MTRs_Artificial.Limbs-Upper.Extremities .docx

B.8 PRODUCT TECHNICAL REQUIREMENTS

I. GENERAL

(a) All prosthetic upper extremities to include, prosthetic terminal device(s), prosthetic wrist unit(s), prosthetic elbow unit(s), prosthetic limb interface systems, and prosthetic limb components and accessories.

(b) Products shall be serialized if that is your commercial practice.

(c) Specific group requirements are listed below. Any exceptions will be noted under the group requirements.

(d) All products must meet ISO-identified standards.

(e) All products must be commercial products as defined in FAR 2.101 in order to be considered for award.

II. DESCRIPTION of Prosthetic Terminal Device, Prosthetic Wrist Unit, Prosthetic Elbow Unit, Prosthetic Limb Interface Systems, Prosthetic Control Systems, and Prosthetic Limb Components and Accessories.

Group 1 (Prosthetic Terminal Device), Group 2 (Prosthetic Wrist Unit), Group 3 (Prosthetic Elbow Unit), Group 4 (Prosthetic Limb Interface Systems), Group 5 (Prosthetic Limb Components and Accessories).

(a) Prosthetic Terminal Device, Prosthetic Wrist Unit, Prosthetic Elbow Unit, Prosthetic Limb Interface Systems, and Prosthetic Limb Components and Accessories shall be fully functional and operational.

(b) Minimum shade/color availability of any product shall match commercial product availability as applicable to the product. Multiple shades may be available.

(c) At a minimum the following items shall be included in packaging:

(1) Product literature must be specific to the enclosed item(s) and its features.

(2) Packaging list/invoice

(3) Patient education materials that allow the patient to maintain or use the device(s) effectively (e.g., instructions on cleaning and maintenance).

(4) Items that allow the patient to maintain or use the devices effectively e.g., cleaning solutions, tools, control devices.

(d) The following shall be included if that is standard commercial practice:

(1) Small tote bags or carry cases, when applicable, shall be included with the device for the patient’s use to carry the device(s), supplies, and literature.

(2) Clinician instructions that will assist the clinician in fitting or instructing the patient in the use of the instrument, small hand tools, electronic tools/devices that assist in programming and alignment, software instructions, fitting instructions, shall be included with the device(s) if that is standard commercial practice. These Clinician instructions, when applicable for the categories, apply to all prosthetic limb terminal devices, prosthetic wrist units, prosthetic elbow units, prosthetic limb interface systems, and prosthetic components and accessories.

(3) Shipping containers shall not include advertising, surveys or questionnaires, cross-selling literature, or insurance offers of any kind.

(4) Products shall have serial number when applicable and as per standard commercial practice.

III. GROUP 1 – PROSTHETIC TERMINAL DEVICE (PTD)

(a) Physical Characteristics: For the purpose of this solicitation/contract, the term PTD shall include prosthetic terminal device for use with endoskeletal and/or exoskeleton prosthetic limb devices. The device is the component of the prosthesis to replace a person’s hand. The PTD shall include either full hand, partial hand with or without digits, and protective cover for all, as applicable products. Group 1 prosthetic terminal device, (full hand or partial hand), shall be available in all commercially product availability and colors.

(b) Product Line: The contractor shall offer all commercially available options which will include active (open and close); and/or passive. May be in a form of a hook, form of a hand with or without digits, (including recreational or activity specific) and may when applicable include a glove covering, when applicable. May be body powered and/or external (electric) powered.

(c) Minimum Technical Requirements for Group 1 PTD Products:

(1) Shall offer all commercial product availability.

(2) Sold per single unit or/as per commercially available packaging.

(3) Cosmetic glove cosmetic glove covering, if applicable.in all commercial product availability and colors.

(4) Include clear care and use instructions.

(5) Shipped in sealed, protective packaging.

(6) Serial and/or product number identified on outside of packaging as per commercial practice and/or as applicable to the product.

(7) Wireless programmability (as applicable to the product).

(8) Shall be fully functional and operational.

(9) FDA approval/exemption: Classification must be identified.

(10) The product shall meet all applicable ISO standards/testing and provide certification documentation.

(11) Written documentation or tracking method of a standardized protocol for recall notices.

III. GROUP 2 – PROSTHETIC WRIST UNIT (PWU)

(a) Physical Characteristics: For the purpose of this solicitation/contract, the term PWU shall include prosthetic wrist unit for use with endoskeletal and/or exoskeleton upper extremity prosthetic limb devices. Group 2 Prosthetic Wrist Unit shall be available in all commercial product availability (e.g., aluminum, stainless steel, titanium, plastic).

(b) Product Line: At minimum the contractor shall offer all commercially available options, which may include Mechanical (e.g., Quick disconnect, flexion/ extension), External powered (e.g., electric wrist rotator), and Passive. The device shall include any and all associated PWU components as applicable to the function and construction of the unit.

(c) Minimum Technical Requirements for Group 2 PKU Products:

(1) Shipped in sealed, protective packaging.

(2) Sold per single unit or/as per commercially available packaging.

(3) Serial and/or product number identified on outside of packaging as per commercial practice and/or as applicable to the product.

(4) The device shall include any and all associated components as applicable to the function and construction of the unit.

(5) Shall be fully functional and operational

(6) FDA approval/exemption: Classification must be identified.

(7) The product shall meet all applicable ISO standards/testing and provide certification documentation.

(8) Written documentation or tracking method of a standardized protocol for recall notices.

III. GROUP 3 – PROSTHETIC ELBOW UNIT (PEU)

(a) Physical Characteristics: For the purpose of this solicitation/contract, the term PEU shall include elbow unit for use with endoskeletal and/or exoskeletal upper extremity prosthetic limb devices.

(b) Product Line: At minimum, the contractor shall offer the following but not limited to: Passive Function; Body Powered; External Powered (electrical or external powered); and/or Hybrid designed PEUs.

(c) Minimum Technical Requirements for Group 3 PEU Products:

(1) Must have a range of sizes matching commercial product availability.

(2) Include clear care and use instructions.

(3) Sold per single unit or/as per commercially available packaging.

(4) Minimum shade/color availability of any product shall match commercial product availability. Multiple shades may be available.

(5) Shall be fully functional and operational

(6) Shipped in sealed, protective packaging

(7) Serial and/or product number identified on outside of packaging as per commercial practice and/or as applicable to the product.

(8) The device shall include any and all associated components as applicable to the function and construction of the unit.

(9) FDA approval/exemption: Classification must be identified.

(10) The product shall meet all applicable ISO standards/testing and provide certification documentation.

(11) Written documentation or tracking method of a standardized protocol for recall notices.

III. GROUP 4 – PROSTHETIC LIMB INTERFACE SYSTEM(S) (PLIS)

(a) Physical Characteristics: For this solicitation/contract, the term PLIS shall include any product that suspends the prosthesis to the patient’s residual limb. Group 4 Prosthetic Limb Interface System(s) Liners and Sleeves shall be available in all commercial product availability.

(b) Product Line: Prosthetic Limb Interface Systems , shall include but not limited to suspension systems (e.g. suction, close fit around the anatomy, harness suspensions, and/or a combination of these), liners and sleeves that the prosthesis that suspends, protects, helps adjust the prosthesis to the patient’s residual limb (e.g. boa type closure system(s), pin, sleeve(s), liner(s) valves, locking and non-locking systems, vacuum, or any other type that fall within the physical characteristics) to the prosthesis.

(c) Minimum Technical Requirements for Group 4 PLIS Products:

(1) Sold per single unit or/as per commercially available packaging.

(2) Include clear care and use instructions as applicable to the product/item.

(3) Shipped in sealed, protective packaging.

(4) Serial and/or product number identified on outside of packaging as per commercial practice and/or as applicable to the product.

(5) Clearly indicate sizing, profile, locking/non-locking as applicable to the product/item.

(6) Clearly indicate the material used in contact with skin when applicable to the product.

(7) Written documentation or tracking method/process of a standardized protocol for recall notices.

(8) FDA approval/exemption: Classification must be identified.

(9) The product shall meet all applicable ISO standards/testing and provide certification documentation.

III. GROUP 5 – PROSTHETIC LIMB COMPONENTS AND ACCESSORIES (PCA)

(a) Physical Characteristics: For this solicitation/contract the term Prosthetic Limb Components and Accessories (PCA) shall include any number of interchangeable components that assists with the assembly/construction and function of the prosthesis.

(b) Product Line: At minimum, the contractor shall offer the following componentry in combination(s) of but not limited to cabling, harness, modular components, control mechanism (e.g., externally battery-powered, wire harness, battery, charger, electric switches or myoelectric signals, pattern recognition), locking or non-locking, pre-made cosmetic glove, endo-skeletal, exo-skeletal, electrodes, may include kits (kits may be sold as a single unit when all parts are required for full functionality of the device).

(c) Minimum Technical Requirements for Group 5 PCA Products:

(1) Commercially available sizing as applicable to the product.

(2) Sold per single unit or/as per commercially available packaging.

(3) Include clear technical instructions.

(4) Shipped in sealed, protective packaging.

(5) Serial and/or product number identified on outside of packaging as per commercial practice and/or as applicable to the product.

(6) Minimum shade/color availability of any product shall match commercial product availability. Multiple shades may be available.

(7) Clearly indicate sizing and/or component adjustability (size range).

(8) Written documentation or tracking method/process of a standardized protocol for recall notices as applicable to the product.

(9) FDA approval/exemption: Classification must be identified (Class 1, 2, 3)

(10) The product shall meet all applicable ISO standards/testing and provide certification documentation.