C3 WAVE Quick Reference Guide v1.0 Jan 2020

P-Wave and Catheter Placement “Position the tip of a CVAD in the lower segment of the superior vena cava at or near the CAJ for adults and children” (INS 2016)

FPO - need hi res Pulled from Word doc. Need to replace here and in #6309

No evident P wave changes indicates catheter is not in acceptable position

1

A P wave at its max height will indicate the catheter is in the lower 1/3 of the SVC

A downward deflection edge of P wave indicated the catheter is entering the RA

A biphasic P wave indicated the catheter is in the RA

An inverted P wave indicated catheter is approaching the right ventricle

Alexander M. Infusion Standards. Journal of Infusion Nursing. 2016;39(4):181-182.

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C3 WAVE

Bluetooth® Pairing

HUB BLUETOOTH® PAIRING

REMOTE BLUETOOTH® PAIRING

Press and hold the power button for about 8 seconds. The blue power LED will flash rapidly to indicate that the hub has erased pairing information.

Press and hold all four arrow buttons for about 5 seconds. This will remove all pairing information from the remote.

On the new iPad go to Settings & Support and press the “Pair” icon under Hub Serial # ®

On the hub press and hold the power button for 2 seconds until the blue LED begins to flash slowly. On the iPad press the area marked “Chest Hub”. This will pair the hub with the iPad®. ®

You can verify that the hub has paired correctly by checking that the serial numbers match.

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On the new iPad® go to Settings & Support and press the “Pair” icon under Remote Serial # On the remote press any button and the blue remote LEDs will begin to flash slowly. On the iPad® press the area marked “Remote”. This will pair the remote with the iPad®. You can verify that the remote has paired correctly by checking that the serial numbers match.

C3 WAVE

Warning Screen Pop-Ups WARNING

CONDITION

PERSISTENCE

PICC Lead Off

PICC lead disconnected from the patient. App in "internal mode".

Skippable cleared by pressing "Dismiss"

ECG Lead Off

ECG lead disconnected from the patient.

Skippable cleared by pressing "Dismiss"

Internal System Error

I2C bus failure

Unskippable cleared by power cycling the device

Charger Error

Battery charger failure

Unskippable cleared by removing and re-inserting the DC power connector

Internal Power Error

3.3V power rail goes below 3.1V

Unskippable cleared by power cycling the device

Hub Disconnected

Wireless connection with the hub is lost

Unskippable cleared by reconnecting the hub

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SCREENSHOT

C3 WAVE

Warning Screen Pop-Ups WARNING

CONDITION

PERSISTENCE

Hub Low Battery

Hub battery is below 50%

Skippable cleared by pressing “Dismiss”

Hub Critical Battery

Hub battery is below 20%

Skippable cleared by pressing “Dismiss”

Remote Low Battery

Remote battery level is below 50%

Skippable cleared by pressing “Dismiss”

Remote Critical Battery Remote battery level is below 20%

Skippable cleared by pressing “Dismiss”

Hub Charging

Hub is charging via charging base or power supply

Unskippable cleared by unplugging or removing hub from charging base

Informational Message: “…confirm entry…”

Low [Grey]

Confirm selected action, such as “Finish Case”, or “Delete File”

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SCREENSHOT

N/A

C3 WAVE

Troubleshooting PROBLEM

CAUSE

SOLUTION

Hub will not power on

Battery fully discharged

Charge the hub

Power button not held long enough

Press and hold the power button for 2 - 5 seconds until the button begins to flash

Hub is charging and connected to the app for a procedure

Charge the hub and remove it from the charger before going into the app to start a procedure

Hub will not turn off

Power button not held long enough

Press and hold the power button for 2 - 5 seconds until the button begins to flash

Hub will not connect

Hub is off

Press and hold the power button for 2 - 5 seconds

Not in a procedure

The hub and remote only connect on a new procedure

Hub not paired

See “Pairing Hub with App” for instructions

Bluetooth® turned off

In the iPad settings screen make sure that Bluetooth® is on

Hub power connector not inserted

Make sure the hub power connector is securely inserted

Power adapter not plugged into the wall

Make sure the power adapter is plugged into the wall

Outlet does not have power

Make sure AC power is present at the outlet

Hub not seated on the charging cradle

Make sure the hub is fully seated in the charging cradle

Batteries over-discharged

If the LED shows solid red when charging replace the batteries

No batteries present

Verify that approved medical grade batteries have been installed

Hub will not charge – no charge LED

Hub will not charge – solid red charge LED

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C3 WAVE

Troubleshooting PROBLEM

CAUSE

SOLUTION

Remote will not power on

Batteries drained

Replace batteries

Remote powers on but will not connect (continuous flashing)

Remote not paired

See “Pairing Remote with App” for instructions

Not in a procedure

The hub and remote only connect on a new procedure

Bluetooth® turned off

In the iPad settings screen make sure that Bluetooth® is on

ECG lead disconnected

Check that each ECG lead is connected to the hub and to an ECG pad

ECG pads loose

Check that the ECG pads are firmly attached to the patient

Old ECG pads

Replace with new ECG pads

Mismatched ECG pads

Make sure the ECG pads are from the same package and are placed at the same time

Misplacement of pads

Verify that the pads have been placed in the correct location

Improper skin preparation

Clean the ECG placement location with an alcohol pad before placing the electrodes

Bad skin to electrode contact

When applying ECG pads press firmly against the patient to ensure good contact between the electrode and the skin

No ECG signal (with a warning message E205)

Poor quality ECG or PICC signal

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C3 WAVE

Troubleshooting PROBLEM

CAUSE

SOLUTION

No PICC signal (with a warning message E202)

ECG lead disconnected

Check that each ECG lead is connected to the hub and to an ECG pad

ECG pads loose

Check that the ECG pads are firmly attached to the patient

PICC lead disconnected

Check that the ECG pads are firmly attached to the patient

Poor blood contact

Flush the PICC and wait about 30 seconds for signal capture

No PICC or ECG Signal (no warning message)

Hub incorrectly paired

Exit the app and open the iPad settings. Select Bluetooth® and under “My Devices” press the next to each item marked “Chest hub”. Select “Forget Device” for each item. On the hub press and hold the power button until it flashes rapidly (about 8 seconds). Re-pair the hub (see “Pairing the Hub” for instructions).

ECG Wave Inverted

Leads connected to pads in correctly

Verify that each lead is connected to the correct pad

Leads connected to hub incorrectly

Verify that each lead is connected to the correct port on the hub

Cannot find the printer wireless access point in the iPad settings

See “Configuring the Printer” for instructions

Cannot find the printer in the app print menu

Make sure that the iPad is connected to the printer. Wait 60 seconds and attempt to print again.

Unable to print

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C3 WAVE

Troubleshooting PROBLEM

CAUSE

SOLUTION

iPad/App slow or crashing

Insufficient battery

Plug the printer into a wall outlet or charge the battery

No paper

Insert a label roll into the printer

Failed to retrieve printer status

Verify that a compatible printer is connected. Power cycle the printer

Overheating error

Allow the printer to cool down for 15 minutes

Paper jam

Open the lid and clear the paper jam

Replace paper cassette while printing.

Check that the label has been loaded correctly and that the printer has paper

Internal system error (E201) displayed

Feeding error or end of paper

Check that the label has been loaded correctly and that the printer has paper

Internal power error (E208) displayed

Please load the label roll (DK-2205)

Insert a label roll into the printer

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Charging circuit error (E206) displayed

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C3 WAVE

Consult your AngioDynamics representative for country specific product availability.

IMPORTANT RISK INFORMATION INTENDED USE/ INDICATIONS FOR USE: The C3 Wave System is indicated for use in the positioning of Peripherally Inserted Central Catheters (PICC). The C3 Wave provides real-time catheter tip location information by displaying changes in the patient’s cardiac electrical activity. The C3 Wave is indicated for use as an alternative method to chest X-ray or fluoroscopy confirmation of PICC tip placement in adult patients. NOTE: Limiting, but not contraindicated, situations for this technique are patients where cardiac rhythms may change presentation of the P-Wave: • Atrial fibrillation • Atrial flutter

• Severe tachycardia • Pacemaker-driven rhythm

• Chronic obstructive pulmonary disorder (COPD)

Such patients are easily identified prior to PICC insertion. Use of an additional confirmation method is necessary to confirm catheter tip location. WARNINGS: The C3 Wave™ System works with the normal sinus rhythm of the heart. Do not rely on ECG signal detection for catheter tip positioning when interpretation of the external or intravascular ECG P-wave is difficult. For example, when: • P-wave is not present • P-wave is not identifiable • P-wave is intermittent •Place ECG adhesive electrodes carefully at locations indicated in these Instructions for Use and ensure good skin-electrode contact. Failure to do so may cause unstable ECG waveforms and/or ECG waveforms that are not described in these Instructions for Use • All components in the accessory pack are single use items. Do not reuse or reprocess • Monitor catheter tip placement during insertion procedure and verify catheter tip location placement using your institutions’ guidelines. • Failure to verify catheter placement may result in serious trauma or fatal complications. • Inspect package and product prior to use to verify that no damage has occurred during shipping. • Reuse or reprocessing may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. • Reuse or reprocessing may also create a risk of contamination of the device and/ or cause patient infection or cross- infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. • Contamination of the device may lead to injury, illness or death of the patient. • After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy. Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications. CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

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+31 20 753 2949 AngioDynamics, Inc. and the AngioDynamics logo are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or subsidiary. C3 Wave and the C3 Wave logo are trademarks and/or registered trademarks of AngioDynamics VA LLC. All other trademarks are property of their respective owners. © 2020 AngioDynamics VA LLC. GL/VA/MS/30 (v1.0) 01/2020

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