Storz DUOLITH SD1 R-SW Operating Manual
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Storz DUOLITH SD1 R-SW Operating Manual

Storz DUOLITH SD1 R-SW Operating Manual

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O
M
perating
anual
DUOLITH
SD1 R-SW
®
Rx only
BS.####
Part No. 19900.xxxx
Published: November 2020
Original language: German
Manufacturer / Publisher:
STORZ MEDICAL AG
Lohstampfestr. 8
CH-8274 Tägerwilen
Switzerland
32429.0002

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  • Page 1 DUOLITH SD1 R-SW ® Rx only BS.#### Part No. 19900.xxxx Published: November 2020 Original language: German Manufacturer / Publisher: STORZ MEDICAL AG Lohstampfestr. 8 CH-8274 Tägerwilen Switzerland 32429.0002...

  • Page 2: Table Of Contents

    Table of Contents General Safety Information Instructions for safe use 1.1.1 Designated use and operational safety. 1.1.2 Safety during treatment of the patient. Warning against damage Principles Physical principles Indications Contraindications Warnings and precautions Preconditions for operation 2.5.1 Operating personnel . .
  • Page 3 Operation Switching on Operating the device using the CONTROL module Operating the device over the handpiece Displays and symbols 4.4.1 Module selection . . 32 4.4.2 Parameter selection and counter readings. . 32 4.4.3 Contact intensity and Skin Touch display . .
  • Page 4 4.5.19.1 Starting Visible Body . . 59 4.5.19.2 Submenu . 60 4.5.19.3 Marking treatment regions . . 62 4.5.19.4 Settings . . 62 4.5.19.5 Exiting Visible Body . 63 Operation with the Module R-SW 4.6.1 Setting treatment parameters . . 64 4.6.2 Start-up .
  • Page 5 Technical data Type plate DUOLITH SD1 R-SW ® Conformity with standards 8.3.7 EMC guidelines and manufacturer’s declaration . . 83 Symbols and labels Warranty and service Warranty for the DUOLITH SD1 R-SW ® Warranty of the handpieces Warranty for the VACU-ACTOR Service Ultrasound (optional) 10.5...
  • Page 6 Preface Warning notes 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. DANGER! The source of the danger is stated here. These are the possible consequences! •...

  • Page 7: General Safety Information

    The device is only allowed to be used for the applications described in C hapter ndiCatiOns • Only perform treatments approved by STORZ MEDICAL AG! All status and error messages signaled during treatment must always be attended to without delay.

  • Page 8: Safety During Treatment Of 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! • The optional KARL STORZ foot switch must not be used in potentially explosive atmospheres according to classification AP as per IEC 60601. Protection against noise The noise level during administration of pulses is within the safe area.

  • Page 9: Warning Against Damage

    Risk of transmission of microorganisms! Disinfect the handpiece after each use! For information about this, see C hapter leaning aintenanCe Warning against damage 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.
  • Page 10 The system must only be connected to properly earthed and correctly installed shockproof sockets! Set-up and operation 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 8.3.7 eMC ’...

  • Page 11: Principles

    Principles Physical principles The DUOLITH SD1 R-SW is a compressed air–operated ballistic pulse generator. The ® pulses in the DUOLITH SD1 R-SW are generated with a precision ballistic mecha- ® nism in the handpiece. A projectile is accelerated by compressed air. The motion and weight of the projectile produce kinetic energy.

  • Page 12: Contraindications

    CAUTION! The precautions listed here are examples. No claims are made re- garding the completeness or unlimited validity of this list of precau- tions. Treatment with the STORZ MEDICAL DUOLITH SD1 R-SW is not permitted in the ® following cases: –...

  • Page 13: Preconditions For Operation

    An introduction to the principles 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: –...

  • Page 14: System Description

    System Description Overview of the system Fig. 3-1 Frontside complete 1 CONTROL module with touch screen and integrated ultrasound unit. (The ultrasound unit is optional and can be ordered with colour doppler processing.) 2 R-SW module 17 740 02 1120...
  • Page 15 Fig. 3-2 Backside complete 3 Monitor 4 CONTROL module 5 Master switch 6 R-SW module 7 Mains connector with mains fuse holder 8 Voltage selector switch 9 Potential equalisation 10 Transport handle 11 Handpiece holder 17_740_02_1120...

  • Page 16: Scope Of Supply

    Scope of supply Standard level Standard accessories – R-SW handpiece set – R-SW shock transmitters – VACU-ACTOR start kit – Mains cables – Gel bottle – User manual (operating manual, system logbook) – Ultrasonic (optional) Trolley & module CONTROL & mo- dule R-SW Table 3 -1 Scope of supply...

  • Page 17: Mounting The Handpiece Holder

    3.3.2 Mounting the handpiece holder The handpiece holder has storage locations for the following handpieces: from left to right: – VACU-ACTOR – R-SW 1 – R-SW 2 – V-ACTOR – US-Transducer Fig. 3-3 Storage locations The handpiece holder is fixed in place on the device with a clamping screw and can be height-adjusted to mount the handpiece holder •...

  • Page 18: Electrical Connection

    Fig. 3-6 Tightening the clamping screw 3.3.3 Potential equalisation connection The DUOLITH SD1 R-SW features a potential equalisation connection. ® • Connect one end of the potential equalisation cable to the PE connection on the DUOLITH ® SD1 R-SW and the other end to your PE connection. Fig.
  • Page 19 Fig. 3-8 Voltage selector switch Changing the mains voltage • Move the switch with a screwdriver until the required value matches the arrowmark. Fig. 3-9 Mains voltage set to US-Voltage • Adjust the fuse value of the mains fuse according to the selected mains voltage (see c 6.4 f hapter...

  • Page 20: Transport

    Transport • Make sure there are no objects on the device. • Remove the handpiece and, if supplied, the ultrasound probe and foot switch. • Disconnect the mains plug. • Remove the potential equalisation connector. ATTENTION! Incorrect handling during transport will damage the device! •...

  • Page 21: Description Of The Control Module

    Fig. 3-13 Transport handle • Move the device carefully and slowly. • When selecting the transport pathway, bear in mind the limited ground clearance of the device as well as the dimensions for passageways. • Once the desired location has been reached, you can rotate the device into its final position using the positioning handle. Fig.

  • Page 22: Connectors

    3.5.2 Connectors 2 3 4 5 1 HDMI 2 USB1 3 USB2 4 USB3 (2.0) 5 Audio 6 LAN Fig. 3-16 Rear side - connectors control module Connectors Control module The USB connectors serve as an interface for data input and output. •...

  • Page 23: Description Of The R-Sw Module With Accessories

    Description of the R-SW module with accessories 3.6.1 Control and functional elements The R-SW module can be operated using the touch screen or during treatment from the handpiece. 1 Touch screen 2 Checklamp 3 R-SW module Fig. 3-18 Front of R-SW module with CONTROL 1 Mains switch 2 R-SW module Fig.

  • Page 24: R-Sw Handpiece

    3.6.2 R-SW handpiece Radial, low-energy shock waves (R-SW) are administered into the body by means of a freely movable handpiece, and encompass the entire pain zone. Radial shock waves are often also referred to as radial pressure waves – which is indeed physically correct. The handpiece is placed on the pain zone that has been established by diagnosis.

  • Page 25: V-Actor

    3.6.3 V-ACTOR The V-ACTOR is a “vibration therapy” handpiece and can be used as an optional ac- cessory with the DUOLITH 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 high-frequency pulses. 1 Trigger button 2 Shock transmitter Fig.

  • Page 26: Connecting Handpieces

    3.6.4 Connecting handpieces The R-SW module has four connectors. These are located on the right side of the device. VACU-ACTOR connection 2 u. 3 Connection for R-SW handpieces Connection for V-ACTOR Fig. 3-23 Connection for the handpieces and the VACU-ACTOR •...

  • Page 27: Connecting Vacu-Actor

    3.6.5 Connecting VACU-ACTOR 1 Coupling silicone hose 2 Hose 3 Coupling for connection the suction cup 4 Suction cup 5 Bacteria filter size relationships are not real Fig. 3-25 Connection VACU-ACTOR NOTE Immediately after the device output a one-sterile filter is used to avoid contamina- tion of the device and to protect the following patients against comtamination. •...

  • Page 28: Connecting The Foot Switch

    US image); the image on the display can be traversed again once the foot switch is released. Treatment with the VACU-ACTOR can be activated and deactivated with the aid of the foot switch. Fig. 3-27 Optional Storz foot switch 17 740 02 1120...
  • Page 29 Operation Read C 1 1 g before beginning treatment. hapter eneral afety nfOrMatiOn Switching on • Switch the device on using the main switch on the back of the column (Fig. 4-1). • Press the Standby button on the CONTROL module. Fig.
  • Page 30 Operating the device using the CONTROL module The individual modules of the device are operated using the CONTROL module by means of a colour TFT LCD monitor with touch screen. For more information about touch screen operation, refer to 4.5 t OuCh Creen Operati Operating the device over the handpiece...
  • Page 31 Displays and symbols The DUOLITH ® SD1 R-SW is operated using a colour TFT LCD monitor with touch screen function and graphical user interface. The user interface of the DUOLITH SD1 R-SW is divided into various areas for ® displaying different information. Menu bar: Monitor Monitor Counter...
  • Page 32 4.4.1 Module selection The field at the top left is used for displaying the operating modes that can be select- ed. Once a module is connected, it is possible 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 (optional) R-SW mode: Select handpiece 1 R-SW mode: Select handpiece 2 Vibration therapy: Select V-ACTOR Suction cup therapy: Select VACU-ACTOR...
  • Page 33 Symbols Meaning Set the energy level: increase / reduce 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 frequency: increase /...
  • Page 34 Operating mode VACU-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. Maximum adjustable time limit is 30 minutes. Set nominal frequency: decrease / reduce...
  • Page 35 Explanation of terms Mode VI The suction cup creates an interaction of vacuum and positive pressure with the adju- sted frequency. Mode VC The suction cup creates a negative pressure. It pulsates between vacuum and ventila- tion by different frequency settings. Sizes of suction cups Size XS Size S...
  • Page 36 For this purpose consider 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 patient and the handpiece when the Skin Touch function is activated.
  • Page 37 4.4.4 Treatment menu bar Use the TREATMENT menu bar to call up stored treatment parameters and treat- ment reports as indications. Fig. 4-10 Treatment menu bar Buttons Meaning Markers for various The ANATOMY view appears automatically when the treatment zones device is started.
  • Page 38 4.4.5 Device info and settings menu bar The bottom navigation bar contains control buttons used for navigating through the menus: – Software update – Options – Service VERSIONS – Serial number and indices of the individual components OPERATING DATA – Total pulse count and device operating hours (depending on operating mode selected) –...
  • Page 39 Activate password protection • Press several seconds on date and time field – The following screen is shown. Fig. 4-11 Activate password entry • Press to activate password entry (the check mark needs to be set after that). • Press • Type now your password on the following screen and repeat it. Fig.
  • Page 40 Forgot password? If you forgot password, • press “forgot password“. On the following screen you get a random code. Fig. 4-13 Forgot password • Pass this random code to the Service. Using this random code the service technician can generate a new password. •...
  • Page 41 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 field, press the operating mode you want to activate. – The active mode button is highlighted. Fig.
  • Page 42 4.5.5 Loading indications The device makes it possible to load the default settings defined by the manufacturer for typical indications. You can also add your specific settings for these indications if you wish. Read about this in C 4.5.6 s hapter aVing indiCatiOns To load all indications • Press in the top menu bar. – The alphabetically sorted list of all indications is opened. Fig. 4-16 List of stored indications To load only the indications for a particular treatment zone •...
  • Page 43 Navigating in the list Use the navigation bar on the right edge of the display to move within the list. 1 Navigation bar Fig. 4-18 List of stored indications • Press the button to scroll up or down. • Call up a list filtered by initial letters by selecting the corresponding letter pairs. •...
  • Page 44 • Press the underlined shock transmitter. – The display shows an image of the shock transmitter. Use the buttons to switch to the display of the previous or next element. • Press to switch to the treatment step overview. Loading treatment steps •...
  • Page 45 4.5.6 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 indications is opened. Fig. 4-21 Creating a new indication •...
  • Page 46 4.5.7 Copying indications A copy of a preprogrammed indication can also be created. The copy will then be provided with an additional number when it is saved and will contain all of the videos and images of the original indication. •...
  • Page 47 Fig. 4-22 New indication in editing mode 4.5.9.1 Storing treatment notes • To add remarks to the indication, press in the line. Using the onscreen keypad, you can now enter your remarks and notes in the text box. • Save your text by pressing h The text appears in the overview window of the indication.
  • Page 48 Fig. 4-24 New image or video • To change the label, press and enter your changes in the text box. • Save by pressing Deleting pictures and/or videos • To remove a picture or a video from the picture line, press on the symbol in the picture and confirm your entry with h The picture or video is deleted from the indication.
  • Page 49 Deleting a treatment step • Open the treatment step by pressing • Press to activate editing mode. • Press DELETE STEP. • Confirm your input by pressing 4.5.10 Patient treatment report Each treatment of a patient can be recorded in a treatment report and stored. 4.5.10.1 Loading patient data •...
  • Page 50 Fig. 4-27 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 treat- ment. Fig. 4-28 Treatment parameters used 17 740 02 1120...
  • Page 51 4.5.10.2 Editing patient data You can add additional notes or treatment pictures by setting the dataset to editing mode. • Press the button to do this. The buttons with the pencil icon indicate the areas that can be edited. You can now: –...
  • Page 52 4.5.11 Creating new patient data • Press in the top menu bar. – The alphabetically sorted list of patients is opened. • Press – A window with a keypad and text boxes for the patient data is opened. Fig. 4-30 Creating a new patient •...
  • Page 53 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 protocol. You can order a validated USB stick from your dealer. •...
  • Page 54 4.5.15 Software updates • Connect the USB stick to the left slot (USB-A, see C 3.5 d hapter esCriptiOn Of the ) of the Control Device. OntrOl MOdule • Connect the handpiece to the Control Device. • Switch on the Control Device - the update starts automatically. –...
  • Page 55 Fig. 4-32 DICOM configuration (example) 4.5.17.2 DICOM Worklist If a Worklist server is configured on your DUOLITH SD1 R-SW, then you can call up ® the active entries via 4.5.17.3 Saving/printing DICOM If a Store/Print server is configured on your DUOLITH ® , then you can use the Store and Print buttons in the Image Viewer to save or print individual pictures.
  • Page 56 Fig. 4-33 DICOM store / print 4.5.18 Data transfer via the GDT interface The GDT interface (Devices - Data - Transfer) is used as a standardised interface for data exchange between a technical medical 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.
  • Page 57 You obtain the GDT access data from your Administrator. Fig. 4-34 GDT configuration (example) 4.5.18.2 Sending/receiving data or requests via GDT • To start the ‘GDT request’, press The DUOLITH ® SD1 R-SW reads in the patient data that were previously made available by the doctor’s surgery system.
  • Page 58 Fig. 4-35 GDT request • To send the data of the doctor’s surgery EDP system, press The DUOLITH SD1 R-SW sends the supplemented data back to the doctor’s surgery ® system. Fig. 4-36 GDT transfer 4.5.19 Visible 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.
  • Page 59 NOTE The figures in this chapter are examples. The described actions work in all represen- tations. 4.5.19.1 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 the muscle regions •...
  • Page 60 – Systems – Cross Sections – Senses – Muscle Actions 4.5.19.2 Submenu • Select a region, while touching the desired image of the menu. Fig. 4-39 Submenu Now you can select or deselect body systems in the left column of the submenu screen.
  • Page 61 Symbol Name Skeletal Nervous Circulatory Respiratory Muscular Digestive Urinary Lymphatic Endocrine Reproductive Table 4 -9 Toolbar - left column in the submenu The illustrations can be moved to the right, left, up and down. They can be enlarged or reduced as well by spreading with two fingers and they can be turned by touching with one finger.
  • Page 62 You can select individual body parts by touching in the detail view. • Select a body part on the touch screen. – The desired body part appears blue. – An info box opens showing the name of the body part in Latin and the currently set language.
  • Page 63 Press the symbol to open the settings. The symbol can be found either in the lower right or the upper right corner of the touch screen. Fig. 4-42 Window - settings • Press switch to the language selection window. Fig. 4-43 Window - language selection •...
  • Page 64 Operation with the Module R-SW Touch Screen • On the display, select the button for the required handpiece in the ‘Module selec- tion’ field, e.g. ATTENTION! Malfunction of the device or its components are possible. • Before starting treatment, it is essential to perform the f unCtiOnal CheCks described in C 4.6.3..
  • Page 65 4.6.2 Start-up • Set the energy of the shocks to an initial value of 2 bar The maximum pressure is limited to 5.0 bar . The minimum pressure that can be set is 0.3 bar • Activate the trigger button. The R-SW handpiece can be operated in single shock mode and in continuous shock mode.
  • Page 66 4.6.4 Standard settings • Before each treatment, make sure that the shock counter is set to zero. NOTE Set the nominal value counter to the required value. The '-' symbol appears if zero is selected. The device then operates without a nominal value specification. R-SW • Start the R-SW treatment at a pressure of 2 bar and a frequency of 5 Hz.
  • Page 67 ATTENTION! Malfunction of the device or its components • Immediately comply with all status and error messages which appear during the treatment. CAUTION! Over extended periods, the noise of the shocks can be per- ceived as unpleasant! • Offer ear protection to the patient. •...
  • Page 68 Triggering shocks Once all necessary preparations have been taken, it is possible to start the treatment. • Make sure that the shock wave counter is at zero and a low energy level has been set. • Press the trigger button on the handpiece. –...
  • Page 69 4.7.1 Using the foot switch When using the foot switch to activate the VACU-ACTOR the treatment is carried out with intensity 3. The treatment will always be carried out with mode VI in which alternately an under- pressure and overpressure will be produced. •...
  • Page 70 Status and Troubleshooting Status messages CAUTION! Malfunction of the device or its components Various injuries are possible! • Immediately comply with all status and error messages which appear during the treatment. Specified number of shock waves Acknowledge message, further treatment is reached possible. Shock wave limit for current Shock wave limit for current handpiece handpiece reached reached.
  • Page 71 Trouble-shooting CAUTION! Unplug the mains cable from the device before you carry out any maintenance work! Fault description Possible cause Corrective action System does not work Power failure Check the power supply. Defective mains fuse Replace the fuses. Defective mains plug Replace the mains cable.
  • Page 72 Cleaning, Maintenance General information about cleaning Regular cleaning of the system ensures perfect hygiene and operation of the DUOLITH ® SD1 R-SW. CAUTION! Electrical hazard! Disconnect the device and the accessories from the mains before starting any cleaning and overhauling work! •...
  • Page 73 Modul R-SW 6.2.3 Cleaning the R-SW handpieces Regular cleaning ensures perfect hygiene and operation of the R-SW handpiece. The handpiece, in particular the shock transmitter, must be thoroughly cleaned and disinfected after each therapy session. CAUTION! • Disconnect the handpiece from the control unit before starting any cleaning or maintenance work.
  • Page 74 6.2.5 Cleaning the transmitters For changing and cleaning of the transmitters please read the separate perating r-sw anual Of the handpieCe 6.2.6 Reconditioning the VACU-ACTOR ATTENTION ! After each application of the device with the suction cup all reusable parts which have been in contact with the patient need to be cleaned and disinfected.
  • Page 75 6.2.6.2 Cleaning The suction cup made of polycarbonate has a pore-free surface so that dirt does not cling easily to it. • Wipe the suction cup with a soft tissue moistened with water (recommended is microfibre), never rub with a dry tissue! NOTE Never rub the suction cup with a dry tissue. For efficient cleaning we recommend using a non abrasive detergent suitable for polycarbonate.
  • Page 76 R-SW handpiece overhaul Shock waves are generated mechanically. Due to the effects of friction, the handpiece components are continuously exposed to mechanical stress, which will cause minor wear. NOTE The R-SW handpiece should be overhauled about every 1,000,000 shocks. This can be done quickly and easily by the user of the device.
  • Page 77 Repair work on defective devices must only be carried out by personnel suitably authorised by STORZ MEDICAL. Only original STORZ MEDICAL spare parts may be used for this purpose. The personnel suitably authorised can be from STORZ MEDICAL or be representatives of STORZ MEDICAL agencies and dealers.
  • Page 78 Service life Device The average expected service life (MTTF) according to IEC 60601-1:2005 + A1:2012 / EN 60601- 1:2006 + A1:2013 is: DUOLITH SD1 R-SW – approx. 15,000 operating hours ® R-SW handpiece – approx. 5 million shocks for the handpiece –...
  • Page 79 Accessories Accessories Mains cable US 16453 Drawer 23733 DICOM upgrade set I (up to Control Module SN): 0170) 23285 DICOM upgrade set II (up to Control Module SN): 0171) 23759 Accessories for R-SW module R-SW handpiece set 21700.1001 R-SW overhaul kit 26894 V-ACTOR 19365.0001...
  • Page 80 Technical data Technical data DUOLITH® SD1 R-SW single shock, continuous shock HP 21700.1001: 1-21 Hz / 0.3-5 bar operating mode R-SW operating mode V-ACTOR: - standard 31 Hz / 2.4 bar - when using an 1 - 50 Hz / 1.0 - 5.0 bar external display operating mode VACU-ACTOR: with foot switch:...
  • Page 81 R-SW handpiece Compressed air input 0.3 – 5.0 bar Ambient temperature during operation 10 – 40 °C Ambient temperature during storage and 0 – 60 °C transport Ambient air pressure 500 - 1,060 hPa Air humidity 5 – 95%, non-condensing Weight 510 g Protection against the ingress of water...
  • Page 82 Conformity with standards No. 601.1, This device complies with the applicable standards EN 60601-1, CAN / CSA-C22.2 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: Equipment safety (“essential performance“) according to IEC 60601-1, 3rd edition:...
  • Page 83 8.3.7 EMC guidelines and manufacturer’s declaration Guidelines and manufacturer's declaration – emitted electromagnetic interference The DUOLITH SD1 model is intended for operation in the electromagnetic environment specified below. The customer or the user of the DUOLITH SD1 should ensure that it is used in such an environment. The maximum length of the mains cable for the device is 3 m. Interference emission Compliance Electromagnetic environment –...
  • Page 84 Guidelines and manufacturer's declaration – Resistance to emitted electromagnetic interference The DUOLITH SD1 model is intended for operation in the electromagnetic environment specified below. The customer or the user of the DUOLITH SD1 should ensure that it is used in such an environment. IEC 60601 Compliance Electromagnetic environment – Immunity tests test level level guidelines...
  • Page 85 Guidelines and manufacturer's declaration – Resistance to emitted electromagnetic interference The DUOLITH SD1 model is intended for operation in the electromagnetic environment specified below. The customer or the user of the DUOLITH SD1 should ensure that it is used in such an environment. IEC 60601 Compliance Immunity tests Electromagnetic environment – guidelines test level level Portable and mobile RF equipment should be used no...
  • Page 86 Recommended safety distances between portable and mobile HF communications equipment and the DUOLITH SD1 The DUOLITH SD1 is intended for use in an electromagnetic environment in which radiated HF disturbances are controlled. The customer or the user of the DUOLITH SD1 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile HF communications equipment (transmitters) and the DUOLITH SD1 as recommended below, according to the maximum output power of the communications equipment.
  • Page 87 Symbols and labels The symbols and labels in this chapter are permanently attached to the following modules. Trolley column Label Name Potential equalisation Type plate UDI (Unique Device Identification): Barcode auf dem Typenschild zur maschinenles- baren Identifikation des Medizinproduktes It is essential to comply with the operating manual! WEEE symbol AEA Label...
  • Page 88 R-SW module Label Name Application unit of type B Connection VACU-ACTOR Connection for R-SW handpiece 1 Connection for R-SW handpiece 2 V-ACTOR connector Table 8 -12 Labelling R-SW module right side Label Name Connection USB Connection foot switch Table 8 -13 Labelling R-SW module rear side 17 740 02 1120...
  • Page 89 R-SW handpiece Label Name It is essential to comply with the operating manual! Table 8 -14 Labelling R-SW handpiece Packaging Label Name Ambient temperature during storage and transport Ambient air pressure during storage and transport Air humidity during storage and transport Table 8 -15 Labelling packaging 17_740_02_1120...
  • Page 90 Transport costs and the risk of loss during the shipping shall be borne by the customer. Please complete the attached warranty card and return it as soon as possible to the address below: STORZ MEDICAL AG Lohstampfestrasse 8 CH-8274 Tägerwilen ATTENTION ! Modifications to the device are not permitted.
  • Page 91 Ultrasound (optional) This chapter contains instructions for using the integrated ultrasound module of the DUOLITH SD1 R-SW. ® Please note that this section only describes how to connect the supplied ultrasound probe to the DUOLITH touch screen. For further information, please refer to the separate operating manual for the ultrasound device C 10.8 O hapter...
  • Page 92 Fig. 10-46 Connected probe To disconnect the probe connector • Turn the lock handle 1/4 turn anticlockwise as far as the stop. – The colour of the checklamp changes from green to orange. • Remove the probe connector from the socket. Telemed Smart US The probe connector is located on the left side wall of the control module.
  • Page 93 10.6 Switching on the ultrasound module • Switch on the DUOLITH ® SD1 R-SW using the main switch on the rear of the column. • Press the Standby button on the control module. • On the display, select the button in the ‘Module selection’ field. –...

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