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Fesia F0X6-XM, Instructions For Use Manual

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SYMBOLS

Symbols

Meaning 

Caution

Complies with European regulatory requirements for medical devices

Manufacturer

Device reference number

Serial number

FW-YYWWxx 

                

 

YYWW:   

YY(year)WW(week) of manufacturing

 

xx: 

 

Correlative number of same lot

Consult the instructions

Double insulation (equivalent to Class II according to IEC 536)

Type BF applied parts

Continuous load current

Non-ionizing radiation

Keep out of sunlight

Keep dry

This product should not be disposed with other household products

Indicates low battery (red light)

Indicates that the stimulation is active (yellow light)

Indicates the intensity increase button

Indicates the intensity reduction button

Indicates the button on/off system

LEGEND

This user guide includes additional audio-visual material to encourage inclusive and accessible learning for every person. 

Find the legend of the symbology you will found along this document.

0051

Símbolo

Significado

This section includes a video.

GENERAL INFORMATION 

01

01

 GENERAL INFORMATION

INSTRUCTIONS FOR USE | 

Fesia

 Walk   11

10  INSTRUCTIONS FOR USE | 

Fesia

 Walk

Summary of Contents for F0X6-XM

Page 1: ...INSTRUCTIONS FOR USE FESIA WALK FESIA FW01 IFU EN 2021 11...

Page 2: ...ANUFACTURER Fesia Technology S L P Mikeletegi 58 20009 Donostia San Sebasti n Spain COMERCIALIZED BY Fesia Technology S L P Mikeletegi 58 20009 Donostia San Sebasti n Spain E MAIL support fesia net WE...

Page 3: ...ment Removal of the Device Fesia Pro Application 21 29 General Description Installation and Registration Main Menu Habituation Protocol Gait Protocol Technical Support 30 31 Troubleshooting Contact wi...

Page 4: ...GENERAL INFORMATION 01...

Page 5: ...poor condition Should not be exposed to liquids or splashes Should not be exposed to extreme temperatures Should not be exposed to direct sunlight Should not be used near flammable products Store the...

Page 6: ...uct should not be disposed with other household products Indicates low battery red light Indicates that the stimulation is active yellow light Indicates the intensity increase button Indicates the int...

Page 7: ...02 FESIA WALK DEVICE...

Page 8: ...vements During gait the sensor is able to detect the takeoff and foot contact times in order to trigger the stimulation with the corresponding parameters 5 Fesia Pro app already installed in pre confi...

Page 9: ...cator Bluetooth indicator Ba ery indicator Bluetooth indicator Ba ery indicator S mulator connected to Fesia Pro App S mulator O Appropriate ba ery level Low ba ery SENSOR INDICATOR STATUS STIMULATOR...

Page 10: ...DEVICE 02 02 FESIA WALK DEVICE INSTRUCTIONS FOR USE Fesia Walk 19 18 INSTRUCTIONS FOR USE Fesia Walk INITIAL CHECKS FULLY CHARGED Before the first use the batteries must be ful ly charged The charging...

Page 11: ...tella Insert the stimulator into the base of the electrode Tighten until it clicks and make sure it is properly inserted R R Close the garment using the magnetic fas tener and adjust it to suit DEVICE...

Page 12: ...fore placing the protec tive layers on it If the electrode gel is humid carefully dry with a cotton thread gauze Finally place the protective plastics back on the electrode gel Make sure that the plas...

Page 13: ...FESIA PRO APPLICATION 03...

Page 14: ...red data click on the Save button It is important to ensure not to use the application more than 50 meters away from the stimulator in open free space to avoid losing the connection Search for the app...

Page 15: ...uetooth connection with the device this option is available from any of the windows in the app Access the application Settings Create a new patient See the list of patients and access their profile an...

Page 16: ...tocols Habituation Tone Reduction Gait PATIENT S MENU The patient s data will be shown in the Detail menu The mandatory fields are indicated with an asterisk Walk Sessions Detail Walk Detail Sessions...

Page 17: ...r the corresponding images of the affected limb Non activated cathode Activated cathode Blocked cathode CLICK CLICK LONG TOUCH By doing a long touch on the cathodes it is possible to stimulate in real...

Page 18: ...y Once the session is finished click on the red Stop button When going back in the navigation bar a mes sage will appear in which you must choose be tween Save session or Exit without saving Select co...

Page 19: ...tensity edition Select the desired configuration and stimulation time Edit the intensity by increasing the value progres sively Stimulation parameters can be edited frequency pulse width by clicking o...

Page 20: ...RATION Last session It loads all the configuration of the last session Habituation It loads the intensity value set as motor threshold and frequency and pulse width defined in the Habituation protocol...

Page 21: ...s sion can be started stopped when desired Edit the relative intensity if desired Play Press Play to start the sti mulation 2 1 Edit intensity Remember that the relative intensity is being increased o...

Page 22: ...TECHNICAL SUPPORT 04...

Page 23: ...the device again Create a new a new patient and follow the steps again Make sure you have checked the following steps before contacting Fesia 1 2 SUBJECT Device ID Short explanation of issue MESSAGE D...

Page 24: ...05 TECHNICAL INFORMATION...

Page 25: ...S DESCRIPTION Pulse Type Symmetrical biphasic or compensated biphasic Pulse Intensity 0 60mA 1mA resolution for loads 5000 Pulse Width 150us 300 us resolution of 10us Pulse Frequency 1 40Hz resolution...

Page 26: ...ting temperature 5 C to 40 C Transport and storage temperature 0 to 40 Optimum temperature for long term storage 5 C to 27 C Recommended storage time 3 months sealed Expiration time 3 years sealed Rel...

Page 27: ...k device is suitable for use in esta blishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Immun...

Page 28: ...viles The Fesia Walk device is intended for use in a electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the Fesia Walk device can help prevent electr...

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