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Gaumard Sales Terms and Conditions | 79

PEDIATRIC HAL®

 | 

User Guide

A PARTICULAR PURPOSE, OR NON-INFRINGEMENT. SUCH LIMITED WARRANTY IS GIVEN SOLELY TO THE ORIGINAL CUSTOMER AND IS NOT 
GIVEN TO ANY THIRD PARTY INCLUDING, WITHOUT LIMITATION, SUBSEQUENT PURCHASERS OR USERS OF THE PRODUCTS OR CUSTOMERS 
OF THE CUSTOMER. THIS WARRANTY IS VOID UPON TRANSFER OF PRODUCT BY CUSTOMER TO ANY OTHER ENTITY. SOME STATES DO NOT 
ALLOW THE EXCLUSION OF IMPLIED WARRANTIES SO THE ABOVE EXCLUSIONS MAY NOT APPLY TO CUSTOMER. These warranties do not apply 
to any Products that are supplied on a pre- release or “as-is” basis.

8. 

Warranty Claims and Remedies. In the event of any warranty claim, Gaumard will replace with new or repaired items any Product part or 

component that is in breach of the above limited warranties. Alternatively, Gaumard may elect to repay or credit to Customer an amount equal to 
the purchase price of the defective Product. Items replaced shall become Gaumard property. All claims shall be  initiated  by  contacting Gaumard 
within the applicable Warranty Period and within thirty (30) days after discovery of the non- conformity. If Customer has failed to notify Gaumard 
within the Warranty Period, then Customer shall be barred from instituting any action thereafter. Customer shall not return the Product to Gaumard 
without prior authorization from Gaumard. If the necessary repairs to the Product are covered by this limited warranty,  then Customer will pay only 
the incidental expenses associated with the repair, including any shipping, handling, and related costs for sending the product to Gaumard and for 
sending the product back to the first purchaser. However, if the repairs are not covered by this limited warranty, then Customer will be liable for all 
repair costs in addition to costs of shipping and handling. Upon request, Gaumard must be given access to and an opportunity to inspect the Product 
and any working areas and storage areas. These remedies shall comprise Gaumard’s entire liability and Customer’s exclusive remedy for breach of 
warranty and are in lieu of any other remedies at law or equity.

9. 

LIMIT OF LIABILITY. GAUMARD SHALL NOT BE LIABLE FOR ANY SPECIAL, INCIDENTAL, PUNITIVE, EXEMPLARY, OR CONSEQUENTIAL 

LOSSES, DAMAGES, OR EXPENSES (INCLUDING BUT NOT LIMITED TO LOSS OF PROFITS, DATA, OR USE), DIRECTLY OR INDIRECTLY ARISING FROM 
THE SALE, HANDLING, SERVICE, OR USE OF PRODUCT OR SERVICES ORDERED OR FURNISHED, OR FROM ANY CAUSE RELATING THERETO. 
EXCEPT FOR PERSONAL INJURY OR DEATH TO THE EXTENT RESULTING FROM GAUMARD’S NEGLIGENT OR INTENTIONALLY WRONGFUL ACTS 
OR OMISSIONS, IN NO EVENT SHALL GAUMARD BE LIABLE UNDER ANY LEGAL THEORY OR FOR ANY CAUSE RELATED TO A PRODUCT OR 
SERVICE, WHETHER BASED UPON WARRANTY, CONTRACT, TORT, NEGLIGENCE, OR OTHER THEORY, EVEN IF ADVISED OF THE POSSIBILITY 
THEREOF, FOR ANY AMOUNT IN EXCESS OF THE PRICE, FEE, OR CHARGE RECEIVED BY GAUMARD FOR SUCH PRODUCT OR SERVICE.

10. 

Governmental Authorizations. Customer is responsible for compliance and costs associated with all required licenses, permits, or other 

governmental authorizations, including but not limited to, any license or certification needed for Customer to use the Product, and any export or 
import license, exchange permit, or the like (“Licenses”), even if applied for by Gaumard on Customer’s behalf. If any authorization is delayed, denied, 
revoked, restricted, or not renewed, Gaumard shall not be liable, and Customer is not relieved of its obligations. Customer represents and agrees that 
it will handle all Product and technical data related to the Licenses so that it conforms to all applicable U.S. laws and regulations, including U.S. export 
licensing laws and the U.S. Foreign Corrupt Practices Act. Customer shall not trans-ship, divert, re-export or otherwise dispose of any U.S. origin 
goods or technology obtained from Gaumard except as U.S. laws and regulations expressly permit.

11. Indemnity.

a. 

Gaumard agrees to indemnify, defend and hold Customer, its officers, directors, employees, agents and contractors harmless from and 

against all loss, damage, liability, cost and expense (including reasonable attorneys’ fees and expenses) by reason of any claims or actions by 
third parties against Customer for (1) bodily injury or death, and damage, loss or destruction of any real or tangible personal property, which third 
party claims arise out of or relate to Gaumard’s gross negligence or willful misconduct or (2) infringement or misappropriation by Gaumard of any 
intellectual property rights under this Agreement.

 b. 

Customer agrees to indemnify, defend and hold Gaumard, its officers, directors, employees, agents and contractors harmless from and 

against all loss, damage, liability, cost and expense (including reasonable attorneys’ fees and expenses) by reason of any claims or actions by third 
parties against Gaumard for (1) bodily injury or death or damage, loss or destruction of any real or tangible personal property, which third party claims 
arise out of or relate to Customer’s gross negligence or willful misconduct; (2) infringement or misappropriation by Customer of any intellectual 
property rights; or

(3) Customer’s or its customer’s use of the Products or Services, including without limitation, defamation, libel, slander, obscenity, pornography, or 
violation of the rights of privacy or publicity, or spamming or any other tortious or illegal conduct.

12. 

Software License. For purposes of these Terms, the term “Software” includes all Gaumard computer software, firmware, and associated 

documentation, whether in printed or machine-readable form, supplied by reason of this Agreement or for use in connection with Equipment or 
Services. To the extent the Product includes Software, Customer’s use of the Software is governed by the Gaumard End User License Agreement 
attached as Exhibit A to these Terms.

13. 

Confidential Information. Customer shall maintain the confidentiality of any information provided or disclosed by Gaumard relating to the 

Software (as defined above), business or customers of Gaumard, as well as this Agreement and its terms (including the pricing and other financial 
terms under which the Customer will be obtaining the Services hereunder). Customer shall use reasonable care to protect the confidentiality of 
Gaumard’s information disclosed, but no less than the degree of care it would use to protect its own confidential information, and shall only disclose 
Gaumard’s confidential information to its employees and agents having a need to know this information and who are subject to confidentiality 
agreements having terms at least as restrictive as those contained herein. The obligations of confidentiality set forth herein shall not apply to any 
information in the public domain at the time of disclosure.

14. 

Intended Uses. Products are only intended for the uses described in the applicable user’s manual or instructions for use. Customer assumes 

all risks associated with non-listed uses of Products and hereby indemnifies and holds Gaumard harmless from any claim associated with such non-
listed uses.

15. 

Compliance with Laws. Gaumard and Customer agree to comply with all federal and state laws that govern the enforceability and 

performance of this Agreement.

16. 

HIPAA Compliance. As of the Effective date, the Parties are not planning to transfer any personal patient information between them. 

However, the Parties understand and agree that this Agreement may become subject to the Health Insurance Portability and Accountability Act of 
1996 as amended (“HIPAA”), the privacy and security regulations promulgated thereunder, including 45 C.F.R. 160, 162 and 164, as amended (the 
“HIPAA Regulations”), and Title XIII of Division A and Title IV of Division B (the “Health Information Technology for Economic and Clinical Health Act 

Summary of Contents for PEDIATRIC HAL S3004

Page 1: ...sist a certified instructor It is not a substitute for a comprehensive understanding of the subject matter and not intended for clinical decision making User Guide 18 7 1 Gaumard Scientific Company 20...

Page 2: ......

Page 3: ...TERY 12 3 4 S3005 HAL 5 YEAR S BATTERY 15 3 5 INITIALIZING THE SIMULATOR WITH UNI 16 4 WORKING WITH PEDIATRIC HAL 18 4 1 NEUROLOGICAL 18 4 2 RECOMMENDED DEVICE SIZES 20 4 3 AIRWAY 20 4 4 BREATHING 24...

Page 4: ...T DETECTED 73 8 APPENDIX 76 8 1 SPARE PARTS LIST 76 8 2 EXCLUSIVE ONE YEAR LIMITED WARRANTY 77 8 3 EXTENDED WARRANTY 77 8 4 GAUMARD SALES TERMS AND CONDITIONS 78 8 5 END USER LICENSE AGREEMENT 81 8 6...

Page 5: ...annot be removed Do not use povidone iodine on the simulator Replacement parts are available from Gaumard Scientific or from your distributor Please refer to the Appendix for Gaumard s Sales Terms and...

Page 6: ...damage the skin CAUTION To avoid damage to the simulator store and ship it in the clear poly bag provided Procedures Do not attempt to intubate without lubricating the airway adjunct with mineral oil...

Page 7: ...sidues after every use Failure to do so will leave behind a film of electrode gel that hardens causing arcing and pitting To aid removal of ECG gel sprinkle baby powder on the residual ECG gel to dry...

Page 8: ...tion Improper esophageal intubation causes visible gastric distension Breathing Programmable spontaneous breathing Independent left or right lung sounds synchronized with breathing Bilateral lung expa...

Page 9: ...t rates Perform measure and log CPR and depth of chest compressions in the software Circulation Bilateral pulses carotid brachial radial and femoral depend on blood pressure and are synchronized with...

Page 10: ...der A person participating in the simulation as a healthcare provider Scenario A saved sequence of physiological states like a play list Scenarios provide a level of automation that unburdens the faci...

Page 11: ...e weight of a real patient It is recommended that HAL s head rest flat on the bed or on a thin pillow to prevent the face skin from shifting 3 2 PACKAGE CONTENTS 1 Carrying Case 2 Neck Brace 3 Short 4...

Page 12: ...ery Recharge the battery at the end of every simulation session 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 damagin...

Page 13: ...rve Use the power supply for simulation sessions lasting 2 hours or more If simulation sessions are shorter than 2 hours using the simulator s battery reserve is recommended CAUTION The power supply a...

Page 14: ...s battery using the battery charger adapter 2 Disconnect the charger and connect the power supply adapter 3 When connecting the power supply to the simulator s port make sure the pins on the power sup...

Page 15: ...volumes and seizures Charging the S3005 HAL Battery 1 Close the UNI software to turn the simulator off 2 Connect the adapter labeled Pediatric 5 Year HAL Charger to the battery port located on the sim...

Page 16: ...the simulator will not be used for an extended period re charge the battery at least once every 30 days Doing so will prevent damaging the battery due to discharging 3 5 INITIALIZING THE SIMULATOR WIT...

Page 17: ...lator will establish communication and turn on 7 To turn off the simulator close the UNI software Adding a Serial Number to the Profile 1 Select the desired profile 2 Click the button to the right of...

Page 18: ...only if needed Reactive Eyes The simulator has programmable blinking eyes and pupils that dilate Use the software controls to change the blinking rate and to enable or disable pupil reaction 1 Click...

Page 19: ...n you may click Increase or Decrease to adjust pupil s sensitivity to light 4 Once finished adjusting pupil sensitivity click Finish Seizures The simulator is capable of convulsing to simulate none mi...

Page 20: ...ubes and Laryngeal Mask Airways LMA 4 2 RECOMMENDED DEVICE SIZES Procedure S3005 5 Year S3004 1 Year Intubation Blade size Miller 2 or MAC 3 MIller1 LMA Size 2 2 25 Size 1 5 2 Nasal Intubation 12 Fr c...

Page 21: ...PEDIATRIC HAL User Guide Working with Pediatric HAL 21 Intubation 1 Set the simulator s respiratory rate to 0 2 Lubricate the ET tube or airway adjunct with mineral oil 3 Intubate the simulator...

Page 22: ...the esophagus will lead to visible gastric distension To relieve the gastric distension gently press down on the stomach Airway Sounds The simulator produces audible throat sounds Locate the Throat So...

Page 23: ...bolts located on either side of the midsection 3 Gently slide the skin off each bolt and lift the chest skin to expose the airway 4 Remove the punctured cricoid tape from the airway and clean away an...

Page 24: ...he breathing rate Adjust the virtual inspiratory percentage Lung Sounds The simulator generates anterior and posterior sounds Available lung sounds include normal none wheezing inspiratory squeaks cra...

Page 25: ...me bar Ventilation Complete the ventilation calibration process before using the ventilation feature for the first time 2 Ventilate the simulator using a standard bag valve mask BVM 3 Open the CPR win...

Page 26: ...process 1 Click the blue gear icon in the upper right hand corner of the UNI software then click Setup Calibration Ventilations and click Next 2 After clicking Next on the Calibration window select t...

Page 27: ...you would with a human patient The simulator s ECG sites can generate detectable waveforms using real medical equipment and standard electrodes Real automated external defibrillators can detect the si...

Page 28: ...WARNING Defibrillation pacing and cardioversion is only supported on the large sternum and apex sites defib posts circled RED Do not deliver a shock to ECG electrode sites on the shoulders or waist ci...

Page 29: ...ed with the heart rate and selectable rhythms The software controls allow the user to change the heart sound type and adjust the volume level to auscultate with a stethoscope Changing the Heart Sound...

Page 30: ...the UNI software under the Cardiac section 2 Move the gray slide bar or type in the desired rate to adjust heart rate Chest Compressions Set the simulator in a heart rhythm that requires chest compre...

Page 31: ...Perform the actions requested by the calibration wizard emulating the most current CPR guidelines 1 To calibrate the compression performance benchmark click the blue gear icon in the upper right hand...

Page 32: ...compression when prompted for a total of five 5 compressions A green oval will indicate that the compression was successfully recorded 6 Follow the cues on the calibration window After performing the...

Page 33: ...lses The simulator s palpable pulses are blood pressure dependent to simulate life like responses Use the software controls to independently disable radial pulses Disable Radial Pulse 1 Select the Pul...

Page 34: ...empt to fill IV system without the drain connector in place Always leave the drain port connected when injecting fluids into the system Use only Gaumard s artificial blood concentrate or clean water t...

Page 35: ...h the desired fluid water or simulated blood 4 Connect the fill syringe to the other port 5 Push fluid into the system until the fluid exits through the drainage tube into the receptacle and all the a...

Page 36: ...rm S3004 One Year Old HAL 1 To prime the IV arm locate the fill syringe kit and port adapters Fill the syringe with fluid 2 Connect the fill kit adapters to the forearm 3 Connect the drain tube to one...

Page 37: ...diatric HAL 37 6 Disconnect the fill syringe from the port and screw in a closed capped adapter The IV arm is now ready for use 5 Push the fluid through the system until there are no air bubbles then...

Page 38: ...atient with no accessible peripheral IV sites connect the fill syringe to one of the arm ports 3 Disconnect the fill syringe from the port while maintaining suction This will cause the port to seal an...

Page 39: ...ollow bones allow for aspiration and infusion of fluid using real medical devices Model Maximum Infusion Volume mL S3004 HAL 1 Year Old 8 S3005 HAL 5 Year Old 18 2 Remove the tibia insert 3 Remove the...

Page 40: ...caps 5 Use the fill kit syringe to fill the bone reservoir with fluid 6 Insert the tibia bone in the leg and attach the skin cover NOTE Intraosseous access is only supported on the hollow tibia inser...

Page 41: ...der Before using the blood pressure feature for the first time place the modified cuff on the left arm and calibrate it using the calibration wizard Blood Pressure Calibration 1 Place the blood pressu...

Page 42: ...select Blood Pressure Cuff and click Next 5 Set the pressure on the cuff to 0 mmHg Then click the OK button NOTE After clicking OK the calibration window will prompt for the blood pressure cuff to be...

Page 43: ...While adjusting the cyanosis the Hypoxia tab monitors treatment of cyanosis to show either improvement or deterioration of the condition Adjusting Cyanosis Intensity 1 Under the Cephalic section in t...

Page 44: ...ation exercises Model Max Infusion Volume mL Catheter Size S3004 HAL 1 Year 48 8 Fr S3005 HAL 5 Year 90 8 10 Fr Straight Rigid Filling the Bladder 1 Place the simulator face down to reveal the bladder...

Page 45: ...ean the reservoir with a water and isopropyl alcohol 70 30 ratio mixture to prevent mold from forming 4 7 GASTRIC Pediatric HAL simulates normal hyperactive or no bowel sounds The bowel sounds may be...

Page 46: ...Select either Upper Right Lower Right Upper Left or Lower Left 4 Once the desired bowel location is selected a pop up menu will prompt you to enable or disable the bowel sound for the specific locatio...

Page 47: ...included with the CO2 cartridge package Never point a CO cartridge at yourself or others Do not use damaged CO cartridges Do not puncture the cartridge CO seal manually Do not expose the CO cartridges...

Page 48: ...de already please refer to the Removing the Cartridge section below 3 Align and insert the new cartridge into its slot on the bottom half of the protective case ensuring that the threads are aligned 4...

Page 49: ...t it back on firmly WARNING Hand tighten ONLY Do NOT over tighten Connecting the Cartridge to the Simulator 1 Secure the cartridge to the simulator by using the Velcro strap 2 Bring the CO2 connecting...

Page 50: ...he UNI software to increase or decrease the volume of exhaled CO2 3 Ensure the connections are firmly secured and locked in place before proceeding with use NOTE If needed the cartridge may be placed...

Page 51: ...d Activating CO2 Output 1 Under the Breathing section select Lung CO2 2 Use the gray slide bar that ranges from 0 10 or type in the value to adjust the level of CO2 exhaled To deplete the CO2 cartridg...

Page 52: ...en the top comes off of the protective casing you will see the cartridge 6 With the cartridge completely spent twist the cartridge counter clockwise to unfasten it for removal 7 Remove the cartridge W...

Page 53: ...can bleed real fluid through a precut opening on the fingertip The feature allows participants to practice finger stick technique and collect simulated blood samples CAUTION Use only Gaumard s provide...

Page 54: ...ith Pediatric HAL Instructions for Use 1 Power the simulator ON and locate the black port on the simulator s right forearm 2 Fill the syringe with up to 2 CCs of fluid 3 Connect the syringe to the bla...

Page 55: ...PEDIATRIC HAL User Guide Working with Pediatric HAL 55 5 Remove the fill syringe 6 Enable the feature in the UNI software...

Page 56: ...opropyl alcohol 2 Locate the black port on the right forearm of the simulator an connect the syringe to the black port 3 Inject 2CC of the water and isopropyl alcohol mix 4 Enable the feature in the U...

Page 57: ...tware The UNI control elements and scenario programming procedures are consistent throughout the Gaumard family of high fidelity simulators Some software controls and features covered in this guide ma...

Page 58: ...components The simulator will not initialize until it has been recharged Before the simulator shuts off due to a depleted battery a message will pop up on the screen to notify the user of the low batt...

Page 59: ...button is located on the bottom right corner of the UNI software Use the stand by feature to conserve battery Quick Launch The UNI interface opens to the quick launch page listing the scenarios This p...

Page 60: ...ay be categorized by clinical conditions on the left of the Quick Launch page i e asthma intoxication etc Selecting a Scenario 1 Click on one of the scenarios listed to highlight it then click Start S...

Page 61: ...tar icon 2 Select the desired categories or scenario types Once the category or scenario is selected it will appear highlighted with a check in the box to the left of the title Status Details Controls...

Page 62: ...PEDIATRIC HAL User Guide 62 Working with UNI Systems List View The vital signs controls are divided into separate categories Cephalic Airway Breathing Cardiac Circulation Bowel...

Page 63: ...he slider control 3 To change patterns sounds and rhythms click on the specific control to display the library e g EKG rhythms heart and lung sounds respiratory patterns etc 4 Click the slider control...

Page 64: ...r the list of changes is created click NOW to update the vital signs instantly You may also click a trending time to update numerical vital sign parameters e g heart rate blood pressure gradually Enab...

Page 65: ...ed to update all the cardiac parameters to a healthy state 1 To create a new palette item set the values for the desired vital signs parameters using the Details control panel and click Save 2 Enter a...

Page 66: ...amically in response to effective ventilations The model also responds to the administration of virtual drugs Hypoxia Model State The hypoxia model options improve or deteriorate the cardiac and respi...

Page 67: ...c and vital signs are rapidly worsening Modeled Therapy The modeled therapy menu provides additional intervention options Improve Gain Adjust the slider to increase or decrease the cyanotic response t...

Page 68: ...he blood pressure automatically The Automatic Mode includes the following built in profiles Default Modeling Includes one palette with healthy vital signs Meds Profile This profile includes a virtual...

Page 69: ...C HAL User Guide Working with UNI 69 Switching to Automatic Mode 1 Click the gear icon in the upper right hand corner of the UNI software then File Profile 2 Under Running Mode select Automatic and cl...

Page 70: ...nvironmental noise to improve audio quality Activate Streaming Audio Select the duplex streaming audio icon located on the bottom right of the UNI software to activate the simultaneous listening and s...

Page 71: ...i icon The wireless network name is configured at the factory and may differ from the one seen here Be sure both the control computer that runs UNI and the virtual monitor that runs Gaumard Monitors a...

Page 72: ...ratio and connect the fill syringe and the drain tube to the arm 2 Push the water and isopropyl alcohol mixture until the fluid that exits the drain tube is clear 3 Once the fluid runs clear fill the...

Page 73: ...tor not connecting Check that both computers tablets are connected to the same wifi network check that firewalls are turned off on both computers tablets check that the IP Port numbers match from the...

Page 74: ...ftware to control and display vitals signs consider checking the IP address for the software Checking the IP address 1 Open and load UNI on the control PC then click the gear icon in the upper right c...

Page 75: ...In the upper left hand corner click the signal icon that is next to the V icon 5 The Wireless Communication Setup pop up window will appear Click Stop 6 Enter the IP address and port number from the...

Page 76: ...trate Simulated blood S3005 181 Mineral oil Oil based mineral lubricant S3005 082 Trachea Tape Trachea tape pink S3004 Pediatric HAL 1 Year S3004 Part ID Name Description S3004 010 Battery Rechargeabl...

Page 77: ...oduced by Gaumard This limited warranty does not apply to any products provided along with the Gaumard product that are manufactured by third parties For example third party products such as computers...

Page 78: ...shipped F O B Origin regardless of any provisions for payments of freight insurance the form of shipping documents or selection of carrier by Gaumard F O B Origin means title to the Products passes t...

Page 79: ...e of any U S origin goods or technology obtained from Gaumard except as U S laws and regulations expressly permit 11 Indemnity a Gaumard agrees to indemnify defend and hold Customer its officers direc...

Page 80: ...by applicable bankruptcy laws a Party to this Agreement may elect to terminate this Agreement including any Purchase Orders if any of the following situations arise 1 the other Party becomes insolven...

Page 81: ...h notice period without liability arising from such termination The parties agree that all information needed for interoperability is available from Gaumard in accordance with applicable government di...

Page 82: ...r obligations under this EULA without the prior written consent of the other party except that either party may assign this Agreement to any entity controlled by controlling or under common control wi...

Page 83: ...o the simulator for possible troubleshooting as needed Technical Support Email support gaumard com USA 800 882 6655 INT 01 305 971 3790 8 7 GENERAL INFORMATION Sales and Customer Service E mail sales...

Page 84: ...Appendix 84 PEDIATRIC HAL User Guide...

Page 85: ...e Krash Kids Premie UNI Omni Omni 2 SmartSkin are trademarks of Gaumard Scientific Company Always dispose of this product and its components in compliance with local laws and regulations www gaumard c...

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