Chattanooga Mobile 2 RPW USA User manual

User Manual
Mobile  RPW USA
Operation & Installation Instructions for Mobile 2 RPW USA (Radial Pressure Wave)
REF 2905-US
Rx only

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Mobile 2 RPW User Manual
Contents
1. General Information 
1.1 Introduction 
1.1.1 Indications 
1.1.2 Contraindications 
1.1.3 Warnings and precautions 
1.2 Symbols 
1.3 Prerequisites for operating the device 
1.3.1 Operator 
1.3.2 Training of the operator 
1.4 Description of controls and functional elements 
1.4.1 The device 
1.4.2 Compressed air supply 
2. Installation Instructions 
2.1 Unpacking 
2.2 Scope of supply 
2.3 Installation 
2.3.1 Handpiece holder installation 
2.3.2 Connecting power supply cables 
2.3.3 Handpiece connection 
2.3.4 Potential equalisation (optional) 
3. Operation 
3.1 General warnings and safety information 
3.2 Start-up 
3.3 Functional checks 
3.4 Standard settings 
3.5 Treatment 
3.6 Info menu 
3.7 Resetting the handpiece shock counter 
4. Cleaning, Maintenance, Overhaul 
4.1 Cleaning the instrument 
4.2 Device mains fuse replacement 
4.3 Filter replacement 
4.4 Maintenance 
4.5 Disposal 
4.6 Repair 
4.7 Service life 
5. Error Messages and Trouble-shooting 
5.1 Warnings 
5.2 Trouble-shooting 
6. Accessories and Spare Parts 

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Mobile 2 RPW User Manual
7. Technical Specifications of the Control Device 
7.1 Device 
7.2 Type plate 
7.3 Conformity with directives 
7.4 Conformity with standards 
8. R-SW handpiece Specifications and Operation 
8.1 Introduction 
8.2 Installing and Replacing the transmitter 
8.3 Cleaning of the handpiece 
8.4 Cleaning the transmitters 
8.5 R-SW handpiece overhaul 
8.5.1 Contents of the R-SW overhaul kit 
8.5.2 Overhauling the handpiece 
8.6 Maintenance 
8.7 Disposal 
8.8 Repair 
8.9 Service life 
8.10 Trouble -shooting 
8.11 Accessories and SpareParts 
8.12 Applicator Specifications 
9. V-ACTOR II Specifications and Operation 
9.1 Scope of supply 
9.2 Unpacking 
9.3 Connecting the handpiece 
9.4 Replacing the transmitter 
9.5 General warnings and safety information 
9.6 Setting the V-ACTOR ii treatment parameters 
9.7 Start-up 
9.8 Functional checks 
9.9 Standard settings 
9.10 Treatment 
9.11 Cleaning 
9.12 Disposal 
9.13 Repair 
9.14 Service life 
9.15 Trouble-shooting 
9.16. Accessories and Spare Parts 
9.17 Technical Specifications 
10. Warranty and Service 
10.1 Warranty 
10.2 Warranty for the handpiece 
10.3 Service 

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Mobile 2 RPW User Manual
1. General Information
. INTRODUCTION
This manual contains warnings, safety instructions and specific operating instructions in accordance with liability regulations.
DANGER
Refers to a situation of acute danger which, if not avoided, could lead to serious or fatal injury.
WARNING
Refers to a situation of potential danger which, if not avoided, could lead to serious or fatal injury.
CAUTION
Refers to a situation of potential danger which, if not avoided, could lead to minor injury.
ATTENTION
Warns against possibly harmful situations that could lead to damage to either the product or to the surrounding area.
NOTE
Additional information concerning specific features or operating instructions is preceded by the term “NOTE”.
CAUTION
Before you start using the device for the first time, please make sure you have read and understood all
information provided in this operating manual.
Familiarity with the information and instructions contained in this manual is essential for ensuring ecient
and optimal use of the instrument, for avoiding hazards to personnel and equipment and for obtaining good
treatment results.
Thorough knowledge of the information included in this manual will also enable you to react promptly and
eectively in the event of malfunctions and errors.
When using optional accessories, please also refer to the separate operating manuals for each of these
accessories. It is imperative that users be familiar with the content of this manual before operating any part
of this system.
The device is a compressed air-operated ballistic shock wave generator. The shock waves in the device are generated with a
precision ballistic mechanism in the handpiece. A projectile is accelerated by compressed air. The motion and weight of the projectile
produce kinetic energy. When the projectile impacts against an immovable surface, the shock transmitter, this kinetic energy is
converted into sound energy. This acoustic pulse is transmitted into the tissue to be treated directly with the help of a gel.
These waves are physically classified as radial pressure waves. The applied pressure pulse propagates radially within the tissue and
has a therapeutic eect on areas of the tissue near the surface, in particular.
NOTE
Medical devices operating on the basis of the above principle are generally referred to as radial shock wave systems in modern
medical literature.
CAUTION
Rx only :
Federal law restricts this device to sale by or on the order of a practitioner licensed by the law of the State in which
he/she practises to use or order the use of the device.

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Mobile 2 RPW User Manual
1. General Information
.. INDICATIONS
The device is a compact radial shock wave therapy system. Indications include:
• to relieve minor muscle aches and pains.
• temporary increase in local blood circulation.
• activation of connective tissue.
.. CONTRAINDICATIONS
The precautions listed here are examples.
No claims are made regarding the completeness or unlimited validity of this list of precautions.
Treatment with the device is not permitted in the following cases:
• malignant tumor in the treatment area
• fetus in the treatment area
This device should not be used over swollen or inflamed areas or skin eruptions.
Do not use in presence of unexplained calf pain.
There is a potential for discomfort when using the device on bony surfaces.
Be aware of the potential for bruising and hematoma!
Never use this device on children, the unconscious, or anyone who cannot give verbal consent or warnings about
pain.
.. WARNINGS AND PRECAUTIONS
• Do not use in the presence of unexplained pain.
• If a patient reports significant or unexpected pain, immediately stop the treatment and consult a physician.
• Do not apply pulses to any regions near large nerves, vessels, the spinal column or head.
• ALWAYS move the handpiece over the treatment area. Continuous repetitive pulses concentrated in one spot may lead to bruising.
• Use of this device may be painful or cause bruising. NEVER use this device on children, the unconscious, or anyone who cannot give
• verbal concent or warnings about pain.
• This device should not be used over swollen or inflamed areas or skin eruptions.
• Do not treat wounds, infected areas, skin tumors, open sores, or scars from recent surgery.
• Caution should be used over joints or bony prominence such as vertebrae.
CAUTION
CAUTION
NOTE
For the activation of connective tissue pressure not higher than 3bar and only D-ACTOR transmitters with a diameter of 20mm
and more shall be used.

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Mobile 2 RPW User Manual
1. General Information
. SYMBOLS
The markings on the Mobile 2 RPW USA system are your assurance of its conformity to the highest applicable standards of medical
equipment safety and electromagnetic compatibility. One or more of the following markings may appear on the device:
Type B Applied part
Potential equalisation
R-SW / V-ACTOR handpiece connection
Council Directive //EU concerning Waste Electrical and Electronic Equipment (WEEE).
Indicates a requirement not to dispose of WEEE as municipal waste. Contact your local
distributor for information regarding disposal of the unit and accessories.
Wear hearing protection!
USB connection
xx
Name and address of the manufacturer and manufacturing date.
Complies with the Medical Device Directive 93/42/EEC
CSA certification mark
Refer to Instruction Manual/Booklet
Fuse
Electromagnetic interference may occur in the vicinity of instruments marked with this symbol.
Hot surface

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Mobile 2 RPW User Manual
1. General Information
Explosion
. PREREQUISITES FOR OPERATING THE DEVICE
.. OPERATOR
The device is intended exclusively for use by medical specialists and may only be used by qualified and instructed medical persons.
Such a specialist is expected to have practical knowledge of medical procedures and applications as well as of the terminology, and
should be experienced in treating the indications stated in chapter ...
The specialist must have the basic physical and cognitive prerequisites such as vision, hearing and reading. Furthermore, the basic
functions of the upper extremities must be guaranteed. The instrument is designed for a demographic target group between  and
 years.
.. TRAINING OF THE OPERATOR
Operators of the device must have been adequately trained in using this system safely and eciently before they operate the
instrument described in this handbook. An introduction to the principles of operation will be provided by your dealer with reference
to this operating manual and will be documented in the system logbook.
The operator must be instructed in the following points:
•Instruction in operation and designated use of the instrument with practical exercises
•Mechanism of action and function of the instrument and the energies delivered by it
•All component settings
•Indications for use of the instrument
•Contraindications and side eects of the therapy waves
•Explanation of the warning notes in all operating statuses
•Instruction in how to perform the functional checks
Further training requirements vary from country to country. It is the operator’s responsibility to ensure that the training meets the
requirements of all applicable local laws and regulations. Further information on training in the operation of this system is available
from your dealer. However, you can also contact the following address directly:
DJO, LLC
 DECISION STREET
VISTA, CA 
USA
T: +  494 3395
E: [e-mail]

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Mobile 2 RPW User Manual
1. General Information
. DESCRIPTION OF CONTROLS AND FUNCTIONAL ELEMENTS
.. THE DEVICE
Fig.  -  Front view of the device
 Display of selected shock frequency
 Treatment shock counter
 Display of selected pressure (nominal value)
 Shock counter reset button
 Dial for setting the pressure
 Handpiece
 Handpiece connector
 Buttons for setting the shock frequency
Fig.  -  Side view of the device
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Mobile 2 RPW User Manual
1. General Information
Fig.  -  Rear view of the device
 Type plate
 USB connection
 Filter housing
 Mains connection
 Potential equalisation connection
 Mains fuse holder
 Mains switch
NOTE
The USB connection (Fig. -) is only suitable for connecting a USB memory stick which supports the USB V. protocol.
Fig.  -  Back cover of the device
.. COMPRESSED AIR SUPPLY
The compressed air is supplied by an integrated compressor.
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Mobile 2 RPW User Manual
2. Installation Instructions
. UNPACKING
• Carefully remove the instrument and accessories from the packaging container.
• Check that all items are included in the packaging container and that they are not damaged.
• Contact your supplier or the manufacturer immediately if any items are missing or damaged. Retain the original packaging.
It may prove useful for any later equipment transport.
. SCOPE OF SUPPLY
The standard scope of supply of the Mobile 2 RPW USA includes the following items:
• Control device
• R-SW handpiece
• Mains cables
• Gel bottle
• User manual
• Service set
• 2 Transmitters
Please refer to chapter  ACCESSORIES AND SPARE PARTS for information on optional accessories.

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Mobile 2 RPW User Manual
2. Installation Instructions
. INSTALLATION
.. HANDPIECE HOLDER INSTALLATION
• The handpiece can be placed on the right or on the left side of the system.
Fig.  -  Position of the handpiece holder
Fig.  -  Position of the handpiece holder

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Mobile 2 RPW User Manual
2. Installation Instructions
.. CONNECTING POWER SUPPLY CABLES
• Connect the supplied mains cable to the mains connection (Fig.  - /) on the rear of the instrument.
Fig.  -  Connecting power supply cables
• Insert the mains plug into the socket.
ATTENTION
When setting up the instrument, make sure that the air outlets on the housing of the device are not blocked.
The instrument must only be connected to properly earthed and correctly installed shockproof sockets!
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Mobile 2 RPW User Manual
2. Installation Instructions
.. HANDPIECE CONNECTION
• Connect the plug of the handpiece to the handpiece connection (Fig.  - /) on the device.
Fig.  -  Handpiece connection
• Make sure that the red dots on the connector match the red dots on the handpiece connection (Fig.  - ).
Fig.  -  Connecting the handpiece
• Place the handpiece into the handpiece holder.
.. POTENTIAL EQUALISATION OPTIONAL
The device features a potential equalisation connection (Fig.  - /). Where necessary, connections for potential equalisation must
be made by suitably qualified personnel.
The potential equalization connection must be connected in accordance with the relevant national regulations.
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CAUTION

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Mobile 2 RPW User Manual
3. Operation
. GENERAL WARNINGS AND SAFETY INFORMATION
CAUTION
The device is intended exclusively for use by medical specialists and may only be used by such suitably
qualified and trained medical personnel (see chapter . PREREQUISITES FOR OPERATING THE DEVICE).
The user is responsible for correctly positioning the handpieces of the device.
Correct determination of the location of the treatment zone is the responsibility of the user.
Only perform treatments approved by the manufacturer!
To avoid safety hazards, use of the instrument for applications other than those specified in chapter ..
INDICATIONS is not allowed!
The device has a potential equalisation connection. This must be connected in accordance with the relevant
national regulations.
Do not use the device in potentially explosive environments, i.e. in the presence of a flammable anaesthetic
mixture with air or with oxygen or nitrous oxide.
If instruments are connected that are not medical products as defined by EN IEC , they must be set up
outside the vicinity of the patient.
Cleaning agents and disinfectants can form an explosive atmosphere. Disconnect the device from the mains
before starting any cleaning or maintenance work!
Before any cleaning and maintenance work on the handpiece, disconnect the handpiece plug from the
handpiece connection! Do not connect the handpiece until it has been completely reassembled!
CAUTION
Do not try to open the instrument! Risk of electric shocks!
Risk of transmission of microorganisms! Disinfect the handpiece after each treatment!
Also refer to chapter  CLEANING, MAINTENANCE, OVERHAUL for details.
ATTENTION
Check that the installation surfaces have sucient carrying capacity to avoid equipment damage!
Portable and mobile HF communications equipment (e.g. mobile phones) can interfere with electrical equipment.
The use of accessories or cabling not authorised by the manufacturer may cause increased emissions or may lead to reduced
interference resistance of the device.
The device must neither be deployed nor stored together with other devices. If the operation near or jointly with other devices
is required, the device must be must be tested in that particular environment to ensure operation according to technical
specification. The device may be positioned and operated near the listed accessories.
The instrument must only be connected to properly earthed and correctly installed shockproof sockets!
Check that the instrument is in perfect working order before each use (see chapter . FUNCTIONAL CHECKS).
Never cover the instruments when in use!
Make absolutely sure that no liquid can seep into the system housing or handpiece.
Any damage to the instrument resulting from incorrect operation is not covered by the manufacturer’s warranty.
Disposal of the instrument and its components must be carried out in accordance with national waste disposal regulations.
The device must only be used with accessories that have been approved by the system manufacturer. To prevent safety hazards,
unauthorized system modifications are not allowed. This will void the CE mark approval and warranty.

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Mobile 2 RPW User Manual
3. Operation
NOTE
The device meets the requirements of the applicable electromagnetic compatibility (EMC) standards EN --.
These requirements are designed to provide reasonable protection against harmful interference in a typical medical
installation. The instrument described here generates and uses high-frequency energy and can emit the same. If not
installed and used in accordance with these instructions, the instrument may cause harmful interference with other devices
in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this product
does cause harmful interference with other devices, which can be determined by turning the instrument o and on, the
user is encouraged to try to correct the interference by one or more of the following measures:
• Reorient or relocate the receiving device.
• Increase the distance between the devices.
• Connect the devices to an outlet on a circuit dierent from that to which the other device is connected.
• Consult the manufacturer or field service technician for help.
. STARTUP
NOTE
Prior to start-up, please refer to chapter 8 and 9 for your handpiece.
• Switch on the device at the mains switch on the back of the instrument (Fig.  - /).
Once the unit has been started, the display automatically shows the last shock frequency setting. The display flashes.
• To confirm the existing setting, press one of the two arrow keys.
• To change the existing setting, press one of the two arrow keys. As soon as the display has stopped flashing, the selected shock
frequency can be increased or reduced using the arrow keys.
With the device, the shock wave frequency can be selected in steps.
Operating Mode Energy/Frequency
R-SW 1.0 - 4.0 bar / max. 21 Hz
R-SW 4.6 bar / max. 15 Hz
R-SW 5.0 bar / max. 12 Hz
V-ACTOR 1.4 - 3.0 bar / max. 31 Hz
V-ACTOR 3.8 bar / max. 22 Hz
V-ACTOR 5.0 bar / max. 13 Hz
• Set the energy of the shocks to an initial value of . bar using the dial (Fig. - /). The value is displayed on the pressure display (Fig. - /).

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Mobile 2 RPW User Manual
3. Operation
Fig.  -  Setting the energy on the control device
 Display of selected shock frequency
Treatment shock counter
 Display of selected pressure (nominal value)
Shock counter reset button
 Dial for setting the pressure
 Handpiece
Handpiece connector
Buttons for setting the shock frequency
The maximum application pressure is limited to bar. To ensure correct system operation, a minimum pressure of . bar is required.
• Press the trigger button on the handpiece.
• To work in single shock mode, select the “-” symbol (dash) in the “Frequency” selection box and activate the trigger button.
• To work in continuous shock mode, select a continuous shock frequency in the range from:
Operating Mode Energy/Frequency
R-SW 1.0 - 4.0 bar / max. 21 Hz
R-SW 4.6 bar / max. 15 Hz
R-SW 5.0 bar / max. 12 Hz
V-ACTOR 1.4 - 3.0 bar / max. 31 Hz
V-ACTOR 3.8 bar / max. 22 Hz
V-ACTOR 5.0 bar / max. 13 Hz
• Activate the trigger button.
NOTE
A pressure change automatically entails a change in frequency if the set frequency exceeds the maximum permitted
frequency (see Table  - )
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Mobile 2 RPW User Manual
3. Operation
. FUNCTIONAL CHECKS
Perform the following functional checks after the instrument has been installed:
• Check the control device and handpiece for damage.
• Put the device into operation.
• Set the pressure to . bar.
• Reset the treatment shock counter (Fig.  - /) with the reset button (Fig.  - /) on the front of the instrument.
• Release individual shocks in single shock mode.
• Release shocks in continuous shock mode (shock frequency  Hz and  Hz).
• Check that the triggered shocks are correctly counted on the treatment shock counter on the front of the instrument.
• Set the pressure to maximum  bar.
• Release individual shocks in single shock mode.
• Release shocks in continuous shock mode (shock frequency  Hz and  Hz).
• Test the other frequencies as follows:
Operating Mode Energy/Frequency
R-SW 4.0 bar / max. 21 Hz
R-SW 4.6 bar / max. 15 Hz
R-SW 5.0 bar / max. 12 Hz
V-ACTOR 3.0 bar / max. 31 Hz
V-ACTOR 3.8 bar / max. 22 Hz
V-ACTOR 5.0 bar / max. 13 Hz
. STANDARD SETTINGS
• Before each treatment, set the treatment shock counter (Fig.  - /) on the control device to zero by pressing the reset
button (Fig.  - /).
• A total of about , shocks must generally be applied per therapy session. Please refer to the device application
brochure for details.
• Start the treatment at a pressure of  bar and a frequency of  Hz.

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Mobile 2 RPW User Manual
3. Operation
. TREATMENT
CAUTION
The transport bag is provided only to transport the device. If the device is left in the transport bag during
treatment, the device becomes hot, due to lack of ventilation. Burns, conflagration and damages of the
device are possible.
•Take the device out of the transport bag during treatment.
CAUTION
Read chapter . GENERAL WARNINGS AND SAFETY INFORMATION before beginning treatment.
Please also follow the instructions in chapter 8 and 9 for your handpiece.
Each time after the instrument has been transported, make sure that all functional checks have been
performed on the instrument before you start treatment.
Only perform treatments approved by the manufacturer!
To avoid safety hazards, use of the instrument for applications other than those specified in chapter ..
INDICATIONS is not allowed!
All status and error messages signaled during treatment must always be attended to
without delay!
The maximum energy level used during treatment must not cause the patient undue pain under any
circumstances.
CAUTION
We recommend that the user and the patient wear suitable hearing protection.
• Always oer the patient hearing protection.
• Apply a sucient amount of coupling gel to the patient’s skin in the treatment area and to the shock
transmitter.
• Do not apply more than  shocks to the same spot during treatment.
• Avoid excessive pressure of the shock transmitter to the patient’s skin. Excessive pressure is not necessary
for the success of the treatment.
CAUTION
The shock transmitter surface temperature can reach up to 47°C. Extended skin contact can lead to minor
burns!
• Interrupt treatment after a maximum of , pulses.
CAUTION
The handpiece may not be operated while idling (without an impact surface).
• Do not trigger pulses unless the pulse transmitter is in contact with the treatment zone!

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Mobile 2 RPW User Manual
3. Operation
. INFO MENU
The Info menu enables you to reset the handpiece counter, to call up the total shock count and instrument operating hours as well
as to read out data on monitoring software, hardware serial numbers and modification status.
• To activate the Info menu, press both arrow keys simultaneously and hold them for two seconds.
The display changes to Info mode: The top line (nominal energy display) shows the menu item in question as a number between 
and . (Fig.  - /), whereas the middle line (Fig.  - /) shows the called-up information (in this case: hardware article no.).
Fig.  -  Info mode
• Use the dial to move up or down in the menu in order to call up the following data:
Menu Item Display
 Handpiece pulse counter
 Total pulse counter
 Operating hours counter
 Hardware article no.
 Hardware change index
 Not used
 Software article no.
 Software change index
 Boot loader article no.
 Not used
NOTE
Shock counter displays  and  display the shock count in steps of one thousand.
• To exit the Info menu, press both arrow keys simultaneously and hold them for two seconds.
. RESETTING THE HANDPIECE SHOCK COUNTER
• Switch to Info mode (see chapter . INFO MENU).
• Select menu item  - Handpiece counter.
The number of shocks is displayed in steps of one thousand. The value displayed in the middle line multiplied by , gives the
counter reading for the current handpiece.
• Press the reset button to set the handpiece counter to zero.
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Mobile 2 RPW User Manual
4. Cleaning, Maintenance, Overhaul
. CLEANING THE INSTRUMENT
• Wipe the exterior of the housing with a damp cloth. Use soapy water or a mild cleaning agent.
ATTENTION
It is essential that no fluid be permitted to penetrate either the instrument or its tubing.
. DEVICE MAINS FUSE REPLACEMENT
The mains fuse holder is located on the rear panel of the device.
• Push the clip of the mains fuse holder (Fig.  - /) to the left and take the
holder o the housing.
Fig. 4 - 1 Mains fuse holder
• Pull the old fuses out of the mains fuse holder (Fig.  - ).
Fig.  -  Fuse replacement
• Replace the fuses.
• Use type TAL/ VAC fuses.
• Push the mains fuse holder back into the opening until it engages.
CAUTION
Disconnect the instrument from the mains before starting any cleaning or overhaul work!