Miltenyi Biotec CliniMACS User manual

CliniMACS® Workbench
User Manual
For U.S. CAUTION:
Clinical Research System Limited by Federal (or United States) Law to Investigational
Use or under an FDA Approval
Version 1
Original instructions

The CliniMACS Workbench is a MACS GMP Instrument. MACS GMP Instruments are for ex vivo cell processing only,
and are not intended for human in vivo applications. They are intended to be used as manufacturing equipment
for cell-based medicinal products. MACS GMP Instruments are manufactured and tested under a quality
management system (ISO 13485) and are in compliance with relevant GMP guidelines.
The availability of the CliniMACS Workbench models may vary depending on your geographic location and on the
individual releases of the different models. For more information, contact your local Miltenyi Biotec
representative.
Copyright © 2022 Miltenyi Biotec and/or its affiliates. All rights reserved.
No part of this publication may be reproduced, stored in a retrieval system, transmitted, published, or distributed in
any form or by any means, electronically, mechanically, by photocopying, microfilming, recording, or otherwise,
without the prior written consent of Miltenyi Biotec; however, notwithstanding the foregoing, the owners of the
CliniMACS Prodigy System may make copies solely for purposes of training personnel in the use and servicing of the
unit within their business or organization.
CliniMACS, CliniMACS Prodigy, MACS, and the Miltenyi Biotec logo are registered trademarks or trademarks of Miltenyi
Biotec B.V. & Co. KG and/or its affiliates in various countries worldwide. All other trademarks mentioned in this
document are the property of their respective owners and are used for identification purposes only.

CliniMACS® Workbench
User Manual
Issued: 2022-06
210-003-200/02
For U.S. distributed by:
Miltenyi Biotec B.V. & Co. KG
Friedrich-Ebert-Straße 68
51429 Bergisch Gladbach
Germany
Miltenyi Biotec Inc.
2303 Lindbergh Street
Auburn, CA 95602
USA
Miltenyi Biotec Technical Support
[phone]
technicalsuppor[email protected]
www.miltenyibiotec.com

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Essential information
This user manual provides instructions, warnings, precautions, and other
important information for the use of the CliniMACS Workbench. Further safety
information regarding the operation the CliniMACS Prodigy® System is provided
in the CliniMACS Prodigy User Manual (Instrument).
Equipment safety may be compromised. Equipment safety may be
compromised if the instrument is not used according to the manufacturer’s
instructions.
The operation of the CliniMACS Workbench must be performed by
professional users only. Before putting the CliniMACS Workbench into
operation, the operator must read and understand the safety information,
warnings, precautions, and instructions for proper operation of the
CliniMACS Workbench provided in this user manual (including, without
limitation, the safety information in chapter 3 of this document) and in the
CliniMACS Prodigy User Manual (Instrument), and in any safety-related
recommendations issued by Miltenyi Biotec. Pay special attention to all
warnings displayed on the CliniMACS Prodigy, or provided with CliniMACS
Workbench, consumables and accessories. Adhere to all instructions and
procedures at all times during the operation of the instrument, confirming
that all safety information, warnings, precautions, and instructions are
observed. Failure to follow the safety information, warnings, precautions,
and instructions contained in the instructions for use could result in
instrument malfunction, property damage, personal injury, and/or death.
Retain the user manuals for future reference. They should be kept
accessible and readily available together with all other safety and
operating documentation during the entire lifecycle of the instrument for
all personnel responsible for installation, operation, and maintenance.

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Table of contents
1 Introduction 9
1.1 General information 9
1.2 Service information 10
1.2.1 CliniMACS Workbench information 10
1.2.2 Technical support 10
2 Glossary 11
2.1 Graphical depiction 11
2.2 Glossary of symbols and terms 12
3 Important safety information 13
3.1 Safety instructions 16
3.1.1 Usage and installation 16
3.1.2 Hazards of electric shock and spread of fire 16
3.1.3 Mechanical hazards 17
3.1.4 Gas hazards 18
3.1.5 Chemical and biological hazards 18
3.1.6 Servicing and transport 19
3.2 Position of safety symbols 20

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4 The CliniMACS Workbench 21
4.1 Regulatory information 21
4.2 The CliniMACS Workbench within the CliniMACS Prodigy Cell &
Gene Therapy Manufacturing System 22
4.2.1 Intended use 22
4.2.2 Compliance 23
4.3 Technical data 24
4.4 Components 26
4.4.1 Accessory power outlet 28
4.4.2 Main switch 28
4.4.3 Brake pedal 29
4.4.4 Hooks 30
4.4.5 Central supplies 31
4.4.6 Storage compartment 33
4.4.7 Uninterruptible power supply (UPS) 33
4.4.8 Connectors to the CliniMACS Prodigy 34
4.5 Unpacking and installation 34
4.5.1 Scope of supply 34
4.5.2 Connection of the central supplies to the ceiling socket 35
4.5.3 Placement of the CliniMACS Prodigy Supplementary Bag 36
4.5.4 Positioning 37
4.5.5 Transport 37
4.6 Cleaning and disinfection 38
4.7 Maintenance 38
4.7.1 Servicing 38
4.8 Disposal 39
Table of contents (continued)

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Table of contents (continued)
5 The CliniMACS Workbench within the CliniMACS Prodigy
Cell & Gene Therapy Manufacturing System 41
5.1 System components 41
5.2 Additional materials and equipment 41
5.3 Limitation 42
5.4 Warnings and precautions regarding the process 42
6 Troubleshooting 43
7 Legal notes 45
7.1 Limited warranty 45
7.2 Trademarks 46
7.3 EU/EC Declaration of conformity 47
7.4 UK Declaration of conformity 48
Appendix 49
Guidance and manufacturer’s declaration on electromagnetic
compatibility

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9
1
INTRODUCTION
1
Introduction
1.1 General information
The CliniMACS Workbench is a movable workbench specifically designed for the
CliniMACS Prodigy and its accessories. The CliniMACS Workbench enables the
user to place the CliniMACS Prodigy in a flexible and stable way, with the
possibility to establish power, data, alarm, and gas connections via the ceiling of
the facility environment. In case of a temporary power interruption, a proper
continuation of the processes on the CliniMACS Prodigy is ensured by the
integrated uninterruptible power supply. Different models of the CliniMACS
Workbench offer the selection between the CliniMACS Workbench for the
CliniMACS Prodigy only and the CliniMACS Workbench Large for the CliniMACS
Prodigy in combination with the CliniMACS Electroporator.
Model Catalogue number
CliniMACS Workbench with central supplies, HV-UPS1170 - 075 -711
CliniMACS Workbench with central supplies, LV-UPS1170 -075-712
CliniMACS Workbench Large with central supplies, HV-UPS1170-075-713
CliniMACS Workbench Large with central supplies, LV-UPS2170 -075-714
1 within the range of 208–240 V
2 within the range of 100–127 V
Table 1.1: Different available CliniMACS Workbench models

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1.2 Service information
1.2.1 CliniMACS Workbench information
Record below the model and serial number located on the rear of the instrument.
Refer to these numbers when requesting information about the instrument or
when requesting instrument service.
Catalogue no. (REF):
Serial no. (SN):
1.2.2 Technical support
For information about the instrument and its components, contact Miltenyi Biotec
Technical Support:
Miltenyi Biotec B.V. & Co. KG
Friedrich-Ebert-Straße 68
51429 Bergisch Gladbach
Germany
[phone]
technicalsuppor[email protected]
Visit www.miltenyibiotec.com for local Miltenyi Biotec Technical Support contact
information.

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2
GLOSSARY
2
Glossary
2.1 Graphical depiction
The following chart depicts the panels used in this user manual to inform the user
about potential risks if the outlined warnings and precautions are not followed.
The hazard level classifies the hazard, as described below. The level, type, and
source of the hazard, as well as potential consequences, prohibitions, and
measures are indicated as follows. Icons on the left side specify the risk.
Indicates a hazardous situation that, if not avoided, could result in death or
serious injury.
Indicates a hazardous situation that, if not avoided, could result in minor or
moderate injury.
Indicates information considered important, but not hazard-related (e.g.
messages relating to property damage).
IMPORTANT
Advises the user of important practices or information not related to personal injury
nor property damage.

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2.2 Glossary of symbols and terms
An overview of symbols and terms used for the CliniMACS Prodigy System is
provided in the CliniMACS Prodigy User Manual (Instrument). The glossary of
symbols depicts the symbols used for labeling of the CliniMACS products.
Additional symbols and terms are given below.

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3
IMPORTANT SAFETY INFORMATION
3
Important safety information
Equipment safety will be compromised. If the instrument is not used
according to the manufacturer’s instructions equipment safety will be
compromised. The operation of the instrument must be performed by
professional users only. Before putting the instrument into operation,
carefully read and understand the safety information, warnings,
precautions, and instructions for proper operation of the instrument
provided in the instructions for use of the CliniMACS Prodigy System
components (including, without limitation, the safety information in this
chapter) and in any safety-related recommendations issued by Miltenyi
Biotec. Pay special attention to all warnings on the CliniMACS Prodigy and
CliniMACS Workbench or provided with consumables and accessories. The
operator must adhere to all instructions and procedures at all times during
the operation of the instrument, confirming that all safety information,
warnings, precautions, and instructions are observed.
Retain the user manuals for future reference. They should be kept
accessible and readily available together with all other safety and
operating documentation during the entire lifecycle of the instrument for
all personnel responsible for installation, operation, and maintenance.

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Hazards to users, instrument damage, and/or malfunction, unpredictable
results, premature wear and tear, and/or reduced lifetime of the
instrument. If the following safety information, warnings, precautions, and
instructions are not observed this can cause hazards to users, instrument
damage, and/or malfunction, unpredictable results, premature wear and
tear, and/or reduced lifetime of the instrument. Observe the following
safety information, warnings, precautions, and instructions at all times
when using the instrument.
• Always operate, handle, use, and maintain the instrument in accordance with
the safety information, warnings, precautions, instructions and recommended
procedures provided in the CliniMACS Workbench User Manuals and other
written instructions issued by Miltenyi Biotec. Do not deviate from these
operating instructions and procedures.
• Always ensure that the instrument is operated, handled, used and maintained
only by appropriately skilled and professional personnel familiar with the
construction, operation, and hazards involved with the instrument. The
instrument is intended for the use in the professional facility healthcare
environment. The instrument is not intended to be used near active HF
surgical equipment. The customer or user should assure that it is used in such
an environment.
• Always operate, handle, use, and maintain the instrument in compliance with
all applicable laws, rules, regulations and administrative provisions, including,
without limitation, all regulations regarding health and safety at work and, as
appropriate, the safety of devices, as applicable at the location where the
instrument is operated.
• Always use the instrument for its intended purpose only (in accordance with
the product documentation and within its performance limits), and not in any
other manner or for any other purpose.
• Never use the instrument with consumables, parts, or accessories other than
those approved by Miltenyi Biotec, to ensure safe and proper operation of the
instrument. Note: The use of consumables, parts, or accessories not expressly
approved by Miltenyi Biotec could void your warranty and/or invalidate the
authority to operate this instrument under applicable regulations.
• Always follow the maintenance recommendations of Miltenyi Biotec and
appropriate product standards. Note: Maintenance and service of the
instrument must only be performed by authorized local Miltenyi Biotec
Service Provider. Confirm that the instrument is not put into operation unless
and until all periodic maintenance and instrument safety checks have been
successfully performed.

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3
IMPORTANT SAFETY INFORMATION
• Defects should be addressed immediately. If there is any doubt regarding the
proper functioning of the instrument, do not use the instrument and contact
the authorized local Miltenyi Biotec Service Provider or Miltenyi Biotec
Technical Support as soon as possible.
• Never change or modify the instrument except with Miltenyi Biotec’s prior
written approval. Note: Changes or modifications to this instrument not
expressly approved by Miltenyi Biotec could void your warranty and/or
invalidate the operator’s authority to operate the instrument under applicable
regulations.
Risk of death, serious personal injury, and/or property damage, instrument
malfunction, or damage, premature wear and tear, and reduced instrument
lifetime. Failure to comply with the safety information, warnings,
precautions, and instructions in the CliniMACS Workbench User Manual
(and in other safety related publications issued by Miltenyi Biotec for use
with your instrument) could lead to improper or incorrect use, handling or
care of the product and cause a hazard, and could result in death, serious
personal injury, and/or property damage, instrument malfunction, or
damage, premature wear and tear, and reduced instrument lifetime, and
may void the warranty and/or invalidate the authority to operate the
instrument under applicable regulations. Miltenyi Biotec accepts no
liability for consequences arising from failure to comply with the safety
information, warnings, precautions, and instructions provided herein.
If concerned about the safe use of the instrument or require additional safety
information regarding the instrument and its components, contact the
authorized local Miltenyi Biotec Service Provider or Miltenyi Biotec Technical
Support.

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3.1 Safety instructions
In the event of unexpected process abortion or messages on the screen of the
CliniMACS Prodigy that advises the operator to contact technical support,
immediately contact the Miltenyi Biotec Technical Support. If secure operation is
no longer possible, immediately switch off the instrument using the main switch
and contact Miltenyi Biotec Technical Support or an authorized local Miltenyi
Biotec Service Provider.
3.1.1 Usage and installation
Risk of improper operation due to increased electromagnetic emissions or
decreased electromagnetic immunity. The use of consumables,
accessories, transducers, and cables other than those specified or provided
by the manufacturer of this equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation. Electrical equipment requires
special precautions regarding electromagnetic compatibility (EMC) and
must be installed and placed in service according to the EMC information
(see Appendix). Portable and mobile RF communications equipment can
affect medical electrical equipment. Only use the instrument with
accessories, transducers, and/or cables approved by Miltenyi Biotec.
Risk of injury. Installation of the instrument by unauthorized persons can
cause personal injury. The installation of the instrument must be performed by
an authorized local Miltenyi Biotec Service Provider.
The instrument may be used repeatedly. It is not intended for disposal after single
use. Contact the local authority governing electrical power supply, building
construction, maintenance, or safety for more information regarding the
installation of the equipment.
3.1.2 Hazards of electric shock and spread of fire
Electrical instruments pose the risk of an electric shock, electrical short,
and overheating. Electric shock may lead to severe personal injury or
death.
An electrical short and overheating may lead to the spread of fire.

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3
IMPORTANT SAFETY INFORMATION
Electronic equipment may emit sparks that could ignite combustible
vapors or dusts leading to explosion or spread of fire. If flames or smoke
appear, immediately switch off the instrument using the main switch, and
contact an authorized Miltenyi Biotec Service Provider or Miltenyi Biotec
Technical Support.
Risk of electric shock, electrical short, and spread of fire. Electric shock can
lead to severe personal injury or death. The housing of the instrument
reduces the risks of electric shock, electrical short, and spread of fire.
Opening any cover of the instrument interrupts this protective measure.
Do not open, remove or penetrate any cover of the instrument. Only
authorized local Miltenyi Biotec Service Provider may open the instrument
or exchange spare parts. Do not use the instrument in case of visible
damage or if it has been dropped. Contact Miltenyi Biotec Technical
Support.
The CliniMACS Workbench is a Protection Class I instrument and must be
connected to a grounded outlet. Use the instrument only with the specified
voltage given in the technical specifications. Do not connect any electrical device
with more than 500 W to the accessory power outlet of the instrument.
Each power supply line must be protected with a fuse:
• models with low voltage uninterruptible power supply (LV-UPS): Fuse 16 A
• models with high voltage uninterruptible power supply (HV-UPS): Fuse 10 A
3.1.3 Mechanical hazards
Risk of personal injury. Opening of the cover of the gas pressure spring
might cause injury by the moving tilting joint. Do not open, remove or
penetrate any screw or cover of the instrument. Only authorized local
Miltenyi Biotec Service Provider may open the cover of the instrument.
Risk of damage or injury. Damage can occur if the central supplies are
subjected to excessive load or if the ceiling of the facility cannot support
the weight. Do not apply any mechanical load on the central supplies. Only
install the central supplies onto the ceiling if it can support at least 3.5 kg.

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3.1.4 Gas hazards
Risk of gas emission. Escaping CO2and N2can be a potential hazard to the
user, especially during long-lasting incubation procedures. An automated
gas alarm system and monitoring of the gas concentration in the room is
required. An appropriate ventilation of the room must be ensured.
Connection to the gas supply must be performed according to national and
local requirements. Maximum gas concentration in the room may not be
exceeded. A CO2concentration of more than 4.00 ppm (9,100 mg/m3) and
an O2concentration of less than 17 vol.-% of the air is presently regarded
by some authorities as the threshold at which a hazard may be caused. The
safety of the gas supply system is the responsibility of the user. Risk of gas
emission or process failure if excessive pressures are applied. Pressures of
1 bar to max 2.5 bar for each gas may be applied. If the gas connections to
the CliniMACS Prodigy are removed, gas may emit from the system. Do not
remove the gas connections from the CliniMACS Prodigy. In case the gas
connections to the CliniMACS Prodigy need to be removed, remove the
central supplies (which contains gas valves to prevent gas emissions) from
the CliniMACS Workbench first before removing the gas connections to the
CliniMACS Prodigy.
3.1.5 Chemical and biological hazards
Risk of personal injury or death.Depending on the biological material
used, contamination or infection may lead to severe personal injury or
death. Always wear personal safety equipment in accordance with
warnings and precautions, in particular if biohazardous material is or has
been used.
Wear protective gloves, protective clothing, and safety goggles to prevent
contact with skin and eyes. Defective or inadequate safety equipment might
endanger the operator. If hazardous material has been used or spilled, the
operator must take care to thoroughly decontaminate the instrument.
After running the process and prior to decontamination, the instrument should
be treated as a biohazard (see section 4.6 “Cleaning and disinfection” on
page 38). Waste disposal must be in accordance with local regulations.