Boso ABI-system 100 Manual de servicio descargar pdf (Pagina 5)

Introductory information

Your boso ABI-system 100 is an innovation on the market for blood pressure mea-

surement. It represents an easy way to determine the ankle-brachial index (ABI) and

works according to the oscillometric measurement principle. The pressure variations

(oscillations) caused by the pulse waves and transmitted by the cuffs are saved and

evaluated by the microprocessors. The main advantage of this type of measurement

is that there is no need for a microphone or duplicator whose positioning is crucial

in terms of achieving accurate results.

This device complies with the European directives based on the German Medical

Devices Act (label: CE0124) and with European standard EN 1060, part 1: “Non-

invasive sphygmomanometers – general requirements” and part 3: “Supplementary

requirements for electro-mechanical blood pressure measuring systems”.

Technical testing – to be performed every 2 years at the latest – can either be carried

out by the manufacturer, or the authorities or persons responsible for metrology, all

of which must meet the requirements of the Medical Devices Operator Ordinance

§ 6. Technical testing instructions can be found on page 23 of these user

instructions.

Electrical medical devices are subject to specific precautionary measures with regard

to electromagnetic compatibility, and must therefore be installed and operated accor-

ding to the Electronic Compatibility Act information listed on pages 24 and 25.

Important information:

•ThesameexclusioncriteriaapplyfortheoscillometricABImeasurementasfor

the Doppler measurement.

•Thedevicemustneverbeusedonpatientswithseriousheartfailure.

•Onunconscious,helpless,dazedorconfusedpersonstheinstrumentisnotbe

used unattended.

•Thecuffsmustneverbeplacedonopenwounds.

•Thecuffsmustneverbeplacedonimplantedstents.

•Thecuffsmustneverbeplacedonlymphoedemas.

•Theremustbeaperiodofatleast2minutesbetween2consecutive

measurements.

•Irregularheartratedefectscaninterferewiththeaccuracyofameasurementor

lead to incorrect readings. Interference can also occur among people with pace

makers who have a weak pulse. The sphygmomanometer will have no effect on

the pacemaker, however.

•Pregnantwomen,diabeticsandpeoplewithliverproblemsmayexperience

distorted readings.

•Operatingthedeviceinthevicinityofstrongelectromagneticfields(e.g.radiation

appliances, mobile phones) may lead to malfunction (see pages 24 and 25).

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Boso ABI-system 100 Manual de servicio Pagina 5