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Masimo Radius PPG, Руководство пользователя

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Masimo Radius PPG Скачать руководство пользователя страница 7

7

10352C-eIFU-1219

CAUTION: 

FEDERAL LAW (U.S.A.) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.

For professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.

The following symbols may appear on the product or product labeling:

SYMBOL

DEFINITION

SYMBOL

DEFINITION

SYMBOL

DEFINITION

Follow instructions 

for use 

Separate collection for electrical 

and electronic equipment (WEEE)

Caution:

 

Federal law (USA) restricts 

this device to sale by or on the 

order of a physician

Consult instructions 

for use

Lot code

Mark of conformity to European  

Medical Device Directive 93/42/EEC

Manufacturer

Catalogue number 

(model number)

Authorized representative in the 

European community

Date of manufacture

 

YYYY-MM-DD

Masimo reference number

Body weight

Use-by  

YYYY-MM-DD

X

Light Emitting Diode (LED) 

LED emits light when current 

flows through

Storage temperature range

Fragile, handle 

with care

Greater than

Keep dry

NON

STERILE

LATEX

-40 C

+70 C

+1060 hPa - +500 hPa

795 mmHg - 375 mmHg

5%-95% RH

5%

95%

%

Non-Sterile

Less than

Do not use if package is damaged

LATEX

PCX-2108A

02/13

Not made with 

natural rubber latex

Storage humidity limitation

Atmospheric pressure limitation

Caution

Bluetooth

Protected against solid foreign 

objects of 12.5 mm diameter and 

greater and protection against 

vertically falling water drops when 

enclosure is tilted at 15 degrees

Do not re-use/Single 

patient use only

Federal Communications  

Commission (FCC) Licensing

Identifies unit has been  

registered as a radio device

Instructions/Directions for Use/Manuals are available in electronic format @ http://www.Masimo.com/TechDocs

Note: eIFU is not available in all countries.

Patents: http://www.masimo.com/patents.htm
Radius PPG is a trademark of Masimo Corporation. 
Masimo, SET, X-Cal, and,   are federally registered trademarks of Masimo Corporation.

Содержание Radius PPG

Страница 1: ...h 20 23 sv Swedish 24 27 nl Dutch 28 31 da Danish 32 35 pt Portuguese 36 39 zh Chinese 40 42 ja Japanese 43 46 fi Finnish 47 50 no Norwegian 51 54 cs Czech 55 58 hu Hungarian 59 62 pl Polish 63 66 ro...

Страница 2: ...2 10352C eIFU 1219 Fig 7a Fig 7b Fig 7c Fig 6a Fig 6b Fig 6c Fig 3b Fig 1 Fig 2 Fig 4a Fig 3a Fig 4b Fig 4c Fig 5a Fig 5b Fig 5c...

Страница 3: ...3 10352C eIFU 1219 Fig 8a Fig 8b Fig 12 Fig 10 Fig 11 Fig 9...

Страница 4: ...tight due to edema will cause inaccurate readings and can cause pressure necrosis Misapplied sensors or sensors that become partially dislodged may cause incorrect measurements Misapplications due to...

Страница 5: ...wn Refer to Fig 5a 2 Wrap the adhesive wrap around the toe so the emitter is positioned on the nail bed of the great toe Complete coverage of the detector window is needed to ensure accurate data Refe...

Страница 6: ...dity 5 95 non condensing Operating Humidity 5 95 non condensing BATTERY LIFE Battery Life 96 hours in typical continuous usage COMPATIBILITY This sensor is intended for use only with devices containin...

Страница 7: ...y YYYY MM DD X Light Emitting Diode LED LED emits light when current flows through Storage temperature range Fragile handle with care Greater than Keep dry NON STERILE LATEX 40 C 70 C 1060 hPa 500 hPa...

Страница 8: ...eurs de lecture L utilisation d une bande adh sive suppl mentaire peut endommager la peau et ou provoquer une n crose par compression ou peut d t riorer le capteur Les capteurs trop serr s d s l appli...

Страница 9: ...teur sur la partie charnue du gros orteil Il est galement possible d utiliser l orteil situ c t du gros orteil ou le pouce non illustr Se reporter la fig 5a 2 Enrouler le capteur adh sif autour de l o...

Страница 10: ...ir Bland et Altman Agreement between methods of measurement with multiple observations per individual Journal of Biopharmaceutical Statistics 2007 vol 17 pp 571 582 CARACT RISTIQUES ENVIRONNEMENTALES...

Страница 11: ...d emploi Code de lot Marquage de conformit la directive europ enne relative aux dispositifs m dicaux 93 42 CEE Fabricant R f rence du catalogue r f rence du mod le Repr sentant agr dans l Union europ...

Страница 12: ...chert werden da sonst die Durchblutung eingeschr nkt und falsche Werte ermittelt werden k nnen Das Anbringen eines zus tzlichen Klebebands kann zu Sch den an der Haut oder dem Sensor und oder zu einer...

Страница 13: ...rlegen Sie das Sensorkabel so dass es ber den Fu r cken verl uft Legen Sie den Detektor an der fleischigen Stelle des gro en Zehs an Alternativ kann auch der Zeh neben dem gro en Zeh oder der Daumen v...

Страница 14: ...ur 0 C bis 50 C bei Raumfeuchtigkeit Betriebstemperatur 0 C bis 40 C bei Raumfeuchtigkeit Feuchtigkeit bei Lagerung Transport 5 bis 95 nicht kondensierend Luftfeuchtigkeit bei Betrieb 5 bis 95 nicht k...

Страница 15: ...m Arzt oder auf Anweisung eines Arztes verkauft werden Gebrauchsanweisung beachten Chargencode Konformit tskennzeichen bez glich Richtlinie 93 42 EWG ber Medizinprodukte Hersteller Katalognummer Model...

Страница 16: ...izzo di nastro supplementare pu causare danni alla cute e o necrosi da pressione oppure danneggiare il sensore I sensori applicati troppo stretti o che diventano stretti a seguito di edema danno adito...

Страница 17: ...olpastrello dell alluce In alternativa possibile utilizzare il dito del piede situato accanto all alluce o il pollice non mostrato Vedere la Fig 5a 2 Avvolgere la fascetta adesiva attorno all alluce i...

Страница 18: ...nte Umidit di conservazione trasporto dal 5 al 95 senza condensa Umidit di funzionamento dal 5 al 95 senza condensa DURATA DELLA BATTERIA Durata della batteria 96 ore in uso tipico continuo COMPATIBIL...

Страница 19: ...Masimo Peso corporeo Data di scadenza AAAA MM GG X Diodo a emissione luminosa LED Il LED emette luce quando la corrente lo attraversa Intervallo temperatura di conservazione Fragile maneggiare con cu...

Страница 20: ...mal colocados o parcialmente desplazados pueden generar mediciones incorrectas La colocaci n incorrecta del sensor debido al uso del tipo incorrecto de sensor puede causar lecturas imprecisas o impedi...

Страница 21: ...ado en el lecho ungueal del dedo gordo del pie Es necesario que la ventana del detector quede completamente cubierta para garantizar la obtenci n de datos precisos Consulte la Fig 5b 3 Aseg rese de qu...

Страница 22: ...s per individual Journal of Biopharmaceutical Statistics 2007 vol 17 pp 571 582 CONDICIONES AMBIENTALES Temperatura de almacenamiento transporte 0 50 C a humedad ambiente Temperatura de funcionamiento...

Страница 23: ...e uso C digo de lote Marca de conformidad con la Directiva europea sobre productos sanitarios 93 42 CEE Fabricante N mero de cat logo n mero de modelo Representante autorizado en la Comunidad Europea...

Страница 24: ...blir f r h rt applicerade p grund av dem kan ge felaktiga resultat och ge upphov till trycknekros Sensorer som satts p fel och sensorer som delvis sl ppt kan ge felaktiga m tv rden Sensorer som s tts...

Страница 25: ...lvh ftande omslaget runt t n s att s ndaren sitter p toppen av nagelb dden p stort n Detektorf nstret m ste t ckas fullst ndigt f r att s kerst lla korrekta data Se fig 5b 3 Kontrollera att s ndarf ns...

Страница 26: ...tfuktighet vid f rvaring transport 5 till 95 icke kondenserande Driftsluftfuktighet 5 till 95 icke kondenserande BATTERIETS LIVSL NGD Batteriets livsl ngd 96 timmar vid normal kontinuerlig anv ndning...

Страница 27: ...v nds senast MM DD X Lysdiod LED som lyser n r str m fl dar genom den F rvaringstemperaturomr de mt lig br cklig hantera varsamt St rre n F rvaras torrt NON STERILE LATEX 40 C 70 C 1060 hPa 500 hPa 79...

Страница 28: ...veroorzaakt Onjuist aangebrachte sensoren of gedeeltelijk loslatende sensoren kunnen onjuiste metingen veroorzaken Het gebruik van een verkeerd sensormodel kan onnauwkeurige afleeswaarden of het uitb...

Страница 29: ...worden gebruikt niet afgebeeld Zie afbeelding 5a 2 Plak de kleefstrook zodanig rond de grote teen dat de straler zich op het nagelbed van de teen bevindt Er worden alleen nauwkeurige gegevens verkrege...

Страница 30: ...multiple observations per individual Journal of Biopharmaceutical Statistics 2007 vol 17 pp 571 582 OMGEVING Temperatuur tijdens transport opslag 0 50 C bij omgevingsvochtigheid Bedrijfstemperatuur 0...

Страница 31: ...ksaanwijzing Partijcode Keurmerk van conformiteit met Europese richtlijn 93 42 EEG betreffende medische hulpmiddelen Fabrikant Catalogusnummer modelnummer Erkend vertegenwoordiger in de Europese Gemee...

Страница 32: ...il for rsage un jagtige m linger og kan medf re tryknekrose Sensorer der er p sat forkert eller sensorer der flytter sig fra m lestedet kan for rsage forkerte m linger Forkert p s tning pga forkerte s...

Страница 33: ...vist Se fig 5a 2 Vikl det selvkl bende b nd om t en s lyssensoren er placeret p storet ens negleleje M levinduet skal d kkes helt for at sikre at m ledataene bliver n jagtige Se fig 5b 3 S rg for at...

Страница 34: ...brug sammen med enheder der omfatter Masimo SET oximetri eller pulsoximetrimonitorer med licens til at bruge Masimo sensorer Radius PPG sensorer er kompatible med f lgende Masimo teknologiprintkort og...

Страница 35: ...r lys ved gennemstr mning Opbevaringstemperaturinterval Skr belig behandles med forsigtighed St rre end Opbevares t rt NON STERILE LATEX 40 C 70 C 1060 hPa 500 hPa 795 mmHg 375 mmHg 5 95 RH 5 95 Ikke...

Страница 36: ...pode restringir o fluxo sangu neo e resultar em leituras imprecisas A utiliza o de fita adesiva adicional pode danificar a pele e ou causar necrose por press o ou danificar o sensor Os sensores aplica...

Страница 37: ...nsor de forma a percorrer a parte superior do p Posicione o detetor na parte carnuda do dedo grande do p Em alternativa poss vel utilizar o dedo junto ao dedo grande do p ou o polegar n o ilustrado Co...

Страница 38: ...namento 5 a 95 sem condensa o AUTONOMIA DAS PILHAS Autonomia das pilhas 96 horas em utiliza o cont nua t pica COMPATIBILIDADE Este sensor destina se a ser utilizado exclusivamente com dispositivos que...

Страница 39: ...X D odo emissor de luz LED O LED emite luz quando atravessado por corrente Intervalo de temperatura em armazenamento Fr gil manusear com cuidado Maior que Manter seco NON STERILE LATEX 40 C 70 C 1060...

Страница 40: ...asimo Radius PPG SpO2 PR Masimo Masimo Radius PPG Radius PPG Radius PPG Radius PPG Radius PPG Radius PPG Radius PPG Radius PPG Masimo MX 7 14 8 x 1 SpO2 ECG MRI MRI COHb SpO2 MetHb SpO2 SpO2 SpO2 COHb...

Страница 41: ...40 kg SpO2 70 100 1 2 2 2 2 3 5 2 SpO2 2 3 3 3 3 3 3 SpO2 3 2 2 2 2 3 5 2 1 25 240 bpm 3 bpm 3 bpm 3 bpm 3 bpm 3 bpm 3 bpm 2 5 bpm 5 bpm 5 bpm 5 bpm 5 bpm 5 bpm 4 3 bpm 3 bpm 3 bpm 3 bpm 3 bpm 3 bpm...

Страница 42: ...MASIMO MASIMO MASIMO MASIMO MASIMO MASIMO MASIMO WEEE 93 42 EEC YYYY MM DD Masimo YYYY MM DD X LED LED NON STERILE LATEX 40 C 70 C 1060 hPa 500 hPa 795 mmHg 375 mmHg 5 95 RH 5 95 LATEX PCX 2108A 02 13...

Страница 43: ...g 5 95 RH 5 95 Radius PPG Masimo Radius PPG SpO2 PR Masimo Radius PPG SpO2 PR Masimo Masimo Radius PPG Radius PPG 3 Radius PPG Radius PPG Radius PPG Radius PPG Radius PPG Radius PPG Masimo MX 7 14 8 x...

Страница 44: ...adius PPG ADT 30 kg Radius PPG PDT 10 50 kg Radius PPG INF 3 10 kg 10 20 kg Radius PPG NEO 3 kg 40 kg c 1 2 2 3 3a 3b 4 d 30 kg Adt 10 50 kg Pdt 1 4a 2 4b 3 4c 3 10 kg Inf 1 5a 2 5b 3 5c 3 kg Neo 1 6a...

Страница 45: ...3 2 Arms 1 Masimo SET CO 70 100 SpO2 2 Masimo SET CO 70 100 SpO2 1 2 cm 2 4 Hz 2 3 cm 1 5 Hz 3 Masimo SET Biotek Index 2 Masimo 0 02 5 70 100 4 Masimo SET 25 240 Biotek Index 2 Masimo 0 02 5 70 100 5...

Страница 46: ...MM DD X LED NON STERILE LATEX 40 C 70 C 1060 hPa 500 hPa 795 mmHg 375 mmHg 5 95 RH 5 95 LATEX PCX 2108A 02 13 Bluetooth 12 5 mm 15 FCC http www Masimo com TechDocs http www masimo com patents htm Rad...

Страница 47: ...austuloksia ja voivat johtaa paineen aiheuttamaan kuolioon V rin asetetut tai osittain irronneet anturit voivat aiheuttaa virheellisi mittaustuloksia V r st anturityypist johtuvat asetusvirheet voivat...

Страница 48: ...Katso kuva 5a 2 K ri teippik re varpaan ymp ri siten ett l hetin tulee isovarpaan kynnen p lle Tarkkojen tietojen saaminen edellytt ett tunnistinikkuna peittyy kokonaan Katso kuva 5b 3 Varmista ett l...

Страница 49: ...ist n kosteus S ilytyksen kuljetuksen kosteus 5 95 kondensoimaton Toimintakosteus 5 95 kondensoimaton AKUN KESTOIK Akun kestoik 96 tuntia normaalissa jatkuvassa k yt ss YHTEENSOPIVUUS T m anturi on ta...

Страница 50: ...diodi LED LED tuottaa valoa kun s hk virta kulkee sen l pi X S ilytysl mp tilan vaihtelualue S rkyv k sittele varoen Suurempi kuin Pidett v kuivana NON STERILE LATEX 40 C 70 C 1060 hPa 500 hPa 795 mm...

Страница 51: ...Sensorer som er feil p satt eller delvis l snet kan gi un yaktige m linger Feil p f ring p grunn av feil sensortype kan f re til un yaktige m linger eller ingen m linger Ven s stuvning kan gi lavere...

Страница 52: ...st Se figur 5a 2 Fold det selvklebende omslaget rundt t en slik at senderen er plassert p neglesengen til stort en Detektorvinduet m dekkes helt for sikre n yaktige m leverdier Se figur 5b 3 P se at s...

Страница 53: ...Batterilevetid 96 timer ved typisk kontinuerlig bruk KOMPATIBILITET Denne sensoren skal kun brukes sammen med instrumenter utstyrt med Masimo SET oksymetri eller pulsoksymetrimonitorer som er lisensie...

Страница 54: ...sender ut lys n r det g r str m gjennom den Lagringstemperaturomr de Skj rt m behandles med forsiktighet St rre enn M holdes t rt NON STERILE LATEX 40 C 70 C 1060 hPa 500 hPa 795 mmHg 375 mmHg 5 95 R...

Страница 55: ...sn p ipevn n senzory nebo senzory kter t sn p il haj kv li vznikl mu ed mu m nep esn a mohou tak zp sobit tlakovou nekr zu Nespr vn um st n senzory nebo senzory kter ste n zm nily polohu mohou v st k...

Страница 56: ...c man etu kolem prstu na noze tak aby byl sv teln zdroj um st n na l ku nehtu palce na noze P esn data lze z skat pouze pokud je ok nko detektoru zcela zakryto Postupujte podle obr 5b 3 Ujist te se e...

Страница 57: ...t ed Provozn teplota 0 40 C p i vlhkosti okoln ho prost ed Skladovac p epravn vlhkost 5 95 nekondenzuj c Provozn vlhkost 5 95 nekondenzuj c KAPACITA BATERIE Kapacita baterie 96 hodin p i typick m nep...

Страница 58: ...pou it do RRRR MM DD X Sv teln dioda LED LED vyza uje sv tlo kdy j prot k proud Rozsah skladovac teploty K ehk opatrn manipulace V ce ne Uchov vejte v suchu NON STERILE LATEX 40 C 70 C 1060 hPa 500 h...

Страница 59: ...elyhez ez ronthatja a v r raml st s pontatlan eredm nyekhez vezethet A k l n ragaszt szalag haszn lata k ros thatja a b rt s az rz kel t s vagy nyom s okozta sz vetelhal st okozhat A t l szorosan felh...

Страница 60: ...sa az rz kel vezet k t gy hogy a l bh t tetej n fusson v gig Helyezze a vev t a nagyl bujj legnagyobb sz vetvastags g r sz re vagyis az ujjp rn ra M sik megold sk nt a nagyl bujj melletti ujj vagy a k...

Страница 61: ...tiple observations per individual Journal of Biopharmaceutical Statistics 2007 vol 17 pp 571 582 K RNYEZETI JELLEMZ K Sz ll t si t rol si h m rs klet 0 50 C k rnyezeti p ratartalom mellett M k d si h...

Страница 62: ...rvos ltal vagy orvosi rendelv nyre rt kes thet Tov bbi inform ci k rt l sd a haszn lati utas t st T telk d Az orvostechnikai eszk z kr l sz l 93 42 EGK ir nyelvnek val megfelel s jele Gy rt Katal guss...

Страница 63: ...saturacja krwi t tniczej tlenem Czujnika nie nale y mocowa w miejscu pomiaru za pomoc ta my poniewa mo e to ograniczy przep yw krwi i spowodowa niedok adne odczyty Zastosowanie dodatkowej ta my mo e...

Страница 64: ...obacz ryc 4b 3 Po prawid owym za o eniu emiter i detektor powinny by wyr wnane w pionie czarne linie powinny by wyr wnane W razie potrzeby poprawi Zobacz ryc 4c Inf czujnik dla NIEMOWL T 3 10 kg 1 Ski...

Страница 65: ...echowywania transportu Od 0 C do 50 C przy wilgotno ci otoczenia Temperatura podczas pracy Od 0 C do 40 C przy wilgotno ci otoczenia Wilgotno podczas przechowywania transportu 5 95 bez kondensacji Wil...

Страница 66: ...i Kod serii Oznaczenie zgodno ci z europejsk dyrektyw 93 42 EWG dotycz c urz dze medycznych Producent Numer katalogowy numer modelu Autoryzowany przedstawiciel na terenie Wsp lnoty Europejskiej Data p...

Страница 67: ...iza i band adeziv pentru a fixa senzorul n locul monitoriz rii acest lucru poate restric iona circula ia sanguin i poate duce la valori m surate inexacte Utilizarea de band adeziv suplimentar poate du...

Страница 68: ...l p r ii superioare a labei Pozi iona i detectorul pe partea c rnoas a degetului mare de la picior Ca alternativ se poate aplica pe degetul al turat celui mare de la picior sau pe degetul mare de la m...

Страница 69: ...multiple observations per individual Journal of Biopharmaceutical Statistics 2007 vol 17 pp 571 582 CARACTERISTICI DE MEDIU Temperatur de depozitare transport ntre 0 C i 50 C la umiditate ambiant Temp...

Страница 70: ...odul lotului Marc de conformitate cu Directiva european pentru dispozitive medicale 93 42 CEE Produc tor Num r de catalog num r model Reprezentant autorizat n Comunitatea European Data fabrica iei AAA...

Страница 71: ...nebud mera presne a m u sp sobi tlakov nekr zu Nespr vne nasadenie senzora alebo jeho iasto n posunutie m e sp sobi nespr vne hodnoty meran Pou itie nespr vneho typu senzora m e sp sobi e sa odpo ty z...

Страница 72: ...vnu man etu zahnite okolo palca na nohe tak aby bol emitor umiestnen na nechtovom l ku palca na nohe Na zabezpe enie presn ch dajov je potrebn pln prekrytie okienka detektora Pozrite si obr 5b 3 Uist...

Страница 73: ...ivotnos bat rie 96 hod n pri typickom nepretr itom pou van KOMPATIBILITA Tento senzor je ur en na pou itie iba so zariadeniami vybaven mi oxymetrickou technol giou Masimo SET alebo s monitorovac mi p...

Страница 74: ...uj ca svetlo LED LED vy aruje svetlo ke ou pretek pr d Rozsah skladovac ch tepl t Krehk manipulujte opatrne Viac ako Uchov vajte v suchu NON STERILE LATEX 40 C 70 C 1060 hPa 500 hPa 795 mmHg 375 mmHg...

Страница 75: ...bas n nekrozuna neden olabilir Yanl uygulanm sens rler veya k smen yerinden oynayan sens rler hatal l mlere yol a abilir Yanl sens r tiplerinden kaynaklanan yanl uygulamalar hatal de erlere veya de er...

Страница 76: ...ayak ba parma n n t rnak yata n n zerinde olacak ekilde yap kanl sarg y parma n etraf na sar n Verilerin do ru olmas n sa lamak i in detekt r penceresinin tamamen kaplanmas gerekir Bkz ekil 5b 3 Yay...

Страница 77: ...u sens r yaln zca Masimo SET oksimetrisini i eren cihazlar veya Masimo sens rlerin kullan m i in lisansl olan nab z oksimetrisi monit rleri ile birlikte kullan m i in tasarlanm t r Radius PPG sens rle...

Страница 78: ...ans numaras V cut a rl Son kullan m tarihi YYYY AA GG X I k Yayan Diyotlar LED Ak m ak ger ekle ti inde LED k yayar Saklama s cakl aral K r l r dikkatli ta y n B y kt r Kuru tutun NON STERILE LATEX 40...

Страница 79: ...795 mmHg 375 mmHg 5 95 RH 5 95 Radius PPG Radius PPG Masimo SpO2 PR Radius PPG Masimo SpO2 PR Masimo Masimo Radius PPG Radius PPG Radius PPG Radius PPG Radius PPG Radius PPG Radius PPG Radius PPG Mas...

Страница 80: ...dius PPG Radius PPG ADT 30 kg Radius PPG PDT 10 50 kg Radius PPG INF 3 10 kg 10 20 kg Radius PPG NEO 3 kg 40 kg 1 2 2 3 3a 3b 4 Adt 30 kg Pdt 10 50 kg 1 4a 2 4b 3 4c Inf 3 10 kg 1 5a 2 5b 3 5c Neo 3 k...

Страница 81: ...91 Arms Arms 1 Masimo SET 70 100 SpO2 CO 2 Masimo SET 2 4 Hz 1 2 cm 1 5 Hz 2 3 cm 70 100 SpO2 CO 3 Masimo SET Biotek Index 2 Masimo 0 02 5 70 100 4 Masimo SET 25 240 Biotek Index 2 Masimo 0 02 5 70 1...

Страница 82: ...LED NON STERILE LATEX 40 C 70 C 1060 hPa 500 hPa 795 mmHg 375 mmHg 5 95 RH 5 95 LATEX PCX 2108A 02 13 Bluetooth 12 5 mm 15 FCC http www Masimo com TechDocs http www masimo com patents htm Radius PPG M...

Страница 83: ...795 mmHg 375 mmHg 5 95 RH 5 95 Radius PPG Radius PPG Masimo SpO2 PR Radius PPG Masimo SpO2 PR Masimo Masimo Radius PPG Radius PPG Radius PPG Radius PPG Radius PPG Radius PPG Radius PPG Radius PPG Mas...

Страница 84: ...PG C Radius PPG D Radius PPG Radius PPG ADT 30 Radius PPG PDT 10 50 Radius PPG INF 3 10 10 20 Radius PPG NEO 3 40 1 2 2 3 3a 3b 4 Adt 30 Pdt 10 50 1 4a 2 4b 3 4c Inf 3 10 1 5a 2 5b 3 5c Neo 3 1 6a 2 6...

Страница 85: ...LoA 2 91 Arms Arms 1 Masimo SET 70 100 SpO2 CO 2 Masimo SET 2 4 1 2 1 5 2 3 70 100 SpO2 CO 3 Masimo SET Biotek Index 2 Masimo 0 02 5 70 100 4 Masimo SET 25 240 Biotek Index 2 Masimo 0 02 5 70 100 5 1...

Страница 86: ...42 EEC Masimo X NON STERILE LATEX 40 C 70 C 1060 hPa 500 hPa 795 mmHg 375 mmHg 5 95 RH 5 95 LATEX PCX 2108A 02 13 Bluetooth 12 5 15 FCC http www Masimo com TechDocs http www masimo com patents htm Rad...

Страница 87: ...5 95 RH 5 95 Radius PPG Masimo Radius PPG SpO2 PR Masimo Radius PPG SpO2 PR Masimo Masimo Radius PPG Radius PPG Radius PPG Radius PPG Radius PPG Radius PPG Radius PPG Radius PPG Masimo MX 7 14 8 x 1 S...

Страница 88: ...b Radius PPG ADT 30kg Radius PPG PDT 10 50kg Radius PPG INF 3 10kg 10 20kg Radius PPG NEO 3kg 40kg c 1 1 2 2 3 3a 3b 4 d Adt 30kg Pdt 10 50kg 1 4a 2 4b 3 4c Inf 3 10kg 1 5a 2 5b 3 5c Neo 3kg 1 6a 2 6b...

Страница 89: ...95 LoA 2 91 Arms 2 3 Arms 1 Masimo SET SpO2 70 100 CO 2 Masimo SET SpO2 70 100 1 2cm 2 4Hz 2 3cm 1 5Hz CO 3 Masimo SET 70 100 0 02 5 Biotek Index 2 Masimo 4 Masimo SET 25 240bpm 70 100 0 02 5 Biotek I...

Страница 90: ...Masimo YYYY MM DD X LED LED NON STERILE LATEX 40 C 70 C 1060 hPa 500 hPa 795 mmHg 375 mmHg 5 95 RH 5 95 LATEX PCX 2108A 02 13 Bluetooth 15 12 5mm 1 FCC http www Masimo com TechDocs eIFU http www masim...

Страница 91: ...DD X LED LED NON STERILE LATEX 40 C 70 C 1060 hPa 500 hPa 795 mmHg 375 mmHg 5 95 RH 5 95 LATEX PCX 2108A 02 13 Bluetooth 12 5 15 FCC http www Masimo com TechDocs http www masimo com patents htm Masim...

Страница 92: ...Arms Arms Masimo SET 1 SpO2 100 70 Masimo SET 2 3 2 5 1 2 1 4 2 SpO2 100 70 5 0 02 Masimo Biotek Index 2 Masimo SET 3 100 70 0 02 Masimo Biotek Index 2 240 25 Masimo SET 4 100 70 5 1 5 Agreement betw...

Страница 93: ...dius PPG ADT 50 10 Radius PPG PDT 20 10 10 3 Radius PPG INF 40 3 Radius PPG NEO 1 1 2 2 2 3 3 3b 3a 4 4 50 10 Pdt 30 Adt 1 1 4a 2 2 4b 3 3 4c 10 3 Inf 1 1 5a 2 2 5b 3 3 5c 3 Neo 1 1 6a 2 2 6b 3 3 6c 2...

Страница 94: ...mHg 5 95 RH 5 95 Radius PPG PR SpO2 Masimo Radius PPG PR SpO2 Masimo Radius PPG Masimo Masimo Radius PPG Radius PPG Radius PPG Radius PPG Radius PPG Radius PPG Radius PPG 7 14 8 x MX Masimo Radius PPG...

Страница 95: ...0 1 14 1 14 80 90 1 29 1 29 70 80 1 41 1 41 70 100 1 33 1 33 SpO2 Upper and Lower Limits of Agreement LoA Actual Value Upper 95 LoA 1 98 Lower 95 LoA 2 91 See Bland and Altman Agreement between method...

Страница 96: ...Corporation Masimo Corporation 52 Discovery Irvine CA 92618 USA www masimo com Manufacturer EU Authorized Representative for Masimo Corporation MDSS GmbH Schiffgraben 41 D 30175 Hannover Germany 1035...

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