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INDICATIONS FOR USE
Intended to Provide magnified visualization of the tissues of the vagina, cervix and
external genitalia in order to aid in selecting areas for biopsy and diagnosing
abnormalities as needed for a colposcopy exam. The EVA Pro is intended for use
in hospitals, clinics and doctor's offices.
USE ENVIRONMENT
The EVA Pro is intended for use in hospitals, clinics and doctor's offices.
USER QUALIFICATION
The handheld EVA Pro Digital Colposcope (viewing the cervix) must be used by a
physician or by medical personnel under the supervision of a physician. The user
must have received sufficient training in clinical procedures. MobileODT does not
discuss or provide explanations of clinical procedures.
CAUTION: Read all warnings and cautions provided in these instructions before
using the EVA Pro device.
DESCRIPTION
The EVA Pro Digital Colposcope provides
assistance for clinician examination of the
cervix. It is specifically designed for use in
resource-limited settings. The device is a
handheld, portable, battery-operated, with
an LCD display and optical camera to assist
diagnosis and treatment, in a safe, effective,
easy to use package with sufficient battery
life to sustain work for 4 hours. The EVA Pro
device is not intended for insertion into the
vaginal canal during colposcopy examination.
The camera remains outside the vaginal
cavity and functions comparably to a standard non-invasive colposcope in terms
of providing magnified visual assistance to the clinician. There is no patient
contact during the colposcopic examination.
Contact between the clinician and the device is mitigated through good clinical
practice of wearing protective gloves, limiting contact to intact skin protected by
operating gloves. It is well established that not only are colposcopes inherently
safe for the intended use of cervical inspection, but that they are effective both
Figure 1: The EVA Pro Digital
Colposcope
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