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Bard Site-Rite 5 Technical Manual

Site~Rite* 5 Ultrasound System Manufactured by:
Bard Access Systems, Inc. Salt Lake City, UT 84116 U.S.A.
(801) 595-0700 Customer Service: (800) 545-0890 Technical/Clinical Support: (800) 443-3385 Fax: (801) 595-4948
www.bardaccess.com

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.

0712929 0605R

Site~Rite* 5 Ultrasound System Do not operate in the presence of flammable anesthetics Dangerous Voltage
BFType Equipment
Do Not Dispose of Battery Pack In Fire
Humidity Parameters

Dot Markers Active
Warning: Refer to Manual Before Use
Power/Stand-by
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
ACAdapter
Class II Equipment

Freeze Image

Technical Manual

Prescription Only

Battery Pack

Fragile

10o C

35o C Storage Temperature
Parameters

15o C

38o C Operating Temperature Parameters

Ultrasound Probe

Depth (In Centimeters)

Gain

Do not dispose with ordinary municipal waste

Site~Rite* 5 Ultrasound System

Technical Manual

Table of Contents
Section
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

Site~Rite* 5 Ultrasound System
1 Warranty
The manufacturer, Bard Access Systems, warrants this product against defects in material and workmanship 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 damages 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.

Technical Manual

2 Warnings, Precautions and Notes

Warnings

Warning: Warning: Warning:
Warning: Warning: Warning:
Warning:
Warning: Warning: Warning:

This product should only be operated by qualified medical personnel.
Do not remove outer protective covers from the Site~Rite* 5 scanner. Hazardous voltages exist at several points within the system.
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.
Do not use for ophthalmic indications. Ophthalmic use may cause patient injury.
Misuse of the Site~Rite* 5 System may result in damage to the equipment or personal injury.
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.
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.
If a probe is damaged in any way, discontinue use immediately. Damage to the scanner may occur.
Avoid subjecting the probe to excessive mechanical shock. Damage to the probe may occur.
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.

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.

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:
Caution: Caution: Caution: Caution: 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.
Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
Do not pull the cable to disconnect the probe connector from the scanner. Pulling the cable may damage the cable, cable connection or scanner.
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.
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.
Only apply commercially available ultrasonic couplant, which has been specifically formulated 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: Caution: Caution:
Caution: Caution: Caution: Caution: 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.
Do not subject the probe to excessive vibration. Vibration may dislodge sensitive components and cause intermittent or unpredictable operation.
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.
Unapproved extension cords should not be used with this system. Doing so may damage the system.
During use, the AC connector needs to be easily accessible. In case of emergency remove the power cord as soon as possible.
To avoid unnecessary strain on the user, use the device in a comfortable manner.
Attach power source in such a way as to prevent damage. Improper installation may damage power cords.
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.

Technical Manual

Precautions (continued)
Caution: Hot water (in excess of 113o F or 45o C) may damage the probe. Caution: Use only Bard Access Systems cleaning and disinfection procedures. Failure to do so
may damage the device.
Notes

Note: Note:

When cleaning the system and components, it is important to remove all particles or other matter from all surfaces and crevices.
For 240 V applications use only center tapped 240 VAC single phase power.

12 Site~Rite* 5 Ultrasound System
3 Site~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

External AC Adapter

Scanner Assembly

Base Unit Battery/ AC
Adapter
Power Source

Transducer Assembly

Figure 1. Site~Rite* 5 System Block Diagram

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 system 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.

Main Unit
USB and Power Connector Ports

Cooling Fan

12" LCD Screen
- 12V Back Light Inverter - .060" thick clear acrylic screen
cover

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

Button Panel
- LED power indicator - Ribbon cable connects panel
to PCB

Internal Power Supply
- Charge Control PCB - LION Battery

User Interface Board

Figure 2. Scanner Assembly Block Diagram

NOTE: The Scanner Assembly is NOT field serviceable. If a problem is found with the Scanner Assembly please contact Bard Access Systems at (800) 443-3385.
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 (800) 443-3385.

3.4 Front Panel Controls

Technical Manual

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 connected to the system, this button will also save the current screen image to the storage device.
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.)

16 Site~Rite* 5 Ultrasound System
3.5 Display Screen Information

Mechanical Index The mechanical index is shown in increments of 0.1 with an accuracy of +/- 0.09.
Probe Orientation Marker
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 Depth Indicator Indicates current image depth.
Gain Indicator Shows gain levels from 0-100%.

Depth Marker Indicator When depth markers are enabled, the indicator is highlighted in light green.
Run/Freeze Indicator When the system is in freeze mode, the indicator is shown in red and blinks briefly every second.

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.

Technical Manual

Display Screen Information (continued)

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.

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.

18 Site~Rite* 5 Ultrasound System
5 Calibrating the Internal Battery
The Site~Rite 5 internal battery may occasionally require calibration to ensure the battery power meter is accurate. The following icon indicates that the Site~Rite 5 battery requires calibration.
To calibrate the Site~Rite 5 Internal Battery: 1. Disconnect all Site~Rite 5 power sources. 2. Power on the Site~Rite 5 scanner and operate on internal battery power until the system
powers off. 3. Connect the Site~Rite 5 scanner to the Site~Rite 5 combination A/C adapter and battery charger
to recharge the internal battery. Note: At least six hours of charge time is recommended to fully charge the Site~Rite 5 internal battery. 4. Disconnect all Site~Rite 5 power sources. 5. Power on the Site~Rite 5 Ultrasound System and operate on internal battery power until the system powers off. Note: The internal battery is now calibrated. 6. Connect the Site~Rite 5 scanner to the Site~Rite 5 combination A/C adapter and battery charger to recharge the internal battery and continue normal use.

Technical Manual

6 Troubleshooting & Error Screens

Missing/ Invalid Probe

Cause: Solution:

Scanner does not recognize or identify a probe or probe not attached. Ensure that a Site-Rite 5 probe is properly connected to the system.

System Malfunction

Display Malfunction

White Screen

Battery Empty
Battery Malfunction
Storage Device Indicator
Printer Indicator

Cause: Solution:

Scanner is not operating within normal parameters. Discontinue use immediately. Return to authorized repair facility.

Cause: Solution:
Cause: Solution: Cause: Solution: Cause: Solution: Cause: Solution:

Display malfunction. Most display malfunctions can easily be corrected by resetting the system. To do so, power off the device, wait 60 seconds, then power the system back on. If the display malfunction is not resolved by resetting the system, discontinue use and return to authorized repair facility.
Battery empty. Connect system to AC outlet for operation and battery recharge.
Battery malfunction. Send system to authorized repair facility for battery replacement.
When a storage device is connected, the icon is shown in solid grayscale. If the storage device is full or has errors, the icon is displayed with a red "!" overlay. Replace storage device.
When a printer is connected, the icon is shown in solid grayscale. If the printer has an error condition, the icon is displayed with a red "!" overlay. Check paper or service printer.

20 Site~Rite* 5 Ultrasound System

6 Troubleshooting & Error Screens Continued...

Troubleshooting Guide

Problem
The system will not power on.
(Power LED is not illuminated,
fan is not running, and no information is displayed.)

Possible Cause
Did not press power button long enough
Battery is discharged

AC Adapter is defective

Gain up and gain down buttons on scanner or probe do not work

System is in freeze mode Button pad is defective

Depth buttons on scanner or
probe do not work

System is in freeze mode Button pad is defective

Image is poor or penetration is inadequate

Scanner Assembly powers
on momentarily then shuts off

Not enough acoustic coupling gel is being used.
Fold or seam of sheath on the acoustic window of the probe.
Battery is discharged

Solution
Press the power button for at least 1 second.
Plug the unit into a known working AC outlet to operate system and charge the battery.
Plug the unit into a known working AC outlet. Verify power LED on Scanner Assembly is blinking. If not, remove AC Adapter and measure voltage levels on the DIN connector. The DIN Shield is GND. Pin 1 & 3 should read ~15VDC.
Press the freeze button.
Use scanner buttons until unit can be returned for service.
Press the freeze button.
Use scanner buttons until unit can be returned for service.
Use more coupling gel.
Smooth out sheath over the acoustic window.
Plug the unit into a known working AC outlet to operate system and charge the battery.

Technical Manual

7 Site~Rite 5* System Specifications

7.1 Operating and Storage Conditions

Operating Temperature:

59°F to 100°F (15°C to 38°C)

Storage Temperature:

50°F to 95°F (10°C to 35°C )

Operating Humidity:

5% to 85% Relative Humidity (non-condensing)

Storage Humidity (packaged): 5% to 95% Relative Humidity (non-condensing)

Storage Humidity (unpackaged): 5% to 85% Relative Humidity (non-condensing)

7.2 Scanner Specifications

Dimensions: Weight: Power Sources: Power Consumption: Monitor Size: IEC 60601- 1:

12" W x 12" H x 5" D 10 lbs. AC adapter, Internal and External DC Battery Pack 82 Watts Maximum 12.1" diagonal Class II, Type BF Applied Part, Continuous Operation, Internally Powered Equipment, Not Category AP or APG Equipment, Not protected against ingress of water.

7.3 Probe Specifications
L-VA: Frequency: Elevation Focus: Maximum Scan Depth: Scan Width: Lateral Foci:

Linear Vascular Access Probe 5 -10 MHz 1.8 cm 6.0 cm 1.9 cm

Image Depth 1.5 cm 3.0 cm 4.5 cm 6.0 cm

Focal Depth 0.6 cm 1.5 cm 3.0 cm 5.0 cm

22 Site~Rite* 5 Ultrasound System
7.4 Power Supply Specifications
Note: For 240 V applications use only center tapped 240 VAC single phase power as
shown below.

A/C Adapter Specifications

Input Voltage: Input Current (Max):

100-240 VAC, 50/60 Hz. 1 Amp

Output Voltage: Output Current (Max):

15 VDC 6 Amps

Internal Battery Pack Specifications

Battery Chemistry:

Lithium Ion

Nominal Output Voltage:

10.8 VDC

Output Current (Max):

6 Amps

Output Power (Full Charge): System Run Time on Full Charge: Charge Time (Full):

52 Wh 1.0 Hours 1.75 Hours

Combination A/C Adapter Auxiliary Battery Specifications

Input Voltage:

100-240 VAC, 50/60 Hz. Battery Output Current (Max):

6 Amps

Input Current (Max):

1 Amp

Battery Chemistry:

Lithium Ion

A/C Adapter Output Voltage:

15 VDC

Output Power (Full Charge):

95 Wh

A/C Adapter Output Current (Max): 7 Amps

System Run Time on Full Charge: 2.5 Hours

Nominal Battery Output Voltage: 10.8 VDC

Battery Charge Time (Full):

3 Hours

Technical Manual

8 Standards Information
The Site~Rite* 5 Ultrasound System is designed to comply with applicable sections of the following International Standards:
- UL 60601-1: 2003, Medical Electrical Equipment, Part 1: General Requirements for Safety - IEC 60601-1: 1988, Medical Electrical Equipment - Part 1: General Requirements for Safety - IEC 60601-1-1: 2000, Medical Electrical Equipment - Part 1-1: General Requirements for Safety -
Collateral Stanard: Safety Requirements for Medical Electrical Systems - IEC 60601-1-2: 2004, Medical Electrical Equipment - Part 1-2: General Requirements for Safety -
Collateral Stanard: Electromagnetic Compatibility - Requirements and Tests - IEC 60601-2-37:2005, Medical Electrical Equipment - Part 2-37: Particular Requirements for the Safety of
Ultrasonic Medical Diagnostic and Monitoring Equipment - NEMA UD-2:2004, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment - NEMA UD-3:2004, Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices
on Diagnostic Ultrasound Equipment - EN 55011:2000 Class A - Industrial, Scientific, and Medical (ISM) Radio-Frequency Equipment -Radio
Distrubance Characteristics-Limits and Methods of Measurement

24 Site~Rite* 5 Ultrasound System
9 Disposal Information
To return the Site~Rite* 5 System for end of life recycling, please contact your nearest Bard sales or distributor office in the country of purchase.
Warning: Always properly dispose of dead battery packs in accordance with local regulations. Improper disposal may present an environmental hazard.

Technical Manual

The information contained in this document is subject to change without notice or obligation. This document contains proprietary information that is protected by copyright. No part of this document may be photocopied, reproduced, or translated without the expressed written consent of Bard Access Systems.
Site~Rite* 5 Ultrasound System Manufactured by:
Bard Access Systems, Inc. Salt Lake City, UT 84116 U.S.A. (801) 595-0700 Customer Service: (800) 545-0890 Technical/Clinical Support: (800) 443-3385 Fax: (801) 595-4948 www.bardaccess.com
Site~Rite* Needle Guides Distributed by: Bard Access Systems, Inc. Salt Lake City, UT 84116 U.S.A. (801) 595-0700 Customer Service: (800) 545-0890 Clinical Information: (800) 443-3385 Fax: (801) 595-4948 www.bardaccess.com