EMS EMS560 Bedienungsanleitung

User Manual

EMS560

PRIMO RADIAL SHOCKWAVE

Model 135

OM560EN Iss 3

120

Primo radial shockwave 560 – OM560EN Iss 3

Primo radial shockwave 560 – OM560EN Iss 3 3

Contents

Page

Contents 3

General information & record of amendments 4

Warranty statement 5

Introduction & indications for use 6

Contraindications 7

Accessories 9

Controls and markings 10

Installation 14

Environmental conditions for use and storage 15

Essential performance 15

Operating instructions 16

Shockwave treatment 24

Maintenance 26

Technical specification 28

Appendix A – EMC test levels 29

Appendix B – Warnings and error codes 30

Primo radial shockwave 560 – OM560EN Iss 3

General information

This manual provides the necessary information for the installation and

operation of the Primo radial shockwave 560 unit.

These instructions must be studied before putting the unit into operation.

The information contained in this manual is subject to change without

notice.

No part of this manual may be photocopied, reproduced or translated into

another language without the prior written consent of EMS Physio Ltd.

Record of amendments

ISSUE COMMENTS DATE

1 Initial Issue 10/06/19

2 Updated for SGS CE mark 12/09/19

3 Further edits to 60601-1-2:2015 25/09/19

Primo radial shockwave 560 – OM560EN Iss 3 5

Warranty

This EMS Physio Ltd., (hereinafter called the Company) product is

warranted against defects in materials and workmanship for a period of two

years from the date of shipment. The Company will at its option, repair or

replace components which prove to be defective during the warranty

period, provided that the repairs or replacements are carried out by the

Company or its approved agents.

The Company will consider itself responsible for the effects on safety,

reliability and performance of the product only if:-

assembly operations, re-adjustments, modifications or repairs are

carried out by persons authorised by it,

the product is used in accordance with the instructions for use,

the electrical installation of the relevant room complies with the

appropriate national requirements.

Should the product be returned to the Company for repair it must be sent

carriage paid.

Consumable items, for example, applicator tips and silicone covers are

excluded from the above warranty.

It is intended that the Primo radial shockwave 560 unit is only used by

qualified healthcare professionals such as physiotherapists who have

received training in electrotherapy.

Primo radial shockwave 560 – OM560EN Iss 3

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.

Primo radial shockwave 560 – OM560EN Iss 3 7

Maintenance: For continuous and safe operation, regular maintenance and

inspection by EMS authorized technicians is required. For the maintenance

procedures and schedule, refer to the Maintenance chapter of this manuall.

Coupling media: Water-based ultrasound gel should be used as coupling

media between the primo radial shockwave applicator membrane and

patient skin. If the Primo Radial Shockwave applicator membrane is not

utilised, no coupling media should be applied as it may enter the projectile

chamber and impair performance.

Cleaning: Proper cleaning of the applicator and main unit is required. For

cleaning instructions, refer to the Maintenance chapter of this manual.

Modification of the Primo radial shockwave EMS560 is not permitted and

may result in a hazardous situation.

Contraindications and warnings

Patients in whom pregnancy is confirmed or suspected.

Children under 18 years old.

Contagious skin disease.

Patient with tumor in the area of treatment.

Implanted devices: Do not apply radial waves on any implanted device. To

reduce the incidence of malfunction, a distance of at least 5 cm shall be

kept between the shockwave applicator and the implanted device. For extra

precaution in case of pacemakers or implantable defibrillators, the pulse

generator should be programmed to a single chamber, non-rate responsive

mode (pacemakers) or to inactive mode (implantable defibrillators) prior to

treatment procedure and evaluated for proper function post-treatment.

Applying radial waves in or near an area where a tumour is known to be

present shall be done under the physician discretion.

Do not apply radial waves to areas suffering from superficial vein

thrombosis.

Patients with skin infection in the treatment area should have precautions

taken in order to avoid cross-contamination.

Primo radial shockwave 560 – OM560EN Iss 3

Treatment of the following patients shall be subjected to the treating

physician’s discretion:

Patients having INR > 2.5, prolonged partial thromboplastin time (PTT) or

prolonged bleeding time and platelet count less than 100,000 per microliter.

Patients receiving an anticoagulant or antiaggregant therapy (e.g., aspirin).

Do not apply radial waves to air-filled areas of the body, i.e., intestines or

lungs.

If patient experiences severe pain/discomfort at the application site during

treatment, the intensity level should be decreased to the highest level that

can be tolerated by the patient.

If patient experiences a vaso-vagal reaction during treatment, the patient

should be reclined to a supine position until symptoms disappear.

In case of patient’s history of allergic reaction to alcohol we recommend

using non-alcoholic disinfectants.

Please note that during normal treatment, the applicator will become warm

and the applicator tip may reach 46 Deg C.

Non-continuous operation

The applicator is not intended for continuous operation and at maximum

power a duty cycle of a maximum of 2.5 minutes on and 20 minutes off

between treatments to allow the applicator to cool is recommended.

If this advice is disregarded, a thermal cut out will operate and the

applicator will cease to function – forcing the user to wait until it has cooled

sufficiently.

Adverse events

Potential adverse effects that could occur when using the Primo radial

shockwave treatments include:

Pain.

Petechia.

Superficial hematoma.

Neurosensory conditions: Hypesthesia or Paresthesia.

Rare allergic or sensitive conditions.

Primo radial shockwave 560 – OM560EN Iss 3 9

Accessories supplied as standard

Catalogue Number Description

EMS559 DC power supply base unit 48V

450W

EMS561 Shockwave applicator

A135-3-02 Applicator stand

EMS562 Foot switch

EMS563 Applicator tip 6mm

EMS564 Applicator tip 15mm

EMS565 Applicator tip 25mm

EMS567 Applicator tip membranes X 4

EMS502C EMS coupling medium 250ml bottle

Optional accessories

EMS566 Hard carry case

Supplied with each unit is a detachable mains lead suitable for the country

to which it is delivered. Replacement or additional mains leads are shown

below.

Part Number Description

6-85 UK mains lead

6-112 European mains lead

6-119 North America mains lead

For other countries contact EMS Physio Ltd. or the agent from whom the

unit was purchased.

WARNING: Use of accessories such as the applicator, footswitch or mains

cables other than those specified or provided by the manufacturer of this

equipment could result in increased electromagnetic emissions or

decreased electromagnetic immunity of this equipment and result in

improper operation.

WARNING: Portable RF communications equipment (including peripherals

such as antenna cables and external antennas) should be used no closer

than 30cm (12 inches) to any part of the EMS560 including cables specified

by the manufacturer, otherwise degradation of the performance of this

equipment could result.

Primo radial shockwave 560 – OM560EN Iss 3

Controls and markings

Radial shockwave 560 top

TFT display

with

touchscreen

Base with power supply

On/off button

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