Fesia Grasp Manuale utente

Instructions for Use

Fesia Grasp

Instructions for Use

Guide

Fesia Grasp

Rev.: 3.00

Date: 02/2020

English

MANUFACTURER:

Fesia Technology S.L.

Pº Mikeletegi, 1

20009 Donostia / San Sebastián

Spain

MAIL: support@fesiatechnology.com

WEB: www.fesiatechnology.com

SUPPORT: https://fesiatechnology.freshdesk.com/support/home

COMERCIALIZED BY:

Fesia Technology S.L.

Pº Mikeletegi, 1

20009 Donostia / San Sebastián

Spain

0051

 
 
INDEX 
1General information........................................................................... 1 
1 Indications of use .................................................................................................................................................1 
2 Contraindications .................................................................................................................................................1 
3 Warnings...............................................................................................................................................................1 
4 Precautions...........................................................................................................................................................1 
5 Adverse reactions.................................................................................................................................................2 
2Symbols and definitions ..................................................................... 3 
3Fesia Grasp system description .......................................................... 5 
1 General description..............................................................................................................................................5 
2 System components.............................................................................................................................................6 
4Fesia Grasp operating instructions ..................................................... 7 
1 Placement.............................................................................................................................................................7 
2 Turning On/Off .....................................................................................................................................................8 
3 Luminous/acoustic indicators..............................................................................................................................9 
3.1 Stimulator.........................................................................................................................................................9 
4 Battery charge ......................................................................................................................................................9 
5 Electrode replacement ........................................................................................................................................9 
6 Skin care..............................................................................................................................................................10 
5Software application ........................................................................ 11 
1 General description............................................................................................................................................11 
2 Installation ..........................................................................................................................................................11 
3 Log in...................................................................................................................................................................11 
4 Logging in............................................................................................................................................................12 
5 Bluetooth connection to the device..................................................................................................................13 
5.1 Connecting to a device..................................................................................................................................13 
6 Patient management .........................................................................................................................................13 
6.1 Creating a Patient Profile ..............................................................................................................................13 
6.2 Selecting a patient .........................................................................................................................................14 
7 Fesia Grasp protocols.........................................................................................................................................15 
8 Training protocol................................................................................................................................................15 
9 Grasp protocol....................................................................................................................................................17 
9.1 Configuration .................................................................................................................................................17 
9.2 Grasp ..............................................................................................................................................................19 
10 Sessions...............................................................................................................................................................20 
11 Settings ...............................................................................................................................................................22 
12 Bluetooth connection/disconnection ...............................................................................................................22 

 
 
5.13 Daily use..............................................................................................................................................................23 
6Maintenance and cleaning ............................................................... 25 
a) Transport.................................................................................................................................................................25 
b) Disposal of equipment and accessories.................................................................................................................25 
7Troubleshooting............................................................................... 26 
8Technical information ...................................................................... 27 
a. Stimulator specifications ........................................................................................................................................27 
b. Electrode specifications..........................................................................................................................................28 
c. Charger specifications ............................................................................................................................................28 
d. EMI Tables...............................................................................................................................................................28 
8.1.1 Guidance and manufacturer’s declaration– electromagnetic emissions...................................................29 
8.1.2 Guidance and manufacturer’s declaration – electromagnetic immunity ..................................................30 
8.1.3 Recommended separation distance between portable and mobile rf communications equipment and the 
Fesia Grasp device.......................................................................................................................................................31 
9Contact information......................................................................... 32 
 
 
 

Instructions for Use: Fesia Grasp

1GENERAL INFORMATION

1.1 Indications of use

Fesia Grasp is an electrical stimulation device designed to provide flexion and extension of the wrist and fingers in people

with motor dysfunction of the hand after an injury or disease of the central nervous system. During grasping, Fesia Grasp

electrically stimulates the appropriate muscles of the affected forearm to provide flexion and extension of the wrist and

fingers to improve the grip of the individual. Clinical benefits of functional electrical stimulation may also include

reinforcement of motor relearning, muscle strengthening, prevention/delay of muscle atrophy, increased local blood

flow and maintenance/increase of range of motion.

1.2 Contraindications

•People with cardiac pacemakers or other electrical or metallic implants, unless recommended

by a physician.

•People with severe epilepsy or a recent history of frequent seizures.

•Tumors or cancerous lesions in the area where electrical stimulation is applied.

1.3 Warnings

•Do not use this device to control machines, drive or perform any activity where an involuntary

movement could pose a risk of injury.

•Do not place the electrode on the head, eyes, mouth, throat (carotid sinus), chest or back.

Place the electrode on the Forearm only as indicated in the manual.

•Simultaneous use of Fesia Grasp and other high frequency medical devices could cause skin

burns in the electrode area and could damage the stimulator.

•Using the system less than one meter away from shortwave or microwave therapy equipment

may cause instability in the output of the stimulator.

•Electrode placement near the thorax may increase the risk of atrial fibrillation.

•Do not attempt to repair the Fesia Grasp or open the stimulator under any circumstances. In

case of breakdown contact Fesia technician.

•Prolonged use of the electrode increases the risk of skin irritation.

•Use of worn electrodes could cause skin burns or loss of function of the system.

•Improper use or use of a defective system may cause skin burns, muscle damage or falls.

1.4 Precautions

•This device must be used under the supervision of a physician or clinician, physiotherapist or

care giver and may only be operated by personnel trained specifically for this purpose.

•The system should not be used if there is presence of lesions and/or wounds of any kind (skin,

muscle, tendon, bone...) in the area and at the time of applying electrical stimulation.

•Do not use this device if you experience any symptoms of malfunction or if any of the

components are in poor condition.

•Should not be exposed to liquids and splashes.

•Should not be exposed to extreme temperatures.

•Should not be exposed to direct sunlight.

•Should not be used near flammable products.

•Store the system under protection from moisture, dust and direct sunlight.

•Only use electrodes supplied by Fesia.

•Use only the charger and charging cable supplied and / or approved by Fesia.

Instructions for Use: Fesia Grasp

•This device should be kept out of reach of children.

•Caution when using the system if you have heart disease, epilepsy, or vascular or circulation

problems is recommended.

•Do not turn on the stimulator until it is properly placed on your arm.

•The electrode is personal, it should not be exchanged between different people.

•Make surethat the stimulator the sensor is charged before each use.

•The long-term effects of chronic electrical stimulation are unknown.

•The safety of using electrical stimulation during pregnancy has not been determined.

1.5 Adverse reactions

•Electrical stimulation could cause an uncomfortable feeling or very mild pain in the first usess

until the feeling becomes familiar.

•It is normal for the area where stimulation has been applied to appear red after removing the

device, this redness should disappear in about an hour.

•Electrical stimulation or gel contact with the skin may cause irritation or allergic reaction on

the contact surface in some cases.

•The patient should immediately stop using the system in the following cases:

•Redness or irritation at the site of application of stimulation for more than one hour

after removing the electrode.

•Blisters or sores in the area of application of stimulation.

•Feel a significant increase in muscle spasticity.

•Tachycardias heart feels stress or during stimulation.

•It has swelling of the forearm, wrist or fingers.

Instructions for Use: Fesia Grasp

2SYMBOLS AND DEFINITIONS

Symbol

Meaning

Caution

0051

Complies with European Medical Device Directive

Manufacturer and date of manufacture

Device reference number

Serial Number

FWxx-aassyy

xx →Device version

aass →aa (year) ss (week) of fabrication

Yy →Correlative number of the same batch

Consult the instructions

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

Type BF applied parts

Continuous load current

Non-Ionizing Radiation

Instructions for Use: Fesia Grasp

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

Table 2-1: List of Symbols.

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