AAASAB450

Trade name

not provided

00645517886336

00645517LaminationAP

Reference / catalog number

AAASAB450

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

  Failure to use the provided fiberglass strips to reinforce the attachment could lead to failure of the prosthesis. INSUFFICIENT FASTENER LENGTH WILL LEAD TO FAILURE OF THE PROSTHESIS! • MAXIMUM mounting screw protrusion = 18.5mm (.728”) EXCESSIVE FASTENER LENGTH WILL RESULT IN FALSE ASSEMBLY TORQUE READING AND COMPONENT FAILURE! • Never modify the Trulife Socket Attachment Block unless directed to in this installation guide. Any modifications will void the warranty and can lead to failure. • Final application of fastener tightening torque must be done within 2 hours of initial application of blue Loctite 243 thread retaining compound. • DO NOT use high-strength forms of thread retaining compound (example: Red or Green Loctite formulations). • 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 fastener may lead to component failure. • 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 reuse bolts. If you need to reinstall Trulife components for any reason, please call Trulife for new fasteners. • Do not contaminate fasteners with any type of paint, glue, or cement, except for the recommended thread retaining compounds. For all fasteners, ensure a free-running thread fit prior to applying final tightening torque. • 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.