Centurion Compass Cast, Compass MAP User Manual

Compass® Cast™ and MAP
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
Indications for Use
The 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 Description
The 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-CWHG001 Compass MAP FCCID: 2AF4Z-CWM001
Suggested Instructions for Use: Compass Cast Use with Compass MAP
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MONITOR
PORT
MONITOR
PORT
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1. 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-CWHG001 Compass MAP FCCID: 2AF4Z-CWM001
Suggested Instructions for Use: Compass Cast Use with Compass MAP (concluded)
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11. 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 Recalibrate
Press 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).
WARNINGS
When 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.
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00
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Compass CAST FCCID: 2AF4Z-CWHG001 Compass MAP FCCID: 2AF4Z-CWM001
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