CIONIC
## Neural Sleeve
NS-100
## Instructions
For Use
---
# RX ONLY | Cionic Neural Sleeve Instructions for Use
## All Rights Reserved
No part of this Instructions for Use publication may
be reproduced, transmitted, transcribed, stored
in a retrieval system, translated into any language
or computer language, in any form or by any third
party, without prior permission from CIONIC Inc.
## Copyrights
CIONIC™, the CIONIC Logo™ and the Neural
Sleeve™ are copyrights of CIONIC Inc.
## Patents Pending
Aspects of the Neural Sleeve are covered by
patents and patent applications.
## How it Works
The Cionic Neural Sleeve uses a combination
of continuous motion analysis and Functional
Electrical Stimulation (FES). Sophisticated sensors
continuously monitor movement in real-time to
evaluate muscle firing and limb position, and
personalized algorithms deliver FES to activate the
necessary muscles precisely coordinated to the
gait cycle.
## Disclaimer
CIONIC Inc. and its affiliates shall not be liable
for any injury or damage suffered by any person,
either directly or indirectly, as a result of the
unauthorized use or attempted repair of the Neural
Sleeve and all of its components. CIONIC does not
accept any responsibility for any damage caused
by the Neural Sleeve, either directly or indirectly,
as a result of use and/or repair by unauthorized
personnel.
## Environmental Policy
Users are advised that when changing
electrode pads on the Neural Sleeve, care
should be taken to dispose of the old electrodes
and plastic packaging from the new electrodes
in the correct manner, where applicable, parts
should be recycled. For more detailed information
regarding the recommended procedures, please
contact CIONIC Inc. CIONIC Inc. is committed to
continuously seeking and implementing the best
possible manufacturing procedures and servicing
practices.
## Warranty
The Cionic Neural Sleeve and the Control Unit
carry a one-year warranty, starting at the date
of delivery. The warranty covers any defects in
materials and workmanship when used normally
in accordance with CIONIC’s published guidelines.
CIONIC’s published guidelines include but are
not limited to information contained in technical
specifications, user manuals, and service
communications.
CIONIC does not warrant that the operation of the
Cionic Neural Sleeve will be uninterrupted or errorfree. CIONIC is not responsible for damage arising
from failure to follow instructions relating to the
Cionic Neural Sleeve’s use.
This Warranty does not apply:
• to consumable parts, such as batteries or
protective coatings that are designed to
diminish over time, unless failure has occurred
due to a defect in materials or workmanship
• to cosmetic damage, including but not limited
to tears, scratches, dents and broken plastic
on ports unless failure has occurred due to a
defect in materials or workmanship
• to damage caused by use with a third party
garment, component or product
• to damage caused by accident, abuse, misuse,
neglect, fire, liquid contact, earthquake or other
---
external cause
• to damage caused by corrosive substances or
exposure to harsh environments
• to damage caused by operating the Cionic
Neural Sleeve outside CIONIC’s published
guidelines
• to damage caused by service (including
upgrades and expansions) performed by
anyone who is not a representative of CIONIC
• to a Cionic Neural Sleeve that has been
modified to alter functionality or capability
without the written permission of CIONIC
• to defects caused by normal wear and tear or
otherwise due to the normal aging of the Cionic
Neural Sleeve
Visit cionic.com/legal/terms for additional
warranty terms and for how to obtain warranty
service.
**Customer Support**
Telephone: +1 (888) 481-3724
CIONIC, Inc.
1500 Green Hills Road STE 109b
Scotts Valley, CA 95066
cionic.com
---
## Chapter 1
**Introduction to Your Neural Sleeve........................4**
Cionic Neural Sleeve System NS-100
Neural Sleeve User Manual
## Chapter 2
## Basic FES Configuration Mode Safety Information........................................................5
**Safety Information........................................................5**
Indications for Use
Environment of Use
Contraindications
Warnings
Precautions
Adverse Reactions
Proper Use
## Chapter 3 Environmental Conditions that
**Affect Use........................................................................7**
Radio Frequency (RF) Communication Info.
Conformity Certification
Travel and Airport Security
## Chapter 4
## Chapter 10 Neural Sleeve Device Description..........................8
**Neural Sleeve Device Description..........................8**
Control Unit
Control Unit Button
Neural Sleeve
Neural Sleeve Electrodes & Electrode Pads
Control Unit Charger
## Chapter 5
## Neural Sleeve.................................................................11
Downloading the CIONIC App
Applying Electrode Pads to the Neural Sleeve
Putting on the Neural Sleeve
Apply Sleeve to the Quadriceps
Apply Sleeve to the Hamstrings
Apply Sleeve to the Shin
Apply Sleeve to the Calf
Plugging the Neural Sleeve into the Control Unit
## Chapter 6
## Chapter 7
## CIONIC App.....................................20
**CIONIC** App Settings
Video Onboarding to Set Up Your Neural Sleeve
Navigation
Home Screen
Settings
History Screen
Help Screen
Connecting the CIONIC App to the Control Unit
Symbols
**Using Programs and Exercises.......................................26**
Calibration
Operating Modes
Configuring Stimulation
Basic FES Configuration Mode
Advanced FES Configuration Mode
Adjusting Stimulation
Using Gait Assist for Mobility
Using Exercise Programs
Chapter 8
**Maintenance and Cleaning..............................................32**
Daily Maintenance and Storage
Charging
Replacing the Neural Sleeve Electrode pads
Cleaning the Neural Sleeve
Chapter 9
**Skin Care................................................................................35**
Taking Care of your Skin
Chapter 10
**Firmware Upgrade...............................................................36**
Control Unit Firmware Upgrade
Upgrade Your Neural Sleeve Firmware
If Your Neural Sleeve Doesn’t Need to be Upgraded
Errors While Upgrading
Verify Your Firmware Version
Chapter 11
**Troubleshooting...................................................................40**
Control Unit Fails Adherence Check
Control Unit is Not Visible in Your CIONIC App
Control Unit is Unable to Pair with Your CIONIC App
If You Feel Sharp, Uncomfortable Pain
Stimulation Feels Uncomfortable
Control Unit is Malfunctioning
Factory Reset
Control Unit Battery Maintenance
Disposal
Chapter 12
**Technical Specifications...................................................41**
Chapter 13
**List of Symbols.....................................................................42**
Chapter 14
**Wireless Information..........................................................43**
Electromagnetic Compatibility (EMC) Information
## Maintenance and Cleaning..............................................32 Proper Use
## Cleaning the Neural Sleeve Affect Use........................................................................7
## Chapter 11 Neural Sleeve.................................................................11
---
# CHAPTER 1 | Introduction to Your Neural Sleeve
The Neural Sleeve is a platform for the measurement and augmentation of mobility composed of the legworn Neural Sleeve, a battery-powered Control Unit and a mobile application (the CIONIC App). It addresses
mobility limitations to support both rehabilitation and functional improvement. The Neural Sleeve includes
up to 24 electrodes that wrap around your upper and lower leg. The Neural Sleeve System consists of the
fabric sleeve (available in various sizes), a Neural Sleeve Control Unit, a charging cable and up to 4 packets
of 12 electrode pads. To operate the Neural Sleeve, you will need to download the CIONIC App which can be
accessed through most Apple (iOS) and Android smartphones or tablets.
To get started, go to cionic.com/app where you’ll be able to download and access the app, and register
and authenticate the mobile device.
Figure 1 | Neural Sleeve System
## Cionic Neural Sleeve System NS-100:
• **Sleeve SL-100** consists of up to
24 electrodes that wrap around the
lower and upper leg. Sensors within
the sleeve provide precise real-time
3-dimensional orientation, calibrated
acceleration, and angular velocity using
an inertial measurement unit (IMU) and
electromyography (EMG) sensing.
• **Control Unit DC-100:** A portable
electronic device worn within the sleeve
that provides sensing and stimulation
capabilities. It is removable and powered
by a rechargeable lithium polymer battery.
• **Mobile Application:** The Control Unit is
enabled through the CIONIC App that can
run on iOS and Android devices.
**CAUTION: It is recommended that you**
**read the Instructions for Use carefully**
**before using your Neural Sleeve.**
CONTENTS
## Neural Sleeve User Manual
This document includes:
• How to set up and operate your Neural Sleeve
• Important safety information
• How to clean and maintain the Neural Sleeve
• Troubleshooting tips
---
# CHAPTER 2 | Safety Information
## Indications for Use
The Cionic Neural Sleeve NS-100 is intended to
provide ankle dorsiflexion and/or plantarflexion
in adult individuals with foot drop and/or to assist
knee flexion or extension in adult individuals with
muscle weakness related to upper motor neuron
disease/injury (e.g. stroke, damage to pathways to
the spinal cord). The Cionic Neural Sleeve NS-100
electrically stimulates muscles in the affected leg
to provide ankle dorsiflexion and/or plantarflexion
of the foot and/or knee flexion or extension; thus, it
also may improve the individual’s gait.
• Facilitate muscle re-education
The Cionic Neural Sleeve NS-100 may also:
• Prevent/retard disuse atrophy
• Maintain or increase joint range of motion
• Increase local blood flow
**Please read the precautions with**
**symbols to ensure that your device**
**is in the proper condition and you**
**are safe to use it.**
## Environment of Use
The Cionic Neural Sleeve NS-100 is intended to be
used in a clinical or home use setting.
## Contraindications
• Individuals with implanted demand-type cardiac
pacemaker or defibrillators should not use the
Neural Sleeve.
• The Neural Sleeve should not be used over
malignant tumors.
• The Neural Sleeve should not be placed over
any areas where existing thrombosis is present.
## Warnings
• The Neural Sleeve should not be used on an
area of the leg where a regional disorder, such
as a fracture or dislocation, could be adversely
affected by motion from stimulation.
• The long-term effects of chronic electrical stimulation
are unknown.
• The Neural Sleeve System components are nonsterile.
• The Neural Sleeve should not be worn over swollen,
infected, or inflamed areas or skin eruptions, such as
phlebitis, thrombophlebitis and varicose veins.
• When in doubt about correct operation or if you
feel discomfort or pain, turn off the stimulation and
remove the Neural Sleeve. If the stimulation does not
turn off for any reason, remove the Neural Sleeve.
• Simultaneous connection of the Neural Sleeve to the
user and high-frequency surgical equipment may
result in skin burns where the stimulator electrodes
touch and damage to the Control Unit.
• Do not use the Neural Sleeve within three feet of
short wave or microwave therapy equipment. Such
equipment may produce instability in the Control
Unit’s output.
• The Neural Sleeve NS-100 may be interfered with
by other equipment, even if that other equipment
complies with International Special Committee on
Radio Interference, International Electrotechnical
Commission (CISPR) emission requirements.
## Precautions
• Use the Neural Sleeve with caution if you have a
suspected or diagnosed heart condition, have a
tendency to hemorrhage following trauma or fracture,
have had a recent surgery or procedure in which
muscle contractions may disrupt the healing process,
have an epilepsy diagnosis or suspected diagnosis of
epilepsy/seizures, or have need for application of the
Neural Sleeve over areas of the skin that lack normal
sensation.
• The Neural Sleeve may cause some users to
experience skin irritation, an allergic reaction, or
hypersensitivity to the fabric, electrical stimulation
or a similar electrically conductive medium. Do not
wear the Neural Sleeve during any diagnostic or
therapeutic medical procedure such as an x-ray,
ultrasound, MRI, EMG, etc.
• Replacement electrode pads for the Neural Sleeve
should only be provided by CIONIC.
---
• Do not use the Neural Sleeve System in an
oxygen rich environment.
• The Control Unit should be unplugged from the
Neural Sleeve before removing the sleeve and
before removing or replacing any electrode pads.
• Safe use of the Neural Sleeve during pregnancy
has not yet been established.
• Existing skin conditions on the legs may be
aggravated or irritated if occuring in the area
where the Neural Sleeve is worn.
• Never use the Neural Sleeve with worn-out
electrode pads or exposed, frayed or broken
wires.
• Users with significantly limited mobility and
coordination should seek assistance while using
the Neural Sleeve.
• The Neural Sleeve, Control Unit and all associated
components should be protected from any
exposure to water.
• The Neural Sleeve and Control Unit should not
be stored where temperatures may exceed -4˚F
to +140˚F (-20˚C to +45˚C). Turn the Control Unit
off should it be exposed to these temperature
extremes.
• If the device has been stored in a cold or hot
environment, allow it at least 5 minutes to
acclimate to room temperature before operating.
• Do not modify or attempt to repair the Neural
Sleeve or Control Unit yourself. Contact CIONIC if
you experience any problems not covered in this
document.
• The Neural Sleeve is only intended to be used
on the leg of the user who has obtained a
prescription for use and has received a properly
fitting sleeve. It should never be worn by anyone
else or used on any other part of the body.
• The Neural Sleeve should not be worn while
driving, operating machinery or performing any
activity in which involuntary muscle contractions
could lead to injury.
## Adverse Reactions
• The Neural Sleeve should not be operated in the
presence of liquids or flammable substances.
Skin irritations and burns beneath the electrode
pads can occur with the use of surface electrical
stimulation devices. While it is normal to see reddened
areas under the electrode pads, they should disappear
within a few hours. NEVER continue stimulation over
irritated skin or open wounds. If the conditions persist
after you discontinue use of the Neural Sleeve, consult
with an authorized CIONIC Mobility Specialist, or your
physician or therapist.
In the unlikely event that any of the following occurs
while using the Neural Sleeve, stop use immediately
and consult with your physician or therapist;
• Feeling of stress to the heart or unusual shortness
of breath
• Significant increase in muscle spasticity
• Sudden and noticeable swelling of the leg, knee,
ankle or foot
• Any pain or other unanticipated and concerning
reaction
## Proper Use
Both the safety and efficacy of the Neural Sleeve
depend on the proper use and handling of the system.
Improper use of the device and its components can
result in failure of the device or injury. Steps can be
taken to ensure the Neural Sleeve is operating properly
and safely, which include:
• Make sure the Control Unit is fully charged before
initial use, before daily use, and after any extended
storage. Charging instructions can be found in
Chapter 8: Maintenance and Cleaning.
• Regularly check the Neural Sleeve and Control Unit
for wear and tear.
• Be sure to firmly secure the electrode pads to the
skin.
• Never use the Neural Sleeve if it appears in any
way to be malfunctioning, or if you notice any
change in its normal operation.
• The Neural Sleeve is only intended for use on the
legs only. Do not apply the Neural Sleeve to any
other part of the body.
---
## CHAPTER 2 | Safety Information (cont.)
• Using a wet washcloth, clean the area of the skin
to be covered by the Neural Sleeve, removing any
oils or lotions. Allow skin to dry before putting on
the Neural Sleeve.
• Excessive hair on the legs can reduce sensor and
electrode pad contact with the skin. If necessary,
trim excessive hair. Don’t shave immediately
before use.
• Replace the electrode pads every two to four
weeks, or sooner if the condition or effectiveness
of the electrode pads has diminished.
• Always cover the electrode pads with the storage
covers after each use.
• Effective current densities above 2 mA/cm2
require increased attentiveness of the user for all
electrode surfaces.
## CHAPTER 3 | Environmental Conditions that Affect Use
## Radio Frequency (RF) Communication Information
The Neural Sleeve Control Unit communicates
via radio communication and have been tested
and found to comply with the limits for a Class
B device, pursuant to Part 15 (RF Devices) of the
Federal Communications Commission (FCC) Rules.
These limits are designed to provide reasonable
protection against harmful interference in a
residential installation. This equipment generates,
uses, and can radiate RF energy and, if not installed
and used in accordance with the instructions,
may cause harmful interference to radio
communications. However, there is no guarantee
that interference will not occur in a particular
installation. If this equipment does cause harmful
interference to radio or television reception, which
can be determined by turning the equipment off
and on, the user is encouraged to try to correct
the interference by one or more of the following
measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the
equipment and receiver.
The antenna of the transmitter must not be colocated or operating in conjunction with any other
antenna or transmitter. Portable and mobile RF
communications equipment may affect the Neural
Sleeve NS-100.
## Conformity Certification
This device may not cause harmful interference, and
it will accept any interference received, including
interference that may cause undesired operation.
This equipment complies with FCC RF radiation
exposure limits set forth for an uncontrolled
environment.
## Travel and Airport Security
The Neural Sleeve charger is compatible with
voltages 110/220 V
Turn off your Control Unit before going through
airport security. It is advised to carry a copy of
your Neural Sleeve prescription and a description
of the product, which can be useful when passing
through customs as well. To request a copy of your
prescription or the product description, please email
the Cionic Care team at support@CIONIC.com.
Please use the subject heading, “Travel Request.”
**NOTE: The Neural Sleeve contains**
**radio transmitters. The Federal**
**Aviation Administration (FAA) rules**
**require that all radio-transmitting**
**devices be turned off during flight.**
---
## Neural Sleeve
## Control Unit
The Neural Sleeve Control Unit is the computer
that interfaces with the CIONIC App via Bluetooth
to control the Neural Sleeve. It is also used to turn
the system on and off. The Control Unit is powered
by a single rechargeable ion battery.
• To turn the Control Unit on, press the
button once.
• To turn the Control Unit off, press and hold the
button. The light indicator will turn orange and
fade out.
**CAUTION: Inspect the Control Unit**
**for damage to the plastic enclosure**
**prior to use. Contact CIONIC should you**
**observe any damage.**
Table 1 | Control Unit Visual Indicators
Figure 2 | Control Unit
| LIGHT DISPLAY | DISPLAY PATTERN | DESCRIPTION |
| --- | --- | --- |
| | Solid white | Control Unit initializing after turning on or restarting |
| | Blinks green | Activity in progress |
| | Solid yellow | Stimulation active>10mA |
| | Pulses orange | Battery charging |
| | Solid green | Battery fully charged. Disconnect from charger |
| | Pulses green | Unit on |
| | Pulses red | Battery low<10%. Charge Control Unit |
| | Blinks red 2x | Battery low<5%. Stop use and charge Control Unit. |
| | Red to yellow 3x | Critical hardware error.Refer to Chapter9 Troubleshooting |
| | Blinks green 3xs | Sleeve was plugged in |
| | Blinks blue | Bluetooth® pairing mode active |
| | Solid blue for 3 seconds | Bluetooth® pairing complete |
| | Blinks orange 3x | Bluetooth® pairing failed.Retry pairing |
| | Orange to fade out | Powering off |
| | Pulses purple | Button pressed and stimulation paused |
| | Blinks red | Factory reset mode active(see Chapter9) |
| | Solid red | Factory reset complete |
---
## Control Unit Button
The Control Unit contains a button used for multiple purposes.
Table 2 | Control Unit button operations
| DESIRED ACTION | BUTTON OPERATION |
| --- | --- |
| Turn Control Unit On | Press the button |
| Turn Control Unit Off | Press and hold the button for 5 seconds |
| Pause and Resume Stimulation | Press button while stimulation is on |
| Factory Reset | Troubleshooting; See Chapter 9 |
## Neural Sleeve
The Neural Sleeve is a wearable fabric sleeve
that fits the leg. It is available in right or left leg
configurations (Figure 3), offered in multiple
sizes. The Neural Sleeve is designed to facilitate
movement of the foot, lower leg, and upper leg,
depending on the programming.
®
The Neural Sleeve has four Velcro panels to hold
the sleeve firmly in place. The pocket at the top of
the Neural Sleeve holds the Control Unit.
Figure 3 | Cionic Neural Sleeve Left and Right
Neural Sleeve
**Cionic Neural Sleeve Instructions for Use**
---
## Neural Sleeve Electrodes & Electrode Pads
## Neural Sleeve
The Neural Sleeve contains up to 24 electrodes. Each metal disc requires an electrode pad containing a
conductive film that provides current control. They are reusable (up to four weeks), self-adhering, and serve as
an interface between the user’s skin and the Neural Sleeve metal discs. (Figure 4)
Figure 4 | Applying Electrode Pads to Metal Discs
## Control Unit Charger
The Control Unit includes a 3-foot long (1m) USB Type A to Type C charging
cable, as well as a removable power adapter.
**WARNING: Only the**
**electrode pads**
**provided by CIONIC**
**should be used with**
**the Neural Sleeve. To**
**reorder electrode pads**
**please visit**
support.cionic.com
**WARNING: The**
**electrode pads carry**
**an expiration date**
**which is printed on**
**the packaging. Verify**
**that the expiration**
**date is at least two**
**weeks in the future**
**prior to use.**
## weeks in the future Control Unit Charger
Figure 5 | Control Unit and Charger
**WARNING: Only use the Control Unit**
**charging cable and power adapter**
**that was included with your Neural**
**Sleeve. Using any other charger**
**could cause damage to the unit.**
---
Figure 6 | Major Leg Muscle Groups
## Downloading the Mobile App
The CIONIC App is a required application that must be downloaded onto a mobile device
(smartphone or tablet) in order to operate the Neural Sleeve. All the set-up instructions
detailed in the following pages are available in a step-by-step process within the CIONIC
App. It will also act as the only interface needed to operate the Neural Sleeve. Use your
smartphone or tablet to visit cionic.com/app to access the app. The CIONIC App communicates with the
Control Unit through Bluetooth® Low Energy.
---
## Applying Electrode Pads to the Neural Sleeve
In order to use your Neural Sleeve, you must attach the sheets of electrode pads onto the metal discs on
the inside of your Neural Sleeve (Figure 7). Open the sleeve and place it on a flat, solid surface. There are
four groups of metal discs which correspond to muscles on your leg.
Figure 7 | Electrode Pad Application Stages
Sleeve Without Electrode Pads
Sleeve With Electrode Pads
Sleeve With Electrode
Storage Covers
## Step 1
Starting with one of the top panels of the
Neural Sleeve, select one sheet of electrode pads.
Carefully remove the clear protective film from the
grid side of the electrode pads. Protective film can
be discarded.
## Step 2
Carefully place the sheet of electrode pads, grid
side down, in accordance with the panel of metal
discs. The electrode pads must be centered on the
metal discs, so you should not see any of the red
square.
---
## Step 3
Firmly press each electrode pad onto the metal
discs on the sleeve fabric. Leave the clear film on
the pads.
## Step 5
When complete, carefully remove the clear plastic
film cover from the top of each panel of electrode
pads. Discard the clear plastic film. Then cover
each section with the corresponding storage
cover. Note that the lower section of the Neural
Sleeve uses the larger cover and the top two
panels use the smaller storage covers. **The shiny**
**side of the cover should be in contact with the**
**electrode pads.**
## Step 4
Repeat this process for each panel of electrode
pads until all metal discs are covered.
**CAUTION: Before each use, it’s important**
**to inspect the Neural Sleeve and Control**
**Unit for obvious damage, including tears in**
**the fabric, broken electrical connections or**
**damage to the housing of the Control Unit.**
**If damage is suspected, contact CIONIC**
**technical support.**
**WARNING: Before applying the electrodes**
**to your Neural Sleeve for the first time,**
**make sure that you have verified that the**
**sleeve fits properly by watching the in-**
**structions in the CIONIC App.**
**Depending on your Cionic Neural Sleeve**
**model, the configuration of the metal disks**
**might be different from what is shown in**
**the pictures.**
**Lycra has a tendency to stretch over time,**
**especially during the initial wear. This**
**stretching is not a sign of wear and tear;**
**rather, it is a result of the fabric’s inherent**
**elasticity. The fibers, when subjected to**
**consistent use and movement, gradually**
**loosen up, allowing the sleeve to expand**
**and contract.**
---
Prior to using your Neural Sleeve for the first
time, you will have a consultation with a CIONIC
technician using the CIONIC App. This will provide
an opportunity to review the Neural Sleeve System
and CIONIC App prior to use. You can view tutorial
videos by going to **support.cionic.com**
## Putting on the Neural Sleeve
• While seated, remove your shoe from the side
on which you will be using the sleeve.
• Pick up the Neural Sleeve.
• Unfold the sleeve and place it over your leg so
that the connector is facing up and the wings
of the sleeves are facing outward (Image 1).
• Turn over the sleeve, ensure all the electrodes
are covered, and observe the opening in which
you will be sliding your foot through (Image 2).
• Turn the sleeve back over, and slide your foot
through the opening (Image 3).
• Pull the sleeve up your leg until the middle of
the sleeve is aligned with your knee cap
(Image 4).
## Apply Sleeve to the Quadriceps
• Pull the top of the sleeve down over your knee
and rest it on the shin with the storage cover
facing up (Images 5 & 6).
## Neural Sleeve
Image 1
Image 2
Image 3
Image 4
Image 5
Image 6
---
Image 7
Image 8
Image 9
Image 10
Image 11
Image 12
• Remove the storage cover exposing the six
electrode pads, making sure that all electrode
pads are still attached to the sleeve (Image 7).
Set the storage cover to the side.
• If needed, adjust your clothing to ensure
electrode pads will only come in contact with
the skin of your quadriceps.
• Pull the section of the sleeve back up over your
knee (Image 8), placing the electrode pads on
the skin of your quadriceps.
• Press down firmly on the sleeve to ensure
electrode pads adhere flat and securely to the
skin (Image 9).
## Apply Sleeve to the Hamstrings
• Adjust yourself toward the front of your chair.
• Reach behind the back of your upper leg and
grab the top wing of the sleeve (Image 10).
Guide the sleeve up and over, resting the sleeve
on your quadriceps with the storage cover
facing up (Image 11).
• Remove the storage cover exposing the six
electrode pads, making sure that all electrode
pads are still attached to the sleeve (Image 12).
• Set the storage cover to the side.
---
## Apply Sleeve to the Hamstrings (cont.)
• If needed, adjust your clothing to ensure
electrode pads only come in contact with the
skin of your hamstrings
• Pull the exposed panel of the sleeve back
under the hamstrings, pulling across tightly
to secure the Velcro connection points while
ensuring the electrode pads are in contact with
the skin of your hamstrings (Images 13 & 14).
• Press down firmly on the sleeve to ensure
electrode pads adhere flat and securely to
your skin.
## Apply Sleeve to the Shin
• Reach down and grip the bottom of the sleeve
by the ankle (Image 15).
• Pull the sleeve up and over your knee and rest
the sleeve on your quadriceps (Image 16).
• Carefully remove the storage cover exposing
the 12 electrode pads of the lower sleeve,
making sure that all pads are still attached to
the sleeve (Image 17).
• Set the storage cover to the side.
• Pull the panel of the sleeve back down over the
knee (Image 18).
## Neural Sleeve
Image 13
Image 14
Image 15
Image 16
Image 17
Image 18
---
Image 19
Image 20
Image 21
• Use the markings on the interior of the sleeve
to align to the shin bone, making sure to place
the top, inside gel pad on the muscle just below
and lateral to the knee with the two electrode
pads below close to the shin bone, but not
touching it (Images 19 & 20).
Image 22
• Press down firmly on the sleeve to ensure
electrode pads adhere flat and securely to
your skin (Image 21).
## Apply Sleeve to the Calf
• Reach behind the back of the lower leg and
grab the bottom wing of the sleeve.
• Pull the exposed panel of the sleeve back
under your calf, pulling across tightly to secure
the Velcro connection points while ensuring the
electrode pads are in contact with the skin of
your calf (Image 22).
• Press down firmly on the sleeve to ensure
electrode pads adhere flat and securely to
your skin (Image 23).
Image 23
To remove the Neural Sleeve, simply follow
these steps in reverse, starting by pulling down
on the sleeve.
You can access tutorial videos on how to correctly put on, align, and take off the sleeve by
visiting the app or by going to
support.cionic.com
---
## Plugging the Neural Sleeve into the Control Unit
• Pick up the Control Unit.
• Press the button, and ensure you see a pulsing
green light (Image 24).
• With the port connector facing up and the power
button facing out, slide the Control Unit into the
Neural Sleeve pocket (Image 25).
• Gently plug the Control Unit into the Neural
Sleeve connector cable, and ensure it is secure
(Image 26).
• You may now put your shoe back on, stand up,
and adjust your clothing over the Neural Sleeve.
## Neural Sleeve
Image 24
Image 25
Image 26
**CAUTION: if you have decreased mobility**
**and dexterity in one or both hands, please**
**place the Control Unit in the pocket of the**
**sleeve and plug it in before putting the**
**sleeve on your leg. This will help protect**
**the cable that connects your device to the**
**sleeve.**
---
COFK
---
The CIONIC App allows you to control the Neural Sleeve. The CIONIC App communicates with the
Control Unit over a Bluetooth® connection. The CIONIC App connects to the internet through either a
wireless or cellular signal. This allows you to log into the app, upload data, and receive programs.
## CIONIC App Settings
The CIONIC App resides on your smart device and requests permissions of functions
commonly used by apps. Table 3 outlines the settings required for operation of the CIONIC
App.
Table 3 | Settings For The CIONIC App
| SETTING | REQUIRED | DESCRIPTION |
| --- | --- | --- |
| Location | Yes | Required by the Operating System to communicate with CIONIC technical support |
| Bluetooth® | Yes | Required to communicate with the Control Unit |
| Local Network | No | Not applicable to CIONIC App |
| Microphone | Yes | Communicate with CIONIC technical support |
| Camera | Yes | Communicate with CIONIC technical support |
| Siri&Search | No | Not applicable to CIONIC App, only relevant for iOS |
| Notifications | Yes for Android devices Recommended for iOS devices | The CIONIC App will provide notifications while you are using your Neural Sleeve and in case there are updates available. |
| Cellular Data | Optional | Allows the CIONIC App to utilize your cellular network data to upload activity data. If this is not enabled, the app will hold your recordings until you are connected to WiFi |
---
## Video Onboarding to Set Up Your Neural Sleeve
Prior to using your Neural Sleeve you will have an onboarding session with a CIONIC Mobility Specialist
using the CIONIC App. This video conference will provide an opportunity to review the Neural Sleeve
System, customize your settings, and become familiar with the mobile app prior to use. Once you receive
your Neural Sleeve, you will receive instructions for how to schedule your appointment via the CIONIC App.
To reschedule at any time, contact support@cionic.com.
## Complete these steps prior to your Video Onboarding:
Install the CIONIC App onto your device
Record and upload the walking video
Try on your Neural Sleeve to verify it fits comfortably
Apply electrode pads to your Neural Sleeve
Charge your Control Unit
Charge your mobile device
Wear shorts or a skirt so your full leg is visible, with
shoes and an assistive device (if needed) on hand
Be seated in a comfortable chair near a space where
you can walk back and forth safely
Put on the Neural Sleeve
At the time of your appointment,
open the CIONIC App. You will
see an option to join the setup
session from the home screen
and confirm you are prepared
with all devices. You will meet
your CIONIC Mobility Specialist
virtually and begin the setup
process.
Table 4 | Remote Consultation Menu
| CIONIC App Remote Consultation SYMBOLS | |
| --- | --- |
| Your microphone is on. Press to mute yourself. | |
| Your microphone is off. Press to unmute yourself. | |
| Camera is on. Press to turn off. | |
| Camera is off. Press to turn on. | |
| Changes the camera view between the front-facing and rear-facing camera. | |
| Switch between your camera view and the technician camera view. | |
| Ends remote session. | |
| Toggles between video chat and app view. | |
---
## Navigation
The CIONIC App includes four primary sections to navigate.
## Home Screen
The app Home Screen (Figure 8) contains a list of programs available for use. The programs available to you
may vary depending on your Mobility Specialist’s instructions. These programs may change over time.
To view all programs, scroll down. To open a program or exercise, select the image for the desired item.
Figure 8 | CIONIC App Main Screen
Opens the Main Menu
Home Screen
Opens the Device Menu
---
## Settings
The Settings screen contains options for the CIONIC App (Figure 9).
Toggling the selector switch to the right enables the setting.
## Create/upload recordings
The Control Unit receives data from the Neural Sleeve and uses it temporarily to operate your device. If this
option is selected, data will be recorded in the Control Unit’s memory and used to improve our algorithms.
## Location tracking
If this is selected, your distance and elevation will be included with any recordings. Only relative location
is tracked, and this data is only collected to improve our
Algorithms. For Android devices, this option needs to be
enabled in order to connect to technical support.
## Allow cellular uploads
If data is recorded, recordings can be uploaded using
the user’s cellular data plan. Disable this if you only want
recordings uploaded when you are connected to Wi-Fi.
## Advanced FES Settings
If this is selected, you may access additional stimulation
parameters, including frequency and pulse width when
configuring FES.
## Metric
Toggling the selector will switch between imperial
(feet and inches) and metric (meters and millimeters)
measurements.
## Reset
• Reset help/tutorials - some instructional videos are
only shown one time. This selection will restore the
ability to watch the videos.
• Clear FES settings - this will remove all saved
settings.
## Sign out
Will immediately sign you out of the CIONIC App. You
will not need to sign out of the app unless instructed by
CIONIC.
Figure 9 | Settings Menu
---
## History Screen
The History screen lists all trends and activities
(Figure 10).
The summary at the top shows how your main
metrics (Daily Activity Time; Gait Speed; Stride
Length) are trending during the last 7 days or the last
30 days.
The summary at the top shows how your main
metrics (Daily Activity Time; Gait Speed; Stride
Length) are trending during the 7 days or the last 30
days. Below the summary you can find a list of all
the activities. Each entry lists the program that was
executed, the number of steps/repetitions done, and
the duration.
## Help Screen
The Help screen allows you to perform multiple
actions like reorder electrodes, account and
billing changes and gives you access to support
content, user manual and a library of instructional
videos that you can reference at any time. Select
the image to play a video. Videos include audio
narration. Increase speaker volume as needed.
## Report An Issue Screen
The “Report an Issue” screen on your device
provides a straightforward method to notify our
support team about any problems you encounter
while using the device. This feature allows you to
submit detailed information, including descriptions,
screenshots, and logs, which helps our engineers
diagnose and resolve issues more effectively.
When reporting an issue please make sure that the
Control unit is on and it is connected to the phone
in order to retrieve the device logs.
Figure 10 | History Screen
---
## Connecting the CIONIC App to the Control Unit for the first time
Communication between the CIONIC App and the
Control Unit is managed under the Device Menu.
The app and Control Unit communicate using
Bluetooth® communications. Your Control Unit must
be charged and within 5 feet of your mobile device.
The device should be ON, as indicated by a slowly
pulsing green indicator. If the device is not on, press
the button once.
• With the Control Unit on, press the button.
• Observe the indicator blinking blue.
• Open the Device Menu.
• Select “New Control Unit”.
• Follow the on-screen instructions to complete
the connection process.
Figure 11 | Control Unit Connection Screen
Figure 12 | Pairing The Control Unit
---
Once your device is connected, the following symbols apply:
## CAUTION:
**If you have multiple**
**Control Units, be sure**
**to select the proper**
**one or your system**
**will not work properly.**
Control Unit charging
## SYMBOLS
Control Unit connected
Control Unit connected but running low on battery
Control Unit detected
Control Unit cannot be connected. See Chapter 9 Troubleshooting
Control Unit is acceptably close to your mobile device
Control Unit is detected but out of reliable connection range
Restart Control Unit
## Control Unit settings
**Change Control Unit Name**
To customize the name of your device
## Unpair Control Unit
To end Bluetooth® pairing from your mobile device. This would be done
only if you wish to pair your Control Unit to a different mobile device.
## Start Firmware Upgrade…
You will receive a notification when updated firmware for your Control
Unit is available. Select this option to initiate the upgrade.
## Get Firmware Info
## Get Firmware Info If you have multiple
Learn more about the current version of firmware running on the
Control Unit.
## Disconnect from Control Unit
To disconnect the Control Unit from the phone (use this option only if
instructed by CIONIC)
---
The Cionic Neural Sleeve is intended to help improve your mobility through a combination of exercise and
functional assistance.
**Exercise programs** are intended to help you strengthen specific muscle groups that contribute to
walking. Exercises can be performed with or without muscle stimulation. Exercises are intended to be
performed sitting or standing while holding onto a secure surface when applicable.
**Assist Programs** are functional augmentation programs designed to assist and support your
movements by providing stimulation. Assist programs are intended to be used while walking or performing
other movements such as stationary exercise cycling.
## Calibration
Sensors in the Neural Sleeve measure leg muscle activity and leg movement, as well as verify the electrode
pads are working and are in contact with the skin. These sensors must be calibrated specifically to your
body at least once every time you wear your Neural Sleeve. Follow the on-screen instructions to complete
the calibration process (Figure 8). If calibration has been completed previously you may press the Skip
button to proceed to FES configuration.
Figure 13 | Neural Sleeve Calibration Process
---
## Operating Modes
## Assist Modes
Multiple programs may exist under the Assist
section of the Home Screen. These programs will
vary depending on your mobility needs and goals.
Use of the Gait Assist Programs are described in
the following pages.
## Exercise Modes
Multiple programs may exist under the Exercise
section of the Home Screen. These programs will
vary depending on your mobility needs and goals.
Programs can be added and removed throughout
your use of the Neural Sleeve System. Exercises
are designed to help you strengthen your
muscles and increase your tolerance of electrical
stimulation.
## Configuring Stimulation
The procedure for programming stimulation is
identical for all Assist and Exercise programs.
Stimulation is customized for the muscle(s)
involved in the program.
## Stimulation Parameters
The Neural Sleeve delivers small pulses of
electrical energy from the electrode pads.
Three parameters are controlled to optimize the
stimulation delivered to your body.
Figure 14 | Assist and Exercise Mode Screen
---
## Frequency
Stimulation is delivered in pulses that are measured
in Hertz (Hz), or number of pulses per second.
## Pulse Width
Each individual stimulation pulse turns on and
off within a very short time and is measured in
microseconds.
## Intensity
Each individual stimulation pulse has a magnitude or
strength, measured in milliamps (mA).
Figure 15 | Graphical Illustration of Stimulation
Waveforms
| PARAMETER | RANGE | INCREMENTS | IMPACT |
| --- | --- | --- | --- |
| Frequency | 5-100Hz | 5Hz | Comfort and effectiveness |
| Pulse Width | 100-400 microseconds | 100 microseconds | Strength of muscle contraction |
| Intensity | 0-100mA | 5mA | Strength of muscle contraction |
Stimulation is fully customizable for your comfort and to produce the desired muscle
reaction. There are two levels of programming: Basic and Advanced. Advanced
Mode is available only when enabling Advanced FES Settings (see Chapter 6).
## Basic FES Configuration Mode
In Basic Mode, the programming screen includes:
• An illustration of a leg showing orange and blue squares that represent the
electrode pads within the Neural Sleeve
• An enlarged view of the electrode pads that can be adjusted
• Slider control for the level of current (mA) delivered
• Option to adjust electrode percentage (press and hold on an electrode)
• Option to enter Advanced Mode (if setting enabled)
• Adjust intensity by pressing and holding the slider control and moving your
finger left and right. You may also tap the left or right of the circle to increase
or decrease
Press the lightning bolt to deliver a short burst of stimulation. This is used to
evaluate your comfort with the stimulation as well as the strength of the muscle
contraction produced. Press the “Next” button to advance through the individual
muscles if more than one muscle is enabled and the “Done” button when you
have finalized your stimulation parameters.
---
## Advanced FES Configuration Mode
In Advanced Mode, the programming screen
includes:
• An illustration of a leg showing orange and blue
squares that represent the electrode pads
within the Neural Sleeve.
• An enlarged view of the electrode pads that
can be adjusted
• Control for Frequency
• Control for Pulse Width
• Control for Intensity
• Option to enter Basic Mode
• Option to adjust electrode percentage (press
and hold on an electrode)
To adjust any parameter, press and hold the
number wheel below the desired parameter
and slide your finger up to increase or down to
decrease. You may also tap above or below the
number to increase or decrease. Each parameter
is adjusted separately.
Press the lightning bolt to deliver a short
burst of stimulation. This is used to evaluate
your comfort with the stimulation as well as the
strength of the muscle contraction produced.
Press the “Done” button when you have finalized
your stimulation parameters.
**WARNING: for safety reasons, you will**
**have to press the “test” button after**
**each 10mA increase in order to continue**
**increasing intensity**
Figure 17 | Advanced Mode FES Configuration
---
## Adjusting Stimulation
You will be able to program stimulation for up to four muscle groups. Available muscles may be added or
removed during the course of your use of the Neural Sleeve. Follow the FES programming instructions to
determine the strength and direction of each muscle movement.
• Shin - lifts your foot up, pulling your toes away from the ground
• Calf - presses your foot down, pointing your toes towards the ground
• Quadriceps - straightens your lower leg at the knee
• Hamstrings - flexes your lower leg at the knee
## Using Gait Assist for Mobility
When you have programmed each available
muscle to your satisfaction, initiate walking. The
animation will reflect the movement of your leg and
symbols next to the animation will turn on and off
at the same time that stimulation is delivered to
each muscle group.
• To activate stimulation, start walking.
• To stop stimulation, press the Pause button.
• To exit Gait Assist, press the Stop button after
pausing.
• To adjust the intensity of all muscles at the
same time, press and hold the horizontal slider
and move it left (lower) and right (higher).
• To change the parameters of a specific muscle
group after stimulation has been activated,
select the muscle at the bottom of the screen
and adjust accordingly.
**WARNING: during the calibration and**
**setup process, the slider intensity is**
**always set at 100%**
Figure 18 | Gait Assist Mode
---
## Neural Sleeve
## Using Exercise Programs
Exercise programs are designed to help improve your walking by conditioning one or more muscles in your
leg. The Neural Sleeve delivers electrical stimulation in a coordinated pattern using parameters you have
defined. To start, select one of the programs to exercise.
Follow the instructions in the app to program the strength of stimulation.
Finally, choose the example to perform and follow the on-screen instructions. Observe that the number
under the right arrow button counts down from 3 during the movement and relax phases.
If you leave the CIONIC App during a program, stimulation will continue. When returning to the CIONIC App,
the on-screen instructions will refresh when you proceed to the next repetition.
| EXERCISE MODE | STIMULATION USED? | DESCRIPTION |
| --- | --- | --- |
| Muscle Activated Stimulation | Yes | This exercise uses stimulation to reinforce muscle activity. |
| Timer Activated Stimulation | Yes | This exercise provides timed stimulation to increase strength. |
| Biofeedback | No | This exercise measures muscle activity without stimulation. An activity meter displays the strength of each contraction. |
---
## Restore FES Settings from a Past Activity
The CIONIC App allows you to restore Functional Electrical Stimulation (FES) settings for activities you have
performed, in the past 30 days, both for Assist or Exercise programs. This feature lets you replicate optimal
settings for specific activities based on your past experiences. Follow the steps below to restore FES
settings for a desired activity:
## Step 1
Navigate to the History Screen:
Begin by accessing the History
screen in the app by tapping on
the History item from the main
menu.
## Step 2
Scroll to Activity Details:
In the History screen, scroll
through the list of recorded
activities under the graphs.
**Step 3**
Scroll to the Desired Activity:
Identify the activity from
which you wish to restore FES
settings. Tap on this activity
to open its detailed view.
---
## Step 4
Restore Specific Settings:
To restore the FES settings for
this activity, locate the “Repeat”
button in the top right corner of
the Activity Details screen.
## Step 5
Tap the “Repeat” Button:
Tap on the “Repeat” button.
This action prompts a dialog
box to appear, confirming
your intention to restore the
settings.
## Step 6
Confirm Restoration:
In the dialog box that appears,
confirm that you wish to
restore the FES settings
by tapping the appropriate
confirmation button.
After confirming, the Cionic Neural Sleeve will apply the saved FES parameters from the selected activity to
your next session.
By following these steps, you can easily restore FES settings from past activities to optimize your experience
with the Cionic Neural Sleeve for various assist programs and exercises. This feature ensures consistent
and tailored stimulation based on your preferred parameters.
---
## Daily Maintenance and Storage
• Carefully examine each electrode pad and each additional component for wear or damage.
• Always replace any electrode pad that appears to be old, worn, lacking adequate adhesive or damaged.
• Be sure that the storage covers are fully covering all electrode pads on all the corresponding sections
of the Neural Sleeve.
• Make sure the Control Unit is detached when the Neural Sleeve is not in use.
• When not in use, store the Neural Sleeve in the plastic bag provided.
• After each use, be sure the Neural Sleeve Control Unit is not plugged in to the sleeve.
• Fully charge the Control Unit between each use.
• In case you don’t have the plastic bag provided with the sleeve, you can store the sleeve, when not in
use, in a regular ziploc bag. This will prevent the electrode pads from drying out prematurely.
## Charging
In order to work properly, it is important to ensure the Neural Sleeve is fully charged before each use.
• Connect the charging cord (provided) to the small plug at the end of the Control Unit.
• Confirm the light is pulsing orange to confirm it is charging. The Neural Sleeve is fully charged when the
indicator light has a solid green display and/or the CIONIC App’s Device Menu shows a battery level of
100% when connected to the Control Unit.
## Replacing the Neural Sleeve Electrode Pads
For regular daily Neural Sleeve at-home users, the
electrode pads should be replaced at least every
four weeks.
The electrode pads need to be removed to clean
the Neural Sleeve. It is recommended that you
clean your Neural Sleeve whenever you change
electrode pads.
To reorder electrode pads please visit the Help
section in the CIONIC App.
**CAUTION: Use only the Neural Sleeve**
**electrode pads supplied by CIONIC.**
**The Control Unit should be unplugged from**
**the Neural Sleeve before putting on or**
**removing the sleeve and before removing**
**or replacing any electrode pads.**
**Never use Neural Sleeve without electrode**
**pads.**
**Verify electrode pads are not expired prior**
**to use.**
---
## Neural Sleeve
Figure 21 | Change Electrode Pads
• Control Unit should be unplugged from the
Neural Sleeve.
• Gently pull off and discard all 24 electrode
pads, or only those that have been identified
as worn or damaged. Ensure the electrode
metal discs are not removed and fabric is not
torn (Figure 21).
• If cleaning is necessary, refer to cleaning
instructions below.
• Refer to the section, “Apply Electrode Pads to
the Neural Sleeve” for instructions on how to
replace electrode pads.
Gel Buildup
**CAUTION: you may notice a dark orange**
**buildup on the buttons. This is caused**
**by the gel that sticks on the button and**
**might reduce effectiveness. In order to**
**remove the buildup, you can wipe the**
**buttons with cleaning disinfecting wipes.**
**If you experience difficulties trying to**
**remove the gel buildup from the button,**
**try to dampen the button and leave it for**
**a few minutes before trying to wipe it**
**again.**
**This operation can be done even without**
**replacing the electrode pad by just**
**carefully removing the pad and reapplying**
**it after cleaning the buildup.**
**WARNING: never use abrasive tools or**
**chemicals to clean the buttons as they**
**might remove the metal protective coating**
**and cause the button to rust.**
---
## Cleaning the Neural Sleeve
It is recommended you clean your Neural Sleeve
every time the electrode pads are replaced.
• Make sure to remove all electrode pads from
the Neural Sleeve.
• Verify that the Control Unit is unplugged and
removed from the pocket of the Neural Sleeve.
• Place the Neural Sleeve on a table with the
flaps open so that the metal discs are visible.
• Use a clean cloth with rubbing alcohol to wipe
down the area where the electrode pads have
been removed, including the metal buttons, to
remove any residue. We recommend cleaning
the Neural Sleeve using a solution of 50%
isopropyl alcohol, 50% water. A commercial
antibacterial spray can also be used, though it
may cause irritation for sensitive skin.
• Allow electrode panel(s) to air dry before
replacing the electrode gel pads
• If you are only replacing a few electrode
pads, prevent contact between alcohol spray
and remaining electrode pads by using the
protective covers during the cleaning process.
• In areas where gel pads are not changed as
regularly, it is recommended to change them
out and clean the area at least once every 2
months.
• For more information, visit support.cionic.
com
**CAUTION: Avoid spraying the cable**
**connector. If the connector gets wet, use a**
**clean, dry cloth to wipe the moisture off until**
**fully dried.**
**CAUTION: Do not use flammable liquids**
**or solvents to clean the Neural Sleeve or**
**Control Unit.**
---
## Taking Care of Your Skin
Taking care of your skin is key to preventing skin irritation and breakdown as well as extending the life of
your hydrogel electrode pads. In the evening, once you have finished using your sleeve for the day, please
cleanse your skin with a gentle cleanser and pat dry. Immediately following, moisturize your skin with lotion
and leave the lotion to absorb into your skin overnight. There is no need to cleanse your skin of the lotion
in the morning unless there is excess on the surface of your skin. In addition to this daily routine, please
gently exfoliate your skin 2–3 times a week, also removing any excess hair. Please do not exfoliate or shave
immediately before using the sleeve—these steps are best completed during the cleansing process and
before applying lotion to your skin.
If you notice any skin irritation, please discontinue use of the sleeve until your skin has healed. You may
need to decrease overall wear time to prevent further skin irritation. If you continue to have skin breakdown
or a rash with use of the sleeve, please consult your Physician for possible treatment options.
---
## Upgrade Your Neural Sleeve Firmware
## Before you start:
Make sure the latest version of the CIONIC App is
installed on your phone. If you are not sure, you can
open the App Store app on your phone and search
for “CIONIC”. Once you are on the CIONIC App page,
the button next to the icon should say “OPEN”. If the
button instead reads “UPDATE” tap on the button to
update to the latest version.
**CAUTION: In order to proceed with the**
**upgrade, your Control Unit needs to be**
**plugged in to your Neural Sleeve.**
!
Figure 22 | iOS App Store
**CAUTION: Make sure your Control Unit has**
**at least 30% battery before starting the**
**upgrade process.**
Figure 23 | Google Play Store
In order to upgrade your Neural Sleeve with the latest firmware available
follow the instructions below:
**Step 1**
From the Home screen in the
CIONIC App, tap the Control Unit
icon at the top right.
**Step 2**
Tap on the “Settings” icon of your
Control Unit.
**Step 3**
Tap on “Start Firmware Upgrade”
from the menu at the bottom of
the screen.
---
## Neural Sleeve
## Step 4
Tap on the “Check versions” button
to verify if a firmware upgrade is
needed.
## Step 6
## Step 5
If new firmware is available, the app
will download it to your phone...
...and then transfer the firmware
from the phone to the Control Unit.
## Step 7
You are now ready to start by
tapping on the “Start Upgrade”
button.
## Step 8
Wait for the app to upgrade all
the components of the Neural
Sleeve...
...until you see the “Done” button at
the bottom of the screen. Tap on
“Done” to exit.
## Step 9
---
## If Your Neural Sleeve Doesn’t Need to be Upgraded
If your Neural Sleeve firmware is already up to
date, you will be notified with a dialog box after
step 4 of the upgrade process. In that case just tap
on the “OK” button and then on the “Done” button
at the bottom of the screen to exit the process.
## Errors While Upgrading
During the firmware upgrade process you might
encounter some errors, in that case please be
sure to do the following:
• Make sure your Control Unit is plugged in to the
Neural Sleeve.
• Make sure your Control Unit has at least 30%
battery.
• Restart the upgrade process by following
the instructions in the “Upgrade Your Neural
Sleeve Firmware” section above.
• If the error persists, take note of the error
message and use the contact button in the
Help screen to notify CIONIC.
Figure 24 | No Upgrade Needed
---
## Verify Your Firmware Version
In order to verify the firmware version installed on your Neural Sleeve, follow the instructions below:
## Step 1
From the Home screen in the CIONIC App,
tap the Control Unit icon at the top right.
## Step 3
## Step 2
Tap on “Get version info” from the
menu at the bottom of the screen.
Tap on the “Settings” icon of your
Control Unit.
**Step 4**
The Firmware version installed will be
visualized in a dialog box. Press OK to dismiss.
---
If you have any questions or concerns about your
Neural Sleeve System, contact CIONIC at
support@cionic.com
## Control Unit fails Adherence Check
Check and make sure all electrodes are applied
correctly to your sleeve. Check and make sure that
all electrode pads are fully adhered to your skin.
## Control Unit is Not Visible in Your CIONIC App
Make sure the device is charged and turned on.
Make sure your Control Unit is within range of your
mobile device. If you were instructed to operate a
factory reset, make sure to press the button on the
Control Unit to start pairing mode. See Connecting
the CIONIC App to the Control Unit for the first
time.
## Control Unit is Unable to Pair with Your CIONIC App
Go into settings under Bluetooth®, identify your
Control Unit serial number and “forget” the device.
Reattempt pairing process in the CIONIC App. See
Factory Reset.
## If You Feel a Sharp, Uncomfortable Pain
Check to see that each electrode is fully flat so
that the entire surface is on your skin. Verify that
the skin under the electrodes is not irritated or has
open wounds
## Stimulation Feels Uncomfortable
Enter FES settings in the Exercise or Assist mode
and adjust stimulation parameters.
## Factory Reset
In rare cases, and only when instructed by a
CIONIC technician, it may be necessary to reset
your Control Unit to the original factory settings. To
perform a factory reset, plug your Control Unit to
the charger and wait for the LED indicator to start
blinking.
With the Control Unit on, press and hold the button
for 10 seconds. When the LED indicator starts
flashing red, press the button again to start the
factory reset process.
After performing a factory reset on your device,
you will need to pair the control unit with your
phone again to ensure proper functionality. Refer
to the section “Connecting the CIONIC App to the
Control Unit for the first time” in CHAPTER 6 of this
manual to know how.
## Control Unit Battery Maintenance Disposal
The Control Unit has a rechargeable battery
that is not removable. Do not attempt to replace
the battery. Maintain a routine of daily charging
if using the system regularly, and at minimum,
once monthly if your system is in storage. Avoid
leaving your Control Unit uncharged indefinitely to
minimize the risk of decreased battery longevity.
Refer to the technical specifications section in
this document for appropriate operating and
storage conditions. The Control Unit battery can
be expected to last several years when maintained
accordingly. For support with your device contact
support@cionic.com or under “report an issue” in
the CIONIC App.
## Disposal
Disposal of the Control Unit, which contains a
Lithium Polymer battery, must be performed
in accordance with local regulations. Improper
disposal presents a hazard to the environment.
---
## CHAPTER 12 | Technical Specifications
**CHAPTER 12 |** Technical Specifications
| Classification | Internally powered, continuous operation with Type BF applied parts |
| --- | --- |
| Power Source(s) | Lithium Polymer (LiPo) rechargeable 7.4V 1900mAh |
| Controls | Single button |
| Indicators | Single LED indicator |
| Operating Modes | Exercise & Assist |
| Number of Output Channels | 1 stimulator channel with 8 virtual Positive output channels and 15 virtual Negative output channels |
| Number of EMG(input) Channels | 8 |
| EMG Sampling Rate | 2kHz |
| EMG detection(Bipolar/Monopolar) | Bipolar |
| Waveform(e.g., pulsed monophasic,biphasic) | Pulsed Monophasic with hybrid stimulation |
| Regulated Current or Regulated Voltage | Regulated Current |
| Charging System | Medical Class II Power AdapterInput:100-240V~50/60HzOutput:5V 2A using USB-C cable |
| Weight | Control Unit(DC-100):145gSleeve(SL-100):S2230g,S4240g,S6250g |
| Dimensions[WxH] | Control Unit(DC-100)137x53x24mmSleeve(SL-100)S252x61cm,S458x63cm,S669x68cm |
| Waveform | Pulsed Monophasic with hybrid stimulation |
| Shape | Rectangular |
| Maximum Output Voltage | 135V |
| Maximum Output Current | 100mA@500Ω,65mA@2kΩ,13mA@10kΩ |
| Current | 0 to 100mA at 5mA increments |
| Pulse Width | 100 to 400μs at 100μs increments |
| Frequency | 5-100 Hz at 5 Hz increments |
| Maximum Intensity | 24.6mA(rms) |
| Maximum Load | Maximum load:300Ω |
| Minimum Load | Minimum load:22kΩ |
| Sizes | S2,S4,S6 |
| Materials | Control Unit(DC-100):Injection Molded Plastic(medical grade polycarbonate(Makrolon))with encased electrical componentsSleeve(SL-100):84% Polyester16% Lycra*Sleeve(SL-100) Sensors:Injection Molded Plastic(medical grade polycarbonate(Makrolon))with encased electrical components |
| Environmental Ranges | Transport and storage temperature:-4°F to +140°F(-20°C to+45°C)Operating conditions temperature:41°F to 104°F(5°C to40°C)Charging temperature:41°F to 104°F(5°C to40°C) |
| | Relative humidity:10% to 75%Operating humidity:15% to 93%Shipping pressure:20kPa to 106kPaOperating pressure:70kPa to 106kPa |
$$
4 0 0 \mu s
$$
$$
-4^{\circ}{\sf F}
$$
$$
+140^{\circ}\mathsf{F}
$$
$$
(-20^{\circ}\mathrm{C}
$$
$$
+ 4 5 ^ {\circ} \mathrm {C})
$$
$$
1 0 4 ^ {\circ} \mathrm {F} (5 ^ {\circ} \mathrm {C}
$$
$$
1 0 4 ^ {\circ} \mathrm {F} (5 ^ {\circ} \mathrm {C}
$$
$$
40^{\circ}\mathrm{C})
$$
$$
40^{\circ}\mathrm{C})
$$
---
| REF | Product part number |
| --- | --- |
| | Caution, Warning, Danger, Important. Refer to accompanying Instructions for Use |
| | Serial Number |
| | Type BF Applied Part |
| | Date of manufacture |
| | Manufacturer |
| | This product must not be disposed of with other household waste |
| | Non-ionizing radiation |
| | Product is non-sterile |
| Rx ONLY | This product is available by prescription only |
| | FCC Registered Product |
| IP22 | Degree of Ingress Protection |
| | Do not wash |
| | Do not dry clean |
| | Do not tumble dry |
| | Follow Instructions for Use |
| | This product needs to be protected from moisture |
| | Range of humidity to which the medical device can be safely exposed |
| | Indicates the temperature limits to which the product can be safely exposed |
| | Range of atmospheric pressure to which the medical device can be safely exposed |
| | Double Insulated (Equivalent to Class II of IEC 61140) |
| | Single Patient Use To Prevent Cross Contamination |
---
## CHAPTER 14 | Wireless Information
| Description | Industry-standard Bluetooth® Low Energy(BLE)5.0 communication protocol |
| --- | --- |
| FCC ID Number | 2A3NPDC100 |
| Operating Frequency Band | 2.4Ghz, ISM band(2.402-2.480GHz) |
| Type of Modulation | FSK |
| Type of Modulating Signal | Binary data message |
| Data Rate[=Frequency of Modulating Signal] | 1Mbps |
| Effective Radiated Power | <10dBm |
| Receiver Bandwidth | 2.4Ghz,ISM band(2.402-2.480GHz) |
| EMC Testing | Complies withFCC15.2473(forU.S.)regulationsComplies withIEC60601-1-2Complies withIEC60601-2-10 |
**Wireless Quality of Service (QoS):** The Cionic Neural Sleeve NS-100 System was designed and tested to
have an average response rate of 30-150 ms latency depending on system configuration.
**Wireless Interference:** The Neural Sleeve NS-100 System was designed and tested to not have interference
from other RF devices (including other Neural Sleeve NS-100 Systems, WiFi networks, Cellular Devices, Microwaves
®
and other Bluetooth devices).
The Neural Sleeve NS-100 System is not susceptible to the wide range of expected EMI emitters, such as Electronic
Article Surveillance Systems (EAS), Radio Frequency Identification Systems (RFID), Tag Deactivators, and Metal
Detectors. However, there is no guarantee that interference will not occur in a particular situation.
**Caution:** If performance of the Neural Sleeve NS-100 System is affected by other equipment, the user should turn
the Neural Sleeve NS-100 System off, and move away from the interfering equipment.
## Electromagnetic Compatibility (EMC) Information
Guidance and Manufacturer’s Declaration—Electromagnetic Emissions
The Neural Sleeve NS-100 System is intended for use in the electromagnetic environment specified
below. The user of the Neural Sleeve NS-100 System should assure that it is used in such an environment.
| Emissions Test | Compliance | Electromagnetic Environment- Guidance |
| --- | --- | --- |
| RF emissions CISPR 11 | Group 1 | The Neural Sleeve NS-100 System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. |
| RF emissions CISPR 11 | Class B | The Neural Sleeve NS-100 System is suitable for use in all establishments, including domestic establishments those directly connected to the public supply network that |
| Harmonic emissionsIEC61000-3-2 | Class A | The Neural Sleeve NS-100 System is suitable for use in all establishments, including domestic establishments those directly connected to the public supply network that |
| Voltage fluctuations/ flicker emissionsIEC61000-3-3 | Complies | The Neural Sleeve NS-100 System is suitable for use in all establishments, including domestic establishments those directly connected to the public supply network that |
---
## Wireless Information CHAPTER 14 |
## CHAPTER 14 | Wireless Information
**Guidance and Manufacturer’s Declaration— Electromagnetic Immunity for All Equipment and Systems**
The Neural Sleeve NS-100 System is intended for use in the electromagnetic environment specified below. The customer or the
user of the Neural Sleeve NS-100 System should assure that it is used in such an environment.
| Immunity Test | IEC 60601 Test Level | Compliance Level | Electromagnetic Environment- Guidance |
| --- | --- | --- | --- |
| Electrostatic discharge (ESD) IEC 61000-4-2 | +/-8kV contact +/-15kV air | +/-8kV contact +/-15kV air | Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least30% |
| Electrical fast transient/ burst IEC 61000-4-4 | +/-2kV for power supply lines +/-1kV for Input/ output lines | +/-2kV for power supply lines | Mains power quality should be that of a typical commercial or hospital environment. |
| Surge IEC 61000-4-5 | +/-1kV line to line +/-2kV line to earth | +/-1kV line to line +/-2kV line to earth | Mains power quality should be that of a typical commercial or hospital environment. |
| Voltage dips, short interruptions, and voltage variations on power supply input lines IEC 61000-4-11 | <5% UT(>95% dip in UT) for0.5cycle40% UT(60% dip in UT)for5 cycles70% UT(30% dip in UT)for25 cycles<5% UT(>95% dip in UT)for5 sec | <5% UT(>95% dip in UT) for0.5 cycle40% UT(60% dip in UT)for5 cycles70% UT(30% dip in UT)for25 cycles<5% UT(>95% dip in UT)for5 sec | Mains power quality should be that of a typical commercial or hospital environment.If the user of the Neural Sleeve NS-100 System requires continued operation during power mains interruptions, it is recommended that the equipment be powered from an uninterrupted power supply or a battery. |
| Power frequency(50/60Hz) magnetic field IEC 61000-4-8 | 30A/m | 30A/m | Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. |
## Guidance and Manufacturer’s Declaration—Electromagnetic Immunity
The Neural Sleeve NS-100 System is intended for use in the electromagnetic environment specified below. The customer or the
user of the Neural Sleeve NS-100 System should assure that it is used in such an environment.
| Immunity Test | IEC 60601 Test Level | Compliance Level | Electromagnetic Environment- Guidance |
| --- | --- | --- | --- |
| | | | Portable and mobile RF communications equipment should be used no closer to any part of the Neural Sleeve NS-100 System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter |
| Conducted RF IEC 61000-4-6 | 3 Vrms 150 kHz to 80 MHz6 Vrms ISM and Amateur Radio Bands | 3 Vrms 150 kHz to 80 MHz6 Vrms ISM and Amateur Radio Bands | Recommended separation distance:d=1.2VP |
| Radiated RF IEC 61000-4-3 | 10 V/m 80 MHz to 2.7GHzProximity Fields per60601-1-24th edition | [E1]=10 V/m in 26MHz to2.7GHzProximity Fields per60601-1-24th edition | Recommended separation distance:d=0.4V,P,80-800MHz ranged=0.7V,P,800-2700MHz range |
| Note1:At80MHz和800MHz,the higher frequency range applies.
Note2:These guidelines may not apply in all situations.Electromagnetic propagation is affected by absorption and reflection from structures,objects,and people.
Note3:P is the maximum output power rating of the transmitter in watts(W) according to the transmitter manufacturer and d is the recommended separation distance in meters(m).
Note4:Field strengths from fixed RF transmitters,as determined by an electromagnetic site survey,should be less than the compliance level in each frequency range.
Note5:Interference may occur in the vicinity of equipment marked with the following symbol:a)Field strengths from fixed transmitters,such as base stations for radio(cellular/cordless)telephones and land mobile radios,amateur radio,AM and FM radio broadcast,and TV broadcast cannot be predicted theoretically with accuracy.To assess the electromagnetic environment due to fixed RF transmitters,an electromagnetic site survey should be considered.If the measured field strength in the location in which the Neural Sleeve NS-100 System is used exceeds the applicable RF compliance level above,the Neural Sleeve NS-100 System should be observed to verify normal operation.If abnormal performance is observed,additional measures may be necessary,such as re-orienting or relocating the Neural Sleeve NS-100 System.b)Over the frequency range150kHzto80MHz,field strengths should be less than3V/m. | | | |
$$
(((\bullet)))
$$
---
## Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Neural Sleeve NS-100 System
This device can be used under the environment that radiated RF disturbances are controlled. User should
maintain a minimum distance between portable and mobile RF communications equipment to prevent
electromagnetic interference. Following recommended distance is calculated according to the maximum
output power of the communication equipment.
| Rated Maximum Output Power of Transmitter(W) | Separation Distance According to Frequency of Transmitter | | |
| --- | --- | --- | --- |
| Rated Maximum Output Power of Transmitter(W) | 150kHz to 80MHz Outside ISM Bandsd=1.2√P | 80MHz to 800MHzd=1.2√P | 800MHz to 2.7GHzd=2.3√P |
| 0.01 | 0.12m | 0.04m | 0.07m |
| 0.1 | 0.38m | 0.13m | 0.22m |
| 1 | 1.2m | 0.4m | 0.7m |
| 10 | 3.8m | 1.3m | 2.2m |
| 100 | 12m | 4m | 7m |
| For transmitters rated at a maximum output power not listed above,the recommended separation distance“d”in meters(m)can be determined using the equation applicable to the frequency of the transmitter,where“P”是the maximum output power rating of the transmitter in watts(W) according to the transmitter manufacturer.
Note1:At80MHz和800MHz,the higher frequency range applies.
Note2:These guidelines may not apply in all situations.Electromagnetic propagation is affected by absorption and reflection from structures,objects,and people。 | | | |
---
Notes
50 | Cionic Neural Sleeve Instructions for Use
---
CIONIC
Neural Sleeve
---
## Clonic
Superpowering
the Human Body