Mollii Jacket, Trousers, Control unit User Manual

User Manual

ENGLISH

WARNING

!

Read and understand

operator’s manual

and all other safety

instructions before using

this equipment.

This user manual (version 1.6 EN) was produced by Inerventions and

applies to Mollii. The operating instructions are valid from xx-xx-2019.

Firmware version: 1.3x

Inerventions AB, Svärdvägen 11D, SE-182 33 Danderyd

Tel: [phone]

TABLE OF CONTENT

1. Eight step instruction on how to use Mollii

STEP 1: Read the intended use and safety instructions carefully

STEP 2: Check that the set is complete
STEP 3: Insert batteries
STEP 4: Dressing up
STEP 5: Install the control unit
STEP 6: Start a 60-minute Mollii session
STEP 7: End the Mollii session
STEP 8: Cleaning Mollii, storage and service life

2. Trouble shooting

3. Reporting faults and accidents

4. About electrical nerve and muscle stimulation

5. Technical description

6. Data and standards

7. Symbols

1. EIGHT-STEP INSTRUCTION ON
HOW TO USE MOLLII

1

STEP

INDICATIONS FOR USE

Mollii is intended for management and symptomatic relief of chronic intractable,
post-traumatic and post-surgical pain, as a transcutaneous electrical nerve stimula­tion (TENS) device; and for muscle re-education, prevention or retardation of disuse
atrophy, increasing local blood circulation, maintaining or increasing range of mo­tion, and relaxation of muscle spasms and as a neuromuscular electrical stimulation
as a neuromuscular electrical stimulation (NMES) device.

CONTRA INDICATIONS

Do not use:

There 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.

READ THE INTENDED USE AND SAFETY INSTRUCTIONS
CAREFULLY

1

- 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.

WARNINGS

Do not modify Mollii without authorization of the manufacturer.

Use of this equipment adjacent to or stacked with 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 specied or provided
by the manufacturer of Mollii could result in increased electromagnetic emissions
or decreased electromagnetic immunity of this equipment and result in improper
operation.

Do not use Mollii near a magnetic resonance imager.

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

2

cables specied by the manufacturer. Therapeutic equipment that transmits micro-

waves or short waves should be used no closer than 1 m (33 inches) to any part of
the equipment. Otherwise, this could result in the degradation of the performance

of the equipment.

CAUTIONS

Do not use Mollii without consulting a doctor in connection with:

- Cardiovascular diseases or other types of related conditions.

- Malignancy (cancer)

- Infectious diseases

- Fever

- Pregnancy

- Bone fracture

- Skin disease, rashes or other skin problems

- Usage together with another medical device, such as cochlear implants.

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.

Mollii may only be used by, or under the supervision of, a person who has read and
understood the entire user manual.

Children under the age of 18, may only use Mollii under parental/caregiver
supervision.

Take care when children and pets are present.

Spilling liquid on Mollii 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 immediatly be turned o in such circumstances.

Do not use Mollii outdoors, in wet rooms, in direct sunlight or in connection with
ammable materials/liquids. Keep the surrounding environment of Mollii clean and
dry.

Ensure that the magnetic coupling (in garment and control unit) does not come
into contact with devices that can be destroyed by magnets.

Ensure that the magnetic couplings are correctly positioned, instructions can be
found in STEP 5.

Jewellery/accessories (in contact with the garment) should not be used together

3

with Mollii.

Never insert objects or tools under the garment.

Do not use Mollii if the control unit has visible marks or is damaged. Always check
that Mollii is intact, dry and clean before use, and make sure to wash the garment

before using it the rst time.

Wearing Mollii can cause sweating and dehydration, especially when worn in
humid and warm conditions. Drink sucient uids in order to avoid dehydration.

Take care when using Mollii. Bear in mind that, for example, balance may be
aected. Do not undertake demanding or heavy physical exercise when using
Mollii

Mollii is intended to be used for 60 minutes every other day. The eect may last for
up to 48 hours.

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 moisturise the skin frequently with unscented skin lotion. Avoid using
Mollii when your skin is dry.

- To never use Mollii if there are sores on the skin or if it is irritated or injured.

ACCIDENTS, INJURIES OR INCIDENTS

Immediately contact Inerventions AB if an accident, injury or incident occurs, or if
this symbol shows up on the screen:

Contact:
Inerventions AB
Svärdvägen 11D
182 33 Danderyd
Tel: [phone]
Mail: [e-mail]

4

STEP

CHECK THAT THE SET IS COMPLETE

2

Mollii jacket*

Mollii control unit sup­plied with a belt*

Mollii trousers*

Laundry bag x2

Protective box for the
control unit

* Note: Jacket, trousers and control unit have unique item numbers.

5

STEP

3

It is best to use rechargeable NiMH batteries. Alkaline AAA batteries are acceptable
for use.

Do not use carbon-zinc AAA batteries as they do not last very long and they may
leak acid into the Mollii device.

OPEN BATTERY COVER

Place the control unit with the screen facing down. Pull the belt away to uncover
the battery hatch. Use a crosshead screwdriver to undo the 4 screws on the rear of
the control unit and remove the rear cover.

INSERT BATTERIES

INSERT BATTERIES

Insert 4 x AAA batteries according to the 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

6

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
rmly using a screwdriver.

CHECK THE BATTERY LEVEL

Turn the control unit on by pressing the ON button. Check the battery level:

Battery full Battery low.

STEP

4

FAVOR NARROW UNDERWEAR

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.

DRESSING UP

Battery half full

Replace batteries

7

OPEN ALL THE TROUSERS’ ZIPPERS BEFORE DRESSING UP

PUT THE TROUSERS ON

ADJUST THE KNEE-CAP PLACEMENT

Ensure that the seam is above the knee.

CLOSE THE TROUSERS’ ZIPPERS

CHECK THAT THE ELECTRODES ARE IN CONTACT WITH THE SKIN

8

OPEN ALL THE JACKET’S ZIPPERS

PUT THE JACKET ON

ENSURE THE JACKET IS OVER THE PANTS

The jacket should be outside the trousers. Snap the jacket to the trousers 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
straigh line between the elbow and the little nger as indicated below:

9

STEP

INSTALL THE CONTROL UNIT

5

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

10

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 nally
the lower right magnetic arm on the lower right connector.

Make sure each magnetic arm is correct positioned on each connector, as indicated
below.

11

Correct position:

Incorrect positions:

12

STEP

START A 60-MINUTE 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 Mollii, you can remain still, move around or exercise. Check that each
magnetic arm is in the correct postion, when moving around. If not, make sure to
reposition it correctly.

START A 60-MINUTE MOLLII SESSION

6

STEP

END THE MOLLII SESSION

7

TURN OFF THE CONTROL UNIT AND REMOVE IT

Turn o 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

13

STEP

REGULARLY CLEANING

Rinse the whole garment with cold water or, wipe o the electrodes using baby
wipes. Clean the control unit, magnetic arms and connectors using a lightly
dampened cloth with no detergent. Do not immerse the control unit in water.

MACHINE WASH INSTRUCTIONS

The garment can be machine washed at 40°C/104°F, using delicate wash. Wash
regularly (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 spearately in the two laundry bags supplied.

STEAM CABINET INSTRUCTIONS

The garment can be steamed washed. We recommend to use LG Essence Style
S3WF. Please note that steam washing does not remove stains.

OPERATING AND STORING

Mollii should be operated and stored indoors under the following conditions:

CLEANING MOLLII, STORAGE AND SERVICE LIFE

8

- Temperature 0-50°C.

- Atmospheric humidity: Relative humidity 5% to 90%.

- Atmospheric pressure: circa 1,060 hPa to 700 hPa (-384 m to 3,000 m above sea
level).

- Avoid dusty, damp and bright environments.

- Store Mollii control unit in the protective box.

- Remove all batteries if Mollii is not going to be used for 3 weeks or more.

SERVICE LIFE

Mollii is garanteed to last for 25 machine washes, or 250 steam cabinet washing,
or 2 years of regular use under the condition prescribed herein. Use over and
above this service life, or outside the prescribed conditions, is not covered by the
warranties of Inerventions AB.

DISPOSAL

Please return Mollii to Inerventions AB for disposal. Please handle used batteries in
accordance with the WEEE directive.

TRANSPORT

Temperature: -25 to 70°C
Atmospheric humidity: Relative humidity 5% to 90%
Atmospheric pressure: circa 1,013 hPa to 19hPa (0 m to 12,000 m above sea level)

14

2. Trouble Shooting Section

Problem Possible causes Solution

No display Low batteries

OR
Batteries inserted incor­rectly

Display showing
the symbol

Sudden change in
sensation
OR
Shifting/decreas­ing sensation
during use

The skin turns red
or the skin feels
irritated

The control unit is unpro­grammed

Incorrect position of mag­netic arms on the connec­tors
OR
Electrodes are not in good
contact with the skin

Dry skin or electrodes are
not in good contact with
the skin

Replace batteries
OR
Check instructions in Section
1 STEP 3

Contact Inerventions AB or
your local reseller

Verify battery level and check
installation of control unit
and adjust suit according to
instructions in Section 1 STEP
4 and STEP 5.

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.

15

3. Reporting faults and accidents

If an accident, injury or incident occurs, please contact Inerventions AB. Faulty

equipment must not be used.

Immediately contact:

Inerventions AB
Svärdvägen 11D
182 33 Danderyd
Tel: [phone]
Mail: [e-mail]

16

4. About electrical nerve and muscle
stimulation

Mollii generates 2 milliamp pulses (into 0-10,000 Ohms) with the following param­eters:

• Pulse width: variable between 25 and 170 µs

• Length of period: 50 ms

• Maximum amplitude: 20 V

Each Mollii suit is customized 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 parameter setting. The user cannot change param­eter settings and/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.

Amplitude

17

Period length

Pulse width

High pulse Low pulse High pulse

Time

5. Technical Description

Mollii is a multi-channel full-body suit with a low energy electrical stimulation – 20
Volt and 20 Hz. It is composed of a control unit, a jacket and a trouser, with 58 em­bedded electrodes, in direct contact with the skin, and pre-positioned to stimulate
40 key muscle groups. The suit comes in 25 sizes, starting from 104 cm up to XXXL
woman and man.

A trained medical sta pre-programs which muscles/nerves to be stimulated based
on a clinical assessment of the user. The stimulation program is thus specic to each
user. The operator or user can then start/pause/stop the pre-programmed session,
but cannot change which muscles/nerves should be stimulated and with which
intensity.

18

6. Table Data and Standars

Mollii is CE-labelled as a medical device, and thereby complies with the directive
concerning medical devices (MDD 93/42/EEC).

In order to meet the requirements, Inerventions has voluntarily chosen to full

EN ISO 14971 and ISO 14971 Application of risk management to medical
devices
IEC 60601-1 Safety of electrical medical devices
ISO 10993-1 Biocompatibility
ISO 10993-5 Cytotoxicity
ISO 10993-10 Sensitization and Irritation
ISO 13485 Quality management for medical device businesses
IEC 60601-1-2
IEC 60601-1-6/IEC 62366/IEC 62366-1
IEC 60601-1-11, IEC 60529 (IP22)
ANSI/AAMI NS4 3013:/(R)2017
IEC 62034
Rohs (2 and 3)
Reach
ISTA 2A / 3A

19

20

7. Symbols

Button: ON/OFF.
Turns the control unit on and o
respectively

Button: PLAY/PAUSE

Display: If this symbol is visible in
the display, the control unit is in
PLAY mode

Display: If this symbol is visible in
the display, the control unit is in
PAUSE mode

Display: Product defect – do not
use the product!
Contact Inerventions AB if this
symbol is displayed

Display: Battery indicator
Battery full

Display: Battery indicator
Battery low. Replace batteries

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: Patient connection is
classied: BF

0413

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.

Symbol: Date of manufacture
YYYY-MM-DD

Symbol: Machine wash 40° C,
delicate wash. Do not use fabric
soener

Symbol: Dry at

Symbol: Do not dry-clean

Symbol: Do not tumble-dry

Symbol: Do not iron

Symbol: Do not bleach

Symbol: Do not wring out when
drying

21

Symbol: Read the entire user
manual prior to using Mollii

Temperature range

Quantity

7. Symbols

. Device is only for use by
prescription

Fragile

Keep dry Serial Number

Manufacturer Degree of ingress protection

Universal Device Identication
(UDI)

.

Temperature range .Do not use device if packing

Catalog/re-order part number

European Community Repre­sentative

per IEC 60529

Altitude/pressure range

is damaged.

22

Inerventions AB, Svärdvägen 11D, SE-182 33 Danderyd.

Tel: [phone]