background image

Gaumard Sales Terms and Conditions | 58

S405.100 & S406.100

USER GUIDE

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 
(“HITECH”), part of the American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5) (“ARRA”). The Parties agree to strictly comply with HIPAA 
and to execute any documents that may be required by HIPAA, HITECH, and any other applicable federal or state privacy laws and regulations. The 
Parties agree that if they directly or indirectly gain access to Protected Health Information (“PHI”) held by the other Party during any interaction, the 
receiving Party will keep the PHI confidential under the terms of this Agreement

17. 

State Reporting and Disclosure Laws. Unless otherwise noted in this Agreement, the cost of any Product training provided by Gaumard 

sHAL®l be included in the purchase price of the Product where applicable. Customer acknowledges and agrees that state reporting laws may require 
Gaumard to disclose certain aspects of this arrangement.

 18. 

Fraud and Abuse. Gaumard hereby certifies that it is not currently a listed vendor in the: (a) Federal General Services Administration’s “List 

of Parties Excluded from Federal Procurement or  Nonprocurement Programs” in accordance with Presidential Executive Orders 12549 and 12689 
“Debarment and Suspension;” and (b) in the Office of the Inspector General of the Department of Health and Human Services’ “List of Excluded 
Individuals/Entities.” Any discounted pricing terms offered under this Agreement may be a “discount or other reduction in price” under the Federal 
Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b). Customer sHAL®l take all actions necessary to comply with the Anti-Kickback Statute discount safe 
harbor regulations, 42 C.F.R. § 1001.952(h), including but not limited to, (1) maintaining accurate records reflecting the pricing terms of items and 
Services purchased under this Agreement, (2) fully and accurately report any discount received under this Agreement if applicable, and (3) make 
available information provided to Customer by Gaumard concerning cost reports and other filings with the government, including but not limited to, 
the Secretary of the U.S. Department of Health and Human Services or other state agencies.

19. 

Bankruptcy. Except as may be prohibited 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 insolvent or is unable to pay debts as they 
become due; (2) a voluntary or involuntary bankruptcy proceeding is instituted by or against a Party hereto; or (3) an appointment of a receiver or 
assignee for the benefit of creditors occurs on beHAL®f of a Party hereto.

20. 

Waiver and Severability. If either Party fails to perform obligations under this Agreement, such nonperformance sHAL®l not affect the other 

Party’s right to enforce performance at any time. Waiver of any remedy or material breach of any subject matter contained in this Agreement sHAL®l 
not be viewed as a waiver unless agreed to by the Parties in writing. Each provision of this Agreement is separate and independent of one another, 
and the unenforceability of any provision will not affect the enforceability of any other  provision. If any provision is held to be excessively broad or 
unenforceable, such provision sHAL®l be modified so that it is enforceable to the fullest extent possible by law.

21. 

Assignment. Customer sHAL®l not assign this Agreement without the prior written consent of Gaumard, which consent sHAL®l not be 

unreasonably withheld or delayed. Subject to the foregoing, the rights and obligations herein will be binding upon the successors and assigns of 
Customer.

22. 

Notices. Any required notices will be given in writing to Gaumard as set forth in the applicable Gaumard Purchase Order or other purchasing 

document.

23. 

Governing Law. Upon execution, this Agreement sHAL®l be governed and viewed under the laws of the State of Florida without reference 

to its conflict of laws provisions. Customer and Gaumard specifically agree that any action relating to the relationship between the Parties, the 
Agreement, or Products provided, purchased or licensed hereunder, sHAL®l be brought and tried in the Courts of Dade County, Florida. Customer 
waives all objections to, and consents to the jurisdiction of such Courts.

24. 

Miscellaneous. See applicable Gaumard Purchase Order documents, Gaumard Warranty documents, and Gaumard Cares Service Plan 

documents for other terms and conditions, which may include, but are not limited to: Term, Termination, Customer Training and Support, and Product 
Repairs and Tune Ups.

7.3 END USER LICENSE AGREEMENT 

 

GAUMARD END USER LICENSE AGREEMENT

This End User License Agreement (“EULA”) sets forth the respective rights and responsibilities between the entity named in the Purchase Order 

associated with this EULA (“End User”) and Gaumard Scientific Company, Inc., a Florida corporation (“Gaumard”), relative to the Gaumard Software 

(as defined below). This EULA is effective as of the date Gaumard accepts and confirms the Purchase Order (the “Effective Date”). BY USING THE 

GAUMARD SOFTWARE, END USER IS AGREEING TO BE BOUND BY THE TERMS OF THIS EULA. IF END USER DOES NOT AGREE, END USER MAY 

NOT USE THE GAUMARD SOFTWARE.

1. Definitions.

1.1 “Gaumard Documentation” means the Gaumard user and operations manuals, guides, and related materials provided by Gaumard to End User to 

facilitate use of the Gaumard Products.

1.2 

“Gaumard Equipment” means Gaumard hardware components for medical simulation and training, including manikins and associated 

instrumentation, and other hardware and tangible products sold by Gaumard to End User.

1.3 “Gaumard Products” means Gaumard Software licensed and Gaumard Equipment sold or otherwise made available by Gaumard to End User 

currently or in the future.

Содержание S405.100

Страница 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 20 10 02 Gaumard Scientific Company...

Страница 2: ......

Страница 3: ...3 2 PACKAGE CONTENTS 10 3 3 IDENTIFYING ARTERIAL AND VENOUS TUBING 11 3 4 BLOOD RESERVOIR STAND ASSEMBLY 12 3 5 SYSTEM CONNECTIONS QUICK GUIDE 15 3 6 POWER SUPPLY FOR THE CONTROL BOX 16 4 WORKING WITH...

Страница 4: ...CING THE SUBCUTANEOUS INJECTION INSERT 48 5 5 REPLACING THE ARM SKIN 49 5 6 REPLACING THE VEINS 52 6 TROUBLESHOOTING 54 6 1 GENERAL TROUBLESHOOTING 54 7 APPENDIX 55 7 1 REPLACEMENT PARTS LIST 55 7 2 G...

Страница 5: ...the Radial artery Brachial artery subcutaneous injection site on the the lateral side of the upper arm an intramuscular injection site in the deltoid area and a section of the humerus 1 2 SPECIFICATIO...

Страница 6: ...pate using fingernails as this may tear the skin palpate using the pads of the fingers Operating Temperatures Operating temperature 50 95 F 10 35 C Humidity 5 95 non condensing Storage Store the venou...

Страница 7: ...water then drain the vein reservoirs at the end of each day of simulation Doing so will retard the formation of mold and prevent clogging of the system The skin of the training arm can be cleaned wit...

Страница 8: ...ation Infusion Bolus Injection Blood draw collection Observe flashback Radial and brachial arterial puncture Cannulation Blood sampling collection Observe flashback IM injection Sub Q injection Humera...

Страница 9: ...ulation Infusion Bolus Injection Blood draw collection Observe flashback Radial and brachial arterial puncture Cannulation Blood sampling collection Observe flashback IM injection Humeral IO access an...

Страница 10: ...n a bed or clean flat surface 3 2 PACKAGE CONTENTS 1 Pediatric Patient Injection Training Arm 2 Arm Stand Assembly 3 Silicone Stand Cushion installed on Arm Stand 4 Blood dispensing bag 5 Blood Reserv...

Страница 11: ...05 100 S406 100 USER GUIDE Initial Setup 11 3 3 IDENTIFYING ARTERIAL AND VENOUS TUBING 1 Pump Inlet Tubing 2 Venous Drain Tubing 3 Vein Inlet Tubing 4 Artery Oulet Tubing 5 Pump Outlet Tubing 1 2 3 4...

Страница 12: ...sert both plastic blood stand brackets through the larger holes punched out on the blue metal base 3 Rotate the plastic blood stand brackets so the hollowed out groove is pointing towards the longer l...

Страница 13: ...ire frame into the hollowed out grooves on the plastic blood stand brackets NOTE It is helpful to brace your forefinger on the plastic blood stand brackets and use your thumb to push the blood stand w...

Страница 14: ...d arterial connection venous connection fill inlet drain outlet waste container NOTE The blood bag will hang from the metal knobs at thetop of the wire frame NOTE This diagram is based upon having the...

Страница 15: ...the power supply with power cord 2 Connect the power cord to the power supply 3 Plug the power cable into the control box and plug the other end into a wall outlet NOTE If necessary use one of the int...

Страница 16: ...ump outlet tubing It has one end with a white luer lock outlined in red and the other end is a black luer lock The second arterial tube is the artery outlet tubing It has one end with a black luer loc...

Страница 17: ...the port it is being connected to 5 Using the second arterial artery outlet tube connect and secure the black luer lock outlined in red to the black port outlined in red on the pediatric arm NOTE Matc...

Страница 18: ...twork They will be connected to corresponding ports on the pediartic arm that are also outlined in blue The first venous tube is the vein inlet tubing It has one end with a white luer lock outlined in...

Страница 19: ...blue to the corresponding port on the pediatric arm 4 Place the other end of this tube into a waste collection container NOTE Leave the tube unclamped Control Box Connection 1 Get the pump inlet tubin...

Страница 20: ...of the blood dispensing bag NOTE It is recommended to connect this end to the bottom left port on the blood dispensing bag NOTE Push the barb connector past its barb so that the bag does not leak when...

Страница 21: ...an assist in the mixing of this solution 2 Alternate between adding the Artificial Blood Plus Additive MIx powder and water in the jug Shake between each addition to aid dissolving of the powder NOTE...

Страница 22: ...ng smaller batches of the blood concentrate The size and weight of the water bottle also makes it easy to pour into the blood dispensing bag 2 Connect the barb connector end of the tube to the middle...

Страница 23: ...he instructions on the artifical blood concetrate bottle to mix with water It is easier to fill the blood dispensing bag when it is taken off the wire frame and filled NOTE The blood dispensing bag ca...

Страница 24: ...blood dispensing bag Priming the Pediatric Arm 1 Gather the fill syringe kit and prepared artificial blood concentrate NOTE The artifical blood shown here is already mixed with water 2 Assemble the fi...

Страница 25: ...Connect and secure the syringe to the white venous port outlined in blue on the pediatric arm 5 Push the syringe until the venous drain runs with blood and minimal air bubbles 6 Disconnect the syring...

Страница 26: ...in the waste collection container 2 Allow the artifical blood to run from the blood dispensing bag through this tube until the tube is completely filled and there are minimal air bubbles 3 Clamp the...

Страница 27: ...em Having any of the tubing clamped while turning the system ON to fill the system can increase pressure to the vasculature and potentially damage the control box if the pressure build up is too great...

Страница 28: ...nfusion 24 G Intradermal injection 26 G Intramuscular injection 20 23 G Humeral IO 15 mm Procedure Device Size Needle Stick 22 G or smaller Infusion of large amounts of fluid 18 22 G General infusion...

Страница 29: ...arm allow it to rest on its stand NOTE The ventral side of the S405 100 pediatric arm present the cephalic and basilic venous networks the median cubital vein and the radial artery for arterial blood...

Страница 30: ...ch in effect increases the pressure in the system s vasculature NOTE This will simulate bulging veins and or arteries for blood collection exercises 4 Twist the knob on the squeeze bulb of the pressur...

Страница 31: ...The subcutaneous site is for placement only It cannot hold or absorb large amounts of fluid The S406 100 pediatric arm does not have a subcutaneous injection site Locate the Intramuscular Injection Si...

Страница 32: ...rate NOTE The pulse rate can be set bewteen 12 180 bpm If a pulse rate of zero is desired turn off the control box 1 On the control box turn the Pulse Strength knob clockwise to increase or counter c...

Страница 33: ...e humerus of the pediatric arm using the appropriate medical equipment NOTE Recommended humeral IO needle is 15 mm for both the S405 100 and S406 100 3 Refer to section 5 Routine Maintenance on page 3...

Страница 34: ...IGURATION Disconnecting the Pediatric Arm 1 Gather the pediatric arm and the allen key hex 2 Rotate the pediatric arm to see the screw in the upper shoulder 3 Use the allen key hex to loosen the screw...

Страница 35: ...t NOTE Do not pull too hard If you do it may rip out the connections 6 Disconnect the tubing by pressing the orange part of the quick connector inward like a button and pulling the tube outward NOTE D...

Страница 36: ...connect by simply pushing the hose into the quick connector 2 Reconnect the green tube from the shoulder to the quick connector in the arm that is attached to a green tube Reconnect by simply pushing...

Страница 37: ...100 USER GUIDE Working with the Simulator 37 4 Twist the shoulder and arm halves so that they are secure 5 Tighten the screw in the shoulder with the allen hex wrench NOTE The arm is now ready for st...

Страница 38: ...diatric Arm Venous Network 1 Disconnect all tubing from the pediatric arm except the venous drain that has the black luer lock connection outlined in blue NOTE Leave the venous drain black luer lock c...

Страница 39: ...ge NOTE Do not mix alcohol into the distilled water Flush the veins with pure distilled water 3 Connect and secure the syringe to the white luer lock venous connection outlined in blue on the pediatri...

Страница 40: ...ure the syringe back to the white luer lock venous connection outlined in blue on the pediatric arm 7 Push the air through the venous network to purge any remaining fluid out through the drain 8 Dicon...

Страница 41: ...lushing the Pediatric Arm Arterial Network 2 Fill the syringe with distilled water NOTE Do not mix alcohol into the distilled water Flush the veins with pure distilled water 3 Connect and secure the s...

Страница 42: ...nge with air 6 Reconnect and secure the syringe to the white luer lock arterial port oulined in red on the pediatric arm 7 Push the air through the arterial network to purge any remaining fluid out th...

Страница 43: ...Dispensing Bag and Control Box 2 Remove the blood dispensing bag from the wire frame 3 Empty the remaining contents of the blood dispensing bag through the top right port on the bag into a waste colle...

Страница 44: ...leaning solution may already run through the tubes by itself 6 Turn ON the control box to clean the remaining tube 7 Allow the system to run until the tubing runs clear with distilled water 8 Disconne...

Страница 45: ...nnect it from the pediatric arm NOTE The humerus will have to be replaced after each puncture to prevent leaking when pressure is added to the venous network NOTE Use the pads of your fingers to remov...

Страница 46: ...unctured humerus by inserting the new humeral bone into the ports that were revealed 4 Replace the intramuscular insert by sliding the insert into the recess NOTE Push the intramuscular insert into it...

Страница 47: ...fully roll down the skin on the pediatric arm about a quarter of the way to reveal the upper lateral subcutaneous injection insert 1 Remove the intramuscular insert at the deltoid area of the pediatri...

Страница 48: ...LACING THE ARM SKIN 1 Roll the arm skin down starting at the end closest to the shoulder 2 Lift out the used subcutaneous injection insert and replace it with a new one 3 Hold the subcutaneous injecti...

Страница 49: ...to aid in rolling on the new skin 5 Fold the arm skin on itself to put over the hand of the arm NOTE Be careful not to grip the skin with fingernails as this may leave marks or tear the material Plac...

Страница 50: ...lide the rest of the skin up the arm NOTE This is the easy part NOTE Line up the the skin opening to fit over the ports on the pediatric arm NOTE Use the pads of your fingers to pinch and pull the ski...

Страница 51: ...pulling upwards and popping it off its white connector 3 Use the removed vein to measure out a length of new vein tubing and cut with a pair of scissors NOTE Do not pull too hard on the veins A minima...

Страница 52: ...NOTE Slide the new vein past the barb on the white connector until it is fully seated Secure all veins this way so that the system doesn t leak when filled 5 For veins that slip out of their designat...

Страница 53: ...outlet the power cable is plugged into is a working one There is no fluid flowing through the vasculature of the arm when the system is turned ON no fluid is exiting the drainage tubings The fluid flo...

Страница 54: ...ficial Blood Concentrate Kit Consumable 30081176A CMC Additive Consumable 11090012 Baby Powder Consumable 13082005A S405 100 IV Arm Shoulder Insert Light Consumable 13082032A S405 100 IV Arm Shoulder...

Страница 55: ...Reservoir Stand Assembly Replacement Part 14060059 Power Supply Desktop AC DC 12V 5A 60W Replacement Part 30070925B Pediatric AIV Arm Control Box Assembly Replacement Part 13090034D Sealed Bags New IT...

Страница 56: ...or to take possession or otherwise dispose of Products for which payment is overdue 4 Product Shipment and Risk of Loss Unless otherwise agreed to in writing by Gaumard all Products will be shipped F...

Страница 57: ...ge permit or the like Licenses even if applied for by Gaumard on Customer s beHAL f If any authorization is delayed denied revoked restricted or not renewed Gaumard sHAL l not be liable and Customer i...

Страница 58: ...y become due 2 a voluntary or involuntary bankruptcy proceeding is instituted by or against a Party hereto or 3 an appointment of a receiver or assignee for the benefit of creditors occurs on beHAL f...

Страница 59: ...to disclose or make available to other parties the Gaumard Software in source code format 2 8Certification Upon thirty 30 days written notice to End User from Gaumard End User sHAL l certify End User...

Страница 60: ...as FedEx or c when received if sent by certified or registered mail postage prepaid return receipt requested Any such notice given to a party sHAL l be sent to the addresses on the attached Purchase O...

Страница 61: ...d produced 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 compu...

Страница 62: ...to the simulator for possible troubleshooting as needed Technical Support Email support gaumard com USA 800 882 6655 INT 01 305 971 3790 7 6 GENERAL INFORMATION Sales and Customer Service E mail sale...

Отзывы: