Enabling The Future

e-NABLE Device Safety Guidelines Statement

Based on preliminary testing and observations on the functionality and capabilities of our experimental 3D printed prosthetic devices it is felt that they are currently not safe for operation of heavy machinery, tools, equipment, and vehicles due to low grip strength development. These prosthetic devices have shown, however, to provide some functionality for gross grasp activities of light and pliable objects, but it is in no way a substitute for a fully functioning hand. In addition, we don’t recommend the use of our experimental 3D printed prosthetic devices for small children (i.e., under 3 years of age) due to greater fall rate and the need of sensory input through oral stimulation. Furthermore, it is unknown if our experimental 3D printed prosthetic devices are able to sustain a small child’s bite without breaking. Please review and consider the following recommendations and precautions regarding the 3D printed prosthetic device

General Recommendations for experimental 3D printed prosthetic device

Physical Safety

  1. Work with your doctor or medical professional for appropriate use and wearing schedule of your experimental 3D printed prosthetic device.
  2. These devices are made with low temperature plastic and should not be exposed to temperatures over 120° degrees.  A 3D printed prosthetic device left in a car on a hot day may be damaged.
  3. With any prosthetic there is a possibility to develop pressure sores. If redness develops after wearing for the 15-20 minute trial please contact provider of the device, to reevaluate fit. If redness persists please contact your healthcare provider.
  4. Monitor your device for wear and tear and contact your provider for assistance with replacing worn or broken parts.
  5. Users should assume that the device could break at any moment, even while using it for tasks that have worked in the past, because the rate at which the plastic parts fatigue and need to be replaced is unknown.
  6. Do not use the device to lift boiling water off the stove (e.g. cooking pasta) or to lift dishes of very hot food out of a microwave oven or out of a hot oven or any other situation in which a failure of the experimental device could cause injury indirectly if the hot material is dropped or spilled.

Health Safety

  1. Allow the mechanical hand breathing room as excessive sweat and other components may cause poor hygiene and lead to skin problems.
  2. The use of a prosthetic sock is recommended for individuals with sensitive skin.
  3. Make sure you have no allergic reactions to the material used to print the mechanical hand or any other component.
  4. Make sure the mechanical hand is comfortable.
  5. Ensure the mechanical hand is functioning for the correct purpose.
  6. Start using the hand in a progressive manner. If the muscles of your wrist joint are tired, it would be a good idea to take a break and continue using the mechanical hand the next day.

Child Safety

  1. The child needs to be supervised at all times while using these mechanical hands.
  2. Young children cannot be trusted to watch out for the Health Safety items listed above.  It is the responsibility of the caretaker to check for any problems with the child using an experimental 3D printed prosthetic device.
  3. Let the child use/play with the device in a very conservative, progressive schedule:  just 5-10 minutes at a time, or even less.  If the child likes the device and is eager to use it, let them work up to using it for longer periods of time gradually.  Talk with a pediatrician or other medical professional about how much use is safe for the child, and what other problems to watch out for.
  4. If your child feels pain on the wrist or elbow joint, please stop using the mechanical hand. This may be a sign of an overuse injury.
  5. If any component of the mechanical hand breaks, please stop using it.
  6. Ensure that the hardware and other moving parts are not loose, especially for children young enough to be at risk of choking on foreign objects.
  7. The use of the 3D printed prosthetic device should be coordinated with the child’s teacher and health care providers.
  8. The 3D printed prosthetic device is not made for weight-bearing or supporting body weight, so outdoor or rough play with the prosthetic should be closely monitored.
  9. Children who are not walking or are unsteady on their feet may not be appropriate for this device as falling on the 3D printed prosthetic device may result in further injury.

Cleaning instructions:

  1. The 3D printed prosthetic device can be surface cleaned with warm water and a mild detergent.  If an odor develops on the device, cleaning with shaving cream may help to dissipate the odor.  If Velcro straps become worn or ineffective, please contact the provider of your prosthetic hand for replacement.

 

Release and Waiver of Liability and Hold Harmless Agreement

You acknowledge that you understand that the e-NABLE Volunteer Community (“e-NABLE”) is a community of independent volunteers organized to encourage the development and dissemination of prosthetics for children and adults using 3D printer technology.  e-NABLE designs or plans (“Designs”), including the assemblies or component parts (“Components”), are created by individual volunteers and shared under open source licenses. e-NABLE does not certify the Designs or Components operate properly or satisfy any regulatory requirements. This Release and Waiver of Liability and Hold Harmless Agreement (“Agreement”) is meant to reflect the fact that e-NABLE offers these Designs as experimental devices, without warranty of any kind. The person signing below (“You”) is either the individual recipient of the Design or Component if the individual recipient is an adult under the laws of the relevant jurisdiction or the parent or legal guardian of the child if the individual recipient is a child under the laws of the relevant jurisdiction.

You agree that any Design or Component furnished to you by e-NABLE or by any individual associated with e-NABLE is provided “AS IS” and without representations or warranties of any kind, express or implied, and is intended to be a gift. By accepting any Design or Component, you further acknowledge that such Design or Component has not been evaluated or approved by any regulatory authority. Generally, the Design has been developed and produced by one or more members of the e-NABLE volunteer community. These volunteers act independently, without guidance or supervision from e-NABLE.

You understand that any Design or a Component furnished by e-NABLE is meant to benefit an individual recipient who has need of an assistive hand technology, and is not intended, and shall not be used, for commercial use. If you are an adult under the laws of the relevant jurisdiction and are the individual recipient, you acknowledge that you understand the potential risks of the use of the Design or Component and expressly assume such risks. If the individual recipient is a child under the laws of the relevant jurisdiction, you represent that you are the parent or legal guardian of the child and that you understand the potential risks of the use of the Design or Component and expressly assume such risks on behalf of the individual recipient.

Furthermore, you (either for yourself or your child) release and forever discharge e-NABLE and its volunteers (“Releasees”) from any and all liability for acts or omissions— including negligent acts or omissions—causing damage, loss, injury, or death to the individual recipient from the use of the Design or the Component. You agree to defend, indemnify and hold the Releasees harmless from any and all liability or loss—including liability for negligence—arising in conjunction with or resulting from the individual recipient’s use of a Design or Component (including all attorney’s fees and expenses incurred by the Releasees).

You further understand and agree that e-NABLE and any individual associated with e-NABLE shall not be liable for any injuries or damages, including any consequential, incidental, indirect, punitive or special damages, resulting from or arising out of the use of the Design or Component provided by e-NABLE or any individual associated with e-NABLE.

Any information provided by e-NABLE and any individual associated with e-NABLE is not intended to be used or relied upon to diagnose or treat a health problem or disease, and e-NABLE makes no claims regarding the Design or the Components. You should consider consulting with a qualified health care provider prior to fitting the Component. Carefully read all labels and heed all directions and cautions that accompany the Components. Any statements made by e-NABLE are for informational purposes only and are not meant to replace the services or recommendations of a physician or other qualified health care practitioner.

You acknowledge that this Agreement is governed by the laws of the State of Washington (without reference to its conflict of law provisions) and the parties intend that this Agreement be interpreted as broadly and inclusively as permitted by law. If any portion of this Agreement is found to be invalid for any reason, the remainder of the Agreement shall continue to remain in full force and effect and shall continue to be binding.

You have carefully read the foregoing provisions and understand their contents.

18 thoughts on “SAFETY GUIDELINES

  1. Pingback: Robohand義肢自造入門需知 | INNOMAMBO創新曼波

  2. Dave Nearman Reply

    What is the software you use to do the 3d printing? I have 3 grandchildren that I wuld like to teach programming for devices like these.

    • Vaughn Varma Reply

      If you are solely looking to teach them programming, you’d be best off looking elsewhere, honestly (or looking specifically at myoelectric arms, see below). Having worked with some e-nable designers, and having a fair amount of 3D printing experience myself, there is very little of the process for which code does not already exist. 3D modelling or even engineering CAD softwares are used to generate the models, then they are passed through another piece of software to turn them into the necessary commands for the 3D printer. While there is programming work to be done regarding the advancement of this technology (for instance, I am unaware of any software which takes in 3D scanning data, inverts the scan and fits it into a prosthesis which fits the user’s residual limb perfectly, just to name something off the top of my head), but most of this work is fairly complex.

      The only viable option I can personally see in terms of teaching programming within the frame of 3D printed prostheses, is with myoelectric arms. These take electrical signals from the surface of the user’s skin, and can transmit them through a microprocessor, such as an arduino, to a motor or set of motors to activate the fingers electronically. While some programming for devices like these exists already, it is much easier to access the code directly than with the 3D printing aspects of these arms, and so could provide a more suitable framework for teaching programming, provided the rest of the arm is already assembled (that could also be a fun project with the grandkids).

      Lastly, the only other thing I can think of is if you wanted to go in and make extensions for blender that somehow made it easier to produce 3D models of hands; these are written in python, a relatively easy language for beginners to learn, but still require knowledge of how blender works (I think it’d be harder to start here).

      I hope this helps

  3. Frederick E. Smith III Reply

    Hello. I recently lost 3 fingers on 11/22/14 in an industrial accident. I lost my ring, middle and index fingers on my left hand. I have been moved by the children in your post. I myself am 30 years old. I graduated from Marshall university in advanced manufacturing and machinist technologies. I don’t only feel that I can benefit from this technology, I feel as if I can help. I can adapt to not having the use of my left hand, and in less than a week I have accepted that I may never be able to do the things I once took for granted. How can I get involved and start making my own prototype for myself. Once I am able I also wish to help others in my area. As I finish typing this message to you using only one hand just know I come to you as a humble man that realizes change in this world is possible. Please help me help others.

    • Randal KENT Carper Reply

      Frederick,
      My wife and I lived in the Huntington area for 30+ years and have many friends in the area. We are now retired and live in Hertford, NC. I have a BSChE and have joined ENABLE to use my skills to help anyone in need of a prosthesis. I have a Flashforge Creator Pro and have printed a small Cyborg Beast to see how everything works. There are many other more talented people on this site, but I am willing to work with you in whatever capacity you wish.
      I gather that you still have your pinkie and thumb on your left hand. Have you located any designs which have already been adapted to your situation? I have some CAD skills, but do not want to re-invent the wheel. Do you already have access to a printer?
      My printer is probably not large enough to print a hand or gauntlet to fit you.
      Have a good Thanksgiving. I’ll only be sporadically available for about a week, but will try to respond quickly.

      • Warm Fuzzy Revolutionist

        Oh my gosh – What a wonderful message!

        Fred – please fill out the form with your measurements and send that in and Randal – please fill out the form as well if you havent already to sign up to be a fabricator or maker! 🙂 I love this community!!

  4. Deniz viviani Reply

    Hello ,I was born with right hand only.my left hand missing from my wrist.i am from Warwickshire area.please help me to help others

  5. Carol Dilts-Jones Reply

    My glove was caught by a high speed roller chain and I was pulled into a piece of farm equipment. I lost my middle, ring, and pinkie fingers on my left hand, my arm was broken, my ear was taken off, and my scalp was pulled loose before the machine was shut down. This happened at 3:50 pm. Feb. 16 1984. I have raised two sons and have 5 grandchildren with another on the way. I do well enough that most people never notice my missing fingers. I would like to help. If you can learn from my injuries to help someone in the future, great.

  6. Patricia D'Ambrosio Reply

    I am not sure where to discuss my needs. I have fully functioning hands, but I gave up playing piano when my hands did not grow with my body. I have an acquaintance who is a jazz pianist whose hands are also small. He pulled a tendon in his left hand and had to stop playing until it healed. I am wondering if an exoskeleton could be built that would extend the reach for someone who wants to play piano and has small hands.

  7. mai Reply

    Good afternoon
    Please I have a daughter she has 3 years old , she has a arm but no finger expect one finger and she didn’t have nerve in her hand after the elbow .
    My questions is if she can have a function hand or not

  8. Maddie Reply

    Hello! Our class project is to design a prosthetic hand for a little girl, she is about 4-5 and her main reason to want the hand is so she can use the monkey bars. Is this possible?

    • Jen Owen - E-NABLE Post authorReply

      Hello Maddie – unfortunately – children can not use the monkey bars with these hands as they are not strong enough to hold the weight of a child. They can only handle about 2-3 pounds of force before failure so she will not be able to use the monkey bars with the hand but she can use it to help ride her bike or play ball or jump rope and hold onto the swings a little better!

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