2
Intended Use
The Primado 2 is an AC-electrically powered total surgical system that is intended for cutting, drilling, sawing, and otherwise manipulating
soft tissue, hard tissue, bone, bone cement, prosthesis, implant, and other bone related tissue in a variety of surgical procedures, including
but not limited to Cranial(Craniofacial/Maxillofacial), ENT, Endoscopic/Arthroscopic, Neuro, Orthopedic, Spinal, and General surgical
procedures.
DANGER
ƔDo not use this system in a room where there is danger of explosion or in the vicinity of flammable substances. It is especially important
not to use this system on a patient to whom a flammable anesthetic agent (dinitrogen monoxide) has been administered.
ƔShould a short circuit occur inside this product, an electric shock or fire may result if the product is not connected to properly grounded
electric supply.
ƔNever disassemble or modify the product. Personal injury, electric shock or fire may result.
WARNING
ƔWhen operating the product always consider the safety of the patient.
ƔThis is a medical system; do not allow anybody to use it other than surgeons who are familiar with the procedures. Use this system in
accordance with its intended use and proper method of use.
ƔThis product may be affected when used in rooms with electromagnetic interference and portable or mobile RF communication
equipments. Do not use this product around any equipment that generates electromagnetic waves such as an ultrasonic generator and
electrical scalpel. In case equipment generating electromagnetic waves are used around this product, turn off the Control Unit.
ƔDo not directly spray detergent/liquid on the LCD Touch Panel of the Control Unit when cleaning the Control Unit. Breakdown of the
Control Unit may be caused due to the short circuit.
ƔExcept for the Foot Control, this system is not designed to be water-proof. Handle the Control Unit and Motor with care so that they will
not be exposed to water or sterile water (saline solution). An electric shock may result due to a short circuit.
CAUTION
ƔU.S. Federal law restricts this device to sale by or on the order of a licensed physician.
ƔThe applicable Attachment/Handpiece for cutting implants is Metal Cutting Handpiece 200.
ƔBe sure to read this manual prior to use to become completely familiar with the function of each part.
ƔConnect the product to an electrical outlet for medical use or a properly grounded outlet.
ƔThe
Motor
and the Attachment/Handpiece (separately sold) are not sterilized before delivery. So, be sure to sterilize them prior to use.
ƔOperate and inspect the Attachment/Handpiece prior to use. Even if only a slightly abnormal condition is detected, immediately stop using
it and contact your dealer.
ƔEven if only a slightly abnormal condition such as vibration, noise, or heat generation is detected during operation or prior to use, stop
using it and contact your dealer.
ƔDo not subject this unit to strong impacts, such as dropping it on the floor. Personal injury, abnormal heating and fire may result caused
by the internal damage.
ƔDo not bend or kink the Irrigation Tube while the Irrigation Pump is operating. Damage or disconnection of the Irrigation Tube may result.
ƔTurn off the power when mounting or removing the Motor and Attachment/Handpiece. Mounting or removing with the power on may
cause personal injury due to an unexpected rotation.
ƔWhen the Control Unit and Foot Control are stained with blood, turn off the power and wipe the stains off using a lint-free cloth moistened
with neutral detergent for medical use. Then, remove the detergent using a lint-free cloth moistened with distilled, deionized or
demineralized water.
ƔDo not lubricate the Motor. It may result in an abnormal heating and failure.
ƔDo not disconnect the Motor Cord from the Motor. It may cause failure.
ƔDo not clean the product with solvents such as thinner or benzene solution. Discoloration or deformation may result.
ƔDispose of the Irrigation Tube after use as medical waste.
ƔThis product needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information.
ƔThe use of accessories, Attachments/Handpieces and cords other than those specified, with the exception of accessories, Attachments/
Handpieces and cords sold by the manufacturer of this product as replacement parts for internal components, may result in increased
EMISSIONS or decreased IMMUNITY of this product.
ƔThis product should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, observe
this product and other equipments in order to verify a normal operation prior to use.
ƔRegarding the operation time of the Motor, follow specification table in step “11. Specifications”. Continuous use of the Motor for a
prolonged period might cause overheating, which can cause an accident.
ƔThe temperature of the Motor and Control Unit mounting parts may reach up to 60°C depending on the environment.
Before use, read carefully the Operation Manual of the Motor and the Attachments/Handpieces.
