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5

9022B-eIFU-0119

SPECIFICATIONS

The RD DBI sensors have the following specifications:

RD SET DBI Sensor

Masimo SET Technology

Nellcor Technology

 Body Weight

> 30 kg

> 30 kg

Application Site

Middle or Ring Finger

Middle or Ring Finger

SpO

2

 Accuracy, No Motion

2%

1

2%

4

SpO

2

 Accuracy, Low Perfusion

2%

2

--

Pulse Rate Accuracy, No Motion

3 bpm

3

3 bpm

4

Pulse Rate Accuracy, Low Perfusion

3 bpm

3

--

NOTE: 

A

rms

 accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-

thirds of the device measurements fell within ± 

A

rms

 of the reference measurements in a controlled study.

1

 The Masimo SET technology has been validated for no motion accuracy in human blood studies on healthy adult male and female volunteers with light 

to dark pigmented skin in induced hypoxia studies in the range of 70–100% SpO

2

 against a laboratory CO-Oximeter. 

2

 The Masimo SET technology has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo’s 

simulator with signal strengths of greater than 0.02% and transmission of greater than 5% for saturations ranging from 70% to 100%. 

3

 The Masimo SET technology has been validated for pulse rate accuracy for the range of 25–240 bpm in bench top testing against a Biotek Index 2 

simulator and Masimo’s simulator with signal strengths of greater than 0.02% and transmission of greater than 5% for saturations ranging from 70% 

to 100%.

4

 Not validated for Motion and Low Perfusion accuracy using Nellcor Technology.

COMPATIBILITY

This sensor is intended for use only with devices containing Masimo SET oximetry or pulse oximetry monitors licensed to use RD SET 

sensors. Each sensor is designed to operate correctly only on the pulse oximetry systems from the original device manufacturer. Use of 

this sensor with other devices may result in no or improper performance.
For Compatibility Information Reference: www.Masimo.com

ENVIRONMENTAL

Operating Temperature

41°F to 104°F (5°C to 40°C)

Storage Temperature

-40°F to 158°F (-40°C to 70°C)

Relative Humidity

10% to 95% noncondensing

WARRANTY

Masimo warrants to the initial buyer only that this product, when used in accordance with the directions provided with the Products by Masimo, 

will be free of defects in materials and workmanship for a period of six (6) months. Single use products are warranted for single patient use only. 
THE FOREGOING IS THE SOLE AND EXCLUSIVE WARRANTY APPLICABLE TO THE PRODUCTS SOLD BY MASIMO TO BUYER. MASIMO EXPRESSLY 

DISCLAIMS ALL OTHER ORAL, EXPRESS OR IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION ANY WARRANTIES OF MERCHANTABILITY 

OR FITNESS FOR PARTICULAR PURPOSE. MASIMO’S SOLE OBLIGATION AND BUYER’S EXCLUSIVE REMEDY FOR BREACH OF ANY WARRANTY 

SHALL BE, AT MASIMO’S OPTION, TO REPAIR OR REPLACE THE PRODUCT.

WARRANTY EXCLUSIONS

This warranty does not extend to any product that has been used in violation of the operating instructions supplied with the product, or has been 

subject to misuse, neglect, accident or externally created damage. This warranty does not extend to any product that has been connected to any 

unintended device or system, has been modified, or has been disassembled or reassembled. This warranty does not extend to sensors or patient 

cables that have been reprocessed, reconditioned or recycled.
IN NO EVENT SHALL MASIMO BE LIABLE TO BUYER OR ANY OTHER PERSON FOR ANY INCIDENTAL, INDIRECT, SPECIAL OR CONSEQUENTIAL 

DAMAGES (INCLUDING WITHOUT LIMITATION LOST PROFITS), EVEN IF ADVISED OF THE POSSIBILITY THEREOF. IN NO EVENT SHALL MASIMO’S 

LIABILITY ARISING FROM ANY PRODUCTS SOLD TO BUYER (UNDER A CONTRACT, WARRANTY, TORT OR OTHER CLAIM) EXCEED THE AMOUNT 

PAID BY BUYER FOR THE LOT OF PRODUCT(S) INVOLVED IN SUCH CLAIM. IN NO EVENT SHALL MASIMO BE LIABLE FOR ANY DAMAGES 

ASSOCIATED WITH A PRODUCT THAT HAS BEEN REPROCESSED, RECONDITIONED OR RECYCLED. THE LIMITATIONS IN THIS SECTION SHALL 

NOT BE DEEMED TO PRECLUDE ANY LIABILITY THAT, UNDER APPLICABLE PRODUCTS LIABILITY LAW, CANNOT LEGALLY BE PRECLUDED BY 

CONTRACT.

NO IMPLIED LICENSE

PURCHASE OR POSSESSION OF THIS SENSOR CONFERS NO EXPRESS OR IMPLIED LICENSE TO USE THE SENSOR WITH ANY DEVICE WHICH IS 

NOT SEPARATELY AUTHORIZED TO USE RD SET DBI SENSORS.

Содержание RD SET

Страница 1: ...19 22 sv Swedish 23 26 nl Dutch 27 30 da Danish 31 34 pt Portuguese 35 38 zh Chinese 39 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 R...

Страница 2: ...2 9022B eIFU 0119 RD SET DBI Reusable Soft Sensors Fig 3 Fig 6 Fig 4 Fig 5 Fig 1 Fig 2...

Страница 3: ...nsor is not frequently moved applied too tightly or becomes too tight due to edema Assess site as frequently as every 1 hour and move the sensor if there are signs of loss of skin integrity and or los...

Страница 4: ...is long it may extend through the opening at the end of the sensor Check the arrangement of the sensor to verify correct positioning Release the sides of the sensor Complete coverage of the detector i...

Страница 5: ...Storage Temperature 40 F to 158 F 40 C to 70 C Relative Humidity 10 to 95 noncondensing WARRANTY Masimo warrants to the initial buyer only that this product when used in accordance with the directions...

Страница 6: ...the European community Date of manufacture YYYY MM DD Masimo reference number Body weight Use by YYYY MM DD Storage humidity limitation Storage temperature range Do not discard Do not use if package...

Страница 7: ...e maintenir l int grit de la peau et de corriger l alignement optique Proc der avec pr caution si le capteur n est pas r guli rement d plac est trop serr ou devient trop serr cause d un d me une rosio...

Страница 8: ...st propre B Fixation du capteur au patient 1 Se reporter la fig 1 Tenir le capteur avec l toile et le c ble sur le dessus Ouvrir le capteur en appuyant sur ses c t s Ins rer le doigt s lectionn dans l...

Страница 9: ...ce capteur avec des appareils tiers risque de fausser les mesures voire d emp cher d effectuer les mesures Pour des r f rences sur les informations de compatibilit www Masimo com CARACT RISTIQUES ENVI...

Страница 10: ...Repr sentant agr dans l Union europ enne Date de fabrication AAAA MM JJ Num ro de r f rence Masimo Poids du patient Date de p remption AAAA MM JJ Limite d humidit de stockage Plage de temp rature de...

Страница 11: ...r Sch den aufweisen Brechen Sie die Anwendung ab wenn der Sensor verf rbt oder besch digt ist Besch digte Sensoren oder Sensoren bei denen elektrische Komponenten freiliegen d rfen nicht verwendet wer...

Страница 12: ...rtlaufend in einer Meldung auf geringe SIQ hingewiesen wird nachdem die in der Bedienungsanleitung des berwachungsger ts ausgewiesenen Fehlerbeseitigungsschritte bei geringer SIQ durchgef hrt wurden H...

Страница 13: ...ierung im Bereich von 70 100 SpO2 mit einem Labor CO Oximeter validiert 2 Die Genauigkeit bei schwacher Durchblutung wurde f r die Masimo SET Technologie durch Pr fstanduntersuchungen mit einem Biotek...

Страница 14: ...DIESES GER T NUR VON RZTEN ODER AUF DEREN ANORDNUNG HIN VERKAUFT WERDEN Zur professionellen Verwendung Vollst ndige Verschreibungsinformationen einschlie lich Indikationen Gegenanzeigen Warnungen Vor...

Страница 15: ...spesso o in base al protocollo clinico per garantire un adeguata circolazione l integrit della cute e un corretto allineamento ottico Prestare estrema attenzione se il sensore non viene spostato di fr...

Страница 16: ...e del sito Scegliere un sito che sia ben perfuso e che non limiti i movimenti di pazienti coscienti Il sito di elezione l anulare della mano non dominante Il sito deve essere pulito da detriti prima d...

Страница 17: ...to per funzionare correttamente solo sui sistemi di pulsossimetria fabbricati dal produttore originale del dispositivo L uso di un sensore con dispositivi non idonei pu compromettere le prestazioni Pe...

Страница 18: ...resentante autorizzato nella Comunit Europea Data di fabbricazione AAAA MM GG Numero di riferimento Masimo Peso corporeo Data di scadenza AAAA MM GG Limitazione dell umidit di conservazione Intervallo...

Страница 19: ...s como la alineaci n ptica correcta Deben adoptarse precauciones extremas cuando el sensor no se mueve con frecuencia se coloca demasiado ajustado o se aprieta a causa de un edema puede producirse ero...

Страница 20: ...Antes de colocar el sensor se deber limpiar el sitio para que est libre de suciedad B Colocaci n del sensor en el paciente 1 Consulte la Fig 1 Sostenga el sensor de modo que la estrella y el cable qu...

Страница 21: ...rendimiento inadecuado o impedir su funcionamiento Para obtener informaci n de referencia acerca de la compatibilidad consulte www Masimo com ASPECTOS AMBIENTALES Temperatura de funcionamiento 41 F a...

Страница 22: ...lo Representante autorizado en la Comunidad Europea Fecha de fabricaci n AAAA MM DD N mero de referencia de Masimo Peso corporal Fecha de caducidad AAAA MM DD L mite de humedad de almacenamiento Rango...

Страница 23: ...f r att s kerst lla att cirkulationen r tillr cklig huden r oskadad och den optiska inriktningen r korrekt Iaktta yttersta f rsiktighet Hudnedbrytning v vnadsischemi och eller trycknekros kan uppst om...

Страница 24: ...ig 2 Rikta in sensorn s att kabeln l per p ovansidan av patientens hand Fingrets topp ska nudda vid det upph jda fingerstoppet inuti sensorns underdel Om fingernageln r l ng kan den n genom ppningen i...

Страница 25: ...rvaringstemperatur 40 C till 70 C 40 F till 158 F Relativ luftfuktighet 10 till 95 icke kondenserande GARANTI Masimo garanterar endast den ursprungliga k paren att denna produkt n r den anv nds enligt...

Страница 26: ...erad representant inom EU Tillverkningsdatum MM DD Masimos referensnummer Kroppsvikt Anv nds senast MM DD Luftfuktighetsbegr nsning vid f rvaring F rvaringstemperaturomr de Kassera inte Anv nd inte om...

Страница 27: ...goede circulatie huidconditie en optische uitlijning Wees uiterst voorzichtig huiderosie weefselischemie en of druknecrose kunnen ontstaan als de sensor niet vaak genoeg wordt verplaatst te strak is b...

Страница 28: ...ts die goed doorbloed is en de bewegingen van een bij bewustzijn zijnde pati nt het minst beperkt De ringvinger van de niet dominante hand heeft de voorkeur De plaats moet helemaal schoon zijn voordat...

Страница 29: ...nkelijke fabrikant Het is mogelijk dat deze sensor niet of onjuist functioneert bij gebruik in combinatie met andere apparaten Ga voor meer informatie over compatibiliteit naar www Masimo com OMGEVING...

Страница 30: ...e Europese Gemeenschap Productiedatum JJJJ MM DD Referentienummer Masimo Lichaamsgewicht Houdbaarheidsdatum JJJJ MM DD Vochtigheidsgraadlimieten bij opslag Opslagtemperatuurbereik Niet wegwerpen Niet...

Страница 31: ...sigtighed Der kan opst huderosion v vsisk mi og eller tryknekrose hvis sensoren ikke flyttes regelm ssigt sidder for stramt eller bliver for stram p grund af demer Kontroll r stedet s hyppigt som hver...

Страница 32: ...tens h ndryg Spidsen af fingeren skal r re det forh jede fingerstop i bunden af sensoren Hvis fingerneglen er lang kan den stikke ud gennem bningen i enden af sensoren Kontroll r at sensoren er placer...

Страница 33: ...tte produkt hvis det anvendes i henhold til anvisningerne som leveres af Masimo sammen med produkterne er fri for h ndv rksm ssige defekter eller materialefejl i en periode p seks 6 m neder For engang...

Страница 34: ...sdato MM DD Masimo referencenummer Kropsv gt Anvendes inden MM DD Begr nsning for luftfugtighed ved opbevaring Opbevaringstemperaturinterval M ikke kasseres M ikke anvendes hvis pakken er beskadiget O...

Страница 35: ...m circuitos el tricos expostos O local deve ser verificado frequentemente ou de acordo com o protocolo cl nico para assegurar uma circula o adequada a integridade da pele e um alinhamento tico correto...

Страница 36: ...de monitoriza o do paciente Substitua o sensor quando o tempo de monitoriza o do paciente estiver esgotado INSTRU ES A Sele o do local Escolha um local com uma boa perfus o e que limite o menos poss...

Страница 37: ...a para a utiliza o de sensores RD SET Cada sensor concebido para funcionar corretamente apenas nos sistemas de oximetria de pulso do fabricante do dispositivo original A utiliza o deste sensor com out...

Страница 38: ...93 42 CEE relativa a dispositivos m dicos simo Fabricante N mero de cat logo n mero do modelo Representante autorizado na Comunidade Europeia Data de fabrico AAAA MM DD N mero de refer ncia Masimo Pes...

Страница 39: ...g 5 95 RH 5 95 Masimo SET Masimo rainbow SET RD SET DBI SpO2 SpO2 Nellcor Nellcor Philips FAST SpO2 RD SET DBI SpO2 SpO2 RD SET DBI 4 RD SET DBI Masimo SET RD SET DBI Masimo rainbow SET RD SET DBI Nel...

Страница 40: ...Cal 8 760 A B 1 1 2 2 C 1 3 2 4 D 1 5 2 6 1 2 70 3 4 7 4 Metrex Metricide 28 Cidex 2250 ECOLAB Huntington Brand Aspeti Wipe 1 10 5 6 7 1 Metrex Metricide 28 Cidex 2250 ECOLAB Huntington Brand Aspeti W...

Страница 41: ...1 70 100 SpO2 Masimo SET 2 Biotek Index 2 Masimo 70 100 Masimo SET 0 02 5 Masimo SET 3 Biotek Index 2 Masimo 70 100 Masimo SET 0 02 5 Masimo SET 25 240 4 Nellcor Masimo SET RD SET www Masimo com 41F 1...

Страница 42: ...hics Sensor Cable symbols 03 06 GR 14231 DRO 13914 40 C 70 C 1060 hPa 500 hPa 795 mmHg 375 mmHg 5 95 RH 5 95 LATEX PCX 2108A 02 13 X LED LED http www Masimo com TechDocs http www masimo com patents ht...

Страница 43: ...500 hPa 795 mmHg 375 mmHg 5 95 RH 5 95 Masimo SET Masimo rainbow SET RD SET DBI SpO2 SpO2 Nellcor Nellcor Philips FAST SpO2 RD SET DBI SpO2 SpO2 RD SET DBI 4 RD SET DBI Masimo SET RD SET DBI Masimo ra...

Страница 44: ...pO2 SpO2 SpO2 SpO2 Masimo SIQ SIQ X Cal 8 760 A B 1 1 2 2 C 1 3 2 4 D 1 5 2 6 1 2 70 3 4 7 4 Metrex Metricide 28 Cidex 2250 ECOLAB Huntington Brand Aspeti Wipe 1 10 5 6 7 1 Metrex Metricide 28 Cidex 2...

Страница 45: ...bpm3 Arms 3 2 Arms 1 Masimo SET CO 70 100 SpO2 2 Masimo SET Biotek Index 2 Masimo 70 100 0 02 5 3 Masimo SET Biotek Index 2 Masimo 25 240 bpm 70 100 0 02 5 4 Nellcor Masimo SET RD SET www Masimo com...

Страница 46: ...Graphics Sensor Cable symbols 03 06 GR 14231 DRO 13914 40 C 70 C 1060 hPa 500 hPa 795 mmHg 375 mmHg 5 95 RH 5 95 LATEX PCX 2108A 02 13 X LED http www Masimo com TechDocs http www masimo com patents ht...

Страница 47: ...nturi on kiinnitetty liian tiukasti sen kiinnitys tiukentuu turvotuksen vuoksi tai sen paikkaa ei vaihdeta riitt v n usein seurauksena voi olla ihon hankautuminen kudosiskemia ja tai paineen aiheuttam...

Страница 48: ...uriin 2 Katso kuva 2 Suuntaa anturi niin ett kaapeli kulkee potilaan k mmenselk kohti Sormenp n tulee koskettaa anturissa sen pohjalla olevaa koroketta joka est sormen ty nt misen liian syv lle Jos ky...

Страница 49: ...www Masimo com YMP RIST K ytt l mp tila 5 40 C 41 104 F S ilytysl mp tila 40 70 C 40 158 F Suhteellinen kosteus 10 95 tiivistym t n TAKUU Masimo my nt alkuper iselle ostajalle kuuden 6 kuukauden taku...

Страница 50: ...nissa Valmistusp iv VVVV KK PP Masimon viitenumero Paino K ytett v viimeist n VVVV KK PP S ilytyskosteusrajoitus S ilytysl mp tilan vaihtelualue l h vit l k yt jos pakkaus on vaurioitunut Pidett v kui...

Страница 51: ...soren ikke flyttes ofte er p f rt for stramt eller blir for stram p grunn av dem Vurder stedet s ofte som hver 1 time og flytt sensoren hvis det forekommer tegn p at huden mister integritet og eller a...

Страница 52: ...r re det hevede fingerstoppet i bunnen av sensoren Hvis fingerneglen er lang kan den g gjennom pningen i enden av sensoren Kontroller at sensoren er riktig plassert L sne sidene p sensoren Detektoren...

Страница 53: ...nterer overfor den opprinnelige kj peren at dette produktet n r det brukes i henhold til instruksjonene som f lger med produktene fra Masimo vil v re fritt for material og produksjonsfeil i en periode...

Страница 54: ...to MM DD Masimo referansenummer Kroppsvekt Brukes innen MM DD Fuktighetsbegrensning ved lagring Lagringstemperaturomr de M ikke kastes M ikke brukes dersom emballasjen er skadet M holdes t rt Skj rt m...

Страница 55: ...i opatrn Pokud nen senzor asto p emis ov n je nasazen p li t sn nebo t sn p il h kv li vznikl mu ed mu m e doj t ke vzniku ko n ch eroz tk ov ischemie nebo tlakov nekr zy M sto aplikace kontrolujte ka...

Страница 56: ...nta pi ka prstu by se m la dot kat vyv en zar ky uvnit senzoru dole Pokud m pacient dlouh nehet m ete jej prot hnout otvorem na konci senzoru Ov te spr vnou pozici senzoru Uvoln te strany senzoru P es...

Страница 57: ...teplota 40 C a 70 C 40 F a 158 F Relativn vlhkost 10 a 95 bez kondenzace Z RUKA Spole nost Masimo poskytuje z ruku pouze p vodn mu kupuj c mu tohoto produktu a to pouze pokud je produkt pou v n v soul...

Страница 58: ...tum v roby RRRR MM DD Referen n slo spole nosti Masimo T lesn hmotnost K pou it do RRRR MM DD Omezen skladovac vlhkosti Rozsah skladovac teploty Nelikvidujte spole n s b n m odpadem Nepou vejte pokud...

Страница 59: ...Alapos k r ltekint s sz ks ges nem elegend mozgat s t l szoros felhelyez s vagy d ma miatti t lzott szoross g eset n az rz kel b rer zi t sz veti v rell t si zavart s vagy nyom s okozta sz vetelhal s...

Страница 60: ...betegen 1 L sd az 1 br t Tartsa az rz kel t gy hogy a csillag s a vezet k fel l legyen Nyissa ki az rz kel t gy hogy benyomja az rz kel oldalait Helyezze a kiv lasztott ujjat az rz kel be 2 L sd a 2...

Страница 61: ...klet 5 C s 40 C 41 F s 104 F k z tt T rol si h m rs klet 40 C s 70 C 40 F s 158 F k z tt Relat v p ratartalom 10 95 nem lecsap d J T LL S A Masimo kiz r lag az els vev sz m ra garant lja hogy ez a te...

Страница 62: ...t pussz m Meghatalmazott k pvisel az Eur pai K z ss gben Gy rt s d tuma HH NN Masimo hivatkoz si sz m Testt meg Lej rat HH NN T rol si p ratartalomra vonatkoz korl toz s T rol si h m rs klet tartom n...

Страница 63: ...jnika uszkodzonego lub z ods oni tymi obwodami elektrycznymi W celu zapewnienia odpowiedniego kr enia ci g o ci sk ry i prawid owego u o enia optycznego miejsce nale y sprawdza cz sto lub zgodnie z pr...

Страница 64: ...Uwaga Czujnik jest dostarczany z technologi X Cal kt ra minimalizuje ryzyko uzyskania niedok adnych odczyt w i nieoczekiwanej przerwy w monitorowaniu pacjenta Czujnik zapewnia do 8760 godzin monitorow...

Страница 65: ...sowania wy cznie z urz dzeniami wyposa onymi w funkcj oksymetrii Masimo SET lub monitorami pulsoksymetrii licencjonowanymi do stosowania czujnik w RD SET Ka dy czujnik jest zaprojektowany do prawid ow...

Страница 66: ...cenie lekarza Zapozna si z instrukcj obs ugi Kod serii Oznaczenie zgodno ci z europejsk dyrektyw 93 42 EWG dotycz c urz dze medycznych mo Producent Numer katalogowy numer modelu Autoryzowany przedstaw...

Страница 67: ...nul care are circuitele electrice expuse Locul trebuie verificat frecvent sau conform protocolului clinicii pentru a v asigura de corectitudinea circula iei de integritatea pielii i de alinierea optic...

Страница 68: ...e limiteaz cel mai pu in mi c rile unui pacient con tient De preferat ar fi inelarul m inii care nu este dominant Locul n care va fi aplicat senzorul trebuie cur at n prealabil B Aplicarea senzorului...

Страница 69: ...e dispozitive poate mpiedica func ionarea sau poate determina o func ionare necorespunz toare Pentru informa ii referitoare la compatibilitate accesa i site ul www Masimo com CARACTERISTICI DE MEDIU T...

Страница 70: ...iei AAAA LL ZZ Num rul de referin Masimo Greutate corporal A se utiliza p n la AAAA LL ZZ Limite umiditate de depozitare Interval temperatur de depozitare A nu se arunca A nu se utiliza dac ambalajul...

Страница 71: ...isov kontrolova aby sa zaru il dostato n krvn obeh celistvos poko ky a opticky spr vna poloha Postupujte s mimoriadne zv enou pozornos ou ak sa senzor asto nepremiest uje je aplikovan ve mi natesno al...

Страница 72: ...by sa malo zvolen miesto o isti od ne ist t B Nasadenie senzora pacientovi 1 Pozrite si obr 1 Senzor dr te tak aby boli hviezdi ka a k bel hore Senzor roztvorte zatla en m na jeho boky Zvolen prst vl...

Страница 73: ...funk nos pr padne nefunk nos Inform cie o kompatibilite n jdete na adrese www Masimo com PODMIENKY PROSTREDIA Prev dzkov teplota 5 C a 40 C 41 F a 104 F Skladovacia teplota 40 C a 70 C 40 F a 158 F R...

Страница 74: ...olo enstve D tum v roby RRRR MM DD Referen n slo spolo nosti Masimo Telesn hmotnos Pou ite do RRRR MM DD Obmedzenie vlhkosti pri skladovan Rozsah skladovacej teploty Nezahadzujte Nepou vajte ak je bal...

Страница 75: ...lt erozyonu doku iskemisi ve veya bas n nekrozu meydana gelebilir bu nedenle ok dikkatli olun Cilt b t nl nde bozulma ve veya dola m ya da perf zyon kayb belirtileri varsa giri b lgesini her 1 saat ba...

Страница 76: ...r lm parmak tamponuna dokunmal d r T rnak uzunsa sens r n ucundaki a kl ktan uzat labilir Sens r n konumunun do ru oldu undan emin olmak i in sens r n yerle imini kontrol edin Sens r n yan k s mlar n...

Страница 77: ...8 F Ba l Nem 10 ila 95 yo u mas z GARANT Masimo Masimo r nleriyle birlikte temin edilen talimatlara uygun ekilde kullan lmas art yla yaln zca ilk al c i in bu r n n alt 6 ayl k bir s re zarf nda malze...

Страница 78: ...aras Avrupa toplulu undaki yetkili temsilci retim tarihi YYYY AA GG Masimo referans numaras V cut a rl Son kullan m tarihi YYYY AA GG Saklama nem s n r Saklama s cakl aral Atmay n Paket zarar g rm se...

Страница 79: ...40 C 70 C 1060 hPa 500 hPa 795 mmHg 375 mmHg 5 95 RH 5 95 Masimo SET Masimo rainbow SET RD SET DBI SpO2 SpO2 Nellcor Nellcor Philips FAST SpO2 RD SET DBI SpO2 SpO2 RD SET DBI 4 RD SET DBI Masimo SET...

Страница 80: ...SpO2 COHb MetHb CO COHb SpO2 MetHb SpO2 SpO2 SpO2 s Hbs c Hbc SpO2 SpO2 Raynaud SpO2 SpO2 Masimo SIQ SIQ X Cal 8 760 A B 1 1 2 2 1 3 2 4 1 5 2 6 1 2 70 3 4 7 4 Metrex Metricide 28 Cidex 2250 ECOLAB H...

Страница 81: ...o SET Nellcor 30 kg 30 kg SpO2 2 1 2 4 SpO2 2 2 3 bpm3 3 bpm4 3 bpm3 Arms Arms 1 Masimo SET 70 100 SpO2 CO 2 Masimo SET Biotek Index 2 Masimo 0 02 5 70 100 3 Masimo SET 25 240 bpm Biotek Index 2 Masim...

Страница 82: ...hics Sensor Cable symbols 03 06 GR 14231 DRO 13914 40 C 70 C 1060 hPa 500 hPa 795 mmHg 375 mmHg 5 95 RH 5 95 LATEX PCX 2108A 02 13 X LED LED http www Masimo com TechDocs http www masimo com patents ht...

Страница 83: ...3914 40 C 70 C 1060 hPa 500 hPa 795 mmHg 375 mmHg 5 95 RH 5 95 Masimo SET Masimo rainbow SET RD SET DBI SpO2 SpO2 Nellcor Pulse Oximeter Philips FAST SpO2 RD SET DBI SpO2 SpO2 RD SET DBI 4 RD SET DBI...

Страница 84: ...MetHb SpO2 COHb MetHb CO COHb SpO2 MetHb SpO2 SpO2 SpO2 Hb s Hb c SpO2 SpO2 SpO2 SpO2 Masimo X Cal 8760 A 1 1 2 2 1 3 2 4 1 5 2 6 1 2 70 3 4 7 4 Metrex Metricide 28 Cidex 2250 ECOLAB Huntington Brand...

Страница 85: ...I Masimo SET Nellcor 30 30 SpO2 2 1 2 4 SpO2 2 2 3 3 3 4 3 3 Arms Arms 1 Masimo SET 70 100 SpO2 CO 2 Masimo SET Biotek Index 2 Masimo 0 02 5 70 100 3 Masimo SET 25 240 Biotek Index 2 Masimo 0 02 5 70...

Страница 86: ...tle Graphics Sensor Cable symbols 03 06 GR 14231 DRO 13914 40 C 70 C 1060 hPa 500 hPa 795 mmHg 375 mmHg 5 95 RH 5 95 LATEX PCX 2108A 02 13 X http www Masimo com TechDocs http www masimo com patents ht...

Страница 87: ...Hg 375 mmHg 5 95 RH 5 95 Masimo SET Masimo rainbow SET RD SET DBI SpO2 SpO2 Nellcor Nellcor Philips FAST SpO2 RD SET DBI SpO2 SpO2 RD SET DBI 4 RD SET DBI Masimo SET RD SET DBI Masimo rainbow SET RD S...

Страница 88: ...IQ X Cal 8 760 A B 1 1 2 2 C 1 3 2 4 D 1 5 2 6 1 2 70 3 4 7 4 Metrex Metricide 28 Cidex 2250 ECOLAB Huntington Brand Aspeti Wipe 1 10 5 6 7 1 Metrex Metricide 28 Cidex 2250 ECOLAB Huntington Brand Asp...

Страница 89: ...1 Masimo SET 70 100 SpO2 CO 2 Masimo SET 70 100 0 02 5 Biotek Index 2 Masimo 3 Masimo SET 25 240bpm 70 100 0 02 5 Biotek Index 2 Masimo 4 Nellcor Technology Masimo SET RD SET www Masimo com 5 C 40 C 4...

Страница 90: ...cs Sensor Cable symbols 03 06 GR 14231 DRO 13914 40 C 70 C 1060 hPa 500 hPa 795 mmHg 375 mmHg 5 95 RH 5 95 LATEX PCX 2108A 02 13 X LED LED http www Masimo com TechDocs eIFU http www masimo com patents...

Страница 91: ...Y MM DD NON STERILE LATEX Title Graphics Sensor Cable symbols 03 06 GR 14231 DRO 13914 40 C 70 C 1060 hPa 500 hPa 795 mmHg 375 mmHg 5 95 RH 5 95 LATEX PCX 2108A 02 13 X LED LED http www Masimo com Tec...

Страница 92: ...3 Arms Arms Masimo SET 1 SpO2 100 70 0 02 Masimo Biotek Index 2 Masimo SET 2 100 70 5 Masimo Biotek Index 2 240 25 Masimo SET 3 100 70 5 0 02 Nellcor 4 RD SET Masimo SET www Masimo com 40 5 104 41 70...

Страница 93: ...SIQ 8760 X Cal 1 1 2 2 1 3 2 4 1 5 2 6 1 2 70 3 7 4 4 Cidex 2250 Metricide 28 Metrex Aspeti Wipe Huntington Brand ECOLAB 10 1 5 6 7 1 Cidex 2250 Metricide 28 Metrex Aspeti Wipe Huntington Brand ECOLA...

Страница 94: ...95 mmHg 375 mmHg 5 95 RH 5 95 Masimo rainbow SET Masimo SET SpO2 RD SET DBI SpO2 Philips FAST SpO2 Nellcor Nellcor SpO2 RD SET DBI SpO2 4 RD SET DBI Masimo SET RD SET DBI Masimo rainbow SET RD SET DBI...

Страница 95: ...ing the DBI sensors with Masimo SET Oximetry Technology in a clinical study MEASURED ARMS VALUES RANGE Arms 90 100 1 01 80 90 1 54 70 80 2 06 OVERALL CLAIMED ACCURACY VALUE 70 100 1 60 SaO2 versus err...

Страница 96: ...0119 2019 Masimo 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 Hanno...

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