ottobock 452A1 ProSeal Ring Instruction Manual

ottobock 452A1 ProSeal Ring

Product description

INFORMATION
Date of last update: 2021-12-16

• 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 452A1 ProSeal ring is intended for the proximal sealing of a prosthetic socket for the thigh with the use of active and passive vacuum systems. The prosthetic socket has to be custom fab­ricated for the use of a ProSeal ring. The ring is glued into the prosthetic socket.

Intended use

Indications for use
The product is intended exclusively for lower limb exoprosthetic fittings. The product must be used in TF prostheses only.

Lifetime
The product is a wear part, which means it is subject to normal wear and tear.

Safety

Explanation of warning symbols

WARNING
Warning regarding possible serious risks of accident or injury.

CAUTION
Warning regarding possible risks of accident or injury.

NOTICE
Warning regarding possible technical damage.

General safety instructions

CAUTION!
Risk of injury and risk of product damage

• 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).
• Make sure the product is applied properly and fits correctly. Improper or excessively tight application can cause pressure points and constriction of blood vessels and nerves.
• Do not continue to use the product if it does not fit properly.

Skin irritation, formation of eczema or infections due to contamination with germs

• The product may only be used by one person; reuse on another person is prohibited.
• Observe the cleaning instructions.

NOTICE!
Risk of product damage and limited functionality ****

Scope of delivery

Preparing the product for use

Preparing a plaster model
Requirement : The socket encompasses the ischium.

1. Measure the circumference of the residual limb after putting on the liner, prepare the plaster cast and fabricate the plaster model.
2. Based on the circumference measurements taken on the patient: Reduce the circumference of the plaster model 5 cm distal to the perineum by 1 cm
3. Create a soft, round shape in the course of this reduction.
4. Do not reduce the remaining plaster model.

Size selection

1. Measure the circumference of the plaster model 3 cm to 5 cm distal to the perineum.
2. The ProSeal ring can be inserted into the prosthetic socket at a slight angle to the longitudinal axis.
3. Medially (in the area of the perineum), the ring should be at least 3 cm to 5 cm below the socket brim
4. Select the appropriate ProSeal ring. If the measurement is between two sizes, select the larger ring.

Fabricating the prosthetic socket

INFORMATION
The lamination dummy may be used for a complete fitting process. Observe the information for use and dispose of the dummy after fabricating the definitive prosthetic socket.

• Prosthetic socket made of thermoplastic material: Place a textile material (e.g. 99B25) under the lamination dummy during fabrication. This ensures the optimal fit of the ring in the recess of the prosthetic socket.
• Soft-walled inner socket: Note that the thermoplastic material of the inner socket must exhibit virtually no shrinkage.
• Prosthetic socket with lamination technique: Pull a moistened PVA bag over the lamination dummy.

Positioning the lamination dummy

1. Align the lamination dummy. The triangular mark has to face the distal socket end.
2. Position the lamination dummy on the plaster model and check that it fits perfectly against the plaster model.
3. Fabricate the prosthetic socket.
4. Remove the dummy from the groove and put it aside.

NOTICE! Dispose of the dummy after fabricating the definitive prosthetic socket.

Installing the ProSeal ring

1. Clean the ProSeal ring and the groove in the prosthetic socket with isopropyl alcohol.
2. Distribute silicone bonding agent in the groove in the prosthetic socket.
3. Align the ProSeal ring with the size marking facing in the proximal direction and insert it into the groove in the prosthetic socket. TIP : Pull the ring into the groove from distal to proximal.
4. Remove excess bonding agent and allow the bonding agent to cure.

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 procedures.

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 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.

References

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