Ottobock 6Y200 Varos Liner Lower Limb Prosthetics User Manual

Ottobock 6Y200 Varos Liner Lower Limb Prosthetics

 | |
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6Y200=S-1| 310 – 350| 420 – 490
6Y200=SC-1| 480 – 550
6Y200=S-2| 330 – 370| 450 – 520
6Y200=SC-2| 510 – 580
6Y200=M-1| 360 – 410| 480 – 550
6Y200=MC-1| 530 – 610
6Y200=M-2| 390 – 440| 510 – 580
6Y200=MC-2| 560 – 650
6Y200=L-1| 400 – 450| 530 – 610
6Y200=L-2| 430 – 490| 560 – 650

Product Description

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.
• The patient must be fitted with the liner no later than the date printed on the inside of the packaging or on the label (MHD/BBD).

Function
The 6Y200 liner connects the residual limb to the 5A60 Varos prosthetic socket and reduces the forces acting on the residual limb. The liner is equipped with a textile coating and a magnetic cap, which improve the adhesion of the liner in the prosthetic socket.

Combination possibilities
The product is compatible with the specified Ottobock products. The functionality with products of other manufacturers was not tested.
Limited combination options for Ottobock components
The liner can only be combined with the 5A60=* Varos transfemoral socket (main product).

Intended use

Indications for use
The product is intended exclusively for lower limb exoprosthetic fittings.

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

Safety

Explanation of warning symbols

Warning regarding possible serious risks of accident or injury.

Warning regarding possible risks of accident or injury.
**** Warning regarding possible technical damage.

General safety instructions

Product is pulled over mouth and nose
Danger of suffocation due to lack of oxygen supply

• Store the product away from the reach of children.

Product contains magnets
Influence on or damage to devices or items due to a strong magnetic field

• Product contains magnets
• Influence on or damage to devices or items due to a strong magnetic field

Contact with cold, heat, embers or fire
Injuries (e.g. burns) caused by melting of the material and damage to the product

• Keep the product away from open flames, embers and other sources of heat.
• Do not expose the product to temperatures above +80 °C or below –20 °C.

Reuse on other persons and improper cleaning
Skin irritation, formation of eczema or infections due to contamination with germs

• The product may be used by one person only.
• Clean the product regularly.

Incorrect or excessively tight application of the product to the body
Risk of pressure points and constriction of blood vessels and nerves due to improper applica­tion

• Incorrect or excessively tight application of the product to the body
• Risk of pressure points and constriction of blood vessels and nerves due to improper applica­tion

Use of the product on damaged skin
Skin irritation, formation of eczema or infections due to contamination with germs

• Only use the product on healthy skin.

4 Scope of delivery

Preparing the product for use

Size selection

INFORMATION

Be sure to select the correct liner size. Possible problems are listed below.

• Liner too small: Feelings of numbness, formation of blisters, pistoning in the prosthetic socket
• Liner too large: Increased perspiration, rotation of the residual limb in the liner, formation of blisters, skin rash

1. Measure the proximal circumference of the residual limb 3 cm distal from the perineum.

2. Measure the distal circumference of the residual limb 5 cm proximal from the end of the resid­ual limb.

3. Measure the length of the residual limb from its end to the pubic bone. In doing so, straighten out any bulge in the soft tissue that may be present in the longitudinal axis of the residual limb.

4. Select the liner size that corresponds to the resulting measurement (see page 2).
   Optional: If the measurement lies between two sizes, try the other size.

5. Check the fit of the liner.

Adapting the liner

Determining the length

1. Add 5 cm to the previously measured residual limb length and make a mark on the medial seam of the liner.
2. Mark the trim line and cut the liner.
3. Put on the liner (see page 11).
4. Just below the perineum, make a mark on the medial seam of the liner.
5. Take the liner off again (see page 11).
6. Mark the trim line and cut the liner to the final length.

Marking the trim line and cutting the liner

Recommended tools for liners with a textile outer layer: 719S7 trimming scissors, 719S20 scissors for synthetic fibres or conventional scissors with a smooth blade

1. Position the liner on the workbench so the medial seam with the mark you have made is on top and centred.
2. Lay the trimming template with the medial side on the liner and align with the mark (see fig. 1).
3. Transfer the template outline to the liner using chalk.
4. Turn the liner so that the lateral seam is on top and centred.
5. Turn the template over and lay it on the liner (see fig. 2). The height aligns with the ends of the medial outline that you have marked out.
6. Transfer the template outline to the liner using chalk.
7. NOTICE! Do not use serrated scissors.
   Cut the liner along the outline that you have marked out. Note that the end of the liner must always be outside the prosthetic socket.

Use

CAUTION

Use of powder (e.g. baby powder or talcum)
Skin irritation on the residual limb and loss of function of prosthetic components due to clogging with particles or deprivation of lubricant

• Keep the product away from powders.

NOTICE

Mechanical overload
Impaired functionality due to mechanical damage

• Check the product for damage prior to each use.
• Do not use the product if its functionality has been impaired.
• Take any necessary measures (e.g. repair, replacement, inspection by the manufacturer’s customer service, etc.).

Putting on and taking off the liner Donning

INFORMATION

Wear the liner directly on the skin. Fabrics between the skin and the liner can cause skin irrita­tion.
If any allergic reaction occurs, immediately discontinue use and contact your medical profes­sional.

1. Check the liner and magnetic cap for damage. In doing so, remove any objects adhering to the magnetic cap.

2. Roll up the liner and place it on the end of the residual limb.

3. Align the liner (orientation thread centred on the front of the residual limb, magnetic cap in the longitudinal axis of the residual limb).

4. Unroll the liner without leaving wrinkles or displacing soft tissue, and without air pockets.

5. Check the fit and the alignment of the liner.
   INFORMATION: The end of the liner may not be inside the prosthetic socket.

6. Put the prosthetic socket on as described in the instructions for use for the prosthetic socket.

Doffing

1. Roll up the liner and remove it from the residual limb.
2. Recommendation: Clean the liner (see page 12)

Cleaning and Care

NOTICE

Use of improper cleaning agents
Damage to the product due to use of improper cleaning agents

• Only clean the product with the approved cleaning agents.

INFORMATION

Clean the liner and skin more frequently in case of increased perspiration. Wearing a liner requires daily intensive skin care. Ottobock recommends the use of the Derma skin care system.

Cleaning the inside

1. Turn the liner inside out.
2. Hand wash the liner in warm water (30 °C) using neutral detergent (e.g. 453H10=1 Ottobock Derma Clean).
3. Thoroughly rinse the liner with clear water until all detergent residues have been removed.
4. Turn the liner again so the outer side/textile material is on the outside.
5. Put a towel into the liner and allow the liner to dry lying flat on a drying rack. Alternatively, use a drying stand (5Y100=*).
   NOTICE! Liner with textile cover: To avoid damaging the liner, dry it with the textile material on the outside.

Cleaning the outside

• Clean the outside of the liner approximately every 1 or 2 weeks. The procedure is the same as for the inside of the liner.

Cleaning the magnetic cap

• Clean the cap with a dry or moist cloth.

Shipment

There must not be any significant magnetic effect on the outside of the packaging when the product is shipped. The provisions of the shipper must be observed.

1. Keep the original packaging in case the product needs to be shipped.
2. Tip: Tilt the packaging at a 45° angle and place a paper clip on it. If the paper clip slides off, no magnetic effect is present.

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.

Technical data

Liner without prosthetic socket

Measuring point| Magnetic flux density [mT]
Inside, close to the magnetic cap| <3
Inside, 10 cm from the magnetic cap| <0.05
Outside, close to the magnetic cap| <400
Outside, 10 cm from the magnetic cap| <0.2
Liner with prosthetic socket attached

Measuring point| Magnetic flux density [mT]
Inside, close to the magnetic cap| <15
Inside, 10 cm from the magnetic cap| <0.05
Exterior of prosthetic socket, close to the distal con­ nection| <10
Exterior of prosthetic socket, 10 cm from the distal connection| <0.05

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.

References

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