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Medtronic shares PB560 Ventilator specifications, design files, BOM and CAD

Medical device giant Medtronic has recently released specifications and design files for its commercially available PB560 Portable Ventilator in an effort to inspire and support those who are working on their own ventilator designs in the fight against COVID-19. Sharing such detailed information of a commercial product is quite groundbreaking - particularly amongst medical device manufacturers where protection of IP is a high priority. Whether you are working on developing your own ventilator design, such as the OxVent or MIT Emergency Ventilator  (E-Vent) project or not, these files provide an interesting insight into the level of documentation required to manufacture and sell a medical-grade device.

What has been shared?

Since announcing their ambition to share the design Medtronic has released three archives, providing increasingly detailed information. Here is a summary:

Medtronic PB560 Ventilator System – Release 1.0

  • Electrical schematics
  • Manuals
  • Manufacturing documents
  • Requirements documents

Medtronic PB560 Ventilator System – Release 2.0

  • Manufacturing fixtures
  • Printed circuit board drawings (including multiple BOMs)
  • 3D CAD files
  • Mechanical part drawings

Medtronic PB560 Ventilator System – Release 3.0

  • Source code files

Taking a closer look

Requirements

The requirement documents set out detailed specifications for the system. These include performance, control, safety and physical requirements for the device. Below is an excerpt from the Product Requirements Document detailing a block diagram for the ventilation system.

Example of Ventilator Product Requirements

Design

Mechanical CAD, electronics schematics and PCB layouts are also included in the release which provides useful insight into how the ventilator control system works with a combination of electronics and mechanical fail safes.

Blower controller PCB schematic

Assembly

Detailed assembly instructions are included which make up part of the products Quality Management Process. A robust Quality Management System is essential for medical devices manufacturers who must be able to prove that measures are in place to ensure high-quality products can be repeatedly produced at scale. Documented tests and procedures must be followed to ensure all products are safe for use with patients and will continue to work reliably over the products expected lifespan.

Example of the product assembly procedure 

Testing 

Detailed test procedures are described for the product which is used to validate its performance prior to shipping. These testing documents describe the test setup and acceptable bounds for results. 

Example of test procedures

Components

The PB560 is a relatively old design, having been first released in 2010 therefore some of the components listed in the Bill-of-Materials are now difficult to source. The main processor is an ST Microelectronics ST10F276Z5T3, other key components include the Honeywell AWM3300V airflow sensor and Texas Instruments BQ2002CSN battery charge controller.

Firmware

In the latest release, Medtronic has provided full source code files for the device. These might be particularly interesting if you want to know what is required to build software for certified and robust medical devices.

Excerpt of VEN_Compute.c

Let us know what you think!

You can sign up to access the design files from Medtronic here. Take a look and let us know what you think of this bold step by Medtronic in the comments!

Lead Inspiration Engineer @ RS Components and DesignSpark

7 Apr 2020, 7:36

Comments

May 6, 2020 08:04

Hi, Sam - one of the main drawbacks as to prevent people willing to join this Medtronic initiative is the Ventilator's cabinet manufacturing. It could take at least three months to have mould matrix avaliable to the production line. Furthermore does not seem quite fair from Medtronic's side, as to make plans avallable of a discontinued and old model Ventilator, as long many of its parts are no longer manufactured.This being so, could you tell me what is the actual point of this so "dignifying" initiative?

0 Votes

April 29, 2020 12:41

Hi Sam,
We are now trying to make ventilator on our own with the reference design of PB560. But we have a lot of difficult to have the sources of the parts. How can i find direct sourcing or suplier for the parts?

Regards

0 Votes

May 1, 2020 15:01

Hi @WinMoe, I think you will find it very hard to reproduce this design - many parts are custom and will require tooling, also given the age of the design many parts may have now been discontinued. I would recommend using these design files to influence your design approach for a new ventilator design. Thanks, Sam

April 23, 2020 12:39

Hi we are interested in building PB 560 ventilator and have downloaded all the files. I however cannot find any code for the PIC18F43K227 8 bit uP on the Powerpack2 board. I have been through all the files but cannot find any source code for the above device. Maybe the idea is to generate your own code or else they forgot to include the code in the data pack. Your comment would be much appreciated. :)

0 Votes

April 27, 2020 07:22

Hi @ElbertKruger! I'd advise getting in contact with Medtronic directly. They have made a few updates to the release so it may be that there may be more information coming soon.

[Comment was deleted]

April 9, 2020 08:09

Hi Sam thanks for the info.

I have a question, I am interested in seeing the possibility of assembling the PB560. What can be done with the components that are discontinued? Is there a shopping list with components and replacements?. best regards

0 Votes

April 12, 2020 14:18

Hi @ElvinDiaz, I think you might find it very challenging to exactly reproduce this design. Availability of parts is one factor, another consideration is the software and ensuring that you have all of the information required to build and program the software onto the microcontrollers. I would recommend using the archive of information to inform your own approach i.e the code is very useful to understand how they have implemented control systems to regulate the correct conditions, the bill-of-materials gives you an understanding of the standard of sensors that are chosen for these devices and the documentation gives you insight into the process of preparing a device for medical certification.