Service Manual
Contents
1. 11 Preventive and Corrective Maintenance 11 Advanced System Check 12 Cleaning and Maintenance 12 Cleaning after gach use nescis en EON n DR Rain 12 QC 12 IV FAVA YIN SNNT u ia RN 12 ip PR 13 Console Puse Replacement i Lulu laaiakuawawayauqhaqiywwkwalawsquqqas 13 Patient Interface Fuse Replacement 14 Tronbleshegtik uuu y ls Os eral qasaqa 15 Technical Specifications 17 Block Diri i um ee M RE USE DM 19 Service Manual Symbols Defi n it i ons used in this manual APS Automatic Periodic Stimulation NIM Nerve Integrity Monitor NIM 3 0 NIM Neuro 3 0 or the NIM Response 3 0 A sequence is defined as a series of events separated from each other by less than one Event Sequence second Stimulus Rejection Adjustable delay reading EMG after stimulation Period In previous versions of the NIM this was referred to as Stimulus Artifact or Artifact Delay GUI Graphic User Interface DSP Digital Signal Processor ABR Auditory Brainstem Response SSEP Somatosensory Symbols Do not dispose of this product in the unsorted municipal waste stream Dispose of this product according to local regulations See http recycling Medtronic Com for instructions on prope2. 3 0 system or Patient Interface cable too Maintain separation between electrosurgical cable and close to electrosurgical unit or its cables the NIM system For less coupling coil up the Muting Detector Probe next to the NIM 3 0 s Disconnect the muting detector completely E AKIE Vj gq O e 3 cj o 3 Q AEEA OI O o E ee C Z 2g E S glo Qu O WN e un O O 5 ZO e O e cof O Excessive Muting Unit receiving excessive signal into the Muting Detector Probe or electrode leads Pacemakers Pace Pulse Relocate electrode ground and stimulus return to patients shoulder Acromion Signal from electrosurgical unit inadequate to Loop the electrosurgical unit cable and clip the muting ing detector over the doubled cable N er O Q e DN O B e Increase stimulus intensity Eliminate paralyzing anesthetic Check that Stimulus Measure is approximately the same value as the Stimulus setting Re insert electrode in nadequate stimulus intensity aralyzing anesthetic in use No response to direct stimulation question robe electrode not connected Check stimulator anode and cathode connections Patient safety fuse blown Check fuse in STIM 1 EMG Patient Interface Replace if STIM 1 EMG Patient Interface fuse REF necessary 8253075 ro to Jim a e 4 BE ZEB o E ag 5 o O C cor m Cu O
3. 5 ND e o 5 en co enough Hold probe tip to nerve for at least 1 second Check stimulator tip for obstruction Replace if necessary Check location of stimulation Check and correct all settings volume event threshold gh stimulus intensity xcessive current shunting in surgical field Remove fluids from surgical stimulating area tri lt Q J cr cof gt c DN D Qu o e er co za lt ZIZ o o m S cs o og al2 oP o BR ES o 9 alo JB z v lt O o 2 Z oo ne EB dm co e Q eg 5 5 5 O m lt 5 er O Qi c DN e O DN DN c O Z O mr lt O Fd 5 O O O 5 5 OQ c oO a or m e O DN 5 DN Oo O et O 5 m O O Check EMG tube placement if applicable E Service Manual 5 Troubleshooting Unexpected responses when not Unexplained continuous train EMG response Identify and eliminate possible source of train directly stimulating nerve stimulation Cold irrigation Laser heat Retraction on nerve or muscles being recorded Patient waking from anesthesia Nerve drying Ultrasonic aspirator Nerve or monitoring area being stimulated or Identify and eliminate source of inadvertent manipulated by thermal or mechanical means manipulation Metal to metal discharge artifact Determine response type from waveform pattern on 50
4. H x 256 W Dedicated Function Event Touch Screen Controls For Amplitude Time Display and Capture Vertical Display 20 100 500 1000 2000 10 000 50 K and 100 KuV display modes Event Capture Enable disable capture mode indicator on touch screen Time Scale 25 mS 50 mS 100 mS or 20 S display modes Stimulator 1 and 2 Stimulus Type Constant Constant Current Stimulus Range 0 30 mA a minimum of 80 V compliance 80 volts 80 V 10 tested into a 10 K load Load Impedance Range As long as the load impedance X 100 10 KOhms 0 3 mA Compliance 10 V 3 5 30 mA Compliance 60 V stimulation current is less or equal the compliance voltage Stimulus Control Digitally controlled range dependent adjustment increments of 0 01 0 05 0 1 5 and 1 0 mA Stimulus Output Accuracy 01 mA or 10 of reading at 1K load over Stimulus Range Stimulus Adjustment Graduated Touch Screen Control with display of command current and delivered current Stimulus Measurement Accuracy 02 mA or 10 of reading at 1K load over Stimulus Range Internal Fuse 32 mA Type E 250 V 5 x 20 mm It must be Xomed 8253075 other similar fuses may not give the same degree of protection Order 8253075 Fuse Kit for replacements Stimulus 1 and 2 Characteristics Waveform Monophasic square pulse no DC component Duration Software selectable 50 100 150 200 or 250 us 10 of setting Rise Time to 30 mA Less than 10 us Rate STIM 1 and 2 Softwar
5. Q EENS 5 Customer CARE ero ia EO Ee uS OD COR ernie 6 Medtronic Xomed ING deuceeeuennies estesecoccepieseteni e cexs tuc ereces seo edacud 6 Iss Pi EC C 6 International Service 6 FGA INC iOi o ose opone 1E NMPYEUPNEREESI SEPA ENS CO PURI CUR FUR VENKE 6 C OBIDOBORISu T 6 Front Paneler ra edes mhi seuals e E spa D EPA 6 P Tu EE uuu TT 6 Rear Panel uuu uuu aaaaaswassawaaaaywakasaqawaqsawsassaqaahaska asassqaqsasqhikas 6 NIM 3 0 Patient Interface 7 Stimulator Probes and Handlss 7 KONOP 27 PM E E E 7 SiG a u sec E EE NE 7 Patient Interface and Simulator 7 UMTS OMe lir yoe E E E 8 Annual System Quick Check 8 Power Up DIAC MOSES uama haqa ananassa aqu sima kpmaayaqsaqqi 8 Contirmins P IGCLFORSS oem aaae 9 Electrode Lead Nomad u MEE LIE 9 Slimulatiom Go octossoo cde dota rin die etd ear P Resin kin SEbE Pe et EILSE ANANE se Dr paRR RUE DUE 9 Mechanical Stimulation 9 Set and Med tre uuu nas aaa ee eser dE 10 Threshold Eas Ks ene nee Pn ERES SPEM DE ERU MEL npani 10 Simulation Troubleshooting 10 Annual System Quick Check Data Sheet
6. replace electrode for appropriate channel 2KQ Subdermal electrodes or with highest impedance reading first 10KQ Prass Paired electrodes Mismatched pair Remove and replace electrode in question Unequal placement Measuring current on NIM EMG Electrodes lectrode pin disconnected from patient interface gi E e EXIT Jes O Biel aie a E e R E a o f 9 8 APIS Als M O10 P a o b oyes Eg lo a O o 5 5 O a 2 O cg oO s gt a v Interference on anesthesia equipment EKG Monitor Try an alternate EKG Lead set Deselect Electrode Screen See Excessive Muting Symptom Column Turn the NIM Stimulator to 0 0 mA when not needed Incrementing Probe will not adjust Loose connector Check connector is properly aligned and fully seated See stimulation System Set Up Patient Interface Set Up Stimulus keeps changing run away Bad Incrementing Probe Replace Incrementing Probe or disconnect STIM CONTROL connector and manually adjust stimulus at touch screen Electrosurgical interference Muting Detector Probe not connected Check Muting Detector Probe connections Muting Detector Probe input insufficient Loop the unit cable through muting detector Electrosurgical grounding inadequate Check electrosurgical grounding pad on g pad ce of interference unidentified Identify source of interference then eliminate or separate from the NIM 3 0 system Sour NIM
7. switch turns the power ON or OFF Power Connector The power cord plugs into the back of the NIM 3 0 System console The input fuses and accessory output is in the power entry module Plug the power cord into the A C power outlet Equipotential Uniform potential For future use USB Out Ihe USB Out is an industry standard USB type connector two port that can be used with mass storage devices printer keyboard H VGA Output Used only to connect NIM Neuro 3 0 System to microscope Not active on NIM Response 3 0 System L Surgeon Mini Screen Port Output connection to Surgeon Mini Screen or ad Muting Detector Input Near field radio frequency detector Patient Interface Connector The patient interface connector is a 25 pin D sub Handswitch APS only Jaw Cy mh A Service Manual M RCR Audio Jack An RCA audio jack is provided to output an audio signal that can be overlaid onto a video signal when using industry standard recording devices The output will be audio line level 1 Vp p N Mini Jack Standard configuration is for private listening through Stereo Headphones O Carry Handle for transporting unit P Anti Glare Stand This device is used to change the viewing angle of the NIM screen it is shown in the tilted up position NIM 3 0 Patient Interface The NIM 3 0 Patient Interface and cable are the link between the NIM 3 0 and the Patient The patient interface has eight four or two depend
8. unintentional manipulation The system records electromyographic EMG activity from muscles innervated by the affected nerve If you are experiencing problems with the NIM 3 0 System we recommend returning the unit to Medtronic Xomed for repair and integrity testing Some of the diagnostic testing can be performed by the Biomedical Technician using general lab equipment and the components provided in this package Note Biomedical technician s performing the verification Test Procedure shall be fully familiar with functions operations warnings and components of the entire system Components Front Panel S Medtronic STIM 1 stimulus adjustment STIM 2 stimulus adjustment Volume adjustment he Speaker provides audio alarms acoustic EMG monitoring and voice prompts Product name Touchscreen The Touch Screen displays EMG waveforms and controls many of the functions of the NIM a eee Side Panel A USB Out The USB Out is an industry standard USB type connector that can be used with mass storage devices B Anti Glare Stand This device is used to change the viewing angle of the NIM 3 0 screen It is shown in the tilted up position Rear Panel e eum UI A Accessory Power Outlet The Accessory Power Outlet used with the approved NIM 3 0 Accessories i e the approved printer power supply only Fuse Access The AC power fuses are located on the back of the units Power Switch The power
9. I eu6iq ze edit d SAB291014 Ui sued PIBS TASN Z uns eqoig InW ped paddy O I reubiQ yoywspueH Jg ed s lioss 5 5v euoudpeaH WHS 19uldu y otpny moss O I eui ed perjdc amy em x OWS uoljejnsul 93iseg inso 5u3 0 sIlnd NWIN pue o g suods uz IIN 0 oin N NIN 104 weeg y5olg Block Diagram Service Manual id EC REP Medtronic Medtronic Xomed Inc 6743 Southpoint Drive North Jacksonville FL 32216 USA www medtronicENT com www medtronicENT TechComms com Medtronic B V Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel 011 31 45 566 8000 Fax 011 31 45 566 8668 0123 O 2009 Medtronic Inc All rights reserved Printed in the USA 09 2009 REF 8253062 68E4086 A
10. M 3 0 Universal Patient Simulator there are 8 channel stimulation contact pads one 1 for each channel These contacts are the points for activating individual circuits A monopolar probe is recommended for use during testing Patient Interface and Simulator Simulator use requires prior setup of the NIM 3 0 unit see User s Guide if needed Positive electrode jacks Patient Interface Cable Adapter 11685633 Negative electrode jacks Patient Interface Cable Adapter 11685633 Stimulator STIM 1 jack Incrementing Probe control jack Stimulus return jack Electrode ground Patient Interface Cable Adapter 11685633 Auxiliary stimulator STIM 2 or APS jack Note APS Stimulating Electrode cannot be used with the Simulator Om MOO E gt NIM 3 0 E HHEM Simulated positive electrodes for connection to the Patient Interface Simulated negative electrodes for connection to the Patient Interface Simulated electrode ground plug for connection to the Patient Interface Simulated stimulus return plug for connection to the Patient Interface Simulated patient with inserted electrodes pads D m UA W M Monopolor Probe for stimulating patient electrode pads Simulated Events N Stimulus plugs for connection to the Patient Interface Annual System Quick Check O Toggle button control plug for connection to the Patient Interface An nua Syst em Q u i ck C A e ck P NIM Response 3 0 Patient Interfa
11. capacity Xomed Part 11270068 Order 8253075 Fuse Kit for replacements All patient probes and electrodes are Type BF applied parts 90 264 Vrms 50 60 Hz lt 100uA Mains on applied part N C 100 pF 30 1 kHz All patient probes and electrodes combined to Safety GND Class I Medical Device per IEC60601 1 1988 A1 1992 A2 1995 A 13 1995 Type BF applied parts IPXI Not suitable for use in the presence of flammable anesthetic mixtures Service Manual Block Diagram 19 600c SC 8 V et Puuna uonezi enb3 AAAAAAAARnR je1 U9 0d yeg 9A1 2930Jd YUM Sed pi uS IeJ IN yeg LX 9A29 0Jd A N A ddns 1 mod Jo Auepuooes pue S n3115 eIp uui ul Asewiid y u mz q p u iez AJ9A1 591o1d UO E NSUI p92340JUl9M sosnj Yd IMS Q O O Q uonnquisiq jepuooeg al NU lu6ipioeg oe PONE p109 lqix qd O O O O a d e dsi PIO lasiq C JOMOd Aseyixny I UsaJOS YONO jejnduio E preogefpus eas B sng Snid v0L Od t O I H dsa joued Je8y I casn vasn ued paddy Peu me osngsn P E Eun ueaJosiul A 0 Indi nOo Ajuo oin N ple O9pIA INGINC o9plA eq paddy O
12. ces is shown for reference only connections are the same Incrementing Probe Stimulus Adjustment Power U p Diagnostics The single use Incrementing Probe provides the surgeon with the 1 Turn console power On means to adjust the stimulation current at the surgical site 2 Verify alert beeping sounds for approximately 5 seconds at power Note If the incrementing probe handle malfunctions immediately up disconnect the Toggle Button Control Plug from the Incrementing Probe Mn Ere ir the Patient Wii and use console k eee eee eee B1 Toggle button normal or at rest NIM Response 3 0 B2 Increase current B3 Decrease current B4 Press and hold saves current screen to memory for Reports and to selected peripheral device Printer and or USB flash drive Si m u ato r Set u p Copyright 2009 Medtronic Inc All Rights Reserved 1 Connect all channel jumper cables simulated subdermal electrodes ground and STIM 1 return STIM 1 return can also be used as the STIM 2 return from the simulator to the corresponding patient 3 AtSplash screen an internal integrity check is automatically interface See Wiring Table performed each time the system is turned On You see a series of messages on the display screen The integrity consist of Wiring Table NIM NIM Patient Simulator to Patient ba di Neuro 3 0 Interface ein w t e e v
13. committed to provide the highest standard of workmanship in manufacturing its products Your NIM 3 0 System requires minimal maintenance and calibration However Medtronic Xomed recommends preventative maintenance and screen calibration scheduled at yearly intervals ee eee eee Compaen cm and calibration should be performed by returning the entire system including the patient interface and Muting Detector to Medtronic Xomed Customer Care Contact them directly for details of how to return your product Patient Interface Ground Cable P N 11249170 1 Each kilo ohms Resistor Cable Assembly P N 11681740 1Each RESISTOR 10K m e 10 kilo ohms Resistor Cable Assembly P N 11681741 1Each 22 kilo ohms Resistor Cable Assembly P N 11681742 1Each The following items are not provided with the Biomedical Test Kit but are required to perform the test e NIM 3 0 System and system components e NIM 3 0 Printer Optional e USB Keyboard 12 Service Manual Fuses Fuses Console Fuse Replacement The console i le AC power is fuse protected Have a Biomedical Engineer d It is very important that the ime lag O check the fuse if a problem is suspected It i correct replacement fuse is used 5 x 20 mm 2 5 Amp time lag Low breaking capacity Xomed Fuse Kit 8253070 Fuses Patient Interface Fuse Replacement The Patient Interface has its own fuse It is very important that the correct fuse is u
14. ction against electrical shock Degree of protection against electrical shock Incress of water dust or solids IEC 60529 Use with flammable anesthetics mixtures with air oxygen and nitrous oxide 18 102 4 dB SPL C Weighted 30 5 cm Continuously processed EMG and or activity level dependent event tones for each channel Volume Power Up Pre set Default and a Low Volume Limiter Volume Presets for Main Tones Voices and EMG Volumes Signal occurs when 80 of set current is measured over range of 0 05 30 mA Constant Power up Decaying Power down Tone Selectable ON OFF RCA Phone Jack Impedance 1KHz is 25 Q or greater SPL 107 4 dB Plug 3 5 mm Stereo Nickel Plated 60 to 83 dB 6 dB SPL C Weighted Radio Shack Headphones P N 33 1223 Sennheiser P N HD497 Radio Shack Volume Amplifier P N 33 1109 Radio Shack Radio Shack 16 Shielded Audio cable P N 42 2493 Radio Shack Hewlett Packard DeskJet PCL5 compatible USB 2 Hewlett Packard Model HP DeskJet 6840 printer NIM Printer Medical Grade Power Supply Medtronic 8253025 SanDisk Brand Cruzer Mini SanDisk Brand Cruzer Micro XVGA Compatible 1024 x 768 resolution 15 pin HD 100 V 120 V 50 60 Hz 62 W Nominal lt 78 W Peak Total 33 W Console 10 W Printer and 19 W Mini Screen NIM Printer Power Supply 150 VA Max 4000 V Peak to Peak 60Hz dielectric withstand from Line Connections to Signal Ground 5 x 20 mm 2 5 Amp 250V Time llag Low breaking
15. d Audio files EFIGS as selected by user Please Wait 4 At Program Loading indicator verify audible three tone alarm Bleed dle deet hereafter refer to as Bleedle alarm tone Service Manual Setup Step 1 of 2 E Information 1 Select Procedure Neuro Otology Head Neck Peripheral Custom Procedures indicates default settings have been changed Global Help Settings GUI VXXXX X XXXXX DSP vxxXx X xX xxxx 5 1 2009 9 00 AM 5 The next screen to open will be Set up Select Procedure Step 1 of 2 unless a problem was found with the system during the internal integrity check In which case the NIM 3 0 stopped the internal integrity check at the failure No monitoring shall take place 6 If Set up Step 1 of 2 opened check off System Set up in the Annual System Quick Check Data Sheet 7 Optional Operator may enter change Date Time Language or Data Fields via Global Setting button 8 Select Procedure Set up Select Procedure Step 1 of 2 is the default screen requiring the operator to select an existing procedure or begin a new custom procedure Any procedure using all channels may be used For this procedure we will assume that the operator has setup a Custom Procedure see System Set up Custom Set up in the Users Guide for instructions called Simulation Test and named the channels Ch 1 Ch 2 ete Confirming Electrodes This check confirms that all electrode circuits are conn
16. e se Bus Bue i Este ox mc idco eerta spen Red Red 2 Positive x X Red Blak 2 Negative x x _ Purple Purple 3 Positive x x Purple Black 3 Negative x x Orange Orange 4 Positive x x Orange Black 4 Negative x Gra Positive Gray Black 5 Negative Yellow Yellow 6 Positive Yellow _ Black 6 Negative Brown _ Brown 7 Positive Brown X Black 7 Negative x x Tan 8 Positive x x STIMI 2 x x S INDORE E A gt gt gt gt gt gt gt gt gt Connect a monopolar probe with Universal handle or Incermenting Probe handle to the STIM 1 negative black jack on the patient interface Connect Patient Interface to the NIM 3 0 e DSP Test e Verifies DSP is running and tests the communication between DSP and SBC Audio Board Tests Headphone Handswitch functionality test Audio MuteProbe functionality test Main Board Tests Channel 1 functionality test Channel 2 functionality test Channel 3 functionality test Channel 4 functionality test Channel 5 functionality test Channel 6 functionality test Channel 7 functionality test Channel 8 functionality test Knob Board Tests The knob board self test verifies communication between the board and SBC Touch Screen Test Induces key presses and verifies SBC detects them correctly Sound File Downloa
17. e selectable 1 4 7 or 10 Hz 10 96 of setting Rate STIM 2 APS STIM repetition rates Slow 1 2 4 8 10 per minute Fast 1 2 Hz 10 96 of setting Stimulus Probe Monopolar standard or bipolar Stimulus Trigger Input TTL compatible remote switch for Selection of APS OFF SLOW and FAST repeating sequence Audio Output Transducers Built in 3 0 x 3 0 inch speaker Piezioelectric Sounder Baseline Audio Sound Level 63 4 db SPL C Weighted 30 5 cm Change in Baseline with added Channels lt 4 db SPL C Weighted 30 5 cm Change in Baseline due to EMG and Tones gt 20 db SPL C Weighted 30 5 cm Service Manual 17 Technical Specifications Max Audio Sound Level EMG amp Event Tone Signals Volume Preset and Limiter Current Delivered Tone Signals Power Down Power up Tone Touch Screen Key Click Connection Headphones Headphone Output Audio Accessories Verified Compatible Headphones Audio Amplifier Audio Extension Cable I O Printer Output Disk Drive Output Printer Interface Connection Printer Verified Compatible Printer Printer Power Supply Data Output USB Compact Flash Memory Video Output Interface Connection Electrical Input Voltage Frequency Total Power Consumption Auxiliary AC output For Use With Approved NIM Accessories Only Line Isolation Internal Fuse Patient Connections Patient Isolation Patient Connection Capacitance Classifications Type of Prote
18. ected and functioning properly 1 The Patient Interface and Simulator should have been connected before powering up If they were not then connect them now 2 Select Custom Procedure Simulation Test 3 The next screen to open will be Set up Step 2 of 2 Monitor Stimulation Test Step 2 of 2 Electrode Status Next Monitor 1 Ch1 2 Ch2 xXoeugeponos A 3 Ch3 4 Ch4 5 Ch5 6 Ch6 7 Ch7 8 Ch8 Stim 1 Return Stim 2 Return Ground pm B Show Details Print spumes einpe2oJd 7 04 2008 10 00AM x 4 Ifthe Check Electrode Panel is closed press the Check Electrode Tab if open proceed to step 7 5 Press the Show Details button Service Manual Annual System Quick Check Electrode Status 1 Ch1 Subdermal yp uo pono l A 2 Ch2 Subdermal 3 Ch3 Subdermal 4 Ch4 Subdermal 5 Ch5 Subdermal 6 Ch6 Subdermal 7 Ch7 Subdermal z Ch8 Subdermal Stim 1 Return Stim 2 Return Ground Hide Details 6 Electrodes screen opens At this display confirm e All channels are on e All channels have Subdermal selected e Positive and negative kQ impedance of all 8 or 4 channels is 5 1 KQ or 5 6 KQ 1 0 kQ The A difference in their values is 500 Q 500 Q The kQ impedance of the Ground is 6 5 KQ 1 0 kO The kQ impedance of the Stimulus Return is 6 2 kO 1 0 kO e Warning Monitoring is Disabled is on and flashing 7 Check off Confirming Electrodes in t
19. ent upon model color coded pairs of electrode inputs a ground connection a stimulus return connection and stimulator outputs that are configured to accept monopolar or bipolar stimulating probes Stimulator Probes and Handles The Stimulator Probes and Handles carry stimulus current from the console via the Patient Interface to the patient Monopolar Ball Tip Probe Ce mem nia G A Stimulus to Patient Contact Area B Insulated Sleeve C Probe Base Standard Prass Flush Tip Probe w G A Stimulus to Patient Contact Area B Insulated Sleeve C Probe Base Incrementing Monopolar Probe Handle The Incrementing Probe provides the ability to adjust the stimulus and to print or save events from within the surgical site Probe Jack Toggle Button Stimulus Plug Toggle Button Control Plug dep Universal Monopolar Probe Handle Q c A Probe Jack B Handle C Stimulus Plug Simulator The Medtronic Xomed NIM 3 0 Universal Patient Simulator provides for testing some of the features of the NIM 3 0 system without the need for patient interaction In addition the NIM 3 0 Universal Patient Service Manual Components Simulator is a convenient means of testing various aspects of instrument operability prior to patient application his section describes the NIM 3 0 Patient Simulator and pertinent components of the NIM 3 0 system used during a test NIM 3 0 Ef Medtronic A On the NI
20. he Annual System Quick Check Data Sheet Note If any of these condition are different check your set up if still incorrect contact Customer Care Electrode Lead Off This test simulates what happens when contact with an electrode is lost 1 Starting at the Monitoring Screen all adjustments are at default values I Disconnect the positive lead from Channel 1 II For three seconds e Channel 1 shows a background noise waveform e Artifact Detected is displayed on the zero 0 amplitude line in yellow e There is a continuous noise This is due to ambient electronic noise being picked up by the disconnected electrode III After 3 seconds the alarm stops and Electrode Off is displayed on the zero 0 amplitude line in yellow with the background noise waveform 2 Reconnect the electrode and confirm the NIM 3 0 returned to normal operation 3 Repeat test for all channels 4 Check off Electrode Lead Off in the Annual System Quick Check Data Sheet Note If any of these condition are different check your set up if still incorrect contact Customer Care Stimulation Mechanical Stimulation The positive and negative patient stimulator electrode cables are sensitive to touch mechanical stimulation and will generate EMG visual tone responses when manipulated tapped These simulated responses appear as spontaneous burst like responses 1 Start at the Monitoring screen with default settings with all electrode
21. imulation EMG Stimulating and Tones Threshold Increase Test m e e o p System Safety Check according to IEC EN60601 1 Medtronic Xomed recommends System Safety Checks to be scheduled at yearly intervals IEC EN60601 1 Safety Analysis In accordance with local procedures perform a complete Safety Analysis for a Class 1 Type BF Device on the NIM Console Utilize Ground connector found on rear of console as Chassis ground For Patient Leakage and Mains on Applied Parts tests a Patient Interface must be attached to the NIM Console with electrodes connected to each channel Ensure Ground Impedance is less than 0 252 Os when measured with a 25 Amp source Record in a below l High Potential Hi Pot Testing A 1 a c In accordance with local procedures perform the following Hi Pot tests on the NIM Console Note Perform Test at voltages indicated and record values in space as needed Safety ground to Line Neutral Apply Hi Pot to Line and Neutral of Power Inlet of NIM Console while monitoring Ground Applied Parts to line neutral Apply Hi Pot to Line and Neutral of Power Inlet while monitoring Applied Parts Precaution Use DC voltage only when performing Applied Parts Hi Pot test AC Hi Pot voltage to Applied Parts will damage the device System Safety Check Manufacturers Specifications Recorded Value a Ground impedance 0 2520 25 Amps b Safety ground to Line Neutral 5 0 mA 1500 Vac c Applied Parts to li
22. ms screen Intertwined recording electrode and stimulator Disentangle recording electrode and stimulator cables wires Inadvertent manipulation of electrode wires Check area near recording electrodes for excessive Patient Interface cable or recording area on stretching from tape drapes etc patient Electrical interference from other equipment Check for intermittent stimulation from anesthesiologist i e hand held electrical stimulator Move NIM 3 0 system away from source of interference Make sure Patient Interface cable and electrode wires do not cross other electrical equipment or cables 16 Service Manual Technical Specifications Technical Specifications Physical Dimensions Size 30 cm W x 33 cm H x 27 cm D Weight 6 8 Kg Operational Environment Operating Temperature range 10 to 40 C Operating Humidity 30 70 RH non condensing Atmospheric Pressure range 700 kPa to 1060 kPa Mode of Operation Continuous duty Transport and Storage Environment Shock and Vibration Verified to Standard ISTA 2A Ambient Temperature range 40 C to 70 C Relative Humidity range 10 to 100 including condensation Atmospheric Pressure range 500 kPa to 1060 kPa Amplifier NIM Response 3 0 Ch 1 4 NIM Neuro 3 0 1 8 Individually and simultaneously selectable Input Sensitivities 5 10 000 uV peak to peak AC coupled Sensitivity Selection Automatically zeroed Bandpass 15 Hz 1 85 kHz 3 db 500 Hz EMG Displa
23. ne neutral 1 0 mA 3535 Vdc Perform an operational check using the Patient Simulator and the Patient Interface Please see the NIM 3 0 and Patient Simulator User Guides for details Service Manual 11 Cleaning and Maintenance USB Drive Tektronix TDS 360 Oscilloscope or equivalent BNC BNC Cables of various lengths BNC Female Male Female Connector T Connector Optional Note Estimated time to perform testing with all components is 4 6 hours Cleaning and Maintenance Cleaning after each use he patient simulator patient interface and cable Muting Detector and cable s printer printer cable power cords headphones USB compact flash and the NIM Neuro 3 0 System monitor e Disconnect all cabling from rear of the monitor e DO NOT immerse or sterilize the units e Wipe down the units with a cloth dampened with a neutral enzymatic detergent pH 6 0 8 0 or phenol based disinfectant e Do not use alcohol other solvents or abrasive cleaners e Drytheunits with a clean non abrasive cloth Advanced System Check Advanced System Check reqiires the use of the Biomedical Test Kit sold separately Patient Interface Simulator Plug P N 66161714 1Each Storage Banana Plug Jack Adapter 1 kilo ohms Resistor P N Allow the NIM 3 0 System and accessories to thoroughly air dry before 11320038 1 Each storing in a cool dry place See Technical Specifications for further information Maintenance Medtronic Xomed is
24. of two or more options Radio Button Selected Check Box Deselected For option selection where choice is to enable or disable a single or multiple options Check Box Selected EMG Audio and Event Tones Check Boxes One or both must be selected Both cannot be deselected Red X Indicates a failed test Green Check Indicates a successfully passed test Orange Check Indicates an Active Channel Select Button Option Button See associated text indicating option Help Button Opens Help Screen for Electrode Placement amp Sound Samples Increase Button Increases value Setting Decrease Button Decreases value Setting 0058 Monitor Button Opens Monitoring Screen Measure Button To view details of the event waveform Advanced Settings Button Opens Audio Monitoring Stimulation Microscope and APS Panels Display Button Opens panel for adjusting amplitude and time scales Save Button Sends selected information to USB mass storage device Print Button Used in Reports Section to print reports Freeze Button Freezes entire screen all channels Snapshot Button Saves current screen to memory or to selected peripheral device B Activate Button Activates STIM 2 stimulus adjustment buttons Baseline Button Initiates an APS baseline acquisition sequence B Electrode Check Button Opens Electrode Status Panel Delete Close Button Closes Delete Procedure dialog box Open
25. r disposal of this product Do Not Use If Package Is Open Or Damaged Package Contents Use By Date Q BUND LOT eee Fuse LOT Be Ji O O E Fri REF Catalog Number Is Approximately Equal To Sterilized By Radiation Do Not Use If Package Is Open be i Sterilized By Ethylene Oxide Do Not Use If Package Is Open Or Damaged E Authorized Representative In The European Community This Device Complies With Medical Device Directive 93 42 EEC Caution Federal Law U S A Restricts This Device To Sale By Or On The Order Of A Physician Quantity Date Of Manufacture x FANIE ANIZ 0123 E ame Buttons and Indicators 6 ROHS Environmental Friendly Use Period China SJ wy T11364 2006 Conforms To IEC EN60601 1 Certified To CSA C22 2 No 601 1 ji Consult Instructions For Use A Attention See Instructions For Use Protected Against Vertical Water Drops Protected Against The Effects Of Temporary Immersion In Water Rated For Water Ingress IEC 60529 Type BF Applied Part Manual Start Stop Rf Transmitter Interference May Occur Snapshot Option Send Snapshot to USB Storage Indicates a USB Storage Device is connected Buttons and Indicators In this section all buttons used on the Touch Screen User Interface are displayed with an explanation of how they work Radio Button Deselected For option selection where choice is limited to one
26. rrent B3 Decrease current B4 Press and hold saves current screen to memory or to selected peripheral device Printer or USB flash drive 11 Check off EMG Stimulating and Tones in the Annual System Quick Check Data Sheet Note If any of these condition are different check your set up if still incorrect contact Customer Care Threshold Test 1 Decrease Event Threshold to 20 uV 2 Press the channel 1 electrode wire with finger At this point the monitor will be picking up electronic noise higher that the threshold setting causing multiple event tones to sound 3 Turn On select Auto Threshold Check Box 4 Press the channel 1 electrode wire with finger and observe continuous event alarms sounding for 10 seconds e after 10 seconds Threshold Increase is announced event tones no longer sound e the new threshold value is displayed next to the channel number Note Auto Thresholds maximum is 400 uV Holding a channel electrode wire between thumb and forefinger or pressing the wire to hard can generate signals greater than the maximum In this case the threshold will increase to 400 uV but alarms will continue to sound 5 Repeat for remaining channels 6 Check off EMG Threshold Increase Test in the Annual System Quick Check Data Sheet Note If any of these condition are different check your set up if still incorrect contact Customer Care Simulation Troubleshooting Should you encounter any difficult
27. s Delete a Custom Procedure dialog box Global Settings Button Global Settings allows the user to select screen language date time format and the Diagnostic Mode as well as set system date time and Restore Factory Defaults 2 BB Information Button Opens Information Screen to enter e Surgeons Name e Patients Name e Notes Fast Rate Button Selects APS Pulse Fast Rate Normal Rate Button Selects APS Pulse Normal Rate Next Button Opens the next screen or graphic display 88D Service Manual Previous Button Opens the previous screen or graphic display Yes Button Accept Keep No Button Do not Accept Keep Accept Button Function as indicated B 5 o a0 Repeat Button Function as indicated Cancel Button Function as indicated O amp O D Show Details Button Used to show impedance readings Hide Details Button Used to hide impedance readings OK Button Used to close panels Select All Button Used to select all events in memory Deselect All Button Used to deselect all events in memory 20088 Scroll Up Down Buttons Used to scroll through selected events 0 Restore Button Used to restore factory defaults Mute Button Used to mute channel Unmute Button Used to unmute channel APS Visual Alarm Indicator and Mute Button Automatic On Off Indicator Button Only displayed when an APS alarm limit has been reached and APS alarm tone sounds Also used to m
28. s connected Note Detect Artifacts check box Advanced Settings button Monitoring tab should by default be selected On if not turn it On select 2 Lightly tap the electrode connectors 3 Observe e You should hear single beep as each channel is tapped e Alarm tones are lowest for channel 1 and highest for channel 8 e You should see sharp spike like waveforms on the screen with the words Artifact Detected displayed in association to the waveform e Tapping multiple cables will produce multiple alarms and waveforms Annual System Quick Check mechanical Event simulator Event 4 Check off Mechanical Stimulation in the Annual System Quick Check Data Sheet Set and Measure Monitor A Control Panel Volume Je Tumas 100 pV 3 Thursday April 05 2008 1 Start at the Monitor screen default settings with all electrodes connected using a monopolar probe with universal handle or incrementing probe handle with Prass tip 2 Check stimulus adjustment buttons I The upper left of the screen should read 0 8 this is the mA setting II Below the mA setting is a small window reading 0 00 mA This is the measured value III Press the Minus and Plus buttons observing that the mA setting changes values IV Press the mA button until reaching a value of 3 00 mA e A dialog box will open Stimulus in excess of 3 milliamperes Press OK to allow stimulus Press OK 3 Touch and hold the stimula
29. sb Mecitrornuc Service Manual a z gt SP Medtronic Setup E Information E Information Step 1 of 2 1 Select Procedure Step 1 of 2 1 Select Procedure Setup Neuro Otology Neuro Otology Head Neck Head Neck Peripheral Peripheral Custom Procedures Custom Procedures 2 indicates default settings have been changed Global Help Settings 5 1 2009 9 00 AM GUI vxXXX X2O000X DSP vxxx x xxxxxx indicates default settings have been changed Global Help Settings 5 1 2009 9 00 AM GUI vXXXX X XXXXX DSP vxxx x xx xxxx Instructions For Use Medtronic Xomed Inc 6743 Southpoint Drive North Jacksonville FL 32216 USA www medtronicENT com Help Line 800 874 5797 are trademarks and are registered marks of Medtronic Xomed Inc he information contained in this document was accurate at time of publication Medtronic reserves the right to make changes in the product described in this manual without notice and without incorporating those changes in any products already sold Table Of Contents Sym DOl ea NU I IM NNNM 3 Table Of Contents 3 Buttons and Indicators 4 System Descrip Oisein priiis 5 Device Descrip UON esini de doro Ne EE 5 Incications for seu Lu eR abra reser eR tet Rove ERNA rapa GE Ure spia ERANA 5 Contraindications co docete oed Dre eere tes Ia
30. sed It must be Xomed Fuse Kit 8253075 similar 32 mA Type F 250V 5 x 20 mm fuses may not offer the same degree of protection 14 Service Manual Troubleshooting Troubleshooting Solution No visual display or audio alarms at Power cord not connected to outlet or to the lug in power cord power up NIM 3 0 system Power switch not turned on urn power switch on Electrode impedance is too high gt 10 KO for subdermal electrodes gt 25 KO for Prass paired electrodes 05 KO for EMG tube 40 KO for hookwire electrode Electrode impedance x 0 1 KO Electrode dislodged from patient but not Insert dislodged electrode tape down in place Remove and replace with new electrode Check connection at Patient Interface box Positive and negative electrodes touching below Remove and relocate electrodes 77 too z 2 REL s en S O KD F Q olla amp ale Po zo za EE zi 2 s IE ME 5 io m ES Be V O 2g e or e Cu E cr 3 cof W tr a et x o B LE lt o z ge C Qu D Q p particularly in EMG Use tap test near electrodes to evoke EMG or artifact tubes increase threshold decrease volume for test If activity is noted on channel in question proceed Re insert electrode in question Electrode reading is Remove and replace electrode in question Check connection to Patient Interface box Electrode difference is greater than Remove and
31. ting probe to channel 1 of the Patient Simulator and Observe e Stimulus waveform on channel 1 see Example Stimulus and Spike Waveforms e Stimulus tone sounds steady repeating beep e Raw EMG can be heard a popping sound accompanying the stimulus tone e mA Measured is 5 of the mA setting e The uV reading is displayed to the right and above the zero 0 amplitude line in yellow and boxed Repeat test for all channels Set mA button to 1 00 mA and Event Threshold to 100 uV Stimulate channel 1 and observe that stimulus tone sounds repeating beep and raw EMG can be heard a popping sound accompanying the stimulus tone Events 100 pV Event Threshold 0 00 uV ATUA 7 Increase the Event Threshold to 500 uV and stimulate channel land observe e Stimulus waveform on channel 1 Stimulus tone is NOT heard Raw EMG can be heard a popping sound mA Measured is 5 of the mA setting The uV reading is displayed to the right and above the zero 0 amplitude line in yellow and boxed 8 Repeat for remaining channels 10 9 Move the Stimulator and STIM 1 Return to STIM 2 and repeat steps 2 3 and 7 using any channel aa 10 If a Remote Incrementing Probe is available check the stimulus adjustment as shown in the B 2 B3 and B4 illustration If all 8 channels have been tested it is acceptable to test the remote probe on any one channel B1 Toggle button normal or at rest B2 Increase cu
32. udio feedback to increase the usability of the device Indications for Use The NIM 3 0 is intended for locating and identifying cranial and peripheral motor and mixed motor sensory nerves during surgery including spinal cord and spinal nerve roots The APS electrode is an accessory intended for providing automatic periodic stimulation to nerves when used with the Medtronic Nerve Monitoring Systems Indications for NIM 3 0 EMG Monitoring Procedures include Intracranial Extracranial Intratemporal Extratemporal Neck Dissections Thoracic Surgeries and Upper and Lower Extremities Indications for Spinal procedures which may use NIM 3 0 EMG monitoring include Degenerative Treatments Pedicle Screw Procedures Fusion Cages Rhizotomy Orthopedic Surgery Open and Percutaneous Lumbar and Cervical Surgical Procedures and Thoracic Surgical Procedures Contraindications The NIM 3 0 is contraindicated for use with paralyzing anesthetic agents that will significantly reduce if not completely eliminate EMG responses to direct or passive nerve stimulation Components Customer Care Medtronic Xomed Inc 6743 Southpoint Drive North Jacksonville FL 32216 USA www medtronicENT com Help Line 800 874 5797 International Service International customers should contact their local Medtronic Xomed office Introduction The NIM 3 0 System is intended for intraoperative use during surgeries in which a motor nerve is at risk due to
33. ute APS alarm APS Alarm Button Used to un mute APS alarm 2 D ry P Channels Channels Button Opens a drop down menu used to name channels 06660 Channel Buttons Channels can be turned On Off or Muted Decrease Increase Buttons and Setting Display Used to make adjustments to the subject as defined in the open Service Manual Buttons and Indicators Multi State Buttons Set Up used as an example Gray Inactive not selectable Blue Selectable Orange Selected Set Up Button Opens Starts the setup process Monitor Button Opens the Main Monitoring Screen Reports Button Opens the Reports Screen Please Wait Program Loading Indicator System Description Device Description The NIM Neuro 3 0 is an eight channel the NIM Response 3 0 is a four channel EMG monitor for intraoperative use during surgeries in which a nerve is at risk due to unintentional manipulation The NIM 3 0 System records electromyographic EMG activity from muscles innervated by the affected nerve The monitor will assist early nerve identification 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 by alerting the surgeon when a particular nerve has been activated The monitor utilizes touch screen and color graphic user interface GUI along with the a
34. y 200 Hz 1 0 kHz 6 3 db 500 Hz Audio EMG Speaker Input Noise 3 14 mV p p lt 5 uV RMS DC 4 Hz inputs shorted Input Impedance 10 Meg Ohm DC offset Rejection 1 00 VDC Rejection Common Mode Rejection gt 80 dB 60 Hz balanced inputs gt 66 dB 60 Hz 1 KOhm imbalance Channel Enable Disable Controls Dedicated function touch pads for independent Ch enable disable Event Threshold Control and Display Adjustable Graduated Touch Bar with Voltage threshold displayed Patient Isolation 1 000Vrms 60Hz lt 100 u A Impedance Measurement Control Automatic CHECK ELECTRODE feature Measuring Signal 10mV peak to peak 400 Hz Sinewave Measurement Range 0 200KOhm 20 or 100Ohm Artifact Detection and Rejection Stimulus Artifact Synchronized and adjustable muting Bipolar Electrocautery Rejection Continuous Monitoring During Bipolar Cautery lt 40 watts Electrocautery ESU Interference Automatic detection and muting Muting Detector Input ESU Sensitivity ESU Cut Coag Contact 5 100 Watts Air Discharge 10 100 Watts Muting Console Input Sensitivity Muting 0 6 2 0 Volts Vrms Non Muting lt 0 3 Volts Vrms Muting Detector Input ESU Immunity ESU lt 100 Watts Cut Coag or lt 3 0 Vrms 100 800 KHz Sq Wave Electrode Lead Off Automatic detection muting and warning Display Touch Screen Type High contrast digital graphic Color visible in complete darkness Resolution Display 1024 H x 768 W pixels Touch Panel 256
35. y eliciting simulated responses from the NIM 3 0 System Patient Simulator check the following e Verify that Stimulus Measured is approximately the same as Stimulus Intensity e Make sure the jumper cables are connected correspondingly between the SIMULATOR and PATIENT INTERFACE e Adjust the EVENT THRESHOLD setting on the NIM Neuro 3 0 System e Adjust the STIMULUS intensity on the NIM Neuro 3 0 System for adequate output e Clean the stimulator contacts of debris e Check the integrity of the stimulator or stimulus dissection instrument and its connecting cable e Check for blown fuse in NIM Neuro 3 0 System Patient Interface and replace with proper valued fuse shown near fuse box e Check for proper closure of fuse holder in the NIM Neuro 3 0 System Patient Interface Service Manual Annual System Quick Check Data Sheet Annual System Quick Check Data Sheet Preventive and Corrective Maintenance User maintenance for the NIM 3 0 is limited to visual inspection before use and periodic cleaning Annual System Quick Check with Simulator and System Safety Checks according to IEC EN60601 1 is recommended Please see Warning W14 in the Users Guide Model S N Tester Date A System Quick Check with Simulator A a f Z Use Patient Simulator to confirm appropriate behavior Refer to the Patient Simulator Appendix C to confirm the following System Setup AZ Confirming Electrodes Electrode Lead Off Mechanical St
Download Pdf Manuals
Related Search