Angel® Concentrated Platelet Rich Plasma (cPRP) System - Operator’s Manual Software Version 1.20 DFU-0263-5 Revision 0 05/2020 This page intentionally left blank Table of Contents Before You Get Started Introduction .............................................................................................................................................. vii Indications for Use ................................................................................................................................... vii Contraindications for Use ......................................................................................................................... vii Warnings .................................................................................................................................................. vii Precautions ............................................................................................................................................... x Additional Information .............................................................................................................................. xii Symbols .................................................................................................................................................. xiii Requirements for the disposal of waste electrical and electronic equipment (WEEE) ........................... xiv Service Information ................................................................................................................................. xv Return of Used Product (EMEA) ............................................................................................................. xvi Return of Used Product (Outside EMEA) ............................................................................................... xvi Chapter 1: Overview Product Description ................................................................................................................................ 1-1 Description of the Angel® Concentrated Platelet Rich Plasma (cPRP) System .................................... 1-1 How the Angel® Concentrated Platelet Rich Plasma (cPRP) 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 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 Manual Collection ................................................................................................................................... 3-6 ® Angel cPRP System Operator’s Manual i Enabling the Manual Collection Feature ................................................................................... 3-6 Using the Manual Collection Feature ........................................................................................ 3-7 Saving Case Data .................................................................................................................................. 3-8 Entering Optional Case Data Fields.......................................................................................... 3-9 Modifying Optional Data Field Values ..................................................................................... 3-10 Selecting Past Cases .............................................................................................................. 3-11 Saving a Tally Table to a USB Storage Device ...................................................................... 3-12 Saving a Case Log .................................................................................................................. 3-13 Touch Screen User Interface ............................................................................................................... 3-15 Start Screen ............................................................................................................................ 3-15 Run Screen ............................................................................................................................. 3-17 Manual Collection Run Screen ............................................................................................... 3-19 End of Cycle Screen ............................................................................................................... 3-21 End of Case Screen ................................................................................................................ 3-22 Menu Screen ........................................................................................................................... 3-23 Information Screen .................................................................................................................. 3-27 Past Cases Screen ................................................................................................................. 3-28 Output Screen ......................................................................................................................... 3-29 Stop Button ............................................................................................................................. 3-31 Power Loss ............................................................................................................................. 3-32 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 ........................................................................................ 4-3 Restoring the Parameters of a Protocol .................................................................................... 4-4 Renaming a Protocol................................................................................................................. 4-4 Changing the Wakeup Protocol ................................................................................................ 4-5 Deleting a Protocol .................................................................................................................... 4-5 The Protocols Tab .................................................................................................................................. 4-5 1. Protocol Buttons .................................................................................................................... 4-6 2. Protocol Parameters and Buttons ......................................................................................... 4-7 3. Protocol Pull-Down Button .................................................................................................... 4-8 4. Close Button .......................................................................................................................... 4-8 5-6. Up and Down Arrow Buttons ............................................................................................. 4-8 7. Information Button ................................................................................................................. 4-8 Chapter 5: Troubleshooting Alarms and Notifications .......................................................................................................................