E-SOUM-PLUS Rev E
10
WARNING 6.1
Immediately suspend operation if Electrical Fault appears on display and/or an Electrical Fault audible
indicator sounds. Remove ultrasonic tip from surgical site. Turn Mains Power OFF. Do not touch any metallic
parts of handpiece, extension, ultrasonic tip or generator while fault is indicated.
WARNING 7.1
Improper connection of the handpiece cable may present a shock hazard. Confirm that handpiece
connector is dry prior to plugging it in.
WARNING 7.2
Do not operate pump with pump cover in raised position. Rollers might pinch loose clothing or fingers.
Personal injuries may result. Cooling of the ultrasonic tip and irrigation at the treatment site will be inhibited.
WARNING 7.3
Tip and irrigation temperatures may exceed the tissue necrosis point with SonicOne CLINIC accessories for
hard tissue removal if insufficient irrigation flow rates are used. Always set the irrigation flowrate for hard
tissue removal to a setting no less than the comparable vibration setting. For example, if the vibration setting
is a 7, a minimum flow setting of 70% should be used.
WARNING 7.4 Heat is being generated at the tip/tissue interface. A continuous, lateral sweeping motion is recommended
for general bone/tissue removal in order to minimize contact duration with the ultrasonic tip and minimize
the temperature increase.
WARNING 8.1
Remove probe cover, ultrasonic tip and extension from the handpiece prior to cleaning and/or sterilization;
otherwise proper cleaning/sterilization may be inhibited.
WARNING 9.1
Single-use items should be discarded following each surgical procedure according to hospital protocol for
disposal of bio contaminated wastes. Do not attempt to reuse or re-sterilize any single-use items
Dispose ultrasonic tips in a sharps container.
WARNING 9.2
All reusable handpiece parts and accessories must be properly decontaminated, cleaned and sterilized
before each use as per instructions contained in this manual. Failure to do so may lead to infections, which can
ultimately cause patient death.
WARNING 9.3
Misonix Inc. has validated all cleaning and sterilization cycles given in this manual. It is highly
recommended that the procedures given in this manual for cleaning and sterilizing the SonicOne
CLINIC system and related accessories be followed. It is the responsibility of the user of this device or
any accessories used with it to validate procedures for cleaning and/or sterilization if they differ from
the procedures as outlined in this manual.
WARNING 9.4
The disposable items are intended for one procedure only (single use). Do not attempt to reuse or
re-sterilize.
WARNING 10.1 If a Mains Power fuse fails after replacement when the unit is reactivated, discontinue use of the device and
contact an authorized Misonix representative.
WARNING 10.2 Portable and mobile RF communication equipment (including peripherals such as antennas) should be no
closer than 30 cm (12 inches) to any part of the console, including the cables supplied with the console
Otherwise degradation of the performance of this equipment could result.
WARNING 10.3 The use of accessories, transducers and cables other than those specified or provided by Misonix may
result in increased electromagnetic emissions or decreased immunity of the device and may result in
improper operation. Use only Misonix branded equipment and accessories.
WARNING 10.4 Use of this equipment adjacent to or stacked with other equipment should be avoided because it could
result in improper operation. If such use is necessary, this equipment and the other equipment should be
observed to verify that they are operating normally.
WARNING 12.1 Connecting the console to a power outlet with inadequate voltage or frequency may cause the unit to
malfunction or to create a shock or fire hazard. Confirm that the voltage selector switch in the console rear
is set to the local voltage setting and ensure that the correct fuses are being used. Refer to
section 12 on
fuse replacement.
WARNING 12.2 No Modifications of this equipment is allowed except as noted for cleaning and sterilization. The user should
return to Misonix or an authorized service center for servicing.
