Neptune 2 Instructions for Use Rev D May 2016

WARNING: HIGH SUCTION DEVICE Only trained and experienced healthcare professionals may use this equipment. DO NOT connect directly to chest tubes.

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

DO NOT connect to closed wound drains.

NOT FOR USE as a suction source for organ stabilizer/ positioner or patient positioner devices.

DO NOT connect directly to tracheal tubes.

NOT FOR USE as a suction source for intermittent suction applications.

FAILURE TO COMPLY COULD RESULT IN SERIOUS INJURY OR DEATH. DO NOT remove any safety card from the equipment. For more information, including safety information, or in-service training, contact your Stryker sales representative. Outside the US, contact your nearest Stryker subsidiary.

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Known Use Errors It is important to acknowledge and be aware of potential hazards associated with the Neptune 2 Waste Management System prior to use. This information highlights known use errors that constitute improper and unsafe use of the Neptune 2 system. Stryker has received incident reports of serious injury and/or death associated with operating the Neptune 2 Rover. Stryker has received reports that the Neptune 2 Rover had been connected directly to a chest tube, postoperatively, which resulted in fatalities.

Direct connection to chest tube that led to patient death. Stryker has received reports that the Neptune 2 Rover had been connected to a patient’s closed wound drain, postoperatively, which resulted in serious patient injury.

Connection to closed wound drain that led to serious patient injury.

For training information, visit www.neptunecustomercare.com. Print Date: Jul 06, 2016 09:06:22 AM 0000085852, Rev. D Effective Date: Jul 6, 2016 8:05:45 AM

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0702-230-700 Rev-D

Contents Introduction ... 6 Conventions ... 6 Contact Information ... 6 Indications For Use ... 6 Contraindications ... 6 For Use With ... 6 Accessories... 6 System Overview ... 7 User/Patient Safety ... 8 General ... 8 Low Suction ... 8 High Suction... 8 Electrical Safety ... 8 Environmental/Biological ... 9 Features ... 10 Rover Front View ... 10 Rover Back View ... 11 Control Panel ... 12 Control Panel Display Screens ... 13 Definitions ... 14 Control Panel Button Screen Icons ... 14 Symbols ... 14 Suction Limit Setting Dial Colors ... 15 Fluid Level Display Screen Messages ... 15 Audible Event Indicators... 15 Instructions ... 16 Before First Use... 16 To Unpack the Rover ... 16 To Initially Dock the Rover ... 16 To Test the Rover ... 16 1. To Connect Power... 16 2. To Test Fluid Suction... 16 3. To Test the IV Pole ... 16 4. To Test Smoke Evacuation ... 17 To Adjust the Rover Settings ... 17 Before the Procedure ... 18 To Setup the Rover ... 18 1. To Connect Power... 19 2. To Prepare For Fluid Suction ... 19 3. To Prepare For Smoke Evacuation ... 20 4. To Use the IV Pole... 20 During the Procedure ... 20 To Operate the Rover ... 20 1. To Control Fluid Suction ... 21 2. To Control Smoke Evacuation ... 21 3. To Adjust the IV Pole ... 22 4. To Manage Full Canisters ... 22

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After the Procedure ... 23 To Shutdown the Rover... 23 1. To Remove Fluid Suction Components ... 23 2. To Remove Smoke Evacuation Components ... 24 3. To Remove IV Pole Components ... 24 4. To Remove Power... 25 5. To Prepare for Relocation ... 25 6. To Relocate the Rover ... 25 To Dock the Rover ... 26 1. To Prepare the Docker... 26 2. To Perform a Wash Cycle ... 26 Inspection and Maintenance ... 28 Cleaning ... 29 Storage and Handling ... 29 Disposal/Recycle ... 29 Troubleshooting... 30 Rover Operation ... 30 Docking Station Operation ... 32 Error Code Messages... 33 Specifications ... 34 Appendix ... 39 To Use Auxiliary Suction Ports (optional)... 39

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Introduction

For Use With

This Instructions For Use manual is the most comprehensive source of information for your product. Keep and consult this reference manual during the life of the product.

The following components are required to be used with the equipment described in this manual to create a complete system: DESCRIPTION

REF

Conventions

Neptune Docking Detergent (2/pack)

0700-001-026

The following conventions are used in this manual:

Neptune 2 Docking Station (docker)

0702-015-000 (230 VAC)

Neptune 2 Manifold(s)

See Accessories section.

Fluid Suction HEPA Filter (1 each)

0702-034-000

Smoke Evacuator ULPA Filter (4/pack)

0702-040-000

WARNING

A warning highlights a safety-related issue. ALWAYS comply with this information to prevent patient or healthcare staff injury.

CAUTION

A caution highlights a product reliability issue. ALWAYS comply with this information to prevent product damage.

NOTE

A note supplements and/or clarifies procedural information.

Contact Information For additional information, including safety information, or in-service training, contact your Stryker sales representative. Outside the United States (US), contact your nearest Stryker subsidiary.

NOTE: Suction tubing and other accessories are also required for a complete system. These components may not be sold by Stryker. See the Contact Information section for more information.

Accessories This section describes system components that may be ordered to replace original equipment that is damaged, worn, or must be replaced. This section may also contain optional components used with the system.

Indications For Use

The following Stryker-approved accessories are sold separately:

The Neptune 2 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.

DESCRIPTION

REF

Neptune Docking Detergent (2/pack)

0700-001-026

Neptune 2 4-Port Manifold (20/pack)

0702-020-000

Neptune 2 Specimen Collection 4-Port Manifold (20/pack)

0702-020-001

Neptune 2 Single-Port Manifold (20/pack)

0702-025-000

Contraindications

Fluid Suction HEPA Filter (1 each)

0702-034-000

Smoke Evacuator ULPA Filter (4/pack)

0702-040-000

The Neptune 2 Waste Management System is contraindicated against:

Smoke (Evacuator)Tubing, 3/8 inch x 10 feet (10/pack)

0702-045-023

Smoke (Evacuator) Tubing, 7/8 inch x 10 feet (10/pack)

0700-026-000

Global Power Cord

6000-115-162

▪

Connection directly to chest tubes.

▪

Connection to closed wound drainage systems.

NOTE: For a complete list of accessory information, contact your Stryker sales representative or call your nearest Stryker subsidiary. Trademarks not the property of Stryker Corporation are the property of their respective owners.

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System Overview The Stryker Rover (rover) is a mobile unit used to suction and collect fluid waste and evacuate surgical smoke from a surgical site in an operating room. The rover also has a height-adjustable, powered IV pole.

After collection, the rover is relocated and mated 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).

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 settings and fluid volume measurement capability. However, both canisters use a single vacuum pump. The vacuum pump exhaust is filtered.

Figure 3 To Empty the Canisters The rover canister(s) 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 1 To Collect Fluid Waste 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 2).

Figure 4 To Clean the Canisters

Figure 2 To Evacuate Surgical Smoke

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User/Patient Safety

High Suction ▪

HIGH SUCTION DEVICE - 480 mm-Hg [64 kPa] (maximum)

WARNINGS:

General ▪

Before using any system component, or any component compatible with this system, read and understand the instructions. Pay particular attention to WARNING information. Become familiar with the system components prior to use.

▪

Only trained and experienced healthcare professionals may use this equipment.

▪

Healthcare professionals should be thoroughly familiar with the instructions for use, handling characteristics, and the indicated and intended uses of this equipment. Contact your Stryker sales representative for in-service training. See the Contact Information section. 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.

▪

DO NOT disassemble, modify, service, or repair any system component or accessory, unless otherwise specified.

The effectiveness of aspiration is dependent upon the intensity of the vacuum applied.

▪

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

▪

ALWAYS follow your institution’s guidelines for suction limits.

▪

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.

Death or serious injury can result from improper suction levels. ▪

▪

▪

The suction limit setting may only be adjusted by the SUCTION LIMIT SETTING dial on the control panel. Interruption and restoration of rover power, whether accidental or intentional, does not reset the suction limit setting to zero. See ISO 10079-1: 1999, clause 13.8. Use caution when activating suction with a high suction limit setting.

Electrical Safety

▪

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 the Inspection and Maintenance section for inspection criteria.

▪

Use only Stryker-approved system components and accessories, unless otherwise specified. Using other electronic components and accessories may result in increased electromagnetic emissions or decreased electromagnetic immunity of the system.

▪

ALWAYS operate the equipment within the specified environmental condition values. See the Specifications section.

▪

▪

The canister scale and fluid volume display are not diagnostic tools. DO NOT use the scale or fluid volume display to determine the amount of fluid lost from or retained by the patient.

Take special precautions regarding electromagnetic compatibility (EMC) when using medical electrical equipment like this system. Install and place this system into service according to the EMC information contained in this manual. See the Specifications section. Portable and mobile radio frequency (RF) communications equipment can affect the function of this system.

▪

DO NOT cover the device control panel with drapes or other objects. Make sure the control panel can be clearly seen.

▪

ELECTRICAL SHOCK HAZARD

▪

TIPPING HAZARD - DO NOT lean on the rover.

Low Suction ▪

LOW SUCTION HAZARD NOT FOR USE as a suction source for the following applications: ▪

Organ stabilizer/positioner devices

▪

Patient positioner devices

▪

ALWAYS connect this equipment to a hospital-grade, 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.

Death or serious injury can result from fluctuating suction levels.

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User/Patient Safety WARNINGS:

WARNINGS: ▪

The manifold is for SINGLE PATIENT USE ONLY. DO NOT sterilize or reuse. DO NOT reuse, reprocess, or repackage a single use device. A single use device is intended for a single use only. 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 serious risk of contamination and may compromise the structural integrity of the device resulting in operational failure. Critical product information may be lost if the device is repackaged. Failure to comply may lead to infection or cross-infection and result in patient or healthcare staff injury.

▪

ALWAYS make sure rover power is ON when collecting fluid waste. The rover can only detect full canisters if the rover is ON. If the rover is OFF, biohazard waste leakage or loss of suction can occur.

Environmental/Biological ▪

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.

▪

BLOODBORNE PATHOGEN HAZARD ▪

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

ALWAYS clean the equipment as indicated upon initial receipt and before each use. DO NOT place the rover within the sterile field. Failure to comply may cause infection and result in patient or 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 Disposal/Recycle section.

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

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Features

D

High Suction Device WARNING Label (two) –

WARNING

Rover Front View (Figure 5) G

H

F

I

E

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. Refer to instruction manual/booklet for important safety information.

E

Manifold Port (two) – Allows installation of a disposable manifold into the canister. The port will close automatically when a manifold is removed. Closure prevents fluid leakage during transport and docking and prevents foreign objects from entering the canister.

F

Speaker – Located inside the rover, provides audible event indicators. See the Audible Event Indicators table.

D

C

G Tipping Hazard WARNING Label –

WARNING

B

TIPPING HAZARD DO NOT lean on rover.

A

J

K

Figure 5 Rover Front View

A

Infrared Communication Window – Allows data transfer between the docker and rover. Data transfer is necessary during the docking procedure.

B

20L (20-liter) Canister – Allows for the collection and containment of liquids. The 20-liter canister receives fluid through an installed manifold during the collection of fluid waste. The canister contains a fluid level sensor to provide input to the fluid level display.

C

4L (4-liter) Canister – Allows for the collection and containment of liquids. The 4-liter canister receives fluid through an installed manifold during the collection of fluid waste. The canister contains a fluid level sensor to provide input to the fluid level display. The contents of the 4-liter canister may be emptied into the 20-liter canister. See the To Manage Full Canisters section.

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H

Powered IV Pole – This motor-powered IV pole is capable of holding four three-liter [3000 mL] IV bags, one bag per hook. The IV pole will return to its lowest position automatically when power is removed from the rover to ensure proper clearance during relocation.

I

Fluid Level Display – Provides a visual display of the fluid volume values of each canister. The display swivels in a 360-degree fashion and pivots for ease of viewing. The units of measurement may be changed to liters [L], cubic centimeters [cc], or milliliters [mL]. Display brightness may also be adjusted. See the To Adjust the Rover Settings section.

J

Canister Access Door/Knob (two) – Each canister has access doors with knobs. These doors may be opened during operation to reveal the contents or closed during relocation to conceal the contents.

K

Casters (four) – Four swivel casters allow the rover its mobility. The two rear casters have locks to prevent inadvertent movement during operation.

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Features

R

Suction Chart and WARNINGS Label – HIGH VACUUM / HIGH FLOW Continuous Surgical Suction Range: 50 to 480 mm-Hg / 7.0 to 64.0 kPa

Rover Back View (Figure 6)

480

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

P

kPa

120

mm-Hg

kPa

MED 80

mm-Hg

0

kPa

‡ Intermittent suction applications DEATH or serious injury can result.

7.0 OFF

kPa

0

Suction Limit Setting

0702-002-703 Rev-

S

Quick Reference Cards – Allows for quick access to specific system information, warnings, and troubleshooting information.

T

Manifold Holder – Allows for the storage of new, unused manifolds.

U

Auxiliary Suction Ports (optional) – Allow connection to a hospital wall suction regulator if an alternate suction source is required. See the Appendix, To Use Auxiliary Suction Ports (optional) section.

V

High Suction Hazard WARNING Label –

R S T

U

‡ Organ stabilizer/positioner devices ‡ Patient positioner devices

10.5

mm-Hg

NOT FOR USE as a suction source for the following applications:

LOW

Q

N

WARNING 16.0

50

O

64.0

HIGH

ALWAYS follow your institution’s guidelines for suction limits. DEATH or serious injury can result from improper suction levels.

MAX

mm-Hg

V

WARNING HIGH SUCTION HAZARD

W M

X Y

ALWAYS use hospital wall suction regulator to control and monitor suction levels when using auxiliary suction ports.

Z

L

Failure to comply could result in serious injury or death.

Figure 6 Rover Back View

L

Single Vacuum Pump (not shown) – Creates suction for both canisters. If the suction level decreases in either canister, due to an open port, the suction level in the other canister may decrease.

W Auxiliary Suction Ports Label – AUXILIARY SUCTION PORTS (Connect to hospital wall suction regulator)

M Fluid Suction HEPA Filter Compartment – Allows for the

N

installation and removal of a disposable fluid suction filter. This filter (included) provides High Efficiency Particulate Air (HEPA) filtration of the air from the 20-liter and 4-liter canisters. See the Inspection and Maintenance section.

X

Power Cord Receptacle/Switch – Connect facility power to the receptacle using the rover power cord. Push the toggle switch to apply or remove facility power. See the Definitions section for ON and OFF power symbol definitions.

Smoke Evacuator ULPA Filter Compartment – Allows for the installation and removal of a disposable smoke evacuator filter (not included) with an Ultra Low Penetrating Air (ULPA) efficiency rating.

Y

Power Cord Bracket/Cord – Store the power cord on the bracket. Use the power cord to connect the rover to facility power.

Z

Specification Label –

O Handle – Allows for relocation and positioning of the rover. P WARNING Flag – Allows for quick access to specific HIGH SUCTION DEVICE WARNING information.

Q Control Panel – Allows the operation of the rover using dials and push buttons. The panel also provides visual feedback through a control panel display. See the Features, Control Panel section.

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Features Control Panel (Figure 7) E

F

G

H

I

D

J

C

K

B

A

O

N

M

L

Figure 7 Control Panel

A

Evacuate Smoke Button – Push the button to start or stop smoke evacuation. See the Smoke Evacuator Modes of Operation table for options.

B

Evacuate Smoke Indicator – Illuminates when smoke evacuator is activated.

C

4L (4-liter) Suction Limit Setting Dial – Turn the dial to adjust the suction limit of the 4-liter canister. The suction value will be indicated on the control panel display as a limit SETTING value or an ACTUAL value. See the Features, Control Panel Display Screens section and the Definitions, Suction Limit Setting Dial Colors table.

D

Suction Limit Setting Ranges – See the Definitions, Suction Limit Setting Dial Colors table section for codes and suction limit range information before adjusting the SUCTION LIMIT SETTING dials.

E

Control Panel Display Push Buttons (four) – Push the appropriate button to interact with the display.

F

Control Panel Display – Provides suction values for each canister, system status and error code messages; also displays wash cycle options during the docking procedure. Display brightness and contrast may also be adjusted. See the To Adjust the Rover Settings section.

G HIGH VACUUM / HIGH FLOW Continuous Surgical Suction Range: 50 to 480 mm-Hg [6.7 to 64 kPa] – See the Specifications section. 12 Print Date: Jul 06, 2016 09:06:22 AM 0000085852, Rev. D Effective Date: Jul 6, 2016 8:05:45 AM

H

System Setup Button – Push and hold the button until the SYSTEM SETUP screen appears with options.

I

IV Pole Buttons – Push and hold the UP or DOWN arrow button to raise or lower the height of the IV pole, respectively.

J

System Setup Symbol – Push and hold the push button next to this symbol to access the SYSTEM SETUP screen and change rover settings. See the To Adjust the Rover Settings section.

K

20L (20-liter) Suction Limit Setting Dial – Turn the dial to adjust the suction limit of the 20-liter canister. The suction value will be indicated on the control panel display as a limit SETTING value or an ACTUAL value. See the Features, Control Panel Display Screens section and the Definitions, Suction Limit Setting Dial Color section.

L

Empty 4L Canister Button – Push the button to transfer the contents of the 4-liter canister into the 20-liter canister. Transfer requires confirmation.

M Suction ON/OFF Button – Push the button to start or stop fluid suction.

N

Suction ON/OFF Indicator – Illuminates when fluid suction is activated.

O Reset Volume Button – Push the button to reset the fluid display level of both canisters to zero values. Reset requires confirmation.

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Features

A

Smoke Evacuation Information Area – The area includes the power setting during operation and the mode of operation. See the Smoke Evacuator Modes of Operation table for details.

B

Canister Identification Area – The 4-liter canister information is on the top half of the display. The 20-liter canister information is on the bottom half of the display.

C

Suction Level Value Areas – Each area provides the suction level value for the corresponding canister. If the suction supplied through the auxiliary suction ports exceeds the value of 570 mm-Hg [76 kPa], the control panel display will no longer indicate a value, but will show dash marks [---].

D

Suction Level Unit of Measure Areas – Each area provides the suction value units of measure for the corresponding canister.

E

Suction Limit Range Indicator Areas – Each area indicates whether the suction limit value is in the HIGH, MED(ium) or LOW range for the corresponding canister. See the Definitions, Suction Limit Setting Dial Color section for suction limit range information.

F

Suction Information Type Area – These areas indicate the type of suction information being displayed for each canister:

Control Panel Display Screens (Figures 8 and 9) B

C

A SMOKE 20% AUTO

D

60 105

mm-Hg LOW

SETTING

E

mm-Hg MED

ACTUAL

F Figure 8 CONTROL Screen

SETTING indicates the displayed value is the suction limit SETTING selected by the user. It is shown whenever the corresponding setting dial is adjusted, and persists for 5 seconds after adjustment is complete.

G

SYSTEM SETUP VOLUME DISPLAY UNITS VOLUME DISPLAY BRIGHT FLUID AUDIBLE INDICATORS VACUUM DISPLAY BRIGHT VACUUM DISPLAY CONTRAST

H ACTUAL indicates the displayed value is the current suction level actually present in the canister. The ACTUAL value is displayed whenever the suction limit SETTING is not being adjusted. The ACTUAL value may fluctuate and could be significantly lower than the SETTING value.

OK I

ESC

G Title Area – The area indicates the type of screen displayed, including menu or message screens.

H

Push Button Label Areas – Four areas that correspond to the adjacent control panel display push buttons and indicate the button’s function. See the Definitions, Control Panel Button Screen Icons table.

I

Message Area – The area displays system setup options, wash cycle options, warnings, and error message information.

Figure 9 MENU/MESSAGE Screen Example

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Definitions

Symbols

Control Panel Button Screen Icons

The symbols located on the equipment and/or labeling are defined in this section or in the Symbol Definition Chart. See the Symbol Definition Chart supplied with the equipment.

LABEL / ICON

NAME

DEFINITION

DOWN/DECREASE

Scroll down to highlight an option or decrease a value.

UP/INCREASE

Scroll up to highlight an option or increase a value.

SYMBOL

DEFINITION ON (POWER) OFF (POWER) SUCTION ON/OFF

ERROR INDICATOR

Access ERRORS screen to view error(s). See the Error Code Messages section.

4-LITER (4L) CANISTER 20-LITER (20L) CANISTER

ESC

OK

Close or ESCape a screen without accepting changes or selections and return to previous screen. Accept changes and return to the previous screen. Select an error message and access message screen.

RESET VOLUME EMPTY 4L CANISTER IV POLE HEIGHT ADJUSTMENT

RESET

RESET the timer value when either the fluid suction filter or the smoke evacuator filter is replaced.

EVACUATE SMOKE

SELECT MARK

Icon indicates screen option is selected and applied.

SUCTION LIMIT SETTING

CONSULT INSTRUCTIONS FOR USE

Icon indicates the need to consult instructions for use, specifically error message information.

SYSTEM SETUP

CONSULT INSTRUCTIONS FOR USE

REFER TO INSTRUCTION MANUAL/ BOOKLET GENERAL WARNING SIGN

ALTERNATING CURRENT (AC) DIRECT CURRENT (DC) TYPE CF APPLIED PART

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SYMBOL

Fluid Level Display Screen Messages

DEFINITION PROTECTIVE EARTH (GROUND)

MESSAGE

DEFINITION

FULL

Indicates a canister is full (Figure 10). See the Fluid Volume Indicators table.

Error

Indicates a serious error has occurred. See the control panel display for the specific error message and the Error Code Messages section.

-----

Dashes indicate the value of the volume is in transition or an error has occurred. The system may still be used.

MANIFOLD PORT

FLUID SUCTION FILTER COMPARTMENT

SMOKE FILTER COMPARTMENT

FULL FULL

mL

mL

AUXILIARY SUCTION PORTS

Figure 10 Fluid Level Display

Audible Event Indicators Suction Limit Setting Dial Colors NOTE: Each color is associated with a suction range as shown in the suction chart located below the control panel. See the Features section for more information. COLOR

SUCTION LIMIT

RANGE

INCREMENTS

MAX(IMUM)

480 mm-Hg [64 kPa]

Not Applicable

Orange –

HIGH

120 to 480 mm-Hg [16 to 64 kPa]

20 mm-Hg [2.7 kPa]

Yellow –

MED(IUM)

80 to 115 mm-Hg [10.7 to 15.3 kPa]

5 mm-Hg [0.7 kPa]

Green –

LOW

50 to 75 mm-Hg [6.7 to 10 kPa]

5 mm-Hg [0.7 kPa]

White –

OFF

0 mm-Hg [0 kPa]

Not Applicable

This table describes the audible indicators associated with each type of system event. TYPE

INDICATION

EXAMPLE

Button Actuation

One short beep

EMPTY 4L CANISTER button is pushed; EMPTY 4L CANISTER is started. RESET VOLUME button is pushed.

Task Completion

Three short beeps

Docking cycle is complete. 4-liter canister has been emptied into the 20-liter canister.

General Notification

One long beep

Message or error information appears on control panel display screen. See the Error Code Messages section.

Lost Functionality

Two long beeps

Message or error information appears on control panel display screen. See the Error Code Messages section.

NOTE: For additional indicators, see the High Suction Indicator section and the Fluid Volume Indicators section.

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c. Read the WARNING message on the control panel display, then push the control panel display button next to OK to access the CONTROL screen (Figure 12).

Instructions Before First Use

WARNING

To Unpack the Rover

OK

1c

HIGH SUCTION DEVICE DO NOT CONNECT DIRECTLY TO CHEST TUBES OR OTHER CLOSED WOUND DRAINS

WARNING: HEAVY EQUIPMENT - ALWAYS have more than one person unpack and move this equipment from the shipping pallet. See the Specifications section for rover weight. Failure to comply may result in personal injury. 1. Remove the exterior packaging materials from the rover and recycle the material as required. 2. Using at least two people, remove the rover from the shipping pallet.

Figure 12 High Suction Device Warning

2. To Test Fluid Suction a. Push the SUCTION button to start the vacuum pump (Figure 13). Make sure the vacuum pump starts. If not, see the Troubleshooting section and the Error Code Messages section.

230 VAC ULTRA Rover

0702-002-000

Global Power Cord

6000-115-162

b. Adjust the SUCTION LIMIT SETTING dial of the canister to be tested to the maximum suction level. Make sure the value displayed on the control panel changes and reaches a maximum suction level between 475 and 480 mm-Hg [63.3 and 64 kPa]. If not, see the Troubleshooting section and the Error Code Messages section.

Instructions for Use (IFU)

0702-230-700

c. Repeat step b to test the other canister.

Neptune 2 Docking Station Instruction Poster

9100-001-179

3. Inspect the rover and components for damage. If damage is apparent, DO NOT use the equipment. COMPONENTS

REF

To Initially Dock the Rover NOTE: Initial docking of the rover is required to replace the transport fluid in the canisters with prefill fluid. Failure to comply will result in prefill errors and prevent the rover from operating properly. See the To Dock the Rover section to perform initial docking of the rover.

2b

2c

To Test the Rover 2a

1. To Connect Power a. Connect the rover to facility electrical power using the power cord. Insert the plug of the power cord through the strain relief hole before connecting the cord to the rover (Figure 11).

Figure 13 To Test Fluid Suction

3. To Test the IV Pole

b. Push the power switch to the ON position.

1b

Push the UP and DOWN ARROW buttons to raise and lower the IV pole (Figure 14). Make sure the IV pole functions correctly. If not, see the Troubleshooting section and the Error Code Messages section.

1a 3

Figure 11 Power Cord Strain Relief Figure 14 To Test IV Pole 16 Print Date: Jul 06, 2016 09:06:22 AM 0000085852, Rev. D Effective Date: Jul 6, 2016 8:05:45 AM

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0702-230-700 Rev-D

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4. To Test Smoke Evacuation

To Adjust the Rover Settings

NOTES:

1. Make sure the power cord is connected between the rover and facility power.

▪

▪

Make sure a smoke evacuator filter is installed in the rover before testing smoke evacuation. See the Accessories section. See the instructions for use supplied with the smoke evacuator filter for installation information. The rover tracks the life expectancy of the smoke evacuator filter. DO NOT relocate the smoke evacuator filter after initial installation into the rover.

2. Make sure the power switch is in the ON position and the HIGH SUCTION DEVICE WARNING has been acknowledged. 3. From the control panel, push and hold the push button until the SYSTEM SETUP screen appears (Figure 17).

a. Push the EVACUATE SMOKE button (Figure 15).

4a

Figure 15 To Test Smoke Evacuation

Figure 17 To Access System Setup

b. From the control panel display, push the buttons next to the arrow icons to adjust the smoke evacuator power (Figure 16). Make sure the smoke evacuation functions correctly. If not, see the Troubleshooting section and the Error Code Messages section.

4. From the SYSTEM SETUP screen, push the buttons next to the arrow icons to highlight the appropriate system setting. Push the button next to OK to view the desired system setting screen (Figure 18). SYSTEM SETUP

SMOKE 20% AUTO

4b

VOLUME DISPLAY UNITS VOLUME DISPLAY BRIGHT FLUID AUDIBLE INDICATORS VACUUM DISPLAY BRIGHT VACUUM DISPLAY CONTRAST SMOKE FILTER LIFE SUCTION FILTER LIFE ERROR HISTORY

OK

ESC

Figure 18 System Setup Screen Figure 16 To Adjust Smoke Evacuation NOTE: See the To Adjust the Rover Settings section to make setting changes as required.

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0702-230-700 Rev-D

To Adjust the Rover Settings (continued)

System Setup Options (continued)

5. From a SYSTEM SETTING screen, push the buttons next to the arrow icons to highlight or adjust the appropriate setting option. See the System Setup Options table for available setting options.

MAINTENANCE SMOKE FILTER LIFE SUCTION FILTER LIFE

6. Push the button next to the OK icon to select the appropriate system setting option (Figure 19). Push the button next to the ESC icon to cancel the selection and exit the screen.

ERROR HISTORY VOLUME DISP UNITS mL L cc

OK

OPTIONS

FACTORY DEFAULT

Reset timer to accept

80 hours

Reset timer to accept

500 hours

See the Error Code Messages section.

Not Applicable

NOTE: After adjusting the rover system settings, disconnect the rover from facility power and wrap the power cord around the power cord bracket. The rover is now ready to be used in an operating room setting.

ESC

Before the Procedure Figure 19 Sample System Setting Screen NOTE: To reset the smoke evacuator filter timer or fluid suction filter timer, see the instructions for use supplied with the filter for more information.

System Setup Options FLUID LEVEL DISPLAY

OPTIONS

FACTORY DEFAULT

VOLUME DISPLAY UNITS

mL [milliliter] L [liter] cc [cubic centimeter]

mL

VOLUME DISPLAY BRIGHTness

0 - 100%

75%

FLUID AUDIBLE INDICATORS

4L canister 20L canister

0 - 2000 mL 0 - 10,000 mL

600 mL (remaining capacity) 2000 mL (remaining capacity)

CONTROL PANEL DISPLAY

OPTIONS

FACTORY DEFAULT

VACUUM DISPLAY UNITS

mm-Hg [millimeters of mercury] kPa [kilopascals]

mm-Hg

0 - 100%

75%

0 - 100%

70%

English Spanish [Español] French [Français] German [Deutsch] Italian [Italiano] Dutch [Nederlands] Finnish [Suomi] Danish [Dansk]

English

VACUUM DISPLAY BRIGHTness VACUUM DISPLAY CONTRAST

LANGUAGE

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To Setup the Rover WARNINGS: ▪

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 the Inspection and Maintenance section for inspection criteria. DO NOT use the rover until it has been tested properly to ensure functionality. See the To Test the Rover section.

▪

ALWAYS clean the equipment as indicated upon initial receipt and before each use. DO NOT place the rover within the sterile field. Failure to comply may cause infection and result in patient or healthcare staff injury.

CAUTION: DO NOT clamp or attach any accessory onto the pole or base of the powered IV pole assembly. NOTES: ▪

DO NOT use the rover until the docker has been installed and tested properly to ensure functionality. See the instructions for use supplied with the docker.

▪

The volume of the initial prefill fluid in the canister(s) is accounted for in the fluid level value indicated on the fluid level display. Foam does not affect this fluid level value.

▪

ALWAYS close unused manifold ports, and remove or clamp unused tubing to maintain optimal suction levels. The suction level in each canister is degraded by the suction demand on the other canister.

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1. To Connect Power (Figure 20)

2. To Prepare For Fluid Suction (Figure 22)

a. Position the rover on a flat surface and in a convenient location within the operating room.

NOTE: The fluid suction tubing and suction accessory are applied parts.

b. Lock the rover’s two rear casters to prevent rover movement.

a. Install new disposable manifold(s) into the manifold port(s). Make sure the manifold(s) are fully twisted and locked into place. See the instructions for use supplied with the manifold for more information.

c. Orient the rover’s fluid level display for optimal viewing. d. Open the canister access doors from each side of the rover to allow viewing of the contents. CAUTION: ALWAYS use the correct power cord. Configurations may vary. e. Connect the rover to facility electrical power using the appropriate power cord. f. Push the power switch to the ON position. g. Read the WARNING message on the control panel display, then push the control panel display button next to OK to access the CONTROL screen (Figure 21).

b. Attach the fluid suction tubing to the port(s) of the installed manifold(s). ALWAYS close unused manifold ports. c. Attach a fluid suction accessory to the end of the suction tubing if required. d. Push the RESET VOLUME button to reset the fluid display level value to zero if required. e. If the RESET VOLUME button is pushed, a confirmation screen will appear. Push the control panel display button next to OK to reset the volume levels to zero (Figure 23).

NOTE: If the 4-liter or 20-liter suction limit setting dial is positioned in the high suction range, the rover will provide an audible and visual indication of this condition. See the High Suction Indicator section.

2d

2a

1c

1f

2b

1e 1d 2c

1b

1a

Figure 22 To Prepare for Fluid Suction

NOTE

Figure 20 To Connect Power

WARNING

PRESSING OK WILL RESET BOTH VOLUME LEVELS TO ZERO

OK

HIGH SUCTION DEVICE DO NOT CONNECT DIRECTLY TO CHEST TUBES OR OTHER CLOSED WOUND DRAINS

OK

2e ESC

1g Figure 23 To Reset Volume Level to Zero

Figure 21 High Suction Device Warning

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0702-230-700 Rev-D

To Setup the Rover (continued)

During the Procedure

3. To Prepare For Smoke Evacuation (Figure 24)

To Operate the Rover

NOTES: ▪

▪

Make sure a smoke evacuator filter is installed in the rover before using smoke evacuation. See the Accessories section. See the instructions for use supplied with the smoke evacuator filter for installation information.

WARNINGS: ▪

The smoke evacuator tubing and optional smoke evacuator attachment are applied parts.

a. Install the smoke evacuator tubing to the smoke evacuator filter. b. Install a smoke evacuator attachment to the end of the smoke tubing, if required.

3a

HIGH SUCTION DEVICE - 480 mm-Hg [64 kPa] (maximum) ▪

The effectiveness of aspiration is dependent upon the intensity of the vacuum applied.

▪

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

▪

ALWAYS follow your institution’s guidelines for suction limits.

▪

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.

Death or serious injury can result from improper suction levels. ▪

The canister scale and fluid volume display are not diagnostic tools. DO NOT use the scale or fluid volume display to determine the amount of fluid lost from or retained by the patient.

▪

ALWAYS make sure rover power is ON when collecting fluid waste. The rover can only detect full canisters if the rover is ON. If the rover is OFF, biohazard waste leakage or loss of suction can occur.

▪

The suction limit setting may only be adjusted by the SUCTION LIMIT SETTING dial on the control panel. Interruption and restoration of rover power, whether accidental or intentional, does not reset the suction limit setting to zero. See ISO 10079-1: 1999, clause 13.8. Use caution when activating suction with a high suction limit setting.

▪

LOW SUCTION HAZARD

3b

Figure 24 To Prepare for Smoke Evacuation

4. To Use the IV Pole (Figure 25) NOTE: The IV pole will return to its lowest position automatically when power is removed from the rover. a. Hang one irrigation bag on each IV pole hook, if required. The maximum volume allowed per hook is 3000 milliliters. b. Push and hold the IV pole UP ARROW button to raise the IV pole to the desired height.

NOT FOR USE as a suction source for the following applications: ▪

Organ stabilizer/positioner devices

▪

Patient positioner devices

Death or serious injury can result from fluctuating suction levels.

4b 4a

Figure 25 To Use the IV Pole

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