Fillauer CAPP User manual

CAPP & Shapeable

Passive Hand Wrists

Product Manual

Contents

Intended Use................................................................3

Warnings and Precautions ....................................................4

Qualied Provider ...........................................................4

Specications and Preparations BeforeUse

(Risk Management for Installation andCalibration) ...............................5

CAPP Wrist Assemblies .......................................................6

Disposal / Waste Handling ....................................................6

Warranty ...................................................................6

User Instructions ............................................................7

Serious Incidents ............................................................8

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Intended Use

CAPP and Shapeable Passive Hand Wrists are plastic constant-friction wrist rotation

units. Fine friction adjustment can be obtained with exceptionally smooth and constant

friction throughout the entire turning arc. These wrist units are lightweight, shapeable

wrists for passive, lightweight, and pediatric devices.

Performance Characteristics

• Constant friction applied with unique friction adjustment collar

• Lightweight and shapeable wrist for passive and lightweight devices

• ½-20 thread

CAPP Wrist

Material Diameter Build Height Weight Product

Number

Delrin 1.5in.

(38mm)

0.63in.

(16mm)

0.6 oz.

(16 g) 55108

Delrin 1.75in.

(44mm)

0.63in.

(16mm)

0.8 oz.

(22 g) 55109

Delrin 2.0in.

(51mm)

0.63in.

(16mm)

1.1 oz.

(30 g) 55110

Shapable Passive Hand Wrist

Material Diameter Build Height Weight Product

Number

ABS 1.9×1.4in.

48×36mm

0.68in.

(17mm)

0.6 oz.

(16 g) 62022

ABS 2.2×1.5in.

56×38mm

0.68in.

(17mm)

0.8 oz.

(22 g) 62021

ABS 2.6×1.7in.

66×43mm

0.68in.

(17mm)

1.1 oz.

(30 g) 62020

The device is intended for single user/patient use only.

Storage and Handling

It is recommended that prosthetic wrists be stored in a cool, clean, dry environment

away from harsh chemicals (chlorine, acids, acetone, etc.).

Warnings and Precautions

NOTICE: An upper-limb prosthetic device user’s ability to drive should

be determined on a case-by-case basis by a specialist. Contact your local

governing authorities regarding any driving restrictions or limitations.

WARNING: Body-powered devices should not rely on cable tension for

grasp control if the user has been cleared to drive with the prosthesis.

Failure to maintain tension while controlling the steering wheel could

cause serious injury or death.

CAUTION: Do not tighten the friction screw without rst inserting a

terminal device with a ½-20 thread.

CAUTION: Abnormal or improper environmental conditions will lead

to malfunctioning and damage of the prosthesis and are not covered

under the warranty of the device. This prosthetic component must not

be subjected to dust/debris, liquids other than fresh water, abrasives,

vibration, activities which would damage the biological limb, or prolonged

extreme temperatures (<-5°C or >50°C). Do not allow debris or liquids

to remain in the prosthesis and its components during use. Rinse the wrist

with fresh water and dry immediately after exposure.

CAUTION: The wrist unit is waterproof to 1 meter. However, if the wrist is

submerged, it should be rinsed with fresh water and dried immediately to

remove salt, chlorine, or debris.

Qualied Provider

Attachment, adjustment, alignment, and delivery of this device must be performed by

or under the direct supervision of a qualied prosthetist. Unless stated in this manual,

any such activities should not be attempted by the user and will potentially void the

device warranty.

Specications and Preparations BeforeUse

(Risk Management for Installation

andCalibration)

Alignment

Prosthetic wrists should be aligned to provide the best possible work envelope for

the patient’s specic goals. Standard alignment begins at 5° of exion and 5° of radial

deviation but should be tailored to the individual patient.

Lamination Instructions

1. Check to make sure that the wrist can be placed on the distal end of the socket

in such a way that the internal components do not contact the inner socket

before the wrist body.

2. Cover both at surfaces of the unit with two layers of masking tape. Plug the

adjustment screw hole with beeswax, foam plater, or similar.

3. A PVA bag should be used to separate the wrist housing from the forearm mold

if foam or plaster are used.

4. Wax the interior surface of the wrist housing and the distal face of the housing.

5. Pack the wrist housing with silicone tting gel or similar to prevent it from lling

with laminate.

6. Mask the housing distal to the tie-in groove on the lamination ring to preserve

access to any moving components and to keep all laminate clear of the

distalend.

7. The position of the adjustment screw must be well marked before starting

lamination.

8. After lamination, cut out the hole for the adjustment screw.

9. Laminate with the appropriate materials for durability and nish as desired by

the patient.

CAPP Wrist Assemblies

55108 CAPP Wrist 1412, 1 ½in. (3.8cm) Diameter

55109 CAPP Wrist 1413, 1 ¾in. (4.4cm) Diameter

55110 CAPP Wrist 1414, 2in. (5.1cm) Diameter

A. 55105 Housing, 55108

55106 Housing, 55109

52805 Housing, 55110

B. 59711 Clamp Assembly

C. 56661 Socket Head Screw

55313 Allen Wrench, (Not Shown)

Disposal / Waste Handling

The product must be disposed of in accordance with applicable local laws and

regulations. If the product has been exposed to bacteria or other infectious agents,

it must be disposed of in accordance with applicable laws and regulations for the

handling of contaminated material.

All metal components may be removed and recycled at the appropriate recycling

facility.

Warranty

This product has a 12-month warranty against manufacturer defects.

User Instructions

The providing health care professional must review the following information directly

with the user.

Warnings and Precautions for the User

NOTICE: The user should monitor their prosthesis daily and contact their

health care professional if they experience changes in device performance

or if it begins to make noise.

CAUTION: All maintenance should be performed by the qualied health

care professional.

NOTICE: An upper-limb prosthetic device user’s ability to drive should

be determined on a case-by-case basis by a specialist. Contact your local

governing authorities regarding any driving restrictions or limitations.

CAUTION: Body-powered devices should not rely on cable tension for

grasp control if the user has been cleared to drive with the prosthesis.

Failure to maintain tension while controlling the steering wheel could

cause serious injury or death.

CAUTION: Do not tighten the friction set screw without rst inserting a

terminal device with a ½-20 thread.

CAUTION: Abnormal or improper environmental conditions will lead

to malfunctioning and damage of the prosthesis and are not covered

under the warranty of the device. This prosthetic component must not

be subjected to dust/debris, liquids other than fresh water, abrasives,

vibration, activities which would damage the biological limb, or extreme

temperatures (<-5°C or >50°C). Do not allow debris or liquids to remain

in the prosthesis and its components during use. Rinse the device with

fresh water and dry immediately after exposure.

CAUTION: The wrist unit is waterproof to 1 meter. However, if the wrist is

submerged, it should be rinsed with fresh water and dried immediately to

remove salt, chlorine, or debris.

www.llauer.com

Fillauer LLC

2710 Amnicola Highway

Chattanooga, TN 37406

423.624.0946

Fillauer Europe

Kung Hans väg 2

192 68 Sollentuna, Sweden

+46 (0)8 505 332 00

EC REP

M096/01-28-22/Rev.1

Serious Incidents

In the unlikely event a serious incident occurs in relation to the use of the device, users

should seek immediate medical help and contact their prosthetist, local competent

authority, and Fillauer at the earliest possible convenience. Clinicians should at

any time contact their local Fillauer representative and local competent authority

immediately in the event of any device failure.

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