SPECIFICATION SHEET. Zone Sonography TM Technology Zone Sonography technology is fundamentally different in two ways:

Transcription

1 z.one PLATFORMS SPECIFICATION SHEET The z.one ultra Convertible Ultrasound System is a state-of-the-art diagnostic ultrasound platform that uses revolutionary Zone Sonography TM technology to deliver fullfeatured premium ultrasound performance in a 5½ pound package. The z.one ultra system provides unprecedented workflow advantages and clinical versatility that is changing where ultrasound is performed, and the way it is practiced. The z.one ultra system s unparalleled software architecture allows for fast convenient upgrades in clinical capabilities, keeping you at the forefront of diagnostic confidence and investment protection. Zone Sonography technology s softwarebased architecture enables the z.one ultra platform to function as the world s first and only Convertible Ultrasound TM system: a fully featured workhorse system with a full user interface and the industry s largest high resolution color LCD that is powered by a removable compact Scan Engine (z.one). This allows the z.one ultra system to instantly convert from a cart-based (z.one ultra) system to a premium compact configuration with no compromise in performance or functionality. The Scan Engine can also be used to power all three ZONARE ultrasound platforms - z.one ultra (SmartCart), z.one system (SuperCart) and z.one mini (minicart). Zone Sonography TM Technology Zone Sonography technology is fundamentally different in two ways: 1. Echo data is acquired in large areas within the field of view, instead of forming the image by conventional line-by-line methods. 2. Channel Domain TM Processing performs beamforming with software instead of with custom hardware. K90030 Rev. B - z.one platforms Specification Sheet page 1 of 13

2 These differences result in faster data acquisition, premium performance in a compact package, and the ability to apply computer processing power advances directly to advancing imaging performance. The comprehensive Channel Domain Data utilized by Zone Sonography technology allows for the Retrospective Optimization of many imaging parameters, e.g. DGC and Gain, on either frozen or Cine Loop images Architecture Channels: Channel Domain Processor (infinite) Frame Rate: > 400 fps (maximum) Dynamic Range (useable) >150dB Convertible Ultrasound TM Solution The z.one ultra system can instantly convert between two configurations - even during an ultrasound study while maintaining all imaging performance. z.one ultra: a fully featured, yet small and nimble, console with full user interface Scan Engine: premium compact performance in a 5½ pound package that provides exceptional portability anytime, anywhere. Applications Abdominal Abdominal Vascular (Renal Stenosis, Aorta, Hepatic, Celiac, SMA Studies) Breast Emergency Medicine (FAST Exam, Central Lines, Peripheral Venous Access) Gynecologic (including Endovaginal) Interventional (Guided Needle Procedures) Obstetrics (all Trimesters) Neonatal/Pediatric Head, Abdomen, Hips Thyroid Vascular (Peripheral, Deep) Superficial Parts Intraoperative (vascular/superficial) Testicular/Scrotum Transcranial Imaging with Doppler Site Requirements VAC, 50-60Hz or VAC, 50-60Hz Cooling consistent with 625 BTU / hour system heat output (Scan Engine + Z.one ultra, no peripherals) Ambient air temperature of 0 35 o Celsius Ambient relative humidity of up to 80%, non-condensing Dimensions z.one ultra (SmartCart) Height: - Max operational: 160 cm (63 in) - Min operational: 128 cm (50.5 in) - Display lowered for transport: 104 cm (41 in) Width: 51 cm (20.1 in) Depth: 72 cm (28.2in) Weight: 57 kg (125 lb) z.one system Height: - Max operational: 143 cm (56.25 in) - Min operational: 128 cm (50.5 in) - Display lowered for transport: 106 cm (41.75 in) Width: 61 cm (24.2 in) Depth: 85 cm (33.6 in) Weight: 85 kg (187 lb) z.one mini Height: - Max operational: 155 cm (61 in) - Min operational: 130 cm (51 in) - Display lowered for transport: 104 cm (41 in) Width: 46 cm (18 in) Depth: 51 cm (20 in) Weight: 50 kg (110 lb) z.one (Scan Engine) Height: 7.3 cm (2.9 in) Width: 25 cm (9.8 in) including handle Depth: 25 cm (9.8 in) Weight: 2.49 kg (5½ lbs) with battery, no transducer K90030 Rev. B - z.one platforms Specification Sheet page 2 of 13

3 System Design z.one ultra (SmartCart) Small footprint and light-weight system design for effortless maneuverability and maximum versatility in tight or crowded spaces Nitrogen gas shock for vertical height adjustment up to 32 cm (12.5 in) of the user interface console for ergonomic customization 13 cm (5 in) diameter wheels with dual shock resistant front and back wheels Front and back wheels are switchable brake, direction lock, and full swivel. 80 GB hard drive for enhanced image storage capabilities Optional battery pack- powers z.one ultra for up to two hours One-finger release of Scan Engine located ideally below user interface for ultimate convertibility Monitor mounted Hi-fidelity stereo speakers Transducer storage - up to 5 transducers Convenient cable management Gel holders Integrated microphone Power cord wrap features Integrated front handles for transport and position z.one system Compact, light, and highly maneuverable for portable exams 15 cm (6 in) of vertical height adjustment of the user interface console for ergonomic customization Front and rear handles for transport and positioning 13 cm (5 in) diameter wheels with front wheel swivel Integrated front mounted brake Integrated footrest Transducer storage Convenient cable management Gel holder Integrated microphone Integrated Hi fidelity stereo speakers Power cord wrap features z.one mini Smallest footprint and most economical cart design; ideal for sites where space and economics are an issue 25 cm (10 in) of vertical height adjustment of the user interface console for ergonomic customization Rear handle for transport and positioning 13 cm (5 in) diameter wheels with front and back wheel swivel Transducer storage Convenient cable management Gel holder Power cord wrap features Scan Engine Removable battery with charge level indicator Rugged, cleanable surfaces Integrated handle / hand support Integrated touch screen and stylus Integrated stereo speakers Integrated microphone Display z.one ultra (SmartCart) 19 (48 cm) high resolution color LCD mounted on articulating arm 1280 x 1024 pixel resolution mm pixel pitch Viewing angle (H/V): 178 degrees typical Minimum 400:1 contrast Well backlit (280 cd / m 2 ) and low glare for bright environments Dynamic feedback sensor for controlling backlight stability and enabling fast warmup Height adjustment via console adjustment as well as articulating arm +/- 180 o rotation 30 o backward tilt Full 90 o forward tilt into secure transport position Integrated Brightness and Contrast controls with on-screen feedback Advanced setup parameters via on-screen menu K90030 Rev. B - z.one platforms Specification Sheet page 3 of 13

4 z.one system 13 high resolution color LCD display 640x480 display format 0.41 mm pixel pitch Viewing angle (H/V): 170 degrees typical Minimum 10:1 contrast Well backlit (400 cd / m 2 ) and low glare for bright environments I-Guard TM dynamic feedback sensor for controlling backlight stability and enabling fast warm-up Temporal enhancement algorithm for improving visualization of moving structures Height adjustment via console adjustment +/- 90 o rotation 30 o backward tilt Full 90 o forward tilt into secure transport position Integrated Brightness and Contrast controls with on-screen feedback Advanced setup parameters via on-screen menu z.one mini 13 high resolution color LCD display 640x480 display format 0.41 mm pixel pitch Viewing angle (H/V): 170 degrees typical Minimum 10:1 contrast Well backlit (400 cd / m 2 ) and low glare for bright environments Height adjustment via console adjustment +/- 90 o rotation 30 o backward tilt Full 90 o forward tilt into secure transport position Scan Engine 5.8 high resolution color LCD display 800x480 display format 0.16 mm pitch Folds down into closed position for transport Brightness and Contrast controls User Interface z.one ultra (SmartCart) Streamlined keyboard layout for best user ergonomics Home base design for easy access to major modes Full size, backlit QWERTY keyboard with non-english accents and characters Organic LED display customized controls for selected imaging modes provides for a less cluttered keyboard Context-sensitive backlit keys (8) DGC slide potentiometers with 45 mm travel (4) User-programmable function keys Context-sensitive onscreen menu 35mm trackball diameter z.one system Context-sensitive backlit keys Full size backlit QWERTY keyboard with non-english accents and characters (8) DGC slide potentiometers with 45 mm travel (4) User-programmable function keys Context-sensitive onscreen menu 50mm trackball diameter z.one mini Uses combination of Scan Engine controls and FastKeys Touch screen Full size backlit QWERTY keyboard with non-english accents and characters Context-sensitive backlit keys Backlit keys 1 inch diameter trackball on Scan Engine (2) User-programmable function keys Scan Engine Common layout and onscreen menus with z.one ultra Designed for operation while set and partially hand-supported (one-thumb operation) Backlit keys 1 inch diameter trackball (2) User-programmable function keys Context-sensitive onscreen menu Touch screen for data entry K90030 Rev. B - z.one platforms Specification Sheet page 4 of 13

5 Transducers New transducer technology, wide bandwidth imaging, and multiple frequency imaging with an expanded range of frequencies including Compound Harmonics. These features provide: Increased sensitivity and resolution More clinical information and expanded applications The transducers are lightweight and ergonomically designed to offer easier imaging access, increased operator comfort, and greater overall clinical impact across all patient types. C5-2 Curved Array Primary Applications: Abdominal, Abdominal Vascular, Obstetrics, Fetal Heart, Gynecologic, Needle Guided Procedures Secondary Applications: Technically Difficult Peripheral Vascular Bandwidth: 5-2MHz Number of Elements: 128 Physical footprint: 20 x 64mm Convex Radius: 50mm Field of View: 65 degrees Biopsy Guide: Option Depth: 24cm 8 Frequencies: - 2D and M-Mode: 4.5 MHz; 3.0 MHz - Tissue Harmonic: 5.0 MHz; 4.0 MHz; 3.0 MHz - Compound Harmonic: 4.0 MHz - Color / Power Doppler: 3.0 MHz - PW Doppler: 2.0 MHz L14-5sp (Special Procedures) Linear Array Primary Applications: Intraoperative (endarterectomy scanning), saphenous vein mapping, Needle Guided Procedures Secondary Applications: Small Parts Bandwidth: 14-5MHz Number of Elements: 128 Physical footprint: 12.6mm X 36.6mm Field of View: 26mm Biopsy Guide: Option Depth: 6cm 10 Frequencies: - 2D and M-Mode: 10 MHz; 7.5 MHz; 5.5 MHz - Tissue Harmonic: 12 MHz; - Compound Harmonic: 12 MHz - Compound: 10 MHz - Color / Power Doppler: 9.0 MHz; 8.0 MHz; - PW Doppler: 8.3 MHz; 5.5 MHz L10-5 Linear Array Primary Applications: Thyroid, Breast, Scrotum, Pediatric Hips, Superficial Parts, Needle Guided Procedures Secondary Applications: Peripheral Vascular Bandwidth: 10-5MHz Number of Elements: 128 Physical footprint: 11 x 43mm Field of View: 38mm Biopsy Guide: Option Depth: 10cm 6 Frequencies: - 2D and M-Mode: 8.5 MHz; 6.0 MHz - Tissue Harmonic: 8.0 MHz - Compound Harmonic: 8.0 MHz - Color / Power Doppler: 5.5 MHz - PW Doppler: 4.6 MHz L8-3 Linear Array Primary Application: Peripheral Vascular Secondary Applications: Pediatric Hips, Technically Difficult Small Parts Bandwidth: 8-3MHz Number of Elements: 128 Physical footprint: 12x43mm Field of View: 38mm Biopsy Guide: Option Depth: 10cm 10 Frequencies: - 2D and M-Mode: 7.0 MHz; 5.5 MHz; 4.0 MHz - Tissue Harmonic: 7.5 MHz; 6.0 MHz - Compound Harmonic: 7.0 MHz - Color Doppler: 5.5 MHz; 4.0 MHz - PW Doppler: 4.6 MHz; 3.5 MHz P10-4 Phased Array Primary Applications: Neonatal/Pediatric Head and Abdomen K90030 Rev. B - z.one platforms Specification Sheet page 5 of 13

6 Secondary Applications: Vascular (Small Footprint Access), Intraoperative Bandwidth: 10-4MHz Number of Elements: 128 Physical footprint: 11x18mm Virtual Array: Wider Field of View Depth: 14cm 9 Frequencies: - 2D and M-Mode: 8.5 MHz; 6.0 MHz; 4.0 MHz - Tissue Harmonic: 8.0 MHz - Compound Harmonic: 8.0 MHz - Color / Power Doppler: 6.25 MHz; 5.0 MHz - PW Doppler: 5.0 MHz; 4.0 MHz P4-1 Phased Array Primary Applications: Small Footprint Access, Trauma (FAST Exams), Deep Abdominal, Abdominal Vascular, Technically Difficult, Renal, Aorta, Needle Guided Procedures Secondary Applications: Technically Difficult: Obstetrics, Fetal Heart, Gyn, Bandwidth: 4-1MHz Number of Elements:128 Physical footprint: 16x31mm Virtual Array: Wider Field of View Biopsy Guide: Option Depth: 30cm 10 Frequencies - 2D and M-Mode: 4.5 MHz; 3.0 MHz; 2.0 MHz - Tissue Harmonic: 4.0 MHz; 3.0 MHz - Compound Harmonic: 4.0 MHz - Color / Power Doppler: 2.9 MHz; 2.5 MHz - PW Doppler: 2.5 MHz; 2.0 MHz P4-1c Phased Array Primary Applications: Transcranial Imaging/Doppler, Small Footprint Access, Trauma (FAST Exams), Deep Abdominal, Abdominal Vascular, Technically Difficult, Renal, Aorta Secondary Applications: Technically Difficult: Obstetrics, Fetal Heart, Gyn Bandwidth: 4-1MHz Number of Elements:128 Physical footprint: 16x31mm Virtual Array: Wider Field of View Biopsy Guide: Option Depth: 30cm 13 Frequencies - 2D and M-Mode: 4.0 MHz; 3.0 MHz; 2.5 MHz; 2.0 MHz - Tissue Harmonic: 4.0 MHz; 3.0 MHz - Compound Harmonics 4.0 MHz - Compound: 3.0 MHz - Color / Power Doppler: 1.8 MHz; 2.0 MHz; 2.7 MHz - PW Doppler: 2.0 MHz; 1.8 MHz E9-4 Endovaginal Primary Applications: First Trimester Obstetrics, Gyn (uterus, ovaries), Needle Guided Procedures Bandwidth: 9-4MHz Number of Elements: 128 Physical footprint: 20 x 26mm Convex Radius: 11.5mm Field of View: 135 degrees Biopsy Guide: Option (disposable and reuseable) Depth: 14cm 6 Frequencies: - 2D and M-Mode: 8.0 MHz; 5.0 MHz - Tissue Harmonic: 7.5 MHz - Compound Harmonic: 8.0 MHz - Color Doppler: 4.5 MHz - PW Doppler: 4.5 MHz Imaging Modes 2D / B-Mode Live Imaging Controls Auto-Opt with ZST Adjust Gain/DGC and Sound Speed Correction Depth up to 30cm (see transducers) Frequency change Tissue Harmonic Imaging Acoustic Zoom PW Doppler Cursor Acoustic Output Live & Retrospective Imaging Controls Auto-Opt with ZST Gain/DGC 2D Gain/DGC K90030 Rev. B - z.one platforms Specification Sheet page 6 of 13

7 Display Zoom (pan/zoom on frozen image up to 4X mag) Grayscale Map Dynamic Range Persistence Edge Enhancement/Smoothing Up/Down Invert Left/Right Invert M-Mode Live Imaging Controls Depth Frequency Tissue Harmonic Imaging Cursor Position Acoustic Zoom Display Zoom (Zoom on Frozen Image) Acoustic Output Live & Retrospective Imaging Controls M Gain/DGC Sweep Speed Display Format (Two B reference image sizes and full screen strip) M Map M Dynamic Range Persistence Edge Enhancement/Smoothing Up/Down Invert Left/Right Invert Color and Power Doppler Live Imaging Controls ROI Position/Size ROI Size up to full screen Velocity Scale Wall Filter Flash Suppression PW Doppler Cursor Steering Angle (linear transducers only) Acoustic Zoom Acoustic Output Live & Retrospective Imaging Controls Color Gain Display Zoom (Zoom on Frozen Image) Color Map Edge Enhancement/Smoothing Baseline Shift Invert Persistence Pulsed Wave Doppler Live Imaging Controls Triplex Mode (simultaneous live 2D, Color, PW Doppler strip) Update (quick switch between live 2D or Color and live PW Doppler strip) Cursor Position Gate Size 1-15 mm Steering Angle Velocity Scale Acoustic Power Live & Retrospective Imaging Controls PW Gain Angle Correct manual 0 to +/-76 degrees Angle Correct Quick 60 Baseline Shift Wall Filter Invert Display Format (1/2; 1/3; full screen strip) Sweep Speed (5 sweep speeds) PW Map PW Dynamic Range Audio Volume Dual Screen Available for all transducers Displays two images side-by-side Ability to display two frozen, one active/one frozen, or two active images Allows Left/Right switching of the active side of the display, while automatically freezing the other side Archiving while in dual image will store both images All measurements and calculations can be performed across combined dual images Simultaneous Dual Imaging Available for all transducers Displays two images (same or different modes), side-by-side in real-time Allows Left/Right switching of the active side of the display: Active side allows optimization, mode changes, while both sides are live simultaneously K90030 Rev. B - z.one platforms Specification Sheet page 7 of 13

8 Retrospective processing adjustments affect both images at the same time Real-time dual image adjustments Dual image archiving will store both images in single frame or loop format Four different Dual image display states (A, B, A:b, a:b) Available on Scan Engine display Imaging Mode Combinations B+CD/PD B+M B+PW (real-time duplex) B+CD/PD+PW (real-time Triplex) Acoustic zoom in all imaging modes Imaging Formats Convex Linear Micro-convex Virtual Array Auto-Opt with ZST Option Available on all transducers Instantly equalizes tissue gain during live or frozen/cine images Automatically corrects for differences in sound speed propagation in a patient s body habitus Auto-Dop Trace feature see Measurements & Analysis Display Zoom Available for all transducers From 1.25X to 4X magnification on frozen image, with panning capabilities Precise measurement of small structures made easier Image Display On-screen display of imaging parameter values Frame rate display during live imaging On-screen display of acoustic output level and Mechanical Index (MI) and Thermal Index (TI) values per NEMA guidelines Patient demographics summary Date & Time Network and disk activity indicators Transducer orientation graphic Depth marker graphics Optional DGC display User interface prompts On-screen biopsy graphics Screen Display z. one ultra (SmartCart) Analog Clock/Drive Capacity Current Exam: Images/Clips/Queue Recent Measurements: Last 3 displayed on screen Patient Schedule: (works from modality worklist) Department Schedule: (works from modality worklist) Reference image is ¼ size of original image Cine Memory Capacity: - Typically greater than 180 frames of B-mode data - 30 seconds of strip data Cine Scroll via trackball control Dynamic Playback, including duplex & triplex Manual Trim of Cine Loops Last half quick trim All retrospective imaging parameters available in cine Cine Loop Storage Ability to store Cine Loops to internal hard drive IQ Scan Raw Image Data Capture Customized image review (Retrospective Processing on 2D, Color, and Spectral Doppler) Research and post-process image analysis Stills, cine loops, and strip modes Exam Management & Presets Multiple Exam Types supported: - Abdominal - Obstetrics - Gynecology - Vascular - Small Parts K90030 Rev. B - z.one platforms Specification Sheet page 8 of 13

9 - Pediatric Exam Type selection automatically customizes: - Patient demographics data forms - Calculations - Annotations & Body Patterns - Imaging Presets Factory Imaging Presets for all exam types Unlimited user-programmable Imaging Presets System Configuration Setup Presets Backup and restore capabilities for all system and imaging presets Patient demographic information can be populated via manual typing, replicating an archived exam, or DICOM worklist (option) International character and accent support via QWERTY keyboard Password controlled access to patient information and/or system imaging to aid in HIPPA compliance Quick close functionality for designating a complete DICOM study and to aid in HIPPA compliance Restart exam capability Image Management Storage capacity: Internal Hard Drive standard 512MB Optional 2GB Memory Internal Drive 80 GB (z.one ultra SmartCart) - DICOM uncompressed: 1280 images - DICOM RLE: 4060 images Storage capacity (2GB option): - DICOM uncompressed: 5000 images - DICOM RLE: 15,900 images Three configurable hard keys, for assigning image transfer to combinations of printers, network devices, and internal storage (two for z.one system) Full size archived image review or 2x2 and 2x3 Thumbnail review Interactive exam selection table to aid in quickly selecting archived exam Configurable formats: - DICOM uncompressed - DICOM RLE Measurements and Annotations on archived images Removable USB Memory Stick media for transfer to a PC Connectivity z.one ultra (SmartCart) Inputs & Outputs DVI (HDMI Connector) (4) USB Ethernet (10/100 Base T) z.one system Inputs & Outputs S-Video (NTSC or PAL): In & Out Composite Video (NTSC or PAL): In & Out Stereo Audio: In & Out Video Printer Expose Ethernet (10/100 BaseT) USB Host Parallel port (future functionality) (2) RS-232 / Serial VCR playback z.one mini Inputs & Outputs USB Hub (2 ports) DICOM Option Verify Service Class Print Service Class Store Service Class Basic Modality Worklist Query In Progress Queue for mobile exams with autosend feature upon network connection Exam push to DICOM from onboard archive Variable compression settings Configuration Setup DICOM Removable Media USB Memory Stick Storage capacity (80 GB option) DICOM uncompressed 200,000 images Optional Peripherals z.one ultra (SmartCart) Sony UP-895/7MD B/W thermal printer, mounted Olympus P11 Color printer, mounted K90030 Rev. B - z.one platforms Specification Sheet page 9 of 13

10 z.one system Sony UP-895/7MD B/W thermal printer, mounted Sony UP-21MD color thermal printer, mounted Panasonic LQ-MD800 DVD Recorder, mounted z.one mini Sony UP-D897 B/W thermal printer, mounted Measurements & Analysis Auto-Dop Trace Automatic Doppler Measurements Automatic tracing of spectral Doppler waveform Derived from heart cycle or time Independent of PW gain Integrates data into Calc Package Requires Auto-Opt with ZST Available measurements: RI, PI, Accel, S/D, HR, AT, TAMX, TAMN General Capabilities Interactive worksheets for reviewing and editing in-process results Formatted reports for Obstetrics, Gynecology, and Vascular Multiple measurements can be used to derive final results (average, last, max) Dynamic display of measurement results Reposition Caliper Configurable, customizable Calc menus Export Data feature to third party software Export Serial Data Generic B-Mode Measurements / Calculations (based on cm units) Distance: up to 4 diameters Circumference/Area (Ellipse or Trace) Volume (3 distance) % Stenosis (Area or Diameter) Depth (from transducer face) Generic M-Mode Measurements / Calculations M distance (cm) Heart Rate (bpm -beats per minute) Generic PW Measurements / Calculations (based on cm/sec units) Velocity Velocity Pairs RI (Resistive Index) PI (Pulsatility Index) Acceleration / Slope S/D (Systolic / Diastolic ratio) A:B (Generic velocity ratio) HR (Heart Rate) AT (Acceleration Time) TAMX (Time Average Max) TAMN (Time Average Mean) OB Measurements / Calculations GA (Gestational Age) by: - BPD (Biparietal Diameter) - HC (Head Circumference) - AC (Abdominal Circumference) - FL (Femur Length) - HL (Humerus Length) - OFD (Occipital Frontal Diameter) - TTD (Transverse Trunk Diameter) - GS (Gestational Sac) - CRL (Crown Rump Length) - Other (User programmable) EFW (Estimated Fetal Weight) by AUA or CUA User selectable contributing measurements for CUA / AUA UT (Uterine) S/D ratio Cord S/D ratio Umb A (Umbilical Artery) S/D ratio Plac (Placenta) peak velocity Ut A (Uterine Artery) peak velocity Fetal Aorta peak velocity MCA (Middle Cerebral Artery) peak velocity AFI (Amniotic Fluid Index) HR (Heart Rate): PW and M CI (Cephalic Index) FL/AC ratio HC/AC ratio User assignable authors: Hadlock, Hansmann, Hellman, Jeanty, Nyberg, Osaka, Tokyo Biophysical Profile scoring Anatomical Survey worksheet with 5 user programmable anatomy labels K90030 Rev. B - z.one platforms Specification Sheet page 10 of 13

11 Biometry percentile reporting with range graphics Multiple gestation reporting, up to 5 fetuses User programmable sequence Fetal Echo Measurements / Calculations (E/A = passive filling of the left ventricle: E and atrial kick: A assignment) (S/D = Systolic and Diastolic assignment) Abdominal Measurements / Calculations Diameter and volume measurements for liver, gallbladder, pancreas, spleen, pylorus, appendix, kidney, adrenal gland, urinary bladder, and fluid Abdominal Vessel Doppler Renal Stenosis Liver Vessels, Aorta, IVC Pediatric Hip Measurement alpha and beta angles B-Mode (Fetal Heart) Asc Aorta diameter MPA (Main Pulmonary Artery) diameter Duct Art (Ductus Arteriosis) diameter LA (Left Atrium) distance RA (Right Atrium) distance RV (Right Ventricle) Wall distance (S/D) RVID (Right Ventricle Internal Diameter) (S/D) IVS (Interventricular Septum) distance (S/D) LVID (Left Ventricle Internal Diameter) (S/D) LVPW (Left Ventricle Posterior Wall) distance (S/D) Heart Circ (circumference) Thor Circ (thorax circumference) PW Doppler (Fetal Heart) MV (Mitral Valve) peak velocity (E/A) TV (Tricuspid Valve) peak velocity (E/A) Asc Aorta peak velocity Desc Aorta peak velocity MR (Mitral Regurgitation) peak velocity TR (Tricuspic Regurgitation) peak velocity MPA (Main Pulmonary Artery) peak velocity Duct Art (Ductus Arteriosis) peak velocity IVC (Inferior Vena Cava) peak velocity Duct Ven (Ductus venosis) peak velocity M-Mode (Fetal Heart) RV (Right Ventricle) Wall (S/D) RVID (Right Ventricle Internal Diameter (S/D) IVS (Interventricular Septum) distance (S/D) LVID (Left Ventricle Internal Diameter) (S/D) LVPW (Left Ventricle Posterior Wall) distance (S/D) GYN Measurements / Calculations Uterine Volume Endometrial Thickness Cervical Length Ovary Volume (Right & Left) Up to (10) Right + (10) Left Follicles: reports either volumes calculated from 1, 2, or 3 distances or average distance Ov RI (Ovarian RI, Right & Left) Ov PI (Ovarian PI, Right & Left) Ut RI (Uterine RI) Vascular Measurements / Calculations (R/L = Right and Left assignment) (P/M/D = Proximal, Mid, and Distal assignment) % Stenosis (R/L) Carotid CCA (Common Carotid Artery: P/M/D, R/L, PSV/EDV) Bulb (R/L, PSV/EDV) ICA (Internal Carotid Artery: P/M/D, R/L, PSV/EDV) ECA (External Carotid Artery: R/L, PSV/EDV) Vertebral (R/L, PSV/EDV) ICA/CCA ratio (R/L) Subclavian (R/L, PSV/EDV) User programmable Carotid Sequence Upper/Lower Extremity Arterial Calc Axillary (R/L) Brachial (R/L) K90030 Rev. B - z.one platforms Specification Sheet page 11 of 13

12 Radial (R/L) Subclavian (R/L) Ulnar (R/L) CIA (Common Iliac Artery) (R/L) EIA (External Iliac Artery) (R/L) CFA (Common Femoral Artery) (R/L) SFA (Superficial Femoral Artery) (P/M/D) (R/L) PFA (Profunda Femoris Artery) (R/L) Pop (Popliteal) (R/L) ATA (Anterior Tibial Artery) (R/L) Peroneal (R/L) PTA (Posterial Tibial Artery) (R/L) Dorsalis Pedis (R/L) Lower Extremity Venous Measurements Diameter, Checklists, Report Page Deep IVC (Inferior Vena Cava) CIV (Common Iliac Vein) EIV (External Iliac Vein) CFV (Common Femoral Vein) SFV (Superficial Femoral Vein) (P/M/D) Profunda Vein Popliteal Vein PTV (Posterior Tibial Vein) Peroneal Vein ATV (Anterior Tibial Vein) Superficial SF Junction (Sapheno-Femoral) GSV (Greater Saphenous Vein)Thigh (P/M/D) GSV Knee GSV Calf (P/M/D) SP Junction (Sapheno-Peroneal) LSV (Lesser Saphenous) (P/M/D) Annotation Package Text annotation Annotation on live, frozen, & archived images Selectable Insert and Overwrite modes User-programmable home position Selection, modification, & deletion of individual words Ability to reposition text groups Pre-programmed quick orientation keys: - Right / Left - Prox / Mid / Distal - Long / Trans / Sagittal / Coronal (2) user programmable annotation libraries per application type Body Pattern graphics 24 body pattern graphics Graphics organized by application type Default graphic customizable in user imaging presets Transducer location graphic with adjustable location and orientation Arrow graphic Available on live, frozen & archived images Up to 15 arrow graphics per image User controlled location & orientation Power Factory Configurable Input Voltage: A (max), 1.5A (no peripherals) (max), 0.75A (no peripherals) Line Frequency: 50 60Hz Safety and Regulatory The z.one Ultrasound platforms have been designed, manufactured, and tested to comply with the following internationally recognized standards: FDA Class II Device Classification CE / MDD Class IIa IEC Medical Equipment safety IEC : Electromagnetic compatibility IEC : Programmable medical device IEC : Particular requirements for the safety of ultrasonic medical diagnostic and monitor equipment CISPR 11:1998, Industrial, Scientific and Medical (ISM) Radio-Frequency Equipment: Group 1, Class A K90030 Rev. B - z.one platforms Specification Sheet page 12 of 13

13 NEMA UD2: Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment NEMA UD3: Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices On Diagnostic Ultrasound Equipment IEC 61157: Requirement for the declaration of the acoustic output of medical diagnostic ultrasonic equipment JIS T 1501: 1984 General methods of measuring the performances of ultrasonic Pulse-echo diagnostic equipment ZONARE Medical Systems, Inc. complies with the following internationally recognized standards: ISO 13485:96 93/42/EEC on medical devices Contact Information ZONARE Medical Systems, Inc 420 N. Bernardo Ave Mountain View, CA ZONARE-1 or (650) info@zonare.com K90030 Rev. B - z.one platforms Specification Sheet page 13 of 13