Intelect® RPW $ User Manual
Intelect® RPW $ User Manual
Intelect® RPW 2
User Manual
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
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
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
SHOCK TRANSMITTERS
ACCESSORIES 64 HANDPIECE 72
WARRANTY 89
DEVICE MAINTENANCE 76
COPY OF MANUAL 76
DEVICE MAINTENANCE 76
CLEANING 77
TRANSMITTERS
OVERHAUL 83
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.
This end up
Keep dry
Temperature Range
Testing agency
Class 1 equipment
Shelf life
Batch number
No condensation allowed
Increasing Circulation
promotes blood flow through the
tissue and boosting metabolism.
Tendinosis Calcarea/Supraspinatus-Tendon
Shoulder calcifications and chronic shoulder pain
Achillodynia
Pain due to inflammation of the Achilles tendon or the bursa
associated with it.
CONTRAINDICATIONS
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
Polyvinylidenfluorid EpoFlon –
SPINE ACTORS Type B
ECTFE (Halar)
Ultrasonic gel Water de-ionized water Gel (PH7) Type B
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.
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
Pouch
Gel Holder
Cable Holders
SYSTEM START-UP
Complete the following steps for start-up of the Intelect®
RPW 2:
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.
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.
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.
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
6. The Gel Holder cup can be attached on the any side of the
device
DEVICE DESCRIPTION
Handle
Power Button
Rotary adjustment
Falcon Hand Piece Support
knob
Switch
ON/OFF USB Connector
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.
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)
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.
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.
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
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
V Actor status:
Falcon status:
Available
Available
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
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.
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.
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
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:
Educational library:
· Modality descriptions
· Anatomical images
· Pathological images
Parameters
Select transmitter
GUIDELINES SCREEN
The Guidelines provide the following information:
Modality description, terms, indications and contraindications, treatment guidelines
Swipe horizontally
for more
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.
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.
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.
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.
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.
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.
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.
3. Select INDICATION
4. Select INDICATION
5. SELECT MODALITY
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
7. START TREATMENT
Press the START button
Treatment Running
TREATMENT DATA
After a treatment has been completed, Treatment data can be saved on the Intelect® RPW 2 for later use on the device.
The TREATMENT HISTORY is displayed including all previously saved treatment sessions ranked chronologically
Delete one ID
Confirm or cancel
CUSTOM PROTOCOLS
The Intelect® RPW 2 allows for a maximum of 25 custom protocols to be defined.
Note: it is also possible the overwrite the default settings of the modality instead of saving to custom protocols.
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
Alphabetical list
Swipe to see more
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 .
Once assigned the shortcut icon becomes the color associated with the modality it contains
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.
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:
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.
MODALITY DESCRIPTIONS
Complete the following steps to view the Radial Pressure Wave and Vibration therapy descriptions:
1. Select one of the modality description
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
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
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
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.
13-28660* Quick Start Guide (Available in multiple languages with each unit)
POWER CORDS
Model Number Description
OPTIONAL ACCESSORIES
Model Number Description
19365 V-Actor® HF
Falcon, D-Actor® and V-Actor® are registered trade marks of Storz medical AG
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.
1 2 3
1: Red dots
2: Outside of
plug body
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.
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
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.
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
2
1
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
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.
bath.
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
TECHNICAL SPECIFICATIONS
V-ACTOR handpiece
Ambient air pressure during storage and transport 500 – 1060 HPA
– 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.
Label Meaning
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.
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.
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.
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.
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)
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.
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.
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.
Note: Before starting with treatment make sure that the shock
transmitter is engaged into its place.
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.
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.
• 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.
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.
At t ent i on!
An open end spanner has to be used to release or to assemble handpiece shaft when overhauling
the handpiece.
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.
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.
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.
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.
Service
When the Intelect® RPW 2 or any accessories require service,
contact the selling dealer or your DJO Service Department
contact.
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.
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.
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 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.
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
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 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.
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.
Copyright © [2019] by DJO, LLC All rights reserved. No part of this publication may be reproduced, distributed, or transmitted in any form or by any means.