EXOPULSE Mollii Suit User manual

EXOPULSE Mollii Suit User Manual rev. 5.00
User Manual
English
This user manual (version 5.00 EN) was produced
by EXONEURAL NETWORK AB and applies to EXOPULSE Mollii Suit
(EXOPULSE Mollii Control Unit version 9.3).
The operating instructions are valid from 22-02-2023.
Firmware version (EXOPULSE Mollii Control Unit):1.3x
EXONEURAL NETWORK AB, Barks väg 7, 170 73 Solna, Sweden
Phone: [phone]

EXOPULSE Mollii Suit User Manual rev. 5.00
TABLE OF CONTENT
1. HOW TO USE THE EXOPULSE Mollii Suit IN EIGHT STEPS
STEP 1 READ THE INTENDED USE AND SAFETY INSTRUCTIONS
CAREFULLY ..................................................... 1
STEP 2 CHECK THAT THE SET IS COMPLETE........................ 6
STEP 3 INSERT BATTERIES ............................................. 7
STEP 4 DRESSING UP.................................................... 8
STEP 5 ATTACH THE CONTROL UNIT ...............................11
STEP 6 START A 60-MINUTE EXOPULSE Mollii SUIT SESSION ...14
STEP 7 END THE EXOPULSE Mollii SESSION ........................14
STEP 8 CLEANING AND STORAGE ....................................15
2. TROUBLESHOOTING SECTION ...........................................16
3. REPORTING FAULTS AND INCIDENTS...................................17
4. ELECTRICAL NERVE AND MUSCLE STIMULATION.....................18
5. TECHNICAL DESCRIPTION ................................................19
6. TABLE DATA AND STANDARDS ..........................................21
7. SYMBOLS....................................................................23

EXOPULSE Mollii Suit User Manual rev. 5.00
1. HOW TO USE THE
EXOPULSE Mollii Suit IN
EIGHT STEPS

EXOPULSE Mollii Suit User Manual rev. 5.00
1
READ THE INTENDED USE AND SAFETY
INSTRUCTIONS CAREFULLY
EXOPULSE Mollii Suit is a personal assistive medical device which is used for low energy whole
body transcutaneous electrical stimulation - 20 Volt and 20 Hz. It is composed of a control unit, a
jacket and pants with 58 embedded electrodes, in direct contact with the skin. The suit can be
used by children or adults and comes in sizes starting from 104 cm up to 5XL men and women.
It is prescribed by a health-care practitioner based on a clinical assessment.
INTENDED USE
The EXOPULSE Mollii Suit consists of the EXOPULSE Mollii Control Unit and EXOPULSE Body
Garments (Jacket and Pants).
EXOPULSE Body Garments (Jacket and Pants)
The EXOPULSE Body Garments (Jacket and Pants) is a suit with embedded electrodes,
conductive wires and connectors to a detachable control unit, who’s intended purpose is to
transmit electric pulses from the control unit to key nerves and corresponding muscle groups
throughout the body.
EXOPULSE Mollii Control Unit
The EXOPULSE Mollii Control Unit is a battery powered electrical device which sends low energy
electric pulses through connectors to the EXOPULSE Body Garments which in turn transmits the
pulses from the connectors to key nerves and corresponding muscle groups throughout the body.
The intended use of EXOPULSE Mollii Suit is:
• Relaxation of tense and spastic muscles
• Activation of muscles
• Increasing local blood circulation
• Symptomatic relief of chronic pain
EXOPULSE Mollii Suit is for use in the home and clinical environment.
INTENDED PURPOSE
The EXOPULSE Mollii Suit is intended to provide: relaxation of tense and spastic muscles and
muscle activation, improved local blood circulation and pain relief in patients with CP, MS, stroke
and other neurologic disorders which may cause such type of symptoms; together with: pain relief
in patients with fibromyalgia, and other neurologic disorders which may cause such type of
symptoms.
It is intended to be used for 60 minutes every other day, unless otherwise specified by your
healthcare provider, in the home environment and clinical environment.
STEP

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MODE OF ACTION
EXOPULSE Mollii Suit is used for activation of muscles or relaxation of spastic muscles mediated
by a physiological reflex mechanism referred to as reciprocal inhibition. By sending an electrical
signal to an antagonistic muscle, the spastic muscle may subsequently relax. EXOPULSE Mollii
Suit is also used for management of chronic pain, mediated by selectively stimulating the nerve
fibers carrying non-pain sensory stimuli from a specific region, which may reduce the effect of
pain signals.
CONTRAINDICATIONS
Do NOT use:
• If the user has implanted electronic medical devices or equipment which can be
disrupted by magnets, for example, shunts;
• Together with electronic life-support equipment or high-frequency operation equipment;
• Together with ECG-equipment.
There is a risk that the EXOPULSE Mollii Suit can disturb the function of the aforementioned
types of equipment.
Stimulation should NOT be applied:
• Over swollen, infected, or inflamed areas or skin eruptions e.g., phlebitis,
thrombophlebitis, varicose veins, etc.;
• Over the neck or mouth. Severe spasm of the laryngeal and pharyngeal muscles may
occur and the contractions may be strong enough to close the airway or cause difficulty
in breathing;
• Transthorically in that the introduction of electrical current into the heart may cause
cardiac arrhythmias;
• Transcerebrally.
WARNINGS – Indicates a hazardous situation that, if not avoided, could result in death or serious
injury.
EXOPULSE Mollii Suit may only be used by, or under the supervision of, a person who has read
and understood the entire user manual.
Do not use EXOPULSE Mollii Suit without consulting a doctor in connection with:
• Cardiovascular diseases or other types of related conditions
• Malignancy (cancer)
• Infectious diseases
• Fever
• Epilepsy
• Skin disease, rashes or other skin problems
• Usage together with another medical device.

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Usage in connection with the above can expose the user to unnecessary risk and is therefore at
the user's own risk. Always consult a doctor.
EXOPULSE Mollii Suit should NOT be used while driving, operating machinery, or during any
activity in which involuntary muscle contractions may put the user at undue risk of injury.
EXOPULSE Mollii Suit should not be serviced while in use.
Do NOT modify EXOPULSE Mollii Suit.
Do NOT use EXOPULSE Mollii Suit outdoors, in wet rooms, in direct sunlight, or in connection
with flammable materials/liquids. Keep away from dusty, damp and bright environments to avoid
damage or harm to the EXOPULSE Mollii Suit.
Do NOT use the EXOPULSE Mollii Suit near a M.R.I (Magnetic Resonance Imager).
CAUTIONS – Indicates a hazardous situation that, if not avoided, could result in minor or
moderate injury.
Caution should be used in the presence of the following:
• When there is a chance of hemorrhaging following acute trauma of fracture;
• Following recent surgical procedures. Muscle contractions may disrupt the healing
process;
• During menstruation or pregnancy;
• Over areas of the skin which lack normal sensation.
Use of this equipment adjacent to, stacked with or interconnected to other equipment should be
avoided because it could result in improper operation. If such use is necessary, this equipment
and the other equipment should be observed to verify that they are operating normally.
Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of EXOPULSE Mollii Suit could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in improper operation.
Portable radio frequency communications equipment (including cell phones, computers and
peripherals such as antenna cables and external antennas) should be used no closer than 30
cm (12 inches) to any part of the equipment, including cables specified by the manufacturer.
Therapeutic equipment that transmits micro-waves or short waves should be used no closer than
1 m (39 inches) to any part of the equipment. Otherwise, this could result in the degradation of
the performance of the equipment.

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Remove all batteries if EXOPULSE Mollii Suit is not going to be used for three weeks or more,
to avoid the risk of battery leakage and corrosion.
Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation
or electrically conductive medium. The irritation can usually be reduced by using an alternate
conductive medium, or alternate electrode placement. Electrode placement and stimulation
settings should be based on the guidance of the prescribing practitioner.
The EXOPULSE Mollii Suit is for use solely by the user for whom it is programmed.
Take care when children and pets are present to avoid damage to the EXOPULSE Mollii Suit.
Avoid contact with all substances and chemicals found in the home environment, except for water
or body lotion used to moisture the skin.
Spilling liquid on the EXOPULSE Mollii Suit can cause discomfort. Drinks and liquids should be
avoided during use. The garment should not be used when the garment or control unit is wet or
damped and should immediately be turned off in such circumstances.
Ensure that the magnetic couplings are correctly positioned (see STEP 5.)
Ensure that the magnetic coupling (in garment and control unit) does not come into contact with
devices that can be destroyed by magnets.
Jewelry, accessories (in contact with the garment) and underwear with metal buckles should not
be used together with EXOPULSE Mollii Suit.
Never insert objects or tools under the garment.
Do not use EXOPULSE Mollii Suit if the control unit has visible marks or is damaged. Always
check that the EXOPULSE Mollii Suit is intact, dry and clean before use, and make sure to wash
the garment before using it for the first time.
Wearing EXOPULSE Mollii Suit can cause sweating and dehydration, especially when worn in
humid and warm conditions. Drink sufficient fluids in order to avoid dehydration.
Take care when using EXOPULSE Mollii Suit. Bear in mind that, for example, balance may be
affected. Do not undertake demanding or heavy physical exercise when using EXOPULSE Mollii
Suit.

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Electrotherapy can make the user tired and drowsy. Do not undertake activities which require
intense concentration if feeling tired or drowsy.
Follow the instructions for cleaning the garment and electrodes in STEP 8.
Regular contact with electrodes can irritate or chafe the skin. It is therefore particularly important
to maintain good hygiene and to ensure:
• That the electrodes are clean and in good contact with the skin.
• To wash the skin every day with soap and water.
• To moisturize the skin with unscented skin lotion.
• Never to use EXOPULSE Mollii Suit if there the skin is dry, sore, irritated or injured.
The magnetic arms on the control unit must be handled with care, and:
• Must not be forcefully removed, but lifted from their respective magnetic coupling, one
at the time,
• Must not be twisted when connected to the suit, and
• Must not be bent to from sharp angles, but instead must allow ample curves.
The magnetic arms should be tested for wear and tear once per year and replaced if faulty. In
addition to that, in case of loosened components and/or if effect is absent and/or decreased,
please contact your local EXONEURAL NETWORK AB partner. The replacement must only be
done by an approved personnel, and will be covered by the product warranty, provided that the
product has been handled according to instructions contained herein.
Do not use carbon-zinc AAA batteries as they have reduced hours of use and provide high risk
of leaking. Damage due to use of these batteries may void warranty.
ADVERSE REACTIONS
Skin irritation and burns beneath the electrodes have been reported with the use of
transcutaneous electrical stimulators.

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CHECK THAT THE SET IS COMPLETE
EXOPULSE Body
Garments jacket*
EXOPULSE Mollii Control
Unit supplied with a belt*
EXOPULSE Body
Garments pants*
Laundry bag x2
* Note: Jacket, pants and control unit have unique item numbers.
STEP

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INSERT BATTERIES
Alkaline AAA batteries are acceptable for use.
OPEN BATTERY COVER
Place the control unit with the screen facing down. Pull the belt away to uncover the battery
cover. Use a Phillips head screwdriver to undo the 4 screws on the rear of the control unit and
remove the rear cover.
INSERT BATTERIES
Insert 4 x AAA batteries according to the polarities indicated in each battery socket. Always check
that + and – poles are turned in the right direction, using the mini USB as a reference point as
indicated below:
MINI USB SHOULD BE FACING DOWN

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CLOSE BATTERY COVER
Check that no screws or external items have been left behind before replacing the battery cover
in the directions indicated in the battery socket. Screw the cover on firmly using a screwdriver.
CHECK THE BATTERY LEVEL
Turn the control unit on by pressing the ON button. Check the battery level:
Battery full Battery half full Battery low.
Replace batteries
DRESSING UP
FAVOR NARROW UNDERWEAR
Ensure to moisturize your skin with unscented lotion. Choose a narrow pair of underwear to make
sure the underwear is not covering the electrodes on the inside of the garment. Underwear
should be adjusted if they are in the way of the electrodes.
STEP
NARROW
UNDERWEAR
ELECTRODES
AGAINST
SKIN

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OPEN ALL THE PANTS’ ZIPPERS BEFORE DRESSING UP PUT THE PANTS ON
ADJUST THE KNEE-CAP PLACEMENT
Ensure that the seam is above the knee.
CLOSE THE PANTS’ ZIPPERS
CHECK THAT THE ELECTRODES ARE IN CONTACT WITH THE SKIN

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OPEN ALL THE JACKET’S ZIPPERS PUT THE JACKET ON
ENSURE THE JACKET IS OVER THE PANTS
The jacket should be outside the pants. Snap the jacket to the pants with the buttons.
CLOSE THE JACKET’S ZIPPERS
ADJUST THE FOREARMS PLACEMENT
Make sure that the zippers are on the outside of the forearm and form a straight line between
the elbow and the little finger as indicated below:
ELBOW
LITTLE
FINGER
FOREARM
ZIPPER LINE

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ATTACH THE CONTROL UNIT
POSITION THE CONTROL UNIT
Place the control unit on the belly above the hipline and below the waistline with the display
facing away from the belly as indicated below:
CLICK THE BELT AROUND THE WAIST
Click the belt on by vertically sliding the two parts together.
ADJUST THE LENGTH OF THE BELT
STEP
WAIST
LINE
HIP
LINE

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RECHECK THAT THE CONTROL UNIT IS ON
Recheck that the control unit is on. If not, press the ON button.
CAREFULLY CONNECT THE MAGNETIC ARMS
Place the upper left magnetic arm carefully on the upper left connector. If you are experiencing
magnetic repulsing, then you are placing the wrong magnetic arm. Proceed with placing the
upper right magnetic arm on the upper right magnetic connector, and the lower left magnetic arm
on the lower left connector, and finally the lower right magnetic arm on the lower right connector.
Make sure each magnetic arm is correct positioned on each connector, as indicated below.
UPPER-RIGHT
MAGNETIC-
ARM
& CONNECTOR
LOWER-RIGHT
MAGNETIC-
ARM
& CONNECTOR
LOWER-LEFT
MAGNETIC
-ARM
& CONNECTOR
UPPER-LEFT
MAGNETIC
-ARM
& CONNECTOR

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Correct position:
Incorrect positions:

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START A 60-MINUTE EXOPULSE Mollii SUIT
SESSION
Press PLAY/PAUSE button once.
The display shows PLAY and the remaining time counting down from 60 minutes.
If necessary: PAUSE by pressing PLAY/PAUSE once. The display then shows:
Press PLAY/PAUSE again to continue the session.
DURING USE
While using EXOPULSE Mollii Suit, you can remain still, move around or exercise. Check that
each magnetic arm is in the correct position, when moving around. If not, make sure to reposition
it correctly.
EXOPULSE Mollii Suit should not be serviced while in use.
END THE EXOPULSE Mollii SESSION
TURN OFF THE CONTROL UNIT AND REMOVE IT
Turn off the control unit by pressing the ON/OFF button. Remove the control unit carefully, one
magnetic coupling at a time, making sure not to pull or twist the magnetic arms. Always place
the control unit back into the protective box.
OPEN ZIPPERS AND UNDRESS
STEP
STEP

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CLEANING AND STORAGE
REGULAR CLEANING
Rinse the garment in cold water or, wipe off the electrodes using wet wipes. Clean the control
unit, magnetic arms and connectors at least every other month, using a lightly dampened cloth
with no detergent. Do not immerse the control unit in water.
WASHING INSTRUCTIONS
The garment can be hand or machine washed at 40°C/104°F, using delicate wash without
softener. Wash when necessary (at least once every other month) to keep fabric and
electrodes clean. The control unit must be disconnected from the suit before washing. Wash
the garments separately in the two laundry bags supplied. Do not tumble dry or iron.
OPERATING
EXOPULSE Mollii Suit should be operated indoors under the following conditions:
• Temperature 5 to 42°C
• Humidity: 15% to 90% relative humidity
• Altitude: 1,060 hPa to 700 hPa (10,000 ft to -1250 ft)
• Avoid dusty, damp and bright environments
If EXOPULSE Mollii Suit has been exposed to temperatures higher or lower than the operation
temperature, let the device warm up/cool down for at least one hour before use.
TRANSPORTATION AND STORAGE
Temperature: -25 to 70°C
Humidity: 15% to 90% relative humidity
Store the EXOPULSE Mollii Control Unit in the protective box
NOTE: Remove all batteries if EXOPULSE Mollii Suit is not going to be used for three weeks
or more, to avoid the risk of battery leakage and corrosion-this event is not subject to the
warranty.
STEP

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2. TROUBLESHOOTING SECTION
Problem
Possible causes
Solution
No display Low
batteries
OR
Batteries inserted
incorrectly
Replace
batteries
OR
Check instructions in
Section 1 STEP 3
Display
showing the
symbol
The control unit is
unprogrammed
Contact EXONEURAL NET-
WORK AB or your local
reseller
Sudden change in
sensation
OR
Shifting/decreasin
g sensation during
use
Incorrect position of
magnetic arms on the
connectors
OR
Electrodes are not in good
contact with the skin
Verify battery level and
check installation of control
unit and adjust suit according
to instructions in Section 1
STEP 4 and STEP 5.
The skin turns red
or the skin feels
irritated
Dry skin or electrodes are
not in good contact with
the skin
Clean and moisturize the
skin regularly as well as
check installation of control
unit and adjust suit according
to instructions in Section 1
STEP 4 and STEP 5.

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3. REPORTING FAULTS AND INCIDENTS
ACCIDENTS, FAULTS AND SUPORT
If an accident, incident or injury occurs, immediately contact your local distributor. Faulty
equipment must NOT be used.
In case of faults and if this symbol shows up on the screen: , please contact your local
distributor.
For service and repair, or if you need support with your EXOPULSE Mollii Suit, please contact
your local distributor.
SERIOUS INCIDENTS
In case of a serious incident which occurred in relation to the device, report to the (Competent)
Authority of the (Member) State in which you are established and immediately contact:
EXONEURAL NETWORK AB
Barks väg 7
170 73 Solna
Sweden
Phone number: [phone]
e-mail: [e-mail]