IBP Precision Simulator IBPS 100 IBPS 110 Operation
Contents
1. Trouble shooting USB module not recognized Recognition of USB devices needs to be done in order USB driver is installed 1 Close MEDTEQ software if open correctly 2 Disconnect the USB module for 2s 3 Reconnect the USB module 4 Wait for the recognition sound 5 Start MEDTEQ software USB module stops Disconnect the USB module reconnect the USB module and re responding start the USB module Noisy signal patient Confirm the set up as described in 3 3 is implemented check monitor grounds are connected using a continuity tester Confirm the noise level with a static pressure The sample rates for some patient monitors are less than 10Hz which means the noise may be a result of sampling rather set up Confirm with the manufacturer that the patient monitor input is a type which is compatible with simulated signals at 5uV V mmHg 6 Contact details WhaleTeq can be contacted by the following means Email service whaleteq com Post No 17 1 Ln 181 Sec 1 Hangzhou S Rd Taipei Taiwan Phone 886 2 2394 8788 www whaleteg com Page 13 of 132. than 300kQ the voltage may be reduced accordingly If this is suspected use direct monitoring of the applied voltage as indicated in Section 2 4 www whaleteg com Page 5 of 13 aT WHALETEQ 3 Setup 3 1 Software installation IBP Precision Simulator User Manual 3 1 1 System requirements The WhaleTeq IBP Simulator system uses a normal PC to interface and control the USB module The PC should meet the following requirements Windows PC XP or later z Microsoft NET 2 0 or higher Administrator access if necessary for installation of software driver Free USB port Minimum 512MB RAM The system uses USB streaming based on 300ms packets of data which means the PC must be able to provide new data every 300ms For modern PCs this is a very low demand However screen savers background virus checking and other time based or CPU intensive functions may occasionally interrupt streaming of data Also PCs with low RAM 512MB or less and running many programs particularly Internet Explorer may force the PC to continuously use the hard drive which greatly increases the chance of interrupting the streaming of data For IBP simulation interruptions are rare and tend to occur only times which are not critical for tests for example returning from screen saver As such the latest version of software is instructed to ignore streaming errors In this event the USB module will loop the last Sms of stored data until the next p
3. These four wires will be Vs Sensor supply voltage normally 5V Vp Sensor differential output normally floating Vp Sensor differential output normally floating Vs Sensor supply voltage normally OV To identify which lead is which find whichever leads have a stable 5V between them These will be the Vs and Vs leads The remaining leads will be Vp and Vp respectively and are typically floating at around 2 5V In typical flat cables use for pressure sensors these are in order If Vp and Vp are incorrectly identified it is not a concern as they can be easily swapped after connection It is noted that some IBP sensors have additional leads which are intended for the patient monitor to identify the sensor In such cases users should contact the sensor manufacturer or measure the resistance to the OV line to determine the appropriate set up to complete the simulation 3 3 Environment noise reduction Due to the very low voltages involved a noise free environment may be necessary for testing IBP monitors This can be achieved relatively easily by using a metal bench or metal sheet underneath the DEVICE under test the USB Module and also connecting together the ground as shown IBP Monitor Frame ground a device under orEP terminal M n Test Metal bench metal sheet or foil With this set up turn the IBP monitor on and confirm that the level of noise is acceptable for tests For most tests this set up i
4. aT WHALETEQ IBP Precision Simulator User Manual WHALETEQ IBP Precision Simulator IBPS 100 IBP Simulator with resistor network Active and Passive IBPS 110 IBP Simulator without resistor network Active only Operation Manual Version 2014 03 01 For use with software versions 1 3 0 x www whaleteq com aT WHALETEQ IBP Precision Simulator User Manual 1 Introduction IEC 60601 2 34 2005 requires the following performance tests for the invasive blood pressure IBP function of a patient monitor Accuracy of pressure measurement static real pressure sources Accuracy of systolic dynamic real or simulated pressure sources Frequency response dynamic real pressure sources Alarm response time dynamic real or simulated pressure sources Although some of the tests in the standard refer to real pressure sources in many cases manufacturers of the monitor and sensor are different In this case under both product certification and medical device regulations it may be appropriate to test the patient monitor using simulated signals only using the industry wide 5uV V mmHg specification for IBP sensors Also for the frequency response test an alternate method is to test the patient monitor and sensor separately with the patient monitor tested by simulated signals and the sensor tested by step response On this basis WhaleTeq has developed a system which can perform all of the above tests using simulated si
5. acket arrives Users planning on long term simulation should take care to select a PC with sufficient RAM to avoid hard drive access disable screen savers and background virus checking 3 1 2 USB driver installation The system uses a USB mode called CDC which emulates a serial COM port for which Microsoft Windows already has the driver for this installed However it is necessary to link the USB Module to this driver which follows a process similar to installing a driver The linking file mchpcdc inf is available at http www whaleteg com products_ special 35 software Copy this file to a known folder When the USB is first connected select manual installation and point to older containing the above linking file Continue to follow instruction There may be a warning that he driver is not recognized by Windows which can be ignored This linking file is provided by Microchip for use with PIC microprocessors having in built USB function The same linking file is used for all WhaleTeq equipment and only needs to be installed one time Depending on policies of IT departments installation may require administrator access www whaleteg com Page 6 of 13 aT WHALETEQ IBP Precision Simulator User Manual 3 2 Test set up Connect the patient monitor to the simulator using a cable which exposes the four wires that are normally connected to the sensor i e cutting a normal cable or using a specially prepared connector
6. ged ampltude until the enter key is pressed SYS DIA remains constant ff frequency is set to zero SYS DIA are ignored and static pressure MAP 4 5 Output sine wave pressures in active mode Sine waves can be output using the Active Simulation EE REA Ace Sinaia Static Dynamic pressures with a frequency other than Settings static sine 0 0Hz SYS 120 02 mmHg If the SYS value is adjusted the DIA value is not modified unless the user attempts to set the SYS below DIA value The MAP is automatically updated based on SYS DIA 2 MAP 1100 0 mmHg DIA 80 04 mmHg Freq 1 0 H Hz Similarly if the DIA value is adjusted the SYS value is not MAP automatically adjusted ips i when SYSor DIA are changed modified unless greater than SYS MAP is automatically if MAP changed amplitude updated SYS DIA remains constant F frequency is set to zero SYS DIA are ignored and If MAP value is adjusted SYS and DIA are adjusted by the EON peonnin MAP same amount provided range limits are not exceeded o 50mmHg 330mmHg ae Output For the alarm tests in IEC 60601 2 34 it is recommended to use the MAP to quickly adjust the pressures higher or lower The system will only change the pressure after the completion of a full cycle e g 1s at 1Hz uo www whaleteg com Page 10 of 13 aT WHALETEQ IBP Precision Simulator User Manual Passive Simulation 4 6 Passive simulation Settings When pass
7. gnals The system provides the following features and functions Active electrical simulation of pressures using a precision divider with voltages output at 5uV Vs mmHg where Vs is the measured or set sensor supply voltage Active simulation includes the following types of output e Static pressures constant output voltage e Dynamic pressures sine waves up to 40Hz e BioSim Mode a sample of real biological waveform but with adjustable SYS DIA and heart rate e Biological waveforms based on samples from the Pysionet website z Internal measurement of sensor supply voltage allows the system to automatically adjust for the sensor supply E An output that tracks the sensor voltage at 100mV 1mV output e g a full scale output of 7 5mV equivalent to 300mmHg this output has 750mV Passive simulation of static pressures using a network of precision resistors The WhaleTeq IBP Simulator is based on WhaleTeg ECG technology which in addition to standard waveforms e g sine can be used for streaming of biological arterial blood pressure waveforms such as those from the Physionet website Contact WhaleTeq for more details Important note Simulation is provided based on 5uV V mmHg Most sensors are slightly non linear with the output falling by 2 4mmHg 1 at 300mmHg the exact amount depends on the sensor Most patient monitors compensate for this by non linear compensation Therefore when testing by simulation many patient mo
8. his system assumes a floating isolated measurement circuit in the IBP monitor i e Type CF patient isolation If the circuit is not isolated and the system grounds are common there may be sufficient noise to introduce errors www whaleteq com Page 3 of 13 aT WHALETEQ IBP Precision Simulator User Manual 2 2 Active simulation When active simulation is selected the USB Module outputs voltages based on S5uV V mmHg Although most IBP monitors use a nominal supply voltage of 5V i e sensor output of 25uV mmHg this voltage is nominal only and typical systems only control this to around 1 Therefore for accurate simulation the IBP monitor s supply voltage should be known The USB module incorporates a function to accurately measure this supply voltage which is then used to calculate the simulation voltage more precisely e g if the supply voltage is 4 980V the USB module will create voltages based on 24 9uV mmHg This function is only performed on demand i e when the user presses the button to measure the voltage and can only be accessed in the Off mode The user can also override this function at any time and manually enter the supply voltage if required When dynamic waveforms are output the waveform data is continuously streamed from the host PC to the USB Module 2 3 Passive simulation If passive simulation is selected the output is switched over to an isolated network of resistors which accurately simula
9. imary purpose of demonstrating that the IBP simulator can be used for streaming such waveforms Users that are interested in streaming real biological waveforms can contact WhaleTeg to arrange a special software interface Users should take the responsibility to find the appropriate waveforms and extract the data in a simple format 4 8 2 Output lo x Press the Select Waveform button to The following are selected samples of real biological waveforms from the Physionet website Contact MEDTEQ f particular waveforms or durations are required open a small screen On this screen select the waveform of interest The output will automatically start playing the selected record as soon as a waveform is selected This screen can remain open so users can easily switch between waveforms and view the output When selecting this mode the Biological Waveform Control panel becomes active allowing users to start stop reset return to the start and navigate the waveform in steps of 10s or 60s to get to a point of interest As the current samples provided are only 40s to 60s these function have little meaning and intended for users with longer duration records Biological Waveform Control Play time 935 Sop _Reset Sts 10s 10s 60 The output can be viewed both on the patient monitor and the graphical screen www whaleteg com Page 12 of 13 aT WHALETEQ IBP Precision Simulator User Manual 5
10. is can be done with a setting of OmmHg With a setting of 0 0mmHg confirmed zero the patient monitor IBP function and any peripheral monitoring equipment Important note all metal to metal contact will create small potentials due to thermal emf s and oxidation Use only the terminal block provided no other terminals switches etc Tighten the terminal block firmly without excess avoid movement of the terminals and if testing over very long periods occasionally loosen retighten the terminals to avoid potentials caused by oxidation Always re zero the system after connection to the terminals In case of doubt about the contact quality solder directly to the terminals under the terminal block Allow time to cool to ambient before zeroing the system www whaleteg com Page 9 of 13 aT WHALETEQ IBP Precision Simulator User Manual 4 4 Output static pressures in active mode Main Function Active Simulation Settings static sine Voltages simulating static pressures can be output using Active Simulation Static dynamic pressures and with a frequency setting of OHz SYS 120 0 mmHg In this case SYS and DIA pressures are ignored and the MAP 120 03 mmHg static pressure is output based on the MAP mean arterial pressure setting DIA 120 04 mmHg Freq 0 0 H Hz The user can adjust the MAP with the up down buttons or diresped type in directly For direct typing the output does not change F MAP chan
11. ive simulation is selected the panel to select the simulation value will be made available Internally the USB module will switch over to an isolated network of precision resistors An audible click of the relays can be heard when changing settings For highest accuracy when changing over from active to passive simulation users should remember to zero the systems again as the zero offset in the active network may be slightly different to that in the passive network 4 7 Active simulation BioSim Mode The BioSim mode refers to a normalized sample of a one Main Function BERK Simulation cnt Siei etti static si ettings BioSim beat from a real biological waveform2 which can then be eee eel adjusted for heart rate systolic and diastolic pressures a SYS Oz sys 120 03 mmHg c Passive Simulation x amp Static pressures 0 1 MAP 07 mmHg DIA 80 0 a mmHg This waveform is considered more appropriate for testing toere DIA O02 mms Bet 60 02 bpm the ability of the patient monitor to detect SYS MAP DIA C alendo Frec He Ths outputs a repeated ce 7 a om pressures than testing with sine waves S MAP automaticaly adisted Sern aaa At a heart rate of 60bpm monitors usually detect SYS DIA values correctly At higher heart rates the test signal is compressed and has higher frequency components O ee Some reduction in the indicated SYS value can be expected in this case as patient monitors normally low pass filtering A large
12. nitors will show slightly higher readings than expected especially at the higher pressures From experience the typical error at 300mmHg is around 2mmHg with a maximum of 4mmHg This error is well within the allowable limit of 12mmHg On request MEDTEQ can provide special software that simulates a real sensor including specified non linearity as provided by the sensor manufacturer www whaleteg com Page 2 of 13 aT WHALETEQ 2 System Description IBP Precision Simulator User Manual 2 1 Overview The system consists of the host PC PS a USB Module and the device under test DUT usually a patient monitor or other equipment for direct measurement of blood pressure Patient monitor ames Sensor Host PC mE mechintimules 4 wires BP device PC USB 2 0 Semone under test 2 ainidi DUT The host PC provides commands to the USB Module to set up relays or output voltage depending on the mode selected by the user The USB Module has the following connections Vss Voltage Vo ua IBP sensor Monitor Vos Vo 5 x Vs Vs pV mmHg __ 4 Voltage a Vo connection monitor Vokuae V see 2 4 Monitor IGP sensor mps connection IBP Precision Simulator GND For use with IEC 60601 2 34 tests Active simulator for dynamic and static testing Passive Resistor Network for static testing Using 5uV V mmHg Check calibrate before use USB2 0 vs oe Important note t
13. put mV Example measured sensor supply voltage is 4 980V and the sensor was found to have a 1 loading effect mV output was 1 lower than expected In this case setting the sensor supply voltage to 4 980 x 1 01 5 030V will compensate for the loading effect www whaleteg com Page 4 of 13 aT WHALETEQ IBP Precision Simulator User Manual 2 5 Specification 2 5 1 Active simulation Design Specification Notes Output voltage range 1 25mV 8 25mV Equivalent to 50mmHg 330mmHg DAC resolution 2 2uV 1 LSB Overall Accuracy 5uV1 DAC compensation applied for increased accuracy EOT Drift nn mee 30 min After 10 min warm pE u Output Noise S Noise 20W Frequency range Sine 0 40Hz ee rate 5kHz filtered at 720Hz Frequency accuracy SOppm crystal streaming voltage leads 8 tf measurement accuracy 2 5 2 Passive simulation Design Specification Notes Sensor load resistance 1 33kQ Resistance between sensor supply voltage leads 0 1 full scale 0 05 resistors used Network values 300 240 150 60 30 0 30 Matches the values in IEC 60601 45mmHg 2 34 for 300mmHg full scale 2 5 3 Other Design Specification Notes o Power supply USB 5Vdc 0 3A USB high powered mode Environment 15 C 35 C By design only not tested 35 80 RH lt 2uV drift after warm up The output divider uses a 1000 resistor If the input impedance of the patient monitor measurement circuit is less
14. reduction may for example indicate the monitor is not suitable for neonatal applications The profile of the wave is shown as follows The MAP mean arterial pressure of this waveform can be calculated from MAP 0 6913 x DIA 0 3087 x SYS For example for SYS DIA settings of 120 80 the MAP is 92 3mmHg The raw data used for this waveform is available on request 2 Beat sample data is taken from Physionet database MGH MF database Signal No MGHOO2 13 minutes into the record www whaleteq com Page 11 of 13 aT WHALETEQ IBP Precision Simulator User Manual 4 8 Active simulation Biological waveforms 4 8 1 Background This mode allows streaming of data of sample waveforms from the Physionet website For WhaleTeg multichannel ECG system MECG the software can interface directly with the Physionet website to download a large number of waveforms using Format 16 or Format 212 It was originally intended to adapt this software to allow streaming of arterial blood pressure waveforms as found in the multi parameter databases such as MGH and MIMIC However these multi parameter databases were found to be difficult to negotiate via a direct download Storage formats have also be found to be unusual and many of the blood pressure waveforms are not useful just noise or static pressure Therefore WhaleTeq has taken a small selection of biological waveforms with samples of typically 40 60s with the pr
15. s satisfactory without any special efforts Important note this system assumes a floating isolated measurement circuit in the IBP monitor i e Type CF patient isolation If the circuit is not isolated and the system grounds are common there mav be errors introduced www whaleteq com Page 7 of 13 aT WHALETEQ IBP Precision Simulator User Manual 4 Operation 4 1 Main Screen Selects the type Selects ine Selects the parameters for active of function to be s parameters for simulation of static or output neonate active simulation of P BioSim waveforms Selects the pressure for passive simulation of pressures isolated resistor network IEJ MEDTEQ IBP Simulator 1 0 s w Version 1 3 0 0 aan Jia n a Be Batic j eal tay ti pe tases Play control for _3 cal biological waveforms 4 Graph range Graphical display of output waveforms Functional blocks that are not related to the mode selected are shaded out in normal use The function to Measure Sensor Voltage is available only in the Off mode www whaleteq com Page 8 of 13 aT WHALETEQ IBP Precision Simulator User Manual 4 2 Setting the sensor supply voltage Measure Sensor Voltage Before using any active simulation mode the sensor supply voltage must be set as the output of a real pressure sensor is proportional 5 017 Vdc to the supply voltage r Allow manual adjusting sensor supply voltage The sen
16. sor supply voltage can be set in two ways 1 Click the button Measure Sensor Voltage The system will automatically measure the supply voltage coming from the patient monitor or IBP system Note this button is only available in the Off mode 2 Click the check box to allow manual adjusting With this checked the user can enter voltage manually For the purpose of calibration the nominal value of 5 000V is used so that output is exactly 25uV mmHg or 7 500mV for 300mmHg When the software is started the default value is 0 000V If any active simulation mode is selected and the voltage remains at 0 000V a warning message will be displayed and the sensor voltage set to the nominal value of 5 000V 4 3 System zero offset Because of the very small voltages involved there are normally small dc offsets in every system which are significant with respect to the 0 1 full scale specification 7 5uV Before testing or performing a calibration check the user should zero all items of equipment at the same time to eliminate this offset This includes the device under test IBP or patient monitor WhaleTeq IBP Simulator i e set up 0 0mmHg any equipment used to monitor the voltage either directly at the VD terminals or at the Voltage Monitor terminals For active simulation this can be with a static output of 0 0mmHg or in the Off mode after the sensor supply voltage is set For passive simulation th
17. te 5uV V mmHg to within 0 1 of full scale Control of this network is by internal relays The benefits of this circuit are a It is not necessary to know or adjust for the supply voltage the resistive network will act proportionally b Less noise passive isolated circuit only c Precise the network has been created out of 0 05 resistors to ensure the 0 1 requirement in IEC 60601 2 34 is met 2 4 Voltage monitor The voltage monitor connects directly to sensor terminals Vp and Vp It allows the user to monitor the actual mV being supplied to the IBP sensor input This terminal can be used for calibration or alternately to monitor the applied voltage using a calibrated reference meter during the tests The latter approach allows you to avoid having to calibrate the WhaleTeq IBP simulator In some cases the IBP monitoring device patient monitor may slightly load the applied voltage The simulator output impedance is 1000 Normally sensor input circuits are high impedance with negligible loading However it is possible the input circuits are designed with less than 100kQ input impedance in which case the output voltage will drop depending on the impedance e g 10kQ will cause the output to drop by 1 100kQ by 0 1 In these cases the test can still be performed by using a reference meter to monitor the true applied voltage The sensor voltage can be manually adjusted so that the set mmHg will correspond accurately to the out
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