General Information
Operator´s Manual PiCCO
2
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Version 3.1
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General Information
1
Intended Use
The PULSION PiCCO
2
´s intended use is the minimally invasive determination and monitoring of
cardiopulmonary and circulatory variables. Along with other bedside monitors and the clinical evaluation, the
PiCCO
2
detects the patient´s status and evaluates the need for and the suitability of treatment methods for the
care of critically ill patients in intensive care units as well as for perioperative monitoring. If a patient´s correct
weight and height are entered, the PiCCO
2
presents the derived parameters indexed to the patient´s body
characteristics.
The PiCCO
2
uses up to four technologies:
1.
Transpulmonary thermodilution measurement for discontinuous determination of cardiac output and intra-
and extravascular fluid volumes.
2.
Arterial pulse contour analysis for the continuous determination of cardiac output, volume responsiveness
and other derived parameters.
3.
Fiberoptic reflective measurement for the determination of oxygen saturation in the blood.
4.
Pulse oximetry for continuous monitoring of the functional oxygen saturation of arterial haemoglobin
(SpO
2
) and pulse densitometry for the determination of the concentration of Indocyanine Green, a dye
approved as a diagnostic drug.
The transpulmonary thermodilution technique and the arterial pulse contour analysis are not classified as
measuring functions as stated in the Council Directive 93/42/EEC.
The PiCCO
2
is intended for use in hospitals and hospital-like facilities and by trained health care
professionals.
The PiCCO
2
can be used in environments stated in the IEC 60601-1-1 Standard.
2
Indications
The use of the PiCCO
2
is indicated in patients where cardiovascular and circulatory volume status monitoring
is necessary. This includes patients undergoing surgical interventions of such magnitude that cardiovascular
monitoring is necessary.
Continuous monitoring of central venous oxygen saturation is indicated in all intensive care patients
particularly in the case of sepsis and multi-organ failure; management of early goal directed therapy in severe
sepsis; for intra-operative monitoring of high risk surgical patients and in emergency medicine and acute-care
for fast track evaluation of the patient´s haemodynamic condition.
The Indocyanine Green concentration and elimination measurement is indicated in all patients with persistent
or expected limitations of the global liver function (cellular function or perfusion).
