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Related Manuals for EMS EMS560
Summary of Contents for EMS EMS560
- Page 1 User Manual EMS560 PRIMO RADIAL SHOCKWAVE Model 135 0120 OM560EN Iss 3...
- Page 2 Primo radial shockwave 560 – OM560EN Iss 3...
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Page 3: Table Of Contents
Contents Page Contents General information & record of amendments Warranty statement Introduction & indications for use Contraindications Accessories Controls and markings Installation Environmental conditions for use and storage Essential performance Operating instructions Shockwave treatment Maintenance Technical specification Appendix A – EMC test levels Appendix B –... -
Page 4: General Information & Record Of Amendments
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... -
Page 5: Warranty Statement
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. -
Page 6: Introduction & Indications For Use
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. -
Page 7: Contraindications
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. - Page 8 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.
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Page 9: Accessories
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. -
Page 10: Controls And Markings
Controls and markings Radial shockwave 560 top TFT display with touchscreen On/off button Base with power supply Primo radial shockwave 560 – OM560EN Iss 3... - Page 11 Primo radial shockwave 560 front label ISO symbol IEC symbol 348 7010-M002, Attention, consult Shockwave consult accompanying applicator instructions for documents output socket Switch input IEC symbol IEC symbol socket 878-02-03 Type 878-01-37 BF equipment Output The output socket is for connection of the shockwave applicator The switch input is for connection of the foot switch Primo radial shockwave 560 –...
- Page 12 Primo radial shockwave 560 underside label ISO symbol 7010- IEC symbol 878- M002, consult 02-03 Type BF instructions for IEC symbol 348 equipment Attention, consult accompanying Name and documents Do not dispose of address of as unsorted manufacturer waste (2006/96/EC WEEE Directive) Serial number Model number...
- Page 13 Primo radial shockwave power supply (EMS559) underside label ISO symbol 7010- IEC symbol 348 M002, consult Attention, consult Do not dispose of Name and instructions for accompanying as unsorted address of documents waste manufacturer (2006/96/EC WEEE Directive) Model number Serial number and date of classification manufacture...
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Page 14: Installation
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. -
Page 15: Environmental Conditions For Use And Storage
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. -
Page 16: 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. - Page 17 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. Treatment counter Main Total energy = (energy per shock) X and progress icon cumulative (number of shocks)/(area of tip)
- Page 18 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 –...
- Page 19 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 ).
- Page 20 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’...
- Page 21 Screen tabs System indicators Footswitch is not pressed - Blank Footswitch Footswitch is pressed indicator pulses are being delivered (blinks with every pulse applied) Trigger indicator No pulses- Blank OK status- Blank System error /warning /failure System (touch the indicator and a pop up message will Status appear) Indicator...
- Page 22 In case of error the ‘X’ indicator appears on the left side of the screen. This indicator appears only when footswitch is pressed, when pulses are being delivered and when System error /warning /failure appears. Touch the indicator and a pop-up message will appear: ‘System error – operation is disabled’.
- Page 23 The Information screen (‘i’ icon) – shows information such as the unit serial number, supplier’s contact details for service and also records and displays the total number of shocks performed by the applicator, the selected tip and the membrane. This is useful for knowing when to replace the tip, membrane cap or applicator element.
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Page 24: Shockwave Treatment
A silicone membrane covers the applicator tip during the treatment and provides close contact between the applicator and the patient’s skin. Do not use membranes or tips other than those supplied by EMS Physio Insert the tip into the applicator and screw tight to secure. Cover the tip with an intact and undamaged membrane*. - Page 25 Make sure that the patient is in a comfortable position for treatment. Locate the treatment area and the most painful point and apply coupling gel to that area. Gently press the applicator tip vertically to the skin. Press the foot switch to start the treatment. During treatment, manoeuvre the applicator around the painful point.
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Page 26: Maintenance
Make sure the applicator ventilation openings are not clogged. In case of any damage call the EMS service department. Cleaning the applicator – At the end of each treatment it is important to clean the applicator and remove any coupling medium. - Page 27 Cleaning the moulded case The unit may be cleaned by wiping over with a damp cloth. Cleaning wipes with alcohol or germicidal solution may be used. It is recommended that the unit be unplugged from the mains before cleaning. The use of abrasive materials and cleaning solvents should be avoided. There are no user serviceable parts inside the unit and it should not be opened.
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Page 28: Technical Specification
Technical specification General Power input (EMS559) 100-240V ac 5A Max.50-60Hz (EMS560) 48V, 9A Max. (from ext. PSU EMS559) Classification (EN60601-1) Class 1, Type BF Fuse In mains inlet, 2 x 5A 250VAC TH Size (h x w x d) 108 x 237 x 333 mm main unit... -
Page 29: Appendix A - Emc Test Levels
Appendix A - EMC test levels. Class/Group/Immunity Test standard Description test level CISPR11:2009+A1:2010 Radiated emissions Class A Group 1 Conducted CISPR11:2009+A1:2010 Class A Group 1 emissions Immunity from IEC/EN 61000-4-2 electrostatic ±15kV air, ±8kV contact discharge Radiated RF IEC/EN 61000-4-3 3V/m immunity Radiated immunity... -
Page 30: Appendix B - Warnings And Error Codes
Appendix B – Warnings and error codes The following is a list of warnings and error message codes that the device may return under certain conditions. They are not all indicative of a serious fault – some are there simply to remind the user that a certain preset limit of number of pulses has been exceeded. - Page 31 Warnings/error messages continued – #1001 – applicator expired Another warning that may appear when the unit is first switched on. The default limit for this is 1,000,000 shocks, at which time it may be advisable to think about ordering a new inner capsule for the applicator. In fact the applicators are capable of up to 2 million shocks so this should be taken more as a warning than an essential action.
- Page 32 M a n u f a c t u r e d b y : EMS Physio Ltd. Grove Technology Park Downsview Road Wantage Oxfordshire OX12 9FE T: 0 1 2 3 5 7 7 2 2 7 2 F : 0 1 2 3 5 7 6 3 5 1 8 E : s a l e s @ e m s p h y s i o .