Bard Site-Rite 5 User manual

An issued or revision date for these instructions is included for the users information. In the event two years have elapsed between this date and
product use, the user should contact Bard Access Systems, Inc. to see if additional product information is available.
Revision date: May, 2006.
* Bard and Site~Rite are trademarks and/or registered trademarks of C. R. Bard, Inc. or an affiliate.
Copyright © 2006 C. R. Bard, Inc. All Rights Reserved.
Site~Rite*5 Ultrasound System
Manufactured by:
Bard Access Systems, Inc.
Salt Lake City, UT 84116
U.S.A.
[phone]
Customer Service: [phone]
Technical/Clinical Support: [phone]
Fax: [phone]
www.bardaccess.com
0712929 0605R

2 Site~Rite*5 Ultrasound System
Do not operate in the presence
of flammable anesthetics
Do Not Dispose of
Battery Pack In Fire
BF Type Equipment
AC Adapter
Dot Markers Active
Dangerous Voltage
Power/Stand-by
Warning: Refer to
Manual Before Use
Humidity Parameters
Medical Electrical Equipment
Classified by ETL with respect
to Electric Shock, Fire, and
Mechanical Hazards only in
accordance with UL60601-1
and CAN/CSA C22.2 No. 601.1
Class II Equipment

3
Technical Manual
10
o
C
35
o
C
Storage Temperature
Parameters
Fragile
Prescription Only
Battery Pack
Freeze Image
Gain
Depth (In Centimeters)
cm
15
o
C
38
o
C
Operating Temperature
Parameters
Ultrasound Probe
Do not dispose with
ordinary municipal waste

4 Site~Rite*5 Ultrasound System

5
Technical Manual
Table of Contents
1 Warranty
2 Warnings, Precautions and Notes
3 Site~Rite*5 Ultrasound System Description
3.1 Power Source
3.2 Scanner Assembly
3.3 Transducer Assembly
3.4 Front Panel Controls
3.5 Display Screen Information
4 Installing Site~Rite*5 Software
5 Calibrating the Internal Battery
6 Troubleshooting & Error Screens
7 Site~Rite*5 System Specifications
7.1 Operating and Storage Conditions
7.2 Scanner Specifications
7.3 Probe Specifications
7.4 Power Supply Specifications
8 Standards Information
9 Disposal Information
Section

6 Site~Rite*5 Ultrasound System
1Warranty
The manufacturer, Bard Access Systems, warrants this product against defects in material and work-
manship for a period of one year from the date of original purchase, and agrees to repair, or at Bard
Access Systems' discretion, replace any defective unit free of charge. The warranty on the repaired or
replaced unit continues from the purchase date of the original unit. This warranty does not cover dam-
ages resulting from misuse, abuse, modification, or alteration of the Site~Rite* 5 System.
The following actions void the warranty of the Site~Rite* 5 System:
• Opening or servicing the scanner or the probe housing.
• Removal of system labels by anyone other than by Bard Access Systems
authorized service personnel.
• Opening or servicing the battery pack or the combination A/C adapter and battery
charger by anyone other than Bard Access Systems authorized service personnel.
• Connecting the Site~Rite* 5 scanner to any power source other than the Site~Rite* 5
combination A/C adapter and battery pack.
• Connecting the Site~Rite* 5 scanner to any A/C adapter other than the one
provided with the scanner.
• Connecting the Site~Rite* 5 System to any unauthorized accessory.

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Technical Manual
2Warnings, Precautions and Notes
Warnings
Warning: This product should only be operated by qualified medical personnel.
Warning: Do not remove outer protective covers from the Site~Rite* 5 scanner. Hazardous
voltages exist at several points within the system.
Warning: Do not operate the Site~Rite* 5 Ultrasound System or the Site~Rite A/C adapter and
battery charger in the presence of flammable anesthetics or gases. Explosion
may result.
Warning: Do not use for ophthalmic indications. Ophthalmic use may cause patient injury.
Warning: Misuse of the Site~Rite* 5 System may result in damage to the equipment or
personal injury.
Warning: Use only the combination Site~Rite A/C adapter and battery charger to charge
Site~Rite* 5. Use of any other device to charge Site~Rite* 5 battery packs may
damage the battery packs and will void your warranty.
Warning: Only connect a Site~Rite* 5 combination A/C adapter and battery charger to the
Site~Rite* 5 System. Use of any other A/C adapter may cause intermittent
or unpredictable operation, may damage the system and will void your warranty.
Warning: If a probe is damaged in any way, discontinue use immediately. Damage to the
scanner may occur.
Warning: Avoid subjecting the probe to excessive mechanical shock. Damage to the probe may
occur.
Warning: Use only Bard Access Systems probes with this system. Use of unapproved probes
may result in patient injury or equipment damage.
Warning: When using Site~Rite Needle Guides on the Site~Rite probe, use only sterile plastic
probe covers that are 1 mil (0.001 inch or 0.0254 mm) thick.
Warning: Do not allow liquid to enter the scanner, combination A/C adapter and battery
charger, probe connector or probe port. Damage to equipment may occur.

8 Site~Rite*5 Ultrasound System
Warnings (continued)
Warning: Do not attempt to sterilize the Site~Rite* 5 scanner or probes with ethylene oxide or
heat sterilization methods. Damage to the equipment may occur.
Warning: Always properly dispose of dead battery packs in accordance with local regulations.
Improper disposal may present an enviromental hazard.
Warning: Only qualified personnel should attempt to service this equipment. The Site~Rite* 5
contains static sensitive components and circuits. Failure to observe proper static
control procedures may result in damage to the system.
Warning: The following actions void the warranty of the Site~Rite* 5 System.
• Opening or servicing the scanner or the probe housing.
• Removal of system labels by anyone other than by Bard Access Systems
authorized service personnel.
• Opening or servicing the battery pack or the combination A/C adapter and battery
charger by anyone other than Bard Access Systems authorized service personnel.
• Connecting the Site~Rite* 5 scanner to any power source other than the Site~Rite* 5
combination A/C adapter and battery pack.
• Connecting the Site~Rite* 5 scanner to any A/C adapter other than the one
provided with the scanner.
• Connecting the Site~Rite* 5 to any unauthorized accessory.
Warning: Inspect A/C adapter and battery cord for damage. If any of the prongs are damaged,
use battery power until replacement cord is obtained.
Warning: Verify that all accessories attached to the system comply to 60601 safety standards.
Non-compliance may result in increased patient risk.
Warning: Use only IEC or ISO approved safety devices outside the patient environment. Failure
to do so may damage the equipment.
Warning: Equipment that relies on basic insulation only shall not be used with this system.
Failure to comply could result in increased patient risk.
Warning: Maximum shelf load on the VAD bedside roll stand is 22 lbs. Exceeding this weight may
damage the roll stand.

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Technical Manual
Warnings (continued)
Warning: Do not overtighten screws when attaching to the VESA roll stand mount. Doing so
may damage the scanner.
Warning: Use only screws provided in packaging. Ensure the unit is secure against the VESA
roll stand mount. Failure to do so may cause the scanner to disconnect from the VESA
roll stand mount.
Warning: Do not use the probe with high frequency surgical equipment. Doing so may damage the
equipment.
Warning: Do not pull on probe cable. Doing so may cause the system to tip.
Precautions
Caution: The adverse biological effects of ultrasound on tissue appear to be threshold effects.
When tissue is repeatedly exposed to ultrasound, with intervals in between, there will
likely be no cumulative biological effect. If, however, a certain threshold has been passed
biological effects may occur. While the Site~Rite* 5 acoustic output parameters fall well
below all FDA thresholds for adverse biological effects, any given Ultrasound Procedure
should be performed using the principle of ALARA (As Low As Reasonably Achievable).
The licensed medical practitioner should limit the time of patient exposure to ultrasonic
radiation using the principle of ALARA.
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
Caution: Do not pull the cable to disconnect the probe connector from the scanner. Pulling the
cable may damage the cable, cable connection or scanner.
Caution: Do not twist or bend the probe cable in excess of that required during normal use of
the probe. Excessive twisting or bending of the cable may cause failure, intermittent or
unpredictable operation.
Caution: When disinfecting the probe with a liquid disinfectant, do not soak the probe cable,
cable bend relief, probe connector or probe buttons. Doing so may damage the probe.
Caution: Only apply commercially available ultrasonic couplant, which has been specifically for-
mulated for use in medical applications, to the acoustic window (or face) of the probe.

10 Site~Rite*5 Ultrasound System
Precautions (continued)
Caution: Use water or rubbing alcohol and a soft cloth to remove couplant from the acoustic
window (or face) of the probe. Failure to do so may scratch the acoustic window.
Caution: Do not to allow ultrasonic couplant to dry on the acoustic window (or face) of the
probe. If the couplant should dry, use water or rubbing alcohol and a soft cloth to
remove it. Never use a tool of any kind to remove dry couplant from the acoustic
window (or face) of the probe.
Caution: Some commercially available probe covers contain latex. Natural rubber latex may
cause allergic reactions. Refer to the US FDA alert titled: “Medical Alert: Allergic
Reactions to Latex-Containing Medical Devices”, issued March 29, 1991.
Bard Access Systems distributes sterile probe covers and needle guide kits that do
not contain latex.
Caution: Do not force the probe connector. Damage to the connector and system could result.
Caution: Always snap the needle guides on to the probe hook. Do not slide the needle guide
on to the needle guide hook, as the sterile sheath may tear.
Caution: Do not subject the probe to excessive vibration. Vibration may dislodge sensitive
components and cause intermittent or unpredictable operation.
Caution: Prior to each use please inspect the integrity of all power cords and connectors as
well as the integrity of the unit itself. If any problems are found please discontinue
use immediately and contact an authorized service representative. Use of a damaged
power cord could damage the machine.
Caution: Unapproved extension cords should not be used with this system. Doing so may
damage the system.
Caution: During use, the AC connector needs to be easily accessible. In case of emergency
remove the power cord as soon as possible.
Caution: To avoid unnecessary strain on the user, use the device in a comfortable manner.
Caution: Attach power source in such a way as to prevent damage. Improper installation may
damage power cords.
Caution: Inspect the probe prior to each use. If damage to the cable or transducer face is noted,
do not use the probe. Damage to the system may occur.

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Technical Manual
Precautions (continued)
Caution: Hot water (in excess of 113oF or 45oC) may damage the probe.
Caution: Use only Bard Access Systems cleaning and disinfection procedures. Failure to do so
may damage the device.
Notes
Note: When cleaning the system and components, it is important to remove all particles or
other matter from all surfaces and crevices.
Note: For 240 V applications use only center tapped 240 VAC single phase power.

12 Site~Rite*5 Ultrasound System
3Site~Rite* 5 Ultrasound System Description
The Site~Rite* 5 Ultrasound system contains three major components. (See Figure 1)
• Power Source (External AC Adapter or Base Unit Battery System/AC Adapter)
• Scanner Assembly
• Transducer Assembly
Figure 1. Site~Rite* 5 System Block Diagram
External AC
Adapter
OR
Power Source
Base Unit
Battery/ AC
Adapter
Scanner Assembly Transducer
Assembly

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Technical Manual
3.1 Power Source
The power source supplies 15 volts direct current (VDC) nominal to the Scanner Assembly.
Power source options include an External AC Adapter or a Base Unit Battery Assembly. The
Base Unit Battery assembly contains a battery and built-in AC Adapter that permits portable sys-
tem operation. Both power supply options provide power to the scanner and charge the internal
battery simultaneously.
Figure 2. Site~Rite* 5 Power Architecture

14 Site~Rite*5 Ultrasound System
3.2 Scanner Assembly
The Scanner Assembly transmits and receives electrical ultrasound data that is used to form a
coherent image. A high-level block diagram of the system is shown in Figure 2.
NOTE: The Scanner Assembly is NOT field serviceable. If a problem is found with the Scanner Assembly
please contact Bard Access Systems at [phone].
3.3 Transducer Assembly
The Transducer Assembly converts electrical signals to acoustic pulses that are transmitted into the
body. The pulses reflect off the target and return to the transducer, which converts the acoustic data
back into electrical data. The electrical data is then transmitted to the scanner assembly where an
ultrasonic image is generated from multiple pulse echo frames.
NOTE: The transducer assembly is NOT field-serviceable. If a problem is found with the transducer
please contact Bard Access Systems at [phone].
Main Unit
USB and Power
Connector Ports
Probe Connector
- 156 pin interface
- ZIF connection type
Site~Rite* 5 Hardware
Design Elements
3 Boardmain System, contains:
1 - ETX style PCB interface board
1 - Analog Pulser Board
1 - Digital Control Board
Internal Power
Supply
- Charge Control PCB
- LION Battery
12” LCD Screen
- 12V Back Light Inverter
- .060” thick clear acrylic screen
cover
Button Panel
- LED power indicator
- Ribbon cable connects panel
to PCB
User Interface
Board
Cooling Fan
Figure 2. Scanner Assembly
Block Diagram

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Technical Manual
3.4 Front Panel Controls
On/Off/Reset
Freeze
(In Time Set mode, this button
sets the internal clock to the
displayed values and returns
the system to Run Mode.)
Increase Gain
(In Time Set mode, this
button increases or toggles
the selected field.)
Decrease Gain
(In Time Set mode, this
button decreases or
toggles the selected field.)
Depth
(In Freeze mode,
if this button is
held for more than
5 seconds, the
system enters the
Time Set mode. In
Time Set mode,
this button selects
the next field.)
Depth Markers
Toggles depth
markers on/off.
Print
Sends the current
image to the printer if
connected. If a USB
storage device is con-
nected to the system,
this button will also
save the current
screen image to the
storage device.

16 Site~Rite*5 Ultrasound System
3.5 Display Screen Information
Probe Depth Indicator
Indicates current
image depth.
Gain Indicator
Shows gain levels
from 0-100%.
Run/Freeze Indicator
When the system is in freeze mode, the indicator is shown
in red and blinks briefly every second.
Depth Marker Indicator
When depth markers are enabled, the indicator is highlighted in
light green.
Storage Device Indicator
When a storage device is connected, the indicator icon is shown in solid grayscale. When
the storage device is full or has errors, the indicator is displayed with a red “!” overlay.
Printer Indicator
When a printer is connected, the indicator is shown in solid grayscale. If the printer has an
error condition, the indicator is displayed with a red “!” overlay.
Time and Date
The time is shown in 24 hour “00:00”
format and the date may be displayed in
MM/DD/YY or DD.MM.YY format.
Image Depth Markers
When enabled, the depth markers are
shown as green dots superimposed on
the image at 1.0 cm pitch with smaller
dash marks at 0.5 cm.
Probe Orientation Marker
Mechanical Index
The mechanical index is shown in
increments of 0.1 with an accuracy
of +/- 0.09.

17
Technical Manual
Display Screen Information (continued)
4 Installing Site~Rite*5 Software
The Site~Rite* 5 Ultrasound System allows software installation through the USB connectors located on
the rear of the scanner.
To install software:
1. Press the Freeze button ( ) to pause the system.
2. Insert a USB drive into one of the USB connectors located on the rear of the Site~Rite 5 scanner.
3. Wait until the storage device icon is illuminated before proceeding.
4. Simultaneously press and hold the Gain buttons ( ) until the configuration screen appears.
5. When the configuration screen appears, simultaneously press and hold the Depth button ( cm ) and
Depth Marker button ( /:\ ) until the software installation process begins.
Note: The Site~Rite 5 System will automatically upload the software from the attached USB drive.
Note: The screen will appear blank and/or inactive during the software installation process.
6. When a blinking cursor appears, power off the Site~Rite 5 scanner.
7. Disconnect the USB drive.
8. Power on the Site~Rite 5 scanner.
9. Verify that the correct software version appears on the upper left hand corner of the screen.
10. Resume normal operation.
AC Power Indicator
The indicator is shown in solid grayscale when connected to AC wall power and
is shown as a dark gray outline when disconnected.
Battery Indicator
The 5 charge levels for the batteries are displayed as shown. When the unit is
recharging, the indicator is green for all 5 levels. When the unit is under battery
power, the console battery indicator changes to yellow at 40% and red/blinking
at 20% of remaining life. If a battery malfunction is detected, the system will
show the battery with a red “!” overlay.