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Stryker 0711-001-000, Instructions For Use Manual

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Stryker 0711-001-000 Instructions For Use Manual Download Page 78

Stryker Corporation or its divisions or other corporate
affiliated entities own, use or have applied for the following
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Stryker Instruments
1941 Stryker Way
Portage, MI 49002
USA

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Stryker European Operations Limited
Anngrove, IDA Business & Technology Park
Carrigtwohill, Co Cork, T45 HX08 Ireland

700000969828 Rev-AA

2021-1

2

DRAFT NOT FOR SALE

Summary of Contents for 0711-001-000

Page 1: ...0V V N Ne ep pt tu un ne e S S R Ro ov ve er r 0711 002 000XX 1 10 00 0V V N Ne ep pt tu un ne e S S R Ro ov ve er r 0711 003 000 1 12 20 0V V N Ne ep pt tu un ne e S S R Ro ov ve er r C CA A 0711 00...

Page 2: ...D R A F T N O T F O R S A L E...

Page 3: ...r Prefill Fluid 31 3 3 To Test the Rover 32 3 4 To Adjust the Settings 34 4 Using Your Product 36 4 1 To Setup the Rover 36 4 2 To Install Disposable Components 37 4 3 To Operate the Rover 40 4 4 To C...

Page 4: ...ous injury or death Always use the minimum suction limit required to achieve the desired clinical outcome Only trained and experienced healthcare professionals may use this equipment Do not remove the...

Page 5: ...with operating high suction devices Stryker has received reports that high suction devices have been connected directly to patients chest tubes postoperatively which resulted in deaths Do not connect...

Page 6: ...ual W WA AR RN NI IN NG G Highlights a safety related issue Always comply with this information to prevent patient and or healthcare staff injury C CA AU UT TI IO ON N Highlights a product reliability...

Page 7: ...y y W WA AR RN NI IN NG G I IN NA AP PP PR RO OP PR RI IA AT TE E C CO ON NN NE EC CT TI IO ON N H HA AZ ZA AR RD DS S Do not connect directly to chest tubes Do not connect to closed wound drains Do n...

Page 8: ...pital grade facility power receptacle with protective earth ground To avoid the risk of electric shock always disconnect this product from facility power before cleaning Do not touch or make contact w...

Page 9: ...omply may cause environmental contamination and result in injury W WA AR RN NI IN NG G I IN NF FE EC CT TI IO ON N H HA AZ ZA AR RD D Always clean and disinfect the rover as indicated upon initial rec...

Page 10: ...cuum level is required conformal patient positioners where sustained minimum vacuum level is required fluid suction power too low during critical part of surgery inability to achieve hemostasis and se...

Page 11: ...such as the Specimen Collection Manifold and 4 Port Manifold The manifold facilitates the collection of surgical tissue and the removal of fluid waste Figure 1 Once suctioned the fluid waste is collec...

Page 12: ...aste Figure 2 The disposal of fluid waste and the cleaning of the rover canister is an automated closed system process that minimizes exposure to blood borne pathogens F Fiig gu ur re e 2 2 T To o D D...

Page 13: ...tr ro oll P Pa an ne ell Includes a touch sensitive display and a suction control dial F F S Sp pe ea ak ke er r Provides audible feedback and status G G S Su uc ct tiio on n R Ra an ng ge e I In nd...

Page 14: ...ing Station 120 VAC 0702 014 000 230V Rover 0711 002 000XX Neptune 2 Docking Station 230 VAC 0702 015 000 100V Rover 0711 003 000 Neptune 2 Docking Station 100 VAC 0702 016 000 T Ta ab blle e 2 2 F Fl...

Page 15: ...000FI 0711 002 000NO 0711 002 000PL 2Switzerland and Liechtenstein Rover selected based on language preference Type J power cord is shipped separately 2 2 4 4 D Do oc cu um me en nt ta at tiio on n W...

Page 16: ...dicator provides color coded information about the suction limit range setting See Suction Limit Ranges and Colors G G M Ma an niif fo olld d R Re ec ce ep pt ta ac clle e Allows for the installation...

Page 17: ...rd d Q QR RC C Provides point of use access to safety information and troubleshooting See Components Supplied with the Rover E E M Ma an niif fo olld d H Ho olld de er r Store new unused single use d...

Page 18: ...C C F Fr ro on nt t H Ho ou us siin ng g Provides an interface between the medical grade tubing and the manifold to facilitate fluid collection D D R Re ea ar r H Ho ou us siin ng g Provides an inter...

Page 19: ...E E R RF FI ID D T Ta ag g Allows for authentication of the manifold before enabling suction use Allows the rover via the user interface to communicate manifold status new used or expired F F S Se ec...

Page 20: ...appear disabled for US customers Settings Start Suction Stop Suction Normal Wash Reset Hours Quick Wash Extended Wash Brightness Sound Display Docking Preferences Manifold Filter Safety Information C...

Page 21: ...No ot te e A passive drain connection warning label instructs users against connecting passive drainage such as chest tube or closed wound drain tube to the Neptune S Waste Management System C A B C F...

Page 22: ...lled in the receptacle Status conditions include new or used See Manifold Symbol Screen Colors D D C Ca an niis st te er r I In nf fo or rm ma at tiio on n A Ar re ea a Provides fluid volume informati...

Page 23: ...uid suction status including SUCTION LIMIT SUCTION STOPPED or HIGH SUCTION Indicates the selected suction LIMIT value in mm Hg Three suction limit ranges are provided including LOW MEDium and HIGH See...

Page 24: ...wash cycle option information see To Dock the Rover page 54 A D B C D F Fiig gu ur re e 1 14 4 N No ot tiif fiic ca at tiio on n D Diia allo og g A Ar re ea as s A A N No ot tiif fiic ca at tiio on n...

Page 25: ...e message code See Troubleshooting Codes page 62 C C M Me es ss sa ag ge e L Liis st t A Ar re ea a Provides specific message information If more than one message appears a list of message buttons app...

Page 26: ...n Touch the UP and DOWN arrows to increase or decrease the brightness of the 8L canister light Canister Light CANISTER LIGHT CONTROL Touch to turn ON or OFF the light inside the 8L canister Change Lan...

Page 27: ...ES button Touch the UP and DOWN arrows to scroll through the available language options Select the appropriate language as required Confirm the selected language The LANGUAGES dialog menu is disabled...

Page 28: ...the Settings page 34 Sound SOUND SETTINGS Touch to access the SETTINGS dialog menu Touch the SOUND button to access the SOUND dialog menu Touch the UP and DOWN arrows to increase or decrease the volum...

Page 29: ...inse the detergent with water Intermittent periods of soaking occur during the cycle NORMAL WASH Touch to drain the contents of the canister apply detergent to the interior walls of the canister and r...

Page 30: ...BO OL L D DE EF FI IN NI IT TI IO ON N Off Power Switch On Power Switch Eject Manifold Button Lock Filter Cover Unlock Filter Cover Align Lock Unlock T Ta ab blle e 9 9 H HE EP PA A F Fiillt te er r...

Page 31: ...D DE EF FI IN NI IT TI IO ON N Indicates SET UP SYSTEM or SUCTION OFF gray Indicates SUCTION ON green Indicates WARNING orange T Ta ab blle e 1 14 4 B Bu ut tt to on n o or r O Op pt tiio on n C Co ol...

Page 32: ...isplay and secondary control panel display button actuation Error Three slow tones three times Any error message Initial Startup Chime tone Startup screen with progress bar Notification Two declining...

Page 33: ...spect the rover and component for damage If any of the components are missing or damaged do not use the equipment See Contact Information page 4 T Ta ab blle e 2 20 0 C Co om mp po on ne en nt ts s S...

Page 34: ...onnect the rover to facility electrical power using the supplied power cord Insert the plug of the power cord through the strain relief hole before connecting the power cord to the rover Figure 16 The...

Page 35: ...l illuminate white NEW or pink USED and suction control will be enabled START SUCTION button enabled See Glossary page 74 for the definitions of a new valid used expired and invalid manifold 3 Make su...

Page 36: ...LD and SUCTION UNITS T Ta ab blle e 2 21 1 B Br riig gh ht tn ne es ss s O Op pt tiio on ns s I IL LL LU UM MI IN NA AT TI IO ON N O OP PT TI IO ON NS S Display Screen Increase Decrease Canister Light...

Page 37: ...6 S Su uc ct tiio on n U Un niit t O Op pt tiio on ns s S SU UC CT TI IO ON N U UN NI IT TS S O OP PT TI IO ON NS S Millimeters of Mercury United States mm Hg Kilopascal International kPA 3 From the...

Page 38: ...structions for use supplied with the docker N No ot te e The volume of the initial prefill fluid in the canister is accounted for in the fluid level value indicated on the main control panel display F...

Page 39: ...opped or mishandled Failure to comply may cause leakage and result in patient and or healthcare staff injury F Fiig gu ur re e 2 20 0 D Do o N No ot t D Dr ro op p t th he e M Ma an niif fo olld d W W...

Page 40: ...ropriate manifold port s N No ot te e Always close unused manifold ports during use and remove or clamp unused tubing to maintain optimal suction levels Failure to close all the unused manifold ports...

Page 41: ...ocedure fluid volume readout After the fluid volume is reset the rover will display the amount of fluid if any the rover has collected since the last procedure 5 If the procedure fluid volume measurem...

Page 42: ...ot for use as a suction source for Intermittent suction applications Patient positioner devices and Organ stabilizer positioner devices Death or serious injury can result from inappropriate connection...

Page 43: ...control dial to the level of suction required Figure 25 2 Touch the START SUCTION button to start fluid suction N No ot te e After suction has started the STOP SUCTION button may be touched to stop fl...

Page 44: ...vel gauge indicator appears on the secondary control panel display Figure 26 Prepare to switch to an alternate suction source C CA AN NI IS ST TE ER R F FU UL LL L The fluid volume level is at maximum...

Page 45: ...manifold is installed in the rover and connected properly See To Install Disposable Components page 37 N No ot te e If using a specimen collection manifold make sure the suction tubing is connected to...

Page 46: ...the manifold Figure 29 F Fiig gu ur re e 2 29 9 R Re em mo ov ve e S Sp pe ec ciim me en n C Co olllle ec ct tiio on n T Tr ra ay y N No ot te e To maintain suction after removing the collection tray...

Page 47: ...eans of specimen collection 1 To access the secondary specimen collection basket in the manifold touch the STOP SUCTION button on the main control panel display to stop fluid suction Figure 30 Disconn...

Page 48: ...located on the work surface of the rover N No ot te e If suction is required immediately a new manifold may be installed into the rover directly after removing the first manifold N No ot te e If suct...

Page 49: ...ister N No ot te e If sufficient fluid volume capacity exists in the canister the rover may be used for additional surgical procedures 1 With suction active gather the suction tubing toward the manifo...

Page 50: ...om the rover Figure 37 F Fiig gu ur re e 3 37 7 G Ga at th he er r t th he e S Su uc ct tiio on n C Co om mp po on ne en nt ts s 5 Maintaining the manifold in a horizontal orientation properly dispose...

Page 51: ...ity electrical power Wrap the power cord around the cord bracket 3 Unlock the casters of the rover Make sure all four casters are unlocked F Fiig gu ur re e 3 38 8 R Re em mo ov ve e t th he e P Po ow...

Page 52: ...nst Hepatitis B The following disinfectants have been validated for use on the exterior surfaces of the Stryker Neptune 3 Waste Management System Sodium Hypochlorite Based Clorox Clean Up Disinfectant...

Page 53: ...act your nearest Stryker subsidiary N No ot te e Maintenance documentation for this equipment is available upon request to Stryker authorized service personnel only N No ot te e Routine and careful in...

Page 54: ...control panel display See For Use With page 12 and To Replace the HEPA Filter page 52 N No ot te e If any component must be discarded see Disposal Recycle page 65 5 5 3 3 T To o R Re ep plla ac ce e t...

Page 55: ...ilter compartment 7 Install the filter cover over the filter compartment turn the filter cover clockwise to align the arrow in the lock position 5 5 3 3 2 2 T To o V Ve er riif fy y P Pr ro op pe er r...

Page 56: ...inside the canister after the wash cycle is complete Prefill contains a specified amount of detergent for initiating the breakdown of fluid waste collected during rover use After completing the wash c...

Page 57: ...is connected to the docker N No ot te e The end of the inlet tube must be located at the bottom of the detergent bottle See the instructions for use supplied with the detergent bottle 3 Makes sure the...

Page 58: ...T TO ON N C CY YC CL LE ES S D DE ES SC CR RI IP PT TI IO ON N T TI IM ME E A AP PP PR RO OX XI IM MA AT TE E Quick Wash Cycle drains the contents of the canister applies detergent to the interior wa...

Page 59: ...e ec co on nd da ar ry y C Co on nt tr ro oll P Pa an ne ell D Diis sp plla ay y W Wa as sh h C Cy yc clle e C Co ou un nt t D Do ow wn n 5 When the wash cycle is complete press the Release button to...

Page 60: ...h is in the ON position Power cord is not connected or is not connected securely Connect the supplied power cord or make sure the power cord is connected securely See Facility power is not available o...

Page 61: ...he fluid suction filter has exceeded its useful life Replace the HEPA fluid suction filter See For Use With page 12 See To Replace the HEPA Filter page 52 The rover is releasing a strong odor The flui...

Page 62: ...Remove any 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 See To Dock th...

Page 63: ...the rover is docked and the rover cannot be removed from the docker The fluid connectors prevent the removal of the rover from the docker Remove power from the docker apply power to the docker Wait 20...

Page 64: ...efault docking cycle require resetting See To Adjust the Settings page 34 1 2 Collected data erased This includes manifolds used filter hours and last docking cycle 1 X Memory Error Error medium Call...

Page 65: ...filter reset filter life counter See To Replace the HEPA Filter page 52 6 X Empty Tank Error Error medium Call service See Contact Information page 4 7 X Level Sensor Error Error medium Call service S...

Page 66: ...ON position If this error persists call service 21 0 Dial Error Error medium Call service See Contact Information page 4 22 0 Manifold Error Error medium Call service See Contact Information page 4 22...

Page 67: ...st Stryker subsidiary 1 Contact your local Stryker service center to obtain a repair purchase order BEFORE sending a product return directly to the center 2 To expedite your processing ALWAYS include...

Page 68: ...Hg measured with all ports closed N No ot te e Suction limits remain adjustable in increments of 5 mm Hg for settings between 50 to 120mm Hg Suction limits increment at 20 mm Hg for settings over 120...

Page 69: ...inch width XXX mm X X inch length M Ma as ss s XX kg XX lb M Ma at te er riia all M Mo od de ell Neptune S V2 4 Port Manifold REF 0750 400 000 D Diim me en ns siio on ns s XX mm X X inch height XX mm...

Page 70: ...0711 002 000XX 0711 003 000 R Ra at tiin ng gs s Current 15 A 10 A minimum 16 A Voltage nominal 125 VAC 250 VAC 110 VAC minimum Frequency 60 Hz 50 Hz 50 60 Hz Temperature 105 C minimum C Co on nd du u...

Page 71: ...851 025 CEE 7 7 G Unshielded 3 0 m 5 5 m YES 0996 851 027 BS 1363 L Unshielded 2 5 m 5 5 m NO YES 0996 851 032 CEI 23 50 1The facility power mains plug shall have a ground earthing pin 2The power cord...

Page 72: ...eptune S Rover or shielding the location Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Complies G Gu uiid da an nc ce e a an nd d m ma an nu uf fa ac ct...

Page 73: ...er requires continued operation during power mains interruptions it is recommended that the Neptune S Rover be powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz magnet...

Page 74: ...ulation 217 Hz Maximum power 2 W b 3 V m 80 MHz to 2 7 GHz 80 AM at 1 kHz 27 V m 385 MHz pulse modulation 18 Hz Maximum power 1 8 W 28 V m 450 MHz FM 5 kHz deviation 1 kHz sine Maximum power 2 W 9 V m...

Page 75: ...people Pour garantir la conformit aux exigences d exposition RF de la FCC et d ISED Canada cet appareil doit tre install de mani re laisser un minimum de 20 cm entre l appareil et les personnes N No o...

Page 76: ...r elements 1 docker electromagnets attract and hold the rover strike plates to facilitate physical connection 2 the docker power coupler provides electrical energy to the rover during docking 3 rover...

Page 77: ...Va alliid d M Ma an niif fo olld d a NEW or USED manifold but not yet expired I In nf fr ra ar re ed d C Co om mm mu un niic ca at tiio on n an information exchange method using a receiver a transmitt...

Page 78: ...lders M Ma an nu uf fa ac ct tu ur re ed d B By y Stryker Instruments 1941 Stryker Way Portage MI 49002 USA A Au ut th ho or riiz ze ed d R Re ep pr re es se en nt ta at tiiv ve e iin n t th he e E Eu...

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