Stryker 0703-001-000 Instructions For Use Manual Download Page 63

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Signature History Report

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Related Information

CR Number

CR0220689

CR Class

DMR-All Pre-Commercial Release

Originating Entity

INST: Kalamazoo

Origin

New Product Development

Initial CR Approval Date

09/16/2014 10:24:32

CN Number

CN133553

CA Number

CA155205

NPD Disposition Plan

0000160552, Rev. C Effective Date: Nov 25, 2015 1:43:15 PM

Print Date: Nov 25, 2015 02:19:13 PM

Summary of Contents for 0703-001-000

Page 1: ...bels or IFUs Description Type Stryker Instruments 269 323 7700 800 253 3210 Print Location Suppliers Services Part Number Rev 8 5 inch width x 11 inch Booklet Print Center Color Graphics on White Background 20 Bond or Equivalent N A N A Instructions For Use 0703 001 700 C 0000160552 Rev C Effective Date Nov 25 2015 1 43 15 PM Print Date Nov 25 2015 02 19 13 PM Item 2 ...

Page 2: ... www stryker com Neptune 3 Waste Management System 120 VAC Rover 0703 001 000 Instructions For Use ENGLISH EN Software Version 002 003 xxx 0000160552 Rev C Effective Date Nov 25 2015 1 43 15 PM Print Date Nov 25 2015 02 19 13 PM ...

Page 3: ...ion or in service training contact your Stryker sales representative or call Neptune Customer Service at 1 800 550 7836 WARNING DO NOT connect directly to chest tubes DO NOT connect to closed wound drains DO NOT connect directly to tracheal tubes ALWAYS use the minimum suction limit required to achieve the desired clinical outcome 0000160552 Rev C Effective Date Nov 25 2015 1 43 15 PM Print Date N...

Page 4: ...tion devices Stryker has received reports that high suction devices have been connected directly to patients chest tubes postoperatively which resulted in deaths Stryker has received reports that high suction devices have been connected to patients closed wound drains postoperatively which resulted in serious patient injuries Do not connect the Neptune 3 Rover directly to a patient s chest tube Do...

Page 5: ... Add Canister Prefill Fluid 28 8 1 3 To Test the Rover 28 8 1 3 1 To Connect Power to the Rover 28 8 1 3 2 To Test Fluid Suction 28 8 1 3 3 To Test IV Pole Height Adjustment 30 8 1 3 4 To Test Smoke Evacuation 30 8 1 4 To Adjust the Rover Settings 31 8 2 Before the Procedure 32 8 2 1 To Prepare the Rover 32 8 2 2 To Install Disposable Components 33 8 2 2 1 To Prepare for Fluid Suction 33 8 2 2 2 T...

Page 6: ...2 Docking Station Operation 50 13 3 Troubleshooting Codes 52 14 Specifications 54 15 Electromagnetic Compatibility 56 16 Federal Communications Commission FCC Statement Concerning Radio Frequency Interference 58 16 1 Manifold Authentication 58 16 1 1 FCC Compliance 58 16 1 2 Radio License 58 16 2 Docking Interface 58 16 2 1 FCC Compliance 58 17 Glossary 59 18 Software License Notices 59 0000160552...

Page 7: ... the Canisters 11 Figure 5 To Evacuate Surgical Smoke 11 Figure 6 To Adjust IV Pole Height 11 Figure 7 Components and Interface Diagram 12 Figure 8 Rover Front View 14 Figure 9 Rover Back View 15 Figure 10 Top Display WARNING Screen 16 Figure 11 Main Display WARNING Screen 16 Figure 12 Control Screen Menu Structure 17 Figure 13 Roving Mode Control Screen 18 Figure 14 Accessories Dialog 19 Figure 1...

Page 8: ...ly with this information to prevent product damage NOTE A note supplements and or clarifies procedural information 1 3 Contact Information For additional information including safety information or in service training contact your Stryker sales representative or call Stryker Neptune Customer Service at 1 800 550 7836 Outside the US contact your nearest Stryker subsidiary 2 Indications For Use The ...

Page 9: ...ied environmental condition values See Section 14 Specifications The collection canister scale top display and main display are not diagnostic tools DO NOT use the scale or either display to determine the amount of fluid lost from or retained by the patient DO NOT cover the top display or main display with drapes or other objects ALWAYS make sure the top display and main display can be clearly see...

Page 10: ...en Exposure Control Plan The Exposure Control Plan is designed to eliminate or minimize employee exposure through use of personal protective equipment PPE appropriate vaccinations for example hepatitis B and other control measures ALWAYS wear PPE when operating or handling this equipment ALWAYS follow local regulations regarding proper handling and disposal of biohazard waste Failure to comply may...

Page 11: ...p exhaust and canister exhaust are filtered Figure 1 To Collect Fluid Waste Manifolds and suction tubing are single use disposables and must be replaced between patients However it may not be necessary to empty the contents of the rover s collection canisters If the rover display indicates sufficient fluid volume capacity in one or both canisters the rover may be used for additional surgical proce...

Page 12: ... also be evacuated from the surgical site through smoke tubing connected to the smoke evacuator filter installed in the rover The surgical smoke is filtered inside the rover Figure 5 Figure 5 To Evacuate Surgical Smoke The height of the IV pole may be adjusted by touching and holding buttons on the control screen Figure 6 Figure 6 To Adjust IV Pole Height 0000160552 Rev C Effective Date Nov 25 201...

Page 13: ...unctionality and provides audible visual and tactile feedback of status The user interface elements include one main display with touch capability two suction control dials two manifold receptacle suction indicators and one top display Figure 7 Figure 8 and Figure 9 Speaker Suction Dials ROVER DOCKER Communication Window Docker Interface Communication Windows Required Components User Interface Rov...

Page 14: ...40 000 Smoke Tubing Medical grade smoke evacuator tubing with a 1 4 inch 3 8 inch or 7 8 inch connector Commercially available Smoke Evacuator Tubing 3 8 inch x 10 feet 10 pack 0702 045 023 Smoke Evacuator Tubing 7 8 inch x 10 feet 10 pack 0700 025 000 Smoke Evacuator Tubing 7 8 inch x 10 feet with Wand 10 pack 0700 026 000 NOTE For a complete list of components and accessories or ordering informa...

Page 15: ...DEVICE DO NOT connect directly to chest tubes or other closed wound drains Failure to comply could result in serious injury or death F Manifold Receptacle two Allows installation of a disposable manifold into the canister The installation or removal of a valid manifold enables or disables suction respectively See Section 17 Glossary for the definitions of a valid and invalid manifold The receptacl...

Page 16: ...and Figure 13 S 4 Liter Suction Control Dial Allows for the rotary adjustment of the suction LIMIT value of the 4 liter canister clockwise increases the value and counterclockwise decreases the value The suction value will appear on the main display as a LIMIT value See Table 5 Suction Limit Ranges and Colors T 20 Liter Suction Control Dial Allows for the rotary adjustment of the suction LIMIT val...

Page 17: ...the minimum suction limit required to achieve the desired clinical outcome Confirm I have read and understand the safety warnings WARNING 002 003 000 Figure 11 Main Display WARNING Screen NOTE The software version number appears in the upper right corner of the main display WARNING screen Make sure the number on the screen matches the software version number on the cover of this instructions for u...

Page 18: ...s Figure 12 Evacuate Smoke IV Pole Power Reset Volumes Settings Start Suction 4L Light Empty 4L Canister Stop Suction Normal Wash Quick Wash Extended Wash Manifolds Filters Display Sounds Lights Docking Preferences Accessories On Auto Off Figure 12 Control Screen Menu Structure 0000160552 Rev C Effective Date Nov 25 2015 1 43 15 PM Print Date Nov 25 2015 02 19 13 PM ...

Page 19: ...lso provides fluid volume information via a 4L or 20L canister symbol and a fluid volume reading If the canisters volumes are reset the words since last reset will appear See Table 9 Canister Symbol Colors F Suction Status Area two Indicates the suction status of a canister including STOPPED PAUSED or HIGH G Manifold Indicator Area two Indicates the status of the manifold installed in the receptac...

Page 20: ...Options Area Provides options that may be adjusted as well as default settings information or life cycle use information C Tab Selection Area Provides selection tabs including FILTERS MANIFOLDS SOUNDS DISPLAYS and LIGHTS D Title Area Indicates the name of the settings dialog including DOCKING ACCESSORIES and PREFERENCES E Option Adjustment Area s Provides buttons used to adjust sound or brightness...

Page 21: ...Manual selection will override the default cycle setting C Notification Message Area Indicates when a low priority alarm condition has occurred Figure 16 touch to access the drop down list and or message D Error Message Area Indicates when a medium priority alarm condition has occurred touch to access the drop down list and or message E Title Area Indicates the name of the screen F Status Area Pro...

Page 22: ...button to exit a notification or error drop down B List Area Provides one or more notification message or error message buttons Each button allows access to a specific message C Navigation Area Provides UP and DOWN buttons to scroll through a list of notification message or error message buttons D Title Area Identifies the type of message displayed either notification or error E Message Area Provi...

Page 23: ...cates the status of the manifold installed in the receptacle Status conditions include new or used See Table 8 Manifold Symbol Colors C Fluid Volume Status Area two Indicates fluid volume status information of a specific canister Conditions include EMPTYING PREFILLING ALMOST FULL FULL or ERROR D Suction Status Area two Indicates the suction status of a canister including STOPPED PAUSED LOW MEDium ...

Page 24: ... ENABLED Touch the toggle button to enable or disable the AUTO mode of smoke evacuation In the AUTO mode evacuation will increase to its set power value within five seconds of smoke detection Evacuation will decrease to a 10 power value within 30 seconds of smoke cessation The AUTO mode is not available unless a smoke evacuator ULPA filter is installed correctly Empty 4L canister EMPTY 4L CANISTER...

Page 25: ...ab to access the SOUNDS status information and volume control The volume or loudness of audible indicators may be increased or decreased Display DISPLAY Touch the tab to access the DISPLAY status information and brightness control The brightness of the top display and main display may be increased or decreased Lights LIGHTS Touch the tab to access the LIGHTS status information and brightness contr...

Page 26: ...d are provided Extended Wash EXTENDED WASH Touch the button to select the EXTENDED WASH cycle option A cycle description and when the cycle was last performed are provided Start START Touch the button to initiate the QUICK WASH cycle the NORMAL WASH cycle or the EXTENDED WASH cycle Figure 46 See Table 18 Docking Cycle Options Cancel CANCEL Touch the button to stop docking and prepare the rover for...

Page 27: ...TION FILTER COMPARTMENT SMOKE FILTER COMPARTMENT Table 4 Symbols This table defines the symbols located on the equipment and or labeling Also see the Symbol Definition Chart supplied with the equipment for more definitions SYMBOL DEFINITION ON POWER OFF POWER POWERED IV POLE HEIGHT ADJUSTMENT DOWN DECREASE UP INCREASE EVACUATE SMOKE OFF ON EMPTY FOUR LITER CANISTER RESET VOLUMES FOUR LITER CANISTE...

Page 28: ... on the control screen COLOR DEFINITION White Indicates fluid volume SINCE last reset Grey Indicates fluid volume BEFORE last reset Blue Indicates fluid volume ALMOST FULL Yellow Indicates fluid volume FULL Table 10 Message Area Colors This table defines the color of the notification and error message areas used on the control screen COLOR DEFINITION Blue Indicates LOW PRIORITY alarm Yellow Indica...

Page 29: ...8 1 2 To Add Canister Prefill Fluid NOTE Before the rover may be tested and placed into use initial docking is required Initial docking will add prefill fluid to the canisters See Section 8 4 3 To Dock the Rover Failure to comply will result in prefill errors and prevent the rover from operating properly See Section 17 Glossary for definition of prefill fluid 8 1 3 To Test the Rover 8 1 3 1 To Con...

Page 30: ...e control screen Figure 13 changes and reaches a suction level of at least 494 mm Hg If not see Section 13 Troubleshooting 7 Repeat this procedure to test the other canister 8 Discard the manifold used for testing purposes Evacuate Smoke Insert manifold Reset Volumes 20 L 0 mL Settings Start Suction Set up system Turn clockwise Insert manifold Turn clockwise 4 L 0 mL 4L Light Empty 4L Canister Fig...

Page 31: ... installation into the rover See Table 14 Smoke Evacuator Modes of Operation for mode descriptions Make sure the ON or AUTO mode is selected Table 14 Smoke Evacuator Modes of Operation MODE DESCRIPTION OFF Stops smoke evacuator operation ON Evacuates continuously at the specified power setting whether smoke is present or not AUTO Increases smoke evacuation to the specified power setting when smoke...

Page 32: ...on to accept any selection or adjustment and exit the dialog Touch the BACK button to cancel any selection or adjustment and exit the dialog Set up system Back Close Preferences Display Lights Top Display Brightness Main Display Brightness Sounds Figure 24 Preferences Dialog Table 15 Rover Settings Options DOCKING OPTIONS Quick Wash Set As Default Normal Wash Set As Default Extended Wash Set As De...

Page 33: ...e of the initial prefill fluid in the canister s is accounted for in the fluid level value indicated on the top display Foam does not affect this fluid level value ALWAYS close unused manifold ports and remove or clamp unused tubing to maintain optimal suction levels The suction level in each canister is affected by the suction demand on the other canister If the 4 liter or 20 liter suction limit ...

Page 34: ... manifold s clockwise to lock into the manifold receptacles See the instructions for use supplied with the manifold 3 Attach the fluid suction tubing to the port s of the installed manifold s ALWAYS close unused manifold ports 4 Attach a fluid suction accessory to the end of the suction tubing if desired Figure 26 To Prepare for Fluid Suction 5 From the control screen touch the RESET VOLUME button...

Page 35: ...8 2 Install a smoke evacuator attachment to the end of the smoke tubing if desired 3 Adjust smoke evacuator power as required See Section 8 1 3 4 To Test Smoke Evacuation Figure 28 To Prepare for Smoke Evacuation 8 2 2 3 To Prepare the IV Pole NOTE The powered IV pole will return to its lowest position automatically when power is removed from the rover 1 Hang only one fluid bag per IV pole hook if...

Page 36: ...ON whether accidental or intentional does not reset the suction limit range to zero See BS EN ISO 10079 1 2009 clause 13 8 Use caution when activating suction with a high suction limit range Death or serious injury can result from the improper application of suction levels The collection canister scale top display and main display are not diagnostic tools DO NOT use the scale or either display to ...

Page 37: ...m Hg Two declining tones orange HIGH suction banner appears for appropriate canister on the top display and main display suction range indicator illuminates orange for associated canister Determine whether a high suction range is desired 8 3 1 2 To Control Smoke Evacuation CAUTION DO NOT use the smoke evacuator to evacuate or suction surgical fluid Excessive amounts of fluid pulled into the smoke ...

Page 38: ...rnate suction source Dock the rover to dispose of waste See Section 8 4 3 To Dock the Rover NOTES A maximum of three EMPTY 4L CANISTER cycles are allowed between docking cycles The number of EMPTY 4L CANISTER cycles remaining is shown on the EMPTY 4L CANISTER dialog The fluid volume values shown on the top display and main display will change after the EMPTY 4L CANISTER action is complete Prefill ...

Page 39: ...NISTER button An EMPTY 4L CANISTER dialog will appear Figure 33 Touch the CONFIRM button if the loss of suction will not compromise patient safety Suction ON Cancel Confirm Empty 4L Canister Empty 4L canister into 20L canister All suction will stop for 30 SECONDS while 4 L canister empties Number of empties remaining 2 Figure 33 Empty 4 Liter Canister Dialog NOTE Status of the emptying and prefill...

Page 40: ...igure 36 Figure 36 To Relocate the Manifold 3 If the 20 liter canister is full shut down the rover for docking See Section 8 4 1 To Remove Disposable Components and Section 8 4 2 To Shut Down and Relocate the Rover Dock the rover to empty the full canister s See Section 8 4 3 To Dock the Rover 0000160552 Rev C Effective Date Nov 25 2015 1 43 15 PM Print Date Nov 25 2015 02 19 13 PM ...

Page 41: ... any attached suction tubing from the manifold Figure 37 2 From the control panel turn the suction control dial to zero for the canister with the manifold to be removed Figure 38 3 From the control screen touch the STOP SUCTION button to stop fluid suction 4 Rotate the manifold counterclockwise within the receptacle until it is unlocked then pull the manifold and attached suction tubing out of the...

Page 42: ...d attachment Figure 40 To Remove Evacuator Components 8 4 1 3 To Remove Fluid Bag s 1 From the control screen menu touch and hold the IV pole DOWN button to lower the fluid bag s To automatically lower the powered IV pole push the power switch to the OFF position Figure 41 2 Remove all fluid bag s from the IV pole hooks Figure 41 To Remove Fluid Bag s 8 4 2 To Shut Down and Relocate the Rover 8 4 ...

Page 43: ... Prepare the Rover NOTES ALWAYS use the rover handle when repositioning or relocating the rover Dock the rover for waste disposal as soon as possible typically within two hours of the last use to preclude extended wash cycles The rover is not required to be connected to facility power when not in use 8 4 3 To Dock the Rover WARNINGS PINCH POINT HAZARD ALWAYS keep hands out and away from the mating...

Page 44: ...le Options 1 Push the rover toward the docker and between the docker guides until the rover and docker attach automatically Figure 45 DO NOT lock the casters The DOCKING MODE screen will appear Figure 15 2 If another cycle option is selected before the initiation of the default cycle touch the START button to initiate the selected cycle Figure 46 NOTE During the cycle a progress message will appea...

Page 45: ...g the breakdown of fluid waste collected during the rover s next use If this is the initial docking of the rover make sure the rover is tested before use See Section 8 1 3 To Test the Rover NOTES During the first rover docking procedure the information on the main display may appear inconsistent The procedure may also take a few more minutes than specified in Table 18 Docking Cycle Options Both co...

Page 46: ...rover and docker operate properly See the following Section 8 4 3 To Dock the Rover Section 8 1 3 To Test the Rover and Section 8 1 4 To Adjust the Rover Settings Before each use and after each cleaning and disinfection Inspect equipment for damage or missing components If damage is apparent replace the equipment See Section 5 3 For Use With INTERVAL CRITERIA ACTION Before each use and after each ...

Page 47: ...th for ordering information 6 If the rover will be used again use the rover handle to push and relocate the rover See Section 8 2 1 To Prepare the Rover If the rover will no longer be used use the rover handle to push and relocate the rover to a storage area See Section 11 Storage and Handling INTERVAL CRITERIA ACTION Six months Inspect the replacement date on the label of the fluid suction filter...

Page 48: ...use the expansion of frozen internal fluid to damage the equipment NOTE The rover does not have to be connected to facility power when not in use 12 Disposal Recycle WARNING BLOODBORNE PATHOGEN AND CONTAMINATION HAZARDS ALWAYS follow local regulations for safe handling recycling and disposal of biohazardous fluid waste and Neptune equipment Call Neptune Customer Service for rover decontamination p...

Page 49: ...fold ports are open Close all unused inlet ports of the manifold installed in each canister Suction tubing connection is not secure Make sure all suction tubing connections are secure Unused suction tubing is not clamped Clamp any suction tubing not in use Suction tubing is blocked or damaged Clear or replace any suction tubing in use Suction accessory is blocked or damaged Clear or replace the su...

Page 50: ...on 1 3 Contact Information IV pole height cannot be adjusted to its maximum height IV pole is supporting too much weight Remove excessive weight from the IV pole See Section 14 Specifications IV pole motor has overheated Wait 10 minutes Touch and hold the UP or DOWN button to adjust the IV pole height The IV pole is bent kinked or pinched Remove the rover from use Contact Stryker Neptune Customer ...

Page 51: ... obstruction from the docker s infrared communication windows Make sure there are no tubes hoses or towels covering the docker s infrared communication windows Dock the rover The docker is not receiving facility water Make sure the water inlet hose is connected correctly and the facility water supply valve is open Dock the rover The docker requires a power reset Remove power then apply power to th...

Page 52: ...tors prevent the removal of the rover from the docker Remove power from the docker apply power to the docker Wait 20 seconds Remove the rover from the docker Cycle docker power Wait 60 seconds try docking the rover again If the problem persists the fluid connectors may be damaged Contact Stryker Neptune Customer Service See Section 1 3 Contact Information The rover cannot be removed from docker Th...

Page 53: ...all service 3 5 Prefill Error MEDIUM Make sure facility water is supplied to the docker dock the rover again 3 6 3 7 Coupling Error MEDIUM Call service 3 9 CODE MESSAGE PRIORITY ACTION 3 12 Dock Incomplete LOW Remove the rover from the docker Cycle docker power Wait 60 seconds try docking the rover again 3 13 Docker Not Ready MEDIUM Remove the rover from the docker Cycle docker power Wait 60 secon...

Page 54: ...M Use an alternate source of suction or empty the 4L canister to restore lost suction to the 4L canister 18 6 20L Full MEDIUM Use an alternate source of suction or dock the rover to empty the 20L canister CODE MESSAGE PRIORITY ACTION 20 1 Audio Failure MEDIUM Cycle power to the rover Push the power switch to the OFF position then push the switch to the ON position If this error persists call servi...

Page 55: ...ral Requirements for Basic Safety and Essential Performance IEC 62366 1 2007 First Edition A1 2014 Medical Devices Part 1 Application of Usability Engineering to Medical Devices IEC 60601 1 8 2006 Second Edition AM1 2012 Medical Electrical Equipment Part 1 8 General Requirements for Basic Safety and Essential Performance Collateral Standard General Requirements Tests and Guidance for Alarm Systems...

Page 56: ...t Type Type CF Applied Part Equipment Classification Class I Medical Electrical ME Equipment Ingress Protection IP IPX0 LED Classification IR Communication Window WARNING INVISIBLE LED RADIATION DO NOT VIEW DIRECTLY WITH OPTICAL INSTRUMENTS CLASS 1M LED PRODUCT Viewing the laser output with certain optical instruments for example eye loupes magnifiers and microscopes within a distance of 100 mm ma...

Page 57: ...3 Rover REF 0703 001 000 should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical...

Page 58: ...s than the compliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with the following symbol Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures o...

Page 59: ...n applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures obj...

Page 60: ...L SENSOR a sensor located in each collection canister that determines the current fluid volume level The presence of prefill fluid ensures the sensor is always floating FLUID STACKING if the rover has sufficient fluid volume capacity in one or both collection canisters it may be used for more than one surgical procedure fluid waste is stacked between procedures GLUTARALDEHYDE a toxic chemical used...

Page 61: ... 001 700 Rev C www stryker com Stryker Instruments 4100 E Milham Kalamazoo Michigan USA 49001 1 269 323 7700 1 800 253 3210 0000160552 Rev C Effective Date Nov 25 2015 1 43 15 PM Print Date Nov 25 2015 02 19 13 PM ...

Page 62: ...6 EST Return to Editor C Ciolek Greg Editor 2015 11 19 16 19 33 EST Continue C Yavari Fazel CA_Owner 2015 11 19 16 51 34 EST Continue C Nollar Andrew CA_Marketing Manager 2015 11 19 17 22 26 EST Approve C Wiersema Kim CA_Regulatory Affairs 2015 11 20 08 16 10 EST Approve C Thompson Kristen CA_Clinical Sciences 2015 11 20 08 25 49 EST Approve C Foor Jacob CA_Product Design Engineer 2015 11 20 08 49...

Page 63: ...lated Information CR Number CR0220689 CR Class DMR All Pre Commercial Release Originating Entity INST Kalamazoo Origin New Product Development Initial CR Approval Date 09 16 2014 10 24 32 CN Number CN133553 CA Number CA155205 NPD Disposition Plan 0000160552 Rev C Effective Date Nov 25 2015 1 43 15 PM Print Date Nov 25 2015 02 19 13 PM ...

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