Med-Storm Pain Monitor™ User Manual

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Med-Storm Pain Monitor™ User Manual [Tapez un texte] Page 1 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: http://www.med-storm.com/ Med-Storm Pain Monitor™ User Manual [Tapez un texte] Page 2 IMPORTANT The user manual covers the operation of the MED-STORM Pain Monitor. 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. 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 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 fitness for a particular purpose. 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. Med-Storm Pain Monitor™ User Manual Version 1.0 Englsih Page 3 TABLE OF CONTENTS 1 Introduction ................................................................................................................ 4 1.1 Definitions ........................................................................................................... 4 1.2 Intended use ....................................................................................................... 4 1.3 Normal use ......................................................................................................... 4 1.4 Intended user ..................................................................................................... 4 1.5 Indications for use ............................................................................................. 4 1.6 Contraindications for use .................................................................................. 4 1.7 Pre use checks ................................................................................................... 4 2 Warnings .................................................................................................................... 5 2.1 Electrical shock hazard ..................................................................................... 5 2.2 Environmental conditions ................................................................................. 5 2.3 Warning and information symbols ................................................................... 5 3 Technical overview/Technical manual .................................................................. 6 3.1 System overview ................................................................................................ 6 3.2 Measuring Unit (MU) ......................................................................................... 7 3.2.1 Power supply ............................................................................................... 8 3.3 Computer ............................................................................................................ 8 3.3.1 Power supply ............................................................................................... 9 3.3.2 PC stand ...................................................................................................... 9 3.3.3 Power supply holder .................................................................................. 9 3.3.4 Pain Monitor application software ............................................................ 9 3.4 Electrode cable .................................................................................................. 9 3.5 Electrodes ........................................................................................................... 9 4 Operating Instructions ........................................................................................... 10 4.1 Instrument setup .............................................................................................. 10 4.2 Skin electrode placement ............................................................................... 11 4.2.1 Artifacts ...................................................................................................... 11 4.2.2 Skin electrode placement on adults ...................................................... 12 4.2.3 Skin electrode placement on infants ..................................................... 13 4.3 Software and settings ..................................................................................... 13 4.3.1 Stress Detector user interface overview ............................................... 14 4.3.2 Getting started .......................................................................................... 15 Calculated measurement values ......................................................................... 17 4.3.3 Choose application mode ....................................................................... 17 4.3.4 Features in Pain Monitor ......................................................................... 20 4.3.5 Data transfer ............................................................................................. 23 4.4 Error conditions ................................................................................................ 23 5 Care and maintenance .......................................................................................... 24 5.1 Life time ............................................................................................................. 24 5.2 Preventive maintenance ................................................................................. 24 5.3 Simplified function tests .................................................................................. 24 5.4 Support information ......................................................................................... 24 5.5 Cleaning ............................................................................................................ 24 5.6 Scrapping instructions ..................................................................................... 25 Appendix A - Environmental and handling conditions .............................................. 26 Appendix B - Technical specifications ........................................................................ 27 Appendix C - Safety Standards and regulations ....................................................... 29 Appendix D - Electromagnetic compatibility ............................................................... 30 Appendix E - Protection against data virus ................................................................ 34 Appendix F – Pre use checklist .................................................................................... 35 Appendix G – Physiological and clinical function of the Skin Conductance Monitor ........................................................................................................................................... 36 Med-Storm Pain Montior™ User Manual Version 1.0 English Page 4 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 MU (Skin conductance) Measuring Unit NRS Numerical Rating Scale VAS 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 • patients undergoing anaesthesia • postoperative patients • patients in the intensive care units • infants from 25 weeks of gestational age 1.6 Contraindications for use • The device shall not be used at patients with skin conditions which may affect skin conductance. E.g. injury of the skin. • The device shall not be used with patients with electrically sensitive life support systems (e.g. implantable pacemaker or defibrillator). • The device shall not be used when the 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. Med-Storm Pain Montior™ User Manual Version 1.0 English Page 5 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 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 Med-Storm Pain Montior™ User Manual Version 1.0 English Page 6 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. The Pain Monitor from Med-Storm consists of: Measurement equipment # in sketch Part # Measuring Unit (MU) 1 1001 Power supply unit for MU with a power cable 4 1002 Mains cable for power supply MU, European 6 2001 Electrode cable adult, European 2 2010 Communication cable 3 2012 Presentation software [not in sketch] 3001 Manual, version 1.0 English [not in sketch] 4001 Short manuals, infants, postoperative and intensive care, and anaesthesia [not in sketch] 4002 Operator station # in sketch Part # PC 7 6001 Power supply unit with power cable 8 6002 Mains cable for power supply PC, European 9 6003 PC table stand 10 6008 Accessories # in sketch Part # Mains cable for power supply MU, American 6 2002 Electrode cable, infant European 2 2011 Electrode cable, adult American 2 2013 Electrode cable, infant American 2 2014 Mains cable for power supply PC, American 9 6004 Power supply holder with rubber rings and cable collector band [not in sketch] 5001 Note. The use of accessories, transducers and cables other than those specified may result in increased emission or decreased immunity of the system. Med-Storm Pain Montior™ User Manual Version 1.0 English Page 7 1. Measuring Unit (MU) 2. Electrode cable 3. Com. cable 4. Power supply MU 9. Mains cable for PC power supply 7. Display PC 6. Mains cable for MU power supply 10 . PC stand 8. Power supply PC 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 4 Figure 3-2 Measuring Unit Med-Storm Pain Montior™ User Manual Version 1.0 English Page 8 Figure 3-3 Measuring Unit power supply 3.2.1 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: • power supply inlet [1] • ON/OFF button [2] • Communication cable connector [5] For data transfer or system management, the following connectors (Figure 3-5) can be used: • Network cable connector [3] • 4 USB connector [4] (for optional connection of Keyboard, Mouse and/or Memory stick) Figure 3-5 PC connectors 1 2 3 4 5 Med-Storm Pain Montior™ User Manual Version 1.0 English Page 9 Figure 3-6 PC power supply unit 1 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. 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 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. 3.5 Electrodes Different electrodes can be used for adult patients and premature infants after tested and recommended by Med-Storm. Med-Storm recommends that electrodes from Med- Storm are used. Figure 3-7 Electrode cable 1 2 Figure 3-8 Electrodes for adult patients Med-Storm Pain Montior™ User Manual Version 1.0 English Page 10 4 Operating Instructions The following instructions describe all necessary steps required to set-up and operate the Pain Monitor. 4.1 Instrument setup When assembling 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. Connect the power cable to the MU. See 1. 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. 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 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. Note. This system must not be used on a patient with an implanted pacemaker or defibrillator. Figure 4-1 Communication cable con- necting to the MU 1 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. 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. Med-Storm Pain Montior™ User Manual Version 1.0 English Page 11 6. If the 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 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 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 maximum time of 48 hours. Figure 4-2 Correct way of disconnecting the electrodes Figure 4-3 Do not pull on the electrode cable it- self 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. Note. To disconnect the electrode cable, pull straight out. Do not twist the con- nector. Note. To disconnect, pull out each electrode connector separately. Do not pull on the electrode cable itself. Med-Storm Pain Montior™ User Manual Version 1.0 English Page 12 Electrode Characterization in Figure 4.4 Connector color Placing Reference R Blue Below long finger of the hand Measure M Black Hypothenar eminence of the hand Current C Yellow Hyperthenar eminence side of the hand 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. Table 4-1 Skin electrode placement on adults Figure 4-4 Skin electrode placement on adults Med-Storm Pain Montior™ User Manual Version 1.0 English Page 13 Electrode Characterization in Figure 4.5 Marking color Placing 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 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 distance 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 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. Med-Storm Pain Montior™ User Manual Version 1.0 English Page 14 4.3.1 Stress Detector user interface overview Figure 4-6 Stress Detector user interface overview 1. Patient ID field 2. Current measurement values 3. Skin conductance graph 4. Time scroll bar 5. Start/Stop/Go online button 6. Load saved data 7. Export data to Excel format 8. Configure settings 9. Event marker 10. Close the Stress Detector Appli- cation software 11. Auto fit time scale to 15 sec 12. Zoom out 13. Zoom in 14. Overview graph 15. Choose application mode 11 15 13 12 1 6 8 9 7 10 3 2 4 5 14 Med-Storm Pain Montior™ User Manual Version 1.0 English Page 15 4.3.2 Getting started 1. Turn on the computer using the on/off button. Se part 3.3 Computer . 2. The Pain Monitor application software should auto start. If not, touch the desk- top icon “ SCMS ” to start the Pain Monitor application software. 3. The Pain Monitor application software starts and following window will be visible on the screen. The software starts in a mode that shows measured data without saving it. Figure 4-8 Pain Monitor software 4. To enter an ID for a patient touch the “ 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 starts to be saved. Figure 4-9 Enter Patient ID Figure 4-7 Start SCMS software Med-Storm Pain Montior™ User Manual Version 1.0 English Page 16 5. Choose application mode by touching anywhere within the “ Application 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. 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. Figure 4-11 Start/Stop button Figure 4-12 Measurement date and time 7. Verify that a graph is seen in the “ Skin Conductance [ μ S] ” 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. 8. 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. Figure 4-13 End and store session Med-Storm Pain Montior™ User Manual Version 1.0 English Page 17 9. To start measuring again, touch the “ Go online ” button. To start a new session start again from number 4. 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 - μS] 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 - μS/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 - μSs] 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 registration curve and the established baseline when they are larger than the baseline. This is illustrated in Figure 4-15 Med-Storm Pain Montior™ User Manual Version 1.0 English Page 15 Figure 4-15 Calculation of area huge peaks Med-Storm Pain Montior™ User Manual Version 1.0 English Page 16 Area small peaks [micro Siemens seconds - μSs] 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. Figure 4-16 Calculation of area small peaks Area under curve [micro Siemens seconds - μSs] 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 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. Med-Storm Pain Montior™ User Manual Version 1.0 English Page 17 4.3.3 Choose application mode Choose between different application modes by touching anywhere in the “ Ap- plication Mode” field and then mark one of the modes, fig. 4-17. The different modes affect which meas- urement values are displayed above the graph windows. Figure 4-17 Choose application mode During anaesthesia In the “ Anaesthesia ” application mode the measurement values shown are, fig. 4-18: • Peaks/sec • Area under curve 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 YELLOW: 0.21-0.27 peaks per sec ORANGE: 0.33 peaks per sec RED: 0.40 peaks per sec or more Figure 4-18 Figure 4-19 Post operative Med-Storm Pain Montior™ User Manual Version 1.0 English Page 18 In “ Post operative ” application mode the measurement values shown are, fig. 4-20: • Peaks/sec Figure 4-20 Post Operative 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. Figure 4-21 Level of pain (Ledowski T et al. The assessment of postoperative pain by monitoring skin conductance results of a prospective study. Anaesthesia 2007, 62:989-993). Med-Storm Pain Montior™ User Manual Version 1.0 English Page 19 WHITE: 0.00 – 0.07 peaks per sec No pain LIGHT YELLOW: 0.13 - 0.21 peaks per sec No pain or VAS 1-3 YELLOW: 0.27 peaks per sec Patient is active, can be pain VAS 4-5 or other stressors ORANGE: 0.33 peaks per sec Patient is possible in pain, VAS 6-8, go and evaluate the situation RED: 0.40-0.70 peaks per sec 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: • Peaks/sec 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 like 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. Med-Storm Pain Montior™ User Manual Version 1.0 English Page 20 T a b l e 4 Prechtl’s Five Point Scale, WHITE: 0.00-0.07 peaks per sec The infant is calm LIGHT YELLOW: 0.14 peaks per sec The infant is calm and move a little YELLOW: 0.21-0.27 peaks per sec The infant is active, observe the infant, pain / dis- comfort threshold is reached ORANGE: 0.33 peaks per sec The infant is probably in pain / discomfort, evaluate the situation RED: 0.40 peaks per sec or more 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: • Area huge peaks • Area small peaks • The hugest of these areas are also seen. • Peaks/sec • Average Peak • Average Rise Time Figure 4-25 Research mode • Signal Quality 4.3.4 Features in Pain Monitor Time scale Adjust the time scale by using the three but- tons in the lower right corner, Fig. 4-26. Zoom in Zoom out Auto fit time scale to 15 s zoom Figure 4-196 Features in Pain Monitor Prechtl’s Five Point Scale 1 Eyes closed, regular respiration, no movements. 2 Eyes closed, irregular respiration, small move- ments. 3 Eyes open, no movements. 4 Eyes open, gross movements. 5 Crying (vocalisation) Med-Storm Pain Montior™ User Manual Version 1.0 English Page 21 Mark event 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. Figure 4-208 Enter comment 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 port 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 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. Figure 4-29: Configure Med-Storm Pain Montior™ User Manual Version 1.0 English Page 22 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 “O k” 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 ” button 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 touching the “ Load patient ” button, an- other path than the desired are chosen in settings. The files available depend on which Figure 4-30 Load patient data path that has been set. Export recorded data To use the “ Export ” feature, a mouse and keyboard must be used, Fig. 4-31. The Ex- port 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 com- 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. 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. Figure 4-31 Export data Med-Storm Pain Montior™ User Manual Version 1.0 English Page 23 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 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. 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- ence to indicate that the recorded signal is not reliable. See Figure 4-32 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 error state will be indicated by a red warning text “Connection lost to MU” and with an orange background in the graph. . Med-Storm Pain Montior™ User Manual Version 1.0 English Page 24 Using heating mattress, GVP Elettronica, SCL-MED (DM-WARM-12 commercial brand) gvp_md1@gvp.it, interference has been observed at the Skin Conductance registration curve. Figure 4-33 Contact lost warning 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 Instrument 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 Email support@med-storm.com 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. Med-Storm Pain Montior™ User Manual Version 1.0 English Page 25 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. Never use ether or petroleum-based solvents. Med-Storm Pain Montior™ User Manual Version 1.0 English Page 26 Appendix A - Environmental and handling conditions Measuring Unit Operating Ambient temperature +10 0 C – +30 0 C (50 0 F – 86 0 F) Ambient pressure 700hPa – 1060hPa (10.2 PSI – 15.4 PSI) Ambient humidity 30% - 75% Transport Ambient temperature -10 0 C – +70 0 C Ambient pressure 500hPa – 1060hPa (7.3 PSI – 15.4 PSI) Ambient humidity 10% - 90% Storage Ambient temperature +10 0 C – +30 0 C (50 0 F – 86 0 F) Ambient pressure 700hPa – 1060hPa (10.2 PSI – 15.4 PSI) Ambient humidity 30% - 75% Degree of enclosure pro- tection IP X0 Vibration / Shock / Bump It is possible to transport the system worldwide by air, road, ship and train. Drop / Free fall It is possible to transport the system worldwide by air, road, ship and train. EMC/ESD The Pain Monitor meets requirements in accordance with IEC 60601-1-2 Electromagnetic compatibility. The device complies with Part 15 of the FCC Rules" Med-Storm Pain Montior™ User Manual Version 1.0 English Page 27 Appendix B - Technical specifications Measurements ac- curacy Noise level (1 – σ ) below 0,002 μ S. This applies for resistive measurements on 100 μ S. Measurement range 1-200 μ S Classification of medical device Class II A Maximum current definition 36 μ A RMS The maximum value of current that can be supplied to a patient trough the C electrode. Storage capacity Disc capacity is 2 GB. 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 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 supply 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. • The PC must be IEC 60601-1 graded if used within the patient environment. • 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 Med-Storm Pain Montior™ User Manual Version 1.0 English Page 28 Mechanical dimensions Part Weight [kg] Dimensions [mm] Pain Monitor Measuring unit ~0,37 210x113x41 (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 Cable Maximum length [m] Manufacturer Model or part # Electrode cable, adult 2 Med-Storm Inno- vation AS 2010 Electrode cable, infant 2 Med-Storm Inno- vation AS 2011 Communication cable 2,5 Med-Storm Inno- vation AS 2012 Mains cable, PC 2 6003 Mains cable, MU 2 2001 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 re- quirements in IEC60601-1 and any national deviations must be used when installing the Pain Monitor. Med-Storm Pain Montior™ User Manual Version 1.0 English Page 29 Appendix C - Safety Standards and regulations The Pain Monitor meets the requirements of the following safety standards and regula- tions: Standard Referred to as The DIRECTIVE 93/42/EEC 93/42/EEC IEC 60601-1 Medical electrical equipment IEC 60601-1 IEC 60601-1-1 Safety requirements for medical electrical systems IEC 60601-1-1 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 The device complies with Part 15 of the FCC Rules. Med-Storm Pain Montior™ User Manual Version 1.0 English Page 30 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 CISPR 11 Group 2 The Pain Monitor must emit electromag- netic energy in order to perform its inter- nal function. Nearby electronic equipment may be affected. RF emissions CISPR 11 Class B Harmonic emissions IEC 61000-3-2 Class B Voltage fluctuations/ flicker emissions IEC 61000-3-3 Complies The Pain Monitor is suitable for use in all establishments, including domestic estab- lishments and those directly connected to the public low-voltage power supply net- work that supplies buildings used for do- mestic purposes. Table D-1 Electromagnetic compatibility 201 The device complies with Part 15 of the FCC Rules" Med-Storm Pain Montior™ User Manual Version 1.0 English Page 31 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 level Electromagnetic environment – guidance Electrostatic dis- charge (ESD) IEC 61000-4-2 +/- 6 kV contact +/- 8 kV air +/- 6 kV contact +/- 8 kV air Electrical fast tran- sient / Burst IEC 61000-4-4 +/- 2 kV for power supply lines +/- 1 kV for input/output lines +/- 2 kV for power sup- ply lines +/- 1 kV for in- put/output lines Surge IEC 61000-4-5 +/- 1 kV differential mode +/- 2 kV common mode +/- 1 kV differential mode +/- 2 kV common mode Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 <5 % UT (>95 % dip in UT) for 0,5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT)) for 5 sec <5 % UT (>95 % dip in UT) for 0,5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT)) for 5 sec Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 3 A/m 3 A/m NOTE UT is the a.c. mains voltage prior to application of the test level. Table D-2 Electromagnetic immunity 202 Med-Storm Pain Montior™ User Manual Version 1.0 English Page 32 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 level Electromagnetic environment - guidance 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. Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz 3 V Recommended separation distance Radiated RF IEC 61000-4-3 3 V/m 80MHz to 2,5GHz 3 V/m where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as deter- mined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol. NOTE 1 At 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. a 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. b 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 Med-Storm Pain Montior™ User Manual Version 1.0 English Page 33 Pain Monitor 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. Separation distance according to frequency of transmitter (m) Rated maximum output power of transmitter (W) 150 kHZ to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz 0,01 0,12 0,12 0,23 0,1 0,38 0,38 0,78 1 1,2 1,2 2,3 10 3,8 3,8 7,8 100 12 12 23 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 Med-Storm Pain Montior™ User Manual Version 1.0 English Page 34 Appendix E - Protection against data virus Data virus is a threat to the functionality of the Pain Monitor 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 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. Med-Storm Pain Montior™ User Manual Version 1.0 English Page 35 Appendix F – Pre use checklist Check Signature Verify that the system is not going to be used 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 if 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. Med-Storm Pain Montior™ User Manual Version 1.0 English Page 36 Appendix G – Physiological and clinical function of the Skin Conductance Monito r 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 [μS]. The physiological process is shown in Figure G-2. 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 is not influenced from neuro muscular blockers (act- ing on nicotine receptors). 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 (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. 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.