Introduction
Rolence Enterprise Inc. is an ISO 13485
certified manufacturer of Ultrasonic Scalers. All the products are FDA
registered and compliant with EN standard (CE Marking).
Conformance
to Standards:
The Rolence® ELiTEDENT® MS-30 Ultrasonic
Scaler conforms to IEC60601-1-2:2007 and IEC60601-1-1:2006.
The Ultrasonic Scaler is CE marked
corresponding to European Medical Device Directive (93/42/EEC)
Supplies
and Replacement Parts
Contact your local Rolence dealer to order
supplies or replacement parts. There are no serviceable parts included in this
device. Please contact your dealer to acquire all repairing service and
technique supports.
Caution: Equipment not suitable for use in the presence of flammable
anesthetic mixture with air or with nitrous oxide.
Caution: U.S. federal law restricts this device to sale by or on the order
of a dental professional.
Contraindications
‧ Ultrasonic Systems should…