PiCCO2 Operators Manual and Product Information Ver 1.x

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. These items of information are always shown in BOLD.

WARNING: Read the operating instructions carefully before using the PiCCO2 equipment!

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Operator’s Manual PiCCO2 Version1.x

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-1

4

Warnings... A-2

5

Safety instructions... A-4

B Principles of Measurement and Parameters ...B-1 1

Introduction ... B-1

2

Transpulmonary Thermodilution Technique... B-2 2.1 Priniciple... B-2 2.2 Transpulmonary Cardiac Output ... B-2 2.3 Transpulmonary volume determination ... B-3

3

2.3.1

GEDV / ITBV ... B-3

2.3.2

GEF / CFI ... B-4

2.3.3

EVLW ... B-4

2.3.4

PVPI ... B-4

Continuous Pulse Contour Analysis... B-5 3.1 Priniciple... B-5 3.2 Calibration of the Pulse Contour Cardiac Output ... B-5 3.3 Continuous hemodynamic determination ... B-6

4

3.3.1

MAP / CVP / HR ... B-6

3.3.2

PCCO ... B-6

3.3.3

SVV / PPV ... B-7

3.3.4

SVR ... B-7

3.3.5

CPO... B-7

3.3.6

dPmx ... B-7

Central venous oximetry ... B-8 4.1 Priniciple... B-8 4.2 Determination of ScvO2 ... B-8

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Table of Contents

5

Oxygen delivery and oxygen consumption: DO2 and VO2 ...B-9 5.1 DO2 ...B-9 5.2 VO2 ...B-9

6

Parameter groups and ranges of normal values ...B-10

C Installation and Setup ...C-1 1

Unpacking and Inspection...C-1

2

Functionality and user interaction...C-3 2.1 Screen elements ... C-3 2.2 User interaction ... C-3

3

2.2.1

Touch screen... C-4

2.2.2

Function keys ... C-4

2.2.3

Navigation dial and navigation keys ... C-5

Setup and measurement: Step by step ...C-6 3.1 Connectors and connections... C-6 3.1.1

Patient cables... C-6

3.1.2

Monitor connections ... C-7

3.2 Patient and monitor wiring... C-8 3.2.1

Thermodilution and Pulse Contour Analysis... C-9

3.2.2

Central venous oxygen saturation... C-10

3.2.3

Application of Injectate temperature sensor housing and CeVOX probe at the same time... C-10

3.2.4

Transmission of continuous pressure to bedside monitor ... C-10

3.3 Setup and start ... C-11 3.3.1

Mains voltage ... C-11

3.3.2

Switch on the device ... C-11

3.4 Enter patient data ... C-12 3.5 Zero adjustment ... C-14 3.6 Central venous oxygen saturation... C-15 3.6.1

ScvO2 calibration... C-15

3.6.2

SaO2 Input ... C-17

3.7 Thermodilution and calibration of pulse contour analysis... C-18

4

Display Options ...C-22 4.1 Information bar ... C-22 4.2 Real time pressure curve... C-23 4.3 Parameter fields ... C-24

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Operator’s Manual PiCCO2 Version1.x

Table of Contents 4.4 Profiles... C-25 4.5 SpiderVision ... C-26 4.6 Trend ... C-27

5

Monitor and Display Configuration ...C-28 5.1 Patient settings... C-28 5.1.1

Information input... C-28

5.1.2

Predicted body weight ... C-29

5.2 Monitor settings ... C-29 5.3 Configuration of parameter display... C-30 5.3.1

Settings of alarm limits ... C-30

5.3.2

Parameter settings ... C-30

5.4 Spider configuration... C-31 5.5 Trend configuration... C-32 5.6 Measurement configuration ... C-33

6

5.6.1

Configuration of thermodilution measurement... C-33

5.6.2

Configuration of ScvO2 measurement ... C-33

Alarms, messages and troubleshooting ...C-34 6.1 Alarms ... C-35 6.2 Error Messages ... C-35 6.3 Additional information... C-37

7

Help Functions ...C-39

8

Printout ...C-40 8.1 USB Data Printing Option... C-40 8.2 Label Printer ... C-40

9

Battery Function...C-41

10 Cleaning and Disinfection ...C-42 D Disposables / Accessories ...D-1 1

Disposables ...D-1 1.1 PiCCO Catheter (arterial thermodilution catheter)... D-1 1.2 PiCCO Monitoring Kits... D-2 1.3 Injectate Temperature Sensor Housing... D-2 1.4 CeVOX probe ... D-3

2

Accessories...D-4

E Appendix ... E-1

Operator´s Manual PiCCO2 Version 1.x

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Table of Contents

1

Technical Data ...E-1

2

Maintenance and Service...E-4 2.1 Classification ...E-4 2.2 Maintenance...E-4 2.3 Disposal of electrical and electronic equipment ...E-5

3

Interfaces ...E-6

4

EMC-Requirements...E-7

5

Equations for Calculated Values ...E-11 5.1 General...E-11 5.2 Flow...E-12 5.3 Volume ...E-13 5.4 Organ Function...E-15 5.5 Oxygenation ...E-16

6

Flow chart ...E-17

7

Symbols ...E-18

8

Warranty ...E-19

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Operator’s Manual PiCCO2 Version1.x

List of Figures

List of Figures Page Figure 1: Heart-lung circulation and resulting thermodilution curve

B-2

Figure 2: GEDV / ITBV

B-3

Figure 3: Global Ejection Fraction (GEF)

B-4

Figure 4: Extravascular Lung Water (EVLW)

B-4

Figure 5: Calibration of pulse contour analysis by means of thermodilution

B-5

Figure 6: SVV

B-7

Figure 7: PPV

B-7

Figure 8: dPmx

B-7

Figure 9: The principle of spectrophotometry

B-8

Figure 10: Screen elements

C-3

Figure 11: Function keys

C-4

Figure 12: Patient socket with equipment class (defibrillator protection)

C-6

Figure 13: Monitor connections

C-7

Figure 14: Patient and monitor wiring

C-8

Figure 15: Start screen

C-12

Figure 16: Input screen

C-12

Figure 17: "Zero adjustment" screen

C-14

Figure 18: "ScvO2 calibration" screen: Blood sample withdrawal

C-16

Figure 19: "ScvO2 calibration" screen: Input of lab values

C-16

Figure 20: "Thermodilution" screen

C-18

Figure 21: Recommended injectate volume depending on body weight and ELWI

C-20

Figure 22: Thermodilutioncurve

C-20

Figure 23: Real time curve of arterial pressure

C-23

Figure 24: Parameter fields

C-24

Figure 25: "Profiles" screen

C-25

Figure 26: "Spiders" screen

C-26

Figure 27: "Trend" screen

C-27

Figure 28: "Patient settings" screen

C-28

Figure 29: "Monitor settings" screen

C-29

Figure 30: "Parameter configuration" screen

C-30

Operator´s Manual PiCCO2 Version 1.x

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List of Figures Figure 31: "Spider configuration" screen

C-31

Figure 32: "Trend configuration" screen

C-32

Figure 33: "Measurement configuration" screen

C-33

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Operator’s Manual PiCCO2 Version1.x

General Information

A

General Information

1

Intended Use The PULSION PiCCO2 intended use is the determination and monitoring of cardiopulmonary and circulatory variables. Cardiac output is determined both intermittently through the transpulmonary thermodilution technique and continuously through arterial pulse contour analysis. Analysis of the thermodilution curve in terms of mean transit time (MTt) and exponential downslope time (DSt) is used for determination of intra- and extravascular fluid volumes. 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. Moreover the PiCCO2 enables the continuous measurement of central venous oxygen saturation via a fibre optic probe. If a patient´s weight and height are entered, the PiCCO2 presents the derived parameters indexed to the patient´s body characteristics. The PiCCO2 is intended for use in hospitals and hospital-like facilities and by trained health care professionals.

2

Indications The use of the PiCCO2 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 evaluation and optimization of ventilation modes and for intra-operative monitoring of high risk surgical patients and in emergency medicine and acute-care for fast track evaluation of the patient´s hemodynamic condition.

3

Contraindications Due to the invasiveness of the measurement, the PiCCO2 should not be used in patients where the placement of an indwelling arterial catheter or a central venous catheter is contraindicated. The PiCCO2 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. Transpulmonary thermodilution however works during IABP support.

WARNING: Federal (USA) law restricts this device to sale by or on the order of a physician. The device is intended for use in hospitals and hospital-like facilities by trained and informed health care professionals.

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General Information

4

Warnings WARNING

General: Federal (USA) law restricts this device to sale by or on the order of a physician. The device is intended for use in hospitals and hospital-like facilities by trained and informed health care professionals. Before using the PiCCO2 equipment carefully read the operating instructions for the device and the required disposables. The use of the PiCCO2 in contradiction to the instructions in this manual may cause undue equipment failure and possible health hazards. For safety of operation and for accuracy of measurements, only disposables and accessories approved by PULSION Medical Systems may be used with the PiCCO2. Explosion hazard when used in the presence of flammable anesthetics.

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. Never lift or carry the device by the mains supply cable or the cables attached to the patient. When using the provided mounting accessories ensure correct installation. The used system must be sufficiently stable and tilt resistant as well as medically approved. In order to ensure a secure connection with the mounting system the locking mechanism of the universal adapter plate must be completely snapped in place. Place the cables attached to the patient carefully so that the patient is not in danger of becoming entangled or strangulating him/herself with the cables. Medical: The device enables the monitoring of physiological parameters. The clinical significance of changes in the monitored parameters must be determined by a physician. If a new patient is to be connected to the device without the device being shut down, the procedure "New Patient" must be selected. Otherwise data from the last patient is still displayed. The PiCCO2 may only be regarded as an early warning device. 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. The device must not be used for monitoring breathing. The device must not be used for monitoring heart rate, arterial blood pressure and body temperature. Before using the device the setting of the alarm limits and the alarm volume must be checked for their suitability for the respective patient. If an alarm condition arises while the alarm is suppressed, only the optical warning will be given.

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Operator’s Manual PiCCO2 Version1.x

General Information 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. Dye (e.g. Indocyanine Green) or other substances which contain dyes which usually modify the blood pigmentation, can lead to faulty measurement values of the oxygen saturation. Do not use the device while a MRI scan is being carried out. Induced voltage can result in potential burns.

Disposables: When placing the arterial catheter into a large artery (e.g. femoral, brachial or axillary) 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 (i.e.catheter tip) should not be in the heart. Reuse of disposable items is not allowed. Re-sterilization of disposables may cause infections in the patient. Incorrect use of the ScvO2 probe can lead to vessel perforation. Therefore check the correct position of the probe as indicated in the probe´s instructions for use.

Electrical: Do not use damaged probes or patient cables. Do not use any probes with exposed optical or electrical components. Do not reconnect the PiCCO2 to electrical power if liquid has entered the device. A short circuit may damage the device and cause hazardous conditions for patient and user. Remove patient cables which are not needed. The user components are not galvanically isolated from each other. The PiCCO2 must always be connected with the protective earth conductor. Never use mains supply cables or extension lines without protective earth conductors. Connect the potential equalization at the back of the device with the potential equalization system of the treatment room.

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General Information

5

Safety instructions CAUTION

General: Do not expose the PiCCO2 to temperatures above 40 °C or below 10 °C. The accuracy of the measured values may be affected. Do not pull on the probes or cables in order to remove them from the device. Observe the instructions for use for the probes in order to ensure that a technically correct procedure is carried out. Do not place other equipment or containers with liquid on top of the PiCCO2. Never place the cables in water or other cleaning solutions. The cables and connections are not watertight. Never sterilize the cables by radiation, steam or gas. Do not use abrasive or sharp-edged tools to clean the optical module as this may damage or destroy the optical components. If the device is not standing on a slip-proof surface and to prevent displacement, hold the unit securely while the function keys are being pressed.

Preparations for Use: The user must assure him-/herself of the safe and fully functional condition of the equipment before using it. If the PiCCO2 appears to be damaged, contact your local PULSION representative. Do not use the PiCCO2 if the device appears to be damaged. If the system check detects a failure, no function will be available and “SERVICE” is displayed on the screen. Turn the PiCCO2 off and contact your local PULSION representative. Do not attempt to use or repair the PiCCO2. When the PiCCO2 is connected to a bedside monitor, perform a zero adjustment of the PiCCO2 before zeroing the bedside monitor.

Medical: If the zero adjustment is not performed, the blood pressure values may be wrong. Zero adjustment of the pressure transducer is mandatory. In the PCCO and ScvO2 calibration menu an old calibration factor may be used. Ensure that the values are plausible after having selected this option. If the displayed pulse contour parameters are not plausible, they should be checked by a thermodilution measurement. The pulse contour cardiac output measurement will be recalibrated automatically. As the pulse contour cardiac output of children has not been sufficiently validated so far the CO should be checked by thermodilution before therapeutic interventions.

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Operator’s Manual PiCCO2 Version1.x

General Information Recalibration is recommended with significant changes in hemodynamic conditions, such as volume shifts or changes to medication. If the option of 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. of arterial pressure, defective connections or sensors or by electromagnetic interference (e.g. electric blankets, electric coagulation). Aortic aneurysms may cause the displayed blood volume (GEDV/ITBV) derived by thermodilution measurement to be erroneously high.

Electrical: The PiCCO2 is subject to specific precautions concerning EMC (Electromagnetic Compatibility) and is only allowed to be installed and used according the EMC advice contained in this user´s manual. Portable and mobile high frequency communication devices may influence the PiCCO2. Any additional item of equipment which is connected to the digital interface must satisfy the EMC requirements of the IEC specification 60601-1-2. Furthermore, all configurations have to meet the system standard IEC 60601-1-1. Any person who connects additional devices to the signal input or signal output of the PiCCO2 is changing the system configuration and is responsible for observing the requirements of the IEC 60601-1-1 Standard. When high frequency devices are used during surgery, the applying standards for high frequency devices for surgery have to be followed. Check the battery state of charge when using the device. Only when the battery is fully charged a line independant operation for the stated time will be ensured. If the connection to the protective earth conductor cannot be ensured, seperate the device from the mains supply and only use the device on battery power.

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General Information - Blank page -

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Operator’s Manual PiCCO2 Version1.x

Principles of Measurement and Parameters

B

Principles of Measurement and Parameters

1

Introduction The PiCCO2 is a device for continuous cardiac output measurement combined with monitoring of cardiac preload volume, extravascular lung water and central venous oxygen saturation. The PULSION PiCCO2 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. A cold or room-temperate bolus (e.g. normal saline 0.9%) is injected through a central venous catheter. A thermodilution curve is recorded by an arterial thermodilution catheter, which also serves for pressure monitoring. In addition to calibration of the PCCO, transpulmonary thermodilution also yields cardiac preload by means of global end-diastolic volume (GEDV) and an estimation of intrathoracic blood volume (ITBV) and extravascular lung water (EVLW). Furthermore the PiCCO2 continuously measures the central venous oxygen saturation (ScvO2) after calibration with blood gas analysis results and can continuously calculate oxygen delivery (DO2) and oxygen consumption (VO2). To derive its parameters, the PiCCO2 combines the transpulmonary thermodilution technique with continuous arterial pulse contour analysis and fiberoptical measurement of central venous oxygen saturation. If a patient´s weight, height, category and gender are entered, the PiCCO2 presents the derived parameters indexed to the patient´s body characteristics.

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Principles of Measurement and Parameters

2

Transpulmonary Thermodilution Technique

2.1

Priniciple 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. The PiCCO2 detects the cold indicator in the arterial system (preferably in the femoral artery). As a result, a thermodilution curve is recorded.

Figure 1: Heart-lung circulation and resulting thermodilution curve

2.2

Transpulmonary Cardiac Output Cardiac Output (CO) is the volume of blood being pumped by the heart in one minute and it is determined using the Stewart-Hamilton formula (see Appendix). Cardiac output by thermodilution is calculated using the area under the thermodilution curve.

Parameter Cardiac Output, transpulmonary

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Absolute Parameters Abbr. Unit CO l/min

Indexed Parameters Abbr. Unit CI l/min/m2

Operator’s Manual PiCCO2 Version1.x

Principles of Measurement and Parameters

2.3

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. The PiCCO2 uses predicted body weight (PBW) to index intrathoracic volumetric parameters.

Parameter Global End-Diastolic Volume Extravascular Lung Water Global Ejection Fraction Pulmonary Vascular Permeability Index Cardiac Function Index Intrathoracic Blood Volume

Absolute Parameters Abbr. Unit GEDV ml EVLW ml GEF % PVPI CFI 1/min ITBV ml

Indexed Parameters Abbr. Unit GEDI ml/m2 ELWI ml/kg

ITBI

ml/m2

2.3.1 GEDV / ITBV

GEDV

ITBV

Figure 2: GEDV / ITBV Global End-Diastolic Volume (GEDV) is the total amount of blood contained in all four heart chambers, i.e. atria and ventricles, at the end of diastole. Intrathoracic Blood Volume (ITBV) represents the total intravascular amount of blood in the thorax. GEDV and ITBV reflect the circulatory volume status and are excellent indicators of cardiac preload. GEDV and ITBV are used for managing the patient´s vascular filling status and guiding volume therapy.

CAUTION: Aortic aneurysms may cause the displayed blood volume (GEDV/ITBV) derived by thermodiution measurement to be erroneously high.

Operator´s Manual PiCCO2 Version 1.x

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Principles of Measurement and Parameters 2.3.2 GEF / CFI GEF: GEF depends mainly on right and left ventricular contractility and can be used to detect right and/or left ventricular dysfunction. GEF is derived from the ratio of 4 stroke volumes divided by Global End-Diastolic Volume (GEDV).

Figure 3: Global Ejection Fraction (GEF) CFI: CFI represents the ratio between cardiac output and global end-diastolic volume (GEDV). 2.3.3 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.

Figure 4: Extravascular Lung Water (EVLW) 2.3.4 PVPI PVPI shows the relationship between EVLW and PBV (Pulmonary Blood Volume) and can help to distinguish between hydrostatic and permeability caused pulmonary edema.

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Principles of Measurement and Parameters

3

Continuous Pulse Contour Analysis

3.1

Priniciple 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. Transpulmonary thermodilution cardiac output determined simultaneously with continuous arterial pressure measurement is utilized to calibrate the pulse contour analysis to each individual patient´s aortic compliance function.

3.2

Calibration of the Pulse Contour Cardiac Output To calibrate the measurement of continuous cardiac output, a reference thermodilution cardiac output is necessary. The PiCCO2 uses the transpulmonary thermodilution as its reference method.

Figure 5: Calibration of pulse contour analysis by means of thermodilution

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Principles of Measurement and Parameters

3.3

Continuous hemodynamic determination The following parameters are derived by the PULSION PiCCO2 , 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. Absolute Parameters Indexed Parameters Parameter Abbr. Unit Abbr. Unit Pulse Contour Cardiac Output Stroke Volume Systemic Vascular Resistance Stroke Volume Variation Pulse Pressure Variation Cardiac Power Output Heart Rate Mean Arterial blood Pressure Systolic Arterial blood Pressure Diastolic Arterial blood Pressure Central Venous Pressure

PCCO SV SVR SVV PPV CPO HR MAP APsys APdia CVP

l/min ml dyn●s●cm-5 % % W min-1 mmHg mmHg mmHg mmHg

PCCI SVI SVRI

l/min/m2 ml/m2 dyn●s●cm-5●m2

CPI

W/m²

3.3.1 MAP / CVP / HR MAP (Mean Arterial Pressure) Mean arterial pressure is the mean value of the blood pressure in the arterial system measured by an intravascular catheter. CVP (Central Venous Pressure) Central venous pressure is the average blood pressure directly before the right heart. HR (Heart Rate) Heart rate ist the number of heart beats per minute. 3.3.2 PCCO Pulse contour cardiac output is the continuously determined cardiac output from the pulse contour analysis.

CAUTION: As the pulse contour cardiac output of children has not been sufficiently validated thus far, the CO should be checked by thermodilution before therapeutic interventions. Recalibration is recommended with significant changes in hemodynamic conditions, such as volume shifts or changes to medication.

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Operator’s Manual PiCCO2 Version1.x