Stryker 0702-001-000 Instructions For Use Manual Download Page 9

8

www.stryker.com

EN

0702-002-700 Rev-S

User/Patient Safety

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 or Stryker Neptune Customer Service 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. Call Stryker 
Neptune Customer Service. See the 

Contact Information

 section.

 

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. 

 

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.

 

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

 

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

Death or serious injury can result from fluctuating suction levels.

High Suction

 

HIGH SUCTION DEVICE [MAX = 480 mm-Hg]

 

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

 

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.

 

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.

 

ELECTRICAL SHOCK HAZARD

 

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.

0000016914, Rev. S Effective Date: Mar 11, 2016 9:46:10 AM

Printed Date: Feb 24, 2020 18:26:59 GMT

Summary of Contents for 0702-001-000

Page 1: ...abels or IFUs Description Type Stryker Instruments 269 323 7700 800 253 3210 Print Location Suppliers Services Part Number Rev 8 5 inch width x 11 inch Booklet Print Center Color Graphics on White Bac...

Page 2: ...w stryker com Instructions For Use ENGLISH EN Neptune 2 Waste Management System 120 VAC ULTRA Rover 0702 001 000 Software Version 4 1 x 0000016914 Rev S Effective Date Mar 11 2016 9 46 10 AM Printed D...

Page 3: ...URE TO COMPLY COULD RESULT IN SERIOUS INJURY OR DEATH NOT FOR USE as a suction source for organ stabilizer positioner or patient positioner devices NOT FOR USE as a suction source for intermittent suc...

Page 4: ...r 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 For t...

Page 5: ...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 Suct...

Page 6: ...on 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 Trou...

Page 7: ...ystem DESCRIPTION REF Neptune Docking Detergent 2 pack 0700 001 026 Neptune 2 Docking Station docker 0702 014 000 120 VAC Neptune 2 Manifold s See Accessories section Fluid Suction HEPA Filter 1 each...

Page 8: ...vacuum pump exhaust is filtered 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 th...

Page 9: ...e for the following applications Organ stabilizer positioner devices Patient positioner devices Death or serious injury can result from fluctuating suction levels High Suction HIGH SUCTION DEVICE MAX...

Page 10: ...lure 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 agen...

Page 11: ...osable 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 th...

Page 12: ...ical outcome ALWAYS follow your institution s guidelines for suction limits DEATH or serious injury can result from improper suction levels WARNING NOT FOR USE as a suction source for the following ap...

Page 13: ...To Adjust the Rover Settings section G HIGH VACUUM HIGH FLOW Continuous Surgical Suction Range 50 to 480 mm Hg See the Specifications section H System Setup Button Push and hold the button until the S...

Page 14: ...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...

Page 15: ...ter is replaced SELECT MARK Icon indicates screen option is selected and applied CONSULT INSTRUCTIONS FOR USE Icon indicates the need to consult instructions for use specifically error message informa...

Page 16: ...Code Messages section Dashes indicate the value of the volume is in transition or an error has occurred The system may still be used FULL mL FULL mL Figure 10 Fluid Level Display Audible Event Indicat...

Page 17: ...power cord through the strain relief hole before connecting the cord to the rover Figure 11 b Push the power switch to the ON position 1a 1b Figure 11 Power Cord Strain Relief c Read the WARNING mess...

Page 18: ...AUTO Figure 16 To Adjust Smoke Evacuation NOTE See the To Adjust the Rover Settings section to make setting changes as required To Adjust the Rover Settings 1 Make sure the power cord is connected be...

Page 19: ...ting Before the Procedure 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 criter...

Page 20: ...Fluid Suction Figure 22 NOTE The fluid suction tubing and suction accessory are applied parts a Install new disposable manifold s into the manifold port s Make sure the manifold s are fully twisted a...

Page 21: ...imit 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 drain...

Page 22: ...dicator NOTE The condition indication and action described in this table pertain to one or both canisters SUCTION CONDITION INDICATION ACTION HIGH SUCTION LIMIT RANGE the suction limit setting selecte...

Page 23: ...a full or almost full canister a If the 4 liter canister is full push the EMPTY 4L CANISTER button on the control panel Figure 30 Figure 30 To Empty 4 Liter Canister NOTE If the 20 liter canister has...

Page 24: ...olume level is near full capacity Fluid suction will soon stop in the full canister Five medium beeps fluid level display value flashes Prepare to switch to an alternate suction source FULL The fluid...

Page 25: ...izontal orientation f Remove all the remaining fluid suction accessories as required 1e 1d Figure 35 To Remove Manifold and Tubing 2 To Remove Smoke Evacuation Components Figure 36 a Push the EVACUATE...

Page 26: ...the rover and relocate the rover as required Use the rover handle to push and relocate the rover Figure 39 Transport Configuration 6 To Relocate the Rover WARNING TIPPING HAZARD DO NOT lean on the rov...

Page 27: ...For optimal cleaning of the rover canisters use a water temperature of 37 8 to 43 3 C 100 to 110 F The docker provides power to the rover during the docking process After docking the rover DO NOT lock...

Page 28: ...contents applies detergent to the interior walls of both canisters and rinses the detergent with water 5 minutes QUICK DRAIN Cycle drains the contents of both canisters 2 minutes EXTENDED WASH Cycle d...

Page 29: ...k for cleaning induced damage or unacceptable deterioration on all external surfaces of the rover such as corrosion discoloration pitting or cracked materials Check the canister s smoke evacuator filt...

Page 30: ...lean cloth moistened with disinfectant wipe all surfaces Make sure all surfaces remain visibly wet at room temperature for at least the minimum time specified in the instructions supplied by the disin...

Page 31: ...is damaged Replace the manifold See the Accessories section and the instructions for use supplied with the manifold The SUCTION LIMIT SETTING dials are adjusted too low Turn the SUCTION LIMIT SETTING...

Page 32: ...ontact Stryker Neptune Customer Service See the Contact Information section Fluid does not drain from the 4 liter canister into the 20 liter canister after pushing the EMPTY 4L CANISTER button A fluid...

Page 33: ...efill initiates the breakdown of fluid waste collected during the rover s next use No action is required The docker does not dispense detergent during the cleaning cycle The bottle of detergent is emp...

Page 34: ...DOCK ROVER 5 0 FILTER EXPIRED REPLACE FLUID SUCTION HEPA FILTER 5 1 FILTER EXPIRED REPLACE SMOKE FILTER 6 X EMPTY TANK ERROR CALL SERVICE CODE MESSAGE ACTION 7 0 LEVEL SENSOR ERROR CALL SERVICE 7 1 L...

Page 35: ...t 2009 Amendment 2 2010 Underwriters Laboratories UL UL 60601 1 Medical Electrical Equipment Part 1 General Requirements for Safety First Edition Revisions through and including April 26 2006 Internat...

Page 36: ...nce and manufacturer s declaration electromagnetic emissions The Neptune 2 ULTRA Rover REF 0702 001 000 is intended for use in the electromagnetic environment specified below The customer or the user...

Page 37: ...h 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply...

Page 38: ...pliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with the following symbol Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m Non ionizing eletrom...

Page 39: ...output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0...

Page 40: ...power must be applied to the rover The rover will not regulate the vacuum levels but will display vacuum and volume values and provide an audible indication if the canister fluid levels exceed their...

Page 41: ...S www stryker com Stryker Instruments 4100 E Milham Kalamazoo Michigan USA 49001 1 269 323 7700 1 800 253 3210 FR CA 0702 002 712 0000016914 Rev S Effective Date Mar 11 2016 9 46 10 AM Printed Date F...

Page 42: ...e S Joseph Kaylee CA_Quality Engineer 2016 02 18 09 04 43 EST Approve S Pasos Roberto CA_Product Safety 2016 02 26 14 10 00 EST Approve S Pulliam Sylvia Document Control 2016 02 26 14 50 41 EST Comple...

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