STIMPOD NMS410/450 Instructions for Use
Contents
1. include both current and pulse width settings pulse width cannot be adjusted independently in this mode This is indicated on the screen by the fact that pulse width is not highlighted Y Zh 0 90mA 4 0 90mA 2 4 Adjusting the Twitch Frequency Options in the Setup Menu 1Hz 2Hz 5Hz Default 2Hz Press Enter Hz button to toggle between different stimulating frequencies 3 Operating Device in Nerve Mapping Locating Mode NMS 410 450 Percutaneous nerve mapping enables the anaesthesiologist to map out a particular superficial nerve prior to nerve location with the needle This is accomplished by stimulating the motor component of the relevant peripheral nerve percutaneously with the nerve mapping probe This technique ensures a higher success rate for directing the needle to the correct nerve This mode offers the user the means to do nerve mapping and locating without having to switch or unplug cables When inserting the Nerve Mapping Locating Cable the STIMPOD will default to the Nerve Mapping current range 0 20mA Current will be directed to the Nerve Mapping probe and the STIMPOD will attempt to stimulate The moment that the needle penetrates the skin the cable will sense it and inform the STIMPOD The STIMPOD will switch to Nerve Locating mode and behave as described in chapter 2 If contact between the needle and patient is broken and the nerve mapping probe touches the patient STIMPOD will switch back to the n2. 1 7 7 Table 5 1 B 2 A aE 2 23 3 34 Bo as 48 8 ll 4 7 il H al i al 1 al l 4 il jl 1 D 5 e 3 Ece l oa It should be noted that the charge of the default values shows a typical quadratic curve At a pulse width of 0 1ms the current follows the charge 10 11 12 13 14 15 16 Pulse Width 17 18 19 20 Charge Current Figure 5 1 Once a limit of 5mA is reached the pulse width is increased to 0 3ms After 0 3ms the slope of the charge on the graph is increased NOTE Each position in this adjustment mode can be defined individually The user is advised to experiment and adjust the values in order to meet clinical expectations NOTE In this mode the Pulse Width is preset and linked to a specific position When operating the device in this mode the Pulse Width button is deactivated All positions are accessed sequentially by manipulating the wheel Use the Wheel to navigate to CURRENT MODE Press enter to select CURRENT MODE O Linear Mode Non Linear Mode EXIT MENU To adjust the default position values use the Wheel to navigate to Non Linear Mode Press enter to select The radio button next to Non Linear will show that it has been activated CURRENT MODE You have selected Non Linear Mode A Confirmation screen will show your selection with an option to ACCEPT YES will take you to the next screen NO will take you back to the Current Mod
3. A sterile wipe should be applied to the Nerve Mapping Probe prior to use Nerve Locating Cable e This cable is used to activate the Nerve Locating mode on the STIMPOD e The red anode connector is designed to clip on to a standard ECG electrode e The 2mm needle connector will accommodate various makes of needles Nerve Mapping Nerve Locating Cable This cable is used to activate the Nerve Mapping Nerve Locating mode on the STIMPOD The red anode connector is designed to clip on to a standard ECG electrode The ergonomically designed cutaneous Nerve Mapping Probe presents the user with a simple and reliable Nerve Mapping solution The 2mm needle connector will accommodate various makes of needles NMBA Monitoring Cable NMS450 e This cable is used to activate the NMBA mode on the STIMPOD e The red anode and black cathode connectors are designed to clip onto the Xavant NMBA electrode XT45008 NA or onto a standard ECG electrode e The accelerometer is designed to attach to the contracted appendage in the case of the ulnar nerve this will be the thumb Carry Case lt gt lt gt Batteries e This unit uses 4 x AAA penlight batteries e Lithium batteries are recommended e When the battery is depleted the unit will prompt the user to replace the battery and switch off e Switch device off and remove all cables before replacing battery e Remove battery if the device is not to be used for an extended p
4. Medium d High 1 To change the speaker volume use the Wheel to navigate to SPEAKER VOLUME in the main menu Press enter to select Use the wheel to select the appropriate volume and enter Scroll down the menu to EXIT MENU and press enter SPEAKER VOLUME SPEAKER VOLUME You have selected High A Confirmation screen will show the new selected volume with an option to ACCEPT YES will take you to the main Setup Menu ACCEPT NO NO will take you back to the previous screen 5 9 Backlight DEFAULT 5 Seconds Options OFF 5 seconds 60 seconds and Always On BACKLIGHT O Off To change the default Backlight setting use the Wheel to navigate to BACKLIGHT in the main menu Press enter to select The radio button next to the selected setting will show that it has been activated Scroll down the menu to EXIT MENU and press enter er On BACKLIGHT You have selected Always On A confirmation screen will show your selection with an option to ACCEPT Battery life will be Adversely affected ACCEPT NO YES will take you back to the main Setup Menu NO will take you back to the previous screen NOTE If the selected backlight option is Always On the battery life will be drastically shortened 5 10 User Information DEFAULT No default The STIMPOD offers the user the option to enter user information Two lines of 20 characters each may be entered This user information will be display
5. Open Circuit Detected TOF an XN e The LED should flash RED and no audible feedbac e If the STIMPOD malfun should be check with the 1 6 2 Specifications NMS 410 450 NMS 410 450 Pulse Width Options 0 05ms 0 1ms 0 3ms 0 5ms 1ms 5 0 05ms 0 1ms 0 3ms 0 5ms 1ms 5 Stimulus Monophasic square wave Monophasic square wave Load Impedance 0 kOhm 20 kOhm 0 kOhm 20 kOhm NMS 410 450 Power Supply 4 x AAA alkaline batteries Waveform Constant Current Monophasic Square Wave Dimensions 145mm x 90mm x 30mm Storage and Transport Temperature 0 50 Celsius Transport and Storage Humidity 90 Relative Humidity Transport and Storage Atmospheric Pressure 50 106kPa 6 3 Cleaning and Disinfecting STIMPOD NMS410 450 Cleaning Soap and water applied with a damp cloth is suitable to clean and disinfect the STIMPOD It is imperative t 23 NMS 450 0 2ms 5 Monophasic square wave 0 kOhm 5 kOhm 7 Products amp Accessories NMS 410 PERIPHERAL NERVE STIMULATOR ONLY Product Code XT 41000 NA No cables or accessories NMS 410 PERIPHERAL NERVE STIMULATOR Product Code XT 41001 NA Including Probe Locator Carry Case IFU NMS 450 PERIPHERAL NERVE STIMULATOR ONLY Product Code XT 45000 NA No cables or accessories NMS 450 PERIPHERAL NERVE STIMULATOR Product Code XT 45011 NA Including Probe Lo
6. The LED should flash GREEN and if sound is enabled in the menu a beep should ek ie nia be heard each time a stimulus is delivered e Stimulus should occur at the set frequency 1 2 or 5 Hz e Use the adjusting wheel and slowly increase the current to 5 00mA e Monitor that the stimulating waveform measured and displayed in the diagnostic window is square The top part of the square wave should also touch the dotted line which represents the current setting as shown below 0 50mA errr 6 1 1 Nerve Locating Mode I lt gt 2 Hz NMS4x0 Vx 00 User Information followed by e Insert the Nerve Locating Cable 6 1 2 Combined Nerve Mapping Nerve Locating Mode The following screen should appear on the display e Insert the Combined Nerve Mapping Nerve Locating Cable 0 00mA L o The following screen should appear on the display Om ee o Zz AN Open Circuit Detected M FIA e The LED should flash RED and no audible feedback should be heard 7 i HA A Open Circuit Detected e The LED should flash RED and no audible feedback should be heard e Short circuit the Nerve Mapping probe and the ECG connector The following screen should appear on the display TE a OmA 4 0 01mA 4000c FJA e The LED should flash GREEN and if sound is enabled in the menu a beep should be heard each time a stimulus is delivered e Stimulus should occur at the set frequency 1 2 or 5 Hz e Use the adjust
7. black electrode clips as well as the tri axial accelerometer e Press the Mode button until PTC is shown on the display ED Zh 20 0mA Real time Accelerometry e Each counted twitch Is indicated graphically in the diagnostic screen as shown in the picture The number of twitches counted are displayed in the diagnostic screen The three modes TOF DB and PTC are subject to refractory period delays providing a safety period which prevents the user from repeating stimulation while the nerve synapse is recovering from the effects of the previous stimulation Immediately after stimulation in one of these modes the countdown timer is activated and shown on the screen If repeat mode is activated only the repeat timer will be displayed on the screen because the repeat period for the repeat timer will always be larger than the refractory period timer If an attempt is made to stimu late while the refractory timer is active a warning screen will be displayed reminding the user that the refractory period Is active Default refractory period delays are as follows for the three modes TOF 15 seconds DB 1 minute PIC 2 minute 4 10 Twitch TWI Defaults Repeat at 2Hz Adjustable 1Hz 2Hz and 5Hz The Twitch stimulation comprises a 200 microseconds square wave pulse If the Play Pause button is pressed the twitch will repeat at the selected frequency Selecting TWI Mode e Insert the NMBA cable with the r
8. for every position with an option to ACCEPT YES will take you back to the main Setup Menu NO will take you back to the screen showing all the positions with their respective current and pulse width settings Pulse Width Options Options 0 05ms 0 1ms 0 3ms 0 5ms 1 0ms Use this setup function to activate the preferred pulse widths To change the default pulse widths use the Wheel to navigate to PULSE WIDTH in the main menu Press enter to select The radio button next to the selected pulse width will show that they have been activated EXIT MENU To exit scroll down the menu to EXIT MENU and press You have selected enter A confirmation screen will show your selection 0 1 ms 0 3 ms with an option to ACCEPT YES will take you back to the main Setup Menu NO will take you back to the previous screen NOTE If all pulse widths are deselected the STIMPOD will default to 0 1ms and 0 3ms ACCEPT NO 5 4 Stimulating Frequency DEFAULT 2Hz Options 1Hz 2Hz and 5Hz FREQUENCY To change the default frequency use the Wheel to navigate oi to FREQUENCY in the main menu Press enter to select The radio button next to the selected frequency will show O5 Hz that it is has been selected Scroll down the menu to EXIT MENU and press enter FREQUENCY A confirmation screen will show your selection with an You have selected option to ACCEPT 1 Hz YES will take you back to the main Setup Menu NO will take you bac
9. AUSE button to be pressed again Cable Not Cable not recognised AN ADe i Q This warning informs the user that the inserted cable is not compatible with the NMS 410 450 Recognised Replace Batteries This warning informs the user that the batteries are depleted beyond an acceptable level Continuing to operate the device thus will make it unreliable To prevent this the STIMPOD flashes this warning for 4 seconds before switching off AN Replace Batteries Open Circuit Detected This warning informs the user that the two electrodes i e ECG electrode and needle or mapping device do not form Detected a closed circuit This warning will be accompanied by a red flashing LED every time the unit attempts to stimulate Open Circuit Current Adjustment in NMBA Mode Press Enter When attempting to adjust the current while in NMBA mode the device will show this message requesting the user to confirm the adjustment of the current To Confirm Refractory Delay Active AN Refractory Once a TOF DB or PTC stimulation is performed the refractory period timer is initiated During the countdown time Delay Active it will not be possible to perform another stimulation If another stimulation is attempted this warning screen will appear Component Error The STIMPOD has detected a component failure Please send the device back to the manufacturer for repair AN AN AN 1 6 Open Circuit Detection Open Cir
10. Manufacturer Xavant Technology PTY LTD Unit 102 The Tannery Industrial Park 309 Derdepoort Rd Silverton Pretoria South Africa 0184 Tel 27 0 12 743 5959 Fax 27 0 86 547 0026 E mail support xavant com Web www xavant com Legal Representative in the EU Emergo Europe 15 Molenstraat 2513 BH The Hague The Netherlands Caution Federal US law restricts this device to sale by or on the order of a physician Indications for use This product is a nerve stimulation device designed to be used by an anaesthetist during e General Anaesthesia for the purpose of establishing the efficacy of a Neuromuscular Blocking Agent using non invasive surface electrodes not sup plied NMS450 e Regional Anaesthesia for the purpose of e Nerve mapping using the non invasive Nerve Mapping Probe supplied e Nerve locating using invasive electrodes needles not supplied Contraindications e Infection of the puncture site e Known neurological disorders Severe coagulation disorders Warnings Read the entire User Manual before attempting to use the device Use of cables or accessories other than those supplied with the STIMPOD may result in serious injury Maintenance on this device may only be performed by the manufacturer or persons explicitly authorized by the manufacturer Do not use the STIMPOD in close proximity to equipment that produces strong electromagnetic fields such as high frequency surgical equipment The ca
11. according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated maximum output power 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz Not applicable For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 Mz the separation distance for the higher frequency range applies NOTE2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Guidance and manufacturers declaration electromagnetic immunity for equipment and systems that are non life supporting The STIMPOD NMS410 NMS450 is intended for use in the electromagnetic environment specified below The customer or the user of the STIMPOD NMS410 NMS450 should assure that it is used in such an environment Immunity Test IEC 60601 test level Compliance level Electromagnetic environment guidance Radiated immunity 80MHz 1GHz 3V m amp 80MHz 1GHz 3V m amp Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL EQUIPMENT and should be used no closer to any part of the equipment including cabl
12. ar because one click on the wheel will correspond with one increment as set in the specific current range In the linear mode Pulse Width is not affected when turning the wheel Pulse Width is selected when the Menu Pulse Width button is pressed The Linear Mode essentially allows the user to select three different increment options for three different current ranges Use the Wheel to navigate to CURRENT MODE Press enter to select CURRENT MODE Linear Mode O Non Linear Mode EXIT MENU Use the Wheel to navigate to Current Mode Press enter to select The radio button next to Linear Mode will show that it is activated To exit scroll down the menu to EXIT MENU and press enter CURRENT MODE A confirmation screen will show your selection with an You have selected option to ACCEPT Linear Mode YES will take you to the next screen NO will take you to the Current Mode Menu ACCEPT NO LINEAR MODE The next screen will enquire whether the user would like to Change Settings change the settings YES will take you to the next screen NO will take you back to the main Setup Menu NO RANGE 0 0 0 6mA The first range will be 0 00mA 0 60mA In this range the user can select one of the following increment options 0 01mA 0 02mA 0 05mA and0 1mA The default setting is 0 05mA Select the desired increment and proceed to NEXT RANGE CHOOSE INCREMENTS RANGE 0 6 2 0mA The second range will be 0 6mA 2 0mA I
13. ble leads could act as antennae and dangerous currents could be induced as a result Do not apply the STIMPOD to patients with implanted electrical devices such as cardiac pacemakers without first consulting with an appropriate medical specialist The device should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary the device should be observed to verify normal operation in the configuration in which it will be used The patient should avoid contact with metallic objects that are grounded produce an electrical conductive connection with other equipment and or enable capacitive coupling The cables should be positioned in such a way that they do not contact either the patient or other cables Simultaneous connection of a patient to high frequency surgical ME equipment and the STIMPOD may result in burns and possible damage to the stimulator Operation in close proximity e g 1m to a shortwave or microwave therapy ME equipment may produce instability in the stimulator output Application of electrodes near the thorax may increase the risk of cardiac fibrillation Cautions Prior to changing the batteries be sure to switch off the device and remove all the cables Remove elements which may adversely affect the connection between the electrodes and the skin e g dirt hair oil Ensure that ECG electrodes are not damaged or dried out Large current densities associated with failin
14. cator NMBA Cable with Accelerometer Carry Case IFU NERVE LOCATING CABLE Product Code XT 41003 NA NERVE LOCATING MAPPING CABLE Product Code XT 41004 NA NMBA CABLE WITH ACCELEROMETER Product Code XT 45015 NA POLYPROPYLENE CARRY CASE Product Code XT 41002 ACCELEROMETER STRAP Pack of 5 Product Code XT 45007 NA NMBA ELECTRODE Pack of 10 Product Code XT 45008 NA INSTRUCTIONS FOR USE Product Code XT 45006 EN Refer to www xavant com for additional languages North America only e g Product Code XT 45005 NA
15. cuit The Stimpod performs impedance measurements at regular intervals to detect Detected whether the connection between the STIMPOD and the patient comprises a closed circuit l Closed Circuit Detected Open Circuit Detected l e Stimulation will take place e No stimulation will take place e Stimulating sound will be heard Single or multiple beeps depending on No stimulating sound will be heard proximity indicator setting Sound pitch will follow the current intensity e The LED stimulus indicator will pulse red with every unsuccessful stimulus e The LED stimulus indicator will pulse green with every successful stimulus attempt attempt e A warning screen will appear in the diagnostics screen indicating that an e The diagnostic screen will provide active feedback on every pulse delivered open circuit was detected 1 7 Auto Shutdown STIMPOD will shutdown after 10 minutes of no user or patient interaction 1 8 Symbols on device battery clip SN Manufacturer Caution Separate collection for electrical Manufacturing Date Serial Number Representative and electronic equipment Year in the EU Applicable to EU community only A Type BF Consult instructions Applied Part for use 2 Operating Device in Nerve Locating Mode NMS 410 450 Localisation of nerves by electrical stimulation involves connecting the nerve stimulator to a conducting locating needle not supplied through which local anaesthetics can be admin
16. d Muscle Contracting Appendage adductor pollicis muscle Posterior tibial nerve flexor halluces brevis muscle Facial nerve Zygomatic orbicularis oculi muscle Eye lid Branch Facial nerve Temporal corrugator supercili muscle Eye brow Branch Electrode placement relies on the cathode black electrode clip to be as close to the targeted nerve as possible in order to effectively depolarize the nerve The anode red electrode clip should be away from the targeted nerve 4 2 Accelerometer Placement The tri axial accelerometer should be attached to the contracting appendage of the patient to measure the strength of the contraction resulting from the applied electrical stimulus The accelerometer is only used in the Train of Four Double Burst and Post Tetanic Count Modes to facilitate monitoring of the efficacy of the Neuromuscular Blocking Agent When using the Neuromuscular Blocking Agent Monitoring Mode NMS 450 4 3 Adjusting the Current When attempting to adjust the current in NMBA N mode the Stimpod will show a message requesting to confirm the adjustment of current When this mes sage appears press the enter button This will cause the current intensity to flash on and off which means that the current can now be adjusted If current has not been adjusted for more than 2 seconds the current will be set Default Current range 0 80 mA adjustable in 5mA increments Circle the Wheel to adjust cu
17. e Menu ACCEPT NO NON LINEAR MODE Change Settings NO CHOOSE POSITION 14 3 80mA 0 1ms 15 4 30mA 0 1ms 16 4 80mA_ 0 1ms 17 _1 80mA_0 3ms 18 2 10mA 0 3ms ADJUST POSITION 17 mA ms 0 1 ms Charge 00 24 uC A 17 gt 18 La ACCEPT NO 5 3 DEFAULT 0 1ms 0 3ms The next screen will enquire whether the user would like to change the settings YES will take you to a screen showing all the positions and their values NO will take you back to the main Setup Menu All positions will be shown with their respective current and pulse width settings Scroll down to the position that needs to be adjusted and press enter When entering the screen the current setting will be highlighted Adjust to the required value and press enter Next the pulse width setting will be highlighted Adjust to the required value and press enter The STIMPOD will calculate and display the charge as adjustments are made NOTE A warning will indicate if the net charge resulting from the user s settings is either lower than the previous position or higher than the following position Once a new current and pulse width setting has been entered for the relevant position the device will again show all the positions and their values The user can now adjust any other position values following the same steps To exit scroll down the menu and EXIT MENU and press enter A confirmation screen will draw a graph reflecting the net charge
18. ed and black electrode clips as well as the tri axial accelerometer e Press the Mode button until TWI is shown on the display Stimulate Stop Start stimulation by pressing the Play Pause button Stop stimulation by pressing the Play Pause button again ea i i 20 mA 20 0mA Frequency adjustment Press the Hz button to toggle through the frequencies 4 12 Single Stimulus vs Repeated Stimulation 4 11 Tetanus TET Defaults 50Hz adjustable to 100HZz The Tetanus stimulation comprises series of 200 microseconds square wave pulses repeated at a 50Hz or 100HZz repetition rate or frequency Selecting TET Mode e Insert the NMBA cable with the red and black electrode clips as well as the tri axial accelerometer e Press the Mode button until TET is shown on the display REY 0 ah 20 mA 20 0mA Stimulate Stop Start stimulation by holding the Play Pause button down Stop stimulation by releasing the Play Pause button e Start the automatic repeat mode by holding the play pause button down for longer than 2 seconds e The device will automatically start a countdown according to the repeat timer setting as specified in the main menu for each respective mode s timer e The countdown will be indicated next to the clock symbol shown in the diagnostic screen e Disable the automatic repeat mode by pressing and holding the play pause button again e The Repea
19. ed for two seconds when unit is switched on as per example SCAVANT TECHNOLOGY NMS410 v1 00 DR DRAKE RAMORAY ST PAULS HOSPITAL Use the Wheel to navigate to USER INFORMATION in the ENTER TEXT LINE 1 main menu Press enter to select A cursor will appear at the first character s position Use the Wheel to navigate to different characters Press enter to select the character A Characters let 46 and move to the next space Press enter on the jal character for backspace on the i character for a space and on the P amp M character to enter the line A warning underneath the textbox will show the available characters in the line USER INFORMATION You have entered DR X When both lines have been entered a confirmation screen will show your selection with an option to ACCEPT YES will take you back to the main Setup Menu NO will take you back to the first USER INFORMATION screen ACCEPT NO 6 Technical Notes 6 1 Performance Test Before operating and using the device a performance test must be carried out at e Short circuit the needle connector and the ECG connector the site of use The performance test described below is in compliance with the The following screen should appear on the display German 5 MPBetreibV directive eo a 0 00mA 0 01mA e Insert the batteries and switch on the device ye 0 00uc Le ol l The following screen should appear on the display 7 HA ALAVANT e
20. eriod of time to prevent leakage WARNING If battery acid has leaked into the device essential circuitry may have been compromised In the event of leakage the device must be returned to its manufacturer for safety checks and possible repairs 1 3 Device Layout Cable Connector e Insert the Nerve Locating Cable the combined Nerve Mapping Locating Cable or the NMBA cable to activate the relevant mode Multi Functional Clip l Enter Frequency Button e Press to toggle between Frequencies e Press to Enter in setup menu Menu Pulse Width Button NMS410 450 LOC MAP Mode e Press to toggle between Pulse Widths e Press and hold to access Setup Menu NMS 450 NMBA Mode e Press to toggle between Stimulation Modes gee I I I 1 I I L I I I I Stimulating LED indicator e Flashing Green Stimulus delivered e Flashing Red Open Circuit Pause Button NMS 410 450 LOC MAP Mode e Press to Stop Start Stimulation NMS 450 NMBA Mode e Press and release to elicit a single stimulation e Press and hold to activate a repeated stimulation The Wheel e Adjust current in the main operating mode e Navigate the Setup Menus On Off Button e Press to switch unit on off _ _ _ _ _ _ _ _ _ 1 4 Screen Layout Indicators LOC MAP MBA eZ VA x 4 lt 4 E h Nerve locating mode Nerve mapping mode NMBA m
21. erve mapping mode and start monitoring the needle patient connection again Whenever the nerve mapping probe and the nerve locating needle simultaneously make contact with the patient the needle will have first priority e This mode is selected when the Nerve Mapping Locating cable is inserted When using the Nerve Mapping Probe NMS 410 450 e The STIMPOD will automatically default to the Nerve Mapping current range 0 20mA and display the WEN indicator 3 1 Adjusting the Current ___ Current Range 0 20mA adjustable in 1mA increments Circle the Wheel to adjust current 3 2 Adjusting the Pulse Width Options in the Setup Menu 0 05ms 0 1ms 0 3ms 0 5ms 1ms Default 0 1ms 0 3ms Press Menu Pulse Width button to toggle between different pulse widths When using the Nerve Locating Needle Sound If sound is enabled STIMPOD will beep every time that a stimulus was delivered The pitch of the sound will follow the current intensity level TY Zin A o 1 0 2m A Average of actual current delivered Warning Notifies the user of a discrepancy between current setting and average current of actual stimulus 3 3 Adjusting the Twitch Frequency Options in the Setup Menu 1Hz 2Hz 5Hz Default 2Hz Press Enter Hz button to toggle between different stimulating frequencies e Connect the needle to the Nerve Mapping Locating cable The moment that the needle penetrates the skin the cable will commu
22. es than the recommended separation distance 80MHz 2 5GHz Contents 3 1 3 2 5 9 Getting to know the STIMPOD NMS 410 450 Device Description Accessories Device Layout Screen Layout Warning Screens Open Circuit Detection Auto Shutdown Symbols on device battery clip Operating Device in Nerve Locating Mode NMS 410 450 Proximity Indicator Adjusting the Current Adjusting the Pulse Width Adjusting the Twitch Frequency Operating Device in Nerve Mapping Locating Mode NMS 410 450 Adjusting the Current Adjusting the Pulse Width Adjusting the Twitch Frequency Operating Device in Neuromuscular Blocking Agent NMBA Monitoring Mode NMS 450 Electrode Placement Accelerometer Placement Adjusting the Current Adjusting Stimulation Mode Adjusting the Twitch Tetanus Frequency Page NAA WU BPWN e CO CO WON 10 10 10 11 11 12 12 12 4 6 4 7 4 8 4 9 4 10 4 11 4 12 Ss Ne Noe Nor SS 5 1 Dae De 5 4 5 9 2 6 Sal ope 3 9 5 10 sxe Neo Neo No No No No No Nor 6 1 6 2 6 3 Train of Four Mode TOF Double Burst Mode DB Post Tetanic Count Mode PTC Refractory Period Delay Twitch Mode Tetanus Mode Single Stimulus vs Repeated Stimulation Setting up Device Defaults Languages Current Mode Pulse Width Options Stimulating Frequency Repeat Timer TOF DB PTC NMS450 Refractory Period Timer TOF DB PTC NMS450 Proximity Ind
23. g ECG electrodes may cause superficial The Stimpod is designed to be compatible with a standard ECG electrode how ever for high currents the use of a dedicated NMBA electrode such as the Xavant XT45008 NA is recommended Electrodes that have current densities exceeding 2mA cm may require special attention of the operator This product must be stored at 0 50 C This product must be transported in the carry case provided This product and all the accessories have been certified latex free Warranty The Stimpod device only carries a 24 Month Warranty against defects provided that the device was used in accordance with the operating instructions The cables included in the Stimpod Kit carry a 6 Month Warranty against defects provided that they were used in accordance with the operating instructions The Stimpod enclosure should not be opened under any circumstances Opening the unit will void the warranty STIMPOD NMS410 450 conforms to the following standards IEC 60601 1 IEC 60601 2 10 IEC 60601 1 2 CISPR 11 Group class A IEC 61000 4 2 IEC 61000 4 3 ISO 13485 Directive 93 42 EEC Guidance and manufacturers declaration electromagnetic emissions for all equipment and systems The STIMPOD NMS410 NMS450 is intended for use in electromagnetic environment specified below The customer or user of the STIMPOD NMS410 NMS450 should assure that it is used in such an environment Emission Test Electromagnetic E
24. icator Speaker Volume Backlight User Information Technical Notes Performance Testing Specifications Cleaning and Disinfecting STIMPOD Products amp Accessories Page 12 13 13 13 14 14 14 15 15 16 18 18 18 12 19 20 20 20 21 21 23 23 24 1 Getting to know the STIMPOD NMS 410 450 1 1 Device Description The STIMPOD NMS 410 450 is a precision nerve locating tool used for localizing specific neural pathways Localization of nerves by electrical stimulation involves connecting the nerve stimulator to a conducting needle through which local anaesthetics can be injected The distance of the needle cathode from the nerve can be estimated by establishing the minimum threshold current required to facilitate a neuromuscular response The STIMPOD NMS 450 includes Neuromuscular Blocking Agent Monitoring functionality with real time feedback achieved by tri axial accelerometry CAUTION This device should only be used by a qualified physician with appropriate knowledge in anaesthesia CAUTION The sale or purchase of the device is restricted to licensed medical practitioners as governed by the law of the country state in which he she practices or where the device is to be used 1 2 Accessories WARNING Use of cables or other accessories other than those supplied with the STIMPOD may result in serious injury NOTE Electrodes and Nerve Locating needles are not included in this package CAUTION
25. ing wheel and slowly increase the current to 20mA e Monitor that the stimulating waveform measured and displayed in the diagnostic window is square The top part of the square wave should also touch the dotted line which represents the current setting as shown below In order to test the Nerve Locating connection and device functionality follow the instructions in 6 1 1 6 1 3 Neuromuscular Blocking Agent Mode NMBA Mode NMS450 only e Insert the NMBA Cable The following screen should appear on the display 00OmA 0 A Open Circuit Detected TOF e Ensure that the device is in TOF mode e Short circuit the red and black electrode connectors DED o E 00m UA e Use the adjusting wheel and increase the current to 80mA e Press the play pause button while shaking the accelerometer The NMS450 should respond as follows e The LED should flash GREEN in accordance with the four stimulations e Each stimulation should be accompanied by an audible beep e In Diagnostic window four bars of different heights should indicate that the accelerometer detected movement e Monitor the actual current delivered to ensure that the warning sign does not appear 80m ays Sih ALLL 00 e Separate the red and black electrode connectors to cause an open circuit between them e Press the play pause button The following screen should appear on the display 00OmA 0 i A
26. ings Press enter to accept the desired setting Noa V NGO A Man smk as A confirmation screen will show your updated values with You have selected an option to ACCEPT 04 10 YES will take you back to the main Setup Menu NO will take you back to the previous screen ACCEPT NO 5 7 Proximity Indicator DEFAULT 30 60 nC The proximity indicator notifies the user that the target charge range has been reached This function allows the user to set up an upper and lower limit of charge When contraction is elicited this indicator should indicate to the user that the needle has reached the desired proximity to the nerve This proximity is indicated both visually and audibly Visually In the diagnostics screen of the device the dotted line will indicate the selected current level The proximity range will be indicated by two arrowheads on the right hand side of the diagnostics screen The arrow representing the lower thresh old value will point up and the arrow representing the higher threshold value will point down This offers the user visual feedback on the position of the current amplitude at a specific pulse width relative to the defined proximity thresholds NOTE The proximity thresholds are defined in charge Coulomb Audibly The STIMPOD has three different sound patterns when stimulating A single beep means that the user is above the upper threshold of the proximity range A dou ble beep means that the user
27. is in the proximity range A triple beep means that the user is below the proximity range To change the default Proximity Indicator Levels use the On Wheel to navigate to PROXIMITY INDICATOR in the main ERMENI menu Press enter to select Choose On or Off by activating SS the correct radio button To exit scroll down the menu to EXIT MENU and press enter ROAN A confirmation screen will show your selection with an You have selected option to ACCEPT On YES will take you to the following menu ACCEPT NO NO will take you back to the menu above PROXIMITY INDICATOR Adjust Proximity Thresholds Here you have the option to adjust the proximity thresholds YES will take you to the thresholds adjustment menu NO will take you back to the main Setup Menu NO encore ANONRA The lower limit will be highlighted Adjust using the Adjust Range adjusting wheel Press enter to move on to the upper limit Low Ef nc Adjust the upper limit and press enter High 60 nC NR 9 ee ance Nm AINN Ke S A confirmation screen will show your updated values with You have selected an option to ACCEPT 30 nC 60 nC YES will take you back to the main Setup Menu NO will take you back to the previous screen ACCEPT NO 5 8 Speaker Volume DEFAULT Medium The speaker volume offers 4 different options OFF and 3 different volume settings The different volume settings are indicated on the main screen as follows Off x Low K
28. istered This procedures involves subcutaneous stimulation of the motor component of the relevant peripheral nerve to locate the nerve e Select this mode by inserting the Nerve Locating cable e The STIMPOD will automatically default to the Nerve Locating current range 0 00 5 00 mA and display the Rd indicator 2 1 Proximity Indicator The proximity indicator is activated when the combination of current and pulse width settings result in a charge which Is within the range as selected in the SETUP MENU section 5 7 Visual Indication e Visually indicated in the diagnostics screen by two arrowheads e Arrowhead indicating the lower threshold points upwards e Arrowhead indicating the upper threshold points downwards e The dotted line representing the selected current will be positioned between the two arrowheads If the target charge range is entered Audible Indication e A successful stimulus above the proximity range will make a single beep e A successful stimulus within the proximity range will make a double beep e A successful stimulus below the proximity range will make a triple beep 2 2 Adjusting the Current Current Mode Options Options in the Setup Menu Linear Mode Non Linear Mode Default Linear Linear Mode VA The Linear Mode is called linear because one click on the Wheel will correspond with one increment as set in the specific current range The Linear Mode allows the user to select i
29. k to the previous screen ACCEPT NO 5 5 Repeat Timer TOF DB PTC NMS450 DEFAULT 2 minutes for all three modes Options Adjustable from 00 00 to 99 59 This timer counts down the delay between repeated stimulations in TOF DB and PTC modes when operating the device in NMBA mode Minutes will be highlighted Use the Wheel to adjust eC the settings Press enter to accept the desired setting Adjust Range Minutes MYM Seconds will be highlighted Use the Wheel to adjust Seconds 20 the settings Press enter to accept the desired setting A confirmation screen will show your updated values with You have selected an option to ACCEPT 01 20 YES will take you back to the main Setup Menu NO will take you back to the previous screen ACCEPT NO 5 6 Refractory Period Timer TOF DB PTC NMS450 DEFAULT TOF 15 seconds DB 1 minute PTC 2 minutes Options Adjustable from 00 00 to 99 59 These three individual timers count down the refractory period delays for the three modes TOF DB PTC respectively Their purpose is to prevent the user from repeating stimulation while the nerve synapse is recovering from the effects of the previous stimulation Minutes will be highlighted Use the Wheel to adjust SENS ROM TRO the settings Press enter to accept the desired setting Adjust Range Minutes WYJ Seconds will be highlighted Use the Wheel to adjust Seconds 10 the sett
30. ld be at least 30 Power frequency 50 60 Hz 3 A m 50 Hz Power frequency magnetic fields should be at levels characteristic of a typical magnetic field 3 A m Effective location in a typical commercial or hospital environment IEC 61000 4 8 Guidance and manufacturer s declaration electromagnetic immunity The STIMPOD NMS410 NMS450 is intended for use in the electromagnetic environment specified below The customer or the user of the STIMPOD NMS410 NMS450 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 STIMPOD NMS410 NMS450 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 Not applicable IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m 3 V m d 1 2 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz 25 soeeeeeen where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equi
31. n this range CHOOSEINCREMENTS the user can select one of the following increment x Pig options 0 05mA 0 1mA and 0 2mA The default setting is 0 1mA Select the desired increment and proceed to O 0 2 NEXT RANGE RANGE 2 0 5 0mA The third range will be 2 0mA 5 0mA In this range CHOOSE INCREMENTS the user can select one of the following increment z a options 0 1mA 0 2mA and 0 5mA The default setting i is 0 2mA Select the desired increment and proceed to O 0 5 EXIT MENU LINEAR MODE A confirmation screen will show your selection with an You have selected option to ACCEPT 0 0 0 6mA 0 01 0 6 2 0mA 0 05 YES will take you back to the main Setup Menu 2 0 5 0mA 0 1 i NO will take you back to Linear Mode settings ACCEPT NO Non Linear Mode The L indicator in the main menu window tells the user that the device is in Non Linear Mode The Non Linear Mode facilitates the non linear nature of the current intensity versus the distance from the nerve The required current intensity is proportional to the square of the distance from the electrode to the nerve fibre This mode allows the user to define 20 adjustment positions in terms of Current mA and Pulse Width ms If correctly implemented each adjustment position should afford the user a relatively linear progression in terms of the distance from needle tip to the nerve The defaults are indicated in table 5 1 A graph of table 5 1 is shown in figure 5
32. ndividual incrementing options for the three different current ranges Default Current range 0 00 5 00mA adjustable in the following default increments 0 0 0 6mA Default 0 1mMA 0 6 2 0mA Default 0 2mA 2 0 5 0mA Default 0 5mA Increments can be adjusted in the Setup Menus refer to 5 2 Circle the Wheel to adjust current Warning Notifies the user of a discrepancy between current _ setting and average current of actual stimulus Average of actual current delivered 2 3 Adjusting the Pulse Width lt Options in the Setup Menu 0 05ms 0 1ms 0 3ms 0 5ms 1ms Default 0 1ms 0 3ms Press Menu Pulse Width button to toggle between different Pulse Widths Sound If sound is enabled STIMPOD will beep every time that a stimulus was delivered The pitch of the sound will follow the current intensity level Non Linear Mode L The Non Linear Mode facilitates the non linear nature of the current intensity versus the distance from the nerve This mode allows the user to define 20 adjustment positions in terms of Current mA and Pulse Width ms If correctly implemented each adjustment position should afford the user with a relatively linear progression in terms of the distance from needle tip to the nerve Default Current and Pulse Width Range As shown in table 5 1 in section 5 2 circle the Wheel to select the predetermined current and pulse width positions sequentially NOTE Because the 20 definable positions
33. nicate this to the STIMPOD switch to nerve locating mode and switch the stimulation to the needle The current in locating mode will default to 0 00mA e The STIMPOD will now function exactly as described in Chapter 2 e f contact between the needle and patient is broken and the nerve mapping probe touches the patient STIMPOD will switch back to the nerve mapping mode and start monitoring the needle patient connection again Mapping mode will default back to OmA e Whenever the nerve mapping probe and the nerve locating needle simultaneously make contact with the patient the needle will have first priority 4 Operating Device in Neuromuscular Blocking Agent Monitoring Mode NMS 450 Monitoring Neuromuscular Blocking Agents involves stimulating a neural pathway which facilitates the contraction of an appendage Based on the relative strength of contraction which is the result of a stimulus of specific intensity or waveform it is possible to draw conclusions about the efficacy of an injected Neuromuscular Blocking Agent e This mode is selected when the NMBA cable is inserted 4 1 Electrode Placement 4 1 1 Anatomical stimulation sites are chosen based on e their accessibility during surgery e the ability to observe the neuromuscular response e the nerve should be a suitable distance from the responding muscle to prevent direct muscle stimulation 4 1 2 Anatomically ideal stimulation sites Targeted Nerve Affecte
34. nvironment Guidance RF Emissions Group 2 Class A The STIMPOD NMS410 NMS450 must emit electromagnetic energy in order CISPR 11 to perform its intended function Nearby electronic equipment may be af fected The STIMPOD NMS410 NMS450 is suitable for use in all establishments other than domestic establishments and may be used in domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes provided the following warning is heeded WARNING This equipment system is intended to be used by healthcare professional only This equipment system may cause radio interference or disrupt the operation of nearby equipment It may be necessary to take mitigation measures such as re orienting or re locating the STIMPOD NMS410 NMS450 or shielding the location Guidance and manufacturers declaration electromagnetic immunity for all equipment and systems The STIMPOD NMS410 NMS450 is intended for use in the electromagnetic environment specified below The customer or the user of the STIMPOD NMS410 NMS450 should assure that it is used in such an environment Immunity Test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD 6 kV contact 6kV contact Floors should be wood concrete or ceramic tile If the floors are covered with IEC 61000 4 2 8 kV air 8kV Air synthetic material the relative humidity shou
35. ode NMS450 Non Linear mode Linear mode Ti Volume Battery Status eee if Ee o a ae _ g Z l S A Warning Main Screen Notifies the user of a discrepancy e Current Setting between current setting and average Adjust using Wheel current of actual stimulus e Diagnostic or Warning Screen Average current of actual stimulus Warning Screens e Pulse Width Setting Explained P 5 xplained on Page 5 Adjust using Menu Pulse Width button e Stimulating Frequency Setting e NMBA Mode NMS 450 Adjust using Enter Hz button Stimulation Mode TOF DB PTC TET TWIL _ Diagnostic Screen NMS 410 450 LOC MAP Mode Diagnostic Screen NMS 450 NMBA Mode e Calculated e Countdown timer e Proximity indicator arrow _ Charge e Real time feedback of for repeat mode T Setting relative contraction strength measured with the accelerometer e Graph indicating shape of j e Average charge of e Calculated percentage in TOF and DB mode actual current stimulus actual stimulus e Twitch Count in PTC and TOF if less than 4 contractions i were indentified 1 5 Warning Screens Insert Cable AN Insert Cable This is the first prompt which the user will encounter as the unit is switched on and signals that the unit is waiting for the cable to be inserted Pause This warning informs the user that the PAUSE button was pressed AN PAUSE The STIMPOD will pause all its activities and wait for the P
36. pment marked with the following NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection 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 STIMPOD NMS410 NMS450 is used ASST the applicable RF compliance level above the STIMPOD NMS410 NMS450 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the STIMPOD NMS410 NMS450 Recommended separation distances between portable and mobile RF communications equipment and the STIMPOD NMS410 NMS450 The STIMPOD NMS410 NMS450 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the STIMPOD NMS410 NMS450 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the STIMPOD NMS410 NMS450 as recommended below
37. ractions could be measured the percentage of measured contraction strength of the fourth stimulus compared to the first stimulus will be displayed in the diagnostic screen e f less than four contractions were measurable the number of contractions that could be identified by the accelerometer will be displayed e g 2 4 4 7 Double Burst Mode DB The DB stimulation comprises a burst of three square waves of 200 microseconds pulse width 20 milliseconds apart followed by another burst of three square waves 750 milliseconds later Selecting DB Mode e Insert the NMBA cable with the red and black electrode clips as well as the tri axial accelerometer e Press the Mode button until DB is shown on the display ia o ab Real time Accelerometry 20 mA 20 0mA e The relative contraction strength caused by each stimulus is indicated graphically in the diagnostic screen as 00 36 100 shown in the picture DB e The percentage of the measured contraction strength of the second contraction compared to the first contraction will be displayed in the diagnostic screen 4 9 Refractory Period Delay 4 8 Post Tetanic Count PTC Defaults Tetanus 50Hz for 5 seconds Delay 3 seconds Twitch 20 twitches at 1Hz The PTC stimulation comprises a tetanus stimulation followed by a delay and a number of twitches Default settings are as shown above Selecting PTC Mode e Insert the NMBA cable with the red and
38. rrent Pi 4 4 Adjusting Stimulation Mode Options TOF DB PIG TET TWI Default TOF Press Menu Mode button to toggle between different Stimulation Modes 4 5 Adjusting Twitch Tetanus Frequency Twitch Mode Options in the Setup Menu Stimulating Frequency 1Hz 2Hz 5Hz Default 2 Hz Press Enter Hz button to toggle between different stimulation frequencies Tetanus Mode TWI Fir Options 50Hz 100Hz Default 50Hz Press Enter Hz button to toggle between different stimulating frequencies Sound If sound is enabled STIMPOD will beep every time that a stimulus was delivered The pitch of the sound will follow the current intensity level ia o in A 20 0mA 00 36 Average of actual current delivered Warning Notifies the user of a discrepancy between current 1 0 0 setting and average current of actual stimulus 4 6 Train of Four Mode TOF The TOF stimulation comprises four square waves with a pulse width of 200 microseconds 500 milliseconds apart Selecting TOF Mode e Insert the NMBA cable with the red and black electrode clips as well as the tri axial accelerometer e Press the Mode button until TOF is shown on the display Ea o ih 20 M 20 0ma Real time Accelerometry e The relative contraction strength LLL 100 0 caused by each stimulus is indicated 1 00 o graphically in the diagnostic screen as TOF shown in the picture e In the case that all four cont
39. t Timer for each mode defaults at 2 minutes and can be changed in the menu 5 Setting up Device Defaults NMS 410 450 Access the Setup Menu by pressing and holding the Menu Pulse Width Button The setup menu allows the user to customise all the default settings SETUP MENU LANGUAGE CURRENT MODE PULSE WIDTH FREQUENCY REPEAT TIMER TOF REPEAT TIMER DB REPEAT TIMER PTC REFRACTORY TIME TOF REFRACTORY TIME DB 10 REFRACTORY TIME PTC 11 PROXIMITY INDICATOR 12 SPEAKER VOLUME 13 BACKLIGHT 14 USER INFORMATION EXIT WONAUBWN Note The NMS410 does not have the REPEAT TIMER or REFRACTORY TIMER options 5 1 Languages DEFAULT English Use the Wheel to navigate to LANGUAGE Press enter to select To select another default language use the Wheel to English navigate to the preferred language Press enter to select pei dea The radio button next to the selected language will show that it is activated To exit scroll down the menu to EXIT O Nederlands O Espa ol MENU and press enter LANGUAGE A confirmation screen will show your selection with an You have selected option to ACCEPT English YES will take you back to the main Setup Menu NO will take you to the previous screen ACCEPT NO 5 2 Current Mode DEFAULT Linear Mode Options Linear Mode Non Linear Mode Linear Mode The VA indicator in the main window tells the user that the device is in Linear Mode The linear mode is called line
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