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© 2019 Endotronix® Inc.

100469-00 Rev. 2

APPENDICES

Appendix A: Cordella

™

Pulmonary Artery Sensor System Components

Use only supplies authorized by Endotronix®, as other equipment may
result in increased electromagnetic emissions, decreased immunity to
emissions, or damage to the system. To order supplies, contact
customer service and include the part number and name.

Endotronix, Inc.
815 Ogden Ave
Lisle, IL 60532
USA
[email protected]

Cordella™ Pulmonary Artery Sensor System Component

List

100102-00

myCordella Patient Reader

100274-00

myCordella Docking Station

100264-00

Docking Station AC/DC Wall Mount Adapter

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Summary of Contents for my cordella

Page 1: ...HE CORDELLA PULMONARY ARTERY SENSOR SYSTEM CAUTION Investigational device Limited by Federal or United States law to investigational use 815 Ogden Ave Lisle IL 60532 www endotronix com 1 888 512 5595 Endotronix Ireland Limited DCU Alpha Innovation Centre Old Finglas Road Glasnevin Dublin 11 D11 KXN4 Ireland ...

Page 2: ...2 2019 Endotronix Inc 100469 00 Rev 2 this page left blank intentionally ...

Page 3: ...eader Placement 10 Taking a Reading 11 Audio Visual Cues 13 Reader Audio Cues 13 Reader Visual Cues 13 Docking Station Visual Cues 14 Traveling with the myCordella Patient Reader and Docking Station 14 Contact Us 15 Repairing Equipment 15 Return Materials Authorization RMA 16 Inspection Cleaning Instructions 16 MRI Conditions 17 APPENDICES 18 Appendix A Cordella Pulmonary Artery Sensor System Comp...

Page 4: ...anted in a vessel between the heart and lungs When you take a measurement the Cordella Sensor sends a signal which indicates the pressure in the artery Changes in PA pressure may indicate fluid accumulation in the lungs By watching the trends in your PA pressure your healthcare providers may intervene to address the increasing pressure before you have symptoms This information along with your othe...

Page 5: ...ssure readings to your clinician on the myCordella Patient Management Portal enabling a more complete picture of your health status myCordella Docking Station Docking Station Small stand that conveniently holds and charges the Patient Reader while you are not using it The Reader should always remain in the Docking Station unless it is in use or it is packed for traveling LED lights on the front wi...

Page 6: ...enerating electromagnetic fields When possible avoid using the system while simultaneously using the equipment within 5 feet 1 5 meters such as laptop computers tablets e readers cell phones cordless phones wireless routers hair dryers electric shavers refrigerators home stereos alarm clock radios air conditioners electric ovens washers dryers dishwashers televisions microwaves or walkie talkies 4...

Page 7: ... change in body temperature 3mmHg C Accuracy of the Cordella PA Sensor System is slightly affected by large changes in elevation between the initial baseline calibration and subsequent measurements Readings may lose accuracy when taken 2000m of elevation The Cordella Sensor is a permanent implant Removing the implant after implantation is not recommended The Cordella Sensor may be affected by a ch...

Page 8: ...ed to your PA by your doctor The steps of the implant procedure are 1 You may be mildly sedated to start but your doctor will likely need you awake during certain parts of the procedure to follow instructions 2 A nurse will clean the access site and will numb it with a local anesthetic 3 You will be monitored by an electrocardiogram with sensors on different areas of your body to measure electrica...

Page 9: ...onary catheter will be used to take some simultaneous reference pressure measurements to calibrate the new Sensor 9 Following the removal of all catheters the access site will be closed leaving the Cordella Sensor in the PA After the Implant Procedure Once the procedure is complete you will be brought to a recovery area While in the recovery area a staff person will come by to take some PA pressur...

Page 10: ...nge to solid white when the Reader is charged Call Endotronix customer service if this does not occur within 24 hours of setup The Reader is distributed in Travel Mode Start the Reader for the first time by holding the travel button on the bottom for several seconds Reader Placement Reliably and repeatedly finding proper Reader location is essential to collecting valid PA pressure measurements Pos...

Page 11: ... the LED indicator on the Reader use a mirror or ask a caregiver to describe it as you take the reading The animation walks you through proper data collection using the Reader Briefly 1 Check to ensure the LED light on the front of the Docking Station indicates a battery charge that will allow for the reading to be completed The LED on the Docking Station should be solid white when the Reader is f...

Page 12: ...eturn to Search mode described in step 2 6 Once a good reading is obtained the Reader will be a solid GREEN and will continue to play the Success tone until it is returned to the Docking Station The Reader should always remain docked unless it is being used or transported Submit Results The tablet screen will either return to the Take A Test screen or you may tap the Continue button which will app...

Page 13: ... 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 Service Three quick low pitched beeps repeating every 10 seconds When accompanied by flashing red light call Cust...

Page 14: ...l Endotronix recommends carefully packing the Patient Reader in a carry on suitcase by wrapping the Reader in bubble wrap or clothing and storing in the center of the suitcase The Docking Station and power cord should be wrapped separately and also be stored in a suitcase where it will be under the least amount of stress To travel with the Reader remove the Reader from the Docking Station and pres...

Page 15: ...inquiries can be directed to the contact information below Endotronix Customer Service Toll free 1 888 512 5595 Support endotronix com Repairing Equipment 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 infor...

Page 16: ...e IL 60532 USA Inspection Cleaning Instructions Inspect the system regularly No maintenance is required If any of the inspection checkpoints apply please contact customer service Inspection Checklist o Power cord is not frayed or connected to unauthorized equipment If there is a frayed power cord or if the unit is attached to unauthorized equipment unplug the unit and notify customer service to ob...

Page 17: ...id o DO NOT spray liquids directly on the Reader or Docking Station use a pre moistened cloth o DO NOT autoclave o DO NOT sterilize with ethylene oxide MRI Conditions MRI Information o You can have an MRI scan under certain conditions Talk with the clinician ordering your MRI scan to ensure that he or she knows that you have a Cordella PA Sensor o If defined MRI conditions are not followed there i...

Page 18: ...tromagnetic emissions decreased immunity to emissions or damage to the system To order supplies contact customer service and include the part number and name Endotronix Inc 815 Ogden Ave Lisle IL 60532 USA Info endotronix com Cordella Pulmonary Artery Sensor System Component List 100102 00 myCordella Patient Reader 100274 00 myCordella Docking Station 100264 00 Docking Station AC DC Wall Mount Ada...

Page 19: ...ading 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 additi...

Page 20: ... CAUTION Investigational device Limited by Federal or United States law to investigational use Expected service life One year Physical Approximate dimensions Width 5 5 in 14 0 cm Height 2 5 in 6 4 cm Depth 5 5 in 14 0 cm Weight 0 4 lbs 181 4 g Power Cord Cord length 8 feet 2 4 m AC Power Wall mount style power supply Input of 110 250V 50 60 Hz Output of 5V 3A Manufacturer SL Power Electronics Part...

Page 21: ...2 Ed 4 0 The Reader and Docking Station are intended for use in the electromagnetic environment specified below Immunity Test Test Level Compliance Electromagnetic Environment Guidance Electrostatic Discharge Immunity IEC 61000 4 2 8kV contact 2kV 4kV 8kV 15kV air 8kV contact 2kV 4kV 8kV 15kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relat...

Page 22: ...ycles 50Hz and 300 cycles 60Hz 0 UT 100 interruption in UT for 250 cycles 50Hz and 300 cycles 60Hz Power Frequency Magnetic Field IEC 61000 4 8 30A m 50Hz and 60Hz 30A m 50Hz and 60Hz Power frequency magnetic fields should be at levels characteristic of a typical professional healthcare facility or home healthcare environment Radiated RF Immunity IEC 61000 4 3 10V m 80MHz 2 7GHz 80 AM at 1kHz 10V ...

Page 23: ...he electromagnetic environment due to fixed RF transmitters and electromagnetic site survey should be considered If the measured field strength in the location in which the myCordella is used exceeds the applicable RF compliance level above the myCordella should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or re...

Page 24: ... center bands 13 09MHz 13 34MHz 13 62MHz and 13 9MHz BT Transceiver frequency BT Smart Ready Module FCC ID QOQBT121 Operating Frequency Range 2402MHz 2480MHz FCC Statement The equipment is approved for wireless transmission under FCC ID 2AR87ETXCPAS01 It has been tested and found to comply with the limits for a Class B digital device pursuant to part 15 of the FCC Rules These limits are designed t...

Page 25: ...s 1 This device may not cause harmful interference and 2 this device must accept any interference received including interference that may cause undesired operation 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 ...

Page 26: ...ber so that a specific medical device can be identified Authorized representative in the European Community Need for the user to consult the instructions for use Medical device that needs protection from light sources or heat Temperature limits to which the medical device can be safely exposed Range of atmospheric pressure to which the device can be safely exposed Device that needs to be protected...

Page 27: ...ngress protection where N1 degree of protection from particulates scale of 0 6 and N2 degree of protection from water scale of 0 8 IP21 Protected against solid foreign objects of 12 5 mm and greater and against the effects of dripping water IP22 Protected against solid foreign objects of 12 5 mm and greater and against the effects of dripping water when tilted at 15 Device has been demonstrated to...

Page 28: ...28 2019 Endotronix Inc 100469 00 Rev 2 Cordella myCordella and Endotronix are trademarks of Endotronix Inc 2019 Endotronix Inc All rights reserved ...

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