Safety & Disclaimer
⚠️ This Is a Reference Design, Not a Medical Device
OpenPoleMount is an open-source reference design. It is not a medical device and has not been evaluated, cleared, or approved by the FDA or any other regulatory body.
By printing or using this design, you accept full responsibility for verifying its safety and suitability for your specific situation.
Full Disclaimer
THE OPENPOLEMOUNT DESIGNS, FILES, AND DOCUMENTATION ARE PROVIDED "AS IS," WITHOUT WARRANTY OF ANY KIND. THE OPENPOLEMOUNT PROJECT AND ITS CONTRIBUTORS MAKE NO WARRANTIES AND ACCEPT NO LIABILITY FOR ANY USE OF THESE DESIGNS, INCLUDING BUT NOT LIMITED TO PERSONAL INJURY, EQUIPMENT DAMAGE, OR TREATMENT INTERRUPTION.
See DISCLAIMER.md for the complete legal disclaimer.
Before First Use — Safety Checklist
Work through this checklist every time before mounting medical equipment:
Print quality:
- [ ] Parts printed in PLA with ≥2 mm walls, ≥2 mm top/bottom, ≥15% non-concentric infill (3D honeycomb preferred)
- [ ] No visible layer delamination — parts do not flex or crack under firm hand pressure
- [ ] No significant warping — base and pole channel are flat and straight
- [ ] Thumbscrew threads are clean, smooth, and undamaged
Fit and function:
- [ ] Thumbscrew engages cleanly and holds firm under hand pressure
- [ ] Cradle mounted on pole — does not slide under firm downward push
- [ ] Pump seats fully in the cradle without rocking or side movement
- [ ] IV tubing exits pump without creating tension on the mount
Environment:
- [ ] IV pole base is fully spread and stable on the floor
- [ ] Floor surface is stable (not sloped or slippery)
- [ ] Caregiver or nurse has reviewed the complete setup
Who to Contact
| Question | Contact |
|---|---|
| Pump use and care | Your home health agency or infusion supplier |
| IV pole setup | Your home health nurse |
| Print quality issues | Open a GitHub issue |
| Medical safety questions | Your healthcare provider |
Regulatory Note
In the United States, the FDA regulates 3D-printed objects that are marketed as medical devices. OpenPoleMount publishes open reference designs — it is not marketed as a finished product or medical device.
However, regulations vary by jurisdiction and intended use. You are responsible for understanding and complying with any applicable regulations in your area.
If you are a healthcare professional intending to use this design in a clinical setting, please consult your institution's biomedical engineering department and compliance officer before use.
Last reviewed: 2026-06-08