Miltenyi Biotec MultiMACS X User manual

MultiMACS™ X
User manual

Copyright © 2020 Miltenyi Biotec and/or its affiliates. All rights reserved.
No part of this user manual 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 MultiMACS™ X may make copies solely for purposes of training personnel in the use and servicing of
the unit within their business or organization. Maximal care has been taken by Miltenyi Biotec in the preparation of this user manual. However, Miltenyi
Biotec shall not be liable for any technical or editorial errors or omissions contained herein or for incidental or consequential damages in connection with
the furnishing, performance, or use of this document. The information in this document is provided “as is” without warranty of any kind, and is subject to
change without notice. MACS, MultiMACS, and the Miltenyi Biotec logo are either registered trademarks or trademarks of Miltenyi Biotec 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. Unless otherwise specifically indicated, Miltenyi Biotec products and services are for research use only and not for therapeutic
or diagnostic use.

MultiMACS™ X
User manual
Original instructions
Miltenyi Biotec B.V. & Co. KG
Friedrich-Ebert-Straße 68
51429 Bergisch Gladbach
Germany
Phone [phone]
Fax [phone]
[e-mail]
www.miltenyibiotec.com

Read the chapter Important safety information and all
other information in this user manual before using the
instrument
Before using the MultiMACS™ X, read the chapter Important safety information and all other information
contained in this user manual, including any safety and operating instructions. Pay special attention to all
warnings displayed on the instrument. Failure to read and follow these guidelines could lead to improper or
incorrect usage and result in damage to the instrument. Improper usage could also cause severe personal injury,
death, unpredictable results, instrument malfunction, and premature wear to components shortening the
lifetime of the instrument. Such actions may void your warranty. Keep the user manual and any other safety and
operating instructions provided with the instrument in a safe place accessible to all users for future reference.
If you have a serious concern regarding the safe use of your instrument, contact your authorized Miltenyi Biotec
service provider or call Miltenyi Biotec Technical Support.
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Content
Important safety information 7
Wichtige Sicherheitshinweise 15
Información importante de seguridad 25
Informations de sécurité importantes 33
1 Introduction 41
2 Installation 43
2.1 Components included in the delivery 43
2.2 Consumables 44
2.3 Accessories 45
3 Components of the MultiMACS X 47
3.1 The robotic arms of the MultiMACS X 48
3.1.1 The liquid handling arm (LiHa) 48
3.1.2 The robotic manipulator arm (RoMa) 48
3.2 Liquid containers 48
3.3 MultiMACS Cell24 Separator X, MACS Elution Station X, and MACS Elution Chamber X 48
3.4 The waste unit 49
3.5 Storage hotels 49
3.6 MultiMACS X Chill Racks 49
3.6.1 Reagent racks 49
3.6.2 Sample racks 49
3.7 The MultiMACS X work area 50
3.8 Control elements 50
3.8.1 Robot ON/OFF button 50
3.8.2 Pause button 50
3.8.3 Computer ON/OFF button 50
3.8.4 The status lamp 50
3.9 Options for customization 51
3.9.1 Steel needles 51
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3.9.2 Hood integration 51
4 Startup and shutdown 53
4.1 Switch on the instrument 53
4.2 Log in 53
4.3 The user interface 55
4.4 Shutting down the instrument 56
5 Running a separation 57
5.1 Start a program 57
5.2 Quickstart 63
5.2.1 Select a program from the quickstart list 63
5.2.2 Add a program from the quickstart list 64
5.2.3 Remove programs from the quickstart list 64
6 Maintenance 67
6.1 Daily maintenance tasks 67
6.1.1 Perform a daily wash 67
6.1.2 Exchange the DiTi waste bag 69
6.1.3 Cleaning and inspection of DiTi cones (LiHa) 69
6.1.4 Tightening of the fixed tip lock nut (re-usable steel needles) 70
6.1.5 Tightening of syringe and plunger lock screws 70
6.1.6 Checking for leaks 71
6.1.7 Cleaning fixed tips (Re-usable steel needles) 71
6.1.8 Checking fixed tips for damage 71
6.2 Weekly maintenance tasks 72
6.2.1 Cleaning the worktable 72
6.2.2 Cleaning the acrylic safety panel 72
6.2.3 Cleaning the liquid containers 72
6.2.4 Cleaning the DiTi waste and wash station unit 72
6.2.5 System decontamination 74
6.3 Corrective maintenance 75
6.3.1 Initialization of the MultiMACS Cell24 Separator X in case of a power failure 75
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6.3.2 Gripper check 75
6.4 Cleaning agents 75
7 Troubleshooting 77
7.1 Power failure 77
7.2 Improper initialization of the RoMa 77
7.3 Leakage of the liquid system 78
8 Technical data and specifications 79
8.1 Technical specifications of the MultiMACS X 79
8.2 Technical specifications of the MultiMACS Cell24 Separator X 82
8.3 Technical specifications of the MACS Elution Station X 82
8.4 EC/EU Declaration of Conformity 83
9 Technical support 85
10 Limited warranty 87
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EN
Important safety information
The MultiMACS X is designed for safe use when installed correctly, operated by professional laboratory
personnel, operated in accordance with general safety practices and the instructions in this user manual.
Warnings and precautions
The guidelines in this section explain the potential risk associated with operating this instrument and provide
important supplemental safety information to minimize the risks. Follow the instructions carefully to protect
yourself, others, and the equipment from potential hazards and create a safe work environment. Use this
instrument only as specified by the manufacturer to avoid damage of equipment and injury to personnel.
Always follow local working area safety instructions and laboratory policies as well as standards for health,
safety and prevention of accidents. Contact the local authorities governing electrical power supply, building
constructions, maintenance, or safety for more information about the safe installation and operation of the
instrument.
Hazard levels
Signal words are used to warn against hazardous situations and property damages. The following signal words
are used in this user manual.
or WARNING! indicates a hazardous situation that could result in serious injury or death.
or CAUTION! indicates a hazardous situation that could result in minor or moderate injury. It is also used
to warn against unsafe practices.
Safety symbols
SAFETY ALERT. RISK OF DANGER. THE DOCUMENTATION NEEDS TO BE CONSULTED IN ALL CASES
WHERE THIS SAFETY SYMBOL IS USED, IN ORDER TO FIND OUT THE NATURE OF THE POTENTIAL
HAZARD AND ANY ACTIONS THAT HAVE TO BE TAKEN.
RISK OF ELECTRIC SHOCK.
STRONG MAGNETIC FIELD.
PERSONS CARRYING PACEMAKERS OR ELECTRONIC MEDICAL IMPLANTS MUST MAINTAIN DISTANCE.
RISK OF CRUSHING AND SHEARING OF BODILY PARTS.
HAZARDOUS OPTICAL RADIATION.
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IMPORTANT SAFETY INFORMATION
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BIOHAZARD. RISK OF CONTAMINATION IF POTENTIALLY DANGEROUS BIOLOGICAL MATERIAL IS
USED.
PROTECTIVE CONDUCTOR TERMINAL. SYMBOL IS ATTACHED ON THE INSIDE OF THE INSTRUMENT.
INFORMATION FOR SERVICE PERSONNEL.
DISTURBANCE OF FUNCTIONS BY ELECTROMAGNETIC RF WAVES. DO NOT USE A CELLULAR PHONE.
FUSE.
WEEE.
READ THE USER MANUAL BEFORE USING THE INSTRUMENT.
DISCONNECT MAINS PLUG FROM ELECTRICAL OUTLET.
MANUFACTURER.
ORDER NUMBER.
TYPE NUMBER.
SERIAL NUMBER.
EUROPEAN CONFORMITY APPROVAL.
NRTL CERTIFICATION MARK: PRODUCT MEETS CONSENSUS-BASED STANDARDS OF SAFETY,
REQUIRED BY THE OCCUPATIONAL SAFETY/HEALTH ADMINISTRATION (OSHA), DETERMINED BY THE
NATIONALLY RECOGNIZED TESTING LABORATORIES (NRTL) TÜV SÜD.
Safety labels
Notice the hazard points and safety symbols of the instrument.
• Keep safety labels and safety markings clean and legible.
• Inspect the safety labels and safety markings regularly and replace them if they are not legible or identifiable
from a safe viewing distance.
• Contact Miltenyi Biotec for replacement labels.
IMPORTANT SAFETY INFORMATION
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Figure 1: Hazard areas and safety symbols on the front of the MultiMACS X.
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Figure 2: Hazard areas and safety symbols on the front of the MultiMACS X, safety panel open.
Figure 3: Hazard areas and safety symbols on the rearside of the MultiMACS X.
IMPORTANT SAFETY INFORMATION
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General safety instructions
If the instrument is not working properly and/or the displayed instructions or messages advise you to contact
technical support, safe operation of the instrument is not longer possible. Immediately switch off and unplug
the instrument from the power outlet and contact an authorized Miltenyi Biotec service provider or Miltenyi
Biotec Technical Support.
Electricity and fire hazards
Potential risks arising from electrical devices include electric shock, short, and overheating.
Electric shock may lead to severe personal injury or death. An electric short and overheating
may lead to the spread of fire. Electronic equipment might emit sparks, which could ignite combustible
vapors or material resulting in explosion or fire. Do not use the instrument in areas classified as hazardous
locations; for example, in oxygen-laden environments.
The housing of the instrument is designed to reduce the risks of electric shock, electric short, and spread of fire.
Do not remove or penetrate any cover. Only authorized personnel must remove the other covers of the
instrument. Never push an foreign object through an opening into the instrument. Do not use the instrument if
lit has been opened or disassembled
lit has been dropped or damaged
lit has damaged or broken parts
lit has a damaged power cable
lan object has been entered through the ventilation slots
lan object has been dropped into the instrument
If flames or smoke appear, immediately switch off the power supply, unplug the instrument from the electrical
outlet, and contact an authorized Miltenyi Biotec service provider or Miltenyi Biotec Technical Support.
The instrument is intended for indoor use only. If fluids enter the instrument, it may lead to electric
shorts, electric shock, or fire. Take special care while handling liquids. Do not allow liquids to enter the
interior of the instrument. Protect the instrument against accidental spillages and splashes. Clean up spillages
immediately. Do not operate the instrument if liquids have spilled into the instrument. Do not use the
instrument in a wet and damp location. Avoid areas with high humidity or condensation. Moving the
instrument from a cold environment – such as a cold room at 5°C – to room temperature may cause
condensation inside the instrument. In such cases, wait for the instrument to dehumidify before operating it.
Unplug the instrument from the electical outlet before cleaning, . Do not use liquid or aerosol cleaning agents;
always use a damp cloth.
Ensure adequate air circulation in the room when the instrument is operated. In the absence of adequate
circulation, ambient air may not cool the instrument to acceptable operating temperatures. Allow sufficient air
circulation around the instrument – at least 15 cm on all sides – during operation to ensure adequate cooling.
Do not place the instrument near radiators, heat registers, stoves, or other equipment (including amplifiers) that
generate heat. Protect the instrument from direct sunlight. Do not cover the slots and openings of the
instrument as these are provided for ventilation and protect the instrument from overheating. Do not place the
instrument in a built-in rack or similar confined spaces unless the space has been specifically designed to
provide proper ventilation. Follow the mounting instructions for the instrument.
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IMPORTANT SAFETY INFORMATION
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Ensure that the main switch as well as the plug of the power cable 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 cable
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 fits into a grounded power outlet only. This is a safety feature. Do not try to insert the plug into a non-
grounded power outlet. If you cannot insert the plug into the outlet, contact your local electrician to replace the
outlet. The instrument should only be operated from a power source that meets the specifications mentioned
on the product´s electrical ratings label. If you have questions about the type of power source to use, contact
your authorized Miltenyi Biotec service provider or local power company. Do not use extension cords or power
strips. Do not overload an electrical outlet.
Only the 2D code reader that was delivered with the instrument should be connected to the RS232/BCR port.
External laser devices connected to the RS232/BCR port have to comply with the standard IEC/TR 62471.
Strong magnetic field
The MultiMACS X is equipped with an extremely powerful magnet.
There is a risk of severe personal injury for persons carrying pacemakers, brain shunts, or
electronic medical implants.
Keep any magnetic information carriers (such as credit cards, magnetic tapes and floppy disks), any electronic
equipment (such as hearing aids, pacemakers, cerebral shunt, measuring and control instruments, computers,
and watches), and magnetizable tools and objects at a distance of at least 20 cm. These items may be affected
or damaged by the magnetic field.
Mechanical hazards
Keep fingers etc. away from all moving parts of the MultiMACS X to avoid crushing and
shearing injuries or damage to the instrument. Use the MultiMACS X only with the safety panel closed.
Do not open the safety panel while an application is running. The instrument is only running if the safety panel
is closed. This is a safety feature. Do not circumvent any safety device or measurement.
Do not obstruct the movement of the robotic arms and accessory hardware during operation. Keep fingers
away from all moving parts of the MultiMACS X. Do not adjust tubing while the instrument is in operation.
Always stop or abort a process before handling accessory hardware. Do not reach into the MultiMACS X through
any aperture on the instrument front side. Always open the front safety panel completely. A not completely
opened front safety panel might close automatically.
Fixed steel needle tips are sharp and can cause a hazard if using infected or contaminated biological material.
Always wear protective gloves if operating the instrument. Avoid touching the tips unless you need to clean
them.
Optical hazards
The instrument is equipped with a 2D code reader. The light-emitting diodes (LEDs) emit invisible light for
illuminating the reading area. According to the international standard IEC 62471, this lamp system is in the
Exempt risk group.
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Be careful of the path of the light beam or reflection from a mirrored surface. Take care during installation of
the instrument that the path of the light beam is not at the same height as the human eye during operation. Do
not allow water, oil, dust or other foreign substances to stick to the 2D code reader aperture window. This may
cause reading errors. Be sure to stop the laser emission before cleaning the scanner. Otherwise, exposure to the
light may cause eye injury. Use a soft, dry cloth to wipe any substances from the scanner. Do not use alcohol or
other cleaning substances.
Do not disassemble, modify, or remove the installed laser or LED radiation sources. The laser or
LED radiation sources do not automatically stop emitting when disassembled. Radiation of
disassembled units may lead to eye injuries.
Chemical and biological hazards
Depending on the biological material used, contamination or infection may lead to severe personal injury or
death. All clinical samples must be considered potentially infectious. If biohazardous material is or has
been used, the operator must choose and wear personal safety equipment as indicated in the
warnings and precautions for the particular substance. The above safety precaution also accounts for any
hazardous chemical, including toxic or corrosive chemicals, acidic, or radioactive substances, that may be
present in the sample. Wear protective gloves and clothing, as well as safety glasses to prevent contact of the
substance with skin and eyes. Also protect mouth and nose as aerosols might leak from the system. Defective or
inadequate safety equipment is hazardous. The instrument must be operated in a safety hood if hazardous or
unknown materials are being processed. If hazardous material has been used or spilled, care must be taken to
thoroughly decontaminate the instrument. It is strictly prohibited to continue to handle contaminated
accessories or parts of the instrument. Operate the instrument only with a properly installed waste bag holder.
Columns, plates, tubes and any other consumables that were in contact with biohazardous material must be
decontaminated before disposal. Liquid waste must be autoclaved or decontaminated using a disinfectant that
is appropriate for the specific pathogen, e.g., 10% bleach, isopropyl alcohol, or 70% ethanol. All liquid and solid
waste must be considered biohazardous and, therefore, must be handled taking universal laboratory
precautions. Waste disposal must be in accordance with any local regulations.
If using disposable tips, do not operate the instrument without the waste bag holder in place. If using reusable
steel tips, the waste container may contain potentially infectious material. Label the container properly and
dispose of the liquid waste in accordance with your local regulations.
Servicing, transport, and disposal
Unless otherwise specifically noted in this user manual or other Miltenyi Biotec documentation, do not
service the instrument yourself. Servicing and repair must be performed by qualified service personnel.
Improper or incorrect servicing or repair of the instrument can cause hazards to users, lead to unpredictable
results, cause instrument malfunctions or damage, as well as premature wear and tear and reduced life of the
instrument. It may also void your warranty.
When replacement or spare parts are required, ensure that the service provider uses only genuine Miltenyi
Biotec parts, or third-party parts specified and recommended by Miltenyi Biotec. Using unauthorized parts can
cause malfunctions 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 parts. After
completing any service or repair work, ensure that your authorized Miltenyi Biotec service provider performs all
safety checks as required by the repair procedure to ensure that the instrument is operating correctly.
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Only use options and upgrades recommended by Miltenyi Biotec. Inquire with your local Miltenyi
Biotec representative about Miltenyi Biotec's extensive instrument service and support arrangements, or refer to
miltenyibiotec.com/support.
The instrument should be transported with care in packaging specified by Miltenyi Biotec. Internal damage can
occur if the instrument is subjected to excessive vibration or is dropped. If the instrument needs to be shipped
back to the manufacturer for service, decontaminate the instrument to remove any hazardous material prior to
shipment. If you have questions regarding proper decontamination or shipment, contact Miltenyi Biotec
Technical Support for assistance.
Waste of Electrical and Electronic Equipment (WEEE) customer information
Please dispose of your end-of-life Miltenyi Biotec products in accordance with the applicable WEEE and
hazardous waste disposal legislation, which may differ by country or region.
Electrical and electronic equipment may contain hazardous substances which may have a serious detrimental
effect on the environment and/or human health. That is why all equipment must be specifically collected and
treated by designated waste facility centres and by qualified WEEE compliance schemes. By ensuring that you
dispose of your unwanted electrical and electronic equipment according to the applicable WEEE and hazardous
waste disposal legislation, you are helping to preserve our natural resources and protect human health.
Miltenyi Biotec is committed to protecting the environment. Miltenyi Biotec offers product end-of-life return
programs in many countries, and partners with licensed WEEE compliance schemes throughout the world.
Miltenyi Biotec lets you recycle your end-of-life Miltenyi Biotec equipment free of charge. The terms and
availability of this offer vary by geography because of differences in regulatory requirements. Note that,
depending on the type and use of your equipment, additional requirements may apply. For more information,
or if you wish to dispose of your end-of- life Miltenyi Biotec equipment, contact your local Miltenyi Biotec
representative or Miltenyi Biotec Technical Support.
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Wichtige Sicherheitshinweise
Der MultiMACS X ist für einen sicheren Betrieb ausgelegt, wenn das Gerät richtig installiert, von professionellem
Laborpersonal bedient und entsprechend der Sicherheitsrichtlinien und Anweisungen in diesem
Benutzerhandbuch eingesetzt wird.
Warn- und Sicherheitshinweise
Die Sicherheitsrichtlinien in diesem Kapitel erläutern die Gefahren, die sich aus dem Betrieb dieses Gerätes
ergeben können und enthalten wichtige zusätzliche Informationen wie diese Risiken zu minimieren sind.
Befolgen Sie diese Sicherheitshinweise sorgfältig um sich, andere und das Gerät vor möglichen Gefahren zu
schützen und ein sicheres Arbeitsumfeld zu schaffen. Um Sach- und Personenschäden zu vermeiden, benutzen
Sie das Gerät ausschließlich nach Angaben des Herstellers. Örtliche Arbeitsschutzbestimmungen,
Laborrichtlinien, Sicherheitsnormen und Unfallverhütungsvorschriften müssen jederzeit beachtet und
eingehalten werden. Wenden Sie sich für weitere Informationen zur Stromversorgung, Gebäudeinstallationen,
Wartung und Sicherheit für die Installation dieses Gerätes an die örtlichen Behörden und Ihren Stromversorger.
Gefahrenstufen
Es werden Signalwörter verwendet, um vor Gefahrensituationen und Sachschäden zu warnen. In diesem
Benutzerhandbuch werden die folgenden Signalwörter verwendet.
oder WARNUNG! weist auf eine gefährliche Situation hin, die zu schweren Verletzungen oder zum Tod
führen kann.
oder VORSICHT! weist auf eine gefährliche Situation hin, die zu geringfügigen oder mittelschweren
Verletzungen führen kann. Es wird auch verwendet, um auf unsichere Vorgehensweisen hinzuweisen.
Gefahrensymbole
WARNZEICHEN. GEFAHRENRISIKO. DIESES BENUTZERHANDBUCH MUSS IMMER KONSULTIERT
WERDEN, WENN DIESES WARNZEICHEN BENUTZT WIRD, UM MEHR ÜBER DIE MÖGLICHEN GEFAHREN
UND ENTSPRECHENDE HANDLUNGSANWEISUNGEN ZU ERFAHREN.
GEFAHR EINES STROMSCHLAGS.
STARKES MAGNETFELD.
PERSONEN MIT HERZSCHRITTMACHER ODER ELEKTRONISCHEN MEDIZINISCHEN IMPLANTATEN
MÜSSEN ABSTAND HALTEN.
QUETSCH- UND SCHERGEFAHR.
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GEFAHR DURCH OPTISCHE STRAHLUNG.
BIOLOGISCHE GEFÄHRDUNG. RISIKO DER KONTAMINATION, WENN MIT MÖGLICHERWEISE
GEFÄHRLICHEN BIOLOGISCHEN SUBSTANZEN GEARBEITET WIRD.
SCHUTZLEITERANSCHLUSS. DIESES SYMBOL IST INNERHALB DES GERÄTS ANGEBRACHT UND STELLT
EINEN HINWEIS FÜR DAS SERVICEPERSONAL DAR.
DISTURBANCE OF FUNCTIONS BY ELECTROMAGNETIC RF WAVES. DO NOT USE A CELLULAR PHONE.
SICHERUNG.
WEEE.
LESEN SIE DAS BENUTZERHANDBUCH VOR VERWENDUNG DES GERÄTES.
NETZSTECKER ZIEHEN.
HERSTELLER.
BESTELLNUMMER.
MODELLNUMMER.
SERIENNUMMER.
EUROPÄISCHES KONFORMITÄTSKENNZEICHEN.
NRTL-PRUFZEICHEN: DAS PRODUKT ENTSPRICHT DEN IM KONSENSVERFAHREN ERARBEITETEN
SICHERHEITSANFORDERUNGEN, WELCHE VON DER OCCUPATIONAL SAFETY/HEALTH
ADMINISTRATION (OSHA) GEFORDERT UND VON DER STAATLICH ANERKANNTEN PRUFSTELLE
(NATIONALLY RECOGNIZED TESTING LABORATORIES (NRTL)) TÜV SÜD GEPRUFT WURDEN.
Sicherheitskennzeichnungen
Beachten Sie die Gefahrenhinweise und Sicherheitssymbole des Gerätes.
• Halten Sie die Warnaufkleber und Sicherheitskennzeichnungen sauber und lesbar.
• Überprüfen Sie die Warnaufkleber und Sicherheitskennzeichnungen regelmäßig und ersetzen Sie diese, wenn
sie nicht mehr lesbar oder aus sicherer Entfernung nicht zu erkennen sind.
• Kontaktieren Sie Miltenyi Biotec, um Ersatzaufkleber zu erhalten.
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Figure 1: Gefahrenquellen und Gefahrensymbole auf der Vorderseite des MultiMACS X.
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Figure 2: Gefahrenquellen und Gefahrensymbole auf der Vorderseite des MultiMACS X, Sicherheitsklappe offen.
Figure 3: Gefahrenquellen und Gefahrensymbole auf der Rückseite des MultiMACS X.
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