Chiroform PRIMO COMBINATION 860 User manual

User Manual
PRIMO COMBINATION 860
Model 125

Combination 8602

Combination 860 3
Contents
Page
Contents 3
General information & record of amendments 4
Declaration of conformity to 93/42/EEC 5
Warranty statement 6
Introduction & indications for use 7
Contraindications 9
Accessories 11
Controls and markings 13
Installation 18
Operating instructions 19
Ultrasound 21
Stimulation 27
Combination 44
Protocols 46
Ultrasound dose algorithm 47
Maintenance 49
Appendix A - Overview of treatment modalities 50
Appendix B – Technical specification 56
Appendix C - EMC tables 70
Appendix D – Essential performance 74

Combination 8604
General information
This manual provides the necessary information for the installation and
operation of the Primo Combination 860 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 31/03/11
2 Errata corrected 07/04/11
3 Combination therapy instructions 30/06/11
corrected.
4 Indications for use added 21/06/12
5 Updated to show latest images 08/10/12
6 Declaration of conformity revised 26/06/14

Combination 860 5
EC Declaration of Conformity
Product Name Primo Combination 860
Model Numbers (125) EMS860
EMS Physio Ltd
Grove Technology Park, Downsview Road
Wantage, Oxfordshire, OX12 9FE, United Kingdom
Declares that the device listed above is in conformity with the
essential requirements and provisions of the following EC
Council Directives:
Directive Conformity assessment route
2011/65/EU Annex II, module A (768/2008/EC) (RoHS)
93/42/EEC Annex II of Directive 93/42/EEC under the
supervision of Notified Body Number 0120,
SGS United Kingdom Ltd.
Class IIb according to Annex IX of 93/42/EEC
Signature M Bowles
Position Operations Director
Date 26th June 2014
Date first issued 31st March 2011

Combination 8606
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, electrodes, electrode covers and batteries
are excluded from the above warranty.
It is intended that the Combination 860 unit is only used by qualified
healthcare professionals such as physiotherapists who have received
training in electrotherapy.

Combination 860 7
Introduction
The Primo Combination 860 provides 1 and 3 MHz ultrasound and a
complete range of low and medium frequency waveforms for
electrotherapy. Both modalities may be used individually or in combination.
Indications for use
Therapeutic ultrasound may 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, scar
and excessive fibrous tissue and for pain relief.
Ultrasound may also be used for phonophoresis – the movement of drugs
through the skin under the influence of ultrasound. Some drugs are
absorbed through the skin very slowly and ultrasound may be used to
accelerate the process.
The Primo Combination 860 unit also provides 4 pole and 2 pole
interferential therapy as well as a wide range of other electrical stimulation
waveforms.
Therapeutic voltage and current waveforms may 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, and for pain relief.
Combination therapy involves the simultaneous application of ultrasound
with an electrical stimulation therapy.
By combining ultrasound with interferential therapy, the advantages and
effects of each treatment modality can be realised - but lower intensities
are used to achieve the effect. The accommodation effects that normally
accompany interferential therapy are reduced (or even
eliminated). The main advantages of such a combination are in localising
lesions (especially chronic), in ensuring accurate localisation of ultrasound
treatment to provide increased accuracy / effectiveness in treating deeper
lesions, and in treating trigger points.
Galvanic output may also be used for iontophoresis – the movement of
drugs through the skin under the influence of a steady electrical voltage.
Some drugs are absorbed through the skin very slowly and iontophoresis
may be used to accelerate the process.

Combination 8608
Precautions
The therapist must be aware of the following precautions and potential
hazards.
Simultaneous connection of a patient to high frequency surgical equipment
may result in burns at the site of the stimulator electrodes and possible
damage to the stimulator itself.
Operation in close proximity (less than 1 metre) to shortwave or microwave
therapy equipment may produce instability in the stimulator output.
Consideration must be given to the current densities for any electrode used
with the Combination 860 unit. Current densities greater than 2 mA
rms/cm2are not recommended because of the risk of burning. All the
standard EMS Physio 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 LCD 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.

Combination 860 9
Contraindications - ultrasound
Tumours, as ultrasound affects tissue repair and could therefore
encourage growth.
Infections, due to the risk of spreading the infection.
Pregnancy, treatment over the pregnant uterus as ultrasound could
affect rapidly dividing cells.
Radiotherapy, sites that have received radiotherapy treatment during the
last six months.
Thrombosis and impaired circulation.
Areas of impaired sensation.
Haemorrhage, due to the risk of increased bleeding, including recently
controlled bleeding and haematoma.
Haemophilia.
Implanted devices such as cardiac pacemakers should be avoided due
to the possibility of affecting their operation. Also some plastics
used in replacement surgery may be affected by absorption of ultrasound
energy. Metal implants may lead to reflections, and as a precaution low
doses of ultrasound should be used near these.
Extreme care should be taken when treating areas near the eye because of
the danger of damage to the retina.
Similarly, extreme care should be taken near the ears and reproductive
organs.
Similarly, extreme care should be taken near the ears and reproductive
organs.

Combination 86010
Contraindications - electrotherapy
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 or near the cervical
ganglion.
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, for
example, 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 crosses
the chest.

Combination 860 11
Accessories supplied as standard
Optional accessories
Catalogue
number
Description
SLA9000 DC power supply 18V 60W
PMA9125 Large dual-frequency transducer
EMS502C EMS Physio coupling medium (250ml bottle)
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
EMS530 Primo shoulder bag
EMS158 Primo trolley
PMA9135 Small dual-frequency transducer
EMS502 EMS Physio coupling medium (8 x 250ml bottles)
EMS502A EMS Physio coupling medium 1litre bottle
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

Combination 86012
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)
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. or the agent from whom the
unit was purchased.
EMS P h ysio Ltd.
Grove Technology Park
Downsview Road
Wantage
Oxfordshire OX12 9FE
England
T: 01235 772272
F: 01235 763518
E: [e-mail]
Website: http://www.emsphysio.co.uk

Combination 860 13
Controls and markings
Primo Combination 860 front panel
Ultrasound
output
IEC symbol
878-01-37
Output
Stimulator
output
IEC symbol 348
Attention, consult
accompanying
documents
IEC symbol 7000-1641
Consult instructions for use
IEC symbol
878-02-03 Type
BF equipment

Combination 86014
Primo Combination 860 underside
Description
of
ultrasound
output
waveform
for each
mode
Do not dispose
of as unsorted
waste
(2006/96/EC
WEEE Directive)
Serial
number and
date of
manufacture
Stimulation
output levels
Name and
address of
manufacturer
IEC symbol 348
Attention, consult
accompanying
documents IEC symbol 7000-1641,
consult instructions for
use
Model number
and
classification

Combination 860 15
Primo Combination 860 top
LCD touch
panel
IEC symbol 848-
01-26 variability in
steps
On/Off button
Cradle for
ultrasound
transducer
Output control
knob

Combination 86016
Large transducer
Small transducer
The ultrasound transducers are calibrated independently from the Primo
Combination 860 and are fully interchangeable.
Active
face
Treatment light
Active
face
Treatment light

Combination 860 17
Patient lead (PMA3055)
Electrode connecting
cables
1
2
FOR USE WITH EMS
STIMULATORS
B A
1 2 1 2
TOP
A
B
1
2
1
2

Combination 86018
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.
The Primo Combination 860 must only be used with an EMS Physio
SLA9000 power supply (as supplied with the unit). Units fitted with an
internal rechargeable battery may be used powered by the battery only.
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.
The Primo Combination 860 unit is supplied with a large ultrasound
transducer and four medium-sized electrotherapy electrodes with their
associated patient lead. An optional small transducer is also available.
Plug the ultrasound transducer into the output socket on the front right of
the unit and the patient lead into the one to its left. Each plug has an arrow
and the word ‘top’ embossed on it to aid correct orientation.

Combination 860 19
Operating instructions
Power on sequence and general information
When the Primo Combination 860 is turned on, the EMS company logo is
displayed on the LCD along with the company web address, the model
name and the installed firmware version.
The unit will then give a short beep and display the System Menu screen.
At the bottom of the screen is the status bar.
The status bar shows the current power source and the battery status (if
installed).
If the unit is fitted with a rechargeable battery pack, the battery symbol, ,
will be shown in the status line. The symbol is shaded to show the current
charge state of the battery. indicates a completely discharged battery
and a fully charged battery. The arrow, , to the left of the battery
symbol will be shown if the battery is being charged. To conserve battery
life, the unit will automatically turn off the LCD backlight after 1 minute and
power itself down completely after 3 minutes if there has been no operator
activity and the unit is running off the battery.
1.0?/1.0?
1.0?/1.0?1.0?/1.0?
1.0?/1.0?

Combination 86020
Standard user controls
Throughout the operation of the Combination 860 the various modes and
parameter settings are all accessed and changed by pressing the relevant
display on the LCD touchscreen.
The rotary control is used to increase and decrease the ultrasound intensity
when the LCD is showing the ultrasound screen, or it controls the
stimulation intensity when a stimulation screen is selected.
In 4-pole Interferential 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 pressing and holding the relevant selection button.
In combination mode three buttons are available (except for 4-pole
combination therapy, when there will be two) to select whether the rotary
control is assigned to the ultrasound intensity or channel A or B of the
stimulator.
The menu button is used to exit from the current screen or to select the
menu option highlighted.