– If you hear, Shift slightly on pillow, change body position by
making slight movements toward the shoulder opposite where
the sensor is located (i.e., if the sensor is implanted in the left
pulmonary artery (PA), the patient should shift to the right so
the left PA is more centered over the pillow).
– The signal strength bar on the right side of the screen should be
green and at 90% signal strength. This indicates you have a
strong connection to your sensor.
– A yellow signal strength indicates you do not have a strong
connection to the sensor and it is related to the patient’s
position. Have the patient shift slightly on the pillow.
– A blue signal strength bar indicates that the PES is picking up
interference from something other than the sensor. Ensure that
the area around the unit is free of metal objects. See the
Troubleshooting section on back for a list of potential
interferences.
¨
Once the
Measuring… message appears on the screen,
music will begin to play. The patient should remain still and
not speak until the reading is complete. The reading will take
about 20 seconds.
¨
When the reading is finished, you will hear,
Reading
completed, you may get up. Patient can get up at this point.
The screen will display
Reading Successful.
¨
The PES will connect to the Merlin.net
™
PCN to send the
reading. The screen will display
Connecting to send
reading.Once the reading is sent, the PES will also
automatically check for software updates and will
automatically shut down. DO NOT POWER OFF THE PES.
TIPS
• When taking the first reading in the recovery room, walk
through the
Take a Home Reading section of the Patient
System Guide with the patient.
• To experience the most benefit from the CardioMEMS
™
HF
System, it is important that the patient take readings daily or
as instructed by their physician. Taking readings should
become part of their daily routine. It should only take about
2–3 minutes.
• Many patients place the PES on their bed to take their
readings.
• Once turned on, the PES takes a few minutes to warm up for
use.
• There are three options for connectivity for the PES: cellular,
Wi-Fi
‡
or landline. The PES will default to a cellular
connection. There is no cost to the patient for cellular
service.
• If the patient does not have cellular coverage in their area,
they can use Wi-Fi or landline connectivity. Refer the patient
to the QSG for instructions on how to connect to Wi-Fi or
landline in their home.
TROUBLESHOOTING
• If the PES will not connect to the Merlin.net PCN when you
are trying to pair the unit, take the PES to an outside
window to obtain a stronger cellular connection. If you are
still unable to attain connectivity, reference the
Setup-No
Wireless Connection Available section of the Hospital
Electronics System Guide.
• Have the patient hold the handheld unit with the opposite
hand from where their implant is located (i.e., right hand if
sensor is implanted on the left side). This helps to ensure the
patient’s back, where the sensor is located, is flat against the
pillow.
• To avoid interference during a home reading, instruct the
patient to:
– Avoid placing the handheld unit directly on their chest during a
reading.
– Ensure that there are no metal objects near the PES. This could
include jewelry, keys, belts, electric heating blankets, metal bed
frame or rails, or other medical equipment such as a continuous
positive airway pressure (CPAP) machine, hearing aid charger
or oxygen supply.
• Have the patient take slow deep breaths if they are having
trouble getting a strong signal strength. Breathing quickly or
taking really big breaths causes respiratory variability,
making it hard for the system to get a strong signal.
• If the volume needs to be adjusted on the PES, select
Options on the start screen of the handheld unit. Select
Volume and then toggle up or down to increase or decrease.
TECHNICAL SUPPORT
If you have questions on the CardioMEMS™ HF System, please contact Technical Support:
Belgium: +32 2 200 66 95
Denmark: +45 44 50 03 88
France: +33 1 41 46 54 88
Germany: +49 619 6771 1220
Italy: +39 02 3596 1180
Netherlands: +31 318 583 240
Switzerland: +41 442 757 180
UK/Ireland: +44 121 306 055
ABBOTT
The Corporate Village, Da Vincilaan 11 Box F1, 1935 Zaventem, Belgium
Tel: +32 2 774 68 11 | Cardiovascular.abbott
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.
INDICATIONS AND USAGE:
The CardioMEMS™ HF System is indicated for wirelessly
measuring and monitoring pulmonary artery (PA) pressure and heart rate in New York
Heart Association (NYHA) Class III heart failure patients who have been hospitalized for
heart failure in the previous year. The hemodynamic data are used by physicians for heart
failure management and with the goal of reducing heart failure hospitalizations.
CONTRAINDICATIONS:
The CardioMEMS HF System is contraindicated for
patients with an inability to take dual antiplatelet or anticoagulants for one
month post implant.
POTENTIAL ADVERSE EVENTS:
Potential adverse events associated with the
implantation procedure include, but are not limited to, the following: Infection,
Arrhythmias, Bleeding, Hematoma, Thrombus, Myocardial infarction, Transient ischemic
attack, Stroke, Death, and Device embolization.
LIMITATIONS:
Patients must use their own Apple‡ or Android‡ mobile device to receive
and transmit information to the myCardioMEMS™ mobile app. To do so the device must
be powered on, app must be installed and data coverage (cellular or Wi-Fi‡) available. The
myCardioMEMS™ app can provide notification of medication adjustments and reminders,
requests for lab work and acknowledgement that the PA pressure readings have been
received. However there are many internal and external factors that can hinder, delay, or
prevent acquisition and delivery of the notifications and patient information as intended
by the clinician. These factors include: patient environment, data services, mobile device
operating system and settings, clinic environment, schedule/configuration changes, or
data processing.
™
Indicates a trademark of the Abbott group of companies.
‡
Indicates a third-party trademark, which is property of its respective owner.
©
2021 Abbott. All Rights Reserved.
MAT-2105161 v1.0 | Item approved for EMEA Audiences.
