St. Jude Medical CardioMEMS CM3000 Parts list manual

CardioMEMS™ HF System
Model CM3000
System Guide

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ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, Inc. and its related
companies. © 2014 St. Jude Medical, Inc. All Rights Reserved.

Contents
Description .............................................................................................................................................................. 1
Indications............................................................................................................................................................... 1
Contraindications ..................................................................................................................................................... 1
Warnings ................................................................................................................................................................. 1
Precautions ............................................................................................................................................................. 2
Package Contents .................................................................................................................................................... 2
Sterilization .............................................................................................................................................................. 2
The Patient and Hospital Electronics Systems ........................................................................................................... 3
The Antenna.........................................................................................................................................................................3
Components and Setup............................................................................................................................................ 3
Connect the System Cables ...................................................................................................................................................3
The Printer ...........................................................................................................................................................................4
The Pole Attachment.............................................................................................................................................................5
Hospital Electronics System Password Access ........................................................................................................................5
Take a Pressure Measurement................................................................................................................................. 5
Enter the Patient and Sensor Information ...............................................................................................................................5
Acquire the Sensor Signal......................................................................................................................................................7
Set the Baseline....................................................................................................................................................................7
Take a Reading.....................................................................................................................................................................8
Transfer the Data ..................................................................................................................................................................9
Verify the Patient Setup on the Merlin.net Patient Care Network Heart Failure Management Application..................... 9
Patient Electronics System Setup.............................................................................................................................. 9
Setup with a Wireless Connection.........................................................................................................................................10
Setup without a Wireless Connection....................................................................................................................................11
Patient Training ..................................................................................................................................................... 12
Pulmonary Artery Catheter Setup............................................................................................................................ 13
Take a Follow-up Reading...................................................................................................................................... 13
Retrieve the Patient Information...........................................................................................................................................13
Acquire the Sensor Signal....................................................................................................................................................14
Take a Reading...................................................................................................................................................................14
Transfer the Data ................................................................................................................................................................14
Locate the Sensor Signal ........................................................................................................................................ 14
Optimize the Signal Strength................................................................................................................................................15
Technically Suspect Readings .............................................................................................................................................15
Patient Position...................................................................................................................................................................16
Interference........................................................................................................................................................................16
Troubleshooting the Patient Electronics System ...................................................................................................... 16
Manual Setup Instructions...................................................................................................................................... 17
Hospital Electronics System.................................................................................................................................................17
Patient Electronics System...................................................................................................................................................18
Hospital Electronics System Follow-up..................................................................................................................................18
Additional Hospital Electronics System Functions.................................................................................................... 18
Wireless Connectivity Setup .................................................................................................................................................18
Set the Baseline in a Follow-up Reading...............................................................................................................................18
The Settings Screen ............................................................................................................................................................19
The Admin Screen ..............................................................................................................................................................19
Software Update .................................................................................................................................................................20
Additional Patient Electronics System Functions ..................................................................................................... 20
View the Pressure Values during a Reading ..........................................................................................................................20
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Guidelines for the Management of Hemodynamic Parameters ................................................................................ 21
Elevated PA Pressures (Hyper-volemic).................................................................................................................. 21
Low PA Pressures (Hypo-volemic).......................................................................................................................... 22
Recommended Frequency of CardioMEMS HF System Review ............................................................................... 22
Cleaning................................................................................................................................................................ 22
Storage.................................................................................................................................................................. 22
User/Owner Responsibility ..................................................................................................................................... 22
Electromagnetic Interference and Electromagnetic Compatibility............................................................................. 23
FCC and Industry Canada Statement...................................................................................................................... 25
RTTE Statement .................................................................................................................................................... 25
WEEE Compliance Statement................................................................................................................................. 25
EU REACH SVHC Disclosure.................................................................................................................................. 25
System Specifications ............................................................................................................................................ 26
Electrical Characteristics ..................................................................................................................................................... 26
Mechanical Characteristics.................................................................................................................................................. 26
Environmental Information .................................................................................................................................................. 26
Classification ...................................................................................................................................................................... 26
Testing............................................................................................................................................................................... 26
EMI/EMC Testing ................................................................................................................................................................ 27
Wireless Testing.................................................................................................................................................................. 27
Software ................................................................................................................................................................ 27
Technical Support ................................................................................................................................................. 27
Symbols ................................................................................................................................................................ 27
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Description
The CardioMEMS™ HF System provides pulmonary artery (PA) hemodynamic data used for monitoring in the management of heart
failure (HF). The system measures PA pressure, and the data is used by the physician to initiate or modify heart failure treatment
and manage heart failure.
The system includes the following components:
Implantable wireless sensor with delivery catheter
Patient or hospital electronics system
Patient database
The wireless sensor is designed for permanent implantation into the distal pulmonary artery. Once implanted, the CardioMEMS PA
Sensor provides non-invasive hemodynamic data that is collected in the physician’s office, clinic, hospital, or patient’s home. The
data provided by the system includes:
PA pressure waveform
Systolic, diastolic, and mean PA pressure
Heart rate
This hemodynamic data is transmitted to a secure website that serves as the patient database so that PA monitoring information is
available at all times through the internet. Changes in PA pressure can be used in conjunction with heart failure signs and symptoms
to guide adjustments to medications.
For information on the use of the sensor, please refer to the User’s Manual. For information on the operation of the patient database,
please refer to the Merlin.net™ Patient Care Network (PCN) Heart Failure Management Application Help Manual.
Indications
The CardioMEMS™ HF System is indicated for wirelessly measuring and monitoring pulmonary artery pressure 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.
The CardioMEMS HF System is used by the physician in the hospital or office setting to obtain and review PA pressure
measurements. The CardioMEMS HF System is used by the patient in the home to wirelessly obtain and send hemodynamic and PA
pressure measurements to a secure database for review and evaluation by the patient’s physician.
Contraindications
The CardioMEMS™ HF System is contraindicated for patients with an inability to take dual antiplatelet or anticoagulants for one
month post implant.
Warnings
Before you use the system, read this manual.
Only trained personnel should use this product.
Avoid excessive or damaging force when using the Hospital Electronics System.
The long-term performance of the CardioMEMS™ HF System has not been established.
Do not change the system configuration without authorization from the manufacturer.
If two electronic units are proximate to each other and are used at the same time, pressure measurements may be affected due
to interference between the two systems. In such isolated cases, it is recommended that operation of each electronics unit
occur at separate times.
Two Hospital Electronics Systems may interfere with each other. Only operate one system at a time in the same general vicinity.
Medical Electrical Equipment requires special precautions regarding electromagnetic compatibility (EMC) and needs to be
placed into service according to the EMC information provided. If interference is noted, remove or stop using the interfering
equipment.
The use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold
by the manufacturer as replacement parts for internal components, may result in increased emissions or decreased immunity
of the system.
The use of other attachable parts other than the parts provided may result in inaccurate readings, damage to the system, or
injury to the user. Use only the cables and accessories provided.
The Hospital Electronics Unit should not be used adjacent to or stacked with other equipment. If it is necessary to operate the
unit adjacent to or stacked with other equipment, verify that the system is operating normally in the configuration in which it will
be used.
Other equipment may interfere with the operation of the system, even if the other equipment complies with CISPR emission
requirements. Refer to the Electromagnetic Immunity and Electromagnetic Compatibility section for guidance.
There are minimum amplitudes required for the electronics unit to measure physiological signals. Operation of the equipment
below the minimum amplitudes may cause inaccurate results.
Do not attempt to connect the Hospital Electronics System to any network or data coupling equipment in the hospital other than
those specified.
Follow instructions on shutting down the equipment. Failure to do so may cause file corruption.
While in use, ensure that the power supply is easily accessible since unplugging the device from the outlet is the only means of
completely isolating it from mains.
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Ingestion of any part of the system may cause injury.
Care should be taken to keep all cables away from the neck and face to prevent airway blockage.
If the patient develops redness of the skin or a change in skin sensitivity occurs, they should discontinue use of this product
immediately and contact their physician.
All sensors have a unique calibration. Ensure that readings are only taken using the correct calibration information from the
sensor. Use of the incorrect calibration information may result in an inaccurate reading.
All right-heart catheterizations must be performed under fluoroscopic guidance to prevent sensor dislodgement.
The sensor is visible under plain film X-ray and fluoroscopy. Under CT imaging, there may be localized beam hardening artifact
around sensor implant.
Precautions
Store the system in a temperature controlled, clean and dry area.
Use the system at temperatures between 5º to 40ºC (41º to 104ºF) and 15% to 93% humidity. Store the unit between -25 to
70ºC (-13º to 158ºF), 15% to 93% humidity.
All electronic devices with the system, including components and accessories, are to be used only with the sensor and not with
other products, appliances or devices. If there is evidence of a change in performance, contact Technical Support to obtain
more information.
Avoid excessive or damaging force when using the AC adapter.
Exposure to excess lint or dust may cause the system to malfunction.
The system consists of an electronics unit and an antenna. If any of the following occurs, immediately unplug the electronics
unit and contact Technical Support:
-Any of the cords are noticeably frayed or damaged
-Liquid has spilled onto the monitor, or it has been exposed to rain
-The system has been dropped or the enclosure has been damaged
If you lose the power cord, replace it with an identical cord. Contact Technical Support to obtain a new one.
Only an authorized technician should remove the cover or attempt to service the device. The warranty may be voided otherwise.
Do not place the system near a window. Exposing the LCD screen to rain, water, moisture or sunlight may severely damage it.
Do not apply excessive pressure to the LCD screen. Excessive pressure may cause damage to the display.
Portable and mobile RF communications equipment can affect medical electrical equipment and may cause a malfunction of
the system.
All new or refurbished equipment should be obtained from the manufacturer.
The system may require secure data transfer through the use of the internet or networks. Portions of this internet or network
pathway may become unavailable for periods of time for a variety of reasons including but not limited to: internet connectivity
outage, hardware failure, power outage, or general infrastructure failures. Readings and data that are unable to transmit are
stored and will transmit when connectivity is available.
The mean pressure measurement accuracy of the system may be affected by various factors. In the clinical trial, mean
pressure measurement error was observed when the sensor was deployed in a vessel which had an inner diameter of less than
7 mm, and in cases where there was an acute bend in the vessel of >30 degrees at the location of the sensor. Signs of mean
pressure measurement error include the following:
-Gradual mean pressure changes without a corresponding proportional change in the pulse pressure (systolic-diastolic
pressure)
-Negative mean pressures
If either feature is observed, temporarily suspend use of the pressure information for management of the patient and contact
Technical Support for further assistance. A right heart catheterization may be needed to recalibrate the Baseline (mean
pressure) in order to continue use of the system.
The touchscreen display on the handheld unit can be sensitive to electrostatic discharge (ESD) at high levels. To reduce the
potential for ESD discharge to the touchscreen, remove and hold the plastic handle of the handheld prior to contact with the
touchscreen.
If the touchscreen becomes damaged due to ESD, the screen will be discolored or may be unresponsive. Contact Technical
Support for replacement of the handheld unit.
Please note that high levels of ESD are more likely in situations where the relative humidity is very low, such as inside a heated
building during the winter in areas where it is cold outside. In order to reduce the potential for high levels of ESD, there are
common situations which create static electricity that can be avoided prior to use, for example, putting on and removing
clothes, dragging your feet across a carpet or rug, vacuuming, or removing clothes from a dryer.
The system is not intended to be used in a severe electromagnetic radiation environment or an industrial environment.
The system should not be used in conjunction or in association with Magnetic Resonance Imaging (MRI), computerized axial
tomography (CT), diathermy, Radio Frequency Identification (RFID), and electromagnetic security systems such as metal
detectors.
Package Contents
The system package contains:
Hospital Electronics System
Product documentation
Sterilization
The Hospital Electronics System is provided non-sterile.
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The Patient and Hospital Electronics Systems
The Patient and Hospital Electronics Systems are designed to obtain information from the sensor. The functional components of the
hardware include an electronics unit and an antenna. The antenna simultaneously sends a Radio Frequency (RF) signal to energize
the sensor and measures the RF signal returned by the sensor. This returning signal is processed and stored by the electronics unit.
There are two types of electronics systems: the Patient Electronics System and the Hospital Electronics System. The Patient
Electronics System is the primary means of monitoring. It is used at home by the patient to take regular measurements. The Hospital
Electronics System is used during the implant procedure and when measurements are taken in a clinical setting.
Use a portable pole stand with wheels to mount the Hospital Electronics System. Store the system in the Catheterization Lab area or
the Heart Failure Clinic.
Figure 1. The Hospital Electronics Unit
1. Thermal printer
2. Touchscreen
3. USB ports
The Antenna
The antenna attached to the Hospital Electronics Unit is designed for ease of use during the implant procedure and for follow-up
measurements in the hospital or clinic. The antenna communicates with the sensor and is connected to the unit by a custom cable
with a locking connector. The antenna uses RF energy to power the sensor. When the sensor is energized, it returns an RF signal.
The antenna receives the signal and sends it to the electronics unit for processing into a pressure waveform.
The arrows on the antenna control the Search pressure, and the green square lets you take a reading.
You can leave the antenna attached to the electronics unit at all times, if desired. The serial number on the antenna and the
electronics unit must match.
Figure 2. The Antenna
Components and Setup
Connect the System Cables
To connect the system cables:
1. Align the keyed antenna at an approximately 30 degree angle and twist the locking connector.
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Figure 3. Connect the antenna
2. Attach the connectors as shown in the figure below.
You can connect an optional VGA cable to the auxiliary VGA connector.
Figure 4. The connectors
1. Power switch
2. Power cable (5 pin DIN)
3. Printer serial cable (9 pin D-SUB)
4. VGA connection
5. Printer power cable
3. Plug the power cord into the power supply and plug the power cord into the wall.
The Printer
The printer clips into the mount on the front of the electronics unit as shown in the figure below.
Figure 5. The printer mount
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The Pole Attachment
To mount the electronics unit to a pole, use the pole clamp. Follow these guidelines:
Use a pole1that is sturdy, has locking wheels, and can remain stable at an incline of 10 degrees.
If the pole is on an incline, it may experience an initial settling movement before it stabilizes. Maintain control of the pole until it
stabilizes.
Keep the pole at its lowest height setting.
Figure 6. The pole clamp
1. Pole clamp
Hospital Electronics System Password Access
By default, new Hospital Electronics Systems require you to enter a Merlin.net PCN username and password before you can use the
system. This protects the privacy of patient information. If the system is in a secure area, and you are a Merlin.net PCN
administrator, you can disable the Password Entry screen from the Settings screen.
If you are unable to gain access with the password, you can obtain a temporary password on the My Account page on the Merlin.net
Patient Care Network Heart Failure Management Application. To access the system after you obtain a temporary password:
1. Enter your username and password on the User Log On screen.
2. Select the OK button.
The system attempts to connect to the network.
3. Select the Cancel button.
The system logs you in.
If you are unable to log in, contact Technical Support for additional assistance.
Take a Pressure Measurement
This section explains how to take a pressure measurement of a newly implanted sensor with or without a wireless connection to the
Merlin.net Patient Care Network Heart Failure Management Application. A manual option is available as a backup method. Refer to
the Manual Setup Instructions section for instructions.
All of the Hospital Electronics Systems are equipped with cellular antennas, and Wi-Fi™2is an available accessory.
For an accurate sensor measurement, verify that the pulmonary artery catheter is set up properly. Refer to the Pulmonary Artery
Catheter Setup section for instructions.
Enter the Patient and Sensor Information
With a Wireless Connection
Before the first sensor implant procedure of the day, use the website to enter the patient information for all of the patients that will
receive a sensor on that day. Refer to the Merlin.net Patient Care Network Heart Failure Management Application Help Manual for
details.
Each sensor has unique characteristics that you must load into the system. The sensor information is stored on a USB flash drive
inside the sensor package.
To enter the sensor information:
1. Insert the USB flash drive from the sensor package into the USB port.
1A recommended pole is Pryor Products, Inc. #135.
2Wi-Fi is a trademark of the Wi-Fi Alliance.
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Figure 7. The New Implant button
2. Select the New Implant button.
The list of patients you entered on the website appears on the screen.
3. Select a patient from the list and then select the OK button.
After the sensor information loads, it appears on the screen along with the patient information.
4. Verify that the patient information is correct.
5. Verify that the senor serial number matches the serial number on the sensor box.
Without a Wireless Connection
To enter the patient and sensor information:
1. Insert the USB flash drive from the sensor package into the USB port.
Figure 8. The New Implant button
2. Select the New Implant button.
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Figure 9. The Demographics screen
3. Enter the patient information using the touchscreen keyboard.
To modify a field, touch the desired field. Make sure you fill out the first and last name fields and the birthdate field. The phone
number field is optional. All of this information appears on the website once the implant is complete.
4. Select the OK button.
The Verification screen appears.
5. Verify that the patient information is correct.
6. Verify that the sensor serial number matches the serial number on the sensor box.
Acquire the Sensor Signal
After you have implanted the sensor and entered the patient and sensor information into the system, follow the steps below.
1. Place the antenna under the patient's back on the same side as the sensor.
2. Position the center of the antenna under the tip of the patient's shoulder blade on the same side as the sensor.
3. Check the signal strength.
If the signal strength (SS) bar is optimal (>70% and a green color), proceed to the Set the Baseline section below. If not, refer to the
Optimize Signal Strength section.
Set the Baseline
Initially, the pressure values on the right of the waveform appear as dashed lines. This indicates that the PA pressure baseline is not
set.
Figure 10. The initial pressure waveform
To set the PA pressure baseline value:
1. Wait for the screen to fill with a stable pressure waveform and then select the Set Pressure Baseline button.
2. Enter the mean pressure from the pulmonary artery catheter measurement and then select the OK button.
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Figure 11. The Pressure Baseline screen
3. Wait for the screen to refill with a stable pressure waveform and then confirm that the sensor mean pressure matches the
catheter PA mean pressure within +/- 1 mmHg.
Repeat this step as necessary to achieve a good match between the measurements.
4. Confirm that the height of the sensor signal pressure (systolic - diastolic) is within +/- 25% of the height of the catheter
pressure.
If necessary, set the PA pressure baseline again.
After you set the PA pressure baseline, you have the option to set the cardiac output (CO) baseline. To set the CO baseline, you
need a reference value for the cardiac output. This can be either thermodilution or modified Fick. The steps to set the CO
baseline are as follows:
5. Select the Set CO Baseline button.
The system indicates that the baseline data is being collected and prompts you for the reference cardiac output once finished.
6. Enter the reference cardiac output value and then select the OK button.
Once you are satisfied with the PA pressure baseline, take as many pressure readings as desired. Establishing an accurate PA
pressure baseline at the time of implant is important to ensure accurate PA pressure readings from home.
Take a Reading
To take a reading after the baseline is set:
1. Select the Take Reading button on the Pressure Baseline screen to capture the pressure measurements.
The following screen appears.
Figure 12. The Reference Values screen
2. If desired, enter the catheter values and then select the OK button.
The comparative PA catheter pressure values are optional. They are used to visually check that the PA pressure values have the
proper baseline and amplitude.
The captured reading appears on the screen for confirmation. The colored horizontal lines indicate the catheter pressure values
you entered as reference. The green line indicates the systolic pressure, the blue line indicates the mean pressure, and the red
line indicates the diastolic pressure.
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Figure 13. The PA catheter pressure reading
3. If the reading is acceptable, select the Yes button. If not, select the No button and repeat the reading.
4. Reconfirm that the sensor mean pressure matches the catheter PA mean pressure within +/- 1mmHg.
Check the setup and if necessary, set the PA pressure baseline again to achieve a good match between the measurements.
5. Reconfirm that the height of the sensor pressure signal (systolic - diastolic) is within +/- 25% of the height of the catheter
pressure.
Check the setup and if necessary, set the PA pressure baseline again to achieve a good match between the measurements.
Transfer the Data
With a Wireless Connection
Once the readings are complete, the data is automatically transferred to the website. After the data is transferred, the system checks
for software updates. Refer to the Software Update section for more information.
1. Select the Exit button from the Data Acquisition screen.
2. If desired, select the Print button.
Without a Wireless Connection
Once the readings are complete, you must manually transfer the data to the website. To transfer the data:
1. Select the Exit button from the Data Acquisition screen.
2. Save the data to a USB flash drive.
3. If desired, select the Print button.
4. Insert the USB flash drive into the USB port of the computer.
5. On the website, select the Add Patient button and then the Import From Flash Drive button.
Verify the Patient Setup on the Merlin.net Patient Care
Network Heart Failure Management Application
The Merlin.net™ Patient Care Network Heart Failure Management Application is the primary place to view the status of your patient.
After the implant, confirm that your patient has been properly set up on the website.
The following information is updated on the website after the implant:
The patient and medical institution information. The patient information is only visible to users associated with your medical
institution.
The baselines and readings from the implant procedure. This allows accurate trending once your patient begins to take
readings at home.
Refer to the Merlin.net Patient Care Network Heart Failure Management Application Help Manual for specific website setup
instructions.
Patient Electronics System Setup
After you set up the website, set up the Patient Electronics System with the following:
Patient information
Sensor information
Baseline information
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The two options for the setup are:
From the website using wireless connectivity
From the electronics unit using a USB flash drive
A manual option is available as a backup method. Refer to the Manual Setup Instructions section for instructions.
Figure 14. The Patient Electronics System
Setup with a Wireless Connection
Most Patient Electronics Units have cellular modems. If wireless connectivity is available, follow the steps below.
After you start the system, the following screen appears.
Figure 15. The Select Language screen
1. To select the language, press the Next button until the desired language appears and then press the Select button.
Figure 16. The Select Country screen
2. To select the country, press the Next button until the desired country appears and then press the Select button.
If you plan to use a landline connection, it is important that you select the correct country.
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Figure 17. The Serial Number screen
3. To enter the the 6 digit serial number located on the patient's identification card, select the Enter button and then type in the
serial number using the touchscreen keyboard.
Figure 18. The Verification screen
4. Verify that the patient information and the sensor information is correct.
When the system is successfully set up, the system displays the patient’s name above the Start button.
Setup without a Wireless Connection
Wireless connectivity may be unavailable for the following reasons:
The system has a dial-up telephone modem.
The system has a cellular modem, but the signal strength is weak and does not improve when you move the system.
If you do not have wireless connectivity, follow the steps below.
1. Insert a USB flash drive into the USB port of the computer.
2. On the Merlin.net™ Patient Care Network Heart Failure Management Application, use the Export feature beneath the More
Actions link on the Patient Profile tab for your patient.
Refer to the Merlin.net Patient Care Network Heart Failure Management Application Help Manual for detailed instructions.
A USB flash drive is provided in the sensor box, but you can use any USB flash drive. Most commercial USB flash drives are
compatible with both the electronics unit and the computer you use to access the website.
Figure 19. The Other button
3. On the Patient Electronics System, select the Other button.
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Figure 20. The USB screen
4. Select the OK button on the Insert Website USB screen to load the data from the website.
If there are multiple patients found on the USB flash drive, screens for each patient on the USB flash drive appear.
Figure 21. The Verification screen
5. Verify that the patient information and the sensor information is correct.
When the system is successfully set up, the system displays the patient’s name above the Start button.
Patient Training
Discuss the information in the Patient System Guide with your patient before and after the implant procedure. For additional copies
of the patient’s guide, contact Technical Support. You should also explain the established benefits and risks of the CardioMEMS™
HF System with the patient. Discuss the home measurement schedule and the intended use of the system to manage their heart
failure symptoms.
Train the patient or their family member how to use the Patient Electronics System before the patient is discharged from the hospital.
Follow these steps:
1. Have the patient lie supine on the pillow.
The patient should position their torso so the center of the pillow is directly under the sensor. Typically, this means that the tip
of the shoulder blade nearest the sensor is centered on the pillow. Use the same antenna position that gave the optimal signal
during the implant procedure. Check the patient's records to confirm the actual location.
2. After the patient is in position, have the patient press either the Start button on the touchscreen or the round green button
below the touchscreen.
The system guides the patient with voice prompts and tones. The screen below appears while the system searches for a signal.
Figure 22. The Shift Position screen
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If the Shift Position screen appears, have the patient move positions to find the best position. Once a good signal is available,
the system says "Good Position on Pillow, Stay Still", and then begins to play music.
WARNING
Avoid placing the handheld unit directly on the pillow during a reading.
A reading takes approximately 18 seconds to complete. This allows the system to average multiple heart beats over several
breaths. When the reading is complete, the system attempts to send the reading.
Figure 23. The Connecting to Send Reading screen
If a wireless connection is available, the system sends the data and shuts down following the transmission.
If a wireless connection is unavailable or if the system uses a dial-up connection, select the Cancel button to stop the system
from attempting to connect.
Inform the patient that their system automatically sends the data and shuts down afterwards. If the system is unable to transfer
the readings to the website, they are stored for later transmission.
3. Select the Cancel button during the transmission if you do not want the system to shut down during training.
If the system has shut down, restart the system to take additional readings.
Pulmonary Artery Catheter Setup
The pulmonary artery catheter is used to set the baseline for a newly implanted sensor. If necessary, use the pulmonary artery
catheter during follow-up visits to reset the baseline if your patient has received any right-heart catheterizations since their last visit.
To take an accurate measurement, follow the guidelines below.
Ensure that the transducer is properly leveled and zeroed to atmospheric pressure.
If there are any concerns, repeat the setup.
Confirm that the pulmonary artery catheter PA pressure waveform is valid with minimal waveform distortion due to
measurement artifact.
Potential forms of measurement artifact include catheter whip, air bubbles in the pressure line, or catheter tip wedging. If
artifact is present, address the potential sources. Follow the standard procedures for fluid-filled catheter monitoring until the PA
pressure waveform appears to be reliable with minimal waveform artifact.
Confirm that the pulmonary artery catheter produces a steady mean pressure value.
Once the system is measuring the pressure, confirm that the height of the sensor pressure signal (systolic – diastolic) is within
+/- 25% of the height of the catheter pressure.
If it is not, confirm that any monitoring artifact has been sufficiently minimized. If the changes you make to minimize the
artifact result in a discrepancy between mean pressures, set the PA Pressure Baseline again. If artifact has been minimized and
pulse pressures are not within +/- 25%, repeat the sensor signal acquisition steps until pulse pressures match within +/- 25%.
Take a Follow-up Reading
This section explains how to take a follow-up reading with or without a wireless connection. If your Hospital Electronics System has
wireless connectivity, all of the patients on the website are available on the system. If it does not, you must manually load the
patient's information into the system.
Retrieve the Patient Information
With a Wireless Connection
To retrieve the patient information:
1. Select the Follow-Up button.
A list of patients available on the electronics unit appears on the screen.
2. Select the Check HF Website button to refresh the list from the website.
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You can search the list by entering information into the search box at the top of the screen.
3. Select the desired patient from the list.
4. Select the OK button.
Without a Wireless Connection
To retrieve the patient information:
1. Insert a USB flash drive into the USB port of the computer.
2. On the Merlin.net™ Patient Care Network Heart Failure Management Application, use the Export feature beneath the More
Actions link on the Patient Profile tab for your patient.
For information on the operation of the website, refer to the Merlin.net Patient Care Network Heart Failure Management
Application Help Manual.
3. Select the Follow-Up button on the screen.
A list of patients available on the electronics unit appears on the screen.
4. Select the Add button if the patient is not in the list.
5. Insert the USB flash drive when prompted.
6. Verify that the patient and sensor information is correct.
7. Select the OK button.
Acquire the Sensor Signal
To acquire the sensor signal:
1. Place the antenna under the patient’s back on the same side as the sensor.
2. Position the center of the antenna under the tip of the patient’s shoulder blade on the same side as the sensor.
The system asks you if pulmonary artery catheter pressure readings are available.
3. Select the Yes button or the No button.
This allows the system to capture these values for reference if they are available.
4. Check the signal strength.
If the signal strength bar is optimal (>70% and a green color), proceed to the Take a Reading section below. If not, refer to the
Optimize the Signal Strength section.
Take a Reading
The system allows you to take as many readings as needed. To take a reading:
1. Select the Take Reading button to capture pressure measurements.
If you previously indicated that pulmonary catheter reading values were available, the system prompts you to enter them.
2. Enter the pressure values and then select the OK button.
The captured reading is displayed for confirmation. The colored horizontal lines indicate the catheter pressure values entered
as reference (if available). The green line indicates the systolic pressure, the blue line indicates the mean pressure, and the red
line indicates the diastolic pressure.
3. If the reading is acceptable, select the Yes button to save the reading. If the reading is unacceptable, select the No button and
repeat the reading.
Transfer the Data
With a Wireless Connection
Once the readings are complete, the data is automatically transferred to the website. After the data is transferred, the system checks
for software updates. Refer to the Software Update section for more information.
1. Select the Exit button from the Data Acquisition screen.
2. If desired, select the Print button.
Without a Wireless Connection
Once the readings are complete, you must manually transfer the data to the website. To transfer the data:
1. Select the Exit button from the Data Acquisition screen.
2. Save the data to a USB flash drive.
3. If desired, select the Print button.
4. Insert the USB flash drive into the USB port of the computer.
5. On the website, select the Add Patient button and then the Import From Flash Drive button.
Locate the Sensor Signal
This section explains how to locate the sensor signal.
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Optimize the Signal Strength
Use fluoroscopy to improve the position of the antenna relative to the implanted sensor. If the signal strength is not optimal (<70% or
not green), follow the steps below.
1. Align the center of the antenna with the sensor and adjust the antenna to maximize the signal strength.
If the signal strength is optimal (>70%), return to the Acquire the Sensor Signal section and resume where you left off. If not, go
to step 2.
The system reads the sensor by sending out RF signals and detecting the return signal from the implant. RF signal reflections
can cause the system to detect signals at a frequency other than the true frequency. These technically suspect readings are not
pulsatile in nature, and the software helps you identify whether or not a signal is pulsatile. If the system detects that the signal is
pulsatile, the Signal Strength indication turns green. If the system determines that the signal is not pulsatile, the Signal Strength
indication turns blue. It is possible that the system could identify an actual signal with extremely low amplitude as non-pulsatile.
Use discretion when using the Signal Strength indicator.
2. From the Data Acquisitions screen, adjust the pressure Search scrollbar up or down in small increments.
Try to match the Search pressure value displayed next to the scrollbar with the mean pulmonary artery catheter pressure value.
If the signal strength is optimal, return to the Acquire the Sensor Signal section and resume where you left off. If the signal is
not acquired after you have moved the scrollbar position, return the scrollbar to the original starting position and go to step 3.
3. Shift the antenna position.
If the signal strength is optimal, return to the Acquire the Sensor Signal section and resume where you left off. If not, go to
step 4.
4. If the sensor orientation is fully lateral, lift the outer edge of the antenna into a partially tilted or lateral orientation from the side
of the rib cage to detect the sensor.
Technically Suspect Readings
Technically suspect readings originate from a source other than the sensor.
If you're in a room where the system is detecting a high signal strength (> 70%) from an unknown source:
Be aware that the maximum signal strength is achieved when the sensor and antenna are parallel. Rotate the patient or
antenna to attempt to eliminate the suspect reading.
Place the antenna between the operator and the patient.
Relocate to a different room.
Refer to the Interference section.
Figure 24. Technically suspect reading with high signal strength
The waveform in the figure above is non-pulsatile with no inflection for the heartbeat. The signal strength bar is blue.
If the signal strength indicator is 0, the system is most likely measuring a technically suspect reading and purposely forcing the signal
strength to 0. To resolve this:
Use the Search scrollbar to move off of this reading by repeatedly (and quickly) pressing the Search scrollbar button several
times.
Move the Search scrollbar in the direction of the patient's mean pressure measurement.
Refer to the Interference section.
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Figure 25. Technically suspect readings with low signal strength
The waveform in the figure above is pulsatile with a heartbeat but at a high pressure that does not make sense for the patient.
For all technically suspect readings, if the reported mean pressure reads above or below the value from the pulmonary artery
catheter:
Increase the value of the Search scrollbar if it’s too low.
Decrease the value of the Search scrollbar if it’s too high.
Patient Position
The signal strength is strongest when the antenna and sensor are parallel and close together. To decrease the distance between the
sensor and the antenna:
Ask the patient to place the antenna under the sensor.
Ask the patient to press the antenna firmly into their back.
Ask the patient to remove any metallic objects.
Have the patient shift into different positions.
Adjust the Search scrollbar until the mean pressure reads near the expected value.
Interference
To reduce interference:
Reduce the amount of metal in the vicinity of the sensor.
Reduce the number of electrical equipment and cables in the area.
Avoid the use of power strips and poorly grounded outlets when possible.
Move the C-arm away from the interrogation site.
Uncross guidewires.
Move or angle the antenna away from implanted devices.
Move ECG leads away from the antenna.
Troubleshooting the Patient Electronics System
Table 1. Troubleshooting
Problem
Symptom
Solution
Cannot get a signal Green bar never goes high
Voice continues to indicate low signal
Not able to complete a reading
successfully
Check for any noticeable damage to the unit.
Make sure there is no metal near the pillow.
Make sure there is no electric blanket near the pillow.
Reposition yourself on the pillow.
Contact your clinic.
Reading completes
but cannot send
data to your doctor
Error message says to check
connections
Error message says reading cannot be
sent
Check the USB cellular adapter, phone line or Wi-Fi adapter.
Make sure the phone line is working or you are getting adequate
signal strength on your wireless connection.
Make sure the phone line is not busy. Make sure your Wi-Fi network
name and password are correct.
Make sure the electronics unit is calling the correct number.
Contact your clinic.
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