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

CONFIDENTIAL AND PROPRIETARY

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

CONFIDENTIAL AND PROPRIETARY

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

CONFIDENTIAL AND PROPRIETARY

4 OMNISTIM

®

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.

CONFIDENTIAL AND PROPRIETARY

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.

CONFIDENTIAL AND PROPRIETARY

6 OMNISTIM

®

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.

CONFIDENTIAL AND PROPRIETARY

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.

®

CONFIDENTIAL AND PROPRIETARY

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.

A

B

C

S

T

D

Q

R

E

P

F

O

N

M

L

K

J

I

G

H

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.

CONFIDENTIAL AND PROPRIETARY

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.

CONFIDENTIAL AND PROPRIETARY

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

CONFIDENTIAL AND PROPRIETARY

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

CONFIDENTIAL AND PROPRIETARY

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

CONFIDENTIAL AND PROPRIETARY

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

o

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.

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 strong tingling sensation just under muscle contraction.

• 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.

®

CONFIDENTIAL AND PROPRIETARY

PROTOCOL / CLINICAL

INDICATION

NMES EDEMA-MUSCLE PUMP

Increase circulation, venous and lymphatic return through muscle pump.

NMES - MUSCLE SPASM

Relaxation of muscle spasm.

HI PERFORMANCE MFAC RE-ED STRENGTH

Treatment of muscle disuse atrophy for strength development.

HI PERFORMANCE MFAC RE-ED POWER

Treatment of muscle disuse atrophy for power development.

NMES - SEQ RE-ED

Activates muscles sequentially to simulate functional movement or firing patterns.

SPASTICITY REDUCTION RECIPROCAL INHIBITION

Reduces muscle tone (Spasm) of spastic muscle.

Medium Frequency Alternating Current (MFAC)

STIMULATION PARAMETERS MECHANISM OF ACTION APPLICATION TECHNIQUE OPERATIONAL SEQUENCE

• Press MFAC until screen reads "NMES EDEMA-MUSCLE PUMP"

• Press START / STOP until screen reads " SET OUTPUT A"

• 5000Hz - 35 BPS

• 4 Sec “ON” time and 12 Sec “OFF” time

• Reciprocal (alternating) timing pattern

• Ramps 2 Sec “ON/OFF”

• Treatment time of 15 minutes

• 5000 Hz - 80 BPS

• 10Sec “ON” time and 10Sec “OFF” time

• Channels fire simultaneously

• Ramps are set for 3 Sec “ON/OFF”

• Treatment time of 15 minutes

• 2500Hz – 75 BPS

• 10Sec “ON” time and 50Sec “OFF” time

• Channels fire simultaneously

• Ramps are set for 2 Sec “ON/OFF”

• Treatment time of 10 minutes.

• 2500Hz - 70 BPS

• 10Sec “ON” time and 50Sec “OFF” time

• Channels fire simultaneously

• Ramps are set for .2 Sec “ON” and 1

Sec “OFF”

• Treatment time of 10 minutes

• 2500Hz - 70 BPS

• 10Sec “ON” time and 50Sec “OFF” time

• Channels fire sequentially with a .2 Sec

delay

• Ramps are set for 2 Sec “ON/OFF”

• Treatment time of 15 minutes

• 5000 Hz - 80 BPS

• 2500Hz - 50 BPS

• 12Sec “ON” time and 18Sec “OFF” time

• Channels fire simultaneously

• Ramps are set for 6 Sec “ON” and 2

Sec “OFF”

• Treatment time of 20 minutes

Activation of muscle causing contraction of the agonist and antagonist to move the joint. The muscle pump action compresses fluids into the venous and lymphatic return, while improving blood flow to the edematous tissue.

Activation of muscle with electrical stimulation with a 1:1 ratio of on/off times causes muscle fatigue reducing muscle spasm. Sensory stimulation of the muscles also reduces pain and thus reflex muscle spasm.

Activation of muscle with electrical stimulation at a high intensity for a short time with long on/off ramps reduces atrophy and improves strength The patient should participate to the extent possible by contracting during the stimulation on time.

Activation of muscle with electrical stimulation at a high intensity for a short time with short “ON/OFF” ramps reduces atrophy and improves power. The patient should participate to the extent possible by contracting during the stimulation on time.

Activation of muscle causing contraction of the muscles in a sequential manner. May be used to retrain functional activity and reduce disuse atrophy in activities such as gait training for activation of swing phase to heel strike.

Stimulation of the spastic muscle's antagonists activates reciprocal inhibition of the spastic muscle reducing tone. Slow ramps decrease the potential to trigger spasticity of the agonist. Duration of relief is typically from 2-3 hours.

Target tissue - superficial and deep muscle groups and large joints. Bipolar set-up over agonist and antagonist muscles for target joint. Set intensity to elicit muscle contraction causing pain free joint movement typically a grade 3-4 muscle contraction. Reduce treatment time based on muscle fatigue.

Target tissue - superficial and deep muscle groups. Bipolar set-up over agonist and antagonist muscles for target muscle. Set intensity to elicit a grade 2-3 muscle contraction.

Target tissue - larger superficial and deep muscle groups Bipolar set-up over agonist and antagonist muscles for target muscle. Set intensity to elicit a grade 3-5 muscle contraction. Reduce treatment time based on muscle fatigue. Restrict joint movement by holding manually, or using weights or exercise bands.

Target tissue - larger superficial and deep muscle groups. Bipolar set-up over the muscles to be sequentially stimulated. Ch A fires first followed by Ch B. The delay and ramps may be adjusted using th e set parameter functions to simulate the desired fu nctional pattern. Set intensity to elicit a grade 3-5 muscle contraction. Reduce treatment time based on muscle fatigue. Restrict joint movement by holding manuall y, or using weights or exercise bands.

A single channel (A or B) is used over the spastic muscle's antagonist. Set intensity to elicit a grade2-3 muscle contraction. Ensure the intensity is not too high to induce overflow activation of the spastic muscle. Reduce treatment time based on muscle fatigue and inhibition of spasticity.

• Set Output A until the desired contraction of the Ch A muscle group is obtained.

• Press START / STOP until screen reads " SET OUTPUT B"

• Set Output B until the desired contraction of the Ch B muscle group is

obtained.

• 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 MFAC until screen reads "NMES - MUSCLE SPASM"

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

• Set Outputs A and B until the desired contraction level is obtained

• 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 MFAC until screen reads "HI PERFORMANCE MFAC RE-ED STRENGTH"

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

• Set Outputs A and B until the desired contraction level is obtained

• 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.

• Press MFAC until screen reads "HI PERFORMANCE MFAC RE-ED POWER"

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

• Set Outputs A and B until the desired contraction level is obtained

• 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.

• Press MFAC until screen reads "NMES - SEQ RE-ED"

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

• Set Outputs A and B until the desired contraction level is obtained

• 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 MFAC until screen reads "SPASTICITY REDUCTION RECIPROCAL INHIBITION "

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

• Set Outputs A and B until the desired contraction level is obtained

• Press START / STOP and T20 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.

20 OMNISTIM

500A USER MANUAL

®

CONFIDENTIAL AND PROPRIETARY

PROTOCOL / CLINICAL

INDICATION

ANALGESIA SENSORY

Symptomatic relief of pain from localized dermatome or segmental origin. Increase circulation.

ANALGESIA MOTOR

Symptomatic relief of pain with inflammation, or pain of a generalized or multisegmental nature.

NMES - R.O.M.

To provide estim assisted passive or active assisted R.O.M. at a joint.

NMES RE-ED

Treatment of muscle disuse atrophy for strength development.

NMES RE-ED ENDURANCE

Treatment of muscle disuse atrophy for endurance development.

DENERVATED MUSCLE D.C.

Low Volt Pulsed Current (LVPC)

STIMULATION PARAMETERS MECHANISM OF ACTION APPLICATION TECHNIQUE OPERATIONAL SEQUENCE

• Press LVPC 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 T20 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 LVPC 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 T20 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 LVPC until screen reads "NMES - R.O.M."

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

• Set Outputs A and/or B until the desired contraction level is obtained.

• 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 LVPC until screen reads "NMES RE-ED".

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

• Set Outputs A and/or B until the desired contraction level is obtained.

• 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 LVPC until screen reads "NMES RE-ED ENDURANCE".

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

• Set Outputs A and/or B until the desired contraction level is obtained.

• 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.

• Do not use this protocol.

• Protocol requires the use of a DC adapter which is no longer available

from ACP.

• 100Hz - 80uSec PD Continuous

• Treatment time of 20 minutes

• 4Hz - 250uSec PD Continuous

• Treatment time of 20 minutes

• 35Hz - 200uSec PD

• 4 Sec “ON” time and 12 Sec “OFF” time

• Simultaneous timing pattern

• Ramps are set for 2 Sec “ON/OFF”

• Treatment time of 30 minutes

• 50Hz - 200uSec PD

• 10 Sec “ON” time and 50 Sec “OFF” time

• Channels fire simultaneously

• Ramps are set for 2 Sec “ON/OFF”

• Treatment time of 15 minutes

• 10Hz - 200uSec PD

• 5 Sec “ON” time and 30 Sec “OFF” time

• Channels fire simultaneously

• Ramps are set for 1 Sec “ON/OFF”

• Treatment time of 30 minutes

No longer used

Sensory stimulation reduces pain through segmental release of Enkephalin and Dynorphin (Gate Control). It also activates local vasodilation increasing local circulation. Application of negative polarity over the edematous site has been demonstrated to reduce post-traumatic edema in clinical trials.

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.

Activation of muscle causing contraction of the agonist and antagonist to move the joint and improve the R.O.M. Reduce treatment time based on muscle fatigue.

Activation of muscle with electrical stimulation at a high intensity for a short time reduces disuse atrophy and improves strength and power. The patient should participate to the extent possible by contracting during the stimulation “ON” time. Reduce treatment time based on muscle fatigue.

Activation of muscle with electrical stimulation at lower intensity for a longer time reduces disuse atrophy and improves endurance. The patient should participate to the extent possible by contracting during the stimulation "ON" time. Reduce treatment time based on muscle fatigue.

Intentionally left blank

Target tissue-superficial. Bilateral bipolar 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. Bipolar placement over local and distal acu / trigger point or at spinal segmental level. Set intensity to elicit a motor twitch.

Target tissue - smaller superficial muscle groups. Bipolar set-up over agonist muscle for targeted joint. Set intensity to elicit muscle contraction causing pain free joint movement typically a grade 3-4 muscle contraction.

Target tissue - smaller superficial muscle groups. Bipolar set-up over agonist and antagonist muscl es. Set intensity to elicit a grade 3-5 muscle contraction. Reduce treatment time based on muscle fatigue. Restrict joint movement by holding manually, or usi ng weights or exercise bands.

Target tissue - smaller superficial muscle groups. Bipolar set-up over agonist and antagonist muscles for target muscle. Set intensity to elicit a grade 2-4 muscle contraction. Reduce treatment time based on muscle fatigue. Restrict joint movement by holding manuall y, or using weights or exercise bands.

Intentionally left blank

OMNISTIM

500A USER MANUAL 21

• Do not use this protocol.

LOW INTENSITY D.C.

No longer used

Intentionally left blank

• Protocol requires the use of a DC adapter which is no longer available

from ACP.

®

CONFIDENTIAL AND PROPRIETARY

PROTOCOL / CLINICA L

INDICATION

HVPC SENSORY

Symptomatic relief of pain from localized dermatome or segmental origin Increase circulation. Increase circulation.

EDEMA-MUSCLE PUMP

Increase circulation, venous and lymphatic return through muscle pump.

High Volt Pulsed Current (HVPC)

STIMULATION PARAMETERS MECHANISM OF ACTION APPLICATION TECHNIQUE OPERATIONAL SEQUENCE

• Press HVPC until screen reads "HVPC SENSORY"

• Press START / STOP until screen reads " SET OUTPUT A

INTENSITY"

• Set Output A/HVPC unt il the patient feels the desired sensation.

• Press START / STOP and T20 will display in upper right corner.

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

• The tr eatment will end at the end of the preset time or if the patient

safety switch is pressed.

• Press HVPC until screen reads "EDEMA - MUSCLE PUMP"

• Press START / STOP until screen reads " SET OUTPUT A

INTENSITY"

• Set Output A/HVPC until the desired contraction level is obtained

• Press START / STOP and T20 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.

• 125Hz + or – Polarity Continuous

• Treatment time of 20-45 minutes

• 50Hz + or – Polarity

• 4 Sec “ON” time 12 Sec “OFF” time

• Single channel only (A)

• Ramps 2 Sec “ON/OFF”

• Treatment time of 20 minutes

Sensory stimulation reduces pain through segmental release of Enkephalin and Dynorphin (Gate Control). It also activates local vasodilation increasing local circulation. Application of negative polarity over the edematous site has been demonstrated to reduce post-traumatic edema in clinical trials.

Activation of muscle causing contraction of the agonist to move the joint. The muscle pump action compresses fluids into the venous and lymphatic return, while improving blood flow to the edematous tissue. Reduce treatment time based on muscle fatigue.

Target tissue - superficial and deep. Bipolar, appropriate polarity through the target tissue return electrode at spinal segmental electrode or local nerve. Set intensity to elicit a pleasant tingling sensation, just below the muscle contraction.

Target tissue - superficial and deep muscle groups and joints. Bipolar set-up over agonist muscle for target joint or edematous tissue. Set intensity to elicit muscle contraction causing pain free joint movement typically a grade 3-4 muscle contraction.

22 OMNISTIM

500A USER MANUAL

OMNISTIM® 500A USER MANUAL 23

STIMULATION THERAPY MODES

Interferential Current Therapy (IFC)

The new Webster Encyclopedia Dictionary of the English Language defines interference as “the mutual action of waves of any kind (water, sound, heat or light) upon each other, by which the vibrations and their effects are increased, diminished or neutralized.”

As such, interferential current (IFC) therapy requires at least two signal sources, which “interfere” within the tissue to be treated. The resulting interference of the generators generates therapeutically useful stimulation of the area undergoing treatment. Interferential current therapy technique relies on amplitude differences between two or more isolated independent signals to produce fields of higher or lower intensity within the tissue.

The purpose of interferential current therapy is to provide deep tissue treatment, which is not generally obtainable with conventional electrotherapy approaches. Its primary application is in the reduction of pain and in the stimulation of increased blood flow in the deeper tissues and muscles.

1. Frequency Difference (FD) Technique

Dr. Hans Nemec, an Austrian physician, first introduced the concept of frequency difference interferential current therapy to the medical community in the late forties. The original U.S. patent (2,622,601) for the technique was filed on October 27, 1948 and granted on December 23, 1952. It has since expired and many manufacturers worldwide produce interferential current therapy devices according to Dr. Nemec’s original method.

Simply stated, electric currents with frequencies in the range of 1000-10,000 Hz, known as medium frequency currents, are run through the tissue to be treated. These frequencies inhibit nerve conduction based on the fact that they cause temporary nerve membrane depolarization while present. This effect is known as Wedensky Inhibition. 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 occurs as a result of the decreased tissue resistance at higher frequencies.

If the frequencies of the two generators are not the same, then a beat frequency (which is the difference between the two signal frequencies) is produced at right angles to the plane of the four stimulation electrodes. This beat frequency modulates the medium frequency current to produce a burst medium frequency within the tissues.

The effects of frequency difference interferential current therapy may be described as follows:

a. Stimulation of deep tissue only with two fields. b. Produces surface Nerve Block via Wedensky Inhibition (helpful in acute pain treatment).

2. 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 interferential stimulators. This alteration of relative amplitude changes the phase relationships and the position of the summated field in the tissue.

Advantages of Dynamic Vector:

1. When the patient expresses a poor pain location

and cannot indicate whether or not the therapy feels the strongest at the subjectively perceived location of the problem.

2. When the target tissue area is extremely large.

3. When you wish to increase the amount of current

density in the tissues to obtain a higher therapeutic dosage.

4. When your electrode placement sites are less than

optimal.

CONFIDENTIAL AND PROPRIETARY

24 OMNISTIM® 500A USER MANUAL

3. IFC FF-Full Field Mode:

The well-known attributes of modulated medium frequency currents, i.e. deep tissue penetration, asynchronous neural stimulation, and low tissue resistance, allows the creation of an interferential therapy system capable of both deep and superficial stimulation with the goals of maximizing sensory inputs. This technique is referred to as full field interferential current therapy. Full field amplitude summation interferential current therapy relies on the addition and subtraction of two intersecting currents within the tissue. This effect is based on the relative phase differences between the currents at different positions in the field. The

following technique is used in the OMNISTIM

®

500 when in the full field mode of operation.

The highest intensity field is obtained in the deep tissue at bisecting angles to the out-of-phase electrodes. This technique offers three stimulation fields.

Amplitude Summation - IFC Technique

Three zones of

stimulation

AMPLITUDE SUMMATION IFC TECHNIQUE

RATE SCAN ON OR OFF

2500 or 5000 Hz Pulsed at 100Hz

sensory

2500 or 5000 Hz Pulsed at 100Hz

Should the clinician desire rapid analgesia and maximum comfort in both the surface and deep tissues, continuous

non-modulated MF currents may be used with the OMNISTIM

®

, which will produce strong nerve blocks (Wedensky Inhibition) throughout the entire treatment field. This is often useful in the mobilization of joints, prior to transverse friction massage, or for relieving acute pain. It should be noted that this technique would produce only transient relief of pain.

The effects of full field interferential current therapy may be described as follows:

RATE SCAN ON OR OFF

2500 or 5000 Hz Pulsed at 100Hz

a. Stimulation of deep and surface

tissues.

2500 or 5000 Hz

b. May be used to produce deep and

surface analgesia via nerve block (Wedensky Inhibition) when MF mode is used.

4. Interferential Current Therapy IFC Treatment Programs

The IFC mode contains five pre-programmed modes and a custom program, which may be programmed and saved by the user. The custom program will remain as long as the batteries remain charged or are not removed.

Three

zones of

Wedensky

Inhibition

All parameters other than the Carrier frequency may be varied during operation. The following programs are available in IFC mode:

FULL FIELD WEDENSKY INHIBITION

2500 or 5000 Hz

CONFIDENTIAL AND PROPRIETARY

OMNISTIM® 500A USER MANUAL 25

ANALGESIA – SENSORY (FULL FIELD):

Target tissue is superficial and deep. 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 minutes to 2 hours. Fast onset of relief usually within 20 minutes.

PARAMETER DEFAULT VALUES

IFC Mode: Full Field Carrier frequency: 5.0 KHz Burst frequency: 100Hz .0 Hz to 999 Hz

Burst rate scan: 20% 0 – 50% Burst scan time: 10 seconds 0 – 20 Seconds Beat: Sweep: Rate Scan Time: Rate scan: ON ON or OFF

Vector: Fast 90º Auto Intensity: 10% 0 – 20%

Treatment time: 15 minutes 0 – 99 Minutes Waveform: Alternating Current Output: 0 mA 0 – 99 mA

RANGE OF USER

ADJUSTABLE VALUES

2.0 KHz, 2.5 KHz,

4.0 KHz 5.0 KHz

OFF, Fast 90º, Slow 90º,

Fast 45º, Slow 45º

ANALGESIA – SENSORY (FREQUENCY DIFFERENCE):

Target is deep tissue. 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 minutes to 2 hours. Fast onset of relief usually within 20 minutes.

PARAMETER DEFAULT VALUES

IFC Mode: Frequency Difference Carrier frequency: 5.0 KHz Burst frequency:

Burst rate scan: Burst scan time: Beat: 80 Hz .0 – 250 Hz Sweep: 120 Hz .0 – 250 Hz Rate Scan Time: 15 Seconds 0 – 20 Seconds Rate scan:

Vector: Fast 90º Auto Intensity: 0% 0 – 20%

Treatment time: 15 minutes 0 – 99 Minutes Waveform: Alternating Current Output: 0 mA 0 – 99 mA

RANGE OF USER

ADJUSTABLE VALUES

2.0 KHz, 2.5 KHz,

4.0 KHz 5.0 KHz

OFF, Fast 90º, Slow 90º,

Fast 45º, Slow 45º

CONFIDENTIAL AND PROPRIETARY

26 OMNISTIM® 500A USER MANUAL

ANALGESIA – MOTOR (FULL FIELD):

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

PARAMETER DEFAULT VALUES

IFC Mode: Full Field Carrier frequency: 2.5 KHz Burst frequency: 4.0 Hz .0 Hz to 999 Hz

Burst rate scan: 50% 0 – 50% Burst scan time: 10 seconds 0 – 20 Seconds Beat: Sweep: Rate Scan Time: Rate scan: ON On or OFF

Vector: Fast 90º Auto Intensity: 0% 0 – 20%

Treatment time: 15 minutes 0 – 99 Minutes Waveform: Alternating Current Output: 0 mA 0 – 99 mA

ANALGESIA – MOTOR (FREQUENCY DIFFERENCE):

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

PARAMETER DEFAULT VALUES

IFC Mode: Frequency Difference Carrier frequency: 2.5 KHz Burst frequency:

Burst rate scan: Burst scan time: Beat: 2 Hz .0 – 250 Hz Sweep: 5 Hz .0 – 250 Hz Rate Scan Time: 15 Seconds 0 – 20 Seconds Rate scan:

Vector: Fast 90º Auto Intensity: 0% 0 – 20%

Treatment time: 20 minutes 0 – 99 Minutes Waveform: Alternating Current Output: 0 mA 0 – 99 mA

RANGE OF USER

ADJUSTABLE VALUES

2.0 KHz, 2.5 KHz,

4.0 KHz 5.0 KHz

OFF, Fast 90º, Slow 90º,

Fast 45º, Slow 45º

RANGE OF USER

ADJUSTABLE VALUES

2.0 KHz, 2.5 KHz,

4.0 KHz 5.0 KHz

OFF, Fast 90º, Slow 90º,

Fast 45º, Slow 45º

CONFIDENTIAL AND PROPRIETARY

OMNISTIM® 500A USER MANUAL 27

ANALGESIA / MOTOR – SENSORY:

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

PARAMETER DEFAULT VALUES

IFC Mode: Full Field Carrier frequency: 5.0 KHz Burst frequency: 15 – 2 – 100 Hz Burst rate scan: Burst scan time: Beat: Sweep: Rate Scan Time: Rate scan:

Vector: Fast 90º Auto Intensity: 10% 0 – 20%

Treatment time: 30 minutes 0 – 99 Minutes Waveform: Alternating Current Output: 0 mA 0 – 99 mA

RANGE OF USER

ADJUSTABLE VALUES

OFF, Fast 90º, Slow 90º,

Fast 45º, Slow 45º

ANALGESIA SENSORY – MOTOR:

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

PARAMETER DEFAULT VALUES

IFC Mode: Full Field Carrier frequency: 5.0 KHz Burst frequency: 100 – 2 Hz Burst rate scan: Burst scan time: Beat: Sweep: Rate Scan Time: Rate scan:

Vector: Fast 90º Auto Intensity: 10% 0 – 20%

Treatment time: 30 minutes 0 – 99 Minutes Waveform: Alternating Current Output: 0 mA 0 – 99 mA

RANGE OF USER

ADJUSTABLE VALUES

OFF, Fast 90º, Slow 90º,

Fast 45º, Slow 45º

CONFIDENTIAL AND PROPRIETARY

28 OMNISTIM® 500A USER MANUAL

ANALGESIA – NERVE BLOCK:

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.

PARAMETER DEFAULT VALUES

IFC Mode: Full Field Carrier frequency: 5.0 KHz 5.0 KHz or 10.0 KHz Burst frequency: Burst rate scan: Burst scan time: Beat: Sweep: Rate Scan Time: Rate scan:

Vector: OFF Auto Intensity: 10% 0 – 20%

Treatment time: 10 minutes 0 – 99 Minutes Waveform: Alternating Current Output: 0 mA 0 – 70 mA

IFC CUSTOM (FULL FIELD):

Protocol fully adjustable by therapist, which can be customized for surface to deep tissue treatment.

PARAMETER DEFAULT VALUES

IFC Mode: Full Field Carrier frequency: 5.0 KHz Burst frequency: 80 Hz .0 Hz to 999 Hz

Burst rate scan: 20% 0 – 50% Burst scan time: 10 seconds 0 – 20 Seconds Beat: Sweep: Rate Scan Time: Rate scan: ON On or OFF

Vector: OFF Auto Intensity: 20% 0 – 20%

Treatment time: 15 minutes 0 – 99 Minutes Waveform: Alternating Current Output: 0 mA 0 – 99 mA

RANGE OF USER

ADJUSTABLE VALUES

OFF, Fast 90º, Slow 90º,

Fast 45º, Slow 45º

RANGE OF USER

ADJUSTABLE VALUES

2.0 KHz, 2.5 KHz,

4.0 KHz 5.0 KHz

OFF, Fast 90º, Slow 90º,

Fast 45º, Slow 45º

CONFIDENTIAL AND PROPRIETARY

OMNISTIM® 500A USER MANUAL 29

IFC CUSTOM (FREQUENCY DIFFERENCE):

Protocol fully adjustable by therapist, which can be customized for deep tissue treatment.

PARAMETER DEFAULT VALUES

IFC Mode: Frequency Difference Carrier frequency: 5.0 KHz Burst frequency:

Burst rate scan: Burst scan time: Beat: 50 Hz .0 – 250 Hz Sweep: 100 Hz .0 – 250 Hz Rate Scan Time: 15 Seconds 0 – 20 Seconds Rate scan:

Vector: OFF Auto Intensity: 20% 0 – 20%

Treatment time: 20 minutes 0 – 99 Minutes Waveform: Alternating Current Output: 0 mA 0 – 99 mA

RANGE OF USER

ADJUSTABLE VALUES

2.0 KHz, 2.5 KHz,

4.0 KHz 5.0 KHz

OFF, Fast 90º, Slow 90º,

Fast 45º, Slow 45º

5. Adjustable Parameters

Pushing the set button during operation brings up the available adjustable parameters. These may be altered during system operation with the exception of the carrier frequency and mode of operation (Full Field or Frequency Difference), which may only be altered when the output is turned off to the patient. (This prevents accidental shock to the patient resulting from the change in pulse charge.) To adjust any parameter simply push the parameter set button at any time during operation. This will display a parameter, which may be changed. Repeated pushing of the parameter set button will continue to display parameters one at a time until all parameters have been displayed. To change the parameter use the timer/parameter set rocker switch on the front panel to increase, decrease or change the value of the parameter.

BEAT - SWEEP: Beat adjustable from .1 - 250 Hz Sweep adjustable from beat to 250 Hz RATE SWEEP TIME: Adjustable from 1-20 seconds CARRIER FREQUENCY: Select 2000, 2500, 4000 or 5000 Hz. VECTOR TECHNIQUE: The vector scans the amplitude of each channel simultaneously. The modulation

may be set to sweep a 45 or 90-degree field. The sweep time of the vector can be set at fast (10 second up and down sweep time) or Slow (60 second up and down sweep time).

AUTO INTENSITY: Adjusts the output during treatment automatically from 0 to 20% user programmable.

IFC FD-Frequency Difference Interferential Mode:

This mode is generally used for treatment of deep tissue with nerve block effects occurring at the surface tissue. Output channel A fixed at 2000, 2500, 4000 or 5000 Hz. Output channel B variable from 0.1 to 250 Hz Beat rate and sweep may be set during treatment.

CONFIDENTIAL AND PROPRIETARY

30 OMNISTIM® 500A USER MANUAL

Medium Frequency Alternating Current (MFAC)

1. Muscle Stimulation

Since the mid 18th Century, neuromuscular electrical stimulation (NMES) has been used as an adjunctive therapy for various neuromuscular and musculoskeletal disorders. Clinicians and investigators have been successfully using NMES to facilitate muscle contraction, to re-educate muscle action, to aid in the prevention of atrophy and to overcome neuromuscular inhibition following injury or surgery.

a. Isometric Muscle Stimul ation

NMES during isometric exercise offers a reduced threat of over-stress

and re-injury to the joint. NMES is clinically used at the mid point of the range of motion where the muscle can generate maximum torque.

Procedure:

Mode NMES Time ON 10 Sec

Time OFF 50 Sec ON Ramp 2 Sec OFF Ramp 2 Sec Pulse Rate 35-50Hz

Gradually increase intensity to maximum patient tolerance during each contraction. The intensity should be increased to produce at least 50 to 80% of Maximum Voluntary Contraction (MVC). Place ACP Reusable Electrodes in a bipolar or quadripolar pattern on the muscle(s) being stimulated. The treatment should be approximately 15 minutes duration 3 to 4 times a week.

b. Muscle Spasm Reduction

NMES can be utilized to induce fatigue of muscles in spasm. Researchers have found that the greatest fatigue of muscles occurs when the muscle contraction relaxation times are equivalent (1:1 ratio) and when higher frequencies (60-80 Hz) are used. Electrical stimulation of the motor neuron using medium frequency currents

Mode NMES Time ON 10 Sec

Time OFF 10 Sec ON Ramp 1-2 Sec OFF Ramp 1-2 Sec Pulse Rate 35-50Hz

results in neuromuscular junction fatigue.

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.

c. Increased Blood Flow / Edema Reduction Long and short-term electrical stimulation of muscle has been shown to

alter the vascular dynamics affecting local muscle blood and lymph flow. It has been shown that blood-flow increased significantly during the first minute of electrical stimulation and remained elevated during and for ten minutes following stimulation. The immediacy of vasodilatation following electrical stimulation indicates that the vascular response is a functional, reflexive response. In addition, long-term electrical stimulation has been shown to increase the number of capillaries and thus improve the capillary blood-flow to the stimulated muscle. Not all types and parameters of electrical stimulation affect the blood-flow dynamics of the muscle being stimulated. Therefore, the following clinical parameters should be adhered to for optimal effectiveness.

Procedure:

Place one or two sets of electrodes in a bipolar or quadripolar technique over the selected muscle(s). Gradually increase intensity to 15 to 30% of maximum voluntary contractions. Continue the treatment for approximately 10 minutes.

Mode Time ON 15 Sec

Time OFF 50 Sec ON Ramp 2 Sec OFF Ramp 2 Sec Pulse Rate 50Hz

Mode Time ON 4 Sec

Time OFF 4 Sec ON Ramp 2 Sec OFF Ramp 2 Sec Pulse Rate 35Hz

Blood Flow

NMES

Simultaneous

Muscle Pump

Edema Reduction

NMES

Alternate

ON - OFF TIME: On time adjustable from 0 – 30 seconds, Off time adjustable from 0 - 199 seconds CHANNEL TIMING: Simultaneous, alternate or delayed channels DELAY MODE: Adjustable from 0-9.9 seconds AUTO INTENSITY: Adjusts the output during treatment automatically from 0 to 20% user programmable.

CONFIDENTIAL AND PROPRIETARY

OMNISTIM® 500A USER MANUAL 31

MAFC WAVEFORM

Treatment Programs

2.

The MFAC mode contains six pre-programmed modes and a custom program which may be programmed and saved by the user. The custom program will remain as long as the batteries remain charged or are not removed. All parameters other than the Carrier frequency may be varied during operation. The following programs are available in MFAC mode:

NMES EDEMA - MUSCLE PUMP:

Activation of muscle causing contraction of the agonist and antagonist to move the joint. The muscle pump action compresses fluids into the venous and lymphatic return, while improving blood flow to the edematous tissue.

PARAMETER DEFAULT VALUES

Carrier frequency: 5.0 KHz Burst frequency: 35Hz .0 Hz to 999 Hz

Burst rate scan: 20% 0 – 50% Burst scan time: 4 seconds 0 – 20 Seconds Rate scan: ON ON or OFF Auto Intensity: 0% 0 – 20% Treatment time: 15 minutes 0 – 99 Minutes Channel B delay: Ramp up: 2 seconds .0 – 9.9 seconds Ramp down: 2 seconds .0 – 9.9 seconds Time on: 4 seconds 1 – 30 seconds Time off: 12 seconds 0 – 199 seconds

Channels A/B: ALTERNATE Waveform: Alternating Current

Output: 0 mA 0 – 99 mA

RANGE OF USER

ADJUSTABLE VALUES

2.0 KHz, 2.5 KHz,

4.0 KHz 5.0 KHz

ALTERNATE or

SIMULTANEOUS

CONFIDENTIAL AND PROPRIETARY

32 OMNISTIM® 500A USER MANUAL

NMES - MUSCLE SPASM:

Activation of muscle with electrical stimulation with a 1:1 ratio of ON/OFF times causes muscle fatigue reducing muscle spasm. Sensory stimulation of the muscles also reduces pain and thus reflex muscle spasm.

PARAMETER DEFAULT VALUES

Carrier frequency: 5.0 KHz Burst frequency: 80Hz .0 Hz to 999 Hz

Burst rate scan: 20% 0 – 50% Burst scan time: 8 seconds 0 – 20 Seconds Rate scan: ON ON or OFF Auto Intensity: 0% 0 – 20% Treatment time: 15 minutes 0 – 99 Minutes Channel B delay: Ramp up: 3 seconds .0 – 9.9 seconds Ramp down: 3 seconds .0 – 9.9 seconds Time on: 10 seconds 1 – 30 seconds Time off: 10 seconds 0 – 199 seconds

Channels A/B: SIMULTANEOUS Waveform: Alternating Current

Output: 0 mA 0 – 99 mA

RANGE OF USER

ADJUSTABLE VALUES

2.0 KHz, 2.5 KHz,

4.0 KHz 5.0 KHz

ALTERNATE or

SIMULTANEOUS

HIGH PERFORMANCE MFAC RE-ED STRENGTH:

Activation of muscle with electrical stimulation at a high intensity for a short time with long ON/OFF ramps reduces atrophy and improves strength. The patient should participate to the extent possible by contracting during the stimulation ON time.

PARAMETER DEFAULT VALUES

Carrier frequency: 2.5 KHz Burst frequency: 75 Hz .0 Hz to 999 Hz

Burst rate scan: 20% 0 – 50% Burst scan time: 4 seconds 0 – 20 Seconds Rate scan: ON ON or OFF Auto Intensity: 0% 0 – 20% Treatment time: 10 minutes 0 – 99 Minutes Channel B delay: .0 seconds 0 – 99 Minutes Ramp up: 2 seconds .0 – 9.9 seconds Ramp down: 2 seconds .0 – 9.9 seconds Time on: 10 seconds 1 – 30 seconds Time off: 50 seconds 0 – 199 seconds

Channels A/B: SIMULTANEOUS Waveform: Alternating Current

Output: 0 mA 0 – 99 mA

RANGE OF USER

ADJUSTABLE VALUES

2.0 KHz, 2.5 KHz,

4.0 KHz 5.0 KHz

B DELAYED, ALTERNATE

or SIMULTANEOUS

CONFIDENTIAL AND PROPRIETARY

OMNISTIM® 500A USER MANUAL 33

HIGH PERFORMANCE MFAC RE-ED POWER:

Activation of muscle with electrical stimulation at a high intensity for a short time with short ON/OFF ramps reduces atrophy and improves power. The patient should participate to the extent possible by contracting during the stimulation ON time.

PARAMETER DEFAULT VALUES

Carrier frequency: 2.5 KHz Burst frequency: 70 Hz .0 Hz to 999 Hz

Burst rate scan: 20% 0 – 50% Burst scan time: 4 seconds 0 – 20 Seconds Rate scan: ON ON or OFF Auto Intensity: 0% 0 – 20% Treatment time: 10 minutes 0 – 99 Minutes Channel B delay: .0 seconds .0 – 9.9 seconds Ramp up: 0.2 seconds .0 – 9.9 seconds Ramp down: 1 seconds .0 – 9.9 seconds Time on: 10 seconds 1 – 30 seconds Time off: 50 seconds 0 – 199 seconds

Channels A/B: SIMULTANEOUS Waveform: Alternating Current

Output: 0 mA 0 – 99 mA

RANGE OF USER

ADJUSTABLE VALUES

2.0 KHz, 2.5 KHz,

4.0 KHz 5.0 KHz

B DELAYED, ALTERNATE

or SIMULTANEOUS

NMES SEQUENTIAL RE-ED:

Activation of muscle causing contraction of the muscles in a sequential manner. May be used to retrain functional activity and reduce disuse atrophy in activities such as gait training for activation of swing phase to heel strike.

PARAMETER DEFAULT VALUES

Carrier frequency: 2.5 KHz Burst frequency: 70 Hz .0 Hz to 999 Hz

Burst rate scan: 20% 0 – 50% Burst scan time: 4 seconds 0 – 20 Seconds Rate scan: ON ON or OFF Auto Intensity: 0% 0 – 20% Treatment time: 15 minutes 0 – 99 Minutes Channel B delay: 0.2 seconds .0 – 9.9 seconds Ramp up: 2 seconds .0 – 9.9 seconds Ramp down: 2 seconds .0 – 9.9 seconds Time on: 10 seconds 1 – 30 seconds Time off: 50 seconds 0 – 199 seconds

Channels A/B: B DELAYED Waveform: Alternating Current

Output: 0 mA 0 – 99 mA

RANGE OF USER

ADJUSTABLE VALUES

2.0 KHz, 2.5 KHz,

4.0 KHz 5.0 KHz

B DELAYED, ALTERNATE

or SIMULTANEOUS

CONFIDENTIAL AND PROPRIETARY

34 OMNISTIM® 500A USER MANUAL

SPASTICITY REDUCTION:

Stimulation of the spastic muscle’s antagonists activates reciprocal inhibition of the spastic muscle reducing tone. Slow ramps decrease the potential to trigger spasticity of the agonist.

PARAMETER DEFAULT VALUES

Carrier frequency: 2.5 KHz Burst frequency: 50 Hz .0 Hz to 999 Hz

Burst rate scan: 20% 0 – 50% Burst scan time: 4 seconds 0 – 20 Seconds Rate scan: ON ON or OFF Auto Intensity: 0% 0 – 20% Treatment time: 20 minutes 0 – 99 Minutes Channel B delay: .0 seconds .0 – 9.9 seconds Ramp up: 6 seconds .0 – 9.9 seconds Ramp down: 2 seconds .0 – 9.9 seconds Time on: 12 seconds 1 – 30 seconds Time off: 18 seconds 0 – 199 seconds

Channels A/B: SIMULTANEOUS Waveform: Alternating Current

Output: 0 mA 0 – 99 mA

MFAC CUSTOM:

MFAC protocol which can be customized by the therapist.

PARAMETER DEFAULT VALUES

Carrier frequency: 2.5 KHz Burst frequency: 50 Hz .0 Hz to 999 Hz

Burst rate scan: 20% 0 – 50% Burst scan time: 4 seconds 0 – 20 Seconds Rate scan: ON ON or OFF Auto Intensity: 20% 0 – 20% Treatment time: 15 minutes 0 – 99 Minutes Channel B delay: .0 seconds .0 – 9.9 seconds Ramp up: 2 seconds .0 – 9.9 seconds Ramp down: 2 seconds .0 – 9.9 seconds Time on: 5 seconds 1 – 30 seconds Time off: 25 seconds 0 – 199 seconds

Channels A/B: SIMULTANEOUS Waveform: Alternating Current

Output: 0 mA 0 – 99 mA

3. Adjustable Parameters

Pushing the set button during operation brings up the available adjustable parameters. These may be altered during system operation with the exception of the carrier frequency, which may only be altered when the output is turned off to the patient. (This prevents accidental shock to the patient resulting from the change in pulse charge.) To adjust any parameter simply push the parameter set button at any time during operation. This will display a parameter, which may be changed. Repeated pushing of the parameter set button will continue to display parameters one at a time until all parameters have been displayed. To change the parameter use the timer/parameter set rocker switch on the front panel to increase, decrease or change the value of the parameter.

BURST RATE: Adjustable from 0 (cw) - 999 Hz RATE SWEEP TIME: Adjustable from 0-20 seconds BURST SWEEP %: Adjustable from 0 - 50% CARRIER FREQUENCY: Select 2000, 2500, 4000 or 5000 Hz ON-OFF RAMPS: Adjustable from 0 to 9.9 seconds

RANGE OF USER

ADJUSTABLE VALUES

2.0 KHz, 2.5 KHz,

4.0 KHz 5.0 KHz

B DELAYED, ALTERNATE

or SIMULTANEOUS

RANGE OF USER

ADJUSTABLE VALUES

2.0 KHz, 2.5 KHz,

4.0 KHz 5.0 KHz

B DELAYED, ALTERNATE

or SIMULTANEOUS

CONFIDENTIAL AND PROPRIETARY

OMNISTIM® 500A USER MANUAL 35

Low Volt Pulsed Current (LVPC)

1. Treatment Programs

The LVPC mode contains seven pre-programmed modes and a custom program, which may be programmed and saved by the user. The custom program will remain as long as the batteries remain charged or are not removed. All parameters may be varied during operation. The following programs are available in LVPC mode:

ANALGESIA SENSORY:

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 minutes to 2 hours. Fast onset of relief achieved usually within 20 minutes.

PARAMETER DEFAULT VALUES

Phase duration: 80 µS 30 µS – 500 µS Pulse rate: 100 Hz .0 Hz to 999 Hz Phase duration mod: Modulation time: Modulation: OFF ON or OFF Auto Intensity: 10% 0 – 20% Treatment time: 20 minutes 0 – 99 minutes Channel B delay: Ramp up: Ramp down: Time on: Time off: Channels A/B: Waveform: Asymetric Biphasic Output: 0 mA 0 – 99 mA

RANGE OF USER

ADJUSTABLE VALUES

ANALGESIA MOTOR:

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.

PARAMETER DEFAULT VALUES

Phase duration: 250 µS 30 µS – 500 µS Pulse rate: 4 Hz .0 Hz to 999 Hz Phase duration mod: Modulation time: Modulation: OFF ON or OFF Auto Intensity: 10% 0 – 20% Treatment time: 20 minutes 0 – 99 minutes Channel B delay: Ramp up: Ramp down: Time on: Time off: Channels A/B: Waveform: Asymetric Biphasic Output: 0 mA 0 – 99 mA

RANGE OF USER

ADJUSTABLE VALUES

CONFIDENTIAL AND PROPRIETARY

36 OMNISTIM® 500A USER MANUAL

NMES – R.O.M.:

Activation of muscle causing contraction of the agonist and antagonist to move the joint and improve the R.O.M. The patient should participate to the extent possible by contracting during the stimulation time.

PARAMETER DEFAULT VALUES

Phase duration: 200 µS 30 µS – 500 µS Pulse rate:: 35 Hz .0 Hz to 999 Hz Phase duration mod: Modulation time: Modulation: OFF ON or OFF Auto Intensity: 0% 0 – 20% Treatment time: 30 minutes 0 – 99 minutes Channel B delay: Ramp up: 2 seconds .0 – 9.9 seconds Ramp down: 2 seconds .0 – 9.9 seconds Time on: 4 seconds 1 – 30 seconds Time off: 12 seconds 0 – 199 seconds Channels A/B: SIMULTANEOUS ALTERNATE or SIMULTANEOUS Waveform: Asymetric Biphasic Output: 0 mA 0 – 99 mA

NMES RE-ED:

Activation of muscle with electrical stimulation at a high intensity for a short time reduces disuse atrophy and improves strength and power. The patient should participate to the extent possible by contracting during the stimulation time.

PARAMETER DEFAULT VALUES

Phase duration: 200 µS 30 µS – 500 µS Pulse rate: 50 Hz .0 Hz to 999 Hz Phase duration mod: Modulation time: Modulation: Auto Intensity: 0 % 0 – 20% Treatment time: 15 minutes 0 – 99 minutes Channel B delay: 0.0 seconds .0 – 9.9 seconds Ramp up: 2 seconds .0 – 9.9 seconds Ramp down: 2 seconds .0 – 9.9 seconds Time on: 10 seconds 1 – 30 seconds Time off: 50 seconds 0 – 199 seconds

Channels A/B: SIMULTANEOUS Waveform: Asymetric Biphasic

Output: 0 mA 0 – 99 mA

RANGE OF USER

ADJUSTABLE VALUES

RANGE OF USER

ADJUSTABLE VALUES

B DELAYED, ALTERNATE or

SIMULTANEOUS

CONFIDENTIAL AND PROPRIETARY

OMNISTIM® 500A USER MANUAL 37

NMES RE-ED ENDURANCE:

Activation of muscle with electrical stimulation at lower intensity for a longer time reduces disuse atrophy and improves endurance. The patient should participate to extent possible by contracting during stimulation ON time.

PARAMETER DEFAULT VALUES

Phase duration: 200 µS 30 µS – 500 µS Pulse rate: 10 Hz .0 Hz to 999 Hz Phase duration mod: Modulation time: Modulation: Auto Intensity: Treatment time: 30 minutes 0 – 99 Minutes Channel B delay: Ramp up: 1 seconds .0 – 9.9 seconds Ramp down: 1 seconds .0 – 9.9 seconds Time on: 5 seconds 1 – 30 seconds Time off: 30 seconds 0 – 199 seconds

Channels A/B: SIMULTANEOUS Waveform: Asymetric Biphasic

Output: 0 mA 0 – 99 mA

RANGE OF USER

ADJUSTABLE VALUES

B DELAYED, ALTERNATE or

SIMULTANEOUS

DENERVATED MUSCLE DC:

PARAMETER DEFAULT VALUES

Phase duration: Pulse rate:

Phase duration mod: Modulation time: Modulation: Auto Intensity: Treatment time: Channel B delay: Ramp up: Ramp down: Time on: Time off: Channels A/B: Waveform: Output:

DO NOT USE THIS PROTOCOL

NO LONGER SUPPORTED

RANGE OF USER

ADJUSTABLE VALUES

LOW INTENSITY DC:

PARAMETER DEFAULT VALUES

Phase duration: Pulse rate:

Phase duration mod: Modulation time: Modulation: Auto Intensity: Treatment time: Channel B delay: Ramp up: Ramp down: Time on: Time off: Channels A/B: Waveform: Output:

DO NOT USE THIS PROTOCOL

NO LONGER SUPPORTED

RANGE OF USER

ADJUSTABLE VALUES

CONFIDENTIAL AND PROPRIETARY

38 OMNISTIM® 500A USER MANUAL

LVPC CUSTOM:

LVPC protocol which can be customized by the therapist.

PARAMETER DEFAULT VALUES

Phase duration: 200 µS 30 µS – 500 µS Pulse rate: 100 Hz .0 Hz to 999 Hz Phase duration mod: 0 % 0 – 50% Modulation time: 0 seconds 0 – 20 seconds Modulation: OFF ON or OFF Auto Intensity: 20 % 0 – 20% Treatment time: 20 minutes 0 – 99 minutes Channel B delay: 0.0 seconds .0 – 9.9 seconds Ramp up: 2 seconds .0 – 9.9 seconds Ramp down: 2 seconds .0 – 9.9 seconds Time on: 5 seconds 1 – 30 seconds Time off: 30 seconds 0 – 199 seconds

Channels A/B: SIMULTANEOUS Waveform: Asymetric Biphasic

Output: 0 mA 0 – 99 mA

RANGE OF USER

ADJUSTABLE VALUES

B DELAYED, ALTERNATE

or SIMULTANEOUS

2. Adjustable Parameters

Pushing the set button during operation brings up the available adjustable parameters. These may be altered during system operation. To adjust any parameter simply push the parameter set button at any time during operation. This will display a parameter which may be changed. Repeated pushing of the parameter set button will continue to display parameters one at a time until all parameters have been displayed. To change the parameter use the timer/parameter set rocker switch on the front panel to increase, decrease or

ON-OFF RAMPS: Independently adjustable from 0 to 9.9 seconds

change the value of the parameter.

PULSE RATE: Adjustable from .1 - 999 Hz PHASE DURATION: Adjustable from 10 to 500 microseconds. PHASE DURATION MODULATION: +/- 20% for a five second sweep time. Select on or off.

ON - OFF TIME: On time adjustable from 0 - 30 seconds, Off time adjustable from 0 -199 seconds. CHANNEL TIMING: Simultaneous, alternate or B channel delayed. DELAY MODE: Adjustable from 0-9.9 seconds AUTO INTENSITY: Adjusts the output during treatment automatically from 0 to20% user programmable.

LOW VOLTAGE PULSED CURRENT WAVEFORM

LVPC is generally used for surface and smaller muscle stimulation and pain control with TENS technique.

CONFIDENTIAL AND PROPRIETARY

OMNISTIM® 500A USER MANUAL 39

High Volt Pulsed Current HVPC

1. Treatment Programs

The HVPC mode contains two pre-programmed modes and a custom program which may be programmed and saved by the user. The custom program will remain as long as the batteries remain charged or are not removed. All parameters may be varied during operation. The following programs are available in HVPC mode:

HVPC SENSORY:

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 minutes to 2 hours. Fast onset of relief usually within 20 minutes. Increased circulation through target tissue.

PARAMETER DEFAULT VALUES

IP interval: 100 µS 10 µS - 250 µS Pulse rate: 125 Hz .0 Hz to 125 Hz Auto Intensity: 10 % 0 – 20% Treatment time: 20 minutes 0 – 99 Minutes Ramp up: Ramp down: Time on: Time off: Waveform: Monophasic Output: 0 V 0 – 250 V

EDEMA – MUSCLE PUMP:

Activation of muscle, causing contraction of the agonist to move the joint. The muscle pump action compresses fluids into the venous and lymphatic return, while improving blood flow to the edematous tissue.

PARAMETER DEFAULT VALUES

IP interval: 100 µS 10 µS - 250 µS Pulse rate: 50 Hz .0 Hz to 125 Hz Auto Intensity: 0% 0 – 20% Treatment time: 20 minutes 0 – 99 Minutes Ramp up: 2 seconds .0 – 9.9 seconds Ramp down: 2 seconds .0 – 9.9 seconds Time on: 4 seconds 1 – 30 seconds Time off: 12 seconds 0 – 199 seconds Waveform: Monophasic Output: 0 V 0 – 250 V

RANGE OF USER

ADJUSTABLE VALUES

RANGE OF USER

ADJUSTABLE VALUES

CONFIDENTIAL AND PROPRIETARY

40 OMNISTIM® 500A USER MANUAL

2. Adjustable Parameters

Pushing the set button during operation brings up the available adjustable parameters. These may be altered during system operation. To adjust any parameter simply push the parameter set button at any time during operation. This will display a parameter that may be changed. Repeated pushing of the parameter set button will continue to display parameters one at a time until all parameters have been displayed. To change the parameter use the timer/parameter set rocker switch on the front panel to increase, decrease or change the value of the parameter.

Adjustable Parameters PULSE RATE: Adjustable from .1 - 125 Hz INTERPHASE INTERVAL: Adjustable from 10 to 250 microseconds. ON - OFF RAMPS: Adjustable from 0 to 9.9 sec ON - OFF TIME: On time adjustable from 0-30 seconds, off time adjustable from 0-199 seconds AUTO INTENSITY: Adjusts the output during treatment automatically from 0 to 20% user programmable.

HIGH VOLTAGE PULSED CURRENT WAVEFORM: Continuous or surged operation with fully adjustable ON and OFF times and ramps allow applications of HVPC therapy. Reduction of edema, pain control, NMES and soft tissue management programs can be set up with the OMNISTIM 500’s high volt pulsed current mode.

®

0-250

VOLTS

HVPC OUTPUT

PULSE

RISE TIME

>500

NANOSECONDS

INTERPHASE

INTERVAL

100

MICROSECONDS

CONFIDENTIAL AND PROPRIETARY

OMNISTIM® 500A USER MANUAL 41

TROUBLESHOOTING

The following table lists machine problem symptoms and possible areas to check for the problem causes. If these suggested measures do not correct the machine malfunction, call your ACP customer service representative.

PROBLEM CAUSE REMEDY

• Install batteries

Unit will not power on (under battery use)

Unit will not power on (under line power use)

Display shows “LOW BATTERY” warning

Unit will not start Cannot set carrier frequency

Patient feels surging or spiking sensation

Patient cannot detect output

• No batteries

• Low batteries

• Power Supply not plugged in to the

unit of AC outlet

• Power Supply not operational

• Batteries charge is too low • Recharge batteries for future use

• No program selected • Select MODALITY/PROGRAM

• Treatment in progress • Stop treatment, adjust, and restart

• Absent, inadequate, or improper

conductive medium interface

• Lead wire(s): short or breakage

• Non-conductive or poorly conductive

electrodes

• Failure of lead wire(s), electrode(s), or conductive medium interface

• Absent or dimished sensation at stimulation site

• Failure of OMNISTIM

®

500

“HOSPITAL

GRADE”

marking on the

power plug

LED

Adapter

Figure 1 Figure 2

NOTE: When using the OMNISTIM® Output Tester, increase unit output intensity to 40 mA or higher in order to significantly illuminate the LED. Also, view the LED located at the end of the output tester directly. If viewed at an angle, the LED may be too dim to notice that it is illuminated.

• Charge or replace batteries

• Verify type and settings of batteries

• Inspect battery contacts and setting per

procedure below

• Verify Power Supply is connected as appropriate

• Verify AC outlet is functional

• Verify power plug used is appropriate and

undamaged (see figure 2 below)

• Inspect Power Supply operation per procedure below

• Replace with correct and adequate conductive medium

• Test lead wire(s) and replace if necessary

• Remove electrode(s) and replace if necessary

®

• Use OMNISTIM if unit has failed or is operating incorrectly. Plug the Output Tester into the Adapter. Turn on the OMNISTIM®. Increase output intensity. If LED illuminates properly, test lead wire(s) and electrode(s) and replace if necessary (see figure 1 below). If LED is not illuminated, contact ACP at (800) 350-1100 about replacing the unit.

• Change electrode location. Perform sensory testing of the skin under the electrode site.

Output Tester to determine

Output Tester

CONFIDENTIAL AND PROPRIETARY

42 OMNISTIM® 500A USER MANUAL

INSPECT BATTERY CONTACTS / VERIFY BATTERY SWITCH SET TO RECHARGEABLE

1. Remove batteries if they are installed.

2. Inspect the battery contacts for any corrosion or discoloration. If corrosion or discoloration is found, perform the

following steps to clean the metal contacts:

• Remove the power cord from the stimulator unit.

• Hold the metal contact plate in place with one finger.

• Use a small piece of sand paper to clean the surface of the metal contact thoroughly as needed. (Figure 3).

Cleaning the battery

contact (piece of sand

paper shown)

Figure 3

3. Verify the switch inside the battery compartment is set to the RECHARGEABLE BAT. Position (assuming

rechargeable batteries are being used, which is recommended).

4. Install the rechargeable batteries into the unit.

5. Verify the battery door opens and closes correctly. The door should lock into place when closed.

INSPECT POWER SUPPLY OPERATION

1. Connect the power cord to the power supply and then to a power outlet.

2. Connect the power supply cable to the stimulator unit (Figure 4).

Connect

power supply

cable to

stimulator

Figure 4

CONFIDENTIAL AND PROPRIETARY

OMNISTIM® 500A USER MANUAL 43

3. Press the power supply switch ON (if applicable, Figure 5a).

NOTE: Newer power supply model does not have a ON/OFF switch (Figure 5b).

Press power

Figure 5a Figure 5b

supply

switch ON

4. Verify the CHARGE light is on or blinking (Figure 6).

5. Power on the stimulator and verify that you hear a click of the safety circuit relay energizing.

Charge light

For reference only: Charge light solid

progress. Charge light blinks slowly

charging completed. Charge light flickers (blinks

rapidly) - batteries not installed or are not charging properly.

- charging in

-

Figure 6

Service Center

For repair or service of ACP Products and accessories, please call (800) 350-1100 and follow the prompts. Normal hours of operation are 7:00am to 5:00pm Pacific Standard Time. After hours, please leave a message and a technician will return your call during the next scheduled workday.

CONFIDENTIAL AND PROPRIETARY

44 OMNISTIM® 500A USER MANUAL

TECHNICAL SPECIFICATIONS

GENERAL:

Dimensions:

Weight (including batteries):

Operating Power:

Battery Life:

Display System:

Push Buttons:

System Memory:

System Architecture:

STIMULATION SYSTEM:

Output:

Output Waveform:

Channel Isolation:

Line Leakage:

IFC MODES:

Frequency Difference Rate:

Full Field Burst Rate:

Rate Scan:

Vector:

MFAC MODE:

9.5" (24cm) W x 6.5" (16.5cm) D x 3" (7.6cm) H

3lbs. 14oz. (1.75 kgs)

120/240VAC; 50/60Hz; 50W 4 x 1.5VDC “D” cell alkaline or rechargeable batteries.

New alkaline batteries operate the system for 40 hours at full output and over 100 hours at normal settings. Battery voltage is displayed and monitored. With the 4.4AH NiCad rechargeable cells the system will operate approximately 10 hours at normal settings.

Super Twist LCD full character display with adjustable contrast /viewing angle.

Conductive rubber with excellent tactile feel. Speed and sensitivity are fully adjustable.

The system remembers all prior custom settings from treatment to treatment in active battery powered RAM memory. (Must be reset if the batteries are changed or discharged.)

CMOS integrated micro-controller with on board memory and instruction set.

Constant voltage up to maximum preset current limit

AC sine wave into physiologic load, IFC and MFAC modes, and biphasic square wave (LVPC) or monophasic pulsed current (HVPC mode). Output Amplitude: IFC FD and NMES modes-0 to 70 mA RMS current into a 500Ω, LVPC mode 75mA P-P, HVPC mode 250VDC peak into 500Ω loads.

Independent transformer isolation.

<50 µA when operated with the charger system.

Output channel A, fixed at 2KHz, 2.5KHz, 4KHz or 5KHz. Output channel B variable from channel A frequency + 0.0 to 250Hz. Beat rate may be set during treatment.

0.1 - 999Hz

0 - 20 seconds, 0 - 50% modulation, upper and lower frequencies are fully programmable and sweep time is adjustable in set mode.

O

Fast 90

- Scans amplitude of channel A from 0 - maximum every 10 seconds relative to channel B,

which varies concurrently out of phase.

O

Slow 90

which varies concurrently out of phase.

Fast 45

which varies concurrently out of phase.

Slow 45

which varies concurrently out of phase.

- Scans amplitude of channel A from 0 - maximum every 60 seconds relative to channel B,

O

- Scans amplitude of channel A from 50% to maximum every 10 seconds relative to channel B,

O

- Scans amplitude of channel A from 50% to maximum every 60 seconds relative to channel B,

Waveform: Burst Rate: Rate Scan:

Modified sine wave into physiologic load 2KHz, 2.5KHz, 4KHz or 5KHz carrier frequency.

Adjustable from 0.1 to 999bps, 50% duty factor

From 0-50% programmable with scan time, programmable from 0-20 seconds

CONFIDENTIAL AND PROPRIETARY

OMNISTIM® 500A USER MANUAL 45

LVPC (LOW VOLTAGE PULSED CURRENT) MODE:

Waveform: Phase Duration: Pulse Rate:

Biphasic square wave

10-500µs

0.1 - 999pps

HVPC (HIGH VOLTAGE PULSED CURRENT) MODE:

Waveform: Pulse Rise Time: Pulse Rate: Interphase Interval:

Twin monophasic pulses each with 40µs phase duration, with inter phase interval of 100µs

<500 ns

Adjustable from 1-125pps

Adjustable from 10-250µs

TIMER FUNCTIONS:

Treatment Timer: Channel Timing:

Adjustable for 1-99 minutes in one minute increments. Turns output to zero and system off and sounds 10-second buzzer to indicate completion of treatment. 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: ON Time: OFF Time:

Adjustable from 0.1 to 9 seconds in 0.1-second increments. Ramps overlap in NMES Alt mode or with channel delay

Adjustable from 1 to 30 seconds in 1-second increments

Adjustable from 0 (continuous) to 199 seconds in 1-second increments

PATIENT SAFETY SYSTEMS:

Activation:

Patient safety hand control shuts down output. Output modality may not be changed during operation. Output levels are reset to zero at the start and completion of treatment.

MISC.:

Output intensity is gradually increased during treatment from 0 to 20% automatically in a linear manner

Auto Intensity:

Treatment Programs:

Certificates and Approvals:

over the duration of the treatment when the anti-adaptation mode is selected. The amount of the increase is user programmable.

IFC: 5 Presets 1 Custom MFAC: 6 Presets 1 Custom LVPC: 7 Presets 1 Custom

HVPC: 2 Presets Devices are designed to meet or exceed all safety requirements of a medical device in its class per IEC 60601 and CSA C22.2 No. 601.1

* For program details see page 24.

Caution: Federal law restricts this device to sale by or on the order of a physician (or other health practitioner

licensed by their State).

ACP reserves the right to change technical specifications and product availability without notice.

CONFIDENTIAL AND PROPRIETARY

46 OMNISTIM® 500A USER MANUAL

OMNISTIM® 500 STANDARD AND OPTIONAL ACCESSORIES

ITEM ITEM NO. DESCRIPTION

®

OMNISTIM

MICROPROCESSER CONTROLLED

100500A

2 channels of programmable stimulation with IFC Frequency Difference Interferential, MFAC (Russian style NMES), High Volt Pulsed Current and Low Volt Pulsed Current.

Shipping Weight: 5 lbs (2.3 kg)

ITEM ITEM NO. DESCRIPTION

500 MULTIMODALITY

TREATMENT SYSTEM

WPC-259B WPC-259G

WPC-238

* WPC-244

Lead Wire – Blue or Green coded plug-in, 7’ (214cm) .08 tip pin stereo plug

Lead Wire (single)- 7' (214cm) .080 tip pin

stereo plug

Bifurcated Lead Wire

PAD-10

3-Pin Lead Wire Adapter

WHN01002

LTF02702-G

WHN14401-G

Patient Safety Switch

Charger / Line Power Supply 110v

AC Line Cord - OMNISTIM

®

OTH-04-02

OMNISTIM

Output Tester

*KCS00401

OMNISTIM

Rechargeable Batteries (D size) 4400 mAh

KR-4400D

Heavy Duty Medical Grade Ni-Cd (Nickel

Cadmium)

290500

OMNISTIM

* This item is an optional accessory and is not included with the unit.

CONFIDENTIAL AND PROPRIETARY

®

Leatherette Soft Carry Case

®

#100500A Operator Manual

OMNISTIM® 500A USER MANUAL 47

Electrodes

ITEM ITEM NO. DESCRIPTION

Infection Control Supplies

ITEM ITEM NO. DESCRIPTION

ERC 2 X 2

ERC 2 X 4

ERC 3 X 5

EDC 4 X 4

1803C

1867C

1912B

2x2 Silver Backed Reusable Electrode (4 per package)

2x4 Silver Backed Reusable Electrode (4 per

package)

3x5 Silver Backed Reusable Electrode (2 per package)

4x4 Disposable Non-Gelled Electrode (for Wound Care) (25 per package)

Protective Film for Surfaces, Infection Control, 4” X 6” Perforated sheets – 600 ft/Roll

Protective Film for Surfaces, Infection Control, 12” X 14” Perforated Sheets– 600 ft/Roll

Barrier Tubing 3", 1200’/roll

GDWP

GDWT

Germicidal Disposable Wipe - Single Use Packet (50 pkt/bx)

Germicidal Disposable Wipe Tub (160/Tub)

CONFIDENTIAL AND PROPRIETARY

48 OMNISTIM® 500A USER MANUAL

LIMITED PRODUCT WARRANTY

Warranty Coverage

Accelerated Care Plus Corp., (ACP) warranty extends to any owner of the product during the warranty period for that product. Only those items returned to the ACP Service Center within the warranty period, and also within 30 days after notification to ACP of the defect, shall be eligible for repair under the product warranty. ACP may, at its

discretion, repair or replace any part(s) that prove to be defective during the warranty period

.

Warranty Exclusion

Any and all warranty coverage 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.

Warranty Period

New Equipment

New ACP equipment is warranted against defects in material and workmanship for a period of two (2) years from the date of purchase.

Refurbished Equipment

Equipment purchased specifically labeled as Refurbished equipment, is warranted against defects in material and workmanship for a period of one (1) year from the date of purchase.

Accessories

All accessories for ACP equipment are warranted against defects in material and workmanship for a period of ninety (90) days from the date of purchase.

Ultrasound transducers are warranted against defects in material and workmanship for a period of one (1) year from the date of purchase.

Crystals for ultrasound transducers have a lifetime warranty against defects in material and workmanship.

Warranty Validation

A copy of the ACP or Recognized Dealer invoice is required to verify and approve warranty coverage.

The following information needs to be provided to the ACP Customer Service Representative prior to the product being returned under warranty coverage:

 Customer Name or Account Number as it appears under the “Bill To” on the ACP or Recognized ACP

Dealer invoice.

 Invoice Date and Number  Model number, description, and serial number of equipment  Detailed description of the problem and/or issue

CONFIDENTIAL AND PROPRIETARY

OMNISTIM® 500A USER MANUAL 49

Return of Defective Products

Any product returned to the ACP Service Center under warranty coverage must have the warranty coverage validated and must receive authorization from ACP Customer Service prior to being received at the Service Center.

Shipping charges, insurance, and any other costs incurred in sending product to ACP Service Center is the responsibility of the customer and will not be refunded. ACP shall cover the shipping charges and related costs to return the unit to the customer.

ACP is not responsible for any loss or damage to the equipment prior to receipt at an 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 handling fee.

IMPORTANT:

DO NOT SHIP THE PRODUCT TO ACP SERVICE CENTER WITHOUT FIRST SECURING

AUTHORIZATION TO DO SO. EQUIPMENT SENT IN WITHOUT AUTHORIZATION FROM ACP

CUSTOMER SERVICE WILL NOT BE ACCEPTED.

CONFIDENTIAL AND PROPRIETARY

50 OMNISTIM® 500A USER MANUAL

WARRANTY REGISTRATION CARD

Company Name:

Company Address:

City/State/Zip

Telephone Number:

Date of Purchase:

Purchased from: (Recognized Dealer)

Dealer Address:

City/State/Zip:

Unit Model Number:

Unit Serial Number:

Please copy this form and mail completed registration card, and supporting documents to:

Accelerated Care Plus Corporation 4850 Joule Street Suite A-1 Reno, NV 89502

Thank you for choosing ACP, we appreciate your business.

The serial number of the equipment may be found on the label, on the underside of the unit. For your convenience, record these numbers below, and retain along with your proof of purchase, to serve as a permanent record of your purchase.

ITEM NO. DESCRIPTION SERIAL NO. PURCHASE DATE DEALER

CONFIDENTIAL AND PROPRIETARY

OMNISTIM® 500A USER MANUAL 51

APPENDIX - ILLUSTRATED OPERATIONAL SEQUENCE

Procedure for Quick Start-Up

The following procedure can be used when the treatment protocols are going to be used as pre-set in the unit, and when there is no need to modify the pre-select parameters

.

SELECTING TREATMENT MODALITY AND PROTOCOL:

When the POWER button is pressed, the following screen appears:

SELECT MODALITY/PROGRAM TREATMENT OFF

Select the desired treatment MODALITY by pressing one of the four MODALITY buttons on the far right of the

OMNISTIM

appears is the ANALGESIA – SENSORY.

®

500. In the example below, the selection is IFC. When this button is pressed, the first protocol that

ANALGESIA - SENSORY SEGMENTAL SUB ACUTE

If the IFC button is pressed again, the treatment protocols for that MODALITY (IFC) are displayed. The protocols available under IFC are: ANALGESIA – SENSORY, ANALGESIA – MOTOR, ANALGESIA/MOTOR – SENSORY, ANALGESIA SENSORY – MOTOR, ANALGESIA NERVE BLOCK, and CUSTOM.

At this time, position the electrodes on the treatment site and connect the electrodes to the lead wires.

CONFIDENTIAL AND PROPRIETARY

52 OMNISTIM® 500A USER MANUAL

Once the desired protocol is selected (in the example below, the selection is ANALGESIA – SENSORY), press the START/STOP button. The following screen is displayed:

SET OUTPUTS A – B: A: 0mA B: 0mA A

Adjust the output intensity by using the UP or DOWN buttons for OUTPUT A and OUTPUT B, as shown below:

SET OUTPUTS A – B: A: 7mA B: 7mA A

When the desired output intensity is selected based on patient sensation, press the START/STOP button to initiate the treatment. The following screen will be displayed. The treatment timer has started to count down at this point (top right part of the screen). The protocols are displayed on the top line. Second line displays the treatment output levels for both channels as well as the ON/OFF time operation (bars on the right side of display).

IFCff CONT 100Hz T 15 A: 7mA B: 7mA

A

The timer in the upper right portion of the screen will continue to count down the treatment duration. Any parameters, including output intensity and treatment time, can be adjusted during the treatment.

NOTE: Special care should be taken if parameters are adjusted during treatment. Output intensity on both channels should be decreased first prior to adjusting other parameters in order to prevent sudden changes that may result in sudden burst of output to the patient.

Treatment will stop automatically when the treatment time counts down to zero. Treatment can also be stopped at any time by pressing the START/STOP button, or thru the use of the Patient Safety Switch. Once the treatment is completed, remove the electrodes from the patient and disconnect the lead wires from the electrodes. At this point, the unit can be turned off by pressing the power button.

CONFIDENTIAL AND PROPRIETARY

OMNISTIM® 500A USER MANUAL 53

Detailed Operational Sequence

Follow this procedure for detailed instructions on adjusting parameters for selected treatment protocols.

SELECTING TREATMENT MODALITY AND PROTOCOL:

When the POWER button is pressed, the following screen appears:

SELECT MODALITY/PROGRAM TREATMENT OFF

Select the desired treatment MODALITY by pressing one of the four MODALITY buttons on the far right of the

OMNISTIM

appears is the ANALGESIA – SENSORY.

®

500. In the example below, the selection is IFC. When this button is pressed, the first protocol that

ANALGESIA - SENSORY SEGMENTAL SUB ACUTE

If the IFC button is pressed again, the treatment protocols for that MODALITY (IFC) are displayed. The protocols available under IFC are: ANALGESIA – SENSORY, ANALGESIA – MOTOR, ANALGESIA/MOTOR – SENSORY, ANALGESIA SENSORY – MOTOR, ANALGESIA NERVE BLOCK, and CUSTOM.

CONFIDENTIAL AND PROPRIETARY

54 OMNISTIM® 500A USER MANUAL

ADJUSTING PARAMETERS FOR A SELECTED TREATMENT PROTOCOL:

Once the modality and treatment protocol have been selected, the parameters for that treatment protocol can be adjusted by following the instructions below:

In the example below, the ANALGESIA NERVE BLOCK protocol was selected within the IFC modality.

ANALGESIA NERVE BLOCK LOCAL ACUTE

To adjust the parameters for the treatment protocol, press the SELECT PARAMETERS button. The first parameter is the VECTOR. The default setting is OFF, as shown below:

VECTOR OFF LOCAL ACUTE

Press the UP or DOWN arrows to adjust the VECTOR setting. The VECTOR can be set to the following: OFF, FAST 90º, SLOW 90º, FAST 45º, and SLOW 45º.

VECTOR SLOW 45º LOCAL ACUTE

CONFIDENTIAL AND PROPRIETARY

OMNISTIM® 500A USER MANUAL 55

Press the SELECT PARAMETERS button again to advance to the next parameter. The next parameter is the AUTO INTENSITY. The default setting is 10% as shown below:

AUTO INTENSITY: 10% LOCAL ACUTE

Press the UP of DOWN arrows to adjust the AUTO INTENSITY setting. The AUTO INTENSITY can be adjusted from 0% to 20%.

AUTO INTENSITY: 7% LOCAL ACUTE

Press the SELECT PARAMETERS button again to advance to the next parameter. The next parameter is TREATMENT TIME. The default setting is 10 MINS, as shown below:

TREATMENT TIME: 10MINS LOCAL ACUTE

CONFIDENTIAL AND PROPRIETARY

56 OMNISTIM® 500A USER MANUAL

Press the UP or DOWN arrows to adjust the TREATMENT TIME setting. The TREATMENT TIME can be adjusted from 0 MINS to 99 MINS.

TREATMENT TIME: 17MINS LOCAL ACUTE

Press the SELECT PARAMETERS button again to advance to the next parameter. The next parameter is the CARRIER FREQ. The default setting is 5.0 KHz, as shown below:

CARRIER FREQ: 5.0KHz LOCAL ACUTE

Press the UP or DOWN arrows to adjust the CARRIER FREQ setting. The CARRIER FREQ can be set to the following values: 5.0 KHz and 10.0 KHz.

CARRIER FREQ: 10.0KHz LOCAL ACUTE

CONFIDENTIAL AND PROPRIETARY

OMNISTIM® 500A USER MANUAL 57

SETTING TREATMENT OUTPUTS:

Once the protocol has been selected, the parameters adjusted per treatment requirements, and the electrodes placed on the patient, the treatment outputs can be adjusted per the directions below

Once the parameters are adjusted, press the START/STOP button once. The display, depending on the length of time lapsed from parameter adjustment to pressing the START/STOP button, will show one of the two following screens:

1. If the START/STOP button is pressed immediately after parameter adjustment, the screen will show the protocol selected (in this example, ANALGESIA NERVE BLOCK). If this screen is displayed, press START/STOP again to get to the second screen (#2 below).

ANALGESIA NERVE BLOCK LOCAL ACUTE

2. If the START/STOP button is pressed after a few seconds delay following modifying of the protocols (5 or more seconds), or after pressing START/STOP again after the screen in #1 above, the following screen will be displayed.

SET OUTPUTS A – B: A: 0mA B: 0mA A

NOTE: At this point, the protocol parameters can be adjusted again, if desired. To adjust the parameters, press the

SELECT PARAMETERS button until the desired parameter to be modified is displayed. Press the TIME PARAMETER UP or DOWN arrows to modify that parameter.

CONFIDENTIAL AND PROPRIETARY

58 OMNISTIM® 500A USER MANUAL

Adjust the output intensity by using the UP or DOWN buttons for OUTPUT A and OUTPUT B, as shown below:

SET OUTPUTS A – B: A: 7mA B: 7mA A

When the desired output intensity is selected based on patient sensation, press the START/STOP button to initiate the treatment. The following screen will be displayed. The treatment timer has started to count down at this point (top right part of the screen). The protocol parameters, as modified, are displayed on the top line. Second line displays the treatment output levels for both channels as well as the VECTOR operation (bars on the right side of display).

IFC 5.0KHz T 15 A: 7mA B: 7mA A

The timer in the upper right portion of the screen will continue to count down the treatment duration. Any parameters, including output intensity and treatment time, can be adjusted during the treatment.

NOTE: Special care should be taken if parameters are adjusted during treatment. Output intensity on both channels should be decreased first prior to adjusting other parameters in order to prevent sudden changes that may result in sudden burst of output to the patient.

Treatment will stop automatically when the treatment time counts down to zero. Treatment can also be stopped at any time by pressing the START/STOP button, or thru the use of the Patient Safety Switch. Once the treatment is completed, remove the electrodes from the patient and disconnect the lead wires from the electrodes. At this point, the unit can be turned off by pressing the power button.

CONFIDENTIAL AND PROPRIETARY

OMNISTIM® 500A USER MANUAL 59

Adjusting Global Factory Settings

When the POWER button is pressed, the following screen appears:

SELECT MODALITY/PROGRAM TREATMENT OFF

Press SELECT PARAMETER button. The BATTERY VOLTAGE parameter will appear, as shown below. This screen is for informational purposes and cannot be adjusted.

BATTERY VOLTAGE: 5.1 TREATMENT OFF

Press SELECT PARAMETERS button again to advance to the next setting. The SCREEN CONTRAST parameter will appear. The default setting is 5, as shown below:

SCREEN CONTRAST 5 TREATMENT OFF

CONFIDENTIAL AND PROPRIETARY

60 OMNISTIM® 500A USER MANUAL

Adjust the SCREEN CONTRAST setting by pressing the UP or DOWN arrow buttons, as shown below. The SCREEN CONTRAST setting can be adjusted from 0 to 50.

SCREEN CONTRAST 11 TREATMENT OFF

Press SELECT PARAMETERS button again to advance to the next setting. The BUTTON SPEED A-B parameter will appear. The default setting is 87, as shown below:

BUTTON SPEED A-B: 87 TREATMENT OFF

Adjust the BUTTON SPEED A-B setting by pressing the UP or DOWN arrow buttons, as shown below. The BUTTON SPEED A-B setting can be adjusted from 0 to 99.

BUTTON SPEED A-B: 72 TREATMENT OFF

CONFIDENTIAL AND PROPRIETARY

OMNISTIM® 500A USER MANUAL 61

Press SELECT PARAMETERS button again to advance to the next setting. The BUTTON SPEED BEAT ETC parameter will appear. The default setting is 93, as shown below:

BUTTON SPEED BEAT ETC: 93 TREATMENT OFF

Adjust the BUTTON SPEED BEAT ETC setting by pressing the UP or DOWN arrow buttons, as shown below. The BUTTON SPEED BEAT ETC setting can be adjusted from 0 to 99.

BUTTON SPEED BEAT ETC: 83 TREATMENT OFF

Press SELECT PARAMETERS button again to advance to the next setting. The BUTTON DELAY parameter will appear. The default setting is 40, as shown below:

BUTTON DELAY: 40 TREATMENT OFF

CONFIDENTIAL AND PROPRIETARY

62 OMNISTIM® 500A USER MANUAL

Adjust the BUTTON DELAY setting by pressing the UP or DOWN arrow buttons, as shown below. The BUTTON DELAY setting can be adjusted from 0 to 99.

BUTTON DELAY: 27 TREATMENT OFF

Press SELECT PARAMETERS button again to advance to the next setting. The AUDIO parameter will appear. The default setting is ON, as shown below:

AUDIO: ON TREATMENT OFF

Adjust the AUDIO setting by pressing the UP or DOWN arrow buttons, as shown below. The AUDIO setting can be adjusted to either ON or OFF.

AUDIO: OFF TREATMENT OFF

NOTE: Global Factory Settings will reset to their initial default parameters if the batteries are removed or the unit

is fully discharged. To restore the new settings follow the enclosed procedure.

CONFIDENTIAL AND PROPRIETARY

ACP Omnistim 500A User manual

Specifications and Main Features

Frequently Asked Questions

User Manual

INDICATIONS & CONTRAINDICATIONS

Indications

Contraindications

Adverse Reactions

WARNINGS & PRECAUTIONS

Warnings

Precautions

THE OMNISTIM® 500

Delivery of the OMNISTIM® 500

Introduction

Controls and Functions

Factory Settings

Battery Charger / Power Supply Operation

Operational Sequence

TREATMENT GUIDELINES

Introduction to Medium Frequency Currents

Electrode Application Techniques

Monopolar (Mono-Polar) Technique

Bipolar (Bi-Polar) Technique

Quadripolar (Quadri-Polar) Technique

Treatment Preparation

Skin Inspection

ACP Reusable Electrodes

Lead Wires

INFECTION CONTROL EQUIPMENT AND PRINCIPLES OF USE

Definitions

Universal Precautions – Body Substance Isolation

Cleaning/Disinfecting of the OMNISTIM® 500

Cleaning and Low Level Disinfection

Intermediate Level Disinfection and Barriers

Use of Barriers – Intermediate Level Disinfection

MODES OF OPERATON: Protocol Reference Sheets

STIMULATION THERAPY MODES

TROUBLESHOOTING

TECHNICAL SPECIFICATIONS

OMNISTIM® 500 STANDARD AND OPTIONAL ACCESSORIES

LIMITED PRODUCT WARRANTY

APPENDIX - ILLUSTRATED OPERATIONAL SEQUENCE