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Acteon SATELEC EndoDual Benutzerhandbuch Seite 6

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  • DEUTSCH, seite 58
Principle of operation of the medical device:
An electrical signal output by the medical device is supplied to the micromotor. The micromotor is connected to medical devic e by a lead.
The micromotor is equipped with a rotary instrument holder onto which a tool (file) is attached. The rotation of the micromotor activates
the tool.
Principal performance specifications:
"ENDO" micromotor
Speed:
10,000Rpm max (with a 1:1 contra-angle)
600Rpm (with a 16:1 contra-angle)
Torque: 10Ncm (with a 16:1 contra-angle)
Part(s) applied: Rotary instrument holder. Tool (file).
Utilisation:
The medical device must not be used above an altitude of 2,000 metres (6,500 feet). The medical device is not restricted by a limited
number of utilisations.
Interactions:
- The device complies
with
electromagnetic interference does not cause an additional risk (presence of radiofrequency emitters, electronic devices, etc. ).
- Interference may occur when used on patients with cardiac pacemakers. This system emits electromagnetic fields, which means there
are some potential risks. The malfunctioning of implantable devices such as cardiac pacemakers and ICDs (implantable cardioverter
defibrillator) is possible:
- Ask patients and users if they have an implanted device before using this product. Explain the circumstances to them
- Weigh the risks and benefits and contact your patient's cardiologist or appropriate qualified healthcare professional prior to
performing the treatment
- Keep this product away from implanted devices
- Make appropriate emergency provisions and take immediate action if patients become ill
- Symptom including a raised heartbeat, irregular pulse, and dizziness may signal problems with a cardiac pacemaker or ICD.
Electrical connection:
- Your device must be
connected
- The electric supply to which the device is connected must comply with the standards in force in your country.
Using the device:
- Do not use the
device
if it
- Turn the device off before
- To unplug the
power
cord, grip the cord plug and hold the wall socket.
- When the device is not to be used for a long period of time, unplug the device from the electric supply.
- Do not move the
device
Do not insert anything inside the motor
The "ENDO micromotor" is supplied Non-Sterile
Use only power adaptor provided (chapter III)
Use for intended purposes only. Failure to observe the operating instructions may result in the patient or user suffering serious
injury. Before using this product, make sure that you have studied and understood the operating instructions.
Do not install where there is a risk of an explosion. The systems are not intended for operation in the presence of flammable
anesthetics or gases.
Do not disassemble or alter the system motor, console, or footswitch.
Connect mains cord to a properly outlet only.
Never touch files when they are still rotating.
Contra-angle should only be attached when the motor has stopped running.
applicable electromagnetic compatibility standards. The user should nevertheless ensure that any potential
to the electric power supply by a certified dental installation technician.
appears
to be damaged or faulty.
unplugging
the power cord.
during use.
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