One step on the journey to family — Precision vacuum for ovum aspiration in IVF.
Cook Medical is the largest privately-owned medical device manufacturer in the world and a world-leader in assisted reproduction (IVF). Their products help provide a pathway to family.
Challenge
Design and manufacture a whisper quiet next generation IVF vacuum pump, and provide long-term unceasing engineering support for an ever changing regulatory environment.
The K-MAR-5200 Aspiration Unit™ has been
exported globally for over ten years and is the industry’s IVF aspiration pump of choice.
Sitting quietly in theatre, the K-MAR-5200 delivers the consistent smooth vacuum required by IVF specialists.
The K-MAR-5200 Aspiration Unit™ has been
exported globally for over ten years and is the industry’s IVF aspiration pump of choice.
Sitting quietly in theatre, the K-MAR-5200 delivers the consistent smooth vacuum required by IVF specialists.
An ever changing regulatory landscape.
The regulatory environment for medical devices is constantly evolving and changing. IntelliDesign delivers not only the physical product, but also supports ongoing regulatory compliance activities. Furthermore, for electronic products with a long design life, component obsolescence management is a necessary activity. Proactive component lifecycle management is an essential ongoing engineering activity to ensure continuity of supply.
Quiet, stable pneumatics.
In the interest of positive patient experience, early feedback from IVF clinicians indicated a strong preference for a very quiet product. Noisy equipment can raise patient anxiety, and interrupt patient-to-practitioner communication.
Acoustic muffling is a key property of many of the materials employed in the pneumatic system. Tuned vibration damping keeps the vacuum pump running smoothly and quietly.
Physicians also indicated stability of the vacuum supply was critically important. The microprocessor controller ensures the vacuum system behaves predictably and maintains the user programmed set point.
Project Features
- UL Listed, exported internationally.
- 100% component tracability.
- Embedded firmware and accompanying documentation developed in-house to be compliant with IEC 62304 software safety classification class B and FDA requirements for a software device of moderate level of concern.
- Design and manufacturing under the governance of an ISO13485 quality system.
- Optimised production delivering modest 100’s of unit per year at an economical price point.
- Smooth clean interface with capacity buttons.
- Particular attention given to serviceability and ease of routine maintenance and calibration.
