E-SOUM-PLUS Rev E
11
List Of Cautions
CAUTION 1.1
Special Skills Training Requirements
Federal law restricts this device to sale by, or on the order of a licensed healthcare practitioner.
The SonicOne CLINIC system is to be used by an appropriately trained and licensed healthcare practitioner.
CAUTION 1.2
This device is considered medical electrical equipment. Medical electrical equipment needs special
precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service
according to the EMC information provided in this operator’s manual.
CAUTION 1.3
Portable and mobile RF communication equipment can affect medical electrical equipment. If RF
equipment is in use monitor the SonicOne Clinic for proper function during procedure.
CAUTION 1.4
The use of accessories, transducers and cables other than those specified may result in increased
emissions or decreased immunity of the device. Use only Misonix branded equipment and accessories.
CAUTION 1.5
The console should not be used adjacent to or stacked with other electrical equipment. If adjacent or
stacked use is necessary, the console should be observed to verify normal operation in the
configuration in which it will be used.
CAUTION 1.6
Be certain to clear debris from all hollow passages of the probe and handpiece by manual brushing.
Failure to do so may hinder disinfection of the units or sterilization of units during autoclaving.
CAUTION 1.7
Allow reusable, autoclavable items to gradually return to room temperature after steam sterilization
and prior to usage.
CAUTION 3.1
The SonicOne Clinic system and its accessories may emit harmful acoustic pressure if exposure
exceeds recommended limits.
CAUTION 4.1
Ultrasonic energy is inhibited if excessive physical force is applied to the ultrasonic tip; use only enough
force to guide the tip to the surgical site and to advance it through the tissue. Do not force the tip; allow
the ultrasonic action to do the work.
CAUTION 4.2
Insufficient irrigation and high tip pressure (loading) under extended exposure, e.g. in tight cavities, are to
be avoided in SonicOne CLINIC hard tissue removal. It is recommended to withdraw and re-insert the
ultrasonic tip repeatedly to re-establish adequate cooling and lubrication.
CAUTION 4.3
Additional external irrigation, e.g. by administering sterile saline with a syringe over the distal tip portion,
may be necessary for removal of very dense, hard osseous structures of the skull, when using the
SonicOne CLINIC accessories.
CAUTION 7.1
All reusable system components like handpiece, probe covers, counter wrench, and 7/16
th
probe wrench
are supplied industrially cleaned, but NON-STERILE. All items intended for use in the sterile field must be
cleaned and sterilized as per the indicated instructions before first Clinical use and before every
subsequent Clinical use.
CAUTION 7.2
All items intended for use in the sterile field must be cleaned and sterilized as per indicated instructions
before each Clinical use.
CAUTION 7.3
The disposable items are intended for one procedure only (single use). Do not attempt to reuse or re-sterilize.
CAUTION 7.4
Do not place the soft silicone tube behind or in front of the rollers (latch removed in illustrations)
CAUTION 7.5
Do not pinch the soft silicone tube when the latch is locked.
CAUTION 7.6
Do not pinch barb fittings when closing the latch.
CAUTION 7.7
Prime the irrigation tubing prior to use. At all times ensure that the irrigant flows towards the handpiece
when footswitch is depressed. If no irrigant is flowing, cease use until flow is restored.
CAUTION 7.8
The system check should always be done in advance of preparing patient for surgery to minimize risk to
patient in case of system malfunction.
CAUTION 8.1
Ensure all connections and mating surfaces of handpiece, extension and ultrasonic tip are clean and dry
before assembly.
CAUTION 9.1
Do not use ultrasonic cleaners to clean the handpiece as this method could damage handpiece.
CAUTION 9.2
Be certain to clear debris from all internal passages by brushing. Failure to do so may hinder sterilization of
units during autoclaving.
