Neuro Check
Contents
1. Fig 18 Nuvasive M5 Adapter Connections Bipolar Nuvasive NeuroVision M5 System Setup Monopolar Mode Renal Typically monopolar setup is used only when nerve is unresponsive to bipolar stimulation 6 1 The Nuvasive NeuroVision M5 system requires an adapter order code iO N Adapter in order for the NeuroCheck to communicate with the M5 system in monopolar mode LBL1210 Rev Q DCR 15 0004 Effective Date 2015 04 07 Page 15 17 Instructions for Use Almendia Neuro Check device with Wire M5 Adapter Pin e Fig 19 Nuvasive M5 Adapter Monopolar NeuroCheck Black Connector M5 NeuroCheck ua Stimulation Black a Pin Connector Clip Patient Module s Accessory Stimulation M5 Clip Adapter t Fig 20 Insert the needle Fig 21 Using the Nuvasive Fig 22 Plug the connector end of portion of the M5 Pin into the supplied M5 Stimulation Clip the M5 Stimulation Clip into the NeuroCheck s black clasp the M5 Pin s exposed accessory port of the Patient connector metal body Module Connect the Nuvasive electrode or needle to the Nuvasive anode lead Place Nuvasive electrode on patient per Nuvasive instructions or physician instructions Nuvasive electrode adhesive surface side P T C a tt i oF NY Fig 23 Nuvasive electrode pad connection Note The M5 adapter components may be reused after wipe down cleaning and low level disinfection using Isopropyl Alcohol min2. Z z Black i 4 Connector i M5 M5 NeuroCheck Stimulation Black Pin Connector Clip Patient i atien Module s A m ae Accessory vs N ao a yL Stimulation M5 Clip Adapter Pin Fig 14 Insert the needle portion Fig 15 Using the Nuvasive Fig 16 Plug the connector end of the of the M5 Pin into the supplied M5 Stimulation Clip M5 Stimulation Clip into the NeuroCheck s black connector clasp the M5 Pin s exposed accessory port of the Patient Module metal body Connect the M5 Adapter Cable to the NeuroCheck s red connector Connect the M5 adapter cable s horseshoe shaped connector to the Nuvasive anode lead Figure 17 F p y Af 5 M5 Adapter v NeuroCheck Red lt Connector M5 Adapter Cable Nuvasive anode lead Fig 17 M5 Adapter Cable Connection The M5 adapter components may be reused after wipe down cleaning and low level disinfection using Isopropyl Alcohol min 70 or equivalent Verify connections with Fig 18 for a bipolar configuration set up LBL1210 Rev Q DCR 15 0004 Effective Date 2015 04 07 Page 14 17 Instructions for Use Almendia Neuro Check device with Wire Patient Module s ies Accessory j a gt 5 lt F s i a a Nuvasive E d Anode lead Nea ae timulation NeuroCheck Fad Black Connector NeuroCheck M5 Red Cable Nuvasive M5 Adapter Connections Bioolar
3. Instructions for Use Almendia Neuro Check device with Wire DEVICE DESCRIPTION The Neuro Check device assists in the localization of nerve roots during spinal surgery where visualization is limited The Neuro Check is designed to route electrical stimulus signals from a standard Electromyography EMG System to two sets of electrodes on the device in order to make an assessment as to relative nerve root location It is comprised of a proximal handle a rigid shaft and a thin flexible distal platform featuring an array of electrodes on the top and bottom surfaces with embedded radiopaque markers See Figure 1 below Flexible Platform Rigid Shaft Switch Figure 1 Neuro Check device Electrodes Radiopaque Markers Figure 2 Flouroscopic Image of Flexible Electrode Platform HOW SUPPLIED The iO Flex Neuro Check device is supplied sterile for single patient use and is packaged with the iO Flex Wire to facilitate placement of the Neuro Check device and other iO Flex devices iO NCW iO Flex Neuro Check with Wire LBL1210 Rev Q DCR 15 0004 Effective Date 2015 04 07 Page 1 17 Instructions for Use Almendia Neuro Check device with Wire INTENDED INDICATION FOR USE The Neuro Check device can be used with an iO Flex cutting and biting device for localization of motor nerves in settings where visualization is compromised CONTRAINDICATIONS None known WARNINGS Do not proceed wi
4. 70 or equivalent Verify connections with Figure 24 for a monopolar configuration set up LBL1210 Rev Q DCR 15 0004 Effective Date 2015 04 07 Page 16 17 Instructions for Use Almendia Neuro Check device with Wire Patient Module s Accessory port as A e amp amp t l ce p 3 Nuvasive E a Anode lead NeuroCheck Black Connector ANdantar qapte Pin Nuvasive M5 Adapter Connections Monopolar Nuvasive electrode typically gt upper back Fig 24 Nuvasive Adapter Connections Monopolar Manufactured in the USA by Amendia Inc 1755 West Oak Pkwy Marietta GA 30062 877 755 3329 www amendia com LBL1210 Rev Q DCR 15 0004 Effective Date 2015 04 07 Page 17 17
5. Date 2015 04 07 Page 4 17 Instructions for Use Almendia Neuro Check device with Wire Advance the Neuro Check device into the foramen ensuring that the white surface of the handle and more importantly the corresponding electrodes of the Neuro Check device adjacent to the white handle face away from the patient see Figure 4 White Handle Surface Figure 4 Neuro Check device orientation during insertion Use fluoroscopic guidance to confirm correct placement and to confirm that Electrode Platform is not twisted See Figure 5 CAUTION Do not stimulate while advancing the Neuro Check device into position Figure 5 Fluoroscopic image of twisted Neuro Check device LBL1210 Rev Q DCR 15 0004 Effective Date 2015 04 07 Page 5 17 Instructions for Use Almendia Neuro Check device with Wire Set the EMG system to output the following recommended stimulus settings Neuro Check Stimulus Conditions Frequency Pulse Width Output Current Useable Ranges 3 13 5 00 Hz 150 500us 0 5 50mA max nee 4 13 Hz 0 5 50MA max Stimulus Settings Warning Set up EMG software to limit the maximum allowable stimulation current to 50mA during use of the Amendia Neuro Check Device to reduce the possibility of overstimulation Refer to the hospital supplied EMG intra operative Neuromonitoring user manual for specific set up and operation The NeuroCheck device is able to stimulate with electrodes facing in the direct
6. Situation Possible Causels Ventral iAlmendia Nerve root may Remove Neuro Check device and wire threshold gt Dorsal threshold No EMG response up to 50 mA for both dorsal and ventral have been inadvertently hooked Device unplugged Paralytics active Electrodes not in close enough Reinsert and reposition Probe more caudal and dorsal Repeat steps 4 18 Confirm similarity of output and return current Confirm full train of four response Apply below steps a e in Bipolar mode Apply below steps a e in Monopolar mode electrode sets proximity to nerve a Pull electrodes further out lateral Set stimulation to ventral black channel at a constant Nerve may be amperage SES pone Slowly draw electrodes back medial with constant bottom electrical current until response attained stimulation Reduce current back to OmA Recheck Dorsal and Ventral readings per steps 14 17 Redeploy probe more cephalad in foramen Nerve may be parallel to Electrode Platform Similar Dorsal and Ventral Thresholds Apply above steps a e in bipolar mode only Use previously attained ventral threshold value as constant ventral current set point Redeploy Probe more caudal in foramen 26 66cm LBL1210 Rev Q DCR 15 0004 Effective Date 2015 04 07 Page 8 17 Instructions for Use Almendia Neuro Check device with Wire SYMBOLS symbol i Use only with Typ
7. Set Up Failure to properly follow instructions may result in improper functioning of the device and may lead to patient injury The Neuro Check device is intended to be used in conjunction with a certified Nationally Recognized Testing Lab NRTL approved Electromyography EMG intra operative neuromonitoring system capable of outputting stimulus signals under the following conditions Neuro Check Stimulus Conditions Frequency _ Pulse Width Output Current Useable Ranges 3 13 5 00 Hz max 150 500us max 0 5 50mA max TEO 4 13 Hz 0 5 50MA max Stimulus Settings LBL1210 Rev Q DCR 15 0004 Effective Date 2015 04 07 Page 2 17 Instructions for Use Almendia Neuro Check device with Wire e The iO Flex Wire is manufactured from a nickel titanium alloy Persons allergic to nickel titanium alloy including the major elements of nickel and titanium may suffer an allergic reaction to this device e For use only with iO Flex System devices e Do not use with other than specified components from another manufacturer e Do not use the product after the Use By date e Do not use the product if packaging integrity appears compromised open or damaged in any way e Do not attempt use if any component of the system appears damaged bent crushed or is missing e For single patient use only Do not reuse or resterilize Reuse or attempted resterilization of the device may lead to device failure and sub
8. and Wire from the package Wee THEN access is to be provided through a fixed use a tube no more than 9cm in length with tube a minimum inner diameter ID of 16mm After access to the posterior spinal canal has been achieved and the iO Flex Probe has been properly positioned see Instructions for Use iO Flex Probe introduce the sharp distal end of the Wire into the proximal handle of the Probe 1 Advance the Wire through the iO Flex Probe and out the skin lateral to the initial incision Adjust the Probe as necessary to achieve desired iO Wire exit trajectory While depressing the release button on the Distal Handle advance the sharp end of the Wire through the funnel of the Distal Handle to desired location The Distal Handle can be repositioned at any time by again depressing the release button and moving the handle relative to the Wire See Instructions for Use Distal Handle Attach the Neuro Check device to the proximal end of the Wire Hold the Wire at a 90 degree angle to the tip of the Neuro Check device Insert the barrel feature of the Wire into the opening on the Neuro Check device and rotate it 90 degrees to lock it into place See Figure 3 iO Wire Barrel Step 1 Align Wire barrel with Step 2 Insert Wire barrel Step 3 Rotate Wire 90 up Neuro Check device tip into Neuro Check device tip wards and pull forward Figure 3 Engaging the iO Wire to the Neuro Check Tip LBL1210 Rev Q DCR 15 0004 Effective
9. andpiece Fig 10 Insert Neuro Check black with the Nuvasive JJB black tip clockwise to lock connector into rear of adapter Handpiece receptacle down adapter Nuvasive electrode adhesive surface side Fig 11 Nuvasive anode and electrode attachment monopolar Place Nuvasive electrode stimulus return on patient per Nuvasive instructions or physician instruction In Monopolar mode the NC red connector wire remains unconnected Overall Nuvasive JJB monopolar connections shown below LBL1210 Rev Q DCR 15 0004 Effective Date 2015 04 07 Page 12 17 Instructions for Use Almendia Neuro Check device with Wire Neuro Check device with Wire a Nuvasive electrode he Fig 12 Nuvasive JJB Adapter Connections Monopolar The JJB adapter may be reused after wipe down cleaning and low level disinfection using Isopropyl Alcohol min 70 or equivalent Nuvasive NeuroVision M5 System Setup Bipolar Mode 5 1 The Nuvasive NeuroVision M5 system requires two adapters order code iO N Adapter in order for the NeuroCheck to communicate with the M5 system in bipolar mode ea M5 Adapter 9 M gt Cable Adapter Pin Fig 13 Nuvasive M5 Adapters Bipolar LBL1210 Rev Q DCR 15 0004 Effective Date 2015 04 07 Page 13 17 Instructions for Use Almendia Neuro Check device with Wire Connect the M5 Adapter Pin to the NeuroCheck and M5 stimulation clip as shown in Figs 14 16 below NeuroCheck
10. e BF medical equipment isolated patient connection Plus positive polarity indicated with red Minus negative polarity indicated with black Lot Number YYYY MM DD Content of Packaging Model Number Sterile Method of Sterilization Using Irradiation Cli GUIDANCE AND MANUFACTURER S DECLARATIONS Guidance and manufacturer s declaration for electromagnetic emissions please refer to EMG Systems Operators Manual or Directions for Use LBL1210 Rev Q DCR 15 0004 Effective Date 2015 04 07 Page 9 17 Instructions for Use Almendia Neuro Check device with Wire TYPICAL EMG SYSTEM HARDWARE SETUPS 1 1 Insert the Neuro Check s Red and Black cable connectors into the corresponding Red Positive and Black Negative receptacles on the EMG intra operative neuromonitoring system stimulus output box gt p Neuro Check black Connector Neuro Check red 5 connector Cadwell System Setup Monopolar Mode The Stimulus Return electrode connector is plugged into the Red Positive receptacle of the EMG neuromonitoring system stimulus output box The Neuro Check red Connector is not connected fr NeuroCheck black Connector Fig 2 Cadwell Monopolar Setup 2 4 The stimulus return electrode is connected to the patient per the instructions for the Stimulus return electrode or physician instructions LBL1210 Rev Q DCR 15 0004 Effective Date 2015 04 07 Page 10 17 Instructions f
11. he stimulation of each surface is stopped once an EMG response is elicited by that surface The delivered current thresholds are dependent on the patient response It can be expected that the White surface current thresholds will differ from the Black surface current thresholds When safe device to nerve root location is achieved device found to be dorsal to the nerve root turn off stimulus signal disengage and remove the Neuro Check leaving the Wire in place CAUTION Do not proceed with iO Flex decompression devices unless the nerve to wire relative location is visualized or all steps are repeated and an acceptable EMG response indicating safe device location is achieved Disengage the Neuro Check device from the proximal end of the Wire as illustrated below See Figure 9 Step 1 Align Wire and Neuro Step 2 Rotate Wire 90 Step 3 Pull Wire away from Check device Rx tip straight downwards Rx tip and push wire into the Rx tip Figure 9 Disengaging the wire from the Neuro Check Tip The iO Wire is now in the desired position and ready to accept an iO Flex Microblade Shaver device Refer to the iO Flex MSB Instructions for Use to continue LBL1210 Rev Q DCR 15 0004 Effective Date 2015 04 07 Page 7 17 Instructions for Use Neuro Check device with Wire 21 At the completion of the procedure dispose of used product in accordance with all local regulations for disposable medical products Technical Help Guideline
12. ion of either White or Black handle shell orientation stimulation surface The slider switch on the handle determines the stimulation surface With the White field visible through the status window stimulation occurs at the electrodes corresponding to the White surface of the device see Figure 6 When the all Black field is visible stimulation is active on the corresponding Black surface of the device see Figure 8 When the circle is visible the device does not transmit current OFF state see Figure 7 Figure 6 Stimulation active Figure 7 OFF state Figure 8 Stimulation active White surface Black surface Note Status window exists on both White and Black surfaces of device White surface shown above After the Neuro Check device is positioned correctly begin by stimulating the White surface of the Neuro Check device Slide the switch until the White field is visible Starting at 0 mA gradually ramp up current until an EMG response is attained LBL1210 Rev Q DCR 15 0004 Effective Date 2015 04 07 Page 6 17 Instructions for Use Almendia Neuro Check device with Wire WARNING Set up EMG System to limit the maximum allowable stimulation current to 50mA during use of the Amendia Neuro Check Device to reduce the possibility of overstimulation Note the required threshold stimulation current to elicit the EMG response Reduce current to OMA Note During threshold stimulation current determination process t
13. or Use Almendia Neuro Check device with Wire Nuvasive NeuroVision JJB System Setup Bipolar Mode 3 1 The Nuvasive NeuroVision JJB system requires an adapter order code iO N Adapter in order for the NeuroCheck to connect with the JJB system om Fig 3 JJB Adapter Finally insert the NeuroCheck s red connector into JJB system box as shown in Fig 7 below NC black connector The JJB adapter may be reused after wipe down cleaning and low level disinfection using Isopropyl Alcohol min 70 or equivalent 3 2 Connect the JJB Adapter the Nuvasive JJB Handpiece and the Neuro Check as illustrated in Figures 4 6 below Fig 4 Mate the JJB adapter Fig 5 Then rotate Handpiece Fig 6 Insert Neuro Check black with the Nuvasive JJB black tip clockwise to lock connector into rear of adapter Handpiece receptacle down adapter 3 3 N Nuvasive NeuroVision JJB System Setup Monopolar Mode LBL1210 Rev Q DCR 15 0004 Effective Date 2015 04 07 Page 11 17 Instructions for Use Almendia Neuro Check device with Wire Biad Typically monopolar setup is used only when nerve is unresponsive to bipolar stimulation The Nuvasive NeuroVision JJB system requires an adapter Catalog iO N Adapter in order for the NeuroCheck to connect with the JJB system Connect the JJB Adapter the Nuvasive JJB Handpiece and the Neuro Check as illustrated in Figs 8 10 below Fig 8 Mate the JJB adapter Fig 9 Then rotate H
14. sequent patient injury Attempted resterilization of the device may create the risk of contamination and patient infection e Do not use with neuromuscular blocking agents as these may impair EMG collection resulting in false readings e Do not use excessive force when pulling in or positioning as the device or neural structures may become damaged e Donot immerse the device in liquid Immersing the device in liquid could cause the unit to fail CAUTION Always exercise caution handling the sharp distal tip of the iO Wire to prevent needle stick injuries CAUTION Federal U S A law restricts this device to sale by or on the order of a physician ADVERSE EVENTS The complication rate of the iO Flex Neuro Check or any iO Flex System Device in commercial use has been demonstrated to be low lt 5 device related The events listed below are associated with use of the iO Flex System in order of more to least likely e Transient nerve irritation e Hematoma e Bone fracture e Durotomy with or without CSF leakage e Neuropathy e Bleeding requiring transfusion e Infection e Paralysis e Bowel Bladder incontinence LBL1210 Rev Q DCR 15 0004 Effective Date 2015 04 07 Page 3 17 Instructions for Use Almendia Neuro Check device with Wire DIRECTIONS FOR USE Inspect all packages for damage Open using sterile technique and inspect for any signs of physical damage to the device and cable Remove the Neuro Check device
15. th iO Flex decompression devices unless all steps are repeated and an acceptable EMG response indicating safe location is achieved Patient movement may occur during stimulation and may lead to inadvertent neural injury Take adequate steps to avoid stimulation when patient movement could cause injury Portable and mobile RF communications equipment can affect function of the device Do not use Neuro Check in conjunction with high frequency monopolar or bipolar electrosurgical equipment and neurodiagnostic equipment Simultaneous use may result in burns at the site of the electrical stimulator and or amplifier electrodes and possible damage to the electrical stimulator The system is not designed to operate in an explosive environment or in the presence of flammable anesthetics The use of accessories transducers and cables other than those specified by Amendia may result in increased electro magnetic emissions or decreased electro magnetic immunity of the device Do not attempt to service unit No user serviceable parts are inside Decompressing L1 L2 with the iO Flex system is not advised due to the theoretical risk of damage to the conus medullaris and the low incidence of stenosis at this level PRECAUTIONS This device should only be used by personnel trained in the use of this device Use only as directed and described in this IFU Read all instructions prior to use including the Directions for Use for the NeuroCheck EMG Connection
Download Pdf Manuals
Related Search