IngMar Medical ISO 9001:2015 Certified

IngMar Medical is proud to announce that our Quality Management System has been successfully re-certified to ISO 9001 compliance by TÜV Rheinland  (Registration Nr. 74 300 3727). Certification is to the newest version of the standard, ISO 9001:2015.

The scope of registration is the “Design, Manufacture, Calibration, System Training, Consulting and Worldwide Distribution of Respiratory Simulation Devices and Systems.”

“Our certification to the new ISO 9001:2015 means that our customers can rely on our commitment to quality,” said Dr.-Ing Stefan Frembgen, President of IngMar Medical. “We are proud to have reached this milestone a year ahead of required compliance.”

Stefan Frembgen, Dr.-Ing, President, IngMar Medical proudly announces ISO 9001:2015 certification.
Stefan Frembgen, Dr.-Ing, President, IngMar Medical

ISO 9001:2015 is an internationally recognized standard for quality management. Complying with the rigor of this standard helps ensure that customers get consistent, high quality products and services. Annual audits are required to maintain certification.

IngMar Medical’s Calibration Lab is accredited by A2LA to ISO/IEC 17025:2005 (Certificate Nr. 4172.01). To learn more about calibration, click here.

ISO Standards and Requirements for Test Lungs

IngMar Medical’s high-fidelity ASL 5000 Breathing Simulator meets or exceeds the requirements for test lungs used for volume testing as specified in the following standards:

  • ISO 80601-2-12:2011 (Critical Care Ventilators)
  • ISO 80601-2-13:2011 (Anesthetic Workstations)
  • ISO 10651-6:2004 (Home Care Ventilatory Support Devices)
  • ISO 10651-3:1997 (Emergency and Transport Ventilators)

IngMar partners with European calibration & service center

ASL 5000 Breathing Simulator
ASL 5000 Breathing Simulator

The ability to calibrate and service the ASL 5000 Breathing Simulator in a timely and efficient manner is a priority for IngMar Medical. We are pleased to announce that we have partnered with Coretec-Service GmbH in Linden, Germany to service our European customers.

Coretec is accredited to EN ISO 13485:2012 + AC: 2012 (Certificate Nr. Q4N 15 02 66833 005). This means that you can be confident in your results when using your ASL 5000 for research, development, quality testing, and teaching.

The ASL 5000 is a digitally controlled, high-fidelity breathing simulator used in the development and testing of respiratory devices (i.e. ventilators, CPAP, Aerosol Drug Delivery), and by educators to teach the concepts of mechanical ventilation.

Coretec-Service logoTo request calibration and service in Europe, contact Coretec by clicking here.

To learn more about IngMar Medical’s calibration and service offerings, in the US and worldwide, click here.

ASL 5000 User Forum – Join Today!

We love our ASL 5000 users, so in response to requests, we’ve launched an ASL 5000 Breathing Simulator User Forum on LinkedIn! We hope this platform enables our users to collaborate and share everything from teaching techniques, to success stories, to patient models, and more!

The content on this User Forum is intended to be user-generated, with little to no input from IngMar Medical. This is your opportunity, as ASL 5000 users, to meet and converse with other users of the product.

What users are currently discussing on the User Forum…

How do you define ventilator management competency?
How do you determine if a student is competent in ventilator management? Assessing MV proficiency levels can be complicated because there is no standardized rating scale. Some say competency is defined by the student’s comfort level with the ventilator. Others say it’s the ability to identify problems immediately or to have an extensive understanding of human physiology. How do YOU decide whether or not you students are competent in ventilator management?

Click here to join the User Forum and weigh in on the discussion!

 

Is Simulation Training Effective for Ventilator Management?

Residents could touch and manipulate ventilators to develop familiarity and reduce anxiety - without putting patients at risk.
Simulation training lets medical residents practice ventilation management skills…without putting patients at risk.

Simulation training has been shown to be an effective method for medical education. But what about mechanical ventilation management specifically? A recent study at Summa Health System in Akron, Ohio, looked at the effectiveness of a mechanical ventilation boot camp for first year medical residents in surgery and emergency medicine.

The Summa Health study found that the boot camp was effective in increasing competency, knowledge, and confidence with ventilator management.

The three-day training incorporated hands-on scenarios using human patient manikins connected to IngMar Medical’s ASL 5000 Breathing Simulator.

“The ASL 5000 is the only simulator on the market that can manifest the wide variety of pathologic states necessary to provide cutting-edge training to my residents and fellows.“

Rami A. Ahmed, DO, FACEP, Simulation Medical Director, Summa Health System.

In addition to hands-on simulation, other didactic elements were used including: independent reading, a focused PowerPoint presentation, personalized feedback, and a supportive learning environment.

Learners were given identical pre- and post- intervention assessments in the course of the three-day training.

Three-Day Mechanical Ventilation Simulation Curriculum

Day 1: Pre-intervention Evaluation

  • Pre-test confidence survey (5 minutes)
  • Pre-test cognitive multiple-choice exam (25 minutes)
  • Cases and evaluation by critical actions checklist (10 minutes each for 30 minutes total)
    • ARDS
    • Complete lung atelectasis secondary to mucus plugging
    • Pneumothorax in a mechanically ventilated patient
  • Distribution of supplemental readings for independent study (estimated 4 hours of reading)

Day 2: Curriculum and Educational Intervention

  • Case structure:
    • Two to three residents participated in the case (10 minutes)
    • Evaluation by critical actions checklist (evaluated during case)
    • Bedside debriefing by intensivists (20 minutes)
    • PowerPoint presentation review (15 minutes)
  • Pathology reviewed:
    • ARDS
    • Complete lung atelectasis secondary to mucus plugging
    • Altered mental status secondary to overdose
    • Pneumothorax in a mechanically ventilated patient
    • Dynamic hyperinflation

Day 3: Post-intervention Evaluation

  • Post-test confidence survey (5 minutes)
  • Post-test cognitive multiple-choice exam (25 minutes)
  • Cases and evaluation by critical actions checklist (ten minutes each for 30 minutes total)
    • ARDS
    • Complete lung atelectasis secondary to mucus plugging
    • Pneumothorax in a mechanically ventilated patient

Results: 

The post-test evaluation found significant increases in cognitive knowledge, clinical performance, and confidence.

“This study demonstrates the feasibility and effectiveness of a boot camp curriculum for residents on the basics of mechanical ventilation.“

The increase was attributed to numerous factors including the utilization of multiple teaching methodologies to accommodate different learning styles, the supportive learning environment, personalized feedback, and the opportunity for residents to touch and manipulate the ventilators to develop familiarity and reduce anxiety.

Read the full study.

Studying Neonatal CPAP Delivery

How effective is the delivery of neonatal nasal CPAP through a variety of devices? The answer to this question could have a critical impact on the long-term health of a neonate.

Allan Prost at the Southern Alberta Institute of Technology has set out to investigate the effectiveness of the SiPAP, regular oxygen nasal prongs, and specialty prongs like the RAM using the ASL 5000 Adult/Neonatal Breathing Simulator. Read the full story.

New Video Demonstration on Test Automation with the ASL 5000

Answering the needs of our customers working in respiratory device development and manufacturing, IngMar Medical has developed the Test Automation Interface (TAI). The TAI enables users to integrate the ASL 5000 Breathing Simulator into their proprietary systems for automated device testing.

The TAI comprises a set of commands which control the ASL 5000 software from within a separate test software environment (i.e. LabVIEW, C, C++, etc.), a critical prerequisite for automated testing in product development and quality assurance. Multiple ASL 5000 systems can be run on the same CPU. Benefits of the TAI include time savings, accelerated development, and better control over testing protocols. Click here to watch a video demonstration.

Watch the video above to learn how the TAI helps you save time and gain consistency.

Beyond Knobology: A Clinical Flight Simulator for Ventilator Management Training

An interview with Dr.-Ing. Stefan Frembgen, President of IngMar Medical

How did IngMar Medical get involved in ventilator management training?

Dr.-Ing Stefan Frembgen, President, IngMar Medical, Ltd.
Dr.-Ing Stefan Frembgen, President, IngMar Medical, Ltd.

Before establishing IngMar Medical in 1993, I worked in the ventilator industry. IngMar Medical’s flagship product, the ASL 5000™ Breathing Simulator was originally designed for the respiratory device research and engineering community. It has indeed established itself as an essential tool in R&D departments of all major ventilator manufacturers.

However, the ASL 5000’s unique ability to simulate spontaneous breathing in the whole range of patients encountered in the ICU and NICU made it an excellent tool for teaching about managing patients on the more advanced modes available with modern ICU ventilators. Recognizing this, we set out to create a unique system to leverage the power of the ASL 5000 for teaching ventilator management.

Why is there a need for ventilator management training?

At the recent AAMI/FDA Summit on Ventilator Technology, the call for more extensive and consistent training was repeated over and again. A quarter century after the advent of graphics on ICU ventilators, it cannot be said that the potential of this tool is fully understood nor routinely applied. While new modes enable better treatment, they do not necessarily make ventilator management easier. The plethora of names for modes and the lack of user interface standardization create confusion.

This points to the need for a significantly increased depth of education in the art of ventilator graphics interpretation, and the diagnostic and caregiver skills to match. Let us make no mistake: In order to significantly improve outcomes for patients critically impaired in their ability to breathe, more resources, both time and financial, need to be dedicated to teaching the art of ventilator management. Simulation, if done in an efficient way, has the potential to give maximum results with manageable allocation of resources.

What do you mean by efficiency?

Efficiency, from the perspective of an educator, has many aspects:

  • Minimum time to prepare high-impact learning materials and cases
  • Well thought-out integration of simulation sessions into an overall curriculum covering relevant topics of ventilator management
  • Flexibility to adapt materials and scenarios to the level of the students being taught

The RespiSim® System has been designed with all these requirements in mind. It enables the creation of different types of patients and disease states within curriculum designed by leading educators around ventilator management.

Can the RespiSim System be used for competency testing?

The System can be used to simulate nearly any respiratory patient on any ventilator in any mode and to even record data from a multitude of ICU ventilators directly.  It is a tool for education as well as for competency testing.

What is IngMar Medical’s vision for RespiSim?

We would like to give educators a “clinical flight simulator” to enable efficient, immersive learning and competency testing to improve patient outcomes. Another part of our vision for the RespiSim System includes facilitating collaboration within the respiratory care community resulting in time savings for instructors, more consistent training, higher skill levels, and ultimately better patient care.

 

Porcine Lungs Come to Life at UTMB

Porcine lungs powered by the ASL 5000 Breathing Simulator at UTMB
Porcine lungs powered by the ASL 5000 Breathing Simulator at UTMB used to demonstrate recruitment maneuvers.
The following story was shared by Jose Rojas, PhD, RRT, Department of Respiratory Care, University of Texas Medical Branch.

We have been using the ASL 5000™ Breathing Simulator to teach students aspects of pulmonary physiology as it applies to mechanical ventilation. One approach is to integrate the ASL 5000 with human patient simulators that are connected to mechanical ventilators. This approach allows faculty to recreate actual patient scenarios in a safe environment where students can get hands-on experience with the adjustment of ventilator settings and interpretation of ventilator graphics.

The ASL 5000 also allows us to compare the response of different ventilators to similar patient conditions. Students are able to examine features such as tube compensation, flow trigger, and the mixed pressure-volume algorithms.

 

Many of the new generation ventilators have lung recruitment maneuvers that are sometimes difficult to demonstrate with lung simulators. We have been using commercially available porcine lungs (not the result of animal experiments) to enable students to explore the recruitment maneuver features on the Avea and Hamilton G5 and compare these to incremental PEEP increase.Jose Rojas

The use of the porcine lung to demonstrate recruitment maneuvers stimulated us to consider the possibility of using the ASL 5000 to investigate ways to improve protocols for the handling of ex-vivo perfused lungs. We believe this would provide interesting research projects for students and faculty. Many of the current ex-vivo perfusion protocols involve using positive pressure and high concentrations of oxygen to maintain isolated perfused lungs. The longest time that perfused lungs have been kept viable ex-vivo is about 10 hours. Using the ASL 5000 to model breathing, we would like to explore the possibility of extending survival time of ex-vivo perfused lungs. We believe that lowering the FiO2 and avoiding positive pressure ventilation could improve viability. Further development of this model could lead to advances in therapeutics related to airway clearance, mechanical ventilation, and airway pharmacology.

In the video below, the porcine lungs are attached to an Avea ventilator in the CPAP mode (no pressure support) with 10 cmH20 CPAP. The ASL 5000 is set as a single compartment model that is generating approximately 30 cmH20 pressure and programmed to breathe at a rate of 20 breaths per minute.

Do you have an interesting application of your own? Click here to share!

Automated Product Verification at CareFusion

An automated product verification station with the ASL 5000 at CareFusion
Automated product verification station at CareFusion provides efficiency and consistency.

For over a decade, the ASL 5000 Breathing Simulator has been an essential tool for product development and quality control in the respiratory device industry. With the recent development of the Test Automation Interface (TAI), life just got a lot easier for a group of test engineers at CareFusion. The TAI is a feature of ASL 5000 Software 3.4 or later which enables users to integrate the device into their proprietary software for automated device testing.

Mark Blair, Sr. Principal Test Engineer at CareFusion, uses the ASL 5000 for product verification. According to Mark, the use of the TAI in combination with the ASL 5000 “allowed us to automate our product verification test set-ups and data acquisition.” He believes that the time savings and increased efficiency has been extremely beneficial, but he was quick to point out another major advantage of the system.

“The thing this gives us is consistency. It has truly become a pure measurement – always executed and interpreted the same way. You get a repeatable, objective acquisition of the measurements.”

The TAI comprises a set of commands which control the ASL 5000 software from within a separate test software environment (i.e. LabVIEW, C, C++, etc.), a critical prerequisite for automated testing in product development and quality assurance.

Do you have an interesting application of your own? Click here to share!