Chattanooga Intelect Focus Shockwave User manual

Focus Shockwave
Operating Manual

13 610 0002 11.2022
1
Contents
Contents
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 4
1 General Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 7
1.1 Instructions for safe use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 7
1.1.1 Intended Use and Operational Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 7
1.1.2 Safety during treatment of the patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 9
1.1.3 Warning against damage to equipment and the device . . . . . . . . . . . . . . . . . . . . . . . . .. 9
1.2 Manufacturer`s Responsibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 11
1.3 Owner`s Responsibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 11
2 Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 12
2.1 Physical principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 12
2.1.1 Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 12
2.1.2 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 13
2.1.3 Side effects. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 14
2.2 Preconditions for operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 14
2.2.1 Operating personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 14
2.2.2 Training of the operator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 15
3 System description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 16
3.1 Control and functional elements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 16
3.2 F-SW handpiece and optional C-ACTOR handpiece . . . . . . . . . . . . . . . . . . . . . . . . .. 18
3.3 Use of stand-off devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 18
4 Installation Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 20
4.1 Scope of Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 20
4.2 Unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 20
4.3 Correct Positioning of the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 20
4.4 Installing the handpiece holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 21
4.5 Installing the holding arm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 21
4.6 Connecting the electrical power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 22
4.7 Connecting Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 23
4.8 Connecting an optional foot switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 23
4.9 Potential equalisation connector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 23
4.10 USB connection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 23
4.11 Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 24
4.12 Compatibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 24
5 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 25
5.1 Graphical user interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 25
5.2 Function overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 28
5.3 Starting the instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 30
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5.4 Setting treatment parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
5.5 F-SW energy display task . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
5.6 Store treatment notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
5.7 Loading treatment parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
5.7.1 Pre-programmed indications from the manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
5.7.2 In-house applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
5.8 Loading patient data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
5.9 Visual analogue scale (VAS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
5.10 Data transfer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
5.11 Resetting the treatment shock counter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
5.12 "Autofrequency" function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
5.13 Start-up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
5.14 Functional checks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
5.15 Standard settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
5.16 Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
5.17 Switching Off the Device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
6 Cleaning, care and maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
6.1 Cleaning the device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
6.2 Cleaning the handpieces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
6.2.1 Changing the stand-off device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
6.2.2 Reprocessing the handpiece and the stand-off devices. . . . . . . . . . . . . . . . . . . . . . . . . . . 50
6.2.2.1 Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
6.2.2.2 Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
6.2.3 Cleaning the optional foot switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
6.3 Water renewal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
6.3.1 Draining the water circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
6.3.2 Filling the water circuit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
6.3.3 Bleeding the water circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
6.3.4 Resetting the water renewal time. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
6.4 Mains fuse replacement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
6.5 Cybersecurity measures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
6.6 Software updates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
6.7 Maintenance and safety checks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
6.8 Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
6.9 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
6.10 Service life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
7 Status messages, error messages / fault displays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
7.1 Status messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
7.2 Trouble shooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
8 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
9 Technical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
9.1 Type plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
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9.2 Conformity with directives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 66
9.3 Conformity with standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 67
9.3.1 EMC guidelines and manufacturer's declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 67
9.4 Certificates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 71
9.5 Symbols and labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 72
10 Warranty and service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 75
10.1 Warranty for the control device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 75
10.2 Warranty for the handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 75
10.3 Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 75
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Introduction
Introduction
This operating manual contains certain types of text design intended to assist you in
comprehending the significance of the text based on its appearance.
Instructions for actions
• This text instructs you in how to operate your device correctly.
• This text subdivides an action into steps or comments on the action step.
This text shows the result of an action.
Lists
– This text is part of a list.
Menus and buttons
Names of MENUS and BUTTONS are greyed out and highlighted in small caps.
The operating procedure descriptions also contain references to the buttons that you
have to press and what you can expect to see in the text.
Cross references to other chapters
Cross references to other chapters are highlighted in bold and in small caps.
Warning notes
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 se-
rious or fatal injury.
DANGER
The source of the danger is stated here.
These are the possible consequences!
►The instructions for avoiding the danger are given here.
WARNING refers to a situation of potential danger which, if not avoided, could lead
to serious injury.
WARNING
The source of the danger is stated here.
These are possible consequences!
►The instructions for avoiding the danger are given here.
CAUTION indicates that incorrect operation could lead to minor injuries.
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Introduction
CAUTION
The source of the danger is stated here.
These are the possible consequences!
►The instructions for avoiding the danger are given here.
NOTICE indicates that incorrect operation could lead to damage to the device.
NOTICE
The source of the danger is stated here.
These are possible consequences!
►The instructions for avoiding the danger are given here.
Other instructions
This text indicates additional information concerning special features, etc. and/or op-
erating instructions.
Safety signs and other symbols used in this manual
Symbol Notification
General warning sign
Type B applied part
Potential equalisation
Disconnect mains plug
Wear hearing protection
USB connection
WEEE mark
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Introduction
Manufacturer
CE mark
Device serial number
CSA certification mark
It is essential to comply with the operat-
ing manual
Fuse
Electromagnetic interference may occur
in the vicinity of devices marked with this
symbol.
Hot surface
Explosion
Electrical warning sign: high voltage
Symbol Notification
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General Safety Information
1 General Safety Information
The following chapter contains all safety information that has to be followed when
working with the Chattanooga Intelect F-SW.
WARNING
Incorrect handling of the device
Possibility of injuries to the patient and the operating personnel!
►Read this chapter carefully before you start using the Chattanooga Intelect F-SW.
►Read the separate operating manuals for all devices associated with the Chatta-
nooga Intelect F-SW.
1.1 Instructions for safe use
1.1.1 Intended Use and Operational Safety
To use this device in accordance with its intended use, the user must possess the nec-
essary technical proficiency, and knowledge of the operating manual.
The device is intended exclusively for use by healthcare professionals who have been
trained to use the device (see also 2.2 PRECONDITIONS FOR OPERATION).
The device is only allowed to be used for the applications described in chapter 2.1.1
INDICATIONS. Only perform treatments approved by the manufacturer!
Furthermore, the device is only allowed to be operated by trained personnel who com-
ply with the preconditions for operation in the chapter 2.2 PRECONDITIONS FOR OPERA-
TION.
All status and error messages signaled during treatment must always be attended to
without delay.
While applying focused shockwaves at maximum adjustment, do not use more than
6.000 subsequent shocks and stick to a consecutive break of 5 minutes.
Checks and inspections prior to treatment
Before using the device, the user must make sure it is functioning safely and that it is
in proper condition.
• It is essential to perform the functional checks after switching on the Chattanooga
Intelect F-SW, before starting treatment. Read about this in Chapter 5.14 FUNCTIO-
NAL CHECKS.
• Have the maintenance procedures recommended by the manufacturer carried out
by personnel suitably authorised. Read about this in Chapter 6.7 MAINTENANCE
AND SAFETY CHECKS.
No treatment is permitted if a display on the control device or a touch screen fails.
Protection against electrical hazards
Sources of voltage can give rise to currents as a result of body resistance, which not
only flow through the patient but can also impair or even endanger the personnel ad-
ministering the treatment.
• Devices that are not medical products in accordance with EN 60601 must be set
up outside the patient environment.
• Do not touch electrical connectors while you are touching the patient.
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General Safety Information
• Disconnect the Chattanooga Intelect F-SW from the mains plug before starting
any cleaning or maintenance work.
• Disconnect the connected handpieces from the device before carrying out clean-
ing and maintenance work. Do not reconnect it until everything has been com-
pletely reassembled.
• Do not try to open the device! Risk of electric shocks!
• Always connect the potential equalisation connector of the Chattanooga Intelect
F-SW in accordance with national guidelines.
Protection against high voltage
High-voltage components are identified as follows:
DANGER
Contact with high-voltage parts:
Severe or fatal injury!
►Only operate the device if the housing is intact and closed
►Work in the area of high voltage is only allowed to be performed by personnel suit-
ably authorised by the manufacturer.
Protection against noise
The noise level during administration of shockwaves is within the safe range. Never-
theless, we recommend wearing suitable ear protection during treatment in order to
minimise exposure to noise.
Protection against explosion
The device is not allowed to be used in potentially explosive atmospheres (according
to classification AP and APG of IEC 60601-1) i.e. in the reach of anesthetic gas mixtures
with air, oxygen or nitrogen oxide.
DANGER
Risk of explosion due to flammable and explosive materials
Injuries to patients, people administering the treatment and third parties!
►During operation, avoid using the substances specified in the following section.
►Switch off the device before cleaning and disconnect the mains plug.
►Comply with the information on cleaning in Chapter 6 CLEANING, CARE AND MAIN-
TENANCE
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General Safety Information
The following agents are NOT to be used during operation:
– Highly inflammable and potentially explosive inhalation anaesthetics and mixtures
of the same, such as
•Ether pro narcosi (diethyl ether)
•Cyclopropane.
– Inflammable, highly volatile skin cleaning agents and skin disinfectants which can
form a potentially explosive atmosphere, such as
•Washing ether
•Petrol ether.
The optional foot switch must not be used in potentially explosive atmospheres accor-
ding to classification AP as per IEC 60601.
1.1.2 Safety during treatment of the patient
General note:
– Organs with gas inclusions, in particular parts of the lung, are NOT allowed to be
exposed to shock waves.
– As it passes through tissue, the shock wave’s energy is slightly reduced; this reduc-
tion is significantly weakened by the bone structure.
– Shock waves can give rise to undesirable heart reactions. The patient must be con-
tinuously observed during the treatment and attention must be paid to any reac-
tions experienced by the patient.
– The patient must not be under anaesthetic.
– Only perform treatments approved by the manufacturer!
– The user is responsible for correctly positioning the handpieces and correctly se-
lecting the treatment zone.
– Air bubbles reduce the effectiveness of shock waves. Therefore, air bubbles must
always be removed from the shock wave path.
– Risk of transmission of microorganisms! Disinfect the handpiece after each use!
For information about this, see 6 CLEANING, CARE AND MAINTENANCE.
While applying focused shockwaves at maximum adjustment, do not use more than
6.000 subsequent shocks and stick to a consecutive break of 5 minutes.
1.1.3 Warning against damage to equipment and the device
Any damage to the device resulting from incorrect operation is not covered by the
manufacturer's warranty.
Electromagnetic compatibility
This device complies with the requirements of the applicable standard on electromag-
netic compatibility.
Nevertheless, portable and mobile HF communications equipment (e.g. mobile
phones), including antennas, can interfere with medical electrical equipment. They
should not be used less than 30 cm from the device - including the cables specified by
the manufacturer.
This device is subject to special precautions regarding EMC and needs to be installed
according the EMC guidelines in chapter 9.3.1 EMC GUIDELINES AND MANUFACTURER'S
DECLARATION
The use of accessories or cables that are not authorised by the manufacturer can result
in increased interference emissions or reduced resistance to interference emissions by
the device.
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General Safety Information
The Chattanooga Intelect F-SW is not allowed to be positioned immediately next to,
stacked on or jointly with other devices. If operation near or jointly with other devices
is required, the Chattanooga Intelect F-SW must be tested in that particular environ-
ment to ensure operation according to technical specifications.
The device is not to be used within an MR environment. Within proximity of the device
to an Magnetic Resonance source device disturbances may occur. In case of distur-
bance consider repositioning of the device.
DANGER
Improper connection:
There is a risk of electric shock!
►Do not connect the device to a power supply network unless it has a protective
conductor.
►Never use multi-socket power strips.
Please read Chapter 9.3.1 EMC GUIDELINES AND MANUFACTURER'S DECLARATION.
If the Chattanooga Intelect F-SW is connected to a 240 V mains supply with a mains
frequency of 60 Hz, the mains supply must be balanced.
Setup and operation
There are ventilation slits on the device which must not be covered by other objects.
• Check that the installation surfaces have sufficient carrying capacity to avoid
equipment damage!
• Check that the device is in perfect working order before each use. Read about this
in Chapter 5.14 FUNCTIONAL CHECKS.
• Never cover the device when in use!
• Make absolutely sure that no liquid can seep into the system housing or hand-
piece.
Storage and transport
Incorrect storage and transport can result in damage to the device and device failure.
• Completely empty the water circuit and the handpiece before you transport the
device or put it into storage.
Otherwise, there is a risk of the water freezing, which will lead to damage. Please
contact your responsible Service centre if this does happen.
• Comply with the ambient conditions specified in Chapter 9 TECHNICAL SPECIFICATI-
ONS.
• Make sure that no cables are crushed or sheared.
• Make sure that the handpiece cable is not kinked.
• Do not pull on the handpiece or its cable in order to move the device.
• Always disconnect the handpiece from the control device properly.
Disposal
• Comply with national disposal regulations when disposing of the Chattanooga In-
telect F-SW or individual components.
• Comply with the relevant information in the operating manuals for the additional
devices.
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General Safety Information
1.2 Manufacturer`s Responsibility
WARNING
No modifications are to be made to this device without the permission of the manu-
facturer.
The manufacturer of the Chattanooga Intelect F-SW is only responsible for the impact
of its product on safety, reliability and performance if:
– maintenance of the device is performed at the intervals specified by the manufac-
turer
– installation, expansions, conversions, new installations, modifications or repairs
are performed by people authorised by the manufacturer
– the electrical installation in the rooms in question corresponds to the requirements
of DIN/IEC
– the device is used in compliance with the operating manual
The periodic maintenance measures specified by the manufacturer must be performed
on schedule by personnel suitably authorised. Original parts from the manufacturer
must be used; otherwise, the manufacturer's liability shall be rendered null and void.
1.3 Owner`s Responsibility
The owner is responsible for complying with the relevant national statutory provisions
governing setting up and operating technical medical equipment. (For Germany, the
Medical Products Act.) It is expressly stated that the use of unauthorised accessories
and/or unauthorised equipment combinations shall render the product liability null
and void.
The device is exclusively allowed to be used with accessories, wearing parts and dis-
posable articles that have been checked by the testing body responsible for testing the
device to ensure that they function without risk.
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Principles
2 Principles
2.1 Physical principles
The Chattanooga Intelect F-SW is a universal, compact shock wave generator that gen-
erates focused shock waves  hereinafter referred to as F-SW .
The Chattanooga Intelect F-SW may be used to perform the following treatments:
– Low-energy focused shock wave therapy with electromagnetically generated
shock waves (energy levels below 0.3 mJ/mm2)
– High-energy focused shock wave therapy with electromagnetically generated
shock waves (energy levels above 0.3 mJ/mm2)
The F-SW have a short pulse length and are concentrated on areas a few millimetres
in diameter, allowing shock waves to be applied to a tightly localised area, even in
deeper tissue layers.
2.1.1 Indications
Orthopaedics/pain therapy
– MPS (Myofascial pain syndrome)
•Treatment of deep muscle trigger points
•Treatment of superficial muscle trigger points
•Myofascial trigger points1 / Acupuncture points
•Myofascial pain / muscle pain / fascial pain2
•Chronic lower back pain, trapezius muscle, pelvic floor muscle
– Tendinopathy / tendinitis / tendonitis / tendinosis / tendon pain
•Insertion tendonitis in general
•Superficial insertion tendonitis (paratendinary area)
•Shoulder pain with or without calcifications / tendinopathy of the shoulder,
the supraspinatus or / and the rotator cuff (with and without calcification)
•Radial or ulnar humeral epicondylitis / tennis elbow / Elbow tendinopathy
•Trochanteric tendonitis / Greater trochanteric pain syndrome / trochanteric
bursitis
•Hamstring tendinopathy
•Patellar Tip Syndrome / Patellar tendonitis / iliotibial band friction syndrome /
Jumper’s Knee / Runner’s knee
•Tibial stress syndrome / tibial tendonitis
•Achillodynia / Achilles tendinitis
– Pseudarthrosis / Non-unions / Delayed unions
– Plantar Fasciitis / heel spur / heel pain
1A sound knowledge of trigger point therapy and trigger point shock wave therapy (TrST) is required for
therapeutic application of the Chattanooga Intelect F-SW in the field of trigger point shock wave thera-
py.
2Qualified training in acupuncture and acupuncture shock wave therapy (AkuST) is required for therapeu-
tic application of the Chattanooga Intelect F-SW in the field of acupuncture.
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Principles
Dermatology
Wound healing
– Ulcers
•Arterial ulcers
•Venous ulcers
•Diabetic foot
•Pressure sores, Decubital ulcers
– Burns
– Acute and chronic lesions
– Post-traumatic necrosis
– Wounds with disturbed healing
– Postsurgical wounds
– Traumatic wounds
Cellulite / lipedema / lymphedema
Urology
– CPPS (Chronic Pelvic Pain Syndrome)
•abacterial chronic prostatitis
– IPP (Induratio Penis Plastica) / PD (Peyronie’s disease)
– Vascular- / vasculogenic- / organic- erectile dysfunction
Neurology
– Spastic muscle paralyses / Spasticity / Muscle hypertonia (caused by infantile cere-
bral palsy or stroke, for example)
2.1.2 Contraindications
Low-energy shock wave therapy
Low-energy focused shock wave therapy (according to Chapter 2.1 PHYSICAL PRINCIP-
LES) is not permitted for:
– Brain or spine in the treatment area
– Malignant tumour in the treatment area
– Pregnancy
High-energy shock wave therapy
High-energy focused shock wave therapy (according to Chapter 2.1 PHYSICAL PRINCIP-
LES) is not permitted for:
– Air-filled tissue (particularly lung tissue) in the treatment area
– Brain or spine in the treatment area
– Untreated coagulopathies (haemophilia)
– Malignant tumour in the treatment area
– Epiphyseal plate areas in children
– Pregnancy
– Use of anticoagulants, especially Marcumar
– Thrombosis in the treatment area
– Cortisone therapy up to 6 weeks before first treatment
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Principles
2.1.3 Side effects
CAUTION
After treatment with the Chattanooga Intelect F-SW
side effects may occur.
►Familiarise yourself with the list of side effects.
►Inform the patient of possible side effects.
Treatment with the Chattanooga Intelect F-SW may cause the following side effects:
– Swelling, reddening, haematomas
– Petechiae
– Pain
These side effects generally abate after 5 to 10 days.
2.2 Preconditions for operation
2.2.1 Operating personnel
DANGER
If treatments and medical procedures are performed by inadequately qualified person-
nel,
this can result in damage to the health of patients and third parties as well as
fire or explosion hazards.
►Make sure that treatments and cleaning work are carried out only by qualified and
instructed healthcare professionals.
►Observe the preconditions for operation that are detailed in this chapter.
The Chattanooga Intelect F-SW is intended exclusively for use by healthcare profes-
sionals who have been trained to use the device.
It is expected that this professional has practical knowledge of medical procedures and
applications as well as of the terminology and should be experienced in treating the
indications stated in Chapter 2.1.1 INDICATIONS.
The professional must have physical and cognitive prerequisites such as vision, hearing
and reading. Furthermore, the basic functions of the upper extremities must be guar-
anteed.
The device is designed for a demographic target group between 18 and 65 years.
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Principles
2.2.2 Training of the operator
Operators of the Chattanooga Intelect F-SW must have been adequately trained in us-
ing this device. 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 :
– Operation and intended use of the device with practical exercises
– Mechanism of action and function of the device and the energies delivered by it
– All component settings
– Indications for use of the device
– Contraindications and side effects
– Explanation of the warnings in all operating modes/states
– Training on how to perform the functional checks
Further training requirements vary from country to country. It is the operator's respon-
sibility to ensure that the training meets the requirements of all applicable local laws
and regulations. Further information about training in the operation of this system can
be obtained from your dealer. You can also contact the following address directly:
DJO France SAS T: + 33 (0)5 59 52 86 90
Centre Européen de Fret F: + 33 (0)5 59 52 86 91
3 rue de Bethar E-Mail: [email protected]
64990 Mouguerre
France
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System description
3 System description
3.1 Control and functional elements
Fig. 3-1 Front view of Chattanooga Intelect F-SW
1 Monitor
2 Power indicator
3 Connection for foot switch
4 F-SW handpiece connection
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System description
Fig. 3-2 Rear view of Chattanooga Intelect F-SW
1 Potential equalisation connection
2 not used
3 Mains connection
4 Mains fuse holder
5 Mains switch
6 USB connection for USB stick, USB mouse, USB keyboard
7 Water supply connection
8 not used
9 Type Plate
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System description
3.2 F-SW handpiece and optional C-ACTOR handpiece
Focused shock waves with a short wavelength that are concentrated on a focal zone
outside the handpiece are administered over the F-SW handpiece or the C-ACTOR
handpiece into the body at the treatment zone that has been established by diagnosis.
Optical difference between F-SW and C-ACTOR : The F-SW has a blue ring around
the coupling diaphragm and the C-ACTOR has a red ring around the coupling dia-
phragm.
Fig. 3-3 F-SW handpiece or C-ACTOR handpiece
1 Trigger button
2 Clamping ring
3 Fixing screws
4 Coupling diaphragm
The coupling diaphragm is fixed by a clamping ring and 3 fixing screws. It can only be
opened from authorised personnel with special tools.
The penetration depth of the shock wave can be varied by stand-off devices.
3.3 Use of stand-off devices
The penetration depth of the shock wave can be adjusted by using different stand-off
devices.
Fig. 3-4 F-SW handpiece or C-ACTOR handpiece
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System description
Fig. 3-5 Depth of therapeutical effect of F-SW handpiece
Fig. 3-6 Depth of therapeutical effect of C-ACTOR handpiece
• Perform changing of the stand-off devices as described in chapter 6.2.1 CHANGING
THE STAND-OFF DEVICE.
The stand-off has a limited service life. It should be replaced if there are visible changes
in the material (discolouration, tarnishing, streaks, gas bubbles), deformation of the
surface in the coupling area or leaks.
The stand-off should be replaced at least every 12 months.
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