CHAPTER ONE: INTRODUCTION
1.1 Indications For Use
The NeuroMetrix NC-stat®|DPNCheck™ is intended to measure neuromuscular signals that are
useful in diagnosing and evaluating systemic and entrapment neuropathies.
1.2 Contraindications
None.
1.3 Warnings, Precautions & Safety Considerations
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Federal law restricts this device to sale or use by or on the order of a health care provider
appropriately licensed by the law in the state in which they practice
For safe and effective operation of the device, please read and understand the User Manual
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thoroughly
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Use the device only as described in this manual
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Failure to follow the Warnings listed below may cause injury to the patient or operator
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Possible hazard of fire or explosion. Use care when operating this device close to oxygen
sources, flammable gases, and chemicals
Patients with implanted electronic devices should not be subjected to electrical stimulation
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unless specialist medical opinion has first been obtained
Avoid accidental contact with connected but unapplied conductive components, including
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electrodes
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Do not place any part of the device over broken skin, lesions, or wounds
1.4 Overview
The NC-stat DPNCheck device measures the sural nerve conduction velocity and sensory nerve action
potential (SNAP) amplitude. The device includes the following elements:
Power/Test Button – allows users to turn the device on and initiate a test.
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LCD Display – area where test results and error messages are displayed.
LED Light – status indicator.
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Battery Compartment – holds 3V Lithium battery that powers device.
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Biosensor Port – where the biosensor is connected to the device.
Infrared Thermometer – reads the patient's skin surface temperature.
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Stimulating Probes – non-invasively deliver electrical stimulation to the sural nerve.
Biosensor – a single patient-use biosensor is needed to conduct each test.
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USB Port – for communication with a PC.
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NC-stat DPNCheck Device User Manual
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