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Versiotiedot

Duodecim Laskurit ja lomakkeet (EBMEDS®) on EU MDR 2017/745 mukainen IIa-luokan lääkinnällinen laite. Duodecim Päätöksentuen käyttöohjeet.

UDI-tiedot: UDI 06429810586025(8012)EBMEDSv4.0.3

Versiotiedot: EBMEDS 4.0.3, EBMEDS Master Data 3.0.3

Valmistusajankohta: 2/2025

Tuotteen viimeinen käyttöpäivä: 2 vuotta valmistuspäivämäärästä

Laitteen valmistaja on Kustannus Oy Duodecim Osoite: Kaivokatu 8, 00101 Helsinki.


Käyttötarkoitus

Duodecim Laskurit ja lomakkeet (EBMEDS®) on lääkinnällinen laite, jolla käyttäjä voi laskea valikoituja kliinisessä työssä tarvittavia kaavoja. Osa laskureista soveltuu myös ei-ammattilaisten käyttöön (ISO-BMI, Finriski). Ei-ammattilaisille valikoidut laskurit soveltuvat yleiseen henkilökohtaisen hyvinvoinnin seurantaan ja niiden käyttötarkoitus ei ole lääkinnällinen. Laskurin yhteydestä löytyy lisätietoa sen käytöstä, soveltuvuudesta erilaisille potilaille ja mahdollisista muista huomioitavista rajauksista.

Varoitukset

Laite ei korvaa terveydenhuollon ammattilaista

Duodecim Laskurit ja lomakkeet on tarkoitettu tukemaan terveydenhuollon ammattilaisten päätöksentekoa. Se ei korvaa lääkärin tai muun terveydenhuollon ammattilaisen ammattitaitoa. Vastuu potilaan hoidosta on aina terveydenhuollon ammattilaisella.

Käyttäjän tulee noudattaa tulosten tulkinnassa varovaisuutta. Jokainen laskuri ja lomake on testattu

Ei tarkoitettu hätätilanteisiin

Duodecim Laskurit ja lomakkeet ei ole tarkoitettu käytettäväksi kriittisesti sairaiden potilaiden hoitoon tai hätätilanteissa.

Käyttäjän tulee huomioida mahdolliset virheet tai puutteet rakenteisissa lähtötiedoissa

Duodecim Laskurit ja lomakkeet on riippuvainen potilastietojärjestelmästä haettavista rakenteisista tiedoista. Puutteet tai virheet näissä tiedoissa voivat johtaa epätäydellisiin tai perusteettomiin muistutuksiin. Myös laskurille syötetyissä tai esitäytetyissä tiedoissa voi olla puutteita, jotka voivat johtaa virheelliseen vastaukseen. Käyttäjä vastaa itse syötettyjen tietojen oikeellisuuden tarkistamisesta.

Vastuunrajoitukset

Sisältökohtaiset rajoitukset

Käyttäjän on huomioitava mahdolliset laskuri- ja lomakekohtaiset rajaukset ja varmistettava sen soveltuvuus käytön kohteena olevalle potilaalle.

Versiondata

Duodecim Formulär och Kalkylatorer (EBMEDS®) är en medicinteknisk produkt i klass IIa enligt EU MDR 2017/745. Duodecim Clinical Decision Support bruksanvisning.

UDI-information: UDI 06429810586025(8012)EBMEDSv4.0.3

Versionsinformation: EBMEDS 4.0.3, EBMEDS Master Data 3.0.3

Tillverkningsdatum: 2/2025

Sista användningsdatum: 2 år från tillverkningsdatum

Tillverkare: Duodecim Publishing Company Ltd. Brunnsgatan Kaivokatu 8, 00101 Helsinki.


Avsett ändamål

Duodecim Formulär och Kalkylatorer (EBMEDS®) är en medicinteknisk produkt som gör det möjligt för användaren att beräkna utvalda formler som behövs i klinisk praxis. Vissa kalkylatorer är även lämpliga för icke-professionella användare (t.ex. ISO-BMI, Finriski). De kalkylatorer som är avsedda för icke-professionella lämpar sig för allmän övervakning av personligt välbefinnande, och deras avsedda ändamål är inte medicinskt. Ytterligare information om varje kalkylator, dess användning, lämplighet för olika patienter och eventuella övriga begränsningar finns i anslutning till kalkylatorn.

Varningar

Denna enhet ersätter inte en vårdprofessionell

Duodecim Formulär och Kalkylatorer är avsedd att stödja hälso- och sjukvårdspersonal i deras beslutsfattande. Den ersätter inte en läkares eller annan vårdprofessionells expertis. Ansvaret för patientens vård ligger alltid hos hälso- och sjukvårdspersonal.

Ej avsedd för akuta situationer

Duodecim Formulär och Kalkylatorer är inte avsedd att användas vid vård av kritiskt sjuka patienter eller i akuta situationer.

Användaren bör vara medveten om eventuella fel eller brister i de strukturerade indata

Duodecim Formulär och Kalkylatorer är beroende av strukturerade data från patientinformationssystemet. Brister eller fel i dessa data kan leda till ofullständiga eller omotiverade varningar. Felaktigheter i inmatade eller förifyllda data i kalkylatorn kan också leda till oriktiga resultat. Användaren är ansvarig för att kontrollera riktigheten i de inmatade uppgifterna.

Ansvarsfriskrivningar

Innehållsrelaterade begränsningar

Användaren måste beakta eventuella specifika begränsningar för enskilda kalkylatorer och formulär, och säkerställa att verktyget är lämpligt för den aktuella patienten.

Version information

Duodecim Forms and Calculators (EBMEDS®) is a class IIa medical device according to the EU MDR 2017/745. Duodecim Clinical Decision Support instructions for use.

UDI-information: UDI 06429810586025(8012)EBMEDSv4.0.3

Version information: EBMEDS 4.0.3, EBMEDS Master Data 3.0.3

Date of manufacture: 2/2025

Use by date: 2 years from the manufacture

The manufacturer is Duodecim Publishing Company Ltd. Address Kaivokatu 8, 00101 Helsinki.


Intended Use

Duodecim Forms and Calculators (EBMEDS®) is a medical device that enables the user to calculate selected formulas needed in clinical practice. Some calculators are also suitable for use by non-professionals (e.g., ISO-BMI, Finriski). The calculators intended for non-professional use are suitable for general personal wellbeing monitoring, and their intended purpose is not medical. Additional information about each calculator, its use, suitability for different patients, and any other limitations can be found alongside the calculator itself.

Warnings

This device does not replace a healthcare professional

Duodecim Forms and Calculators are intended to support healthcare professionals in their decision-making process. It does not replace the expertise of a physician or other healthcare professionals. Responsibility for patient care always remains with the healthcare professional.

Not intended for emergency situations

Duodecim Forms and Calculators are not intended for use in the treatment of critically ill patients or in emergency situations.

The user should be aware of possible errors or omissions in the structured input data

Duodecim Forms and Calculators are dependent on structured data retrieved from the patient information system. Any deficiencies or errors in this data may lead to incomplete or unjustified alerts. Similarly, errors in the data entered into or pre-filled in the calculator may lead to incorrect results. The user is responsible for verifying the accuracy of the entered data.

Disclaimers

Content-related limitations

Users must consider any form- and calculator-specific limitations and ensure that the tool is appropriate for the patient in question.

Version information

Duodecim Forms and Calculators (EBMEDS®) is a class IIa medical device according to the EU MDR 2017/745. Duodecim Clinical Decision Support instructions for use.

UDI-information: UDI 06429810586025(8012)EBMEDSv4.0.3

Version information: EBMEDS 4.0.3, EBMEDS Master Data 3.0.3

Date of manufacture: 2/2025

Use by date: 2 years from the manufacture

The manufacturer is Duodecim Publishing Company Ltd. Address Kaivokatu 8, 00101 Helsinki.


Intended Use

Duodecim Forms and Calculators (EBMEDS®) is a medical device that enables the user to calculate selected formulas needed in clinical practice. Some calculators are also suitable for use by non-professionals (e.g., ISO-BMI, Finriski). The calculators intended for non-professional use are suitable for general personal wellbeing monitoring, and their intended purpose is not medical. Additional information about each calculator, its use, suitability for different patients, and any other limitations can be found alongside the calculator itself.

Warnings

This device does not replace a healthcare professional

Duodecim Forms and Calculators are intended to support healthcare professionals in their decision-making process. It does not replace the expertise of a physician or other healthcare professionals. Responsibility for patient care always remains with the healthcare professional.

Not intended for emergency situations

Duodecim Forms and Calculators are not intended for use in the treatment of critically ill patients or in emergency situations.

The user should be aware of possible errors or omissions in the structured input data

Duodecim Forms and Calculators are dependent on structured data retrieved from the patient information system. Any deficiencies or errors in this data may lead to incomplete or unjustified alerts. Similarly, errors in the data entered into or pre-filled in the calculator may lead to incorrect results. The user is responsible for verifying the accuracy of the entered data.

Disclaimers

Content-related limitations

Users must consider any form- and calculator-specific limitations and ensure that the tool is appropriate for the patient in question.

Version information

Duodecim Forms and Calculators (EBMEDS®) is a class IIa medical device according to the EU MDR 2017/745. Duodecim Clinical Decision Support instructions for use.

UDI-information: UDI 06429810586025(8012)EBMEDSv4.0.3

Version information: EBMEDS 4.0.3, EBMEDS Master Data 3.0.3

Date of manufacture: 2/2025

Use by date: 2 years from the manufacture

The manufacturer is Duodecim Publishing Company Ltd. Address Kaivokatu 8, 00101 Helsinki.


Intended Use

Duodecim Forms and Calculators (EBMEDS®) is a medical device that enables the user to calculate selected formulas needed in clinical practice. Some calculators are also suitable for use by non-professionals (e.g., ISO-BMI, Finriski). The calculators intended for non-professional use are suitable for general personal wellbeing monitoring, and their intended purpose is not medical. Additional information about each calculator, its use, suitability for different patients, and any other limitations can be found alongside the calculator itself.

Warnings

This device does not replace a healthcare professional

Duodecim Forms and Calculators are intended to support healthcare professionals in their decision-making process. It does not replace the expertise of a physician or other healthcare professionals. Responsibility for patient care always remains with the healthcare professional.

Not intended for emergency situations

Duodecim Forms and Calculators are not intended for use in the treatment of critically ill patients or in emergency situations.

The user should be aware of possible errors or omissions in the structured input data

Duodecim Forms and Calculators are dependent on structured data retrieved from the patient information system. Any deficiencies or errors in this data may lead to incomplete or unjustified alerts. Similarly, errors in the data entered into or pre-filled in the calculator may lead to incorrect results. The user is responsible for verifying the accuracy of the entered data.

Disclaimers

Content-related limitations

Users must consider any form- and calculator-specific limitations and ensure that the tool is appropriate for the patient in question.

Version information

Duodecim Forms and Calculators (EBMEDS®) is a class IIa medical device according to the EU MDR 2017/745. Duodecim Clinical Decision Support instructions for use.

UDI-information: UDI 06429810586025(8012)EBMEDSv4.0.3

Version information: EBMEDS 4.0.3, EBMEDS Master Data 3.0.3

Date of manufacture: 2/2025

Use by date: 2 years from the manufacture

The manufacturer is Duodecim Publishing Company Ltd. Address Kaivokatu 8, 00101 Helsinki.


Intended Use

Duodecim Forms and Calculators (EBMEDS®) is a medical device that enables the user to calculate selected formulas needed in clinical practice. Some calculators are also suitable for use by non-professionals (e.g., ISO-BMI, Finriski). The calculators intended for non-professional use are suitable for general personal wellbeing monitoring, and their intended purpose is not medical. Additional information about each calculator, its use, suitability for different patients, and any other limitations can be found alongside the calculator itself.

Warnings

This device does not replace a healthcare professional

Duodecim Forms and Calculators are intended to support healthcare professionals in their decision-making process. It does not replace the expertise of a physician or other healthcare professionals. Responsibility for patient care always remains with the healthcare professional.

Not intended for emergency situations

Duodecim Forms and Calculators are not intended for use in the treatment of critically ill patients or in emergency situations.

The user should be aware of possible errors or omissions in the structured input data

Duodecim Forms and Calculators are dependent on structured data retrieved from the patient information system. Any deficiencies or errors in this data may lead to incomplete or unjustified alerts. Similarly, errors in the data entered into or pre-filled in the calculator may lead to incorrect results. The user is responsible for verifying the accuracy of the entered data.

Disclaimers

Content-related limitations

Users must consider any form- and calculator-specific limitations and ensure that the tool is appropriate for the patient in question.

Version information

Duodecim Forms and Calculators (EBMEDS®) is a class IIa medical device according to the EU MDR 2017/745. Duodecim Clinical Decision Support instructions for use.

UDI-information: UDI 06429810586025(8012)EBMEDSv4.0.3

Version information: EBMEDS 4.0.3, EBMEDS Master Data 3.0.3

Date of manufacture: 2/2025

Use by date: 2 years from the manufacture

The manufacturer is Duodecim Publishing Company Ltd. Address Kaivokatu 8, 00101 Helsinki.


Intended Use

Duodecim Forms and Calculators (EBMEDS®) is a medical device that enables the user to calculate selected formulas needed in clinical practice. Some calculators are also suitable for use by non-professionals (e.g., ISO-BMI, Finriski). The calculators intended for non-professional use are suitable for general personal wellbeing monitoring, and their intended purpose is not medical. Additional information about each calculator, its use, suitability for different patients, and any other limitations can be found alongside the calculator itself.

Warnings

This device does not replace a healthcare professional

Duodecim Forms and Calculators are intended to support healthcare professionals in their decision-making process. It does not replace the expertise of a physician or other healthcare professionals. Responsibility for patient care always remains with the healthcare professional.

Not intended for emergency situations

Duodecim Forms and Calculators are not intended for use in the treatment of critically ill patients or in emergency situations.

The user should be aware of possible errors or omissions in the structured input data

Duodecim Forms and Calculators are dependent on structured data retrieved from the patient information system. Any deficiencies or errors in this data may lead to incomplete or unjustified alerts. Similarly, errors in the data entered into or pre-filled in the calculator may lead to incorrect results. The user is responsible for verifying the accuracy of the entered data.

Disclaimers

Content-related limitations

Users must consider any form- and calculator-specific limitations and ensure that the tool is appropriate for the patient in question.