3 SYSTEM SPECIFICATIONS .................................................................................................................... 18
3.1 System Dimensions ................................................................................................................................18
3.7 Site Requirements...............................................................................................................................23
3.8 System Power...................................................................................................................................... 24
3.9 System Power Protection................................................................................................................... 24
5.6 System Installation:............................................................................................................................. 50
5.7 Transporting - Shipping the Scanner................................................................................................58
6 BASIC SYSTEM CONFIGURATION....................................................................................................... 59
6.1 Basic System Configuration Procedures .........................................................................................59
7 ARCHIVE MENU FUNCTIONS................................................................................................................ 66
22 INDEX .....................................................................................................................................................243
Q00180 Rev B Page 6 of 244
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
FIGURE 16:SPCART USER INTERFACE LAYOUT.................................................................................................................35
• 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)
Q00180 Rev B Page 9 of 244
"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 SP
Diagnostic Ultrasound System product.
1.2 Product Overview
ZONARE’s Z.ONEULTRA SP Ultrasound System provides a full-featured, cart-based ultrasound
system, in a very lightweight package.
The sub-systems that comprise the Z.ONEULTRA SP product are listed below:
• Full-Feature SmartCart SP
• Docked “Scanner” (Scan Engine or Scan Module)
• Ultrasound transducer(s)
The SmartCart SP consists of a limited number of field replaceable units (FRU’s). The FRU’s for
this unit are:
• 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)
Q00180 Rev B Page 10 of 244
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
• MTP Bolster Plate (or MTP)
• Misc cables and mechanical assemblies
The Z.ONEULTRA SP 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 SP ultrasound system includes the following key features:
• 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
Q00180 Rev B Page 11 of 244
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
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
VKB:.............. Virtual KeyBoard
Q00180 Rev B Page 12 of 244
"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 SP (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 SP product:
This symbol is used to draw attention to information that may relate to safety of the
patient, the operator, or the equipment.
Q00180 Rev B Page 13 of 244
"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
Direct Current (DC)
Alternating Current (AC)
Date of manufacture
Q00180 Rev B Page 14 of 244
"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 SP 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 WARNINGs During Service/Operation
WARNING
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.
WARNING
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 SP 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 SP 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 SP SmartCart SP 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 SP 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.
Q00180 Rev B Page 15 of 244
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
WARNING
Do not operate the Z.ONEULTRA SP 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 SP 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.ONE
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.ONE
Ultra
.
− 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.ONE
Ultra
s
2.3 CAUTIONs During Service
CAUTIONS
− Apply proper line voltage. Verify that the Z.ONEULTRA SP 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.
Ultra
− 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.
Q00180 Rev B Page 16 of 244
"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 SP 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.ONE
− 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 60
Ultra
.
o
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 SP. 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 SP.
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
SP
2.6 Networking CAUTION
CAUTIONS
In order to comply with Electro-Magnetic Compliance it is necessary that the
Z.ONEULTRA SP be connected to available Ethernet resources using a high quality,
shielded CAT-5 cable.
Q00180 Rev B Page 17 of 244
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
3 SYSTEM SPECIFICATIONS
This section contains Z.ONEULTRA SP system and accessory specifications. For information on
the specifications for ZONARE authorized peripherals, refer to the manufacturers’
documentation.
3.1 System Dimensions
SmartCart SP (with Scan Module 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: 56 kg (122lb.)
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)
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
3.2 Displays
SmartCart SP
• 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
Q00180 Rev B Page 18 of 244
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
• +/- 90
• 30
• Full 90
o
rotation
o
backward tilt
o
forward tilt into secure transport position
• Advanced setup parameters via on-screen menu
• Integrated system programmed video settings
• Multi-Transducer Port (3 Connectors) - Option
Scan Module
• 640x480 video format (HDMI port)
• USB 2.0 port (one)
• DC power (+12V) input port
Scan Engine
• 5.8” high resolution color LCD display
• 800x480 display format (internal)
• 640x480 video format (HDMI output)
• 0.16 mm pitch
• Manual Brightness and Contrast controls
3.3 Image Archive or Export Storage
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 (or always with a Scan
Module) 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
application.
- Left Bay .........................................Recalibrate or Charge operation
- Right Bay....................................... Charge operation only
• AC Power Adapter (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 0
o
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):
• Temperature -20 to 60
o
Celsius | (-4 o to 158
o
F)
• Relative Humidity 15–90%
• Elevation 5,944 to (-116) Meters | 19,500 to (-1,250) Feet
3.12 Device Classification
• FDA Class II Device Classification
• CE / MDD Class IIa-rule 10 active device intended for diagnosis
Q00180 Rev B Page 26 of 244
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"
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 SP 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.
SP
Figure 1: Label, Scan Module – Serial/Part No.
Q00180 Rev B Page 27 of 244
"Note: Copies are uncontrolled documents - For revision verification see the Master Docum e ntation List"