User Manual

Appendix B: Equipment Specifications

myCordella™ Patient Reader

Manufacturer: Endotronix®

CAUTION--Investigational device. Limited by Federal (or United States) law to

investigational use.

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 15°C and 30°C and relative humidity between

6% 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

EMC standards: Meets all relevant parts of IEC 60601-1-2 Ed. 4.0

Operating frequency: 12.88-14.12 MHz, 2.45 GHz

Essential performance is maintained for the service life of the product. For

additional information regarding essential performance contact Endotronix

customer service.

Physical

Approximate dimensions

• Width: 6.44 in / 16.35 cm

• Height: 2.0 in / 5.1 cm

• Depth: 5.63 in / 14.3 cm

• Weight: 1.1 lbs / 0.5 kg

Power

Input of 4.2V/16.8V 925mA/250mA

Environment

The Reader may not meet its performance specifications if stored or used

outside the temperature and humidity ranges listed below.