CADWELL Sierra Summit User Manual
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CADWELL Sierra Summit User Manual

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Summary of Contents for CADWELL Sierra Summit

  • Page 2: Table Of Contents

    Non-Cadwell supplied Computer ..................... 6 Back Panel Connections ........................7 Turning Equipment On and Off ......................9 Opening and Closing Sierra Summit Software ................10 Verification and Basic Operation ....................... 11 Summit Setup Verification......................11 Ultrasound Setup Verification ....................... 22 EMG+ Operation ...........................
  • Page 3 Recommended Stimulating Electrodes ....................88 Maintenance ............................. 89 Specifications, Operating Environment & Limits ................90 Electromagnetic Compatibility......................90 Cleaning and Disinfection ........................95 Disposal ............................99 Customer Support ........................... 100 Cadwell Address .......................... 100 Warranty Information ........................101 Electrode Catalog and eStore ......................101...

  • Page 5: Disclaimer

    Features and specifications are subject to change without notice. Cadwell Industries, Inc., does not accept any liability for the use or misuse, direct or indirect, of this product. Users must accept all responsibility for any results obtained by or concluded from data obtained by the product.

  • Page 6: Overview

    Electromyography (EMG), Nerve Conduction Studies (NCS), Evoked Potentials (EP), and Autonomic Reponses (RR Interval Variability). The Cadwell Sierra Summit is used to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions.

  • Page 7: Common Applications Include

    (RNS) testing. They are intended for use only during the duration of the procedure. The Sierra Summit/Ascent system is intended to be used by personnel trained to perform the intended tests. The system is used primarily in a clinical setting to diagnosis neurological disease (peripheral nerve disorders, muscle disorders, central nervous system disorders).
  • Page 8 f) Patient Condition: awake, sedated, or asleep. Part of the body or type of tissue applied to or interacted with a) Measurement Site: - skin over peripheral nerves and muscles - scalp overlying the somatosensory or motor cortex - intramuscular (needle EMG) b) Stimulation Site: - skin over peripheral nerves and muscles c) Condition:...

  • Page 9: Setup Instructions

    You should receive the following as standard items: • Sierra Summit Base Unit with detachable power cord. • Backup Sierra Summit installation software media (DVD or USB). • Either a 1-2 Channel or 3-12 Channel Amplifier. • One (1) StimTroller Plus handheld electrical stimulator.

  • Page 10: Cadwell Supplied Computer

    If you purchased your computer from Cadwell, all necessary Windows and Sierra Summit software is already installed on your computer from the Cadwell factory. There is no need for you to install any software. Please put the installation media (DVD or USB) that came with your system in a safe place.

  • Page 11: Back Panel Connections

    Back Panel Connections The following connections correlate with the peripheral device connection indicated in the image of the Sierra Summit base below. 1. Evoked potential stimulator (headphones, inserts, bone transducer, LED goggles) 2. StimTroller PlusTM connections 3. Amplifier Input 4. Trigger Input connections 5.
  • Page 12 ESTIM-1: Connection for Electrical Stimulator Handle #1. ESTIM-2: Optional connection for Electrical Stimulator Handle #2. Amplifier: Connection for the digital amplifier. Trigger Input 1-2: Connection for Trigger Input signals #1 and #2. Trigger Input 3-4: Connection for Trigger Input signals #3 and #4. Trigger Output 1-2: Connection for Trigger Output signals #1 and #2.

  • Page 13: Turning Equipment On And Off

    POWER: Connection for hospital-grade power cord and I/O switch. 100-240Vac, 50-60Hz, 180VA. Turning Equipment On and Off Note: Do no turn the Sierra Summit instrument base on or off while a patient is connected. To turn the equipment On: 1. Connect the amplifier, stimulators, and other accessories to the Sierra Summit base unit (if not already connected).

  • Page 14: Opening And Closing Sierra Summit Software

    Click the Windows Start button, select All Programs, Cadwell, and then Sierra Summit. Note: If you receive a Communication Error message: Close the Sierra Summit program and make sure the Sierra Summit base unit is turned On, and that the USB cable is attached securely between the computer and the Sierra Summit base unit.

  • Page 15: Verification And Basic Operation

    If you receive a Communication Error message. Close the Sierra Summit program and make sure the Sierra Summit base unit is turned On, and that the USB cable is attached securely between the computer and the Sierra Summit base unit. Then, restart...
  • Page 16 Login Window After launching the Sierra Summit program, the Cadwell User Login window will be displayed. You will need to select a user name from the drop-down list and then enter the appropriate password. If no users have been created, select the Admin user and enter the password admin.
  • Page 17 Knob #1 on the Sierra Summit base unit to move from field to field. At a minimum, you should enter a Last Name and First Name, this is what the Sierra Summit program uses to create the patient's data file.
  • Page 18 Selecting the NCV Test Protocol Select the NCV Test Click the F3 - New Study button. The patient information will be saved and the Navigator window will be automatically displayed. Select the NCV test protocol from the All Tests tab. A nerve list will be displayed allowing you to pick the nerve or nerves that you will be testing on the patient.
  • Page 19 Follow these steps for performing a routine Median Motor nerve conduction study. 1. Electrode Placement Attach the electrodes to the patient as shown in the following diagram. Median Motor Recording Setup and Wrist Stimulation...
  • Page 20 Screen, will flash Green and the patient's response will be displayed. The Knob #1 (Intensity/Single) on the Sierra Summit base unit can also be used to adjust stimulus intensity and deliver a single stimulus. Continue to increase the intensity level and stimulate until a supra-maximal response is acquired.
  • Page 21 Site table (Elbow) is automatically highlighted. If the nerve has only one stimulation site, it is not necessary to store the response. The Sierra Summit will automatically keep the trace when you change nerves or test protocols.
  • Page 22 • Press the F1 - Distance key on the Sierra Summit base unit or click on the appropriate distance field with the mouse. The distance field will become activated and a small pop-up window is displayed showing the segment name and a place for the distance measurement, type the distance value and then press the Enter key.
  • Page 23 7. Verify Responses Your screen and the recorded responses should be similar in appearance to those shown in the following example. Median Motor study with Wrist and Elbow responses...
  • Page 24 Generate a Report The Sierra Summit uses a separate program for report generation, this program is called QuickReport. QuickReport is a Microsoft Word based application and includes such Word features as spell check, grammar check, table formatting, and graphics support.
  • Page 25 QuickReport is closed and you are returned to the median motor test screen. To get a simple printout of the current test screen, select Print Screen from the Sierra Summit File menu. Moving the Exam to the CadLink Database Once the patient exam has been closed it can be uploaded to the CadLink database, or it can be kept in the user's local data folder.

  • Page 26: Ultrasound Setup Verification

    Confirm upload to database Closing the Sierra Summit Program To close the Sierra Summit Program. • Click on the File menu and select Exit Sierra Summit. • Click on the red X in the upper right-hand corner of the screen.
  • Page 27 1. Connect the Transducer to the front of the MicrUS. 2. Connect the USB cable from the MicrUS to an available USB port on the Summit Base Unit. 3. Connect the Summit Base Unit to an available USB port on the PC or Laptop computer. MicrUS connected to the PC or Laptop: (Option 2) 1.
  • Page 28 Ultrasound Software Verification Select the Ultrasound Test: • If a Study has already been selected, simply click on the ultrasound site name (i.e., Median - Wrist) within the Study window. • If a Study has not been selected, or you don't want to use a Study. Select the individual Ultrasound test protocol from the Navigator window, a ultrasound site list will be displayed allowing you to pick the anatomical site you will be scanning on the patient.
  • Page 29 2. Verify that the correct scanning presets have been loaded. Shown on the left side of the ultrasound window. The scanning presets (parameters) are shown in the control panel on the left-hand side of the ultrasound window. To change these settings use one of the following methods: •...
  • Page 30 3. Begin Scanning. Position the transducer (probe) and begin scanning. If needed, adjust the presets as described above to optimize the image. Be sure to use adequate ultrasound gel at the scanning site. 4. Freeze the Image. To freeze the image on the screen, do one of the following: •...
  • Page 31 6. Measure important structures (optional). Measurements such as distance or area can be performed by using the Measurements control panel on the right side of the ultrasound window. Please refer to the Echo Wave II User Manual (page 92) for detailed instructions on using the measurement tools.
  • Page 32 7. Annotate (label) the image (optional). Annotations or labels can be added to the image by using the Annotations control panel. This panel is normally hidden from view and will appear when you hover the mouse over the right- hand edge of the Measurements control panel. Annotation control panel (green box) and example image with cross-sectional area measurement and label.
  • Page 33 9. Add a comment to the stored image node (optional). An optional comment can be added to the stored image node in the Study window. To do this right-click over the image node and select "Change Comment" from the context menu. Enter your comment and click OK.

  • Page 34: Emg+ Operation

    11. Select a different Body Site (optional). To select a different body site, press the F7 (Navigator) function key on the Summit base unit. The Navigator window will be displayed. Select a new site from the list, then confirm the side setting at the bottom of the window.
  • Page 35 During EMG+ data acquisition you can easily adjust the Gain and Sweep Speed by using Knob #3 (Gain / Sweep) on the Sierra Summit base unit. Simply turn the knob to adjust the gain, to change the sweep speed, press the knob first to toggle it to the sweep mode, then turn to change the sweep speed.
  • Page 36 9. Modify Muscle Scoring With the Automatic Muscle Scoring feature enabled, as soon as a muscle is selected in the Study window, or added to the Study window using the F7 (Muscle List) function key, it is automatically added to the Muscle Scoring Table and is scored as normal. To change the muscle scoring for a muscle: •...

  • Page 37: Sfemg+ Operation

    During SFEMG+ data acquisition you can easily adjust the Gain and Sweep Speed by using Knob #3 (Gain / Sweep) on the Sierra Summit base unit. Simply turn the knob to adjust the gain, to change the sweep speed, press the knob first to toggle it to the sweep mode, then turn to change the sweep speed.
  • Page 38 7. Acquire Single Fiber Potentials Once the appropriate single fiber signal is located and the Trigger and Delay positions have been adjusted, acquire potentials until the Peak Plot window makes one complete cycle (one cycle represents 100 captured traces). The number of traces is also shown in the top-right of the Triggered Traces window.
  • Page 39 8. Stop Data Acquisition Press the Run/Stop key on the Sierra Summit base unit to stop data acquisition. This will change the display to the Review mode. Peak Plot window: In review mode, the Peak Plot window displays the firing frequency (Hz) of the reference (trigger) peak and the real-time jitter measurement for the other peaks in the recording.
  • Page 40 • Click on a trace in the Triggered Traces or All Traces windows. Vertical lines are drawn on either side of the data points to indicate the standard deviation limits for the peak latency. The standard deviation limit is specified in the cogwheel menu of the Triggered Traces window.
  • Page 41 Triggered Traces window: In review mode the Triggered Traces window is synchronized with the Peak Plot window. The currently selected trace in the Peak Plot window is shown in the factory default purple color in the raster or overlay stack and is also shown offset at the top of the window. To select another trace, do one of the following;...
  • Page 42 9. Manually Reject Traces Traces can be manually excluded from the analysis by one of the following methods: • Triggered Traces window - Raster On: In the raster mode, move the mouse over the trace you want to exclude, the trace will change to light green color, now right-click the mouse to exclude it.
  • Page 43 • Using the All Traces window Use the mouse to draw an exclude box around a portion of the trace(s) you want to exclude. When you release the mouse button those traces that pass within the box will be excluded and will be removed from the All Traces window. To Reset and Reanalyze Traces: Click the reanalyze icon to automatically include all previously excluded traces.
  • Page 44 11. Review the Numerical Data The Results Table records the analysis results for each run and calculates the mean and standard deviation values. Results Table - Run #4 is selected. Table Columns: Run – indicates the run #. If a run contains more than one analyzed potential pair, it is indicated by .2, .3, .4.

  • Page 45: Ncs+ Operation

    13. Select Next Muscle (optional) From Acquisition mode, press the Next button on the base unit to highlight the next muscle in the Study window. If the muscle you want to examine is not displayed within the Study window, press F7 (Navigator) and select the next SFEMG+ muscle from the list.
  • Page 46 5. Verify Amplifier Settings Check the Gain, Hicut, Locut, and Sweep Speed settings and make sure they are appropriate for the nerve being tested. Typical Settings Gain Hicut Locut Sweep Speed (Hz) (Hz) (ms/Div) Motor Nerves 2 to 5 mV/Div Sensory Nerves 10 to 20 uV/Div F Wave...
  • Page 47 The pulse width (duration) can be adjusted using the PW up and PW down arrow keys on the base unit. The displayed units can be either microseconds (us) or milliseconds (ms). Repetitive stimulation can be delivered by pressing the Run/Stop button on the base unit, or by holding down the StimTroller’s Stim button for 2 seconds.
  • Page 48 Example showing normal amplitude and prolonged latency. To remove a marker, click and drag it outside the trace window on the right-hand side. To set a missing marker, click on the response (trace) to place the marker. To indicate a missing response, perform one of the following actions: •...
  • Page 49 15. Continue to stimulate and store sites on the nerve 16. Enter Distance Verify that the correct distance field is selected in the Segment table. If not, left-click on the distance field or press Enter until the appropriate field is highlighted. Perform one of the following actions to insert a distance: •...
  • Page 50 18. Compare Left and Right side (optional) Press the F6-L/R Compare function key or the L/R Compare tab in the Result Table window, to overlay Left and Right traces, and show Left/Right comparison tables. Markers can be adjusted and new recordings can be obtained in L/R Compare mode. Press the F6-L/R Compare function key again, or the Tables tab in the Results window, to exit the Left/Right compare mode and only show traces and results for active side.

  • Page 51: Rns Operation

    20. Review (optional) All recorded and planned Tests/Nerves are listed in the Study Window. Tests containing recordings are indicated with a check mark. Click on any Test with a check mark to review traces and results. 21. All Tests (optional) Press the F5-All Tests function key to see all recorded nerves and results for this patient.
  • Page 52 Controls Window. Controls Toolbar. Normal mode (right probe is Cathode). In the Reversed mode, the electrical stimulator image on the screen will show the Left-side probe as the cathode (-). The polarity field on the screen will indicate Rev. Controls Window. Controls Toolbar.
  • Page 53 The stimulator light, located next to the intensity level on the Screen, will flash Yellow and the patient's response will be displayed. The Knob #1 (Intensity / Single) on the Sierra Summit base unit or the Single button within the on-screen RNS Controls window can also be used to deliver a single stimulus.
  • Page 54 The timer automatically resets to zero after each train is stored. You can also manually reset the timer to zero by pressing the F2 (Reset Timer) function key on the Sierra Summit base unit.
  • Page 55 Example RNS Traces Automatic Stimulus Train Delivery: Change the Auto Seq. control from Off to On (F5 key). The first row in the RNS Table will be automatically highlighted. Press the Stim button on the electrical stimulator handle. A train of stimuli will be delivered to the patient and a trace will be displayed for each stimulus within the train.
  • Page 56 9. Adjust Cursors (optional) Onset (O) and Peak (P) cursors are automatically placed on the selected responses (see Response 1 and Response 2 settings above) as each train is acquired. The amplitude (onset to peak) and area (negative peak) of each response is calculated and displayed in the RNS table window. The positions of these cursors can be adjusted by performing one of the following actions;...

  • Page 57: Blink Reflex Operation

    RNS Histogram Window Blink Reflex Operation Select the Blink Test: • If a Study has already been selected, simply click on the Blink test protocol within the Study window to highlight the test. • If a Study has not been selected, or you don't want to use a Study. Select the Blink test protocol from the Navigator window.
  • Page 58 Responses collected during right side stimulation display in the bottom half of the screen. Eliminating the need to change electrodes at the amplifier, the Sierra Summit automatically inverts the order in which trials collected during right side stimulation are displayed so that the ipsilateral response (Ch2 : R) appears above the contralateral response (Ch1 : R).
  • Page 59 Yellow and the patient's response will be displayed. Knob #1 (Intensity/Single) on the Sierra Summit base unit can also be used to adjust stimulus intensity and to deliver a single stimulus. Turn this knob to adjust the stimulus intensity, and press the knob to deliver a single stimulus to the patient.

  • Page 60: Sep Operation

    9. Change the Side and Repeat steps 4 - 8. Selecting a different side automatically stores the currently active (white) traces. Blink Example - screen split vertically. The program will automatically calculate the R2i-R2c difference for each side. It will also calculate the Left minus Right differences for R1, R2i, R2c, and R2i-R2c.
  • Page 61 Determine the number of channels that will be recorded and the electrodes that will be required for each channel. Apply the recording electrodes and ground electrode to the patient and connect to the Sierra Summit amplifier. With the 2 Channel Amplifier, if the same electrode is used as the reference in each channel, use a Reference Jumper to connect this electrode into both reference (+) inputs on the amplifier.
  • Page 62 2 Channel Impedance window. 3-12 Channel Impedance window. 2 Channel Amplifier: The impedance values for the Active (-) and Reference (+) inputs are displayed for each channel as well as the Ground electrode. If a Channel is turned Off, no impedance values will be calculated for either the active or reference inputs and the word "Off"...
  • Page 63 Intensity - start at zero milliamps and after data acquisition is started increase slowly until a visible muscle twitch is seen. Pulse Width - typically set to 100 or 200 microseconds. Rep Rate - typically between 2 to 5 Hz and not directly divisible into 60 (e.g., 2.11, 2.66, 4.77). Polarity - set to Normal (Nml) mode.
  • Page 64 You can check the Amp Gain setting by pressing the F1 (Avg / Live) function key to switch to the Live mode. Press the function key again to return to the Avg mode and view the Display Gain setting. 7. Acquire Responses A.
  • Page 65 F. Repeat steps A - D and collect data for the opposite side. Example 2 Channel Median SEP, Left and Right. 8. Trace Positioning (optional) If the position of the traces needs to be adjusted, follow one of these procedures. •...

  • Page 66: Aep Operation

    Determine the number of channels that will be recorded and the electrodes that will be required for each channel. Apply the recording electrodes and ground electrode to the patient and connect to the Sierra Summit amplifier. With the 2 Channel Amplifier, if the same electrode is used as the reference in each channel, use a Reference Jumper to connect this electrode into both reference (+) inputs on the amplifier.
  • Page 67 2. Verify Amplifier Settings Check the Gain, Hicut, Locut, and Sweep Speed settings and make sure they are appropriate for the selected AEP test. Typical AEP Settings Gain = 0.2 to 0.5 uV/Div Hicut = 3k Hz Locut = 100 Hz Sweep Speed = 1.0 ms/Div The Notch filter is typically not used during AEP recordings and should remain OFF.
  • Page 68 2 Channel Impedance window. 3-12 Channel Impedance window. 2 Channel Amplifier: The impedance values for the Active (-) and Reference (+) inputs are displayed for each channel as well as the Ground electrode. If a Channel is turned Off, no impedance values will be calculated for either the active or reference inputs and the word "Off"...
  • Page 69 Apply the stimulator (headphones or inserts) to the patient, the red headphone/insert should be placed on the patient's right side, the blue headphone/insert should be placed on the left. Connect the stimulator to the back of the Sierra Summit base unit. AEP Stimulator Settings - Controls Window...
  • Page 70 See the AEP Test Setup help topic for more information. • Trigger In (1 - 4) - select Trigger In 1-4 to set the Sierra Summit to trigger the sweep on the positive or negative going edge of an applied external TTL signal. See the AEP Test Setup help topic for more information.
  • Page 71 Rep Rate: Click here to set the repetitive stimulus rate, in pulses per second (Hz). This setting only applies when delivering repetitive stimulation. It does not apply during manual single stimulus delivery. 6. Determine Behavioral Threshold Levels (optional) There is one specially designated knob for setting the behavioral threshold levels. Knob #2 (L or R Thresh / Off).
  • Page 72 You can check the Amp Gain setting by pressing the F1 (Avg / Live) function key to switch to the Live mode. Press the function key again to return to the Avg mode and view the Display Gain setting. 8. Acquire Responses A.
  • Page 73 F. Repeat steps A - D and collect data for the opposite side. Example 2 Channel AEP, Left and Right. 9. Trace Positioning (optional) If the position of the traces needs to be adjusted, follow one of these procedures. • Using the Mouse - simply click on the Trace you want to move with the left mouse button and drag the trace to its new location.

  • Page 74: Vep Operation

    CRT monitors, and as such a compensatory delay (or offset) has to be determined and entered into the Sierra Summit program before an LCD monitor can be used. Without this delay value entered into the program the latency of the visual evoked...
  • Page 75 Determine the number of channels that will be recorded and the electrodes that will be required for each channel. Apply the recording electrodes and ground electrode to the patient and connect to the Sierra Summit amplifier. With the 2 Channel Amplifier, if the same electrode is used as the reference in each channel, use a Reference Jumper to connect this electrode into both reference (+) inputs on the amplifier.
  • Page 76 3. Check Impedances Click on the Impedance Icon in the Toolbar Controls at the top of the screen. The impedance window displays a picture of the front of the amplifier. Impedance Icon 2 Channel Impedance window. 3-12 Channel Impedance window. 2 Channel Amplifier: The impedance values for the Active (-) and Reference (+) inputs are displayed for each channel as well as the Ground electrode.
  • Page 77 See the VEP Test Setup help topic for more information. • Trigger In (1 - 4) - select Trigger In 1-4 to set the Sierra Summit to trigger the sweep on the positive or negative going edge of an applied external TTL signal. See the VEP Test Setup help topic for more information.
  • Page 78 6. Verify Averager Settings Shutoff - This is the number of responses that will be averaged together to produce the final results. When the shutoff count is reached stimulation will automatically be stopped. Reject On / Off - When this feature is turned On the program will monitor the Live un-averaged data and will not include (i.e., will reject) high amplitude artifacts from the running average.
  • Page 79 7. Acquire Responses A. Start Data Acquisition. Press the Run/Stop key to start stimulus delivery and data acquisition. The average count (AvgCnt) should start to increment and the traces will begin to take shape. Adjust the vertical size of the all traces by turning Knob #3 (Gain). To adjust the gain of an individual trace, change the corresponding gain setting in the Toolbar Controls.
  • Page 80 8. Trace Positioning (optional) If the position of the traces needs to be adjusted, follow one of these procedures. • Using the Mouse - simply click on the Trace you want to move with the left mouse button and drag the trace to its new location. •...

  • Page 81: Operation Of Other Test Protocols

    Portable and Mobile RF communications equipment can affect medical electrical equipment. Sierra Summit should not be used adjacent to or stacked with any other equipment. If adjacent or stacked use is necessary, performance of the Sierra Summit should be observed to verify normal operation in the configuration in which it will be used.
  • Page 82 If there are any questions regarding the operation of the Sierra Summit EMG/EP system, contact Cadwell. The Help Topics provide an operational summary for the Sierra Summit system. It does not provide clinical training. It is assumed that the user has adequate clinical training to perform procedures.

  • Page 83: Hazardous Operating Conditions

    Transport and Storage Limits (ambient conditions) The Sierra Summit system should be stored in a clean, dry place. Handle the system with care. Temperature: Do not expose to temperatures below -20º C (-4º F) or above 65º C (149º F)

  • Page 84: Symbols

    Equipotentiality IEC 60417-5021 Type BF equipment. Isolated patient connection. IEC 60417-5333 Output IEC 60417-5035 Input IEC 60417-5034 Audio transducer connection. IEC 60417-5077, Cadwell convention LED Goggles connection. Cadwell convention USB 2.0 symbol KEMA Medical, ISO 7000-3650 Amplifier Symbol Cadwell convention...
  • Page 85 Negative polarity (inverting amplifier input) IEC 60417-5006 Positive polarity (non-inverting amplifier input) IEC 60417-5005 Isolated patient ground input. Cadwell convention Temperature Probe ISO 7000-0034 Audible sound is heard when circuit is closed. Cadwell convention Variability, for rotating movement. Turn IEC 60417-1364 clockwise to increase.

  • Page 86: Date Of Manufacture

    Recycle or dispose of equipment according to regulatory requirements of your country. Manufacturer MDD, EN 980 For prescription use only. Cadwell Convention Fragile Medical Equipment Do Not Drop Cadwell Convention (Device Packaging) Humidity Range ISO 7000- 0505,...

  • Page 87: Electrical Stimulator Characteristics

    Electrical Stimulator Characteristics The Sierra Summit includes one constant-current electrical stimulator, a second electrical stimulator can be added as an option. The output generated can be either monopolar or bipolar (biphasic). The maximum outputs (which cannot occur simultaneously) are: 400 volts...
  • Page 88 If the specified current cannot be delivered, a “Z” symbol appears on the screen for approximately 1 second each time the stimulator is fired. If more current is delivered than was requested, an "Over Current Error" message will be displayed and stimulation will be stopped.

  • Page 90: Electrode Current Densities

    Electrode Current Densities Current Density Graph for EMG Needle Current Density Graph for EEG Needle...
  • Page 91 Current Density Graph for Bar Electrode Current Density Graph for Disposable Bar Electrode...

  • Page 92: Recommended Stimulating Electrodes

    Current Density Graph for Felt-Pad Bar Electrode Recommended Stimulating Electrodes The following Cadwell electrodes (or their equivalent) are recommended for use as stimulating electrodes: Cadwell Stainless Steel Electrical Stimulator Probes • Straight, round head, 6.35 mm diameter. (339073-200) • Straight, round head, 4.75 mm diameter. (339080-200) •...

  • Page 93: Maintenance

    While the Sierra Summit EMG/EP system has been carefully designed and manufactured to be as reliable and durable as possible, regular inspection of the system components can help ensure the long-term trouble-free operation of the system.

  • Page 94: Specifications, Operating Environment & Limits

    Isolation Transformer: 197205-200 Medical Grade Power Strip: 291228-000 Use of accessories and cabling other than those specified in above, with the exception of those sold by Cadwell as replacement parts, may result in increased emissions or decreased immunity of Sierra Summit systems.
  • Page 95 Sierra Summit Electromagnetic Disturbances Compliance Summary Standard/Specification: IEC 60601-1-2:2014 Test Procedure Description Modifications Results IEC 60601-1-2 (CISPR 11), Class A Conducted Emissions Pass IEC 60601-1-2 (CISPR 11), Class A Radiated Emissions Pass IEC 61000-3-2 (2005) + A1+A2 Harmonic Emissions Pass...
  • Page 96 IEC 61000-3-3 emissions above the limit. Sierra Summit should not be used adjacent to or stacked with any other equipment. If adjacent or stacked use is necessary, performance of the Sierra Summit should be observed to verify normal operation in the configuration in which it will be used.
  • Page 97 Surge ±2 kV common Surges may cause events in the display IEC 61000-4-5 mode waveforms. This is an unavoidable phenomenon due to the high input sensitivity of the equipment. These waveform disturbances can be differentiated from physiological events. To minimize these effects, mains power quality should be that of a typical of a professional healthcare environment.
  • Page 98 NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. NOTE 3 Stated separation distances will assure safe operation of the Sierra Summit. However, some noise may present on displayed waveforms.

  • Page 99: Cleaning And Disinfection

    Perform cleaning and disinfection procedures on a periodic basis to ensure the safe operation of your Sierra Summit system. As you clean, visually inspect the instrument and its components for damage or wear. Contact Cadwell if you notice damage to the exterior of the instrument. Do not attempt to service or repair damaged or inoperable equipment.
  • Page 100 Visually inspect the stimulator for unusual wear or damage prior to each use. If you notice damage, disconnect the stimulator immediately and contact Cadwell. Use a soft cloth to clean stimulator parts that come in contact with the patient after each use (e.g., electrical stimulator probes, auditory headphones, insert earphones, bone transducer, and LED Goggles).
  • Page 101 Certain cleaning or disinfecting agents may have a degrading effect on your equipment. Consult your facility's infection control policies in selecting the appropriate disinfection products. Non-corrosive disinfecting agents are preferred. The Summit Stimulator may be disinfected with an intermediate-level surface disinfectant, but certain cleaning agents may have a degrading effect on your equipment.
  • Page 102 For any electrodes not manufactured by Cadwell, follow the manufacturers recommended cleaning procedure first. For any electrodes manufactured by Cadwell, follow the cleaning instructions sent with the electrodes. The following maintenance procedures apply to nonspecialized electrodes: • Electrode preparation and application should be supervised by a qualified healthcare professional.

  • Page 103: Disposal

    Properly discard disposable electrodes after each use (e.g., disposable needle electrodes and disposable surface electrodes). • Cadwell is not responsible for injury, infection, or other damage resulting from improper storage, preparation, use, or disposal of electrodes. Specialized electrodes are often more complex and require special care. Anyone using them should consult the manufacturer for proper maintenance and handling techniques.

  • Page 104: Customer Support

    Remote Assistance: Remote assistance and troubleshooting is available for systems under warranty or service contract. With your permission, a support technician can establish a secure connection to your Cadwell instrument via the internet. Please call the service department or application support department. A support or service technician will verify your account information and guide you through the steps to begin a remote assistance session.

  • Page 105: Warranty Information

    Service at www.cadwell.com/terms. Electrode Catalog and eStore Cadwell has an online electrodes catalog and an eStore to offer competitive pricing, incredible customer service, same day shipping (for orders placed before 2pm Pacific), and the online e-store for a 24/7 shopping convenience.
  • Page 107 (800) 245-3001 · (509) 735-6481 ph · (509) 783-6503 PN# 190272-639 Rev.04...

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