Bard Site-Rite 8 - WARNINGS AND CAUTIONS; System Warnings and Cautions

Site~Rite
®
8 Ultrasound System Page 5
1.3. Site~Rite® Ultrasound System Indications for Use
The Site~Rite
®
8 Ultrasound System is intended for diagnostic ultrasound imaging of the human body. Specific clinical
applications include:
• Pediatric
• Peripheral Vessel and Vascular Access
• Small Organ (breast, thyroid, parathyroid, testicles)
• Musculo-skeletal (conventional and superficial)
• Cardiac (adult and pediatric)
Typical examinations performed using the Site~Rite
®
8 Ultrasound System include:
Imaging Applications Exam Type (Adult and Pediatric)
Vessel
Assessment of vessels in the extremities and neck (e.g., jugular, carotid) leading to or
coming from the heart, superficial veins in the arms and legs (e.g., basilic, cephalic,
brachial, femoral, radial, saphenous), and vessel mapping. Assessment of superficial
thoracic vessels (e.g., axillary, innominate, subclavian)
Vascular Access
Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial line placement,
access to fistula and grafts, and general vein and artery access
Interventional Guidance for biopsy and drainage
Superficial
Assessment of breast, thyroid, parathyroid, testicle, lymph nodes, hernias, musculoskeletal
procedures (e.g., joints, ligaments, tendons), soft tissue structures, and surrounding
anatomical structures
Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology are each intended to provide visual needle
tracking to assist with ultrasound guided vascular access.
1.4. Clinical Applications for Cue™ Needle Tracking System
Clinical applications which are appropriate when using the Pinpoint™ GT Needle Technology are:
• Peripheral Vessel
• Vascular Access
1.5. Clinical Applications for Pinpoint™ GT Needle Technology
Clinical applications which are appropriate when using the Pinpoint™ GT Needle Technology are:
• Peripheral Vessel
• Vascular Access
1.6. Site~Rite® 8 Ultrasound System Components
Site~Rite® 8 Ultrasound System Components include:
• Console
• Linear 32mm Probe
• Linear 20mm Cue™ Needle Tracking System Probe
• Linear 20mm Pinpoint™ GT Needle Technology Probe
• Cue™ Activator