Intelect Transport Model 2782 User Manual

TABLE OF CONTENTS

Intelect® TranSport Ultrasound

FOREWORD...1-2 Product Description...1 ABOUT ULTRASOUND THERAPY...3-12 Precautionary Instructions...3 Cautions...3-4 Warnings...5-5 Dangers...6 Overview of Ultrasound Therapy...7-9 Common Terms...7-9 Description of Ultrasonic Field...9 Indications...10 Contraindications...10 Precautions...11 Potential For Burns...11 Preventing Overheating of the Sound Heads...12 Preventing Adverse Effects...12 NOMENCLATURE...13-17 UNIT SPECIFICATIONS...18 ULTRASOUND TECHNICAL SPECIFICATIONS...19-20 SETUP...21-26 Mounting the Unit on the Wall...21-23 Installing the Battery Pack...24-25 Charging the Battery Pack...26 Using the Battery Pack...26

OPERATION...27-47 Creating a User Protocol...27-28 Restoring Factory Settings...29-30 Restoring Factory Protocols...31-32 Selecting a User-Defined Protocol...33-34 Preparing the Patient’s Skin for Therapy...35 Starting, Stopping, & Interrupting Therapy...36-38 System Utilities...39-47 ACCESSORIES...48 Standard Accessories...48 Optional Accessories...48 TROUBLESHOOTING...49 Troubleshooting the Display...49 Troubleshooting Error Messages...49 MAINTENANCE...50-51 Maintaining the Intelect TranSport Ultrasound...50 Cleaning...50 Service...50 Warranty Repair/Out of Warranty Repair...51 WARRANTY...52

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FOREWORD

Intelect® TranSport Ultrasound

This manual has been written for the operators of the Intelect TranSport Ultrasound. It contains general instructions for operation, precautionary instructions, and maintenance recommendations. In order to obtain maximum life and efficiency from your Intelect TranSport Ultrasound, and to assist in the proper operation of the unit, read and understand this manual thoroughly. 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. Before administering any treatment to a patient, you should become acquainted with the operating procedures, as well as the indications, contraindications, warnings, and precautions. Consult other resources for additional information regarding the application of therapeutic ultrasound.

Product Description The Intelect TranSport Ultrasound, designed and manufactured by Chattanooga Group, offers a new dimension in portable ultrasound therapy made possible by advanced software design and digital signal processing. The result is a unit with extraordinary versatility based on simplicity of operation. The Intelect TranSport Ultrasound allows you to select a frequency of 1 or 3.3 MHz without changing applicators (excluding the 1 cm2 applicator). Sound heads are available in 1 cm2, 2 cm2, 5 cm2 and 10 cm2 and include the patent pending Electronic Signature™ feature. Duty cycle may be set at 10%, 20%, 50% or Continuous. The following features are available on the Intelect TranSport Ultrasound: ©2004 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 Chattanooga Group of Encore Medical, L.P. is strictly prohibited. This publication was written, illustrated and prepared for print by Chattanooga Group of Encore Medical, L.P. 1

FOREWORD

Intelect® TranSport Ultrasound

• Clinical Portable Battery Powered Option The Intelect TranSport Ultrasound is a truly portable ultrasound unit that does not confine you to a wall socket to operate. Dual frequency application in the clinic or on the road. • Electronic Signature™ Automatically calibrate the system to any size Intelect TranSport Ultrasound sound head. • Ergonomic Applicators A new ergonomic design that offers a 20 degree contour in the applicator hand grip. This ergonomic extra will help deliver uniform ultrasound with greater clinician comfort. • Head Warming A feature traditionally available in more expensive brands of ultrasound. This will help curb the anxiety of patients during the first moments of treatment. • Clear LCD display Guide the operator through the setup process providing continuous feedback about treatment settings. Gives you optimal visibility during attended procedures. • User Protocols User protocols allow you to set, save, and change the parameters of each program (protocol) in order to tailor it to meet your patients’ specific needs. Ten storage slots are available for user protocols.

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ABOUT ULTRASOUND THERAPY

CAUTION

Precautionary Instructions

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-

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-

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

=EXPLOSION HAZARDText with an “Explosion Hazard” indicator will explain possible safety infractions if this equipment is used in the presence of flammable anesthetics. NOTE: Throughout this manual “NOTE” may be found. These Notes are helpful information to aid in the particular area or function being described.

Intelect® TranSport Ultrasound

• Read, understand and practice the precautionary and operating instructions. Know the limitations and hazards associated with using any ultrasound device. Observe the precautionary and operational decals placed on the unit. • Do not operate this unit 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 unit should be routinely checked before each use to determine that all controls function normally; especially that the intensity control properly adjusts the intensity of the ultrasonic power output in a stable manner. Also, determine that the treatment time control actually terminates ultrasonic power output when the timer reaches zero. • 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. • Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous exposure to ultrasonic energy. • Handle the applicator with care. Inappropriate handling of the applicator may adversely affect its characteristics. • Before use, remove the yellow, plastic cap from the sound head. • Before each use inspect applicator for cracks, which may allow the ingress of conductive fluid. • Inspect treatment head, cables, and associated connectors before each use. • The Intelect battery pack is designed for use only with Chattanooga Group Intelect TranSport Stim and Ultrasound systems. • This unit should be operated in temperatures between 59 to 85°F (15 to 40°C), and transported and stored in temperatures between 20 to 110°F (7 to 43°C), with relative humidity ranging from 30% - 60%. 3

ABOUT ULTRASOUND THERAPY

Intelect® TranSport Ultrasound

CAUTION • Where the integrity of the external protective earth conductor arrangement is in doubt, equipment shall be operated from its internal electrical power source. • The battery pack should be removed when storing the unit for extended periods of time. • DO NOT disassemble, modify, or remodel the unit or accessories. This may cause unit damage, malfunction, electrical shock, fire, or personal injury. • Failure to use and maintain the Intelect® TranSport Ultrasound and its accessories in accordance with the instructions outlined in this manual will invalidate your warranty. • DO NOT remove the cover. This may cause unit damage, malfunction, electrical shock, fire, or personal injury. There are no user-serviceable parts inside the unit. If a malfunction occurs, discontinue use immediately and consult the dealer for repair service. • DO NOT permit any foreign materials or liquids to enter the unit. Take care to prevent any foreign materials including, but not limited to, inflammables, water, and metallic objects from entering the unit. These may cause unit damage, malfunction, electrical shock, fire, or personal injury. • If you have difficulty operating the unit after carefully reviewing this operator’s guide, contact your Chattanooga Group dealer for assistance. • This equipment 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 equipment on and off. Try 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 equipment 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.

! • • • •

WARNING

Always keep the sound head in constant motion. Always keep the sound head in full contact with the patient’s skin or submerged under water when setting intensity. Use ample conductive gel to ensure good coupling throughout the treatment. If needed, apply when setting intensity. Be sure to read all instructions for operation before treating a patient. 4

ABOUT ULTRASOUND THERAPY !

Intelect® TranSport Ultrasound

WARNING

• Do not drop the applicator on hard surfaces. Do not cool an overheated sound head with ice water or ice packs. Do not allow the sound head to reach maximum temperatures repeatedly. All of these conditions are likely to damage the sound head crystal. Damage resulting from these conditions is not covered under the warranty. • 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. • This device should be used only under the continued supervision of a licensed practitioner. • 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. • Federal law restricts this device to sale by, or on the order of, a physician or licensed practitioner. • Dispose of all products in accordance with local and national regulations and codes. • For continued protection against fire hazard, charge the battery pack only while installed on the Intelect TranSport Ultrasound. • This equipment 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. • Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous conditions causing damage to the battery pack or cells. • To prevent electrical shock, disconnect the battery pack from the system before attempting any maintenance procedures.

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ABOUT ULTRASOUND THERAPY

Intelect® TranSport Ultrasound

DANGER • Equipment not suitable for use in the presence of a flammable anesthetic mixture with air, with oxygen or nitrous oxide. The warning symbol for this hazard is prominently displayed on the cabinet. • DO NOT connect the unit to an electrical supply without first verifying that the power supply is the correct voltage. Incorrect voltage may cause unit damage, malfunction, electrical shock, fire, or personal injury. Your unit was constructed to operate only on the electrical voltage specified on the Voltage Rating and Serial Number Plate. Contact your Chattanooga Group dealer if the unit is not properly rated. • NiMH Batteries contain Class E Corrosive materials. In the event of battery cell rupture or leakage, handle battery pack wearing neoprene or natural rubber gloves. Contents of a ruptured or leaking battery can cause respiratory irritation. Hypersensitivity to nickel can cause allergic pulmonary asthma. Contents of cell coming in contact with skin can cause skin irritation and/or chemical burns. • Never, under any circumstances, open the battery pack housing or cells. Should an individual battery from a battery pack become disassembled, spontaneous combustion of the negative electrode is possible. There can be a delay between exposure to air and spontaneous combustion. • Charge the battery pack according to the instructions found in this manual. Never attempt to charge the battery pack on any other charging mechanism. • Use the battery pack only with the Intelect TranSport Series units. • Do not reverse the polarity of the battery pack. Doing so can increase the individual cell temperature and cause cell rupture or leakage. • Never dispose of the battery pack in fire. Never short circuit the battery pack. The battery pack may explode, ignite, leak or get hot causing serious personal injury. • Dispose of NiMH batteries according to national, state and local codes and regulations.

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ABOUT ULTRASOUND THERAPY

Intelect® TranSport Ultrasound

OVERVIEW OF ULTRASOUND THERAPY Utilizing ultrasound waves through muscle, nerve, and connective tissue has been well documented as effective in reducing pain, muscle spasms, and joint contractures. There are several items that affect the penetration of ultrasound on the target tissues. Please refer to the documentation as a reference on the appropriate frequency for your clinical needs. There are 4 sound heads available with the Intelect® TranSport Ultrasound System: 1 cm2, 2 cm2, 5 cm2, and 10 cm2. Select either 1 or 3.3 MHz frequencies for each applicator (excluding the 1 cm2 applicator). Frequency may be selected either before or during therapy.

Common Terms Applicator - The hand held assembly used to deliver ultrasonic energy. The applicator includes the sound head, transducer, and related electronics. Beam Non-Uniformity Ratio (BNR) – By nature, an ultrasound beam is not homogeneous. The BNR is a ratio of the highest intensity found in the beam field to the average intensity as indicated on the output display of the unit. This measure may not exceed 5.0:1. Because of the areas of increased intensity, the sound head is moved continuously during the treatment. Collimating (Coll)- The shape of the ultrasound beam. While neither focused nor dispersed, this ultrasound beam resembles a column when applied from the unit through the sound head. Continuous Mode – The output of the ultrasound is not interrupted during the treatment time. This mode imparts the most energy to the tissues and is used when a maximal effect is desired. (See Duty Cycle). 7

ABOUT ULTRASOUND THERAPY

Intelect® TranSport Ultrasound

OVERVIEW OF ULTRASOUND THERAPY - COMMON TERMS (continued) Coupling Media – An agent used to insure that the ultrasound is transmitted from the sound head to the tissue to be treated. Gels or lotions labeled for therapeutic ultrasound use are recommended. Duty Cycle – This is the ratio of the “On” time to “Total” time of the cycle, expressed as a percentage. The duty cycle describes the pulsed modes of ultrasound. The lower the percentage, the lower temporal average intensity. 100% is continuous ultrasound. Effective Radiating Area (ERA) – A measure of the ultrasound beam made underwater, 5 mm from the radiating surface of the sound head. The ERA is always smaller than the geometric area of the sound head, but should be as close as possible. This measurement is used to calculate the ultrasound intensity in W/cm2. Frequency (Freq) – Selectable to 1 or 3.3 MHz with the 2 cm2, 5 cm2, or 10 cm2 sound head (only 3.3 MHz is available with the 1 cm2 sound head). The lower the frequency, the longer the wavelength, and the deeper the penetration of ultrasound. Lead Zirconate Titanate – A synthetic crystal used to create the ultrasound beam by vibrating 1,000,000 (1 MHz) or 3,300,000 (3.3 MHz) times per second. This type of crystal is both durable and efficient in its functions. Power – A measure of the intensity of the ultrasound delivered to the patient. Unit of measure is watts (W). Pulse Duration – Refers to the amount of time the ultrasound is being delivered in the pulsed mode. For example, in the 20% duty cycle mode, the ultrasound is delivered for 2 msec and off for 8 msec (at 100 Hz) throughout the treatment period. Pulse Frequency – The pulse frequency is the number of pulses per second and is expressed in hertz. The available pulse frequency on the Intelect TranSport Ultrasound is 100 Hz. 8

ABOUT ULTRASOUND THERAPY

Intelect® TranSport Ultrasound

OVERVIEW OF ULTRASOUND THERAPY - COMMON TERMS (continued) Pulsed Mode – The output of the ultrasound is automatically interrupted during the treatment time. This limits the amount of energy delivered to the tissues. Sound Head – The aluminum face of the applicator that contacts the patient’s skin. It covers a transducer mechanism that converts electrical energy to mechanical energy in the form of a vibrating crystal. Ultrasound Intensity – Ultrasound power delivered to the patient expressed in total power as watts (W) or in terms of the sound head’s effective radiating area, watts per centimeter squared (W/cm2).

Description of Ultrasonic Field The spatial distribution of the radiated field is essentially a collimated beam of the ultrasonic energy having a crosssectional area of 8.5 cm2 for the 10 cm2 sound head when measured at a point 5 mm from the transducer face. The energy distribution within the radiated field is 3.0 W/cm2 maximum and it takes a generally conic shape, having decreasing intensity at progressively increasing distance from the face of the transducer. This field distribution applies for the radiation emitted into the equivalent of an infinite medium of distilled, degassed water at 30° C and with the line voltage variations in the range of 10% of the rated line voltage.

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ABOUT ULTRASOUND THERAPY Indications for Ultrasound • Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as: • Relief of pain, muscle spasms and joint contractures • Relief of pain, muscle spasms and joint contractures that may be associated with: • Adhesive capsulitis • Bursitis with slight calcification • Myositis • Soft tissue injuries • Shortened tendons due to past injuries and scar tissues • Relief of sub-chronic and chronic pain and joint contractures resulting from: • Capsular tightness • Capsular scarring

Contraindications • This device should not be used for symptomatic local pain relief unless etiology is established or unless a pain

Intelect® TranSport Ultrasound

syndrome has been diagnosed. • This device should not be used when cancerous lesions are present in the treatment area. • This device should not be used when open wounds are present in the treatment area. • This device should not be used on patients suspected of carrying serious infectious disease and or disease where it is advisable, for general medical purposes, to suppress heat or fevers. • This device should not be used over or near bone growth centers until bone growth is complete. • This device should not be used over the thoracic area if the patient is using a cardiac pacemaker. • This device should not be used over a healing fracture. • This device should not be used over or applied to the eye. • This device should not be used over a pregnant uterus. • This device should not be used on ischemic tissues in individuals with vascular disease where the blood supply would be unable to follow the increase in metabolic demand and tissue necrosis might result. 10

ABOUT ULTRASOUND THERAPY

Intelect® TranSport Ultrasound

Additional Precautions

Potential for Burns

Additional precaution should be used when the ultrasound is used on patients with the following conditions: • Over an area of the spinal cord following a laminectomy, i.e., when major covering tissues have been removed. • Over anesthetic areas. • On patients with hemorrhagic diatheses.

It is possible for ultrasound therapy to cause burns if the therapy is not performed properly. Skin burns can result from one or more of the following: • If the intensity (power) is too high. • If you are using too low a frequency. • Using a stationary technique (holding the sound head in one place). • Moving the sound head too slowly. • Treating an area with sensory nerve damage (or the loss of normal skin sensations).

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."

• Desensitized areas can be overheated or burned without the patient’s knowledge. Use extreme caution with these patients (e.g., diabetes, neural damage, etc.). • Bony prominences are especially vulnerable: they reflect sound waves and increase intensity to the periosteum.

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ABOUT ULTRASOUND THERAPY

Intelect® TranSport Ultrasound maintain good contact with the skin, the therapeutic effect of the sound waves will be reduced and the sound head may overheat.

Preventing Overheating of the Sound Heads To prevent the sound head from becoming overheated, do the following:

Patient Susceptibility

• Check to be sure proper contact is being made throughout the treatment.

Some patients are more sensitive to ultrasound output and may experience a reaction similar to a heat rash. Be sure to inspect the treatment area during and following treatment, and discontinue if an adverse reaction does occur.

• When treating in water, make sure that the sound head is completely under water. • For direct coupling, you may need to apply more conductive gel or lotion during the treatment to achieve better coupling.

Output Power Choose a lower watt setting to reduce output or select a pulsed duty cycle. Higher output levels have a greater potential for patient discomfort.

• You can also reduce the power or duty cycle during the treatment if you are treating an area where it is difficult to obtain good coupling.

Coupling Coupling is described as contact between the sound head and the treatment site and may be accomplished through the use of a coupling agent, such as gel, lotion or water (underwater treatments only). Anything used as a coupling agent must be highly conductive. Air is a very poor conductor of ultrasonic waves.

Preventing Adverse Effects Perform the following procedures to avoid the negative effects of ultrasound therapy. Sound Head Movement If movement of the sound head is too slow, the patient may feel periosteal pain characterized by a deep ache or pain. If motion is too fast, or if the sound head does not

Head Max. Temp. Disclaimer Head Max. Temp. is for the protection of the equipment, not for the protection of the patient. 12

NOMENCLATURE

Intelect® TranSport Ultrasound Sound Head

Power On/Off

LCD Intensity/Contrast Dial

LED Indicator (Output Power)

LCD Clinical Resources

Duty Cycle/Pulse Frequency (Up Arrow) Applicator Time Intensity Head Warming (Back)

Intensity Display (Enter)

Frequency (Down Arrow) Stop

Start Pause 13

NOMENCLATURE

Intelect® TranSport Ultrasound

Sound Head The aluminum face of the applicator that contacts the patient’s skin. It covers a transducer mechanism that converts electrical energy to mechanical energy in the form of a vibrating crystal. Power On/Off The Power On/Off button controls the flow of electricity to the unit. LCD The LCD (Liquid Crystal Display) allows the user to view and monitor the information displayed during ultrasound therapy. The following information is displayed on the LCD: • Frequency • Duty Cycle • Power • Treatment Time • Clinical Indications Clinical Resources Select this button to access the following functions: • Utilities • Retrieve User Protocols • Save User Protocols Use the Up and Down arrow buttons to navigate through the available options.

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NOMENCLATURE

Intelect® TranSport Ultrasound

Time Press the Up or Down arrow buttons to set total treatment time of therapy. Head Warming Select this button to warm the sound head prior to treatment. The sound head is warmed to slightly above body temperature to increase patient comfort. A small icon of a thermometer will appear, and a fan will turn on indicating that head warming is on. NOTE: The Head Warming function is only possible prior to touching the Start button initiating a treatment, and while the intensity is at 0. When the Start button is pressed, Head Warming is turned off. Also note that when the Head Warming feature is used, a small amount of ultrasound energy is being emitted. Frequency Select this button to change to a frequency of 1 MHz or 3.3 MHz. The Frequency of ultrasound determines the depth of penetration. One megahertz penetrates approximately 3 to 5 centimeters, and 3.3 megahertz penetrates less than, or equal to 2 centimeters. Both 1 and 3.3 MHz frequencies are available and can be changed throughout the course of treatment by pressing the Frequency button. Start Select Start to begin a treatment session or to accept a protocol. Pause Use this button to pause the treatment session. When pressed, the icon displays. To restart therapy, press the PAUSE button. Stop Select this button to stop a treatment session. 15

NOMENCLATURE



Intelect® TranSport Ultrasound

Intensity Display Select this button to change display from W/cm2 (Intensity) to Watts (Power). Intensity Use the Up or Down arrow to increase or decrease output power intensity. Applicator The hand held assembly used to deliver ultrasonic energy. The applicator includes the sound head, transducer, and related electronics. Duty Cycle Select this button to change to a duty cycle of 10%, 20%, 50%, or Continuous. Battery Indicator When displayed on the LCD, this symbol indicates the battery pack option is present on the Intelect® TranSport Ultrasound. This symbol also displays the charge status of the battery. LCD Intensity/Contrast Dial If the intensity of the LCD display diminishes, turn the dial until the display contrast is optimal.

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NOMENCLATURE a

Intelect® TranSport Ultrasound

Charge Indicator This symbol displays when the unit is connected to mains power and the battery pack is charging. NOTE: During battery operation, if the unit is left on, but not active, for more than five minutes, it will power off to conserve battery power. To restore power, press the Power On/Off button.

Applicator Symbols This symbol indicates that although the applicator is plugged in, no ultrasound energy (other than the ultrasound energy required to warm the sound head) is being emitted from the applicator. This symbol indicates that therapy has been started, but the sound head has become uncoupled with the patient’s skin. This symbol indicates that therapy is in progress, the sound head is adequately coupled with the patient’s skin, output is being distributed to the patient, and the applicator is functioning normally. This symbol indicates that the Pause button has been pressed, and no output is being emitted from the applicator. This symbol indicates that the applicator has been unplugged from the unit.

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SPECIFICATIONS

Intelect® TranSport Ultrasound

UNIT SPECIFICATIONS WEIGHT Standard Weight (with applicator and base) ... 5.07 lb ...(2.3 kg) Battery Pack... 1.87 lb (0.85 kg) POWER Input ...100 - 240 V - 1.0 A, 50/60 Hz 75 W Max Fuses...1.0A Time Lag (not user serviceable) Electrical Class ...CLASS I Electrical Type ...TYPE B Battery Type ...Nickel Metal Hydride (NiMH) ...(1.2V x 20 size AA)

DIMENSIONS Height (with base)...6.4 in (16.3 cm) Width (with applicator) ...11.3 in (28.8 cm) Width (without applicator)...9.4 in (23.9 cm) Depth (front to rear) ...12.9 in (32.8 cm)

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