manualshive.com logo in svg

Stryker 0702-001-000, Instructions For Use Manual, Page: 42 / 42

Share
Download
Stryker 0702-001-000 Instructions For Use Manual Download Page 42

Signature History Report

Version

Signature

Role

Event Date

Vote

S

Thompson Kristen

CA_Owner

2016-02-10 15:07:31 EST

Continue

S

Petyko, Holly (Contractor)

Editor

2016-02-12 09:58:10 EST

Continue

S

Thompson Kristen

CA_Owner

2016-02-12 10:23:28 EST

Continue

S

Nollar, Andrew

CA_Marketing

Manager

2016-02-12 10:25:01 EST

Approve

S

Thompson Kristen

CA_Clinical Sciences

2016-02-12 10:30:05 EST

Approve

S

Wiersema, Kim

CA_Regulatory

Affairs

2016-02-12 11:46:24 EST

Approve

S

Boyer, Rick

CA_Product Design

Engineer

2016-02-12 15:10:43 EST

Approve

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

Complete

S

Petyko, Holly (Contractor)

Editor

2016-03-04 09:44:35 EST

Continue

S

Thompson Kristen

CA_Owner

2016-03-04 09:46:04 EST

Approve

NOTE: IF THIS REPORT IS BLANK, PLEASE SEE WINDCHILL ECN FOR SIGNATURES.

Related Information

CR Number

CR0287180

CR Class

DMR-Commercially Released

Originating Entity

INST: Kalamazoo

Origin

Nonconformance(NC)

Initial CR Approval Date

02/05/2016 09:55:35

CN Number

CN140265

CA Number

CA163545

NPD Disposition Plan

N/A

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...

Reviews:

No comments