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
9TechnicalSpecications71
9.1TechnicalSpecications71
9.2 Type plate Chattanooga Intelect F-SW 75
9.3 Conformity with directives 75
4
9.4 Conformity with standards 75
9.5Certicates80
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
Table of Contents
13 610 02 1018
Preface
Warning notes
This manual contains warnings, safety instructions and specic 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.
5
13 610 02 1018
Other instructions
NOTE
Additional information concerning specic features or operating instructions is
preceded by the term 'NOTE'.
Preface
Safety signs and other symbols used in this manual
Symbol Name
General warning sign
Electrical warning sign
Table 1-1
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.
6
Preface
13 610 02 1018
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 prociency, 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
precOnditiOnsfOrOperatiOn).
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 precOnditiOnsfOrOperatiOnin 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-
nalchecks.
7
13 610 02 1018
• Have the maintenance procedures recommended by the manufacturer carried out by
authorised personnel (see also chapter 6.6 Maintenanceandsafetychecks).
No treatment ist permitted if a display on the control device or a touch screen fails.
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 Chattanooga 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 identied as follows:
8
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 classication AP as per IEC 60601.
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.
General Safety Information
13 610 02 1018
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 signicantly 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 chapter9.4 cOnfOrMitywithstandards.
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 specication.
9
13 610 02 1018
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!
General Safety Information
Set-up and operation
• Check that the installation surfaces have sufcient 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 functiOnalchecks.
• 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.
10
General Safety Information
13 610 02 1018
1.3 Manufacturer‘s responsibility
WARNING!
No modications 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 specied by the manu-
facturer
– Installation, expansions, conversions, new installations, modications 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 specied 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 disposable articles that have been checked by the testing body responsible for testing the
device to ensure that they function without risk.
11
13 610 02 1018
General Safety Information
12
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 specied
– Treatment of deep muscle trigger points
– Treatment of supercial muscle trigger points
– Myofascial pain syndrome / Myofascial trigger points* / Acupuncture points
– e.g. chronic back pain (cervical and lumbar parts of vertebral column), trape-
– Insertion tendonitis in general
– Supercial insertion tendonitis (paratendinary area)
– Shoulder pain with or without calcications / tendinopathy of the shoulder,
the supraspinatus, or / and the rotator cuff (with or without calcications)
– 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.
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13 610 02 1018
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 contraindications.
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
14
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.
Principles
13 610 02 1018
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 efciently 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 responsibility 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
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
78
7 Water supply connection
8 not used
9 Type plate
6
13 610 02 1018
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 diagnosis.
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.
17
13 610 02 1018
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 Iwith stand-off device II
Fig. 3-4 F-SW handpiece or C-ACTOR handpiece
18
Therapeutically effective
penetration depth 5 MPa
50 mm
0 - 125 mm
0 - 105 mm
30 mm
15 mm
0 - 90 mm
Fig. 3-5 Depth of therapeutical effect of F-SW handpiece
Depth of
focal zone
35 - 65 mm
15 - 45 mm
0 - 30 mm
System Description
13 610 02 1018
Therapeutically effective
penetration depth 5 MPa
0 - 65 mm
Depth of
focal zone
30 mm
20 - 40 mm
0 - 50 mm
15 mm
5 - 25 mm
0 mm
0 - 35 mm
0 - 10 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
thestand-Offdevice.
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), deformation of the surface in the coupling area or leaks.
The stand-off should be replaced at least every 12 months.
19
13 610 02 1018
System Description
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
20
• Carefully remove the instrument and accessories from the packaging container.
• Check that all items are included in the packaging container and that they are not
damaged.
• Contact your supplier or the manufacturer immediately if any items are missing or
damaged.
• Retain the original packaging. It may prove useful for any later equipment transport.
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.
Installation Instruction
13 610 02 1018
4.4 Handpiece holder installation
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. 4-7 Mounted handpiece holder
1
4.4.1 Installing the F-SW holding arm (optionally)
To facilitate handling of the F-SW handpiece, you can hook the F-SW
handpiece onto the optionally available holding arm.
• Use a 2.5 mm Allen key for installation.
• Screw the holder for the arm rmly onto the holes provided for it on the left of the
instrument (see picture below).
21
13 610 02 1018
Fig. 4-8 Attachment holes for the holding arm
• Place the holding arm into the holder.
Installation Instruction
22
Fig. 4-9 Holding arm attached
4.4.2 Connecting power supply cables
• Connect the Chattanooga Intelect F-SW via the mains cable to the mains connector (Fig. 3-2/3).
4.4.3 Handpiece connection
• 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 nger-tight.
Fig. 4-10 Connecting the F-SW handpiece
NOTE
Fill the water circuit of the Chattanooga Intelect F-SW rst when the F-SW handpiece is rst connected after delivery. The instrument will signal “water level too
low” when it is switched on.
Installation Instruction
13 610 02 1018
4.4.4 Connecting the optional foot switch
• Connect the connection cable of the foot switch to the appropriate connection
on the front side of the instrument.
NOTE
The foot switch is protected against ingress of water according to classication
IPX8 as per IEC 60529.
4.4.5 Potential equalisation (optional)
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!
The potential equalisation connection on the Chattanooga Intelect
F-SW must be connected in accordance with the relevant national
regulations.
4.4.6 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
The connected instruments must be approved as medical products in accordance with
IEC 60601.
23
13 610 02 1018
Installation Instruction
4.5 Transport
NOTE
Make sure that your hands are dry and free of grease.
ATTENTION !
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).
• 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.
24
1
Fig. 4-11 Transporting the device
• Set the device slantly down in order to avoid squeezing the ngers.
4.6 Compatibility
The Chattanooga Intelect F-SW is allowed to be operated with the following accessories:
– Handpiece F-SW SEPIA LT Art. no. 19000
– Handpiece C-ACTOR SEPIA LT Art. no. 29204.0001
– Foot switch
Installation Instruction
13 610 02 1018
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 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):
1
Control buttons
9
2
Control buttons
3
4
5
Control buttons
8
7
Fig. 5-12 Controls
1 - 3 Top navigation bar
4 Status bar
5 Selection area
6 - 8 Bottom navigation bar
9 Parameter display (nominal and actual values)
NOTE
The following functional description refers to control software version
13441.19.x.x or later (this can be seen in the Info menu).
Control buttons
6
25
13 610 02 1018
Operation
Navigation bars:
The top and bottom navigation bars (Fig. 5-12/1 to Fig. 5-12/3 and 3, Fig. 5-12/6
to Fig. 5-12/8) contain control buttons that you can use for navigating through
the menus:
Parameter entry screen:
Open the sub-menu
Jump to the “Load conguration” sub-menu (call
up saved parameter congurations or patient
records)
Main and sub-menu:
Step back
Return to parameter entry screen
Delete congurations
Save congurations
Conrm entries, acknowledge messages
26
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 ag on the right of the status bar displays the
menu language. Touching the ag 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 “Warnings” sub-menu
that displays all warning messages that are currently
active.
The name of the loaded conguration/patient
record (* indication/patient name) is displayed.
Operation
13 610 02 1018
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