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Appendix
Technical and visual modifications as well as misprints reserved - © 2019 by ERGO-FIT GmbH & Co. KG
Description Blood Pressure Module
Measurement Method auscultatory, RR method, systole detection at the rst
Korotko sound, diastole detection at the last audible
Korotko sound (Kotoko Phase V)
Measurement accuracy meets or exceeds the requirements of DIN EN ISO
81060-2:2014 for non-invasive accuracy (± 5 mmHg mean
deviation, 8 mmHg standard deviation)
Calibration Procedure Measuring accuracy of BL-6 in terms of pressure and
display must be checked every 2 years. (According to the
Medical Device Operator Ordinance, a metrological check
and, if necessary, a calibration procedure must be perfor-
med every 2 years at the latest. Calibration procedure is
only required if the machine did not pass the metrological
check.)
Systole measuring range 40 - 300 mmHg
Diastole measuring range 30 - 160 mmHg
Pulse measuring range 30 - 230 bpM
Static pressure deviation max +/- 3 mmHg
Power supply 12 V DC, 1,2 A
A.4 Electromagnetic Emission and Interference Immunity
CARDIOWISE machines were developed in accordance with DIN EN 60601-1-2: 2015
standard for electromagnetic interference, requirements and tests. This standard provides
basic safety information and covers the essential performance characteristics in the presence
of electromagnetic disturbances and the electromagnetic disturbances emanating from the
medical devices, depending on the electromagnetic environment in which the machines are
used. Locations for the intended use of CARDIOWISE devices are professional healthcare
facilities, except in the vicinity of RF surgical equipment and outside the RF shielded room of
a ME system for magnetic resonance imaging, as well as in home healthcare areas (e.g.
medical practices that are associated with the public supply network).
As is the case with any electrically operated device, 100% fault-free operation cannot be
guaranteed. Interactions or disturbances may occur in certain areas with high intensity
interferences. The following warnings should be observed:
WARNING:
Danger of malfunction!
Avoid operating the machine immediately next to other devices or when stacked
with other devices. If such use becomes necessary, CARDIOWISE equipment and
other equipment must be monitored to ensure proper operation.
Possibility of increased electromagnetic emissions and reduced electromagnetic
immunity of this device! Danger of malfunction! Do not use accessories or cables
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