Reveal LINQ^TMmonitor

This Reveal Linq, the size of two matchsticks, replaces the old Reveal XT monitor which was the size of a computer memory stick and which had to be inserted with a small surgical procedure in a cath lab or operating theatre. The new Linq device is simply injected under local anaesthetic in a procedure room and doesn’t require admission to hospital, sedation, intravenous access or even antibiotics.

The device can be used to diagnose the cause of palpitations or black outs, to detect atrial fibrillation in patients who have suffered a stroke or to confirm success after treatments such as catheter ablation. The device is safe for use in MRI-scanners immediately after implantation.

The Linq is injected under local anaesthetic using a small incision at the lower left chest using a specialised implant tool and takes less than a minute:

The device can be used to diagnose the cause of palpitations or black outs, to detect atrial fibrillation in patients who have suffered a stroke or to confirm success after treatments such as catheter ablation. The device is safe for use in MRI-scanners immediately after implantation.

The Linq is injected under local anaesthetic using a small incision at the lower left chest using a specialised implant tool and takes less than a minute:

The MyCareLink monitor is usually kept in a patient’s bedroom at home, but it also works anywhere in the world where there is a 3G mobile phone signal, so patients can still be monitored on holiday or if travelling abroad on business. Automatic transmissions simply require the patient to be within 2m of the monitor. Once transmitted, this information is only accessible to their doctor via the secure Medtronic CareLink web portal.

Patients can also send information at other times, if they have had symptoms, using the monitor’s digital, animated display that guides the transmission process and confirms information has been sent correctly.

We schedules dates for you to routinely send information from your device to us using your MyCareLink monitor (usually every 3 months)

Device information is also sent automatically for the Reveal Linq device while you sleep if abnormal heart rhythms are detected

Device information is sent automatically from the remote monitor to a secure computer server

I review the device information on a secure website and alert you if there are any problems.

If you feel palpitations or have just passed out, you can use the device activator, or Reveal Patient Assistant, to instruct the device to store information from the previous 7.5-15 minutes (depending on device programming).

The Reveal Patient Assistant is a hand-held, battery-operated device about the size of a deck of cards. When placed over the Reveal Linq device and the button pressed, it triggers the device to store the previous 7.5-15 minutes of your heart rhythm and mark the place on the heart record when your fainting or other symptoms occurred. If successful, a green light illuminates to confirm. Please note, the Reveal Linq device will also automatically record abnormal heart rhythms without you needing to use the Reveal Patient Assist, but it will not store periods of normal heart rhythm when you may have fainted or had other symptoms and that is why it is important to always use the Assistant, if possible.

Also note:

• The Patient Assistant itself does not transmit or store heart information
• The Patient Assistant can be used up to 4 times each day; the 5th time it will overwrite the first patient-saved episode

It is recommended you carry the Patient Assistant at all times. If you can’t get to the Patient Assistant within a few minutes of symptoms, you should simply write down the day and time of these symptoms to share with me at a follow-up clinic.

It is often useful for you to send a manual transmission using the MyCareLink monitor. This ensures all the device’s information is transmitted and clears the device for new information. This is the same process you will need to do when first setting up the monitor or if you take it abroad. Please follow the instructions below for how to do this:

Make sure the MyCareLink monitor is plugged into a power socket.

The MyCareLink will show it is receiving a 3G wireless phone signal by showing a picture of an aerial mast and some blue bars. An arrow will point to the grey button

Press the grey button

Lift up the transmission module

Place the transmission module over your device and watch the MyCareLink monitor screen for the green bar. This shows the device is relaying information.

The module can be replaced in its dock. When the green tick is displayed, the information has been successfully sent to the CareLink portal and will be available for me to examine.

By looking at your heart rhythms before, during and after a fainting spell, I should be able to identify whether the cause of your unexplained fainting is heart rhythm-related. Studies have shown that a Reveal device can diagnose the cause of infrequent, unexplained fainting spells much more often than conventional testing.1

1. Krahn A, Klein G, Yee R, et al. Randomized Assessment of Syncope Trial. Conventional diagnostic testing versus a prolonged monitoring strategy. Circulation. 2001;104:46-51.

If a heart rhythm-related cause is found, I may recommend specific therapy based on the exact cause. If a heart rhythm problem can be ruled out as a cause of symptoms, we can focus on other potential causes.

All surgical procedures carry some risk. As an implantable cardiac monitor is inserted just beneath the skin, there is a small amount of bruising and bleeding and there is a very small risk of infection (less than 1% risk).

Typically, after one or more heart recordings are made during symptoms, I can determine if your symptoms are related to an abnormal heart rhythm. The device can then be removed at that time with a quick and simple procedure. The battery of the Reveal Linq device lasts approximately 3 years, so prolonged periods of monitoring can be performed if needed. If the Reveal Linq device is being used to look for atrial fibrillation after an unexplained stroke, the device will usually not be removed before the battery runs out, or the first episode of AF is detected.

You can continue your normal day-to-day life with a Reveal Linq device. If you experience a fainting spell, the heart monitor will record it. I can download heart rhythm recordings from your monitor to help determine whether you fainted due to an abnormal heart rhythm and to develop a treatment plan.

After implantation

In general, people can perform all their normal activities. It is probably best you avoid strenuous activity for at least a week afterwards. You can swim, bathe and exercise without fear of harming the monitor. Your may be asked to limit some of your activities if you have had fainting spells.

Things to avoid

Electromagnetic fields can potentially interact with the Reveal Linq device. However, these fields are usually weak in most daily surroundings and will not affect the monitor. Strong electromagnetic energy fields may temporarily affect data collection.

Electromagnetic compatibility

Everything that uses electricity produces an electromagnetic energy field. How these energy fields interact with your cardiac monitor is called electromagnetic compatibility. Below are some simple guidelines for avoiding data collection problems related to electrical interference in a few common situations.

Security screening systems

It is unlikely that screening devices at airports or courts will interfere with your device data collection, but they may detect the metal components and set off the alarm. It may be necessary to present your device identification card to obtain clearance. You may wish to be hand-searched instead of going through the security archways.

Mobile phones and other wireless communication devices

Wireless communication equipment includes cordless or mobile telephones, pagers, personal digital assistants (PDAs) or other hand-held computers, wi-fi-enabled laptop computers, and bluetooth devices. These may temporarily interact with the Reveal Linq device and affect data collection.

Device interaction can be minimized by the following:

• Maintain a distance of at least 6 inches between the equipment and the Reveal Linq implant site
• When using a mobile phone, hold it to the ear on the opposite side of your implant site
• Don’t carry the phone or other transmitting device in a pocket on the same side as your Reveal Linq device site or in a shoulder bag near your cardiac monitor – some phones emit signals even when they are not in use

Electronic anti-theft systems

Many retail stores and libraries are equipped with electronic surveillance gates to prevent theft. To reduce the chances of these systems affecting your device’s data collection, avoid prolonged exposure while passing through the gates. Simply walk through these systems at a normal pace.

Home environment

Your Reveal Linq device is not affected by most household electrical equipment such as household appliances, microwave ovens, electrical items for personal care and cleaning, power tools, and home electronics. If you use an induction cook top, you should keep your cardiac monitor at least 24 inches away from the heating zone when the induction cooktop is on. Conventional heating elements do not affect your insertable cardiac monitor collection data.

Industrial equipment

Working with or near certain industrial equipment such as arc welding tools, power plants, transmission lines, and other sources of high electrical current can interfere with the normal data collection of your device. Please let me know if you are likely to be exposed to any of these potential sources of strong electromagnetic radiation.

Medical and dental procedures

Always tell medical and dental personnel you have an implantable heart monitor. Having a Reveal Linq device does not prevent you from undergoing medical and dental procedures. With proper precautions, most procedures are unlikely to interfere with its function. However, some medical procedures may temporarily affect the ability of the device to collect data. Some procedures require your doctor to retrieve information from your cardiac monitor prior to the procedure. These may include:

• Radiotherapy
• Electrocautery or diathermy
• Transcutaneous Electrical Nerve Stimulation (TENS)
• Magnetic resonance imaging (MRI) scans

Can I have an MRI while I have a Reveal Linq device?

Reveal devices have been demonstrated to pose no known hazards in a medical MRI environment. For Reveal Linq devices, there is no MRI waiting period after the insertion procedure. For the older Reveal XT/DX devices, patients must wait 6 weeks after insertion before an MRI to allow sufficient time for wound healing. It is very important you let MRI clinic staff know you have a Reveal device and present your device certification card to them. It is usually best to download information from the device immediately before an MRI scan and then re-check the device immediately afterwards.

For further information please also Medtronic’s MyCareLink website:

https://www.medtronicheart.com/index.htm