Introduction & Indications For Use - EMS EMS560 User Manual

Introduction
The Primo radial shockwave 560 is a radial wave therapy (RWT) device
designed to deliver extracorporeal radial wave energy created by an
electromagnetic projectile mechanism. Kinetic energy is converted into
impact at the skin surface and dispersed radially into the body with each
pulse. The energy impulse transmitted to the tissue creates the counter-
irritation effect that modulates pain and improves function.
Indications for use
The Primo EMS560 is indicated for applying radial shock wave energy for
pain relief and improved function in the treatment of the following chronic
musculoskeletal conditions: Plantar fasciitis, Achilles tendinopathy, Patellar
tendinopathy and Lateral epicondylitis.
Precautions
Therapy shall be performed by qualified personnel trained and/or
experienced in the use of this device as outlined in an appropriate training
program.
Electromagnetic interference: This device may cause electromagnetic
interference to electronic devices
The emissions characteristics of this device make it suitable for use in
industrial areas and hospitals (CISPR 11 class A). If it is used in a
residential environment (for which CISPR 11 class B is normally required)
this device might not offer adequate protection to radio-frequency
communication services. The user might need to take mitigation measures,
such as relocating or re-orienting the equipment.
This device is suitable for use in hospital environments except for near
active HF surgical equipment or in the RF shielded room of magnetic
resonance imaging equipment where the intensity of EM disturbances is
high.
WARNING: use of this device adjacent to or stacked with other equipment
should be avoided because it could result in improper operation.
Cross contamination: Patients with skin infection in the treatment area
should have precautions taken in order to avoid cross-contamination.
6 Primo radial shockwave 560 – OM560EN Iss 3