Essential Requirements; During Use; Scope Of Delivery - Nouvag MD11 Mode D'emploi

3.4

Essential requirements

The MD 11 may only be operated by
qualified and trained personnel.
The use of third-party products is the
responsibility of the operator.
Functionality and patient safety cannot be
guaranteed with third-party accessories.
Repairs may only be performed by
authorized NOUVAG service technicians.
3.5

During use

The device is not sterile on delivery. All
sterilizable parts must be sterilized before
use (see Chapter 8 Cleaning, disinfection
and sterilization).
Handpieces and contra angles may only
be attached when the electronic motor is
not running.
To prevent injury, never touch drill bits or
burrs while they are still running.
At operation at a patient, make sure to produce as less as possible friction heat. By excessive thermal
influence on the tissue, the tissue easily gets necrotized. The heat generation is directly proportional to
the speed delivery of the instrument and the contact pressure delivered by the instrument.
4

Scope of delivery

Art. No. Description
3335 MD 11 control unit-----------------------------------------------------------------------------------------------------1 unit
1866nou Vario pedal; IPX8; electronic ---------------------------------------------------------------------------------------1 unit
2097 Electronic motor 21 incl. 2 m motor cable ----------------------------------------------------------------------1 unit
1706 Tube set, sterile, 2 m, single-use ----------------------------------------------------------------------------------1 unit
1873 Clip set (10 pieces) for tube set attachment at motor cable------------------------------------------------1 unit
1881 Clip set (3 pieces) for tube set attachment at handpieces and contra angles--------------------------1 unit
1707 Irrigation fluid; 0.9% sodium chloride/water solution, 1 liter ----------------------------------------------1 unit
1770 Stand for irrigation fluid---------------------------------------------------------------------------------------------1 unit
1170 Handpiece cradle------------------------------------------------------------------------------------------------------1 unit
1974 Spray nozzle for Nou-Clean spray; for care of electronic motor ------------------------------------------1 unit
1958 Spray nozzle for Nou-Clean spray; for care of instruments ------------------------------------------------1 unit
31665 User Manual MD 11 on CD-ROM ----------------------------------------------------------------------------------1 unit
In line with regulations pertaining to hazardous materials, the following items are not delivered with
the control unit and must be ordered separately:
1984 Nou-Clean maintenance and care spray ------------------------------------------------------------------------ 1 unit
4
Improper use or repair of the device and failure to
observe these instructions relieve us from any
obligation arising from warranty provisions or other
claims.
Prior to using the device, before startup, and before
operation, the user must always ensure that the
device and accessories are in good working order
and are clean, sterile and operational.
Use Nou-Clean spray for maintenance and care of
the motor, handpieces and contra angles. Using
other care products can result in malfunctions
and/or cause the warranty to be revoked.
At the choosing of the instrument the operator has
to make sure it's biocompatible, according to
EN ISO 10993.
Never operate the clamping mechanism of the
handpieces or contra angles while the system is
running. This could result in instrument damage.
Do not use device in the vicinity of flammable
mixtures!
MD 11 Operating Instructions, Art. No. 31665, V10/14
MD 11
Quantity