Neptune 3 Instructions for Use sw ver 002.004.xxx Rev B Nov 2017

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0703-002-700 Rev-B

WARNING Failure to comply could result in serious injury or death.

DO NOT connect directly to chest tubes.

DO NOT connect directly to tracheal tubes.

DO NOT connect to closed wound drains.

ALWAYS use the minimum suction limit required to achieve the desired clinical outcome.

Only trained and experienced healthcare professionals may use this equipment. For more information, including safety information or in-service training, contact your Stryker sales representative or call Neptune Customer Service at 1-800-550-7836.

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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 3 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 3 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 3 Rover to a closed wound drainage system.

For training information, visit www.neptunecustomercare.com.

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Contents 1 Introduction . . . . . . . . . . . . . . . . . . . . 7 1.1 Audience . . . . . . . . . . . . . . . . . . . 7 1.2 Conventions . . . . . . . . . . . . . . . . . . 7 1.3 Contact Information . . . . . . . . . . . . . . . 7 2 Indications For Use . . . . . . . . . . . . . . . . . 7 3 Contraindications . . . . . . . . . . . . . . . . . 7 4 Safety Directives . . . . . . . . . . . . . . . . . . 8 4.1 General Safety . . . . . . . . . . . . . . . . . 8 4.2 Connection Safety . . . . . . . . . . . . . . . 8 4.3 Suction Safety . . . . . . . . . . . . . . . . . 8 4.4 Electrical Safety . . . . . . . . . . . . . . . . 9 4.5 Environmental/Biological Safety . . . . . . . . . 9 5 System Overview . . . . . . . . . . . . . . . . . 10 5.1 Operation . . . . . . . . . . . . . . . . . . . 10 5.2 Components and User Interface . . . . . . . . 12 5.3 For Use With . . . . . . . . . . . . . . . . . 13 5.4 Documentation . . . . . . . . . . . . . . . . 13 6 Features . . . . . . . . . . . . . . . . . . . . . 14 6.1 Hardware Interface . . . . . . . . . . . . . . 14 6.1.1 Rover Front View . . . . . . . . . . . . . . 14 6.1.2 Rover Back View... 15 6.2 Software Interface . . . . . . . . . . . . . . . 16 6.2.1 Safety Information Screens . . . . . . . . 16 6.2.2 Menu Structure . . . . . . . . . . . . . . 17 6.2.3 Screens, Dialogs, and Drop-downs . . . . . 18 6.2.3.1 Main Display Control Screen Areas . . . 18 6.2.3.2 Typical Settings Dialog Areas . . . . . . 19 6.2.3.3 Typical Docking Mode Screen Areas . . 20

8 Instructions . . . . . . . . . . . . . . . . . . . . 28 8.1 Before First Use . . . . . . . . . . . . . . . . 28 8.1.1 To Unpack the Rover . . . . . . . . . . . . 28 8.1.2 To Add Canister Prefill Fluid . . . . . . . . 28 8.1.3 To Test the Rover . . . . . . . . . . . . . 28 8.1.3.1 To Connect Power to the Rover . . . . . 28 8.1.3.2 To Test Fluid Suction . . . . . . . . . . 28 8.1.3.3 To Test IV Pole Height Adjustment...30 8.1.3.4 To Test Smoke Evacuation . . . . . . . 30 8.1.4 To Adjust the Rover Settings . . . . . . . . 31 8.2 Before the Procedure . . . . . . . . . . . . . 32 8.2.1 To Prepare the Rover . . . . . . . . . . . 32 8.2.2 To Install Disposable Components . . . . . 33 8.2.2.1 To Prepare for Fluid Suction . . . . . . 33 8.2.2.2 To Prepare for Smoke Evacuation . . . 34 8.2.2.3 To Prepare the IV Pole . . . . . . . . 34 8.3 During the Procedure . . . . . . . . . . . . . 35 8.3.1 To Operate the Rover . . . . . . . . . . . 35 8.3.1.1 To Control Fluid Suction . . . . . . . . 36 8.3.1.2 To Control Smoke Evacuation . . . . . . 36 8.3.1.3 To Manage a Full Canister . . . . . . . 37 8.4 After the Procedure . . . . . . . . . . . . . . 40 8.4.1 To Remove Disposable Components . . . . 40 8.4.1.1 To Remove Suction Components . . . . 40 8.4.1.2 To Remove Evacuator Components . . . 41 8.4.1.3 To Remove Fluid Bag(s) . . . . . . . . 41 8.4.2 To Shut Down and Relocate the Rover . . . 41 8.4.2.1 To Remove Power From the Rover . . . 41 8.4.2.2 To Prepare the Rover for Relocation . . 42 8.4.2.3 To Relocate the Rover . . . . . . . . . 42

6.2.3.4 Typical Notification or Error Drop-down Areas . . . . . . . . . . . . . . . . . . . . . 21

8.4.3 To Dock the Rover . . . . . . . . . . . . . 42

6.2.3.5 Top Display Screen Areas . . . . . . . 22

8.4.3.1 To Prepare the Docker . . . . . . . . . 43

7 Definitions . . . . . . . . . . . . . . . . . . . . 23

8.4.3.2 To Perform a Docking Cycle . . . . . . 43

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9 Inspection and Maintenance . . . . . . . . . . . . 45 10 Cleaning and Disinfection . . . . . . . . . . . . . 46 10.1 Recommended Equipment and Materials...46 10.2 To Wipe Down the Rover . . . . . . . . . . . 46 11 Storage and Handling . . . . . . . . . . . . . . 47 12 Disposal/Recycle . . . . . . . . . . . . . . . . . 47 13 Troubleshooting . . . . . . . . . . . . . . . . . 48 13.1 Rover Operation . . . . . . . . . . . . . . . 48 13.2 Docking Station Operation . . . . . . . . . . 50 13.3 Troubleshooting Codes . . . . . . . . . . . . 52 14 Specifications . . . . . . . . . . . . . . . . . . 54 15 Electromagnetic Compatibility . . . . . . . . . . 56 16 Radio Frequency Compliance . . . . . . . . . . . 62 16.1 Manifold Authentication . . . . . . . . . . . . 62 16.1.1 FCC Compliance . . . . . . . . . . . . . 62 16.1.2 Radio License . . . . . . . . . . . . . . 62 16.2 Docking Interface . . . . . . . . . . . . . . . 62 16.2.1 FCC Compliance . . . . . . . . . . . . . 62 17 Software License Notices . . . . . . . . . . . . . 62 18 Trademark Statement . . . . . . . . . . . . . . . 62 19 Glossary . . . . . . . . . . . . . . . . . . . . . 63

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List of Figures Figure 1 – To Collect Fluid Waste . . . . . . . . . . . 10 Figure 2 – Fluid Stacking . . . . . . . . . . . . . . 10 Figure 3 – To Empty the Canisters . . . . . . . . . . 10 Figure 4 – To Clean the Canisters . . . . . . . . . . 11 Figure 5 – To Evacuate Surgical Smoke . . . . . . . . 11 Figure 6 – To Adjust IV Pole Height . . . . . . . . . . 11 Figure 7 – Components and Interface Diagram . . . . 12 Figure 8 – Rover Front View . . . . . . . . . . . . . 14 Figure 9 – Rover Back View . . . . . . . . . . . . . 15 Figure 10 – Top Display WARNING Screen . . . . . . 16 Figure 11 – Main Display WARNING Screen . . . . . . 16 Figure 12 – Control Screen Menu Structure . . . . . . 17 Figure 13 – Roving Mode (Control) Screen . . . . . . 18 Figure 14 – Accessories Dialog . . . . . . . . . . . . 19 Figure 15 – Docking Mode Screen . . . . . . . . . . 20 Figure 16 – Notification Drop-down . . . . . . . . . . 21 Figure 17 – Top Display Screen . . . . . . . . . . . . 22 Figure 18 – To Connect Power . . . . . . . . . . . . 28 Figure 19 – Set Up System Screen . . . . . . . . . . 29 Figure 20 – To Start and Adjust Fluid Suction . . . . . 29 Figure 21 – To Test the Powered IV Pole . . . . . . . 30 Figure 22 – Evacuate Smoke Dialog . . . . . . . . . 30 Figure 23 – Settings Menu Dialog . . . . . . . . . . . 31 Figure 24 – Preferences Dialog . . . . . . . . . . . . 31 Figure 25 – To Connect Power . . . . . . . . . . . . 32 Figure 26 – To Prepare for Fluid Suction . . . . . . . 33 Figure 27 – Reset Volumes Dialog . . . . . . . . . . 33 Figure 28 – To Prepare for Smoke Evacuation . . . . . 34 Figure 29 – To Use the Powered IV Pole . . . . . . . 34

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Figure 39 – To Dispose of Suction Components . . . . 41 Figure 40 – To Remove Evacuator Components . . . . 41 Figure 41 – To Remove Fluid Bag(s) . . . . . . . . . 41 Figure 42 – To Remove Power . . . . . . . . . . . . 41 Figure 43 – Transport Configuration . . . . . . . . . . 42 Figure 44 – To Prepare the Docker . . . . . . . . . . 43 Figure 45 – To Dock the Rover . . . . . . . . . . . . 43 Figure 46 – Docking Mode Screen - Normal Wash . . . 44 Figure 47 – To Wipe Down the Rover . . . . . . . . . 47

List of Tables Table 1 – Components and Accessories . . . . . . . 13 Table 2 – Component Instructions for Use . . . . . . . 13 Table 3 – Control Screen Buttons . . . . . . . . . . . 23 Table 4 – Symbols . . . . . . . . . . . . . . . . . . 26 Table 5 – Suction Limit Ranges and Colors . . . . . . 27 Table 6 – Title Area Colors . . . . . . . . . . . . . . 27 Table 7 – Button Colors . . . . . . . . . . . . . . . 27 Table 8 – Manifold Symbol Colors . . . . . . . . . . 27 Table 9 – Canister Symbol Colors . . . . . . . . . . 27 Table 10 – Message Area Colors . . . . . . . . . . . 27 Table 11 – Audible Event Indicators . . . . . . . . . . 27 Table 12 – Abbreviations . . . . . . . . . . . . . . . 27 Table 13 – Components Supplied with Rover . . . . . 28 Table 14 – Smoke Evacuator Modes of Operation . . . 30 Table 15 – Rover Settings Options . . . . . . . . . . 31 Table 16 – High Suction Visual and Audible Indicators . 36 Table 17 – Fluid Volume Indicators . . . . . . . . . . 37 Table 18 – Docking Cycle Options . . . . . . . . . . 44 Table 19 – Inspection Schedule and Criteria . . . . . 45

Figure 30 – To Start and Adjust Fluid Suction . . . . . 36 Figure 31 – Almost Full Canister Condition . . . . . . 37 Figure 32 – Full Canister Condition . . . . . . . . . . 38 Figure 33 – Empty 4-Liter Canister Dialog . . . . . . . 38 Figure 34 – Emptying 4-Liter Canister Screen . . . . . 38 Figure 35 – Prefilling 4-Liter Canister Screen . . . . . 38 Figure 36 – To Relocate the Manifold . . . . . . . . . 39 Figure 37 – To Gather Suction Components . . . . . . 40 Figure 38 – To Discontinue Fluid Suction . . . . . . . 40

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1 Introduction

1.3 Contact Information

This instructions for use manual contains information intended to ensure the safe, effective, and compliant use of your product.

For additional information, including safety information, or in-service training, contact your Stryker sales representative or call Stryker Neptune Customer Service at 1-800-550-7836. Outside the US, contact your nearest Stryker subsidiary.

Keep and consult this reference manual during the life of the product.

1.1 Audience

2 Indications For Use

This manual is intended for in-service trainers, surgeons, anesthetists, circulating nurses, surgical assistants, biomedical equipment technicians, and housekeeping staff.

The Neptune 3 Waste Management System is intended to be used in the operating room, pathology, surgical centers, and doctor’s offices to collect and dispose of surgical fluid waste as well as collect smoke generated from electrocautery or laser devices.

1.2 Conventions The following conventions are used in this manual: WARNING

CAUTION

NOTE

A warning highlights a safety-related issue. ALWAYS comply with this information to prevent patient or healthcare staff injury. A caution highlights a product reliability issue. ALWAYS comply with this information to prevent product damage. A note supplements and/or clarifies procedural information.

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3 Contraindications The Neptune 3 Waste Management System is contraindicated against: ▪▪ Connection directly to chest tubes. ▪▪ Connection to closed wound drainage systems.

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4 Safety Directives

4.2 Connection Safety WARNINGS:

4.1 General Safety WARNINGS: ▪▪ Before using this equipment, or any component compatible with this equipment, read and understand the instructions for use. Pay particular attention to safety information. Become familiar with the equipment before use. ▪▪ Only healthcare professionals trained and experienced in the use of this medical device should operate this equipment. ▪▪ Healthcare professionals should be thoroughly familiar with the instructions for use, performance characteristics, and the indicated, contraindicated, and intended uses of this equipment. Contact your Stryker sales representative or Stryker Neptune Customer Service for in-service training. See Section 1.3 Contact Information.

INAPPROPRIATE CONNECTION HAZARD ▪▪ 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 –– Organ stabilizer/positioner devices Death or serious injury can result from inappropriate connections.

4.3 Suction Safety WARNINGS: HIGH SUCTION HAZARD MAX = 520 mm-Hg [69 kPa]

▪▪ The healthcare professional performing any procedure is responsible for determining the appropriateness of this equipment and the specific technique used for each patient. Stryker, as a manufacturer, does not recommend surgical procedure or technique.

▪▪ The effectiveness of aspiration is dependent upon the intensity of the suction applied.

▪▪ DO NOT disassemble, modify, service, or repair any equipment without the authorization of the manufacturer. Call Stryker Neptune Customer Service. See Section 1.3 Contact Information.

▪▪ ALWAYS follow your institution’s guidelines for suction limits.

▪▪ Upon initial receipt and before each use, inspect each component for damage. DO NOT use any equipment if damage is apparent or the inspection criteria are not met. See Table 19 Inspection Schedule and Criteria. ▪▪ ALWAYS operate the equipment within the specified environmental condition values. See Section 14 Specifications. ▪▪ The collection canister scale, top display, and main display are not diagnostic tools. DO NOT use the scale or either display to determine the amount of fluid lost from or retained by the patient.

▪▪ ALWAYS use the minimum suction limit range required to achieve the desired clinical outcome.

▪▪ The suction limit range of each collection canister may be adjusted by the appropriate suction control dial on the 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: 2009, clause 13.8. Use caution when activating suction with a high suction limit range. Death or serious injury can result from improper suction levels.

▪▪ DO NOT cover the top display or main display with drapes or other objects. ALWAYS make sure the top display and main display can be clearly seen.

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4.4 Electrical Safety WARNINGS: ELECTROMAGNETIC INTERFERENCE HAZARD ▪▪ 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 medical electrical equipment. Install and place this medical electrical equipment into service according to the EMC information contained in this manual. See Section 15 Electromagnetic Compatibility. Portable and mobile radio frequency (RF) communications equipment can affect the function of this medical electrical equipment.

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a written Exposure Control Plan. The Exposure Control Plan is designed to eliminate or minimize employee exposure through use of personal protective equipment (PPE), appropriate vaccinations (for example, hepatitis B), and other control measures. ALWAYS wear PPE when operating or handling this equipment. ▪▪ ALWAYS follow local regulations regarding proper handling and disposal of biohazard waste. Failure to comply may cause infection and result in healthcare staff injury. CONTAMINATION HAZARD ▪▪ DO NOT collect fluids from patients being treated with radioisotopes or hazardous chemical agents. ▪▪ ALWAYS follow local regulations for safe handling, recycling, and disposal of biohazard fluid waste and equipment. See Section 12 Disposal/Recycle.

▪▪ DO NOT stack or place equipment adjacent to the rover. If such a configuration is necessary, observe the configuration to ensure that electromagnetic interference does not degrade performance.

Failure to comply may cause environmental contamination and result in injury.

▪▪ DO NOT use the rover in an MRI environment. Using the rover in an MRI environment could affect the function of the system.

▪▪ ALWAYS clean and disinfect the equipment as indicated upon initial receipt and before each use.

ELECTRICAL SHOCK HAZARD

▪▪ DO NOT reuse, reprocess, or repackage a manifold that is intended for single use only.

▪▪ ALWAYS connect this equipment to a hospitalgrade, facility power receptacle with protective earth (ground). ▪▪ DO NOT touch or make contact with the rover and patient simultaneously. Failure to comply may cause electrical shock and result in patient or healthcare staff injury.

4.5 Environmental/Biological Safety WARNINGS: FIRE HAZARD: DO NOT use this equipment 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. See BS EN ISO 10079-1: 2009, clause 9.4. BLOODBORNE PATHOGEN HAZARD

INFECTION HAZARD

▪▪ DO NOT place the rover within the sterile field.

–– A single use device may not withstand chemical, chemical vapor, or high temperature sterilization reprocessing. –– Design features may make cleaning and disinfection difficult. –– Reuse may create a contamination risk or compromise structural integrity resulting in operational failure. –– Critical product information may be lost during repackaging. Failure to comply may lead to infection or cross infection and result in patient and/or healthcare staff injury. FLUID WASTE LEAKAGE HAZARD: ALWAYS make sure rover power is ON when collecting fluid waste. The rover can only detect full canisters if the rover power is ON. If rover power is OFF, fluid waste leakage can occur.

▪▪ The Bloodborne Pathogens Standard provided by the United States Occupational Safety and Health Administration (US OSHA 29 CFR 1910.1030) requires those employers with employees having occupational exposure to potentially infectious materials to establish

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5 System Overview 5.1 Operation The Stryker Neptune 3 Rover (rover) is a mobile unit used to suction and collect fluid waste and evacuate surgical smoke from a surgical site. The rover also has a heightadjustable, powered IV pole. During collection, fluid waste is removed from the surgical site through suction tubing connected to inlet ports of manifold(s) installed in the rover. The fluid waste is collected in the canister(s) of the rover (Figure 1). The two-canister design allows separate suction limit ranges and fluid volume measurement capability. However, both canisters use a single vacuum pump. The vacuum pump exhaust and canister exhaust are filtered.

Figure 2 – Fluid Stacking After collection, the rover is relocated and connected to the Stryker Docking Station (docker). Once the rover is connected to the docker, the emptying of the fluid waste and cleaning of the canisters occurs automatically (Figure 3).

Figure 1 – To Collect Fluid Waste Manifolds and suction tubing are single-use disposables and must be replaced between patients. However, it may not be necessary to empty the contents of the rover’s collection canisters. If the rover display indicates sufficient fluid volume capacity in one or both canisters, the rover may be used for additional surgical procedures. This concept is known as fluid stacking (Figure 2). See Section 19 Glossary.

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Figure 3 – To Empty the Canisters

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The rover canisters are rinsed with clean water and Neptune Docking Detergent REF 0700-001-026 to clean the canisters of any residual fluid waste (Figure 4).

Figure 4 – To Clean the Canisters

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The height of the IV pole may be adjusted by touching and holding buttons on the control screen (Figure 6).

Figure 6 – To Adjust IV Pole Height

Surgical smoke may also be evacuated from the surgical site through smoke tubing connected to the smoke evacuator filter installed in the rover. The surgical smoke is filtered inside the rover (Figure 5).

Figure 5 – To Evacuate Surgical Smoke

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5.2 Components and User Interface A complete Neptune Waste Management System consists of a rover with an installed fluid suction High Efficiency Particulate Air (HEPA) filter, a docker, and various single-use, disposable devices, including one manifold per collection canister, and fluid suction tubing. A smoke evacuator Ultra Low Penetration Air (ULPA) filter and smoke evacuator tubing may also be required (Figure 7). See Section 5.3 For Use With. The user interface provides complete control over functionality and provides audible, visual, and tactile feedback of status. The user interface elements include one main display with touch capability, two suction control dials, two manifold receptacle suction indicators and one top display (Figure 7, Figure 8, and Figure 9).

Touch Display

Suction Indicator

Suction Dials

Top Display QRC

Speaker 4L Canister

Fluid Tubing

Manifold

Suction Indicator Smoke Tubing

Smoke ULPA Filter

Fluid Tubing

Manifold

20 L Canister Suction HEPA Filter

Communication Window

ROVER

Docker Interface

Communication Windows Rover Interface

DOCKER Required Components

User Interface

Figure 7 – Components and Interface Diagram

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5.3 For Use With

5.4 Documentation

Table 1 – Components and Accessories

Table 2 – Component Instructions for Use

This table identifies required components and optional accessories used with the rover to accomplish its intended use. Components and accessories are sold separately.

This table identifies the instructions for use supplied with required components.

DESCRIPTION Docking Station Neptune 2 Docking Station (120 VAC) Neptune 2 Docking Station (230 VAC) Docking Station Accessory Neptune Docking Detergent (2/pack) Fluid Filter Fluid Suction HEPA Filter (1 each) Manifold(s) Four-port Manifold (20/pack) Single-port Manifold (20/pack) Four-port Manifold with Specimen Collection (20/pack) Fluid Suction Tubing Medical grade fluid suction tubing with 3/8 inch connector Smoke Filter Smoke Evacuator ULPA Filter (4/pack) Smoke Tubing Medical grade smoke evacuator tubing with a 1/4 inch, 3/8 inch, or 7/8 inch connector Smoke (Evacuator)Tubing, 3/8 inch x 10 feet (10/pack) Smoke (Evacuator) Tubing, 7/8 inch x 10 feet (10/pack) Smoke (Evacuator) Tubing, 7/8 inch x 10 feet with Wand (10/pack)

REF 0702-014-000 0702-015-000

Instructions for Use Neptune 2 Docking Station Disposable Manifolds Fluid Suction HEPA Filter Smoke Evacuator ULPA Filter

REF 0702-014-700 0702-020-700 0702-034-700 0702-040-700

0700-001-026 0702-034-000 0702-020-000 0702-025-000 0702-020-001

Commercially available 0702-040-000 Commercially available 0702-045-023 0700-025-000 0700-026-000

NOTE: For a complete list of components and accessories or ordering information, contact your Stryker sales representative or call Stryker Neptune Customer Service. See Section 1.3 Contact Information. Outside the US, contact your nearest Stryker subsidiary.

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6 Features

D

6.1 Hardware Interface 6.1.1 Rover Front View J

E

K

I H G F E

4L (4-liter) Canister – Allows for the collection and containment of fluid waste. The 4-liter canister receives fluid through an installed manifold during collection. The canister contains a fluid level sensor to provide volume information to the top and main displays. The contents of the 4-liter canister may be emptied into the 20-liter canister. High Suction Device WARNING Label (two) -

WARNING HIGH SUCTION DEVICE DO NOT connect directly to chest tubes or other closed wound drains. Failure to comply could result in serious injury or death.

D F

C

B A G

H Figure 8 – Rover Front View A

B

C

Docking Station Interface (not shown) – Provides a sealed flow path for fluid waste transfer from the rover to the docker. Also provides fresh water and detergent transfer from the docker to the rover canisters. Infrared Communication Window – Allows data transfer between the docker and rover during the docking procedure. See Section 19 Glossary for the definition of infrared communication. 20L (20-liter) Canister – Allows for the collection and containment of fluid waste. The 20-liter canister receives fluid through an installed manifold during collection. The canister contains a fluid level sensor to provide volume information to the top and main displays. See Section 8.3.1.3 To Manage a Full Canister. See Section 19 Glossary for the definition of a fluid level sensor.

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I

J

K

Manifold Receptacle (two) – Allows installation of a disposable manifold into the canister. The installation or removal of a valid manifold enables or disables suction, respectively. See Section 19 Glossary for the definitions of a valid and invalid manifold. The receptacle port will close automatically when a manifold is removed. Closure prevents fluid waste leakage from the canister and prevents foreign objects from entering the canister. Suction Range Indicator (two) – Provides colorcoded visual information about the suction limit range. See Table 5 Suction Limit Ranges and Colors. Speaker – Located inside the rover; provides audible event indicators. See Table 11 Audible Event Indicators. Quick Reference Card (QRC) – Allows for quick access to warnings and troubleshooting information. Height Adjustable, Powered IV Pole with Four Hooks – This IV pole is capable of supporting one three-liter [3000 mL] fluid bag per hook. The powered IV pole will return to its lowest position automatically when power is removed from the rover, to ensure proper clearance during relocation. Top Display – Provides visual information of status, as well as safety and alarm indications (Figure 10 and Figure 17). The display swivels in a 360-degree fashion and pivots for ease of viewing from the surgical field or control panel.

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6.1.2 Rover Back View

P

Q

R Q P

S T

U

R

S

O V W X

N

Y

M

T

Z AA U

L AB Figure 9 – Rover Back View L

M

N

O

Vacuum Pump (not shown) – Creates suction for both canisters. If the suction level decreases in either canister due to an open manifold port, the suction level in the other canister may decrease. Fluid Suction Filter Compartment – Allows for the installation and removal of a disposable fluid suction filter. This filter (included) provides HEPA filtration of the air from the 20-liter and 4-liter canisters. See Section 9 Inspection and Maintenance. Canister Viewing Door/Handle (four) – Each canister has two viewing doors with a handle. These doors may be opened during operation to reveal the contents or closed during relocation to conceal the contents. Smoke Evacuator Filter Compartment – Allows for the installation and removal of a disposable smoke evacuator filter (not included) with an ULPA efficiency rating.

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V W

X Y

Z AA

AB

HIGH VACUUM/HIGH FLOW Continuous Surgical Suction Range: 50 - 520 mm-Hg [7 - 69 kPa] – See Section 14 Specifications. Control Panel – Consists of a touch-sensitive main display and two suction control dials. Main Display – Provides the primary operating interface via a touch-sensitive control screen. The display also provides important status information and alarm status (Figure 11 and Figure 13). 4-Liter Suction Control Dial – Allows for the rotary adjustment of the suction LIMIT value of the 4-liter canister; clockwise increases the value and counterclockwise decreases the value. The suction value will appear on the main display as a LIMIT value. See Table 5 Suction Limit Ranges and Colors. 20-Liter Suction Control Dial – Allows for the rotary adjustment of the suction LIMIT value of the 20-liter canister; clockwise increases the value and counterclockwise decreases the value. The suction value will appear on the main display as a LIMIT value. See Table 5 Suction Limit Ranges and Colors. Handle – Allows for relocation and positioning of the rover. Manifold Holder – Allows for the storage of new, unused manifolds. Power Cord Receptacle/Switch – Allows for the connection and application of facility power to the rover. Serial Number Label – Identifies the serial number information of the rover. Specification Label – Identifies the part number information of the rover. See Section 14 Specifications. Power Cord Bracket – Allows for the wrapping and storage of the supplied power cord. Power Cord with Retainer – The supplied power cord is used to connect the rover to facility power. The power cord has a locking feature and must be unlocked prior to disconnection from the rover. The retainer keeps the cord in place. Casters (four) – Four swivel casters provide mobility for the rover to roll across a floor. The two rear casters have locks to prevent unintended movement during operation.

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6.2 Software Interface 6.2.1 Safety Information Screens

WARNING Failure to comply could result in serious injury or death

DO NOT connect directly to chest tubes. DO NOT connect to closed wound drains. Figure 10 – Top Display WARNING Screen

WARNING

002.004.xxx

Failure to comply could result in serious injury or death. DO NOT connect directly to chest tubes.

DO NOT connect directly to tracheal tubes.

DO NOT connect to closed wound drains.

ALWAYS use the minimum suction limit required to achieve the desired clinical outcome.

I have read and understand the safety warnings

Confirm

Figure 11 – Main Display WARNING Screen NOTE: The software version number appears in the upper right corner of the main display WARNING screen. Make sure the number on the screen matches the software version number on the cover of this instructions for use. If not, contact your Stryker sales representative or call Stryker Neptune Customer Service to obtain the latest instructions for use manual. See Section 1.3 Contact Information.

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6.2.2 Menu Structure The main display control screen has a menu structure that provides access to the primary control functions (Figure 12).

IV Pole Evacuate Smoke

Off

Empty 4L Canister

On Power Auto

Reset Volumes

Quick Wash

4L Light

Normal Wash

Settings Docking

Extended Wash Manifolds

Accessories Filters Preferences Languages

Sounds Display Lights

Suction Units Start Suction

Stop Suction

Figure 12 – Control Screen Menu Structure

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6.2.3 Screens, Dialogs, and Drop-downs 6.2.3.1 Main Display Control Screen Areas C

D

E

F

G

H

Suction ON Suction Limit

4L

B Evacuate Smoke Empty 4L Canister Reset Volumes

I

50

used

0 mL since last reset

mm-Hg

Actual:

44

mm-Hg

120

Settings used

Stop Suction

A

200 mL since last reset

mm-Hg

Actual:

HIGH MED LOW

J

OFF

K

20 L HIGH suction

4L Light

MAX

115

mm-Hg

MAX HIGH MED LOW OFF

Figure 13 – Roving Mode (Control) Screen A

B

C

D

E

F

Suction Control Area – Provides a toggle button to control the presence or absence of fluid suction. Control Menu Area – Provides buttons to control the primary functions of the rover (Figure 12). Notification Message Area – Indicates when a low priority alarm condition has occurred (Figure 16); touch to access the drop-down list and/or message. See Section 19 Glossary. Error Message Area – Indicates when a medium priority alarm condition has occurred; touch to access the drop-down list and/or message. See Section 19 Glossary. Canister Information Area (two) – Identifies the specific canister; also provides fluid volume information via a 4L or 20L canister symbol and a fluid volume reading. If the canisters’ volumes are reset, the words ‘since last reset’ will appear. See Table 9 Canister Symbol Colors. Suction Status Area (two) – Indicates the suction status of a canister, including STOPPED, PAUSED, or HIGH.

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G

H

I

J

K

Manifold Indicator Area (two) – Indicates the status of the manifold installed in the receptacle. Status conditions include new or used. See Table 8 Manifold Symbol Colors. Title Area – Indicates status, including system setup, suction ON, suction OFF, EMPTYING 4-liter canister, and PREFILLING 4-liter canister. See Section 19 Glossary for the definition of prefilling. Suction Gauge Area (two) – Indicates the suction selected with the rotary suction control dial, including OFF, LOW, MEDium, HIGH, or MAXimum. See Table 5 Suction Limit Ranges and Colors. Suction LIMIT Value Area (two) – Indicates the selected suction limit value obtained by using the rotary suction control dial. ACTUAL Suction Value Area (two) – Indicates the actual suction value present in the canister. The ACTUAL value may fluctuate and could be significantly lower than the suction LIMIT value.

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6.2.3.2 Typical Settings Dialog Areas D

Accessories

C Filters

B

Manifolds

Fluid Suction HEPA Filter

Reset hours

Time remaining (out of 500)

497 hours

Smoke Evacuation ULPA Filter

E

Reset hours

Time remaining (out of 80)

80 hours A Back

Close

Figure 14 – Accessories Dialog A

B

C

Navigation Area – Provides buttons used to return to the SETTINGS dialog menu or control screen. Options Area – Provides options that may be adjusted, as well as default settings information or life-cycle use information. Tab Selection Area – Provides selection tabs, including FILTERS, MANIFOLDS, SOUNDS, DISPLAYS, and LIGHTS.

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D

E

Title Area – Indicates the name of the settings dialog, including DOCKING, ACCESSORIES, and PREFERENCES. Option Adjustment Area(s) – Provides buttons used to adjust sound or brightness, reset hours, or select default settings. Also displays the number of manifolds used within the last 30 days and 90 days.

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6.2.3.3 Typical Docking Mode Screen Areas C

D

E

Docking Mode B

Quick Wash

F

Normal Wash Extended Wash

Select an option from the left-hand menu

A

G Normal Wash cycle will start automatically in 2

Cancel

Figure 15 – Docking Mode Screen A

B

C

D

Cycle Control Area – Allows for most control over cycle activity, including: ABORT TO QUICK WASH, CANCEL, and RELEASE FROM DOCKer after cycle completion. For additional cycle control information, see Section 8.4.3.2 To Perform a Docking Cycle. Cycle Options Menu – Allows for the manual selection of a cycle. Manual selection will override the default cycle setting. Notification Message Area – Indicates when a low priority alarm condition has occurred (Figure 16); touch to access the drop-down list and/or message. Error Message Area – Indicates when a medium priority alarm condition has occurred; touch to access the drop-down list and/or message.

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E F

G

Title Area – Indicates the name of the screen. Status Area – Provides instruction, identifies the type of cycle selected, and indicates the cycle status. Default Cycle Message Area – Indicates when the default cycle will begin after the rover is connected to the docker. A selection from the cycle options menu may be made to override the default setting.

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