ottobock 17AD100 Tango Ankle Joint Instruction Manual

: June 3, 2024
: ottobock

ottobock 17AD100 Tango Ankle Joint

Foreword

INFORMATION

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 important when there is a decline in the health state.
Please keep this document for your records.

These instructions for use provide important information on the processing of the 17AD100* system ankle joint. A FIT-KIT, reference number 17AD100A=FIT-KIT, is available for the 17AD100 ankle joint.

Product Description

Available sizes

The size of the product is selected according to the planned use (unilateral or bilateral) and the body weight

	Maximum body weight in kg (lbs)
Unilateral use (lateral or medial)	**Bilateral use (lateral and

medial)*
17AD100=10| 15 (33)| 25 (55)
17AD100=12| 20 (44)| 40 (88)
17AD100=14| 50 (110)| 80 (176)
17AD100=16| 85 (187)| 120 (264.5)
17AD100=20| 110 (242.5)| 160 (352.5)

INFORMATION

Use the next larger size if the product is being worn unilaterally and in case of flexion contractures in the knee or hip >10°, distinct torsion or varus/valgus instabilities or increased physical activity.
Use the product bilaterally if there is an ischial support.

Components/design

see
fig. 1 , item| Quant ity| Designation| Reference number
---|---|---|---
| 1| Nexgear Tango ankle joint| 17AD100
| Consisting of:
1| 2| Blind caps|
2| 1| Basic piece|
3| 1| Joint nut| 17AD100S=
4| 1| Joint screw
5| 10| Axial washers| 17AD100S=-1
6| 1| Lamination dummy cover| 17AD100A=DY--P
9| 2| Countersunk head screws| 501S137=M4x8 (size 10, 12)
501S137=M4x10-2 (size 14)
501S137=M5x10-1 (size 16, 20)

Not included in scope of delivery

see fig. 1 , item| Quant ity| Designation| Reference number
7| 1| Foot stirrup| 17SF100=OS, 17SF101=OS
8| 1| Foot stirrup bearing bushing| 30Y306=10 (size 10)
30Y306=12 (size 12)
30Y306=14 (size 14)
30Y306=16 (size 16, 20)
10| 1| Lamination bar| 17LS3= (size 10, 12, 14, 16, 20)
| | Side bar| 17LV3=
see fig. 2 ,
item| Quant ity| Designation| Reference number
---|---|---|---
| 1| Lamination dummy set| 17AD100A=DY*
| Consisting of:|
1| 1| Lamination dummy – lower part|
2| 1| Lamination dummy – screw|
The cover for the lamination dummy (see fig. 1, item 6) is not included in the lamination dummy set.

see fig. 5 ,
item| Quant ity| Designation| Reference number
---|---|---|---
| 1| Nexgear Tango adjustable Stop-module| 17AD100A=AS
| Consisting of:
1| 1| Set screw| 30Y309= (size 10, 12, 14)

30Y309=20 (size 16, 20)

2| 1| Stop sleeve with internal bumper stop| 17AD100S=AS-*-1 (size 10, 12,

17AD100S=AS-20-1 (size 16, 20)

3| 1| Threaded hole with cover| 17AD100S=AS-*-2 (cover)

254521
3, item| Quant ity| Designation| Reference number
---|---|---|---
| 1| Nexgear Tango Spring-module| 17AD100A=LS
| Consisting of:
1| 1| Set screw| 30Y309= (size 10, 12, 14)

30Y309=20 (size 16, 20)

2| 1| Coil spring (sizes 10,12) Compression spring (sizes 14, 16, 20)| 17AD100S=LS--1
3| 1| Spring guide housing
4| 1| Ball
5| 1| Threaded hole with cover| 17AD100S=LS--2 (cover)
see fig. 7 , item| Quant ity| Designation|
---|---|---|---
| 1| Nexgear Tango Reaction- module|
| Consisting of:
see fig. 7 ,
item| Quant ity| Designation| Reference number
---|---|---|---
1| 1| Cover cap| 516K2=25-7 (size 10, 12)
516K2=30-7 (size 14, 16, 20)
2| 1| Spring bolt with O-ring| 17AD100S=HS--3 (size 10, 12,
14)
17AD100S=HS-20-1 (size 16, 20)
3| 1| Spring dummy|
5| 1| Spacer washer|
6| 1| Spring holder|
7| 1| Spring plunger|
8| 1| Bearing sleeve| 17AD100S=HS--1 (size 10, 12,
14)
17AD100S=HS-20-1 (size 16, 20)
9| 1| Support element| 30Y444=
=10/12/14 (size 10, 12, 14)
=20 (size 16, 20)
(Maintenance interval 1 year, then replace entirely)
10| 1| Stop pin| 17AD100S=HS--1
11| 1| Cover| 17AD100S=HS-*-2

Not included in scope of delivery

Required tools

The scope of delivery does NOT include:

Quantity| Designation| Reference number
1| Mounting adapter| 17AD100A=MA-10 (size 10)
17AD100A=MA-12 (size 12)
17AD100A=MA-14 (size 14)
17AD100A=MA-20 (size 16, 20)

Intended use

Indications for use

System ankle joints are intended to be used exclusively for providing a patient with a lower limb orthosis.
In case of unilateral use, the manufacturer recommends that the system ankle joint be processed by means of the lamination resin technique or carbon prepreg technology.

Indications

Partial or total paralysis of the leg muscles.
Indications must be determined by the physician.

Combination possibilities

Combination 17AD100 with 17B203 E-MAG Active
The 17AD100 Nexgear Tango orthotic ankle joint can be combined with the 17B203 E-MAG Active orthotic knee joint.

Combination possibilities

INFORMATION
Do not make any further static or dynamic changes to the 17AD100 after automatic calibration of the 17B203 E-MAG Active. If patient-specific adjustments to the 17AD100 are required, repeat the process steps for automatic calibration of the 17B203 E-MAG Active according to the 647G1165 instructions for use.

Further information about the processing of the 17B203* E-MAG Active is found in the 647G1165 instructions for use.

Lifetime

The product is designed for the following lifetime, given intended use and proper installation:
Joint sizes 10, 12: 1 year
Joint sizes 14, 16, 20: 3 years

Qualification

Patients may be fitted with the product only by trained qualified personnel. The qualified personnel must be familiar with the handling of the various techniques, materials, machines and tools.

Safety

Explanation of warning symbols

Warning regarding possible risks of accident or injury.

Warning regarding possible technical damage.

Safety instructions

Excessive strain on load-bearing components Injuries due to changes in or loss of functionality

Only use the product for the defined area of application.
If the product has been exposed to extreme strain (e.g. due to falling), take any necessary measures (e.g. repair, replacement, inspection by the manufacturer’s customer service, etc.).

Mechanical damage to the product Injuries due to changes in or loss of functionality

Use caution when working with the product.
Check the product for proper function and readiness for use.
In case of changes in or loss of functionality, discontinue use of the product and have it checked by authorized, qualified personnel.

Excessive strain due to use on more than one patient Risk of injury and loss of functionality as well as damage to the product

Use the product on only one patient.
Observe the maintenance recommendations.

Thermal overloading of the product Damage due to improper thermal treatment

Do not carry out any heat treatment at temperatures above 300 °C (570 °F).
Prior to thermal treatment, remove all temperature-critical components (such as plastic parts).

Thermal overloading of product components Loss of function due to improper thermal treatment

Prior to the thermal treatment of the product, remove all temperature critical components (e.g. plastic parts).

Exposure of the product to unsuitable environmental conditions Damage, brittleness or destruction due to improper handling

Avoid storage in condensing ambient humidity.
Avoid contact with abrasive substances (e.g. sand, dust).
Do not expose the product to temperatures below -10 °C (14 °F) or above +60 °C (140 °F) (e.g. sauna, excessive sunlight, drying on a radiator).

Preparing the product for use

Incorrect alignment, assembly or adjustment Risk of injury due to change in or loss of functionality

Assembly, adjustment and maintenance operations may only be completed by qualified personnel.
Observe the alignment, assembly and adjustment instructions.

Processing

Required materials: 17AD100A=DY lamination dummy set, 17AD100A=DY--P lamination dummy cover, 17LS3= lamination bar or 17LV3= side bar, 17SF100=OS/17SF101=OS foot stirrup, 501S137=* countersunk head screws, 743Y56=4 alignment insert, 636K8 Plastaband

The patient-specific plaster model has been fabricated

Use the screws (item 9) to mount the bar (see fig. 1, item 10) to the bottom section of the lamination dummy (see fig. 2, item 1).
Place the foot stirrup (item 7) with the bearing bushing (item 8) in the lamination dummy cover.
Set the cover onto the lower section of the lamination dummy and secure it with the lamination dummy screw (see fig. 2, item 2). Due to the design, the foot stirrup with the cover is brought to the neutral position.
Attach the lamination dummy to the plaster model by inserting the lamination dummy screw through the cover, foot stirrup and lower section and screwing it to the alignment insert.
Seal the screws of the bar and dummy with Plastaband.
Laminate the orthosis according to the patient’s needs.
After the laminate hardens, remove the laminated blank from the plaster model. To do so, expose the lamination dummy with a knife and remove it.
Remove the Plastaband from the screws.
Remove the two screws from the bar.
Loosen the lamination dummy screws and remove the cover.
Use the oscillating saw to expose the edges for removal.
Remove the components from the plaster.

Assembling the joint

Mounting the axial washers

Select and insert the axial washers (see the following table for the thickness of the axial washers).
Optimize the movement of the orthosis joint by replacing the axial washers step-by-step: Use thicker washers if there is play in the medial/lateral direction, thinner washers if there is resistance in plantar flexion/dorsal extension.

Orthosis joint size	Thickness of axial washers [mm]
17AD100=10, 17AD100=12	0.70, 0.75, 0.80, 0.85, 0.90

17AD100=14, 17AD100=16,
17AD100=20*| 0.85, 0.90, 0.95, 1.0, 1.05, 1.10

Mounting the foot stirrup

Check the position of the bearing bushing (see fig. 1, item 8) in the foot stirrup (item 7).
Place the basic piece of the joint (item 2) onto the foot stirrup with the axial washers (item 5) (see fig. 8). Insert one axial washer per side and ensure that the foot stirrup is centred.
Check whether the foot component can be moved smoothly and without play. Use axial washers of varying thicknesses if necessary.
Make sure that the axial washers prevent direct contact between the metal basic piece and the foot stirrup.
Insert the joint screw (item 4) and the joint nut (item 3) and secure the screw connection with Loctite 241 and the corresponding torque (see fig. 9). See the illustration of the ankle joint for the corresponding wrench sizes and tightening torque values (see fig. 1).

Mounting the bar

Fasten the bar to the basic piece using the countersunk head screws and secure the screw connections with Loctite 241 and the corresponding torque.
See the illustration of the ankle joint for the corresponding wrench sizes and tightening torque values (see fig. 1).

Installing the modules

INFORMATION
Ottobock recommends checking the alignment of the orthosis using the L.A.S.A.R. Posture or L.A.S.A.R. Posture 3D and adapting it as needed.

We recommend positioning the sagittal load line approx.15 mm in front of the knee compromise pivot point according to Nietert (see fig. 3, see fig. 4).

Thanks to the individual options for combining the specific modules with one another, the system ankle joint can be adjusted to needs of the patient. The adjustment of the alignment can be controlled via the angle adjustment of the system ankle joint. The angle adjustment can be set via the screw depth of the 17AD100A=AS, 17AD100A=LS setscrews and the 17AD100A=HS* stop pin.

INFORMATION
Bilateral design of the orthosis Ensure that the forces (e.g. compression spring force) are evenly distributed for the patient-specific setting.

Installing the Stop-module

Required materials: 17AD100A=MA* mounting adapter, torque wrench with bit, Torx wrench, 636K13 Loctite 241
Prerequisite: The ankle joint is mounted to the foot stirrup

Insert the threaded hole (see fig. 5, item 3) through the black cover from above.
Screw the threaded hole with cover into the basic piece from above (see fig. 15).
Place the mounting adapter on the threaded hole and tighten it with a torque wrench. Observe the specified torque (see fig. 11).
Insert the stop sleeve (item 2) into the threaded hole with the curve pointing towards the foot stirrup (see fig. 16).
Screw the setscrew (item 1) into the threaded hole with a Torx wrench and adjust the stop for the patient (see fig. 17). Secure with Loctite 241; observe the angle adjustment of the ankle joint.

See the illustration of the 17AD100A=AS* stop module for the corresponding wrench sizes and tightening torque values (see fig. 5).

Installing the Spring-module

Required materials: 17AD100A=MA* mounting adapter, torque wrench with bit, Torx wrench, 636K13 Loctite 241
Prerequisite: The ankle joint is mounted to the foot stirrup

Insert the threaded hole (see fig. 6, item 5) through the black cover from above.
Screw the threaded hole with cover into the basic piece from above (see fig. 10).
Place the mounting adapter onto the threaded hole and tighten it with the torque wrench. Observe the specified torque (see table) (see fig. 11).
Insert the ball (item 4) into the threaded hole from above (see fig. 12).
Guide the spring (item 2) into the spring guide housing (item 3) and position it in the threaded hole (see fig. 13).
Screw the setscrew (item 1) into the threaded hole with a Torx wrench and adjust the spring for the patient (see fig. 14). Secure with Loctite 241; observe the angle adjustment of the ankle joint.

See the illustration of the 17AD100A=LS* spring module for the corresponding wrench sizes and tightening torque values (see fig. 6).

Installing the Reaction-module

The Nexgear Tango Reaction-module is delivered installed in the cover (see fig. 7, item 11). First disassemble the module into individual components so that you can adjust it to the individual patient

NOTICE:

Do not install the Reaction-module without the cover.
Do not test on the patient or allow the patient to walk in this state.

Required materials: 17AD100A=MA* mounting adapter, torque wrench with bit, Torx wrench, 636K13 Loctite 241
Prerequisite: The ankle joint is mounted to the foot stirrup

Remove the cover cap (item 1) from the spring bolt (item 2) (see fig. 18).
Press the module out of the cover (see fig. 19).
Loosen the spring bolt (item 2).
Remove the spring dummy (item 3) (see fig. 20).
Remove the washer (item 5) (see fig. 21).
Loosen the spring holder (item 6) (see fig. 22).
Separate the spring plunger (item 7) together with the bearing sleeve (item 8) and the stop pin (item 10) from the support element (item 9) by pulling them out (see fig. 23). INFORMATION: Do not remove the stop pin (item 10) because this damages the thread lock on the stop pin.
Place the mounting adapter on the support element (item 9) and guide them into the cover (see fig. 24).
Mount the cover (item 11) with the flattened side on the basic piece of the ankle joint (see fig. 25).
Tighten the mounting adapter using the tightening torque of the support element (see fig. 26).
Remove the mounting adapter.
Position the spring plunger (item 7) together with the bearing sleeve (item 8) and the stop pin (item 10) in the cover on the support element (see fig. 27).
INFORMATION: It must be possible to screw the spring holder smoothly into the support element. If there is resistance while screwing it in, unscrew the spring holder and screw it in once more. Do not screw the thread in at an angle. Use a Torx wrench to insert the thread of the spring holder (item 6) into the spring plunger and tighten it with a torque wrench; use a bit extension for the torque wrench to do so. Observe the specified torque (see fig. 28, see fig. 29).
Position the washer (item 5) on the spring holder (see fig. 30).
Insert the spring dummy (item 3) into the module (see fig. 31).
Place the spring bolt (item 2) on the module and fasten it with a Torx wrench (see fig. 32). The spring dummy must fit in the module without play.
Put the orthosis on the patient (see fig. 33).

See the illustration of the Reaction-module for the corresponding wrench sizes and tightening torque values (see fig. 7).

Reaction module – static trial fitting

INFORMATION
The stop pin is equipped with a thread lock, which makes the stop pin hard to turn during adjustment. Do not turn the stop pin any more than necessary, since the thread lock is easily damaged and this can lead to premature wear and tear. Optionally the 17AD100A=MA* mounting adapter can be used with the Torx wrench for additional leverage.

Required materials: 743A8 knee pivot point gauge
Prerequisite: The Reaction-module is mounted to the spring dummy in the ankle joint.

Put the orthosis on the patient (see fig. 33).
Use the knee pivot point gauge to mark the compromise pivot point according to Nietert on the knee joint (see fig. 34).
Guide the Torx wrench through the spring bolt (see fig. 35) and adjust the stop pin (see fig. 7, item 10) to change the angle of the upper ankle joint. Relieve the lower leg by hand so that the stop pin moves easily in the thread (see fig. 36).
Readjust the stop pin if necessary so that the orthosis does not have any play in the anterior/posterior direction.
Check the static alignment of the orthosis using the L.A.S.A.R. Posture (see fig. 37).

Reaction module – dynamic trial fitting
Required materials: 17AD100A=HS--1 spring (strong) or 17AD100A=HS--2 spring (extra strong)
Prerequisite: The Reaction-module is mounted to the spring dummy in the orthotic ankle joint.

The spring dummy must be removed and replaced with the ReactionSpring prior to the dynamic trial fitting. Use a Torx wrench to loosen the spring bolt (see fig. 7, item 2) and remove it from the module.
Remove the spring dummy (item 3) and replace it with the ReactionSpring (item 4) (see fig. 38).
INFORMATION: Lubricate the spring bolt to prevent it from seizing. Then screw in the spring bolt flush with the cover (see fig. 39, see fig. 40).
Put the orthosis on the patient and perform a fitting.
Check the sagittal alignment of the patient on the L.A.S.A.R. Posture.
Set the desired pretension of the spring (see fig. 41).
Have the patient walk while wearing the orthosis.

Adjusting the Reaction-module in a bilateral orthosis
When using multiple Reaction-modules in a bilateral orthosis, observe the adjustment sequence. The stops and spring tension of the Reaction-modules that are medially and laterally opposite each other must have the same adjustment. Identical adjustment of the Reaction-modules 1 and 3 as well as 2 and 4 prevents deformation and damage to the orthosis.

Adjusting dorsiflexion and plantar flexion

Follow the steps described in “Installing the Reaction-module” and “Reaction- module – static alignment”.

The stops of the Reaction-modules are adjusted according to the following adjustment sequence. If a Reaction-module is not needed, omit the corresponding instructions.
Prerequisite: The orthosis has been applied to the patient.
Prerequisite: All Reaction-modules are mounted with the spring dummy.

Adjust the stop of Reaction-module 1 (see previous figure, see fig. 36)
Adjust the stop of Reaction-module 2 until the orthosis joint no longer exhibits any anterior-posterior play.
When Reaction-modules 1 and 2 have been adjusted, and Reaction module 3 is to follow: Loosen the spring bolt on Reaction-module 1.
Adjust the stop of Reaction-module 3 (if Reaction-module 1 is present, then identical to Reaction-module 1).
etighten the previously loosened spring bolt of Reaction-module 1.
If Reaction-module 4 is to be adjusted: Loosen the spring bolt on Reaction module 2.
Adjust the stop of Reaction-module 4 until the orthosis joint no longer exhibits any anterior-posterior play (if Reaction-module 2 is present, then identical to Reaction-module 2).
Re-tighten the previously loosened spring bolt of Reaction-module 2.
If a threaded hole is unused, close it with a blind cap.
If necessary, adjust the settings in the static alignment and repeat the steps.

Adjusting the spring tension

Follow the steps described in “Reaction-module – dynamic alignment”. The spring tension of the Reaction-modules is adjusted according to the following adjustment sequence. If a Reaction-module is not needed, omit the corresponding instructions.
Prerequisite: The orthosis has been applied to the patient.
Prerequisite: All Reaction-modules are mounted with the ReactionSprings.

Adjust the spring tension on the spring bolt of Reaction-module 1.
Adjust the spring tension on the spring bolt of Reaction-module 2.
Using callipers, measure and note down the insertion depth of the spring bolt in the cover of Reaction-modules 1 and 2 (see previous figure).
Adjust the spring tension on the spring bolt of Reaction-module 3. If Reaction-module 1 is installed, transfer the measured value from Reaction module 1 to Reaction-module 3.
Adjust the spring tension on the spring bolt of Reaction-module 4. If Reaction-module 2 is installed, transfer the measured value from Reaction module 2 to Reaction-module 4.
If a threaded hole is unused, close it with a blind cap.
Have the patient walk while wearing the orthosis. Readjust the springs if necessary, noting the adjustment sequence.

Cleaning

System joints must be cleaned promptly after contact with water containing salt, chlorine or soap, or when they get dirty.

Rinse system joints with clean fresh water.
Dry system joints with a cloth or allow to air dry. Avoid exposure to direct heat (e.g. from an oven or radiator).

Maintenance

INFORMATION
The product may be exposed to increased loads by the patient.

Shorten the maintenance intervals according to the expected loads.

The manufacturer requires at least a semi-annual inspection of the product
to verify functionality and check for wear. Corresponding service sets can be ordered for servicing the product.
Spare parts are listed in the section “Components/design”.
Only use 633F7 special lubricant.

Servicing the reaction module

Required materials: 17AD100A=MA* mounting adapter, torque wrench with bit, Torx wrench, 633F7 special lubricant

Inspect the Reaction-module for maintenance (see fig. 7).
INFORMATION: Disassemble the module if replacement is necessary due to signs of wear. This is apparent without disassembly. Unnecessary disassembly destroys the thread lock of the stop pin. Dismantle the Reaction-module into individual components.
Remove the cover cap (item 1) from the spring bolt (item 2).
Use a Torx wrench to loosen and remove the spring bolt (item 2). (Optional: If more then one component comes loose at the same time, it is possible to counter with a Torx wrench from below on the spring holder (item 6) so the components can be loosened and disassembled.)
Remove the Reaction-Spring (item 4) from the cover.
Remove the washer (item 5).
Use the Torx wrench to loosen and remove the spring holder (item 6).
Loosen the joint screw connection and remove the foot stirrup.
Apply slight pressure to a Torx wrench to press the spring plunger (item 7) with bearing sleeve (item 8) and stop pin (item 10) against the stop pin from below and remove them from the support element (item 9). Press the parts out of the cover (item 11) as you do so.
Set the mounting adapter onto the support element (item 9) and loosen it from the basic piece with a Torx wrench. INFORMATION: Inspect the support element semiannually in the course of maintenance and replace it with a new support element after one year.
Use a Torx wrench to loosen the stop pin (item 10) from the spring plunger and the bearing sleeve.
Pull the bearing sleeve (item 8) off the spring plunger (item 7) (2546884).

Inspection and lubrication

Check the cover cap (item 1) and the cover of the module (item 11) for wear and tear and replace if they show signs of wear.
Check the bearing sleeve (item 8) and the stop pin (item 10) and replace if they show signs of wear.
Apply a thin film of lubricant, only to the outer surfaces of the spring holder (item 6). Make sure to avoid applying too much lubricant!
Carefully check and clean all components prior to assembling them. Replace the components depending on the degree of wear.
See the section “Installing the Reaction-module” for the installation of the Reaction-module.

Disposal

Dispose of the product in accordance with national regulations.

Legal information

All legal conditions are subject to the respective national laws of the country of use and may vary accordingly.

Liability

The manufacturer will only assume liability if the product is used in accordance 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 unauthorized modification of the product.

CE conformity

The product meets the requirements of Regulation (EU) 2017/745 on medical devices. The CE declaration of conformity can be downloaded from the manufacturer’s website.

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