Intelect RPW system User Manual Rev H

TABLE OF CONTENTS

Intelect® RPW

FOREWORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Operator Qualifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

SETUP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Unpacking the Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Requirements for Installation . . . . . . . . . . . . . . . . . . . . . . . . 23 Requirements for the Installation Location . . . . . . . . . . . . 23

SAFETY INSTRUCTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Precautionary Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Dangers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Personal Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Protection of the Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

NOMENCLATURE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Rear View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Software Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

ABOUT RADIAL PRESSURE WAVE THERAPY . . . . . . . . . . . . . 16 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Pulsed Radial Pressure Wave - Introduction . . . . . . . . . . . . 17

SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Unit Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Operating Data and Ratings . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Radial Pressure Wave Specifications . . . . . . . . . . . . . . . . . . . 30 Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 Transport and Storage Conditions . . . . . . . . . . . . . . . . . . . . 30 Safety... 30 Applicator Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 R-SW Handpiece Technical Data . . . . . . . . . . . . . . . . . . . . . . 31 Description of Device Markings . . . . . . . . . . . . . . . . . . . . . . 32

INDICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 CONTRAINDICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 ADDITIONAL PRECAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Possible Side Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

OPERATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Description of Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 i

TABLE OF CONTENTS

Intelect® RPW

Installing the Applicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Replacing and Installing the Transmitter . . . . . . . . . . . . . . 34 Preparing the Unit for Therapy . . . . . . . . . . . . . . . . . . . . . . . 37 Preparing the Patient for Therapy . . . . . . . . . . . . . . . . . . . . 38 Basic Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Starting Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Home Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Edit Treatment Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Select Transmitter Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Quick Link Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Starting Therapy from the Home Screen . . . . . . . . . . . . . . 43 Using the Ramp Button... 44 Using the Ramp Button to Stop the Ramping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 Stopping, Pausing, and Completing Therapy . . . . . . . . . . 46 Stopping Therapy Using the STOP Button . . . . . . . . . . . . . 46 Pausing Therapy Using the Pause Button . . . . . . . . . . . . . . 46 Pausing Therapy Using the Trigger Button... 47 Completing the Therapy Session . . . . . . . . . . . . . . . . . . . . . . 47 Using Clinical Protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 Retrieving, Deleting, and Saving User Protocols . . . . . . . 50 Retrieving User Protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 Deleting User Protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 Saving New User Protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 Editing Existing User Protocols . . . . . . . . . . . . . . . . . . . . . . . . 52

Using Clinical Resources - Educational Libraries . . . . . . . 53 Anatomical Graphics Library . . . . . . . . . . . . . . . . . . . . . . . . . . 53 Handpiece Placement Library . . . . . . . . . . . . . . . . . . . . . . . . 54 Viewing Rationale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 Viewing Contraindications... 56 Using Clinical Resources - Patient Card . . . . . . . . . . . . . . . . 57 Viewing and Retrieving Treatments from the Patient Card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 Editing the Pain Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 Saving Treatments to the Patient Card . . . . . . . . . . . . . . . . 61 Erasing Patient Card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 Using Clinical Resources - Unit Settings . . . . . . . . . . . . . . . 63 Adding and Changing the Clinic Name . . . . . . . . . . . . . . . . 63 Increasing and Decreasing the Unit Volume . . . . . . . . . . . 63 Setting the Date and Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 Resetting Unit Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 Resetting Default Protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 Changing Languages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 Editing the Default Transmitters for Channels . . . . . . . . . 66 Resetting the Pulse Counter . . . . . . . . . . . . . . . . . . . . . . . . . . 67 Treatment Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 Positioning the Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71 Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71 Error Codes and Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . 71 ii

TABLE OF CONTENTS

Intelect® RPW

MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73 Maintaining the Intelect RPW . . . . . . . . . . . . . . . . . . . . . . . . 73 Routine Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73 Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73 Removing and Replacing the Water Bottle . . . . . . . . . . . . 75 Replacing the Projectile and Guide Tube . . . . . . . . . . . . . . 76 Safety Inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81 Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82 Warranty Repair/Out of Warranty Repair . . . . . . . . . . . . . . 82 ACCESSORIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83 Standard Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83 Optional Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83 WARRANTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84 APPENDIX A - EMC TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85 Table 1: Guidance and Manufacturer’s Declaration– Electromagnetic Emissions . . . . . . . . . . . . . . . . . . . 85 Table 2: Guidance and Manufacturer’s Declaration– Electromagnetic Immunity . . . . . . . . . . . . . . . . . . . 86 Table 3: Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Intelect RPW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88

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FOREWORD

Intelect® RPW

This manual has been written for the owners and operators of the Intelect® RPW 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 RPW system. Specifications put forth in this manual were in effect at the time of publication. However, owing to DJO, LLC's policy of continual improvement, changes to these specifications may be made at any time without obligation on the part of DJO, LLC. 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 radial pressure wave treatment.

Operator Qualifications The Intelect RPW is intended exclusively for use by medical specialists and is only allowed to be used by qualified and instructed medical persons in a clinical environment. These specialists are expected to have practical knowledge of medical procedures and applications as well as of the technology, and should be experienced in treating the indications listed on page 18. Specialists must have the basic physical and cognitive prerequisites such as vision, hearing, and literacy. Also, the basic functions of the upper extremities is expected. The Intelect RPW is designed for a demographic target group between 18 and 65 years of age.

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FOREWORD

Intelect® RPW

Product Description The Intelect RPW is intended for the use in predominately non-sterile medical sites. The Intelect RPW allows for the treatment of indications with radial, pneumatically generated, low energy acoustic waves (shock waves) or pressure pulses. The Intelect RPW is a compressed air operated ballistic shock wave generator featuring high-precision ballistic components in its applicator for shock wave generation. The motion and weight of the projectile accelerated by compressed air produce kinetic energy that is converted into sound energy when the projectile strikes an unmoved surface (shock transmitter). This acoustic pulse is transmitted to the target tissue directly. These waves are physically classified as radial pressure waves. The applied pressure pulse propagates radially within the tissue and has a therapeutic effect on areas of the tissue.

NOTE: Medical devices operating on the basis of the above principle are generally referred to as extracorporeal shock wave systems in modern medical literature. Stay current with the latest clinical developments in the field of radial pressure wave treatment. Observe all applicable precautionary measures for treatment. Keep informed on appropriate indications and contraindications for the use of radial pressure wave treatment. This equipment is to be used by, and sold to, a trained clinician only under the prescription and supervision of a licensed practitioner.

© 2017 DJO, LLC. All rights reserved. Any use of editorial, pictorial, or layout composition of this publication without express written consent from DJO, LLC is strictly prohibited. This publication was written, illustrated, and prepared for distribution by DJO, LLC. Certain portions of this manual have been reproduced with the consent of STORZ MEDICAL.

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FOREWORD

Intelect® RPW

D-20mm

D-35mm

Caution D-20mm:

Avoid using the D-20mm transmitter with pressures levels exceeding 3 Bars on screen when not applying on a non-impact surface (body). Handset is at risk for damage.

Caution D-35mm:

Avoid pressure over 3 Bars on screen at all times with D-35mm Transmitter. Handset is at risk for damage.

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FOREWORD

Intelect® RPW

GENERAL INFORMATION The Intelect RPW 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. For more information about the standards to which the Intelect RPW complies, see page 30. 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, it is essential that anyone operating the radial pressure wave 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 manual. The following features are available on the Intelect RPW 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.

Quick Link Indications The Intelect RPW 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. 4

FOREWORD

Intelect® RPW

GENERAL INFORMATION (CONTINUED) 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.

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.

Intensity Ramping Ramping the intensity via the Ramp button on the Home and Edit Treatment screens allows the unit to gradually increase the intensity from 1.4 bar to the set intensity. This feature is useful in treating conditions in which a build up of intensity is preferred over giving the patient the full intensity from the beginning of the treatment. Some patients may be initially uncomfortable with the idea of RPW. However, ramping the intensity serves to acclimate the patient to the pressure of the output. Specifically, if the ramp feature is turned on, the intensity increases to the full preset number of bars after one-third of the pulses have been given. For more information on the ramping feature available on the Intelect RPW unit, see pages 44-45.

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SAFETY INSTRUCTIONS

Intelect® RPW

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

CAUTION

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.

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

DANGER

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

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

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SAFETY INSTRUCTIONS

Intelect® RPW

CAUTION

CAUTION • The unit should be routinely checked before each use to determine

• Read, understand, and practice the precautionary operating

that all controls function normally (e.g., the STOP button ends treatment, the START button causes the treatment to begin, the trigger button on the handpiece causes the transmitter to pulse, etc.), especially that up and down arrow buttons (see page 27) adjust the number of pulses the transmitter emits. • 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 0 °C and 60 °C (32 °F and 140 °F) to prevent damage to the unit or its components. • Handle radial pressure wave treatment accessories with care. Inappropriate handling of the accessories may adversely affect their characteristics. • Inspect cables, associated connectors, and accessories before each use. • Do not use accessories other than those supplied with the unit, or recommended by DJO. The safety of other products has not been established, and their use could result in injury to the patient and degrade minimum safety.

instructions. Know the limitations and hazards associated with using any radial pressure wave treatment device. Observe the precautionary and operational decals placed on the unit. • Before use of the Intelect RPW, make sure you have read and understood all information provided in this manual. Familiarity with the information included in this manual is an essential requirement to ensure efficient and optimal use of the system, to avoid dangers to persons and to the equipment, and to obtain good treatment results. • Knowledge of the content of this manual is an essential prerequisite for operating the Intelect RPW. • Disregarding any information in this manual is considered to be abnormal usage of the unit. • DO NOT operate the Intelect RPW 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.

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SAFETY INSTRUCTIONS

Intelect® RPW

CAUTION

CAUTION

• Disconnect the power supply cord before removing covers on

• To determine the distance of separation for all equipment operating

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. • This unit 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.

near the Intelect RPW, consult the EMC tables applicable to the other equipment. • This equipment is to be used by, and sold to, a trained clinician only under the prescription and supervision of a licensed practitioner. • Only users trained in the use of radial pressure wave therapy should operate the unit and its applicators. • The Power On/Off button is considered a "soft" switch and does not isolate the unit from mains power when the unit is turned off. Therefore, you must disconnect the male end of the power supply cord from the electrical outlet (mains power supply) in order to isolate it. • The Intelect RPW is not intended for the treatment of kidney stones. • Depress the tabs of the caster locks to prevent the front wheels from moving during treatment and storage.

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SAFETY INSTRUCTIONS

Intelect® RPW

WARNING

WARNING

• Improper installation, operation, or maintenance of the

• This equipment is not designed to prevent the ingress of water

radial pressure wave system may result in malfunctions of this unit or other devices. • User must not make modification to the equipment using non-DJO, LLC parts. • In case of display failure or other obvious defects, switch the unit off immediately by means of the power on/off button, disconnect the power cord from the power outlet, and notify a certified service technician. • 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. • Position the unit to ensure safe and easy accessibility to power cord. • Keep all line cords away from the unit cables. Do not store or coil line cords where they can come close to the cables on an operating radial pressure wave unit. Position the power cord in such a way that it does not present a tripping hazard. • Do not block the air vents.

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 RPW 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. DJO 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. • Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous exposure to radial pressure wave 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. • Do not leave patient unattended during radial pressure wave therapy.

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SAFETY INSTRUCTIONS

Intelect® RPW

WARNING

WARNING • The surface of the transmitter can become hot if the unit is used

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

outside of the parameters listed on page 29. Therefore, the operator must monitor the temperature of the transmitter during the treatment session. • Do not apply more than 300 pulses to the same spot. • For continued protection against fire hazard, replace fuses only with ones of the correct type and rating.

NOT remove by pulling the cable. • To remove the cable from the applicator, make certain the power is off. Hold the applicator while removing the cable to prevent the applicator from dropping to the floor. • Observe the patient at all times during therapy. • Operating the unit at pressures higher than 3 bar without an impact surface can result in damage to the handset. • 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 DJO for service. Errors and Warnings in these categories indicate an internal problem with the unit that must be tested by DJO or a Field Service Technician certified by DJO 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. • Empty the water bottle at least once weekly or if it is half full. For instructions on removing and replacing the water bottle, see page 75. • Treatment should never be given in the area of metal implants. • Place the unit on a flat surface during treatment and storage to prevent tipping and rolling. • The surface of the transmitter can become hot. Extended skin contact can cause minor burns. Interrupt therapy after a maximum of 6000 pulses to allow the transmitter to cool.

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SAFETY INSTRUCTIONS

Intelect® RPW

DANGER

DANGER

• The function of certain implanted devices (e.g., pacemakers)

from the socket before cleaning or disinfecting the unit.

may be adversely affected during treatment with radial pressure wave. In case of doubt, the advice of a licensed practitioner in charge of the patient should be sought. • Other equipment, including patient connected devices, may be adversely affected when in close proximity to radial pressure wave equipment. • Patients should not be treated with radial pressure wave when they have a sensitivity to acoustic pressure. • Patients should not be treated with radial pressure wave 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 in pulsed modes. • Remove hearing aids prior to treatment. • Before each use, check the condition of the housing and the insulation of the applicator and power supply cable. Also make sure that the cables have been routed correctly. • 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

• Under no circumstances may liquid penetrate the openings

on the unit (e.g. the connecting sockets of the cables). Therefore, do not use cleaning or disinfectant sprays. • The unit 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. • The unit's components are under pressure and subject to high voltage. Do not perform unauthorized repairs under any circumstances. • Shock waves must not be applied to target areas located above air filled tissue (lungs), nor to any regions near large nerves, vessels, the spinal column or head. • The operator should not use radial pressure wave over the heart in order to prevent theoretical cardiac signal interference. • 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. • Explosion hazard if the Intelect RPW is used in the presence of flammable anesthetics mixture with air, oxygen, or nitrous oxide.

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SAFETY INSTRUCTIONS

Intelect® RPW

DANGER

DANGER

• The Intelect RPW unit may contain Di (2-ethylhexyl)

• The effects of BPA and DEHP are not known in the

phthalate (DEHP) which is the plasticizer for most PVC medical devices. Everyone is exposed to small levels of DEHP in everyday life. However, some 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.

concentrations present in the unit and its applicators.

• 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.

• The Intelect RPW 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.

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SAFETY INSTRUCTIONS

Intelect® RPW

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 handset or false parameters such as the duration of treatment, power output or operating mode.

Before using the unit, speak with the patient to verify: • The patient is in a comfortable position during the entire treatment. • That the patient is comfortable before and during treatment. • That the patient understands what to expect during and after treatment. Before using the unit, determine the maximum nominal output power of the respective accessory in order to avoid overheating the tissue.

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 7-12, "Contraindications" on pages 19-20, and "Additional Precautions" on page 21.

At regular intervals during the treatment, verify: • That the unit is functioning properly • 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.

Before operating the unit each time, verify that: • The unit has been correctly connected to the Mains Power Supply. • The handset connection cable is connected properly and is not cross-routed (which may cause capacitive short circuits). • Only accessories approved by the manufacturer are connected. • The handset is positioned according to the doctor’s instructions (to be checked by the doctor or physiotherapist if applied by assisting personnel).

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 moistureresistant 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. 13

SAFETY INSTRUCTIONS

Intelect® RPW

PROTECTION OF THE UNIT

WARNING Improper installation, operation or maintenance of the radial pressure wave unit may result in malfunctions of this unit or other devices.

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.

WARNING 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® RPW

PROTECTION OF THE UNIT (CONTINUED) 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 handset connection cable and the transmitters are undamaged and have been connected correctly to 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.

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ABOUT RADIAL PRESSURE WAVE THERAPY

Intelect® RPW

OVERVIEW • Shock waves stimulate nociceptors which, in turn, release

Radial shock waves (R-SW) are introduced into the body by means of a freely moved applicator and cover the entire pain region. Radial shock waves are often referred to as radial pressure waves, which is the correct definition in physical terms.

a high amount of neural pulses. As described by the Gate Control Theory, transmission of these pulses to the central nervous system is inhibited. • Owing to the mode of action of shock waves, the chemical environment of the cells is changed by free radicals which produce pain inhibiting substances. • Based on the hypothesis towards associative pain memory (Wess), afferent pain signals are transmitted through the central nervous system by multiple synaptic junctions which eventually cause efferent fibers to control muscle tone. The reflex mechanism works just like a regulatory circuit. During shock wave therapy, strong pain signals are conducted electrically, stimulating chemical processes at the synaptic contact sites. The complex spatial and time-related stimulus pattern is stored at the synapses as a memory engram in the form of longterm modifications. The pathological association between pain and muscle tone and vascular tone is broken as a result of shock wave therapy and the strong stimuli it produces, thus enabling natural movement patterns to be remembered and recalled. In this manner, a non-pathological condition of the muscle tone can be restored.

The transmitter is a compressed air operated, ballistic shock wave generator. A projectile is accelerated by compressed air. The kinetic energy stored in the motion and weight of the projectile is converted into acoustic energy in the form of long-wave shock pulses when the projectile strikes a shock transmitter. Radial shock waves propagate divergently after application and lose energy as the penetration depth increases. They are characterized by long wave lengths and cannot be focused on deep target areas. Penetration depths are between 1 and 3 cm. Their maximum energy flux density is at the exit point from the shock transmitter. There are different working hypotheses for the mode of action of shock waves which can also be applied to radial shock waves: • Shock waves destroy cell membranes. Consequently, the nociceptors are no longer able to produce generator potential and can thus no longer send out any pain signals.

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