Fillauer Black Iron Lite Product Manual

Mechanical lock gripping devices

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Mechanical Lock
Distributeur
Gripping Devices
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Summary of Contents for Fillauer Black Iron Lite

  • Page 1 Mechanical Lock Distributeur Gripping Devices Product Manual...
  • Page 3: Table Of Contents

    Mechanical Lock Gripping Devices van Fillauer, distributeur Loth Fabenim B.V. Contents Intended Use / Purpose ......................Performance Characteristics ..............................................Products ..................Indications / Contraindications Storage and Handling ......................Warnings and Precautions ....................Qualified Provider ........................Specifications and Preparations Before Use ..............
  • Page 4: Intended Use / Purpose

    Mechanical Lock Gripping Devices van Fillauer, distributeur Loth Fabenim B.V. Intended Use / Purpose All the products listed above have the same basic function in that they are manually engaged and disengaged, mechanical, locking, gripping terminal devices. They can be operated as either right or left models. They are not cable operated and, in the USA, are most often classified as “Activity Specific”...
  • Page 5: Performance Characteristics

    Mechanical Lock Gripping Devices van Fillauer, distributeur Loth Fabenim B.V. Performance Characteristics 2.1 Products Black Iron Lite, Black Iron Lite Pivot, Black Iron Master, Black Iron Trainer, Black Iron Trainer Pivot All these terminal devices were primarily designed for resistance exercise using barbells, dumbbells (Free weights), as well as other types of exercise equipment where handles are used and engaged to perform and complete the activity.
  • Page 6 Mechanical Lock Gripping Devices van Fillauer, distributeur Loth Fabenim B.V. Performance Characteristics Hammerhead, Hammerhead Pivot These terminal devices were primarily designed to excel in performance in the activity of kayaking but have been applied to canoeing as well with more limited success.
  • Page 7: Indications / Contraindications

    Mechanical Lock Gripping Devices van Fillauer, distributeur Loth Fabenim B.V. Performance Characteristics 2.2 Indications / Contraindications General: Upper Extremity Terminal Devices-End Effectors: Prosthetic devices are tools designed to provide or replicate certain aspects and functions of the human hand including anatomical realism. All of these devices have benefits, limitations, ranges of function and liabilities that need to be understood by the user-consumer.
  • Page 8: Storage And Handling

    Mechanical Lock Gripping Devices van Fillauer, distributeur Loth Fabenim B.V. Storage and Handling It is recommended that Mechanical Lock Gripping Devices (or prosthetic/orthotic components) are stored in a cool, clean, dry environment away from harsh chemicals (chlorine, acids, acetone, etc.).
  • Page 9: Warnings And Precautions

    Mechanical Lock Gripping Devices van Fillauer, distributeur Loth Fabenim B.V. Warnings and Precautions CAUTION: Abnormal or improper environmental conditions will lead to malfunctioning and damage of the prosthesis and is 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, or activities which would damage the biological limb.
  • Page 10: Qualified Provider

    Mechanical Lock Gripping Devices van Fillauer, distributeur Loth Fabenim B.V. Qualified Provider Attachment, adjustment, alignment, and delivery of this device must be performed by or under the direct supervision of a qualified prosthetist. Unless stated in this manual, any such activities should not be attempted by the user and will potentially void the device warranty.
  • Page 11: Specifications And Preparations Before Use

    Mechanical Lock Gripping Devices van Fillauer, distributeur Loth Fabenim B.V. Specifications and Preparations Before Use 6.1 Specifications Product Name: Black Iron Master & Trainer Series Black Iron Black Iron Black Iron Specifications Master Trainer Trainer Pivot Lenght 3.5 in. (9.0 cm.) 2.6 in.
  • Page 12 Mechanical Lock Gripping Devices van Fillauer, distributeur Loth Fabenim B.V. Specifications and Preparations Before Use Product Name: Black Iron Lite Series Specifications Black Iron Lite Black Iron Lite Pivot Lenght 3.3 in. (8.4 cm.) 4.4 in. (11.0 cm.) Width 2.0 in. (5.0 cm.) 2.0 in.
  • Page 13 Mechanical Lock Gripping Devices van Fillauer, distributeur Loth Fabenim B.V. Specifications and Preparations Before Use Product Name: Hammerhead Specifications Hammerhead Lenght 4.3 in. (11.0 cm.) Width 2.7 in. (7.0 cm.) Weight 12.0 oz. (340 gm.) Accommodates a wide variety of round and shaped kayak...
  • Page 14: Preparation

    Will the person benefit from additional training in the use of the device? 6.3 Installation These Mechanical Lock Gripping Devices may be installed in any Fillauer TRS Omega Wrist, or any Fillauer LLC wrist unit with a ½-20 thread. Follow the instructions provided with the wrist unit for best results. 6.4 Cabling These Mechanical Lock Gripping Devices are designed to be used without any prosthetic cable systems.
  • Page 15: Compatibility

    Compatibility Fillauer TRS, Mechanical Lock Gripping Devices have been evaluated with and are recommended for use with Fillauer TRS Omega Wrists, and Fillauer LLC wrists that have a ½-20 internal thread. They may be used with any equivalent ½-20 threaded wrist units;...
  • Page 16: Care And Maintenance

    Mechanical Lock Gripping Devices van Fillauer, distributeur Loth Fabenim B.V. Care and Maintenance General: Upper Extremity Terminal Devices-End Effectors: Prosthetic devices should be used and treated as quality tools, regularly inspected for damage, deterioration and or excessive wear. The devices are waterproof and or highly water resistant and constructed of materials that will not rust or corrode or are resistant to such exposure.
  • Page 17: Disposal / Waste Handling

    Mechanical Lock Gripping Devices van Fillauer, distributeur Loth Fabenim B.V. 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.
  • Page 18: User Information

    Mechanical Lock Gripping Devices van Fillauer, distributeur Loth Fabenim B.V. User Information The providing health care professional must review the following information directly with the user. Consider the following factors as you prepare for this device: Are you able to donn and to doff the device independently?
  • Page 19: Warnings And Precautions For The User

    Mechanical Lock Gripping Devices van Fillauer, distributeur Loth Fabenim B.V. Warnings and Precautions for the User CAUTION: Abnormal or improper environmental conditions will lead to malfunctioning and damage of the prosthesis and is 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, or activities which would damage the biological limb.
  • Page 20: Serious Incidents

    Mechanical Lock Gripping Devices van Fillauer, distributeur Loth Fabenim B.V. Serious Incidents In the unlikely event of a failure resulting in a fall and/or injury, seek immediate medical help and contact your prosthetist at the earliest possible convenience. Mechanical Lock Gripping Devices Product Manual...
  • Page 21: Warranty

    Mechanical Lock Gripping Devices van Fillauer, distributeur Loth Fabenim B.V. Warranty This product has a 12-month warranty against manufacturer defects. Mechanical Lock Gripping Devices Product Manual...
  • Page 22 Fillauer Europe Kung Hans väg 2 192 68 Sollentuna, Zweden Tel: +46 (0) 8 505 332 00 Email: support@fillauer.eu www.fillauer.eu Contact Loth Fabenim B.V. De Liesbosch 14-G 3439 LC Nieuwegein, THE NETHERLANDS Tel: +31 30 27 32 506 Fax: +31 30 27 11 045 Email: sales@lothfabenim.nl...

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