9
MTS_OW100_IFU-orthogold100-US-K182682_A
1. Introduction
This manual instructs the user in the proper use and operation of the of the
OrthoGold100
®
device. Please read these instructions carefully before starting treatment.
The user must thoroughly understand the information presented in this manual and
inform the patient of all risks associated with the treatment. Additionally, regular
maintenance of the device must be completed according to these instructions.
This instruction for use indicates the model name OW100-US also as
OW100 for simplification.
2. Device Information
2.1
Indications for Use
The OrthoGold100
®
is intended for the activation of connective tissue.
2.2
Contraindications
Contraindication
– A contraindication indicates a situation in which the device should not be used.
Do not use the OrthoGold100
®
in patients with pacemakers or implantable
defibrillators.
Do not use the OrthoGold100
®
in patients who are using devices which are
sensitive to electromagnetic radiation.
Do not use the OrthoGold100
®
in confirmed or suspected pregnancy.
Do not use the OrthoGold100
®
close to the reproductive system in females of
childbearing potential. The application of acoustic waves to this patient population
could possibly result in irreversible damage to the female reproductive system and
to the unborn fetus in an undiagnosed pregnancy.
Do not use the OrthoGold100
®
for the treatment of vertebrae, skull bones and
ribs.
Do not adjust the therapy beam on internal organs (especially lungs).
Do not use the OrthoGold100
®
for the treatment of infected pseudarthrosis in the
acute state.
Do not use the OrthoGold100
®
for the treatment of patients with tumors.
Do not use the OrthoGold100
®
for the treatment of patients with severe
coagulation disorders.
Do not use the OrthoGold100
®
for extracorporeal acoustic wave lithotripsy
Do not use the OrthoGold100
®
for the treatment of patients younger than 18
years or of patients with open epiphyseal plates.
Do not direct the acoustic waves on large nerves.
Do not direct the acoustic waves on large vessels.
