ottobock 6A40 Professionals MagnoFlex Lock Instructions

ottobock 6A40 Professionals MagnoFlex Lock Instructions

Product description

INFORMATION
Date of last update: 2021-06-07

• 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.

Construction and Function

The 6A40 MagnoFlex Lock is a shuttle lock with a flexible pin and a magnet integrated in the housing. It serves to secure a suitable liner in the prosthetic socket. The shuttle lock is installed in the check socket by vacuum forming and in the definitive socket by lamination. To connect to the distal prosthetic components, it is equipped with a fourhole connector. The flexible pin is installed on the liner. When sliding into the prosthetic socket, the magnet in the MagnoFlex Lock aligns the flexible pin with the opening. This makes it easier to don the prosthesis.

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

Designation| Reference num­

ber

---|---
Socket adapter| 4R54, 4R77
Slide plate

(The 4X314 spacer plate is required in addi­ tion.)

| 6A41

Intended use

Indications for use

The product is intended exclusively for lower limb exoprosthetic fittings.

Area of application

The maximum approved body weight is specified in the technical data.

Environmental conditions

Allowable environmental conditions

Temperature range for use: -10 °C to +60°C
Allowable relative humidity 0 % to 90 %, non-condensing
Unallowable environmental conditions

Mechanical vibrations or impacts
Perspiration, urine, fresh water, salt water, acids
Dust, sand, highly hygroscopic particles (e.g. talcum)

Lifetime

This product was tested by the manufacturer with 3 million load cycles. Depending on the user’s activity level, this corresponds to a maximum lifetime of 5 years.

Safety

Explanation of warning symbols

Warning regarding possible risks of accident or injury.

General safety instructions

Risk of injury and risk of product damage

• Comply with the product’s field of application and do not expose it to excessive strain (see page 12).
• Note the combination possibilities/combination exclusions in the instructions for use of the products.
• 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.
• Do not expose the product to prohibited environmental conditions.
• Check the product for damage if it has been exposed to prohibited environmental 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).
• 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 manufacturer or a specialist workshop).
• Keep the product away from devices and items that are sensitive to magnetic fields. (e.g. pacemakers, electronic devices, swipe cards). The magnets in the product may affect or damage other devices and objects.
• Pay attention to any information of the manufacturer regarding magnetic fields (e.g. for a medical implant).

Signs of changes in or loss of functionality during use

Among other factors, changes in functionality can be indicated by an altered gait pattern, a change in the positioning of the prosthetic components relative to each other and by the development of noises.

Scope of delivery

6A40

Fig.| Ite­

m

| Quant

ity

| Designation| Reference number
---|---|---|---|---
–| –| 1| Instructions for use| –
1| 1| 1| MagnoFlex Lock| –
 |  | 1| Set screw (for ratchet unit)| 506G3=M3X5-­

“Niro”

1| 2| 1| Lamination adapter| 6A43
1| 3| 1| Flexible pin| 6Y13=F1
1| 4| 1| Screw| 503S3
1| 5| 1| Vacuum forming dummy| –
1| 6| 4| Snap bushing| –
1| 7| 4| Cap screw| 501T28=M6X8
1| 8| 4| Flat head screw| 501S41=M6X45
1| 8| 4| Flat head screw| 501S41=M6X50
1| 9| 1| Ratchet unit| 5A52=K

6A43

Preparing the product for use

Incorrect alignment or assembly
Risk of injury due to damaged prosthetic components

Observe the alignment and assembly instructions.

INFORMATION

Not all of the materials may be available in your country. In this case, please contact the local branch of the manufacturer to obtain information on alternative materials.

Fabricating the prosthetic socket

INFORMATION
The layup described in this document was approved for the maximum product user body weight. The prosthetist assumes full responsibility for any change to the layup.

Preparing for socket fabrication
> Required tools and materials:
6A43 Lamination Adapter, 501T28=M6X8 Cap Screws, Vacuum forming dummy, 503S3 Screw, 633W8 Wax, 636K8=* Plastaband

1. Isolate the cap screws (thread and head from the outside) with wax.
2. Screw the cap screws into the lamination adapter (see fig. 2).
3. Fill the heads of the cap screws with Plastaband (see fig. 3).
4. Position the lamination adapter on the plaster positive along the longitudinal axis of the residual limb.
5. Place the vacuum forming dummy into the round opening of the lamination adapter and secure the two parts to the plaster positive with the flat head screw (see fig. 4).
6. Isolate the head of the flat head screw with Plastaband.
7. If there is an undercut between the lamination adapter and plaster positive: Fill the undercut with wet plaster.

**Fabricating a Check Socket

Required tools and materials:**

755T4=360 Outer Ring, 755X104=360 Vacuum Tube (with vacuum sealing ring), 755E9 Vacuum Pump, 756D2, 756B12= or 756B20= Oscillating Saw, 616T52= ThermoLyn rigid or 616T83= ThermoLyn clear, string

1. Prepare for fabrication of the prosthetic socket (see page 13).
2. Position two pieces of string crosswise on the lamination adapter (see fig. 5). The pieces of string form air channels that make it easier to mould the vacuum forming material to the contours.
3. Complete the vacuum forming process with ThermoLyn.
4. Finish the prosthetic socket.

**Laminating the transtibial socket

Required tools and materials:**

99B81=70X19X5 and 99B81=100X19X5 PVA Bag, 623T3=8 or 623T3=10 Perlon Stockinette, 81A1=8 or 81A1=10 Tube Sock, 616B1=25x* Carbon Fibre Cloth Strap, 616G2 Carbon UD Hose, 616G15 Carbon Fibre Woven Hose, 617H119 Orthocryl Lamination Resin 80:20 PRO, string

1. Prepare for fabrication of the prosthetic socket (see page 13).
2. Soak the shorter PVA bag and pull it over the plaster positive.
3. Pull a tube sock over the plaster positive.
4. Place a layer of carbon fibre cloth strap circularly around the  MPT (middle patellar tendon) point (see fig. 6).
5. Position a layer of carbon fibre cloth strap medially and laterally from the shuttle lock up to the condyles (see fig. 7).
6. Place a layer of carbon fibre cloth strap anteriorly and posteriorly from the shuttle lock to the circular carbon fibre cloth strap (see fig. 8).
7. Pull a tube sock over the plaster positive.
8. Loop a piece of string around the lamination adapter in the groove and tie tightly (##03119).
9. Cut a piece of carbon UD hose (1.5 times the length of the plaster positive).
10. Pull the carbon UD hose over the plaster positive up to the socket edge. Tie the upper section of the carbon UD hose and fold the remaining length over the plaster positive.
11. Loop a piece of string around the lamination adapter in the groove and tie tightly (see fig. 9).
12. Pull a tube sock over the plaster positive.
13. Cut a piece of carbon fibre woven hose (1.3 times the length of the plaster positive).
14. Pull the carbon fibre woven hose over the plaster positive to the socket edge. Tie the upper section of the carbon fibre woven hose and fold the remaining length over the plaster positive (see fig. 10).
15. Cut a piece of Perlon stockinette (twice the length of the plaster positive).
16. Pull the Perlon stockinette over the plaster positive up to the socket edge. Tie the upper section of the Perlon stockinette and fold the remaining length over the plaster positive.
17. Soak the longer PVA bag and pull it over the plaster positive.
18. Perform the casting process with Orthocryl.
19. Finish the prosthetic socket (see page 15).

Laminating a transfemoral socket

Required tools and materials:

99B81=100X26X5 and 99B81=130X26X5 PVA Bag, 623T3=12 or 623T3=15 Perlon Stockinette, 81A1=12 or 81A1=15 Tube Sock, 616B1=50x* Carbon Fibre Cloth Strap, 616G2 Carbon UD Hose, 616G15 Carbon Fibre Woven Hose, 617H119 Orthocryl Lamination Resin 80:20 PRO, string

1. Prepare for fabrication of the prosthetic socket (see page 13).
2. Soak the shorter PVA bag and pull it over the plaster positive.
3. Pull a layer of Perlon stockinette over the plaster positive.
4. Place a layer of carbon fibre cloth strap circularly 3 cm below the perineum.
5. Place a layer of carbon fibre cloth strap medially and laterally as well as anteriorly and posteriorly from the shuttle lock up to the circular carbon fibre cloth strap.
6. Place a layer of carbon fibre cloth strap circularly 3 cm below the perineum.
7. Cut two pieces of carbon fibre cloth strap (length approx. 20 cm).
8. Form the carbon fibre cloth straps into Vs by folding them in the middle and position them in the area of the tuberosity support.
9. Pull a tube sock over the plaster positive.
10. Loop a piece of string around the lamination adapter in the groove and tie tightly.
11. Cut a piece of carbon UD hose (1.5 times the length of the plaster positive).
12. Pull the carbon UD hose over the plaster positive up to the socket  edge. Tie the upper section of the carbon UD hose and fold the remaining length over the plaster positive.
13. Loop a piece of string around the lamination adapter in the groove and tie tightly.
14. Pull a tube sock over the plaster positive.
15. Cut a piece of carbon fibre woven hose (1.3 times the length of the plaster positive).
16. Pull the carbon fibre woven hose over the plaster positive to the socket edge. Tie the upper section of the carbon fibre woven tube and fold the remaining length over the plaster positive.
17. Cut a piece of Perlon stockinette (twice the length of the plaster positive).
18. Pull the Perlon stockinette over the plaster positive up to the socket edge. Tie the upper section of the Perlon stockinette and fold the remaining length over the plaster positive.
19. Soak the longer PVA bag and pull it over the plaster positive.
20. Perform the casting process with Orthocryl.
21. Finish the prosthetic socket (see page 15).

**Finishing the Prosthetic Socket

Required materials:**

Snap Bushings

1. Mark and trim the contour of the prosthetic socket.
2. Sand the distal end of the socket down to the vacuum forming dummy and the heads of the cap screws (see fig. 11).
3. On a level surface, check whether the sanded surface is flat. Rework as needed.
4. Remove the vacuum forming dummy and the cap screws from the prosthetic socket.
5. Remove the prosthetic socket from the plaster positive.
6. Sand the contour of the prosthetic socket.
7. Insert the snap bushings into the openings from which the cap screws were removed (see fig. 12).

Installing the Shuttle Lock and Socket Adapter

Using liquid thread lock
Risk of injury due screw connections ripping out
Do not use liquid thread lock (e.g. Loctite®). The thread lock damages the plastic material.

INFORMATION
The product contains a magnet
Maintain a safety distance of at least 12 cm from a pacemaker.

Required tools and materials:
Socket adapter, 501S41=M6X45 flat head screws, 506G3=M3X5-“Niro” set screw, 710D20 torque wrench, torque wrench (adjustable to 0.5 Nm)

1. Align the shuttle lock such that the magnet is aligned proximally and the ratchet unit medially or laterally.

2. Set the shuttle lock on to the prosthetic socket (see fig. 13).

3. Optional: Position the 4X314 spacer plate and then the 6A41 slide plate on the shuttle lock.

4. Position the chosen socket adapter on the shuttle lock.

5. Select the flat head screws for the socket adapter:
   For 4R54: 501S41=M6x45
   For 4R77: 501S41=M6x50

6. Insert the flat head screws through the socket adapter and the shuttle lock into the lamination adapter and tighten them (see fig. 14) (tightening torque: 12 Nm).

7. Screw the ratchet unit (see fig. 15, item 1) into the shuttle lock and tighten with the torque wrench (tightening torque: 10 Nm).

8. Secure the ratchet unit with the set screw (see fig. 15, item 2) (tightening torque: 0.5 Nm).

Mounting the pin

Installation of the pin in a liner that is not approved
Risk of injury due to loosening of the screw connection

Only install the pin in liners with a metal thread and observe the specified tightening torque.

The pin to connect the liner to the shuttle lock is screwed into the thread at the distal end of the liner.

Required tools and materials:
Torque Wrench (adjustable to 3 Nm), 636K13 Loctite®

1. Apply Loctite® to the thread.
2. NOTICE! Do not shorten the pin.
   Screw the pin into the thread and tighten it (see fig. 16) (tightening torque: 3 Nm).

Use

Pin not fully inserted into the lock
Risk of injury due to loss of connection to the prosthesis

• Guide the pin into the lock in accordance with the instructions.
• Always verify that the pin is engaged in the lock before using the prosthesis.

The liner and shuttle lock are connected to each other with the pin.
The pin engages in the shuttle lock and holds the liner in place.

Putting on the Liner

1. Check the pin and liner for damage. The pin must be flexible and always spring back to the original position.

2. NOTICE! Misaligning the pin leads to damage during insertion in the shuttle lock.
   Apply the liner on the end of the residual limb so that the pin is aligned with the longitudinal axis of the residual limb.

3. Roll the liner over the residual limb.

4. Check the fit of the liner and the alignment of the pin.

Donning the Prosthetic Socket

1. With the liner, slide into the prosthetic socket until the pin slides into the opening of the lamination adapter.

2. INFORMATION: While the pin is being inserted, clicking noises caused by the magnet and the ratchet unit can be heard. These noises do not indicate whether the pin is fully engaged in the ratchet unit.
   Insert the pin fully into the shuttle lock.

3. Before using the prosthesis, verify that the pin is fully engaged in the shuttle lock.

Doffing the Prosthetic Socket

Press and hold the side button and pull the residual limb with the liner out of the prosthetic socket.

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.

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 unauthorised modification of the product.

CE conformit

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.

Technical data

References

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