Med-Storm Stress Detector™ User manual - Med
Contents
1. Hicmsiemen g m area small peaks E E E aor ail oar dm te Pee IN HP MM AMR SEEL JEF EL MN l l l l n 5 CEC 1 mm I 1 1 ri 55 seconds md ee ee eee eee Ene lt n Ee Ee Ee ee eee m a W End FJ eee lt 0 15 5ec I F seconds Figure 4 18 Calculation of area small peaks Area under curve micro Siemens seconds uSs In some situations it is valuable to look at the larger of the two measures Area huge peaks and Area small peaks This is then referred to as Area under curve Signal quality Signal quality is not a measurement value but is used to determine when measurement values are reliable It is shown as a horizontal bar in the interface and when the signal quality falls below a certain limit the background of the detailed graph gets a yellow colour There are two ways signal quality is measured for each the warning limit giving yellow background can be set in the configuration dialog The first quality index measures the distortion of the reference signal applied to the skin Normally the signal is clean and the index has a small value However it will increase in the presence of other electrical devices attached to the patient such as electro coagulation devices that disturb the reference signal The second quality index provides a check of the integrity of the measured signal It detects external interference2. Connection lost to SN oe we MU and with an orange background in the w in graph KUK gt SS l Figure 4 32 Contact lost warning Version 1 0 ENGLISH EUROPE 24 Med Storm Stress Detector User Manual 5 Care and maintenance Routinely inspect all electrical plugs and connections Do not use if damaged 5 1 Life time The minimum life time of the system is 5 years conditional that the instructions in this manual are followed 5 2 Preventive maintenance The Stress Detector does not need to be calibrated during specified lifetime years presuming the instructions in this manual are followed The latest version of the Med Storm application software will always be available for download from www med storm com Please follow the setup instructions when installing or upgrading 5 3 Simplified function tests 1 Start the PC unit and the measuring unit 2 Make sure that the needed connections do not have any visible damage and are connected correctly according to instructions in chapter 4 1 Instrument setup 3 Start the Stress Detector application software according to chapter 4 3 2 Getting Started 4 Verify that a graph is created in the Stress Detector application software window and that the current measurement values are presented 5 4 Support information support med storm com Skype med storm support Tel 47 909 398 10 5 5 Cleaning Always disconnect the Stress Dete
3. IEC 60601 1 2 Electromagnetic compatibility IEC 60601 1 2 IEC 60601 1 4 Programmable electrical medical systems IEC 60601 1 4 UL 60601 1 Medical Electrical Equipment UL 60601 1 Version 1 0 ENGLISH EUROPE 30 Med Storm Stress Detector User Manual Appendix D Electromagnetic compatibility Guidance and manufacturer s declaration electromagnetic emissions The Stress Detector is intended for use in the electromagnetic environment specified below The customer or the user of the Stress Detector should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group 2 The Stress Detector must emit CISPR 11 electromagnetic energy in order to perform its internal function Nearby electronic equipment may be affected RF emissions Class B The Stress Detector is suitable for use in CISPR 11 all establishments including domestic establishments and those directly Harmonic emissions connected to the public low voltage IEC 61000 3 2 power supply network that supplies buildings used for domestic purposes Voltage fluctuations flicker Complies emissions IEC 61000 3 3 Table D 1 Electromaagnetic compatibility 201 Version 1 0 ENGLISH EUROPE 31 Med Storm Stress Detector User Manual Guidance and manufacturer s declaration electromagnetic immunity The Stress Detector is intended for use in the electromagnetic environment specified below The custo
4. It is possible to transport the system worldwide by air road ship and train The Stress Detector system meet requirements in EMC ESD accordance with IEC 60601 1 2 Electromagnetic compatibility Version 1 0 ENGLISH EUROPE 27 Med Storm Stress Detector User Manual Appendix B Technical specifications Measurements Noise level 1 6 below 0 002 uS accuracy This applies for resistive measurements on 100 uS Measurement range Classification of Class II A medical device Maximum current 36 uA RMS definition The maximum value of current that can be supplied to a patient trough the C electrode Storage capacity Disc capacity is 2 GB Power supply The measuring unit operates on power from an external power supply of medical grade Do not use any other than the recommended power supply unit PD M60US24 unless it has been tested and verified by Med Storm that it works together with the Measuring Unit Mains power input to measuring unit power supply is 100 240VAC 50 60Hz PC operates on power from an external power supply Mains power input to PC power supply is 100 240VAC 50 60Hz Power consumption is 53 W PC 50 W MU 3W Table B 1 Technical specifications PC minimum configuration Windows XP or Windows Vista Minimum 512 Mbytes RAM Minimum 10GB Hard drive CD ROM drive or compatible media RS232 port or USB RS232 adapter When a PC is connected the user must ensure that the entire system meet re
5. The customer or the user of the Stress Detector should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance Electromagnetic environment guidance level Portable and mobile RF communications equipment should be used no closer to any part of the Stress Detector including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 12 P li Conducted RF 3 Vrms 3 V d IEC 61000 4 6 150 kHz to 80 MHz d 2y P 80 MHz to 800 MHz d 238 V P 800 MHz to 2 5 GHz Radiated RF 3 V m 3 V m where P is the maximum output power rating of the IEC 61000 4 3 80MHz to 2 5GHz transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol 9 NOTE 1 At 80MHz and 800MHZz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflected from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateu
6. such as ESD discharges near the equipment which may cause spikes in the measurement data Both indices are compared to the threshold settings in order to provide a warning that the quality of the measurement may not be trustworthy For further information on the quality index see also chapter 4 4 Version 1 0 ENGLISH EUROPE 17 Med Storm Stress Detector User Manual 4 3 4 Choose application mode Choose between different application modes by touching anywhere in the 000 000 Application Mode field and then mark one of the modes Pateni 123 ABC The different modes affect which measurement values are displayed above the graph windows aa o BPMPRRM Figure 4 19 Choose application mode Anaesthesia In the Anaesthesia application mode the pi measurement values shown are 0 i BERE fe Area under curve Peaks sec Average Peak Average Rise Time Signal Quality ae 7 A D RA Figure 4 20 Anaesthesia mode If the Area under curve measure is 0 uSs the patient is sufficiently or to much sedated Peaks per seconds shows if there 1s any sympathetic nerve activity in the patient during anaesthesia Noxious stimuli discomfort without awakening give less forceful sympathetic nerve firing than noxious stimuli discomfort with awakening If the peaks sec gt 0 07 at patients in anaesthesia the patient has stress discomfort and the patient may need more analgesia If the Area under the curve ap
7. thus the virus software needs to be updated This update procedure may also affect the Stress Detector application software functionality temporarily or permanently To avoid potential hazards associated with the management of virus protection software the following rules shall be followed I All installation or update of virus protection software on the PC Unit shall be supervised 2 After installation or update of virus protection software or definition files a functional test must be executed 3 If virus has been detected on the PC Unit and rendered harmless a functional test must be executed to verify that functionality was not affected Version 1 0 ENGLISH EUROPE 35 Med Storm Stress Detector User Manual Appendix F Pre use checklist Cheek 0 Signature Verify that the system is not going to be used with a patient with skin condition which may affect skin conductance e g injury of the skin Verify that the system is not going to be used with a patient with electrically sensitive life support system e g implantable pacemaker or defibrillator Verify that the system is not going to be used when the patient has an injury affecting the sympathetic skin nerves Fa 48 hours in row on the same patient Verify that the electrodes are placed according to this ee manual Ch 4 2 2 for adults Ch 4 2 3 for premature infants Verify that the electrodes are of the correct type and approved by Med Storm Verif
8. typing on the on screen keyboard When finished touch the on screen keyboard Enter button When the ID 1s written the data starts to be saved l i Figure 4 9 Enter Patient ID Version 1 0 ENGLISH EUROPE 12 Med Storm Stress Detector User Manual anywhere within the Application 0 00 000 E Mode field and then point on the desired mode In these Getting started instructions we choose the Anaesthesia mode For further information about the different modes se chapter 4 3 3 s kg Hue Figure 4 10 Screen mode Anaesthesia 6 The Start button automatically turned into a Stop button when the patient id was entered The date and time when the measurements took place are shown above the graphs Patent 123 ABC 0 00 00 EN 0 00 0 00 ry i gt I gt Q Qt ry F a Pa A Figure 4 11 Start Stop button Figure 4 12 Measurement date and time 7 Verify that a graph is seen in the Skin Conductance uS window and that an overview is created in the graph window to the right Calculated measurement values for the data visible in the left graph are updated continuously Version 1 0 ENGLISH EUROPE 13 Med Storm Stress Detector 8 To end and store a session use the Stop button The button will turn into a Go online button and the location where the file is stored is shown above the graphs 9 To start measuring again to
9. 2 23 3 8 7 8 For transmitters rated at maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE I At 80 MHz and 800 MHz the separation distance for 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 D 4 Recommended separation distances 206 Version 1 0 ENGLISH EUROPE 34 Med Storm Stress Detector User Manual Appendix E Protection against data virus Data virus is a threat to the functionality of the Stress Detector PC Unit The following actions reduce the risk for virus attacks on the PC 1 Do not use diskettes or CD s in the computer 2 Protect the network on which the PC resides with a firewall 3 If considered necessary install virus protection software on the PC Unit Management of virus protection software A virus protection software running on the same computer as the PC Unit may interfere with the Stress Detector application software functionality It may slow down the computer while inspecting files for virus or it may affect the Stress Detector application software when removing a detected virus New data viruses appear and
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11. Med Storm Stress Detector User Manual Med Storm Stress Detector 069 040 ai User manual VERSION 1 0 ENGLISH EUROPE Part number 4001 Manufacturer Distributor Med Storm Innovation AS Gimle Terrasse 4 NO 0264 Oslo Norway Telephone 47 90 93 98 10 Internet C E 0413 Version 1 0 ENGLISH EUROPE Med Storm Stress Detector User Manual IMPORTANT The user manual covers the operation of the MED STORM Stress Detector Read all instructions warnings and precautions prior to use Only a trained physician or anaesthesia nurse should use the system Users of the equipment must be familiar with the medical aspects of the conditions for which the MED STORM Stress Detector is used MED STORM considers itself responsible for any effects on safety reliability and performance of the equipment only if assembly operations extensions re adjustments modifications or repairs are carried out by persons authorized by MED STORM and the electrical installation complies with national standards and installation and configuration of software is carried out by persons authorized by MED STORM and no other software is installed on the computer or the Measuring unit unless explicitly accepted by MED STORM and the equipment is used in accordance with the product documentation MED STORM makes no warranty of any kind with regard to this material including but not limited to the implied warranties of merchantability and
12. The following instructions describe all necessary steps required to set up and operate the Stress Detector Note This system must not be used on a patient with an implanted pacemaker or defibrillator Note The device shall not be used on patients with skin conditions which may affect skin conductance e g injury of the skin or when the patient has an injury affecting the sympathetic skin nerves Note Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in Appendix D Note Portable and mobile RF communications equipment can affect medical electrical equipment 4 1 Instrument setup When assembling the system a power supply holder is mounted together with the table stand The holder is placed between the PC and the table stand and shares the same screws as the stand 1 Connect the power cable to the MU See 1 Figure 3 4 and Figure 3 5 2 Connect the communication cable to the MU The connector is keyed for correct connection Make sure the groove 1 is aligned with the peg on the MU connector Tighten the threaded locking collar for a secure connection Figure 4 1 Communication cable connecting to the MU 3 Connect the communication cable to the COM1 port on the PC Secure the cable by tightening the screws clockwise 4 Connect the power cable to the PC Make sure the connector is orientated according to
13. Visual Analog Scale NFSC Number fluctuations of skin conductance 1 2 Intended use The Stress Detector is intended to work as a secondary monitoring device for depth of anaesthesia and pain level It may only be used as a supplement to other clinical methods 1 3 Normal use Normal use is 24 hours day 200 days a year Do not use continuously for more than 48 hours 1 4 Intended user Only trained physicians or anaesthesia nurses shall use the system 1 5 Indications for use Indications for use are for e adult patients undergoing anaesthesia e preterm infants e postoperative patients e intensive care patients 1 6 Contraindications for use e The device shall not be used with patients with skin conditions which may affect skin conductance E g injury of the skin e The device shall not be used with patients with electrically sensitive life support systems e g implantable pacemaker or defibrillator e The device shall not be used when the patient has an injury affecting the sympathetic skin nerves 1 7 Pre use checks Before using the device we recommend filling in the pre use checklist from appendix F for each patient Version 1 0 ENGLISH EUROPE l Med Storm Stress Detector User Manual 2 Warnings Read the entire operating manual before operating this Stress Detector It is the responsibility of the user to ensure that any applicable regulations regarding the installation and operation of the Stress Detector
14. are observed The Stress Detector must be used together with dedicated software and accessories 2 1 Electrical shock hazard There are exposed voltages inside the measuring unit There are no user serviceable parts inside Do not open the measuring unit Send to qualified personnel approved by Med Storm Innovation for servicing 2 2 Environmental conditions Do not use transport or store above or below the recommended environmental intervals in Appendix A Do not immerse the Stress Detector or cables in any liquid or allow liquid to enter plugs or connections Do not use cables if connectors become wet 2 3 Warning and information symbols The following symbols are used on the Stress Detector as warning and information symbols Warning symbol Read the entire operating manual before operating this Stress Detector Information symbols The parts applied to the patient are insulated from the box and mains according to body floating BF model described in IEC60601 1 Do not dispose of this unit It should be returned to Med Storm Innovation for proper material reuse or recycling Table 2 1 Warning and information symbols Version 1 0 ENGLISH EUROPE 2 Med Storm Stress Detector User Manual 3 Technical overview Technical manual 3 1 System overview The Stress Detector is an electronic conductance meter for detecting electrodermal response EDR on palmar and plantar skin sites Note The use of accessories tran
15. be touched to perform specific actions Areas outlined in black are areas referred to in the text The software is developed for touch screen use but can also be operated with a mouse connected to the PC 4 3 1 Stress Detector user interface overview 3 4 Figure 4 6 Stress Detector user interface overview 1 Patient ID field 9 Event marker 2 Current measurement values 10 Close the Stress Detector 3 Skin conductance graph Application software 4 Time scroll bar 11 Auto fit time scale to 15 sec 5 Start Stop Go online button 12 Zoom out 6 Load saved data 13 Zoom in 7 Export data to Excel format 14 Overview graph 8 Configure settings 15 Choose application mode Version 1 0 ENGLISH EUROPE 11 Med Storm Stress Detector User Manual 4 3 2 Getting started 1 Turn on the computer using the on off button Se part 3 3 Computer 2 The Stress Detector application software should auto start If not touch the desktop icon SCMS to start the Stress Detector application software Figure 4 7 Start SCMS software 3 The Stress Detector application software pen gt starts and following window will be 0 00 000 iiimmm visible on the screen The software starts in a mode that shows measured data without saving it 4 To enter an ID for a patient touch the Patient ID box and a keyboard window will appear on top of the Stress Detector software window Write a patient ID by
16. ce value between the identified maximum and minimum of one peak is its peak value The average is calculated from all peaks in the time window Rise time micro Siemens per second uS s Rise time is the rate of increase or decrease from the start to the end of the measurement window Area huge peaks micro Siemens seconds uSs Best for measuring awakening during anaesthesia This measure is calculated by establishing a horizontal base line from the first peak minimum in the time window The area that 1s calculated 1s the accumulated difference between the conductance values at the registration curve and the established baseline when they are larger than the baseline This 1s illustrated in Figure 4 17 Micmsiemens ad FD GO IN SD OK ON E EE ee A Area huge peaks ET oo a S a PTE TU ma AV yy Cee eA tA TT PM TT tt Fyr TT 3 I A E 8 34 I I I I I ae SEL I I I I I I 1 1 I 1 I I 1 I I 0 55 seconds I F seconds Figure 4 17 Calculation of area huge peaks Version 1 0 ENGLISH EUROPE 16 Med Storm Stress Detector User Manual Area small peaks micro Siemens seconds uSs Best for measuring noxious stimuli during anaesthesia This measure is calculated by establishing a line between two adjacent peak minimum points The area is the accumulated difference between the line and the skin conductance registration curve values when they are larger than the line This is illustrated in Figure 4 18
17. ctor and accessories from its power supply before cleaning After each patient the electrodes used shall be removed and the Stress Detector and its accessories may be cleaned by wiping a clean cloth dampened with 70 isopropyl alcohol or mild hospital cleaning detergent bactericide Note Under no circumstances should the Stress Detector and accessories be immersed in any liquid cleaning agent Nor should it be exposed to steam or hot air sterilisation or chemical sterilisation using ethylene oxide Never use ether or petroleum based solvents Version 1 0 ENGLISH EUROPE 25 Med Storm Stress Detector User Manual 5 6 Scrapping instructions All parts of the Stress Detector are to be returned to Med Storm Innovation AS for proper electronic material reuse or recycling Do not dispose any part of this unit Version 1 0 ENGLISH EUROPE 26 Med Storm Stress Detector User Manual Appendix A Environmental and handling conditions Measuring Unit Operating Ambient temperature 10 C 30 C Ambient pressure 700hPa 1060hPa Ambient humidity 30 75 Transport Ambient temperature 10 C 70 C Ambient pressure 500hPa 1060hPa Ambient humidity 10 90 Storage Ambient temperature 10 C 30 C Ambient pressure 700hPa 1060hPa Ambient humidity 30 75 Degree of enclosure IP XO protection Vibetion Shock Bann It is possible to transport the system worldwide by air road ship and train Drops ives fall
18. down to the fixing position 8 Connect the mains cables to both power supply units and a wall socket 4 2 Skin electrode placement The electrodes can be attached to the patient with reliable measurement result for a maximum time of 48 hours Note To disconnect pull out each electrode connector separately Do not pull on the electrode cable itself Figure 4 2 Correct way of disconnecting Figure 4 3 Do not pull on the electrode cable the electrodes itself Version 1 0 ENGLISH EUROPE 8 Med Storm Stress Detector User Manual 4 2 1 Artifacts Artifacts can be seen when moving the hand foot where the electrodes are attached or by pulling at an electrode Artifacts can also be seen if the electrodes are attached to injured skin Artifacts have been seen in the registration during tetanic stimuli 1f there were more than one EEG Electroencephalography monitor connected to the patient 4 2 2 Skin electrode placement on adults The intended placement of the electrodes on adults is on the palm of the hand 1 Place the electrodes according to Table 4 1 and Figure 4 4 The distance in between each electrode shall be at least 7 mm The M electrode is placed at the hypothenar emminence because this area on the palm gives highest stability and thus less movement artifacts 2 Attach the connectors of the electrode cable to the electrodes according to Table 4 1 in Figure 4 4 color Reference R Blue Below long finger of the
19. e chosen Choose a recorded session and then choose the data and time point of the session and touch the Ok button If no or the wrong files are available when touching the Load patient button another path than the desired are chosen in settings Export recorded data D u i rman The files available depend on which data path that has been set Figure 4 29 Load patient User Manual Anaesthesia DP I amp IR To use the Export feature a mouse and keyboard must be used The Export feature will work on computers with Microsoft Excel and Med Storm software installed If Microsoft Excel is not installed on the computer used for recording measurement data then the data file can be moved from the recording computer to the Excel computer with e g a USB memory stick See chapter 4 3 6 On the Excel computer the data can be read with the Load Patient function in the Med Storm software program and then exported to Excel To export recorded data to Excel use the button Export to Excel An export tool will appear on the screen where the export preferences can be set The export tool will export information that is inside the detailed graphs timeframe By using the scroller under the detailed graph or by changing the value in the start time field inside the export tool the start time for the export can be changed The timeframe can be changed either by using the zoom buttons or by chan
20. fitness for a particular purpose MED STORM shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing performance or use of this material DISCLAIMER THE MED STORM STRESS DETECTOR IS NOT A SUBSTITUTE FOR YOUR PROFESSIONAL JUDGMENT MED STORM SHALL NOT BE LIABLE IN ANY MANNER WHATSOEVER FOR THE RESULTS OBTAINED THROUGH THE USE OF THE STRESS DETECTOR PERSONS USING THE STRESS DETECTOR ARE RESPONSIBLE FOR THE SUPERVISION MANAGEMENT AND CONTROL OF THE STRESS DETECTOR Version 1 0 ENGLISH EUROPE Med Storm Stress Detector User Manual TABLE OF CONTENTS Th MRO CIC TO ers caisstesep coe cts cz stecpe sense a E E EE R l 1 1 VEI er EA E E l MONET i Me NAL eee l TA 21910 210 US EEE E T ji to MEET Pr l 1 6 Contraindications for USE sessies na Ea EASE E 1 AR 000 EEE l ETE EEE EEE EEE 2 2 1 Electrical shock hazard icici ncssvvassssscesinssnavvaneaensvdsnacvossooatsedssssatcauteadsberanieurseians 2 2 2 Environmental conditions rrrrrrrrrrrrnnvrrrnrrrrrnnnrrnnnrernnvrrrnnrrrrnnnrrnnssrrnnnnnvensenn 2 2 3 Warning and information symbols rrnrrrrronnvrrrennvrrrennvrrrennvrrrennvrrrsnnvrenennnn 2 3 Technical overview Technical manual rrrrrrnrnnnrrrrnnnnrrrrrnnnnrrrrrrnnvrrnrnnnnnvnnnnnnnr 3 3 1 System VEVEN wi ice css ccaesnssc dunner av ensivinaengatichatiseasbncdenscnseivasnoetiiedat avedecsassdncavaseis 3 g2 NESNA 4 3 2 1 FO UNN 5 393 8
21. ging the value in the duration field inside the export tool The box Auto update will be unchecked if the Start time and Duration fields in the export tool are used to set the time window If measurement data is to be exported change the Duration or the start time until the whole timeframe of interest is shown in the detailed graph after using Show Alternatively use the time scroller and zoom tool to select the timeframe of interest Keep the Auto update box checked if using the zoom buttons or the scroller to set the desired time window Version 1 0 ENGLISH EUROPE Excel Export Start time 2007 11 20 17 05 33 Stop time Duration s 15 Auto update measurements IPEE I Excel Export Start time 2007 11 20 17 06 33 Duan ls Auto update w Export analysis EP measurements e 25 Med Storm Stress Detector User Manual When the button Export Measurements is selected the user will be able to insert a Figure 4 30 Export data comment in the excel sheet before Microsoft Excel is started and the measurement values are exported If the button Export Analysis is selected all derived analysis values will be inserted to one row in an excel workbook For each time the button Export Analysis is selected a new row with the analysis values for the detailed graph in view is exported To change the workbook to which the values are expo
22. hand Measure M Black Hypothenar eminence of the hand Current C Yellow Hyperthenar eminence side of the hand Table 4 1 Skin electrode placement on adults Figure 4 4 Skin electrode placement on adults Version 1 0 ENGLISH EUROPE 9 Med Storm Stress Detector User Manual 4 2 3 Skin electrode placement on premature infants The intended placement of the electrodes is under the foot on premature infants 1 Place the electrodes according to Table 4 2 and Figure 4 5 The distance in between each electrode shall be at least 7 mm 2 Attach the connectors of the electrode cable to the electrodes according to Table in Figure 4 5 color of the ankle Messe MPS Ferske the foot coe Ee tenne of the ankle Table 4 2 Skin electrode placement on premature infants d Figure 4 5 Skin electrode placement on premature infants Version 1 0 ENGLISH EUROPE 10 Med Storm Stress Detector User Manual 4 3 Software and settings No other software than Med Storm approved software shall be installed on the display unit PC The Med Storm application software comes pre installed on systems delivered with the recommended touch screen computer Software is also supplied on a CD The Setup file on the CD automatically installs the software on computers running Windows XP or Vista For detailed computer requirements please refer to Appendix B of this manual Areas outlined in red in the figures are areas on the screen that have to
23. he communication port down pointing arrow and select the desired port The default communication port is set to COM 1 To choose data path for data recording select Choose data path and browse the desired path The default data path is set to C Medstorm To set the refresh time touch the refresh time area and set the desired refresh time The recommended refresh time is Is Data path If the box Popup keyboard is chosen the cIYmedstorm system is set to show an on screen keyboard when needed in the application Pu recommended when using touch screen ot Under the heading Analysis the settings Popup keyboard for Bad signal limit Bad signal limit 2 and EDR amplitude limit can be changed by selecting each area The Bad signal limit default settings for these values are the values shown in Figure 4 28 All signal limit values are reset to their default values when starting the program If a setting 1s changed the user is asked to confirm Press Ok to confirm the changed settings or Cancel to leave the settings unchanged Analysis Bad signal limit EDR amplitude limit 0 i 02 Figure 4 28 Configuration Version 1 0 ENGLISH EUROPE 2 Med Storm Stress Detector Analyze recorded session To load a session recorded earlier use the Load patient button on the screen A window will appear on top of the Stress Detector program window where available patient measurements can b
24. mer or the user of the Stress Detector should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic 6 kV contact 6 kV contact discharge ESD 8 kV air 8 kV air IEC 61000 4 2 Electrical fast 2 kV for power supply 2 kV for power transient Burst lines supply lines IEC 61000 4 4 I kV for input output I kV for lines input output lines Surge I kV differential mode I kV differential IEC 61000 4 5 2 kV common mode mode 2 kV common mode Voltage dips short lt 5 Ur lt 5 Ur interruptions and gt 95 dip in Ur gt 95 dip in Ur voltage variations on for 0 5 cycle for 0 5 cycle power supply input lines 40 UT 40 UT IEC 61000 4 11 60 dip in UT 60 dip in UT for 5 cycles for 5 cycles 70 UT 70 UT 30 dip in UT 30 dip in UT for 25 cycles for 25 cycles lt 5 UT lt 5 UT gt 95 dip in UT gt 95 dip in UT for 5 sec for 5 sec Power frequency 50 60 Hz magnetic field IEC 61000 4 8 NOTE Uris the a c mains voltage prior to application of the test level Table D 2 Electromagnetic immunity 202 Version 1 0 ENGLISH EUROPE 32 Med Storm Stress Detector User Manual Guidance and manufacturer s declaration electromagnetic immunity The Stress Detector is intended for use in the electromagnetic environment specified below
25. n the lowest microsiemens levels at the y axis where the registration curve was observed in the analyzing window correlate directly to how forceful the skin sympathetic nerves are firing This is illustrated in Figure 4 16 0000 6 0000 FNS FN a 5 0000 i GSR AC fy Skin conductance PE Te pe 4 0000 E ee 3 0000 BP 2 0000 l 1 0000 f 5 i vn Oa E 0 0000 4 5 ET EE E E EN A k gaas ut i E n ap i EE GSR MAC a i l a 4 4 0000 Int nerv Microneurographi sympathetic 2 0000 bail O sec 160 sec Figure 4 16 Correlation between the firing rate in the skin sympathetic nerves and the number of skin conductance peaks Moreover small bursts in the sympathetic nerves give small skin conductance peaks and huge bursts in the sympathetic nerves give huge skin conductance peaks Version 1 0 ENGLISH EUROPE 15 Med Storm Stress Detector User Manual One skin conductance peak is defined as a minimum followed by a maximum in conductance values In the detailed graph the minimum of one peak is marked with a blue square and the maximum with a red square From the skin conductance peaks number of measures can be calculated The measures are calculated within the time window shown by the detailed graph typically 15 seconds Peaks per second Hertz Hz This is the number of peaks in the window divided by the time span of the window Average Peak micro Siemens uS The difference in conductan
26. ond changes colour when the behavioural state changes Prechtl s Five Point Scale When the preterm infant is calm and moving Eyes closed regular respiration a little the background colour is white or RE l light yellow As the preterm infant starts to E be fuzzy v ae vom re to a Eyes closed irregular respiration orange and eventually turns to red when the ADEE l ay sg small movements infant is crying or IS 1n significant stress 3 L Eyes open no movements The Area under curve is for research Le Eyes open gross movements purpose 5 f Crying vocalisation Table 4 3 Prechtl s Five Point Scale gt Storm H Skin conductance and the stress response from heel stick in preterm infants Arch Dis Child Fetal Neonatal ed 2000 83 143 147 Version 1 0 ENGLISH EUROPE 20 Med Storm Stress Detector Analysis Research Depending on if the Stress Detector application is used online or offline the title displayed is Research or Analysis The measurement values shown are in both User Manual cases e Area huge peaks e Area small peaks e Peaks sec e Average Peak aiql Hipiai e Average Rise Time z e Signal Quality Figure 4 24 Research mode 4 3 5 Features in Stress Detector Time scale Adjust the time scale by using the three snare buttons in the lower right corner 000 000 22 Zoom in Zoom out Auto fit time scale to 15 s zoom aa Figure 4 25 Features in Stress Detec
27. ply The PC power supply unit Figure 3 6 has a cable connecting to the computer The connector for the mains cable 1 is on the opposite side Figure 3 6 PC power supply unit 3 3 2 PC stand A table stand can be used to operate and work comfortably with the system The mounting mechanism of the stand has to be VESA 75 compatible 3 3 3 Power supply holder Rubber rings are used to attach the measuring unit power supply and the PC power supply to the holder at the back of the computer 3 3 4 Stress Detector application software The Stress Detector application software allows the user to view and analyze a graph of the conductance in real time It also allows the user to record the measurements for analysis at a later time The software is operated by using the touch screen recommended or an external keyboard and mouse 3 4 Electrode cable There are two different electrode cables One is used for adult patients Figure 3 7 and the other for premature infants The electrode cable has one connector for the MU 1 and three connectors for the electrodes 2 Se Figure 3 7 1 2 3 5 Electrodes Figure 3 7 Electrode cable Different electrodes are used for adult patients and premature infants Use only electrodes approved by Med Storm my I me v gt Figure 3 8 Electrodes for adult patients ON Version 1 0 ENGLISH EUROPE Med Storm Stress Detector User Manual 4 Operating Instructions
28. proaches 10 max index value the noxious stimuli discomfort is so forceful so the patient is about awakening and may need more hypnotics as well If the Area under curve approaches 10 and peaks per second 1s 0 the width of the peak is more than the analyzing window 15 sec and the patient is about waking up The rise time and the mean amplitude of the peaks with grey background are for research purpose Storm H Myre K Rostrup M Stokland O Reeder J Skin conductance correlates with perioperative stress Acta Anesthesiol Scand 2002 46 887 895 Storm H Shafiei M Myre K Reeder J Palmar skin conductance compared to a developed stress score and to noxious and awakeness stimuli on patients in anaesthesia to study the sensitivity and specificity of skin conductance Acta Anaesthesiology Scand 2005 49 6 798 804 Version 1 0 ENGLISH EUROPE 18 Med Storm Stress Detector User Manual Post operative In Post operative application mode the _ measurement values shown are a e Peaks sec e Average Peak e Signal Quality ae PODPRE Figure 4 21 Post Operative mode The peaks per second measure number fluctuations of skin conductance NFSC shows the rate of firing in the sympathetic nerves This index is valuable to monitor postoperative pain and can be used on patients in the intensive care unit as well The index changes background colour according to the NRS or VAS score in figure 4 22 The index may al
29. quirements in IEC 60601 1 1 e The PC must be IEC 60601 1 graded if used within the patient environment e The PC must be IEC 60950 or similar graded if used outside the patient environment It should always be grounded protective earth in the same room as the patient if the PC should be outside the room of the patient Table B 2 Version 1 0 ENGLISH EUROPE 28 Med Storm Stress Detector User Manual Mechanical dimensions Weight kg Stress Detector 0 37 210x113x41 Measuring unit incl On Off button and rubber feet 348 x 287 x 92 Table B 3 Weight and dimensions List of cables and maximum lengths of cables OE Model or part Electrode cable Med Storm 2010 adult Innovation AS Electrode cable Med Storm 2011 infant Innovation AS smp ee cable Innovation AS Mains cable PC 2 11600 gt Mains cable MU 2 1 2000 gt Table B 4 Cable lenghts The table of cable lengths also represents the list of cables and transducers sold by the manufacturer as replacement parts for internal components Alternative mains cables might be used but a mains cable that complies with the requirements in IEC60601 1 and any national deviations must be used when installing the Stress Detector Version 1 0 ENGLISH EUROPE 2 Med Storm Stress Detector User Manual Appendix C Safety Standards and regulations The Stress Detector meets the requirements of the following safety standards and regulations Standard
30. r 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 Stress Detector is used exceeds the applicable RF compliance level above the Stress Detector should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Stress Detector gt Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Table D 3 Electromagnetic immunity 204 Version 1 0 ENGLISH EUROPE 33 Med Storm Stress Detector User Manual Recommended separation distances between portable and mobile RF communications equipment and the Stress Detector The Stress Detector delivery system is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Stress Detector can help prevent electromagnetic interferance by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Stress Detector as recommended below according to the maximum output power of the communications equipment Rated maximum output power of Separation distance according to frequency of transmitter transmitter m 0 12 0 12 0 23 0 38 0 78 1
31. r with the Measuring Unit is of medical grade Do not use any other than the recommended power supply unit PDM60US24 unless it has been tested and verified by Med Storm that it works together with the Measuring Unit 1 The power supply unit Figure 3 3 has a cable which connects to the Measuring Unit On the opposite side is a connector for the mains cable 1 Figure 3 3 Measuring Unit power supply 3 3 Computer The computer recommended by Med Storm is of medical grade with a display screen and PC in the same housing The PC can be manoeuvered using the touch screen or by connecting an external keyboard and mouse USB The connectors and ON OFF button are placed on the rear side of the screen Figure 3 4 Connectors at the rear side of the screen To connect the Med Storm Stress Detector the following connectors and buttons Figure 3 5 are used e power supply inlet 1 e ON OFF button 2 e Communication cable connector 5 p 1 2 3 4 5 Figure 3 5 PC connectors For data transfer or system management the following connectors Figure 3 5 can be used e Network cable connector 3 e 4USB connector 4 for optional connection of Keyboard Mouse and or Memory stick If any other PC than the by Med Storm recommended one is used make sure the system specifications in Appendix B are followed Version 1 0 ENGLISH EUROPE 5 Med Storm Stress Detector User Manual 3 3 1 Power sup
32. rrnnvrnnsernvrrnnsesnvrnnsesnnvrnssesnnrsnssennvnssseenn 25 5 1 EINE soleus lyase ods eartrertictnd nat EE E dnana ube penn dvadanen eae AN A 25 5 2 Preventive maintenance rrrrrrrnrrrrrnnnrrrnrsrrrnnnrnnrrernnnnrnnnsrernnnrnnnsseennnnrnneseen 25 5 3 _ Simplified function ES Bua vever 25 54 SUPPol INIOM MATION icc cceccisscsnnaccosteavsanatavelesgeaassuesdeenenavssaceasdiandstvgnoiacvaneeeavenees 25 So ASIC ANMING EE 25 96 SP NNN 26 Appendix A Environmental and handling conditions rrrrrrrrronnrrrrronnnrrrrnrnnvnnennn 2 Appendix B Technical specifications rrrrrrrnnrrrronnrrrrennrrrrennrrrrnnnvrrrennrrrnsnnvrrrsnnnnene 28 Appendix C Safety Standards and regulations rrrrrrranrrrrnnvrrrnnvrrrnnvrrrnnvrrnnnrrnennne 30 Appendix D Electromagnetic compatibility rrrrrrrrnrrrrrronnvrrrrrnnnrrrrrnnnnrrnrnnnnnvnnnnr 31 Appendix E Protection against data virus rrrrnrrrrrornvrrrrnrnnrrrnrrnnnrrrrrrnnnrrnrnnnnnrnennn 35 Appendix F Pre use CNECKIIS Lunn rvv ssnanepddeaeirkudenuenvne 36 i Version 1 0 ENGLISH EUROPE Med Storm Stress Detector User Manual Version 1 0 ENGLISH EUROPE Med Storm Stress Detector User Manual 1 Introduction The manual corresponds to hardware of series C or higher and software of version 1 0 or higher 1 1 Definitions SCMS Skin Conductance Monitoring System Stress Detector Skin conductance Measuring Unit NRS Numerical Rating Scale VAS
33. rted the current workbook must be closed A new workbook will then be created at the next export The data saved by the Export button is limited to a maximum of eight minutes 4 3 6 Data transfer To transfer data from the PC to another PC connect a USB memory stick to one of the USB connectors in the Computer Se Figure 3 5 Touch the Start button and chose My Computer Browse and choose the files which are to be transferred 4 4 Error conditions The Stress Detector measures very small changes in electrodermal response and 1s extremely sensitive Simultaneous use of electro surgery will for example disturb the measurements made with the Stress Detector fen xx wan rang pr If any interference occurs the system will automatically recognize the interference and indicate this by a red warning text Bad signal quality The graph window will also turn yellow for the duration of the 75 interference to indicate that the recorded signal is not reliable See Figure 4 31 If the measuring unit looses contact with the S OL IENE M electrode the error state will be indicated by a red warning text Electrode error and with a brown background in the graph Figure 4 31 Interference warning Par ID Alan hindi If the measuring unit looses contact with the lt tnter patient D gt Anaesthesia J operator PC the error state will be indicated 0 00 o 00 oo ooo _ by a red warning text
34. sducers and cables other than those specified may result in increased emission or decreased immunity of the system The Stress detector from Med Storm consists of Measurement equipment in Sketch Part Mains cable for power supply MU European 16 12000 Operator station station Operator station in sketch Part Power supply holder with rubber rings and cable not in sketch 5001 corector band PC 17 6001 T supply unit with power cable 8 16002 Mains cable for power supply PC European 9 16003 PC table stand 6008 Accessories in sketch Part Mains cable for power supply MU American 16 12002 Mains cable for power supply PC American 19 16004 Version 1 0 ENGLISH EUROPE 3 Med Storm Stress Detector User Manual 6 Mains cable for 7 Display PC MU power supply 3 Com cable 4 Power supply MU 1 Measuring Unit MU stand 8 Power supply PC p 9 Mains cable for PC 2 Electrode cable power supply Figure 3 1 System overview sketch 3 2 Measuring Unit MU The measuring unit Figure 3 2 has three connectors and one power ON OFF button The electrode cable connector 4 1s placed on one side The power supply inlet 1 ON OFF button 2 and communication connector 3 are found at the opposite side 1 2 3 Figure 3 2 Measuring Unit Version 1 0 ENGLISH EUROPE 4 Med Storm Stress Detector User Manual 3 2 1 Power supply The power supply unit used togethe
35. so be influenced from other sympathetic nerve stimulation like nausea vomiting and anxiety When there is no pain or discomfort the colour is white or light yellow During discomfort the index changes from yellow to orange to red as the pain or discomfort 4 increases The mean amplitude of the peaks with grey background is for research purpose 0 5 0 45 0 4 0 35 0 3 1 0 25 0 2 0 15 0 1 0 05 0 INRSO I NRS 1 3 NRS 4 5 NRS 6 10 NFSC Figure 4 22 Level of pain Ledowski T Bromilow J Wu J Paech J Storm H Schug A The assessment of postoperative pain by monitoring skin conductance results of a prospective study Anaesthesia 2007 62 989 993 Gjerstad AC Wagner K Henrichsen T Storm H Skin conductance as a measure of discomfort in artifical ventilated children submitted for publication Refr Ledowski T Bromilow J Wu J Paech MJ Storm H Schug SA Version 1 0 ENGLISH EUROPE 19 Med Storm Stress Detector User Manual Pre term In the Pre term application mode the measurement values shown are e Peaks sec e Area under curve e Signal Quality AA See Sea PE gt 7 TA ES nie xx Figure 4 23 Pre term mode The peaks per second measure shows the rate of firing in the sympathetic nerves It increases when the behavioural state increases The behavioural state can be recorded according to Prechtl s Five Point Scale se Table 4 3 The index peaks per sec
36. the key in the power connector Version 1 0 ENGLISH EUROPE 7 Med Storm Stress Detector User Manual 5 Connect the electrode cable to the MU The cable connector has a peg marked with two arrows to be aligned with the groove in the MU connector Note To disconnect the electrode cable pull straight out Do not twist the connector 6 Attach both power supply units to the holder at the back of the computer using the rubber rings Use the two smaller rings to attach the MU Power supply to the holder and the two larger rings to attach the PC power supply to the holder Slip one of the large rubber rings over the PC power supply unit Place it towards the end opposite the fixed power cable Place the PC power supply unit in the holder with the mains cable connector pointing down Slip the other large rubber ring over both the power supply unit and the metal holder from the lower end until it fits in the fixing position Roll the upper attaching ring to the top of the holder and then down until it fits in the fixing position 7 Slip one of the small rubber rings over the MU power supply unit Place it towards the end opposite the fixed power cable Place the MU power supply unit in the holder with the mains cable connector pointing down Slip the other small rubber ring over both the power supply unit and the metal holder from the lower end until it fits in the fixing position Roll the upper rubber ring to the top of the holder and then
37. tor Mark event To mark events of interest during a measuring session press the button in the right lower corner The event will be marked in the graph as a vertical line with a at the top An on screen keyboard will appear on top of the Stress Detector program window to allow writing a comment corresponding to the event in the Enter comment area If a comment is written to a marked event the will automatically change into a C for Comment When analyzing the recorded data the comment can be read if pointing at the marked event Patient 123 ABC t wap fees gt mage Moe Toe be va 0 00 0 00 aie ooo M aal DIDIER aa Patiant 123 ABC Figure 4 26 Mark event Figure 4 27 Enter comment Version 1 0 ENGLISH EUROPE 21 Med Storm Stress Detector User Manual Scrolling To look in detail on a specific measurement time period you can use the scroll bar together with the time scale buttons When you offset your viewpoint from the latest measurement vales the automatic scrolling will stop To restart automatic scrolling press the rightmost button on the scroll bar Configuration To change settings for the program touch the Configure button A window will TE esia e appear on top of the Stress Detector emnene COM ooo ooo ay program window where changes to the settings can be made rita et naesthesia Di dam Ohoces pat cimeaedstorm To select communication port touch t
38. uch the Go online button To start a new session start again from number 4 Version 1 0 ENGLISH EUROPE User Manual BP Figure 4 13 End and store session irib mee ae naesthesii ma m a ple a iigh lt gt 0 00 0 00 encore r PIPARI inte i i w i 3093 1 pa TPAR Figure 4 14 Go online after ending session 14 Med Storm Stress Detector User Manual 4 3 3 Calculated measurement values Skin conductance is a measure of how easily electric current will travel through the skin based on the humidity of the skin The Stress Detector system is measured in micro Siemens uS The physiological process is shown in Figure 4 15 Beco Gott urter Lite eal Ted pe Figure 4 15 Physiological process which the Stress Detector measures The skin conductance is to a large extent determined by the number and activity of sweat glands Sweat glands are controlled by the sympathetic nervous system When the skin sympathetic nervous system is firing sweat is released within 1 2 sec and the conductance increase When the sweat is reabsorbed the conductance decreases This process creates one skin conductance peak The number of skin conductance peaks correlates directly to the firing rate in the skin sympathetic nerves Moreover the amplitude of the peaks and the relatively area below the curve accumulated difference between the conductance values at the registration curve when they are larger tha
39. y that if you temporarily disconnect any of the electrodes from the measuring unit you get an error reporting electrode error or Bad signal quality Verify that you have a secondary monitor for stress indications such as e g blood pressure measurement For reasons of safety the device may only be used if all of the requirements above are satisfied Version 1 0 ENGLISH EUROPE 36
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