Inerventions Mollii User manual

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

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 is user manual (version 1.55.2 EN) was produced by Inerventions and applies to Mollii.
 e operating instructions are valid from 2017-05-01.
So ware version: 1.2x
Inerventions AB, Svärdvägen 11D, SE-182 33 Danderyd. Tel: [phone]
User Manual (EN) .................................................................................... 5

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ENGLISH

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Intended use
Mollii is a personal assistive device. Electrically stimulating the muscles relaxes spastic,
tense and aching muscles and activates weak musculature.
Mollii is for use in the home environment.
Change of name
Mollii was previously called Elektrodress 100.
Mollii consists of
Mollii - Garment unit (item number: 100-1)
1 jacket and 1 pair of trousers supplied with laundry
bags.
Mollii - 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.inerventions.se
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Button: ON/OFF.
Turns the control unit on and off
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 Inerventions 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 Mollii. Symbol: Do not wring out when drying.
Symbols
0413
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CONTRA-
INDICATIONS
Never use Mollii:
- 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 Mollii
disturbing the function
of the above-mentioned
types of equipment.
All incorrect usage is at
the user's own risk.
CAUTION
Do not use Mollii with-
out 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.
Mollii 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.
Mollii 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 Mollii
can cause discomfort.
 e garment should
consequently be turned
off if it gets wet, and
drinks and liquids should
be avoided during use.
Jewellery/accessories
should not be used
together with Mollii.
Safety instructions
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SAFE USE
- Never insert objects or
tools under the garment.
- Do not use Mollii if the
control unit has visible
marks or is damaged.
- Do not use Mollii in wet
rooms, direct sunlight
or in connection with
 ammable materials/
liquids.
- Do not use Mollii 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.
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 Mollii if there
are sores on the skin or if
it is irritated or injured.
- follow the instructions
for cleaning.
BEAR IN MIND
Mollii is intended to
be used for approx.
60minutes every other
day.
Take care when using
Mollii. Bear in mind that,
for example, the balance
can be aff ected.
Do not undertake
demanding or heavy
physical exercise when
using Mollii.
Mollii must not be used
outdoors. Tip: use Mollii
prior to outdoor activity
- the eff ect lasts for up to
72 hours.
CONTACT
INERVENTIONS
- 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:
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ENVIRONMENT
Mollii 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 Mollii
clean and dry.
BEAR IN MIND
 e  ooring material can
aff 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 Mollii
to Inerventions AB
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 Mollii
before it is used for the
 rst time. Always check
that Mollii is intact, dry
and clean before use.
AFTER USE
Rinse the whole garment
with cold water or wipe
off 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 off with a lightly
dampened cloth with no
detergent.
A poorly cleaned
garment or dirty skin
can result in eczema or
a rash.
DURABILITY
Mollii should last for
25 washes, or 2 years of
regular use. Use over and
above this is not covered
by the warranties of
Inerventions.
STORAGE
Keep Mollii dry and at
room temperature. Avoid
dusty, damp and bright
environments.
Store and transport
Mollii in its original
packaging.
Remove all batteries if
Mollii 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 Inerventions AB.
Faulty equipment must
not be used. Contact
Inerventions AB for
service and support.
Environment, Storage, Usage
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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.
Mollii has been tested
with rechargeable
batteries from GP (item
number: 100AAAHC).
DRESSING
Always check that Mollii 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 magnetic
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:
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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.
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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.
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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 off the control
unit using the ON/
OFF button. Remove
the control unit before
taking off the jacket and
trousers. Clean and store
Mollii 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
Mollii is intended to
be used for approx.
60 minutes every
other day. Always
follow Inerventions'
instructions for safe use.
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About electrical nerve and muscle
stimulation
Mollii 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 Mollii 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 parameters 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
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Table Data and Standards
Mollii 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, Inerventions 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 Mollii has undergone.
Please read the guidance therein regarding the environment and distance to other
electronic equipment.
Guidance and the manufacturer’s declaration – electromagnetic radiation
Mollii 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 environ-
ment described.
Emissions test Conformity Electromagnetic environment
– guidance
RF-emissions
CISPR 11 Group 1 Mollii only uses radio fre- quency 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 Mollii is adapted for use in domestic environments and
other environments connect-
ed to the generally available
mains supply.
Harmonious emissions
IEC 61000-3-2 N/A
Voltage variations ( icker
emissions)
IEC 6100-3-3
N/A
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Guidance and the manufacturer’s certi cation – electromagnetic immunity
Mollii 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, Mollii is oper-
ated by an internal
voltage source (bat-
teries).
-
Overvoltage
protection
IEC 61000-4-5
+/- 1 kV diff erential
mode
+/- 2 kV common
mode
N/A
Not relevant in this
case, Mollii 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, Mollii is oper-
ated by an internal
voltage source (bat-
teries).
-
Power frequency
(50/60 Hz) Mag-
netic  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
Mollii 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 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 Mollii.
 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 aff 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 Mollii is going to be
used exceeds the above RF values, use of Mollii should be monitored and regulated so that normal func-
tion can be ensured. If variations in functionality are observed, further measurements, as well as moving
and testing Mollii 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 Mollii
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Recommended distance between portable and mobile RF communication equipment
and Mollii
Mollii is intended for use in an electromagnetic environment where disturbances and radia-
tion from RF equipment can be checked.  e customer and user of Mollii can prevent electro-
magnetic interference by maintaining a minimum distance between portable and mobile RF
communication equipment (transmitter) and Mollii 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 electromag-
netic environment can be aff ected by absorption and re ection from objects, people and other
environmental factors.
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Reporting faults and accidents
Contact Inerventions AB immediately in the event of accidents or incidents. Use the
contact details below:
Inerventions AB
Svärdvägen 11D
182 33 Danderyd
Tel: [phone]
Mail: [e-mail]
If equipment is defective, contact Inerventions using the contact details above for return
instructions.
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