Centurion Medical CWHG001 Battery powered, disposable pressure transducer with an integrated display User Manual

Centurion Medical Products Battery powered, disposable pressure transducer with an integrated display Users Manual

Users Manual

Compass® Cast™ and MAPCAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.Indications for UseThe Compass Cast and MAP disposable pressure transducer system with integrated digital display and wireless transmission capability is intended for direct measurement and monitoring of physiologic pressure, including during the infusion of fluids and therapeutic and diagnostic agents.Device DescriptionThe Compass Cast is a self-calibrating, sterile, single-use, disposable, wireless-enabled, physiological pressure transducer with integrated digital display. The Compass Monitor Accessory Plug (Compass MAP) receives the wireless pressure signal from the Compass Cast and inputs the pressure signal to a compatible vital signs monitor.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.Changes or modifications not expressly approved by Centurion Medical Products could void the user’s authority to operate the equipment.Compass CAST FCCID: 2AF4Z-CWHG001Compass MAP FCCID: 2AF4Z-CWM001
Suggested Instructions for Use:Compass Cast Use with Compass MAP 14MONITORPORTMONITORPORT23mm51. Remove Compass MAP from its package.2. Align the multi-pin Compass MAP connectors with the matching port of the compatible* vital signs monitor (Figure 1).3. Insert Compass MAP into a compatible* vital signs monitor (Figure 2) and power on the monitor (if it is not already on). If Compass MAP is already plugged into the patient monitor, either remove and reinsert Compass MAP or power cycle the patient monitor to put Compass MAP into “scanning mode”. (Power cycling can be achieved by turning the monitor off then turning it on again).4. With Compass MAP plugged in and the patient monitor turned on, Compass MAP LED will blink two times every four seconds to indicate that it is scanning for a compatible Compass Cast.5. Zero the pressure signal on the patient monitor per the monitor’s IFU. 6. Remove Compass Cast from its sterile package.7. Remove the proximal luer cap (Figure 3).8. Activate and calibrate Compass Cast by depressing the power button for approximately one second until the LCD reads “00” (Figure 4).WARNING: Activate and auto-calibrate Compass Cast prior to attaching accessories to avoid incorrect baseline pressure.9. The “mm” symbol on the Compass Cast display will blink on and off to indicate that it is searching for a Compass MAP (Figure 5).10. When a wireless connection is established between the Compass MAP and Compass Cast, the “mm” will stop blinking on Compass Cast, and the LED on Compass MAP will switch from flashing to solid.* Compatible vital signs monitors include GE Healthcare and Philips Medical Systems.Compass CAST FCCID: 2AF4Z-CWHG001Compass MAP FCCID: 2AF4Z-CWM001
Suggested Instructions for Use:Compass Cast Use with Compass MAP (concluded) 10910mm811. Depending on the application, attach accessory (e.g. flushing syringe, stopcock, extension or IV tubing, etc.) to the proximal, female luer lock port of the Compass Cast per hospital protocol (Figure 6).12. Depending on the application, connect the distal, male luer lock end of the Compass Cast to accessory (e.g. needle, distal lumen of a central line, extension set or needleless valve in contact with patient) (Figure 7).WARNING: Pressure reading is NOT physiological if either the front or rear of the Compass Cast is open to atmospheric pressure.13. Pressure is displayed on the Compass Cast LCD and the patient monitor (Figure 8).NOTE: If Compass Cast pressure reading does not return to zero after removal from accessories, flush device with saline, open it to atmospheric pressure, and then cycle device (power it off and then power back on) to recalibrate.To Power Off and RecalibratePress and hold button for two seconds until “---” is displayed on the LCD (Figure 9), then release button to power off the device. To recalibrate, depress the power button for approximately one second until the LCD reads “00”.If procedure warrants, insert guidewire (up to 0.038˝ diameter) through the Compass Cast guidewire port and into vessel. Smaller guidewires may necessitate the use of the guidewire insertion tool accompanying the guidewire holder (Figure 10).WARNINGSWhen finished using the Compass Cast, power it off before discarding to prevent inadvertent pairing. Do not reinfuse blood or other bodily fluid into the patient after any such fluid is drawn into the Compass Cast.Do not reuse Compass Cast for different procedures with different patients. Use a new Compass Cast device for each procedure with each patient. 00mm00mm76Compass CAST FCCID: 2AF4Z-CWHG001Compass MAP FCCID: 2AF4Z-CWM001
Suggested Instructions for Use:Compass Cast Use without Compass MAP 1. Remove Compass Cast from its sterile package.2. Remove the proximal luer cap (Figure 1).3. Activate and calibrate Compass Cast by depressing the power button for approximately one second until the LCD reads “00” (Figure 2).WARNING: Activate and auto-calibrate Compass Cast prior to attaching accessories to avoid incorrect baseline pressure.4. Depending on the application, attach accessory (e.g. flushing syringe, stopcock, extension or IV tubing, etc.) to the proximal, female luer lock port of the Compass Cast per hospital protocol (Figure 3).5. Depending on the application, connect the distal, male luer lock end of the Compass Cast to accessory (e.g. needle, distal lumen of a central line, extension set or needleless valve in contact with patient) (Figure 4).WARNING: Pressure reading is NOT physiological if either the distal or proximal luer connections of the device is open to atmospheric pressure.2100mm00mm43Compass CAST FCCID: 2AF4Z-CWHG001Compass MAP FCCID: 2AF4Z-CWM001
Suggested Instructions for Use:Compass Cast Use without Compass MAP (concluded) 6. Pressure is displayed on the Compass Cast LCD (Figure 5).NOTE: If Compass Cast pressure reading does not return to zero after removal from accessories, flush device with saline, open it to atmospheric pressure, and then cycle device (power it off and then power back on) to recalibrate. To Power Off and RecalibrationPress and hold button for two seconds until “---” is displayed on the LCD (Figure 6), then release button to power off the device. To recalibrate, depress the power button for approximately one second until the LCD reads “00”.7. If procedure warrants, insert guidewire (up to 0.038˝ diameter) through the Compass Cast guidewire port and into vessel. Smaller guidewires may necessitate the use of the guidewire insertion tool accompanying the guidewire holder (Figure 7).WARNINGSDo not reinfuse blood or other bodily fluid into the patient after any such fluid is drawn into the Compass Cast.Do not reuse Compass Cast for different procedures with different patients. Use a new Compass Cast device for each procedure with each patient. 7610mm5Compass CAST FCCID: 2AF4Z-CWHG001Compass MAP FCCID: 2AF4Z-CWM001
Connectivity DetailsWhen Compass MAP enters scanning mode after being powered on with the connection to a patient monitor, it will select the strongest available Compass Cast signal.Once a Compass Cast and a Compass MAP are paired, the devices will no longer be able to pair with other Compass devices unless they are power cycled to force them back into general scanning mode.If the connection is temporarily lost (e.g. because the Compass MAP is disconnected and therefore powered down, and reattached to a different patient monitor), the previously paired devices will automatically reinitiate a connection.If the Compass Cast is used without the Compass MAP, after 10 minutes of broadcasting without a paired connection, Compass Cast will no longer advertise and the “mm” displayed will change from flashing to off.If Compass Cast is unable to establish a wireless connection, after 10 minutes of broadcasting, Compass Cast will no longer advertise and the “mm” displayed will change from flashing to off. The device must be power cycled for it to restart advertising for a wireless connection.Once a Compass MAP has established a wireless connection to a Compass Cast, it will only pair to that particular Compass Cast. The Compass MAP must be power cycled to have it search for any available Compass Cast.Device Power O and RecalibrationCleaning InstructionsPress and hold button for two seconds until “---” is displayed on the LCD, then release button to power down device. The Compass MAP, the data receiver and monitor interface, is non-patient contacting and intended for multiple uses. 1. Inspect the Compass MAP for signs of damage, wear, or abuse.2. Do not use if worn or damaged, e.g. connection pins bent or missing, or if the casing seal’s integrity is compromised. 3. The Compass MAP may be low-level disinfected per hospital protocol. 4. Do not immerse Compass MAP in solutions.5. Do not super saturate the cloth or the device. 6. Avoid liquid contact with the pin connectors.7. Do not use abrasive or scouring materials.8. Do not use staining solutions.Compass CAST FCCID: 2AF4Z-CWHG001Compass MAP FCCID: 2AF4Z-CWM001
SpecificationsPressure Range ..................................................... -199 mm to +999 mm HgCompass MAP Output ........................................... 25 μV per mm HgAccuracy: Compass LCD ....................................... ±2 mm Hg below 50 mm Hg ±3% of reading above 50 mm HgAccuracy: Compass MAP ...................................... ±2% below 50 mm Hg ±3% of reading above 50 mm HgZero Drift ............................................................... ±1 mm Hg per 4 hoursOperating Life ....................................................... > 8 hours Operating Temperature ......................................... 15° to 40°C (59° - 104°F) Storage Temperature ............................................ -29° to 49°C (-20° - 120°F)Light Sensitivity ..................................................... < 1 mm HgLithium Ion Battery Voltage ................................... 3 VoltsDisplay+ symbol for positive pressure - symbol for negative pressureBar 1 =1 mm HgBar 12 =12 mm HgBar 36 = 149 mm HgBar 18 = 42 mm HgPressure Unit = mm HgNumerical Display Modes:•Display updates 2 times/secGraphical Waveform:Variable scaling to enhancephysiologic pulsationBars 1–12: 1 mm Hg/barBars 13–18: 5 mm Hg/barBars 19–36: 6 mm Hg/barCompass CAST FCCID: 2AF4Z-CWHG001Compass MAP FCCID: 2AF4Z-CWM001
Compass Cast and MAP IFU_E 0707-16 ©2016 Centurion Medical Products CorporationCompass Cast: Software CodesUF Bluetooth Radio Check FailureSF Software FailureHF Hardware FailurebF Battery Failure EE Environment Error - Device outside operating temperatureCE Calibration Error – Pressure values outside operating rangeLb3 Less than 8 hours battery life remainingLb2 Less than 6 hours battery life remainingLb1 Less than 4 hours battery life remainingLb0 Less than 2 hours battery life remainingCompass MAP: LED CodesSolid LED........................................................................ Wireless connection establishedTwo Flashes Every Four Seconds ................................... Scanning for wireless connectionFlashing Sixteen Times Per Second ................................ Compass MAP non-functionalCompass CAST FCCID: 2AF4Z-CWHG001Compass MAP FCCID: 2AF4Z-CWM001

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