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AngioDynamics C3 WAVE SYSTEM Owner's Manual

Ecg-based tip confirmation system
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Manufactured for:
AngioDynamics, Inc.
26 Forest Street
Marlborough, MA 01752 USA
USA Customer Service 800-772-6446
EU Authorized
Representative:
AngioDynamics
2797
Netherlands BV
Haaksbergweg 75
1101 BR Amsterdam
16752655-21 Rev. C
The Netherlands
English - 09/2021
ECG-Based Tip Confirmation System
Owner's Manual

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Summary of Contents for AngioDynamics C3 WAVE SYSTEM

  • Page 1 ECG-Based Tip Confirmation System Owner’s Manual EU Authorized Representative: Manufactured for: AngioDynamics 2797 AngioDynamics, Inc. Netherlands BV 26 Forest Street Haaksbergweg 75 Marlborough, MA 01752 USA 1101 BR Amsterdam 16752655-21 Rev. C USA Customer Service 800-772-6446 The Netherlands English - 09/2021...
  • Page 2 The C3 Wave System is to be used with an iPad.

  • Page 3: Table Of Contents

    Apple® are registered trademarks of Apple Inc. The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks is under license. AngioDynamic and the AngioDynamics logo are trademarks and/ or registered trademarks of AngioDynamics, Inc.
  • Page 4 TABLE OF CONTENTS 7.21 Power Off ..............27 13. MAINTENANCE and SERVICE REQUIREMENTS....50 7.21.1 iPad ............27 13.1 Routine Maintenance..........50 7.21.2 Hub ............. 27 13.1.1 ..............50 7.22 Clean-up ..............27 13.1.2 ..............50 7.22.1 Disposables ..........27 13.1.3 ..............

  • Page 5: Symbol Table

    Before starting a new procedure, verify the C3 Wave System application does not require updating. Do this by launching the App Store and selecting the Updates tab. If a C3 Wave System update is required, the user must fully understand the updates prior to starting a new procedure. The What’s New section details the revisions to the application.

  • Page 6: Introduction

    P-Wave in the ECG waveform shows substantial changes. This system is designed to aid the visualization of changes in P-Wave amplitude. The C3 Wave System has a 98% proven success rate when all of the Bundle Protocol Parameters are met.

  • Page 7: Intended Use

    5. FEATURES and CONTROLS The C3 Wave System is composed of a Hub, Power Supply, Charging Base, Remote, a disposable ECG Clip Cable and ECG Snap Lead Set. The C3 Wave System is to be used with an iPad.

  • Page 8: Ipad

    ECG-Based PICC Tip Confirmation System iPad The iPad receives the patient information wirelessly transmitted from the Hub. The interactive application displays the information guiding the user during PICC placement. The application also allows the user to save information pertaining to the procedure to the patient’s file. The iPad can be operated in a non-sterile environment using the touch screen or during a sterile procedure by placing the remote inside the sterile bag.

  • Page 9: Hub

    Owner’s Manual 5.2. The Hub allows the user to set up a standard three-lead ECG connection to the patient prior to the start of the PICC location procedure. During the PICC location procedure two leads [Red and Black] from this Hub are used together with the ECG clip [White] lead on the stylet wire to create the guidance ECG wave form.

  • Page 10: Hub Power Sources

    ECG-Based PICC Tip Confirmation System Battery Indicator LED Battery test: Press the Power Button for less than one second to illuminate Hub battery indicator LED. Red flash indicates charging is required. Yellow flash indicates partially charged. Green flash indicates the Hub is charged 90% or more. Run time with full charge is approximately eleven hours.

  • Page 11: Charging Base

    Owner’s Manual 5.3.2 Charging Base When not in use the Hub can be charged while resting in the Charging Base. Plug the medical grade power supply [5VDC, 10W] into the Charging Base and verify the Hub Battery Indicator LED is flashing. 16752655-21 Rev C - English...

  • Page 12: Remote

    ECG-Based PICC Tip Confirmation System 5.4. Remote The Remote provides a wireless connection between user and iPad. The remote is non-sterile and requires the use of the provided bag to create the sterile field. Enter Button Arrow Buttons (Up/Down, Left/Right Battery Power On Press any button to turn Remote ON.

  • Page 13: Ecg Clip Cable

    Warning Never use a visibly damaged external Power Supply. Return to Angiodynamics for Service. Warning To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

  • Page 14: Technical Specifications

    Use only the IEC approved batteries provided with C3 Wave System. Use of unapproved batteries may compromise patient/user safety or damage unit. Warning Use of cables or accessories, other than those packaged with C3 Wave System, may negatively affect EMC performance. 6. TECHNICAL SPECIFICATIONS iPad See iPad owner’s manual for technical specifications.

  • Page 15: Remote

    AES128ECB Summary of Wireless Interfaces The C3 Wave system uses two wireless communications protocols: IEEE 802.11 WiFi over 2.4GHz or 5GHz and Bluetooth 4.0 + LE. Optionally a cellular connection on appropriately equipped versions of the iPad can be used for certain functions (see below). The Wi-Fi and cellular interfaces are not used to control the function of the C3 Wave device in any way.
  • Page 16 The Hub and remote use the Bluetooth connection. An AES128 ECB encryption protocol is used to encrypt the Hub data. No encryption is used on the remote. Note: The C3 Wave System Hub and remote can only be connected to one iPad at a time.

  • Page 17: Application And Ipad Operation

    C3 App Icon Turn on iPad using Sleep/Wake button. 7.2 Launch Application Sleep/Wake Using the touch screen, tap the C3 Wave System Button application to open. New Procedure Using the touch screen, tap “New Procedure” to begin. 16752655-21 Rev C - English...

  • Page 18: Enter Patient Id/Note

    ECG-Based PICC Tip Confirmation System 7.4 Enter Patient ID/Note Use touch keypad to enter patient ID. If Notes are required enter them now. When finished, tap Begin Procedure. Tap the Back button located at the top left corner of the screen at any time to return to the previous screen. Power On Hub Press and hold the Power Button for two seconds.

  • Page 19: Connect 3 Patient Snap Leads

    Owner’s Manual 7.6 Connect 3 Patient Snap Leads Connect the ECG Snap Leads to the corresponding color of the Hub. Snap the disposable ECG Adhesive Electrodes from the kit to the ECG snap leads. 16752655-21 Rev C - English...

  • Page 20: Apply The Ecg Adhesive Electrodes To Patient's Chest

    Clean the patient’s skin. Remove the ECG Adhesive Electrodes clear backing and apply to patient’s skin. Note: Avoid areas with excessive hair. Follow color codes/lettering on Hub: RA (White) = Right Arm, LA (Black) = Left Arm, LL (Red) = Left Leg. Note: For international use the ECG Snap Lead connections are: R (Red) = Right Arm, L (Yellow) = Left Arm, F (Green) = Left Leg. Note: It is recommended that the Angiodynamics supplied ECG pads be used. 16752655-21 Rev C - English...

  • Page 21: Verify Surface Ecg Signal

    Owner’s Manual 7.8 Verify Surface ECG Signal Verify patient’s ECG waveform is acceptable for use in guiding PICC location. Note: Patient and PICC must be still while reading wave forms Note: If lead is incorrectly positioned or not connected the Lead OFF alert will appear. 7.9 Collect a Baseline ECG Snapshot During Surface Mode Use Remote to highlight Camera icon. Press Enter to select image. If using touch screen tap Camera icon to select image.

  • Page 22: Enter Surface Measurement

    ECG-Based PICC Tip Confirmation System 7.9.1 If image is correct use Remote to highlight Accept icon. Press Enter to save image. If using touch screen tap Accept icon to save image. 7.9.2 If image is incorrect use Remote to highlight Refresh icon. Press Enter to generate new image.

  • Page 23: Enter Internal Mode

    Owner’s Manual 7.11 Enter Internal Mode Use the Remote to highlight the Surface icon. Press the Enter button to slide the Surface icon to the Internal icon. If using the touch screen tap the Internal icon. Note: Verify the ECG trace changes from yellow with yellow scroll bar to a blank trace with a blue scroll bar. The PICC OFF alert will also appear on the screen. A white trace will resume when the ECG Clip Cable is connected. 7.12 Prep Sterile Field 7.12.1 Remote Place Remote in sterile bag.

  • Page 24: Connect Ecg Clip Cable To Picc

    ECG-Based PICC Tip Confirmation System 7.14 Connect ECG Clip Cable to PICC Squeeze alligator clip and place on the metal portion of stylet wire. When alligator clip connection is made a PICC OFF alert will appear. This warning will be cleared in Section 7.15. Note: C3 Wave System only works with conductive [metal] stylets.

  • Page 25: Collect Ecg Snapshot Of Deflection And Maximum P-Wave

    Owner’s Manual 7.16 Collect ECG Snapshot of Deflection and Maximum P-Wave Use Remote to highlight Camera icon. Press Enter to select image. Note: See IFU for more information on Deflection and Maximum P-Wave. 7.16.1 If image is incorrect use remote to highlight Refresh icon. Press Enter to generate new image. 7.16.2 If image is correct use Remote to highlight Accept icon. Press Enter to save image.

  • Page 26: Enter Implant Depth

    ECG-Based PICC Tip Confirmation System 7.17 Enter Implant Depth When a Snapshot is accepted the Internal Measurement screen will pop-up. Use Remote to scroll to correct measurement. The current selection will be highlighted in the blue box. Press enter to Accept measurement. 7.18 Finish Procedure When the last Snapshot is saved use the Remote to highlight Finish.

  • Page 27: Bundle Protocol Parameters

    Owner’s Manual 7.19 Bundle Protocol Parameters Read the bundle protocol questions to verify all parameters have been met. If you can answer Yes to all questions tap Yes and then tap OK. If you cannot answer Yes to all questions tap No then tap OK. After OK is selected the Patient File Screen will pop up.

  • Page 28: Save, Print Or Replay Patient Files

    Model: QL-720NW 1. Exit the C3 Wave System App by pressing the home button and open the iPad settings app 2. Make sure that the printer is on and that the “Wi-Fi” LED is illuminated (press and hold down the button below “Wi-Fi”...
  • Page 29 11. Note the SSID and password Connect to the Printer 1. Exit the C3 Wave System App by pressing the home button and open the iPad settings app 2. Make sure the printer is on 3. Select “Wi-Fi” and enter the SSID of the printer 4.
  • Page 30 ECG-Based PICC Tip Confirmation System Note: For both printers when the printer is disconnected or turned off, you may have to go back into the Settings App. Select “WiFi” and make sure you are connected; then find the printer and tap it (It will have a blue check next to it when selected). Warning Issue Screenshot No paper Printer out of paper Insufficient battery level Failed to retrieve printer status Overheating error Paper jam Replace paper cassette while printing Feeding error or end of paper Please load the label roll (DK-2205) No label roll inserted Cover open...

  • Page 31: Print

    Owner’s Manual 7.20.3 Print Use the touch screen to highlight the Patient File you wish to print. On the right hand side of the screen the patient information preview will be displayed. The ECG snapshots will be checked which indicates they will be printed. If one or more snapshots are not required, deselect them by tapping on the snapshot to remove the check mark.

  • Page 32: Reusables

    ECG-Based PICC Tip Confirmation System 7.22.2 Reusables The iPad, Remote, Hub and ECG Leads should be cleaned when the procedure is completed. 8. ADDITIONAL APPLICATION CONTROLS ECG Wave Zoom When the patient’s ECG wave is difficult to read or when more detail is preferred, use the [zoom] icon to change the size of the ECG trace.

  • Page 33: Scroll Through Snapshots

    Owner’s Manual Scroll Through Snapshots Four Snapshots can be displayed at any one time. When five or more Snapshots have been selected the user will need to scroll to view them. Using the remote’s Up button, highlight the Snapshots. Once highlighted, the left and right buttons allow the user to scroll through the images.

  • Page 34: Delete Patient Files

    ECG-Based PICC Tip Confirmation System 8.3 Delete Patient Files To delete a Patient file, tap the File Manager icon on the home screen. A list of Patient Files will appear on the left hand side of the screen. Scroll through the list by dragging up or down . Tap the file you wish to delete. The contents of the file will be displayed on the right hand side of the screen.

  • Page 35: Account Settings/Registration

    Owner’s Manual 8.4.1. Account Settings/Registration The account settings are configured by Angiodynamics. Changing the account settings without fully understanding the effects of those changes is not recommended. The App is registered by Angiodynamics for the end user. 8.4.2. Hub Serial Number The serial number of the currently paired Hub.

  • Page 36: Emr Url

    ECG-Based PICC Tip Confirmation System Remote: If it becomes necessary to pair a remote with a different iPad follow these steps: 8.4.4.6. Press and hold all four arrow buttons for about 10 seconds. This will remove all pairing information from the remote. Remove the hold. If the buttons flash twice and then turn off it was successful. 8.4.4.7. On the new iPad go to settings & support and press the “Pair” icon under Remote Serial # 8.4.4.8. On the remote press any button and the blue remote LEDs will begin to flash slowly. 8.4.4.9. On the iPad press the area marked “Remote”. This will pair the remote with the iPad. 8.4.4.10. You can verify that the Hub has paired correctly by checking that the serial numbers match. 8.4.5. EMR URL Enter the URL for your facility’s EMR. When the launch EMR icon is entered in the File Manager Screen, the App will automatically connect and allow you to transfer patient files.

  • Page 37: Turn Passcode On

    Owner’s Manual 8.4.6. Turn Passcode On Use this as an additional security measure. When turned On, the App will require the use of a passcode to start a new procedure or view patient files. 8.4.7. Set Passcode Use this function to change the passcode at regular intervals as an additional security measure. 8.4.8.

  • Page 38: Cleaning

    ECG-Based PICC Tip Confirmation System 9. CLEANING The Hub, Remote, and associated cables [excluding disposables] may be cleaned using a soft cloth or wipe in combination with the following using your institution’s guidelines or disinfectant manufacturer’s recommendations. Prior to cleaning, disconnect all power sources and turn OFF power. (Reference iPad user manual for cleaning instructions).

  • Page 39: Parts And Accessories

    Owner’s Manual 10. PARTS and ACCESSORIES 10.1. Parts Description Hub Battery, 1.2V, 800mAh, NiMh Remote Remote Battery, 3V, 230mAh, LiMn ECG Accessory Pack [ECG Clip Cable & Bag; 25-box] ECG Snap Leads Set Power Cord 10.2 Accessories Brother Label Printer QL-720NW Brother Label Printer QL-820NWB [Office use only, NOT for patient bedside use.] 16752655-21 Rev C - English...

  • Page 40: Troubleshooting Guide

    ECG-Based PICC Tip Confirmation System 11. TROUBLESHOOTING GUIDE 11.1. Alarms, Alerts & Informational Messages Warning Condition Persistence Screenshot PICC Lead Off PICC lead disconnected from the Skippable - cleared by pressing patient. App in "internal mode". "Dismiss" ECG Lead Off ECG lead disconnected from the Skippable - cleared by pressing patient.
  • Page 41 Owner’s Manual Warning Condition Persistence Screenshot 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 Unskippable - cleared by is lost reconnecting the Hub Hub Low Battery Hub battery is below 50% Skippable - cleared by pressing "Dismiss"...
  • Page 42 ECG-Based PICC Tip Confirmation System Warning Condition Persistence Screenshot Remote Low Battery Remote battery level is below 50% Skippable - cleared by pressing "Dismiss" Remote Critical Remote battery level is below 20% Skippable - cleared by pressing Battery "Dismiss" Hub Charging Hub is charging via charging base Unskippable - cleared by or power supply...
  • Page 43 Hub will not charge – Batteries over-discharged If the LED shows solid red when charging replace solid red charge LED the batteries No batteries present Verify that Angiodynamics approved medical grade batteries have been installed 16752655-21 Rev C - English...
  • Page 44 ECG-Based PICC Tip Confirmation System Remote will not Batteries drained Replace batteries power on Remote powers on Remote not paired See Section 8.4.4 “Pairing & Un-Pairing Devices” for but will not connect instructions. (continuous flashing) 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...
  • Page 45 Owner’s Manual No PICC signal (with ECG lead disconnected Check that each ECG lead is connected to the Hub a warning message and to an ECG pad E202) 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...
  • Page 46 ECG-Based PICC Tip Confirmation System Unable to print 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...
  • Page 47 (E206) displayed Batteries inserted incorrectly Make sure that the batteries are correctly inserted Wrong batteries being used Make sure that only Angiodynamics approved medical grade batteries are being used Internal system error Problem or interference with internal Turn the Hub off and back on again...

  • Page 48: Standards, Declarations And Licensing

    ECG-Based PICC Tip Confirmation System 12. STANDARDS, DECLARATIONS AND LICENSING 12.1 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.
  • Page 49 Table 1 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The C3 Wave System is intended for use in the electromagnetic environment specified below. The customer or the user of the C3 Wave System should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment – Guidance...
  • Page 50 ECG-Based PICC Tip Confirmation System Table 2 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity C3 Wave System is intended for use in the electromagnetic environment specified below. The customer or the user of the Wave System should assure that it is used in such an environment.
  • Page 51 Owner’s Manual Table 3 Guidance and manufacturer’s Declaration – Electromagnetic Immunity C3 Wave System is intended for use in the electromagnetic environment specified below. The customer or the user of the Wave System should assure that it is used in such an environment. IMMUNITY TEST IEC 60601 TEST LEVEL Compliance Level Electromagnetic Environment – Guidance...
  • Page 52 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the C3 Wave System is used exceeds the applicable RF compliance level above, the C3 Wave System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the C3 Wave System.
  • Page 53 RF communications equipment and the C3 Wave System The C3 Wave System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the C3 Wave System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the C3 Wave System as recommended below, according to the maximum output power of the communications equipment.

  • Page 54: Maintenance And Service Requirements

    ISO/IEC 18000-4 Mode 1 (2.45 GHz) 54 V/m The C3 Wave System was tested to the RFID test protocols listed above. The testing was performed to test methods that were developed by AIM Global, FDA, and MET Laboratories. 13. MAINTENANCE and SERVICE REQUIREMENTS 13.1 Routine Maintenance...

  • Page 55: Semi-Annual Maintenance

    AngioDynamics, Inc hardwareservices@angiodynamics.com +1 866-883-8820 When calling please have the following information available: Model of unit, serial number, date of purchase, and description of problem. 13.5 Training Contact your local AngioDynamics sales representative to schedule training. 16752655-21 Rev C - English...

  • Page 56: Returning Unit For Repair

    ECG-Based PICC Tip Confirmation System 13.6 Returning Unit for Repair If it becomes necessary to return C3 Wave System for repair, contact the Technical Service Department. You will be issued a Return Authorization [RA] number. Clean and decontaminate the components prior to returning for repair. Package the components in a manner equivalent to the way they were purchased.

  • Page 57: Limited Warranty

    AngioDynamics, unless authorized by AngioDynamics. AngioDynamics shall have no obligation to make repairs, replacements, or corrections which result, in whole or in part, from normal wear and tear. AngioDynamics makes no warranty (a) with respect to any products that are not Products; (b) with respect to any products purchased from a person other than AngioDynamics or an AngioDynamics-authorized distributor;...

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