Medtronic 6475000-SL Instructions for Use

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IMPORTANT INFORMATION ON THE LEGEND® POWER ADAPTER

INFORMATIONS IMPORTANTES SUR L’ADAPTATEUR SECTEUR LEGEND®

INFORMACIÓN IMPORTANTE SOBRE EL ADAPTADOR DE CORRIENTE LEGEND®

WICHTIGE INFORMATIONEN ÜBER DEN LEGEND® POWER ADAPTER

INFORMAZIONI IMPORTANTI SULL’ADATTATORE DI ALIMENTAZIONE LEGEND®

BELANGRIJKE INFORMATIE OVER DE LEGEND®-STROOMADAPTER

VIGTIGE OPLYSNINGER OM LEGEND® STRØMADAPTER

VIKTIG INFORMATION OM LEGEND®-STRÖMADAPTER
VIKTIG INFORMASJON OM LEGEND® STRØMADAPTER

TÄRKEITÄ TIETOJA LEGEND®-TEHOSOVITTIMESTA

ΣΗΜΑΝΤΙΚΕΣ ΠΛΗΡΟΦΟΡΙΕΣ ΓΙΑ ΤΟ ΤΡΟΦΟΔΟΤΙΚΟ LEGEND® POWER ADAPTER

INFORMAÇÃO IMPORTANTE SOBRE O ADAPTADOR DE ALIMENTAÇÃO LEGEND®

DŮLEŽITÉ INFORMACE O PŘÍSTROJI LEGEND® POWER ADAPTER

TÄHTIS TEAVE TOITEADAPTERI LEGEND® KOHTA

FONTOS TUDNIVALÓK A LEGEND® POWER ADAPTERRŐL

SVARĪGA INFORMĀCIJA PAR LEGEND® STRĀVAS ADAPTERU

SVARBI INFORMACIJA APIE LEGEND® MAITINIMO ADAPTERĮ

WAŻNE INFORMACJE DOTYCZĄCE ADAPTERA LEGEND®

DÔLEŽITÉ INFORMÁCIE O NAPÁJACOM ADAPTÉRI LEGEND®

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AUSTRALIAN SPONSOR:

Medtronic Australasia Pty Ltd Medtronic Sofamor Danek USA, Inc. Medtronic B.V.

2010-11

97 Waterloo Rd 1800 Pyramid Place Earl Bakkenstraat 10
North Ryde, NSW 2113 Memphis, TN 38132 6422 PJ Heerlen
Australia Telephone [phone] (In U.S.A.) The Netherlands
901 396 3133 (Outside U.S.A.) Tel: + 31 45 566 80 00
Fax [phone]

ENGLISH

IMPORTANT INFORMATION ON THE LEGEND® POWER ADAPTER

DESCRIPTION

The LEGEND® Power Adapter is a stainless steel adapter that can be used with the MIDAS REX® LEGEND® System to provide power t
MEDTRONIC rotating surgical cutting tools. The LEGEND® Power Adapter provides a 20:1 gear ratio reduction when used with the MIDAS REX
LEGEND® System. Do not use the LEGEND® Power Adapter with any power system other than the MIDAS REX® LEGEND® System (LEGEND
EHS and LEGEND EHS Stylus™). Also, do not use the LEGEND® Power Adapter with any surgical cutting tools other than MEDTRONIC surgic
cutting tools unless specifically labeled to do so.

No warranties, expressed or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specificall
excluded. See the MDT Catalog or price list for further information about warranties and limitations of liability.

INDICATIONS

The LEGEND® Power Adapter is intended to be used with the MIDAS REX® LEGEND® System. When the LEGEND® Power Adapter is attache
to the MIDAS REX® LEGEND® System, the MIDAS REX® LEGEND® System motors provide power to operate removable rotating surgica
cutting tools and their accessories intended for neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT
orthopedic, and general surgical applications including maxillofacial, craniofacial, and sternotomy surgeries.

POTENTIAL ADVERSE EVENTS

Breakage, slippage, misuse, or mishandling of components such as on sharp edges may cause injury to the patient or operative personne
Improper maintenance, handling, or poor cleaning procedures can render the adapter unsuitable for its intended purpose or even dangerou
to the patient or surgical staff.

Proper patient selection and operative care are critical to the success of the device and avoidance of injury during surgery. Read and follo
all other product information supplied by the manufacturer of the components.

In addition, any breakage of an instrument in this situation could be extremely hazardous. The physical characteristics required for man
instruments does not permit them to be manufactured from implantable materials, and if any broken fragments of instruments remain i
the body of a patient, they could cause allergic or infectious consequences.

WARNINGS AND PRECAUTIONS

The LEGEND® Power Adapter should only be used with the MIDAS REX® LEGEND® System and MEDTRONIC surgical cutting devices. Use
of devices other than with the MIDAS REX® LEGEND® System and MEDTRONIC surgical cutting devices may cause injury to the patient,
operator, and/or operating room staff.

The LEGEND® Power Adapter is designed for use by medical professionals familiar with powered surgical instrumentation. The surgeon is
responsible for learning the proper techniques in the use of this system, as inappropriate use may potentially be harmful.

Do not use the adapter with the MIDAS REX® Classic Motor System, the MIDAS REX® III Motor System, or the MEDNEXT® Bone Dissecting
System and their associated components.

Do not use excessive pressure such as bending or prying on the adapter. This may cause the adapter to bend or break and cause injury to
the patient, operator, and/or operating room staff.

Do not use the adapter if any part of the adapter appears to be bent, loose, missing, or damaged. If a LEGEND® Power Adapter requires
servicing or refurbishing, return attachment to MEDTRONIC.

Do not force or modify any surgical cutting device to fit the LEGEND® Power Adapter.

The methods of use of instruments are to be determined by the user’s experience and training in surgical procedures.

Do not use solvents or harsh detergents to clean any portion of the system.

Eye protection should be worn at all times.

Do not use this adapter for any action for which it was not intended such as hammering, prying, or lifting.

This adapter should be treated as any precision instrument and should be carefully placed on trays, cleaned after each use, and stored in
a dry environment.

To avoid injury, the adapter should be carefully examined prior to use for functionality or damage. A damaged adapter should not be used.
Additional back-up instruments should be available in case of an unexpected need.

MEDTRONIC does not and cannot warrant the use of this instrument nor any of the component parts upon which repairs have been made
or attempted except as performed by MEDTRONIC or an authorized MEDTRONIC repair representative.

Heavy side loads and/or long operating periods may cause overheating of the adapter to the point where the adapter is uncomfortable to
hold. Never place an overheated attachment on the patient or patient draping during surgery, mitigate the overheating by discontinuing
use and rest that adapter by using intermittently, or wrap the attachment interface with a moist sterile towel, and if the adapter is passed
off, the receiver of the adapter must handle the adapter cautiously.

DO NOT IMPLANT THE LEGEND® Power Adapter

Correct care, handling, and maintenance procedures must be followed to ensure proper function and reasonable product life. Prior to use,
test and inspect for proper function of all components individually as well as systemically. If any component shows visible signs of damage
or fails to operate properly, discontinue its use immediately. Note that components which have experienced extensive use or excessive
force may be susceptible to failure. This adapter should only be used for its intended purpose.

For additional warnings and precautions, refer to the MIDAS REX® LEGEND® System operating guidelines.
PHYSICIAN NOTE: Although the physician is the learned intermediary between the company and the patient, the important medical

information given in this document should be conveyed to the patient.

!USA

FOR US AUDIENCES ONLY

CAUTION: FEDERAL LAW (USA) RESTRICTS THESE DEVICES TO SALE BY OR ON THE ORDER OF A PHYSICIAN.

PACKAGING

Packages for each of the components should be intact upon receipt. If a loaner or consignment system is used, all sets should be carefully
checked for completeness and all components including instruments should be carefully checked to ensure that there is no damage prior
to use. Damaged packages or products should not be used, and should be returned to MEDTRONIC.

CLEANING AND DECONTAMINATION

Unless just removed from an unopened sterile MEDTRONIC package, all instruments and implants must be unpackaged, disassembled (if
applicable), and cleaned before sterilization, introduction into a sterile surgical field, or if applicable, return of the product to MEDTRONIC.
Remove all packaging materials prior to disassembly (if applicable) and cleaning. Cleaning instructions and associated disassembly instructions
(if applicable) can be found at HYPERLINK “http://manuals.medtronic.com” http://manuals.medtronic.com.

Note: certain cleaning solutions such as those containing formalin, glutaraldehyde, bleach and/or other alkaline cleaners may damage some
devices, particularly instruments. These solutions should not be used unless instructed by the Instrument Care, Cleaning, and Sterilization
Quick Reference Guide part number 0381424. Also, many instruments require disassembly before cleaning.

All products should be treated with care. Improper use or handling may lead to damage and/or possible improper functioning of the device.

STERILIZATION

Unless marked sterile and clearly labeled as such in an unopened sterile package provided by the company, all implants and instruments
used in surgery must be sterilized by the hospital prior to use. Remove all packaging materials prior to sterilization. Only sterile products
should be placed in the operative field. Unless specified elsewhere, these products are recommended to be steam sterilized by the hospital
using one of the sets of process parameters below: