User Guide

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SSK615, SSK615-THR

Select Stance Flexion Knee

Instructions and User Guide

27663-001 REV L 2023-02-17

Trulife www.trulife.com Page 1 of 4

INTRODUCTION

Trulife’s Select Stance Flexion Knee offers transfemoral amputees dynamic features in a lightweight package. Designed for the

moderate to active amputee (K3 or K4 activity levels), Trulife’s polycentric pneumatic 5-bar offers significant advantages for the

amputee including: pneumatic swing phase control, adjustable stance flexion, spring knee extension assist, and adjustable flexion

control and extension control. The fitting process is simplified with a built in distal tube adapter.

Product Code Description Weight Limit Proximal Attachment

SSK615 Select Stance Flexion Knee 136 kg (300 lb) Pyramid

SSK615-THR Select Stance Flexion Knee with Threaded Adapter 136 kg (300 lb) Threaded

INDICATIONS

Above knee amputations with a medium to high impact level, K3-K4.

LIMITATIONS

• The SSK615 Select Flexion Knee requires a clearance of 30mm • 1.18" from knee center to mounting surface of the knee unit.

The knee reaches full flexion at 145°.

• The SSK615-THR Threaded Select Flexion Knee requires a clearance of 23mm • 0.91" from knee center to mounting surface of

the knee unit. The knee reaches full flexion at 145°.

INSTALLATION AND USE

Recommended installation and use procedures must be followed for maximum safety and service life.

Never modify the Select Stance Flexion Knee. It will void the warranty and can cause failure. Use only bolts and screws

supplied by Trulife. Use of unapproved fasteners will void the warranty and can cause failure.

Do not expose knee to water, functionality will be compromised and can cause failure.

Proximal Socket Attachment

• The SSK615 comes with an attached proximal standard male pyramid.

• The SSK615-THR has a threaded proximal attachment point which is designed to be used either with the AAA212 4-Hole

Rotatable Base, or the AAASS237 3-Prong Threaded Lamination Anchor.

Pylon Attachment

1. Cut the pylon to the appropriate length. The cut must be smooth and level.

2. Remove any burrs from the end of the pylon using sand paper.

3. Fully insert the pylon into the distal knee unit.

4. Apply Loctite® 242 removable thread locking compound to the clamp bolt. Loctite® requires several hours to cure completely.

5. Using a torque wrench, tighten the Clamp Bolt (Figure 1) to 12 Nm (9 ft-lbs or 108 in-lbs) using a 5mm hex wrench.

Never permit a patient to walk on a partially inserted or shimmed pylon. This will void the warranty and can contribute to

component failure or injury.

Knee Alignment

When assembling the prosthesis using the Select Stance Flexion Knee, the bench alignment can be set using the following

procedure.

Summary of content (4 pages)

PAGE 1
SSK615, SSK615-THR Select Stance Flexion Knee Instructions and User Guide 27663-001 REV L 2023-02-17 INTRODUCTION Trulife’s Select Stance Flexion Knee offers transfemoral amputees dynamic features in a lightweight package.
PAGE 2
SSK615, SSK615-THR Select Stance Flexion Knee Instructions and User Guide 27663-001 REV L 2023-02-17 1. 2. Perform a Medial/Lateral (coronal plane) alignment. Set the alignment so the load line of body weight passes through the center of the knee and reaches the center of the heel. Perform an Anterior/Posterior (sagittal plane) alignment. Set the alignment so the load line of body weight passes 5mm • 0.20” forward from the anterior superior axis and the midpoint between heel and toe-break.
PAGE 3
SSK615, SSK615-THR Select Stance Flexion Knee Instructions and User Guide 27663-001 REV L 2023-02-17 3. • Rotate the adjustment screw clockwise to decrease the overall sensitivity of the joint (increasing stability). Re-tighten the Stance Phase Sensitivity Lock Screw. Stance Flexion Resistance Adjustment 1. Locate the two Stance Flexion Resistance Adjustment Lock Screws on the anterior of the knee (Figure 1). Using a 2mm hex wrench, loosen the two lock screws. 2.
PAGE 4
SSK615, SSK615-THR Select Stance Flexion Knee Instructions and User Guide 27663-001 REV L 2023-02-17 LEGAL INFORMATION The use of this class 1 medical device is subject to the respective national laws of the country of use and may vary accordingly. The user of this device should report any serious incident to Trulife and the competent authority of the country of use. Trulife 3225 Woburn St. Suite 160 Bellingham, WA 98226 USA Phone (+1) 360 697 5656 Email supportop@trulife.