Use Instructions

ELST026-AUM001-V0.6.2 Page 9 of 68
1 SAFETY
1.1 General
1.1.1 Intended use
The gymna Acure device series is intended for the application of Percutaneous Electrolysis, a
progressive application technique in the field of electrotherapy.
A galvanic current is applied to the patient by the use of an acupuncture needle electrode,
functioning as the cathode (negative electrode) in the electrical circuit.
For the anode (positive electrode) a large size rectangular shaped silicone rubber electrode
is used, together with a well moistened sponge making direct contact to the skin surface.
It is important that the silicone rubber electrode and well moistened sponge are placed at
short distance with respect to the pathological area to be treated.
Making use of the fixation strap allows short interpolar distances, independently of the treat-
ment location.
The needle puncture must be inserted under echography guidance in order to apply the cur-
rent exclusively to the degenerated/damaged tissue.
The application produces an electrochemical reaction (electrolysis) in the treated area and
initiates a local inflammatory response necessary for tissue regeneration leading to tissue
recovery.
Galvanic Electrolysis is a possible therapy technique intended for patients (preferred age
from 18) suffering from:
 Chronical tendinopathies
 Soft tissue injuries (muscle, tendons, ligaments, fasciae)
 Trigger points (release of trigger point tension by applying dry needling)
The intended users are physiotherapists and medical degree doctors who have the legal
competence in the country where they practice to perform this treatment.
The gymna Acure device series may only be operated by health care professionals men-
tioned above;
 after thoroughly reading and understanding the content of these instructions for use
 after being trained and instructed in the application of the Galvanic Electrolysis tech-
nique
 when qualified in applying “ultrasound imaging” specific for musculoskeletal
structures, to obtain:
o precise localization of the pathologic area to be treated
o correct penetration and verification of the acupuncture needle position
o correct follow up during the treatment application
o verification that the electrolysis effect covers the whole intended pathologic
area becoming hyperechogenic
The user is responsible for complying with all applicable laws and regulations including appli-
cable safety regulations related to the correct use and maintenance of the gymna Acure de-
vice. The gymna Acure device for the application of Percutaneous Electrolysis is designed to
be used in the framework of professional healthcare activities in environments like surgeries
in residential area, physiotherapists practice, sport facilities, hospitals excluding OR and
shielded rooms for MRI.