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GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY

The device is intended for use in the electromagnetic environment specified below. The customer or user of this device should assure 

that it is used in such an environment.

Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment 

 

guidance

Electrostatic Discharge (ESD) 

 

IEC 61000-4-2

±6 kV contact

±8 kV air

±6 kV contact

±8 kV air

Floors  should  be  Wood,  concrete  or 

ceramic tile. If floors are covered with 

synthetic material, the relative humidi

-

ty should be at least 30%.

Electrical fast transient/bursts 

 

IEC 61000 4-4

±2 kV for Power supply 

lines

±1 kV for I/O lines 

(input/output)

±2 kV for Power supply 

lines 

±1 kV for I/O lines (input/

output)

Mains power quality should be that of 

a  typical  commercial  and/or  hospital 

environment.

Surges 

 

IEC 61000 4-5

±1 kV differential mode

±2 kV common mode

±1 kV differential mode

±2 kV common mode

Mains power quality should be that of 

a  typical  commercial  and/or  hospital 

environment.

Voltage dips, short interruptions and 

voltage variations on power supply 

input lines 

 

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

<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

Mains power quality should be that of 

a  typical  commercial  and/or  hospital 

environment. 

Frequency (50/60 Hz) magnetic field 

IEC 61000-4-8

3 A/m

3 A/m

Power  frequency  magnetic  fields 

should  be  at  levels  characteristic  of  a 

typical location in a typical commercial 

or hospital environment.

Conducted RF 

 

IEC 61000 4-6

3 vrms

150 kHz to 80 MHz

3 Vrms

d = 1,17 √P 150 kHz to 80 MHz

Radiated RF 

 

IEC 61000 4-3

3 v/m 

80 MHz to 2,5 GHz

3 V/m

d =1,17√P 80 MHz to 800 MHz

d=2,33√P 800 MHz to 2,5 GHz

Where 

P

 is the maximum output power rating of the transmitter in watts (W) according to the trans

-

mitter manufacturer and d is the recommended separation distance in meters (m). 

b

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey 

a

, should 

be less than the compliance level in each frequency range. 

b

Interference may occur in the vicinity of the equipment marked with the following symbol:  

Note 1: Ut is the AC mains voltage prior to application of the test level. 

Note 2: At 80 MHz and 800 MHz, the higher frequency range applies.

Note 3: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from 

structures, objects and people. 

a

 Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, ama

-

teur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To access the electromag

-

netic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength 

in the location in which the    device is used exceeds the applicable RF compliance level above, the device should be observed to 

verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relo

-

cation the device.

b

 Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

The device is intended for use in a electromagnetic environment in which radiated RF disturbances are controlled. The customer or 

user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile 

RF communications equipment (transmitter) and the device as recommended below, according to the maximum output power of the 

communication equipment.

RECOMMENDED SEPARATION DISTANCE BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE FESIA  

Rated maximum output power 

of transmitter [W]

150 kHz to 80 MHz

d = 1,17 √P

80 MHz to 800 MHz

d =1,17√P

800 MHz to 2,5 GHz

d=2,33√P

0,01

0,12

0,12

0,23

0,1

0,38

0,38

0,74

1

1,2

1,2

2,3

10

3,8

3,8

7,3

100

12

12

23

For transmitters rated at a maximum output power nor listed above, the recommended separation distance d in meters (m) can be 

estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the trans

-

mitter in watts (W) according to the transmitter manufacturer.

Notes:

• 

Between 80 MHz and 800 MHz, the separation distance is applied in the highest frequency range. 

• 

These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from 

structures, object and people.

GRASP DEVICE 

INSTRUCTIONS FOR USE | Fesia Grasp   65

64  INSTRUCTIONS FOR USE | Fesia Grasp

TECHNICAL INFORMATION 

06

06 

TECHNICAL INFORMATION

Содержание Grasp

Страница 1: ...INSTRUCTIONS FOR USE FESIA GRASP FESIA FG01 IFU VER5 1 EN 2022 04...

Страница 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...

Страница 3: ...RMATION 8 11 Indications of use Legend Symbols FESIA GRASP DEVICE 14 23 General description Indicators Initial checks Device placement Device removal FESIA PRO APPLICATION 26 45 General description In...

Страница 4: ...GENERAL INFORMATION 01...

Страница 5: ...Must not be used near flammable products Store the device under protection from humidity dust and direct sunlight Use only the electrodes supplied by Fesia Use only the charger and charging cable sup...

Страница 6: ...This product should not be disposed with other household products Low battery red light Stimulation is active yellow light Intensity increase button Intensity reduction button On off button LEGEND Thi...

Страница 7: ...FESIA GRASP DEVICE 02...

Страница 8: ...ted to the skin through the multi field electrode 4 Fesia Pro app already installed in pre configured tablets provided by Fesia The device has a software application that allows on the one hand to con...

Страница 9: ...ator Ba ery indicator On o bu on Bluetooth indicator Reduce intensity bu on Increase intensity bu on S mula on on S mula on o S mulator on S mulator o Adequate ba ery level Low ba ery level S mula on...

Страница 10: ...SIA GRASP DEVICE 02 02 FESIA GRASP DEVICE INSTRUCTIONS FOR USE Fesia Grasp 19 18 INSTRUCTIONS FOR USE Fesia Grasp INITIAL CHECKS FULLY CHARGED Before the first use the device must be fully charged Thi...

Страница 11: ...until it clicks and make sure it is properly inserted Make sure the hand remains completely free 5 6 R R Place the electrode and garment on the forearm The ulnar diaphysis should be aligned with the...

Страница 12: ...provided respecting environmental conditions described in chapter 5 6 At the end of life of this device follow local regulations and never dis pose the product or batteries with normal household waste...

Страница 13: ...FESIA PRO APP 03...

Страница 14: ...that the later ality has been selected correctly After filling in the required data click on the Save button Search for the application in the Google Play Store by typing Fesia Pro in the search field...

Страница 15: ...ails The mandatory fields are indicated with an asterisk Make sure the chosen laterality is co rrect The affected limb must be cho sen that is the side where the device is going to be placed See patie...

Страница 16: ...nd the evolution chart Session data can be exported to an excel document by clicking on the Export button Grasp To access the protocols select the Grasp icon in the navigation menu There the user can...

Страница 17: ...n asterisk are the optimal candi dates to achieve a motor response in the movement that is being configured Non activated cathode Activated cathode Blocked cathode CLICK CLICK LONG TOUCH By doing a lo...

Страница 18: ...bjectives It can be used to increase maintain range of motion prevent muscle atrophy etc 3 In patients whose motor threshold is above the pain threshold This protocol can be used to lower the motor th...

Страница 19: ...ation parameters CONFIGURATION BAR Intensity edition Select the desired configuration and stimulation time Select configuration Select the desired movement Flexion Exten sion Select movement Start Sto...

Страница 20: ...R Stimulation parameters Select the configuration to load By default ex cept for the first time the last configuration made for that patient will be loaded Press Play to start the stimulation The conf...

Страница 21: ...on the options Complex 1 Complex 2 and Complex 3 To change the title and image of this movement make a long touch on the title In case of choosing predefined complex movements Open hand Grip Palm gri...

Страница 22: ...ull screen in the selected order There are 3 phases 1 Preparation A 3 second countdown and a dynam ic image of the movement to be performed are shown 2 Realization A descriptive static image of the mo...

Страница 23: ...king on the same image Select the next move clicking on the image of this TOGGLE KEYPAD The Toogle keypad acts as a button and trigger for stimulation By clicking directly on the image of the desired...

Страница 24: ...TECHNICAL SUPPORT 04...

Страница 25: ...the tablet screen Please try again if the error persists after restarting the device and tablet contact Fesia Support with the exact error message Make sure you have checked the following steps before...

Страница 26: ...f the arm is cone shaped Cmin Cmax 0 7 CHOOSE THE M L SIZE INSTRUCTIONS FOR USE Fesia Grasp 51 50 INSTRUCTIONS FOR USE Fesia Grasp SIZE SELECTION GUIDE If after choosing the S M size the textile does...

Страница 27: ...MAINTENANCE 05...

Страница 28: ...h Do not pour too much water on the electrode In case of excessive sweating do not moisturize the electrode Do not use the electrode for more than 15 sessions Do not to extend the life of the elec tro...

Страница 29: ...er is broken This can be due to Scratching the skin too hard Placing the electrode over a cut rash spot or insect bite Shaving the skin using a razor Using old dried out damaged or dirty electrodes Ve...

Страница 30: ...TECHNICAL INFORMATION 06...

Страница 31: ...intensity 0 60mA 1mA resolution for loads 5000 Pulse width 150us 300 us resolution of 5us Pulse frequency 1 40Hz resolution of 1 Hz Maximum output voltage 180V Maximum output frequency 1KHz PARAMETER...

Страница 32: ...nic emissions IEC 61000 3 2 Voltage fluctuations Flickers emis sions IEC 61000 3 3 Class B Class A Fulfill The device is suitable for use in establishments other than domestic and those directly conne...

Страница 33: ...te 1 Ut is the AC mains voltage prior to application of the test level Note 2 At 80 MHz and 800 MHz the higher frequency range applies Note 3 These guidelines may not apply in all situations Electroma...

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