2
1
User and Intended Purpose / Indication for Each
Attachment
1 – 1 User and Intended Purpose
User
:
Qualified Professionals (Surgeon with knowledge and skills required for operating this product).
Intended Purpose
:
These devices are designed to be used with the electric or pneumatic surgical instruments, and the
cutting accessories manufactured by Nakanishi INC. These devices are intended for: cutting, drilling,
removal, and shaping of bones and implants in the fields of Neuro, Spine, Orthopedic, ENT, Oral
Maxillofacial, and Plastic and reconstructive surgery.
Intended patient
population
:
The user shall determine the patient.
1 – 2 Indication for Each Attachment
Attachment
Application
Surgical fields
Cutting
bone
Cutting
implant
Neuro-
surgery
Spine
surgery
Orthopedic
surgery
ENT
surgery
Oral
Maxillofacial
surgery
Plastic and
reconstructive
surgery
Primado Slim Attachment
✔
✔
✔
✔
✔
✔
✔
Slim Handpiece 200
✔
✔
✔
✔
✔
✔
✔
Slim Attachment 300
✔
✔
✔
✔
✔
✔
✔
Primado Standard Attachment
✔
✔
✔
✔
✔
✔
✔
Standard Handpiece 200
✔
✔
✔
✔
✔
✔
✔
Standard Attachment 300
✔
✔
✔
✔
✔
✔
✔
High Speed Handpiece 200
✔
✔
✔
✔
✔
✔
✔
Primado Drill Attachment
✔
✔
✔
✔
✔
✔
✔
Drill Handpiece 200
✔
✔
✔
✔
✔
✔
✔
Primado Super Slim
Attachment
✔
✔
Super Slim Handpiece 200
✔
✔
Perforator Handpiece
✔
✔
Perforator Handpiece 200
✔
✔
Craniotome Handpiece
✔
✔
Craniotome Handpiece 200
✔
✔
Primado Contra Angle
Attachment
✔
✔
✔
Contra Angle Handpiece 200
✔
✔
✔
Bone Saw Attachment 200
✔
✔
✔
✔
✔
✔
Primado Wire Pin Driver
Attachment
✔
✔
✔
✔
Metal Cutting Handpiece 200
✔
✔
✔