NSK Primado 2 Manual de usuario
Total Surgical System
Motor
OM-SE0029E 001
1
Read these precautions carefully and use only as intended or instructed.
Safety instructions are intended to avoid potential hazards that could result in personal injury or damage to the device. Safety instructions are classified as
follows in accordance with the seriousness of the risk.
This product is the Motor used with our surgical control unit Primado2.
Prior to use, read this Operation Manual carefully and understand operating precautions, operating methods and maintenance guidelines so that you can use it
for many years to come through a correct use. Keep this Operation Manual within easy reach.
Precautions for handling and operation
Class
Degree of Risk
DANGER
Hazard that could result in personal death or serious injury if the safety instructions are not correctly
followed.
WARNING Hazard that could result in serious injury or damage to the device if the safety instructions are not correctly
followed.
CAUTION
Hazard that could result in light or moderate injury or damage to the device if the safety instructions are
not correctly followed.
NOTICE General product specification information highlighted to avoid product malfunction and performance
reduction.
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
Do 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.
Never disassemble or modify the product. Personal injury, electric shock or fire may result.
WARNING
When operating the product always consider the safety of the patient.
This 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.
This 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.
3
CAUTION
U.S. Federal law restricts this device to sale by or on the order of a licensed physician.
The applicable Attachment/Handpiece for cutting implants is Metal Cutting Handpiece 200.
Be sure to read this manual prior to use to become completely familiar with the function of each part.
The Motor (separately sold) is not sterilized before delivery. Therefore, be sure to sterilize it prior to use.
Be sure to operate the Attachment/Handpiece connected to Motor and Control Unit prior to use. Even if only a slightly abnormal condition such as vibration,
abnormal sound, and heat generation is detected, stop use and contact your dealer.
Do not subject this product to strong impacts such as dropping it on the floor. Personal injury, abnormal heating and fire may result caused by the internal
damage.
Do not disconnect the Motor Cord from the Motor. It may cause failure.
Do not clean the product with solvents such as thinner or benzine solution. Discoloration or deformation may result.
Regarding the operation time of the Motor, follow the specification table in Step “7. Specifications”. Continuous use of the Motor for a prolonged period
might cause overheating, which can cause an accident.
The temperature of the Motor and Control Unit mounting parts may reach up to 60˚C depending on the environment.
NOTICE
The user shall be responsible for maintenance and operation.
4
1-1 Motor
P200-HMH, P200-SMH, P200-BMH
P200-HMH-HS, P200-SMH-HS, P200-BMH-HS (Motor with Hand Control)
1) Hand Switch* 2) Adjustable Lever*
3) Safety Lock* 4) Motor Cord Plug * Motor with Hand Control only.
2)
1) 3)
ON
OFF 4)
1Part Names
5
1-2 Wire Pin Driver
P200-WPD
1) Trigger (Upper) (A) 2) Safety Lock 3) Trigger (Lower) (B)
4) Mounting/Removal Button 5) Motor Cord Plug
2)
3)
1) 4) 5)
6
2-1 Connection to the Control Unit
By matching the mark on the Motor Cord Plug and the mark on the Motor Connector (A or B) at the
front of the Control Unit, plug the Motor into the Connector all the way.
2How to Connect Each Component
* To disconnect the Motor, hold the Motor Cord Plug and pull it out with a straight movement.
Fig. 1
Refer to the Operation Manuals of Primado2 and Attachments/Handpieces.
CAUTION
There are two Motor Connectors. By connecting two Motors to the two connectors,
you can select the one you want to use by the Motor Select Button of the Control
Unit. (However, both Motors cannot be operated simultaneously.) The selected
Motor can be confirmed in the Main Panel of the Control Unit. Refer to the Operation
Manual of the Control Unit for detail.
CAUTION
Mark
Mark
Motor Cord Plug
7
Whenever you use two Motor Connectors alternately, be sure to confirm which Motor is under operation.
Connect or disconnect the Motor Cord only after turning OFF the Control Unit.
Do not connect the Motor to Control Units other than Primado2. Otherwise, it could deform the Motor Connector and cause failure.
If the Motor Cord cannot be connected to the Control Unit easily, do not insist. Deformation or cracks might occur. A foreign substance
might be obstructing the connection or the connection portion might be deformed. Contact your dealer.
Whenever connecting/disconnecting the Motor with Hand Control and Wire Pin Driver, be sure to turn OFF the Control Unit.
When connecting/disconnecting the Motor, do not rotate the Motor Cord Plug. Otherwise, the inside pins might become damaged,
leading to failure.
Do not connect/disconnect the Motor Cord with wet hands; otherwise, an electric shock might occur.
CAUTION
8
2-2 Mounting of the Attachment/Handpiece
P200-HMH and P200-HMH-HS Attachments/Handpieces
<Mounting>
1) Push the Attachment/Handpiece into the Motor straight.
2) Rotate the Attachment/Handpiece rightward or leftward so that the Alignment Pin of the Motor
(Fig. 2) matches the hole of the Attachment/Handpiece with a clicking sound to connect firmly.
<Removing>
Pull out the Attachment/Handpiece from the Motor straight. Fig. 2
Attachment /
Handpiece
Motor
Alignment Hole Alignment Pin
Whenever mounting/removing the Attachment/Handpiece, be sure to switch OFF the Safety Lock of the Wire Pin Driver/Motor with Hand
Control.
Prior to mounting/removing the Attachment/Handpiece, remove the Bur or Blade. Otherwise, injury might occur.
After mounting the Attachment/Handpiece, confirm that the Attachment/Handpiece and Motor are connected properly.
CAUTION
9
P200-SMH and P200-SMH-HS Attachments/Handpieces
<Mounting>
1) Push the Attachment/Handpiece into the Motor straight.
2) Align the ' ' Symbol of the Attachment/Handpiece and ' ' Symbol of the
Motor (Fig. 3), then push the Attachment/Handpiece in until it clicks to connect firmly.
<Removing>
Pull out the Attachment/Handpiece from the Motor straight.
P200-BMH and P200-BMH-HS Attachments/Handpieces
<Mounting>
1) Push the Attachment/Handpiece into the Motor straight.
2) Rotate the Attachment/Handpiece rightward or leftward so that the Alignment Pin of the Motor
(Fig. 4) matches the hole of the Attachment/Handpiece with a clicking sound to connect firmly.
3) Tighten the Removal Ring of the Attachment/Handpiece manually to fix it firmly.
<Removing>
Loosen the Removal Ring and pull out the Attachment/Handpiece from the Motor straight.
Fig. 3
Fig. 4
Attachment /
Handpiece
Motor
Symbol
Symbol
CLOSE
OPEN
Attachment / Handpiece
Motor
Alignment Hole Alignment Pin
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