cytiva ReadyToProcess Mixer 20/50 User manual

ReadyToProcess™
Mixer 20/50
Operating Instructions
Original instructions
cytiva.com

Table of Contents
1 Introduction ........................................................................................................ 4
1.1 Important user information ....................................................................................................................... 5
1.2 About this manual ......................................................................................................................................... 6
2 Safety instructions ............................................................................................. 7
2.1 Safety precautions ........................................................................................................................................ 8
2.2 Labels and symbols ....................................................................................................................................... 16
2.3 Emergency procedures ............................................................................................................................... 18
2.4 Danger zones ................................................................................................................................................... 19
3 Instrument description ...................................................................................... 21
3.1 Configuration .................................................................................................................................................. 22
3.2 Illustrations ...................................................................................................................................................... 23
3.3 Control software ............................................................................................................................................ 26
3.3.1 The main screen ............................................................................................................................................ 27
3.3.2 General screen functions .......................................................................................................................... 28
4 Installation .......................................................................................................... 29
4.1 Site requirements .......................................................................................................................................... 30
4.2 Unpacking ......................................................................................................................................................... 32
4.3 Set up the rocking unit ................................................................................................................................. 33
4.4 Set up the temperature control system ................................................................................................ 35
4.5 Moving the instrument ................................................................................................................................ 37
5 Preparation ......................................................................................................... 38
6 Operation ............................................................................................................ 40
6.1 Start the instrument ..................................................................................................................................... 41
6.2 Operation settings ........................................................................................................................................ 42
6.3 Perform a run ................................................................................................................................................... 48
6.4 Procedures after a run ................................................................................................................................. 53
7 Maintenance ....................................................................................................... 55
7.1 General maintenance .................................................................................................................................. 56
7.2 Calibration ........................................................................................................................................................ 58
7.3 Safety switch inspection ............................................................................................................................. 60
7.4 Replacement of fuses ................................................................................................................................... 62
7.5 Communications and data acquisition ................................................................................................. 63
7.6 Cleaning before planned service ............................................................................................................. 66
8 Troubleshooting ................................................................................................. 67
8.1 Troubleshooting guide ................................................................................................................................. 68
8.2 Alarms ................................................................................................................................................................ 71
9 Reference information ....................................................................................... 75
9.1 Specifications .................................................................................................................................................. 76
Table of Contents
ReadyToProcess Mixer 20/50 Operating Instructions 28964134 AF 2

9.2 Recycling information .................................................................................................................................. 79
9.3 Regulatory information ............................................................................................................................... 80
9.3.1 Contact information .................................................................................................................................... 81
9.3.2 European Union and European Economic Area .............................................................................. 82
9.3.3 Great Britain ................................................................................................................................................... 83
9.3.4 Eurasian Economic Union (Евразийский экономический союз) .......................................... 84
9.3.5 North America ............................................................................................................................................... 86
9.3.6 Regulatory statements .............................................................................................................................. 87
9.3.7 Declaration of Hazardous Substances (DoHS) ................................................................................ 88
9.4 Spare parts, accessories and ordering information ......................................................................... 90
9.5 Health and Safety Declaration Form ...................................................................................................... 91
Appendix A: ReadyToProcess Mixer 20/50 theory of operation ........................... 93
Index ........................................................................................................................... 96
Table of Contents
ReadyToProcess Mixer 20/50 Operating Instructions 28964134 AF 3

1 Introduction
About this chapter
This chapter contains important information about ReadyToProcess Mixer™ 20/50 and
scope of the manual.
In this chapter
Section See page
1.1 Important user information 5
1.2 About this manual 6
1 Introduction
ReadyToProcess Mixer 20/50 Operating Instructions 28964134 AF 4

1.1 Important user information
Introduction
This section contains important user information about the product and this manual.
Read this before operating the
product
All users must read the entire Operating Instructions before installing, oper-
ating, or maintaining the product.
Always keep the Operating Instructions at hand when operating the product.
Do not install, operate, or perform maintenance on the product in any other way than
described in the user documentation. If you do, you may be exposed or expose others
to hazards that can lead to personal injury and you may cause damage to the equip-
ment.
Intended use of the product
ReadyToProcess Mixer 20/50 is an instrument for mixing, warming, and reconstituting
materials contained in sealed plastic bags.
ReadyToProcess Mixer 20/50 is intended for research use only, and shall not be used in
any clinical or in vitro procedures, or for diagnostic purposes.
Prerequisites
In order to operate ReadyToProcess Mixer 20/50 in the way it is intended:
•The user must be acquainted with the use of general laboratory equipment and with
handling of biological materials.
•The user must read and understand the Safety instructions chapter in the Operating
Instructions.
•ReadyToProcess Mixer 20/50 must be installed according to the instructions in the
Installation chapter of the Operating Instructions.
1 Introduction
1.1Important user information
ReadyToProcess Mixer 20/50 Operating Instructions 28964134 AF 5

1.2 About this manual
Introduction
This section contains information about the purpose and scope of this manual, notes
and tips, and typographical conventions.
Purpose of this manual
This manual provides information needed to install, operate and maintain the product
in a safe way.
Scope of this manual
This manual is valid for ReadyToProcess Mixer 20/50 instrument, including
MIXER20/50EHT and MIXER20/50EHT-L.
Detailed information regarding bioprocessing bags, M*Bag, or other disposable
consumables is not covered.
In this manual MIXER20/50EHT and MIXER20/50EHT-L are collectively referred to as
ReadyToProcess Mixer 20/50. The MIXKIT20, MIXKIT20EH, MIXKIT50, and MIXKIT50EH
bag trays are referred to as MIXKIT bag tray.
Notes and tips
Note: A note is used to indicate information that is important for trouble-free and
optimal use of the product.
Tip: A tip contains useful information that can improve or optimize your proce-
dures.
Typographical conventions
Software items are identified in the text by bold italic text.
Hardware items are identified in the text by bold text.
Tip: The text can include clickable hyperlinks to reference information.
Associated documentation
Translations of the Operating Instructions are available on translation CD (28964136).
1 Introduction
1.2 About this manual
ReadyToProcess Mixer 20/50 Operating Instructions 28964134 AF 6

2 Safety instructions
About this chapter
This chapter describes safety precautions, labels and symbols that are attached to the
instrument. In addition, the chapter describes emergency and recovery procedures.
In this chapter
Section See page
2.1 Safety precautions 8
2.2 Labels and symbols 16
2.3 Emergency procedures 18
2.4 Danger zones 19
Important
WARNING
All users must read and understand the entire contents of
this general safety chapter, and the specific safety precau-
tions information in each subsequent chapter of this manual
to become aware of the hazards involved.
2 Safety instructions
ReadyToProcess Mixer 20/50 Operating Instructions 28964134 AF 7

2.1 Safety precautions
Introduction
ReadyToProcess Mixer 20/50 is powered by mains voltage and handles materials that
can be hazardous.
Before installing, operating or maintaining the system, you must be aware of the
hazards described in this manual.
Definitions
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
proceed 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.
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.
2 Safety instructions
2.1 Safety precautions
ReadyToProcess Mixer 20/50 Operating Instructions 28964134 AF 8

WARNING
Do not use any accessories not supplied or recommended by
Cytiva.
WARNING
The heater connector (blue cable) must be plugged in before plug-
ging in the mains cable. The heater outlet operates at line voltage.
Do not operate the unit without connecting the heater pad.
WARNING
Risk of spillage. Disconnect the power supply when handling the
M*Bag.
WARNING
Spillage risk. If liquid is spilled on instrument, disconnect the
power source and contact a Cytiva service representative.
CAUTION
Pinch hazard. Do not insert any body parts between the rocker
base and MIXKIT bag tray.
CAUTION
Do not fill the M*Bag more than the specified capacity. A larger fill
volume damps out the wave motion and drastically reduces the
mixing efficiency.
CAUTION
Always keep the M*Bag inside the MIXKIT bag tray when not placed
on the Mixer base unit.
CAUTION
Make sure that all tubing, hoses and cables are placed so that the
risk of tripping accidents is minimized.
2 Safety instructions
2.1 Safety precautions
ReadyToProcess Mixer 20/50 Operating Instructions 28964134 AF 9

NOTICE
Any computer used with the equipment must comply with
IEC 60950 and be installed and used according to the manufac-
turer's instructions.
Personal protection
WARNING
Always use appropriate Personal Protective Equipment (PPE)
during operation and maintenance of this product.
WARNING
Hazardous substances and biological agents. When using
hazardous chemical and biological agents, take all suitable protec-
tive measures, such as wearing protective clothing, glasses and
gloves resistant to the substances used. Follow local and/or
national regulations for safe operation and maintenance of this
product.
WARNING
Spread of biological agents. The operator must take all neces-
sary actions to avoid spreading hazardous biological agents. The
facility must comply with the national code of practice for
biosafety.
Flammable liquids and explosive
environment
WARNING
ReadyToProcess Mixer 20/50 is not designed to handle flammable
liquids.
WARNING
ReadyToProcess Mixer 20/50 is not approved for work in a poten-
tially explosive atmosphere.
2 Safety instructions
2.1 Safety precautions
ReadyToProcess Mixer 20/50 Operating Instructions 28964134 AF 10

Installing and moving the instrument
WARNING
The instrument must not be used for any application other than
specified by the manufacturer. Only use M*Bags or Cytiva
approved bags on the instrument. Dispose of used bags according
to local laws and regulations.
CAUTION
Heavy object. Do not lift or move the instrument without assis-
tance. Use the handles on the sides of the instrument when lifting
or moving. Do not lift the instrument with a MIXKIT bag tray
attached.
CAUTION
Heavy object. Due to the size and weight of MIXKIT50EH bag tray,
at least two persons are recommended for installing the bag tray.
CAUTION
Heavy object. Filled M*Bag is heavy and must be lifted with care.
This also applies to optional equipment such as calibration
weights.
CAUTION
Make sure that there is enough free space around the Instrument
for the rocking motion.
Power supply
WARNING
Installing the computer. The computer must be installed and
used according to the instructions provided by the manufacturer of
the computer.
2 Safety instructions
2.1 Safety precautions
ReadyToProcess Mixer 20/50 Operating Instructions 28964134 AF 11

WARNING
Protective ground. The product must always be connected to a
grounded power outlet.
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 instru-
ment before connecting ReadyToProcess Mixer 20/50 units to any
other instrument.
WARNING
Electrical shock hazard after spillage. If there is a risk that large
volumes of spilled liquid may penetrate the casing of the instru-
ment, immediately switch off the instrument, disconnect the
power cord, and contact an authorized service engineer.
WARNING
Electrical shock hazard. All repairs should be done by service
personnel authorized by Cytiva. Do not open any covers or replace
parts unless specifically stated in the user documentation.
WARNING
Disconnect power. Always disconnect power from the instru-
ment before replacing fuses.
WARNING
If a fuse requires repeated replacement, do not continue to use the
instrument. Contact an authorized service engineer.
2 Safety instructions
2.1 Safety precautions
ReadyToProcess Mixer 20/50 Operating Instructions 28964134 AF 12

WARNING
For continued protection from fire hazard, replace only with same
type and rating of fuse.
CAUTION
Do not connect power to the instrument until it is completely dry.
Operation
WARNING
Use only the following MIXKIT bag trays in ReadyToProcess Mixer
20/50:
•MIXKIT20 (product code 28411573)
•MIXKIT50 (product code 28411576)
•MIXKIT20EH 100-120 V (product code 28951479)
•MIXKIT20EH 220-240 V (product code 28952627)
•MIXKIT50EH 100-120 V (product code 28951480)
•MIXKIT50EH 220-240 V (product code 28952628)
WARNING
Burning hazard. In case of error, some surfaces may become hot
with temperatures above 75°C, which is the normal maximum
temperature. The heater has a thermal shut off when surface
temperature exceeds 90°C.
WARNING
Burning hazard. Take care when the heater is activated. The
MIXKIT bag tray and M*Bag can become hot, specifically when the
heater is set to maximum temperature (55°C).
CAUTION
Leakage risk of biological substances. Before every use, check
the integrity of all tubing and connections.
2 Safety instructions
2.1 Safety precautions
ReadyToProcess Mixer 20/50 Operating Instructions 28964134 AF 13

CAUTION
Only M*Bag approved by Cytiva for ReadyToProcess Mixer 20/50
may be used together with the equipment.
CAUTION
Leakage risk of biological substances. Always enter the correct
M*Bag size in the system software settings. Failure to do this may
cause overpressure and subsequent rupture of the M*Bag.
CAUTION
Falling equipment. To prevent ReadyToProcess units from acci-
dentally being pulled from the bench, make sure that all tubing is
kept inside the bench area.
CAUTION
Falling equipment. Do not stack more than one M*Bag 20 L
and/or M*Bag 50 L unit on top of each other.
CAUTION
To avoid overheating, do not operate the heater for more than a
few minutes without a filled cell bag on the MIXKIT bag tray.
CAUTION
Do not use the product in a dusty atmosphere or close to spraying
water.
NOTICE
Take care when tilting the MIXKIT bag tray with a filled M*Bag
attached.
2 Safety instructions
2.1 Safety precautions
ReadyToProcess Mixer 20/50 Operating Instructions 28964134 AF 14

Maintenance
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 before connecting to a mains power source. Make sure to follow
all environmental, health, and safety guidelines pertaining to the
materials used.
WARNING
Disconnect power. Always disconnect power from the instru-
ment before performing any maintenance task.
WARNING
Use only approved parts. Only spare parts and accessories that
are approved or supplied by Cytiva may be used for maintaining or
servicing the product.
CAUTION
Do not apply liquid directly to the instrument.
2 Safety instructions
2.1 Safety precautions
ReadyToProcess Mixer 20/50 Operating Instructions 28964134 AF 15

2.2 Labels and symbols
Introduction
This section describes the nameplate, labels, and other safety information attached to
the product.
Nameplate
The nameplate provides information about the model, manufacturer, and technical
data.
Description of symbols and text
The following symbols may be present on the system label.
Symbol/text Meaning
Warning! Read the user documentation before using the system.
Do not open any covers or replace parts unless specifically stated
in the user documentation.
Code no Instrument assembly number
Serial no Instrument serial number
Mfg Year Manufacturing year
Voltage Electrical rating:
•Voltage (VAC )
Frequency Electrical rating: Frequency (Hz)
Max Power Electrical rating: Max. power (VA)
Fuse rating Fuse rating: number of fuses, type F (fast), trip current (A),
maximum voltage (V)
2 Safety instructions
2.2 Labels and symbols
ReadyToProcess Mixer 20/50 Operating Instructions 28964134 AF 16

Safety labels
The table below describes the various safety labels that may be found on the product.
Symbol/text Description
Warning! High Voltage. Always make sure that the
system is disconnected from electric power before
opening the cabinet doors or disconnecting any elec-
tric device.
Warning! Indicates a hot surface and that care must
be exercised to prevent injury.
This symbol indicates risk of pinch injury. This sign is
located near the rocker.
2 Safety instructions
2.2 Labels and symbols
ReadyToProcess Mixer 20/50 Operating Instructions 28964134 AF 17

2.3 Emergency procedures
Introduction
This section describes how to shut down the instrument in an emergency situation.
The section also describes the safety switch and the result in the event of power failure.
Emergency shutdown
In an emergency situation, follow the steps below to stop the run:
Step Action
1Switch off the power to the instrument by pressing the Power switch to the
O position.
2Disconnect the Power cord from the Power outlet.
Safety switch
Safety switches are located on top of the base unit. If any of the safety switches are hit,
the rocking motion stops and brings the rocking unit to a level position. If a safety
switch has been hit, the power must be switched off (the O position) and then on (the I
position) again to reset the safety switch.
Power failure
Power failure to... will result in...
ReadyToProcess Mixer
20/50
•The run is interrupted immediately
•The operation settings remain stored in the touch
panel control (backup batteries has a life of 5 to 10
years)
•If the AUTOSTART option is set to ON, the opera-
tion is automatically resumed on power up.
2 Safety instructions
2.3 Emergency procedures
ReadyToProcess Mixer 20/50 Operating Instructions 28964134 AF 18

2.4 Danger zones
Top view danger zones
CAUTION
Pinch hazard. Do not insert any body parts between the rocker
base and MIXKIT bag tray.
A danger zone exists around ReadyToProcess Mixer 20/50 30.5 cm (12 inches) from
each side of the unit. The danger zone must be kept clear of obstructions. Clean spills
immediately to not cause a slip hazard which could lead to injury.
Make sure you fully understand the potential hazards indicated by the labels described
in Safety labels, on page 17.
Area Description
1 and 2 Danger zone,30.5 × 55.2 cm (12 × 21.7 inches). Keep the area clear
of all obstructions.
Front view danger zone
CAUTION
Pinch hazard. Do not insert any body parts between the rocker
base and MIXKIT bag tray.
For correct ventilation, the instrument requires a free space of 10 cm (4 inches) behind
and in front of it. Do not place soft material under the rocker unit as it can block the
ventilation inlet.
2 Safety instructions
2.4 Danger zones
ReadyToProcess Mixer 20/50 Operating Instructions 28964134 AF 19

Area Description
1 Keep clear of all obstructions.
2 Safety instructions
2.4 Danger zones
ReadyToProcess Mixer 20/50 Operating Instructions 28964134 AF 20