Bard Site-Rite 5 User manual

0712928 0605R
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.
Cidex is a registered trademark of Johnson and Johnson Medical, Inc.
U.S. Patent: 5,235,987; U.S. Patents Pending.
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

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
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
Humidity Parameters Class II Equipment

3
Instructions For Use
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
Table of Contents
1 Overview
1.1 Indications For Use
1.2 Site~Rite*5 Ultrasound System and Components
1.3 Warnings, Precautions and Notes
2 Assembling the Site~Rite*5 Ultrasound System
2.1 Roll Stand Options
2.2 Assembling the Roll Stand
2.3 Attaching the Site~Rite*5 Scanner to Approved Roll Stands
2.4 Adjusting the Scanner
2.5 Attaching the Power Source and Charging the Battery
2.6 Connecting and Disconnecting Site~Rite*5 Probes
2.7 Powering on the Site~Rite*5 Ultrasound System
2.8 Resetting the Site~Rite*5 Ultrasound System
3 Site~Rite*5 System Information
3.1 Front Panel Controls
3.2 Display Screen Information
3.3 Back Panel
4 Using the Site~Rite*5 Probe
4.1 Probe Orientation
4.2 Draping the Probe for Sterile Use
4.3 Ultrasound Guidance for Vascular Access
Section

5
Instructions For Use
Table of Contents
5 Settings
5.1 Date, Time and Image Size
5.2 Image Parameters
6 Installing Software
7 Calibrating the Internal Battery
8 Warranty
9 Technical Specifications
9.1 Operating and Storage Conditions
9.2 Scanner Specifications
9.3 Probe Acoustic Output Specifications
9.4 Probe Specifications
9.5 Power Supply Specifications
9.6 Standards Information
10 Disposal Information
Section

6 Site~Rite*5 Ultrasound System
Site~Rite*5 System - Important Information
Warning: Do not use for ophthalmic indications. Ophthalmic use may cause patient injury.
Warning: Do not remove outer protective covers from the Site~Rite 5 scanner. Hazardous
voltages exist at several points within the system.
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: 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.
Troubleshooting & Error Screens
Cause: Scanner does not recognize or identify a probe or probe not attached.
Solution: Ensure that a Site-Rite 5 probe is properly connected to the system.
Cause: Scanner is not operating within normal parameters.
Solution: Discontinue use immediately. Return to authorized repair facility.
Cause: Display malfunction.
Solution: 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.
Cause: Battery empty.
Solution: Connect system to AC outlet for operation and battery recharge.
Cause: Battery malfunction.
Solution: Send system to authorized repair facility for battery replacement.
Cause: 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.
Solution: Replace storage device.
Cause: 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.
Solution: Check paper or service printer.
Missing/
Invalid Probe
System
Malfunction
Display
Malfunction
White
Screen
Battery
Empty
Battery
Malfunction
Storage Device
Indicator
Printer
Indicator

7
Instructions For Use
Service and Repair
Warning: Only qualified personnel should attempt to service this equipment. The Site~Rite 5
System 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 Ultrasound 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.
For servicing information or to return your Site~Rite* 5 Ultrasound System for repair, please contact
Bard Access Systems Technical / Clinical Support at [phone].

8 Site~Rite*5 Ultrasound System
Cleaning Procedures
To clean the scanner, probe and combination A/C adapter and battery charger:
1. Turn off the system.
2. Dampen a nonabrasive cloth with either warm water or rubbing alcohol.
3. Gently wipe the dampened cloth over exterior surfaces requiring cleaning.
Disinfection Procedures
The Site~Rite 5 probe may be liquid disinfected by soaking it in Cidex® plus 28 day solution.
Follow the solution manufacturer's recommendations for soak time necessary to achieve the desired
germicide level of activity.
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.
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.
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: Hot water (in excess of 113°F or 45°C) may damage the probe.
Caution: Use only Bard Access Systems cleaning and disinfection procedures. Failure to do so may
damage the device.
Note: When cleaning the system and components, it is important to remove all particles or other
matter from all surfaces and crevices.

9
Instructions For Use
1 Overview
1.1 Indications For Use
The Site~Rite 5 Ultrasound System with associated probe and accessories provide ultrasound
guidance for placement of needles and catheters in vascular structures. Ultrasound guidance
may occur intraoperatively or percutaneously. Ultrasound imaging of vascular structures, various
organs and structures of the body may also be performed.
1.2 Site~Rite*5 Ultrasound System and Components
The Site~Rite 5 Ultrasound System is an easy to use and portable ultrasound scanner.
Site~Rite 5 Ultrasound System and Accessories include:
• Site~Rite 5 scanner
• Site~Rite vascular access probe
• Site~Rite standard roll stand
• Site~Rite collapsible roll stand
• Site~Rite VAD bedside roll stand
• Site~Rite 5 printer
• Site~Rite needle guides
• Site~Rite disposable probe covers
• Combination Site~Rite A/C adapter and battery charger
• Roll stand mounted battery
• Ultrasound gel
• Ultrasound vessel phantom
Contact your Bard Access Systems' Sales Representative or Customer Service at [phone] to order.

10 Site~Rite*5 Ultrasound System
1.3 Warnings, 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.

11
Instructions For Use
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 system 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.

12 Site~Rite*5 Ultrasound System
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
formulated for use in medical applications, to the acoustic window (or face) of the
probe.

13
Instructions For Use
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.

14 Site~Rite*5 Ultrasound System
Precautions (continued)
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.
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.

15
Instructions For Use
2 Assembling the Site~Rite*5 Ultrasound System
Unpack the Site~Rite*5 System and verify the contents against the packing slip. Inspect all parts for damage. If
any damage is found, please contact Bard Access Systems at 800-443-3385.
2.1 Roll Stand Options
Collapsible
Roll Stand
Standard
Roll Stand
VAD Bedside
Roll Stand
Warning: Maximum
shelf load on the VAD
bedside roll stand is
22 lbs. Exceeding this
weight may damage
the roll stand.

16 Site~Rite*5 Ultrasound System
2.2 Assembling the Roll Stand
Step 1:
Attach probe holder to probe arm as shown.
Step 2:
Attach Probe Arm to monitor mounting
plate using rear two holes only as shown.
Step 4:
Using two screws removed in Step 3 mount
Monitor Plate and Probe Arm assembly to
Swivel Mount assembly as shown.
Step 3:
Remove two screws from Swivel Mount
assembly as shown.

17
Instructions For Use
Assembling the Roll Stand (continued)
Step 5:
Route cord in the lower rear corner of monitor
mounting plate assembly as shown.
Step 6:
Start two screws in the top two monitor
mounting locations as shown.
Step 7:
Slide monitor onto monitor mounting plate, insert
two screws in lower mounting locations and tighten
all four screws. Be sure that cable is routed below
monitor and moves freely.
Step 8:
Plug in cord as shown.