Intelect Shortwave 100 User Manual

TABLE OF CONTENTS

Intelect® Shortwave 100

FOREWORD... 1 Product Description... 1 General Information... 2

Requirements for Installation... 27 Requirements for the Installation Location... 27 NOMENCLATURE... 28 Front View... 28 Rear View... 29 User Interface... 30 Software Symbols... 31 Accessories... 32 Capacitive Electrodes... 32 Flexible Rubber Electrodes... 32 Monode (Drum) Electrode... 33 Diplode Electrode... 33 Indicator Discharge Tube... 33

SAFETY INSTRUCTIONS... 4 Precautionary Definitions... 4 Cautions... 5 Warnings W ... 6 Dangers... 10 Personal Safety... 12 Protection of the Unit... 14 ABOUT SHORTWAVE DIATHERMY... 16 Overview... 16 Pulsed Shortwave Diathermy - Introduction... 16

SPECIFICATIONS... 34 Unit Specifications... 34 Operating Data and Ratings... 34 Software... 35 Transport and Storage Conditions... 35 Safety... 35 Applicator Specifications... 36 Load Resistance and Applicator Spacing... 36 Description of Device Markings... 37

INDICATIONS... 17 General... 17 CONTRAINDICATIONS... 20 General... 20 ADDITIONAL PRECAUTIONS... 24 General... 24 SETUP... 26 Unpacking the Unit... 26 Inspection... 26

OPERATION... 38 Description of Functions... 38 i

TABLE OF CONTENTS

Intelect® Shortwave 100

Introduction... 38 Applications... 38 Shortwave Diathermy in the Capacitive (Dielectric) Field... 39 Shortwave Diathermy in the Inductive Field... 40 Installing the Applicators... 41 Installing the Capacitive Electrodes... 41 Installing the Monode (Drum) Electrode... 43 Installing the Flexible Rubber Electrodes... 45 Preparing the Unit for Therapy... 46 Preparing the Patient for Therapy... 47 Basic Operation... 48 Starting Therapy... 49 Home Screen... 49 Edit Treatment Screen... 49 Electrode Screen... 50 Thermal Dosimetry... 51 Quick Link Indications... 52 Starting Therapy from the Home Screen... 52 Using the Indicator Discharge Tube... 53 Stopping, Pausing, and Completing Therapy... 54 Stopping Therapy Using the STOP Button... 54 Stopping Therapy Using the Patient Interrupt Cord... 54 Pausing Therapy... 55 Completing the Therapy Session... 55

Using Clinical Protocols... 56 Retrieving, Deleting, and Saving User Protocols... 58 Retrieving User Protocols... 58 Deleting User Protocols... 58 Saving New User Protocols... 59 Editing Existing User Protocols... 60 Using Clinical Resources - Educational Library... 61 Anatomical Graphics Library... 61 Electrode Placement Library... 62 Diathermy Rationale... 64 Contraindications... 64 Using Clinical Resources - Patient Card... 65 Patient Card... 65 Edit Pain Profile... 66 Saving Treatments to the Patient Card... 68 Erasing Patient Card... 69 Using Clinical Resources - Unit Settings... 70 Adding and Changing the Clinic Name... 70 Increasing and Decreasing the Unit Volume... 70 Setting the Date and Time... 71 Resetting Unit Settings... 71 Resetting Default Protocols... 71 Changing Languages... 72 Using the Applicators... 74 Using the Capacitive Electrodes... 74 Using the Monode (Drum) Electrode... 75 ii

TABLE OF CONTENTS

Intelect® Shortwave 100

Using the Flexible Rubber Electrode... 76 Treatment T Tips... 78 Positioning the Electrodes... 78 Positioning of Electrodes - Edge Effect... 78 Positioning of Electrodes - Edge Effect and Metal Objects... 78 Positioning of Electrodes - Electrode Constriction... 79 Positioning of Electrodes - Normal Cases... 80 Setting the Electrode - Skin Distance... 81 Dosage Levels According to Schliephake... 82

Optional Accessories... 88 W WARRANTY... 89 APPENDIX A  EMC TABLES... 90 Table 1: Guidance and Manufacturer’s Declaration– T Electromagnetic Emissions... 90 Table 2: Guidance and Manufacturer’s Declaration– T Electromagnetic Immunity... 91 Table 3: Recommended Separation Distances T between Portable and Mobile RF Communications Equipment and the Intelect Shortwave 100... 93

T TROUBLESHOOTING ... 83 Errors... 83 Error Codes and Descriptions... 83 Using the Indicator Discharge Tube... 84 MAINTENANCE... 85 Maintaining the Intelect Shortwave 100... 85 Routine Maintenance... 85 Cleaning and Disinfection... 85 Safety Inspections... 85 Service... 87 Warranty Repair/Out of Service Repair... 87 ACCESSORIES... 88 Standard Accessories... 88 iii

FOREWORD

Intelect® Shortwave 100

This manual has been written for the owners and operators of the Intelect® Shortwave 100 system. 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 Shortwave 100 system. 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 Chattanooga Group. Before administering any treatment to a patient, the user 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 shortwave diathermy.

Product Description The Intelect Shortwave 100 utilizes both inductive and capacitive electrodes to administer the clinical application of oscillating electromagnetic energy in the radio frequency of 27.12 megahertz to treat a wide variety of orthopedic and physiotherapeutic conditions. Diathermy generates deep heat within body tissues to increase circulation, decrease pain, decrease inflammation, increase ROM, influence muscle tone, and facilitate the sub acute healing phase. Stay current with the latest clinical developments in the field of shortwave diathermy. Observe all applicable precautionary measures for treatment. Keep informed on appropriate indications and contraindications for the use of shortwave diathermy. This equipment is to be used by, and sold to, a trained clinician only under the prescription and supervision of a licensed practitioner. ©2009 Encore Medical, L.P. and 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. Certain portions of this manual have been reproduced with the consent of gbo Medizintechnik AG.

1

FOREWORD

Intelect® Shortwave 100

GENERAL INFORMATION The Intelect Shortwave 100 unit and the accompanying components and individual elements fulfill, as a unit, the currently valid safety standards and comply with the stipulations of IEC 60601-1 and the medical products regulations. The unit and its external components (accessory elements) are safe if used properly and in compliance with the explanations and instructions provided in this documentation. Nevertheless, the unit or its external components can pose dangers. Therefore, we urgently recommend that anyone operating the shortwave diathermy unit become aware of the potential dangers of the unit and its external components before beginning work. Please read and observe all safety instructions in this operating manual. The following features are available on the Intelect Shortwave 100 unit:

Clear Touch Screen LCD Allows the operator to select an option on the screen by simply touching it. Guides the operator through the setup process providing continuous feedback about treatment settings. Gives the operator optimal visibility during attended procedures. Allows the operator to turn on the unit simply by pressing the LCD.

Clinical Protocols™ An efficient approach for setting up a treatment using preset parameters.

Thermal Dosimetry Allows the operator to set up a treatment using the four treatment dosages according to Schliephake (see page 82).*

*Low and Reed (1990)

2

FOREWORD

Intelect® Shortwave 100

GENERAL INFORMATION CONTINUED Quick Link Indications The Intelect Shortwave 100 incorporates a unique Quick Link Indications section which allows the user to select specific clinical indications and apply the most common therapy for the Indication selected. All modalities are editable, in their normal editing fashion, in order to customize the treatment for each patient’s prescribed therapy.

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. You may create up to 200 user protocols.

Automatic Tuning The Intelect Shortwave 100 has been programmed to automatically regulate the power between the electrodes and the patient.

Screen Saver The screen saver function acts like any other screen saver on a normal computer to reduce LCD screen burn-in. The unit will enter screen saver mode after 10 minutes of inactivity. If the user presses the touch screen or any button on the User Interface, it will return to the Home screen.

Realtime Clock The Realtime Clock keeps track of date and time even when the unit is turned off or unplugged.

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SAFETY INSTRUCTIONS

Intelect® Shortwave 100

PRECAUTIONARY DEFINITIONS 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:

Explosion Hazard Text with an “Explosion Hazard” indicator will explain possible safety infractions if this equipment is used in the presence of flammable anesthetics.

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.

Dangerous Voltage Text with a “Dangerous Voltage” indicator serves to inform the user of possible hazards resulting in the electrical charge delivered to the patient or operator in certain treatment configurations.

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

Non-ionizing Electromagnetic Radiation Text with a “Non-ionizing Electromagnetic Radiation" indicator informs the user of possible hazards resulting from elevated, potentially dangerous, levels of non-ionizing radiation.

Refer to Instruction Manual/Booklet

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

NOTE: Throughout this manual, “NOTE” may be found. These Notes are helpful information to aid in the particular area or function being described. 4

SAFETY INSTRUCTIONS

Intelect® Shortwave 100

• Inspect cables, electrodes, associated connectors, and accessories

• Read, understand, and practice the precautionary operating

before each use. To test the Patient Interrupt Cord, follow the procedures listed in "Stopping Therapy Using the Patient Interrupt Cord" on page 54. • External conductive material should be removed from the immediate treatment area. • Do not use accessories other than those supplied with the unit, or recommended by Chattanooga Group. The safety of other products has not been established, and their use could result in injury to the patient and degrade minimum safety. • Disconnect the power supply cord before removing covers on this equipment. Refer the servicing of this unit to qualified service personnel. • This equipment has an output that is capable of producing a physiological effect. • Grounding reliability can only be achieved when the equipment is connected to an equivalent receptacle marked "Hospital Only" or "Hospital Grade." • Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual.

instructions. Know the limitations and hazards associated with using any shortwave diathermy device. Observe the precautionary and operational decals placed on the unit. • DO NOT operate the Intelect Shortwave 100 in conjunction with any other devices. • DO NOT operate this unit in an environment where other devices are being used that intentionally radiate electromagnetic energy in an unshielded manner. Portable and mobile RF communications equipment can affect medical electrical equipment. • The unit should be routinely checked before each use to determine that all controls function normally, especially that the output control does properly adjust the intensity of the shortwave diathermy power output in a stable manner. Also, determine that the treatment time control does actually terminate shortwave diathermy 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. • This unit should be transported and stored in temperatures between -40 °C and 70 °C (-40 °F and 158 °F) to prevent damage to the unit or its components. • Handle shortwave diathermy accessories with care. Inappropriate handling of the accessories may adversely affect their characteristics.

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SAFETY INSTRUCTIONS

Intelect® Shortwave 100

• Since relatively high powers are used, there is the possibility of

• This unit generates, uses, and can radiate radio frequency energy

producing shock, localized burns, and cataracts if the patient is unaware of the heat due to reduced thermal sensation, or if the patient does not know what to expect during treatment. • Improper installation, operation or maintenance of the shortwave diathermy system may result in malfunctions of this unit or other devices. • In case of display failure or other obvious defects, switch the unit off immediately by means of the power switch, disconnect the power cord from the power outlet, and notify a certified service technician. • Be aware that some synthetics and plastics, though assumed to be non-conductive, may be heated by shortwave diathermy. • Adjustments or replacement of components may result in the equipment failing to meet the requirements for interference suppression. • If the unit cannot be installed immediately after delivery, the unit and its external components or accessory elements must be stored in their original packaging in a dry place. • Do not store or operate the unit in a dusty environment. • Do not cross cables. • Keep all electrodes, accessories, and their cords separated during treatment by using the cable clips located on the side of the arm extenders. Electrodes or their cords in contact with each other during treatment could result in improper stimulation, skin burns, or damage to the cord or electrode.

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 consult the factory field service technician for help. • Medical devices that are to be used within 12 meters of the Intelect Shortwave 100 should have an electromagnetic site survey completed. See NOTE 2 on page 92 for more information. • To determine the distance of separation for all equipment operating near the Intelect Shortwave 100, consult the EMC tables applicable to the other equipment. If the distance cannot be determined, make certain that the other equipment is operated from a distance of no less than 12 meters. • This equipment is to be used by, and sold to, a trained clinician only under the prescription and supervision of a licensed practitioner.

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SAFETY INSTRUCTIONS

Intelect® Shortwave 100

• Do not lean on or hold the cables during treatment. • Keep all line cords away from the diathermy unit cables. Do not

• Metal in treatment area will provide low impedance paths to the induced radio frequency current, producing local heating and the possibility of burning. In particular, treatment should never be given in the area of metal implants. Also, metal jewelry, buckles, cell phones, etc must be removed. • Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous exposure to shortwave diathermy energy. • Make certain that the unit is electrically earthed by connecting only to a earthed electrical service receptacle, conforming to the applicable national and local electrical codes. • This device should be kept out of the reach of children. • Induction field electrodes that are operated without a patient could be destroyed due to overheating. • Make certain that the electrode arms and arm extenders are locked firmly into place during shortwave diathermy therapy using the front and rear handwheels to prevent unintentional movement. See page 28 for the nomenclature of the unit. • Do not leave patient unattended during shortwave diathermy therapy.

store or coil line cords where they can come close to the cables on an operating shortwave diathermy unit. • 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. • Care must be taken when operating this unit adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Intelect Shortwave 100 should be observed to verify normal operation in the configuration in which it will be used. Potential electromagnetic or other interference could occur to this or other equipment. Try to minimize this interference by not using other equipment in conjunction with it. • Use only accessories that are specially designed for this unit. Do not use accessories manufactured by other companies on this unit. Chattanooga Group is not responsible for any consequence resulting from using products manufactured by other companies. The use of other accessories or cables (other than those specified) may result in increased emissions or decreased immunity of this unit.

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SAFETY INSTRUCTIONS

Intelect® Shortwave 100

• Remove the electrode applicator by pulling the cable connector only.

• In the event that an Error message or Warning appears beginning

DO NOT remove by pulling the cable. • To remove the cable from the applicator, make certain the power is off. While the electrode applicator is being supported by the electrode arm, hold the electrode while removing the cable to prevent the electrode from dropping to the floor. • Tighten arms so that they do not move during therapy. • Observe the patient and the position of the arms at all times during therapy. • Inform the patient that the arms are not supposed to move during therapy. • Before using the unit, verify the patient is not in contact with the unit, the electrode connection cable, the electrodes, or other devices or metal objects.

with a 2 or 3, immediately stop all use of the unit and contact the dealer or Chattanooga Group for service. Errors and Warnings in these categories indicate an internal problem with the unit that must be tested by Chattanooga Group or a Field Service Technician certified by Chattanooga Group before any further operation or use of the system.Use of a unit that indicates an Error or Warning in these categories may pose a risk of injury to the patient, user, or extensive internal damage to the system.

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SAFETY INSTRUCTIONS

Intelect® Shortwave 100

• Do not administer shortwave diathermy to a patient who

• Other equipment, including patient connected devices, may

has had an implant in the past unless you are absolutely certain that the implant and all leads in their entirety have been removed. Note that the leads are often left implanted after the implant is removed. • This unit generates non-ionizing radiation. Patients with implanted electronic devices, such as cardiac pacemakers and defibrillators, cochlear implants, bone growth stimulators, deep brain stimulators, spinal cord stimulators, and other nerve stimulators, must not be treated, even if the device has been turned off. • The function of certain implanted devices (e.g., pacemakers) may be adversely affected during treatment with shortwave diathermy. In case of doubt, the advice of a licensed practitioner in charge of the patient should be sought. • Shortwave diathermy should not be used on patients who have any implanted metallic lead or any implanted system that may contain a lead. Both the heating and non-heating modes of operation pose a risk of tissue destruction. If you are a licensed practitioner who implants or monitors patients with leads or implanted systems with leads, explain to the patient what diathermy is and stress that they should not receive shortwave diathermy treatment. If you are a licensed practitioner who uses diathermy in your practice, be sure to ask patients about possible implants before deciding to administer shortwave diathermy.

be adversely affected when in close proximity to shortwave diathermy equipment. • Patients should not be treated with shortwave diathermy when they have reduced thermal sensitivity over the proposed area of treatment, unless the physician in charge of the patient is notified. • Treatment should not be given through clothing, although it is permissible to administer treatment through a dressing or plaster in pulsed modes. • Remove hearing aids prior to treatment. • At average power levels above 5 W, patients should not be allowed to come into contact with conductive parts which are earthed or which have an appreciable capacitance to earth and which may provide unwanted pathways for the radio frequency current. In particular, treatment must never be given with the patient on metal framed couches, chairs, or beds. Do not use conductive mattresses or mattress covers. • Before increasing the output in response to a report of inadequate patient heating, verify that the cables are properly routed, spaced correctly, and away from metal or grounded objects. The heating effect may be misdirected and heating may be occurring in an unwanted area. • Before each use, check the condition of the housing and the insulation of the electrodes, electrode connection cable, and the power supply cable. Also make sure that the cables have been routed correctly.

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SAFETY INSTRUCTIONS

Intelect® Shortwave 100

• If the unit is not safe for operation, then it must be repaired

• The Electrode-Skin Distance (ESD) must be small for

by certified service personnel and the operators must be informed of the dangers posed by the unit. • In order to prevent electrical shock, unplug the power plug from the socket before cleaning or disinfecting the unit. • Under no circumstances may liquid penetrate the openings on the unit, e.g. the connecting sockets of the electrode cables. Therefore, do not use cleaning or disinfectant sprays. • The unit, electrodes, and cables may not be sterilized using steam or gas. • Never clean the unit with abrasives, disinfectants or solvents that could scratch the housing or damage the unit. • Internal burns can occur with the incorrect application of shortwave diathermy due to excessive intensity. • Internal burns can occur with the incorrect application of shortwave diathermy due to excessive exposure time. • Do not perform unauthorized repairs under any circumstances. • The unit and the electrodes must be positioned so that there is no danger of personal injury. Therefore, you must read and observe the safety instructions and the list of contraindications before putting the unit into operation.

surface warming and large for depth warming. A larger Electrode-Skin Distance (ESD) is necessary for patients with a thick layer of subcutaneous fat in order to achieve the necessary warming of deep-lying tissue. • Explosion hazard if Intelect Shortwave 100 is used in the presence of flammable anesthetics mixture with air, oxygen, or nitrous oxide. • The operator should not use diathermy over the heart in order to prevent theoretical cardiac signal interference. • Never, under any circumstances, attempt to hold any of the electrodes in your hands during therapy. • The unit must be installed so that there is no danger to the patient, the operator or other persons. Therefore, you must read the safety instruction and contraindications. • Keep all unnecessary persons out of the treatment location. No other person should be located within 3 meters of the unit. • The Intelect Shortwave 100 unit may contain Di (2ethylhexyl) phthalate (DEHP) which is the plasticizer for most PVC medical devices. Everyone is exposed to small levels of DEHP in everyday life. However, some

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SAFETY INSTRUCTIONS

Intelect® Shortwave 100

• In case of damage from transport that could endanger personal

individuals can be exposed to high levels of DEHP through certain medical procedures. DEHP can leach out of plastic medical devices into solutions that come into contact with the plastic. The amount of DEHP that will leach out depends on the temperature, the lipid content of the liquid, and the duration of contact with the plastic. As a preventative measure, use PVC devices that do not contain DEHP, or devices made of other materials such as ethylene (EVA), silicone, polyethylene, or polyurethane for all clinical procedures. Avoid using DEHP-leaching PVC when performing all clinical procedures on male neonates, pregnant women who are carrying male fetuses, or peripubertal males. • The Intelect Shortwave 100 unit may contain bisphenol-A (BPA) which is a building block of polycarbonate plastic used to make numerous consumer products (baby bottles, 5 gallon water bottles, etc). This chemical is considered an Unclassifiable Carcinogen and a suspected Endocrine disruptor which may interfere with or block hormones. BPA is highly toxic if swallowed, absorbed through the skin, or inhaled.

safety, the unit must not be connected to the Mains Power Supply before inspection is complete. • Adhere to rules, regulations, and ordinances that may vary from location to location concerning the appropriate use of high powered radio frequency fields. • Since the effects of high-frequency fields on unborn life have not yet been sufficiently researched, we recommend that operators who are pregnant are not within 15 meters of the applicator when the unit is activated. • Any persons with pacemakers or implants must remain outside of the treatment area during shortwave diathermy. No one wearing a cardiac pacemaker should be within 15 meters of an operating unit.

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SAFETY INSTRUCTIONS

Intelect® Shortwave 100

PERSONAL SAFETY

• the patient to be treated (and the personnel) have removed

In case of improper or unauthorized use of the unit, the operator, the patient or other persons may be subjected to the danger of electric shock due to high voltage produced by the unit, the danger of influence on active implantations by magnetic fields produced by the unit and the danger of being burned due to erroneously positioned electrodes or false parameters such as the duration of treatment, power output or operating mode.

all electric devices (e. g. hearing aids, electrotherapy electrodes, mobile telephones) and all conductive objects (e.g. rings, chains, watches, earrings or other jewelry, eyeglasses) and that they are not in the immediate vicinity of the unit, the patient is in a composed state and the bodily areas to be treated are dry on the exterior. • the electrodes are positioned according to the doctor’s instructions (to be checked by the doctor or physiotherapist if applied by assisting personnel). • there are no unneeded personnel in the room other than the operator and the patient. • there is no danger of unwanted local warming due to electrode constrictions. Before using the unit, speak with the patient to verify: • the patient is in a comfortable position during the entire treatment. • the patient is not in contact with the unit, the electrode connection cable, the electrodes, or other devices or metal objects. • that the patient is comfortable before and during treatment.

Before operating the unit, please read this instruction manual carefully and observe the information contained therein. Pay special attention to the list of contraindications. Refer to "Safety Instructions" on pages 5-11, "Contraindications" on pages 20-23, and "Additional Precautions" on pages 24-25. Before operating the unit each time, verify that: • the unit has been correctly connected to the Mains Power Supply. • the unit has been set up so that it is free-standing and the patient is not in direct contact with metal objects such as heating radiators, metal beds, or other equipment. • the insulation of the RF output jack and electrode connection cables is not damaged. • the electrode connection cable is connected properly and is not cross-routed (which may cause capacitive short circuits). • only accessories (cables, electrodes) approved by the manufacturer are connected. 12

SAFETY INSTRUCTIONS

Intelect® Shortwave 100

PERSONAL SAFETY CONTINUED Before using the unit, determine the maximum nominal output power of the respective accessory in order to avoid overheating the tissue. At regular intervals during the treatment, verify: • that the unit is functioning properly • that there is no moisture development* (perspiration) in the area of the electrodes • if the patient feels well.** After the treatment, ask the patient about the tolerance of the treatment. The treatment environment should be inspected by a licensed practitioner. * The affected parts of the body should be unclothed during treatment, since accumulation of moisture on the skin or in folds can cause local overheating of the skin. This is especially important in the event that the patient is wearing clothing made of moisture-resistant fabric such as silk or synthetic fibers. * *The output power must always be set according to the subjective response of the patient. Particular care is to be taken with patients who have a reduced capacity for heat perception (see the dosage levels according to Schliephake on page 82). 13

SAFETY INSTRUCTIONS

Intelect® Shortwave 100

PROTECTION OF THE UNIT Before connecting the unit, make sure that: • the voltage rating on the safety label corresponds to the available system voltage. • the frequency rating on the rating plate corresponds to the system frequency. • an earthed socket outlet with earthing contact is available for connecting the unit. • the routing of the power cable from the unit to the socket outlet with earthing contact does not pose a danger for personnel or the patient. • the Mains Power Supply is designed for the comparatively high (possibly additional) power input of the unit (~ 1500 VA) and the line is sufficiently protected in accordance with regulations.

Improper installation, operation or maintenance of the shortwave diathermy unit may result in malfunctions of this unit or other devices.

Observe the following instructions in order to prevent malfunctions: • In order to prevent electromagnetic disturbances, place the unit at least 12 meters (see the Caution on page 6 for more information) from any other devices. Also make sure that there is sufficient distance between the unit and Mains Power Supply or data cables in walls, ceilings and floors, since the electromagnetic radiation from the unit can pass these essentially without hindrance. • In selecting the location for the unit, make sure that the patient has contact during the treatment to the nonearthed application element and, due to equalizing currents in case of differing potentials, that the patient is never in contact with metal elements (especially if they are earthed), such as heating radiators, metal beds or other earthed devices.

Make certain that the unit is electrically earthed by connecting only to a earthed electrical service receptacle, conforming to the applicable national and local electrical codes.

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SAFETY INSTRUCTIONS

Intelect® Shortwave 100

PROTECTION OF THE UNIT CONTINUED • Never clean the unit with abrasives, disinfectants, or solvents

Do not connect the unit to the Mains Power Supply until the following requirements have been met: • Before putting the unit into operation, check to make sure that the electrode connection cable and the electrodes are undamaged and have been connected correctly to the unit. • Never operate the unit with open outputs, (i.e. without electrodes). • Do not operate the unit for an extended period with no load (without a patient), especially in coil (induction field) mode. When operating the unit without power output, induction field electrodes could be destroyed due to overheating. • Pay attention to the routing of the electrode connection cables. These must always be in the air and must never lie on surfaces. • Other than Chattanooga Group equipment, keep chip cards, magnetic cards, audio and video cassettes, and other data media susceptible to interference away from the unit. • Clean and disinfect the unit only when the Mains Power Supply is deactivated (power switch off, power plug disconnected). • Clean and disinfect the unit only by means of disinfection by wiping. Disinfecting by spraying can damage the unit due to penetrating moisture.

•

15

that could scratch the housing or damage the unit. Never perform unauthorized service work. All service work must be performed only by service technicians who have been authorized by the manufacturer.

ABOUT SHORTWAVE DIATHERMY

Intelect® Shortwave 100

OVERVIEW Shortwave refers to electromagnetic radiation in the frequency range 2 to 100 MHz. Shortwave diathermy is the application of electromagnetic energy to the body at shortwave frequencies. At these frequencies, the electromagnetic energy is converted to thermal energy by the induction of circulating currents in the tissue and dielectric absorption in insulating tissue. Shortwave diathermy units may produce varying output power levels providing significant heat to the area of the body being treated. To avoid equipment such as shortwave diathermy units interfering with radio communications, certain frequency ranges are designated by international agreement as ISM (Industrial, Scientific, and Medical) bands.

Pulsed Shortwave Diathermy - Introduction Pulsed shortwave diathermy equipment delivers the energy in pulses or bursts of shortwave energy. The pulses are typically 20 to 400 μsec in duration (pulse width) and are repeated with a frequency of 10 to 800 Hz (pulse frequency). As with other modalities such as ultrasound, it is found that delivering the energy in pulses is often therapeutically more beneficial than providing the same amount of energy in continuous waveform. Pulsed shortwave diathermy appears to be effective for many conditions especially in the early stages of recovery. Because the output is pulsed, the average output power levels can be very low (less than 1 W) and still produce the effective treatment. The Intelect Shortwave 100 in pulsed mode provides a peak power of 200 W and average powers from a few mW to 64 W.

Shortwave diathermy equipment normally uses the band centered on 27.12 MHz. This corresponds to a wavelength, in a vacuum, of approximately 11 meters.

As the power levels are lower than with conventional shortwave diathermy equipment, some of the potential dangers associated with the modality no longer apply.

Shortwave diathermy is normally applied at a level which produces detectable heating and the benefits are those associated with the heating effect (encouragement of healing, pain relief, reduction of muscle spasm, increase in mobility, etc.). The difference between shortwave diathermy and other methods of heating is that it provides “deep heat.” Other heating techniques such as infrared therapy, hot packs, etc., provide the heat externally whereas shortwave diathermy generates heat within the tissue. 16