E-SOUM-OR Rev M
11
List Of Cautions
CAUTION 1.1
Special Skills Training Requirements
1.
Federal law restricts this device to sale by, or on the order of a licensed healthcare practitioner.
2.
The SonicOne O.R 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 O.R 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 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 O.R 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 protion,
may be necessary for removal of very dense, hard osseous structures of the skull, when using the SonicOne
O.R. accessories.
CAUTION 7.1
All reusable system components like handpiece, probe covers, counter wrench, and T-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.
CAUTION 9.3
Do not immerse ultrasonic console, handpiece, irrigation pump, remote footswitch or electric cables. These
items are not sealed against liquids and damage to equipment will result.
CAUTION 12.1
Use only genuine replacement parts from Misonix. Use of parts furnished by other sources may result in
patient or operator injury or system malfunction and will void any applicable warranty.
CAUTION 12.2
Before using loose packing materials, such as foam pellets, shredded paper or similar, be sure to wrap the
component(s) separately in plastic bags, film or other protective wrapping.
