Customers in the USA

Welcome and thanks for looking at our site.

Much of the information on the site is very relevant to the USA. Many of the statistics on the incidence of heart attacks and strokes comes from the American Heart Association and American Stroke Association's own data. So the rationale for considering having your own heart monitor is compelling.

Although an ECG might sound a complicated test to perform at home, it really couldn’t be much easier. The device itself is simple to fit and use and the software is usually commended for its simplicity and ease. Over 10 years of development went into the design of the MHM 100 service with the goal of making complex ECG testing available and easy for the consumer.

Under the direction of a physician, the MHM 100 can be part of a lifelong, heart-healthy program that may include diet, physical exercise, taking medications as prescribed and getting regular check-ups.

Excerpts from our license submission, which were accepted by the FDA, were:

The MHM 100 Personal Heart Monitor supports the growing need for consumer focused tools to support improved cardiovascular health self awareness among the active ageing US population, as well as any individuals interested in pursuing healthy lifestyles. The MHM 100 monitor is designed to be particularly helpful to those individuals engaged in primary and secondary cardiac disease prevention health regimens including community-based cardiac wellness programs. Self-awareness of the negative and positive effects, respectively, of smoking, caffeine, alcohol and regular exercise on heart rate, for example, can be improved by the availability of personal monitoring aids such as the MHM 100 monitor. The MHM 100 provides more pertinent information to users compared to wrist and chest worn heart rate monitors and is designed to provide professional-quality heart rate monitoring accuracy. In the context of secondary cardiovascular disease prevention, early self-identification of irregular heart rhythms and events may prompt individuals to seek professional medical care earlier and thereby reduce the incidence of arrhythmia- related complications.

Intended Use

The MHM 100 is a portable device used to monitor a person’s cardiac activity. Cardiac measurements, such as heart rate and irregular events, such as tachycardia, bradycardia, ST segment depression, atrial fibrillation, pauses delays, atrial ectopics and ventricular ectopics are captured and displayed on an LCD display or available as a print out. The MHM 100 is not a diagnostic device, but provides ongoing monitoring and recording of cardiac events during a variety of activities, such as resting or exercising in home or fitness centers.

The MHM 100 is easy to use, simple to set up, comfortable to wear and requires no special training to operate. Labelling accompanying the MHM 100 includes directions for use written for the layperson and basic information about cardiac events and general guidelines for seeking professional help.

In the USA, use of the MHM 100 [Regulation Number 21 CFR 870.2800] is governed by the requirements of the FDA and our approval says use of the MHM 100 should be for:

"...in-context monitoring of adult patients where symptoms occur infrequently or where resting ECG monitoring is unlikely to capture symptomatic or asymptomatic abnormal rhythm events."

"Its use includes assessing symptoms (including palpitations, dizzy spells, paroxysmal light headedness and pounding of the heart) that may relate to disturbances of the heart."

"Where it is clinically appropriate the MHM 100 can assist in ongoing monitoring of the frequency of abnormal rhythm events in patients receiving anti-arrhythmic medication or rehabilitation therapy."

You will require the approval of your Physician who needs to write you a prescription to purchase an MHM 100. If you show your physician the indications for use [Click here to print a copy of the indications] they will be able to discuss the benefits of regular monitoring of your condition and how to best use the reports you receive following each test.

We must reiterate that the MHM 100 is not a diagnostic device - it simply monitors the performance of your heart over a maximum 8-hour period. Then the online reports comment on any unusual activity that might require further discussion with your Physician, who will more thoroughly understand your condition. However, this can be very important as in many cases, regular monitoring at home can pick up changes that might otherwise be missed.

For many people the ability to have more control over managing their health in itself is reassuring.

Although we recognize the US health system makes ECG/EKG tests readily available, there is always a cost involved plus the requirement for one or more visits to see your Physician. The MHM 100 allows you to discuss this with your Physician and then test as often as you wish in your own home. We would suggest that any "Green" reports would not require a visit to your Physician, however any "Amber" or "Red" reports should be shared with your Physician - ask for your own Physician's view on this.

Club Medick is your access to our secure web site where your information is stored and is only available for you and your Physician. You will use Club Medick to send test results and receive reports.

Each report is reviewed by two cardiac Physicians from the Quintiles Cardiac Center, the third largest ECG unit of its kind in the World. The reports are focussed only on the ECG and the comments are designed to explain the medical terminology and likely outcomes and treatments. However these comments are generalised, as we cannot know your particular circumstances, as your own Physician can.

That said, most Physicians value the accuracy of our reports and in many cases are able to make very important treatment decisions without further investigation when speed can be critical.

How to buy your MHM 100

Once you have read the information on our web site, you will need to discuss how you think it will help with your Physician. Ideally take a shared visit to our website and show your Physician the MHM 100, what it can detect, that it is endorsed by leading Cardiologists who are well respected in the USA and show the example reports you would be able to share. Please note you will also receive copies of all relevant ECG traces if abnormalities are found. If your Physician is then happy for you to use the MHM 100 he or she needs to write you a prescription.

Then when you come back to our website we need you to complete the "Make a purchase" process where you will need to:

  1. Provide us with the prescription details
  2. Fax a copy of the prescription to our USA distributors, Foxfire Printing on our toll-free fax number (866) 837-5246

Other information specific to our USA customers

Your delivery will be made via Foxfire Printing of 750 Dawson Drive, Newark, DE 19713. We require a minimum of 7 days for credit approval and clearance and will always deliver well within the 30 day limit. Foxfire will also arrange for collection should you need to return the device for any reason as explained in the returns section.

If you have any queries we would ask that in the first instance you should e-mail us with the details and if we cannot solve the issue this way, we will phone you at a pre-arranged time to discuss your problem. You are welcome to phone us at any time during our normal UK working hours but we are aware of the time differences and costs, hence we suggest e-mail as we usually solve most problems this way.

So what are the key points about the information on this site that is different for our USA customers?

  1. You need a prescription from your Physician in line with the indications specified by the FDA.
  2. To comply with our FDA licence, we will need details of your prescription before we can ship your MHM 100.
  3. Delivery will be made from our US distributor, Foxfire Printing, as will returns if required.
  4. Delivery is 30 days, to allow for credit payment requirements, although we usually deliver sooner.
  5. You can call us whenever you wish, but we suggest e-mail will solve most problems and, if required, we will call you at a pre-arranged time at our cost. You can call Customer Support.
  6. The ECG lead colors are different to standard USA ECG leads, but do exactly the same job as long as you place them as shown in the user guide. Many people remember red goes right, green to the ground.
  7. Perhaps the key thing to remember is that use of the MHM 100 could be a very valuable way to help you and your Physician better manage your condition, and in some cases, prevent further serious complications.

Thank you, and stay healthy!