NeuroMetrix DPNCheck NC-040 User manual

User Manual
(Model: NC-040)

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DPNCheck NC-040 Device User Manual
©2022 NeuroMetrix, Inc. All Rights Reserved. PN2205700 Rev A
Table of Contents
Table of Contents .................................................................................................................. 1
CHAPTER 1: INTRODUCTION .................................................................................................. 3
1.1 Indications For Use........................................................................................................................3
1.2 Contraindications..........................................................................................................................3
1.3 Warnings, Precautions & Safety Considerations ..........................................................................3
1.4 Device Overview ...........................................................................................................................4
CHAPTER 2: SETUP................................................................................................................. 5
2.1 Package Contents..........................................................................................................................5
2.2 Reporting Damage ........................................................................................................................5
2.3 Battery Installation........................................................................................................................5
CHAPTER 3: DPNCheck OPERATIONS OVERVIEW AND CONFIGURATION................................. 6
3.1 DPNCheck Operation Overview....................................................................................................6
3.2 Battery Status................................................................................................................................7
3.3 Biosensor Connection Status ........................................................................................................7
3.4 Test Mode Configuration and Device Information .......................................................................8
CHAPTER 4: OPERATING INSTRUCTIONS .............................................................................. 10
4.1 Power On ....................................................................................................................................10
4.2 Power Off....................................................................................................................................10
4.3 Patient Positioning......................................................................................................................11
4.4 Test Procedure............................................................................................................................12
4.5 Test Results Review –Single Limb Results..................................................................................16
4.6 Test Results Review –Results Available for Both Limbs.............................................................18
4.7 Waveform Scaling .......................................................................................................................21
4.8 Recommended Testing Protocol.................................................................................................22

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DPNCheck NC-040 Device User Manual
©2022 NeuroMetrix, Inc. All Rights Reserved. PN2205700 Rev A
CHAPTER 5: SAFETY, WARRANTY SERVICE, CARE, AND SERVICE............................................ 23
5.1 Safety Notes................................................................................................................................23
5.2 Maintenance and Cleaning .........................................................................................................23
5.3 Disposal of Device, Batteries, and Biosensors ............................................................................24
5.4 Storage of Biosensors..................................................................................................................24
5.5 NeuroMetrix, Inc. Limited One Year Warranty...........................................................................24
5.6 Service.........................................................................................................................................25
5.7 FDA Notification..........................................................................................................................25
APPENDIX A: SPECIFICATIONS.............................................................................................. 27
APPENDIX B: SYMBOLS........................................................................................................ 28
APPENDIX C: SENSORY NERVE CONDUCTION PRINCIPLES & NERVE CONDUCTION
TERMINOLOGY.................................................................................................................... 29
APPENDIX D: UPLOAD TEST RESULTS TO COMPUTER ........................................................... 30
APPENDIX E: TEMPERATURE COMPENSATION ..................................................................... 32
APPENDIX F: TROUBLESHOOTING ........................................................................................ 33
APPENDIX G: ELECTROMAGNETIC COMPATIBILITY DECLARATION ........................................ 36

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DPNCheck NC-040 Device User Manual
©2022 NeuroMetrix, Inc. All Rights Reserved. PN2205700 Rev A
CHAPTER 1: INTRODUCTION
1.1 Indications For Use
The NeuroMetrix 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 the instructions for use (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
•Operation in close proximity to a shortwave or microwave therapy equipment may produce
instability.

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DPNCheck NC-040 Device User Manual
©2022 NeuroMetrix, Inc. All Rights Reserved. PN2205700 Rev A
1.4 Device Overview
The 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.
•Touchscreen Display –area selecting and displaying test information and results.
•LED Light –status indicator.
•Battery Compartment –holds 3V Lithium battery (Panasonic model CR123A).
•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 (NeuroMetrix model
NC-DP2).
•USB-C Port –for communication with a PC (optional).

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DPNCheck NC-040 Device User Manual
©2022 NeuroMetrix, Inc. All Rights Reserved. PN2205700 Rev A
CHAPTER 2: SETUP
2.1 Package Contents
Prior to use, the package should be inspected to ensure that all the following components are included
and undamaged.
STANDARD COMPONENTS:
•DPNCheck device, model NC-040
•3V Lithium Battery (Panasonic model CR123A)
•USB C Cable
Your device serial number can be found on the inside of the battery compartment, or from the Device
Information screen (see Section 3.4). Your model number (MN) can be found on the information label
on your device.
2.2 Reporting Damage
If any of the components appear to be damaged, or if theDPNCheck 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 DPNCheck device uses a standard 3V Lithium-Ion Battery (Panasonic type CR123A).
1. Remove the battery compartment cover on the backside of the device (refer to picture on page
4 for the location of the battery compartment).
2. Insert the battery. Check the battery symbol inside the device to ensure proper orientation of
positive and negative contacts.
3. Replace the cover.
Make sure batteries are in good condition before using (i.e., no damage to outer case). When storing
the DPNCheck device for an extended period of time, the battery should be removed prior to storing.

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DPNCheck NC-040 Device User Manual
©2022 NeuroMetrix, Inc. All Rights Reserved. PN2205700 Rev A
CHAPTER 3: DPNCheck OPERATIONS OVERVIEW AND CONFIGURATION
This chapter provides an overview of DPNCheck device operations. To prepare the device for patient
testing, install the correct type of battery into the device (see Section 2.3) and set up the desired Test
Mode (see Section 3.4).
3.1 DPNCheck Operation Overview
The flowchart below illustrates the basic steps for preparing a DPNCheck device and using the device to
perform a test (including an optional step of uploading test results to a compatible PC application).

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DPNCheck NC-040 Device User Manual
©2022 NeuroMetrix, Inc. All Rights Reserved. PN2205700 Rev A
3.2 Battery Status
The DPNCheck is powered by a replaceable 3V Lithium-Ion battery (Panasonic model CR123A). Battery
status is indicated by a battery icon on the lower left corner of the display screen. The following icons
provide information on the battery status:
See Section 2.3 for battery installation.
3.3 Biosensor Connection Status
To perform a DPNCheck test, a biosensor must be connected to the device. On the lower right corner of
the display screen, a biosensor icon provides an indication on whether a biosensor is connected to the
device. The following icons provide information on the biosensor connection status:
Battery is sufficient for testing.
Battery is sufficient for testing but is low and will
need to be replaced soon.
There is not sufficient battery charge to complete a
test.
No biosensor is connected.
Biosensor is connected to the device.

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DPNCheck NC-040 Device User Manual
©2022 NeuroMetrix, Inc. All Rights Reserved. PN2205700 Rev A
3.4 Test Mode Configuration and Device Information
The DPNCheck device can be configured for either Unilateral Mode or Bilateral Mode.
Unilateral Mode:
The device assumes the user is typically testing a single limb on each patient. Only one test can be
stored on the device at a time.
Bilateral Mode:
The device assumes the user is typically testing both limbs and will store two tests, one for each limb.
To set the Test Mode, power on device, ensure no biosensor is connected (see sample screen below, the
biosensor icon on the bottom right corner shows outline only):
Then press and hold the Power/Test button for at least 5 seconds until the following Test Mode screen is
shown. Select the desired test mode by tapping “Bilateral”or “Unilateral”button on the screen.
Bilateral Test Mode Selected
Unilateral Test Mode Selected
Once mode is selected, press the →to advance to the following Device Information screen:

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DPNCheck NC-040 Device User Manual
©2022 NeuroMetrix, Inc. All Rights Reserved. PN2205700 Rev A
The above sample Device Information screen is for illustration only. The actual display content on your
DPNCheck device may be different. The screen displays the following:
•Device Serial Number (SN): 15000001 (also viewable from the inside of the device battery
compartment)
•Hardware Version (HW) (example: A)
•Software Version (FW) (example 1.0.77.29)
Press CLOSE icon to exit this screen and return to Home screen.

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DPNCheck NC-040 Device User Manual
©2022 NeuroMetrix, Inc. All Rights Reserved. PN2205700 Rev A
CHAPTER 4: OPERATING INSTRUCTIONS
This chapter explains the basic operation of the DPNCheck device.
4.1 Power On
To power on the device, press the button under the Display Screen (refer to picture on page 4 for button
location).
4.2 Power Off
The device will power off automatically after 1-2 minutes of inactivity.
Note: The last test is saved on the device until a new test is performed or until test is uploaded to the
Reporter PC application. Contact NeuroMetrix Customer Service to obtain a copy of the Reporter
application.

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DPNCheck NC-040 Device User Manual
©2022 NeuroMetrix, Inc. All Rights Reserved. PN2205700 Rev A
4.3 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 A). 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 B); prone with feet hanging off the
exam table (Figure C); and chair with one leg resting on a chair (Figure D). 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.
Figure A: Preferred Position; side
Figure B: Alternative Position; side
Figure C: Alternative Position; prone
Figure D: Alternative Position; Chair -- leg up

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DPNCheck NC-040 Device User Manual
©2022 NeuroMetrix, Inc. All Rights Reserved. PN2205700 Rev A
4.4 Test Procedure
Proper patient positioning, skin preparation, and device placement are essential to accurately
administer the test. The section below will demonstrate proper testing technique (refer to the
DPNCheck Reference Guide for detailed testing instruction and troubleshooting).
Step 1:
Position the patient so that the outer
ankle and calf can be easily accessed then
vigorously scrub the testing area with the
prep pad (provided with the biosensors).
Step 2:
Power on the device by pressing the
power button. The display will prompt
the user to Connect Biosensor.
Step 3:
Fully insert the biosensor into the port.
When inserted properly as shown, the
narrow tail of the biosensor will be fully
inside the port.
Step 4:
If you have not already done so, remove
the protective liner from the foam and set
aside for later use in protecting the foam
adhesive between tests.
Align the biosensor to the foam (provided
with the biosensors).

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DPNCheck NC-040 Device User Manual
©2022 NeuroMetrix, Inc. All Rights Reserved. PN2205700 Rev A
Step 5 (Bilateral Mode Only):
The display will prompt user to select
patient. Press either Same to continue
testing the same patient or New to start
testing a new patient.
Step 6:
The display will prompt user to select
limb. Select the leg to be tested on the
touch screen.
Step 7:
The display will then show Ready to Test
screen with the selection made, and the
green LED will illuminate. The blue left
arrow allows you to return to the
previous screen if needed.
Ready to Test screen
(Bilateral Mode)
Ready to Test screen
(Unilateral Mode)
Step 8:
Apply a small amount of Signa conductive
gel (provided with biosensors) to each
probe. The head of the probe should be
covered with gel.

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DPNCheck NC-040 Device User Manual
©2022 NeuroMetrix, Inc. All Rights Reserved. PN2205700 Rev A
Step 9:
Remove the backing from the biosensor.
Step 10:
Locate the patient’s outer ankle bone and
Achilles tendon. The long probe should
be placed behind the ankle bone, half
way between the bone and the Achilles
tendon.
Step 11:
Align the device on the lower calf by
pushing down firmly on the foam. The
arrow closest to the midline of the calf
should point to the back of the knee.
When the arrow is pointing properly, the
inner edge of the biosensor will then sit
adjacent to the midline (Achilles tendon).
Ensure that the entire biosensor and both
probes are making full contact with the
patient’s skin.
Step 12:
Press the button to start the test. The
display will show “Testing”. During the
test the LED blinks green when each
stimulus is delivered.
Maintain firm pressure on both the
biosensor and the probes throughout the
test. Test times may vary per patient but
normally lasts for 10-15 seconds.

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DPNCheck NC-040 Device User Manual
©2022 NeuroMetrix, Inc. All Rights Reserved. PN2205700 Rev A
How to Stop the Test: Anytime during the
test, you can lift the device from the
patient to stop the test. An error will be
displayed if you halt the test prior to
completion.
Step 13:
Once results are displayed the test is
complete and the device may be removed
from the leg.
Note: If, at the end of a test, the DPNCheck suspects that the limb may have been misidentified, the user
will be prompted to confirm the limb before the results are displayed.
If the user confirms that the correct limb was originally specified, then the test results are displayed. If
the user selects the limb that is not consistent with the limb specified at the start of the test, the test
will result in a Limb Not Confirmed error.
How to Stop the Test: Anytime during the test, you can lift the device from the patient to stop the test.
See Appendix F for troubleshooting.

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DPNCheck NC-040 Device User Manual
©2022 NeuroMetrix, Inc. All Rights Reserved. PN2205700 Rev A
4.5 Test Results Review –Single Limb Results
When the test is complete, the device will display the sural nerve conduction amplitude (Amp) in
microvolts (µV) and the conduction velocity (CV) in meters per second (m/s). In cases where the patient
has low amplitude (between 0-4 µV) and the CV cannot reliably be reported, only the amplitude will
display on the device.
Disconnect the biosensor to review test results if the results are no longer shown on the screen.
The screen below indicates that valid test results are available for Left limb. Press the limb indicator
(e.g., L) to review the test results for that limb:
Press the limb indicator to
review the test results →
If both limbs have a check mark above them, it indicates that results are available for both limbs
(Bilateral Mode only). Please refer to Section 4.6 for instructions on how to switch results
between two limbs.

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DPNCheck NC-040 Device User Manual
©2022 NeuroMetrix, Inc. All Rights Reserved. PN2205700 Rev A
To view the waveform for the test, press the area where the Amp and CV results are displayed. When
you touch that area, it will highlight with a blue outline. Once you remove your finger from the screen,
the waveform display will appear:
Numerical results for left limb
Press the area where the
Amp/CV results are
displayed to switch to
waveform screen →
Waveform display for left limb
When the waveform screen is first displayed, the waveform is displayed at a fixed -20µV to
+20µV scale. See Section 4.7 for instructions on how to change the waveform display scale.
To toggle back to the numerical results screen, press the waveform area and it will highlight with a blue
outline as seen below:
Waveform display for left limb
Press the waveform area to
switch to the Amp/CV result
screen →
Numerical results for left limb
In certain cases, a test may only show an Amplitude result on numerical screen as seen below:

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DPNCheck NC-040 Device User Manual
©2022 NeuroMetrix, Inc. All Rights Reserved. PN2205700 Rev A
Following a test, once the device has powered off and been turned back on or the button has been
pressed, the device will display the following indicating that there are results stored for the limb
indicated. Make sure that the biosensor is NOT connected in order to view Test Results screen.
4.6 Test Results Review –Results Available for Both Limbs
When the device is configured to Bilateral Test Mode (see Section 3.4 on how to select Test Mode
between unilateral and bilateral), results may be available for both left and right limbs of the same
patient. The screen below indicates that valid test results are available for both limbs. Press the limb
indicator (e.g., L) to review the test results.
Press one limb indicator (L
or R) to review the test
results for that limb →
The limb L inside a filled blue square indicates that test results for the other limb are available. To view
the results of the other limb, simply press the filled blue square.
Numerical results for left limb
Press the filled blue square
to view the test results of
the other limb →
Numerical results for right limb

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DPNCheck NC-040 Device User Manual
©2022 NeuroMetrix, Inc. All Rights Reserved. PN2205700 Rev A
When the waveform for a limb is displayed, if the upper right corner limb indicator is inside a filled blue
square, the waveform for the other limb can be viewed by pressing the blue square once.
Waveform display for left limb
Press the filled blue square
to view waveform of the
other limb →
Waveform display for right limb
When the waveform screen is first displayed, the waveform is displayed at a fixed -20µV to
+20µV scale. See Section 4.7 for instructions on how to change the waveform display scale.
To view the waveform of the same limb from the numerical result screen, press the area where the Amp
and CV results are displayed. When you touch that area, it will highlight with a blue outline. Once you
remove your finger from the screen, the waveform display will appear:
Numerical results for left limb
Press the area where the
Amp/CV results are
displayed to switch to
waveform screen →
Waveform display for left limb
To toggle back to the numerical results screen, press the waveform area and it will highlight with a blue
outline as seen below:
Waveform display for left limb
Press the waveform area to
switch to the Amp/CV
result screen →
Numerical results for left limb