St. Jude Medical CardioMEMS CM3000 Parts list manual

CardioMEMS™HF System
Model CM3000
System Guide

Do not attempt to use the device before reading and fully understanding the User’s Manual and the System Guide.
Carefully inspect all product packaging for damage or defects prior to use.
CAUTION: Federal
(USA) law restricts this device to sale by or on the order of a physician.
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Jude Medical or one of its subsidiaries. ST. JUDE
MEDICAL and
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Pat.
http://patents.sjm.com
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2017 St. Jude Medical, LLC. All Rights Reserved.

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Contents
Description .............................................................................................................................................................. 1
Indications............................................................................................................................................................... 1
Contraindications ..................................................................................................................................................... 1
Warnings ................................................................................................................................................................. 1
Precautions ............................................................................................................................................................. 2
Package Contents .................................................................................................................................................... 2
Sterilization .............................................................................................................................................................. 3
Components and Setup............................................................................................................................................ 3
Connect the System Cables ...................................................................................................................................................3
Printer..................................................................................................................................................................................3
The Pole Attachment.............................................................................................................................................................4
Hospital Electronics System Password Access ........................................................................................................................4
Patient and Hospital Electronics Systems.................................................................................................................. 5
Antenna................................................................................................................................................................... 5
Overview.................................................................................................................................................................. 6
Implant Procedure Overview ..................................................................................................................................................6
New Sensor Implant - Wireless Connection Available ................................................................................................ 6
Step 1: Enter Information.......................................................................................................................................................6
Step 2: Acquire Signal...........................................................................................................................................................8
Step 3: Set Baseline ..............................................................................................................................................................8
Step 4: Take Reading..........................................................................................................................................................10
Step 5: Transfer Data ..........................................................................................................................................................11
Step 6: Shutting Down the System .......................................................................................................................................11
New Sensor Implant – No Wireless Connection Available......................................................................................... 12
Step 1: Enter Information.....................................................................................................................................................12
Step 2: Acquire Signal.........................................................................................................................................................14
Step 3: Set Baseline ............................................................................................................................................................14
Step 4: Take Reading..........................................................................................................................................................16
Step 5: Transfer Data ..........................................................................................................................................................17
Step 6: Shutting Down the System .......................................................................................................................................17
Merlin.net Patient Care Network Heart Failure Management Application Setup........................................................ 18
Patient Electronics System Setup............................................................................................................................ 18
Setup – Wireless Connection Available .................................................................................................................................19
Setup - No Wireless Connection Available.............................................................................................................................20
Patient Training ..................................................................................................................................................... 22
Overview................................................................................................................................................................ 23
Follow-up Reading Overview................................................................................................................................................23
Follow-Up Reading – Wireless Connection Available................................................................................................ 23
Step 1: Retrieve Information ................................................................................................................................................23
Step 2: Acquire Signal.........................................................................................................................................................24
Step 3: Take Reading..........................................................................................................................................................24
Step 4: Transfer Data ..........................................................................................................................................................25
Step 5: Shutting Down the System .......................................................................................................................................25
Follow-Up Reading – No Wireless Connection Available .......................................................................................... 25
Step 1: Retrieve Patient Information [follow up no wireless] ...................................................................................................26
Step 2: Acquire Signal.........................................................................................................................................................27
Step 3: Take Reading..........................................................................................................................................................27
Step 4: Transfer Data ..........................................................................................................................................................28
Step 5: Shutting Down the System .......................................................................................................................................28
Locating Sensor Signal ........................................................................................................................................... 29
A. Optimize Signal Strength .................................................................................................................................................29
B. Technically Suspect Readings .........................................................................................................................................30
C. Distance.........................................................................................................................................................................30
D. Angulation......................................................................................................................................................................31
E. Solutions for Interference.................................................................................................................................................31
Troubleshooting the Patient Electronics System ...................................................................................................... 31
Pulmonary Artery Catheter Setup............................................................................................................................ 32
Manual Setup Instructions...................................................................................................................................... 32
New Sensor Implant............................................................................................................................................................32
Patient Electronics System Setup .........................................................................................................................................34
Follow-Up...........................................................................................................................................................................36

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Additional Hospital Electronics System Functions ................................................................................................... 38
A. Wireless Connectivity Setup............................................................................................................................................. 38
B. Setting Baseline in Follow-Up Reading............................................................................................................................. 38
C. Settings Screen............................................................................................................................................................... 39
D. The Admin Screen.......................................................................................................................................................... 39
Software Update ................................................................................................................................................................. 40
Additional Patient Electronics System Functions ..................................................................................................... 40
Patient Electronics System - Viewing Pressure Values During the Reading ............................................................................. 40
Guidelines for the Management of Hemodynamic Parameters ................................................................................ 41
Elevated PA Pressures (Hyper-volemic).................................................................................................................. 41
Low PA Pressures (Hypo-volemic).......................................................................................................................... 42
Recommended Frequency of CardioMEMS HF System Review............................................................................... 42
Clinical Study Information ...................................................................................................................................... 42
Introduction........................................................................................................................................................................ 42
Purpose ............................................................................................................................................................................. 43
Methods............................................................................................................................................................................. 43
Patient Demographics and Disposition ................................................................................................................................. 43
Primary and Secondary Endpoint Results............................................................................................................................. 44
Results from the Entire Randomized Access Period.............................................................................................................. 45
Cleaning................................................................................................................................................................ 61
Storage.................................................................................................................................................................. 62
User/Owner Responsibility ..................................................................................................................................... 62
Electromagnetic Interference and Electromagnetic Compatibility............................................................................. 62
FCC Statement ...................................................................................................................................................... 64
EU REACH SVHC Disclosure.................................................................................................................................. 64
WEEE Compliance Statement................................................................................................................................. 64
System Specifications ............................................................................................................................................ 64
Electrical Characteristics ..................................................................................................................................................... 64
Mechanical Characteristics.................................................................................................................................................. 65
Environmental Information .................................................................................................................................................. 65
Classification ...................................................................................................................................................................... 65
Testing............................................................................................................................................................................... 65
EMI/EMC Testing ................................................................................................................................................................ 65
Wireless Testing.................................................................................................................................................................. 65
Software ................................................................................................................................................................ 65
Technical Support ................................................................................................................................................. 66
Symbols ................................................................................................................................................................ 66

1
Description
The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart
failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.
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 Heart Failure Management Application Help Manual. For clinical study
information, please refer to the Clinical Study Information section.
Indications
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.
Warnings
Before use of the system, read this guide.
Only trained personnel should use this product.
Avoid excessive or damaging force when using the Hospital Electronics System (Model # CM3000).
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 electronics unit at a time in the same general
vicinity.
The CM3000 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 of the CM3000 as replacement parts for internal components, may result in increased emissions or
decreased immunity of the CM3000. 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.
The CM3000 should not be used adjacent to or stacked with other equipment. If it is necessary to operate adjacent or stacked
with other equipment, observe the CM3000 to verify normal operation in the configuration in which it will be used.
Other equipment may interfere with the CM3000 operation, even if the other equipment complies with CISPR emission
requirements. Refer to the EMI/EMC and Troubleshoot Procedure sections for guidance.
There are minimum amplitudes for the CM3000 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 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 from mains.
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.
Patients should be advised that if they develop redness of the skin or a change in skin sensitivity occurs, they should
discontinue use of this product immediately and contact their physician.

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All sensors have a unique calibration. Ensure 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.
This product is not made with natural rubber latex.
Precautions
Store the CM3000 in a temperature controlled, clean and dry area.
Use the CM3000 at temperatures between 5º to 40º C (41º to 104º F) and 15% to 93% humidity. Store the system between -25
to 70º C (-13º to 158º F), 15% to 93% humidity.
All electronic devices with the Hospital and Patient Electronics Systems, 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, please
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 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 CM3000 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. Mean pressure measurement
error has been 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 ESD levels, 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

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Sterilization
The Hospital Electronics System is provided non-sterile.
Components and Setup
Connect the System Cables
1. Align the keyed antenna at an approximately 30 degree angle and twist on the locking connector.
Figure 1. Connecting the antenna
2. Attach the connectors as shown in the figure below.
Connectors:
- Power supply connector (5 pin DIN)
- Printer serial communication cable (9 pin D-SUB )
- Printer power cable
Note: A VGA cable can be connected to the auxiliary VGA connector.
Figure 2. The connectors
1. Power switch
2. Power cable
3. Printer serial cable
4. VGA connection
5. Printer power cable
3. Plug the power cord into the power supply and plug the power cord into the wall.
Printer
The printer clips into the mount on the front of the electronics unit. The cables for the printer run under the electronics unit.
Disconnect them if necessary.

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Figure 3. The printer mount
The Pole Attachment
1. To mount the electronics unit to a pole, use the pole clamp.
2. Ensure that the pole is sturdy and can remain stable when at an incline of 10 degrees. Recommended pole: Pryor
Products, Inc. #135.
3. Ensure that the pole has locking wheels such that it can remain stationary on a 10 degree angle.
4. If the pole is on an incline, it may experience an initial settling movement prior to establishing a stable fix location, ensure that
control of the pole is maintained until stable.
5. If the pole has the ability to extend, do not extend the height of the pole. Keep the pole at its lowest height setting.
Figure 4. 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.

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Patient and Hospital Electronics Systems
The CardioMEMS PA Sensor is implanted into a distal branch of the descending PA. Following implantation, patients are instructed
to take pressure readings from home as directed by their physician. The information transmitted to the database is immediately
available to clinicians for review. The information consists of pressure trend information and individual PA pressure waveforms.
The Patient and Hospital Electronics Systems have been 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 in 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 sensor implant and when the patient needs measurements taken in a clinical setting.
The Hospital Electronics System should be mounted on a portable pole stand with wheels and stored in the Catheterization Lab area
or Heart Failure Clinic as needed by clinicians.
Figure 5. The Hospital Electronics System
1. Thermal printer
2. Touchscreen
3. USB ports
Antenna
The antenna attached to the Hospital Electronics System is designed for ease of use during implant and for follow-up measurements
in the hospital or clinic. The antenna is the means of coupling to the sensor and is connected to the electronics unit by a custom
cable with a locking connector. During a measurement, the antenna is placed near the sensor. 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 system for processing into a pressure waveform.
The arrows on the antenna control the Search pressure, and the green square lets you take a reading.
Due to the design of the system, you can leave the antenna attached to the electronics unit at all times if desired.
NOTE: The serial number on the antenna and on the electronics unit must match.
Figure 6. Antenna

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Overview
Implant Procedure Overview
For detailed instructions, refer to the following sections:
New Sensor Implant - Wireless Connection Available
New Sensor Implant - No Wireless Connection Available
New Sensor Implant - Wireless Connection Available
This section presents using the Hospital Electronics System to perform a sensor implant when a wireless connection is available for
communication with the Merlin.net Patient Care Network Heart Failure Management Application.
Before the Hospital Electronics can be used to measure a newly implanted sensor, the electronics must be set up with the following
information:
Patient Information
Sensor Characteristics
Step 1: Enter Information
All Hospital Electronics Systems are equipped with cellular antennas. WiFi is an available accessory. The workflow presented in this
section is recommended based on simplicity. These instructions expect that the conditions in your institution permit the use of
wireless connectivity. If this is not possible in your institution see the section New Sensor Implant – No Wireless Connection Available
below.
1. Patient Information: Prior to the first sensor implant of the day, use the Merlin.net Patient Care Network Heart Failure
Management Application to enter the patient information for all of the patients expected to receive a CardioMEMS HF sensor in
the cardiac catheterization lab that day. Please refer to the Merlin.net Patient Care Network Heart Failure Management
Application Help Manual for details.
Sensor Information: Each sensor has unique characteristics which must be loaded into the Hospital Electronics System. The
sensor information is stored on a USB flash drive inside the sensor box. It is important that the sensor information loaded into
the Hospital Electronics System matches the sensor implanted.
Wait until the time of sensor delivery and then follow the instructions below on the Hospital Electronics System for each new
sensor:
2. Insert USB flash drive from sensor package into the USB port.
3. Select New Implant button.
4. You will be presented with the list of patients that you entered into the Merlin.net Patient Care Network Heart Failure
Management Application.
5. Select the desired patient from the list.
6. If prompted, insert the USB flash drive from the sensor package into the USB port. (System will only prompt if USB flash drive
was not already inserted.)
7. After the sensor information is loaded, it will be displayed along with the patient information. Verify that Sensor Serial displayed
matches the Serial Number printed on the sensor box.
The screens for these steps are shown in the following sequence.

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Figure 7. Main screen, select New Implant.
Figure 8. Select patient from list downloaded from Merlin.net Patient Care Network Heart Failure Management Application.
NOTE: All screenshots are simulations and do not represent actual patients or actual patient data.
Figure 9. Insert USB drive if prompted. This screen will not appear if USB drive was already inserted.

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Figure 10. Verify patient and sensor information.
Step 2: Acquire Signal
Once you have loaded the patient and sensor information into the Hospital Electronics System and then implanted the sensor, the
steps below describe how to set the pulmonary artery (PA) pressure baseline.
1. Place the antenna under the patient’s back, approaching from the side where the sensor was placed. Antenna is not sterile.
Sliding the antenna between the sheet and the table works well. Position the center of the antenna under the tip of the patient’s
shoulder blade on the side of the torso where the sensor is located.
2. The signal strength (SS) bar indicates the robustness with which the Hospital Electronics System is measuring the implanted
sensor. If the signal strength bar is optimal (>70% and a green color, see figure below), go to the next step. If not, go to the
section Optimize Signal Strength.
Step 3: Set Baseline
1. A pulmonary artery or Swan-Ganz1catheter is used to set the baseline pressure for the sensor. For an accurate sensor
measurement, it is important to set up the pulmonary artery or Swan-Ganz catheter properly. See Pulmonary Artery Catheter
Setup section.
2. Initially, you will observe that the pressure values on the right of the waveform are dashed out. This indicates that the PA
pressure baseline has not been set.
Figure 11. Initial Pressure Waveform.
3. To Set the PA Pressure Baseline, wait for the screen to fill with a stable pressure waveform and then select the Set Pressure
Baseline button.
4. Enter the mean pressure from the pulmonary artery catheter measurement and select the OK button.
1Swanz-Ganz is a registered trademark of Edwards Lifesciences Corporation.

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Figure 12. Setting PA Pressure Baseline.
5. Wait for the screen to re-fill with a stable pressure waveform and then confirm that the sensor mean pressure matches the
catheter PA mean pressure within +/- 1mm Hg. Repeat the PA Baseline step as necessary to achieve a good match between
measurements.
Figure 13. System after PA Pressure Baseline has been set.
6. Confirm that the height of the sensor pressure signal (i.e., pulse pressure (systolic – diastolic)) is within +/- 25% of the catheter
pulse pressure. See Pulmonary Artery Catheter Setup section. Set the PA Pressure Baseline again, if necessary.
7. Setting the cardiac output baseline is an optional step.
8. To set the cardiac output (CO) baseline, you will need a reference value for cardiac output. This can be either thermodilution or
modified Fick.
9. Select the button Set CO Baseline. The Hospital Electronics System will indicate that the baseline data is being collected and
will prompt for the reference cardiac output once finished.

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Figure 14. Enter Reference Cardiac Output to Set Baseline.
10. Enter the reference cardiac output value and select OK.
Step 4: Take Reading
Once you are satisfied with the PA pressure baseline, take as many pressure readings as desired. Establishing accurate baseline PA
pressure at the time of implant is important to ensure accurate PA pressure readings from home.
1. Select the Take Reading button to capture pressure measurements.
2. The system will then prompt you to enter the comparative pulmonary artery catheter pressure values for reference. Enter the
catheter values and select the OK button. The comparative pulmonary artery catheter pressure values are optional. They are
used to visually check that the PA pressure values have the proper baseline and amplitude.
Figure 15. Enter Pulmonary Artery Catheter Pressure Values.
3. The captured reading is displayed graphically for confirmation. The colored horizontal lines indicate the catheter pressure
values entered as reference. The green line indicates systolic pressure, blue indicates mean pressure, and red indicates
diastolic pressure.

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Figure 16. Pulmonary Artery Catheter Pressure Reading
4. 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.
5. Re-confirm that the sensor mean pressure matches the catheter PA mean pressure within +/- 1mm Hg. Check the setup and if
necessary, set the PA Pressure Baseline again to achieve a good match between measurements.
6. Re-confirm that the height of the sensor pressure signal (i.e., pulse pressure (systolic – diastolic)) is within +/- 25% of the
catheter pulse pressure. Check the setup and if necessary, set the PA Pressure Baseline again to achieve a good match
between measurements.
Step 5: Transfer Data
Once the readings are complete, the Merlin.net Patient Care Network Heart Failure Management Application must be updated with
the information. In the case a wireless data connection is available, this happens automatically.After the data is transferred, the
system checks for software updates. Refer to the Software Update section for more information.
1. Select Exit from the data acquisition screen. If the user selects to print, the readings will print.
2. The baselines and readings will be automatically transmitted to the Merlin.net Patient Care Network Heart Failure Management
Application.
Step 6: Shutting Down the System
To shut down the system:
1. Navigate to the Main screen.
2. Select Shut Down on the Main screen.
Figure 17. Main screen, Select Shut Down
3. Allow the system to complete the shut-down sequence prior to disconnecting power from the system.
CAUTION: Disconnecting power before the shut-down sequence is completed may cause file corruption.

12
New Sensor Implant – No Wireless Connection Available
This section presents the use of the Hospital Electronics System to perform a sensor implant when a wireless connection is not
available for communication with the Merlin.net Patient Care Network Heart Failure Management Application. The patient
information is entered manually on the Hospital Electronics System.
Before the Hospital Electronics can be used to measure a newly implanted sensor, the electronics must be set up with the following
information:
Patient Information
Sensor Characteristics
Step 1: Enter Information
Each sensor has unique characteristics which must be loaded into the Hospital Electronics System. The sensor information is stored
on a USB flash drive inside the sensor box. It is important that the sensor information loaded into the Hospital Electronics System
matches the sensor implanted.
Wait until the time of sensor delivery and then follow the instructions below on the Hospital Electronics System for each new patient:
1. Insert USB flash drive from sensor package into the USB port.
2. Select New Implant.
3. Patient Information: Enter the patient information using the touch screen keyboard. To modify a field such as first name, simply
touch it and the touch keyboard will appear. It is necessary to fill out the first and last name fields and the birthdate. The phone
number field is optional. All of this information will appear on the website once implant is complete.
4. Sensor Information: Each sensor has unique characteristics which must be loaded into the Hospital Electronics System. The
sensor information is stored on a USB flash drive inside the sensor box. It is important that the sensor information loaded into
the Hospital Electronics System matches the sensor implanted.
5. If prompted, insert the USB flash drive from the sensor package into the USB port. (The system will only prompt if USB flash
drive was not already inserted.)
6. After the sensor information is loaded, it will be displayed along with the patient information. Verify that Sensor Serial displayed
matches the Serial Number printed on the sensor box.
The screens for these steps are shown in the following sequence.
Figure 18. Main screen, select New Implant.

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Figure 19. Enter patient demographic information.
Figure 20. Enter patient information using touch keyboard.
Figure 21. Insert USB drive if prompted. This screen will not be shown if the USB drive was already inserted.

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Figure 22. Verify patient and sensor information.
Step 2: Acquire Signal
Once you have loaded the patient and sensor information into the Hospital Electronics System and then implanted the sensor, the
steps below describe how to set the pulmonary artery (PA) pressure baseline.
1. Place the antenna under the patient’s back, approaching from the side where the sensor was placed. Position the center of the
antenna under the tip of the patient’s shoulder blade on the side of the torso where the sensor is located.
2. The signal strength (SS) bar indicates the robustness with which the Hospital Electronics System is measuring the implanted
sensor. If the signal strength bar is optimal (>70% and a green color), go to the next step. If not, go to the Optimize Signal
Strength section.
Step 3: Set Baseline
1. A pulmonary artery catheter is used to set the baseline for the sensor. For an accurate sensor measurement, it is important to
set up the catheter properly. See Pulmonary Artery Catheter Setup section.
2. Initially, you will observe that the pressure values on the right of the waveform are dashed out. This indicates that the PA
pressure baseline has not been set.
Figure 23. Initial Pressure Waveform.
3. To Set the PA Pressure Baseline, wait for the screen to fill with a stable pressure waveform and then select the Set Pressure
Baseline button.
4. Enter the mean pressure from the pulmonary artery catheter measurement and select the OK button.

15
Figure 24. Setting PA Pressure Baseline.
5. Wait for the screen to re-fill with a stable pressure waveform and then confirm that the sensor mean pressure matches the
catheter PA mean pressure within +/- 1mm Hg. Set the PA Pressure Baseline step again as necessary to achieve a good match
between measurements.
Figure 25. System after PA Pressure Baseline has been set.
6. Confirm that the height of the sensor pressure signal (i.e., pulse pressure (systolic – diastolic)) is within +/- 25% of the catheter
pulse pressure. See Pulmonary Artery Catheter Setup section. Set the PA Pressure Baseline again, if necessary.
7. Setting the cardiac output baseline is an optional step.
8. To set the cardiac output (CO) baseline, you will need a reference value for cardiac output. This can be either thermodilution or
modified Fick.
9. Select the button Set CO Baseline. The Hospital Electronics System will indicate that the baseline data is being collected and
will prompt for the reference cardiac output once finished.

16
Figure 26. Enter Reference Cardiac Output to Set Baseline.
10. Enter the reference cardiac output value and select OK.
Step 4: Take Reading
Once you are satisfied with the PA pressure baseline, take as many pressure measurements as desired. Establishing accurate
baseline PA pressure at the time of implant is important to ensure accurate PA pressure readings from home
1. Select the Take Reading button to capture pressure measurements.
2. The system will then prompt you to enter the comparative catheter pressure values for reference. Enter the catheter values and
select the OK button. The comparative pulmonary artery catheter pressure values are optional. They are used to visually check
that the PA pressure values have the proper baseline and amplitude.
Figure 27. Enter Pulmonary Artery Catheter Pressure Values.
3. The captured reading is displayed graphically for confirmation. The colored horizontal lines indicate the entered catheter
pressure values entered as reference. The green line indicates systolic pressure, blue indicates mean pressure, and red
indicates diastolic pressure.