S3010 Newborn HAL User Guide 16.4.1

Contents END USER LICENSE AGREEMENT ... 5 CARE AND CAUTIONS ... 7 OVERALL W ARNINGS ... 8 ELECTRICAL THERAPY ... 9 GETTING STARTED ... 10 OVERVIEW ... 11 TERMINOLOGY... 13 EQUIPMENT SET-UP... 14 NEWBORN HAL BATTERY ... 15 CONTROL TABLE PC ... 16 VIRTUAL MONITOR... 17 WORKING WITH UNI ... 19 INITIALIZING THE SIMULATOR ... 20 UNI INTERFACE ... 24 QUICK LAUNCH... 25 STATUS / DETAILS CONTROLS ... 27 MODELING (NEWBORN/PREMIE) ... 32 WORKING WITH NEWBORN HAL ... 34 AIRWAY... 36 Intubation... 36 Airway Sounds ... 36 BREATHING ... 36 Breathing Pattern ... 36 Lung Sounds ... 36 Bilateral Chest Rise ... 36 Pulmonary Ventilation ... 37 CARDIAC ... 37 Heart Sounds ... 37 Chest compressions ... 37 ECG Monitoring and Electrical Therapy ... 37 CIRCULATION ... 38 Palpable Pulses ... 38 Programmable Blood Pressure ... 38 Connecting the Modified Cuff ... 38 Intravenous Extremities ... 38 Filling the IV Vasculature ... 39 Intramuscular Injection Sites ... 41 Intraosseous Access ... 41

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CEPHALIC ... 42 Cyanosis ... 42 Muscle Tone and Seizures ... 42 SYSTEMIC ... 42 Catheterization ... 42 Umbilical Cord (System S/N B0906424 or higher) ... 42 Bowel Sounds (Systems S/N B0906424 or higher) ... 43 OTHER ... 43 Temperature Probe Placement Detection ... 43 Vital Signs Monitor ... 43 Pro + (Optional) ... 44 APPENDIX ... 45 MORE ABOUT SCENARIOS ... 46 Factory Preset Scenarios ... 46 MORE ABOUT SCENARIOS ... 59 TROUBLESHOOTING ... 62 W IRELESS NETWORK (W ITHOUT USB ROUTER) ... 68 W IRELESS NETWORK INSTRUCTIONS (W ITH USB ROUTER) ... 71 CONSUMABLES, REPLACEMENTS, AND OPTIONAL PARTS ... 73 W ARRANTY ... 75 CONTACT US... 76

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End User License Agreement This is a legal agreement between you, the end user, and Gaumard Scientific Company, Inc. (“Gaumard”). This software is protected by copyright laws and remains the sole property of Gaumard. By installing the UNI (the "Software") media, you agree to be bound by the terms of this agreement. If you do not agree to the terms of this agreement, promptly return the uninstalled media and accompanying items to Gaumard at the address indicated below. 1. Grant of License. Gaumard hereby grants to you (an individual or institution) the right to install and activate the Software on one computer for use with one Interactive patient simulator system. The software may also be installed on any number of other computers at the same institution so that students may access the learning resources. One copy of the software may be made for backup purposes. You may not network this Software, or allow multiple users unless you purchased a multi-user workstation license. Sharing this Software with other individuals or allowing other individuals to view the contents of this Software is in violation of this license. 2. Copyright. The Software is owned by Gaumard and protected by United States copyright laws and international treaty provisions. Therefore, you must treat this Software like any other copyrighted material. You may not make this Software or copies thereof available in any manner or form or use, copy or transfer the Software, in whole or in part, except as provided herein. 3. Other Restrictions. You may not rent or lease this Software to any other party. You may not alter, merge, modify, adapt, reverse engineer, decompile or disassemble the software, or disclose the contents of this Software to any other party. 4. Electronic Transmission of Software. If you received the Software by electronic transmission or by Internet delivery, by installation of the Software, you acknowledge that you have read and understand this license agreement and agree to be bound by its terms and conditions. 5. Term of Agreement. The term of this Agreement and the license granted to you pursuant hereto shall commence upon installation of this Software. This Agreement and the license granted herein may otherwise be terminated by Gaumard in the event that you are in breach of any provision of this Agreement. In the event of termination, you agree to immediately return this Software, accompanying items, and any copies thereof to Gaumard. 6. LIMITED WARRANTY (A) THE CD-ROM MEDIA (THE "MEDIA") WHICH CONTAINS THIS SOFTWARE IS WARRANTED, FOR A PERIOD OF 30 DAYS FROM THE DATE OF PURCHASE, TO BE FREE FROM DEFECTS IN MATERIAL AND WORKMANSHIP. ELECTRONIC TRANSMISSION IS WARRANTED TO BE FREE FROM DEFECTS AT THE MOMENT OF TRANSMISSION. YOUR SOLE AND EXCLUSIVE REMEDY, AND GAUMARD'S SOLE LIABILITY, IS TO REPLACE THE DEFECTIVE MEDIA OR TO REPEAT THE ELECTRONIC TRANSMISSION PROVIDED THAT YOU NOTIFY GAUMARD IN WRITING OF SUCH DEFECT OR DEFECTIVE TRANSMISSION AND RETURN THE DEFECTIVE MEDIA, IF ANY, DURING THE 30-DAY WARRANTY PERIOD. (B) EXCEPT AND TO THE EXTENT EXPRESSLY PROVIDED IN PARAGRAPH (A), THE SOFTWARE AND ACCOMPANYING WRITTEN MATERIALS ARE PROVIDED ON AN "AS IS" BASIS, WITHOUT ANY WARRANTIES OF ANY KIND, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE. NO ORAL OR WRITTEN INFORMATION OR ADVICE GIVEN BY GAUMARD, ITS DEALERS, DISTRIBUTORS, AGENTS OR EMPLOYEES SHALL CREATE A WARRANTY OR IN ANY WAY INCREASE THE SCOPE OF THIS WARRANTY, AND YOU MAY NOT RELY ON ANY SUCH INFORMATION OR ADVICE. GAUMARD DOES NOT WARRANT, GUARANTEE, OR

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Care and Cautions

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Overall Warnings Remember that damage caused by misuse is not covered by your warranty. It is critical to understand and comply with the following guidelines. Additional warnings are found throughout the documentation If the simulator will not be used for an extended period, re-charge the battery at least once every 30 days to prevent damage to the battery. Do not attempt to intubate without lubricating the airway adjunct with a mineral oil lubricant (provided). Failure to do so will make intubation very difficult and is likely to result in damage. NEVER disconnect the communications module while the UNI software is running. The software will halt, and the module may be damaged. When simulating drug administration via endotracheal tube, providers must use an empty syringe. Passing liquids into the trachea or esophagus may cause internal damage. Newborn HAL should be cleaned with a cloth dampened with diluted liquid dishwashing soap. If medical adhesives remain on the skin, clean with alcohol wipes. DO NOT USE “GOO GONE” as the citric acid in the formula will cause pitting of the various materials comprising your simulator. Ballpoint pens, ink or newsprint, and markers permanently stain the skin.

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Store Newborn HAL in a cool, dry place. Extended storage above 85 degrees Fahrenheit (29 Celsius) will cause the simulator to soften and slowly warp. It is acceptable to operate Newborn HAL at an ambient temperature of 95 degrees Fahrenheit (35 Celsius). Newborn HAL is "splash-proof" but not water-proof. Do not submerge or allow a large volume of fluid to enter the interior of the simulator. Do not expose the tablet computer to water or excessive dust unless it is protected by a rugged case (available separately). Mouth to mouth resuscitation without a barrier device is not recommended, as it will contaminate the airway. Treat Newborn HAL with the same precautions that would be used with a real patient. The use of needles larger than 22 gauge will reduce the lifetime of the lower arms' skin and veins. When the arm veins require replacement, contact Gaumard to arrange for a lower arm exchange. Refer to the Consumables and Replacement Parts section of this guide, and contact customer service for more information. Do not inject fluids into the intramuscular sites. Intramuscular sites are for placement exercises only. Do not remove or replace the umbilical cord while Newborn HAL is in operation. Doing so will cause damage to the system.

Do not pull or carry the simulator by the limbs. Handle Newborn HAL with the same care as a human patient. The lubricants and other accessories provided are for use with the accompanying patient simulator only. The lubricants and other accessories are not suitable for human use or medical treatment/diagnosis and should never be used for such purposes. WARNING: To avoid damage to the simulator, please store and ship it in the clear poly bag provided.

The Gaumard User Interface features a virtual electrical therapy function to simulate defibrillation or pacing.

Electrical Therapy One of Newborn HAL’s most exciting features is the accommodation of real monitoring and electrical therapy devices. In most cases, no special instruction is necessary to use such devices. Newborn HAL’s conductive skin sites allow the attachment of real EKG electrodes. This feature permits the user to track cardiac rhythms with their own equipment just like with a human patient. A few special concerns are described below. Newborn HAL does not accept real electrical therapy. Do not pace or defibrillate Newborn HAL with real electrical equipment.

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Getting Started

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Overview GENERAL  

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Tetherless and fully responsive even while being transported Powered from an internal rechargeable battery or wall outlet Battery capable of 300 recharges Simulator receives commands from a wireless tablet PC and operate at distances up to 300 feet Option to operate automatically using Automatic mode or manually by the Instructor Training Guide with both basic and advanced interactive scenarios Use pre-programmed scenarios, modify them or create your own quickly and easily Installation and training worldwide Simulation Made Easy TM

AIRWAY      

Calibrate head flexion to obstruct airflow and chest rise Oral and nasal intubation Use an ET tube or LMA Sensors detect depth of intubation Unilateral chest rise with right main stem intubation Multiple upper airway sounds synchronized with breathing

APPEARANCE 

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Color responds to hypoxic events and interventions (healthy, mild cyanosis, severe cyanosis) Forearms movements reveal muscle tone (active, medium, limp)

BREATHING 

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Control rate and depth of respiration and observe chest rise Ventilation is measured and logged Select independent left and right lung sounds Chest rise and lung sounds are synchronized with selectable breathing patterns Accommodates assisted ventilation, including BVM and mechanical support Unilateral chest rise

CIRCULATION 

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Conductive skin regions allow for ECG monitoring with real equipment Multiple heart rhythms, rates and complications Heart sounds include a normal heart as well as atrial and ventricular septal defects Chest compressions are measured and logged Blood pressure can be taken bilaterally using a cuff, palpation, or auscultation Blood pressure sounds audible between systolic and diastolic pressures | Newborn HAL | User Guide | 11

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Umbilical pulse and bilateral brachial pulses operate continuously Pulse strengths vary with blood pressure and pulses are synchronized with ECG.

SIMULATOR       

Physical size is 50th percentile at 40 weeks gestational age Interchangeable genitalia Internal rechargeable NiMH battery Venous access Bilateral IV training arms Patent umbilicus Intraosseous access at tibia

CONTROL   

Wireless tablet PC with stylus control Communication modules are FCC and CE Compliant Communications module can be used simultaneously with the tablet computer's integrated wireless (IEEE 802.11b) networking device

ACCESSORIES      

100-240 VAC Charger Power supply Battery Charger Blood pressure cuff Instructions Carrying case

OTHER  

One year limited warranty, extended warranty to three years Installation and training services available

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Terminology It is wise to spend a moment familiarizing yourself with some of the terminology that will be used to discuss simulation with the Newborn HAL system. Automatic Mode - In this mode, vital signs respond automatically to caregiver participation, instructor specifications, and pharmacologic intervention. The model used in this operating mode was developed based on physiologic principles. Features unique to this mode include: a comprehensive list of drugs for easy administration, a drug profile editor for adding new drugs or editing existing ones, among other things. Facilitator - the person conducting the simulation; an instructor or lab staff member. UNI - is the software application, used to control the simulator and evaluate care providers.

made to one profile have no effect on the others. Provider - a person participating in the simulation as a healthcare provider. Scenario - a saved sequence of physiological states, like a "playlist." 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 represent a fixed delay period ("Wait") or a pause ("Wait Indefinitely"). Stylus - a special pointing device for the tablet computer. The stylus is the fastest and easiest means of controlling the Newborn HAL software. See the Equipment Set-up section of this guide for more information on working with the stylus.

Palette - a collection of Palette Items. Each profile has its own palette. Palette Item - Any full or partial set of physiological parameters that have been grouped and saved together under a single name. Profile - a unique Newborn HAL software configuration, including custom Palette, Scenarios, and options. Each Profile acts as a separate program, in that changes

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Equipment Set-up

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Newborn HAL Battery Newborn HAL (S/N B1010788 or higher) includes two separate power adapters labeled “Newborn HAL Charger” and “Newborn HAL Power Supply”. Please review the use for each adapter before using the simulator for the first time. BATTERY LIFE Newborn HAL has a maximum battery runtime of approximately 3 hrs. Total runtime is dependent on the breathing rate, volumes, seizures, and muscle tone. The battery charge is displayed on the software panel after the connection with the simulator is established. For more information about the battery indicator, refer to Working with UNI section. WARNING: Do not store the simulator with a discharged battery. It is good practice to re-charge the battery at the end of every simulation session.

CHARGING THE BATTERY The simulator’s battery can only be recharged using the “battery charger”. In addition, the simulator must be off or in standby. The battery charger does not recharge the battery while the simulator is in use, nor does it keep the battery from discharging. Turn the simulator off and connect the battery charger to recharge the battery. To charge the battery: 1. Close the UNI software to turn the simulator off 2. Connect the adapter labeled “Newborn/Premie HAL Charger” to the battery port located on the simulator’s right side. 3. Allow the simulator to charge for 2-3 hours (or until the charger displays a green light). The charger indicator light will show red during the charge period and green once the process is complete.

If the simulator will not be used for an extended period, re-charge the battery at least once every 30 days. Doing so will prevent a reduction of the battery’s total charge capacity to self-discharge. 4. After the charger indicator light turns green, disconnect the

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charger. The simulator is ready for use.

4. The UNI battery icon will display a lightning icon when the power supply is connected.

Avoid using the simulator while the battery charger is connected. Please reference the troubleshooting guide for information on how to resolve battery issues. USING THE POWER SUPPLY (SYSTEM S/N B1010788 OR HIGHER) The “power supply” adapter allows the simulator to operate through long simulations sessions by drawing power from the wall outlet and not battery reserve. Use the power supply for simulation sessions lasting 2 hours or more. If simulation sessions are shorter than 2 hours, use the simulator’s battery reserve.

Please contact Gaumard for information on the power supply upgrade for earlier Newborn HAL models.

Control Table PC The tablet PC is preloaded with the UNI control software used by the facilitator to initialize the simulator and control the vital signs. Before turning on the computer for the first time, please review the documentation included with the product for important care and warning information.

USING THE STYLUS The “power supply” adapter will NOT re-charge the battery. Avoid using the “power supply” adapter when the simulator’s battery is completely depleted. To operate the simulator from wall power using the power adapter: 1. Fully recharge the simulator’s battery using the “Battery Charger” adapter.

The tablet’s stylus is a pen-shaped input used to interact with files and programs. 

Left click - tap the screen with the pointer. Tap twice rapidly to double-click.

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Right click - tap and hold a highlighted item or hold the button near the pointer and tap the item or text.

CALIBRATING THE STYLUS 2. Disconnect the “Charger” and connect the “Power Supply” adapter. 3. Activate the UNI software.

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As part of the initial setup process, calibrate the stylus using the Tablet and Pen calibration tool in the Windows® control panel. Complete the calibration process while holding

the pen in a natural writing position for greater accuracy during normal use. WIRELESS COMMUNICATION USB MODULE The controlling computer transmits the startup and control commands to simulator through the USB RF communication module. Connect the RF communication module to an available USB port on the tablet.

WARNING: Never disconnect the communications module while the Newborn HAL software is running. Doing so can seriously damage the module.

Virtual Monitor The Gaumard Monitors software displays NEWBORN HAL’s simulated vital signs in real time. The interactive monitoring software is preloaded in to the virtual monitors PC.

Secure the RF communication module to the tablet or PRO+ computer using the Velcro patch. The tablet is now ready to communicate with the simulator wirelessly. For information about the signal strength indicator, go to Working with UNI section

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VIRTUAL MONITOR PC SETUP Refer to the manufacturer’s documentation included with the virtual monitor system components for important safety, installation, and start-up information before turning on the computer for the first time. To setup the virtual monitor PC: 1. Place the all-in-one PC within line of sight of the controlling computer 2. Connect the power supply 3. Connect the USB keyboard and mouse receiver 4. Turn on the computer

GAUMARD MONITORS After the wireless connection is established, double click or tap the Gaumard Monitors icon to start the vital signs software.

VIRTUAL MONITOR WIRELESS CONNECTIVITY The control PC and the all-in-one virtual monitor PC automatically establish a wireless link at startup. The wireless connection allows the Gaumard control software to transmit the vital signs information to the Gaumard Monitors software. To verify the wireless link between the two computers, click the wireless icon located on the task tray. The wireless network name is configured at the factory and may differ from the one seen below. To troubleshoot connection issues between the virtual monitor computer and the controlling tablet, please go to the Appendix.

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The Gaumard Monitors software is now ready to receive the vital signs information generated by the UNI control software.

For more information about the Gaumard Monitors software, please refer to the Gaumard Monitors user guide.

Working with UNI

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Initializing the Simulator

The simulator selection menu is shown. Select Newborn HAL and click “Start”.

After reading the manufacturer’s care and caution information, press the power button to turn on the Tablet PC.

The UNI software initializes the simulator. Double click the UNI icon on the tablet’s home screen to start.

The wireless link between UNI and the simulator is established within 1 minute.

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PROFILES AND OPERATING MODES

The Manual mode includes the following profiles:

The UNI control software has two modes of operation: Manual and Automatic. Each mode includes a Quick Start profile with preprogrammed scenarios exercises created in conjunction with experienced healthcare instructors and working medical professionals. Continue to the next section to learn more about the each operating mode and the profiles included. The profiles can be accessed by clicking the Gear>File>Profile. After selecting an operating mode and profile, click “Load” to continue.

Default Profile – includes one palette with healthy vital signs. Quick Start Newborn HAL – includes eleven scenarios AUTOMATIC MODE The Automatic mode assists the facilitator by automatically adjusting vital signs in response to caregiver participation, pharmacologic intervention, and manual input. For example, when facilitator increases the heart rate, the Auto mode will calculate the response and adjust the blood pressure automatically. To activate the operating mode as an upgrade option, go to the digital UNI user guide.

MANUAL MODE In the “Manual” operating mode, the facilitator fully controls the vital signs and physiologic responses.

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Use the “Map Profiles folder“ icon to select the location of the new profile to be created on the server. The Automatic mode includes the following built-in profiles: Default Modeling– includes one palette with healthy vital signs. Meds Profile – This profile includes a library of pre-programmed drugs to be used on simulations. Quick Start Newborn Hal Modeling – includes eight lineal scenarios and one branching scenario allowing instant simulation of a wide range of conditions

Select the server location and click “Make New Folder” to create the profile folder.

MANAGING PROFILES

Use the Manage Profile Menu to create a new profile and edit this profile. In addition, the profile folder location will be shown below the “New Profile” icon. Assign a name to the folder and click “OK” The new profile folder location will show up. Then proceed to create a new profile, see instructions detailed below.

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