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Gaumard Sales Terms and Conditions | 57

S405.100 & S406.100

 | 

USER GUIDE

does not warrant that use of the Products will be uninterrupted or error-free, or that the Products will operate with non-Gaumard authorized third-
party products. THE FOREGOING WARRANTIES ARE IN LIEU OF AND EXCLUDE ALL  OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED 
BY OPERATION OF LAW OR OTHERWISE, INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR 
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 sHAL®l become Gaumard property. All claims sHAL®l 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 sHAL®l be barred from instituting any action thereafter. Customer sHAL®l 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 sHAL®l 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 SHAL®L 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 SHAL®L 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 beHAL®f. If any authorization is delayed, 
denied, revoked, restricted, or not renewed, Gaumard sHAL®l 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 sHAL®l 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 sHAL®l 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 sHAL®l 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 sHAL®l 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 sHAL®l 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.

Summary of Contents for S405.100

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 20 10 02 Gaumard Scientific Company...

Page 2: ......

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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