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O S M O L A R I T Y

T E S T C A R D S

Instructions for Use

Содержание OSMOLARITY

Страница 1: ...OSMOLARIT Y T E S T C A R D S Instructions for Use 930088 REV M 2019 TearLab Corporation...

Страница 3: ...TABLE OF CONTENTS ENGLISH 4 7 ESKY 11 DANSK 15 NEDERLANDS 18 SUOMI 22 FRAN AIS 26 DEUTSCH 30 34 ITALIANO 38 42 46 NORSK 50 PORTUGU S 53 57 61 SLOVEN INA 64 ESPA OL 68 SVENSKA 72 T RK E 75 84 PORTUGU...

Страница 4: ...sories Normal and High Osmolarity Control Solutions PRECAUTIONS 1 For in vitro diagnostic use only 2 Leave theTest Card in its sealed pouch until just before use 3 Do not remove the protective cover u...

Страница 5: ...RE Refer to the TearLab Osmolarity System User Manual for more information 1 Turn the Reader on 2 Remove aTest Card from its package 3 Attach aTest Card by sliding the wings of theTest Card onto theTe...

Страница 6: ...ould be tested and assessed to determine which eye represents the higher osmolarity 7 HUMAN FACTOR AND SAFETY Human factor usability and tear sampling discomfort and safety were evaluated at three phy...

Страница 7: ...L TearLab 3 TearLab a 50 nL b TearLab TearLab 1 2 3 4 5 6 7 15 30 C 59 86 F 8 American Academy of Ophthalmology AAO Occupational Safety and Health Administration OSHA 9 TearLab AAO 4 TearLab CDC Divis...

Страница 8: ...irmer TearLab TEARLAB 316 32 34 66 48 NPV 316 13 61 74 82 PPV 45 95 140 71 64 1 2 1 mOsm L 309 9 324 3 2 400 mOsm L 309 9 11 0 324 3 20 1 0 05 0 04 0 03 0 02 0 01 mOsm L 360 11 OU N 360 1 295 3 7 5 29...

Страница 9: ...1 858 455 6006 TearLab TearLab TearLab TearLab LCD mOsm L mOsm L cOsms L mOsm kg cOsms kg 1 6 TearLab 275 mOsm L 400 mOsm L 275 mOsm L 400 mOsm L TearLab TearLab TearLab TearLab TearLab TearLab 1 858...

Страница 10: ...16 4 5 1 41 6 6 2 08 345 4 5 1 30 8 0 2 33 TearLab Wescor 5520 NIST N R2 1 80 y 0 9146x 23 061 0 9443 y 0 9146x 23 061 r 2 0 9443 TearLab Wescor TearLab 40 Wescor 5520 Vapro Wescor N R2 3 120 y 0 9402...

Страница 11: ...kter nen sou st balen Detek n syst m osmolarity TearLab kter se skl d ze te ky per a elektronick ch kontroln ch karet P slu enstv Kontroln roztoky s norm ln a vysokou osmolaritou UPOZORN N 1 Pouze pr...

Страница 12: ...t po pou it anestetick ch nebo mydria tick ch dilata n ch o n ch kapek a po jin m invazivn m diagnostick m vy et en o Neodeb rejte vzorky slz od pacient d ve ne za 15 minut po vy et en t rbinovou lamp...

Страница 13: ...m stn z kaznickou podporu spole nostiTearLab nebo volejte americkou pobo ku spole nostiTearLab na sle 1 858 455 6006 O EK VAN V SLEDKY Referen n hodnoty osmolarity slz pro norm ln osoby a pacienty se...

Страница 14: ...dilata n ch o n ch kapek Slzy neodeb rejte od pacient kte v p edchoz ch 15 minut ch plakali FDA MEDWATCH P i podez en na jak koli z va n ne douc inky probl my s kvalitou chyby p i pou it produktu i t...

Страница 15: ...middelbart f r den skal bruges 3 Fjern ikke beskyttelseskappen f r testkortet er fastgjort p en pen og umiddelbart f r t reopsamlingen 4 Undg at ber re spidsen af testkortet 5 Testkortet m ikke bruges...

Страница 16: ...den for 15 minutter efter unders gelse med spaltelampe Foretag ikke opsamling af t rev ske fra en patient som har gr dt inden for de sidste 15 minutter FREMGANGSM DE VED TESTNING AF PATIENTER Yderlige...

Страница 17: ...ariere fra venstre til h jre je og hvert je skal testes og vurderesforatbestemme hvilket jederhardenh jesteosmolaritet 7 MENNESKELIG FAKTOR OG SIKKERHED Anvendeligheden af den menneskelige faktor og u...

Страница 18: ...afdekking De testkaarten zijn ontworpen voor gebruik samen met hetTearLab osmolariteitsysteem REAGENTIA De testkaarten bevatten geen reagentia of chemicali n Geleverde materialen osmolariteittestkaart...

Страница 19: ...nvochtmonsters direct uit het oog Raadpleeg de gebruikshandleiding van het TearLab osmolariteitsysteem voor de juiste traanvochtverzameltechniek Het verzamelen van traanvocht moet aan de laterale temp...

Страница 20: ...etbereikislineairvan275tot400mOsms L Testresultaten buiten dit meetbereik worden gerapporteerd als ofwel Onder bereik wat een meting onder 275 mOsms L aangeeft ofwel Boven bereik wat een meting boven...

Страница 21: ...t uit het oog te worden afgenomen Neem geen tranen af binnen twee uur na gebruik van medicinale of kleurende oogdruppels of binnen 15 minuten na het gebruik van verdovende of mydriatische dilaterende...

Страница 22: ...Osmolariteetin testikortit Toimitukseen eiv t kuulu seuraavat materiaalit TearLab osmolariteettij rjestelm joka sis lt lukijan kyn t ja elektroniset tarkistuskortit Lis tarvikkeet Normaalin ja korkean...

Страница 23: ...tulee ker t lateraalisesta ohimonpuoleisesta silm luomen nurkasta jossa tahattoman sarveiskalvovaurion aiheutumisriski voidaan minimoida toisin kuin sarveiskalvon l heisyydess jossa vaurion todenn k...

Страница 24: ...ej Mittausalueen ulkopuolella olevat arvot ovat hyvin harvinaisia ja ne tulisikin varmentaa uudella testill koska mittausalueen ulkopuoliset arvot saattavat indikoida virhett esim k ytt j virhe testin...

Страница 25: ...eik 15 minuuttiinnukutusaineentaipupillialaajentaviensilm tippojenk yt st Kyynelnestett ei saa ker t 15 minuuttiin potilaalta joka on itkenyt FDA MEDWATCH Raportoi vakava haittavaikutus tuotteen laatu...

Страница 26: ...t con ue pour tre utilis e avec le syst me d osmolarit TearLab R ACTIFS Les cartes de test ne contiennent aucun r actif ni produit chimique Mat riel fourni Cartes de test d osmolarit Mat riel non four...

Страница 27: ...porter au manuel de l utilisateur du syst me d osmolarit TearLab concernant la technique de pr l vement de larme appropri e Le pr l vement de larme doit tre effectu selon une port e lat rale temporale...

Страница 28: ...la plage pour indiquer une mesure sup rieure 400 mOsms L LIMITES DU TEST Les r sultats de l osmom treTearLab doivent tre valu s avec toutes les donn es cliniques et de laboratoire disposition S ils n...

Страница 29: ...dicinales ou de coloration ni dans les 15 minutes suivant l application de gouttes oculaires anesht siques ou mydriatiques dilatantes Ne pas pr lever de larmes dans les 15 minutes sur des patients aya...

Страница 30: ...ie Testkarten sind so konzipiert dass sie zusammen mit dem TearLab Osmolarit tssystem verwendet werden k nnen REAGENZIEN DieTestkarten enthalten keine Reagenzien oder Chemikalien Gelieferte Materialie...

Страница 31: ...9 95 1 00 Pegel 4 377 2 7 2 377 0 7 1 Schnittpunkt 95 CI 1 3 14 3 KONTRAINDIKATIONEN Es k nnen menschliche Tr nenfl ssigkeitsproben verwendet werden EntnehmenSiedieTr nenfl ssigkeitsprobendirektausde...

Страница 32: ...schied zwischen Osmolarit t und Osmolalit t weniger als 1 In der klinischen Literatur werden die Begriffe h ufig gleichbedeutend verwendet da der Unterschied unbedeutend ist 6 DerTearLab Messbereich i...

Страница 33: ...molarit t y 0 9402x 12 512 r 2 0 9515 ST RENDE SUBSTANZEN Tr nenproben m ssen direkt aus dem Auge entnommen werden Entnehmen Sie keine Tr nen wenn innerhalb der letzten zwei Stunden medizinische oder...

Страница 34: ...nL TearLab 3 TearLab 50 nL TearLab TearLab 1 in vitro 2 3 4 5 6 7 15 30 C 59 86 F 8 American Academy of Ophthalmology AAO OSHA Occupational Safety and Health Administration 9 TearLab AAO 4 TearLab CD...

Страница 35: ...r TearLab TEARLAB 316 32 34 66 48 NPV 316 13 61 74 82 PPV 45 95 140 71 64 1 2 1 mOsms L 309 9 324 3 2 400 mOsms L 309 9 11 0 324 3 20 1 0 05 0 04 0 03 0 02 0 01 mOsms L 360 11 OU N 360 1 295 3 7 5 295...

Страница 36: ...TearLab TearLab TearLab TearLab LCD mOsms L milliosmoles mOsms L centiosmoles cOsms L milliosmoles mOsms kg centiosmoles cOsms kg 1 6 TearLab 275 mOsm L 400 mOsm L 275 mOsm L 400 mOsm L TearLab TearLa...

Страница 37: ...316 4 5 1 41 6 6 2 08 345 4 5 1 30 8 0 2 33 TearLab Wescor 5520 NIST N R2 1 80 y 0 9146x 23 061 0 9443 y 0 9146x 23 061 r 2 0 9443 TearLab Wescor 40 TearLab Wescor 5520 Vapro Wescor N R2 3 120 y 0 940...

Страница 38: ...il test non contengono reagenti n componenti chimici Materiali forniti schede per il test dell osmolarit Materiali non forniti sistema di osmolarit diTearLab composto da Lettore penne e schede elettro...

Страница 39: ...ione di liquido lacrimale direttamente dall occhio Per conoscere la tecnica appropriata di prelievo lacrimale fare riferimento al Manuale d uso del Sistemadiosmolarit diTearLab Ilprelievolacrimaledeve...

Страница 40: ...che la differenza insignificante 6 L intervallo di misura di TearLab lineare da 275 mOsm L a 400 mOsm L I risultati del test al di fuori di questo intervallo di misurazione verranno riportati come In...

Страница 41: ...9402x 12 512 r 2 0 9515 SOSTANZE INTERFERENTI I campioni di liquido lacrimale devono essere prelevati direttamente dall occhio Nonprelevareliquidolacrimaleprimadelledueoresuccessive all uso di gocce...

Страница 42: ...b 1 2 3 4 5 6 7 15 30 59 F 86 F 8 AAO American Academy of Ophthalmology BBP OSHA Occupational Safety and Health Administration 9 TearLab AAO 4 TearLab CDC Disinfection and Sterilization of Patient Car...

Страница 43: ...Osms L 360 4 11 3 N 360 1 295 3 7 5 295 2 6 6 y 0 98 x 6 51 2 323 3 8 4 322 9 7 9 r2 0 9503 3 339 6 7 4 339 1 6 7 95 CI 0 95 1 00 4 377 2 7 2 377 0 7 1 95 CI 1 3 14 3 TearLab Osmolarity System User Ma...

Страница 44: ...ab 858 455 6006 309 9 mOsms L 11 0 288 331 mOsms L 90 CI 288 331 324 3 mOsms L 20 1 291 382 mOsms L 90 CI 284 392 7 TearLab 5 0 4 8 234 1 4 1 14 NIST National Institute of Standards and Technology Tea...

Страница 45: ...930088 Rev M 45 TearLab Wescor 5520 2 15 15 FDA MEDWATCH TearLab TearLab 858 455 6006 FDA MedWatch 800 FDA 1088 Fax 800 FDA 0178 www fda gov medwatch...

Страница 46: ...5 30 C 59 86 F 8 American Academy of Ophthalmology AAO OSHA Occupational Safety and Health Administration s 9 TearLab AAO 4 TearLab 1 CDC Division of Healthcare Quality Promotion Disinfection and Ster...

Страница 47: ...Osms L 309 9 11 0 324 3 20 1 0 05 0 04 0 03 0 02 0 01 mOsms L 360 11 OU N 360 1 295 3 7 5 295 2 6 6 y 0 98 x 6 51 2 323 3 8 4 322 9 7 9 r2 0 9503 3 339 6 7 4 339 1 6 7 95 CI 0 95 1 00 4 377 2 7 2 377...

Страница 48: ...Osms L 11 0 288 331 mOsms L 90 CI 288 331 Mean 324 3 mOsms L 20 1 291 382 mOsms L 90 CI 284 392 7 TearLab 4 8 5 0 234 1 4 1 14 National Institute of Standards and Technology NIST TearLab MOSMS L SD CV...

Страница 49: ...930088 Rev M 49 2 15 15 FDA MEDWATCH TearLab TearLab 1 858 455 6006 FDA MedWatch 800 FDA 1088 800 FDA 0178 www fda gov medwatch...

Страница 50: ...ofesjonell in vitro diagnostisk bruk 2 La testkortet v re i den forseglede posen helt til like f r det skal brukes 3 Ikke fjern beskyttelsesdekselet f r teskortet er festet til en penn og umiddelbart...

Страница 51: ...masjon 1 Sl p avleseren 2 Ta ut et testkort fra pakken 3 Fest et testkort ved skyve flikene p testkortet inn p TearLab pennen Pennen lyser og piper n r kortet er riktig festet Det gr nne lysetvilforts...

Страница 52: ...or p mennesker ubehag ved t reoppsamling og sikkerhet ble vurdert ved tre forskjellige legesentre Resultatene viste at TearLab osmolaritetssystem har en positiv brukbarhetsfaktor p 4 8 av 5 0 Blant 23...

Страница 53: ...e cl nica e cont m um revestimento de protec o Os Cart es de Teste destinam se a funcionar em conjunto com o Sistema de Osmolaridade daTearLab REAGENTES Os Cart es deTeste n o cont m nenhum reagente o...

Страница 54: ...representando uma popula o demogr fica educacional et ria de g nero etc diversa RESULTADOS DO ESTUDO COM UTILIZADOR N O TREINADO M dia do Utilizador Treinado M dia OU An lise regressiva N 360 amostras...

Страница 55: ...N o s o necess rios quaisquer c lculos As determina es de concentra o de osm tica s o n o raro expressas em osmolaridade milimoles litro ou seja mOsms L ou centimoles litro ou seja cOsms L ou osmolar...

Страница 56: ...12 512 0 9515 Osmolaridade da TearLab Osmolaridade daWescor y 0 9402x 12 512 r 2 0 9515 SUBST NCIAS INTERFERENTES As amostras lacrimais devem ser colhidas directamente do olho N o proceda colheita de...

Страница 57: ...ab CLIA CLIA CLIA TearLab 1 2 TearLab TearLab nL TearLab 3 TearLab a 50 nL b TearLab TearLab 1 in vitro 2 3 4 5 6 7 15 30 C 59 86 F 8 American Academy of Ophthalmology AAO OSHA Occupational Safety and...

Страница 58: ...95 OSDI 2 TBUT TearLab TEARLAB 316 32 34 66 48 NPV 316 13 61 74 82 PPV 45 95 140 71 64 1 2 P 1 mOsms L 309 9 324 3 2 400 mOsms L 309 9 11 0 324 3 20 1 0 05 0 04 0 03 0 02 0 01 mOsms L CLIA 360 11 UO N...

Страница 59: ...1 2 3 TearLab 4 5 TearLab 6 40 7 RECALL 8 9 TearLab 1 2 TearLab TearLab TearLab 858 455 6006 TearLab TearLab TearLab TearLab TearLab mOsms L mOsms L mOsms kg cOsms kg 1 6 TearLab 275 mOsms L 400 mOsms...

Страница 60: ...MOSMS L SD CV SD CV 280 3 8 1 34 5 2 1 87 294 5 5 1 85 7 3 2 47 316 4 5 1 41 6 6 2 08 345 4 5 1 30 8 0 2 33 TearLab Wescor Model 5520 NIST N R2 1 80 y 0 9146 x 23 061 0 9443 y 0 9146x 23 061 r 2 0 94...

Страница 61: ...AO OSHA 9 TearLab AAO 4 TearLab CDC Division of Healthcare Quality Promotion Disinfection and Sterilization of Patient Care Equipment 1985 2005 6 22 20 C 25 C 15 C 30 C 5 316 mOsms L 69 92 82 TearLab...

Страница 62: ...9 r2 0 9503 3 339 6 7 4 339 1 6 7 95 CI 0 95 1 00 4 377 2 7 2 377 0 7 1 95 CI 1 3 14 3 TearLab 2 15 15 15 TearLab 1 2 3 TearLab 2 4 5 TearLab 6 40 7 RECALL OK 8 8 9 TearLab 1 2 TearLab TearLab 858 455...

Страница 63: ...NIST TearLab MOSMS L 280 3 8 1 34 5 2 1 87 294 5 5 1 85 7 3 2 47 316 4 5 1 41 6 6 2 08 345 4 5 1 30 8 0 2 33 NIST TearLab Wescor 5520 R2 1 80 y 0 9146x 23 061 0 9443 TearLab Wescor 5520 40 7 TearLab...

Страница 64: ...nie osmolarityTearLab REAGENCIE Karty na testovanie neobsahuj iadne reagencie ani chemik lie Dod van materi ly Karty na testovanie osmolarity Materi ly ktor sa nedod vaj Syst m na testovanie osmolarit...

Страница 65: ...EN CH POU VATE OV Priemer za kolen ch pou vate ov Priemer OU Regresn anal za N 360 vzoriek rove 1 295 3 7 5 295 2 6 6 y 0 98 x 6 51 rove 2 323 3 8 4 322 9 7 9 r2 0 9503 rove 3 339 6 7 4 339 1 6 7 smer...

Страница 66: ...ram teda mOsm kg alebo ako centiosmoly kilogram teda cOsm kg V slznej tekutine je rozdiel medzi osmolaritou a osmolalitou men ne 1 V klinickej literat re je be n navz jom zamenite n pou vanie t chto p...

Страница 67: ...y 0 9402x 12 512 0 9515 y 0 9402x 12 512 r 2 0 9515 Osmolarita TearLab OsmolaritaWescor RU IV L TKY Vzorky s z sa maj odobera priamo z oka Neodoberajte slzy do dvoch hod n od pou itia medikament znych...

Страница 68: ...as tarjetas de prueba est n dise adas para que funcionen junto con el sistema de osmolaridad TearLab REACTIVOS Las tarjetas de prueba no contienen reactivos ni qu micos Materiales provistos tarjetas d...

Страница 69: ...ONES Se pueden usar muestras de l quidos lagrimales humanos Recoja las muestrasdel quidolagrimaldirectamentedelojo ConsulteelManualdel usuario del sistema de osmolaridad TearLab para conocer la t cnic...

Страница 70: ...mo es decir cOsms kg En el l quido lagrimal la diferencia entre osmolaridad y osmolalidad es menor que el 1 y por lo general en la bibliograf a cl nica se usan ambos t rminos como sin nimos dado que l...

Страница 71: ...d TearLab OsmolaridadWescor y 0 9402x 12 512 r 2 0 9515 SUSTANCIAS INTERFERENTES Las muestras de l grimas deben recogerse directamente del ojo No recoja las l grimas durante las dos horas posteriores...

Страница 72: ...TearLabs osmolaritetssystem best ende av L sare pennor och elektroniska kontrollkort Tillbeh r Kontroll sningar f r normal och h g osmolaritet F RSIKTIGHETS TG RDER 1 Endast f r in vitro diagnostik 2...

Страница 73: ...spaltlampa Samla inte upp t rv tska inom 15 minuter fr n en patient som har gr tit PROCEDUR F R PATIENTTESTNING MerinformationfinnsibruksanvisningentillTearLabosmolaritetssystem 1 S tt p l saren 2 Ta...

Страница 74: ...b da gonen ska testas och bed mas f r att best mma vilket ga som visar p den h gre osmolariteten 7 M NSKLIGA FAKTORN OCH S KERHET Anv ndbarhet och obehag vid t ruppsamlingen har studerats av tre klin...

Страница 75: ...meyen Materyaller unlardan olu an TearLab Osmolarite Sistemi Okuyucu Kalemler ve Elektronik Kontrol Kartlar Aksesuarlar Normal veY ksek Osmolarite Kontrol Sol syonlar NLEMLER 1 Sadece in vitro tan sal...

Страница 76: ...le tirici g z damlalar n n ve di er invazif ok ler tan sal testlerin kullan m ndan sonraki 15 dakika boyunca g zya s v s almay n G zya s v s n birbiyomikroskopmuayenesindensonraki15dakikai inde toplam...

Страница 77: ...efondan TearLab ile temasa ge in Hi bir sonu elde edilemezse veya cihazla ilgili sorun ya arsan z b lgenizdeki TearLab m teri deste i ile veya 1 858 455 6006 numaral telefondanTearLab ile temasa ge in...

Страница 78: ...15 dakika boyunca g zya s v s almay n A lam hastalardan 15 dakika boyunca g zya s v s almay n FDA MEDWATCH Ciddi advers olaylar r n kalitesi sorunlar n r n kullan m hatas n veya TearLab Osmolarite Sis...

Страница 79: ...930088 Rev M 79 y 0 9402x 12 512 r 2 0 9515...

Страница 80: ...80 930088 Rev M y 0 9146x 23 061 r 2 0 9443...

Страница 81: ...930088 Rev M 81...

Страница 82: ...82 930088 Rev M...

Страница 83: ...930088 Rev M 83...

Страница 84: ...84 930088 Rev M...

Страница 85: ...ENTES Os cart es de teste n o cont m nenhum reagente ou produto qu mico Materiais fornecidos Cart es deTeste de Osmolaridade Materiais n o fornecidos Sistema de osmolaridade TearLab consistindo em Lei...

Страница 86: ...eamostrasdefluido lacrimal diretamente do olho Consulte o manual do usu rio do sistema de osmolaridadeTearLabparaobterumat cnicaadequadadecoletadel grimas A coleta de l grimas deve ser realizada na ex...

Страница 87: ...ificante 6 O intervalo de medi o da TearLab linear de 275 mOsms L a 400 mOsms L Os resultados de testes fora desse intervalo de medi o ser o informados como Abaixo do intervalo indicando uma medi o ab...

Страница 88: ...da TearLab Wescor modelo 5520 y 0 9402x 12 512 r 2 0 9515 SUBST NCIAS INTERFERENTES Amostras de l grimas devem ser coletadas diretamente do olho N o colete l grimas no per odo de duas horas depois do...

Страница 89: ...sowania cznie z aparatemdobadaniaosmolarno ciTearLab ODCZYNNIKI Karty do badania nie zawieraj adnych odczynnik w ani rodk w chemicznych Materia y dostarczone Karty do badania osmolarno ci Materia y ni...

Страница 90: ...ZWOLNIENIA Przeprowadzono badanie z udzia em nieprzeszkolonych u ytkownik w w kt rymuczestnikomudzielonotylkowskaz wekwzakresiewykonywaniatestui poproszono ich o przebadanie cznie 360 zamaskowanych zr...

Страница 91: ...arLab nale y stosowa wy cznie p yny kontrolne do badania osmolarno ci TearLab P yny kontrolne do badania osmolarno ci nie wchodz w sk ad zestawu aparatu do badania osmolarno ciTearLab ani kart do bada...

Страница 92: ...tem do badania osmolarno ciTearLab Laboratoria gabinet w lekarskich nie mia y dost pu do osmometru Wescor 5520 Vapro wykorzystuj cego ci nienie pary Warto ci Wescor uzyskano na podstawie redniej z dw...

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Страница 96: ...aard K Smidt BC Electrolytic Conductivity Osmotic Pressure and Hydrogen Ion Concentration of Human Lachrymal Fluid ActaDermVenereolSuppl Stockh 1952 32 29 261 7 4 MinimizingTransmission of Bloodborne...

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