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Stryker 0702-034-000, Instructions For Use Manual

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Pearson, Dawn

Editor

2016-04-29 12:35:41 EDT

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Keeler, Stephanie

CA_Owner

2016-05-17 10:03:13 EDT

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Wiersema, Kim

CA_Regulatory

Affairs

2016-05-17 10:07:55 EDT

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Nollar, Andrew

CA_Marketing

Manager

2016-05-17 10:29:32 EDT

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Ekola, David

CA_Quality Engineer

2016-05-17 13:24:22 EDT

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Sahu, Sameer

CA_Product Design

Engineer

2016-05-19 10:11:50 EDT

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[email protected]

CA_Product Safety

2016-05-25 10:18:24 EDT

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Snell, Tami

Document Control

2016-05-25 11:08:06 EDT

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Pearson, Dawn

Editor

2016-05-26 17:28:08 EDT

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Keeler, Stephanie

CA_Owner

2017-01-27 16:12:36 EST

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

Related Information

CR Number

CR0220549

CR Class

DMR-Commercially Released

Originating Entity

INST: Kalamazoo

Origin

Product Improvement

Initial CR Approval Date

11/06/2014 16:18:45

CN Number

CN146732

CA Number

CA108287

NPD Disposition Plan

0000012816, Rev. H Effective Date: Mar 7, 2017 12:56:42 PM

Print Date: Mar 07, 2017 04:15:37 PM

Summary of Contents for 0702-034-000

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

Page 2: ...ement System Fluid Suction HEPA Filter 0702 034 000 ENGLISH EN ESPA OL ES DEUTSCH DE FRAN AIS FR ITALIANO IT NEDERLANDS NL SVENSKA SV DANSK DA SUOMI FI PORTUGU S PT NORSK NO POLSKI PL EL JA ZH KO 0000...

Page 3: ...acuated from the fluid collection canister s of the rover before the air is vented Symbol Definitions The symbols located on the equipment and or labeling are defined in this section or in the Symbol...

Page 4: ...may cause media damage and result in patient and or healthcare staff injury Figure 1 To Prevent Filter Media Damage Instructions NOTE See the instructions for use supplied with your rover for control...

Page 5: ...HIGH SUCTION DEVICE WARNING 8 Press the SUCTION ON OFF button and turn the SUCTION LIMIT SETTING dial of either canister to the maximum suction level Make sure the maximum suction level value on the...

Page 6: ...SYSTEM SETUP VOLUME DISPLAY UNITS VOLUME DISPLAY BRIGHT FLUID AUDIBLE INDICATORS VACUUM DISPLAY BRIGHT VACUUM DISPLAY CONTRAST SMOKE FILTER LIFE SUCTION FILTER LIFE ERROR HISTORY Figure 5 To Select Su...

Page 7: ...ency Particulate Air HEPA del aire evacuado del de los dep sito s de recogida de l quido del colector m vil antes de expulsarlo al exterior Definiciones de los s mbolos En este apartado o en el Gr fic...

Page 8: ...se expulse al exterior Si se hace caso omiso de esta instrucci n se podr a da ar el material del filtro y causar lesiones al paciente o al personal sanitario Figura 1 Evite que el material del filtro...

Page 9: ...y acepte la ADVERTENCIA DE ASPIRACI N ALTA DEL DISPOSITIVO 8 Pulse el bot n de ENCENDIDO APAGADO DE LA ASPIRACI N y gire el DIAL de ajuste del vac o de ambos dep sitos hasta el nivel m ximo de aspira...

Page 10: ...l bot n junto a OK para realizar la selecci n figura 5 OK ESC CONFIG SIST VOLUME DISPLAY UNITS VOLUME DISPLAY BRIGHT FLUID AUDIBLE INDICATORS VACUUM DISPLAY BRIGHT VACUUM DISPLAY CONTRAST SMOKE FILTER...

Page 11: ...articulate Air hocheffizienter Luftpartikelfilter der aus den Fl ssigkeits Sammelbeh ltern des mobilen Absaugger ts abgesaugten Luft bevor sie abgelassen wird Symboldefinitionen Erl uterungen der am G...

Page 12: ...en Absaugger ts abgesaugte Luft bevor sie abgelassen wird Nichtbeachtung kann Sch den am Filtermaterial bewirken und zu Verletzungen von Patient und oder medizinischem Personal f hren Abbildung 1 Sch...

Page 13: ...MIT HOHER ABSAUGUNG best tigen 8 Die Taste ABSAUGUNG EIN AUS dr cken und das Einstellrad einer der beiden Beh lter zur Anpassung der SAUGLEISTUNGSGRENZEN auf die maximale Absaugung drehen Sicherstell...

Page 14: ...ldung 5 OK ESC SYSTEMSETUP VOLUME DISPLAY UNITS VOLUME DISPLAY BRIGHT FLUID AUDIBLE INDICATORS VACUUM DISPLAY BRIGHT VACUUM DISPLAY CONTRAST SMOKE FILTER LIFE ABSAUGFILT HALTB Abbildung 5 Absaugfilter...

Page 15: ...de Description Le filtre air particulaire tr s haute efficacit High Efficiency Particulate Air HEPA assure la filtration de l air extrait de la ou des cuves de recueil des liquides du Nomade avant l c...

Page 16: ...tion filtrent l air extrait de la ou des cuves de recueil des liquides du Nomade avant l chappement de l air Le non respect de cette consigne peut endommager les mat riaux de filtration et entra ner d...

Page 17: ...t accepter l AVERTISSEMENT DISPOSITIF FORTE ASPIRATION 8 Appuyer sur le bouton MARCHE ARR T ASPIRATION et tourner le bouton R GLAGE DES LIMITES DE L ASPIRATION de chaque cuve sur le niveau d aspiratio...

Page 18: ...r effectuer la s lection Figure 5 OK ESC CONF SYST VOLUME DISPLAY UNITS VOLUME DISPLAY BRIGHT FLUID AUDIBLE INDICATORS VACUUM DISPLAY BRIGHT VACUUM DISPLAY CONTRAST SMOKE FILTER LIFE DUR E FILT ASP ER...

Page 19: ...Il filtro progettato per il filtraggio ad alta capacit delle particelle in sospensione High Efficiency Particulate Air HEPA nell aria evacuata dal i contenitore i di raccolta dei fluidi dell Unit mobi...

Page 20: ...traggio filtra l aria evacuata dal i contenitore i di raccolta dei fluidi dell Unit mobile prima che l aria stessa venga sfiatata Il mancato rispetto di questa avvertenza pu causare danni al materiale...

Page 21: ...I DISPOSITIVO AD ASPIRAZIONE ELEVATA 8 Premere il pulsante ASPIRAZIONE ON OFF e ruotare il selettore di IMPOSTAZIONE DEI LIMITI DELL ASPIRAZIONE di uno dei due contenitori sul livello massimo di aspir...

Page 22: ...l pulsante accanto a OK per eseguire la selezione Figura 5 OK ESC IMPOSTAZ SISTEMA VOLUME DISPLAY UNITS VOLUME DISPLAY BRIGHT FLUID AUDIBLE INDICATORS VACUUM DISPLAY BRIGHT VACUUM DISPLAY CONTRAST SMO...

Page 23: ...ate Air HEPA uit de lucht die v r de ontluchting uit de vloeistofopvangbeker s van de mobiele eenheid wordt verwijderd Verklaring van de symbolen De symbolen op de apparatuur en de etikettering en in...

Page 24: ...ving hiervan kan tot beschadiging van de media en tot letsel van de pati nt en of het medisch personeel leiden Afbeelding 1 Beschadiging van filtermedia voorkomen Instructies OPMERKING Zie de met de m...

Page 25: ...voor hulpmiddel met sterke afzuiging 8 Druk op de AAN UIT knop voor SUCTION afzuiging en zet de draaiknop voor HET INSTELLEN VAN DE BEGRENZING VAN DE AFZUIGING van een van beide opvangbekers op maxima...

Page 26: ...ding 5 OK ESC SYSTEM SETUP VOLUME DISPLAY UNITS VOLUME DISPLAY BRIGHT FLUID AUDIBLE INDICATORS VACUUM DISPLAY BRIGHT VACUUM DISPLAY CONTRAST SMOKE FILTER LIFE SUCTION FILTER LIFE ERROR HISTORY Afbeeld...

Page 27: ...ltret tillhandah ller h geffektiv partikelfiltrering av luft High Efficiency Particulate Air HEPA som evakueras fr n den mobila sugenhetens kanister kanistrar f r uppsamling av v tska innan luften t m...

Page 28: ...Materialet filtrerar den luft som evakueras fr n den mobila sugenhetens kanister kanistrar f r uppsamling av v tska innan luften t ms ut Underl tenhet att f lja anvisningarna kan orsaka skada p materi...

Page 29: ...VICE WARNING Varning f r enhet med h g sugkraft 8 Tryck p knappen f r att sl p st nga av SUCTION Sugning och vrid skivan f r SUGGR NSINST LLNING f r endera kanistern till den h gsta sugniv n MAX S ker...

Page 30: ...figur 5 OK ESC SYSTEM SETUP VOLUME DISPLAY UNITS VOLUME DISPLAY BRIGHT FLUID AUDIBLE INDICATORS VACUUM DISPLAY BRIGHT VACUUM DISPLAY CONTRAST SMOKE FILTER LIFE SUCTION FILTER LIFE ERROR HISTORY Figur...

Page 31: ...HEPA der udsuges fra v skesamlingsbeholderne i det mobile sugeapparat f r luften ventileres Symboldefinitioner Symbolerne p udstyret og eller etiketterne defineres i dette afsnit eller i Diagram over...

Page 32: ...ende overholdelse kan resultere i beskadigelse af mediet og resultere i skade p patient og eller hospitalspersonale Figur 1 Forebyg beskadigelse af filtermedie Anvisninger BEM RK Se brugsanvisningen d...

Page 33: ...E WARNING advarsel for apparat med kraftig sugning 8 Tryk p t nd sluk knappen for SUCTION sugning og drej drejeknappen for INDSTILLING AF SUGEGR NSE p en af beholderne over p det maksimale sugeniveau...

Page 34: ...OK ESC SYSTEM SETUP VOLUME DISPLAY UNITS VOLUME DISPLAY BRIGHT FLUID AUDIBLE INDICATORS VACUUM DISPLAY BRIGHT VACUUM DISPLAY CONTRAST SMOKE FILTER LIFE SUCTION FILTER LIFE ERROR HISTORY Figur 5 V lg...

Page 35: ...netyn ilman puhdistamisen suuritehoisella hiukkasilman High Efficiency Particulate Air HEPA suodatuksella ennen ilman poistamista Merkkien selitykset Laitteistossa tai tuoteselosteissa olevat symbolit...

Page 36: ...y nnist voi olla seurauksena materiaalin vaurioituminen ja potilaaseen ja tai terveydenhoitohenkil kuntaan kohdistuva vamma Kuva 1 Suodattimen vaurioiden est minen Ohjeet HUOMAUTUS Katso ohjauspaneeli...

Page 37: ...p lle Kuittaa HIGH SUCTION DEVICE WARNING voimakasimuisen laitteen varoitus varoitus 8 Paina SUCTION imu k ynnistyspainiketta ja k nn jommankumman s ili n IMUASETUKSEN valitsin s ili n maksimaaliseen...

Page 38: ...a kuva 5 OK ESC SYSTEM SETUP VOLUME DISPLAY UNITS VOLUME DISPLAY BRIGHT FLUID AUDIBLE INDICATORS VACUUM DISPLAY BRIGHT VACUUM DISPLAY CONTRAST SMOKE FILTER LIFE SUCTION FILTER LIFE ERROR HISTORY Kuva...

Page 39: ...o O filtro disponibiliza uma filtra o de alta efici ncia das part culas do ar High Efficiency Particulate Air HEPA evacuadas a partir do s recipiente s de recolha de l quido do colector m vel antes d...

Page 40: ...o filtro Figura 1 Os meios de filtra o filtram o ar evacuado a partir do s recipiente s de recolha de l quidos do colector m vel antes de o ar ser expelido O n o cumprimento desta advert ncia poder pr...

Page 41: ...NCIA DISPOSITIVO DE ELEVADA POT NCIA DE ASPIRA O 8 Prima o bot o LIGAR DESLIGAR ASPIRA O e rode o bot o DEFINI O DE LIMITE DE ASPIRA O do recipiente para o n vel de aspira o m ximo Certifique se de qu...

Page 42: ...gura 5 OK ESC CONFIGUR SISTEMA VOLUME DISPLAY UNITS VOLUME DISPLAY BRIGHT FLUID AUDIBLE INDICATORS VACUUM DISPLAY BRIGHT VACUUM DISPLAY CONTRAST SMOKE FILTER LIFE DUR FILT ASPIR ERROR HISTORY Figura 5...

Page 43: ...A filtrering i luften som pumpes ut fra v skebeholderen e p den mobile enheten f r luften ventileres Symbolforklaring Symbolene som finnes p utstyret og eller i dokumentasjonen er definert i dette avs...

Page 44: ...n f re til skader p materialene og resultere i skade p pasient og eller helsepersonell Figur 1 Unng skader p filtermaterialene Instruksjoner MERKNAD Se bruksanvisningen som f lger med den mobile enhet...

Page 45: ...SUCTION DEVICE WARNING varsel om enhet med h yt sug 8 Trykk p SUCTION sug P AV bryteren og drei hjulet for INNSTILLING AV SUG til maksimalt sugeniv MAX for hver av beholderne Pass p at verdien for mak...

Page 46: ...VOLUME DISPLAY UNITS VOLUME DISPLAY BRIGHT FLUID AUDIBLE INDICATORS VACUUM DISPLAY BRIGHT VACUUM DISPLAY CONTRAST SMOKE FILTER LIFE SUCTION FILTER LIFE ERROR HISTORY Figur 5 Velge alternativ for sugef...

Page 47: ...pis Wysokosprawny filtr powietrza High Efficiency Particulate Air HEPA zapewnia filtracj powietrza odsysanego ze zbiornika w do gromadzenia p yn w w zka przed wydaleniem go do atmosfery Definicje symb...

Page 48: ...cy filtruje powietrze usuwane ze zbiornika w do gromadzenia p yn w w zka przed wydaleniem powietrza do atmosfery Nieprzestrzeganie tych zalece mo e spowodowa uszkodzenie wk adu filtruj cego i doprowad...

Page 49: ...Nacisn PRZYCISK W CZANIA WY CZANIA SSANIA i obr ci tarcz do USTAWIANIA LIMITU SSANIA na dowolnym zbiorniku do maksymalnego poziomu podci nienia Upewni si e zosta a uzyskana maksymalna warto poziomu po...

Page 50: ...rysunek 5 OK ESC KONFIG SYS VOLUME DISPLAY UNITS VOLUME DISPLAY BRIGHT FLUID AUDIBLE INDICATORS VACUUM DISPLAY BRIGHT VACUUM DISPLAY CONTRAST SMOKE FILTER LIFE TRW FILTRA SSANIA Rysunek 5 Wybieranie...

Page 51: ...ement System Neptune 2 Stryker Neptune Stryker 1 800 550 7836 HEPA Fluid Suction HEPA Filter Stryker REF 0702 034 000 Neptune 2 High Efficiency Particulate Air HEPA o 2 1 3 4 6 5 6 M 0000012816 Rev H...

Page 52: ...702 034 700 Rev H EL www stryker com 51 Stryker Neptune Stryker Personal Protective Equipment PPE 1 1 500 1 2 2 0000012816 Rev H Effective Date Mar 7 2017 12 56 42 PM Print Date Mar 07 2017 04 15 37 P...

Page 53: ...ww stryker com 2 3 4 5 2 6 7 HIGH SUCTION DEVICE WARNING 8 SUCTION MAX 3 9 Stryker Neptune HIGH 480 mm Hg SETTING LOW 60 mm Hg SETTING 3 0000012816 Rev H Effective Date Mar 7 2017 12 56 42 PM Print Da...

Page 54: ...D AUDIBLE INDICATORS VACUUM DISPLAY BRIGHT VACUUM DISPLAY CONTRAST SMOKE FILTER LIFE SUCTION FILTER LIFE ERROR HISTORY 5 5 SUCTION FILTER LIFE RESETS TIMER 500 hours 500 6 ESC SUCTION FILTER LIFE x 50...

Page 55: ...agement System Neptune 2 Stryker Stryker Neptune 1 800 550 7836 Stryker HEPA Fluid Suction HEPA Filter REF 0702 034 000 Neptune 2 High Efficiency Particulate Air HEPA 2 1 3 4 6 5 6 0000012816 Rev H Ef...

Page 56: ...02 034 700 Rev H JA www stryker com 55 Stryker Stryker Neptune Personal Protective Equipment PPE 1 1 6 500 1 2 2 0000012816 Rev H Effective Date Mar 7 2017 12 56 42 PM Print Date Mar 07 2017 04 15 37...

Page 57: ...ww stryker com 2 3 4 5 2 6 7 HIGH SUCTION DEVICE WARNING 8 SUCTION MAX 3 9 Stryker Neptune HIGH 480 mm Hg SETTING LOW 60 mm Hg SETTING 3 0000012816 Rev H Effective Date Mar 7 2017 12 56 42 PM Print Da...

Page 58: ...D AUDIBLE INDICATORS VACUUM DISPLAY BRIGHT VACUUM DISPLAY CONTRAST SMOKE FILTER LIFE SUCTION FILTER LIFE ERROR HISTORY 5 5 SUCTION FILTER LIFE RESETS TIMER 500 hours 500 6 ESC SUCTION FILTER LIFE x 50...

Page 59: ...nagement System Neptune 2 Stryker Stryker Neptune 1 800 550 7836 Stryker HEPA Fluid Suction HEPA Filter REF 0702 034 000 Neptune 2 High Efficiency Particulate Air HEPA 2 1 3 4 6 5 0000012816 Rev H Eff...

Page 60: ...02 034 700 Rev H ZH www stryker com 59 Stryker Stryker Neptune Personal Protective Equipment PPE 1 1 500 1 2 2 2 0000012816 Rev H Effective Date Mar 7 2017 12 56 42 PM Print Date Mar 07 2017 04 15 37...

Page 61: ...www stryker com 3 4 5 2 6 7 HIGH SUCTION DEVICE WARNING 8 SUCTION MAX 3 9 Stryker Neptune HIGH 480 mm Hg SETTING LOW 60 mm Hg SETTING 3 0000012816 Rev H Effective Date Mar 7 2017 12 56 42 PM Print Dat...

Page 62: ...D AUDIBLE INDICATORS VACUUM DISPLAY BRIGHT VACUUM DISPLAY CONTRAST SMOKE FILTER LIFE SUCTION FILTER LIFE ERROR HISTORY 5 5 SUCTION FILTER LIFE RESETS TIMER 500 hours 500 6 ESC SUCTION FILTER LIFE x 50...

Page 63: ...agement System Neptune 2 Stryker Stryker Neptune 1 800 550 7836 Stryker HEPA Fluid Suction HEPA Filter REF 0702 034 000 Neptune 2 High Efficiency Particulate Air HEPA 2 1 3 4 6 5 6 0000012816 Rev H Ef...

Page 64: ...034 700 Rev H KO www stryker com 63 Stryker Stryker Neptune Personal Protective Equipment PPE 1 1 6 500 1 OFF 2 2 0000012816 Rev H Effective Date Mar 7 2017 12 56 42 PM Print Date Mar 07 2017 04 15 3...

Page 65: ...ryker com 2 3 4 5 2 6 7 ON HIGH SUCTION DEVICE WARNING 8 SUCTION ON OFF MAX 3 9 Stryker Neptune HIGH 480 mm Hg SETTING LOW 60 mm Hg SETTING 3 0000012816 Rev H Effective Date Mar 7 2017 12 56 42 PM Pri...

Page 66: ...ID AUDIBLE INDICATORS VACUUM DISPLAY BRIGHT VACUUM DISPLAY CONTRAST SMOKE FILTER LIFE SUCTION FILTER LIFE ERROR HISTORY 5 5 SUCTION FILTER LIFE RESETS TIMER 500 hours 500 6 ESC SUCTION FILTER LIFE x 5...

Page 67: ...0000012816 Rev H Effective Date Mar 7 2017 12 56 42 PM Print Date Mar 07 2017 04 15 37 PM...

Page 68: ...0000012816 Rev H Effective Date Mar 7 2017 12 56 42 PM Print Date Mar 07 2017 04 15 37 PM...

Page 69: ...Rev H www stryker com Manufactured for Stryker Instruments 4100 E Milham Kalamazoo Michigan USA 49001 1 269 323 7700 1 800 253 3210 0000012816 Rev H Effective Date Mar 7 2017 12 56 42 PM Print Date Ma...

Page 70: ...wner 2015 02 19 13 24 29 EST Return to Editor H Drilich Emily Editor 2015 02 23 14 53 17 EST Continue H Yavari Fazel CA_Owner 2015 02 23 15 34 00 EST Continue H Yavari Fazel CA_Product Design Engineer...

Page 71: ...pprove H donna brown stryker com CA_Product Safety 2016 05 25 10 18 24 EDT Approve H Snell Tami Document Control 2016 05 25 11 08 06 EDT H Pearson Dawn Editor 2016 05 26 17 28 08 EDT Continue H Keeler...

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