Introduction - Mindray ZONARE z.one pro Instructions For Use Manual

1. Introduction

United States Federal Law restricts this device to sale by or on the order of a
licensed healthcare practitioner, licensed by the law of the jurisdiction in which
they practice, to use or order the use of this device.
Only qualified personnel should perform ultrasound scanning of human
subjects for medical diagnostics.
This ultrasound system meets the acoustic output emission guidelines established by the
U.S. Food and Drug Administration (FDA). Acoustic output quantities have been
measured, and are displayed, in accordance with the standards listed under Guidance
Documents.
Indications for Use
For FDA regions
The ultrasound system is intended for use by a qualified physician for ultrasound evaluation
of Ophthalmic; Fetal; Abdominal (renal, GYN/Pelvic); Intra-operative (abdominal,
thoracic(cardiac), and vascular); Intra-operative (Neuro); Laparoscopic; Pediatric; Small
organ (thyroid, breast, testes, etc); Neonatal cephalic; Adult Cephalic/Transcranial; Trans-
rectal; Trans-vaginal; Trans-esoph.(non-Card); Musculoskeletal (Conventional);
Musculoskeletal (Superficial); Cardiac Adult; Cardiac Pediatric; Trans-esoph. (Cardiac);
Intra-cardiac; Peripheral vessel.
For CE regions
It is intended for use in Ophthalmic, Abdominal (includes renal, GYN/Pelvic), Adult Cardiac,
Fetal, Musculo-skel (conventional), Pediatric, Peripheral Vascular, Musculo-skel
(Superficial), Adult Cephalic/ trans-cranial, Adult Cardiac, Pediatric Cardiac, Intra-operative
(Neuro, abdominal, thoracic (cardiac) and vascular (PV)), Neonatal Cephalic, Trans-rectal,
Trans-vaginal, Small Organ (Thyroid, Breast, Testes, etc), Transesophageal
Echocardiography (non-cardiac and cardiac), Urology, Laparoscopic, Contrast, 3D/4D exam.
It is intended for clinical ultrasound diagnosis and examination
Intended users include doctor, nurse, clinical technologist, radio technologist and
ultrasonographer proficient in medicine knowledge.
The diagnostic ultrasound system is applicable for adults, pregnant women, pediatric
patients and neonates.
Intended medical conditions are hospital (e.g., imaging laboratory, emergency room, patient
bedside, and operating room), medical clinic, physician's office or an imaging center
Note: The availability of application may be limited based on country or region of use.
Contraindication
None.
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