S3009 Premie HAL User Guide 16.4.1

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Contents Contents ... 3 End User License Agreement... 5 Care and Cautions... 8 Overall Warnings ... 9 Conductive Sites ... 10

Getting Started... 11 Overview ... 12 Terminology ... 14

Equipment Set-up... 15 Control Tablet Computer ... 16 Communication Module ... 16 Premie HAL Battery ... 17 Virtual Monitor ... 18 Gaumard Monitors ... 19

Working with UNI ... 20 Initializing the Simulator ... 21 UNI Interface ... 25 Quick Launch ... 27 Status / Details Controls ... 29 Modeling (Newborn/Premie) ... 33

Working with Premie HAL ... 35 Airway ... 37 Oral and Nasal intubation ... 37

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Airway Sounds ... 37 Suction... 37 Breathing ... 37 Respiratory Pattern... 37 Lung Sounds ... 37 Bilateral Chest Rise ... 37 Pulmonary Ventilation ... 37 Cardiac ... 38 Heart Sounds... 38 ECG Monitoring and Electrical Therapy ... 38 Chest compressions ... 38 Circulation ... 38 Palpable Pulses ... 38 Intravenous Access ... 38 Intraosseous Access ... 39 Systemic ... 40 Cyanosis... 40 Catheterization ... 41 Temperature Probe ... 41 Other ... 42 Vital Signs Monitor (Option) ... 42 Pro + (Option) ... 42

Appendix ... 43 More about Scenarios ... 44 Factory Preset Scenarios ... 44 More about scenarios ... 54 Troubleshooting ... 57 Wireless Network (Without USB Router)... 62 Wireless Network Instructions (With USB Router) ... 65 Replacement Parts ... 67 Warranty ... 70

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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

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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 MAKE ANY REPRESENTATIONS REGARDING THE USE OR THE RESULTS OF USE, OF THE SOFTWARE OR WRITTEN MATERIALS IN TERMS OF CORRECTNESS, ACCURACY, RELIABILITY, CURRENTNESS, OR OTHERWISE, AND THE ENTIRE RISK AS TO THE RESULTS AND PERFORMANCE OF THE SOFTWARE IS ASSUMED BY YOU. IF THE SOFTWARE OR WRITTEN MATERIALS ARE DEFECTIVE, YOU AND NOT GAUMARD OR ITS DEALERS, DISTRIBUTORS, AGENTS, OR EMPLOYEES, ASSUME THE ENTIRE COST OF ALL NECESSARY SERVICING, REPAIR OR CORRECTION OTHER THAN EXPRESSLY DESCRIBED ABOVE. (C) NEITHER GAUMARD NOR ANYONE ELSE WHO HAS BEEN INVOLVED IN THE CREATION, PRODUCTION OR DELIVERY OF THIS PRODUCT SHALL BE LIABLE FOR ANY DIRECT, INDIRECT, CONSEQUENTIAL OR INCIDENTAL DAMAGES (INCLUDING DAMAGES FOR LOSS OF BUSINESS PROFITS, BUSINESS INTERRUPTION, LOSS OF BUSINESS INFORMATION, AND THE LIKE) ARISING OUT OF THE USE OR INABILITY TO USE SUCH PRODUCT OR RELATED TO THIS AGREEMENT EVEN IF GAUMARD HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. GAUMARD SHALL NOT BE LIABLE TO YOU FOR ANY INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES OR LOST PROFITS ARISING OUT OF OR RELATED TO THIS AGREEMENT OR YOUR USE OF THE SOFTWARE AND/OR THE RELATED DOCUMENTATION, EVEN IF GAUMARD HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. IN NO EVENT SHALL GAUMARD'S LIABILITY HERE UNDER, IF ANY, EXCEED THE PURCHASE PRICE PAID BY YOU FOR THE SOFTWARE.

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ALL RIGHTS NOT EXPRESSLY GRANTED IN THIS LICENSE AGREEMENT ARE RESERVED BY GAUMARD. ACKNOWLEDGMENT BY INSTALLATION OF THIS SOFTWARE, YOU ACKNOWLEDGE THAT YOU HAVE READ AND UNDERSTAND THE FORE GOING AND THAT YOU AGREE TO BE BOUND BY ITS TERMS AND CONDITIONS. YOU ALSO AGREE THAT THIS AGREEMENT IS THE COMPLETE AND EXCLUSIVE STATEMENT OF AGREEMENT BETWEEN THE PARTIES AND SUPERSEDES ALL PROPOSED OR PRIOR AGREEMENTS, ORAL OR WRITTEN, AND ANY OTHER COMMUNICATIONS BETWEEN THE PARTIES RELATING TO THE LICENSE DESCRIBED HEREIN.

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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 60 days to prevent damage. Do not attempt to intubate without lubricating the airway adjunct with a silicone 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. Premie 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.

Store Premie 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 Premie HAL at an ambient temperature of 95 degrees Fahrenheit (35 Celsius). Premie 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 Premie 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 Premie HAL is in operation. Doing so will cause damage to the system.

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Do not pull or carry the simulator by the limbs. Handle Premie HAL with the same care as a human patient. WARNING: To avoid damage to the simulator, please store and ship it in the clear poly bag provided. 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.

Conductive Sites Premie 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. Premie HAL does not accept real electrical therapy. Do not pace or defibrillate Premie HAL with real electrical equipment.

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

Overview GENERAL  

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Tetherless and fully responsive even while being transported Powered from an internal rechargeable battery or wall outlet using power adapter Battery capable of 300 recharges and Simulator receives commands from a wireless tablet PC and operate at distances up to 150 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    

Oral and nasal intubation Use an ET tube or LMA Unilateral chest rise with right main stem intubation Multiple upper airway sounds synchronized with breathing

APPEARANCE 

Color responds to hypoxic events and interventions (healthy, mild cyanosis, severe cyanosis)

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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 Palpable fontanelle, brachial, femoral, and umbilical pulse sites Pulse strengths vary with blood pressure and pulses are synchronized with ECG

SIMULATOR     

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 adapter Battery Charger Instructions Carrying case

OTHER 

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One year limited warranty, extended warranty to three years option 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 Premie 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. 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 Premie HAL software configuration, including custom Palette, Scenarios, and options. Each Profile acts as a separate program, in that changes

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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 Premie HAL software. See the Equipment Set-up section of this guide for more information on working with the stylus.

Equipment Set-up

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Control Tablet Computer The touchscreen tablet computer serves as the simulator’s control center. Startup and control commands are sent from the Gaumard control software (UNI) to the simulator wirelessly using the RF communication module shown in the next section. Please refer to the computer’s documentation for important user and safety information before powering on the tablet computer for the first time.

four corners of the screen. Position yourself and the tablet as if you are working, and carefully touch the exact center of each of the targets. After calibration, the pointer should be displayed directly beneath the stylus tip. Significant changes to viewing angle should be followed by calibration for best performance.

Communication Module Connect the RF communication module to an available USB port on the tablet’s/PRO+ left side.

USING THE STYLUS The stylus operates very much like a mouse. You will notice that the pointer moves when the stylus is held near, but without touching the screen. Tapping the screen with the stylus tip is like clicking the primary (usually left) mouse button. Holding the stylus button while tapping the screen is like clicking the secondary (usually right) mouse button.

Secure the RF communication module to the tablet or PRO+ computer using the Velcro patch.

CALIBRATING THE STYLUS For working with the Gaumard control software and many other applications, the stylus input is far superior to a mouse in both speed and comfort. An additional advantage is it can be easily calibrated for your personal comfort. The calibration utility found in the control panel will present the user with crosshair targets at each of the

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The tablet is now ready to communicate with simulator.

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

Premie HAL Battery Premie HAL (S/N p6009067 or higher) includes two separate power adapters labeled “Premie HAL Charger” and “Premie HAL Power Supply”. Before using the simulator for the first time, reference the use for each adapter below. CHARGING THE BATTERY To charge the battery, connect the adapter labeled “Premie HAL Charger” to the battery port and charge Premie HAL 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. The simulator’s battery charges only when the control software is disabled.

Avoid using the simulator while the battery charger is connected. If the simulator is in use while the charger is connected, the battery will not charge. To charge the battery you must: 1. If connected, unplug the charger adapter from the simulator and the wall outlet. 2. Turn off the simulator by closing the UNI control software. 3. Re-connect the charger adapter to the wall outlet and the simulator’s battery port. 4. Leave the simulator charging for 2-3 hours with the UNI control software disabled. BATTERY LIFE Premie HAL has a maximum battery runtime of approximately 2 hrs. Total runtime is dependent on factors such as breathing rate and sounds. The battery status is displayed on the software status panel after the connection with the simulator is established. For more information about the battery indicator, refer to “Working with UNI” section. Warning: 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 internal battery.

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USING THE POWER SUPPLY (SYSTEM S/N p6009067 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. 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 use the power supply adapter: 1. Fully charge the simulator’s battery using the “Charger” adapter. 2. Disconnect the “Charger” and connect the “Power Supply” adapter. 3. Activate the UNI software. 4. The UNI battery icon will display a lightning icon when the power supply is connected. Please contact Gaumard for information on the power supply upgrade for earlier Premie HAL models.

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Virtual Monitor The optional virtual patient vital sign monitor system works with UNI to receive and display the simulator’s vital sign information. The system includes an all-in-one touchscreen computer and the Gaumard Virtual Monitor software. EQUIPMENT SETUP Please refer to the documentation included with the all-in one computer for important safety, installation, and start-up information. Secure all the system’s connection and power on the touchscreen computer as indicated by the product’s documentation. WIRELESS AD-HOC CONNECTIVITY The tablet and virtual monitor computer automatically establish an ad-hoc (computer-to-computer) wireless connection at startup. The wireless connection between both systems allows UNI to update the vital signs information displayed on the Gaumard Monitors program. To verify the connection between the computers, click on the wireless icon located on the task tray of both the tablet and virtual monitor. For troubleshooting information on the ad-hoc connectivity, navigate to the Appendix.

The Gaumard Virtual Monitor software is now ready to receive vital sign information.

Gaumard Monitors After the ad-hoc connection is established, double click or tap the Gaumard Virtual Monitors icon located on the virtual monitor’s home screen.

To learn more about the Gaumard Monitors features and functionality, click then V menu and select Help to open a digital copy of the Gaumard Virtual Monitor User Guide.

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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: Default Profile – includes one palette with healthy vital signs. Quick Start Newborn HAL – includes basic preprogrammed scenarios AUTOMATIC MODE

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 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.

After selecting an operating mode and profile, click “Load” to continue. MANUAL MODE In the “Manual” operating mode, the facilitator fully controls the vital signs and physiologic responses.

The Automatic mode includes the following built-in profiles: Default Modeling– includes one palette with healthy vital signs.

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