OrthAlign KneeAlign 2 System User manual

Surgical Technique Manual
Tibia and Distal Femur Navigation
KneeAlign®2 System
1/2012 001029 Rev K
120 Columbia, Suite 500
Aliso Viejo, CA 92656
866.582.0879
www.orthalign.com
OrthAlign is committed to providing surgeons with
user-friendly, cost-effective, surgical navigation products
for precise alignment.
For more information about the KneeAlign® 2 System,
please contact us at 866.582.0879 or [email protected].
About OrthAlign, Inc.

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KneeAlign®2 System Surgical Technique Manual
SET UP
Install Sensor Battery
a Open navigation unit package and pass sterile inner
blister package into operative field.
b Remove navigation unit and sensor battery from
blister pack.
c Turn navigation unit on by pressing center button.
d Insert battery into sensor and close cover.
TIP: Sensor LED will slowly flash yellow to indicate battery
has been inserted correctly.
LED will momentarily flash green and navigation unit
will move to next screen when sensor is found.
Confirm Sensor ID
• Navigation unit screen displays serial number of
sensor to which it is paired. If this number matches
that marked on sensor being used, press center
button.Otherwise, press left button to let navigation
unit find another sensor. Repeat until correct sensor
serial number is displayed.
TIP: Navigation unit will move to next screen when pairing
is confirmed.
Step
Step
1
2
Table of Contents
SETUP Step 1Install Sensor Battery..................................................... 1
Step 2Confirm Sensor ID........................................................... 1
Step 3Attach Bracket.................................................................. 2
Step 4Hold Horizontally............................................................ 2
Step 5Hold Vertically................................................................... 3
Step 6Verify Calibration............................................................. 3
Step 7Assemble Femoral Jig................................................... 4
Step 8Assemble Tibial Jig ......................................................... 5
Step 9Select Knee ........................................................................ 6
Step 10 Select Bone........................................................................ 6
FEMUR Step 1Secure on Femur............................................................. 7
Step 2Input A/P Offset............................................................... 7
Step 3Attach Sensors ................................................................. 8
Step 4Maneuver Leg................................................................... 8
Step 5Set Resection Plane........................................................ 9
Step 6Set Resection Depth....................................................10
Step 7Finished Femur ..............................................................11
TIBIA Step 1Attach Sensors ...............................................................12
Step 2Secure on Tibia...............................................................12
Step 3Match Probe Offsets....................................................13
Step 4Register Lateral Malleolus.........................................14
Step 5Register Medial Malleolus.........................................14
Step 6Set Resection Plane......................................................15
Step 7Set Resection Depth....................................................16
Step 8Finished Tibia..................................................................17
DISPOSAL ..................................................................................................................17
TROUBLESHOOTING Setup......................................................................................................18
Femur Maneuver..............................................................................18
Tibia........................................................................................................19
System...................................................................................................19
SPECIFICATIONS Ordering Information.....................................................................20
This technique guide describes the proper use of the KneeAlign® 2
System. This system is not compatible with its previous generation,
the KneeAlign® System and the two systems should not be used
in the same operating environment. Any reference below to the
“navigation unit” or “sensor” refers to the KneeAlign® 2 unit and
Reference Sensor 2 system components.
KneeAlign®2 System
precise •alignment •simplified
+ –
a
dc
b

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2
SET UP SET UP
Attach Bracket
• Attach navigation unit to mounting bracket by sliding
unit in the direction indicated by arrow on bracket.
Attach sensor to coupler at other end of mounting
bracket as shown.
• Press center button when completed.
If navigation unit is dropped on floor, it must be
discarded. If sensor is dropped on floor, it must be
returned to manufacturer for verification of function
and calibration.
Hold Vertically
Calibration Step 2:
Rest navigation unit vertically on level surface and hold
steady with ball in circle. Navigation unit will beep twice
and automatically proceed to next screen.
Hold Horizontally
Calibration Step 1:
Rest navigation unit horizontally on level surface with
screen facing upwards and hold steady with ball in circle.
Navigation unit will beep twice and automatically
proceed to next screen.
TIP: During calibration steps:
Navigation unit must be maintained in steady position,
or calibration will not be accepted. A red hand will flash
on screen to indicate that unit is not steady.
Level must be green, but ball does not need to be in
exact center of circle.
Verify Calibration
Calibration Step 3:
Rest navigation unit in angled position on level surface
and hold steady with ball in circle. Navigation unit will
beep twice and automatically proceed to next screen.
TIP: Displayed angles should be 2° or less.
If navigation unit does not proceed to the next screen
after several seconds, check that navigation unit and
sensor are correctly attached to the bracket and press
left button twice to repeat from step 4.
Step
Step
Step
Step
3
4
5
6

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SET UP SET UP
Assemble Tibial Jig
• Assemble tibial jig as follows:
• Set fixation arm on proximal end of tibial jig to “Left”
or “Right” for leg being operated on.
• Ensure that varus/valgus and posterior slope levers
of tibial jig are locked.
• Attach midline probe (a) to proximal end of tibial jig.
• Attach shin spacer (b) to tibial jig.
• Attach ankle tube (c) to distal end of tibial jig and lock
in place.
• Attach malleolar probe (d) to ankle tube.
• Press center button on navigation unit when completed.
TIP: Fixation arm is spring-loaded and may be adjusted by
pulling arm away from jig, then rotating.
TIP: Shin spacer may already be attached.
TIP: Squeeze button on ankle tube and insert malleolar probe
through slot until it reaches limit of its travel.
Use curved malleolar probe to extend range for extremely
long or short tibias.
Assemble Femoral Jig (cont.)
• Once assembled, ensure microblock is in neutral position
by adjusting varus/valgus and flexion/extension screws
with ball driver.
• Press center button when completed.
TIP: Plate and bracket of microblock should be approximately
parallel to each other when viewed from front and side.
Step Step
78
5
Assemble Femoral Jig
a Push guide rod in direction indicated by arrow labeled
“Lock” until it stops.
b Fully extend slider to its maximum setting in order to
position guide rod against gold latch. Ensure gold latch
is unlocked.
c Lock guide rod by sliding gold latch into position.
d Slide femoral cutting block onto guide rod in direction
indicated by arrow on cutting block labeled“Assemble”
until it locks into place.
Lock
Maximum
Setting
Assembled Tibial JigTibial Jig Assembly Order
b
a
d
c
Neutral Position
F/E V/V
Plate Bracket
a
dc
b

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KneeAlign®2 System Surgical Technique Manual
FEMUR
Secure on Femur
• Expose knee.
• Place knee in flexion and seat microblock on femur
in approximately neutral varus/valgus and flexion/
extension position.
• Insert headed pin in center hole of microblock slider
and drive it into most distal point of sulcus of trochlea,
directing it toward center of femoral head.
TIP: A typical IM drill placement approximates this point.
Do not bias medially or laterally.
• Rotate microblock to approximately line up with
Whiteside’s line.
• Slide microblock in anterior/posterior direction as
necessary to achieve three-point contact to femur. Pin
medial and lateral feet of instrument against condyles,
using headed pins provided in instrument tray.
• Press center button when completed.
Hardened, stainless steel headed pins provided in
instrument tray should be used.
Do not impact or hammer system components.
TIP: Verify that there is approximately 10 mm of clearance
between femoral cutting block and anterior condyles.
Input A/P Offset
• Read anterior/posterior offset position of center pin
on microblock slider scale.
• Enter offset value into navigation unit by pressing
right button until correct number is displayed on
bottom right corner of screen.
• Press center button when completed.
TIP: If displayed value exceeds desired offset, continue
to press right button to cycle back to desired value.
Step
Step
Step
10
1
2
KneeAlign®2 System Surgical Technique Manual
6
SET UP
Select Knee
• Press button to select “L” (Left) or “R” (Right) for leg
being operated on.
Select Bone
• Press button to select tibia or femur.
TIP: If “TIB” is selected, proceed to Tibia resection steps
on page 12.
If “FEM” is selected, proceed to Femur resection
steps on page 7.
Step 9
Whiteside’s
Line
Epicondylar
Axis
Read A/P
Offset

Maneuver Leg
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FEMUR FEMUR
Attach Sensors
• Attach navigation unit and sensor to microblock.
Align ball in center of rectangular box on side of screen
by changing angle of femur until box turns green.
TIP: Navigation unit on mounting bracket should be attached
to coupler adjacent to white dot on microblock. Sensor
should be attached to coupler adjacent to black dot
on microblock.
TIP: If sensor is not attached correctly, box on the side of screen
will not appear and screen will read “Mount Sensor Here.”
Once navigation unit and sensor are attached, do not
adjust varus/valgus or flexion/extension screws of
microblock until after completing hip point registration
(Femur–Step 4).
TIPS FOR MANEUVER:
Maneuver must be completed before beeping stops
and as rapidly as possible.
TIP: Maneuver leg using two hands, grasping behind knee
and ankle. Do not hold navigation unit or femoral jig.
Rotate knee between 10° and 45° subtended during
registration maneuver.
For accurate results, it is important that hip is kept
stationary during registration. Knee must be returned
to start position (within ± 2 cm and ± 5° rotation).
TIP: Following maneuver completion, during hip point
calculation, navigation unit screen will provide user with
feedback on speed of maneuver in medial-lateral (M/L)
and anterior-posterior (A/P) planes. Green bars displayed
for a given plane indicate that speed of the maneuver
is sufficient in that plane. Red bars displayed for a given
plane indicate that speed in that plane is insufficient.
TIP: In the event maneuver is too slow in a given plane, or
otherwise insufficient, navigation unit screen will provide
instructions to repeat maneuver.
Maneuver Leg
• Hold femur stationary until green light appears
on navigation unit screen and unit starts to beep
continuously. As soon as navigation unit starts
beeping, maneuver femur rapidly as follows while
keeping the pelvis stationary:
• First, move knee in medial-lateral arc by internally
and/or externally rotating hip while keeping heel
on table, and maintaining knee in flexion.
• Next, move knee in sagittal plane by flexing and
extending hip.
Step
Step
3
4
Hold Still in Start Position Move Knee Medial/Lateral Flex/Extend Hip Return Gently to Start Position, Hold Still
Step 4

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FEMUR FEMUR
Set Resection Plane
• Set desired varus/valgus and flexion/extension angles
using ball driver to adjust microblock’s navigation screws.
• Press center button when completed.
TIP: Navigation unit must be oriented within its operating
range in order for unit to display resection angles.
TIP: Varus/valgus and flexion/extension angles are measured
relative to mechanical axis of femur.
Do not attempt to adjust cutting block orientation by
applying force to jig. Angles must be adjusted using ball
driver to adjust screws prior to pinning the cutting block.
Applying excessive torque to adjustment screws at limit
of travel will cause damage to microblock.
If bone interferes with cutting block while setting resection
angle, microblock has been pinned in too much flexion.
Two alternatives may be considered:
1. Use sagittal saw to trim interfering bone to provide
additional travel for cutting block. Care should be taken
not to remove too much bone, which could cause
notching or interfere with subsequent sizing.
2. Unpin microblock and re-pin closer to neutral flexion
angle, repeating Femur–Steps 1-4.
Set Resection Depth (cont.)
TIP: Resection depth is indicated by scale on anterior face of
guide rod, viewed at top of distal guide. Shoulder on guide
rod stops distal guide at 9 mm resection depth. Resection
depth can be increased in 1 mm increments by squeezing
pushbutton and pulling distal guide up.
Resection depth measurement should be set according
to implant manufacturer’s recommendations.
Resection depth scale is relative to position of distal guide.
Ensure that distal guide paddles remain flush on highest
point of condyle being referenced.
TIP: When pinning the cutting block, take care to avoid
applying excessive force that could alter intended varus/
valgus and flexion/extension angles.
To prevent potential interference of oblique pin with microblock
pins, do not insert oblique pin until microblock has been removed.
Use angel wing stylus to verify resection level prior to resection.
TIP: If more bone needs to be resected, move cutting block
proximally on parallel pins (+2mm, +4mm). Required
saw blade thickness is 1.27 mm (or 0.050 in).
If distal guide contacts condyle before the desired depth
setting is reached, microblock has been pinned in too much
extension. Unpin microblock and re-pin closer to neutral
flexion angle, repeating Femur–Steps 1-4.
Set Resection Depth
• Remove navigation unit/bracket assembly, and sensor
from microblock.
aAttach distal guide to microblock guide rod by
squeezing pushbutton (b), and slide distal guide to
desired resection depth (c).
dPress gold latch on side of microblock to unlock guide
rod/cutting block assembly from its maximum anterior
position. Position distal guide paddles flush against
condyles, and slide cutting block posteriorly to
contact femur.
ePin distal femoral cutting block to anterior femur
using most proximal holes using headless pins
provided in instrument tray.
f Remove pins from microblock by pulling in distal
direction, while securely holding cutting block in place.
Fix cutting block with oblique pin if desired.
gResect distal femur.
• Press center button when completed.
Finished Femur
• Use of navigation unit for distal femoral resection
is finished.
TIP: Press center button to continue if additional
use is appropriate in this procedure.
Step Step
56
F/E
V/V
Resection
Scale Unlock
Removal of navigation
unit from bracket
a
e
d
g
c
f
b
Step Step
6 7

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TIBIA TIBIA
Attach Sensors
• Remove navigation unit and sensor from
mounting bracket and attach to tibial jig.
• Press center button when completed.
TIP: Attach sensor so that it is on lateral side of tibial jig
(opposite fixation arm) during procedure.
Secure on Tibia (cont.)
Midline probe should not be impacted into tibial plateau.
During pinning, ensure that midline probe is not pulling
away from main tibial jig body. If it has, push probe down
to reseat.
After pinning, fixation arm should be inspected to verify it
has not pulled away from main tibial jig body and that it
is seated fully within notch in jig body. If fixation arm has
disengaged from jig body, push jig towards tibia to fully
reseat fixation arm in jig body.
TIP: Hardened, stainless steel pins provided in instrument
tray should be used for pinning KneeAlign® 2
instrumentation.
TIP: If jig appears in extension relative to tibia, remove shin
spacer. This may be the case for very obese legs.
Secure on Tibia
aPull malleolar probe to maximum anterior position in
order to avoid interference during placement of jig.
bPlace tibial jig on anterior tibia, aligning etched line on
fixation arm of jig with medial third of tibial tubercle.
cPosition tip of midline probe just posterior to insertion
of Anterior Cruciate Ligament (ACL).
dSecure fixation arm to tibia with at least two headed
pins provided in instrument tray.
eSecure mid-tibia v-rest of tibial jig with calf strap.
• Press center button when completed.
Match Probe Offsets
• Confirm tip of midline probe is placed just posterior
to insertion of ACL.
• Read number on midline probe where arrow indicates.
• Release PS and V/V levers to allow jig to move freely.
• Set matching number on malleolar probe by pushing
button on ankle tube and sliding malleolar probe to
desired position.
• Press center button when completed.
Step
Step
Step
Step
1
2
2
3
a
d
c
e
e
b
Release
Levers
Release
Levers

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TIBIA TIBIA
Register Lateral Malleolus
• Palpate lateral malleolus and place cup of malleolar
probe on its apex.
• Press center button to register lateral malleolus.
TIP: Extend jig distally if necessary, by releasing ankle
tube latch.
In event that leg is positioned at orientation outside of
range of KneeAlign® 2 system, box at top center of screen
will turn orange. Change position of leg until black ball
is within square box and box has turned green.
TIP: A double beep will sound on registration.
Navigation unit must be maintained in steady position
or red hand will flash on screen.
Ankle tube should be locked during registration.
Set Resection Plane
• Retract malleolar probe to maximum anterior position.
• Move distal end of tibial jig to obtain desired varus/
valgus and posterior slope angles and lock in place
with side levers.
TIP: Malleolar probe may be adjusted to assist in setting
posterior slope angle.
Do not use malleolar probe to set posterior slope angle
if posterior slope lever is locked.
After locking levers, do not move jig relative to the tibia.
Pushing or pulling locked bars of the jig may introduce
errors in navigation accuracy.
KneeAlign® 2 System does not display measurement
values when oriented outside of its operating range.
Change position of leg until black ball is within
rectangular box and box has turned green.
Register Medial Malleolus
• Palpate medial malleolus and place cup of malleolar
probe on its apex. Press center button on navigation
unit to register medial malleolus.
TIP: A double beep will sound upon registration.
After registration, do not move base of jig relative to tibia.
Keep fixation arm and v-rest in their attached positions.
Pushing or pulling fixed base of jig may introduce errors
in navigation accuracy.
• Press center button on KneeAlign® 2 when this
step is completed and remove midline probe
by pulling straight up.
Step
Step
Step
4
5
6
V/V
Posterior
Slope
P/S
Lock
V/V
Lock

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TIBIA TIBIA
DISPOSAL
Set Resection Depth
• Insert tibial cutting block and rotate it into position against
tibia. Attach resection stylus to tibial cutting block.
• Push release plate of tibial jig up to adjust height of
the tibial cutting block (locking mechanism on cutting
block is in 1 mm increments.) Once tibial cutting block
is at desired position, pin in place with headless pins
provided in instrument tray using distal pin holes.
• Resect tibia.
• Press center button when completed.
Finished Tibia
• Use of navigation unit for tibial resection is finished.
TIP: Press the center button to continue if additional use is
appropriate in this procedure.
Prior to disposal, power off navigation unit by pressing
left and right buttons for 2 seconds.
Prior to resecting tibia, confirm that posterior slope and
varus/valgus angles still match desired values. Use angel
wing stylus to confirm resection level and perform a
visual confirmation of alignment.
TIP: While setting resection depth, stylus end should not be
pressed into tibial plateau.
TIP: Resection depth measurement should be set according
to implant manufacturer’s recommendations.
TIP: If additional support is required, place oblique pin
through tibial cutting block.
TIP: If additional resection is required, move cutting block
down on pins (2 mm). Tibial jig will need to be removed
to facilitate this.
TIP: Required saw blade thickness is 1.27 mm (or 0.050 in).
Verify resected tibia with drop rod.
aTo power off navigation unit, press and hold down
left and right buttons simultaneously.
• Navigation unit must be powered off and discarded.
bBattery must be reomoved from sensor and discarded
• Sensor, calf strap, and pins must NOT be discarded.
These items should be returned to their designated
locations in the instrument tray.
Step Step
7 8
17
Release
Cutting
Block
Adjust Resection Depth
a b

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18 19
TROUBLESHOOTINGTROUBLESHOOTING
Sensor not attached correctly to femoral jig.
Reattach sensor as shown in Screen F3.
Generic hip point failure. Press center button to repeat maneuver.
No maneuver detected. Press center button to repeat.
Calibration step during set-up invalid due to incorrect attachment of sensor.
Reattach sensor correctly and repeat validation steps.
Press center button to repeat maneuver, increasing femoral rotation to at least 10°.
Jig pinned out of range of valid varus/valgus and/or flexion/extension values.
Adjust or re-pin jig into neutral position and press center button to repeat maneuver.
If jig re-pinned, back up to Femur Step 1.
Hold knee steady before beginning maneuver.
Sensor medial-lateral position on tibial jig was changed during registration process.
Attach sensor to lateral side of tibial jig and restart tibial navigation Step 3
(Register Lateral Malleolus).
There is a major system fault and navigation unit must be turned off and replaced.
Please recover faulty unit and return to manufacturer for analysis.
Hip point registration maneuver performed too slowly in either, or both anterior/posterior
(A/P) or medial-lateral (M/L) planes. Press center button to repeat maneuver at higher
speed sufficient to obtain green color bars for both A/P and M/L speeds.
Sensor signal is lost. Remove and reattach sensor battery to re-establish connection.
Hip point registration maneuver not finished prior to end of navigation unit beeping stream.
Press center button to repeat maneuver, finishing maneuver and returning knee to
starting position prior to end of unit beeping stream.
Knee was not returned to starting position at end of maneuver. Press center button to
repeat maneuver, returning knee to within ± 2 cm and ± 5° rotation of starting position
prior to end of unit beeping stream.
During hip point registration, software conducts a check for consistency of data
throughout the maneuver. Inconsistent data triggers a rejection of registration. This
can be caused by movement of pelvis, inadequate fixation of microblock to femur or
excessive deceleration when heel is repositioned at the end of maneuver. If maneuver
was conducted without these errors, press right button to proceed. Press center button
to repeat maneuver if desired, ensuring the following:
• Use three headed pins (provided with KneeAlign® 2 System) to mount the microblock
to femur. Ensure microblock is secured with firm, three-point contact to femur.
• At end of hip point maneuver, place heel down gently.
• Stabilize pelvis during maneuver and ensure femur is free to move through full range
of motion.
SETUP FEMUR MANEUVER (cont.)
FEMUR MANEUVER
TIBIA
SYSTEM

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Note: For cleaning and sterilization instructions, please refer to the Instructions for Use.
INSTRUMENT SPECIFICATIONS
ORDERING INFORMATION
Product Description Catalog Number
KneeAlign® 2 Navigation Unit 133631
KneeAlign® 2 Instrument Set Replacement Parts
KneeAlign® 2 Tibial Jig Body 401594
KneeAlign® 2 Mounting Bracket 402046
Ankle Tube 401582
Ball Driver (2.5 mm) 402048
Calf Strap 401592
Distal Guide Assembly 402043
Femoral Cutting Block Assembly 402045
Malleolar Probe, Curved 401573
Malleolar Probe, Straight 401572
Microblock 402042
Midline Probe Assembly 401571
Pin Driver, Tri-Flat 402067
Reference Sensor 2 133632
Resection Stylus, Adjustable, Captured 401587
Shin Spacer 401548
Threaded Pin, Headed (46 mm, 2-Pack) 402395
Threaded Pin, Headless (65 mm 2-Pack) 402394
Tibial Cutting Block, Left 401579
Tibial Cutting Block, Right 401578
Curved Malleolar
Probe
Tibial Cutting
Blocks
(left and right)
Sensor
Ankle
Tube
Calf
Strap
Straight
Malleolar
Probe
Shin
Spacer
Threaded Pin
Headed
(46 mm)
KneeAlign® 2
Tibial Jig Body
Pin
Driver
Adjustable
Stylus
Ball
Driver
Distal
Guide
MicroblockMidline
Probe
Mounting Bracket Distal Femoral Cutting Block
Threaded Pin
Headless
(65 mm)