FAQ

Clinical Questions

What is the typical usage of this device?

It is used to assess a patient’s respiratory status and to confirm treatment effectiveness. It is used to quickly identify who is hypoxic or not, and if so, what is the severity of hypoxic condition (determined by looking at non-invasive PO2, gPaO2 on the device <80mmHg for example) and severity of impairment is determined by looking at measure like Oxygen deficit and source of that impairment can be determined like looking at PCO2 (PETCO2) and Oxygen Deficit etc. It is used to support ER triage decisions such as do I send a patient home (mild), admit (moderate) and offer intervention (severe) after hospital admission.

What clinical benefit will the AGM100 provide?

The MediPines Gas Exchange Analyzer empowers clinicians with a rapid, convenient way to assess patients’ gas exchange on the spot. An immediately actionable data set is available to support treatment choices by clinicians when dealing with all respiratory and some cardiac cases where impaired gas exchange is present.

How will it be beneficial to our facility?

You can do more with less resources and get it done quickly. You get multiple respiratory measurements in 90 seconds. And you do not need complicated patient effort, expensive tools to narrow down your clinical decisions. The MediPines Gas Exchange Analyzer is portable and designed for point-of-care use in emergence, critical care, and chronic care settings.

How accurate is this device, as it is providing some non-invasive measures?

Outputs measurements consist of direct and indirect calculated measures, and all measures comply with FDA regulated measurement ranges and accuracy to receive US FDA 510k clearance (approval). The accuracy of the output parameters for example gPaO2 and O2 Deficit have been well validated against the current “gold standard” of arterial blood gas and published in peer reviewed articles. The results of these studies show very strong correlation between AGM and invasive blood gas measures with near 1 to 1 relationship. Don’t be too specific but you can quote (R2 = 0.97 and bias of 1.7 mmHg).

What clinical evidence is available?

Feasibility and accuracy research studies have been conducted and results are published in leading peer-reviewed journals, such as CHEST journal.

Operation and Maintenance Questions

Does the AGM100 need to be calibrated?

Not really. AGM has built in automatic sensor calibration before each new patient test, which means there is no calibration a user must do before measuring a patient’s gas exchange.

Does the MediPines AGM100 come with a warranty?

One year warranty. MediPines warrants that the Gas Exchange Analyzer shall be free from defects and materials will perform in accordance with specifications for a period of one year from the date of sale by MediPines or certified distributor to the purchaser. If the product or software fails to perform in accordance with the product specification as described in the manual, MediPines will repair or replace the defective material or parts.

What kind of maintenance is required for the AGM100?

The MediPines Gas Exchange Analyzer has very low maintenance requirements. It is recommended to replace the oxygen sensor every 2 years based on usage; it can be 1 year (heavy usage). The O-ring at the breathing circuit insertion point should be lubricated annually. Additionally, the battery can be replaced if the performance declines. The oxygen sensor and battery can be easily accessed and replaced through the service panel on the back of the AGM100.

What is the typical patient experience (per demo)?

You simply turn on the unit, and apply a single patient breathing circuit, nose clip, and pulse oximeter finger sensor to the patient. Have your patient breathe normally through the mouthpiece, at rest for approximately two minutes. The device outputs all relevant measurements in real time and breathing session results are displayed on the screen. The MediPines Gas Exchange Analyzer (AGM100) system is comprised:

  1. Portable analyzer that is the monitoring unit and reusable pulse oximeter probe which means Equipment purchase good for the duration of typical capital equipment
  2. Single patient use breathing circuit (consumable that is typically purchased at 50 or 100 per order)
  3. Additional accessories that is optional: Pole mount and portable thermal printer as shown.

Future Enhancement Questions

Does the AGM100 work with supplemental oxygen?

No, the AGM100 is currently indicated to be used with room air only. However, this feature is currently in development. If using supplemental oxygen, patients need to be able to safely come off oxygen therapy for a few minutes as determined by their clinician for the test (approximately 3 min for oxygen wash out and gas exchange analysis).

Can the AGM100 be used with mechanical ventilation?

No, however MediPines is currently exploring options to work with ventilator manufacturers to integrate the gas exchange analysis technology into the next generation of mechanical ventilators.

Does the AGM100 integrate with our electronic medical record?

The results from the AGM100 can be saved to an associated USB and/or printed with an integrated printer to be entered into patients’ records. In the next year, AGM product development includes `WiFi and Bluetooth integration into hospital local networks to seamlessly integrate with electronic health records.

Does the AGM100 support continuous monitoring rather than spot check?

Even though the AGM100 has the capability to continuously monitor patients, it was designed for point-of-care spot check measurements.