Intelect Models 340 and 380 Stim & Combo User Manuals Rev C

ENGLISH

TABLE OF CONTENTS FOREWORD... 1 ELECTROTHERAPY... 2-4 Precautionary Instructions... 2-3 Indications Electrotherapy...4 Contraindications Electrotherapy...4 Do Not Use Electrotherapy...4 Indications Ultrasound...4 Contraindications Ultrasound...4 Do Not Use Ultrasound...4 NOMENCLATURE...5-6 SPECIFICATIONS...7-16 Unit Specifications...7 Waveform Specifications 4-Pole Interferential (IFC) & High Volt...8 Diadynamic & TENS...9-10 Microcurrent...10 Träbert 2-5 & Russian...11 VMSTM & 2-Pole Interferential (2p IFC)...12 Monophasic Rectangular Pulsed & Monophasic Triangular Pulsed . . .13 Galvanic & Galvanic Interrupted...13 Ultrasound...14 OPERATION...15-44 Operator Interface...15-16 4-Pole Interferential...17-18 2-Pole Interferential...19-20 Russian...21-22 High Volt...23-24

Intelect® 340 & 380 Stim and Combo Electrotherapy Units Ultrasound...25-26 Microcurrent...27-29 VMSTM...30-31 Combination...32 Clinical Protocol SystemTM...33-37 Pain Management...34 Muscle Contraction...35 Wound Healing...36 Ultrasound...37 Waveform & Current Library...38-44 TENS...38-39 Träbert 2-5...40 Monophasic...41-42 Galvanic...43 Diadynamic...44 MAINTENANCE...45 WARRANTY...46

FOREWORD

Intelect® 340 & 380 Stim and Combo Electrotherapy Units

This manual has been written for the owners of the Intelect 340 or 380 series of electrotherapy and combination systems. It contains general information on the operation, precautionary practices and maintenance information. In order to maximize use, efficiency and the life of your unit, please read this manual thoroughly and become familiar with the controls as well as the accessories before operating the unit. This manual contains general safety, operating, maintenance and care instructions for the owners and operators of the Intelect 340 or 380 series of electrotherapy and combination systems. Specifications put forth in this manual were in effect at the time of publication. However, owing to Chattanooga Group's policy of continual improvement, changes to these specifications may be made at any time without obligation on the part of the Chattanooga Group. Before administering any treatment to a patient, the users of this equipment should read, understand and follow the information contained in this manual 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.

Product Description The Intelect 340 and 380 are two- and four-channel electrotherapy and combination systems. The Intelect 340, a two-channel system, is available in a stimulation only or combination system. The Intelect 380, a four-channel system, is also available in stimulation only or combination. Stay current with the latest clinical developments in the field of electrotherapy and ultrasound. Observe all applicable precautionary measures for treatment. Keep informed on appropriate indications and contraindications for the use of electrotherapy and ultrasound. This equipment is to be used and sold only under the prescription and supervision of a licensed practitioner. This product is NOT FOR SALE or USE in the United States of America or any of its Territories.

©2002 Encore Medical Corporation or its affiliates, Austin, Texas, USA. Any use of editorial, pictorial or layout composition of this publication without express written consent from the Chattanooga Group of Encore Medical, L.P. is strictly prohibited. This publication was written, illustrated and prepared for print by the Chattanooga Group of Encore Medical, L.P.

1

ELECTROTHERAPY

Intelect® 340 & 380 Stim and Combo Electrotherapy Units

Precautionary Instructions

CAUTION

The precautionary instructions found in this section and throughout this manual are indicated by specific symbols. Understand these symbols and their definitions before operating this equipment. The definition of these symbols are as follows;

!

=CAUTION-

• Read, understand and practice the precautionary 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.

Text with a “CAUTION” indicator will explain possible Safety infractions that could have the potential to cause minor to moderate injury or damage to equipment.

!

=WARNING- Text with a “WARNING” indicator will explain possible Safety infractions that will potentially cause serious injury and equipment damage.

!

=DANGER-

• DO NOT operate the Intelect 340 and/or 380 when connected to any unit other than Chattanooga Group devices. DO NOT operate the unit in an environment of short-wave diathermy use. • 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.

Text with a “DANGER” indicator will explain possible Safety infractions that are imminently hazardous situations that would result in death or serious injury.

• 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. • This unit should be operated, transported and stored in temperatures between 59° F and 104° (15° C and 40° C), with Relative Humidity ranging from 30% - 60%.

=EXPLOSION HAZARDText with an “EXPLOSION HAZARD” indicator will explain possible safety infractions if this equipment is used in the presence of flammable anesthetics.

• Handle ultrasound applicator with care. Inappropriate handling of the ultrasound applicator may adversely affect is characteristics. • Before each use inspect treatment head for cracks, which may allow the ingress of conductive fluid.

NOTE:- Throughout this manual “NOTE” may be found. These Notes are helpful information to aid in the particular area or function being described.

• Inspect treatment head cables and associated connectors before each use.

2

ELECTROTHERAPY !

Intelect® 340 & 380 Stim and Combo Electrotherapy Units

WARNING

•

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

•

For continued protection against fire hazard, replace fuses only with ones of the same type and rating.

•

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.

•

This device should be kept out of the reach of children.

•

Care must be taken when operating this equipment around other equipment. Potential electromagnetic or other interference could occur to this or to the other equipment. Try to minimize this interference by not using other equipment in conjunction with it.

DANGER • Explosion hazard if Intelect 340 or 380 are used in the presence of flammable anesthetics mixture with air, oxygen, or nitrous oxide. The warning symbol for this hazard is prominently displayed on the cabinet.

• This product is NOT FOR SALE or USE in the United States of America or any of its Territories. 3

ELECTROTHERAPY

Intelect® 340 & 380 Stim and Combo Electrotherapy Units

Indications Electrotherapy:

Indications Ultrasound:

• Pain relief: release and diagnose of trigger points, tender points, chronic pain, acute pain, autonomic pain.

• Skin lesions; wounds, ulcers, scars, Dupuytren's contracture • Muscle conditions: spasm, trigger point, tender point, muscle strain, myositis

• Influence muscle tone: relax, stimulate, strengthen, and stretch muscle tissue; muscle re-education in post-surgical conditions, disuse atrophy, urinary incontinence.

• Joint conditions: capsulitis, bursitis, traumatic arthritis, osteoarthritis, rheumatoid arthritis (when not in an acute phase)

• Increase local circulation

• Certain nerve conditions

• Wound healing: stimulate local cell metabolism, iontophoresis

• Circulatory disorders

• Influence autonomic function

• Soft tissue injuries

Contraindications Electrotherapy:

Contraindications Ultrasound:

• Malignancy, tumors

• Malignancy, tumors

• Acute infection or sepsis

• Acute infection or sepsis

• Acute inflammation (caution)

• Acute inflammation (caution)

• Pregnancy

• Pregnancy

• Deep vein thrombosis, phlebitis, varices

• Deep vein thrombosis, phlebitis, varices

• Arterial disease, circulatory insufficiency

• Arterial disease, circulatory insufficiency

• Loss of sensation

• Loss of sensation

Do Not Use Electrotherapy:

Do Not Use Ultrasound:

• Over eyes

• Over eyes

• Over reproductive organs

• Over reproductive organs

• During pregnancy

• During pregnancy

• Over open epiphyses in children

• Over open epiphyses in children

• Over pacemaker

• Over pacemaker

• Over open lamina (after laminectomy; spina bifida)

• Over open lamina (after laminectomy; spina bifida)

• Over superficial endoprosthesis or metal implant

• Over superficial endoprosthesis 4

NOMENCLATURE On/Off Switch

Patient Control Cable Input

Mains Input

Intelect® 340 & 380 Stim and Combo Electrotherapy Units Ultrasound Applicator

Fuse

Treatment Time Display Amplitude Display

Ultrasound Port Main Display Operating Channels 3&4

Microcurrent Probe Port

Operating Channels 1 & 2

Patient Control Operator Interface (See Pages 15 & 16)

5

NOMENCLATURE

Intelect® 340 & 380 Stim and Combo Electrotherapy Units

On/Off Switch Used to turn the unit On or Off.

Patient Control Cable Input Used to connect the Patient Control Cable to the unit.

Mains Input This is where the main power supply is connected.

Ultrasound Applicator 5 cm2 Ultrasound Applicator with Electronic SignatureTM feature.

Treatment Time Display Displays treatment time.

Amplitude Display Displays amplitude for the respective channel selected.

Ultrasound Port Used to connect the Ultrasound Applicator to the unit. The Main Display will indicate if the applicator is connected or not.

Operator Interface Used to set the parameters of the unit for each treatment.

Patient Control Allows the patient to control certain aspects of a given treatment.

Operating Channels 1 & 2 and 3 & 4 The Intelect 340C provides two channels, on the left side of unit, for electrical stimulation and one channel of ultrasound while the 380C provides four channels of electrical stimulation, two on the left side of unit and two on the right side, and one channel of ultrasound. The Intelect 340S and 380S provide two and four channels of electrical stimulation respectively.

Microcurrent Probe Port Connection for the Microcurrent probe.

Main Display Displays parameter settings for each type of treatment.

6

SPECIFICATIONS

Intelect® 340 & 380 Stim and Combo Electrotherapy Units

UNIT SPECIFICATIONS DIMENSIONS Width... 30.5 cm Length... 35.5 cm Height... 11.7 cm WEIGHT Standard Weight... 3.0 kg (Stim) / 3.0 kg (Combo) POWER Input... 100 - 240V - 1.0A, 50/60 Hz Output... +12V, 8.3A Fuses... 1.0A Time Lag (Part Number 60087) Electrical Class... CLASS I Electrical Type... TYPE BF

0413

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SPECIFICATIONS

Intelect® 340 & 380 Stim and Combo Electrotherapy Units

WAVEFORM SPECIFICATIONS 4-Pole Interferential

High-Volt

Output Mode:... Pads

Output Mode... Pads or Probe

Carrier Frequency... 2500, 5000 and 10,000 Hz

Polarity... Positive or Negative

Beat Frequency... 0-200 Hz

Beat Frequency... 1-200 Hz

Sweep Time... 15 seconds

Cycle Time . . . 5/5, 4/12, 10/10, 10/20, 10/30, 10/50, Continuous

Sweep Low Beat Frequency... 1-200 Hz

Cycle Time Ramp Up/Down... 0-10 seconds

Sweep High Beat Frequency... 1-200 Hz

Amplitude... 0-500 Volts Peak into 500 ohm load

Scan Percentage... 0-100%

Maximum Treatment Time... 60 Minutes

Amplitude... 0-100 mA RMS into 500 ohms

Available on Channels... 1, 2, 3 4

Maximum Treatment Time... 60 Minutes Available on Channel... 1 & 2, 3 & 4

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SPECIFICATIONS

Intelect® 340 & 380 Stim and Combo Electrotherapy Units

Diadynamic waveforms

TENS (Asymmetrical biphasic rectangular pulsed current)

Output Mode... Pads Output Intensity... 0-80 mA MF Current 50 Hz half-wave rectified current with a pulse width of 10 milliseconds, pulse interval of 10 milliseconds and frequency of 50 pps DF Current 100 Hz full-wave rectified current pulse width of 10 mSec and frequency of 100 pps CP Current A modulation of the MF and DF current. Each portion of the current lasts 1 second before changing to the other current format. LP Current Current with a slow and surging alternation between two MF currents and one MF current running continuously and the second MF current surged and shifted through the first MF current. CP-iso Cortes Périods Isodynamic. This waveform is a combination of Monophasé Fixe (MF) and Diphasé Fixe (DF) waveforms. The amplitude of the MF component is Modulated to be 10% to 15% lower than the DF component. Constant current format is traditional Available on channels 1, 2, 3 and 4 Preset Diadynamic sequences are available

Output Intensity... 0-100 mA Frequency... 1-250 Hz Mode Selection... Burst, Normal, Modulation Phase Duration... Adjustable 20-400 microseconds Burst Train or burst of pulses of 0 to 10 Hz for 70 mSec duration the internal frequency of the bursts is 100 Hz, each burst contains 7 pulses. Range 0-10 Hz Modulation... Scan 100%, 80%, 60%, 40% Scan time 15 sec Normal... Standard continuous TENS CC/CV output capable Treatment Time... 0-60 minutes Available on channels... 1, 2, 3, 4

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SPECIFICATIONS

Intelect® 340 & 380 Stim and Combo Electrotherapy Units

TENS (Symmetrical biphasic rectangular pulsed current)

Microcurrent

Output Intensity... 0-100 mA

Carrier Frequency... 0.1-1000 Hz

Frequency... 1-250 Hz

Output Mode... Pads or Probe

Mode Selection... Burst, Normal, Modulation

Polarity... Positive, Negative or Alternating

Phase Duration... Adjustable 20-400 microseconds

Amplitude... 0-999µA Peak into 500 ohm load

Burst Train or burst of pulses of 0 to 10 Hz for 70 mSec duration the internal frequency of the bursts is 100 Hz, each burst contains 7 pulses. Range 0-10 Hz

Maximum Treatment Time... 60 Minutes Available on channels... 1, 2, 3, 4

Modulation... Scan 100%, 80%, 60%, 40% Scan time 15 seconds Normal... Standard continuous TENS CC/CV Treatment Time... 0-60 minutes Available on Channels... 1, 2, 3, 4

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SPECIFICATIONS

Intelect® 340 & 380 Stim and Combo Electrotherapy Units

Träbert 2-5

Russian Stimulation

Output Intensity... 0-80 mA

Output Mode... Pads

Frequency... Fixed

Carrier Frequency... 2500 Hz

Phase duration... 2 mSec fixed

Burst Frequency... 20-100 Hz

Polarity Reversal The ability to alternate polarity as a percentage of treatment time. 50% of the time at positive and 50% of the time on negative. During polarity reversal the current intensity decreases to 80% of the selected value.

Duty Cycle... 10%, 20%, 30%, 40%, 50%

Phase interval... 5 mSec fixed

CC/CV

Constant current is the traditional output format

Channel Mode... Single, Reciprocal, Co-Contract

Amplitude... 0-80 mA

Amplitude... 0-100 mA RMS, during burst, into 500 ohm load

Treatment Time... 0-60 minutes

Maximum Treatment Time... 60 minutes

Available on Channels... 1, 2, 3, 4

Available on Channels... 1, 2, 3, 4

Cycle Time... 5/5, 4/12, 10/10, 10/20, 10/30, 10/50, Continuous Cycle Time Ramp Up/Down... 0-10 seconds

11

SPECIFICATIONS

Intelect® 340 & 380 Stim and Combo Electrotherapy Units

VMSTM

2-Pole Interferential

Output Mode... Pads

Output Mode... Pads

Frequency... 1-200 Hz

Carrier Frequency... 2500, 5000 and 10,000Hz

Interphase Interval... 100 µsec

Beat Frequency... 0-200 Hz

Phase Duration... 20 - 400 µsec

Sweep Time... 15 seconds

Cycle Time... 5/5, 4/12, 10/10, 10/20, 10/30, 10/50, User Defined, Continuous

Sweep Low Beat Frequency... 1-200 Hz Sweep High Beat Frequency... 1-200 Hz

Cycle Time Ramp Up/Down... 0.5, 1, 2, 5 seconds

Cycle Time . . . 5/5, 4/12, 10/10, 10/20, 10/30, 10/50, Continuous

Channel Mode... Single, Reciprocal, Co-Contract

Cycle Time Ramp Up/Down... 0.5, 1, 2 and 5 seconds

Amplitude... 0-100 mA RMS, during burst, into 500 ohm load

Amplitude... 0-100 mA RMS into 500 ohms

CC/CV

CC/CV

Maximum Treatment Time... 60 minutes

Maximum Treatment Time... 60 Minutes

Available on Channels... 1, 2, 3, 4

Available on Channels... 1, 2, 3, 4

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SPECIFICATIONS

Intelect® 340 & 380 Stim and Combo Electrotherapy Units

Monophasic rectangular pulsed current

Galvanic

Output Mode... Pads

Amplitude... 0-80 mA

Polarity Reversal The ability to change polarity between positive, negative or polarity reversal, which is a percentage of treatment time. 50% of the time at positive and 50% of the time on negative.

Available on channels... 1, 2, 3, 4

Cycle Time . . . 5/5, 4/12, 10/10, 10/20, 10/30, 10/50, Continuous

Pulse duration... 0.10 - 500 mSec

Amplitude... 0-80 mA Treatment Time... 0-60 minutes Available on Channels... 1, 2, 3, 4

Monophasic triangular pulsed current

Galvanic Interrupted

Output Mode... Pads

Phase interval... 5-5000 mSec

Polarity Reversal The ability to change polarity between positive, negative or polarity reversal, which is a percentage of treatment time. 50% of the time at positive and 50% of the time on negative.

Amplitude... 0-80 mA

Amplitude... 0-80 mA

Available on channels... 1, 2, 3, 4

Treatment time... 0-60 minutes

Phase duration... 0.1-500 mSec

Available on channels... 1, 2, 3, 4

13

SPECIFICATIONS

Intelect® 340 & 380 Stim and Combo Electrotherapy Units

Ultrasound Frequency... 1.0 MHz, +/- 5%; 3.3 Mhz, +/- 5% Duty Cycles... 10%, 20%, 50%, Continuous Pulse Frequency... 100 Hz, 16 Hz, 48 Hz Pulse Duration... 1 mSec, +/-20%; 2 mSec, +/-20% 5 mSec, +/-20% Output Power... 10 cm2 Crystal - 0-20 Watts at 1MHz, 0-10 Watts at 3.3 MHz 5cm2 Crystal... 0-10 Watts, 1/3.3 MHz 2cm2 Crystal... 0-4 Watts, 1/3.3 MHz Amplitude... 0 to 2.5 w/cm2 in continuos mode, 0-3 w/cm2 in pulsed modes Output accuracy... +/- 20% above 10% of maximum Temporal Peak to Average Ratios: 2:1, +/1 20%, at 50% Duty Cycle 5:1, +/1 20%, at 20% Duty Cycle 9:1, +/1 20%, at 10% Duty Cycle Beam Nonuniformity Ratio... 6.0 : 1 maximum Beam Type... Collimating Effective Radiating Areas... 10cm2 Crystal - 8.5cm2, +/- 1.5 5cm2 Crystal - 4.0cm2, +/- 1.0 2cm2 Crystal - 1.8cm2, +0.2/-0.4 Maximum Treatment Time... 30 Minutes

14

OPERATION

Intelect® 340 & 380 Stim and Combo Electrotherapy Units

OPERATOR INTERFACE Enter Feature Select

Treatment Time

Back

Amplitude

Russian

2-Pole Interferential

High Volt

4-Pole Interferential

VMSTM

Microcurrent Ultrasound

Combination

Protocols and Waveform Library

Start

Pause

Stop

15

OPERATION The Intelect's main screen, also called the "Home Screen" allows the user to view parameters as they are changed as well as treatment progress.

Feature Selection Use to select a specific channel to check channel parameters. Also use for selecting specific parameters during treatment setup or to make parameter changes during treatment.

Intelect® 340 & 380 Stim and Combo Electrotherapy Units Pause Press this button to pause patient treatment. Press the “Start” button to resume treatment

Protocols and Waveform Library

Back

Press this Button to access preset protocols for Pain Management, Muscle Contraction and Wound Healing. Also access to the Waveform Library is gained by pressing this button. Additional waveforms available in the Waveform Library are; Symmetrical Biphasic TENS, Asymmetrical Biphasic TENS, Träbert 2-5, Monophasic Rectangular Pulsed, Monophasic Triangular Pulsed, Galvanic, Galvanic Interrupted, Diadynamic MF, DF, CP, LP and CP iso and Ultrasound.

Press to go back to the main screen during the parameter selection process.

Ultrasound

Enter Press when parameter is selected and when the desired changes to the setup are acceptable.

Treatment Time Press the Up or Down arrow to set the total prescribed treatment time for the patient.

Press this button to select Ultrasound only for treatment.

Microcurrent

Amplitude

Press this button to select Microcurrent waveform for treatment. Microcurrent can be administered with electrode pads or probe.

Press the Up or Down arrow to set the channel amplitude to the prescribed level for treatment.

4-Pole Interferential

Russian

2-Pole Interferential

Press this button to select Russian waveform for treatment.

High Volt Press this button to select High Volt waveform for treatment.

VMS

TM

Press this button to select VMS waveform for treatment.

Combination Press this button to select Ultrasound and Electrotherapy combination for treatment.

Start Press this button to start treatment only after all parameters have been modified as prescribed for treatment.

Stop Press this button to stop all treatment and “zero” Treatment Timer.

Press this button to select 4-Pole Interferential waveform for treatment. Press this button to select 2-Pole Interferential waveform for treatment.

Head Contact Control Ultrasound delivery will automatically be turned off and the timer will stop when throughput of the ultrasound beam drops below a certain threshold. An audible tone will alert you that ultrasound transmission has been interrupted. Ensure that the head is making good contact with the skin and that sufficient ultrasound gel has been applied. Treatment will automatically resume when optimal contact is restored. To enable or disable the head contact control audible tone, simultaneously press the Intensity Up and Start buttons. To enable or disable the head contact control timer stop function, simultaneously press the Time Up and Start buttons.

Changing LCD Intensity/Contrast Press and hold the Menu button and simultaneously press the Up or Down button. 16

OPERATION

Intelect® 340 & 380 Stim and Combo Electrotherapy Units

4-Pole Interferential (IFC) The Interferential waveform consists of two channels, each with a sinusoidal waveform; one of fixed frequency and one of variable frequency. When the four electrodes are positioned so that the two channels cross each other, the two waveforms mix within the tissue to produce a train of pulses whose frequencies and amplitude are dependent on the sweep mode, beat frequency and amplitude settings, respectively. Amplitude Modulation

Select 4-Pole Interferential FEATURE SELECT UP & DOWN ARROWS

Press the 4-Pole Interferential button.

ENTER

Press the Feature Select Down Arrow to highlight “Amp. Mod.”. Press Enter. Press the Feature Select Up or Down Arrow to highlight the desired percentage then, press Enter.

Channel Amplitude ENTER AMPLITUDE

Beat Frequency

4-Pole Interferential requires the use of both Channels 1 and 2. However the amplitude of each channel can be set independently.

Press the Feature Select Down Arrow to highlight “Beat Freq.”. Press Enter. Press the Feature Select Up or Down Arrow to highlight the desired Beat Frequency then, press Enter.

Press the Enter button to select Channel 1. Then press the Amplitude Up or Down Arrow to set amplitude. Repeat for Channel 2.

If “Variable” or “Fixed” is selected see page 18 for setting those parameters. 17

OPERATION

Intelect® 340 & 380 Stim and Combo Electrotherapy Units

4-Pole Interferential (IFC)- continued FEATURE SELECT UP & DOWN ARROWS

Carrier Frequency

Beat Frequency (Variable)

Press the Feature Select Down Arrow to highlight “Carr. Freq.”. Press Enter.

If the “Variable” Beat Frequency option is selected, press the Feature Select Down Arrow to highlight “Beat Low”. Press Enter.

Press the Press the Enter button until the desired Carrier Frequency is displayed.

Press the Feature Select Up or Down Arrow to highlight the desired Beat Low frequency then, press Enter. The available Beat Low range is 1 Hz to 200 Hz in 1 Hz increments.

ENTER

Press the Feature Select Down Arrow to highlight “Beat High”. Press Enter. Treatment Time

Press the Feature Select Up or Down Arrow to select the desired Beat High frequency then, press Enter.

Press the Treatment Time Up or Down Arrow until the desired Patient Treatment time is displayed. TREATMENT TIME

The available Beat High range is 1 Hz to 200 Hz in 1 Hz increments.

NOTE:

Beat Frequency (Fixed)

Treatment Time for 4-Pole Interferential is from 0 to 20 minutes.

If the “Fixed” Beat Frequency option is selected, press the Feature Select Down Arrow to highlight “Beat Fixed”. Press Enter. Press the Feature Select Up or Down Arrow to select the desired Beat Fixed frequency then, press Enter. The available Beat Fixed range is 0 Hz to 200 Hz in 1 Hz increments. 18