Have any questions about the InvisionHeart ECG System?

Below are some of our most Frequently Asked Questions about how the system works, our subscription options and more.

About ECGs

What is the difference between an ECG and an EKG?

There is no difference; both ECG and EKG denote an electrocardiogram. According to Wikipedia, the etymology of the word is derived from the Greek electro, because it is related to electrical activity, kardio, Greek for heart, and graph, a Greek root meaning “to write.”

Why is ECG access so important?

Relative to other diagnostic procedures, electrocardiograms are low-cost and non-invasive tests commonly used as a first step in diagnosing cardiac conditions. When it comes to heart disease, “time is tissue.” Minimizing time to treatment is a goal of both the American Heart Association (AHA) as well as the American Medical Association (AMA).

Both organizations are driving protocols to help healthcare systems improve patient care by reducing cycle times. Two recent articles in the professional journals of both the AHA and the AMA have indicated that treatment of ST-elevated myocardial infarction (STEMI) in non-ACS (acute coronary syndrome) in-patients is often worse than for STEMI patients presenting at the emergency room. Ironically, the median time to an ECG for an in-patient was more than 8 times longer and outcomes were much worse than for patients in the ER.

InvisionHeart believes that with better access to high-quality ECG technology throughout the healthcare system, we can make a significant positive impact on the lives of patients as well as their healthcare providers.

The articles referenced are: Acute ST-Elevation Myocardial Infarction in Patients Hospitalized for Noncardiac Conditions
, Xuming Dai, MD; Joseph Bumgarner, MD; Andrew Spangler, BA; Dane Meredith, MPH; Sidney C. Smith, Jr, MD; George A. Stouffer, MD, Journal of the American Heart Association, April 4, 2013. Association of Inpatient vs Outpatient Onset of ST-Elevation Myocardial Infarction With Treatment and Clinical Outcomes, Prashant Kaul, MD; Jerome J. Federspiel, PhD; Xuming Dai, MD; Sally C. Stearns, PhD; Sidney C. Smith Jr, MD; Michael Yeung, MD; Hadi Beyhaghi, MD; Lei Zhou, MD; George A. Stouffer, MD, Journal of the American Medical Association, November 19, 2014 Volume 312, Number 19.

General System Information

What is the InvisionHeart ECG System?

The InvisionHeart ECG System provides healthcare professionals with an efficient and cost-effective means of taking 12-lead electrocardiograms and managing the workflow associated with interpreting and reporting them. It pairs an ultra-compact device with a secure cloud-based data hub that promises to facilitate early cardiac diagnosis and enhance the healthcare provider and patient experience.

How does the InvisionHeart ECG System work?

ECG capture, control and connect are the three primary functions of the InvisionHeart ECG System.

  • ECG Capture: An ultra-compact, battery-powered unit with leadwires and accessories enables a clinician to capture a high-quality resting 12-lead electrocardiogram. This small, portable unit is called the InvisionECG 12-Lead Device.
  • Control: The visual display and control for the 12-Lead Device is a free and intuitive iPad app known as InvisionControl. After ECGs are captured and viewed within InvisionControl, they are exported with wifi or a cellular signal into InvisionConnect, our ECG management platform.
  • Connect: InvisionConnect, our browser-based ECG management platform connects physicians to their patients’ ECG data anytime, anywhere they have internet access. It enables healthcare professionals to read and visually compare, confirm, report, store and manage their ECGs. It also provides notifications via email and SMS.

What makes the InvisionHeart ECG System unique?

Unlike traditional ECG devices and ECG management systems, the InvisionHeart ECG System is designed to operate as an affordable solution that helps optimize access and connectivity.

Affordable: With a small upfront investment and an annual subscription, healthcare professionals can capture and manage ECGs at a fraction of the cost of traditional ECG carts and ECG management systems.

Access: The InvisionECG 12-Lead Device is small enough and inexpensive enough to facilitate having one mounted on virtually every hospital or clinic hallway, so that an ECG is never more than a few steps away. In fact, it is small enough to sit on a desktop or carry in a pocket, so that every healthcare professional may have an ECG at their fingertips.

Connectivity: The secure, browser-based platform enables healthcare professionals to access their patients’ ECGs anytime, anywhere they have internet access with an appropriate browser. No more need to cut, tape, fax or text ECGs to a physician for diagnosis. With improved access and connectivity, the time to treatment should decrease, which can result in better outcomes and improved survival rates with a higher quality of life for many cardiac patients.

What is included in the InvisionECG 12-Lead Kit?

Included in the InvisionECG 12-Lead Kit are one (1) each of the following:

InvisionHeart

  • InvisionECG 12-Lead Device
  • InvisionECG 12-Lead Leadwire Set (leadwires & 10 connector clips)
  • InvisionECG Accessories
    • InvisionECG Charging Cradle
    • InvisionECG Cradle Wall Mount
    • InvisionECG Cradle Power Adapter
    • InvisionECG Service Adapter
  • One starter pack of electrodes (100 count)

Is the InvisionHeart ECG System a monitoring device?

The InvisionHeart ECG System is not a real-time monitoring device, which provides continuously streaming data about a patient’s heart rhythm. It is a device that provides a snapshot in time by capturing 12 seconds of rhythm from 12 different vectors or leads. With the InvisionHeart ECG System, a static image of all 12 leads is rendered for display on an iPad when initially captured or later on any device with an appropriate web browser and internet connectivity.

Where is the InvisionHeart ECG System manufactured?

The InvisionECG 12-Lead Device is manufactured in Nashville, TN. In addition, most of the software developers for InvisionConnect and InvisionControl reside in the Nashville area. We are proud to say that our system is “Assembled in the USA.”

How It Works

What type of ECG does the InvisionHeart ECG System capture?

The InvisionHeart ECG System captures 12-lead resting ECGs.

What is the size of the InvisionECG 12-Lead Device?

The InvisionECG 12-Lead Device is slightly larger than a deck of cards. Its dimensions are 2.8 in (70 mm) x 3.9 in (98 mm) x 1.2 in (32 mm). It weighs only 6.0 ounces (0.17 kg).

InvisionHeart 12 Lead ECG Machine

How does such a small ECG work?

The InvisionECG 12-Lead Device works exactly like a standard ECG device in that it has a leadwire set that uses clips to attach to ten (10) electrodes placed on the patient’s body in a standard ECG configuration. It differs from a standard ECG device in that it doesn’t capture any Personal Health Information (PHI) on the device itself. All PHI is captured in the iPad app called InvisionControl, which also serves as the display and control panel for the device.

What is InvisionControl?

InvisionControl is an easy-to-use, intuitive app that will feel familiar to anyone who has used an iPad. It controls and provides a visual display for the InvisionECG 12-Lead Device.

The InvisionControl app includes the capability to enter patient demographic data (name, medical record number, birthdate and gender). It also provides a tutorial for electrode placement and leadwire validation.

InvisionControl provides a preview of all 12 waveforms as well as the ability to capture a static, diagnostic-quality resting ECG image, which can then be exported to InvisionConnect and/or printed (if an appropriate network printer is available).

What is InvisionConnect?

InvisionConnect is a cloud-based ECG management system that provides the ability to read and visually compare, confirm, report, store and manage 12-lead ECGs captured by an InvisionECG 12-Lead Device.

It is a secure, browser-based healthcare IT platform that provides access to ECGs anywhere and anytime an authorized healthcare professional has web access from an appropriate browser. InvisionConnect is available as a subscription service.

Is the InvisionECG 12-Lead Device wireless?

Yes, the InvisionECG 12-Lead Device connects wirelessly to an iPad via Bluetooth 4.0 technology. However, the system still uses traditional leadwires to make a physical connection with the patient.

InvisionHeart 12 Lead ECG Machine

How do I control the quality of ECGs taken with the InvisionHeart ECG System?

Built right into the system are a number of tools to help drive consistently high-quality ECGs.

First, each lead within the InvisionECG Leadwire Set is color-coded in accordance with American Heart Association (AHA) standards.

Secondly, within the InvisionControl app a user may access a tutorial for ECG electrode and lead placement.

Thirdly, when the system detects good electrode connectivity, each leadwire indicator turns green. A red indicator means there is no connection. An ECG procedure should only commence once all leadwire indicators are green.

Next, the waveform from each lead may be viewed in the InvisionControl app for a quick quality check prior to capturing an ECG.

Lastly, the ECG may be reviewed once it is complete and may be retaken with a minimal number of clicks, if needed.

How rugged is the InvisionECG 12-Lead Device?

The InvisionECG 12-Lead Device was subjected to extensive FDA-required medical device environmental testing to ensure that it can withstand potential damage from daily usage in a clinical environment.

Testing included drop tests, pressure tests and tests for both water and dust ingress. You can feel confident that the InvisionECG 12-Lead Device will keep working even if accidentally dropped on a hard surface or exposed to water.

Note: The InvisionECG 12-Lead Device is rated IP65 in accordance with IEC 60529, Degrees of protection by enclosures (IP Code).

What kind of batteries does the InvisionECG 12-Lead Device use?

The InvisionECG 12-Lead Device uses a rechargeable lithium-ion battery. The InvisionECG Charging Cradle is used to inductively charge the 12-lead device.

It may be placed on a flat surface such as a desktop or attached to a wall with the provided wall bracket assembly. The charging cradle includes a medical grade AC power adapter that connects the InvisionECG Charging Cradle to AC mains power. The charging cradle also includes a USB power connector, which may be used to charge an iPad. (USB cable not included.)

If the lithium-ion battery needs to be replaced, the InvisionECG 12-Lead Device must be returned to InvisionHeart. The device is not field serviceable.

How long can the InvisionECG 12-Lead Device be used before the battery must be recharged?

The battery in the InvisionECG 12-Lead Device lasts for up to 22 hours of non-stop usage when fully charged. If the unit is turned off between procedures, the battery charge may be extended significantly.

How will I know if the battery is fully charged?

When the InvisionECG 12-Lead Device is being paired with the iPad used for ECG capture, a battery charge indicator will appear in the InvisionControl app. A battery symbol and a numerical percentage indicate battery charge level. The Device will slowly blink orange when the battery is less than 20%; it will quickly blink orange when it is less than 10%.

What kind of iPad is required to control the InvisionECG 12-Lead Device?

The following devices are recommended: iPad 4th Generation, iPad Air, iPad Mini Retina 2nd Generation. The primary requirements are the appropriate operating system (Apple iOS 7.1.X+) and a retina display (2048 x 1536 at 326 ppi).

Does the iPad need wifi or a cellular signal to work?

In order to upload your ECGs to the cloud, the InvisionHeart ECG System will need either a wifi signal or a cellular signal to upload those ECGs. However, if no signal is available, the system can cache ECGs on the tablet until a signal is available.

Does each InvisionECG 12-Lead Device require its own dedicated iPad?

No, any iPad that has the InvisionControl app may be used with any InvisionECG 12-Lead Device within your enterprise.

Can I print ECGs from the InvisionHeart ECG System?

Yes, with an Air Printer, you may print ECGs from an iPad using the InvisionControl app. You may also print ECGs from InvisionConnect, the browser-based user interface, provided you have access to a printer from that web browser.

Does the InvisionHeart ECG System include an interpretative algorithm?

At this time, the InvisionHeart ECG System does not include an interpretative algorithm.

Does the InvisionHeart ECG System require proprietary clips or electrodes?

No, the InvisionHeart ECG System uses traditional clips and electrodes. Please refer to the User Manual for approved clips and electrode selections.

Is there a limit to the number of users who can access and use the InvisionHeart ECG system within a healthcare enterprise?

No, InvisionHeart has established a system configuration and a pricing model that is not tied to the number of users. Each user will need a user name and password, but as long as they are credentialed within the system, the number of users is unlimited.

Is there an automatic mechanism for notifying physicians when they need to look at an important ECG?

Yes, when each user is set-up within InvisionConnect, he/she may select email and/or text notifications when:

  • any ECG is exported to InvisionConnect
  • any ECG is marked as Important
  • any comments are added to an ECG.

Once this set-up is established, all ECGs that meet the criteria will be sent to the healthcare provider with a link that allows him/her to immediately access that specific ECG record.

Is the InvisionHeart ECG System cleared by the FDA?

Yes, the InvisionECG 12-Lead Device received FDA 510(k) clearance.

Is the InvisionHeart ECG System HIPAA compliant?

Yes, the InvisionHeart ECG System is HIPAA compliant. No Personal Health Information (PHI) is captured or stored on the InvisionECG 12-Lead Device. PHI that is entered into the InvisionControl app is erased from the tablet after the clinical data is successfully exported to InvisionConnect.

Clinical data is encrypted during transfer and at rest in the InvisionConnect database. In addition, both InvisionControl and InvisionConnect require usernames and passwords at login. Both have timeouts when inactive.

Email and SMS notifications reference records, but don’t contain PHI. Users must be credentialed and authenticated in order to access PHI and view clinical data from email and SMS notifications.

The system was designed so that users may have confidence they are maintaining patient data privacy and security.

How can I be assured of long-term retention and security of clinical data from the InvisionHeart ECG System?

  1. Our InvisionHeart ECG System secures data in a HIPAA compliant storage solution.
  2. Upon request, we can deliver clinical content in a variety of formats such as PDF or DICOM.
  3. Clinical data can be integrated into other ECG management and back office systems.

Integration with Existing Systems

Does the InvisionHeart ECG System interface with my EMR system?

Yes, the InvisionHeart ECG System can interface with your electronic medical record (EMR) system. For an integration fee, we will work with your IT team and your EMR vendor to ensure that your interface works in your specific environment.

I have my own ECG management system, which I plan to retain. Can InvisionECG 12-Lead Devices work with my existing system?

Yes, InvisionECG 12-Lead Devices can work with your existing ECG management system. You will still need an iPad and the InvisionControl app to run your Device.

For an integration fee, we will work with the vendor of your current ECG management system to allow InvisionConnect to serve as an interface engine between InvisionECG 12-Lead Devices and your current system.

Purchasing Information

Where can I buy an InvisionHeart ECG System?

To purchase the InvisionHeart ECG System please contact InvisionHeart directly by phone or via our website. (www.InvisionHeart.com)

If I want to purchase the InvisionHeart ECG System, what do I order?

Each InvisionHeart ECG System includes an InvisionECG 12-Lead Kit along with a one-year subscription to InvisionConnect.

Each InvisionECG 12-Lead Kits includes an InvisionECG 12-Lead Device along with a 12-lead leadwire set with connector clips, charging cradle, power adapter, service adapter, wall mount and a starter pack of 100 electrodes.

You may procure your own iPad or we can build it into the cost of your system. (Note: If you desire an iPad with cellular capability, you will need to work with your local cellular service provider.)

We offer additional options for training, installation and integration.

How much does the InvisionHeart ECG System Cost?

One InvisionHeart ECG System is $2,700.00. It includes an InvisionECG 12-Lead Kit along with a one-year subscription to InvisionConnect. Enterprise pricing is also available upon request.

What is the annual renewal cost of InvisionConnect?

A subscription for InvisionConnect may be renewed for $750.00/year.

What is the cost of the iPad app, InvisionControl?

InvisionControl is available free of charge.

Service and Support

What kind of support does InvisionHeart offer its customers?

InvisionHeart is committed to offering great customer service. While we attempt to make our system as intuitive and user-friendly as possible, we know there are times when additional support is required.

Consequently, we offer installation services, training, integration support and some customization services. In addition, phone support is available from 8 am to 7 pm Central time. After-hours and weekend email support is available as well.

How long is the warranty for the InvisionECG 12-Lead Device?

The InvisionECG 12-Lead Device comes with a 1-year warranty. An extended warranty option is available for purchase.

Does InvisionHeart offer replacement parts?

Yes, InvisionHeart offers individual replacements parts for all items within the InvisionECG 12-Lead Kit, with the exception of electrodes. Replacement parts include:

  • InvisionECG 12-Lead Device
  • InvisionECG 12-Lead Leadwire
  • InvisionECG 12-Lead Leadwire Set (leadwires & 10 connector clips)
  • InvisionECG Charging Cradle
  • InvisionECG Cradle Wall Mount
  • InvisionECG Cradle Power Adapter – NA1
  • InvisionECG Service Adapter

Does InvisionHeart offer a carrying case for its ECG system?

Yes, we offer a carrying case into which all of the elements of the InvisionECG 12-Lead Kit fit perfectly. There is also space for an iPad mini as well as an assortment of electrode clips and electrodes. If you would like to buy this carrying case, please let us know so that we may include it in your quote.

InvisionHeart Carrying Case InvisionHeart Carrying Case