CliniMACS Prodigy®

User Manual
The CliniMACS System components, including Reagents, Tubing Sets, Instruments, and PBS/EDTA Buffer, are designed,
manufactured and tested under a quality system certified to ISO 13485. In the EU, the CliniMACS System components are
available as CE-marked medical devices for their respective intended use, unless otherwise stated. In the US, the
CliniMACS CD34 Reagent System, including the CliniMACS Plus Instrument, CliniMACS CD34 Reagent, CliniMACS Tubing
Set TS and CliniMACS Tubing Set LS, and the CliniMACS PBS/EDTA Buffer, is FDA approved as a Humanitarian Use Device
(HUD), authorized by U.S. Federal law for use in the treatment of patients with acute myeloid leukemia (AML) in first
complete remission. The effectiveness of the device for this indication has not been demonstrated. All other products of
the CliniMACS Product Line are available for use only under an approved Investigational New Drug (IND) application or
Investigational Device Exemption (IDE). In Australia, the following components of the CliniMACS Prodigy System are
included in the Australian Register of Therapeutic Goods (ARTG) and are therefore approved for supply: CliniMACS
Prodigy, CliniMACS CD34 Reagent, CliniMACS Prodigy Tubing Sets, and CliniMACS PBS/EDTA Buffer. Only those products
which are included in the ARTG may be used in Australia. CliniMACS MicroBeads are for research use only and not for
human therapeutic or diagnostic use.

Unless otherwise specifically indicated, Miltenyi Biotec products and services are for research use only and not for
therapeutic or diagnostic use.

Copyright © 2021 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.

CentriCult, CliniMACS, CliniMACS Prodigy, MACS, the Miltenyi Biotec logo, PepTivator, and TexMACS 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 Prodigy®
User Manual

Issued: 2021-03
38001/05

Miltenyi Biotec B.V. & Co. KG

Friedrich-Ebert-Straße 68
51429 Bergisch Gladbach
Germany

Miltenyi Biotec Technical Support:

+49 2204 8306-3803
[email protected]

www.miltenyibiotec.com
2
Essential information
This user manual provides instructions, warnings, precautions, and other
important information for the use of the CliniMACS Prodigy® as well as warnings
and precautions concerning the handling of biohazardous materials and cellular
starting product. For details on processes run on the instrument, refer to the
CliniMACS Prodigy User Manual for the respective application.

The operation of the CliniMACS Prodigy System must be performed by

trained operators only. Before putting the system into operation, care­
fully read and understand the safety information, warnings, precautions,
and instructions for proper operation of the CliniMACS Prodigy provided
in the instructions for use of the CliniMACS Prodigy System components
(including, without limitation, the safety information in this user manual,
chapter 3 “Important safety information”) and in any safety-related
recommen­dations issued by Miltenyi Biotec. Pay special attention to all
warnings displayed on the instrument 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. 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. Equipment safety may be compromised if the instrument is not
used according to the manufacturer’s instruction.

Retain the instructions for use for future reference. They should be kept
accessible and readily available, together with all other safety and
operating documentation, during the entire life cycle of the instrument
for all personnel responsible for installation, operation, and
maintenance.

3
4
Table of contents

1 Introduction 9
1.1 General information 9
1.2 Service information 10
1.2.1 CliniMACS Prodigy® Information 10
1.2.2 Technical support 10

2 Glossary 11
2.1 Graphical depiction 11
2.2 Glossary of symbols 12
2.2.1 Safety symbols 12
2.2.2 Symbols used for labeling of products 13
2.2.3 Glossary of terms 16

3 Important safety information 27

3.1 Safety instructions for the CliniMACS Prodigy® 30
3.1.1 Usage and installation 30
3.1.2 Electric hazards 31
3.1.3 Strong magnetic field 33
3.1.4 Optical radiation hazards 33
3.1.5 Chemical and biological hazards 34
3.1.6 Mechanical hazards 34
3.1.7 Gas hazards 35
3.1.8 Hot surfaces 35
3.1.9 Servicing and transport 35
3.2 Position of safety symbols 37

5
 Table of contents (continued)

4 The CliniMACS Prodigy® 39

4.1 Regulatory information 39
4.1.1 The CliniMACS Prodigy® within the CliniMACS Prodigy
Cell Separation System 40
4.1.2 The CliniMACS Prodigy® within the CliniMACS Prodigy
Cell & Gene Therapy Manufacturing System 41
4.2 Technical data 42
4.3 Components of the CliniMACS Prodigy® 44
4.3.1 Housing and bag hangers 47
4.3.2 Monitor 48
4.3.3 Peristaltic pump 48
4.3.4 Magnet unit 49
4.3.5 CentriCult™ Unit 49
4.3.6 Gas mix unit 51
4.3.7 Sensors 52
4.3.8 Pinch valves 52
4.3.9 Connector panel 53
4.4 Accessories for the CliniMACS Prodigy® 55
4.4.1 MACS® TubeSealer 55
4.4.2 Bar code reader 55
4.4.3 CliniMACS Prodigy® Supplementary Bag 56
4.4.4 CliniMACS® Electroporator 56
4.4.5 CliniMACS® Formulation Unit 57

6
Table of contents (continued)

4.5 Unpacking and installation 57

4.5.1 Scope of supply 57
4.5.2 Transport 58
4.5.3 Positioning 58
4.6 Cleaning and disinfection 59
4.7 Maintenance 60
4.8 Disposal 60

5 The CliniMACS Prodigy® Software 61

5.1 Touchscreen 61
5.1.1 Use of touchscreen 61
5.1.2 General setup menu 62
5.2 Login, logout, and emergency stop 62
5.2.1 Login 63
5.2.2 Logout 63
5.2.3 Emergency Stop 64
5.3 The graphic user interface 64
5.3.1 Operating controls 64
5.3.2 Menus 70
5.4 Application Services 78
5.4.1 User Management 79
5.5 Alarm management 86

7
 Table of contents (continued)

6 The CliniMACS Prodigy® System 89

6.1 The CliniMACS Prodigy® System components 89
6.2 Additional materials and equipment 90
6.3 Limitation 90
6.4 Warnings and precautions regarding the process 91
6.5 Warnings and precautions regarding the handling of
biohazardous material 92
6.6 Warnings and precautions regarding the cellular starting product 93

7 Troubleshooting 95
7.1 Instrument malfunction or process failure 95
7.2 Instrument cleaning after leakage 95

8 Legal notes 97
8.1 Limited warranty 97
8.2 Trademarks 98

Appendix 99
Guidance and manufacturer’s declaration
on electromagnetic compatibility

8
1
Introduction

Introduction
1
1

1.1 General information

The CliniMACS Prodigy System offers a set of tools that enables high-quality and
standardized cell processing for many different applications. The system is
based on the magnetic cell separation technology (MACS® Technology)
developed by Miltenyi Biotec.

The CliniMACS Prodigy represents the next generation in automated cell and
liquid processing. With its integrated fluid transfer, centrifugation, and magnetic
separation capability, the instrument enables fully automated cell processing
and culture applications, as well as fluid handling. The instrument offers
advanced integrated solutions to streamline cell-processing workflows. It
provides a flexible platform enabling the separation of virtually any cell type, as
well as customized separation protocols that meet specific process require­
ments. The different applications run on the instrument require the use of
specific CliniMACS Prodigy System components as well as additional materials
and equipment, as described in the CliniMACS Prodigy User Manual issued for
the respective application (see also section 6.1).

9
 1.2 Service information
1.2.1 CliniMACS Prodigy® Information

Record the model and serial number located on the back of the CliniMACS
Prodigy® below. Refer to these numbers whenever requesting information
about the instrument or when requesting instrument service.

Reference no. (REF):

Serial no. (SN):

The software version is shown during the start-up phase of the instrument.

1.2.2 Technical support

For information or support, contact Miltenyi Biotec Technical Support:

Miltenyi Biotec B.V. & Co. KG

Friedrich-Ebert-Straße 68
51429 Bergisch Gladbach
Germany

 +49 2204 8306-3803

[email protected]

Visit www.miltenyibiotec.com for local Miltenyi Biotec Technical Support

contact information.

10
2
Glossary

Glossary
2
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 which, if not avoided, could result in

death or serious injury.

Indicates a hazardous situation which, if not avoided, could result in minor or

moderate injury.

Addresses practices or information not related to personal injury but may lead
to property damage.

IMPORTANT
Advises the user of important practices or information not related to personal injury
nor property damage.

11
 2.2 Glossary of symbols
2.2.1 Safety symbols

General warning sign

Warning: Electricity

Warning: Magnetic field

Warning: Optical radiation

Warning: Biological hazard

Warning: High sound pressure level

Warning: Crushing of hands

Warning: Hot surface

12
2.2.2 Symbols used for labeling of products

Medical Device

European conformity approval with ID number 0123 (ID

number of Notified Body: “TÜV SÜD Product Service GmbH,
Munich”).

Glossary
Eurasian Conformity mark

NRTL certification mark: Product meets consensus-based 2

standards of safety, required by the Occupational Safety/
Health Administration (OSHA), determined by the Nationally
Recognized Testing Laboratories (NRTL) TÜV SÜD

Consult instructions for use

Caution

Manufacturer

Date of manufacture

Protective conductor terminal (ground)

Non-ionizing radiation

Separate collection for waste of electrical and electronic

equipment

Fuse

13
 Keep dry

Fragile, handle with care

This way up

Power OFF

Power ON

Installation date

Do not re-use.

Do not use if package is damaged

The packaging is PVC free

Use-by date

Temperature limit

Non-pyrogenic fluid path

Batch code

Part number

Contents of the packaging

14
Catalogue number

Serial number

Unique Device Identification

Glossary
Sterilized using aseptic processing techniques

Sterilized using steam or dry heat

2
Sterilized using irradiation

Non-sterile

Single sterile barrier system

Single sterile barrier system with protective packaging outside

Phone

Fax

E-Mail

Website

15
 2.2.3 Glossary of terms

Alarm connector Relay circuit connector for the connection of the

instrument to an external alarm system

Antigen Bag Bag containing antigen, part of the CliniMACS

Prodigy TS 500

Apheresis A method of collecting blood in which the whole

blood is withdrawn, a desired component selected
and retained, and the remainder of the blood
returned to the donor

Application Bag Bag for cellular starting product, part of CliniMACS

Prodigy Tubing Sets

AUX 3 pin connector Connector for compatible external devices, currently

(for CliniMACS Prodigy non-functional
manufactured until July 2020)

AUX 5 pin connector See TubeSealer port

Bag compartment Compartment of the CliniMACS Prodigy for the

storage of bags during instrument operation

Bag hanger Component of the CliniMACS Prodigy on which

elements of the CliniMACS Prodigy Tubing Sets, such
as buffer bags, application bags, or vials are
mounted

Bar code Machine-readable representation of data, e.g., part

number, batch code, or use-by date, indicated on
required materials

Bar code reader The bar code reader serves as a data input device to
scan bar codes printed on, e.g., CliniMACS Materials,
needed for process execution with the CliniMACS
Prodigy System.

Bone marrow aspirate Sample of bone marrow taken by insertion of a

needle through the bone drawn into a syringe

CAN Controller Area Network

16 CAN connector Connector used for service purposes only

Cellular starting Cell-containing product used as starting material for
product the CliniMACS Prodigy Applications, e.g.,
leukapheresis harvest, PBMCs, or bone marrow

CentriCult™ Unit The CentriCult Unit, as a part of the CliniMACS

Prodigy, comprises a cell processing compartment
featuring the following components: Layer
Detection Camera, microscope camera, heat
exchange unit, chamber lock adapter, and the lid of
the unit. This compartment can be temperature and

Glossary
atmosphere controlled for centrifugation,
incubation, and cell cultivation.

CentriCult Unit lid Protection cover locking the CentriCult Unit 2

Centrifugation sensor Part of the CentriCult Unit to control the
centrifugation speed

Chamber Compartment for fractionation, washing, and

labeling by centrifugation and for cultivation of cells,
part of the CliniMACS Prodigy Tubing Sets

Chamber drive unit Unit which drives the chamber within the CentriCult
Unit

Chamber lock adapter The chamber lock adapter holds the chamber of the
tubing set and connects it to the chamber drive unit

Channel clip Blue clip holding the tubing outside the CentriCult
Unit in position

Check valve Check valves are two-port valves, meaning they

have two openings in the body, one for fluid to enter
and the other for fluid to leave. An important
concept in check valves is the cracking pressure
which is the minimum upstream pressure at which
the valve will operate.

Cleaning solution Aqua bidest for injection use. The cleaning solution
is used for cleaning the inner tubing and chamber of
the tubing set during specific cleaning process steps.
The cleaning solution is not part of the CliniMACS
Prodigy System.
17
 Cleaning solution bag Bag containing the cleaning solution. The cleaning
solution bag is not part of the CliniMACS Prodigy
Tubing Sets.

CliniMACS PBS/EDTA Buffer used for cell preparation and cell separation
Buffer with the CliniMACS System: PBS (phosphate-
buffered saline), supplemented with 1 mM EDTA, pH
7.2. Before use, CliniMACS PBS/EDTA Buffer must be
supplemented with pharmaceutical-grade HSA to a
final concentration of 0.5% (weight/volume, i.e. 5 g
HSA per liter buffer). HSA-supplemented buffer is
called process buffer.

CliniMACS The CliniMACS Electroporator is a fully automatic

Electroporator instrument for the electroporation of eukaryotic
cells in combination with the CliniMACS Prodigy.
After electroporation, cells are further processed by
the CliniMACS Prodigy.

CliniMACS Buffer used for the electroporation of cells with the

Electroporation Buffer CliniMACS Electroporator

CliniMACS The CliniMACS Formulation Unit is an instrument

Formulation Unit accessory for the automated final formulation and
sampling of eukaryotic cells in combination with the
CliniMACS Prodigy. The CliniMACS Formulation Unit
enables the user to take cell samples during or after
processing by the CliniMACS Prodigy.

CliniMACS Prodigy The CliniMACS Prodigy is an instrument for

automated cell processing. This instrument offers
integrated solutions for cell processing workflows:
from cell separation through cell culture to
formulation of the final product.

CliniMACS Prodigy The CliniMACS Prodigy Supplementary Bag is

Supplementary Bag intended to help reduce the user's contact to
accidently emitted, potentially infectious sample
material out of the CliniMACS Prodigy Tubing Set.

18
CliniMACS Prodigy Set of tubing, connectors, columns (as applicable to
Tubing Set the tubing set), centrifugation chamber, pump
tubing, and bags through which the cell suspension
is processed. The different tubing sets are designed
for the specific needs of the respective application.

EDTA Ethylene-diamine-tetra-acetic acid

Electroporation The electroporation cuvette is part of the CliniMACS

cuvette Prodigy EP-4 and CliniMACS Prodigy EP-2 and placed

Glossary
in the holder of the Electroporation Unit. Cells and
nucleic acids, proteins, or other small molecules are
filled into the electroporation cuvette and a strong
electrical impulse is applied on the cells. 2
Electroporation unit The Electroporation Unit includes a holder for the
electroporation cuvette and applies an electrical
impulse onto the cuvette.

Elution buffer Solution for eluting cells into the Target Cell Bag and
Non-Target Cell Bag

Elution buffer bag Bag containing the elution buffer, part of the
CliniMACS Prodigy Tubing Sets

Filtration Bag Bag for filtration of cellular product which is labeled

with depletion reagent before magnetic cell separa­
tion, part of specific CliniMACS Prodigy Tubing Sets.

×g Multiples of the Earth’s gravitational acceleration

Gas inlet connector Three gas inlet connectors at the rear side of the
instrument for the connection of external gas
supplies

Gas mix unit The gas mix unit inside the CliniMACS Prodigy is
used to prepare a mixture of up to three different
gases for cell culture purpose. Only CO2, compressed
air, and optionally N2 may be used with the
CliniMACS Prodigy.

19
 Gas outlet connector Single outlet connector at the front of the
instrument for connection of the gas mix unit to the
tubing set to allow setting of the atmosphere within
the cultivation chamber

Grounding screw Part of the connector panel at the rear side of the
CliniMACS Electroporator

Guide pin Part of the peristaltic pump to hold the pump tubing
in place

Heat Exchange Part of specific CliniMACS Prodigy Tubing Sets which

Cartridge (HEC) allows temperature control of fluids within the
tubing set

Heat exchange unit Part of the CentriCult Unit ensuring constant

temperatures within the unit

Hematopoietic Progenitor cells of lymphoid, myeloid, and erythroid

progenitor cells lineage

Housing Cabinet of the CliniMACS Prodigy including bag

hangers and a bag tray. A touchscreen is connected
to the housing.

HSA Human serum albumin. Pharmaceutical-grade HSA,

approved in your country, is necessary as a buffer
supplement when used with the CliniMACS Prodigy
System and is not supplied as part of the CliniMACS
System.

Infusion solution Buffer or media in which cells are finally formulated

after cell processing. The composition of this
solution is dependent on further down-stream use
of the cell product and can be chosen individually by
the operator. The infusion solution is not part of the
CliniMACS Prodigy System.

Infusion solution bag Bag containing the infusion solution. The infusion
solution bag is not part of the CliniMACS Prodigy
Tubing Sets.

20
Inlet tube Closed tubing, which allows sterile welding of
additional bags, accessories etc., part of specific
CliniMACS Prodigy Tubing Sets.

Intermediate Storage Bag Bag for intermediate storage of labeled cells, part of
specific CliniMACS Prodigy Tubing Sets

Labeling Binding of cells by magnetic labeling reagent, e.g.,

CliniMACS CD34 Reagent to CD34 positive cells

Glossary
Layer Detection Camera system using proprietary technology for the
Camera detection of the different interlayers during
centrifugation, allowing controlled aspiration of cells
or fluids, part of the CentriCult Unit 2
Leukapheresis Apheresis collecting leukocytes

Liquid sensor The CliniMACS Prodigy is equipped with four liquid

sensors that monitor the flow of liquid in the tubing
set based on an ultrasonic principle. It allows
detection of air bubbles.

Luer connector Screw coupling, part of the CliniMACS Prodigy

Tubing Sets

MACS TubeSealer Heat sealer used for sealing PVC and EVA tubes of
the CliniMACS Prodigy Tubing Sets installed on the
CliniMACS Prodigy

Magnet unit The magnet unit is used to separate magnetically

labeled cells from non-labeled cells. It includes a
movable, strong permanent magnet and a column
holder for the separation column in which the
magnetically labeled cells are retained.

Magnetic antibody A super-paramagnetically labeled antibody

Medium bag Bag containing medium (e.g. TexMACS™ Medium).

The medium bag is not part of the CliniMACS
Prodigy Tubing Sets.

Microscope camera Optical unit for microscopic examination of cells

cultured within the chamber, part of the CentriCult
Unit
21
 Monoclonal antibody A single type of antibody that is directed against a
specific epitope (antigen, antigenic determinant)
and is produced by a single clone of B cells or a
single hybridoma cell line, which is formed by the
fusion of a lymphocyte cell with a myeloma cell.

Non-Target Cell Bag Bag containing the non-target cell fraction, part of
specific CliniMACS Prodigy Tubing Sets

Non-Target Cell Bag Bag containing labeled cells (non-target cell fraction)
Depletion after depletion procedure, part of specific CliniMACS
Prodigy Tubing Sets

PepTivator® PepTivators are pools of lyophilized peptides.

PepTivator peptide pools consist of mainly 15mer
peptides with eleven amino acids overlap, covering
the whole sequence of the protein antigen.

Peristaltic pump Instrument part used to control the flow rate of fluid
within the tubing set

Pinch valve Part of the CliniMACS Prodigy: 24 magnetic valves

are used to fix the CliniMACS Prodigy Tubing Set
onto the instrument and to ensure controlled flow
pathways within the tubing set throughout the
procedure

Plasma transfer set Connector set with two couplers to connect two
bags. A plasma transfer set may be required for
some processes. The plasma transfer set is not part
of the CliniMACS Prodigy Tubing Sets.

Power-CAN connector Connector for external devices with higher power

requirements (such as the CliniMACS Electroporator)

Pre-column Column which serves as a filter to trap cells that

interact non-specifically with the column matrix,
part of specific CliniMACS Prodigy Tubing Sets

Pre-column holder Holder connected to bag hanger to hold the

pre-column of the tubing set in place, part of the
CliniMACS Prodigy

22
Pressure sensor Integral part of the peristaltic pump that monitors
the pressure within the tubing set to allow for
detection of leakages or clogging of the tubing set

Priming Step prior to cell separation in which buffer or

medium is flushed through the tubing set

Priming Bag Bag containing buffer from priming step, part of

specific CliniMACS Prodigy Tubing Sets

Glossary
Process Software program designed for cell processing and
culture applications. The operator is able to choose
from a menu of processes depending on the
intended procedure. 2
Process buffer CliniMACS PBS/EDTA Buffer supplemented with HSA
to a final concentration of 0.5% (w/v)

Process buffer bag Bag containing CliniMACS PBS/EDTA Buffer

supplemented with HSA to a final concentration of
0.5% (w/v)

Process medium Medium for cultivation and processing of cells within

the tubing set

Pump safety switch Sensor that prevents pump operation when the
pump door is open, part of the CliniMACS Prodigy

QC Bag Bag containing automatically collected in-process

QC-samples, part of specific CliniMACS Prodigy
Tubing Sets

RBC Red blood cells

Reapplication Bag Bag for enriched cells prior to cultivation, part of the
CliniMACS Prodigy Tubing Sets

Reservoir Bag Bag containing the elution buffer, part of specific

CliniMACS Prodigy Tubing Sets

Retaining ring Plastic ring at each end of the pump tubing that
enables the pump tubing to remain in its proper
location, part of the CliniMACS Prodigy Tubing Sets
23
 rpm Revolutions per minute

Safety valve Safety valve of the gas mix unit, positioned at the
rear side of the instrument

Separation column Column in which magnetically labeled cells are

retained when exposed to the magnetic field, part of
the CliniMACS Prodigy Tubing Sets

Separation column Molded guides in the magnet unit that holds the
holder separation column in place

Separation reagent Reagent for magnetic labeling of cells, e.g.,

CliniMACS CD34 Reagent

Signal lamp LED signal lamp positioned at the top of bag

hanger A to provide optical signals about the status
of the instrument in operation

Supplementary Bag Instrument part underneath the CentriCult Unit for

compartment the storage of the CliniMACS Prodigy Supplementary
Bag

Target Cell Bag Bag containing the target cell fraction, part of
specific CliniMACS Prodigy Tubing Sets

Test Cuvette Adapter The Test Cuvette Adapter (TCA) serves for testing
electroporation parameters in a small scale with
electroporation cuvettes used in manual
electroporation devices.

Touchscreen TFT LCD type with touchscreen functionality as part

of the CliniMACS Prodigy to guide the operator
through the setup procedure and allow monitoring
of automatic instrument operations. Located in the
touchscreen are the central control board and the
data storage unit.

Transfer bag Bag with a tubing and a spike at the end. The
transfer bag is not part of the CliniMACS Prodigy
Tubing Sets.

TubeSealer port Connector for the MACS TubeSealer

24
Tubing duct Instrument part between the housing and the lid of
the CentriCult Unit serving as save passageways for
the tubing of the tubing set from inside the
CentriCult Unit to the outside of the unit

USB Universal serial bus

USB ports Standard USB ports to allow easy data transfer

User program Software program defining a specific sequence of

Glossary
cell processing steps, e.g., centrifugation, liquid
transfer, or controlled incubation.

Vial adapter Adapter on the CliniMACS Prodigy Tubing Sets to 2

connect the vial (e.g. CliniMACS Reagent vial)

Vial holder Part of the bag hanger assembly to hold a vial in

place

Waste Bag Bag containing discarded liquids during operation of

the CliniMACS Prodigy, part of specific CliniMACS
Prodigy Tubing Sets

WBC White blood cells

25
26
3
Important safety information

Important safety information

The operation of the CliniMACS Prodigy System must be performed by
3
trained operators only. Before putting the system into operation, care­
fully read and understand the safety information, warnings, precautions,
and instructions for proper operation of the CliniMACS Prodigy provided
in the instructions for use of the CliniMACS Prodigy System components
(including, without limitation, the safety information described in this
chapter) and in any safety-related recommen­dations issued by Miltenyi
Biotec. Pay special attention to all warnings displayed on the instrument
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, precau­
tions, and instructions are observed. Failure to follow the safety in­for­
mation, warnings, precautions, and instructions contained in the instruc­
tions for use could result in instrument malfunction, property damage,
personal injury, and/or death. Equipment safety may be compromised if
the instrument is not used according to the manufacturer’s instruction.

Retain the instructions for use for future reference. They should be kept
accessible and readily available, together with all other safety and
operating documentation, during the entire life cycle of the instrument
for all personnel responsible for installation, operation, and maintenance.

27
 Hazards to users, instrument damage, and/or malfunction, unpredictable
results, premature wear and tear, and/or reduced life time of the
instrument if the following safety information, warnings, precautions,
and instructions are not observed 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 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 trained personnel familiar with
the construction, operation, and hazards involved with the instrument. The
instrument is intended for 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 medical devices, as applicable, at the
location where the instrument is operated.

• Always use the instrument for its designated purpose (in accordance with
the product documentation and within its performance limits), and not in
any other manner or for any other purpose.

• Safety and performance of the instrument may be compromised. Never use

the instrument with consumables, accessories, transducers, and/or cables
other than those approved by Miltenyi Biotec to ensure safe and proper
operation of the instrument.

• Note: The use of consumables, accessories, transducers, and/or cables not

expressly approved by Miltenyi Biotec could void the warranty and/or
invalidate the authority to operate this instrument under applicable
regulations.

28
• Always follow the maintenance recommendations of Miltenyi Biotec and
appropriate product standards. Note: Installation, maintenance, and service
of the instrument must only be performed by authorized local Miltenyi
Biotec Service Provider. Ensure that the instrument is not put into operation
unless and until all initial and periodic maintenance and instrument safety

Important safety information

checks have been successfully performed.

• 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 the instrument not
expressly approved by Miltenyi Biotec could void the warranty and/or
invalidate the operator’s authority to operate the instrument under
applicable regulations.
3

Risk of death, serious personal injury, and/or property damage,

instrument malfunction, or damage, premature wear and tear, and
reduced instrument life time. Failure to comply with the safety
information, warnings, precautions, and instructions in the user manuals
(and in other safety related publications issued by Miltenyi Biotec for use
with the 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 life time, and
may void the warranty and/or invalidate the authority to operate the
instrument under applicable regulations. Always follow the safety
information, warnings, precautions, and instructions in the user manuals
(and in other safety related publications issued by Miltenyi Biotec for use
with the instrument). 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 if additional safety

information regarding the CliniMACS Prodigy System is required, contact the
authorized local Miltenyi Biotec Service Provider or Miltenyi Biotec Technical
Support.

29
 3.1 Safety instructions for the CliniMACS Prodigy®
In the event of an unexpected process abortion or messages on the screen that
advise the operator to contact technical support, immediately contact the
Miltenyi Biotec Technical Support. If secure operation is no longer possible,
immediately switch off and unplug the instrument from the power outlet, and
contact Miltenyi Biotec Technical Support or an authorized local Miltenyi Biotec
Service Provider.

3.1.1 Usage and installation

Risk of process failure. If alarm signals are not recognized and the required
actions are not executed or confirmed there is the risk of process failure.
Confirm that optical and acoustical alarm signals can be recognized by the
operator at any time during the process.

Risk of improper operation due to increased electromagnetic emission or

decreased electromagnetic immunity. The use of consumables,
accessories, and cables other than those specified or provided by the
manufacturer of this equipment could result in increased
electromagnetic emission or decreased electromagnetic immunity of this
equipment and result in improper operation. Medical 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. Installation of the CliniMACS Prodigy must
only be performed by an authorized local Miltenyi Biotec Service
Provider.

The CliniMACS Prodigy 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.

Suitability of the target cells for clinical application may be compromised.

The target cells must be analyzed, otherwise the suitability for clinical
application may be compromised. Examine the target cells regarding quality
and quantity in view of their intended use.
30
3.1.2 Electric hazards

Electrical instruments pose the risk of an electric shock, electric short

circuit, and overheating. Electric shock may lead to severe personal injury
or death. Do not use the instrument in case of visible damage or if it has

Important safety information

been dropped. Contact Miltenyi Technical Support.

An electrical short and overheating may lead to the spread of fire.

The CliniMACS Prodigy is a Protection Class I device and may only be plugged
into an outlet with a grounded connection.

Electronic equipment may emit sparks that could ignite combustible

vapors or dusts leading to explosion or spread of fire.

Risk of electric shock, electrical short, and spread of fire. The housing of
3
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 remove or penetrate any cover of the
instrument. Only an authorized local Miltenyi Biotec Service Provider may
open the instrument or exchange spare parts.

Risk of electric shock or damage to the instrument. Risk of electric shock

or damage to the instrument if the instrument is cleaned with excessive
amount of cleaning or while switched on. Only clean the instrument when
it is switched off and the power cord is unplugged. Avoid ingress of any
liquid into the valves and into the liquid sensor. Do not use an excessive
amount of cleaning or disinfection agents to avoid spilling into the gas
outlet connector. After cleaning, dry all excess liquid from the valves,
pump head, gas outlet connector etc.

If flames or smoke appear, immediately switch off the instrument, unplug

it from the electrical outlet, and contact an authorized local Miltenyi
Biotec Service Provider or Miltenyi Biotec Technical Support.

The instrument is intended for indoor use only. Water ingress may lead to
an electrical short and the risk of electric shock or spread of fire. Do not
use the instrument in a wet or damp location or if it has been exposed to
moisture. Avoid high humidity or condensation and protect the
instrument from contact with water. Special care must be taken while
handling fluids. Clean spillages immediately. Do not allow fluids to enter
the interior of the instrument. Avoid ingress of any liquid into the valves.
Do not operate the instrument if liquids have spilled into the instrument.
31
 Fluid containers must be handled with caution when in the area of the
instrument. After moving the instrument from a cold environment, such
as a cold room at +4 °C (+39 °F), to room temperature, condensing liquid
droplets may form inside the instrument. It is necessary to wait for the
instrument to dehumidify before operating the instrument. Unplug the
instrument from the power outlet before cleaning. Do not use liquid or
aerosol cleaning agents; always use a damp cloth.

Risk of overheating. Risk of overheating in case of reduced air circulation. Do

not place the instrument with the back side directly against the wall. Keep at
least 14 cm distance to allow free air circulation. Allow sufficient space
around the ventilation slots at the rear and underneath the instrument. Take
into consideration that the instrument requires adequate air circulation for
heat exchange and cooling. Read the chapter “Important safety information”
to avoid the risk of overheating.

Ambient air temperature may not be adequate to cool the instrument to

acceptable operating temperatures without adequate circulation. Confirm
the room in which the instrument is operated has adequate air circulation.
The instrument should not be placed next to radiators, heat registers, stoves,
or other pieces of equipment (including amplifiers) that produce heat.
Prevent direct exposure of the instrument to sunlight. Slots and openings of
the instrument are provided for ventilation and should never be blocked or
covered, as these protect the instrument from overheating. Do not place the
instrument within a built-in apparatus or a confined space, such as a shelf
rack, unless the apparatus has been specifically designed to accommodate
the instrument, proper ventilation is provided, and the mounting
instructions for the instrument have been followed.

Assure that the main switch, as well as the outlet for the power cord are easily
accessible and located as close to the operator of the instrument as possible. If it
is necessary to disconnect the power supply, unplug the cord from the power
outlet.

The instrument is equipped with a three-wire electrical grounding-type plug

that has a third pin for grounding. This plug only fits into a grounded power
outlet. This is a safety feature. Do not try to insert the plug into a non-grounded
power outlet. If the plug cannot be inserted into the outlet, contact the local
electrician to replace the outlet.

The instrument should only be operated from a power source indicated on the
product’s electrical ratings label. For questions about the type of power source
to use, contact the authorized local Miltenyi Biotec Service Provider. Do not use
extension cords or power strips. Do not overload an electrical outlet.
32
Risk of termination of the separation process. Based on technical limitations
of the internal power supply voltage of the instrument, interruptions on
power supply input lines for longer than 10 ms may lead to termination of
the separation process (power failure). The separation process cannot be

Important safety information

resumed after a power failure. It is recommended that the instrument is
powered from an uninterruptible power supply or a battery that starts
within 10 ms.

3.1.3 Strong magnetic field

Risk of severe personal injury for persons carrying pacemakers, brain

shunts, or electronic medical implants. The CliniMACS Prodigy is
equipped with an extremely strong permanent magnet generating a
strong magnetic field. There is a risk of severe personal injury for persons
3
carrying pacemakers, brain shunts, or electronic medical implants.
Always maintain a distance of at least 30 cm from the magnet cover. Keep
any magnetic information carriers (such as credit cards or magnetic
tapes), electronic equipment (such as hearing aids, measuring and
control instruments, computers, and watches), and magnetizable tools
and objects at a distance of at least 30 cm from the magnet cover. These
items may be affected or damaged by the magnetic field.

3.1.4 Optical radiation hazards

The CliniMACS Prodigy is equipped with a light emitting diode (LED) for the
signal lamp at the left bag hanger (position A).

The optical radiation emitted from the LED may be harmful to the eyes at
close viewing distances. Light emission is especially powerful when bag
hanger A is disassembled. Do not disassemble the bag hanger A while the
instrument is switched on.

33
 3.1.5 Chemical and biological hazards

Risk of severe 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, take care
to thoroughly decontaminate the instrument.

After running the sample and prior to decontamination, the CliniMACS Prodigy
should be treated as a biohazard (see section 4.6). Waste disposal must be in
accordance with local regulations.

3.1.6 Mechanical hazards

Risk of internal damage. Movement or vibration may affect the instrument.

Do not place the instrument next to equipment that vibrates or can cause
the instrument to move. Imbalance during centrifugation can lead to
substantial vibrations. Shut down the instrument when substantially strong
vibrations occur. Contact Miltenyi Biotec Technical Support for assistance.

Keep away from all moving parts. Do not lean on the CliniMACS Prodigy or the
CentriCult Unit.

34
3.1.7 Gas hazards

Gas hazard. Escaping CO2 and N2 can be a potential hazard to the user,
especially during long-lasting incubation procedures. An automated gas

Important safety information

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 CO2 concentration of more than 4.00 ppm (9,100 mg/m3)
and an O2 concentration 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.

3.1.8 Hot surfaces 3

Risk of burns. The surface of the heat exchange unit and the heat exchange
cartridge (HEC) may become hot enough to cause burns if touched. A high
temperature may also occur at the heat sink on the back of the instrument.
Do not touch the heat exchange unit, the HEC, the heat sink on the back of
the instrument while the instrument is in operation.

3.1.9 Servicing and transport

Hazards to users, unpredictable results, instrument malfunction or

damage, premature wear and reduced life time of the instrument.
Improper or incorrect servicing or repair of the instrument can cause
hazards to users, lead to unpredictable results, instrument malfunction
or damage, premature wear and reduced life time of the instrument, and
may void the warranty. Unless otherwise specifically noted in this user
manual, do not service the CliniMACS Prodigy. Service and repair may
only be performed by authorized local Miltenyi Biotec Service Provider.

Using unauthorized replacement or spare parts can cause malfunction of the

instrument and impair results. Miltenyi Biotec does not honor any warranty or
accept any responsibility for instrument failure or damages resulting from the
use of inappropriate replacement or spare parts. After completing any services
or repairs, authorized local Miltenyi Biotec Service Providers perform all required
safety checks to ensure that the instrument is fully functional.
35
 For information about Miltenyi Biotec’s instrument service and support
arrangements, contact the authorized local Miltenyi Biotec Service Provider or
Miltenyi Biotec Technical Support.

Risk of internal damage. Internal damage can occur if the instrument is

subjected to excessive vibration or is dropped. The instrument should be
transported with care in packaging specified by Miltenyi Biotec. Do not lift
the instrument by the touchscreen, the CentriCult Unit, peristaltic pump unit,
or the magnet unit.

Ergonomic hazard. If the instrument is lifted by one person, there is the risk
of personal injury. The transport should be performed by at least two people
according to the instructions in section 4.5.2. The instrument should be lifted
in an upright position under each of the four corners at the base of the
instrument.

Before transportation, the instrument must be switched off and disconnected

from the power supply. All bag hangers and disposables should be removed
from the instrument.

Chemical and biological hazard. Risk of chemical or biological hazards

due to contaminated surfaces. If the instrument needs to be shipped back
to the manufacturer for service, decontaminate the instrument from any
hazardous material prior to shipment. For details regarding proper
decontamination refer to the instructions in section 4.6.

36
3.2 Position of safety symbols
Notice the positions of the safety symbols (see Figure 3.1 and Figure 3.2) on the
CliniMACS Prodigy and keep them in an easily readable state. The safety labels
must be kept clean and legible.

Important safety information

M
 agnetic field

G
 eneral warning sign
1 2 3 4 5 6 7 8 9 10

23 24 11
12

13
H
 ot surface

3
16 14 15
17
18
19 20 21 22

Figure 3.1: Position of safety symbols on the front of the instrument (exemplary SN 491 or higher)

G
 eneral warning sign

H
 ot surface

G
 eneral warning sign

Figure 3.2: Position of safety symbols on the rear of the instrument (exemplary SN 491 or higher)

37
38
4
The CliniMACS Prodigy®

THE CLINIMACS PRODIGY

4.1 Regulatory information
Based on the respective intended use, the CliniMACS Prodigy® can be used in
various application systems that differ in terms of their regulatory classification: 4
1. The CliniMACS Prodigy Cell Separation System is intended to separate
human cells.

 CliniMACS Prodigy is a Medical Device in Europe if used as part of the

CliniMACS Prodigy Cell Separation System.

2. The CliniMACS Prodigy Cell & Gene Therapy Manufacturing System is

intended for genetic and/or other substantial manipulation (like
proliferation, differentiation) steps of human cells.

 CliniMACS Prodigy is no Medical Device in Europe if used as part of

the CliniMACS Prodigy Cell & Gene Therapy Manufacturing System.

For regulatory status in countries outside Europe, contact the authorized local
Miltenyi Biotec Service Provider.

39
 4.1.1 The CliniMACS Prodigy® within the CliniMACS Prodigy
Cell Separation System
Intended purpose
The CliniMACS Prodigy® Cell Separation System, consisting of the components
CliniMACS Prodigy, CliniMACS Reagent(s), CliniMACS Prodigy Tubing Set,
CliniMACS PBS/EDTA Buffer, and further accessories, which must be used in
combination, is intended for the in vitro separation of specific human cells for
clinical applications.

The CliniMACS Prodigy is intended to operate the components of the CliniMACS

Prodigy Cell Separation System to enable the in vitro separation of specific
human cells for clinical applications.

For the operation of the CliniMACS Prodigy Cell Separation System, only the
components stated as CE-marked medical devices and accessories defined in
the CliniMACS Prodigy User Manual for the respective applications must be used
with and connected to the instrument.

The instrument conforms to the Medical Device Regulation MDR (EU) 2017/745:

The instrument complies with the following standards:

• IEC/EN 61010-1
• CAN/CSA-C22.2 No. 61010-1
• K 61010-1
• IEC/EN 61010-2-10
• CAN/CSA-C22.2 No. 61010-2-10
• IEC/EN 61010-2-20
• CAN/CSA-C22.2 No. 61010-2-20
• IEC 60601-1-2

For the applied standard version, refer to the respective Certificate of

Conformance.

The instrument is in conformity with Directive 2011/65/EU of the European

Parliament and of the Council of 8 June 2011 on the restriction of the use of
certain hazardous substances in electrical and electronic equipment.

40
IMPORTANT
Any serious incident that has occurred in relation to this product should be reported
to Miltenyi Biotec B.V. & Co. KG – using the contact information provided – and the
competent authority of the member state in which the user of this product is
established.

4.1.2 The CliniMACS Prodigy® within the CliniMACS Prodigy

Cell & Gene Therapy Manufacturing System
Intended use

THE CLINIMACS PRODIGY

The CliniMACS Prodigy® Cell & Gene Therapy Manufacturing System is intended
for ex vivo genetic and/or substantial manipulation of human cells or
manufacture of an Advanced Therapy Medicinal Product (ATMP) for clinical
applications.

Rationale
During applications of the CliniMACS Prodigy Cell & Gene Therapy 4
Manufacturing System, the cells are subjected to modification (genetic and/or
substantial manipulation; Cell separation, concentration, or purification are not
considered as substantial manipulation according to Regulation (EC)
No. 1394/2007) by pharmacological, immunological, or metabolic means as the
principal intended action. The resulting cells are therefore considered as
Advanced Therapy Medicinal Product (ATMP) in Europe.

As a consequence, the components of this CliniMACS Prodigy Cell & Gene

Therapy Manufacturing System cannot be classified as Medical Devices. Instead,
the CliniMACS Prodigy Cell & Gene Therapy Manufacturing System is considered
as manufacturing system for medicinal products. Therefore, European GMP
guidelines (EudraLex Vol. 4) have to be followed when using the CliniMACS
Prodigy Cell & Gene Therapy Manufacturing System for manufacture of
medicinal products in Europe.

For operating the CliniMACS Prodigy Cell & Gene Therapy Manufacturing
System, only the stated products defined in the respective applications must be
used with and connected to the CliniMACS Prodigy.

41
 4.2 Technical data

Safety and performance of the CliniMACS Prodigy may be compromised.

Safety and performance of the instrument may be compromised if the
CliniMACS Prodigy is used outside its specifications. Do not use the
instrument outside its specifications.

The technical data of the instrument are listed in Table 4.1.

Technical data
Model CliniMACS Prodigy (REF 200-075-301)

Dimensions Width: 7
 3.2 cm (plus approx. 20 cm for holder of heat sealer
and bar code reader)
Depth: 40 cm housing
Height: 48 cm housing (plus 42–60 cm for bag hangers)

Weight Approx. 70 kg
(excluding weight of attached consumables and accessories)

Input voltage 100–240 V AC (Single phase alternating current)

Power 810 VA
consumption

Frequency 50/60 Hz

Fuses 2× T10AH250V

Pump speed 2–400 mL/min

Atmosphere Gas mix unit for CO2, compressed air, and optionally N2,
control min. pressure: 1.0 bar, max. pressure: 2.5 bar

Temperature +4 °C to +38 °C (+39 °F to +100 °F)

control

Centrifugation Max. 2.500 rpm (400×g)

Microscope Max. magnification 400-fold

camera

Operation Temperature: +15 °C to +25 °C (+59 °F to +77 °F)

conditions Humidity: 10% to 75% relative humidity, non-condensing
Altitude: <2,000 meters above sea level

Storage Room temperature

conditions Avoid condensing conditions.
Table 4.1: Technical data of the CliniMACS Prodigy

42
The instrument including accessories complies to the EMC standard
IEC 60601-1-2. For details refer to the appendix of this user manual. It is a
Protection Class I instrument and must be plugged into a grounded power
outlet. Conditions of operation: Supply voltage fluctuations up to ±10% of the
nominal voltage. Transient over-voltages present on the mains supply:
Category II. The instrument is suitable for rated pollution degree 2.

The instrument has been tested and found to comply with the limits for a
Class A digital device, pursuant to Part 15 of the FCC Rules. Note: The emissions
characteristics of this instrument make it suitable for use in industrial areas and

THE CLINIMACS PRODIGY

hospitals (CISPR 11 class A). If it is used in a residential environment (for which
CISPR 11 class B is normally required), this instrument might not offer adequate
protection to radio-frequency communication services. The user might need to
take mitigation measures, such as relocating or reorienting the instrument. If
this instrument does cause harmful interference to radio or television reception,
which can be determined by turning the instrument off and on, the user is
encouraged to try to correct the interference by one or more of the following
measures:
4
• Reorient or relocate the receiving antenna,
• Increase the distance between the instrument and the receiver,
• Connect the instrument to an outlet on a circuit different from that to which
the receiver is connected,
• Consult the dealer or an experienced radio/TV technician for help.

Changes or modifications of the instrument, unless expressly approved by

Miltenyi Biotec, may void the authority to operate the instrument pursuant to
FCC 47 CFR.

43
 4.3 Components of the CliniMACS Prodigy®
The following section describes the components of the CliniMACS Prodigy®.
Table 4.2 gives an overview of components included per instrument serial
number. Repairs or hardware updates made by the authorized local Miltenyi
Biotec Service Provider may lead to a modified state of construction and
retrofitting of the instrument.

Serial number 001-490 491-xxx

Housing with
• Bag hangers 6 6
• Bag hanger hooks 2 / Optional: 5 5
• Lower hook bag hanger A – / 
• Bag compartment(s)  

Monitor
• TFT Touchscreen 8.4’’ 10.1’’
• USB port on monitor 1 2
• Touchscreen operated with blunt items  –
• Touchscreen operated with fingers/gloves  

Peristaltic pump  

Magnet unit  

CentriCult Unit
• with Layer Detection Camera and  
Microscope camera
• Drive shaft ready for CentriCult Chamber 800/1 – 

Gas mix unit

with gas outlet connector, gas inlet connectors,  
and safety valve

Sensors
• Liquid sensors 4 4
• Pressure sensors 2 2

Pinch valves 24 24

Connector panel  

Single pre-column holder  –

Dual pre-column holder – 

Caption:  Standard  Optional – Not available

Table 4.2: Configuration differences of the instrument

44
The front view of the instrument is shown in Figure 4.1.

Bag Gas Liquid Monitor with touchscreen

hanger outlet sensor (LS)
Magnet unit

THE CLINIMACS PRODIGY

USB ports
1 2 3 4 5 6 7 8 9 10

23 24 LS1 11 LS2
12 Bar code
reader
LS4 13
(accessory) 4
16 14 15
17
18
LS3 19 20 21 22

Peristaltic Pinch
pump valve
MACS
CentriCult Supplementary Bag Bag TubeSealer
Unit compartment compartment (accessory)

Figure 4.1: Front view of the instrument (exemplary SN 491 or higher)

45
 The rear view of the instrument is shown in Figure 4.2.

Main Gas inlets and safety valve

power

Instrument UDI Connector Protective

label label panel earthing

Figure 4.2: Rear view of the instrument (exemplary SN 491 or higher)

46
4.3.1 Housing and bag hangers

In addition to its common function as a cabinet, the housing also includes a set
of bag hangers and a bag compartment that holds bags for fluids (e.g. waste
bags). The touchscreen is also connected to the housing.

The CliniMACS Prodigy is equipped with six bag hangers labeled A to F at the
top of the instrument (see Figure 4.3). An individual bag hanger is comprised of
a rod, a spring loaded pinch clamp with a hook from which bags can hang, and
additional supports, such as vial holders and pre-column holders. The pinch

THE CLINIMACS PRODIGY

clamp allows for individual adjustment of the hook height. NOTICE ! Risk of
damage to the bag hangers in case of overloading. The carrying capacity of a
single bag hanger is 5 kg. Do not overload the bag hangers.

Additionally, bag hanger A is equipped with a signal lamp to indicate the status
of the instrument in operation and to provide optical warning signals when
required. The signal lamp is a part of the alarm management system, described
in detail in section 5.5. In addition, bag hangers A and F are equipped with the
clamping fixture to hold the tubing set straps. 4

Double vial Pinch Dual pre-column

holder clamp holder

Hook

Signal
lamp

Clamping
fixture

Rod

1A 2 3B 4 C5 6 D7 8 E 9 F 10

23 on24
Figure 4.3: Bag hanger set mounted the instrument 11
12

13
47

16 14 15
 4.3.2 Monitor

The user interface is operated via touchscreen and manages all functions of the
CliniMACS Prodigy. Usage of the touchscreen is possible when wearing surgical
gloves. The touchscreen guides the operator through the setup procedure and
allows monitoring of the instrument during operations. The monitor unit holds
an internal speaker for acoustical signaling and alarm functionality. The
integrated USB ports allows for easy data import and export (see Figure 4.1).

4.3.3 Peristaltic pump

The peristaltic pump is used to advance the liquids through specific flow
pathways of the tubing set. A set of guide pins ensures the pump tubing stays in
place. The pump has a rotational speed sensor and a rotor position detection. If
the protection cover lid is open, the pump stops working. Do not open the
protection cover of the pump during operations unless prompted by the
graphical user interface. Integrated into the pump housing are two pressure
sensors for measuring the pressure within the tubing set. For the individual
components of the peristaltic roller pump (see Figure 4.4). The protection cover
is not shown in the diagram.

Guide pin

Pump head

Pressure
sensor

Figure 4.4: Components of the peristaltic pump

48
4.3.4 Magnet unit

The magnet unit induces a magnetic field into the separation column in order to
separate magnetically labeled cells from non-labeled cells. This unit includes
the movable, permanent magnet and a holder for the separation column (see
Figure 4.5). A linear motor with position sensors is used to place the magnet in
the ON and OFF positions. Inside the separation column, a strong
inhomogeneous magnetic field is created which retains magnetically labeled
cells within the column.

THE CLINIMACS PRODIGY

Magnet unit

Separation column

Separation
4
column holder

Tubing

Figure 4.5: Magnet unit with separation column

4.3.5 CentriCult™ Unit

The CentriCult™ Unit is a functional unit for cell processing and cell cultivation
purposes. The main components of this unit are the chamber drive unit, heat
exchange unit, Layer Detection Camera, microscope camera, and a lid which
tightly closes the CentriCult Unit (see Figure 4.6).

The chamber of the tubing set is attached to the chamber drive unit via the
chamber lock adapter inside the CentriCult Unit. The centrifugation speed is
defined by the process and controlled by sensors. The maximum centrifugation
speed does not exceed 2,500 rpm. The chamber drive unit only operates when
the lid of the CentriCult Unit is closed. In the same way, the lid of the CentriCult
Unit locks the unit and may only be opened after the chamber drive has
stopped. Note: The lid can only be opened and closed when prompted by
specific process instructions, automatically or via the « open lid » button, if
active, or via the settings menu between processes.
49
 The Layer Detection Camera utilizes proprietary technology for the detection of
different interlayers (e.g. plasma and cells) during centrifugation, allowing
controlled aspiration of cells or fluids.

The CentriCult Unit is temperature controlled by the temperature control unit

which is used to perform heating and cooling. It consists of a heat exchange
unit, peltier elements, fans, and temperature sensors including an infrared
sensor which is positioned in front of the chamber lock adapter (not visible in
Figure 4.6).

An additional microscope camera (magnification up to 400-fold) is used for

microscopic evaluation of cells cultivated in the chamber of the tubing set.
Positioning of the chamber and focusing of the lens is performed via the
graphical user interface.

Note: The microscope camera is part of the CliniMACS Prodigy Cell & Gene
Therapy Manufacturing System only.

Lid of CentriCult Unit

Layer Detection
Camera
Heat Exchange Unit
Tubing duct

Microscope camera
Chamber lock adapter

Figure 4.6: Components of the CentriCult Unit

50
4.3.6 Gas mix unit

Note: The gas mix unit is part of the CliniMACS Prodigy Cell & Gene Therapy
Manufacturing System only.

It enables the preparation of a mixture of up to three different gases for cell

culture purposes. Located at the back of the CliniMACS Prodigy are three gas
inlets with 4 mm push-in connectors for CO2, N2, and compressed air plus a
safety valve (see Figure 4.2 and Figure 4.7).

THE CLINIMACS PRODIGY

Risk of gas emission or process failure. 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. The mixture ratio of these gases is
controlled by the software and then passed into the tubing set through a
gas outlet connector at the front of the instrument (see Figure 4.1). Only
CO2, compressed air, and optionally N2 shall be used with the instrument.
The safety of the gas supply system is the responsibility of the user.
4
For a detailed description of how to apply the necessary gas connections and
required settings, refer to the appropriate CliniMACS Prodigy User Manual for
the respective application which involves the gas mix unit. Only connect gases
used in the desired process.

Safety valve

pmax=2.5 bar CO2 Air N2

Figure 4.7: Gas inlet connectors and gas safety valve

51
 4.3.7 Sensors

A variety of sensors, such as pressure sensors and liquid sensors, are used to
control the process and verify correct user handling. The pressure sensors
monitor the pressure within the tubing set to allow detection of leakages or
clogging within the tubing set. These pressure sensors are an integral part of
the pump housing (see Figure 4.4). Four liquid sensors at the front of the
instrument (see Figure 4.1) monitor the flow of liquid within the tubing set
based on an ultrasonic principle which allows detection of air bubbles within
certain parts of the mounted tubing set. Specific process steps are designed so
that disruption of continuous fluid flow through these sensors automatically
advances the process to the next phase. Additional sensors include the
temperature sensors for controlling the temperature of the CentriCult Unit and
positioning sensors for controlling parameters such as the position and speed
of the chamber or peristaltic roller pump. The temperature sensors also include
an infrared sensor which measures the temperature directly at the bottom of
the centrifugation and cultivation chamber.

4.3.8 Pinch valves

In total, 24 magnetic pinch valves can be used during operation to ensure

controlled flow pathways within the tubing set. Additionally, the valves fix the
tubing on the front plate of the instrument.

52
4.3.9 Connector panel

Safety and performance of the instrument may be compromised. Safety

and performance of the instrument may be compromised if non-
authorized accessories, transducers, and cables are used. Only
accessories, transducers, and cables, authorized by Miltenyi Biotec for the
use in combination with the CliniMACS Prodigy, are allowed to be
plugged into any of the connectors of the connector panel or any other
connector socket of the instrument. This also includes USB devices.

THE CLINIMACS PRODIGY

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 thus lead to improper operation. Only use the
instrument with accessories, transducers, and/or cables approved by 4
Miltenyi Biotec. Refer to section 4.4.

CliniMACS Prodigy manufactured as of November 2020

A connector panel with connectors for input and output connections is
positioned at the rear side of the instrument (see Figure 4.8). There are three
USB ports for data input and output functionalities.

CAN Power-CAN

TubeSealer External alarm

USB /
Bar code
reader

Figure 4.8: Connector panel (as of November 2020)

53
 The alarm connector is used for connecting an external alarm system. A relay
circuit provides 2 levels of information (see Figure 4.9); one for warning
information (Relay 2) and another for a critical alarm situation (Relay 1). All other
sockets (“CAN”, and “Power-CAN”) may be used for service purposes.

7 6
3 1
5 2 4
Relay 2 Relay 1

Figure 4.9: Relay circuit of alarm connector showing the idle state

CliniMACS Prodigy manufactured until October 2020

A connector panel with connectors for input and output connections is
positioned at the rear side of the instrument (see Figure 4.10). There are three
USB ports for data input and output functionalities. The AUX 5 pin socket is
used for the MACS TubeSealer. The alarm connector is used for connecting an
external alarm system. A relay circuit provides 2 levels of information (see
Figure 4.9); one for warning information (Relay 2) and another for a critical alarm
situation (Relay 1). All other sockets (“AUX, 3 pin”, “CAN”, and “Power-CAN”) may
be used for service purposes.

CAN Power-CAN

AUX 5 pin AUX 3 pin

External alarm
USB

Figure 4.10: Connector panel (until October 2020)

54
4.4 Accessories for the CliniMACS Prodigy®
The approved accessories, specified by the Miltenyi Biotec part number or by
technical specification, are listed in Table 4.3.

Accessory Specification
MACS TubeSealer P/N 44364

Bar code reader Zebra DS4308-HC, DS4608-HC,

or equivalent

THE CLINIMACS PRODIGY

CliniMACS Prodigy Supplementary Bag REF 200-076-612

CliniMACS Electroporator (optional) REF 170-075-704

CliniMACS Formulation Unit (optional) REF 170-075-703

USB to Ethernet adapter P/N 26128

Ethernet cable to connect the Ethernet adapter Cat5 or higher

External alarm cable Shielded cable

Table 4.3: List of accessories, transducers, and cables authorized to connect to the instrument 4

4.4.1 MACS® TubeSealer

The MACS® TubeSealer is used for sealing PVC and EVA tubing of the CliniMACS
Prodigy Tubing Sets installed on the CliniMACS Prodigy. A detailed description
of the MACS TubeSealer and relevant safety information are provided in the
MACS TubeSealer User Manual. The MACS TubeSealer must be connected to the
instrument via the TubeSealer port at the rear side of the instrument (see
Figure 4.8).

4.4.2 Bar code reader

The bar code reader is intended to scan bar codes printed on, e.g., CliniMACS
Materials, required for process execution with the CliniMACS Prodigy System.
The scanned data serve as input of part numbers and batch codes of the
CliniMACS Materials required for an application. These numbers and any other
process-related parameters may also be entered manually. The bar code reader
can be connected to any USB port of the CliniMACS Prodigy. For handling
reasons, it is recommended to connect the bar code reader to one of the three
USB ports at the rear of the instrument (see Figure 4.8).

55
 4.4.3 CliniMACS Prodigy® Supplementary Bag

The CliniMACS Prodigy® Supplementary Bag is intended to help reduce the

user's contact to potentially infectious sample material which may be
accidentally emitted out of the CliniMACS Prodigy Tubing Set. In case of a
malfunction –especially a chamber leakage– liquid might leak into the enclosed
CliniMACS Prodigy housing and will be collected inside the removable
Supplementary Bag which can be disposed of easily. The Supplementary Bag is
placed within the Supplementary Bag compartment underneath the CentriCult
Unit (see Figure 4.1). Fluids accidentally leaking out of the Chamber into the
CentriCult Unit are collected in the bag. The CentriCult Unit can then be cleaned
and the bag must be replaced by a new one. For instructions regarding the
replacement of the bag, refer to the instructions for use provided with the bag.

It is recommended to replace the Supple­mentary Bag no later than one year

after it has been installed onto the instrument, considering not to exceed the
use-by date. Therefore, the installation date must be written onto the
Supplementary Bag label beside the calendar symbol.

4.4.4 CliniMACS® Electroporator

The CliniMACS® Electroporator is a fully automatic instrument for the

electroporation of eukaryotic cells in combination with the CliniMACS Prodigy.
After electroporation, cells are further processed by the CliniMACS Prodigy. The
CliniMACS Electroporator is connected to the CliniMACS Prodigy. The
electroporation takes place in the electroporation cuvette. The electroporation
cuvette is part of CliniMACS Prodigy Tubing Sets and is placed in the
electroporation unit of the CliniMACS Electroporator.

Different types of eukaryotic cells can be electroporated. This technique allows

the transfection of cells with nucleic acids, proteins or other small molecules.
The CliniMACS Electroporator is intended to be used in combination with the
following components: CliniMACS Prodigy, CliniMACS Reagents, CliniMACS
Prodigy Tubing Sets, CliniMACS PBS/EDTA Buffer, and CliniMACS Electroporation
Buffer. Refer to the CliniMACS Electroporator User Manual for further
information.

56
4.4.5 CliniMACS® Formulation Unit

The CliniMACS® Formulation Unit is an instrument accessory for the automated

final formulation and sampling of eukaryotic cells in combination with the
CliniMACS Prodigy. The CliniMACS Formulation Unit enables the user to take
cells during or after processing by the CliniMACS Prodigy. The CliniMACS
Formulation Unit is mounted onto the bag compartment of the CliniMACS
Prodigy and powered by the CliniMACS Prodigy via the Power-CAN connector.
Refer to the CliniMACS Formulation Unit User Manual for further information.

THE CLINIMACS PRODIGY

4.5 Unpacking and installation

Risk of damage to the CliniMACS Prodigy. Risk of damage to the instrument if

the instrument is unpacked or installed by unauthorized persons. Unpacking
and installation of the instrument must only be performed by an authorized
local Miltenyi Biotec Service Provider. Read chapter 3 "Important safety
information" before installation and use of the instrument. Visually inspect 4
and note any significant damage to the package. Damage may require
inspection by a representative of the shipping company.

4.5.1 Scope of supply

The content of supply is:

• One CliniMACS Prodigy

• One power cord (country specific)
• Six bag hangers equipped with specific mounting supports,
one bag hanger is additionally equipped with an LED lamp
• Accessories: MACS TubeSealer, bar code reader, two CliniMACS Prodigy
Supplementary Bags including instructions for use
• Holder (frame and inlay) for MACS TubeSealer and bar code reader
• Instructions for use for the CliniMACS Prodigy

57
 4.5.2 Transport

Risk of internal damage. Internal damage can occur if the instrument is

subjected to excessive vibration or if it is dropped. The CliniMACS Prodigy
should be transported with care in packaging specified by Miltenyi Biotec.

Chemical and biological hazard. Risk of chemical or biological hazards

due to contaminated surfaces. If the instrument needs to be shipped back
to the manufacturer for service, decontaminate the instrument from any
hazardous material prior to shipment. For questions regarding proper
decontamination or shipment, contact Miltenyi Biotec Technical Support
for assistance.

Ergonomic hazard or damage to the instrument. If the instrument is lifted by

one person there is the risk of personal injury or damage to the instrument.
The instrument should be lifted by at least two people. Do not lift the
instrument by the monitor, CentriCult Unit, peristaltic pump, or magnet unit.

4.5.3 Positioning

Electrical hazard. To avoid electrical hazards it must be possible to

interrupt the power supply at any time. The power connection including
the fuse holder and the main switch must be accessible at all times.

Risk of overheating. Risk of overheating in case of reduced air circulation. Do

not place the instrument with the back side directly against the wall. Keep at
least 14 cm distance to allow free air circulation. Allow sufficient space
around the ventilation slots at the rear and underneath the instrument. Take
into consideration that the instrument requires adequate air circulation for
heat exchange and cooling. Read the chapter “Important safety information”
to avoid the risk of overheating.

Risk of serious harm and/or serious damage to the instrument. The

CliniMACS Prodigy could fall and cause serious harm and/or serious damage
to the instrument. The instrument must be placed evenly on a flat and stable
surface which is capable of supporting 100 kg and free of vibrational or other
mechanical forces. Do not locate the instrument next to vibrating equipment
58 which might cause movement during operation.
Noise level
If the instrument is used at maximum load, it might produce noise up to
63 dB(A). Ensure that alarm signals from other instruments are noticeable.

4.6 Cleaning and disinfection

Risk of electric shock or damage to the instrument. Risk of electric shock

or damage to the instrument if the CliniMACS Prodigy is cleaned with

THE CLINIMACS PRODIGY

excessive amount of cleaning agent or while switched on. Only clean the
instrument when it is switched off and the power cord is unplugged.
Avoid ingress of any liquid into the valves and into the liquid sensor. Do
not use an excessive amount of cleaning or disinfection agents to avoid
spilling into the gas outlet connector. After cleaning, dry all excess liquid
from the valves, pump head, gas outlet connector etc.

4
Safety and performance of the instrument may be compromised. Safety
and performance of the instrument may be compromised if other than
the above mentioned cleaning methods are used. UV may damage plastic
parts of the instrument. Do not use UV irradiation. The instrument should
not be sterilized, e.g., with H2O2.

Clean the instrument with one of the following disinfectants, which are
compatible with the surface of the instrument:

• Aldehyde up to 3%, e.g., Melsitt® 3% or Kohrsolin® FF 3%, or

• Ethanol up to 80%.

Dust off the valves, peristaltic pump, and magnet unit using a paper towel or
absorbent material.

In case of contamination, e.g., due to leakage in the CentriCult Unit, see chapter 7.

IMPORTANT
The surface of the instrument, including the CentriCult Unit and the bag
compartment, should be cleaned at regular intervals and after each application.
Cleaning after unpacking and installation is also recommended.

59
 4.7 Maintenance

Hazard to users, unpredictable results, instrument malfunction or

damage, premature wear and reduced life time of the instrument.
Improper or incorrect servicing or repair of the instrument can cause
hazards to users, lead to unpredictable results, instrument malfunction
or damage, premature wear and reduced life time of the instrument, and
may void the warranty. Unless otherwise specifically noted in this user
manual, do not service the CliniMACS Prodigy. Service and repair may
only be performed by authorized local Miltenyi Biotec Service Provider.
Routine and preventative maintenance procedures should be conducted
by the manufacturer’s authorized service personnel at least once a year.

The CliniMACS Prodigy does not require any form of calibration. Contact the
authorized local Miltenyi Biotec Service Provider for instrument service and
support arrangements.

4.8 Disposal
Contact Miltenyi Biotec Technical Support for final disposal. The CliniMACS
Prodigy must be separately collected according to the European directive of
waste of electrical and electronic equipment (WEEE). For final disposal, the
instrument must be returned to the manufacturer. Clean the instrument
according to the instructions given in section 4.6. The instrument should be
transported with care in packaging specified by Miltenyi Biotec.

Biological hazard. If the instrument is transported without prior

disinfection there is the risk of infection. Clean and disinfect the
instrument according to the instructions given in section 4.6.

60
5
The CliniMACS Prodigy® Software

THE CLINIMACS PRODIGY SOFTWARE

The CliniMACS Prodigy® Software allows the operator to choose between
processes and user programs and control certain instrument functionalities. The
following notations are used to describe software elements:

• Text in bold gray indicates elements available for selection (e.g. press
buttons), 5
3
• Text in bold light green indicates dialog boxes.

5.1 Touchscreen
5.1.1 Use of touchscreen

The CliniMACS Prodigy is equipped with a high-resolution touchscreen. All

elements of the instrument software are operated via the touchscreen. Two
simple gestures of fingers are detected by the touchscreen.

Press: A short contact of touchscreen elements with fingers is called a ”press“.

This gesture is used to start a process, to mark data, or to interact with a
process during dialog control.

Hold: Contact and holding of a spot on the touchscreen will be detected as a

gesture by some control elements (e.g. lists). This gesture is used for
quickly scrolling through lists.

The touchscreen can detect gestures with gloved fingers.

61
 5.1.2 General setup menu

After switching on the power of the CliniMACS Prodigy, the software starts up
and the start screen appears for a short time (approx. 5 seconds).

The start screen provides information about the software version and the result
of the initialization process. After the initialization process, the menu button
Processes is selected automatically and within the list of processes, the first one
is highlighted automatically.

5.2 Login, logout, and emergency stop

With software version 2.0, the software feature "Application Services" has been
introduced. These services comprise the 21 CFR Part 11-supporting
functionalities “Audit Trail” and “User Management” (see section 5.4) including
an authentication procedure. Consequently, a login is required by any user who
wants to interact with the instrument.

In software version 2.0, two new dynamic buttons were introduced, a « Login »
button which is positioned in the upper right corner of the screen and an
« Emergency Stop » button in the lower left corner. Upon switching on the
CliniMACS Prodigy, a locked screen will appear which has a darker color
compared to an unlocked screen and which shows these two buttons (see
Figure 5.1).

Login button

Emergency
Stop button

Figure 5.1: Locked starting screen

62
5.2.1 Login

To interact with the instrument, a user must login with the user name and
password using the « Login » button in the upper right corner of the screen (see
Figure 5.1). Pressing the button opens the pop-up window "User Login". After
entering user name and password and pressing « Login » within the pop-up
window, the screen will unlock.

Note: If there is no interaction with the instrument for 20 minutes, the screen

THE CLINIMACS PRODIGY SOFTWARE

will be locked again showing the activated login button.

Risk of process failure if the instrument login is not possible anymore. In

order to avoid such a situation, appropriate user and administrator accounts
with distinct passwords need to be created before starting to run
applications on the CliniMACS Prodigy. In addition, it is highly recommended
to establish a so-called “break-glass solution” for emergency situations
allowing the login for an individual user lacking sufficient access rights. This
could be a closed envelope near the instrument containing user name and
password of such an emergency account. Such a solution should be simple
and quickly available without unreasonable administrative delay. In general, 5
the authentication procedure should be described and implemented within
3
the quality management system of the facility and all users and
administrators need to be trained accordingly. In case an instrument login is
not possible anymore, contact Miltenyi Biotec Technical Support.

5.2.2 Logout

If there is no interaction with the instrument required for a certain time period,
a user can logout using the logout function within the Application Services
menu (see Figure 5.3). The screen will then be locked again and the status
screen will be shown.

63
 5.2.3 Emergency Stop

The « Emergency Stop » functionality enables an immediate pause of a running

application or a tool in case of an emergency situation when no user is logged
in, without violating 21 CFR Part 11 requirements to the audit trail. In such a
case, the software requests a reason for the emergency stop and a subsequent
login. This information is then captured in the Audit Trail. The « Emergency
Stop » button is only activated (indicated by the colors yellow and red) when an
application or a tool is running and no user is logged in.

Note: The « Emergency Stop » does not completely switch off the instrument, it
has the same function as the « stop » button during a running application when
a user is logged in.

5.3 The graphic user interface

5.3.1 Operating controls

The display of the user interface is divided into several sections (operating
controls) performing different tasks. During software operation, operating
controls are adapted automatically to different process requirements. The basic
operation controls are the menu bar, tool bar, and status line (see Figure 5.2). In
addition, there are two or more windows which may be positioned differently
according to the current status of a process or the active menu.

Note: The following figures are examples of the graphic user interface. Parts of
the text presented on the screens in the user manual may differ slightly from
the screens displayed on the instrument. The configuration of elements
depends on the status of the process. With the continuous development of new
processes and software features, additional content may be displayed on the
instrument screens which may not always be shown in the following figures.

64
 Menu bar
Status line

THE CLINIMACS PRODIGY SOFTWARE

List of processes Text field Tool bar

Figure 5.2: Operating controls (up to software version 1.4)

5
Menu bar 3
The software offers several menu buttons for different functionalities (see
Figure 5.2). A menu is selected by pressing the respective menu button. A green
background indicates which menu button is active. Depending on the current
status of the software program, some menu buttons are not available for
selection as indicated by a change of font color from green to gray. For details
regarding menus (see section 5.3.2).

Note: As of software version 2.0, an additional menu button for the menu
Application Services was added to the menu bar (see Figure 5.3).

65
 Application
Services

Figure 5.3: New Application Services button in menu bar as of software version 2.0

Lists
Lists consist of similar elements, e.g., list of processes (see Figure 5.2) or user
programs. Each list element can be chosen and marked by directly pressing the
element or by using the « up » and « down » navigation buttons of the tool bar.
Holding the navigation buttons will quickly scroll through the list elements.
A list is always shown in a window with light blue background color.

Status line
The status line (see Figure 5.2) contains brief information regarding the status of
the current process.

66
Tool bar
The tool bar shows the changing functions of the touch buttons and is divided
in a dynamic and static part. The static buttons of the tool bar are the « stop »,
navigation, « undo », « edit », and « ok » buttons (see Figure 5.4). The wording of
the « ok » button may change to « run » whenever a process or a program needs
to be started.

Depending on the activated menu group, the dynamic part of the tool bar
changes the appearance and functions of the touch buttons. The functions of

THE CLINIMACS PRODIGY SOFTWARE

the touch buttons in the static part remain unchanged and are independent of
the selected menu group.

Dynamic buttons
(context dependent)
5
3

Menu navigation

Start/confirm

Figure 5.4: Dynamic and static buttons of the tool bar

67
 Static buttons
The functions of the static buttons (see Figure 5.4) do not change with respect
to the different menus. The only exception is the « ok » button which changes
into a « run » button whenever there is a process, a user program, or any other
procedure to be started.

• Stop button
The « stop » button is available in every menu group and can be used
according to the status of a process. The « stop » button is active when
showing a green symbol. This is the case when a process is running. When
the active « stop » button is pressed, the process run will be interrupted. The
font color of the stop button changes from green to gray to indicate that no
process is running and the « stop » button is inactive.

• Navigation buttons
The navigation buttons are used to select elements from a list or navigate in
images from the camera (see section 5.3.2).

• Undo button
The « undo » button enables the operator to revoke one or more inputs to
restore the original content of the screen. The « undo » button is not active in
all screens.

• Ok/Run button
Depending on the activated menu, pressing the « ok » button will confirm a
selection by the operator or will close the active menu. The « ok » button
turns into a « run » button whenever there is a process, user program, or any
other procedure to be started.

• Edit button
The « edit » button activates the input field for manual data input when
required.

68
Dynamic buttons
The functions of the buttons (see Figure 5.4) in the dynamic part will change
according to the activated menu and the currently running application.

• Open lid button

The « open lid » button enables the customer to manually open the
CentriCult Unit lid. This button is only visible and/or active according to the
selected menu and status of the process running.

THE CLINIMACS PRODIGY SOFTWARE

• Save button
The « save » button enables the operator to save a process protocol on a USB
stick. The save functionality is only available in the Filed data menu.

• Camera menu
The « camera » button opens the camera menu (see section 5.3.2). The
button is only available in processes enabling camera functionality.

Input fields
During a process, the operator may be asked to manually enter parameters such
as names or numbers. An input field is displayed on the screen that represents 5
the functionality of a keypad and allows for the input of letters or numbers (see
3
Figure 5.5).

Escape

Switch from
letters to
numbers

Figure 5.5: The input field – keypad with letters

For manual entry of capital letters, press « », for space press « SP », for numbers
press « ?123 », and for backspace press « ».

69
 5.3.2 Menus

Processes menu
After start up and initialization of the CliniMACS Prodigy Software, the menu
Processes is selected automatically. The central element of this menu is the list
of processes that can be performed (see Figure 5.2, left light blue-colored
window). Individual processes may be selected by directly pressing on the
process name or by using the navigation buttons. The text field (see Figure 5.2,
right window) contains brief information regarding the selected process and its
version number. Press the « run » button to start the selected process.

During a process run, additional control elements such as “instructions” or a

“progress bar” are available. The availability of these control elements depend
on the status of the process. These elements are explained in more detail in the
application user manuals.

The displayed instructions tell the operator to carry out the actions required for
a process (e.g. installation of the tubing set). Instructions are given in written
form and, whenever possible, include corresponding schematic drawings to
further explain the required actions. The progress bar shows the process name
and the remaining time of the process running.

Status menu
The Status menu is opened by pressing the « Status » button. The status menu
provides information regarding the operational state of the running process.
When no process is running, the status screen is blank.

The status screen is grouped into the following elements:

• Process-related parameters
This element displays a list of all relevant process parameters. The list may
contain up to 20 different parameters (see Figure 5.6, left window).

• Info box and progress status

This element (see Figure 5.6, upper right window) contains the operator’s
name and information about the sample. It also contains two progress bars
showing the progress of the process running. The lower progress bar shows
the remaining time before the whole process is finished. The upper progress
bar displays the remaining time of the subprocess running.

70
• Graphic overview
The graphic overview element (see Figure 5.6, lower right window) provides
visual information about the running subprocess status of the instrument.
All activities of the instrument components (peristaltic pump, pinch valves,
etc.) are visualized in orange. In this menu, the tool bar offers additional
functions.

The « stop » button may be used to interrupt the execution of the process. The
« camera » button selects the subcamera menu (see section 5.3.2).

THE CLINIMACS PRODIGY SOFTWARE

Info box
Camera menu

Progress
bars
Process
parameters
5
3
Graphic
overview

Figure 5.6: Overview of process status

Camera menu
There are two camera functionalities which can be selected by pressing the
« camera » button within the tool bar. The first functionality shows images of the
Layer Detection Camera during centrifugation. In addition, graphical
information is provided about the volumes of the centrifugation fractions
automatically detected by the Layer Detection Camera. The second camera
functionality refers to images provided by the microscope camera. These two
functionalities cannot be active at the same time. As a consequence, during
some processes, the microscope camera may never be active.

Note: The camera menu is positioned within the menu group Settings and may
be selected during a process by pressing the « camera » button in the tool bar. If
the camera menu is not enabled, the « camera » button is gray and inactive.

71
 Layer Detection Camera
The camera menu shows the last image saved by the Layer Detection Camera.
Red and orange bars mark the position of the layers within the image. A
diagram below the image continuously displays the recorded values for the
volumes of the centrifugation fractions. The curves are displayed in red and
orange corresponding to the bars within the image (see Figure 5.7).

The operator may use the following functionalities if enabled:

• Image recording:
If the « snap » button is active, pressing the button will prompt the camera to
record a new image. After a short recording phase (approx. 15 seconds), the
displayed image will be replaced by a newly recorded image.

• Image archiving:
The recorded image may be saved by pressing the « save » button. The
recorded image will be integrated in the protocol of the current process.

• Quitting camera menu:

Quit the camera menu by pressing the « ok » button.

Image of
layers

Volumes of
layers over
time

Figure 5.7: Status screen when Layer Detection Camera is active

72
Microscope camera
Note: The microscope camera is part of the CliniMACS Prodigy Cell & Gene
Therapy Manufacturing System only.

It is only active in processes with cell culture procedures. The magnification of

the images is up to 400-fold. As with the Layer Detection Camera, the camera
menu shows the last image saved by the integrated microscope camera (see
Figure 5.8).

THE CLINIMACS PRODIGY SOFTWARE

The operator may use the following functionalities if enabled:

• Navigation within an image:

Touching the image of the microscope camera will result in a 2-times
magnification. The point of touch will be the new center of the image. The
navigation buttons allow further navigation within the image. Pressing a
navigation button will result in a shift by half a frame in the selected
direction. Image roll bars show the absolute position of the image section in
the whole image to facilitate the navigation. The last ten navigation steps
can be undone separately by repeatedly pressing the « undo » button.
5
• Image recording: 3
If the « snap » button is active, pressing the button will prompt the camera to
record a new image. After a short recording phase (approx. 15 seconds), the
displayed image will be replaced by a newly recorded image.

• Image archiving:
The recorded image may be saved by pressing the « save » button. The
recorded image will be integrated in the protocol of the current process.

• Quitting camera menu:

Quit the camera menu by pressing the « ok » button.

73
 Figure 5.8: Status screen when microscope camera is active

74
User programs menu
Note: The microscope camera is part of the CliniMACS Prodigy Cell & Gene
Therapy Manufacturing System only.

The menu User programs offers space for generic, pre-installed programs as
well as for customized tailor-made programs. Customized programs can be
requested from the Miltenyi Biotec Customized Application (CAP) Service. This
service offers individual programming of a customer specific protocol meeting
specific user requirements. For more information, contact Miltenyi Biotec

THE CLINIMACS PRODIGY SOFTWARE

Technical Support.

The operator may choose from a list of user programs (see Figure 5.9, left
window: the names listed here are examples of potential user program names).
The text field (see Figure 5.9, right window) contains brief information regarding
the selected user program.

5
3

List of processes Text field Tool bar

Figure 5.9: List of user programs

75
 Filed data menu
The menu Filed data contains a list of protocols indicating all processes
executed on the instrument. The list provides information regarding the
relevant parameters of the individual process runs, for example, the date and
duration of a process.

Note: The menu Filed data is not available during a process run. The respective
touch button is inactive.

For each process, a protocol will be saved and stored within this menu
(Figure 5.10). By selecting a process from the list, the respective protocol will be
displayed by pressing the « ok » button. The displayed protocol may be saved as
a PDF onto a USB stick by pressing the activated « save » button. The USB stick
must be inserted into the USB port at the side of the touchscreen.

Figure 5.10: Example of a process protocol

76
Settings menu
In the menu Settings, the operator will find additional programs for
configuration and survey of the instrument. When the menu is selected, three
columns are displayed. The active window is indicated by a light blue
background color.

All programs in this menu are grouped in different categories (Option groups)
that are listed in the left window. All programs contained in a category are listed
in the middle window (Option programs). The right window (Program

THE CLINIMACS PRODIGY SOFTWARE

description) displays a text field where information about the selected program
are indicated.

Categories and programs may be selected by directly pressing the selection or

by using the navigation buttons. The navigation buttons « left » and « right »
select the category and program lists. Navigation buttons « up » and « down »
select the list elements.

Start a selected program by pressing « run ».

5
3

Option Option Program

groups programs description

Figure 5.11: Menu “Settings”

77
 5.4 Application Services
With the CliniMACS Prodigy software version 2.0, new functionalities have been
integrated as the “Application Services” into the software. These services
comprise a user management module including authentication features and an
audit trail module which are essential to support 21 CFR Part 11 compatibility.
When pressing the application services menu button, a pop-up window will
appear which allows the selection of several service menus, e.g. Logout or User
setup (see Screen 5.1).

Screen 5.1: Pop-up window “Application Services”

78
5.4.1 User Management

To establish the user management functionality on the CliniMACS Prodigy, it is

necessary to create individual accounts for all users of a given instrument and to
define their individual set of roles.

In principal, there are two main user categories: operators and administrators.
An operator starts and runs applications on the CliniMACS Prodigy. Operator
accounts must be set up to allow running a particular set of applications and

THE CLINIMACS PRODIGY SOFTWARE

some important tools for support and troubleshooting purposes. An
administrator manages accounts and the instrument. The administrator account
would typically allow the setup and changes of accounts and provides access to
file management and advanced tools for instrument settings.

Creation of a new account

To create a new user account, « User setup » has to be selected within the
pop-up window of the Application Services (see Screen 5.2) which leads to the
User Management menu. For each account, user details, a password, and
specific roles must be defined.
5
IMPORTANT 3
To enter the User Management menu, a user will need administration rights to do so.
It is therefore essential to create administrator accounts upon installing software
version 2.0 onto the instrument!

The User Management menu comprises four submenus (see Screen 5.2): Users,
LDAP Groups, Roles, and Configuration. Upon selection of the User
Management menu, the submenu Users is shown which contains a list of all
previously set up accounts with all account details.

79
 Screen 5.2: Menu “User Management”

Note: The submenu LDAP Groups is not active for use in software version 2.0. In
addition, the displayed account “cmp-service” in the example shown in Screen
5.2 represents a pre-installed account for Miltenyi Biotec Instrument Service
staff. Such accounts cannot be deleted nor adapted.

80
Pressing « + New User » leads to a new submenu for the creation of a new
account with its own ID, user details, password, and the assignment of specific
roles. All assignable roles are listed in the first tab Role under “Available Roles”
(see Screen 5.3). This list includes operator roles for all applications (e.g. “CCS-
IFN v3.0 Operator”) and tools (e.g. “Common tools user”) and administrator roles
(e.g. “Administration tools user”). For further descriptions of the roles, see
section "Roles and rights".

After entering an account ID (e.g. “User4” ), all required roles for this specific user

THE CLINIMACS PRODIGY SOFTWARE

can be selected by shifting these from the left window “Available Roles” to the
right window “Assigned Roles” using the arrows between the two lists.

IMPORTANT
For an operator, the role “UM User” must be assigned. For an administrator, the role
“UM Administrator” must be assigned.

5
3

Screen 5.3: Assigning roles to a specific user

81
 The password to this account has to be assigned by opening the tab
Authentication. The password must be set according to the password policy
which may be adapted in the submenu Configuration under tab Password
Policies. Further user details, e.g. name, initials etc., can be defined by opening
the third tab Local User Details. The new account is now saved and appears in
the accounts list shown in Screen 5.2.

Note: For the descriptions in this user manual, “functional” user names like
“User1” or “Admin1” have been chosen to better explain how to set up these
accounts. In a true GMP environment, real names or synonyms which can be
clearly differentiated and recognized must be used.

Screen 5.4: Submenu “Roles” with a list of existing roles

82
Roles and rights
The submenu Roles in the menu User Management contains a list with all
available pre-defined roles for setting up user accounts and a short description
of the individual roles (Screen 5.4). For further description, see Table 5.1.

For administrators, it is possible to create new roles in a certain limited manner

by using a list of rights for tools and applications in a new screen which is
entered by pressing « + Add New Role ».

THE CLINIMACS PRODIGY SOFTWARE

Note: This new window also contains rights for Miltenyi Biotec Instrument
Service which are not activated for local administrators.

Table 5.1 lists the different roles available in software version 2.0 and explains
the tools or rights which are associated with this role. The specific applications
which can be assigned to an operator are represented by “Application vx.x
Operator”.

Role Tools/Rights
Application vx.x Permission to run this application with version number x.x
operator 5
ATS user Access to Audit Trail including the right to delete
3
Administration tools user Access to tools for administrating the instrument

Common tools user Access to common tools: info, license, shutdown, user
settings

File management user Allows backup of filed data and custom files

Gas mix tool v1.0 Access to the gas mix tool

Operator

Injected programs Permission to run injected programs

N2 settings tools user Access N2 settings tool

Set time user Allows to set the time

Support tools user Chamber in, chamber out, sealer, instrument check

UM Administrator Access to the User Management allowing to manage

accounts
Note: The role must be assigned to an administrator.

UM user Defined operator who shall start and run user applications
Note: The role must be assigned to an operator.
Table 5.1: Description of different roles in software version 2.0

83
 Configuration
The submenu Configuration in the menu User Management allows the setup
of all relevant password settings, e.g., definition of characters to be used,
password length, or number of login attempts according to the security
guidelines of the customer under tab Password Policy (see Screen 5.5).

Screen 5.5: Submenu “Configuration” with active “Password Policy” tab

Opening the tab Import/Export allows the export of user management setting
like custom roles, user setups, or password policies onto a USB device which can
be used for settings on different CliniMACS Prodigy in the same facility.

84
Audit Trail
Note: In order to enable a user to utilize audit trail functionality, the role “ATS
User” must be assigned to this user. The default role “ATS User” allows users to
read, export and delete audit trail events. It is possible for the administrator of a
given user’s account to create a new role with reduced Audit Trail rights, e.g., to
only read and export Audit Trail events (see also section “Roles and rights”).

The Audit Trail menu can be entered by selecting « Audit Reporting » in the
pop-up window “Application Services” (see Screen 5.1). The menu contains a list

THE CLINIMACS PRODIGY SOFTWARE

of all available audit trail events on the instrument. This list can be filtered by
date or the description of the events if needed. The screen in Screen 5.6 shows
an example of eight events out of a list with 603 events in total. By scrolling
through the list all events could be checked and eventually be exported, e.g., as
a PDF to a USB device inserted to the CliniMACS Prodigy using the « Create
Export » button.

5
3

Screen 5.6: Menu “Audit Trail”

85
 Similarly, a set of events within a selected time frame can be deleted by pressing
the « Delete Events » button. In this case, a pop-up window appears, providing a
statement that audit trail data should not be deleted before they had been
archived (see Screen 5.7). The selected events will be deleted upon pressing
« Continue Delete ». After the deletion of the events, a new audit trail event will
be generated showing the time of deletion and the number of the deleted
events.

Screen 5.7: Warning pop-up to delete audit trail events

5.5 Alarm management

The CliniMACS Prodigy is equipped with an integrated alarm management
system which is spread over several components, providing optical and
acoustical alarm signals if required. An additional relay circuit may be connected
to an external alarm system. Relay 1 indicates a critical situation which requires
immediate user interaction. Relay 2 indicates a required user interaction (see
also section 4.3.9).

86
The alarm management system of the instrument features a three-level alarm
system. In case of a failure, a message is displayed on the monitor, accompanied
by an audible warning signal from a speaker within the touchscreen. The signal
lamp at the bag hanger A (see Figure 4.3) will then display a red blinking light.

The instrument distinguishes between three alarm levels as described in Table 5.2.

Alarm level Description

Level 1: Hint A hint message is used to provide the user with information, e.g., on

THE CLINIMACS PRODIGY SOFTWARE

how to continue with the selected procedure. A user action may be
necessary. If a user action is required, the signal lamp displays a blue
blinking light. At this level, relay circuit 2 is inactive.

Level 2: Warning A warning message shows warnings that require the user’s
attention, e.g., sensors detect unexpected values. If a warning
message appears, the signal lamp displays a yellow blinking light. In
addition, relay circuit 2 is active.

Level 3: Alarm Alarm messages point out system interrupts referring to safety
relevant steps that await an obligatory user action. If an alarm
message appears, the signal lamp displays a red blinking light. In
addition, the speaker provides an acoustical alarm signal and relay
circuit 1 is active.
Table 5.2: Alarm levels of the instrument 5
3
The signal lamp
An LED signal lamp is positioned at the top end of the bag hanger A (see
Figure 4.3). This signal lamp provides instrument status information by
displaying different colors, as described in Table 5.3.

Color Description
White The instrument is ready for use and a process may be started.

Green A process is running. No interaction required.

Blue The instrument requires user interaction.

Yellow Warning (time critical), user interaction required

Red Alarm, critical situation, process failure possible, user interaction required
Table 5.3: Color code of the signal lamp

Note: Whenever a user interaction is required, the signal lights will blink. This is
the case with the blue, yellow, and red color lights.

87
88
6
The CliniMACS Prodigy® System

THE CLINIMACS PRODIGY SYSTEM

6.1 The CliniMACS Prodigy® System components
The different applications run on the CliniMACS Prodigy® require the use of
specific CliniMACS Prodigy System components as well as additional materials
and equipment as described in the CliniMACS Prodigy User Manual for the
respective application. The following CliniMACS Materials may be part of a
CliniMACS Prodigy System: 3
• The CliniMACS Prodigy including the accessories MACS TubeSealer, bar
6
code reader, and CliniMACS Prodigy Supplementary Bag (as described in this
user manual).

• CliniMACS Reagents and Biotin Conjugates are intended for in vitro

magnetic labeling of human cells to enable the separation of specific human
cells with a CliniMACS System for clinical applications. The CliniMACS
Reagents are dark colored, non-viscous, colloidal solutions containing the
cell specific antibody conjugates in buffer. The reagents consist of the
antibody chemically coupled to super-paramagnetic particles. The
CliniMACS Biotin Conjugates are clear and colorless solutions containing
antibody covalently linked to biotin in buffer. The antibodies are highly
specific, making labeling of rare target cells possible.

• CliniMACS Prodigy Tubing Sets are intended for in vitro separation of

human cells from heterogeneous haematologic cell populations in
combination with the CliniMACS Prodigy System only. The different tubing
sets have been developed for the special requirements of the respective
application for use in combi­nation with the CliniMACS Prodigy System only.
They consist of pre-assem­bled tubing, pre-assembled bags, and other
components as required.
89
 • CliniMACS PBS/EDTA Buffer is intended as wash and transport fluid to
enable the in vitro separation of human cells with a CliniMACS System only. It
is used as process buffer during cell separation and is provided in 1000 mL or
3000 mL sterilized plastic bags, individually packed.

IMPORTANT
For instructions for use, e.g., warnings and precautions concerning the CliniMACS
Prodigy System components, refer to the instructions for use provided for the
respective component.

6.2 Additional materials and equipment

Additional materials, e.g., CliniMACS Prodigy Accessories or MACS GMP
Products, and equipment required for the different applications are described in
the CliniMACS Prodigy User Manual of the respective application.

IMPORTANT
The procedures may require the use of components which are not part of the
CliniMACS Prodigy System. Therefore, either materials of pharmaceutical grade must
be used or the user has to evaluate all risks arising from these materials. In addition,
no inflammable or explosive materials should be used, or solutions that will lead to a
hazardous chemical reaction that could represent a potential risk for the user.

6.3 Limitation
Miltenyi Biotec as the manufacturer of the CliniMACS System does not give any
recommendations regarding the use of separated cells for therapeutic purposes
and does not make any claims regarding a clinical benefit.

90
6.4 Warnings and precautions regarding the process

Risk of process failure or damage to the instrument. Risk of process

failure or damage to the instrument if procedures are performed by
untrained operators. All processing procedures must be performed by
trained operators only. Operator training will be provided by a qualified
Miltenyi Biotec representative.

• For the manufacturing and use of target cells in humans the national
legislation and regulations – e.g. for the EU the Directive 2004/23/EC (human
tissues and cells) or the Directive 2002/98/EC (human blood and blood

THE CLINIMACS PRODIGY SYSTEM

components) – must be followed. Thus, any clinical application of the target
cells is exclusively within the responsibility of the user of a CliniMACS System.

• All materials, which have come into contact with blood and blood products,
must be treated as infectious material. Regulations for the handling of
infectious material must be observed.

• All cell preparation and labeling procedures must be performed at room

temperature (+19 °C to +25 °C [+66 °F to +77 °F]) unless otherwise stated.
Higher or lower temperatures may result in reduced purity and lower yield of
3
the target cells. 6
• All tubing, fittings, valves, the pre-column, and the separation column
should be checked thoroughly for leaks during the priming step.

• All bags should be retained until final analysis of all cells has been completed
and successful processing of the target cells has been confirmed.

91
 6.5 Warnings and precautions regarding the
handling of biohazardous material
• To avoid contamination of the cellular starting product, all preparation steps
should be performed using aseptic techniques.

• The operator performing the cell processing must be trained in the proper
use of the equipment and in the handling of blood products and bone
marrow aspirates.

• The operator performing the cell separation should wear appropriate

clothing (e.g. lab coat, gloves, and protective glasses or goggles) when
working with a patient sample and handling potentially biohazardous
material.

• All blood products must be treated as a potential biohazard. Leukapheresis

product, blood product, bone marrow aspirate, collected cells, used buffer,
used tubing set, and other materials, which have been in contact with these
fluids, must be treated as biohazardous materials according to standard
hospital or institutional requirements.

• The CliniMACS Prodigy should be considered as potential biohazard after

each run and cleaned with an aqueous biocidal detergent (see section 4.6)
according to standard hospital or institutional requirements.

• Disposable materials must be treated according to standard hospital or

institutional requirements for biohazardous materials.

92
6.6 Warnings and precautions regarding the cellular
starting product
IMPORTANT
Labeling and processing of cells should begin as soon as possible after the cellular
starting product has been collected. It is recommended to start all labeling and
processing procedures within 24 h after the cell collection.

• The cellular starting product (e.g. leukapheresis product, buffy coat, etc.)
should be collected according to standard hospital or institutional
procedures in standard collection bags. Bone marrow aspirate should be
collected in heparin-coated containers (e.g. 5 mL syringes). Prior to the cell

THE CLINIMACS PRODIGY SYSTEM

labeling procedure, no additional anticoagulants or blood additives
(heparin, etc.) should be included beyond those normally used during
leukapheresis or during bone marrow aspiration.

• The container with the cellular starting product should be labeled with
patient identification, time, date, and place of collection according to
procedures specified for use with the clinical protocol.

• For transportation, the cellular starting product should be packed in 3

insulated containers and be kept at controlled room temperature (+19 °C to
+25 °C [+66 °F to +77 °F]) according to standard hospital or institutional
6
blood collection procedures approved for use with the clinical protocol. Do
not refrigerate. The cell concentration should not exceed 0.2×109 cells per
mL during transportation.

• For transportation of the bone marrow aspirate, the product should be

packed in insulated containers and be kept at controlled temperature (+2 °C
to +8 °C [+36 °F to +46 °F]).

• Avoid intensive mixing of the cellular starting material.

• If the cellular starting product has to be stored, e.g., overnight, it should be

kept at controlled room temperature (+19 °C to +25 °C [+66 °F to +77 °F]).
Bone marrow aspirate should be kept at controlled temperature (+4 °C
[+39 °F]). During storage, the concentration of leukocytes should never
exceed 0.2×109 cells per mL.

• Cells should be stored in autologous plasma. If the cell concentration is

higher than 0.2×109 cells per mL, dilute the cellular starting product with
autologous plasma.

93
94
7
Troubleshooting

7.1 Instrument malfunction or process failure

In any case of instrument malfunction or process failure, contact the Miltenyi
Biotec Technical Support:

Troubleshooting
 +49 2204 8306-3803
[email protected] 3
Visit www.miltenyibiotec.com for local Miltenyi Biotec Technical Support
contact information.
7
7.2 Instrument cleaning after leakage
In case leakage occurs, e.g., in the CentriCult Unit, additional cleaning measures
are required. For further information contact the Miltenyi Biotec Technical
Support.

95
96
8
Legal notes

8.1 Limited warranty

Except as stated in a specific warranty statement, which may accompany this
Miltenyi Biotec product, or unless otherwise agreed in writing by a duly
authorized Miltenyi Biotec representative, Miltenyi Biotec’s warranty for
products purchased directly from Miltenyi Biotec shall be subject to the terms
and conditions of sale under which it was provided to you by the respective
Miltenyi Biotec sales organization. These terms and conditions are available on

Legal notes
request or at www.miltenyibiotec.com. The applicable terms and conditions of
sale may vary by country and region. Nothing herein should be construed as
constituting an additional warranty.

For products purchased from third-party retailers or resellers (e.g. purchased 8

from an authorized local Miltenyi Biotec Service Provider), different terms and
conditions may apply.

To determine the warranty that came with your product, see your packing slip,
invoice, receipt or other sales documentation. Some components of a product
combination you purchased may have a shorter warranty than that listed on
your packing slip, invoice, receipt or other sales documentation (e.g. goods
subject to shelf life and obsolescence).

Miltenyi Biotec‘s warranty for this product only covers product issues caused by
defects in material or workmanship during normal use. It does not cover
product issues caused by any other reason, including but not limited to product
issues due to use of the product in a manner other than specifically described in
this manual, for example: inappropriate or improper use; incorrect assembly or
installation by an operator or a third party; reasonable wear and tear; negligent
or incorrect operation, handling, storage, servicing, or maintenance;
97
 non-adherence to the operating instructions; unauthorized modification of or
to any part of this product; or use of inappropriate consumables, accessories, or
work materials.

Miltenyi Biotec‘s warranty does not cover products sold AS IS or WITH ALL
FAULTS or consumables. Nothing herein should be construed as constituting an
additional warranty.

Miltenyi Biotec must be informed immediately if a claim is made under such

warranty. If a material or manufacturing defect occurs within the warranty
period, Miltenyi Biotec will take the appropriate steps to restore the full usability
of the instrument.

Limitation on damages
Miltenyi Biotec shall not be liable for any incidental or consequential
damages for breach of any express or implied warranty or condition on
this product.

Some countries/states or jurisdictions do not allow the exclusion or limitation of

incidental or consequential damages, so the above limitations or exclusions may
not apply to you. This warranty statement gives you specific legal rights and you
may have other rights which vary from state to state or jurisdiction to
jurisdiction.

8.2 Trademarks
CentriCult, CliniMACS, CliniMACS Prodigy, MACS, the Miltenyi Biotec logo,
PepTivator, and TexMACS 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.

98
APPENDIX
Guidance and manufacturer’s declaration
on electromagnetic compatibility

CliniMACS Prodigy® manufactured until 2018

EMC compliance with IEC 60601-1-2:2007 (Third Edition) has been attested for
the CliniMACS Prodigy® and the provided accessories (see Table 4.3, excluding
the optional accessories). The use of other power cables may result in increased
electromagnetic emissions or decreased immunity of the CliniMACS Prodigy. If
the provided power cable is missing, contact Miltenyi Biotec Technical Support.

Guidance and manufacturer’s declaration – Electromagnetic emissions

The CliniMACS Prodigy is intended for use in the electromagnetic environment specified below.
The customer or the user of the instrument should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment guidance

RF Emissions Group 1 The instrument uses RF energy only for its
CISPR 11 internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.

RF Emissions Class B The instrument is suitable for use in all

CISPR 11 establishments, including domestic
establishments and those directly connected
Harmonic emissions Class A to the public low voltage power supply
IEC 61000-3-2 network that supplies buildings used for
domestic purposes.
Voltage fluctuations/ Complies
Flicker emissions
IEC 61000-3-3
Table A.1: Guidance and manufacturer’s declaration – Electromagnetic emissions (manufactured until 2018)

The instrument should not be used adjacent to or stacked with other equip­
ment. If adjacent or stacked use is necessary, the instrument should be ob­­­-
served to verify normal operation in the configuration in which it will be used.
99
 Guidance and manufacturer’s declaration – Electromagnetic immunity
The CliniMACS Prodigy is intended for use in the electromagnetic environment specified
below. The customer or the user of the instrument should assure that it is used in such an
environment.

IEC 60601 Compliance Electromagnetic environment

Immunity test
Test level level guidance
Electrostatic ±6 kV contact ±6 kV contact Floors should be wood, concrete,
discharge (ESD) or ceramic tile. If floors are
IEC 61000-4-2 ±8 kV air ±8 kV air covered with synthetic material,
the relative humidity should be at
least 30%.

Electrical fast ±2 kV for ±2 kV for Mains power quality should be

transient/Burst power supply power supply that of a typical commercial or
IEC 61000-4-4 lines lines hospital environment.

±1 kV for ±1 kV for
input/output input/output
lines lines

Surge ±1 kV line(s) to ±1 kV line(s) to Mains power quality should be

IEC 61000-4-5 line(s) line(s) that of a typical commercial or
hospital environment.
±2 kV line(s) to ±2 kV line(s) to
earth earth

Voltage dips, <5% UT <5% UT Mains power quality should be

short (>95% dip in (>95% dip in that of a typical commercial or
interruptions UT) for UT) for hospital environment.
and voltage 0.5 cycle 0.5 cycle
variations on If the user of the instrument
power supply 40% UT 40% UT requires continued operation
input lines (60% dip in UT) (60% dip in UT) during power mains interrup­
IEC 61000-4-11 for 5 cycles for 5 cycles tions, it is recommended that the
instrument is be powered from an
70% UT 70% UT uninterruptible power supply or a
(30% dip in UT) (30% dip in UT) battery.
for 25 cycles for 25 cycles

<5% UT <5% UT
(>95% dip in (>95% dip in
UT) for 5 s UT) for 5 s

Power frequency 3 A/m 3 A/m Power frequency of magnetic

(50/60 Hz) fields should be at levels
magnetic field characteristic of a typical location
IEC 61000-4-8 in a typical commer­cial or
hospital environment.

NOTE: UT is the a.c. mains voltage prior to application of the test level.
Table A.2: Guidance and manufacturer’s declaration – Electromagnetic immunity (manufactured until 2018)

100
 Guidance and manufacturer’s declaration – Electromagnetic immunity
The CliniMACS Prodigy is intended for use in the electromagnetic environment specified
below. The customer or the user of the instrument should assure that it is used in such an
environment.

IEC 60601 Compliance Electromagnetic environment

Immunity test
Test level level guidance
Conducted RF 3 Vrms 3 Vrms Portable and mobile RF
IEC 61000-4-6 150 kHz to communications equipment
80 MHz should be used no closer to any
part of the instrument, including
Radiated RF 3 V/m 3 V/m cables, than the recommended
IEC 61000-4-3 80 MHz to separation distance calculated
2.5 GHz from the equation applicable to
the frequency of the transmitter.

Recommended separation
distance
d = 1.2 √P
d = 1.2 √P 80 MHz to 800 MHz
d = 2.3 √P 800 MHz to 2.5 GHz
where P is the maximum output
power rating of the transmitter in
watts (W) according to the
transmitter manufacturer and d is
the recommended separation
distance in meters (m). Field
strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey a,
should be less than the
compliance level in each
frequency range b. Interference
may occur in the vicinity of
equipment marked with the
following symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
the instrument is used exceeds the applicable RF compliance level above, the instrument should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the instrument.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Table A.3: Guidance and manufacturer’s declaration – Electromagnetic immunity (manufactured until 2018)

101
 Recommended separation distances between portable and mobile RF
communications equipment and the CliniMACS Prodigy
The CliniMACS Prodigy is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the instrument can
help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters including RFID readers),
and the instrument according to the maximum output power of the communications
equipment, as recommended below.

Rated maximum
Separation distance according to frequency
output power of
of transmitter (m)
transmitter (W)
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
d = 1.2 √P d = 1.2 √P d = 2.3 √P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and people.
Table A.4: Recommended separation distances (manufactured until 2018)

102
CliniMACS Prodigy® manufactured as of 2019
EMC compliance with IEC 60601-1-2:2014 (Edition 4) has been attested for the
CliniMACS Prodigy® and the approved accessories (see Table 4.3). The use of
other power cables may result in increased electromagnetic emissions or
decreased immunity of the CliniMACS Prodigy. If the provided power cable is
missing, contact Miltenyi Biotec Technical Support.

Guidance and manufacturer’s declaration – Electromagnetic emissions

The CliniMACS Prodigy is intended for use in the electromagnetic environment specified
below. The customer or the user of the instrument should assure that it is used in such an
environment.

Emissions test Compliance

RF Emissions Group 1
CISPR 11/32

RF Emissions Class A
CISPR 11/32

Harmonic emissions Class A

IEC 61000-3-2

Voltage fluctuations/Flicker emissions Complies

IEC 61000-3-3
Table A.5: Guidance and manufacturer’s declaration – Electromagnetic emissions (manufactured as of 2019)

Use of this instrument adjacent to or stacked with other equipment

should be avoided because it could result in improper operation. If such
use is necessary, this equipment and the other equipment should be
observed to verify that they are operating normally.

Based on technical limitations of the internal power supply voltage, inter­

ruptions on power supply input lines for longer than 10 ms may lead to
cessation of the separation process (power failure). The separation process
cannot be resumed after a power failure. It is recommended that the instrument
is powered from an uninterruptible power supply or a battery that starts within
10 ms.

103
 Guidance and manufacturer’s declaration – Electromagnetic immunity
The CliniMACS Prodigy is intended for use in the electromagnetic environment specified
below. The customer or the user of the instrument should assure that it is used in such an
environment.

Immunity test IEC 60601 Test level Compliance level

Electrostatic discharge ±8 kV contact discharge ±8 kV contact discharge
(ESD) ±2 kV, ±4 kV, ±8 kV, ±15 kV ±2 kV, ±4 kV, ±8 kV, ±15 kV
IEC 61000-4-2 air discharge air discharge

Electrical fast transients ±2 kV 100 kHz repetition ±2 kV 100 kHz repetition

(Bursts) frequency frequency
IEC 61000-4-4 Power supply lines Power supply lines
±1 kV 100 kHz repetition ±1 kV 100 kHz repetition
frequency frequency
Input/output lines Input/output lines

Surges ±0.5 kV, ±1 kV line to line ±0.5 kV, ±1 kV line to line

IEC 61000-4-5 ±0.5 kV, ±1 kV, ±2 kV line ±0.5 kV, ±1 kV, ±2 kV line
to ground to ground

Voltage dips, 0% UT during 0.5 cycle 0% UT during 0.5 cycle

interruptions and @ 0°, 45°, 90°, 135°, 180°, 225°, @ 0°, 45°, 90°, 135°, 180°, 225°,
variations 270°, 315° 270°, 315°
IEC 61000-4-11 0% UT during 1 cycle and 0% UT during 1 cycle and
70% UT during 25/30 cycles 70% UT during 25/30 cycles
(single phase) @ 0° (single phase) @ 0°
0% UT during 250/300 cycle

Rated power frequency 30 A/m 50 Hz or 60 Hz 30 A/m 50 Hz or 60 Hz

magnetic field
IEC 61000-4-8

Conducted disturbances 3 V (0.15 MHz to 80 MHz) 3 V (0.15 MHz to 80 MHz)

induced by RF fields 6 V in ISM bands between 6 V in ISM bands between
IEC 1000-4-6 0.15 MHz and 80 MHz 80% 0.15 MHz and 80 MHz 80%
AM @ 1 kHz AM @ 1 kHz

Radiated RF EM fields 3 V/m (80 MHz–2.7 GHz) 80% 3 V/m (80 MHz–2.7 GHz) 80%
IEC 61000-4-3 AM @ 1 kHz AM @ 1 kHz

Proximity fields from RF See table below: See table below:

wireless communication Specifications for immunity Specifications for immunity
equipment to RF wireless to RF wireless
IEC 61000-4-3 communication equipment communication equipment
Table A.6: Guidance and manufacturer’s declaration – Electromagnetic immunity (manufactured as of 2019)

104
 Guidance and manufacturer’s declaration – Electromagnetic immunity to
RF wireless communication equipment
Test Immunity
Band Maximum Distance Compliance
Frequency Service Modulation Test Level
(MHz) Power (W) (m) Level (V/m)
(MHz) (V/m)

385 380 TETRA 400 Pulse 1.8 0.3 27 27

– modulation
390 18 Hz

450 430 GMR S460, FRS FM 2 0.3 28 28

– 460 ±5 kHz
470 deviation
1 kHz sine

710 704 LTE Band 13, 17 Pulse 0.2 0.3 9 9

745 – modulation
780 787 217 Hz

810 800 GSM 800/900, Pulse 2 0.3 28 28

870 – TETRA 800, modulation
930 960 iDEN 820, 18 Hz
CDMA 850, LTE
Band 5

1720 1700 GSM 1800; Pulse 2 0.3 28 28

1845 – CDMA 1900; modulation
1970 1990 GSM 1900; 217 Hz
DECT; LTE
Band 1, 3, 4,
25; UMTS

2450 2400 Bluetooth, Pulse 2 0.3 28 28

– WLAN, 802.11 modulation
2570 b/g/n, 217 Hz
RFID 2450,
LTE Band 7

5240 5100 WLAN 802.11 Pulse 0.2 0.3 9 9

5500 – a/n modulation
5785 5800 217 Hz
Table A.7: Guidance and manufacturer’s declaration – Electromagnetic immunity to RF wireless
communication equipment (manufactured as of 2019)

Degradation of the performance of this equipment. Degradation of the

performance of this equipment if portable RF communications
equipment is used in close proximity to any part of the instrument.
Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than
30 cm (12 inches) to any part of the instrument, including cables specified
by the manufacturer.

105
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