KaVo EXPERTsurg LUX, Инструкция по эксплуатации

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Instructions for use EXPERTsurg LUX – 1.008.3500
3 Product description | 3.1 Intended use
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3 Product description
The EXPERTsurg LUX is a surgical controller in accordance with 21 CFR §
872.4200 (dental handpiece and accessories). The device consists of a surgical
control unit, a foot controller, a surgical motor (separate IFU) + motor cable, an
instruments tray, a holder and a tube set. As a functional principle the soft-
ware-based surgical control unit controls the speed and torque of a dental micro
motor. The unit is equipped with a pump for use of an external coolant hose for
irrigation of the working area. The surgical control unit is operated through the
buttons on the tabletop console or via foot control. The device is designed for
use in combination with the INTRA LUX S600 LED surgical motor (separate
IFU). Straight or contra-angle handpieces with a handpiece connection in accor-
dance with ISO 3964 can be connected. The instrument tray allows the dentist
to deposit the handpieces in a safe position. The holder is intended to be used
for general storage of the bottle. The tube set is needed to deliver the external
coolant from the bottle to the different handpieces. A power cord provides elec-
tric power to the unit. The EXPERTsurg LUX will be delivered with software on
the surgical control unit.
3.1 Intended use
Indications for use:
This KaVo product is intended for use in surgery to expose and dissect oral tis-
sue structures or endodontic treatments (e.g. periodontal gap, gingiva, bone,
jaw, extractions and implantations).
CAUTION
US Federal law restricts this device to sale by or on the order of a
healthcare professional / dentist.
For dental use only.
Proper Use:
NOTE
The EXPERTsurg LUX is approved for use in surgical theaters.
"Intended use" also includes compliance with all of the information in the in-
structions for use and ensuring that all inspection and servicing work is per-
formed as scheduled.
The overarching guidelines and/or national laws, national regulations and the
rules of technology applicable to medical devices for start-up and use of the
KaVo product for the indications for use must be applied and followed.
The functional safety and proper condition of the device must be checked be-
fore each use of the device.
The applicable national legal provisions must be heeded during the use of the
device, in particular the following:
▪ Applicable regulations governing the connection and startup of medical de-
vices.
▪ Current occupational safety regulations.
▪ Current accident prevention regulations.
In accordance with these regulations, the user is required to:
▪ only use equipment that is operating properly
▪ adhere to the specified intended use
▪ protect himself or herself, the patient and third parties from danger