Instructions for Use
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ZONARE ZS3 Ultrasound System Instructions for Use
Instructions for Use ©2014 ZONARE Medical Systems Inc. All rights reserved. Printed in the USA. ZONARE, the ZONARE logo, ZS3 and z.onepro are all trademarks of ZONARE Medical Systems Inc. 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.onepro with and without the SP UI option) is covered by one or more of the following patents: 6,251,073; 6,569,102; 6,618,206; 6,663,567; 6,685,645; 6,733,455; 6,773,399; 6,866,631; 6,866,632; 6,896,658; 6,936,008; 6,980,419; 6,997,876; 7,022,075; 7,087,020; 7,226,416; 7,238,157; 7,352,570; 7,361,145; 7,510,529; 7,627,386; 7,382,309; 7,699,781; 8,002,705; 8,226,561; D461,814; D462,446; D467,002; D469,539; D469,877
ZONARE Medical Systems Inc. 420 N. Bernardo Avenue Mountain View, CA 94043 USA MedPass International Ltd. Windsor House Bretforton, Evesham Worcestershire, WR11 7JJ United Kingdom
Technical Support North America and Asia: Phone support: 1-877-913-9663 or 1-650-316-3199 Email: [email protected] Sales support: 1-877-966-2731, [email protected] www.zonare.com Europe: Phone support: +49 (913) 1974-9412 Email: [email protected] www.zonare.de CAUTION: United States Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner (USA).
Part Number Q00325-00 Rev H December 2014
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Table of Contents 1.
Introduction ... 5
Indications for Use ... 5 Device Description ... 5 Key to Symbols ... 6 2. Getting Started ... 10 Overview of Console, System and Features ... 10 Quick Start Guide... 13 Moving the ZS3 system ... 15 Height adjustment... 15 3. Imaging (Mode Controls) ... 16 2D/B-Mode Controls ... 16 M-Mode Controls ... 18 Color Doppler/Power Doppler Mode Controls ... 19 Strip Doppler Mode Controls (Pulsed Wave and Continuous Wave Doppler) ... 20 Physio Controls ... 21 Contrast, Elastography & 3D/4D (Options) ... 22 4. Transducers... 23 TEE Transducer (P8-3TEE) ... 29 5. Measurements and Annotation ... 32 Measurements... 32 Annotations... 34 6. Archiving and Review... 36 Image Print and Storage ... 36 Review ... 36 DICOM Connectivity... 36 Wireless (Option) ... 37 7. Advanced Features ... 39 Contrast ... 39 Elastography ... 40 8. 3D & 4D Imaging (Option) ... 41 Softkeys... 41 Menu Items ... 43 Post-processing modes ... 44 9. Maintenance... 47 User Diagnostic Panel... 47 System Care and cleaning ... 47
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10.
Safety... 49
Safety Standards ... 49 Warnings ... 49 Precautions ... 53 Electrical Safety ... 58 Contrast Imaging... 58 Medical Ultrasound Safety - General ... 58 11. Acoustic Output ... 59 ALARA Principle ... 59 Applying ALARA ... 59 Direct Controls... 60 Indirect Controls ... 60 Receiver Controls ... 61 General Controls ... 61 B-Mode Controls ... 62 M-Mode Controls ... 62 Color Doppler Controls ... 63 Color Doppler Triplex Controls ... 63 PW Doppler Controls ... 64 CW Doppler Controls ... 65 12. Transducers Performance ... 66 13.
Transducers: Acoustic Power Output ... 76
Ophthalmic Use ... 76 Acoustic Power Output Terms & Definitions ... 77 Symbols used in the tables ... 79 Acoustic Power Output Tables ... 79 14. Display Accuracy and Precision ... 140 15.
Guidance Documents ... 142
16.
Standards and Compliance ... 143
17.
Product Labeling ... 146
18.
Specifications ... 152
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1. Introduction United States Federal Law restricts this device to sale by or on the order of a licensed healthcare practitioner, licensed by the law of the jurisdiction in which they practice, to use or order the use of this device. Only qualified personnel should perform ultrasound scanning of human subjects for medical diagnostics. ZONARE ultrasound systems meet the acoustic output emission guidelines established by the U.S. Food and Drug Administration (FDA). Acoustic output quantities have been measured, and are displayed, in accordance with the standards listed under Guidance Documents.
Indications for Use This device is intended for use by a qualified physician for ultrasound evaluation of Ophthalmic; Fetal/obstetric, gynecological; Abdominal (renal, GYN/Pelvic; Intra-operative (abdominal, thoracic, and vascular), Intra-operative neurological; Pediatric; Small organ (thyroid, breast, testes, etc), Adult & Neonatal Cephalic; Trans-rectal, Trans-vaginal, Trans-cranial, Transesophageal (non-cardiac and cardiac); Musculoskeletal (conventional & superficial); 3D/4D; Cardiac – Adult/ Pediatric/ Fetal; Echo, Intra-Cardiac; Pelvic; Peripheral vascular; harmonic tissue and contrast imaging and Tissue elasticity.
Device Description The ZONARE 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: Fetal, Abdominal, Intraoperative, Pediatric, Ophthalmic, Small Organ/Parts (breast/testes, thyroid, etc), Transvaginal, Transrectal, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Tissue Elasticity, Contrast Imaging, Musculoskeletal, Superficial Musculoskeletal and Peripheral Vascular applications. Users include ultrasound imaging technicians (sonographers) and physicians. ZONARE Ultrasound Imaging Systems may be used in a hospital (e.g. imaging laboratory, emergency room, patient bedside, operating room), medical clinic, physician’s office or a mobile imaging center. The ZS3 Ultrasound Platform consists of two major components: 1) Cart; and, 2) Transducer(s). The Cart contains the software driven imaging electronics and user interfaces (keyboard, monitor, handles, etc.). It houses the microprocessor, memory, amplifiers and power supplies
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for the microprocessor. It sends electrical currents to and receives electrical pulses from the compatible ZONARE transducers. The Cart performs the calculations involved in processing the data to produce the displayed ultrasound images. Cart options include, but are not limited to, echocardiography (which includes continuous wave (CW), physiologic signals (ECG and respiration) and the cardiac calculation package), advanced vascular (which includes CW) and the streamlined Special Procedures user interface. Note: The availability of options may be limited based on country or region of use. Available with the system are one or more ZONARE Curvilinear, Endocavity, Linear, or Phased array transducers allowing for many clinical applications. Accessories include, but are not limited to the ZONARE ZPAK Battery and off-the-shelf components: bar code reader, foot pedal, printers, biopsy guides, ECG cables and a wireless Ethernet interface. Case studies can be stored to USB memory stick, DVD, and other industry standard archiving devices.
Key to Symbols The following symbols may be used in this document or elsewhere in product labeling. Symbol
Description Information that may relate to safety of the patient, the operator, or the equipment 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
Caution: ESD sensitive
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Description Recyclable material
V
Voltage
Hz
Cycles per second Waste Electrical & Electronic Equipment Standard Applies to EU Member States only: this system should not be treated as household waste. ZONARE meets the WEEE Standard. For more information on returning or recycling this system, please contact ZONARE Inc. or the distributor from whom you purchased the system. Consult the Instructions for Use
ZONARE serial number Authorized representative in the European Community Catalog number Shipping & Storage: Fragile
Shipping & Storage: Keep dry
Shipping & Storage: Temperature limits
Shipping & Storage: This side UP
Shipping& Storage: Do not stack above this container
Shipping & Storage: Humidity limits
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Description Shipping & Storage: Pressure limits
Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner (USA).
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2. Getting Started Please read this document carefully before using the ZS3 ultrasound system.
Overview of Console, System and Features
19 inch display
Speakers Gel Bottle Holder
Storage Bins
User Interface Control Panel height adjust
Cable management hooks Power button 2 USB Ports Bins
Multi-Transducer Port (MTP)
Aux CW Port Bins ECG Connector Bins Front Wheels (swivel lock orientation)
Figure 2.1: ZS3 System Components
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LCD Display The ZS3 full-sized 19-inch LCD Display shows the ultrasound image, plus patient and imaging information in designated areas of the screen.
Overall screen display = 1280 x 1024 pixels
Imaging area = 800 x 600 pixels
Full Screen Image Display The ZS3 allows you to enlarge the imaging portion of the monitor to use the full (1280 x 1024) display. You can easily go from the imaging portion display of (800 x 600) to (1280 x 1024) with the push of a Function Key. Video Adjustment An on-screen set-up menu provide access to all video adjustment options. Control Panel The ZS3 has a full –featured control panel/ user interface (see Quick Start Guide below). Multi-Transducer Port The multi-transducer port (MTP) allows up to three transducers simultaneously connect to the system. You can easily activate any of the transducers connected to the cart. Transducer Holders The Safe storage for ZONARE transducers is provided on both sides of the ZS3 System (Figure 2.1). Internal Cart Hard Drive (Cart HD) All current exam images are initially captured and archived to the hard drive. This data can be automatically saved to the internal hard drive (cart HD), transferred using the Export function, or retrieved from the drive using the Import function. The minimum size of the internal hard drive is 120 GB. NOTE: The internal hard drive is not intended for use as a long-term archive. Back up exam and other data on the hard drive regularly.
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CD/DVD Burner The built-in CD/DVD burner allows you to import/ export exams from the system. Note: Before deleting any exam data from the cart hard drive, always verify that data was successfully transferred to the CD/DVD by viewing it on an external reader/ player. When exams are exported onto the CD/DVD, a DICOM viewer program (Showcase®) and its user’s manual are simultaneously exported onto the CD/DVD, allowing the exams to be opened, annotated, and saved in several formats on any commercial PC. Barcode Reader (option) Patient accession numbers or patient ID numbers can be entered via a selection of ZONAREapproved barcode readers that can connect to a system USB port. Foot Pedal (option) A remote 2-pedal footswitch is optionally available for connection to the system via any available USB port. The left pedal activates Freeze and the right pedal activates Store. Backup ZPak Battery (option)
A backup battery may be ordered that can power the system for up to 1 ½ hours of normal use in the absence of a connection to an active AC power outlet, depending on usage. The battery allows the system to be operated in normal use without connection to an active AC Power outlet. The backup is mounted at the base of the system and is automatically kept charged by the DC power suppliers within the system. The battery is charged (as needed) whenever the ZS3 system is connected to active AC power. Printers and Other Peripherals ZONARE offers a number of optional medical-grade (IEC 60601 compliant) peripherals. Detailed instructions, for proper peripheral use, are covered in the manufacturer’s instructions provided at the time of shipment.
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Quick Start Guide
Figure 2.2: Control Panel Powering On/Off 1. Press and release the Power button to turn the system on. The system takes approximately
30 seconds to complete the normal power on sequence. 2. Check the ZS3 display to ensure the ZONARE startup screen is shown. When initialization is
complete, the system is ready for imaging. 3. 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 (Meas Button) 1. Press Meas while image is frozen. 2. Select desired measurement on menu & press Set. 3. Position first caliper with Trackball & press Set. 4. Position second caliper with Trackball & press Set.
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Basic Calculations (Calc Button) 1. Press Calc while image is frozen. 2. Select desired calc on menu & press Set. 3. Position caliper with Trackball & press Set. 4. Position additional caliper(s) with Trackball & press Set. Calc will display on screen. 5. Press Enter or Store to store the result. 6. Press Report to display calcs you’ve recorded.
Export Exams to USB or CD/DVD 1. Press Archive (back row of QWERTY keyboard). 2. Point to Export. This will open Archive Exam Export. 3. Point to Destination. Then click Export at bottom of screen. 4. On next screen, click Options. Archive Exam Export Options screen displays: 5. Select Non-DICOM. Select JPEG or TIFF. 6. Click Apply. 7. Click Export on next screen. Verify export (Yes/No) at prompt. If Yes, exam exports to USB/CD/DVD but is not deleted from hard drive.
Review Images in Current Exam 1. Press Current Exam (back row of QWERTY keyboard). 2. All stored images for exam appear. 3. To view an image in large format, point with cursor and press Set key. 4. Press Current Exam to exit review & return to live imaging.
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Moving the ZS3 system When Moving 1.
Lower the adjustable height to MINIMUM using the height adjustment release lever.
2.
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.
3.
Ensure that the transducer cables are wrapped over the cable hooks.
4.
Place the front wheels in the non-swivel position.
5.
Ensure that all wheels are unlocked, and push the cart from the front when transferring from location to location.
6.
When moving the cart over obstacles, always pull from the front.
When Scanning 1.
Before scanning a patient, apply the brake by fully depressing the brake pedal on each front wheel.
2.
To disengage brakes, flip up the pedals.
Height adjustment The height of the user interface console can be adjusted by squeezing the release lever located inside the right-front handle. Refer to Figure 2.3: Height Adjustment Figure 2.3: Height Adjustment
Release lever
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3. Imaging (Mode Controls) 2D/B-Mode Controls Control
Description/Use
* Indicates this control is also available in retrospective processing. Gain*
Adjust Gain by rotating the outer ring of the B-Mode (2D) button.
Depth
Press the Depth button UP to decrease depth; press DOWN to increase depth.
Harmonics
Press the TH button to toggle on/off tissue harmonic imaging.
Frequency
Press the Frequency button UP to increase transmit frequency; press DOWN to decrease transmit frequency. NOTE: Press Frequency up or down when doing compound imaging to cycle through Frequency and Compounding choices.
Zoom
Acoustic Zoom (live image). The first press displays a Region Of Interest (ROI) that can be positioned/size over the anatomy of interest. The second press zooms the ROI, reconfiguring the scanner to provide enhanced imaging in that region. Display Zoom (Frozen/Cine image) The first press zooms the image. The Depth key changes the magnification. The Trackball pans the image.
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Description/Use
Menu
While B-mode is active the Menu button invokes a pop-up menu showing many secondary optimization controls including:
Optimize*
Maps*
Tint*
Dynamic Range*
L/R invert*
U/D invert*
Persistence*
Edge*
Acoustic Output
Overall/DGC gain: Press the Optimize button to automatically balance the overall/DGC gain. The B-Mode image adjusts the brightness of the image to the default target gain value. Sound speed correction: Press and hold down Optimize to automatically compensate for the sound speed in tissue. The B-Mode image pauses momentarily, then adjusts for the detected sound speed. To exit optimize mode: Double-click Optimize to turn optimize functions off.
B Steer
NOTE: For linear array transducers only Turn B Steer softkey to select B Steer (0°); B Steer 10 (10° right); or B Steer –10 (10° left). NOTE: L8-3 transducer B Steer options: B Steer (0°), B Steer 15 (15° right), B Steer –15 (15° left).
Dual: OFF/ON
Press the Dual mode button to toggle the Dual imaging function on/off. NOTE: The Dual imaging function allows for displaying two separate images on the screen (at the same time) for concurrent comparison/analysis.
Dual: Toggle
Press the Enter button to change the selection of the active/selected image (left or right image, as displayed on screen).
Simul: (Dual)
Press the softkey assigned to Simul to toggle on/off the simultaneous dual imaging update modality. NOTE: When simul dual is active, the two different images, potentially using different modalities (i.e., color Doppler and power Doppler) are dynamically updated, simultaneously. When this function is deselected (standard dual mode) one image is static, while the other image is dynamically active.
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M-Mode Controls M Control
Description/Use
* Indicates this control is also available in retrospective processing. Gain*
Rotate outer ring of the M-Mode button to adjust gain.
Depth
Press the Depth rocker button UP to decrease depth; press DOWN button to increase depth.
Frequency
Press the Frequency button to cycle through the transmit frequency choices. The selected value is displayed in the Image Information area.
Menu
While M-mode is active the Menu button invokes a pop-up menu showing many secondary optimization controls including:
Display Format (full size and split-screen)*
Sweep Speed*
Maps*
Tint*
Dynamic Range*
Persistence*
Acoustic Output
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Color Doppler/Power Doppler Mode Controls CD/PD Control
Description/Use
* Indicates that this control is also available in retrospective processing Gain*
Adjust Gain by rotating the outer ring of the C-Mode button.
Softkeys
While Color Doppler is active the Softkeys at the back of the console shows many optimization controls including:
Steer (Linear transducers only)
Invert*
Filter*
Scale
Baseline*
Power/Velocity Doppler
Frequency
Press the Frequency button to cycle through the transmit frequency choices.
Menu
While Color Doppler is active the Menu button invokes a pop-up menu showing many secondary optimization controls including:
Maps*
Flash Cancelation
Persistence*
Edge*
Acoustic Output
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Strip Doppler Mode Controls (Pulsed Wave and Continuous Wave Doppler) Note: Continuous Wave Doppler imaging is available only on ZS3 systems equipped with the Echocardiology or Advanced Vascular Options. Doppler Control
Description/Use
* Indicates that this control is also available in retrospective processing. Gain*
Adjust Gain by rotating the outer ring of the D-Mode button.
Softkeys
While PW Doppler is active the Softkeys at the back of the console shows many optimization controls including:
Update: o
Update On: Only the B-mode or the Doppler strip is active, not both. Pressing the select key toggles which is active.
o
Update Off: B-mode and Doppler strip are active simultaneously.
Filter*
Invert*
Gate Size
Baseline*
Angle* o
Turning the knob changes the angle correct in 1-degree increments.
o
º)
Pressing the knob snaps the angle correct to (-60-0-60
Volume
Steer (Linear transducers only)
Pressing the knob snaps the steer to preset angles. If CD is active then its
o
Turning the knob changes the steer in 1-degree increments.
steer angle snaps to align. PW/CW: See CW and Echocardiography section Menu
While strip Doppler is active the Menu button invokes a pop-up menu showing many secondary optimization controls including:
Gate Size
Dynamic Range*
Sweep Speed*
Display Format(full size and split-screen)*
Maps*
Tint*
Acoustic Output
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