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Stryker 0711-001-000, Инструкция по эксплуатации

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This manual is the most comprehensive source of information for the safe, effective, and compliant use and/or maintenance
of your product. This product is intended for use by trained and experienced healthcare professionals only. Read and
understand this manual before using the product or any component compatible with the product. Contact Stryker for training
as needed.

This manual is a permanent part of the product. Keep this manual for future reference.

The following signal words may be used throughout this manual:

W

WA

AR

RN

NIIN

NG

G -- Highlights a safety-related issue. Always comply with this information to prevent patient and/or healthcare

staff injury.

C

CA

AU

UT

TIIO

ON

N -- Highlights a product reliability issue. Always comply with this information to prevent product damage.

N

No

otte

e -- Supplements and/or clarifies procedural information.

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Stryker Representative

1-269-323-7700, 1-800-253-3210

[email protected]

www.stryker.com

N

No

otte

e -- The user and/or patient should report any serious product-related incident to both the manufacturer and the

Competent Authority of the European Member State where the user and/or patient is established.

EN

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700000969828 Rev-AA

DRAFT 

NOT 

FOR 

SALE

Содержание 0711-001-000

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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