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3

MAXI

Infant SpO

2

 Sensor

Identification of a substance that 

is contained or present within the 

product or packaging.

Identification of a substance that is 

not contained or present within the 

product or packaging.

This product cannot be adequately cleaned and/or sterilized by the user in order to facilitate 

safe reuse, and is therefore intended for single use. Attempts to clean or sterilize these 

devices may result in bio-incompatibility, infection or product failure risks to the patient.
This device is not made with natural rubber latex or DEHP.

Directions for Use

Indications/Contraindications

The Nellcor™ Infant SpO

2

 Sensor, model MAXI, is indicated for single patient use when 

continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for 

patients weighing between 3 and 20 kg.
The MAXI is contraindicated for use on patients who exhibit allergic reactions to the adhesive 

tape.

Note:

  Adhesive sensor consists of sensor, cable and wrap adhesive flaps.

Instructions for Use

1.  Remove plastic backing from the MAXI and locate transparent windows (b) on the 

adhesive side. Windows cover optical components. Note corresponding alignment marks 

(a) on the nonadhesive side and the dashed line (c) midway between the marks. 

 1 

A great toe is the preferred MAXI location. Alternatively, apply the sensor to another digit 

of similar size, for example, a thumb.

Note:

  When selecting a sensor site, priority should be given to an extremity free of an arterial 

catheter, blood pressure cuff, or intravascular infusion line.

2.  Orient the MAXI so the window next to the cable is aligned on the bottom of the great 

toe as shown. The cable should extend towards the heel. 

 2 

3.  Wrap the MAXI firmly, but not too tightly around the toe. Windows must oppose each 

other. 

 3 

4.  Wrap any excess tape loosely around toe. Use additional tape provided to secure cable 

across bottom of foot, loosely enough to maintain good circulation. 

 4 

5.  Plug the MAXI into the oximeter and verify proper operation as described in the oximeter 

operator’s manual.

Note:

  If the sensor does not track the pulse reliably, it may be incorrectly positioned—or the 

sensor site may be too thick, thin, or deeply pigmented, or otherwise deeply colored 

(for example, as a result of externally applied coloring such as nail polish, dye, or 

pigmented cream) to permit appropriate light transmission. If any of these situations 

occurs, reposition the sensor or choose an alternate Nellcor sensor for use on a 

different site.

To remove the Adhesive Sensor:

1.  Peel the tape wrap to gently remove the sensor.

2.  Disconnect the sensor from the monitor by unplugging the sensor from the extension 

cable or monitor.

Reapplication

The MAXI can be reused on the same patient as long as the adhesive tape attaches without 

slippage.

en

Содержание Nellcor MAXI

Страница 1: ...nl Gebruiksaanwijzing it Istruzioni per l uso es Instrucciones de uso sv Bruksanvisning da Betjeningsvejledning no Bruksanvisning fi K ytt ohjeet pt Instru es de uso ru zh pl Instrukcja u ycia cs N vo...

Страница 2: ...2 1 a b c 2 3 4...

Страница 3: ...tion Alternatively apply the sensor to another digit of similar size for example a thumb Note When selecting a sensor site priority should be given to an extremity free of an arterial catheter blood p...

Страница 4: ...rrect optical alignment If skin integrity changes move the sensor to another site If the sensor is misapplied with excessive pressure a pressure injury can occur 8 Deeply pigmented skin intravascular...

Страница 5: ...ecifications Operational temperature range 0 C to 50 C Storage temperature range 40 C to 70 C Operational and Storage Relative humidity range 15 to 95 non condensing Additional Copies of Instructions...

Страница 6: ...res de l alignement correspondant a sur la face non adh sive et la ligne pointill e du milieu c mi chemin entre les rep res 1 Le gros orteil est l emplacement privil gi du MAXI Sinon appliquer le cap...

Страница 7: ...se application du MAXI peut entra ner des mesures incorrectes 5 Si le capteur est envelopp de mani re trop serr e ou si une bande suppl mentaire est appliqu e les pulsations veineuses peuvent fausser...

Страница 8: ...bricant Capteur Saturation Pr cision 70 100 2 chiffres 70 100 3 chiffres avec mouvement test avec le moniteur PM1000N Pour un r sum des essais cliniques et les courbes Bland Altman de l tude clinique...

Страница 9: ...enden Ausrichtungsmarkierungen a auf der nicht klebenden Seite und die gestrichelte Linie c in der Mitte zwischen den Markierungen 1 F r das Anbringen des MAXI sollte vor allem die gro e Zehe benutzt...

Страница 10: ...sungen f hren kann 4 Wenn der MAXI nicht korrekt angelegt wird k nnen fehlerhafte Messungen entstehen 5 Wenn der Sensor zu fest gewickelt oder zus tzliches Klebeband angebracht wird kann die Venenpuls...

Страница 11: ...Nellcor OxiMax kompatiblen Ger t an Genauigkeit der Sensor S ttigung 70 bis 100 2 Ziffern 70 bis 100 3 Ziffern mit Bewegung mit einem PM1000N berwachungsger t getestet Die klinische Zusammenfassung un...

Страница 12: ...zijde en de streepjeslijn c in het midden tussen de markeringen 1 Een grote teen is de voorkeurslocatie voor de MAXI In plaats daarvan kan de sensor worden aangebracht op een andere vinger of teen van...

Страница 13: ...dt gewikkeld of er extra tape wordt aangebracht kunnen veneuze pulsaties tot onjuiste saturatiemetingen leiden 6 Hoewel de MAXI is ontworpen om de effecten van omgevingslicht te reduceren kan overmati...

Страница 14: ...neemt u contact op met de fabrikant Nauwkeurigheid saturatie van de sensor 70 tot 100 2 cijfers 70 tot 100 3 cijfers met beweging getest met de PM1000N monitor Raadpleeg de bedieningshandleiding van h...

Страница 15: ...tro dito di dimensioni simili ad esempio il pollice Nota nel selezionare un sito per il sensore opportuno dare la priorit a un estremit libera da cateteri arteriosi manicotti per la misurazione della...

Страница 16: ...in modo da ridurre gli effetti della luce ambientale la luce eccessiva pu determinare misurazioni inaccurate In tal caso coprire il sensore con materiale opaco 7 Controllare regolarmente la circolazi...

Страница 17: ...per gli studi clinici Specifiche ottiche Lunghezza d onda dei LED approssimativa Potenza di uscita Rosso 650 670 nm 3 0 mW Infrarosso 880 910 nm 4 0 mW L intervallo di lunghezza d onda pu essere part...

Страница 18: ...e aplicar el sensor en otro dedo de tama o similar como el dedo pulgar Nota Cuando seleccione un sitio para el sensor se debe dar prioridad a la extremidad que no tenga un cat ter arterial manguito de...

Страница 19: ...luz ambiental una iluminaci n excesiva podr a provocar mediciones incorrectas En esos casos cubra el sensor con un material opaco 7 Deber a comprobarse peri dicamente la circulaci n distal de la ubica...

Страница 20: ...land Altman de los estudios cl nicos Especificaciones pticas Longitud de onda LED aproximada Potencia de salida Rojo 650 a 670 nm 3 0 mW Infrarrojo 880 a 910 nm 4 0 mW Este intervalo de longitud de on...

Страница 21: ...vv gs mellan m rkena 1 Placering av MAXI p en stort r att f redra Applicera alternativt sensorn p ett annat finger av liknande storlek till exempel en tumme Obs N r du v ljer sensorst lle b r du prior...

Страница 22: ...sensorplatsen ska kontrolleras rutinm ssigt Platsen m ste inspekteras minst var 8 timme f r att kontrollera vidh ftning applikationstryck hudstatus och r tt optisk placering Om hudstatus f r ndras sk...

Страница 23: ...0 nm 3 0 mW Infrar d 880 till 910 nm 4 0 mW V gl ngdsintervall kan vara s rskilt anv ndbar f r kliniker Milj specifikationer Driftstemperaturintervall 0 C till 50 C Temperaturomr de vid f rvaring 40 C...

Страница 24: ...linje c midt mellem m rkerne 1 En storet er det foretrukne sted at anbringe MAXI Ellers kan sensoren anbringes p en finger af lignende st rrelse f eks en tommelfinger Bem rk Ved valg af p s tningssted...

Страница 25: ...kkes rutinem ssigt at der er blodcirkulation distalt for sensorstedet Stedet skal inspiceres hver 8 time for at sikre at sensoren sidder fast at p s tningstrykket er korrekt at huden er intakt og at o...

Страница 26: ...r LED b lgel ngde omtrentlig Udgangseffekt R d 650 til 670 nm 3 0 mW Infrar d 880 til 910 nm 4 0 mW Et b lgel ngdeinterval kan is r v re nyttigt for klinikere Milj m ssige specifikationer Driftstemper...

Страница 27: ...c midt mellom merkene 1 MAXI skal helst plasseres p en stort Sensoren kan ogs plasseres p en finger med tilsvarende st rrelse f eks tommelfingeren Merk Ved valg av sensorsted b r det helst velges en e...

Страница 28: ...tet og korrekt optisk sammenstilling Ved hudirritasjon b r sensoren flyttes Hvis sensoren plasseres med for mye trykk kan trykkskade oppst 8 Dypt pigmentert hud intravaskul re fargestoffer eller ytre...

Страница 29: ...Milj betingelser Temperaturomr de for drift 0 C til 50 C Temperaturomr de for oppbevaring 40 C til 70 C Relativt fuktighetsomr de for drift og oppbevaring 15 til 95 ikke kondenserende Ytterligere eks...

Страница 30: ...ehtoisesti johonkin toiseen samankokoiseen sormeen varpaaseen esimerkiksi peukaloon Huomautus Anturin kiinnityskohtaa valittaessa on k ytett v ensisijaisesti raajaa jossa ei ole valtimokatetria verenp...

Страница 31: ...armistetaan anturin kiinnitys kiinnityspaine ihon eheys ja optisten komponenttien oikea kohdistus Jos ihon kunto heikkenee siirr anturi uuteen paikkaan Jos anturin kiinnitt misess k ytet n liikaa puri...

Страница 32: ...rityisen hy dyllisi kliinikoille Ymp rist m ritykset K ytt l mp tila 0 C 50 C S ilytysl mp tila 40 C 70 C Suhteellinen kosteus k ytt ja s ilytystiloissa 15 95 ei tiivistyv K ytt ohjeiden lis kopiot N...

Страница 33: ...do p Ou ent o aplique o sensor em um outro dedo de tamanho similar por exemplo um polegar Observa o Ao selecionar o local do sensor d prioridade a uma extremidade que n o tenha cateter arterial esfig...

Страница 34: ...de luz pode provocar medi es imprecisas Nesses casos cubra o sensor com um material opaco 7 A circula o distal no local do sensor deve ser verificada regularmente O local deve ser inspecionado a cada...

Страница 35: ...l do operador de cada instrumento Especifica es pticas Comprimento de onda do LED aproximado Pot ncia de sa da Vermelho 650 a 670 nm 3 0 mW Infravermelho 880 a 910 nm 4 0 mW O intervalo do comprimento...

Страница 36: ...36 MAXI SpO2 Nellcor SpO2 MAXI 3 20 MAXI 1 MAXI b a c 1 MAXI 2 MAXI 2 3 MAXI 3 4 4 5 MAXI Nellcor ru...

Страница 37: ...37 1 2 MAXI 1 Nellcor OxiMax Nellcor Nellcor OxiMax Nellcor 2 3 MAXI MAXI 4 1 2 3 4 MAXI 5 6 MAXI 7 8 8 9 10 MAXI 11 Nellcor...

Страница 38: ...38 Nellcor OxiMax OxiMax OxiMax Nellcor OxiMax Nellcor OxiMax Nellcor OxiMax 70 100 2 70 100 3 PM1000N 650 670 3 0 880 910 4 0 0 50 C 40 70 C 15 95 Covidien Covidien Covidien Coviden...

Страница 39: ...39 MAXI SpO2 DEHP Nellcor SpO2 MAXI 3 kg 20 kg MAXI 1 MAXI b a c 1 MAXI 2 MAXI 2 3 MAXI 3 4 4 5 MAXI L Nellcor 1 2 MAXI zh...

Страница 40: ...x Nellcor OxiMax 2 3 MRI MAXI MAXI MRI MRI 4 1 2 3 4 MAXI 5 6 MAXI 7 8 8 9 10 MAXI 11 Nellcor Nellcor OxiMax OxiMax OxiMax Nellcor OxiMax Nellcor OxiMax Nellcor OxiMax 70 100 2 70 100 3 PM1000N Bland...

Страница 41: ...41 0 C 50 C 40 C 70 C 15 95 Covidien Covidien Covidien Covidien...

Страница 42: ...wag na znaczniki wyr wnania a po stronie nieprzylepnej i na przerywan lini c mi dzy znacznikami 1 Preferowanym miejscem lokalizacji czujnika MAXI jest paluch Alternatywnie mo na za o y czujnik na inny...

Страница 43: ...owini ty zbyt mocno lub u yto dodatkowej ta my pulsacje ylne mog spowodowa nieprawid owe pomiary nasycenia 6 Pomimo faktu i czujnik MAXI zosta zaprojektowany pod k tem redukcji wp ywu o wietlenia oto...

Страница 44: ...k adno od 70 do 100 2 znaki od 70 do 100 3 znaki przy ruchu testowano z monitorem PM1000N Nale y skorzysta z odpowiedniego podr cznika operatora urz dzenia aby uzyska informacje o testach klinicznych...

Страница 45: ...em k aplikaci senzoru MAXI je palec nohy Senzor m ete rovn nasadit na jin prst podobn velikosti nap klad na palec ruky Pozn mka P i v b ru m sta aplikace senzoru volte p ednostn kon etinu bez arteri l...

Страница 46: ...sv tla nadm rn osv tlen m e zp sobit nep esn m en V takov ch p padech p ekryjte senzor nepr svitn m materi lem 7 Pravideln kontrolujte cirkulaci krve dist ln od m sta aplikace senzoru M sto aplikace k...

Страница 47: ...hrn klinick ho testov n a Bland Altmanovy grafy z klinick ch studi najdete v u ivatelsk p ru ce k p slu n mu p stroji Optick parametry Vlnov d lka LED p ibli n V stupn v kon erven z en 650 a 670 nm 3...

Страница 48: ...ite na drug prst podobne velikosti na primer palec Opomba Ko izbirate mesto za namestitev senzorja morate dati prednost okon ini na kateri ni name enega arterijskega katetra man ete za merjenje krvneg...

Страница 49: ...te ustrezno lepljenje pritisk nanosa nepo kodovanost ko e in pravilno opti no naravnanost e pride do po kodbe ko e senzor premaknite na drugo mesto e je senzor napa no name en s prekomernim pritiskom...

Страница 50: ...e je lahko e posebej uporaben za klini ne zdravstvene delavce Specifikacije okolja Razpon delovnih temperatur od 0 do 50 C Razpon temperatur shranjevanja od 40 do 70 C Razpon relativne vla nosti za up...

Страница 51: ...ym snak megfelel beigaz t si jelz sekre a a nem ragaszt s oldalon s a szaggatott vonalra c a jelz sek k z tt k z pen 1 A MAXI modell rz kel t legc lszer bb a nagyl bujjra felhelyezni Emellett felhelye...

Страница 52: ...kel m k d si hib j t okozhatja illetve hib s oximetri s m r seket eredm nyezhet 4 A MAXI modell rz kel nem megfelel felhelyez se helytelen m r si eredm nyeket okozhat 5 Ha az rz kel t l szorosan van...

Страница 53: ...tve forduljon a gy rt hoz Az rz kel ltal jelzett tel tetts g pontoss ga A 70 100 tartom nyon bel l 2 sz mjegy A 70 100 tartom nyon bel l mozg s mellett 3 sz mjegy A PM1000N modell monitorral t rt nt t...

Страница 54: ...54 MAXI SpO2 2 o o DEHP SpO2 Nellcor MAXI 3 20 kg MAXI 1 MAXI b a c 1 MAXI 2 MAXI 2 3 MAXI 3 4 4 5 MAXI Nellcor el...

Страница 55: ...55 1 2 MAXI 1 Nellcor OxiMax Nellcor Nellcor OxiMax Nellcor 2 3 MAXI MAXI 4 1 2 3 4 MAXI 5 6 MAXI 7 8 8 9 10 MAXI...

Страница 56: ...Nellcor OxiMax OxiMax OxiMax Nellcor OxiMax Nellcor OxiMax Nellcor OxiMax 70 100 2 70 100 3 PM1000N Bland Altman LED 650 670 nm 3 0 mW 880 910 nm 4 0 mW 0 C 50 C 40 C 70 C 15 95 Covidien Covidien Covi...

Страница 57: ...arak sens r ayn b y kl kteki bir parma a rne in el ba parma na uygulay n Not Bir sens r b lgesi se erken arteriyel kateter tansiyon man onu ya da intravask ler inf zyon hatt olmayan bir kol tercih edi...

Страница 58: ...melidir Cilt b t nl de i irse sens r ba ka bir b lgeye ta y n Sens re yanl bi imde yo un bir bask uygulan rsa bir bas n hasar olu abilir 8 ok pigmentli cilt intravask ler boyalar veya harici renklendi...

Страница 59: ...l t rma s cakl aral 0 C ila 50 C Saklama s cakl aral 40 C ila 70 C al t rma ve Saklama Ba l nem aral 15 ila 95 yo u mas z Talimatlar n Ek Kopyalar Bu talimatlar n ek kopyalar cretsiz olarak Covidien v...

Страница 60: ...ile retilmemi tir en Single use fr Usage unique de Zur einmaligen Verwendung nl Eenmalig gebruik it Monouso es Un solo uso sv Endast f r eng ngsbruk da Til engangsbrug no Til engangsbruk fi Kertak yt...

Страница 61: ...assa el a haszn lati utas t st el tr Kullanma talimat na bak n en Follow instructions for use fr Suivre le mode d emploi de Gebrauchsanweisung befolgen nl Volg de gebruiksaanwijzing it Seguire le istr...

Страница 62: ...auftreffende Wassertropfen bei einer Neigung des Sensors um bis zu 15 nl Beschermd tegen toegang tot gevaarlijke delen met een vinger en beschermd tegen verticaal vallende waterdruppels wanneer de sen...

Страница 63: ...el s gi jel l s 0123 tan s t si szervezet el CE Conformit Europ ene 0123 tr CE Conformit Europ ene onay i areti 0123 onayl kurum en REF Catalogue number fr REF Num ro de r f rence de REF Artikelnummer...

Страница 64: ...of a Covidien company 2012 Covidien Covidien llc 15 Hampshire Street Mansfield MA 02048 USA Covidien Ireland Limited IDA Business Technology Park Tullamore www covidien com 0123 Not made with natural...

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