PROTEOR ROG2 Rush Rogue 2 Foot Instruction Manual

: October 27, 2023
: PROTEOR

Table of Contents

INCLUDED ITEMS
**DESCRIPTION AND PROPERTIES
CLINICAL BENEFITS
ACCESSORIES AND COMPATIBILITIES
ASSEMBLY AND PATIENT FITTING
DETECTION OF MALFUNCTIONS
WARNINGS, CONTRAINDICATIONS, AND SIDE EFFECTS
MAINTENANCE, STORAGE, DISPOSAL, AND DURABILITY
DESCRIPTION OF SYMBOLS
REGULATORY INFORMATION
Documents / Resources

RUSH ROGUE® 2 by PROTEOR
ROG2 / EVQR2 / H2R2
Instruction for use RUSH ROGUE® 2 by PROTEOR
Prosthetist Instructions for use
Read before use Pass on § 3,7,8, and 9 of these instructions to the Patient.

INCLUDED ITEMS

RUSH ROGUE 2 FOOT

**DESCRIPTION AND PROPERTIES

**

A. Description
The RUSH ROGUE 2 is a responsive prosthetic foot made of glass composite material that delivers a dynamic high energy return with vertical compression and torsional rotation.
The RUSH ROGUE 2 EVAQ8 incorporates an elevated vacuum system.
The RUSH ROGUE 2 H2O incorporates an integrated Vibram® sole and custom molded rubber toe-wrap for superior traction on slick surfaces.
B. Properties

RUSH ROGUE 2	FOOT MODULE	EVAQ8	H2O*
Weight	1039g / 2.29 lbs	1048g / 2.31 lbs	883g / 1.96 lbs

Build
Height| 22 — 24cm| 6.1257155mm| 6.1257155mm| 5.6257142mm
25 — 27cm| 6.625″/168mm| 6.625″/168mm| 6.0007152mm
28 — 29cm| 6.7507171mm| 6.7507171mm| 6.5007165mm
Heel Rise| 3/8″/ 10mm
Weight based on a size 26cm, Cat 4 Foot Module with Foot Shell and Spectra Sock.
Build height based on 23cm, 26cm or 29cm, Cat 4 Foot Module with Foot Shell, Spectra Sock, and 10mm heel rise.
*H2O weight and build height does not include Foot Shell or Spectra Sock
Category Selection Guide

Weight| lb| 0-105| 106-140| 141-175| 176-210| 211-245| 246-280| 281-315| 316-350| 351-365
kg| 0-48| 49-64| 65-79| 80-95| 96-111| 112-127| 128-143| 144-159| 160-166
Activity
Level| Low| 1| 2| 3| 4| 5| 6| 7| 8| 9
Moderate| 1| 2| 3| 4| 5| 6| 7| 8| 9
High| 1| 2| 3| 4| 5| 6| 7| 8| 9
High Impact| 2| 3| 4| 5| 6| 7| 8| 9|

INTENDED USE/INDICATIONS
This medical device is supplied to healthcare professionals (prosthetists) who will train the patient in its use. The prescription is made by a doctor together with the prosthetist, who assess the patient’s ability to use it.
This device is for SINGLE PATIENT use. It should not be reused on another patient.
INSTRUCTIONS FOR USE
This device is intended for use by prosthesis wearers who would benefit from the smooth rollover, dynamic toe response, vertical compression, and torsional rotation. Users should meet the requirements of a Medicare functional level of K3 or higher.
This device is indicated for use as a component in a prosthetic leg for individuals with unilateral or bilateral lower-limb amputations or limb deficiencies, including:

Transstadial amputation
Transfemoral amputation
Knee disarticulation amputation
Hip disarticulation amputation
Congenital, lower-limb deficiencies

Maximum weight (load carrying included): See above table

CLINICAL BENEFITS

The device provides clinical benefits and performance including:

Ability to ambulate on variable terrain
Shock absorption
Axial rotation
Reduced socket forces and increased comfort

ACCESSORIES AND COMPATIBILITIES

The foot incorporates a male pyramid link that allows it to be used with female pyramid connectors (refer to our catalog).

ASSEMBLY AND PATIENT FITTING

A. Assembly
RUSH ROGUE 2 Foot:
The foot module is pre-assembled consisting of fiberglass components (an upper blade and a continuous lower blade), rubber heel shock bumper, a Spectra sock, and a foot shell, and a heel wedge to adjust heel stiffness.
RUSH ROGUE 2 EVAQ8:
The foot module is pre-assembled consisting of fiberglass components (an upper blade and a continuous lower blade), RUSH Foot EVAQ8 system inside the rubber heel shock bumper, Spectra sock, foot shell, and heel wedge to adjust heel stiffness.
The straight barb, exhaust filter, tubing, inline filter, socket right angle barb and housing, tube securing hook and loop tape are included with the foot and will require assembly prior to use.
To connect the vacuum system to the socket:
A. Connect a short piece of the tubing to the socket right angle barb.
B. Install the inline filter into the distal end of the tubing (the inline filter may be placed anywhere in the tubing run between the socket and vacuum pump heel).
C. Connect a second piece of tubing to the distal end of the inline filter and route the tube to the medial side of the pylon or wrap the tubing around the pylon (to prevent damage to the tube or snagging while walking).
D. Cut the tubing to desired length and connect to the straight barb located in the recessed area of the vacuum pump heel.
E. Secure the tubing to the pylon using the included hook and loop tape or other appropriate tape.

RUSH ROGUE 2 H2O:
The foot module is pre-assembled consisting of fiberglass components (an upper blade and a continuous lower blade), rubber heel shock bumper, and Vibram Sole.
After dynamic alignment, torque pyramid adjustment screws to the manufacturer’s specifications. Secure pyramid adjustment screws with thread locking adhesive (e.g., Loctite 242).
B. Spectra Socks
A Spectra sock is provided to minimize noise and protect the foot shell/fiberglass components. The Spectra sock should be placed over the keel and the sole plates before donning the foot shell. Spectra socks must be replaced at intervals appropriate to the user’s activity level. Failure to inspect and replace the Spectra socks may prematurely wear the foot module and will void the warranty.
The RUSH ROGUE 2 H2O should not be worn with a Foot Shell; therefore, does not include a Spectra Sock.
C. Foot Shell
When removing or installing the foot shell, always use an appropriate tool or device to minimize wear and damage, such as a shoehorn.
Do not attempt to remove the foot from its shell by pulling out by hand. This may damage the foot, voiding the warranty.
The RUSH ROGUE 2 H2O is not intended to be worn with a foot shell; doing so may damage the foot module.
D. Bench Alignment
Recommendation: Add a 3/8” wedge under back of the foot during bench alignment.
Sagittal Plane:
After determining the appropriate socket flexion and heel height, position the weight line so that it falls through the center of the foot adapter. As the unique glass composite material provides substantially more flexibility than the other prosthetic feet, this represents a good starting point for a bench alignment.
Coronal Plane:
After determining the appropriate socket adduction/abduction, position the weight line so that it falls through the midline of the foot in a neutral M-L position.

RUSH ROGUE 2 FOOT &
RUSH ROGUE 2 EVAQ8| RUSH ROGUE 2 H2O
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|

E. Static Alignment
Due to the shape of the rocker sole (bottom blade), patients may experience a new sensation when seeking the midpoint of the foot.
The rocker sole allows patients to find their own comfortable static or standing position. The rocker bottom shape of the sole serves 2 primary functions:
a. Provide a continuous and progressive point of contact throughout the entire step.
b. Eliminate any “flat” or “dead” spot.
The Prosthetist is highly discouraged from introducing wedges at this stage of alignment.
Adjustment of the A/P set screws at the proximal adapter is the more appropriate place to make changes regarding plantar flexion or dorsiflexion, rather than the introduction of a wedge.
F. Dynamic Alignment:
The use of a slide adapter is highly encouraged for dynamic alignment purposes, as it provides the best solution to troubleshooting the most common alignment issues listed below:
a. Hard or soft heel
b. Hard or soft toe
c. Varus or Valgus movements during Stance Phase
Once the optimal relative socket/foot alignment is determined, it is encouraged to use plantarflexion or dorsiflexion at the proximal foot adapter to optimize heel-to-toe comfort and energy return.
For RUSH ROGUE 2 Foot and RUSH ROGUE 2 EVAQ8:
If the patient still requests additional heel stiffness, it is appropriate to introduce and utilize the Heel Wedge provided in the original RUSH ROGUE 2 and RUSH ROGUE 2 EVAQ8 package.
This Heel Wedge uses a double-sided sticker so the lower face of the blade should be degreased before using. See figures below for correct wedge placement.
NOTE: The RUSH ROGUE 2 H2O does not include Heel Wedges.

CORRECT HEEL WEDGE PLACEMENT	INCORRECT HEEL WEDGE PLACEMENT

Install Heel Wedge on plantar surface of rocker approximately 1/8” (3.2mm) forward from posterior end.| Placement between components will adversely affect foot performance and void warranty.

DETECTION OF MALFUNCTIONS

If you notice any abnormal behavior or feel any changes in the characteristics of the device, or if the device has received a severe impact, consult your prosthetist.

WARNINGS, CONTRAINDICATIONS, AND SIDE EFFECTS

A. Warnings
Inappropriate use of the device, in relation to the recommendations of your prosthetist, can cause the degradation of parts of the foot (carrying heavy loads for example, excessive stress, exceeding the service life, etc.)
Waterproof: The device is resistant to fresh, sea, and chlorinated water.
B. Contraindications
The device is inappropriate for users who do not meet the requirements of a Medicare functional level of K3 or higher.
This device is not intended for activities where there is a risk of severe impact or excessive overload.
C. Side effects
There are no known negative side effects.
Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority.

MAINTENANCE, STORAGE, DISPOSAL, AND DURABILITY

A. Maintenance/ Cleaning:
No maintenance operation such as lubrication, work on the screws, or other parts is required.
Inspect the foot module every six months. If the user is more active, more frequent inspection may be necessary. Service as necessary.
The foot module may be cleaned and/or disinfected with soap and warm water.
For options with a foot shell:
Do not allow aggregates such as sand to remain in the foot shell. Upon exposure to aggregates, immediately disassemble prosthesis by removing the foot shell from the foot and rinse with water. The abrasive properties of aggregates will wear the fiberglass components of the foot module.
After use in water:

Remove the foot shell and take off the sock
Rinse the foot with clean water
Dry well

Replace sock and/or foot shell if worn to prevent damage to the fiberglass components.
The RUSH FOOT EVAQ8 Collection components may need periodic cleaning or replacement during the life cycle of the system and are not replaceable under the warranty as it is considered normal wear:

Tubing
Inline filter
One-way valves housed inside the vacuum heel

B. Periodic Inspection of the RUSH ROGUE 2 EVAQ8 System:

Inspect the foot module every six months. If the user is more active, more frequent inspection may be necessary. Service as necessary.
Visually inspect the tubing for kinks, cracks, or wear that may leak air into the system. Replace tubing if any of these conditions exist.
Remove the inline filter from tubing and look through it. If light can be seen, the filter is clean. If light is blocked, blast air from a syringe through the inline filter from distal to proximal end (reverse of normal flow) to attempt to clear the blockage. If blockage persists, the filter needs to be replaced.
The one-way valves contained in the vacuum heel may need to be cleaned and flushed with distilled water or isopropyl alcohol to ensure proper function. This procedure should be done only by a qualified professional.
To flush the one-way valves and vacuum heel:

| |
---|---|---
1. Exhaust Assembly
2. Exhaust Filter
3. Large O-Ring
4. Valve Body Adapter
5. Small O-Ring| 2. Exhaust Filter
6. Duckbill Valve| 7. Straight Barb
| |
8. Duckbill Valve| 9. Paperclip (foot on side)| 9. Paperclip (foot upright)

Remove the vacuum hose from the user’s socket keeping it attached to the EVAQ8 foot.
Remove the EVAQ8 foot from the user’s socket.
Remove the vacuum hose from the EVAQ8 foot.
Using a 5⁄16” socket, remove the (1) Exhaust Assembly from the heel, the (4) Valve Body Adapter will most likely stay attached to the (2) Exhaust Filter. NOTE: If (4) Valve Body Adapter does not remove with (2) Exhaust Filter, use a flat blade screwdriver to remove it.
Place the (4) Valve Body Adapter into a soft jaw vice or grip with soft face pliers and remove the (2) Exhaust Filter with 5⁄16” socket. NOTE: (6) Duckbill Valve will be slightly pressed into the bottom of the exhaust filter.
Using a 1⁄4” deep socket, remove the (7) Straight Barb from the other side of the heel.
Inside the heel beneath where the (7) Straight Barb was located is another (8) Duckbill Valve. Remove the (8) Duckbill Valve by tapping the foot against your hand or by straightening out a (9) Paperclip and inserting it into the other side of the heel to push out the (8) Duckbill Valve.
Inspect both (3 & 5) O-rings on the (4) Valve Body Adapter. There is one at the base of the threads, and one in a groove on the body. Replace both if they show any wear.
Clean the female threads in both sides of the heel with a cotton swab and isopropyl alcohol or distilled water.
If you are reusing the (1) Exhaust Filter, (7) Straight Barb, in-line filter, and (8) Duckbill Valve, clean them with isopropyl alcohol or distilled water. Take extra care and make sure the (8) Duckbill Valve are clean and free from debris (a magnifier is helpful for inspection). Flush the in-line filter from both directions to ensure it is clean.
Once the parts are dry, or if you are using new parts from a rebuild kit, set all the parts out on a clean surface.
Insert the turquoise (8) Duckbill Valve into the threaded opening of the (1) Exhaust Filter so that the (8) Duckbill Valve rim is flush against the opening of the (1) Exhaust Filter and the tip of the (8) Duckbill Valve is inside the (1) Exhaust Filter. Thread the (1) Exhaust Filter into the (4) Valve Body Adapter BY HAND until snug.
13. BY HAND, thread the assembled (1) Exhaust Assembly into side of the heel that will NOT be connected to the prosthetic socket by vacuum hose.
Once the (1) Exhaust Assembly is threaded in snugly BY HAND, torque to 15 in-lbs. Do not over torque. Over torqueing will snap the threads and will not be covered under warranty. NOTE: If you do not have a torque wrench, thread the (1) Exhaust Assembly until you feel a hard stop and then turn 1⁄16 of a revolution more.
Insert the white (8) Duckbill Valve into the recessed side of the heel so the tip of the (8) Duckbill Valve points into the heel. Using a small screwdriver or a straightened-out (9) paperclip, make sure the (8) Duckbill Valve is seated all the way into the recess.
BY HAND, thread the (7) Straight Barb into the side of the heel that is recessed.
Once the (7) Straight Barb is threaded in snugly BY HAND, torque it to 15 in-lbf. This is a very low torque value, and over torquing will snap the threads on the (7) Straight Barb and will not be covered under warranty.
If you do not have a torque wrench, thread the (7) Straight Barb until you feel a hard stop and then turn 1⁄16 of a revolution more.
Reattach vacuum hose to EVAQ8 foot by sliding the vacuum hose over the (7) Straight Barb.
Put the Spectra Sock and foot shell over the EVAQ8 foot.
Reattach the EVAQ8 foot to the user’s socket.
Reattach the other end of the vacuum hose to the user’s socket. The vacuum hose may be routed to the prosthetist’s preference.

B. Storage
Operating & Storage Temperatures Range: -20 to 60° C [-4 to 140° F] Storage and operating relative humidity range: No restrictions
C. Disposal
The different items of the foot are special wastes and must be handled according to local laws.
D. Durability
Purchase of the RUSH ROGUE 2 includes a 36-month warranty covering all manufacturer defects effective only if the product is used according to manufacturer recommendations. The foot shell is covered for 6 months.