Manufactured by: Centri Fax: Kung Hans Väg Sollentuna Sweden

Transcription

1 Manufactured by: Centri Fax: Kung Hans Väg Sollentuna Sweden Fillauer LLC (800) Fax: (423) Amnicola Highway Chattanooga, TN USA Hosmer (800) Fax: (408) Division Street Campbell, CA USA

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3 Introduction page 5 Features and Benefits page 6 Indications and Contraindications page 7 L-Codes for U.S.A. and Warranty page 8 Care and Maintenance page 8 Questions and Answers page 9 Instructions to Practitioner page 10 Instructions to Patient page 11 Choosing Absolute Liner Size page 12 Thermoforming Instructions page Order Information, Liner Sizes page 14-15

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5 Why choose between comfort and durability when you can have the absolute best in softness, comfort, fit, and durability. Some gel liners ask the patient to choose between durability and softness. We know that your patients demand both, so we worked to formulate a more advanced, better fitting, gel liner that combines the best aspects of softness, comfort, fit, and durability into one material. Our liner offers a more comfortable, natural feel that will endure longer than other liners. Extra cushion and thickness, where it s needed, gives comfort and protection to the wearer. The Absolute Liner is available as a cushion or locking liner and is available in a variety of styles and sizes that allow the practitioner to provide a comfortable fit for every user. Off-the-shelf fit is achieved by offering 4 sizes of each style: 3mm uniform and 6mm tapered. The embedded stabilizing fabric in the Absolute Liner reduces pistoning at the distal end of the limb and prevents the milking sensation. Medical grade mineral oil is infused in every Absolute Liner for healthy skin. The Absolute Liner is also thermoformable, allowing it to be custom fit to a specific limb shape. The Absolute Liner comes in two densities: extra-soft and medium-soft. This allows the user to choose their individual comfort preference. Durability is enhanced by using the highest grade FDA approved elastomers and materials. The TPE gel material allows for greater heat transfer than silicone, making it feel cooler. Micro-coated vinyl fabric makes donning and doffing easy and cleaning simple. We are sure your patients will like the Absolute Liner. A six month warranty comes with every liner, 12 months for two liners used alternately. To be Absolutely sure: Choose the Absolute Liner!

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7 Features and Benefits Locking or Cushion Liner Off-the-shelf convenience Thermoformable for custom fit Micro-coating for easy donning and doffing Set screw for distal attachment in locking liner Gel with embedded stabilizing fabric FDA approved elastomer Infused with medical grade mineral oil Extra distal thickness for comfort 4 different sizes ranging from 14-31cm (5.5-12in) 3 mm uniform or 6 mm tapered thickness Extra-soft or medium-soft liner durometers Greater heat transfer than silicone indications General amputee population Limb shapes requiring a more customized shape Residual limbs needing increased cushioning and shear relief Locking Liner for pin suspension Cushion Liner for suction suspension contraindications Poor hand dexterity or strength Excessive limb perspiration Allergic reactions or extremely sensitive skin Poor Hygiene may cause skin irritations US Patent # Swedish #

8 L-Codes Accurate L-Code reporting to the third party payer remains the responsibility of the prosthetic and orthotic service provider. The manufacturers and distributors of the prosthetic products do not assume any liability for L-Code recommendations. L5673 Addition to lower extremity, below knee/above knee, custom fabricated from existing mold or prefabricated, socket insert, silicone gel, elastomeric or equal, for use with locking mechanism L5679 Addition to lower extremity, below knee/above knee, custom fabricated from existing mold or prefabricated, socket insert, silicone gel, elastomeric or equal, not for use with locking mechanism These L-Codes may be applicable for billing in the U.S.A. Each code should be reviewed for appropriateness, functional equivalency, and medical necessity. Additional L-Codes may be appropriate with other components or modifications. Warranty The Absolute Liner gives a warranty of 6 months for one Absolute Liner, 12 months for two Absolute Liners used together. Alternating two Absolute Liners, as suggested, maximizes the life of the Absolute Liner and is recommended. Care and Maintenance A mild soap solution or alcohol can be used to clean the Absolute Liner. The Absolute Liner should be rinsed and dried thoroughly to prevent any soap residue from being retained in the Absolute Liner and causing skin irritation. CAUTION: Using Acetone or similar chemical solvents will destroy the Absolute Liner and void the warranty.

9 Questions and Answers What is the Absolute Liner made of? The Absolute Liner is made of Thermoplastic Elastomer (TPE). This user friendly TPE is specially formulated to be supple and formable, making it ideal for thermoforming. It also has higher heat transfer than silicone, making it feel cooler. What is the benefit of micro-coating? The layer of friction-reducing micro-coating on the outer fabric makes the Absolute liner easy to reflect without spraying alcohol or using powder. It also resists staining and lets the Absolute Liner slip into the socket more easily. What are the different types of Absolute Liners? The Absolute Liners are available in a variety of sizes. There is a Locking Liner with threaded 10mm distal end attachment and a Cushion Liner for use with suction suspension. All are available in a 3mm uniform and 6mm tapered thickness and in extra soft and medium soft. What are the different sizes of Absolute Liners? 3 mm uniform thickness or 6mm tapered thickness Distal Circumference Proximal Circumference 14-17cm 23-28cm 18-21cm 25-31cm 22-25cm 30-37cm 26-31cm 34-42cm How should the Absolute Liner be cleaned? A mild soap solution or alcohol can be used to clean the Absolute Liner. The Absolute Liner should be rinsed thoroughly to prevent any soap residue from being retained in the Absolute Liner and causing skin irritation. CAUTION: Using Acetone or similar chemical solvents will destroy the Absolute Liner and void the warranty. What warranty is available? The Absolute Liner gives a warranty of 6 months for one Absolute Liner, 12 months for two Absolute Liners used together. Alternating two Absolute Liners, as suggested, maximizes the life of the Absolute Liner and is recommended. How should the Absolute Liner be cut? The Absolute Liner should be trimmed with sharp scissors. The practitioner should try to cut the Absolute Liner with one continuous cut. If the skin becomes irritated a scalloped edge cut may be made to prevent rim pressure. Any edge notches may result in the Absolute Liner tearing.

10 Instructions to Practitioner EXTREMELY IMPORTANT: The Liner plunger must be secured with Loc-Tite. If Loc-Tite is not used the patient may inadvertently lose suspension and void warranty. The Absolute Liner can be used off-the-shelf or may be thermoformed to a custom shape. Thermoforming should be done at (80º- 85ºC) 175º-185º F (see page 12). Increased temperature will affect durability. The Absolute Liner should be allowed to cool naturally at room temperature. Shock cooling with air or water may result in a tear. The Absolute Liner should be trimmed with sharp scissors. The practitioner should try to cut the Absolute Liner with one continuous cut. If the skin becomes irritated a scalloped edge cut may be made to prevent rim pressure. Any edge notches may result in the Absolute Liner tearing. The Absolute Liner gives a warranty of 6 months for one Absolute Liner, 12 months for two Absolute Liners used together. Alternating two Absolute Liners, as suggested, maximizes the life of the Absolute Liner and is recommended. The practitioner should instruct the patient to wash the Absolute Liner and the residual limb daily for proper hygiene. The Absolute Liner should be stored away from heat and exposure to direct sunlight. Socket trim lines should be rounded and smooth to avoid cutting the proximal Liner. 10

11 Instructions to Patient The Absolute Liner is applied by reflecting the Liner fully and placing the bottom firmly against the end of the residual limb. Orient the Absolute Liner for proper position and reflect completely over the limb. The Absolute Liner should never be pulled on. CAUTION: Acetone or similar chemicals will destroy the Absolute Liner and void the warranty. The Absolute Liner and residual limb should be inspected daily. Any notches or scratches at the top edge of the Absolute Liner should be trimmed to prevent tearing. The Absolute Liner should only be trimmed by the prosthetist. Please note, Locking Liners should be inspected at the distal end for any holes or attachment security. Excessive perspiration may be present initially (sometimes for several weeks), but should dissipate over time. Excessive perspiration that continues, may cause the Absolute Liner to lose suspension. Any skin reactions should be noted and reported to the prosthetist immediately. The Absolute Liner should feel snug, even tight, at first, but should not cause, throbbing sensation, or pain. The residual limb and the liner should be kept clean to prevent reaction and skin rashes. The Absolute Liner should be protected from excessive heat or direct sunlight which may degrade the Liner. The Absolute Liner gives a warranty of 6 months for one Absolute Liner, 12 months for two Absolute Liners used together. Alternating two Absolute Liners maximizes the life of the Absolute liner and is recommended. I received the Instructions to Patient card Patient s Signature Practitioner Signature Date Liner Serial Number Serial Number can be found on inside distal end of every liner. 11

12 Preparing the Absolute Liner for Thermoforming 1- Take a circumference measurement 5cm from distal end of the residual limb. 2- Using the size chart choose a corresponding size of Absolute Cushion Liner or Absolute Locking Liner. (Choose a smaller size if in-between sizing.) 3- Inspect the liner to insure there are no cuts or scratches from fabrication processes. 4- Protect the liner from any contact with chemicals such as acetone. Thermoforming Instructions Before thermoforming the Centri Absolute Liner, make sure you have the correct liner size. The Absolute Liners are designed to stretch up to 1.75 times their original size. Stretching the Absolute Liner more than this may result in the Absolute Liner splitting during the forming process. 1- Turn the Absolute Liner inside out. 2- Position the Absolute Liner against the distal end of the positive model. Reflect the Absolute Liner over the positive model. DO NOT PULL. THE LINER MAY STRETCH. Inspect that there are no wrinkles or air pockets inside the liner. Check to see that the distal end of the Absolute Liner is correctly positioned. (Distal pin placement is especially important when using a Locking Liner.) Insert the plunger to verify position then remove the plunger. 12

13 3- No hot surface should come into contact with the Absolute Liner, therefore a free standing positive model (plaster or foam) with a mold stand should be used. Place the model in 80 C-85 C (175 F- 185 F) oven for minimum of minutes. Do not raise the oven temperature over 85 C (185 F). The longer the time spent in the oven, the more the liner takes shape of the model. Use a temperature gauge to measure oven temperature. Follow time and oven temperature guidelines for good thermoforming results. Over-heating and too much time will damage the liner. 4- Remove the positive model with the Absolute Liner from the oven. The Absolute Liner should not be touched until it cools to room temperature. NOTE: For more definition, apply a separating balloon or bag over the Absolute Liner, then apply mild vacuum until the liner cools to room temperature. 5- Remove the Absolute Liner by reflecting the top edge and sliding off. Trim proximal end of Absolute Liner to desired shape. A sharp cutting tool is recommended. For more information on various casting techniques call the Fillauer Companies: Fillauer LLC (800) Hosmer (800) Centri

14 Choosing the Correct Liner Size 1- Take a circumference measurement 5cm from distal end of the residual limb 2- Using the size chart choose a corresponding size of Absolute Cushion Liner or Absolute Locking Liner. (Choose a smaller size if in-between sizing.) Distal Circumference 5cm (2in) from distal end 3mm Uniform Proximal Circumference 40cm (15.75in) from distal end Extra Soft Medium Soft 14-17cm ( in) 23-28cm ( in) cm (7-8.26in) 25-31cm ( in) cm ( in) 30-37cm ( in) cm ( in) 34-42cm ( in) Distal Circumference 5cm (2 in) from distal end 6mm Tapered Proximal Circumference 40cm (15.75 in) from distal end Extra Soft Medium Soft 14-17cm ( in) 23-28cm ( in) cm (7-8.26in) 25-31cm ( in) cm ( in) 30-37cm ( in) cm ( in) 34-42cm ( in) NOTE: Sizing for each liner can be found on the inside near the distal end of the liner. US Patent # Swedish # Cushion Liner

15 Choosing the Correct Liner Size 1- Take a circumference measurement 5cm from distal end of the residual limb 2- Using the size chart choose a corresponding size of Absolute Cushion Liner or Absolute Locking Liner. (Choose a smaller size if in-between sizing.) Distal Circumference 5cm (2 in) from distal end 3mm Uniform Proximal Circumference 40cm (15.75 inches) from distal end Extra Soft Medium Soft 14-17cm ( in) 23-28cm ( in) cm (7-8.26in) 25-31cm ( in) cm ( in) 30-37cm ( in) cm ( in) 34-42cm ( in) Distal Circumference 5cm (2 in) from distal end 6mm Tapered Proximal Circumference 40cm (15.75 inches) from distal end Extra Soft Medium Soft 14-17cm ( in) 23-28cm ( in) cm (7-8.26in) 25-31cm ( in) cm ( in) 30-37cm ( in cm ( in) 34-42cm ( in) NOTE: Sizing for each liner can be found on the inside near the distal end of the liner. US Patent # Swedish # Locking Liner

16 Fillauer LLC (800) Hosmer (800) Centri M030/09-05