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Intelect® RPW $ User Manual

The Intelect® RPW 2 User Manual provides comprehensive instructions on the operation, precautions, and maintenance of the Radial Pressure Wave device intended for licensed medical professionals. It outlines the device's intended use for therapeutic treatments, contraindications, and potential side effects, emphasizing the importance of following safety guidelines. The manual includes detailed sections on setup, user interface, treatment modes, and device specifications.

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0% found this document useful (0 votes)
19 views95 pages

Intelect® RPW $ User Manual

The Intelect® RPW 2 User Manual provides comprehensive instructions on the operation, precautions, and maintenance of the Radial Pressure Wave device intended for licensed medical professionals. It outlines the device's intended use for therapeutic treatments, contraindications, and potential side effects, emphasizing the importance of following safety guidelines. The manual includes detailed sections on setup, user interface, treatment modes, and device specifications.

Uploaded by

mhabo62
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 95

EN

Intelect® RPW 2
User Manual

Operator and Installation Instructions


INTELECT RADIAL PRESSURE WAVE 2 (RPW 2 )
REF 2 1 7 5 KIT (1 0 0 V)
REF 2 1 7 3 KIT (1 2 0 V)
REF 2 1 7 4 KIT (2 3 0 V)
2 CONTENTS EN

INTRODUCTION 5 GENERAL WARNINGS AND 14


PRECAUTIONS
FOREWORD 5

CAUTION 14
INTENDED USER PROFILE 5

WARNING 15
INTENDED ENVIRONMENT FOR USE 5

DANGER 16
INTENDED USE 5

PRECAUTIONARY INSTRUCTIONS 5
SETUP INSTRUCTIONS 17
HOME SCREEN DESCRIPTIONS 6
UNPACKING THE DEVICE 17
DESCRIPTION OF DEVICE MARKINGS 6
DEVICE DESCRIPTION 19
PAIN IN THE MUSCULOSKELETAL SYSTEM 8
FALCON HANDPIECE SET UP 20

POWERING UP THE DEVICE 21


INDICATIONS FOR USE 9

CONTRAINDICATIONS 9
SYSTEM 22
ADDITIONAL PRECAUTIONS 10
OPERATING DATA AND RATINGS 22
ADVERSE EFFECTS 10
FALCON HANDPIECE TECHNICAL SPECIFICATIONS 22
PATIENT APPLIED PARTS 10
SOFTWARE 22

TRANSPORT AND STORAGE CONDITIONS 22


DEVICE DESCIPTION 11

PRODUCT DESCRIPTION 11
PATIENT PREPARATION 23
COMPONENTS 12
TREATMENT TIPS 23
IFU DOWNLOAD 13

SYSTEM START-UP 13
USER INTERFACE 24
DEVICE CONNECTED TO THE MAINS 13
DEVICE USER INTERFACE 24

TO STOP TREATMENT 13
SCREEN DESCRIPTION 24

UNDERSTANDING YOUR BOTTOM BANNER 26

INTELECT® RPW 2 USER MANUAL


3 CONTENTS EN

CHANNEL STATUS POSSIBILITES 27 V-ACTOR HF HANDPIECE 66


OPERATIONS, SET-UP, CLEANING
BAR EXPLAINED 27
AND MAINTENANCE
COMFORT MODE EXPLAINED 28
DEVICE DESCRIPTION 66
SETTINGS 29
INSTALLATION INSTRUCTIONS 66
HOME SCREEN 30
UNPACKING 66
TREATMENT REVIEW SCREEN 31
SCOPE OF SUPPLY 66
GUIDELINES SCREEN 33
CONNECTING THE HANDPIECE 67
RADIAL PRESSURE WAVE OPERATION 33
OPERATION 68
SINGLE SHOT MODE 38
START-UP 68
SPS (SUGGESTED PARAMETER SETUP) 40
FUNCTIONAL CHECKS 68
TREATMENT DATA 43
STANDARD SETTINGS 68
CUSTOM PROTOCOLS 51
TREATMENT 70
SHORTCUTS 56
SAFETY INFORMATION 70
UNASSIGN SHORTCUT 58
CARRYING OUT TREATMENT 70
CLINICAL RESOURCES 59
CLEANING, MAINTENANCE, OVERHAUL 71
MODALITY DESCRIPTIONS 62
CHANGING THE SHOCK TRANSMITTERS 71
PRINT SCREEN FUNCTION 62 V25 AND V10

TROUBLE SHOOTING CODES 63 REPROCESSING THE HANDPIECE AND 71

SHOCK TRANSMITTERS

ACCESSORIES 64 HANDPIECE 72

REPLACEMENT ACCESSORIES 64 V25 AND V10 73

POWER CORDS 64 V40 73

OPTIONAL ACCESSORIES 65 TROUBLE-SHOOTING 74

ACCESSORIES AND SPARE PARTS 74

INTELECT® RPW 2 USER MANUAL


4 CONTENTS EN

TECHNICAL SPECIFICATIONS 74 SERVICE & WARRANTY 88

SYMBOLS AND LABELS 75 SERVICE LIFE 88

WARRANTY AND SERVICE 75 WARRANTY REPAIR/OUT OF WARRANTY REPAIR 88

WARRANTY 89

DEVICE MAINTENANCE 76

WATER RESERVOIR 76 APPENDIX 90

CLEANING THE INTELECT RPW 2 76 ELECTROMAGNETIC COMPATIBILITY (EMC) 90

COPY OF MANUAL 76

INSTRUCTION FOR SOFTWARE UPGRADE 76

DEVICE MAINTENANCE 76

FALCON HANDPIECE CLEANING, 77


MAINTENANCE; OVERHAUL

CLEANING 77

STANDARD SHOCK TRANSMITTERS 78

SPINE AND FASCIAE SHOCK TRANSMITTERS 79

CLEANING THE HANDPIECE 80

CLEANING THE SHOCK TRANSMITTERS 81

STANDARD SHOCK TRANSMITTERS 81

SPINE AND FASCIAE SHOCK TRANSMITTERS 82

CLUTCH FOR THE SPINE/FASCIAE SHOCK 82

TRANSMITTERS

OVERHAUL 83

OVERHAULING THE HANDPIECE 83

INTELECT® RPW 2 USER MANUAL


5 INTRODUCTION EN

FOREWORD INTENDED ENVIRONMENT FOR USE

This guide is intended for users of Intelect® RPW 2. The device is intended to be operated in a clinical
It contains general information on operation, precautionary environment, it can be moved from room to room.
practices, and maintenance. The device is not intended to be regularly transported from
Before administering any treatment to a patient, the one facility to another. It is not intended for home use.
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,
INTENDED USE
contraindications, warnings, and precautions. Consult The Intelect RPW 2 device is intended to be used as a
other resources for additional information regarding the therapeutic modality by clinicians needing to provide
application of Radial Pressure Wave and Vibration therapies. patients with a powerful and proven method of treating
indications as pain, myofascial trigger points, disorders of
tendon insertions, activation of muscle and connective
INTENDED USER PROFILE
tissue.
The intended user of this device is a licensed medical
professional trained to properly use the device: Individual results may vary. Neither DJO Global, Inc. nor any
Physical Therapist, Occupational Therapist, Athletic Trainers, of its subsidiaries dispense medical advice. The contents of
Chiropractors, Osteopaths, Orthotists, Podiatrists, Sport’s this document do not constitute medical, legal, or any other
Medicine Therapists and Medical Doctors. type of professional advice. Information related to various
The device shall not be sold OTC to non professional users health, medical, and fitness conditions and their treatment
is not meant to be a substitute for the advice provided by a
The user should be able to: physician or other medical professional.
• Read and understand the operator’s manual,
warnings, cautions and dangers.
PRECAUTIONARY INSTRUCTIONS
• Sense auditory and visual signals.
• Read and understand cautions and contraindications The precautionary instructions found in this section and
of the device throughout this manual are indicated by specific symbols.
• The operator shall operate only one device at a time Understand these symbols and their definitions before
and treat one patient at a time. operating this equipment. The definition of these symbols
• The device is not intended to be operated by the are as follows:
patient
CAUTION
Text with a “CAUTION” indicator explains possible safety
infractions that have potential to cause minor or moderate
injury or damage to the equipment.

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

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

INTELECT® RPW 2 USER MANUAL


6 INTRODUCTION EN

HOME SCREEN ICON DESCRIPTIONS DESCRIPTION OF DEVICE MARKINGS

Falcon Radial Pressure Waves Refer to Instructional Manual and


handpiece Quick Start Guide Booklet

Vibration Therapy handpiece V-Actor Warning, Caution, or Danger

Shortcut Electrical type B equipment

SPS (Suggested Parameter Setup) Play

Custom Protocols Pause

Treatment Data ON/OFF

Clinical Resources Manufacturer

Home Date of manufacture

Settings Catalogue number

USB Drive Serial number

Fragile, handle with care

This end up

Keep dry

Temperature Range

INTELECT® RPW 2 USER MANUAL


7 INTRODUCTION EN

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

Markings are conform to ISO7010 and ISO15-223-1"

INTELECT® RPW 2 USER MANUAL


8 INTRODUCTION EN

PAIN IN THE MUSCULOSKELETAL SYSTEM Tibial Edge Syndrome


Pain located along or just behind the medial edge of the
Before a treatment with Radial Pressure Wave, a correct tibia
examination and diagnosis should be performed.
Proximal Iliotibial band Friction Syndrome/Trochanteric
Please stay current with the latest developments and Insertion Tendonitis
medical publications on Radial Pressure Wave therapy for Pain or aching on the outer side of the knee or hip
details on contraindications and side effects 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 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.

INTELECT® RPW 2 USER MANUAL


9 INDICATIONS FOR USE EN

CONTRAINDICATIONS

The Intelect® RPW 2 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 6 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).

INTELECT® RPW 2 USER MANUAL


10 INDICATIONS FOR USE EN

ADDITIONAL PRECAUTIONS ADVERSE EFFECTS


When administering Radial Pressure Wave treatment, keep Side effects could occur after a treatment with Radial
in mind the following: Pressure Wave therapy. The majority will appear after 1-2
• Radial Pressure Wave treatment should be applied days. Do not repeat a treatment until the previous side
with caution over bone where minimal (bony effects have diminished. Common side effects include:
prominence) or no (Stage IV wounds) soft tissue is • Erythema, reddening
present. • Swelling
• Hearing aids should be removed. • Pain
• The function of other patient connected equipment • Hematoma
may be adversely affected by the operation of the • Petechiae, red spots
pulsed radial pressure wave equipment. Maintain • Skin lesions after previous cortisone therapy
maximum distance between devices in order to • These side effects generally abate after 5 to 10 days
reduce any tendency to interaction. Refer to the
EMC tables at the end of this manual for more
information. PATIENT APPLIED PARTS
• Any bleeding tendency is increased by heating
because of the increase in blood flow and vascularity Transmitters Material Applied part Type
of the heated tissues. Care, therefore, should be used A6 Steel 1.4021 Type B
in treating patients with therapeutic Radial Pressure
T10 Steel 1.4021 Type B
Wave treatment who have bleeding disorders.
• Frequent monitoring of intensity level and skin C15 Ceramic Volcera Type B

response should occur during all treatments. DI 15 Titan grade 5 ELI Type B
• Always apply the transmitter on the skin with small
F15 PTFE Type B
circular movements.
• Never use Radial Pressure Wave therapy on the head. D20-S Steel 1.4542 Type B

• Do not treat direct in an area with a metal implant. D35-S Steel 1.4542 Type B
• Patients with active autoimmune diseases may not
D20-T Titan grade 5 ELI Type B
respond positively with the treatment
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

Polyvinylidenfluorid EpoFlon –
SPINE ACTORS Type B
ECTFE (Halar)
Ultrasonic gel Water de-ionized water Gel (PH7) Type B

INTELECT® RPW 2 USER MANUAL


11 DEVICE DESCRIPTION EN

PRODUCT DESCRIPTION
The Intelect® RPW 2 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 effect on areas of the tissue
near the surface.
Note: This equipment is to be used only by a licensed medical
practitioner.

INTELECT® RPW 2 USER MANUAL


12 DEVICE DESCRIPTION EN

COMPONENTS
Gel Bottle
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 2 are shown below.

Falcon Handpiece

Gel for diagnostic and therapeutic medical procedures


should be water based with deionized water. No
formaldehyde, no fat. For external use only.

Pouch

Gel Holder

Cable Holders

INTELECT® RPW 2 USER MANUAL


13 DEVICE DESCRIPTION EN

IFU DOWNLOAD TO STOP TREATMENT


1. To download the IFU go to the Chattanooga website Press Play/Pause button to pause treatment then press Stop
www.chattanoogarehab.com on touch screen. If device is on mains power press the On/Off
2. Complete the registration to be informed of software and button on the front panel then turn off the switch on the back
IFU updates and register your device of the device.
3. Select your INTELECT RPW 2 model Trigger the handpiece or press Start/Pause button to pause
4. Click download IFU to start the download treatment then press Stop on touch screen. If device is on
5. A pdf viewer will be required to view IFU mains power turn of the switch on the back of the device.

SYSTEM START-UP
Complete the following steps for start-up of the Intelect®
RPW 2:

DEVICE CONNECTED TO THE MAINS


1. 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. Press and hold
for power off

2. Connect the Falcon handpiece on the right connector.

3. Turn on the power switch located on the back of the


device.

INTELECT® RPW 2 USER MANUAL


14 GENERAL WARNINGS AND PRECAUTIONS EN

CAUTION
• This device should be operated at 10°C to +40°C and 30% to 75% Relative Humidity (no condensation). The device should
be transported and stored at -20°C to +60°C and 10% to 90% Relative Humidity (no condensation).
• Atmospheric pressure requirements: 70 kPa to 106 kPa.
• The Falcon handpiece should be operated at 10°C to +40°C and 5% to 95% Relative Humidity (no condensation).
The handpiece should be transported and stored at 0°C to +60°C and 5% to 95% Relative Humidity (no condensation).
• The V-Actor HF handpiece should be operated at 10°C to +30°C and 5% to 95% Relative Humidity (no condensation). The
handpiece should be transported and stored at 0°C to +60°C and 5% to 55% Relative Humidity (no condensation).
• The time required for Intelect RPW 2 to warm from the minimum storage temperature between uses until Intelect RPW
2 is ready for its intended use when the ambient temperature is 20°C is 5 hours.
• The time required for Intelect RPW 2 to cool from the maximum storage temperature between uses until Intelect RPW 2
is ready for its Intended use when the ambient temperature is 20 °C is 5 hours
• Under single fault condition and extreme usage conditions, the maximum temperature of the hand piece can reach 47°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 2
System or that have been specified as being compatible with the Intelect RPW 2 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 offer the patient hearing protection.
• Apply a sufficient 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 300 shocks to the same spot during treatment.
• The surface of the transmitter can reach 47°C. Extended skin contact can cause minor burns. Interrupt therapy after a
maximum of 6000 pulses to allow the transmitter to cool.
• Operating the device at pressures higher than 3 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.
• 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 office via www.djoglobal.com for assistance and service information.
• Do not use while sleeping or operating heavy equipment.

INTELECT® RPW 2 USER MANUAL


15 GENERAL WARNINGS AND PRECAUTIONS EN

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 2 in water (Bath, Shower, etc.) that could cause electronic failure
• DO NOT operate the Intelect RPW 2 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 300 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 30 cm (12 inches) to any part of the Intelect RPW
2, 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 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
» Consult your authorized DJO dealer for help.
• No modification of this equipment is allowed
• The Intelect® RPW 2 may be susceptible to Electro-Static Discharge (ESD) at greater than ±8 kV when first grasping
either the Falcon or V actor hand piece. In the event of such a discharge, the Intelect® RPW 2 may experience
communication loss. The Intelect® RPW 2 will terminate all active outputs, automatically place the device in a safe state.
• To prevent Electro-Static Discharge (ESD) at greater than ±8 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 35% 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 35%.
» Communicate these ESD-precautionary procedures to healthcare staff, 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.

INTELECT® RPW 2 USER MANUAL


16 GENERAL WARNINGS AND PRECAUTIONS EN

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.

INTELECT® RPW 2 USER MANUAL


17 SETUP INSTRUCTIONS EN

UNPACKING THE DEVICE 4. Retain the original packaging. It may prove useful for any
equipment transport. Please refer to chapter to page 64,
The device is generally delivered with the packaging the Accessories Section for information. For information on
material supplied by the manufacturer. As the device weighs optional accessories.
approximately 32 kg (72 lbs), it must be unpacked by at least 5. A pouch is provided with the device. This pouch can
2 persons. be attached onto the side of the device handle, useful for
Proceed as follows: accessories storage.
• Position the transport packaging so that the arrows
are pointing upward.
• Remove the safety bands from the transport
packaging.
• Lift off the transport packaging upward.
• Remove the remaining foam material.
• Using at least 2 people, lift the device from the lower
packaging element.
• Inspect the device for any damages before
proceeding

a. Position the pouch on the side of the device, just below


Immediately upon unpacking the device, perform the the handle rail:
following steps: b. Get the attachment textile part above the rail
1. Verify the delivery documents to make sure that the c. Attach the textile part to the Velcro band located on the
delivery is complete. back of the pouch
2. Check the external components and accessories for
possible damage due to transport
3. Verify that the packaging contains the following
• Intelect® RPW 2 device
• Intelect® RPW 2 Quick Start Guide
• USB Stick
• Pouch
• Gel Holder
• Cables Holder
• Power cord
• Conductor™ Transmission Gel-250 ml (8.5 oz) bottle
• Standard Accessory Kit that Includes the following:
» RPW Falcon Handpiece Applicator
» Projectile
» R0 40 - 15 mm ESWT Transmitter
» D20-S D-ACTOR® 20 mm Transmitter
» Sealing Set
» Guide Tube
» Cleaning Brush

INTELECT® RPW 2 USER MANUAL


18 SETUP INSTRUCTIONS EN

6. The Gel Holder cup can be attached on the any side of the
device

7. 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 2 are shown below.

INTELECT® RPW 2 USER MANUAL


19 DEVICE DESCRIPTION EN

DEVICE DESCRIPTION

Handle

Color Touch Screen

Power Button

Play / pause button


V actor applicator
support

Rotary adjustment
Falcon Hand Piece Support
knob

Switch
ON/OFF USB Connector

Transmitter Tray Holder*

* Device delivered with 2 transmitters. Other transmitters displayed are optional.


* V-actor applicator is optional.

INTELECT® RPW 2 USER MANUAL


20 SETUP INSTRUCTIONS EN

FALCON HANDPIECE SET UP 3. Screw the shaft into the handpiece until finger-tight.
Using one hand, press the handpiece firmly onto the table
1. Unscrew the shaft from the handpiece and pull it out of and tighten the shaft using the open-end spanner. It must
the handpiece handle. Use the supplied open-end spanner no longer be possible to unscrew the shaft by hand.
for this purpose.

4. 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.

2. Insert the new projectile into the fitted guiding tube

5. Connect the Falcon handpiece to the right connector on


the device

INTELECT® RPW 2 USER MANUAL


21 SETUP INSTRUCTIONS EN

2. The first setup screen will be displayed after this


allowing the user to set language and time in the device.

3. If after this step you see the screen below, switch of


the device and follow instructions in point 4 below. If
POWERING UP THE DEVICE
you do not see this screen the device is ready to use.
Insert the power cord into the back of the device, insert the
plug into a power outlet. 4. Insert the supplied USB drive into USB port of device.
Switch device on with switch on the back of the device.
Make sure the mains connector remain accessible at all 5. Switch on the Intelect® RPW 2 device. The device will
times as it can serve as an emergency switch. Turn off the automatically detect software upgrade and install.
main rocker switch to completely switch off the device. For
an all-pole separation from the mains supply, disconnect
the mains plug from the socket.

1. The Initialisation screen below will be shown for a


few seconds whilst the device starts.

6. Home screen will be displayed when SW update is


finished.
Important: DO NOT interrupt the process. Do not connect any other
USB device or connection other than the USB key provided by DJO.
Electrical dysfunction and device damage could happen.

INTELECT® RPW 2 USER MANUAL


22 SYSTEM EN

OPERATING DATA AND RATINGS FALCON HANDPIECE TECHNICAL


Values displayed on the device are with a tolerance of ±10%
SPECIFICATIONS
Width.................................................................................................420 mm Compressed air input..........................................................1.0 - 5.0 bar
Depth .................................................................................................410 mm Ambient temperature during operation........................10 - 40 °C
Height .............................................................................................. 1140 mm Ambient temperature during storage..............................0 - 60 °C
Standard Weight (with one handset).......................32 Kg (72 lbs) and transport
Ambient temperature......................................................10 °C - 40 °C Ambient air pressure during operation..............800 - 1,060 hPa
Relative Humidity .................................................................30% to 75% Ambient air pressure during storage...................500 - 1,060 hPa
Air Pressure............................................................700 hPa to 1060 hPa and transport
Air humidity Storage...............................5 - 95%, non-condensing
Power Consumption and transport
350 VA (Model 2173DEV) Air operation...............................................5 - 95%, non-condensing
350 VA (Model 2174DEV) Weight....................................................................................................480 g
450 VA (Model 2175DEV)

SOFTWARE
Input
120V AC~ 50 - 60 Hz 350VA (Model 2173DEV) The software is developed and provided by DJO.
220-240V AC~ 50 Hz 350VA (Model 2174DEV) To view the version of the software, press the Settings
230V AC~ 60 Hz 350VA button. The version number of the Software can be found
100V AC~ 50 - 60Hz 450VA (Model 2175DEV) by pushing the display unit version information.

Output
0.3 - 5 bar 1 - 21 Hz (RPW) 1 - 50 Hz (V-Actor) (Model 2173DEV)
TRANSPORT AND STORAGE CONDITIONS
0.3 - 5 bar 1 - 21 Hz (RPW) 1 - 50 Hz (V-Actor) (Model 2174DEV) Ambient temperature..................................................-20 °C - 60 °C
0.3 - 5 bar 1 - 21 Hz (RPW) 1 - 50 Hz (V-Actor) (Model 2175DEV) Relative Humidity..............................10% - 90 % no condensation
Air Pressure...........................................................500 hPa to 1060 hPa
Mode ...................................................................... Single or Continuous
Compressed Air Output....................................................0.3 - 5.0 bar
Power Increment Settings...........................................................0.1 bar
Pulse Amplitude.................................approx. 2 mm at 3 bar, idling
(without coupling)
Pulse Width ..................................................................approx. 6 - 12 ms
Pulse Frequency.........1 - 21 Hz for RPW, 1 - 50 Hz for Vibration
Fuses......................................................... 2 x T6.3A H 250 V 5x20 mm
Electrical Class................................................................................CLASS I
Electrical Type (Degree of Protection)..................................TYPE B
Regulatory Risk Class..............IIa according to MDD 93/42/EEC
Mass........................................................................................29 Kg (64 lbs)
Safe Working Load.................................................................5 Kg (11 lbs)

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23 PATIENT PREPARATION EN

PATIENT PREPARATION
Before applying Radial Pressure Wave therapy to the
patient, first prepare the patient’s skin. By properly preparing
the patient’s skin for therapy, it allows more energy to reach
the targeted areas and reduces the risk of skin irritation.

To prepare the patient’s skin for therapy, do the following:


1. Thoroughly wash the skin on which intended treatment
is to be administered with mild soap and water or
alcohol wipe.
2. Dry the skin thoroughly.
3. Apply the ultrasound gel generously to the target area on
the patient
RPW treatment, given in the right dose and for the correct
indications, is an excellent treatment for many chronic
conditions that other treatment methods can’t improve or
heal. RPW therapy is very well perceived among
therapists thanks to its positive outcomes and its relatively
short treatment period.

TREATMENT TIPS
• Let your patient rest in a relaxing position during a
treatment session, providing them a rolled up towel
under their limb for comfort if needed during an
elevated treatment
• Localise the painful points you plan to treat. It might
be a good idea to mark up the points with a felt tip
pen.
• Apply a liberal amount of gel on the skin of the
treatment area.

Talk to your patient and ensure that they understand the


following:
• Treatment should start at minimal Bar level
• Bar level should increase slowly, manually or
automatically when using Comfort Mode
• Patient is responsible to let the clinician know at
anytime if treatment is becoming painful
Note: The therapist should pay attention to patient’s body’s reaction
to treatment

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24 USER INTERFACE EN

DEVICE USER INTERFACE

Intelect® RPW 2 ON/OFF button has several light indicators:


- steady ON from device connection to the mains
- Flashing while powering ON/OFF

PLAY/PAUSE button blue indicator: it flashes when user can start/resume a treatment. Otherwise, steady.

SCREEN DESCRIPTION

1. Menu Bar

2. Main Area

3. Channel Bar

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Each screen contains the following areas:

Menu Bar
Located at the top of each screen and lists the current screen name.

Current Screen
Go to Previous
Go to Home
Screen

Screen

Name
USB

Settings

Main area
Located under the menu bar, this area displays icons unique to the current screen.

1. Menu Bar

2. Main Area

3. Channel Bar

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UNDERSTANDING YOUR BOTTOM BANNER


The home screen will tell you if the handpiece(s) is connected (available = connected; unavailable = not connected). If the
handpiece is connected but the device detects an error, a message might be displayed, please see page 64 for details.
The left side of the screen will tell you what transmitter you have selected with an image of the transmitter - ensure you have
the proper transmitter on the end of the handpiece.
The right side will tell you pulse count, treatment status, handpiece selected (therapy). The treatment status will change as the
treatment progresses in generally the following order: Set-up, Arm, Armed, Running, Pause, Completed.

V Actor status:
Falcon status:
Available
Available

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CHANNEL STATUS POSSIBILITIES:

Indicates the
Indicates that handpiece is
handpiece is
not available for use
available for use

Indicates that
Indicates that transmitter
transmitter type has
type is selected
not been selected

Indicates
Indicates treatment is
compressor is
running
armed

Indicates that the handpiece


Indicates
is not working properly
treatment is
or not compatible with
paused
INTELECT® RPW 2

Indicates
treatment is
completed

BAR EXPLAINED
Bar is the unit of measure for the intensity applied by the handpiece and felt by the patient.
Bar settings can be increased or decreased by using the turning dial on the device.
Bar measurements start at 0.3 and can reach 5.0; Bar will increase in 0.1 increments.
Lower settings, such as <1.0 Bar should be reserved for Spinal and Facial treatments unless the patient has a low pain threshold.
Higher Bar settings above 1.4 should be used for all other treatments.

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COMFORT MODE EXPLAINED


In the legacy Intelect® RPW this feature was called Ramp Mode. This same user friendly functionality has been applied to the
Intelect RPW 2.
BAR

3 BAR
NO RAMP

RAMP ON

RAMP ON
BUT STOP

TREATMENT
2000 PULSES

The Comfort Mode feature turns the ramping function on and off. This feature slowly increases the Bar and allows the patient to
get used to the pressure of the output instead of administering the full output all at once. This feature defaults to ‘ON’, it allows
the device to gradually increase the Bar or intensity to the desired treatment Bar setting. The device will increase to the desired
Bar setting starting at 1/10 of the desired Bar, slowly increasing in increments of 1/3 of the set amount of pulses until it reaches
full Bar strength.
By touching the screen this feature can be turned ‘OFF’.
Note: If the Comfort Mode has been turned ‘OFF’ before the treatment, it cannot be enabled in the middle of a treatment; while a treatment session
is in progress.

During the treatment, while the device is in the process of ramping up to the treatment Bar level, the device can be paused.
When resuming the treatment from being paused the treatment can progress in one of three ways:
1. Continue to ramp to the full treatment Bar
2. The treatment can resume at Bar level when paused during ramp up
3. The treatment can be resumed and the clinician can turn the dial on the device so that the ramp is on a lower setting for the
remainder of the treatment.

The Bar adjustment is the most sensitive parameter to be set and is very important to set correctly.
A low level of Bar energy would not be efficient, as 50% of the energy is lost at the skin’s surface. While a high level of energy
could generate intense pain during the treatment causing the patient to not seek further therapies. The Intelect RPW 2 comfort
mode is designed to help the clinician determine what level of Bar energy and discomfort the patient can accept.

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29 USER INTERFACE EN

SETTINGS
The settings icon on the home screen menu bar (see first page of User Interface section) offers users the opportunity to set
preferences:
1. Home screen name: on the home screen, the "current screen name" displayed in the middle portion of the menu bar is by
default ‘Home’. This can be changed into a name of your choice, e.g. the clinic name. If you want to change, select the Device
name, use the displayed keyboard to enter a new name and confirm. The clinic name displays on the Home Screen and on the
patient treatment reports
2. Language: Touch this box if you want to choose another language
3. Device name: Select the Device name, use the displayed keyboard to enter a new name and confirm. The device name
displays on the Home Screen and on the patient treatment reports
4. Date & Time: Select the Date and Time box to set the date and time on the device.
5. Screens and sounds
Brightness: Select the Brightness icon to set the brightness of the LCD screen. The brightness ranges from 50% (dimmest) to
100% (brightest) in 10% increments. The default setting is 80%.
Sound Volume: select the Volume box to set desired audio volume. The volume range is 0% (of to 100% (loudest) and is
measured in 20% increments. The default setting is 40%
Keypads sounds Default is On
6. Pulse counter RPW can be reset
7. Display Device Version Information
8. Reset default treatments
9. Reset to factory default
10. Servicing/Maintenance
11. Restore Default Device Settings
12. Restore Default Protocols

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HOME SCREEN
The Intelect® RPW 2 Home screen provides access to all of the system modalities and functions. The Home screen has the
following information:

Modalities Assign or launch Shortcut Libraries

« Suggested Parameter Setup »


Pre-programmed protocol library

Clinician protocol library

Educational library:
· Modality descriptions
· Anatomical images
· Pathological images

Treatment data storage

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TREATMENT REVIEW SCREEN


By selecting Radial Pressure Wave, Vibration Therapy, or the screen will automatically change to the ‘treatment review screen.
The Intelect® RPW 2 Treatment Review screens include the following information:

Parameters

Swipe vertically to see


Save/Overwrite more parameters
default settings or
Custom Protocols 1. Touch to activate
Active box surrounded
Treatment
by black line
guidelines
2. Adjust with
Assign treatment Adjustment dial:
• Clockwise – Increase
Select • Counterclockwise –
Transmitter Decrease
Note: When a
parameter is not
adjustable, the
parameter box is faded.

Select transmitter sub menu screen

Select transmitter type

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Select transmitter

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GUIDELINES SCREEN
The Guidelines provide the following information:
Modality description, terms, indications and contraindications, treatment guidelines

Touch image to view


in full screen mode

Swipe horizontally
for more

RADIAL PRESSURE WAVE OPERATION


Complete the following steps to begin treatment:
1. Prepare patient for Radial Pressure Wave treatment. Refer to the PATIENT PREPARATION section
2. Select Falcon handpiece icon from the home screen

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3. SET UP TREATMENT
On the treatment review screen - you can adjust treatment parameters to desired level.
Note: Never start with pressure adjustment – first adjust all other parameters and set Bar just before starting treatment

Parameters

1. Touch to activate
2. Adjust with Adjustment dial:
• Clockwise – Increase
• Counterclockwise – Decrease

4. TRANSMITTER SELECTION
Once selecting the “transmitter type” button (as shown previously), a screen showing four types of transmitter options will
be displayed. The second screen will show a listing of the transmitters available for that particular type of transmitter option.
Touch the transmitter you wish to use. Once selected, the information will be populated into the treatment screen with the
transmitter of choice.

selection indicates the Transmitter


type box

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5. START TREATMENT WITH COMFORT MODE "ON"


Press the start/pause button

The compressor is arming for a few second then when the message "armed" is displayed, the treatment can start by triggering
the handpiece.
The button on the top of the handpiece is the trigger button, also called the start/stop button.

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6. TREATMENT RUNNING
When the treatment starts with Comfort mode "ON" the bar will increase progressively starting at 1/10 of the set value.
The actual value is displayed on the Comfort mode progression bar.
When the patient states that the treatment feels uncomfortable or painful, the therapist pauses the treatment by triggering the
handpiece.
The therapist has 2 options :
1. Resume treatment at Comfort mode level.
2. Continue Comfort level search by resuming treatment.

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7. PAUSE TREATMENT
Pausing treatment will automatically display stop treatment on the Treatment Review screen.

The treatment can be paused by pressing the PAUSE buttons located on the device. The treatment can also be paused by
pressing the button located on the handpiece.

Please reference the example scenarios:

Scenario 1: handpiece is active and projectile is moving. The handpiece button is pressed, projectile stops moving but the
handpiece remains active. The button on the handpiece is pressed again, the projectile resumes movement, and treatment can
resume.

Scenario 2: handpiece is active and projectile is moving. The device pause button is pressed, projectile stops moving but the
handpiece remains active. The handpiece button is pressed, but nothing happens. The device pause button is pressed again
and this lets the handpiece know the device is ready to start the treatment. Now if the handpiece button is pressed again the
projectile resumes movement and treatment can resume.

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8. STOP TREATMENT
If handpiece is active and projectile is moving:
Pause the treatment first, then the handpiece becomes inactive. Then by selecting Stop treatment, the treatment will end and
treatment summery displayed.

9. SINGLE SHOT MODE


The Falcon D-Actor has the ability to do single shots.

This can be done by selecting Frequency and turning the dial to the left so that the Hz is displayed as “—“. Then select Pulses and
change the pulse count to '1'.

When this single shot treatment is complete the Treatment summery screen will be displayed.

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10. TREATMENT SUMMARY


When treatment has completed, the Treatment Summary screen will appear with the following options:
• Repeat the treatment by pressing the Run again box.
• Save
» therapy information to Treatment Data
» the treatment protocol to the Custom Protocols
• Exit Modality and return to home screen

Settings of completed treatment

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SPS (SUGGESTED PARAMETER SETUP)


The Intelect® RPW 2 has a Suggested Parameter Setup (SPS) icon that is a series of protocol presets where the body area, clinical
indication, pathological condition and severity are selected by the user, and the suggested algorithm will select the parameter
settings. All settings can be edited to suit appropriate patient treatment prescription and patient comfort.

COMPLETE THE FOLLOWING STEPS TO START AN SPS PROTOCOL:

1. Select SPS from the Home Screen

2. Touch the BODY PART you wish to treat


Note: the selected body part will be highlighted and moving your finger to another area while holding screen contact will highlight and select
another body part.

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41 USER INTERFACE EN

3. Select INDICATION

Select Pressure Wave

4. Select INDICATION

Select Pain Zone treatment

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42 USER INTERFACE EN

5. SELECT MODALITY

Select Radial Pressure Wave

6. SET UP TREATMENT
On the treatment review screen the suggested treatment settings are displayed and you can adjust parameters to desired level.

Parameters

1. Touch to activate
2. Adjust with Adjustment dial:
• Clockwise – Increase
• Counterclockwise – Decrease

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43 USER INTERFACE EN

7. START TREATMENT
Press the START button

Treatment Running

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TREATMENT DATA
After a treatment has been completed, Treatment data can be saved on the Intelect® RPW 2 for later use on the device.

SAVE TREATMENT DATA

1. Touch ASSIGN TO on the Treatment Summary screen

2. Select ASSIGN TO to save Treatment Data

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45 USER INTERFACE EN

3. The TREATMENT DATA screen appears


Save treatment data by selecting ADD

Create & save


to new ID

Select & save


to existing ID

SAVE TREATMENT DATA TO A NEW ID:

Enter ID and Save

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46 USER INTERFACE EN

VIEW AND MANAGE TREATMENT DATA

Press the TREATMENT DATA ICON on the home screen

1. VIEW Treatment Data


Select Treatment Data

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47 USER INTERFACE EN

The TREATMENT HISTORY is displayed including all previously saved treatment sessions ranked chronologically

Select session to view Treatment


Summary for that session.

Session details are displayed

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48 USER INTERFACE EN

2. DELETE Treatment Data


Delete all IDs

Delete one ID

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49 USER INTERFACE EN

Confirm or cancel

Delete all treatment sessions

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50 USER INTERFACE EN

Delete one session

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51 USER INTERFACE EN

CUSTOM PROTOCOLS
The Intelect® RPW 2 allows for a maximum of 25 custom protocols to be defined.

SAVE A CUSTOMIZED PROTOCOL


A new custom protocol may be saved at either the Treatment Review or Treatment Summary screen.

1. Touch SAVE on the TREATMENT REVIEW or TREATMENT SUMMARY screen

2. Select SAVE TO CUSTOM PROTOCOLS

Note: it is also possible the overwrite the default settings of the modality instead of saving to custom protocols.

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52 USER INTERFACE EN

3. The Custom Protocol library is displayed where you can save the protocol as NEW custom protocol or OVERWRITE an
existing custom protocol

Create new
custom protocol

Select and overwrite


existing protocol

Alphabetical list
Swipe to see more

CREATE NEW CUSTOM PROTOCOL:

Enter Custom Protocol Name and Save

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53 USER INTERFACE EN

VIEW AND MANAGE CUSTOM PROTOCOLS

Touch the CUSTOM PROTOCOLS icon on the Home Screen

1. VIEW Custom Protocol


Select desired Custom Protocol

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54 USER INTERFACE EN

The TREATMENT REVIEW SCREEN is displayed showing the protocol settings.


Start treatment or perform other actions.

2. DELETE custom protocol


Delete all protocols

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55 USER INTERFACE EN

Delete one protocol

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SHORT CUTS
Intelect® RPW 2 allows for 12 custom protocol shortcut assignments on the home screen.

ASSIGN SHORTCUT
Complete the following steps to assign a home screen shortcut unassigned. Short cut icons appear grey in color for a
customized protocol: Press one of the unassigned “Shortcut” icons on the home screen .

Select the desired protocol in the Custom Protocol library

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57 USER INTERFACE EN

Shortcut assigned on home screen

Once assigned the shortcut icon becomes the color associated with the modality it contains

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58 USER INTERFACE EN

UNASSIGN SHORT CUT


Complete the following steps to unassign a Home screen shortcut for a customized protocol:
From the Home screen, press and hold the shortcut icon you wish to unassign.

The device will display a text box asking, “Remove “My Custom Protocol 1” shortcut?”

Select “No” to quit the unassignment process and return to the Home screen or “Yes” to continue with the unassignment
process.
After selecting “Yes” the previously assigned shortcut will no longer appear on the Home screen.

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CLINICAL RESOURCES
The Intelect® RPW 2 contains a unique Clinical Resources Library.
The anatomical and pathological image library are designed to aid the operator in visually understanding and locating specific
muscle groups and commonly found problems associated with pathological conditions, as well as providing an educational tool
for the clinician to use with the patient.
The modality descriptions provide information about the physical background and physiological effects of the Radial Pressure
Wave and Vibration therapy, aiming to assist the user in selecting the appropriate modality.
Complete the following steps to view the Clinical Resources Library:

Press the Clinical Resources Library icon on the Home screen .

ANATOMICAL/PATHOLOGICAL IMAGE LIBRARY


Complete the following steps to view the Anatomical or Pathological Image Library:
1. Press the Anatomical or Pathological Image Library icon on the Clinical Resources screen

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60 USER INTERFACE EN

2. Touch the body part for which you wish to view information.
Choose either anterior (on left of screen) or posterior (on right of screen).

3. The available images for the selected body part are displayed.
Touch the image you want to see in full screen mode.

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61 USER INTERFACE EN

4. Full screen image

Close full screen mode

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MODALITY DESCRIPTIONS
Complete the following steps to view the Radial Pressure Wave and Vibration therapy descriptions:
1. Select one of the modality description

2. The modality description is displayed

PRINT SCREEN FUNCTION


The Intelect® RPW 2 device has a built in function allowing the user to print screen for example to print a treatment session this
performed by:

1. Insert USB drive into the USB port on the back of the Intelect® RPW 2 device
2. Press the play pause button and the On/Off button simultaneously for around 1 second the screen will flash and the image is
captured on the USB drive.
3. In the setting menu eject the USB drive to enable safe removal from the Intelect RPW 2 device.
4. The format of the file is a bitmap file and it is date & time coded in the file name.
Note : The print screen function should not be used during treatment

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63 TROUBLESHOOTING EN

TROUBLESHOOTING CODES
1. All system messages, warning messages and fault messages that are generated by the device are self-explanatory excepting
system error.
2. If System error occurs, note error code and contact DJO selling dealer or DJO Service Department
3. In case a red triangle is shown, click on the triangle to get an explanation

[email protected]

If the device is not powering on, display and lights do not switch on
1. Check that ON/OFF button on the rear of the device is ON
2. Check the power cable is connected to proper alimentation

INTELECT® RPW 2 USER MANUAL


64 ACCESSORIES EN

ACCESSORIES

REPLACEMENT ACCESSORIES

The following tables provide users of the Intelect® RPW 2 the necessary information to order replacement accessories used
with the system. This list of replacement accessories is designed for use with the Intelect® RPW 2 . When ordering, provide
the respective part number, description, and quantity desired. All part numbers listed below are sold in quantities of 1 unless
otherwise specified.

Model Number Description

18080 Falcon® RPW Handpiece

28178 Ro40 'Beam' Transmitter

29724 D20-S D-Actor® 20mm Transmitter

29104 Revision Kit Short

15-1140 USB Key

22651 Gel cup and holder

82-0274 RPW Pouch

22652 Transmitter tray

13-7611-1 Cable holder

22654 Water reservoir

13-28660* Quick Start Guide (Available in multiple languages with each unit)

POWER CORDS
Model Number Description

14679 Power cord North American

14814 Power cord Switzerland

40-0108 Power cord UK

14816 Power cord India

14817 Power cord Israel

14818 Power cord Denmark

14819 Power cord Austrailia

14820 Power cord EU

14821 Power cord Japan

40-1112 Power cord Argentina

Note: For Falcon handpiece replacement accessories please see page 73

Falcon and D-Actor are registered trade marks of Storz medical AG

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65 ACCESSORIES EN

OPTIONAL ACCESSORIES
Model Number Description

29104 Revision Kit Short

28739 Guiding tube cleaning brush

31800 9 Transmitter Set In Case, Accessory

29801 A6 Point, Transmitter

29802 T10 Finger, Transmitter

29729 C15, 15 mm Cerama-X Transmitter, Black

29728 DI15, 15 mm, Deep Impact Transmitter, Black

29726 F15 Focus-Lens 15 mm Transmitter

29724 D20-S D-Actor® 20mm Transmitter

28736 D20-T Transmitter

29725 D35-S, 35 mm, D-Actor® Transmitter, Black

29539 ATLAS Transmitter

28946 INTELECT RPW 2 SPINE-ACTOR Transmitter set

28945 INTELECT RPW 2 PERI-ACTOR Transmitter set

19365 V-Actor® HF

28740 V-Actor® V25 Transmitter

28741 V-Actor® V40 Transmitter

29742 V-Actor V10 Transmitter without transmitter screw cap

4248 CONDUCTOR US Gel 24x 8.5oz BOTTLES

4238 CONDUCTOR US Gel 5L Cube w/ refillable bottle

4266 Intelect US Gel 5L Cube w/ refillable bottle

82-0274 RPW Pouch

15-1140 USB Key

18638 R15, 15 mm, ESWT transmitter, black

Falcon, D-Actor® and V-Actor® are registered trade marks of Storz medical AG

INTELECT® RPW 2 USER MANUAL


66 V-ACTOR HF HANDPIECE OPERATIONS, SET-UP, CLEANING, AND MAINTENANCE EN

V-ACTOR HF® HANDPIECE OPERATIONS, SET-UP, CLEANING, AND


MAINTENANCE

DEVICE DESCRIPTION INSTALLATION INSTRUCTIONS


The V-ACTOR HF® is a “vibration therapy” handpiece
and can be used as an optional accessory with the
Intelect® RPW 2. UNPACKING
• Remove the handpiece and accessories from the
By using this handpiece, it is possible to treat soft tissues packaging container.
using high-frequency pulses. • Check that all items are included in the packaging
container and that they are not damaged.
• Contact your supplier or the manufacturer immediately if
1: Trigger button any items are missing or damaged.

SCOPE OF SUPPLY
The standard scope of supply of the V-ACTOR HF handpiece
2: Shock transmitter includes the following items:
– Handpiece
– Vibration transmitter V25 with screw cap
– Vibration transmitter V40 with screw cap
The preconditions for using the V-ACTOR HF handpiece
correspond to the preconditions for operating the
Note: The V10 vibration transmitter is an optional accessory for the
Intelect RPW 2. Please read the Contraindications V-Actor HF and must be ordered separately.
chapter in this IFU for more details.

*V-Actor is a registered trade mark of Storz medical AG


Depending on the therapy to be performed, the
handpiece can be equipped with one of the following
three shock transmitter heads:

1: V-ACTOR HF spherical vibration transmitter 10 mm


(V10)
2: V-ACTOR HF vibration transmitter 25 mm (V25)
3: V-ACTOR HF vibrationtransmitter 40 mm

1 2 3

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67 V-ACTOR HF HANDPIECE OPERATIONS, SET-UP, CLEANING, AND MAINTENANCE EN

CONNECTING THE HANDPIECE


The Intelect® RPW 2 has a connector for the V-ACTOR HF®
handpiece and a designated handpiece holder on the left
hand side of the device.

To connect your V-Actor HF, please find the connectors on the


front of the device. As the handpiece holder for the V-Actor is
on the left hand side of the device it is recommended that the
connector plug on the left side is used.

• Insert the plug of the handpiece into the handpiece


connector on the Intelect RPW 2.
• Make sure that the red dot on the plug is aligned with the
red dot on the handpiece connector.
• Gently pushing the plug into the connector will
immediately lock the access and will prevent the
connector from disengaging automatically when the cable
is pulled.
• Place the handpiece into the handpiece holder.
• To break the connection, pull the outside of the plug body.
This first releases the locking function, allowing the plug to
be pulled out of the handpiece connector.

1: Red dots

2: Outside of
plug body

*V-Actor is a registered trade mark of Storz medical AG

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68 V-ACTOR HF HANDPIECE OPERATIONS, SET-UP, CLEANING, AND MAINTENANCE EN

OPERATION
The handpiece is operated via the display on the Intelect® RPW 2. The settings can either be made manually on the display or
preprogrammed settings can be applied.

At t ent i on!
Malfunction of the device or its components is possible!
Before starting treatment, it is essential to perform the FUNCTIONAL CHECKS described below.

START-UP
• Connect the V-ACTOR HF® handpiece to the Intelect RPW 2.
• Set the pulse energy in V-ACTOR HF operating mode to an initial value of 2 bar.
• Activate the trigger button.
Note: The trigger button functions as an on/off switch when it is pressed briefly. Pressing it for longer causes it to function as a tip switch, i.e. the
pulses will continue until the button is released.

FUNCTIONAL CHECKS
Perform the following functional checks after the device has been installed:
• Set the energy level in V-ACTOR HF mode to 2.4 bar.
• Reset the actual number of pulses on the display of the control panel.
• Release pulses with a pulse frequency of 30 Hz.
• Check that the triggered pulses are correctly counted on the treatment pulse counter of the control device.

STANDARD SETTINGS
• Before each treatment, make sure that the pulse counter is set to zero.
• Start the V-ACTOR HF treatment at an energy level of 2 bar and a frequency of 20 Hz.
• There is a relationship between pressure and frequency; when one increases the other decreases. The V-Actor HF can not be
used at full frequency and full pressure at the same time. Please find the chart showing the relationship between pressure and
frequency on page 70.

*V-Actor is a registered trade mark of Storz medical AG

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69 V-ACTOR HF HANDPIECE OPERATIONS, SET-UP, CLEANING, AND MAINTENANCE EN

The chart shown here displays the relationship between


pressure and frequency when using the V-Actor HF with the
Intelect® RPW 2.

Pressure (Bar) Frequency (Hz)

2.4 50

2.5 46

2.6 42

2.7 41

2.8 39

2.9 38

3.0 36

3.1 35

3.2 34

3.3 33

3.4 31

3.5 30

3.6 28

3.7 27

3.8 26

3.9 25

4.0 24

4.1 23

4.2 22

4.3 21

4.5 20

4.6 19

4.8 18

5.0 17

INTELECT® RPW 2 USER MANUAL


70 V-ACTOR HF HANDPIECE OPERATIONS, SET-UP, CLEANING, AND MAINTENANCE EN

TREATMENT

SAFETY INFORMATION
Before using the device, the user must make sure it is functioning safely and in proper condition.
Each time the device is transported, subsequently make sure that all functional checks have been performed on the device
before you start treatment. For further information, reference page 69, FUNCTIONAL CHECKS.

Note: The maximum energy level used during treatment must not cause the patient undue pain under any circumstances.

Caut i on!
The handpiece may not be operated while idling (without an impact surface).
• Do not trigger pulses unless the vibration transmitter is in contact with the treatment zone!

Caut i on!
Over extended periods, the noise of the pulses may be perceived as unpleasant!
• Offer ear protection to the patient.
• Recommendation: The user should also wear ear protection.

CARRYING OUT TREATMENT


• Apply a sufficient amount of massage oil to the patient's skin in the treatment area and to the V-ACTOR HF vibration
transmitter.
• Perform V-ACTOR HF treatment as recommended in the application brochure/application recommendations.

*V-Actor is a registered trade mark of Storz medical AG

INTELECT® RPW 2 USER MANUAL


71 V-ACTOR HF HANDPIECE OPERATIONS, SET-UP, CLEANING, AND MAINTENANCE EN

CLEANING, MAINTENANCE, OVERHAUL • To remove the V40 vibration transmitter, unscrew the
vibration transmitter from the handpiece.
• Unscrew the vibration transmitter screw cap (1 and 5) and
pull out the shock transmitter.
CHANGING THE VIBRATION
• Remove the sealing ring (3) by pressing it apart at the
TRANSMITTERS V25 AND V10 cut-through point (6).

• To remove the 25 mm vibration transmitter or the 10 mm • To clean, press the spring element (4) together slightly

spherical vibration transmitter, unscrew the vibration and remove the residue underneath it. Do not attempt to

transmitter screw cap (1) from the handpiece and pull out remove this portion of the transmitter!

the vibration transmitter (2). • Clean all parts of the vibration transmitter as described on

• Clean all parts of the vibration transmitter as described on page 73 and allow to air dry. When reassembling the V40,

page 73. note that the sealing ring has a lower lip (7) that needs to

• Allow vibration transmitter to air dry face outward when reassembled.

• Reassemble the vibration transmitter in reverse order.


• Screw the new vibration transmitter onto the handpiece
until finger-tight.

2
1

• Reassemble the vibration transmitter in reverse order.


• Make sure that the smooth side of the sealing ring (3) is in
contact with the vibration transmitter head (2).
• Screw the new vibration transmitter onto the handpiece
V40 until finger-tight.

1 2 4 3 5
*V-Actor is a registered trade mark of Storz medical AG

7
6

1 Front cap
2 Vibration transmitter head
3 Sealing ring
4 Spring element
5 Rear cap
6 Cut
7 Lower lip

INTELECT® RPW 2 USER MANUAL


72 V-ACTOR HF HANDPIECE OPERATIONS, SET-UP, CLEANING, AND MAINTENANCE EN

HANDPIECE

Caut i on!
Cleaning agents and disinfectants may generate an explosive atmosphere.
Disconnect the handpiece from the control device before starting any cleaning or maintenance work.

At t ent i on!
It is essential that no fluid be permitted to penetrate either the device or its tubing.

• Clean the coupling gel off the handpiece using a cleaning agent that is suitable for surface cleaning.
• Disinfect the handpiece with an alcohol-based disinfectant that is suitable for surface cleaning (follow the manufacturer's
instructions).
• Clean the vibration transmitters thoroughly after each use.
• The vibration transmitters can be cleaned using the usual cleaning agents and disinfectants after each use.
• As an alternative, you may clean the vibration transmitters each day in an ultrasonic bath.

At t ent i on!
The constituents listed here are non-binding examples. No claims are made regarding the
completeness of the list.

INTELECT® RPW 2 USER MANUAL


73 V-ACTOR HF HANDPIECE OPERATIONS, SET-UP, CLEANING, AND MAINTENANCE EN

REPROCESSING THE HANDPIECE AND


VIBRATION TRANSMITTERS
After each use, the parts of the handpiece that come into
contact with the patient must be cleaned and disinfected
thoroughly before they are used again.

The instructions must be strictly observed in order to


prevent damage to the parts and malfunctions.

Make sure that you have the following agents and


equipment available to perform the cleaning and V40
disinfection work:
• Unscrew the vibration transmitter from the handpiece.
– Clean, soft and lint-free cleaning cloths
• Disassemble the threaded two-part shock transmitter
– Cleaning agent
screw cap.
– Alcohol-based surface disinfectant
• Remove the vibration transmitter insert from the front cap.
– Ultrasonic bath (if desired)
• Remove the front sealing ring (2).
• This is cut open so that it can be removed more readily.
• The spring element on the vibration transmitter insert (1)
V25 AND V10
does not need to be removed.
• Unscrew the vibration transmitter from the handpiece. • Clean all of the parts under running water.
• Remove the vibration transmitter insert from the front cap. • Alternatively, you can clean and disinfect the vibration
– The spring element (1) on the vibration transmitter insert transmitter insert and the sealing ring in an ultrasonic
does not need to be removed. bath.
• Clean all of the parts under running water.
• Alternatively, you can clean and disinfect the vibration
transmitter insert and the sealing ring in an ultrasonic 1 2

bath.

INTELECT® RPW 2 USER MANUAL


74 V-ACTOR HF HANDPIECE OPERATIONS, SET-UP, CLEANING, AND MAINTENANCE EN

TROUBLE-SHOOTING
Fault description Possible cause Corrective actions
Check the cable and tube connections and replace them, if
No compressed air supply Leaks in handpiece cable or cable not properly connected
necessary

No power output Handpiece defective Replace the handpiece

ACCESSORIES AND SPARE PARTS

Accessories Art. no.:

V-ACTOR HF® handpiece set 19365

25 mm vibration transmitter 28740

40 mm vibration transmitter 28741

10 mm spherical vibration transmitter without vibration transmitter screw cap 29742

TECHNICAL SPECIFICATIONS

V-ACTOR handpiece

V-ACTOR operating frequency 1 – 50 HZ

Energy selection in steps from 1 – 5 bar

Ambient temperature during operation 10 °C – 30 °C

Ambient temperature during storage and transport 0 °C – 60 °C

Ambient air pressure during operation 800 – 1060 HPA

Ambient air pressure during storage and transport 500 – 1060 HPA

Air humidity during operation 5 – 55%, non-condensing

Air humidity during storage and transport 5 – 95%, non-condensing

Weight incl. cable, filled approx. 400 G

Protection against ingress of water IPX0

Subject to technical changes


Note: In the event of the medical product being transferred to third parties, the following must be observed:

– The complete device documentation must be delivered together with the medical product.

– The medical product may only be exported to a foreign country if the medical product and the corresponding indications are allowed there.

This device complies with the applicable standards.


For information about conformity with directives, please refer to the separate operating manual for your control device.

*V-Actor is a registered trade mark of Storz medical AG

INTELECT® RPW 2 USER MANUAL


75 V-ACTOR HF HANDPIECE OPERATIONS, SET-UP, CLEANING, AND MAINTENANCE EN

SYMBOLS AND LABELS

Label Meaning

You must read the operating manual!

WARRANTY AND SERVICE

WARRANTY FOR THE V-ACTOR® HF HANDPIECE


The V-ACTOR HF® handpiece is a wear part. We will replace new handpieces that have performed up to 1 million pulses at
no charge to the customer upon the customer furnishing adequate proof that the defect is due to defects in material or
workmanship of the handpiece.

Transport costs and the risk of loss during the shipping of returned products shall be borne by the customer.
Warranty claims will only be accepted if the handpiece is returned in its complete and original state, cleaned and in the case,
with the repair label filled in completely.

Missing components will be replaced subject to charge. Accessories also sent will be checked and, if necessary, replaced after we
have assessed them.

Vibration transmitters and overhaul kits are not covered by the handpiece's warranty.

At t ent i on!
Modifications to the handpiece and the transmitters are not permitted. Any unauthorised opening, repair
or modification of the handpieces by unauthorised personnel will relieve the manufacturer of its liability and
responsibility for safe system operation. This will automatically void the warranty even before the end of the
warranty period.

SERVICE
Should you have any further questions or require additional information, please feel free to contact your dealer.
See page 88 in this manual for details.

*V-Actor is a registered trade mark of Storz medical AG

INTELECT® RPW 2 USER MANUAL


76 DEVICE MAINTENANCE EN

DEVICE MAINTENANCE CLEANING THE INTELECT® RPW 2


With the system disconnected from the power source, clean
WATER RESERVOIR the system with a clean, lint-free cloth moistened with water
and mild antibacterial soap. Do not use solvents. If a more
The RPW 2 uses a condenser between the compressor
sterile cleaning is needed, use a cloth moistened with an
and the handpiece to extract air humidity to avoid water
antimicrobial cleaner. Cleaning should be performed daily.
accumulation in the hand piece. The extracted water is
Do not submerse the system in liquids. Should the device
collected in the water reservoir located on the back panel
accidentally become submersed, contact the dealer or DJO
just below the power cord port.
Service Department immediately. Do not attempt to use a
The water level should be checked every day before use. The
system that has been wet inside until inspected and tested by
water reservoir should be emptied on a regular basis.
a Trained Technician.

To empty the reservoir follow the instructions. Cleaning the LCD Screen
1. Press the release clip and gently lift-up the water reservoir Clean the LCD with a clean, dry cloth, in the same way as
from the Intelect RPW 2, sliding it up.
®
cleaning the computer monitor screen. Do not use abrasive
2. Remove the lid of the water reservoir carefully and materials or chemicals or liquids.
dispose of the waste water.

To reattach the reservoir


COPY OF MANUAL
To obtain a copy of the Intelect RPW 2 User Manual, contact
1. Replace the reservoir lid and insert the water tube into the
your local representative or DJO Global® Customer Care
opening on the top
2. Place the reservoir against the Intelect RPW 2 above the
connection clip INSTRUCTION FOR SOFTWARE UPGRADE
3. Slide the reservoir down. Press down gently and there will 1. Download firmware upgrade from the Chattanooga®
be an audible click. The release clip will still be visible after website www.chattanoogarehab.com onto the USB stick.
the water reservoir is installed. 2. Switch OFF the device
3. Insert USB key
4. Switch ON the device
5. Device will automatically detect firmware update availability
6. Confirm firmware update

DEVICE MAINTENANCE
No internal maintenance or routine calibration is required for
the device itself.
For the Falcon® and V-Actor HF® handpieces along with the
transmitters, please refer to the correct section in this user
manual.
Power cable replacement: Unplug the default cable, then plug
the new cable.

*Falcon and V-Actor are registered trade marks of Storz medical AG

INTELECT® RPW 2 USER MANUAL


77 FALCON HANDPIECE CLEANING, MAINTENANCE; OVERHAUL EN

FALCON® HANDPIECE CLEANING, MAINTENANCE; OVERHAUL

CLEANING
Regular cleaning ensures perfect hygiene and operation of the Falcon® handpiece. The handpiece, in particular the shock
transmitter, must be thoroughly cleaned and disinfected after each therapy session.

Caut i on!
Flammable and volatile cleaning and disinfecting agents may generate an explosive atmosphere.
Disconnect the handpiece from the control unit before starting any cleaning or maintenance work.

At t ent i on!
It is essential that no fluid be permitted to penetrate either the device or its tubing.

• Clean the coupling gel off the handpiece using a cleaning agent that is suitable for surface cleaning.
• Disinfect the handpiece with an alcohol-based disinfectant that is suitable for surface cleaning.

Component Procedure Interval


daily
Handpiece shaft and cushion clean and disinfect
or after 20,000 shocks (whichever comes first)
Guide tube clean from inside with brush every day

Shock transmitters and O-rings clean in ultrasonic bath and disinfect after each treatment or contact with a patient

Guide tube, projectile and O-rings replace after 1,000,000 shocks (overhaul the handpiece)

*Falcon is a registered trade mark of Storz medical AG

INTELECT® RPW 2 USER MANUAL


78 CLEANING, MAINTENANCE, OVERHAUL EN

STANDARD SHOCK TRANSMITTERS 5. Screw the shock transmitter screw cap onto the
handpiece until finger-tight.
1. Disconnect the handpiece from the control device.
2. Unscrew the shock transmitter screw cap from the
handpiece.

6. After replacing the shock transmitter, make sure that the


handpiece cap and the cap parts are screwed firmly in place.

3. Remove the shock transmitter insert.

Note: Make sure that the cap parts of the shock transmitters are
screwed firmly in place and that the shock transmitter screw cap is
screwed firmly to the shaft.
4. Insert the shock transmitter insert into the corresponding Check the screw connection of the shock transmitter screw cap and
shock transmitter screw cap. cap parts during prolonged treatment phases.

INTELECT® RPW 2 USER MANUAL


79 CLEANING, MAINTENANCE, OVERHAUL EN

SPINE AND FASCIAE SHOCK 4. Push the inner part of the clutch in direction to the shaft
of the handpiece (1).
TRANSMITTERS
• Push the shock transmitter into the clutch (2).
1. Disconnect the handpiece from the control device.
The spine or fasciae transmitter set contents a special clutch
for mounting the spine or fasciae transmitters. The shock
transmitter can only be mounted if the clutch has already
been screwed on the handpiece.
2. Screw the clutch onto the handpiece.

5. Release the inner part of the clutch.


• The shock transmitter engages into its place.

3. Take out the desired shock transmitter from the case.

Note: Before starting with treatment make sure that the shock
transmitter is engaged into its place.

6. To disassemble the shock transmitter proceed as follows:


• Push the inner part of the clutch in direction to the
shaft of the handpiece
• Pull the shock transmitter out of the clutch.

INTELECT® RPW 2 USER MANUAL


80 CLEANING, MAINTENANCE, OVERHAUL EN

CLEANING THE HANDPIECE 4. Unscrew the shaft from the handpiece and pull it out of
the handpiece handle (5).
Note: After cleaning, the handpiece must be dry before it can be
reassembled. For that reason, schedule sufficient time for the drying • Use the supplied open-end spanner (4) for this
of the handpiece and its components. purpose.

1. Disconnect the handpiece from the control device.


2. Unscrew the shock transmitter screw cap respectively
the clutch for the spine and fasciae shock transmitters from
the handpiece.

5. Clean the guide tube with a brush in order to ensure


perfect projectile movement.

3. Clean the coupling gel off the handpiece using a cleaning


agent that is suitable for surface cleaning.
• Disinfect the handpiece with an alcohol-based
disinfectant that is suitable for surface cleaning

The assembly of the handpiece is carried out in reverse


order.
Note: When mounting the shaft of the handpiece it is necessary to
tighten it using the supplied open-end spanner The shaft may no
longer be solved manually.

INTELECT® RPW 2 USER MANUAL


81 CLEANING, MAINTENANCE, OVERHAUL EN

CLEANING THE SHOCK TRANSMITTERS Note: The shock transmitter insert of two-part transmitter caps can
only be dismantled and the sealing rings can only be removed using
special tools. You should avoid doing this because it could result in
damage to the shock transmitter. It is not necessary for cleaning
purposes.
STANDARD SHOCK TRANSMITTERS
• Unscrew the shock transmitter screw cap and
remove the shock transmitter insert from the shock
transmitter screw cap.
• Clean all of the parts under running water.

INTELECT® RPW 2 USER MANUAL


82 CLEANING, MAINTENANCE, OVERHAUL EN

• After shockwave application for humans an SPINE AND FASCIAE SHOCK


ultrasonic bath of our shockwave transmitters can
TRANSMITTERS
have an additional cleaning effect. However, an
ultrasonic bath is not a requirement. • Remove the applicator from the handpiece and

• For this purpose, use only instrument disinfectants disconnect it from the coupling.

for heat-sensitive, reusable medical devices. • Remove the residuals of coupling gel immediately
after each treatment with a damp cloth.

Note: If coupling gel remains on the applicators or the clutch,


corrosion occurs on the metal parts.

• Clean and disinfect the spine and fasciae shock


transmitters in ultrasonic bath with a temperature
from maximum 40°C.
• Allow shock transmitters to dry before you put them
back in the case.

• Clean and disinfect not only the shock transmitter


insert but also the shock transmitter screw cap CLUTCH FOR THE SPINE / FASCIAE
with the usual alcohol-based cleaning agents and SHOCK TRANSMITTERS
disinfectants.
• Clean the clutch from coupling gel or residual oil
• Dry the transmitter and shock transmitter screw cap using a damp cloth.
before screwing them together.
• Disinfect the clutch with an alcohol-based
• Push the insert into the front cap and screw the two disinfectant that is suitable for surface cleaning.
cap parts together until finger-tight.
• Spray alcohol-based disinfectant spray in the
mountage opening for the transmitter.
Note: Make sure that the cap parts of the shock transmitters are
screwed firmly in place and that the shock transmitter screw cap is • Clean the inside of the clutch using cotton buds.
screwed firmly to the shaft.
Check the screw connection of the shock transmitter screw cap and
cap parts during prolonged treatment phases.

INTELECT® RPW 2 USER MANUAL


83 CLEANING, MAINTENANCE, OVERHAUL EN

OVERHAUL
Shock waves are generated mechanically. Due to the effects of friction, the handpiece components are continuously exposed to
mechanical stress, which will cause minor wear.

Note: The Falcon* handpiece should be overhauled about every 1,000,000 shocks. This can be done by the user of the device. All that is required is
the overhaul kit, which includes all required wear parts.

Note: The sealing rings, the projectile and the guide tube must always be replaced each time the handpiece is overhauled. Observe the O-ring Guide
when selecting the sealing rings to be used. It is contained in the overhaul kit.

OVERHAULING THE HANDPIECE


• Flammable and volatile cleaning and disinfecting agents may generate an explosive atmosphere.
• Disconnect the handpiece from the control unit before starting any cleaning or maintenance work.

At t ent i on!
An open end spanner has to be used to release or to assemble handpiece shaft when overhauling
the handpiece.

• Place the handpiece on a dry, clean and dust-free surface.

*Falcon is a registered trade mark of Storz medical AG

INTELECT® RPW 2 USER MANUAL


84 CLEANING, MAINTENANCE, OVERHAUL EN

1. Disconnect the handpiece from the control device. 3. Pull the tightly fitting guide tube out of the shaft. If
• Unscrew the shock transmitter screw cap necessary, use a thin metal rod or the supplied hexagonal
respectively the clutch for the spine and fasciae spanner as a pulling tool by inserting it through the
shock transmitters from the handpiece. openings in the guide tube.

4. A corresponding fixture is provided in the handpiece


2. Unscrew the shaft from the handpiece and pull it out of
handle to hold back the projectile. To remove the projectile,
the handpiece handle.
hold the handpiece handle with its opening pointing down.
• Use the supplied open-end spanner (3) for this
Gently knock the handle against the table surface until the
purpose.
projectile falls out. In the event that the projectile breaks
apart due to overloading, a fragment of the projectile may
be left behind inside the guide tube.

INTELECT® RPW 2 USER MANUAL


85 CLEANING, MAINTENANCE, OVERHAUL EN

5. Dispose of the used guide tube and the used projectile 7. Clean the shaft, the shock transmitter (including firmly
seated sealing rings) and the shock transmitter screw cap
using a disinfectant containing alcohol. These are reused
after cleaning.

6. Dispose of the detachable sealing rings of the C15, DI15,


F15, B15, T10 shock transmitters and the sealing ring on the
shaft.
Note: The shock transmitter insert of two-part transmitter caps can
only be dismantled and the sealing rings can only be removed using
special tools. You should avoid doing this because it could result in
damage to the shock transmitter. It is not necessary for cleaning
purposes.

8. Now, from the overhaul kit, take out the new sealing
rings and for the shaft and install them. Observe the O-ring
Guide for this purpose. It is contained in the overhaul kit.

INTELECT® RPW 2 USER MANUAL


86 CLEANING, MAINTENANCE, OVERHAUL EN

9. Take out the new guide tube and the new projectile from 11. Insert the new projectile into the fitted guide tube.
the overhaul kit.

12. Screw the shaft into the handpiece until finger-tight.


10. Insert the guide tube into the opening in the shaft by • Using one hand, press the handpiece firmly onto
pressing in until the stop. the table and tighten the shaft using the open-end
spanner. It must no longer be possible to unscrew
IMPORTANT: Make sure that the end of the guide tube the shaft by hand.
where the two air slots are located is in the direction of the
handpiece handle.

13. 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.
• Carry out a functional check of the handpiece

INTELECT® RPW 2 USER MANUAL


87 SERVICE AND WARRANTY EN

SERVICE LIFE OF THE FALCON®


HANDPIECE
The Falcon* handpiece should be overhauled after around
every 1 million shocks. Provided this interval is observed, the
average expected service life is approx.
• 5 million shocks for the handpiece
• 1 million shocks for the shock transmitters
• 5 million shocks for the clutch.

Exceeding the service life can be expected to result in a


failure of the devices. No warranty claims shall be accepted
beyond the information given.

SERVICE LIFE OF THE V-ACTOR HF®


HANDPIECE
The average expected service life of the handpiece is approx.
5 million pulses. Exceeding the service life can be expected
to result in a failure of the devices.

No warranty claims shall be accepted beyond the


information given in the warranty section of this manual.

*Falcon and V-Actor are registered trade marks of Storz medical AG

INTELECT® RPW 2 USER MANUAL


88 SERVICE AND WARRANTY EN

SERVICE & WARRANTY Falcon and V-Actor Handpieces


When disposing of this product, no special measures have to
be observed. Please proceed in accordance with applicable
country-specifc regulations.
WARRANTY REPAIR/OUT OF WARRANTY Additionally, after expiration of the service life of the
REPAIR handpiece, please return the device to DJO Global.

Service
When the Intelect® RPW 2 or any accessories require service,
contact the selling dealer or your DJO Service Department
contact.

Service to these devices should be performed only by a


service technician certified by DJO.

Expected Life
The product as well as the parts and accessories supplied
with it are designed for a minimum service life of 5 years of
normal usage and proper maintenance.

Transmitters, guiding tube, projectile, transmitters and


o-rings are consumables, they are designed for 1 million
shocks expected life.

Ultrasound gel has a shelf life that is lower than the life
expectancy of the device, handpieces, and other accessories.
Shelf life is indicated on the gel bottle itself.

Handpiece Repair
Repair work on defective handpieces must only be carried
out by personnel suitably authorised by DJO Global. Only
original DJO Global parts may be used for this purpose. The
suitably authorised personnel can be from DJO Global or be
representatives of DJO Global agencies and dealers.

DISPOSAL
Intelect RPW 2
When disposing of this medical product, no special
measures have to be observed. Please proceed in
accordance with applicable country specific regulations.
After expiration of its service life, dispose of the
Intelect RPW 2 as waste electronic equipment.

INTELECT® RPW 2 USER MANUAL


89 SERVICE AND WARRANTY EN

WARRANTY COMPANY SHALL NOT BE LIABLE IN ANY EVENT FOR


INCIDENTAL OR CONSEQUENTIAL DAMAGES.
Attention
Modifications to the device or handpiece are not permitted. This warranty gives you specific legal rights and you
Any unauthorized opening, repair or modification of may also have other rights which vary from location to
the device by unauthorized personnel will relieve the location. The Company does not authorize any person or
manufacturer of its liability and responsibility for safe system representative to create for it any other obligation or liability
operation. This will automatically void the warranty even in connection with the sale of the Product.
before the end of the warranty period. Any representative or agreement not contained in the
warranty shall be void and of no effect.
DJO FRANCE (“Company”) warrants that the Intelect®
RPW 2 (“Product”) are free of defects in material and THE FOREGOING WARRANTY IS IN LIEU OF ALL OTHER
workmanship. This warranty shall remain in effect for WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING ANY
three years (36 months) from the date of original consumer WARRANTY OR MERCHANTABILITY OR FITNESS FOR A
purchase. During the three-year warranty period from the PARTICULAR PURPOSE.
date of delivery of the product to the end customer, defects
will be remedied at no charge to the customer upon the
customer furnishing adequate proof that the defect is due to
defects in material or workmanship.

- The warranty for the handpiece is two years or three


million shocks, whatever occurs first.
- The warranty for the shock transmitters is one year or one
million shocks, whatever occurs fist.
- The consumables are not covered by the handpiece’s
warranty.
- Valid only in case proper revision of the handpiece is
performed every 1 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.
• The Company is not responsible for injury or damage
resulting from modifications or service performed by
non-authorized Company service personnel.

INTELECT® RPW 2 USER MANUAL


90 APPENDIX EN

ELECTROMAGNETIC COMPATIBILITY Compatibility of Medical Devices for Clinical/Biomedical


Engineers. AAMI TIR 18-1997. Arlington, Virginia: Association
(EMC)
for the Advancement of Medical Instrumentation; 1997.
The Intelect® RPW 2 has been tested and found to comply
Caution:
with the electromagnetic compatibility (EMC) limits
Medical electrical equipment requires special precautions
for medical devices to IEC 60601-1-2. These limits are
regarding EMC and must be installed and operated
designed to provide reasonable protection against harmful
according to these instructions. It is possible that
interference in a typical medical installation.
high levels of radiated or conducted radio-frequency
electromagnetic interference (EMI) from portable and
The guidelines below are intended to help promote
mobile RF communications equipment or other
electromagnetic compatibility (EMC) in the identified use
strong or nearby radio-frequency sources, could result in
environment for the Intelect® RPW 2.
performance disruption of the ultrasound system.
• Make use of available resources such as EMC
Evidence of disruption may include image degradation or
professionals and publications and Internet web
distortion, erratic readings, equipment ceasing to operate, or
pages on the subject of medical device EMC;
other incorrect functioning. If this occurs, survey
• Assess the electromagnetic environment of the
the site of disruption, and take the following actions to
facility (e.g., identify radio transmitters in around
eliminate the source(s).
the facility) and identify areas where critical medical
• Turn equipment in the vicinity off and on to isolate
devices are used;
disruptive equipment.
• Manage the electromagnetic environment, RF
• Relocate or re-orient interfering equipment.
transmitters and all electrical and electronic
• Increase distance between interfering equipment and
equipment, including medical devices, to reduce the
your ultrasound system.
risk of medical device electromagnetic interference
• Manage use of frequencies close to ultrasound
(EMI) and achieve EMC;
system frequencies.
• Coordinate the purchase, installation, service,
• Remove devices that are highly susceptible to EMI.
and management of all electrical and electronic
• Lower power from internal sources within the facility
equipment used in the facility to achieve EMC;
control (such as paging systems).
• Educate healthcare facility staff, contractors, visitors,
• Label devices susceptible to EMI.
and patients about EMC and EMI and how they can
• Educate clinical staff to recognize potential
recognize medical device EMI and help minimize
EMI- related problems.
associated risks;
• Eliminate or reduce EMI with technical solutions
• Establish and implement written policies and
(such as shielding).
procedures that document the intentions and
• Restrict use of personal communicators (cell phones,
methods of the healthcare institution for reducing
computers) in areas with devices susceptible to EMI.
the risk of medical device EMI and achieving EMC;
• Share relevant EMI information with others,
• Report EMI problems to the US FDA MedWatch
particularly when evaluating new equipment
program and communicate EMI/EMC experiences to
purchases which may generate EMI.
colleagues in open forums such as medical/technical
• Purchase medical devices that comply with IEC
publications and conferences.
60601- 1-2 EMC Standards (3V/meter EMI immunity,
limit interference level to 0.0014 V/meter).
More information is contained within a comprehensive
guidance document for EMC in healthcare facilities,
developed, with FDA participation, by the Association for the
Advancement of Medical Instrumentation (AAMI): Technical
Information Report (TIR) 18, Guidance on Electromagnetic

INTELECT® RPW 2 USER MANUAL


91 APPENDIX EN

ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES


The product designation Intelect® RPW 2 used in the text below includes all their variants.

The Intelect RPW 2 device is subject to particular precautions regarding electromagnetic compatibility (EMC). The device must
be installed and put into service strictly in compliance with the EMC directives set forth in the accompanying documents.

The Intelect RPW 2 device is subject to particular precautions regarding electromagnetic compatibility (EMC). The device must
be installed and put into service strictly in compliance with the EMC directives set forth in the accompanying documents.

Portable and mobile RF communication systems may affect the Intelect RPW 2.

The Intelect RPW 2 should not be used adjacent to or stacked with other equipment.

If adjacent or stacked use is necessary, Intelect RPW 2 should be observed to verify normal operation in the configuration in
which it will be used.

If you detect damage or malfunctions that may impair the safety of the patient or of the operator, have the device repaired
before using it.

If it is necessary to replace assemblies or cables, only the manufacturer‘s original parts must be used to ensure continued
compliance with EMC requirements after repair.

With regards to the electromagnetic compatibility, there is no maintenance operation required during the expected product life
time!

WA RNING !
Use of accessories and cables 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.

INTELECT® RPW 2 USER MANUAL


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ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES (CONTINUED)

12.1 Electromagnetic emissions: Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

Intelect RPW 2 is intended for use in the electromagnetic environment specified below. It is the responsibility of the customer or user to ensure
that the Intelect RPW 2 device is used in such an environment.

Emissions Tests Compliance Electromagnetic Environment - Guidance

Intelect® RPW 2 uses RF energy for its internal function.


Additionally the Intelect RPW 2 contains a Bluetooth®
radio module, which complies with the national
RF emissions CISPR 11 Group 1 regulations. Therefore, its RF emissions are very low
and are not likely to cause any interference in nearby
electronic equipment. However, a separation distance
of 30 cm shall be maintained.

RF emissions to CISPR 11 Class B


Intelect RPW 2 is suitable for use in all establishments,
Harmonic emissions to complies with class other than domestic and those directly connected to
IEC 61000-3-2 A requirements the public low-voltage power supply network that
Voltage fluctuations/flicker supplies buildings used for domestic purposes.
complies
emissions to IEC 61000-3-3

12.2 Electromagnetic immunity : Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

Intelect RPW 2 is intended for use in the electromagnetic environment specified below. It is the responsibility of the customer or user to ensure
that the Intelect RPW 2 device is used in such an environment.

Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - Guidance

Electrostatic
± 8 kV contact ± 8 kV contact Floors should be wood, concrete or ceramic tile. If floors are covered with
discharge (ESD) to
± 15 kV air ± 15 kV air synthetic material, the relative humidity should be at least 30%.
IEC 61000-4-2

Electrical fast transient/ ± 2 kV ± 2 kV


bursts to 100 kHz repetition 100 kHz repetition Mains power should be that of a typical commercial or hospital environment.
IEC 61000-4-4 frequency frequency

Surges to ± 1kV Line to Line ± 1kV Line to Line


Mains power should be that of a typical commercial or hospital environment.
IEC 61000-4-5 ± 2kV Line to Earth ± 2kV Line to Earth

0% UT ; 0,5 cycle at 0°, 45°, 90°, 135°, 0% UT ; 0,5 cycle at 0°, 45°, 90°, 135°,
Mains power should be that of a typical commercial or hospital environment.
180°, 225°, 270°, 315° 180°, 225°, 270°, 315°
Voltage dips If the user of the Intelect RPW 2 device requires continued operation during
0% UT ; 1 cycle and 0% UT ; 1 cycle and
To IEC 61000-4-11 power mains interruptions, it is recommended that the Intelect RPW 2 device be
70% UT ; 25/30 cycles 70% UT ; 25/30 cycles
powered from an uninterruptible power supply or a battery.
Single phase at 0° Single phase at 0°

Power frequency
(50/60 Hz) Power frequency magnetic fields should be at levels characteristics of a typical
30 A/m 30 A/m
magnetic field to location in a typical commercial or hospital environment.
IEC 61000-4-8

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

INTELECT® RPW 2 USER MANUAL


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ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES (CONTINUED)

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

Intelect® RPW 2 is intended for use in the electromagnetic environment specified below. It is the responsibility of the customer or user to ensure
that the Intelect RPW 2 device is used in such an environment.

Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - Guidance

6V 6V
Conducted RF
0,15MHz-80 MHz 0,15MHz-80 MHz
to IEC 61000-4-6
80% AM at 1kHz 80% AM at 1kHz

10 V/m 10 V/m
Radiated RF
80MHz-2,7GHz 80MHz-2,7GHz
to IEC 61000-4-3
80% AM at 1kHz 80% AM at 1kHz

27 V/m 27 V/m
380-390MHz 380-390MHz
PM 18Hz PM 18Hz

28 V/m 28 V/m
430-470MHz 430-470MHz
FM +/- 5kHz FM +/- 5kHz
1 kHz sine 1 kHz sine

9 V/m 9 V/m
704-787 MHz 704-787 MHz
PM 217Hz PM 217Hz
Proximity fields from RF
wireless communications 28 V/m 28 V/m
equipment 800-960 MHz 800-960 MHz
to IEC 61000-4-3 PM 18 Hz PM 18 Hz

28 V/m 28 V/m
1,7-1,99 GHz 1,7-1,99 GHz
PM 217 Hz PM 217 Hz

28V/m 28V/m
2,4GHz-2,57GHz 2,4GHz-2,57GHz
at PM 217Hz at PM 217Hz

9V/m 9V/m
5,1GHz-5,8GHz 5,1GHz-5,8GHz
at PM 217Hz at PM 217Hz

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile 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 2 exceeds the applicable RF compliance level above, the Intelect RPW 2 device 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 2 device.

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ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES (CONTINUED)


12.3 RF (Radio Frequency) Interference
EMC disturbance can affect the performance of the Intelect® RPW 2. To prevent the user from unacceptable risks the device runs
performance checks regularly during operation. This is what happens, if a problem is identified:

− an audio signal sounds


− the device stops immediately
− the message ERROR and an error code appear on the display

In this case you may attempt to restart the device by turning it briefly off and on with the power switch.

WA RNING !
Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches) to any part of the Intelect RPW 2, including cables
specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

INTELECT® RPW 2 USER MANUAL


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