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T3300 Diagnostic Ultrasound System | 2 | B00601-010 4/10/17
Contact Information
Pharma Company: BenQ Medical Technology Corporation
Address: 7th floor, No. 46, Zhou-Z Street, Nei-Hu, Taipei 114, Taiwan
Manufacturer: Qisda Corporation
Address: 1st, 5th, 7th Floors, No. 159, Shan-Ying Road, Taoyuan 333, Taiwan
Website: www.BenQMedicalTech.com
Customer Service e-mail: Service@BenQMedicalTech.com
Customer Service Hotline:
Taiwan: 0800-015-533
China: +86 21-6327-7161~3 Ext. 812
International: +886 2-8797-5080 Ext. 5932
1.1 Intended Audience
This document is intended for sonographers, physicians, and biomedical engineers who operate
and maintain the system and are familiar with ultrasound techniques.
1.2 Intended Use
The T3300 is a general-purpose ultrasonic imaging instrument intended for use by a qualified
physician for ultrasound evaluation/clinical analysis etc. It can be used in the following applications:
Abdomen, Cardiology, Gynecology, Obstetric, Breast, Thyroid, Musculoskeletal, Vascular (Carotid,
Venous, Arterial), Nerve, Renal, Urology and so on.
The clinical environments where the system can be used include clinics, hospitals, and clinical point-
of-care for diagnosis of patients.
The system is intended to be installed, used, and operated only in accordance with the safety
procedures and operating instructions given in the system user information, and only for the
purposes for which it was designed.
The system should only be operated by someone who has received proper training in the use and
operation of an ultrasound system. This system produces images derived from sound echoes; those
images must be interpreted by a qualified medical professional. This system in no way interprets
these images or provides a medical diagnosis of the patient being examined.
WARNINGS
• Do not use the system for purposes other than those intended and expressly stated
above. Do not misuse the system, and do not use or operate the system incorrectly.
• Do not use the system in ophthalmology applications.
• Installation, use, and operation of the system are subject to the law in the jurisdictions in
which it is used. Install, use, and operate the system only in such ways that do not
conflict with applicable laws or regulations, which have the force of law. Use of the
system for purposes other than those intended and expressly stated here, as well as
incorrect use or operation, may relieve us or our agents from all or some responsibilities
for resultant noncompliance, damage, or injury.
• System users are responsible for image quality and diagnosis. Inspect the data that is
being used for the analysis and diagnosis, and ensure that the data is sufficient both
spatially and temporally for the measurement approach being used.