NeuroMetrix NC-stat DPNCheck User manual

40 22 48 0 33 41
NC-stat®
DPNCheck®
User Manual
NEUROMetrix®

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NC-stat DPNCheck Device User Manual
©2021 NeuroMetrix, Inc. All Rights Reserved. PN2203282 Rev N
CHAPTER ONE: INTRODUCTION……………………………………………………………………………………………………….….2
1.1 Indications For Use.................................................................................................................................2
1.2 Contraindications....................................................................................................................................2
1.3 Warnings, Precautions & Safety Considerations.....................................................................................2
1.4 Overview.................................................................................................................................................2
CHAPTER TWO: SETUP..........................................................................................................................4
2.1 Package Contents....................................................................................................................................4
2.2 Reporting Damage..................................................................................................................................4
2.3 Battery Installation……………………………………………………...........................................................................4
2.4 Registration……………………………………………..............................................................................................4
CHAPTER THREE: OPERATING INSTRUCTIONS......................................................................................5
3.1 Power On................................................................................................................................................5
3.2 Power Off................................................................................................................................................5
3.3 Battery Lifetime......................................................................................................................................5
3.4 Test Procedure…………………………………………………………………………………….................................................5
3.5 Test Results.............................................................................................................................................8
3.6 Recommended Testing Protocol.............................................................................................................9
CHAPTER FOUR: SAFETY, MAINTENANCE, AND SERVICE……………………................................................10
4.1 Safety Notes..........................................................................................................................................10
4.2 Maintenance and Cleaning....................................................................................................................10
4.3 Use of and Disposal of Batteries...........................................................................................................10
4.4 Storage of Biosensors............................................................................................................................11
4.5 NeuroMetrix, Inc. Limited One Year Warranty.....................................................................................11
4.6 Service...................................................................................................................................................12
4.7 FDA Notification....................................................................................................................................12
APPENDIX
Appendix A: Specifications.........................................................................................................................13
Appendix B: Symbols..................................................................................................................................14
Appendix C: Sensory Nerve Conduction Principles & Nerve Conduction Terminology…………………………..15
Appendix D: USB Connection……................................................................................................................16
Appendix E: Temperature Compensation..................................................................................................17
Appendix F: Troubleshooting.....................................................................................................................18
Appendix G: Manufacturer’s Declarations of Conformity..........................................................................19
Appendix H: Electromagnetic Compatibility Declaration...........................................................................20

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NC-stat DPNCheck Device User Manual
©2021 NeuroMetrix, Inc. All Rights Reserved. PN2203282 Rev N
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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NC-stat DPNCheck Device User Manual
©2021 NeuroMetrix, Inc. All Rights Reserved. PN2203282 Rev N

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NC-stat DPNCheck Device User Manual
©2021 NeuroMetrix, Inc. All Rights Reserved. PN2203282 Rev N
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: [phone]
Fax: [phone]
E-mail: [e-mail]
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 [phone] 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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NC-stat DPNCheck Device User Manual
©2021 NeuroMetrix, Inc. All Rights Reserved. PN2203282 Rev N
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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NC-stat DPNCheck Device User Manual
©2021 NeuroMetrix, Inc. All Rights Reserved. PN2203282 Rev N
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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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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©2021 NeuroMetrix, Inc. All Rights Reserved. PN2203282 Rev N
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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NC-stat DPNCheck Device User Manual
©2021 NeuroMetrix, Inc. All Rights Reserved. PN2203282 Rev N
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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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 [phone] 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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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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Appendix A: SPECIFICATIONS
Dimensions
Device Size
5.5 cm x 19.0 cm x 11.6 cm
Weight
160 g
Environmental - Shipping and
Storage
Temperature
-20 °C to 50 °C
Humidity
10% to 90%, non-condensing
Altitude
55 kPa to 100 kPa
Operating
10 °C to 30°C
Hardware
Channels
2
CMRR (typical)
≥100 dB
Gain
x977
Noise (typical)
< 2 μV rms
Frequency Response
(-3 dB) 2 Hz – 2 kHz
Sampling Frequency
10 kHz
ADC Resolution
16 bits (effective)
Stimulator Type Constant Current
Monophasic
Stimulator Max Voltage (typical)
420 V
Stimulator Max Current
100 mA hardware, software limited to 70 mA
Stimulator Pulse Width
100 μs
Stimulation Frequency
1 Hz (maximum)
Skin Temperature Measurement
Non-contact, infrared
Battery
3.0 V Lithium Primary (CR123A)
LCD Display
2 digit, 7-segment
Water Resistance
IEC 529 IPX0 not protected from ingress of liquids
Classification Type
BF Applied Part, IEC 60601-1
Neurophysiology
Nerve
Sural sensory, orthodromic
Methodology
Preconfigured electrode array
Stimulation Site
Behind lateral malleoulus
Stimulation Configuration
Bipolar (2 cm separation)
Recording Site
9.22 cm proximal to stimulation
Recording Configuration
Bipolar (2 cm separation)
Conduction Velocity (CV)
Onset of negative deflection (m/s)
Response Amplitude
Peak to peak (μV)
Temperature Compensation Method
Linear, 1.0 m/s per degree, maximum correction 5 m/s
Reference Temperature
28 oC

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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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Appendix C: SENSORY NERVE CONDUCTION PRINCIPLES & NERVE CONDUCTION TERMINOLOGY

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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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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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Appendix F: TROUBLESHOOTING

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Appendix G: MANUFACTURER’S DECLARATIONS OF CONFORMITY
(in accordance with ISO/IEC 17050-1 and ZLG 3.9 A 4)
MANUFACTURER
NeuroMetrix, Inc
4- B Gill Street
Woburn, MA 01801 USA
Object of the declaration: NC-stat DPNCheck Nerve Conduction Velocity Measurement System
Catalog Number: NC-030 (Device), NC-DP1 (Biosensor), NC-DP2 (Biosensor)
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, Class IIa, rule 10
Annex VII – NC-DP1, NC-DP2, Class I, rule 1
European Authorized Representative:
EMERGO Europe
Prinsessegracht 20
2514 AP 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)
Validity: Until expiration of CE Certificate Number G1 16 10 40014 014
Signed for and on behalf of NeuroMetrix, Inc.
Rainer Maas September 16, 2019
Director of QA/RA/Compliance
Woburn, MA 01801 USA