MULTISTIM MS100 Neuro-muscular Stimulator

Transcription

1 MULTISTIM MS100 Neuro-muscular Stimulator Operating Instructions Metron Medical Australia Pty Ltd ACN P.O. Box 2164, 57 Aster Avenue, Carrum Downs, Victoria, Australia 3201 Int Tel: (613) Int Fax: (613) Tel: (03) Fax: (03) Prepared by: David Mitchell, Metron Medical Australia, Rev 1V6, Mar 2011

2 1 CONTENTS 1 CONTENTS INTRODUCTION OPERATING WARNINGS INDICATIONS FOR USE CONTRAINDICATIONS PRECAUTIONS ELECTROMAGNETIC INTERFERENCE INFLAMMABLE GASES AND ANESTHETICS OPEN WOUNDS OR BROKEN TISSUE PREVENTION OF CROSS INFECTION HANDLING OF PATIENT LEADS DAMAGE TO THE MULTISTIM QUALITY ASSURANCE OPERATIONAL PROCEDURES FRONT PANEL - CONTROLS AND INDICATORS PRACTITIONER UNIT FRONT PANEL - FUNCTIONS OF CONTROLS AND INDICATORS LCD Touch Screen Power On Button Adjust Dial Intensity Dials (Channel A and Channel B) Stop Button Channel Output Indicators (Channel A and Channel B) Channel A Treatment Parameters Channel B Treatment Parameters Protocol (Memory Number and Protocol Name) Modality Carrier Frequency, Pulse Width or Pulse Separation Modulation or Pulse Rate Surging and Continuous Output Start Button Pause Button Treatment Timer Treatment Level (Bargraph and Numeric) SETTING UP THE MULTISTIM USING THE MULTISTIM Selecting a Treatment Protocol Starting Treatment Programs Stopping Treatment Programs Editing or Creating a Treatment Protocol Protocol Name Channel Modality Carrier Frequency and Pulse Parameters Modulation or Pulse Rate Surging and Continuous Output Treatment Timer Store? Creating New Protocols USING THE MULTISTIM THE FIRST TIME MODALITIES SYMBOLS ABBREVIATIONS REAR PANEL...25 Page 2 of 38

3 8.1 MAINS INLET CONNECTOR MAINS FUSES MAINS LABEL EQUIPMENT IDENTIFICATION LABEL CLEANING & PREVENTATIVE MAINTENANCE CLEANING UNIT CLEANING ELECTRODES PREVENTATIVE MAINTENANCE BATTERY REPLACEMENT DECOMMISSIONING AND BATTERY DISPOSAL SPECIFICATIONS WAVEFORMS INTERFERENTIAL (IFC) PREMODULATED INTERFERENTIAL (PREMOD) HIGH VOLTAGE PULSED GALVANIC (HI VOLT) BIPHASIC STIMULATION BIPHASIC BURST STIMULATION RUSSIAN/KOTZ STIMULATION (RUSSIAN) RUSSIAN/KOTZ STIMULATION (RUSSIAN) MICROCURRENT STIMULATION ABOUT US WARRANTY STATEMENT EC DECLARATION CE MARK...36 Page 3 of 38

4 2 INTRODUCTION The Metron Medical MS100 Multistim is a Two Channel Neuromuscular Stimulator intended to be used by medical practitioners, in particular physiotherapists, chiropractors, and physicians. This manual, the MS100 Operating Instructions - describes the operation, precautionary practices as well as information on the care, maintenance and safety. Before administering any treatment to a patient, the user should read, understand and follow the information contained in this manual for each mode of treatment available, as well as the indications, contraindications, warnings and precautions. It is useful to consult other resources for additional information regarding the clinical application of electrotherapy, as developments in this modality are constantly being made. Page 4 of 38

5 3 OPERATING WARNINGS 3.1 Indications For Use The indications for use of this device are: 1. Relaxation of muscle spasm (all waveforms except Microcurrent). 2. Prevention or retardation of disuse atrophy (all waveforms except Microcurrent) 3. Increasing local blood circulation (all waveforms except Microcurrent). 4. Muscle re-education (all waveforms except Microcurrent). 5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis (all waveforms except Microcurrent). 6. Maintaining or increasing range of motion (all waveforms except Microcurrent). Additional Indications for Quadrapolar Interferential, Premodulated Interferential, Microcurrent and TENS waveforms only. 7. Symptomatic relief of chronic intractable pain. 8. Post-traumatic acute pain 9. Post-surgical acute pain. The Multistim should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. 3.2 Contraindications Before the application of the Multistim to a patient for therapeutic purposes the following factors should be duly considered and evaluated: 1. The long term effects of chronic electrical stimulation are unknown. 2. Stimulation should not be applied over the carotid sinus nerves, particularly in patients with a known sensitivity to the carotid sinus reflex. 3. Stimulation should not be applied over the neck or mouth. Severe spasms of the laryngeal and pharyngeal muscles may occur and the contractions may be strong enough to close the airway or cause difficulty in breathing. 4. Stimulation should not be applied transthoracically in that the introduction of electrical current into the heart may cause cardiac arrhythmias. The Multistim should not be used on patients with cardiac demand pacemakers. 5. Stimulation should not be applied transcerebrally. 6. Stimulation should not be applied over swollen, infected, or inflamed areas or skin eruptions, e.g. phlebitis, thrombophlebitis, varicose veins, etc. 7. Stimulation should not be applied over, or in proximity to, cancerous lesions. 8. Any situation where pain syndromes are undiagnosed, until etiology is established. 3.3 Precautions The following precautions should considered and implemented as appropriate: 1. Safety of the use of the Multistim during pregnancy has not been established. 2. Caution should be used for patients with suspected or diagnosed heart problems. 3. Caution should be used for patients with suspected or diagnosed epilepsy. 4. Caution should be used in the presence of the following: a) When there is a tendency to hemorrhage following acute trauma or fracture; b) Following recent surgical procedures when muscle contraction may disrupt the healing process; c) Over the menstruating or pregnant uterus; and d) Over areas of the skin which lack normal sensation. Page 5 of 38

6 5. Some patients may experience skin irritation or hypersensitivity due to electrical stimulation or electrical conductive medium. The irritation can usually be reduced by using an alternative conductive medium, or alternate electrode placement. 6. Electrode placement and stimulation settings should be based on the guidance of the prescribing practitioner. 7. The Multistim should be kept out of the reach of children. 8. The Multistim should be used only with the leads and electrodes recommended for use by the manufacturer. 9. Skin irritations and burns beneath the electrodes have been reported with the use of powered muscle stimulator. 10. Isolated cases of skin irritation may occur at the site of electrode placement following long-term application. 11. Effectiveness is highly dependent upon patient selection by a person qualified in the management of pain patients. 12. Electronic monitoring equipment (such as ECG monitors and ECG alarms) may not operate properly when stimulation is in use. 13. The benefits of electrical stimulation have not been established for pain of central origin. (This includes headache). 14. This device is to be used as a symptomatic treatment for pain and has no curative value. Caution should be taken as the treatment may cause suppression of the sensing of pain which would otherwise serve as a protective mechanism. 15. The Multistim electronics contains charge storage devices, in the event of pausing the treatment and resuming, allow a three second delay for the electronics to discharge before re-commencing treatment. 16. Single use disposable electrodes are to be used only once and used on one patient only. Using the single use disposable electrode more than once will present a hygiene risk to the patient. Used disposable electrodes may not have the proper adhesion properties and could create a risk to the patient as the electrodes contact area will be reduced and possibly lead to excessive current density and burns to the patient. 17. Ensure the Multistim patient leads 2.1 mm plugs are firmly inserted all the way into the electrode receptacles. In the case of the disposable electrodes, there should not be any exposed metal from 2.1 mm plug visible. Any exposed metal from the plug can create a burns risk to the patient, due to accidental touching or unwanted conductive paths in conjunction with perspiration, conductive gel or other conductive liquids. 18. The use of heat packs or 'hot rocks' positioned over patient electrodes is not recommended as this is not the prescribed application method of disposable electrodes. The heat from the heat packs or 'hot rocks' may lead to perspiration build up and the possibility of undesirable conduction paths from the patient leads or electrodes. The undesirable conduction paths can lead to 'hot spots' or high current density which may increase the risk of a patient burn. 3.4 Electromagnetic Interference The Multistim has been designed to comply with IEC : 2002 but this does not guarantee that other equipment in the vicinity will not be affected by the electromagnetic emissions from this unit. Similarly, other equipment in the vicinity may effect the operation of the Multistim. Cell/Mobile Phone Interference and other radiative emissions may effect the sensing of the treatment current by inducing spikes or rapid changes in the measured current. It is important to have Cell/Mobile Phones well away from the Multistim unit when the unit is operating. Other possible sources of spikes may be other instruments or appliances in the clinic (or next room), if the noise is substantial it may be advantageous to move the Patient Sensor to a different location away from the offending noise source. Patient Leads can create problems if they have intermittent breaks in continuity, this can lead to what appears as noise or surge like jumpy currents being felt or displayed on the screen bargraphs, or if the break in continuity is a longer duration it can appear as lead off alarm. This can be avoided by taping the patient leads to the patient so the leads don t pull out of the electrodes or Multistim unit. It is recommended that all equipment used near this unit complies with the relevant electromagnetic compatibility requirements for that equipment and to check before use that no interference is evident or disruptive. Page 6 of 38

7 3.5 Inflammable Gases and Anesthetics The Multistim is NOT SUITABLE for use in the presence of inflammable gases and anesthetics. 3.6 Open Wounds or Broken Tissue The Multistim adhesive electrodes and carbon rubber/sponge electrodes have not been designed to be used on open wounds or broken skin. Use in the presence of these conditions is not recommended and is not an intended use of the device. 3.7 Prevention of Cross Infection The Multistim is designed to be used with one time use disposable adhesive patches. These disposable adhesive patches are not designed for repeated usage, nor are they designed for use between patients as this may lead to patient cross infection as the patches contact the skin surface. 3.8 Handling of Patient Leads The Patient leads may be compromised by rough handling, dropping or by stepping on top of. Handling of the cable in these ways may adversely affect the performance of the Multistim system. Careful handling of the Patient Lead will prolong the leads life and preserve its electrical and mechanical characteristics. The patient is connected to the machine for treatment via the patient-circuit output sockets located on the front of the unit. Two pairs of output sockets are available, Channel A pair and Channel B pair. Each pair has a RED (+) socket and a BLACK (-) socket, the RED socket indicates the positive terminal for stimuli which is polarity specific - i.e. Monophasic type waveforms and Direct Current type outputs. When pushing the Patient Lead Plug into or out of the Multistim sockets use care and hold firmly the RED or BLACK plastic part of the plug, pulling the plugs out by using the cable will reduce the lifetime of the leads and may cause wires to break inside the cable. Standard electrode configurations (quadripolar or bipolar) can be connected to these sockets using the patient cables and carbonflex electrodes supplied. 3.9 Damage to the Multistim If when the unit is unpacked, or if it is mishandled at any stage of its life, and there appears to be physical damage to the machine, it should not be used. Use should only commence or continue after it has been thoroughly checked by an appropriately qualified technician to ensure its functional and safety performance has not been impaired. Page 7 of 38

8 3.10 Quality Assurance It is recommended that a program of regular and appropriate quality assurance including verification/calibration and electrical safety inspections be instituted for this equipment. Calibration should be performed at 12 month intervals. Information on the type and frequency of electrical safety testing may be obtained from locally published Standards. In Australia, the relevant Standards published by the Standards Australia are: AS 2500 EN AS 3551 (1986) - Guide to the Safe Use of Electricity in Patient Care (1998) Approval and Test Specification Medical Electrical Equipment Part 1: General Requirements (1988) - Acceptance Testing and In-Service Testing, Electromedical Equipment A hospital Biomedical Engineering Department or a third party service organization nominated by the manufacturer or distributor should be capable of performing the necessary calibration, testing and documentation. A program of electrical safety inspections is recommended to confirm continued operator and patient safety. Local statutory requirements for electrical safety inspections may also apply. Notes about the device: 1) Practitioner Unit is a Class I Electrical Device - 3 Pin mains connection (Active, Neutral and Ground). 2) Both the Screws fastening the IEC socket to the Practitioner Unit enclosure are grounded and can be used as accessible metal parts for testing ground continuity. 3) The Multistim System is a Class IIa Medical Device as defined by the MDD 93/42/EEC. 4) The Multistim System is a Class IIa Medical Device as defined by the TGA's Therapeutic Goods Medical Device Regulations (2002). 5) The Multistim System is a Class II Medical Device as defined by Health Canada. 6) The Multistim has MOV's (Metal Oxide Varistors) across the mains connection IEC socket, test voltages need to be below 250V. 7) The Multistim does not have a filtered mains IEC socket. 8) The Multistim has no equipotential earth connection. Page 8 of 38

9 4 OPERATIONAL PROCEDURES 4.1 Front Panel - Controls and Indicators Controls and displays located on the top panel: 1. LCD Touch Screen 6. Channel B Output Status (White) 2. Channel A Intensity Dial 7. Channel B Intensity Dial 3. Channel A Output Status (Blue) 8. Power On Button 4. Emergency Stop Button 5. Parameter Adjustment Dial Page 9 of 38

10 4.2 Practitioner Unit Front Panel - Functions of Controls and Indicators LCD Touch Screen The LCD Touch Screen is the major feature on the front panel of the Multistim. The LCD is divided down the middle to display the treatment parameters of the two stimulation channels - Channel A (on the left-hand side) and Channel B (on the right-hand side). The LCD has a touch sensitive layer on top, which enables the practitioner to select and adjust parameters and to start and pause treatment. A guide on how to select and adjust parameters is described later in another section of this manual Power On Button The mains power cord should be connected to mains power outlet and the outlet turned on. To switch the unit On, press the 'Power' Button, the LCD display backlight will illuminate indicating the unit is ready for use. Also the unit can be switched Off by pressing the 'Power' Button. To completely isolate the Multistim Practitioner Unit from the mains supply the detachable power cord must be removed from the socket located on the rear panel. This would be necessary for example to open the enclosure to perform service work Adjust Dial The 'Adjust' dial is located in the centre of the front panel, it is a rotary control used in conjunction with the Touch screen. Once a selection has been made by the Touch Screen the 'Adjust' Dial can be used to (a) Change a Treatment Protocol (b) Increase or Decrease a treatment parameters numerical value (c) Change the Treatment Modality or (d) Scroll through the Alphabet when changing a Treatment Protocol Name. Rotating the Dial Clockwise increases a value, or by rotating the Dial Counterclockwise decreases a value. The 'Adjust' Dial is indented, so when rotating the Dial one can feel these small indentations, these are tactile feedback that indicate a parameter or value has changed by one step Intensity Dials (Channel A and Channel B) The 'Intensity' dials are located on both the left and right-hand side of the front panel under the LCD. The 'Intensity' Dial performs only one function, that is to change the Output Level of the electrical stimulation for that side - i.e. either Channel A for the left hand side dial and Channel B for the right hand side. As the LCD is divided down the middle so the dials are spatially aligned with the treatment parameters above them. Rotating the Dial Clockwise increases the output level, or by rotating the Dial Counterclockwise decreases the output level. The 'Intensity' Dial is indented, so when rotating the Dial one can feel small 'bumps', the small 'bumps' are a tactile feedback that indicate output level is being changed. Page 10 of 38

11 4.2.5 Stop Button The 'Stop' Button is located on the lower centre of the front panel, the button has a tactile 'click' feel when pressed. The 'Stop' Button immediately terminates the stimulation output on both channels. The 'Stop' Button is intended to be used by the Practitioner or Patient to stop the treatment in the event of patient discomfort from the electrical stimulation Channel Output Indicators (Channel A and Channel B) The Channel Output Indicators are two slotted windows at the bottom of the panel, each window has two LED's positioned behind the tint. The Channel A (labeled 'ch A') uses two blue LED's to indicate the Channel is active and Channel B (labeled 'ch B') uses two white LED's to indicate the Channel is active Channel A Treatment Parameters The Channel A Parameters are listed vertically on the left-hand side of the LCD. To be spatially congruent the Intensity control for Channel A is also located on the left-hand side - under these parameters. Channel A and Channel B are independent, each channel can be have the same or a different Treatment Protocol active, the Protocols can be Started or Paused independently of each other, and have the intensity controlled independently. The only exception is Quadra/Tetrapolar Interferential (4 pole), where Channel A selects this modality and effectively takes over the Channel B Treatment Parameter screen (only if Channel B inactive) Channel B Treatment Parameters The Channel B Parameters are listed vertically on the right-hand side of the LCD. To be spatially congruent the Intensity control for Channel B is also located on the right-hand side - under these parameters. Channel B operates normally as Channel A does except for one modality - Quadra-polar Interferential, in this mode the key parameters are listed on Channel A, and the treatment current is controlled with the Channel A intensity dial (ie both Channels are step-locked together), however the Channel B intensity dial can be used to make small adjustments to the Channel B current level in order to balance the current levels of both Channel A and Channel B. Page 11 of 38

12 4.2.9 Protocol (Memory Number and Protocol Name) The 'Protocol' button for each channel is the first button on either side of the LCD screen. The number is the memory slot number, of which there are 50 memory slots available. Next is the Protocol Name, which is to aid usage. The Protocol Name can be modified for any Memory Number Modality Under the Protocol button is the Modality button. There are 10 possible selections for the Modality, these are: 1. PREMOD - Premodulated Interferential Current (2 Pole Interferential) 2. PREMOD FIXED Premodulated Interferential Current, fixed beat frequency (adjustable). 3. I F C - Quadrapolar Interferential Current (4 Pole Interferential) 4. I F C FIXED Quadrapolar Interferential Current, fixed beat frequency (adjustable) 5. RUSSIAN - Russian Current according to Kotz - 2 khz AC Current Modulated at 50 Hz 6. HI VOLT - High Voltage Pulsed Galvanic - Two Monophasic Exponential Pulses 7. HI VOLT ALT - High Voltage Pulsed Galvanic with Alternating Polarity Pulses 8. BIPHASIC - Transcutaneous Electrical Nerve Stimulation - Repetitive Biphasic Pulses 9. BIPHASIC Burst - Transcutaneous Electrical Nerve Stimulation - Repetitive Series of Biphasic Pulses 10. MICROCURRENT - Microcurrent - Low Amplitude Monophasic Pulses Carrier Frequency, Pulse Width or Pulse Separation Beneath Modality is the Carrier Frequency (or Pulse Width or Pulse Separation) parameter. The parameter is dependant on which Modality is selected. For example when the Modality is PREMOD the Carrier Frequency can be 4 khz, 5 khz, 8 khz and 10 khz but when BIPHASIC is selected as the Modality, the parameter (now Pulse Width) is variable between 20 us to 410 us (adjustable in 10 us steps). And for HI VOLT the parameter is Pulse separation is variable between 25 to 75 us in 5 us steps. Page 12 of 38

13 Modulation or Pulse Rate Under the Carrier button is the Modulation button (or depending on the Modality, the Pulse Rate). Modulation Selection: 1 to 10 Hz Sweep 80 to 150 Hz Sweep 1 to 150 Hz Sweep 1 to 250 Hz Sweep 10 to 250 Hz Sweep 10 to 25 Hz Sweep 25 to 80 Hz Sweep Rate Selection: 1 to 250 Hz Surging and Continuous Output Under the Modulation button is the Surge button. Surge Selection: Cont. i.e.: no surging 5/5 s i.e.: 5 seconds on & 5 seconds off* 4/12 s 10/10 s 10/20 s 10/30 s 10/50 s * excluding ramp up and ramp down times (~ 2 to 3 seconds) for all surge selections Start Button The 'Start button (Bolded Border) is the sixth button on the Touch screen LCD. If the button is touched (a confirmation beep will be heard) the treatment will started with the parameters displayed on the screen - i.e. the timer will start running and the channel output will be active and a highlighted Pause Button graphic will replace the Start button graphic on the LCD screen. The Start button occasionally will not have the "START" wording but instead the wording "NOT AVAILABLE", this indicates that the selected modality is currently unavailable - for example if Channel A is active and treating a patient with BIPHASIC, Channel B will indicate that IFC is "NOT AVAILABLE" as this modality requires both channels to operate. Page 13 of 38

14 Pause Button When the Start button is touched the channel output becomes active and the highlighted Pause button graphic will be displayed. The Pause button is highlighted so that it is easily visible, The treatment parameters are not changeable once treatment has started. when desired, and parameters can be changed. When the Pause button is touched the timer will be paused, the output will be ramped down to zero, the output circuits will be switched off and stopped, and the Start button graphic replaces the Pause button graphic so that therapy can be re-started Treatment Timer Under the Start button is the treatment Timer button with the minutes and seconds following. The treatment timer can be is set in increments of minutes. also stop. The treatment timer will countdown when the channel output is active, as the treatment continues the treatment timer shows the amount of time still left for the treatment to complete. When the channel is paused the treatment timer will stop, or if the 'Stop' button is pressed the treatment timer will Treatment Level (Bargraph and Numeric) The Treatment level bargraph and numeric display are visible when the treatment is started. Located at the bottom of the LCD touch screen is the bargraph which shows qualitatively the treatment current (or voltage in some cases), above this bargraph is a numerical value of the current or voltage (with relevant SI units). Also positioned in this section is the Patient Lead Indicator - which is a small graphic symbol next to the wording "Lead". The Lead Indicator shows the electrical continuity status of the three external elements : patient leads - electrodes - patient skin. The indicator has a minimum threshold of several milliamps or about ¾ of a dial rotation before the system becomes active. The Lead indicator also has an audio alarm to indicate a high resistance or lead off condition. 4.3 SETTING UP THE MULTISTIM Connection to mains: The mains power cord should be connected to the IEC power socket at the rear of the Unit. The other end of the power cord should then be plugged into the mains power outlet, and the power outlet switched on. Page 14 of 38

15 Power Up: On the Multistim front panel on the right hand side there is a button labeled 'power'. The 'power' button is pressed for about half a second. The Multistim will make a two tone beep, the screen will light up and display the Metron logo for several seconds and then display the treatment parameters. Patient Leads: Connect the Patient Leads to the Multistim. The Multistim has four 4mm sockets at the front of the unit, the sockets are grouped into two pairs each color coded for polarity Red (+) and Black (-). Connect each Red and Black socket to the matching Red and Black plugs on the Patient lead - this is illustrated below. Patient Electrodes: There are a variety of patient electrodes available for electrical stimulation, generally the electrodes will be either disposable adhesive electrodes or carbon flex/sponge pocket type electrodes. The Patient Leads have 2.1 mm plugs (pins) which can be connected to the small lead on the disposable electrodes or plug directly into the rubberized carbon flex electrode. 4.4 USING THE MULTISTIM Selecting a Treatment Protocol When the Multistim is switched on by pressing the Power button, the Multistim will display the last protocol(s) previously used on the screen. To select a protocol touch the Protocol button at the top part of the screen. Page 15 of 38

16 The Protocol button will now be highlighted (and a confirmation beep), indicating the protocol can be changed to another. Slowly rotate the Adjust Dial (the central bigger dial) to change to the desired protocol. As the Dial is rotated, the screen will show the new program number, the protocol name and all the new parameters associated with the protocol. Rotating the Adjust Dial clockwise scrolls through the program numbers incrementally, and rotating counter-clockwise scrolls in reverse order. Page 16 of 38

17 4.4.2 Starting Treatment Programs Once the desired protocol has been selected, to commence treatment the START button is touched. When the START button is touched an audible beep will be heard and the START button will be highlighted and START text will change to PAUSE. The treatment parameters cant be adjusted once the treatment has been started. The Intensity dial can be rotated to increase or decrease the output level. Page 17 of 38

18 As the Intensity dial is rotated the output level is shown on the bargraph below along with the numeric value. Always adjust the output level slowly for patient comfort and response time. When the output is active two LED's will light up in the lower section of the front panel, above the patient leads. These can be seen from some distance away to confirm treatment is in operation Stopping Treatment Programs Although the treatment timer will shut-off treatment once the treatment time has elapsed. To Stop and Pause the program, simply touch the PAUSE button at any time. Page 18 of 38

19 When the PAUSE button is touched a long high-pitched beep will be heard and the PAUSE button will go to un-highlighted state and the PAUSE text will change to START. The channel will go inactive and the stimulation output will be switched off and the output level will be zero milliamps or zero volts. When the output is inactive the two LED's will turn off in the lower section of the front panel, above the patient leads Editing or Creating a Treatment Protocol Protocol Name 1) To change the Protocol Name, simply touch the Protocol button once to select the Protocol button (the button will be highlighted). 2) Touch the Protocol button a second time to enter Edit mode (the first character will be selected shown by a). Once in Edit Mode rotating the Adjust Dial will scroll through the Alphabet and Numbers for each character. To move to the next Character touch the > arrow in the EDIT button below, to move back to a previous Letter touch the < arrow in the EDIT button below. 3) To save the new Name or any other modified parameter, touch the word store? that appears at the top of the screen. To exit editing the Name without saving the new Name, don t touch the store button. Page 19 of 38

20 Channel Modality To change or select a Modality, touch the Modality button (for example the words PREMOD), when the Modality is touched the button will be highlighted - enabling the Modality to be changed. Rotating the Adjust Dial will scroll through the available Modalities. The Modalities list will scroll over at the end of the list. The Modality list for the MS-100 is: 1. I F C - Quadrapolar Interferential Current (4 Pole Interferential) 2. I F C FIXED Quadrapolar Interferential Current, fixed beat frequency (adjustable) 3. PREMOD - Premodulated Interferential Current (2 Pole Interferential) 4. PREMOD FIXED Premodulated Interferential Current, fixed beat frequency (adjustable). 5. RUSSIAN - Russian Current according to Kotz - 2 khz AC Current Modulated at 50 Hz 6. HI VOLT - High Voltage Pulsed Galvanic - Two Monophasic Exponential Pulses 7. HI VOLT ALT - High Voltage Pulsed Galvanic with Alternating Polarity Pulses 8. BIPHASIC - Transcutaneous Electrical Nerve Stimulation - Repetitive Biphasic Pulses 9. BIPHASIC Burst - Transcutaneous Electrical Nerve Stimulation - Repetitive Series of Biphasic Pulses 10. MICROCURRENT - Microcurrent - Low Amplitude Monophasic Pulses Carrier Frequency and Pulse Parameters To select the Carrier Frequency (or Pulse Parameters), touch the Value displayed on the screen, when the Value is touched the Value will be highlighted - enabling the Value to be changed. Rotating the Adjust Dial will index (either + or - steps) through the available values. IFC & PREMOD (& FIXED) the Carrier Frequency can be 4 khz, 5 khz and 10 khz. RUSSIAN the Carrier Frequency can be 2 khz and 2.5 khz. HI VOLT (& Alt.) the Pulse Separation can be 15 to 65 us in 5 us Steps. BIPHASIC (& Burst) the Pulse Width can be 20 to 410 us in 10 us Steps. MICROCURRENT the Duty Cycle value 50% or 25% Modulation or Pulse Rate To select the Modulation or Repetition Rate touch the Modulation/Rate Value displayed on the screen, when the Value is touched the Value will be highlighted - enabling the Value to be changed. Rotating the Adjust Dial will index (either + or - steps) through the available values. For PREMOD and I F C Modulation Selections: 1 to 10 Hz Sweep 80 to 150 Hz Sweep 1 to 150 Hz Sweep 1 to 250 Hz Sweep 10 to 250 Hz Sweep 10 to 25 Hz Sweep 25 to 80 Hz Sweep BIPHASIC, BIPHASIC Burst, HI VOLT, HI VOLT Alt, MICROCURRENT, RUSSIAN and PREMOD & IFC FIXED Rate Selection: 1 to 250 Hz * Note RUSSIAN, PREMOD FIXED at low rates (1 to 10 Hz) will cause the display Page 20 of 38

21 Surging and Continuous Output To select the Modulation or Repetition Rate touch the Modulation/Rate Value displayed on the screen, when the Value is touched the Value will be highlighted - enabling the Value to be changed. Rotating the Adjust Dial will index (either + or - steps) through the available values. Surge Selection: Cont. ie: Continuous no surging, direct output. 5/5 s ie: 5 seconds on & 5 seconds off* 4/12 s 10/10 s 10/20 s 10/30 s 10/50 s * excluding ramping up and down times (~ 2 to 3 seconds) for all surge selections Treatment Timer To select the Treatment Time, touch the TIMER button, the Timer Value will be highlighted - enabling the Timer Value to be changed. Rotating the Adjust Dial will index the time forward and back in 1 Minute intervals Store? When any parameter is changed, the word STORE? appears at the top of the screen. This tells the practitioner that a parameter value in the Program/Protocol has been changed, touching the highlighted word STORE? will store this changed parameter value to the current Program memory. If STORE? is not touched and the Treatment is started by pressing the START button, the new changed parameter will be used in the treatment, but not stored to Program memory Creating New Protocols New Protocols can be created by modifying and overwriting the preset protocols (Program Memories 1 to 20) or by modifying and overwriting the blank programs (Program Memories 21 to 50). When creating a new protocol the first parameter to be modified should be the modality (the Mode), as different modalities will have a different selection of parameters which may or may not be changeable. Changing the parameters first and then changing the Modality will lead to the parameters be cleared to default settings. 4.5 USING THE MULTISTIM THE FIRST TIME Before using the Multistim on a patient for the first time, it is advisable to confirm the Multistim is operating normally. The following checklist can be followed to confirm the correct operation of the displays and controls. 1. Press the 'Power Button' the Multistim will power up, make a beep sound and illuminate the LCD backlight and display an initialization message with "Metron", "Multistim MS-100" and a software version number on the screen. 2. A few seconds later the screen will display both channels. 3. Connect the Patient Leads to the Multistim. The Multistim has four 4mm sockets at the front of the unit, the sockets are grouped into two pairs each color coded for polarity Red (+) and Black (-). Connect each Red and Black socket to the matching Red and Black plugs on the Patient lead. Page 21 of 38

22 4. The Patient Leads have 2.1 mm plugs (pins) which can connect to the small lead on the disposable electrodes or plug directly into the rubberized carbon flex electrode. 5. Apply the electrodes to the arm or leg, which ever is more comfortable to the practitioner. 6. Select a Program to test, for instance a program #1 SPASM MM utilizing PREMOD and Cont. (no surging) is a good initial choice. Note: Microcurrents lack of sensation usually makes it an unsuitable for a first use test modality. 7. Start the Program, by touching the START BUTTON. 8. Adjust the Intensity level using the associated Intensity Dial, adjust the intensity until a tingling sensation is just felt, then adjust the intensity dial down to zero. 9. Stop the Program, by touching the PAUSE BUTTON. 10. Repeat steps 6 to 8 for the other Channel. 11. Remove the electrodes from the arm or leg. 12. Remove the electrodes from the Patient Leads. 13. Remove the Patient Leads from the Multistim front panel. 14. Press the 'Power Button' the Multistim will power down and the LCD backlight will go dark. 15. If both channels producing the normal tingling sensations of electrotherapy, then the Multistim is operating normally and can be used clinically. 5 Modalities IFC & IFC FIXED - Quadrapolar Interferential Current The IFC Modality is a special case for the Multistim as it uses both Channel A and Channel B simultaneously (four pole), whereas all the other modalities use only one channel (two pole). IFC Mode is selected by using a Channel A program with IFC as the modality (provided Channel B is not active) the whole screen will display the IHC parameters and the international Quadrapolar symbol. The IFC parameters are Carrier Frequency (4 khz, 5 khz and 10 khz), FIXED Beat frequency from 1 Hz to 250 Hz and Beat frequency sweeps in the range 1 Hz to 250 Hz, Continuous output and Surge times from 5/5 to 10/50 seconds. The Treatment Timer can be set from a range of 1 minute to a maximum of 60 minutes. The Channel A intensity controls the current for both Channels in lock step, if for some reason the current in each channel is not equal - for example electrode placement or variations in tissue impedance, the currents can be equalized by adjusting the intensity dial on the Channel B side (Right) to balance the currents. Interferential Current is generated by AC waveforms so there is no special consideration to the connection of the Red and Black patient leads connecting to the patient electrodes. The Electrodes should be positioned in diagonally opposite pairs so that the currents intersect in the region to be treated. PREMOD & PREMOD FIXED - Premodulated Interferential Current The Premodulated Modality for the Multistim can be used on either Channel A or Channel B or even both Channels. When both channels have Premodulated selected, it is possible to treat two patients at the same time or have both Premodulated channels treating the one patient, it is the practitioners discretion on the best treatment. The Premodulated parameters are Carrier Frequency (4 khz, 5 khz and 10 khz), FIXED Beat frequency from 1 Hz to 250 Hz and Beat frequency sweeps in the range 1 Hz to 250 Hz. Continuous output and Page 22 of 38

23 Surge times from 5/5 to 10/50 seconds. The Treatment Timer can be set from a range of 1 minute to a maximum of 60 minutes. The output current level is controlled from the selected channel's Intensity control. Premodulated Interferential Current is generated by an AC waveform so there is no special consideration to the connection of the Red and Black patient leads connecting to the patient electrodes. RUSSIAN - Russian Current according to Kotz The Russian Modality for the Multistim can be used on either Channel A or Channel B or even both Channels. When both channels have Russian selected, it is possible to treat two patients at the same time or have both Premodulated channels treating the one patient, it is the practitioners discretion on the best treatment. The Russian parameters are Carrier Frequency (2 khz, 2.5 khz), Beat frequency default setting is 50 Hz but can be edited from 1 Hz to 250 Hz, Continuous output and Surge times from 5/5 to 10/50 seconds. The Treatment Timer can be set from a range of 1 minute to a maximum of 60 minutes. The output current level is controlled from the selected channel's Intensity control. Russian Current is generated by an AC waveform so there is no special consideration to the connection of the Red and Black patient leads connecting to the patient electrodes. BIPHASIC and BIPHASIC Burst - Transcutaneous Electrical Nerve Stimulation The BIPHASIC Modality for the Multistim can be used on either Channel A or Channel B or even both Channels. When both channels have BIPHASIC selected, it is possible to treat two patients at the same time or have both BIPHASIC channels treating the one patient, it is the practitioners discretion on the best treatment. The BIPHASIC parameters are Pulse Width (30 us to 410 us in 10 us steps), Pulse Repetition Rates from 1 Hz to 250 Hz, Continuous output or Surge Rise and Fall Times from 5/5 to 10/50 seconds. The Treatment Timer can be set from a range of 1 minute to a maximum of 60 minutes. In the TENS Burst mode the number of pulses is fixed to 4 pulse per repetition. The output current level is controlled from the selected channel's Intensity control. The TENS Current is a symmetrical biphasic waveform so there is no special consideration to the connection of the Red and Black patient leads connecting to the patient electrodes. HI VOLT and HI VOLT ALT - High Voltage Pulse Galvanic The HI VOLT Modality for the Multistim can be used on either Channel A or Channel B or even both Channels. When both channels have HV Galvanic selected, it is possible to treat two patients at the same time or have both HV Galvanic channels treating the one patient, it is the practitioners discretion on the best treatment. The HV Galvanic parameters are Pulse Separation (30 us to 65 us in 5 us steps), Repetition Rates from 1 Hz to 250 Hz, Continuous output or Surge Rise and Fall Times from 5/5 to 10/50 seconds. The Treatment Timer can be set from a range of 1 minute to a maximum of 60 minutes. The output current level is controlled from the selected channel's Intensity control. The High Voltage Pulsed Galvanic Current is a dual Monophasic pulsed (exp. pulse width 7us) waveform so special consideration must be given to the connection of the Red and Black patient leads connecting to the patient electrodes. For the case of HI VOLT. ALT which is a High Voltage Pulsed Galvanic waveform that alternates its polarity in synchronism with the Surge cycle, there is no special consideration as to the connection polarity of the Red and Black patient leads connecting to the patient electrodes. MICROCURRENT The Microcurrent Modality for the Multistim can be used on either Channel A or Channel B or even both Channels. When both channels have Microcurrent selected, it is possible to treat two patients at the same time or have both Microcurrent channels treating the one patient, it is the practitioners discretion on the best treatment. Page 23 of 38

24 The Microcurrent parameters are Frequency from 1 Hz to 250 Hz). The Treatment Timer can be set from a range of 1 minute to a maximum of 60 minutes. The output current level is controlled from the selected channel's Intensity control up to a maximum of 750 ua. The Microcurrent is a monophasic pulsed waveform so special consideration must be given to the connection of the Red and Black patient leads connecting to the patient electrodes. Electrode Considerations The Multistim is provided with a set of four conductive rubber electrodes (and sponge pockets) and Two pairs of single use disposable adhesive electrodes. The single use disposable electrodes can be used with all the Multistim modalities. Current spreads within the tissue and that the area of maximum stimulation will depend on the electrode arrangement and the particular modality being used. The electrode size required depends on the area to be treated. Small electrodes would be selected for treatment of, for example, the elbow or ankle joints. Large electrodes are more appropriate for areas such as the low back or quadriceps. For Quadrapolar Interferential (IFC) the electrodes should be positioned in diagonally opposite pairs so that the currents intersect in the region to be treated. Electrodes (3 or 7 cm Diameter) supplied with the Multistim are safe to use at all current levels but consideration of current and power density for that electrode should be undertaken prior to use. The maximum power density recommended is 0.25 watts/square cm (W/cm 2 ) of electrode area, or another measures is 2mA rms per square cm. If the worst case patient impedance, for power transfer, is assumed then for a round electrode the maximum current that should be used, in milliamps, is approximately given by the following equation: I max = 14 x Electrode Diameter in cm All electrodes supplied with this unit are safe to operate over the output current range provided by the Multistim. Normal electrode application procedures should always be practised. When treating patients, particularly at higher current levels, practitioners should be aware of the problems associated with electrode use and respond to any indication that may suggest an electrode problem. The use of nonstandard electrodes requires consideration of current and power density issues. 6 Symbols Several symbols are used on the enclosure of the Multistim which are defined as follows: On/Off (standby) button: Pressing the On/Off button switches the device on or conversely off. + - Increase Parameter Symbol: The Adjust Dial when rotated Clock Wise increases the selected parameters value. Decrease Parameter Symbol: The Adjust Dial when rotated Counter Clock Wise increases the selected parameters value. Variability in Steps Symbol: The Intensity Dials when rotated increase or decrease the output in discrete steps. Attention Symbol: indicates that the instructions for use should be consulted before operation is attempted. BF Symbol: indicates that the applied parts (electrodes) of this equipment are rated as Type BF which means that the applied parts are suitable for placement on the external surface of the body. Page 24 of 38

25 Fuse rating symbol: indicates the fuse is located adjacent to symbol and to be replaced with a fuse of the stated rating WEEE symbol: indicates the device should not be disposed in municipal waste, but in an environmentally responsible way (see 8.4) 0805 CE Mark 7 Abbreviations LED - Light Emitting Diode LCD - Liquid Crystal Display Nr. - Number SN - Serial Number W - Watts V - Volts cm - Centimeter A - Amperes ma - Milliamperes ua - Microamperes W/cm2 - Watts per centimeter squared CE - Conformity European - the CE mark WEEE - Waste Electrical and Electronic Equipment BF - Body Floating - medical electrical classification 8 Rear Panel Equipment Identification Label Mains Label Fuse Drawer Mains Inlet Connector 8.1 Mains Inlet Connector The mains inlet connector is an IEC appliance connection and contains the mains power connector and fuse holder. The mains cable supplied with the Multistim should be fitted with an approved plug suitable Page 25 of 38

26 for connection to local mains power outlets. Ensure that the mains power outlet is properly earthed. IMPORTANT: It is important that the Multistim be operated from a mains supply which has a nominal supply voltage equal to that indicated on the mains label on the rear panel. Safety and performance specifications are only valid if these voltages are the same. 8.2 Mains Fuses External mains fuses are installed to protect the Multistim from damage if certain internal faults occur. Fuses do age and sometimes fail unnecessarily. Fuse failure should not, however, be interpreted as a fault in the fuse only. If the mains fuses fail, the Multistim should be inspected by a qualified technician. Ensure that mains fuses are replaced with the same type and rating as stated on the mains power label. 8.3 Mains Label This label is located on the back of the unit and provides information on the voltage ratings, frequency, power and the fuse ratings. 8.4 Equipment Identification Label This label is located on the underside of the unit and provides information on the manufacturer, equipment identification and details of the input range. 9 Cleaning & Preventative Maintenance 9.1 Cleaning Unit There is no requirement for routine cleaning of the Multistim other than to ensure that all ventilation holes are kept clear of debris and any spillage of conductive gels, etc, particularly on the front of the unit and near the mains inlet connector on the back of the unit be removed as soon as possible. If cleaning is necessary a damp cloth soaked in a mixture of mild soap and water is recommended. Page 26 of 38

27 9.2 Cleaning Electrodes The carbonflex electrodes and sponge pouches supplied with the Multistim should be regularly cleaned to prevent any build up of conductive mediums and general contaminates which accumulate as a consequence of normal use. The electrodes can be readily cleaned by regular washing in a solution of water and mild soap. The frequency of cleaning will depend upon usage patterns and what type of conductive medium is used. Visual inspection is the best method of determining when cleaning is required. If vacuum electrodes are used with the Multistim they should be cleaned in accordance with the instructions accompanying the vacuum unit. Between patient treatments sponges should be briefly rinsed in an antibacterial solution such as "Milton" at a recommended strength of 25 ml per 2 litres of water. The sponges should not be left in "Milton" solution for long periods of time as this could shorten the life of the sponge. Do not soak sponges in alcohol solutions as these inhibit electrical conductivity. The suction sponges may be rinsed in a weak saline/salt solution before connection to the patient in order to increase the conductivity between electrode and patient. The recommended strength is 5 grams per 4 litres of water (approx.). 1 teaspoon per gallon of water). Care must be taken when using saline solutions as they can become corrosive and leave heavy deposits through the vacuum system, blocking hoses and reducing the life of both mechanical and electronic components. Single use Disposable Electrodes are not to be cleaned. Single use disposable electrodes are to be used only once and used on one patient only. Using the single use disposable electrode more than once will present a hygiene risk to the patient. Used disposable electrodes may not have the proper adhesion properties and could create a risk to the patient as the electrodes contact area will be reduced and possibly lead to excessive current density and burns to the patient. 9.3 Preventative Maintenance There is no preventative maintenance that needs to be performed on the Multistim other than occasional cleaning as detailed above. It is however recommended that routine calibration verification and electrical safety testing be carried out on the Multistim at least once every twelve months. Information on the type and frequency of electrical safety testing may be obtained from Australian Standard AS 3551 or from relevant locally published US standards. 9.4 Battery Replacement The Multistim MS100 does not contain any batteries, so no special battery replacement procedures are required. 9.5 Decommissioning and Battery Disposal The Multistim MS100 does not contains any batteries, so no special battery removal or disposal procedures are required for decommissioning or disposal. WEEE symbol: The symbol of the doubled crossed wheelie bin shown below indicates the device should not be disposed of in unsorted municipal waste, but in an environmentally responsible way. Page 27 of 38

28 10 SPECIFICATIONS MAINS SUPPLY REQUIREMENTS: Voltage Frequency Secondary Voltage Secondary Current Volts AC 50/60 Hz 48 Volts DC 1.7 A OUTPUTS: System Output Accuracies: Output Current Indicators Output Voltage Indicators Frequency Better than +/- 5% Pulse Timing Characteristics Better than +/- 5% Timer and Timing Better than +/- 5% +/- 20% for currents greater than 10 ma +/- 20% for voltages greater than 50 V (Load impedance 1000 ohms) IFC and PREMOD: Maximum current in each patient circuit: Maximum voltage in each patient circuit: Current waveform type: Carrier frequency selection: Beat frequency range: Beat frequency: Output mode: Output configuration: 0 to 80 ma Average 160 V Peak to Peak Rectangular Biphasic AC 4 khz, 5 khz or 10 khz Variable from 1 Hz to 250 Hz Sweep or Fixed Frequency Surged or Continuous IFC (4 pole) Interferential or Premod (2 pole) Interferential HI VOLT: Maximum voltage in each patient circuit: 0 to 150 V peak into 1 k ohm load Stimulus application: Monopolar Current waveform type: Twin Spike Pulses, each 7 µs FWHM Spike separation selection: 75 µs or 25 µs Pulse frequency range: Variable from 1 Hz to 250 Hz Pulse frequency: Fixed Frequency Output mode: Surged or Continuous Output configuration: Positive Polarity or Alternating Polarity mode BIPHASIC: Intensity: 0 to 80 ma peak Pulse type: rectangular symmetrical biphasic pulses Pulse Width: 30 µs to 410 µs Frequency: Variable from 1 Hz to 250 Hz Burst mode - Burst of Rectangular Pulses 4 pulses per burst pulse separation = pulse width Pulse frequency: Fixed Frequency Output mode: Surged or Continuous Output configuration: Fixed and burst mode RUSSIAN: Current type: 2 khz Rectangular Biphasic AC Amplitude Modulated Page 28 of 38

29 Intensity: Modulation frequency: Output mode: MICROCURRENT: Intensity: Pulse type: Waveform duty cycle: Frequency: 0 to 80 ma Default 50 Hz Sweep or Fixed Frequency Variable from 1 Hz to 250 Hz Surged or Continuous 0 to 0.85 ma (0 to 850 µa) Rectangular Monophasic Waveform 50 % or 25% duty cycle 1 to 250 Hz GENERAL OUTPUT PARAMETERS: Surge Parameter: Operates in IFC, PREMOD, HI VOLT (& Alt), BIPHASIC (& Burst) and RUSSIAN modes. Cont. ie: Continuous no surging, direct output. 5/5 s, 4/12 s,10/10 s,10/20 s,10/30 s,10/50 s Treatment Timer: Selectable range: Default setting: 1 to 60 minutes 15 minutes. ELECTRICAL SAFETY: Manufactured to Australian standards: AS Definitions and general requirements for electrical materials and equipment. AS Approval and test specification - Electromedical equipment - General requirements (direct equivalent of IEC 601-1, 1988, Second edition). Applied parts: Patient circuit classification: Device classification: Patient Connections (All modes) BF Class 1 Equipment DIMENSIONS: Width Height Depth 250 mm 130 mm 270 mm WEIGHT: Packed Unpacked 4.5 kg 2.5 kg ENVIRONMENTAL CONDITIONS: Operating: Temperature Range o C Relative Humidity 30% - 90% Transport & Storage: Temperature Range 0-70 o C Relative Humidity 10% - 90% Page 29 of 38

30 11 WAVEFORMS 11.1 Interferential (IFC) Note: All waveforms measured with 500 ohm load 4 khz Carrier 10 Hz Beat Frequency 20 ma Current Setting 11.2 Premodulated Interferential (PREMOD) 10 khz Carrier 150 Hz Beat Frequency 16 ma Current Setting 11.3 High Voltage Pulsed Galvanic (HI VOLT) 7 us Exp Dual Pulse 40 us Pulse Separation 150 Hz Repetition Rate 35 Volt Setting Page 30 of 38

31 11.4 BIPHASIC Stimulation 100 us Biphasic Pulse 150 Hz Repetition Rate 40 ma Current Setting 11.5 BIPHASIC Burst Stimulation 100 us Biphasic Pulse (Burst of 4 Pulses) 150 Hz Repetition Rate 40 ma Current Setting 11.6 Russian/Kotz Stimulation (RUSSIAN) 2 khz Carrier 50 Hz Beat Frequency 20 ma Current Setting Page 31 of 38

32 11.7 Russian/Kotz Stimulation (RUSSIAN) 2 khz Carrier 50 Hz Beat Frequency 20 ma Current Setting 11.8 MICROCURRENT Stimulation 50 Hz Pulse Frequency 50 % Duty Cycle 800 ua Setting Page 32 of 38

33 12 ABOUT US Metron Medical Australia - Design and Manufacture Metron Medical have been designing and manufacturing electrotherapy for over 25 years in Melbourne, Australia. Metron has been successful in Australasia and throughout Europe and the Americas. With the valuable clinical input from Practitioners, University and Research institutes, product development is considered an ongoing process, and we are proud to have been an integral part of the Multistim development and look forward to taking this new technology further in to the future. With a focus and commitment to quality, Metron has achieved various quality standards, including ISO13485, CMDCAS and CE certification. Also, Metron is regularly audited to maintain FDA clearance and TGA accreditation for the entire range of products. If you, as a user of the Multistim and this manual, have any relevant comments or questions, on either the equipment or the manual, your communication with us would be welcomed. You may contact us by mail, or fax as detailed below: Metron Medical Australia Pty Ltd P.O. Box 2164 CARRUM DOWNS AUSTRALIA 3201 Fax: (03) from within Australia, or International sales@metron.com.au Page 33 of 38

34 13 WARRANTY STATEMENT Metron Medical Australia Pty Ltd., will warrant this device/instrument/appliance (excluding accessories) against defects in manufacture for a period of two years from the date of purchase. Accessories including patient leads, cables and electrodes will be covered under this warranty for a period of three months from the date of purchase. - PROVIDING - The instrument has not been serviced by persons not authorized by Metron Medical Australia Pty Ltd., and has not been misused or tampered with and has been used on the correct voltage as branded on it. - THIS WARRANTY EXCLUDES - Parts of the device/instrument/appliance failure of which in the opinion of the dealer of manufacturer is a result of misuses or abuse or any other reason not directly attributed to fault in manufacture. Batteries are excluded from this warranty except where it can be demonstrated that any battery failure was caused by a malfunction in the Multistim. This warranty also excludes glass or ceramic portions. - IN THE EVENT OF FAILURE - The complete device/instrument/appliance should be returned to the dealer from which it was purchased or to the nearest authorized service agent, together with a full report, freight paid and insured. - UNDER NO CIRCUMSTANCES - Shall Metron Medical Australia Pty Ltd., or their agents or dealers be liable in any manner whatsoever for any compensation or damages to any person occasioned by this device/instrument/appliance for any loss, injury or any damage occasioned by or as a result of the misuse or abuse of this device/instrument/appliance. - LOSS IN TRANSIT - The warrantor does not accept any responsibility for loss or damage to the device/instrument/appliance in transit. Any express or applied conditions, statements or warranty, statutory or otherwise (save specifically provided above) is hereby excluded. Page 34 of 38

35 14 EC DECLARATION Metron Medical Australia Pty Ltd, 57 Aster Avenue, Carrum Downs, Australia, 3201 declares that the medical devices described hereafter: Metron Multistim Neuro-muscular Stimulator Model: MS 100 is in conformity with the harmonised international standard EN ; 1990 including amendments. is in conformity with the harmonised international standard EN , is in conformity with the harmonised international standard EN , is in conformity with the essential requirements and provisions of Council Directive 93/42/EEC. is subject to the procedure set out in Annex II of Directive 93/42/EEC under the supervision of Notified Body Number 0805,Office of Devices, Blood and Tissues - Therapeutic Goods Administration, PO Box 100, Woden, ACT 2606, Australia. Ashley Williams Managing Director Metron Medical Australia Pty Ltd 15 th March 2011 Page 35 of 38

36 15 CE MARK 0805 The Metron Multistim Biofeedback System bears the above marking in accordance with the requirements of Council Directive 93/42/EEC. Should you as the purchaser and/or user of this product wish to make any comment about the product or the manner in which it may be used our Authorized Representative within the European Union may be contacted as follows: Metron Medical c/- Patterson Medical Ltd Nunn Brook Road, Huthwaite, Sutton in Ashfield, NOTTINGHAMSHIRE NG17 2HU UNITED KINGDOM Page 36 of 38

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