Miltenyi Biotec 170-075-703, User Manual

Page 1: ...CliniMACS Formulation Unit 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 2 Original instructions...

Page 2: ...ec products and services are for research use only and not for therapeutic or diagnostic use Copyright 2022 Miltenyi Biotec and or its affiliates All rights reserved No part of this publication may be...

Page 3: ...S distributed by Miltenyi Biotec B V Co KG Friedrich Ebert Stra e 68 51429 Bergisch Gladbach Germany Miltenyi Biotec Inc 2303 Lindbergh Street Auburn CA 95602 USA Miltenyi Biotec Technical Support 49...

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Page 5: ...per operation of the CliniMACS Formulation Unit provided in this user manual including without limitation the safety information in chapter 3 Important safety information of this document and in the C...

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Page 7: ...14 3 1 1 Usage and installation 14 3 1 2 Hazards of electric shock and spread of fire 15 3 1 3 Mechanical hazards 17 3 1 4 Chemical and biological hazards 17 3 1 5 Servicing and transport 17 4 The Cli...

Page 8: ...ell Gene Therapy Manufacturing System 33 5 1 The CliniMACS Formulation Unit and CliniMACS Prodigy Cell Gene Therapy Manufacturing System components 33 5 2 Additional materials and equipment 33 5 3 Lim...

Page 9: ...ls 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 The CliniMACS Formulation Unit is...

Page 10: ...ation Record below the model and serial number located on the back of the CliniMACS Formulation Unit Refer to these numbers when requesting information about the instrument or when requesting instrume...

Page 11: ...otential consequences prohibitions and measures are indicated as follows Icons on the left side specify the risk Indicates a hazardous situation that if not avoided could result in death or serious in...

Page 12: ...nd 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 labelin...

Page 13: ...hout 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...

Page 14: ...strument is intended for the use in the professional facility healthcare environment The instrument is not intended to be used near active HF surgical equipment The customer or user should assure that...

Page 15: ...cable regulations 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 safe...

Page 16: ...improper operation Electrical equipment requires special precautions regarding electromagnetic compatibility EMC and must be installed and placed in service according to the EMC information see Appen...

Page 17: ...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 sh...

Page 18: ...trument It is necessary to wait for the instrument to dehumidify before operating the instrument Do not use liquid or aerosol cleaning agents always use a damp cloth Risk of overheating Ambient air te...

Page 19: ...y equipment might endanger the operator If hazardous material has been used or spilled the operator must take care to thoroughly decontaminate the instrument After running the process and prior to dec...

Page 20: ...arrangements contact the authorized local Miltenyi Biotec Service Provider or Miltenyi Biotec Technical Support Chemical and biological hazard Risk of chemical or biological hazards due to contaminat...

Page 21: ...rope contact the authorized local Miltenyi Biotec Service Provider 4 1 1 Intended use The CliniMACS Formulation Unit is an equipment intended to enable the in vitro final formulation and sampling of c...

Page 22: ...s Therefore European GMP guidelines EudraLex Vol 4 have to be followed when using the CliniMACS Formulation Unit for manufacture of cell based medicinal products in Europe For operating the CliniMACS...

Page 23: ...ked and adjusted if necessary Contact authorized local Miltenyi Biotec Service Provider or Miltenyi Biotec Technical Support for installation of the instrument Technical data Model CliniMACS Formulati...

Page 24: ...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 nee...

Page 25: ...d sensor the mounting guide the power cable and the locking clasp see Figure 4 1 and Figure 4 2 The top view of the instrument is shown in Figure 4 1 F13 F12 F11 F10 F9 F8 F7 F6 F5 F4 F3 F2 F1 Mountin...

Page 26: ...The mounting guide and locking clasp see Figure 4 1 are used to mount and secure the CliniMACS Formulation Unit onto the CliniMACS Prodigy The mounting guide helps the insertion and mounting of the Cl...

Page 27: ...n Unit 4 4 3 Installation 1 Attach the two rubber pads provided onto the bag compartment of the CliniMACS Prodigy as shown in Figure 4 3 and insert the bag compartment back into the CliniMACS Prodigy...

Page 28: ...ulation Unit for installation right side view 4 Open the locking clasp see Figure 4 4 by pushing on the front side of the trigger slide it towards the CliniMACS Prodigy and lock it by releasing the tr...

Page 29: ...nual Instrument for more information on the Power CAN connector Carefully connect the plug to the socket to avoid damaging the connector pins The connector fits only in one position Check the orientat...

Page 30: ...28 Connector panel Main power Figure 4 6 Location of the connector panel on the rear side of the CliniMACS Prodigy for connecting the CliniMACS Formulation Unit...

Page 31: ...MACS Prodigy front view 4 4 5 Transport Risk of internal damage Internal damage can occur if the instrument is subjected to excessive vibration or if it is dropped The CliniMACS Formulation Unit shoul...

Page 32: ...ing disinfectants which are compatible with the surface of the instrument Aldehyde up to 3 e g Kohrsolin FF 3 or Ethanol up to 80 Safety and performance of the instrument may be compromised if other t...

Page 33: ...ar The instrument does not require any form of calibration Contact the authorized local Miltenyi Biotec Service Provider for Miltenyi Biotec Instrument Service and support arrangements 4 6 2 Instrumen...

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Page 35: ...nstrument 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 5 2...

Page 36: ...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 opera...

Page 37: ...any case of instrument malfunction or process failure contact the Miltenyi Biotec Technical Support 49 2204 8306 3803 technicalsupport miltenyi com Visit www miltenyibiotec com for local Miltenyi Bio...

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Page 39: ...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...

Page 40: ...iltenyi 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...

Page 41: ...efers to the machinery identified as follows Description Laboratory equipment Model CliniMACS Formulation Unit The machinery complies with all essential requirements of the following directives 2006 4...

Page 42: ...ed as follows Description Laboratory equipment Model CliniMACS Formulation Unit The machinery complies with all essential requirements of the following legislations Supply of Machinery Safety Regulati...

Page 43: ...been attested for the CliniMACS Formulation Unit and the provided components see Table A 1 Guidance and manufacturer s declaration Electromagnetic emissions The equipment is intended for the use in th...

Page 44: ...kV 100 kHz repetition frequency Input output lines Surges IEC 61000 4 5 0 5 kV 1 kV line to line 0 5 kV 1 kV 2 kV line to ground 0 5 kV 1 kV line to line 0 5 kV 1 kV 2 kV line to ground Voltage dips...

Page 45: ...GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation 217 Hz 2 0 3 28 28 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modulation 217 Hz 2 0 3 28 28 5240 55...

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