NeuroMetrix Sensus User manual

User Manual
GET RELIEF GET ACTIVE GET SLEEP

SENSUS®Pain Management User Manual 1
TABLE OF CONTENTS
Chapter 1: Pain Relief with SENSUS.......................................... 3
Introduction ................................................................................... 3
What You Should Have Received.................................................. 4
Device Components...................................................................... 6
Chapter 2: Getting Started.......................................................... 7
Chapter 3: Device Basics............................................................ 9
Checking Battery.......................................................................... 9
Charging Battery ........................................................................... 9
Attaching Electrode..................................................................... 11
Device Placement........................................................................ 12
Chapter 4: Configuration .......................................................... 13
Chapter 5: Pain Therapy ........................................................... 14
Preparing for Therapy Session.................................................... 14
Starting Therapy Session ............................................................ 15
Adjusting Intensity During Therapy Session................................ 15
Ending Therapy Session.............................................................. 16
Chapter 6: Overnight Therapy.................................................. 17
Chapter 7: Electrodes ............................................................... 17
Chapter 8: Skin Care.................................................................. 18

SENSUS®Pain Management User Manual
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TABLE OF CONTENTS CONT.
Chapter 9: Maintenance, Safety, and Service......................... 21
Maintenance................................................................................ 21
Cleaning ...................................................................................... 21
Device Storage............................................................................ 22
Disposal....................................................................................... 22
Limited Warranty ......................................................................... 22
APPENDIX A: Indicator Light.................................................... 24
APPENDIX B: Troubleshooting................................................. 25
APPENDIX C: Frequently Asked Questions ............................ 28
APPENDIX D: Alternate Placement Sites ................................ 33
APPENDIX E: Automatic Restart.............................................. 34
APPENDIX F: Technical Specifications ................................... 35
APPENDIX G: Prescribing Information .................................... 38
APPENDIX H: Symbols.............................................................. 42
APPENDIX I: Electromagnetic Compatibility Declaration ..... 43

SENSUS®Pain Management User Manual 3
Chapter 1: Overview
Introduction
The SENSUS®Pain Management System is an innovative
wearable medical technology that provides relief from chronic
pain. It consists of a device and an electrode that attaches to the
device. The device is worn on your upper calf, a few inches below
the knee, and is controlled by a single button.
SENSUS provides pain relief by comfortably stimulating the
nerves that carry normal, non-painful sensations to your brain.
Electrical stimulation of these nerves is believed to change the
levels of certain natural chemicals in your nervous system that
decrease your pain.
Pain relief is initiated by simply pressing a button on the device.
Each therapy session is 60 minutes. After your rst session,
therapy will automatically restart every other hour. Pain relief
usually begins within 15 minutes of the start of a therapy session
and may last up to an hour following the end of a session. You
have complete control and can start or end therapy anytime.
You should review this User Manual carefully. Chapter 2 shows
you how to get started. Chapters 3–5 provide detailed instruc-
tions on device use. Chapter 6 describes device use during sleep.
Chapter 7 offers tips for taking care of the electrodes. Chapter
8 provides information on preventing skin irritation, particularly
if you have sensitive or dry skin. Appendix C gives answers to
frequently asked questions.
If you have any questions about how to use SENSUS please call
NeuroMetrix customer service at [phone].

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4
What You Should Have Received
Upon receiving your SENSUS Pain Management System you
should inspect its contents to make sure all of the following are
included and undamaged (see Figure 1).
A. SENSUS Device
B. Small and Large Replacement Straps
C. USB Cable
D. AC Adapter
E. User Manual
You may also have received electrode packages (Figure 2). If any
of the items appear damaged, contact your supplier.

SENSUS®Pain Management User Manual 5
Figure 2.
Figure 1.
A
B
C D
User Manual
Get Relief Get Active Get Sleep
Carrying
Case
E

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Device Components
The device has the following components:
1Push button
2Indicator light
3Adjustable Velcro®strap
4Two electrode connector snaps
5USB port (not seen in image, port is on side of device)
5
4
1
2
33

SENSUS®Pain Management User Manual 7
Briey press the button.
charged
recharge
Snap in a new electrode.
Step 1: Check Battery
Step 2: Attach Electrode
Chapter 2: Getting Started
You must congure your device before rst use.
Press and hold button for 10 seconds until the
indicator light is steady green.
Briey press the button whenever you feel a
sensation under the electrode. The sensation will
pause with each button press. You will typically
press 3-6 times. When the light turns off, you are
done conguring your device.
Step 3: Place Device
Remove liner and place the
device on the upper calf of
either leg, 1-2 inches below
knee. The exact position is
not critical.
Step 4: Configure (First Use Only)
The following instructions will help you start using SENSUS.
For additional details, please review Chapters 3-8.
These instructions are also available in video format at:
www.SENSUSRx.com/Instructional/video.html

SENSUS®Pain Management User Manual
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If you need assistance, call 1-888-786-7287.
Helpful Tips
• Entire electrode should contact skin
• Every few hours, make sure device fits securely around your leg
• Run electrode under water if it stops adhering to skin
• Change electrode every 2 weeks
Briey press the button. The indicator
light will blink green and the intensity will
automatically increase to your therapeutic
level over 2 minutes. You should feel a
strong but comfortable sensation.
Intensity: Briey press the button;
each press decreases intensity.
Intensity: Hold button down; intensity
will increase while button is down.
Therapy: Press button 4 times to stop therapy.
A therapy session lasts 1 hour. After starting your rst session,
therapy will automatically restart every other hour.
Step 5: Start Therapy
Air-out skin after wearing several hours or overnight; device
will pulse on and off for 1 minute as a reminder.

SENSUS®Pain Management User Manual 9
Chapter 3: Device Basics
Checking Battery
With the device in your hand, briey press the
button to check the battery (Figure 3). The
indicator light will ash green if the battery has
sufcient charge. If indicator light ashes red
or does not ash at all, the battery needs to be
recharged (see below for charging instructions).
Charging Battery
A fully charged battery typically provides 20-40 hours of use.
To charge the battery:
1. Plug the USB cable into the USB port on the side of the device.
The USB port is protected by a rubber cover. To access the
USB port, rotate the cover until the connector is exposed
(Figure 4).
Figure 3.
charged
recharge
Figure 4.

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2. Plug the other end of the cable into the AC Adapter
(Figure 5). The cable should not be plugged into a computer
USB port for charging.
Figure 5.
3. The AC Adapter should then be
plugged into a standard electrical
outlet (Figure 6). The indicator light
on the device will show steady green
during charging and will turn off
when the battery is fully charged. It
will take approximately 3 hours to
charge an empty battery. When the
battery is fully charged, unplug the
cable from the device.
If the light blinks red while device is connected to the outlet,
charging has failed.
If the battery is too low to start a therapy session, you can charge
the device for approximately 20 minutes to provide enough
charge for one therapy session. To conrm, disconnect the USB
cable from the device and briey press the button. If the indicator
light ashes green, battery has enough charge. If the indicator
light ashes red, reconnect the USB cable and continue charging.
Do not use your device with the USB cable connected.
Figure 6.

SENSUS®Pain Management User Manual 11
Attaching Electrode
You will need to attach a new electrode prior to rst use of the
device and every 2 weeks thereafter (can be extended up to 3
days if a new electrode is not available). You should reseal the
pouch if it contains an electrode. To attach an electrode, snap the
electrode into the two connectors as shown in Figure 7.
Only use SENSUS electrodes manufactured by
NeuroMetrix, Inc.
Remove the liner covering the electrode (Figure 8) prior to placing
the device on your leg. Remember to keep the liner as it should
be re-applied to protect the electrode when not in use.
A white label is afxed to each electrode liner (Figure 9). The rst
time you use a new electrode, write the date on the label. The
electrode should be replaced 2 weeks from this date (can be
extended up to
3 days if a new
electrode is not
available).
Figure 7.
Turn the device so that
the snap connectors
are visible.
Align the snaps on the electrode to the
snap connectors on the device. Insert
snaps until they are securely fastened.
Figure 8. Figure 9.

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Device Placement
Place the device on your upper calf about
1-2 inches below the knee (Figure 10).
You may place on either leg. Be sure the
electrode is only covering healthy skin that
is not irritated and does not have cuts or
other wounds. Position the device so that
it is comfortable, the button is accessible,
and you experience a comfortable
sensation during therapy. You may position
the device with the button on the inside, outside, or back of the
leg. You should avoid placing the center compartment directly
over your shinbone.
If the device cannot be placed in the standard location as shown
in Figure 10 then refer to Appendix D for alternate site options.
Loop the strap through the buckle and attach it with the Velcro®
fastener as shown in Figure 11. The device should t securely
around your leg and be comfortable to wear. However, the strap
should not be so tight that the device and electrode substan-
tially indent the skin. The electrode should make smooth contact
with the skin. If there is buckling of the electrode, loosen the strap,
smooth the electrode and re-secure the strap. It is important that
all four electrode pads are in contact with your skin. If the pads
are only partially on the skin, then the stimulation may
feel uncomfortable.
Figure 10.
Figure 11.

SENSUS®Pain Management User Manual 13
Your device comes with small, medium and large straps. It is
shipped with the medium strap attached. If you require a different
strap, remove the medium strap and attach either the small or
large strap.
Chapter 4: Configuration
Before you begin using your device for the rst time you will
need to congure. You should also recongure your device if you
are no longer experiencing pain relief. Otherwise you do not
need to reconfigure your device, including when you switch
electrodes and alternate legs.
You should carry out the conguration process in a quiet
area without distractions. It is best to congure using a
new electrode.
Conguration Procedure
Snap in a new electrode.
Remove liner and place the device on the upper
calf of either leg, 1-2 inches below knee. The
exact position is not critical.
Press and hold button for 10 seconds until
the indicator light is steady green. Briey press
the button whenever you feel a sensation under
the electrode. The sensation will pause with each
button press. You will typically press 3-6 times.
When the light turns off, you are done conguring
your device.
STEP 1
STEP 2
STEP 3

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If your doctor prescribed two devices, congure one device at a
time. If you have difculty with conguration, call [phone].
Device is congured for a single person and should not
be shared.
Chapter 5: Pain Therapy
During a therapy session, the device will comfortably stimulate
the nerves in your leg to provide pain relief. Each therapy session
lasts 60 minutes, and a new session will automatically restart
every other hour. See Appendix E to turn automatic restart off.
To maximize pain relief, you should feel a strong but comfortable
sensation. The intensity that you will require is estimated based
on your device conguration. However, because of differences
among people, this estimated intensity may be too low and feel
weak, or too high and feel uncomfortable. In either case, you
should adjust the intensity as described on page 15. The greatest
pain relief will be obtained when you set the intensity to the
highest level that is also comfortable. The device will remember
changes to the intensity and you should not need to adjust
often. Please follow the steps on the following pages for a
therapy session.
Preparing for Therapy Session
Before starting a therapy session make sure you have an
electrode attached to the device. You should also check the
battery to ensure it has an adequate charge. Place the device
on your leg as described in Chapter 3.

SENSUS®Pain Management User Manual 15
Starting Therapy Session
To start a therapy session, briey press
the button (Figure 13). The indicator light
will blink green for the duration of the
therapy session.
The intensity will gradually increase over
the rst two minutes to the intensity that
was determined when you congured your
device. This intensity will be stronger than what you experienced
during conguration. You may not feel anything for the rst 10-15
seconds, however, the blinking green light indicates the device
is functioning properly. Therapy will continue for 60 minutes. You
may feel a strong sensation at rst but it will typically fade to a
comfortable level after a couple of minutes. If the sensation is
uncomfortable or painful, you should decrease the intensity as
described in the next section.
Once your therapy session has begun, you may cover the device
with your clothing. You should be careful not to dislodge the
device and electrode when covering with clothing. It is best to
wear loose tting clothing so that you can access the device.
You may go about your normal activities during a therapy session.
Do not shower, bathe or swim with the device on your leg.
Adjusting Intensity During Therapy Session
Frequent adjustments should not be necessary; however, if the
sensation is not strong, if it feels uncomfortable, or your calf
muscle is twitching, please follow the instructions below:
Intensity: Briey press the button; each press decreases
intensity.
Intensity: Hold button down; intensity increases while
button down.
Figure 13.

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You may adjust the intensity at any time during a therapy session.
Maximum pain relief will be obtained at the highest intensity
that is also comfortable.
Ending Therapy Session
A therapy session stops after 60 minutes.
If the device is on your leg, a new therapy
session will automatically restart 60 minutes
following the end of prior session.
To end a therapy session early press the
button 4 times (Figure 14). You should not
remove the device while it is stimulating,
so make sure that the indicator light is not blinking green before
removing the device and electrode from your leg.
After completing a therapy session, you may either leave the
device on your leg or remove it. If you remove the device, be
careful not to damage the electrode and remember to reapply
the liner (see page 18 for instructions on removing electrode).
If you leave the device on your leg for long periods of time, you
should check your skin frequently to make sure that it does not
get irritated. Chapter 8 provides information on skin care.
If a problem arises during a therapy session, stimulation will
stop and the indicator light will blink red for 2 minutes. Refer to
Appendix B for troubleshooting assistance.
Air-out skin after wearing several hours or overnight; device
will pulse on and off for 1 minute as a reminder.
Figure 14.
4x

SENSUS®Pain Management User Manual 17
Chapter 6: Overnight Therapy
You may use SENSUS at bedtime and throughout the night if
pain is preventing you from falling asleep or maintaining high
quality sleep.
Before going to sleep, make sure the device is placed securely
and comfortably around your leg. Start a therapy session by
briey pressing the button. This rst therapy session will stimulate
at your regular intensity level. Subsequent therapy sessions will
start automatically every other hour throughout the night.
If you are asleep during these sessions, the device will
automatically lower the intensity. The light will blink green
at a slower rate during these sleep sessions.
Air-out skin after wearing SENSUS overnight.
If you have concerns about the amount or quality of your
sleep, please discuss with your doctor.
If you have any questions regarding overnight use of SENSUS
call [phone].
Chapter 7: Electrodes
The SENSUS Electrodes are designed to
operate for 2 weeks (can be extended up
to 3 days if a new electrode is not avail-
able). You should hydrate your electrode
if the gel pads stop adhering to your skin.
Run the electrode under a gentle water
stream for 10 seconds as shown in
Figure 15. Let air dry before using.
Figure 15.

SENSUS®Pain Management User Manual
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Electrode Removal
You should be careful not to damage the
electrode when you remove it from your
upper calf area. Slowly peel the electrode
from your skin, while making sure that
each of the gel pads does not separate
from the electrode (see Figure 16). Avoid
touching the gel with your ngers as that
can damage the gel and decrease the life
of the electrode. After removal of the electrode you should cover
it with the liner.
If you have difculty removing the electrode, refer to Chapter 8.
Electrode Storage
Electrodes should always be stored with the liner covering the gel
pads. You may snap the electrode into the device for convenient
storage. Electrodes should be stored at room temperature out of
direct sunlight.
Electrode Replacement
The electrode should be replaced prior to two weeks if stimulation
becomes painful despite hydrating the electrode gel pads and
positioning the device so that the entire electrode is making
smooth contact with the skin.
Chapter 8: Skin Care
SENSUS works by electrically stimulating your sensory nerves
through your skin. Some people have dry or sensitive skin, and
it is important to regularly monitor your skin where it contacts the
Figure 16.