Safety Notes, Warnings and Precautions
Read all instructions before operating this unit. The VisCalor®
Dispenser heated composite delivery system emits high intensity
light waves and must only be used as indicated in this manual.
The VisCalor® Dispenser is a medical device which is subject to IEC
60601-1 (EN 60601-1) and EMC directives IEC 60601-1-2 (EN 60601-1-
2) Edition 4.0, as well as the 93/42/EEC Medical Device Directive. The
VisCalor® Dispenser complies with the relevant EU regulations.
The device has been shipped from the manufacturer in a safe and
technically sound condition. In order to maintain this condition and
to ensure risk-free operation, the notes and regulations in these
Instructions for Use have to be observed. To prevent damage to
equipment and risk for patients, users and third parties, the following
safety instructions have to be observed.
WARNING
• The user should test the product before use to ensure proper
functionality.
• As with any heavily used medical device, the user needs to
ensure a functional backup is readily available.
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Dispenser