................................................
1485.4.3End a run ...........................................................................................................................................
4ReadyToProcess WAVE 25 Operating Instructions 29009597 AD
1Introduction
About this chapter
This chapter contains important user information, the intended use of ReadyToProcess
WAVE 25, description of safety notices, and regulatory information.
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 identifiedin the textby bold italic text. A colonseparates 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(for example, \Program Files\GE Healthcare\UNICORN\).
6ReadyToProcess WAVE 25 Operating Instructions 29009597 AD
1.2Important user information
Read the Operating Instructions
before operating the product
All users must read the entire separate Operating Instructions before installing, operating, 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 userdocumentation.
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 manufacturing equipment for cell cultivation. The system may not be used for clinical or diagnostic purposes.
1 Introduction
1.2 Important user information
Prerequisites
In orderto follow this manual and use the system in the intended manner, itis important
that:
•
you have a general understanding of how the client computer and Microsoft®Windows®operating systems work.
•
you areacquainted with the use of general laboratory equipment and with handling
of biological materials.
•
you have read and understood the Safety instructions chapter in these OperatingInstructions.
•
the system is installed according to the instructions in these Operating Instructions.
•
a useraccount has been created according to UNICORN Administrationand Technicalmanual.
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.
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 acceptany interferencereceived, including interference thatmay cause undesired
operation.
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 reasonable protection against harmful interference when the equipment is operated in a
commercial environment. This equipmentgenerates, uses,and can radiateradio frequency 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 required to correct the interference at his own expense.
12ReadyToProcess WAVE 25 Operating Instructions 29009597 AD
The user is cautioned that anychanges or modifications not expressly approved
by GE could void the user’s authority to operate the equipment.
1.3.4Other regulations and standards
Environmental conformity
This product conforms to the following environmental requirements.
TitleRequirement
1 Introduction
1.3 Regulatory information
1.3.4 Other regulations and standards
China RoHS
Standards, machinery and
electrical equipment
Standard requirements fulfilled by this product are summarized in the table below.
EN ISO 12100
EN 61010-1, IEC 61010-1,
UL 61010-1, CAN/CSAC22.2 No. 61010-1
IEC/EN 61010-2-010
EN 61326-1
Management Methods for the Restriction of the Use of Hazardous Substances in Electrical and Electronic Products.
DescriptionStandard
Safety of machinery. General principles for design. Risk
assessment and risk reduction.
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General
requirements.
Particular requirements for laboratory equipment for
the heating of materials
Electrical Equipment for Measurement, Control, and
Laboratory Use-EMC requirements-Part 1: General requirements
(Emission according to CISPR 11, Group 1, class A)
NOTICE
This equipmentis not intended for
use in residential environments
and may not provide adequate
protection to radio reception in
such environments.
The software used for controlling andmonitoring the
system.
1 Introduction
1.5 User documentation
1.5User documentation
The table below describes the user documentation for ReadyToProcess WAVE25, which
is available from the Help menu in UNICORN or on the user documentation CD.
Main contentsDocument
ReadyToProcess WAVE 25
Operating instructions
ReadyToProcess WAVE 25
System Handbook
ReadyToProcessWAVE25 Cue
Card
UNICORN Administration and
Technical manual
User Documentation CD
Instructions neededto install,operate andmaintain
ReadyToProcess WAVE 25 in a safe way. Includes
basic UNICORN 7.0 system control functions.
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, togetherwith evaluationand presentation
of data.
Brief instructions providing an overview of how to
run the system.
Overview and detailed description of networksetup
and complete software installation. Administration
of UNICORN and the UNICORN database.
Dialog descriptions for UNICORN 7.0.UNICORN Online Help
CD containing the listed manuals and translated
versions of ReadyToProcess WAVE 25 Operatinginstructions.
16ReadyToProcess WAVE 25 Operating Instructions 29009597 AD
2Safety 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.
ReadyToProcess WAVE 25 is powered by mains voltage andhandles materials that may
be hazardous.Before installing,operating or maintainingthe system, you must beaware
of the hazards described in this manual.
Follow the instructions provided to avoid personal injuries, damage to the cell cultures, 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.
18ReadyToProcess WAVE 25 Operating Instructions 29009597 AD
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, andbe installed and used accordingto the manufacturer's
instructions.
Flammable liquids and explosive
environment
2 Safety instructions
2.1 Safety precautions
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 useappropriate PersonalProtective Equipment(PPE) during
operation and maintenance of this product.
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 operatormust take all necessary
actions toavoid spreading hazardous biological agents.The facility
must comply with the national code of practice for biosafety.
CAUTION
Heavy object. Because of the significantweight of ReadyToProcess
WAVE 25 rocker, assistance from another person is highly recommended when lifting or moving the equipment. Use the handles
on thesides of therocker when possible. Do notlift 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.
20ReadyToProcess WAVE 25 Operating Instructions 29009597 AD
Power supply
2 Safety instructions
2.1 Safety precautions
WARNING
Supply voltage. Before connectingthe powercord, make sure that
the supply voltage at the wall outlet corresponds to the marking
on the instrument.
WARNING
Protective ground. bioreactor stand-alone instruments must al-
ways be connected to a grounded power outlet.
WARNING
Only use grounded power cords delivered or approved by GE.
WARNING
Access to power switch and power cord with plug. Do not block
access to the power switch and power cord. The power switch
must always be easy to access. The power cord with plug must
always be easy to disconnect.
WARNING
Disconnect power. Always disconnect power from the equipment
before connecting the ReadyToProcessWAVE 25 units toany other
instrument.
If UniNet cables are disconnected during a run, the run will be interrupted and must be restarted. Make sure that cables are properly secured before starting a run and avoid moving system units
during a run.
WARNING
Electrical shock hazard. All repairs should be done by service
personnel authorized by GE. Do not open any covers or replace
parts unless specifically stated in the user documentation.
WARNING
Disconnect power. Always disconnect power from the instrument
before performing any maintenance task.
WARNING
Always clean the equipment in a well ventilated area. Never
immerse any part of the equipment in liquid or spray liquid on the
equipment. Always make sure that the equipment is completely
dry beforeconnecting to a mains powersource. Make sure to follow
all environmental, health, and safety guidelines pertaining to the
materials used.
WARNING
Use only approved parts. Only spare parts and accessories that
are approved or supplied by GE may be used for maintaining or
servicing the product.
24ReadyToProcess WAVE 25 Operating Instructions 29009597 AD
2 Safety instructions
2.1 Safety precautions
CAUTION
Falling equipment. Due to pinch and crush hazards, calibration
weights should not be stacked on top of each other. Remove calibration weights before the power is turned off.
CAUTION
Hazardous substances. Before maintenance,service and decom-
missioning, clean the ReadyToProcess WAVE 25 system with an
appropriate cleaningagent to removeany hazardous substances.
This section describes the various labels that are attached to the system units. The illustrations in this section are examples of labels found on various parts of the system. For
information aboutmarking of the client computerequipment, refer to the manufacturer's
instructions.
In this section
See pageSection
272.2.1 Instrument labels
312.2.2 Safety labels
332.2.3 Additional labels
26ReadyToProcess WAVE 25 Operating Instructions 29009597 AD
2.2.1Instrument labels
29044471Filter Heater
Code no: 29036750
Mfg Year: YYYY/MM
Voltage: 32 V DC
Max Power: 4 W
Made in Sweden
GE Healthcare Bio-Sciences AB
751 84 Uppsala Sweden
ReadyToProcessWAVE 25 rocker
label
The following illustration shows an example of the label located on the back of the
rocker and underneath the rocker platform.
Filter heater label
The following illustration shows an example of the label attached to the filter heater.
The following illustrations show examples of the labels attached to the trays and lids.
Tray label
Lid label
ReadyToProcess CBCU label
The instrument label on the CBCU is located on the underside of theunit. The illustration
below isan example of the label attached to aCBCU with full configuration. Corresponding
labels are attached to the CBCU units with alternative configurations.
28ReadyToProcess WAVE 25 Operating Instructions 29009597 AD
ReadyToProcess Pump 25 label
The following illustraton shows an example of the label located on the rear panel of the
pump.
Symbol description
The following symbols are used in the labels.
2 Safety instructions
2.2 Labels
2.2.1 Instrument labels
DescriptionLabel
Warning! Read the user documentation before using the sys-
tem. Donot open anycovers or replace partsunless specifically
stated in the user documentation.
This symbol indicates that electrical and electronic equipment
must notbe disposed of as unsorted municipal waste andmust
be collectedseparately. Please contact an authorizedrepresentative of the manufacturer for information concerning the decommissioning of equipment.
This symbol indicates that the product contains hazardous
materials in excess of the limits established by the Chinese
standard GB/T 26572 Requirements for Concentration Limits
for Certain Hazardous Substances in Electrical and Electronic
Products.
This symbolindicates thatthe systemcomplies withapplicable
European directives.
This symbolindicates thatthe systemcomplies withapplicable
requirements for Australia and New Zealand.
Eurasian Conformitymark: the singleconformity markindicates
that the product is approved for circulation on the markets of
the member states of the Eurasian Customs Union.
This symbol indicates that ReadyToProcess WAVE 25 hasbeen
certified by a Nationally Recognized Testing Laboratory (NRTL).
This product Conforms to UL 61010-1, and is Certified to
CAN/CSA-C22.2 No. 61010-1.
Electrical requirements:Voltage
Voltage (VAC)
•
Voltage (VDC)
•
Frequency (Hz)
•
Max. power (VA)
•
Degree of protection provided by the enclosure.Protection Class
CAN ICES-1/NMB1
Year (YYYY) and month (MM) of manufactureMfg. Year
CAN ICES-1/NMB-1 indicates that this product complies with
the Canadianstandard ICES-001 concerning technical requirements relative to radiated noise emissions from Industrial, Scientific and Medical radio frequency generators.
30ReadyToProcess WAVE 25 Operating Instructions 29009597 AD
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