EMS Physio EMS960 User manual

User Manual
EMS960/970
PRIMO INTERFERENTIAL &
MULTIDYNE
Model 122/123
1639

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OM960/970EN Iss 9
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Contents
Page
Contents 3
General information 4
Record of amendments 4
Warranty 5
Introduction and indications for use 6
Contraindications 8
Accessories 9
Controls and markings 11
Installation 15
Operating instructions 17
Maintenance 45
Appendix A –Overview of treatment modality 46
Appendix B - Technical specification 48
Appendix C - EMC Table 60
Appendix D –Electrotherapy chart 61

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General information
This manual provides the necessary information for the installation and
operation of the Interferential 960 and Multidyne 970 Units.
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 09/09/11
2 Updated to show latest images 24/10/12
3 Declaration of conformity revised 26/06/14
4 Updated for colour TFT GUI 11/05/17
5/6 Minor edits 15/11/18
7 Corrections 14/12/18
8 Updated for new NB number 09/04/20
9 Updated for independent channel stim. 17/01/22

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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 Interferential/Multidyne 960/970 unit is only used by
qualified healthcare professionals such as physiotherapists who have
received training in electrotherapy.

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Introduction
The Interferential 960 provides Interferential 4-pole and two independent
channels of 2-pole and/or Medi-Wave electrotherapy only.
The Multidyne 970 provides two independent electrical stimulation
channels each with a complete range of low and medium frequency
waveforms (including Interferential) for electrotherapy and electro-
diagnostics. The units may be powered from a (specific) desktop mains to
DC PSU or from a suitable external DC power bank.
Indications for use
Voltage and current waveforms may be used to provide Neuro Muscular
Electrical Stimulation (NMES) and relief from musculoskeletal pain.
NMES may be used for muscle strengthening and rehabilitation in
otherwise healthy subjects recovering from surgery, for muscle
strengthening for critically or chronically ill patients or to (re)train weak or
ineffective muscles.
Pain relief may be appropriate post-surgery during rehabilitation, or for
relief from chronic conditions such as osteoarthritis.
The various output waveforms available from the units are suitable for
either NMES and/or pain relief as shown in the chart in Appendix D on
page 61.
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.

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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.
Consideration must be given to the current densities for any electrode used
with the 960/970 Unit. Current densities greater than 2 mA rms/cm2are not
recommended because of the risk of burning. All the standard EMS
conductive rubber electrodes may be used up to the maximum output of
the unit without exceeding this figure. When using other electrodes, the
maximum safe output current should be assessed before use. First
estimate the effective contact area of the electrode in square cm, and then
apply the following formula: -
rms output current (mA) = Area of electrode (cm2) x 2
The ratio of the rms to the peak current for the different operating modes is
given in the technical specification section of this manual.
The output indication on the display shows the peak output voltage or the
peak output current in mA depending upon the selected mode of operation.
When using direct current, extreme care must be taken to ensure the
patient's safety from electrochemical burning. In particular care must be
taken to avoid uneven pressure on the electrodes causing high local
current density.
Electrodes must not be applied where there are cuts or abrasions.
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 section of this manual.
Cleaning: Proper cleaning of the electrodes and main unit is required. For
cleaning instructions, refer to the Maintenance chapter of this manual
Modification of the EMS960/970 is not permitted and may result in a
hazardous situation.

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Contraindications
Acute sepsis, due to the risk of spreading infection.
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, across the heart or near
the cervical ganglion –may cause cardiac fibrillation.
Cardiac pacemakers, especially demand type, or any other implanted
electronic device, unless specialist medical opinion has first been obtained.
Febrile conditions
Large open wounds in treatment area
Dermatological conditions in treatment area
Thrombosis
Hypersensitivity or fear of electrical treatments
Any patient who cannot understand the nature of the treatment, e.g.
young children, very old or senile patients who cannot report back
adequately or understand the potential dangers. This may apply equally to
persons who do not speak the same language as the therapist.
Severe hypotension/hypertension, do not treat in the region of the lower
cervical spine.
If in doubt the patient's physician should be consulted.
Electrodes should never be placed so that the applied current goes
across or through the head, eye, front of the neck (especially the
carotid sinus), upper back or chest.
Electrodes must never cover the mouth.

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Accessories supplied as standard
Catalogue
Number
Description
SLA9000
DC Power supply 18V 60W
PMA3055
Patient lead (4 way –yellow and blue
connecting cables included)
NC3053A
4 medium sponge electrode covers (for
NC3053B)
NC3053B
4 medium (100 x 70 mm) conductive rubber
electrodes
DU2
2 Stretch bandages 1200 x 75 mm
Optional accessories
EMS530
Primo shoulder bag
EMS158
Primo trolley
NC3052A
4 small sponge electrode covers (for NC3052B)
NC3052B
4 small (70 x 50 mm) conductive rubber
electrodes
NC3054A
4 large sponge electrode covers (for NC3054B)
NC3054B
4 large (130 x 100 mm) conductive rubber
electrodes
NC3041
Electrode handle (for circular pad & ball
electrodes)
NC3042A
Connecting cable for electrode handle
NC3046
Circular pad electrode 12 mm diameter
NC3048
Circular pad electrode 37 mm diameter
NC311A
Ball electrode for muscle testing
DU1
Stretch bandage 600 x 75 mm
DU4
Stretch bandage 600 x 50 mm
A range of single-patient self-adhesive electrodes is available
Catalogue Number
Description
RB410
33 x 54 mm (pack of 4)
RB430
50 x 50 mm (pack of 4)
RB440
80 x 100 mm (pack of 2)
RB450
25 mm diameter round (pack of 4)

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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.
EMS 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. (contact details on page 45) 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 EMS960/970 including cables
specified by the manufacturer, otherwise degradation of the performance of
this equipment could result.

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Controls and Markings
Interferential/Multidyne 960/970 Top
IEC symbol
848-01-26
variability in
steps
Output control
knob
On/Off button
TFT display
with
touchscreen

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Interferential 960/Multidyne 970 Front Label
IEC symbol
878-02-03 Type
BF Equipment
IEC Symbol 348 Attention,
consult accompanying
documents
Stimulator
output socket
ISO symbol 7010-M002
Instructions for use
IEC symbol
878-01-37
Output

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Multidyne 970 Underside Label (Model 960 is identical)
Do not dispose of as
unsorted waste
2006/96/EC
WEEE Directive)
Name and
Address of
Manufacturer
IEC symbol 348 Attention,
consult accompanying
documents
ISO symbol 7010-
M002
Instructions for use
Model
number
and
classification
Serial number
and date of
manufacture
Stimulation output
levels

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Patient Lead (PMA3055)
Electrode connecting
cables

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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 within two working days.
The Primo Interferential 960/Multidyne 970 must only be used with an EMS
SLA9000 power supply (as supplied with the unit) which is connected to a
mains supply of 100-240V ac. A power cord appropriately rated/approved
for the country of use must be used.
The SLA9000 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 Interferential 960/Multidyne 970 unit is supplied with four
medium-sized electrotherapy electrodes with their associated patient lead.
Plug the patient lead into the socket on the front of the unit and connect the
electrodes to the yellow and blue cables.
Operation of the unit in close proximity (less than 1 metre) to shortwave
therapy equipment or radio-frequency mobile communication equipment
could result in the output of the Interferential 960/Multidyne 970 being
affected.
Permissible environmental conditions of use:
Temperature 10 to +35°C
Relative humidity 10 to 80%
Atmospheric pressure 500 to 1060hPa
Permissible environmental conditions of transport and storage:
Temperature -10 to +35°C
Relative humidity 5 to 95%
Atmospheric pressure 500 to 1060hPa

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Expected service life:
7 years
Essential Performance
BSEN 60601-1 defines Essential Performance as:
“Performance necessary to achieve freedom from unacceptable risk”
Functions of the EMS960/970, the absence or degradation of which could
result in a hazardous situation are:
Maximum stimulation output 100mA CC or 140V CV
Maximum treatment time 30 minutes
Loss or degradation of these functions due to EM disturbances (e.g.
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
When the Primo Interferential 960/Multidyne 970 is turned on, the EMS
company logo is displayed on a splash screen along with the model name
and the software version.
After a few seconds the unit will give a short beep and display the ‘Home’
screen -
Interferential 960 :-
Multidyne 970 :-

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Standard User Controls
Throughout the operation of the unit the various modes and parameter
settings are all accessed and changed by touching the relevant buttons
displayed on the touchscreen.
The rotary control is used to increase and decrease stimulation intensity
when a stimulation screen is selected.
In Interferential 4-pole mode it controls the overall Stimulation intensity, in
all other stimulation modes it is possible to independently control the levels
of channels A and B by touching the appropriate selection button (In the
‘Output’ screen touching both will latch them on to allow simultaneous
control of both channels).
On most display screens touching the ‘back’arrow icon in the top left
corner will return the user to the last screen displayed and touching the
‘House’icon in the top right corner will return the display to the main ‘Home’
screen.
Stimulator set-up
Touching the ‘Interferential’ button on the 960 Home screen will open this
screen –
Touching the ‘Stimulation’ button on the 970 Home screen will open this
screen –

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Scrolling up or down using the ▲ or ▼buttons will reveal more stimulation
options, such as –(Multidyne 970 only)
or –
And finally -

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The first time the stimulator mode is selected from the list after turning on
the unit, or if Interferential 4-pole was previously in use, the selected mode
from the list will be applied to both channels A and B. The stimulator set-up
screen will be displayed, and for any mode other than Interferential 4-pole
the parameters for Channel A will be visible (Ch A is selected at the bottom
left of the screen). To observe and separately edit the parameters (or
mode) for Channel B, touch the ‘B’ button at the bottom left.
System Settings
Touching the ‘System Settings’button at the bottom of the ‘Home’screen
takes you to the ‘System Settings’screen.
The ‘Display’button takes you to a screen where you can adjust the
display brightness using up/down buttons.
The ‘Sound’button takes you to a screen where you can adjust the pitch
and volume of the audio.
‘Language’allows you to change the display language to any that are
installed in the unit (English, French, German, Spanish and Italian as
standard).
The ‘About’button displays info such as serial number and software
version.
‘Help’ brings up an embedded text version of this user manual.
‘Clinic’ allows you to enter a name label for the machine which will be
displayed at the top of all screens.
‘Maintenance’ is designed for service engineers and needs a pass code to
enter.