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8-5

17 368 02 0320

Technical data, conformity and labelling

8.2

Type plate DUOLITH

SD1

8.3

Conformity with directives

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

8.4

Conformity with standards

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

Acc. to EN 60601-1

- Type of protection against electric shocks:

Protection class 1

- Application unit of type B

Equipment safety (“essential performance“) according to IEC 60601-1:2005 +
A1:2012 / EN 60601-1:2006 + A1:2013, 3rd edition:

1 The device shall be free from excessive pressure pulse energy

2 The device shall be free from incorrect display of energy levels

3 The device shall be free from unintentional shockwave release

are fulfilled.

The essential performance characteristics of the device cannot be affected by electro-
magnetic interference (EMI).

Содержание DUOLITH SD1 R-SW

Страница 1: ...Operating Manual DUOLITH SD1 Tower BT Published March 2020 Original language German Manufacturer Publisher STORZ MEDICAL AG Lohstampfestr 8 CH 8274 T gerwilen Switzerland Part No 19900 xxxx 29081 0002...

Страница 2: ...II 17 360 02 0320 Preface...

Страница 3: ...ntified 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...

Страница 4: ...d in Chapter 7 Accessories Chapter 8 Technical specifications contains the technical specifications for all modules and their handpieces Warranty conditions for the device and the handpieces can be fo...

Страница 5: ...y 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 m...

Страница 6: ...ons are highlighted by being written in CAPITAL LETTERS The description of operating procedures contains the necessary buttons or the expected displays in the text Cross references to other chapters C...

Страница 7: ...1 3 1 Overview of the entire system 3 2 3 2 Scope of supply 3 4 3 2 1 Unpacking the device 3 6 3 3 Installation 3 6 3 3 1 Correct positioning of the device 3 6 3 3 2 Mounting the handpiece holder 3 6...

Страница 8: ...5 Touch Screen operation 4 12 4 5 1 Password protection 4 12 4 5 2 Setting brightness and volume 4 14 4 5 3 Selecting the operating mode 4 14 4 5 4 Selecting treatment parameters 4 15 4 5 5 Loading i...

Страница 9: ...ngs 4 37 4 5 21 5 Exiting Visible Body 4 38 4 6 Operation with the Module F SW 4 39 4 6 1 Setting treatment parameters 4 40 4 6 2 Start up 4 42 4 6 3 Functional checks 4 42 4 6 4 Standard settings 4 4...

Страница 10: ...6 3 4 Reconditioning the VACU ACTOR 6 8 6 3 4 1 Preparation of cleaning 6 8 6 3 4 2 Cleaning 6 9 6 3 4 3 Disinfection 6 9 6 4 R SW handpiece overhaul 6 10 6 5 Fuse replacement 6 10 6 6 Maintenance an...

Страница 11: ...D1 8 2 9 2 Warranty of the handpieces 8 2 9 3 Warranty for the VACU ACTOR 8 2 9 4 Service 8 2 Ultrasound optional 10 1 10 1 Connecting the ultrasound probe 10 2 10 2 Switching on the ultrasound module...

Страница 12: ...XII 17 360 02 0320 Preface...

Страница 13: ...1 General Safety Information...

Страница 14: ...ted use the user must possess the necessary technical proficiency and knowledge of the operating manual The device is only allowed to be used for the applications described in Chapter 2 1 1 Indication...

Страница 15: ...edical 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 DUOLITH SD1 from the...

Страница 16: ...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 cle...

Страница 17: ...limited to 30 minutes 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 c...

Страница 18: ...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...

Страница 19: ...2 Principles...

Страница 20: ...a tightly localised area even in deeper tissue layers R SW waves by contrast are from a physical point of view classified as radial pressure waves The applied pressure pulse propagates radially withi...

Страница 21: ...pinatus or and the rotator cuff with or without calcifications Radial ulnar humeral epicondylitis tennis elbow golfer s elbow elbow tendinopathy Greater trochanteric pain syndrome GTPS Trochanteric te...

Страница 22: ...EDICAL DUOLITH SD1 is not permitted in the following cases Coagulation disorders haemophilia Use of anticoagulants especially Marcumar Thrombosis Pregnancy Cortisone therapy up to 6 weeks before first...

Страница 23: ...of operation will be provided by your STORZ MEDICAL dealer with reference to this operating manual and will be documented in the system logbook The operator must be instructed in the following points...

Страница 24: ...2 6 17 362 02 0320 Principles empty page...

Страница 25: ...3 System Description...

Страница 26: ...H SD1 device is modular Depending on its level of expansion the device includes the following modules 1 CONTROL module with touch screen 1 1 CONTROL module with integrated ultrasound unit 2 R SW modul...

Страница 27: ...4 5 6 7 8 3 10 9 1 Monitor 2 CONTROL module 3 Master switch 4 F SW module 5 R SW module 6 Mains connector with mains fuse holder 7 Voltage selector switch 8 Potential equalisation 9 Transport handle...

Страница 28: ...ual operating manual system logbook 3 Trolley CONTROL module with integrated ultrasound unit R SW module Ultrasound probe 9MHz R SW handpiece set R SW shock transmitters VACU ACTOR start kit Mains cab...

Страница 29: ...bottle Water bag User manual operating manual system logbook 6 Trolley CONTROL module F SW module F SW handpiece set Mains cables Gel bottle Silicone oil bottle Water bag User manual operating manual...

Страница 30: ...here is a fault the resulting contact voltage represents a risk of injury to the therapist and the patient Therefore always connect the potential equalisation connector of the DUOLITH SD1 in accordanc...

Страница 31: ...w and can be height adjusted To mount the handpiece holder Slide the end of the holding rod into the opening on the device column Fig 3 4 Opening for the holding rod Fig 3 5 Handpiece holder Slide the...

Страница 32: ...3 3 4 Electrical connection The device can be operated on a mains voltage of 230V or 115V ATTENTION Damage to the device may occur if the voltage setting on the device does not match the local mains v...

Страница 33: ...ct the mains cable to the mains connection on the rear of the device 1 Mains connector 1 Fig 3 10 Mains connector Insert the mains cable into the electrical socket 3 4 Transport Make sure there are no...

Страница 34: ...lightly from below Fig 3 12 Releasing the wheels Grip the device at the transport handle Fig 3 13 Transport handle Move the device carefully and slowly When selecting the transport pathway bear in mi...

Страница 35: ...vidual modules of the device are operated using the control module by means of a colour TFT LCD monitor with touch screen The control module has a standby on off switch with a check lamp Fig 3 18 2 Al...

Страница 36: ...ftware updates The printer must be authorised as a medical product acc to EN IEC 60601 The LAN is used as a connector for a DICOM capable network Connectors F SW module 1 USB for software update 2 Ble...

Страница 37: ...ing the touch screen or the display of the handpiece F SW SEPIA Here you can make the treatment settings as described in Kapitel 4 5 Touch Screen operation The shocks are triggered using the handpiece...

Страница 38: ...Refer to the application brochure for more details about treatment Fig 3 20 F SW handpiece without stand off device with stand off device I short with stand off device II long for 50 mm depth of foca...

Страница 39: ...g 3 22 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...

Страница 40: ...iciency than with the C ACTOR handpiece The C ACTORII handpiece makes it possible to mechanically adjust the therapeutic penetration depth This is possible by using an additional stand off device 1 st...

Страница 41: ...duce frequency 4 Increase frequency 5 Menu Input reverse display press 3 sec 6 Display energy 7 Nominal shock wave 8 Shock wave counter 9 Display frequency 10 Key combination with double function 11 T...

Страница 42: ...handpiece into the connector on the right of the F SW module a n 1 2 1 Locking screw 2 Hybrid Connector Fig 3 27 Connecting the handpiece Secure it using the locking screw The locking screw must be t...

Страница 43: ...he R SW module can be controlled in different ways depending on the configuration If the device is equipped with the CONTROL module it is operated using the touch screen 1 2 3 1 Touch screen 2 Checkla...

Страница 44: ...R SW handpiece contains all the control and display elements required for operating the device as a standalone unit Corresponding setting buttons can be used for selecting the treatment parameters The...

Страница 45: ...CTOR and MP200 D ACTOR 200 group of devices for radial and focused shock wave therapy and or for planar pulses and pressure pulses By using this handpiece it is possible to treat soft tissues using hi...

Страница 46: ...ure that the red dot on the socket is aligned with the red dot on the handpiece connector Gently pushing the plug into the connector will immediately lock the connection and will prevent the connector...

Страница 47: ...vice and to protect the following patients against comtamination Insert the transparent suction cup into the coupling at the end of the longer hose part There are suction cups in 4 different sizes to...

Страница 48: ...lug of the foot switch into the connector on the rear of the R SW module Pressing the connected foot switch allows the ultrasound image to be frozen saving a US image the image on the display can be t...

Страница 49: ...4 Operation...

Страница 50: ...dule Fig 4 1 Mains switch Standby button The standby checklamp lights up The start up screen is shown on the display Fig 4 2 Touch screen with graphical user interface 4 2 Operating the device using t...

Страница 51: ...y using the handpiece when using R SW or F SW SEPIA handpiece Corresponding setting buttons can be used for selecting the treatment parameters The indicator window shows which setting has been selecte...

Страница 52: ...reen function and a graphical user interface The user interface of the DUOLITH SD1 is divided into various areas for displaying different information Module selection Parameter selection Counter displ...

Страница 53: ...ssible to activate the corresponding operating mode in the module selection area The active module button is highlighted Fig 4 5 Module selection field Symbols Meaning Select ultrasound R SW mode Sele...

Страница 54: ...duce The set energy level is displayed Setting nominal SW value increase reduce The set number of shock waves is displayed Nominal SW value set to means SW limitation is switched off Set nominal frequ...

Страница 55: ...ACTOR Fig 4 8 Setting parameters operating mode VACU ACTOR Symbols Meaning Set intensity decrease reduce It can be selected from 1 to 5 Set time limit decrease reduce The set time limit is displayed...

Страница 56: ...by different frequency settings Sizes of suction cups Size XS Size S Size M Size L 4 4 3 Contact intensity and Skin Touch display You can track the contact intensity on a scale during the R SW treatm...

Страница 57: ...er the following notes ATTENTION Danger of inadvertent shock triggering Trigger shocks only when the handpiece is in contact with the intended treat ment zone Avoid accidental contact between the pati...

Страница 58: ...ss the corresponding markers to call up factory set or user defined indications for the various treatment zones The ORTHOPAEDICS menu contains an alphabetically sorted list of factory set or user defi...

Страница 59: ...elected Total number of shocks delivered by the respective handpiece data on monitoring software operating system hardware serial numbers and modification status Resetting coil and revision counter IN...

Страница 60: ...display is locked and can only be unlocked by entering the password Activate password protection Press several seconds on date and time field The following screen is shown Fig 4 11 Activate password e...

Страница 61: ...he following screen Confirm with h Your password is deactivated Forgot password If you forgot password press forgot password On the following screen you get a random code Fig 4 13 Forgot password Pass...

Страница 62: ...ngs will be reloaded 4 5 3 Selecting the operating mode Once the unit has been started the display automatically shows the last setting To select a different operating mode In the MODULE SELECTION fie...

Страница 63: ...TION field h The treatment is now carried out with the displayed values 4 5 5 Loading indications The device makes it possible to load the default settings defined by the manufacturer for typical indi...

Страница 64: ...the list Use the navigation bar on the right edge of the display to move within the list 1 1 Navigation bar Fig 4 17 List of stored indications Press the or button to scroll up or down or Call up a li...

Страница 65: ...of the shock transmitter or stand off device Use the and buttons to switch to the display of the previous or next element Press to switch to the treatment step overview Loading treatment steps Load th...

Страница 66: ...Saving indications In addition to the preprogrammed indications you can also save your own parameter presets as an indication Set the required parameters Press Press NEW INDICATION The dialog box for...

Страница 67: ...he indication is now copied and can be edited see Chapter 4 5 9 Editing indica tions 4 5 8 Deleting an indication Press The list of indications is displayed Select the indication that you want to dele...

Страница 68: ...d notes in the text box Save your text by pressing OK h The text appears in the overview window of the indication 4 5 9 2 Loading images and or videos Not only images but also videos can be loaded in...

Страница 69: ...ure or video is deleted from the indication 4 5 9 3 Creating deleting or editing treatment steps Press to create a treatment step A window with an onscreen keypad and text boxes is opened First select...

Страница 70: ...u bar The alphabetically sorted list of patient data is opened Fig 4 25 List of stored patient data Navigating in the list Use the navigation bar on the right edge of the display to move within the li...

Страница 71: ...02 0320 Operation Fig 4 26 Patient data In the TREATMENTS line press the button to call up details You can now see which parameters have been used for the patient s treatment Fig 4 27 Treatment param...

Страница 72: ...s opened Press to load an indication The loaded indication is displayed in the status bar next to the patient s name Fig 4 28 Indication has been loaded The treatment parameters of the first treatment...

Страница 73: ...entry by pressing 4 5 12 Exporting treatment data This function can be used to export treatment data to a USB memory stick as Excel readable files Ensure that your USB stick supports the USB V1 1 prot...

Страница 74: ...RESET button in the COUNTER READINGS field to set the display of applied shock waves back to 0 Fig 4 30 Counter readings h The display of the number of pulses and the energy output per treatment is re...

Страница 75: ...SB stick to the left slot USB A see Chapter 3 1 Control and functio nal elements of the Control Device Connect the handpiece to the Control Device Switch on the Control Device the update starts automa...

Страница 76: ...cation groups Press In the open menu list select the function Fig 4 31 Options Orthopaedics active You see the list of possible indication groups The symbol before an indication group indicates that i...

Страница 77: ...ing image data with DICOM DICOM Digital Imaging and Communications in Medicine is an open standard for transferring and saving patient and image data in a medical environment 4 5 19 1 DICOM configurat...

Страница 78: ...dical device and a doctor s surgery EDP system A file with the required patient master data will thereby be sent by the doctor s surgery program that is requesting the data The DUOLITH SD1 ultra reads...

Страница 79: ...your Administrator Fig 4 34 GDT configuration example 4 5 20 2 Sending receiving data or requests via GDT To start the GDT request press The DUOLITH SD1 reads in the patient data that were previously...

Страница 80: ...le Body Anatomy Atlas Visible Body is an interactive 3D atlas of the human body allowing all 3D models and animations of the body systems and regions of humans to be represented Treatment regions can...

Страница 81: ...320 Operation 4 5 21 1 Starting Visible Body To start the Anatomy Atlas press Fig 4 37 Visible Body home screen After starting Visible Body always the menu item is opened Fig 4 38 Menu selection of th...

Страница 82: ...id for the other menu items Available menu items Regions Systems Cross Sections Senses Muscle Actions 4 5 21 2 Submenu Select a region while touching the desired image of the menu Fig 4 39 Submenu Now...

Страница 83: ...by spreading with two fingers and they can be turned by touching with one finger Alternatively the following symbols on the screen upper left can be used Symbol Name move illustration to the right lef...

Страница 84: ...ed body part on the touch screen The desired body part will be colored blue An info box opens showing the name of the body part in Latin and the currently set language Fig 4 40 Detail view with info t...

Страница 85: ...creenshot It will be saved automatically under the currently opened patient data 4 5 21 4 Settings Press the symbol to open the settings The symbol can be found either in the lower right or the upper...

Страница 86: ...he lower right corner of the language selection window Now press at any area outside the settings area to switch back to menu 4 5 21 5 Exiting Visible Body To exit the program press on a module select...

Страница 87: ...ystem is switched off and then on again no further degassing takes place Check that the F SW handpiece is correctly positioned in the holder and that no stand off is fitted NOTE No F SW pulse triggeri...

Страница 88: ...s a malfunction during the test The device is blocked to prevent further treatments Immediately inform your responsible Service centre 4 6 1 Setting treatment parameters Set the treatment parameters i...

Страница 89: ...8 Hz 0 25 8 Hz 0 20 8 Hz 0 15 8 Hz 0 12 8 Hz 0 10 8 Hz 0 07 8 Hz 0 05 8 Hz 0 03 8 Hz 0 02 8 Hz 0 01 8 Hz Table 4 10 Setting the treatment parameters in F SW mode C ACTOR II Energy flux density in mJ...

Страница 90: ...Table 4 10 and Table 4 11 This frequency can be reduced manually Activate 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...

Страница 91: ...ely 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...

Страница 92: ...s is based on the medical opinion of the doctor administering treatment The maximum energy level used during treatment must not cause the patient undue pain under any circumstances Coupling the handpi...

Страница 93: ...e back in the handpiece holder after the treatment NOTE IIf a nominal value above 1 000 shock waves is selected e g 1 700 shock waves the device automatically triggers a safety stop at 1 000 shock wav...

Страница 94: ...dicates that Skin Touch is active Stand alone Version Switch on the DUOLITH SD1 using the main switch on the rear of the column Trigger shock waves by pressing the Trigger button on the handpiece Fig...

Страница 95: ...e range from 1 to 21 Hz in the Frequency selection box Activate the trigger button NOTE If the nominal shock value is 0 displayed as the stop only occurs at 19 999 shock waves 4 7 3 Functional checks...

Страница 96: ...ent 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 ch...

Страница 97: ...nd frequency see Chapter 4 5 4 Selecting treatment parameters OR Load an indication and administer the treatment according to the recommendations of the treatment parameters stored in the system see C...

Страница 98: ...tment in a dry state Blood cupping is not allowed Only perform treatment at healthy and intact skin Avoid hematoma pain and tissue damage Connect the suction cup into the coupling of the air hose see...

Страница 99: ...treated as long as the treat ment lasts 4 8 2 Using the Display When using the Display the preadjusted parameters can be varied See for this Chapter 4 4 Adjust the intensity the frequency and the tim...

Страница 100: ...4 52 17 364 02 0320 Operation...

Страница 101: ...5 Status Displays and Trouble shooting...

Страница 102: ...cknowledge message further treatment is possible once the water temperature has returned to permitted values F SW Water temperature above 40 C Acknowledge message further treatment is possible once th...

Страница 103: ...missing Charging unit not ready Acknowledge message Call your Service centre if the fault continues after a reset F SW CTU fault divider disconnected Charging unit not ready Acknowledge message Call...

Страница 104: ...e device before you carry out any maintenance work Fault description Possible cause Corrective action System does not work Power failure Defective mains fuse Defective mains plug Check the power suppl...

Страница 105: ...piece clean the guide tube and projectile overhaul the handpiece see Chapter 6 4 R SW handpiece overhaul Dismantle the R SW handpiece and remove the excess projectile Replace the handpiece Call your S...

Страница 106: ...5 6 17 365 02 0918 Status messages and trouble shooting empty page...

Страница 107: ...6 Cleaning Maintenance Overhaul...

Страница 108: ...tic procedures All parts which come into contact with the patient must be cleaned before and after each treatment Wipe down the device parts with a damp cloth For cleaning use a lukewarm dilute soluti...

Страница 109: ...ercent Hydrochloric acid 20 percent Sulphuric acid 20 percent Trichlorethylene Tetrahydrofurane Toluene NOTE The constituents listed here are non binding examples No claims are made regar ding the com...

Страница 110: ...hose connection on the DUOLITH SD1 is located on the rear of the module Fig 6 1 Water hose connection Confirm by pressing OK A progress display indicating that the water circuit is draining is display...

Страница 111: ...tion Rinse out the water bag 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 In order to ad...

Страница 112: ...l the device is ready and you are prompted to remove the water bag Push the lock on the tube connection and pull the tube out of the connection Confirm by pressing OK There might be air bubbles in the...

Страница 113: ...using a cleaning agent that is suitable for surface cleaning Disinfect the handpiece with an alcohol based disinfectant that is suitable for surface cleaning follow the manufacturer s instructions Fo...

Страница 114: ...Preparation of cleaning Choose a clean dust free workplace to perform the cleaning and disinfection Material required Make sure that the following objects and tools for cleaning and disinfection are a...

Страница 115: ...adhering dust by blowing with ionized air ATTENTION Avoid damaging the suction cup Sharp tools abrasive or strongly alkaline detergents solvents leaded benzine and carbon tetrachloride should not be...

Страница 116: ...is the overhaul kit which includes all required wear parts For overhauling the R SW handpiece please read he separate Operating Manual of the R SW handpiece 6 5 Fuse replacement The mains fuse holder...

Страница 117: ...t once a year The following checks should be performed to ensure that the DUOLITH SD1 operates safely 1 Earth leakage current test according to national regulations 2 Earth impedance test with mains c...

Страница 118: ...SW handpiece approx 5 million shocks for the handpiece approx 1 million shocks for the shock transmitters Prerequisite Every 1 million shocks the R SW handpiece should be overhauled see Chapter 6 4 R...

Страница 119: ...7 Accessories...

Страница 120: ...andpiece 19365 0001 V ACTOR ball V10 21348 V ACTOR II HF handpiece 19365 1001 Foot switch 10103 Suction cup set 26923 Suction cup XS 26912 Suction cup S 26913 Suction cup M 26914 Suction cup L 26915 S...

Страница 121: ...7 3 17 367 02 0320 Accessories Pressure sensors 18342 DUOLITH SD1 BT operating manual 29081 0002 NOTE Further information and ordering data for the transmitters are available from your dealer...

Страница 122: ...7 4 17 367 02 0320 Accessories...

Страница 123: ...8 Technical data conformity and labelling...

Страница 124: ...oltage trolley 120 VAC 230VAC Mains frequency 50 60 Hz Mains fuse T 6 3AH 250 VAC at 120 VAC mains input voltage respectively T 4 AH 250 VAC at 230 VAC mains input voltage Power consumption max 700 VA...

Страница 125: ...th of focus 50 mm Depth of focal zone min 35 65 mm Therapeutically effective penetration depth 5 MPa 0 125 mm Energy flux density 0 01 0 55 mJ mm2 F SW handpiece with stand off device I short Focus si...

Страница 126: ...abolic reflector Energy settings minimum typical maximum Energy flux density mJ mm2 0 03 0 76 1 24 Peak positive acoustic pressure MPa 18 44 78 Peak negative acoustic pressure MPa 12 20 23 Axial focus...

Страница 127: ...01 1 Acc to EN 60601 1 Type of protection against electric shocks Protection class 1 Application unit of type B Equipment safety essential performance according to IEC 60601 1 2005 A1 2012 EN 60601 1...

Страница 128: ...Group 1 The DUOLITH SD1 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 According...

Страница 129: ...a typical commercial or hospital environment Surges according to IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Mains power quality should be that...

Страница 130: ...ng to the transmitter manufacturer and d is the recommended safety distance in metres m The field intensity of stationary radio transmitters based on an on site inspection a should be less than the co...

Страница 131: ...d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 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 list...

Страница 132: ...8 10 17 368 02 0320 Technical data conformity and labelling 8 5 Certificates Fig 8 1 Declaration of conformity...

Страница 133: ...ntly attached to the following modules Trolley column 1 2 3 Label Name 1 Potential equalisation 2 Type plate UDI Unique Device Identification Barcode auf dem Typenschild zur maschinenles baren Identif...

Страница 134: ...ion unit of type B 2 F SW connection Table 8 2 Labelling F SW module right side R SW module 1 3 4 5 2 Label Name 1 Application unit of type B 2 Connection VACU ACTOR 3 Connection for R SW handpiece 1...

Страница 135: ...belling 1 2 Label Name 1 Connection USB 2 Connection foot switch Table 8 4 Labelling R SW module rear side F SW and R SW module 1 Label Name 1 It is essential to comply with the operating manual Table...

Страница 136: ...ame 1 It is essential to comply with the operating manual Table 8 6 Labelling R SW handpiece Packaging Label Name Ambient temperature during storage and transport Ambient air pressure during storage a...

Страница 137: ...9 Warranty and service...

Страница 138: ...cally void the warranty even before the end of the warranty period 9 2 Warranty of the handpieces For the warranty conditions of the handpiece please refer to the Operating Manual of the corresponding...

Страница 139: ...10 Ultrasound optional...

Страница 140: ...ng Manual Telemed Ultrasound device ATTENTION For ultrasound systems with checklamp If no handpiece is connected the checklampwill be orange 10 1 Connecting the ultrasound probe Telemed ultrasound The...

Страница 141: ...tch 2 Bild 10 3 Probe socket Insert the probe connector into the probe socket with the cable to the left Set the interlock switch upwards Bild 10 4 Connected probe To disconnect the probe connector Se...

Страница 142: ...dule see Chapter 3 7 6 Connecting the foot switch This makes it possible to freeze US images 10 4 Operating Manual Telemed Ultrasound device The Operating Manual for the Ultrasound device in writing i...

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