Bledsoe DUO - User Manual

DUO by Bledsoe
B.
C.
Fastening Lower Calf Strap
4. Insert the over-center buckle into the base on the lower calf
shell of the brace. Push the buckle in until you hear the gray
levers click on both sides.
Adjust strap until a comfortable t is achieved. (If the strap tab
reaches its limit without achieving the desired t, see strap length
adjustment in gure F.)
Unfasten Buckles
1. Release all four straps on the back side of the brace
by squeezing the gray levers on either side of the buckle
and withdrawing the over-center buckle. Loosen the front
strap(s).
Positioning the Brace (Fig. A)
2. With the knee bent at 45°, lay the brace on the leg and
align the hinge as shown above. Position the center of the
hinge on an imaginary line that goes across the top of the
knee cap. Push the hinges posteriorly until the hinges are
in the center of the knee joint when viewed from the side.
Anchoring the Brace (Fig. B)
3. Wrap the upper rear calf strap around the calf as high
as possible over the calf muscle.
Insert the over-center buckle into the base. Push the
buckle until you hear the gray levers click on both sides.
Adjust the strap by releasing the hook and pile tab and
pull the strap until a snug and comfortable t is achieved.
(Fig. C)
Fastening Rear Thigh Straps
5. Following the same instructions as in Steps 3 and 4, fasten
the lower and then upper rear thigh strap.
D.
E.
A.
Adjusting Front Thigh Strap (Fig. E)
8. Tighten the front thigh strap. Note: Overtightening the front
thigh strap can cause the brace not to function properly.
Stand up and walk or jog around to see how your new DUO
brace feels. Straps should not be so tight that blood circulation
is restricted. Re-adjust as needed.
If this is your rst time to wear a functional knee brace, it might
take a few hours of wear to get used to how it feels.
Adjusting Front Tibia Strap (Fig. D)
6. Tighten the front tibia strap. If the strap overlaps too far,
see strap length adjustment in figure F.
Center the strap pad.
© 2011 Medical Technology Inc., d/b/a Bledsoe Brace Systems.
All Rights Reserved.
2601 Pinewood Drive, Grand Prairie, Texas, 75051, USA
Toll Free Tel.1.888.bledsoe ( 253.3763)
Local 972.647.0884 • Local FAX 972.660.5495
www.bledsoebrace.com
For product information or questions pertaining to sales or service, please contact the
sales representative in your area or Bledsoe Brace Systems directly.
CP020255 Rev A 03/11

Summary

Bledsoe DUO Brace Usage

Unfasten Buckles

Release all four straps by squeezing gray levers and withdrawing the over-center buckle. Loosen front strap(s).

Positioning the Brace

Align the brace with the knee bent at 45°, positioning the hinge at the top of the knee cap and in the center of the joint.

Anchoring the Brace

Wrap upper rear calf strap high, insert buckle, push until clicks, adjust strap for snug fit.

Fastening Lower Calf Strap

Insert lower calf strap buckle into base, push until clicks, adjust for comfortable fit.

Fastening Rear Thigh Straps

Fasten the lower and then upper rear thigh straps following previous step instructions.

Adjusting Front Tibia Strap

Tighten the front tibia strap, center the strap pad. Adjust length if overlaps too far.

Adjusting Front Thigh Strap

Tighten the front thigh strap. Avoid overtightening to ensure proper function.

Strap and Load Adjustments

Strap Length Adjustment

Adjust strap length using hook and pile fastener at the end opposite the tab. Center the strap pad.

Adjust OA Load

Use the 'b' tool to loosen screws, slide arm down to decrease or up to increase load, then retighten screws.

Important Information and Warnings

Indications and Contraindications

For medial/lateral osteoarthritis to decrease joint pain. Contraindicated for cross-treatment of osteoarthritis.

Safety Warnings and Cautions

Federal law restricts sale. For single patient use only. Modify activity and seek medical attention if pain occurs.

Warranty Information

90 days for wraps/pads/straps, 12 months for parts, 3 years for hinge breakage. Subject to Bledsoe's Limited Warranty.

Overview

1. Function Description
2. Important Technical Specifications
3. Usage Features
4. Unfastening Buckles
5. Positioning the Brace (Fig. A)
6. Anchoring the Brace (Fig. B)
7. Fastening Lower Calf Strap
8. Fastening Rear Thigh Straps
9. Adjusting Front Tibia Strap (Fig. D)
10. Adjusting Front Thigh Strap (Fig. E)
11. Adjusting OA Load (Fig. G)
12. Maintenance Features
13. Strap Length Adjustment (Fig. F)
14. Cautions and Warnings

The Bledsoe DUO brace is a medical device designed to address medial or lateral osteoarthritis by decreasing joint pain through the creation of space between the bones on the affected side of the knee. It is offered for sale by or on the order of a physician or other qualified medical professional and is intended for single-patient use only.

Function Description:

The DUO brace works by applying a corrective force to the knee joint, which helps to unload the affected compartment (medial or lateral) and reduce pain. The brace is adjustable to accommodate different levels of osteoarthritis and patient comfort.

Important Technical Specifications:

• CE Mark: The device complies with Council Directive 93/42/EEC concerning Medical devices.
• Warranty:
  • 90 days for wraps, pads, straps, and normal wear components.
  • 12 months for all other parts.
  • 3 years against hinge breakage.
  • Warranties apply to devices not modified or subjected to misuse, abuse, or neglect.
• Temperature Exposure: Avoid leaving the device in temperatures exceeding 150°F (65°C) for extended periods.

Usage Features:

Unfastening Buckles:

1. Release the four straps on the back side of the brace by squeezing the gray levers on either side of the buckle and withdrawing the over-center buckle.
2. Loosen the front strap(s).

Positioning the Brace (Fig. A):

1. With the knee bent at 45°, lay the brace on the leg.
2. Align the hinge as shown, positioning the center of the hinge on an imaginary line across the top of the kneecap.
3. Push the hinges posteriorly until they are centered in the knee joint when viewed from the side.

Anchoring the Brace (Fig. B):

1. Wrap the upper rear calf strap around the calf as high as possible, over the calf muscle.
2. Insert the over-center buckle into the base.
3. Push the buckle until the gray levers click on both sides.
4. Adjust the strap by releasing the hook and pile tab and pulling the strap until a snug and comfortable fit is achieved (Fig. C).

Fastening Lower Calf Strap:

1. Insert the over-center buckle into the base on the lower calf shell of the brace.
2. Push the buckle in until the gray levers click on both sides.
3. Adjust the strap until a comfortable fit is achieved. If the strap tab reaches its limit without achieving the desired fit, refer to strap length adjustment in figure F.

Fastening Rear Thigh Straps:

1. Follow the same instructions as for the calf straps (Steps 3 and 4).
2. Fasten the lower rear thigh strap first, then the upper rear thigh strap.

Adjusting Front Tibia Strap (Fig. D):

1. Tighten the front tibia strap. If the strap overlaps too far, refer to strap length adjustment in figure F.
2. Center the strap pad.

Adjusting Front Thigh Strap (Fig. E):

1. Tighten the front thigh strap.
2. Note: Overtightening the front thigh strap can cause the brace not to function properly.
3. Stand up and walk or jog around to assess comfort. Straps should not be so tight that blood circulation is restricted. Re-adjust as needed.
4. It may take a few hours of wear to get used to the brace if it's your first time wearing a functional knee brace.

Adjusting OA Load (Fig. G):

1. The DUO brace comes with the setting at 4.
2. Wear the brace and walk around to check for pain relief.
3. If pain relief is not achieved, remove the brace.
4. Remove the "b" shaped tool hanging on the brace.
5. Insert the tool into the top screw and turn to the left to loosen. Repeat with the bottom screw.
6. To decrease the amount of load, slide the arm down to a lower setting.
7. To increase the amount of load, slide the arm up to a higher setting.
8. Use the tool to tighten the screws by turning it to the right until snug.
9. Reapply the brace and walk around to check for comfort and pain relief. Repeat this process until desired pain relief is achieved.

Maintenance Features:

Strap Length Adjustment (Fig. F):

1. All straps have additional length adjustment at the end opposite the tab.
2. Release the strap and adjust its length using the hook and pile fastener.
3. Center the strap pad.

Cautions and Warnings:

• Contraindications: The DUO is contraindicated to treat medial osteoarthritis with a lateral osteoarthritis brace or to treat lateral osteoarthritis with a medial osteoarthritis brace.
• Activity Modification: Activity modification and proper rehabilitation are essential. Discontinue use and seek medical attention if additional pain or symptoms occur.
• Injury Prevention: This device will not prevent or reduce all injuries.
• Fitting Instructions: Carefully read fitting instructions and warnings prior to use. Failure to properly position the brace and fasten each strap will compromise performance and comfort.
• Device Damage: The device may be damaged by unusual activities (sports, falls, accidents) or exposure to debris or liquids.
• Temperature Exposure: Do not leave the device in 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 to avoid the risk of accident and possible injury.
• Reuse: This device is not intended for reuse on a second patient.

Bledsoe DUO Specifications

General

Brand	Bledsoe
Model	DUO
Category	Personal Care Products
Language	English