Abbott CardioMEMS HF Manuel - Sayfa 2

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– 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

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

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.

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

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.

• Once turned on, the PES takes a few minutes to warm up for

• There are three options for connectivity for the PES: cellular,

• If the patient does not have cellular coverage in their area,

TROUBLESHOOTING

• If the PES will not connect to the Merlin.net PCN when you

• Have the patient hold the handheld unit with the opposite

• To avoid interference during a home reading, instruct the

PCN to send the

™

• Have the patient take slow deep breaths if they are having

™

• If the volume needs to be adjusted on the PES, select

Germany: +49 619 6771 1220

Italy: +39 02 3596 1180

Netherlands: +31 318 583 240

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.

‡

MAT-2105161 v1.0 | Item approved for EMEA Audiences.

use.

Wi-Fi

or landline. The PES will default to a cellular

‡

connection. There is no cost to the patient for cellular

service.

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.

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.

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.

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.

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.

Options on the start screen of the handheld unit. Select

Volume and then toggle up or down to increase or decrease.

Switzerland: +41 442 757 180

UK/Ireland: +44 121 306 055