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NeuroMetrix ASCEND User Manual

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NeuroMetrix
ASCEND
User's Manual
DRAFT
Page 1 of 32

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Summary of Contents for NeuroMetrix ASCEND

  • Page 1 NeuroMetrix ASCEND User’s Manual DRAFT Page 1 of 32...
  • Page 2 NeuroMetrix, Inc. is under license. Part Number: PN 2202661 Rev. X16 Protected by US and international patents pending. CAUTION: Federal law restricts the use of output of ASCEND to a physician or other properly licensed practitioner. DRAFT Page 2 of 32...

  • Page 3: Table Of Contents

    Table of Contents Chapter One – Indications for Use, Principles of Operation, ASCEND Description 4 Indications for use Contraindications Nerve Stimulation: Overview Nerve Stimulation: Principles of Operation ASCEND Description Chapter Two – Preparing ASCEND for Use Overview Cradle Setup Stimulator Setup Registration Chapter Three –...

  • Page 4: Chapter One - Indications For Use, Principles Of Operation, Ascend Description

    CHAPTER ONE Indications for Use, Principle of Operations, ASCEND Description This manual is intended for users of the NeuroMetrix ASCEND Peripheral Nerve Stimulator (“ASCEND”). Indications For Use NeuroMetrix ASCEND is a peripheral nerve stimulator used for localization and verification of needle placement for perineural application of pharmacological agents.
  • Page 5 membrane potential to about 55 mV, making the membrane freely permeable and generating an action potential. The various types of nerve fiber differ with regard to their sensitivity to electrical stimulation. The Aα motor fibers have the shortest chronaxia (50–100 μs). The afferent fibers that transmit pain sensation (Aδ...

  • Page 6: Ascend Description

    ASCEND Description ASCEND is a battery powered nerve stimulator for localization of peripheral nerves. It is comprised of the following components. 1. Stimulator The Stimulator includes the electronic circuits that provide electrical nerve stimulation, user controls which include a stimulation current magnitude control and function buttons that...
  • Page 7 NeuroMetrix. These needles typically serve as the stimulation cathode. 2. Surface Electrodes (“Electrodes”) ASCEND utilizes a disposable tab surface electrode as the stimulation anode. ASCEND can be used with any suitable disposable surface electrode. Figure 4 DRAFT Page 7 of 32...

  • Page 8: Chapter Two - Preparing Ascend For Use

    Preparing ASCEND for Use Overview Prior to use, the ASCEND Stimulator, Cradle, and other packaged components should be inspected to ensure that they have not been damaged in shipping. If damage is encountered, or if any component fails to operate as described in this manual, contact NeuroMetrix Customer Service immediately.

  • Page 9: Registration

    Registration NeuroMetrix Customer Service will register your system at the time of installation. DRAFT Page 9 of 32...

  • Page 10: Chapter Three - User Interface And Controls

    CHAPTER THREE User Interface and Controls Overview This section describes the Stimulator User Interface. Physical buttons are indicated in bold blue. On screen buttons, which are activated by tapping the touch screen with the stylus, are indicated in bold green. On screen messages are indicated in orange. Control Buttons –...
  • Page 11 1000 µsec may be selected. The third button starts and stops stimulation. The bottom button is reserved for future use. Figure 7 – Patient Stimulation Current Indicator The patient stimulation current indicator (Figure 7, red rectangle) shows the current delivered to the patient.
  • Page 12 • Orange, when the patient current is equal to or less than the threshold current and is within the tolerance of the target current. • Red when the patient current is out of the tolerance of the target current. • Gray and steady when no stimulus is being delivered.
  • Page 13 This bottom right corner of the screen (Figure 10, red rectangle) shows the battery fuel gauge and the back arrow to return the operator to the main screen. DRAFT Page 13 of 32...

  • Page 14: Chapter Four - Device Description

    Overview This chapter describes basic operation of ASCEND. The operator should verify that all ASCEND components are in a serviceable condition before each use. Defective components should not be used. The equipment may only be repaired by NeuroMetrix. Please contact customer service at 1-888-786-7287 if you have any concerns regarding the device.

  • Page 15: Stimulation Duration

    Stimulus Duration The stimulus duration is set by pressing the button. Each time this button is DURATION pressed it will change the duration to the next value in the following repeating sequence: 50 μsec, 100 μsec, 200 μsec, 500 μsec, 1000 μsec. On power up the duration is set to 100 μsec. Stimulation Frequency The stimulation frequency is set by pressing the button.

  • Page 16: Chapter Five - Device Checks

    “Stim Aborted Code: 0x0021” error message displayed. In the event of this error, the user should recharge the battery. If the same error message occurs following battery recharging, contact NeuroMetrix Customer Service to arrange for device servicing. Stimulation Circuitry Check The device performs a power-up self-check on the stimulation circuitry by delivering a stimulus to an internal resistor (10 kOhm).

  • Page 17: Appendix A - Warranty, Service, Care And Device Registration

    Under no circumstance should the LCD screen be touched with any object other than the supplied stylus. The ASCEND system is designed to be used in a clinical environment. Proper care should be used when maintaining these components. Inspect all parts for any visible damage. Never use...
  • Page 18 NeuroMetrix, Inc. manufactures its hardware products from new components in accordance with industry standard practices. NeuroMetrix, Inc. warrants the ASCEND System to be free from defects in materials and workmanship. The warranty term is one year beginning on the date of invoice, as described in the following text.

  • Page 19: Device Registration

    Issues encountered should be reported to NeuroMetrix Customer Service at (888) 786-7287. Outside of the United States, device issues should be reported to the nearest ASCEND distributor. This information will help ensure that NeuroMetrix continues to provide products and service of the highest possible quality.

  • Page 20: Service

    Authorization (RMA) number from Customer Service. Be sure the RMA number is clearly visible on the exterior of the return package. If an ASCEND component must be shipped to a service center, pack it in the original shipping container or with sufficient protective packing to prevent damage during shipment.
  • Page 21 Licensor grants the User a license to use the Software and any associated documentation for the User’s personal use or internal business or professional purposes solely as intended to operate and use the ASCEND, and solely as installed on and/or provided with the ASCEND purchased from Licensor or its authorized distributor or reseller, consistent with the terms of this Agreement.
  • Page 22 LICENSOR DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE OR NONINFRINGEMENT OF THIRD PARTIES’ INTELLECTUAL PROPERTY RIGHTS. 7. Limitation of Liability. In no event will Licensor be liable for personal injury, or any damages including lost profits or other incidental, special, punitive, exemplary, direct, indirect or consequential damages, arising out of or related to the Software, documentation or the use or misuse thereof, even if Licensor has been advised, or is otherwise aware, of the possibility of such damages and even if the warranty remedy of Section 6 fails of its essential purpose.

  • Page 23: Appendix B - Error Messages, Warnings And Cautions

    APPENDIX B Error Messages, Warnings and Cautions Error Messages Battery Low If the battery capacity falls below 10% remaining a dialog will popup with the following text: "Battery Low! Return to Charger" Battery Empty If the battery capacity falls below 5% remaining a dialog will pop up with the following text: "Battery too Low! Turning Off"...
  • Page 24 HV Protection Error If the user is stimulating a patient and the high voltage circuit experiences an error stimulation will halt and a dialog will pop up with the following text: "Stim aborted Code: 0x0020" HV Undervoltage Error If the user is stimulating a patient and the high voltage circuit voltage is measured below the minimum level, stimulation will halt and a dialog will pop up with the following text: "Stim aborted Code: 0x0021"...
  • Page 25 Station, and the ASCEND device is powered off prior to cleaning. WARNING: Do not immerse any portion of the ASCEND and the Charging Station in water or other fluids. Avoid spilling fluids on ASCEND electrodes. Spilled fluids may damage the device or present a fire or shock hazard.
  • Page 26 WARNING: Only position the Reference Electrodes near the Needle Electrode Stimulation site. WARNING: Ensure the patient’s skin is shaved, degreased, clean and completely dry before applying the Electrode. Poor skin contact can lead to incorrect positioning of the stimulation needle. WARNING: Under occasional circumstances, transient skin irritations may occur after Electrode removal.

  • Page 27: Appendix C - Specifications

    APPENDIX C Specifications Dimensions Size: Stimulator: 3.3” H x 6.0” W x 1.7” D Charger: 3.0” H x 7.2” W x 5.1” D Weight: Device: 10.4 oz. (294.8 g) Charger: 12.0 oz. (340.2 g) Environmental: (Shipping and Storage): Temperature: -30 C to 60 C, 72 hours at each temperature extreme...
  • Page 28 Electrical Stimulator Specifications Stimulator Power Source Lithium-Polymer Battery Line Current Isolation Yes, battery operated Output current range: Constant current 0 – 5 mA, into a 16 kOhm load maximum, controlled by the user Stimulation pulse rise/decay time: Maximum 3 µs with 1 kOhm load Maximum output voltage Vmax: 90V with 10% tolerance...

  • Page 29: Appendix D - Symbols And Acronyms

    APPENDIX D Symbols and Acronyms Symbols Attention/User Manual/device labeling Warning: Shock Hazard Class II, IEC 601-1 Type BF Applied Part Mark identifying compliance with council directive 93/42/EEC 0123 is the identification mark of the Notified Body, TUV SÜD responsible for evaluation of the CE Technical File. 0123 Abbreviation for model number WEEE (Waste Electronic and Electrical Equipment) symbol...
  • Page 30 Acronyms Analog to Digital Conversion ASCEND The brand of the NeuroMetrix Nerve Localization Stimulator Body Float (Type of medical device) Cyclic Redundancy Check Graphic User Interface Liquid Crystal Display Light Emitting Diode Nerve Stimulator Near Nerve Injection Radio Frequency User Interface...

  • Page 31: Appendix E - Accessories

    AS-001 Electrode Needle, Hypodermic, 20G, 150mm RA-20150 Electrode Needle, Hypodermic, 22G, 50mm RA-2250 Electrode Needle, Hypodermic, 22G, 75mm RA-2275 Electrode Needle, Hypodermic, 25G, 50mm RA-2550 Please contact NeuroMetrix customer service at 888-786-7287 to order accessories. DRAFT Page 31 of 32...

  • Page 32: Appendix F - Electromagnetic Compatibility Declaration

    APPENDIX F Electromagnetic Compatibility Declaration ASCEND is intended for use in the electromagnetic environment specified below. The user should ensure that it is used in such an environment. Emissions test Compliance Electromagnetic environment – guidance RF emissions ASCEND uses RF energy for its function. Its RF emissions are...

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