
Site~Rite
®
8 Ultrasound System
Page 8
2.2. Cue™ Needle Tracking System Warnings (if enabled)
Warning:
Use only Cue™ Needle Tracking System compatible needles with the Cue™ Needle Tracking System.
Use of unapproved needles may result in patient injury.
Warning:
Misuse of the Cue™ Needle Tracking System may result in damage to the equipment or personal injury.
Warning:
Cue™ Needle Tracking is not qualified for use with Site~Rite
®
Needle Guides. Using Site~Rite
®
Needle
Guides with Cue™ Needle Tracking may result in injury to the patient.
Warning:
The Cue™ Activator contains strong magnets which may affect devices sensitive to magnetic fields.
2.3. Pinpoint™ GT Needle Technology Warnings (if enabled)
Warning:
Use only Pinpoint™ GT Needles with the Pinpoint™ GT Needle Technology. Use of unapproved needles
may result in patient injury or equipment damage.
Warning:
Pinpoint™ GT Needle Technology is not qualified for use with Site~Rite
®
Needle Guides. Using Site~Rite
®
Needle Guides with the Pinpoint™ GT Needle Technology may result in injury to the patient.
Warning:
Misuse of the Pinpoint™ GT Needle Technology may result in damage to the equipment or personal injury.
2.4. Site~Rite® 8 Ultrasound System Cautions
Caution:
To avoid unnecessary strain on the user, use the medical device in a manner that is comfortable.
Caution:
During use, the AC connector needs to be easily accessible. In case of emergency, remove the power
cord as soon as possible.
Caution:
Do not force connections; improper installation may damage the connector or system.
Caution:
Use only Bard Access Systems cleaning and disinfection procedures. Failure to do so may damage the
device.
Caution:
Use only approved or recommended cleaners or disinfectants to avoid damaging the device.
Caution:
Do not attempt to sterilize the Site~Rite
®
8 Ultrasound System or probe; damage to the equipment may
occur as a result.
Caution:
When attaching the system to the roll stand or kickstand, do not over-tighten the screws; doing so may
damage the system.
Caution:
Use only the screws provided in the packaging. Ensure the unit is secure against the roll-stand or
kickstand mount. Failure to do so may cause the display to disconnect from the mount.
Caution:
The Site~Rite
®
8 Ultrasound System contains an internal battery. Dispose of dead battery packs in
accordance with local regulations; improper disposal may present an environmental hazard.
Caution:
Do not allow liquid to enter the system, AC adapter, connectors, or ports; damage to the equipment may
occur.
Caution:
Only qualified personnel should attempt to service this equipment. The Site~Rite
®
8 Ultrasound System
contains static sensitive components and circuits. Failure to observe proper static-control procedures may
result in damage to the system.
Caution:
To avoid damage to the device operating system, shut down the device through the power
control window (see Section 5).
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
®
8 Ultrasound System acoustic-output parameters fall well below all US Food and Drug Administration
(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 principles of ALARA.
Caution:
Hot water (in excess of 113°F or 45°C) may damage the system or the probe.
Caution:
Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
Caution:
Cardiac-rhythm disturbances during perfusion studies using gas ultrasound contrast agents have been
observed in the diagnostic range of Mechanical Index (MI) values. See the specific package insert for the
specific contrast agent being used for details.
Caution:
Do not twist, bend, swing, or pull the probe cable in excess of that required during normal use of the probe.
Excessive force on the cable may cause equipment failure, intermittent operation, or unpredictable
operation.
Содержание Site-Rite 8
Страница 1: ...Instructions for Use...