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  9. Stryker Neptune S User manual

Stryker Neptune S User manual

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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
0711-003-000
112200VV NNeeppttuunnee SS RRoovveerr ((CCAA))
0711-004-000
VV22 SSppeecciimmeenn CCoolllleeccttiioonn MMaanniiffoolldd KKiitt
0750-200-000
VV22 44--PPoorrtt MMaanniiffoolldd
0750-200-000
EN
700000969828 Rev-AA 2021-12
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 11––880000––555500––77883366.
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 patient’s 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
[email protected]
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.
CCoonnnneeccttiioonn SSaaffeettyy
WWAARRNNIINNGG
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.
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 institution’s 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
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.
WWAARRNNIINNGG
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.
EEnnvviirroonnmmeennttaall SSaaffeettyy
WWAARRNNIINNGG
FFIIRREE HHAAZZAARRDD
• Do not use this product in areas in which flammable anesthetics or flammable agents are mixed with air, oxygen, or
nitrous oxide.
Failure to comply may cause a fire and result in burn injury or property damage.
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.
EN 6 700000969828 Rev-AA
DRAFT NOT FOR SALE
BBiioollooggiiccaall SSaaffeettyy
WWAARRNNIINNGG
• Always follow the current local regulations and procedures governing biohazard waste to safely handle and dispose of
surgical waste.
Failure to comply may cause infection and result in healthcare staff injury.
WWAARRNNIINNGG
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.
WWAARRNNIINNGG
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.
11..88.. IInntteennddeedd UUsseerrss
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..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