Focus Shockwave Operating Manual - DJOglobal
Focus ShockwaveOperating Manual13 370 02 0518
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Table of ContentsGeneral Information1.1Introduction1.1.1Indications . . . . . . . . . . . . . . . . . . . . . . . 1-51.1.2Contraindications1.1.3Warnings . . . . . . . . . . . . . . . . . . . . . . . 1-51.1.4Precautions .1.2Symbols1-71.3Requirements for operating the Chattanooga Intelect F-SW USA1-81.3.1Operator1.3.2Training of the operator1.4Description of controls and functional elements1.4.1Chattanooga Intelect F-SW USA . . . . . . . . . . . . . . . . 1-91.4.2F-SW handpiece1.5Use of stand-off devices.1-3.1-51-6. 1-8.1-81-9.1-101-10Installation Instruction2.1Unpacking2-32.2Scope of supply2-32.3Installation2-42.3.1Handpiece holder installation . . . . . . . . . . . . . . . . . 2-42.3.2Installing the F-SW holding arm (optionally) 2-42.3.3Connecting power supply cables2.3.4Handpiece connection . . . . . . . . . . . . . . . . . . . 2-52.3.5Connecting the optional foot switch .2.3.6Potential equalisation (optional) . . . . . . . . . . . . . . . . 2-62.3.7USB connection . . . . . . . . . . . . . . . . . . . . . 2-62.3.8Transporting the instrument. 2-5. 2-6. . . . . . . . . . . . . . . . . 2-7Operation3.1General warnings and safety information3-33.2Operation3-63.2.1User interface . . . . . . . . . . . . . . . . . . . . . . 3-63.2.2Overview of menu functions . . . . . . . . . . . . . . . . . 3-103.2.3Starting the instrument .3-133.2.4Setting the treatment parameters . . . . . . . . . . . . . . .3-143.2.5Storing the treatment parameters . . . . . . . . . . . . . . .3-1513 370 02 0518.
3.2.6Loading treatment parameters . . . . . . . . . . . . . . . .3.2.6.1Pre-programmed indications from the manufacturer 3-173.2.6.2In-house applications .3.2.6.3Patient record . . . . . . . . . . . . . . . . . . . . .3-203.2.6.4Printing data* . . . . . . . . . . . . . . . . . . . . .3-233.2.6.5Data transfer3-243.2.7Software updates.3-263.2.7.1Loading the software onto the USB stick.3-263.2.7.2Updating the software on the instrument . . . . . . . . . . . . . 3-283.2.8Resetting the treatment shock counter . . . . . . . . . . . . . . 3-293.2.9“Autofrequency” function .3.3Start-up3-303.4Functional checks3-323.5Standard , Maintenance, Overhaul4.1Cleaning4-34.1.1Cleaning the instrument .4.1.2Cleaning the F-SW handpiece .4.1.2.1Changing the stand-off device . . . . . . . . . . . . . . . . . 4-44.1.2.2Reprocessing of the handpiece and the stand-off devices 4-54.1.2.3Cleaning . . . . . . . . . . . . . . . . . . . . . . . 4-54.1.2.4Disinfection4.1.3Cleaning the optional KARL STORZ foot switch 4-64.2Water renewal4.2.1Draining the water circuit . . . . . . . . . . . . . . . . . . 4-74.2.2Filling the water circuit4.2.3Bleeding the water circuit . . . . . . . . . . . . . . . . . . 4-114.2.4Resetting the water renewal time . . . . . . . . . . . . . . .4-114.3Fuse replacement4-124.4Maintenance and safety checks4-124.5Disposal4-134.6Repair4-134.7Service life4-134.7.1Service life of the handpiece . . . . . . . . . . . . . . . . . 4-13.4-3. 4-4. . . . . . . . . . . . . . . . . . . . . . 4-54-7. 4-913 370 02 0518
Status Messages and Trouble-shooting5.1Status essories6-3Technical Specifications7.1Chattanooga Intelect F-SW USA7-37.2Type plate7-47.3Conformity with standards7-4Warranty and Service8.1Warrany for the Chattanooga Intelect F-SW USA8-38.2Warranty for the F-SW handpiece8-313 370 02 0518
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General Information1
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1.1IntroductionThis manual contains warnings, safety instructions and specific operating instructions in accordancewith liability regulations.DANGERRefers to a situation of acute danger which, if not avoided, couldlead to serious or fatal injury.WARNINGRefers to a situation of potential danger which, if not avoided,could lead to serious or fatal injury.CAUTIONRefers to a situation of potential danger which, if not avoided,could lead to minor injury.ATTENTIONWarns against possibly harmful situations that could lead to damage to either theproduct or to the surrounding area.1-3NOTE13 371 02 0518General InformationAdditional information concerning specific features or operating instructions is preceded by theterm “NOTE”.
CAUTION!Before you start using the Chattanooga Intelect F-SW USAfor the first time, please make sure that you have read in fulland understood all the information provided in this operatingmanual.Familiarity with the information and instructions contained inthis manual is essential for ensuring efficient and optimal useof 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 theevent 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 manualbefore operating any part of this system.The Chattanooga Intelect F-SW USA is a universal, compact shock wave unit that can be used fortreatment involving medium- to high-energy electromagnetically generated shock waves.General Information1-413 371 02 0518
1.1.1 IndicationsThe Chattanooga Intelect F-SW USA is indicated for extracorporeal shock wave treatment of heelpain due to chronic proximal plantar fasciitis for patients of age greater than 18 years with a historyof failed alternative conservative therapies for at least six months. Chronic proximal plantar fasciitisis defined as traction degeneration of the plantar fascial band at the origin on the medial calcanealtuberosity that has persisted for six months or more.1.1.2Contraindications–– 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 disease1.1.3WarningsTreatment using the Chattanooga Intelect F-SW USA should be performed by a physician orlicensed medical professional under the direct supervision of a physician who is trained andexperienced in the care of patients with foot and ankle and/or lower extremity disorders and whohas completed a training course on the use of the Chattanooga Intelect F-SW USA for treatment ofheel pain due to chronic proximal plantar fasciitis.Patients may experience pain/discomfort during and after treatment. To minimize the potential forpain, the working pressure should be slowly increased to a level of 0.25 mJ/mm2 during the first500 impulses. Treatment with analgesics may be appropriate.1-5Careful positioning of the patient is required to avoid damage to vascular and nerve structures inthe treatment area if inadvertently treated with shockwaves.13 371 02 0518General InformationThe Chattanooga Intelect F-SW USA may be sensitive to excessive electromagnetic emissions whichcould result in device malfunction. Do not perform procedures in close proximity to electrosurgery,diathermy or magnetic resonance imaging equipment.
1.1.4PrecautionsThe safety and effectiveness of the Chattanooga Intelect F-SW USA has not been demonstrated inpatients with the following conditions/observations:1Children less than 18 years of age2Inflammation of the lower and upper ankle3History of rheumatic diseases, and/or collagenosis and/or metabolic disorders4History of hyperthyroidism5Paget disease or calcaneal fat pad atrophy6Osteomyelitis (acute, sub acute, chronic)7Fracture of the Calcaneus8Immunosuppressive therapy9Long-term ( 6 months duration) treatment with any corticosteroid10 Insulin-dependent diabetes mellitus, severe cardiac or respiratory disease11 Coagulation disturbance and/or therapy with anticoagulants or antiplatelet agents that may prolong bleeding time12 Bilateral painful heel, if both feet need medical treatment13 Previous surgery of the painful heel syndrome14 Previous unsuccessful treatment of the painful heel with a similar shockwave device15 History of allergy or hypersensitivity to bupivacaine or local anesthetic sprays16 Significant abnormalities in hepatic function1-617 Poor physical condition18 Pregnant female19 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 neurostimulators22 Open wounds or skin rashesGeneral Information23 Tendon rupture, neurological or vascular insufficiencies of the painful heel, as assessed using the SemmesWeinstein Monofilament test and the Ankle Brachial Index13 371 02 0518
1.2SymbolsOperating manual must be observed!Application unit of type BPotential equalisationF-SW handpiece connectionFoot switchUSB connectionEthernet connectionWEEE label1-7Wear hearing protection!manufacturerCSA certificationFuse13 371 02 0518General InformationElectromagnetic interference may occur in the vicinity of instruments markedwith this symbol.
1.3Requirements for operating the ChattanoogaIntelect F-SW USA1.3.1OperatorThe Chattanooga Intelect F-SW USA is intended exclusively for use by healthcare professionals andmay only be used by suitably qualified and trained medical personnel.Such a healthcare professional is expected to have practical knowledge of medical procedures andapplications as well as of the terminology, and should be experienced in treating the indicationsstated 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.1.3.2Training of the operatorOperators of the Chattanooga Intelect F-SW USA must have been adequately trained in using thissystem safely and efficiently before they operate the instrument described in this handbook. Anintroduction to the principles of operation will be provided by your dealer with reference to thisoperating manual.The operator must be instructed in the following points:–– Instruction in the operation and designated use of the instrument with practical exercises1-8–– 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 checksGeneral InformationFurther training requirements vary from country to country. It is the operator’s responsibility toensure that the training meets the requirements of all applicable local laws and regulations. Furtherinformation on training in the operation of this system is available from your dealer. However, youcan also contact the following address directly:DJO, LLC1430 Decision StreetVista, CA 92081USAT: 1 800 494 3395E: ChattProductSupport@djoglobal.com13 371 02 0518
1.4Description of controls and functional elements1.4.1Chattanooga Intelect F-SW USA2113MonitorPower indicator3 Foot switch24connectionF-SW handpiececonnection1Potential equalisation4Fig. 1-1 Front view of Chattanooga Intelect F-SW USA123connection4 52not used3Mains connection4Mains fuse holder5Mains switch6USB connection1-9for USB stick, USBmouse, USB keyboardand medical printer7LAN/Ethernetconnection for servicepersonnel only810987Fig. 1-2 Rear view of Chattanooga Intelect F-SW USA6Water supplyconnection9not used10 Type plateNOTE–– USB memory stick which supports the USB V1.1 protocol–– PCL3-capable printer–– USB mouse–– USB keyboardThe connected instruments must be approved as medical products in accordance with EN IEC60601.13 371 02 0518General InformationThe following instruments can be connected to the USB connection:
1.4.2F-SW handpieceFocused shock waves with a short wavelength that are concentrated on a focal zone outside thehandpiece are administered over the F-SW handpiece into the body at the treatment zone that hasbeen established by diagnosis.12341234Trigger buttonClamping ringFixing screwsCoupling diaphragm4Fig. 1-3 F-SW handpieceThe coupling diaphragm is fixed by a clamping ring and 3 fixing screws. It can only be opened fromauthorised personnel with special tools.The penetration depth of the shock wave can be varied by stand-off devices (seeChapter 4.1.2.1 Changing the stand-off device).1-101.5Use of stand-off devicesThe penetration depth of the shock wave can be adjuted by using different stand-off devicesGeneral Informationwithout stand-off devicewith stand-off device Iwith stand-off device IIFig. 1-4 F-SW handpiece13 371 02 0518
Depth offocal zoneTherapeutically effectivepenetration depth 5 MPa0 - 125 mm50 mm35 - 65 mm0 - 105 mm30 mm15 - 45 mm0 - 90 mm15 mm0 - 30 mmFig. 1-5 Depth of therapeutical effectPerform changing of the stand-off devices as described in Chapter 4.1.2.1 Changing the stand-offdevice.NOTEThe stand-off has a limited service life. It should be replaced if there are visible changes in thematerial (discolouration, tarnishing, streaks, gas bubbles), deformation of the surface in thecoupling area or leaks.1-1113 371 02 0518General InformationThe stand-off should be replaced at least every 12 months.
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Installation Instruction2
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2.1Unpacking Carefully remove the equipment 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/dealer immediately if any items are missing ordamaged. Retain the original packaging. It may prove useful for any later equipment transport.2.2Scope of supplyThe standard scope of supply of the Chattanooga Intelect F-SW USA:–– Chattanooga Intelect F-SW USA–– F-SW Sepia handpiece set–– handpiece holder–– Mains cables–– Gel bottle–– Silicone oil bottle–– Water bag–– User manual13 372 02 05182-3Installation InstructionPlease refer to chapter 6 Accessories for information on optional accessories.
2.3Installation2.3.1Handpiece holder installationThe 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 holders onto the right side wall of the Chattanooga Intelect F-SW USA,as shown in Fig.2-1/1.1Fig.2-1 Mounted handpiece holder2-42.3.2Installing the F-SW holding arm (optionally)To facilitate handling of the F-SW handpiece, you can hook the F-SWhandpiece onto the optionally available holding arm (Fig.2-3). Use a 2.5 mm Allen key for installation.Installation Instruction Screw the holder for the arm firmly onto the holes provided for it on the left of the instrument(Fig.2-2).Fig.2-2 Attachment holes for the holding arm Place the holding arm into the holder.13 372 02 0518
Fig.2-3 Holding arm attached2.3.3Connecting power supply cables Connect the Chattanooga Intelect F-SW USA via the mains cable to the mains connector (Fig.1-2/3).2.3.4Handpiece connection Connect the connector of the F-SW handpiece (Fig.2-4) to the handpiece connection providedon the Chattanooga Intelect F-SW USA and secure it using the black locking screw. The locking screw must be tightened up to the stop until finger-tight.2-5Fig.2-4 Connecting the F-SW handpieceNOTE13 372 02 0518Installation InstructionFill the water circuit of the Chattanooga Intelect F-SW USA first when the F-SW handpieceis first connected after delivery. The instrument will signal “water level too low” when it isswitched on.
2.3.5Connecting the optional foot switch Connect the connection cable of the foot switch to the appropriate connectionthe front side of the instrument.onNOTEThe foot switch is protected against ingress of water according to classification IPX8 as per IEC60529.2.3.6Potential equalisation (optional)The Chattanooga Intelect F-SW USA ifeatures a potential equalisation connection: Connect one end of the potential equalisation cable to the PE connection on the ChattanoogaIntelect F-SW USA and the other end to your PE connection.CAUTIONThe potential equalisation connection on the ChattanoogaIntelect F-SW USA must be connected in accordance with therelevant national regulations.2-62.3.7USB connectionThe USB connection (Fig. 1-2/6) acts as an interface for data input and output. Connect if required–– a USB memory stick which supports the USB V1.1 protocol–– a PCL3-capable printer–– a USB mouseInstallation Instruction–– a USB keyboardThe connected instruments must be approved as medical products in accordance with EN IEC60601.13 372 02 0518
2.3.8Transporting the instrumentATTENTIONThe 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-SWplug)To transport the instrument, grip the indentations on the side of the housing (Fig.2-5/1).2-7113 372 02 0518Installation InstructionFig.2-5 Indentations
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Operation3
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3.1General warnings and safety informationCAUTION !The Chattanooga Intelect F-SW USA iis intended exclusively foruse by medical specialists and may only be used by such suitablyqualified and trained medical personnel (see also chapter 1.3Requirements for operating the Chattanooga Intelect F-SW USA).The user is responsible for correctly positioning the handpiece ofthe Chattanooga Intelect F-SW USA.Correct determination of the location of the treatment zone is theresponsibility of the user.Only perform treatments approved by the manufacturer!To avoid safety hazards, use of the instrument for applicationsother than those specified in chapter 1.1.1 Indications is not allowed!Do not use the Chattanooga Intelect F-SW USA in potentiallyexplosive environments, i.e. in the presence of a flammableanaesthetic mixture with air or with oxygen or nitrous oxide.If instruments are connected that are not med
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
All Star Legacy Divas Junior Prep Level 2 17 73.3 3 3 3 Shockwave Allstars Intensity Junior Prep Level 2 21 71.9 4 NA NA Galaxy Allstars SuperNova Junior Prep Level 2 11 68.4 5 NA NA Shockwave Allstars Vortex Senior Prep Level 2 30 72.8 1 1 1 FAME Victorious Senior Prep Level 2 21 72.5 2 2 2 Shockwave Allstars Flare Junior Prep Level 3 22 72.35 .
5. Zoek naar 'Shockwave Flash Object' (een andere naam voor Flash Player) in de lijst met invoegtoepassingen. 6. Controleer in de kolom 'Status' of 'Shockwave Flash Player' is uitgeschakeld. Als dit het geval is klikt u op de rij 'Shockwave Flash Player'. 7. Klik in de rechter onderhoek van het dialoogvenster op Inschakelen. 8.
environmental information of the product in the Ecophon family Focus. The values presented in this EPD are represented for the following products: Focus A, Focus B, Focus C, Focus Ds, Focus Dg, Focus D/A, Focus E, Focus Ez, Focus F, Focus Lp, Focus SQ, Focus Flexiform Supplemental product inf
Ecophon Focus Fixiform E A T24 1200x600x20 Focus E Ecophon Focus Flexiform A A T24 1200x600x30 1600x600x30, 2000x600x30, 2400x600x30 Focus A Ecophon Focus Frieze A T24 2400x600x20 Focus A, Focus Ds, Focus Dg, Focus E Ecophon Focus Wing A T24 1200x200x5
CHAPTER 1 – THE BASICS AND GETTING STARTED WHAT IS SFXPC4.1.3? Figure 1: SFXPC4.1.3 Main Window SFXPC4 is a Windows program that interfaces with a ShockWave 2 Module via a USB 2.0 full speed (12MBits/s) interface. The USB cable is identical to most digital camera USB cables so it is very likely that you already have a suitable cable.
laser-induced shockwave propagates through to-be-deformed laminated functional materials and provides sufficient momen-tum to achieve the conformal assembly with the underlying μ-patterned flexible substrates. The shockwave arises when the incoming laser pulse irradiates an ablation layer above functional
two standard Group 24 batteries. † Shockwave’s built in battery charger uses 110v power, eliminating the need for expensive 220v wiring resulting in an installation savings of 80% or more. And, if your shop loses power, SHOCKWAVE-equipped lifts keep working. Available on select 7,000 to
The Question is, “Am I my brother’s keeper?” Am I My Brother’s Keeper, Bill Scheidler 4 Deuteronomy 25:5-10 – God challenges brothers to build up the house of their brothers. “If brothers dwell together, and one of them dies and has no son, the widow of the dead man shall not be married to a stranger outside the family; her husband’s brother shall go in to her, take her as his .
