PULSION PiCCO2 Operator's Manual And Product Information
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PULSION PiCCO2 Operator's Manual And Product Information

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PULSION Medical Systems SE
Hans-Riedl-Str. 17
D-85622 Feldkirchen
Phone:
+49 - (0)89 - 45 99 14 – 0
Fax
+49 - (0)89 - 45 99 14 – 18
E-mail:
info@pulsion.com
Internet: www.PULSION.com
© PULSION EN 03/2013
Art. No.: PC856EN_R11
PiCCO
(PC8500)
Version 3.1
Operator´s Manual
and
Product Information
2
March 2013

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  • Page 1 PiCCO (PC8500) Version 3.1 Operator´s Manual Product Information PULSION Medical Systems SE Hans-Riedl-Str. 17 D-85622 Feldkirchen Phone: +49 - (0)89 - 45 99 14 – 0 +49 - (0)89 - 45 99 14 – 18 E-mail: info@pulsion.com Internet: www.PULSION.com © PULSION EN 03/2013 March 2013 Art.
  • Page 2 About this Manual About this Manual WARNING: Important items of information, i.e. activities where operating personnel must proceed with extreme caution in order to avoid injury to themselves or the patient. These items of information are always shown in BOLD. CAUTION: Items of information for which careful attention must be paid in order to avoid damage to the equipment or inaccurate data as well as operational errors.

  • Page 3: Table Of Contents

    Table of Contents Table of Contents About this Manual ........................... II Table of Contents ........................... III List of Figures ............................VII A General Information ........................A-1 1 Intended Use ..........................A-1 2 Indications ..........................A-1 3 Contraindications ........................A-2 4 Warnings ..........................A-3 5 Safety instructions ........................
  • Page 4 Table of Contents 4.3.1 ............................B-8 4.3.2 ............................B-8 5 Pulse oximetry and pulse dye densitometry ................B-9 5.1 Principle of pulse oximetry........................B-9 5.2 Principle of pulse dye densitometry ......................B-9 5.3 Principle of ICG elimination detection ....................B-10 5.4 Parameters of pulse oximetry and pulse dye densitometry ..............B-10 6 Parameter groups and ranges of normal values ..............
  • Page 5 Table of Contents 3.7.1 Non-invasive ICG measurement ................... C-19 3.7.2 Display of results ........................C-21 3.7.3 Calculation of ICG quantity ....................C-22 3.8 Thermodilution and calibration of pulse contour analysis ..............C-23 4 Display Options ........................C-27 4.1 Information bar ............................. C-27 4.2 Real time pressure curve ........................
  • Page 6 Table of Contents 8.2 Label Printer ............................C-50 9 Battery Function ........................C-51 10 Cleaning and Disinfection....................... C-52 10.1 General remarks ........................... C-52 10.2 Precautions ............................C-52 10.3 Cleaning ............................... C-53 10.4 Disinfection ............................C-53 D Disposables / Accessories ......................D-1 1 Disposables..........................

  • Page 7: List Of Figures

    List of Figures List of Figures Page Figure 1: Heart-lung circulation and resulting thermodilution curve Figure 2: GEDV / ITBV Figure 3: Extravascular Lung Water (EVLW) Figure 4: Global Ejection Fraction (GEF) Figure 5: Calibration of pulse contour analysis by means of thermodilution Figure 6: SVV Figure 7: PPV Figure 8: dPmx...
  • Page 8 List of Figures Figure 26: "Thermodilution" screen C-23 Figure 27: Selection of “Inj. Volume” option with help screen “Recommended Inj. Volume” C-23 Figure 28: Recommended injectate volume depending on body weight C-25 Figure 29: Thermodilution curve C-26 Figure 30: Real time curve of arterial pressure C-28 Figure 31: Parameter fields C-29...
  • Page 9 General Information A General Information Intended Use The PULSION PiCCO ´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 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.

  • Page 10: A General Information

    General Information Contraindications The invasive technologies in the PiCCO should not be used in patients where the placement of an indwelling arterial catheter or a central venous catheter is contraindicated. The PiCCO should only be used in patients where the expected results are reasonable in comparison to the risks. Patients on intra-aortic balloon counter pulsation (IABP) cannot be monitored with the pulse contour analysis of the device.

  • Page 11: Warnings

    PULSION Medical Systems may be used with the PiCCO Explosion hazard when used in the presence of flammable anesthetics. For safety of operation, only memory sticks and printers approved by PULSION Medical Systems may be used with the PiCCO Positioning / Installation: Position the equipment in such a manner that neither the device nor other equipment attached to the device can fall on the patient.
  • Page 12 General Information If an alarm condition arises while the alarm is suppressed, only the optical warning will be given. During the start up procedure an acoustic sound appears at the end of the activation time. If this sound does not appear no acoustic alarm can take place. External influences: carboxyhaemoglobin can result in incorrect high values for SpO .

  • Page 13: Safety Instructions

    The user must assure him-/herself of the safe and fully functional condition of the equipment before using If the PiCCO appears to be damaged, contact your local PULSION representative. Do not use the PiCCO if the device appears to be damaged.
  • Page 14 General Information Recalibration is recommended with significant changes in haemodynamic conditions, such as volume shifts or changes to medication. If the option of the continuous CVP measurement is not used, CVP should be updated as soon as a new value is obtained to accurately calculate SVR and PCCO. Faulty measurements can be caused by incorrectly placed catheters, interfering signal transmission e.g.

  • Page 15: B Principles Of Measurement And Parameters

    The PULSION PiCCO computes the CO continuously, utilizing an improved arterial pulse contour analysis algorithm. The Pulse Contour Cardiac Output (PCCO) is calibrated by means of a transpulmonary thermodilution measurement.

  • Page 16: Transpulmonary Thermodilution Technique

    Principles of Measurement and Parameters Transpulmonary Thermodilution Technique Principle To accomplish thermodilution determination a known volume of a suitable indicator (at least 10°C below blood temperature) is injected intravenously as quickly as possible. The recorded downstream temperature change is dependent on the flow and the volume through which the cold indicator has passed. As a result, a thermodilution curve can be recorded.

  • Page 17: Transpulmonary Volume Determination

    Principles of Measurement and Parameters Transpulmonary volume determination Specific volumes can be calculated by multiplying cardiac output with characteristic time variables of the thermodilution curve. The parameters can alternatively be displayed as absolute parameters or indexed to the patient´s body characteristics.

  • Page 18: Additional Thermodilution Parameters

    Principles of Measurement and Parameters 2.3.2 EVLW EVLW quantifies the extravascular fluid volume in the lungs. It is used to alert the clinician to the existence or development of pulmonary edema. When measuring lung water the intra-alveolar, intracellular and interstitial lung water are considered.

  • Page 19: Continuous Pulse Contour Analysis

    Principles of Measurement and Parameters Continuous Pulse Contour Analysis Principle The relationship between blood flow out of the aorta and pressure measured near the aorta (femoral artery or other large artery) is determined by the compliance function. The compliance function can therefore be characterized by measuring blood pressure and blood flow (cardiac output) simultaneously.

  • Page 20: Continuous Haemodynamic Determination

    Principles of Measurement and Parameters Continuous haemodynamic determination The following parameters are derived by the PULSION PiCCO , analyzing the arterial pressure curve beat by beat. The parameters can alternatively be displayed as absolute parameters or indexed to the patient´s body characteristics.

  • Page 21: Cpo

    Principles of Measurement and Parameters 3.3.3 SVV / PPV SVV is the variation in stroke volume over a certain time. Figure 6: SVV PPV is the variation in pulse pressure over a certain time. Figure 7: PPV In mechanically ventilated patients without arrhythmias SVV and PPV enable an estimation of the volume responsiveness.

  • Page 22: Central Venous Oximetry

    Principles of Measurement and Parameters Central venous oximetry Principle The PiCCO measures central venous oxygen saturation (ScvO ) by spectrophotometry. Spectrophotometry involves the use of light emitting diodes (LED) that produce light of various wavelengths in red and infrared spectra. The light is transmitted to the blood through a fiberoptic in the probe, reflected off the red blood cells and transmitted back through a separate fiberoptic to an optical module.

  • Page 23: Pulse Oximetry And Pulse Dye Densitometry

    Principles of Measurement and Parameters Pulse oximetry and pulse dye densitometry Principle of pulse oximetry Pulse oximetry measures the percentage oxygen saturation of the haemoglobin. The principle of pulse oximetry is based on the transmission and absorption of light waves in the visible and near-infrared spectrum by haemoglobin.

  • Page 24: Principle Of Icg Elimination Detection

    Principles of Measurement and Parameters Principle of ICG elimination detection ICG has an absorption maximum of approximately 805 nm. The determination of ICG concentration within this range (optical window) is not disturbed by other blood components. The trend in ICG concentration over time is used to calculate the relative change in percent per minute. The plasma disappearance rate (PDR) of ICG is a measure of the excretory capacity of the liver and thus global liver function.

  • Page 25: Parameter Groups And Ranges Of Normal Values

    90 – 100 NOTE PULSION is a medical device manufacturer and does not practice medicine. PULSION does not recommend these values for use on a specific patient. The treating physician is in any case responsible for determining and utilizing the appropriate diagnostic and therapeutic measures for each individual patient.
  • Page 26 Principles of Measurement and Parameters WARNING: The PiCCO equipment may only be regarded as a device providing early warning. If there is an indication of a trend towards de-oxygenation of the patient, blood samples must be taken and tested on a laboratory oximeter in order to arrive at a decision concerning the condition of the patient.

  • Page 27: C Installation And Setup

    If the system check detects a failure, no function will be available and “SERVICE” is displayed on the screen. Turn the PiCCO off and contact your local PULSION representative. Do not attempt to use or repair the PiCCO Operator´s Manual PiCCO Page Version 3.1...
  • Page 28 Installation and setup - Blank page - Page C-2 Operator’s Manual PiCCO Version 3.1...

  • Page 29: Functionality And User Interaction

    Installation and setup Functionality and user interaction Screen elements Figure 12: Screen elements 1) Information bar Information bar for patient and measurement specific information and error messages 2) Real Time pressure curve Permanent display of real time pressure curve of arterial pressure (AP) and central venous pressure (CVP) 3) Parameter fields Configurable parameter fields divided into parameter groups, permanent display of the selected parameters 4) Patient screen...

  • Page 30: Touchscreen

    Installation and setup 2.2.1 Touchscreen Measurement and display options as well as any configuration can be reached directly by touching the respective element on the touch screen. All input can be directly made on the screen. Numerics can be directly entered on the screen by means of a touch keyboard. To switch to another screen just select another element on the screen or use the Main button.

  • Page 31: Navigation Dial And Navigation Keys

    Installation and setup 2.2.3 Navigation dial and navigation keys Back key: Back to previous interaction level. Main key: Back to the last active display screen Navigation dial: The navigation dial can be used alternatively to the touch screen. The currently active position will be displayed by a white frame on the screen.

  • Page 32: Setup And Measurement: Step By Step

    Installation and setup Setup and measurement: Step by step Connectors and connections 3.1.1 Patient cables Connection of the CeVOX module or LiMON module Connection of temperature interface cable for arterial thermodilution catheter and injectate temperature sensor. Connection of pressure transfer cable for arterial pressure (AP) Connection of pressure transfer cable for central venous pressure (CVP)

  • Page 33: Monitor Connections

    Connection for patient data acquisition systems (PDMS) 3) LAN Connection for network devices for printing and data transfer 4) USB ports (2) Connection for external printer and PULSION memory stick 5) Potential equalization Connection for potential equalization cable 6) Mains power connector...

  • Page 34: Patient And Monitor Wiring

    Installation and setup Patient and monitor wiring Figure 16: Patient and monitor wiring Thermodilution measurement, pulse contour analysis and pulse oximetry/densitometry can work independently from central venous oxygen saturation measurement. WARNING: Please consult the instructions for use accompanying the disposables and accessories.

  • Page 35: Thermodilution And Pulse Contour Analysis

    Installation and setup 3.2.1 Thermodilution and Pulse Contour Analysis Disposables: (1) Arterial Thermodilution Catheter: PiCCO catheter Insert thermodilution catheter according to instructions for use. Please ensure that the pressure lumen is completely filled with liquid and that all air is evacuated prior to insertion. (2) Arterial pressure transducer: PiCCO Monitoring kit To be installed according to instructions for use.

  • Page 36: Central Venous Oxygen Saturation

    Set the pressure input channel of bedside monitor to 5µV/V/mmHg. Other settings will lead to incorrect blood pressure values being displayed on the bedside monitor. Also set the pressure input channel of bedside monitor to 5µV/V/mmHg when using PULSION monitoring kits directly connected to the bedside monitor.

  • Page 37: Setup And Start

    If the system check detects a failure, no function will be available and “SERVICE” is displayed on the screen. Turn the PiCCO off and contact your local PULSION representative. Do not attempt to use or repair the PiCCO Operator´s Manual PiCCO Page Version 3.1...

  • Page 38: Enter Patient Data

    Installation and setup Enter patient data Figure 17: Start screen Monitoring of the previous patient can be continued. In this case all previous measurement results will be stored by the monitor. PCCO calibration can be restored up to 15 minutes after the last shutdown of the device.

  • Page 39: Figure 18: Catheter Position

    Installation and setup Confirm catheter position Figure 18: Catheter position When selecting a new patient, and provided that a catheter has already been connected, the "Catheter Position" screen appears. The catheter position must be confirmed and, if necessary, changed. Operator´s Manual PiCCO Page Version 3.1 C-13...

  • Page 40: Figure 19: Input Screen

    Installation and setup If monitoring of a new patient has been started, all previous results will be cleared from the system memory. Figure 19: Input screen NOTE: Correct input of height, weight, category and gender is mandatory for the accuracy of the displayed parameters as well as for the correct indexing of some parameters.

  • Page 41: Zero Adjustment

    Installation and setup Zero adjustment Figure 20: "Zero adjustment" screen 3.5.1 Zero adjustment of arterial pressure (AP) and central venous pressure (CVP) Procedure: Open 3-way-stopcock between pressure transducer and pressure line to ambient pressure. Confirm with the button as soon as a stable value is displayed. Perform the zero adjustment at the bedside monitor.

  • Page 42: Central Venous Oxygen Saturation

    The SQI signal can be affected by the presence of electrosurgical units. Attempt to distance electrocautery equipment and cables from the monitor and plug the power cords into separate circuits if possible. If signal quality problems persist, contact PULSION Medical Systems for assistance.

  • Page 43: Figure 21: "Scvo Calibration" Screen: Blood Sample Withdrawal

    Installation and setup Figure 21: "ScvO calibration" screen: Blood sample withdrawal Figure 22: "ScvO calibration" screen: Input of lab values Procedure: Check proper placement of central venous catheter and CeVOX probe. Check the quality of the signal. Withdraw a sufficient amount of central venous blood from the sideport of the CeVOX probe to avoid intermixture of infusion/injection with the withdrawn blood.

  • Page 44: Sao Input

    Installation and setup The units g/dl or mmol/l can be used for Hb. Alternatively input of Hct is possible (adjustment in measurement configuration, chapter C5.6). During blood gas analysis, all other monitor functions can be operated. When returning to the ScvO screen, the lab values for the respective measurement can be entered.

  • Page 45: Indocyanine Green (Icg) Measurement

    Installation and setup Indocyanine Green (ICG) measurement This option needs to be activated in the measurement configuration tab (refer to chapter C5.6 Measurement configuration) and is only available if a LiMON module is connected to the PiCCO The measurement of Indocyanine Green elimination is non-invasive. The PiCCO automatically detects the connected module.
  • Page 46 Installation and setup Press the START button and wait. The button label changes to STOP and a counter is displayed below the button indicating the remaining time needed for baseline analysis, this will last at least one minute. When message “Inject XXmg” appears, inject the prepared ICG solution into a central or peripheral vein.

  • Page 47: Display Of Results

    Installation and setup 3.7.1.1 ScvO Input Figure 23: ScvO input screen During non-invasive ICG measurement manual input of ScvO and Hb are required for the optional calculation of VO . In this case the button automatically changes to the button. For calculation of DO only input of haemoglobin (Hb) is necessary.

  • Page 48: Calculation Of Icg Quantity

    Installation and setup Following ICG injections A new ICG measurement is only possible when the ICG concentration has decreased to a certain level. The message “Next ICG injection possible hh:mm” is displayed on the screen indicating the time the next ICG measurement is possible.

  • Page 49: Thermodilution And Calibration Of Pulse Contour Analysis

    Installation and setup Thermodilution and calibration of pulse contour analysis Figure 26: "Thermodilution" screen Figure 27: Selection of “Inj. Volume” option with help screen “Recommended Inj. Volume” A thermodilution measurement is necessary to determine the patient´s volume status and to calibrate the pulse contour analysis with reference to the CO value.
  • Page 50 Installation and setup NOTE Central venous pressure (CVP) is required for calibration of continuous cardiac output (PCCO). Before performing a thermodilution measurement, pay attention to a current and plausible value. In cases of a continuous CVP measurement with the PiCCO , the CVP value from the beginning of the thermodilution measurement is used in order to avoid errors due to, for e.g., adjusting the 3-way-stopcock to which the central venous pressure transducer is connected.

  • Page 51: Figure 28: Recommended Injectate Volume Depending On Body Weight

    Installation and setup NOTE The rejection of measurement values is only possible within 10 minutes after the measurement. NOTE In case of T < 0.1°C, the precision of the thermodilution measurement should be further optimized by using cold (< 8°C) and/or more injectate. If no plausible arterial pressure signal is available during a thermodilution measurement, the measurement is not used to calibrate PCCO, but is included in the average for the thermodilution parameters.

  • Page 52: Figure 29: Thermodilution Curve

    Installation and setup Display of results The single TD results are displayed in table form. All measurements of one set must be done directly following each other. The maximum time frame for the measurements is 10 minutes. Older measurements are displayed in grey and not included in the current average. Active values are displayed in white.

  • Page 53: Display Options

    Installation and setup Display Options (see Figure 12: Screen elements) The parameter fields on the right, the information bar and the real time pressure curve are displayed permanently. Extended display options for parameters are accessible in the patient screen. The default setting provides the basic and commonly used parameters. All necessary modifications and settings are effected by selecting the respective graphic element.

  • Page 54: Real Time Pressure Curve

    Installation and setup Real time pressure curve Figure 30: Real time curve of arterial pressure Curve and pressure display Arterial pressure is continuously displayed as pressure curve. The numeric values for heart rate, systolic, diastolic and mean arterial pressure are displayed. Systolic marker of arterial pressure The systolic part of each heart beat is marked by a bar under the curve.

  • Page 55: Parameter Fields

    Installation and setup Parameter fields Figure 31: Parameter fields The arrangement of the PiCCO parameter fields is function-specific. Additionally other parameters can be configured along side the main parameter of each group. Selection of the parameter field on the touch screen directly leads to parameter configuration. NOTE Discontinuous parameters are marked with the time indicator symbol .

  • Page 56: Profiles

    The option "Overview" shows the main parameters. The organ specific parameters can be displayed by selection of the respective option. The marked normal value ranges can be modified. Please contact your PULSION representative to individually modify the normal values range.

  • Page 57: Spidervision

    Installation and setup SpiderVision The PULSION SpiderVision diagram shows all continuous parameters in dynamic conjunction. Selection of the SpiderVision diagram on the touch screen directly leads to individual configuration. The brighter marked areas highlight the normal or target value for the respective parameter.

  • Page 58: Trend

    Installation and setup Trend Figure 34: "Trend" screen The number of trends as well as the trend time span of the PiCCO parameters can be configured individually. Selection of a trend curve on the touch screen directly leads to individual configuration. If more than 4 trends are configured at the same time, the arrow keys on the right side of the screen can be used for scrolling up or down the trends.

  • Page 59: Monitor And Display Configuration

    Installation and setup Monitor and Display Configuration The PiCCO has a configuration level in order to arrange individual settings. By selecting the respective function the corresponding option in the configuration menu is opened. A direct change between the single configuration options is possible. Patient settings Figure 35: "Patient settings"...

  • Page 60: Predicted Body Weight

    Installation and setup Category adult / pediatric In marginal cases the decision about the correct category for the individual patient must be based on their anatomy and appearance (habitus). For further information please refer to chapter E5 Equations for Calculated Values. Gender male / female 5.1.2 Predicted body weight...

  • Page 61: Configuration Of Parameter Display

    Installation and setup Keytones The keytones (ON/OFF) are initiated when touching elements on the screen, the device or the navigation dial. The current setting is retained even if the equipment is switched off. Alarm The volume of the acoustic alarm. For safety reasons the settings are adjusted to 75% with every new patient. Brightness The selection of brightness of the screen can be done manually.

  • Page 62: Setting Of Alarm Limits

    Installation and setup 5.3.1 Setting of alarm limits Adjusting of alarm limits Alarm limits can be set for the parameters PCCO and ScvO . Upper and lower alarm limits have to be determined. These alarm limits are returned to the default setting with every new patient. Display alarm limits Yes / No Display of alarm limits directly next to the respective parameter on the right side of the screen.

  • Page 63: Parameter Settings

    PCCI, SVI, CI GEDI GEDI, SVV SVRI SVRI GEF, dPmx ELWI, CPI, TB ELWI, PVPI, CPI, TB ScvO2, DO2, VO2 ScvO2, DO2, VO2 Please contact your PULSION representative to individually modify the parameter profiles. Operator´s Manual PiCCO Page Version 3.1 C-37...

  • Page 64: Spider Configuration

    Installation and setup Spider configuration Figure 38: "Spider configuration" screen The SpiderVision diagram can be configured individually: First select the number of spider legs (3 to 7) Select the parameter to be placed (left) Select the spider leg where the parameter should be placed The spider configuration can be opened by direct selection of the spider diagram.

  • Page 65: Trend Configuration

    Installation and setup Trend configuration Figure 39: "Trend configuration" screen The trend display can be configured individually. A maximum of 8 parameter trends can be displayed. Select the parameter which should be displayed as a trend. Select the position where the parameter trend should be displayed. The trend configuration is opened by direct selection of the trend diagram.

  • Page 66: Measurement Configuration

    Installation and setup Measurement configuration Figure 40: "Measurement configuration" screen The measurement configuration can be directly accessed from the respective measurement screen. 5.6.1 Configuration of thermodilution measurement Art. Catheter Automatic detection and display of the connected thermodilution catheter. If a new PiCCO catheter type is not automatically recognized by the device, it is necessary to enter the ACC (Arterial Catheter Constant, indicated on the connector of the PiCCO catheter).

  • Page 67: Configuration Of Central Venous Catheter

    Installation and setup 5.6.2 Configuration of central venous catheter Setting of the individual injection site and injectate volume for the central venous catheter. New in version 3.1: Inj. Site: V. Jug./Subcl. / V. Femoralis Selection of the injection site. Default setting is V. Jug./Subcl. Inj.

  • Page 68: Normal And Target Values

    Installation and setup Normal and Target Values The allocation of target values is accessible via the menu "Normal values" of the help function or the parameter configuration. When pressing the "Adjust" button, a screen opens with a list of normal parameter values.

  • Page 69: Alarms, Messages And Troubleshooting

    Installation and setup Alarms, messages and troubleshooting The PiCCO displays alarms, warnings and additional important information with different priorities. Categories: Priority Meaning Display Alarm: Emergency, immediate Red blinking text display, acoustic response necessary alarm, blinking LEDs Error messages, response necessary Yellow text display Additional information Grey text display...

  • Page 70: Alarms

    Installation and setup Alarms Alarms are displayed with priority 1, error messages with lower priority are overridden. Alarm Cause Remedy PCCO / PCCI > alarm limit High PCCO / PCCI PCCO / PCCI < alarm limit Low PCCO / PCCI ScvO >...
  • Page 71 Installation and setup Time of injection longer than Repeat injection rapidly Injection Error - Inject faster than 10 seconds and smoothly 10 s Calculation error of MTt / DSt Eliminate interference and TD Curve Error - Stabilize patient caused by temperature repeat injection temperature and repeat injection interferences...
  • Page 72 Installation and setup Implausible value due to Check probe, position and Implausible ScvO value - defect or interference optical module and repeat Recalibrate the monitor calibration. Internal electronic problem in If necessary replace Error Optical Module - optical module optical module Check/Replace optical module / PDR Error Message...

  • Page 73: Additional Information

    Installation and setup Additional information Helpful additional and status information are also displayed in the information bar after performed or expected action. Message / Display Is displayed at following actions Print key Press print key Printout in process After printout is completed Printout ready After detection of a USB device USB device detected...
  • Page 74 Installation and setup Unstable pressure (>5 mmHg/s) during zero Zero adjustment failed - Close stopcock adjustment Pressing AP >0< button Zero adjustment of AP successful Pressing CVP >0< button Zero adjustment of CVP successful Pressing PAP >0< button Zero adjustment of PAP successful No initial zero adjustment of AP and CVP Zero adjustment necessary Trend...

  • Page 75: Help Functions

    Installation and setup Help Functions The help function offers information relating to installation and operation. It can be accessed during monitoring by pressing the key. Furthermore, information on monitor status (software or hardware version) can be obtained. Components: Setup: Setup Guide PiCCO (see Figure 16) Normal Values/Target Values: This tab details the normal value ranges / target value ranges of the individual values.

  • Page 76: Printout

    “Screenshots” folder. The file has the same timestamp as the corresponding PDF file. Label Printer By means of the optional PULSION Printer (PC85300) a printout can be made for filing or placing into the patient file. The printer is connected at the USB port on the back of the PiCCO and it is recognized automatically when starting the monitor.

  • Page 77: Battery Function

    If the operating time of the fully charged battery drops below 30 minutes, or the remaining operating time after the battery alarm has started (a red blinking battery symbol) drops below 7 minutes, contact your PULSION representative to replace the internal battery. Ensure that the batteries are disposed of correctly after expiration of battery life.

  • Page 78: Cleaning And Disinfection

    PULSION approved substances and methods listed in this chapter may be used. PULSION makes no claims regarding the efficacy of the listed chemicals or methods as a means of controlling infection. Please consult your hospital´s Infection Control Officer or Epidemiologist.

  • Page 79: Cleaning

    Installation and setup 10.3 Cleaning When cleaning the PiCCO , please proceed as follows: Clean the surface of the PiCCO with a soft, lint-free cloth moistened with warm water (40°C/104°F maximum) and soap, a diluted non-caustic detergent, tenside, ammonia- or alcohol-based cleaning agent.
  • Page 80 Installation and setup - Blank page - Page C-54 Operator’s Manual PiCCO Version 3.1...

  • Page 81: D Disposables / Accessories

    Disposables WARNING: For safety of operation and for accuracy of measurements, only disposables and accessories approved by PULSION Medical Systems may be used with the PiCCO Reuse of disposable items is not allowed. Re-sterilization of disposables may cause infections in the patient.

  • Page 82: Picco Monitoring Kits

    Disposables / Accessories WARNING: When placing the arterial catheter into a large artery (e.g. femoral, brachial or axillary artery) do not advance the tip of the catheter into the aorta. An intracardiac blood pressure measurement is not allowed. This means that the measuring position (catheter tip) must not be directly in the heart.

  • Page 83: Cevox Probe

    Disposables / Accessories CeVOX probe The PULSION CeVOX fiberoptic probes have been specifically developed for use with the PULSION optical module. The probes are equipped with fiberoptics to transfer light at a specific wavelength. For continuous oxygen saturation monitoring the probe is inserted into the distal lumen of an already placed central venous catheter.

  • Page 84: Accessories

    Disposables / Accessories Accessories Article number Description PC8500 PiCCO Monitor PC80150 Arterial connection cable and injectate temperature interface cable PC80109 Injectate sensor cable PMK-206 Pressure connection cable PC85200 PiCCO AUX Adapter 401090 Mains power cable (240V) 401080 Potential equalization cable PC3010 / PC3015 CeVOX module PC5100...

  • Page 85: E Appendix

    Appendix E Appendix Technical Data General Equipment PiCCO Article number PC8500 Equipment Class Equipment Type Type BF: ScvO Type CF: CO, AP, CVP; all defibrillation-proof Protection Class: Accessories PiCCO catheter and kits Please consult accompanying instructions for use of the PiCCO catheter Arterial connection cable and injectate temperature Art.
  • Page 86 Appendix Battery Operating Time > 30min Operating Conditions Temperature Range 10 °C to 40 °C (50 °F to 104 °F) Relative Humidity 75% (non-condensing) Ambient Pressure 700 hPa to 1060 hPa Transport and Storage Conditions Temperature Range -20 to 60°C (-4°F to 140°F), (with rechargeable battery -20 to 50°C (-4°F to 122°F)) Relative Humidity 90% (non-condensing)
  • Page 87 Appendix Measured Parameters: Label Unit Lower limit Upper limit Accuracy PCCO l/min 0.25 25.0 Coefficient of variation ≤ 2 %* Coefficient of variation ≤ 2 %* l/min 0.25 25.0 Coefficient of variation ≤ 2 %* GEDV 4800 Coefficient of variation ≤ 3 %* ITBV 6000 Coefficient of variation ≤...

  • Page 88: Maintenance And Service

    For telephone inquiries relating to service, technical support, accessories or other matters contact PULSION Medical Systems SE. To respond to questions, PULSION Medical Systems SE will need the serial number of the device that is found on the rear panel of the PiCCO PULSION Medical Systems SE Hans-Riedl-Str.

  • Page 89: Disposal Of Electrical And Electronic Equipment

    Appendix Disposal of electrical and electronic equipment The 2012/19/EU Directive aims to increase the separate collection, reuse, recovery and recycling of waste from electrical and electronic equipment. This directive applies to all electrical and electronic appliances as well as to medical devices. As a medical device, the PiCCO is subject to this directive and is labelled with the symbol of the crossed-out wheeled bin.

  • Page 90: Interfaces

    Connection for network devices for printing and data transfer. Serial Interface RS232 Connection for patient data management systems (PDMS) Please contact your PULSION representative for current technical information. USB ports (2) Connection for external printer and PULSION memory stick. The interfaces are galvanically isolated by an isolation voltage of 1.5kV (IEC 60601-1).

  • Page 91: Emc-Requirements

    Appendix EMC-Requirements Table 1 – Guidance and manufacturer´s declaration – electromagnetic emissions (EN 60601-1-2:2007; 5.2.2.1 c) Guidance and manufacturer´s declaration – electromagnetic emissions The PiCCO is intended for use in the electromagnetic environment specified below. The customer or the user of the PiCCO should assure that it is used in such an environment.
  • Page 92 Appendix Table 2 – Guidance and manufacturer´s declaration – electromagnetic immunity (EN 60601-1-2:2007; 5.2.2.1 f) Guidance and manufacturer's declaration - electromagnetic immunity The PiCCO is intended for use in the electromagnetic environment specified below. The customer or the user of the PiCCO should assure that it is used in such an environment.
  • Page 93 Appendix Table 3 – Guidance and manufacturer´s declaration – electromagnetic immunity (EN 60601-1-2:2007; 5.2.2.2) Guidance and manufacturer's declaration - electromagnetic immunity The PiCCO is intended for use in the electromagnetic environment specified below. The customer or the user of the PiCCO should assure that it is used in such an environment.
  • Page 94 Appendix Table 6 – Recommended separation distances between portable and mobile RF communications equipment and the PiCCO (EN 60601-1-2:2007; 5.2.2.2) Recommended separation distances between portable and mobile RF communications equipment and the PiCCO The PiCCO is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the PiCCO can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the PiCCO...

  • Page 95: Equations For Calculated Values

    Appendix Equations for Calculated Values This chapter contains the equations the PiCCO uses to calculate the displayed values. General For the indexing of volumetric parameters the PiCCO uses the following calculated parameters, dependent on body characteristics: Body Surface Area (m²) Depending on the actual entered body weight (BW) different formulas are used for adult and pediatric patients: x height...

  • Page 96: Output

    Appendix Output PCCO = cal HR [P(t) / SVR + C(P) dP/dt] dt where PCCO Pulse Contour Cardiac Output (l/min) Patient specific calibration factor (determined by thermodilution) Heart Rate (1/min) P(t) / SVR Area under pressure curve C(P) Characteristic compliance of the aorta (determined by thermodilution) dP/dt Shape of pressure curve...

  • Page 97: Preload Volume

    Appendix CO = [(Tb – Ti) Vi K] / [ Tb dt] where Cardiac Output (l/min) Blood temperature before the injection of cold bolus (°C) Temperature of the injection solution (injectate) (°C) Injection volume (ml) Tb dt Area under the thermodilution curve Correction constants, made up of specific weights and specific heat of blood and injectate CI= CO / BSA...

  • Page 98: Afterload

    Appendix ITBVI = ITBV / PBSA where ITBVI Intrathoracic Blood Volume Index (ml/m ITBV Intrathoracic Blood Volume (ml) PBSA Predicted Body Surface Area (m²) SVV = (SV – SV ) / SV mean where Stroke Volume Variation (%) Mean value of 4 maximum stroke volumes of the last 30 seconds (ml) Mean value of 4 minimum stroke volumes of the last 30 seconds (ml)

  • Page 99: Contractility

    Appendix Contractility CFI = CO 1000 / GEDV where Cardiac Function Index (1/min) Cardiac Output (l/min) GEDV Global End-Diastolic Volume (ml) GEF = 4 SV / GEDV where Global Ejection Fraction (%) Stroke Volume (ml) GEDV Global End-Diastolic Volume (ml) Organ Function EVLW = ITTV –...

  • Page 100: Oxygenation

    Half life of ICG-PULSION R15 = C 100 % where ICG Retention rate after 15 minutes (%) Concentration of ICG-PULSION after 15 minutes Back-extrapolated concentration of ICG-PULSION at Time 0 Oxygenation ScvO = [HbO 100] / [HbO + Hb where...
  • Page 101 Appendix I = 1.34 Hb (SaO – ScvO ) PCCI 10 where Oxygen Consumption Index (ml/min/m Concentration of haemoglobin (g/dl) Arterial Oxygen Saturation (%) ScvO Central Venous Oxygen Saturation (%) PCCI Pulse Contour Cardiac Output Index (l/min/m = HbO / [HbO + Hb where Partial arterial oxygen saturation (%)

  • Page 102: Flow Chart

    Appendix Flow chart Page E-18 Operator’s Manual PiCCO Version 3.1...

  • Page 103: Symbols

    Appendix Symbols ON/OFF Key Help key Print key Mute key Main key: Back to the last active screen display Back key: Back to previous interaction level Attention, consult accompanying operator’s manual Equipment Type BF, protected against defibrillation Equipment Type CF, protected against defibrillation Symbol for battery status Time indicator for parameters which are not continuously derived Loudspeaker...

  • Page 104: Warranty

    , if disposables and accessories are used with the PiCCO which are not approved by PULSION. In the context of this guarantee, PULSION is not obliged to repair or replace a damaged or faulty PiCCO , if the damage or the faulty performance results from the user employing disposables and accessories which are not approved by PULSION.
  • Page 105 US6491640, JP3375590, US6394961, EP0983745, US6264613, JP2000102622 EP0505918, EP0557492, EP1022984, US6640129, JP4322227, US7588542 Further patents pending Certification according to Annex II of Directive No. 93/42/EEC for medical devices. Copyright © 2013 PULSION Medical Systems SE. All rights reserved. Operator´s Manual PiCCO Page Version 3.1 E-21...

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