Endotronix Cordella User manual

Cordella™Pulmonary Artery Sensor System
Instructions for Use
815 Ogden Avenue
Lisle, IL 60532
[email protected]om
Phone: [phone]
Endotronix Ireland Limited
DCU Alpha Innovation Center
Old Finglas Road
Glasnevin
Dublin 11, D11 KXN4
Ireland
Exclusively for Clinical Investigations.
To be used by Qualified Investigators Only.

(page left blank intentionally) Table of Contents
1. Introduction 5
1.1 Intended Use 5
1.2 Contraindications 5
2. Device Descriptions 8
2.1 Cordella™ PA Sensor 8
2.2 myCordella Patient Reader 8
2.3 Delivery System 9
2.4 Calibration Equipment 9
2.5 Cordella Data Analysis Platform (CDAP) 9
2.6 Recommended Accessories 10
3. Safety Information 11
3.1 Warnings: Implantation Procedure 11
3.2 Warnings: Reader and Docking Station 13
3.3 Precautions 15
3.4 Potential Adverse Events 17
3.5 MRI Safety Information 18
3.6 Sterilization 19
4. Instructions for Use 20
4.1 Pre-Procedure Preparation 20
4.2 Pairing and Interrogating the Cordella Sensor in Packaging 21
4.3 Delivery System Package Inspection 22
4.4 Vessel Mapping and Guidewire Placement 23
4.5 Delivery System & Cordella Sensor Insertion 26
4.6 Cordella Sensor Implantation 28
4.7 Calibrating the Sensor 31
5. Transport 33
6. Post-Procedure Antiplatelet Therapy 33
7. Patient Implant Card 33
8. Patient Reader Training 34
9. Reader/Docking Station Audio & Visual Cues 36

Instructions For Use | 5
10. Maintenance and Storage 38
10.1 Environmental Information 38
10.2 Replacement and Repair 38
12. Return Materials Authorization (RMA) 40
13. Inspection & Cleaning Instructions 40
14. Troubleshooting 41
14.1 Implant Procedure & Delivery System 41
14.2 Pairing and Interrogating the Cordella Sensor 42
14.3 Calibrating the Cordella Sensor 42
15. Useful Life 43
Appendices 45
Appendix A: Electromagnetic Compatibility 45
Appendix B: Equipment Specifications 50
Definition of Symbols 53
1. Introduction
The Cordella Pulmonary Artery (PA) Sensor System is intended to measure,
record, and transmit PA pressure data from NYHA Class III heart failure
patients at home to clinicians for assessment and patient-centered heart
failure management. It is designed to be used with the Cordella™ Heart
Failure System to better connect healthcare professionals and patients
with tools for comprehensive heart failure management. The Cordella
Heart Failure System consists of the patient-facing myCordella System
Pack and the clinic-facing myCordella Patient Management Portal (PMP).
The Cordella PA Sensor is an implantable blood pressure monitor
that permanently resides in the patient’s pulmonary artery. With this
innovative Cordella Sensor, PA pressure can be wirelessly measured from
the patient’s home on demand. Changes in PA pressure may indicate
fluid accumulation in the lungs. Active management of a patient using
the Cordella Sensor and the other peripherals of the myCordella System
Pack may improve long-term outcomes in patients with New York Heart
Association (NYHA) Class III heart failure.
1.1 Intended Use
The Cordella PA Sensor System is intended to measure, record, and
transmit pulmonary artery pressure data from NYHA Class III heart failure
patients at home to clinicians for assessment and patient-centered heart
failure management.
1.2 Contraindications
The Cordella PA Sensor System is contraindicated for patients that cannot
tolerate anticoagulation or antiplatelet regimens. The Cordella Sensor is
not recommended for patients with venous peripheral stents, inferior vena
cava filters, or artificial valves in the path of the Delivery System.

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1.3 Component Names
Cordella™ Pulmonary Artery Sensor System
This system is exclusively for clinical investigations.
An innovative myCordella Peripheral designed for on-demand
measurement of pulmonary artery pressure from the patient’s home.
The system includes:
• A catheter-based Delivery System with a pre-loaded Cordella Sensor for
implant in the pulmonary artery
• Calibration Equipment (CalEQ) for collecting relevant calibration
information during implantation
• myCordella Patient Reader for patient use to measure PA pressure in the
home, which communicates wirelessly to the myCordella Hub
• Cordella Data Analysis Platform (CDAP) for cloud-based storage and
analysis of home PA pressure readings (not pictured)
Cordella™ Heart Failure System
This system is commericially available.
myCordella™ Patient Management
Portal (PMP)
A web-based application that
displays patient data received
from the myCordella Hub to the
clinician. The PMP is intended to
assist clinicians in efficiently and
effectively managing patients and
driving treatment changes when
necessary.
myCordella™ Hub (Display Screen)
An intuitive, user-friendly display
screen that assists patients with
obtaining vital sign measurements.
• Collects & securely transmits daily
health information to clinicians
• Provides secure communication
between patient and clinician
• Facilitates review of past
measurements
• Facilitates review of patient goals
myCordella™ System Pack
• myCordella Hub
• A&D Deluxe Connected Weight
Scale
• A&D Deluxe Connected Blood
Pressure Monitor
• Nonin Pulse Oximeter
• myCordella Hub Stand
• myCordella Carrying Case
• Stylus and Tether
• myCordella Patient Manual
• myCordella Quick Start Guide

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2. Device Descriptions
The Cordella Pulmonary Artery Sensor System measures pulmonary artery
(PA) pressure on demand to help clinicians identify pulmonary congestion
suggestive of worsening heart failure through evaluation of trends of
pulmonary artery pressure values. The Cordella PA Sensor System consists
of a catheter-based Delivery System with a pre-loaded Cordella PA Sensor
(Cordella Sensor), Calibration Equipment (CalEQ), a Reader that allows
patients to measure PA pressure at home, and Cordella Data Analysis
Platform (CDAP), a cloud-based platform to store and analyse the PA
pressure measurements.
2.1 Cordella™ PA Sensor
The Cordella Sensor is a small implant that resides permanently in
the patient’s pulmonary artery. The Cordella Sensor does not contain
batteries or active electrical components.
2.2 myCordella Patient Reader
The myCordella Patient Reader (Reader) is
a handheld device that is provided to the
patient for at-home use to measure PA
pressure on demand. The Reader wirelessly
transmits the raw data obtained from the
Cordella Sensor to the myCordella Hub.
The raw data is converted into readable
data and sent to the myCordella Patient
Management Portal for the clinician to
review.
2.3 Delivery System
The Delivery System is a catheter with a pre-loaded Cordella Sensor at the
distal end and is used to implant the Cordella Sensor into the pulmonary
artery. The Delivery System is comprised of a stability sheath, torque
catheter, torque catheter handle, torque luer, and side port. Implantation
of the Cordella Sensor using the Delivery System is designed to be
performed during right heart catheterization through venous access.
The Cordella Sensor and Delivery System are packaged together and
sterilized with ethylene oxide before shipment. The Delivery System is
designed for single use and should not be reused or re-sterilized. If the
sterile package has been compromised, do not use the Cordella Sensor
and Delivery System, and contact Customer Support.
2.4 Calibration Equipment
The Calibration Equipment (CalEQ) is
hospital equipment that supports the
implantation procedure.
• Facilitates linking of component serial
numbers to patient IDs.
• Calibrates the Cordella Sensor to a reference
pressure at the time of implantation.
• Interrogates the Cordella Sensor to verify
proper working condition.
• Trains patient on optimal Reader placement
post-procedure.
2.5 Cordella Data Analysis Platform (CDAP)
The Cordella Data Analysis Platform (CDAP) is a secure, cloud-based,
standalone application that collects and stores raw Reader data and
processes it according to pre-defined algorithms to convert it into final-
form pulmonary artery pressure data.

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2.6 Recommended Accessories
Cordella Pulmonary Artery Sensor System is recommended for use with
the accessories listed in the following table. These accessories are not
included in the Cordella Sensor and Delivery System packaging.
Item Specifications
Vascular Access Kit 14 Fr Introducer Sheath (see
recommendation) and dilators
with preferred access guidewire (no
Endotronix recommendation)
14F Introducer Sheath Cook performer introducer, Item No.
G08024 RCF 14.0-38J-14F - 13cm length
PA Catheter Swan-Ganz thermodilution pulmonary
artery catheter
Procedural Guidewire Stiff Amplatz Guidewire (260cm;
straight-tip; 0.025” or 0.018”)
Pigtail catheter 6F pigtail catheter (ID>0.06”)
Additionally, Endotronix recommends use of the following catheter lab
equipment and supplies during Cordella Sensor implantation. They are the
same items typically used during right heart catheterization procedures.
• Fluoroscope with digital angiography capabilities and ability to
record and recall images
• Fluid-filled or electrical blood pressure monitoring equipment
to obtain a PA pressure measurement during a right heart
catheterization procedure
• Hand injector and radiopaque contrast media for visualization. DO
NOT use an automated injector through the Stability Sheath.
• Patient Monitor
3. Safety Information
Before use of the Cordella Pulmonary Artery Sensor System,
thoroughly read and understand the instructions for use to avoid
potential injury or death.
Warnings
Warnings indicate the
possibility of system damage
or malfunction, delay in receipt
of information to a healthcare
provider, inaccurate readings,
or injury.
Precautions Precautions indicate the
possibility of system damage,
malfunction, or the delay in
treatment.
3.1 Warnings: Implantation Procedure
• Only trained personnel should use the Cordella Pulmonary Artery Sensor
System.
• The implant procedure must be performed by trained clinical personnel
with the appropriate interventional and surgical skills, including but
not limited to implantable device placement and deployment over a
guidewire and in a location with the infrastructure to support right heart
catheterizations.
• DO NOT reuse, reprocess, or re-sterilize the Cordella Sensor and Delivery
System. The Cordella Sensor and Delivery System are for single use only.
Any reuse, reprocessing, or re-sterilization may influence the structural
integrity of the components of the device and could lead to transmission
of infectious diseases, other types of infections from one patient to
another, as well as many other serious adverse events including but not
limited to injury, illness, or death of the patient.

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• Use only the cables and accessories provided. The use of accessories,
transducers, or cables other than those specified, with the exception
of transducers and cables provided as replacement parts, may result
in increased emissions, decreased immunity of the system, inaccurate
readings, damage to the system, injury to user, or improper operation.
• Fluoroscopy is required to perform the implant procedure in order to
visualize the target vasculature and to ensure proper device placement.
• Cordella Sensor should be placed into the patient’s right pulmonary
artery with diameter ≥12 mm and ≤30 mm at the right pulmonary artery
downturn.
• As much as possible, avoid contacting the Cordella Sensor with any
subsequent catheters or wires. When contact is unavoidable (e.g. during
Delivery System withdrawal), take care to avoid disrupting the Cordella
Sensor.
• Avoid vessel wall contact with the Delivery System whenever possible.
Too much or too forceful contact may perforate the vessel.
• DO NOT advance or retract the Delivery System without a guidewire in
place.
• Following device implantation, all future right heart catheterizations
(RHCs) will require fluoroscopy to reduce the likelihood of catheter or
guidewire contact with the Cordella Sensor.
• DO NOT pull the release wires prior to intended deployment. Any
strain on the release wires may loosen the Cordella Sensor tie down
mechanism.
• DO NOT mishandle the Delivery System or use it if the packaging or
any components are not sterile, have been opened or are damaged (i.e.
kinked or stretched), or the expiration date has elapsed. Do not attempt
to repair a damaged Delivery System. Replace it with another Delivery
System from inventory and return the device to Endotronix through the
RMA process.
• After Cordella Sensor deployment, take care to remove the Delivery
System slowly and gently to avoid moving the Cordella Sensor.
• DO NOT attempt to modify, disassemble, or otherwise alter the Cordella
Pulmonary Artery Sensor System.
• During the implant procedure, there should be a continuous heparin drip
to prevent clotting.
• DO NOT expose the Cordella Sensor to therapeutic levels of ultrasonic
energy.
• To avoid risk of electric shock, CalEQ must only be connected to a supply
main with protective earth.
• DO NOT plug additional devices into the CalEQ power strip.
• DO NOT use more than one CalEQ in the same general vicinity at one
time, as use of multiple CalEQs at once may cause them to interfere with
each other.
• After the implatation procedure, it is critical for the patient to adhere to
prescribed anticoagulation and other medications from the physician.
3.2 Warnings: Reader and Docking Station
• The Reader is suitable for home healthcare environments and
professional healthcare facilities except for near active heart failure
hospital equipment and the radiofrequency (RF) shielded room of a
medical electrical (ME) system for magnetic resonance imaging, where
the intensity of electromagnetic (EM) disturbance is high.
• The Reader and Docking Station should not be used adjacent to
or stacked with other equipment. If it is necessary to operate the
components adjacent to or stacked with other equipment, verify that the
system is operating normally in the configuration in which it will be used.
• DO NOT expose any power accessories, the Reader, or the Docking
Station to food or liquids.
• DO NOT use myCordella in the presence of explosive or flammable
anaesthetic agents.
• The Cordella PA Sensor System is not intended for emergency use or real-
time monitoring.
• Power cables may pose a tripping hazard. Be mindful of cords crossing
walkways.
Warnings: Implantation Procedure (Cont.)

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• myCordella Patient Reader may be interfered with by other equipment
generating electromagnetic fields. When possible, avoid using the Reader
while simultaneously using other equipment within ~1.5 meters such as:
patient monitoring systems, chest EKG leads, motors on motorized beds,
pagers, laptop computers, tablets, cell phones, cordless phones, wireless
routers, air conditioners, or walkie talkies (450MHz devices) within ~3
meters.
• The Reader requires special precautions regarding electromagnetic
compatibility (EMC) and needs to be placed into service according to
the EMC information provided. If interference is noted (e.g. if CalEQ and
Reader continue to disconnect), remove or stop using the interfering
equipment.
• Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than
~1.5 meters to any part of the Reader. Otherwise, degradation of the
performance of the Reader could result.
• The patient should not have necklaces, jewellery, shirt pocket contents,
metal objects, and near field communication objects in the vicinity of the
reading location while taking a reading.
• Under certain conditions, the Reader’s surface may exceed 41°C. If the
Reader becomes too warm to hold comfortably, place it back in the
Docking Station and wait for several hours for it to cool. If the Reader
remains too warm to hold comfortably for more than a day, contact
Customer Support.
• If the skin becomes red, warm, or irritated, immediately stop using the
Reader and contact Customer Support.
• DO NOT use more than one Reader in the same general vicinity at one
time, as use of multiple Readers at once may cause them to interfere
with each other.
3.3 Precautions
• The Delivery System should only be used with a guidewire. Do not
aspirate or infuse the Delivery System guidewire lumen during use.
• The implant procedure is an adjunct to a standard (RHC) procedure. All
standard protocols for the RHC should be followed.
• The Cordella Sensor is attached to the distal end of the Delivery System;
care should be taken to limit contact with the Sensor prior to insertion
through the introducer sheath.
• Ensure all Luer connections are secure (but not over-tightened) prior to
insertion through the introducer. If at any time during the procedure the
Stability Sheath comes loose from the Torque Catheter, reconnect and
tighten the Luer connection to secure until after Sensor deployment.
• Removing the Cordella Sensor after implantation is not recommended.
• If there is evidence of a change in device performance, please contact
Customer Support.
• The Cordella Sensor and Delivery System are only compatible with a 14
French introducer or larger. Use of a smaller introducer may damage
the Cordella Sensor or Delivery System product and may prevent
introduction. Endotronix does not recommend use of peel away
introducers.
• Precaution should be taken to avoid disruption of the Cordella Sensor
position after deployment with the Delivery System or any subsequent
devices used during right heart catheterization procedures.
• Torqueing the Stability Sheath with the Torque Catheter removed may
result in kinking of the Stability Sheath and may impact the reliability of
a fluid-filled pressure measurement.
• Precaution should be taken to avoid damage to the Cordella Sensor prior
to implantation. It is an all-glass enclosure and it is fragile. Only remove
from packaging when ready to start a procedure. Take care to avoid
shock or drop to the distal end of the Delivery System where the Cordella
Sensor is pre-mounted. Care should be taken to limit contact with the
Cordella Sensor prior to insertion through the introducer sheath.
• Avoid squeezing or pinching the body of the Cordella Sensor if at all
possible.
Warnings: Reader and Docking Station (Cont.)

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• DO NOT place more than one Cordella Sensor in a patient. The two
Cordella Sensors may interfere with each other and limit the ability to
obtain accurate readings.
• The mean pressure measurement accuracy of the system may be
affected by various factors. Signs of mean pressure measurement error
include: gradual mean pressure changes without a corresponding
proportional change in pulse pressure (systolic-diastolic pressure),
negative mean pressures, acute shift in mean pressures, and non-
physiologic acute shift in mean pressures persistent over multiple
measurements. If any of these signs are observed, temporarily suspend
use of the pressure information for management of the patient and
contact Customer Support for further assistance. Baseline (mean
pressure) recalibration may be necessary to continue use of the system.
• Activities that may expose the patient to pressure extremes may affect
device performance. If the patient plans to SCUBA dive, please contact
Customer Support.
• Accuracy of the Cordella Pulmonary Artery Sensor System is slightly
affected by large changes in elevation between the initial baseline
calibration and subsequent measurements. Readings may lose accuracy
when taken at >2000m of elevation.
• The CalEQ should not be used in the sterile field.
• DO NOT expose any components of myCordella to water or liquids.
Contact Customer Support for a replacement if any components are
exposed to liquids.
• DO NOT drop the Reader. Handle with care.
• If dropped, the Reader may expose the battery. If the battery is exposed,
contact Endotronix immediately for a replacement Reader. Any damage
to the Reader may result in an inaccurate reading.
• DO NOT use the Reader if the plastic casing has been damaged, cracked
or any component becomes dislodged.
• If the Reader label becomes comprimised, contact Endotronix Customer
Support
• Accuracy of the Cordella Pulmonary Artery Sensor System is affected by a
change in body temperature (<-3mmHg/∆°C).
3.4 Potential Adverse Events
Potential risks associated with the overall procedure include potential access
complications associated with standard right heart catheterization, the
potential risks of conscious sedation, and the use of angiography:
• Allergic reaction
• Arrhythmias
• Bleeding complications (which may require transfusion)
• Cardiac arrest
• Chest pain
• Death
• Device embolization/migration
• Emergent or urgent cardiac surgery necessitated by the device or
procedure
• Endocarditis or device infection
• Entry site complications (e.g., hematoma, dissection)
• Gastrointestinal bleed
• Haemoptysis
• Hypo or hypertension
• Infection or fever
• Peripheral embolism/thrombus
• Pulmonary embolism/pulmonary occlusion
• Pseudoaneurysm of the vein
• Radiation exposure
• Reaction to contrast media/medication
• Renal insufficiency or failure
• Respiratory distress or failure (breathing problems)
• Sepsis
• Valvular injury (tricuspid and/or pulmonary)
• Vascular complications (e.g., venous dissection, perforation, rupture,
arteriovenous fistula,)
• Vessel trauma which may require surgical repair
• Worsening heart failure
Precautions (Cont.)

Instructions For Use | 1918 | © 2018 Endotronix Inc. 100474-00 Rev 1
3.5 MRI Safety Information
Non-clinical testing and MRI simulations were performed to evaluate
the Cordella Sensor. Non-clinical testing demonstrated that the Cordella
Sensor is MR Conditional. A patient with this implant can be scanned
safely in an MR system under the following conditions:
MR Conditional
• Static magnetic field of 1.5 Tesla or 3 Tesla only
• Maximum spatial gradient magnetic field of 10,000 gauss/cm
(100 T/m)
• Maximum MR system reported, whole body averaged specific
absorption rate (SAR) of 2 W/kg for 15 minutes of scanning (i.e.,
per pulse sequence) in the Normal Operating Mode
Under the scan conditions defined, the Cordella Sensor is expected
to produce a maximum temperature rise of 4.5°C after 15 minutes of
continuous scanning (i.e. per pulse sequence). If defined MRI conditions
are not followed, there is increased risk of additional heating or movement
of the Cordella Sensor or of damage to the Cordella Sensor.
Selecting the optimal MR imaging parameters may be necessary if the
goal is to image close to the Cordella Sensor. In non-clinical testing, the
image artefact caused by the Cordella Sensor extends approximately 6
mm from this device when imaged with a gradient echo pulse sequence
and a 3 Tesla MR system.
NOTE: It is important that the patient understands they should inform
clinical staff who will be performing an MRI scan that the patient has
an implanted Cordella Sensor and to refer to these guidelines. The MR
Conditional symbol is on the patient’s implant card, which should be given
to the patient after the implant and be carried with them at all times.
The Cordella Sensor is safe to use with ultrasound imaging, but DO NOT
expose to therapeutic levels of ultrasonic energy.
Contact Endotronix Customer Support (see Contact Us section) for current
MR Conditional labelling and the most up-to-date instructions for this
device in the MR environment.
3.6 Sterilization
The Delivery System package contents have been sterilized with ethylene
oxide before shipment. The system is for single use and is not intended
to be re-sterilized. If the sterile package has been compromised, replace
it with another Delivery System from inventory and contact Customer
Support.

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4. Instructions for Use
Implanting physicians are required to have completed the Cordella
Pulmonary Artery Sensor System training, which includes didactic and
clinical education material.
4.1 Pre-Procedure Preparation
1. Within the myCordella Patient Management Portal on a separate
computer, download and print the patient’s QR Barcode Report
through the Download Wizard in the patient’s chart (for detailed
instructions, see the myCordella Patient Management Portal Clinician
Manual: PA Pressure).
2. At least 30 minutes before the procedure, transport the CalEQ and
Delivery System box, including a backup Delivery System, to the
catheterization lab (see Transport section). Ensure the CalEQ includes
two Readers and Docking Stations.
3. Plug in the CalEQ power strip to an easily accessible outlet. Ensure
the Readers are in the Docking Stations and the Docking Stations are
plugged into the power strip. Always keep Readers docked when not
in use. The light on the Docking Station will blink while charging and
change to solid when the Reader is fully charged. To turn a Reader on,
press and hold the small button at the base of the Reader for several
seconds.
4. Turn on the CalEQ by pressing the power button on the bottom of the
monitor and sign in as the CalEQ user.
4.2 Pairing and Interrogating the Cordella Sensor
in Packaging
1. Press ‘Calibrate.’ Scan the barcode on
the Delivery System unit box.
2. On the confirmation screen, ensure
there is a green checkmark on the screen.
Press the “Next” button if the information
matches.
3. Undock the Reader when prompted.
While searching for the Sensor, the
Reader will display a solid blue light and
will beep twice every few seconds. Wait
until the CalEQ advances to the searching
screen, holding the Reader away from the
Delivery System packaging.
4. Position the Reader along the top of
the Delivery System box near the location
symbol shown here. Until a signal is
found, reposition the Reader over the top
and side of the box.
5. The CalEQ will search for a signal from
the Sensor. If a signal cannot be found,
DO NOT use the Delivery System. Repeat
the procedure with a new Delivery
System package and contact Customer
Support after the procedure.
6. When prompted to pair to the
patient, remove the scanner and scan the
QR Barcode Report that was printed from
the PMP. If the patient ID does not match,
the PMP barcode report will need to be
reprinted and rescanned.

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7. On the confirmation screen,
ensure all Cordella Sensor and patient
information is correct.
DO NOT scan visibly damaged barcodes; use a different Delivery
System package.
4.3 Delivery System Package Inspection
1. Inspect the Delivery System package carefully for any damage before
opening.
2. Ensure the “Use By” Date on the product label has not passed. The
implant of the Cordella Sensor is not permitted after its expiration
date.
3. The primary box contains one Cordella Sensor tied down to the distal
end of the Delivery System and the product documentation.
4.4 Vessel Mapping and Guidewire Placement
The Cordella Sensor is implanted in the patient’s right pulmonary artery.
The following image is provided for reference with useful anatomical
landmarks indicated:
Apical Branch
Downturn
Right PA
Main Bifurcation
Left PA
1. Set up the patient for venous access. Position the sterile drape to allow
for non-sterile access to the patient’s chest. Position ECG leads as far
away from the right side of the patient’s chest and side as possible.
Endotronix recommends limb ECG leads.
2. Gain access to the patient’s vein and expand to allow for a 14 French
introducer. Begin a typical right heart catheterization by floating a
pulmonary artery catheter (PAC) or steering a guide catheter to the
right pulmonary artery.
3. Introduce a 0.018” or 0.025” diameter guidewire through the lumen
of the catheter and place the distal tip of the guidewire distal to the
target implant location.

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4. Exchange the catheter for a pigtail catheter and remove the guidewire.
Ensure the pigtail catheter extends into the right PA as shown.
5. Inject contrast agent through the pigtail catheter to illuminate the
right pulmonary artery and provide a roadmap for identifying proper
Sensor deployment location. Using the markers on the pigtail (10mm
spacing) estimate the diameter of the right PA main vessel at the
downturn. The vessel at this location must be between 12-30mm. If
the vessel appears to be either larger or smaller than the indicated
range, abort the procedure and DO NOT implant the Cordella Sensor.
12-30mm dia.
6. Introduce a guidewire (.018”-.025”, 260cm-300cm) through the
lumen of the pigtail catheter extending into the right pulmonary
artery. Ensure that the wire follows the main branch of the right
pulmonary artery and remains in the main branch for appx. 6cm
beyond the downturn.
7. Remove the pigtail catheter, leaving the guidewire in place.
WARNING: Ensure that the guidewire is in the main
right pulmonary artery distal to the implant location
and NOT in a side branch.

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4.5 Delivery System & Cordella Sensor Insertion
1. Catheterization lab staff should assist the implanter in sterile removal
of the Cordella Sensor and Delivery System from the sterile packaging
and record the Sensor Serial Number in the patient’s chart with the
peel and stick label.
2. Inspect the entire effective length of the Delivery System carefully for
any damage, including kinks, burrs, roughness, or tight connections.
The features of the Delivery System handle are labeled below:
Side Port/
Contrast Injection Site
Release Wire Cap
Handle/Torque Control
Torque Luer
Stability Sheath
surrounding
Torque Catheter
3. Ensure the Cordella Sensor is tied down correctly by comparing to the
image below.
4. If the Delivery System or Cordella Sensor appears damaged or
defective, do not use the product and contact Customer Support.
WARNING: The Cordella Sensor should not be
interrogated by the Reader after removal from the
packaging until the Sensor is implanted.
5. Remove the stylet from the distal end of the Delivery System and
flush the side port and guidewire lumen with sterile saline using a
hand syringe.
6. Thread the Delivery System over the guidewire through the distal tip
(front-end loading).
7. Grip the catheter directly behind the Cordella Sensor as shown and
gently push the Cordella Sensor through the introducer. Care should
be taken to push from the back of the Cordella Sensor to minimize
damage and changes to the tiedown configuration.
WARNING: If touching the Cordella Sensor is necessary,
grab only by the sides and not the top surface as this
may cause Sensor damage.
8. Slowly push the Cordella Sensor through the introducer. If severe
resistance is encountered, stop pushing the Cordella Sensor and
attempt to identify the source of resistance. Proceed cautiously.

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4.6 Cordella Sensor Implantation
1. The target location for the Cordella Sensor is at the downturn of the
right PA (highlighted in the figure below for a representative typical
PA anatomy). The location can be defined by the overlapping region
of the main right PA trunk and the downturn as illustrated below.
The distal radiopaque marker bands on the Sensor should be within
the highlighted area upon Sensor deployment. Anterior-Posterior
imaging is recommended for proper anatomical visualization.
2. Advance the Cordella Sensor to the target area using the Torque
Handle to navigate through the heart to the right pulmonary artery.
3. Once in the optimal position, the Cordella Sensor has three (3)
radiopaque marker bands to help identify rotational position of
the Sensor. Rotate the Cordella Sensor using the Torque Handle as
necessary to ensure the Sensor is anterior facing as shown below:
4. Once in target deployment position (Sensor body at RPA downturn,
anterior facing), deploy the Cordella Sensor by detaching and pulling
the release wire cap, then fully removing the release wires. Release
wire cap and wires may be discarded.
5. Once the Cordella Sensor is deployed, unscrew the torque luer to
disconnect. Hold the handle in a stable position within the palm of
the hand.

Instructions For Use | 3130 | © 2018 Endotronix Inc. 100474-00 Rev 1
6. While visualizing under fluoroscopy, gently and slowly withdraw the
Torque Catheter past the Cordella Sensor, making sure not to disturb
the Cordella Sensor location. Leave the Stability Sheath in place near
the newly deployed Cordella Sensor. Once the Torque Catheter is fully
removed, separate the guidewire and discard the Torque Catheter.
WARNING: If the Torque Catheter engages the
Cordella Sensor, stop withdrawing the Torque
Catheter, rotate approximately 90 degrees and
resume slow, gentle retraction until clear of the
Cordella Sensor.
7. Use the Stability Sheath as a fluid-filled column to obtain a reference
pressure by attaching the side port to the pressure transducer, making
sure to:
• Adjust the pressure transducer height to half of patient’s chest
height
• Flush the catheter and fluid line to ensure there are no air bubbles
• Zero the measurement
• Check that the catheter tip is positioned within the PA and that
the catheter does not cross the Sensor.
8. Screw the tethered blue luer cap onto the Stability Sheath hub to
prevent back-bleeding through the hemostasis valve.
WARNING: Avoid torquing the Stability Sheath when
used as a fluid-filled column. Torquing can result
in kinks which inhibit accurate reference pressure
measurements for Sensor calibration.
4.7 Calibrating the Sensor
NOTE: During Reader operation, electromagnetic interference (EMI)
generating equipment may need to be temporarily moved away from the
Reader’s zone of operation. This may include temporarily repositioning
any ECG leads, pagers, or patient monitoring systems away from the
Reader.
WARNING: DO NOT USE 450MHz devices, such as
Walkie Talkies or intercom systems, near the Reader.
1. The CalEQ system will prompt
the user to zero the reference
pressure.
2. Enter the systolic and diastolic
values from the fluid-filled pressure
measurements on the patient
monitor. Press the “Next” button.
3. Undock the Reader when
prompted. CalEQ will proceed to
the Calibrate Sensor screen, where
it will show a live, uncalibrated
waveform. Adjust the position of
the Reader over the patient’s chest
until the signal percentage is as
high as possible (>75%). Once signal
percentage above 75% is achieved,
hold the Reader still for 20 seconds
and monitor the waveform in
preparation for calibration.

Instructions For Use | 3332 | © 2018 Endotronix Inc. 100474-00 Rev 1
4. Imediately after, CalEQ will calibrate the Cordella Sensor for 18 seconds. Do not
adjust the Reader position during this time. A progress bar above the waveform
displays the progress through calibration, and the live waveform will be paused.
5. When prompted, dock the Reader.
6. A report containing Cordella Sensor pressures, reference pressures, a comparison
between them, and the corrected waveform will appear. If the results are
acceptable, press the “Accept” button. If a recalibration seems necessary for any
reason, press the “Calibrate Again” button and repeat the calibration steps.
7. After the procedure, save the
calibration data. If the CalEQ is
connected to the network, select
the “Upload to Cloud” button
and wait for verification that the
upload was successful. If the
CalEQ cannot upload the data,
press “Upload Later” and notify
Customer Support.
8. Remove the Stability Sheath and introducer sheath. Close the venous access
site per standard protocols.
5. Transport
To transport the CalEQ, turn off
the computer. To do this, press the
“Menu” button (three horizontal
lines), select “End Session”, then
select “Power Off”.
Unplug the power strip and wrap
up the power cord. The CalEQ
computer, Docking Station, and
backup Docking Station should
remained plugged into the power strip. The Reader and backup Reader
should remain in the Docking Stations during transport. Lower the CalEQ
screen as far as possible by depressing the foot pedal.
The Reader should be powered off before transport. To transport the
Reader, press and hold the small button located on the bottom of the
Reader, at the base of the handle and adjacent to the power connector,
for several seconds. Depressing the button will disable the audio and
visual cues on the Reader and prevent damage to the batteries. This same
process can be used to Power Off the Reader at any time. To restart the
Reader after transport, press and hold the button again. If the button is
depressed but the Reader doesn’t respond, the battery is likely discharged;
return the Reader to the Docking Station and allow the Reader to charge.
6. Post-Procedure Antiplatelet
Therapy
It is recommended to use dual antiplatelet therapy as per the site’s standard
of care anticoagulation protocol for 30 days post-implant. Endotronix
recommends aspirin and clopidogrel, though prasugrel or ticagrelor can
be used in replacement of clopidogrel. After 30 days, single antiplatelet
therapy with aspirin is recommended indefinitely or until other directives
are provided by the cardiologist.
7. Patient Implant Card
A patient identification card is provided and should be given to the patient
after implantation. Advise patients to keep this card in their possession at
all times.

Instructions For Use | 3534 | © 2018 Endotronix Inc. 100474-00 Rev 1
8. Patient Reader Training
Post-implant, patients should complete training on CalEQ to learn the
best placement of the Reader.
1. From the CalEQ home screen, the user can press the “Training” button.
2. CalEQ will display an animation that walks through the steps of taking
a reading.
3. After the training video, the trainer or patient can press the
“Start Training” button, undock the Reader when prompted, and
automatically move into the Training screens.
4. As the patient moves the Reader around on their chest and side, they
will receive feedback on the signal strength from CalEQ. As signal
strength changes, the pointer on the dial will move clockwise or
counter clockwise and the signal symbol below will grow and shrink
between one and three signal bars. After several seconds of strong
signal, as indicated by the dial pointer remaining in the green section
on the right side of the dial, training will end and the patient will be
prompted to dock the Reader. There is no limit to the number of
times a patient can complete this training.

Instructions For Use | 3736 | © 2018 Endotronix Inc. 100474-00 Rev 1
9. Reader/Docking Station Audio &
Visual Cues
Reader Audio Cues
Event Sound Required Action
Searching for
Implant
Two descending beeps,
repeating every ~2
seconds
Reposition Reader to find
stronger signal.
Implant
Located
Four quickly ascending,
high pitched beeps,
repeating three times
Strong signal found. Hold
Reader in place.
Reading in
Progress
Two quickly ascending
beeps, repeating every ~3
seconds
Hold Reader in place (~18
seconds).
Successful
Implant
Reading
Several quickly
ascending, high pitched
beeps
Measurement complete.
Return Reader to Docking
Station.
Failed Reading Several slowly
descending, low pitched
beeps
Reposition Reader to find
stronger signal.
Return to
Docking Station
Successful Reading
sound repeating
periodically
Return to Docking Station.
If Reader is there, check
Docking Station visual
cues.
Low Battery Three quick, low pitched
beeps, repeating every
~10 seconds
When accompanied by
solid yellow light, return to
Docking Station.
Contact
Customer
Support
Three quick, low pitched
beeps, repeating every
~10 seconds
When accompanied by
flashing red light, call
Customer Support.
Reader Visual Cues
Light Event/Required Action
Solid Blue Searching for Sensor.
Slowly Flashing Blue Return to Docking Station.
Rapidly Flashing Blue Sensor located. Ready to begin reading.
Slowly Flashing Green Reading in progress. Hold Reader in place until
light becomes solid green.
Solid Green Successful implant reading.
Rapidly Flashing Yellow Failed reading. Reposition Reader.
Solid Yellow Low battery. Return to Docking Station.
Rapidly Flashing Red Contact Endotronix Customer Support.
Light Off Out of battery. Return to Docking Station.
Docking Station Visual Cues
Light Event/Required Action
Flashing White The Reader is being charged.
Solid White The Reader is fully charged and ready for use.
No Light When the Reader is docked and no light is present, the
Docking Station is not connected to a power source.
Check that the Docking Station Power Cord is plugged
into both Docking Station and the CalEQ power strip and
that the power strip is plugged into an outlet. If the light
remains off, contact Customer Support. To turn off audio
and visual cues from the Reader during this time, press
and hold the small button at the base of the Reader for
several seconds.

Instructions For Use | 3938 | © 2018 Endotronix Inc. 100474-00 Rev 1
10. Maintenance and Storage
10.1 Environmental Information
Store the Delivery System and Cordella Sensor in standard hospital storage
conditions. Keep dry and out of sunlight.
The CalEQ computer, Docking Station, and backup Docking Station should
remain plugged into the power strip. The Reader and backup Reader
should remain in the Docking Stations when not in use. Reference the
Equipment Specifications in Appendix B for specific storage conditions.
The Cordella Sensor and Delivery System are sterilized in a Tyvek pouch.
Tyvek pouches are stored in primary boxes. The primary boxes containing
the sterile Tyvek pouch should be stored in a clean, dry place with other
sterile inventory.
Ensure all parts are clean and dry prior to storage.
10.2 Replacement and Repair
The Cordella Pulmonary Artery Sensor System does not require
maintenance and contains no user serviceable parts . If an issue with the
system appears to require maintenance, contact Endotronix Customer
Support.
To maintain applicable warranties and function, Endotronix requires that
only authorized personnel perform repairs. There are no user serviceable
parts. Repairs made by unauthorized personnel will invalidate your
warranty. For product warranty information, please contact Endotronix.
WARNING: Do not attempt to modify, disassemble, or
otherwise alter any of the system components. If the
system appears to be damaged, contact Endotronix
Customer Support.
If there are defects or damage to any system component, including power
accessories, request a replacement from Endotronix and follow the RMA
process (described below) as requested by Customer Support.
Software configuration of the CalEQ can only be performed by Endotronix
authorized personnel.
11. Disposal
The Cordella Sensor and Delivery System are single use devices. Once the
Cordella Sensor has been deployed from the Delivery System, dispose of
the Delivery System following standard hospital protocols for disposal of
biohazardous materials. If the Cordella Sensor is removed from the patient
for any reason (death, adverse event, etc.), then it should be contained
and shipped to Endotronix following standard protocols for biohazardous
materials. If there is an adverse event or device failure related to the Delivery
System, the affected component should be shipped to Endotronix.
The Reader, Docking Station and CalEQ devices may contain lithium ion
batteries, which should not be discarded with the municipal waste. The
Reader and Docking Station should not be disposed of and instead should
be returned to Endotronix through the RMA process detailed below.
12. Return Materials Authorization (RMA)
If Customer Support requests that the equipment be returned, please
follow the directions below.
1. Check off each item on the equipment return list and carefully pack
the equipment in the original shipping box or equivalent with its
original protective packaging materials.
2. Include the RMA number given to you by Customer Support on the
outside of the shipping container. Ship all equipment and signed
equipment return list to:
RMA #
Customer Support Department, Repairs Endotronix, Inc.
Endotronix, Inc.
815 Ogden Ave.
Lisle, IL 60532
U.S.A.