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Task Force Monitor Operators Manual V2.3 Sept 2015
Operators Manual
103 Pages
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Task Force® Monitor – Operator’s Manual V2.3
The Task Force® Monitor meets the requirements of
- mark
according to the European standard for medical devices 93/42/EWG and meets the fundamental requirements of annex I of this standard. The Task Force® Monitor meets the standard "IEC Electromagnetic compatibility - Requirements and tests".
60601-1-2,
2.
Collateral
Standard:
This handbook refers to the following configuration: Hardware: Task Force® Monitor 3040i and Task Force® Monitor 3030i (no impedance cardiography measurement available) Software: Version 2.3
CNSystems Medizintechnik AG Reininghausstrasse 13 A - 8020 Graz Austria T: (+43) 316 7 23456-0 F: (+43) 316 7 23456-2 E: office@cnsystems.at W: www.cnsystems.at
Edition: 30 September 2015
Table of Contents
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Table of Contents 1.
General information ... 1-1 1.1 Warnings ... 1-1 1.2 Precautions ... 1-2 1.2.1 General ... 1-2 1.2.2 ECG and ICG ... 1-3 1.2.3 Oscillometric and continuous blood pressure ... 1-3 1.3 Setup precautions and the usage of a medical electric system ... 1-4 1.4 Electromagnetic compatibility... 1-6 1.5 Disposal ... 1-9 2. Use and function ... 2-1 2.1 Basics ... 2-1 2.2 Haemodynamic parameters ... 2-2 2.3 Assembly of the Task Force® Monitor ... 2-5 2.3.1 Front view of the Task Force® Monitor ... 2-5 2.3.2 Rear view of the Task Force® Monitor ... 2-6 2.3.3 Connecting the Task Force® Monitor to the PC ... 2-6 2.3.4 Explanation of the symbols ... 2-8 2.4 Standards ... 2-9 2.5 Starting up the Task Force® Monitor ... 2-10 2.6 Thesycon IEEE 1394 driver installation ... 2-11 3. Equipping the patient ... 3-1 3.1 Donning of the ECG electrodes ... 3-1 3.2 Donning of the ICG electrodes... 3-2 3.3 Donning of the continuous blood pressure device ... 3-4 3.4 Donning of the oscillometric blood pressure cuff ... 3-5 4. Cleaning, disinfection and inspection ... 4-1 4.1 Surfaces of the device ... 4-1 4.2 Patient cables and electrodes ... 4-1 4.3 Arm cuffs ... 4-2 4.4 Recurrent inspection and safety inspection ... 4-2 4.5 Warranty ... 4-2 5. Technical description ... 5-1 5.1 General description ... 5-1 5.2 Power supply unit ... 5-1 5.3 Vascular unloading monitor (continuous blood pressure device) ... 5-2 5.4 ECG (Electro Cardiography) ... 5-2 5.5 ICG (Impedance Cardiography) ... 5-3 5.6 Oscillometric blood pressure ... 5-3 5.7 External input ... 5-4 6. Accessories ... 6-1 7. The Task Force® Monitor program ... 7-1 7.1 Starting up the PC and the Task Force® Monitor program ... 7-1 7.1.1 Licensing of the version ... 7-1 7.2 Starting up the Task Force® Monitor program ... 7-2 7.2.1 Tool bar ... 7-3 7.3 New measuring ... 7-4 7.3.1 Typical duration of a measurement ... 7-4 7.3.2 Starting a new measurement ... 7-4 7.3.3 View options ... 7-8 7.3.4 Additional icons during the measurement... 7-13 7.3.5 Interventions and comments ... 7-16 7.3.6 The measuring marker (Calliper) ... 7-17 7.3.7 Calliper statistic ... 7-21 7.3.8 Tooltip ... 7-21 7.3.9 Pause ... 7-23 7.3.10 Keyboard assignment and help function ... 7-25 7.4 Open and save a measurement - navigation through the measurement ... 7-27 7.4.1 Saving a measurement ... 7-27 7.4.2 Open a saved measurement ... 7-28 7.4.3 Navigation through the measurement... 7-30 7.5 Graphic view ... 7-31 7.6 Data views ... 7-32 Task Force® Monitor – Operator’s Manual
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7.7 Printing a measurement file ... 7-32 7.7.1 Printing, print reports and print objects ... 7-33 7.8 Export of the Task Force® Monitor measuring data ... 7-36 7.9 Diagnosis editor ... 7-36 7.9.1 Import of RTF-templates for the diagnosis editor ... 7-38 7.10 Warning messages of the Task Force® Monitor program ... 7-40 7.10.1 General messages concerning the system ... 7-40 7.10.2 Messages concerning the oscillometric blood pressure device ... 7-43 7.10.3 Messages concerning the continuous blood pressure device ... 7-45 7.11 How to use the Help ... 7-46 8. Declaration of conformity ... 8-1 9. Literature ... 9-1 10. Glossary... 10-1 11. Index... 11-1
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1. General information 1.1 Warnings • • •
• • • • •
• •
• • • • • • •
®
The Task Force Monitor is a diagnosis supporting device! The medically trained user must permanently be present during measurement. ® The Task Force Monitor reports no alarms and is therefore not designed for stand-alone long-term monitoring of patients. ® Do not deduce any direct diagnoses from any signals or data of the Task Force Monitor. The ® Task Force Monitor is a diagnosis supporting device and therefore not designed for vital sign monitoring. ® The Task Force Monitor is not for intracardial use. Do never connect the device’s pneumatic connectors to an intravascular system! Do not use the oscillometric cuff on limbs with vascular prostheses! ® Please keep children away from the Task Force Monitor. The device is not designed to be used in explosive surroundings that can arise from the usage of flammable anaesthetics, skin detergents and skin disinfectants. Also do not use the device in combustible atmosphere (if air contains more than 25% of oxygen or nitrous oxide gas)! The distance between patient and PC during measuring must be minimum 1.5 m (5 feet). The user has to ensure that prolonged impairments of the patient’s blood circulation during measuring are prevented by inspecting the concerned limbs. This especially applies to the continuous blood pressure measurement. During normal use, the pressure in the finger cuff will be the same as the artery and therefore greater then normal venous pressure. As a result, depending on the temperature of the skin, thickness, patient's age, perfusion, and presenting state, venous congestion of the finger distal to the cuff may be observed and will subside with the discontinuation of monitoring. Check monitoring site frequently though and discontinue the continuous blood pressure measurements immediately with any signs of total arterial compression or if patient reports severe pain or discomfort. Do not use the compressed air supply valves with any devices of a third party manufacturer. Do not place electrodes (electrode set PN 01616), arm fixations, upper arm cuffs and finger cuffs on injured or sore skin. ® If the buzzer of the Task Force Monitor main monitor reports an alarm, immediately detach all compressed air hoses and cables. One device is designed for the concurrent measurement of only one patient/proband. Never measure two or more patients at the same time applying only one device! The accumulation of leakage currents due to the connection of more than one device to the patient can occur and can be of possible danger for the proband. The single device components must only be used in connection with the original system. Please mind the notes regarding the electromagnetic compatibility in chapter 1.4.
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General information
1.2 Precautions 1.2.1
General
•
The Task Force
®
Monitor is a device of protection class I. The input ports of ECG and ICG are
of type CF and protected from defibrillation. Both the device as well as the patient are at no risk during defibrillation and HF-surgery. However, be careful when using the device simultaneously with a defibrillator or any other device connected to the patient. Please care to always keep a minimum distance of 15 cm (6 inches) between the ECG and ICG electrodes or ® temporarily disconnect the cables from the Task Force Monitor. • •
• • • • • •
• • • •
•
•
The patient inputs of type BF (external inputs, continuous blood pressure device) are not protected from defibrillation impulses! As a principle be careful when using medical devices. Especially, make sure that all conductive ® parts connected with the isolated patient input ports of the Task Force Monitor, for example patient, plugs, electrodes or sensors, do not touch any other earthed and conductive parts. This would bridge the patient’s isolation. In particular, a contact between the neutral electrode and the earth potential has to be avoided. The patient is not supposed to speak during a measurement. We recommend a quiet, darkened room for your measurements. The “Fire Wire” cable must not be longer than 3 meters (10 feet). ® The Task Force Monitor meets the requirements of the EN 60601-1-1 and can be used next to patients without restrictions. Using two or more devices with ICG function in one patient can cause interactions. Please contact the manufacturer of third party devices or CNSystems Medizintechnik Austria. ® No liquids must ingress the device. In case a liquid should enter the Task Force Monitor only start it up again after the inspection by a technician. Any chemicals needed for the use and maintenance of the device are to be prepared and stored in correspondingly designated containers to prevent confusions leading to severe consequences. ® Medical devices like the Task Force Monitor are to be operated by accordingly trained persons only who can guarantee a proper handling of the device due to their special education. ® The user has to be familiar with operating the Task Force Monitor. Every time before measuring the user also has to check if the device is in duly condition and operates safely. Before connecting the cables to the patient, the patient cables have to be optically inspected. Replace any faulty parts. Only original CNSystems Medizintechnik AG parts shall be used. Also mind the storage of the device: do not deviate wires and hoses or coil them up in a too small radius which might result in damaged cables and hoses. Damaged or faulty cables and hoses have to be replaced immediately. Apply original CNSystems Medizintechnik AG patient cables only! For additional devices that are connected to the external input find the tolerable signal threshold values in chapter 5 of this manual. ® Before connecting an accessory device to the Task Force Monitor please contact the manufacturer CNSystems Medizintechnik AG. Only devices inspected and released by CNSystems Medizintechnik AG shall be connected.
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1.2.2 • •
• •
•
•
• • •
1.2.3 • • •
•
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ECG and ICG Disinfect the respective skin areas before placing the electrodes and make sure that the skin is absolutely dry before affixing the electrodes. The electrode package should not be opened until immediately prior to use. Before opening the electrode package please check the expiry date on the package. Expired electrodes must not be used. Persons allergic to polyacrylate may have slight skin injuries when removing the electrodes. Please pay attention to the correct positioning of the blue clips of the ICG cable. By positioning them incorrectly neither patient nor user are at risk. The quality of the measurement signals however will be impaired. If the neutral electrode is not donned to the patient’s leg, the measuring signals of ECG and ICG could have interferences and the measurement is unusable. In that case don the neutral electrode to a leg of the patient and restart the measurement. If the ECG signal is interfered by strong noises, the RR-detection could be faulty. This can also have an influence on the blood pressure detection and the stroke volume detection. Disinfect the respective skin parts and use new electrodes. The quality of the ICG measuring signal could decrease after a longer measurement due to transpiration of the patient. Disinfect the respective skin parts and use new electrodes. Do not touch the patient during measurement; this could result in a noisy ICG signal. The accuracy of the ICG signal can decrease under the following conditions: * sepsis * aortic valve insufficiency * aortic valve stenosis * patient movement artifacts
Oscillometric and continuous blood pressure ®
Avoid compressing the air-hoses or reducing their cross-section when using the Task Force Monitor and do not bend the cables. This could impair the quality of the measuring signals. Protect unused jacks with the enclosed dust cabs to prevent dirt from entering. In rare cases the device cannot detect the continuous blood pressure. Usually the middle finger is the best option because its joints are longer than those of the index finger. Nevertheless, try a change of fingers if you do not receive a signal from the middle finger. When receiving a signal from the index finger is still impossible, this is, in most cases, caused by a Vasospasm. Warming the hand, for example in warm water, can help. If the continuous blood pressure curve is not displayed after a few minutes, the blood flow in the finger is insufficient. You could change the finger or possibly the hand. If this step is not successful, please check if the label (figure and size) on the “Flying-V” continuous blood pressure cuff is on the back of the hand and whether the compressed air hoses are connected ® correctly to the Task Force Vascular Unloading Device (black marked hose with black marked jack). If the blood flow is strongly insufficient, you have to abandon the continuous blood pressure measurement completely. To avoid mechanical damage to the finger cuff, never measure without a finger in the blood pressure cuff. Remove all objects (e.g. rings) from the fingers before measuring. The accuracy of the oscillometric blood pressure signal can decrease (up to loss of the measurement) under the following conditions: * weak pulses * irregular pulses * patient movement artifacts * tremor artifacts * respiratory artifacts
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1.3 Setup precautions and the usage of a medical electric system A medical electric system is defined as the combination of several devices of which at least one is a medical electric device and which are either functionally linked or connected through a portable multiple socket. ® The Task Force Monitor system complies with this definition by being the combination of the medical main unit connected with non-medical electric devices such as PC, screen and printer. As there might be danger for the patient caused by the accumulation of leakage currents when several ® devices are connected, there are two possibilities for the user to operate the Task Force Monitor System: 1. Supply of the single devices by detached power grids ®
The Task Force Monitor (main unit) and its additional devices (PC, screen and printer simultaneously) are operated through separated power supply systems. Please mind placing the non-medical electric devices out of the patient environment during measurement. In this case CNSystems Medizintechnik AG recommends a technical measurement check of the permissible leakage currents according to EN 60601-1-1:2001 before starting the system.
Patient environment 2. Supply of the single devices by an isolation transformer licensed according to the Medical Device Directives (EN 60601-1-1:2001). ®
In this case all appendant devices of the system (Task Force Monitor main unit, PC, screen and printer) are supplied by a galvanically isolated transformer. The system can be risklessly operated within the patient’s environment. All non-medical electrical devices must comply with their affective IEC- or ISO standard. Please mind for both cases:
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• • • • • • • •
Page 1-5
Do not connect any other devices than the ones delivered to the multiple socket provided by CNSystems (e.g. to trolley). Additional portable multiple sockets or extension cables must not be used! Portable multiple sockets must not be placed on the floor! ® Before connecting the Task Force Monitor to the power supply system make sure that the voltage indicated on the type plate attached to the backside of the device corresponds with the mains voltage. The electric installation must comply with the national standards for medically used rooms (for Austria e.g. ÖVE EN1, ÖVE E8001, ÖVE EN7). In particular, the power supply system must be secured with a 30 mA earth leakage circuit breaker and a functioning ground wire. ® Before putting the Task Force Monitor into operation check the cables for any damages. In case of damage, cables and plugs must be replaces immediately. ® To disconnect the Task Force Monitor from the power supply system remove the mains plug from the socket first, then disconnect the mains cable from the device. Devices may only be interlinked or connected to parts of other rigs if the patient’s, user’s or other person’s safety is secured. If safety may not be ensured by an interconnection, the user has to make sure of the unobjectionable use by inquiring the manufacturer or a skilled person. In any case the EN 60601-1-1:2001 standard has to be observed. CNSystems Medizintechnik AG recommends the usage of a medical certified isolating transformer for the supply of the medical electrical system.
Additional precautions: • • • • • • •
•
• • • • •
The user must not de-install or replace software components nor install new software on the ® PC. Excepted are original updates of the Task Force Monitor software. The device has to be provided with regular air circulation. Please refer to the specified environmental conditions in the technical description (chapter 5) of the operator’s manual. Check regularly if the device operates properly (app. every month). ® This manual forms part of the Task Force Monitor. By adhering to it the correct use as well as the patient’s and user’s safety is ensured. Notes of particular importance are explicitly marked with CNSystems Medizintechnik AG does not provide guarantees for any damages when parts of third party manufacturers are used. Use original CNSystems accessories and replacement parts only in order to ensure faultless functioning of the system as well as the patient’s safety, accuracy of measurements and immunity. The admitted replacement parts and accessories are listed in chapter 6 of this operator’s manual. CNSystems does not warrant for faultless functioning and operation using third party manufacturer replacement parts and accessories. CNSystems warrants faultless functioning, safety and reliability on condition that installation, extensions, new settings, alterations, maintenance and repair are exclusively carried through by CNSystems or an authorized company. The Task Force® Monitor must be applied in accordance with the instructions in this operator’s manual. All copyrights concerning the devices, procedures, electronic circuits, software and labels mentioned in this manual are reserved to CNSystems Medizintechnik AG. WINDOWS 7 is a trade mark of Microsoft Inc. Backup your measuring data and defragment the hard drive of the computer regularly. ® While the Task Force Monitor program is activated please do not have any other programs running or started. Screen savers must not be activated in WINDOWS. The basic settings of the screen (1280 x 1024 pixels for PC and 1366 x 768 for notebooks) should not be modified in any way.
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1.4 Electromagnetic compatibility Medical electric devices are subject to special safety measures regarding EMC (Electromagnetic compatibility). Please read the respective precautions in this operator’s manual carefully before installing and operating the Task Force® Monitor. Furthermore, mind that portable and mobile HF-communication equipment (e.g. mobile phones) can influence medical electric devices. The Task Force® Monitor must not be placed side by side or in tiers with other devices. If it is absolutely necessary to operate the Task Force® Monitor near or in tiers with other devices, the TFM must be observed to verify normal operation within this arrangement of devices. Use original CNSystems accessories and cords only! The admitted replacement parts and accessories are listed in chapter 6 of this operator’s manual. Using third party manufacturer accessories may result in increased emission or in decreased immunity of the device. Electric and magnetic fields can influence the proper functioning of the device. Please avoid using the Task Force® Monitor close to devices emitting large electromagnetic fields such as, for example, x-ray equipment, diathermy apparatus or magnetic resonance tomographs. Guidance and manufacturer’s declaration – electromagnetic emissions The Task Force® Monitor 3040i is intended for use in the electromagnetic environment as specified below. The customer or the user of the Task Force® Monitor 3040i is supposed to assure it is used in such an environment. Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions CISPR 11
Group 1
The Task Force® Monitor 3040i uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11
ClassB
Harmonic emissions IEC 61000-3-2
NA
The Task Force® Monitor 3040i is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Voltage fluctuations/ emissions IEC 61000-3-3
flicker
NA
Table 201 from IEC 60601-1-2:2003
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Guidance and manufacturer’s declaration – electromagnetic immunity The Task Force® Monitor 3040i is intended for use in the electromagnetic environment specified below. The customer or the user of the Task Force® Monitor 3040i should assure that it is used in such an environment. Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment- guidance
Electrostatic discharge (ESD) IEC 61000-4-2
± 6 kV contact ± 8 kV air
± 6 kV contact ± 8 kV air
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Electrical fast transient /burst IEC 61000-4-4
± 2 kV for power supply lines ± 1 kV for input/output lines
± 2 kV for power supply lines*
Mains power supply quality should be that of a typical commercial or hospital environment.
Surge IEC 61000-4-5
± 1 kV differential mode ± 2 kV common mode
± 1 kV differential mode ± 2 kV common mode
Mains power supply quality should be that of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11
< 5 % UT (> 95 % dip in UT)
< 5 % UT (> 95 % dip in UT)
for 0,5 cycle 40 % UT (60 % dip in UT)
for 0,5 cycle 40 % UT (60 % dip in UT)
for 5 cycles 70 % UT (30 % dip in UT)
for 5 cycles 70 % UT (30 % dip in UT)
for 25 cycles < 5 % UT (> 95 % dip in UT) for 5 sec
for 25 cycles < 5 % UT (> 95 % dip in UT) for 5 sec
Mains power quality should be that of a typical commercial or hospital environment. If the user of the Task Force® Monitor 3040i requires continued operation during power mains interruptions, it is recommended that the Task Force® Monitor 3040i be powered from an uninterruptible power supply or a battery.
3 A/m
3 A/m
Power frequency (50 Hz/60 Hz) magnetic field IEC 61000-4-8
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Note: UT is the a.c. mains voltage prior to application of the test level.
Table 202 from IEC 60601-1-2:2003 * Note: Electrical fast transients/bursts are displayed in the Task Force® Monitor 3040i software in the signal views. This action is tolerable according to IEC 60601-1-2:2003, because these disturbances can be explicitly differentiated from the physiological signals and are furthermore not included in the analysis of the physiological signals. This ensures that the diagnosis or the treatment through the medical user is not affected at all.
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Guidance and manufacturer’s declaration – electromagnetic immunity The Task Force® Monitor 3040i is intended for use in the electromagnetic environment specified below. The customer or the user of the Task Force® Monitor 3040i should assure that it is used in such an environment Immunity test IEC Compliance level** Electromagnetic environment 60601guidance test level Portable and mobile RF communications equipment should be used no closer to any part of the Task Force® Monitor 3040i, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3
3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2,5 GHz
1 Vrms
1 V/m for 80 MHz to 800 MHz
for 800 MHz to 2,5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:
Note 1:
At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2:
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Task Force® Monitor 3040i is used exceeds the applicable RF compliance level above, the Task Force® Monitor 3040i should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Task Force® Monitor 3040i. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 1 V/m.
a
b
Table 204 from IEC 60601-1-2:2003 ** Reasons for the lower compliance level: That the compliance levels are lower in comparison to the immunity level of the EMC-basic standards ® is thus acceptable because the physiological signals measured by the Task Force Monitor 3040i are much lower than the required disturbances.
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Recommended separation distance between portable and mobile RF-communication ® equipment and the Task Force Monitor 3040i. The Task Force® Monitor 3040i is intended for use in an electromagnetic environment with controlled RFdisturbances. The customer or the user of the Task Force® Monitor 3040i can avoid electromagnetic disturbances by complying with the minimum distance between portable or mobile RF-communication equipment (transmitter) and the Task Force® Monitor 3040i – depending on the power output of the communication equipment as specified below. Rated power output of the transmitter W
0,01 0,1 1 10 100
Separation distance depending on the transmit-frequency m 150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2,5 GHz
0,35 0,11 3,50 11,07 35,00
0,35 0,11 3,50 11,07 35,00
0,7 2,21 7,00 22,14 70,00
The maximum rated power output values of transmitters that are not listed in the above list can be calculated by means of the equation noted in the respective column, whereas the maximum rated power output is P in watts (W) according to the specification of the manufacturer.
Note 1:
At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2:
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
Table 206 from IEC 60601-1-2:2003
1.5 Disposal Packing: ® • Please dispose of the packing of the Task Force Monitor according to the national regulations. ECG- and ICG electrodes: • The ICG electrodes can be disposed without environmental impact. The materials used are not toxic and can be deposed or even combusted appropriately without causing resultant toxic waste or polluting emissions. The materials used such as polyethylene, polyester or polyole combust without residues. The aluminium of the electrodes and of the wrapping as well as the PP-foil is not combustible and slag. The electrolytes also slag. Device and accessories: • Dispose the packing accordingly. ® • Dispose the Task Force Monitor and its accessories (patient cables, cuffs) at the end of the product’s lifecycle according to the national regulations or send the parts back to CNSystems Medizintechnik AG. • The ECG- and ICG electrodes are single use electrodes. Please dispose them according to your national regulations.
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2. Use and function This chapter contains basic information about the functions and the starting up of the Task Force Monitor.
®
2.1 Basics ®
The Task Force Monitor is destined for use in hospitals, clinical institutions, medical practices and for ambulant patients. The proper use of the device is defined for non-invasive measurements of a patient’s hemodynamic parameters applying Impedance Cardiography (ICG), Electrocardiography (ECG), oscillometric (oscBP) and continuous (contBP) blood pressure measurement. All signals are derived non-invasively. Six electrodes are placed on the thorax of the patient, one in the neck and one on the leg. Further, one cuff for the oscillometric blood pressure measurement is placed on the upper arm of the patient and one cuff for the continuous blood pressure is placed on the fingers. ® The Task Force Monitor records the patient’s hemodynamic parameters but without generating a diagnosis. Target group: adults and children from the age of 6, but no neonates. The patient has to be conscious during measurement. The Task Force • • • • •
®
Monitor offers the following functions:
3 channel ECG Oscillometric blood pressure Continuous “beat-to-beat” blood pressure Impedance cardiography External analogue input port (optional)
The software offers various possibilities of analyses, depending on the hardware used: • • • • •
Non-invasive beat-to-beat blood pressure measurement with automatic correction to oscillometric blood pressure (absolute values) Non-invasive evaluation of stroke volume and cardiac output for every heartbeat Evaluation of total peripheral resistance Evaluation of positive inotropy of the heart Real-time analysis of sympathetic tone and vagal tone derived from heart rate and blood pressure variability and evaluation of baroreflex sensitivity
All required basic knowledge for handling the software is described in chapter 7 of this manual. ® Additionally, you can consult the help function of the Task Force Monitor for every single step of daily routine.
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Use and function
2.2 Haemodynamic parameters ®
The Task Force Monitor system measures, calculates and displays the following parameters [5]. The selection and number of parameters depends on the software application; parts of the parameters listed are optional and not included in the standard application “Circulation”!
• RR-Interval (RRI) The RR-interval [ms] describes the time interval between two R-peaks in the ECG.
• Heart Rate (HR) The heart rate is the number of heart beats within a period of 1 minute. The HR is derived from the ECG signal using the following formula. The algorithm was published in [6] and [7]:
• Blood Pressure (systolic, diastolic and mean), Pulse Pressure (PP) These values [mmHg] are derived from the pressure curve of the continuous blood pressure device. As mentioned before the absolute values are corrected to the values assessed by the oscillometric device.
• Z0 Z0 [Ohm] is the impedance of the thorax derived from the ICG signal:
• Left Ventricular Ejection Time (LVET) LVET [ms] is the time between the opening (B) and closure (X) of the aortic valve (from the ICG). The X point is detected using the algorithm published in [8]:
• PreEjection Period (PEP) PEP [ms] is the time between R-peak of the ECG and the opening of the aortic valve (from the ICG):
• Stroke Volume (SV), Stroke Index (SI) SV is the amount of blood [ml] which the left ventricle ejects into the aorta with each heartbeat. Stroke Index SI is indexed to the Body Surface Area (BSA) of the patient.
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• Cardiac Output (CO), Cardiac Index (CI) CO is the circulating blood volume per minute [l/min]. CI is indexed to the BSA of a patient:
• Total Peripheral Resistance (TPR) and TPR Index (TPRI) 5 TPR is the resistance [dyn*sec/cm ] of the small and large vessels against which the left ventricle is pumping the blood. The default setting of the central venous pressure (CVP) is 3 mmHg. TPRI 2 5 [dyn*sec*m /cm ] is indexed to the BSA of the patient:
• Thoracic Fluid Content (TFC) The TFC [1/kOhm] is the total fluid content of the thorax:
• Index of Contractility (IC) IC [1000/s] represents the maximum blood flow during the left ventricular ejection (derived from the ICG):
• Acceleration Index (ACI) 2 ACI [100/s ] is the max. acceleration of the impedance signal (2nd deviation) between the opening of the aortic valve and dZ/dtmax (from the ICG):
• Systolic Time Ratio (STR) STR [%] is the ratio between PEP and LVET:
• Ejection Rate (ER) ER [%] is the ratio between LVET and the RR-interval:
• Left Ventricular Work Index (LVWI) LVWI [mmHg*l/(min*m²)] represents the work of the left ventricle for each heartbeat and refers to the BSA. PAOP is the Pulmonary Artery Occluded Pressure which is normally between 7 and 12 mmHg. The PAOP default setting is 7mmHg. • Mean Systolic Ejection Rate (MSER) MSER [ml/s] is the ratio between SV and LVET:
• Rapid Ejection Period (REP) REP [s] is the time between the R-peak of the ECG and the dZmax and represents a parameter for the contractility:
• Revised Heather Index (HIrev) HI [1/s²] is representative for the positive inotropy of the heart:
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Use and function
• Power spectra analysis of Heart Rate and Blood Pressure Variability (HRV and BPV) As known from literature [2] the sympathetic and vagal tone of the human autonomic nervous can be estimated from power spectra analysis. Vagal tone is represented by the high frequency band (HFband 0.15-0.4 Hz) of HRV, sympathetic tone by the low frequency (LF-band 0.04-0.15 Hz) of the BPV. Power spectra analysis is the frequency analysis of the RR-interval (RRI) and beat-to-beat systolic and/or diastolic blood pressure (sBP and dBP) signal (tachogram). Thus these time domain signals are transferred into the frequency domain. Several methods are described in literature, e.g. Fast Fourier Transformation (FFT), Wavelets, Wigner distribution or autoregressive parameters (AR) algorithms. The Task Force® Monitor program uses an adaptive autoregressive parameter (AAR) algorithm, which is described in [10] and [5]. • Baroreceptor Reflex Sensitivity (BRRS) The baroreceptors detect blood pressure variabilities within the cardiovascular system and pass this information on to the brain stem. The spontaneous baroreflex activity is determined by means of the Sequence-Method [11] which analyses and displays rising sequences (rising systolic blood pressure, extended RR-interval) and falling sequences (decreasing systolic pressure, shortened RR-interval) separately. The thresholds are defined with 4ms (RR-interval) and 1mmHg (blood pressure).
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Use and function
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2.3 Assembly of the Task Force® Monitor A short introduction will present you the essential parts of the Task Force
2.3.1
®
Monitor.
Front view of the Task Force® Monitor
3
7
6 1
5
4
2
Illustration 1. All connections at the front side of the device are for equipping the patient. The different coloured jacks together with the plugs of the patient-cables in according colours shall help avoiding interchanging them. In case a patient-plug is plugged into a wrong jack, the patient will not be at risk because no electric contact is produced. Note: all jacks are plugged in and pulled out. Do not twist the jacks at any time! ® The Task Force Monitor’s front contains the following elements: 1. 2.
Power indicator Black: (optional)
3. 4. 5. 6. 7.
Silver: Green: Red: Yellow: Silver:
External analogue port: please contact CNSystems Medizintechnik AG before connecting a device of a third party manufacturer. Air supply for continuous blood pressure device Continuous blood pressure device port ECG port ICG port Air supply for the oscillometric device
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2.3.2
Use and function
Rear view of the Task Force® Monitor
1
2
3
4
Illustration 2. ®
All connections at the Task Force Monitor’s rear side are for connecting the device with the PC and the power supply. ® The back of the Task Force Monitor contains the following elements: 1. 2. 3. 4.
2.3.3
Port for the IEEE 1394 (FireWire) cable (PN 00103) Type plate Master switch: I Device switched ON O Device switched OFF Mains plug
Connecting the Task Force® Monitor to the PC
The exchange of data between the Task Force (FireWire) cable (PN 00103).
®
Monitor and the PC takes place via IEEE 1394
Please handle the cable with care! In case a pin is twisted please contact a service technician.
Connect the mains plug with the Task Force
®
Monitor as well as with a power socket.
Do under no circumstances use an extension cord. The power supply system must be secured with 30mA.
Note: Only cables that were originally provided by CNSystems (or original cables built into the TFM cart) ® must be used to connect the Task Force Monitor.
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Task Force® Monitor – Operator’s Manual
Use and function
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Illustration 3. Connect the corresponding patient cables with the assigned jacks (colour code) of the main device. ® Only pull the grey part of the plug to detach the cables from the Task Force Monitor (see Illustration 4) Never twist connectors! Only pull!
Illustration 4.
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