ACP Omnistim 500A User manual

OMNISTIM

Electrotherapy System

User Manual

This Manual contains confidential and proprietary information owned by Accelerated Care Plus ("ACP") which is protected by copyright. This Manual or any portion thereof may not be photocopied, reproduced or translated to another language without the express prior written consent of ACP. This Manual may only be used by entities who have purchased the equipment or have implemented the ACP program and are covered by an executed Lease Agreement with ACP containing a Confidentiality Agreement, which is incorporated by reference in its entirety. This Manual may not 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 WARRANTY OF ANY KIND WITH REGARD TO THIS MANUAL, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. Accelerated Care Plus shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance or use of this Manual.

The information contained in this document is subject to change without notice.

500A

Revised 070101

Part No. 290500A

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2 OMNISTIM

500A USER MANUAL

OMNISTIM® 500A

ACP manufactures a premier line of electromedical devices to assist health care professionals in the rehabilitation of their patients. The ACP product line includes Pain Control Systems, Muscle Stimulators, Interferential Therapy, and

Ultrasound devices. Our MEGAPULSE

most recent world wide technological advances available for therapeutic application of electromedical devices.

ACP is internationally recognized for its contribution to research in the development of medical applications for therapeutic rehabilitation. The Company sponsors and conducts research at leading health care institutions and major universities throughout the world. This new medical frontier holds great promise and opportunity, which will result in substantial advancements in the health care industry and for ACP.

, NEUROPROBE®, OMNISTIM®, and OMNISOUND

represent the

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OMNISTIM® 500A USER MANUAL 3

TABLE OF CONTENTS

INDICATIONS & CONTRAINDICATIONS ..............................................................................................................4

Indications...........................................................................................................................................................4

Contraindications................................................................................................................................................4

Adverse Reactions ..............................................................................................................................................4

WARNINGS & PRECAUTIONS .................................................................................................................................5

Warnings.............................................................................................................................................................5

Precautions..........................................................................................................................................................6

THE OMNISTIM® 500 .................................................................................................................................................8

Delivery of the OMNISTIM® 500 ......................................................................................................................8

Introduction.........................................................................................................................................................8

Controls and Functions .......................................................................................................................................9

Factory Settings ................................................................................................................................................10

Battery Charger / Power Supply Operation ......................................................................................................11

Operational Sequence .......................................................................................................................................12

TREATMENT GUIDELINES ....................................................................................................................................13

Introduction to Medium Frequency Currents....................................................................................................13

Electrode Application Techniques....................................................................................................................14

Treatment Preparation.......................................................................................................................................16

INFECTION CONTROL EQUIPMENT AND PRINCIPLES OF USE.....................................................................17

Definitions ........................................................................................................................................................17

Universal Precautions – Body Substance Isolation...........................................................................................17

Cleaning/Disinfecting of the OMNISTIM® 500 ...............................................................................................17

Cleaning, Low Level Disinfection and Barriers................................................................................................17

Intermediate Level Disinfection........................................................................................................................17

Use of Barriers – Intermediate Level Disinfection ...........................................................................................18

MODES OF OPERATON: Protocol Reference Sheets...............................................................................................19

Interferential Current (IFC)...............................................................................................................................19

Medium Frequency Alternating Current (MFAC)............................................................................................20

Low Volt Pulsed Current (LVPC) ....................................................................................................................21

High Volt Pulsed Current (HVPC) ...................................................................................................................22

STIMULATION THERAPY MODES........................................................................................................................23

Interferential Current Therapy (IFC) ................................................................................................................23

Medium Frequency Alternating Current (MFAC)............................................................................................30

Low Volt Pulsed Current (LVPC) ....................................................................................................................35

High Volt Pulsed Current HVPC......................................................................................................................39

TROUBLESHOOTING ..............................................................................................................................................41

Service Center...................................................................................................................................................43

TECHNICAL SPECIFICATIONS..............................................................................................................................44

OMNISTIM® 500 STANDARD AND OPTIONAL ACCESSORIES .......................................................................46

Electrodes .........................................................................................................................................................47

Infection Control Supplies ................................................................................................................................47

LIMITED PRODUCT WARRANTY .........................................................................................................................48

Warranty Coverage...........................................................................................................................................48

Warranty Exclusion ..........................................................................................................................................48

Warranty Period................................................................................................................................................48

Warranty Validation .........................................................................................................................................48

Return of Defective Products............................................................................................................................49

APPENDIX - ILLUSTRATED OPERATIONAL SEQUENCE.................................................................................51

Procedure for Quick Start-Up ...........................................................................................................................51

Detailed Operational Sequence.........................................................................................................................53

Adjusting Global Factory Settings....................................................................................................................59

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500A USER MANUAL

INDICATIONS & CONTRAINDICATIONS

CAUTION: Federal law restricts this device for sale or use by, or on the order of, a Practitioner

licensed by the laws of the state in which he/she practices to use or order the use of the device. Please note that Accelerated Care Plus cannot provide medical advice. If you have specific

medical questions, please contact your healthcare professional.

Indications

The OMNISTIM

1. Symptomatic relief and management of chronic intractable pain and as an adjunctive treatment in the

management of acute pain, post surgical pain and pain associated with post-traumatic injury.

2. Relaxation of muscle spasms.

3. Re-education of muscle action.

4. Prevention or retardation of disuse atrophy.

5. Immediate post surgical stimulation of calf muscles to prevent venous thrombosis.

6. Increased local blood circulation.

500 is indicated for:

7. Maintaining or increasing range of motion.

Electrical muscle stimulator devices should be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

Contraindications

1. Transcutaneous electrical stimulation, or powered muscle stimulators should not be used on patients with

cardiac demand pacemakers and/or implanted defibrillators.

2. Never connect lead wires to the power line or electro-surgery equipment. Use only the lead wires

recommended or approved by the manufacturer.

NOTE: There is no contraindication to the application of Transcutaneous Electrical Stimulation or Powered Muscle Stimulation over metal implants.

Adverse Reactions

Skin irritation and burns beneath the electrodes have been reported with the use of powered muscle stimulators.

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OMNISTIM® 500A USER MANUAL 5

WARNINGS & PRECAUTIONS

CAUTION: Federal law restricts this device for sale or use by, or on the order of, a Practitioner

licensed by the laws of the state in which he/she practices to use or order the use of the device. Please note that Accelerated Care Plus cannot provide medical advice. If you have specific

medical questions, please contact your healthcare professional.

Warnings

• Do not operate this device until the User Manual, including all Indications for Use, Contraindications, Warnings

and Precautions, have been carefully read and understood.

• Operation of this device or placement of lead wires, probes, pads and electrodes in close proximity (less than 5

feet) to an operating shortwave or microwave diathermy unit may produce instability in the device output or burns at the treatment site. Lead wires and device can pick up the magnetic field output of the diathermy and through 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 be applied over the carotid sinus nerves, (located in the anterior neck triangle), including,

stellete ganglion, vagus nerve, or laryngeal or pharyngeal muscle. Particular care should be taken for patients with a known sensitivity to the carotid sinus reflex, as carotid sinus stimulation may alter blood pressure and cardiac contractility.

• Do not apply treatment over testes, heart or eyes. Thermal effects or electrical stimulation may affect organ

function.

• Do not apply over or in close proximity to active cancer (except in terminal / palliative / hospice care), as

therapy may increase blood flow to the tumor.

• Treatment should not be applied when high fever is present, over swollen, severe infection, (osteomyelitis,

sepsis, tuberculosis, etc.), or inflamed areas or skin eruptions, (e.g., phlebitis, thrombophlebitis, varicose veins, etc.).

• Do not apply over the lumbar or abdominal region, or over the uterus during pregnancy (to prevent uterine

contraction), or during menstruation as therapy may temporarily increase menstrual flow.

• The long-term effects of chronic electrical stimulation are unknown. To date, the only negative effects reported

are based on skin and tissue irritation under the electrode sites associated with chronic estim use.

• Stimulation should not be applied transthoracically in the vicinity of the heart, as introduction of electrical

current into the heart may cause cardiac arrhythmias.

• Treatment should not be applied transcranially.

• Stimulation should not be applied to patients connected to patient monitoring equipment, as the stimulation may

have an affect on the proper operation of the monitoring equipment.

• Stimulation should not be applied directly over external or implanted stimulator systems, such as shunts,

infusion pumps, stomach, bladder, brain, spinal cord, bone growth, or other implanted stimulators.

• Neuromuscular electrical stimulation (NMES) should not be applied directly over or in close proximity to Deep

Vein Thrombosis (DVT), as it activates the muscle and causes muscle contractions. This should be avoided in tissue following an acute DVT when the thrombosis is not completely resolved. Therapists should follow the guidelines provided by the referring physician on recommended activity level and modality use. If the patient is not permitted exercise, NMES therapy should be avoided. Generally, NMES over a DVT of six weeks or less should be avoided altogether.

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500A USER MANUAL

Precautions

• Application site and settings should be based on the guidance of the prescribing practitioner.

• All equipment and accessories should be kept out of the reach of children or unqualified persons.

• Do not connect this device to any wall outlet that has not been properly grounded, or to any electrically non-

isolated medical device.

• Use only ACP specified accessories and/or supplies with ACP devices. Do not use any power cords, or power

supplies, other than the ones provided or specified for this device. Use of any other power supply could seriously damage the device and will void the warranty.

• When cleaning the device, never immerse them or wash them with water. See the Infection Control section in

this manual for cleaning instructions. Devices should not be submerged in water or other liquids.

• Failure to follow the manufacturer’s prescribed maintenance for this device may lead to device failure and

transient or unreliable performance. State and federal survey and JCAHO require all equipment to be maintained and calibrated according to the manufacturer recommended schedules.

• A potential electric shock hazard exists once the device 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.

• Do not apply over areas of hemorrhage or active bleeding. Modalities should be applied following cessation of

hemorrhage or active bleeding as they may promote increased circulation and inhibit coagulation.

• Inspect and cleanse the skin prior to application. Following treatment check the skin for evidence of irritation

or burns, and if present, treat as appropriate. If the patient has, or complains of, skin irritation following treatment, shorten the treatment time on the next treatment session, or use an alternative type of therapy or electrode placement.

• Gradually increase the output intensity/power to required dose or patient tolerance while monitoring the device

display.

• Caution should be taken with patient exhibiting psychological or physical hypersensitivity to the therapeutic

treatment. Several 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 during treatment, adjust the output downward until it is tolerated by the patient. If the patient continues to complain of pain, discontinue the treatment and shorten the treatment time on the next treatment session, or use an alternative type of therapy or electrode placement.

• Do not apply treatment directly over/under hot or cold packs. Caution is recommended when treatment follows

the application of hot or cold therapy, which may alter the patient’s sensation. Application of thermal agents over areas of impaired circulation should be performed with caution as the circulation may be insufficient to heat or cool the tissue, altering the patient’s perception of warmth and pain, and burns or tissue necrosis may result from subsequent treatment.

• Caution is recommended when treatment follows the application of medicated patches, salves, or creams which

may alter the patient’s sensation. If there is a medical necessity to perform such treatments, these patients should be monitored diligently during application. The presence of electrical stimulation may be altered by the presence of these materials on the patient’s skin.

• Caution should be used over areas of body where circulation is impaired, or which lack normal sensation.

Absent or diminished sensation should be avoided or, if unavoidable, treated with caution. Establishment of acceptable intensity levels for desensitized areas may be related to the intensity levels tolerated on normal skin in opposite or related body parts.

• Caution should be used in the presence of recent surgical procedures, fractures or healing bone and soft tissue

when muscle contraction may disrupt the healing process.

• Caution should be used for persons with suspected or diagnosed heart problems.

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OMNISTIM® 500A USER MANUAL 7

• Caution should be used for patients with suspected or diagnosed epilepsy.

• 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 lead to high energy density and skin burns under or between the electrodes.

• Care should be used when removing electrodes after treatment, in order to minimize the potential for skin

tearing. Skin should be inspected after removal of electrodes for any signs of tearing or irritation.

• Do not connect the stimulator to any electrical equipment for combination therapy except the Omnisound

family of ultrasounds.

• ACP does not recommend the use of the Denervated Muscle or Low Intensity DC protocols, and does not

supply the DC or Microcurrent adapter required for use with these protocols. If this device is used with a DC or Microcurrent adapter, follow the specific treatment guidelines, indications, contraindication, warning and precautions specified in the DC or Microcurrent adapter manual. Do not use any protocols requiring the use of the DC or Microcurrent adapter without first having plugged the adapter into the appropriate channel.

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8 OMNISTIM

500A USER MANUAL

THE OMNISTIM® 500

Delivery of the OMNISTIM® 500

Upon receipt of your OMNISTIM

damage. All ACP products are packaged carefully for rapid, safe delivery. We guarantee delivery in perfect condition to the postal or delivery services. However any damage or loss incurred during transportation or delivery is the Postal or Delivery Company’s responsibility. If damage or loss to the product and/or container is obvious or suspected, appropriate notation must be made on the signed freight bill at the time of delivery. All damage claims should be promptly filed with the delivering carrier and must be initiated by the addressee where the package was to be delivered. Retain the original shipping container and inserts for validation of damage claim or use at a later date.

Unpack and check all accessories. A list of enclosed accessories is provided with each unit to assist you in identification of the type and number of accessories.

NOTE: The purpose of this manual is to acquaint you with the OMNISTIM® 500’s operating features and functionality. Please read the manual carefully before attempting to operate the OMNISTIM remain unanswered, contact your ACP sales representative or call 1-800-350-1100. Outside the USA call 1-775685-4000.

500, inspect the shipping container and contents for any obvious or concealed

500. If questions

Introduction

The OMNISTIM

Currents (MFAC), Low Voltage Pulsed Current (LVPC) and High Voltage Pulsed Current Therapy (HVPC). Its two separate generators produce medium frequency (2000, 2500, 4000 or 5000 Hz) alternating current in continuous or modulated modes. Two isolated output circuits with independent intensity controls are provided. The output of each circuit is easily determined in milliamps through the display screen. The digital timer allows the operator to select the length of the total treatment time and to monitor the time remaining in minutes.

The OMNISTIM

interferential vector scanning mode can be turned off or on for stationary or continuous movement of the interferential field.

The OMNISTIM

provides a wide variety of uses for muscle re-education and muscle spasm reduction protocols for innervated muscle.

The OMNISTIM

operation with fully adjustable ON and OFF times and ramps allow applications of HVPC therapy. Increasing circulation, pain control and muscle re-ed can be set up in this mode.

500 is designed to provide Interferential Current Therapy (IFC), Medium Frequency Alternating

500 offers Frequency Difference (FD) and Full Field (FF) Interferential Current Therapy. An

500 MFAC and LVPC modes with fully adjustable ON and OFF times and ON and OFF ramps

500 provides High Voltage Pulsed Current (HVPC) on one channel. Continuous or surged

CONFIDENTIAL AND PROPRIETARY

OMNISTIM® 500A USER MANUAL 9

Controls and Functions

A. Main power switch. Press for power ON, press again for power OFF. The display illuminates with SELECT

MODALITY/PROGRAM.

B. Parameter select button provides adjustment of stimulation parameters, screen contrast, audio on/off and button

speed and sensitivity. Press to enter SETECT mode. It is possible to adjust most stimulation parameters at any time during treatment.

C. START/STOP Set output button. Having selected the type of treatment and program press to set the output or

start or stop the treatment. START/STOP also cancels the SET mode.

D. Increase/Decrease OUTPUT A. Press rocker switch to the right to increase output current. Press to the left to

decrease output current.

E. Increase/Decrease OUTPUT B. Press rocker switch to the right to increase output current. Press to the left to

decrease output current.

F. Increase/Decrease Beat frequency or TIME OFF Press rocker switch to the right to increase the duration of the

TIME OFF period; press to the left to decrease the duration of the TIME OFF period during MFAC, LVPC or HVPC modes. Press rocker switch to the right to increase BEAT (or base) frequency; press to the left to decrease BEAT frequency during INTERFERENTIAL modes.

G. Increase/decrease SWEEP frequency or TIME ON. Press rocker switch to the right to increase duration of

TIME ON period; press to the left to decrease the duration of the TIME ON period during MFAC, LVPC or HVPC modes. Press rocker switch to the right to increase SWEEP (or spectrum) frequency; press to the left to decrease SWEEP frequency during INTERFERENTIAL mode.

H. Timer/parameter switch. Increases/decreases treatment time or changes parameters in set mode. I. Select single channel HVPC protocol when pressed. J. Selects LVPC protocol when pressed. K. Selects MFAC (Russian style stimulation) protocol when pressed. L. Select Interferential (IFC) protocol mode. M. Patient Safety Input Switch N. Charging/line operation indicator LED. O. Battery charger input jack. P. Output for HVPC.

CONFIDENTIAL AND PROPRIETARY

10 OMNISTIM

500A USER MANUAL

Q. Output for channel “B” in IFC, MFAC and LVPC modes. R. Output for channel “A” in IFC, MFAC and LVPC modes. S. Lead wire adapter – 3 pin. T. Super twist LCD graphics display for all functions and parameters. The graphics screen allows display of:

• Modality selected

• Program selected

• Time remaining

• Bar graph for timing

• On-Off time, delay and ramps

• Beat frequency and sweep ranges

• Sweep rate and modulation selection

• Burst or pulse frequency

• Phase duration and interphase interval

• Output voltage or current

• Vector selection

• Battery condition

• Display contrast

• Button speeds and delay

Factory Settings

The OMNISTIM

These are generally suitable for most clinicians. To adjust these default settings proceed as follows:

1. When the main screen comes up and states “SELECT MODALITY/PROGRAM” push the SELECT

PARAMETERS button repeatedly to display the factory settings. You will then be able to adjust the selected factory settings by pressing the TIME/PARAMETER up/down button. The new settings will be saved from use to use as long as you do not remove the batteries or allow a full discharge of the unit.

500 comes with the following factory settings:

Button Speed, A & B Output 87 Button Speed, Beat, etc. 93 Button Delay, all 40 Audio ON Screen Contrast 5

2. The screen contrast sets the appropriate viewing angle for easy screen legibility.

3. The button speed for output A & B sets the speed at which output will increase and decrease when you

push the buttons. This should generally be set at a slower speed (80 - 90) so as not to startle the patient.

4. The Button speed BEAT Etc. controls the scrolling speed of all of the remaining buttons on the system. A

speed of 90 to 95 is typical if you have good coordination and hand control.

5. The button delay represents the amount of time that you have to push and hold the buttons down before

they will begin to increment automatically at the button speed. The smaller the number the faster the response time.

6. Audio on or off disables or enables the audio system that beeps at the end of the treatment and during the

NMES programs.

NOTE: The factory settings cannot be accessed during operation and are only available following the start up screen. The settings will reset to their initial d efault parameters if the ba tteries are removed or the unit is fully discharged. To restore the new settings follow the procedure in Appendix I.

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OMNISTIM® 500A USER MANUAL 11

Battery Charger / Power Supply Operation

Before using the OMNISTIM

1. Verify that rechargeable batteries are installed within the OMNISTIM

2. Check to see that the battery type selector switch located inside the battery compartment has been switched

to the rechargeable position.

If you plug in the charger, after two seconds, the charge LED on the OMNISTIM

batteries are fully charged, the LED blinks. If you plug in the charger during treatment or when the unit is ON the LED turns off. (The charging continues but at a trickle and does not cause the LED to glow.) When you turn OFF the unit after two seconds the LED comes on to announce charging.

NOTE: If non-rechargeable batteries are used:

1. Do not use the charger.

2. Make sure that the rechargeable/non-rechargeable selector switch in the bottom of the battery

compartment is in the non-rechargeable position.

Life expectancies of batteries under nominal (20 mA IFC, 40 mA MFAC, 100v HVPC) load conditions:

• 4.4Ah NiCad rechargeable batteries - 10 Hours.

• Alkaline non-rechargeable batteries - 100 Hours.

500 battery charger/power supply:

500 battery compartment.

500 is illuminated. After the

CONFIDENTIAL AND PROPRIETARY

12 OMNISTIM

Operational Sequence

SET OUTPUT A/B A:00 mA B:00 mA r2.0

500A USER MANUAL

1. Press the ON/OFF button to turn on the power. The display panel will illuminate. There will be no

stimulation current and the unit will be in the SELECT MODALITY/PROGRAM mode.

2. At this time select the treatment modality desired and the appropriate treatment protocol by using the

modality buttons (2) to select HVPC, LVPC, MFAC or IFC protocols.

3. Now position the electrodes on the patient, connect the electrode plug(s) and press the START/STOP

button (3/5). The program parameters will disappear and be replaced with the screen seen above.

The bar graph on the lower right of the display shows the relative outputs of the two channels primarily with respect to Time On and Time Off and Vector operation. The numeric displays on the lower left show the output intensities into a 500-ohm load. Each time a treatment is commenced, the output current level is reset to zero; this ensures that your patient cannot receive an initial shock due to the current output, inadvertently, being left at a high setting from a previous treatment. The patient safety switch is a remote duplicate of the Start/Stop switch and therefore resets the outputs to zero.

4. Adjust output by pressing the up/down (4) for channel A and channel B. Once desired output intensity is

selected, press START/STOP button (3/5) to display timer and to initiate treatment.

5. Press the SELECT PARAMETERS button to modify any settings. Press the MODIFY TIME / PARAM up or

down buttons to adjust the desired treatment time, or other settings, if you wish to change from the default settings. Set the timer for the desired treatment time. Pressing the switch up or down, increases or decreases the duration from a minimum of 1 minute to a maximum of 60 minutes. The timer will count down to zero during treatment; when zero is reached a warning tone is emitted from the unit, the treatment current is switched off and Treatment Off is displayed. Pressing the START/STOP button (3/5) will shut off the warning tone. If the unit is left unattended, the warning tone is emitted for ten seconds before power is automatically switched off. Note that the treatment time is preset for each program but may be adjusted at will during the treatment.

NOTE: When selecting the MFAC or LVPC alternate or delayed modes the system will allow first set up of output A followed by set up of output B. Pushing the START/STOP SET output again will start the u nit timing cycles if applicable in the program.

6. During operation the parameters may be altered within the program at will by selecting the set mode. See

set mode operation and adjustable parameters for each modality.

7. Once the treatment is completed, remove the electrodes from the patient and disconnect the lead wires from

the electrodes.

8. Turn the unit off by pressing the power button.

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OMNISTIM® 500A USER MANUAL 13

TREATMENT GUIDELINES

Introduction to Medium Frequency Currents

Medium frequency (MF) currents may be described as electrical currents applied to the body for therapeutic purposes, which fall in the range of 1000 to 10,000 cycles per second (Hz). This is in contrast to low frequency currents (0.1 to 1000 Hz) such as LVPC, HVPC, and high frequency currents (1 million Hz and beyond), which include ultrasound, shortwave and microwave diathermy. Medium frequency currents are very advantageous for clinical use due to their ease of skin penetration at lower intensities.

Normal human skin reacts differently to different frequencies of current. Specifically, there is an inverse relationship between the frequency of the applied current and the skin’s resistance to it. Medium frequency alternating currents in the range of 1000 or 5000 Hz provide markedly lower resistance to penetration than low frequency electrical stimulation commonly used in TENS, LVPC, and HVPC stimulation. Medium frequency currents can be used in Bipolar or in Quadripolar Interferential mode for patient treatment.

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 process of the intact nervous system. This is not the case with low frequency stimulators (0.1 to 1000Hz), which are capable of only stimulus synchronous neural activation.

Medium frequency currents provide rapid analgesic effects. This occurs due to rapid depolarization of nonmyelinated pain-transmitting fibers, which block pain transmission, further contributing to high muscle contraction capabilities. Additionally, medium frequency currents have been shown to alter the vascular dynamics affecting local and possibly systemic blood flow to the muscle(s) being stimulated. The unique characteristics of medium frequency currents, (higher percent duty cycle, higher average current intensity, and wider pulse widths), can significantly increase blood flow by altering the metabolic activity of muscles.

PLOT IMPEDANCE AS A FUNCTION OF FREQUENCY USING EPIDUCTIVE SYSTEMS

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14 OMNISTIM

500A USER MANUAL

Electrode Application Techniques

The following electrode placement diagrams are a theoretical representation of treatment set-ups using the

OMNISTIM

Electrode placement is dependent on the etiology of the condition.

Monopolar (Mono-Polar) Technique

This technique may use two electrodes of different sizes. The smaller, or “active” electrode can be positioned over the segmental innervation or peripheral nerve path of the involved tissue, or over a distal location overlying any muscle that is not an antagonist to the muscle being stimulated.

500. Monopolar, bipolar and quadripolar techniques are illustrated for various areas of the body.

CERVICAL MONOPOLAR

PLACEMENT OF

ELECTRODES

Bipolar (Bi-Polar) Technique

This is the most commonly 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 furnished with current.

CERVICAL BIPOLAR

PLACEMENT OF

ELECTRODES

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OMNISTIM® 500A USER MANUAL 15

Quadripolar (Quadri-Polar) Technique

This technique requires the use of two output channels and four electrodes usually, but not exclusively of the same size. The two electrodes from one channel are usually placed diagonally across the tissue area or joint to be treated with the second channel electrodes placed on the opposite diagonal. This ensures that the current will intersect and thus provide and interferential pattern.

CERVICAL QUADRIPOLAR

PLACEMENT OF

ELECTRODES

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16 OMNISTIM

500A USER MANUAL

Treatment Preparation

Skin Inspection

Thoroughly cleanse the treated area with soap and water to remove oils, creams, dirt, and sweat; this will ensure uniform current conduction across the skin. After cleansing, inspect and evaluate the skin’s integrity and sensation prior to treatment. Avoid absent or diminished sensation; if unavoidable, treat with caution. Establishment of acceptable intensity levels for desensitized areas may be related to the intensity levels tolerated on normal skin in opposite or related body parts. Frequently monitor the intensity level and skin response during all treatments.

Stinging, burning or other painful sensation under the electrodes on normal or desensitized areas is an indication of increased current density under part or all of the electrode surface. In this case, slowly but immediately reduce the current intensity to zero; remove the electrodes to inspect the surface skin. Recheck your application techniques.

Immediately after treatment, clean and thoroughly inspect the skin under the electrode. Peripheral vasodilation along with systemic vasomotor responses can lead to redness (hyperemia) directly under both electrodes. Inform the patient of this normal after effect and that the redness will disappear within an hour or two. Apply topical agents to the reddened area under the electrodes if needed to decrease post-treatment irritation. Persistent skin irritation could be due to repeated stimulation of the same electrode site or a possible allergic reaction to the conductive mediums, tapes, elastic wraps, and/or cleaning and disinfectant solutions. Therefore, use additional electrode stimulation sites to decrease or eliminate skin irritation on electrically sensitive 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 causes which lead to machines being incorrectly reported as faulty are inadequate or improper conductive medium interface or lead wire breakage. Because of the increased current density available with pulsed or continuous medium frequency currents, a proportionally greater degree of conductive medium interface problems exists and should be monitored by the clinician.

ACP Reusable Electrodes

Remove the electrodes from their foil packaging. Cleanse the skin then apply the electrodes over the treatment site points according to the electrode placements techniques described in this manual. Various sizes of electrodes are available dependent upon muscle size of the area to be treated. Follow the enclosed infection control procedures. Review the warnings and application directions on the electrode packaging.

NOTE: The use of conductive mediums other than specifically approved pre-gelled or self adhering electrodes such as ultrasound gel or lotion, hand or body lotion, electrolyte spray mist, paper towels, non-approved reusable or disposable pre-gelled or self-adhering electrodes—are contraindicated for use with OMNISTIM

Lead Wires

Inspect the full length of the lead wires for signs of frayed or cut wires and loose connections where the lead wires join the stereo jack plug and tip pins. Insert the stereo plug completely. Allow the lead wires to hang freely with no excessive strain on the stereo plug insulator.

Periodically check the lead wires by checking their conductivity with an Ohmmeter. With the lead wire pin tips together, measure the resistance between the tip and ring conductors of the stereo plug. The resistance should measure very near to zero. If the resistance remains near to zero when the pin tips are disconnected from each other, a short exists in the stereo plug insulator; replace the lead wire set.

systems.

CONFIDENTIAL AND PROPRIETARY

OMNISTIM® 500A USER MANUAL 17

INFECTION CONTROL EQUIPMENT AND PRINCIPLES OF USE

Definitions

• Barrier Film – One-time use, disposable plastic film for use over touch/operator surfaces of equipment to

reduce risks of cross-contamination and need for high level disinfection of equipment between patients.

• Germicidal Disposable Wipe – Low level and/or intermediate level disposable germicidal disinfectant

wipe for use on electrotherapeutic devices and accessories.

• Plastic Lead Wire Sleeve – Barrier to be used on electrical stimulation lead wires, covering the junction of

lead wire and electrode wire.

Universal Precautions – Body Substance Isolation

Universal Precautions (UP) must be implemented in the care of all patients to protect employees from occupational exposure to bloodborne pathogens. Personal protective equipment (gloves, masks, gowns) should be available and worn by staff when occupational exposure to blood, body fluids containing blood, semen and vaginal secretions is likely to occur. Health care workers with exudating lesions or weeping dermatitis should refrain from all direct patient care and from handling patient care equipment until the condition resolves. Equipment must be cleaned/disinfected and protective barriers used when appropriate.

Cleaning/Disinfecting of the OMNISTIM® 500

Modality equipment shall be cleaned/disinfected per facility 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 urine.

• Clean equipment daily with ACP germicidal wipes. At the end of the day, wipe common contact surfaces,

such as control panel and lead wires, with germicidal disposable wipe and allow to air dry. This technique

will inactivate M. tuberculosis as well as most bacteria and viruses. This will also facilitate removal of

organic material contaminants from equipment.

• Disposable/reusable electrodes are for individual patient use only and should not be used on multiple patients.

Intermediate Level Disinfection and Barriers

This method is recommended to keep the equipment clean and free of contaminants when used between patients for treatment of non-intact skin or incontinence management, where there is an increased risk of patient crosscontamination. The following are the recommended practices:

• After each use, clean common contact surfaces, such as control panel and lead wires with ACP germicidal

wipes.

• With a second ACP germicidal cloth, wipe again leaving surfaces wet for at least 5 minutes. Allow the

surface to air dry before patient use.

• Barriers should also be used on the equipment for treatment of non-intact skin or incontinence

management. This technique will inactivate M. tuberculosis as well as most bacteria and viruses.

CONFIDENTIAL AND PROPRIETARY

18 OMNISTIM

500A USER MANUAL

Use of Barriers – Intermediate Level Disinfection

The use of an all-purpose barrier film provides surface protection from cross-contamination resulting from a variety of applications. This procedure should be used whenever dealing with non-intact skin or the chance of coming in contact with bodily fluids. Barrier film is designed to cover any surface that may be touched during a patient treatment to help prevent cross-contamination. Barrier film is for single-use only. The film is discarded after each patient treatment. The procedure for use is as follows:

1. Wash hands.

2. Apply intermediate level disinfection prior to barrier application.

3. Select, tear and place a length of barrier film to fit over the

operatory surfaces of the OMNISTIM

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 come in contatct with the therapist during

treatment, such as pens, assessment tools, cart handles, etc.

6. Set up the patient per guidelines for the procedure.

7. Provide treatment as appropriate.

8. Discard all disposables.

9. With clean gloves, remove the plastic film from the OMNISTIM

and discard.

10. Remove the plastic sleeve from the lead wire by sliding it toward the

electrode. Remove the electrode and discard with the sleeve.

11. Intermediate disinfect the OMNISTIM

treatment application.

500 unit.

500 unit prior to the next

500

CONFIDENTIAL AND PROPRIETARY

PROTOCOL / CLINICAL

INDICATION

MODES OF OPERATON: Protocol Reference Sheets

Interferential Current (IFC)

STIMULATION PARAMETERS MECHANISM OF ACTION APPLICATION TECHNIQUE OPERATIONAL SEQUENCE

OMNISTIM

500A USER MANUAL 19

CONFIDENTIAL AND PROPRIETARY

ANALGESIA - SENSORY SEGMENTAL SUB ACUTE

Symptomatic relief of pain from localized dermatome or segmental origin.

ANALGESIA - MOTOR NON - SEGMENTAL CHRONIC

Symptomatic relief of pain with inflammation, and pain of generalized or multi-segmental nature.

ANALGESIA / MOTORSENSORY SUB-ACUTE CHRONIC

Symptomatic relief of pain with inflammation, and pain of local, generalized single or multisegmental nature.

ANALGESIA SENSORYMOTOR ACUTE SUB-ACUTE

Symptomatic relief of pain with Inflammation, pain of local, generalized single or multisegmental nature.

• 5000Hz 80/120 BPS continuous

• Vector Fast 90

• Treatment time of 15 minutes

• 2500Hz – 2/6 BPS continuous

• Vector Fast 90

• Treatment time of 15 minutes

• 5000Hz – 15/2/100 BPS

• Vector Fast 90

• Treatment time of 30 minutes

• 5000Hz – 100/2 BPS continuous

• Vector Fast 90

• Treatment time of 30 minutes

Sensory stimulation activates A-beta fibers causing the release of spinal Enkephalin and Dynorphin to block pain at the segmental level (Gate Control). Duration of relief is typically from 30 min to 2 hrs. Fast onset of relief usually within 20 minutes.

Motor level stimulation activates motor and A-delta fibers causing the release of Bendorphin systemically. Duration of relief is typically from 2-6 hours. Slow Onset of relief usually within 30 minutes to 1 hour

Combines motor and sensory stimulation. Starts with motor and ends with sensory. More aggressive protocol. Duration of relief is typically from 2-6 hours. Slower onset of relief usually within 30 minutes.

Combines sensory and motor stimulation. Starts with sensory and ends with motor. Less aggressive protocol. Duration of relief is typically from 2-6 hours. Faster onset of relief usually within 20 minutes.

Target tissue - superficial and deep. Bilateral, bipolar or quadripolar through the painful area or over the involved spinal segments. Apply parallel to incision line for post op pain management. Set intensity to elicit a pleasant tingling sensation, just below muscle contraction.

Target tissue - superficial and deep. Bipolar placement over local and distal acu / trigger points; quadripolar placement over area of local pain; or quadripolar placement at spinal segment. Set intensity to elicit a moderate muscle twitch.

• Press IFC button until screen reads "ANALGESIA - SENSORY"

• Press START / STOP until screen reads " SET OUTPUTS A-B"

• Set Outputs A and B until the patient feels the desired sensation.

• Press START / STOP and T15 will display in upper right corner.

• Adjust treatment time if necessary using the TIME/PARAMETER button

• The treatment will end at the end of the preset time or if the patient safety

switch is pressed.

• Press IFC button until screen reads "ANALGESIA - MOTOR"

• Press START / STOP until screen reads " SET OUTPUTS A-B"

• Set Outputs A and B until the patient feels the desired sensation.

• Press START / STOP and T15 will display in upper right corner.

• Adjust treatment time if necessary using the TIME/PARAMETER button

• The treatment will end at the end of the preset time or if the patient safety

switch is pressed.

• Press IFC button until screen reads "ANALGESIA/MOTOR - SENSORY"

• Press START / STOP until screen reads " SET OUTPUTS A-B"

• Set Outputs A and B until the patient feels the desired sensation.

• Press START / STOP and T30 will display in upper right corner.

• Adjust treatment time if necessary using the TIME/PARAMETER button

• The treatment will end at the end of the preset time or if the patient safety

switch is pressed.

• Press IFC button until screen reads "ANALGESIA/SENSORY - MOTOR"

• Press START / STOP until screen reads " SET OUTPUTS A-B"

• Set Outputs A and B until the patient feels the desired sensation.

• Press START / STOP and T30 will display in upper right corner.

• Adjust treatment time if necessary using the TIME/PARAMETER button

• The treatment will end at the end of the preset time or if the patient safety

switch is pressed.

ANALGESIA NERVE BLOCK LOCAL ACUTE

Symptomatic relief of pain from localized dermal or segmental origin.

• 5000Hz Continuous

• Vector OFF

• Treatment time of 10 minutes

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 1-2 hours Faster onset of relief usually within 5-10 minutes.

Target tissue - superficial and deep. Bipolar placement over local nerve; quadripolar placement over area of local pain; quadripolar placement at spinal segment. Set intensity to a numb-gripping sensation just under muscle contraction.

• Press IFC button until screen reads "ANALGESIA NERVE BLOCK"

• Press START / STOP until screen reads " SET OUTPUTS A-B"

• Set Outputs A and B until the patient feels the desired sensation.

• Press START / STOP and T10 will display in upper right corner.

• Adjust treatment time if necessary using the TIME/PARAMETER button

• The treatment will end at the end of the preset time or if the patient safety

switch is pressed.

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