AAA216-01

Trade name

not provided

00645517856766

00645517AdapterAZ

Reference / catalog number

AAA216-01

GS1

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://trulife.com/

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Y062499LOWER EXTREMITY PROSTHESES - OTHER

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  • Do not connect flange to carbon fabric lamination. Galvanic corrosion of the aluminum component will occur. • Avoid exposing any Trulife Aluminum Adapter to corrosives such as salt water, chlorinated water, ammonia, highly acidic, or highly alkaline agents. In case of exposure, rinse with fresh water and allow to thoroughly dry. • Do not allow moisture to accumulate or dwell inside the adapter. • Insufficient fastener torque will lead to fatigue failure of any modular adapter. • Excessive fastener torque can strip threads. • Torque settings should be checked periodically. A loose set screw may lead to component failure. • Stop use immediately if a set screw needs to be re-tightened more than once. Loosening of set screws may be an early indication of component failure. • Use only bolts, set screws and other fasteners supplied or recommended by Trulife. Use of unapproved fasteners will void the warranty and may lead to component failure. • Final application of fastener tightening torque must be done within 2 hours of initial application of blue Loctite 242 thread retaining compound. • Do not contaminate fasteners with any type of paint or adhesive, except for the recommended thread retaining compounds. For all fasteners, ensure a free-running thread fit prior to applying final tightening torque. • When adjusting alignment or re-assembling components that had been previously assembled with thread retaining compounds, the threads of the fasteners and threaded holes should be cleaned and free of any retaining compound residue to ensure a free-running thread fit. • Never modify any Trulife Aluminum Adapter unless directed to in this installation guide. Any modifications to an adapter will void the warranty and can lead to failure. • Failure to follow the installation and use procedures set forth above may lead to structural failure of the components subjecting the user to a risk of serious personal injury.