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Gaumard NOELLE S554.100 User Manual

Maternal birthing simulator
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NOE LLE®S554.100
Matern al B ir t h in g Si mul ato r
User Guide
User Guide 22.5.1
NOELLE is an interactive educational system developed to assist a certified
©2022 Gaumard Scientific
instructor. It is not a substitute for a comprehensive understanding of
All Rights Reserved
the subject matter and not intended for clinical decision making.
www.gaumard.com

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Summary of Contents for Gaumard NOELLE S554.100

  • Page 1 User Guide User Guide 22.5.1 NOELLE is an interactive educational system developed to assist a certified ©2022 Gaumard Scientific instructor. It is not a substitute for a comprehensive understanding of All Rights Reserved the subject matter and not intended for clinical decision making.

  • Page 3: Table Of Contents

    NOELLE® S554.100 | User Manual Contents End User License Agreement viii 1. Introduction 1.1 Specifications NOELLE Newborn 1.2 Care and Maintenance General IV Arm Operating Conditions Storage Conditions Procedures Cleaning Birth Canal Maintenance Post-Partum Hemorrhage Check List and Warnings Labor 2.
  • Page 4 4.4 Status/Details Controls Changing Vital Signs Applying Changes Creating Palette Items 4.5 Model (Newborn) Physiological Modeling State Cyanosis Levels 5. Working with NOELLE 5.1 Cephalic Seizures 5.2 Airway Nasal and Oral Intubation 5.3 Artificial Respirations Ventilation Calibration iv | NOELLE S554.100...
  • Page 5 NOELLE® S554.100 | User Manual 5.4 Circulation Compression Calibration Bilateral Pulses Injection Site Bilateral IV Arm Instructions for Use 5.5 Obstetrics Normal Labor and Delivery Placenta Delivery Vacuum-Assisted Delivery Leopold Maneuver Optional Leopold Maneuvers Dilating Cervix Shoulder Dystocia Cesarean Delivery Optional Cesarean Delivery Prolapse of the Umbilical Cord Placenta Previa...
  • Page 6 NOELLE S554.100 | User Manual 7. Other 7.1 Selected Parts List 7.2 Replacing the Veins Replacement Instructions 7.3 Troubleshooting 8. Wireless Network 8.1 For Windows 8 and 10 Configure the Vital Signs Broadcast 9. Warranty 9.1 Exclusive One-Year Limited Warranty 63 9.2 Extended Warranty...

  • Page 7: End User License Agreement

    Gaumard. By installing the UNI™ (the “software”) media, you agree to be bound by the terms of this agreement. If you d o not agree to the terms of this agreement, promptly return the uninstalled med ia and accompanying items to Gaumard at the ad d ress indicated below.

  • Page 8: Introduction

    › NOELLE: 54 lbs (24.5 kg) with abdominal cover · Length: 5’8” inches (172 cm) · Wired connectivity: Gaumard USB Communication Module (RJ45) · Battery Charger: › Power input: 100-240 VAC, 50/60 Hz, 500 ma/ 50 VA › Power output: 12 VDC/ 2 A/ 24VA ·...

  • Page 9: Care And Maintenance

    General · Ball point pens, ink, and markers permanently stain the skin. · Do not wrap this or any other Gaumard product in newsprint. · Marks made with ballpoint pens, ink or marker cannot be removed. · Replacement parts are available from Gaumard Scientific or from your...

  • Page 10: Operating Conditions

    NOELLE S554.100 | User Manual Operating Conditions   · The simulator will only power on when connected to the AC power supply.   · Operating temperature: 50°-95° F (10°-35° C)   · Humidity: 5%-95% (non-condensing) WARNING: To avoid damage to the simulator, please store and ship it in the clear poly bag provided.

  • Page 11: Birth Canal Maintenance

    Birth Canal Maintenance · Ball point pens, ink and markers permanently stain the birth canal insert. · Do not wrap this or any other Gaumard product in newsprint. · The birth canal insert can be cleaned with a small amount of silicone lubricant.

  • Page 12: Getting Started

    NOELLE S554.100 | User Manual 2. Getting Started 2.1 Overview The NOELLE S554.100 is a comprehensive package of simulator technol- ogy, scenario-based training, and performance measurement and debrief- ing tools designed to build competencies needed to help manage OB emergencies.

  • Page 13: Simulated Vital Signs Monitor

    Select up to 5 dynamic waveforms including ECG II, ABP, respiration, CO2, and pulse oximetry • Fetal Heart Rate monitor 2.2 Terminology The Gaumard User Interface software application, used to control the simulator and evaluate care providers. Facilitator The person conducting the simulation; an instructor or lab staff member. Provider A person participating in the simulation as a healthcare provider.

  • Page 14: Scenario

    NOELLE S554.100 | User Manual Scenario A saved sequence of physiological states, which flow like a “play list.” Scenarios provide a level of automation that unburdens the facilitator and allows standardized presentation of symptoms. Scenario Item A Palette Item that is part of a scenario. Scenario Items may also repre- sent a fixed delay period (“Wait”) or a pause (“Wait Indefinitely”).

  • Page 15: Equipment Setup

    NOELLE S554.100 | User Manual 3. Equipment Setup 3.1 Overview NOELLE is shipped partially assembled. The birthing fetus and neonate are fully assembled. Perform the following steps as part of the first install process. Leg Assembly Remove the fixed bolts from the knee joints using the hex- agonal wrench provided.

  • Page 16: Newborn Power Supply

    3.2 Control Computer The laptop computer is the simu- lator’s control center. Startup and control commands are sent from the Gaumard control software (UNI) to the simulator using the wired communication module shown in the next section. Review all manufacturer warnings and procedural information included with the laptop’s documentation before continuing.

  • Page 17: Virtual Monitor

    The wireless connection allows the UNI con- trol software to send vital signs infor- mation to the Gaumard Monitors soft- ware. To verify the wireless connection, click on the wireless icon located on the task tray. To troubleshoot connection issues, please refer to section 10.

  • Page 18: Gaumard Monitors

    NOELLE S554.100 | User Manual Gaumard Monitors After the wireless connection is estab- lished, double click or tap the Gaumard Monitors icon on the virtual monitor’s home screen. The Gaumard Monitors software is now ready to receive vital signs information generated by the UNI control software.
  • Page 19 NOELLE S554.100 | User Manual Initializing the Simulator with UNI & OMNI Link Noelle also has the capability to connect to its USB tablet/PC via a Bluetooth connection provided by an OMNI Link Wireless Adapter Kit. It is strongly recommended to connect to the simulator using the OMNI Link for optimal audio quality when using the simulator's streaming audio features.
  • Page 20 NOELLE S554.100 | User Manual Turning on the Simulator with OMNI Link 1. Disconnect the RF module from the UNI tablet/PC. 2. Double click the UNI icon and select the correct simulator profile. Ensure you are using UNI version 2.46.2 or newer.
  • Page 21 NOELLE S554.100 | User Manual NOTE: After the initial OMNI Link setup, the subsequent warning message will change to one that will detect an available Bluetooth connection in the absence of an RF module and ask you if you would like to attempt Bluetooth connection.
  • Page 22 NOELLE S554.100 | User Manual 6. The "Bluetooth Information" message will appear. Allow the simulator to connect. NOTE: The OMNI Link has to be flashing green for the simulator to connect. If the OMNI Link is purchased separately from the simulator, the OMNI Link and UNI Tablet/PC will need to be paired beforehand.

  • Page 23: Working With Uni

    NOELLE S554.100 | User Manual 4. Working with UNI 4.1 Initializing the Simulator Read the manufacturer’s care and caution information. Press the power button to turn on the PC. The UNI software initializes the simulator. Double click the UNI icon on the tablet’s home screen to...

  • Page 24: Uni Interface

    4.2 UNI Interface The UNI components and programming procedures are consistent throughout the Gaumard family of high fidelity simulators. Some software controls and features covered in this guide may be hidden depending on the simulator’s hardware configuration and optional upgrades.

  • Page 25: Power/Stand By

    NOELLE S554.100 | User Manual Power/Stand By The power button is located at the bottom right corner of the UNI software. Toggle the power button to set the simulator to stand-by mode and then again to resume. 4.3 Quick Launch The UNI interface opens up showing the quick launch page for the scenarios.

  • Page 26: Selecting The Scenario

    NOELLE S554.100 | User Manual Notice that one or more scenario types can be selected at the same time and the list of scenarios on the right will display only the scenarios included in the selected categories. Selecting the Scenario Click on one of the scenarios listed to highlight it and the scenario can either, be started immediately or loaded.
  • Page 27 NOELLE S554.100 | User Manual Click on the drop down arrow to the right to read a scenario description. Clicking “Start Scenario” loads the appropriate scenario and starts it playing without the user having to do anything else with the control computer.

  • Page 28: Favorites

    NOELLE S554.100 | User Manual Favorites The “Favorites” feature allows users to reduce the number of scenarios highlighted to those within the categories that will be used most fre- quently. Enable the “Favorites” feature by clicking the star icon. Then select the categories or scenario types to be stored under this feature.

  • Page 29: Changing Vital Signs

    NOELLE S554.100 | User Manual Separate the features by region by clicking one of the icons on left. Changing Vital Signs To adjust numerical values click the slider control. (e.g. heart rate, blood pressure, respiratory rate, etc.). Alternatively, use the key-...

  • Page 30: Applying Changes

    NOELLE S554.100 | User Manual Applying Changes No changes will be made to the simulator’s condition until the new settings are submitted using the “Apply” panel. After the list of changes is created, click “NOW” to up- date the vital signs instantly.

  • Page 31: Creating Palette Items

    NOELLE S554.100 | User Manual Enable the “instant apply” option and click the control to change the vital sign to a new value without the need to use “Apply” panel. Vital signs undergoing change blink yellow. Creating Palette Items A palette item stores one or more vital sign settings into a single loadable object.
  • Page 32 NOELLE S554.100 | User Manual Select the palette item from the “Load Palette Item” menu and click “Load”. Click the apply option to sub- mit the changes. Working with UNI | 21...

  • Page 33: Model (Newborn)

    NOELLE S554.100 | User Manual 4.5 Model (Newborn) The physiologic cyanosis model adjusts vital signs and skin color in response to ventilation effectiveness. Set the physiological modeling state to deteriorate and monitor the provider’s intervention effectiveness using the CPR monitor window. The model speed can be controlled through the Model warp-factor, which goes from 1 to 5 (1 representing real-time).
  • Page 34 NOELLE S554.100 | User Manual Severe Cyanosis: Neonate is blue, apneic and vital signs are rapidly wors- ening. Improve Gain: Adjust the slider to increase or decrease the cyanotic response to ventilations. Oxygen: By adjusting the oxygen rate, the baby will improve faster with proper ventilation.

  • Page 35: Working With Noelle

    NOELLE S554.100 | User Manual 5. Working with NOELLE 5.1 Cephalic Seizures The simulator is capable of convulsing to simulate mild or severe seizures. Use the software controls to enable the seizure behavior. 5.2 Airway Nasal and Oral Intubation Airway management techniques...

  • Page 36: Artificial Respirations

    NOELLE S554.100 | User Manual 5.3 Artificial Respirations Software controlled breathing patterns: Kussmaul’s, Cheyne- Stokes, Biot’s, Apneustic, apnea, and normal. Ventilation Use a normal size adult BVM which will seal around the mouth and nose. The ribs have normal anatomic landmarks and the lungs expand normally permitting realistic chest rise.
  • Page 37 NOELLE S554.100 | User Manual Click Setup > Calibra- tion > Ventilations, and click “Next” The wizard prompts to perform ventilation #1 Perform the first ventila- tion. A green filled oval in- dicates that the ventilation was recorded successfully Perform ventilation #2 as prompted by the wizard.

  • Page 38: Circulation

    NOELLE S554.100 | User Manual 5.4 Circulation Compression Chest compressions are mea- sured and logged, showing the instructor exactly how facilitators are performing. Calibration The compressions sensor is factory calibrated prior to shipment. To customize the parameters for chest compressions please follow the procedure outlined in the compression calibration procedure.

  • Page 39: Bilateral Pulses

    NOELLE S554.100 | User Manual After clicking “Start”, the wizard prompts to perform compression “#1” Perform the first compression. A green filled oval indicates that the compression was recorded successfully. Perform compression # 2 as prompted by the wizard. A green filled oval indicates that the compression was recorded successfully.

  • Page 40: Bilateral Iv Arm

    Always leave the drain port connected when injecting fluids into the system. Use only Gaumard’s simulated blood. Any other simulated blood brand containing sugar or any additive may cause blockage and/or interruption of the vasculature. Always flush the IV system with distilled water at the end of every simulation.

  • Page 41: Obstetrics

    NOELLE S554.100 | User Manual Connect the syringe with tubing to one port and the drain tube with clamp to the other port as shown. Leave the drain tube clamp opened and depress the syringe until all air has been pushed from the IV system and fluid runs from the drain.
  • Page 42 NOELLE S554.100 | User Manual Lubricate the vulva and cer- vix internally and externally using silicone lubricant. Attach the umbilical cord to the baby. WARNING: Route the cord so that it does not bind in the mechanism. The umbilical cord can be wrapped around the fetal neck or coiled out of the way.
  • Page 43 NOELLE S554.100 | User Manual Note that the fetus has 2 receptacles at the perineum into which the matching pins located on the birthing mechanism are inserted. Attach the fetus to the birthing mechanism. 10. Once the baby is connected...
  • Page 44 NOELLE S554.100 | User Manual Left Occiput Anterior (LOA) Left Occiput Posterior (LOP) 12. Put the abdominal cover in place. WARNING: Do not operate the birthing mechanism without the ab- dominal cover in place. To load a labor scenario: Go to the labor tab and click “Load”.
  • Page 45 NOELLE S554.100 | User Manual The labor is now loaded. Increase the labor speed to complete the simulated labor in a fraction of the time. Click “Play” to start the labor scenario. The green vertical bar on the labor graph moves to the right indicating the labor progress.
  • Page 46 NOELLE S554.100 | User Manual The cervix dilates as the fetal head moves down the birth canal. Crowning of the fetal head can be seen. External fetal rotation aligns shoulders with the longitudinal axis of the vulva. The fetus is released from...

  • Page 47: Placenta Delivery

    NOELLE S554.100 | User Manual WARNING: Avoid lifting or pulling the fetus upward while it is still engaged to the birthing arm. Doing so could make delivering the fetus difficult even if the fetus latching mechanism is unlocked. Deliver the fetus.
  • Page 48 NOELLE S554.100 | User Manual In addition, note that the placenta is designed with two removable placental fragments. These fragments are attached to the body of the placenta with Velcro. You may reverse one or both fragments causing one or both to birth with the placenta or remain affixed to the uterine wall.

  • Page 49: Vacuum-Assisted Delivery

    NOELLE S554.100 | User Manual Vacuum-Assisted Delivery Vacuum-assisted delivery may be practiced with the NOELLE simulator using a vacuum cup. Begin the vacuum-assisted delivery by inserting the soft scalp over the skull of the birthing fetus. Placing the soft scalp over the skull improves the vacuum seal between the fetal head and the vacuum.

  • Page 50: Leopold Maneuver

    NOELLE S554.100 | User Manual Leopold Maneuver Practice Leopold Maneuvers with NOELLE. Retract the birthing mechanism and remove the articulating birthing baby. Place elevating pillow within simulator. Route the inflation bulb outside NOELLE through any space provided on the left side.

  • Page 51: Optional Leopold Maneuvers

    NOELLE S554.100 | User Manual Optional Leopold Maneuvers NOELLE has an optional silicone Leopold Maneuver abdominal cover. The fetus floats freely inside an amniotic sack which provides tactile feedback and resistance when performing the Leopold Maneuvers or external version exercise.

  • Page 52: Shoulder Dystocia

    NOELLE S554.100 | User Manual Shoulder Dystocia Noelle may be used to practice the resolution of dystocia using episioto- my techniques, the McRobert’s maneuver, suprapubic pressure, posterior arm sweep, or elbow-knee delivery. To demonstrate shoulder dystocia, place the fetal baby in the ROA position.

  • Page 53: Cesarean Delivery

    NOELLE S554.100 | User Manual Perform the dystocia management techniques. The fetus is not unlocked from the birthing arm automatically at the end of the scenario while the dystocia feature is enabled. Once the maneuvers are performed properly, click the “Release”...

  • Page 54: Optional Cesarean Delivery

    NOELLE S554.100 | User Manual Optional Cesarean Delivery The optional c-section abdominal cover can also be used. Lubricate the top of the insert before making the incision. Prolapse of the Umbilical Cord Simulate prolapse of the umbilical cord by positioning cord on a critical position and decreasing the fetal heart rate from the UNI status and details tabs.

  • Page 55: Breech Birth

    NOELLE S554.100 | User Manual Breech Birth To simulate breech presentations with the Noelle: Fully retract the birthing mechanism. Remove the fontanelle plug from the fetus. The fetus has a receptacle at the rectum and frontal fontanelle location into which...

  • Page 56: Postpartum Activity

    PPH reservoir 900 mL To fill the internal hemorrhage reservoir with simulated blood: In a separate container, mix a solution of Gaumard simulated blood colorant and water. Fill the kit syringe with the simulated blood solution. Connect the kit syringe to...

  • Page 57: Fundal Massage And Postpartum Hemorrhage

    NOELLE S554.100 | User Manual Fundal Massage and Postpartum Hemorrhage To setup NOELLE for uterine bleeding and a fundal massage exercises: Set the uterine pressure to 1% and the contrac- tion intensity to zero. WARNING: Do not install the uterine insert before adjusting uterine pressure and contrac- tion intensity.

  • Page 58: Cleaning The Pph System

    NOELLE S554.100 | User Manual Install the elevating pillow underneath the uterus. Pump the pressure bulb on the elevating pillow to adjust the height of the uterus if needed. Attach the abdominal cover to NOELLE’s torso. Set the Uterine hemor- rhage control to “ON””...

  • Page 59: Episiotomy Repair

    NOELLE S554.100 | User Manual Turn on the PPH features to flush the any simulated blood left in the reservoir. Allow the PPH feature to run until all the clean water exits the system. Episiotomy Repair Remove the fully dilated vulva used during delivery and select one of the two episiotomy repair modules.
  • Page 60 NOELLE S554.100 | User Manual Secure the insert to the hook and loop fasteners around the circumference of the pelvis. “000” sized sutures are recommended to extend the life of the repair modules. Working with NOELLE | 49...

  • Page 61: Working With Newborn

    NOELLE S554.100 | User Manual 6. Working with Newborn 6.1 Airway Newborn’s airway can be intubated intubated orally using LMA or endotracheal tubes and nasally using a nasogastric tube. Procedure Device Size Intubation (Blade size) Miller 0 Size 1 Nasal Intubation...

  • Page 62: Cardiac

    NOELLE S554.100 | User Manual 6.3 Cardiac Newborn is equipped with sev- eral realistic heart sounds which tied to heart rates and select- able rhythms. 6.4 Circulation Newborn’s software controlled umbilical pulse is blood pressure and heart rate dependent. To install or the umbilical cord, first turn the simulator off (by clicking on File, Exit on the UNI software), or set the manikin on STAND-BY mode.

  • Page 63: Systemic

    NOELLE S554.100 | User Manual 6.6 Systemic Intramuscular Injection sites are located on both deltoids and quadriceps for placement and technique exercises. 6.7 Other Vital Signs Monitor The Virtual Signs Monitor simulates a vital signs monitor attached to Newborn. The vital signs are synchronized through a wireless network between the facilitator’s tablet and the computer running the monitor.

  • Page 64: Other

    NOELLE S554.100 | User Manual 7. Other 7.1 Selected Parts List Contact Gaumard Scientific for a complete list of consumables and re- placement parts and their prices. Item Type Code Birth Canal (Light, Medium, Dark) Consumable S554.100.134 Replace- PLacenta with detachable fragments S554.100.136.R2...

  • Page 65: Replacing The Veins

    NOELLE S554.100 | User Manual 7.2 Replacing the Veins To replace the veins used in the lower arms, gather the following items: • Replacement vein set • Silicone oil • Heat gun or blow dryer • Hemostat (Optional) Replacement Instructions Turn off the simulator.
  • Page 66 NOELLE S554.100 | User Manual Remove both black rings on the tubes and place them on the replacement veins. Insert the replacement veins to each white connector, and secure the veins with the black rings. To replace the dorsal vein of...
  • Page 67 NOELLE S554.100 | User Manual 12. Apply small amounts of sili- cone oil on the lower arm to aid the skin placement. 13. Place the skin over the hand. Stop half way and insert the foam covering the IV fill and drainage ports.

  • Page 68: Troubleshooting

    NOELLE S554.100 | User Manual 7.3 Troubleshooting Communication with the simulator cannot be established Battery is discharged. If NOELLE’s backup battery is completely discharged, connect the charger and wait 20 minutes to power on the simulator. Leave the simulator connected while in use.
  • Page 69 NOELLE S554.100 | User Manual Streaming audio does not work, tab is not displayed The backup battery on the Plug charger into the simulator. Verify LED light on charger indicates simulator is depleted “charging” status. • NOELLE should always be plugged in while being operated. The birth mechanism is power intensive and will drain the backup battery quickly.
  • Page 70 NOELLE S554.100 | User Manual Noelle’s delivery baby does not release at delivery end Dystocia is “ON” When “Dystocia On” button is checked, the baby is not released until check- ing “Dystocia Off”. Motor is “disoriented” Reset the delivery motor by going to the Gear> Setup> Options menu, “NO- ELLE Features”...

  • Page 71: Wireless Network 8.1 For Windows 8 And

    NOELLE S554.100 | User Manual 8. Wireless Network 8.1 For Windows 8 and 10 If you received the Gaumard Monitor computer with the router already attached, please proceed to step number 4: Add Velcro® to TPLink router and VM. Connect Router to USB pow-...

  • Page 72: Configure The Vital Signs Broadcast

    Verify that the IP Type is set to automatic. Write down the “IP Address” and “Port number”. Click “Connect” to broadcast an outgoing connection. Start the Gaumard Monitors software on the virtual monitor PC. 10. Click the “V” menu near the top left corner, and then select “Comm Setup”.
  • Page 73 NOELLE S554.100 | User Manual 12. Click “Connect” to accept the incoming connection. Wireless Network | 62...

  • Page 74: Warranty

    Gaumard product that are manufactured by third parties. For example, third-party products such as computers (desktop, laptop, tablet, or hand held ) and monitors (stand ard or touch-screen) are not covered by this limited warranty. Gaumard d oes not provid e any warranty, express or implied, with respect to any third-party products.

  • Page 75: Contact Gaumard

    NOELLE S554.100 | User Manual 10. Contact Gaumard 10.1 Contacting Technical Support Before contacting Technical Support you must: Have the simulator’s serial number 2. Have access to the simulator for possible troubleshooting as needed Technical Support: Email: support@gaumar d .com...
  • Page 76 Gaumard®, ZOE®, Michelle®, Mike®, PEDI®, Susie Simon®, Susie®, Simon® Code Blue®, SIMA Models®, SIMA GYN/AID®, Virtual Instruments®, Code- maker®, Code Blue®, NOELLE®, Simulation Made Easy™, HAL®, eCPR™, Zack™, RITA™, Chloe™, Seatbelt Susie™, Krash Kids™, Premie™, UNI™, Omni®, SmartSkin™, OMNI® 2 are trademarks of Gaumard Scientific Company.

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