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Cytomedix Angel Operator's Manual

Concentrated platelet rich plasma (cprp) system
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CONCENTRATED PLATELET RICH
PLASMA (cPRP) SYSTEM
Angel
Concentrated Platelet Rich
®
Plasma (cPRP) System - Operator's Manual
Software Version 1.21
966030107 Rev. E

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Summary of Contents for Cytomedix Angel

  • Page 1 CONCENTRATED PLATELET RICH PLASMA (cPRP) SYSTEM Angel Concentrated Platelet Rich ® Plasma (cPRP) System - Operator’s Manual Software Version 1.21 966030107 Rev. E...

  • Page 2: Table Of Contents

    Product Description ............1-1 Description of the Angel Concentrated Platelet Rich Plasma (cPRP) System .
  • Page 3 External Surfaces ............6-5 Angel cPRP System Operator’s Manual...
  • Page 4 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 .
  • Page 5 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 ®...
  • Page 6 Figure 6-11 Fuse Replacement: Slide Out Holders ........6-10 Angel cPRP System Operator’s Manual...

  • Page 7: Before You Get Started

    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 ®...

  • Page 8: Warnings

    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.
  • Page 9 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.

  • Page 10: Precautions

    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: •...
  • Page 11 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.

  • Page 12: Symbols And Certification

    Manufacturer. and 90% relative humidity. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Install and operate between 10% and 70% relative humidity. SN Serial number. Angel cPRP System Operator’s Manual ®...

  • Page 13: Service Information

    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.

  • Page 14: Chapter 1: Overview

    (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.

  • Page 15: Angel ® Concentrated Platelet Rich Plasma (Cprp) System Components

    5. Valve Assembly Driver 2. Lid Latch Release Handle 6. Stop Button 3. Lid 7. Touch Screen Display 4. Pump Rotor Figure 1-1 Front-view of the Angel Concentrated Platelet Rich Plasma (cPRP) System ® 1. Power Cord 3. Ethernet 2. Power Switch 4.

  • Page 16: Shipping And Storage

    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 CustomerCare@Cytomedix.com.

  • Page 17: Visual Inspection

    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 .

  • Page 18: Setting The Date And Time

    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.
  • Page 19 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 ®...

  • Page 20: Chapter 2: Installing The Disposables

    ® 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...
  • Page 21 5. Whole Blood Compartment 10. 60 ml Specimen Cups 6. RBC Compartment 11. Syringe-activated PRP Valve Figure 2-1 Angel cPRP Processing Set ® PRP Valve Port: A luer lock syringe is attached to the PRP valve port to collect PRP. At the end of a processing cycle, the PRP valve port can also be used to collect PPP.

  • Page 22: Warnings And Precautions

    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 accessory items in the Angel cPRP Processing Set are: ®...
  • Page 23 ® Note: An instructional animation which illustrates the installation of the disposable set (described in the steps below) is available from the Info Screen immediately after powering on the Angel cPRP System. (Refer to “Info Screen” ® on page 3-23) 1.

  • Page 24: Figure 2-3 Mounting The Separation Chamber

    5. 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). Angel cPRP System Operator’s Manual ®...

  • Page 25: Figure 2-4 Centrifuge Stator Arm Aligned With Variable Volume Separation Chamber

    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 blood components. Angel cPRP System Operator’s Manual ®...

  • Page 26: Figure 2-5 Valve Assembly

    4. Syringe-activated PRP Valve Figure 2-5 Valve Assembly 8. Hang the three-compartment reservoir bag on the two support pins located on the side of the Angel Concentrated Platelet Rich Plasma (cPRP) System. ® 9. Remove breather cap from the PRP valve port located on the valve assembly.

  • Page 27: Blood Collection

    Installing the Disposables Blood Collection The Angel Concentrated Platelet Rich Plasma (cPRP) System utilizes a variable ® volume separation chamber that is capable of processing between 40 ml and 180 ml of anticoagulated whole blood or mixture of blood and bone marrow in a single cycle.
  • Page 28 (1 ml of blood weighs approximately 1.053 grams). If a mixture of blood and bone marrow is to be processed using the Angel ® Concentrated Platelet Rich Plasma (cPRP) System, samples of a patient’s bone marrow should be obtained using the techniques and procedures as practiced at each individual hospital or health-care setting.

  • Page 29: Chapter 3: Processing

    Loading the Angel cPRP System ® The proceeding information assumes you have followed the instructions in Chapter 2: Installing the Disposables, beginning with “Turning on the Angel ® cPRP System” on page 2-3. The Load Screen will be displayed on the Angel cPRP System’s touch screen display...

  • Page 30: Figure 3-2 Start Screen

    Up Arrow button and Down Arrow button. If the volume of Screen” on page 3-11. anticoagulated whole blood or mixture of blood and bone marrow available is less than the selected volume to be processed, the Angel Concentrated ®...

  • Page 31: Figure 3-3 Run Screen

    Screen” on page 3-13. accurate values. Once separation is complete, and all components are collected, the End of Cycle Screen is displayed on the Angel cPRP System’s touch screen display (see ® Figure 3-4).

  • Page 32: Figure 3-5 End Of Case Screen

    Data” on page 3-5). The End of Case Screen also allows the entering of case data (refer to “Entering Optional Case Data Fields” on page 3-6). Figure 3-5 End of Case Screen 5. Remove and properly dispose of the Angel cPRP Processing Set in the For a detailed explanation of ®...

  • Page 33: Saving Case Data

    The case number, a sequential number assigned by the machine to every case; the Angel Concentrated Platelet Rich Plasma (cPRP) System serial ® number; the date and time at which the case was started; and the Angel ® cPRP System software version number. •...

  • Page 34: Entering Optional Case Data Fields

    • “ID” field: an identification tag for the case chosen by the operator, may contain letters, numbers, or symbols. “Operator” field: the name of the person operating the Angel cPRP System • ®...

  • Page 35: Modifying Optional Data Field Values

    Keyboard Screen, to delete characters from the field one at a time, or the “Clear” button, located at the bottom of the Keyboard Screen, to delete all characters at once. Angel cPRP System Operator’s Manual ®...

  • Page 36: Selecting Past Cases

    To select past cases for display or saving, perform the following steps: 1. Touch the “Past Cases” button (see Figure 3-8). The Past Cases Screen will appear on the Angel cPRP System’s touch ®...

  • Page 37: Saving A Tally Table To A Usb Storage Device

    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 ® Concentrated Platelet Rich Plasma (cPRP) System.

  • Page 38: Saving A Case Log

    2. If you do not wish to save the current case, then select a past case to save as described in “Selecting Past Cases” on page 3-8. 3. Touch the “Output” button. The Output Screen will appear on the Angel cPRP System’s touch screen ®...

  • Page 39: Touch Screen User Interface

    Concentrated Platelet Rich Plasma (cPRP) System has ® Screen is displayed on the Angel ’s touch screen display. The Start Screen is used completely loaded, the Start Screen is displayed on the Angel’ cPRP System’s to select the whole blood volume to process and to begin each processing cycle touch screen display.
  • Page 40 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 Concentrated Platelet Rich Plasma (cPRP) System ships with a ®...

  • Page 41: Run Screen

    (the green arrow). Modify Volume Button 3-14 Angel Operator’s Manual The volume of whole blood or mixture of blood and bone marrow which has been selected to process is displayed within the Modify Volume button (ml). Touching the Modify Volume button allows the operator to change this volume during the fill stage of processing.
  • Page 42 The icon labeled “PRP” represents the state of the PRP syringe. The number displayed is the approximate volume (ml) of PRP collected by the Angel Whole Blood Separation System . (The number is not the Angel Concentrated Platelet Rich Plasma (cPRP) System. (The ®...

  • Page 43: End Of Cycle Screen

    USB storage device. See “Running the Separation Process” on page 3-1 for instructions on unloading the Angel cPRP Processing Set. ® Angel Operator’s Manual 3-16 Angel cPRP System Operator’s Manual 3-15 ®...

  • Page 44: Figure 3-13 End Of Case Screen

    Angel Whole Blood Separation System , and the case, the serial number of the Angel Concentrated Platelet Rich Plasma (cPRP) ®...

  • Page 45: Menu Screen

    Touching one of the tabs will display the associated menu screen. Language Tab The “Language” tab is used to select the language which the Angel ® Concentrated Platelet Rich Plasma (cPRP) System will use when displaying text (see Figure 3-14).

  • Page 46: Figure 3-15 Tally Tab Of The Menu Screen

    Touching the Close button will close the Menu Screen and return you to the previously displayed screen. 3. Language Buttons Touching one of the Language buttons will cause the Angel Concentrated ® Platelet Rich Plasma (cPRP) System to display all text in that language.
  • Page 47 The "Settings" tab is used to change the volume of audible alarms, set the date and time used internally by the Angel , and to check for new software versions (see Processing Figure 3-16). Figure 3-16 “Settings” tab of the Menu Screen Figure 3-16 "Settings"...

  • Page 48: Info Screen

    Angel’ cPRP System’s touch screen display. The New Software Screen is ® used to check for, download, and install new versions of the Angel Concentrated ® Platelet Rich Plasma (cPRP) System’s software. For details on using the New Software Screen, refer to the section “New Software”...

  • Page 49: Past Cases Screen

    Upon display, the Past Cases Screen lists the six most recent cases prior to the current case. For each listed case, the following information is displayed (from left to right): • the sequential case number automatically assigned by the Angel cPRP System ® •...

  • Page 50: Output Screen

    USB storage device. In addition the “Output” button allows the operator to save a case log to a network server through the Angel cPRP System’s Ethernet port (see Figure 3-19).
  • Page 51 USB storage device or a network server selected by the “Select destination for log file:” field. “Select destination for log file:” Field Used to select a USB storage device connected to the Angel cPRP System’s ®...

  • Page 52: Stop Button

    Press the Stop button mounted on the front of the Angel . This will halt the Angel ’s Press the Stop button mounted on the front of the Angel cPRP System.

  • Page 53: Power Loss

    Processing Power Loss If power is lost to the machine and residual blood/bone marrow is in the variable volume separation chamber, follow these steps to safely remove the Angel ® cPRP Processing Set from the machine: 1. Do not remove the pump loop tubing from the pump rotor until the handle on the valve assembly is pointed toward the whole blood compartment port.

  • Page 54: Chapter 4: Programmability Option

    The first product that is collected after the two-phase cycle is complete is the PPP. The PPP is pumped from the spinning variable volume separation chamber into the PPP compartment. When the sensor of the Angel Concentrated Platelet ®...

  • Page 55: Entering Values And Text

    Programability Option The Angel cPRP System provides additional system flexibility through the use of ® custom protocols in an effort to address the needs of the experienced clinician. Variation in blood parameters may affect the collection of PRP. Custom protocols provide the experienced user with the ability to adjust the centrifugation cycle to meet these possible variations.

  • Page 56: Creating A New Protocol

    3. Touch the Rename button to rename the newly created protocol to a more useful name. Touching the Rename button will display the keyboard screen on the Angel cPRP System’s touch screen display (see Figure 4-2). ®...

  • Page 57: Editing The Parameters Of A Protocol

    Protocol cannot be renamed. 1. From the Protocol pull-down button, select the protocol you wish to rename. 2. Touch the Rename button. Touching the Rename button will display the keyboard screen on the Angel cPRP System’s touch screen display ®...

  • Page 58: Changing The Wakeup Protocol

    Changing the Wakeup Protocol Follow these steps to set a protocol as the wakeup protocol (selected at power-up). The wakeup protocol will be the selected protocol by default whenever the Angel ® Concentrated Platelet Rich Plasma (cPRP) System is turned on.

  • Page 59: Protocol Buttons

    “Enter” to save and return to the “Protocols” tab. Delete Button Touching the delete button deletes the current protocol. Once deleted it will no longer be available from the Protocol pull-down button. Angel cPRP System Operator’s Manual ®...

  • Page 60: Protocol Parameters And Buttons

    Current Protocol The name of the current protocol is displayed at the top right of the “Protocols” tab. Any changes made to the protocol parameters will affect the current protocol after 3 seconds. Angel cPRP System Operator’s Manual ®...

  • Page 61: Protocol Pull-Down Button

    “Make this the default (wakeup) protocol” Button Touching the “Make this the default (wakeup) protocol” button will set the current protocol as the wakeup protocol. Whenever the Angel Concentrated Platelet Rich Plasma (cPRP) System is turned on, the ® wakeup protocol will be used by default.

  • Page 62: Chapter 5: Troubleshooting

    Alarms and Notifications Alarms and Notifications Alarm icons appear as buttons in the alarm area of the Angel ’s touch screen display. Touching an alarm icon will display the Info Screen containing description Alarm icons appear as buttons in the alarm area of the Angel cPRP System’s...
  • Page 63 This alarm indicates a to be unlatched after the hardware failure. If it Start button is pressed, does not resolve itself, the centrifuge is stopped contact the Cytomedix, and the Lid latch alarm Inc. Customer Service is sounded. Response Center. Lid open If the lid is open before Close the lid cover.
  • Page 64 If the alarm is still present, clean the platelet sensor then reinstall the disposable set. (Please see the “Note” on 6-8) If the Angel Power down the Angel Machine temp ® ® Concentrated Platelet cPRP System for a Rich Plasma (cPRP) short time before any System’s temperature...
  • Page 65 Pump underspeed contact the Cytomedix, Alarm icons appear as buttons in the alarm area of the Angel ’s touch screen alarm is sounded. Inc. Customer Service display. Touching an alarm icon will display the Info Screen containing description Response Center.
  • Page 66 Troubleshooting The following table contains description and response information for text notifications which may be encountered while operating the Angel Concentrated ® Platelet Rich Plasma (cPRP) System. Text Description Response Another protocol has this name– The currently displayed protocol If you do not wish any protocol to...
  • Page 67 System was the problem persists, contact ® and on. If the problem persists, powering on. the Cytomedix, Inc. Customer download software. Service Response Center. This version of software is The operator has attempted to Choose a different version of already installed on this machine.

  • Page 68: Troubleshooting The Save Process

    • If an Output Screen becomes unresponsive, cycle the machine power off and then on to correct error condition. If you continue to experience difficulty, contact the Cytomedix, Inc. Customer Service Response Center. Troubleshooting the Software Update Process If you receive the error messages, “Installation failed!” “No software updates found!”...

  • Page 69: Chapter 6: Routine Care

    System’s USB port. ® In addition to updating the system software, it is possible to download and install an earlier system version. Follow these steps to install new software on the Angel Concentrated Platelet ® Rich Plasma (cPRP) System: 1.

  • Page 70: Figure 6-1 Unlock Code Screen

    You may touch the “Cancel” button to return to the New Software Screen without entering an unlock code. 6. Touch the “Continue” button. The selected software version will now be copied to the Angel cPRP ® System’s temporary memory and validated. Three successive progress bars monitor each stage of this process: checking for updates, copying, and finally validating the downloaded files.

  • Page 71: Figure 6-2 Software Validated Screen

    If you decide you do not wish to install a new software version, touch “No” from the Install Screen and you will be returned to the current Angel ® cPRP System software without any changes to the system occurring.

  • Page 72: New Software Screen

    The New Software Screen is displayed by touching the “Check for new software” button from the “Settings” tab of the Menu Screen. It is used to select, download, and install new versions of the Angel Concentrated Platelet Rich Plasma (cPRP) ®...

  • Page 73: Visual Inspection

    ® inspected periodically for any problems such as bent or broken switches, frayed or twisted power cords, and loose or missing hardware. Discontinue use of the Angel ® cPRP System if the device displays one or more of the above conditions until the problem is corrected and it has been verified that the device is operating correctly.

  • Page 74: Non-Routine Care

    Routine Care Routinely verify that all air intake areas of the Angel cPRP System are clear of ® debris and clean as required. Non-Routine Care In the event of a fluid (blood) spill, additional cleaning may be required beyond routine cleaning. For example, fluid spills that accumulate in the centrifuge well...

  • Page 75: Figure 6-6 Removing The Spring Plate And Springs

    Figure 6-7 Cleaning On and Around the Adaptor Base Angel cPRP System Operator’s Manual ®...

  • Page 76: Cleaning The Pump Rotor

    4. Reinstall the pump into the rotor housing by pushing down and turning the rotor clockwise. Angel cPRP System Operator’s Manual ®...

  • Page 77: Preventive Maintenance Requirements

    In the event that a fuse fails, follow these steps to replace it. If the replacement fuse fails, there may be an electrical component failure internal to the machine or a problem with the wall current. Contact the Cytomedix, Inc. Customer Service Response Center. WARNING...

  • Page 78: Figure 6-10 Fuse Replacement: Pry Open Cover

    Using a 9/64 inch hex wrench, tighten the cap screw against the pivot pin. Angel cPRP System Operator’s Manual 6-10...

  • Page 79: Chapter 7: Technical Data

    Technical Data Chapter 7: Technical Data Note: No circuit descriptions or component supply lists are included because the Angel Concentrated Platelet Rich Plasma (cPRP) System includes no user- ® serviceable parts (outside of fuses which are specified on page 6-10).

  • Page 80: Environmental Limitations

    Emission test Compliance Electromagnetic environment - guidance RF emissions CISPR 11 used for domestic Group 1 The Angel Concentrated ® Platelet Rich Plasma (cPRP) System uses RF energy only for its internal function.
  • Page 81 (>95% dip in U should be that of a voltage variations for 0.5 cycle typical commercial or on power supply hospital environment. If the user of the Angel input lines IEC 40% U ® 61000-4-11 (60% dip in U Concentrated Platelet...
  • Page 82 Concentrated Platelet Rich Plasma (cPRP) System is intended for ® use in the electromagnetic environment specified below. The customer or the user of the Angel Concentrated Platelet Rich Plasma (cPRP) System should as- ® sure that it is used in such an environment.

  • Page 83: Classification According To En 60601-1/Iec601-1

    Concentrated Platelet Rich Plasma (cPRP) System should be observed to ® verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Angel Concentrated Platelet Rich Plasma (cPRP) System. ® Over the frequency range 150kHz to 80MHz, field strengths should be less than 3 V/m.

  • Page 84: Chapter 8: Warranty

    This Limited Warranty is in addition to any statutory rights of the Purchaser pursuant to applicable law. Warranty Expiration Cytomedix warrants that all reasonable care has been taken in the manufacture of the Cytomedix™ Angel Concentrated Platelet Rich Plasma (cPRP) System, ®...

  • Page 85: Cases In Which The Warranty Shall Not Be Effective

    Concentrated Platelet Rich Plasma (cPRP) System in the event that such ® component is defective when shipped by Cytomedix up to the time of delivery to the final user unless such defect has been caused by mishandling by the purchaser or the passage of any expiration date indicated on the packaging.

  • Page 86: Limits To The Warranty With Regard To Product Use By The Buyer And/Or User

    Cytomedix makes no guarantee that: (1) a user of the Cytomedix Angel ® Concentrated Platelet Rich Plasma (cPRP) System will use the system correctly,...

  • Page 87: Absolute Prohibition To Amend The Conditions Of This Warranty

    System, not to make claims based on any alleged or proposed changes or alterations made to this Limited Warranty by any representative, agent, dealer, distributor or other intermediary of Cytomedix in violation of the terms hereof. Applicable law and jurisdiction...
  • Page 88 ©2012 Cytomedix, Inc. All rights reserved. Printed in USA. AR-MED a Division of Quintiles, Ltd Runnymede Malthouse Off Hummer Road Egham, Surrey TW20 9BD United Kingdom Cytomedix, Inc. 209 Perry Parkway, Suite 7 Gaithersburg, MD 20877 USA Tel: +1 877-865-9927...

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