Technical Description PressureWireTM AerisTM Technical Specifications Pressure range Pressure accuracy Frequency response Radio range Battery time transmitter Frequency range Radio type Radio power Total signal time delay -30 to +300 mmHg ±1 mmHg plus ± 1% (<50 mmHg) ± 3% (>50 mmHg) DC to 25 Hz 2 m* 3 hours 2.4000-2.4835 GHz (ISM band) Frequency hopping spread spectrum (FHSS) 1 mW peak, 70 μW average <10 ms Hydrophilic coated 0.014” pressure guidewire *15-20 m in free line of sight 2 Detachable transmitter PressureWire™ Receiver PressureWire Aeris The Guidewire component is identical to PressureWire™ Certus™ Hydrophilic coating for low friction, increased device compatibility and increased overall maneuverability Strengthened core wire provides excellent torque response and intermediate support Proximal male connector is hydrophobic which repels moisture and ensures high reliability and good signal quality even after several reconnections* 3 PressureWire Aeris Transmitter Battery-operated, disposable (contaminated material) Communicates via radio with PressureWire Aeris Automatically zeroes pressure when turned on Do not turn off the transmitter while inside body, as this would require removal from the body and re-zeroed Normal battery operating time 3 hours Turn cap counter-clockwise 90° to remove guidewire Transmitter 4 PressureWire Aeris Transmitter - Light Indicators Light Indicator 5 Cause Green steady light Transmitter on Green pulsating light Normal operation Pulsation proportional to blood pressure Yellow steady light PressureWire disconnected from transmitter. Re-insert PressureWire firmly into transmitter Green pulsating light & yellow slow blinking light Battery level low: o Finish procedure or exchange PressureWire Aeris Yellow fast blinking light Error: Possible cause oCalibration error o Battery level too low for operation o Internal error Attempt restart by removing PressureWire from body and turn the transmitter off and on again No light oNot turned on oBattery dead PressureWire Aeris Receiver Radio receiver for pressure from PressureWire Aeris Connects directly to a free pressure port in the hemodynamic recording system PressureWire Receiver is mounted permanently on the horizontal cath lab table rail or on a vertical instrument pole Pressure and FFR measurement is displayed on existing screens of recording system in control room and in cath lab PressureWire Receiver is powered by the recording system front end and requires no extra connection or battery PressureWire Receiver Recording system front end PressureWire Aeris P2 P1 AO-transducer 6 Hemodynamic recording system PressureWire Aeris Receiver “Plus” button • Increase pressure offset by +1 mmHg or increase reference level output in Refout mode “Connect” button • Press once to connect to PressureWire Aeris • Press and hold >3 s to enter Refout mode • In Refout mode, press once to exit “Minus” button • Decrease pressure offset by -1 mmHg or decrease reference level output in Refout mode 7 PressureWire Aeris Receiver - Light Indicators Light Indicators + - + - Yellow steady light At startup: Unit power on and self test passed During measurement: Wire disconnected from transmitter or lost connection to PressureWire Aeris Green blinking light Connect mode – searching for connection to PressureWire Aeris Green steady light Established connection to PressureWire Aeris receiving pressure Incremental green lights Reference pressure level output (Refout). o Press plus/minus to change level: 0-2040-100-200 mmHg Plus or minus indicators steady blue Positive or Negative pressure offset added to PressureWire Aeris pressure Green steady light & yellow blinking light Yellow blinking light 8 Cause PressureWire Aeris battery level low o Finish procedure or exchange PressureWire Aeris Internal error o Attempt restart by disconnecting then reconnecting PressureWire Receiver from cath lab recording system Radio Technology PressureWire Aeris utilizes advanced radio technology to ensure a stable and secure communication and avoid disturbing other systems. 1. 2. 3. 4. 5. PressureWire Transmitter and PressureWire Receiver lock to each other at calibration using a unique identification code PressureWire Receiver stores the last connected PressureWire Aeris in its memory In the event of power failure PressureWire Receiver resumes communication Uses “Frequency Hopping Spread Spectrum” technology (FHSS), to avoid interference with or disturbance from other systems in the cath lab Transmits using very low radio power PressureWire Receiver . . . PressureWire Transmitter 400 hops/s 9 79 channels FAQ – Radio Technology Will the radio signal be disturbed by mobile phones, computer networks, X-ray etc? No. PressureWire Aeris utilizes an advanced radio technology called "frequency hopping" where the information is sent several times using multiple radio frequencies. The system changes radio frequency 400 times per second which means that even if there are several interfering radio sources, it will locate alternate frequencies. Extensive, real-life cath lab testing revealed no radio frequency interruption. 10 FAQ – Radio Technology Can PressureWire Aeris cause disturbances to other cath lab systems? PressureWire Aeris is designed to interfere as little as possible with other radio devices The transmitted radio power is very low - max 1 mW (0.001), average 70 μW (0.000070) which is 1000 to 10.000 times lower than the power from a normal cellular phone The frequency hopping technique further reduces the risk by transmitting on each frequency for only a very short time The system is completely in-active until a PressureWire Aeris is being used. The lead enclosure in cath labs also reduces the amount of radio power emitted from the lab. PressureWire Aeris has passed all radio acceptance tests by US FCC and EU R&TTE. 11 FAQ – Radio Technology Can several PressureWire Aeris systems be used at the same time in the same environment? Yes. At the start of a procedure PressureWire Aeris locks to its Receiver using a built in unique identifier code The PressureWire Receiver can only receive pressure from one connected wire regardless of any other PressureWire Aeris Systems used in the same environment The frequency hopping scheme is random which means that several pairs of wires and receivers can communicate in the same environment without disturbing each other 12 FAQ – Batteries Can the transmitter - including batteries - be disposed of using regular hospital protocol for contaminated waste,with the batteries? Yes. The batteries have very low mercury levels, and since the transmitter is contaminated by blood, the transmitter with batteries should be disposed of following standard hospital protocol for contaminated waste. 13 Rx Only Product referenced is approved for CE Mark Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use. PressureWire is designed, developed and manufactured by Radi Medical Systems AB. Patent Pending. Unless otherwise noted, ™ indicates a registered or unregistered trademark or service mark owned by, or licensed to, St. Jude Medical, Inc. or one of its subsidiaries. PressureWire, RADI, ST. JUDE MEDICAL, the nine-squares symbol, and MORE CONTROL. LESS RISK. are registered and unregistered trademarks and service marks of St. Jude Medical, Inc. and its related companies. ©2010 St. Jude Medical, Inc. All rights reserved. 14