ACP OMNIVERSA, User Manual

Page 1: ...ot be used for any other purpose Any additional copies of the Manual shall be ordered from ACP No changes or modifications shall be made to the Manual without prior review and written authorization from ACP No authorization is given to market sell disclose or exploit this Manual except as for purposes of using the Equipment as contemplated by the Lease Agreement ACCELERATED CARE PLUS MAKES NO WARR...

Page 2: ...py Therapeutic Ultrasound Pulsed Shortwave Diathermy devices and advanced Therapeutic Exercise Systems Our MEGAPULSE NEUROPROBE OMNISTIM OMNISOUND OMNICYCLE OMNIVR OMNISTAND OMNIVERSA OMNISWD and SYNCHRONY represent the most recent worldwide advances available for therapeutic application of electromedical devices and other rehabilitation technology ACP is internationally recognized for its contrib...

Page 3: ...ying documents Caution electrical precautions Remote Control connection CE mark of confidence compliant to MDD 93 42 EEC Connection Electrode Cable IP2X Classification against intrusion of water dust accidental contact of a body part Proper disposal required Do not dispose of with regular household waste Follow state and or local regulations Alternating current device Observe the user manual Consu...

Page 4: ...S PRECAUTIONS 28 Warnings 28 Precautions 29 Ultrasound Menu Navigation 29 Combination Therapy Menu Navigation 33 TREATMENT GUIDELINES 465 Introduction to Medium Frequency Currents 46 Electrode Application Techniques 47 Treatment Preparation 52 Definitions 60 Universal Precautions Body Substance Isolation 60 Cleaning Disinfecting of the OmniVersa 60 Cleaning and Low Level Disinfection 60 Intermedia...

Page 5: ...herapy for the treatment of medical diseases and conditions Contraindications Do not use this device on patients who have a cardiac pacemaker implanted defibrillator or other implanted metallic or electronic device because this may cause electric shock burns electrical interference or death Note There is no contraindication to the application of Transcutaneous Electrical Stimulation or Powered Mus...

Page 6: ...hrough induction convert it into an electrical field transmit the energy into the patient increasing the current density at the electrodes of applicators Since the patient may not feel the 27 MHz frequency they lack the protective sensation and tissue burns could result Short wave field could potentially damage or reset medical devices in close proximity to the drum applicator Treatment should not...

Page 7: ...ice outer casing has been in part or fully removed Only qualified service personnel should perform Service and repairs Warranty will be voided if the outer casing has been removed or tampered with Use caution when the patient has a tendency to bleed internally such as following an injury or fracture Do not apply over areas of hemorrhage or active bleeding Inspect and cleanse the skin prior to appl...

Page 8: ...cle contraction may disrupt the healing process Caution should be used for patients with suspected or diagnosed epilepsy Patients with suspected or diagnosed epilepsy should follow precautions recommended by their physicians Electrodes should not be placed in direct contact or in close proximity one inch or less of each other during treatment Electrodes placed in contact or in close proximity can ...

Page 9: ...dependent channels With independent channels two different protocols can be performed simultaneously The OmniVersa ultrasound therapy section provides two positions for attachment of an ultrasound applicator Depending on the device configuration ordered the Omnisound Professional comes with an applicator with a large contact area an applicator with a small contact area or with both applicators The...

Page 10: ...ed muscle The OmniVersa provides High Voltage Pulsed Current HVPC on two channels Continuous or surged operation with fully adjustable ON and OFF times and ramps allow applications of HVPC therapy Increasing circulation pain control and neuro muscular re education can be set up in this mode The OmniVersa provides Patterned Electrical Neuromuscular Stimulation PENS EMG based function patterns adjus...

Page 11: ... programmed by the therapist E OUTPUT CHANNEL B Electrotherapy channel F OUTPUT CHANNEL C Multifunction connection used for Ultrasound Applicators G OUTPUT CHANNEL D Multifunction connection used for Ultrasound Applicators H POWER LED INDICATOR Green Device plugged in and battery is charging Orange Device is operating on battery B MAIN POWER SWITCH backside of unit Mains power supply ON and OFF sw...

Page 12: ...Attach remote controls There are two types of remote controls the Patient Safety Switch and the Clinician Hand Control Attachment of a USB stick used for backing up and restoring Favorite programs and by ACP employees for software updates CAUTION The supply current of this connection is limited to 100 mA Do not connect USB mass storage devices such as USB powered hard disks as this might result in...

Page 13: ...clinicians To adjust these default settings proceed as follows 1 From the Home screen select System Settings using the touch screen You will then be able to adjust the factory settings 2 Settings can be changed by selecting the current value and use the dial to scroll through the available choices Select another setting using the touch screen to lock in the selected value 3 The new settings will b...

Page 14: ...power cord to OFF to stop charging and to disconnect the unit from the mains supply Installing Replacing the battery Remove the power cable from the power line inlet Turn the device upside down and on a soft surface Remove the two screws from the battery cover using the supplied screwdriver Slide and lift the battery cover Align the battery on the bottom of the main unit with the polarity of batte...

Page 15: ...n this message is displayed the battery level is critically low and the system is locked You should connect the system to mains power and then restart Navigation Icons Button Meaning Back return to previous screen Home return to Home screen The information button which provided access to the embedded clinical libraries Page number number of pages in multi page menu screens Store therapy settings o...

Page 16: ... channel or when no channels are selected the menu buttons H CHANNEL TAB Used to select a channel and to display and adjust the output amplitude of that channel The visual display is organized as a series of menus that provide access to groups of parameters for each channel The output channels are located on the front of the unit labeled as A B C and D The menu can be selected by touching its chan...

Page 17: ...ary Indications Manual Mode Favorites Contraindications Select Indications by touching the button and the Electrotherapy Indications menu appears Electrotherapy Indications Menu Use the Rotary Selector Dial to scroll through the list and select the indication by touching the button The number of pages in a menu is displayed in the navigation bar i e 1 3 Indications list includes the following Post...

Page 18: ...ctrode placement illustrations Use the Rotary Selector Dial to scroll through the pages Touch the OK button in the navigation bar to proceed to channel selection or the parameter menu Note Preset 2 channel programs will proceed to the parameter menu Electrotherapy Protocol Electrode Placement Illustrations Use the Rotary Selector Dial to scroll through the illustration pages Touch the OK button in...

Page 19: ...or to removing electrodes Note PENS will default automatically to two channel mode A B Electrotherapy Parameter Adjustment Changing parameters All parameter settings are changed by the same two step process 1 Select touch the parameter which will then illuminate bright white The example shown is Treatment Time 2 Changes are made using the Rotary Selector Dial Within 12 seconds of making the change...

Page 20: ... it will illuminate orange Setting Output Intensity Simultaneously 2 Channel Program If a 2 channel application is selected to simultaneously increase the intensity of both channels press and hold both channel tabs with your fingers until both channel tabs illuminate orange Pausing a Treatment As soon as the Start button is pressed the PAUSE and STOP buttons appear To pause a treatment touch the P...

Page 21: ...nned to record the treatment into the Electronic Medical Record via the ACPlus iOS application Electrotherapy Manual Mode Operation The Electrotherapy menu provides access to the ways you can navigate and the Electrotherapy Contraindications library Indications Manual Mode Favorites Contraindications Select Manual Mode by touching the button and the Electrotherapy Manual Mode menu appears ...

Page 22: ...intensity can be set differently Note All PENS programs will default automatically to two channel mode A B Electrotherapy Parameter Adjustment Changing Parameters All parameter settings are changed by the same two step process 1 Select touch the parameter which will then illuminate bright white The example shown is Treatment Time 2 Changes are made using the Rotary Selector Dial Within 12 seconds ...

Page 23: ... too blue If additional output adjustment is needed prior to selecting START press the channel tab with your finger and it will illuminate orange Setting Output Intensity Simultaneously 2 Channel Program If a 2 channel application is selected to simultaneously increase the intensity of both channels press and hold both channel tabs with your fingers until both channel tabs illuminate orange Starti...

Page 24: ... treatment can also be stopped by pressing the emergency stop icon Pressing this button stops the output on all channels in use Turn Off Unit Do not turn off the unit by means of the mains switch as it will continue operation from the battery power The current will just keep flowing through the patient as if nothing happened and thus it will also flow through the therapist causing them to inadvert...

Page 25: ...l defined for this reason the most prudent course is avoiding ultrasonic therapy over these areas Note There is no contraindication to the application of Ultrasound over metal implants Over or near bone growth centers until bone growth is complete Over the thoracic area if the patient is using a cardiac pacemaker In an area of the body where a malignancy is known to be present In an area of the bo...

Page 26: ... the patient may not feel the 27 MHz frequency they lack the protective sensation and tissue burns could result Short wave field could potentially damage or reset medical devices in close proximity to the drum applicator Treatment should not be applied over the carotid sinus nerves located in the anterior neck triangle including stellate ganglion vagus nerve or laryngeal or pharyngeal muscle Parti...

Page 27: ...eral attempts should be made to place them at ease so that their confidence and cooperation can be gained during the treatment The treatment area should be checked from time to time and if there is evidence of or if the patient complains of pain or overheating during treatment adjust the output downward until it is tolerated by the patient If the patient continues to complain of pain or overheatin...

Page 28: ...me Page Indications Operation The Ultrasound Therapy menu provides access to the ways you can navigate and the Ultrasound Contraindications library Indications Manual Mode Favorites Contraindications Select Indications by touching the button and the Ultrasound Therapy Indications menu appears Ultrasound Indications Menu Select the Ultrasound Therapy Indication by touching its button Indications in...

Page 29: ...ce material and application illustrations that are accessed by touching the information button Ultrasound Protocol Information The embedded clinical library includes protocol and setup information with and example application illustrations Use the Rotary Selector Dial to scroll through the pages Touch the OK button in the navigation bar to proceed to the ultrasound parameters menu Ultrasound Proto...

Page 30: ...put Intensity Output intensity can only be set when the Ultrasound channel tab is illuminated orange Screen text saying Ready to set the output appears during initial setup As soon as intensity is increased the START and STOP buttons appear and the red Stop square at the top of in the channel tab becomes the two bar orange PAUSE Icon Note Within 12 seconds after setting the desired output intensit...

Page 31: ...and the Ultrasound Pulsed Continuous parameters menu appears Note Pulsed Ultrasound Duty factor 5 10 20 25 33 or 50 Pulsed duration is fixed at 2 msec Thermal Delta T modes 1ΔT 2ΔT 4ΔT o Delta T technology only available on the 5cm2 sound head only Ultrasound Parameter Adjustment Changing parameters All ultrasound parameter settings are changed by the same two step process 1 Select touch the param...

Page 32: ...annel tab becomes the two bar orange PAUSE Icon Note Within 12 seconds after setting the desired output intensity the orange illuminated channel tab fades to blue If additional output adjustment is needed prior to selecting START press the channel tab with your finger and it will illuminate orange Combination Therapy Menu Navigation Combination Therapy Home Combination Therapy combines ultrasound ...

Page 33: ...mbination Therapy Indications Menu Select the specific Indication by touching the button on the screen Indications include Pain Management Increase Local Circulation Decrease Muscle Tone Spasm Select Pain Management and the Pain Management Protocol menu appears Combination Therapy Indication Protocols Menu All Combination Therapy Indications have a menu of Protocols that allow the selection of sev...

Page 34: ...ial to scroll through the illustration pages Touch the OK button in the navigation bar and the Combination Therapy parameter menu appears Combination Therapy Menus Ultrasound and Electrotherapy Ultrasound Ultrasound output intensity is set first use the Rotary Selector Dial to set output intensity Screen text saying Ready to set the output appears during initial setup As soon as intensity is incre...

Page 35: ...n To return to the ultrasound parameters menu press the ultrasound button Stopping a Combination Therapy Treatment After the treatment is started to stop the treatment press the STOP button Note The treatment can also be stopped by pressing the emergency stop icon Pressing this button stops the output on all channels in use Combination Therapy Manual Mode Operation The Combination Therapy menu pro...

Page 36: ...is screen the user can adjust the intensity or change the ultrasound parameters by touching the button and changing the value with the Rotary Selector Dial To access the electrotherapy parameters touch the electrotherapy button at the bottom left of the screen Combination Therapy Electrotherapy Menu Electrotherapy In this menu the user can adjust the intensity or change the electrotherapy paramete...

Page 37: ... Favorite Programs Creating a Favorite Program Any treatment program can be saved as a Favorite by pressing the Save button for later use Saving a Favorite Program After you have selected the Save icon the process to save and store in the Favorites library is as follows Enter the name of the favorite using the keyboard Touch the OK button to store your favorite under the name just entered Note Onc...

Page 38: ...d until a new program is selected for use Patient Sensation Change Warnings At the beginning of the Motor Sensory Sensory Motor and Sequential protocols a Pop up will apear instructing the therapist to inform the patient they will perceive different sensations as the frequency changes during these treatments Press the green check mark to confirm and clear the message In addition an auditory tone n...

Page 39: ... single button Patient Saftey Switch intended for patient use during a treatment and one five button Clinician Hand Control intended for clinician during treatment Patient Safety Switch Clinician Hand Control Connecting the Remote Control Insert the end of the remote control Patient Safety Switch or Clinician Hand Control lead wire into the USB Port Note Only one Remote can be used at a time ...

Page 40: ...ll appear saying Remote Control disconnected Press the green check mark to confirm and clear the message Patient Safety Switch Function The Patient Safety Switch has only 1 function to Stop the treatment session Press the STOP button to stop output and end a treatment session Clinician Hand Control Function The Clinician Hand Control has three primary functions 1 Setting Channel A output intensity...

Page 41: ... Small Muscle Asymmetrical Biphasic Hand Control LVPC Medium Muscle Asymmetrical Biphasic Hand Control MFAC Hand Control Select the desired protocol from the options to proceed to the channel selection menu Note Use of the hand control protocols do not require the Clinician Hand Control but can be performed using touch screen as well The following example of use can be applied to all of the Hand C...

Page 42: ...f you have selected a Single Chanel use i e Ch A or B only or a Two Channel use i e Ch A and B together Select Manual to enter the Channel Interactions submenu for a Two Channel setup Note The Channel Timing menu also provides access to electrotherapy Ramp up and Ramp down time and the option to have audible tones heard when stimulation is activated On or Off Channel Interactions Two Channel Opera...

Page 43: ...Interactions are as follows Manual Ch A Ramp Up and Ramp Down Time are preset to 2 seconds Stimulation On time Start Estim and Off time Stop Estim are controlled by the clinician using either the Clinician Hand Control or commands on the Main Display Sequential Simultaneous Ch A Ramp Up and Ramp Down Time preset to 2 seconds Stimulation On Time Start Estim is preset to 10 seconds Stimulation off t...

Page 44: ...e resistance With medium frequency currents the energy of each individual pulse is low providing for stimulation of only one or two neurons Since the pulses are coming in very rapid succession stimulation of surrounding neurons occurs prior to completion of the previous neurons refractory period This allows for asynchronous activation of individual sensory neurons mimicking the natural physiologic...

Page 45: ...mmonly used technique for muscle stimulation This technique utilizes two electrodes but not exclusively of the same size One electrode should be applied over the motor point and the other electrode over the belly of the muscle as far away from the motor point as possible This technique allows for more effective muscle and nerve fiber recruitment since the entire neural innervation of the muscle is...

Page 46: ...DUS WRIST EXTENSOR CARPI ULNARIS EXTENSOR CARPI RADIALIS LONGUS BREVIS FINGERS EXTENSOR DIGITORUM EXTENSOR DIGITI MINIMI Patient may perform therapist directed exercises and or functional activities during PENS induced muscle contractions WRIST AND FINGER FLEXION AND EXTENSION BICEPS BRACHII CH A CH B TRICEPS BRACHII ELBOW FLEXION AND EXTENSION Patient may perform therapist directed exercises and ...

Page 47: ...ENSION Patient may perform therapist directed exercises and or functional activities during PENS induced muscle contractions LUMBAR STABILIZATION BILATERAL PARASPINALLY OVER MULTIFIDUS MUSCLE LEVEL OF UMBILICUS WAY BETWEEN THE ASIS AND THE ANTERIOR MIDLINE OVER THE TRANSVERSE ABDOMINAL MUSCLE Patient may perform therapist directed exercises and or functional activities during PENS induced muscle c...

Page 48: ...ing PENS induced muscle contractions Patient needs to be supine with hip extended GLUTEUS MAXIMUS OR GLUTEUS HAMSTRINGS HIP FLEXION AND EXTENSION BICEPS FEMORIS SEMIMEMBRANOSUS SEMITENDINOSUS RECTUS FEMORIS VASTUS INTERMEDIALIS VASTUS LATERALIS VASTUS MEDIALIS VMO KNEE FLEXION AND EXTENSION Patient may perform therapist directed exercises and or functional activities during PENS induced muscle con...

Page 49: ...ctrodes a minimum of 1 apart Extend the distance between electrodes to achieve deeper current flow and or stimulation of larger areas or multiple muscles Do not place electrodes under hot or cold packs Do not use small electrodes less than 2 x2 when treating with medium frequency currents MFAC or IFC Patient may perform therapist directed exercises in a relaxed toe down position and or functional ...

Page 50: ... patients If skin irritation persists with alternate site applications decrease the treatment times and lower the intensities if necessary discontinue treatment If an allergic reaction is suspected attempt to identify and change the allergic substance s If skin irritation persists discontinue treatment until the source of irritation is determined By far the most common error with reported faulty m...

Page 51: ...ion Therapy Internal connection allows for combination therapy Excellent BNR and ERA Our superior BNR and ERA makes for highly uniform and comfortable applications Automatic Self Test with Problem Identification Allows accurate evaluation and documentation of unit functionality before you begin treatment Ultrasound therapy devices generally consist of a generator and a transducer The generator pro...

Page 52: ...cycle of the ultrasonic radiation carrier wave However ultrasound applicators do not generally produce beams of perfectly uniform intensity over the surface of the transducer When the power is expressed in watts cm2 it provides the output in watts for each square centimeter of effective radiating area on the transducer surface The effective radiating area ERA is a measurement of the surface area o...

Page 53: ...e accurate in order to assure proper treatment dosage Note Care should be taken when applying therapy to move the head continuously over the treatment area Monitoring of Delivered Power or Intensity The power meter displays the ultrasonic power level to be delivered to the patient under proper coupling conditions First apply an ultrasound coupling to the treatment area The output control up power ...

Page 54: ...nation of the treatment area coupling to be used frequency of operation BNR and the desired temperature increase required to achieve appropriate therapeutic effects in the tissue Lehman and other investigators have categorized the effects of ultrasound on tissue as being of a mild or 1 C increase moderate or 2 C increase or vigorous or 2 4 C heating effect above the baseline tissue temperature of ...

Page 55: ...as of anesthesia or lack of temperature sensitivity are found use caution and low doses sub thermal Care should be exercised with these patients as they may not detect damaging thermal effects 4 Use the minimum effective dosage including power and exposure time If more therapy is required a longer time at a lower output is recommended Avoid using maximum power levels For example a typical comforta...

Page 56: ... the pain is reduced If so continue the treatment Note The Delta T mode of operation is calibrated for muscle not in proximity of bone If the ultrasound application at 3MHz is within 1 cm of bone the 2 Delta T mode will heat at a rate of 4 C or the 1 Delta T mode will heat at 2 C Within 5cm proximal to bone the 1 Delta T mode will heat at 4 C due to the reflection of the ultrasound field from the ...

Page 57: ... may allow the ingress of conductive fluid Inspect the treatment head cables and associated connectors The user should handle the US transducer applicator head with care at all times since rough handling may adversely affect its characteristics 2 Determine the appropriate indication or electrotherapy waveform Manual mode best suited to treat the patient s specific condition 3 Select size of electr...

Page 58: ...e parameters and intensity settings 10 Press Start 11 Repeat treatment in adjacent areas to fully treat involved tissue as needed The total treatment time is based upon the dosage selected and the ultrasound intensity Provide the treatment until the end time is reached and the energy outputs cease During Combination Therapy observe both electrotherapy and ultrasound contraindications warnings and ...

Page 59: ...cility infection control policy ACP recommends the following guidelines Cleaning and Low Level Disinfection This is a recommended daily housekeeping practice to keep the equipment clean and free of contaminants which could contribute to transmission of infection The following practices are recommended for use when treating intact skin without the presence of physiologic fluids such as blood and ur...

Page 60: ... follows 1 Wash hands 2 Apply Intermediate Level Disinfection prior to barrier application 3 Select tear or cut with clean scissors a length of barrier film to fit over the operator surfaces of the OmniVersa unit 4 Select and cut with clean scissors a 2 foot length of plastic sleeve and fit over the lead wire and the electrode cabling 5 Prepare any items which may become in contact with the therap...

Page 61: ...D MOTOR 4 MFAC LARGE MUSCLE PELVIC FLOOR 3 TENS LVPC MOTOR Functional Re Education Sport 4 IFC PREMOD MOTOR SENSORY 1 PENS CYCLE 5 SENSORY NERVE BLOCK 2 PENS WALK to RUN Increase Local Circulation 3 PENS SPRINT 1 HVPC SENSORY 4 PENS SKATE 2 MFAC MUSCLE PUMP 5 PENS JUMP 3 PENS MUSCLE PUMP 6 PENS THROW Decrease Muscle Tone Spasm 7 PENS KICK 1 PENS UE BIPHASIC HEAD NECK Maintain Increase ROM 2 PENS U...

Page 62: ... CORP ALL RIGHTS RESERVED MANUAL MODE WAVEFORMS 1 PENS UE BIPHASIC 9 PENS Throw 2 PENS UE TRIPHASIC 10 PENS KICK 3 PENS LE TRIPHASIC 11 IFC PREMOD 4 PENS CYCLE 12 LVPC ASYMMETRICAL BIPHASIC 5 PENS WALK to RUN 13 LVPC SYMMETRICAL BIPHASIC 6 PENS SPRINT 14 MFAC 7 PENS SKATE 15 HVPC 8 PENS Jump ...

Page 63: ... 60 min 15 min IFC PREMOD Sensory This program is used for symptomatic relief of superficial and deep pain from localized dermatome or segmental origin Duration of relief is typically several hours Fast onset of relief usually happens within 15 20 minutes Target tissue is superficial and deep Bilateral Bipolar or Quadripolar application through the painful area or over the involved spinal segments...

Page 64: ...TION ON N RATE SCAN TIME 0 20 s 4 s Y TREATMENT TIME 0 60 min 15 min IFC PREMOD Sensory Motor Provides symptomatic relief of superficial and deep pain and pain of local generalized single or multi segmental nature Combines sensory and motor stimulation Starts with sensory and ends with motor Duration of relief is typically from 2 to 6 hours Slower onset of relief usually within 15 to 30 minutes Ta...

Page 65: ...uperficial and deep pain and pain of generalized or multi segmental nature Duration of relief is typically from 2 to 8 hours Slow onset of relief usually within 15 minutes to 1 hour Target tissue is superficial and deep Bipolar placement over local and distal trigger points Quadripolar placement over area of local pain or at involved spinal segment The intensity should be set to elicit a moderate ...

Page 66: ...E 4 s Y TREATMENT TIME 0 60 min 15 min IFC PREMOD Motor Sensory Provides symptomatic relief of superficial and deep pain and pain of local generalized single or multi segmental nature Combines motor and sensory stimulation Starts with motor and ends with sensory Duration of relief is typically from 2 to 8 hours Slower onset of relief usually within 15 to 30 minutes Target tissue is superficial and...

Page 67: ...RST FREQUENCY 2 0 Hz N BURST RATE SCAN 50 N RATE SCAN ON N RATE SCAN TIME 15 s Y VECTOR Slow 45 Fast 45 Slow 90 Fast 90 OFF OFF Y TREATMENT TIME 0 60 min 15 min IFC Motor Sensory Subprogram 3 User Adjustable Parameter Y N Parameter Name Adjustable Range unit Default unit N CARRIER FREQ 5 0 kHz N BURST FREQUENCY 100 0 Hz N BURST RATE SCAN 20 N RATE SCAN ON N RATE SCAN TIME 15 s Y VECTOR Slow 45 Fas...

Page 68: ...peated throughout the program until the time runs out The amplitude does not change when the sequence shifts in the protocol Adjustable Parameters Adjustable Parameter Y N Parameter Name Adjustable Range unit Default unit Y VECTOR Off Slow 45 Fast 45 Slow 90 Fast 90 Off Y TREATMENT TIME 0 60 min 15 min Note Total treatment time on the timer is set at 15 minutes At the end of treatment timer the ou...

Page 69: ...egmental origin Blocks pain by causing a temporary nerve block through reactive depolarization Conduction block of the pain signal on its way to the spinal input Also known as Wedensky inhibition Duration of relief is typically from 1 to 2 hours Faster onset of relief usually within 5 to 10 minutes Target tissue is superficial and deep Bipolar placement over local nerve Quadripolar placement over ...

Page 70: ...g piano playing swimming upper extremity positioning speed walking rowing etc Patterned Electrical Neuromuscular Stimulation PENS is a precise reproduction of EMG firing patterns of muscle agonist and antagonist pairs PENS should be used prior to Therex to improve recruitment and motor performance It s also used to decrease spasticity and muscle tone User Adjustable Parameter Y N Parameter Name Ad...

Page 71: ...onist muscle to slow down the antagonist and position the joint Patterned Electrical Neuromuscular Stimulation PENS is a precise reproduction of EMG firing patterns of muscle agonist and antagonist pairs PENS should be used prior to Therex to improve recruitment and motor performance It s also used to decrease spasticity and muscle tone User Adjustable Parameter Y N Parameter Name Adjustable Range...

Page 72: ... to Therex to improve recruitment and motor performance It s also used to decrease spasticity and muscle tone User Adjustable Parameter Y N Parameter Name Adjustable Range unit Default unit Y PHASE DURATION 40 100 μs 70 μs N PULSE RATE 50 Hz Y TREATMENT TIME 0 60 min 15 min N PATTERN Tri Phasic TENS LVPC MOTOR This program motor level stimulation provides neuromuscular stimulation to begin treatme...

Page 73: ...scle The intensity should be set to elicit a grade 2 to 4 muscle contraction Treatment time should be reduced based on muscle fatigue The affected joint movement should be restricted by holding manually or using weights or exercise bands User Adjustable Parameter Y N Parameter Name Adjustable Range unit Default unit Y CARRIER FREQ 2 0 10 0 kHz 2 5 kHz Y BURST FREQUENCY 0 0 200 Hz 75 Hz N BURST RAT...

Page 74: ...ame Adjustable Range unit Default unit Y PHASE DURATION 40 400 μs 70 μs Y PULSE RATE 0 0 200 Hz 50 0 Hz N MODULATION OFF N RATE SCAN TIME 0 s Y TREATMENT TIME 0 60 min 10 min Y 2 B OUTPUT DELAY 0 0 9 9 s 0 0 s Y RAMP UP 0 0 9 9 s 2 0 s Y RAMP DOWN 0 0 9 9 s 2 0 s Y T ON 0 60 s 10 s 1 Y T OFF 0 120 s 50 s 1 Y CHANNEL MODE A B SIMULTANEOUS A B ALTERNATE B DELAYED A B SIM 1 When T OFF 0 T ON CONTINUO...

Page 75: ...le activation in reciprocal patterns for neuromuscular rehabilitation or sports specific training It stimulates 3 short sprint starts followed by a series of 10 simulated 100 meter sprints approximately with 30 seconds of rest between sprints Intensity progress from muscle twitch to full intensity simulating sprint practice Adjust amplitude during the treatment in response to the electrical stimul...

Page 76: ...nd as needed User Adjustable Parameter Y N Parameter Name Adjustable Range unit Default unit Y PHASE DURATION 40 100 μs 70 μs Y CYCLE TIME 5 6 sec 1 3 s N PULSE RATE 100 50 Hz 50 Hz Y TREATMENT TIME 0 60 min 15 min PENS JUMP This protocol simulates jumping and provides aggressive neuromuscular re education of the lower extremities Positioning Standing with both knees slightly flexed Instruct the a...

Page 77: ...itation or sport specific training Intensity Moderate to strong muscle twitch with active contraction Adjust amplitude during the treatment in response to the electrical stimulation when and as needed Baseball patient position Place the patient in sitting with the arm supported in 90 degrees of abduction 90 degrees of elbow flexion and 45 degrees of external rotation Have patient hold a baseball o...

Page 78: ... FREQ 2 0 2 5 4 0 5 0 10 0 kHz 2 5 kHz Y BURST FREQUENCY 0 0 250 Hz 50 Hz N BURST RATE SCAN 20 N RATE SCAN ON N RATE SCAN TIME 4 s Y TREATMENT TIME 0 60 min 15 min N CHANNEL MODE A B SIM MFAC LVPC HAND CONTROL SEQUENCED Program provides for active assisted treatment to develop functional movement of superficial muscle Activation of muscle with electrical stimulation during functional movement The ...

Page 79: ... comfortable muscle contractions Adjust amplitude during the treatment in response to the electrical stimulation when and as needed MFAC Muscle Pump Increases venous and lymphatic circulation via electrical stimulation induced muscle contractions which act as a pump and compress fluids into the venous and lymphatic systems The Off Time default is 4 secs Change the On Time from 4 secs to 12 secs wi...

Page 80: ...nit Default unit N CARRIER FREQ 5 0 kHz Y VECTOR Off Slow 45 Fast 45 Slow 90 Fast 90 Off Y TREATMENT TIME 0 60 min 15 min MFAC RECIPROCAL INHIBITION This program provides for stimulation of the spastic muscle s antagonists It activates reciprocal inhibition of the spastic muscle reducing tone Slow ramps decrease the potential to trigger spasticity of the agonist A single channel A or B is used ove...

Page 81: ... 10 s Y T OFF 0 120 s 10 s Increase Range of Motion ROM MFAC INCREASE ROM Program used for stimulation of range of motion through muscle activation of the agonist or agonist antagonist muscle pairs Activation of muscle with electrical stimulation at a moderate intensity for a longer time Endurance protocol with longer ON OFF ramps improves range of motion The patient should participate to the exte...

Page 82: ...ary nerve membrane depolarization while present This effect is known as Wedensky Inhibition or nerve block Medium frequency currents have an inhibitory effect on pain transmission and sensation within the field of treatment This effect is responsible for the decreased sensation under the stimulation electrodes Medium frequencies are also selected due to their excellent tissue penetration This occu...

Page 83: ...d interferential current therapy may be described as follows a Stimulation of deep and surface tissues b May be used to produce deep and surface analgesia via nerve block Wedensky Inhibition when MF mode is used Vector Technique In order to move the position of the deep interferential fields researchers developed systems to alter the relative amplitudes between stimulation channels in interferenti...

Page 84: ...Procedures Gradually increase intensity to maximum patient tolerance during each contraction Place electrodes in a Monopolar Bipolar or Quadripolar pattern on the muscles in spasm The treatment time should be of approximately 20 minutes duration repeated 2 or 3 times per week Increased Blood Flow Long and short term electrical stimulation of muscle has been shown to alter the vascular dynamics aff...

Page 85: ...lerate The very short pulse duration followed by a very long interpulse interval eliminates the formation of any appreciable chemical or thermal effects in the tissue High voltage Pulsed Current is used for stimulating nerves and muscles causing muscle contractions Examples for clinical use are to treat acute or chronic pain and increase circulation Muscle contraction or motor response of isolated...

Page 86: ...f the cycles with in the burst Burst Frequency expressed in Hertz Hz the current is delivered in packages or Burst of sinusoidal waves it is analogous to the pulse rate in the LVPC Burst Rate Scan expressed as a percentage sets the burst frequency upper and lower limit range for Burst Rate Modulation Rate Scan Time refers to the time elapsed to cycle through the burst frequency modulation range ...

Page 87: ...tivity occurs Pulse duration is the time from all the phases of a pulse and interphase interval expressed in sec Interpulse interval the time between two successive pulses Pulse Frequency expressed in Hz or pps pulses per second defines the repetition rate of the biphasic pulses Phase Duration Modulation expressed in percentage defines a variable phase duration range that can be swept between the ...

Page 88: ... condition Post Traumatic Post Surgical Pain Acute Muscle Tone Spasm This sub thermal protocol is used to reduce pain increase circulation and decrease muscle hypertonicity in the superficial tissues using 3 MHz or deeper tissues using 1 MHz Apply the US over an area that is twice the Transducer size for five minutes Three areas would provide a 15 minute treatment Adjustable Parameter Y N Paramete...

Page 89: ...1 or 3 MHz 3 MHz Y DELTA T 1 2 4 O C 2 O C N TRANSDUCER SIZE 5 cm2 5 cm2 Y TREATMENT TIME 0 60 min Based on Delta T Selection Decrease Joint Stiffness Contracture Heating followed immediately by stretch has been demonstrated to create an increase in the elongation of collagen tissues A 2 4o T change is capable of providing a temperature in tissue capable of reaching the viscoelastic temperature of...

Page 90: ...mulates vasodilation increasing local circulation Application of negative polarity over the edematous site has been demonstrated to reduce post traumatic edema in clinical trials In addition if pain is present can reduce it via segmental pain modulation mechanisms Therapeutic ultrasound can resolve post traumatic edema reduce pain and facilitate tissue healing Duration of relief is typically for s...

Page 91: ...e pain and facilitate tissue healing This program is used for symptomatic relief of superficial and deep pain from localized dermatome or segmental origin Duration of relief is typically for several hours Fast onset of relief usually happens within 15 20 minutes Target tissue is superficial and deep Application Monopolar using Ch B place the red positive electrode adjacent to the treatment area Th...

Page 92: ...ram is used for symptomatic relief of superficial and deep pain and pain of generalized or multi segmental nature Duration of relief is typically for up to 8 hours Slow onset of relief usually within 15 minutes to 1 hour Target tissue is superficial and deep Application Monopolar using Ch B place the red positive electrode adjacent to the treatment area The intensity should be set to elicit a musc...

Page 93: ...ange power button is in the ON position Verify if the AC outlet is functional Verify if the power plug used is appropriate and undamaged see below Inspect Power Supply operation per procedure below Battery Warning Messages Warning messages Recharge batteries for future use Batteries should be charged 8 hours prior to use Insufficient Power Warning Connect to AC outlet Recharge batteries Low Batter...

Page 94: ...equate conductive medium Remove electrode s and replace if necessary Check that the channel output on the display is zero prior to removing electrodes After pressing PAUSE do not remove electrodes for 3 seconds to allow any remaining capacitance to dissipate Patient cannot detect output Failure of lead wire s electrode s Non conductive or poorly conductive electrodes Failure of the stimulator Test...

Page 95: ...response will be present in any channel that is open and is not testing a lead wire Bifurcated lead wire 4 electrodes 1 Insert the lead wire in either channel A or B 2 From the bifurcation divide the four lead wires into 2 red black pairs 3 Connect the ends of just one pair using 2 self adhesive electrodes together gel to gel 4 Press the START button and observe the PASS green FAIL red indication ...

Page 96: ...y rare occurrence a manual optimization option exists in the maintenance section of system settings Select Optimize US Applicator C or Optimize US Applicator D depending on into which channel the replacement transducer has been inserted the Optimize US Applicator screen will appear Pressing Ok at the top of the screen will initiate the optimization process which only takes a few minutes While the ...

Page 97: ...ining your Favorites to the remote control connection 3 Read and obey the warnings and cautions mentioned on page 12 Go to Systems Settings Maintenance and select Restore Favorites If an error occurs during the restore operation i e no favorites found this will be displayed in a pop up message Touch the OK button when the operation is complete Detach the USB stick ACP SERVICE CENTER For repair or ...

Page 98: ...hasic asymmetrical or symmetrical square wave LVPC or mono phasic pulsed current HVPC mode Output Amplitude IFC 0 to 100 mA RMS current into a 500Ω LVPC mode 140mA P P HVPC mode 225VDC peak into 500Ω loads Channel Isolation Independent transformer isolation Line Leakage 50 µA on line power MFAC MEDIUM FREQUENCY ALTERNATING CURRENT MODE Output Waveform 0 100 mA peak 500 Ω load square wave into resi...

Page 99: ...g In alternating mode channels follow each other sequentially In simultaneous modes the output is simultaneous In delayed mode channel B is delayed TIMING SELECTIONS Ramp Time Adjustable from 0 to 9 seconds in 1 second increments Ramps overlap in NMES Alt mode or with channel delay ON Time Adjustable from 1 to 60 seconds in 1 second increments OFF Time Adjustable from 0 continuous to 120 seconds i...

Page 100: ...nufacturer s declaration Electromagnetic Immunity The OmniVersa is intended for use in the electromagnetic environment specified below The customer or the user of the OmniVersa should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD to IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8...

Page 101: ...smitters should be less than the compliance level at all frequencies Interference may occur in the vicinity of OmniVersa which is marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range is applicable NOTE 2 These guidelines may not be applicable in all cases Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Th...

Page 102: ...1 2 2 100 12 3 5 7 For transmitters rated at a maximum output which is not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the respective column whereby P is the maximum rated output of the transmitter in Watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the higher frequency range is applicable NOTE 2 Th...

Page 103: ... Offers 2 channels of programmable stimulation with MFAC Russian style NMES Low Volt Pulsed Current LVPC High Volt HVPC Standard and or Optional Accessories ITEM ITEM NO DESCRIPTION 69631 Remote Control 19987 Remote Patient Stop 19856 OmniVersa Power Cord A C Hospital Grade 11486 OmniVersa FX2 Professional User Manual 67652 OmniVersa Leatherette Soft Carry Case This item is an optional accessory a...

Page 104: ...stim Electrode 2ea pkg 10pkg bx Infection Control Supplies ITEM ITEM NO DESCRIPTION 52479 Barrier Film for Surfaces Infection Control 4 x 6 perforated sheets 1200 sheets roll 66431 Barrier Film for Surfaces Infection Control 6 x 9 perforated Sheets 1200 sheets roll 50593 Barrier Film for Surfaces Infection Control 12 x 14 perforated Sheets 800 sheets roll 30355 Sheath US Transducer covers 3 x 12 2...

Page 105: ...will be void if any of the following have occurred 1 The product contains repairs or replacement parts not furnished by ACP 2 The product is damaged resulting from misuse or negligence 3 The product has been tampered with and or altered including serial number alteration Note Use of the Equipment with accessories and or supplies not approved by ACPL for use with the Equipment may void the warranty...

Page 106: ...r damage to the Equipment prior to receipt at the ACP Service Center Equipment returned for warranty service must be shipped complete with all accessories except for manuals in its original packing or equivalent so as not to be damaged while in transit Note Any Equipment sent to the ACP Service Center that is not covered by the ACP Limited Product Warranty is subject to a minimum service and handl...