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Tragbarer Kapnograph/PulsoximeterOXIMAX® N-85™
Genauigkeitstabelle für die Sauerstoffsättigung
OXIM AX®-Sensormodelle zur einmaligen Verwendung
Genauigkeit
Die Angaben zur Genauigkeit beruhen auf kontrollierten
Hypoxiestudien mit gesunden, nichtrauchenden, erwachsenen
Freiwilligen über den (oder die) angegebenen SpO2-Bereich(e).1
Die mit dem Pulsoximeter gemessenen SpO2-Werte werden mit
SaO2-Werten von mittels Hämoximetrie gemessenen Blutproben
verglichen. Alle Genauigkeiten werden in Form von ± x Stellen
ausgedrückt. Die Pulsoximetermessungen sind statistisch verteilt.
Es kann davon ausgegangen werden, dass etwa zwei Drittel der
Pulsoximetermessungen in diesen Genauigkeitsbereich (Aeff) fallen.
Bei sich teilweise überschneidenden Bereichen können verschiedene
Genauigkeitswerte angegeben sein, da Streuung und Abweichung
bei einem Vergleich von Pulsoximeter-SpO2 und BlutprobenSaO2 mit abnehmender Sättigung in der Regel zunehmen und
die Genauigkeit anhand von Daten aus dem gesamten genannten
Bereich berechnet wird.
SpO2-Bereich
LoSat
60 %–80 % 70 %–100 %
TM
MAX-A, MAX-AL
±3
±2
MAX-N
±3
±2
MAX-P
±3
±2
MAX-I
±3
±2
MAX-FAST
±3
±2
SC-A
±2
SC-PR
±2
SC-NEO
±2
± 3,5
MAX-R
Die Genauigkeit der Sauerstoffsättigung kann durch bestimmte
8PJHEXQJV*HUlWHXQGSK\VLRORJLVFKH*HJHEHQKHLWHQEHHLQÀXVVW
werden (siehe Bedienungsanleitung für das Überwachungsgerät),
die sich auf die SpO2- und/oder SaO2-Messungen auswirken. Daher kann die klinische Genauigkeit von den unter
kontrollierten Laborbedingungen gemessenen Werten abweichen.
2
Kompatibilität
Verwenden Sie Nellcor-Sensoren ausschließlich mit Nellcor-Patientenüberwachungsgeräten, Überwachungsgeräten mit
Nellcor-Oximetrieinstrumenten oder Instrumenten, die für die Verwendung mit Nellcor-Sensoren zugelassen sind (mit
Nellcor kompatible Instrumente). Die Genauigkeitswerte und Kompatibiliätsdaten für bestimmte Instrumente und NellcorSensoren erhalten Sie beim jeweiligen Hersteller.
Spitzenwellenlänge und maximale Ausgangsleistung
Die Pulsoximetriesensoren von Nellcor enthalten Leuchtanzeigen (LED), die Rotlicht mit einer Wellenlänge von etwa
660 nm und Infrarotlicht mit einer Wellenlänge von etwa 900 nm abgeben. Die optische Gesamtausgangsleistung der
Sensor-LED liegt unter 15 mW.
1. Die Personen, an denen die SpO2 -Messgenauigkeit untersucht wurde, waren gesund und entstammten der heimischen Bevölkerung.
Einbezogen wurden Männer und Frauen im Alter von 18 bis 50 Jahren mit unterschiedlicher Hautpigmentierung.
MAX-N
Die klinische Funktionsfähigkeit wurde an Neugeborenen im Krankenhaus nachgewiesen. Die beobachtete SpO2-Genauigkeit betrug 2,5 %,
wobei in die Studie 42 Patienten im Alter zwischen 1 und 23 Tagen und mit einem Gewicht zwischen 750 und 4100 g einbezogen wurden
und 63 Beobachtungen über einen Bereich von 85 bis 99 % SaO2 vorgenommen wurden. Die Beobachtungen an Neugeborenen erfolgten
mit dem Überwachungsgerät Oximax N-595.
Softcare® SC-PR, SC-NEO
Die klinische Funktionsfähigkeit wurde an Neugeborenen und Kleinkindern im Krankenhaus nachgewiesen. Die beobachtete SpO2-Genau-igkeit betrug 3,0 %, wobei in die Studie 57 Patienten im Alter zwischen 24 und 40 Wochen und mit einem Gewicht zwischen 710 und 5000
g einbezogen wurden und 185 Beobachtungen über einen Bereich von 63 bis 100 % SaO2.
2. Die Genauigkeit wurde bei Sättigungen zwischen 80 und 100 % ermittelt.
(LQHhEHUVLFKWEHUGLH6HQVRUJHQDXLJNHLW¿QGHQ6LHXQWHUwww.nellcor.com
© 2006 Nellcor Puritan Bennett Inc. Alle Rechte vorbehalten.
6
Tragbarer Kapnograph/PulsoximeterOXIMAX® N-85™
Genauigkeitstabelle für die Sauerstoffsättigung
OXIM AX®-Sensormodelle
Genauigkeit
Die Angaben zur Genauigkeit beruhen auf kontrollierten
Hypoxiestudien mit gesunden, nichtrauchenden,
erwachsenen Freiwilligen über den (oder die) angegebenen
SpO2-Bereich(e).1 Die mit dem Pulsoximeter gemessenen
SpO 2 -Werte werden mit SaO 2 -Werten von mittels
Hämoximetrie gemessenen Blutproben verglichen. Alle
Genauigkeiten werden in Form von ± x Stellen ausgedrückt.
Die Pulsoximetermessungen sind statistisch verteilt. Es
kann davon ausgegangen werden, dass etwa zwei Drittel
der Pulsoximetermessungen in diesen Genauigkeitsbereich
(Aeff) fallen.
Genauigkeit bei Neugeborenen
Werden die Sensoren bei Neugeboreren vorschriftsmäßig
verwendet, so liegt die angegebene Genauigkeit um ±
1 Stelle höher als bei Erwachsenen, wodurch der
theoretischen Auswirkung des Fetalhämoglobis im
Blut von Neugeborenen Rechnung getragen wird.
Die Genauigkeit von OxCliq N etwa beträgt bei
Neugeborenen nicht ± 2,5, sondern ± 3,5.
Die Genauigkeit der Sauerstoffsättigung kann durch
bestimmte Umgebungs-, Geräte- und physiologische
* H J H E H Q K H L W H Q E H H L Q À X V V W Z H U G H Q V L H K H
Bedienungsanleitung für das Überwachungsgerät), die sich
auf die SpO2- und/oder SaO2-Messungen auswirken. Daher
kann die klinische Genauigkeit von den unter kontrollierten
Laborbedingungen gemessenen Werten abweichen.
SpO2-Bereich
OXIM AX OxiCliq® zur einmaligen Verwendung
70 %–100 %
OxiCliq A
± 2,5
OxiCliq P
± 2,5
OxiCliq N (Erwachsene)
± 2,5
OxiCliq N (Neugeborene)
± 3,5
OxiCliq I
± 2,5
WIEDERVERWENDBARE OXIM AX-Sensoren
70 %–100 %
D-YS (Kinder und Erwachsene)
±3
D-YS (Neugeborene)
±4
D-YS mit Ohrclip D-YSE
± 3,5
D-YS mit Stichprobenclip D-YSPD
± 3,5
DS-100A
±3
OXI-A/N (Erwachsene)
±3
OXI-A/N (Neugeborene)
±4
OXI-P/I
±3
Kompatibilität
Verwenden Sie Nellcor-Sensoren ausschließlich mit Nellcor-Patientenüberwachungsgeräten, Überwachungsgeräten
mit Nellcor-Oximetrieinstrumenten oder Instrumenten, die für die Verwendung mit Nellcor-Sensoren zugelassen sind
(mit Nellcor kompatible Instrumente). Die Genauigkeitswerte und Kompatibiliätsdaten für bestimmte Instrumente und
Nellcor-Sensoren erhalten Sie beim jeweiligen Hersteller.
Spitzenwellenlänge und maximale Ausgangsleistung
Die Pulsoximetriesensoren von Nellcor enthalten Leuchtanzeigen (LED), die Rotlicht mit einer Wellenlänge von etwa
660 nm und Infrarotlicht mit einer Wellenlänge von etwa 900 nm abgeben. Die optische Gesamtausgangsleistung der
Sensor-LED liegt unter 15 mW.
1. Die Personen, an denen die SpO2 -Messgenauigkeit untersucht wurde, waren gesund und entstammten der heimischen Bevölkerung.
Einbezogen wurden Männer und Frauen im Alter von 18 bis 50 Jahren mit unterschiedlicher Hautpigmentierung.
(LQHhEHUVLFKWEHUGLH6HQVRUJHQDXLJNHLW¿QGHQ6LHXQWHUwww.nellcor.com
© 2006 Nellcor Puritan Bennett Inc. Alle Rechte vorbehalten.
Tyco Healthcare Group LP
Nellcor Puritan Bennett Division
Pleasanton, CA USA
1-800-NELLCOR
Bevollmächtigter Vertreter
Tyco Healthcare UK LTD
Gosport PO13 0AS, U.K.
7
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19
OXIMAX® N-85™ NDQQHWWDYDKRLWRSDLNDVVDNl\WHWWlYlNDSQRJUD¿SXOVVLRNVLPHWUL
Happisaturaation tarkkuuskaavio
OXIM AX® -anturimallit Yhden potilaan käyttöön
Tarkkuustiedot
Tarkkuustiedot perustuvat kontrolloituihin hypoksiatutkimuksiin,
joihin ovat osallistuneet terveet, tupakoimattomat aikuiset
vapaaehtoiset, määritetyssä SpO2-saturaatioissa.1 Pulssioksimetrin
SpO2-lukemia verrattiin otettujen verinäytteiden SaO2-arvoihin,
jotka mitattiin hemoksimetrialla. Kaikki tarkkuudet on ilmoitettu
± “X” numeroina. Pulssioksimetrialaitteilal saadut mittaustulokset
jakautuvat tilastollisesti. Noin 2/3 pulssioksimetrian tuloksista
voidaan olettaa olevan tällä tarkkuuden (ARMS) vaihteluvälillä.
Koska pulssioksimetrian SpO 2 :n ja veren SaO 2 -vertailujen
hajonta ja painotus kasvavat yleisesti saturaation laskiessa ja koska
tarkkuustiedot lasketaan ilmoitetulla välillä olevista tiedoista,
tuloksena voi olla eri tarkkuusarvoja, kun kuvataan osittain
päällekkäisiä alueita.
Happisaturaation tarkkuuteen voivat vaikuttaa tietyt ympäristöön,
laitteistoon ja potilaan fysiologiaan liittyvät tilat (katso monitorin
käyttöohje), jotka vaikuttavat SpO 2- tai SaO 2-tuloksiin tai
kumpaankin. Tästä syystä kliinisen tarkkuuden tarkastelu ei
välttämättä ole samalla tasolla kuin kontrolloiduissa laboratorioolosuhteissa.
SpO2-vaihteluväli
LoSat
60%–80%
TM
70%–100%
MAX-A, MAX-AL
±3
±2
MAX-N
±3
±2
MAX-P
±3
±2
MAX-I
±3
±2
MAX-FAST
±3
±2
SC-A
±2
SC-PR
±2
SC-NEO
±2
MAX-R
± 3.5
2
Yhteensopivuutta koskevat tiedot
Käytä Nellcor-antureita vain Nellcor-potilasmonitoreissa ja monitoreissa, jotka sisältävät Nellcor-oksimetrian, tai
instrumenteilla, jotka on lisensoitu käytettäviksi Nellcor-antureilla (Nellcor-yhteensopivat instrumentit). Pyydä valmistajilta
tarkkuustiedot ja yhteensopivuustiedot tiettyjen instrumenttien ja Nellcor-anturimallien suhteen.
Huippuaallonpituuden vaihteluväli ja suurin lähtöteho
Nellcor-pulssioksimetrianturit sisältävät LED-valoja, jotka lähettävät punaista valoa noin 660 nm:n aallonpituudella ja
infrapunavaloa noin 900 nm:n aallonpituudella. Anturin LED-valojen optinen kokonaisteho on alle 15 mw.
1. Potilaat, joilla SpO2 -mittauksen tarkkuudet arvioitiin, olivat terveitä ja heidät rekrytoitiin paikallisesta populaatiosta. Potilaiden
joukossa oli sekä miehiä että naisia. Potilaiden ihopigmentti vaihteli. Potilaat olivat iältään 18-50-vuotiaita.
MAX-N
Kliininen toiminta on osoitettu sairaalahoidossa olevilla vastasyntyneillä potilailla. Havaittu SpO2-tarkkuus oli 2,5 % tutkimuksessa, jossa
oli 42 potilasta (ikä 1 - 23 vrk ja paino 750 - 4 100 grammaa) 63 havainnointikertaa antoivat vaihteluväliksi 85 - 99 % SaO2. Vastasyntyneitä
tarkkailtiin Oximax N-595 -monitorilla.
Softcare® SC-PR, SC-NEO Kliininen toiminta on osoitettu sairaalahoidossa olevilla vastasyntyneillä potilailla ja vauvapotilailla.
Havaittu SpO2 -tarkkuus oli 3,0 % 57 potilaan (ikä 24 - 40 viikkoa ja paino 710 - 5 000 grammaa) 185 havainnointikertaa antoivat
vaihteluväliksi 63 - 100 % SaO2.
2. Tarkkuustiedot on määritetty saturaatiovälillä 80 – 100 %.
Antureiden tarkkuuskaavioihin voi tutustua verkossa osoitteessa www.nellcor.com
© Copyright 2006 Nellcor Puritan Bennett Inc. Kaikki oikeudet pidätetään.
20
OXIMAX® N-85™ NDQQHWWDYDKRLWRSDLNDVVDNl\WHWWlYlNDSQRJUD¿SXOVVLRNVLPHWUL
Happisaturaation tarkkuuskaavio
OXIM AX® -anturimallit
Tarkkuustiedot
Ta r k k u u s t i e d o t p e r u s t u v a t k o n t r o l l o i t u i h i n
hypoksiatutkimuksiin, joihin ovat osallistuneet terveet,
tupakoimattomat aikuiset vapaaehtoiset, määritetyssä
SpO 2-saturaatioissa. 1 Pulssioksimetrin SpO 2-lukemia
verrattiin otettujen verinäytteiden SaO2-arvoihin, jotka
mitattiin hemoksimetrialla. Kaikki tarkkuudet on
ilmoitettu ± “X” numeroina. Pulssioksimetrialaitteilal
saadut mittaustulokset jakautuvat tilastollisesti. Noin 2/3
pulssioksimetrian tuloksista voidaan olettaa olevan tällä
tarkkuuden (ARMS) vaihteluvälillä.
Tarkkuus vastasyntyneillä
Kun antureita käytetään vastasyntyneillä suosituksen
mukaisesti, mainittu tarkkuusalue kasvaa ± 1 numerolla
verrattuna käyttöön aikuisilla. Näin voidaan ottaa
huomioon teoreettinen vaikutus vastasyntyneiden
veren sikiöhemoglobiinin oksimetriamittaustuloksiin.
Esimerkiksi OxiCliq N:n tarkkuus vastasyntyneillä on
± 3.5 numeroa eikä ± 2.5.
Happisaturaation tarkkuuteen voivat vaikuttaa tietyt
ympäristöön, laitteistoon ja potilaan fysiologiaan liittyvät
tilat (katso monitorin käyttöohje), jotka vaikuttavat SpO2tai SaO2-tuloksiin tai kumpaankin. Tästä syystä kliinisen
tarkkuuden tarkastelu ei välttämättä ole samalla tasolla kuin
kontrolloiduissa laboratorio-olosuhteissa.
SpO2OXIM AX OxiCliq® Yhden potilaan käyttöön
70%–100%
OxiCliq A
± 2.5
OxiCliq P
± 2.5
OxiCliq N (aikuiset)
± 2.5
OxiCliq N (vastasyntyneet)
± 3.5
OxiCliq I
± 2.5
OXIM AX kestokäyttöiset anturit
70%–100%
D-YS (lapsista aikuisiin)
±3
D-YS (vastasyntyneet)
±4
D-YS D-YSE-korvaklipsillä
± 3.5
D-YS D-YSPD-pistetarkistuksella
± 3.5
DS-100A
±3
OXI-A/N (Aikuiset)
±3
OXI-A/N (Vastasyntyneet)
±4
OXI-P/I
±3
Yhteensopivuutta koskevat tiedot
Käytä Nellcor-antureita vain Nellcor-potilasmonitoreissa ja monitoreissa, jotka sisältävät Nellcor-oksimetrian, tai
instrumenteilla, jotka on lisensoitu käytettäviksi Nellcor-antureilla (Nellcor-yhteensopivat instrumentit). Pyydä valmistajilta
tarkkuustiedot ja yhteensopivuustiedot tiettyjen instrumenttien ja Nellcor-anturimallien suhteen.
Huippuaallonpituuden vaihteluväli ja suurin lähtöteho
Nellcor-pulssioksimetrianturit sisältävät LED-valoja, jotka lähettävät punaista valoa noin 660 nm:n aallonpituudella ja
infrapunavaloa noin 900 nm:n aallonpituudella. Anturin LED-valojen optinen kokonaisteho on alle 15 mw.
1. Potilaat, joilla SpO2 -mittauksen tarkkuudet arvioitiin, olivat terveitä ja heidät rekrytoitiin paikallisesta populaatiosta. Potilaiden
joukossa oli sekä miehiä että naisia. Potilaiden ihopigmentti vaihteli. Potilaat olivat iältään 18-50-vuotiaita.
Antureiden tarkkuuskaavioihin voi tutustua verkossa osoitteessa www.nellcor.com
© Copyright 2006 Nellcor Puritan Bennett Inc. Kaikki oikeudet pidätetään.
Tyco Healthcare Group LP
Nellcor Puritan Bennett Division
Pleasanton, CA USA
1-800-NELLCOR
Valtuutettu edustaja
Tyco Healthcare UK LTD
Gosport PO13 0AS, U.K.
21
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Tyco Healthcare Group LP
Nellcor Puritan Bennett Division
Pleasanton, CA USA
1-800-NELLCOR
Authorized Representative
Tyco Healthcare UK LTD
Gosport PO13 0AS, U.K.
www.nellcor.com
10013102A-0606
Ref: 010588