CNSystems CNAP Monitor 500 HD, Руководство оператора

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General information
CNAP
®
Monitor 500 Page 2-3 Version 5.2.5,
h
21-FHZU-10002
Limitations:
The CNAP
®
Monitor is intended for use in adults and in children from the age of 4 years. This
includes an application to pregnant women including pre-eclampsia patients.
The CNAP
®
Monitor is not intended for use on neonates.
In certain cases, a continuous blood pressure measurement is not reliable and/or not possible:
o
Weak signal shown through perfusion indicator (PI): low PI ≤ 1 on the CNAP
®
Monitor 500
(see chapter 3.7 - PI)
o
Reduced peripheral blood flow (peripheral shock, hypothermia, extreme centralization, ex-
treme hypothermia)
o
Arterial vascular diseases (arteriosclerosis, Raynaud’s syndrome, endarteritis obliterans, col-
lagenosis, extremely advanced vascular diseases PAOD)
o
Edema in the fingers
o
NBP limitations (see below)
NBP
:
•
Under the following conditions there might be a decrease in accuracy of the oscillometric blood
pressure measurement:
o
weak pulse
o
arrhythmia
o
patient movement artifacts
o
tremor artifacts
o
respiratory artifacts
2.3 Disposal
Packaging material
•
The packing material of the CNAP
®
Monitor 500 is to be disposed of according to the respective
national regulations.
Device and accessories
•
Dispose of the CNAP
®
Monitor 500 and any accessories at the end of the products' lifecycles in
accordance with respective national regulations or send the parts back to CNSystems Medi-
zintechnik AG.
2.4 Declaration of intended use
The CNAP
®
Monitor 500 is intended for the non-invasive continuous measurement and display of
blood pressure (blood pressure waveform, beat-to-beat numerics, systolic, diastolic and mean
pressures), and pulse rate in hospitals, clinical institutions, medical practices and outpatient set-
tings. Furthermore, the display of alarms can be set for the parameters of blood pressure and pulse
rate. The CNAP
®
Monitor 500 is to be used for adults and pediatric patients from the age of 4 years
and is to be operated by medical professional staff or persons especially trained for the use of the
device.
The derived measurement Pulse Pressure Variation (CNAP
®
-PPV) is intended for use with sedated
adult patients receiving controlled mechanical ventilation being mainly free from cardiac arrhyth-
mias. The CNAP
®
-PPV measurement has been validated only for adult patients.
The device types CNAP
®
Monitor 500i/at+HD and CNAP
®
Monitor 500 HD also offers the derivation
of Cardiac Output (CO) and additional dependent hemodynamic (HD) parameters derived from the
blood pressure wave. The method was developed for trend measurements that are scaled by bio-
metric calibration. The accuracy of the absolute values can be increased by a manual calibration.
Distributed by BIOPAC Systems, Inc. Manufactured by CNSystems AG