Miltenyi Biotec CliniMACS User Manual

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CliniMACS® Workbench

User Manual

For U.S. CAUTION:

Clinical Research System Limited by Federal (or United States) Law to Investigational

Use or under an FDA Approval

Version 1

Original instructions

Table of Contents

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Summary of Contents for Miltenyi Biotec CliniMACS

Page 1 CliniMACS® Workbench User Manual For U.S. CAUTION: Clinical Research System Limited by Federal (or United States) Law to Investigational Use or under an FDA Approval Version 1 Original instructions...
Page 2 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.
Page 3 CliniMACS® Workbench User Manual Issued: 2022-06 210-003-200/02 For U.S. distributed by: Miltenyi Biotec B.V. & Co. KG Miltenyi Biotec Inc. Friedrich-Ebert-Straße 68 2303 Lindbergh Street 51429 Bergisch Gladbach Auburn, CA 95602 Germany Miltenyi Biotec Technical Support +49 2204 8306-3803 technicalsupport@miltenyi.com...
Page 5 Essential information This user manual provides instructions, warnings, precautions, and other important information for the use of the CliniMACS Workbench. Further safety information regarding the operation the CliniMACS Prodigy® System is provided in the CliniMACS Prodigy User Manual (Instrument). Equipment safety may be compromised. Equipment safety may be compromised if the instrument is not used according to the manufacturer’s...
Page 7: Table Of Contents
Table of contents Introduction General information Service information 1.2.1 CliniMACS Workbench information 1.2.2 Technical support Glossary Graphical depiction Glossary of symbols and terms Important safety information Safety instructions 3.1.1 Usage and installation 3.1.2 Hazards of electric shock and spread of fire 3.1.3...
Page 8 Table of contents (continued) The CliniMACS Workbench Regulatory information The CliniMACS Workbench within the CliniMACS Prodigy Cell & Gene Therapy Manufacturing System 4.2.1 Intended use 4.2.2 Compliance Technical data Components 4.4.1 Accessory power outlet 4.4.2 Main switch 4.4.3 Brake pedal 4.4.4...
Page 9 Table of contents (continued) The CliniMACS Workbench within the CliniMACS Prodigy Cell & Gene Therapy Manufacturing System System components Additional materials and equipment Limitation Warnings and precautions regarding the process Troubleshooting Legal notes Limited warranty Trademarks EU/EC Declaration of conformity...
Page 11: Introduction
The CliniMACS Workbench is a movable workbench specifically designed for the CliniMACS Prodigy and its accessories. The CliniMACS Workbench enables the user to place the CliniMACS Prodigy in a flexible and stable way, with the possibility to establish power, data, alarm, and gas connections via the ceiling of the facility environment.
Page 12: Service Information
Refer to these numbers when requesting information about the instrument or when requesting instrument service. Catalogue no. (REF): Serial no. (SN): 1.2.2 Technical support For information about the instrument and its components, contact Miltenyi Biotec Technical Support: Miltenyi Biotec B.V. & Co. KG Friedrich-Ebert-Straße 68 51429 Bergisch Gladbach...
Page 13: Glossary
Glossary 2.1 Graphical depiction The following chart depicts the panels used in this user manual to inform the user about potential risks if the outlined warnings and precautions are not followed. The hazard level classifies the hazard, as described below. The level, type, and source of the hazard, as well as potential consequences, prohibitions, and measures are indicated as follows.
Page 14: Glossary Of Symbols And Terms
2.2 Glossary of symbols and terms An overview of symbols and terms used for the CliniMACS Prodigy System is provided in the CliniMACS Prodigy User Manual (Instrument). The glossary of symbols depicts the symbols used for labeling of the CliniMACS products.
Page 15: Important Safety Information
(including, without limitation, the safety information in this chapter) and in any safety-related recommendations issued by Miltenyi Biotec. Pay special attention to all warnings on the CliniMACS Prodigy and CliniMACS Workbench or provided with consumables and accessories. The operator must adhere to all instructions and procedures at all times during the operation of the instrument, confirming that all safety information, warnings, precautions, and instructions are observed.
Page 16 • Never use the instrument with consumables, parts, or accessories other than those approved by Miltenyi Biotec, to ensure safe and proper operation of the instrument. Note: The use of consumables, parts, or accessories not expressly approved by Miltenyi Biotec could void your warranty and/or invalidate the authority to operate this instrument under applicable regulations.
Page 17 Failure to comply with the safety information, warnings, precautions, and instructions in the CliniMACS Workbench User Manual (and in other safety related publications issued by Miltenyi Biotec for use with your instrument) could lead to improper or incorrect use, handling or...
Page 18: Safety Instructions
3.1 Safety instructions In the event of unexpected process abortion or messages on the screen of the CliniMACS Prodigy that advises the operator to contact technical support, immediately contact the Miltenyi Biotec Technical Support. If secure operation is no longer possible, immediately switch off the instrument using the main switch and contact Miltenyi Biotec Technical Support or an authorized local Miltenyi Biotec Service Provider.
Page 19: Mechanical Hazards
Contact Miltenyi Biotec Technical Support. The CliniMACS Workbench is a Protection Class I instrument and must be connected to a grounded outlet. Use the instrument only with the specified voltage given in the technical specifications. Do not connect any electrical device with more than 500 W to the accessory power outlet of the instrument.
Page 20: Gas Hazards
1 bar to max 2.5 bar for each gas may be applied. If the gas connections to the CliniMACS Prodigy are removed, gas may emit from the system. Do not remove the gas connections from the CliniMACS Prodigy. In case the gas...
Page 21: Servicing And Transport
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.
Page 22: Position Of Safety Symbols
3.2 Position of safety symbols Notice the positions of the safety symbols (see Figure 3.1) on the instrument and keep them in an easily readable state. The safety labels must be kept clean and legible. Note: Figure 3.1 shows the position of the general warning sign on the upper surface of the instrument.
Page 23: The Clinimacs Workbench
(like transfection, 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 U.S. CAUTION: Clinical Research System Limited by Federal (or United States) Law to Investigational Use or under an FDA Approval For regulatory status in countries outside Europe and the U.S., contact the...
Page 24: The Clinimacs Workbench Within The Clinimacs Prodigy Cell & Gene Therapy Manufacturing System
The CliniMACS Workbench is intended as a movable workbench for the CliniMACS Prodigy only, optional in combination with the CliniMACS Electroporator. The CliniMACS Workbench is for ex vivo cell processing only. It is intended to be used by professional users in a GMP environment.
Page 25: Compliance
The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012 Supply of Machinery (Safety) Regulations 2008 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.
Page 26: Technical Data
Do not use the instrument outside its specifications. Risk of injury or damage. The installation of the instrument, and mounting of CliniMACS Prodigy on the CliniMACS Workbench must be performed by an authorized local Miltenyi Biotec Service Provider only. Technical data (general)
Page 27 Humidity: 10% to 75% relative humidity, non-condensing Altitude: <2,000 meters above sea level Storage conditions Room temperature Avoid condensing conditions. Table 4.1: Technical data (general) of the CliniMACS Workbench Technical data (electrical) Input voltage 208–240 VAC, 45–65 Hz 100–127 VAC, 45–65 Hz Uninterruptible „Alpha pinnacle plus 3,000 –...
Page 28: Components
Workbench Large models have a larger table top to allow the positioning of the CliniMACS Electroporator in addition to the CliniMACS Prodigy. All other components shown in Figure 4.1 and Figure 4.2 are identical for the CliniMACS Workbench and the CliniMACS Workbench Large.
Page 29 The front-side view is shown in Figure 4.1. Connector for the Table top Connectors to the CliniMACS Prodigy central supplies/ (not shown) power outlet Hooks Handle Storage compartments Main switch Key for the cover of the UPS compartment Left-side Right-side...
Page 30: Accessory Power Outlet
UPS automatically. Open the right cover of the UPS compartment to access the UPS and push the ON/OFF button on the UPS for at least 3 seconds to turn it back on (see manual of the UPS). Contact Miltenyi Biotec Technical Support for assistance.
Page 31: Brake Pedal
On position (1) Off position (0) Figure 4.4: Main switch 4.4.3 Brake pedal The brake pedal is positioned on the right side of the instrument (see Figure 4.2). The different brake pedal positions are important for the handling of the instrument.
Page 32: Hooks
CliniMACS Prodigy. Before moving the instrument perform a shutdown of the CliniMACS Prodigy and detach any disposables. The movement of the instrument must only be performed on plane and smooth surfaces to avoid any vibrations. The movement within the cleanroom should be restricted as much as possible.
Page 33: Central Supplies
It consists of a power, data, gas, and network module. Refer to the instructions provided with the ceiling socket. The correct connections between the CliniMACS Prodigy and the ceiling socket are shown and described in Figure 4.6 on page 32.
Page 34 Note: Pin 2 of the alarm connector module of the ceiling socket corresponds to Pin 7 of the alarm connector of the CliniMACS Prodigy (see also the wiring details of the relay circuit in section “Connector panel” within the user manual of the...
Page 35: Storage Compartment
Limited duration of power supply by the UPS. The UPS can supply power to the CliniMACS Prodigy during its full power consumption for about max. 15 minutes. If the CliniMACS Prodigy is only powered through the UPS, the separation process should not be resumed and the cellular material remaining in the CliniMACS Prodigy Tubing Set should be immediately collected.
Page 36: Connectors To The Clinimacs Prodigy
The CliniMACS Workbench provides power, alarm, network, and gas connections to the CliniMACS Prodigy. The connection between the CliniMACS Workbench and the CliniMACS Prodigy is established by an authorized local Miltenyi Biotec Service Provider during installation of the CliniMACS Workbench.
Page 37: Connection Of The Central Supplies To The Ceiling Socket
4.5.2 Connection of the central supplies to the ceiling socket In order to (re)install the central supplies to a ceiling socket, make sure to securely lock the latch of the ceiling socket on the central supplies to fix the connectors (see Figure 4.8).
Page 38: Placement Of The Clinimacs Prodigy Supplementary Bag
CliniMACS Prodigy Supplementary Bag should be placed within the Supplementary Bag compartment underneath the benchtop of the instrument (see Figure 4.9). The CliniMACS Prodigy Supplementary Bag has to be inserted from the side of the Supplementary Bag compartment as shown in Figure 4.9.
Page 39: Positioning
4.5.4 Positioning The CliniMACS Workbench must only be used in combination with the CliniMACS Prodigy and accessories related to the application (see Figure 4.10 and Table 4.1 on page 25 and Table 4.2 on page 25). Figure 4.10: CliniMACS Prodigy installed on an exemplary CliniMACS Workbench 4.5.5 Transport...
Page 40: Cleaning And Disinfection
Miltenyi Biotec Service Provider. Routine and preventative maintenance procedures should be conducted by the manufacturer’s authorized service personnel at least once a year. Contact the authorized local Miltenyi Biotec Service Provider for Miltenyi Biotec’s Instrument service and support arrangements.
Page 41: Disposal
4.8 Disposal Contact Miltenyi Biotec Technical Support for final disposal. The instrument 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.
Page 43: The Clinimacs Workbench Within The Clinimacs Prodigy Cell & Gene Therapy Manufacturing System
Prodigy Cell & Gene Therapy Manufacturing System 5.1 System components The different applications running on the CliniMACS Prodigy require the use of specific CliniMACS Materials as well as additional materials and equipment as described in the CliniMACS Prodigy User Manual for the respective application.
Page 44: Limitation
5.3 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. 5.4 Warnings and precautions regarding the process Risk of process failure or damage to the instrument.
Page 45: Troubleshooting
Troubleshooting In any case of malfunctioning of the instrument or process failure, contact the Miltenyi Biotec Technical Support team at: +49 2204 8306-3803 technicalsupport@miltenyi.com Visit www.miltenyibiotec.com for local Miltenyi Biotec Technical Support contact information.
Page 47: Legal Notes
7.1 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.
Page 48: Trademarks
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.
Page 49: Eu/Ec Declaration Of Conformity
The declaration of conformity refers to the machinery identified as follows: Description: Laboratory equipment Model: CliniMACS Workbench with central supplies, HV-UPS The machinery complies with all essential requirements of the following directives:...
Page 50: Declaration Of Conformity
The declaration of conformity refers to the machinery identified as follows: Description: Laboratory equipment Model: CliniMACS Workbench with central supplies, HV-UPS The machinery complies with all essential requirements of the following legislations:...
Page 51: Appendix
If the provided connecting cables are missing, contact Miltenyi Biotec Technical Support. EMC compliance with IEC 60601-1-2:2014 (Edition 4) has been attested for the instrument.
Page 52 Guidance and manufacturer’s declaration – Electromagnetic immunity The instrument 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 60601-1-2 Test level Compliance level electrostatic discharge ±8 kV contact discharge...
Page 53 Guidance and manufacturer’s declaration – Electromagnetic immunity to RF wireless communication equipment Test Band Service Modu- Maxi- Dis- Immu- Com- Fre- (MHz) lation tance nity pli- quency Power Test ance (MHz Level Level (V/m) (V/m) 380– TETRA 400 Pulse modula- tion 18 Hz 430–...
Page 54 For the CliniMACS Prodigy System components including the CliniMACS Prodigy and the CliniMACS Workbench, special care needs to be taken for sensitive parts equipped with sensors, data interfaces or camera systems (e.g., CentriCult Unit, peristaltic pump, liquid sensors, or monitor with touchscreen (refer to the corresponding CliniMACS Prodigy User Manual)).
Page 55 Miltenyi Biotec provides products and services worldwide. Visit www.miltenyibiotec.com/local to find your nearest Miltenyi Biotec contact. CliniMACS, CliniMACS Prodigy, MACS, and the Miltenyi Biotec logo are registered trademarks or trademarks of Miltenyi Biotec B.V. & Co. KG and/or its affiliates in various countries worldwide. Copyright © 2022 Miltenyi Biotec and/or its affiliates. All rights reserved.