BC Biomedical NIBP-1010 Manual de usuario descargar pdf (Pagina 13)

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becomes fully transitory again, and the Korotkov murmurs fade away. At this moment, we

read the current pressure value, and it is the diastolic pressure value.

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Generallegislationregardingtonometers

 Validation of tonometers abides by Law No. 505/1990 Coll., as amended by No.

119/2000 Coll. and subsequent modifications by Law No. 137/2002 Coll. According to the

public notice (decree) No. 345/2002 Coll., tonometer is an assigned gauge subject to

validation after every two years.

Periodic revisions of medical devices (including tonometers) - electric and non-electric

medical devices - are given by Law No. 123/2000 Coll., as amended by No. 130/2003 Coll.,

and subsequently modified by Law No. 346/2003 Coll. At first, revisional inspections were

carried out by the manufacturer or the service organizations providing for repairs of medical

devices. The organizations carried out the revisional inspections within the framework of their

trade licence for “manufacturing and repairs of medical apparatus” and after passing an

examination according to public notice (decree) No. 50/1978 Coll.

Current legal state clearly defines the rules of who and under what conditions can

carry out the revisional inspections. This issue is regulated by Law No. 124/2000 Coll. and by

amended standards ČSN EN 60601-1-2 and ČSN EN 62 353. State Office for Drug Control

(SÚKL) in Prague, General Health Insurance Company (VZP), Czech Metrological Institute

(ČMI) and Czech Commercial Inspection (ČOI) are entitled to carry out inspections, together

with the State Office for Labour Inspections (since 2005) in Prague.

At present, the revisional inspections can only be carried out by a person with

authorization granted by the Institute of Technical Inspection (ITI) in Prague for carrying out

this type of work, on the basis of which a trade licence was issued for such person for

assembly, repairs, revisions and inspections of assigned devices. The actual revisional

inspection may only be carried out by a natural person with a state examination passed at ITI

Prague and with a certificate of a revisional technician.

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Theaimandthecontentsofthemeasurements

 The aim of the measurement will be to verify the accuracy of tonometers with

different principles and construction. In classical mercury, pseudo-mercury and aneroid

tonometers, it will be followed by the formation of a calibration curve based on the measured

deviations compared to standardized gauges (NIBP simulator). In automatic and semi-

automatic gauges, only the accuracy dedicated by the manufacturer regarding pressure and

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BC Biomedical NIBP-1010 Manual de usuario Pagina 13