FREQUENTLY ASKED QUESTIONS
Product Category
Merlin.net™ Patient Care Network (PCN) 8.0 Q&A
MERLIN.NET ™ PCN 8.0 WEBSITE
Is there a way I can tell if my patient has connected their
transmitter?
Do I need to make any change to the software on my
clinic’s PC to operate Merlin.net™ PCN 8.0?
Yes, the Transmitter link within the patient profile contains the
Last Connection fields. If the transmitter has been set up and
communicating, the transmitter model and serial numbers will be
displayed in the Last Connection section along with the date the
transmitter connected most recently. We expect the Transmitter Last
Updated On date to update on a weekly basis, as the transmitters
update weekly if left connected.
Yes, to operate the Merlin.net Patient Care Network (PCN), the
following must be installed on your PC:
ƒƒ Microsoft™ Windows™ 7, or Microsoft Windows 8 operating system
ƒƒ Modern browsers such as Google Chrome™ or Windows Internet
Explorer™ 10 or above. Windows Internet Explorer 8 and 9 are
also supported but will display reduced performance
Is there a way I can tell if my patient has transmitted
recently?
ƒƒ Adobe™ Acrobat™ Reader 10 software or higher
Yes, there are several ways to tell if there has been a transmission:
ƒƒ Adobe Flash version 11.0 or higher
™
1. Check the Recent Transmissions page.
ƒƒ Java™ Runtime Environment 1.7 (Update 51) or higher
2. A QuickLinks to the messages page where a patient monitoring
report can be found.
ƒƒ For optimal viewing of the Merlin.net PCN, your minimum screen
resolution must be at least 1024 x 768 pixels
3. On the Patient List page, locate the patient and view their Past
Transmissions.
ƒƒ Android or iOS operating systems for smartphones
™
™
ƒƒ Note: Performance issues may result with other configurations
4. On the Patient List page, use the Latest Transmission Date Range
filter to search for transmissions across a certain date range.
Is there a new transmitter required for Merlin.net PCN 8.0?
5. Messages are generated if a transmitter has not been connected
within eight or more days. The last connection field in the patient’s
transmitter page will show the last connected date and time.
No, the Merlin.net PCN 8.0 is a web application upgrade only.
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FREQUENTLY ASKED QUESTIONS | Merlin.net™ Patient Care Network (PCN) 8.0 Q&A
Where can I find the report that tells me a patient’s
Merlin@home™ transmitter is not connected?
SCHEDULED REMOTE FOLLOW-UP AND DAILY DEVICE ALERT
CHECKS—GENERAL
ƒƒ Click the Messages link under QuickLinks; “No Communication
between M@H and M.net in the last 8 days” indicates the patient’s
transmitter is not connected.
How does the scheduled remote follow-up transmission
work?
ƒƒ Messages are generated on a per patient basis.
ƒƒ If the clinic has the schedule enabled (Merlin.net PCN) and
based on the settings in the patient profile, the Merlin@home
transmitter will attempt a device check or scheduled transmission
between the hours of 2 and 4 a.m. If the patient is nearby, the
transmitter will read the device and, if needed, send data to
Merlin.net PCN. The Merlin@home transmitter performs these
tasks quietly; there is no outward notification to the patient that
this is occurring. If the patient was awake, they would only see
the green power light lit.
Who has access to the Two-Factor Authentication and Safe
Harbor at launch?
At the current time, Two-Factor Authentication will be enabled for
clinics in France (Norway in 2014), and Safe Harbor will be enabled
for any clinic in a Safe Harbor−designated country.
What does the white flag designate?
ƒƒ In the event the patient is not nearby, the transmitter makes
repeated attempts at regular intervals until it has communicated
with the patient’s device.
The white flag indicates transmissions with alerts that were migrated
from the previous version of the Merlin.net PCN system. Once these
transmissions with white flags are archived, you will no longer see
new transmissions with white flags.
How long does the transmission last?
ƒƒ Typically with a RF device transmission, the reading stage takes
about 2 to 3 minutes, and the sending stage takes about 10
minutes, so the transmission takes about 10 to 15 minutes
to complete.
Can I sort the DirectAlerts™ notifications on the Recent
Transmissions page?
Yes, you can sort DirectAlerts notifications by alert classification by
clicking on the DirectAlerts column header.
ƒƒ Remember, in most cases, scheduled RF device remote followups take place while the patient is asleep and so the length of the
transmission will not be an issue.
Is free-form text always available for the clinical comment
section?
ƒƒ For patients with inductive devices, the transmission is patient
initiated but the time to complete a remote follow-up from the
device should be about the same.
Yes, the Merlin.net PCN clinic administrator can configure the
type of clinical comments available to users via the Clinic Settings
located in Clinic Administration.
Possible Issues With Scheduled Remote Follow-ups
Is it true I now can archive viewed and unviewed
transmissions?
1. Device wakeup. If the device is not found at the beginning of the
scheduled remote follow-up, the Merlin@home transmitter will
keep trying to connect with the device until successful. There will
be no alarms (sound or lights) on the transmitter; it will simply
keep trying to connect with the patient’s implanted device.
Yes, this feature was introduced with 8.0.
2. Modem. If the transmitter collects information from the
implanted device but is not able to transmit the information due
to a connectivity issue (phone line disconnected, etc.), the
Merlin@home transmitter will reattempt connectivity periodically
throughout the day. If still not successful in establishing
connectivity with the Merlin.net PCN, the Merlin@home
transmitter will generate a Send error (Tower icon lit and
progress LEDs flashing) during the notification window set in the
patient profile. This error indicates to the patient it has not been
able to connect. The patient should push the Start button to
acknowledge the error and reference the troubleshooting section
of the Quick Start Guide or call Remote Care Technical Support
for assistance.
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FREQUENTLY ASKED QUESTIONS | Merlin.net™ Patient Care Network (PCN) 8.0 Q&A
ALERTS
ƒƒ It will only go to the Medical Team if Send to Medical Team is
selected under DirectAlerts Distribution.
Which alerts can cause alert-initiated transmissions?
ƒƒ It is also possible to send to the main clinic contact info, by
selecting any of the radio buttons under the dropdown options,
DirectAlerts Distribution.
Alerts set to Red or Yellow in the patient profile are capable of
generating alert-initiated transmissions.
How can I customize alerts to benefit my patients?
How do I get the Merlin@home transmitter to stop sending
the different alerts?
ƒƒ Clinical Alerts are related to the patient’s condition and thus
should be customized per patient. The customization is done
with a Merlin™ Patient Care System (PCS) that adjusts the trigger
thresholds while the patient is present for an in-clinic follow-up.
The default triggers for these alerts are typically set to a sensitive
setting in the device to ensure that the clinician does not miss
any patient events. For instance, the setting to trigger an AT/
AF Episode Duration is defaulted to an AT/AF that lasts 3 hours.
This setting may not be appropriate for patients with persistent or
paroxysmal AT/AF.
ƒƒ If you do not want the Merlin@home transmitter to generate
an alert for a specific alert type, set the alert type to Off in the
patient profile.
ƒƒ Note: It may take up to a week for the transmitter to obtain any
new settings.
For DirectAlerts™ notifications on the Accent™ and Anthem™
devices, what is the difference between Backup VVI alert
and Device Programmed to Emergency Pacing Values alert?
ƒƒ It is particularly important to customize Clinical Alerts in the
implanted device using a Merlin PCS for patients who are
monitored using Merlin.net PCN. This is because Merlin.net
PCN generates a transmission whenever the implanted device
detects a Clinical Alert. As such, inappropriate alert-triggered
thresholds in the implanted device can result in Merlin.net PCN
transmission.
A device programmed to Emergency Pacing Values is the state the
device is in if the clinician hits the red VVI button on the Merlin™
Patient Care System (PCS). Backup VVI, on the other hand, is a
state the device enters by itself if an error is detected. If the device
is programmed to Emergency Pacing Values, you can get a full
remote transmission through Merlin.net PCN. If a device is in BVVI,
the Merlin@home transmitter will not be able to interrogate the
device, thus only an Alert Summary page indicating the device is in
Backup VVI is available.
ƒƒ The alert triggers can only be customized in the device using
Merlin PCS programmer; however, whether an alert initiates a
remote transmission can be adjusted on Merlin.net PCN. This
customization can be done at the clinic level as well as per patient.
If an alert occurs, we know that notification is sent to the
person at the top of that patient’s Medical Team list. If you
have more than one person listed in that box, will it try the
first person, and if it cannot reach them, try the second
person, then the third, etc? Or does it only contact the first
person on the list?
ƒƒ The alerts displayed on Merlin PCS are designed to notify the
clinician about any potentially important events since the last
follow-up. As such, there is a larger selection of alerts available
on Merlin PCS. In contrast, the purpose of Merlin.net PCN
DirectAlerts notifications is to notify the clinician of any adverse
events that require immediate intervention. As such, DirectAlerts
notifications are a subset of alerts available on Merlin PCS. For
instance, Magnet Reversion alert is available on Merlin PCS
but not as a DirectAlerts notification on Merlin.net PCN. There
are also Merlin.net PCN DirectAlerts notifications that are not
available on Merlin PCS such as High Voltage Therapy Delivered
and Successful ATP. However, once a transmission is uploaded,
all alerts contained within the transmission will be listed on the
Alert Summary, which contains the most comprehensive list of
alerts, DirectAlerts notifications and Merlin PCS alerts. The alerts
section of the FastPath™ software summary provides a list of
Merlin PCS alerts. Please note that all DirectAlerts notifications
are defaulted on, so it is important to customize DirectAlerts
notifications per patient to minimize receiving undesirable alertinitiated transmissions.
ƒƒ Refer to the Alert Management Guide for further details.
ƒƒ An after-hours contact method is selected and entered into the
User’s Profile.
ƒƒ If the first person listed on the medical team does not have an
after-hour’s contact method selected, the Notification Delivery
System will look at the next user profile on the patients’ Medical
Team list.
ƒƒ If none of the users have after-hours contact information listed
in their profile, the alert notification will be sent to the On Call
Physician. On Call Physician information is located in the Clinic
Profile.
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FREQUENTLY ASKED QUESTIONS | Merlin.net™ Patient Care Network (PCN) 8.0 Q&A
MERLIN@HOME™ TRANSMITTER
What is the RF frequency used?
Will an instructional DVD be provided to the patient?
ƒƒ For initial setup (device-transmitter pairing), nightly checks and
patient-initiated follow-ups, the frequency is 2.45 GHz.
Yes, a DVD is packaged with the Merlin@home wireless transmitter,
but not with the inductive Merlin@home transmitters. The package
also includes a User’s Manual and a Quick Start Guide.
ƒƒ For automatic checks, scheduled follow-ups and all data transfers,
the transmitter uses the Medical Implant Communication Service
(MICS) band (402 to 405 MHz), which is a frequency band set
aside for communication with implanted medical devices.
Where is the best place to set up the Merlin@home
transmitter?
If a second family member in the household has an
implanted device, can a single Merlin@home transmitter
be utilized?
The transmitter should be close to the bed and at the same relative
height, with the front facing in the direction of the patient.
No. St. Jude Medical recommends one transmitter per patient since
the transmitter contains specific patient and device information.
What should patients do if they have difficulties setting up
or using the transmitter?
Can the Merlin@home transmitter be reprogrammed once a
patient receives a new device?
ƒƒ Patients should reference the Setup Guide and Quick Start Guide.
ƒƒ For technical support, call 1-877-MY-MERLIN (1-877-696-3754)
or email [email protected].
ƒƒ Yes, the transmitter can be reprogrammed to link to a different
compatible device and does not need to be returned to
St. Jude Medical for reprogramming.
Will call waiting or telephone voicemail features affect the
Merlin@home transmitter?
ƒƒ The patient’s existing Merlin.net PCN profile must be updated
with the correct model and serial number of their newly implanted
device first, and upon being prompted, select Device Change
Out so that the system knows the patient has had a new device
implanted. Once their profile has been updated, you may call the
patient and instruct them to call technical support to manually
synchronize the transmitter to their new device. If the patient has
a Merlin@home transmitter version 6 or above, their transmitter
will automatically resynchronize without any interaction from the
patient. This auto-resynchronization process may take up to a
week after the enrollment is updated, and is dependent upon
the information being input correctly.
No, call waiting should not affect the Merlin@home transmitter.
Stutter tones and, if the transmitter is using a landline connection, a
message on an answering machine will not allow the transmitter to
send a transmission as the device cannot find a normal dial tone.
Is there an option for patients without an analog or DSL
phone line?
Yes, patients can use the Cellular adapter (model EX1151) and the
Broadband Internet Kit (model EX1170).
ƒƒ Note: If the patient had an inductive device and their new
replacement device is RF capable, the patient should be
upgraded to an RF-capable transmitter to take advantage of the
automatic, daily monitoring. Their existing inductive transmitter
can be used for patient-initiated transmissions until their new
RF-capable transmitter is set up.
What is the wireless range of the Merlin@home transmitter?
ƒƒ For initial setup (device-transmitter pairing) and patient-initiated
events, patients should be within arm’s length of the transmitter.
ƒƒ For automatic events, such as daily automatic checks and
scheduled follow-ups, the range is approximately 5 to 15 feet,
but this will vary.
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FREQUENTLY ASKED QUESTIONS | Merlin.net™ Patient Care Network (PCN) 8.0 Q&A
Can the transmitter be unplugged and moved to another
location?
Is the software and firmware supporting the Merlin@home
transmitter upgradeable?
ƒƒ Yes, provided the other location has a compatible phone, cellular
or Internet service (i.e., analog or DSL w/a DSL filter).
Yes, if the transmitter is connected at all times, a weekly maintenance
check is performed to see if there are any software upgrades. If so, it
will perform the upgrades automatically.
ƒƒ The clinic should set the expectation for the patient regarding
when it is all right to leave the transmitter at home (for example,
if vacationing for a few days, as opposed to several weeks).
Should the Merlin@home transmitter be plugged in at all
times?
ƒƒ The clinic should set the expectation for the patient to keep their
transmitter plugged in, when not being moved to another location,
in order to ensure the transmitter can receive profile updates from
the Merlin.net PCN system, and (for RF transmitters) to properly
monitor the patient’s implanted device.
Yes, for optimal results. The transmitter updates itself on a weekly
basis to download the patient’s profile settings (for example, any
changes that were made to the follow-up schedule or DirectAlerts
notification settings).
ƒƒ Patients should be reminded to leave a contact number with their
clinic’s or doctor’s office if they will be away from home during
their scheduled appointment, should it be necessary for the clinic
to contact them.
Is the Merlin@home transmitter compatible with analog
phone lines?
ƒƒ Yes, the transmitter is compatible with analog phone lines. It is
not fully supported but may work with digital services or some
Voice-over-Internet Protocol (VoIP) devices. If the patient also has
DSL service with their phone line, they will need a DSL filter as
indicated in the User’s Manual.
Will there be an international option if the patient travels
outside the US?
Depending on where the patient travels and the duration of
their stay, it may be possible for them to use their Merlin@home
transmitter outside the US. Not all OUS countries have been
approved for remote care. Please have the patient call 1-877-MYMERLIN (1-877-696-3754) to discuss where they will be traveling,
the duration of their stay and the available options. The international
Remote Monitoring information is as follows: call +46 8 474 4147 or
email [email protected].
ƒƒ It is not supported with VoIP nor fully compatible with non-analog
lines.
Is there anything special needed for a sub-pectoral implant?
For a very small group of patients with sub-pectoral implant, i.e.,
deep pocket implants, it may be necessary during initial setup and
any subsequent patient-initiated events, to be even closer to the
transmitter than the arm’s length normally advised. However, for
all automatic transmitter functions such as daily monitoring and
scheduled follow-ups, the 5- to 15-foot wireless range applies.
What is the impact of remote care with the Merlin@home
transmitter on device longevity?
ƒƒ For scheduled remote follow-ups, there is no significant battery
drain above what you would expect to see from regular in-clinic
follow-ups. Note that the transmitter searches for the device,
which helps to maximize device longevity.
Is electronic interference a concern for the Merlin@home
transmitter?
Patients should keep electronic devices away from the immediate
vicinity of the Merlin@home transmitter as they may cause
interference with the wireless RF signal. Even though the transmitter
operates in the MICS band, some consumer electronic items may
still emit signals that overlap the MICS band and interfere with the
signal between the implanted device and the transmitter.
ƒƒ Device longevity will vary depending on the frequency of alerts,
alert conditions and patient-initiated events.
ƒƒ Patients should be advised not to press the white Start button
unless turning off an error alarm or if they are instructed to initiate
a follow-up by their clinic.
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FREQUENTLY ASKED QUESTIONS | Merlin.net™ Patient Care Network (PCN) 8.0 Q&A
What is the Inform Patient/Call Clinic feature and how does
it work?
GENERAL
ƒƒ If the “Inform Patient” feature is enabled for a specific alert in their
patient profile on Merlin.net PCN, and should that alert occur, the
Merlin@home transmitter generates the Call Clinic message.
Will there be 24-hour tech support?
ƒƒ For clinics and allied professionals, the support is 24 hours/7 days
per week.
ƒƒ Stars on the Merlin@home transmitter light up, all five progress
LEDs flash and the transmitter beeps.
ƒƒ For patients the support, Remote Care, is available Monday
through Friday, 8 a.m. to 8 p.m. Eastern Standard Time.
ƒƒ It is recommended this feature be off except in cases where it
is absolutely necessary to alert patients to certain episodes as
soon as possible. When this feature is enabled, patients should
be educated on its use and given instructions on what to do and
who to call should an episode of that type occur.
What are the available ways to contact Remote Care
Technical Support?
Call 1-877-MY-MERLIN (1-877-696-3754) or email
[email protected]
What will happen if the patient presses the Start button on
the Merlin@home transmitter?
What error messages do I need to alert my customers to?
Customers and patients should be referred to the Quick Start Guide,
which provides a list of error messages on the back page.
ƒƒ Patients should be advised not to press the Start button unless
instructed to do so by their clinic or unless it is to turn off an
alarm per instructions in the Quick Start Guide.
ƒƒ If instructed to do so, patients can initiate a manual follow-up by
pressing the Start button twice.
ƒƒ One press wakes up the transmitter.
ƒƒ The second press initiates a reading.
ƒƒ Two consecutive, quick but firm button presses will initiate a
manual transmission.
6
Rx Only
Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
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