What is OsteoBit® therapy?
OsteoBit® therapy is a bone growth stimulation device which enhances fracture healing.
When OsteoBit® therapy indicated?
If, after trauma a fracture does not show progression towards healing after more than 3 months, OsteoBit® therapy can be adopted to trigger osteogenesis and to finalise the repair process.
How does OsteoBit® therapy work?
OsteoBit® therapy generates a capacity coupling electrical stimulator with osteogenetic and anti-inflammatory activities.
The treatment efficay depends of the physical parameters of the signal: pulse train signal with frequency 12,5 Hz and duty cycle of 50%. Every single pulse train is made up of a sinusoidal signal of 60 kHz (patented).
In summary, OsteoBit® therapy biophysical signal acts on the cell membrane favoring the release of calcium ions from the endoplasmic reticulum.
The localised increase in calcium triggers the bone repair process.
How to know if OsteoBit® therapy is working properly?
Switch on the OsteoBit® therapy by moving the switch to position “I”. Yellow and red indicators will come on, and the buzzer will emit a short buzz indicating that the system is on and functioning.
The device will then take a few seconds in order to check that the electrodes are correctly applied to the body (continuous yellow indicator light on) and once this test is completed the treatment commences (flashing yellow light).
The correct operating procedure is indicated by the flashing yellow LED (the flashing yellow light indicates the correct mode for therapy.
Once the treatment session is over, the patient should simply switch the generator off moving the switch to the “O” position. All the indicator lights will then be off.
Is OsteoBit® therapy safe?
Yes. Its biological and electrical safety are widely documented.
Thousands of patients have successfully used OsteoBit® therapy in the absence of negative side effects.
OsteoBit® therapy is manufactured in compliance with the IEC 60601-1 standards, meets the requirements of directive 93/42/EEC and it is CE0051 marked.
What does OsteoBit® therapy feel like and what effect does it have on daily activities?
The patient does not feel the presence of the electromagnetic field generated by OsteoBit® therapy.
The treatment does not interfere with daily activities.
To guarantee the effectiveness of the therapy, the treatment parameters (in compliance with the CEI EN 60601-1-11 standard) are preset and can not be changed, even accidentally, by the patient.
How long does daily treatment last?
Daily treatment with OsteoBit® therapy must be at least 8 hours (non necessarily consecutive) and can be done during the night hours.
The attending physician will specify the total duration of the therapy in accordance to the pathology being treated.
Should OsteoBit® therapy be used at the same time every day?
No, treatment can be carried out at any time of the day.
Daily treatment may be split into several shorter sessions, provided they are at least 2 hours per session.
What happens if I miss a treatment session?
It is advised to recommence the treatment program as soon as possible.
How long does healing take with OsteoBit® therapy?
Treatment length depends on the severity of and length time since fracture.
The doctor prescribes the duration of the therapy based on his experience and on the results of clinical trials.
Before discontinuing therapy, even if there are clear signs of improvement, it is always necessary to firstly consult your doctor.
The constant daily use of OsteoBit® therapy and the continuity of treatment until recovery is essential to promote the healing process.
Can OsteoBit® therapy be used by patients with a pace-maker?
Yes, however coils should be positioned at least 50 cm away from pace-maker.
In this situation, Cardiologist advice is recommended.
Can OsteoBit® therapy be used during pregnancy?
The effects of OsteoBit® therapy during pregnancy have not been investigated and, therefore, Physician advice is recommended.
Does OsteoBit® therapy need special care or specific maintenance?
OsteoBit® therapy is prepared and shipped to patients ready for use. No intervention or maintenance is required.
To guarantee the reliability of performance, OsteoBit® therapy should be subjected to ordinary maintenance procedures and a control of the operating parameters (to be performed by the IGEA Service Centre) every 24 months of use (Guide IEC 62-122).
Does OsteoBit® therapy have contraindications or side effects?
OsteoBit® therapy has no contraindications or side effects.
The experience gained in treating thousend of patients guarantees the safety of all IGEA therapies.
I am a cancer patient, can I use OsteoBit® therapy?
In patients with oncological diseases the use of OsteoBit® therapy is not contraindicated.
However, we would advise you to consult your doctor.