Important Safety Instructions - lumithera VALEDA Bedienungsanleitung

7. Important Safety Instructions

Valeda is a medical device and should be operated only by qualified medical professionals in
accordance with this manual and any applicable country or local laws and regulations. Prior to
using Valeda, be sure to review all described warnings and entire instructions for use. Failure to
follow the warnings may result in injury to the patient or operator or cause property damage.
It is the responsibility of the operator and the institution or organisation where Valeda will be
operated to comply with their safety standards concerning the use of this system.
Warnings
Warnings are information relating to potential dangers when using Valeda.
• Do not use the system if damage is observed or if the system is not operating as expected.
• Do not modify the system.
• Use only the power cord provided with the system or supplied by LumiThera.
• Do not use the power cord if it has been damaged. Use of a damaged power cord may result in a
fire or electrical shock hazard.
• To avoid the risk of electrical shock, the system must be connected only to supply mains with
protective earth.
• Do not treat patients with open sores that may come into contact with the system.
• Do not use this system on any part of the body other than designated treatment sites.
• Disconnect power to the system before cleaning.
• Patients should remove their glasses and contact lenses prior to treatment.
Cautions
Cautions are important information to prevent possible harm when using Valeda.
• Use only the accessories specified for use with this system. Use of accessories not
specified for use with this system may impair pe ormance.
• Only connect a Valeda LumiKey to the system USB port. Connection to other equipment
could result in previously unidentified risks to patients, operators or third parties. The
manufacturer has implemented measures to control risks related to USB port connections.
Changes to the USB port connection can introduce new risks.
• In the event of an emergency in which power to the system must be shut o , either turn
o the power switch or unplug the system from the electrical source.
• Do not attempt to disassemble Valeda.
Precautions
Precautions are important information for alerting the operator to exercise special care necessary
for the safe and e ective use of Valeda or a measure taken in advance to avert possible harm or
misfortune.
• This device has not been tested for use on pregnant women.
• Do not spray or pour cleaning agents directly on Valeda.
• Do not use abrasive agents to clean Valeda.
Information
The following useful information is related to the operation of Valeda.
• There are light emitting diodes (LEDs) in Valeda emitting at 590, 660 and 850 nm from the light
aperture. Valeda has been designed to limit LED output to be within acceptable industry
standards (IEC 62471) for eye safety.
Clinical Data
Information related to the clinical safety and e icacy of Valeda can be found in the LumiThera
Report of Prior Investigations and is available upon request.
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