Use Instructions
Instructions For Use | 4948 | © 2018 Endotronix Inc.
100474-00 Rev 1
radio frequency energy and, if not used in accordance with the instructions,
may cause harmful interference to radio communications. However, there
is no guarantee that interference will not occur in a particular installation.
If this equipment does cause harmful interference to radio or television
reception, which can be determined by turning the equipment off and on,
the user is encouraged to try to correct the interference by one or more of
the following measures:
—Increase the separation between the equipment and receiver.
—Connect the equipment into an outlet on a circuit different from that to
which the receiver is connected.
—Consult Customer Support.
This device complies with part 15 of the FCC Rules. Operation is
subject to the following two conditions: (1) This device may not cause
harmful interference, and (2) this device must accept any interference
received, including interference that may cause undesired operation.
Essential Performance
• Cordella PA Sensor System must not display erroneous diagnostic
data to the treating physician which may result in improper
intervention.
• Acceptance Criteria: The error is less than 3mmHg, or the error is
more than 81.4mmHg, which is not actionable by the physician, or
Cordella PA Sensor System identifies the data as inaccurate and
does not display it to the physician.
• If the Essential Performance is lost or degraded, the user
should continue to take a reading as per usual and the Patient
Management Portal would indicate a bad reading.
Testing
• IEC 60601-1
• ANSI ES 60601-1
• IEC 60601-1-11
• CENELEC EN 60601-1
• CAN/CSA-C22.2 No. 60601-1
• CENELEC EN 60601-1-2
• ETSI EN 301 489-1
• ETSI EN 301 489-17
• ETSI EN 300-330
• CISPR 11
Development and testing for the Cordella Pulmonary Artery Sensor
System has been conducted with the guidance of the following standards
and regulations:
• ISO 10993-1 - Biological evaluation of medical devices – Part 1:
Evaluation and testing within a risk management process
• EN-45502-1 - Active Implantable Medical Devices - Part 1: General
requirements for safety, marking and information to be provided by
the manufacturer
• IEC 60601-1 - Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
• IEC 60601-1-2 - Fourth Edition, Medical electrical equipment – Part
1: General Requirements for Safety – Part 2: Collateral Standard:
Electromagnetic compatibility – Requirements and test
• ISO 14708-1 - Implants for Surgery – Active implantable medical
devices – Part 1: General requirements for safety, marking and
information to be provided by the manufacturer
• ISTA 2A - Packaged Products: 150lb (68kg) or Less
• ISO 11607-1 - Packaging for Terminally Sterilized Medical Devices
• ISO 11135-1 - Sterilization of health care products — Ethylene oxide —
Part 1: Requirements for development, validation and routine control
of a sterilization process for medical devices
Appendix B: Equipment Specications
myCordella™ Reader
Manufacturer: Endotronix
Exclusively for Clinical Investigations.
Method of measurement: Wireless interrogation of implanted Cordella
Sensor
Pulmonary artery pulse pressure maximum range: 40-100 mmHg
Pulmonary artery pressure range at sea level: 0-100 mmHg
Pressure Transducer Accuracy: +/- 7.8 mmHg over full scale range,
for operating conditions between 5° C and 40° C and relative humidity
between 15% and 93%.
Patient safety/use: Typical reading time is 30 seconds.
Calibration: At implant and when deemed necessary by a medical
professional
Expected service life (of Reader only): One year
Safety standards: Meets all relevant parts of IEC 60601-1 Ed. 3.1