CyMedica ORTHOPEDICS QB1 Post-Operative Knee Brace User Manual

June 5, 2024
CyMedica ORTHOPEDICS

CyMedica ORTHOPEDICS QB1 Post Operative Knee Brace -
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CyMedica Orthopedics
QB1 KNEE BRACE USER’S MANUAL
with Trimmable Straps
Read this manual carefully before operating the QB1 knee brace
Customer Service 1-844-CYM-2014
QB-0090-020
Rev. B

INTRODUCTION

The Medica Orthopedics QB1 post-operative knee brace provides protection and support for knee function after knee ligament reconstruction surgeries including, but not limited to, Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL).
Read this User’s Manual carefully before using the device. Pay attention to the Safety Information.

INTENDED USE

The QB1 post-operative knee brace is an externally applied orthopedic apparatus intended to support, align and improve knee function post knee ligament reconstruction surgery.

EXPLANATION OF SYMBOLS
The following symbols are used in this user manual, on the device packaging, or on the device or accessory labeling. Refer to the QB1 User’s Manual (QB-0090-016 and QB-0090-017) for a glossary of the symbols.

| Reference number; part number
---|---
| Lot number
| Manufacturing date
| Manufacturer name and address
| Follow instructions for use

SAFETY INFORMATION

3.1 WARNINGS & CAUTIONS

  • Carefully read fitting instructions and warnings prior to use. To ensure proper performance of the brace, follow all instructions. Failure to properly position the brace and fasten each strap will compromise performance and comfort.
  • This device will not prevent or reduce all injuries. Proper rehabilitation and activity modification are also essential parts of a safe treatment program. Consult your licensed health care professional regarding safe and appropriate activity levels while wearing this device.
  • For single patient use only.
  • The slide lock and extension/flexion limits are designed to keep the leg positioned properly and are not designed to support the patient’s weight. Applying full body weight to the lock and limits may break the brace and lead to injury.

3.2 QB1 Knee Brace
The QB1 knee brace is used with the QB1 knee conductive garment, refer to QB1 NMES System User’s Manual for information related to the conductive garment.
The following picture shows the QB1 knee brace and the main components. The hinge can be locked out at full extension or a specific angle, or adjusted to limit knee range of motion.CyMedica ORTHOPEDICS QB1 Post Operative Knee
Brace - Fig 5 3 Instructions for Applying the Knee Brace
INITIAL APPLICATION BY A MEDICAL PROFESSIONAL ONLY
Position the Brace:
Sit on the edge of a stable chair
With the straps undone, place the brace behind the knee
Position the hinge brace bars to the midline of the knee
Center the hinges with the knee cap
Secure the Brace:
Be careful to maintain the lateral and medial positions of the hinge bars.
Starting with brace strap A, feed the strap through its associated loop and attach it so the brace is snug against the leg.
Attach remaining brace straps in order:
Brace strap B
Brace strap C
Brace strap D
Verify that the brace bars are aligned along with the midline of the leg.CyMedica ORTHOPEDICS QB1 Post Operative Knee Brace - Fig
6 The brace should fit snug to the leg.
Clinicians may trim excess material as needed. The Alligator strap tabs enable easy strap trimming.
To Trim the Straps:
Remove the Alligator tab from strap ends by pulling up on the fabric adjacent to the rubber logo tab on both sides of the strap.
Trim excess material starting from the end of the strap– take care to not cut it too short.
Replace the Alligator tab by re-attaching the fabric onto both ends of the strap with the hook-and-loop material facing down.
Secure straps.
Using the lock out feature of the QB1 knee brace:
The QB1 knee brace can be locked out at 0° (extension) via the slide lock to prevent knee motion.
Locking the knee brace in extension:
To lock out the brace in extension, fully extend your leg and align the slide lock between the two white lines on the hinge. When positioned, move the slide lock towards your foot to secure.
Ensure that the slide lock is fully seated into its mating slot on the hinge. Repeat for both knee brace hinges. Confirm the slide lock is fully seated on each hinge.
Unlocking the knee brace:
With your leg fully extended, move the slide lock on both brace hinges towards your thigh. Carefully, retract the slide lock to ensure it is completely removed from the mating slot on the hinge.CyMedica ORTHOPEDICS QB1 Post
Operative Knee Brace - Fig 7

3.4 Instructions for Operating the QB1 Knee Brace
The QB1 knee brace can be used to limit or lockout the flexion and extension range of motion of the knee. Each brace has an independent hinge on both sides of the knee joint. The hinge dial is used to adjust the extension and flexion range of motion of its associated hinge. The extension limit can be set to -15° (hyperextension) or from 0° to 90° in 15° increments. The flexion limit can be set from 15° to 135° in 15° increments.
NOTE: The knee brace hinge dials on both sides should always be adjusted to the identical settings prior to use.
Setting the QB1 knee brace extension and flexion limits:
Removing the extension limit:
Rotate the hinge dial towards the EXTENSION setting until the locking disc pops out and releases the extension limit.
Setting the extension limit:
Rotate the hinge dial to the desired EXTENSION setting and push in the locking disc firmly until seated.
Removing the flexion limit:
Rotate the hinge dial towards the FLEXION setting until the locking disc pops out and releases the flexion limit.

CyMedica ORTHOPEDICS QB1 Post Operative Knee Brace - Fig
8

Using the Locking Disc to set
Extension Limit at 30º| Using the Locking Disc to set
Extension Limit at 90°

Locking the Hinge Dial
Once the desired EXTENSION and FLEXION Limits have been set, the hinge dial should be rotated to the LOCK position to prevent unintentional rotation of the hinge dial.CyMedica ORTHOPEDICS QB1 Post Operative Knee Brace - Fig
9

NOTE: To lock the hinge at any setting (in 15° increments), set the extension and flexion limits to the same number. To accomplish this, set the flexion limit first, then set the extension limit. To unlock, disengage the extension first, and then the flexion limit.
3.5 Instructions for Detaching the QB1 Knee Brace
Your doctor may request to use the knee brace for a period of weeks. The knee brace may be removed from the QB1 conductive garment. To do this, detach the straps and
remove them from the associated loops. Then, peel the brace bars, straps, and pockets away from the sides of the conductive garment. The parts removed may be discarded or stored as desired.

CyMedica Orthopedic
2120 East 6th Street
Suite 8
Tempe, AZ 85281 USA
03/2022
QB-0090-020 Rev. B,

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