Forte CPS Series 200 & 400 STIM & COMBO User Manual

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Table of Contents Introduction...1 Features of the Forte™ CPS Electotherapy System...1 Foreword...1 Forte CPS Series Product Matrix...2 Liability Disclaimer...2 Precautionary Instructions... 2 Principles of Operation...3 Initial Setup Instructions...3 System Components...4 Patient Control Center (PCC)...4 Optional Accessories...4 System Operation...5 Operator Interface...5 Control Panel...6 Indications/Contraindications/Adverse Effects for Electrical Stimulation...12 Interferential Current... 12 Premodulated Current...13 VMS, Russian, HIVOLT...14 Microamperage Pulsed Current (Microcurrent)...15 Microcurrent Probes...16 HIVOLT Probe...16 IFC – Interferential Current (Sine Wave)...17 Quick Start...17 Detailed Treatment Procedures...18 Modifying Treatment Parameters...20 Interferential Parameter Options... 20 Technical Specifications...21 PREMOD – Premodulated (Sine Wave)...22 Quick Start...22 Detailed Treatment Procedures...23 Modifying Treatment Parameters...24 Premod Parameter Options...25 Technical Specifications...26 MICRO – Microcurrent (Microamperage Pulsed Current)...26 Quick Start...27 Detailed Treatment Procedures...28 Modifying Treatment Parameters...29 Microcurrent Parameter Options...29 Microcurrent Application with Hand Held Probe (Optional)...30 Technical Specifications...31

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RUSSIAN (Interrupted Sine Wave)...32 Quick Start...33 Detailed Treatment Procedures...34 Modifying Treatment Parameters...35 Russian Parameter Options...36 Technical Specifications...36 HIVOLT – High Volt (Monophasic Twin-Peak Pulsed Current)...37 Quick Start...37 Detailed Treatment Procedures...38 Modifying Treatment Parameters...40 HIVOLT Parameter Options...40 HIVOLT Application with Hand Held Probes (Optional)...41 Technical Specifications...42 VMS – Symmetrical Biphasic Square Wave...42 Quick Start...43 Detailed Treatment Procedures...44 Modifying Treatment Parameters...45 VMS Parameter Options...46 Technical Specifications...46 US – Ultrasound...47 Quick Start...48 Indications...48 Contraindications...49 Precautions...49 Detailed Treatment Procedures...50 Modifying Treatment Parameters...51 US Parameter Options...51 Technical Specifications...52 COMBO – Combination Therapy...53 Introduction...53 Quick Start...54 Detailed Treatment Procedures...55 Setting Up a Second Treatment...57 Quick Start...57 Clinical Protocols...59 Appendix...59 Forte CPS Two Year Limited Warranty...60 System Utilities...61 Patient Control Center...61 Maintenance Instructions...62 Screen Prompts...62 Glossary...64

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Introduction • Welcome to the Forte™ CPS • Features of the Forte CPS • Foreword • Forte CPS Series Product Matrix • Liability Disclaimer • Precautionary Instructions

Welcome to the Forte CPS The Forte CPS designed and manufactured by Chattanooga Group offers a new dimension in electrotherapy, combination and ultrasound treatments. This technology is made possible by advanced software design and digital signal processing. The result is a series of products with extraordinary versatility based on simplicity of operation. A clinical electrotherapy system should not be self-limiting in any price range; as your needs as a clinician change, so can your Forte CPS.

Features of the Forte CPS Electrotherapy System Clinical Protocol System – An efficient approach for setting up a treatment using preset parameters. The Clinical Protocol library includes over 100 presets for pain management, muscle contraction or Ultrasound. Upgradeable – The world’s only system that can be upgraded from two to four Channels or to which ultrasound can be added after purchase. Electronic Signature™ Combo Systems only – Automatically calibrates the system to any size Forte sound head. Patient Control Center – A unique method of Interferential stimulation control allowing the patient to pinpoint their stimulation needs throughout the treatment session. Easy as One-Two-Go – In two steps you are ready to start therapy: Select “Waveform” – Set “Intensity” – Select “Start.” Programmable Start-Up Presets – All power-up presets can be individually customized to meet the needs of the clinician.

Foreword This manual has been written for the owners and operators of the Forte CPS. It contains general instructions for operation, precautionary instructions and maintenance recommendations. In order to obtain maximum life and efficiency from your Forte CPS and to assist in the proper operation of the unit, read and understand this manual thoroughly and become familiar with the controls on the panel as well as the various accessories that come with the unit before operating it. This manual includes operator information and instructions for the Forte CPS Stim and/or Forte CPS Combo systems. The sections that discuss ultrasound and combination treatments apply only to the Forte CPS Combo unit. All other sections in this manual apply to both the Stim and Combo devices. To inquire about upgrading options of the Forte CPS product line, consult your Chattanooga Group representative or call 1-800-592-7329. The specifications put forth in this manual were in effect at the time of publication. However, owing to Chattanooga Group’s policy of continuous improvement, changes to these specifications may be made at any time without obligation on the part of Chattanooga Group.

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Forte™ CPS Series Product Matrix PRODUCT

200 STIM

200 COMBO

400 STIM

400 COMBO

Channels

2

2 & Ultrasound

4

4 & Ultrasound

Interferential

Channels 1 & 2

Channels 1 & 2

Channels 1 & 2 or 3 & 4

Channels 1 & 2 or 3 & 4

Premod

Channels 1 & 2

Channels 1 & 2

Channels 1, 2, 3, 4

Channels 1, 2, 3, 4

Russian

Channels 1 & 2

Channels 1 & 2

Channels 1, 2, 3, 4

Channels 1, 2, 3, 4

Microcurrent

Channels 1 & 2

Channels 1 & 2

Channels 1, 2, 3, 4

Channels 1, 2, 3, 4

VMS

Channels 1 & 2

Channels 1 & 2

Channels 1, 2, 3, 4

Channels 1, 2, 3, 4

Hivolt

Channels 1 & 2

Channels 1 & 2

Channels 1, 2, 3, 4

Channels 1, 2, 3, 4

Ultrasound

Not Available

1 & 3.3 MHz

Not Available

1 & 3.3 MHz

Combination

Not Available

Available

Not Available

Available

NOTE: The above features are not available on all units. Please note the type of Forte CPS system you are operating and reference those sections of this user manual that are applicable.

Liability Disclaimer Before administering any treatment to a patient you should become acquainted with the operating procedures for each mode of treatment available, as well as the indications, contraindications, warnings and precautions. Consult other resources for additional information regarding the application of electrotherapy.

Precautionary Instructions 1. CAUTION:

Read, understand and practice the precautionary and operating instructions. Know the limitations and hazards associated with using any electrical stimulation or ultrasound device. Observe the precautionary and operational decals placed on the unit.

2. CAUTION:

DO NOT operate the Forte CPS when connected to any unit other than Chattanooga Group devices. Do not operate the unit in an environment of short-wave diathermy use.

3. WARNING: Federal law restricts this device to sale by, or on the order of, a physician or licensed practitioner. This device should be used only under the continued supervision of a physician or licensed practitioner. WARNING: Keep electrodes separated during treatment. Electrodes in contact with each other could result in improper stimulation or skin burns. 4. CAUTION:

This unit is not designed to prevent the ingress of water or liquids. Ingress of water or liquids could cause malfunction of internal components of the system and therefore, create a risk of injury to the patient.

CAUTION:

The Ultrasound generator should be routinely checked before each use to determine that all controls function normally; especially that the intensity control does properly adjust the intensity of the ultrasonic power output in a stable manner. Also, determine that the treatment time control does actually terminate ultrasonic power output when the timer reaches zero.

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5. CAUTION:

Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous exposure to ultrasonic energy.

6. CAUTION:

This unit generates, uses and can radiate radio frequency energy, and if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. Harmful interference to other devices can be determined by turning this unit on and off or trying to correct the interference using one or more of the following: Reorient or relocate the receiving device, increase the separation between the equipment, connect the unit to an outlet on a different circuit from that to which the other device(s) are connected and/or consult the factory field service technician for help.

CAUTION:

DO NOT use sharp objects such as a pencil point or ballpoint pen to operate the buttons on the control panel as damage may result.

7. WARNING: Explosion hazard if used in the presence of flammable anesthetics. The warning symbol for this hazard is prominently displayed on the cabinet. 8. WARNING: For continued protection against fire hazard, replace fuses only with ones of the same type and rating. 9. WARNING: Make certain that the unit is electrically grounded by connecting only to a grounded electrical service receptacle conforming to the applicable national and local electrical codes. 10. WARNING: This device should be kept out of the reach of children. 11. WARNING: Dispose of all products in accordance with local and national regulations and codes.

!

DANGER:

Patients with an implanted neurostimulation device must not be treated with or be in close proximity to any shortwave diathermy, microwave diathermy, therapeutic ultrasound diathermy or laser diathermy anywhere on their body. Energy from diathermy (shortwave, microwave, ultrasound and laser) can be transferred through the implanted neurostimulation system, can cause tissue damage and can result in severe injury or death. Injury, damage or death can occur during diathermy therapy even if the implanted neurostimulation system is turned "off."

Principles of Operation • Initial Setup Instructions • System Components - Patient Control Center • Warranty Registration • Optional Accessories • System Operation - Operating Controls - Quick Start - General Setup Steps - Screen Layout

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Initial Setup Instructions Remove the Forte™ CPS unit and any additional items ordered from the carton and inspect for damage that may have occurred during shipment. Check the voltage rating on the serial decal located on the bottom of the unit. Plug the system power supply in to a 100 Volt to 220/240 Volt AC outlet, as required. DO NOT attempt to use Direct Current (DC). DO NOT attempt to use the unit if it is not properly grounded. DO NOT place unit in a location where the power cord could be tripped over or pulled out during treatment. Follow the procedures listed in the precautionary instructions located later in this section.

System Components The following accessories are included (standard) with your Forte CPS. Item

Part#

Description

1

78047

Applicator, Ultrasound 5 cm 2 (Combo Only)

2

4264

Ultrasound Gel (Combo Only)

3

12213

Lead, 120”, Red/Black 1 & 2

4

12214

Lead, 120”, Red/Black 3 & 4

5

78022

Patient Control Center

6

78082

Forte CPS Power Supply

7

78121

Forte CPS Power Cord

8

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Operator’s Manual

Patient Control Center (PCC) This accessory may be used for the following: • To alter the patient’s perception of interferential stimulation. The PCC can only be utilized with Interferential Stimulation and by one patient at a time. • The Patient Control Center can also be used as a patient interrupt switch.

Warranty Registration Complete the warranty registration card and return it to Chattanooga Group within 10 days of purchase. The warranty registration card should be filled out complete with the system serial number and serial number of the included ultrasound applicator if applicable. Warranty registration will ensure that you will not be billed for services that are covered by the warranty policy.

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Optional Accessories The following is a list of optional accessories available for the Forte™ CPS Series. Item

Part#

Description

1

78046

Applicator, Ultrasound 10 cm 2

2

78048

Applicator, Ultrasound 2 cm 2

3

79976

Microcurrent Probe Kit

4

79977

HIVOLT Probe Kit

5

10832

Strap, Nylatex, Long 2 1/2”x 48”

6

10648

Strap, Nylatex, Medium, 2 1/2”x 24”

7

10828

Strap, Nylatex, Short, 2 1/2”x 18”

8

4264

Ultrasound Gel

9

76910

Service Manual

System Operation Prior to operating the Forte CPS become familiar with the following: • Control Panel - LCD and LED displays - Modes of operation - Modes of Treatment Available • Indications / Contraindications for treatment. - Specific instructions for performing each treatment. - Clinical Protocols • System Components - Patient Control Center (PCC) - Probes - Ultrasound Applicator • Accessories

Operator Interface The operator interface consists of an illustrated control panel with light emitting diodes (LED) and a liquid crystal display (LCD). The operator is able to view parameter options on the LED and LCD readouts and make selections by touching the designated area of the control panel. The displays will provide continual information during the treatments concerning amplitude and elapsed time. Ultrasound and stimulation intensities are adjusted with control panel buttons adjacent to the corresponding LED display. The stimulation / ultrasound output can be stopped by pressing the “PAUSE” or “STOP” buttons located at the bottom of the control panel or using the Patient Control Center (PCC).

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Control Panel The Forte 200 Stim and 400 Stim do not include Ultrasound or Combo. To upgrade to Ultrasound and Combo please see your Chattanooga Group representative or call: 1-800-592-7329 or 423-870-2281.

Operating Controls 1. LCD Screen Display • Provides visual display of parameters selected during all phases of treatment set up. • Main Menu provides a constant update of available Channels as well as treatments and time remaining for Channels in use. 2. LED Channel Indicator (displayed continuously) • Displays the current Channel selected. • Information presented on the screen display, as well as treatment time and power/ intensity as related to the specific Channel selected. 3. LED Treatment Time Remaining (displayed continuously) • Displays the amount of time remaining for the Channel selected. 4. Amplitude/Output Level (displayed continuously) • Displays output intensity of the selected Channel.

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5. ENTER – Parameter Selection Control • Select this prompt to change a treatment parameter to a value other than the default setting. Preset treatment parameters will be displayed on the screen; use the up or down arrow to highlight a parameter and press ENTER. Use the up and down arrows to navigate through the list of options and press ENTER to accept. • When using Clinical Protocols, use the selection control to navigate through the options. 6. Main Menu/ Escape • Select this prompt to return to the Main Menu or escape from a pop-up menu. 7. Treatment Time Controls • Select this prompt to set or modify treatment time in minutes. 8. Power/Intensity Control • Select this prompt to set or modify output intensity or amplitude. 9. Waveform Selection Buttons • IFC - Interferential Stimulation: This mode of therapy, delivered with two Channels and four electrodes, includes the Chattanooga Group unique (Quad Balance) Patient Control Center, for easy location of the treatment area. Choose the high frequency range, the low frequency range or both, along with Scan to deliver current to a more general area. • PREMOD - Premodulated Stimulation: Excellent for treating small areas or where the placement of four electrodes is not practical. This mode is quite versatile as it offers a premodulated interferential current using one Channel and two electrodes. You may choose to set up two separate premodulated treatments at the same time using two Channels. • RUSSIAN - Russian Stimulation: Through this mode, you can deliver muscle stimulation treatments choosing from a list of options including Single, Reciprocal and Co-Contraction. Choose from various cycle times and ramp times or customize the burst frequency. • HIVOLT - High Volt Stimulation: The Forte Twin-Peak HIVOLT is designed to deliver very short duration pulses, which are very low in charge or power output. Treatment can be administered using either pads or probes. Intensity displayed in Volts or Peak Current, to aid in documentation. • MICRO - Microcurrent Stimulation: Deliver Microcurrent using hand-held probes for manual attended treatment or two electrodes. You may choose to modify the frequency, polarity and intensity. • VMS - Symmetrical Biphasic Square waveform: Symmetrical biphasic rectangular pulse with interphase interval between the positive and negative phase. This waveform can be administered in Single, Reciprocal or Co-Contraction cycle times. Convenient presets can easily be altered for each patient need. • US - Ultrasound Therapy: (Combo units only) The Forte CPS gives you the choice of 1 or 3.3 MHz frequency output. Ultrasound applicators are available in 2 cm 2, 5 cm 2 and 10 cm 2 and include the Electronic Signature feature. Duty cycle may be set at 10%, 20%, 50% or Continuous. • COMBO - Combination Therapy: (Combo units only) This option allows you to combine ultrasound therapy with Premodulated, Interferential, VMS or High Volt stimulation. The ultrasound head becomes one half of the electrical circuit. You can also select from the available options for both modalities used during a given treatment.

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10. Constant Current (CC) or Constant Voltage (CV) - Output is available on Premod, VMS™, VMS™ Burst (CPS equilivants) and Russian current only. These waveforms are commonly used to elicit a muscle contraction and clinically one may wish for current output to be in either format. High Volt and IFC are set on CV and Microcurrent on CC without the ability to change this setting. Constant Current (CC) - The output waveform maintains its set current amplitude level as prescribed by the clinician. If resistance increases during a treatment, the unit will automatically increase the voltage to maintain the current amplitude. The CC setting is commonly used when a goal of the selected waveform is to elicit a muscle contraction. When CC is selected, the clinician needs to monitor the skin and be sure good electrode contact is made throughout the course of therapy as any change in electrode contact or the conducting medium will cause the voltage and current density to increase. Self-adhesive electrodes are recommended when CC is selected. Constant Voltage (CV) - If the output waveform encounters resistance, the set voltage remains the same, causing the current amplitude to decrease. The CV setting is commonly used when a goal of therapy is traditional pain management or sensory level stimulation. With Constant Voltage, as changes in electrode contact or levels of impedance increase during the course of therapy, the output level can decrease, potentially limiting the desired physiologic effect. 11. Clinical Protocol System • Select Clinical Protocol button to access the internal library of over 100 preset parameters. • Presets are grouped by pain management, muscle contraction or ultrasound. • Use the up or down arrow keys to navigate through the preset library. 12. Output Pause Control • Select this prompt to pause a treatment session. 13. Output Stop Control • Select this prompt to stop a treatment session. 14. Output Start Control • Select this prompt to begin a treatment session.

General Setup Steps The unique design of the front panel allows you to setup a treatment faster than ever. Careful grouping of treatment options allows you to easily identify and select from the appropriate option. Two simple steps are all that is needed prior to pressing START and initiating treatment.

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Quick Start The following is a general quick step by step procedure for using the Forte™ CPS. Before proceeding refer to the cautions related to the mode of use selected. Procedure

Comments

Turn power on

The unit will go through self diagnostics, followed by the main menu.

Prepare treatment site

Follow steps in preparation for treatment.

Position electrodes or apply Ultrasound gel Secure electrodes in the area to be treated Select Mode of use

Select Waveform, Ultrasound or Combo.

Set “Intensity”

Set intensity of the Channel(s) selected.

Press “Start”

To begin treatment.

End treatment

Turn power off and remove electrodes and inspect treatment area or remove residual gel.

Screen Layout There are three types of screen displays: Main Menu, Active Parameter Display and Parameter Change screens. Each of these screens is formatted for easy navigation. 1. Main Menu The Main Menu serves as the opening screen when the unit is first powered-up. It will display available Channels as well as basic text help at the bottom of the screen to prompt you to action. The Main Menu will reappear after you have initiated a treatment providing a status of the Channels in use and available, waveforms selected and elapsed treatment time.

2. Active Parameter Display Screen Active Parameter Display Screen: When a waveform is selected for use, that waveforms preset parameters will be displayed on the LCD. Basic text help is displayed at the bottom to prompt the user to action. 3. Parameter Change Screen Parameter Change Screen: In this example, moving the highlight bar to Beat Frequency and pressing ENTER will display the available Beat Frequency parameter options. Moving the highlight bar to Fixed Frequency and pressing ENTER will display the Fixed Frequency change box.

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Parameter Change Box and Display of Inactive Parameters. The once Inactive Beat Fixed option is active highlighted with a change box surrounding its preset value of 100 Hz. At this point the user can modify this value using the up or down arrow keys. After making a modification you must press ENTER to validate the change. NOTE: This same sequence of active and inactive parameter options and change sequences is repeated for all waveforms.

Parameter Adjustment Each mode of treatment offers preset treatment parameters for quick set up. Refer to individual sections for descriptions of preset treatment parameters. Change the presets to match your own most common treatment protocols or utilize the internal library of Clinical Protocols. Refer to Clinical Protocol section for more information concerning Clinical Protocols.

Parameter adjustment ranges for pain modulation modes of stimulation. Interferential

Premodulated

Microcurrent

Function

Electrodes

Electrodes

Electrodes, Probes

Carrier Frequency

5000 Hz

5000 Hz

N/A

Beat Frequency

0-200 Hz

0-200 Hz

0.1-1000 Hz

Scan Mode

On/Off

N/A

N/A

Scan Time

15 sec

N/A

N/A

Sweep Time

15 sec

15 sec

N/A

Quadrant Balance

Patient Control Center

N/A

N/A

Duty Cycle

N/A

Continuous, 5/5

N/A

Ramp Up/Down

N/A

N/A

1 sec. (+/- only)

Cycle Time

15 sec

Continuous, 5/5

N/A

Alternating Time in Polarity

N/A

N/A

2.5 sec

Polarity

N/A

N/A

+,-, +/-

Intensity CC

N/A

0-50 mA Peak

0-995 uA

Intensity CV

0-50 Volts Peak

0-50 Volts Peak

N/A

Treatment Time

1 to 60 min

1 to 60 min

1 to 60 min

N/A = Not Applicable

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Parameter adjustment ranges for muscle contraction modes of stimulation Russian

HIVOLT

VMS

Function

Electrodes

Electrodes, Probes

Electrodes

Mode

Single, Reciprocal Co-Contraction

Single, Reciprocal Co-Contraction

Single, Reciprocal Co-Contraction

Carrier Frequency

2500 Hz

N/A

N/A

Pulse Frequency

N/A

0-120 pps

5-200 pps

Burst Frequency

20-100 Hz

N/A

N/A

Phase Duration

N/A

N/A

20-300 microseconds

Interphase Interval

N/A

N/A

100 microseconds

Duty Cycle

10 - 50%

N/A

N/A

Ramp Up/Down

.5, 1, 2, 5 sec.

N/A

.5, 1, 2, 5 sec.

Cycle Time

5/5, 10/10, 10/20, 4/12, 10/30, 10/50 Continuous

5/5, 10/10, 10/20, 4/12, 10/30, 10/50 Continuous

5/5, 10/10, 10/20, 4/12, 10/30, 10/50 Continuous

Polarity

N/A

Pos.(+), Neg.(-)

N/A

Intensity CC

0-100 mA Peak

N/A

0-200 mA Peak

Intensity CV

0-100 Volts Peak

0-500 Volts Peak

0-200 Volts Peak

Treatment Time

0-60 min

0-99 min

0-60 min

N/A = Not Applicable

Parameter adjustment ranges for ultrasound mode. Function

Ultrasound

Frequency

1 MHz & 3.3 MHz

Duty Cycle

10%, 20%, 50% & Continuous

Applicator Sizes

2 cm 2, 5 cm 2 & 10 cm 2

Ultrasonic Power

Variable from 1-20 watts

Treatment Timer

0-15 min

Class I

BF

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Indications/Contraindications/Adverse Effects for Electrical Stimulation • Interferential / Premodulated - Indications / Contraindications - Warnings / Precautions / Adverse Effects • VMS, Russian, High Volt - Indications / Contraindications - Warnings / Precautions / Adverse Effects • Microcurrent - Indications / Contraindications - Warnings / Precautions / Adverse Effects • Ultrasound - Indications / Contraindications - Warnings / Precautions / Adverse Effects

Interferential Current Indications • Symptomatic relief of chronic, intractable pain. • Management of pain associated with post-traumatic or postoperative conditions. Contraindications • This device should not be used for symptomatic pain relief unless etiology is established or unless a pain syndrome has been diagnosed. • This device should not be used on patients with demand type cardiac pacemakers. • This device should not be used over cancerous lesions. • Electrode placements must be avoided that apply current to the carotid sinus region (anterior neck) or transcereberally (through the head). Warnings • The long term effects of chronic electrical stimulation are unknown. • Safety has not been established for the use of therapeutic electrical stimulation during pregnancy. • Adequate precautions should be taken when treating individuals with suspected or diagnosed heart problems or epilepsy. • Benefits of Interferential stimulation have not been established for pain of central origin. • This device is to be used as a symptomatic treatment for pain and has no curative value. Patients should be cautioned and their activities regulated if pain is suppressed that would otherwise serve as a protective mechanism. • Electronic monitoring equipment (such as ECG monitors and ECG alarms) may not operate properly when electrical stimulation is being utilized. Precautions • Isolated cases of skin rash may occur at the site of electrode placement following long term applications. The irritation may be reduced by use of an alternate conductive medium or an alternative electrode placement. • Effectiveness of this treatment is dependent upon patient selection.

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Adverse Effects • Skin irritation and burns beneath the electrodes have been reported with the use of therapeutic electrical stimulation.

Premodulated Current Indications • Symptomatic relief of chronic, intractable pain. • Management of pain associated with post-traumatic or post-operative conditions. Contraindications • This device should not be used for symptomatic pain relief unless etiology is established or unless a pain syndrome has been diagnosed. • This device should not be used on patients with demand type cardiac pacemakers. • This device should not be used over cancerous lesions. • Electrode placements must be avoided that apply current to the carotid sinus region (anterior neck) or transcereberally (through the head). Warnings • Long term effects of chronic electrical stimulation are unknown. • Safety has not been established for the use of therapeutic electrical stimulation during pregnancy. • Adequate precautions should be taken when treating individuals with suspected or diagnosed heart problems or epilepsy. • Benefits of Premodulated stimulation have not been established for pain of central origin. • This device is to be used as a symptomatic treatment for pain and has no curative value. Patients should be cautioned and their activities regulated if pain is suppressed that would otherwise serve as a protective mechanism. • Electronic monitoring equipment (such as ECG monitors and ECG alarms) may not operate properly when electrical stimulation is being utilized. Precautions • Isolated cases of skin rash may occur at the site of electrode placement following long term applications. The irritation can usually be reduced by use of an alternate conductive medium or an alternative electrode placement. • Effectiveness of this treatment is dependent upon patient selection. Adverse Effects • Skin irritation and burns beneath the electrodes have been reported with the use of therapeutic electrical stimulation.

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VMS, Russian, HIVOLT Indications • Relaxation of muscle spasms • Prevention or retardation of disuse atrophy • Increasing local blood circulation • Muscle re-education • Maintaining or increasing range of motion • Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis Contraindications • This device should not be used on patients with demand type cardiac pacemakers. • This device should not be used on cancer patients. Warnings • The long term effects of chronic electrical stimulation are unknown. • Safety has not been established for the use of therapeutic electrical stimulation during pregnancy. • Adequate precautions should be taken when treating individuals with suspected or diagnosed heart problems. • Adequate precautions should be taken in the cases of persons with suspected or diagnosed epilepsy. • DO NOT stimulate over the carotid sinus nerve, especially in persons with a known sensitivity to the carotid sinus reflex. • Severe spasm of the laryngeal and pharyngeal muscles may occur if the electrodes are placed over the neck or mouth. The contractions may be strong enough to cause breathing difficulty or even close the airway. • DO NOT perform therapeutic electrical stimulation transcerebrally (through the head). • Therapeutic electrical stimulation should not be applied over swollen, infected or inflamed areas of skin eruptions (e.g., phlebitis, thrombophlebitis and varicose veins). • Use extreme caution in transthoracic application of therapeutic electrical stimulation, introduction of electrical current into the heart may cause arrhythmia. • This device should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. • This device should be kept out of the reach of children. Precautions should be observed in the presence of the following: • Following recent surgical procedures especially when muscle contractions could disrupt the healing process. • Where sensory nerve damage is present by a loss of normal skin sensation. • When there is a tendency to hemorrhage following acute trauma or fracture. • Over the menstruating uterus. • Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or the electrical conductive medium. The irritations can usually be reduced by the use of an alternate conductive medium or alternative electrode placement. Adverse Effects • Skin irritation and burns beneath the electrodes have been reported with the use of therapeutic electrical stimulation.

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Microamperage Pulsed Current (Microcurrent) Indications • Symptomatic relief of chronic, intractable pain. • Management of pain associated with post-traumatic or postoperative conditions. Contraindications • This device should not be used for symptomatic pain relief unless etiology is established or unless a pain syndrome has been diagnosed. • This device should not be used on patients with demand type cardiac pacemakers. • This device should not be used over cancerous lesions. • Electrode placements must be avoided that apply current to the carotid sinus region (anterior neck) or transcereberally (through the head). Warnings • Long-term effects of chronic electrical stimulation are unknown. • Safety has not been established for the use of transcutaneous nerve stimulation during pregnancy. • Adequate precautions should be taken when treating individuals with suspected or diagnosed heart problems or epilepsy. • Benefits of microcurrent have not been established for pain of central origin. • This device is to be used as a symptomatic treatment for pain and has no curative value. Patients should be cautioned and their activities regulated if pain is suppressed that would otherwise serve as a protective mechanism. • Electronic monitoring equipment (such as ECG monitors and ECG alarms) may not operate properly when electrical stimulation is being utilized. Precautions • Isolated cases of skin rash may occur at the site of electrode placement, following long term applications. The irritation can usually be reduced by use of an alternate conductive medium or an alternative electrode placement. • Effectiveness of this treatment is dependent upon patient selection. Adverse Effects • Skin irritation and burns beneath the electrodes has been reported with the use of transcutaneous nerve stimulation. The microamperage current levels of this device may minimize this possibility.

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Hand Held Probes (Optional) Microcurrent Probes Active Probe (with switch) • Plug the Microcurrent probe (with switch) into the port marked Microcurrent Probe. • To deliver Microcurrent to the patient, hold the active probe as you would hold a pencil, press the button near the tip of the probe to start delivery of current. • You must also use a reference probe or a reference electrode (the Channel One Black lead wire, as described below). • The active probe should touch the patient’s skin at the treatment site and the reference probe should touch the patient’s skin elsewhere to complete the circuit. • Once you press and release the button, current will be delivered for the treatment time, which has been set in the Microcurrent parameter change screen. When the time has elapsed, a tone will sound and the device will return to the GSR mode (default). • The active/treating Microcurrent probe senses skin impedance levels when not delivering stimulation. This method of skin impedance sensing is referred to as the GSR mode. When low levels of impedance are found, the number of audible tones per second will increase. Reference Probe • The purpose of the reference probe is to complete the circuit allowing flow of current through patient tissue. The reference probe should touch the patient’s skin away from the location of the active probe. • Attach the Black wire from Channel One to the reference probe or you may use an electrode as a reference. NOTE: Place the reference device as close to the treatment site as possible where it will not interfere with placement of the active/treating electrode; for example, do not place the reference electrode on the leg if you are treating the arm. • Use the end of a (moistened) cotton swab inserted into the ends of both the active/treating probe and the reference probe. The cotton must touch the probe’s metal ring; use water to wet the cotton swab before starting the treatment.

HIGH VOLT Probe The High Volt probe is used to deliver stimulation manually. Select the High Volt Waveform then simply plug the Red lead wire into the connector of the Probe. The Black lead wire from the same Channel should be attached to an electrode and placed neat the treatment site. • Select the parameters you wish to change then press the start button to begin treatment. NOTE: Place the reference electrode as close to the treatment site as possible where it will not interfere with placement of the active electrode; for example, do not place the reference electrode on the leg if you are treating the arm.

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