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Appendix

Operator´s Manual PiCCO

Page

Version 3.1

E-21

For technical assistance or customer order entry, contact:

PULSION Medical Systems SE
Hans-Riedl-Str. 17
D-85622 Feldkirchen
Phone:

+49 - (0)89 - 45 99 14

–

Fax:

+49 - (0)89 - 45 99 14

–

E-mail:

[email protected]

Internet:

www.PULSION.com

WARNING:

Explosion hazard when used in the presence of flammable anesthetics.

Do not use the device while a MRI scan is being carried out. Induced voltage can result in potential
burns.

ATTENTION:

Consult accompanying operator’s manual.

Do not expose the PiCCO

to temperatures above 40 °C or below 10 °C. The accuracy of the measured

values may be affected.
Do not place other equipment or containers with liquid on top of the PiCCO

Patents:

EP1598005, EP0947941, US6315735, JP3397716, US6200301, EP0637932, US5526817, JP3242655, EP1034737,
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.

Содержание PC8500

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

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