American Diagnostic Corporation (ADC) Diagnostix 2.5v User Manual

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Thank you for choosing an ADC

®

Diagnostic set. We’re proud of the care and quality that goes into the

manufacture of each and every diagnostic instrument that bears our name. Every component has been

carefully designed to maximize performance. This booklet refers to both Otoscope and Ophthalmoscope

sets (Models 5110N, 5110E, 5111N, 5112N).

Device Description and Intended Use

Ophthalmoscope attachment (5110N, 5110E, 5112N)

The ophthalmoscope is a hand held, battery-powered device containing illumination and viewing optics

intended to examine the media (cornea, aqueous, lens, and vitreous), the retina, blood vessels, optic

nerve, and other structures of the eye. It is intended to be used by a trained healthcare professional.

Otoscope Attachment (5110N, 5110E, 5111N)

A handheld battery powered device with magnifying system that provides illumination of the ear canal

and tympanic membrane.

Latex Statement - This device and all accessories are latex free.

This device should be used by a trained healthcare professional.

Contraindications

The use of this device is contraindicated in patients who have already received prolonged or intense

light exposure, especially if the patients are infants, aphakes, or persons with diseased eyes. Excessive

exposure to light may result in patient injury. See warnings for additional information.

General Warnings

A warning statement in this manual identifies a condition or practice which, if not cor-

rected or discontinued immediately, could lead to patient injury, illness, or death.

CAUTION: Because prolonged intense light exposure can damage the retina, the use of the device for

ocular examination should not be unnecessarily prolonged, and the brightness setting should not

exceed what is needed to provide clear visualization of the target structures.

The retinal exposure dose for a photochemical hazard is a product of the radiance and the exposure

time. If the value of radiance were reduced in half, twice the time would be needed to reach the maximum

exposure limit.

While no acute optical radiation hazards have been identified for direct or indirect ophthalmoscopes,

it is recommended that the intensity of light directed into the patient's eye be limited to the minimum

level which is necessary for diagnosis. Infants, aphakes and persons with diseased eyes will be at

greater risk. The risk may also be increased if the person being examined has had any exposure with

the same instrument or any other ophthalmic instrument using a visible light source during the previous

24 hours. This will apply particularly if the eye has been exposed to retinal photography.

CAUTION: Do NOT immerse the battery handle in liquid. Consult the cleaning and disinfection in-

structions for each part for further information about cleaning and disinfecting this product. Never clean

or disinfect any device with batteries in it.

CAUTION: Federal law restricts this device to sale by or on the order of a physician or licensed health-

care practitioner.

WARNING: The carrying cases provided with these devices are intended for long term storage or transport

between facilities or when shipping devices to and from ADC’s facility for repair or servicing. Carry cases

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