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Draminski FAST User Manual

Ultrasound scanner
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ULTRASOUND SCANNER
FAST
User manual
Edition 1.4 – 092022
0197

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  • Page 1 ULTRASOUND SCANNER FAST User manual Edition 1.4 – 092022 0197...
  • Page 2 DRAMIŃSKI FAST ULTRASOUND SCANNER User manual __________________________________________________________________________________________ Manufactured by: DRAMIŃSKI S.A. Wiktora Steffena 21 11-036 Sząbruk Poland Tel.: +48 89 675 26 00 ultrasound@draminski.com e-mail: www.medical.draminski.com Dramiński S.A. has established and maintains a full quality management system compliant with the requirements of EN ISO 13485:2012/AC:2012. The system is periodically reviewed along with the technical documentation by the notified body No.

  • Page 3: Table Of Contents

    ULTRASOUND SCANNER User manual __________________________________________________________________________________________ CONTENTS I. INTRODUCTION ...................... 4 II. EQUIPMENT ......................6 III. DESIGN OF DRAMIŃSKI FAST ULTRASOUND SCANNER ......... 6 Membrane keyboard and keyboard layout ............. 14 Screen layout ......................16 IV. PREPARATION FOR USE .................. 17 V.

  • Page 4: Introduction

    DRAMIŃSKI FAST ULTRASOUND SCANNER User manual __________________________________________________________________________________________ I. INTRODUCTION Information on this user manual This manual is intended to provide information to identify the technical properties of the scanner. It is written in an accessible way to make the information contained herein as useful as possible.
  • Page 5 (e.g. point-of-care testing, disaster medicine examinations, medical rescue teams - on-site examinations). DRAMIŃSKI FAST is a portable device intended for diagnostic use on people to carry out ultrasound examinations: - in intensive care and critical conditions including focused abdominal examination in trauma (FAST - focused assessment with sonography in trauma) and ultrasound lung examination;...

  • Page 6: Equipment

    FAST ULTRASOUND SCANNER User manual __________________________________________________________________________________________ II. EQUIPMENT List of components and standard equipment of DRAMINSKI FAST ultrasound scanner Description Quantity Scanner incl. LCD LED screen and membrane keyboard Mechanical probe (type as agreed with the supplier) Additional probe – to be agreed with the supplier Li-Ion battery pack 14.4 V / 3.1 Ah...
  • Page 7 DRAMIŃSKI FAST ULTRASOUND SCANNER User manual __________________________________________________________________________________________ Attention! The ultrasound scanner is of robust design. Nevertheless, be careful during the use and handling so as to avoid any strong impacts, which might lead to damage. Protect the probe connectors from dust or moisture.
  • Page 8 DRAMIŃSKI FAST ULTRASOUND SCANNER User manual __________________________________________________________________________________________ General view and description of casing components handle membrane keyboard LCD monitor with with monitor window LED backlight external memory connector to transfer images to the external memory via a special aluminium casing body...
  • Page 9 DRAMIŃSKI FAST ULTRASOUND SCANNER User manual __________________________________________________________________________________________ Rear casing wall with the battery pack connected ultrasound head detachable, external battery pack connectors battery pack fastening system system for fastening the battery pack to lock the casing DRAMIŃSKI ULTRASOUND SCANNERS...
  • Page 10 __________________________________________________________________________________________ 2. Ultrasound probe The probe (head) is an important part of the scanner. DRAMIŃSKI FAST ultrasound scanner is equipped with two ports and can operate with two types of mechanical sector probes at the same time: DA-90 abdominal sector probe 5.0 MHz (3-7 MHz), scanning angle: 90°...
  • Page 11 DRAMIŃSKI FAST ULTRASOUND SCANNER User manual __________________________________________________________________________________________ DR-360 endorectal sector probe 7.5 MHz (4-9 MHz), scanning angle: 180° Attention! Disposable probe covers must be used during examination. As the probe mechanism is technically advanced, appropriate care must be taken during operation and the probe needs to be protected from falling from significant height or from strong impact.
  • Page 12 DRAMIŃSKI FAST ULTRASOUND SCANNER User manual __________________________________________________________________________________________ Batteries The specially configured Li-Ion batteries form a pack including a thermal fuse to protect them from overheating during charging. The pack housing incorporates a socket for connecting the charger cable and dedicated openings for connection to the ultrasound scanner.
  • Page 13 DRAMIŃSKI FAST ULTRASOUND SCANNER User manual __________________________________________________________________________________________ 4. Charger An especially adapted 110-240 V / 50-60 Hz mains-powered charger is used to charge the batteries. The charger is equipped with cables and a colour LED to indicate the stage of the charging process.

  • Page 14: Membrane Keyboard And Keyboard Layout

    DRAMIŃSKI FAST ULTRASOUND SCANNER User manual __________________________________________________________________________________________ Membrane keyboard and keyboard layout The keys of the keyboard are arranged so as to facilitate the use of the ultrasound scanner during operation. Most of the keys are assigned specific functions to make access to various options and setting the picture parameters easier and faster.
  • Page 15 DRAMIŃSKI FAST ULTRASOUND SCANNER User manual __________________________________________________________________________________________ 1. open the main menu and accept the selected option or settings 2. confirm the marker position for dimensioning exit the menu and cancelling the change in parameter settings B Mode, B+B Mode B+M Mode. Keys to select the imaging mode...

  • Page 16: Screen Layout

    Screen layout Messages and information presented on the screen during the operation of the scanner An example of the FAST ultrasound scanner screen view with the picture frozen and description of messages and the information displayed: Information bar presenting the current settings: date and time, type of probe connected, G1 and G1 gain level, preset probe frequency, scanning range, zoom, refreshing (Fps), gamma level, picture freezing, battery status, results of measurements.

  • Page 17: Preparation For Use

    Carefully connect the round probe connector to the housing socket and tighten it while holding the metal part to ensure full and proper contact between the probe connector and the housing socket. DRAMIŃSKI FAST ultrasound scanner is equipped with two multi-pin sockets for probe connection.

  • Page 18: Menu Structure

    __________________________________________________________________________________________ V. MENU STRUCTURE Menu navigation rules The menu of the FAST ultrasound scanner is composed of two blocks, i.e.: Main menu opened with the button Additional menu opened with the key ; each menu contains several items with drop-down option lists.
  • Page 19 DRAMIŃSKI FAST ULTRASOUND SCANNER User manual __________________________________________________________________________________________ Settings Mode Presets Help Settings Mode Presets Help B Mode B+B Mode Range B+M Mode Gamma Zoom Negative Post-processing Full screen System > Left/right swap Date / Time the following Brightness parameters can be...

  • Page 20: Most Frequently Used Functions

    DRAMIŃSKI FAST ULTRASOUND SCANNER User manual __________________________________________________________________________________________ VI. MOST FREQUENTLY USED FUNCTIONS The table below includes the basic functions and those most frequently used during the operation of the ultrasound scanner and the keys to use the functions: The ultrasound scanner is turned off by pressing the ON/OFF Scanner button.

  • Page 21: Picture Freezing

    DRAMIŃSKI FAST ULTRASOUND SCANNER User manual __________________________________________________________________________________________ ADDITIONAL MENU /MEASUREMENTS/ Once the picture is frozen, the objects can be dimensioned using the navigation Measurements buttons by placing the marks and confirming their positions with OK button. This menu additionally includes the grid ON/OFF feature.

  • Page 22: Range - Penetration Depth Adjustment

    1 cm scale displayed at the bottom of the screen and next to the imaging sector. The ruler scale is automatically changed as the scanning depth changes. MHz – head frequency setting The FAST ultrasound scanner operates with broadband (multi-frequency) probes. The probe signal frequency can be changed simply and quickly using the navigation buttons.

  • Page 23: Negative

    This is the option of image presentation with reversed greyscale. This option is used less frequently. Post-processing – digital picture processing FAST ultrasound scanner is a compact but technologically advanced device. To optimize the picture quality and enhance its diagnostic value, an option of digital real-time processing of the picture being displayed and the frozen pictures or the pictures or cine loops loaded from the memory is available.

  • Page 24: Full Screen

    DRAMIŃSKI FAST ULTRASOUND SCANNER User manual __________________________________________________________________________________________ Full screen Once this option is selected and confirmed with "OK", the information bar is hidden and the imaging sector is displayed in full screen mode. Full screen view System - Settings This...
  • Page 25 DRAMIŃSKI FAST ULTRASOUND SCANNER User manual __________________________________________________________________________________________ Time and date setting dialogue box Brightness This is used to adjust the monitor screen brightness. Please note that the brightness level has an impact on the operating time of the batteries. The adjustment range is 10% to 100%.

  • Page 26: B+B And B+M Modes

    DRAMIŃSKI FAST ULTRASOUND SCANNER User manual __________________________________________________________________________________________ The following time periods can be set: never, after 5 min, 15 min, 30 min, 60 min. Sixty seconds before the automatic shut-off the following message will be displayed: “Auto power OFF, 60 seconds” and the system will start the countdown. The message disappears if any button is pressed and the system will restart the preset countdown time.
  • Page 27 DRAMIŃSKI FAST ULTRASOUND SCANNER User manual __________________________________________________________________________________________ B+B and B+M modes can be also activated by selecting the specific item in the main menu bar. B+B mode This option allows comparison of two pictures displayed on the screen at the same time. Once the B+B mode is activated, the screen will be divided into two windows (left and right window) and the picture will be frozen and moved to the right window.

  • Page 28: Cine Loop

    __________________________________________________________________________________________ Cine loop The FAST ultrasound scanner is equipped with a very useful feature of reviewing the examination results directly after completion of the examination. The "cine loop" option makes it possible to replay up to 256 frames before the picture was frozen.
  • Page 29 DRAMIŃSKI FAST ULTRASOUND SCANNER User manual __________________________________________________________________________________________ Measurements - Distance Once this option is selected, a red marker appears on the screen, which can be moved and set using the navigation buttons The position of the marker is confirmed by pressing "OK". Once the position is confirmed, another red marker appears which can be placed at an appropriate position and the distance between the two markers can be measured.

  • Page 30: Additional Menu - Management Of Pictures And Cine Loop

    DRAMIŃSKI FAST ULTRASOUND SCANNER User manual __________________________________________________________________________________________ Measurements - Clear By selecting this option measurements carried out previously will be deleted from the screen. This operation is performed to complete the dimensioning process. Additionally, the measurement results can be quickly cleared by pressing the “ESC" button.
  • Page 31 DRAMIŃSKI FAST ULTRASOUND SCANNER User manual __________________________________________________________________________________________ Save picture/cine To save a picture or a cine loop in the memory, the appropriate option needs to be selected in the additional menu and confirmed by pressing "OK". The picture (cine) will be automatically saved in the list and assigned to the next available number and a message with the number will be displayed shortly after the saving process is completed (saving the sequence of 256 frames takes approx.
  • Page 32 DRAMIŃSKI FAST ULTRASOUND SCANNER User manual __________________________________________________________________________________________ Searching the pictures and cine loops in the list Pictures and cine loops saved in the memory and specified in the list can be searched by a string of characters, provided that such a description was made when saving in the memory.
  • Page 33 DRAMIŃSKI FAST ULTRASOUND SCANNER User manual __________________________________________________________________________________________ Screen with highlighted picture or cine loop ready for transferring to an external drive After the "Send to USB" operation is confirmed, the data transfer process will be started and a corresponding message will be displayed in the centre of the screen indicating the transfer progress (which is the number of the frame being transferred or converted to AVI in case of a cine loop).

  • Page 34: Specifications

    Attention! If the storage temperature was lower than 5 ° C the head must be warmed up before the scanner is turned on. Operating the DRAMIŃSKI FAST scanner in extremely high and low temperatures is contraindicated and may lead to damage to the unit.

  • Page 35: Charging The Batteries

    The use of high-capacity batteries allows a long operating time (more than 4 hours). The battery level is indicated at the bottom of the screen of the DRAMIŃSKI FAST scanner. Shortening of the battery level bar and changing from green to yellow indicates an expected full discharge in about 1.5 hours.
  • Page 36 Attention! The charger is an auxiliary appliance to be used for charging the batteries only. It is not an integral part of Dramiński FAST ultrasound scanner to be used during operation. Attention! Connecting the charger to the battery pack attached to the ultrasound scanner will result in automatic disconnection of the power supply and prevent examination.

  • Page 37: Maintenance Of The Device And The Heads

    DRAMIŃSKI FAST ULTRASOUND SCANNER User manual __________________________________________________________________________________________ IX. MAINTENANCE OF THE DEVICE AND THE HEADS After a longer period of use, the appliance may become heavily contaminated also with contagious pathogens. Clean the instrument directly after use with a moist and soft cloth or a paper towel and a mild detergent.
  • Page 38 3. The battery is used up (a normal occurrence, resulting from the design and the operating principles of the battery). If none of the basic actions proves effective, please contact the repair shop at DRAMIŃSKI, tel. +48 89 675 26 00 or e-mail: info@draminski.com. DRAMIŃSKI ULTRASOUND SCANNERS...

  • Page 39: Safety Of Use

    14. Any modification of the scanner by the user is prohibited. 15. The DRAMIŃSKI FAST ultrasound scanner is an electrical appliance, which may be a source of electromagnetic radiation and its operation can be disturbed by other electrical devices.
  • Page 40 DRAMIŃSKI FAST ULTRASOUND SCANNER User manual __________________________________________________________________________________________ Guidelines and manufacturer's declaration - electromagnetic emissions The ultrasound scanner is intended for use in the electromagnetic environment described below. The owner or the user of the ultrasound scanner should ensure it is operated in such an environment.
  • Page 41 DRAMIŃSKI FAST ULTRASOUND SCANNER User manual __________________________________________________________________________________________ switching <5% U <5% U Quality of the power supply voltage overvoltages, short (>95% dip U ) for ½ of (>95% dip U ) for should be compliant with the interruptions and the period ½...
  • Page 42 DRAMIŃSKI FAST ULTRASOUND SCANNER User manual __________________________________________________________________________________________ Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidelines Portable or mobile radio frequency equipment including cables must not be used in the vicinity of the ultrasound scanner at a distance less than...

  • Page 43: Symbols And Designations Used On The Labels

    DRAMIŃSKI FAST ULTRASOUND SCANNER User manual __________________________________________________________________________________________ XI. SYMBOLS AND DESIGNATIONS USED ON THE LABELS CE mark indicating conformity of the product with the Medical Devices Directive certified by a notified body of TUV. 0197 BF type for parts in direct contact with the patient's body.
  • Page 44 DRAMIŃSKI S.A. Wiktora Steffena 21, 11-036 Sząbruk, POLAND tel. +48 89 675 26 00 e-mail: ultrasound@draminski.com www.medical.draminski.pl...

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