Chattanooga Intellect RPW 2 User manual

EN
Quick Start Guide

2
INTELECT®RPW 2 QUICK START GUIDE
Foreword..................................................................
Intended User Profile...........................................
Intended Environment for Use........................
Intended Use...........................................................
Precautionary Instructions................................
Home Screen Icon descriptions......................
Description of Device Markings.....................
Pain in the Musculoskeletal System.............
Contraindications..................................................
Additional Precautions........................................
Adverse Eects.......................................................
Patient Applied Parts.........................................
Product Description............................................
Components..........................................................
IFU Download.......................................................
System Start-Up...................................................
Device Connected to the Mains....................
To stop treatment................................................
Caution.....................................................................
Warning....................................................................
Danger......................................................................
Unpacking the Device........................................
Device Description..............................................
Falcon Handpiece Setup.................................
Powering up the Device...................................
Operating Data and Ratings..........................
Falcon Handpiece Technical...........................
Specifications
Software..................................................................
Transport and Storage Conditions..............
Patient Preparation............................................
Treatment Tips.....................................................
CONTENTS

3
FOREWORD
This guide is intended for users of Intelect®RPW .
It contains general information on operation,
precautionary practices, and maintenance.
Before administering any treatment to a patient, the
users of this equipment should read, understand, and
follow the information contained in this guide 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 and Vibration
therapies.
INTENDED USER PROFILE
The intended user of this device is a licensed medical
professional trained to properly use the device:
Physical Therapist, Occupational Therapist, Athletic
Trainers, Chiropractors, Osteopaths, Orthotists,
Podiatrists, Sport’s Medicine Therapists and Medical
Doctors.
The device shall not be sold OTC to non professional
users
The user should be able to:
• Read and understand the operator’s manual,
warnings, cautions and dangers.
• Sense auditory and visual signals.
• Read and understand cautions and
contraindications of the device
• The operator shall operate only one device at
a time
and treat one patient at a time.
• The device is not intended to be operated by
the patient
INTENDED ENVIRONMENT FOR USE
The device is intended to be operated in a clinical
environment, it can be moved from room to room.
The device is not intended to be regularly transported
from one facility to another. It is not intended for
home use.
INTENDED USE
The Intelect RPW  device is intended to be used as a
therapeutic modality by clinicians needing to provide
patients with a powerful and proven method of
treating indications as pain, myofascial trigger points,
disorders of tendon insertions, activation of muscle
and connective tissue.
Individual results may vary. Neither DJO Global, Inc.
nor any of its subsidiaries dispense medical advice.
The contents of this document do not constitute
medical, legal, or any other type of professional advice.
Information related to various health, medical, and
fitness conditions and their treatment is not meant to
be a substitute for the advice provided by a physician
or other medical professional.

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INTELECT®RPW 2 QUICK START GUIDE
Text with a “WARNING” indicator explains possible
safety infractions that will potentially cause serious
injury and equipment damage.
Text with a “DANGER” indicator will explain possible
safety infractions that are imminently hazardous
situations that would result in death or serious injury.
WARNING
DANGER
PRECAUTIONARY INSTRUCTIONS
The precautionary instructions found in this section
and throughout this manual are indicated by specific
symbols. Understand these symbols and their
definitions before operating this equipment. The
definition of these symbols are as follows:
CAUTION
Text with a “CAUTION” indicator explains possible
safety infractions that have potential to cause minor
or moderate injury or damage to the equipment.

5
HOME SCREEN ICON DESCRIPTIONS
Falcon Radial Pressure Waves
handpiece
Vibration Therapy handpiece
V-Actor
Shortcut
SPS (Suggested Parameter Setup)
Custom Protocols
Treatment Data
Clinical Resources
Home
Settings
USB Drive
DESCRIPTION OF DEVICE MARKINGS
Refer to Instructional Manual
and Quick Start Guide Booklet
Warning, Caution, or Danger
Electrical Type B Equipment
Play
Pause
ON/OFF
Manufacturer
Date of manufacture
Catalogue number
Serial number
Fragile, handle with care
This end up
Keep dry
Temperature Range

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INTELECT®RPW 2 QUICK START GUIDE
Markings are conform to ISO7010 and ISO15-223-1"
Relative Humidity Range
Atmospheric Pressure Range
Testing agency
CE Mark of Conformity with
notified body number
Class 1 equipment
Radio frequency equipment
WEEE Directive conformity
Shelf life
Batch number
No condensation allowed
Read the instruction for use
AC Rated supply voltage

7
PAIN IN THE MUSCULOSKELETAL
SYSTEM
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 eects not
known at the time of manufacturing.
RPW therapy is indicated for the following:
Myofascial Trigger Points (MTrP)
Localizing and Deactivating Trigger Points
Triggers are localized at the low energy level
(approximately  bar) by passing the transmitter over
the muscle region being treated (increased sensitivity
to pain) and then deactivated using a higher energy
level (approximately  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

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INTELECT®RPW 2 QUICK START GUIDE
The Intelect®RPW  should NOT be used under the
following conditions:
• Brain or spinal column in the treatment area.
• On any body part during pregnancy.
• Direct application over cancerous tumors or
lesions due to its potential to increase blood
flow to the area of malignancy.
• Polyneuropathy area. A Diabetes patient often
experiences disturbed or reduced sensory and
nervous function in the polyneuropathic area.
• Cortisone therapy: Wait minimum 
weeks after local cortisone injection before
treatment with radial pressure waves.
• Haemophilia, Thrombosis, Deep vein
thrombosis, or other coagulation disorders.
• Anticoagulant pharmaceuticals.
• On any Neoplastic tissues or space occupying
lesions.
• Reduced thermal sensitivity over the
proposed area of treatment, unless the
physician in charge of the patient is notified.
• Pulses must not be applied to target areas
near large vessels, the spinal column or head
(apart from the face).
CONTRAINDICATIONS

9
ADDITIONAL PRECAUTIONS
When administering Radial Pressure Wave treatment,
keep in mind the following:
• Radial Pressure Wave treatment should
be applied with caution over bone where
minimal (bony prominence) or no (Stage IV
wounds) soft tissue is present.
• Hearing aids should be removed.
• The function of other patient connected
equipment may be adversely aected by the
operation of the pulsed radial pressure wave
equipment. Maintain maximum distance
between devices in order to reduce any
tendency to interaction. Refer to the EMC
tables at the end of this manual for more
information.
• Any bleeding tendency is increased by
heating because of the increase in blood flow
and vascularity of the heated 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
ADVERSE EFFECTS
Side eects could occur after a treatment with Radial
Pressure Wave therapy. The majority will appear after
- days. Do not repeat a treatment until the previous
side eects have diminished. Common side eects
include:
• Erythema, reddening
• Swelling
• Pain
• Hematoma
• Petechiae, red spots
• Skin lesions after previous cortisone therapy
• These side eects generally abate after  to
 days

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INTELECT®RPW 2 QUICK START GUIDE
PATIENT APPLIED PARTS
Transmitters Material Applied part Type
A6 Steel 1.4021 Type B
T10 Steel 1.4021 Type B
C15 Ceramic Volcera Type B
DI 15 Titan grade 5 ELI Type B
F15 PTFE Type B
D20-S Steel 1.4542 Type B
D35-S Steel 1.4542 Type B
D20-T Titan grade 5 ELI Type B
Ro40 Steel 1.4021 Type B
R15 Steel 1.4021 Type B
V10 POM-C LSG ( ACETRON) Type B
V25 POM-C LSG ( ACETRON) Type B
V40 POM-C LSG ( ACETRON) Type B
PERI ACTORS POM-C LSG ( ACETRON) Type B
SPINE ACTORS Polyvinylidenfluorid EpoFlon
– ECTFE (Halar) Type B
Ultrasonic gel Water de-ionized water
Gel (PH7) Type B

11
PRODUCT DESCRIPTION
The Intelect®RPW  is a compressed air-operated
ballistic shock wave generator. The shock waves
in the device are generated with a precision
ballistic mechanism in the handpiece. A projectile is
accelerated by compressed air. The motion and weight
of the projectile produce kinetic energy. When the
projectile impacts against an immovable surface, the
shock transmitter, this kinetic energy is converted into
sound energy. This acoustic pulse is transmitted into
the tissue to be treated directly with the help of a gel.
These waves are physically classified as radial pressure
waves. The applied pressure pulse propagates radially
within the tissue and has a therapeutic eect on areas
of the tissue near the surface.
Note: This equipment is to be used only by a licensed
medical practitioner.

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INTELECT®RPW 2 QUICK START GUIDE
Cable Holders
Gel Bottle
Gel for diagnostic and therapeutic medical procedures
should be water based with deionized water. No
formaldehyde, no fat. For external use only.
Pouch
COMPONENTS
Throughout these instructions the terms “left” and
“right” referring to the device sides are from the
perspective of a user standing in front of the device.
The components of the Intelect®RPW  are shown
below.
Falcon Handpiece
Gel Holder

13
IFU DOWNLOAD
. To download the IFU go to the Chattanooga website
www.chattanoogarehab.com
. Complete the registration to be informed of
software and IFU updates and register your device
. Select your INTELECT RPW  model
. Click download IFU to start the download
. A pdf viewer will be required to view IFU
SYSTEM START-UP
Complete the following steps for start-up of the
Intelect®RPW :
DEVICE CONNECTED TO THE MAINS
. Plug the power cord into the back of device. Plug the
other end of the cord into an electrical outlet.
Note: The Power Cord may be unplugged from the back
of the device in an emergency situation.
. Connect the Falcon handpiece on the right
connector.
. Turn on the power switch located on the back of
the device.
TO STOP TREATMENT
Press Play/Pause button to pause treatment then press
Stop on touch screen. If device is on mains power
press the On/O button on the front panel then turn
o the switch on the back of the device.
Trigger the handpiece or press Start/Pause button to
pause treatment then press Stop on touch screen. If
device is on mains power turn of the switch on the
back of the device.
Press and hold for
power o

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INTELECT®RPW 2 QUICK START GUIDE
• This device should be operated at °C to +°C and % to % Relative Humidity (no condensation).
The device should be transported and stored at -°C to +°C and % to % Relative Humidity (no
condensation).
• Atmospheric pressure requirements:  kPa to  kPa.
• The Falcon handpiece should be operated at °C to +°C and % to % Relative Humidity (no
condensation). The handpiece should be transported and stored at °C to +°C and % to % Relative
Humidity (no condensation).
• The V-Actor HF handpiece should be operated at °C to +°C and % to % Relative Humidity (no
condensation). The handpiece should be transported and stored at °C to +°C and % to % Relative
Humidity (no condensation).
• The time required for Intelect RPW  to warm from the minimum storage temperature between uses until
Intelect RPW  is ready for its intended use when the ambient temperature is °C is  hours.
• The time required for Intelect RPW  to cool from the maximum storage temperature between uses until
Intelect RPW  is ready for its Intended use when the ambient temperature is  °C is  hours
• Under single fault condition and extreme usage conditions, the maximum temperature of the hand piece
can reach °C. There is no particular health risk associated with this temperature besides your comfort.
• Use of parts or materials other than DJO’s can degrade minimum safety.
• Connect to this device only items and equipment that have been specified in this IFU as part of the Intelect
RPW  System or that have been specified as being compatible with the Intelect RPW  System.
• DO NOT disassemble, modify, or remodel the device or accessories. This may cause device damage,
malfunction, electrical shock, fire, or personal injury.
• Before using the therapy device, the operator must ascertain that it is in correct working order and
operating condition. The cables and connectors, in particular, must be checked for signs of damage. The
device cannot be used if any part is damaged as there is a risk of electrical shock.
• Before each use always oer the patient hearing protection.
• Apply a sucient amount of coupling gel to the patient’s skin in the treatment area and to the shock
transmitter.
• The maximum energy level used during treatment must not cause the patient undue pain under any
circumstances.
• DO NOT apply more than  shocks to the same spot during treatment.
• The surface of the transmitter can reach °C. Extended skin contact can cause minor burns. Interrupt
therapy after a maximum of  pulses to allow the transmitter to cool.
• Operating the device at pressures higher than  bar without an impact surface can result in damage to the
handset.
• To avoid a trip hazard, keep all accessories and their cords separated during treatment by using the hook
located on the side of the device.
• Disconnect the instrument from the mains before starting any cleaning or overhaul work.
CAUTION

15
CAUTION
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.
• This device should be used only by a physician or licensed practitioner.
• Contaminated transmitters, and gel can lead to infection. Disinfect the handpiece after each treatment.
• DO NOT use the Intelect RPW  in water (Bath, Shower, etc.) that could cause electronic failure
• DO NOT operate the Intelect RPW  within the vicinity or environment of any microwave and RF
shortwave diathermy system.
• DO NOT operate this device in an environment where other devices are being used that intentionally
radiate electromagnetic energy in an unshielded manner.
• To avoid the risk of electric shock, this equipment must only be connected to a supply mains with
protective earth.
• DO NOT apply more than  shocks to the same spot during treatment
• Avoid excessive pressure of the shock transmitter to the patient’s skin.
• DO NOT trigger pulses unless the pulse transmitter is in contact with the treatment zone.
• Portable RF communications equipment should be used no closer than  cm ( inches) to any part of the
Intelect RPW , including cables specified by the manufacturer. Otherwise, degradation of the performance
of this equipment could result.
• Use of accessories, handpieces and transmitters other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation.
• Device is designed to comply with electromagnetic safety standards. This equipment generates, uses, and
can radiate radio frequency energy and, if not installed and used in accordance with instructions for use,
may cause harmful interference to other devices in the vicinity. Harmful interference to other devices can
be determined by turning this equipment on and o. Try to correct the interference using one or more of
the following:
» Reorient or relocate the receiving device
• Danger of injury due to pulse triggering when handpiece is open.
• Disconnect the handpiece from the control device before starting any cleaning or maintenance work.
• There are no user-serviceable parts inside the device. If a malfunction occurs, discontinue use immediately
and contact your local DJO oce via www.djoglobal.com for assistance and service information.
• Do not use while sleeping or operating heavy equipment.

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INTELECT®RPW 2 QUICK START GUIDE
WARNING
» Increase the separation between the equipment
» Connect the equipment to an outlet on a dierent circuit from that to which the other device(s)
are connected
» Consult your authorized DJO dealer for help.
• No modification of this equipment is allowed
• The Intelect®RPW  may be susceptible to Electro-Static Discharge (ESD) at greater than ± kV when first
grasping either the Falcon or V actor hand piece. In the event of such a discharge, the Intelect®RPW  may
experience communication loss. The Intelect®RPW  will terminate all active outputs, automatically place
the device in a safe state.
• To prevent Electro-Static Discharge (ESD) at greater than ± kV:
»Grasp and hold the hand piece prior to starting treatment. If the applicator must be put down prior to
completion of treatment, stop the current treatment first and then place the applicator in the holder.
»Maintain humidity in the use environment to at least % relative humidity.
»Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, DJO
recommends implementing additional controls to maintain relative humidity to at least %.
»Communicate these ESD-precautionary procedures to healthcare sta, contractors, visitors, and
patients.
• DO NOT block the device's vents.
• Potential electromagnetic or other interference could occur to thsi or other equipment. Try to minimize
this interference by not using other equipment in conjunction with it.
DANGER
• DO NOT connect the device to an electrical supply without first verifying that the power supply is the
correct voltage. Incorrect voltage may cause device damage, malfunction, electrical shock, fire, or personal
injury. Your device was constructed to operate only on the electrical voltage specified on the Voltage
Rating and Serial Number Plate. Contact your DJO dealer if the device is not properly rated.
• Device is not designed to be used in oxygen rich environment, Explosion hazard if the device is used in the
presence of flammable anesthetic mixture with air, oxygen, or nitrous oxide.
• If the device is not safe for operation, it must be repaired by a certified service technician and the operators
must be informed of the dangers posed by the device.

17
UNPACKING THE DEVICE
The device is generally delivered with the packaging
material supplied by the manufacturer. As the device
weighs approximately  kg ( lbs), it must be
unpacked by at least  persons.
Proceed as follows:
• Position the transport packaging so that the
arrows are pointing upward.
• Remove the safety bands from the transport
packaging.
• Lift o the transport packaging upward.
• Remove the remaining foam material.
• Using at least  people, lift the device from
the lower packaging element.
• Inspect the device for any damages before
proceeding
Immediately upon unpacking the device, perform the
following steps:
. Verify the delivery documents to make sure that the
delivery is complete.
. Check the external components and accessories for
possible damage due to transport
. Verify that the packaging contains the following
• Intelect®RPW  device
• Intelect®RPW  Quick Start Guide
• USB Stick
• Pouch
• Gel Holder
• Cables Holder
• Power cord
• Conductor™Transmission Gel- ml (. oz)
bottle
• Standard Accessory Kit that Includes the
following:
» RPW Falcon Handpiece Applicator
» Projectile
» R  -  mm ESWT Transmitter
» D-S D-ACTOR® mm Transmitter
» Sealing Set
» Guide Tube
» Cleaning Brush
. Retain the original packaging. It may prove useful
for any equipment transport. Please refer to chapter to
page , the Accessories Section for information. For
information on optional accessories.
. A pouch is provided with the device. This pouch can
be attached onto the side of the device handle, useful
for accessories storage.
a. Position the pouch on the side of the device, just
below the handle rail:
b. Get the attachment textile part above the rail
c. Attach the textile part to the Velcro band located on
the back of the pouch

18
INTELECT®RPW 2 QUICK START GUIDE
. The Gel Holder cup can be attached on the any side
of the device
. The cable holder is used to hang the handpieces
cables
Throughout these instructions the terms “left”
and“right” referring to the machine sides are from the
perspective of a user standing in front of the device.
The components of the Intelect®RPW  are shown
below.

19
DEVICE DESCRIPTION
Handle
Color Touch Screen
Play / pause button
Falcon Hand Piece
Support
Transmitter Tray
Holder*
USB Connector
Rotary
adjusment Knob
V actor applicator
support
Switch
ON/OFF
Power Button
* Device delivered with 2 transmitters. Other transmitters displayed are optional.
* V-actor applicator is optional.

20
INTELECT®RPW 2 QUICK START GUIDE
FALCON HANDPIECE SETUP
. Unscrew the shaft from the handpiece and pull it out
of the handpiece handle. Use the supplied open-end
spanner for this purpose.
. Insert the new projectile into the fitted guiding tube
. Screw the shaft into the handpiece until
finger-tight. Using one hand, press the handpiece
firmly onto the table and tighten the shaft using the
open-end spanner. It must no longer be possible to
unscrew the shaft by hand.
. Screw the transmitter screw cap with the required
transmitter firmly back onto the shaft. For two-part
transmitter caps: Make sure that the two cap parts are
screwed firmly in place and that the transmitter screw
cap is screwed firmly to the shaft.
. Connect the Falcon handpiece to the right connector
on the device