Operating Manual
115 Pages
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Page 1
Focus Shockwave Operating Manual 13 370 02 0518
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13 370 02 0518
Table of Contents General Information 1.1
Introduction
1.1.1
Indications . . . . . . . . . . . . . . . . . . . . . . . 1-5
1.1.2
Contraindications
1.1.3
Warnings . . . . . . . . . . . . . . . . . . . . . . . 1-5
1.1.4
Precautions .
1.2
Symbols
1-7
1.3
Requirements for operating the Chattanooga Intelect F-SW USA
1-8
1.3.1
Operator
1.3.2
Training of the operator
1.4
Description of controls and functional elements
1.4.1
Chattanooga Intelect F-SW USA . . . . . . . . . . . . . . . . 1-9
1.4.2
F-SW handpiece
1.5
Use of stand-off devices
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1-3 .
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1-5 1-6
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1-8 1-9
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1-10 1-10
Installation Instruction 2.1
Unpacking
2-3
2.2
Scope of supply
2-3
2.3
Installation
2-4
2.3.1
Handpiece holder installation . . . . . . . . . . . . . . . . . 2-4
2.3.2
Installing the F-SW holding arm (optionally) ���������������������������������������������������������������� 2-4
2.3.3
Connecting power supply cables
2.3.4
Handpiece connection . . . . . . . . . . . . . . . . . . . 2-5
2.3.5
Connecting the optional foot switch .
2.3.6
Potential equalisation (optional) . . . . . . . . . . . . . . . . 2-6
2.3.7
USB connection . . . . . . . . . . . . . . . . . . . . . 2-6
2.3.8
Transporting the instrument
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. 2-5 . 2-6
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Operation 3.1
General warnings and safety information
3-3
3.2
Operation
3-6
3.2.1
User interface . . . . . . . . . . . . . . . . . . . . . . 3-6
3.2.2
Overview of menu functions . . . . . . . . . . . . . . . . . 3-10
3.2.3
Starting the instrument .
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3-13
3.2.4
Setting the treatment parameters . . . . . . . . . . . . . . .
3-14
3.2.5
Storing the treatment parameters . . . . . . . . . . . . . . .
3-15
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3.2.6
Loading treatment parameters . . . . . . . . . . . . . . . .
3.2.6.1
Pre-programmed indications from the manufacturer �������������������������������������������������� 3-17
3.2.6.2
In-house applications .
3.2.6.3
Patient record . . . . . . . . . . . . . . . . . . . . .
3-20
3.2.6.4
Printing data* . . . . . . . . . . . . . . . . . . . . .
3-23
3.2.6.5
Data transfer
3-24
3.2.7
Software updates
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3-26
3.2.7.1
Loading the software onto the USB stick
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3-26
3.2.7.2
Updating the software on the instrument . . . . . . . . . . . . . 3-28
3.2.8
Resetting the treatment shock counter . . . . . . . . . . . . . . 3-29
3.2.9
“Autofrequency” function .
3.3
Start-up
3-30
3.4
Functional checks
3-32
3.5
Standard settings
3-32
3.6
Treatment
3-33
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3-17 .
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3-19
3-29
Cleaning, Maintenance, Overhaul 4.1
Cleaning
4-3
4.1.1
Cleaning the instrument .
4.1.2
Cleaning the F-SW handpiece .
4.1.2.1
Changing the stand-off device . . . . . . . . . . . . . . . . . 4-4
4.1.2.2
Reprocessing of the handpiece and the stand-off devices ������������������������������������������� 4-5
4.1.2.3
Cleaning . . . . . . . . . . . . . . . . . . . . . . . 4-5
4.1.2.4
Disinfection
4.1.3
Cleaning the optional KARL STORZ foot switch ���������������������������������������������������������� 4-6
4.2
Water renewal
4.2.1
Draining the water circuit . . . . . . . . . . . . . . . . . . 4-7
4.2.2
Filling the water circuit
4.2.3
Bleeding the water circuit . . . . . . . . . . . . . . . . . . 4-11
4.2.4
Resetting the water renewal time . . . . . . . . . . . . . . .
4-11
4.3
Fuse replacement
4-12
4.4
Maintenance and safety checks
4-12
4.5
Disposal
4-13
4.6
Repair
4-13
4.7
Service life
4-13
4.7.1
Service life of the handpiece . . . . . . . . . . . . . . . . . 4-13
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4-3 . 4-4
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. 4-9
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Status Messages and Trouble-shooting 5.1
Status messages
5-3
5.2
Trouble-shooting
5-4
Accessories 6.1
Accessories
6-3
Technical Specifications 7.1
Chattanooga Intelect F-SW USA
7-3
7.2
Type plate
7-4
7.3
Conformity with standards
7-4
Warranty and Service 8.1
Warrany for the Chattanooga Intelect F-SW USA
8-3
8.2
Warranty for the F-SW handpiece
8-3
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General Information
1
1-2
General Information
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1.1
Introduction
This manual contains warnings, safety instructions and specific operating instructions in accordance with liability regulations.
DANGER Refers to a situation of acute danger which, if not avoided, could lead to serious or fatal injury..
WARNING Refers to a situation of potential danger which, if not avoided, could lead to serious or fatal injury.
CAUTION Refers to a situation of potential danger which, if not avoided, could lead to minor injury.
ATTENTION Warns against possibly harmful situations that could lead to damage to either the product or to the surrounding area.
1-3 NOTE
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General Information
Additional information concerning specific features or operating instructions is preceded by the term “NOTE”.
CAUTION! Before you start using the Chattanooga Intelect F-SW USA for the first time, please make sure that you have read in full and understood all the information provided in this operating manual. Familiarity with the information and instructions contained in this manual is essential for ensuring efficient and optimal use of the instrument, for avoiding hazards to personnel and equipment and for obtaining good treatment results. Thorough knowledge of the information included in this manual will also enable you to react promptly and effectively in the event of malfunctions and errors. When using optional accessories, please also refer to the separate operating manuals for each of these accessories. It is imperative that users be familiar with the content of this manual before operating any part of this system.
The Chattanooga Intelect F-SW USA is a universal, compact shock wave unit that can be used for treatment involving medium- to high-energy electromagnetically generated shock waves.
General Information
1-4
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1.1.1 Indications The Chattanooga Intelect F-SW USA is indicated for extracorporeal shock wave treatment of heel pain due to chronic proximal plantar fasciitis for patients of age greater than 18 years with a history of failed alternative conservative therapies for at least six months. Chronic proximal plantar fasciitis is defined as traction degeneration of the plantar fascial band at the origin on the medial calcaneal tuberosity that has persisted for six months or more.
1.1.2
Contraindications
–– Over or near bone growth center until bone growth is complete –– When a malignant disease is known to be present in or near the treatment area –– Infection in the area to be treated –– Patient has a coagulation disorder or taking anti-coagulant medications –– Patient has a prosthetic device in the area to be treated –– Over ischemic tissue in individuals with vascular disease
1.1.3
Warnings
Treatment using the Chattanooga Intelect F-SW USA should be performed by a physician or licensed medical professional under the direct supervision of a physician who is trained and experienced in the care of patients with foot and ankle and/or lower extremity disorders and who has completed a training course on the use of the Chattanooga Intelect F-SW USA for treatment of heel pain due to chronic proximal plantar fasciitis. Patients may experience pain/discomfort during and after treatment. To minimize the potential for pain, the working pressure should be slowly increased to a level of 0.25 mJ/mm2 during the first 500 impulses. Treatment with analgesics may be appropriate.
1-5
Careful positioning of the patient is required to avoid damage to vascular and nerve structures in the treatment area if inadvertently treated with shockwaves.
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General Information
The Chattanooga Intelect F-SW USA may be sensitive to excessive electromagnetic emissions which could result in device malfunction. Do not perform procedures in close proximity to electrosurgery, diathermy or magnetic resonance imaging equipment.
1.1.4
Precautions
The safety and effectiveness of the Chattanooga Intelect F-SW USA has not been demonstrated in patients with the following conditions/observations: 1
Children less than 18 years of age
2
Inflammation of the lower and upper ankle
3
History of rheumatic diseases, and/or collagenosis and/or metabolic disorders
4
History of hyperthyroidism
5
Paget disease or calcaneal fat pad atrophy
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Osteomyelitis (acute, sub acute, chronic)
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Fracture of the Calcaneus
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Immunosuppressive therapy
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Long-term (≥ 6 months duration) treatment with any corticosteroid
10 Insulin-dependent diabetes mellitus, severe cardiac or respiratory disease 11 Coagulation disturbance and/or therapy with anticoagulants or antiplatelet agents that may prolong bleeding time 12 Bilateral painful heel, if both feet need medical treatment 13 Previous surgery of the painful heel syndrome 14 Previous unsuccessful treatment of the painful heel with a similar shockwave device 15 History of allergy or hypersensitivity to bupivacaine or local anesthetic sprays 16 Significant abnormalities in hepatic function
1-6
17 Poor physical condition 18 Pregnant female 19 History or documented evidence of peripheral neuropathy such as nerve entrapment, tarsal tunnel syndrome, etc. 20 History or documented evidence of systemic inflammatory disease such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, aseptic bone necrosis, Reiter‘s syndrome, etc. 21 Implanted pacemakers, insulin pumps, defibrillators and/or neurostimulators 22 Open wounds or skin rashes
General Information
23 Tendon rupture, neurological or vascular insufficiencies of the painful heel, as assessed using the SemmesWeinstein Monofilament test and the Ankle Brachial Index
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1.2
Symbols Operating manual must be observed!
Application unit of type B
Potential equalisation
F-SW handpiece connection Foot switch USB connection Ethernet connection
WEEE label
1-7 Wear hearing protection!
manufacturer
CSA certification
Fuse
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General Information
Electromagnetic interference may occur in the vicinity of instruments marked with this symbol.
1.3
Requirements for operating the Chattanooga Intelect F-SW USA
1.3.1
Operator
The Chattanooga Intelect F-SW USA is intended exclusively for use by healthcare professionals and may only be used by suitably qualified and trained medical personnel. Such a healthcare professional 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 1.1.1 Indications. The healthcare professional must have the basic physical and cognitive prerequisites such as vision, hearing and reading. Furthermore, the basic functions of the upper extremities must be guaranteed. The instrument is designed for a demographic target group between 18 and 65 years.
1.3.2
Training of the operator
Operators of the Chattanooga Intelect F-SW USA must have been adequately trained in using this system safely and efficiently before they operate the instrument described in this handbook. An introduction to the principles of operation will be provided by your dealer with reference to this operating manual. The operator must be instructed in the following points: –– Instruction in the operation and designated use of the instrument with practical exercises
1-8
–– Mechanism of action and function of the instrument and the energies delivered by it –– All component settings –– Indications for use of the instrument –– Contraindications and side effects of the therapy waves –– Explanation of the warning notes in all operating statuses –– Instruction in how to perform the functional checks
General Information
Further training requirements vary from country to country. It is the operator’s responsibility to ensure that the training meets the requirements of all applicable local laws and regulations. Further information on training in the operation of this system is available from your dealer. However, you can also contact the following address directly: DJO, LLC 1430 Decision Street Vista, CA 92081 USA T: +1 800 494 3395 E: [email protected]
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1.4
Description of controls and functional elements
1.4.1
Chattanooga Intelect F-SW USA
2
1
1
3
Monitor
Power indicator 3 Foot switch 2
4
connection F-SW handpiece connection
1
Potential equalisation
4
Fig. 1-1 Front view of Chattanooga Intelect F-SW USA 1
2
3
connection
4 5 2
not used
3
Mains connection
4
Mains fuse holder
5
Mains switch
6
USB connection
1-9
for USB stick, USB mouse, USB keyboard and medical printer 7
LAN/Ethernet connection for service personnel only
8
10
9
8
7
Fig. 1-2 Rear view of Chattanooga Intelect F-SW USA
6
Water supply connection
9
not used
10 Type plate
NOTE
–– USB memory stick which supports the USB V1.1 protocol –– PCL3-capable printer –– USB mouse –– USB keyboard The connected instruments must be approved as medical products in accordance with EN IEC 60601.
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General Information
The following instruments can be connected to the USB connection:
1.4.2
F-SW 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 into the body at the treatment zone that has been established by diagnosis.
1 2
3
4
1 2 3 4
Trigger button Clamping ring Fixing screws Coupling diaphragm
4
Fig. 1-3 F-SW handpiece 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 (see Chapter 4.1.2.1 Changing the stand-off device).
1-10
1.5
Use of stand-off devices
The penetration depth of the shock wave can be adjuted by using different stand-off devices
General Information
without stand-off device
with stand-off device I
with stand-off device II
Fig. 1-4 F-SW handpiece
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Depth of focal zone
Therapeutically effective penetration depth 5 MPa 0 - 125 mm
50 mm
35 - 65 mm
0 - 105 mm
30 mm
15 - 45 mm
0 - 90 mm
15 mm
0 - 30 mm
Fig. 1-5 Depth of therapeutical effect
Perform changing of the stand-off devices as described in Chapter 4.1.2.1 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), deformation of the surface in the coupling area or leaks.
1-11
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General Information
The stand-off should be replaced at least every 12 months.
1-12
General Information
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Installation Instruction
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2-2
Installation Instruction
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