NSK Primado2 - User and Intended Purpose; Attachment Indications for Use

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
✔ ✔ ✔