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

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Document ID	3107745
Application ID	sw4xOOlVvUm7aSl8gCEi+w==
Document Description	Users Manual
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	85.55kB (1069346 bits)
Date Submitted	2016-08-22 00:00:00
Date Available	2016-09-09 00:00:00
Creation Date	2016-07-07 15:17:16
Producing Software	Adobe PDF Library 10.0.1
Document Lastmod	2016-07-07 15:17:23
Document Title	Users Manual
Document Creator	Adobe InDesign CS6 (Macintosh)

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
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).
M O N ITO R
PORT
3.	Insert Compass MAP into a compatible* vital signs
monitor (Figure 2) and power on the monitor
(if it is not already on).
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.
M O N ITO R
PORT
	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).
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
mm
Suggested Instructions for Use:
Compass Cast Use with Compass MAP (concluded)
mm
00
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).
mm
00
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.
10
mm
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.
Compass CAST FCCID: 2AF4Z-CWHG001
Compass MAP FCCID: 2AF4Z-CWM001
10
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).
mm
WARNING: Pressure reading is NOT physiological if either
the distal or proximal luer connections of the device is
open to atmospheric pressure.
00
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).
mm
00
Compass CAST FCCID: 2AF4Z-CWHG001
Compass 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).
10
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 Recalibration
mm
Press 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).
WARNINGS
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.
Compass CAST FCCID: 2AF4Z-CWHG001
Compass MAP FCCID: 2AF4Z-CWM001
Connectivity Details
When 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 Off and Recalibration
Press and hold button for two seconds until “---” is displayed on the LCD, then release button
to power down device.
Cleaning Instructions
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-CWHG001
Compass MAP FCCID: 2AF4Z-CWM001
Display
Bar 18 = 42 mm Hg
+ symbol for positive pressure
- symbol for negative pressure
Bar 12 =
12 mm Hg
Bar 36 = 149 mm Hg
Bar 1 =
1 mm Hg
Graphical Waveform:
Numerical Display Modes:
Variable scaling to enhance
physiologic pulsation
•
Display updates 2 times/sec
Bars 1–12: 1 mm Hg /bar
Bars 13–18: 5 mm Hg/bar
Bars 19–36: 6 mm Hg/bar
Pressure Unit = mm Hg
Specifications
Pressure Range......................................................
-199 mm to +999 mm Hg
Compass MAP Output............................................
25 μV per mm Hg
Accuracy: Compass LCD........................................
±2 mm Hg below 50 mm Hg
±3% of reading above 50 mm Hg
Accuracy: Compass MAP.......................................
±2% below 50 mm Hg
±3% of reading above 50 mm Hg
Zero Drift................................................................
±1 mm Hg per 4 hours
Operating 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 Hg
Lithium Ion Battery Voltage....................................
3 Volts
Compass CAST FCCID: 2AF4Z-CWHG001
Compass MAP FCCID: 2AF4Z-CWM001
Compass Cast: Software Codes
UF
Bluetooth Radio Check Failure
SF
Software Failure
HF
Hardware Failure
bF
Battery Failure
EE
Environment Error - Device outside operating temperature
CE
Calibration Error – Pressure values outside operating range
Lb3
Less than 8 hours battery life remaining
Lb2
Less than 6 hours battery life remaining
Lb1
Less than 4 hours battery life remaining
Lb0
Less than 2 hours battery life remaining
Compass MAP: LED Codes
Solid LED........................................................................
Wireless connection established
Two Flashes Every Four Seconds....................................
Scanning for wireless connection
Flashing Sixteen Times Per Second.................................
Compass MAP non-functional
Compass CAST FCCID: 2AF4Z-CWHG001
Compass MAP FCCID: 2AF4Z-CWM001
Compass Cast and MAP IFU_E 0707-16
©2016 Centurion Medical Products Corporation

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