Introduction; What Is The I-One And How Does It Work; Who Can Use The I-One; Who Can Use The - IGEA I-ONE User Manual

IGEA

1. INTRODUCTION

1.1

What is the I-ONE and how does it work?

The I-ONE is a medical device for the treatment of inflammatory and degenerative tissue diseases using low-
frequency electromagnetic fields.
The I-ONE is a therapeutic aid and must be used under a doctor's prescription.
The device consists of a low-frequency pulsed electromagnetic field generator characterised by a pulse signal at a
frequency of 75 Hz, with a pulse width (trigger time) of approximately 1.0 millisecond.
This electromagnetic field is capable of inducing an average electric field of 0.04 mV/cm in the bone tissue, which
represents the active component of the signal and is capable of increasing osteoblast activity.
The electric field focusses on the site to be treated by means of appropriately shaped coils.
The generator is controlled by a microprocessor that constantly monitors the correct functioning of the device,
promptly signalling any anomalies or malfunctions to the patient that may occur during the treatment; to this end,
it is equipped with simple and effective visual and acoustic alarms.
1.2

Who can use the I-ONE?

The I-ONE must be used by people who are capable of independently understanding and implementing the
instructions provided in this manual; otherwise, and if it is being used on children, the I-ONE may only be used under
the supervision of people who are capable of understanding and implementing the instructions provided in this
manual.
1.3

Intended Use

The intended use of the low frequency pulsed electromagnetic field generator for therapeutic use is the treatment
of inflammatory and degenerative tissue diseases, with particular reference to the joints and the stimulation of
osteogenesis. In particular, the I-ONE device, model CBA04 is indicated for:
• Treatment of inflammatory and degenerative tissue diseases
1.4

Device performance characteristics

The device performance characteristics are:
- the ability to generate an electrical signal with the specified characteristics capable of driving a coil and
producing a pulsed electromagnetic field that provides the expected clinical benefits;
- the device must allow the user to activate/deactivate the signal delivery and check the time the treatment
is performed at.
More specifically, the time-varying electromagnetic field generated produces a specific effect on the receptors that
control inflammation. The effect on inflammation, which is related to the agonist activity of adenosine for A2A
receptors, justifies the indication for use in various tissues.
1.5

Treatments that can be carried out with I-ONE Therapy

The main indications for which the I-ONE is used are:
- Ligament reconstruction
- Microfractures of the subchondral bone
- Joint fractures
- Joint inflammatory processes
- Oedema
- Autologous chondrocyte grafts
- Osteochondral grafts
- Early stages of arthrosis
- Meniscectomy
- Algodystrophy
- Knee prosthesis
- Femoro-rotulea syndrome
The coil to be applied to the treatment site has a homogeneous field and does not require a perfectly centred
application on the site to be treated; for this reason the patient is able to perform the application independently,
I-ONE - User Manual
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