Organization name

TOPCON CORPORATION

SRN

JP-MF-000003928

Manufacturer status

Active

3 warnings recorded — scroll inside the panel to see all entries.

• Warning; Electricity

  [Preventing Electric Shock and Fire]. To avoid fire and electric shock, install the instrument in a place free of water and other liquids. To avoid fire and electric shock, do not put cups or vessels containing liquids near the instrument. To avoid fire in the event of an instrument malfunction, immediately turn OFF the power switch ( ) and disconnect the power cord from the instrument if you see smoke coming from the instrument, etc. Don't install the instrument where it is difficult to disconnect the power cord from the instrument. Ask your dealer for service. To avoid electric shock and fire, do not disassemble, modify or repair the equipment. Ask your dealer for repairs. Be sure to connect the power plug to an AC 3-pin receptacle equipped with grounding. Connection to a receptacle without grounding may cause fire and electric shock in the case of shortcircuiting.

• [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-D701 is a medical device. The software and hardware has been designed in accordance with U.S., European and other international medical device design and manufacturing standards. Unauthorized modification of the Topcon SL-D701 software or hardware, or any addition or deletion of any application in any way can jeopardize the safety of operators and patients, the performance of the instrument, and the integrity of patient data.

  OTHER

• [Ensuring the Safety of Patients and Operators] 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 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-D701 has no special protection against harmful ingress of water or other liquids (classified 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 dripping), is a good method to clean the exterior surface of the enclosure.

  OTHER

Primary placement in Netherlands; available across 32 countries total.

Trade name

SL-D701 without exciter filter/barrier filter

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

04562123289589

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

4560126260100TU

Reference / catalog number

SL-D701

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z12120108SLIT LAMPS

• Class I medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.