Adverse Events; Table 14 Clinical Risks And Recommended Mitigation Steps - Clarity RetCam3 User Manual

is not subject to the predictable inaccuracies associated with the current practice of
viewing a structure and subsequently making hand written notes and/or paper sketches or
drawings in an attempt to record what was seen.
Digital images are readily available for direct comparisons over time. As the images are
captured at various intervals, they can be displayed side by side on a screen, allowing the
physician to track the progress of disease and determine the need for any intervention.
These permanent images can become a part of the patient's medical record.

Adverse Events

The RetCam Imaging System has been used in over 85 countries and more than 1,000
devices have been distributed worldwide. It is estimated that over 2.5 million eye imaging
examinations have been performed with the RetCam Imaging System. The RetCam
Imaging System has an excellent record of safety; however, as with any medical device it
is not possible to completely eliminate all anomalies.
that could conceivably occur, and includes the recommended steps to mitigate each of
them.

Table 14 Clinical Risks and Recommended Mitigation Steps

Risk
Cross Contamination
Physiological Stress
Ocular Pressure
RetCam 3 and RetCam Shuttle User Manual
Screening for Retinopathy of Prematurity (ROP)
Mitigation
Infants in a NICU may be particularly vulnerable. Infection control in any acute care
setting is of paramount concern. Standard techniques to reduce cross
contamination include strict hand washing procedures and adherence to policies in
keeping with the institution's standard practice. RetCam users should wear gloves.
The RetCam lens must always be cleaned according to Clarity's instructions before
and after each patient.
NICU infants are particularly subject to the risk of physiological stress from any
procedure. One highly effective way to avoid undue stress as a result of a RetCam
evaluation is to assure that the user is qualified by education and experience to
perform the evaluation. Training in the use of the RetCam System is mandatory.
Those personnel who are the medical/nursing staff in a NICU setting are uniquely
sensitive to the special needs of stress avoidance for their patients as well as
monitoring stress experience by their patients. Preparation of the infant and the
environment are strongly recommended. Careful ergonomic positioning of the
RetCam relative to the patient and user is important to facilitate an efficient
screening procedure. The selection of a lid speculum appropriate for the size of the
infant and the gentle insertion of it minimizes stress prior to and during the
examination. The combination of qualified, trained personnel and a well-planned
procedure greatly reduces the risk of physiological stress. Training modules are
available on line at www.claritymsi.com.
Only gentle contact between the coupling gel and the lens is necessary to create an
optical bridge that effectively couples the light. Physical contact with the cornea
should be avoided. Undue pressure on the eye may interfere with visualization and
may be uncomfortable for the infant increasing stress. The user must be qualified
by education and experience to perform the imaging examination. Training in the
use of the RetCam System is mandatory. Follow-up and advanced user training is
also available. Training modules are available on line at www.claritymsi.com.
Table 14 identifies three clinical risks
PN 18-000393 Rev. A
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