EXOPULSE Mollii Suit User Manual
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EXOPULSE Mollii Suit User Manual

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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: +46 (0)8 410 277 01

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Summary of Contents for EXOPULSE Mollii Suit

  • Page 1 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...

  • Page 2: Table Of Contents

    EXOPULSE Mollii Suit User Manual rev. 5.00 TABLE OF CONTENT 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 ..........

  • Page 3: How To Use The Exopulse Mollii Suit In Eight Steps

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

  • Page 4: Step

    STEP 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.
  • Page 5 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: •...
  • Page 6 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.
  • Page 7 EXOPULSE Mollii Suit User Manual rev. 5.00 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.
  • Page 8 • 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: •...

  • Page 9: Step 2 Check That The Set Is Complete

    EXOPULSE Mollii Suit User Manual rev. 5.00 STEP 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.

  • Page 10: Step 3 Insert Batteries

    EXOPULSE Mollii Suit User Manual rev. 5.00 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.

  • Page 11: Step 4 Dressing Up

    EXOPULSE Mollii Suit User Manual rev. 5.00 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.
  • Page 12 EXOPULSE Mollii Suit User Manual rev. 5.00 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...
  • Page 13 EXOPULSE Mollii Suit User Manual rev. 5.00 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...

  • Page 14: Step 5 Attach The Control Unit

    EXOPULSE Mollii Suit User Manual rev. 5.00 STEP 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:...
  • Page 15 EXOPULSE Mollii Suit User Manual rev. 5.00 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.
  • Page 16 EXOPULSE Mollii Suit User Manual rev. 5.00 Correct position: Incorrect positions:...

  • Page 17: Step 6 Start A 60-Minute Exopulse Mollii Suit Session

    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.

  • Page 18: Step 8 Cleaning And Storage

    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...

  • Page 19: Troubleshooting Section

    EXOPULSE Mollii Suit User Manual rev. 5.00 2. TROUBLESHOOTING SECTION Problem Possible causes Solution No display Replace batteries batteries Batteries inserted Check instructions in incorrectly Section 1 STEP 3 Display The control unit is Contact EXONEURAL NET- showing the unprogrammed...

  • Page 20: Reporting Faults And Incidents

    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...

  • Page 21: Electrical Nerve And Muscle Stimulation

    • Maximum amplitude: 20 V Each EXOPULSE 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.

  • Page 22: Technical Description

    The EXOPULSE Body Garments are type BF applied part. The EXOPULSE Mollii Control Unit is an accessible part. SHELF LIFE The shelf life of the EXOPULSE body garment is 2 years and the shelf life of the EXOPULSE Mollii Control Unit is 3 years. MATERIALS...
  • Page 23 EXOPULSE Mollii Suit User Manual rev. 5.00 ENERGY CONSUMPTION The EXOPULSE Mollii Suit Control Unit is powered by 4 x AAA batteries. Use alkaline batteries only. Alkaline batteries allow to provide several treatments before they are depleted. For safe disposal of the depleted batteries, please follow the instructions on the battery packaging and local regulations (including WEEE Directive 2012/19/EU).
  • Page 24 EXOPULSE Mollii Control Unit is CE-labelled, and thereby compliant to Regulation (EU) 2017/745 (MDR). EXOPULSE Body Garments are CE-labelled, and thereby compliant to Regulation (EU) 2017/745 (MDR). In order to meet the requirements, the EXOPULSE Mollii Suit fulfils the requirements of International Standards: EN ISO 14971 IEC 60601-1...
  • Page 25 EXOPULSE Mollii Suit User Manual rev. 5.00 Emissions test IEC 60601-1-2 test level Conformity Group 1, Class B Group 1, Class B RF-emissions CISPR 11 Immunity test IEC 60601-1-2 test level Conformity +/- 8 kV contact +/- 8 kV contact...

  • Page 26: Symbols

    EXOPULSE Mollii Suit User Manual rev. 5.00 7. SYMBOLS EXOPULSE Mollii Control Unit: Button: ON/OFF. declaration of conformity according to Turns the control unit on and off the Regulation (EU) 2017/745. 2862 respectively is the identification number for the notified body.
  • Page 27 EXOPULSE Mollii Suit User Manual rev. 5.00 Temperature range Catalog/re-order part number Fragile Date of manufacture YYYY-MM-DD Keep dry Serial number Manufacturer Ingress Protection Drip-proof Unique Device Identifier Altitude/pressure range Relative humidity range Do not use device if packing is...
  • Page 28 EXOPULSE Mollii Suit User Manual rev. 5.00 EXONEURAL NETWORK AB Barks väg 7, 170 73 Solna SWEDEN Phone: +46 (0)8 410 277 01 www.exopulse.com...

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