Bard Ultrasound System User manual

Site~Rite Vision* Ultrasound System
Technical Manual
9770057

2Site~RiteVision* Ultrasound System
Symbol Reference
BF Type Equipment
Attention, see instructions for use
Drip Proof Equipment
Federal (U.S.A.) law restricts this device
to sale by or on the order of a physician.
Medical Electrical Equipment
Classified by CSA with respect to Electric Shock,
Fire, and Mechanical Hazards only in accordance
with UL60601-1 and CAN/CSA C22.2 No. 601.1
IPX1
Rx Only

3
Technical Manual
Table of Contents
Controls and Connections
Front Panel
Back Panel
Probe Attachment
Hardware
Component Overview
Power System
Software
Keyboard Adjustment
Handle Adjustment
Display Adjustment
Display Rotation
Display Tilt
Locking the Casters
General Specifications
Operating and Storage Conditions
A/C Adapter Specifications
System Battery Specifications
EMC Tables
Leakage Current
2.1
2.1.1
2.1.2
2.1.3
2.2
2.2.1
2.2.2
2.3
3.1
3.2
3.3
3.3.1
3.3.2
3.4
4.1
4.1.1
4.1.2
4.1.3
4.2
4.3
Table of Contents
Section Statement and Purpose1
Roll Stand Adjustments3
Technical Specications 4
Repair and Troubleshooting5
System Overview2

4Site~RiteVision* Ultrasound System
Statement of Purpose / System Overview
This Site~Rite Vision* Ultrasound System Technical Manual is intended to provide technical specifications for the Site~Rite Vision* Ultrasound
System. The system is not field serviceable. For service requests, please call BardAccess Systems’ Technical/Clinical Support at [phone].
Refer to Site~Rite Vision* Ultrasound System Hardware & Operating Instructions for Use (IFU) for a list of warnings and precautions.
The Site~Rite Vision* Ultrasound System has user accessible features on the front and back panels, and an ultrasound probe connection on
the side of the unit.
Press and hold the power button on the display for three seconds to turn the system on or off. The power LED indicates that the system is on.
Note: In standby mode the system remains powered and battery life will be depleted. Standby mode allows the system to power up into the
most recent state more quickly than returning from a full shutdown.
Note: Holding the power button down for 8 seconds can be used to power the system down via a “hard” shutdown. Repeatedly powering the
system down in this manner may damage the operating system and should only be used when other appropriate shutdown methods
are unavailable.
Controls and Connections2.1
Front Panel2.1.1
Statement of Purpose1
Warnings and Precautions
System Overview2
Power Button
Power LED
Figure 2.1.1 Front Panel

5
Technical Manual
System Overview
Insert cords for keyboard, printer, and A/C power adapter into designated ports on the ultrasound display as shown in Figure 2.1.2.
Note: The VGA and Ethernet connections are consistent with VGA and Ethernet standards.
Note: The printer power cable is identical on both ends. Both ends are compatible with both the printer and Site~Rite Vision* Ultrasound System.
Note: The AC adapter cable must be inserted with the flat side of the connector toward VESA mount and the rounded side toward the USB ports.
Back Panel2.1.2
Figure 2.1.2 Back Panel
TowardVESA Mount
Ethernet Port
Battery LEDVGA Port
USB Ports
A/C Adapter
Power Port
Printer
Power Port
VESA
Mount
The printer MUST be
connected to the
lowest USB port

6Site~RiteVision* Ultrasound System
System Overview
Probe Attachment2.1.3
To connect the probe to the display:
Step 1. Insert Probe Connector Step 2. Twist to Lock
Lock
Battery
Not in use
In use
Charging
Charging
Powered A/C
Adapter
Detached
Detached
Attached
Attached
System Power
OFF
ON
OFF
ON
Battery LED Status
OFF
ON
BLINK
ON
Table 2.1.2 Battery LED status

7
Technical Manual
System Overview
Hardware2.2
Component Overview2.2.1
Functional DescriptionComponent
Contain parts, mechanical
support, aesthetics
6 USB ports each with 5V
and 0.5 amps available
Plastic Housing/ Handle
(Cycoloy Resin)
USB Module
EMC protection,
Component mounting
Power storage,
charge status
Sheet Metal Housing
Lithium Ion Battery
Power management and distribution,
battery charging and communication, cooling
Cooling
Power Control Module
Fan
Signal Processing and
Ultrasound Probe connection
Processing, display data, provide user
interface, application management
Beamformer Module
Display and
Computing Platform
Location
Exterior
Within sheet metal housing
Within plastic housing
Within sheet metal housing
Within sheet metal housing
Within sheet metal housing
Within sheet metal housing
Within plastic housing
Table 2.2.1 Major Components of the Site~Rite Vision* Ultrasound System
Figure 2.2.1 Component Overview
The Site~Rite Vision* Ultrasound System is composed of several major components as depicted in Figure 2.2.1. See Table 2.2.1 for a functional
description of each component.
Display and
Computing Platform
Power Control
Module
Beamformer
Module Ultrasound
Probe
A/C Adapter
Power Supply
Printer
USB Memory
Device
Keyboard
Sherlock* II /
Sherlock 3CG*
Sensor
Battery
Data /
Power
Data /
Power
Data /
Power
Power
Power
Power Data
Data
Data
Cooling Fan
USB Module
VISION UNIT
Power

8Site~RiteVision* Ultrasound System
System Overview
Power System2.2.2
20V, 3.25 A
Power Supply
Smart Battery
Charge Controller
9.3V 4.0A
Fused Power Supply
12V Power Supply
3.3V Power Supply
Power Connections are shown in blue
Data/Control Connections are shown in black
5V Power Supply
3.3V Power
Supply
(Microcontroller)
AC Adapter
(24V, 6.25AOutput)
AC Power
Microcontroller
Lithium Ion
Battery
Printer
USB Hub
USB Ports
Fan
Beamformer
Ethernet
Connection (cable)
VGA
Connection (cable)
Computing
Platform
Power Control Module
Figure 2.2.2 Power System

9
Technical Manual
System Overview
Table 2.2.2 Functional Description of Power System
A/C Adapter 24 VDC Provides power to the Site~Rite Vision* Ultrasound System and turns the
microcontroller on.
Turns power supply subsystems on and off depending on system inputs and
changes of state.
Controls charge and discharge of the battery and communicates with the battery
and microcontroller. The battery charges when wall A/C is connected.
Power for the computing and display platform for function and internal
battery charging.
Power for the microcontroller
Microcontroller
Smart Battery
Charge Controller
20V Power Supply
3.3V Supply
Power for the printer
Power for the fan and the ultrasound module
Power for each USB port. Power provided only when the system is on.
Data control for USB ports. This is functional only when the system is on.
9.3V Supply
12V Supply
A/C adapter 24VDC Functional Description
5V Supply
USB Hub

10 Site~RiteVision* Ultrasound System
System Overview
Input Current (A)
Input Current (A)
Input Current (A) Output (W)
6.25
.5 per port
1.63 – 0.7 150
4 (fuse limited)
Pin
1, 3
2, 4
Function
Return
Power
Connection
Connection
Voltage Input (VAC)
Main Power
USB
100 - 240
Printer Power
Diagram
Input Voltage (VDC)
Input Voltage (VDC)
Input Frequency (VAC)
24 ± 5%
5 ± 5%
47 - 63
9.3 ± 5%
Power Specifications
Voltage Inputs:
Voltage Outputs:
A/C Adapter Power Supply Specifications:
Fusing:
The Site~Rite Vision* Ultrasound System has several fuses which are not serviceable. These include fusing
for the A/C adapter, the 24V input to the power control module, the 20V supply to the computing and display
platform and the 9.3 volt supply to the printer. For power system failure contact Bard Access Systems’
technical/clinical support at [phone].
2
4
1
3

11
Technical Manual
System Overview
Software:2.3
Site~Rite Vision* Ultrasound System runs on a Microsoft Windows* based operating system. Figure 2.3 depicts the software ap-
plication interactions of the Site~Rite Vision* Ultrasound System. The application toolbar located in the bottom left corner of the
screen acts as the central control point of the Site~Rite Vision* Ultrasound System. It launches and closes applications and offers
configuration options. The operating instructions for each application are described in their respective instructions for use.
Site~RiteVision*
Software
Configuration
Application
Power Control
Application
DICOM Software
Sherlock* II/
Sherlock 3CG*
Software
ApplicationToolbar
Battery Monitor
CalibrationTool
Skin SelectionTool
Date andTime
Properties
AC Power Icon
Figure 2.3 Site~RiteVision* Ultrasound System Application Interactions

12 Site~RiteVision* Ultrasound System
Roll Stand Adjustments
Keyboard Adjustment3.1
Rotation of the keyboard arm can be adjusted by tightening or loosening two fasteners on the bottom side of the keyboard arm with
a ½ inch socket wrench. After the arm has been positioned, the fasteners can be tightened to lock the arm in position.
Note: Tightening the keyboard arm fasteners too much will prevent the user from adjusting the arm during use. Loosening the
keyboard arm fasteners too much may cause the arm to disassemble.
Roll Stand Adjustments3
Keyboard Adjustment
Fasteners
Figure 3.1 Keyboard Adjustment

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Technical Manual
Roll Stand Adjustments
Handle Adjustment3.2
The roll stand handle is designed to fold down for storage and fold up for transport.
The hinge will function after the handle has been lifted up.
To fold handle down:
The handle can be put in the transport position by reversing the steps.
Step 1: Lift up the handle
Step 2: Fold handle down

14 Site~RiteVision* Ultrasound System
Roll Stand Adjustments
Display Adjustment3.3
Display Rotation3.3.1
Display Tilt3.3.2
The roll stand is designed to allow the user to rotate the display 160° in the horizontal plane, 80° to the right and 80° to the left.
To adjust the position of the display in the horizontal plane, turn the display to the desired position.
Note: Extending the rotation of the display more than 80° in either direction could result in the system tipping, causing injury and/or
damage to the system.
The display can be tilted by rotating the display on its vertical pivot. If the tilt is too tight or too loose, this can be adjusted.
Adjusting tilt movement:
• Loosen the display tilt by rotating the clamp lever counter-clockwise.
• Tighten the display tilt by rotating the clamp lever clockwise.
• Reposition the display tilt clamp lever by lifting up and rotating.
Figure 3.3 DisplayTilt Clamp

15
Technical Manual
Roll Stand Adjustments
Locking the Casters3.4
There are three caster locks on the roll stand. Two are dark gray in color; one is light gray in color. The dark gray caster locks fix the
position of the casters, but still allow the casters to roll. The light gray caster lock is a brake and fixes the position of the caster and
prevents the castor and stand from rolling.
Figure 3.4 Caster Locks
Brake
Fixed Position

16 Site~RiteVision* Ultrasound System
Technical Specifications
General Specications
4.1
Operating and Storage Conditions
4.1.1
A/C Adapter Specications
4.1.2
System Battery Specications
4.1.3
Technical Specifications4
Operating Temperature:
Manufacturer:
Battery Chemistry:
Dimensions:
Output Voltage:
Storage Temperature:
Model Number:
System Run Time
on Full Charge:
Weight:
Output Current (Max):
Operating Humidity:
Input Voltage:
Charge Time (Full):
Power Sources:
Monitor Size:
Storage Humidity:
Input Current (Max):
Power Consumption:
IEC 60601-1:
59ºF to 104ºF (10ºC to 40ºC)
XP Power
Lithium Ion
14”W x 12”H x 5”D
24 VDC
0ºF to 104ºF (-18ºC to 40ºC)
AMM150PS24
3.0 Hours
14 lbs
6.25 Amps
5% to 85% Relative Humidity (non-condensing)
100-240 VAC, 50/60 Hz
8.0 Hours
Internal battery, AC adapter
5% to 95% Relative Humidity (non-condensing)
1.6 A at 115 VAC, 0.8 Aat 230 VAC
60-180W
1280 x 800 Widescreen format
Class II, Continuous Operation, Internally Powered Equipment, Not Category
AP orAPG Equipment, Not protected against ingress of water.

17
Technical Manual
Warning: The use of accessories other than those specified in Section 2.3 of the Site~Rite Vision* Ultrasound System Hardware
and Operating System instructions for use may result in increased emissions or decreased immunity of the Site~Rite
Vision* Ultrasound System.
Note: While the Site~Rite Vision* Ultrasound System is not classified to be used in a domestic environment, there may be a need
for the health care professional to use the system for a limited duration.
Warning: This system, with its applicable accessories, is intended for use by healthcare professionals only. If used in a domestic
environment, this system may cause radio interference or may disrupt the operation of nearby equipment. It may be
necessary to take mitigation measures such as re-orienting or relocating the Site~Rite Vision* Ultrasound System or
shielding the location.
Technical Specifications
RF Emissions CISPR 11
RF Emissions CISPR 11
Harmonics IEC 61000-3-2
Flicker IEC 61000-3-3
Group 1
Class A
Class A
Complies
The Site~Rite Vision* Ultrasound System uses RF
energy only for its internal function. Therefore, its RF
emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
The Site~Rite Vision* Ultrasound System is suitable
for use in all establishments, other than domestic,
and those directly connected to the public low-voltage
power supply network that supplies buildings used for
domestic purposes.
Electromagnetic Environment – Guidance
EmissionsTest Compliance
EMC Tables
4.2
The Site~Rite Vision* Ultrasound System is intended for use in the electromagnetic environment specified below.
The customer or user of the Site~Rite Vision* Ultrasound System should ensure that it is used in such an environment.
GUIDANCE AND MANUFACTURER’S DECLARATION - EMISSIONS
Site~RiteVision* Ultrasound System EMCTables

18 Site~RiteVision* Ultrasound System
Technical Specifications
ESD
EN/IEC 61000-4-2
EFT
EN/IEC 61000-4-4
Surge
EN/IEC 61000-4-5
Voltage
Dips/Dropout
EN/IEC 61000-4-11
Power Frequency
50/60 Hz
Magnetic Field
EN/IEC 61000-4-8
±6kV Contact
±8kV Air
±2kV Mains
±1kV Input/Output Lines
±1kV Differential
±2kV Common
>95% Dip for 0.5 Cycle
60% Dip for 5 Cycles
30% Dip for 25 Cycles
>95% Dip for 5 Seconds
3 A/m
±6kV Contact
±8kV Air
±2kV Mains
±1kV Input/Output Lines
±1kV Differential
±2kV Common
>95% Dip for 0.5 Cycle
60% Dip for 5 Cycles
30% Dip for 25 Cycles
>95% Dip for 5 Seconds
3 A/m
Floors should be wood, concrete or
ceramic tile. If floors are synthetic,
the relative humidity should be at
least 30%.
Mains power quality should be that
of a typical commercial or hospital
environment.
Mains power quality should be that
of a typical commercial or hospital
environment.
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the Site~Rite Vision* Ultrasound
System requires continued
operation during power mains
interruptions, it is recommended
that the Site~Rite Vision* Ultrasound
System be powered from an uninter-
ruptible power supply or battery.
Power frequency magnetic fields
should be that of a typical commer-
cial or hospital environment.
ImmunityTest Compliance LevelEN/IEC 60601 Test Level Electromagnetic Environment
Guidance
The Site~Rite Vision* Ultrasound System is intended for use in the electromagnetic environment specified below.
The customer or user of the Site~Rite Vision* Ultrasound System should ensure that it is used in such an environment.
Guidance and Manufacturer’s Declaration – Immunity

19
Technical Manual
Technical Specifications
Conducted RF
EN/IEC 61000-4-6
Radiated RF
EN/IEC 61000-4-3
3 Vrms
3 V/m
Max Output Power
(Watts)
0.01
0.1
1
10
100
Separation (m)
80 to 800 MHz
D = 1.2 ( √P)
.1166
.3689
1.1666
3.6893
11.6666
Separation (m)
800 MHz to 2.5 GHz
D =2.3( √P)
.2333
.7378
2.3333
7.3786
23.3333
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
Portable and mobile communications
equipment should be separated from
the Site~Rite Vision* Ultrasound
System by no less than the distances
calculated/listed below:
D = 1.2 (√P)
D = 1.2 ( √P) 80 to 800 MHz
D = 2.3 ( √P) 800 MHz to 2.5 GHz
where P is the max power in watts
and D is the recommended separa-
tion distance in meters.
Field strengths from fixed transmit-
ters, as determined by an electro-
magnetic site survey, should be less
than the compliance levels.
Interference may occur in the
vicinity of equipment containing a
transmitter.
Separation (m)
150 kHz to 80 MHz
D = 1.2( √P)
.1166
.3689
1.1666
3.6893
11.6666
ImmunityTest Compliance LevelEN/IEC 60601 Test Level Electromagnetic Environment
Guidance
The Site~Rite Vision* Ultrasound System is intended for use in the electromagnetic environment specified below. The
customer or user of the Site~Rite Vision* Ultrasound System should ensure that it is used in such an environment.
The Site~Rite Vision* Ultrasound System is intended for use in the electromagnetic environment in which radiated
disturbances are controlled. The customer or user of the Site~Rite Vision* Ultrasound System can help prevent electro-
magnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment
and the Site~Rite Vision* Ultrasound System as recommended below, according to the maximum output power of the
communications equipment.
Guidance and Manufacturer’s Declaration – Emissions
Recommended Separation Distances between portable and mobile RF Communications
equipment and the Site~RiteVision* Ultrasound System

20 Site~RiteVision* Ultrasound System
Technical Specifications
Leakage Current4.3
Leakage current does not exceed allowable limits according to IEC60601-1:1988, Medical Electrical Equipment, Part 1: General
Requirements for Safety, including Amendment 1 and Amendment 2. Measured leakage currents are provided in the table below.
Type of leakage current and test condition
(including single faults) Supply Voltage Supply Frequency Measured Max Remarks
EN (N.C.) 264Vrms 63Hz 18μA (B)
25μA (A)
EN (S.F.C.) 264Vrms 63Hz 29μA (B)
40μA (A)
P (N.C.) 264Vrms 63Hz 5μA (B)
7μA (A) Ultrasound probe
P (S.F.C.) 264Vrms 63Hz 7μA (B)
124μA (A) Ultrasound probe
PM 264Vrms 63Hz 9μA (B)
24μA (A) Ultrasound probe
PA (N.C.) 264Vrms 63Hz 6μA (B)
5μA (A)
PA (S.F.C.) 264Vrms 63Hz 7μA (B)
5μA (A)
EN (Internally powered) 24Vdc N/A 4μA (B)
4μA (A)
P (Internally powered) 24Vdc N/A 3μA (B)
3μA (A) Ultrasound probe
PM (Internally powered) 24Vdc N/A 22μA (B)
18μA (A) Ultrasound probe
PA (Internally powered) 24Vdc N/A 3μA (B)
3μA (A)