Chattanooga Intelect Focus Shockwave User manual

Operating Manual
Chattanooga Intelect F-SW
Published: October 2018
Original language: German
Publisher:
STORZ MEDICAL AG
Lohstampfestr. 8
CH-8274 Tägerwilen
Switzerland
TT.####
29097.0002
Part No. 26933.0012
Focus Shockwave
Operating Manual

13 610 02 1018
2
Table of Contents
Table of Contents
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
1.2 Warning against damage to equipment and the device 9
1.3 Manufacturer‘s responsibility 11
1.4 Owner‘s responsibility 11
2 Principles 12
2.1 Physical principles 12
2.1.1 Indications . . . . . . . . . . . . . . . . . . . . . 12
2.1.2 Contraindications . . . . . . . . . . . . . . . . . . . 14
2.1.3 Side effects . . . . . . . . . . . . . . . . . . . . . 14
2.2 Preconditions for operation 15
2.2.1 Operating personnel . . . . . . . . . . . . . . . . . . 15
2.2.2 Training of the operator . . . . . . . . . . . . . . . . . 15
3 System Description 16
3.1 Control and functional elements 16
3.2 F-SW handpiece and optional C-ACTOR handpiece 17
3.3 Use of stand-off devices 18
4 Installation Instruction 20
4.1 Scope of supply 20
4.2 Unpacking 20
4.3 Correct positioning of the device 20
4.4 Handpiece holder installation 21
4.4.1 Installing the F-SW holding arm (optionally) . . . . . . . . . . . 21
4.4.2 Connecting power supply cables . . . . . . . . . . . . . . 22
4.4.3 Handpiece connection . . . . . . . . . . . . . . . . . 22
4.4.4 Connecting the optional foot switch . . . . . . . . . . . . . 23
4.4.5 Potential equalisation (optional). . . . . . . . . . . . . . . 23
4.4.6 USB connection . . . . . . . . . . . . . . . . . . . 23
4.5 Transport 24
4.6 Compatibility 24

13 610 02 1018
3
Table of Contents
5 Operation 25
5.1 User interface 25
5.2 Overview of menu functions 29
5.3 Starting the instrument 32
5.4 Setting the treatment parameters 34
5.5 F-SW Energy display task 36
5.6 Storing the treatment parameters 37
5.7 Loading treatment parameters 39
5.7.1 Pre-programmed indications from the manufacturer . . . . . . . . 39
5.7.2 In-house applications . . . . . . . . . . . . . . . . . . 41
5.8 Patient record 42
5.9 Visual analogue scale (VAS) 44
5.10 Data transfer 45
5.11 Software updates 48
5.11.1 Loading the software onto the USB stick . . . . . . . . . . . . 48
5.11.1.1 Extracting the software using Windows . . . . . . . . . . . . 48
5.11.2 Extracting the software with WinZip . . . . . . . . . . . . . 49
5.11.3 Updating the software on the instrument . . . . . . . . . . . . 50
5.12 Resetting the treatment shock counter 50
5.13 “Autofrequency” function 51
5.14 Start-up 52
5.15 Functional checks 54
5.16 Standard settings 54
5.17 Treatment 55
5.18 Switching off the device 55
6 Cleaning, Maintenance and Overhaul 56
6.1 Cleaning the device 56
6.2 Cleaning the handpiece 57
6.2.1 Changing the stand-off device . . . . . . . . . . . . . . . 57
6.2.2 Reprocessing of the handpiece and the stand-off devices . . . . . . . 58
6.2.2.1 Cleaning. . . . . . . . . . . . . . . . . . . . . . 58
6.2.2.2 Disinfection . . . . . . . . . . . . . . . . . . . . . 58
6.3 Cleaning the optional foot switch 59
6.4 Water renewal 60
6.4.1 Draining the water circuit . . . . . . . . . . . . . . . . 60

13 610 02 1018
4
Table of Contents
6.4.2 Filling the water circuit . . . . . . . . . . . . . . . . . 62
6.4.3 Bleeding the water circuit . . . . . . . . . . . . . . . . 64
6.4.4 Resetting the water renewal time . . . . . . . . . . . . . . 64
6.5 Fuse replacement 65
6.6 Maintenance and safety checks 65
6.7 Disposal 66
6.8 Repair 66
6.9 Service life 66
7 Status messages and trouble-shooting 67
7.1 Status messages 67
7.2 Trouble-shooting 69
8 Accessories 70
9 TechnicalSpecications 71
9.1 TechnicalSpecications 71
9.2 Type plate Chattanooga Intelect F-SW 75
9.3 Conformity with directives 75
9.4 Conformity with standards 75
9.5 Certicates 80
9.6 Symbols and labels 81
10 Warranty and Service 84
10.1 Warranty for the control device 84
10.2 Warranty for the F-SW handpiece and the C-ACTOR Handpiece 85
10.3 Service 85

13 610 02 1018
5
Preface
Preface
Warning notes
This manual contains warnings, safety instructions and specic 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 the possible consequences!
• The instructions for avoiding the danger are given here.
CAUTION indicates that incorrect operation could lead to minor injuries.
CAUTION!
The source of the danger is stated here.
These are the possible consequences!
• The instructions for avoiding the danger are given here.
ATTENTION indicates that incorrect operation could lead to damage to the device.
ATTENTION!
The source of the danger is stated here.
These are the possible consequences!
• The instructions for avoiding the danger are given here.
Other instructions
NOTE
Additional information concerning specic features or operating instructions is
preceded by the term 'NOTE'.

13 610 02 1018
6
Preface
Safety signs and other symbols used in this manual
Symbol Name
General warning sign
Electrical warning sign
Wear hearing protection!
WEEE (waste electrical and electronic equipment)
Device serial number
CE mark
Electromagnetic interference may occur in the vicinity of
instruments marked with this symbol.
Table 1-1

13 610 02 1018
7
General Safety Information
1 General Safety Information
1.1 Instructions for safe use
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 Chattanooga Intelect F-SW.
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 prociency, and knowledge of the operating manual.
The Chattanooga Intelect F-SW is intended exclusively for use by healthcare
professionals who have been trained to use the device (see also chapter 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 chapter 2.2.
All status and error messages signaled during treatment must always be attended to
without delay.
While applying focused shockwaves at maximum adjustment, do not use more than
6.000 subsequent shocks and stick to a consecutive break of 5 minutes.
Checks and inspections prior to treatment
Before using the device, the user must make sure it is functioning safely and that it is
in proper condition.
• It is essential to perform the functional checks after switching on the Chattanooga
Intelect F-SW before starting treatment. Read about this in chapter 5.15 functiO-
nal checks.
• Have the maintenance procedures recommended by the manufacturer carried out by
authorised personnel (see also chapter 6.6 Maintenance and safety checks).
No treatment ist permitted if a display on the control device or a touch screen fails.

13 610 02 1018
8
General Safety Information
Protection against electrical hazard
Sources of voltage can give rise to currents as a result of body resistance which not
only ow through the patient but can also impair or even endanger the physician and
the nursing staff.
• Therefore, always connect the potential equalisation connector of the Chattanoo-
ga Intelect F-SW in accordance with national guidelines.
• Devices which are not medical products in accordance with EN 60601 must be set
up outside the vicinity of the patient.
• Do not touch electrical connectors while you are touching the patient.
• Disconnect the connected handpieces from the device before carrying out cleaning
and maintenance work. Do not reconnect them until they have been completely
reassembled!
• Do not try to open the instrument! Risk of electric shocks!
Protection against high voltage
Very high voltages are generated when operating the device.
High-voltage components are identied 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 suitably authorised by the manufacturer.
Protection against noise
The noise level during administration of shock waves is within the safe area.
Nevertheless, we recommend wearing suitable ear protection during treatment in
order to minimise exposure to noise.
Protection against explosion
Do not use the Chattanooga Intelect F-SW in potentially explosive environments, i.e.
in the presence of a ammable anaesthetic mixture with air or with oxygen or nitrous
oxide.
The optional foot switch must not be used in potentially explosive atmospheres accor-
ding to classication AP as per IEC 60601.

13 610 02 1018
9
General Safety Information
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 reduction
is signicantly weakened by the bone structure.
Shock waves can give rise to undesirable heart reactions. The patient must be
continuously observed during the treatment.
• 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.
• Only perform treatments approved by the manufacturer!
The user is responsible for correctly positioning the handpieces and correctly selecting
the treatment zone.
Air bubbles reduce the effectiveness of shock waves. Therefore, air bubbles must
always be removed from the shock wave path.
1.2 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) can interfere with medical electrical equipment.
This device is subjected to special precautions regarding EMC and needs to be
installed according the EMC guidelines in chapter 9.4 cOnfOrMity with standards.
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.
The Chattanooga Intelect F-SW is not allowed to be positioned immediately next
to or jointly with other devices. If the 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 specication.
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
The system must only be connected to properly earthed and correctly installed
shockproof sockets!

13 610 02 1018
10
General Safety Information
Set-up and operation
• Check that the installation surfaces have sufcient carrying capacity to avoid
equipment damage!
There are ventilation slits on the left side of the device which must not be covered by
other objects.
• Check that the system is in perfect working order before each use. Read about this in
chapter 5.15 functiOnal 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.
• Make sure that no cables are crushed or sheared.
Disposal
• Comply with national disposal regulations when disposing of the Chattanooga
Intelect F-SW or individual components.
• Comply with the relevant information in the operating manuals for the additional
devices.

13 610 02 1018
11
General Safety Information
1.3 Manufacturer‘s responsibility
WARNING!
No modications are to be made to this device without the permission
of the manufacturer.
STORZ MEDICAL AG as the manufacturer of the Chattanooga Intelect F-SW is only
responsible for effects on the safety, reliability and performance of its product if:
– Maintenance of the device is performed at the intervals specied by the manu-
facturer
– Installation, expansions, conversions, new installations, modications or repairs
are performed by people authorised by the manufacturer
– The electrical installation in the rooms in question corresponds to the require-
ments of DIN/IEC
– The device is used in compliance with the operating manual
The periodic maintenance measures specied by the manufacturer must be performed
on schedule by authorised personnel.
The manufacturer‘s liability shall be rendered null and void if non-genuine parts are
used.
1.4 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 dispo-
sable articles that have been checked by the testing body responsible for testing the
device to ensure that they function without risk.

13 610 02 1018
12
Principles
2 Principles
2.1 Physical principles
The Chattanooga Intelect F-SW is a universal, compact shock wave unit that can be
used for treatment involving medium- to high-energy electromagnetically generated
shock waves - focused shock waves – referred to below as F-SW.
F-SW waves have a short pulse length and are concentrated on areas a few
millimetres in diameter, allowing pulse waves to be applied to a tightly localised area,
even in deeper tissue layers.
2.1.1 Indications
The Chattanooga Intelect F-SW is designed in order to treat the indications specied
below:
Orthopaedics / Pain Therapy
– Plantar fasciitis / heel spur / heel pain / calcaneal spur
– Trigger Point Therapy
– Treatment of deep muscle trigger points
– Treatment of supercial muscle trigger points
– Myofascial pain syndrome / Myofascial trigger points* / Acupuncture points
– e.g. chronic back pain (cervical and lumbar parts of vertebral column), trape-
zius, pelvic oor muscle trigger points
– Tendinopathy / Tendinitis / Tendonitis / Tendinosis / Tendon Pain
– Insertion tendonitis in general
– Supercial insertion tendonitis (paratendinary area)
– Shoulder pain with or without calcications / tendinopathy of the shoulder,
the supraspinatus, or / and the rotator cuff (with or without calcications)
– (Radial/ulnar humeral) epicondylitis / tennis elbow / golfer’s elbow / elbow
tendinopathy
– Greater trochanteric pain syndrome (GTPS) / Trochanteric tendonitis / Tro-
chanteric bursitis
– Hamstring tendinopathy
– Patellar tip syndrome/ proximal iliotibial band (friction) syndrome / Patellar
tendonitis / Jumper’s knee
– Tibial edge syndrome / tibial stress syndrome / tibial tendonitis
– Achillodynia / Achilles tendinitis
– Pseudarthrosis / non-unions / delayed unions

13 610 02 1018
13
Principles
Dermatology
– Wound healing
– Ulceration
– Arterial ulcers
– Venous ulcers
– Diabetic foot ulcers
– Pressure sore / Decubital ulcer
– Burns
– Acute and chronic lesions
– Traumatic and post-traumatic skin lesions
– Wounds with disturbed healing
– Postsurgical wounds
– Cellulitis / lipo- / lymphedema
Urology
– CPPS / prostatitis
– IPP / Peyronie’s disease
– Vascular / vasculogenic / organic erectile dysfunction
Neurology
– Spastic muscle paralyses (caused by infantile cerebral palsy or stroke for exam-
ple)
* 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 eld of trigger point shock wave therapy.

13 610 02 1018
14
Principles
2.1.2 Contraindications
CAUTION !
The contraindications listed here are examples. No claims are made
regarding the completeness or unlimited validity of this list of contra-
indications.
No patient treatment is allowed under the following circumstances:
– Air-lled tissue (in particular lung tissue) in the treatment area
– Brain or spine in the treatment area
– Untreated coagulopathies (hemophilia)
– Malignant tumor 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 rst treatment
CAUTION!
Shock waves must not be applied to target areas located above air
lled tissue (lungs), nor to any regions near large nerves, vessels,
the spinal column or head (apart from the face).
2.1.3 Side effects
– Swelling, reddening, hematoma
– Petechiae
– Pain
These side effects normally disappear after 5-10 days.

13 610 02 1018
15
Principles
2.2 Preconditions for operation
2.2.1 Operating personnel
The Chattanooga Intelect F-SW is intended exclusively for use by healthcare
professionals who have been trained to use the device.
Such a specialist is expected to have practical knowledge of medical procedures and
applications as well as of the terminology, and should be experienced in treating the
indications stated in chapter 2.1.1 indicatiOns.
Users must have basic physical and cognitive abilities such as vision, hearing and
literacy, and have basic functional use of their upper extremities.
The device is designed for a demographic target group between 18 and 65 years.
2.2.2 Training of the operator
Operators of the Chattanooga Intelect F-SW must have been adequately trained in
using this system safely and efciently before they operate the device described in
this handbook. An introduction to the principles of operation will be provided by your
dealer with reference to this operating manual and will be documented in the system
logbook.
The operator must be instructed in the following points:
– Instruction in the operation and intended use of the device with practical exer-
cises
– 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 of the therapy waves
– Explanation of the warnings in all operating modes
– Instruction in 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. However, you can also contact the following address
directly:
DJO France
3 Rue de Bethar
Centre Européen de Frêt
64990 Mouguerre
France
T: [phone]
F: [phone]
E: [email protected]

13 610 02 1018
16
System Description
3 System Description
3.1 Control and functional elements
123
4
1 Monitor
2 Power indicator
3 Connection for foot switch
4 F-SW handpiece connection
Fig. 3-1 Front view of Chattanooga Intelect F-SW
1 2 3 4 5
6
78
9
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
Fig. 3-2 Rear view of Chattanooga Intelect F-SW

13 610 02 1018
17
System Description
NOTE
The following instruments can be connected to the USB connection:
– USB memory stick which supports the USB V1.1 protocol
– USB mouse
– USB keyboard
The connected instruments must be approved as medical products in accordance
with EN IEC 60601.
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 diagno-
sis.
NOTE
Optical difference between F-SW handpiece and C-ACTOR handpiece:
The F-SW handpiece has a blue ring around the coupling diaphragm and the
C-ACTOR handpiece has a red ring around the coupling diaphragm.
1
2
3
4
1 Trigger button
2 Clamping ring
3 Fixing screws
4 Coupling diaphragm
Fig. 3-3 F-SW handpiece or C-ACTOR handpiece
The coupling diaphragm is xed by a clamping ring and 3 xing 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.

13 610 02 1018
18
System Description
3.3 Use of stand-off devices
The penetration depth of the shock wave can be adjuted by using different stand-off
devices.
without stand-off device
with stand-off device I with stand-off device II
Fig. 3-4 F-SW handpiece or C-ACTOR handpiece
Therapeutically effective
penetration depth 5 MPa
0 - 125 mm
0 - 105 mm
0 - 90 mm
Depth of
focal zone
35 - 65 mm
15 - 45 mm
0 - 30 mm
15 mm
30 mm
50 mm
Fig. 3-5 Depth of therapeutical effect of F-SW handpiece

13 610 02 1018
19
System Description
Therapeutically effective
penetration depth 5 MPa
0 - 65 mm
0 - 50 mm
0 - 35 mm
Depth of
focal zone
20 - 40 mm
5 - 25 mm
0 - 10 mm
0 mm
15 mm
30 mm
Fig. 3-6 Depth of therapeutical effect of C-ACTOR handpiece
• Perform changing of the stand-off devices as described in chapter 6.2.1 changing
the stand-Off device.
NOTE
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), defor-
mation of the surface in the coupling area or leaks.
The stand-off should be replaced at least every 12 months.

13 610 02 1018
20
Installation Instruction
4 Installation Instruction
4.1 Scope of supply
The standard scope of supply of the Chattanooga Intelect F-SW:
– Chattanooga Intelect F-SW
– F-SW SEPIA LT handpiece
– Handpiece holder
– Mains cables
– Gel bottle
– Silicone oil bottle
– Water bag
– User manual
4.2 Unpacking
• Carefully remove the instrument and accessories from the packaging container.
• Check that all items are included in the packaging container and that they are not
damaged.
• Contact your supplier or the manufacturer immediately if any items are missing or
damaged.
• Retain the original packaging. It may prove useful for any later equipment trans-
port.
4.3 Correct positioning of the device
Make sure that the device is positioned at a distance from the wall so that the mains
plug can be pulled without restriction.