Xavant StimPod NMS450X+ Instructions For Use Manual
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Xavant StimPod NMS450X+ Instructions For Use Manual

Quantitative nmt monitor precision nerve locator
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Quantitative
Precision Nerve Locator
Instructions for Use
Software Version 10.6x
NMT Monitor
XM400-21ENP04-02
December 2023
1

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Summary of Contents for Xavant StimPod NMS450X+

  • Page 1 Quantitative NMT Monitor Precision Nerve Locator Instructions for Use Software Version 10.6x XM400-21ENP04-02 December 2023...
  • Page 2 Sponsors Indications for use Australia This product is a nerve stimulation device designed to be used by an anaesthetist during Xavant Technology (Pty) Ltd • Teleflex Medical Australia General Anaesthesia, for the purpose of establishing the efficacy of a Neuromuscular...
  • Page 3 For acceleromyography, the STIMPOD is designed to be compatible with standard ECG will void the warranty. electrodes, however, for high currents the use of a dedicated NMT electrode such as the Xavant XT45008 is recommended. • STIMPOD NMS450X+ Conforms to The Following Standards: Electrodes that have current densities exceeding 2mA/cm2 may require special attention of the operator.

  • Page 4: Table Of Contents

    Contents 1 | Getting to Know the STIMPOD NMS450X+ 3.6 | EMG Patient Setup ......... . . 21 3.7 | Adjusting the Current .

  • Page 5: Getting To Know The Stimpod Nms450X

    Getting to Know the STIMPOD NMS450X+ 1.1 | Device Description The STIMPOD NMS450X+ is a quantitative Neuromuscular Transmission (NMT) monitor the subcutaneous location of a nerve - indicated as the specific point beneath the surface of utilizing either tri-axial accelerometry or electromyography to provide real-time quantitative the skin where the lowest threshold current required to elicit a neuromuscular response to feedback.

  • Page 6: Device Layout

    1.2 | Device Layout Cable Connector Insert the combined Nerve Mapping/ Locating Multi Functional Clip Cable or the NMT cable to activate the relevant mode. Display Screen Full colour LCD display with capacitive touch and dimmable backlight control. Right Function Key Context sensitive selection key - corresponds with buttons on the display that are blue in colour.

  • Page 7: Screen Layout

    1.3 | Screen Layout Electrode Placement Control Reference Indicator Indicates location and placement of stimulation Indicates that a stimulation reference value has and Monitoring electrode/s - Tap to set electrode been acquired and stored location. Device Settings Control Open/Closed Circuit Indicator Indicates speaker volume &...

  • Page 8: Accessories

    • The AMG cable is used to enable AMG based NMT Monitoring on the STIMPOD. • The red (anode) and black (cathode) connectors are designed to clip onto the Xavant NMT electrode (XT-45008) or onto a standard ECG electrode. •...
  • Page 9 EMG Accessories (STIMPOD NMS450X+) NMT Monitoring Cable EMG 1 8m (XT-45003) and 3 5m (XT-45003A): • The EMG cable is used to enable EMG based NMT Monitoring on the STIMPOD. • The EMG cable connects directly to the EMG Electrode. EMG Electrode Large (XT-45009L) and Small (XT-45009S): •...

  • Page 10: Warnings & Information Messages

    1.5 | Warnings & Information Messages Abnormal NMT Data This warning message is displayed during NMT modes of Abnormal NMT Data Warning and information messages are raised on the display screen in response to a given error operation when sensor data has not been received or is corrupted, or when the TOF/DB Ratio exceeds 150%.

  • Page 11: Shutdown Warning Messages

    1 5c Shutdown Warning Messages 1 5d General Warning Messages These messages are raised on the main display screen in response to a safety concern or These messages are raised on the display screen in response to operational conditions and will condition of the device that requires operator intervention, and remains on the display screen for remain in view until the condition that triggered the message is removed.

  • Page 12: Open / Closed Circuit Detection

    1.7 | Auto Shutdown 1.6 | Open / Closed Circuit Detection The STIMPOD performs impedance measurements at regular intervals to detect whether the STIMPOD will shut down after 10 minutes of no user or patient interaction. connection between the STIMPOD and the patient comprises a closed circuit. 1.8 | Symbols Closed Circuit Detected: •...

  • Page 13: Nerve Locating/Mapping Nms450X

    Nerve Locating/Mapping NMS450X+ Locating Mode (LOC) Localisation of nerves by electrical stimulation involves connecting the nerve stimulator to a • Select this mode by inserting the Nerve Locating / Mapping cable. conducting, locating needle (not supplied) through which local anaesthetics can be administered. •...
  • Page 14 When Using the Nerve Locating Needle LOC Mode Indicator Device Settings Control Indicates Loc Mode when the Mapping/Locating If enabled, the speaker will beep each time a cable is connected and the stimulation needle is in stimulus is delivered. The pitch of the beep will contact with patient skin.
  • Page 15 Mapping Mode (MAP) Transcutaneous nerve mapping enables the anaesthesiologist to map out a particular This mode offers the user the means to do nerve mapping and locating without having to switch superficial nerve prior to nerve location with the needle. This is accomplished by stimulating or unplug cables.

  • Page 16: Adjusting Current In Loc And Map

    2.1 | Adjusting Current in LOC and MAP 2.3 | Adjusting the Stimulation Frequency The stimulation current in LOC and MAP mode can be adjusted in predefined increments by Options: 1Hz, 2Hz, 5Hz using the left and right function keys or the scroll wheel on the keypad. Default: 2Hz Tap on the Pulse Settings Control icon on the display screen to select the desired stimulation frequency from a list of supported frequency settings.

  • Page 17: Neuromuscular Transmission (Nmt) Monitoring Nms450X

    These stimulation modes are available for use when a Xavant manufactured NMT Monitoring NMBA changes - making it an effective means for assessing the degree of neuromuscular cable is connected to the STIMPOD.

  • Page 18: Cables And Sensors For Nmt Monitoring

    3.2 | Cables and Sensors for NMT Monitoring 3.3 | Stimulation Sites for NMT Monitoring The STIMPOD NMS450X+ makes provision for two different sensor technologies for NMT The stimulation electrode should be placed so that the cathode terminal (black in colour) is Monitoring namely Acceloromyography (AMG) and Electromyography (EMG).

  • Page 19: Verifying Electrode Placement

    3.4 | Verifying Electrode Placement • Tap on the Open/ Closed Circuit control icon, when a closed circuit condition occurs in NMT Mode, for visual guidance on correct placement of electrodes: AMG Electrode EMG Electrode Placement Placement • Tap on the Open/Closed Circuit control icon, when an open circuit condition occurs in NMT Mode, for visual guidance on where the open circuit condition has been detected.

  • Page 20: Amg Patient Setup

    3.5 | AMG Patient Setup Check Batteries & Switch Device On Connect NMT Monitoring Cable AMG Prepare Patient’s Skin for Monitoring Power on device Patient Setup Attach Electrodes RECORD ID: P0000 CLOSE START CASE Connect Clips to the Electrodes Setup Ready Attach Accelerometer to Appropriate Contracting Appendage 20 |...

  • Page 21: Emg Patient Setup

    3.6 | EMG Patient Setup Check Batteries & Switch Device On Connect NMT Monitoring Cable EMG Prepare Patient’s Skin for Monitoring Power on device Patient Setup Attach EMG Electrode to Patient RECORD ID: P0000 CLOSE START CASE 2-3 cm proximal to wrist crease Setup Ready Connect EMG Electrode to the NMT Monitoring Cable EMG...
  • Page 22 When using the NMT Mode NMT Main Screen Electrode Placement Control Reference Indicator Indicates location and placement of stimulation Indicates that a stimulation reference value has and Monitoring electrodes - Tap to set and view been acquired and stored. Results in TOF, DB, PTC, the electrode placement.

  • Page 23: Adjusting The Current

    3.7 | Adjusting the Current 3.8 | Adjusting Stimulation Mode Default Current Range: 0 - 80 mA Stimulation Mode: Auto, TOF, PTC, SMC, TWI, TET, DEP and DB Use the scroll wheel on the keypad or the current setting control on the display screen to adjust Default: Auto current.

  • Page 24: Refractory Period Delay

    3.9 | Refractory Period Delay 3.10 | Single Stimulus vs. Repeated Stimulation A minimum delay period must be observed between any two consecutive stimulation patterns in A repeat stimulation sequence automatically initiates a TOF, DB, PTC or DEP stimulation pattern the TOF, DB and PTC stimulation modes.

  • Page 25: Adjusting Quick Timers

    3.11 | Adjusting Quick Timers 3.12 | Adjusting Twitch / Tetanus Frequency Applicable Stimulation Modes: Auto, TOF, PTC, DEP, DB Frequency Setting Control The Default value for each applicable stimulation mode is set in the NMT menu. In the Twitch and Tetanus Stimulation Modes Tap on the timer Settings Control icon to select the repetition period from a list of available options.

  • Page 26: Auto Mode

    • 3.13 | Auto Mode If an SMC value cannot be determined the current setting defaults to 60mA ,or 30mA if the facial nerve is stimulated, and the following warning message is displayed. Auto mode is used to conduct Full Case NMT Monitoring. This is achieved through a series of alternating TOF and PTC stimulation sequences to determine the depth-of-block throughout the duration of the procedure.
  • Page 27 • 2. Monitoring a Case Swipe left over the display area at any time to view the depth of block trend graph. • The AUTO mode will commence with a series of alternating TOF and PTC stimulation sequences to determine the depth-of-block throughout the duration of the case. Depth of Block (DOB) •...
  • Page 28 • If an EMG monitoring cable is being used, the CMAP waveforms for each of the evoked 3. Closing a Case • responses measured during TOF and PTC stimulations can be seen by swiping left over The Auto Mode is paused when the pause/play key on the keypad is pressed or an open the graph area.

  • Page 29: Train Of Four Mode (Tof)

    3.14 | Train of Four Mode (TOF) 3.15 | Post Tetanic Count (PTC) Evoked Response & Waveform Display Window Evoked Response & Waveform Display Default View: Evoked Response Magnitude Window for each stimulation pulse. Default View: Evoked Response Magnitude for each stimulation pulse. NMT Result Type Indicator NMT Result Type Indicator TOF-R: Displayed when 4 evoked...

  • Page 30: Supra Maximal Current (Smc)

    3.16 | Supra Maximal Current (SMC) 3.17 | Twitch (TWI) Current Settings Control SMC Value: 0 - 80mA. Changes to the calculated SMC value upon completion of the SMC stimulation pattern. Evoked Response & Waveform Display Evoked Response & Waveform Display Window Window Default View: Evoked Response...

  • Page 31: Tetanus (Tet)

    3.18 | Tetanus (TET) 3.19 | Depolarising Muscle Relaxant Monitoring (DEP) Evoked Response & Waveform Display Window Default View: Evoked Response Magnitude for each stimulation pulse. Reference Level Indicator Indicates Magnitude of measured reference value. NMT Result Type Indicator T1/T : Displayed when all 4 evoked responses Evoked Response &...

  • Page 32: Double Burst Mode (Db)

    3.20 | Double Burst Mode (DB) Evoked Response & Waveform Display Window Default View: Evoked Response Magnitude for each stimulation pulse. NMT Result Type Indicator DB-R: Displayed when 2 evoked responses are available. DB-R = (T2/T1)×100% DB-R NMT Numerical Result DB-R: 0 - 100%.

  • Page 33: Setting Up Device Defaults

    Settings (with MAP/LOC Cable Connected). Recorded NMT Case Files Tap to access and view recorded NMT case files. User Information Tap to access and change user specific information and settings. Xavant University Tap to access scannable QRCode link to Xavant University.
  • Page 34 Refractory Timer Settings Auto Timer Settings Tap on the Refractory Timers menu item to preset the default refractory timer setting for the TOF, Tap on the Auto Timers menu item to preset the default repeat timer setting that will be observed DB and PTC stimulation patterns.
  • Page 35 4 2 2 MAP/LOC Settings 4 2 3 Recorded NMT Case Files MAP/LOC settings are only accessible when the MAP/LOC stimulation cable is plugged into the Tap on the Recorded Case Files icon on the main menu to access and view recorded NMT Data. STIMPOD NMS450X+.
  • Page 36 Tap on a case file for a graphical view of the recorded case data. The full complement of case files can be downloaded from the STIMPOD NMS450X+ to an external computing device through the use of a Xavant manufactured data cable. Instructions for downloading the case files are provided with the data cable.
  • Page 37 • 4 2 4 | User Information Construct a User ID text string by selecting alphanumeric characters from the character set. • Tap on the User Information icon on the main menu to access, view and change user related Tap on the left and right arrows to navigate through the alphanumeric character set and information recorded by the STIMPOD NMS450X+.

  • Page 38: Technical Notes

    Technical Notes 5.1 | Performance Test 5 1 1 | Nerve Locating Mode • Insert the Nerve Mapping/Nerve Locating Cable. Before operating and using the device a performance test must be carried out at the site of use. The following screen should appear on the display. The performance test described below is in compliance with the German §...
  • Page 39 • Short-circuit the needle connector and the ECG connector. The following screen should appear on the display. • The LED should flash RED and no audible feedback should be heard. • Short-circuit the Nerve Mapping probe and the ECG connector. The following screen should appear on the display.
  • Page 40 The NMS450X+ should respond as follows: 5 1 3 | NMT Monitoring Mode (AMG) • The LED should flash GREEN in accordance with the four stimulations. • • Each stimulation should be accompanied by an audible ‘beep’. Insert the NMT Monitoring Cable (AMG). •...
  • Page 41 5 1 4 | NMT Monitoring Mode (EMG) The NMS450X+ should respond as follows: • • Insert the NMT Monitoring Cable (EMG). The LED should flash green and if sound is enabled in the menu a ‘beep’ should be heard The following screen should appear on the display.

  • Page 42: Specifications

    5.2 | Specifications Stimulation Settings Stimulus NMT Mode Nerve Mapping Mode Nerve Locating Mode Stimulus Type Current Controlled Current Controlled Current Controlled Stimulus Waveform Monophasic Square Wave Monophasic Square Wave Monophasic Square Wave Stimulus Pulse Width 200µs ± 5% 50μs, 100μs, 200μs, 300μs, 500μs, 1ms ± 5% 50μs, 100μs, 200μs, 300μs, 500μs, 1ms ±...

  • Page 43: Guidance And Manufacturers Declaration

    5.4 | Guidance and Manufacturers Declaration Guidance and Manufacturers Declaration – Electromagnetic Emissions– for All Equipment and Systems The STIMPOD NMS450X+ is intended for use in electromagnetic environment specified below. The customer or user of the STIMPOD NMS450X+ should assure that it is used in such an environment.
  • Page 44 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The STIMPOD NMS450X+ is intended for use in the electromagnetic environment specified below. The customer or the user of the STIMPOD NMS450X+ should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment –...
  • Page 45 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the STIMPOD NMS450X+ The STIMPOD NMS450X+ is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the STIMPOD NMS450X+ can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the STIMPOD NMS450X+ as recommended below, according to the maximum output power of the communications equipment.

  • Page 46: Products & Accessories

    Products & Accessories Products & Accessories Product Code Products & Accessories Product Code STIMPOD NMS450X+ Kit XT-45030 Smart Data Cable NMShow - USB XT-45100A-NMS Smart Data Cable NMShow - RS232 XT-45100C-NMS Nerve Locating/Mapping Cable XT-41014 NMT Monitoring Cable AMG (1.8m) XT-45025 Smart Data Cable Philips - RS232 XT-45100C-PHI...

  • Page 47: Appendix A: Reporting Adverse Events To The Fda

    Appendix A: Reporting Adverse Events to the FDA Submitting Adverse Event Reports to FDA MedWatch is the Food and Drug Administration’s (FDA) program for reporting serious reactions, product quality problems, therapeutic inequivalence/failure, and product use errors with human medical products, including drugs, biologic products, medical devices, dietary supplements, Use one of the methods below to submit voluntary adverse event reports to the FDA at www.
  • Page 48 Unit 102, The Tannery Industrial Park, 309 Derdepoort Rd Silverton, Pretoria, South Africa, 0184 Tel: +27 (0) 12 743 5959, E-mail: support@xavant.com Web: www.xavant.com (01)06009880396115(10)xxxxxxxxxx...

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