natus XLTEK Protektor32 Instructions For Use Manual
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natus XLTEK Protektor32 Instructions For Use Manual

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  • Page 1 XLTEK Protektor32 Instructions for Use...
  • Page 3 Incorporated. The copyright and the foregoing restrictions on the copyright use extend to all media in which this information is preserved. This copy of the User Manual shall be used only in accordance with the conditions of sale of Natus Medical Incorporated or its distributors. Natus Medical Incorporated makes no representations or warranties of any kind whatsoever with respect to this document.

  • Page 5: Table Of Contents

    TABLE OF CONTENTS XLTEK Protektor32 Instructions for Use PROTEKTOR32 – INTRAOPERATIVE NEUROPHYSIOLOGICAL MONITORING ....6 Indications for Use ............................. 6 Protocols ................................6 SAFETY INFORMATION ........................7 Critical Warnings and Cautions ........................... 7 General Warnings .............................. 7 General Cautions .............................. 11 Audio/Visual Stimulation Warnings ........................
  • Page 6 Instructions for Use XLTEK Protektor32 RECOMMENDED USER PERFORMED MAINTENANCE .............. 33 Routine System Maintenance ..........................33 General User Performed Maintenance ......................33 Maintenance Warnings ............................. 33 Environmental Conditions ..........................34 Waste Management ............................34 PROTEKTOR32 SOFTWARE / EPWORKS ..................35 Setting Up Tests ..............................
  • Page 7 XLTEK Protektor32 Instructions for Use Creating Generic Reports ..........................72 REMOTE MONITORING ........................73 Before You Begin .............................. 73 XLTEK Portals ..............................73 LocalPortal ................................73 RemotePortal ................................73 Multiple Connections .............................. 74 Additional Information and Terms .......................... 74 TOOLBAR BUTTONS ........................... 76...

  • Page 8: Protektor32 - Intraoperative Neurophysiological Monitoring

    Instructions for Use XLTEK Protektor32 Protektor32 – Intraoperative Neurophysiological Monitoring Indications for Use The Protektor32 system, composed of both hardware and software, is intended to be used for intraoperative neurological Monitoring. The instrument uses EEG, EP, EMG and Transcranial Stimulation techniques (TcMEP) to provide the healthcare professionals with information to help assess a patient’s...

  • Page 9: Safety Information

    For further details on how to comply with this standard regarding non- Xltek supplied printers or VGA monitors, please consult the standard or contact Xltek Technical Support at 1-800-303-0306 or OTS@natus.com. WARNING: To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
  • Page 10 Instructions for Use XLTEK Protektor32 Operation in close proximity (for example 1 m) to shortwave or microwave therapy equipment may produce instability in the electrical stimulator output. The device is NOT intended to operate in the vicinity of strong sources of potential electromagnetic interference such as MRI or CT.
  • Page 11 XLTEK Protektor32 Instructions for Use Patient movement may occur during stimulation, leading to inadvertent neural injury. Take adequate steps to avoid stimulation when patient movement could cause injury. The Protektor32 shall be used ONLY with legally-marketed electrodes in the country where in use.
  • Page 12 Instructions for Use XLTEK Protektor32 Possible interference with signals may occur in certain situations (for example, poor grounding in circuitry and close proximity to other instrumentation such as an MRI). The accessories of this device may include several kinds of disposable, sterile electrode needles.

  • Page 13: General Cautions

    XLTEK Protektor32 Instructions for Use Do not install any other software than the EPWorks Software. Natus assumes no responsibility when the equipment is not used as described in this manual. Never touch the patient while connecting or disconnecting any connectors.

  • Page 14: Protektor32 With The Electro-Surgical Units (Esu) - Guidelines

    Instructions for Use XLTEK Protektor32 Only equipment approved to IEC950, IEC 60601-1 or a similar safety standard may be connected to the VGA port on the Protektor32. The final system must be configured to meet the requirements for safety of medical systems prescribed by IEC60601-1-1.

  • Page 15: Electrostatic Discharge (Esd) Handling Procedures And Warnings

    XLTEK Protektor32 Instructions for Use stimulation pulse duration ranges from 0.05 ms to 1.0 ms. Pulses are repetitive up to a maximum frequency of 500 Hz. Electrostatic Discharge (ESD) handling procedures and warnings Before performing any setup or placement procedures, it is recommended that all clinical staff read and/or are trained on the precautions outlined in this section.

  • Page 16: Protektor32 Safety And Standards Conformity

    Instructions for Use XLTEK Protektor32 Protektor32 Safety and Standards Conformity Essential Performance The potential sources of unacceptable risk identified to characterize the ESSENTIAL PERFORMANCE of EMG DIAGNOSTIC EQUIPMENT are: Minimum noise on a waveform or artifacts or distortion in an image and any error of a displayed •...
  • Page 17 XLTEK Protektor32 Instructions for Use IEC 60601-1-6: 2010 (Ed. 3.0) + A1: Medical electrical equipment - Part 1-6: General requirements 2013 for basic safety and essential performance - Collateral standard: Usability IEC 62366:2007 (Ed. 1.0) + A1: 2014 Medical devices – Application of usability engineering to...
  • Page 18 Instructions for Use XLTEK Protektor32 Table 2 – EMC Standard of Compliance and Normative References IEC 60601-1-2:2014 (Ed 4.0) Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance– collateral standard: electromagnetic compatibility – requirements and tests IEC 60601-2-40:2016 (Ed.

  • Page 19: Declaration Of Compliance For Iec 60601-1-2

    XLTEK Protektor32 Instructions for Use Declaration of Compliance for IEC 60601-1-2 Table 3 - Electromagnetic Emissions Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The Protektor32 is intended for use in the electromagnetic environment specified below. The customer or the user of the Protektor32 should assure that it is used in such an environment.
  • Page 20 Instructions for Use XLTEK Protektor32 Electrical Fast Transients / IEC 61000-4-4 ± 2 kV Bursts 100 kHz repetition frequency Surges IEC 61000-4-5 ± 0,5 kV, ± 1 kV Line-to-line (Differential Mode) Surges IEC 61000-4-5 ± 0,5 kV, ± 1 kV, ± 2 kV...
  • Page 21 XLTEK Protektor32 Instructions for Use Basic EMC Immunity Test Levels – Professional Phenomenon Standard Healthcare Facility Environment 100 kHz repetition frequency 0,15 MHz – 80 MHz Conducted Disturbances Induced IEC 61000-4-6 6 V in ISM bands between by RF Fields...

  • Page 22: Declaration Of Compliance For Fcc

    Instructions for Use XLTEK Protektor32 5,240 5,100 – WLAN 802.11 a/n Pulse 5,800 modulation 5,500 217 Hz 5,785 Declaration of Compliance for FCC Note: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules.

  • Page 23: Regulatory Symbols

    XLTEK Protektor32 Instructions for Use Regulatory Symbols A number of symbols appear on the various components of the Protektor32 system. Please consult the table below for their meanings and significance. Symbol Description ATTENTION: Consult Accompanying Documents Consult Accompanying Documents Consult Operating Instructions...
  • Page 24 Instructions for Use XLTEK Protektor32 Symbol Description Power On Power Off CE Mark Canadian Standards Association (indicates safety approval by) TUV Safety Tested and Production Monitored Made in Canada EU only: Do Not Dispose as Unsorted Municipal Waste...

  • Page 25: Protektor32 System Configuration

    XLTEK Protektor32 Instructions for Use Protektor32 System Configuration Device styles/models may vary from those shown above. Legend Description Legend Description Stimulator Pods Medical Grade Power Supply Low Current Stimulator Pods Isolation Box TCeMEP Pod PC/Laptop Acquisition Pods External Triggers Oximeter...

  • Page 26: Protektor Headbox

    Instructions for Use XLTEK Protektor32 Note: Use only Xltek approved cables and accessories with this device. Protektor Headbox The Protektor32 headbox contains a complete data acquisition system that has built-in amplifiers, A/D Converters, Digital Signal Processors, CPUs, and storage devices.
  • Page 27 XLTEK Protektor32 Instructions for Use Connecting Protektor Headbox The instructions which follow demonstrate how to connect the Protektor32 headbox to a laptop or desktop computer. Position the equipment so that the detachable mains cord is readily accessible for disconnection. 1. Plug the power cord into the Isolation Box.
  • Page 28 Instructions for Use XLTEK Protektor32 Figure 3: Connecting the Acquisition box to the Stimulator box 4. Connect the USB cable between the Isolation box and the Laptop / Desktop PC. Figure 4: Connecting the Isolation box to the Laptop 5. Connect the Acquisition / Stimulator pods to the acquisition and stimulator boxes.
  • Page 29 XLTEK Protektor32 Instructions for Use...

  • Page 30: Using The Tcmep Stimulator With Protektor32

    Instructions for Use XLTEK Protektor32 Using the TcMEP Stimulator with Protektor32 The TcMEP stimulator with Protektor 32 provides a mode of operation that delivers single or train stimuli at a rate up to a few pulses per second. Safety Information...

  • Page 31: Tcmep Warnings And Cautions

    XLTEK Protektor32 Instructions for Use TcMEP Warnings and Cautions Stimulating electrodes must be large enough so that the current density is always less than 2 mA r.m.s./cm . Current densities exceeding 2 mA r.m.s./cm may require special attention of the operator. For example, if the stimulus is stimulating at 100 mA at 10 Hz, with a duration of 1 ms, then the stimulus electrode must be at least 0.5 cm...

  • Page 32: Stimulation Limitations Of The Tcmep Modality

    Instructions for Use XLTEK Protektor32 When both a high-frequency surgical instrument and the electric stimulator are used for the patient at the same time, there is a possibility that burns will result where the electrode is applied or damage to the electrode used. Remove the electrode when you use a high- frequency surgical instrument.

  • Page 33: Current Density

    DISPOSABLE SILVER EEG DISC ELECTRODES - Diameter of cup: 10 mm; Height of cup: 3 mm; Surface area = 90 mm (Part #105191 in the Natus Neurodiagnostic Accessories Catalogue) If you use settings-setups combinations exciding those detailed in Table 4 above, stimulation may result in skin burns and will require special attention of the operator.
  • Page 34 Instructions for Use XLTEK Protektor32 Train of pulses Next Train of pulses total num total num pulses pulses Min Repetition Time (1 second)

  • Page 35: Recommended User Performed Maintenance

    XLTEK Protektor32 Instructions for Use Recommended User Performed Maintenance Routine System Maintenance In a solid state system, with no moving parts, there is no need for routine maintenance. However, if you still wish to test the system, input a 1 mV, 1 Hz square wave using a calibrated signal generator. The waveform displayed on screen should appear as a square wave with appropriate amplitude and frequency.

  • Page 36: Environmental Conditions

    Instructions for Use XLTEK Protektor32 Environmental Conditions Operating Environmental Temperature: 10° to 40°C Limits Relative Humidity: 30%–75% Altitude: Up to 4600 meters above sea level Atmospheric Pressure: 500 hPa to 1060 hPa Transport and Storage Limits Temperature Range: -40°C to 70°C Humidity Range: 10%–100%, including condensation...

  • Page 37: Protektor32 Software / Epworks

    XLTEK Protektor32 Instructions for Use Protektor32 Software / EPWorks Setting Up Tests A) Before You Begin 1. Ensure that the headbox is connected to the computer and turned on. 2. Open EPWorks by double-clicking the EPWorks icon on the Windows® desktop.
  • Page 38 Instructions for Use XLTEK Protektor32 B) Edit Text Window Tabs – Configuring a Basic Test The following tests can be configured from the Edit Test window tabs: Electrodes • Groups • EEG Montage Traces • • Channels (Amplifier Inputs) Markers •...
  • Page 39 XLTEK Protektor32 Instructions for Use C) Electrodes Tab To make any required modifications to the electrode locations: 1. Click the Electrodes tab; 2. Enter your changes (e.g., add muscles or special electrodes) 3. Click Save.
  • Page 40 Instructions for Use XLTEK Protektor32 D) EEG Tab The EEG tab allows you to set up channels and filters for an EEG montage. Standard 10-20 locations defined in the Electrodes settings are automatically placed on the EEG tab head map.
  • Page 41 XLTEK Protektor32 Instructions for Use 7. Click OK to save. To use the head map to set up Referential Channels: 1. Click a location on the headmap to select Input 1. A new channel will appear in the EEG table with Input 1 set accordingly.
  • Page 42 Instructions for Use XLTEK Protektor32 E) Channels Tab To specify the electrodes you will be using in each channel: 1. Click the Channels tab. --Each pair of electrodes that is added here will use one of the available channels on the headbox. -- Click Append to add a new channel to the Inputs table.
  • Page 43 XLTEK Protektor32 Instructions for Use 7. To set the auto squelch or speaker so as not to respond below a certain level, and avoid 60 Hz hum, right-click the cells in the Squelch column and set a squelch threshold. 8. Click Save.
  • Page 44 Instructions for Use XLTEK Protektor32 G) AV/Ext Stimulators Tab The AV/Ext Stimulators tab is used to set stimulation parameters for the internal Auditory/Visual stimulators and /or the external Trigger In/Out ports. 1. Use the Stimulator pull-down menu to select the type of stimulator hardware that will be used for the test.
  • Page 45 XLTEK Protektor32 Instructions for Use 3. Select a Contralateral Sound. This setting allows you to select which type of stimulation to use in the ear that is opposite to the ear that is being monitored. • Masking Tone: A contralateral sound used for auditory stimulation raises the threshold of audibility for the ipsilateral sound by the presence of another (masking) sound.
  • Page 46 Instructions for Use XLTEK Protektor32 To set up one or more timelines: 1. Click the Timelines tab. 2. To add a new timeline row to the timelines table, click Append. 3. To select the type of timeline, right-click the cell in the Type column and select Interleaved or Consecutive.
  • Page 47 XLTEK Protektor32 Instructions for Use To set up groups for the test: 1. Click Append, to add a row for a new group. 2. Enter a name for the group in the Name column. 3. To select a signal type for the group, right-click the cell in the Signal Type column and select Free Run, Triggered or Averaged.
  • Page 48 Instructions for Use XLTEK Protektor32 10. The Trig. Delay column (for triggered stimulation) sets the delay in milliseconds from the time the simulation starts to the start of the acquisition. You can set the trigger delay to both positive and negative values.
  • Page 49 XLTEK Protektor32 Instructions for Use To set up traces to appear in the groups: 1. Click Append and then select a group from the menu of groups to add a trace to the test. A new row is added to the Traces table.
  • Page 50 Instructions for Use XLTEK Protektor32 To Set Up the Marker Definitions Table: 1. Click the Append button to add a row to the marker definitions table. 2. Right-click the cell in the Style column and select from: • Amplitude Cursor •...
  • Page 51 XLTEK Protektor32 Instructions for Use Note that you can set up as many markers as required for the test. To Set Up the Calculations Table: 1. Click the Append button to add a row to the marker calculations table. 2. You can enter a name for the calculated result in the Name column. If a name is not entered, EPWorks will automatically assign a name based on the markers selected in the From and To columns.

  • Page 52: Data Acquisition

    Instructions for Use XLTEK Protektor32 Data Acquisition Types of Recordings The following types of recordings can be performed with Protektor 32: • Somatosenory Evoked Potentials (SSEP) • Transcranial Motor Evoked Potentials (TcMEP) Visual Evoked Potentials (VEP) • Brainstem Auditory Evoked Potentials (BAEP) •...

  • Page 53: Acquisition Toolbar

    XLTEK Protektor32 Instructions for Use Acquisition Toolbar See the Toolbar Buttons chapter for the definition of the buttons. Stimulators Window The Stimulators Window allows you to set the duration, rate, and intensity of individual stimulators while the study is on-going.

  • Page 54: Waveform Window

    Instructions for Use XLTEK Protektor32 Waveform Window The waveform window shows the results of your test in traces and sets of waveforms that are assigned to groups. In recording mode, the title bar shows whether the data in the waveform window is Live (currently being acquired) or Historical (a snapshot of data that was acquired at an earlier point in the study).

  • Page 55: Waveform Display Mode - Menu Options

    XLTEK Protektor32 Instructions for Use Waveform Display Mode – Menu Options To view or change the display mode of a group in a waveform window, right-click a trace label and select Display Mode from the pop-up menu. The two main display mode categories are Traces Stack and Sets Stack. You can toggle between viewing the waveforms in Traces Stack or Sets Stack mode by clicking the first item on the Display Mode pop-up menu.
  • Page 56 Instructions for Use XLTEK Protektor32 Traces Display Mode Waveforms are displayed sequentially in time according to the display mode of the group. A maximum of 50 traces are displayed consecutively. –See below examples of traces Stack. Note that traces can also be displayed as Sets Stack.

  • Page 57: Using Markers

    XLTEK Protektor32 Instructions for Use Using Markers To place a marker on a waveform: 1. Select a Marker button. 2. Move the pointer to the desired position and click. The marker is placed on the waveform. Calculations for the marker appear in the marker calculation results section of the waveform window.

  • Page 58: Measuring Waveforms With Cursors

    Instructions for Use XLTEK Protektor32 To access the Marker Calculation options pop-up menu, right-click a cell in the marker calculations table. Show Absolute Marker Value • • Show Difference To Baseline • Show Percent Difference To Baseline Print Table of Values •...

  • Page 59: Impedance Check

    XLTEK Protektor32 Instructions for Use To run multiple Timelines at the same time: 1. Open the Stimulators Properties window, select Customize... from the Tools menu and click the Stimulators tab. 2. Select the Enable running multiple timelines and stims option and click OK.
  • Page 60 Instructions for Use XLTEK Protektor32...

  • Page 61: Eeg / Spectral Windows

    XLTEK Protektor32 Instructions for Use EEG / Spectral Windows EEG Live Window The EEG Live window displays EEG data according to the currently active montage settings. --Montages are set up in the Montage tab of the Edit Test window. You can edit the channel settings temporarily in the settings option menu in the EEG waveform window.

  • Page 62: Eeg Review Window Overview

    Instructions for Use XLTEK Protektor32 Time Mark: You can use the mouse to drag the time mark line to a particular point. • Time Stamp: The Time Stamp in the title bar automatically updates to reflect the current position of •...

  • Page 63: Spectral Window: Csa And Dsa Eeg

    XLTEK Protektor32 Instructions for Use Spectral Window: CSA and DSA EEG Raw EEG is processed using FFT (Fast Fourier Transform) technique and displaying the EEG spectrum. The EEG frequency spectra are displayed as Power (μV2) or Amplitude (μV) as a function of frequency.
  • Page 64 Instructions for Use XLTEK Protektor32 Density Spectral Analysis (DSA) Window 1. Montage Channel Label 2. Spectral Edge 3. Frequency Axis 4. Power Axis is shown in the display of color. 5. Time Axis...

  • Page 65: Quadrant-Dsa Window

    XLTEK Protektor32 Instructions for Use Quadrant-DSA Window The Quadrant Density Spectral Analysis Window displays density spectral analysis groups in quadrants. - -To see results in the Quadrant-DSA window, Quadrants must be set in the Edit Test -- Montage tab window. To open the Quadrant-DSA Properties, right-click the background of the Quadrant DSA Window and select Properties..

  • Page 66: Spectral Review Windows

    Instructions for Use XLTEK Protektor32 Spectral Review Windows All Spectral Windows –CSA, DSA, Q-DSA– can be viewed in Review mode. Use the Timebar to move back and forth in time as you Review your Spectral Window.

  • Page 67: Reviewing A Study

    XLTEK Protektor32 Instructions for Use Reviewing a Study To review a study: 1. Close all active windows by selecting Close Study from the File menu. 2. Select Review from the File menu. 3. Select a file to review from the Open dialog box.

  • Page 68: Timebar

    Instructions for Use XLTEK Protektor32 Timebar The Timebar displays an overview of the entire study allowing you to review it and access its information. Note that the Timebar feature is available in Recording and Review modes. Timebar Overview 1. Note Ticks 2.
  • Page 69 XLTEK Protektor32 Instructions for Use 7. Historical Test Section (Gray) 8. Current Test Section (Yellow) 9 Live Study Section (Aqua) 10. Next Set 11. In Recording mode, the slider jumps back to live study section. In Review mode, the slider jumps to the end of the study.

  • Page 70: Log Book

    Instructions for Use XLTEK Protektor32 Log Book The Log Book keeps a record of all notes that are added to the test, as well as the particular waveform, if any, that each note is associated with. Note that the Log Book feature is also available in Recording mode.

  • Page 71: Trending Window Overview

    XLTEK Protektor32 Instructions for Use Trending Window Overview The Trending window is used to display ordered sequences of calculations for the markers on each of your tests. 1. Trending Display Configuration button: 2. Sets number of minutes of data displayed in the Currently set to display All Calculations.

  • Page 72: History Window Overview

    Instructions for Use XLTEK Protektor32 13. Red triangle exceeds user’s defined levels. – 14. Go to Previous Note. i.e., “Out of Range Level”. History Window Overview The History window allows you to review all of the waveforms/traces that were acquired over the course of a study, including those that were deleted when the maximum number of sets for a waveform window was reached.
  • Page 73 XLTEK Protektor32 Instructions for Use Time Scale Size Status bar messages change according to the position of the mouse pointer. Toggle time scale units between minutes Move display to end of time scale. and seconds. Adjust All Gains Step start of time scale forward.

  • Page 74: Reports

    Instructions for Use XLTEK Protektor32 Reports Creating Generic Reports Each EPWorks Report is generated using two different types of Reporting Template: Study Template: includes information inserted from the Patient Study • −e.g., Patient Information and Case Summary. Test Template: includes collected data from your Patient Study •...

  • Page 75: Remote Monitoring

    XLTEK Protektor32 Instructions for Use Remote Monitoring Before You Begin Before you can begin using XLTEK Portals software (i.e. LocalPortal and RemotePortal), consult your hospital or institution's IT department to configure the appropriate IP addresses, subnet masks and default gateways.

  • Page 76: Multiple Connections

    Instructions for Use XLTEK Protektor32 Multiple Connections You can monitor more than one Acquisition Station by more than one Remote Station. The following configurations below are the available: Both Local Portal (LP) and Remote Portal (RP) can run on the same station at the same time.
  • Page 77 XLTEK Protektor32 Instructions for Use Video Microscope A video of the microscope feed can be obtained by connecting the Protektor32 Microscope Integration Kit. To open the microscope view click View tab and then Microscope. Once the video is displayed you will have the option to record video segments up to 10 minutes at a time.

  • Page 78: Toolbar Buttons

    Instructions for Use XLTEK Protektor32 Toolbar Buttons Toolbar Button Description Averager On/Off Free Run Acquisition On/Off Controls Triggered Acquisition On/Off Stop All Stimulators. Sets Delete Set and Restart Averager Keep Current Set. Latency Difference Cursor Amplitude Difference Cursor Cursors Absolute Latency Cursor...

  • Page 79: Accessories

    Pedicle Screw Probe EEG accessories which can be used with the Protektor32 amplifier are available for you to browse the Natus Neuro Catalog online at www.natus.com or call Natus Sales and Support at 1-800-303-0306. The following are compatible accessories: Part Number Description...
  • Page 80 Instructions for Use XLTEK Protektor32 The Protektor32 must be used only with legally marketed electrodes in the country where in use. For instance, in the United-States use only FDA approved, legally marketed electrodes. In Canada use only Health Canada approved legally-marketed electrodes;...
  • Page 81 A total service solution Standing behind every Xltek product is Natus Medical Incorporated, an internationally respected innovator of medical products and services. Our Neurology systems are backed up by an in-house support team staffed with technical and clinical experts, 24/7 support, remote support via WebEx or VPN, the largest clinical and technical field support network in Neuro/Sleep and customized service contracts that include preventative maintenance visits and computer upgrades.

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