Philips Ultrasound LLC EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
The EPIQ and Affiniti series diagnostic ultrasound systems are designed for diagnostic ultrasound imaging and fluid flow analysis of the human body. They are intended for use in clinics, hospitals, and clinical point-of-care settings for diagnosis of patients.
Indications for Use
The systems have the following indications for use:
- Abdominal
- Cardiac Adult; Cardiac Other (Fetal)
- Cardiac Pediatric
- Cerebral Vascular
- Cephalic (Adult) and Cephalic (Neonatal)
- Fetal/Obstetric
- Gynecological
- Intraoperative (Vascular) and Intraoperative (Cardiac)
- Musculoskeletal (Conventional) and Musculoskeletal (Superficial)
- Ophthalmic
- Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle)
- Transesophageal (Cardiac), Transrectal, Transvaginal, and Lung
The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. They are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed.
Manual:
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