Angel cPRP System Operators Manual sw ver 1.21 Rev 0 June 2020

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Overview

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

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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

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Overview 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

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Overview List of Figures Chapter 1: Overview Figure 1-1 Front-view of the Angel System ........................................................................................... 1-2 Figure 1-2 Rear-view of Angel System .................................................................................................. 1-2 Figure 1-3 Start Screen.......................................................................................................................... 1-3 Figure 1-4 Load Screen ......................................................................................................................... 1-6 Figure 1-5 Date and Time Settings ........................................................................................................ 1-6 Chapter 2: Installing the Disposables Figure 2-1 Angel® Processing Set ......................................................................................................... 2-2 Figure 2-2 Rear-view of Angel System .................................................................................................. 2-4 Figure 2-4 Centrifuge Stator Arm Aligned with Variable Volume Separation Chamber ........................ 2-9 Chapter 3: Processing Figure 3-1 Load Screen ......................................................................................................................... 3-1 Figure 3-2 Start Screen.......................................................................................................................... 3-2 Figure 3-3 Run Screen........................................................................................................................... 3-3 Figure 3-4 End of Cycle Screen............................................................................................................. 3-3 Figure 3-5 End of Case Screen ............................................................................................................. 3-4 Figure 3-6 “Tally” tab of the Menu Screen ............................................................................................. 3-7 Figure 3-7 Keyboard Screen (Text Entry) .............................................................................................. 3-8 Figure 3-8 Past Cases Screen ............................................................................................................... 3-9 Figure 3-9 Output Screen .................................................................................................................... 3-10 Figure 3-10 Start Screen......................................................................................................................3-12 Figure 3-11 Run Screen.......................................................................................................................3-14 Figure 3-12 End of Cycle Screen.........................................................................................................3-16 Figure 3-13 End of Case Screen ......................................................................................................... 3-17 Figure 3-14 “Language” tab of the Menu Screen.................................................................................3-19 Figure 3-15 Tally Tab of the Menu Screen .......................................................................................... 3-20 Figure 3-16 “Settings” tab of the Menu Screen....................................................................................3-21 Figure 3-17 Information Screen ........................................................................................................... 3-22 Figure 3-18 Past Cases Screen...........................................................................................................3-23 Figure 3-19 Output Screen .................................................................................................................. 3-24 Figure 3-20 Empty Screen ................................................................................................................... 3-26 Figure 3-21 Correct Valve Assembly Handle Position ......................................................................... 3-27

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Overview Chapter 4: Programmability Option Figure 4-1 The “Protocols” tab ............................................................................................................... 4-2 Figure 4-2 The Keyboard Screen (Protocol Name) ............................................................................... 4-2 Figure 4-3 “Protocols” tab of the Menu Screen...................................................................................... 4-6 Chapter 6: Routine Care Figure 6-1 Unlock Code Screen............................................................................................................. 6-2 Figure 6-2 Software Validated Screen ................................................................................................... 6-3 Figure 6-3 Install Screen ........................................................................................................................ 6-3 Figure 6-4 New Software Screen........................................................................................................... 6-4 Figure 6-7 Removing the Centrifuge Adaptor Plate ............................................................................... 6-8 Figure 6-8 Removing the Spring Plate and Springs .............................................................................. 6-9 Figure 6-9 Cleaning On and Around the Adaptor Base ......................................................................... 6-9 Figure 6-10 Fuse Replacement: Pry Open Cover ............................................................................... 6-10 Figure 6-11 Fuse Replacement: Slide Out Holders ............................................................................. 6-10 This is not a warranty document. For all warranty information, including disclaimers, exclusions, terms, conditions and related provisions refer to the “Arthrex U.S. Product Warranty” section of the Arthrex, Inc. website, found at www.arthrex.com whose provisions are incorporated herein by reference.

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Overview

Before You Get Started

Introduction

The Angel® Concentrated Platelet Rich Plasma (cPRP) System (Angel System) is designed to separate autologous blood or a mixture of blood and bone marrow. The primary blood components that the Angel System separates and collects are red blood cells (RBC), platelet poor plasma (PPP) and platelet rich plasma (PRP). The Angel System utilizes a Variable Volume Separation Chamber that is capable of processing between 40 mL to 180 mL of anticoagulated whole blood or mixture of blood and bone marrow in a single cycle. A maximum of 180 mL can be processed in up to three (3) cycles for each disposable Angel® Concentrated Platelet Rich Plasma (cPRP) System Processing Set (Angel Processing Set or Disposable Set). This manual is intended for users of the Angel System. The procedures recommended in this Operator’s Manual have been developed and tested to provide safe, reliable and efficient operation of the Angel System. It is important that the operator thoroughly understand the information in this Operator’s Manual before attempting to use the Angel System. Indications for Use

The Arthrex Angel System is indicated to be used intraoperatively at the point of care for the safe and rapid preparation of autologous platelet poor plasma and platelet concentrate (platelet rich plasma) from a small sample of peripheral blood or a small sample of a mixture of peripheral blood and bone marrow. The platelet poor plasma and platelet rich plasma are mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. Disclaimer: Platelet Rich Plasma prepared from a mixture of whole blood and bone marrow may contain higher levels of plasma free hemoglobin than Platelet Rich Plasma prepared from whole blood. Contraindications for Use

Warnings

The Angel System may be contraindicated in cases where there are active systemic infections or systemic heparinization.

1. This device is intended to be used by a trained medical professional. A trained operator should be present at all times to operate and monitor the Angel System during processing. 2. Biohazard waste, such as needles and contaminated surgical equipment, should be safely disposed of in accordance with the institutions policy. Disposal of used equipment and/or used Angel Processing Sets should be performed in accordance with federal, state, and local regulations. These materials should be considered biohazardous. Universal precautions for blood-borne pathogens

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should be practiced (e.g., gloves, Personal Protective Equipment (PPE), etc.) when disposing of these items. 3. The use of operating or maintenance procedures other than those published by the manufacturer, or the use of accessory devices not recommended by the manufacturer may result in poor equipment performance. 4. The manufacturer will not be responsible for patient safety or equipment performance if the Angel System is operated in a manner other than specified in this manual. Medical individuals performing the operations described in this manual must be properly trained and qualified. 5. Any equipment modifications must be performed by qualified persons and be approved by the manufacturer in writing. 6. All electrical installations must comply with all applicable local electrical codes and the manufacturer’s specifications. 7. This equipment, when used with the specified data accessories, meets the following standards identified below. The user does not need to provide additional efforts regarding electromagnetic emissions or immunity: • IEC 60601-1-2 o EN 55011, Class A standards o EN 61000 • Canadian Warning: This equipment is intended for use by healthcare professionals only. The Angel System may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the Angel System or shielding the location. o Use sterile technique when setting up the Angel Processing Set o Thoroughly clean and disinfect the donation site o Use sterile technique whenever handling autologous blood products 8. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Do not use alternate power plugs or adapters that disconnect the safety ground. 9. The operator should never touch the USB port on the Angel System, while at the same time making contact with the patient, as potential for electrical shock may result. 10. Place the Angel System on a flat, stable surface. Never try to move the Angel System while the device is in operation. Failure to comply may result in damage to the Angel System and injury may result. 11. Do not use the Angel System in the presence of flammable agents as an explosion and/or fire may result. 12. Do not contact any moving parts of the centrifuge or pump while the Angel System is in operation. Injury may result. 13. Only Angel Processing Sets are approved for patient use with the Angel System. 14. Do not use the Angel Processing Set if the sterile packaging barrier has been broken. 15. Carefully examine the Angel Processing Set for damage prior to use. Should any evidence of damage to the Processing Set be evident, do not use the Angel Processing Set. 16. Carefully observe the Angel Processing Set for leaks during use. Leakage may Angel® cPRP System Operator’s Manual

Overview

result in loss of sterility of the device or loss of blood product.

17. Use of this product for pediatric patients is at the discretion of a physician. Blood withdrawal from a pediatric patient should be performed in the presence and at the direction of a physician to prevent significant reduction of the circulating blood volume.

18. When collecting and processing autologous blood products, it is recommended that the following precautions be followed to insure that the autologous product is not contaminated: • Use sterile technique when setting up the Angel Processing Set

• Thoroughly clean and disinfect the donation site

• Use sterile technique whenever handling autologous blood products 19. The whole blood or the mixture of blood and bone marrow must be anticoagulated before it can be processed for separation. Inadequate anticoagulation may result in clotting, interfering with the processing of the blood products. Blood containing clots will not pass through the syringe-activated valve located on the Whole Blood Compartment of the Three-Compartment Reservoir Bag.

20. Failure to properly load the Centrifuge Plate prior to processing, may lead to exposure to blood and blood-borne pathogens.

21. If centrifugation is discontinued before the completion of a processing cycle, the Variable Volume Separation Chamber is pressurized and presents the risk for exposure to blood and blood-borne pathogens if the Variable Volume Separation Chamber is not properly removed. Please refer to “Stop Button” on page 3-26 for emptying a Variable Volume Separation Chamber containing blood.

22. If a power loss occurs, and there is blood or a mixture of blood and bone marrow in the Variable Volume Separation Chamber, follow the instructions under “Power Loss” on page 3-27.

23. Failure to properly secure the Luer Lock Syringe to the Valve Assembly may result in a leakage of fluids.

24. Do not connect the patient directly to the Three-Compartment Reservoir Bag. A direct connection to the patient could lead to vascular damage, shock, or an air embolism.

25. Do not place objects in or on the pump during pump rotation. Damage to the machine and Angel Processing Set may occur.

26. If the Angel System fails to operate as intended, do not use the separated blood products.

27. The platelet rich plasma is not intended for transfusion.

28. The Angel System is not intended to be used by the patient. As such a mains power switch is not available to the user. In case of an emergency, power from the unit can be removed by unplugging the unit from the electrical socket.

29. Only devices or cables meeting IEC 60950 and IEC 60601-1 should be connected to the USB Port. Failure to do so may result in operator shock. All cables used in conjunction with the device should be no longer than 1 m (3 ft.) in length. Operators connecting other devices to the USB port must ensure compliance to the system requirements of IEC 60601-1.

30. Operators connecting other devices to the USB Port must ensure compliance to the system requirements of IEC 60601-1. Connection of other devices could result in previously unidentified risk to the patient, operator, or third parties. It is responsibility of the operator to identify, analyze, evaluate, and control any

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Precautions x

previously unidentified risks. 31. The Potential Equalization Conductor (PEC) is a common ground point with the device that is connected directly to the power input ground. The PEC is used for the Angel System Electrical Safety Testing. The PEC is not to be used by the operator to connect additional medical devices to the system during installation, or use of the system. 32. Caution: Federal law restricts this device to sale by or on the order of a physician. 33. Serious incidents should be reported to Arthrex Inc., or an in-country representative, and to the health authority where the incident occurred. 1. Due to the possibility of operator exposure to blood-borne pathogens (such as HIV, hepatitis viruses, bacteria, etc.), Universal Precautions for blood-borne pathogens should be practiced (e.g., gloves, Personal Protective Equipment (PPE), etc.). 2. The Angel Processing Set is intended for single patient use only. a. Each set can be used on the same patient for up to three sequential processing cycles. b. Once used, it should be disposed of properly. c. Do not resterilize any part of this Processing Set. d. The Processing Set should not be re-used for another patient. 3. Carefully read this Operator’s Manual for complete instructions. 4. Use a neutral-pH enzymatic detergent when cleaning the Platelet Sensor. Do not use bleach, abrasive materials or solvents, as they may cause damage to the sensor. 5. Do not place external light sources within 1 meter (3 ft.) of the unit when operating the Angel System. External light sources may interfere with the operation of the Platelet Sensor and may result in reduced processing efficiency. 6. Do not immerse the Pump Rotor in cleaning solution or autoclave, as this may result in damage. 7. Follow the installation instructions included in this manual, prior to first use. 8. To prevent risk of electrical shock, shut OFF the power and unplug the system from the electrical outlet before performing cleaning procedures or replacing the fuses. 9. Immediately report any of the following conditions to the Arthrex, Inc. Customer Service. Don’t use the Angel System until corrective action has been taken: • Damaged or worn Power Cord Assembly, plug or receptacle • Switches that are loose, or do not operate properly • A system that has been subjected to physical damage • A system that has electrically shocked anyone • A system that appears to be overheating 10. It is the responsibility of the health care institution to adequately prepare and identify the product for return shipment. Do not return products that have been exposed to blood-borne infectious diseases. 11. When removing the Angel Processing Set from its packaging, check to ensure that Angel® cPRP System Operator’s Manual

Overview

the three (3) Threaded Luer Caps (see Figure 2-1, item 5) on each Compartment (Whole Blood, RBC and PPP) are securely tightened prior to installation into the Angel System. 12. Failure to properly load the Angel Processing Set, per the enclosed instructions may adversely affect the performance of the system. 13. Luer Lock Syringes should be used with the Angel Processing Set. 14. Pressing the Stop Button during separation may reduce processing efficiency. 15. The physician ordering the collection of PRP shall use discretion when any of the following conditions exist: • sepsis • preoperative hematocrit less than 30% • preoperative platelet count less than 195,000 per µL • hemodynamically unstable • prolonged clotting times • recent use of anti-platelet drugs • inability to maintain stable oncotic pressure 16. Only attach the Power Cord to a power outlet that is properly grounded. 17. Replace the mains fuses only with fuses of the same type and rating. 18. There are no user-serviceable parts inside this device. To avoid the risk of electrical shock, do not remove the cover. Refer all servicing to qualified service personnel. 19. Federal law (USA) restricts this device to sale by or on the order of a physician. 20. If the case data are relevant for patient’s treatment, it will always be necessary to use other Hospital standard measuring instruments. 21. The user of the Angel System is responsible for the monitoring of the system performance, when using custom protocols. 22. The Angel System has been tested and verified to meet applicable Electromagnetic Compatibly (EMC) and Electrical Safety standards, when put into service according to this manual. (Refer to Chapter 7 - “Environmental Limitations”.) 23. The Angel System has the ability to save data using a USB connection. Note: Only devices or cables meeting IEC 60950 and IEC 60601-1 should be connected to the USB Port and/or Ethernet Port(if present). Failure to do so may result in operator shock. All cables used in conjunction with the device should be no longer than 1 m (3 ft.) in length. Operators connecting other devices to the USB ports must ensure compliance to the system requirements of IEC 60601-1. 24. The pins of the USB connector should not be touched, and connection to the port should not be made unless ESD (Electrostatic discharge) precautionary procedures are used.

25. Surgeons are advised to review the product-specific surgical technique prior to performing any surgery. Arthrex provides detailed surgical techniques in print, video, and electronic formats. The Arthrex website also provides detailed surgical technique information and demonstrations. Or, contact your Arthrex representative for an onsite demonstration

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Overview Symbols The following symbols appear on the device labeling. All of the symbols used on the labeling along with the title, description and standard designation number may be found on our website at www.arthrex.com/symbolsglossary.

Catalog number MODEL Model number Follow instructions for use

SN

Serial number

This side up

Date of manufacture

Fragile

This symbol indicates that the device requires an alternating supply current. This symbol identifies the point of connection of a potential equalization conductor. The location of this connection point is at the rear of the machine, below the access door. This symbol indicates the power OFF position on the main power switch.

Keep dry Ship and store between these temperatures: -20 and 37.7 degrees C (-4 and 100 degrees F). Ship and store between 10% and 90% relative humidity.

This symbol indicates the power ON position on the main power switch.

Ship and store between 50 kPa and 106 kPa.

Manufacturer Caution: Federal law (USA) restricts this device to sale by or on the order of a veterinarian.

2x F 5AL 250V

This symbol specifies the type of fuse(s).

Angel® cPRP System Operator’s Manual

Install and operate between 10 and 30 degrees C (50 and 86 degrees F). Install and operate between 10% and 70% relative humidity. Install and operate between 70 kPa and 106 kPa. xiii

Overview Service Information The company accepts responsibility for the safety, reliability and performance of this equipment only if operational procedures, calibrations and repairs are performed by appropriately qualified persons; if all equipment modifications are authorized in writing by the company and performed by appropriately qualified persons; if the electrical installation of the relevant room complies with all applicable local electrical codes; and if the equipment is used in accordance with the published instructions for use. If you require technical assistance, please contact your Customer Service Representative. Arthrex, Inc. 1370 Creekside Blvd Naples, FL 34108 USA Telephone: + 1 800-391-8599 [email protected] www.arthrex.com Return of Used Product If for any reason this product must be returned to Arthrex, Inc., a Returned Materials Authorization (RMA) number is required from Arthrex, Inc. prior to shipping it. If the product has been in contact with blood or body fluids, it must be thoroughly cleaned and disinfected before packing. It should be shipped in either the original carton, or an equivalent carton, to prevent damage during shipment; and it should be properly labeled with the RMA number and an explanation of the biohazardous nature of the contents. Instructions for cleaning and materials, including appropriate shipping containers, proper labeling and an RMA number may be obtained from the Arthrex, Inc. Customer Service (+1 800-391-8599) or [email protected] PRECAUTION It is the responsibility of the health care institution to adequately prepare and identify the product for its return. Do not return products that have been exposed to blood-borne infectious diseases. The shipping address for returned goods is: Arthrex, Inc. 14550 Plantation Road Fort Myers, FL 33912 Telephone: + 1 800-391-8599 [email protected] www.arthrex.com

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Overview Chapter 1: Overview Product Description The Angel® Concentrated Platelet Rich Plasma (cPRP) System (Angel System) consists of a blood processing system and disposable products used for separation of whole blood or a mixture of blood and bone marrow into red cells, platelet poor plasma, and platelet rich plasma. The disposable Angel® Concentrated Platelet Rich Plasma (cPRP) System Processing Set is designed for single-patient use. The Variable Volume Separation Chamber allows the clinician to process from 40 mL to 180 mL of autologous whole blood or a mixture of blood and bone marrow in a single cycle. A maximum of 180 mL can be processed in up to three (3) cycles for each disposable Angel Processing Set. Description of the Angel® Concentrated Platelet Rich Plasma (cPRP) System How the Angel System Works The Angel System processes a determined volume of anticoagulated whole blood or a mixture of blood and bone marrow from a patient and separates the blood/bone marrow into its primary components: red blood cells (RBC), platelet poor plasma (PPP), and platelet rich plasma (PRP). The basic steps are: Blood Collection: The whole blood or a mixture of blood and bone marrow is drawn from a patient and mixed with a citrate anticoagulant. The collected whole blood/bone marrow is mixed in a 7:1 ratio (7 parts whole blood to 1 part citrate anticoagulant (ACD-A)). Please refer to the Instructions for Use for the Angel® Concentrated Platelet Rich Plasma (cPRP) Processing Set for details regarding Blood Collection for further details. Processing: The Angel Processing Set utilizes a Variable Volume Separation Chamber (40 mL to 180 mL) which allows the clinician to determine the amount of preoperative blood/bone marrow volume to be processed. Each Angel Processing Set can be used for up to three processing cycles. Once the anticoagulated whole blood or mixture of blood and bone marrow has been dispensed into the Whole Blood Compartment of the reservoir bag, the clinician selects the desired volume of autologous whole blood/bone marrow to process and presses the “Start” Button on the Touch Screen Display. The Angel System will fill the Variable Volume Separation Chamber with the pre-determined volume of anticoagulated whole blood or a mixture of blood and bone marrow, separate the whole blood/bone marrow through centrifugation, and collect the primary blood components (RBC, PPP, and PRP) in their respective collection compartments. Administration: Reinfusion of blood components is under the control and supervision of the physician in charge. Follow your institution’s blood administration protocol for appropriate handling and labeling of blood components.

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Overview Angel System Components

1. Centrifuge Well 2. Lid Latch Release Handle 3. Lid 4. Pump Rotor

5. Valve Assembly Driver 6. Stop Button 7. Touch Screen Display

Figure 1-1 Front-view of the Angel System

1. Power Cord 2. Power Switch

3. USB Port

Figure 1-2 Rear-view of Angel System

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Overview Touch Screen Display User Interface The color touch screen provides both the controls and the necessary information for operating the Angel System. Below is the start screen.

Figure 1-3 Start Screen

Shipping and Storage 1. Ship and store the carton in an upright position. 2. The contents are fragile. Do not drop, jar or shake the carton. 3. Keep dry. Ship and store between 10% and 90% relative humidity. 4. Store between -20 and 37.7 degrees Celsius (-4 to 100 degrees Fahrenheit). 5. Store between 50 kPa and 106 kPa atmospheric pressure.

Installation

This section contains installation instructions for the Angel System. The Angel System has been designed to be a “plug and play” device and it requires very little preparation to get started. Before proceeding, please note the following: 1. Read the installation procedure in its entirety. 2. Become familiar with any precautionary instructions in this procedure. Note: If problems with the installation occur, contact Arthrex, Inc. Customer Service at +1 800-391-8599 or [email protected]

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Special tools, equipment and environmental requirements There are no special tools required to install and set up this device. PRECAUTION Prior to the first use, follow the installation instructions included in this manual.

Visual Inspection

Upon delivery, ensure that the unit’s shipping carton has not been damaged. If there are signs of damage, a formal complaint must be made at once to the transport agent. Check the unit carefully to ensure that there are no missing parts or visible signs of damage. Any complaints, together with a detailed account of the problems identified must be immediately reported to either the local representative or directly to Arthrex, Inc. at the following address:

Arthrex, Inc. 1370 Creekside Blvd Naples, FL 34108 USA

Telephone: + 1 800-391-8599 [email protected] www.arthrex.com

Unpacking/Assembly 1. Open the shipping carton and remove the Angel System and all ancillary components. Unpacking Tip – Unwrapping the Stator Arm: It is important to note the following when unpacking/ installing the Angel Centrifuge. Failure to heed this recommendation could lead to system malfunction:

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Overview Unpacking Tip: Check the Pump Rotor Installation: a. The Pump Rotor is spring-loaded onto the rotor motor shaft. b. Check to make sure the Pump Rotor is in the proper operational position by gently pulling up on the rotor. c. If it is loose: d. Rotor is installed properly when it cannot be lifted from the rotor housing. 2. Install the device in an operating environment between 10 and 30 degrees C (5086 degrees F), 10% to 70% relative humidity and 70 kPa to 106 kPa pressure. 3. Place the Angel System on a solid, flat work surface. 4. Install the Power Cord Assembly supplied with the equipment into the Angel System. Plug the power into an available power outlet. PRECAUTION There are no user-serviceable parts inside this device. To avoid the risk of electrical shock, do not remove the cover. Refer all servicing to qualified service personnel. NOTE: Due to the possibility of operator exposure to blood borne pathogens (such as HIV, hepatitis viruses, bacteria, etc.), Universal Precautions for blood borne pathogens should be practiced (e.g., gloves, Personal Protective Equipment PPE), etc.).

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Overview Operational Checks Power-up the Angel System by moving the Power Switch located at the back of the machine to the ‘on’ position. Upon power- up, the Angel System will perform an automatic self-test. At this time, the Valve Assembly will also calibrate and reposition itself. Successful completion of that self-test will be evident by visual confirmation of the following screen:

Figure 1-4 Load Screen No other checks or tests are required as part of this installation procedure. Setting the Date and Time The date and time used internally by the Angel System may be set from within the “Settings” tab of the Menu Screen (see Figure 1-5).

Figure 1-5 Date and Time Settings

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Overview To access the date and time settings: 1. Touch the Menu Button from any screen. 2. From the Menu Screen, touch the “Settings” tab. 3. From within the “Settings” tab, touch the “Adjust date, time, or time zone” Button. • The date and time settings will appear within the “Settings” tab. The settings consist of seven fields which may be adjusted: “Year”, “Month”, “Day”, “Hour”, “Min” (for minute), “Sec” (for second), and “Time zone:” To adjust a field: 1. Touch the field to adjust. For example, to change the month, click on the rectangular field labelled “Month”. The field will become highlighted. The Up and Down Arrow Buttons will appear at the right side of the screen. 2. Touch the Up and/or Down Arrow Buttons to increase or decrease the value of the highlighted field. When the “Time zone:” field is highlighted, touching the Up or Down Arrow Buttons will scroll through a list of time zones. Select your region from this list. When a time zone that observes Daylight Saving Time is selected, an option is given to automatically adjust the clock. This feature may be toggled on or off by touching the check-box located below the “Time zone:” field. 3. Once the value of the field is entered, lock in the new value in one of two ways: either touch the highlighted field a second time, or touch another field that needs modifications. When the highlighted field is touched to lock in its value, the field will not be highlighted anymore, and the Up and Down Arrow Buttons will disappear. 4. Once the value of all fields have been set correctly and locked in, touch the Close Button to exit the Menu Screen.

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Installing the Angel cPRP Processing Set Chapter 2: Installing the Angel cPRP Processing Set The Angel Processing Set or Disposable Set Description The Angel Processing Set consists of a pre-connected Variable Volume Separation Chamber, a tubing set with a Platelet Sensor / Valve Assembly, and a ThreeCompartment Reservoir Bag for the collection of blood products (whole blood, red blood cells, and platelet poor plasma). The Angel Processing Set also contains a 20 mL Luer Lock Syringe for the collection of platelet rich plasma (PRP), two 60 mL Specimen Cups for use in a sterile field, a whole blood bag spike adapter, MaleFemale Luer Plugs, and labels for collected blood components. Major Components (see Figure 2-1 below): Variable Volume Separation Chamber: The Angel Processing Set uses a Variable Volume Separation Chamber that can process from 40 mL to 180 mL of anticoagulated autologous whole blood or a mixture of blood and bone marrow in a single cycle. Each Angel Processing Set is capable of processing up to three (3) cycles. The top section of the Variable Volume Separation Chamber (the hard plastic component) is the Separation Chamber Plate. The Separation Chamber Plate is used to seat the Variable Volume Separation Chamber in the centrifuge. Platelet Cuvette / Valve Assembly: The Platelet Cuvette / Valve Assembly contains three major components: (1) the Platelet Cuvette, (2) the Pump Loop Tubing and (3) the Rotating Valve. The Platelet Cuvette is seated into the Platelet Sensor and is used to optimize the collection of the separated blood components. The Pump Loop Tubing is inserted around the pump, which moves volume from the Whole Blood Compartment of the Three-Compartment Reservoir Bag to the Variable Volume Separation Chamber and from the Variable Volume Separation Chamber to the various collection compartments for the separated blood products (PRP, PPP and RBC). The Rotating Valve rotates throughout the processing cycle to direct the whole blood, the mixture of blood and bone marrow, or its separated components through the appropriate pathway. The Platelet Cuvette / Valve Assembly has been designed so that the operator can easily install it while insuring that the Platelet Cuvette is properly seated in the Platelet Sensor and that the Rotating Valve is properly seated on the Valve Assembly Driver.

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1. Platelet Cuvette / Valve Assembly Clip 2. Platelet Cuvette

6. Whole Blood Compartment 7. RBC Compartment

3. Rotating Valve 4. Pump Loop Tubing 5. Threaded Luer Caps (quantity, 3 each)

8. PPP Compartment 9. Three-Compartment Reservoir Bag 10. Variable Volume Separation Chamber

11. 60 ml Specimen Cups (quantity, 2 each) 12. Syringe-activated PRP Valve 13. 20 ml Luer Lock Syringe 14. Male-Female Luer Plug (quantity, 7 each) 15. Whole Blood Spike Adapter

Figure 2-1 Angel® Processing Set

PRP Valve Port: A 20 mL Luer Lock Syringe [13] is attached to the PRP valve port (on the Platelet Cuvette [2]) to collect PRP. At the end of a processing cycle, the PRP valve port can also be used to collect PPP. A Syringe-activated Valve [12] is included as an accessory and can be attached to maintain a closed port when the PRP syringe is removed.

Three-Compartment Reservoir Bag [6, 7 & 8]: The Three-Compartment Reservoir Bag is used to collect anticoagulated whole blood or the mixture of blood and bone marrow and separated blood/bone marrow components. The Whole Blood Compartment [6] is

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Installing the Angel cPRP Processing Set used as a reservoir for collected anticoagulated whole blood from a patient. The clinician may use syringes or whole blood bags to collect the anticoagulated whole blood or the mixture of blood and bone marrow from a patient. The RBC Compartment [7] is used to collect the concentrated red cells at the end of the processing cycle. The PPP Compartment [8] is used to collect platelet poor plasma; the PPP is the first blood component collected after separation has been completed. Syringe-activated valves are used to access the PPP and Whole Blood Compartments of the Three-Compartment Reservoir Bag. Other items included in the Angel Processing Set: 20 mL Luer Lock Syringe [13]: The 20 mL Luer Lock Syringe is used for the collection of platelet rich plasma. However, the Syringe-activated PRP Valve will accommodate most luer fitting syringes. 60 mL Specimen Cups [11] (2 ea.): Two 60 mL Specimen Cups for use in a sterile field. Male/Female Luer Plugs [14]: The male/female luer plugs are used during and at the end of procedure to seal open luer lock connections. Whole Blood Bag Spike Adapter [15]: The Whole Blood Spike Adapter is used to transfer the blood or mixture of blood and bone marrow from a whole blood bag to the Whole Blood Compartment of the Three-Compartment Reservoir Bag. Labels: Appropriate labels for labeling the collected whole blood/bone marrow and separated components. The contents of this set have been sterilized by ethylene oxide gas and have nonpyrogenic fluid pathways. Warnings and Precautions Please see “Warnings” on page vii in the section “Before You Get Started”; see “Precautions” on page x in the same section. Setup and Blood/Bone Marrow Aspirate Preparation IMPORTANT: Due to the possibility of operator exposure to blood borne pathogens (such as HIV, hepatitis viruses, bacteria, etc.), Universal Precautions for blood borne pathogens should be practiced (e.g., gloves, Personal Protective Equipment (PPE), etc.). The Angel Processing Set is intended for single patient use only. • Each set can be used on the same patient for up to three sequential processing cycles. • Once used, it should be disposed of properly. • Do not resterilize any part of this Processing Set. • The Processing Set should not be re-used for another patient.

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Installing the Angel cPRP Processing Set Turning on the Angel System 1. Turn on the Angel System by pressing the Power Switch on the back of the machine. The message, “Self-test in progress. Please stand by” will be displayed on the Angel System’s Touch Screen Display, and then the machine will move the Valve Assembly Driver to the loading position.

1. Power Switch Figure 2-2 Rear-view of Angel System Initial Setup NOTES: Note: Loading the Variable Volume Separation Chamber [9] should always be the first step in the setup process. Loading the Variable Volume Separation Chamber and pressing down on the Separation Chamber Plate will remove excess air volume from the chamber. If excess air is not removed, the Separation Chamber Plate will not load properly. An instructional animation for the installation of the Angel Processing Set (described in the steps below) is available from the Information Screen immediately after powering on the Angel System. (Refer to the “Information Screen” on page 3-22.) An online instructional video entitled “Arthrex Angel® System Processing Procedure Demonstration” is also available at www.arthrex.com Hyperlink: https://www.arthrex.com/resources/pdv/10z8V9nyoEmWbQFEnkcW7Q/arthrexangel-system-processing-procedure-demonstration

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Installing the Angel cPRP Processing Set With the Angel System turned on, do the following: 1. Open the Centrifuge Lid and rotate the Centrifuge to a position so that the interlock mechanism shown in Figure 2-3, item 2 (below) does not interfere with the Stator Arm Brake. NOTE: If the Stator Arm Brake interferes with the interlock mechanism, the Separation Chamber Plate cannot be loaded properly.

1. Separation Chamber Plate • the top section (hard plastic component) of the Variable Volume Separation Chamber 2. Separation Chamber Plate Interlock Mechanism 3. Position Indicators Figure 2-3 Mounting the Variable Volume Separation Chamber 2. Lift the Centrifuge Stator Arm sufficiently to lock the Centrifuge Adapter (with the Stator Arm Brake – see illustration below) within the Centrifuge Well so the Centrifuge Adapter cannot move.

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Installing the Angel cPRP Processing Set Note: While lifting the Centrifuge Stator Arm, inspect to ensure the rubber Stator Arm Cap is present (see illustration below). 3. Remove the Angel Processing Set from the packaging. 4. Lay the Angel Processing Set on the top of the machine. 5. Carefully examine the Angel cPRP Processing Set for damage, prior to use. Do not use if the Processing Set is damaged.

6. Check to ensure that the three (3) Threaded Luer Caps (Figure 2-1, item 5) on each Compartment (Whole Blood, RBC and PPP) are securely tightened prior to proceeding to the next step. 7. Check to ensure that the Disk Bag (at the bottom of the Variable Volume Separation Chamber) is flat. Pressing the Disk Bag flat (by expressing any excess air that might be inside) will better ensure easy installation into the Centrifuge Adapter.

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Installing the Angel cPRP Processing Set 8. Insert the Variable Volume Separation Chamber into the Centrifuge Adapter by aligning the notches in the Separation Chamber Plate with the aligning feature on the Centrifuge Adapter (see illustration immediately below).

9. Once aligned, press the Separation Chamber Plate down near the location of the position indicator and turn it clockwise until the position indicator snaps into place. Note: You should hear an audible click which means the Interlock Mechanisms (Safety Wings) are fully retracted/ engaged and the Separation Chamber Plate is properly installed (see illustrations below for further details).

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10. Place the tube leading from the Variable Volume Separation Chamber through the slot on the rim of the Centrifuge Well. 11. Lower the Centrifuge Stator Arm and align it with the mating feature on the top of the rotating seal of the Variable Volume Separation Chamber (see Figure 2-4).

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1. Stator Arm lowered and aligned Figure 2-4 Centrifuge Stator Arm Aligned with Variable Volume Separation Chamber 12. Close the Centrifuge Lid. After closing the lid, make sure that the tubing remains in the slot on the centrifuge rim and is not occluded or pinched by the lid(see illustration below).

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Installing the Angel cPRP Processing Set 13. Place the Pump Loop Tubing over the Pump Rotor. The pump loop will automatically load when the processing cycle is initiated. Seat the Platelet Cuvette/Valve Assembly by aligning the Platelet Cuvette and the Valve Assembly with the Platelet Sensor body and the Valve Assembly Driver. Press down firmly on the back side of the Platelet Cuvette/Valve Assembly, at position “A” near the pump loop, until the assembly is snapped in place (see Figure 2-5). Note: It is essential that the Platelet Cuvette/Valve Assembly seats fully on the machine to obtain proper sensing of the blood components. Figure 2-5 Valve Assembly A = Position A (see Step 13 above) 1. Platelet Cuvette 2. Valve Assembly 3. Valve Assembly Driver 4. Syringe-activated PRP Valve Installing the Pump Loop Tubing and Valve Assembly

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Installing the Angel cPRP Processing Set 14. Hang the Three-Compartment Reservoir Bag on the two support pins located on the side of the Angel System. 15. Remove the breather cap from the PRP valve port located on the Valve Assembly. If desired, attach the Syringe-activated Valve to the PRP valve port. 16. Attach the 20 mL Luer Lock Syringe (or alternate syringe) to the PRP valve port. Installation Tip: Cycle the Plunger of the 20-mL Luer Lock (PRP) Syringe a. Immediately prior to attaching the PRP syringe to the manifold, cycle the PRP plunger (e.g., prime the plunger), the return it to its original [closed] position), then install the syringe to the manifold. b. The syringe plunger may adhere to the syringe barrel during storage (e.g., plunger sticks or is too tight) which may restrict the proper flow of the PRP into the syringe during the PRP harvest. c. Taking this precautionary measure helps to avoid this from happening. Note: The luer on the PRP valve port will accommodate most luer-lock syringes.

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Installing the Angel cPRP Processing Set Final Set-up

17. After set-up, inspect the circuit to make sure there are no kinks or occlusions. Please refer to the Instructions for Use for the Angel® Concentrated Platelet Rich Plasma (cPRP) Processing Set for further details.

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Processing Chapter 3: Processing Before You Begin Loading the Angel System The proceeding information assumes you have followed the instructions in Chapter 2: Installing the Angel cPRP Processing Set, beginning with “Turning on the Angel System” on page 2-4. After set-up, inspect the Angel Processing Set to make sure there are no kinks or occlusions. The Load Screen will be displayed on the Angel System’s Touch Screen Display (see Figure 3-1).

Figure 3-1 Load Screen 1. Load the Angel Processing Set according to the instructions in Chapter 2, then touch the “Disposable set is loaded” Button.

Collecting the Blood or Mixture of Blood and Bone Marrow

Only clinically trained personnel should collect the blood or mixture of blood and bone marrow according to the Instructions for Use for the Angel® Concentrated Platelet Rich Plasma (cPRP) Processing Set (Blood Collection).

Luer lock syringes should be used with the Angel cPRP Processing Set. The clinician may use syringes or whole blood bags to collect and transfer anticoagulated whole blood or a mixture of blood and bone marrow from a patient. The Angel Concentrated Platelet Rich Plasma (cPRP) System can accommodate anticoagulated whole blood or anticoagulated bone marrow aspirate that has been collected in syringes or blood collection bags.

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Processing The adhesive labels included in the Angel Processing Set packaging can be used to label & uniquely identify the patient’s Processing Set, collected whole blood/bone marrow aspirate and the separated blood/ bone marrow aspirate components, if desired. Note: Before processing more than one cycle of blood or the mixture of blood and bone marrow, agitate the Whole Blood Compartment of the reservoir bag to mix the remaining blood, providing a more uniform collection of blood components. Running the Separation Process Once the Angel Processing Set is loaded and the “Disposable set is loaded” Button has been touched, the Start Screen should be displayed (see Figure 3-2). The system is now ready. 1. From the Start Screen (see Figure 3-2), select the desired protocol using the Protocol Pull-Down Button (unless the displayed protocol will be used).

1. Start Button 2. Protocol Pull-Down Button

3. Up Arrow Button 4. Down Arrow Button

Figure 3-2 Start Screen

For a detailed explanation of the Start Screen, read “Start Screen” on page 3-12. 3-2

2. Select the whole blood or the mixture of blood and bone marrow volume to process using the Up and Down Arrow Buttons. If the volume of the anticoagulated whole blood or mixture of blood and bone marrow available is less than the selected volume to be processed, the Angel System will process the available volume. The minimum processing volume required is 40 mL of whole blood/bone marrow. 3. Touch the Start Button to begin processing. The Angel System will draw the selected volume of anticoagulated whole blood or mixture of blood and bone marrow from the Whole Blood Compartment of the Three-Compartment Reservoir Bag into the Variable Volume Separation Chamber, where it will start the separation process. This process is monitored by the Run Screen (see Figure 3-3). Note: If the volume to be processed needs to be changed after the cycle is started, touch the Modify Volume Button from the Run Screen, illustrated below and described on page 3-15. Angel® cPRP System Operator’s Manual

Processing Note: If the Insufficient fill alarm is triggered, see the response in “Alarms and Notifications” on page 5-1.

For a detailed explanation of the Run Screen, read “Run Screen” on page 3-14.

Figure 3-3 Run Screen During the collection of the blood components, the volumes displayed and the process time displayed may be adjusted by the system software to reflect more accurate values. Once separation is complete, and all components are collected, the End of Cycle Screen is displayed on the Angel System’s Touch Screen Display (see Figure 3-4).

For a detailed explanation of the End of Cycle Screen, read “End of Cycle Screen” on page 3-16.

Figure 3-4 End of Cycle Screen Note: If the cycle needs to be stopped before the separation process has been completed, please refer to “Stop Button” on page 3-26. After each processing cycle, the PRP may be diluted to increase the total volume, by drawing back the PRP syringe plunger. This will draw PPP from the PPP Compartment of the Three-Compartment Reservoir Bag into the PRP syringe.

At the end of the case, the RBC Compartment of the Three-Compartment Reservoir Bag will contain concentrated red blood cells, while the PPP

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Compartment of the Three-Compartment Reservoir Bag will contain platelet poor plasma. Note: Before processing more than one cycle of blood or the mixture of blood and bone marrow, agitate the Whole Blood Compartment of the reservoir bag to mix the remaining blood, providing a more uniform collection of blood components. 4. The Angel System allows a maximum total processing volume of 180 mL. If the maximum volume has not been reached and the available volume is greater than 40 mL, the “New Cycle” Button will be available. Touching the “New Cycle” Button will display the Start Screen (see Step 2). Otherwise, end the case by touching the “End Case” Button. Touching the “End Case” Button will display the End of Case Screen, which displays the total amounts of RBC, PPP, and PRP collected during the case (see Figure 3-5). The End of Case Screen allows the case data to be saved (refer to “Saving Case Data” on page 3-6). The End of Case Screen also allows case data to be entered (refer to “Entering Optional Case Data Fields” on page 3-7).

Figure 3-5 End of Case Screen

For a detailed explanation of the End of Case Screen, read “End of Case Screen” on page 3-17. 3-4

5. Remove and properly dispose of the Angel Processing Set in the following way: a. Open the Centrifuge Lid and rotate the Centrifuge to a position so that the interlock mechanism shown in Figure 2-3, item 2 does not interfere with the Stator Arm Brake. NOTE: If the Stator Arm Brake interferes with the interlock mechanism, the Separation Chamber Plate cannot be unloaded properly. b. Lift the Centrifuge Stator Arm sufficiently to lock the Centrifuge (with the Stator Arm Brake) within the Centrifuge Well so the Centrifuge cannot move. Note: Close all open ports using the Male-Female Luer lock plugs, before removing the Processing Set from the machine. c. Remove the Variable Volume Separation Chamber by twisting it counterclockwise and then lifting it out of the Centrifuge Adapter. d. Remove the Platelet Cuvette / Valve Assembly by grasping the Platelet Cuvette / Valve Assembly release tab and lifting it upwards. To remove the Angel® cPRP System Operator’s Manual

Processing Pump Loop Tubing from the Pump Rotor, turn the Pump Rotor counter clockwise and pull the Pump Loop Tubing from it. e. Remove the Three-Compartment Reservoir Bag from the support pins on the side of the Angel System. 6. Turn off the Angel System using the switch at the rear of the machine. 7. The Angel Processing Set is intended for single patient use only. a. Each set can be used on the same patient for up to three sequential processing cycles. b. Once used, it should be disposed of properly. c. Do not resterilize any part of this Processing Set. d. The Processing Set should not be re-used for another patient.

8. Affix the red Bio-Hazard Label provided in the kit (example above) to the used Angel Processing Set before disposal. 9. Biohazard waste, such as needles and contaminated surgical equipment, should be safely disposed of in accordance with the institutions policy. Disposal of used Angel Processing Sets should be performed in accordance with federal, state, and local regulations. These materials should be considered biohazardous. Universal precautions for blood-borne pathogens should be practiced (e.g., gloves, Personal Protective Equipment (PPE), etc.) when disposing of these items.

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Processing Saving Case Data The Angel System stores a tally table and a detailed log file about every case that has been processed, with an option to save the tally table and the detailed case log file. The tally tables and case logs may be saved to USB storage devices. The case logs may be saved to a USB storage device. Note: Only devices or cables meeting IEC 60950 and IEC 60601-1 should be connected to the USB Port and/or Ethernet Port(if present). Failure to do so may result in operator shock. All cables used in conjunction with the device should be no longer than 1 m (3 ft.) in length. Operators connecting other devices to the USB Port must ensure compliance to the system requirements of IEC 60601-1. Every case includes the following information, which is available as an easily viewable and printable text file: • The case number, a sequential number assigned by the machine to every case; the Angel System serial number; the date and time at which the case was started; and the Angel System software version number. • The “ID” field, as entered by the operator (refer to “Entering Optional Case Data Fields” on page 3-7). • The “Operator” field, as entered by the operator (refer to “Entering Optional Case Data Fields” on page 3-7). • The tally table: the volumes (mL) of the whole blood or the blood and bone marrow mixture processed by the case, as well as volumes of RBC, PPP, and PRP collected during each cycle of the case. When available, the start and end times of the case, as well as the protocol used during processing are included. • The “Notes” field, as entered by the operator (refer to “Entering Optional Case Data Fields” on page 3-7). The optional fields may be left blank. The fields are displayed as blank lines. Once the processing of a case has been completed, there are two places within the Touch Screen user interface where the case data may be saved: • The End of Case Screen, which appears upon completion of each case (see Figure 3-5 above). • The “Tally” tab of the Menu Screen (see Figure 3-6).

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For a detailed explanation of the “Tally” tab, read “Tally Tab” on page 3-19.

Figure 3-6 “Tally” tab of the Menu Screen The “Tally” tab of the Menu Screen may be accessed at any time during a case by touching the Menu Button, and then touching the “Tally” tab. All of the instructions in this section may be performed from either the End of Case Screen or the “Tally” tab of the Menu Screen. PRECAUTION If the case data are relevant for the patient’s treatment, it will be necessary to use other Hospital standard measuring instruments to confirm the case information.

Entering Optional Case Data Fields

In addition to the standard data stored for each case, such as the volumes of collected RBC, PPP, and PRP, the Angel System provides three optional data fields which may be entered by the operator and saved with the standard case data: • “ID” field: an identification tag for the case chosen by the operator, which may contain letters, numbers, or symbols. • “Operator” field: the name of the person operating the Angel System during the case. • “Notes” field: any notes that the operator wishes to store along with a case. Values for the “ID”, “Operator”, and “Notes” fields may only be entered for the current case. The data of past cases cannot be modified. To enter or modify the values of these data fields from either screen, perform the following steps: 1. Touch the button at the bottom of the screen that corresponds to the field to be entered (see Figure 3-6). For example, touch the “ID” Button to enter a value for the “ID” field (see Figure 3-6). The Keyboard Screen will be displayed on the Touch Screen user interface (see Figure 3-7).

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Figure 3-7 Keyboard Screen (Text Entry) 2. Using the Keyboard Screen, type the value into the field. 3. Once the value has been entered, touch the “Enter” Button, located in the lower right corner of the Keyboard Screen. The value of the field will be saved and it will return to the “Tally” tab or the End of Case Screen. Exit the Keyboard Screen without causing any changes to be saved by touching the Close Button located in the upper right corner of the screen. 4. Repeat the previous steps for all three fields, if needed.

Modifying Optional Data Field Values

The following applies to a current case only. After entering values for the optional data fields (as described in “Entering Optional Case Data Fields” on page 3-7), they may be modified before beginning a new case. Once a new case has begun, the values entered for the “ID”, “Operator”, and “Notes” fields cannot be modified. To modify a previously entered value for a field on the current case, perform the following steps: 1. Touch the button at the bottom of the screen that corresponds to the field to be entered (for example, touch the “ID” Button to enter a value for the “ID” field). The Keyboard Screen will be displayed on the Touch Screen Display (see Figure 3-7). The original value of the field is shown at the top of the Keyboard Screen. 2. Modify or make corrections to the field. Use the “Backspace” Button (located at the top of the Keyboard Screen), to delete the characters from the field. Or use the “Clear” Button (located at the bottom of the Keyboard Screen), to delete all of the characters at once. 3. Once the new value has been entered, touch the “Enter” Button, located in the lower left corner of the Keyboard Screen. The value of the field will be saved and it will return to the “Tally” tab or End of Case Screen.

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Processing Exit the Keyboard Screen by touching the Close Button located in the upper right corner of the screen. 4. Repeat the previous steps for all fields that require modification. Selecting Past Cases By default, both the End of Case Screen and the “Tally” tab of the Menu Screen only display and allow the current case to be saved. To select past cases for display or to save, perform the following steps: 1. Touch the “Past Cases” Button (see Figure 3-8). The Past Cases Screen will appear on the Angel System’s Touch Screen Display (see Figure 3-8).

Figure 3-8 Past Cases Screen

For a detailed explanation of the Past Cases Screen, read “Past Cases Screen” on page 3-23.

2. From the Past Cases Screen, locate and touch the case to view or save. Navigate through the list of past cases by touching the Arrow Buttons on the right side of the screen. Once the case is chosen, it will return to the End of Case Screen or the “Tally” tab of the Menu Screen, where the selected case can be saved. Exit the Past Cases Screen without selecting a case, by touching the Close Button located in the upper right corner of the screen. To return to the current case after viewing or saving a past case, return to the Past Cases Screen and select the case at the very top of the list marked “…-(current)”.

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Processing Saving a Tally Table to a USB Storage Device Perform the following steps to save the tally table of a case: 1. Ensure that a USB storage device is connected to the USB Port of the Angel System. 2. If the tally table of the current case will not be saved, then follow the procedure in “Selecting Past Cases” on page 3-9 to select a past case. 3. Touch the “Output” Button. The Output Screen will appear on the Angel System’s Touch Screen Display (see Figure 3-9). The Angel System will scan for a connected storage device, and the text “Searching for connected devices. Please wait…” will appear on the Output Screen. If a USB storage device is detected, the “Output Tally to USB storage device” Button will become enabled.

Figure 3-9 Output Screen

For a detailed explanation of the Output Screen, read

4.

Touch the “Output Tally to USB storage device” Button.

“Output Screen” on page 3-

24.

A progress bar may briefly appear to monitor the progress of the saving process.

Once the entire tally table has been saved, the text “Output saved” will be

displayed beneath the “Output Tally to USB storage device” Button and it will

return to the Output Screen.

The Tally Table can be retrieved from the USB storage device using a PC for later viewing or printing. Each Tally Table is saved in a single text file named with the format “<Serial Number>-<Case Number>.txt”. For example, if the serial number of the Angel System on which the case was run is “GB0000” and the case number of the saved tally table is “00030”, then the name of the file which contains the tally table would be “GB0000-00030.txt”.

If the “Output Tally to USB storage device” Button never becomes enabled, or if the message “Output failed!” appears when trying to save the tally table, consult “Troubleshooting the Save Process” on page 5-6.

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You may exit the Output Screen without causing any changes to take effect by touching the Close Button located at the upper right corner of the screen.

Saving a Case Log

The data for a current or any past case may be saved to an external USB storage device. 1. Ensure that a supported USB storage device is connected to the USB Port. Note: Only devices or cables meeting IEC 60950 and IEC 60601-1 should be connected to the USB Port and/or Ethernet Port (if present). Failure to do so may result in operator shock. All cables used in conjunction with the device should be no longer than 1 m (3 ft.) in length. Operators connecting other devices to the USB Port must ensure compliance to the system requirements of IEC 60601-1. 2. If the current case will not be saved, then select a past case to save as described in “Selecting Past Cases” on page 3-9. 3. Touch the “Output” Button. The Output Screen will appear on the Angel System’s Touch Screen Display (see Figure 3-9). The Angel System will then scan for a connected storage device, and the text “Searching for connected devices. Please wait…” will appear on the Output Screen. If a USB storage device is detected, the “Output log file to:” Button will become enabled. 4. Choose the appropriate destination by performing the following: a. Touch the “Select destination for log file:” field. The field will become highlighted, and the Up and Down Arrow Buttons will appear on the right side of the screen. b. Touch the Up and/or Down Arrow Buttons to scroll through available destinations which the log may be saved to. 5. Once you have chosen your desired destination, touch the “Output log file to:” Button.

A progress bar will appear to monitor the progress of the saving process. Once all data lines have been saved, the text “Output saved” will be displayed beneath the “Output log file to:” Button and it will return to the Output Screen.

If the Stop Button is pressed while the case is being saved, the save process will stop, and an “Output Failed!” message will be displayed.

If the “Output Tally to USB storage device” Button or the “Output log file to:” Button never becomes enabled, or if the “Output failed!” message appears when trying to save, consult the “Troubleshooting the Save Process” on page 5-6.

Exit the Output Screen by touching the Close Button located in the upper right corner of the screen. When you close this screen, it will return to the End of Case Screen or the “Tally” tab.

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Processing Touch Screen User Interface Start Screen The following section offers a detailed description of the user interface, focusing on the screens encountered during normal use. Once the Angel System has completely loaded, the Start Screen is displayed on the Touch Screen Display. The Start Screen is used to select the whole blood or the mixture of blood and bone marrow volume to process and to begin each processing cycle (see Figure 3-10).

1. Start Button 2. Processing Time 3. Cycle Enumerator 4. Alarm Display Area 5. Protocol Pull-Down Button

6. Up Arrow Button 7. Down Arrow Button 8. Menu Button 9. Information Button

Figure 3-10 Start Screen 1. Start Button

The Start Button will begin the blood separation processing cycle. Before starting, set the desired volume of whole blood or the mixture of blood and bone marrow to process using the Up and/or the Down Arrow Buttons.

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Angel® cPRP System Operator’s Manual

Processing 2. Processing Time The “mm:ss” (minutes:seconds) time displayed underneath the analog clock icon indicates the amount of processing time required before the PRP will be collected, once the processing cycle begins. The time is based on the amount of whole blood or the mixture of blood and bone marrow volume selected for processing (using the Up and/or the Down Arrow Buttons). As the Up and/or the Down Arrow Buttons are touched, the processing time will interactively change to reflect the newly selected volumes. On all screens other than the Start Screen, the processing time displays and counts down the remaining time in the current cycle until the PRP is collected. 3. Cycle Enumerator The cycle enumerator displays the current cycle number in any screen. Each case may run up to three cycles. After each cycle, the operator must check the PRP volume collected to ensure that the PRP syringe does not overfill. 4. Alarm Display Alarms are shown as icons in the Alarm Display Area (see Figure 3-10 above). Touching the icon will bring up a context-sensitive information screen that describes the alarm in detail. The various icons which may appear in the Alarm Display Area are detailed in “Alarms and Notifications” on page 5-1. 5. Protocol Pull-Down Button The name of the currently loaded protocol is displayed to the left of the Protocol Pull-Down Button. Touching the Protocol Pull-Down Button will display a list of available protocols; touching the Protocol Pull-Down Button a second time collapses the list. Touching a protocol’s name in the list will select it as the protocol to be used during processing. The protocol may be changed after each cycle of a case. The Angel System is provided with a single Standard Protocol. The Standard Protocol is locked in the computer’s memory and cannot be altered or deleted. Refer to Chapter 4: Programmability Option, for additional information on protocols and creating custom protocols. 6-7. Up and Down Arrow Buttons Touching the Up and/or the Down Arrow Buttons will increase and/or decrease, respectively, the whole blood or the mixture of blood and bone marrow volume to process. The volume that is set to be processed is displayed by the number (in mL) in the center of the Touch Screen Display, and is reflected by the icon labeled “Whole blood volume to process”. A maximum of 180 mL can be processed in up to three (3) cycles for each disposable Angel Processing Set. A cycle can process from 40 to 180 mL of blood or mixture of blood and bone marrow. The default volume is 60 mL.

Angel® cPRP System Operator’s Manual

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