Angel cPRP System Operators Manual sw ver 1.21 Rev E

Table of Contents Before You Get Started Introduction... i Indications for Use... i Contraindications for Use ... i Warnings... ii Precautions... iv Symbols and Certification... vi Service Information... vii Return of Used Product... vii

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® Concentrated Platelet Rich Plasma (cPRP) System Components ... 1-2 Shipping and Storage ... 1-3 Installation... 1-3 Special tools, equipment and environmental requirements... 1-3 Visual Inspection... 1-4 Unpacking/Assembly... 1-4 Operational Checks... 1-4 Setting the Date and Time... 1-5

Chapter 2: Installing the Disposables Angel® Concentrated Platelet Rich Plasma (cPRP) System... 2-1 Description... 2-1 Warnings and Precautions... 2-3 Setup and Blood/Bone Marrow Preparation... 2-3 Blood Collection...2-8

Chapter 3: Processing Before You Begin... 3-1 Loading the Angel® cPRP System... 3-1 Collecting the Blood or Mixture of Blood and Bone Marrow ... 3-1 Running the Separation Process... 3-1 Saving Case Data... 3-5 Entering Optional Case Data Fields ... 3-6 Modifying Optional Data Field Values... 3-7 Selecting Past Cases... 3-8 Angel® cPRP System Operator’s Manual

Saving a Tally Table to a USB Storage Device ... 3-9 Saving a Case Log ... 3-10 Touch Screen User Interface... 3-11 Start Screen... 3-11 Run Screen... 3-13 End of Cycle Screen ... 3-15 End of Case Screen... 3-15 Menu Screen... 3-17 Info Screen ... 3-20 Past Cases Screen ... 3-21 Output Screen... 3-22 Stop Button... 3-24 Power Loss... 3-25

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... 4-4 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. Info Button... 4-8

Chapter 5: Troubleshooting Alarms and Notifications... 5-1 Troubleshooting the Save Process... 5-7 Troubleshooting the Software Update Process... 5-7

Chapter 6: Routine Care Precaution Statement ... 6-1 New Software ... 6-1 New Software Screen ... 6-4 Visual Inspection... 6-5 Routine Care... 6-5 External Surfaces ... 6-5

Angel® cPRP System Operator’s Manual

Non-Routine Care... 6-6 Cleaning the Centrifuge Well... 6-6 Cleaning the Pump Rotor ... 6-8 Preventive Maintenance Requirements... 6-9 Data Integrity Accessories... 6-9 List of Operator Replaceable Parts... 6-9 Fuse Replacement ... 6-9

Chapter 7: Technical Data Specifications ... 7-1 Performance Characteristics... 7-1 Physical Characteristics... 7-1 Environmental Limitations... 7-2 Classification according to EN 60601-1/IEC601-1... 7-6

Chapter 8: Warranty Limited warranty and contractual conditions for Cytomedix, Inc. medical devices... 8-1 Warranty Expiration... 8-1 Contents and necessary requirements of the warranty... 8-1 Cases in which the warranty shall not be effective ... 8-2 Warranty for replaced parts... 8-2 Availability of spare parts... 8-2 Technical documentation... 8-2 Maintenance contracts... 8-2 Limits to the warranty with regard to product use by the buyer and/or user ... 8-3 Technical safety standards applicable for the purpose of the warranty... 8-3 Absolute prohibition to amend the conditions of this warranty... 8-4 Applicable law and jurisdiction... 8-4 Identification of manufacturer ... 8-4

Angel® cPRP System Operator’s Manual

List of Figures Chapter 1: Overview Figure 1-1 Front-view of the Angel® Concentrated Platelet Rich Plasma (cPRP) System ... 1-2 Figure 1-2 Rear-view of the Angel® Concentrated Platelet Rich Plasma (cPRP) System... 1-2 Figure 1-3 Start Screen... 1-3 Figure 1-4 Load Screen... 1-4 Figure 1-5 Date and Time Settings... 1-5

Chapter 2: Installing the Disposables Figure 2-1 Angel® cPRP Processing Set... 2-2 Figure 2-2 Rear-view of the Angel® Concentrated Platelet Rich Plasma (cPRP) System... 2-4 Figure 2-3 Mounting the Separation Chamber ... 2-5 Figure 2-4 Centrifuge Stator Arm Aligned with Variable Volume Separation Chamber... 2-6 Figure 2-5 Valve Assembly ... 2-7

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... 3-5 Figure 3-7 Keyboard Screen (Text Entry) ... 3-6 Figure 3-8 Past Cases Screen ... 3-8 Figure 3-9 Output Screen ... 3-9 Figure 3-10 Start Screen... 3-13 Figure 3-11 Run Screen ... 3-15 Figure 3-12 End of Cycle Screen ... 3-18 Figure 3-13 End of Case Screen... 3-19 Figure 3-14 “Language” tab of the Menu Screen ... 3-20 Figure 3-15 “Tally” tab of the Menu Screen... 3-21 Figure 3-16 “Settings” tab of the Menu Screen... 3-22 Figure 3-17 Info Screen... 3-23 Figure 3-18 Past Cases Screen ... 3-24 Figure 3-19 Output Screen ... 3-25 Figure 3-20 Empty Screen... 3-27 Figure 3-21 Correct Valve Assembly Handle Position... 3-28

Angel® cPRP System Operator’s Manual

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 6-5 Removing the Centrifuge Adaptor Plate... 6-6 Figure 6-6 Removing the Spring Plate and Springs ... 6-7 Figure 6-7 Cleaning On and Around the Adaptor Base... 6-7 Figure 6-8 Removing the Pump Rotor... 6-8 Figure 6-9 Reinstalling the Pump into the Rotor Housing... 6-9 Figure 6-10 Fuse Replacement: Pry Open Cover... 6-10 Figure 6-11 Fuse Replacement: Slide Out Holders... 6-10

Angel® cPRP System Operator’s Manual

Before You Get Started

Before You Get Started Introduction The Angel® Concentrated Platelet Rich Plasma (cPRP) System (Angel) is designed to separate autologous blood or a mixture of blood and bone marrow. The primary blood components that the Angel® Concentrated Platelet Rich Plasma (cPRP) System separates and collects are red blood cells (RBC), platelet poor plasma (PPP) and platelet rich plasma (PRP). The Angel® Concentrated Platelet Rich Plasma (cPRP) System utilizes a variable volume separation chamber that is capable of processing between 40 ml - 180 ml of anticoagulated whole blood or mixture of blood and bone marrow in a single cycle. A total of 180 ml can be processed over three (3) cycles per disposable. This manual is intended for users of the Angel® Concentrated Platelet Rich Plasma (cPRP) System. The procedures recommended in this Operator’s Manual have been developed and tested to provide safe, reliable and efficient operation of the Angel® Concentrated Platelet Rich Plasma (cPRP) System. It is important that the operator thoroughly understand the information in this Operator’s Manual before attempting to use the Angel® Concentrated Platelet Rich Plasma (cPRP) System.

Indications for Use The Angel® Concentrated Platelet Rich Plasma (cPRP) System is intended to be used in the clinical labaratory or interoperatively at the point-of-care for the safe and rapid preparation of platelet poor plasma and concentrate (platelet rich plasma) from a small sample of whole blood or a small mixture of blood and bone marrow. The platelet rich plasma from the Angel® Concentrated Platelet Rich Plasma (cPRP) System can also be mixed with autograft and/or allograft bone prior to the application to an orthopedic site. 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 The Angel® Concentrated Platelet Rich Plasma (cPRP) System may be contraindicated in cases where there is active systemic infections or systemic heparinization.

Angel® cPRP System Operator’s Manual

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Before You Get Started

Warnings 1.

The use of operating or maintenance procedures other than those published by Cytomedix, Inc., or the use of accessory devices not recommended by Cytomedix, Inc. may result in poor equipment performance. Cytomedix, Inc. will not be responsible for patient safety or equipment performance if the procedures to operate and maintain the Angel® Concentrated Platelet Rich Plasma (cPRP) System are other than those specified by Cytomedix, Inc. Persons performing the procedures must be properly trained and qualified. Any equipment modifications must be performed by qualified persons and be approved by Cytomedix, Inc. in writing. All electrical installations must comply with all applicable local electrical codes and Cytomedix, Inc. specifications. This equipment meets the following standards in the United States and the user does not need to provide additional efforts regarding electromagnetic emissions or immunity: • • • •

ii

EN 55011, Class A standards (for electromagnetic emissions) EN 61000 (for electromagnetic emissions) IEC 60601-1-2 (2007) (for electromagnetic immunity) Canadian Warning: This equipment is intended for use by healthcare professionals only. The Angel® Concentrated Platelet Rich Plasma (cPRP) System may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as reorienting or relocating the Angel® Concentrated Platelet Rich Plasma (cPRP) System or shielding the location.

2.

The operator should never touch the data port on the Angel® cPRP System, while at the same time making contact with the patient, as potential for electrical shock may result.

3.

Place the Angel® Concentrated Platelet Rich Plasma (cPRP) System on a flat, stable surface. Never try to move the Angel® Concentrated Platelet Rich Plasma (cPRP) System while the device is in operation. Failure to comply may result in damage to the Angel® Concentrated Platelet Rich Plasma (cPRP) System and injury may result.

4.

Do not use the Angel® Concentrated Platelet Rich Plasma (cPRP) System in the presence of flammable agents because an explosion and/or fire may result.

5.

A trained operator should be present at all times to operate and monitor the Angel® Concentrated Platelet Rich Plasma (cPRP) System during processing.

6.

Do not contact any moving parts of the centrifuge or pump while the Angel® Concentrated Platelet Rich Plasma (cPRP) System is in operation. Injury may result.

7.

To prevent risk of electrical shock, do not use alternate power plugs or adapters that disconnect the safety ground.

8.

Only Angel® cPRP Processing Sets are approved for patient use with the Angel® Concentrated Platelet Rich Plasma (cPRP) System.

9.

Do not use the Angel® cPRP Processing Set if the sterile packaging barrier has been broken. Angel® cPRP System Operator’s Manual

Before You Get Started

10. Carefully examine the Angel® cPRP Processing Set for damage prior to use. Should any evidence of damage to the Processing Set be evident, do not use the Processing Set. 11. Carefully observe the Angel® cPRP Processing Set for leaks during use. Leakage may result in loss of sterility of the device or loss of blood product. 12. 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. 13. 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® cPRP Processing Set Thoroughly clean and disinfect the donation site Use sterile technique whenever handling autologous blood products

14. 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. 15. Failure to properly load the centrifuge plate prior to processing may lead to exposure to blood and blood-borne pathogens. 16. 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 3-27 for emptying a variable volume separation chamber containing blood. 17. 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 3-28. 18. Failure to properly secure the luer lock syringe to the valve assembly may result in a leakage of fluids. 19. Do not directly connect the patient to the three-compartment reservoir bag. Direct connection to the patient could lead to vascular damage, shock, or air embolism. 20. Disposal of used equipment and/or used Angel® cPRP Processing Sets should be in accordance with federal, state, and local regulations. These materials should be considered biohazardous. Universal precautions for blood-borne pathogens should be practiced when disposing of these items. 21. Do not place objects in pump during pump rotation. Damage to machine and disposable may result. 22. Do not use the separated blood products if the Angel® Concentrated Platelet Rich Plasma (cPRP) System fails to operate as intended. 23. The platelet rich plasma is not intended for transfusion.

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Before You Get Started

Warnings (Cont.) 24. The Angel® Concentrated Platelet Rich Plasma (cPRP) System is not intended to be used directly 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. 25. Only devices or cables meeting IEC 60950 should be connected to the USB and/ or Ethernet port. Failure to do so may result in operator shock. All cables used in conjunction with the device should be no longer than 1m (3ft) in length.

Precautions 1. Carefully read this Operator’s Manual for complete instructions. 2. This product is intended for use by trained medical personnel only. 3. When cleaning the platelet sensor, do not use bleach, abrasive materials or solvents as they may cause damage to the sensor. Use a mild detergent. 4. Do not place external light sources within 1 meter (3 feet) of the unit when operating the Angel® Concentrated Platelet Rich Plasma (cPRP) System. External light sources may interfere with the operation of the platelet sensor and may result in reduced processing efficiency. 5. Do not immerse the pump rotor in cleaning solution. Do not autoclave. Component damage may result. 6. Prior to first use follow the installation instructions included in this manual. 7. Any device connected to the data port must comply with the applicable IEC standard for that device. 8. To prevent risk of electrical shock, shut OFF power and unplug the system from the electrical outlet before performing cleaning procedures or replacing the fuses. 9. Report immediately to the Cytomedix, Inc. Customer Service Response Center any of the following conditions. Do not use the Angel® Concentrated Platelet Rich Plasma (cPRP) System until corrective action has been taken: • • • • •

Damaged or worn power cord, plug or receptacle Switches that are loose or do not operate with a positive action A system that has been subject to significant physical damage A system that has given anyone an electrical shock while in use 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. Due to the possibility of operator exposure to blood-borne pathogens (such as HIV, hepatitis viruses, bacteria, etc.), Universal Precautions for bloodborne pathogens should be practiced.

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Angel® cPRP System Operator’s Manual

Before You Get Started

12. The Angel® cPRP Processing Set is intended for single patient use. Each set can be used on the same patient for up to three processing cycles. Do not resterilize any part of this Processing Set. 13. Failure to properly load the Angel® cPRP Processing Set per the enclosed instructions may affect the performance of the system. 14. Luer lock syringes should be used with the Angel® cPRP Processing Set. 15. Pressing the Stop button during separation may reduce processing efficiency. 16. 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 ul hemodynamically unstable prolonged clotting times recent use of anti-platelet drugs inability to maintain stable oncotic pressure

17. Attach the power cord only to a power receptacle which is properly grounded. 18. Replace the mains fuses only with fuses of the same type and rating. 19. 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. 20. Take care not to misplace the screws and springs when disassembling the centrifuge adaptor plate. If springs or screws are misplaced, you may order replacements by contacting Cytomedix, Inc. 21. Federal law (USA) restricts this device to sale by or on the order of a physician. 22. The user of the Angel® Concentrated Platelet Rich Plasma (cPRP) System is responsible for the monitoring of the system performance when using custom protocols. 23. The Angel® Concentrated Platelet Rich Plasma (cPRP) System has been tested and verified to meet applicable Electromagnetic Compatibly (EMC) and Electrical Safety standards when used in conjunction with the specified Data Integrity Accessories. (Refer to Section 6.) 24. The Angel® Concentrated Platelet Rich Plasma (cPRP) System has the ability to save data using both the USB and Ethernet Network connections. When using either of these connections, it is recommended that the applicable Data Integrity Accessory be used. (Refer to Section 6.)

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Before You Get Started

Symbols and Certifications If applicable, the following symbols may appear on the device labeling. This symbol specifies the type of fuse(s).

Catalog number.

MODEL

Model number.

2X F 5A 250V

To reduce the risk of electrical shock, do not remove cover. There are no user-serviceable parts inside. Refer servicing to qualified service personnel.

Attention. Consult accompanying documents. (IEC 60601-1, 2nd Edition)

Caution. (IEC 60601-1, 3rd. Edition) This side up Follow instructions for use.

Fragile

Date of manufacture.

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.

Keep dry

37.7°C

-20°C

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

30°C 10°C

Ship and store between these temperatures: -20 and 37.7 degrees C (-4 and 100 degrees F).

Install and operate between 10 and 30 degrees C (50 and 86 degrees F).

90%

Ship and store between 10% and 90% relative humidity.

Manufacturer. 10%

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

SN vi

70%

Install and operate between 10% and 70% relative humidity.

SN Serial number. 10%

Angel® cPRP System Operator’s Manual

Before You Get Started

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. Should you require technical assistance, contact your Customer Service Representative. Cytomedix, Inc. Customer Service Response Center 209 Perry Parkway, Suite 7 Gaithersburg, MD 20877 USA Telephone: +1 877-865-9927 Telephone: +1 301-917-6860 Fax: +1 240-499-2690 [email protected] www.Cytomedix.com

Return of Used Product If for any reason this product must be returned to Cytomedix, Inc., a returned goods authorization (RGA) number is required from Cytomedix, Inc. prior to shipping. 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 an RGA number and an indication of the biohazardous nature of the contents of the shipment. Instructions for cleaning and materials, including appropriate shipping containers, proper labeling and an RGA number may be obtained from the Cytomedix, Inc. Customer Service Response Center (877-865-9927) or [email protected]. PRECAUTION 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. The shipping address for returned goods is: Cytomedix, Inc. Customer Service Response Center 209 Perry Parkway, Suite 7 Gaithersburg, MD 20877 USA Telephone: +1 877-865-9927 Telephone: +1 301-917-6860 Fax: +1 240-499-2690 [email protected] www.Cytomedix.com Angel® cPRP System Operator’s Manual

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Overview

Chapter 1: Overview Product Description The Angel® Concentrated Platelet Rich Plasma (cPRP) System (Angel® cPRP System) consists of a blood processing device and disposable products used for separation of whole blood or mixture of blood and bone marrow into red cells, platelet poor plasma, and platelet rich plasma. The processing disposable, the 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 mixture of blood and bone marrow in a single cycle. A total of 180 ml can be processed over three (3) cycles per disposable.

Description of the Angel® Concentrated Platelet Rich Plasma (cPRP) System How the Angel® Concentrated Platelet Rich Plasma (cPRP) System Works The Angel® Concentrated Platelet Rich Plasma (cPRP) System processes a determined volume of anticoagulated whole blood or 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 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)). Processing: The Angel® (cPRP) Processing Set utilizes a variable volume separation chamber (40 ml – 180 ml) which allows the clinician to determine the amount of preoperative blood/bone marrow volume to be processed. The Angel® cPRP Processing Set allows for up to three processing cycles per disposable. Once the anticoagulated whole blood or mixture of blood and bone marrow has been dispensed into the whole blood compartment of the three-compartment reservoir bag, the clinician selects the desired volume of autologous whole blood/bone marrow they elect to process and presses the “Start” button on the touch screen display. The Angel® Concentrated Platelet Rich Plasma (cPRP) System will fill the variable volume disposable with the pre-determined volume of anticoagulated whole blood or 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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Angel® cPRP System Operator’s Manual

Overview

Angel® Concentrated Platelet Rich Plasma (cPRP) System Components

1. 2. 3. 4.

Centrifuge Well Lid Latch Release Handle Lid Pump Rotor

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

Figure 1-1 Front-view of the Angel® Concentrated Platelet Rich Plasma (cPRP) System

1. Power Cord 2. Power Switch

3. Ethernet 4. USB Port

Figure 1-2 Rear-view of Angel® Concentrated Platelet Rich Plasma (cPRP) System

Angel® cPRP System Operator’s Manual

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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® Concentrated Platelet Rich Plasma (cPRP) System. Below is a typical screen.

Figure 1-3 Start Screen

Shipping and Storage 1. Ship and store carton in an upright position. 2. The contents are fragile. Do not drop or jar 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).

Installation This section contains installation instructions for the Angel® Concentrated Platelet Rich Plasma (cPRP) System. The Angel® Concentrated Platelet Rich Plasma (cPRP) System has been designed to be essentially a “plug and play” device, and, as such, requires very little preparation to get started. However, before proceeding, please note the following: 1. Read the installation procedure in its entirety. 2. Become familiar with any precautionary indications noted in this procedure. Note: If at any time you encounter problems with the installation of the Angel® Concentrated Platelet Rich Plasma (cPRP) System, contact Cytomedix, Inc. Customer Service Response Center at 877-865-9927 or [email protected].

Special tools, equipment and environmental requirements There are no special tools required to install and set up this device. PRECAUTION

Prior to first use follow the installation instructions included in this manual. 1-3

Angel® cPRP System Operator’s Manual

Overview

Visual Inspection 1. Inspect the exterior of the shipping container and verify that no visual damage is present. A. If damage is present, notify Cytomedix, Inc. Customer Service Response Center at 877-865-9927 to report the damage. B. If no damage is present, proceed with the installation.

Unpacking/Assembly 1. Open the shipping carton and remove the Angel® Concentrated Platelet Rich Plasma (cPRP) System and all ancillary components from the shipping carton. Install the device in an operating environment between 10 and 30 degrees C (50-86 degrees F) and 10%-75% relative humidity. 2. Place the Angel® Concentrated Platelet Rich Plasma (cPRP) System on a solid, flat work surface. 3. Install the power cord supplied with the equipment into the Angel® Concentrated Platelet Rich Plasma (cPRP) 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.

Operational Checks Power-up the Angel® Concentrated Platelet Rich Plasma (cPRP) System by moving the power switch located at the back of the machine to the on position. On powerup, the Angel® Concentrated Platelet Rich Plasma (cPRP) 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 start-up screen:

Figure 1-4 Load Screen No other checks or tests are required as part of this installation procedure. Angel® cPRP System Operator’s Manual

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Overview

Setting the Date and Time The date and time used internally by the Angel® Concentrated Platelet Rich Plasma (cPRP) System may be set from within the “Settings” tab of the Menu Screen (see Figure 1-5).

Figure 1-5 Date and Time Settings To access the date and time settings, do the following: 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 you wish to adjust. For example, if you wish to change the month, click on the rectangular field labelled “Month”. The field will become highlighted, and the Up Arrow button and Down Arrow button will appear at the right side of the screen. 2. Touch the Up Arrow button and Down Arrow button to increase or decrease, respectively, the value of the highlighted field. When the “Time zone:” field is the highlighted field, touching the Up Arrow button and Down Arrow button will scroll through a list of time zones. Select your region from this list. When a time zone which observes Daylight Saving Time is selected, the option is given to automatically adjust the clock. This featured may be toggled on or off by touching the check-box located below the “Time zone:” field.

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Angel® cPRP System Operator’s Manual

Overview

Setting the Date and Time (Cont.) 3. Once you are satisfied with the value of the field, you may lock in its new value in two ways: either touch the highlighted field a second time, or touch another field which needs modifying. When the highlighted field is touched to lock in its value, it will become nothighlighted, and the Up Arrow button and Down Arrow button 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.

Angel® cPRP System Operator’s Manual

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Installing the Disposables

Chapter 2: Installing the Disposables Angel® cPRP Processing Set Description The Angel® cPRP Processing Set consists of a pre-connected variable volume separation chamber, a tubing set with a platelet sensor/valve assembly, and a three-compartment reservoir bag for the collection of blood products (whole blood, red blood cells, and platelet poor plasma). The Angel® cPRP 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, male-female luer plugs, and labels for collected blood components. Major Components (see Figure 2-1) Variable Volume Separation Chamber: The Angel® cPRP Processing Set utilizes a variable volume separation chamber that can process from 40 ml – 180 ml of anticoagulated autologous whole blood or mixture of blood and bone marrow in a single cycle. The Angel® cPRP Processing Set is capable of processing up to three (3) cycles per disposable. The top half 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 in 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 course of 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 the platelet cuvette/valve assembly 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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Angel® cPRP System Operator’s Manual