7
1.5
Important precautions
These precautions are critical to insure safe operation and use.
a)
Do not use this device on patients who have implanted pacemakers, defibrillators, or any
other implantable devices.
b)
Do not use this device on patients suffering from Hemophilia.
c)
Use with caution on patients with heart disease, pregnant women, and young children.
1.6
Device safety classification
a)
Type of Operation mode: Continuous operating electromedical device
b)
Type of protection against electric shock: Class II equipment with internal power supply
c)
Degree of protection against electric shock: B type applied part
d)
Degree of protection against harmful ingress of water: Ordinary equipment (IPX0)
e)
Degree of safety application in the presence of a flammable anesthetic mixture with air,
oxygen, or nitrous oxide: Equipment cannot be used in the presence of a flammable
anesthetic mixture with air, oxygen, or nitrous oxide.
f)
Applied part: contra-angle , lip hook, file clip, touch probe.
The contact duration of applied part: 1 to 10 minutes.
Maximum temperature of applied part: 46.6°C.
1.7
Environmental parameters
a)
Operating ambient temperature: +5°C ~ +40°C
b)
Operating relative humidity: 30% ~ 75%
c)
Operating atmospheric pressure: 70kPa ~ 106kPa
1.8
User qualification
a)
The device must be operated in hospital or clinic by legally qualified dentists.
b)
It is assumed that the operator is familiar with root canal apex locator.
1.9
Intended use
a)
The Rooter
®
X3000 is an endo motor, an electro-medical device intended to drive
mechanical instruments intended for dental root canal treatment (endodontic files).
b)
In addition, it is intended to help to determine the working length (apex locator
functionality).
2.
Device setup instructions
2.1
Contra-angle setup
2.1.1
Before the first use and after each treatment
a)
Clean and disinfect the contra-angle (refer to Chapter 6).
b)
Lubricate the contra-angle (refer to Chapter 7.2).
c)
Sterilize the contra-angle (refer to Chapter 6).
2.1.2
Warnings
a)
Use original contra-angle only.
b)
Make sure the contra-angle is well connected before to start the motor handpiece.
c)
Do not connect or disconnect the contra-angle while the motor is running.
2.1.3
Connecting the contra-angle
1.
Align the three pins of the contra-angle with the positioning slots of the motor handpiece.
