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Miltenyi Biotec CliniMACS - User Manual
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CliniMA
CS
®
W
ork
b
ench
User
Manual
For U
.
S. CAUT
I
ON:
Clinical Research Sy
s
tem Limited by Federal (
or United States
) L
aw to In
vestigational
Use or under an F
D
A Approval
V
ersion 1
Original instructions
2
Table of Contents
Main Page
Table of Contents
7
Introduction
11
General Information
11
Service Information
12
Clinimacs Workbench Information
12
Technical Support
12
Glossary
13
Graphical Depiction
13
Glossary of Symbols and Terms
14
Important Safety Information
15
Safety Instructions
18
Usage and Installation
18
Hazards of Electric Shock and Spread of Fire
18
Mechanical Hazards
19
Gas Hazards
20
Chemical and Biological Hazards
20
Servicing and Transport
21
Position of Safety Symbols
22
The Clinimacs Workbench
23
Regulatory Information
23
The Clinimacs Workbench Within the Clinimacs Prodigy Cell & Gene Therapy Manufacturing System
24
Intended Use
24
Compliance
25
Technical Data
26
Components
28
Accessory Power Outlet
30
Main Switch
30
Brake Pedal
31
Hooks
32
Central Supplies
33
Storage Compartment
35
Uninterruptible Power Supply (UPS)
35
Connectors to the Clinimacs Prodigy
36
Unpacking and Installation
36
Scope of Supply
36
Connection of the Central Supplies to the Ceiling Socket
37
Placement of the Clinimacs Prodigy Supplementary Bag
38
Positioning
39
Transport
39
Cleaning and Disinfection
40
Maintenance
40
Servicing
40
Disposal
41
The Clinimacs Workbench Within the Clinimacs Prodigy Cell & Gene Therapy Manufacturing System
43
System Components
43
Additional Materials and Equipment
43
Limitation
44
Warnings and Precautions Regarding the Process
44
Troubleshooting
45
Legal Notes
47
Limited Warranty
47
Trademarks
48
EU/EC Declaration of Conformity
49
Declaration of Conformity
50
Appendix
51
Guidance and Manufacturer's Declaration on Electromagnetic Compatibility
51
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Miltenyi Biotec CliniMACS Specifications
General
Brand
Miltenyi Biotec
Model
CliniMACS
Category
Tool Storage
Language
English
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