Mindray ZS3 Instructions For Use Manual
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Mindray ZS3 Instructions For Use Manual

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ZS3 Ultrasound System
Instructions for Use
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Summary of Contents for Mindray ZS3

  • Page 1 ZS3 Ultrasound System Instructions for Use...
  • Page 2 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All other trademarks are the property of their respective holders. The ZS3 Ultrasound Platform and products derived there from (for example, but not limited to, the ZS3 and the z.one with and without the SP UI option) is covered by one or more of the following patents: 6,251,073;...

  • Page 3: Table Of Contents

    Contents Contents ............................III Intellectual Property Statement ......................IV Responsibility on the Manufacturer Party ..................IV Warranty ............................. V Exemptions ............................V Introduction ......................... 1 Getting Started ........................6 Imaging ..........................18 Transducers and Needle-Guided Brackets ................31 Transducers ............................31 Needle-guided Bracket ........................

  • Page 4: Contents

    Contents of this manual are subject to change without prior notice. All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this manual.

  • Page 5: Warranty

    FOR ANY PARTICULAR PURPOSE. Exemptions Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel.

  • Page 7: Introduction

    The ZS3 Ultrasound Platform and products derived there from (for example, but not limited to, the ZS3 and the z.onepro with and without the SP UI option) is used for ultrasound evaluation of the following applications: Laparoscopic, Fetal, Abdominal, Intra-operative, Pediatric, Ophthalmic, Small Organ/Parts (breast/testes, thyroid, etc.), Transvaginal,...
  • Page 8 Smart OB/NT AutoIMT Stress Echo Total Recall Protocol Needle OPT Anat Mmode TTQA Battery Pack ECG cable Barcode Reader USB Foot Pedal Ultrasound gel warmer assembly Including ultrasound gel warmer and bracket. ZS3 Instructions for Use P a g e...
  • Page 9 A type BF patient-applied part (B= body, F= floating applied part) A type CF patient-applied part (C= cardiac, F= floating applied part) Alternating current (AC) Direct current (DC) Date of manufacture Manufacturer ZS3 Instructions for Use P a g e...
  • Page 10 Waste Electrical & Electronic Equipment Standard Applies to EU Member States only: this system should not be treated as household waste. Mindray meets the WEEE Standard. For more information on returning or recycling this system, please contact Shenzhen Mindray Bio-Medical Electronics Co. or the distributor from whom you purchased the system.
  • Page 11 CE marking (0123) is the number of the EU-notified body certified for meeting the requirements of the Directive. MR Unsafe – the system is not intended to be used within magnetic resonance (MR) environment. ZS3 Instructions for Use P a g e...

  • Page 13: Getting Started

    Power button 2 USB Ports Multi-Transducer Port (MTP) Aux CW Port Connector One Front swivel lock Wheel Three wheels have a brake function Figure 2.1: ZS3 System Components P a g e ZS3 Instructions for Use...
  • Page 14 Full Screen Image Display (Figure 2.7) The ZS3 allows you to enlarge the imaging portion of the monitor to (1152 X 864). You can easily go from the imaging portion display of (960 x 720) to (1152 X 864) with the push of a...
  • Page 15 You can easily activate any of the transducers connected to the cart. Transducer Holders The Safe storage for transducers is provided on both sides of the ZS3 System (Figure 2.1). Internal Cart Solid State Drive (SSD) All exam images are initially archived to the Cart SSD.
  • Page 16 AC Power outlet. The backup is mounted at the base of the system and is automatically kept charged (as needed) whenever the ZS3 system is connected to active AC power Printers and Other Peripherals Mindray offers a number of optional medical-grade (IEC 60601 compliant) peripherals.
  • Page 17 Moving the ZS3 system Moving the System Lower the adjustable height to MINIMUM using the height adjustment release lever. Fold the monitor display down to a horizontal position and lock in place. The monitor arm will lock into a non-rotating position when the two parts of the articulating arm are in-line with each other AND centered with the system.
  • Page 18 User Interface and Onscreen Display Figure 2.4: Keyboard Figure 2.5: User Interface (See Section 3 Imaging for more details) 11 | P a g ZS3 Instructions for Use...
  • Page 19 Patient and Institution Information Image Image Area Parameters Menus OLEDs Trackball – Priority ICON Programmable Keys 12 | ZS3 Instructions for Use P a g e...
  • Page 20 2 Set Keys with labels indicating active state of keys • 1 Select Key with labeling indicating active state of key • 1 Pointer Key labeled • Trackball with center graphic indicating active state of trackball 13 | ZS3 Instructions for Use P a g e...
  • Page 21 The Help Bar displays help information items such as which button or control to press next to advance a function. This Bar is located to the right of the System ICONs. 14 | ZS3 Instructions for Use P a g e...
  • Page 22 To Power Off press and release the Power button. NOTE: When servicing the ZS3 system, always be sure to turn the circuit breaker to the Off position. Basic Measurements (Caliper Button) Press Caliper while image is frozen.
  • Page 23 Page Forward, Page Backward or First/Last on the QWERTY keyboard or OLEDs. Review and Delete Images using Thumbnails While in live scanning or Full Image with Thumbnail format, press the Pointer button. 16 | ZS3 Instructions for Use P a g e...
  • Page 24 Set. A prompt will ask to confirm. Click OK. To view the image in the image area, (Double Click) Set key. To return to live imaging, press Exit Review OLED Current Exam again. 17 | ZS3 Instructions for Use P a g e...

  • Page 25: Imaging

    Onscreen Trackball – Priority ICON is always available onscreen to alert the users of current functions. 18 | 18 | 18 | ZS3 Instructions for Use ZS3 Instructions for Use ZS3 Instructions for Use P a g e P a g e...
  • Page 26 Control designations are duplicated onscreen for easy reference (See Getting Started/User Interface and Onscreen display) 19 | 19 | 19 | ZS3 Instructions for Use ZS3 Instructions for Use ZS3 Instructions for Use P a g e P a g e...
  • Page 27 Pointer can be used to navigate onscreen thumbnails, adjust annotations and arrows as well. 20 | 20 | 20 | ZS3 Instructions for Use ZS3 Instructions for Use ZS3 Instructions for Use P a g e P a g e...
  • Page 28 (where user may apply color modes to one or both pane/s), and non- Simultaneous where different images may be displayed on each pane. 21 | 21 | 21 | ZS3 Instructions for Use ZS3 Instructions for Use ZS3 Instructions for Use P a g e P a g e...
  • Page 29 “Windowed”: HD Scope is presented as a window within a window. The main image within the HD Scope ROI remains unchanged. 22 | 22 | 22 | ZS3 Instructions for Use ZS3 Instructions for Use ZS3 Instructions for Use P a g e P a g e...
  • Page 30 Generally it should be compared with other devices or the diagnosis should be made using other imaging methods. 23 | 23 | 23 | ZS3 Instructions for Use ZS3 Instructions for Use ZS3 Instructions for Use P a g e P a g e...
  • Page 31 M-Mode Imaging. Pressing OLED #1 toggles through multiple pages of controls. 24 | 24 | 24 | ZS3 Instructions for Use ZS3 Instructions for Use ZS3 Instructions for Use P a g e P a g e...
  • Page 32 25 | 25 | 25 | ZS3 Instructions for Use ZS3 Instructions for Use ZS3 Instructions for Use P a g e P a g e P a g e...
  • Page 33 OLEDs to B-Mode without having to turn off Color Doppler or M Mode. 26 | 26 | 26 | ZS3 Instructions for Use ZS3 Instructions for Use ZS3 Instructions for Use P a g e P a g e...
  • Page 34 The optimization controls available in PDI, dPDI, and cTDI are generally the same as in CDV. 27 | 27 | 27 | ZS3 Instructions for Use ZS3 Instructions for Use ZS3 Instructions for Use P a g e P a g e...
  • Page 35 See the Spectral Doppler section (above) for details. CINE Controls The ZS3 Ultrasound System contains an Extended Cine buffer which does not ‘flush’ with mode changes, providing the user with access to data typically lost from the cine buffer when the user freezes the image or changes modes.
  • Page 36 Cine Select Chapter and Frame to last in the buffer • Playback speed to 100%. 29 | 29 | 29 | ZS3 Instructions for Use ZS3 Instructions for Use ZS3 Instructions for Use P a g e P a g e P a g e...
  • Page 37 Pressing this knob toggles between controlling the position and size of the Resp trace. Turning the knob changes the position or size. NOTE: Mindray recommends the following ECG patient cables and lead wires from Advantage Medical Cables (AMC) (www.advantagemed.com): 30 |...

  • Page 39: Transducers And Needle-Guided Brackets

    Mindray. Transducers NOTE (1): The ZS3 Ultrasound System is designed for compatibility with the following transducers. Because the availability of transducers is subject to government regulation and approval, some items included in the table may not be commercially marketed nor made available in your region of use.
  • Page 40 Peripheral vessel Vascular, Urology C6-2 Fetal, Abdominal Fetal, Abdominal Abdominal (includes (includes renal, (includes renal, renal, GYN/Pelvic), GYN/Pelvic), Pediatric, GYN/Pelvic), Pediatric, Contrast, Fetal, Peripheral vessel Peripheral vessel Pediatric, Peripheral Vascular, Urology 32 | P a g e ZS3 Instructions for Use...
  • Page 41 (Thyroid, Breast, Musculo-skel (Conventional)， Testes, etc.), Musculo- (conventional), Musculo-skeletal skeletal Musculo-skel (Superficial), Peripheral (Superficial), (Conventional)， vessel Pediatric, Peripheral Musculo-skeletal Vascular, Small (Superficial), Organ (Thyroid, Peripheral vessel Breast, Testes, etc), Urology 33 | P a g e ZS3 Instructions for Use...
  • Page 42 (Neuro), Pediatric, Pediatric, Peripheral operative (Neuro, Neonatal Cephalic, vessel abdominal, thoracic Adult (cardiac) and Cephalic/Transcranial, vascular (PV)), Cardiac Adult, Cardiac Neonatal Cephalic, Pediatric, Peripheral Pediatric, Peripheral vessel vascular, Contrast, Urology 34 | P a g e ZS3 Instructions for Use...
  • Page 43 Neonatal Cephalic, Urology E9-3 3D Fetal, Abdominal Fetal, Abdominal Abdominal (includes (includes renal, (includes renal, renal, GYN/Pelvic), GYN/Pelvic), Trans- GYN/Pelvic), Trans- Fetal, Trans-rectal, rectal, Trans-vaginal rectal, Trans-vaginal Trans-vaginal, 3D/4D, Contrast 35 | P a g e ZS3 Instructions for Use...
  • Page 44 Trans-vaginal rectal, Trans-vaginal Trans-vaginal, Contrast E9-4 Fetal, Abdominal Fetal, Abdominal Abdominal (includes (includes renal, (includes renal, renal, GYN/Pelvic), GYN/Pelvic), Trans- GYN/Pelvic), Trans- Fetal, Trans-rectal, rectal, Trans-vaginal rectal, Trans-vaginal Trans-vaginal, Contrast 36 | P a g e ZS3 Instructions for Use...
  • Page 45 Cephalic, Musculo- Musculo-skel Neonatal Cephalic, skeletal (superficial), Musculo-skeletal Neonatal Cephalic, (Conventional)， Pediatric, Peripheral (Conventional)， Musculo-skeletal Vascular, Small Musculo-skeletal (Superficial), Peripheral Organ (Thyroid, (Superficial), vessel Breast, Testes, etc), Peripheral vessel Contrast 37 | P a g e ZS3 Instructions for Use...
  • Page 46 Musculo-skeletal (conventional), Breast, Testes, etc.), (Superficial), Peripheral Musculo-skel Neonatal Cephalic, vessel (superficial), Musculo-skeletal Neonatal Cephalic, (Conventional), Pediatric, Peripheral Musculo-skeletal Vascular, Small (Superficial), Organ (Thyroid, Peripheral vessel Breast, Testes, etc), Contrast 38 | P a g e ZS3 Instructions for Use...
  • Page 47 Contrast, Fetal, Pediatric, Peripheral Pediatric, Peripheral Neonatal Cephalic, vessel vessel Pediatric, Peripheral Vascular, Urology P8-3TEE Trans-esoph. (non- Trans-esoph. (non- Transesophageal Card.), Trans-esoph. Card.), Trans-esoph. Echocardiography (Cardiac) (Cardiac) (non-cardiac and cardiac), Contrast 39 | P a g e ZS3 Instructions for Use...
  • Page 48 (Conventional), Musculo-skeletal (Superficial), Peripheral vessel P7-3c Fetal, Abdominal Abdominal (includes (includes renal, renal, GYN/Pelvic), GYN/Pelvic ), Cardiac, Cephalic, Pediatric, Neonatal Pediatric, Urology Cephalic, Adult Cephalic/ Transcranial, Cardiac Adult, Cardiac Pediatric 40 | P a g e ZS3 Instructions for Use...
  • Page 49 Laparoscopic Notes: For details about the P8-3TEE and P8-3mTEE transducers, please refer to the TEE transducer manual. For details about the C12-4lp transducer, please refer to the laparoscopic transducer manual. 41 | P a g e ZS3 Instructions for Use...

  • Page 50: Needle-Guided Bracket

    Needle-guided brackets are available for purchase as optional accessories and are used in combination with the probe. Some probes have corresponding needle-guided brackets and needles. To order needle-guided brackets, contact the MINDRAY Customer Service Department or a sales representative. For biopsy or treatment, ultrasound-guided biopsy procedures can be performed using the probe together with a needle-guided bracket (optional accessory) and a biopsy needle (provided by the user).
  • Page 51 Removing the Needle-Guided Bracket NGB-022 (1) Pull the lock pin and open up the V-shaped cover to expose the needle. (2) Separate the bracket and the transducer from the needle. 43 | ZS3 Instructions for Use P a g e...
  • Page 52 Press the OLED key assigned to Save to save the verified settings  Press the OLED key assigned to Restore to restore the factory default settings  Press the OLED key assigned to Verify or Exit to exit biopsy verify status 44 | ZS3 Instructions for Use P a g e...

  • Page 53: Tee/Laparoscopic Transducers

    TEE/Laparoscopic Transducers The ZS3 system will support laparoscopic imaging when used with the C12-4lp transducer, and TEE imaging when used with the P8-3 TEE and P8-3m TEE transducers. Refer to TEE Transducer and laparoscopic transducers for instructions on inspecting, cleaning, and maintaining the TEE and laparoscopic transducers.
  • Page 54 Figure 4-2: Adult TEE Transducer Handle and Scan Plane Adjustments Figure 4-3: Adult TEE Transducer Tip Deflection Controls 46 | ZS3 Instructions for Use P a g e...
  • Page 55 Anterior/Posterior tip deflection (120° +10ͦ ° up and 90° +10ͦ ° down). Both wheels have a friction lock and freely moving mode. Rotation Scan Plan Rotation Up/Down Figure 4-5: P8-3m Adult and Pediatric TEE Transducer Handle 47 | ZS3 Instructions for Use P a g e...
  • Page 56 Figure 4-6: P8-3m Adult and Pediatric TEE Scan Plane adjustment 48 | ZS3 Instructions for Use P a g e...
  • Page 57 • If the temperature reaches 42.7ºC the system will automatically freeze imaging. The transducer must be disconnected and allowed to cool off before additional imaging is supported. 49 | ZS3 Instructions for Use P a g e...
  • Page 58 The ZS3 organizes presets by transducer and by exam category. The exam type is a mechanism to filter the list of presets seen for any given transducer. The following table shows the exam categories supported for each transducer: (*Ophthalmic Imaging Note: Probes with an asterisk in the Small Parts column have been power adjusted [MI, TI, Ispta.3 limits] to provide for safe use during ophthalmic imaging.
  • Page 59 Small Transducer Abdominal Obstetrics Gynecology Vascular Cardiac Pediatric Urology Parts L30-8 P7-3c C12-4lp 51 | ZS3 Instructions for Use P a g e...

  • Page 60: Wearing The Probe Sheath

    Pull Poor imaging may result if no gel is used. cover tightly over probe acoustic lens to remove wrinkles and air bubbles, and taking care to avoid puncturing the sheath. 52 | ZS3 Instructions for Use P a g e...
  • Page 61 L10-5 106.5 43.3 1950±50 L20-5 24.1 1980±50 L8-3 100.1 56.3 27.9 1950±50 E9-3 3D 297.1 39.6 32.2 1950±50 E9-3 44.6 34.2 1950±50 E9-4 44.6 34.2 1950±50 P4-1c 35.2 28.6 1980±50 53 | ZS3 Instructions for Use P a g e...
  • Page 62 2025±50 P7-3c 33.4 26.5 1980±50 C12-4lp 66.5 2525±50 The above is a dimension illustration of the L14-5w probe. You can select the probe sheath according to the actual application situation. 54 | ZS3 Instructions for Use P a g e...

  • Page 63: Transducer Tracking

    Exam Date and Time the transducer was used. • Press the Setup key and select the System Button /Image Tab to display the Transducer Information on the image 55 | ZS3 Instructions for Use P a g e...
  • Page 64 • Press the Setup key and select the DICOM Set DICOM Service buttons to include the Transducer Information in the DICOM transfer. 56 | ZS3 Instructions for Use P a g e...

  • Page 65: Measurements And Calculations

    ‘fine tuning’ of caliper placement. o For example, if a ‘set’ of calipers is active while in Calcs or Caliper, pressing the Select button will ‘switch’ trackball control between the two calipers. 57 | ZS3 Instructions for Use P a g e...
  • Page 66 Measures the length of a curve. Distance (A/B) Ratio Measures the lengths of any two lines and calculates the ratio. Area Ratio Measures the areas of any two regions and calculates the ratio. 58 | ZS3 Instructions for Use P a g e...
  • Page 67 Velocity of two peaks on the Doppler spectrum are measured to calculate the ratio A/B. N intervals (n≤8) are measured to calculate a PW mode derived HR value in Beats Per Minute (BPM). 59 | ZS3 Instructions for Use P a g e...
  • Page 68 The interval size, and envelope type can be configured in Setup / System / Application / Auto- Trace or by adjusting the OLEDs assigned to the functions when Auto-Trace is active. 60 | ZS3 Instructions for Use P a g e...
  • Page 69 Caliper position may be modified after data is displayed according to the actual situation. 5. After Smart OB measurements are done, the result window will display the related data at the lower right corner of the screen. 61 | ZS3 Instructions for Use P a g e...
  • Page 70 If data onscreen needs to be adjusted, confirm the target profile manually and adjust the result. Select NT measurement and choose [Auto] method. AutoEF Function: Measure the diastole and systole planes automatically. 62 | ZS3 Instructions for Use P a g e...
  • Page 71 Note: Auto EF can also be launched using a programmable key when the image is live. When desired, press the Auto EF programmable key. The image will freeze and the above behavior will follow. 63 | ZS3 Instructions for Use P a g e...
  • Page 72 3, C6-2, C9-3, C8-3 3D, E9-3, E9-4, E9-3 3D, L10- 5, L8-3, L14-5sp, L14-5w, When angle ≤60º, ≤5%. Velocity (PW) L20-5, P8-3TEE, P9-3ic, C9-3sp, C6-1, C18-5, P8- 3mTEE, L30-8, C12-4lp, P4-1c, and P7-3c probes) 64 | ZS3 Instructions for Use P a g e...
  • Page 73 Parameter Range Error 10-200cm/s (for C10-3, C4- 1, P8-3TEE, P9-3ic, When angle ≤60, ≤5%. Velocity (CW) A2CW, A5CW, and P8- (not including pencil probe) 3mTEE, P4-1c, and P7-3c probes) 65 | ZS3 Instructions for Use P a g e...

  • Page 75: Annotations, Arrows, And Body Markers

    Pressing, toggling or turning OLED controls will briefly display the entire content of the list onscreen so users can quickly and easily find the text needed, even if out of order. 66 | ZS3 Instructions for Use P a g e...
  • Page 76 Arrows can be deleted by pointing to the arrow to be deleted and pressing the ‘Delete Arrow’ Sofkey OLED. • Pressing the UNDO button while Arrow is active will delete arrow in a last added/first deleted manner. 67 | ZS3 Instructions for Use P a g e...
  • Page 77 • Scrolling the trackball to the left for counterclockwise rotation; scrolling the trackball to the right for clockwise rotation. Changing Body Marker Library: • Sofkey OLEDs are used to change the Body Marker Library (Body Marker selections will change). 68 | ZS3 Instructions for Use P a g e...

  • Page 79: Archiving, Review And Management

    To avoid data loss, always use back up storage/archive devices. Do not delete patient data and images from the scanner until the backup has been completed and the ability to read transferred details is verified. 69 | ZS3 Instructions for Use P a g e...
  • Page 80 When this option has been selected, Total Recall data will automatically be loaded when images or clips are selected for Review • An OLED will then become available to ‘Exit TRI’ or ‘Delete TRI’. 70 | ZS3 Instructions for Use P a g e...
  • Page 81 Define the start and end point of a clip to re-save. Mark an image or clip to allow exporting or sending selective images. Format Toggle between multi image and full image with thumbnails format of Review. 71 | ZS3 Instructions for Use P a g e...
  • Page 82 From the Archive page, upon selecting an exam, a drop down menu will list options including but not limited to: • Review Images: Selecting this option loads the images for review • Patient Info: System is directed back to the Patient Data page 72 | ZS3 Instructions for Use P a g e...
  • Page 83 Collections can be used for teaching, credentialing, presentations, marketing etc. • The Image Gallery Function can be enabled in the Service menu • To create or add images to an Image Gallery, select desired images from Review 73 | ZS3 Instructions for Use P a g e...
  • Page 84 Image Gallery collections only for easy access • Image Gallery collections can be selected and then included in Slideshows on the ultrasound machine by checking the Slideshow Play onscreen button. 74 | ZS3 Instructions for Use P a g e...
  • Page 85 Wireless (Option) Mindray supports wireless connectivity using the Quatech Airborne Direct Wireless Ethernet Bridge. This is intended as a workflow enhancement to enable remote viewing and archival of data when a physical Ethernet connection is not available. It should not be relied upon however when time-critical diagnoses are required as multiple environmental factors may affect wireless connectivity performance.

  • Page 87: Advanced Features And Options

    Users should comply with relevant local regulations in terms of approved indications for use. NOTE: The ZS3 Ultrasound System is designed for compatibility with commercially available Ultrasound contrast agents. Because the availability of these agents is subject to government regulation and approval, product features intended for use with the agents may not be commercially marketed nor made available before the contrast agent is cleared for use.
  • Page 88 7. Exit contrast imaging. Press button to return to B mode. Figure 8-1: CEUS ABD imaging ZS3 Instructions for Use 77 | P a g e...
  • Page 89 When set to OFF, the Flash OLED will behave independently from the Store function. If the Flash OLED is pressed, the system will increase power to the image for the predetermined time set on the Flash OLED. Store must be manually pressed. ZS3 Instructions for Use 78 | P a g e...
  • Page 90 CEUS image on right to reference image on the left Frequency While CEUS Is active, pressing the Frequency button will change the frequency of the CEUS image. ZS3 Instructions for Use 79 | P a g e...

  • Page 91: Contrast Enhanced Ultrasound Quantification Imaging (Ceus-Qi)

    CEUS Imaging and affecting the CEUS image only. Pressing OLED #1 toggles through multiple pages of controls. ZS3 Instructions for Use 80 | P a g e...
  • Page 92 Push this dial to select Min or Max value for displayed Parameter. Turn the dial to change the value. • Reset the values to default by pushing the dial until Auto is displayed and turn the dial to toggle Auto to On. ZS3 Instructions for Use 81 | P a g e...
  • Page 93 Press this OLED to display the numeric data tables corresponding to the TIC. On/Off Exit Press this OLED to Exit CEUS QI. System returns to Review with the active clip loaded. ZS3 Instructions for Use 82 | P a g e...

  • Page 94: Elastography

    6. Click Save to complete the setting. Once configured, ARFI is invoked by pressing the configured function key. ARFI is available on the C4-1 transducer using a preset from the Abdominal Exam Category ZS3 Instructions for Use 83 | P a g e...
  • Page 95 Users can assign to a different segment iii. Users can ‘Enter’ the data point in the worksheet by pressing the “Enter Data’ OLED. Figure 8-2: ARFI with Liver Segment Selected ZS3 Instructions for Use 84 | P a g e...
  • Page 96 , kPa, m/s+kPa Units of measure: Control switches between kPa and m/s during an active exam. Delete Data User points to and clicks on ‘X’ onscreen, which removes a data point. ZS3 Instructions for Use 85 | P a g e...
  • Page 97 1. The values for ARFI velocity and stiffness are relative indices intended only for the purpose of comparison with other measurements performed using the CAUTION: ZS3. Absolute values for these measurements may vary among different measurement devices. This ARFI function is only used to measure objects larger than 10mm. If the object is smaller than 10mm, this function might not be reliable.
  • Page 98 Move and size the ROI using the Trackball and the Set keys i. 1-3cm below the liver capsule ii. Less than 10cm in depth and 30mm X 30mm in size ZS3 Instructions for Use 87 | P a g e...
  • Page 99 Select unit of measure to be displayed on 2D SWI color bar and Calcs Results Boxes. • m/s, kPa, or m/s+kPa m/s: Shear wave velocity Cs • kPa: Elastic Module (Young’s Module) M-STB Index Turn display of M-STB Index On and Off screen. On/Off ZS3 Instructions for Use 88 | P a g e...

  • Page 100: Tissue Tracking Quantitative Analysis (Ttqa)

    Select which view is to be evaluated using the View Type OLED Select desired Tracking Cycles (1 or 3) using the OLED Select which heart beat range will be evaluated using the Cycle OLED ZS3 Instructions for Use 89 | P a g e...
  • Page 101 Turns the arrow vector graphical display of the myocardial movement. Play/Pause Adjust to play/change playback speed or pause/move frame by frame Accept and Compute Press to Accept the trace; start the calculation, and display the curves. ZS3 Instructions for Use 90 | P a g e...
  • Page 102 AVC: displays aortic valve closure time. • MVO: displays mitral valve open time. • MVC: displays mitral valve closure time. • MVC’: displays mitral valve closure on the ending R wave ZS3 Instructions for Use 91 | P a g e...

  • Page 103: D & 4D Imaging With Advanced Lighting

    9. 3D & 4D Imaging with Advanced Lighting (Option) 3D/4D imaging is available on ZS3 when used with the C8-3 3D or E9-3 3D transducers. A Programmable Function key must be assigned to 3D in order to invoke 3D/4D imaging.
  • Page 104 (edit box appears) Softkey Label: Edit ROI Press Set to cycle box functionality: Position / Size / Cutline Postprocessng Mode See the pre-acquisition softkeys. Softkey Label: Render / MPR / Tomo ZS3 Instructions for Use 93 | P a g e...
  • Page 105 Press to switch the axes. Default is Volume with Z-axis Default Softkey: Softkey options: X-axis Y-axis Z-axis Can alternatively use these Major Mode buttons on the Control Panel: M = X-axis / D = Y-axis / C = Z-axis ZS3 Instructions for Use 94 | P a g e...
  • Page 106 0 / 1 / 2 / 3 / 4 / 5 Default is 3 Chosen option displays on Data Display Invert Toggles On / Off Inverts volume image to black on white ZS3 Instructions for Use 95 | P a g e...
  • Page 107 Post-processing modes ZS3 supports four post-processing modes: Render, Render with Light, MPR, and Tomo. Render Mode The imaging screen displays the surface volume image in a large format with the three orthogonal image planes in a small format. The volume image (V) is the active window by default.
  • Page 108 • *Thick Slice Mode: Integrates information along the z-axis to provide better contrast resolution. Maximum i n t e n s i t y and minimum intensity modes are supported. ZS3 Instructions for Use 97 | P a g e...
  • Page 109 Select reference image (one only) using softkey • Toggle between One-up and 9-up • Perform measurements on One-up image • Toggle slice lines' orientation from vertical to horizontal via softkey • ZS3 Instructions for Use 98 | P a g e...

  • Page 111: Needle Optimization Mode (For Improved Needle Visualization)

    Needle Opt Mode provides for improved needle visualization by adjusting system parameters to optimally receive echoes from needles. Needle Opt Mode is available on the ZS3 when using the L14-5w, L20-5, L10-5 and L8-3 transducers during B-Mode Imaging. Soft Keys (OLED)
  • Page 112 Figure 10-1 Optimum Needle Opt Setup Needle and dotted line of the shaded area form a 90 degree angle 100 | ZS3 Instructions for Use P a g e...

  • Page 113: Protocols

    Protocols are activated by pressing the Protocol key. The available protocols will be displayed on the screen. Select the appropriate protocol. Follow the onscreen prompts in the Help Bar to navigate through pre-defined protocol steps. 101 | ZS3 Instructions for Use P a g e...
  • Page 114 This control may be used to quickly continue a protocol any time a user selects views out of sequence to Repeat, Replace, Overwrite, or Delete views for instance. Protocols can be customized using the Setup/ Protocol tab. 102 | ZS3 Instructions for Use P a g e...

  • Page 115: Stress Echo

    2. Click to select Stress Echo to the desired key. 3. Click Save to complete the setting. Once configured, pressing the key assigned to Stress Echo (or pressing the Protocol Key) will 103 | ZS3 Instructions for Use P a g e...
  • Page 116 5. Proceed through each view in each stage according to the following instructions: 104 | ZS3 Instructions for Use P a g e...
  • Page 117 When the acquisition is ended, no additional stress echo image acquisition can be performed for the same exam. The following stages and controls are available while Stress Echo is active. 105 | ZS3 Instructions for Use P a g e...
  • Page 118 Suspend SE. If SE is suspended, pressing Protocol key or programmable key assigned to SE will re- enter exam Stress Echo protocols can be customized using the Setup/ Stress Echo tab. 106 | ZS3 Instructions for Use P a g e...

  • Page 119: Setup

    Enter the measurement settings (by exam type) and preferences including AutoTrace. OB Formula Enter relevant information regarding fetal gestational age, fetal growth formula and fetal weight Audio/Video Enter monitor, audio and external video settings 107 | ZS3 Instructions for Use P a g e...
  • Page 120 Enable auto completion, dual imaging annotation, and smart override mode. Define Lists Define the name, contents and order of pre-defined annotation lists that will be available for assignment to softkeys (OLED). Body Pattern Description of Control 108 | ZS3 Instructions for Use P a g e...
  • Page 121 Network Description of Control Network Configure network specifics including IP address, Gateway, Subnet Mask, MAC address Configure a wireless bridge. 109 | ZS3 Instructions for Use P a g e...
  • Page 122 Description of Control Backup/Restore To initiate a Backup or Restore of Presets and System data to and from a USB device. To restore factory defaults of Preset and System files. 110 | ZS3 Instructions for Use P a g e...

  • Page 123: System Security

    14. System Security System security features available on the ZS3 platform include Anti-Virus Scan, Secure Data Deletion, Patient Data Encryption, Password Protected User Accounts, Secure Network Transfers, and Backup to external media with Encryption. Anti-Virus The Anti-Virus scan feature is accessed under the boot_app display (press Service Key/ select Maintenance / select Service Reboot softkey to access the boot_app display).
  • Page 124 Password Protected User Accounts The ZS3 system supports password protected user login(s) which are cached on the system and unrecoverable if ‘lost’. At least one user must be assigned to the...
  • Page 125 Password Policy Config and follow onscreen prompts. To add or delete users; change passwords; or edit privileges, point to and select the appropriate button (highlighted in yellow box below) and follow onscreen prompts. 113 | ZS3 Instructions for Use P a g e...
  • Page 126 ZS3 and DICOM servers for added security. An alternative, less commonly used approach is to establish a Virtual Private Network (VPN) between the ZS3 and the DICOM server that do not offer TLS. Any communication between the two end points of a VPN is encrypted. Note that with TLS, ZS3 can communicate securely with multiple TLS-capable DICOM servers.
  • Page 127 Backup Exam Data to USB with Encryption The ZS3 system can be set up to encrypt patient exam data before backing up the data to removable media like USB. Select a patient exam from the Archive. Choose Backup Exam and select the appropriate external media as the destination.

  • Page 129: Maintenance

    If the transducer element is in malfunction, the dark stripes are displayed, as shown in the following left figure. If the transducer element functions well, no dark strips are displayed, as shown in the following right figure. 116 | ZS3 Instructions for Use P a g e...
  • Page 130 Each time a transducer is connected to the main system or activated, the users are recommended to implement probe check of transducer performance. System Care and Cleaning Before cleaning, turn off the AC circuit breaker on the ZS3 system to remove all power from the unit. To clean the LCD display: •...

  • Page 131: Safety

    ZS3 Ultrasound System and compatible transducers. Warnings • Do not use an aftermarket probe other than those specified by Mindray. The probes may damage the system causing a profound failure, e.g. a fire in the worst case. •...
  • Page 132 Mindray Technical Support. Failure to follow these restrictions may void your warranty or service contract coverage. • To reduce the risk of electric shock, DO NOT connect the ZS3 system input or output connections to equipment that is not properly connected to an Earth ground •...
  • Page 133 No modification of the system is permitted. Modifying the system may subject the operator or patient to hazardous conditions. • To reduce the risk of electric shock, do not connect the ZS3 input or output connections to equipment that is not properly connected to an Earth ground. •...
  • Page 134 If an external video monitor is connected to the ZS3 system, it is necessary to ensure that an RF ferrite is clamped to the cable as close to the ZS3 system as possible. Use a ferrite such as Fair- Rite Products Corp. 0431167281 (or an equivalent).
  • Page 135 Use only the recommended patient cable supplied by Mindray. Make sure that bare parts of the electrodes and the patient do not come in contact with conductive parts, such as metal examination beds, trolleys, and similar items.
  • Page 136 • Do not use other disinfection methods like Iodine, Steam, Heat or Ethylene Oxide. • When servicing the ZS3 System, always be sure to turn the circuit breaker to the OFF position. Precautions • Transducers are individually licensed according to system configuration. Only the following...
  • Page 137 • If the ZS3 System has been moved between environments with extremes of temperature and/or humidity, allow the ZS3 System to rest for at least 30 minutes in a controlled environment before using. • Do not use the ultrasound system if any error message displays on the screen.
  • Page 138 USB thumb drive before removing it from the ZS3 System. Failure to do so will result in loss of data. • Before deleting any Exam data from the ZS3 System, always verify that data was successfully transferred to USB thumb drive by viewing it on an external reader/player.
  • Page 139 Precautions - WIRELESS • WIRELESS: The Mindray Wireless option device is an RF Receiver and Transmitter, operating using industry standard 802.11 b/g protocols. Use of the wireless option, in the presence of other high energy RF radiating devices may interfere with the transmission of data to the network interfaces.
  • Page 140 European Norm (EN) and International Electronics Consortium (IEC) Harmonized St andards. • The transducers, when used with the ZS3 system, are certified to be in compliance with IEC 60601-1 as Type BF or Type CF applied patient parts. Each transducer or port is labeled accordingly.

  • Page 141: Acoustic Output

    For information about and possible bioeffects, refer to the Medical Ultrasound Safety ALARA 128 | ZS3 Instructions for Use P a g e...
  • Page 142 Default settings exist and are accessed whenever a transducer and mode combination is selected. Although the acoustic output associated with these defaults may differ from combination to combination, the default acoustic output is lower than 60601-2-37, 129 | ZS3 Instructions for Use P a g e...
  • Page 143 Frequency: Changing the operating frequency will affect the displayed MI and TI values as the beam formation is affected and transducer efficiencies may differ between frequencies. Image Presets: Changing the image presets may indirectly change the acoustic line 130 | ZS3 Instructions for Use P a g e...
  • Page 144 TI. Operating Frequency: Changing the operating frequency will affect both the displayed MI and TI values because the beam formation is affected and transducer efficiencies may differ between frequencies. 131 | ZS3 Instructions for Use P a g e...
  • Page 145 TI values because the beam formation is affected and transducer efficiencies may differ between f requencies. Image Presets: Changing the image presets may indirectly change the CW sensitivity. Increasing the sensitivity could change the TI values. 132 | ZS3 Instructions for Use P a g e...

  • Page 147: Display Accuracy And Precision

    The measurement uncertainty of quantities are listed in the table below. They are measured as part of determining MI or TI values. Quantities are listed as one standard deviation, in ZS3 Instructions for Use 133 | P a g e...
  • Page 148 Influenced by pressure wave amplitude and length, as well as pulse repetition frequency. Used in TI determination. Center Frequency (Fc) Center frequency (MHz) of an ultrasonic pressure wave. +/- 2% Used in TI and MI determination. 134 | ZS3 Instructions for Use P a g e...

  • Page 149: Guidance Documents

    NEMA UD 3. Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, Revision 2. National Electrical Manufacturers Association, American Institute of Ultrasound in Medicine, 2004. ZS3 Instructions for Use 135 | P a g e...

  • Page 151: Standards And Compliance

    - Requirements and tests. IEC 60601-2-37: 2015: Medical electrical equipment Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment issued by IEC in 2015. 136 | ZS3 Instructions for Use P a g e...
  • Page 152 30 cm (12 inches) to any part of the system, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. 137 | ZS3 Instructions for Use P a g e...
  • Page 153 Patient information; Date/time information. TABLE 1 GUIDANCE AND MINDRAY DECLARATION—ELECTROMAGNETIC EMISSIONS The system is intended for use in the electromagnetic environment specified below. The customer or the user of system should assure that it is used in such an environment.
  • Page 154 TABLE 2 GUIDANCE AND MINDRAY DECLARATION—ELECTROMAGNETIC IMMUNITY The system is intended for use in the electromagnetic environment specified below. The customer or the user of system should assure that it is used in such an environment. IEC 60601 COMPLIANCE ELECTROMAGNETIC...
  • Page 155 TABLE 3 GUIDANCE AND MINDRAY DECLARATION—ELECTROMAGNETIC IMMUNITY The system is intended for use in the electromagnetic environment specified below. The customer or the user of system should assure that it is used in such an environment. IEC 60601 TEST COMPLIANCE...
  • Page 156 If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the system. b Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m. ZS3 Instructions for Use 141 | P a g e...
  • Page 157 Name Cable length (m) Shield or not Remarks Power cable Not shielded ECG Lead Shielded Foot-switch control cable Shielded Probe cable <3.0 Shielded All probe cables SIP/SOP cable <3.0 Shielded ZS3 Instructions for Use 142 | P a g e...

  • Page 159: Product Labeling

    21. Product Labeling Contact Mindray if any of the labels are missing or damaged beyond legibility. The ultrasound labels herein are for reference only and are not shown to scale. With the ultrasound system, the L10-5 and L14-5sp transducers are classified as Type-CF (Cardiac Floating).

  • Page 161: Specifications

    Ethernet (1 port) RJ-45 – 10/100BaseT USB 2.0 (3 ports) USB-Type A (VBUS 5.0V, 0.5A max) External Video (1 port) HDMI 1280x1024 Serial port eSATAp Wireless Option Manufacturer B&B Electronics / Quatech ZS3 Instructions for Use 144 | P a g e...
  • Page 162 54Mb/s = -74 dBm 802.11 a 36Mb/s = -80 dBm 18Mb/s = -86 dBm 6Mb/s = -90 dBm Transmit Power 802.11b 15 dBm (31.6mW) 802.11g 12.6dBm (18.12mW) 802.11a 17 dBm (50.1mW) 145 | ZS3 Instructions for Use P a g e...
  • Page 163 Europe: CE ETSI EN300 328 RoHS & WEEE compliant Worldwide Certificate Support- FCC Part 15 Class B Sub C Modular Approval, IOC, CE, ETSI EN300 328, ETSI 60950-1, ROHS and WEEE Compliant ZS3 Instructions for Use 146 | P a g e...
  • Page 164 147 | ZS3 Instructions for Use P a g e...
  • Page 165 P/N: 046-012347-01 (3.0)

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