NC‐stat DPNCheck User Manual Rev G

2 NC-stat DPNCheck Device User Manual 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        

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 thoroughly Use the device only as described in this manual Failure to follow the Warnings listed below may cause injury to the patient or operator 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 unless specialist medical opinion has first been obtained Avoid accidental contact with connected but unapplied conductive components, including electrodes 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.



LCD Display – area where test results and error messages are displayed.



LED Light – status indicator.



Battery Compartment – holds 3V Lithium battery that powers device.



Biosensor Port – where the biosensor is connected to the device.



Infrared Thermometer – reads the patient’s skin surface temperature.



Stimulating Probes – non-invasively deliver electrical stimulation to the sural nerve.



Biosensor – a single patient-use biosensor is needed to conduct each test.



USB Port – for communication with a PC.

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3 NC-stat DPNCheck Device User Manual

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4 NC-stat DPNCheck Device User Manual CHAPTER TWO: SETUP 2.1 Package Contents Prior to use, the package should be inspected to ensure that all of the following components are included and undamaged. STANDARD COMPONENTS:  NC-stat DPNCheck device  3V Lithium Battery  USB Cable 2.2 Reporting Damage If any of the components appear to be damaged, or if the NC-stat DPNCheck device fails to operate as described in this manual, contact NeuroMetrix immediately. Within the USA, customers should contact NeuroMetrix Customer Service: Phone: (888) 786-7287 Fax: (781) 663-3820 E-mail: [email protected] International customers should contact the nearest authorized NeuroMetrix representative. If the shipping container is damaged, customers should also notify the shipping carrier. 2.3 Battery Installation The NC-stat DPNCheck device uses a standard 3V Lithium Ion Battery (Type CR123A). 1. Remove the battery cover on the backside of the device. 2. Insert the battery. Check the battery symbol inside the device to ensure proper orientation of positive and negative contacts. 3. Replace the cover. 2.4 Registration In order to activate your warranty, receive software updates, and use various optional reporting and data management services, you must register your device with NeuroMetrix. Call NeuroMetrix Customer Service (888) 786-7287 to register the device’s serial number. The serial number is an 8 digit number (e.g., 11110001) found inside the battery compartment.

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5 NC-stat DPNCheck Device User Manual CHAPTER THREE: OPERATING INSTRUCTIONS This chapter explains the basic operation of the NC-stat DPNCheck device. 3.1 Power On To power on the device, press the grey button under the LCD Display Screen. The green light will blink once to indicate power on and

indicates that the device is ready for use.

3.2 Power Off The device will power off automatically after 10 minutes of inactivity. Note: Your last test is saved on the device until a new test is performed. 3.3 Battery Lifetime The NC-stat DPNCheck is powered by a 3V Lithium Ion Battery. A solid amber light will indicate that the battery is low and should be replaced as soon as you complete the test in progress. A solid red light accompanied by indicates that the battery must be replaced before any further testing. See section 2.3 for battery installation. 3.4 Test Procedure Proper patient positioning, skin preparation, and device placement are essential to accurately administer the test. The section below will demonstrate proper techniques.

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Patient Positioning The preferred position is for the patient to lie on their side on an exam table with the leg to be tested on top (Figure 1). If you cannot see both the outer ankle bone and the calf midline (Achilles tendon), adjust patient position to their appropriate side. The patient should be in a comfortable position that allows for relaxation of the leg and foot. It is important that the patient remains relaxed during the test. Alternative positions may include: side with left leg extended (Figure 2); prone with feet hanging off the exam table (Figure 3); and chair with one leg resting on a chair (Figure 4). The patient should bend their knee and place half of their calf on to the seat in order for the leg to be properly rested and grasp the back of the chair for stability. It is recommended that a sturdy chair with no wheels and a padded seat be used for patient comfort. Note: Users should only use a chair when an exam table is not available.

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8 NC-stat DPNCheck Device User Manual

3.5 Test Results When the test is complete, the device display will toggle between the sural nerve conduction amplitude in microvolts (µV) and the conduction velocity in meters per second (m/s). In cases where the patient has low amplitude (between 2-4 µV) and the CV cannot reliably be reported, only the amplitude will display on the device. Amplitude result is indicated by a decimal point at the upper right corner of the screen.

Recalling Results on Device If the device powers down after a test, the results of that test can be recalled. To recall the results press and hold the button for 3 seconds and you will see the results appear on the display. Results will display for 10 seconds and then the device will power off. This mode can only be accessed when the device is powered off. If you have powered on the device and need to recall the last result, wait 3 minutes for the device to power down and then follow the instructions above for recalling results.

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9 NC-stat DPNCheck Device User Manual 3.6 Recommended Testing Protocol This protocol is intended only as a guide. It is the responsibility of the provider to determine the clinical necessity of nerve conduction testing. Testing a single leg is usually clinically sufficient.  Whenever possible, the same leg should be tested first in all patients. If the first test does not provide a result or to confirm the result, the test should be repeated.  Pressing the test button again is usually all that is required (see Appendix F). The test will provide a nerve conduction result the first time in most patients. Tip: In certain circumstances it may be beneficial to confirm the results. Examples include: - Confirm CV if amplitude is ≤4 μV - Confirm undetectable response - Confirm result inconsistent with clinical findings - If the leg setting on the device was incorrect, then the test should be repeated If the repeat test does not provide a result or for further confirmation of the results the opposite leg should be tested.  The same biosensor may be used on both legs.

Note: The NC-stat DPNCheck device should only be used with NeuroMetrix single patient use biosensors. Repeat use of the same biosensor on multiple patients will disable the device as indicated by the “Ub” error code. Disabled devices must be returned to NeuroMetrix for a factory reset. Users will be required to pay a service fee and all shipping and handling charges.

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10 NC-stat DPNCheck Device User Manual CHAPTER FOUR: SAFETY, WARRANTY SERVICE, CARE, AND SERVICE 4.1 Safety Notes Do not immerse any portion of the NC-stat DPNCheck device in water or other fluids. Avoid spilling fluids on the Device or accessories. Spilling fluids may damage the device and/or present a fire or shock hazard. Possible hazard of fire or explosion. Use care when operating this device close to oxygen sources, flammable gases, and chemicals. Failure to follow the Cautions listed below may change the performance of the equipment, or cause damage to the equipment. Radio frequency (RF) interference from devices such as cellular phones and two-way radios may cause improper operation of the NC-stat DPNCheck device if used in close proximity. Accessory equipment connected to the USB port must be certified according to the respective IEC standards (e.g. IEC60950 for data processing equipment and IEC60601-1 for medical equipment). Most computers manufactured by major suppliers meet the IEC60950 standard. If in doubt, consult your local Information Technology support. 4.2 Maintenance and Cleaning Other than changing the battery, there are no user serviceable parts inside the NC-stat DPNCheck device. Refer to the warranty and service information included in this manual. The NC-stat DPNCheck device has been manufactured to the highest quality standards. To ensure continued trouble-free operation, avoid exposing the components to excessive shock, vibration, or moisture. Cleaning the device and any components:  Remove the battery and close the battery compartment and any other external connections before cleaning the Device or any of the components.  Use a soft damp cloth or sponge to clean the exterior of the unit.  Do not use abrasive cleaners or strong solvents to clean the device. Disinfecting the NC-stat DPNCheck device:  If the NC-stat DPNCheck device becomes contaminated by body fluids, it should be cleaned using a hospital grade disinfectant and a disposable, soft cloth or paper towel, per standard hospital or office protocol. 4.3 Use of and Disposal of Batteries The battery is a 3.0V Lithium Battery type CR123A. Dispose of used Lithium battery in accordance with national, regional, and local regulations.

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11 NC-stat DPNCheck Device User Manual 4.4 Storage of Biosensors NC-stat DPNCheck biosensors are single-use, non-sterile devices. They should be stored lying flat at room temperature in a dry location. Storage temperature should not fall below -22° F (-30° C) or exceed 140° F (60° C). The package should only be opened immediately prior to use. The biosensors should not be used after the expiration date shown on the package. 4.5 NeuroMetrix, Inc. Limited One Year Warranty NeuroMetrix, Inc. manufactures its hardware products from new components in accordance with industry standard practices. NeuroMetrix warrants the NC-stat DPNCheck device 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. Damage due to shipping the products is covered under this warranty. Otherwise, this warranty does not cover damage due to external causes, including accident, abuse, misuse, problems with electrical power, servicing not authorized by NeuroMetrix, Inc., usage not in accordance with product instructions, failure to perform required preventive maintenance, and problems caused by use of parts and components not supplied by NeuroMetrix, Inc. This warranty does not cover any items that are in one or more of the following categories: software, external devices (except as specifically noted) or accessories or parts added to a NeuroMetrix device through authorized NeuroMetrix service centers. NeuroMetrix, Inc., will repair or replace products covered under this limited warranty that are returned to NeuroMetrix’s facility or an authorized NeuroMetrix representative. To request warranty service, you must call the NeuroMetrix Customer Service at (888) 786-7287 or call an authorized technical support representative within the warranty period. NeuroMetrix will issue a Return Material Authorization (RMA) Number. The product must be shipped to NeuroMetrix in the original or equivalent packaging, with prepaid shipping charges, and insured against loss or damage during shipment. NeuroMetrix will ship the repaired or replacement units to the originator (freight prepaid) to addresses within the US or Canada. Shipments to other locations will be made freight collect. All parts removed from repaired products will become the property of NeuroMetrix, Inc. If NeuroMetrix repairs or replaces a product, the original warranty is not extended. NEUROMETRIX, INC. MAKES NO EXPRESS WARRANTIES OR CONDITIONS BEYOND THOSE STATED IN THIS WARRANTY STATEMENT. NEUROMETRIX DISCLAIMS ALL OTHER WARRANTIES AND CONDITIONS, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION IMPLIED WARRANTIES AND CONDITIONS OR MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. SOME STATES (OR JURISDICTIONS) DO NOT ALLOW LIMITATIONS ON IMPLIED WARRANTIES OR CONDITIONS, SO THIS LIMITATION MAY NOT APPLY TO YOU. NEUROMETRIX’S RESPONSIBILITY FOR MALFUNCTIONS AND DEFECTS IN HARDWARE IS LIMITED TO REPAIR AND REPLACEMENT AS SET FORTH IN THIS WARRANTY STATEMENT. THESE WARRANTIES GIVE YOU SPECIFIC LEGAL RIGHTS IN ADDITION TO OTHER RIGHTS WHICH VARY FROM STATE TO STATE.

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12 NC-stat DPNCheck Device User Manual NEUROMETRIX INC. DOES NOT ACCEPT LIABILITY BEYOND THE REMEDIES SET FORTH IN THIS WARRANTY STATEMENT OR LIABILITY FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING WITHOUT LIMITATION ANY LIABILITY FOR PRODUCTS NOT BEING AVAILABLE FOR USE OR FOR LOST DATA OR SOFTWARE. These provisions apply to NeuroMetrix’s limited one-year warranty only. 4.6 Service Should the NC-stat DPNCheck device require service, contact NeuroMetrix Customer Service at (888) 786-7287. When you call NeuroMetrix to request service, please be prepared to provide the following information:  Serial number  Description of the problem Do not return any component of the NC-stat DPNCheck device without first obtaining a Return Material Authorization (RMA) Number from Customer Service. Be sure that this number is clearly visible on the exterior of the return package. If a NC-stat DPNCheck device component must be shipped to a service center, pack it in the original shipping container or in packaging which provides enough protection to prevent damage during shipment. 4.7 FDA Notification The NC-stat DPNCheck device is manufactured in compliance with the U.S. Federal Quality System Regulation (21 CFR Part 820). As a health care provider, you may have responsibilities under the Safe Medical Devices Act (SMDA) for reporting to NeuroMetrix, and possibly the FDA, the occurrence of certain events. (FDA reportable events are detailed in 21 CFR Part 803.) In accordance with our Quality System, NeuroMetrix should be notified of any device failures or malfunctions. Issues encountered should be reported to NeuroMetrix Customer Service. Outside of the United States, problems should be reported to the nearest NC-stat DPNCheck device distributor. This information will help ensure that NeuroMetrix continues to provide products and services of the highest possible quality.

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13 NC-stat DPNCheck Device User Manual Appendix A: SPECIFICATIONS Dimensions Device Size Weight

5.5 cm x 19.0 cm x 11.6 cm 160 g

Environmental - Shipping and Storage Temperature Humidity Altitude Operating

-20 °C to 50 °C 10% to 90%, non-condensing 55 kPa to 100 kPa 10 °C to 30°C

Hardware Channels CMRR (typical) Gain Noise (typical) Frequency Response Sampling Frequency ADC Resolution Stimulator Type Constant Current Stimulator Max Voltage (typical) Stimulator Max Current Stimulator Pulse Width Stimulation Frequency Skin Temperature Measurement Battery LCD Display Water Resistance Classification Type

2 ≥ 100 dB x977 < 2 μV rms (-3 dB) 2 Hz – 2 kHz 10 kHz 16 bits (effective) Monophasic 420 V 100 mA hardware, software limited to 70 mA 100 μs 1 Hz (maximum) Non-contact, infrared 3.0 V Lithium Primary (CR123A) 2 digit, 7-segment IEC 529 IPX0 not protected from ingress of liquids BF Applied Part, IEC 60601-1

Neurophysiology Nerve Methodology Stimulation Site Stimulation Configuration Recording Site Recording Configuration Conduction Velocity (CV) Response Amplitude Temperature Compensation Method Reference Temperature

Sural sensory, orthodromic Preconfigured electrode array Behind lateral malleoulus Bipolar (2 cm separation) 9.22 cm proximal to stimulation Bipolar (2 cm separation) Onset of negative deflection (m/s) Peak to peak (μV) Linear, 1.0 m/s per degree, maximum correction 5 m/s 28 oC

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14 NC-stat DPNCheck Device User Manual Appendix B: SYMBOLS

Attention/User Manual/device labeling

Type BF Applied Part

Mark identifying compliance with council directive 93/42/EEC 0123 is the I

Identification mark of the Notified Body, TUV SÜD

0123

responsible for evaluation of the CE Technical File.

WEEE (Waste Electronic and Electrical Equipment) symbol in accordance with council directive 2002/96/EC

MN

Abbreviation for model number

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15 NC-stat DPNCheck Device User Manual Appendix C: SENSORY NERVE CONDUCTION PRINCIPLES & NERVE CONDUCTION TERMINOLOGY

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16 NC-stat DPNCheck Device User Manual Appendix D: USB CONNECTION Uploading Data The most recent test results may be uploaded to your PC using a USB cable. A mini-USB port is located on the side of the device. The device can only retain data from a single test. Users must upload the data after each test for report generation. Note: If the device powers off before performing an upload, the data is still saved on the device and may be uploaded. 1. Power on the device. 2. Open the USB port located on the side of the device. 3. Ensure that the Communicator application is open on the PC. 4. Connect the USB cable to the device and PC. 5. After connecting the device to the PC with the USB cable, the device LCD screen will display PC. Note: If the red light on the device appears during this step, the data could not be transferred. See Appendix F for Troubleshooting.

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17 NC-stat DPNCheck Device User Manual Appendix E: TEMPERATURE COMPENSATION Nerve conduction measurements may be sensitive to the temperature around the nerve, which in superficially located nerves (e.g., sural), may be different than body temperature. Nerve temperature is usually approximated by the skin surface temperature overlying the nerve. The NC-stat DPNCheck device compensates for the effect of temperature on sural nerve conduction velocity using a linear temperature compensation factor of 1 m/s per oC with a reference temperature of 28 oC. The effect of temperature on sural nerve conduction amplitude is small and therefore compensation is not applied for this parameter. The temperature is measured by an infrared thermometer, located at the base of the handle behind the stimulating probes. If the temperature is below 23 oC, then the patient is too cold to reliably measure nerve conduction and the test will stop with

displayed on the LCD screen.

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18 NC-stat DPNCheck Device User Manual Appendix F: TROUBLESHOOTING

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19 NC-stat DPNCheck Device User Manual Appendix G: MANUFACTURER’S DECLARATIONS OF CONFORMITY (in accordance with ISO/IEC 17050-1 and ZLG 3.9 A 4) MANUFACTURER NeuroMetrix, Inc 62 Fourth Avenue Waltham, MA 02451 USA Object of the declaration: NC-stat DPNCheck Catalog Number:

NC-030, NC-DP1, NC-DP2

Under the sole responsibility of NeuroMetrix, Inc., the object(s) of the declaration described above is in conformity with the requirements of the following documents: Medical Device Directive 93/42/EEC: Annex II – NC-030 Annex VII – NC-DP1, NC-DP2

European Authorized Representative: EMERGO Europe Molenstraat 15 2513 BH, The Hague The Netherlands Notified Body: (Annex II Products Only) TüV SüD Product Service GmbH Notified Body Number 0123 Zertifizierstelle Ridlerstasse 65 80339 Munchen Germany Date of First CE Marking: September 1, 2011 (NC-030, NC-DP1), September 11, 2012 (NC-DP2) Signed for and on behalf of NeuroMetrix, Inc.

Rainer Maas Director of QA/RA/Compliance Waltham, MA 02451 USA

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20 NC-stat DPNCheck Device User Manual Appendix H: ELECTROMAGNETIC COMPATIBILITY DECLARATION

NC-stat DPNCheck 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; CISPR 11

Group 1

NC-stat DPNCheck uses RF energy only for its internal function. Its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions; CISPR 11

Class B

NC-stat DPNCheck is suitable for use in all establishments, including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.

Electrostatic Discharge Immunity (ESD); IEC 61000-4-2

±6kV contact; ±8kV air

Floors should be wood, concrete or ceramic tile.

Radiated RF; IEC 61000-4-3

3 V/m; 80 MHz to 2.5 GHz

3 V/m compliance level

Magnetic Fields; IEC61000-4-8

3 A/m

3 A/m compliance level

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