FCC ID: Q9R-492866 RFID tag reader

NNeeppttuunnee SS WWaassttee MMaannaaggeemmeenntt SSyysstteemm IInnssttrruuccttiioonnss FFoorr UUssee 112200VV NNeeppttuunnee SS RRoovveerr ((UUSS)) 0711-001-000 223300VV NNeeppttuunnee SS RRoovveerr 0711-002-000XX 110000VV NNeeppttuunnee SS RRoovveerr 112200VV NNeeppttuunnee SS RRoovveerr ((CCAA)) 0711-003-000 0711-004-000 VV22 SSppeecciimmeenn CCoolllleeccttiioonn MMaanniiffoolldd KKiitt 0750-200-000 VV22 44--PPoorrtt MMaanniiffoolldd 0750-200-000 700000969828 Rev-AA 2021-12 EN DRAFT NOT FOR SALE DRAFT NOT FOR SALE TTaabbllee ooff CCoonntteennttss 1 Important Information.............................................................................................................................................2 1.1 WARNINGS ......................................................................................................................................................2 1.2 Known Use Errors .............................................................................................................................................3 1.3 Using this Manual ..............................................................................................................................................4 1.4 Contact Information ...........................................................................................................................................4 1.5 Safety Directives ...............................................................................................................................................5 1.6 Indications For Use............................................................................................................................................8 1.7 Contraindications ..............................................................................................................................................8 1.8 Intended Users..................................................................................................................................................8 1.9 Patient Profile....................................................................................................................................................8 2 Product Overview ..................................................................................................................................................9 2.1 System Operation..............................................................................................................................................9 2.2 System Components and Interface ...................................................................................................................11 2.3 For Use With ...................................................................................................................................................12 2.4 Documentation................................................................................................................................................13 2.5 Features Hardware......................................................................................................................................14 2.6 Features Software Menu..............................................................................................................................18 2.7 Features Software Screens..........................................................................................................................19 2.8 Definitions.......................................................................................................................................................24 3 Getting Started.....................................................................................................................................................31 3.1 To Unpack the Rover .......................................................................................................................................31 3.2 To Add Canister 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 Collect a Specimen .....................................................................................................................................43 4.5 To Shut Down the Rover ..................................................................................................................................47 5 After Use ..............................................................................................................................................................50 5.1 To Clean and Disinfect the Rover......................................................................................................................50 5.2 To Inspect the Equipment ................................................................................................................................51 5.3 To Replace the HEPA Filter..............................................................................................................................52 5.4 To Dock the Rover...........................................................................................................................................54 6 References...........................................................................................................................................................58 6.1 Storage and Handling ......................................................................................................................................58 6.2 Troubleshooting ..............................................................................................................................................58 6.3 Troubleshooting Codes....................................................................................................................................62 6.4 Service ...........................................................................................................................................................65 6.5 Disposal/Recycle.............................................................................................................................................65 6.6 Specifications..................................................................................................................................................66 6.7 Power Cord Specifications ...............................................................................................................................68 6.8 Electromagnetic Compatibility ..........................................................................................................................70 6.9 Federal Communications Commission (FCC) and Industry Canada (IC) Compliance............................................73 6.10 Glossary .......................................................................................................................................................74 700000969828 Rev-AA 1 EN DRAFT NOT FOR SALE 11.. IImmppoorrttaanntt IInnffoorrmmaattiioonn 11..11.. WWAARRNNIINNGGSS WARNING HIGH SUCTION DEVICE Do not connect directly to chest tubes or other closed wound drains. Do not connect directly to tracheal tubes. Failure to comply could result in serious 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 safety card from the equipment. For more information, including safety information or in-service training, contact your Stryker sales representative or call Neptune Customer Service at 1188000055550077883366. EN 2 700000969828 Rev-AA DRAFT NOT FOR SALE 11..22.. KKnnoowwnn UUssee EErrrroorrss Known Use Errors It is important to acknowledge and be aware of potential hazards associated with high suction devices prior to use. This information highlights known use errors that constitute improper and unsafe use of a high suction device, such as the Neptune Rover. Stryker has received incident reports of serious injury and/or death associated 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 the Neptune Rover directly to a patients chest tube. 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 Rover to a closed wound drainage system. For training information, visit www.neptunecustomercare.com. 700000969828 Rev-AA 3 EN DRAFT NOT FOR SALE 11..33.. UUssiinngg tthhiiss MMaannuuaall 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:

WWAARRNNIINNGG -- Highlights a safety-related issue. Always comply with this information to prevent patient and/or healthcare staff injury. CCAAUUTTIIOONN -- Highlights a product reliability issue. Always comply with this information to prevent product damage. NNoottee -- Supplements and/or clarifies procedural information. 11..44.. CCoonnttaacctt IInnffoorrmmaattiioonn Stryker Representative 1-269-323-7700, 1-800-253-3210 inst.stryker.cs@stryker.com www.stryker.com NNoottee -- 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 4 700000969828 Rev-AA DRAFT NOT FOR SALE 11..55.. SSaaffeettyy DDiirreeccttiivveess GGeenneerraall SSaaffeettyy WWAARRNNIINNGG -- Healthcare professionals should be thoroughly familiar with the instructions for use and the operation of this product prior to use. WWAARRNNIINNGG -- Healthcare professionals should be thoroughly familiar with the performance characteristics, and the indicated, contraindicated, and intended uses of this product. Contact your Stryker sales representative or Stryker Neptune Customer Service for in-service training. WWAARRNNIINNGG -- The healthcare professional performing any procedure is responsible for determining the appropriateness of this product and the specific technique used for each patient. Stryker, as a manufacturer, does not recommend surgical procedure or technique. MMaaggnneettiicc RReessoonnaannccee IImmaaggiinngg ((MMRRII)) SSaaffeettyy WWAARRNNIINNGG -- This product is MR unsafe. Do not use the product in an MRI environment. Operating the product outside the specified environmental conditions could result in death or serious injury. IINNAAPPPPRROOPPRRIIAATTEE CCOONNNNEECCTTIIOONN HHAAZZAARRDDSS Do not connect directly to chest tubes. Do not connect to closed wound drains. Do not connect directly to tracheal tubes. Not 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 connections. CCoonnnneeccttiioonn SSaaffeettyy WWAARRNNIINNGG SSuuccttiioonn SSaaffeettyy WWAARRNNIINNGG HHIIGGHH SSUUCCTTIIOONN HHAAZZAARRDD:: MMAAXXIIMMUUMM == [[552200 mmmm--HHgg]]

Always use the minimum suction limit range required to achieve the desired clinical outcome. Always follow your institutions guidelines for suction limits. The effectiveness of aspiration is dependent upon the intensity of the suction applied. The suction limit range of the collection canister may be adjusted by using the suction control dial on the main control panel. Interruption and restoration of rover power while suction is ON, whether accidental or intentional, does not reset the suction limit range to zero. See BS EN ISO 10079-1: 2015 + A1: 2019, clause 9.11. Use caution when activating suction with a high suction limit range. Death or serious injury can result from improper suction levels. 700000969828 Rev-AA 5 EN DRAFT NOT FOR SALE EElleeccttrriiccaall SSaaffeettyy WWAARRNNIINNGG WWAARRNNIINNGG EEnnvviirroonnmmeennttaall SSaaffeettyy WWAARRNNIINNGG nitrous oxide. WWAARRNNIINNGG EELLEECCTTRROOMMAAGGNNEETTIICC IINNTTEERRFFEERREENNCCEE HHAAZZAARRDD Use only Stryker-approved electronic components and accessories. Failure to comply may result in increased electromagnetic emissions or decreased electromagnetic immunity of the system. Take special precautions regarding electromagnetic compatibility (EMC) when using this product. Install and/or put this product into service per the EMC information contained in this manual. Portable and mobile radio frequency (RF) equipment can affect the function of this product. EELLEECCTTRRIICCAALL SSHHOOCCKK HHAAZZAARRDD To avoid the risk of electric shock, always connect this product to a hospital-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 with this product and the patient simultaneously. Failure to comply may cause electrical shock and result in patient or healthcare staff injury. FFIIRREE HHAAZZAARRDD Do not use this product in areas in which flammable anesthetics or flammable agents are mixed with air, oxygen, or Failure to comply may cause a fire and result in burn injury or property damage. FFLLUUIIDD WWAASSTTEE LLEEAAKKAAGGEE HHAAZZAARRDD Always make sure rover power is ON when collecting fluid waste. The rover can only detect a full canister if the rover power is ON. If rover power is OFF, fluid waste leakage can occur. EN 6 700000969828 Rev-AA DRAFT NOT FOR SALE BBiioollooggiiccaall SSaaffeettyy WWAARRNNIINNGG surgical waste. WWAARRNNIINNGG WWAARRNNIINNGG Always follow the current local regulations and procedures governing biohazard waste to safely handle and dispose of Failure to comply may cause infection and result in healthcare staff injury. CCOONNTTAAMMIINNAATTIIOONN HHAAZZAARRDD Do not collect fluids from patients being treated with radioisotopes or hazardous chemical agents. Always follow the current local recommendations and/or regulations governing environmental protection and the risks associated with recycling or disposing of the product at the end of its useful life. Failure to comply may cause environmental contamination and result in injury. IINNFFEECCTTIIOONN HHAAZZAARRDD Always clean and disinfect the rover as indicated upon initial receipt and before each use. Always keep the rover outside the sterile field. The suction tubing with end-effector are used in the sterile field. Do not reuse, process, or repackage the non-sterile manifold, a single patient use disposable device. The manifold may not withstand chemical, chemical vapor, or high temperature sterilization processing. Design features may make cleaning difficult. Reuse may create a contamination risk and compromise structural integrity, resulting in operational failure during use. Failure to comply may lead to infection or cross-infection and result in patient and/or healthcare staff injury. 700000969828 Rev-AA 7 EN DRAFT NOT FOR SALE 11..66.. IInnddiiccaattiioonnss FFoorr UUssee The Neptune S Waste Management System is indicated for use in procedures where collecting and disposing of fluid waste and capturing suctioned tissue specimens is desired. It is intended to be used in operating rooms, pathology, surgical centers, procedure rooms, and for endoscopic procedures, such as colonoscopies, esophagogastroduodenoscopies

(EGDs), and bronchoscopies. 11..77.. CCoonnttrraaiinnddiiccaattiioonnss The Neptune S Waste Management System is contraindicated against:

Connection directly to chest tubes, and Connection to closed-wound drainage systems. Complications particular to the use of this device are: closed wound drainage where vacuum levels below 50 mm-Hg are required; tissue stabilizers where sustained, minimum vacuum 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 sensitive tissue damage if vacuum power is too high. Key clinical users include the surgeon, circulating nurse, scrub tech/nurse, and anesthetist. For gastrointestinal procedures, users include the gastroenterologist, endoscopy technician, and anesthetist. 11..88.. IInntteennddeedd UUsseerrss 11..99.. PPaattiieenntt PPrrooffiillee The general patient population is anyone subject to general surgery or diagnostic procedures where the device can be used. The patient populations at greatest risk are pediatric/geriatric patients or others with tissue especially sensitive to barotrauma (suction related tissue damage), patients undergoing a procedure where bleeding control could be an issue, and patients at risk for general anesthesia. EN 8 700000969828 Rev-AA DRAFT NOT FOR SALE 22.. PPrroodduucctt OOvveerrvviieeww 22..11.. SSyysstteemm OOppeerraattiioonn The Stryker Neptune S Waste Management System consists of the Neptune S Rover (rover), the Neptune 2 Docking Station (docker), and supporting accessories. The Stryker Neptune S Rover (rover) is a reusable, non-sterile mobile unit that suctions and collects fluid waste during a surgical procedure. Suction is created to facilitate collection via an integrated vacuum pump. Fluid waste is suctioned from the surgical site through suction tubes connected to the inlet port(s) of a disposable, non-

sterile, single patient use manifold installed in the rover. The Neptune S is compatible with various single patient use manifold options, such as the Specimen Collection Manifold and 4Port Manifold. The manifold facilitates the collection of surgical tissue and the removal of fluid waste (Figure 1). Once suctioned, the fluid waste is collected in the 8L canister of the rover during a procedure. The rover provides surgical waste management, fluid volume measurement, and a lighted work surface for specimen collection. Fluid volume measurements are shown on the main control panel display and the secondary control panel display. If the rover display indicates sufficient fluid volume capacity in the canister, the rover may be used for another surgical procedure before waste disposal. Adding fluid from a second procedure on top of the previous procedure is called fluid stacking. See Glossary (page 74). FFiigguurree 11 TToo SSuuccttiioonn aanndd CCoolllleecctt FFlluuiidd WWaassttee 700000969828 Rev-AA 9 EN DRAFT NOT FOR SALE After use in a surgical procedure, the rover is relocated and attached to the docker, which is typically installed in a hospitals waste disposal area. Once the rover is attached, the docker empties the rovers canister of fluid waste for subsequent disposal. Cleaning of the interior of the canister takes place immediately after the removal of fluid waste (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. The rover canister is cleaned using Neptune Docking Detergent REF 0700-001-026 and rinsed with high pressure water to remove any residual fluid waste (Figure 3). FFiigguurree 22 TToo DDiissppoossee ooff FFlluuiidd WWaassttee FFiigguurree 33 TToo CClleeaann tthhee CCaanniisstteerr EN 10 700000969828 Rev-AA DRAFT NOT FOR SALE 22..22.. SSyysstteemm CCoommppoonneennttss aanndd IInntteerrffaaccee FFiigguurree 44 CCoommppoonneennttss aanndd IInntteerrffaaccee DDiiaaggrraamm UUsseerr IInntteerrffaaccee AA CC EE GG HH)) JJ)) LL)) CCaasstteerr LLoocckkss Four locks prevent unintended rover movement. QQuuiicckk RReeffeerreennccee CCaarrdd ((QQRRCC)) Includes safety and troubleshooting information. SSeeccoonnddaarryy CCoonnttrrooll PPaanneell Includes buttons and a display. WWoorrkk SSuurrffaaccee Illuminated work surface facilitates specimen collection. SSppeeaakkeerr Provides audible feedback and status. MMaaiinn CCoonnttrrooll PPaanneell Includes a touch-

sensitive display and a suction control dial. SSuuccttiioonn RRaannggee IInnddiiccaattoorr Provides visual feedback and status. MMaanniiffoolldd Fluid suction manifold is a single-use, disposable device. TTuubbiinngg Fluid suction tubing is a single-use, disposable device. RReeqquuiirreedd CCoommppoonneennttss BB DD FF II)) KK)) FFiilltteerr Fluid suction High Efficiency Particulate Air (HEPA) filter provides air filtration of the air evacuated from the fluid collection canister before the air is vented. EEffffeeccttoorr Suction-end effector is a single-

use disposable device. DDoocckkeerr Neptune 2 Docking Station provides fluid waste transfer to facilitate disposal. 700000969828 Rev-AA 11 EN DCAEGFLH I KJ BDRAFT NOT FOR SALE 22..33.. FFoorr UUssee WWiitthh WWAARRNNIINNGG -- Use only Stryker-approved equipment, unless otherwise specified. WWAARRNNIINNGG -- The manifold is for single patient use only. Do not reuse, reprocess, service, modify, or repackage a single use device. The single use device may not withstand chemical, chemical vapor, or high temperature sterilization reprocessing. Design features may make cleaning difficult. Reuse may create a contamination risk and compromise structural integrity, resulting in operational failure during use. Failure to comply may lead to infection or cross-infection and result in patient and/or healthcare staff injury. NNoottee -- Contact Stryker for a complete list of accessories. TTaabbllee 11 DDoocckkiinngg SSttaattiioonn aanndd AAcccceessssoorriieess DDeessccrriippttiioonn RREEFF Neptune Docking Detergent (2/pack) 0700-001-026 Neptune 2 Docking Station (120 VAC) 0702-014-000 120V Rover (0711001000, 0711004000, 0711 005000) 230V Rover (0711002000XX) Neptune 2 Docking Station (230 VAC) 0702-015-000 100V Rover (0711003000) Neptune 2 Docking Station (100 VAC) 0702-016-000 TTaabbllee 22 FFlluuiidd SSuuccttiioonn FFiilltteerr,, MMaanniiffoollddss,, TTuubbiinngg,, aanndd CCoonnssoollee SSuuppppoorrtt BBrraacckkeett RRoovveerr MMooddeell All rovers RRoovveerr MMooddeell All rovers DDeessccrriippttiioonn RREEFF Fluid Suction HEPA Filter (1 each) 0702-034-000 Neptune S Console Bracket1 V2 Specimen Collection Manifold Kit, includes specimen collection tray 0711500000 0750-200-000 V2 Specimen Collection Tray (50 each) 0750-210-000 V2 4-port Manifold 0750-400-000 Medical grade fluid suction tubing with 3/8-

inch connector Commercially available NNoottee -- NNeeppttuunnee SS CCoonnssoollee BBrraacckkeett11 A Stryker SafeAir Combi or Compact Console may be attached to the iluminated work surface of the rover using this bracket. See the instructions for use supplied with the bracket. NNoottee -- The fluid suction tubing is an applied part. See Glossary (page 74) for definition of applied part. EN 12 700000969828 Rev-AA DRAFT NOT FOR SALE RRoovveerr MMooddeell PPlluugg TTyyppee DDeessccrriippttiioonn RREEFF TTaabbllee 33 PPoowweerr CCoorrddss11 120V Rover (0711-001000, 0711004000, 0711 005000) B (NEMA) 230V Rover (0711-002000EI) I (AS/NZS) 230V Rover (0711-002000EG) 230V Rover (0711-002000EF, 0711002000XX2) E/F 230V Rover (0711-002000DA) 230V Rover (0711-002000ZH) 230V Rover (multiple3) 100V Rover (0711-003000) 1See PowerCordSpecifications (page 68). G K J I (GB) B, JIS 0996-851-511 0996-851-517 0996-851-515 0996-851-512 0996-851-520 0996-851-518 0996-851-519 0996-851-513 20711-002-000FR, 0711-002-000ES, 0711-002-000DE, 0711-002-000IT, 0711-002-000PT, 0711-002-000NL, 0711-002-

000SV, 0711-002-000FI, 0711-002-000NO, 0711-002-000PL 2Switzerland and Liechtenstein Rover selected based on language preference. Type J power cord is shipped separately. 22..44.. DDooccuummeennttaattiioonn WWAARRNNIINNGG -- See the instructions for use supplied with each system component for important information. V2 Specimen Collection (SC) Manifold (ML) 700000969865 IInnssttrruuccttiioonnss ffoorr UUssee Neptune 2 Docking Station (JA) V2 4-Port Manifold (ML) Neptune 2 Docking Station (EN) Neptune 2 Docking Station (FR-CA) RREEFF 700000341844 700000969868 0702-014-700 0702-015-712 Neptune 2 Docking Station (ES/DE/FR/IT/NL) 0702-015-717 Neptune 2 Docking Station (ZH/KO) 0702-015-720 Neptune 2 Docking Station (SV/DA/FI/PT/NO) 0702-015-730 Neptune 2 Docking Station (PL/EL) Fluid Suction HEPA Filter (ML) 0702-015-740 0702-034-700 700000969828 Rev-AA 13 EN DRAFT NOT FOR SALE 22..55.. FFeeaattuurreess HHaarrddwwaarree FFiigguurree 55 RRoovveerr FFrroonntt VViieeww AA DDoocckkiinngg SSttaattiioonn IInntteerrffaaccee Provides a path for fluid waste transfer from the rover to the docker. Provides water and detergent transfer from the docker to the rover. BB SSttrriikkee PPllaatteess Facilitates the physical connection to the dockers electromagnets to hold the rover in place. CC CCoommmmuunniiccaattiioonn WWiinnddooww Allows infrared

(IR) data transfer between the docker and the rover. DD FFlluuiidd SSuuccttiioonn CCaanniisstteerr 88LL ((88--lliitteerr)) Allows for the collection and containment (storage) of fluid waste during a surgical procedure. The canister has interior illumination. EE EEjjeecctt BBuuttttoonn Facilitates the removal of the FF manifold. SSuuccttiioonn LLiimmiitt RRaannggee IInnddiiccaattoorr Ring style indicator provides color-coded information about the suction limit range setting. See Suction Limit Ranges and Colors. GG MMaanniiffoolldd RReecceeppttaaccllee Allows for the installation of a single-use, disposable manifold. HH SSppeecciimmeenn LLiigghhtt Enables user to view the polyp material or tissue captured within the manifold. II SSuuccttiioonn CCoonnttrrooll DDiiaall Used to select

(clockwise to increase, counterclockwise to decrease) the SUCTION LIMIT. Selection determines the maximum suction possible in the canister. Suction will never exceed the selected SUCTION LIMIT. JJ MMaaiinn CCoonnttrrooll PPaanneell DDiissppllaayy Provides interface to start and stop suction via a touch-sensitive, color display. Important alert and status information are also provided. KK HHIIGGHH SSUUCCTTIIOONN DDEEVVIICCEE WWAARRNNIINNGG LLaabbeell LL HHaannddllee Allows for relocation and positioning of the rover. MM CCaasstteerrss ((ffoouurr)) Swivel casters provide mobility for the rover to roll across a floor. All casters have locks to prevent unintended movement. EN 14 700000969828 Rev-AA KDIJLBAMCGFEHDRAFT NOT FOR SALE FFiigguurree 66 RRoovveerr BBaacckk VViieeww AA FFlluuiidd SSuuccttiioonn FFiilltteerr CCoommppaarrttmmeenntt Contains a disposable fluid suction HEPA filter (included). See ToInspecttheEquipment (page 51). BB LLiigghhtteedd WWoorrkk SSuurrffaaccee Provides an illuminated work area to aid in specimen collection. Surface may also support a Stryker smoke evacuation systems when using the console support bracket. See ForUseWith (page 12). CC SSeeccoonnddaarryy CCoonnttrrooll PPaanneell While roving and in use, panel displays procedure fluid volume. While docked, the panel provides buttons to select wash cycle options and displays wash cycle status. DD QQuuiicckk RReeffeerreennccee CCaarrdd ((QQRRCC)) Provides point-of-use access to safety information and troubleshooting. See Components Supplied with the Rover EE MMaanniiffoolldd HHoollddeerr Store new, unused single-

FF PPoowweerr SSwwiittcchh Used to turn the rover ON and OFF. use, disposable manifolds. GG PPoowweerr CCoorrdd RReecceeppttaaccllee Facilitates connection to facility electrical power. HH SSppeecciiffiiccaattiioonn LLaabbeell Identifies the model and part number information. II PPoowweerr CCoorrdd BBrraacckkeett Allows for the wrapping and storage of the supplied power cord. See PowerCordSpecifications (page 68). JJ PPoowweerr CCoorrdd wwiitthh RReettaaiinneerr Used to connect the rover to facility electrical power. Locking feature prevents cord disconnection. KK .SSeerriiaall NNuummbbeerr LLaabbeell Identifies the serial number information of the rover. 700000969828 Rev-AA 15 EN CBDAGHFKJIEDRAFT NOT FOR SALE FFiigguurree 77 VV22 44--PPoorrtt MMaanniiffoolldd AA PPoorrtt ((ffoouurr)) Allows for the connection of multiple lines of suction tubing. BB PPoorrtt CCaapp ((ffoouurr)) Allows for the closure of a manifold port. CC FFrroonntt HHoouussiinngg Provides an interface DD RReeaarr HHoouussiinngg Provides an interface between the manifold and the rovers 8L canister. between the medical-grade tubing and the manifold to facilitate fluid collection. EE RRFFIIDD TTaagg Authenticates the manifold before enabling use. Allows the rover to communicate manifold status (new, used, or expired). EN 16 700000969828 Rev-AA CDEABDRAFT NOT FOR SALE FFiigguurree 88 VV22 SSppeecciimmeenn CCoolllleeccttiioonn ((SSCC)) MMaanniiffoolldd KKiitt ((wwiitthh CCoolllleeccttiioonn TTrraayy)) BB CCoolllleeccttiioonn TTrraayy PPoorrtt Allows for the installation of the collection tray. AA CCoolllleeccttiioonn TTrraayy ((rreemmoovvaabbllee)) Allows for the collection of small tissue specimens in a variety of procedures. Use of the tray allows for continuous suction without removing or reconnecting suction tubing. between the medical-grade tubing and the manifold. Used to facilitate fluid collection. Always attach the suction tube/device to the primary port. EE RRFFIIDD TTaagg Allows for authentication of the FF manifold before enabling suction use. Allows the rover, via the user interface, to communicate manifold status (new, used, or expired). CC PPrriimmaarryy PPoorrtt Provides the main interface DD RReeaarr HHoouussiinngg Provides an interface between the manifold and the rovers 8L canister. SSeeccoonnddaarryy CCoolllleeccttiioonn BBaasskkeett Located in the rear housing, provides a backup collection method for capturing a tissue specimen in case the collection tray is not installed. May also be used a primary collection method for larger specimens. Both the primary port and the auxiliary secondary port lead to the basket. GG FFrroonntt HHoouussiinngg CCaapp Provides access to the HH AAuuxxiilliiaarryy SSeeccoonnddaarryy PPoorrtt Provides a port for specimen basket. secondary suction, if required. II BBoottttoomm PPoorrtt CCaapp Allows for the closure of the bottom port. JJ CCoolllleeccttiioonn TTrraayy PPoorrtt DDoooorr Allows for the closure of the collection tray port when the collection tray is not installed. 700000969828 Rev-AA 17 EN CBDEIJHGAFDRAFT NOT FOR SALE 22..66.. FFeeaattuurreess SSooffttwwaarree MMeennuu The main control panel display has a menu structure that provides access to the key control functions (Figure 9). NNoottee -- The SUCTION UNITS control function is for international customers only and will appear disabled for US customers. FFiigguurree 99 RRoovveerr MMeennuu SSttrruuccttuurree EN 18 700000969828 Rev-AA SettingsStart SuctionStopSuctionNormalWashResetHoursQuickWashExtendedWashBrightnessSoundDisplayDockingPreferencesManifoldFilterSafetyInformationCanisterLightManifoldLightSpecimenLightSurfaceLightLanguagesSuctionUnitsCanisterLightResetVolumeSpecimenLightSurfaceLightDRAFT NOT FOR SALE 22..77.. FFeeaattuurreess SSooffttwwaarree SSccrreeeennss NNoottee -- The software version number appears in the upper right corner of the main control panel display WARNING screen (Figure 10). Make sure the number on the screen matches the software version number on the cover of this instructions for use. If not, contact your Stryker sales representative or call service to obtain the latest instructions for use manual. See ContactInformation (page 4). NNoottee -- 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. AA TTiittllee AArreeaa Indicates WARNING signal word BB MMeessssaaggee AArreeaa Provides important safety information. FFiigguurree 1100 SSaaffeettyy IInnffoorrmmaattiioonn SSccrreeeenn and rover software revision number. CC RReessppoonnssee AArreeaa Provides a CONFIRM button to acknowledge the understanding of safety information and allow use of the rover. 700000969828 Rev-AA 19 EN CABCDRAFT NOT FOR SALE FFiigguurree 1111 SSeett UUpp SSyysstteemm SSccrreeeenn AA TTiittllee AArreeaa Indicates the name of screen and the SETTINGS button. See ToAdjustthe Settings (page 34). BB SSeeccoonnddaarryy OOppeerraattiinngg AArreeaa Provides secondary operating buttons to control functions of the rover. CC IInnssttrruuccttiioonn aanndd SSttaattuuss IInnddiiccaattoorr AArreeaa DD CCaanniisstteerr IInnffoorrmmaattiioonn AArreeaa Provides fluid volume Indicates the status of the manifold installed in the receptacle. Status conditions include new or used. See Manifold Symbol Screen Colors. information via a 8L canister symbol and a fluid volume reading. If the canister volume is reset, the words since last reset will appear. See Fluid Level Gauge/Indicator Colors. NNoottee -- The rover has a main control panel screen and a secondary control panel display. The main control panel display shows the suction level and fluid volume, and provides controls to start and stop suction, reset the fluid volume, and turn on different lights on the rover. EN 20 700000969828 Rev-AA ACDBDRAFT NOT FOR SALE FFiigguurree 1122 MMaaiinn CCoonnttrrooll PPaanneell DDiissppllaayy SSccrreeeenn AA TTiittllee AArreeaa Indicates the name of screen, any BB notification or error indicators, and the SETTINGS button. See ToAdjusttheSettings

(page 34). SSeeccoonnddaarryy OOppeerraattiinngg AArreeaa Provides secondary operating buttons to control functions of the rover. CC SSuuccttiioonn CCoonnttrrooll AArreeaa Provides a START/

DD FFlluuiidd SSuuccttiioonn IInnffoorrmmaattiioonn AArreeaa Indicates the fluid STOP button to control fluid suction. 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 Suction Limit Ranges and Colors. The ACTUAL SUCTION value is displayed and may vary. This value will almost always be lower than the SUCTION LIMIT, but will not exceed the limit. The manifold status (new, used) is also displayed. See Manifold Symbol Screen Colors. EE FFlluuiidd VVoolluummee IInnffoorrmmaattiioonn AArreeaa Indicates the fluid volume collected in mL, including the total fluid collected and the amount of fluid collected since the last reset. A fluid level gauge provides a visual of the fluid volume captured. See Fluid Level Gauge/Indicator Colors. 700000969828 Rev-AA 21 EN ADEBCDRAFT NOT FOR SALE FFiigguurree 1133 SSeeccoonnddaarryy CCoonnttrrooll PPaanneell AA SSttaattuuss AArreeaa Provides fluid volume status during the roving mode, including almost full and full canister messages. During the docked mode, the area provides wash cycle status, including the time remaining for the wash cycle to complete, any potential error messages, and a confirmation of completion. BB WWaasshh CCyyccllee CCoonnttrrooll AArreeaass Allows for the manual selection of a wash cycle option. Manual selection will override the default cycle setting. Also provides a button to abort an active wash cycle and an eject button to detach the rover from the docker after a complete wash cycle. For additional wash cycle option information, see ToDockthe Rover (page 54). AA NNoottiiffiiccaattiioonn MMeessssaaggee IInnddiiccaattoorr AArreeaa Indicates the notification status of the rover and the number of messages. Action may be required. CC MMeessssaaggee//LLiisstt AArreeaa Provides specific message information. If more than one message appears, a list of message buttons appears. Each button allows access to a specific message. FFiigguurree 1144 NNoottiiffiiccaattiioonn DDiiaalloogg AArreeaass BB TTiittllee AArreeaa Identifies the message type and the message code. See TroubleshootingCodes (page 62). DD RReessppoonnssee AArreeaa Provides a CLOSE button to exit a message or drop-down. If more than one message appears, BACK and FORWARD buttons appear to allow scrolling through the message buttons. EN 22 700000969828 Rev-AA ABADBCDDRAFT NOT FOR SALE FFiigguurree 1155 EErrrroorr DDiiaalloogg AArreeaass AA EErrrroorr MMeessssaaggee IInnddiiccaattoorr AArreeaa Indicates the error status of the rover and the number of messages. Action is required. CC MMeessssaaggee//LLiisstt AArreeaa Provides specific message information. If more than one message appears, a list of message buttons appears. Each button allows access to a specific message. BB TTiittllee AArreeaa Identifies the message type and the message code. See TroubleshootingCodes (page 62). DD RReessppoonnssee AArreeaa Provides a CLOSE button to exit a message or drop-down. If more than one message appears, BACK and FORWARD buttons appear to allow scrolling through the message buttons. 700000969828 Rev-AA 23 EN ADBCDDRAFT NOT FOR SALE 22..88.. DDeeffiinniittiioonnss NNoottee -- Additional product and/or labeling symbols are defined in the Symbol Definition Chart supplied with the product. NNoottee -- See Figure 9 for the location of dialog menus and buttons described in Main Control Panel Display Buttons. TTaabbllee 44 MMaaiinn CCoonnttrrooll PPaanneell DDiissppllaayy BBuuttttoonnss BBUUTTTTOONN NNAAMMEE FFUUNNCCTTIIOONN BACK Touch to scroll through error or notification messages. BRIGHTNESS (SETTINGS) From the BRIGHTNESS dialog menu, select one of the brightness adjustment options, including the DISPLAY, CANISTER LIGHT, MANIFOLD LIGHT, (suction range indicator), SPECIMEN LIGHT and SURFACE LIGHT. Brightness may be adjusted (increased or decreased) as required. CANCEL Touch to cancel a dialog selection. CANISTER LIGHT

(BRIGHTNESS) CANISTER LIGHT

(CONTROL) From the BRIGHTNESS dialog menu, touch the CANISTER LIGHT button. Touch the UP and DOWN arrows to increase or decrease the brightness of the 8L canister light. Touch to turn ON or OFF the light inside the 8L canister. CHANGE LANGUAGE CONFIRMATION Touch to apply the selected language. CLOSE Touch to exit a dialog menu or dialog control. CLOSE ERROR MESSAGE Touch to exit an error message. CLOSE NOTIFICATION MESSAGE Touch to exit a notification message. CONFIRM DEFAULT CYCLE

(DOCKING) DISPLAY (BRIGHTNESS) Touch to acknowledge understanding of important safety information or allow the performance of a critical and/or irreversible action. From the DOCKING dialog menu, touch the toggle button to enable or disable the default cycle to be performed when the rover is connected to the docker. The QUICK WASH option is selected as the DEFAULT CYCLE. Touch the SETTINGS button to access the SETTINGS dialog menu. Touch the BRIGHTNESS button to access the BRIGHTNESS dialog menu. Touch the DISPLAY button. Touch the UP and DOWN arrows to increase or decrease the brightness. EN 24 700000969828 Rev-AA BrightnessCancelCanister LightCanister LightChange LanguageCloseCloseConfirmDefault CycleDisplayDRAFT NOT FOR SALE BBUUTTTTOONN NNAAMMEE FFUUNNCCTTIIOONN DOCKING

(PREFERENCES) From the DOCKING dialog menu, select one of the three available wash cycle options as the default cycle to be performed automatically when the rover is connected to the docker. QUICK WASH is the DEFAULT CYCLE selected. DOWN/DECREASE Touch and hold to scroll down a list of options or decrease a setting value. ERROR MESSAGE INDICATOR FILTER (PREFERENCES) Touch to access error message information. A drop-

down list of one or more messages will appear. Touch the FORWARD button or the BACK button to scroll through the error messages as required. Touch to access the FILTER dialog and view the fluid suction HEPA filter status (hours used). Touch the RESET HOURS button after the installation of a new fluid suction HEPA filter to reset the hours used to zero. FORWARD Touch to scroll through error or notification messages. KPA (SUCTION UNITS)

(international models of the rover only) From the SUCTION UNITS dialog menu, touch the toggle button to enable or disable the default suction units. Select the millimeters of mercury (mm-Hg) unit or the kilopascal (kPa) unit, as required. LANGUAGES

(PREFERENCES) MANIFOLD LIGHT

(BRIGHTNESS) MANIFOLD

(PREFERENCES) MM-HG (SUCTION UNITS) NOTIFICATION MESSAGE INDICATOR PREFERENCES

(SETTINGS) RESET HOURS From the PREFERENCES dialog menu, touch the LANGUAGES 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 if suction is ON. From the BRIGHTNESS dialog menu, touch the MANIFOLD LIGHT button. Touch the UP and DOWN arrows to increase or decrease the brightness. From the PREFERENCES dialog menu, touch the MANIFOLD button to view manifold usage during 30 day and 90 day periods. From the SUCTION UNITS dialog menu, touch the toggle button to enable or disable the default suction units. Select the millimeters of mercury (mm-Hg) unit or the kilopascal (kPa) unit, as required. Touch to access notification message information. A drop-down list of one or more messages will appear. Touch the FORWARD button or the BACK button to scroll through the notification messages as required. From the PREFERENCES button, select the setting option available, including the DOCKING button, the FILTER button, the LANGUAGES button, the MANIFOLD button, or the SUCTION UNITS button. Touch to reset the hours of use to zero after installing a new fluid suction HEPA filter. ALWAYS reset the hours of use after the installation of a new filter. 700000969828 Rev-AA 25 EN Docking1FilterkPALanguagesManifold LightManifoldmm-Hg1PreferencesReset HoursDRAFT NOT FOR SALE BBUUTTTTOONN NNAAMMEE FFUUNNCCTTIIOONN RESET HOURS CONFIRMATION RESET VOLUME RESET VOLUME CONFIRMATION RETURN SET AS DEFAULT OFF

(DOCKING) SETTINGS SOUND (SETTINGS) SPECIMEN LIGHT

(BRIGHTNESS) Touch to apply reset selection. Touch to access the RESET VOLUME dialog and reset the canister fluid volume value to zero. Touch to apply reset selection. Touch to exit a dialog and return to a previous dialog menu. From the DOCKING dialog menu, touch the SET AS DEFAULT button to enable or disable the default cycle to be performed when the rover is connected to the docker. The NORMAL WASH cycle or the EXTENDED WASH cycle may be selected as the DEFAULT. Touch to access the SETTINGS dialog menu. Select and adjust the system settings, as required, including BRIGHTNESS, SOUND, AND PREFERENCES. See To AdjusttheSettings (page 34). 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 volume or loudness of the audible indicator. See Audible Event Indicators. From the BRIGHTNESS dialog menu, touch the SPECIMEN LIGHT button. Touch the UP and DOWN arrows to increase or decrease the brightness. SPECIMEN LIGHT

(CONTROL) Touch to turn ON or OFF the light that illuminates the contents of the specimen collection manifold. START SUCTION Touch to start fluid suction. STOP SUCTION Touch to stop fluid suction. SURFACE LIGHT

(BRIGHTNESS) From the BRIGHTNESS dialog menu, touch the SURFACE LIGHT button. Touch the UP and DOWN arrows to increase or decrease the brightness. SURFACE LIGHT

(CONTROL) Touch to turn ON or OFF the light provided for the work surface. EN 26 700000969828 Rev-AA Reset HoursReset VolumeReset VolumeSet as DefaultSoundSpecimen LightSpecimen LightStart SuctionStop SuctionSurface LightSurface LightDRAFT NOT FOR SALE BBUUTTTTOONN NNAAMMEE FFUUNNCCTTIIOONN SUCTION UNITS

(PREFERENCES)

(international models of the rover only) The SUCTION UNITS button will appear disabled for US customers. UP/INCREASE Touch and hold to scroll up a list of options or increase a setting value. TTaabbllee 55 SSeeccoonnddaarryy CCoonnttrrooll PPaanneell BBuuttttoonnss BBUUTTTTOONN NNAAMMEE FFUUNNCCTTIIOONN ABORT EXTENDED WASH NORMAL WASH QUICK WASH RELEASE Touch to abort a wash or extended wash cycle while the time remaining in the cycle is greater than or equal to three (3) minutes. When selected, a quick drain cycle will occur. Touch to drain the contents of the canister, apply detergent to the interior walls of the canister, and rinse the detergent with water. Intermittent periods of soaking occur during the cycle. Touch to drain the contents of the canister, apply detergent to the interior walls of the canister, and rinse the detergent with water. More rinse cycles occur. Touch to drain the contents of the canister, apply detergent to the interior walls of the canister, and rinse the detergent with water. Fewer rinse cycles occur. Touch to disengage and release the rover from the docker after completion of a wash cycle. TTaabbllee 66 MMaaiinn CCoonnttrrooll PPaanneell DDiissppllaayy SSyymmbboollss SSYYMMBBOOLL DDEEFFIINNIITTIIOONN Adjust Brightness (menu dialog) Audible Indicator Loudness (menu dialog) Fluid Level Gauge with two liter increment marks/values. See Fluid Level Gauge/Indicator Colors. Manifold. See Manifold Symbol Screen Colors. 700000969828 Rev-AA 27 EN Suction UnitsDRAFT NOT FOR SALE TTaabbllee 77 SSeeccoonnddaarryy CCoonnttrrooll PPaanneell DDiissppllaayy SSyymmbboollss SSYYMMBBOOLL DDEEFFIINNIITTIIOONN Almost Full Fluid Level Gauge Indicator Full Fluid Level Guage Indicator Wash Cycle Complete Wash Cycle Error TTaabbllee 88 RRoovveerr SSyymmbboollss SSYYMMBBOOLL DDEEFFIINNIITTIIOONN Off Power Switch On Power Switch Eject Manifold Button Lock Filter Cover Unlock Filter Cover Align Lock/Unlock TTaabbllee 99 HHEEPPAA FFiilltteerr SSyymmbbooll SSYYMMBBOOLL DDEEFFIINNIITTIIOONN Replace this filter every six (6) months or as indicated by the rover. TTaabbllee 1100 MMaanniiffoolldd SSyymmbboollss SSYYMMBBOOLL DDEEFFIINNIITTIIOONN Align Lock/Unlock Lock Unlock EN 28 700000969828 Rev-AA 213465DRAFT NOT FOR SALE TTaabbllee 1111 LLaabbeelliinngg SSyymmbboollss SSYYMMBBOOLL DDEEFFIINNIITTIIOONN Refer to the Instruction Manual/Booklet (blue); ISO 7010M002 General Warning Sign (yellow); ISO 7010W001 TTaabbllee 1122 SSuuccttiioonn LLiimmiitt RRaannggeess aanndd CCoolloorrss CCOOLLOORR SSUUCCTTIIOONN LLIIMMIITT RRAANNGGEE VVAALLUUEE ((mmmm--HHgg)) IINNCCRREEMMEENNTT ((mmmm--HHgg)) MAXimum (orange) HIGH (orange) MEDium (yellow) LOW (green) OFF(white) 520 120 to 520 80 to 115 50 to 75 0 Not applicable 20 5 5 Not applicable TTaabbllee 1133 SSccrreeeenn TTiittllee AArreeaa CCoolloorrss CCOOLLOORR DDEEFFIINNIITTIIOONN Indicates SET UP SYSTEM or SUCTION OFF (gray) Indicates SUCTION ON (green) Indicates WARNING (orange) TTaabbllee 1144 BBuuttttoonn oorr OOppttiioonn CCoolloorrss CCOOLLOORR DDEEFFIINNIITTIIOONN Indicates CONFIRM, START SUCTION, or SELECTED (green) Indicates STOP SUCTION (red) TTaabbllee 1155 MMaanniiffoolldd SSyymmbbooll SSccrreeeenn CCoolloorrss CCOOLLOORR DDEEFFIINNIITTIIOONN Indicates USED manifold (pink) Indicates NEW manifold (white) TTaabbllee 1166 FFlluuiidd LLeevveell GGaauuggee//IInnddiiccaattoorr CCoolloorrss CCOOLLOORR DDEEFFIINNIITTIIOONN Indicates canister fluid volume is ALMOST FULL (blue) Indicates the previous procedure fluid volume captured after RESET selected (gray crosshatch) 700000969828 Rev-AA 29 EN DRAFT NOT FOR SALE CCOOLLOORR DDEEFFIINNIITTIIOONN Indicates the current procedure fluid volume captured after RESET selected (white) Indicates canister fluid volume is FULL (yellow) TTaabbllee 1177 MMeessssaaggee AArreeaa CCoolloorrss CCOOLLOORR DDEEFFIINNIITTIIOONN Indicates NOTIFICATION message (blue) Indicates ERROR message (yellow) TTaabbllee 1188 AAuuddiibbllee EEvveenntt IInnddiiccaattoorrss EEVVEENNTT IINNDDIICCAATTIIOONN TTRRIIGGGGEERR Button Touch Error Initial Startup Notification Click tone Main control panel display and secondary control panel display button actuation Three slow tones, three times Any error message Chime tone Startup screen with progress bar Two declining tones Any notification message Task Complete (confirmation) Ding tone Valid manifold installed successfully TTaabbllee 1199 AAbbbbrreevviiaattiioonnss aanndd AAccrroonnyymmss NNAAMMEE DDEEFFIINNIITTIIOONN HEPA High Efficiency Particulate Air Infrared wavelength light AC CA DC IR kPA L MAX MED MIN mL ML Alternating Current Canadian Direct Current Kilopascal Liter Maximum Medium Minimum or Minutes Milliliter Multilanguage mm-Hg Millimeter of mercury OR Operating Room EN 30 700000969828 Rev-AA DRAFT NOT FOR SALE 33.. GGeettttiinngg SSttaarrtteedd 33..11.. TToo UUnnppaacckk tthhee RRoovveerr WWAARRNNIINNGG -- LLIIFFTT HHAAZZAARRDD:: Always have more than one person unpack and remove this equipment from the shipping pallet. See Specifications (page 66) for rover weight. Failure to comply may result in personal injury. WWAARRNNIINNGG -- Upon initial receipt and before each use, inspect each component for damage. Do not use the product if damage is apparent. CCAAUUTTIIOONN -- Always save the original packaging container for reuse. Failure to comply may result in damage during transport to the Stryker customer service center. See Service (page 65). 1. Remove the exterior packaging material from the rover. Recycle the material as required. 2. Using at least two people, remove the rover from the shipping pallet. 3. Make sure all of the components are supplied with the rover. Some components may vary based on market requirements. See Components Supplied with the Rover 4. Inspect the rover and component for damage. If any of the components are missing or damaged, do not use the equipment. See ContactInformation (page 4) TTaabbllee 2200 CCoommppoonneennttss SSuupppplliieedd wwiitthh tthhee RRoovveerr DDeessccrriippttiioonn Symbol Definition Chart Neptune S Rover Instructions for Use (IFU) Neptune S Docking Station Instructional Poster Neptune S Quick Reference Card Neptune S Software Disclosure Power Cord1 PPaarrtt NNuummbbeerr 0036-716-000 700000969828 700000995644 700000995352 700001005331 0996-851-010 1For power cord options that meet country-specific requirements and are acceptable for use with the rover, see Power CordSpecifications (page 68) (country-specific). 33..22.. TToo AAdddd CCaanniisstteerr PPrreeffiillll FFlluuiidd Before the rover may be tested and placed into use, initial docking is required. Initial docking will add prefill fluid to the canister. See ToDocktheRover (page 54). Failure to comply will result in prefill errors and prevent the rover from operating properly. See Glossary (page 74) for definition of prefill fluid. 700000969828 Rev-AA 31 EN DRAFT NOT FOR SALE 33..33.. TToo TTeesstt tthhee RRoovveerr 33..33..11.. TToo CCoonnnneecctt PPoowweerr NNoottee -- Before first use, initial docking is required. Initial docking will add prefill fluid to the canister. See ToDockthe Rover (page 54). Failure to comply will result in prefill errors and prevent the rover from operating properly. See Glossary

(page 74) for definition of prefill fluid. 1. Connect 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 power cord plug has a latched release button to prevent unintended removal from the rover power receptacle. FFiigguurree 1166 TToo CCoonnnneecctt PPoowweerr 2. Push the power switch to the ON position. understanding. 3. To ensure safe use of the rover, read the safety warnings on the screen. Touch the CONFIRM button to acknowledge EN 32 700000969828 Rev-AA DRAFT NOT FOR SALE 33..33..22.. TToo TTeesstt SSuuccttiioonn NNoottee -- A SET UP SYSTEM screen will appear () after confirmation of the safety information. A valid manifold must be inserted into the manifold receptacle to enable suction control. 1. Obtain a new manifold and remove the manifold from its packaging. 2. Insert the new (valid) manifold into the manifold receptacle. Confirm on screen that the manifold is new and unused. NNoottee -- If the manifold is valid and inserted correctly, a SYSTEM READY indication will occur, a manifold indicator will 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 sure all the inlet ports of the manifold are closed. 4. Touch the START SUCTION button (Figure 17). FFiigguurree 1177 TToo SSttaarrtt aanndd AAddjjuusstt SSuuccttiioonn 5. Adjust the manual suction control dial to the maximum suction level. 6. Verify the actual suction value changes as indicated on the main control panel display and reaches a suction level of at least 494 mm-Hg. If not, see Troubleshooting (page 58). 7. Discard the manifold used for testing purposes. 700000969828 Rev-AA 33 EN DRAFT NOT FOR SALE 33..44.. TToo AAddjjuusstt tthhee SSeettttiinnggss NNoottee -- Make sure the rover has been initially prefilled, tested, and powered up. NNoottee -- See Figure 9. 1. From the main control panel display, touch the SETTINGS button. The SETTINGS dialog menu will appear (Figure 18). 2. From the SETTINGS dialog menu, touch the desired SETTINGS button, which includes BRIGHTNESS, SOUND, or PREFERENCES. PREFERENCES include DOCKING, FILTER, LANGUAGES, MANIFOLD, and SUCTION UNITS. IILLLLUUMMIINNAATTIIOONN Display Screen Canister Light Manifold Light Specimen Light Surface Light LLOOUUDDNNEESSSS Audible Indicator PPRREEFFEERREENNCCEESS OOppttiioonnss FFiigguurree 1188 SSeettttiinnggss MMeennuu DDiiaalloogg TTaabbllee 2211 BBrriigghhttnneessss OOppttiioonnss OOPPTTIIOONNSS Increase/Decrease TTaabbllee 2222 SSoouunndd OOppttiioonnss OOPPTTIIOONNSS Increase/Decrease TTaabbllee 2233 DDoocckkiinngg OOppttiioonnss DDOOCCKKIINNGG Quick Wash (two minutes) Normal Wash (five minutes) Extended Wash (forty five minutes) OOPPTTIIOONNSS Default Cycle Set as Default Set as Default EN 34 700000969828 Rev-AA DRAFT NOT FOR SALE FFIILLTTEERR 500 Hours LLAANNGGUUAAGGEESS Chinese (ZH) Danish (DA) Dutch (NL) English (EN) Finnish (FI) French (FR) German (DE) Italian (IT) Japanese (JA) Korean (KO) Norwegian (NO) Polish (PL) Portuguese (PT) Spanish (ES) Swedish (SV) TTaabbllee 2244 FFiilltteerr OOppttiioonnss OOPPTTIIOONNSS Reset Hours TTaabbllee 2255 LLaanngguuaaggee OOppttiioonnss OOPPTTIIOONNSS Dansk Nederlands English (Default) Suomi Franais Deutsch Italiano Norsk Polskie Portugus Espaol Svenska OOPPTTIIOONNSS mm-Hg kPA TTaabbllee 2266 SSuuccttiioonn UUnniitt OOppttiioonnss SSUUCCTTIIOONN UUNNIITTSS Millimeters of Mercury (United States) Kilopascal (International) 3. From the selected SETTINGS dialog menu, touch the desired setting option. Make the appropriate adjustment or selection as required. 4. Touch the CLOSE button or CONFIRM button to accept the adjustment or selection and exit. Touch the BACK button to cancel any adjustment or selection and exit. 5. After adjusting and/or selecting options, push power switch to OFF, disconnect the rover from facility power, and wrap the power cord around the power cord bracket. The rover is now ready for use. 700000969828 Rev-AA 35 EN DRAFT NOT FOR SALE 44.. UUssiinngg YYoouurr PPrroodduucctt 44..11.. TToo SSeettuupp tthhee RRoovveerr 44..11..11.. TToo CCoonnnneecctt PPoowweerr can be clearly seen. or healthcare staff injury. WWAARRNNIINNGG -- Do not use the rover until it is tested properly to ensure functionality. See ToTesttheRover (page 32). WWAARRNNIINNGG -- Do not cover the main control panel display with drapes or other objects. Always make sure the display WWAARRNNIINNGG -- Do not place the rover within the sterile field. Failure to comply may cause infection and result in patient CCAAUUTTIIOONN -- Always use the correct power cord configuration. Configurations will vary based on local requirements. See ForUseWith (page 12). See PowerCordSpecifications (page 68). NNoottee -- Do not use the rover until the docker is installed and tested properly to ensure functionality. See Documentation

(page 13) and the instructions for use supplied with the docker. NNoottee -- 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. Foam does not affect this fluid level value. See Specifications (page 66). 1. Position the rover on a flat surface and in a convenient location in the procedure room. 2. Lock the rovers casters to prevent unintended rover movement (Figure 19). FFiigguurree 1199 TToo PPrreeppaarree tthhee RRoovveerr 3. Orient the rover for optimal viewing of the main control panel display. Make sure the liquid level and canister contents may be clearly seen. Turn on the canister light at any time to view the contents of the canister. 4. Connect the rover to a hospital-grade electrical wall outlet using the supplied power cord. 5. Push the power switch to the ON position. 6. Read and acknowledge the warning messages on the main control panel display. Touch the ACKNOWLEDGE button to confirm understanding and access the on-screen controls. A SET UP SYSTEM screen will appear. EN 36 700000969828 Rev-AA DRAFT NOT FOR SALE 7. See ToInstallDisposableComponents (page 37). 44..22.. TToo IInnssttaallll DDiissppoossaabbllee CCoommppoonneennttss WWAARRNNIINNGG -- The manifold is for single patient use only. Do not reuse, process, service, modify, or repackage a single use device. apparent. The single-use device may not withstand chemical, chemical vapor, or high temperature sterilization processing. Design features may make cleaning difficult. Reuse may create a contamination risk and compromise structural integrity, resulting in operational failure during use. Failure to comply may lead to infection or cross-infection and result in patient and/or healthcare staff injury. WWAARRNNIINNGG -- Before use, inspect each disposable component for damage. Do not use any equipment if damage is WWAARRNNIINNGG -- Do not use a manifold that has been dropped or mishandled. Failure to comply may cause leakage and result in patient and/or healthcare staff injury. FFiigguurree 2200 DDoo NNoott DDrroopp tthhee MMaanniiffoolldd WWAARRNNIINNGG -- Do not remove the suction tubing from the manifold ports during use and at shutdown. Always leave the suction tubing attached to the manifold ports after installation. WWAARRNNIINNGG -- Do not use a Y-connector to add more than one suction line to each port. Failure to comply may cause cross-contamination and result in patient injury. FFiigguurree 2211 DDoo NNoott UUssee aa YY--ccoonnnneeccttoorr NNoottee -- If the collection of small specimens is required during the procedure, select a specimen collection manifold with a collection tray. Obtain additional specimen collection trays for use, if necessary. See ForUseWith (page 12). NNoottee -- If specimen collection is not required during the procedure, select the disposable 4-port manifold. 700000969828 Rev-AA 37 EN DRAFT NOT FOR SALE 1. Select the appropriate manifold for the procedure. See ForUseWith (page 12). WWAARRNNIINNGG -- Always install a new, non-sterile, single patient use manifold before each procedure. 2. Align the manifold tabs and insert the manifold into the manifold receptacle. Push the manifold straight into the receptacle until a click is heard (Figure 22). Confirm the new manifold symbol (white) appears on the main control panel display and a confirmation sound occurs. FFiigguurree 2222 TToo IInnssttaallll aa MMaanniiffoolldd NNoottee -- If a used manifold is installed, a used manifold symbol (pink) appears and a notification sound occurs. WWAARRNNIINNGG -- Always install new, sterile, single use suction tubing to the manifold port(s) before each procedure. 3. Obtain new sterile suction tubing. See ForUseWith (page 12). 4. Connect the suction tubing to the appropriate manifold port(s). NNoottee -- 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 will decrease the vacuum level efficiency. FFiigguurree 2233 AAllwwaayyss CClloossee UUnnuusseedd MMaanniiffoolldd PPoorrttss NNoottee -- If using a specimen collection manifold, always connect the suction tubing to the top primary manifold port. The bottom auxillary port is used for secondary suction only. Make sure the auxillary port is closed when not in use. NNoottee -- If using a 4port manifold, connect the suction tubing to any available manifold port. Make sure any unused port

(s) are closed to prevent loss of suction. NNoottee -- If using an endoscope, connect the other end of the suction tubing to the suction connector on the endoscope NNoottee -- If using a suction end effector, connect the other end of the suction tubing to the fluid suction accessory. connector. EN 38 700000969828 Rev-AA DRAFT NOT FOR SALE NNoottee -- If the rover display indicates sufficient fluid volume capacity in the canister, the rover may be used for another surgical procedure before waste disposal. Adding fluid from a second procedure on top of the previous procedure is called fluid stacking. NNoottee -- Before each procedure, touch the RESET VOLUME button to reset the procedure 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 measurement reads anything other than zero milliliters, touch the RESET VOLUME button to reset the fluid volume value to zero, then select the confirm button (Figure 24). 6. See ToOperatetheRover (page 40). FFiigguurree 2244 TToo RReesseett FFlluuiidd VVoolluummee VVaalluuee 700000969828 Rev-AA 39 EN DRAFT NOT FOR SALE 44..33.. TToo OOppeerraattee tthhee RRoovveerr WWAARRNNIINNGG HHIIGGHH SSUUCCTTIIOONN HHAAZZAARRDD [[MMAAXX == 552200 mmmm--HHgg]]

The effectiveness of aspiration is dependent upon the intensity of the suction applied. Always use the minimum suction limit range required to achieve the desired clinical outcome. Always follow your local healthcare guidelines for suction limits. The suction limit range of the collection canister may be adjusted by using the manual suction control dial on the main control panel. Interruption and restoration of rover power while suction is ON, whether accidental or intentional, does not reset the suction limit range to zero. See BS EN ISO 10079-1: 2015 + A1: 2019, clause 9.11. Use caution when activating suction with a high suction limit range. Death or serious injury can result from the improper application of suction levels. WWAARRNNIINNGG IINNAAPPPPRROOPPRRIIAATTEE CCOONNNNEECCTTIIOONN HHAAZZAARRDD Do not connect directly to chest tubes. Do not connect to closed wound drains. Do not connect directly to tracheal tubes. Not 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 connections. WWAARRNNIINNGG -- Always operate the product within the specified environmental condition values. 44..33..11.. TToo MMaannaaggee FFlluuiidd SSuuccttiioonn WWAARRNNIINNGG FFLLUUIIDD WWAASSTTEE LLEEAAKKAAGGEE HHAAZZAARRDD Always make sure rover power is ON when collecting fluid waste. The rover can only detect a full canister if the rover power is ON. If rover power is OFF, fluid waste leakage can occur. WWAARRNNIINNGG -- The collection canister scale and main control panel display are not diagnostic tools. Do not use the scale or the display to determine the amount of fluid lost from or retained by the patient. NNoottee -- Make sure the rover has been properly prepared for operation. See ToSetuptheRover (page 36). NNoottee -- The rover provides an adjustable suction limit of 50 to 520 mm-Hg measured with all manifold inlet ports closed. NNoottee -- To reset the fluid level value to zero, touch the RESET VOLUME button on the main control panel display. The canister fluid level value will reset to a zero value. EN 40 700000969828 Rev-AA DRAFT NOT FOR SALE NNoottee -- See High Suction Visual and Audible Indicators for important condition, indication, and action information. TTaabbllee 2277 HHiigghh SSuuccttiioonn VViissuuaall aanndd AAuuddiibbllee IInnddiiccaattoorrss CCOONNDDIITTIIOONN IINNDDIICCAATTIIOONN AACCTTIIOONN HIGH suction limit RANGE The suction limit range selected is equal to or greater than 120 mm-Hg. Two declining tones; orange HIGH suction banner appears on the main control panel display; suction range indicator illuminates orange. Determine whether a high suction range is desired. 1. While viewing the main control panel display, turn the suction control dial to the level of suction required (Figure 25). 2. Touch the START SUCTION button to start fluid suction. NNoottee -- After suction has started, the STOP SUCTION button may be touched to stop fluid suction. FFiigguurree 2255 TToo SSttaarrtt aanndd AAddjjuusstt SSuuccttiioonn WWAARRNNIINNGG -- Always use the minimum suction limit required to achieve the desired clinical outcome. 3. Turn the suction control dial to adjust the suction limit during the procedure as required. 4. Adjust the location of the suction end effector at the surgical site as required. 5. Suction the fluid from the surgical site at various suction limit values or intervals as required. 6. If the specimen collection manifold is install for use during the surgical procedure, see ToCollectaSpecimen (page 43). 700000969828 Rev-AA 41 EN DRAFT NOT FOR SALE 44..33..22.. TToo MMaannaaggee FFlluuiidd CCaanniisstteerr VVoolluummee 1. Monitor the volume of fluid captured in the rover canister. See Fluid Volume Conditions and Indicators. TTaabbllee 2288 FFlluuiidd VVoolluummee CCoonnddiittiioonnss aanndd IInnddiiccaattoorrss CCOONNDDIITTIIOONN IINNDDIICCAATTIIOONN AACCTTIIOONN CCAANNIISSTTEERR AALLMMOOSSTT FFUULLLL The fluid volume level in the canister is approaching maximum capacity. Fluid suction will soon stop in the full canister. CCAANNIISSTTEERR FFUULLLL The fluid volume level is at maximum capacity. Fluid suction has stopped in the full canister. Two declining tones occur; a notification message appears on the main control panel display and an almost full fluid level gauge indicator appears on the secondary control panel display (Figure 26). Three slow tones occur continuously;

an error message and SUCTION STOPPED banner appear on the main control panel display. A general warning sign and full fluid level gauge indicator appear on the secondary control panel display (Figure 27). Prepare to switch to an alternate suction source. Prepare to switch to an alternate suction source. Dock the rover to dispose of waste. See ToDocktheRover (page 54). FFiigguurree 2266 AAllmmoosstt FFuullll CCaanniisstteerr DDiissppllaayy IInnddiiccaattiioonnss AA Main Control Panel Display BB Secondary Control Panel Display (located on rovers back side) EN 42 700000969828 Rev-AA CBADRAFT NOT FOR SALE FFiigguurree 2277 FFuullll CCaanniisstteerr DDiissppllaayy IInnddiiccaattiioonnss AA Main Control Panel Display BB Secondary Control Panel Display 2. If the 8-liter canister is full, shut down the rover. See ToShutDowntheRover (page 47). Dock the rover to empty the full canister. See ToDocktheRover (page 54). 44..44.. TToo CCoolllleecctt aa SSppeecciimmeenn 44..44..11.. TToo UUssee tthhee SSppeecciimmeenn CCoolllleeccttiioonn TTrraayy NNoottee -- Make sure the specimen collection manifold is installed in the rover and connected properly. See ToInstall DisposableComponents (page 37). NNoottee -- If using a specimen collection manifold, make sure the suction tubing is connected to the top primary manifold port. The bottom auxillary port is used for secondary suction only. Make sure the auxillary port is closed when not in use. 1. To illuminate the specimen collection tray where the specimen will be collected, touch the SPECIMEN LIGHT button on the main control panel display.(Figure 28). 2. To illuminate the work surface where the specimen will be transferred, touch the SURFACE LIGHT button on the main FFiigguurree 2288 TTuurrnn oonn LLiigghhttss control panel display. 700000969828 Rev-AA 43 EN CBADRAFT NOT FOR SALE 3. Remove a small specimen collection tray from its packaging. 4. Open the collection tray port door of the specimen collection manifold. 5. Insert the collection tray into the specimen collection manifold. 6. Suction fluid waste and specimen (polyp) material from the surgical site as required. 7. Examine the contents of the illuminated specimen collection manifold tray. NNoottee -- Collected specimens can be observed by looking through the top viewing window on the specimen collection manifold. 8. After a specimen is collected and transfer of the specimen is appropriate, remove the collection tray from the manifold by pinching the tabs of the tray together and pulling the collection tray away from the manifold (Figure 29). FFiigguurree 2299 RReemmoovvee SSppeecciimmeenn CCoolllleeccttiioonn TTrraayy NNoottee -- To maintain suction after removing the collection tray, insert another collection tray into the specimen collection manifold immediately or close the collection tray port door of the specimen collection manifold. Suction does not need to be turned off when inserting or removing a specimen collection tray. 9. Transfer the specimen into the appropriate container using the illuminated work surface on top of the rover. NNoottee -- The specimen collection tray may again be installed in the specimen collection manifold during the same procedure. Close the collection tray port using the cap if the specimen collection tray is not used. 10. After the procedure, perform ToShutDowntheRover (page 47). EN 44 700000969828 Rev-AA DRAFT NOT FOR SALE 44..44..22.. TToo UUssee tthhee SSeeccoonnddaarryy SSppeecciimmeenn CCoolllleeccttiioonn BBaasskkeett NNoottee -- The specimen collection manifold contains a secondary specimen collection basket as a back-up method to collect specimens in the event that a specimen collection tray was not inserted in the manifold while suctioning the specimen material. NNoottee -- The secondary specimen collection basket is not intended to be used as a primary means 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). Disconnect the suction tubing from the manifold port. 2. Push the EJECT button to release the specimen collection manifold from the rover receptacle (Figure 31). FFiigguurree 3300 SSttoopp tthhee SSuuccttiioonn 3. Remove the manifold from the rover. (Figure 32) FFiigguurree 3311 EEjjeecctt tthhee MMaanniiffoolldd FFiigguurree 3322 RReemmoovvee tthhee MMaanniiffoolldd 700000969828 Rev-AA 45 EN Stop SuctionDRAFT NOT FOR SALE WWAARRNNIINNGG -- To avoid exposure to potentially infectious fluid, make sure the manifold is held in a vertical position when removing the front housing cap to gain access to the secondary collection basket. 4. Holding the manifold in a vertical orientation, twist the front housing cap of the manifold counterclockwise to open the manifold and access the secondary collection basket (Figure 33). 5. Transfer the specimen from the secondary collection basket inside the manifold into an appropriate container located on FFiigguurree 3333 AAcccceessss SSeeccoonnddaarryy CCoolllleeccttiioonn BBaasskkeett NNoottee -- If suction is required immediately, a new manifold may be installed into the rover directly after removing the first the work surface of the rover. manifold. transferring the specimen. NNoottee -- If suction is not required immediately, the manifold may be reassembled and inserted into the rover after 6. To reassemble the manifold, align the tabs and keyed slots of the two halves of the manifold and then twist clockwise until the two halves are locked in place (Figure 34). 7. Follow the proper procedures to insert the specimen collection manifold into the rover, connect the suction tubing to the manifold port, and select a suction limit before resuming suction. FFiigguurree 3344 RReeaasssseemmbbllee tthhee MMaanniiffoolldd EN 46 700000969828 Rev-AA DRAFT NOT FOR SALE 44..55.. TToo SShhuutt DDoowwnn tthhee RRoovveerr 44..55..11.. TToo RReemmoovvee DDiissppoossaabbllee CCoommppoonneennttss WWAARRNNIINNGG Always follow local regulations regarding proper handling and disposal of biohazard waste. Failure to comply may cause infection and result in healthcare staff injury. NNoottee -- Although the disposable, single-use manifold(s), suction tubing, and suction accessories must be replaced between patients, it may not be necessary to empty the rover collection canister. NNoottee -- 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 manifold port to purge the tubing of fluid waste. Do not remove any attached suction tubing from the manifold. 2. Touch the STOP SUCTION button on the main control panel display to stop fluid suction (Figure 35). 3. Push the EJECT button to remove the manifold from the receptacle (Figure 36). Maintain the manifold in a horizontal orientation. FFiigguurree 3355 SSttoopp tthhee SSuuccttiioonn FFiigguurree 3366 RReemmoovvee tthhee MMaanniiffoolldd 700000969828 Rev-AA 47 EN Stop SuctionDRAFT NOT FOR SALE 4. Pull the manifold with the attached suction tubing out of the receptacle to fully remove the manifold from the rover.

(Figure 37). 5. Maintaining the manifold in a horizontal orientation, properly dispose of the used manifold and attached suction tubing. FFiigguurree 3377 GGaatthheerr tthhee SSuuccttiioonn CCoommppoonneennttss EN 48 700000969828 Rev-AA DRAFT NOT FOR SALE 44..55..22.. TToo RReemmoovvee PPoowweerr aanndd RReellooccaattee tthhee RRoovveerr NNoottee -- Always use the rover handle when repositioning or relocating the rover. NNoottee -- If the rover is full or the rover will not be used for two hours, dock the rover to dispose of the collected fluid waste in the canister. NNoottee -- The rover is not required to be connected to facility power when not in use. 1. Push the power switch to the OFF position (Figure 38). 2. Disconnect the power cord from facility electrical power. Wrap the power cord around the cord bracket. 3. Unlock the casters of the rover. Make sure all four casters are unlocked. FFiigguurree 3388 RReemmoovvee tthhee PPoowweerr 4. 5. If the canister is full or the rover contains fluid waste and will not be used within two hours, relocate the rover to the docker using the rover handle. See ToDocktheRover (page 54). If the canister is not full and the rover will be used within two hours, relocate the rover to the desired location using the rover handle. See ToSetuptheRover (page 36). 6. Clean and disinfect the rover after every surgical procedure. See ToCleanandDisinfecttheRover (page 50). 700000969828 Rev-AA 49 EN DRAFT NOT FOR SALE 55.. AAfftteerr UUssee 55..11.. TToo CClleeaann aanndd DDiissiinnffeecctt tthhee RRoovveerr WWAARRNNIINNGG -- Always clean and disinfect the rover upon initial receipt and before each use. Failure to comply may cause infection and result in patient or healthcare staff injury. CCAAUUTTIIOONN -- Do not immerse any system component in liquid. Do not allow liquids or moisture to enter any electrical connection. CCAAUUTTIIOONN -- Do not sterilize any system component. CCAAUUTTIIOONN -- Do not use solvents, lubricants, or other chemicals, including glutaraldehyde or similar chemical cleaners, unless otherwise specified. See Glossary (page 74). CCAAUUTTIIOONN -- Do not use unapproved disinfectants. Failure to comply may cause system damage. RReeccoommmmeennddeedd EEqquuiippmmeenntt aanndd MMaatteerriiaallss PPE as recommended by the disinfectant supplier Soft, lint-free cloth United States Environmental Protection Agency (US EPA) registered disinfectant with a claim for activity against 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 Cleaner with Bleach (EPA Reg. #67619-17), Quaternary Ammonium Based - CaviCide (EPA Reg. #46781-6) 55..11..11.. TToo WWiippee DDoowwnn tthhee RRoovveerr 1. Wipe all external surfaces of the rover with a soft, lint-free cloth moistened with a non-abrasive, hospital disinfectant prepared to the manufacturers instructions. Pay particular attention to highlighted critical areas such as the work surface, handle, main control panel, communication window, and manifold receptacles (Figure 39). FFiigguurree 3399 WWiippee DDoowwnn tthhee RRoovveerr 2. Upon the removal of visible, gross soil, use a clean cloth moistened with disinfectant and wipe all surfaces. Surfaces must remain visibly wet at room temperature for at least the minimum time specified in the instructions for use supplied by disinfectant manufacturer. 3. Remove any excess disinfectant solution using a soft, lint-free cloth moistened with water if required by the instructions supplied by the disinfectant manufacturer. EN 50 700000969828 Rev-AA DRAFT NOT FOR SALE 4. Inspect the rover. See ToInspecttheEquipment (page 51). 5. Refill the manifold holder with new, unused manifolds, as required. See ForUseWith (page 12) for ordering information. 6. If the rover will be used again, use the rover handle to push and relocate the rover. See ToSetuptheRover (page 36). If the rover will no longer be used, use the rover handle to push and relocate the rover to a storage area. See Storageand Handling (page 58). 55..22.. TToo IInnssppeecctt tthhee EEqquuiippmmeenntt NNoottee -- Only biomedical equipment technicians trained and experienced in the maintenance of this reusable medical device should inspect and maintain this equipment. WWAARRNNIINNGG -- Upon initial receipt and before each use, inspect each component for damage. Do not use the product if damage is apparent. WWAARRNNIINNGG -- Always comply with the inspection interval to ensure the safe and effective use of the equipment. WWAARRNNIINNGG -- Do not disassemble, modify, or repair this product without the authorization of the manufacturer. Contact Stryker for service. NNoottee -- For service, contact your Stryker sales representative or call service. See ContactInformation (page 4). Outside the US, contact your nearest Stryker subsidiary. NNoottee -- Maintenance documentation for this equipment is available upon request to Stryker-authorized service personnel only. NNoottee -- Routine and careful inspection of the equipment is the best method for determining the service life of the equipment. See Inspection Criteria and Actions. IInntteerrvvaall Before initial use TTaabbllee 2299 IInnssppeeccttiioonn CCrriitteerriiaa aanndd AAccttiioonnss CCrriitteerriiaa AAccttiioonn Inspect the equipment for damage or missing components. If damage is apparent, replace the equipment. See ForUseWith (page 12) section. Make sure the rover and docker operate properly. See ToDocktheRover (page 54) and To TesttheRover (page 32). Before each use and after each cleaning and disinfection. Inspect the equipment for damage or missing components. If damage is apparent, replace the equipment. See ForUseWith (page 12). Inspect the equipment for corrosion, discoloration, pitting, cracked materials, or unacceptable deterioration on any external surfaces, including labels and product markings. Inspect the canister exterior, smoke evacuator filter cover, and infrared communication window for cracks or damage. Inspect the caster and make sure the locks function properly. Inspect the power cord for cuts and the power cord plug for bent pins. 700000969828 Rev-AA 51 EN DRAFT NOT FOR SALE IInntteerrvvaall CCrriitteerriiaa AAccttiioonn Inspect the power cord receptacle for bent pins or bent contacts. Inspect the infrared communication window for any dirt or debris. Six months Inspect the replacement date on the label of the fluid suction HEPA filter. The fluid suction filter life is 500 hours. Thoroughly remove any dirt or debris on the infrared communication window. See ToCleanandDisinfecttheRover (page 50). Replace the fluid suction HEPA filter every six months or as indicated on the main control panel display. See ForUse With (page 12) and ToReplacetheHEPA Filter (page 52). NNoottee -- If any component must be discarded, see Disposal/Recycle (page 65). 55..33.. TToo RReeppllaaccee tthhee HHEEPPAA FFiilltteerr Failure to comply may cause infection and result in healthcare staff injury. WWAARRNNIINNGG -- Do not touch the filter media. The media filters the air evacuated from fluid collection canister of the rover before the air is vented. Failure to comply may cause media damage and result in patient and/or healthcare staff injury. FFiigguurree 4400 PPrreevveenntt DDaammaaggee ttoo FFiilltteerr MMeeddiiaa EN 52 700000969828 Rev-AA DRAFT NOT FOR SALE 55..33..11.. TToo IInnssttaallll tthhee FFlluuiidd SSuuccttiioonn HHEEPPAA FFiilltteerr NNoottee -- Replace the filter REF 0702-034-000 every six months or as indicated on the control panel display of the rover. Failure to comply will result in the reduction of fluid suction or an increase in odor. NNoottee -- The filter life is 500 hours. The rover calculates filter usage time automatically. Always reset the filter timer after the filter is replaced. 1. Make sure the rover power switch is OFF. 2. Turn the filter cover counterclockwise and align the arrow to unlock the filter cover. Remove the filter cover (Figure 41). Install the filter cover over the filter compartment; turn the filter cover clockwise to align the arrow in the lock position. FFiigguurree 4411 RReemmoovvee aanndd RReeppllaaccee tthhee FFiilltteerr 3. Remove and properly dispose of the used HEPA filter. 4. Obtain a new HEPA filter. See ForUseWith (page 12). 5. Mark the replacement date on the label of the new HEPA filter. Install the new HEPA filter into the filter compartment. 6. 7. 55..33..22.. TToo VVeerriiffyy PPrrooppeerr FFiilltteerr IInnssttaallllaattiioonn 1. Connect the rover power cord to facility power. 2. Press the rover power switch to the ON position. CONFIRM on the control panel. 4. Insert a manifold into the manifold receptacle. 3. Read the safety information on the control panel display. Based on the configuration of the rover, select OK or 5. Turn on suction and adjust the canister to the maximum suction level. Make sure the maximum suction level is obtained. NNoottee -- If the maximum suction level is NOT reached, reposition the filter. If the suction level is still NOT reached, contact service. 55..33..33.. TToo RReesseett tthhee FFiilltteerr TTiimmeerr 1. Access the SETTINGS menu. Select the PREFERENCES dialog and the FILTER button (Figure 9). 2. Touch the FILTER button to access the FILTER dialog and RESET HOURS button. Touch the button to reset the hours to zero; close the dialog. 700000969828 Rev-AA 53 EN DRAFT NOT FOR SALE 55..44.. TToo DDoocckk tthhee RRoovveerr docker during the docking procedure. WWAARRNNIINNGG -- PPIINNCCHH PPOOIINNTT HHAAZZAARRDD Always keep hands out and away from the mating surfaces of the rover and NNoottee -- If the rover is full or the rover will not be used for two hours, dock the rover to dispose of the collected fluid waste in the canister. docker. NNoottee -- Use the docker to empty the rover canister of fluid waste and perform a wash cycle. Prefill fluid will remain 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 cycle, the rover is ready for use or storage. NNoottee -- Before docking the rover, always allow the docker to initiate for at least 60 seconds after applying power to the NNoottee -- The docker provides power to the rover during the docking process. NNoottee -- For optimal cleaning of the rover canister, use a water temperature of 37.8 to 43.3 C [100 to 110 F]. NNoottee -- Do not lock the rover casters while the rover is connected to the docker. EN 54 700000969828 Rev-AA DRAFT NOT FOR SALE 55..44..11.. TToo PPrreeppaarree tthhee DDoocckkeerr 1. Make sure the docker power switch is in the ON position and illuminated (Figure 42). 2. Make sure the bottle of Neptune Docking Detergent REF 0700-001-026 is connected to the docker. NNoottee -- 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 bottle contains enough detergent to perform a wash cycle. See ForUseWith (page 12) section. FFiigguurree 4422 PPrreeppaarree tthhee DDoocckkeerr 700000969828 Rev-AA 55 EN DRAFT NOT FOR SALE 55..44..22.. TToo PPeerrffoorrmm WWaasshh CCyyccllee 1. Push the rover toward the docker and between the docker guides until the rover and docker engage automatically

(Figure 43). Make sure the strike plates of the rover engage with the electromagnets of the docker. Do not lock the casters. 2. Press one of three timed wash cycle buttons from the secondary control panel display (Figure 44). See Wash Cycle FFiigguurree 4433 DDoocckk tthhee RRoovveerr Options. BBUUTT--

TTOONN FFiigguurree 4444 SSeeccoonnddaarryy CCoonnttrrooll PPaanneell IInniittiiaall DDoocckkiinngg TTaabbllee 3300 WWaasshh CCyyccllee OOppttiioonnss CCYYCCLLEESS DDEESSCCRRIIPPTTIIOONN TTIIMMEE ((AAPPPPRROOXXIIMMAATTEE)) Quick Wash Cycle drains the contents of the canister, 2 minutes Normal Wash

(default) Extended Wash applies detergent to the interior walls of the canister, and rinses the detergent with water. Fewer rinse cycles occur. Used to get the rover back into service as quickly as possible. Cycle drains the contents of the canister, applies detergent to the interior walls of the canister, and rinses the detergent with water. More rinse cycles occur. Used for normal everyday cleaning needs. Cycle drains the contents of the canister, applies detergent to the interior walls of the canister, and rinses the detergent with water. Intermittent periods of soaking occur during the cycle. Used when the canister is especially soiled. 5 minutes 45 minutes EN 56 700000969828 Rev-AA DRAFT NOT FOR SALE 3. If no option is selected, the default wash cycle will run (Figure 45). FFiigguurree 4455 SSeeccoonnddaarryy CCoonnttrrooll PPaanneell WWaasshh CCyyccllee BBeeggiinnss 4. During the wash cycle, the selected wash cycle counts down. The remaining time is shown on the display (Figure 46). NNoottee -- An Abort button may be selected to cancel a wash cycle if the cycle has not yet begun. If a 5 minute or 45 minute wash cycle has already begun, selecting the Abort button will divert the wash cycle to the shortest 2 minute wash cycle. FFiigguurree 4466 SSeeccoonnddaarryy CCoonnttrrooll PPaanneell DDiissppllaayy WWaasshh CCyyccllee CCoouunntt DDoowwnn 5. When the wash cycle is complete, press the Release button to disengage the rover from the docker (Figure 47). FFiigguurree 4477 SSeeccoonnddaarryy CCoonnttrrooll PPaanneell DDiissppllaayy WWaasshh CCyyccllee CCoommpplleettee NNoottee -- The green checkmark symbol indicates the wash cycle is complete. A yellow triangle symbol indicates a wash cycle error. 6. Pull the rover away from the docker. more thorough cleaning of the canister. 7. Visually inspect the canister for any remaining soil. If soil remains, an Extended Wash cycle is available to provide a 700000969828 Rev-AA 57 EN DRAFT NOT FOR SALE 66.. RReeffeerreenncceess 66..11.. SSttoorraaggee aanndd HHaannddlliinngg CCAAUUTTIIOONN -- Always store and transport the equipment within the specified environmental condition values throughout its useful life. See Specifications (page 66). CCAAUUTTIIOONN -- Always call service before transporting or storing this equipment in freezing conditions. See Contact Information (page 4). Failure to comply will cause the expansion of frozen internal fluid to damage the equipment. NNoottee -- The rover does not have to be connected to facility power when not in use. 66..22.. TTrroouubblleesshhoooottiinngg Stryker for service. WWAARRNNIINNGG -- Do not disassemble, modify, or repair this product without the authorization of the manufacturer. Contact NNoottee -- For service, contact your Stryker sales representative or call service. See ContactInformation (page 4). Outside the US, contact your nearest Stryker subsidiary. TTaabbllee 3311 RRoovveerr OOppeerraattiioonn OOBBSSEERRVVAATTIIOONN CCOORRRREECCTTIIVVEE AACCTTIIOONN The rover does not power up and the power switch is in the ON position. No vacuum pump action after the START SUCTION button is touched. Canister is full and an error occurs. Dock the rover. See To DocktheRover (page 54). The rover does not recognize a manifold. The rovers fluid suction is weak or insufficient. 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 or off. Make sure facility power is provided to the hospital-grade power receptacle. Manifold is altered or damaged. Replace the manifold. See ForUseWith (page 12). See ToInstallDisposable Components (page 37). The rover is damaged. Remove the rover from use. Contact service. See ContactInformation (page 4). Manifold is not installed correctly. Make sure the manifold is seated and locked in place. See ToInstallDisposable Components (page 37). Unused manifold ports are open. Close all unused inlet ports of the manifold installed in the 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 suction accessory. EN 58 700000969828 Rev-AA DRAFT NOT FOR SALE OOBBSSEERRVVAATTIIOONN CCOORRRREECCTTIIVVEE AACCTTIIOONN Suction tubing is too long or has a narrow diameter. Use shorter length or larger diameter suction tubing. See For UseWith (page 12). Manifold is clogged or damaged. Replace the manifold. See ForUseWith (page 12). The suction control dial is adjusted too low. Turn the suction control dial to adjust the suction limit to the proper level. See ToOperatetheRover (page 40). The fluid suction filter requires replacement. Replace the fluid suction filter. See ForUseWith (page 12). See To ReplacetheHEPAFilter (page 52). The rover is damaged. Remove the rover from use. Contact Stryker Neptune Customer Service. See Contact Information (page 4). An error (medium priority alert) has occurred. See TroubleshootingCodes (page 62). The rover is damaged. Remove the rover from use. Contact Stryker Neptune Customer Service. See Contact Information (page 4). The fluid suction filter has exceeded its useful life. Replace the HEPA fluid suction filter. See ForUseWith (page 12). See ToReplacetheHEPAFilter (page 52). The fluid suction filter has exceeded its useful life. Replace the fluid suction HEPA filter. See ForUseWith (page 12). See ToReplacetheHEPAFilter (page 52). The docker does not dispense detergent during the cleaning cycle. See Docking Station Operation and TroubleshootingCodes (page 62). The canister require special additional cleaning. Remove the rover from use. Contact service. See Contact Information (page 4). Electrical noise is present. Turn off all the electrical equipment not in use in the room. Relocate the electrical equipment to maximize the distance between the equipment. Increase spatial distance. Connect the electrical equipment into different hospital-

grade facility power receptacles with protective earth

(ground). The rovers suction capability is lost. A filter notification message appears on the main control panel display. The rover is releasing a strong odor. Sporadic electrical interference is experienced. NNoottee -- See the Neptune 2 Docking Station Instructions For Use REF 0702-014-700 and the Neptune S Docking Station Instructional Poster REF 700000995644 for additional troubleshooting information. 700000969828 Rev-AA 59 EN DRAFT NOT FOR SALE TTaabbllee 3322 DDoocckkiinngg SSttaattiioonn OOppeerraattiioonn OOBBSSEERRVVAATTIIOONN CCOORRRREECCTTIIVVEE AACCTTIIOONN The rover will not dock or an error has occurred during docking. The docker power cord is not connected or is loosely connected. Make sure the docker power cord is connected securely. See ToDocktheRover (page 54). The docker power switch is in the OFF position. Make sure the power switch is in the ON position and illuminated. If power switch is OFF, push the power switch to the ON position. Wait 60 seconds. Dock the rover. The docker power switch is in the ON position, but not illuminated. Make sure facility power is provided to the hospital-grade power receptacle. If facility power is OFF, apply facility power to the docker. Wait 60 seconds. Dock the rover. The rover is not completely connected to the docker. Push the rover forward enough to complete a docker-rover interface connection. See ToDocktheRover (page 54). Communication between the rover and docker is interrupted because the infrared communication window is either dirty or obstructed. Remove the dirt or debris from the rovers infrared communication window. See ToClean andDisinfecttheRover (page 50). Dock the rover. Remove any obstruction from the dockers infrared communication windows. Make sure there are no tubes, hoses, or towels covering the dockers infrared communication windows. Dock the rover. See ToDockthe Rover (page 54). 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 the docker. Wait 60 seconds. Dock the rover. If the problem persists, the docker may be damaged. Contact Stryker Neptune Customer Service. See Contact Information (page 4). The presence of prefill is normal. This water and detergent solution (prefill) initiates the breakdown of fluid waste collected during the rovers next use. No action is required. The end of the detergent inlet tube is not immersed in the detergent. Make sure the detergent inlet tube is routed through the tube stiffener and the end of the tube reaches the bottom of the detergent bottle. The detergent inlet tube is not connected securely to the detergent inlet port of the docker. Securely connect the detergent inlet tube to the detergent inlet port of the docker. Prefill fluid remains inside the rover canister after a cycle is complete. The docker does not dispense detergent during the cleaning cycle. The bottle of detergent is empty. Replace the bottle of detergent. See ForUseWith (page 12). EN 60 700000969828 Rev-AA DRAFT NOT FOR SALE OOBBSSEERRVVAATTIIOONN CCOORRRREECCTTIIVVEE AACCTTIIOONN The rover canister is not clean after a cleaning cycle. An error occurs while the rover is docked and the rover cannot be removed from the docker. The rover cannot be removed from docker. If the problem persists, the docker may be damaged. Contact Stryker Neptune Customer Service. See Contact Information (page 4). The water temperature supplied to the docker is not adjusted for optimal cleaning. For optimal cleaning of the canisters, use a water temperature of 37.8 to 43.3 C [100 to 110 F]. See the instructions for use supplied with the docker. The bottle of detergent is empty. Replace the bottle of the detergent. See ForUseWith (page 12)and the instructions for use supplied with the detergent. The fluid connectors 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 ContactInformation (page 4). The two rear casters are locked. Make sure the two rear casters are unlocked. Do not lock the casters when the rover is docked. Pull the rover away from the docker. The operator failed to acknowledge the docking cycle is complete. From the secondary control panel display, touch the ESCAPE button to disconnect the rover from the docker. 700000969828 Rev-AA 61 EN DRAFT NOT FOR SALE 66..33.. TTrroouubblleesshhoooottiinngg CCooddeess NNoottee -- A low priority (notification) or medium priority (error) alert message may appear on the main control panel display. Touch the indicator area to access the drop-down list and/or message. See Error Codes and Actions. NNoottee -- For service, contact your Stryker sales representative or call service. See ContactInformation (page 4). Outside the US, contact your nearest Stryker subsidiary. CCOODDEE 0.X 1.1 1.2 1.X 2.2 3.0 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.9 TTaabbllee 3333 EErrrroorr CCooddeess aanndd AAccttiioonnss MMEESSSSAAGGEE System Error PPRRIIOORRIITTYY Error (medium) Memory Error Notification (low) Memory Error Error (medium) IPC Failure Error (medium) Docker COM Error Coupling Error Error (medium) Offload Error Error (medium) Prefill Error Error (medium) Coupling Error Error (medium) AACCTTIIOONN Call service. See Contact Information (page 4). Setting options, including brightness, loudness, and the default docking cycle require resetting. See To AdjusttheSettings (page 34). Collected data erased. This includes manifolds used, filter hours, and last docking cycle. Call service. See Contact Information (page 4). Call service. See Contact Information (page 4). Remove the rover from the docker. Cycle docker power. Wait 60 seconds; try docking the rover again. Remove the rover from the docker. Cycle docker power. Wait 60 seconds; try docking the rover again. Call service. See Contact Information (page 4). Remove the manifold from the canister; dock the rover again. Call service. See Contact Information (page 4). Make sure facility water is supplied to the docker; dock the rover again. Call service. See Contact Information (page 4). EN 62 700000969828 Rev-AA DRAFT NOT FOR SALE CCOODDEE 3.12 MMEESSSSAAGGEE PPRRIIOORRIITTYY AACCTTIIOONN Dock Incomplete Notification (low) 3.13 3.15 4.1 4.3 4.4 5.0 6.X 7.X 7.7 7.8 8.X 12.X 13.X 13.6 14.X 18.3 Docker Not Ready Error (medium) Need To Dock Notification (low) Vacuum Error Error (medium) Empty Canister Error Notification (low) Prefill Error Error (medium) Filter Expired Notification (low) Empty Tank Error Error (medium) Level Sensor Error Error (medium) Prefill Error Error (medium) Level Sensor Error Error (medium) Level Sensor Error Error (medium) Vacuum Error Error (medium) Canister Pressure Notification (low) Vacuum Error Error (medium) Almost Full Notification (low) Remove the rover from the docker. Cycle docker power. Wait 60 seconds; try docking the rover again. Remove the rover from the docker. Cycle docker power. Wait 60 seconds; try docking the rover again. Dock the rover; the used rover has not been docked in 48 hours. Call service. See Contact Information (page 4). Dock the rover to remove clog from canister. See To DocktheRover (page 54). Dock the rover to fill prefill tank. ToAddCanisterPrefill Fluid (page 31). Replace fluid suction HEPA filter; reset filter life counter. See ToReplacetheHEPA Filter (page 52). Call service. See Contact Information (page 4). Call service. See Contact Information (page 4). Make sure facility water is supplied to the docker; dock the rover again. Call service. See Contact Information (page 4). Call service. See Contact Information (page 4). Call service. See Contact Information (page 4). Turn on suction to reduce the positive pressure in the canister. If this notification persists, call service. Call service. See Contact Information (page 4). Prepare to use an alternate source of suction, or empty the canister of fluid waste to prevent the loss of suction. 700000969828 Rev-AA 63 EN DRAFT NOT FOR SALE CCOODDEE 18.5 MMEESSSSAAGGEE Full PPRRIIOORRIITTYY Error (medium) 20.1 Audio Failure Error (medium) 21.0 22.0 22.1 22.2 24.11 24.13 24.15 Dial Error Error (medium) Manifold Error Error (medium) Manifold Error Notification (low) Expired Manifold Notification (low) Install new manifold. Used Manifold Notification (low) AACCTTIIOONN Use an alternate source of suction, or empty the canister to restore lost suction to the canister. 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 service. Call service. See Contact Information (page 4). Call service. See Contact Information (page 4). Install new manifold. See To ReplacetheHEPAFilter

(page 52). Install new manifold before performing the next surgical procedure. EN 64 700000969828 Rev-AA DRAFT NOT FOR SALE 66..44.. SSeerrvviiccee Stryker for service. only. the center. WWAARRNNIINNGG -- Do not disassemble, modify, or repair this product without the authorization of the manufacturer. Contact WWAARRNNIINNGG -- ALWAYS reprocess (clean, disinfect, sterilize if required) all potentially contaminated equipment BEFORE returning to Stryker. Stryker will not accept or process any potentially contaminated equipment. NNoottee -- Maintenance documentation for this product is available upon request to Stryker-authorized service personnel NNoottee -- For service information, contact your Stryker sales representative or call Stryker customer service. See Contact Information (page 4) section. Outside the US, contact your nearest Stryker subsidiary. 1. Contact your local Stryker service center to obtain a repair purchase order BEFORE sending a product return directly to 2. To expedite your processing, ALWAYS include the following information with your product return:

Contact name Contact address Contact phone number Repair purchase order number Part number(s) Serial number(s) Detailed reason for return 66..55.. DDiissppoossaall//RReeccyyccllee In accordance with European Directive 2012/19/EU on Waste Electrical and Electronic Equipment

(WEEE) as amended product should be collected separately for recycling. Do not dispose of as unsorted municipal waste. Contact local distributor for disposal information. Ensure infected equipment is decontaminated prior to recycling. Collect batteries separately for recycling per European Community Batteries Directive. 700000969828 Rev-AA 65 EN DRAFT NOT FOR SALE MMooddeell::

Neptune S Rover (REF 0711-001-000) 66..66.. SSppeecciiffiiccaattiioonnss PPoowweerr RReeqquuiirreemmeennttss::

DDiimmeennssiioonnss::

MMaassss::

120 V phase; X0 V receives power from docker REF 0702-014-000

(alternating current AC), 60 Hertz (Hz), X.0 Amps (A), single

(direct current DC), X A during docking procedure; rover XX mm [X.X inch] height, XX mm [X.X inch] width, XXX mm [X.X inch] length 85 kg [187 lb.] collection canister full; 106 kg [233 lb] fully loaded, includes maximum supported load of 21 kg [46 lb] on the work surface NNoottee -- A Stryker SafeAir Combi or Compact Console may be attached to the work surface of the rover using the Neptune S Console Bracket. SeeFor UseWith (page 12). MMaatteerriiaall::

REACH, RoHS materials?

Reticulated foam that prevents frothing: PVC Coated Polyester 10 PPI. MMooddee ooff OOppeerraattiioonn::

Continuous SSoouunndd PPrreessssuurree::

Medium Priority Alert, X - X dB (not adjustable, see IEC 60601-1-8: 200X

(Second Edition) + AM1:20XX) AAddjjuussttaabbllee SSuuccttiioonn LLiimmiitt::

50 to 520 mm-Hg; measured with all ports closed NNoottee -- 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 mm-Hg. VVaaccuuuumm MMeeaassuurreemmeenntt AAccccuurraaccyy::

5% of full scale ( 26 mm-Hg, 3.47 kPa)include kPa accuracy?

SSuuccttiioonn LLiimmiitt AAccccuurraaccyy::

< 26 mm-Hg (3.47 kPa) or 10% of setting VVoolluummee::

8-liter capacity (8-liter canister) VVoolluummee OOvveerrffiillll PPrrootteeccttiioonn::

Software and Mechanical Float? Do we need more detail here?

VVoolluummee MMeeaassuurreemmeenntt AAccccuurraaccyy::

8-liter canister, 120 mL NNoottee -- The canister has increment marks of 10 mL. IInncclliinneedd PPllaannee ooff OOppeerraattiioonn::

2.5 degrees EEqquuiippmmeenntt TTyyppee::

EEqquuiippmmeenntt CCllaassssiiffiiccaattiioonn::

Class I Medical Electrical (ME) Equipment IInnggrreessss PPrrootteeccttiioonn ((IIPP))::

IPX0 NNoottee -- Volume measurement accuracy specified does not account for fluid evaporation or an inclined plane of operation that exceeds the specified range. Type CF Applied Part EN 66 700000969828 Rev-AA DRAFT NOT FOR SALE LLEEDD CCllaassssiiffiiccaattiioonn -- IIRR CCoommmmuunniiccaattiioonn WWiinnddooww::

GGrroouunndd TTyyppee::

MMooddeell::

DDiimmeennssiioonnss::

MMaassss::

MMaatteerriiaall::

MMooddeell::

DDiimmeennssiioonnss::

MMaassss::

MMaatteerriiaall::

WWAARRNNIINNGG -- IINNVVIISSIIBBLLEE LLEEDD RRAADDIIAATTIIOONN:: 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 may pose an eye injury hazard. warning may change - based on a IEC 608251 standard product safety is not going to use anymore; new standard IEC 62471 requirement Protective Earth (ground); when connected to facility power Neptune S V2 Specimen Collection Manifold Kit (REF 0750-200-000) XX mm [X.X inch] height, XX mm [X.X inch] width, XXX mm [X.X inch] length XX kg [XX lb.]

XX kg [XX lb.]

Neptune S V2 4Port Manifold (REF 0750-400-000) XX mm [X.X inch] height, XX mm [X.X inch] width, XXX mm [X.X inch] length TTaabbllee 3344 EEnnvviirroonnmmeennttaall CCoonnddiittiioonnss aanndd LLiimmiittaattiioonnss EEnnvviirroonnmmeennttaall LLiimmiittaattiioonnss OOppeerraattiioonn aanndd MMaaiinntteennaannccee SSttoorraaggee aanndd TTrraannssppoorrttaattiioonn ((bbeeffoorree iinniittiiaall uussee)) SSttoorraaggee aanndd TTrraannssppoorrttaattiioonn ((aafftteerr iinniittiiaall uussee)) TTeemmppeerraattuurree::

RReellaattiivvee HHuummiiddiittyy::

AAttmmoosspphheerriicc PPrreessssuurree::

10% ????

700000969828 Rev-AA 67 EN DRAFT NOT FOR SALE 66..77.. PPoowweerr CCoorrdd SSppeecciiffiiccaattiioonnss NNoottee -- The general power cord specifications indicate power cord requirements only, not device requirements. MMooddeell::

RREEFF::

RRaattiinnggss::

TTaabbllee 3355 GGeenneerraall PPoowweerr CCoorrdd SSppeecciiffiiccaattiioonnss 120 VAC Neptune S Rover 230 VAC Neptune S Rover 100 VAC Neptune S Rover 0711-001-000, 0711-004-

000 0711-002-000XX 0711-003-000 Current: 15 A 10 A [minimum]

16 A Voltage (nominal): 125 VAC Frequency: 60 Hz 250 VAC 50 Hz 110 VAC minimum 50/60 Hz Temperature: 105C minimum IEC 60320 C13 5.5 m CCoonndduuccttoorr SSiizzee::

CCoonnnneeccttoorr TTyyppee::

CCoorrdd LLeennggtthhss::

CCoorrdd TTyyppee::

DDiieelleeccttrriicc WWiitthhssttaanndd::

14 AWG 1.5 mm2 2 mm2 SJT, H05VV-F, HVCTF, RVV or equivalent (unshielded) 1500 VAC for 60 seconds between line and protective earth and between neutral and protective earth EN 68 700000969828 Rev-AA DRAFT NOT FOR SALE TTaabbllee 3366 CCoouunnttrryy--ssppeecciiffiicc PPoowweerr CCoorrdd SSppeecciiffiiccaattiioonnss PPlluugg TTyyppee11 CCoorrdd SShhiieellddiinngg CCoorrdd LLeennggtthh PPaarrtt NNuummbbeerr B3 E/F G L Shielded Unshielded Unshielded Unshielded 3.7 m 5.5 m?

3.0 m 5.5 m?

3.0 m 5.5 m?

2.5 m 5.5 m?

LLoocckkiinngg MMeecchhaanniissmm NO YES?

NNaattiioonnaall SSttaannddaarrdd22 0996851010 UL or CSA YES 0996851025 CEE 7/7 YES 0996851027 BS 1363 NO YES?

0996851032 CEI 2350 1The facility power (mains) plug shall have a ground/earthing pin. 2The power cord shall meet the cited national standard. 3The Canadian and United States (US) power supply cord shall have a tag or label in English and French indicating that GROUNDING RELIABILITY CAN ONLY BE ACHIEVED WHEN EQUIPMENT IS CONNECTED TO AN EQUIVALENT RECEPTACLE MARKED HOSPITAL ONLY OR HOSPITAL GRADE or equivalent wording. Agency Approval:

CSA Certified for Canada and US or UL Recognized for Canada and US 700000969828 Rev-AA 69 EN DRAFT NOT FOR SALE 66..88.. EElleeccttrroommaaggnneettiicc CCoommppaattiibbiilliittyy product safety to verify accuracy of this information GGuuiiddaannccee aanndd mmaannuuffaaccttuurreerrss ddeeccllaarraattiioonn -- eelleeccttrroommaaggnneettiicc eemmiissssiioonnss The Neptune S Rover is intended for use in the electromagnetic environment specified below. The customer or the user of the Neptune S Rover should assure that it is used in such an environment. EEmmiissssiioonnss tteesstt CCoommpplliiaannccee EElleeccttrroommaaggnneettiicc eennvviirroonnmmeenntt -- gguuiiddaannccee RF emissions Group 1 RF emissions Class A CISPR 11 CISPR 11 Harmonic emissions Class A Neptune S Rover 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 electronic equipment. Neptune S Rover is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-

voltage power supply network that supplies buildings used for domestic purposes, provided the following warning is heeded:

IEC 61000-3-2 Voltage fluctuations/

flicker emissions IEC 61000-3-3 Complies WWAARRNNIINNGG -- This equipment/system is intended for use by healthcare professionals only. This equipment/system may cause radio interference or may disrupt the operation of nearby equipment. Mitigation measures may be necessary, such as reorienting or relocating the Neptune S Rover or shielding the location. GGuuiiddaannccee aanndd mmaannuuffaaccttuurreerrss ddeeccllaarraattiioonn -- eelleeccttrroommaaggnneettiicc iimmmmuunniittyy This Neptune S Rover is intended for use in the electromagnetic environment specified below. The customer or the user of the Neptune S Rover should assure that it is used in such an environment. IImmmmuunniittyy tteesstt IIEECC 6600660011 tteesstt lleevveell CCoommpplliiaannccee lleevveell Electrostatic discharge

(ESD) IEC 61000-4-2 8 kV contact 8 kV contact 2 kV, 4 kV, 8 kV, 15 kV air 2 kV, 4 kV, 8 kV, 15 kV air Electrical fast transient/burst IEC 61000-4-4 2 kV at 100 kHz repetition frequency for power supply lines 2 kV at 100 kHz repetition frequency for power supply lines Surge IEC 61000-4-5 1 kV at 100 kHz repetition frequency for input/output lines 1 kV at 100 kHz repetition frequency for input/output lines 0.5 kV, 1 kV line(s) to line(s) 0.5 kV, 1 kV line(s) to line(s) 0.5 kV, 1 kV, 2 kV line

(s) to earth 0.5 kV, 1 kV, 2 kV line

(s) to earth EElleeccttrroommaaggnneettiicc eennvviirroonnmmeenntt -- gguuiiddaannccee Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 20% ??. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. EN 70 700000969828 Rev-AA DRAFT NOT FOR SALE Voltage dips, short interruptions, and voltage variations on power supply input lines IEC 61000-4-11 GGuuiiddaannccee aanndd mmaannuuffaaccttuurreerrss ddeeccllaarraattiioonn -- eelleeccttrroommaaggnneettiicc iimmmmuunniittyy

<5% UT (>95% dip in UT ) for 0.5 cycle

<5% UT (>95% dip in UT ) for 0.5 cycle 40% UT (60% dip in UT ) for 5 cycles 0% UT (100% dip in UT ) for 0.5 cycle at 0, 45, 90, 135, 180, 225, 270, and 315 40% UT (60% dip in UT ) for 5 cycles 0% UT (100% dip in UT ) for 0.5 cycle at 0, 45, 90, 135, 180, 225, 270, and 315 0% UT (>100% dip in UT ) for 1 cycle at 0 0% UT (>100% dip in UT ) for 1 cycle at 0 70% UT (30% dip in UT ) for 25 and 30 cycles at 0 70% UT (30% dip in UT ) for 25 and 30 cycles at 0

<5% UT (>95% dip in UT ) for 5 seconds

<5% UT (>95% dip in UT ) for 5 seconds 0% UT (100% dip in UT ) for 250/300 cycles 0% UT (100% dip in UT ) for 250/300 cycles Mains power quality should be that of a typical commercial or hospital environment. If the user of the Neptune S Rover 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) magnetic field 3 A/m, 30 A/m at 50 and 60 Hz 3 A/m, 30 A/m at 50 and 60 Hz IEC 61000-4-8 Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NNoottee -- UT is the AC mains voltage prior to application of the test level. GGuuiiddaannccee aanndd mmaannuuffaaccttuurreerrss ddeeccllaarraattiioonn -- eelleeccttrroommaaggnneettiicc iimmmmuunniittyy The Neptune S Rover is intended for use in the electromagnetic environment specified below. The customer or the user of this Neptune S Rover should assure that it is used in such an environment. IImmmmuunniittyy tteesstt IIEECC 6600660011 tteesstt lleevveell CCoommpplliiaannccee lleevveell EElleeccttrroommaaggnneettiicc eennvviirroonnmmeenntt -- gguuiiddaannccee 700000969828 Rev-AA 71 EN DRAFT NOT FOR SALE GGuuiiddaannccee aanndd mmaannuuffaaccttuurreerrss ddeeccllaarraattiioonn -- eelleeccttrroommaaggnneettiicc iimmmmuunniittyy Conducted RF 3 V 0.15 MHz 80 MHz 3 V IEC 61000-4-6 Radiated RF IEC 61000-4-3 6 V in ISM bands between 0.15 MHz and 80 MHz 80%

AM at 1 kHz b 3 V/m 80 MHz to 2.7 GHz 80% AM at 1 kHz 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 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 28 V/m 450 MHz, FM 5 kHz deviation, 1 kHz sine, Maximum power = 2 W 9 V/m 710, 745, 780, 5240, 5500, 5785 MHz, pulse modulation 217 Hz, Maximum power = 0.2 W 9 V/m 710, 745, 780, 5240, 5500, 5785 MHz, pulse modulation 217 Hz, Maximum power = 0.2 W 28 V/m 810, 870, 930 MHz, pulse modulation 18 Hz, Maximum power = 2 W 28 V/m 810, 870, 930 MHz, pulse modulation 18 Hz, Maximum power = 2 W 28 V/m 1720, 1845, 1970, 2450 MHz, pulse modulation 217 Hz, Maximum power = 2 W 28 V/m 1720, 1845, 1970, 2450 MHz, pulse modulation 217 Hz, Maximum power = 2 W WWAARRNNIINNGG -- Portable RF equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Neptune S Rover, including cables specified by the manufacturer. Otherwise, degradation of the performance of this Neptune S Rover could result. Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a, should be less than the compliance level in each frequency range b. Interference may occur in the vicinity of equipment marked with the following symbol:

(non-ionizing electromagnetic radiation) NNoottee At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Neptune S Rover is used exceeds the applicable RF compliance level above, the Neptune S Rover should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Neptune S Rover. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. EN 72 700000969828 Rev-AA DRAFT NOT FOR SALE 66..99.. FFeeddeerraall CCoommmmuunniiccaattiioonnss CCoommmmiissssiioonn ((FFCCCC)) aanndd IInndduussttrryy CCaannaaddaa ((IICC)) CCoommpplliiaannccee NNoottee -- Changes or modifications not expressly approved by Stryker could void the user's authority to operate the equipment. 66..99..11.. MMaanniiffoolldd AAuutthheennttiiccaattiioonn FFCCCC IIddeennttiiffiiccaattiioonn ((IIDD)) FFCCCC IIDD:: QQ99RR--449922886666 This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. IICC IIddeennttiiffiiccaattiioonn

((IIDD)) IICC IIDD:: 449919AA--449922886666 NNoottee -- To ensure compliance with FCC and Innovation, Science and Economic Development Canada (ISED) Radio Frequency (RF) exposure requirements this device must be installed to provide a minimum of 20 cm between the device and people. Pour garantir la conformit aux exigences d'exposition RF de la FCC et d'ISED Canada, cet appareil doit tre install de manire laisser un minimum de 20 cm entre l'appareil et les personnes. NNoottee -- This device contains licence-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canadas licence-exempt RSS(s). Operation is subject to the following two conditions: (1) This device may not cause interference. (2) This device must accept any interference, including interference that may cause undesired operation of the device. Lmetteur/rcepteur exempt de licence contenu dans le prsent appareil est conforme aux CNR dInnovation, Sciences et Dveloppement conomique Canada applicables aux appareils radio exempts de licence. Lexploitation est autorise aux deux conditions suivantes : (1) Lappareil ne doit pas produire de brouillage; (2) Lappareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible den compromettre le fonctionnement. 66..99..22.. DDoocckkiinngg IInntteerrffaaccee FFCCCC CCoommpplliiaannccee This device complies with FCC 47 CFR Part 18 Inductive Coupling for power transfer for a cleaning cycle between the rover and docker. 700000969828 Rev-AA 73 EN DRAFT NOT FOR SALE 66..1100.. GGlloossssaarryy AAlleerrtt CCoonnddiittiioonn a potential or actual hazardous situation exists for which user AWARENESS or RESPONSE is required. IInnvvaalliidd MMaanniiffoolldd a manifold that may have been altered, damaged, or previously exposed to suction and has since expired. AApppplliieedd PPaarrtt a component of an electrical medical device that comes into physical contact with the patient during normal use to perform its function. The fluid suction tubing is an applied part. LLooww PPrriioorriittyy AAlleerrtt indicates user AWARENESS is required [product safety has indicated future action may be needed to address alerts.]

MMeeddiiuumm PPrriioorriittyy AAlleerrtt indicates PROMPT user RESPONSE is required. BBSS EENN IISSOO 1100007799--11:: 22000099,, ccllaauussee 99..44 the requirements in IEC 60601-1:1988, clause 16 apply; also the housing shall be constructed of fire-retarding material which withstands the needle-flame test specified in IEC 60695 2-2 when the flame is applied to any point on the inside or outside surface of the housing for 20 seconds. BBSS EENN IISSOO 1100007799--11:: 22001155 ++ AA11:: 22001199,, ccllaauussee 99..1111 interruption and restoration of the power supply to the suction equipment shall not cause any hazard, and the vacuum and flow rate shall not vary by more than 10% from the set value. DDoocckkeerr--RRoovveerr IInntteerrffaaccee includes four 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 and docker fluid couplings provide pathways for fluid waste outflow and clean water inflow to the rover canisters, and (4) infrared communication is used to exchange information between the docker and rover. NNeeww MMaanniiffoolldd a valid manifold; suction has never been applied to the manifold. NNoottiiffiiccaattiioonn indicates a low priority alert condition that will not prevent use of the rover. The rover will remain fully functional after experiencing a notification. EErrrroorr indicates a medium priority alert condition, including a software or hardware fault, or an unexpected operating condition. OOffff LLooaaddiinngg the contents of the rover canister is emptied into a facility waste disposal drain during docking. EExxppiirreedd MMaanniiffoolldd indicates 36 hours have elapsed since the new manifold was first exposed to suction. PPrreeffiillll FFlluuiidd the rover canister is prefilled with a water and detergent solution after each docking cycle; the solution initiates the breakdown of fluid waste collected during use. FFlluuiidd LLeevveell SSeennssoorr a sensor located in the collection canister that determines the current fluid volume level. The presence of prefill fluid ensures the sensor is always floating. FFlluuiidd SSttaacckkiinngg if the rover has sufficient fluid volume capacity in the collection canister, it may be used for more than one surgical procedure; fluid waste is stacked between procedures. PPrreeffiilllliinngg adding prefill fluid to the rover canister. UUsseedd MMaanniiffoolldd a valid manifold exposed to suction, but not yet expired. EN 74 700000969828 Rev-AA DRAFT NOT FOR SALE GGlluuttaarraallddeehhyyddee a toxic chemical used to clean and disinfect. VVaalliidd MMaanniiffoolldd a NEW or USED manifold (but not yet expired). IInnffrraarreedd CCoommmmuunniiccaattiioonn an information exchange method using a receiver, a transmitter, and invisible infrared energy. 700000969828 Rev-AA 75 EN DRAFT NOT FOR SALE Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: tthhee SSttrryykkeerr llooggoo. All other trademarks are trademarks of their respective owners or holders. MMaannuuffaaccttuurreedd BByy::

Stryker Instruments 1941 Stryker Way Portage, MI 49002 USA AAuutthhoorriizzeedd RReepprreesseennttaattiivvee iinn tthhee EEuurrooppeeaann CCoommmmuunniittyy//EEuurrooppeeaann UUnniioonn Stryker European Operations Limited Anngrove, IDA Business & Technology Park Carrigtwohill, Co Cork, T45 HX08 Ireland 700000969828 Rev-AA 2021-12 DRAFT NOT FOR SALE

Users Guide Orion Manifold Receptacle (MR) Printed Circuit Board Assembly (PCBA) Stryker PN: 700000492866 Document Rev: 1.1 REVISION HISTORY REVISION 1.0 INITIAL CREATION FOR ORION COMMENTS DATE 9/27/2021 G. ROCQUE AUTHOR 1.1 UPDATES FROM FCC REVIEW OF DOCUMENTATION 12/09/2021 G. ROCQUE The Orion Manifold Receptacle (MR) Printed Circuit Board Assembly (PCBA) is a custom designed circuit board intended to operate within the Orion Rover and next generation of Neptune product line. The Orion MR PCBA is made up of a mother board, Stryker PN 700000492877, and a RFID Reader daughter card, Stryker PN 0703-001-821. Together, both the mother board and RFID Reader daughter card constitute the Stryker MR PCBA, Stryker PN 700000492866. The mother board is manufactured by Stryker while the RFID Reader daughter card is manufactured by Feig Electronics, PN 4320.000.00. Description:

Features:

The MR PCBA is made up of an RFID interface circuit to communicate with the RFID Reader daughter card; an illumination circuit for the manifold receptacle; a manifold and door detection circuits; several DC to DC power supplies; a sprinkler controller circuit; canister, worksurface, and specimen illumination driver circuits; and a UART interface bus to communicate with the Rover Main Controller (RMC) PCBA. All of the MR PCBA features are custom to the Orion Rover system. The MR PCBA cannot operate on its own and is a slave sub-system within the Orion Rover system. A set of proprietary commands exist between the RMC PCBA and the MR PCBA to configure, perform execution of tasks, and transfer data upon command. The proprietary commands always originate from the master RMC PCBA and are responded to by the slave MR PCBA. Finally, the MR PCBA contains an integrated RFID antenna designed Page 1 of 3 to read passive HF RFID tags. The integrated RFID antenna is located on the mother board, Stryker PN 700000492877. The MR PCBA with RFID circuit is limited to Stryker products only and has been designed as a proprietary asset within Strykers product line. Additionally, the MR PCBA with RFID circuit is not intended for redistribution, sales, or re-use within any third party entities. Intended Use:

Technical Data:

Mechanical Data:

Housing: None provide, bare PCBA only; installed within the Orion Rover Dimensions: (W x H x D): 3.45inch x 0.64inch x 4.95inch (87.63mm x 16.26mm x 125.73mm) Pwr/Comm Connector: 6 Pin-Connector, Samtec, IPL1-103-01-L-D-RA-K, custom wire configuration Weight: 2.8 oz. (80g) Electrical Data:

Supply Voltage: 17 VDC to 41.2 VDC Current Draw: 0.3A Max at 36 VDC Roving Mode or 0.4A Max at 19 VDC Docking Mode Power Consumption: 10.8W Roving Mode or 7.6W Docker Mode Interfaces: RS485 Level, 115.2 kbps, Proprietary Communication Protocol Processor: Microchip dsPIC 33EP256MU810 and Fujitsu MB90F562B Main RFID Functional Properties:

Reader: Ability to detect, read, and write to passive HF RFID tags Operating Frequency: 13.56 MHz Distance: Short communication range, 1.5 or less Page 2 of 3 Ambient Conditions:

Temperature Range: 0C - 70C Humidity: 5 95% non-condensing Page 3 of 3

0711-001-000 Neptune S Rover 120V ~ 60Hz 6A 85 kg [187 lb] - collection canister full 109 kg [240 lb] - fully loaded, includes max supported load of 24 kg [53 lb] on the top surface Contains FCC ID: Q9R-492866 This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Stryker Instruments, 1941 Stryker Way Portage, MI 49002 USA (269) 323-7700 (800) 253-3210 Assembled in USA U.S. Patents: www.stryker.com/patents 700000926047 Rev-AC

Color Black ink; dieline is for reference only--do not print Material Stock #000025 White Paper High Gloss Roll w/Permanent Adhesive Finish N/A Dimensions 1.5 inch (width) x 0.5 inch with 0.0625 inch radius corners Notes Shall be compliant per ES-1168. Required to be compliant per ES-1005?

Yes No Description/Type NEPTUNE S WIRELESS ID LABEL Revision Part Number AB 700001005997 DSGN-fm-50366 Rev. AA Effective: Scope: KZO, IRE, SPR Process Owner: Tech Pubs Manager Page 1 of 1 M/N: Manifold Receptacle PCBAFCC ID: Q9R-492866IC: 4919A-492866700001005997 Rev-AB700000492866

Date: 10/13/2021 UL LLC 12 Laboratory Dr. Research Triangle Park, NC 27709 USA To whom it may concern:

I, the undersigned, hereby authorize UL LLC to act on our behalf in all manners relating to application for equipment authorization, including signing of all documents relating to these matters. Any and all acts carried out by UL Verification Services Inc. on our behalf shall have the same effect as acts of our own. I, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). In authorizing UL LLC as our representative, we still recognize that we are responsible to:

a) fulfill the requirements for the scope of certification requested, including implementing any appropriate changes requested by UL Verification Services Telecommunications Certification Body (TCB) and / or the FCC;

b) supply any and all information needed for the evaluation of the products for which certification is sought;

been granted;

c) make claims regarding certification only in respect of the scope for which certification has d) not use our product certification in such a manner as to bring the TCB or FCC into disrepute and to not make any statement regarding product certification which the TCB or FCC may consider misleading or unauthorized;

e) discontinue use of all advertising matter that contains any reference thereto and complies with any and all actions required by the FCC upon suspension or cancellation of certification;

f) use certification only to indicate that products are certified in conformity with specified standards;

g) endeavor to ensure that no certificate or report or any part thereof is used in a misleading manner, and any copies of the grants/certificates shall be reproduced in their entirety;

h) comply with the requirements of the TCB and FCC, including the use of marks and label information prescribed for the scope of certification, when making reference to product certification in communication media such as documents, brochure or advertisements;

i) comply with the requirements for certification, supply any information needed for evaluation of products to be certified and, where applicable, make provision for the participation of observers;

j) ensure that products marketed under the scope of the requested certification continue to comply with the certification requirements;

Stryker Instruments 1941 Stryker Way, Portage, MI 49024 USA | stryker.com k) provide a sample of a production unit for testing within 30 days of the request should this product be selected as part of either the TCBs or the FCCs market surveillance requirements;

l) keep a record of all complaints relating to products compliance with requirements of relevant standard; make records available to UL or FCC when requested; take appropriate action with respect to such complaints and any deficiencies found in the product that affect compliance with requirements for certification; document the actions taken with respect to complaints and/or deficiencies;

m) inform the TCB immediately of any changes that may affect its ability to comply with the certification requirements. This authorization is valid until January 31, 2022. Sincerely Yours, Stefan King Sr. Staff Engineer, Product Safety Stryker Instruments Stryker Instruments 1941 Stryker Way, Portage, MI 49024 USA | stryker.com

The purpose of this memo is to describe the differences between the 120V Neptune S rovers. These are the 120V Neptune S rover part numbers:

The differences between these models are the language translations and labelling. There is no mechanical or electrical difference between these part numbers. Date: 12/20/2021 IC Certification No: 4919A-492866 FCC ID: Q9R-492866

0711-001-000 (US rover) 0711-004-000 (Canada rover) 0711-005-000 (Spanish rover) Stefan King Sr. Staff Engineer, Product Safety Stryker Instruments Electronically signed by:

Stefan King Reason: I approve this document Date: Dec 20, 2021 15:52 EST Attestation Final Audit Report Created:

2021-12-20 By:

Status:

Signed Emily Warren (emily.warren@stryker.com) Transaction ID:

CBJCHBCAABAA2aK3omLr3QwiYqa8WWAatQpTdL_iTxxp 2021-12-20

"Attestation" History Document created by Emily Warren (emily.warren@stryker.com) 2021-12-20 - 8:39:26 PM GMT- IP address: 64.136.252.163 Document emailed to Stefan King (Stefan.King@stryker.com) for signature 2021-12-20 - 8:39:50 PM GMT Email viewed by Stefan King (Stefan.King@stryker.com) 2021-12-20 - 8:46:23 PM GMT- IP address: 104.47.57.254 Stefan King (Stefan.King@stryker.com) verified identity with Adobe Sign authentication 2021-12-20 - 8:52:19 PM GMT Document e-signed by Stefan King (Stefan.King@stryker.com) Signature Date: 2021-12-20 - 8:52:19 PM GMT - Time Source: server- IP address: 64.136.252.163 Agreement completed. 2021-12-20 - 8:52:19 PM GMT

Applicant/Grantee FCC ID:

Stryker Instruments Q9R-492866 Request for Modular Approval Request for Limited Modular Approval Requirements EUT Conditions Comply (Y/N) Single Modular Approval Requirements Section 15.212 Modular Transmitters The module does not have any shielding. The final assembly containing the module meets all the applicable RSS-

102 requirements. The module is intended to operate only within the Neptune S Rover. The instructions for use of the final assembly indicates, DO NOT disassemble, modify, service, or repair any equipment without the authorization of the manufacturer. N Y Y Y The module was tested for compliance within the host device (Neptune S Rover) and will only be used in this host. N 1 2 3 4 5 The radio elements of the modular transmitter must have their own shielding. The physical crystal and tuning capacitors may be located external to the shielded radio elements. The modular transmitter must have buffered modulation/data inputs (if such inputs are provided) to ensure that the module will comply with Part 15 requirements under conditions of excessive data rates or over-modulation. The modular transmitter must have its own power supply regulation. The modular transmitter must comply with the antenna and transmission system requirements of Sections 15.203, 15.204(b) and 15.204(c). The antenna must either be permanently attached or employ a unique antenna coupler (at all connections between the module and the antenna, including the cable). The professional installation provision of Section 15.203 is not applicable to modules but can apply to limited modular approvals under paragraph (b) of this section. The modular transmitter must be tested in a stand-alone configuration, i.e., the module must not be inside another device during testing for compliance with Part 15 requirements. Unless the transmitter module will be battery powered, it must comply with the AC line conducted requirements found in Section 15.207. AC or DC power lines and data input/output lines connected to the module must not contain ferrites, unless they will be marketed with the module (see Section 15.27(a)). The length of these lines shall be the length typical of actual use or, if that length is unknown, at least 10 centimeters to insure that there is no coupling between the case of the module and supporting equipment. Any accessories, peripherals, or support equipment connected to the module during testing shall be unmodified and commercially available

(see Section 15.31(i)). The modular transmitter must be equipped with either a permanently affixed label or must be capable of electronically displaying its FCC identification number.

(A) If using a permanently affixed label, the modular transmitter must be labeled with its own FCC identification number, and, if the FCC identification number is not visible when the module is installed inside another device, then the outside of the device into which the module is installed must also display a label referring to the enclosed module. This exterior label can use wording such as the following: Contains Transmitter Module FCC ID: XYZMODEL1 or Contains FCC ID:

XYZMODEL1. Any similar wording that expresses the same meaning may be used. The Grantee may either provide such a label, an example of which must be included in the application for equipment authorization, or, must provide adequate instructions along with the module which explain this requirement. In the latter case, a copy of these instructions must be included in the application for equipment authorization.

(B) If the modular transmitter uses an electronic display of the FCC identification number, the information must be readily accessible and visible on the modular transmitter or on the device in which it is installed. If the module is installed inside another device, then the outside of the device into which the module is installed must display a label referring to the enclosed module. This exterior label can use wording such as the following:

Contains FCC certified transmitter module(s). Any similar wording that expresses the same meaning may be used. The user manual must include instructions on how to access the electronic display. A copy of these instructions must be included in the application for equipment authorization. The modular transmitter must comply with any specific rules or operating requirements that ordinarily apply to a complete transmitter and the manufacturer must 6 7 Y Y provide adequate instructions along with the module to explain any such requirements. A copy of these instructions must be included in the application for equipment authorization. The modular transmitter must comply with any applicable RF exposure requirements in its final configuration. 8 Y A limited modular approval may be granted for single or split modular transmitters that do not comply with all of the above requirements, e.g., shielding, minimum signaling amplitude, buffered modulation/data inputs, or power supply regulation, if the manufacturer can demonstrate by alternative means in the application for equipment authorization that the modular transmitter meets all the applicable Part 15 requirements under the operating conditions in which the transmitter will be used. Limited modular approval also may be granted in those instances where compliance with RF exposure rules is demonstrated only for particular product configurations. The applicant for certification must state how control of the end product into which the module will be installed will be maintained such that full compliance of the end product is always ensured.

Date: 10/13/2021 Attn: FCC Office of Engineering and Technology / UL Verification Services TCB Subject:

Request for Confidentiality FCC ID:

Q9R-492866 To Whom It May Concern:

Schematic Diagram Block Diagram Theory of Operation Antenna Specification Pursuant to the provisions of Sections 0.457 and 0.459 of the Commissions rules (47 CFR 0.457, 0.459), we are requesting the Commission to withhold the following attachments as confidential document from public disclosure indefinitely. Above mentioned document contains detailed system and equipment description are considered as proprietary information in operation of the equipment. The public disclosure of above documents might be harmful to our company and would give competitor an unfair advantage in the market. In additional to above mentioned documents, pursuant to Public Notice DA 04-1705 of the Commissions policy, in order to comply with the marketing regulations in 47 CFR 2.803 and the importation rules in 47 CFR 2.1204, while ensuring that business sensitive information remains confidential until the actual marketing of newly authorized devices. We are requesting the commission to grant short-term confidentiality request on the following attachments until May 1, 2022. External Photos Internal Photos Test Setup Photos User Manual It is our understanding that all measurement test reports, FCC ID label format and correspondent during certification review process cannot be granted as confidential documents and those information will be available for public review once the grant of equipment authorization is issued. Best Regards Stefan King Sr. Staff Engineer, Product Safety Stryker Instruments Stryker Instruments 1941 Stryker Way, Portage, MI 49024 USA | stryker.com