EMS MEGAPULSE SENIOR 265 User manual

User Manual
EMS265
MEGAPULSE SENIOR
Model 92
1639

OM265EN issue 16
2

OM265EN issue 16 3
Contents
Page
Contents 3
General Information 4
Record of Amendments 4
Warranty 5
Introduction 6
Indications for use 8
Precautions 9
Contraindications 13
Accessories 14
Controls and Markings 15
Installation and environmental 19
Essential performance 20
Operating Instructions 21
Maintenance 37
Troubleshooting 38
Appendix A: Technical Spec. 39
Appendix B: EMC Table 41

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General Information
This manual provides the necessary information for the installation
and operation of the Megapulse Senior 265.
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 – 10 Monochrome display version 08/12/2006
11 Updated for new GUI 27/12/2014
12 Updated for new top panel 07/12/2016
13 Precautions amended 05/10/2017
14 Edited post safety report 28/11/2017
15 Power limiting added 24/07/2018
16 Updated for new NB number 20/04/2020

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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,
only if the product is used in accordance with the instructions for
use,
only if 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, electrodes, electrode covers and
batteries, are excluded from the above warranty.
It is intended that the Megapulse Senior 265 is only used by qualified
healthcare professionals such as physiotherapists who have
received training in electrotherapy.

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Introduction
The Megapulse 265 is a continuous and pulsed shortwave therapy
unit.
Shortwave therapy can be applied to a wide range of conditions with
successful outcomes. These include acute and subacute traumatic
and inflammatory conditions, chronic rheumatoid and arthritic
conditions, resolution of haematomas and for pain relief.
Shortwave refers to electromagnetic radiation in the frequency range
2 to 100 MHz. Shortwave therapy is the application of
electromagnetic energy to the body at shortwave frequencies. At
these frequencies the electromagnetic energy is converted to
thermal energy by the induction of circulating currents in the tissue
and dielectric absorption in insulating tissue. Shortwave therapy units
may produce output power levels of up to 500W providing significant
heating to the area of the body being treated. For this reason the
treatment is often called shortwave diathermy (through heating). To
avoid equipment such as shortwave therapy units interfering with
radio communications, certain frequency ranges are designated by
international agreement as ISM (Industrial, Scientific and Medical)
bands. These are shown in the following table:-
Centre Frequency
MHz
Frequency Range
MHz
Maximum
Radiation Limit
6.78 6.765-6.795 Under Consideration
13.560 13.553-13.567 Unrestricted
27.120 26.957-27.283 Unrestricted
40.680 40.66-40.70 Unrestricted
433.92 433.05-434.79 Under Consideration
915 902-928 Unrestricted
2450 2400-2500 Unrestricted
5800 5725-5875 Unrestricted
24125 24000-24250 Unrestricted
61250 61000-61500 Under Consideration
122500 122000-123000 Under Consideration
245000 244000-246000 Under Consideration

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Shortwave therapy equipment normally uses the band centred on
27.12 MHz. This corresponds to a wavelength, in a vacuum, of
approximately 11 metres.
Shortwave therapy is normally applied at a level which produces
detectable heating and the benefits are those associated with the
heating effect - encouragement of healing, pain relief, reduction of
muscle spasm, increase in mobility etc.
The difference between shortwave therapy and other methods of
heating is that it provides “deep heat”. Other heating techniques such
as infrared therapy, hot-packs etc., provide the heat externally
whereas shortwave therapy generates heat within the tissue.
As with any electrotherapy, there are several potential dangers
associated with shortwave therapy. Since relatively high powers are
used, there is the possibility of producing burns if the patient is
unaware of the heat due to reduced thermal sensation, or if the
patient does not know what to expect during treatment. Metal in
treatment area will provide low impedance paths to the induced radio
frequency current, producing local heating and the possibility of
burning. In particular, treatment should never be given in the area of
metal implants, metal jewellery, buckles etc must be removed and
treatment must never be given with the patient on metal framed
couches or chairs. Patients with implanted electronic devices such
as cardiac pacemakers must not be treated. Other equipment,
including patient connected devices, may be adversely affected
when in close proximity to shortwave therapy equipment.
Pulsed Shortwave Therapy
Conventional shortwave therapy equipment described above,
produces a continuous wave output at 27.12 MHz. Pulsed shortwave
therapy equipment delivers the energy in pulses or bursts of
shortwave energy. The pulses are typically 20 to 400 microseconds
in duration (pulse width) and are repeated with a frequency of 5 to
800 Hz (pulse frequency). As with other modalities such as
ultrasound, it is found that delivering the energy in pulses is often
therapeutically more beneficial that providing the same amount of
energy in continuous wave form. Pulsed shortwave therapy appears
to be effective for many conditions especially in the early stages of
recovery.

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Because the output is pulsed, the average output power levels can
be very low (less than 1W) and still produce effective treatment.
However, the patient is unlikely to sense any warming effect with
sub-thermal settings below about 20W average power.
The Megapulse Senior 265 in pulsed mode and with a Monopulse
applicator provides a peak power of up to 200W and average powers
from a few mW to 64W.
As the power levels in pulsed mode are lower than with conventional
shortwave therapy equipment, some of the potential dangers
associated with the modality no longer apply. At average powers of
less than 5 W, treatment may be given over areas containing metal
implants, through wound dressings or plasters, and on couches or
chairs with metal frames. A list of necessary precautions and
contraindications is provided in the following sections.
Indications for use
The EMS265 may be used to provide shortwave therapy in the
treatment of soft tissue injuries in acute and chronic conditions. The
following specific conditions are indicated:
Acute – Post trauma to reduce pain, swelling and oedema.
Chronic – To reduce pain, improve tissue extensibility and improve
function and range of movement.

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Precautions
The function of certain implanted electrical devices, for example
pacemakers, may be adversely affected during treatment with
shortwave therapy. In case of doubt, the advice of the physician in
charge of the patient should be sought.
The function of other patient connected equipment may be adversely
affected by the operation of shortwave therapy equipment.
Hearing aids should be removed.
Treatment should not be given through clothing although it is
permissible to treat through a dressing or plaster in pulsed modes.
In pulsed modes areas containing internal metallic implants may be
treated at low power levels (less than 5 W average power) without
special precautions.
At average power levels above 5 W the following additional
precautions apply:
External conductive material should be removed from the immediate
treatment area.
Patients should not be allowed to come into contact with conductive
parts which are earthed or which have an appreciable capacitance to
earth and which may provide unwanted pathways for the radio-
frequency current. In particular, beds or chairs with metal frames
should not be used.
The connecting cables associated with electrodes should be
positioned in such a way that contact with the patient or conductive
or energy absorbing objects is avoided. The Megapulse Senior 265
has cable retaining clips on both electrode arms.
The electrode cables should be positioned so that they do not
contact the body work or top panel of the equipment during use.
Maximise the distance between the leads and ensure that they never
touch during the treatment to avoid any inductive effect. Avoid any
unnecessary user contact with the leads during treatment.

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Make sure that the leads are properly connected and that they are
kept away from each other to avoid over-heating. Never let them
cross over.
Position the arms as shown in the
picture on the left. Never treat in
reverse. Keep the leads as far apart
as possible from each other and the
machine and its casing during
treatment.
incorrect arm
position

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Do not allow the leads to contact the body work or top panel of the
equipment during use
The electrode cables and plugs may get hot when used at high
output levels for prolonged periods. Allow to cool after treatment
before disconnecting.
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.

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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.
Cleaning and care of treatment Electrodes
The electrodes may be disinfected using a 70% v/v aqueous solution
of isopropyl alcohol. They are NOT suitable for steam sterilisation or
for disinfectants containing sodium hypochlorite.
N.B. Isopropyl alcohol is flammable and should be kept away from
naked flames. Isopropyl alcohol must not be brought into contact
with eyes or mouth.
The unit may be cleaned by wiping over with a damp cloth. The use
of abrasive materials and cleaning solvents should be avoided.
Regularly (at least monthly) inspect all treatment leads, cables and
connectors for signs of damage.
Modification of the Megapulse Senior 265 is not permitted and may
result in a hazardous situation.

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Contraindications
Tumours, due to the risk of increased growth or metastatic activity.
Pregnancy, do not treat the lower abdomen, back or pelvis.
Menstruation, do not treat lower back or abdomen due to risk of
increased bleeding or pain.
Cardiac conditions, do not treat the chest area or near the cervical
ganglion.
Cardiac pacemakers, especially demand type, or any other
implanted electronic device.
Patients with reduced thermal sensitivity in the proposed
treatment area should not be treated with shortwave therapy.

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Accessories
For continued safety, only electrodes and cables supplied by EMS
Physio Ltd. should be used with the Megapulse Senior 265.
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.
For other countries contact EMS Physio Ltd. or the agent from whom
the unit was purchased.
WARNING: Use of accessories such as electrodes 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 EMS2565
including cables specified by the manufacturer, otherwise
degradation of the performance of this equipment could result.
Catalogue
Number
Description
SLA990 Monopulse applicator
SLA991 Flexipulse applicator
SLA992 Pair of 100mm capacitive electrodes (standard
issue)
SLA993 Pair of 50mm capacitive electrodes
SLA996 Pair rubber electrodes,180x120mm, with 4 felt
spacers
SLA9960 2 felt spacers for SLA996
SLA997 Pair rubber electrodes,260x180mm, with 4 felt
spacers
SLA9970 2 felt spacers for SLA997
EMS Part
Number
Description
6-85 UK mains lead
6-112 European mains lead
6-119 North America mains lead

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Controls and Markings
Megapulse Senior 265 control panel
Fig. 3 Megapulse Senior 265 control panel
Stand-by/On
LED
Control knob
IEC symbol
848-01-26
variability in
steps
LCD touch
screen
ON/OFF
Button
IEC symbol 5007

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Fig. 3 Megapulse Senior 265 rear view
Fuse label
BNC connector for
Monopulse
applicator (optional)
Output
sockets for
electrodes
Rear
panel label
On/Off
switch Mains inlet

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Fig. 5 Fuse Label
The fuse label indicates the type and rating of the mains fuses
ISO 7000 -
1641 consult
instructions
for use
Serial number
and date of
manufacture
IEC symbol
878-02-03
type BF
equipment
IEC symbol
878-03-04
non-ionising
radiation
CE mark
showing
conformity
to
93/42/EEC
Name and
address of
manufacturer
Fig. 4 Rear Panel Label
Model
number and
classification
Do not dispose
of as unsorted
waste
(2006/96/EC
WEEE Directive)
IEC symbol 348 Attention.

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Treatment
light
Label
Serial number and
date of
manufacture
Fig. 6 Monopulse Applicator
Fig. 7 Monopulse Label
IEC symbol
878-03-04
non-ionising
radiation
IEC symbol
878-03-01
dangerous
voltage

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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, within two working days, the carrier and
the Company or its agent from whom the unit was purchased.
If not already fitted, connect a suitable plug to the mains cable. The
plug must have provision for an EARTH (GROUND) connection. The
mains cable has the following colour code: BROWN is LIVE (LINE),
BLUE is NEUTRAL and GREEN/YELLOW is EARTH.
The Megapulse Senior 265 unit 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 the unit to the mains supply.
The Megapulse Senior 265 unit must not be positioned so that it
becomes difficult to access the mains on/off switch at the back of the
unit or the mains plug at the end of the mains cable (to facilitate
disconnection).
At the end its life, the Megapulse Senior 265 should not be disposed
of as unsorted general waste.
Advice on appropriate disposal is available from EMS Physio Ltd.
Permissible environmental Conditions for Transport and
Storage
Temperature -10 to +35°C
Relative Humidity 5 to 95%
Atmospheric Pressure 500 to 1060 hPa
Permissible environmental Conditions for Use
Temperature 10 to +35°C
Relative Humidity 10 to 80%
Atmospheric Pressure 500 to 1060 hPa
Expected service life:
7 years

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Essential Performance
BS EN 60601-1 defines Essential Performance as:
“Performance necessary to achieve freedom from unacceptable risk”
Functions of the EMS265, the absence or degradation of which could
result in a hazardous situation are:
Timer: The treatment shall be limited to a maximum of 30 minutes.
Maximum output power: Shall not exceed 1200W pulsed
Shall not exceed 480W continuous
The device is therapeutic. Provided the treatment time or output
powers are not exceeded then death or serious deterioration of
health is very unlikely to occur in normal operation. If the treatment is
halted for any reason, then there will be no hazardous situation.
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.