ottobock F21 Maverick Xtreme AT Instruction Manual

F21 Maverick Xtreme AT
F22 Maverick Comfort AT

F21 Maverick Xtreme AT

Heel wedge position (distance to the end of the spring)

Size of the foot (cm)| Distance (mm)
23 to 25| 41
26 to 28| 51
29 to 30| 57

Product description

INFORMATION
Date of last update: 2021-10-13
► Please read this document carefully before using the product and observe the safety notices.
► Instruct the user in the safe use of the product.
► Please contact the manufacturer if you have questions about the product or in case of problems.
► Report each serious incident related to the product to the manufacturer and to the relevant authority in your country. This is particularly import­ ant when there is a decline in the health state.
► Please keep this document for your records.
1.1 Construction and Function
This document applies to the following products: F21 Maverick Xtreme AT, F22 Maverick Comfort AT
The prosthetic foot has fibreglass spring elements. The heel stiffness can be increased with heel wedges.
1.2 Combination possibilities
This prosthetic component is compatible with Ottobock’s system of modular connectors. Functionality with components of other manufacturers that have compatible modular connectors has not been tested.
Limited combination options for Ottobock components The prosthetic foot generates high moments in the ankle area. Use structural components with higher weight limits:

Intended use

2.1 Indications for use
The product is intended exclusively for lower limb exoprosthetic fittings.
2.2 Area of application
Our components perform optimally when paired with appropriate compon­ ents based upon weight and mobility grades identifiable by our MOBIS clas­ sification information and which have appropriate modular connectors.
Maverick Xtreme AT
The product is recommended for mobility grade 3 (unrestricted outdoor walker) and mobility grade 4 (unrestricted outdoor walk­ er with particularly high demands).

Maverick Comfort AT
The product is recommended for mobility grade 2 (restricted outdoor walker) and mobility grade 3 (unrestricted outdoor walk­ er).
The table that follows shows the suitable spring stiffness of the prosthetic foot, matching the patient’s body weight and activity.

Spring stiffness relative to body weight and activity level

Body weight [kg]| Low| Normal| High
44 to 52| 1| 1| 2
53 to 59| 1| 2| 3
60 to 68| 2| 3| 4
69 to 77| 3| 4| 5
78 to 88| 4| 5| 6
89 to 100| 5| 6| 7
101 to 116| 6| 7| 8
117 to 130| 7| 8| 9
131 to 147| 8| 9| –
148 to 166| 9| –| –

2.3 Environmental conditions
Storage and transport
Temperature range –20 °C to +60 °C (–4 °F to +140 °F), relative humidity 20 % to 90 %, no mechanical vibrations or impacts
Allowable environmental conditions
Temperature range: –10 °C to +45 °C (14 °F to 113 °F)
Chemicals/liquids: fresh water, salt water, perspiration, urine, soapsuds, chlorine water
Moisture: Submersion: max. 1 h in 3 m depth, relative humidity: no restrictions Solids: Dust, occasional contact with sand.
Clean the product after contact with humidity/chemicals/solids, in order to avoid increased wear and damage (see page 21).
Unallowable environmental conditions
Solids: Highly hygroscopic particles (e.g. talcum), continuous contact with sand Chemicals/liquids: Acids, continuous use in liquid media
2.4 Lifetime
Prosthetic foot
Depending on the patient’s activity level, the maximum lifetime of the product is 3 years.
Footshell, protective sock
The product is a wear part, which means it is subject to normal wear and tear.

Safety

3.1 Explanation of warning symbols

CAUTION Warning regarding possible risks of accident or injury.
NOTICE Warning regarding possible technical damage.
3.2 General safety instructions
CAUTION!
Risk of injury and risk of product damage
► Note the combination possibilities/combination exclusions in the instruc­ tions for use of the products.
► Comply with the product’s field of application and do not expose it to excessive strain (see page 15).
► To avoid the risk of injury and product damage, do not use the product beyond the tested lifetime.
► To avoid the risk of injury and product damage, only use the product for a single patient.
► To prevent mechanical damage, use caution when working with the product.
► If you suspect the product is damaged, check it for proper function and readiness for use.
► Do not use the product if its functionality is restricted. Take suitable measures (e.g. cleaning, repair, replacement, inspection by the manu­ facturer or a specialist workshop).
NOTICE!
Risk of product damage and limited functionality
► Check the product for damage and readiness for use prior to each use.
► Do not use the product if its functionality is restricted. Take suitable measures (e.g. cleaning, repair, replacement, inspection by the manu­ facturer or a specialist workshop).
► Do not expose the product to prohibited environmental conditions.
► Check the product for damage if it has been exposed to prohibited envir­ onmental conditions.
► Do not use the product if it is damaged or in a questionable condition.
Take suitable measures (e.g. cleaning, repair, replacement, inspection by the manufacturer or a specialist workshop).
Signs of changes in or loss of functionality during use
Reduced spring effect (e.g. decreased forefoot resistance or changed rollover behaviour) or delamination of the spring are indications of loss of functionality. Unusual noises can indicate a loss of functionality.

Scope of delivery

Additional accessories/spare parts (not included in the scope of delivery)

Designation| Reference number
Footshell (without cap)| FTC-3A-1
Footshell with sandal toe (without cap)| FTC-2A-1
Tool to change the footshell| ACC-00-10300-00
Protective sock (white)| SL=Spectra-Sock

Preparing the product for use

CAUTION
Incorrect alignment, assembly or adjustment
Injury due to incorrectly installed or adjusted as well as damaged prosthet­ ic components
► Observe the alignment, assembly and adjustment instructions.

NOTICE
Grinding the prosthetic foot or footshell
Premature wear resulting from damage to the product
► Do not grind the prosthetic foot or footshell.
5.1 Alignment
INFORMATION
There is a plastic protector on the product’s pyramid. It protects the con­ necting section from scratches during the alignment and fitting of the pros­ thesis.
► Remove the protector before the patient leaves the workshop/fitting area.
5.1.1 Applying/removing the footshell
INFORMATION
► Pull the protective sock over the prosthetic foot to prevent noises in the footshell.
► Always use the prosthetic foot with the footshell.
► Apply or remove the footshell as described in the footshell instructions for use.
5.1.2 Bench Alignment
TT bench alignment

Bench alignment process

Required materials: 662M4 goniometer, 743512 heel height measuring device, 743A80 50:50 gauge, alignment tool (e.g. 743L200 L.A.S.A.R. Assembly or 743A200 PROS.A. Assembly)
Assemble and align the prosthetic components in the alignment apparatus according to the following specifications:
1| Dorsiflexion/plantar flexion: Adjust the prosthetic foot to the heel height of the shoe. (The prosthetic foot is designed for shoes with a heel height of 10 mm.)
2| Adduction/abduction: Adjust the angle of the prosthetic socket in the frontal plane.
3| Flexion/extension: Adjust the angle of the prosthetic socket in the sagittal plane.
4| Linear shifting of the prosthetic socket: Shift the prosthetic socket so that the plumb line runs along the front edge of the adapter on the prosthetic foot (see fig. 3).

TF bench alignment
► Observe the information in the prosthetic knee joint instructions for use.
5.1.3 Static Alignment

• Ottobock recommends checking the alignment of the prosthesis using the L.A.S.A.R. Posture and adapting it as needed.

5.1.4 Dynamic Trial Fitting

• Adapt the alignment of the prosthesis in the frontal plane and the sagittal plane (e.g. by making angle or slide adjustments) to ensure an optimum gait pattern.
• TT fittings: Make sure that physiological knee movement in the sagittal and frontal plane is achieved when the leg begins to bear weight after the heel strike. Avoid medial movement of the knee joint. If the knee joint moves in the medial direction in the first half of the stance phase, move the prosthetic foot in the medial direction. If the medial movement occurs in the second half of the stance phase, reduce the exterior rotation of the prosthetic foot.
• Remove the plastic protector from the pyramid after completing the dynamic fitting and the walking exercises.

Heel too soft

Symptoms| Possible solutions
• Foot makes full ground contact too quickly
• Forefoot feels too stiff
• Knee goes into hyperextension| • Shift prosthetic socket forward relative to the foot
• Use a heel wedge
Heel too hard

Symptoms| Possible solutions
• Fast knee flexion, low stability
• Transition from heel strike to toe-off too fast
• Energy return feels low| • Shift prosthetic socket back relative to the foot
• Reduce the heel stiffness (shift or remove heel wedge)
Prosthetic foot too stiff

Symptoms| Possible solutions
• Minimal rollover movement of the pros­ thetic foot at low walking speed (long full ground contact)| • Select prosthetic foot in lower stiffness
Prosthetic foot too soft

Symptoms| Possible solutions
• Clicking noise at the start of ground contact.| • Select prosthetic foot in higher stiff­ ness

Prosthetic foot too soft

• Very pronounced deformation of the forefoot at high activity levels

5.1.4.1 Optimising the heel characteristics
The behaviour of the prosthetic foot at heel strike and during heel contact in the mid-stance phase can be adapted with the placement of a heel wedge. The heel wedge is attached with adhesive tape for testing. For definitive assembly, it is glued to the prosthetic foot.
Fitting

1. Use the adhesive tape on the underside of the heel wedge.
2. Place the heel wedge on the base spring in the recommended position (Dummybild_klein2).
3. Set the desired stiffness by shifting the heel wedge (anterior = harder, posterior = softer).

Definitive assembly

1. Remove the adhesive tape from the heel wedge. This can be done using a cloth with acetone.
2. Roughen the contact surface on the prosthetic foot slightly using sand­ paper. Remove the dust after sanding.
3. Glue the heel wedge to the prosthetic foot with cyanoacrylate adhesive.

Cleaning

Allowable cleaning agent: pH neutral soap (e.g. 453H10 Derma Clean)

1. NOTICE! To avoid product damage, only use the allowable clean­ ing agents. Clean the product with clear fresh water and a pH neutral soap.
2. If present: Remove dirt from water drainage contours using a toothpick and rinse.
3. inse the soap away with clear fresh water. In doing so, rinse the foot­ shell until all dirt has been removed.
4. Dry the product with a soft cloth.
5. Allow to air dry in order to remove residual moisture.

Maintenance

► A visual inspection and functional test of the prosthetic components should be performed after the first 30 days of use.
► Inspect the entire prosthesis for wear during normal consultations.
► Inspect the product for visible damage every six months. Make additional inspection appointments as needed (e.g. for highly active or heavy users).

Disposal

In some jurisdictions it is not permissible to dispose of the product with unsorted household waste. Improper disposal can be harmful to health and the environment. Observe the information provided by the responsible authorities in your country regarding return, collection and disposal proced­ ures.

Legal information

All legal conditions are subject to the respective national laws of the country of use and may vary accordingly.
9.1 Liability
The manufacturer will only assume liability if the product is used in accord­ ance with the descriptions and instructions provided in this document. The manufacturer will not assume liability for damage caused by disregarding the information in this document, particularly due to improper use or unauthor­ ised modification of the product.
9.2 CE conformity
The product meets the requirements of Regulation (EU) 2017/745 on medic­ al devices. The CE declaration of conformity can be downloaded from the manufacturer’s website.

Technical data

F21 Maverick Xtreme AT

Sizes [cm]| 23| 24| 25| 26| 27| 28| 29| 30
Heel height [mm]| 10
System height [mm]| 144| 152| 165
Build height [mm]| 162| 170| 183
Average weight with footshell [g]| 646| 798| 891
Max. body weight [kg]| 166
Mobility grade| 3, 4
F22 Maverick Comfort AT

Sizes [cm]| 23| 24| 25| 26| 27| 28| 29| 30
Heel height [mm]| 10
System height [mm]| 98| 99| 101
Build height [mm]| 116| 117| 119
Average weight with footshell [g]| 626| 763| 841
Max. body weight [kg]| 166
Mobility grade| 2, 3

Ottobock SE & Co. KGaA
Max-Näder-Straße 15 · 37115 Duderstadt · Germany
T +49 5527 848-0 · F +49 5527 848-3360
healthcare@ottobock.de · www.ottobock.com
**** Otto Bock HealthCare LP
3820 West Great Lakes Drive
Salt Lake City, UT 84120 · USA
T +1 800 328 4058 · F +1 800 655 4963
© Ottobock · 647G1715=all_INT-03-2110

References

• Welcome to Ottobock

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