CALMARE Model MC-5A Non-Invasive Pain Therapy Treatment
Contents
1. Set the channels amplitude to the maximum value of the threshold of tolerance of individual patients Do not exceed this threshold as it does not improve the therapy e The ideal setup threshold is the one that enables the subject to feel stimulation on both electrodes of every active channel that does not provide discomfort e If more than one channel is used set one channel at a time and after having verified its pain relieving efficiency proceed to setting the other channel e If the electrode placement is not effective and there is no affect the channel must be set to zero and the electrodes position must be changed and the setup operation repeated e Discontinue use if the signal is felt only on one of the two electrodes Check the position to ensure correct operation e Ensure that the patient does not have pain or discomfort under the electrodes In this case the electrodes must be repositioned slightly away from the area chosen to eliminate the problem and achieve the analgesic effect Failure to follow these indications can lead to undesirable effects during or after the treatment e Impulses emitted by the device frequently vary and the patient must be informed that he she will often have various sensations at the electrode site e Ensure that positioning is correct from an electronic and operational point of view by asking the patient whether he she is able to feel the pain after every channel has been turned on If2. and stored Please note that for safety reasons it is impossible to disable the sound alerts Competitive Technologies Inc November 25 2008 Calmare Therapy MC 5A Operators Manual Page 19 5 Troubleshooting Problem Solution It is impossible to turn the MC 5A on Verify the connection to the power supply unit and the electrical power network If all is in place call for assistance The MC SA starts at a different time from The previous therapy has not been completed Cancel the the one set therapy and restart the procedure The line error message appears Check the cabling and verify the presence of faulty cables wrongly connected electrodes without or with insufficient GEL If the problem persists call for assistance One or two channels do not work Turn the device off and on once again If the problem persists call for assistance In the ready position synthesis module s Turn the device off and on once again If the problem vertical warning signals do not flash persists call for assistance During treatment synthesis module s Tum the device off and on once again If the problem vertical warning signals are fixed persists call for assistance 6 Maintenance The system with the exception of a routine check of the cables to be connected to the patient does not require ordinary maintenance and or calibration operations No fluids should be used to clean the outside area
3. e Periodic cleaning of connection cables to patient with commercial non oily disinfectants e The device should not be used on open wounds or in contact with other biological fluids 7 Technical Support GEOMC Co Ltd 17F Samsung Fire B D 1329 Seocho 2Dong Seocho Gu Seoul Korea Tel 82 2 586 6871 Fax 82 2 3486 0445 Made in Korea for Competitive Technologies CE 0470 Competitive Technologies Inc November 25 2008 Calmare Therapy MC 5A Operators Manual Page 22
4. ends Competitive Technologies Inc November 25 2008 Calmare Therapy MC 5A Operators Manual Page 8 of each cable there are 4 mm plugs with a snap type connection If different types of electrode connections are required do not modify the cable but simply replace the adapter Picture of the cables electrode side and plugging into the MC 5A 5 Electrodes are inserted by pressing on the button connection 6 Completely rotate the 5 knobs counterclockwise on the front panel 7 Once these tasks have been completed the device is ready for use and can be turned on To modify the default operating parameters it is possible to change the setup as explained in the Setup section Competitive Technologies Inc November 25 2008 Calmare Therapy MC 5A Operators Manual Page 9 4 2 Controls and Functions Control Guide The 5 channels are equipped with a series of warning lights to constantly monitor the proper operation of the device correct cabling and its functioning CHANNEL DESCRIPTION REF DESCRIPTION Rdy Indicates channel on hold output level on zero and ready to use Sen Service Monitor normally quickly flashing Fdk Normally on if channel is up and running Ok Normally on if channel is up and running Hld Normally quickly flashing if channel is up and running Meter Displays the stimulus intensity applied 10 70 Out Connector of the output wire Level Manually regulates stimulus magnitude Descriptio
5. the patient responds with any answer other than no please set the channels to zero and begin again 4 7 Activation of a Therapy When turning MC 5A on check if there are any previously stored treatments that have not been completed This happens when the device is turned off before the treatment has been completed which will be automatically stored When the device is turned back on the memory enables an automatic restart of treatment from where it was interrupted This is useful when the shutdown is erroneous or due to a power outage If shutdown occurs a clear message is displayed and there are two options The first one is to restart the therapy in memory following the same steps as Competitive Technologies Inc November 25 2008 Calmare Therapy MC 5A Operators Manual Page 16 previously described start a new treatment This is useful if the treatment was interrupted for a short term power outage and the same patient must complete the treatment In this case the start time is the moment when the treatment was interrupted The second option is to cancel the therapy in memory To do so one must push the B right and A left navigation buttons simultaneously for a few seconds at the same time Once the therapy is cancelled the warning message will disappear Calmare Therapy Therapy in memory lt Ready to start gt 1 Before increasing the level of the channel ensure the cable is connected correctly betwe
6. CALMARE Model MC 5A Non Invasive Pain Therapy Treatment Scrambler Technology User s Manual International Version CE 0470 Competitive Technologies Inc November 25 2008 Calmare Therapy MC 5A Operators Manual Page 1 Table of Contents Item Page le Indications Tor Use iu iac edet on e ere ben d c qu ers ded aeter bu laa 3 2 Device Descriptions ereen een D LU 3 Zw Device Control ited athe Sant eae cantare Re asia asda are e T 4 2 2 Device Indicators denec e es user tides tv desi me ase a osa au cde 5 2 3 Device Supplies Nee doceo cb estar Rone De 5 3 Warnings and Contramdicatlons use cus be rte ee eda oed tenda epe ee eR Kern Pa ena en 6 3A YW ou eee IRE 6 3 2 CONEERTHEHGACIOTIS eoe eite be n tor ten Ree RE meee ee atu ee 6 33 Precautions vede a a ce dct MM EA LL 7 4 Preparation for D SB eso eoe Ade bota ae aee oaeaeei E a iea aaa esie f A Instructions for Use oa eoe etos cases oed ten edet dedu Erico E DU d SEC 8 4 2 Controls and Functions aa Lo etse hern Ren eser enean vo eto e o Eee agE 10 4 3 TreatimentiProtocol sie centu bu ta sb cota a a aus dede 11 dd SEU esee uos te bode te uestes dud e t eter iet Use 11 45 Placement ot EIeetrodes iiec eade d ec R dati cs E E 11 4 6 Settings for Correct DI SaSO cs eie ei Stet E tim Smet bei e eem 16 4 7 Acugatonofa Therapy secado d per b SO Cade dE Qu DR ce 16 4 8 Tnterr ption ofa Therapy usan niat i visae qi int red URGET ARR rivi 19 i s TrollblesoOLWHg
7. al Treatment Positioning If it is difficult to identify pain free areas useful for treatment it is possible to use advanced positioning strategies that usually solve the problem A strategy is to use contralateral areas Please see the examples below in Figure 3 rs Figure 3 Additional Placement Positioning Note All described positioning types are valid for any area of the body In the example on the left a diagonal X shaped is used for positioning channels 1 and 3 and channel 2 vertically The figure on the right demonstrates the diagonal placement of channels 2 and 4 and channel 1 placed vertically and Competitive Technologies Inc November 25 2008 Calmare Therapy MC 5A Operators Manual Page 14 channel 3 horizontally These examples provide various positions that cover the pain area in several directions These examples require the use of multiple channels When using these examples please remember the following e It is important to remember that the sign of correct treatment and electrode placement is the reduction of pain in the areas involved e In cases when the pain occurs only in specific positions make sure to position electrodes and monitor efficacy only when there is pain otherwise the therapy cannot be effective Once you are certain of the correct positioning the patient can choose the position he is more comfortable with to continue the treatment e In difficult cases always try one channel at a tim
8. cede eu don Deique enis esum unio da c P Mn ened 20 6 MAIBtelanceoso seo dene eie ete tee Een a RAE P E 20 Gol F Replacement cyto etu estet ED uei eR nae 20 6 2 Cleaning and DISIDEGCLHOTI sec soris ch eoe erra dde tup Dec du Notus bod bus aes 22 T Technical Supporta itte Ote te Rose Nasce Dou ueque det tic tue cus ntt 22 Competitive Technologies Inc November 25 2008 Calmare Therapy MC 5A Operators Manual Page 2 1 Indications for Use The Calmare Therapy MC 5A is indicated for use in the symptomatic relief of chronic intractable pain post surgical and post traumatic acute pain 2 Device Description The Calmare Therapy MC 5A is a 5 channel transcutaneous electrical nerve stimulator which provides stimulation based on a stored treatment program Up to 5 pairs of electrodes can be placed on a patient s body to provide relief from chronic pain It can be used by physicians nurses therapists and trained medical personnel Two microprocessors operate to ensure proper function of the unit and the treatment program The treatment program operates automatically once the device is turned on and an output level is set on the amplitude control for each channel to suit the patient s sensitivity to the stimulation The electrodes are placed in tandem at points around the area where pain is experienced to provide relief CAUTION Federal USA law restricts this device to sale by or on the order of a physician General Features Po
9. e checking its efficacy If the time required for positioning reduces the length of the actual treatment you should set the levels of each channel to zero without changing the positioning then interrupt the therapy through the specific controls and start it on again to carry out a full treatment correctly e During the treatment the stimulation might be perceived with minor intensity because of the pain relieving effect In this case it is necessary to increase the levels of the channels involved until the patient reports he she clearly perceives the stimulation Therapy Duration In most sessions the treatment lasts 30 to 45 minutes but can run anywhere between 20 and 60 minutes in length Treatment Initiation The treatment automatically starts when the level of any channel is raised and automatically stops at the end of the duration previously set The treatment is completely automated and does not require setting up of individual wave parameters such as frequency duty cycles scanning etc The only manual procedure required is the regulation of the stimulus magnitude to be customized to the patient s individual sensitivity In case of power failure the treatment picks up again from interruption time but it is also possible if necessary to manually cancel it and then restart the treatment Competitive Technologies Inc November 25 2008 Calmare Therapy MC 5A Operators Manual Page 15 4 6 Settings for Correct Usage e
10. e modified Then by pressing OK the duration is confirmed and the Setup is complete SET TIME WRITE 30 4 5 Placement of Electrodes Each channel is connected to two electrodes through specific connectors a red one and a black one Excluding some specific cases the electrodes must be placed slightly outside the pain area It is necessary to identify each pain area before placing the electrodes The best method is to ask the patient to exert a light pressure on the skin with a finger until he she finds the boundaries of the pain area to be treated Competitive Technologies Inc November 25 2008 Calmare Therapy MC 5A Operators Manual Page 11 Each channel s two electrodes red and black pair must be positioned 2 to 3 inches away from the area of pain as shown in the figure below Vertical placement Horizontal placement m A Figure 1 Example Electrode Patients the numbers on electrodes indicate the channel Please note in the above example that in the first case the electrodes have been placed vertically and in the second case the electrodes are placed horizontally passing through the center of the pain area The positions of the electrodes correspond to some forms of pain that respond better to a vertical placement and other forms of pain that respond better to horizontal placement Please note the following regarding electrode placement e The red and black paired electrodes of each chann
11. el can be placed either vertically or horizontally e All the vertical placements must have the same color electrodes of each channel on the same side The same is true for horizontal placements If this rule is not followed the pain killing effect drops For example if channel 1 and 2 are placed vertically and the red electrode of channel 1 is placed on the top then the red electrode of channel 2 will have to be placed on the top If the black electrode of channel 1 is placed on the top then the black electrode of channel 2 must be placed on the top e If the red electrode of channel 1 is placed on the right the red electrode of Competitive Technologies Inc November 25 2008 Calmare Therapy MC 5A Operators Manual Page 12 channel 2 must also be placed on the right and so on e Chronic pain should be treated using the electrode pairs of several channels An example of chronic pain is low back pain Usually the low back pain area must be treated with one or more channels according to the extent of the pain area with a horizontal placement The part of pain that spreads to lower extremities passing through the gluteus must be treated with a vertical placement These two types of placements are used simultaneously during the same treatment session The following illustration Figure 2 is an example of placements that concurrently use more channels vertically or horizontally vertically The numbers on the electrodes correspond to t
12. en the channel output and the electrodes Even if not necessary it is preferable to put another drop of gel on the conductive part of the electrode placed on the skin NEVER REUSE patient electrodes 2 Very slowly rotate the channel control handle until a relay click is heard and service information will be shown on the display The warning signal OK will appear while RDY will turn off If this does not occur the cable connection is incorrect and the level control must be completely rotated counterclockwise to set the channel to stand by mode Subsequently the entire operation must be repeated after completing the positioning checks 3 Continue to very slowly rotate the control knob intensity until the patient feels the stimulation from the channel that is being used It is normal to perceive one of the two electrodes more intensely Once the treatment is underway the Display will show the time left to the end of the treatment the activation of the end of therapy alert sound and the current status of the therapy Scrambler active Time Out 10 min Beep On Phase 1 4 This operation needs to be repeated for each channel used 5 For the correct functioning the warning lights Ok Fdk must be consistently lit The letters Sen and Hld will flash consistently 6 During the set up if the warning light OK turns off an alert signal is Competitive Technologies Inc November 25 2008 Calmare Therapy MC 5A Operators Man
13. he channel For example red 1 and black 1 are the electrodes that use channel 1 red 3 and black 3 are the electrodes connected to channel 3 and so on Horizontal and Vertical Vertical Assembling Assembling n i li Figure 2 Example of Multiple Channel Use Important Notes When using Multiple Channels a Start by preparing to use only one channel according to the descriptions above Once the connections have been made the level is adjusted following the descriptions above Competitive Technologies Inc November 25 2008 Calmare Therapy MC 5A Operators Manual Page 13 b Incase the pain is reduced but it is still present in some areas while the first inserted channel is active add another one to extend the treated area following the same instructions After having verified the pain relief of the new inserted electrode and channel continue treatment until the complete disappearance of pain c If the addition of electrodes and channels do not produce results set the level to zero and use a different electrode placement repeating the operation of set up and efficacy control d Proceeding through a number of subsequent attempts one can quickly understand when electrodes are correctly placed because pain immediately disappears from the treated area By using this feedback it is possible to resolve the most complex situations thanks to the immediate response of full or substantial relief of the pain symptoms Addition
14. hts which constantly monitor the proper operation of the device correct cabling and its functioning Channel Indicators REF Rdy Scn Fdk Ok Hld Meter Out Level DESCRIPTION Indicates channel on hold output level on zero and ready to use Service Monitor Normally quickly flashing Normally on if channel is up and running Normally on if channel is up and running Normally quickly flashing if channel is up and running Displays the stimulus intensity applied 10 70 Connector of the output wire Manually regulates stimulus magnitude 2 3 Device Supplies 10 Self Adhesive disposable surface snap electrodes pretreated with Gel 5 Lead wires with connectors as shown 3 AC Power Supply 220 Volt 50 60 Hz 4 Instruction Manual instructions for use by physician or by trained medical personnel Competitive Technologies Inc November 25 2008 Calmare Therapy MC 5A Operators Manual Page 5 3 Warnings and Contraindications 3 1 Warnings The safety of the Calmare MC 5A device for use during pregnancy or labor has not been established The Calmare MC 5A device may not be effective for pain originating in the central nervous system This includes headaches The Calmare MC 5A device should be used only under the continued supervision of a physician or trained medical personnel The Calmare MC 5A device does not cure the underlying cause of the pain The Calmare MC 5A device provides a symptomatic treatme
15. irritation may occur at the site of electrode placement following long term application e Caution should be used for patients with suspected or diagnosed heart problems e Caution should be used for patients with suspected or diagnosed epilepsy e Effectiveness of the Calmare MC 5A device is highly dependent upon patient selection by a person qualified in the management of pain patients e Caution should be used when treating in the presence of the following e Patients with a tendency to hemorrhage following acute trauma or fracture e Painful area over the menstruating or pregnant uterus e Areas of the skin that lack normal sensation e Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation electrical conductive medium or stainless steel electrode array The irritation can usually be reduced by using an alternate electrode placement e Electrode placement and stimulation settings should be based on the guidance of the prescribing practitioner e Avoid use of electrodes conductive gels lead wires or accessories other than those supplied with the system or recommended by Competitive Technologies The safety of other products has not been established and their use may result in skin irritations and burns beneath the electrodes 4 Preparation for Use e To correctly function in the required conditions of use the device needs an electric system fitted with an automatic circuit breake
16. n of Synthesis Module Panel MC 5A is a system that uses two microprocessors operating in correlation though operating independently One is fully used to manage code synthesis To verify the correct functioning of the module it is sufficient to check warning lights M1 through M7 When the device is turned on they light up in sequence and then flash in sync indicating the stand by and correct program operation During the therapy at short intervals warning lights go on and off in a random manner This activity enables the device to constantly monitor the correct operation of the module and program in a dynamic way Competitive Technologies Inc November 25 2008 Calmare Therapy MC 5A Operators Manual Page 10 4 3 Treatment Protocol e To guarantee the most effective and lasting pain relief the treatment should last 30 45 minutes but it is possible to set up from 20 to 60 minutes e The treatment should include cycles that can be repeated made up of 10 treatments at least to be carried out at a frequency of 5 times a week 4 4 Setup e If the MC 5A has not been set up default options will be active that establish the treatment duration Therapy Duration e 30 min to 45 min it can be set from 20 to 60 min e To intentionally change this Setup press buttons C Up and D Down simultaneously until the Setup menu appears ex SET TIME TIME 30 e Using navigator buttons Up Down the therapy duration can b
17. nt and as such suppresses the sensation of pain which would otherwise serve as a protective mechanism Keep out of reach of children Electronic monitoring equipment such as ECG monitors and ECG alarms may not operate properly when the device is in use The long term effects of chronic electrical stimulation are unknown Stimulation should not be applied over the neck or mouth Severe spasm of the laryngeal and pharyngeal muscles may occur and the contractions may be strong enough to close the airway or cause difficulty in breathing The use of this device is forbidden in the presence of inflammable anesthetic gases 3 0 Contraindications DO NOT use on patients with metal implants such as pacemakers automatic defibrillators aneurysm clips vena cava clips and skull plates However the Calmare MC 5A device CAN BE USED on patients with metal implants such as total knee hip shoulder and other joint replacements as well as on patients with implanted pins clips screws plates and cages used for orthopedic repair DO NOT place electrodes on the carotid sinus front of neck region of the body DO NOT place electrodes on the head unless under direct supervision of the clinician Competitive Technologies Inc November 25 2008 Calmare Therapy MC 5A Operators Manual Page 6 e DO NOT use on patients prone to seizure for example epileptics e DO NOT use on undiagnosed pain 3 3 Precautions e Isolated cases of skin
18. of the device but simply a simple duster If necessary for a thorough cleaning use a cloth soaked in alcohol after having disconnected the device from the main power supply After cleaning carefully check whether the wiring for correct operation has loosened and if so tighten the cables 6 1 Fuse Replacement The device has two fuses on the network that whenever necessary must be replaced with others of the same value 0 8A The user can change only one of the two fuses that are accessible from outside If the inner fuse must be replaced the manufacturer must be called to send an authorized technician to carry out the procedure To replace the external fuse inside the mains cable tray it is necessary to 1 Disconnect the main cable if present 2 Push the unlock lever and extract the fuse holder with the use of a small flat blade screwdriver Competitive Technologies Inc November 25 2008 Calmare Therapy MC 5A Operators Manual Page 20 Remove the fuse and replace it with one of the same value 3 Re insert the new fuse in the fuse holder in the appropriate lock Correctly position the entire fuse holder in its slot gently pushing it in until it locks Competitive Technologies Inc November 25 2008 Calmare Therapy MC 5A Operators Manual Page 21 6 2 Cleaning and Disinfection MC SA is not a sterile device Please follow the following e Disposable electrodes to be replaced after every treatment
19. ot place it again on the patient before having set to zero the channel intensity level or related alarm If you do not follow this procedure the patient may feel a slight shock that is minor in nature Even when the protection system is on remember it will always react a couple of seconds after a connection fails Operational Checks The patient should feel immediate pain relief and no stimulation trouble during use Any discomfort should be evaluated immediately If the correct treatment areas are difficult to find a response that produces a partial pain relief is acceptable as long as the patient does not feel a stimulation discomfort 4 8 Interruption of a Therapy e To cancel a therapy press the two navigator A right and B left buttons at the same time and wait for the message confirming the interruption e The treatment must not be interrupted by turning off the device otherwise the subsequent treatment could start from the amount of time that has not been used in the previous one Complete therapy Zero levels Activate Deactivate END OF TREATMENT ALERT SOUND During active therapy press the OK button in the middle of the navigator to switch on Beep On the display or switch off Beep off on the display the end of treatment sound alert This command is stored every time the treatment is turned on Every time the device is turned on the Beep on beep off status will be the same that was more recently set
20. r and earthing in the power point used for the system e MC 5A is a device specifically designed for hospital and outpatient facilities It s easily transportable and mechanically robust Competitive Technologies Inc November 25 2008 Calmare Therapy MC 5A Operators Manual Page 7 4 1 Instructions for Use 1 In order to operate the MC 5A must be placed on a flat stable surface 2 Cable assembly will follow the steps illustrated in the power cabling picture below 3 Position the power supply unit near the MC 54A Plug the network cable into the adapter s empty socket and the power source 220 230 V 50 60 Hz checking its regulatory compliance in that it must include a grounded socket and automatic cut out on the power line The MC 5A must be compliant to increase its operational safety to avoid accidents The MC 5A has a further set of independent protection measures such as low voltage picked up in the output by the power supply unit that drives another low tension power transformer separator contained inside plus an outbound transformer separator that in a galvanic way isolates every channel from low voltage power supply and from other channels rapid self restoring fuses and patient insulation relays 4 Connect electrode cables in the appropriate socket in every channel by gently inserting the plug making sure it is snug and then locking the cable to the device by turning the metal collar clockwise until tight At the
21. ual Page 17 immediately displayed with a feedback absent message The turning off of the warning light Ok can be caused by Broken or short circuited cable Cable disconnected from the electrodes Bad electrode contact Insufficient or deteriorated gel on the electrodes Feedback absent 1 Zero levels 2 Check cables 3 Restart 7 To stop the alert signal set the outbound levels of all channels to zero After having checked and corrected the anomaly the channel can be again used without having to cancel and restart the treatment 8 During normal operation the meter will show a different position according to the power requested the rotation of the level control dial and the limit set for power supply under safety conditions that is automatically adjusted This leads to a non linearity between the increase in the rotation of level control and the indication of actual power delivery influenced by the feedback loop of the circuits controlling the forwarding of Scrambler codes and skin impedance The ratio of the level control rotation and meter indication varies from patient to patient Please note that this difference from patient to patient depends on the area that is being treated individual sensitivity and alterations in pain perception Competitive Technologies Inc November 25 2008 Calmare Therapy MC 5A Operators Manual Page 18 Caution If an electrode or cable is disconnected do n
22. wer Supply 200 240V 50 60 Hz Waveforms Artificial biopotentials modulated for digital synthesis with Scrambler codes international patent made of impulse sequences strings of max amplitude 42 A C dual True RMS on fictitious load of 10 kohm Average wave train frequency lt 80 Hz Electrode features Disposable surface electrodes pretreated with GEL in fabric non fabric Ag Ag Cl Competitive Technologies Inc November 25 2008 Calmare Therapy MC 5A Operators Manual Page 3 A representation of the Stimulation Waveform is found below 500 Q load CHI DXX Maintigk gt F WWW WE O3SmS o a E s esses Output Voltage 11 875 V p p Output Current 23 78 mA p p Output Frequency 43 Hz Output Frequency Range 42 53 Hz Output Voltage Range 11 875 118 75V p p Output Current Range 11 875 23 78 mA p p 2 1 Device Controls Channels Synthesis Control panel e On Off switch in the lower right hand corner marked Power e Front panel contains 5 knobs marked level which control the stimulation output of the treatment Competitive Technologies Inc November 25 2008 Calmare Therapy MC 5A Operators Manual Page 4 e Navigation buttons A left B right C up D down Ok according to the layout displayed They enable to modify the setup to switch the end of treatment alert on and off and to cancel a therapy 2 2 Device Indicators e The five channels are equipped with a series of warning lig
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