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XLTEK Protektor32

Instructions for Use

TABLE OF CONTENTS

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 ................................................................................................................... 11

Protektor32 with the Electro-Surgical Units (ESU) – Guidelines .......................................................................... 12

Output Waveforms ........................................................................................................................................... 12

Electrostatic Discharge (ESD) handling procedures and warnings ....................................................................... 13

PROTEKTOR32 SAFETY AND STANDARDS CONFORMITY .................................................... 14

Essential Performance ....................................................................................................................................... 14

Standards Compliance and Normative References Information ......................................................................... 14

Declaration of Compliance for IEC 60601-1-2 ..................................................................................................... 17

Table 4 - Immunity Test Levels - Enclosure Port ...................................................................................................... 17

Table 5 – Immunity Test Levels – Input A.C. Power Port ......................................................................................... 17

Table 7 – Patient Coupling Port ............................................................................................................................... 18

Table 8 – Immunity Test Levels - Signal Input / Output Parts Port .......................................................................... 18

Table 9 - Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment ......... 19

Declaration of Compliance for FCC .................................................................................................................... 20

REGULATORY SYMBOLS .................................................................................................................... 21

PROTEKTOR32 SYSTEM CONFIGURATION ................................................................................. 23

Protektor Headbox............................................................................................................................................ 24

Protektor32 Headbox Features ............................................................................................................................... 24

USING THE TCMEP STIMULATOR WITH PROTEKTOR32 ...................................................... 28

Safety Information ............................................................................................................................................ 28

Contra-Indications and Exclusions ........................................................................................................................... 28

Protocol for Elicitation of TcMEPs ...................................................................................................................... 28

TcMEP Warnings and Cautions .......................................................................................................................... 29

Stimulation limitations of the TcMEP modality .................................................................................................. 30

Pulse Train Safety Limits .......................................................................................................................................... 30

Current Density ........................................................................................................................................................ 31

Содержание XLTEK Protektor32

Страница 1: ...XLTEK Protektor32 Instructions for Use...

Страница 2: ......

Страница 3: ...rights reserved This manual contains proprietary information which is protected by copyright and may not be copied in whole or in part except with the prior written permission of Natus Medical Incorpo...

Страница 4: ......

Страница 5: ...Declaration of Compliance for IEC 60601 1 2 17 Table 4 Immunity Test Levels Enclosure Port 17 Table 5 Immunity Test Levels Input A C Power Port 17 Table 7 Patient Coupling Port 18 Table 8 Immunity Tes...

Страница 6: ...ow Overview 50 Acquisition Toolbar 51 Stimulators Window 51 Groups Window 51 Waveform Window 52 Waveform Display Mode Menu Options 53 Using Markers 55 Measuring Waveforms with Cursors 56 Impedance Che...

Страница 7: ...ions for Use 5 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...

Страница 8: ...ercise professional judgment when using the information Protocols As stated by the America Academy of Neurology 2008 the quality extent and type of monitoring is exquisitely reliant on the rigors of t...

Страница 9: ...tems are fulfilled in the particular installation Non medical electrical equipment printers and computers complying with the appropriate IEC or ISO safety standards may be directly connected to the Pr...

Страница 10: ...ce the stimulation electrodes such that the stimulation current will be trans thoracic crossing the area of the chest and thorax The Protektor32 headbox carries ordinary classification for the level o...

Страница 11: ...device According to the IEC 60601 1 standard a BF device is an applied part isolated from other parts of the equipment to such a degree that no current greater than a set level flows if an unintended...

Страница 12: ...MPSO or extension cord shall not be connected to the system Do NOT connect items which are not specified as part of the system Do NOT touch any Protektor32 accessible metal parts and the patient simul...

Страница 13: ...non conductive inert surfactants or an Xltek approved cold sterilizing agent It is important to dry off the units quickly Avoid letting liquid seep into any of the internal electronics of the system D...

Страница 14: ...the ESU pencil away from the Acquisition box and stimulation electrodes 2 Use as large as possible patient ground electrode connected to the Protektor32 ground input 3 Do not place Protektor32 ground...

Страница 15: ...llow these techniques to help reduce the incidence of component damage caused by static electricity Immediately before handling any product components assemblies drain the electrostatic charge from yo...

Страница 16: ...ction against ingress of water IPX0 4 Degree of safety of application in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide Equipment not suitable for use in the...

Страница 17: ...2010 Ed 3 0 A1 2013 Medical electrical equipment Part 1 6 General requirements for basic safety and essential performance Collateral standard Usability IEC 62366 2007 Ed 1 0 A1 2014 Medical devices A...

Страница 18: ...Transient Burst Immunity Test IEC 61000 4 5 2005 Ed 2 0 Electromagnetic Compatibility EMC Part 4 5 Testing and Measurement Techniques Surge Immunity Test IEC 61000 4 6 2013 Ed 4 0 Electromagnetic Comp...

Страница 19: ...This equipment system is intended for use by healthcare professionals only This equipment system may cause radio interference or may disrupt the operation of nearby equipment It may be necessary to t...

Страница 20: ...e at 0 Voltage Interruptions IEC 61000 4 11 100 dip 250 cycles 50Hz 300 cycles 60 Hz Table 7 Patient Coupling Port Phenomenon Basic EMC Standard or Test Method Immunity Test Levels Professional Health...

Страница 21: ...requency MHz Band MHz Service Modulation Maximum Power W Distance m IMMUNITY TEST LEVEL V m 385 380 390 TETRA 400 Pulse modulation 18 Hz 1 8 0 3 27 450 430 470 GMRS 460 FRS 460 FM 5 kHz deviation 1 kH...

Страница 22: ...rference when the equipment is operated in a commercial environment This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructio...

Страница 23: ...2 system Please consult the table below for their meanings and significance Symbol Description ATTENTION Consult Accompanying Documents Consult Accompanying Documents Consult Operating Instructions Pr...

Страница 24: ...rotektor32 22 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...

Страница 25: ...ods P External Triggers E Oximeter Q Acquisition Head Box F Goggles R Stimulator Head Box G Cautery Detector H Headphones or Ear Inserts 1 Communication Cable I VGA Monitor 2 VGA Cable J Power Cable M...

Страница 26: ...ential 2 Independent Electrical Stimulators each with eight switchable output ports and 2 low current probe ports 1 Auditory Stimulator 1 Visual stimulator 2 Bi directional external triggers Full Band...

Страница 27: ...at the detachable mains cord is readily accessible for disconnection 1 Plug the power cord into the Isolation Box Figure 1 Power Connected to Headbox Power Connection 2 Connect the Isolation Acquisiti...

Страница 28: ...solation 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 Figure 5 Connecting a stimu...

Страница 29: ...XLTEK Protektor32 Instructions for Use 27...

Страница 30: ...cord The ultimate decision of how to use the TcMEP modes including stimulating electrode placement recording electrode placement and type of electrodes is up to the user We refer the user to published...

Страница 31: ...ulation with the TcMEP stimulator Cortical stimulation may not be appropriate for use on patients with a history of skull fracture or neurosurgical procedures to the head Skull defects could provide h...

Страница 32: ...1000 Ohm Load Safety requirement according to IEC60601 2 40 collateral standard 2 Energy limitation per time period Maximum 100mJ per second distributed in maximum 9 pulses on a 1000 Ohm load Pulse Tr...

Страница 33: ...current densities above 2mARMS cm2 Pulses per second 1 2 3 4 5 6 7 8 9 One EEG disc electrode 0 9cm2 Voltage Settings V 255 180 147 127 114 104 96 90 85 DISPOSABLE SILVER EEG DISC ELECTRODES Diameter...

Страница 34: ...Instructions for Use XLTEK Protektor32 32 1 2 total num pulses total num pulses 1 2 Min Repetition Time 1 second Train of pulses Next Train of pulses...

Страница 35: ...hnical Support at 1 800 303 0306 or contact your local Xltek representative Periodically check cable connections and electrodes for damage and wear Inspect cables for bent pins Replace frayed or worn...

Страница 36: ...ndensation Atmospheric Pressure Range 500 hPa to 1 060 hPa Electrical Ratings of Isolation Box Acquisition Box and Stimulator Box with Protektor32 Cart 24Vdc 2A Isolation Transformer Maximum Output Po...

Страница 37: ...tudy Information window so you can add or edit information The Settings button on the EPWorks toolbar opens the Edit Test window so you can input or change the test settings or switch to a new test Cr...

Страница 38: ...timulators Timelines Groups Traces Markers Layouts Reporting Test Directory New Test Test Directory New Test New Test Acoustic Nerve Bilateral SSEP Lower Interleaved Bilateral SSEP Upper Interleaved C...

Страница 39: ...ektor32 Instructions for Use 37 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 C...

Страница 40: ...t the remaining settings for the new channel right click column headings or individual cells and select values for LFF HFF Notch Color Gain and Quadrant from the pop up menus 4 Click OK to save To use...

Страница 41: ...the remaining settings for the new channels right click column headings or individual cells to select values for LFF HFF Notch Color Gain and Quadrant from the pop up menus See the topic EEG Channel S...

Страница 42: ...o so you must add another input channel 4 The amplifier gain is set in the Input Range column of the Inputs tab To set the same input range for all of the input channels right click the Input Range co...

Страница 43: ...N or Right PTN 4 To select a mode of stimulation right click the cells in the Mode column and select from single pulse repetitive pulse triggered free run and averaged Note that the selected mode dete...

Страница 44: ...ateral Sound that will be used for the test Click Pip or Tone Depending on which option you select you will need to refine your selection further These are your options Click Alternating Select to mak...

Страница 45: ...down menu allows you to select the visual pattern that will be used for the visual stimulation You can choose from Stripes or Quadrants a checker board pattern Color You can specify the color of the...

Страница 46: ...secutive Interleaving causes back and forth stimulation that alternates from one side to the other 4 In the Restart column set the restart property for each cell to Never Continuous or On Interval 5 C...

Страница 47: ...ght click the cells in the Sweeps Averages column to enter your preferred setting 8 To set a timeline for a group right click the cell in the Timeline column and select a timeline from the menu of tim...

Страница 48: ...ay Mode option 12 To set the number of traces displayed in Replace Mode or Overlay Mode For an individual waveform window right click the background of the waveform window and click the Layout tab For...

Страница 49: ...izes and virtually eliminates the interference from nearby electrical equipment Right click the cell in the Notch column to set the Notch filter to Off 60 Hz or 50 Hz 8 The sensitivity setting adjusts...

Страница 50: ...Then right click the cell in the Placement column and select from Manual Peak Trough When selecting Peak and Trough enter the appropriate values in the From ms and To ms columns Note that five millise...

Страница 51: ...in Step 3 then right click the To cell to select the first marker Note that It is not necessary to set a value in the To column if you select Latency calculation in the Type column in Step 3 5 Right...

Страница 52: ...tory Evoked Potentials BAEP Electromyography EMG Electroencephalography EEG Live Data Recording Window Overview 1 Live Data Recording View Window 2 Waveforms Toolbar 3 Title Bar 4 Toolbar 5 Stimulator...

Страница 53: ...Groups window allows you to start and stop the recording of data acquisition of data For each group in your test the Groups window reports the number of sweeps accepted NA column and the number of swe...

Страница 54: ...cal data in the waveform window 1 Title bar shows that this data is Live 2 Group menu is visible if more than one Group is assigned to the window The Group menu is hidden if only one Group is assigned...

Страница 55: ...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 1 Trace Label...

Страница 56: ...ay 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 Display Mode Illustration Description Ve...

Страница 57: ...the marker to a new location on the waveform Note that the calculation results are automatically updated as you move the marker To delete a Marker click the marker to select it and then press the Del...

Страница 58: ...ive waveform window Absolute Latency Measures the time in milliseconds of a particular point on the waveform in the active waveform window or history window Absolute Amplitude Measures the amplitude v...

Страница 59: ...n will restart For information on the Timebar Log Book and the History window features see the Reviewing a Study section Impedance Check The impedance check can be performed at any time during a study...

Страница 60: ...Instructions for Use XLTEK Protektor32 58...

Страница 61: ...l settings made with the wavewform setting option menu do not the settings for the test 1 Current Time location of the Sweep Edge 2 Montage Menu 3 Editable Montage Settings 4 Resizable Borders 5 Trace...

Страница 62: ...eview window is refreshed to display data from that point in the study Lock Button Click the Lock button to toggle the link between the Timebar and the EEG Review window on and off When the Lock butto...

Страница 63: ...e Spectral Window displays frequency characteristics of previously defined EEG traces in Compressed Spectral Analysis or Density Spectral Analysis formats The Spectra Settings of the CSA and DSA windo...

Страница 64: ...Instructions for Use XLTEK Protektor32 62 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...

Страница 65: ...roups 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 DS...

Страница 66: ...ctions for Use XLTEK Protektor32 64 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 W...

Страница 67: ...rowse for the patient file that you wish to review Then double click the file folder and select the patient s iom file e g John Smith iom 4 Once you have located the file you wish to review click Open...

Страница 68: ...ng 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 Impedance Check Tick 3 Transition between tests...

Страница 69: ...link use the option menu or the Timebar toolbar button The Timebar displays All tests that have been used in the course of a study including active currently live and inactive historical tests All of...

Страница 70: ...hat pertains to whole test 2 Note that is attached to the waveform 3 Time that the note was applied 4 For notes linked to waveforms shows the trace label set number and acquisition time 5 Drag the lin...

Страница 71: ...umber of minutes of data displayed in the graphs 3 Graphic is set to points display type 4 Graphic is set to vertical bars display type 5 Reading Gap is compacted and framed by dotted blue lines 6 Mov...

Страница 72: ...f sets for a waveform window was reached The waveform baseline will be shown with the most recently acquired waveform visible right above it Note that in Review the History window can be enabled allow...

Страница 73: ...the position of the mouse pointer 5 Toggle time scale units between minutes and seconds 13 Move display to end of time scale 6 Adjust All Gains 14 Step start of time scale forward 7 Float Notes 15 Ste...

Страница 74: ...rom the Patient Study e g Patient Information and Case Summary Test Template includes collected data from your Patient Study e g waveforms and calculation tables for each group After you have complete...

Страница 75: ...or Acquisition Station i e the computer that is acquiring the patient data This software enables data to be sent to one or more Remote Monitoring Stations i e to computers that are observing the Acqui...

Страница 76: ...rrently in the process of going across to the observer Remote monitoring Optimizations These are all optimizations that can reduce system load and network load both on the acquisition system and the r...

Страница 77: ...d you will have the option to record video segments up to 10 minutes at a time To record click on the red record button on the bottom left of the screen Both the start and stop time of the video clip...

Страница 78: ...lators Delete Set and Restart Averager Keep Current Set Cursors Latency Difference Cursor Amplitude Difference Cursor Absolute Latency Cursor Absolute Amplitude Cursor Customize Study Information Crea...

Страница 79: ...80 Protektor 32 Acquisition Box 003708 Probe Pod P32 Cr 005030 P32 Cautery Detector Cr 005031 Protektor 32 Visual Stim LED Goggles 010384 P32 Pulse Oxi LP Cable Cr 006640 P32 POWER SUPPLY 005562 P32 E...

Страница 80: ...n the United States use only FDA approved legally marketed electrodes In Canada use only Health Canada approved legally marketed electrodes in EU countries use only CE approved legally marketed electr...

Страница 81: ...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...

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