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MSD 1015 - Docket Alarm

1. 6 6 Box NIM Response Extended Service Agreement per system 2 Ea STIMULUS DISSECTION INSTRUMENTS 13 52400 13 53400 Kartush Stimutus Dissectian Instrument SEL eee nene I Set Includes 13 52401 1 Ea 13 52402 KSD Elevator wl Ea 13 52403 KSD Ring Disseciar 3mm Thin 13 52404 KSD Ring Dissector 2mm Thin 13 32415 KSD Cable Pratected Pin l Ea 13 52407 KSD Sterilization 6 13 52412 KSD Ring Disse
2. 2 Interpreting The Alarms 23 When The Case Is Complete s 25 When Monitoring 15 Complete 0 0 5 is m 23 3 Troubleshooting 6 9 24 4 Maintenance And Service 999 26 Preventive and Corrective Maintenance 2 22 22 262 6 2 6 6 26 MM 2 Appendix A Glossary amp Quick Reference Terms esee eene 28 Appendix Nerve Monitoring Accessories eese entem 32 Appendix C Approved Output Devices EN 35 Appendix D Technical
3. 3 Copyright 2000 Medtronic Xomed Surgical Products Inc AH Rights Reserved Made in U S A MEDTRONIC XOMEDSURGICAL PRODUCTS INC 6743 Southpoint Drive North Jacksonville FL 32216 Datalight is a registered trademark of Datalight Inc ROM DOS is a trademark of Datalight Inc Copyright 1989 1999 Datalight Inc All Rights Reserved This device complies with Medical Device Directive 93 42 EEC Authorized Representative for EC regulatory matters Medtronic Xomed Limited Unit 5 West Point Row Great Park Road Almondsbury Bristol B532 406 England TM are trademarks of Medtronic Xomed Surgical Products Inc w SAKUS xu Nue 01 4 CONTENTS SYMDOIS v TC ii Warnings And Precautions ii Customer Service pi 3 0 Warranty l Getting Started uos one oaase Med vue Copa r Eee Ve cere eril Device Description Na ee e RT UO Intended Use a eiecti metr UR rei a eng Indications P a Contraindications 2 335 Components 41 Operating Room Setup 2 Pront Pane 25 2 Rear Panel vers SONWare Seip Iu 2 2 2 4 6 Monitoring
4. 82 50105 NIM Response HP Printer Cable 82 40200 NIM Response Stand Storage Cart 82 50020 NIM Response Storage Carrying Case 4 82 50200 111111111 8 82 20300 NIM Probe kiss Hm 82 50600 NIM Response Patient Simulator 22 82 50610 NIM Response Biomed Test Package 82 50004 NIM Response Power Cord U S A 82 50003 NIM Response User s Guide m 30 28800 Stainless 5102 Stand with 2 shelves amp 2 drawers Ea 82 50150 NIM Response Repair Fa NIM 2 EMG ENDOTRACHEAL TUBES Two channels of surface electrodes with 8 cables Packaged with two green subdermal needles with 8 cables Packaged sterile Intended for single use only 2 29306 1 Protected Pin L Box 82 29307 Taim Protected Piisang aanhin ana J BON 82 29308 8mm 1 D Protected Pin roetine aiaiai iioii e oere BON MONOPOLAR AND BIPOLAR STIMULATING PROBES 82 25101 Protected Pin Nr 0 0 RT EN stb nas 0 Tip and Handle packaged sterile in individua
5. on which channel the event occurred A lower pitched beep represents j Channel 1 a higher pitched beep represents Channel 2 and so on through Channel 4 STIMULUS WARBLE TONES The STIMULUS WARBLE TONE sounds whenever electrical current is being delivered to the surgical field through the stimulus probe that is greater than 8096 of the set current The current delivered TONE or VOICE is not active below 05 mA The duration of the STIMULUS TONE is adjustable as follows OFF BRIEF CONTINUOUS OR VOICE Seve TONE VOLUME May be set by touching along the graphical volume contro bar with FULL volume to the far right Volume Control For Event Tones DEFAULTS Setting AM Default Other Options EMG Audio 000 4 0400 Off EMG Tones ass Off Stimulus o Btief s Continuous Voice Volume TET a A 0 10 1 00 Clock Submenu The CLOCK submenu allows the correct time and date to be entered into the NIM Response Time is displayed 12 hour and 24 hour formats The date format is U S mo day yr or CO day mo yr with leap year compensation valid up to 2100 Clock 19712199 Fermat Format 9 24 Hour E Clock Adjustment Window 15 Research Tools Submenu OUTPUT MENU Output The Output Menu is used to select whether information is
6. 73 3 3 3 3 3 3 5 13 52410 Crabtree Large 3 0mm 13 3241 Crabtree Small 2 5mm 34 et APPENDIX APPROVED OUTPUT DEVICES Device Manufacturer Address Phone Internet Device Manufacturer Phone Address Internet HP DeskJet 340 Printer Hewlett Packard Company 8000 Foothills Boulevard Roseville California 95747 658 916 786 8000 www hp com VGA S VIDEO converter AVerKey300 Gold AVerMedia Tel 510 770 9899 47923 A Warm Springs Blvd Fremont CA 94539 www avermedia con 35 36 APPENDIX D TECHNICAL SPECIFICATIONS PHYSIGAL DIMENSIONS Size Weight ENVIRONMENTAL Operating Temperature range Storage Temperature range Humidity Barometric Pressure AMPLIFIER Channels 4 Input Sensitivities Sensitivity Selection Bandpass Input Noise Inpui Impedance olfset Rejection Common Mode Rejection Channel Enable Disable Controls Event Threshold Control and Display Patient Isalation IMPEDANGE MEASUREMENT Control Measuring Signal Measurement Range Measurement Mode RTIFACT DETECTION AND REJECTION Reference Channel Stimulus Artifact Electrocautery Interference Electrode Lead ELECTROSURGICAL REJECTION Mute Detector TRAP Interrupt Method Sensitivity to External Noise DISPLAY TOUCH SCREEN Type Resolution Dedicated Function Event Touchpad Controls
7. SYSTEM PERFORMANCE TURN OFF POWER TO THE NIM RESPONSE OR NIM Response PRINTER BEFORE CLEANING TO i PREVENT CLEANING SOLUTIONS FROM SEEPING INTO THE ELECTRONIC PORTIONS OF THE INSTRUMENT SPRAY CLEANER LIGHTLY ON A COTTON CLOTH THEN WIPE THE INSTRUMENT WITH THE CLOTH BE ESPECIALLY CAREFUL AROUND THE CONTROLS CONNECTORS AND PANEL EDGES DO NOT USE ABRASIVE CLEANERS ATTEMPTED REPAIR OR EVIDENCE OF ATTEMPTED REPAIR BY ANYONE OTHER THAN QUALIFIED MEDTRONIC XOMED SERVICE PERSONNEL WILL VOID THE EQUIPMENT WARRANTY WARNINGS AND PRECAUTIONS CONTINUED iv IMPORTANT IT IS IMPORTANT TO DISTINGUISH BETWEEN THE PULSED SOUND EVENT TONES WHICH INDICATE EMG ACTIVITY THAT IS OVER THRESHOLD AND THE WARBLE SOUND CURRENT DELIVERED TONE WHICH INDICATES THE SET GURRENT IS BEING DELIVERED WHENEVER THE ALARM FOR PROLONGED MUTING OCCURS THE CAUSE MUST BE IDENTIFIED AND ELIMINATED IMMEDIATELY IF THE CAUSE IS NOT ELIMINATED IT MAY B IMPOSSIBLE TO PERFORM VALID MONITORING FOR THE REMAINDER OF THE PROCEDURE ALWAYS ATTACH THE MUTING PROBE AROUND THE ELECTROCAUTERY GORD FALSE LEAD OFF ATTENTION ALERT MAY RESULT FROM NON MUTED OVERLOADED EMG SIGNALS ENTERING THE NIM RESPONSE IF No CURRENT DELIVERED TONE SOUNDS AND THE MEASURED STIMULUS CURRENT FLOW IS LESS THAN 8096 oF THE SET AMOUNT EITHER NO CURRENT OR NOT ENOUGH CURRENT IS BEING DELIV ERED TO THE NERVE FACTORS WHICH MAY CONTRIBUTE TO THIS INCLUDE HIGH IMPEDAN
8. Vertical Display Event Capture Time Scale 36 7 em Wx 14 7cm H x 24 9 em D 12 5 3 32 C Operating 40 to 50 C 15 90 non condensing 700 1060 hPa Individually and simultaneously selectable 5000 pV peak to peak AC caupled Automatically zeroed 100 Hz 2 kHz EMG Display 192 Hz 3 2 kHz Audio EMG Speaker lt 3 mV RMS DC 4 KHz inputs shorted gt 250 MOhm 0 770 V DC Rejection gt 85 dB 60 Hz balanced inputs 265 dB 2 60 Hz I imbalance Dedicated function touchpads for independent channe enable disable Adjustable Graduated Touch Bar with V threshold setting displayed 1000 V RMS 60 Hz 500 HA Electrodes 10 Chassis Ground Dedicated ELECTRODE CHECK touchpad for measuring impedance 20 pA peak ta peak 30 Hz Square wave 0 250 with 0 1 resolution Calculated separately for each electrode including the ground electrade Automatic Artilact Detection by reference Channel placed in neutral tissue Synchronized muting adjustable by software switches Improved automatic detection and mitting with less interference Automatic detection miting and warming JHentilv retry Failed instructions More electrical shielding High contrast digital graphic electroluminescent visible in complete darkness 3 Display 64019 x 480W pixels Touch Panel 2561 x 256W Vertical Display Time Display and Capture 200 500 and 2000 pV display modes Enable disa
9. depolarization repolarization of a nerve The initiation and reaction of the firing of a nerve The positive and negative ions of the nerve switch polarity and retum to their original polarity sending a neural impulse down the nerve to its endpoint muscle distal Further from the center relative to a given fixed point as opposed to proximal e g the facial nerve at the level of the parotid gland is distal to the portion of the nerve in the mastoid process electrode impedance The electrical resistance value assigned to the capacity of the electrode to transmit current over its surface area electromyography Measurement of the electrical activity generated by the contraction and relaxation of a muscle elecironeuronography Measurement of the capacity nerve to transmit an electrical signal from one point to another elicited response A response to any form of stimulation versus a spontaneous response which seems to come from no known stimuli even In NIM Response terminotogy any EMG or artifact which is of an ampiitude over the EVENT THRESHOLD setting on the NIM Response This event will cause a Tone audio response if the Tone audio is activated evoked response See elicited response 29 APPENDIX A GLOSSARY amp QUICK REFERENCE TERMS CONTINUED frequency Number of repetitions in a given time period impedance Electrical property applied to the opposition a circuit offers to the flow of c
10. 004 19582900 0001 STK 10 0000 03 03 00 05 01 00 Due Date 05 10 00 Details lt 005 19605400 0001 STK 10 0000 03 08 00 05 17 00 Due Date 05 26 00 Details lt 006 19727300 0001 STK 3 0000 03 31 00 05 17 00 Due Date 05 26 00 Details lt 007 19727400 0001 STK 3 0000 03 31 00 06 19 00 Due Date 06 28 00 Details lt 008 19727500 0001 STK 3 0000 03 31 00 05 17 00 Due Date 05 26 00 Details lt 009 19754100 0001 STK 3 0000 04 04 00 11 17 00 Due Date 11 28 00 Details lt 010 19943300 0001 STK 1 0000 05 11 00 09 24 00 Due Date 09 28 00 Details 011 19943400 0001 STK 1 0000 05 11 00 09 24 00 Due Date 09 28 00 Details 012 20020200 0001 STK 3 0000 05 25 00 06 23 00 Due Date 07 02 00 Details 013 20020300 0001 STK 3 0000 05 25 00 06 19 00 Due Date 06 28 00 Details 014 20043400 0001 STK 2 0000 05 31 00 06 23 00 Due Date 07 02 00 Details 015 20043500 0001 STK 2 0000 05 31 00 06 23 00 Due Date 07 02 00 Details 016 20043600 0001 STK 13 0000 05 31 00 09 14 00 Due Date 09 18 00 Details i 017 20043700 0001 STK 2 0000 05 31 00 06 09 00 Due Date 06 18 00 Details lt 018 20043800 0001 STK 2 0000 05 31 00 06 09 00 Due Date 06 18 00 Details 019 20162600 0001 STK 9 0000 06 26 00 11 17 00 Due Date 11 28 00 Details 020 20268400 0001 STK 10 0000 07 14 00 10 01 00 Due Date 10 05 00 Details 021 20302700 0001 STK 10 0000 07 20 00 08 09 00 Due Date 08 18 00 Details 09 14 00 09 14 00 Seq Work Order Line T
11. 68E3247 B 03 00 P T C 5 foo REF 82 50003 y ATTACHMENT C SALES ORDER 1319647 1317631 1322022 1314475 LINE ITEM LOT SERIAL AR DOC 0002 8250001 19727500 000056 0002 8250001 19727500 000055 0002 8250001 19727500 000055 0002 8250001 19727500 000054 1337023 1337243 1337313 1337374 SO SHIP DATE CUSTOMER 05 26 2000 00 00 00 0557018 05 26 2000 00 00 00 2957271 05 26 2000 00 00 00 4101080 05 26 2000 00 00 00 4801230 CUS PO 9134007 ERIC DAVE EWER 521898001 NAME BOCA RATON COMM HOSPITAL GOSSE ERICK KAISER FOUNDATION HOSPITAL MANATEE MEMORIAL HOSP ADDR1 ADDR2 800 MEADOWS RD DO NOT MAIL A P DEPT CAPITAL PROCESSING PO BOX 12929 206 2NDST E ADDRS3 CITY STATE ZIP COUNTRY BOCA RATON FL XXX XX OAKLAND CA BRADENTON FL 33486 USA USA 946042929 USA 342080000 USA ATTACHMENT D MEDTRONIC INC WORK ORDER HISTORY FOR 8250001 NIM RESPONSE MAINFRAME 115V 1 EA Order Qty Open Date Start Date 022 20360200 0001 STK Due Date 09 18 00 023 20360500 0001 STK Due Date 09 18 00 Page 1 of 2 10 0000 07 31 00 Details 10 0000 07 31 00 Details lt Seq Work Order Line Type 001 19435700 0001 STK 10 0000 02 02 00 03 19 00 Due Date 03 28 00 Details 002 19481400 0001 STK 10 0000 02 09 00 03 24 00 Due Date 04 02 00 Details 003 19504600 0001 STK 10 0000 02 15 00 03 24 00 Due Date 04 02 00 Details
12. ncgative to positivc direction constant current stimulation i Electrical stimulation which is controlled by the amount of current desired at the site of stimulation independent of the electrode stimulator impedance characteristics constant voltage stimulation Electrical stimulation controlled by setting the voltage which delivers unknown levels of current dependent upon electrode stimulator impedance characteristics current 4 The movement of electrons through a conductor It is measured in milli amperes by the NIM Response APPENDIX A GLOSSARY 8 AUICK REFERENCE TERMS CONTINUED current jumping When stimulating current travels across tissue being stimulated to adjacent tissue not being directly stimulated Can be the cause of false positive responses current shunting When stimulating current shunts or escapes away from the targeted nerve to fluid CST blood c or irrigant in the surgical stimulating field Can be the cause of false negative responses CUSA Cavitron ic Ultrasonic Aspirator DC offset Excessive charge on the patient resulting from electrosurgical activity without proper patient grounding The presence of DC offset interferes with monitoring since the voltage levels of DC offset are generally greater than the EMG readings DC offset can be recognized by its characteris tic slope upward or downward default setting The automatic setting determined at the factory or achieved at Power Up
13. IS IN LIEU OF ALL OTHER WARRANTIES EXPRESSED OR IMPLIED WHETHER STATUTORY OR OTHERWISE INCLUDING ANY IMPLIED WARRANTY OR FITNESS FORA PARTICULAR PURPOSE In noevent shall MEDTRONIC XOMED be liable for any incidental defect failure or malfunction of the product whether a claim for such damage is based upon the warranty contract negligence or otherwise CUSTOMER RESPONSIBILITY A CAUTION This product and its components will perform reliably only when operated and maintained in accordance with the instructions contained in this manual accompanying labels and or inserts A defective product should not be used Parts which may be broken or miss ng or are plainly worn distorted or contaminated should be replaced immediately with clean genuine replacement parts manufactured by or available from MEDTRONIC XOMED The responsibility of MEDTRONIC XOMED for a defective product is limited by the warranty set forth in this manual Should repair or replacement of this product become necessary after the warranty period the customer should seek advice from MEDTRONIC XOMED prior to such repair or replacement Ifthis product is in need of repair it shoutd not be used unti all repairs have been made and the unit is functioning properly and ready for use The owner of this product has sole responsibility for any malfunction resulting from improper use or maintenance or by repair by anyone other than MEDTRONIC XOMED and from any malfunction caused by parts t
14. Response System Stimulator Fuse THE PATIENT INTERFACE BOX Patient Interface Box and Cable The PATIENT INTERFACE BOX and CABLE link the patient to the NIM Response ELECTRODE INPUTS Two electrodes per monitoring channel and one ground electrode are required The positive and negative electrodes for each channel plug into color coded input jacks on the PATIENT INTER FACE BOX Channel I is blue channel 2 red channel 3 violet channel 4 orange Plug patient Ground into the green input jack and the anode for the probe into the red input jack of the stimulator STIMULATOR OUTPUT The NIM Response System supports the use of two stimulation probes Each stimulator requires two leads one from the probe and one from tbe patient to provide a complete circuit The lead from the stimulator is the cathode and is plugged into the black negative jack The lead from the patient is the anode and is plugged into the red positive jack Plug the connections for the stimulator probe into the STIMULATOR OUTPUT jacks on the PATIENT INTERFACE BOX WARNING Do NOT TURN POWER TO THE NIM Response System ON WHEN THE STIMULATOR IS IN THE FIELD UPON APPLICATION OF POWER A PULSE OF 5 MAY BE DELIVERED FOR LESS THAN 0 01 S THIS MAY BE EXCESSIVE FOR SOME MONITORING APPLICATIONS STIMULATOR FUSE Replace with Type F 32 mA 250V fuse only THE MUTING PROBE A MUTING PROBE is connected around the output cable of equi
15. Specifications ON CT 36 Appendix E Agency Approvals Appendix F References X REF dL E SYMBOLS ATTENTION SEE INSTRUCTIONS FOR USE CATALOG NUMBER SERIAL NUMBER DATE OF MANUFACTURE USE BY DATE DO NOT REUSE STERILIZED BY ETHYLENE OXIDE DO NOT USE IF PACKAGE IS OPENED OR DAMAGED LOT NUMBER MARK OFF ON OFF ON VOLUME RELATIVE SCALE INDICATOR EXIT POP UP WINDOW HELP TYPE BF APPLIED PART PATIENT CABLE FUSE INPUT OUTPUT FOOTSWITCH CONNECTION A WARNINGS AND PRECAUTIONS It is important that the NIM Response operator be familiar with this manual its precautions procedures and safety issues Three labels are used in this manual to identify important concerns conditions or procedures A WARNING Identifies conditions or practices that present a risk of injury to the patient and or user CAUTION PRECAUTIONS Identifies conditions or practices that could result in damage to the equipment A IMPORTANT Identifies conditions or practices which require attention for most desirable monitoring results WARNINGS e THE USE OF PARALYZING ANESTHETIC AGENTS WILL SIGNIFICANTLY REDUCE IF NOT COMPLETELY ELIMINATE EMG RESPONSES TO DIRECT OR PASSIVE NEURAL STIMULATION AUDITORY AND VISUAL MONITORING ARE DISABLED WHILE MUTING 15 IN EFFECT THIS SYSTEM IS NOT EXPLOSION RESISTANT THEREFORE IT IS NOT TO BE USED IN THE
16. and eliminate possible source stimulation Cold inigation Laser heat Retraction on nerve or muscles being recorded Patient waking from nnesthesia Nerve drying Ultrasonic aspirator Check and correct all settings volume event threshald and eliminate sauree of inadvertent manipulation Determine response type from waveform pattem on 50 mS screen Disentangle recording electrode and stimulatorcables from drapes etc Check for intermittent stimulation from anesthesiolagist i e hand held electrical stimulator Move NIM Response system away ftom source of Check area near recording electrodes for excessive stretching interference Make sure Patient Interface cable and electrode wires da not cross other electrical equipment or cables 25 4 MAINTENANCE AND SERVICE This section of the User s Guide describes how to care for your NIM Response and what to do when you have problems Preventive maintenance does not require access to the interior of the instrument and may be performed by the technician operator For the safe and warranted use of the unit corrective maintenance and internal adjustments should be left to qualified MEDTRONIC service personnel PREVENTIVE AND CORRECTIVE MAINTENANCE 26 Preventive maintenance for the NIM Response System consists of visual inspection periodic cleaning and running a general checkout using the PATIENT SIMULATOR Follow t
17. contact your local MEDTRONIC XOMED representative Ifa problem is found with the microprocessor the NIM Response immediately returns to the second start up screen and indicate a microprocessor failure No more monitoring can take place ELECTRODE IMPEDANCE CHECKING Ensure that all electrodes are adequately connected to the patient and to the NIM Response before surgical drapes are in place The NIM Response has an impedance meter to perform this test Display the ELECTRODES screen to access the impedance rest The impedance for each individual electrode is shown with the resulting difference between the positive and negative electrodes for each channel The greater the difference belween the positive and negative electrodes on any one channel the greater the possibility that there may be unwanted background noise present on that channel 19 Typical impedance values are as follows Prass Paired EMG Electrodes 25 or less Subdermal needle electrodes 10 or less Hookwire electrodes 40 kQ or less Endotracheal 10 kQ or less Paired subdermal sees 20 k or less The difference in impedance between the positive and negative channel should be less than 10 20 of the lowest channel impedance Press the x in the upper right hand corner to return to the monitoring screen QUICK SETUP Al power up QUICK SE
18. documented to a HPGL compatible printer LS120 SuperDisk drive or a ZIP drive The Event Capture information is formatted according to Output Menu selections are sent to the Printer Data Output on the back panel of the NIM RESPONSE EVENT CAPTURE 2 Largest When the EVENT CAPTURE button on the Main Menu is ON it holds each Event on the screen until it is replaced by the next Event When EVENT CAPTURE is OFF the current EMG activity waveform is displayed reeze LARGEST A Li LARGEST displays each EVENT as it occurs and at the end series events displays the LARGEST of these waveforms The screen continues Channel Mute to display each EVENT and holds the LARGEST at the end of the series of Events FREEZE When Freeze button on the Main Menu is turned ON it will hold the i waveform until Freeze is turned OFF When Freeze is OFF the current EMG activity waveform is displayed CHANNEL MUTE When channel mute is selected a speaker icon appears with each selected channel Pressing the channel select button cycles through channel on channel mute speaker icon blank and channel off 16 OUTPUT mE am DEVICE Save Image Q When Printer is selected the Print button is displayed on the main menu File pex The default device is Printer o File Gln s When either the LS120 or the ZIP is selected the Print button becomes SAVE IMAGE or SAVE DATA depending on the
19. might generate an audible signal Another example would be any external nerve locator stimulator not synchronized with the NIM Response Another possible source of electrical signal is electrical leakage from faulty thermal cautery units You can identify the spurious signals by their lack of surgical context That is to say there was nothing the surgeon was doing at that moment that could have caused a true EMG response Another artifact signal that can be erroneously interpreted by the NIM Response as an EMG event can occur when the surgeon strikes two metal instruments together within the surgical field such as striking a metal suction tube with a dissecting tool Such signals are typically monophasic with fast onset and offset That is the signals appear on the screen as sharply peaked responses in one direction only E While these artifacts arc significantly different in waveform appearance from true EMG events which have a biphasic waveform the magnitudes of these signals can reach several hundred i microvolts exceeding the EVENT THRESHOLD Therefore his can cause the EVENT TONE to d sound This type of artifact cannot be automatically detected and ignored by the NIM Response i However the surgeon is usually aware when two instruments have been struck together and can therefore relate such false positive responses to the surgical context INTERPRETING THE ALARMS The alarms draw attention to any condition which prevents p
20. of CUSA may indicate nerve irritation Another example of when prolonged muting might occur is when a radio frequency signal of unknown origin occurs in the surgical environment without the knowledge of the surgical team UNDERSTANDING WHAT YOU HEAR EMG ACTIVITY The TONE MENU is used to select whether EMG AUDIO EVENT TONES or both are audible Both EVENT TONES and EMG AUDIO can be ON at the same time but both features cannot be simultaneously disabled The EMG AUDIO signals are not influenced by the EVENT THRESHOLD Therefore all EMG activity regardless of amplitude is audible when the EMG AUDIO is ON The EMG activity may sound like a low pitched drumbeat at times When two channels are monitored at the same time it is unlikely that you will be able to differentiate the EMG signals as to their channel of origin strictly by the sounds they produce 21 EVENT TONES however is coded to distinguish the channel of origin Only signals with ampli tudes exceeding the EVENT THRESHOLD produce a tone The tone for Channel activity is lower in pitch than the Channel 2 tone and so on for channels 3 and4 This lets you tell by the tone s pitch which channel is involved When EMG activity exceeding the event threshold occurs at the same time on both channels only one of the tones sounds VERIFYING STIMULUS DELIVERY The NIM Response allows you to verify delivery of current both audibly and visually There may be times w
21. patient Check connectian at Patient Interface box gt 10KA for EMG Tube interface f 0 M Electrode impedance Q Positive and negative electrodes touching O OKW below surface af skin Extremely low impedance particularly in Use tap test near electrodes to evoke EMG or artifact 17 EMG tubes activity is noted on channel in question proceed Channel button is flashing gt Electrode laying on skin surface Re insert electrode in question Electrode reading is Electrode placement insecure or OFF Dirty electrode tip Remove and replace electrode in question i Electrode cable broken i 5 2 A Electrode pin disconnected from patient Check connection to Patient Interface box interface a SES SO SOS d Electrode difference is greater Dirty electrode Remove and replace electrode for appropriate channel with than 2KO subdermal Mismatched pair highest impedance reading first clectrodes or Prass Unequal placement Remove and replace electrode in question 1 22272 T l i Paired electrodes Muting Probe not connected Check Muting Probe connections Electrosurgical interference Muting Probe input insufficient Move input to MORE MUTE i Electrosurgical grounding inadequate Check electrosurgical grounding pad an patient Source of interference uniden
22. stress or pressure on the nerve and affect its function i WHEN MONITORING IS COMPLETE Turn OFF the power to the NIM Response Systen when the entire procedure is completed and have the Licensed Medical Practitioner remove the electrodes from the patient The disposable Prass Monopolar Stimulator Probe and patient electrodes must be discarded after surgery Wipethe PATIENT INTERFACE CABLE and the MUTING PROBE CABLE and visually inspect them for cracks and other damage If they are damaged return them for service 23 3 TROUBLESHOOTING SYMPTOM 7 CAUSE SOLUTION f No visual display or audio Power cord not connected 10 outlet orto the Plug in power cord alarms at power up NIM Response system has unexpected results Power switch not turned on Turn power switeh on Touching the screen changes poen screen out af calibration Turn unit off then press the sereen until the screen E i Screen to recalibrate gt 40 tor hookwire electrodes calibratian test is displayed Follow the instructions on the Electrode impedance istoo Electrode dislodged from patient but not Insert dislodged electrode tape down in place high completely out gt 10 for subdermal electrodes High resistance in electrode Remave and replace with new electrode gt 25 for Prass Paired electrodes Electrode pin not firmly inserted into
23. 15 1B Always store the NIM Response in a cool dry place 27 APPENDICES APPENDIX A GLOSSARY amp QUICK REFERENCE TERMS 28 ampere Unit of measure for electrical current One 1 milli amp will flow when one volt is connected across I K Ohm of resistance amplitude Quantitative microvolts measurement of the peak to peak height of EMG response anode _ The positive pole or electrode of an electrical stimulator remote needle in the case ofa monopolar stimulator and one of two poles on a bipolar stimulator See cathode artifact Any audio response or recorded visual display transmitted by the recording electrodes caused by something other than true EMG activity See stimulus artifact baseline EMG activity Ongoing low level EMG activity auditory and visual elicited from the target muscle s at rest biphasic waveform An EMG visual display with contiguous components which lie on either side positive and negative of the baseline See monophasic waveform bipolar stimulation Near field closely adjacent cathode and anode contact to neural tissue and current delivery which minimizes current spread to other structures or tissue Recommended for specific identification of close proximity of neural tissue 5 burst response Asynchronous non evoked response cathode The negative electrode of an electrical stimulator circuit The NIM Response deliver stimulating current in the cathode to anode
24. CE IMPROPER FLUSH CONTACT BETWEEN THE PROBE AND THE NERVE STIMULATOR RETURN ELECTRODE NOT CONNECTED OR OTHER INCOMPLETE ELECTRICAL CONNECTION BETWEEN THE NIM RESPONSE AND THE STIMULATOR PROBE AND STIMULUS SET 0 00 Patient CABLE Fuse 8 THE PROPER SETUP AND USE OF THE MUTING DETECTOR NEEDED FOR OPTIMUM MONITORING SHOULD YOU EXPERIENCE ANY DIFFICULTY WITH THE SENSITIVITY OF THE MUTING DETECTION RESULTING IN EITHER A CONSTANT MUTING SITUATION OR NOT ENOUGH MUTING WHEN THE ELECTROSURGICAL UNIT IS ACTIVATED ADJUST THE MUTING PROBE INPUT EITHER LESS MUTING LOWER MUTING PROBE GAIN REPRESENTED BY LOWER JACK NUMBER OR MORE MUTING HIGHER MUTING PROBE GAIN REPRESENTED BY HIGHER JACK NUMBER AS REQUIRED BY THE SITUATION i STIMULUS ARTIFACT MAY BE SPURIOUSLY DETECTED AS EMG EVENTS IF THE RECORDING ELEC TRODES AND THE STIMULATOR OR CABLING BECOME TANGLED BE CAREFUL TO ROUTE THE RECORDING ELECTRODES AWAY FROM STIMULATOR CABLES OTHER MONITORING EQUIPMENT SUCH AS THAT USED BY THE ANESTHESIOLOGIST MAY PICK UP THE SMALL CURRENTS USED DURING MUTING OR ELECTRODES CHECK FOR ONGOING ELECTRODE IMPED ANCE CHECKS IN MOST CASES THEIR PRESENCE CAN BE BY THE ANESTHESIOLOGIST OR OTHER MONITOR OPERATOR PROPER PLACEMENT AND SETUP OF THE ECU AWAY FROM THE MONITOR WILL REDUCE OR MINIMIZE MUTING OFF SETS AND INTERFERENCE Do NOT LET THE CONDUCTIVE PARTS OF APPLIED NEEDLE ELECTRO
25. CONNECTOR OPTIONAL The two footswitch adjusts the Stimulus up and down 4 MUTING PROBE INPUTS There are four MUTING PROBE INPUTS on the NIM Response Monitor One MUTING PROBE is shipped with the system 82 50000 Plug the MUTING PROBE into MUTING PROBE INPUT 3 5 POWER CORD The POWER CORD plugs into the back ofthe NIM Response Monitor Plug the POWER CORD into the A C power outlet 6 POWER SWITCH The POWER SWITCH turns the power ON or OFF 7 FUSE ACCESS Replace with 250V fuses only For 100 120 V wall power use 4 0 A fuses For 220 240V wall power use 2 0 A fuses 8 PATIENT INTERFACE CONNECTOR The PATIENT INTERFACE CONNECTOR is a 25 pin D sub connector which accepts the cable from the PATIENT INTERFACE BOX Plug the PATIENT INTERFACE CABLE securely into the back of the NIM Response at the PATIENT INTERFACE CONNECTOR and tighten the thumb Screws 9 LANGUAGE SWITCH The LANGUAGE SWITCH is set to English by default It may be switched to French ltalian German or Spanish as needed 10 FACTORY CUSTOM MODE SWITCH The Factory Custom mode switch allows the unit to be retumed to original factory settings To reset the soflware to Factory mode move the switch to F and then power the unit ON The normal mode is Custom which allows the user to save Custom configurations 11 ACCESSORY POWER OUTLET The Accessory Power Outlet powers perpipheral devices used with the NIM
26. DES CONTACT EACH OTHER PROPER DETECTION OF EMG AGTIVITY MAY NOT OCCUR PROPER NIM RESPONSE OPERATION CANNOT BE GUARANTEED IF YOU DO NOT USE MEDTRONIC XOMED STIMULUS PROBES STIMULUS DISSECTION INSTRUMENT S OR ELECTRODES AFTER NEEDLE INSERTION AND BEFORE THE PATIENT IS DRAPED AFTER THE INCISION I CLOSED AND BEFORE THE SURGICAL DRAPES AND ELECTRODES ARE REMOVED GHECK THE ELECTRODE INTEGRITY BY PRESSING ELECTRODES CHECK THIS CONFIRMS THAT RECORDING ELECTRODE CONTINUITY WAS MAINTAINED THROUGHOUT THE ENTIRE PROCEDURE v CUSTOMER SERVIGE U S GUSTOMER SERVICE General customer service and technica support are available toll free 800 874 5797 or 904 296 9600 Monday Friday 8 00 AM 6 00 PM E S T www xomed com MICROELECTRONICS REPAIR Technical Support Return Address 800 872 9877 Medtronic Xomed Surgical Products Inc 904 296 6448 FAX 6745 Southpoint Drive N Monday Friday Jacksonville FL 32216 8 00 AM 5 00 PM E S T Atm Repair Department www xomed com INTERNATIONAL SERVICE International customers should contact their Medtronic Xomed office AUSTRALIA 800 062 289 CANADA 800 710 5201 FRANCE 0470 670451 U K 01454 619555 GERMANY 08105 3755 0 or their distributor THE NIM RESPONSE HELPLINE Should you need immediate help with a technical question or guidance through the appropriate protocol just call the NIM Response Help Line at 1 800 874 5797
27. Filed on behalf of Medtronic Inc UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Medtronic Inc Petitioner v NuVasive Inc Patent Owner Case U S Patent No 8 016 767 DECLARATION OF DAVID HACKER MSD 1015 1 David Hacker of Duval County Jacksonville Florida declare that 1 I am the Principal Engineer Research and Development for Medtronic Inc in the Surgical Technology Division I have worked as an engineer on Nerve Integrity Monitor NIM systems for surgical applications since 1989 Specifically from 1989 to 1999 worked on NIM systems for Xomed Inc In 1999 Xomed Inc was acquired by Medtronic Inc I have continued to work on NIM systems for Medtronic Inc since that acquisition 2 My work on NIM systems has involved reviewing user manuals that are provided with the NIM products sold by Medtronic Inc and previously Xomed Inc These user manuals are shipped with the corresponding product to customers who buy the product 3 Being submitted with this Declaration as Attachment A is one such manual which is entitled NIM Response Nerve Integrity Monitor Intraoperative EMG Monitor User s Guide User Guide The User Guide was a user manual for the NIM Response 82 50001 Mainframe product NIM Response product and was shipped with the product to customers 4 The User Guide has a copyright date of 2000 on the page following the title pag
28. I Medical Device per IEC EN6060 1 1 RADIATED ELECTROMAGNETIC FIELDS Complies with 60601 1 2 The system is intended to be used with the Muting Probe which generally activates the MUTE function synchronous with exposure to excessive RFI energy During Muting the audio and visual displays are disabled After removal of the RFI the muting turns off and monitoring automatically continues Certain sources and low levels may not be detected by the muting detector and may activate the mute function Users of this equipment should be aware that if the Muting Probe is not used or is not activated by tlie RFI then the monitor as a result of the interference may output audio and visual interference artifacts When the unit was RFI tested without the Muting Probe artifact was heard from the speaker and seen on the display for RFI levels from I V m 80 AM KHz to 3 V m for 2610 1000 MHZ Artifact will typically produce screen and or speaker output that has characteristics unlike repeat able evoked EMG responses The user should confirm that the responses are not RF induced and that EMG clearly correlates with an expected patient EMG response in the context of the surgery RFI artifact responses cannot convey improper infoimation since the aberrant signal is easily recognizable by the surgical team t APPENDIX REFERENCES Beck Douglas L MA and Benecke James E Jr MD FACS Intraoper ative Facial Nerve Monitoring Technical Aspec
29. L 300 ASSEMBLE TXT 0001 1 ASSEMBLE NIM MAINFRAME PER XMI 206 054 Ey 7 EE 2 20 4213 206 OSA ks o4 TO wu SU M L L 10 000 FUNCTIONAL TEST TXT 0001 1 PERFORM NIM FUNCTIONAL TEST PER XES 0337 SECTION III A 5 7 TO 30 2587 206 06A WSF 7 6 SU M L RT M 040 L 10 000 BURN IN TXT 0001 1 PERFORM NIM BURN IN TEST PER XES 0337 SECTION III B 5 25 22 40 0158 206 06A 5 20 E f SU M L L 500 TEST MAINFRAME ASSEMBLY TXT 0001 1 SYSTEM SECURITY REMOVE COVER AND VERIFY ALL TXT 0002 CABLES BOARDS AND COMPONENTS ARE SECURE TXT 0003 100 t INSPECT VISUAL ACC 2 RET TXT 0004 0 TXT 0005 2 PERFORM NIM FINAL TEST PER XES 0337 SECTION III AND IV FOR ONE TXT 0006 UNIT TEST REMAINING UNITS PER XES 0337 SECTION III ONLY TXT 0007 TXT 0008 100 INSPECT VISUAL ACC 2 pr O de AG M ab 2 50 7573 206 06A xp cm SU M L RT M L 2 000 Q A INSPECT TXT 0001 1 INSPECT PER THE FOLLOWING TXT 0002 SYSTEM VISUAL VERIFY BURN IN PERIOD COMPLETED AND VISUALLY TXT 0003 INSPECT POWER SWITCH FRAME DECALS JACKS amp LCD FOR TXT 0004 APPEARANCE amp ALIGNMENT PLACE CUSTOM NORMAL SWITCH IN THE C H R DEPT REVIEWED Mate TH M 442 COORDINATOR 4 Intraoperative EMG Monitor USER S GUIDE NIM Response Helpline 1 800 874 5797 For Questions and Service 4 Medtronic Xomed Surgical Prod ucts Inc 6743 Southpoint Drive North Jacksonville Florida 32216 0908 U S A
30. MULATOR PROBE plugs into the black cathode stimulus jack on the PATIENT INTERFACE BOX Since the stimulator probe and cable must be sterile for surgical applications the stimulator may be connected at the beginning of the procedure in the event the PATIENT INTERFACE BOX is not accessible later on in the case The surgeon should test probe for current delivery as soon into the case as possible This is done by selecting a stimulus intensity on the NIM Response front panel greater than 0 00 mA as indicated on the STIMULUS mA portion of the screen An intact circuit results in corresponding numbers approximating set amount in the MEASURED mA portion of the screen SYSTEM CHECKS AND TESTS These checks and tests should be performed for every case before the NIM Response is connected to the patient POWER UP TESTS An internal integrity check is automatically performed each time the system is turned ON You see a series of messages on the display screen The software version number and revision date are displayed briefly then the NIM Response does a series of self iests on the hardware Master Processor Pragram Master Processor RAM Touch Controller Program Touch Controller RAM Slave Processor RAM Slave Processor EPROM System Watchdog Timer System Parameter RAM Hardware Test Results If any self test fails call MEDTRONIC XOMED U S Customer Service toll free at 1 800 874 5797 If you are outside the United States
31. NOTE WHEN CONTACTING OUR CUSTOMER SERVICE AND TECHNICAL SUPPORT PLEASE HAVE THE APPROPRIATE PRODUCT NUMBER PRODUCT SERIAL NUMBER DATE OF PURCHASE AND NATURE OF INQUIRY AVAILABLE PRODUCT NUMBER SERIAL NUMBER DATE oF PURCHASE vi WARRANTY This product is sold by MEDTRONIC XOMED under the warranty herein set forth The warranty is extended only to the buyer purchasing the device directly from MEDTRONIC XOMED MEDTRONIC XOMED warrants this product to be free from defects in workmanship and material under normal use and service and shall conform to its original specifications for a period of one 1 year from the date of delivery The liability under this warranty is limited as is sole discretion to replacing repairing or issuing credit adjusted to reflect the age of the product for a system or a portion thereof provided that MEDTRONIC XOMED is notified in writing within thirty 30 days following discovery of a defect by the buyer b the defective device is returned to MEDTRONIC and MEDTRONIC examination of the device shalt disclose to its satisfaction that the device has not been repaired or altered by anyone other than MEDTRONIC XOMED ii any defect has not been caused by mis se neglect or accident iii the device has not been operated under conditions other than normal use and iv prescribed periodic maintenance and services have been performed with respect thereto THIS WARRANTY
32. PRESENCE OF FLAMMABLE ANESTHETICS TO MINIMIZE THE RISK OF BURNS TO THE PATIENT INCLUDING CASES WHERE MORE THAN ONE SUR GEON IS OPERATING FAT HARVESTING NEVER LEAVE THE STIMULATOR IN THE FIELD ON A MAGNETIC TRAY OR IN THE ELECTROSURGICAL HOLDER DURING ELECTROSURGICAL USE TO AVOID EYE INJURY DURING ELECTRODE PLACEMENT THE ELECTRODE NEEDLES SHOULD BE DIRECTED AWAY FROM THE ORBIT WHEN INSERTED FOR ORBICULARIS OCULI MONITORING DO NOT TURN POWER TO THE NIM RESPONSE ON WHEN THE STIMULATOR IS IN THE FIELD UPON APPLICATION OF POWER A PULSE OF 5 MA MAY BE DELIVERED FOR LESS THAN 0 01 S THis MAY BE EXCESSIVE FOR SOME MONITORING APPLICATIONS ANY CONNECTIONS MADE TO LPT1 OTHER THAN THE THOSE RECOMMENDED IN THIS MANUAL MAY NOT BE ISOLATED AND RESULT IN INJURY TO THE PATIENT OR OPERATOR THE NIM RESPONSE DOES NOT PREVENT THE SURGICAL SEVERANCE OF NERVES MONITORING iS ONLY A TECHNICAL AID TO IDENTIFICATION AND LOCATION OF NERVES IT DOES NOT REPLACE THE SURGICAL SKILLS EXPERIENCE AND ANATOMICAL KNOWLEDGE NECESSARY TO VISUALLY LOCATE NERVES AND SURGICALLY AVOID THEIR SEVERANCE PRECAUTIONS NOT CONNECT ANY DEVICE OTHER THAN NIM Response MUTING PROBES INTO ANY OF THE FOUR MUTING PROBE INPUTS on THE REAR PANEL OF THE NIM RESPONSE SYSTEM DAMAGE MAY RESULT DO NOT NIM RESPONSE OR EXTEND THE CABLES OF THE MUTING PROBE or PATIENT INTERFACE Suck MODIFICATIONS OR EXTENSIONS COULD SIGNIFICANTLY AFFECT
33. PROBLEM WITH THE NIM RESPONSE NOTE When contacting our Customer Service and Technical Support please have the appropriate product number product serial number date of purchase and nature of inquiry available Product Number Serial Number Date of Purchase A system that is not functioning properly SHOULD NOT BE USED AT ALL until all necessary repairs have been made and the unit has been tested to ensure that it is functioning in accordance with published MEDTRONIC XOMED specifications To avoid negating the warranty repairs should be performed by MEDTRONIC XOMED You liave sole responsibility for any malfunction resulting from improper maintenance or repair by anyone other than qualified MEDTRONIC XOMED personnel U S CUSTOMERS Should your monitor or related equipment malfunction MEDTRONIC XOMED provides at no charge loaner equipment shipped to your facility by UPS or Federal Express for use while your equipment is being repaired by MEDTRONIC XOMED Please adhere to the following guidelines When a loaner mainframe is ordered REF 53 50001 please reuse the shipping material and carton when you return your monitor to MEDTRONIC XOMED Insure the unit When a loaner is not ordered please package the monitor as safely as possible and insure A return goods authorization number is not required on repairs A copy of your purchase order is required Make certain the purchase order includes the followin
34. SELECTION When selecting recording electrodes the following questions should be considered What muscle group s is are being monitored How will the electrodes be secured Issubdermal or intramuscular placement more appropriate There are several electrode styles available for monitoring electromyography You may need to try different types to determine a preference A ELECTRODE PLACEMENT Eleetrode placement should be performed by or under the direction of a licensed medical practitio ner Areas of electrode insertion should be prepped by vigorous cleaning with an alcohol wipe Usually recording electrodes are placed before the sterile field is draped and defined Never let electrode leads contact one another The exact location for the electrodes is defined relative to the surgical procedure being monitored For all facial nerve monitoring the patient ground electrode may be located on the patient s upper chest sternum The placement for the anode electrode for the monopolar stimulating probe is on the ipsilateral shoulder Once the electrodes have been placed and secured with tape the connector end may be inserted into the input jacks on the PATIENT INTERFACE BOX A WARNING To AVOID EYE INJURY DURING ELECTRODE PLACEMENT THE ELECTRODE NEEDLES SHOULD BE DIRECTED AWAY FROM THE ORBIT WHEN INSERTED FOR ORBICULARIS OCULI MONITORING 18 ESA STIMULATOR PROBE CONNECTION The cable ona MONOPOLAR STI
35. Sereen sisis resisae aa aari aeria E A a iaia ie 6 2 ep ve voee 7 Auto Event Threshold c TT TT 7 Main 1 akse 8 Reference Channel siririn uesia da LEADS A 10 Quick Set Up Menu tnra H Customize Menu erreressrrersvavrerrerrenrsessrsvernvevanevrensesavrsvesesreveerr 12 Stimulus Submenu Voices Submenu Tones Submenu Glock Submenu i uc dete ceto eva ee me kuju eee ee Rn toa te en eine degens 15 Research Tools Submenu esee dats 16 2 Using The NIM Response 9 5009 18 Anesthesia Requirements 2 202474 0 nies views 18 Electrode Selection essent SA 18 Electrode Placeineit scaccicceseccsescocdeesavecoscsseabies 33 13 00 18 Stimulator Probe Connection P EMEN a 19 System Checks And Tests 19 Electrode Impedance Checking 3 19 Adjusting The Event Threshold 2 aesan Spara 0 20 When Electrocautery And Cusa Are Used 21 Understanding What You Hear
36. TOMIZE is used for modifications to the listed features The NIM Re sponse continues monitoring while settings on the configuration menus are being changed The STIMULUS appears at the top left corner of the display and controls the stimulating current delivered by stimulator probes when connected to the NIM Response The range of output is 0 0 to 3 0 mA While below 0 10 mA the setting is adjustable by increments of 0 0 mA while above 0 10 mA it is adjustable by 0 05 mA The default STIMULUS setting is 0 00 mA Research fools Exit B Stimulus ODOMA Measured Stimulus Setting Control To adjust the STIMULUS intensity press the setting button You see the setting flash The setting can then be adjusted by either touching the graphical scale or touching the or buttons The new setting is indicated on the setting button while it 15 being adjusted and is also indicated by the relative position of a small vertical bar on the relative scale The MEASURED value which appears in the top right corner of the display screen reflects the amount of stimulating current flowing through the patient and should approximate the STIMULUS value is displayed in milliamps mA The MEASURED value may fluctuate between 0 00 mA 0 05 mA until contact is made by a probe Stimulus Submenu 12 STIMULUS RATE Stimulus The rate of stimulation is adjustable The stimulus pulse can be delivered al a STIMULUS DURATION rate of eith
37. TUP settings are displayed along with the statement Select Physician Initial Settings These settings may need to be adjusted as the surgery progresses Any of the saved Physician Settings may be selected however if no selection is made within 10 Seconds the settings of the highlighted names are activated The main monitoring screen is then displayed Verify that the STIMULUS and EVENT THRESHOLD values the physician desires are set CHECK ELECTRODE ALERT During power up the NIM Response automatically turns ON each channel that has an electrode connected from the patient to the PATTENT INTERFACE BOX When no electrodes are plugged into the PATIENT INTERFACE BOX the NIM Response warns you in 20 S that an electrode lead is not making proper electrical contact OFF You then hear the Bleedle Alarm The channel button flashes continuously until the electrode is placed or the channel is turned OFF The electrodes screen is displ yed showing which electrodes are OFT The NIM Response checks all the electrode leads every 1 2 S during MUTING and ELECTRODES CHECK by sending 60Hz pulses through the leads It reads the impedance of each lead and verifies that the readings are within normal range When the electrode impedance levels are too high MUTING turns on and the CHECK ELEC TRODES Bleedle Alarm sounds The indicator light of the affected channel flashes The ELEC TRODES screen is displayed and indicates which electrodes are outside of normal
38. ble capture mode indicator on touchpad 50 mS or 10 Sec display modes APPENDIX D TECHNICAL SPECIFICATIONS CONTINUED STIMULATOR Stimulus Type Constant Stimulus Range Stimulus Control Stimulus Adjustment Stimulus Measurment STIMULUS CHARACTERISTICS Waveform Duration Rise Time Rate Stimulus Probe Aupio OUTPUT Transducers EMG amp Event Tone Signals Volume Preset and Limiter Constant Current 0 3 mA maximum 12 V compliance Digitally controlled adjustable in 01 05 2 mA steps Dedicated Adjustable Graduated Touch Bar with digital readout on display of command current and delivered current 01 3 0 mA 02 mA Monophasic square pulse Switch selectable 50 100 or 250 pS Less than 0 1 mS Switch seleciable 1 4 7 or 10 Hz Monopolar standard or bipolar optional Built in 4 0 inch speaker Continuously processed EMG and or activity level dependent event tones each channel Volume Power Up Pre set Default and a Low Volume Limiter Current Delivered Tane Signal Warble Tone 05 3 mA Measure Current gt 80 Set Current Printer Ourpur Disk DRIVE OUTPUT Printer Interface Connection Isolation VIDEO OUTPUT Interface Connection Video solation ELECTRICAL Voltage Frequency Power Consumption Auxilarv AC output Linc Isolation Patient Connections Class Hewlet Parkayd Model DeskJet 340 printer PCLS compatible C2655A Ce
39. ctor 31m Regular Ea 13 52413 KSD Ring Dissector 2mm Regular eee I lia Neurotologic Stimulus Disseetion Instrument Sec 2 I Set Includes 13 53401 NSD Right Angle Pick 5 13 53402 NSD Right Angle Pick Long 13 53403 NSD Curved Needle 13 53404 NSD Duckbill Elevator Medium 13 53405 NSD Elevator Wide 13 53406 NSD Round Knife 3 mm 13 53407 13 53408 NSD Round Knife 5 MM RR 13 53409 NSD Raspatory Narrow Right 13 53410 NSD Raspatory Narrow Leli 13 53411 NSD Raspatory Medium Right s 13 53412 NSD Raspatory Medium Left 00 7 IPM 33 APPENDIX B NERVE MONITORING ACCESSORIES CONTINUED ORDER NO DESCRIPTION 13 53413 NSD Raspatory Wide 13 33414 NSD Raspatory Wide Left 13 52415 Cable Protected Pin annnka aortae AES A Eara A ie esii 13 52396 OTHER STIMULUS DISSECTION INSTRUMENTS 13 52408 Sickle Knife S VINE 13 52409 90 Hook LOMM 7 3 3 3 3 3 3
40. e I note that the User Guide has a date of 03 00 on the last page This indicates that this version Revision B of the User Guide was finalized in March 2000 The User Guide also has a handwritten 4 4 2000 notation at the top of the title page This indicates that the User Guide was approved for release with the corresponding product on April 4 2000 5 In addition I have attached a copy of a Work Order for the NIM Response product as Attachment B to this Declaration Work orders document the date that a product was built and includes among other things the first and last page of the 1 user manual that is included with the product when the product is shipped The attached Work Order is for a NIM Response product built in May 2000 and has a Lot No 19727500 The first and last page of manual attached to the Work Order confirms that the manual shipped with the product was the same User Guide as Attachment A The date stamped at the bottom of the Work Order indicates that the NIM Response product with this particular User Guide was built and ready for shipment on May 26 2000 6 I attach as Attachment C to this Declaration a Sales Record for the NIM Response product for May 26 2000 I note that the Lot No is the same as that of the Work Order above Lot No 19727500 This Sales Record confirms that on May 26 2000 the product and the accompanying User Guide was shipped to customers 7 I have also attached a copy o
41. e unit Verticle Scale Indicator and Control EVENT CAPTURE displays on the 50 mS screen any EMG activity that exceeds the EVENT THRESHOLD This waveform is displayed until it is replaced by the next event Touching the EVENT CAPTURE turns this feature ON and OFF VOLUME The VOLUME control adjusts the speaker Upon Power Up the VOLUME is automatically set at a moderate level VOLUME cannot be turned completely OFF VOLUME is adjusted by touching the graphical volume scale The setting is indicated by relative position of a small vertical bar i Volume Control REFERENCE CHANNEL REFERENCE CHANNEL is used as an additional means ofartifact determination The REFERENCE CHANNEL compares active EMG channels to a neutral or reference channel When activity on the REFERENCE CHANNEL is detected greater than EVENT THRESHOLD at the same time there are Events on an EMG channel the REFERENCE ACTIVITY is detected and is announced Place the two REFERENCE CHANNEL electrodes in a muscle not affected by manipulation ofthe nerve being monitored For example wlien monitoring the right facial nerve the reference elec trodes could be placed in the left obicularus oris muscle Activity on the REFERENCE CHANNEL may be from other equipment causing interference It may also may be from global evoked or spontaneous neuro motor activity like the patient becoming light QUICK SETUP MENU Quiet Setup SELECT UPDATE ADD REMOVE Ouick S
42. electrodes in innervated muscle Nerve not stimulable Unexplained continuous train EMG response Nerve or monitoring area being simulated or manipulated by thermal or mechanical means Metal to metal discharge artifact stimulator wires H i Intertwined recording electrode and Inadvertent manipulation of electrode wires Patient Interface cable or recording area patient en Electrical interference from other equipment EE Excessive current shunting in surgical field 77 SOLUTION Move the Muting Probe connector to a higher number until it mutes still does not mute in position 74 loop the ESU cable and clip the muting detector over the doubled cable Increase stimulus intensity Eliminate paralyzing anesthetic Check that Stimulus Measure is approximately the same value as the Stimulus senting Re insen electrode in question i Secure all recording and stimulating electrode connections and check the impedance values Check stinulator anode and cathode connections A A E Check Ruse in Patient Interface box 32 mA x 250V Replace il necessary f Hold probe tip 10 nerve for at least 1 S Check stimulator tip for obstruction Replace if necessary Check location af stimulation stimulus intensity Remove fluids from surgical stimulatinp arca Place channel electrodes in muscle to be monitored Identify
43. en subdermal needles 82 27 101 per package Packaged sterile in individual pouches Intended for single use only 82 27301 25 mm Protected 5 Pkg Box 82 27304 18 mm Protected 5 Pkp Box 32 APPENDIX B NERVE MONITORING ACCESSORIES CONTINUED ORDER NO DESCRIPTION NO UNIT SUBDERMALIEEG NEEDLE ELECTRODES LENGTH 12 mm DIAMETER 0 4 mm SMALL DIAMETER HUB Protected Pin 82 27103 Stainless Steel 1 0 meter cable n meemeerenrrsrmoeeesrerrererrevsrrrersesversesernatenss nenrvsntravereveeererssrsserser sensorer 6 Box Packaged sterile in individual pouches Intended for single use only EMG HOOKWIRE ELECTRODES 82 26325 82 26326 82 26625 82 26626 82 30000 EMG Paired Hookwire Electrode ennervevnerasserersvvasevesenssseprervssvsngsresssenesneressrsesesrsenararsersevsssssasennavanesereer 2 Pr Box Needle length 25 mm Wire length Im 2 mm pin connectors Packaged sterile in individual pouches Intended for single use only EMG Paired Hookwire Electrode Protected Pin 333 3 3 3 3 33 1 1 tenen enn 2 Pr Box EMG Single Honkwire Electrode 2 2 1 2 24 4 0 1 1 0001 40 66 066 6 Box Needle length 25 mm wire length Im 2 oin pin connectors Packaged sterile in individual pouches Intended for single 050 only EMG Single Hookwire Electrode Protected Pin
44. er 1 S 4 S 7 S or 10 S The default rate is 4 S The duration of stimulation is adjustable The stimulus pulse lasts either 50 US 100 uS or 250 uS The default duration is 100 pS M 5 STIMULUS FILTER STIMULUS FILTER displays a window showing where the stimulus artifact delay ends and real EMG data begins The STIMULUS FILTER can be set for values of 1 00 mS to 4 10 mS The default is 3 10 mS STIMULUS FILTER Stimulus Ftitor 3 20mS DEFAULTS Setting Default Other Options Stimulus Rate 3 3 20 Bs VS 7 5 10 6 Stimulus Duration VO HS nes 50 5 and 250 5 Stimulus 3 10mS sss 1 00 104 10mS Voices Submenu The VOICES controls the voices produced by the NIM Response as SER follows i Electroug HELP VOICES Muting Audible HELP voices can be turned ON or OFF via the Voices submenu When the HELP voices are turned ON you can select specific voices When the HELP voices option is turned OFF help voices are OFF Check Electrode Voice When an electrode is not detected the CHECK ELECTRODE alarm sounds This could be due to electrode not placed electrode falling out of patient the electrode not properly seated in the Patient Interface or a defective electrode When this voice is turned OFF only the Bleedle alarm sounds Muting Voice While the electrocautery is in use the MUTING voice and Bleedle alarm sounds after 30 Second
45. etup Menu provides access to configuration of features The settings configurations can be modified in the following g ways SELECT UPDATE EN ADD and REMOVE Quick Setup configurations can be chosen by pressing SELECT A list of stored settings is displayed Press the configuration and then press SELECT The active Quick Setup configuration is displayed on the SELECT button of the Quick Setup Menu Remove To UPDATE an existing configuration verify the configuration that is active which is displayed on the SELECT button of the Quick Setup Menu Adjust feature settings such as Stimulation Event Threshold Event Capture and then press UPDATE This saves these settings of this Quick Setup configuration ae pe EE TT To ADD configurations preferred by the surgeon adjust feature settings such as Stimulation Event Threshold Event Capture and then press ADD on the Quick Setup Menu A keyboard is displayed to allow the entry of the name of the physician or the procedure configurations Press Accept to save these settings under the name that was typed Pressing X exits this interface without saving Quick Setup configurations can be deleted by pressing REMOVE A list of stored settings are displayed Select the setting to be removed and then press REMOVE 11 CUSTOMIZE MENU STIMULUS CUS
46. f Work Order History from 2000 2001 for the NIM Response product as Attachment D to this Declaration The Work Order History shows that the NIM Response product was continuously built and shipped with accompanying manual throughout 2000 2001 At least as early as May 26 2000 the manual shipped with the product was the User Guide 8 Thus based on my review of the User Guide Work Order Sales Record and Work Order History the User Guide was provided to customers outside of Medtronic Inc who bought the corresponding product at least as early as May 26 2000 Those customers included hospitals and clinics in the United States and other countries Medtronic Inc did not restrict the customers use or dissemination of the User Guide 9 I hereby declare that all statements made herein of my own knowledge are true and that all statements made on information and belief are believed to be true and further that these statements were made with the knowledge that willful false 2 statements and the like so made are punishable by fine or imprisonment or both under Section 1001 of the Title 18 of the United States Code Date A0 2047 VALE David Hacker ATTACHMENT A Aap eie Noe Approvat i NIM Response NERVE INTEGRITY MONITOR Intraoperative EMG Monitor USER S GUIDE NIM Response Helpline 1 800 874 5797 For Questions and Service 0131 3
47. format selection When i the unit is in the process of saving the button will display either SAVING IMAGE or SAVING DATA The FORMAT of information saved to disk can be either an IMAGE file ora DATA LOG The IMAGE file is stored in PCX format The DATA LOG file contains the time and X and Y data in an ASCII comma delimited format The default FORMAT is IMAGE DEFAULTS Setting Default Other Options Output Device LS 120 Zip fete Largest Freeze Measurement Cursor On Channel Mute mm Off On 17 2 USING THE NIM RESPONSE ANESTHESIA REQUIREMENTS All decisions regarding anesthesia are the responsibility of the attending licensed medical practitio ner administering the anesthesia Because all intraoperative monitoring discussed in this User s Guide requires that EMG activity be recorded from a muscle or muscles it is important that the niuscle s not be paralyzed during the surgery or at least during those parts of the surgery when the nerve s being monitored is are deemed at risk by the surgeon It is important that the surgeon discuss these issues preoperatively with the attending licensed medical practitioner administering the anesthesia WARNING THE USE OF PARALYZING ANESTHETIC AGENTS WILL SIGNIFICANTLY REDUCE IF NOT COMPLETELY ELIMI NATE EMG RESPONSES TO DIRECT OR PASSIVE NEURAL STIMULATION ELECTRODE
48. g Shipping and billing information Purchase order number Contact person Phone number Description of malfunction Your MEDTRONIC XOMED account number Please indicate preferred method of return shipment Otherwise the unit will be shipped back via UPS ground When the malfunctioning unit is not covered by warranty MEDTRONIC XOMED will contact your facility promptly with a repair cost estimate if requested The customer will be responsible for freight charges on non warranted units e When you have loaner equipment and you receive your repaired unit please package the loaner equipment as safely as possible using the foam provided with your repaired equipment Include paperwork indicating the unit is a loaner and MEDTRONIC will credit your account Loanerequipment not received by MEDTRONIC within 30 days from the date repaired equipment is shipped will be invoice at full purchase price THE PRINTER STORAGE The Printer if purchased through Medtronic Xomed should be returned directly to Hewlett Packard for repairs or service The Hewlett Packard U S Customer Support phone number is 208 323 2551 Additional telephone numbers addresses and other details may be found in the Hewlett Packard Printer User s Manual shipped with the printer Concerns or question regarding second party printers should be directed to the respective manufacturer Second party printers must comply with FCC Part
49. haracteristics of a waveform proximal Closer to the center relative to a fixed point versus dista e g the facial nerve as it exits the brainstem is proximal to where it courses through the mastoid pulse response Repetitive evenly spaced responses usually synchronous with electrical stimulus 30 APPENDIX A GLOSSARY amp QUICK REFERENCE TERMS CONTINUED resistance A property of a conductor which causes it to impede the flow of electrons See impedance sensory nerve Nerve which rerminates in a sensory end organ e g hearing or vision or serves as a sensor nerve for pain and heat stimulus artifact Auditory and or visual responses which are caused by the pulsed output of an electrical stimulator time display window Horizontal scale on the NIM Response oscilloscope displayed in either a compressed 10 sec or expanded 50 mS mode response Continuous irregular responses which usually crescendo up and down in intensity and frequency voltage The force that causes electrodes to flow through a conductor i volt Unit of measure of the intensity of force moving through a conductor Microvolt UV 1 1 000 000th of a volt 31 APPENDIX B NERVE MONITORING ACCESSORIES ORDER NO DESCRIPTION NO UNIT NERVE INTEGRITY MONITOR 82 50110 NIM Response HP Printer Ss LS 33311110 1 Ea Includes 82 40100 NIM Response HP Printer ementi 0
50. hat are damaged or modified by anyone other than MEDTRONIC XOMED Federal law in the U S A and Canada restricts the sale distribution or use of this device to by or on the order of a licensed medical practitioner er 4 GETTING STARTED DEVICE DESCRIPTION INTENDED USE The NIM Response is intended for use in surgical operating theaters for patient conmected intraoperative nerve monitoring INDICATIONS The NIM Response is intended for intraoperative use during surgeries in which a motor nerve is at risk due to unintentional manipulation The NIM Response records lectromyographic EMG activity from muscles innervated by the affected nerve The monitor will assist early nerve identifi cation by providing the surgeon with a tool to help locate and identify the particular nerve at risk within the surgical field It will continuously monitor EMG activity from the muscles innervated by the nerve at risk to minimize trauma and enhance neural preservation by alerting the surgeon when a particular nerve has been activated CONTRAINDICATIONS The NIM Response is not for use when paralyzing anesthetic agents are being used since they will significantly reduce ifnot completely eliminate EMG responses to direct neural stimulation COMPONENTS When you unpack the NIM Response save the cartons and packing material in which your monitor arrived If the instrument is to be shipped from one location to another the custom designed sh
51. he preventive maintenance schedule outlined below Your own schedule may vary from this schedule based upon the type and amount of system use CLEANING THE NIM RESPONSE SYSTEM Remove dust on the outside of the instrument with a soft brush or cloth Remove any remaining debris with a soft cloth that has been slightly dampened with alcohol VISUAL INSPECTION Check the NIM Response System occasionally for exterior damage Only qualified MEDTRONIC XOMED service personnel should replace damaged parts AFTER EACH USE Wipe the PATIENT INTERFACE CABLE MUTING PROBE CABLE S and NIM Response clean and visually inspect for any damage Clean any substance from the PATIENT INTERFACE BOX making sure that nothing is forced into the electrode connector sockets SERVICE AND REPAIR PROCEDURES MEDTRONIC is connnitied to provide the highest standard of workmanship manufac turing the NIM Response System Your NIM Response requires a minimal amount of maintenance however MEDTRONIC XOMED recommends preventive maintenance and calibration scheduled at yearly intervals The Mainframe Biomedical Verification Test Procedures should be performed at least annually and whenever a problem is suspected Comprehensive testing and calibration should be performed by returning the entire system including the patient interface and muting probe to Medtronie Xomed Repair Department 6743 Southpoint Drive N Jacksonville Fl 32216 IF YOU SUSPECT A
52. hen the surgeon has placed the probe into the surgical field expecting an EMG response and none is evoked When this occurs and the nerve has functional intergrity and was properly stimulated you must check that a stimulus current was actually delivered to the field One of the features of the NIM Response is the STIMULUS Tone option which is selected from the TONES MENU When stimulus is delivered but no events are evoked the STIMULUS WARBLE TONE indicates that current has been delivered to the surgical site EVENT TONES override STIMULUS TONES This can be set to BRIEF CONTINUOUS VOICE or OFF Stimulus delivery can be visually confirmed by comparing the STIMULUS and the MEASURED readings The MEASURED reading is found on the upper right hand side of the screen next to STIMULUS The value should be approximately the same as the STIMULUS SETTING RECOGNIZING ARTIFACT The NIM Response features sophisticated artifact rejection technology designed to provide highly sensitive and accurate monitoring The technology encompasses electrocautery detection overload detection and stimulus artifact rejection associated with the stimulating MONOPOLAR probes The signals associated with these conditions are automatically muted and will not be heard However there may be electrically generated signals in the range of true responses that cannot differentiated by the NIM Response For example a transcutaneous stimulator used by the anesthesiologist
53. hical scale or touching the or buttons The new setting is indicated on the setting button while it is being adjusted and is also indicated by the relative position of a small vertical bar on the relative scale Event Threshold Setting Control AUTO EVENT THRESHOLD In a situation where the EMG has been elevated for a few seconds the EVENT TONES beeps stop being helpful and simply become noise The NIM Response cau automatically adjust the EVENT THRESHOLD to maximize information from the EMG and minimize unnecessary noise The EVENT THRESHOLD is a filter that brings more significant events to the surgeon s attention while hearing the raw EMG from less important ones The AUTO EVENT THRESHOLD can help the surgeon use the most sensitive settings possible i The AUTO button is next to the EVENT THRESHOLD setting and has a square to indicate whether itis selected The default is OFF The EVENT THRESHOLD remains the same for all channels until part of the baseline ofan active i EMG channel increases above the EVENT THRESHOLD for more than 5 10 S of numerous event tones sounding When detected BASELINE INCREASED is announced the EVENT THRESH OLD of each effected channel is adjusted relative to it s baseline and the text AUTO flashes The AUTO EVENT THRESHOLD setting of each channel is displayed on the right hand side of the Screen Raw EMG from each channel is still audible The threshold automatically tracks an increasing
54. ibration the NIM Response enters its normal operating mode DEFAULTS Setting o Default Other Options Channel 1 4 and Reference Channel Manual eee SOMS 10S Vertical Scale 0 2004 V 2000 uV Stimulus ees 001 mAto3 00mA Event Threshold es 20 02500 Auto Event Threshold eos 2 5 On Event Capture Off ennt sesse 0 100 MAIN MENU The Main Menu is displayed on the right hand side of the screen white the unit is in monitoring mode The Main Menu allows the user to adjust many of the software features ELECTRODES ELECTRODES displays the impedance of electrodes and difference of their impedances for Channel 1 through 4 electrodes as well as Ground and Anode electrodes While the ELECTRODES screen is displayed monitoring does not occur and the speaker is muted The words WARNING MONITORING IS DISABLED blink in reversed text to alert the user After 30 Seconds the MUTING voice is heard tins 165103 Electrodes Chae Ditteresce 2 2 2 Ottererse Reserence C Ollerence Subdorms Peace P 4020 lt Electrodes ELECTRODE PLACEMENT ELECTRODE PLACEMENT displays the electrode placement to monitor cranial motor nerves by touching the co
55. ipping package will provide the best protection When the box is unpacked check off the contents of the box against the items listed on the packing slip If the contents are incomplete or if there is damage notify MEDTRONIC XOMED If the shipping container is damaged or the cushioning material shows signs of stress notify the carrier as well Keep the shipping materials for carrier inspection Ensure that the following components are present NIM Response Main Frame I I SV includes U S Power Cord and User s Guide 82 50001 NIM Response Patient Interface 82 50200 NIM Muting DEM A 82 20300 Prass Flush tip Monopolar Stimulator Probes 1 box of 5 82 25101 NIM Response Patient Simulator 82 50600 Box 5 sets Paired Subdermal Electrodes 82 27410 Printer and Accessories optional venena 82 50110 OPERATING ROOM SETUP LOCATION FRONT PANEL DISPLAY SPEAKER Set the NIM Response on a table or cart located about 10 feet from the surgical field but as far as possible from the electrosurgical unit Also consider traffic patterns and sterile areas The surgeon may have further preferences as to location and visibility Clip the PATIENT INTERFACE box to the surgical bed near the head of the patient and within reach of the sterile electrode leads and sterile stimula
56. l features a screen which displays EMG waveforms The NIM Response is operated by using touch sensitive areas of the display screen MONITORING SCREEN O OOMAIStimulus 0 measures The MONITORING SCREEN displays EMG waveforms A STIMULUS FILTER indicates where the STIMULUS FILTER ends and real EMG data begins when using either a monopolar or bipolar stimulator connected to the NIM Response The touch sensitive areas of the screen provide informa tion and control toggling between settings or displaving popup menus Fvent Threshold CHANNELS 1 4 Four channels can be monitored During power up the NIM RESPONSE automatically turns ON each channel that has an electrode connected from the patient to the Patient Interface Pressing the CHANNEL button toggles the corresponding channel ON or OFF TIME SCALE INDICATOR AND CONTROL 15 36 0 0 00 mA E 186169005 0 00 m4 Measured The 50 mS TIME SCALE is the Power Up default The 50 mS TIME SCALE graphs a detailed view of the data and is most effectively used to view a captured event or the detail for baseline or non stimulated activity When EVENT CAPTURE is ON the screen wil display the detail of the last event captured until a new event occurs When EVENT CAPTURE is OFF the screen displays a slightly undulating line unti an event over the threshold level occurs then that event appear
57. l pouches intended for single use only Patent No 4 892 105 2 25110 Standard Prass Probe Tip Dispenser 82 25105 Slim Prass Probe Tip Dispenser 10 Box 82 25251 Yingling Monapolar Stimulating Probe Package Protected 5 Box Tip and Handle packaged sterile in individual pouches pended for single usc only 82 25051 Monopolar Stimulator Handles Dispenser Bax Protected esee 10 Box 82 25351 Kartush Concentrie Bipolar Stimulator Package Protected Pin 5 Box Probe and Cable packaged sterile in individual pouches Intended for single use only 82 2540 Kartush Side by Side Bipolar Stimulator Package Protected Pin mo 5 Box Probe and Cable packaged sterile in individual pouches Intended for single use only 82 25296 Bipolar Stimulator Cable Tor use with Bipolar Probe Protected 10 Box Stimulators are used with 82 25350 82 25355 82 25400 and 82 25405 Probes PRASS PAIRED EMG ELECTRODES Paired 27 g needles 5 mm inter electrode distance insulated to 5 mm of tip Twisted pair Im cable with 2 mm pin connectors One pair red one pair blue with two gre
58. ntronics Parallel 36 pin female 260 V RMS 60 Hz lt mA AHTO Connections to Chassis Ground VGA Compatible 640 x 480 resolution 15 pin D sub Male 264 V RMS 60 Hz lt I mA ALL Connections to Chassis Ground 100V 120V 220V and 230 240V 10 50 60 5 63 W Nominal 250 VA 4000 V Peak to Peak 60 Hz dielectric withstand from Line Connectians to Signal Ground All patient probes and electrodes are Type BF Applied Parts Class 1 Medical Device per IEC EN 60601 1 NOTE Medtronic Xomed reserves the right to change specifications and or designs without notice All Specifications are lt 10 unless nored A Proprietary Technology Feature of Xomed 37 38 5 APPENDIX E AGENCY APPROVALS SAFETY The Nerve Integrity Monitor Response System was tested to and complies with IEC EN 60601 1 Medical electrical equipment Part 1 2 Collateral standard for electromagnetic compatibility UL2601 1 CSA 22 2 No 601 AS3200 EMC DIRECTIVE CLASSIFICATION AND USE The equipment complies with the EC Electromagnetic Compatibility Directive EMCD 89 336 EEC as amended by 93 68 EEC subject to the following declaration It is intended for use in surgical operating theaters for patient connected intraoperative nerve monitoring during surgery i EMISSIONS SUSCEPTIBILITY NIM Response system complies with IEC EN 60601 1 2 CISPR 22 LEVEL A CLASSIFICATION The NIM Response System is a Class
59. operating range or OFF MUTING ALERT When the NIM Response stays in Mute mode for more than 60 S except during an ELECTRODES CHECK the MUTING alarm sounds to warn that there is no ongoing acoustic or visual monitor ing The message WARNING MONITORING IS DISABLED flashes on the screen Alarms repeat every 60 S until the NIM Response exits Mute mode ADJUSTING THE EVENT THRESHOLD 20 BASELINE ACTIVITY Typically when the nerve to be monitored is not being electrically stimulated or manipulated by the surgeon there is little or no EMG activity detected Therefore the magnitude of the on going quiet baseline signals may be quite small These signals may be 30 pV or less and are shown on the Jeft side of the screen near the appropriate channel microvolts u V only when Event Capture is Off If Event Capture is On microvolts u V will reflect the amplitude of the last event on the channel s being monitored Peak to Peak Voltage Reading SETTING THE STIMULUS LEVEL Press the STIMULUS setting button in the upper left corner to adjust the stimulus output to the desired level The stimulation level is displayed on the button Stimulus Control and Indicator At present there is no complete agreement on the optimal level for facial nerve stimulation Beck and Benecke 1990 The absolnte stimulus intensity required to adequately stimulate any cranial motor nerve is determined by a complex combination of se
60. or decreasing baseline announcing BASELINE INCREASED for each significant further increase Ifthe baseline value decreases die auto EVENT THRESHOLD resets at a lower value until the setting reaches manual setting ofthe EVENT THRESHOLD At that time Baseline Decreased is announced the text auto stops flashing MEASUREMENT CURSOR 1 06 36 With Event Capture on touching a point of a wave form causes a pop up box to appear the screen The voltage amplitude and time from zero known as latency are displayed CALIBRATING THE TOUCH SCREEN When the touch screen seems to respond in an unexpected manner it may be necessary to calibrate the Touch Screen This happens because the Touch Toots Screen registers the press in the wrong place on the screen Examples ofthis are 1 the Touch Screen failing to respond or responding erratically To calibrate the Touch screen turn the power of the NIM Response OFF and back ON again When the Xomed NIM Response Splash Screen appears press the Touch Screen until prompted to remove your finger press Touch Screen Calibration Next a prompt is displayed to touch the lower left corner and the upper right corner of the screen Finally a prompt is displayed to touch the center of a circle appearing in the upper right corner of the screen f the touch is not registered in the center of the circle the sequence must be repeated When the Touch screen completes the cal
61. pment such as bipolar electro cautery ultrasonic debulking devices or other external devices which generate interfering signals Always attach the MUTING PROBE close to the output jacks of the electrosurgical or other unit rather than near the handpiece the surgeon uses More than one output cable may be accommo dated in the MUTING PROBE at one time To install the MUTING PROBE I Open the MUTING PROBE jaws and insert the cable from the external device s Slide the cable so the probe is near the main unit of the external device s not near the handpiece s 3 Slip the upper side of the anti slide ring around the end of the MUTING PROBE to form a U around the cable Pull it snugly against the probe s lower jaws 19 MUTING PROBE INPUTS There are four input jacks for MUTING PROBE input These four input jacks are individually preset to represent a graduated muting gain Input jack 1 is the least sensitive for muting detection while input jack 4 is the most sensitive MUTING PROBE jack 3 provides the typical gain value for the muting detection feature Should there be a need for more or less gain depending upon the conditions of the operating room setting or amount of detection desired from a given electrosurgical unit simply move the muting probe into a more appropriate jack WARNING AUDITORY AND VISUAL MONITORING ARE DISABLED WHILE MUTING IS IN EFFECT SOFTWARE SETUP The NIM Response front pane
62. roper data acguisition None of the audible alarms should be ignored One must assume that valid monitoring has been halted and determine immediately why the alarm sounded There are three distinct alarms BEEP ALARM The high pitched repetitive beep is used to register failure of internal microprocessor hardware When you hear it at any time other than at Power Up stop using the NIM Response System and contact MEDTRONIC XOMED Customer Service at 1 800 874 5797 BLEEDLE ALARM This is a three note alarm BLEE dle DEET that cannot be disabled it repeats until the responsible condition is remedied This alarm is heard when A recording clectrode lead is off repeats every 20 Seconds The NIM Response System has been in MUTE mode for more than one minute unless you are in ELECTRODE CHECK Repeats about once per minute VOICE ALARM Several context specific voice alarms are available A relevant message is simultaneously dis played WHEN THE CASE IS COMPLETE Before closing the surgical site the surgeon should evaluate the nerve s functional integrity one more time This should be done by stimulating the nerve both proximal and distal to the immediate dissection area as far as 15 accessible within the surgical field Use the lowest level of stimulation that produces a response f Continue to monitor with the NIM Response System throughout the procedure until the incision is closed since items such as wound dressings might exert
63. rresponding cranial nerve number Monitoring continues in the background while these menus are displayed Press the Cranial Nerve number and electrodes appear The exact placement of electrodes is based on the physician s knowledge of the procedure and the Crania Nerves that are to be monitored during the procedure Red Wiro Right Voca Fold Red Wire Polr Cn2 Right Voco Fold PRINT SAVE PRINT sends the screen displayed to the printer TOOLS TOOLS button allows access to advanced features of the NIM Response CUSTOMIZE MENU CUSTOMIZE provides menus used to configure many of the NIM RESPONSE features QUICK SETUP MENU QUICK SETUP menu provides the ability to create and select surgeon or proce dure preferences for feature controls and settings Afer selecting QUICK HELP pressing any feature on the Main Monitoring Screen displays an explanation of that feature od TIME SCALE TIME SCALE toggles between two different display time scales 50 mS and 10 S Selection is displayed on the right middle portion of the screen in the main menu 10 VERTICAL SCALE EVENT CAPTURE VERTICAL SCALE selects the range of the EMG data display from 200 500 or 2000 scale Selection is displayed on the right middle portion of the screen in the main menu Changing the VERTICAL SCALE only affects the way the data is presented on the screen It does not modify the sensitivity of th
64. s only briefly on the display do The 108 TIME SCALE which resembles a histogram graphs the maximum amplitude excursion of the 50 mS TIME SCALE sample not just events above the EVENT THRESHOLD setting That is each vertical bar one pixel column in the 10 S TIME SCALE represents a sample which can be expanded in 50 mS TIME SCALE The 10S TIME SCALE is useful for visualizing recent baseline EMG levels of active channels and the STIM Marker to show Stimulus activity When EVENT CAPTURE is ON and an event over the threshold setting occurs the Tone audio if selected will sound The NIM Response continues to take readings and display the ongoing data in the 10 S TIME SCALE EVENT THRESHOLD Any EMG activity that exceeds the EVENT THRESHOLD is defined as an event The event is heard as called an EVENT TONE When EVENT CAPTURE is ON these event waveforms are displayed until replaced by next event The EVENT THRESHOLD is adjustable from 20 LIV to 2500 uV The default EVENT THRESHOLD is 100 uV Under certain circumstances the default value of 100 uV may not be significantly greater than the baseline activity therefore it may be too sensitive Inthis case the EVENT THRESHOLD may be adjusted to reflect a more appropriate setting To adjust the EVENT THRESHOLD setting press the button indicating the present setting The setting will flash The setting can then be adjusted by either touching the grap
65. s of use and the Bleedle alarin repeats every 30 Seconds thereafter 13 STIMULUS VOICES STIMULUS VOICES can be configured as SETTING STIMULUS TONE or OFF The default is STIMULUS VOICE set to ON and SETTING selected Stimulus Voice The stimulus voice verifies delivery of current to the surgical field Setting Voice The SETTING VOICE announces the value ofthe STIMULUS it also announces the new stimulus setting when it is adjusted Example 0 50 mA is announced as Point Five Tone DEFAULTS Stimulus delivered through the probe to the surgical field is confirmed by a tone Setting A Default Other Options Help Voices cerent onec Check Electrode Stimulus Voices Setting Stimulus Tone Tones Submenu 14 EMG AUDIO EVENT TONES CCALIRLOUS 7 The TONES submenu controls the raw audio and tones produced by the NIM Response The EMG Audio and EMG Tones cannot be turned OFF simulta neously The EMG Audio can be turned ON or OFF When it is ON EMG activity can be heard as a static like grinding sound The volume can be turned up or down STIMULUS using the Volume Control keys When it is OFF the EMG audio cannot be heard The default setting is EMG audio on The Event Tones can be turned ON or OFF When itis ON event el Vor above the set EVENT THRESHOLD is heard beep tone The tone reflects Kai
66. tified Identify source of interference then eliminate or separate the NIM Response system NIM Response system or Patient Interface Maintain separation between electrosurgical cable and the i 1 cable too close to ESU ar cables NIM Response system For less coupling coil up the Muting Probe next ta the i NIM Response system ea X Interference on anesthesia Lead checking current near anesthesia Anesthesia try alternate electrode channel equipment electrodes Tum stinmlatar to 0 0mA when not stimulating nm OTT TA M Unit receiving excessive signal into the Mave the Muting Probe connector to a lower number unit Muting Probe or electrode leads unti it stops muting stii mutes in position 1 7 disconnect the muting detector completely Excessive muting i 24 RY Inadequate muting No response to direct stimulation nerve e ent ce M Unexpected responses when not directly stimulating Signal from ESU is inadequate to cause muting Inadequate stimulus intensity Paralyzing anesthetic in usc White stimulation electrode has fallen oul is not connected Probe not connected Patient safety fuse blown Not holding probe on nerve lang enough Nerve not contacted Volume control too low Event threshold set too high No
67. tor cable 5 Keep the PATIENT INTERFACE cable and electrodes away from other operating room cords When wires must cross they should cross at right angles Never run operating room cords parallel to any ofthe NIM Response wires Lay the PATIENT INTERFACE cable out of busy traffic patterns and secure it to the floor as needed Attach the MUTING PROBE to the electrosurgical unit and plug it into one ofthe MUTING PROBE INPUT jacks on the rear panel ofthe NIM Response Each MUTING PROBE has cable which may be taped to the floor Bfiniolos Front Panel of the NIM Response Monitor The touch screen displays both EMG waveforms and controls many functions of the monitor The complete description of these controls are in the Software Setup section The SPEAKER provides audio alarms and acoustic EMG monitoring sage t REAR PANEL eres ii 1 ry 1 9 j Pd 4 E cd i Ery NIM Response Rear Panel 1 LPT OUTPUT The LPT I OUTPUT is a centronix type connector for a PRINTER LS120 or Zip Drive 2 VGA OUTPUT A VGA OUTPUT is available through the standard VGA 15 pin connector on the back panel The NIM Response can be connected directly to a VGA monitor The VGA output can also be con verted to S VIDEO format for use with S VIDEO VCR the LandmarX Image Guided Surgery System or other S VIDEO devices FOOTSWITCH
68. ts Otolaryngology Head amp Neck Surgery 1990 102 270 272 Kartush J Electroneurography and Intraoperative Facial Monitoring in Contemporary Neurotology Otolaryngology Head amp Neck Surgery 1989 101 496 503 Kartush J and Bouchard K eds Veuromonitoring in Otology and Head and Neck Surgery New York Raven Press 1992 i M ller A R Evoked Potentials in Intraoperative Monitoring Baltimore Williams amp Wilkins 1988 Shallop J Sev enth and Eighth Nerve Monitoring During Acoustic Tumor Surgery Seminars in Hearing 1989 10 346 355 39 M P a 7 ai wa a 1 9 313 5 5 353 ALATA A Medtronic Xomed Surgical Products Inc 6743 Southpoint Drive North Jacksonville Florida 32216 0908 U S A 68E3247 B 03 00 REF 82 50003 5 e amp ATTACHMENTB MDC WODOC WORK ORDER _ 03 31 00 07 04 PAGE 1 ome Part 8250001 Desc NIM RESPONSE MAINFRAME 115V 1 EA Order Lot 19727500 Line 0001 Order Qty 3 0000 EE 7 3 103140 7 21 7 215246707197275007 s0p16 67h9 5v0s0b4099T 0001 Due Date 04 22 00 Spec Date 02 15 00 Start Date 04 12 00 MFG Code 300 Non Conformance Report NCR LU 4836 Sterile Load 4 YSGO DATE OPERATORS GOOD SCRAP JOB ALT LABOR WORK OTY OTY STEP OPER FUNCT COST CTR CENTER 5 7 TO 3 10 0001 206 06A SU M L RT M
69. urrent Measured in ohms intensity Strength of either a stimuli or response medial i More toward the middle relative toa fixed point monophasic waveform A waveform which has components that lie only on one side of the original baseline An electrical artifact is typical of this type of response pattern monopolar stimulation Wide spread cathode to anode relationship stimulation where the stimulator serves as one pole of the current flow and a distant subdermal needle electrode serves as the other pole Recommended for mapping strategy in locating neural tissue motor nerve Nerve which terminates in a muscle or muscle group and when stimulated causes muscle contrac tion relaxation obicularis oculi muscle Large circular muscle group surrounding the orbit of the eye obicularis oris muscle Large circular muscle group surrounding the mouth ohm 2 Unit of measure for resistance One ohm is the amount of resistance in a circuit having a potential difference of one volt and a current of one ampere 1KQ 1000 ohms Ohm 5 Law A law of electrical physics deseribing the relationship between voltage resistance and current delivered through an element circuit where the delivered current 1 is egual to voltage E divided by resistance R oscilloscope An instrament or part of an instrument used for viewing waveforms or other electrical information The display usually represents frequency and amplitude c
70. veral factors including but not limited to the following The functional health of the nerve itself The type of stimulation probe used monopolar or bipolar How well the stimulator probe makes contact with the nerve Whether cerebral spinal fluid is covering the nerve etc The duration of the stimulus You may want to use the smallest amount of stimulus necessary to elicit a detectable EMG event Typically stimulus current levels of 0 3 mA are high enough for adequate direct monopolar stimulation of the facial nerve The best guideline for setting the stimulus intensity level is to use the lowest amount of stimulation that produces an EMG response large enough for monitoring WHEN ELECTROCAUTERY AND CUSA ARE USED When the electrocautery is in use the NIM Response mutes After 60 seconds of muting due to electrocautery you hear MUTING and WARNING MONITORING IS DISABLED is displayed The bicedle alarm sounds every 60 seconds Whenever electrocautery is in use or is in the standby mode the electrocautery tip should be isolated from the NIM Response stimulator probe and electrodes When CUSA cavitron ic ultrasonic aspirator is in use effective monitoring cannot take place The baseline may rise on one or both channels to 200 500 u V You may compensate by adjusting the Event Threshold up and then down after the CUSA is off The baseline may still linger at 40 80 uV However an increase in the baseline right after use
71. ype Order Qty Open Date Start Date 024 20490600 0001 STK 5 0000 08 21 00 09 27 00 Due Date 10 01 00 Details 025 20490700 0001 STK 5 0000 08 21 00 10 19 00 Due Date 10 23 00 Details 026 20655100 0001 STK 5 0000 09 14 00 10 19 00 Due Date 10 23 00 Details 027 20655200 0001 STK 5 0000 09 14 00 10 19 00 Due Date 10 23 00 Details lt 028 20732600 0001 STK 5 0000 09 29 00 10 19 00 Due Date 10 23 00 Details lt i 029 20732700 0001 STK 5 0000 09 29 00 11 01 00 Due Date 11 05 00 Details lt 030 21008300 0001 STK 5 0000 11 17 00 11 17 00 Due Date 12 30 00 Details lt 031 21096600 0001 STK 5 0000 12 04 00 12 04 00 Due Date 12 30 00 Details lt 032 21115900 0001 STK 1 0000 12 05 00 12 29 00 Due Date 01 08 01 Details lt 033 21133300 0001 STK 15 0000 12 07 00 12 07 00 Due Date 01 15 01 Details 034 21180300 0001 STK 1 0000 12 12 00 01 06 01 Due Date 01 15 01 Details 035 21245800 0001 STK 3 0000 12 22 00 12 22 00 Due Date 01 05 01 Details 036 21249500 0001 STK 4 0000 12 27 00 01 11 01 Due Date 01 20 01 Details 037 21254600 0001 STK 3 0000 12 27 00 12 27 00 Due Date 01 10 01 Details Data collected from the Medtronic Xomed CHESS ERP System on March 18 2010 jaxm1bnas02 home01 heshes1 DOCS WORD Docs WO HISTORY 8250001 doc Page 2 of 2

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