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GENERAL SAFETY INFORMATION
CONTRAINDICATION
This instrument must not be used for the following patients:
• Patients who are hypersensitive to light.
• Patients who recently underwent photodynamic therapy (PDT).
• Patients taking medication that causes photosensitivity.
WARNING
Ensuring the Safety of Patients and Operators
Use this instrument carefully on the following patients.
• Patients who have epidemic corneitis, conjunctivitis or any other infectious disease.
• Patients who are taking medications that cause light hypersensitivity.
To avoid injury to the patient’s eye and nose, pay particular attention while operating the instrument
body. (The patient may be injured.)
The Topcon SL-D301 is a medical device. The software and hardware has been designed in accor-
dance with U.S., European and other international medical device design and manufacturing stan-
dards. Unauthorized modification of the Topcon SL-D301 software or hardware, or any addition or
deletion of any application in any way can jeopardize the safety of operators and patients, the perfor-
mance of the instrument, and the integrity of patient data.
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 maxi-
mum 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 to 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.
Equipment is not suitable for use in the presence of a Flammable Anesthetic Mixture with Air, Oxygen,
or Nitrous Oxide.
The Topcon SL-D301 has no special protection against harmful ingress of water or other liquids (clas-
sified IPX0). To avoid damage to the instrument and cause a safety hazard, the cleaning solutions,
including water, should not be directly applied to the device. Using a dampened cloth (without drip-
ping), is a good method to clean the exterior surface of the enclosure.
Handling the cord on this product or cords associated with accessories sold with this product, will expose
you to lead, a chemical known to the State of California to cause birth detects or other reproductive harm.
Wash hands after handling.
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