Chattanooga Intelect Shortwave 100 User manual

User Manual
Operation & Installation
Instructions for:
Intelect Shortwave 100
REF 1602
Intelect Shortwave 100 (Canada)
REF 1604
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Intelect® Shortwave 100
TABLE OF CONTENTS
i
FOREWORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Product Description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
SAFETY INSTRUCTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Precautionary Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Dangers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Personal Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Protection of the Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
ABOUT SHORTWAVE DIATHERMY . . . . . . . . . . . . . . . . . . . . . 16
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Pulsed Shortwave Diathermy - Introduction . . . . . . . . . . 16
INDICATIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
CONTRAINDICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
ADDITIONAL PRECAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . 24
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
SETUP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Unpacking the Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Inspection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
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
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
OPERATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Description of Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
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Intelect® Shortwave 100
TABLE OF CONTENTS
ii
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
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Intelect® Shortwave 100
TABLE OF CONTENTS
iii
Using the Flexible Rubber Electrode. . . . . . . . . . . . . . . . . . 76
Treatment 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
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
Optional Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
WARRANTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
APPENDIX A  EMC TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Table 1: Guidance and Manufacturer’s Declaration–
Electromagnetic Emissions . . . . . . . . . . . . . . . . . . 90
Table 2: Guidance and Manufacturer’s Declaration–
Electromagnetic Immunity . . . . . . . . . . . . . . . . . . 91
Table 3: Recommended Separation Distances
between Portable and Mobile RF
Communications Equipment and the
Intelect Shortwave 100 . . . . . . . . . . . . . . . . . . . . . . 93
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Intelect® Shortwave 100
FOREWORD
1
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.
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Intelect® Shortwave 100
FOREWORD
2
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)
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Intelect® Shortwave 100
FOREWORD
3
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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Intelect® Shortwave 100
SAFETY INSTRUCTIONS
4
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:
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.
Text with a “WARNING” indicator will explain possible safety
infractions that will potentially cause serious injury and
equipment damage.
Text 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.
PRECAUTIONARY DEFINITIONS
Explosion Hazard
Text with a “DANGER” indicator will explain possible safety
infractions that are imminently hazardous situations that would
result in death or serious injury.
Text with a “Non-ionizing Electromagnetic Radiation"
indicator informs the user of possible hazards resulting
from elevated, potentially dangerous, levels of non-ionizing
radiation.
Non-ionizing Electromagnetic Radiation
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.
Dangerous Voltage
Refer to Instruction Manual/Booklet
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Intelect® Shortwave 100
SAFETY INSTRUCTIONS
5
Read• , understand, and practice the precautionary operating
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.
Inspect cables, electrodes, associated connectors, and accessories• 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.
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Intelect® Shortwave 100
SAFETY INSTRUCTIONS
6
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 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.
Since• relatively high powers are used, there is the possibility of
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.
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Intelect® Shortwave 100
SAFETY INSTRUCTIONS
7
Do not lean on or hold the cables during treatment.•
Keep all line cords away from the diathermy unit cables. Do not• 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.
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.
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Intelect® Shortwave 100
SAFETY INSTRUCTIONS
8
In the event that an Error message or Warning appears beginning• 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.
Remove the electrode applicator by pulling the cable connector only.• 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.
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Intelect® Shortwave 100
SAFETY INSTRUCTIONS
9
Do not administer shortwave diathermy to a patient who• 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.
Other equipment, including patient connected devices, may• 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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Intelect® Shortwave 100
SAFETY INSTRUCTIONS
10
If the unit is not• safe for operation, then it must be repaired
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.
The Electrode-Skin Distance (ESD) must be small for• 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 (2-
• ethylhexyl) 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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Intelect® Shortwave 100
SAFETY INSTRUCTIONS
11
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.
In case of damage from transport that could endanger personal• 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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Intelect® Shortwave 100
SAFETY INSTRUCTIONS
12
PERSONAL SAFETY
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.
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.
the patient to be treated (and the personnel) have removed
• 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.•
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Intelect® Shortwave 100
SAFETY INSTRUCTIONS
13
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).
PERSONAL SAFETY CONTINUED
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Intelect® Shortwave 100
SAFETY INSTRUCTIONS
14
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.
PROTECTION OF THE UNIT
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 non-
earthed 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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Intelect® Shortwave 100
SAFETY INSTRUCTIONS
15
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.
Never clean the unit with abrasives, disinfectants, or solvents
• 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.
PROTECTION OF THE UNIT CONTINUED
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ABOUT SHORTWAVE DIATHERMY Intelect® Shortwave 100
16
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.
Shortwave diathermy equipment normally uses the band centered
on 27.12 MHz. This corresponds to a wavelength, in a vacuum, of
approximately 11 meters.
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.
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 sec 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.
As the power levels are lower than with conventional shortwave
diathermy equipment, some of the potential dangers associated
with the modality no longer apply.
OVERVIEW
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