Fillauer Black Iron Lite User manual

Distributeur
Mechanical Lock
Gripping Devices
Product Manual

EN
3
Mechanical Lock Gripping Devices van Fillauer, distributeur Loth Fabenim B.V.
Mechanical Lock Gripping Devices Product Manual
Contents
1. Intended Use / Purpose ......................................................................................................... 4
2. Performance Characteristics ................................................................................................5
2.1 Products ................................................................................................................................5
2.2 Indications / Contraindications .......................................................................................... 7
3. Storage and Handling ............................................................................................................. 8
4. Warnings and Precautions .................................................................................................... 9
5. Qualied Provider ..................................................................................................................10
6. Specications and Preparations Before Use .................................................................11
6.1 Specications ..................................................................................................................... 11
6.2 Preparation ........................................................................................................................ 14
6.3 Installation ..........................................................................................................................14
6.4 Cabling ................................................................................................................................ 14
7. Compatibility ........................................................................................................................... 15
8. Care and Maintenance ......................................................................................................... 16
9. Disposal / Waste Handling .................................................................................................. 17
10. User Information ....................................................................................................................18
11. Warnings and Precautions for the User .......................................................................... 19
12. Serious Incidents .................................................................................................................... 20
13. Warranty ...................................................................................................................................21

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Mechanical Lock Gripping Devices van Fillauer, distributeur Loth Fabenim B.V.
Mechanical Lock Gripping Devices Product Manual
Intended Use / Purpose
1
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 classied as “Activity Specic” terminal devices. They are
designed to capture and hold objects with a clamp, exible strap or ratchet closure
strap system for optimal use with cylindrical and semi-cylindrical shaped objects
and handles. They all provide stable, strong and secure control over the objects
engaged but all require a manual “release” of a mechanism or strap to disengage
from those objects. All these devices mount and connect easily to any USA standard
prosthetic wrist.
These devices are intended for single user/patient use only.

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Mechanical Lock Gripping Devices van Fillauer, distributeur Loth Fabenim B.V.
Mechanical Lock Gripping Devices Product Manual
Performance Characteristics
2
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. The
PIVOT models are slightly longer but provide an additional range of motion to
help mitigate or eliminate excessive compensatory movements at the elbow and
shoulder for more natural biomechanics throughout the exercise. The BLACK IRON
LITE (BIL) and BLACK IRON LITE PIVOT are lighter-duty devices designed primarily for
aerobic dumbbell exercise.
They are not recommended for weight resistance activities in excess of 10 pounds
(4.5 KG). They incorporate a ratchet strap system to secure the weights into the
terminal device. The BLACK IRON TRAINER (BIT) AND BLACK IRON TRAINER PIVOT
models, which weigh about 1 pound (440 gm), are the most popular designs capable
of handling loads in excess of 400 pounds (~200 kg). These models will meet the
needs of almost all persons with a hand absence wanting to weight train. The BIT
and BIM both use a swing up “gate” closure and large bolt and wing nut assembly
to capture handles and securely lock in the weights to the prosthesis. The BLACK
IRON MASTER (BIM), which weighs 25 ounces (~700 gm,), is a professional level
weight training device capable of controlling loads of over 1600 pounds (~700kg). It
is recommended for use only by professional body builders and other athletes who
seek exceptionally high performance and load capacity in their exercise training
regime.
2.1 Products
Flexible Thing
The Flexible Thing is a terminal device designed primarily for water sports like water
skiing, where bilateral control over a “tow handle” is required but where safety
necessitates the ability to release the handle instantly during a mishap or fall to
avoid injury. The device requires the “over-grasping” of a strap, which is wrapped
around the handle, by a “sound” hand, to keep it engaged onto any tow handle. The
Flexible Thing is also equipped with a special buckle into which the strap can be
woven for a multitude of other tasks where control over cylindrical handles typical in
shovels, rakes, etc.is required for yard work or carrying heavy handled objects. This
feature provides the Flexible Thing to be categorized as a true “cross-over” type of
terminal device because of it multi-use applications and capabilities.

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Mechanical Lock Gripping Devices van Fillauer, distributeur Loth Fabenim B.V.
Mechanical Lock Gripping Devices Product Manual
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. The Hammerhead uses a solid polymer body and strong elastic strap which
wraps over and secures the kayak paddle shaft into the device. A cylindrical handle in
the end of the strap allows the strap to be manually snapped down and locked into
position over a pedestal. The same handle provides for the ability to manually grasp
and release the strap thereby freeing the paddle from the control of the device. The
Hammerhead operates either right or left and replicates the biomechanical motions
of the hand, wrist and forearm used to propel a kayak or similar water craft. The
Hammerhead Pivot model is longer and adds additional radial-ulnar movement
at the wrist that enhances performance and helps mitigate or eliminate excess
compensatory movements at the elbow and shoulders while paddling. Both devices
are totally waterproof and can be used in both fresh and salt water environments.
Performance Characteristics
2
ISHI, ISHI HD, Multi-D, Multi-D Pivot
These products are truly “cross-over” terminal devices and can be used for a wide
variety of holding tasks and are especially created for holding cylindrical shaped
handles and objects. They operate as either right or left models. Both the ISHI and
Multi-D utilize exible grasping “ngers” or “mandibles” biased together with high
strength, quick release, ratchet strap, closure mechanisms. The ISHI and ISHI HD
were original conceived and designed for holding a bow or shing rod but they
function very well in holding other tools and implements in a narrow diameter range
up to ~2 inches (~5 cm). The MULTI-D is a larger version of the ISHI design but with
broader mandible gripping surfaces and a heavier capacity ratchet strap closure
system for heavier duty use and activities. The Multi-D can handle objects of bigger
diameter out to ~ 3 inches (7.6 cm). The Multi-D Pivot is longer, slightly heavier and
provides radial-ulnar or exion-extension types of wrist movement depending on
how it is mounted on the prosthetic wrist. Both these devices are waterproof. The
Multi-D has been used for vocational tasks like using drills and hammers but can
also “crossover” and be used for holding kayak, canoe and standup style, paddle
board paddles and for controlling boat oars, which are large in diameter than most
paddle-style handles and grips.

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Mechanical Lock Gripping Devices van Fillauer, distributeur Loth Fabenim B.V.
Mechanical Lock Gripping Devices Product Manual
Performance Characteristics
2
General:
Upper Extremity Terminal Devices-End Eectors:
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
benets, limitations, ranges of function and liabilities that need to be understood
by the user-consumer. The basis for any reliable functional outcome in using these
devices is premised upon having a well-designed, reliably suspended, comfortable,
functional prosthetic limb, which optimizes the user’s remaining physical capabilities;
including range of limb motion and strength. The remaining limb itself, is a very
basic limiter of function and performance. Typically, the longer the limb the more
functional capacity over a prosthesis will be achieved, assuming the limb’s muscular
and skeletal framework are not compromised beyond simply hand absence. Loss of
muscle tissue, permanent nerve damage and phantom limb sensations-pain can all
impact the user’s ability to perform with a prosthesis. In general, a user with a limb
absence where less than 25% of the humerus remains, will not be a good candidate
for using upper extremity prosthetic technology successfully. Additionally, the
user’s cognitive acuity and capability are important in understanding the ranges of
function and the specic limits of function, while controlling such prosthetic tools, to
optimize their performance and avoid injury.
Finally, all prosthetic terminal devices, have inherent dangers of entanglement or
engagement where release can be compromised because of their physical exterior
design, unique unforgiving materials, and inanimate lack of “feel”. Wearing an upper
extremity prosthesis does involve risk! Training and therapy are always recommended
when using a prosthesis, especially when using new or unique technology or changing
prosthetic system operative controls.
2.2 Indications / Contraindications
Mechanical Lock Gripping Devices:
This class of terminal devices is unique in that they provide the ability to manually
lock and unlock around objects, tools and equipment. There is no analog in the
human hand for such function. Such function has inherent benets and risks that
the user must anticipate and understand. Certain activities like vehicle control
should never be used with devices in this class because instant or quick release of
an object or handlebar- steering wheel is not possible. Benets include very stable
control over objects without the liability of releasing or dropping, providing a safety
factor for activities where such function is the primary goal.

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Mechanical Lock Gripping Devices van Fillauer, distributeur Loth Fabenim B.V.
Mechanical Lock Gripping Devices Product Manual
Storage and Handling
3
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.).

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Mechanical Lock Gripping Devices van Fillauer, distributeur Loth Fabenim B.V.
Mechanical Lock Gripping Devices Product Manual
Warnings and Precautions
4
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. 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: These Mechanical Lock Gripping Devices are waterproof to 1
meter; however, if they are submerged, they should be rinsed with fresh
water and dried immediately to remove salt, chlorine, or debris.

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Mechanical Lock Gripping Devices van Fillauer, distributeur Loth Fabenim B.V.
Mechanical Lock Gripping Devices Product Manual
Qualied Provider
5
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.

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Mechanical Lock Gripping Devices van Fillauer, distributeur Loth Fabenim B.V.
Mechanical Lock Gripping Devices Product Manual
Specications and Preparations Before Use
6
Product Name: Black Iron Master & Trainer Series
Applications
Age: Adult: Serious, professional, expert only
Teenage-Adult: All around lifting and training
Limb Description: All Models: Trans-radial & mid-length - long Trans-
humeral
PIVOT MODEL: The pivot model provides for a greater range of motion
through the exercise cycle. This model is not applicable
to wrist disarticulates unless the excess length of the
prosthesis is acceptable.
6.1 Specications
Specications Black Iron
Master Black Iron Trainer
Black Iron
Trainer Pivot
Lenght 3.5 in. (9.0 cm.) 2.6 in. (6.6 cm) 3.5 in. (8.9 cm.)
Width 2.0 in (5.0 cm.) 2.0 in. (5.0 cm.) 2.0 in. (5.0 cm.)
Weight 25 oz. (709 gm.) 15.5 oz. (440 gm.) 18 oz. (511 gm.)
Bar Diameters All models: .875 in. (2.2 cm.) - 1.5 in. (3.8 cm.)
Load Rating 1650 Ibs. (750 kg) 440 Ibs. (200 kg) 440 Ibs. (200 kg)
Color Dark Gray/Black/Silver

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Mechanical Lock Gripping Devices van Fillauer, distributeur Loth Fabenim B.V.
Mechanical Lock Gripping Devices Product Manual
Specications and Preparations Before Use
6
Product Name: Black Iron Lite Series
Applications
Age: Both models Teenage-Adult All around lifting and training
Limb Description: All Models: Trans-radial & mid-length - long Trans-
humeral
PIVOT MODEL: The pivot model provides for a greater range of motion
through the exercise cycle. This model is not applicable
to wrist disarticulates unless the excess length of the
prosthesis is acceptable.
Specications 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. (5.0 cm.)
Weight 11.7 oz. (332 gm.) 13.0 oz (369 gm)
Bar Diameter All models: .875 in. (2.2 cm.) - 1.5 in. (3.8 cm.)
Color Black, Teal, Violet
Product Name: ISHI Archery & Fishing TD
Applications
Age: ISHI for archery and lighter duty freshwater shing, 5-10
years old, bows to maximum 40 pounds.
ISHI HD for heavier hunting bows and for heavier duty
freshwater and saltwater shing.
Limb Description: All Models: Trans-radial & mid-length - long Trans-
humeral
Specications ISHI
Lenght 3.5 in. (9.0 cm.)
Width 3.1 in. (7.9 cm.)
Weight 1.25 in. (170 gm.)
Opening Flexible mandibles accommodate a variety of bow and rod
diameters
Color Stealth Black

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Mechanical Lock Gripping Devices van Fillauer, distributeur Loth Fabenim B.V.
Mechanical Lock Gripping Devices Product Manual
Specications and Preparations Before Use
6
Product Name: Hammerhead
Applications
Age: Teenage through Adult
Limb Description: Trans-radial & mid-length - long Trans-humeral
Specications Hammerhead
Lenght 4.3 in. (11.0 cm.)
Width 2.7 in. (7.0 cm.)
Weight 12.0 oz. (340 gm.)
Opening Accommodates a wide variety of round and shaped kayak
paddle handles
Color Black
Product Name: Multi-D & Multi-D Pivot
Applications
Age: Teenage through Adult
Limb Description: All Models: Trans-radial & mid-length - long Trans-
humeral
Specications Multi-D Multi-D Pivot
Lenght 3.8 in. (9.7 cm.) 4.55 in. (11.6 cm.)
Width 2.0 in. (5.1 cm.) 2.0 in. (5.1 cm.)
Weight 9.6 oz. (272 gm.) 11.4 oz. (323 gm.)
Opening Adjustable diameters: 1.125 in.(2.86 cm.) - 1.750 in. (4.5 cm)
“plus”.
Color Black

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Mechanical Lock Gripping Devices van Fillauer, distributeur Loth Fabenim B.V.
Mechanical Lock Gripping Devices Product Manual
Specications and Preparations Before Use
6
Product Name: Flexible Thing
Specications Flexible Thing
Lenght w/o strap 2.5 in. (6.4 cm.)
Strap Length 12 in. (30.5 cm.)
Width 1.5 in. (3.8 gm.)
Height 1.75 in. (4.4 cm.)
Weight 4.5 oz (128 gm.)
Color Satin Black
6.2 Preparation
Consider the following factors as you determine the most appropriate technology
and prosthesis design for your client:
1. Does the user understand the function and safety features of the devce?
2. What other terminal devices will be used with this prosthesis?
3. In what types of environments will the device(s) be used?
4. In what positions will the person use the device?
5. How will the user switch terminal devices? Will quick-disconnect be helpful?
6. For what other activities might this device be helpful?
7. Will the person benet 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.

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Mechanical Lock Gripping Devices van Fillauer, distributeur Loth Fabenim B.V.
Mechanical Lock Gripping Devices Product Manual
Compatibility
7
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; however, damage caused by other manufacturers wrist units is not
covered under warranty of this device.

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Mechanical Lock Gripping Devices van Fillauer, distributeur Loth Fabenim B.V.
Mechanical Lock Gripping Devices Product Manual
Care and Maintenance
8
General:
Upper Extremity Terminal Devices-End Eectors:
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. They can be immersed in water and washed. If truly
mechanical they should be dried, as thoroughly as possible, and light lubricants can
be applied to moving mechanical linkages as needed. Soap and water cleansing or
rinsing are recommended, especially after operation in environments with a high
quantity of dirt, dust, grit, oils, or solvents. If used in ocean water, cleaning as soon as
possible in fresh water is highly recommended with all devices. Long term exposure
in intense direct sunlight or heat outside of normal use will damage prosthetic
devices that incorporate synthetic rubber in their construction or coverings.
Mechanical Lock Gripping Devices:
These devices employ simple reliable locking type mechanisms. With extended or
heavy use certain parts can wear or deteriorate, so inspect the devices regularly
before each use. Clean as needed. These devices require little if any maintenance.

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Mechanical Lock Gripping Devices van Fillauer, distributeur Loth Fabenim B.V.
Mechanical Lock Gripping Devices Product Manual
Disposal / Waste Handling
9
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.

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Mechanical Lock Gripping Devices van Fillauer, distributeur Loth Fabenim B.V.
Mechanical Lock Gripping Devices Product Manual
User Information
10
The providing health care professional must review the following information
directly with the user.
Consider the following factors as you prepare for this device:
1. Are you able to donn and to do the device independently?
2. Are you able to attach/detach the cable from the device?
3. Are you able to switch terminal devices independently?
4. Are you able to access services from a skilled occupational therapist for
additional training if needed?

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Mechanical Lock Gripping Devices van Fillauer, distributeur Loth Fabenim B.V.
Mechanical Lock Gripping Devices Product Manual
11
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. 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: These Mechanical Lock Gripping Devices are waterproof to 1
meter; however, if they are submerged, they should be rinsed with fresh
water and dried immediately to remove salt, chlorine, or debris.
Warnings and Precautions for the User

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Mechanical Lock Gripping Devices van Fillauer, distributeur Loth Fabenim B.V.
Mechanical Lock Gripping Devices Product Manual
Serious Incidents
12
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.