Bard Site-Rite 6 User manual

ACCESS SYSTEMS
INSTRUCTIONS FOR USE
REF 9770000

INSTRUCTIONS FOR USE

2 Site~Rite*6 Ultrasound System
Do not operate in the presence
of flammable anesthetics
BF Type Equipment
Federal (U.S.A.) law restricts
this device to sale by or on the
order of a physician
Rx Only
Dangerous Voltage Attention, see
instructions for 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
Storage Humidity Parameters
(packaged)
Operating Humidity Parameters
Storage Humidity Parameters
(unpackaged)

3
Instructions For Use
10
o
C
38
o
C
Storage Temperature
Parameters
Fragile
15
o
C
38
o
C
Operating Temperature
Parameters
Ultrasound Probe
Do not dispose with
ordinary municipal waste
Keep Dry
Direct Current Federal Communications
Commission
Manufacturer

4 Site~Rite*6 Ultrasound System
Table of Contents
1 Overview
1.1 Indications For Use
1.2 Site~Rite*6 Ultrasound System and Components
1.3 Warnings, Precautions and Notes
2 Assembling the Site~Rite*6 Ultrasound System
2.1 Assembling the Roll Stand
2.2 Adjusting the Scanner on the Roll Stand
2.3 Attaching the Power Source and Charging the Battery
2.4 Connecting and Disconnecting Site~Rite*6 Ultrasound System Probe
2.5 Powering on the Site~Rite*6 Ultrasound System
2.6 Resetting the Site~Rite*6 Ultrasound System
3 Site~Rite*6 Ultrasound System Information
3.1 Front Panel Controls
3.2 Probe Controls
3.3 Display Screen Information
3.4 Back Panel
3.5 Entering Patient Information
4 Using the Site~Rite*6 Ultrasound System Probe
4.1 Probe Orientation
4.2 Draping the Probe for Sterile Use
4.3 Ultrasound Guidance for Vascular Access
5 Settings
5.1 Date, Time and Image Size
Section

5
Instructions For Use
Table of Contents
5.2 Image Parameters
5.3 Sizing Tools
5.4 Image Depth
5.5 Image Gain
6 Cleaning and Disinfection
6.1 Cleaning Procedures
6.2 Disinfection Procedures
7 Troubleshooting & Error Screens
8 Upgrading Software
9 Calibrating the Rechargeable Batteries
10 Warranty
11 Service and Repair
12 Technical Specifications
12.1 Operating and Storage Conditions
12.2 Scanner Specifications
12.3 Probe Acoustic Output Specifications
12.4 Probe Specifications
12.5 Power Supply Specifications
13 Standards Information
14 Disposal Information
15 EMC Tables
Section

6 Site~Rite*6 Ultrasound System

7
Instructions For Use
1 Overview
This manual provides instructions for the proper use of the Site~Rite* 6 Ultrasound System.
Clinicians must have ultrasound training prior to operating this system. For additional information or
product training, contact your local Bard Access Systems sales representative.
1.1 Indications For Use
The Site~Rite* 6 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*6 Ultrasound System and Components
The Site~Rite* 6 Ultrasound System is an easy to use and portable ultrasound scanner.
Site~Rite* 6 Ultrasound System and Authorized Accessories include:
•Site~Rite*6UltrasoundSystemscanner
•Site~Rite*6UltrasoundSystemvascularaccessprobe
•Site~Rite*6UltrasoundSystemrollstand
•Site~Rite*6UltrasoundSystemprinter
•Site~Rite*6UltrasoundSystembasepowerunit
•Site~Rite*6UltrasoundSystemA/Cadapter
•Site~Rite*6UltrasoundSystemlinecord
•Site~Rite*needleguides
•Site~Rite*probecovers
•Ultrasoundgel
•Ultrasoundvesselphantom
•USBstoragedevicewithnoexternalpowerconnection(e.g.USBflashdrive)
Contact your Bard Access Systems' Sales Representative or Customer Service at [phone] to order.

8 Site~Rite*6 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* 6 Ultrasound System
 scanner.Hazardousvoltagesexistatseveralpointswithinthesystem.
Warning: Do not operate the Site~Rite* 6 Ultrasound System or the Site~Rite* 6 Ultrasound
 Systempowersources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* 6 Ultrasound System may result in damage to the equipment
or personal injury.
Warning: Use only the Site~Rite* 6 Ultrasound System A/C adapter to charge the Site~Rite*
6 Ultrasound System. Use of any other device to charge the Site~Rite* 6 Ultrasound
System may damage the battery packs, may cause intermittent or unpredictable
operation, may damage the system, may result in injury 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* 6 Ultrasound System 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, A/C adapter, base power unit, probe
connector or probe port. Damage to the equipment may occur.

9
Instructions For Use
Warnings (continued)
Warning: Do not attempt to sterilize the Site~Rite* 6 Ultrasound System scanner or probe 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 environmental hazard.
Warning: Only qualified personnel should attempt to service this equipment. The Site~Rite*
6 Ultrasound 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* 6 Ultrasound System and
may result in injury or equipment damage:
 • Openingorservicingthescannerortheprobehousingbyanyoneotherthan 
Bard Access Systems authorized service personnel.
 • RemovalofsystemlabelsbyanyoneotherthanBardAccessSystemsauthorized
service personnel.
 • OpeningorservicingthebasepowerunitortheA/Cadapterbyanyoneotherthan
Bard Access Systems authorized service personnel.
 • ConnectingtheSite~Rite*6UltrasoundSystemscannertoanypowersourceother
than the Site~Rite* 6 Ultrasound System A/C adapter and/or base power unit.
 • ConnectingtheSite~Rite*6UltrasoundSystemtoanyunauthorizedaccessory.
Refer to Section 1.2.
Warning: Inspect power cords for damage. If any of the prongs are damaged, use battery power
until a 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 only relies on basic insulation should not be used with this system.
Failure to comply could result in increased patient risk.

10 Site~Rite*6 Ultrasound System
Warnings (continued)
Warning: MaximumshelfloadontheVADbedsiderollstandis22lbs.Exceedingthisweightmay
damage the roll stand.
Warning: Do not overtighten screws when attaching the scanner to the roll stand mount. Doing so
may damage the scanner.
Warning: Use only screws provided in the packaging. Ensure the unit is secure against the roll
stand mount. Failure to do so may cause the scanner to disconnect from the roll stand.
Warning: Do not use the probe with high frequency surgical equipment. Doing so may damage the
equipment.
Warning: Do not pull on the probe cable or overload the roll stand. Doing so may cause the system to
tip.
Warning: The keyboard tray and arm are designed to support the keyboard weight only. Additional
weight may cause the stand 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* 6 Ultrasound System 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: Inspect the keyboard prior to each use. If damage is noted, do not use the keyboard.

11
Instructions For Use
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.
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, inspect the integrity of all power cords and connectors as well as
the integrity of the unit itself. If any problems are found, discontinue use immediately
and contact an authorized service representative. Use of a damaged power cord could
damage the machine.
Caution: During use, the A/C connector needs to be easily accessible. In case of emergency
remove the power cord as soon as possible.
Caution: To avoid unnecessary strain, use the device in a comfortable manner.

12 Site~Rite*6 Ultrasound System
Precautions (continued)
Caution: Attach the 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.

13
Instructions For Use
2 Assembling the Site~Rite*6 Ultrasound System
Unpack the Site~Rite*6 Ultrasound 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 Assembling the Roll Stand
Refer to roll stand assembly instructions.
2.2 Adjusting the Scanner on the Roll Stand
Tilt and Swivel Adjustment

14 Site~Rite*6 Ultrasound System
2.3 Attaching the Power Source and Charging the Battery
Warning: Use only the Site-Rite* 6 Ultrasound System A/C adapter to charge the Site-Rite*
6 Ultrasound System . Use of any other device to charge Site-Rite* 6 Ultrasound
System may damage the battery packs, may cause intermittent or unpredictable
operation, may damage the system, may result in injury and will void your warranty.
Warning: Always properly dispose of dead battery packs in accordance with local regula-
tions. Improper disposal may present an environmental hazard.
Warning: Inspect power cords for damage. If any of the prongs are damaged, use battery
power until a replacement cord is obtained.
Caution: Attach power source in such a way as to prevent damage. Improper installation
may damage power cords.
When the Site~Rite* 6 Ultrasound
System is attached to A/C power, the
battery charges automatically.

15
Instructions For Use
2.4 Connecting and Disconnecting the Site~Rite*6 Ultrasound System Probe
2.5 Powering on the Site~Rite*6 Ultrasound System
To power on the Site~Rite*6 Ultrasound System
1. Verify that the probe is connected to the Site~Rite* 6 Ultrasound System scanner.
2. Depress and release the power button located on the front of the Site-Rite* 6 Ultrasound
System scanner.
3. Waitapproximately20secondsforthedisplayscreentoilluminate.
4. To power off the Site~Rite* 6 Ultrasound System, depress and release the power button
again. The system is powered off when the display screen darkens.
Warning: Use only Bard Access Systems probes with this system. Use of unapproved probes may result in patient
injury or equipment damage.
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.
1. 2. 3.

16 Site~Rite*6 Ultrasound System
3 Site~Rite*6 Ultrasound System Information
3.1 Front Panel Controls
Freeze Image
(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 but-
ton is held for more than 5
seconds, the system enters
the Time Set mode. In
Time Set mode, this button
selectsthenextfield.)
Depth Markers
Toggles between depth mark-
ers, gridlines and off. Hold
for more than 5 seconds to
toggle between the low and
high contrast image.
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.
2.6 Resetting the Site~Rite*6 Ultrasound System
Shouldthescannerdisplayeverappearblankorshowanexclamationmark(!), the system may
need to be reset.
To reset the system:
1. Depress and release the power button located on the front of the Site~Rite* 6 Ultrasound
System scanner.
2. Waitapproximately60secondsfortheunittoresetitself.
3. Powertheunitbackonperinstructionsinsection2.5.
On/Off/Reset

17
Instructions For Use
3.2 Probe Controls
Depth
Decrease Gain
Freeze Image
Hold for more than 5 seconds to print
or save the image on the screen
On/ Off/ Reset
Increase Gain

18 Site~Rite*6 Ultrasound System
3.3 Display Screen Information
Probe Orientation Marker
Time and Date
The time is shown
in 24 hour “00:00”
format and the date
is displayed in YYYY-
MM-DD format.
Catheter Size Icons
Displayed in proportion
to the vessel image
at a selected depth.
Icons assist clinicians
in determining the ap-
propriate catheter size
for the vessel being
imaged.
F9 toggles Catheter
Size icons on and off.
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.
Software Version Number
Patient ID 1 Display
Smooth/Sharp
Image
F5 on the keyboard
toggles between
smooth and sharp
imaging filters
Enter Patient
Information
F1 on the keyboard
opens the patient
information screen
Erase Patient
Information
F12 on the keyboard
erases patient
information