Össur ICELOCK 272 MALE PYRAMID TI Instrucciones Para El Uso página 4

ENGLISH
Medical Device
INTENDED USE
The device is intended as a connection component of a prosthetic system
that replaces a missing lower limb.
Suitability of the device for the prosthesis and the patient must be
evaluated by a healthcare professional.
The device must be fitted and adjusted by a healthcare professional.
For more detailed device information, see Table 1.
Indications For Use and Target Patient Population
• Lower limb loss, amputation, or deficiency
• No known contraindications
For weight limit and impact level, see Table 2.
GENERAL SAFETY INSTRUCTIONS
The healthcare professional should inform the patient about everything in
this document that is required for safe use of this device.
Warning: If there is a change or loss in device functionality, or if the device
shows signs of damage or wear hindering its normal functions, the patient
should stop using the device and contact a healthcare professional.
The device is for single patient use.
ASSEMBLY INSTRUCTIONS
Components:
• Stainless Steel Pyramid w/ O-Ring (3).
• Pyramid Cap (2).
• Plastic Washer M8 (1b)
• Pyramid Bolt Long w/ O-Ring (1).
• Silicone Fill for 273 Pyramid (4a).
OR
• Titanium Pyramid w/ Spacer & O-Ring (3).
• Pyramid Cap (2).
• Plastic Washer M8 (1b)
• Pyramid Bolt Long w/ O-Ring (1).
• Silicone Fill for 272 Pyramid (4a).
Use with L-211000 Icelock Clutch 211
Lamination Instructions:
1. Flatten distal end of Plaster Cast (8) to center Delrin Guide (7). Attach
with nails provided or double-sided tape maintaining original pin
alignment.
2. Apply inner PVA bag and tie it around 'neck' on Delrin Guide.
3. Trim bag around string and place Silicone Seal (6) over 'neck' of Delrin
Guide (7), onto PVA bag. Bond Silicone Fill (4a) to Lock Body (4b)
using double-sided tape.
4. Place Lock Body (4b) and connected Silicone Fill (4a) onto Delrin Guide
(7), making sure the Dummy Screw (5) for Clutch Mechanism (9) is
correctly positioned.
5. Place Pyramid (3) onto Lock Body (4b), making sure that O-Ring in
groove on pyramid is in place.
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