Fabtech Crossover extensible knee User manual

Crossover™ Extensible Knee

“Infinite Possibilities”

Congratulations on your decision to purchase a Crossover™ Extensible Knee! We have taken our original

Bartlett Tendon Knee (BTK) design and made it even better! The new Crossover™ is an ambulatory Extensi-

ble knee that transforms into a sports knee in less than three minutes!

This state-of-the-art prosthetic knee system will be very gratifying if you service and maintain it accordingly.

Please enter the serial numbers of your knee below. You will provide this number if the knee unit requires

servicing. Serial numbers are located on the knee frame under the protective cover.

This owner's manual contains the latest information for this model (as of June 2016). Future minor differ-

ences due to developments in the knee design cannot be ruled out completely.

All specifications are non-binding. LEFTSIDE Industries (Leftside) specifically reserves the right to modify or

delete technical specifications, prices, colors, forms, materials, services, designs, equipment, etc., without

prior notice and without specifying reasons, to adapt these to local conditions, as well as to stop production of

a particular model without prior notice. Leftside accepts no liability for delivery options, deviations from illus-

trations and descriptions, as well as misprints and other errors. The models portrayed (via included illustra-

tions) partly contain special equipment that does not form part of the regular scope of delivery.

Reproduction, even in part, as well as copying of all kinds, is permitted only with the express written permis-

sion of the copyright owner.

1. Multidurometer impact/kneeling pads

2. ABS protective cover

3. ABS protective X/CAM™ covers

4. Rubber socket flexion limiters

5. Urethane lower frame bumpers

6. Easy to access “On Demand” shock controls

7. RT3 pneumatic/hydraulic shock

Crossover™ Knee Walking Configuration

1. X/CLIP™ removable composite tendon connectors

2. Urethane tendons

3. X/CAM™ 3 position guide wheels

4. Urethane lower tendon guide wheels

5. Lower tendon retaining clamp

6. Multidurometer impact/kneeling pads

7. ABS protective cover system

8. SS removable X/CAM™ locking pin

9. Rubber socket flexion limiters

10. RT3 pneumatic/hydraulic shock

11. Tendon lock plate

Crossover™ Knee Sport Configuration

Crossover ™ Knee Parts

1. Multidurometer impact/kneeling pads

2. Urethane lower tendon guide wheels

3. Urethane lower frame bumpers

4. X/CAM™ 3 position guide wheels

5. Lower tendon retaining clamp

6. Urethane tendons

7. X/CLIP™ removable composite tendon connectors

8. RT3 shock pump

9. ABS X/CAM™ cover

10. ABS protective cover, knee frame

11. RT3 pneumatic/hydraulic shock

Crossflex™ Preflexion Wedges

1. 20° Crossflex™ wedge

2. 30° Crossflex™ wedge

3. 40° Crossflex™ wedge

When installing Crossflex™ preflexion wedges, take care as to not tear the foam

section that locks into the knee unit.

Note: For instructional video visit www.leftsideindustries.com

Lower Tendon Connector

1. Placement of tendons into lower connector

2. Back locking plate attached to connector

3. Lower tendon connector

4. Lower tendon connector in open position

5. Lower tendon connector in closed position with locking plate

General Knee Description 1

Design Features & Function 1

Crossover™ Knee Kit Contents 2

Compatible Activities, Sports and Rehabilitation 3

New Features and Benefits 4

Technical Specifications 4

Understanding the Crossover™ Knee System 5

Ambulation Configuration 5

Sport Configuration 5

How the Systems Work Together 6-8

Tendons 6

Upper Tendon Connectors 6

Lower Tendon Connector 7

X/CAM™ Guide Wheels 7

RT3 Shock 8

Crossflex™ Preflexion Wedges 8

“VED” Variable Extension Dampening System 8

Alignment and Initial Ambulation Settings 9-14

Alignment and First Time Knee Set Up 10

Understanding Shock Controls 11-12

Walking the Patient and Adjusting the Shock 13-14

Sports Set Up 15-17

X/CAMs™ 15

Lower Tendon Guide Rollers 15

Lower Tendon Retaining Connector 16

X/CLIP™ Upper Tendon Connectors 16

Tendons Set Up 17

Crossflex™ Preflexion Wedges Set Up 17

Baseline Activity Recommendations Chart 18-20

Knee Maintenance 20-22

Warranty 23-24

Service Contact Information 25

Technical Support Contact 25

L-Code Information 25

Component Options and Creative Solutions 25

Set Up Reference Notes 26

Parts List 26

X/CLIP™ Mounting Template 27

Table of Contents

General Knee Description

Designed exclusively for lower limb prosthetic fittings, the Crossover™ knee is a monocentric (single axis)

articulated Extensible knee that can be used for general ambulation or—with simple additions/adjustments—

can be used for high activity sports. Designed similar to the Mauch S-N-S knee unit, the Crossover™ knee

has the advantage of having the ability to add a patented highly adjustable Tendon and Three-Position X/

CAM™ system when the user wants to participate in high activity sports or other activities.

Design Features & Function

 Single-axis pneumatic/hydraulic knee system with swing and stance control adjustments

 Designed for multispeed ambulation and sport activities

 Adjustable Variable Extension Dampening “VED” bumper system (kneeling and impact)

 Multi-faceted mode selector to control flexion and extension

 Patented urethane tendon and Three (3) Position X/CAM™ system, offering infinite tunable resistance

and return in a removable Extensible format

 Crossflex™ preflexion foam wedges for sport activities. Three pack kit comes in 20°, 30° and 40° degree

wedge settings

 Removable ABS protective impact cover

 Ultra lightweight CNC machined 6061-T aircraft aluminum frame with stainless steel inserts

 Oilite™ self-lubricating bushings:

 No maintenance with increased durability

 Smooth motion in light use or heavy impact situations

 Reduced play

 All parts serviceable

 Water and salt water resistant

Crossover™ Kit Contents

The Crossover knee kit comes with everything you will need to get your patient up and walking and participat-

ing in sports or other high activities.

Kit Contents: (PN: 1001-3)

 Crossover™ Knee with 75 durometer Variable Extension Dampening “VED” bumpers (upper/

lower)

 Protective ABS impact covers with X/CAM™ covers

 Shock pump

 2 pair urethane tendons

 X/CLIPs™ with removable hardware

 Easy hinged lower tendon clamp with locking system

 6061-T CNC three (3) position X/CAMs™ with removable hardware

 2 pair urethane lower frame tendon guide wheels for sport configuration

 2 pair urethane lower frame bumper stops for ambulation configuration

 Tendon connector placement template

 User manual

Note: Consumable Products: The following items are classified as “Consumable Products” and will require

replacement when visual wear, cracks or tears are present. See “Periodic Maintenance Table” (Pages 20-22)

 Urethane tendons

 “VED” dampening bumpers

 Protective cover

 Crossflex™ inter-changeable preflexion wedges

Note: Available additional items NOT included in the Crossover™ kit:

 Crossflex™ adjustable preflexion wedges are available for purchase in a three (3) pack kit

(PN: C113)

 85 durometer “VED” bumper set

Ambulation

 Walking and community ambulation.

Winter Sports

 Alpine skiing

 Telemark skiing

 Cross country skiing

 Snowboarding

 Snow shoeing

 Ice Skating

 Hockey

 Snow kiting

Water Sports

 Water skiing

 Wakeboarding

 Wind surfing

 Surfing

 SUP

 Kite boarding

 Scuba diving

 Rowing / crewing

 Swimming

Summer Sports

 Mountain biking

 Road cycling

 Skate boarding

 Inline skating

 Backpacking

 Fighting sports

 Hiking

 Golf

 Beach days

Moto Sports

 Moto-cross

 Enduro and trail

 Motorcycle ADV

 Snowmobile

Rehabilitation

 Build muscle

 Weight lifting / squatting

 Promote general fitness

 Increase active, quality time with family

Compatible Activities, Sports and Rehabilitation

New Features and Benefits

 8° - 140° expanded range of USABLE flexion

 No fade after 90° degrees flexion

 New compact, lighter, stronger and 5cm (2”) shorter frame

 Easy removable hinged lower tendon connector with lock (no need to remove feet)

 ABS impact covers for sport and ambulation

 Multi-durometer Variable Extension Dampening “VED” bumper system

 Kneeling pad

 3ea Crossflex™ adjustable pre-flexion position wedges

 Oilite™ bushings that require no service

 Demo/trial program

Technical Specifications

 Maximum weight 125kg (275lbs)

 Net weight 908g (2lbs)

 Frame size 20cm (8 inches)

 8° to 150° knee flexion available range

Understanding the Crossover™ Knee System

Ambulation Configuration

 In the ambulation configuration the Crossover™ knee functions like a monocentric (single axis) S-N-S

knee unit, with a free swing feature utilizing a pneumatic/hydraulic shock with micro adjustment capabili-

ties and a unique “VED” impact multi-durometer inter-changeable bumper system to address swing and

stance gait phases.

 Under normal ambulation conditions no tendons and X/CAMs™ are used. However, the tendon and X/

CAM™ system may be used for highly active walking situations like—for example—back packing or hik-

ing.

 The Crossover™ knee utilizes a highly adjustable pneumatic/hydraulic cylinder to control flexion and ex-

tension adjustments.

 Variable Extension Dampening “VED” bumper system is also used to address stance phase.

Sport Configuration

 In the sport configuration the Crossover™ knee functions the same as in the ambulation noted above.

But, when combined with the relatively linear spring rate of the tendons and X/CAM™ system the Crosso-

ver™ delivers a smooth even energy absorption and return. It is this smooth isotonic stability that makes

the Crossover™ knee such a good choice for rehab and sport applications.

 Under sporting conditions, the tendon and X/CAM™ system are generally used. This system takes a user

about 3 minutes to add to the knee.

 Crossflex™ adjustable preflexion wedges may also be used to position the user into a more preflexed po-

sition. For example, snowboarding uses a 30° preflexion position.

 In general more air is added to the shock during heavy sport activities in combination with the tendon and

X/CAM™ system.

Ambulation Sport

Tendons

The tendon system is the heart of the Crossover™ knee, offering a highly var-

iable and infinitely tunable resistance and return mechanism. This relatively

linear spring rate of tendons and X/CAM™ system delivers a smooth, even

energy absorption and return. This patented tendon and X/CAM™ system is

what makes it possible for the user to get extension/resistance moments that

provide the needed assistance to enable exiting and absorbing the extreme

flexion moments associated with sport activities.

 This system is comprised of four primary components: tendons, tendon

connectors, three (3) position X/CAM™ guide wheels, and lower tendon

connector.

 Only one tendon durometer is needed with the Crossover™ knee.

 One OR two tendons may be used at a time.

 The primary goal in setting selections is to find the winning combination

that provides the optimal flexion resistance and extension assistance that

will balance forces like a natural leg for the activity the user is doing. The

idea is: “helping, but not hindering.”

Upper Tendon Connectors

The carbon tendon connectors form the proximal connection between the

socket and the tendon system. These connectors form the pocket that the flat-

tened ball end of the tendon slips into.

 They are connected with removable hardware or they can be bonded to

the socket.

 Optimal location is between 5” to 9” proximal of knee center.

 Ensure the tendon has a clear path on the socket to the tendon guide

wheel.

How the Systems Work Together

Lower Tendon Connector

The lower tendon connector is the distal attachment point for the ball

end of the tendon.

This connector can slide up or down the pylon, and is used as addition-

al adjustment for the tendons sliding distally to increase tension and

proximally to reduce tension. The lower connector that comes in the kit

is a designed to fit a 30mm pylon and is hinged for easy on and off.

X/CAM™ Guide Wheels

To enhance the fluid dynamic feel of the tendons a three (3) position

tendon X/CAM™ Guide Wheel system is used in conjunction with the

tendons at the knee axis. These X/CAMs™ allow the highest tuning of

tendon response within further progression of knee flexion.

Having a tendon resistance properly tuned within a specific range of

flexion is very important as it means the user can tune specific points

in flexion for the tendon to CAM into action, offering additional support

where it’s need it, or X/CAM™ out the energy for explosive returns.

Because of this X/CAM™ action Crossover™ users also achieve

much lower preflexion resistance allowing them to conserve much

needed energy while still providing the power and support needed

flexing 25 degrees and beyond.

Each X/CAM™ offers three levels of progression and an additional 4th

non-pinned option on each side, and can be used with the Crosso-

ver™ tendons in singles or pairs. These selections offer an unsur-

passed series of options within the full range of flexion that can all be

done on-the-fly without tools. The X/CAMs™ can also be utilized in

reverse (4th option) or in a non-pinned free movement position deliver-

ing the identical performance of the previous BTK model with a round

guide wheel.

 Pos.1 (single dot): This position is suggested for the least amount of X/

CAM™ effect with knee flexion (least amount of resistance).

 Pos.2 (two dots): This position is suggested for a mid-range of X/CAM™

effect with knee flexion (middle range of resistance).

 Pos.3 (three dots): This position is suggested for a maximum X/CAM™

effect with knee flexion (maximum range of resistance).

 Pos.4 (no locking pin): In this position the X/CAM™ is in a FREE motion

state with no increased resistance. This position is suggested if the

amount of flexion tension with the tendon is desired in the very least

amount of tension as the X/CAM™ will not engage during knee flexion.

RT3 Shock

The Crossover™ knee utilizes a pneumatic/hydraulic shock. This

shock uses a combination of air, oil and valving to control and change

flexion and extension moments. Air pressure is user adjustable and

the regulated air spring/air pressure will dictate how firm that spring is.

The user controls will regulate flexion and extension rates.

Similar in function to the S-N-S Mauch units this pneumatic/hydraulic

shock provides the ability to manage average ambulation require-

ments, and when combined with the tendon, X/CAM™ and Cross-

flex™ wedges (see below), provides the additional dampening and

rebound for high activity sports.

Crossflex™ Wedges

Crossflex™ preflexion wedges are a mid-durometer foam wedge sys-

tem that is user added to change the preflexion angle/position per

sport activity. Different sports require different preflexion settings.

Snowboarding for example may require 30° whereas mountain biking

may do better at 10°.

Crossflex™ wedges are designed to act like knee cartilage and pro-

vide a small amount of compression absorption. This feature absorbs

a small percentage of impact energy keeping it from directly translating

into the prosthetic limb. The net result is a less stressed prosthetic

limb.

Crossflex™ wedges require no tools to add to the knee and are insert-

ed at the knee axis.

20, 30 and 40 degree angle/positions are available. Note: When

standing forces are placed on the wedges, there is an average com-

pression rate of 5 to 10% to the wedges.

Variable Extension Dampening “VED” Bumper System

VED bumpers come in 75° and 85° durometer ratings and can be in-

terchanged to address knee performance during stance phase. 85 du-

rometer VED pads can be ordered separately. ( Page 26)

Alignment and Initial Ambulation Settings

This procedure addresses both ambulation and sport

When setting up the Crossover™ knee for the first time on a new patient, the goal is to align the knee in a sta-

ble condition for ambulation. All adjustments to tune the knee are after the patient is set in a stable alignment.

Make sure the patient is in parallel bars for safety as the knee will be in free swing with no or very little re-

sistance in the initial set up phase.

1. Unpack the box and make sure all items are in the package.

2. Remove air cap on shock and remove any residual air pressure. Depress valve to remove air.

(Figure 1)

3. Set all shock settings to the zero position. (Page 11-12)

4. Remove protective covers for easy adjustments.

5. Attach Crossover™ to prosthetic.

6. For recommended beginning alignment. (Figure 2)

Warning! If the patient is not stable they can fall at this stage of the fitting.

Figure 1

Figure 2

Alignment & First Time Set-Up

The alignment reference line is equal to the weight line

1. Alignment Reference Line (Socket Bisection)

2. Knee Axis Reference Point

•Establish a vertical pylon.

•Establish the knee center height.

•Establish the appropriate socket angles. 5 degrees of socket flexion is

recommended.

•Position the socket so that the alignment reference line bisects the

lateral wall at the ischial level of the socket and falls through or

slightly posterior to the knee axis.

•Establish the correct length of the prosthesis.

If the weight line is too far anterior to the knee axis, the knee may require much more effort to create a

hyperextension moment that will engage the knee axis and allow for fluid initiation of the knee flexion.

Premature knee flexion may result from a weight line position too posterior to the knee axis and will

make the knee unstable.

Figure 2 Figure 2/A

Figure 2/A displays alignment with a

socket flexed at10 degrees.

Understanding Shock Controls

Flexion Resistance—Blue Lever

This lever controls flexion, also known as “dampening” on this shock. The flexion lever has three positions.

Looking at the shock in the knee frame, these positions are 10, 2 and 6 O’clock.

On the shock these positions are labeled as the following: (Figure 3)

 10 O’clock = Unlock

 2 O’clock = Pedal

 6 O’clock = Lock

Figure 3

Most common setting for ambulation:

 10 O’clock position = Lowest flexion resistance. “Unlock” (Figure 4)

Additional settings most commonly used to address ambulation on un-

even terrain, stairs and steep declines:

 2 O’clock position = Medium flexion resistance. “Pedal” (Figure 5)

 6 O’clock position = Highest flexion resistance. “Lock”

(Figure 6)

Figure 4

Figure 6

Figure 5

Note: With higher air pressures the 6 O’clock setting can act as an on demand extension lock.

Extension Resistance—Red Dial

This red dial controls extension, also known as “rebound” on this shock. The red dial is located directly be-

hind the blue flexion lever. The red extension dial has a BLACK notch on it to indicate its position.(Figure

 The dial rebound adjuster has ten positions with audible/tactile clicks

 Clockwise rotation = slow extension (rebound)

 Counter-clockwise rotation = faster extension (rebound)

Air Pressure:

Air pressure influences flexion and extension based on the amount of air pressure added to the shock.

 High air pressures create more resistance and are better for heavy impact sport.

 Lower air pressures create less resistance and are better for walking.

 You can run 1psi to 275psi depending on the user’s requirements and the activity.

Figure 7

Walking the Patient and Adjusting the Shock

Step 1.

Set the shock to the zero set point.

 Set the Blue Lever to the 10 O’ Clock position.

 Turn the Red Dial in a clockwise rotation until it stops.

 Remove all the air from the shock.

 Remove air cap and depress the valve with a tool.

Step 2.

Set shock to “Recommended Home Position.” This is your starting position for each change in air pres-

sure.

 Blue Lever set to the 10 O’ Clock position.

 Turn Red Dial (4) clicks counter clockwise. The black notch should be at the 7 O’ Clock posi-

tion.

 Add 10 psi to the shock using the supplied shock pump.

Step 3.

 With the knee set at “Home Position” have the patient walk a few times in the parallel bars.

They should feel a slight resistance in the shock. This is a good starting point for ambulation

tuning.

 The first adjustment to address is extension. Adjust the red dial either COUNTER-

CLOCKWISE (faster extension) or CLOCKWISE (slower extension) from the original 7 O’clock

home position. Find the desired extension speed of the knee while walking the patient in the

parallel bars. Move the dial one click at a time faster or slower as it may only take one click

either way to find the desired settings.

 The second adjustment should be to flexion by adjusting the Blue Lever into one of three posi-

tion options on the shock.

 The patient should be at an air pressure range that they can walk with while the Blue Lever is

in the 10 O’clock position. (labeled as “Unlock” on the shock)

Warning! If the patient is not stable they can fall at this stage of the fitting.

Note: Keep notes on settings while working through adjustments. (Page 26)

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