Light Source RLED-81

Trade name

Light Source RLED-81

04580137732648

458013773E0024C

Reference / catalog number

RLED-81

GS1

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.

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

• Z12020402LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY

1 warning recorded — scroll inside the panel to see all entries.

• DANGER ・The product is not explosion-proof; never use the product in a chemical storage or in a flammable gas atmosphere that may lead to ignition. Doing so may lead to fire or explosion. ・Never disassemble, repair, or modify the product. WARNING ・Read the instruction manual of the endoscope you use, and prepare according to the manual before use. ・Be sure to use the product in combination specified in this manual. When using in other combination, it is not guaranteed to provide the sufficient function of the product and the safety for patients and medical staffs. ・Never use the product that has a malfunction or an irregularity. it may cause malfunction of the product, electrical shock, burn, and fire. ・When the product does not function properly while being used, usage must be stopped immediately. ・Do not remove the cabinet case. Doing so may result in electric shock or injury caused by the parts inside the case. ・Exercise caution to ensure that metal objects or combustibles do not enter inside the product through the ventilation openings. Such objects may cause fire or electric shock. ・The product must be grounded. Be sure to connect the three-pole plug with grounding to the power outlet correctly to ground the product. Incorrect grounding may result in electric shock. ・When the power outlet does not have an earth electrode, be sure to use an additional protective earth conductor. ・The Product cannot be washed or sterilized. The physician treating a patient should not operate the product directly. Doing so may lead to infection. ・Never use the product in a place exposed to strong electromagnetic waves such ase a place close to a microwave therapy equipment, a short-wave therapy equipment, MRI, a transceiver, a mobile phone. It may cause malfunction. ・Never directly look at the illumination light. It may damage the eyes. ・After use, be sure to turn off the Power Switch before disconnecting the power cable. Otherwise, It may cause electrical shock, burn, and fire.

  OTHER