User Manual

Operation & Installation

Instructions for:
Intelect Radial Pressure Wave (RPW)
REF 2082 (100 V)
REF 2073 (120 V)
REF 2074 (230V)
TABLE OF CONTENTS
FOREWORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operator Qualifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SAFETY INSTRUCTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Precautionary Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Dangers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Personal Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Protection of the Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
ABOUT RADIAL PRESSURE WAVE THERAPY . . . . . . . . . . . . . 16
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Pulsed Radial Pressure Wave - Introduction . . . . . . . . . . . . 17
INDICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CONTRAINDICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
ADDITIONAL PRECAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Possible Side Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Intelect® RPW
1 SETUP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
1 Unpacking the Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
2 Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
4 Requirements for Installation . . . . . . . . . . . . . . . . . . . . . . . . 23
Requirements for the Installation Location . . . . . . . . . . . . 23
NOMENCLATURE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Rear View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Software Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Unit Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Operating Data and Ratings . . . . . . . . . . . . . . . . . . . . . . . . . . 29
18
Radial Pressure Wave Specifications . . . . . . . . . . . . . . . . . . . 30
18 Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
18 Transport and Storage Conditions . . . . . . . . . . . . . . . . . . . . 30
18 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Applicator Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
R-SW Handpiece Technical Data . . . . . . . . . . . . . . . . . . . . . . 31
Description of Device Markings . . . . . . . . . . . . . . . . . . . . . . 32
OPERATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Description of Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
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TABLE OF CONTENTS
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
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Intelect® RPW
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
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

iii
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.

1
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.
2
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.

3
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.

5
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:

CAUTION
Text with a “CAUTION” indicator will explain possible safety
infractions that could have the potential to cause minor to
moderate injury or damage to equipment.
WARNING
Text with a “WARNING” indicator will explain possible safety
infractions that will potentially cause serious injury and
equipment damage.
Explosion Hazard
Text with an “Explosion Hazard” indicator will explain
possible safety infractions if this equipment is used in the
presence of flammable anesthetics.
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.
Refer to Instruction Manual/Booklet

DANGER NOTE: Throughout this manual, “NOTE” may be found. These

Notes are helpful information to aid in the particular area
Text with a “DANGER” indicator will explain possible safety or function being described.
infractions that are imminently hazardous situations that would
result in death or serious injury.

6
SAFETY INSTRUCTIONS
CAUTION
• Read, understand, and practice the precautionary operating
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.
7
Intelect® RPW
CAUTION
• The unit should be routinely checked before each use to determine
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.
SAFETY INSTRUCTIONS
CAUTION
• 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.
• 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.
8
Intelect® RPW
CAUTION
• To determine the distance of separation for all equipment operating
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.
SAFETY INSTRUCTIONS
WARNING
• Improper installation, operation, or maintenance of the
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.
9
Intelect® RPW
WARNING
• 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 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.
SAFETY INSTRUCTIONS Intelect® RPW

WARNING WARNING
• Remove the applicator by pulling the cable connector only. DO • The surface of the transmitter can become hot if the unit is used
NOT remove by pulling the cable. outside of the parameters listed on page 29. Therefore, the operator
• To remove the cable from the applicator, make certain the power must monitor the temperature of the transmitter during the
is off. Hold the applicator while removing the cable to prevent the treatment session.
applicator from dropping to the floor. • Do not apply more than 300 pulses to the same spot.
• Observe the patient at all times during therapy. • For continued protection against fire hazard, replace fuses only
• Operating the unit at pressures higher than 3 bar without an with ones of the correct type and rating.
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.

10
SAFETY INSTRUCTIONS
DANGER
• The function of certain implanted devices (e.g., pacemakers)
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
11
Intelect® RPW
DANGER
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 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.
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 concentrations present in the unit and its applicators.
medical devices. Everyone is exposed to small levels of • In case of damage from transport that could endanger
DEHP in everyday life. However, some individuals can be personal safety, the unit must not be connected to the
exposed to high levels of DEHP through certain medical mains power supply before inspection is complete.
procedures. DEHP can leach out of plastic medical devices
into solutions that come into contact with the plastic. • Adhere to rules, regulations, and ordinances that may vary
The amount of DEHP that will leach out depends on from location to location concerning the appropriate use
the temperature, the lipid content of the liquid, and the of high powered radio frequency fields.
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 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.

12
SAFETY INSTRUCTIONS
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 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.
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).
13
Intelect® RPW
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.
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.
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.
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.

14
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.

15
ABOUT RADIAL PRESSURE WAVE THERAPY
OVERVIEW
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.
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.
16
Intelect® RPW
• Shock waves stimulate nociceptors which, in turn, release
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 long-
term 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.
ABOUT RADIAL PRESSURE WAVE THERAPY Intelect® RPW

OVERVIEW (CONTINUED)
Treatment results have demonstrated that shock wave therapy provides improved blood circulation in the treated pain regions and that
a long term stimulation of metabolism is achieved in areas which, by nature, are poorly supplied with blood. Since repeated treatment
sessions have shown to increase the beneficial effects of shock wave therapy, there is every reason to assume that shock waves also
produce secondary effects as described in the hypothesis towards associative pain memory, for instance.

Pulsed Radial Pressure Wave - Introduction

Pulsed radial pressure wave equipment delivers the energy in pulses or bursts of radial pressure wave energy. The pulses are typically 6
to 12ms in duration (pulse width) and are repeated with a frequency of 0.5 to 21 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 radial pressure wave treatment appears to be effective for many conditions especially in the early
stages of recovery.

17
INDICATIONS Intelect® RPW

GENERAL
Before a treatment with Radial Pressure Wave, a correct examination
and diagnosis should be performed. Please stay current with the latest
developments and medical publications on Radial Pressure Wave therapy
for details on contraindications and side effects not known at the time of
manufacturing.
INTENDED USE
The device is intended to be used as a therapeutic modality by clinicians
needing to provide patients with a powerful and a proven method of
treating indications as pain, Myofascial trigger points, Disorders of tendon
insertions, activation of muscle and connective tissue.
INDICATIONS FOR USE
Radial pressure wave therapy is indicated for the following:
Myofascial Trigger Points (MTrP)
Localizing and Deactivating Trigger Points
Triggers are localized at the low energy level (approximately 2 bar) by
passing the transmitter over the muscle region being treated (increased
sensitivity to pain) and then deactivated using a higher energy level
(approximately 3 bar).
Activation of Muscle and Connective Tissue
Increasing Circulation
Promotes blood flow through the tissue and boosting metabolism.
Pulse Vibration Massage
Soothing relief from muscle strain and stress.
Disorder of Tendon Insertions
Plantar Fasciitis, Heel Pain, or Heel Spur
Plantar Fasciitis is an inflammatory condition of the foot caused by
excessive wear to the plantar facia that supports the arch
Tendinosis Calcarea/Supraspinatus-Tendon
Shoulder calcifications and chronic shoulder pain
Radial and Ulnar Humeral Epicondylitis
Tennis elbow, inflammation of tendon attachments on cubital or radial part
of elbow joint (humeral)
Achillodynia
Pain due to inflammation of the Achilles tendon or the bursa associated
with it.
Retropatellar Pain Syndrome
Pain in the front of, behind, and around the kneecap.
Tibial Edge Syndrome
Pain located along or just behind the medial edge of the tibia
Proximal Iliotibial Band Friction Syndrome/Trochanteric Insertion
Tendonitis
Pain or aching on the outer side of the knee or hip

18
CONTRAINDICATIONS
GENERAL
Before a treatment with Radial Pressure Wave, a correct examination
and diagnosis should be performed. Stay current with the latest
developments and medical publications on Radial Pressure Wave
therapy for details on contraindications and side effects not
known at the time of manufacturing. The Intelect RPW unit is
contraindicated for the following:
• Do not use Radial Pressure Wave treatment on any body part
during pregnancy.
• Over the pregnant or potentially pregnant uterus. Therefore,
radial pressure wave treatment should not be applied over
the uterus unless specific assurance can be attained from the
patient that she is not pregnant.
• Haemophilia, or other coagulation disorders.
• Anticoagulant pharmaceuticals, especially Marcumar.
• Acute inflammations. Do not use over swollen, inflamed,
infected tissue, skin eruptions or on other acute tissue lesions.
• Polyneuropathy area. A Diabetes patient often obtains
disturbed sensory and nervous function in the
polyneuropathic area.
• Cortisone therapy: Wait minimum 6 weeks after local
cortisone injection before treatment with radial pressure
waves.
19
Intelect® RPW
• Patients with hemorrhages or risk of hemorrhage.
• Patients with malignant tumors and undiagnosed tumors.
• Swellings that still feel warm.
• Implants, areas where implants have been removed,
damaged implants, and metal inclusions.
• Over superficial endoprosthesis or metal implants.
• Severe arterial obstructions (stage III and IV).
• Gynecological disorders involving acute inflammation.
• Deep vein thrombosis, phlebitis, varices.
• Arterial disease, circulatory insufficiency.
• Over eyes.
• Over reproductive organs.
• Over cardiac pacemakers and defibrillators, cochlear implants,
bone growth stimulators, deep brain stimulators, spinal cord
stimulators, and other nerve stimulators.
• Over open lamina (after laminectomy; spina bifida).
• Directly over the carotid sinuses, ceruical stellate ganglion, or
Vagus nerve located in the anterior neck triangle.
• Direct application over cancerous tumors or lesions due to its
potential to increase blood flow to the area of malignancy.
• Neoplastic tissues or space occupying lesions.
CONTRAINDICATIONS Intelect® RPW

GENERAL (CONTINUED)
• Occlusive vascular disease, such as arteriosclerosis obliterans
and thromboangitis obliterans, in which organic occlusion
and ischemia are evident.
• In the presence of systemic or local infection (sepsis,
Osteomyelitis, tuberculosis) or if the patient has an elevated
temperature.
• 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.

20
ADDITIONAL PRECAUTIONS Intelect® RPW

GENERAL
When administering radial pressure wave treatment, keep in mind Possible Side Effects
the following: Side effects could occur after a treatment with Radial Pressure wave
• Radial pressure wave treatment should be applied with therapy. The majority will appear after 1-2 days.
caution over bone where minimal (bony prominence) or no
Do not repeat a treatment until the previous side effects have
(Stage IV wounds) soft tissue is present.
diminished. Common side effects include:
• Hearing aids should be removed.
• The function of other patient connected equipment may • Reddening
be adversely affected by the operation of the pulsed radial • Swelling
pressure wave equipment. Maintain maximum distance • Pain
between units in order to reduce any tendency to interaction. • Hematoma
Refer to the EMC tables beginning on page 85 for more • Petechiae, red spots
information.
• Skin lesions after previous cortisone therapy
• Any bleeding tendency is increased by heating because
of the increase in blood flow and vascularity of the heated These side effects generally abate after 5 to 10 days.
tissues. Care, therefore, should be used in treating patients
with therapeutic radial pressure wave treatment who have
bleeding disorders.
• Frequent monitoring of intensity level and skin response
should occur during all treatments.
• Always apply the transmitter on the skin with small circular
movements.
• Never use Radial Pressure Wave therapy on the head.
• Do not treat direct in an area with a metal implant.
• Patients with active autoimmune diseases may not respond
positively with the treatment.
21
SETUP Intelect® RPW

UNPACKING THE UNIT

DANGER
The unit is generally delivered with the packaging material supplied
by the manufacturer. Since the unit weighs approximately 32.66 kg
(72 lbs), it must be unpacked by at least 2 persons.
In case of damage from transport that could endanger personal
Proceed as follows: safety, the unit must not be connected to the Mains Power Supply
• Position the transport packaging so that the arrows are before inspection is complete.
pointing upward.
• Remove the safety bands from the transport packaging. 3. Verify that the packaging contains the following
• Remove the transport packaging upward. • Intelect RPW unit
• Remove the remaining foam material. • Intelect RPW CD User Manual
• Using at least 2 people, lift the unit from the lower packaging • Intelect RPW Quick Start Guide
element. • Conductor™ Transmission Gel-250 ml (8.5 oz) bottle
Standard Accessory Kit that Includes the following:
Inspection
Immediately upon unpacking the unit, perform the following steps: – R-SW Handpiece Applicator
1. Verify the delivery documents to make sure that the delivery is – Projectile
complete. – R15 - 15 mm ESWT Transmitter
2. Check the external components and accessories for possible – D20-S D-ACTOR® 20 mm Transmitter
damage due to transport. – Sealing Set
– Guide Tube
– Cleaning Brush
• Power cord
4. Retain the original packaging. It may prove useful for any
equipment transport.
22
SETUP Intelect® RPW

REQUIREMENTS FOR INSTALLATION

Before the unit can be installed and put into operation, certain There is no need to plug the power cord into an isolated circuit for
requirements must be fulfilled in the building where the unit is to the proper function of this unit.
be operated.

WARNING
• 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.

Requirements of the Installation Location

DANGER
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
Instructions on pages 6-12 and the following information.

Keep in mind the room and the installation location must be large
enough so that the unit can be operated from the front even if the
handpiece is positioned inconveniently.

23
NOMENCLATURE Intelect® RPW

FRONT VIEW
1. User Interface (see page 26)
1
2. Handpiece
3. Handpiece connection cable
4. Locking caster
5. Non locking castors
9
6. IEC Connector for Power Cord
7. Storage Bin
2 8. Grab Bar
8
9. Swivel Console

3
7

4
6

5
24
NOMENCLATURE Intelect® RPW

REAR VIEW

1. Expansion Port (for Service Use only)

2. Transmitter Storage Compartment
1 2 3. Handpiece, Cable, and Gel Tray
3
4. Output Sockets
5. Cable Storage Hooks

25
NOMENCLATURE Intelect® RPW

USER INTERFACE
2
1 1. Power On/Off Button
2. Liquid Crystal Display (LCD) and Touch Screen
3. Clinical Resources Button
4. START Button
3 5. PAUSE Button
6. Multimedia Card (MMC) Port
7. Patient Data Card Port
8. STOP Button
9. Power LED

4
5
6
8

7
26
NOMENCLATURE Intelect® RPW

SOFTWARE SYMBOLS
Display the Edit Treatment Screen Cancel and Return to Previous Screen

Up Arrow (Increase) Change Text to Upper Case

Change Text to Lower Case

Down Arrow (Decrease)

Radial pressure wave energy is being emitted

Touch and Slide Left to Increase

Massage therapy is being emitted
Touch and Slide Right to Decrease

Pause
Back (Return to Previous Screen)

Transmitter Type
Display the Home Screen

Move the cursor to the left one space Number of Pulses

Pulse Frequency
Move the cursor to the right one space

Accept/Select (Parameters)
27
NOMENCLATURE Intelect® RPW

ACCESSORIES
Handpiece 1. 20 mm Insert

WARNING (Transmitter)
2. Front Cap
Keep all accessories and their cords separated during treatment by 3. Rear Cap
using the hook located on the side of the unit. Accessories or their
cords in contact with each other during treatment could result in 4. Shaft
improper stimulation, skin burns, or damage to the cord or accessory.
5. Handle
6. Trigger Button
4
7. Vibration Absorber
Cushion
8. Cable
1

2 3 5 6 7

28
SPECIFICATIONS Intelect® RPW

UNIT SPECIFICATIONS
Ambient temperature . . . . . . . . . . . . . . +10 °C to 35 °C (50 °F to 95 °F)
Relative Humidity . . . . . . . . . . . . . . . . 5% to 90% NC (non-condensing)
Air Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 500 hPa to 1060 hPa
Power Consumption . . . . . . . . . . . . . . . . . . . . . . . . . 840 VA (Model 2082)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 780 VA (Model 2073)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 610 VA (Model 2074)
Input . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100 V ~, 50/60 Hz (Model 2082)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120 V ~, 60 Hz (Model 2073)
HEIGHT
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 230 V ~, 50 Hz (Model 2074)
Pressure Vessel Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.3 L
DEPTH
Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Single or Continuous
Compressed Air Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.4 - 5 bar
Power Increment Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.2 bar
Power Indication . . . . . . . . . . . . . . . . . . . maximum and average power
TH Pulse Amplitude . . approx. 2 mm at 3 bar, idling (without coupling)
WID
0086 Pulse Width . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . approx. 6 - 12 ms
Pulse Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.5 - 21 Hz
Fuses . . . . . . . . . Two 6.3 A Time Lag 5 x 20 mm (not user serviceable)
Electrical Class . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CLASS I
Electrical Type (Degree of Protection) . . . . . . . . . . . . . . . . . . . TYPE B
Operating Data and Ratings
Width . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 420 mm (16.5") Protection against water ingress. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IPX0
Depth . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 410 mm (16.14") Regulatory Risk Class . . . . . . . . . . . . . IIa according to MDD 93/42/EEC
Height . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1143 mm (45")
Standard Weight (with one handset) . . . . . . . . . . . . . . 32.66 kg (72 lbs)
29
SPECIFICATIONS Intelect® RPW

UNIT SPECIFICATIONS (CONTINUED)

Software
The software is developed and provided by DJO, LLC.
To view the version of the software, press the Unit Settings button
on the Clinical Resources screen. The version number of the
software appears at the top of the screen.

Transport and Storage Conditions

Ambient temperature . . . . . . . . . . . . . . . 0 °C to 60 °C (32 °F to 140 °F)
Relative Humidity . . . . . . . . . . . . . . . . . 5% to 90% NC (non-condensing)
Air Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 500 hPa to 1060 hPa

Safety
The Intelect RPW has been designed to meet the requirements of
IEC/EN 60601-1,
CAN/CSA STD C22.2 No. 601.1

30
SPECIFICATIONS Intelect® RPW

APPLICATOR SPECIFICATIONS
Pay special attention to the list of contraindications. Refer to
"Safety Instructions" on pages 7-12, "Contraindications" on pages
19-20, "Additional Precautions" on page 21, and "Personal Safety"
on page 13.

R-SW Handpiece Technical Data

Compressed Air Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.4 - 5 bar
Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.5 - 21 Hz

Ambient Air Temperature

See Unit Specifications, page 29

To get technical data on specific transmitters, press the Transmitter

Information button on the Select Transmitter screen (page 41).

31
SPECIFICATIONS Intelect® RPW

DESCRIPTION OF DEVICE MARKINGS

The markings on the Intelect RPW system are your assurance of its conformity to the highest applicable standards of medical equipment safety and
electromagnetic compatibility. One or more of the following markings may appear on the device:
Meets Directive 93 /42 /EEC

0086 Unit produces radial pressure wave (shockwave) energy.

Refer to Instruction Manual/Booklet

Contents under pressure.

Type B Equipment

Council Directive 2002/96/EC concerning Waste Electrical

and Electronic Equipment (WEEE). Indicates a requirement
not to dispose of WEEE as municipal waste. Contact your local The unit and its accessories are latex-free.
distributor for information regarding disposal of the unit and
accessories.

Adjustments or replacement of components may result in Safety agency symbol indicating device meets general safety
the equipment failing to meet the requirements for requirements for medical electrical equipment
interference suppression.

This equipment is to be used by, and sold to, a trained
clinician only under the prescription and supervision
of a licensed practitioner (U.S. only).
32
Ambient temperature . . .+10 °C to 35 °C (50 °F to 95 °F)
Relative Humidity . . .5% to 90% NC (non-condensing)
Air Pressure . . .500 hPa to 1060 hPa
SPECIFICATIONS Intelect® RPW

DESCRIPTION OF DEVICE MARKINGS

This icon is located adjacent the stop button and terminates the treatment
Stop: Stops treatment

This icon is adjacent to the start button and initiates the treatment.
Starts: Starts treatment

This icon is located directly above the treatment pause button and allows access
Clinical Resources: to access the Educational Libraries to the clinical library.

This icon is located above the patient data card port and allows for software
MMC: multimedia card upgrades.

This icon is located below the multimedia card port and allows for patient
PATIENT CARD: patient data card treatment protocols to be saved on this card.

33
OPERATION Intelect® RPW

DESCRIPTION OF FUNCTIONS
Pressure waves with different features are used in modern medicine today. Pressure waves are usually generated by the collision of solid
bodies with an impact speed of a few metres per second (approx. 5 – 20 m/s), far below the sound velocity. First, a projectile is accelerated,
(e.g. with compressed air using an air gun), to a speed of several meters per second and then abruptly slowed down by hitting an impact
body. The elastically suspended impact body is brought into immediate contact with the surface of the patient above the area to be
treated, preferably using coupling gel. When the projectile strikes the impact body, part of its kinetic energy is transferred to the impact
body, which also makes a translational movement over a short distance (typically < 1 mm) at a speed of around one meter per second
(typically < 1 m/s) until the coupled tissue or the applicator decelerates the movement of the impact body.
The motion of the impact body is transferred to the tissue at the point of contact, from where it propagates divergently as a radial pressure
wave.
Pressure waves as described here emanate from the application point of the impact body and travel radially into the adjacent tissue. The
energy density of the induced pressure wave quickly drops with increasing distance from the application point (by a proportion of 1/r²), so
that the strongest effect is at the application point of the applicator.
It appears that the principle of action is so universal that a multitude of very different indications respond positively to shock wave therapy.
In order to study the mechanisms of action, the shock waves used must be precisely characterized using the parameters described in
the text. This is the only way to determine dosage/effect relationships and to obtain sound knowledge about the mechanism of action.
However, the fact that focused shock waves and unfocused pressure waves, which have clear physical differences, show similar effects,
especially in the stimulation of healing processes, suggests that both forms of energy do not exert a direct mechanical effect but rather
have an impact on the senso-motoric reflex behavior. It seems that a reorganization of pathological reflex patterns that are anchored
in memory due to the stimulating effect of shock and pressure waves cannot be ruled out. This would open up a previously unknown
potential for further therapeutic areas of application.
Intelect RPW units are therefore used for a wide range of applications in hospitals and in private practices by doctors and physiotherapists.

34
OPERATION Intelect® RPW

INSTALLING THE APPLICATOR

Replacing and Installing the Transmitter 4. Remove and replace the O
The handpiece is shipped fully assembled, but if the transmitter rings on the transmitter if
ever requires replacement, do the following: necessary.

1. Unplug the unit.

2. Unscrew the rear cap by

turning it counterclockwise
and holding the handpiece.

5. Press the transmitter and

spacers through the front
cap.
3. Unscrew the front cap
by turning it counter
clockwise and holding the
rear cap.

35
OPERATION Intelect® RPW

INSTALLING THE APPLICATORS (CONTINUED)

6. Press the front cap onto 8. Align the red dot on the
the rear cap and turn connector with the red dot
the rear cap clockwise to on the socket and press the
tighten it. connector into the socket.

CAUTION 9. Use the cable hook on the

side of the unit to store the
applicator cable.
Do not cross-thread the two caps with tightening.

7. Fit the rear cap onto the

handpiece and turn it
clockwise and holding the
handpiece. Tighten until
snug.

36
OPERATION Intelect® RPW

INSTALLING THE APPLICATORS (CONTINUED)

WARNING
.

• Do not cross cables.

• To remove the cable from the handpiece, make certain the power
is off. Hold the handpiece while removing the cable to prevent the
handpiece from dropping to the floor.
• Observe the patient at all times during therapy.

37
OPERATION Intelect® RPW

PREPARING THE UNIT FOR THERAPY

DANGER
The unit has been completely assembled in the factory and is
ready for use except for connection of the handpiece and the
power cord.
The unit and the handpiece must be positioned so that there is no
Proceed as follows in order to prepare the unit for operation: danger of personal injury. Therefore, you must read and observe the
• Make sure that the voltage rating on the serial decal safety instructions and the list of contraindications before putting
conforms to the system voltage of the building. the unit into operation.
• Install the required transmitter (insert) into the handpiece.
See page 34 for more information on installing the

WARNING
transmitter.
• Plug the handpiece cable into the socket on the back of
the unit. Attach the connecting cable in the cable hook on
the side of the unit. Make certain that the unit is electrically earthed by connecting
only to an earthed electrical service receptacle, conforming to the
• Check the condition of the housing and the insulation of applicable national and local electrical codes.
the handpiece, handpiece connection cable, and the power
supply cable. Also make sure that the cables have been
routed correctly.
• Insert the power cord plug into an earthed socket outlet.
There is no need to plug the power cord into an isolated
circuit for the proper function of this unit.
• Position the device such that it is not difficult to disconnect
the power cord plug from the outlet, in case of emergency.
• Depress the tabs of the caster locks to prevent the front
wheels from moving.

38
OPERATION Intelect® RPW

PREPARING THE PATIENT FOR THERAPY

Before applying radial pressure wave to the patient, you must first
prepare the patient’s skin. By properly preparing the patient’s skin
for therapy, you will allow more energy to reach the targeted areas
and reduce the risk of skin irritation.
To prepare the patient’s skin for therapy, do the following:
1. Thoroughly wash the skin on which you intend to administer
therapy with mild soap and water or alcohol wipe.
2. Dry the skin thoroughly.
3. Apply the coupling gel generously to the target area on the
patient.

39
OPERATION
BASIC OPERATION
1. Connect the male end of
the power supply cord to
an appropriate electrical
outlet.
2. Connect the female end of
the power supply cord into
the IEC connector on the
side of the unit.
3. Depress the tabs of the
caster locks to prevent the
front wheels from moving.
40
Intelect® RPW
4. Press the Power On/Off
button or touch the LCD.
The following occurs when
the Power On/Off button
is pressed or the LCD is
touched:
• three quick beeps
sound
• the blue LED illuminates
• the Home Screen
displays.
The Operator Interface consists of buttons with a touch screen
liquid crystal display (LCD). The operator is able to view parameter
options on the display and make selections by pressing the buttons
directly on the LCD. The LCD provides continuous information
during the treatments concerning intensity and the number of
pulses given. Parameters are adjusted using the and buttons.
The output can be stopped by the user by pressing the PAUSE or
STOP buttons located on the Operator Interface.
OPERATION Intelect® RPW

STARTING THERAPY
The Intelect RPW offers the following methods from which you can Edit Treatment Screen
begin a treatment session:
• Quick Link Indications (page 42) 1. On the Home Screen, press
• Home screen (page 43) the button. The Edit
Treatment screen displays.
• Clinical Protocols (page 48)
• User Protocols (page 50)
• Patient Card (page 57)
Home Screen
The Home screen serves as the main treatment screen. After the
treatment parameters have been selected, you may increase or 2. Increase the parameters on
decrease the output power (in bars) during therapy on the Home the Edit Treatment screen
screen by using the and buttons. by pressing the button.

3. Decrease the parameters

by pressing the button.

41
OPERATION Intelect® RPW

STARTING THERAPY (CONTINUED)

4. You may also increase and treatment. See "Select
decrease parameters by Transmitter Screen" for
pressing and sliding the more information on this
button either left or right. feature.

5. Press the Mode button 8. Press the button to

to select either Single or return to the previous
Continuous. screen.
NOTE: Pulse Frequency
9. Press the button to
parameters are
return to the Home screen.
not available
when Single
Select Transmitter Screen
mode is selected.
1. On the Edit Treatment
6. Press the Ramp button screen, press the
to turn the ramping Handpiece/Transmitter
feature on or off. For button. The Select
more information on the Transmitter screen displays.
ramping feature, see pages
44-45.

7. Press the Handpiece/

Transmitter button to
select the transmitter for

42
OPERATION Intelect® RPW

STARTING THERAPY (CONTINUED)

2. Press the transmitter to
highlight it, or press the
and buttons to
scroll through a list of the
available transmitters.
3. Press the Transmitter
Information button to
display technical details of
the transmitter.
4. Press the button to
accept the highlighted
selection and return to the
Edit Treatment screen.
5. Press the button to
return to the previous
screen.
43
6. Press the button to
return to the Home screen.
Quick Link Indications
By pressing the Quick Link Indications button on the Home screen,
you can access specific pre-programmed indications, for general
reference only, which aid in selecting the proper output and
handpiece placement for particular indicated patient syndrome
diagnoses.
1. On the Home screen, press
the Quick Link Indications
button. The Quick Link
Indications screen displays.
2. Click one of the buttons on
the Quick Link Indications
screen (depending on the
needs and symptoms of
the patient). The Home
screen displays with
the pre-set parameters
for the indication you
selected displays to begin
OPERATION
STARTING THERAPY (CONTINUED)
treatment. For example,
you may have pressed
the Low Back Pain button
which would cause the
Home screen to display the
parameters for treating that
condition.
Starting Therapy from the Home Screen
1. On the Home screen, press
the and buttons to
set the appropriate output
power (in bars) for therapy.
44
Intelect® RPW
2. Press the START button on
the User Interface to begin
treatment. When the START
button is pressed, the
icon displays.
3. Press the trigger button on
the handpiece to activate
the handpiece. The unit
begins emitting radial
pressure wave energy.
OPERATION Intelect® RPW

STARTING THERAPY (CONTINUED)

Using the Ramp Button 3. When the START button
The Ramp button turns the ramping function on and off. Ramping and the trigger button on
the intensity serves to acclimate the patient to the pressure of the the handpiece are pressed,
output instead of administering the full output all at once. When notice that the progress
pressed, the Ramp button allows the unit to gradually increase the bar gradually increases to
intensity from 1.4 bar to the set intensity. the 3.8 bar setting. The full
intensity is reached when
NOTE: The ramping feature is not available while a treatment one-third of the pulses
session is in progress. have been given to the
patient (666 pulses in this
1. For example, on the Home
example).
screen, set the intensity to
3.8 bar. If the PAUSE button or
the trigger button on
2. Press the Ramp button so the handpiece is pressed
that it reads "On." to pause the treatment
before the intensity has
fully ramped, the ramping
feature continues when
treatment resumes.

45
OPERATION Intelect® RPW

STARTING THERAPY (CONTINUED)

Using the Ramp Button to Stop the Ramping For example, if you set the
When using the ramping feature during a treatment session as intensity at 3.8 bar, and
described in the previous section, the intensity can be stopped you pressed the Ramp
by pressing the Ramp button (the Ramp button will read "Ramp button before the intensity
Off"). This feature is especially useful if the patient becomes reached 3.8 bar, the rest of
uncomfortable with the intensity, or if the intensity level is being the treatment would be set
achieved by the patient's response. at the intensity at which
you pressed the button (2.0
1. After completing steps bar in this example).
1-2 on page 44, press the
START button and the
trigger button on the
handpiece.
Notice that the progress
bar gradually increases.

2. When the Ramp button

is pressed before the
intensity is fully ramped,
the intensity level is set at
that level.

46
OPERATION
STOPPING, PAUSING, AND COMPLETING THERAPY
Stopping Therapy Using the STOP Button
To stop therapy, press the STOP button on the User Interface. When
the STOP button is pressed:
• the applicator stops emitting radial pressure wave energy.
• the message "Treatment has been stopped by user. Touch
anywhere to continue . . ."
• the unit sounds three long tones.
1. Touch the screen. The
Treatment Complete
screen displays.
If you choose to save the
current parameters to a
patient card, press the Save
to Patient Card button and
follow the instructions on
page 61, beginning with
step 2.
If you choose to save the
current parameters as a
user protocol, press the
Save Protocol button and
follow the instructions on
47
Intelect® RPW
page 51 beginning with
step 4.
If you choose to start
over with the same
treatment, press the Run
this Treatment button. You
are returned to the Home
Screen with the same
parameters displayed.
Pausing Therapy Using the Pause Button
The therapy can be interrupted at any time by pressing the PAUSE
button on the User Interface. When the PAUSE button is pressed,
the following occurs:
• the applicator stops emitting radial pressure wave energy
• the (pause) symbol displays and blinks
To resume therapy, press the PAUSE or START buttons on the User
Interface.
OPERATION Intelect® RPW

STOPPING, PAUSING, AND COMPLETING THERAPY (CONTINUED)

Pausing Therapy Using the Trigger Button If you choose to save the
The therapy can be interrupted at any time by pressing the trigger current parameters as a
button on the handpiece. When the trigger button is pressed, the user protocol, press the
following occurs: Save Protocol button and
follow the instructions on
• the applicator stops emitting radial pressure wave energy page 51 beginning with
• the symbol continues to display step 4.
To resume therapy, press the trigger button on the handpiece.
If you choose to start
Completing the Therapy Session over with the same
When the unit has completed the set number of pulses: treatment, press the Run
this Treatment button. You
• the applicator stops emitting radial pressure wave energy are returned to the Home
• the message "Treatment has completed. Touch anywhere to Screen with the same
continue . . ." parameters displayed.
• the unit sounds three long tones
If you choose to save the
current parameters to a
patient card, press the Save
to Patient Card button and
follow the instructions on
page 61, beginning with
step 2.

48
OPERATION Intelect® RPW

USING CLINICAL PROTOCOLS

The indications contained in this section are to be used only as guidelines. Each patient should be individually assessed to determine the
appropriateness of the parameter setting prior to use.
1. Make sure the MMC 4. If applicable, press the
labeled "RPW Clinical and buttons to
Resource Library" is scroll through the pages of
inserted into the MMC protocols.
port.
5. Press the protocol to
2. On the Home screen, highlight it, or press the
press the Clinical Protocols and buttons to scroll
button. The Clinical through the list.
Protocols screen displays.
6. Press the button to
accept the highlighted
selection. The suggested
3. Press the specific body area parameters, transmitter,
on the front or back image and placement information
to select the desired body displays.
area to treat. The screen
unique to the area of the 7. To select this protocol and
body you pressed displays. begin treatment, press the
button. The Home
screen displays and you
can begin treatment.

49
OPERATION Intelect® RPW

USING CLINICAL PROTOCOLS (CONTINUED)

8. If you want to change 12. Press the START button to
the protocol (e.g. the begin treatment.
recommended transmitter
does not match the 13. Press the trigger button to
handpiece you are using), activate the handpiece.
press the Alternate Protocol
button. The next Clinical
Protocols screen displays.

9. Press the button. The

Home screen displays with
the new parameters.

10. Press the and

buttons to set the
appropriate output power
for treatment.

11. Press the EDIT button to

change the parameters.

50
OPERATION Intelect® RPW

RETRIEVING, DELETING, AND SAVING USER PROTOCOLS

The Intelect RPW unit allows you to tailor a protocol according to the requirements of a patient. The treatment parameters selected at the
home screen can be saved as a new user protocol or saved to replace a previously saved user protocol. You may create up to 200 user
protocols.

Retrieving User Protocols Deleting User Protocols

1. On the Home screen, press 1. To delete the highlighted
the User Protocols button. user protocol, press the
The User Protocols screen Delete button on the
displays. Retrieve Protocol screen. A
message displays to verify
2. Press the Retrieve Protocol the deletion.
button. The Retrieve
Protocol screen displays. 2. Press the Yes button to
delete the user protocol.
3. Press or scroll to the You are returned to the
desired user protocol Retrieve Protocol screen.
to view the treatment
NOTE: If you press Yes,
parameters.
the user protocol
4. Press to select the name and
highlighted protocol. You parameters will
are returned to the Home be permanently
screen to begin treatment. removed from
the unit.

51
OPERATION Intelect® RPW

RETRIEVING, DELETING, AND SAVING USER PROTOCOLS (CONTINUED)

3. Press the No button to 4. To create a name for
keep the user protocol the new protocol, press
and return to the Retrieve the Save Protocol as a
Protocol screen. New Name button. The
Keyboard screen displays.
Saving New User Protocols
1. Set up treatment
parameters by completing
the steps listed in "Starting
Therapy" on pages 40-42, 5. Type the name of the new
but do not press the START protocol. The name of
button. the new protocol can be
up to 25 alpha-numeric
2. On the Home screen, press characters.
the User Protocols button.
The User Protocols screen
displays.

3. Press Save Protocol. The

Save Protocol screen
displays.

52
OPERATION
RETRIEVING, DELETING, AND SAVING USER PROTOCOLS (CONTINUED)
6. Press the button
to save the name of the
protocol. A message
displays briefly to confirm
the protocol was saved.
Press anywhere on the
screen. The Home screen
displays the parameters of
the user protocol you just
saved.
Editing Existing User Protocols
1. To edit the treatment
parameters of a previously
saved user protocol, press
to highlight, or scroll
through the list of user
protocols and highlight the
appropriate user protocol.
53
Intelect® RPW
2. Press the button to
save the new treatment
parameters. A message
displays to confirm the
overwriting of the old
parameters. If you press
Yes, a message displays
briefly to confirm the
protocol was saved and
the Home screen displays
the parameters of the
user protocol you just
saved. If you press No, you
are returned to the Save
Protocol screen.
OPERATION Intelect® RPW

USING CLINICAL RESOURCES - EDUCATIONAL LIBRARIES

The Educational Libraries can be accessed by pressing the button with the icon (Clinical Resources button) located below the touch
screen display. The Clinical Resources screen allows you access to the Educational Libraries, Patient Card management, and Utilities screens.

Anatomical Graphics Library 2. Press the button of the

The Anatomical Graphics Library features graphical images of the body area on which you
human anatomy and pathological conditions for which radial intend to administer
pressure wave is used. To access the Anatomical Graphics Library, therapy. The screen that
make sure the MMC labeled "SWD Clinical Resource Library" is in corresponds to the body
the MMC port and do the following: area you selected displays.
For example, you may
1. On the Clinical Resources have pressed the back
screen, press the of the neck which would
Anatomical Graphics cause the Neck: Page 1 of 2
Library button. The screen to display.
Anatomical Graphical
Library screen displays. 3. If available, press the
icon to display
additional pathological
images.

54
OPERATION
USING CLINICAL RESOURCES - EDUCATIONAL LIBRARIES (CONTINUED)
4. Press a button on the
left side of the screen
(Anatomical Images) to
display a list of either
muscles or bones that
make up the area.
5. Press the button to
return to the previous
screen.
6. Press a button on the
right side of the screen
(Pathological Images)
to display an illustration
of a common disorder
associated with the body
area.
7. Press the button to
return to the previous
screen.
55
Intelect® RPW
Handpiece Placement Library
The Handpiece Placement Library serves as a guideline for the
placement of transmitters for radial pressure wave treatment.
1. On the Clinical Resources
screen, press the
Handpiece Placement
Library button. The Select
Treatment Area screen
displays.
2. Press the body area on
which you intend to
administer therapy. The
screen that corresponds to
the body area you selected
displays. For example, if you
press the foot, the Hand
Piece Placement: Foot
displays.
OPERATION Intelect® RPW

USING CLINICAL RESOURCES - EDUCATIONAL LIBRARIES (CONTINUED)

3. Press one of the handpiece
placement thumbnails to
view the entire picture of
the handpiece placement.
The Handpiece Placement
screen displays.

4. Press the button to

return to the previous
screen.

5. Press the button to

return to the Home screen.

56
OPERATION Intelect® RPW

USING CLINICAL RESOURCES - EDUCATIONAL LIBRARIES (CONTINUED)

Viewing Rationale
Pressing the Shockwave Rationale button displays an overview of
radial pressure wave, a list of available treatment options, and a
synopsis of the available parameters.
1. On the Clinical Resources
screen, press the
Shockwave Rationale
button. The Shockwave
Rationale screen displays.
Viewing Contraindications
Pressing the Contraindications button displays a list of conditions
for which radial pressure wave therapy is contraindicated.
1. On the Clinical Resources
screen, press the
Contraindications button.
The Contraindications
screen displays.

2. Press the and

2. Press the and buttons to scroll through
buttons to scroll through the information.
the information.
3. Press the button
3. Press the button to to return to the
return to the previous previous screen.
screen.
4. Press the button
4. Press the button to to return to the
return to the Home screen. Home screen.
57
OPERATION Intelect® RPW

USING CLINICAL RESOURCES - PATIENT CARD

The Patient Card buttons serve to manage the information stored on a patient's data card.
NOTE: This button is only active when a patient card is inserted into the patient card port on the device.
Viewing and Retrieving Treatments from the Patient 3. Press the and
Card buttons if the number of
Press the Patient Card button to access the patient treatment data treatment sessions extend
stored on the patient card. beyond one page.

1. On the Clinical Resources 4. Press the button

screen, press the Patient to select the treatment
Card button. The Patient session. The treatment
Card screen displays. parameter screen displays.

5. Review the parameters of

the treatment session.

6. Press the Run this

2. Press the and Treatment button to begin
buttons to scroll through treatment.
the treatment sessions. The
treatment parameters for
the highlighted treatment
display at the top of the
screen.

58
OPERATION Intelect® RPW

USING CLINICAL RESOURCES - PATIENT CARD (CONTINUED)

Editing the Pain Profile 2. In the Pain Before
The Edit Pain Profile button allows access to the screen for pain Treatment section, press to
information to be saved to the patient card while a therapy session select either a Numeric or
is in progress. This information includes: Visual pain scale.
• Pain Scale before treatment 3. Press the button to
• Pain Scale after treatment decrease the amount of
• Pain Type before treatment pain on the scale.
• Pain Type after treatment
• Pain Map before treatment 4. Press the button to
• Pain Map after treatment increase the amount of
• Treatment Area pain on the scale.

1. On the Clinical Resources 5. Press the Pain Type button.

screen, press the Edit Pain
Profile button. The Edit Pain
Profile screen displays.
6. Press the pain type or use
The Select Pain Type Before
Treatment screen displays.
the , , and
buttons to select the pain
type. You are returned to
the Edit Pain Profile screen
with the new pain type
selected.

59
OPERATION Intelect® RPW

USING CLINICAL RESOURCES - PATIENT CARD (CONTINUED)

7. Press the Edit Pain Map 12. Press the Treatment
button. The Pain Map Area screen. The Select
Before Treatment screen Treatment Area screen
displays. displays.

8. Press the body area on

which you intend to
administer therapy. A
purple shading displays in
the areas you press.
13. Press the specific body
9. Press the Clear button area on the front or back
to remove all the areas image to select the desired
previously selected in the body area to treat. You are
previous step. returned to the Edit Pain
Profile screen.
10. Press the button to
return to the previous
screen.

11. In the Pain After Treatment

section, repeat steps 2-10.

60
OPERATION Intelect® RPW

USING CLINICAL RESOURCES - PATIENT CARD (CONTINUED)

14. Press the Save to Patient
Card to save the pain
information to the patient's
card.

15. Press the button

to return to the Clinical
Resources screen.

16. Press the button to

return to the Home screen.

61
OPERATION Intelect® RPW

USING CLINICAL RESOURCES - PATIENT CARD (CONTINUED)

Saving Treatments to the Patient Card
If the treatment time expires during a treatment, or if you stop a
treatment using the STOP button, the unit gives you the option of
saving the treatment to a patient card.

1. Press the Save to Patient

Card button when
prompted.

2. Follow steps 2-13 on pages

58-60.

3. When you press the Save

to Patient Card button, the
message "Treatment has
been saved for (patient
name)" briefly displays.

62
OPERATION Intelect® RPW

USING CLINICAL RESOURCES - PATIENT CARD (CONTINUED)

Erasing Patient Card
Use this button to remove all information on the Patient Card.
1. To delete all information on
the Patient Card, insert the
patient card to be erased
into the Patient Data Card
Port.
NOTE: By pressing the
Yes button, you
will permanently
remove all data on
the Patient Card.
You are returned to the
Clinical Resources Screen.

2. Press the Erase Patient Card

button. A message displays
to verify the deletion.

Press the No button if you

do not want to erase all the
information on the Patient
Card. You are returned
to the Clinical Resources
screen.
Press the Yes button to
erase all the information on
the Patient Card.

63
OPERATION Intelect® RPW

USING CLINICAL RESOURCES - UNIT SETTINGS

To access the Unit Settings screen, press the Unit Settings button on the Clinical Resources screen. The version number of the software
appears at the top of the screen.
Adding and Changing the Clinic Name
1. On the Clinical Resources
screen, press the Unit
Settings button. The Unit
Setup screen displays.
2. On the Unit Setup screen,
press the Clinic Name
button. The Keyboard
screen displays.
3. Type the name of the new
protocol. The name of the
protocol can be up to 25
alpha-numeric characters.
5. Press the button to
delete the new information
you may have entered and
return to the Unit Settings
screen.
Increasing and Decreasing the Unit Volume
On the Unit Settings screen, press the Volume button repeatedly
until the appropriate volume level displays. Each time you press the
Volume button, a tone sounds at the volume level displayed. The
volume will remain at the same level, even after powering the unit
off.

4. Press the button

to save the name of the
protocol and return to the
Unit Settings screen.

64
OPERATION Intelect® RPW

USING CLINICAL RESOURCES - UNIT SETTINGS (CONTINUED)

Setting the Date and Time Resetting Unit Settings
This button resets settings such as the language, volume, and clinic
1. On the Unit Settings name back to the original factory defaults.
screen, press the Set Date
and Time button. The Set 1. On the Unit Settings
Date and Time screen screen, press the Reset Unit
displays. Settings button. The reset
message displays.

2. Touch anywhere on the

LCD. You are returned to
the Unit Settings screen.

2. Press the and Resetting Default

buttons to set the year, Protocols
month, day, hour, and
minute. 1. To reset all user protocols
to the default parameters,
3. Press the button to press the Reset Default
save the date and time Protocols button. A
settings you entered and message displays to verify
return to the Unit Settings the reset.
screen.

65
OPERATION Intelect® RPW

USING CLINICAL RESOURCES - UNIT SETTINGS (CONTINUED)

Press the No button if Changing Languages
you do not reset all the
user protocols to the
default parameters. You
are returned to the Unit
Settings screen.
1. On the Unit Settings
screen, press the Language
button. The Language
screen displays.

Press the Yes button to 2. Press the and

reset all user protocols to buttons to scroll through
the default parameters. the pages of available
NOTE: By pressing the languages.
Yes button, you
will permanently 3. Press the language to
remove user highlight it, or press the
protocols you may and buttons to scroll
have created. through the list.

You are returned to the 4. Press the button to

Unit Settings Screen. accept the highlighted
selection. You are returned
to the Unit Setup screen.

66
OPERATION
USING CLINICAL RESOURCES - UNIT SETTINGS (CONTINUED)
Notice that all the buttons
are now in the new
language you selected.
Editing the Default Transmitters for Channels
1. On the Unit Settings
screen, press the Ch1
Default Transmitter button.
The Select Transmitter
screen displays.
67
Intelect® RPW
2. Press the transmitter to
highlight it, or press the
and buttons to
scroll through a list of the
available transmitters.
3. Press the Transmitter
Information button to
display technical details of
the transmitter.
4. Press the button to
accept the highlighted
selection and return to the
Edit Treatment screen.
5. Press the button to
return to the previous
screen.
OPERATION Intelect® RPW

USING CLINICAL RESOURCES - UNIT SETTINGS (CONTINUED)

6. If you choose to use a NOTE: Projectiles and guide tubes should be changed after
second handpiece during 1,000,000 pulses.
therapy, repeat steps To display the pulse count, do the following:
1-5 for the Ch2 Default
Transmitter button. 1. On the Unit Settings
screen, press the Pulse
Counter button. The Pulse
Counter screen displays.
Resetting the Pulse Counter
The Pulse Counter function allows the unit to track the number of
pulses for the transmitters for maintenance purposes. After a certain
number of pulses, the projectile must be replaced. For instructions
on replacing the projectile, see page 76.
The pulse counter monitors the number of pulses for a transmitter
that is connected to the same socket for each therapy session. For
2. Press the Reset button
example, if you keep the R-SW connected to Channel 1, the pulse
beside the desired
counter tracks the number of pulses for the R-SW in Channel 1. The
transmitter to reset the
pulse counter will also monitor the number of pulses for a different
counter to zero.
transmitter as long as it is always connected to the same socket.
However, the unit cannot track the number of pulses if the sockets
and transmitters are swapped (i.e., the R-SW is connected to
Channel 2). Therefore, you must connect the transmitters to the
same sockets each therapy session in order for the pulse counter to
be accurate.
68
OPERATION Intelect® RPW

USING CLINICAL RESOURCES - UNIT SETTINGS (CONTINUED)

3. Press the Reset All button
to reset all the pulse
counters to zero.

69
OPERATION Intelect® RPW
TREATMENT TIPS
The applicator is placed over the previously diagnosed pain region. Holding the Handpiece as a Pen
To start and stop shock wave application, the trigger button The handpiece is held
provided on the applicator must be pressed behind the rear cap.
Keep in mind the following: This way of holding the
• Do not apply more than 300 pulses to the same spot. applicator is recommended
• Avoid pressing the transmitter into the treatment area with for tactile treatment.
excessive pressure. Excessive pressure is not needed for
effective and successful treatment.
• Stop treatment after a maximum of 6000 pulses.
Positioning the Handpiece
Position the handpiece on the part of the body to be treated
according to the medical indication.
Holding the Handpiece as a Bar

WARNING
The handpiece is grasped
with the entire hand
behind the rear cap.
Operating the unit at pressures higher than 3 bar without an impact This way of holding the
surface can result in damage to the handset. applicator is recommended
for the treatment of pain
regions covering relatively
large areas.

70
OPERATION Intelect® RPW
TREATMENT TIPS (CONTINUED)
Using Both Hands to Hold the Handpiece
This way of holding the
applicator is recommended
for the treatment of pain
confined to specific points.

71
TROUBLESHOOTING Intelect® RPW

ERRORS
Error Codes and Descriptions
Error Description Error Description
Code Code
100 The Patient Card button was pressed, but no valid treatments 109 The MMC is being accessed, but there is no MMC inserted into
were found on the Patient Card. the MMC port.
101 The Save to Patient Card button was pressed, but there is no 110 The user is attempting to update the unit's software, but the
Patient Card inserted. MMC inserted into the MMC port is not a software update MMC.
102 The Save to Patient Card button was pressed, but the card that 111 There was an error encountered when attempting to update
is currently inserted in the Patient Data Card Port is not a valid the control board software.
patient data card.
112 There was an error encountered when attempting to update
103 The Save to Patient Card button was pressed, but the card that the interface board software.
is currently inserted in the Patient Data Card Port is full.
113 The treatment being accessed on the Patient Card is a traction
104 The Save to Patient Card button was pressed, but there is type of treatment.
already a treatment by that name on the Patient Card.
114 The treatment being accessed on the Patient Card is an
105 No patient name was entered when the Save to Patient Card electrotherapy type of treatment.
button was pressed.
115 The treatment being accessed on the Patient Card is a
106 No protocol name was entered when attempting to save a continuous passive motion (CPM) type of treatment.
protocol.
116 The treatment being accessed on the Patient Card is a
107 The Retrieve Protocol button was pressed, but no user protocols shortwave diathermy type of treatment.
have been set up in the unit. Refer to page 51 for more
117 The treatment being accessed on the Patient Card is an
information about saving user protocols.
unknown type of treatment.
108 The protocol cannot be saved because the unit has the
maximum number of protocols already saved.

72
TROUBLESHOOTING Intelect® RPW
ERRORS (CONTINUED)

WARNING
Error Description
Code
118 A button was pressed that accessed the MMC card (e.g., Radial
Pressure Wave Rationale, Contraindications, etc.), but the MMC In the event that an Error message or Warning appears beginning with
inserted into the MMC port is not the correct MMC. 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
119 The Delete button was pressed while a default (factory) protocol internal problem with the unit that must be tested by DJO or a Field
was highlighted. Service Technician certified by DJO before any further operation or use
121 The START button was pressed, but a handpiece cable is not of the system.
connected to any output socket.
Use of a unit that indicates an Error or Warning in these categories
122 The START button was pressed, but a handpiece cable is not may pose a risk of injury to the patient, user, or extensive internal
connected to the Channel 1 output socket. damage to the system.
123 The START button was pressed, but a handpiece cable is not
connected to the Channel 2 output socket.
124 The user is attempting to use the wrong transmitter for the

WARNING
selected protocol.
125 The transmitter in Channel 1 has reached one million pulses.
126 The transmitter in Channel 2 has reached one million pulses. In case of display failure or other obvious defects, switch the unit
127 The handpiece cable has become disconnected from the off immediately by means of the Power On/Off button and notify a
output socket during a therapy session. certified service technician.

73
MAINTENANCE Intelect® RPW

MAINTAINING THE INTELECT RPW

Routine Maintenance
Keep in mind the following when maintaining the unit:
• As the manufacturer, DJO is responsible for the safety and
reliability of the unit only if it is used in accordance with this
user manual.
• Safety inspections, maintenance, repairs, and modifications
may be performed only by a certified service center or field
technician certified by DJO.
Cleaning and Disinfection
When cleaning the unit, keep in mind the following:
1. Unplug the unit and remove
the handpiece cable from the
socket on the unit.
2. Wipe off excess coupling gel
from the transmitter.
3. Clean the base unit using a
soft, clean cloth dampened
with water and a mild
antibacterial detergent. Avoid
the use of abrasive materials
and cleaning solvents.
4. After each patient use,
clean the R-SW handpiece
(remove the front and rear
caps first - page 28). Use a
soft, clean cloth dampened
with alcohol, an alcohol-
based surface cleaning
wipe, or a mild antibacterial
detergent. Avoid the use
of abrasive materials and
cleaning solvents. See
steps 7 and 8 on page 74
for more information on
cleaning the transmitter.
5. To clean the handle,
remove the protective
cushion by pulling it up
and off the handle. Use a
soft, clean cloth dampened
with water or a mild
antibacterial detergent
to wipe off the handle.
Avoid the use of abrasive
materials and cleaning
solvents
74
MAINTENANCE
MAINTAINING THE INTELECT RPW (CONTINUED)
6. Wait until the unit is
completely dry before
operating it again.
7. It is recommended that
the transmitters be
cleaned with an ultrasound
cleaning bath designed
for disinfecting heat-
sensitive, reusable medical
instruments. If an ultrasonic
bath is unavailable, clean
parts under running water
and wipe with an alcohol-
based surface cleaner wipe,
or spray with alcohol-based
surface cleaner and wipe
with a soft, clean cloth.
75
Intelect® RPW
8. When cleaning the
transmitter, push aside
the spacer ring so that
the interior cavity can be
cleaned.
9. Re-assemble the transmitter and handpiece by reversing
the procedures in steps 4 and 3.
Hand piece Maintenance
Frequent cleaning is recommended ( After everyday of usage)
Technique
Please use cleaning brush provided with hand piece kit to clean
guide tube similar to that of cleaning a gun barrel. Also, hand clean
with soft cloth projectile.
Caution: Do not use any lubricant when cleaning tube or projectile.
MAINTENANCE Intelect® RPW

MAINTAINING THE INTELECT RPW (CONTINUED)

10. Removing and Replacing the Water Bottle 4. Hold the cap, turn the
bottle counter clockwise,
You must empty the water bottle at least once a week and when
and remove the cap.
the bottle is half full. To do this, do the following:
5. Empty the contents of the
1. Unplug the unit from the
bottle.
Mains Power.

2. Pull out the drawer.

6. Replace the bottle by

holding the cap and
turning the bottle
clockwise.
3. Slide the water bottle out
of the holding bracket.

76
MAINTENANCE
MAINTAINING THE INTELECT RPW (CONTINUED)
7. Slide the water bottle back
into the holding bracket.
8. Push in the drawer.
77
Intelect® RPW
Replacing the Projectile and Guide Tube
Projectiles and guide tubes should be changed after 1,000,000
pulses. To change the transmitter, do the following:
1. Unplug the unit and
remove the handpiece
cable from the socket on
the unit.
2. Unscrew the rear cap by
turning it counterclockwise
and holding the handpiece.
MAINTENANCE
MAINTAINING THE INTELECT RPW (CONTINUED)
3. Unscrew the shaft from the
handpiece by turning it
counterclockwise.
NOTE: Use the supplied
22 mm open-
face wrench if
necessary.
4. Remove the shaft from the
handpiece housing.
78
Intelect® RPW
5. The projectile may be
laying inside the handle.
Place your hand over the
hole in the handle and turn
it over so that the projectile
falls out in your hand.
If the projectile is in the
shaft, place your hand over
the open end of the shaft
and turn it over so that the
projectile falls out in your
hand.
NOTE: Make certain
that the entire
projectile is
retrieved. It may
have broke apart
during use.
MAINTENANCE Intelect® RPW

MAINTAINING THE INTELECT RPW (CONTINUED)

6. Slide the long end of the hex wrench through the hole in the guide tube.

7. While holding the shaft with one hand, pull the guide tube out of the shaft with the other hand.
NOTE: The guide tube will be tightly fitted into the shaft, so you will need to pull hard to remove it.

8. Dispose of the used projectile.

9. Clean the outside of the shaft, transmitter, and screw cap using a soft, clean cloth dampened with
water or a mild antibacterial detergent. Avoid the use of abrasive materials and cleaning solvents.
NOTE: Wait until the cleaned components are dry before continuing with step 10.

10. Clean the inside of the shaft (tube) with the cleaning brush provided with hand piece kit. Cleaning
should be performed after each day of usage.

Note: Do not use any lubricant with cleaning of handpiece.

79
MAINTENANCE Intelect® RPW

MAINTAINING THE INTELECT RPW (CONTINUED)

11. If necessary, replace the red 13. Press the guide tube into
sealing sleeve by pressing the shaft until it seats.
it into the opening of the
shaft until it hits the stop.

12. Insert the new guide tube 14. Insert the new projectile
into the shaft. into the guide tube.
NOTE: Make certain to
insert the end of
the guide tube
without the holes
into the shaft.

80
MAINTENANCE Intelect® RPW

MAINTAINING THE INTELECT RPW (CONTINUED)

15. Insert the shaft into the 17. Reattach the rear cap by
handle and turn clockwise turning it clockwise and
until snug. holding the handpiece.

18. Plug in the unit and

connect the handpiece
cable to the output socket
on the unit.

19. Reset the pulse counter

by following the steps
16. Use one hand to hold the beginning on page 67.
handle and the other hand
to tighten the shaft into
the handle using the 22
mm open face wrench. DANGER
NOTE: Tighten the shaft If the unit is not safe for operation, it must be repaired by a certified
so that you are service technician and the operators must be informed of the
not able to loosen dangers posed by the unit.
the shaft with
your hand.

81
MAINTENANCE Intelect® RPW

MAINTAINING THE INTELECT RPW (CONTINUED)

DANGER Functional Test (Daily)

• Under no circumstances may liquid penetrate the openings
on the unit (e.g. the connecting sockets of the handset cables).
Therefore, do not use cleaning or disinfectant sprays.
• The unit, handpiece, 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 LCD or otherwise damage the unit.
• In order to prevent electrical shock, unplug the power plug from
the power outlet before cleaning or disinfecting the unit.
When performing daily inspections of the unit, pay particular
attention the following areas of potential damage:
• Correct function of indicators
• Display of operating modes
NOTE: It is the responsibility of the health care facility to
verify that the unit complies with the facility, local, and
national Earth Leakage limits.

Safety Inspections
The following safety inspections must be performed on this unit.
This must be done by persons who, based on training, knowledge
or practical experience, are capable of conducting the inspections
correctly and independently.
Visual Inspection (Daily)
When performing daily inspections of the unit, pay particular
attention the following areas of potential damage:
• Deformation of unit housing
• Power cable damage
• Handpiece connection damage
• Handpiece cable damage
82
MAINTENANCE Intelect® RPW
MAINTAINING THE INTELECT RPW (CONTINUED)
Service

DANGER
Do not perform unauthorized repairs under any circumstances.
Return unit to DJO for servicing.

The Intelect RPW unit must be recalibrated if it is not operating within

specifications after routine maintenance and safety inspections have been
performed. It is recommended that all
DJO radial pressure wave treatment products be returned to the factory or a
certified servicing dealer for repairs or recalibration. Should the unit require service,
warranty, or repair, please contact the selling dealer or your local DJO customer
service.
NOTE: The unit was calibrated during the manufacturing process and is ready
to be placed into service upon delivery.
Council Directive 2002/96/EC concerning Waste Electrical and
Electronic Equipment (WEEE). Indicates a requirement not
to dispose of WEEE as municipal waste. Contact your local
distributor for information regarding disposal of the unit and
accessories.

83
ACCESSORIES Intelect® RPW

STANDARD ACCESSORIES
REF. Description Qty REF. Description Qty
28668 Intelect RPW CD User Manual 1 One of the following power cords:
28671 Intelect RPW Quick Start Guide 1 14679 US [18 AWG, 118 in (300 cm)] 1
4248 Conductor™ Transmission Gel-250 ml (8.5 oz) bottle 1 14814 Switzerland [18 AWG, 118 in (300 cm)] 1
28700 Standard Accessory Kit that Includes the following: 1 14815 UK [18 AWG, 118 in (300 cm)] 1
28699 D-ACTOR (R-SW) Handpiece Applicator 1 14816 India [18 AWG, 118 in (300 cm)] 1
28736 Projectile 3 14817 Israel [18 AWG, 118 in (300 cm)] 1
17638 R15 - 15 mm ESWT Transmitter 1
14818 Denmark [18 AWG, 118 in (300 cm)] 1
28724 D20-S D-ACTOR® 20 mm Transmitter 1
14819 Austrailia [18 AWG, 118 in (300 cm)] 1
28737 Sealing Set 1
14820 EU [18 AWG, 118 in (300 cm)] 1
28738 Guide Tube 2
14821 Japan [18 AWG, 118 in (300 cm)] 1
28739 Cleaning Brush 1

NOTE: The power cord shipped with the unit will

accommodate the electrical requirements for
the country of use.
OPTIONAL ACCESSORIES
REF. Description Qty REF. Description Qty
28701 Revision kit which includes replacement guide tube and 2 projectiles 1 28730 V-ACTOR® hand piece applicator Kit that includes the following: 1
28725 D35 D-ACTOR® 35 mm Transmitter 1 28740 V25 V-ACTOR® 25 mm Vibration Transmitter 1
28726 F15 Focus-Lens 15 mm Transmitter 1 28741 V40 V-ACTOR® 40 mm Vibration Transmitter 1
28728 D15 Deep Impact® 15 mm Transmitter 1 28742 Red Sealing Sleeve 1
28729 C15 CERAma-x® ESWT 15 mm Transmitter 1

84
WARRANTY Intelect® RPW

DJO, LLC, ("Company") warrants that the Intelect RPW ("Product") is free of defects in material and workmanship. This warranty shall remain in effect for three years fom the date of original consumer
purchase. If this Product fails to function during the three year warranty period due to a defect in material or workmanship, at the Company's Option, Company or the selling dealer will repair or
replace this Product without charge.

All repairs to the Product must be performed by a service center certified by the Company. Any modifications or repairs performed by unauthorized centers or groups will void this warranty.
The warranty period for accessories is 365 days or 5 Million Shocks.

This Warranty Does Not Cover:

• Replacement parts or labor furnished by anyone other than the Company, the selling dealer or a certified Company service technician.
• Defects or damage caused by labor furnished by someone other than Company, the selling dealer or a certified Company service technician.
• Any malfunction or failure in the Product caused by product misuse, including, but not limited to, the failure to provide reasonable and necessary maintenance or any use that is
inconsistent with the Product User's Manual.
• DJO, LLC is not responsible for injury or damage resulting from modifications or service performed by non-authorized DJO, LLC service personnel.
COMPANY SHALL NOT BE LIABLE IN ANY EVENT FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES.
Some areas do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation or exclusion may not apply to you.
To obtain service from Company or the selling dealer under this warranty:
1. A written claim must be made within the warranty period to the Company or the selling dealer.

2. The Product must be returned to the Company or the selling dealer by the owner.

This warranty gives you specific legal rights and you may also have other rights which vary from region to region.

The Company does not authorize any person or representative to create for it any other obligation or liability in connection with the sale of the Product. Any representation or agreement not
contained in the warranty shall be void and of no effect.

THE FOREGOING WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED,

INCLUDING ANY WARRANTY OR MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

85
APPENDIX A - EMC TABLES Intelect® RPW

TABLE 1: GUIDANCE AND MANUFACTURER’S DECLARATION–ELECTROMAGNETIC EMISSIONS

The Intelect RPW unit is intended for use in the electromagnetic environment specified in the table below. The user of the Intelect RPW
unit should assure that it is used in such an environment.

Emission Tests Compliance Electromagnetic Environment - Guidance

RF emissions The Intelect RPW uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby
Group 1
CISPR 11 electronic equipment
RF emissions
Class A
CISPR 11
Harmonic emissions
Class A The Intelect RPW is suitable for use in all establishments, other than domestic, and those directly connected to the public low-voltage power supply network
IEC 61000-3-2 that supplies buildings used for domestic purposes.
Voltage fluctuations/Flicker
Emissions Complies
IEC 61000-3-3

86
APPENDIX A - EMC TABLES Intelect® RPW

TABLE 2: GUIDANCE AND MANUFACTURER’S DECLARATION–ELECTROMAGNETIC IMMUNITY

The Intelect RPW unit is intended for use in the electromagnetic environment specified in the table below. The user of the Intelect RPW
should assure that it is used in such an environment.

IEC 60601
Immunity Test Compliance Level Electromagnetic Environment - Guidance
Test Level
Electrostatic discharge (ESD) ±6 kV contact ±6 kV contact Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative
IEC 61000-4-2 ±8 kV air ±8 kV air humidity should be at least 30%.
Electrical fast transient/burst ±2 kV for power supply lines ±2 kV for power supply lines Mains power quality should be that of a typical commercial or hospital environment.
IEC 61000-4-4 ±1 kV for input/output lines N/A - No Input/Output lines
Surge ±1 kV differential mode ±1 kV differential mode Mains power quality should be that of a typical commercial or hospital environment.
IEC 61000-4-5 ±2 kV common mode ±2 kV common mode
Voltage dips, short <5% UT <5% UT Mains power quality should be that of a typical commercial or hospital environment. If the user of the
interruptions and voltage (>95% dip in UT) for 0.5 cycle (>95% dip in UT) for 0.5 cycle Intelect RPW requires continued operation during power mains interruptions, it is recommended that the
variations on power supply 40% UT 40% UT Intelect RPW be powered from an uninterrupted power supply or a battery.
input lines (60% dip in UT) for 5 cycles (60% dip in UT) for 5 cycles
IEC 61000-4-11 70% UT 70% UT
(30% dip in UT) for 25 cycles (30% dip in UT) for 25 cycles
<5% UT <5% UT
(>95% dip in UT) for 5 sec (>95% dip in UT) for 5 sec
Power frequency (50/60Hz) 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical
magnetic field commercial or hospital environment.
IEC 61000-4-8

NOTE: UT is the a.c. mains voltage prior to application of the test level.

87
APPENDIX A - EMC TABLES Intelect® RPW

TABLE 2: GUIDANCE AND MANUFACTURER’S DECLARATION–ELECTROMAGNETIC IMMUNITY (CONTINUED)

The Intelect RPW unit is intended for use in the electromagnetic environment specified in the table below. The user of the Intelect RPW
unit should assure that it is used in such an environment.
Immunity IEC 60601
Compliance Level Electromagnetic Environment - Guidance
Test Test Level
Portable and mobile RF communications equipment should be used no closer to any part of the Intelect RPW, including cables, than the
recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance:
Conducted RF 3 Vrms 3 Vrms d = [3.5]√P
IEC 61000-4-6 150 kHz to 80 MHz V1
Radiated RF 3 V/m 3 V/m d = [3.5]√P 80 MHz to 800 MHz
IEC 61000-4-3 80 MHz to 2.5 GHz E1
d = [7]√P 800 MHz to 2.5 GHz
E1
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each
frequency rangeb.
Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast
and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in which the Intelect RPW is used exceeds the applicable RF compliance level above, the Intelect RPW
should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Intelect
RPW.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
88
APPENDIX A - EMC TABLES Intelect® RPW

TABLE 3: RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF

COMMUNICATIONS EQUIPMENT AND THE INTELECT RPW
The Intelect RPW unit is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The
customer or the user of the Intelect RPW can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the Intelect RPW as recommended below, according to the
maximum output power of the communications equipment.

Separation Distance According to Frequency of Transmitter

Rated Maximum Output Power of m
Transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
W d = [3.5]√P d = [3.5]√P d = [7]√P
V1 E1 E1
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the
equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
objects, and people.

89
 DJO France SAS
Centre Européen de Frêt
3 rue de Béthar
64990 Mouguerre, France
T: 1-800-592-7329 USA
T: + 1-317-406-2209
F: + 1-317-406-2014
0086 chattgroup.com
© 2017 DJO, LLC. All rights reserved.

28668_H English