CyMedica ORTHOPEDICS QB1 Post-Operative Knee Brace User Manual
- June 5, 2024
- CyMedica ORTHOPEDICS
Table of Contents
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.
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.
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.
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.
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.
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,