PULSION PC8500 Operator'S Manual And Product Information Download Page 14

General Information 

 

 

Page A-6 

 

Operator’s Manual PiCCO

2

 

 

 

Version 3.1 

 

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. of 
arterial pressure, defective connections or sensors or by electromagnetic interference (e.g. electric 
blankets, electric coagulation). 

Due to an aortic aneurysm the displayed blood volume (GEDV/ITBV) derived by a thermodilution 
measurement can be erroneously high. 

 

Electrical: 

The PiCCO

2

 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 PiCCO

2

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 PiCCO

2

 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, the 

use of the device can be ensured for the stated time without being connected to the mains. 

If the connection to the protective earth conductor cannot be ensured, separate the device from the mains 
supply and only use the device on battery power. 

 
 

Summary of Contents for PC8500

Page 1: ...ual and Product Information 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 E...

Page 2: ...rder 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...

Page 3: ...B 2 2 1 Principle B 2 2 2 Transpulmonary Cardiac Output B 2 2 3 Transpulmonary volume determination B 3 2 3 1 GEDV ITBV B 3 2 3 2 EVLW B 4 2 3 3 Additional Thermodilution Parameters B 4 3 Continuous P...

Page 4: ...and navigation keys C 5 3 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 Ther...

Page 5: ...dicted body weight C 34 5 2 Monitor settings C 34 5 3 Configuration of parameter display C 35 5 3 1 Setting of alarm limits C 36 5 3 2 PCCI change warning C 36 5 3 3 Parameter settings C 37 5 4 Spider...

Page 6: ...O 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 1 Technical Data E 1 2 Maintenance and Service E 4 2 1 Classification E 4 2 2 Ma...

Page 7: ...ng to Britton Chance University of Pennsylvania B 9 Figure 11 Schematic representation of the ICG elimination curve B 10 Figure 12 Screen elements C 3 Figure 13 Function keys C 4 Figure 14 Patient cab...

Page 8: ...curve C 26 Figure 30 Real time curve of arterial pressure C 28 Figure 31 Parameter fields C 29 Figure 32 Profiles screen C 30 Figure 33 Spider screen C 31 Figure 34 Trend screen C 32 Figure 35 Patient...

Page 9: ...rial haemoglobin SpO2 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 art...

Page 10: ...rison 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 sup...

Page 11: ...ilities pay attention to a 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 sy...

Page 12: ...lary 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 i e catheter tip must not be in the h...

Page 13: ...ctional 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...

Page 14: ...ed 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...

Page 15: ...c preload by means of global end diastolic volume GEDV and an estimation of both intrathoracic blood volume ITBV and extravascular lung water EVLW Furthermore the PiCCO2 continuously measures the cent...

Page 16: ...indicator has passed As a result a thermodilution curve can be recorded The PiCCO2 detects the cold indicator in the arterial system preferably in the femoral artery Figure 1 Heart lung circulation a...

Page 17: ...ar Lung Water EVLW ml ELWI ml kg Global Ejection Fraction GEF Pulmonary Vascular Permeability Index PVPI Cardiac Function Index CFI 1 min Intrathoracic Blood Volume ITBV ml ITBI ml m2 2 3 1 GEDV ITBV...

Page 18: ...avascular Lung Water EVLW 2 3 3 Additional Thermodilution Parameters 2 3 3 1 GEF GEF mainly depends on right and left ventricular contractility and can be used to detect right and or left ventricular...

Page 19: ...sure and blood flow cardiac output simultaneously Transpulmonary thermodilution cardiac output determined simultaneously with continuous arterial pressure measurement is utilized to calibrate the puls...

Page 20: ...an Arterial Blood Pressure MAP mmHg Systolic Arterial Blood Pressure APsys mmHg Diastolic Arterial Blood Pressure APdia mmHg Moreover central venous pressure CVP in mmHg can be measured continuously 3...

Page 21: ...ejection volume responsiveness 3 3 4 SVR SVR represents the resistance the blood encounters as it flows through the vascular system The SVR value is often used by clinicians as an estimate of afterloa...

Page 22: ...amount of haemoglobin bound to oxygen oxygen saturation can be calculated 4 2 Determination of ScvO2 ScvO2 reflects the oxygen saturation of the haemoglobin in the blood in the superior vena cava dire...

Page 23: ...d haemoglobin is included However not included is e g carboxyhaemoglobin or methaemoglobin WARNING External influences carboxyhaemoglobin can result in incorrect high values for SpO2 The degree of ele...

Page 24: ...entation of the ICG elimination curve The figure above shows a typical ICG concentration curve with the initial peak and its course over 500 seconds The elimination measurement starts after thorough m...

Page 25: ...low CI PCCI 3 0 5 0 l min m2 SVI 40 60 ml m2 Preload Volume GEDI 680 800 ml m2 ITBI 850 1000 ml m2 SVV 10 PPV 10 Afterload SVRI 1700 2400 dyn s cm 5 m2 Contractility GEF 25 35 CFI 4 5 6 5 1 min dPmx m...

Page 26: ...ning 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 conditio...

Page 27: ...h hazards 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...

Page 28: ...Installation and setup Page C 2 Operator s Manual PiCCO2 Version 3 1 Blank page...

Page 29: ...selected parameters 4 Patient screen Function area for measurements configuration and graphical display of parameters 5 Display options The determined parameters can be displayed in 3 different ways...

Page 30: ...3 Function keys ON OFF key This key is used to switch the device on and off As soon as the mains power switch is pressed at the rear side of the device a green light appears The green light indicates...

Page 31: ...ys 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 po...

Page 32: ...les socket with equipment class defibrillator protection NOTE PiCCO2 is protected against electric shock in case of defibrillation WARNING Do not use damaged probes or patient cables Do not use any pr...

Page 33: ...rk 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 conn...

Page 34: ...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...

Page 35: ...fer to chapter 3 2 3 Do not measure the central venous pressure CVP through the sensor housing and or do not apply glucose or lipid containing substances by the sensor housing Before installation air...

Page 36: ...ent to the LiMON module 3 2 3 Application of injectate temperature sensor housing and CeVOX probe at the same time As the CeVOX probe is placed through the distal lumen of the central venous catheter...

Page 37: ...ension lines without protective earth conductor CAUTION If the connection to the protective earth conductor cannot be ensured disconnect the device from the mains supply and only use the device on bat...

Page 38: ...easurement results will be stored by the monitor PCCO calibration can be restored up to 15 minutes after the last shutdown of the device ScvO2 calibration can be restored up to 24 hours after the last...

Page 39: ...rsion 3 1 C 13 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 cathe...

Page 40: ...t category and gender is mandatory for the accuracy of the displayed parameters as well as for the correct indexing of some parameters Patient name and ID can be entered optionally WARNING If a new pa...

Page 41: ...nsducer by the pressure line x Adjust curve scaling with the respective buttons x If necessary repeat this procedure for the central venous pressure x In cases where continuous central venous pressure...

Page 42: ...al quality may be compromised by the following x Strong pulsation motion artifacts x Signal intensity e g kinking of probe blood clot or haemodilution x Intermittent wall contact by the tip of the pro...

Page 43: ...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 4 Slowly withdraw 2 ml blood from the sid...

Page 44: ...l other monitor functions can be operated When returning to the ScvO2 screen the lab values for the respective measurement can be entered In cases where the lab results are invalid press Reject button...

Page 45: ...try For detailed information please refer to chapter B5 1 Principle of pulse oximetry NOTE The non invasive ICG measurement is not recommended for use on patients weighing less than 20 kg 44lbs Manual...

Page 46: ...This is indicated by blinking asterisk symbols As the SpO2 value may still be affected by ICG after the measurement the device will display corrected values This is indicated by a question mark next t...

Page 47: ...e and results Single PDR results are displayed in a table Current values are displayed in white on the right side of the table These values are also displayed in the parameter field The last 6 measure...

Page 48: ...Figure 24 The necessary ICG quantity and injectate volume will be calculated according to the data input Weight kg Actual body weight of patient used for the calculation ICG Dose 0 25mg kg 0 5mg kg S...

Page 49: ...termine the patient s volume status and to calibrate the pulse contour analysis with reference to the CO value Three to five single thermodilution measurements within 10 minutes are recommended With a...

Page 50: ...and if necessary flush the PiCCO catheter If necessary perform a zero adjustment Manually input central venous pressure CVP if not using continuous CVP measurement 3 Prepare appropriate injectate sol...

Page 51: ...tion measurement in order to calibrate the pulse contour analysis Body weight kg Cold 8 C Room temperature 24 C 3 2 ml 3 ml 10 3 ml 5 ml 25 5 ml 10 ml 50 10 ml 15 ml 100 15 ml 20 ml t 100 20 ml 20 ml...

Page 52: ...tion curve x A normal curve has one smooth peak and then returns in direction to the baseline x The maximum temperature difference T should exceed 0 10 C x The used injectate volume Vinj the measured...

Page 53: ...ctive graphic element WARNING The device enables the monitoring of physiological parameters The clinical significance of changes in the monitored parameters must be determined by physician 4 1 Informa...

Page 54: ...ome of these bars are missing the PiCCO2 cannot analyze the blood pressure curve and thus cannot display results for the continuous CO Selection of the curve on the touch screen directly leads to zero...

Page 55: ...e 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 th...

Page 56: ...lue range which is highlighted NOTE All values displayed in the profile correspond to the time of the last thermodilution measurement The option Overview shows the main parameters The organ specific p...

Page 57: ...diagram is displayed GREEN as long as all displayed parameters are within the normal or target value range The diagram is displayed YELLOW immediately one of the displayed parameters goes outside the...

Page 58: ...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 The ver...

Page 59: ...n the device automatically displays this option NOTE Correct input of height weight category and gender is mandatory for the correct indexing of some parameters Selection of height weight display in t...

Page 60: ...are needed for the calculation of the Body Surface Area BSA Predicted Body Weight PBW and Predicted Body Surface Area PBSA These calculated body characteristics are required for the indexing of PiCCO2...

Page 61: ...ter field on the right side of the screen directly leads to the configuration screen The parameter display can be configured individually The main parameters are always displayed and cannot be deselec...

Page 62: ...ed since the last measurement and the change percentage e g PCCI xx for positive values or PCCI xx for negative values are alternately displayed in the right part of the information bar for further in...

Page 63: ...s Display of units Yes No The respective parameter units can be activated or deactivated with this option Parameter selection Basic Cardiac Septic Individual The main parameters are shown in the basic...

Page 64: ...r of spider legs 3 to 7 x Select the parameter to be placed left x Select the spider leg where the parameter should be placed The spider configuration can be opened by direct selection of the spider d...

Page 65: ...y direct selection of the trend diagram L New in version 3 1 The buttons SVV and PPV are both available for selection L Depending on the selection in the Parameters configuration tab either the GEF or...

Page 66: ...emoralis A Radialis The intended catheter position is displayed and can be changed if necessary Auto Thermodilution Mode Auto TD Off 3x 4x 5x The number of TD measurements can be set automatically The...

Page 67: ...ll be displayed depending on body weight of the patient see also Figure 40 Measurement configuration screen Default setting for an adult patient is 15ml 5 6 3 Configuration of ScvO2 measurement Hb Hct...

Page 68: ...s applies for all display screens Spider Trends and Profile In the SpiderVision diagram the target value symbol is displayed next to the respective parameter if the target value is activated In order...

Page 69: ...peaker symbol directly leads to setting of the alarm volume The volume and the status of the acoustic alarm are displayed on the right side of the information bar Alarm muted 2 min 5 min Blinking Alar...

Page 70: ...necessary Internal error SERVICE necessary 6 2 Error Messages Text error messages are displayed in the information bar chapter C4 1 When viewing old measurements the respective error messages are disp...

Page 71: ...lder injectate 24 C T small Use more and or colder injectate T 0 1 C Use more and or colder injectate Invalid PCCO Calibration Check AP signal and repeat injection Implausible arterial pressure signal...

Page 72: ...ient for more than 5 seconds Check connection of the sensor Pulse not detected Relocate LiMON sensor Insufficient pulse signal for more than 5 seconds Reposition the sensor to a place with better perf...

Page 73: ...quest another action during thermodilution Measurement is rejected Not included in average Reject a TD measurement Measurement included in average Selection of an active TD measurement TD Measurement...

Page 74: ...s during zero adjustment Zero adjustment of AP successful Pressing AP 0 button Zero adjustment of CVP successful Pressing CVP 0 button Zero adjustment of PAP successful Pressing PAP 0 button Zero adju...

Page 75: ...software or hardware version can be obtained Components x Setup Setup Guide PiCCO2 see Figure 16 x Normal Values Target Values This tab details the normal value ranges target value ranges of the indi...

Page 76: ...selected in the trend configuration screen x Thermodilution When pressing the Print key while the thermodilution screen is displayed the printout includes a table with the results of the last thermod...

Page 77: ...ining capacity in 25 steps Battery powered 25 capacity Red blinking with acoustic alarm No battery in device Grey crossed out symbol In cases of a battery alarm the acoustic alarm can be paused for 5...

Page 78: ...upplies x Always dilute the used substances according to the manufacturer s instructions or use the lowest possible concentration x Take care that no liquid enters the PiCCO2 case x Do not allow clean...

Page 79: ...h cleaning methods than the housing x Do not allow water or cleaning solution to enter the connectors of the monitor Recommended cleaning agents x Tensides Edisonite Schnellreiniger x Ammonias Dilutio...

Page 80: ...Installation and setup Page C 54 Operator s Manual PiCCO2 Version 3 1 Blank page...

Page 81: ...a usable length of 7 cm and a distal lumen 20 22 G cannula guide wire PV2014L08 A PV2014L08N PV2014L08 4F thermodilution catheter with a usable length of 8 cm and a distal lumen 20 G cannula J guide w...

Page 82: ...ring kits for arterial pressure contain x pressure transducer with macro set spike line lock and flush device flow rate 3 ml h x 3 way stopcock injectate temperature sensor housing PV4046 x 150 cm red...

Page 83: ...cm PV2022 32 2F CeVOX probe usable length 32 cm PV2022 33 2F CeVOX probe usable length 33 cm PV2022 35 2F CeVOX probe usable length 35 cm PV2022 37 2F CeVOX probe usable length 37 cm PV2022 38 2F CeVO...

Page 84: ...ule PC51100 LiMON Reusable Sensor large PC51200 LiMON Reusable Sensor medium PC51300 LiMON Reusable Sensor small PC85300 PiCCO2 Thermotransfer printer PC85350 Printer labels 565 labels per roll PC8535...

Page 85: ...able Art No PC80150 Injectate temperature sensor cable Art No PC80109 Pressure cable Art No PMK 206 PiCCO2 AUX Adapter Art No PC85200 Mains power cable Art No 40109X dependent on country Grounding cab...

Page 86: ...ndensing Ambient Pressure Storage 700 hPa to 1060 hPa Ambient Pressure Transport 270 hPa to 1060 hPa Physical Attributes Size W x H x D 328 mm x 248 mm x 180 mm with navigation dial Weight 5 kg Standa...

Page 87: ...iation 3 EVLW ml 10 5000 Coefficient of variation 6 ScvO2 1 99 3 for 50 80 SpO2 45 100 70 SpO2 100 2 SpO2 70 not validated PDR min 0 0 50 0 3 min absolute or 15 relative R15 0 0 99 9 n a TB C 25 45 0...

Page 88: ...UTION 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...

Page 89: ...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 PiCCO2 is subj...

Page 90: ...mation 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 CAUTION Furthermore all configurations...

Page 91: ...t Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The PiCCO2 uses RF energy only for its internal function Therefore its RF emissions are very low and are...

Page 92: ...l commercial or hospital environment Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical commercia...

Page 93: ...and d is the recommended separation distance in meters m Field strength from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each f...

Page 94: ...MHz to 2 5 GHz d 2 33m V P 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 70 3 70 7 37 100 11 70 11 70 23 3 For transmitters rated at a maximum output power not listed above the recomme...

Page 95: ...0 3964 x 0 024265 Haycock BW 15kg BSA BW 0 425 x height 0 725 x 0 007184 DuBois BW 15kg PBW Predicted Body Weight kg Calculated according to height gender and category PBSA Predicted Body Surface Are...

Page 96: ...ape of pressure curve PCCI PCCO BSA where PCCI Pulse Contour Cardiac Output Index l min m2 PCCO Pulse Contour Cardiac Output l min BSA Body Surface Area m2 SV PCCO HR x 1000 where SV Stroke Volume ml...

Page 97: ...m2 5 3 Preload Volume GEDV CO x 1000 x MTtTDa DStTDa 60 GEDV ITTV PTV where GEDV Global End Diastolic Volume ml ITTV Intrathoracic Thermal Volume ml where ITTV CO x 1000 x MTtTDa PTV Pulmonary Therma...

Page 98: ...PPV Pulse Pressure Variation PP Pulse Pressure APsys APdia APsys Systolic Arterial Pressure APdia Diastolic Arterial Pressure PPmax Mean value of 4 maximum Pulse Pressures of the last 30 seconds mmHg...

Page 99: ...al Volume ml ITBV Intrathoracic Blood Volume ml ELWI EVLW PBW where ELWI Extravascular Lung Water Index ml kg EVLW Extravascular Lung Water ml PBW Predicted Body Weight kg CPO PCCO x MAP x 0 0022 wher...

Page 100: ...ncentration of deoxygenated haemoglobin g dl DO2 1 34 x Hb x SaO2 x PCCO x 10 where DO2 Oxygen delivery ml min Hb Concentration of haemoglobin g dl SaO2 Arterial Oxygen Saturation PCCO Continuous Puls...

Page 101: ...n of haemoglobin g dl SaO2 Arterial Oxygen Saturation ScvO2 Central Venous Oxygen Saturation PCCI Pulse Contour Cardiac Output Index l min m2 SpO2 HbO2 HbO2 HbDes where SpO2 Partial arterial oxygen sa...

Page 102: ...Appendix Page E 18 Operator s Manual PiCCO2 Version 3 1 6 Flow chart...

Page 103: ...protected against defibrillation Equipment Type CF protected against defibrillation Symbol for battery status Time indicator for parameters which are not continuously derived Loudspeaker Separate dis...

Page 104: ...ts such as re sale or suitability of the PiCCO2 for a particular purpose Disposables and accessories which are used with the PiCCO2 are not covered by this guarantee PULSION offers no guarantee for th...

Page 105: ...ential burns ATTENTION Consult accompanying operator s manual 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 place other e...

Reviews: