Bledsoe Thruster RLF User guide

Bledsoe Thruster RLF
Application Instructions CP020218 Rev D 01/07
MUSCLE-POWERED, FUNCTIONAL KNEE BRACE FOR OSTEOARTHRITIS
FOR PRODUCT INFORMATION OR QUESTIONS PERTAINING TO SALES OR SERVICE,
PLEASE CONTACT THE SALES REPRESENTATIVE IN YOUR AREA OR BLEDSOE BRACE SYSTEMS DIRECTLY.
This device is offered for sale by or on the order of a physician or other qualified medical professional. This device is not intended for reuse on a second patient.
Indications: Thruster RLF MA is indicated for Medial Unicompartmental Gonarthrosis. Thruster RLF LA is indicated for Lateral Unicompartmental Gonarthrosis. Each
brace may help to relieve symptoms of pain and inflammation. These braces are designed to aid in delaying osteotomy or total joint procedures, to increase daily walking
time while increasing activities, and to aid in slowing the progression of the condition. These braces are also indicated for post-operative or post-injury application following
collateral ligament injury or reconstruction (when worn on the opposite side from the injury) to relieve stress on these healing structures and post-meniscal repairs.
Contraindications: Thruster RLF MA is contraindicated for Lateral Unicompartmental Osteoarthritis. Thruster RLF LA is contraindicated for Medial Unicompartmental
Osteoarthritis. Both are contraindicated for tri- or bi-compartmental osteoarthritis, or for knees with injury or chronic stretch of the collateral ligament on the same side of the
leg as the brace placement.
WARNING: Do not leave this device in the trunk of a car on a hot day or in any other place where the temperature may exceed 150° F (65° C) for any extended period
of time. If any additional pain or symptoms occur while using this device, discontinue use and seek medical attention.
Warranty: This device is warranted to be free from defects in material and workmanship for a period of 90 days for wraps, pads, straps and normal wear components,
12 months on all other parts and 3 years against hinge breakage. These warranties apply to devices that have not been modified or subjected to misuse, abuse or neglect.
This device is expressly subject to Bedsoe’s Product Line Warranty. Copies of this limited warranty can be obtained from your medical professional, via the Internet at
www.bledsoebrace.com or by calling [phone].
ORTHOMEDICO (EUROPEAN BLEDSOE SALES AGENT)
([phone] www.orthomedico.be
MANUFACTURED BY:
Bledsoe Brace Systems™
2601 Pinewood Drive, Grand Prairie, Texas 75051 USA
CUSTOMER CARE 1-888-BLEDSOE ( 253-3763)
LOCAL PHONE [phone] LOCAL FAX [phone]
INTERNATIONAL FAX [phone]
www.bledsoebrace.com
EUROPEAN AUTHORIZED REPRESENTATIVE
EMERGO EUROPE
Molenstraat 15
2513 BH, The Hague
The Netherlands
Tel: [phone]
Fax: [phone]
Council Directive 93/42/EEC
of 14 June 1993 concerning
Medical devices

1. Unfasten Buckles
Unfasten all of the buckle ends from the shell
by pushing the gray button on each buckle. If
this is the first time the brace is applied, turn
the force knob to its lowest force setting.
Bledsoe Thruster RLF Application Instructions
Page 2 of 4 CP020218 Rev D 01/07
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3. Upper Calf Strap
Apply the upper calf strap by wrapping it up and
over the calf muscle and around to the front of
shell to engage the buckle. Adjust the length of
the strap using the hook and pile fastener on
the buckle end of strap. This should be snug,
but not tight enough to cause discomfort or
affect circulation. Use the buckle to release the
strap when putting the brace on and taking it
off. Velcro ends are there for adjustment only.
Leaving this adjustment loose will take away
from the brace force. Make sure that the strap
pad is positioned just behind the edge of the
shell on the side opposite from the hinge.
2. Apply the Brace
If desired, apply the undersleeve prior to fitting
the brace. Apply the brace with the patient in
a seated position and the leg bent at 80°- 90°.
For a Medial (MA) brace (hinge on the inside
of the knee), position the inner foam knee pad
aligned over the knee center (the large bony
knot, the adductor tubercle) on the inside of
the knee. For a Lateral (LA) brace (hinge on
the outside of the knee), transfer the knee
center to the outside of the knee and position
the knee pad over that area. NOTE: The brace
should only be applied in the unloaded position
(80°- 90°).
2 3
4. Lower Calf Strap
Apply the lower calf strap by wrapping it around
the calf to the front of shell to engage the
buckle. Adjust the length of the strap using the
hook and fastener on the buckle end of strap.
4
6. Upper Thigh Strap
Wrap the upper thigh strap around behind the
leg and engage the buckle end on opposite
side of the shell. Adjust the length of the strap
using the hook and fastener on the buckle end
of strap.
5. Lower Thigh Strap
Wrap the lower thigh strap firmly around front
of leg and engage strap into hook on opposite
side of shell. Then pull firmly around back of
leg to the buckle area on front of shell. Now
engage buckle and tighten strap to desired
tension. Adjust the length of the strap using the
hook and fastener on the buckle end of strap.
5 6

7. Hinge Adjustment
Stand and walk in the brace to see how it feels
on the leg. Some patients may experience pain
relief prior to adjusting the hinge, due to varying
leg angulations. The brace only applies force
as it approaches full extension. It can only be
adjusted while seated with the leg bent at 90°.
If more force is required, sit down and adjust
the dial to an increased force setting. Walk
again to test for pain relief.
Bledsoe Thruster RLF Application Instructions
Page 3 of 4 CP020218 Rev D 01/07
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9. Locking the Hinge
To guard against accidental movement of the
force dial, use the supplied hex wrench to
lightly tighten the screw.
8. Adjusting to the Brace
NOTE: Only adjust the hinge enough for pain
relief. Walk after each adjustment. Too much
force may cause discomfort and excessive
muscle soreness. Once you reach pain
relief don't adjust the hinge any further. ONE
FURTHER NOTE: It takes at least a week for
the leg to get used to having pressure applied
to it. If there is any pinching from the straps,
bend the leg to 90° and readjust the straps for
comfort. It is important that the straps closest
to the knee are snug, or you will lose brace
effectiveness.
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Bledsoe Thruster RLF Hinge Care Instructions
Figure 1 Figure 2 Figure 3
Figure 4 Figure 5 Figure 6
Figure 7 Figure 8 Figure 9
Figure 10 Figure 11
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