CDU

Philips Electronics (Andover, Massachusetts) last month reported the launch of its HeartStart MRx, a monitor/defibrillator offering a broad range of features and capabilities designed to meet the needs of those providing basic defibrillation, with a panoply of additional features also intended for use by advanced cardiac life support-trained caregivers in the emergency medical services and hospital environments.

Julie Milner, product manager for Philips Electronics, noted that while the initial deployment of the HeartStart MRx might be as a defibrillator, it is "actually much more than an AED." It also is an advanced life support defibrillator/monitor that can be used for a broad range of diagnostics and life support purposes by both emergency medical personnel and hospital caregivers.

"What we are doing," Milner told Cardiovascular Device Update, "is incorporating more than monitoring capabilities in the defibrillator. We are the No. 1 critical-care bedside monitoring company in the world and also the No. 1 AED company in the world. What we've done is marry those two capabilities, from extensive monitoring to AED defibrillation in this device." She said that one of its key features for emergency medical services (EMS) personnel is an especially robust battery power pack for extended monitoring purposes. The device carries two batteries, each providing five hours of battery power to offer 10 hours of monitoring. "That's critical for paramedics in the field when the system's in the back of the vehicle and they can't get to AC power," she noted.

A second key feature for all users is the largest monitor of its kind for this type of device in the industry, Milner said at 8.4 inches in width, at least one-third larger, or more, than other defibrillator/monitors and a color liquid crystal display for easiest reading. What can be read are four waveforms simultaneously: ECG, pulse oximetry, non-invasive blood pressure and end tidal CO2, a measure of the air breathed out by the patient the number of waveforms displayed exceeding all other similar devices in the industry, she said.

"Another feature is a 12-lead ECG. The paramedic can view all 12 leads at once on the display, something no one else can do in their products," Milner added. The advantage, she noted, is that the paramedic does not have to scroll through a long list of waveforms but can view all 12 at once. With this feature, "You've got the whole picture, allowing you to get that information on the display in real-time, quickly telling you what's happening with the patient."

The HeartStart MRx has so many features that one can't help wondering if they will all be understood or even used. Milner answers this by pointing to the device's "scalability." She says that the device can be configured into 16 different packages, with each one enabling a match with the particular way in which it will be used, the needs of the EMS or hospital service provider. "They can buy what they're going to use and what they can put in service," she said, avoiding the problem of buying more than they'll need and unlikely to use.

Overall, Philips describes the defibrillator/monitor as a "two-tiered" device, offering to untrained personnel the ability to use the AED functions, guided by a series of voice prompts, and then, beyond that, providing a broad range of additional features that can be used in the provision of advanced cardiac life support by more highly trained caregivers. In the EMS environment, one of the device's key attributes is ruggedness, Milner says.

In hospital use, the HeartStart MRx is designed with alarms and algorithms that are consistent with Philips' patient monitors and cardiographs and can be used as a crash cart defibrillator, critical care transport monitor, cardioverter, pacer and AED. It is compatible with Philips' family of patient monitors, affording hospital personnel easy patient transitions from a HeartStart MRx to a Philips, Hewlett-Packard or Agilent bedside monitor.

Matching the device's scalability and two-tiered flexibility, Milner says, is its ease of use. "We did extensive usability testing since we didn't want [the device] to be hard to use or its users being anxious or scared," she said. This testing was carried out over more than two years, largely by creating simulators that were provided to different types of caregivers to use and asking them to perform different functions with it. "We asked them to do various tasks without any training shock, pacing, a 12-lead EKG," she said. "We observed how they used the device, observed what was easy, if they navigated the device perfectly or struggled hard to use. We made changes to the simulator, brought it back for retest, and did that to point where we have a device that we know is easy to use. Each mode was tested, each mode was easy to use."

Official rollout of the product came during last month's EMS Expo in Las Vegas, Nevada, with reaction to the product mirroring that of those who have used the device and that of the company's sales people. Users "have really responded to the device's ease of use," Milner said, "and our sales people are excited to get this product in their hands and out to customers."