Zonare Ultrasound User manual
REVISION HISTORY
REV DESCRIPTION DATE
A Initial Release to support Version 4.0 Software/Hardware 1/09
B Updated software release and Scan Module support 4/09
C Updated to 4.1/4.2 software releases 9/09
D Updated Release to Support 4.7 SW & Product Changes 7/11
Q00169 Rev D Page 2 of 304
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
TABLE OF CONTENTS
1 INTRODUCTION.........................................................................................................................................10
1.1 Purpose.................................................................................................................................................11
1.2 Product Overview ................................................................................................................................11
1.3 Product Features.................................................................................................................................12
1.4 Definitions/Acronyms ..........................................................................................................................13
1.5 Documentation Conventions..............................................................................................................15
2 SAFETY .......................................................................................................................................................17
2.1 CAUTIONs and WARNINGs During Service/Operation................................................................17
2.2 Battery WARNINGs.............................................................................................................................18
2.3 CAUTIONs During Service.................................................................................................................18
2.4 Battery CAUTIONs..............................................................................................................................19
2.5 USB Memory Stick CAUTIONs .........................................................................................................19
2.6 Networking CAUTION.........................................................................................................................19
3 SYSTEM SPECIFICATIONS ....................................................................................................................20
3.1 System Dimensions................................................................................................................................20
3.2 Displays.................................................................................................................................................21
3.3 Image Archive or Export Storage......................................................................................................22
3.4 Transducers..........................................................................................................................................22
3.5 Accessories/Options...............................................................................................................................26
3.6 Peripherals............................................................................................................................................26
3.7 Site Requirements...............................................................................................................................26
3.8 System Power......................................................................................................................................27
3.9 System Power Protection...................................................................................................................27
3.10 Electrical Specifications..................................................................................................................27
3.11 Temperature, Humidity, Pressure Limits......................................................................................29
3.12 Device Classification .......................................................................................................................30
3.13 Safety Standards..............................................................................................................................30
3.14 DICOM Standard..............................................................................................................................30
3.15 Product Labeling..............................................................................................................................30
4 TOP-LEVEL PRODUCT OVERVIEW......................................................................................................35
4.1 Major Assembly Identification............................................................................................................35
4.2 Transducers..........................................................................................................................................35
Q00169 Rev D Page 3 of 304
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
4.3 Accessory Components......................................................................................................................36
4.4 SmartCart Major Assemblies (shown with MTP Multi- probe Option).........................................37
4.5 miniCart Major Assemblies ................................................................................................................38
4.6 SmartCart User Interface Controls (Overview)...............................................................................39
4.7 Scan Engine User Interface Controls (Overview)...........................................................................41
4.8 SmartCart User Interface Controls (Detailed) – Version 1............................................................42
4.9 SmartCart User Interface Controls (Detailed) – “Enhanced” Version (2)....................................47
4.10 SmartCart & miniCart Keyboard Controls (Detailed)..................................................................52
4.11 Scan Engine User Interface Controls (Detailed).........................................................................55
4.12 SmartCart Rear I/O Panel: Layout & Functional Definitions ....................................................58
4.13 miniCart I/O Connections: Layout & Functional Definitions .....................................................58
4.14 Scan Engine/Scan Module Rear I/O Ports: Layout & Functional Definitions ........................59
4.15 AVED: Audio-Video Extension Device - I/O Panel: (Option)...................................................59
5 SYSTEM UNCRATING & INSTALLATION PROCEDURES ..............................................................61
5.1 Product Shipment................................................................................................................................61
5.2 Electrical Requirements......................................................................................................................61
5.3 Environmental and Space Requirements........................................................................................61
5.4 Uncrating...............................................................................................................................................61
5.5 Mechanical Verification.......................................................................................................................65
5.6 System Installation:.............................................................................................................................65
5.7 Transporting - Shipping the Scan Engine/Scan Module................................................................74
6 BASIC SYSTEM CONFIGURATION.......................................................................................................75
6.1 Basic System Configuration Procedures .........................................................................................75
7 ARCHIVE MENU FUNCTIONS................................................................................................................83
7.1 “Media” & “Store/Print” Button Configuration...................................................................................83
7.2 “Exam Export” Menu ...........................................................................................................................86
7.3 “Exam Management” Menu................................................................................................................87
7.4 Archive “Export” – OPTION menu.....................................................................................................93
7.5 “Serial Port” Setup - (Export Calc Report Data)..............................................................................95
8 DICOM CONFIGURATION.......................................................................................................................98
8.1 “DICOM” Configuration Overview .....................................................................................................98
8.2 “DICOM” Configuration Parameter Definitions:...............................................................................99
8.3 Z.ONEUltra Pre-Install Survey Form (Sample Only)....................................................................102
Q00169 Rev D Page 4 of 304
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
8.4 “DICOM” Configuration Procedure - Menus..................................................................................106
8.5 “Network” Setup.................................................................................................................................114
8.6 “FTP” Setup........................................................................................................................................116
9 ADVANCED SYSTEM SETUP CONFIGURATION............................................................................118
9.1 “Security” Setup Menus....................................................................................................................118
9.2 “Power Save” Setup Menu...............................................................................................................120
10 GENERAL PROCEDURES................................................................................................................122
10.1 Installing USB Memory Stick, into the Scan Engine/Scan Module.........................................122
11 FUNCTIONAL DESCRIPTIONS.........................................................................................................123
11.1 Overall System...............................................................................................................................123
11.2 SmartCart........................................................................................................................................125
12 POWER & SIGNAL DISTRIBUTION DIAGRAMS..........................................................................129
12.1 SmartCart Power Module Block Diagram (Basic).....................................................................130
12.2 SmartCart Power Module Block Diagram (Detailed)................................................................131
12.3 SmartCart Main Board Cable Connect Diagram (Original DVD Config) ...............................132
12.4 SmartCart Main Board Cable Connect Diagram (IDE/SATA Adapter DVD Config)............133
12.5 SmartCart Main Board Cable Connection Diagram (USB Style DVD Configuration) .........134
12.6 miniCart AC/DC Power Distribution Diagram ............................................................................135
13 FUNCTIONAL BLOCK DIAGRAMS..................................................................................................136
13.1 Z.ONEUltra Overall System Block Diagram (SmartCart w/Cardiac-Option Configuration) 137
13.2 miniCart Configuration: Overall System Block Diagram.............................................................138
13.3 Z.ONEUltra SmartCart - Cardiac Module (CW/ECG) Option - Block Diagram....................139
14 ASSEMBLY DIAGRAMS.....................................................................................................................140
14.1 SmartCart: Power Module Functional Identification .................................................................140
15 PERIPHERALS & ACCESSORIES...................................................................................................141
15.1 DVD/CD Burner - (Internal)"........................................................................................................141
15.2 AVED – Audio Video Extension Device Box - (Option)"..........................................................142
15.3 SONY UP-D897 USB Digital Printer...........................................................................................148
15.4 SONY UP-D25MD Color Printer..................................................................................................154
15.5 HP LaserJet Network (REPORT) Printer ...................................................................................156
15.6 2- Pedal Footswitch.......................................................................................................................160
16 SOFTWARE PROCEDURES..............................................................................................................161
Q00169 Rev D Page 5 of 304
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
16.1 SCAN ENGINE: Standard Software Installation/Upgrade Procedure....................................161
16.2 SCAN ENGINE (Only) “Advanced” Software Installation Procedure.....................................163
16.3 SCAN MODULE: Standard Software Installation/Upgrade Procedure..................................167
16.4 SCAN MODULE: “Clean” Software Install Procedure (“SERVICE” key)..............................169
16.5 SCAN MODULE: “Clean” Software Install Procedure (Undocked or Auto-Load)...............170
16.6 FTP Site Access: Software/File Downloads from Zonare .....................................................172
16.7 “DIAGNOSTIC” Panel Operations...............................................................................................172
17 CLEANING AND DISINFECTING PROCEDURES.........................................................................183
17.1 SmartCart........................................................................................................................................183
17.2 Scan Engine....................................................................................................................................184
17.3 Transducers....................................................................................................................................185
18 MAINTENANCE – CALIBRATION PROCEDURES.......................................................................189
18.1 Foreword .........................................................................................................................................189
18.2 List: Maintenance Procedures......................................................................................................189
18.3 List: Calibration Procedures.........................................................................................................189
18.4 PIC Reset (Power Supply) Procedure.......................................................................................190
18.5 Z-PAK “RECONDITION” Procedure - (SmartCart)...................................................................190
18.6 UI Lift (Gas spring) Release Cable Adjustment - (SmartCart)................................................192
18.7 Touchscreen Calibration - (Scan Engine)..................................................................................193
18.8 Display Monitor Adjustment – User Settings .............................................................................195
19 SYSTEM TROUBLESHOOTING........................................................................................................197
19.1 Foreword .........................................................................................................................................197
19.2 Technical Support Contact Information......................................................................................197
19.3 Troubleshooting..............................................................................................................................199
19.4 System Status LED & Error Code Definitions............................................................................206
19.5 Scan Engine Fan Operation.........................................................................................................214
19.6 SmartCart LCD Display Troubleshooting...................................................................................214
19.7 Battery Performance – Charge Times - Reconditioning ..........................................................215
20 REPAIR PROCEDURES .....................................................................................................................217
20.1 Foreword .........................................................................................................................................217
20.2 Recommended Tools ....................................................................................................................217
20.3 Hardware Service/Replacement Procedures (SmartCart).......................................................217
20.4 Hardware Service/Replacement Procedures (miniCart)..........................................................277
Q00169 Rev D Page 6 of 304
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
20.5 Hardware Service/Replacement Procedures (Scan Engine)..................................................287
20.6 Hardware Service/Replacement Procedures (Transducers)...................................................288
20.7 Service Software Procedures.......................................................................................................291
21 PART NUMBER INFORMATION.......................................................................................................293
21.1 SmartCart........................................................................................................................................293
21.2 miniCart ...........................................................................................................................................296
21.3 Scan Engine....................................................................................................................................298
21.4 Scan Module...................................................................................................................................299
21.5 Transducers....................................................................................................................................300
21.6 Peripherals......................................................................................................................................302
22 INDEX .....................................................................................................................................................303
Q00169 Rev D Page 7 of 304
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
TABLE OF FIGURES
FIGURE 1: LABEL, SCAN ENGINE – SERIAL/PART NO..........................................................................................................31
FIGURE 2: LABEL, SCAN MODULE – SERIAL/PART NO........................................................................................................31
FIGURE 3: LABEL, SCAN ENGINE BATTERY (VERSION 1) - SERIAL/PART NO.....................................................................31
FIGURE 4: LABEL, SCAN ENGINE BATTERY (VERSION 2) - SERIAL/PART NO.....................................................................31
FIGURE 5: LABEL, 100V-240V SMARTCART REAR PANEL - SERIAL/PART NO..................................................................32
FIGURE 6: LABEL, SMARTCART Z-PAK BATTERY ................................................................................................................32
FIGURE 7: LABEL, MINICART REAR PANEL - SERIAL/PART NO.............................................................................................32
FIGURE 8: LABEL, LINEAR ARRAY TRANSDUCERS - SERIAL/PART NO................................................................................33
FIGURE 9: LABEL, CURVED ARRAY TRANSDUCERS - SERIAL/PART NO..............................................................................33
FIGURE 10: LABEL, ENDO CAVITY TRANSDUCER - SERIAL/PART NO.................................................................................33
FIGURE 11: LABEL, PHASED TRANSDUCERS - SERIAL/PART NO........................................................................................33
FIGURE 12: LABEL, SPECIALTY TRANSDUCERS - SERIAL/PART NO....................................................................................33
FIGURE 13: LABEL, AC POWER BATTERY ADAPTER...........................................................................................................34
FIGURE 14: LABEL, AC POWER ADAPTER POWER SUPPLY................................................................................................34
FIGURE 15: Z.ONEULTRA MAJOR ASSEMBLY ILLUSTRATIONS............................................................................................ 35
FIGURE 16: TRANSDUCER ILLUSTRATIONS .......................................................................................................................... 35
FIGURE 17: ACCESSORIES ...................................................................................................................................................36
FIGURE 18: SMARTCART KEYBOARD CONTROLS (OVERVIEW)...........................................................................................39
FIGURE 19: SMARTCART USER INTERFACE (VERSION 1) CONTROLS (OVERVIEW)...........................................................39
FIGURE 20: SMARTCART USER INTERFACE (“ENHANCED” VERSION) CONTROLS (OVERVIEW).........................................40
FIGURE 21: SCAN ENGINE USER INTERFACE CONTROLS (OVERVIEW)............................................................................... 41
FIGURE 22: SMARTCART USER INTERFACE LAYOUT – VERSION 1......................................................................................42
FIGURE 23: SMARTCART USER INTERFACE LAYOUT – “ENHANCED” VERSION (2).............................................................47
FIGURE 24: SMARTCART KEYBOARD LAYOUT......................................................................................................................52
FIGURE 25: MINICART KEYBOARD LAYOUT........................................................................................................................... 52
FIGURE 26: SCAN ENGINE USER INTERFACE LAYOUT (DETAILED).....................................................................................55
FIGURE 27: SMARTCART REAR I/O PANEL..........................................................................................................................58
FIGURE 28: MINICART USB HUB CONNECTIONS.................................................................................................................58
FIGURE 29: SCAN ENGINE/SCAN MODULE REAR I/O CONNECTIONS.................................................................................59
FIGURE 30: AVED OPTION - I/O PANEL (SMARTCART)...................................................................................................... 59
FIGURE 31: MAIN SHIPPING CONTAINER REMOVAL ..............................................................................................................62
FIGURE 32: LOADING RAMP LOWERING................................................................................................................................62
FIGURE 33: REMOVABLE SECTION OF SHIPPING BASE......................................................................................................... 62
FIGURE 34: REMOVING PROTECTIVE STORAGE BAG............................................................................................................ 63
FIGURE 35: BRAKE RELEASE OF WHEELS.............................................................................................................................63
FIGURE 36: BATTERY PACK INSTALLATION..........................................................................................................................66
FIGURE 37: SCANNER DOCKING IN SMARTCART.................................................................................................................66
FIGURE 38: SCAN ENGINE TO MINICART DOCKING..............................................................................................................67
FIGURE 39: AC POWER ADAPTER .......................................................................................................................................70
FIGURE 40: 2-BAY BATTERY CHARGER...............................................................................................................................72
FIGURE 41: INSTALLING USB MEMORY STICK...................................................................................................................122
FIGURE 42: SMARTCART: BRAKE MECHANISM..................................................................................................................127
FIGURE 43: SMARTCART: HEIGHT ADJUSTMENT MECHANISM.......................................................................................... 128
FIGURE 44: SMARTCART: POWER MODULE BLOCK DIAGRAM (BASIC)............................................................................ 130
FIGURE 45: SMARTCART: POWER MODULE BLOCK DIAGRAM (DETAILED) .....................................................................131
FIGURE 46: SMARTCART: MAIN BOARD CABLE CONNECTION DIAGRAMS (ORIGINAL DVD)...........................................132
FIGURE 47: SMARTCART: MAIN BOARD CABLE CONNECTION DIAGRAMS (IDE/USB ADAPTER STYLE DVD)............... 133
FIGURE 48: SMARTCART: MAIN BOARD CABLE CONNECTION DIAGRAMS (USB STYLE DVD DRIVE)............................134
FIGURE 49: MINICART: AC/DC POWER DISTRIBUTION DIAGRAM.....................................................................................135
FIGURE 50: OVERALL SYSTEM BLOCK DIAGRAM (ADVHDWE SCAN ENGINE & SMARTCART W/CARDIAC OPTION) .......137
FIGURE 51: OVERALL SYSTEM BLOCK DIAGRAM (ADVHDWE SCAN ENGINE & MINICART)..............................................138
FIGURE 52: SMARTCART: CARDIAC OPTION (CW/ECG) MODULE BLOCK DIAGRAM.......................................................139
Q00169 Rev D Page 8 of 304
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
FIGURE 53: SMARTCART: POWER MODULE FUNCTIONS DIAGRAM ..................................................................................140
FIGURE 54: AVED: AUDIO VIDEO EXTENSION DEVICE I/O PANEL DIAGRAM...................................................................144
FIGURE 55: MENU SETTINGS (UP-D897)..........................................................................................................................150
FIGURE 56: OPERATOR CONTROLS (UP-D897) ............................................................................................................... 152
FIGURE 57: APPROVED DISINFECTANTS TABLE (IMMERSION-METHOD)...........................................................................185
FIGURE 58: APPROVED DISINFECTANTS TABLE (WIPE-METHOD).................................................................................... 186
FIGURE 59: TRANSDUCER IMMERSION LIMITS....................................................................................................................187
FIGURE 60: MINICART 13” DISPLAY: RECOMMENDED SETTINGS -....................................................................................195
FIGURE 61: SMARTCART 19” DISPLAY: RECOMMENDED SETTINGS................................................................................. 195
FIGURE 62: TRANSDUCER CONNECTOR PIN DAMAGE – (EXAMPLE)................................................................................199
Q00169 Rev D Page 9 of 304
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
1 INTRODUCTION
USA, Canada, Asia
ZONARE Medical Systems, Inc.
420 N. Bernardo
Mountain View, CA 94043
Toll-free line (in USA only) live-voice support: ................................................. 1-877-913-9663
Standard line (USA & International) live-voice support: ................................... 1-650-316-3199
Tech Support fax line ........................................................................................... 1-650-230-2817
Customer Support E-Mail: .......................techsupport@zonare.com or salessupport@zonare.com
Web site..................................................www.zonare.com
FTP site (Service) ..................................ftp://12.40.200.87
Toll-free live-phone support: ............. 1-877-913-9663 (5:00AM – 5:00PM, Pacific Standard Time)
Tech Support FAX line ...................... 1-650-230-2817
Tech Support e-mail........................... techsupport@zonare.com
Corporate web site.............................. www.zonare.com
FTP site (Tech Support Window):
URL............................................ftp://12.40.200.87
Enter the following User Name and Password information:
User Name: (call Tech Support for current login information)
Password: (call Tech Support for current login information)
Q00169 Rev D Page 10 of 304
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
Europe
ZONARE Medical Systems GmbH
Henkestrasse 91
91052 Erlangen, Germany
Tech Support Phone .......................... (+49) 9131-974 94-0 (8:00AM – 5:00PM)
Tech Support e-mail........................... info@zonare.de
Corporate web site.............................. www.zonare.com
1.1 Purpose
This manual’s purpose is to provide information to assist service personnel in performing the service,
maintenance, and repair procedures that may be required to support ZONARE’s Z.ONEUltra
Diagnostic Ultrasound System product.
1.2 Product Overview
ZONARE’s Z.ONEUltra Convertible Ultrasound System provides a combination of a full-featured,
cart-based ultrasound system, with the versatility of a compact, easily transportable to the patient, selfcontained portable unit.
The Z.ONEUltra Convertible Ultrasound System is offered in two different models, utilizing two
different configurations of Carts. The sub-systems that comprise the Z.ONEUltra product are listed
below:
Full-Feature SmartCart or
Portable “Scan Engine” (or docked “Scan Module”
Ultrasound transducer(s)
The portable Scan Engine consists of a limited number of field replaceable units (FRU’s). The FRU’s
for this unit are:
Lithium-Ion battery pack
USB Memory Stick
Scan Engine (complete)
lightweight miniCart
The SmartCart consists of a limited number of field replaceable units (FRU’s). The FRU’s for this
unit are:
Q00169 Rev D Page 11 of 304
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
19” Display Monitor
User Interface Assembly
OLED Sub-Assembly (part of UI)
Main Board Assembly
Power Supply Module
Z-PAK Battery Pack
Scanner Deck (w/MTP)
MTP Bolster Plate (or MTP w/CW)
ECG Module
Misc cables and mechanical assemblies
The miniCart consists of a limited number of field replaceable units (FRU’s). The FRU’s for this unit
are:
AC Fuses
Main Power Supply (DC)
USB Hub
LCD Display
Remote Keyboard
Wheels
In addition to the two different Cart offerings, the Z.ONEUltra Ultrasound System is offered with two
different configurations of scanner electronics.
One version being a standalone portable use “Scan Engine” (with local LCD display and user
interface controls), and the other being a “brains only” (non-portable) “Scan Module”.
Scan Engine Scan Module
The ultrasound transducers are replaced as a single FRU, with no field-serviceable parts.
1.3 Product Features
The Z.ONEUltra ultrasound system includes the following key features:
Q00169 Rev D Page 12 of 304
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
Full function scanning modalities (B-Scan, M-Mode, Color Flow, Power Doppler, PW Dopper)
Remote portability for patient scanning
1.4 Definitions/Acronyms
2D: ................. Two dimensional (B-Mode, Color mode)
BMP: ............. Bit MaP
C: ................... Color Flow Mode (Doppler)
D:................... Doppler (Pulsed Wave) Mode
DICOM:........ Digital Imaging and COmmunication in Medicine
DSP:............... Digital Signal Processing
ESD:............... Electro Static Discharge
EV:................. Endo Vaginal
FPGA: ........... Field Programmable Gate Array
FRU:.............. Field Replaceable Unit
HSSL:............ High Speed Serial Link
LCD:.............. Liquid Crystal Display
LED:.............. Light Emitting Diode
M:................... M-Mode (Motion Mode - Tissue)
NTSC:............
National Television Standards Committee (video standard)
PAL: .............. Phase Alternation by Line (video standard)
PRF:............... Pulse Repetition Frequency
PW:................ Pulsed Wave Mode (Doppler)
Retrospective:.. Post-processing performed on frozen images from memory
SVGA: ........... Super Video Graphics Array
DGC: ............. Depth Gain Compensation
USB:............... Universal Serial Bus
Q00169 Rev D Page 13 of 304
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
VKB:.............. Virtual KeyBoard
Q00169 Rev D Page 14 of 304
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
1.5 Documentation Conventions
This following alert conventions are used in this manual:
1.5.1 Alert Messages
1. A WARNING indicates that PERSONAL INJURY OR DEATH may occur to patient and/or
user if the user does not observe the provided information.
WARNING
2. A CAUTION indicates that DAMAGE TO EQUIPMENT may occur if the user does not
observe the provided information.
CAUTION
3. A PRECAUTION indicates that INCONVENIENCE TO THE USER (such as loss of text
entries or saved settings) may result if the user does not observe the provided information.
PRECAUTION
4. Common terms that have a special meaning for the Z.ONEUltra (e.g. Menu Control or
Trackball) are capitalized to distinguish their special usage (as opposed to a person who does
navigation).
5. Control and function names (e.g. Print Button, Image Display) are capitalized for recognition.
6. Items to be acted upon are underlined (e.g. press the Store Button
). Items needing emphasis
are in boldface type.
1.5.2 Symbols
The following symbol conventions are used in this manual, and/or on the Z.ONEUltra product:
This symbol is used to draw attention to information that may relate to safety of the
patient, the operator, or the equipment.
Q00169 Rev D Page 15 of 304
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
Caution: ESD sensitive
This symbol indicates that the equipment is not Category AP, and therefore must not
be used in the presence of flammable liquids or gasses.
.
Type BF patient applied part (B= body, F= floating applied part).
This symbol indicates that the equipment does not utilize a floating double insulated
isolation connection, and therefore must not be connected to external equipment that
is not protectively earthed (DO NOT connect to class II equipment).
Storage/Operating Temperature conditions
Alternating Current (AC)
Direct Current (DC)
Date of manufacture
Q00169 Rev D Page 16 of 304
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
2 SAFETY
It is extremely important to read the following definitions of WARNING information, prior to
beginning any service on any sub-system within the Z.ONEUltra product. As you see applicability
of each of these noted WARNINGs, during the course of the servicing process, be prepared to
avoid harm to persons and equipment by proper adherence.
2.1 CAUTIONs and WARNINGs During Service/Operation
CAUTION
On the miniCart, to prevent possible damage to the 13” display monitor during system
transport (or moving for relocation within the facility) the monitor should first be folded down
to horizontal, rotated to a center position, and “locked” into place using the provided retaining
pin located on the bottom of the display arm.
CAUTION
To prevent possible damage to the electronics of the system from condensation, the following
warning must be observed:
Anytime that any Zonare equipment (Scan Engine, SmartCart or minCart) is being moved from
an environment that differs greatly in temperature and/or humidity, from the environment
where it has been moved for intended operation, (as a result of shipping or transport) the unit
should be allowed to stand for a period of no less than 30 minutes
powering on.
, prior to inserting battery or
WARNING
WARNING
WARNING
Inspect all cables and power cords BEFORE powering-on the Z.ONEUltra system; or
connecting the transducer. Do not use the system if visual signs of external damage are
observed.
To achieve proper grounding reliability, the Z.ONEUltra SmartCart or miniCart power plug
must be fully inserted into a receptacle marked 'Hospital Grade". Do not remove the
grounding wire. If there is any question of power outlet or power cord integrity, do not
proceed. Obtain qualified technical assistance
.
The ZONARE Z.ONEUltra contains no operator-serviceable components within the enclosures.
To avoid electrical shock, the no covers should be removed except by ZONARE factory trained
personnel. Failure to do so may void the system warranty or service contract coverage
Warnings.
Q00169 Rev D Page 17 of 304
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
WARNING
Do not operate the Z.ONEUltra system in the presence of flammable anesthetics or in a room
recently washed with flammable cleaning and disinfecting agents. Cleaners can produce
explosive vapors. Check labels of original containers of cleaners and disinfectants for warnings
about vapors. Thoroughly ventilate the room, if such vapors may potentially be present, prior
to activating any of the
Z.ONEUltra components.
2.2 Battery WARNINGs
WARNINGS.
The battery has a safe smart device. Do not disassemble or alter the battery in any
way.
Charge the battery at room temperature.
Do not short-circuit battery by directly connecting the positive and negative terminals
with metal objects.
Do not heat or discard battery in a fire.
Do not expose the battery to temperatures above 150 degree F.
Do not charge the battery near a heat source
Do not leave battery in direct sunlight
Recharge battery only using Scan Engine in a docked condition in Z.ONEUltra
SuperCar or miniCartt, or remotely using ZONARE Z.ONE battery charger.
Do not use a damaged battery.
Inspect the battery for damage before charging or placing the battery in the
Z.ONEUltra.
Do not connect battery to an electrical power outlet.
Do not continue to recharge the battery if it does not recharge fully after 4 hours
Battery MUST be REMOVED from Scan Engine, during shipping/transport of the
Z.ONEUltra
2.3 CAUTIONs During Service
CAUTIONS
Apply proper line voltage. Verify that the Z.ONEUltra system is compatible to match
the AC voltage of site receptacle. Also verify that all plugs match the receptacle type.
Mismatched voltage or plug configuration can damage system components.
Protect the system from water or other liquids that could drip into the electronic
components.
Do not drop the transducer(s), or allow them to impact any hard surfaces.
Q00169 Rev D Page 18 of 304
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
Avoid allowing metal contact pins on connector-end of transducers to come in
contact with foreign surfaces (potential for bending pins).
Perform no unauthorized modification to any of the Z.ONEUltra sub-systems.
Unauthorized modification can introduce additional hazards to the product.
2.4 Battery CAUTIONs
CAUTIONS
To protect the battery from potential thermal damage, the system monitors the
temperature of the battery at all times. If the battery is detected as exceeding the
maximum safe operating temperature, a warning message will appear on the display of
the Z.ONEUltra.
To prevent possible damage to the unit, the battery should be REMOVED from the
Scan Engine prior to transport or shipment.
Do not immerse battery in water or allow it to get wet.
Do not put the battery into a microwave oven or pressurized container.
Use only batteries provided by ZONARE
Store the battery between -20 to 60o Celsius (-4 o to 158
o
F).
If the battery leaks, emits orders, emits heat, is deformed or discolored in any way
immediately remove it and stop using it.
2.5 USB Memory Stick CAUTIONs
CAUTIONS
USB Memory Sticks that are purchased from outside sources (besides Zonare) may not be
compatible for use in the Z.ONEUltra. USB Memory Sticks which are labeled as “U3
Smart Technology” on their label or packaging, will NOT be recognized (or function) in
the Z.ONEUltra.
In the case of having one of these incompatible format USB Memory Sticks. There are
freeware U3 Smart Technology “Removal” programs available on the internet, that can
be downloaded and run to make the USB Memory Sticks useable on the Z.ONEUltra
2.6 Networking CAUTION
CAUTIONS
In order to comply with Electro-Magnetic Compliance it is necessary that the
Z.ONEUltra be connected to available Ethernet resources using a high quality, shielded
CAT-5 cable.
Q00169 Rev D Page 19 of 304
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
3 SYSTEM SPECIFICATIONS
This section contains Z.ONEUltra system and accessory specifications. For information on the
specifications for ZONARE authorized peripherals, refer to the manufacturers’ documentation.
3.1 System Dimensions
SmartCart (with Scan Engine installed)
Height:
- Max operational: 157.5 cm (62 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 (28.2 in)
Weight: 57 kg (125lb.)
miniCart (with Scan Engine installed)
Height:
- Max operational: 160 cm (63 in)
- Min operational: 134 cm (53 in)
- Display lowered for transport: 104 cm (41.5 in.)
Width: 57.2 cm (22.5 in)
Depth: 56.1 cm (22.0 in)
Weight: 55 kg (132 lbs.)
Scan Engine
Height: 7.3 cm (2.9 in)
Width: 18.7 cm (7.4 in)
Depth: 25 cm (9.8 in)
Weight: 2.5 kg (5.6 lb) – with battery, no probe
Scan Module
Height: 5.3 cm (2.1 in)
Width: 22.3 cm (8.8 in)
Depth: 25 cm (10.0 in)
Weight: 1.6 kg (3.5 lb)
Q00169 Rev D Page 20 of 304
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
3.2 Displays
SmartCart
19” high resolution color LCD display
1280 x 1024 display format (internal)
1280 x 1024 / 800 x 600 video format - configurable (HDMI output)
0.41 mm pixel pitch
Viewing angle (H/V): 170 degrees typical
Minimum 10:1 contrast
+/- 90o rotation
30o backward tilt
Full 90o forward tilt into secure transport position
Advanced setup parameters via on-screen menu
Integrated system programmed video settings
Multi-Transducer Port (3 Connectors) - Option
miniCart
13” high resolution color LCD display
640x480 display format (internal)
0.41 mm pixel pitch
Viewing angle (H/V): 170 degrees typical
Minimum 10:1 contrast
+/- 90o rotation
30o backward tilt
Full 90o forward tilt into secure transport position
Integrated system programmed video settings
Scan Engine
5.8” high resolution color LCD display
800x480 display format (internal)
640x480 video format (HDMI output port)
0.16 mm pitch
Manual Brightness and Contrast controls
USB 2.0 I/O port (one)
DC power (+12V) input port
Scan Module
640x480 video format (HDMI port)
USB 2.0 port (one)
Q00169 Rev D Page 21 of 304
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
DC power (+12V) input port
3.3 Image Archive or Export Storage
Scan Engine - Internal:
IMPORTANT
The image storage capacity numbers listed below apply ONLY to standalone
(undocked) Scan Engine use, or use when docked in a miniCart. In these applications
resolution of the individual image is 640 x 480.
The image storage capactiy numbers, when a Scan Engine is being used while docked
in a SmartCart, will be approximately 1/3 less. This is due to the higher image
resolution of 800 x 600 that is used in the Z.ONEUltra application.
- 512MB Internal CompactFlash Storage (Standard)
DICOM uncompressed: 1280 images
DICOM RLE: 4060 images
BMP: 1700 images
- 2GB Internal CompactFlash Storage (Option)
DICOM uncompressed: 5000 images
DICOM RLE: 15,900 images
BMP: 6650 images
SmartCart - Internal:
- Internal Hard Drive (120GB version specs referenced below)
DICOM uncompressed: 300,000 images
DICOM RLE: 944,000 images
BMP: 399,0000 images
- Slimline Internal DVD+RW / CD-RW Drive
Cart S/N 3xxx and below:
ATAPI (Parallel) Interface
24X speed writing for CD-R, DVD+R, or DVD+RW discs
Cart S/N 4xxx and above:
USB (Serial) Interface
24X speed writing for CD-R, DVD+R, or DVD+RW discs
3.4 Transducers
C10-3 ........................................................ (I.D. 3)
Penetration Depth 13 CM
Q00169 Rev D Page 22 of 304
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
Number of Elements 64
Field of View 80 degrees
Radius of Curvature 16 mm
Ultrasound Bandwidth 10-3 MHz
C9-4T Convex ...........................................(I.D. 146)
Penetration Depth 14 CM
Number of Elements 128
Field of View 135 degrees
Radius of Curvature 11.5 mm
Ultrasound Bandwidth 9-4 MHz
C9-3 Convex..............................................(I.D. 130)
Penetration Depth 18 CM
Number of Elements 128
Field of View 67 degrees
Radius of Curvature 33 mm
Ultrasound Bandwidth 9-3 MHz
C8-33D 3-D .............................................. (I.D. 140)
Penetration Depth 24 CM
Number of Elements 128
Field of View 79 degrees
Radius of Curvature 40 mm
Ultrasound Bandwidth 8-3 MHz
C6-2 Convex..............................................(I.D. 129)
Penetration Depth 24 CM
Number of Elements 128
Field of View 65 degrees
Radius of Curvature 50 mm
Ultrasound Bandwidth 6-2 MHz
C5-2 Convex
............................................ (I.D. 128)
Penetration Depth 24 CM
Number of Elements 128
Field of View 65 degrees
Radius of Curvature 50 mm
Ultrasound Bandwidth 4-1 MHz
C4-1 Convex
Q00169 Rev D Page 23 of 304
..............................................(I.D. 2)
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
Penetration Depth 30 CM
Number of Elements 64
Field of View 80 degrees
Ultrasound Bandwidth 4-1 MHz
L14-5sp Linear........................................ (I.D. 70)
Penetration Depth 6 CM
Number of Elements 128
Field of View 26 mm
Ultrasound Bandwidth 14-5 MHz
L14-5W Wide Aperture Linear............. (I.D. 66 or 71)
Penetration Depth 10 CM
Number of Elements 192
Field of View 55 mm
Ultrasound Bandwidth 14-5 MHz
L12-4V Veterinary.................................. (I.D. 67)
Penetration Depth 10 CM
Number of Elements 128
Field of View 63 degrees
Ultrasound Bandwidth 12-4 MHz
L10-5 Linear............................................ (I.D. 64)
Penetration Depth 10 CM
Number of Elements 128
Field of View 38 mm
Ultrasound Bandwidth 10-5 MHz
L8-3 Linear
.............................................. (I.D. 65)
Penetration Depth 10 CM
Number of Elements 128
Field of View 38 mm
Ultrasound Bandwidth 8-3 MHz
E9-3 3-D
................................................... (I.D. 141)
Penetration Depth 14 CM
Number of Elements 128
Field of View 135 degrees
Radius of Curvature 10.0 mm
Q00169 Rev D Page 24 of 304
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
Ultrasound Bandwidth 9-3 MHz
EV9-4 Transvaginal................................ (I.D. 144)
Penetration Depth 14 CM
Number of Elements 128
Field of View 135 degrees
Radius of Curvature 12 mm
Ultrasound Bandwidth 9-4 MHz
P10-4 Phased (version 1)........................ (I.D. 7)
Penetration Depth 14 CM
Number of Elements 128
Field of View 80 degrees
Ultrasound Bandwidth 10-4 MHz
P10-4 Phased (version 2)........................ (I.D. 14)
Penetration Depth 12 CM
Number of Elements 128
Field of View 79.6 degrees
Ultrasound Bandwidth 10-4 MHz
P8-3 TEE ...................................................(I.D. 8)
Penetration Depth 18 CM
Number of Elements 64
Ultrasound Bandwidth 7.5-2.7 MHz
P4-1 Phased ............................................ (I.D. 4)
Penetration Depth 30 CM
Number of Elements 128
Field of View 84 degrees
Ultrasound Bandwidth 4-1 MHz
P4-1c Phased
.............................................(I.D. 5 or 6)
Penetration Depth 30 CM
Number of Elements 64
Field of View 84 degrees
Ultrasound Bandwidth 4-1 MHz
A2CW Doppler-Only
(CW Option Required) – I.D. 514)
Q00169 Rev D Page 25 of 304
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
Number of Elements 2
Ultrasound Frequency 2.0 MHz
Ultrasound Bandwidth n/a
A5CW Doppler-Only (CW Option Required) – I.D. 513)
Number of Elements 2
Ultrasound Frequency 5.0 MHz
Ultrasound Bandwidth n/a
3.5 Accessories/Options
2-Pedal Footswitch (Freeze/Store)
2-Bay Battery Charger
AC Power Adapter
USB Memory Stick
AVED (Audio Video Extension Device) Box
o NTSC output:
Horizontal frequency:...........................15.733 KHz
Vertical frequency:...............................59.94 Hz.
o PAL output:
Horizontal frequency:...........................15.625 KHz
Vertical frequency:...............................50.0 Hz.
3.6 Peripherals
SmartCart:
On-Board (Mounted) – Local Image Printing
Sony UP-D897 USB Digital B/W Printer
Off-Board (Un-mounted)
Sony UP-D25MD Color Printer
HP LaserJet (PostScript-3 style) Network Printer -------------------- (Report printing only)
miniCart:
Sony UP-D897 Digital B/W Printer
3.7 Site Requirements
Power
100 – 120VAC, 50-60Hz or 200 – 240VAC, 50-60Hz (Factory Configurable)
Q00169 Rev D Page 26 of 304
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
Environmental
Cooling consistent with 1024 BTU / hour system output (Scan Engine + SmartCart/miniCart)
o
Ambient air temperature of 0
– 35o Celsius (32 o - 95 o F)
Ambient relative humidity of up to 80%, non-condensing
3.8 System Power
SmartCart
- 90 – 120V @ 6A (max)
- 200 – 240V @3A (max)
- Line Frequency: 50 – 60Hz
- 250 W-h - Nickel Metal Hydride (NiMH) battery pack - (Option)
miniCart
- 100 – 120V @ 6A (max)
- 200 – 240V @3A (max)
- Line Frequency: 50 – 60Hz
3.9 System Power Protection
SmartCart
- Re-settable AC circuit breaker
miniCart
- User-replaceable fuses:
T6.3A/250V ..................................................... (100-120V Systems)
T3.15A/250V ................................................... (200-240V Systems)
3.10 Electrical Specifications
DC Voltages:
SmartCart DC Power Supplies
Voltage Purpose Max Current Rating
+12V
+12V
+7 to +14V
VMain Logic Power 12 A
VScanner Power 8 A
VFan Power
variable
Q00169 Rev D Page 27 of 304
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
+12 to +25V
miniCart DC Power Supplies
Voltage Purpose Max Current Rating
+12V
+12V
+5V
Scanner Power Board DC Supplies
Voltage Purpose Total Current
+1.2V
+1.5V
+2.5V
+3.3V
Vfan
+5.0V
V5.0RTC
+12V
HV1
HV2
HV3
VAux Power (Peripherals)
Scan Engine Power 20 A
LCD Display Source Power 6 A
USB Hub Power
DSP Power 2.3 A
Digital FPGA (Digital Board)
Striker (Analog Board)
FPGA busses
ADC’s +1.8V
ADC’s and AFE’s
DDR SDRAM 0.30 A
CPU, FPGA’s, etc. 2.5 A
Cooling fans 0.25A
Power Supply monitoring
Levels shifters, muxes, eeprom.
Local power for PIC, etc. 25 mA
Pulsers 170 mA
Probe Mux Bias Power Transducer dependent
Transmit Power (Tissue) User variable
Transmit Power (Doppler) User variable
Future use
8 A
11.2 A
7.4 A
10 mA
“Z-Pack” Battery (SmartCart) – (Option)
Battery, 13-cell, 15.6 VDC, 16 A-hours, rechargeable Nickel Metal Hydride battery pack
Weight: 7.7 lbs.
Operating range: (values listed are approximations)
- Active use......................................At least 1 hour (mode/display brightness dependent)
- Storage mode.................................Less then 50% loss - 1 month
Battery (Scan Engine)
Battery, 4-cell, 7.4 VDC, 4.4 amp-hours, rechargeable lithium ion battery pack
Operating range: (values listed are approximations)
Q00169 Rev D Page 28 of 304
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
- Active use......................................30-40 minutes (mode & display brightness
dependent)
- Standby mode................................2.0-3.0 hours
- Storage mode (in Scan Engine).....3 weeks
(Scan Engine) Battery Charger, 2-Bay
Models:
- Z311: Domestic Version...............110 VAC power cord
- Z312 : International Version .......220VAC power cord
Operating Modes:
- CHARGE Mode ...........................1.0 hour (dependent current charge state)
- RECALIBRATE Mode................14 hours (discharge->charge->discharge-fully charge)
Bays:
- Left Bay.........................................Recalibrate or Charge operation
- Right Bay.......................................Charge operation only
AC Power Adapter (Advanced Hardware Scan Engine)
Models:
- Z316 : Domestic Version..............110 VAC power cord
- Z317 : International Version .......220 VAC power cord
Voltage Output
- +9V to +12V..................................+/- 5% over loading
3.11 Temperature, Humidity, Pressure Limits
System: (During Operation):
Temperature 0o to 35o Celsius | (32
o
to 95
o
F)
Relative Humidity 15–80%
Elevation 3,100 to (-116) Meters | 10,200 to (-1,250) Feet
System: (During Shipping/Storage): Battery MUST
Temperature -20 to 60o Celsius | (-4 o to 158
be REMOVED from Scan Engine!
o
F)
Relative Humidity 15–90%
Elevation 5,944 to (-116) Meters | 19,500 to (-1,250) Feet
Q00169 Rev D Page 29 of 304
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
3.12 Device Classification
FDA Class II Device Classification
CE / MDD Class IIa-rule 10 active device intended for diagnosis
3.13 Safety Standards
All ZONARE instruments, cables, and diagnostic ultrasound imaging transducers have been designed
to meet the essential requirements contained in:
93/42/EEC (Medical Device Directive).
In addition, all the above listed equipment meets the following appropriate requirements:
UL 60601-1 (Standard for Medical Electrical Equipment Part 1: General Requirements for
Safety)
IEC 60601- (Medical Electrical Equipment Part 1: General Requirements for Safety)
JIS-T-1001 (General Requirements of Medical Electrical Equipment), including limits for
current leakage and isolation from a primary power line
Testing for compliance with the essential requirements of the Medical Device Directive has
been performed.
The Z.ONEUltra meets 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”.
3.14 DICOM Standard
NEMA PS 3.15: 2000, Digital Imaging and Communications in Medicine (DICOM)-Part 15:
Security Profiles
3.15 Product Labeling
The following figures depict the labeling that is required by various regulatory authorities, and
describe their location.
Contact ZONARE if any of these labels are missing or damaged beyond legibility. The Z.ONEUltra
labels herein are for reference only and are not shown to scale.
Q00169 Rev D Page 30 of 304
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
Loading...