PB560 VENTILATOR: OPEN VENTILATOR SELF SERVICE FAQ

Thank you for your interest in design specifications for the Medtronic Puritan Bennett™ 560 (PB560) ventilator. We are unable to respond to individual technical questions, given the increased demands on our team as we ramp up Medtronic ventilator production. The following Self-Service FAQ has been created to answer the most commonly asked questions. Please note that Medtronic is providing this document solely as a resource to third parties interested in independently manufacturing and bringing their own ventilators to market in response to the COVID-19 pandemic. By providing this information, Medtronic is not entering into any cooperative agreement or other arrangements to design, develop, manufacture, test, distribute, sell, or service third-party ventilators.

GENERAL QUESTIONS

Q: Why is Medtronic publicly sharing the design specifications for the Puritan Bennett™ 560 ventilator?
A: We acutely understand the global need for ventilators as life-saving devices in the management of COVID-19 patients. As the U.S. Food and Drug Administration stated in its March 2020 ventilator guidance (“FDA Guidance”), it is necessary to maintain an adequate supply of mechanical ventilators “to support patients who develop respiratory compromise from COVID-19.” Consistent with the FDA Guidance, and in support of the public health and medical response of governmental agencies around the world, Medtronic is making available this package of materials to enable participants across industries to leverage their own expertise and resources to evaluate options for rapid ventilator manufacturing to help doctors and patients dealing with COVID-19.

Q: Will Medtronic provide technical support to organizations and institutions using the PB560 design specifications to build new ventilators?
A: Unfortunately, no. To date, Medtronic has received more than 90,000 registrations for design specifications since we publicly shared them — and we are very pleased with the global response to support the world's need for more ventilators. Unfortunately, we are unable to respond individually to technical questions from organizations that have downloaded the plans, given the time limitations and the increased demands on our team as we ramp up Medtronic ventilator production. You can find additional clarifications and responses from our engineers to frequently asked questions on this page.

Q: What is the process for obtaining the design specifications and necessary software?
A: All interested individuals and organizations can immediately obtain product and service manuals, requirements documents, manufacturing documents, schematics, 3D CAD files, and software source-code files for the PB560 ventilator at medtronic.com/openventilator after agreeing to the terms and conditions of use set out in the Permissive License.

Q: Can anyone access the design specifications?
A: Yes, anyone can access the design specifications at medtronic.com/openventilator after agreeing to the terms and conditions of use set out in the Permissive License.

Q: When did Medtronic make its ventilator design specifications available?
A: Beginning March 30, 2020, Medtronic shared the design files for the Puritan Bennett™ 560 (PB560) ventilator on its website at medtronic.com/openventilator. We have also completed the upload of design, software, and technical files.

Q: Why is Medtronic providing design specifications for the PB560 ventilator rather than the newer PB840, PB980, or Newport™ HT70 ventilator platforms?
A: Ventilator manufacturing is a complex process that relies on a skilled and specialized workforce, an interconnected global supply chain, and a rigorous regulatory regime to ensure patient safety. Indeed, Medtronic sources more than 1,500 components to make PB980 or PB840 ventilators. The PB560 ventilator, by contrast, is a smaller, more compact ventilator that we think will help participants across industries to evaluate options for rapid ventilator manufacturing.

Q: Does Medtronic still make and sell the PB560?
A: Yes, Medtronic sells the PB560 ventilator in 35 countries around the world. Beginning in May, the PB560 ventilator will also be available in the U.S., under an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).

Q: Are all the design, software, and technical files now uploaded on medtronic.com? Who do I contact if I believe files are missing?
A: We have completed the upload of materials to medtronic.com/openventilator. Please note that these FAQs may be updated periodically to answer additional questions as they arise.

TECHNICAL QUESTIONS

Q: Can you share any additional 3-D content for the PB560 ventilator?
A: To provide additional support in the world’s production of ventilators to combat COVID-19, we have created additional 3-D content for the PB560 ventilator in the Jig Workshop app. Jig Workshop is a product of JigSpace Inc., a third-party company that has no affiliation with Medtronic.

The 3-D files available in the Jig Workshop were built by Medtronic’s augmented reality team using models of the PB560 ventilator. The free Jig Workshop app can be downloaded here. From within the app, the PB560 files can be accessed here:

PB560: Assembly Guide (part 1)
PB560: Assembly Guide (part 2)
PB560: Assembly Guide (part 3)

PB560: Single-limb Respiratory Circuit
PB560: Double-limb Respiratory Circuit

PB560: Inlet Air Filter Service 
PB560: Battery Replacement
PB560: Solenoid Replacement

PB560: Power-On Safety Test (POST)

Q: Can Medtronic provide contact information for subcontractors/suppliers? Are we able to purchase subsystems or components?
A: Medtronic suppliers are already at or beyond capacity meeting demand from Medtronic to dramatically increase ventilator production. One of the goals of the open ventilator project is to allow interested third parties to identify additional component suppliers.

Q: Can Medtronic make available molds for the PB560 ventilator or do new molds need to be created?
A: No. All molds are currently in use to maximize current Medtronic production. Additional molds would need to be created specific to ventilators manufactured under the Permissive License.

Q: Can Medtronic service ventilators manufactured under the Permissive License?
A: No. A third-party who manufactures a ventilator under the terms of the Permissive License is solely responsible for the design, manufacture, distribution, installation, performance and service of its ventilator. Medtronic is unable to provide technical or field service for ventilators manufactured under the Permissive License.

Q: Is there a technical support hotline? Can subject matter experts be made available?
A: No. Medtronic is unable to provide technical support beyond the FAQs available on this page and the technical, design, and software documents uploaded to the medtronic.com/openventilator site because of the large volume of requests and our need to focus internal resources on building more ventilators.

Q: Can the Medtronic brand be used on ventilators manufactured under the Permissive License?
A: No, Medtronic brand or trademarks cannot be used. References may be made to Medtronic and PB560 only to the extent required by regulatory authorities.

Q: Can Medtronic make available or sell a working prototype of the PB560 ventilator?
A: No. All existing PB560 ventilators are being directed to patient use in order to meet urgent patient needs.

Q: Can Medtronic help with product testing, make available test fixtures, or tell us how to design test equipment?
A: A third party who manufactures a ventilator under the terms of the Permissive License is solely responsible for the design, manufacture, distribution, installation, performance, and service of their ventilator. However, as a reference, a verification and validation test protocol is available on medtronic.com/openventilator. This includes a detailed description of our test methods and the type of testing equipment used. Otherwise, we are unable to support testing or share detailed designs of test equipment beyond what is already publicly posted.

Q: Can Medtronic make available a video showing how the PB560 ventilator is assembled and how calibration testing is performed?
A: No. We are unable to create new training materials given the increased demands on our team as we ramp up Medtronic ventilator production.

Q: Are there consumables specific to the PB560 ventilator required to operate the ventilator that would also need to be manufactured?
A: Yes. The PB560 exhalation valve is required to operate the ventilator. This component is single-patient use. Medtronic is currently investigating ways to ramp up production of this exhalation valve component. Other consumables used with the PB560 ventilators, such as patient circuits and filters, are available from Medtronic as well as other manufacturers.