Chattanooga Intelect Focus Shockwave Therapy Device USER MANUAL

Focus Shockwave

Operating Manual

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

1

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

Contents

13 610 0002 11.2022

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

2

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

13 610 0002 11.2022

Contents

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

3

Contents

13 610 0002 11.2022

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

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.

MENUS and BUTTONS are greyed out and highlighted 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 se­rious 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.

4

13 610 0002 11.2022

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 op­erating instructions.

Safety signs and other symbols used in this manual

Symbol Notification

General warning sign

5

Type B applied part

Potential equalisation

Disconnect mains plug

Wear hearing protection

USB connection

Introduction

WEEE mark

13 610 0002 11.2022

Symbol Notification

Manufacturer

CE mark

Device serial number

CSA certification mark

It is essential to comply with the operat­ing manual

Fuse

Electromagnetic interference may occur
in the vicinity of devices marked with this
symbol.

Hot surface

Explosion

Electrical warning sign: high voltage

6

13 610 0002 11.2022

Introduction

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 nec­essary 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 com­ply with the preconditions for operation in the chapter 2.2 P

TION.

All status and error messages signaled during treatment must always be attended to
without delay.

7

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.

RECONDITIONS FOR OPERA-

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 F

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 ad­ministering 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.

UNCTIO-

General Safety Information

13 610 0002 11.2022

• 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 clean­ing and maintenance work. Do not reconnect it until everything has been com­pletely 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. Never­theless, 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

8

13 610 0002 11.2022

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 accor­ding 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.

9

– 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 C

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.

LEANING, CARE AND MAINTENANCE.

General Safety Information

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 electromag­netic 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

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.

GUIDELINES AND MANUFACTURER'S

13 610 0002 11.2022

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 environ­ment 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 distur­bance 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 F

UNCTIONAL CHECKS.

• Never cover the device when in use!

• Make absolutely sure that no liquid can seep into the system housing or hand­piece.

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 T

ONS.

ECHNICAL SPECIFICATI-

10

• 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-

• Comply with the relevant information in the operating manuals for the additional

13 610 0002 11.2022

telect F-SW or individual components.

devices.

General Safety Information

11

1.2 Manufacturer`s Responsibility

WARNING

No modifications are to be made to this device without the permission of the manu­facturer.

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 dis­posable articles that have been checked by the testing body responsible for testing the
device to ensure that they function without risk.

General Safety Information

13 610 0002 11.2022

2 Principles

2.1 Physical principles

The Chattanooga Intelect F-SW is a universal, compact shock wave generator that gen­erates 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 pain

• 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

2

12

1

2

13 610 0002 11.2022

A 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 thera­py.

Qualified training in acupuncture and acupuncture shock wave therapy (AkuST) is required for therapeu­tic application of the Chattanooga Intelect F-SW in the field of acupuncture.

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)

13

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 P

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

HYSICAL PRINCIP-

Principles

13 610 0002 11.2022

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 person­nel,

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.

14

The Chattanooga Intelect F-SW is intended exclusively for use by healthcare profes­sionals 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 I

The professional must have physical and cognitive prerequisites such as vision, hearing
and reading. Furthermore, the basic functions of the upper extremities must be guar­anteed.

The device is designed for a demographic target group between 18 and 65 years.

NDICATIONS.

13 610 0002 11.2022

Principles

2.2.2 Training of the operator

Operators of the Chattanooga Intelect F-SW must have been adequately trained in us­ing 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: [e-mail]

64990 Mouguerre

France

15

Principles

13 610 0002 11.2022

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

16

13 610 0002 11.2022

System description

17

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

System description

13 610 0002 11.2022

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 dia­phragm.

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.

18

Fig. 3-4 F-SW handpiece or C-ACTOR handpiece

13 610 0002 11.2022

System description

19

Fig. 3-5 Depth of therapeutical effect of F-SW handpiece

Fig. 3-6 Depth of therapeutical effect of C-ACTOR handpiece

System description

• 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.

13 610 0002 11.2022

4 Installation Instructions

4.1 Scope of Supply

The standard scope of supply of the Chattanooga Intelect F-SW includes the following
items:

– Chattanooga Intelect F-SW control device
– F-SW SEPIA LT handpiece
– Handpiece holder
– Mains cables
– Gel bottle
– Silicone oil bottle
– Water bag
– User manual

4.2 Unpacking

CAUTION

Equipment damage due to improper storage and transport

may affect the health of patients and users.

► Before commissioning, check that the delivered items are undamaged.

• Remove the device and accessories from the packaging container. Proceed with
extreme caution.

• Check that all items are included in the packaging container and that they are not
damaged.

• Contact your supplier or the manufacturer/dealer immediately if any delivered
items are missing or damaged.

• Retain the original packaging. It may prove useful for any later equipment trans­port.

4.3 Correct Positioning of the Device

Maintain a minimum distance between the device and the wall so that the mainsplug
can be pulled out without restrictions (disconnected from the power supplynetwork)
and the ventilation slits on the rear are not blocked.

20

13 610 0002 11.2022

Installation Instructions

4.4 Installing the handpiece holder

The handpiece holder can be mounted on the right as well as on the left side.

• Use a 2.5 mm Allen key for installation

• Screw the handpiece holder onto the right side wall of the Chattanooga Intelect
F-SW, as shown in the picture below.

Fig. 4-1 Mounted handpiece holder

1 Handpiece holder mounted to right side wall

21

4.5 Installing the holding arm

To facilitate handling of the F-SW handpiece, you can hook the handpiece onto the
optionally available holding arm.

• Use a 2.5 mm Allen key for installation.

• Screw the holder for the arm firmly onto the holes provided for it on the left of the
instrument (see picture below).

Fig. 4-2 Attachment holes for the holding arm

• Place the holding arm into the holder.

Fig. 4-3 Holding arm attached

Installation Instructions

13 610 0002 11.2022

4.6 Connecting the electrical power supply

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.

• Connect the mains cable to the mains connector on the rear of the device (see F
3-2 ).

• Insert the mains cable into the electrical socket.

NOTICE

► Maintain a minimum distance between the device and the wall so that the mains

plug can be pulled out without restrictions (disconnected from the power supply
network) and the ventilation slits on the rear are not blocked.

IG.

22

13 610 0002 11.2022

Installation Instructions

4.7 Connecting Handpiece

• Connect the connector of the F-SW handpiece to the handpiece connection pro­vided on the Chattanooga Intelect F-SW and secure it using the black locking
screw. The locking screw must be tightened up to the stop until finger-tight.

Fig. 4-4 Connecting the F-SW handpiece

Fill the water circuit of the Chattanooga Intelect F-SW first when the F-SW handpiece
is first connected after delivery. The instrument will signal “water level too low” when
it is switched on.

4.8 Connecting an optional foot switch

23

• Connect the connection cable of the foot switch to the appropriate connection on
the front side of the instrument.

The foot switch is protected against ingress of water according to classification IPX8
as per IEC 60529.

4.9 Potential equalisation connector

The Chattanooga Intelect F-SW features a potential equalisation connection.

• Connect one end of the potential equalisation cable to the PE connection on the
Chattanooga Intelect F-SW and the other end to your PE connection.

CAUTION

Risk of

electrical hazard.

► Always connect the potential equalisation connector in accordance with national

guidelines.

4.10 USB connection

The USB connection acts as an interface for data input and output.

• Connect if required

– a USB memory stick which supports the USB V1.1 protocol
– a USB mouse
– a USB keyboard.

Installation Instructions

13 610 0002 11.2022

The connected instruments must be approved as medical products in accordance with
IEC 60601.

CAUTION

Misuse of the USB connector may cause

malfunction of or damage to the device.

► The use of USB connector not authorized by the manufacturer is not permitted.
► Do not connect any wireless technology such as bluetooth and do not connect any

devices for battery charging.

4.11 Transport

NOTICE

The side walls of the device can be bent if it is not transported correctly.

Defect of the touchscreen or other components!

► DO NOT carry the device by means of mounted accessory parts (e.g. F-SW plug).

Make sure that your hands are dry and free of grease.

• Dismount the handpiece holder before transporting the device.

• To transport the instrument, grip the indentations on the side of the housing as
shown in the picture below (1) and lift it carefully.

Fig. 4-5 Transporting the device

• Set the device slantly down in order to avoid squeezing the fingers.

4.12 Compatibility

The Chattanooga Intelect F-SW is allowed to be operated with the following accesso­ries:

24

Handpiece F-SW SEPIA LT Art no. 19000

Handpiece C-ACTOR SEPIA LT Art. no. 29204.0001

Foot switch

13 610 0002 11.2022

Installation Instructions

5 Operation

The Chattanooga Intelect F-SW is operated using a colour TFT LCD monitor with touch
screen function and a graphical user interface.

5.1 Graphical user interface

The user interface of the Chattanooga Intelect F-SW is divided into various areas for
displaying different information. The individual controls are arranged in function
groups (see picture below):

25

Fig. 5-1 Controls

1 Top navigation bar
2 Top navigation bar
3 Top navigation bar
4 Status bar
5 Selection area
6 Bottom navigation bar
7 Bottom navigation bar
8 Bottom navigation bar
9 Parameter display (nominal and actual values)

The following functional description refers to control software version 13441.19.x.x or
later (this can be seen in the Info menu).

Navigation bars:

The top and bottom navigation bars (see F
that you can use for navigating through the menus:

IG. 5-1 CONTROLS) contain control buttons

Operation

13 610 0002 11.2022

Parameter entry screen

MENU Open the sub-menu

CONFIGURATION Jump to the LOAD CONFIGURATION sub-menu (call up saved

parameter configurations or patient records)

Main and sub-menu

BACK Step back

MENU EXIT Return to parameter entry screen

DELETE Delete configurations

SAVE Save configurations

OK Confirm entries, acknowledge messages

The arrow keys can be used for changing (increasing or
decreasing) the parameter values. If you are in a sub-menu
that contains more menu items than can be displayed in
the top part of the display, you can use the arrow keys to
scroll to the bottom of the list (page up/down).

Press the date key on the parameter input page to open
the INFO window.

Status bar:

The flag on the right of the status bar displays the menu
language. Touching the flag icon takes you directly to the
LANGUAGES sub-menu where you can select a different
menu language.

A warning symbol appears at the far left of the status bar
if there is an error. Touching this symbol takes you directly
to the W
sages that are currently active.

ARNINGS sub-menu that displays all warning mes-

26

The name of the loaded configuration/patient record (* in­dication/patient name) is displayed.

Parameter display:

The treatment parameters are displayed in the parameter display field in the following
sequence:

After the first start-up of the unit as well as after operating mode change, configura­tion loading and parameter change, the display flashes and must be confirmed by
touching the display field or a parameter.

13 610 0002 11.2022

Operation

Selection area

The selection area (see picture below) of the parameter entry screen contains the nom­inal value selection fields “Energy level”, “Number of shocks” and “Frequency”

Fig. 5-2 Parameter entry screen

– When you open a menu, the name of the opened menu appears in the top line

against a dark blue background. The sub-menu items are indented.
– A sub-menu item is selected by touching the corresponding display area
– The selected sub-menu item appears against a dark blue background.
– Sub-menu items that themselves have an additional sub-menu are identified by a

green arrow to the right (F
– If there are more than 4 menu items, they can be selected using the arrow keys

(FIG. 5-3 /2). If one of the arrow keys disappears, this means no more selections

can be made in this direction.
– Once a sub-menu has been selected, it is opened using the OK button

IG. 5-3 /1).

27

Fig. 5-3 List of the sub-menu items

Operation

13 610 0002 11.2022

5.2 Function overview

Main menu 1st sub menu 2nd sub menu

Actual val. reset Info English
Save configuration Language German
Load configuration Time Spanish
Setup Touch-screen calibration Italian
Warnings Drain water French
Data transfer Fill water Portuguese
Exit user interface Bleed water circuit Russian

1) password protected

Reset water change time Polish
Set mJ/mm² - MPa Czech
Set SW number/energy Dutch
Auto-Freq. Norwegian
Warning history Swedish
Software update Danish

1)

Service

Export treatment data Hungarian
Backup settings Japanese
Restore settings

Suomi
Chinese
Turkish

Parameter entry
window

Main menu

Actual val. reset
(reset trigger counter)

Save configuration

Load configuration

Setup

Warnings

Data transfer

Exit user interface

–

Determining the treatment parameters

– Resetting the actual values in the selected operating

mode (treatment shock counter, total energy, close
patient record)

– Saving indication-specific (preceded by *) or patient-

specific treatment parameters

– Loading already stored treatment parameters, open-

ing the patient record.The keyboard window in the
2nd sub-menu enables you to make your own text en­tries. However, you can also do this by connecting a
separate USB keyboard.

See 1st sub-menu

– List of current warnings

– Export treatment data (using this sub-menu, it is pos-

sible to transfer the treatment data as files onto a USB

memory stick and open them in Excel)
– Backup settings (backup)
– Restore settings (backup)

• Closes the user interface

28

13 610 0002 11.2022

Operation

1st sub-menu

Info – Total shock count and instrument operating hours

(depending on operating mode selected)

– Total number of shocks of the respective handpiece,

data on monitoring software, operating system, hard­ware serial numbers and modification status

– Information about modules: To view serial numbers

and indexes of the modules, scroll to the second page
of the Info window by using the arrow key.

29

Warning history – List of the last 100 warning and error messages

Language – Setting leads to language submenu

Time – Setting the date and time

Touch screen calibra­tion

Drain water / fill water – The corresponding sequences for emptying or filling

Bleed water circuit – The corresponding sequences for bleeding the water

Reset water change
time

Software update – Transferring new software from the USB memory stick

Set mJ/mm2 - MPa – Changeover between mJ/mm

Set SW number /
energy

Auto-Freq. – Selecting an energy level causes the instrument to

– This function makes it possible to recalibrate the touch

screen, i.e. for correct recognition of the touch coor­dinates

the water circuit are activated.

circuit are activated.

– Reset the reminder function for the water renewal

2

- MPa for displayed

energy

– Changeover between shock number and total energy

nominal value specification

switch to the maximum frequency automatically.
If this function is not activated, the selected frequency
is not exceeded when the energy level is changed.
However, it is adapted according to the energy level.

Operation

13 610 0002 11.2022

5.3 Starting the instrument

• Switch the control device on or off at the mains switch on the rear (see FIG. 3-2 ).

The device is operated via the touchscreen display.

WARNING

If a control panel display or a touchscreen / operating monitor should fail, the safety
of the patient can no longer be ensured

Risk of patients being placed under strain due to ineffective treatment or even
impairments to their health!

► Abort the treatment.
► Inform your service centre.

Filling the water circuit:

The first time the instrument is switched on and each time the F-SW handpiece is re­placed, the instrument will display the message “Fill water circuit”.

• Touch OK to confirm the message.

The device is operated via the touchscreen display.

 The instructions on the display will guide you through the steps required:

– Connect the full water bag
– Filling the water circuit
– Remove the water bag

A detailed description can be found in Chapter 6.3.2 F

ILLING THE WATER CIRCUIT

Warm-up phase

Once a day, the Chattanooga Intelect F-SW starts a warm-up phase lasting about 3
minutes, the progress of which is shown in the progress indicator.
The water circuit is bled.

• Check that the F-SW handpiece is correctly positioned in the holder and that no
stand-off is fitted.

Fig. 5-4 Warm-up phase

No F-SW shock triggering is possible during the warm-up phase. All other functions
of the instrument can be used, however.

30

13 610 0002 11.2022

Operation

High voltage test

A high voltage test is performed once a day when the Chattanooga Intelect F-SW is
switched on for the first time. This test takes place after the warm-up phase.

• When prompted to do so, briefly touch the trigger button on the F-SW handpiece
or the foot switch.

Fig. 5-5 High voltage test

5.4 Setting treatment parameters

31

Once the unit has been started, the display automatically shows the last setting.

• Touch the flashing parameter display or one of the parameter selection fields to
confirm the operating mode.

• Select the line of the parameter that you would like to change.

• Set the value using the arrow keys.

• Release shocks.

 The treatment will be carried out with the displayed values.

The maximum possible frequency for generating shock waves depends on the selected
energy level. When increasing the energy level, the shock wave frequency is reduced
if necessary (see Chapter 5.1 GRAPHICAL USER INTERFACE).

The selection of energy levels is based on the medical opinion of the healthcare pro­fessional administering treatment. The treatment must never be allowed to cause the
patient to experience any excessive amount of pain.

Operation

13 610 0002 11.2022

F-SW

Energy flux density in mJ/mm

2

0.55 3 Hz

0.50 3 Hz

0.45 3 Hz

0.40 3 Hz

0.35 4 Hz

0.30 4 Hz

0.25 4 Hz

0.20 5 Hz

0.15 6 Hz

0.12 6 Hz

0.10 6 Hz

0.07 6 Hz

0.05 7 Hz

0.03 8 Hz

0.02 8 Hz

0.01 8 Hz

Tab. 5-1 Treatment parameters in F-SW mode

Maximum frequency Handpiece

C-Actor

Energy flux density in mJ/mm

2

1.24 3 Hz

1.14 3 Hz

1.02 3 Hz

0.88 3 Hz

0.76 4 Hz

0.69 4 Hz

0.56 4 Hz

0.45 5 Hz

0.33 6 Hz

0.25 6 Hz

0.13 7 Hz

0.08 8 Hz

0.05 8 Hz

0.03 8 Hz

Tab. 5-2 Treatment parameters in C-ACTOR mode

Maximum frequency Handpiece

32

13 610 0002 11.2022

Operation

5.5 F-SW energy display task

To make sure that the energy level is correctly displayed at all times, the system inclu­des a self monitoring function. Therefore, during shockwave release the system con­stantly compares the nominal energy value with the actual energy value. If these values
do not match the energy level is displayed in grey and turns white as soon as the re­quired set value is reached.

Fig. 5-6 Energy level not yet reached

If the difference persists shock wave release is disabled and an error message is displa­yed.

33

Fig. 5-7 Error: Energy level not set

In case the warning appears, you can acknowledge it by touching OK . Inform your
service centre if the fault continues.

Operation

13 610 0002 11.2022

5.6 Store treatment notes

• Touch the MENU button.

• Select the S

AVE CONFIGURATION function as shown in the picture below to save the

current setting of the treatment parameters (FIG. 5-8 STORING THE TREATMENT PA-

RAMETERS/1).

• Touch the OK button.

Fig. 5-8 Storing the treatment parameters

A list with a total of 100 memory locations appears on the touch screen display in
the SAVE CONFIGURATION sub-menu. The system automatically stores the new pa­rameter configurations at the end of the list with the corresponding creation date
and time as shown in the picture below.

• Touch the S

CONFIGURATION

AVE key to save the current setting (see picture below FIG. 5-9 SAVE

SUB-MENU/1).

Fig. 5-9 Save configuration sub-menu

If you select a field that is already occupied, you are asked if you want to overwrite the
content. Confirm by touching OK or revoke your selection by touching the BACK key.

• To rename the configuration, touch the button again that has already been se­lected. This activates the keyboard window.

34

13 610 0002 11.2022

Operation

35

Fig. 5-10 Keyboard window

 You can save your parameter setting either as an indication or under a pa-

tient’s name.

• To save the parameters as an indication, place an “*” before the name of the in­dication or leave it in place (“*Indication name”).

 The saved and selected or loaded indication appears in the status bar. This dis-

play disappears if a parameter is subsequently changed

• To save the parameters for a particular patient (patient record), store the setting
directly under the name of the patient (“last name, first name”).

 The configuration stored for a patient name is also displayed in the status bar.

The display of patients’ names does not disappear when the parameters are
changed. All parameter changes are logged in a table.

The patient record is closed when:
– a new patient record is called up (loaded),
– an indication is loaded,
– a parameter reset is performed (actual value),
– the unit is switched off.

• Confirm each of your entries by touching the OK button.

• Delete a stored configuration that is no longer required using the D

IG. 5-9 SAVE CONFIGURATION SUB-MENU/3).

(F

 Up to 1000 treatments can be stored.

ELETE button

Operation

13 610 0002 11.2022

5.7 Loading treatment parameters

The alphabetical list of treatment parameters that have already been stored or of the
patient record can be opened either directly from the parameter entry screen or from
the main menu screen

• If you are in the parameter entry screen, touch the button C

(FIG. 5-6 ENERGY LEVEL NOT YET REACHED)

• If you are in the main menu, select the LOAD CONFIGURATION function from the list
(FIG. 5-8 STORING THE TREATMENT PARAMETERS/2).

 The “Load configuration” menu contains the following indication groups:

In-house applications

Orthopaedic indications

Urological indications

Aesthetics indications

Wound healing

ONFIGURATION .

5.7.1 Pre-programmed indications from the manufacturer

• Touch the button on which the required application area is displayed (see picture
below).

• Touch the OK button.

36

Fig. 5-11 Loading a configuration I

• Select the required indication

Fig. 5-12 Loading a configuration II

• Prior to loading an indication, you can view further information on the selected in-

13 610 0002 11.2022

dication.

Operation

• To accomplish this, touch NOTE .

 The treatment notes will be displayed.

• To load the indication, touch BACK to return to the previous screen.

• Touch L

 The indication has been loaded successfully when the loaded indication is dis-

played on the grey status bar (see picture below).

Fig. 5-13 Loaded indication

• To review the treatment notes, touch the name of the indication on the grey status
bar.

The loaded indication is exited by

– Opening a new indication
– Changing a treatment parameter range
– Switching off the instrument.

OAD .

37

5.7.2 In-house applications

• Touch the IN-HOUSE APPLICATION button (see picture below).

• Touch OK .

Fig. 5-14 In-house applications

• Touch the button for the indication required (see picture below).

Operation

13 610 0002 11.2022

Fig. 5-15 In-house indications

If additional information for the selected indication has been saved, this can be ac­cessed by touching NOTE .

• To add additional information, touch the text box (see picture below) to display
the on-screen keyboard.

Fig. 5-16 Text box for treatment notes

• Save the text by touching OK .

• Touch the BACK button to view the list of in-house applications.

• Touch the L

 The highlighted indication will be loaded. The indication has been loaded suc-

cessfully when the loaded indication is displayed on the grey status bar.

• To review the treatment notes, touch the grey status bar.

The loaded indication is exited by
– Opening a new indication
– Changing a treatment parameter range
– Switching off the instrument

OAD button.

38

13 610 0002 11.2022

Operation

5.8 Loading patient data

• Touch the IN-HOUSE APPLICATIONS button (see picture below).

• Touch OK .

• Touch the button on which the required patient name is displayed.

Fig. 5-17 Loading a patient record

• Touch the PROTOCOL button.

 The patient record will be displayed.

39

Fig. 5-18 Patient record - treatment details

A patient record consists of treatment details and a table of treatment param­eters that is created by the instrument automatically.
Each time a patient is accessed, a new treatment with the current date is saved
to his or her patient record.

Fig. 5-19 Treatment parameters

Operation

13 610 0002 11.2022

• To add additional treatment details, touch the text field to display the on-screen
keyboard.

• Save the text by touching OK .

• Touch the B

• Touch the LOAD button.

 The treatment parameters for the highlighted patient will be loaded.

The treatment parameters have been loaded successfully when the patient’s
name is displayed on the grey status bar on the protocol screen.

• To review the patient record, touch the grey status bar.

 The patient record is closed by

– Opening a new patient record or indication
– Resetting the shock counter
– Switching off the instrument.

ACK button to view the list of in-house applications.

5.9 Visual analogue scale (VAS)

The visual analogue scale in the patient record can be used for assessing the progress
of the therapy. The VAS measures the patient’s subjective pain sensation on a scale
from 0 to 10, within which the patient can classify his or her pain intensity. The starting
point (0) stands for “no pain” while the ultimate point (10) stands for the “worst imag­inable pain”. In each therapy session, the patient is asked once again to assign a value
to the pain he/she has felt since the last treatment. The reduction in VAS values over
the course of the therapy gives an indication of the success of the treatment.

• Touch and drag the arrow to move it to the point on the scale (see picture below)
where the patient has assigned his or her pain intensity.

• Touch OK to fix the arrow.

40

Fig. 5-20 Setting the VAS value

13 610 0002 11.2022

 The arrow can then no longer be moved and the set value appears at the left-

hand edge of the VAS scale.

Fig. 5-21 Set VAS value

Operation

5.10 Data transfer

Exporting treatment data

Using this function, treatment data can be exported onto a USB memory stick in a for­mat that can be opened in Excel. Also, operating data can be saved (backup) or re­stored following a repair or if the instrument is replaced.

• Ensure that your USB memory stick supports the USB V1.1 protocol. You can order
a validated USB stick from your dealer

• Load a patient-specific parameter record.

• Select the DATA TRANSFER / EXPORT TREATMENT DATA function in the 1st sub-menu
(see picture below).

Fig. 5-22 Data export

41

• Connect the memory stick to the USB port as soon as you are prompted to do so
(see picture below) and confirm by touching OK .

Fig. 5-23 Data export II

Operation

13 610 0002 11.2022

Fig. 5-24 Establishing the USB connection

 The USB connection is established.

The data is transferred once the USB connection has been established. The ex­port file name of the patient record is protocol_name.csv.
All data is exported if no patient record or no indication has been opened.
The export file name of the record data is protocol_DateTime.csv

• Wait until the “Export completed” message appears on the display (see picture be­low), then remove the memory stick.

Fig. 5-25 Data export complete

Backing up the settings

42

Using the B
indication data onto a USB memory stick as a backup (in a file format that can only be
read by the instrument).

• Select the DATA TRANSFER / BACKUP SETTINGS function in the 1st sub-menu (FIG. 5-

• Connect the memory stick to the USB connector as soon as you are prompted to

• Remove the USB memory stick.

13 610 0002 11.2022

ACKUP SETTINGS function, you can save configuration settings, patient and

22 /2).

do so and confirm by touching OK .

 After the USB connection has been established, the data backup is performed

and the text window shows the name of the backup file.

Operation

Restoring the settings

The system is restored to the data status of the last backup using the RESTORE SETTINGS
function.

• Select the D
22 /3).

• Connect the memory stick with the backup file to the USB port as soon as you are
prompted to do so and confirm by touching OK .

 The backup file is loaded onto the system once the USB connection has been

established. You are prompted to restart the system when the loading proce­dure has finished.

• Remove the USB stick and restart the instrument.

ATA TRANSFER / RESTORE SETTINGS function in the 1st sub-menu (FIG. 5-

5.11 Resetting the treatment shock counter

• To reset the applied shock counter to “0”, select the ACT. VAL. RESET menu option
(see picture below) or touch the counter display.

43

Fig. 5-26 Resetting the treatment shock counter

Operation

13 610 0002 11.2022

5.12 "Autofrequency" function

If the autofrequency function is activated, the frequency is automatically increased to
the maximum possible setting when the energy level is reduced in F-SW mode (see
chapter 5.4 S

MODE).

• Select the F-SW operating mode if this function should be deactivated.

• Press the AUTOFREQ. [ON] item in the SETUP menu (see Fig. FIG. 5-27 /1) to deac­tivate the autofrequency function.

Fig. 5-27 AUTOFREQ. [ON] item

 The instrument automatically changes to AUTOFREQ. [OFF] status (see FIG. 5-28

ETTING TREATMENT PARAMETERS, TAB. 5-1 TREATMENT PARAMETERS IN F-SW

/1)

Fig. 5-28 Autofrequency function is deactivated

Now, the selected frequency remains the same even if the energy level is
changed.

• Touch the EXIT button to return to the main menu.

This frequency can be reduced manually.

5.13 Start-up

• Switch the instrument on as described in chapter 5.3 STARTING THE INSTRUMENT.

CAUTION

Equipment damage due to improper storage and transport

may affect the health of patients and users.

► Before commissioning, check that the delivered items are undamaged.

44

13 610 0002 11.2022

Operation

• Check that there are no bubbles in the handpiece.

If air bubbles are visible under the coupling diaphragm, proceed as follows:

• Position the handpiece in the handpiece holder.

 This ensures that air bubbles will always be sucked out of the handpiece auto-

matically.

• Leave the handpiece in this position for approx. 3 minutes until the suction proce­dure has finished.

45

• To work in F-SW mode, set the energy of the shocks to an initial value of 0.1 mJ/
mm

2

.

The maximum energy level corresponds to an energy flux density of 0.55 mJ/mm

• Optional: To work in C-ACTOR mode, set the energy of the shocks to an initial
value of 0.33 mJ/mm2.

The maximum energy level corresponds to an energy flux density of 1.24 mJ/mm

The highest permitted frequency is always set when an energy level is selected (see
chapter 5.7 LOADING TREATMENT PARAMETERS). This frequency can be reduced manu­ally.

• Press the trigger button.

The trigger button functions as an on/off switch when it is pressed briefly (< 1.5 s).
Pressing it for longer (> 1.5 s) causes it to function as a tip switch, i.e. the shocks will
continue until the button is released.

If a nominal shock wave value of less than 1000 shock waves is selected (e.g. 400
shock waves), a window with the following text appears after the nominal value has
been reached: “Number/energy set value reached”.
The message can be acknowledged by touching the OK button or the corresponding
trigger button. Further treatment is possible.

This message is activated again as soon as a multiple of the set nominal value is
reached (e.g. 800 shock waves, 1200 shock waves, etc.).

If a nominal value above 1000 shock waves is selected (e.g. 1700 shock waves), the
instrument automatically triggers a safety stop at 1000 shock waves (see picture be­low). The next stop occurs when the set nominal value is reached. Following this, the
counter continues to stop at intervals of 1000 (e.g. 2700, 3700, etc.).

2

.

2

.

Operation

If the nominal value is 0 (displayed as “ - ”), the stop only occurs at 19,999 shocks.

Fig. 5-29 Safety stop

13 610 0002 11.2022

5.14 Functional checks

Perform the following functional checks after the system has been installed:

• Check the control unit and handpieces for damage.

• Start the Chattanooga Intelect F-SW (see chapter 5.13 S

• Set the energy level in F-SW mode to 0.2 mJ/mm2.

Optional: Set the energy level in C-ACTOR mode to 0,69 mJ/mm2.

• Reset the actual number of shocks on the parameter display of the control panel.
See chaper 5.11 RESETTING THE TREATMENT SHOCK COUNTER

• Release shocks with a shock frequency of 4 Hz.

• Release shocks by means of the foot switch, if used

• Check that the triggered shocks are correctly counted on the treatment shock
counter.

If necessary, the functional capability of the F-SW handpiece can be checked with the
aid of special Colour sensitive pressure sensors (see chapter 8 ACCESSORIES).

5.15 Standard settings

• Before each treatment, make sure that the shock counter is set to ‘0’.

Set the nominal value counter to the required value. The "-" symbol appears if zero is
selected. The instrument then operates without a nominal value specification.

• Start the F-SW treatment at a energy level of 0.1 mJ/mm

• Start the C-ACTOR treatment at a energy level of 0.33 mJ/mm2 and a frequency
of 6 Hz.

TART-UP).

2

and a frequency of 6 Hz.

46

5.16 Treatment

Safety information

Before using the device, the user must make sure it is functioning safely and in proper
condition.

• Each time after the device has been transported, make sure that all functional
checks have been performed on the device before you start treatment. Read about
this in chapter 5.14 F

• Read chapter 1 GENERAL SAFETY INFORMATION before beginning treatment.

CAUTION

If the handpiece is not positioned correctly, there is an

impairment to health due to ineffective treatment!

► Define the treatment zone and make sure that the handpiece position always cor-

responds to the treatment zone.

► Make sure that the treatment is only administered by users who meet the condi-

tions in Chapter 2.2 PRECONDITIONS FOR OPERATION.

UNCTIONAL CHECKS.

13 610 0002 11.2022

Operation

For safety reasons, using the device for applications other than those specified in chap­ter 1 GENERAL SAFETY INFORMATION is not permitted!

• Apply a sufficient amount of coupling gel to the patient’s skin in the treatment
area and to the F-SW coupling diaphragm or the stand off device.

CAUTION

Cleaning and maintenance work during treatment may lead

to injuries to patients and therapists.

► No cleaning and maintenance work is to be carried out while the device is being

used on the patient.

• All status and error messages signaled during treatment must always be attended
to without delay!

5.17 Switching Off the Device

• Switch off the Chattanooga Intelect F-SW using the main switch.

• If the system is transported or is unused for a longer period of time, always switch
it off completely, using the button on the backside.

47

Operation

13 610 0002 11.2022

6 Cleaning, care and maintenance

CAUTION

Injuries to patients and people administering the treatment

► No cleaning and maintenance work is to be carried out while the device is being

used on the patient.

6.1 Cleaning the device

Regular cleaning ensures perfect hygiene and operation of the Chattanooga Intelect
F-SW.

The frequency of complete exterior cleaning depends on the frequency of use and
what the device is used for.

DANGER

Electrical hazard

Disconnect the device from the mains before starting any cleaning, mainte­nance or overhaul work.

► Disconnect the mains plug.

DANGER

Cleaning agents and disinfectants

can form an explosive atmosphere.

► Disconnect the handpiece from the control unit before starting any cleaning or

maintenance work.

► Make sure that treatments and cleaning work are carried out only by qualified and

instructed healthcare professionals.

WARNING

On contact with contaminated surfaces

there is a risk of transmission of infection.

► Clean all parts which come into contact with the patient before and after each

treatment.

48

13 610 0002 11.2022

Cleaning, care and maintenance

• Wipe down the device parts with a damp cloth.

For cleaning, use a lukewarm, diluted solution of non-vegetable soapy water.

DANGER

► It is essential that no fluid be permitted to penetrate either the device or its hoses.

Ventilation slots

• Keep the ventilation slits clear.

Monitor and Touch Screen

Only a cloth moistened with water, without any cleaning additives, may be used to
clean the LC displays.

• Wipe down the screen.

• Rub the screen dry with a cotton cloth.

• Immediately remove contamination (e.g. contrast agent spots).

6.2 Cleaning the handpieces

6.2.1 Changing the stand-off device

• Stand-off devices must be changed for treatment and service reasons. Check be­fore treatment that the stand-off device is tightened firmly.

49

1 To attach the stand-off device

2 To release the stand-off device

3 Stand-off

4 Closing ring

Fig. 6-1 Attaching the stand-off device

• To release: Press the closing ring towards the rear and then unscrew it.

Fig. 6-2 Releasing the closing ring

Cleaning, care and maintenance

13 610 0002 11.2022

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 device should be replaced at least every 12 months.

1 stand-off I

2 stand-off II

3 anatomic stand-off (optional)

Fig. 6-3 Stand-offs without ring

• Fit a clean stand-off into the closing ring.

• Apply a drop of silicone oil to the coupling diaphragm as a coupling medium.

• To attach: Screw the closing ring towards the front and tighten it firmly with your
hand.

6.2.2 Reprocessing the handpiece and the stand-off devices

After each therapy session all parts of the handpiece which have been in contact with
the patient must be thoroughly cleaned and disinfected for further treatments. There­fore the instruction must be strictly followed in order to avoid damage to the parts and
prevent malfunctions.

Make sure that the following means and tools are available for cleaning and disinfec­tion:

– clean, soft and lint-free cleaning tissues
– cleaning agent
– alcohol-based surface disinfectant.

50

6.2.2.1 Cleaning

• Screw off the stand-off device from the handpiece as described in chapter 6.2.1
CHANGING THE STAND-OFF DEVICE.

• Clean the handpiece and the stand-off devices of coupling gel, residual oil and
other water-soluble contaminants using a damp tissue.

6.2.2.2 Disinfection

• Disinfect the handpiece and the stand-off devices with a alcohol-based surface dis­infectant.

• Spray the handpiece and the stand-off devices with a disinfectant spray.

• Wipe the handpiece and the stand-off devices with a damp soft tissue.

• Dry the handpiece and the stand-off devices with a dry, absorbent soft and lint­free tissue.

13 610 0002 11.2022

Cleaning, care and maintenance

Coupling diaphragm and stand-off devices must be protected against mechanical
damage. Do not use metallic or sharp objects for cleaning.

NOTICE

Cleaning agents and disinfectants

may impair the characteristics of the coupling diaphragm.

► Do not use vegetable-based soap solutions of vegetable oils.
► Do not use agents containing any of the following:

– Aniline
– Dimethylformamide
– Ethyl acetate
– Methylene chloride
– N-methylpyrrolidone
– Nitric acid, 20 percent
– Hydrochloric acid, 20 percent
– Sulphuric acid, 20 percent
– Trichlorethylene
– Tetrahydrofurane
– Toluene

51

The constituents listed here are non-binding examples. No claims are made regarding
the completeness of the list.

6.2.3 Cleaning the optional foot switch

• Clean the foot switch with soapy water or a mild cleaning agent.

The foot switch is protected against ingress of water according to classification IPX8
as per IEC 60529.

Cleaning, care and maintenance

13 610 0002 11.2022

6.3 Water renewal

The water in the cooling circuit of the Chattanooga Intelect F-SW should be renewed
every 6 months or so. The instrument automatically displays a message to this effect
when it is switched on if the water renewal is due (see the picture below).

Fig. 6-4 Prompt for water renewal

• Touch the OK button to acknowledge this message.

 The message no longer appears once the water has been renewed.

6.3.1 Draining the water circuit

The water circuit must be drained if the instrument will not be used for several weeks.

• Make sure that the instrument is standing on a smooth surface.

• Activate DRAIN WATER operating mode in the SETUP menu (see picture below).

Fig. 6-5 Water renewal

• Connect the water bag to the Chattanooga Intelect F-SW and put it on the floor
as soon as the message appears.

52

13 610 0002 11.2022

Cleaning, care and maintenance

53

Fig. 6-6 Draining the water circuit I

 The “Please wait” message and a progress indicator appear on the display.

• Allow the remainder of the water to drain out of the handpiece by holding the F­SW handpiece vertically above the instrument as soon as you are prompted to do
so. Make sure that the coupling diaphragm of the handpiece is pointing upwards.

Fig. 6-7 Draining the water circuit II

 The “Please wait” message and a progress indicator appear on the display.

• Wait until the instrument is ready. The display shows when the water circuit is
empty.

Cleaning, care and maintenance

Fig. 6-8 Draining the water circuit III

• Open the lock on the tube connection and pull the tube out of the tube connec­tor.

• Remove the full water bag and dispose of the contents.

13 610 0002 11.2022

6.3.2 Filling the water circuit

• Make sure that the instrument is standing on a smooth, horizontal surface.

• Use only deionised water (in compliance with VDE 0510, e.g. water for batteries
or clothing irons) to rinse or fill the water bag.

• Fill the water bag to the brim ( minimum 800ml or 27oz.). In order to add the max­imum amount of water to the water bag, place the bag on the palm of your hand
and squeeze it gently at the sides whilst filling.

Fig. 6-9 Filling the water bag

Do not use water that has been distilled more than once!

After the water bag has been filled, there should be as few bubbles as possible in
the connection tube.

• Hold the water bag up with the connection tube hanging vertically downwards to
let the air rise automatically into the water bag.

• Place the F-SW handpiece into the F-SW handpiece holder so that any air bubbles
that form will be immediately sucked up by the bubble trap.

Fig. 6-10 Handpiece in holder

• Activate FILL WATER operating mode in the SETUP menu.

54

13 610 0002 11.2022

Cleaning, care and maintenance

55

Fig. 6-11 Filling the water circuit I

• Connect the water bag to the water tube connection on the rear of the instru­ment as soon as the message appears.

• At the same time, hold the water bag at least 70 cm / 28" above the water tube
connection, so the water can flow out optimally. Hook the bag onto an infusion
stand if necessary.

• Touch OK .

Cleaning, care and maintenance

Fig. 6-12 Filling position and progress display

 A progress display with the message “Please wait” appears on the display.

• As soon as the water circuit has been filled, the instrument prompts you to remove
the water bag (see picture below). There may be water left in the bag.

13 610 0002 11.2022

Fig. 6-13 Filling the water circuit II

• Push the lock on the tube connector and pull the tube out of the connection.

• Confirm by touching OK .

 There might be air bubbles in the system after the water has been changed.

The instrument needs about 15 minutes to remove these air bubbles. A prog­ress bar will be displayed (see FIG. 6-14 ).

Fig. 6-14 Bleeding the water circuit

• Wait for the message to disappear, then return to the parameter entry screen by
touching the MENU EXIT button.

• Check that there are no bubbles under the coupling diaphragm of the F-SW hand­piece. If bubbles are present, briefly hold the handpiece pointing downwards in a
vertical position. The air bubbles will then be automatically sucked in by the bubble
trap.

56

6.3.3 Bleeding the water circuit

• Select BLEED WATER CIRCUIT from the SETUP menu (see FIG. 6-6 DRAINING THE WA-

TER CIRCUIT I, /3).

 A progress bar will be displayed.

• Wait for the message to disappear, then return to the parameter entry screen by
touching the M

• Check that there are no bubbles under the coupling diaphragm of the F-SW hand­piece. If bubbles are present, briefly hold the handpiece pointing downwards in a
vertical position. The air bubbles will then be automatically sucked in by the bubble
trap.

13 610 0002 11.2022

ENU EXIT button.

Cleaning, care and maintenance

6.3.4 Resetting the water renewal time

2

1

Every six months, the instrument prompts you to renew the water; the prompt does
not disappear permanently until the water has been renewed.The RESET WATER CHANGE

TIME

function can be selected to cancel this reminder function or to adapt it to a new

date setting.

57

• Activate R

ESET WATER CHANGE TIME operating mode in the SETUP menu.

 The time when the water change time reminder is triggered is automatically

moved forwards by six months. A window showing the new date of water re­newal appears briefly on the display.

• Press the EXIT button to open the parameter entry screen.

Failure to renew the water regularly may shorten the service life of the instrument.

6.4 Mains fuse replacement

The mains fuse holder is located on the rear of the Chattanooga Intelect F-SW be­tween the mains connection and the ON/OFF switch.

• Push the clip of the mains fuse holder to the right and take the holder off the hous­ing.

Fig. 6-15 Mains fuse holder

Fig. 6-16 Fuse replacement

1 Fuse holder
2 Fuse

Cleaning, care and maintenance

• Pull the old fuses out of the mains fuse holder.

• Replace the fuses (T5AH / 250 VAC).

• Push the mains fuse holder back into the opening until it engages.

13 610 0002 11.2022

6.5 Cybersecurity measures

Like all computer-based systems, the system might be exposed to cybersecurity
threats.

Safety critical core functions of the device, such as shock wave release are decoupled
from software and can be activated by hardware switches only.

In order to minimize the possibility of cyber attacks, it is the user’s responsibility to
make sure that the following protection measures are followed.

1) The product may only be installed, commissioned, maintained, updated and
operated by authorised personnel. These persons are to be employees of the
manufacturer or other authorised third parties.

2) Software updates distributed by the manufacturer (functional or safety-relevant)
must be installed via the enclosed Technical Product Information (TPI). Subsequent
feedback to the manufacturer or its service partner is required.

3) A regular data backup of the system must be carried out. Depending on the num­ber of patients, this should be done daily, but at least weekly.

4) Software that is not distributed by the manufacturer or one of its service partners
may not be used with the product.

5) A virus scan of the USB sticks used must be carried out to check whether they are
free of viruses, malware or dangerous software.

6) All service and maintenance areas are password protected. Such access can only
be granted by the manufacturer to authorized service personnel.

Contact the manufacturer or the authorised customer service in the following
cases:

– In case the product shows unknown or not logical behavior, such as a slow reac-

tion of the software or if the password is not accepted, access to the databases is
not possible or it switches to a wrong user interface dialogue.

– In case you face issues with the IT security of this product.
– In case you lost your password, login credentials or user access.

58

6.6 Software updates

For software update, please contact your local dealer.

6.7 Maintenance and safety checks

Preventive maintenance is not necessarily required. However, regular maintenance
may help to identify possible defects at an early stage and thus increase the safety and
service life of the device.

Maintenance services can be ordered from our regional representatives in your area.

We recommend that functional and safety checks be performed at least once a year
(see Chapter 5.14 FUNCTIONAL CHECKS), in addition to the national accident prevention
regulations and test and inspection intervals prescribed for medical devices that are re­quired to be observed.

The following checks should be performed to ensure that the Chattanooga Intelect F­SW operates safely:

1. Earth leakage current test from the chassis in accordance with national regula­tions.

2. Earth impedance test (including housing and with mains cable) in accordance with
national regulations.

13 610 0002 11.2022

Cleaning, care and maintenance

3. Test of essential performance.

For further details on content and performance of the safety checks please contact
your local dealer.

6.8 Repair

Repair work on defective devices must only be carried out by personnel suitably autho­rised by the manufacturer. Only original parts from the manufacturer may be used for
this purpose.
The suitably authorised personnel can be representatives or its agencies and dealers.

6.9 Disposal

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 the service life of the device, dispose of the Chattanooga Intelect
F-SW as waste electronic equipment.

• Please contact the manufacturer or distributing company in relation to this.

• When disposing of wear parts, you must comply with the relevant national dispos­al regulations.

59

• Comply with the relevant information in the operating manuals for the additional
devices.

6.10 Service life

The average expected service life (MTTF) in accordance with IEC 60601-1:2005 +
A1:2012 / EN 60601-1:2006 + A1:2013 is

– 15,000 operating hours for the Chattanooga Intelect F-SW
– 5 million shocks for the F-SW SEPIA LT handpiece
– 5 million shocks for the C-ACTOR SEPIA LT handpiece

The coil is a wear part. After 2 million shocks the coil needs to be exchanged to avoid
secondary damages on the handpiece and on the control device.

Exceeding the service life can be expected to result in a failure of the device and acces­sories. This also applies to handpieces.No warranty claims shall be accepted beyond
the information given in chapter 10 W

ARRANTY AND SERVICE.

Cleaning, care and maintenance

13 610 0002 11.2022

7 Status messages, error messages / fault displays

7.1 Status messages

CAUTION

Malfunction of the device or its components.

Various injuries are possible!

► Immediately comply with all status and error messages which appear during the

treatment.

Fault description Possible cause and remedy

Specified number of shock waves
reached

Shock wave safety stop Acknowledge message, further treat-

F-SW : load test unsuccessful Restart the instrument and repeat the

F-SW : charging timeout Acknowledge message.

F-SW : water temperature too high Acknowledge message,

F-SW : water temperature too low Acknowledge message,further treat-

F-SW : water level too low Fill the water circuit (see chapter 6.3.2

F-SW : water circuit fault Pump defect

F-SW : pump temperature too high Acknowledge message,

F-SW : therapy head overtemperature Acknowledge message,

F-SW : water temperature sensor failure Restart the instrument.

Acknowledge message, further treat­ment is possible.

ment is possible.

test.
Do not continue to use the instrument if
the fault continues.
Notify your Service centre.

Inform your Service centre if the fault
continues.

further treatment is possible once the
water temperature has returned to per­mitted values.

ment is possible once the water tempera­ture has returned to permitted values.

ILLING THE WATER CIRCUIT)

F

Treatment is not possible.
Bleed the water circuit (see chapter 6.3.3
BLEEDING THE WATER CIRCUIT).
Inform your Service centre if the fault
continues.

further treatment is possible once the
pump temperature has returned to per­mitted values.

further treatment is possible once the
therapy head temperature has returned
to permitted values.

Inform your Service centre if the fault
continues.

60

13 610 0002 11.2022

Status messages, error messages / fault

Fault description Possible cause and remedy

Shock wave limit for current handpiece
reached

F-SW : charging unit not ready Acknowledge message.

USB stick was not recognised Remove the USB stick, then switch off

Water amount insufficient, please check
supply

Water pump malfunction Restart the instrument. Drain and re-fill

Water pressure low Restart the instrument. Call your Service

Shock wave limit for current handpiece
reached.
Contact your service center for coil re­placement.

Call your Service centre if the fault con­tinues after a reset.

and restart the instrument.
Reinsert the USB stick.
Check that there is software on the USB
stick.
If the fault persists, check that the USB
stick supports the USB V1.1 protocol.
If it does not, replace the USB stick.

Fill the water bag and check whether wa­ter is flowing into the water circuit.
If the fault persists, inform your Service
centre.

water.
Call your Service centre if the fault con­tinues. .

centre if the fault continues.

61

Status messages, error messages / fault

13 610 0002 11.2022

7.2 Trouble shooting

DANGER

Electrical hazard

Disconnect the device from the mains before starting any cleaning, mainte­nance or overhaul work.

► Disconnect the mains plug.

Fault description Possible cause Corrective actions

Device does not
work.

No F-SW power out­put

No F-SW power out­put

Shock triggering
noise changes after
several shocks

Tab. 7-1 Trouble shooting

Power failure • Check the power supply.

Defective mains fuse • Replace the fuses.

Defective mains plug • Replace the mains cable.

F-SW handpiece de­fective

Malfunction in con­trol device

Handpiece has not
been recognised

Air in handpiece • Hold handpiece vertically with

• Replace the handpiece.

• Call your service centre

• Check that the black screw is
screwed to the correct tightness.

coupling diaphragm downwards
so that air is sucked out.

62

13 610 0002 11.2022

Status messages, error messages / fault

8 Accessories

Product Description Part Number

Handpiece F-SW SEPIA LT 19000

Handpiece C-ACTOR SEPIA LT 29204.0001

Water bag 4600

Silicone oil 4700

Gel bottle 22601

Stand-off I 15 mm 19100

Stand-off II 30 mm 19200

Stand-off anatomical 19150

Closing ring 19300

Handpiece holder set 13-27268

User manual 13-00061

Color sensitive pressure sensors 13-18342

Mains cable EU 0.0032.012

Trolley/Cart 4560

63

Accessories

13 610 0002 11.2022

9 Technical specifications

Chattanooga Intelect F-SW

F-SW operating mode

C-ACTOR operating mode

F-SW energy selection in steps from 0.01 to 0.55 mJ/mm

C-ACTOR energy selection in steps from 0.03 to 1.24 mJ/mm

Mains input voltage 100 – 240 VAC

Mains frequency 50 / 60 Hz

Mains fuse T5AH / 250 VAC

Power consumption max. 450 VA

Ambient temperature during
operation

Ambient temperature during
storage and transport

Ambient air pressure during
operation

Ambient air pressure during
storage and transport

Air humidity during operation 5 - 55%, non condensing

Air humidity during storage and
transport

Control device weight 23.6 kg

F-SW handpiece weight 990 g

C-ACTOR handpiece weight 990 g

Housing dimensions (W x H x D) 450 x 165 x 530

Classification according to MDD Class IIb device

Protection against ingress of
water

Subject to technical changes

F-SW Single shock, continuous shock

1 - 8 Hz

C-ACTOR Single shock, continuous shock

1 - 8 Hz

2

2

10° - 30°C

0° C to 60°, frost-free

800 - 1060 hPa

500 - 1060 hPa

5 - 95 %, non condensing

64

IPX1

Shock wave source of the F-SW handpiece

Generation method electromagnetic

Pressure wave expansion focused

Focusing method parabolic reflector

Energy flux density [mJ/mm

Peak compressional acoustic pressure
[MPa]

Peak rarefactional acoustic pressure
[MPa]

13 610 0002 11.2022

2

] 0.10 0.35 0.55

14 36 62

9 13 15

Technical specifications

65

Shock wave source of the F-SW handpiece

Axial size of the -6dB focal zone [mm] 57 49 34

Lateral size of the -6dB focal zone [mm] 5.4 3.8 2.8

3

Focal volume [cm

] 0.87 0.37 0.14

Energy per pulse (r = 2.5 mm) [mJ] 1.7 5.5 8.5

F-SW Handpiece

Focus size 5 mm x 5 mm x 30 mm

Depth of focus 50 mm

Depth of focal zone 35 – 65 mm

Therapeutically effective penetration
depth, 5 MPa

0–125 mm

F-SW Handpiece with stand-off device I (short)

Focus size 5 mm x 5 mm x 30 mm

Depth of focus 30 mm

Depth of focal zone 15 – 45 mm

Therapeutically effective penetration
depth, 5 MPa

0–105 mm

F-SW Handpiece with stand-off device II (long)

Focus size 5 mm x 5 mm x 30 mm

Depth of focus 15 mm

Depth of focal zone 0 – 30 mm

Therapeutically effective penetration
depth, 5 MPa

0–90 mm

Shock wave source of the C-ACTOR handpiece

Generation method electromagnetic

Pressure wave expansion focused

Focusing method parabolic reflector

2

Energy flux density [mJ/mm

Peak compressional acoustic pressure

] 0.25 0.76 1.24

18 44 78

[MPa]

Peak rarefactional acoustic pressure

12 20 23

[MPa]

Axial size of the -6dB focal zone [mm] 24 22 18

Lateral size of the -6dB focal zone [mm] 3.9 2.8 2.1

3

Focal volume [cm

] 0.2 0.1 0.04

Energy per pulse (r = 2.5 mm) [mJ] 3.3 9.5 15

C-ACTOR Handpiece

Focus size 3 mm x 3 mm x 20 mm

Depth of focus 30 mm

Depth of focal zone 20 – 40 mm

Technical specifications

13 610 0002 11.2022

C-ACTOR Handpiece

Therapeutically effective penetration
depth, 5 MPa

C-ACTOR Handpiece with stand-off device I (short)

Focus size 3 mm x 3 mm x 20 mm

Depth of focus 15 mm

Depth of focal zone 0 – 20 mm

Therapeutically effective penetration
depth, 5 MPa

C-ACTOR Handpiece with stand-off device II (long)

Focus size 3 mm x 3 mm x 20 mm

Depth of focus 0 mm

Depth of focal zone 0 – 10 mm

Therapeutically effective penetration
depth, 5 MPa

Subject to technical changes

Software Version

The number of the software version of the device can be seen on the touch panel.
Pressing INFO / VERSIONS shows the actual software und hardware versions.

0–65 mm

0–45 mm

0–30 mm

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

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

product.

– The medical product may only be exported to a foreign country if the medical

product and the corresponding indications are allowed there.

9.1 Type plate

Fig. 9-1 Type plate Chattanooga Intelect F-SW

9.2 Conformity with directives

This medical product bears the CE mark in accordance with the Medi­cal Device Directive (MDD) 93/42/EEC.

66

13 610 0002 11.2022

Technical specifications

67

9.3 Conformity with standards

This device complies with the applicable standards EN/IEC 60601-1, CAN /CSA-C22.2
No.601.1, UL Std. No 60601-1.

Acc. to EN/IEC 60601-1

– Type of protection against electric shocks: Protection class 1

– Applied part of type B

The following essential performance characteristics apply to the Chattanooga Intelect
F-SW:

1. The Medical Equipment shall be free from incorrect display of energy levels.

2. The Medical Equipment shall be free from unintended shock wave release.

The essential performance characteristics of the Chattanooga Intelect F-SW cannot be
disturbed by electromagnetic interference (EMI).

9.3.1 EMC guidelines and manufacturer's declaration

Guidelines and manufacturer's declaration  Emitted electromagnetic interference

The Chattanooga Intelect F-SW model is intended to be used in the electromagnetic environment
specified below. The customer or the user of the Chattanooga Intelect F-SW should ensure that it
is used in such an environment.
The maximum length of the mains cable for the unit is 3 m.

Interference emis­sion measurements

HF emissions acc. to
CISPR 11

HF emissions acc. to
CISPR 11

Harmonic emissions
according to IEC
61000-3-2

Voltage fluctuations/
flicker emissions acc.
to IEC 61000-3-3

Conducted RF emis­sions

Radiated RF emis­sions

Compliance

Group 1

Class B

Class A

Complies

Class B

Class B

Electromagnetic environment – guidelines

The Chattanooga Intelect F-SW uses HF energy only for
its internal functioning. Therefore, its HF emissions are
very low and are not likely to cause any interference in
nearby electronic equipment. As per EN IEC 60601-2­36:2015 Section 202, this does not apply when trigger­ing and generating the pressure pulse.

The Chattanooga Intelect F-SW is suitable for use in all
establishments, including domestic establishments and
those directly connected to the public low-voltage
power supply network that supplies buildings used for
domestic purposes.

Technical specifications

13 610 0002 11.2022

Guidelines and manufacturer's declaration  Resistance to emitted electromagnetic in-

terference

The Chattanooga Intelect F-SW model is intended to be used in the electromagnetic environment
specified below. The customer or the user of the Chattanooga Intelect F-SW should ensure that it
is used in such an environment.

Immunity
tests

Electrostatic
discharge
(ESD) acc. to
IEC 61000-4-2

Electrical fast
transient dis­turbances /
bursts accord­ing to IEC

IEC 60601
test level

±8 kV contact
discharge
±15 kV air dis­charge

±2 kV for
mains cables
±1 kV for in­put/output
lines

Compliance
level

±8 kV contact
discharge
±15 kV air dis­charge

±2 kV for
mains cables
±1kV for in­put/output
lines

Electromagnetic environment – guidelines

Floors should be made of wood or concrete, or
be covered with ceramic tiles. If floors are cov­ered with synthetic material, the relative air hu­midity must be at least 30%.

Mains power quality should be that of a typical
commercial or hospital environment.

61000-4-4

Surges ac­cording to IEC
61000-4-5

Voltage drops,
short interrup­tions and volt­age variations
on power sup­ply input lines
acc. to IEC
61000-4-11

Power
frequency (50/
60 Hz) mag­netic field acc.

±1 kV line(s)
to line(s)

±2 kV line(s)
to earth

< 5% U

a

T

(> 95% drop
in UT) for ½
and 1 period

70 % U

T

(30% drop in
UT) for 25/30
periods

< 5% UT

(> 95% drop

) for 250/

in U

T

300 s

±1 kV line(s)
to line(s)

±2 kV line(s)
to earth

< 5% U

(> 95% drop
in UT) for ½
and 1 period

70 % U

(30% drop in
UT) for 25/30
periods

< 5% UT

(> 95% drop

) for 250/

in U

T

300 s

30 A/m 30 A/m

Mains power quality should be that of a typical
commercial or hospital environment.

T

Mains power quality should be that of a typical
commercial or hospital environment.

If the user of the Chattanooga Intelect F-SW re­quires continued operation during mains power

T

interruptions, it is recommended that the Chat­tanooga Intelect F-SW be powered from an un­interruptible power supply or a battery.

The mains frequency magnetic fields should be
those of a typical business or hospital environ­ment.

to IEC 61000­4-8

a. NOTE: UT is the mains alternating voltage prior to application of the test level.

68

13 610 0002 11.2022

Technical specifications

69

Guidelines and manufacturer's declaration  Resistance to emitted electromagnetic in-

terference

The Chattanooga Intelect F-SW model is intended to be used in the electromagnetic environment
specified below. The customer or the user of the Chattanooga Intelect F-SW should ensure that it
is used in such an environment.

Immunity
tests

IEC 60601
test level

Compliance
level

Electromagnetic environment – guidelines

Portable and mobile RF equipment should be
used no closer to any part of the Chattanooga
Intelect F-SW, including cables, than the recom­mended safety distance calculated from the
equation applicable to the frequency of the
transmitter.

Recommended safety distance:

Conducted RF
according to
IEC 61000-4-6

Radiated HF
interference
according to
IEC 61000-4-3

/6V

3V

RMS

RMS

150 kHz to 80
MHz

10 V/m
80 MHz to 2.7
GHz

3V

/6V

RMS

150 kHz to 80
MHz

10 V/m
80 MHz to 2.7
GHz

d = 1.2√ P

RMS

d = 1.2√ P
for 80 MHz to 800 MHz

d = 2.3√ P
for 800 MHz to 2.7 GHz

Where P is the rated power of the transmitter in
watts (W) according to the transmitter manufac­turer and d is the recommended safety distance
in metres (m).

The field intensity of stationary radio transmit-

a

ters, based on an on-site inspection
less than the compliance level.

should be

b

Interference may occur in the vicinity of devices
marked with the following symbol:

NOTE 1:

At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2:

These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorp­tion and reflection from structures, objects and people.

a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment with respect to fixed RF transmitters, an electromagnetic site survey should be considered. If the
measured field strength at the location in which the Chattanooga Intelect F-SW is used exceeds the applicable HF compliance
level indicated above, the Chattanooga Intelect F-SW should be observed to verify normal operation. If abnormal performance
is observed, additional measures may be necessary, such as re-orienting or relocating the Chattanooga Intelect F-SW.

b. Over the frequency range of 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

Technical specifications

13 610 0002 11.2022

Recommended safety distances between portable and mobile HF communications equip-

ment and the Chattanooga Intelect F-SW

The Chattanooga Intelect F-SW is intended for use in an electromagnetic environment in which ra­diated HF disturbances are controlled. The operator or the user of the Chattanooga Intelect F-SW
can help prevent electromagnetic interference by maintaining a minimum distance between porta­ble and mobile HF communications equipment (transmitters) and the Chattanooga Intelect F-SW,
as recommended below,
according to the maximum output power of the communications equipment.

Rated power of
transmitter [W]

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended safety dis­tance can be estimated using the equation applicable to the frequency of the transmitter, where P
is the rated power of the transmitter in watts [W] according to the transmitter manufacturer.

NOTE 1:

An additional factor of 10/3 was used for calculating the recommended safety distance of trans­mitters in the frequency range from 80 MHz to 2.7 GHz in order to reduce the probability that a
mobile/portable communications device brought into the patient area might inadvertently lead to
a malfunction.

NOTE 2:

These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorp­tion and reflection from structures, objects and people.

Safety distance according to transmission frequency [m]

150 kHz to 80 MHz

d = 1.2 √P

80 MHz to 800 MHz

d = 1.2 √P

800 MHz to 2.5 GHz

d = 2.3 √P

70

13 610 0002 11.2022

Technical specifications

9.4 Certificates

71

Fig. 9-2 Declaration of Conformity

Technical specifications

13 610 0002 11.2022

9.5 Symbols and labels

The following symbols and labels are affixed to the Chattanooga Intelect F-SW:

Fig. 9-3 Symbols and labels at the front cover

1 Foot switch connection
2 F-SW handpiece connection
3 Applied part of type B

Label Notification

1 foot switch connection

2 F-SW handpiece connection

3 Applied part of type B

Tab. 9-1 Symbols attached to the front side

72

13 610 0002 11.2022

Technical specifications

73

Fig. 9-4 Symbols and labels at the back cover

1 Potential equalisation
2 USB-connection
3 Comply with the OM
4 Type plate

Label Notification

1 Potential equalisation

2 USB-connection

3

4

Tab. 9-2 Symbols attached to the rear side

It is essential to comply with the
operating manual

Type plate

Technical specifications

13 610 0002 11.2022

The following symbols and labels are on the type plate of the Chattanooga

Intelect F-SW

Label Meaning

fuse

Applied part of type B

CSA certification

manufacturer

CE mark (in compliance with Medical Device
Directive (MDD) 93/42/EEC)

DataMatrix according to GS1 standards

Unique Device Identification (UDI): Human
Readable Interpretation (HRI)

(01) Global Trade Item Number (GTIN)

(21) Application Identifier (AI): Serial Number (SN)

(11) Application Identifier (AI): Production Date

(PRODDATE)

Tab. 9-3 Device labelling

The following symbols and labels are attached to the Chattanooga Intelect F-SW pack­aging:

Label Meaning

Ambient temperature during storage and
transport

Air humidity during storage and transport

Ambient air pressure during storage and
transport

74

Tab. 9-4 Labelling on the packaging

13 610 0002 11.2022

Technical specifications

75

10 Warranty and service

10.1 Warranty for the control device

During the two-year warranty period from the date of invoice, defects will be either
replaced or repaired at the discretion of the manufacturer and at no charge to the cus­tomer upon the customer furnishing adequate proof that the defect is due to defects
in material or workmanship. The warranty does not extend to wear parts.

Transport costs and the risk of loss during the shipping of returned products shall be
borne by the customer.

NOTICE

Unauthorised opening, repairs and modifications to the device by unauthorised per­sons

releases the manufacturer from any liability for the safe system operation.
This will automatically void the warranty even before the end of the warranty
period.

► Do not open the device without authorisation and do not manipulate the device.

10.2 Warranty for the handpiece

The F-SW handpiece and the C-ACTOR handpiece are wear parts.
New handpieces that have performed up to 1 million pulses will be either replaced or
repaired at the discretion of the manufacturer and at no charge to the customer upon
the customer providing adequate proof that the defect is due to defects in material or
workmanship.
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.
The coil is a wear part. It is not covered by the handpiece’s warranty.

Modifications to the device are not permitted.

Any opening, repair or modification of the handpiece and the stand-off devic­es are not permitted. Any opening, repair or modification of the instruments
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.

10.3 Service

If you have any other questions about the Chattanooga Intelect F-SW, please contact
your certified dealer.

Warranty and service

NOTICE

13 610 0002 11.2022

Medical devices identified with this CE mark are in accordance with the regu­lations in EC Directive 93/42/EEC “Council Directive concerning medical devic­es”

The operating manual, including all of its parts, is protected by copyright. Any use out­side the narrow limits of copyright law without the written consent of the manufac­turer is inadmissible and liable to prosecution.

This applies in particular to duplication, translation, microfilming as well as feeding and
distribution in electronic systems.

Manufacturer / Publisher

EXCLUSIVELY DISTRIBUTED BY:

DJO France SAS | Centre Européen de Fret | 3 rue de Bethar | 64990 Mouguerre |
France

T: + 33 (0) 5 59 52 86 90 | F: + 33 (0) 5 59 52 86 91

76

13 610 0002 11.2022

Warranty and service