ADC 5110N User Manual
Pocket Diagnostic Instruments
Use, Care, & Maintenance
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 Series, 5110E, 5111N
Series, 5112N Series).
Device Description and Intended Use
Ophthalmoscope attachment (5110N Series, 5110E, 5112N Series)
The ophthalmoscope is a handheld, 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 Series, 5110E, 5111N Series)
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 not made with natural rubber latex.
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.
2
Symbol Definitions
LATEX
The following symbols are associated with your diagnostic instrument.
Symbol Definition
for Cautions and Instructions
for Use.
Conforms to EU Standards
Attention. Read Operating Manual
Not made with natural rubber latex
Symbol Definition
Represenative’s Information
Manufacturer’s Information
TYPE B. Indicates this is a product
with Type B applied parts
Do not dispose of this product
as unsorted municipal waste
Authorized European
General Warnings
A warning statement in this manual identifies a condition or practice which, if
not corrected 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.
3
CAUTION: Do NOT immerse the battery handle in liquid. Consult the cleaning and disinfection instructions 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 healthcare practitioner.
CAUTION: Turn off instrument when not in use. Avoid powering on without an instrument head
attached. When storing this device for extended periods of time, remove the batteries.
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 (including internal liners) can NOT be cleaned or disinfected and should be safely discarded if contaminated. Do not carry the case into a contaminated environment.
WARNING: When replacing lamp, allow lamp to cool for five minutes before handling.
WARNING: Only the approved sterilization method included in this IFU has been vali-
dated for this device or its corresponding components. Any other sterilization method
may compromise the safety and effectiveness of this device. (This includes steam sterilization.)
WARNING: Do NOT place devices or accessories back into carrying case after use on a
patient without first cleaning/disinfecting the device/accessories as described in the cleaning and disinfection section of this manual. Carry case liners can NOT be cleaned or disinfected and should be discarded if contaminated.
WARNING: Use of any accessories or materials not indicated in the user's manual can
degrade the minimum safety of the equipment.
WARNING: Only replace listed accessories (attachments), lamps, or batteries for the device.
WARNING: During use metal components near instrument head can become warm. This
is especially true if device is on for extended periods of time. Do not leave device on when
not in use.
WARNING:The light emitted from this instrument is potentially hazardous. The longer the
duration of exposure, the greater the risk of ocular damage. Exposure to light from this
instrument, when operated at maximum intensity, will exceed the safety guideline after
3 minutes and 47 seconds. Exposure times are cumulative for a 24 hour period.
4
Loading...