User Manual

6
© 2019 Endotronix® Inc. 100469-00 Rev. 2
Safety Information
To prevent personal injury or damage to any equipment, please read
and observe all safety information.
Warnings
• The Reader is suitable for home healthcare environments and professional healthcare
facilities except for near active HF surgical equipment and the RF shielded room of an ME
system for magnetic resonance imaging, where the intensity of 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. If necessary, contact customer service to help re-locate the system.
• DO NOT expose any power accessories to water or other liquids.
• DO NOT disassemble or modify any component of the Cordella™ PA Sensor System.
• DO NOT use myCordella™ in the presence of explosive or flammable anesthetic agents.
• The Cordella™ PA Sensor System is not intended for emergency use or real-time monitoring.
• The Cordella™ PA Sensor System is not intended to be an emergency response device. In case
of a medical emergency, call the local Emergency Medical Services and/or your healthcare
provider.
• After the implantation procedure, it is critical to adhere to prescribed anticoagulation and
other medications from the physician.
• Power cables may pose a tripping hazard. Be mindful of cords crossing walkways.
• myCordella™ Patient Reader may be interfered with by other equipment generating
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 (450MHz devices) within ~10 feet/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, remove or stop using the interfering equipment.
• Use only the cables and accessories provided. The use of accessories, transducers or cables
other than those specified or provided as replacement parts, may result in decreased
immunity of the system, inaccurate readings, damage to the system, injury to user, or
improper operation.
• Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than ~5 feet/1.5 meters to any part of the
Reader. Otherwise, degradation of the performance of the Reader could result.
• 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 service.
Warnings
This symbol indicates “the possibility of system
damage or malfunction, delay in receipt of
information to a doctor, inaccurate readings, or
injury.”
Precautions
This symbol indicates “the possibility of system
damage, malfunction, or the delay in treatment.”