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9. Certifications

Device standard:

This medical device is manufactured to meet the re-

quirements

European and United States standards for
non-invasive blood pressure monitors
EN1060–1 / 12:95
EN1060–3 / 09:97

DIN 58130, NIBP – clinical investigation
ANSI / AAMI SP10, NIBP - requirements

Electromagnetic compatibility:

Device fulfils the stipulations of the European stan-
dard EN 60601–1–2

Clinical testing:

Clinical performance tests were carried out in the
U.S. and Germany according to the DIN 58130/1997
procedure N6 (sequential) and AAMI. (U.S.)

The stipulations of the EU-Guidelines 93/42/EWG for Medical Products Class IIa have been fulfilled.

Содержание MDS2002

Страница 1: ...acitivo Alcance de medici n SYS DIA 30 a 280 mmHg pulso 40 a 200 por minuto L mites de indicaci n de la presi n de la mu equera 0 299 mmHg Memoria almacenamiento autom tico del ltimo valor medido Reso...

Страница 2: ...pper arm Manual inflate with bulb auto deflate Instruction Manual Tensi metro autom tico Instrucciones de uso PLEASE NOTE THIS MEDICAL INSTRUMENT MUST BE USED ACCORDING TO IN STRUCTIONS TO ENSURE ACCU...

Страница 3: ...3 What can be done if regular high low values are obtained 3 Components of your blood pressure monitor 4 Operation of your blood pressure monitor 4 1 Inserting the batteries 4 2 Tube connection 5 Meas...

Страница 4: ...NIBP investigaci n cl nica ANSI AAMI SP10 NIBP requerimientos Compatibilidad electromagn tica El aparato cumple las especificaciones del est ndar europeo EN 60601 1 2 Ensayo cl nico El test de funcion...

Страница 5: ...orcionarle m s informaci n sobre el particular 8 Garant a El monitor de tensi n arterial MDS2002 tiene una garant a de 2 a os a partir de la fecha de compra Esta garant a incluye el instrumento El bra...

Страница 6: ...place Please contact your doctor for further questions on the subject of blood pressure and its measurement Attention 1 2 Important information about self measurement Self measurement means Control no...

Страница 7: ...ood pressure values lie between 140mmHg and 160mmHg and or the diastolic blood pressure values lie between 90mmHg and 95mmHg Consult your doctor Regular self checks will be neces sary With blood press...

Страница 8: ...icos especialistas en Alemania En cada aparato individual se usa el mismo programa de ordenador por lo que ha sido as comprobado cl nicamente El aparato se ha fabricado de acuerdo con las especificaci...

Страница 9: ...ongase en contacto con su medico si sigue obteniendo lecturas no usuales Otros posibles funcionamientos defectuosos y su soluci n Si aparecen problemas al usar el aparato deben comprobarse los siguien...

Страница 10: ...structurally damaged with increased blood pressure values c There are many different causes of high blood pressure We differentiate between the common primary essential hypertension and secondary hyp...

Страница 11: ...must receive advise regarding the type and extent of exercise that is appro priate for you 3 Components of your blood pressure monitor Your Medline upper arm semi automatic blood pressure monitor cons...

Страница 12: ...azalete tenga la presi n adecuada y la medici n est en curso siga los pasos d e 5 6 Interrupci n de la medici n Si por alguna raz n es necesario interrumpir la medici n de la tensi n arterial p ej el...

Страница 13: ...da Si desconoce este valor nflelo aproximadamente hasta un valor comprendido entre 160 180 mmHg La presi n del brazalete aparece continuamente en la pantalla d Tras el proceso de inflado deje la peril...

Страница 14: ...ly the display may function eratically or not at all Check battery po larity Attention After the low battery indicator appears the device will not function until the batteries have been replaced Pleas...

Страница 15: ...muscles in the measurement arm during measure ment Use a cushion for support and rest your arm on a table If the upper arm artery lies considerably lower or higher than the heart a false higher or low...

Страница 16: ...arteria que recorre la cara interna del brazo d Tense el extremo libre del brazalete y ci rrelo con el Velcro e No debe quedar ning n espacio libre entre el brazo y el brazalete de lo contrario podr a...

Страница 17: ...se est efectuando la medici n durante la misma Si es necesario utilice un almohad n de apoyo Si la arteria braquial se encuentra considerablemente m s baja alta que el coraz n se medir una tensi n ar...

Страница 18: ...inner side of the arm d Tighten the cuff by pulling the end and close the cuff by affixing the velcro e There should be little free space between the arm and the cuff You should able to fit 2 fingers...

Страница 19: ...shown continuously on the display d After the inflation process lay down the pump ball and remain in a quiet and in a relaxed sitting posi tion The measurement now proceeds on its own If no measuremen...

Страница 20: ...n Una vez que aparece el mensaje de advertencia sobre la bater a queda bloqueado el aparato hasta que se sustituyen las pilas Use pilas de 1 5V AA de larga duraci n o alcalinas No se recomienda el uso...

Страница 21: ...ar a practicar deporte El le aconsejar sobre los tipos de deporte apropiados para Ud 3 Los diversos componentes del monitor de tensi n arterial La figura muestra el monitor de tensi n arterial MDS2002...

Страница 22: ...nts d e in section 5 4 5 6 Discontinuing a measurement If it is necessary to interrupt a blood pressure mea surement for any reason e g the patient feels unwell press the quick release valve at the pu...

Страница 23: ...hen the instrument is Check whether the batteries are installed with switched on although the batteries are in place the correct polarity The display is not working properly If the display is unusual...

Страница 24: ...la tensi n arterial a largo plazo el coraz n sufrir da os estructurales c Existen muchas causas diferentes para la aparici n de valores altos de la tensi n arterial Diferenciamos entre la hipertensi...

Страница 25: ...y 160 mmHg y o el valor diast lico de la tensi n arterial est entre 90 mmHg y 95 mmHg consulte igualmente con su m dico Es m s ser necesario efectuar autocontroles de forma regular Con valores de la...

Страница 26: ...Do not use gas thinners or similar solvents Spots on the cuff can be removed carefully with a damp cloth and soapsuds The cuff must not be washed in a dishwasher Clothes washer or submerged in water...

Страница 27: ...owing the operating instruc tions or alterations made to the instrument by third parties Batteries or damage from old batteries is not covered by the warranty Please note Unlike gauge type devices thi...

Страница 28: ...eguntas sobre la tensi n arterial y su medici n Atenci n 1 2 Informaci n importante sobre las automediciones No lo olvide automedici n significa control no diagn stico o tratamiento Los valores inusua...

Страница 29: ...os componentes del monitor de tensi n arterial 4 Puesta en funcionamiento del monitor de tensi n arterial 4 1 Colocaci n de las pilas 4 2 Conexi n del tubo 5 Desarrollo de una medici n 5 1 Antes de la...

Страница 30: ...BP clinical investigation ANSI AAMI SP10 NIBP requirements Electromagnetic compatibility Device fulfils the stipulations of the European stan dard EN 60601 1 2 Clinical testing Clinical performance te...

Страница 31: ...cm 8 11 16 11 13 16 cuff type MDS9873 for arm circumference 30 38 cm 11 13 16 15 Technical alterations reserved Further information Blood pressure is subject to fluctuations even in healthy people Com...

Страница 32: ...Tensi metro semi autom tico Instrucciones de uso 16...

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