EXOPULSE Mollii Suit User manual

Please read through the entire user manual prior to use.
User Manual
EXOPULSE
Mollii Suit

3
is user manual (version 1.55.4 EN) was produced by EXONEURAL NETWORK and applies to EXOPULSE Mollii Suit.
e operating instructions are valid from 31/08/2020.
Soware version: 1.3x
EXONEURAL NETWORK AB, Svärdvägen 11D, SE-182 33 Danderyd, Sweden. Tel: [phone]
User Manual (EN) .................................................................................... 5

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ENGLISH

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Intended use
e intended use of EXOPULSE Mollii Suit is:
- Relaxation of spastic muscles
- Maintaining or increasing range of motion
- Activation and re-education of muscles
- Retardation or prevention of disuse atrophy
- Increasing local blood circulation
- Symptomatic relief and management of chronic intractable pain
- Adjunctive treatment for post-surgical pain
EXOPULSE Mollii Suit is for use in the home environment.
Change of name
EXOPULSE Mollii Suit was previously called Mollii.
EXOPULSE Mollii Suit consists of
EXOPULSE Body Garments (item number: 100-1)
1 jacket and 1 pair of trousers supplied with laundry
bags.
EXOPULSE Control Unit (item number: 100-2)
1 control unit. e control unit can be connected to the
garment unit by means of 4 magnetic couplings. e
control unit is secured around the waist with the belt
supplied.
Item number
Note that every size of jacket and trousers has a unique item number. For a complete list
of item numbers see: www.exopulse.com
EN

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Button: ON/OFF
Turns the control unit on and o
respectively
Symbol: Declaration of conformity
according to the Council Directive
93/42/EEC concerning medical
devices. 0413 is the identication
number for the notied body.
Button: PLAY/PAUSE Symbol: Year of manufacture
Display: If this symbol is visible in
the display, the control unit is in
PLAY mode.
Symbol: Machine wash 40° C,
delicate wash
Display: If this symbol is visible in
the display, the control unit is in
PAUSE mode.
Symbol: Dry at
Display: Product defect – do not
use the product!
Contact EXONEURAL
NETWORK AB if this symbol is
displayed.
Symbol: Do not dry-clean
Display: Battery indicator Symbol: Do not tumble-dry
Symbol: is product is labelled
according to EU Directive 2002/96/
EC (WEEE). e symbol means
that the product must not be
disposed of as domestic waste, but
in a dedicated site for recovery and
reuse of electronics and electrical
waste.
Symbol: Do not iron
Symbol: Patient connection is
classied: BF
Symbol: Do not bleach
Symbol: Read the entire user
manual prior to using EXOPULSE
Mollii Suit.
Symbol: Do not wring out when
drying
Symbols
2013
0413
EN

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CONTRA-
INDICATIONS
Never use EXOPULSE
Mollii Suit:
- 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 EKG-
equipment.
ere is a risk of
EXOPULSE Mollii Suit
disturbing the function
of the above-mentioned
types of equipment.
All incorrect usage is at
the user's own risk.
CAUTION
Do not use EXOPULSE
Mollii Suit without
consulting a doctor in
connection with:
- Cardiovascular diseases
- Malignancy (cancer)
- Infectious diseases
- Fever
- Pregnancy
- Skin disease, rashes or
other skin problems.
- Usage together with
another medical device
or medical treatment.
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 is
for use solely by the user
for whom it is adapted.
Magnetic couplings
(couplings between
control unit and
garment) must not be
lengthened or modied
in any way.
EXOPULSE Mollii Suit
may only be used by, or
under the supervision of,
a person who has read
and understood the user
manual.
Take care when children
and pets are present.
-Ensure that the
magnetic coupling (in
garment and control
unit) does not come into
contact with devices
that can be destroyed by
magnets.
- Treatment with
electrotherapy can
make the user tired and
drowsy.
Spilling liquid on
EXOPULSE Mollii Suit
can cause discomfort.
e garment should
consequently be turned
o if it gets wet, and
drinks and liquids should
be avoided during use.
Jewellery/accessories
should not be
used together with
EXOPULSE Mollii Suit.
Safety instructions
EN

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SAFE USE
- Never insert objects or
tools under the garment.
- Do not use EXOPULSE
Mollii Suit if the control
unit has visible marks or
is damaged.
- Do not use EXOPULSE
Mollii Suit in wet
rooms, direct sunlight
or in connection with
ammable materials/
liquids.
- Do not use EXOPULSE
Mollii Suit if the garment
or control unit is wet or
damp.
- Ensure that the
magnetic coupling is
correctly positioned,
instructions can be found
on page 11.
e user acknowledges
that to the magnetic arms
on the control unit, are
natural wear and tear
parts, which:
- Must be handled with
care.
- Must not be forcefully
removed from the
magnetic couplings
by pulling the control
unit. Instead, each arm
must be lied from their
respective magnetic
coupling, one at the time.
- Must not be twisted
when connected to the
suit, but instead should
remain in the same two-
dimensional plane.
- Must not be bent
abruptly to from sharp
angles, but instead must
allow ample curves.
Following the above
instructions should
prolong the resistance
of magnetic arms to
wear and tear and as
such, should extend
their life expectancy. e
magnetic arms should
be tested for natural tear
and wear once per year,
and replaced if faulty. e
replacement must only
be done by an approved
distributor, and will be
covered by the product
warranty, provided that
the products has been
handled according to
instructions contained
herein.
SKIN CARE
Regular contact with
electrodes can irritate
or chafe the skin. It is
therefore particularly
important to maintain
good hygiene and to
ensure that you:
- wash the skin every day
with soap and water.
- moisturise the
skin frequently with
unscented skin lotion.
- never use EXOPULSE
Mollii Suit if there are
sores on the skin or if it
is irritated or injured.
- follow the instructions
for cleaning.
BEAR IN MIND
EXOPULSE Mollii Suit is
intended to be used for
approx. 60minutes every
other day.
Take care when using
EXOPULSE Mollii Suit.
Bear in mind that, for
example, the balance can
be aected.
Do not undertake
demanding or heavy
physical exercise when
using EXOPULSE Mollii
Suit.
EXOPULSE Mollii
Suit must not be used
outdoors.
Tip: use EXOPULSE
Mollii Suit prior to
outdoor activity - the
eect lasts for up to 48
hours.
CONTACT
EXONEURAL
NETWORK
- If an accident, injury or
incident occurs during
normal use.
- If incorrect use results
in an accident or injury.
- If this symbol comes up
on the display:
EN

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ENVIRONMENT
EXOPULSE Mollii Suit
should be used and
stored indoors.
Temperature: 15 - 35 °C
Atmospheric humidity:
Relative humidity 5% to
95%
Atmospheric pressure:
approx. 1,013 hPa to
844 hPa (0 m to 2,000 m
above sea level)
Keep the surrounding
environment of
EXOPULSE Mollii Suit
clean and dry.
BEAR IN MIND
e ooring material can
aect safety. Read the
instructions on p. 16.
Maintain a minimum
distance of 1 m to radio
frequency equipment or
therapeutic equipment
that transmits micro-
waves or short waves.
DISPOSAL
Please return
EXOPULSE Mollii
Suit to EXONEURAL
NETWORK for disposal.
Please handle used
batteries in accordance
with the WEEE
directive. Seep.7.
BEFORE USE
Ensure that the skin
is clean and free of
cracks or rashes. Wash
EXOPULSE Mollii Suit
before it is used for the
rst time. Always check
that EXOPULSE Mollii
Suit is intact, dry and
clean before use.
AFTER USE
Rinse the whole garment
with cold water or wipe
o the electrodes.
Use baby wipes for this
as they are gentle on the
skin.
REGULARLY
e garment can be
machine washed in a
laundry bag at 40° C,
delicate wash. Wash
regularly (about once
a month) to keep fabric
and electrodes clean.
Clean control unit,
leads and coupling by
wiping o with a lightly
dampened cloth with no
detergent.
A poorly cleaned
garment or dirty skin
can result in eczema or
a rash.
DURABILITY
EXOPULSE Mollii
Suit should last for 25
washes, or 2 years of
regular use. Use over
and above this is not
covered by the warranties
of EXONEURAL
NETWORK.
STORAGE
Keep EXOPULSE Mollii
Suit dry and at room
temperature. Avoid
dusty, damp and bright
environments.
Store and transport
EXOPULSE Mollii Suit in
its original packaging.
Remove all batteries if
EXOPULSE Mollii Suit is
not going to be used for a
period of 3 weeks or more.
TRANSPORT
Temperature:
-20 to 40 °C
Atmospheric humidity:
Relative humidity 5%
to 95%
Atmospheric pressure:
approx. 1,013 hPa to
19hPa (0 m to 12,000 m
above sea level).
SPARE PARTS
Repairs and servicing
must be carried out
by EXONEURAL
NETWORK. Faulty
equipment must not
be used. Contact
EXONEURAL NETWORK
for service and support.
Environment, Storage, Usage
EN

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BATTERIES
Use a crosshead screw-
driver to undo the 4
screws on the rear of the
control unit.
Insert 4 x HR03/AAA
batteries.
Check that no screws
or similar have been le
behind before replacing
the battery cover.
Screw the cover on rmly
using a screwdriver.
It is best to use recharge-
able batteries.
EXOPULSE Mollii Suit
has been tested with
rechargeable batteries
from GP (item number:
100AAAHC).
DRESSING
Always check that EXO-
PULSE Mollii Suit is intact
and clean before use.
Put on both parts of
the garment (jacket and
trousers) and then secure
the belt with the control
unit around the waist.
Connect the magnetic
couplings in accordance
with the picture on the
right. See the next page
for dressing instructions.
e electrodes end up in
the correct position if the
right size is used and the
zips are placed according
to the instructions. Com-
pare with the pictures on
the next page.
CONNECTING THE
CONTROL UNIT
read the belt through
the loops on the back of
the control unit. Secure
the belt around the waist.
Check that the magnet-
ic couplings are intact.
Check that the control
unit is secured correctly
and that nothing is pro-
truding or has got caught
between the magnetic
coupling and the gar-
ment unit.
It is particularly impor-
tant that the magnetic
coupling which is located
closest to the heart is
correctly positioned.
Correct position:
Incorrect position which
exposes the user to risk:
EN

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3. Pull the trousers right up before you do up the side zips and the y.
Dressing
1. Start with the trousers. Ensure that the lower zip ends up on the outside of the leg
and forms a line between the ankle and the outside of the knee.
2. Check that the zips on the trousers form a straight line on the outside of the leg in
accordance with the pictures below.
EN

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5. Check that the zips are positioned as in the picture
on the le.
4. Put the jacket on by inserting one arm at a time.
Ensure that the side zips end up on the outside of the
arm.
7. e shirt should be outside the trousers. Do up the
zip on the stomach rst, then the zips for the arms.
Check that the garment unit is positioned correctly on
the body and the zips are straight.
6. read the belt through the loops on the back of the control unit and secure
the control unit and belt around the waist. en secure the magnetic couplings on
the garment in accordance with the picture above. Ensure that they are positioned
correctly.
EN

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START
Ensure that the garment
unit is dry. Start the
control unit using the
ON/OFF button.
Press “PLAY/PAUSE”
once.
e display shows:
e gures on the display
show the remaining time
in minutes.
IF NECESSARY:
PAUSE by pressing
“PLAY/PAUSE” once.
e display then shows:
Press PLAY/PAUSE again
to continue.
FINISH
Turn o the control
unit using the ON/
OFF button. Remove
the control unit before
taking o the jacket
and trousers. Clean and
store EXOPULSE Mollii
Suit according to the
instructions.
DURING USE
Take the opportunity
to move about while
using the equipment and
practise the movements
that are hard to
implement.
BEAR IN MIND
EXOPULSE Mollii Suit
is intended to be used
for approx. 60 minutes
every other day. Always
follow EXONEURAL
NETWORK's
instructions for safe use.
EN

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About electrical nerve and muscle
stimulation
EXOPULSE Mollii Suit generates pulses with the following parameters (applies at 1,000
Ω):
• Pulse width: variable between 25 and 170 µs
• Length of period: 50 ms
• Maximum amplitude: 20 V
Each EXOPULSE Mollii Suit suit is customised when it is prescribed. Depending on
diagnosis and manual examination of the patient, the prescriber decides which muscles
are to be stimulated and with which pulse width. e user is not able to set pulse pa-
rameters or which muscles are to be stimulated.
On every start and continuation from pause mode, the pulse width is increased by up
to 5 µs every 5 seconds from 25 µs until the preset pulse width is reached.
Time
Period length
Pulse width
Amplitude
High pulse Low pulse High pulse
EN

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Table Data and Standards
EXOPULSE Mollii Suit is CE-labelled as a medical device, and thereby complies with the
directive concerning medical devices (MDD 93/42/EEC) and the EMC directive.
In order to meet the requirements, EXONEURAL NETWORK has voluntarily chosen
to full
• EN ISO 14971 Application of risk management to medical devices
• IEC 60601-1, Safety of electrical medical devices
• EN ISO 10993 Biocompatibility
• EN ISO 13485 Quality management for medical device businesses
e tables below contain information from the EMC tests that EXOPULSE Mollii Suit
has undergone. Please read the guidance therein regarding the environment and distance
to other electronic equipment.
Guidance and the manufacturer’s declaration – electromagnetic radiation
EXOPULSE Mollii Suit is intended to be used in an electromagnetic environment as
below. It is the customer’s and the user’s responsibility to ensure that usage is limited
to the environment described.
Emissions test Conformity Electromagnetic environment
– guidance
RF-emissions
CISPR 11
Group 1 EXOPULSE Mollii Suit only
uses radio frequency energy
for internal functions. e
amount of radio frequency
radiation is therefore very
low, and the likelihood of
disrupting nearby equipment
is low.
RF-emissions
CISPR 11
Class B EXOPULSE Mollii Suit is
adapted for use in domestic
environments and other
environments connected to
the generally available mains
supply.
Harmonious emissions
IEC 61000-3-2
N/A
Voltage variations (icker
emissions)
IEC 6100-3-3
N/A
EN

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Guidance and the manufacturer’s certication – electromagnetic immunity
EXOPULSE Mollii Suit is intended to be used in an electromagnetic environment as below. It is the
customer’s and the user’s responsibility to ensure that usage is limited to the environment described.
Immunity test IEC 60601 test level Conformity Electromagnetic envi-
ronment – Guidance
Electrostatic dis-
charge (ESD)
IEC 61000-4-2
+/- 6 kV contact
+/- 8 kV air
+/- 6 kV contact
+/- 8 kV air
Floors should be made
of wood, concrete or
ceramic tiles. If oors
are covered by synthetic
material the relative
atmospheric humidity
should be at least 30 %
Electrical fast
transient / Burst
IEC 61000-4-4
+/- 2 kV for power
supply lines
+/- 1 kV for input/
output lines
N/A
Not relevant in this
case, EXOPULSE
Mollii Suit is oper-
ated by an internal
voltage source (bat-
teries).
-
Overvoltage
protection
IEC 61000-4-5
+/- 1 kV dierential
mode
+/- 2 kV common
mode
N/A
Not relevant in this
case, EXOPULSE
Mollii Suit is oper-
ated by an internal
voltage source (bat-
teries).
-
Voltage dips,
failures and
variations in
current and voltage
supply
IEC 61000-4-11
<5 % UT
(>95 % dip in UT)
for 0.5 cycles
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec
N/A
Not relevant in this
case, EXOPULSE
Mollii Suit is oper-
ated by an internal
voltage source (bat-
teries).
-
EN
Power frequency
(50/60 Hz) Magnet-
ic eld
IEC 61000-4-8
3 A/m 3 A/m e magnetic eld’s
mains frequency must
be at levels that are
typical for domestic or
hospital environments.
NOTE UT is the value of the AC voltage source before testing.

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Guidance and the manufacturer’s certication – electromagnetic immunity
EXOPULSE Mollii Suit is intended to be used in an electromagnetic environment as below. It is the cus-
tomer’s and the user’s responsibility to ensure that usage is limited to the environment described.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80MHz to 2,5GHz
10Vrms
10 V/m
Portable- and mobile RF communication
equipment with accompanying leads
should be kept at the recommended
distance from EXOPULSE Mollii Suit.
e distance can be calculated using the
equation below and the frequency of
radiation from the radiation source.
Recommended distance:
150 kHz - 80 MHz:
Pd 2,1=
80 MHz - 2.5 GHz:
Pd 3,2
=
Where P is the maximum outgoing
output of the transmitter in watts (W)
from the manufacturer of the equipment
and d is the recommended distance in
metres (m).
e eld strength from xed radio fre-
quency radioactive sources is determined
by an electromagnetic site investigation
a), but should be lower than the level for
the respective frequency interval b).
Interference can arise in the vicinity
of equipment marked with the symbol
below:
NOTE 1 e higher frequency interval applies at 80MHz and 800MHz.
NOTE 2 is guidance does not apply in all situations and environments. e electromagnetic environ-
ment can be aected by absorption and reection from objects, people and other environmental factors.
a) Field strengths from xed transmitters, such as base stations for radio (mobile or wireless) telephones,
mobile radio, amateur radio, AM and FM transmissions and TV broadcasts cannot be predicted with
theoretical accuracy. A site investigation should be considered to evaluate the electromagnetic environ-
ment on the basis of these factors. If the eld strength measured in locations where EXOPULSE Mollii
Suit EXOPULSE Mollii Suit is going to be used exceeds the above RF values, use of EXOPULSE Mollii
Suit EXOPULSE Mollii Suit should be monitored and regulated so that normal function can be ensured. If
variations in functionality are observed, further measurements, as well as moving and testing EXOPULSE
Mollii Suit EXOPULSE Mollii Suit in other environments, should be implemented.
b) e eld strength for the 150 kHz -80MHz frequency interval must be less than 10 V/m.
Recommended distance between portable and mobile RF communication equipment and EXOPULSE
Mollii Suit
EN

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Recommended distance between portable and mobile RF communication equipment
and EXOPULSE Mollii Suit
EXOPULSE Mollii Suit is intended for use in an electromagnetic environment where dis-
turbances and radiation from RF equipment can be checked. e customer and user of
EXOPULSE Mollii Suit can prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communication equipment (transmitter) and EX-
OPULSE Mollii Suit according to the recommendations below. e distance depends on the
maximum voltage of the RF communication equipment.
Maximum output
voltage of the trans-
mitter
W
e distance depends on the frequency of the transmitter (m)
150 kHz to 80 MHz
Pd 2,1=
80 MHz to 800 MHz
Pd 2,1=
800 MHz to 2.5 GHz
Pd 3,2
=
0.01 0.12 0.12 0.24
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters with an output voltage that is not listed in the table above, the distance can
be calculated using the equation in the table above. Where P is the maximum output power in
watts (W) indicated by the manufacturer and d is the distance in metres (m)
NOTE 1 e higher frequency interval applies at 80MHz and 800MHz.
NOTE 2 is guidance does not apply in all situations and environments. e electromagnet-
ic environment can be aected by absorption and reection from objects, people and other
environmental factors.
EN

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Reporting faults and accidents
Contact EXONEURAL NETWORK AB immediately in the event of accidents or
incidents. Use the contact details below:
EXONEURAL NETWORK
Svärdvägen 11D
182 33 Danderyd
Sweden
Tel: [phone]
Mail: suppo[email protected]m
If equipment is defective, contact EXONEURAL NETWORK using the contact details
above for return instructions.
EN