Life Support Equipment Testing and Modification

Ventilator mods eLife Support Equipment Testing and Modification

The list of commercially-available life support equipment for the hyperbaric chamber is limited, while the advances in technology and the ability to support critically ill patients continues to move ahead rapidly. New technologies imply a great reliance on electronic monitoring and control, and yet the hyperbaric environment still demands that essential fire, mechanical and physiological risks must be effectively mitigated.

Compliance with marketing and sales requirements implies that additional limits are placed on available equipment.

Convergent has the knowledge, experience and resources to effectively assess whether an item of life support equipment is intrinsically safe and functional, or whether it can be rendered so. While the regulatory processes cannot simply be discarded, our consultants can offer ways to ensure compliance, safety, effective functioning and comprehensive operating and maintenance training.

Our process
  • Initial examination of proposed equipment to determine suitability.
  • Presentation of a detailed proposal, including a cost study for client review & approval.
  • Compiling of a user specification to ensure all the needs, functions & expectations are clear, accepted by the parties and documented.
  • Conducting a literature survey and performing an equipment-specific risk analysis.
  • Regulatory compliance assessment to compile a compliance matrix.
  • Development of a modification and testing specification.
  • Performing modifications and conducting detailed testing, usually performed using the client’s biomedical support team, or at a suitable facility where this is not available.
  • External validation of all modifications and test outcomes.
  • Completing of detailed documentation package for client approval.
  • Compiling necessary training and maintenance instructions.
  • All project management and quality assurance activities to ensure full traceability and availability of records for any compliance or regulatory inspections.

 

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