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
Instructions for Use
ZONARE, the ZONARE logo, ZS3 and z.one
are all trademarks of ZONARE Medical Systems Inc. All other
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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:
Indications for Use ................................................................................................................................. 5
Key to Symbols ....................................................................................................................................... 8
2. Getting Started ................................................................................................................................. 11
Overview of Console, System and Features ..................................................................................... 11
Quick Start Guide – Full Featured User Interface ........................................................................... 14
Quick Start Guide – Special Procedures User Interface .................................................................. 16
Menu Items ........................................................................................................................................... 47
ALARA Principle ................................................................................................................................. 64
Applying ALARA ................................................................................................................................ 64
Direct Controls...................................................................................................................................... 65
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Instructions for Use
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.
1. Introduction
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.one
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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with and without the SP UI option) is used for ultrasound
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Instructions for Use
Features
ZS3
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z.one
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SP *
2D/B-Mode
X X X
M-Mode
X X X
Color Doppler
X X X
Power Doppler
X X X
Continuous Wave (CW) *
X X
Physio Controls *
X X
Contrast *
X X
Elastography
X
3D/4D X
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.
System Features/Transducers & Options Matrix
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Instructions for Use
Transducers
ZS3
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SP *
A2CW *X X
A5CW * X X
C4-1 X X
X
C6-2 X X
X
C8-3 3D X
C9-3 X X
X
C9-3sp X
C10-3 X X
X
L14-5w X X
X
L14-5sp
X X X
L10-5 X X
X
L20-5 X L8-3 X X
X
E9-3 3D X
E9-3 X X
X
E9-4 X X
X
P4-1c X X
X
P8-3TEE
X X X
P9-3ic X
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.
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Instructions for Use
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
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
Key to Symbols
The following symbols may be used in this document or elsewhere in product labeling.
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Instructions for Use
Symbol
Description
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
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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Instructions for Use
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2. Getting Started
Speakers
User Interface
Gel Bottle Holder
Multi-Transducer
Port (MTP)
Power button
Control Panel
height adjust
17 inch display
Front Wheels
(swivel lock orientation)
Storage Bins
Cable
management
hooks
2 USB Ports
Instructions for Use
Please read this document carefully before using the z.one
Overview of Console, System and Features
ultrasound system.
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Figure 2.1: z.one
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System Components
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LCD Display
Instructions for Use
The z.one
17-inch LCD Display shows the ultrasound image, plus patient and imaging
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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 z.one
allows you to enlarge the imaging portion of the monitor to use the full (1280 x
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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 z.one
has a full –featured control panel/ user interface (see Quick Start Guide below).
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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 z.one
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(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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Instructions for Use
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 z.one
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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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1. Connect transducer(s) (cable point up).
2. Press On button (above-right of transducer connectors).
3. Press New Patient
4. Enter patient information and select Exam/Pres on this
screen.
5. Press Freeze to begin imaging.
6. Press Transducer to display softkeys. Press softkey for
desired transducer.
7. Press Exam Type, then select softkey for desired
exam/preset.
8. Begin scanning and acquire desired image.
9. Adjust Depth.
10. Press Optimize to provide best image automatically.
11. Press Freeze to stop live scanning.
12. Use Store/Print to capture images/clips.
Quick Start Guide – Full Featured User Interface
Instructions for Use
Figure 2.2: z.one
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 z.one
display to ensure the ZONARE startup screen is shown. When initialization is
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complete, the system is ready for imaging.
3. To Power Off press and release the Power button. NOTE: When servicing the z.one
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.
Basic Calculations (Calc Button)
1. Press Calc while image is frozen.
2. Select desired calc on menu & press Set.
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Control Panel
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system,
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Instructions for Use
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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1. Connect transducer(s) with
cable pointing up
2. Press ON button (aboveright of transducer
connectors)
3. Press New Patient
4. Enter patient information
and select Exam/Preset
on screen
5. Press Freeze to begin
imaging
6. Press Transducer key to
display softkeys. Press
softkey for desired
transducer
7. Press Exam Type, then
select softkey for desired
exam / preset
8. Begin scanning and
acquire desired image.
9. Adjust Depth toggle key
10. Press Optimize button to
provide best image
automatically
11. Press Freeze button to
stop live scanning
12. Use Store or Print
buttons to capture images
or clips
13. Press End Exam to close
study
Quick Start Guide – Special Procedures User Interface
Instructions for Use
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Figure 2.3: z.one
SP Control Panel
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Instructions for Use
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 z.one
display to ensure the ZONARE startup screen is shown. When initialization is
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complete, the system is ready for imaging.
3. To Power Off press and release the Power button. NOTE: When servicing the z.one
system,
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always be sure to turn the circuit breaker to the Off position.
Basic Measurements (Meas Button)
Depth (cm)
1. During live 2D scanning, press Measure.
2. Position caliper with Trackball.
3. Depth will display on screen.
Distance (cm)
1. Press Measure while 2D or M-Mode image is frozen.
2. Select Distance on menu & press Set.
3. Position first caliper with Trackball & press Set.
4. Position second caliper with Trackball & press Set.
5. Distance between calipers will display on screen.
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:
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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).
3. 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.
Instructions for Use
Restart Closed Exam
1. Press New Patient (QWERTY keyboard).
2. Click Restart (bottom of screen).
3. Point cursor to desired exam and press Set key.
4. Click Select Exam (bottom of screen). Next, press Exit on patient form.
5. You can now resume exam & add images to the study.
6. Press End Exam (QWERTY keyboard) to end exam.
Delete Exams from Archive
NOTE: System has limited memory; delete/transfer exams weekly.
1. Press Archive (QWERTY keyboard).
2. Point cursor to desired exam & press Set key.
Click Delete (bottom of screen). Select Yes to confirm. Exam is deleted from hard drive.
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Instructions for Use
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.
Release lever
Moving the z.one
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When Moving
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 2.4: Height Adjustment
Figure 2.4: Height Adjustment
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3. Imaging (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. Hard key not available
on the Special Procedures interface.
Frequency
Press the Frequency button UP to increase transmit frequency; press DOWN to decrease
transmit frequency. On the Special Procedures interface, repeated pressing of the
push button cycles through the frequency options.
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.
2D/B-Mode Controls
Instructions for Use
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Instructions for Use
Control
Description/Use
Menu
While B-mode is active the Menu button invokes a pop-up menu showing many
secondary optimization controls including:
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
n 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. Hard key not
available on the Special Procedures interface.
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). Hard key Toggle not available on the Special
Procedures interface.
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 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. On the Special Procedures
interface, repeated pressing of the push button cycles through the frequency
options.
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
M-Mode Controls
Instructions for Use
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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:
Strip Doppler Mode Controls (Pulsed Wave and Continuous Wave)
Note: Continuous Wave Doppler imaging is available only on z.one
Echocardiology or Advanced Vascular Options.
system equipped with the
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There are two mechanisms to invoke CW:
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Instructions for Use
Physio Control
Description/Use
* Indicates that this control is also available in retrospective processing.
Exit
Exits the ECG control function without changing the traces.
ECG
Enables or disable the ECG trace
Resp
Enables or disables the Respiratory trace. ECG must be active for the Respiratory
trace to be active.
Sweep
Changes the sweep speed of the traces in 2D and Color. This control does not apply
during strip imaging modes.
ECG Size/ Pos
Pressing this knob toggles between controlling the position and size of the ECG
trace. Turning the knob changes the position or size.
Resp Size/ Pos
Pressing this knob toggles between controlling the position and size of the Resp
trace. Turning the knob changes the position or size.
Exit
ECG
Resp
Sweep
ECG
Size/Pos
Resp
Size/Pos
It can be assigned to a Programmable Mode Key in System setup -> Keys. When invoked this
way the programmable mode key acts as a CW hard key and the “D” mode button is dedicated to
PW.
It can have shared access with PW through the “D” mode button. When invoked, the default
Doppler mode is determined by preset. While strip Doppler is active the right-most soft key
toggles between PW and CW. Subsequent invocations of strip Doppler invoke the last used
Doppler mode.
The optimization controls available in CW are generally the same as in PW. See the Strip
Doppler section (above) for details.
Physio Controls
The Echocardiography Option includes a physio module that supports ECG and respiratory
traces. The ECG must be active to enable respiratory. Presets determine if EGG or both traces
are on by default. The physio traces can be enabled/disabled and controlled through the “ECG”
key in the top row of the keyboard. When the ECG function is invoked the following softkeys are
displayed:
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Instructions for Use
NOTE: ZONARE recommends the following ECG patient cables and lead wires from Advantage
Medical Cables (AMC) (www.advantagemed.com):
AMC LW-3700024/3I (International patient lead wire replacements)
AMC LW-3700024/3A (Domestic patient lead wire replacements)
AMC CB-83340 (ECG trunk cable)
AMC CB-33598-00 (Accessory cable for use without lead wires)
Contrast, Elastography & 3D/4D (Options)
Refer to Section 7: Advance Features for details on Contrast and Elastography. Refer to Section
8 for information related to 3D/ 4D Imaging.
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Instructions for Use
Refer to ZONARE’s Transducers Cleaning and Disinfection, Q00066, for directions,
cautions and warnings associated with the care and maintenance of ZONARE
transducers.
Always examine transducers for damage, such as cracks, splitting, holes, or fluid leaks. If
damage is evident, discontinue use of the transducer and contact ZONARE.
Transducer
Applications
Biopsy Guide
A2CW
Cardiac, Adult
Cardiac, Pediatric
Pediatric
No
A5CW
Pediatric
Peripheral Vascular
No
4. Transducers
The following ZONARE transducers may be available for use with the z.one
system.
NOTE(1): The z.one
Ultrasound System is designed for compatibility with the following
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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.
NOTE(2): Once approved in accordance with local government regulation, access to transducers is
further controlled by individual transducer licensing as determined by purchased system
configuration.
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