Arthrex Angel User manual

Angel®Concentrated Platelet Rich
Plasma (cPRP) System -
Operator’s Manual
Software Version 1.21
DFU-0262-3 Revision 0
06/2020

This page intentionally left blank

Overview
Angel®cPRP System Operator’s Manual i
Table of Contents
Before You Get Started
Introduction ..............................................................................................................................................vii
Indications for Use ...................................................................................................................................vii
Contraindications for Use.........................................................................................................................vii
Warnings ..................................................................................................................................................vii
Precautions ............................................................................................................................................... x
Symbols .................................................................................................................................................. xiii
Service Information .................................................................................................................................xiv
Return of Used Product ..........................................................................................................................xiv
Chapter 1: Overview
Product Description................................................................................................................................1-1
Description of the Angel®Concentrated Platelet Rich Plasma (cPRP) System ....................................1-1
How the Angel System Works .................................................................................................. 1-1
Angel System Components ...................................................................................................... 1-2
Shipping and Storage ............................................................................................................................ 1-3
Installation ..............................................................................................................................................1-3
Special tools, equipment and environmental requirements ......................................................1-4
Visual Inspection ....................................................................................................................... 1-4
Unpacking/Assembly ................................................................................................................ 1-4
Operational Checks .................................................................................................................. 1-6
Setting the Date and Time ........................................................................................................ 1-6
Chapter 2: Installing the Angel cPRP Processing Set
The Angel Processing Set or Disposable Set........................................................................................ 2-1
Description ................................................................................................................................2-1
Warnings and Precautions........................................................................................................2-3
Setup and Blood/Bone Marrow Aspirate Preparation ............................................................................ 2-3
Turning on the Angel System.................................................................................................... 2-4
Chapter 3: Processing
Before You Begin ................................................................................................................................... 3-1
Loading the Angel System ........................................................................................................3-1
Collecting the Blood or Mixture of Blood and Bone Marrow .....................................................3-1
Running the Separation Process ...........................................................................................................3-2
Saving Case Data .................................................................................................................................. 3-6
Entering Optional Case Data Fields ......................................................................................... 3-7
Modifying Optional Data Field Values....................................................................................... 3-8

Overview
ii Angel®cPRP System Operator’s Manual
Selecting Past Cases................................................................................................................ 3-9
Saving a Tally Table to a USB Storage Device ......................................................................3-10
Saving a Case Log.................................................................................................................. 3-11
Touch Screen User Interface ...............................................................................................................3-12
Start Screen ............................................................................................................................3-12
Run Screen .............................................................................................................................3-14
End of Cycle Screen ...............................................................................................................3-16
End of Case Screen................................................................................................................ 3-17
Menu Screen...........................................................................................................................3-18
Information Screen..................................................................................................................3-22
Past Cases Screen ................................................................................................................. 3-23
Output Screen .........................................................................................................................3-24
Stop Button .............................................................................................................................3-26
Power Loss .............................................................................................................................3-27
Chapter 4: Programmability Option
Creating Custom Protocols .................................................................................................................... 4-1
Entering Values and Text.......................................................................................................... 4-2
Creating a New Protocol ........................................................................................................... 4-3
Editing the Parameters of a Protocol ........................................................................................ 4-4
Restoring the Parameters of a Protocol.................................................................................... 4-4
Renaming a Protocol ................................................................................................................4-5
Changing the Wakeup Protocol ................................................................................................4-5
Deleting a Protocol.................................................................................................................... 4-5
The Protocols Tab.................................................................................................................................. 4-6
1. Protocol Buttons....................................................................................................................4-7
2. Protocol Parameters and Buttons ......................................................................................... 4-7
3. Protocol Pull-Down Button .................................................................................................... 4-8
4. Close Button..........................................................................................................................4-9
5-6. Up and Down Arrow Buttons .............................................................................................4-9
7. Information Button................................................................................................................. 4-9
Chapter 5: Troubleshooting
Alarms and Notifications ........................................................................................................................ 5-1
Troubleshooting the Save Process ........................................................................................................ 5-6
Troubleshooting the Software Update Process ..................................................................................... 5-6
Other Operational & Troubleshooting Tips ............................................................................................5-7
Chapter 6: Routine Care
New Software.........................................................................................................................................6-1
New Software Screen ............................................................................................................................ 6-4
Visual Inspection .................................................................................................................................... 6-5

Overview
Angel®cPRP System Operator’s Manual iii
Routine Care .......................................................................................................................................... 6-5
Non-Routine Care .................................................................................................................................. 6-7
In the Event of a Serious Fluid (Blood) Spill ............................................................................. 6-7
Dissassembling & Cleaning the Centrifuge Parts & Centrifuge Well........................................6-7
Preventive Maintenance Requirements ....................................................................................6-9
Fuse Replacement ..................................................................................................................6-10
Chapter 7: Technical Data
Specifications ......................................................................................................................................... 7-1
Performance Characteristics..................................................................................................... 7-1
Physical Characteristics ............................................................................................................7-1
Environmental Limitations......................................................................................................... 7-1
Chapter 8: Other Commercial Matters
Limitation of Liability.................................................................................................................. 8-1
Technical documentation ..........................................................................................................8-1
Technical safety standards .......................................................................................................8-1
Identification of manufacturer.................................................................................................... 8-3