Med-Storm Pain Monitor™ User manual - Med
Contents
1. ss 35 Appendix G Physiological and clinical function of the Skin Conductance Monitor EEE EEE SE 36 Version 1 0 Englsih Page 3 Med Storm Pain Montior 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 Skin ConductanceAlgesimeter Pain Monitor Skin conductance Measuring Unit NRS Numerical Rating Scale Visual Analog Scale NFSC Number Fluctuations of Skin Conductance 1 2 Intended use The Pain Monitor is intended to determine a patient s sensitivity to pain 1 3 Normal use Normal use is 24 hours day 200 days a year The electrodes do not allow continuously use for more than 48 hours after 48 hours they have to be changed 1 4 Intended user Only trained physicians or nurses shall use the system 1 5 Indications for use Indications for use are for e patients undergoing anaesthesia e postoperative patients e patients in the intensive care units e infants from 25 weeks of gestational age 1 6 Contraindications for use e The device shall not be used at 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 th2. MED STORM shall not be liable for errors contained herein or for inciden tal or consequential damages in connection with the furnishing perform ance or use of this material DISCLAIMER THE MED STORM PAIN MONITOR IS NOT A SUBSTITUTE FOR YOUR PROFESSIONAL JUDGMENT MED STORM SHALL NOT BE LIABLE IN ANY MANNER WHATSOEVER FOR THE RESULTS OB TAINED THROUGH THE USE OF THE PAIN MONITOR PERSONS USING THE PAIN MONITOR ARE RESPONSIBLE FOR THE SUPER VISION MANAGEMENT AND CONTROL OF THE PAIN MONITOR Tapez un texte Page 2 Med Storm Pain Monitor User Manual TABLE OF CONTENTS TAT RO GIDC TIO EEE EN 4 el PANG 4 2 MN to eee ee cee 4 LE NVA 4 14 Mendea DEE de 4 AE TEN 4 1 6 Contraindications for USE 4 1 7 Pre use checks mrr rrrrrs rrrrmssvrrersnrrrrorrnnrrrronsnrersonnnnrnssnnnnnnnsennnnsnnsannnnsne 4 VM 5 21 Electrical shock NAZALNG veke 5 2 2 Environmental conditions rrrnvrrrrrrnnvrrrrnnnnvrrnrnnnnrrrrrnnnnrrnrnnnnvrnnnnnnnnnnnnnnnnvnsnnn 5 2 3 Warning and information symbols 5 3 Technical overview Technical manual 6 3 1 System OE EN EE 6 3 2 Measuring Unit MU 7 POT NN 8 39 7014 000 EE EE eee 8 PT NN ee E E ee en eee 9 PN hr 9 399 POWGrSUDDIY NO vaser eder 9 3 3 4 Pain Monitor application software 9 3 4 Electrode cable ae a ee D ee an 9 ECS EE 9 4 Operating Instructions ii 10 4 1 Instrument SQUID ssostni ioneina sit nor
3. 40000 an 3 0000 BP 20000 1 0000 ri 00000 Lee nen ae nn EEA y ee AR EE ln GSR MAC 5 5 f QU i 1 0000 Int nerv Microneurographi sympathetic nerve 2 0000 O sec 160 sec Figure G 2 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 conduc tance peaks and huge bursts in the sympathetic nerves give huge skin conductance peaks Version 1 0 English Page 36
4. be set Figure 4 31 Export data 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 Version 1 0 English Page 22 Med Storm Pain Montior User Manual The timeframe can be changed either by using the zoom buttons or by changing 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 When the button Export Measurements is selected the user will be able to insert a 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
5. exported To change the workbook to which the values are exported 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 one limit in excel of maximum data points accepted 4 3 5 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 Pain Monitor measures very small changes in skin conductance and is extremely sensitive Simultaneous use of electro surgery will for example disturb the measurements made with the Pain Monitor Patent 123480 a 0 70 0 27 mm If any interference occurs the system will automatically recognize the interference and indicate this by a red warning text Bad sig nal quality The graph window will also turn yellow for the duration of the interfer 7 ence to indicate that the recorded signal 1s not reliable See Figure 4 32 ae PODER If the measuring unit looses contact with the 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 32 Interference warning If the measuring unit looses contact with the operator PC fig 4 33 the e
6. in Pain Monitor pr F CE bi n faa Version 1 0 English Page 20 Med Storm Pain Montior Mark event User Manual To mark events of interest during a measuring session press the button in the left lower corner fig 4 27 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 Pain Monitor program window to allow writing a comment corresponding to the event in the Enter comment area Fig ure 28 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 rws owas fue gt 0 00 0 00 ala i DIDIER Figure 4 27 Mark event Scrolling To look in detail on a specific meas urement time period you can use the scroll bar together with the time scale buttons When you offset your viewpoint from the latest measure ment values 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 appear on top of the Pain Monitor program window where changes to the settings can be made Fig 4 29 To select communication port touch the communication port down point ing arrow and select the desired port The default communication p
7. with a pa tient with skin condition which may affect skin conduc tance e g injury of the skin Verify that the system is not going to be used with a pa tient 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 Verify that the system is not going to be used more than 48 hours in row on the same patient due to the electrodes that have to be changed Verify that the electrodes are placed according to this manual Ch 4 2 2 for adults Ch 4 2 3 for premature infants Verify that the electrodes are of the correct type and ap proved by Med Storm Verify that 1f you temporarily disconnect any of the elec trodes from the measuring unit you get an error reporting electrode error or Bad signal quality Verify that you have a secondary monitor to determine the patient s sensitivity to pain 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 Page 35 Med Storm Pain Montior User Manual Appendix G Physiological and clinical function of the Skin Conductance Monitor 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 Sieme
8. 1 Med Storm Pain Montior User Manual If the measuring electrode is fastened to the extremity with regional block no response to pain noxious stimuli will be observed because the skin sympathetic nerves are blocked Artefacts can also be seen if the electrodes are attached to injured skin Artefacts have been seen in the registration during tetanic stimuli if 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 hand Measure M Black Hypothenar eminence of the hand Current C Yellow Hyperthenar of the hand Table 4 1 Skin electrode placement on adults Figure 4 4 Skin electrode placement on adults Version 1 0 English Page 12 Med Storm Pain Montior User Manual 4 2 3 Skin electrode placement on infants The intended placement of the electrodes is under the foot on infants 1 Place the electrodes according to Table 4 2 and Figure 4 5 The di
9. IEC60601 1 Do not dispose of this unit It should be returned to Med Storm Innova tion for proper material reuse or recycling Table 2 1 Warning and information symbols Version 1 0 English Page 5 Med Storm Pain Montior User Manual 3 Technical overview Technical manual 3 1 System overview The Pain Monitor is an electronic conductance meter for detecting skin conductance changes on palmar and plantar skin sites to determine a patient s sensitivity to pain Note The use of accessories transducers and cables other than those specified may result in increased emission or decreased immunity of the system The Pain Monitor from Med Storm consists of Measurement equipment in sketch Part Mains cable for power supply MU European 16 12000 Short manuals infants postoperative and intensive not in sketch 4002 care and anaesthesia Operator station in sketch Power supply unit with power cable 18 6002 Mains cable for power supply PC European 19 6008 Accessories in sketch Part Mains cable for power supply MU American 16 12002 Mains cable for power supply PC American 19 6004 Power supply holder with rubber rings and cable not in sketch 5001 collector band Version 1 0 English Page 6 Med Storm Pain Montior User Manual 6 Mains cable for 7 Display PC MU power supply 3 Com cable i 4 Power supply MU 1 Measuring Unit MU stand 8 Power supp
10. Med Storm Pain Monitor User Manual Med Storm Pain Monitor User manual VERSION 1 0 ENGLISH MA001 25 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 Tapez un texte Page 1 Med Storm Pain Monitor User Manual IMPORTANT The user manual covers the operation of the MED STORM Pain Monitor Read all instructions warnings and precautions prior to use Only a trained physician or nurse should use the system Users of the equipment must be familiar with the medical aspects of the conditions for which the MED STORM Pain Monitor is used MED STORM considers itself responsible for any effects on safety reliabil ity and performance of the equipment only 1f 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 1s 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 fitness for a particular purpose
11. SD Ambient temperature Ambient pressure Ambient humidity Ambient temperature Ambient pressure Ambient humidity Ambient temperature Ambient pressure Ambient humidity IP X0 10 C 30 C 50 F 700hPa 1060hPa 10 2 PSI 15 4 PSI 30 75 10 C 70 C 500hPa 1060hPa 7 3 PSI 15 4 PSI 10 90 10 C 30 C 50 F 700hPa 1060hPa 10 2 PSI 15 4 PSI 30 75 86 F 86 F It is possible to transport the system worldwide by air road ship and train It 1s possible to transport the system worldwide by air road ship and train The Pain Monitor meets requirements in accordance with IEC 60601 1 2 Electromagnetic compatibility The device complies with Part 15 of the FCC Rules Version 1 0 English Page 26 Med Storm Pain Montior User Manual Appendix B Technical specifications Measurements ac Noise level 1 o below 0 002 LS curacy This applies for resistive measurements on 100 uS Measurement range Classification of Class IIA 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 provided power supply unit unless it has been tested and verified by Med Storm that it works
12. 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 Ifconsidered 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 Pain Monitor application software functionality It may slow down the computer while inspecting files for virus or it may affect the Pain Monitor application software when removing a detected virus New data viruses appear and thus the virus software needs to be updated This update procedure may also affect the Pain Monitor application software functionality temporarily or permanently To avoid potential hazards associated with the management of virus protection software the following rules shall be followed 1 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 Page 34 Med Storm Pain Montior User Manual Appendix F Pre use checklist Check Signature Verify that the system is not going to be used
13. by monitoring skin conductance results of a prospective study Anaesthesia 2007 62 989 993 Version 1 0 English Page 18 Med Storm Pain Montior User Manual 0 00 0 07 peaks per sec LIGHT YELLOW 0 13 0 21 peaks No pain or VAS 1 3 er sec Patient is possible in pain VAS 6 8 go and evaluate the situation The patient is probably in pain VAS 8 10 go and find out how to help the patient Figure 4 22 Infants In the Infant application mode the measurement values shown are fig 4 23 e Peaks sec dl 4 PIPA Figure 4 183 Pre term mode The peaks per second index shows the rate of firing in the sympathetic nerves It in creases when the behavioural state increases The behavioural state can be recorded ac cording to Prechtl s Five Point Scale se Table 4 The index peaks per second changes colour when the behavioural state changes and then it is possible to determine the patient s sensitivity to pain When the infant is calm and moving a little Prechtl s scale 1 2 3 the peaks per sec are less than 0 21 peaks per sec the background colour is white or light yellow yellow As the infant starts to be ac tive fuzzy Prechtl s scale 4 the peaks per sec are 0 21 peaks per sec or more but less than 0 33 peaks per sec the index is yellow Eventually when the infant is crying or is in significant pain Prechtl scale 4 5 then the peaks per sec are more or lik
14. e 0 33 and the index turns from orange to red figure 4 24 The analyzing window should be 15 sec and the refresh time each sec Version 1 0 English Page 19 Med Storm Pain Montior User Manual Prechtl s Five Point Scale Eyes closed regular respiration no movements Eyes closed irregular respiration small move ments Eyes qpen no movements Eyes Open gross movements Crying vocalisation Prechtl s Five Point Scale WHITE 0 00 0 07 peaks per sec The infant is calm LIGHT YELLOW 0 14 peaks The infant is calm and move a little per sec The infant is active observe the infant pain dis comfort threshold is reached The infant is probably in pain discomfort evaluate the situation The infant is in increasing pain discomfort Figure 4 24 Analysis Research Depending on if the Pain Monitor applica tion is used online or offline the title dis played is Research or Analysis The measurement values shown are in both cases Fig 4 25 e Area huge peaks e Area small peaks The hugest of these areas are also seen zE E ar e Peaks sec s TIE e Average Peak e Average Rise Time Figure 4 25 Research mode e Signal Quality 4 3 4 Features in Pain Monitor Time scale Adjust the time scale by using the three but rom tons in the lower right corner Fig 4 26 000 000 C OS EEE Q Zoom in Zoom out Auto fit time scale to 15 s zoom Figure 4 196 Features
15. e E n E ner teen tien 10 4 2 Skin electrode placement ss 11 21 UN 11 4 2 2 Skin electrode placement on adults rrrrrrnnrrrrrnnrrrronnrrnrrnnrrrrrnnrnnnnnnnne 12 4 2 3 Skin electrode placement on infants rrrrrrrnnrrnrrrnnnrrnrrrnnrrnrrrrnvrnnrennn 13 43 Software and SCUUINGS socsicseticesscducsuiecvaivsvinsasardaniebsencadancdeawdabnencetebeasartitiseloneuns 13 4 3 1 Stress Detector user interface overview 14 152 FT 15 Calculated measurement values rrrrrrrrrrnnrrrnnnvrrrnrnnrrrnrnvrnrnnnvrnrnnnnrnsnnnnrnnnnnnnennn 17 4 3 3 Choose application mode rrnrrrrrrrnvrrnrrrnnrrrnrernnrrnrrrnnnrnnsernvrnnnrennvrnnsennn 17 4 3 4 EOAUCS IN PAIN MONO ee sd 20 4 3 5 Data TrANSTOL cessduceasnnsecavnnhinsdavieenededersbnnssubisheenteshinoaniansededuaceanastadvaniasdiveass 23 2 ECC CO OO ne tree ne eee eee eee arene 23 5 Care and maintenance Lavvo een 24 EE EEE eee 24 5 2 Preventive maintenance 24 55 SMET TANNER 24 D SUDO OM NNN 24 55 Cleaning is 24 Seo SaO 1100 6111019 a nn ne 25 Appendix Environmental and handling conditions 26 Appendix B Technical specifications rrrrrrrnnrrrronnrrrrennvrrrrnnvrrrnnnvrrrennvrrnrnnrnrrennnnene 2 Appendix C Safety Standards and regulations rrrrrrnrrrronvrnrnnvrrrnnvrrrnnvrnnnvrnnnnnne 29 Appendix D Electromagnetic compatibility 30 Appendix E Protection against data virus 34 Appendix F Pre use checklist
16. e patient has an injury affecting the sympa thetic 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 Page 4 Med Storm Pain Montior User Manual 2 Warnings Read the entire operating manual before operating this Pain Monitor It is the responsibility of the user to ensure that any applicable regulations regarding the installation and operation of the Pain Monitor are observed The Pain Monitor 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 Pain Monitor 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 Pain Monitor as warning and information sym bols Warning symbol Read the entire operating manual before operating this Pain Monitor Information symbols The parts applied to the patient are insulated from the box and mains according to body floating BF model described in
17. eters m Field strengths from fixed RF transmitters as deter mined 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 800MHz 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 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 Pain Monitor is used ex ceeds the applicable RF compliance level above the Pain Monitor should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Pain Monitor 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 Recommended separation distances between portable and mobile RF communications equipment and the Version 1 0 English Page 32 Med Storm Pain Mont
18. ferent 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 can be used for adult patients and premature infants after tested and recommended by Med Storm r Med Storm recommends that electrodes from Med Storm are used Figure 3 8 Electrodes for adult patients Version 1 0 English Page 9 Med Storm Pain Montior User Manual 4 Operating Instructions The following instructions describe all necessary steps required to set up and operate the Pain Monitor 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 bellow the electrodes or when the pa tient has an injury affecting the sympathetic skin nerves Moreover local nerve blocks at the measuring area will affect the method 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 electri cal equipment 4 1 Instrument setup When assembling
19. fig 4 17 The different modes affect which meas urement values are displayed above the graph windows Figure 4 17 Choose application mode aii m DIR GJE During anaesthesia In the Anaesthesia application mode the measurement values shown are fig 4 18 e Peaks sec e Area under curve aa i p Se r 17 Figure 4 17Anaesthesia mode If the Peaks per sec measure is 0 the patient is sufficiently or too much sedated If there are peaks 2 or more in the analysing window of 15 sec there are bursts in the sympa thetic nerves and the patient s sensitivity to pain is reached during anaesthesia the colour coded peaks per sec is yellow and may turn into red the patient needs more analgesics fig 4 18 If the area under the curve increases to 10 the patient is about waking up from the stimulus When the area under the curve turns to blue the patients need more anal gesics and hypnotics forceful bursts in the sympathetic nerves when the patient is about waking up fig 4 19 the preset refresh time of one sec is recommended WHITE 0 00 0 07 peaks per sec LIGHT YELLOW 0 14 peaks per sec Figure 4 18 WHITE 0 0 2 0 BLUE 5 0 10 0 Figure 4 19 Post operative Version 1 0 English Page 17 Med Storm Pain Montior User Manual In Post operative application mode the measurement values shown are fig 4 20 e Peaks sec dl PIa Figure 4 20 Post Operati
20. gistration curve and the established baseline when they are larger than the baseline This is illustrated in Figure 4 15 Version 1 0 English Page 17 Med Storm Pain Montior User Manual ne DIET ST ee s SS tt TE SSH gt Rt COC ASH dd 55 sec CS DE ee ee Area huge peaks 1 co o i on Microsiemens 14 12 5 12 0 115 gt p 15 sec 10 5 10 0 3 5 0 I 99SEC Figure 4 15 Calculation of area huge peaks Version 1 0 English Page 15 Med Storm Pain Montior User Manual Area small peaks micro Siemens seconds uSs 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 16 Microsiemens 10 5 Area small peaks 10 4 10 3 10 2 10 1 10 0 3 0 15 sec 55 sec Microsiemens 125 _ Area small peaks 12 0 11 5 11 0 10 5 10 0 3 0 55sec Figure 4 16 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 t
21. hen 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 col our There are two ways signal quality is measured for each the warning limit giving yel low 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 interference 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 Page 16 Med Storm Pain Montior User Manual 4 3 3 Choose application mode Choose between different application 000 000 modes by touching anywhere in the Ap plication Mode field and then mark one of the modes
22. ior User Manual The Pain Monitor delivery system is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Pain Monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Pain Monitor 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 W 150 KHZ to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 0 l 3 For transmitters rated at maximum output power not listed above the recommended separation distance d in me ters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maxi mum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 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 Page 33 Med Storm Pain Montior User Manual Appendix E Protection against data virus Data virus is a threat to the functionality of the Pain Monitor PC
23. ixed 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 point ing 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 rub ber ring to the top of the holder and then 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 Note To disconnect pull out each electrode connector separately Do not pull on the electrode cable itself maximum time of 48 hours Figure 4 2 Correct way of disconnecting the electrodes 4 2 1 Artefacts Artefacts can be seen when moving the hand foot where the electrodes are attached or by pulling at an electrode If the Measuring electrode is wrapped the movement artefacts should be improved eliminated Version 1 0 English Page 1
24. l 9 To start measuring again touch the Fe m a ME _ Go online button To start a new 9 00 0 00 p none session start again from number 4 r n i NC IK Figure 4 14 Go online after ending session Calculated measurement values One skin conductance peak is defined as a minimum followed by a maximum in conduc tance values In the detailed graph the minimum of one peak is marked with a blue square and the maximum with a red square Appendix G Physiological and clinical function of the Skin Conductance Monitor 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 sec onds The refresh rate is each sec 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 conductance 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 1s the rate of increase or decrease from the start to the end of the measurement window Area huge peaks micro Siemens seconds uSs This measure is calculated by establishing a horizontal base line from the first peak minimum in the time window The area that is calculated is the accumulated difference between the conductance values at the re
25. ly PC po 9 Mains cable for PC ee module 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 is 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 Page 7 Med Storm Pain Montior User Manual 3 2 1 Power supply Figure 3 3 Measuring Unit power supply The power supply unit used together with the Measuring Unit is of medical grade Do not use any other than the recommended power supply unit unless it has been tested and verified by Med Storm that it works together with the Measuring Unit The power supply unit Figure 3 3 has a cable which connects to the Measuring Unit On the opposite side is a stick for power 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 manoeuvred using the touch screen or by con necting 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 Pain Monitor the following connectors and buttons Figure 3 5 are used e power supply inlet I e ON OFF button 2 e Communication cable con
26. nector 5 a a aja 2 pr ae E a nn em a a pabdbbdr J 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 4 USB connector 4 for optional connection of Keyboard Mouse and or Memory stick Version 1 0 English Page 8 Med Storm Pain Montior User Manual If any other PC than the by Med Storm recommended one is used make sure the system specifications in Appendix B are followed 3 3 1 Power supply 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 mount ing mechanism of the stand has to be VESA 75 compatible 3 3 3 Power supply holder Rubber rings can be 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 Pain Monitor application software The Pain Monitor 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 key board and mouse 3 4 Electrode cable There are two dif
27. ns uS The physiological process is shown in Figure G 2 Bec Gott urter Lite eel rd pate Figure G 1 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 Since acetyl cho line acts on the muscarine receptors the skin conductance response is not influenced from changes in blood circulation or medication acting on the blood circulation More over the skin conductance response 1s not influenced from neuro muscular blockers act ing on nicotine receptors When the skin sympathetic nervous system 1s firing sweat 1s 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 ac cumulated difference between the conductance values at the registration curve when they are larger than 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 sympa thetic nerves are firing This is illustrated in Figure G 2 0000 6 0000 af VUS AR D FN 5 0000 Fl GSR AC for em Skin conductance
28. on on the screen Fig 4 30 A window will appear on top of the Pain Monitor program window where avail able patient measurements can be 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 __ i touching the Load patient button an TI DISS other path than the desired are chosen in EF gt settings The files available depend on which Figure 4 30 Load patient data path that has been set Export recorded data aa me To use the Export feature a mouse and Excel Export keyboard must be used Fig 4 31 The Ex a gt ee port feature will work on computers with ar Microsoft Excel and Med Storm software pu JL es 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 com 441 puter with e g a USB memory stick See chapter 4 3 5 On the Excel computer the data can be read with the Load Patient function in the Med Storm software pro gram and then exported to Excel DIBRR Excel Export Start time 2007 11 20 17 06 33 Da ts Auto update w Export analysis EP measurements 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
29. ort is set to COM 1 To choose data path for data re cording select Choose data path and browse the desired path The default data path is set to Figure 4 29 Configure Settings 1 0 0 24 PARI 7 3 Figure 4 208 Enter comment Sorc Mije Anaesthesia horn System Communication port COM1 c medstorm User interface Refresh time s 1 Popup keyboard Analysis Bad signal limit n Bad signal limit 2 EDR amplitude limit 0 02 C Medstorm to set the refresh time touch the refresh time area and set the desired re fresh time The recommended refresh time is 1s Version 1 0 English Page 21 Med Storm Pain Montior User Manual If the box Popup keyboard is chosen the system is set to show an on screen keyboard when needed in the application recommended when using touch screen Under the heading Analysis the settings for Bad signal limit Bad signal limit 2 and EDR amplitude limit can be changed by selecting each area The 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 is changed the user is asked to confirm Press Ok to confirm the changed settings or Cancel to leave the settings unchanged Analyze recorded session To load a session recorded earlier use the Load patient butt
30. ose directly connected to Harmonic emissions Class B the public low voltage power supply net IEC 61000 3 2 work that supplies buildings used for do mestic purposes Voltage fluctuations flicker Complies emissions IEC 61000 3 3 Table D 1 Electromagnetic compatibility 201 The device complies with Part 15 of the FCC Rules Version 1 0 English Page 30 Med Storm Pain Montior User Manual Guidance and manufacturer s declaration electromagnetic immunity The Pain monitor is intended for use in the electromagnetic environment specified below The customer or the user of the Pain Monitor should assure that it is used in such an environment Immunity test Electrostatic dis charge ESD IEC 61000 4 2 Electrical fast tran sient Burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 IEC 60601 test level 6 kV contact 8 kV air 2 KV for power supply lines I KV for input output lines I kV differential mode 2 KV common mode lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5 UT gt 95 dip in UT for 5 sec Compliance level Electromagnetic environment guidance 6 KV contact 8 kV air 2 kV for power su
31. p ply lines I kV for in put output lines I kV differential mode 2 KV common mode lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5 UT gt 95 dip in UT for 5 sec NOTE Uris the a c mains voltage prior to application of the test level Table D 2 Electromagnetic immunity 202 Version 1 0 English Page 31 Med Storm Pain Montior User Manual Guidance and manufacturer s declaration electromagnetic immunity The Pain Monitor is intended for use in the electromagnetic environment specified below The customer or the user of the Pain Monitor 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 Pain Monitor including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3 V d 12 P IEC 61000 4 6 150 kHz to 80 MHz d 12vP 80 MHz to 800 MHz d 273 JP 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 m
32. r user interface overview 1 Patient ID field 9 Event marker 2 Current measurement values 10 Close the Stress Detector Appli 3 Skin conductance graph cation 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 Page 14 Med Storm Pain Montior User Manual 2 The Pain Monitor application software 4 To enter an ID for a patient touch the 4 3 2 Getting started I Turn on the computer using the on off button Se part 3 3 Computer should auto start If not touch the desk top icon SCMS to start the Pain Monitor application software ten pe Perm Aces ard De ms SLM Ss Let Figure 4 7 Start SCMS software mem The Pain Monitor application software Fhe pares ee starts and following window will be 0 00 0 00 gt mms visible on the screen The software starts in a mode that shows measured data without saving it FF v F ft A ti TE dl 4 dere l es Figure 4 8 Pain Monitor software Patient ID box and a keyboard win dow will appear on top of the Pain Monitor software window Write a patient ID by typing on the on screen keyboard When finished touch the on screen keyboard Enter button When the ID is written the data start
33. rror state will be indicated by a red warning text Connection lost to MU and with an orange background in the graph Version 1 0 English Page 23 Pater If Arr hike lt Enter patient ID gt Anaesthesia a p p TM owe under curve u r Fraktion _ Bang Paak ba Ema Ria Tiraka Sipa y Med Storm Pain Montior 0 00 0 00 Fo co NE Connection lost to MU Slur Ceres p D T Using heating mattress GVP Elettronica SCL MED DM WARM 12 commercial mo brand gvp mdl gvp it interference has was been observed at the Skin Conductance or registration curve 2 Figure 4 33 Contact lost warning om pee ea 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 Pain Monitor does not need to be calibrated during specified lifetime years presum ing 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 Inst
34. rument setup 3 Start the Pain Monitor application software according to chapter 4 3 2 Getting Started 4 Verify that a graph is created in the Pain Monitor application software window and that the current measurement values are presented 5 4 Support information Skype Med storm support Tel 47 909 398 10 5 5 Cleaning Always disconnect the Pain Monitor and accessories from its power supply before clean ing After each patient the electrodes used shall be removed and the Pain Monitor and its ac cessories 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 Pain Monitor 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 Version 1 0 English Page 24 Med Storm Pain Montior User Manual Never use ether or petroleum based solvents 5 6 Scrapping instructions All parts of the Pain Monitor 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 Page 25 Med Storm Pain Montior User Manual Appendix A Environmental and handling conditions Measuring Unit Operating Transport Storage Degree of enclosure pro tection Vibration Shock Bump Drop Free fall EMC E
35. s 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 re quirements in IEC60601 1 and any national deviations must be used when installing the Pain Monitor Version 1 0 English Page 28 Med Storm Pain Montior User Manual Appendix C Safety Standards and regulations The Pain Monitor meets the requirements of the following safety standards and regula tions Standard Referred to as IEC 60601 1 1 Safety requirements for medical electrical systems IEC 60601 1 1 UL 60601 1 Medical Electrical Equipment UL 60601 1 The device complies with Part 15 of the FCC Rules Version 1 0 English Page 29 Med Storm Pain Montior User Manual Appendix D Electromagnetic compatibility Guidance and manufacturer s declaration electromagnetic emissions The Pain Monitor is intended for use in the electromagnetic environment specified below The customer or the user of the Pain Monitor should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guid ance RF emissions Group 2 The Pain Monitor must emit electromag CISPR 11 netic energy in order to perform its inter nal function Nearby electronic equipment may be affected RF emissions Class B The Pain Monitor is suitable for use in all CISPR 11 establishments including domestic estab lishments and th
36. s to be saved ail hi har e A an Figure 4 9 Enter Patient ID Version 1 0 English Page 15 Med Storm Pain Montior User Manual 5 Choose application mode by touching fmemisae anywhere within the Application 0 00 0 00 Mode field and then point on the de sired mode In these Getting started instructions we choose the Anaesthe sia mode For further information about the differ ent modes se chapter 0 JAN z EI vs 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 ABL im E easg ha LETE ar dn 000 000 je 0 00 0 00 L ue z SITE RE z i HE aK Figure 4 11 Start Stop button Figure 4 12 Measurement date and time 7 Verify that a graph is seen in the Skin Conductance pS 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 con tinuously To end and store a session use the Stop button The button will turn into a Go online button and the lo cation where the file is stored is shown above the graphs ry Par Figure 4 13 End and store session Version 1 0 English Page 16 Med Storm Pain Montior User Manua
37. stance in be tween each electrode shall be at least 7 mm 2 Attach the connectors of the electrode cable to the electrodes according to Table 4 2 Electrode Characterization Marking Placing in Figure 4 5 color Reference R Blue On either side of the ankle Measure M Black On the sole of the foot Current C Yellow On either side of the ankle Table 4 2 Skin electrode placement on infants Figure 4 5 Skin electrode placement on premature infants 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 require ments please refer to Appendix B of this manual Areas outlined in red in the figures are areas on the screen that have to be touched to per form 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 Version 1 0 English Page 13 Med Storm Pain Montior User Manual 4 3 1 Stress Detector user interface overview 3 s lt 14 13 PA TR mm ID Pb I 00 D DR RE 5 e ttt 10 Figure 4 6 Stress Detecto
38. the system a power supply holder could be 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 l Figure 3 41 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 lock ing collar for a secure connection Figure 4 1 Communication cable con necting to the MU 3 Connect the communication cable to the COMI 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 the key in the power connector 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 Version 1 0 English Page 10 Med Storm Pain Montior User Manual Note To disconnect the electrode cable pull straight out Do not twist the con nector 6 Ifthe power supply holder is used 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 sup ply to the holder Slip one of the large rubber rings over the PC power supply unit Place it towards the end opposite the f
39. 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 requirements 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 environ ment It should always be grounded protective earth in the same room as the pa tient if the PC should be outside the room of the patient Table B 2 Version 1 0 English Page 27 Med Storm Pain Montior User Manual Mechanical dimensions Weight kg Pain Monitor 0 37 210x113x41 Measuring unit incl On Off button and rubber feet PC 4 54 348 x 287 x 92 Table B 3 Weight and dimensions List of cables and maximum lengths of cables Maximum length m Model or part eee eee ee adult vation AS Fs infant vation AS cable alien AS Mains cable PC 12 11600 gt Mains cable MU 2 1 200 gt Table B 4 Cable lenghts The table of cable lengths also represents the list of cable
40. ve mode For post operative pain the mode is based on peaks per sec The peaks per sec increase when the patient s sensitivity to pain measured by the Numeric Rating Scale NRS or Visual Analogue Scale VAS increase 0 is no pain and 10 is worst thinkable pain Fig 4 21 The peaks per second number fluctuations of skin conductance NFSC shows the rate of firing in the sympathetic nerves This index changes background colour from white to yellow to orange to red according to the increase in NRS or VAS score Fig 4 22 the sensitivity to determine pain less than 3 or like 3 on the NRS or VAS has the peaks per sec less than or like 0 21 peaks per sec color from white to light yellow the sensitivity to determine pain more than 3 but less or like 5 on the NRS or VAS has the peaks per sec more than 0 21 peaks per sec but less than or like 0 27 peaks per sec color yellow the sensitivity to determine pain more or like 6 but less or like 10 on the NRS or the VAS has the peaks per sec more than 0 27 peaks per colour orange to red The in dex is also validated for pain in children and adult The index may also be influenced from other sympathetic nerve stimulation like nausea vomiting and anxiety The analys ing window should be 15 sec and the refresh time should be each sec 0 5 0 45 0 4 0 35 0 3 0 25 0 2 0 15 0 1 0 05 0 I NRS 1 3 NFSC Figure 4 21 Level of pain Ledowski T et al The assessment of postoperative pain
Download Pdf Manuals
Related Search