EMS EMS560 User manual

User Manual
EMS560
PRIMO RADIAL SHOCKWAVE
Model 135
OM560EN Iss 3
0
120

Primo radial shockwave 560 – OM560EN Iss 3
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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

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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.

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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.

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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.

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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.

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Controls and markings
Radial shockwave 560 top
TFT display
with
touchscreen
Base with power supply
On/off button

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Primo radial shockwave 560 front label
The output socket is for connection of the shockwave applicator
The switch input is for connection of the foot switch
Shockwave
applicator
output socket
IEC symbol
878-01-37
Output
IEC symbol
878-02-03 Type
BF equipment
IEC symbol 348
Attention, consult
accompanying
documents
ISO symbol
7010-M002,
consult
instructions for
use
Switch input
socket

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Primo radial shockwave 560 underside label
Do not dispose of
as unsorted
waste
(2006/96/EC
WEEE Directive)
Serial number
and date of
manufacture
IEC symbol 348
Attention, consult
accompanying
documents
ISO symbol 7010-
M002, consult
instructions for
use
Name and
address of
manufacturer
Model number
and
classification
IEC symbol 878-
02-03 Type BF
equipment

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Primo radial shockwave power supply (EMS559) underside label
Primo radial shockwave power supply back label
Model number
and
classification
Name and
address of
manufacturer
Serial number
and date of
manufacture
IEC symbol 348
Attention, consult
accompanying
documents
ISO symbol 7010-
M002, consult
instructions for
use
Do not dispose of
as unsorted
waste
(2006/96/EC
WEEE Directive)
1
0

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Installation
Upon receipt, check for any visible damage which may have occurred in
transit. If any signs of damage are found then retain all packing material
and inform the carrier and the Company or its agent from whom the unit
was purchased.
The Primo radial shockwave must only be used with an EMS559 power
supply (as supplied with the unit). The cord coming from the back of the
main shockwave unit plugs into the circular connector on the back of the
power supply. A power cord appropriately rated/approved for the country of
use must be used.
The EMS559 power supply must only be connected to a mains supply with
a protective earth conductor. If the integrity of the earth connection is in
doubt, do not connect it to the mains supply (risk of electric shock with type
B applied parts). The unit must not be positioned in such a way that the
mains plug cannot easily be unplugged – the mains plug is the main
disconnect device.
The Primo radial shockwave 560 unit is supplied with a shockwave
applicator and a foot (or hand) operated switch.
Plug the applicator into the output socket on the front right of the unit and
the foot-switch into the socket to the front left.
Be careful not to subject the applicator to rough handling such as dropping
onto a hard surface as this may impair performance.

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Permissible environmental conditions of use:
Temperature 10 to +35°C
Relative humidity 20 to 80%
Atmospheric pressure 700 to 1060hPa
Permissible environmental conditions of transport and storage:
Temperature -10 to +55°C
Relative humidity 10 to 90%
Atmospheric pressure 700 to 1060hPa
Operating altitude 3000m
Extended term transport and storage temperature: 0 to +40°C
Expected service life:
Main unit – 7 years
Applicator 3 years or 2,000,000 shocks whichever comes first
Essential Performance
BSEN 60601-1 defines Essential Performance as:
“Performance necessary to achieve freedom from unacceptable risk”
Functions of the EMS560, the absence or degradation of which could result
in a hazardous situation are:
Maximum frequency 22Hz
Maximum energy 180mJ (per shock)
Maximum Shocks 3000
Loss or degradation of these functions due to EM disturbances (eg.
electrostatic discharges or mains voltage dips) may cause temporary loss
of output but this is not considered to be hazardous.

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Operating instructions
Power on sequence and general information
After the Primo radial shockwave 560 is turned on using the mains switch
on the back of the PSU unit a splash screen appears showing the EMS
company logo.
After a few seconds the unit will give a short beep and display the main
screen.
The main counter (top middle window) reads zero as no shocks have been
produced yet, also a default number of 300 shocks is ready to go but as
none have been triggered yet the usage graphic shows 0%.
Standard user controls
Throughout the operation of the Primo radial shockwave 560 the various
modes and parameter settings are all accessed and changed by touching
the relevant buttons displayed on the touchscreen.
On most display screens touching the back arrow icon in the top left corner
will return the display to the main Home screen.
The on/off button at the bottom right of the top panel can be used to turn off
the display and put the unit into standby mode, pressing it again switches it

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back on. If pressed during a treatment this stops the shock pulses and
causes safe shutdown of the device.
User interface – main screen
The main user-adjustable parameters are described below.
Energy Density per shock =
(energy per shock)/(area of tip).
Automatically recalculated every
time the energy per shock
and/or the
tip type are changed
Burst
on/off
Select shock
frequency
Shock
frequency
Applicator tip
size
selection
Button opens
treatments
screen
Total energy = (energy per shock) X
(number of shocks)/(area of tip)
Output window updates with each
new shock. The number of shocks is
taken from that in the main counter,
and pressing ‘Reset counter’ will set
the Total energy readout back to
zero
Select energy
per shock
Main
cumulative
counter
Treatment counter
and progress icon

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Touch the ‘Set shocks’ button to open this screen –
Type in the desired number of shocks and touch Enter to return to the main
screen. This will be the number of shocks available for that part of the
treatment. Pressing the foot switch will start the treatment and the
treatment counter will count down and the % graphic will show the
proportion of shocks emitted to that of those unused – when it reaches
100% no more shocks will available and operating the foot switch will no
longer produce any more. This is ‘count down’ mode.
Alternatively, entering 0 shocks in the above keypad screen (or leaving it
blank) will result in a blank treatment counter window once ‘Enter’ is
pressed – operating the foot switch will still activate the unit and produce
shocks but there will be no upper limit to the amount available*, the
treatment counter will continue to increment indefinitely as long as the foot
switch is operated. This is ‘count up’ mode.
The main cumulative counter will continue to increment until either the
‘Reset Counter’ button is operated (which will zero it) or mains power is
turned off. This will add up the total number of shocks from several different
treatment parts and will be useful to keep track of the total number when,
say, a certain amount are entered into the treatment counter to be used on
one body area, then a different amount on another etc. The ‘Reset Counter’
button would generally be operated between patients.
The Total energy (actually energy density in mJ/mm2) is calculated by
multiplying the energy (density) per shock by the total number of shocks as
recorded by the main cumulative counter. It therefore tells us the total
energy that has been applied to the patient for that particular treatment
session.
*A temporary warning message will appear after 5000 continuous shocks.

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The energy density per shock depends on the energy per shock (set by the
+ and – buttons) and the size of the applicator tip used (selected by the
button with the applicator tip icon). It is automatically calculated from the
energy per shock (in mJ) divided by the surface area of the selected tip (in
mm2). The tip select button should of course always be set to the size
actually in use on the applicator.
The ‘Freq’ button will select between the four available shock frequencies -
the defaults of these are 8Hz, 10Hz, 15Hz and 22Hz.
The ‘Burst’ button toggle between normal (continuous pulses for as long as
the foot switch is held on) and burst modes, where the default* burst is 8
pulses for every foot switch press. In burst mode it is necessary to keep
pressing and releasing the foot switch to get each burst.
The ‘Treatments’ button, when pressed, opens this screen –
Touching the back-arrow icon in the top left will return us to the main
screen.
Pressing a button on the treatments screen takes us back to a main screen
with the stored parameter settings. If it was a ‘treatment suggestion’ button
the condition title will be shown in the bottom-right corner, and the default
settings for that condition will be loaded. Parameters are still adjustable as
the user may wish to ‘ramp up’ the shock energy or frequency during a
treatment session, but any changes will not be saved.

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Example: Treatment suggestion - Plantar Fascitis:
Selecting a ‘User program’ will take us to a main set-up screen containing
the parameter settings last saved. All parameters are adjustable and can
be stored when required by pressing and holding the ‘Title’ button in the
bottom-right corner for a few seconds (the word ‘Saved’ will flash up).
These saved parameters are remembered after main power is switched off.
Example: User program 1: