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Mollii Control unit, User Manual

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Mollii Control unit User Manual Download Page 22

19

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 fulfil 

 

 

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  

6. Table Data and Standars

 

Summary of Contents for Control unit

Page 1: ...s and applies to Mollii The operating instructions are valid from xx xx 2019 Firmware version 1 3x Inerventions AB Sv rdv gen 11D SE 182 33 Danderyd Tel 46 0 8 410 277 01 WARNING Read and understand o...

Page 2: ......

Page 3: ...omplete 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...

Page 4: ...1 1 EIGHT STEP INSTRUCTION ON HOW TO USE MOLLII...

Page 5: ...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 WARNINGS Do not modify Mollii without authorization of the man...

Page 6: ...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 su...

Page 7: ...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 Reg...

Page 8: ...control unit sup plied with a belt Note Jacket trousersandcontrolunithaveuniqueitemnumbers Mollii trousers Mollii jacket Laundry bag x2 CHECK THAT THE SET IS COMPLETE Protective box for the control un...

Page 9: ...g 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 OPEN BATTERY COVER Pla...

Page 10: ...crewdriver CHECK THE BATTERY LEVEL Turn the control unit on by pressing the ON button Check the battery level Battery full Battery low Replace batteries Battery half full DRESSING UP FAVOR NARROW UNDE...

Page 11: ...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 WIT...

Page 12: ...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 fo...

Page 13: ...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 slid...

Page 14: ...onnector 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 le...

Page 15: ...12 Incorrect positions Correct position...

Page 16: ...g 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 END THE MOLLII SESSION TURN...

Page 17: ...indoors under the following conditions 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 d...

Page 18: ...as ing sensation during use Incorrect position of mag netic arms on the connec tors OR Electrodes are not in good contact with the skin Verify battery level and check installation of control unit and...

Page 19: ...accidents If an accident injury or incident occurs please contact Inerventions AB Faulty equipment must not be used Immediately contact Inerventions AB Sv rdv gen 11D 182 33 Danderyd Tel 46 0 8 410 27...

Page 20: ...ed 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 param eter setti...

Page 21: ...e 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 staff pre programs which muscles nerves to be stimulated based...

Page 22: ...971 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 I...

Page 23: ...20...

Page 24: ...USE mode Symbol Dry flat Display Product defect do not use the product Contact Inerventions AB if this symbol is displayed Symbol Do not dry clean Display Battery indicator Battery full Symbol Do not...

Page 25: ...art number Fragile European Community Repre sentative Keep dry Serial Number Manufacturer Degree of ingress protection per IEC 60529 Altitude pressure range Temperature range Do not use device if pack...

Page 26: ...Inerventions AB Sv rdv gen 11D SE 182 33 Danderyd Tel 46 0 8 410 277 01...

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