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Processing

3-12

Angel

cPRP System

Operator’s Manual

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

6. Up Arrow Button

2. Processing Time

7. Down Arrow Button

3. Cycle Enumerator

8. Menu Button

4. Alarm Display Area

9. Information Button

5. Protocol Pull-Down Button

Figure 3-10 Start Screen

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.

Summary of Contents for Angel

Page 1: ...Angel Concentrated Platelet Rich Plasma cPRP System Operator s Manual Software Version 1 21 DFU 0262 3 Revision 0 06 2020 ...

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Page 3: ...tion 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 Chapte...

Page 4: ...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 Chapt...

Page 5: ...rts 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 ...

Page 6: ...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...

Page 7: ... 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 pro...

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Page 9: ...tem 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 appli...

Page 10: ...t 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 suppl...

Page 11: ...fer 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 conn...

Page 12: ...or 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 process...

Page 13: ...se 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 a...

Page 14: ...Overview xii Angel cPRP System Operator s Manual ...

Page 15: ...ization conductor The location of this connection point is at the rear of the machine below the access door Ship and store between these temperatures 20 and 37 7 degrees C 4 and 100 degrees F This symbol indicates the power OFF position on the main power switch Ship and store between 10 and 90 relative humidity This symbol indicates the power ON position on the main power switch Ship and store bet...

Page 16: ...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 nu...

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Page 18: ......

Page 19: ... 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 ...

Page 20: ...stem Components 1 Centrifuge Well 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 System 1 Power Cord 3 USB Port 2 Power Switch Figure 1 2 Rear view of Angel System ...

Page 21: ...tive 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 in...

Page 22: ...ully 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 Telephone 1 800 391 8599 1370 Creekside Blvd support arthrex com Naples FL 34108 USA www arthrex com Unpacking Assembly 1 O...

Page 23: ... 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 qualif...

Page 24: ...me 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 S...

Page 25: ... 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 t...

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Page 27: ...p 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 Cuv...

Page 28: ...Volume Separation Chamber 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 th...

Page 29: ... 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 compone...

Page 30: ...p 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 immedi...

Page 31: ...m 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 Cen...

Page 32: ...y 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 Dis...

Page 33: ...n 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 se...

Page 34: ... 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 ...

Page 35: ...r 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 ...

Page 36: ... 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 Installing the Pump Loop Tubing and Valve Assembly Figure 2 5 Val...

Page 37: ...lve 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 t...

Page 38: ...cPRP System Operator s Manual 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 ...

Page 39: ...ns 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 Processi...

Page 40: ...row Button 2 Protocol Pull Down Button 4 Down Arrow Button Figure 3 2 Start Screen 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 ...

Page 41: ...igure 3 4 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 ...

Page 42: ...e 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 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 ...

Page 43: ...ld 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...

Page 44: ...y 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 ...

Page 45: ...lds 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 b...

Page 46: ...ng 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 dis...

Page 47: ...h Screen Display see Figure 3 8 Figure 3 8 Past Cases Screen 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 w...

Page 48: ...lly to USB storage device Button 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 Tal...

Page 49: ...e 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 scr...

Page 50: ...ect 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 6 Up Arrow Button 2 Processing Time 7 Down Arrow Button 3 Cycle Enumerator 8 Menu Button 4 Alarm Display Area 9 Information Button 5 Protocol Pull Down Button Figure 3 10 Start Screen 1 Start Button The Start Button will begin the blood separation processi...

Page 51: ...ay 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...

Page 52: ...mation Screen on page 3 22 Run Screen The Run Screen tracks the progress of the blood separation process by dynamically displaying in mL the amount of RBC PPP and PRP collected throughout the processing cycle see Figure 3 11 A tally of the total whole blood bone marrow processed and the RBC PPP and PRP collected during a case may be viewed at any time by touching the Menu Button and then touching ...

Page 53: ...efore the originally selected volume of whole blood to be processed has been pumped into the Variable Volume Separation Chamber Variable Volume Separation Chamber The icon labeled Separation Chamber represents the state filling spinning or emptying of the Variable Volume Separation Chamber The number displayed inside the icon is the approximate volume mL of blood currently in the Variable Volume S...

Page 54: ...w Cycle Button will be available Touching the New Cycle Button begins a new cycle and displays the Start Screen see Start Screen on page 3 12 During and after each cycle the operator must pay attention to the PRP volume collected so that the syringe does not overfill after touching the New Cycle Button the text Check PRP syringe will appear beneath the alarm area as a reminder A maximum of 180 mL ...

Page 55: ...arn how to enter values for these fields which will appear in saved tally tables refer to the section Entering Optional Case Data Fields on page 3 7 The tally table in the center of the End of Case Screen displays the total volume of whole blood or the mixture of blood and bone marrow processed in the first column followed by the total volumes of RBC PPP and PRP collected in each cycle The totals ...

Page 56: ...d along with the rest of the case data To learn how to enter the values of a case s optional fields refer to Entering Optional Case Data Fields on page 3 7 Notes Button The Notes Button is used to enter or modify the value of the Notes field which is saved along with the rest of the case data To learn how to enter the values of a case s optional fields refer to Entering Optional Case Data Fields o...

Page 57: ...Close Button Touching the Close Button will close the Menu Screen and return to the previously displayed screen 3 Language Buttons Touching one of the Language Buttons will cause the Angel System to display all text in that language Tally Tab The Tally tab of the Menu Screen displays information about the case that has just completed processing and allows the operator to save that information see ...

Page 58: ...a detailed description read End of Case Screen on page 3 17 For instructions on how to save case data from the Tally tab refer to the Saving Case Data on page 3 6 Protocols Tab The Protocols tab allows for the creation and management of custom protocols See Chapter 4 Programmability Option Settings Tab The Settings tab is used to change the volume of audible alarms set the date and time and to che...

Page 59: ...isplay the arrow buttons Touch the Up and or Down Arrow Buttons to increase and or decrease the volume of key beeps To turn off key beeps set the volume of this parameter to 0 Adjust date time or time zone Button Touching the Adjust date time or time zone Button will display the date and time settings within the Settings tab For instructions on setting these refer to the section Setting the Date a...

Page 60: ...n below see Figure 3 17 1 Close Button 2 Back Button and Forward Button Figure 3 17 Information Screen Close Button Touching the Close Button will close the Information Screen and return to the previously displayed screen Forward Back Buttons The Forward and Back Buttons are only present within Information Screens that contain animations These animations are divided into multiple instructional ste...

Page 61: ...ion is displayed from left to right the sequential case number automatically assigned by the Angel System the date and time the case was started from the moment the Start Button is touched the number of data lines in the case in parenthesis The current case also contains the text current the ID field if any information was entered by the operator For information on entering the ID and other fields...

Page 62: ...than those already displayed Output Screen The Output Screen is displayed by touching the Output Button and is used to save either a case tally table or a case log to a connected USB storage device In addition the Output Button allows the operator to save a case log through the Angel System s USB Port see Figure 3 19 For detailed instructions on how to save case tally tables and logs refer to Savi...

Page 63: ...aving the tally table to a connected USB storage device Output log file to Button Touching the Output log file to Button will start saving case data to the USB storage device Select destination for log file Field This field is used to select a USB storage device connected to the Angel System s USB Port When touched the Select destination for log file field will highlight and the Up and Down Arrow ...

Page 64: ...paration Chamber must be empty in order to remove the disposable set from the machine Figure 3 20 Empty Screen Continue processing Button Touching the Continue processing Button continues processing the current cycle without emptying the Variable Volume Separation Chamber This button is inactive if the Stop Button was pressed during the blood component collection phase Empty the set Button Touchin...

Page 65: ...nually turn the handle on the Valve Assembly to the Whole Blood Compartment port see Figure 3 21 1 Whole Blood Compartment Port Figure 3 21 Correct Valve Assembly Handle Position 2 Remove the Pump Loop Tubing from the Pump Rotor to release fluid pressure on the Variable Volume Separation Chamber to allow the residual blood bone marrow to flow to the Whole Blood Compartment of the three compartment...

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Page 67: ...he Spin 1 and Spin 2 values for RPM and Time can be changed 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 System senses the presence of the PRP layer the Rotating Valve changes position and directs the PRP product to the PRP syringe alo...

Page 68: ...at are created Custom protocols that have changes in RPM and Time should only be created by those knowledgeable in the methodology of blood component separation Figure 4 1 The Protocols tab Entering Values and Text Before attempting to create a new protocol you should familiarize yourself with the controls that are used to make changes When text changes are needed use the keyboard screen illustrat...

Page 69: ...ee Figure 4 2 4 Type in the new name for the protocol 5 When finished touch Enter to save the new name and return to the Protocols tab 6 Make changes to the protocol parameters Note Any changes will automatically be saved 7 It is recommended that most protocol changes concern only Default volume to process and Hematocrit of the PRP product the two topmost fields 8 However if the user needs to chan...

Page 70: ...se the arrow keys to change the value of the parameter d Any changes will automatically be saved 3 Touch the Close Button to return to the previously displayed screen Restoring the Parameters of a Protocol The values of the RPM and Spin Time parameters for any custom protocol may be restored to the recommended Standard Protocol algorithm settings at any time These are the values used for the Stand...

Page 71: ...ed touch Enter to save the new name and return to the Protocols tab 5 Touch the Close Button to return to the previously displayed screen 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 System is turned on 1 Select the protocol you wish to set as the wakeup ...

Page 72: ...tocol the Make this the default wakeup protocol Button unless the selected protocol is already the wakeup protocol as is the case in Figure 4 3 the Close Button the six protocol parameters with the four RPM and Spin Time parameters within a box Up and Down Arrow Buttons A row of buttons for manipulating the protocol name Copy Delete Rename undoing changes redoing changes and getting contextual inf...

Page 73: ...ton will undo your last action e g changing the value of a protocol parameter or renaming a protocol Touching the Redo Button will redo the last action You may undo and redo up to ten different actions 2 Protocol Parameters and Buttons The protocol parameters consist of the six value fields Touching a parameter will highlight both the parameter and the up and down arrow buttons Use the arrow butto...

Page 74: ...efault wakeup protocol Button will set the current protocol as the wakeup protocol Whenever the Angel System is turned on the wakeup protocol will be used by default Modify RPM Time Button Touching the Modify RPM Time Button will allow the four RPM and Spin Time parameters to be modified Once touched it will become disabled and the Restore Button will become enabled Restore Button Touching the Res...

Page 75: ...wn Arrow Buttons Touch the Up and or Down Arrow Buttons to increase and or decrease respectively the value of the currently selected protocol parameter Changes are saved automatically 7 Information Button Touching the Information Button will bring up an Information Screen containing contextual help Touching the Close Button from the Information Screen will return you to displayed screen ...

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Page 77: ... be faster than commanded the Centrifuge over speed alarm is sounded This alarm may indicate a hardware failure If it continues contact Arthrex Inc Customer Service Centrifuge under speed If the centrifuge speed is detected to be slower than commanded the Centrifuge under speed alarm is sounded This alarm may indicate a hardware failure If it continues contact Arthrex Inc Customer Service Insuffic...

Page 78: ...elet Cuvette is securely in place and that the Valve Assembly is properly mounted 2 If the alarm is still active clean the Platelet Sensor then reinstall the disposable set Please see the Note on 6 8 3 Ensure that the Platelet Sensor is at least 1 meter 3 feet from all external light sources Machine temperature Machine temp If the Angel System detects that the temperature is unacceptably high the ...

Page 79: ... Pump Rotor alarm is sounded Remove the Pump Loop Tubing from around the Pump Rotor Press the Pump Rotor down and simultaneously turn it clockwise until it is engaged Place the Pump Loop Tubing around the Pump Rotor Pump under speed If the Angel System detects that the pump speed is slower than commanded the Pump under speed alarm is sounded This alarm may indicate a hardware failure If it continu...

Page 80: ...oftware again If the failure continues use a different download source or contact Arthrex Inc Customer Service Hardware does not support this version of software The operator tried to install a software version that is not supported by the current hardware Select a previous version of software that is compatible with the current hardware Hardware malfunction A hardware malfunction has occurred Cyc...

Page 81: ... the end of a processing case If the power was lost in the middle of a cycle then the set must be emptied A new cycle or case may then be started Redo failed Undo redo history cleared An attempt to redo a change while creating a protocol has failed The undo redo history has been cleared A redo command is not possible at this time Rename failed An attempt to rename a protocol has failed Try renamin...

Page 82: ...e Output Screen The Angel System should now be able to find the appropriate device and the saving process should be successful If an Output Screen becomes unresponsive cycle the machine power off and then on to correct the error condition If you continue to experience difficulty contact Arthrex Inc Customer Service Troubleshooting the Software Update Process If you receive the error messages Insta...

Page 83: ...fety wings striking the stator arm as the centrifuge rotates This will ultimately damage the electrical system 3 Insufficient Fill a Occurs when air is detected by the sensor before the desired amount of blood has been pumped into the variable volume separation chamber This typically happens when the set volume is greater than the volume contained in the whole blood bag b Volume deficiencies can b...

Page 84: ...otor is installed properly see Check the Pump Rotor Installation in Installation Tips section above b Check that the tubing is appropriately installed around the pump head c Ensure that tubing is not crimped along fluid path lines d Inspect whole blood bag to ensure that the draw straw is not occluded by the bag or clotted material e Squeezing the whole blood bag while the pump is rotating can all...

Page 85: ...ice will not process more than 180 ccs of whole blood a The FDA cleared Angel device marketed in the United States can only process a total of 180 cc of blood This total volume of 180cc may be done in a maximum of 3 cycles per disposable b The European version of the Angel device can process a total volume of 540cc maximum of 3 cycles x 180cc each 9 Separated blood components sent to wrong collect...

Page 86: ...a Occurs when end case was not selected after the previous processing procedure i Start new case or manually turn valve manifold on the processing set disposable to match the position of the valve attachment key on the Angel machine 12 The pump rotor spins intermittently and won t draw blood a Occurs when peristaltic pump head is not properly installed see illustrations below for details i Remove ...

Page 87: ...downloaded from a USB storage device connected to the Angel 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 the new software on the Angel System 1 Connect a USB storage device containing a valid software version to the USB Port 2 Access the New Software Screen a Touch the Menu Button from a...

Page 88: ...he manufacturer Figure 6 1 Unlock Code Screen 5 Use the keypad on the Touch Screen Display to enter the unlock code When the correct unlock code has been entered the Continue Button will become enabled 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 be copied to the Angel System s temporary ...

Page 89: ... from in parenthesis and two buttons for final confirmation To cancel the installation of the new software version touch No from the Install Screen It will return to the current Angel System software without any changes to the system software Touch Yes to install the software If the installation is successful a Continue Button is displayed on the Install Screen 8 Touch the Continue Button to compl...

Page 90: ...g the Close Button will close the New Software Screen and display the Menu Screen 2 3 Increment and Decrement Buttons Touching the Increment and or Decrement Buttons scroll through the list of available versions and their sources as displayed in the Select software update source field The selected version may be installed by touching the Download software from this source Button Select software up...

Page 91: ...iscontinue use of the Angel System until the problem is corrected and it has been verified that the device is operating correctly Verify that the USB Port located on the exterior of the Angel System is intact and not damaged Verify that the Stator Arm is not loose on its pivot pin It should only rotate up and down with hand pressure and have no side to side motion If the arm is loose lift it to th...

Page 92: ...n and temperature are followed It is recommended to use a neutral pH enzymatic detergent with given material compatibility 4 Use a soft bristled brush dampened with the detergent solution to remove remaining visible soil for a minimum of one minute 5 Use a clean low linting cloth dampened with the detergent solution to wipe all surfaces of the unit for a minimum of one minute ensuring that the det...

Page 93: ...ernally taking care not to damage the screens Note Not all models are equipped with screens If damage is observed contact Arthrex Inc Customer Care at 1 800 391 8599 or support arthrex com Note Only the external portion of the screen is to be cleaned as required by the customer The unit should never be opened by the customer Non Routine Care In the Event of a Serious Fluid Blood Spill Fluid blood ...

Page 94: ...ws 5 and 6 two turns at a time Set aside the screws for cleaning 1 Spring Plate 2 Adapter Top Figure 6 7 Removing the Centrifuge Adaptor Plate 2 Remove the spring plate taking care not to misplace the springs residing beneath the spring plate Remove the springs and set aside for cleaning Remove the Centrifuge Plate by removing the four cap screws that secure the Centrifuge Plate to the motor spind...

Page 95: ...ase 4 Upon completion of the cleaning procedure a Gather all the parts wrap them in plastic place inside the Centrifuge Well b Confirm sufficient cushioning in included in the well e g above below the parts to ensure they will be held firmly in place during transport c Close the lid d Contact Arthrex Customer Service to obtain a Returned Materials Authorization RMA See Return of Used Product for f...

Page 96: ...revent risk of electrical shock shut OFF power and unplug the system from the electrical outlet before performing cleaning procedures or replacing the fuses 1 Power Switch cover conceals the two fuses Figure 6 10 Fuse Replacement Pry Open Cover 1 Using a flat head screwdriver pry open the cover on the Power Switch 2 Open the cover The two fuse holders are visible Figure 6 11 Fuse Replacement Slide...

Page 97: ...tem Operator s Manual 6 11 3 Replace the fuses with fuses of the identical specifications 5 x 20 mm size 2X F 5A L 250VAC fast blow These can be obtained at any electronic parts retailer 4 Reverse the removal steps to re install ...

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Page 99: ...ocrit requirements 40 mL of anticoagulated whole blood or a mixture of blood and bone marrow volumes require a patient hematocrit of 30 or greater The recommended minimum patient hematocrit for anticoagulated whole blood volumes of 50 mL or greater is 28 Physical Characteristics Characteristic Performance Condition Dimension Height 30 0 cm 11 8 in Nominal Width 50 3 cm 19 8 in Nominal Depth 35 6 c...

Page 100: ... domestic Group 1 The Angel System uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby equipment RF emissions CISPR 11 A The Angel System is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings Harmonic em...

Page 101: ...ce 2007 2014 Electrostatic discharge ESD IEC 61000 4 2 6kV contact 8kV air 8kV contact 15kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Radiated RF IEC 61000 4 3 3 V m 80MHz 2 5GHz1 3V m 80 MHz 2 7 GHz 80 1 kHz AM No additional RF shielding environment requirements necessary Electrical fast transient b...

Page 102: ...p in UT For 250 cycles 50Hz and 300 cycles 60 Hz at 0º Mains power quality should be that of a typical commercial or hospital environment If the user of the Angel System requires continued operation during power mains interruptions it is recommended that the Angel System be powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 30 A m ...

Page 103: ...uld result Immunity Test Test Frequency MHz Band MHz Applicable RF Service Compliance level V m Proximity fields from RF wireless communications equipment IEC 61000 4 3 385 380 390 TETRA 400 27 450 430 470 GMRS 460 FRS 460 28 710 704 787 LTE Band 13 17 9 745 780 810 800 960 GSM 800 900 TETRA 800 IDEN 820 CDMA 850 LTE Band 5 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 190 DECT LTE Band 1 3 4 2...

Page 104: ... 17 P 800MHz to 2 5GHz d 2 33 P 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 69 3 69 7 38 100 11 67 11 67 23 33 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W ...

Page 105: ... whatever purpose nor given out for consultation total or partial to anyone without specific prior authorization being formally given by the manufacturer c The manufacturer reserves the right to make without prior notice amendments or updates to the contents of previously distributed documentation Technical safety standards a The safety standards applicable to the manufacture of the Angel System s...

Page 106: ...duct undergoes safety tests as prescribed by the relevant standards the results of which are available upon request d Any requests for specific measurements of safety parameters different from those above quoted shall be analyzed and assessed by the manufacturer as appropriate ...

Page 107: ...rator s Manual 8 3 Identification of manufacturer Please feel free to contact Arthrex Inc for any further details and or technical assistance Arthrex Inc 1370 Creekside Blvd Naples FL 34108 USA Tel 1 800 391 8599 support arthrex com www arthrex com ...

Page 108: ... Commercial Matters Angel cPRP System Operator s Manual Copyright 2020 Arthrex Inc 1370 Creekside Blvd Naples FL 34108 USA Tel 1 800 391 8599 support arthrex com www arthrex com DFU 0262 3 Revision 0 06 2020 ...

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Arthrex Angel, Operator'S Manual

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