2010 Pyng Medical Corp. Pyng Medical Corp. www.pyng.com PM-079a This Trainers Manual is an essental component of the FASTx TM Sternal Intraosseous Device educaton program. It contains the guidelines and informaton needed to eectvely and e ciently teach emergency personnel how to perform sternal intraosseous (IO) infusion using the FASTx. Although the FASTx can be quickly and easily mastered, this is a SPECIALIZED MEDICAL PROCEDURE WHICH SHOULD NOT BE ATTEMPTED BY UNTRAINED PERSONNEL. Quality educaton is paramount to ensure users achieve the highest levels of competence and condence with this lifesaving device. Upon completon of training students will be able to: Discuss the principles of intraosseous infusion List indicatons and precautons for use of the FASTx Demonstrate safe and eectve use of the FASTx on a manikin and on training devices Explain and demonstrate the removal procedure for the FASTx Pyng Medical Corp. is commited to saving lives in seconds. Comments and suggestons for improvement of training and use of the FASTx are greatly appreciated. Pyng Medical Corp. 7-13511 Crestwood Place Richmond BC V6V 2E9 Canada Phone: 604-303-7964 1-800-349-7964 TRAINERS MANUAL Pyng Medical Corp. www.pyng.com PM-079a TABLE OF CONTENTS INTRODUCTION ................................................................................. 1 INTRAOSSEOUS INFUSION AND FASTx...............................................2 INDICATIONS AND PRECAUTIONS.......................................................5 DEMONSTRATION .............................................................................. 6 STEP-BY-STEP INSTRUCTIONS ............................................................ 7 SKILL PRACTICE TO MASTERY ............................................................ 9 REMOVAL ........................................................................................ 10 FASTx TRAINING DEVICE INSTRUCTIONS..........................................11 TROUBLESHOOTING ........................................................................ 16 FASTx SKILLS EVALUATION .............................................................. 18 FASTx WRITTEN EVALUATION ......................................................... 19 REFERENCES.....................................................................................23 FASTx LESSON PLAN Pyng Medical Corp. www.pyng.com PM-079a INTRODUCTION (5 minutes) 1. Introduce yourself and welcome students 2. Display course objectves: By the end of this session you will be able to: Discuss the principles of intraosseous infusion List indicatons and precautons for use of the FASTx Demonstrate safe and eectve use of the FASTx on a manikin and training device Explain and demonstrate the procedure for removal of the FASTx 3. Provide overview of training: Brief discussion of intraosseous infusion and FASTx device Demonstraton of FASTx (done in real-tme) Step-by-step instructon Skill practce to mastery Troubleshootng Evaluaton
1 Pyng Medical Corp. www.pyng.com PM-079a 1. Have students recall their most recent cardiac arrest patents (codes) or most recent atempt to secure vascular access on a trauma casualty, and then ask these questons: Were you able to establish a patent IV? How many atempts were required? How long did this process take? Were chest compressions interrupted to start the IV? Would your patents benet from a faster, more reliable procedure? Studies show it takes an average of 3-12 minutes to establish an IV with failure rates of 10-40% in the pre-hospital set ng. Transport is ofen delayed due to the di culty of insertng an IV in a moving vehicle. 2. Ask: Who is familiar with IO? Who has done IO before? How does IO work? Fluids and medicatons infused into the bone marrow are drained into the vascular/circulatory system Who has performed this Sternal IO procedure on a patent? Ask the student to share briey about the experience.
INTRAOSSEOUS INFUSION AND FASTx (10-15 minutes) 2 Pyng Medical Corp. www.pyng.com PM-079a 3. FASTx: Provides vascular access comparable to a central line The manubrium is the most eectve IO site (research shows uids and medicatons reach the heart in 20-30 seconds) due to its close proximity to the heart and immediate absorpton via internal mammary and azygos veins which empty directly into vena cava. Takes about 10 seconds to insert, less than 60 seconds for entre procedure Does not interfere with other procedures and can be used concurrently (compressions, cricothyroidotomy, etc.) The locaton of the manubrium inserton site high on the torso is ofen protected in trauma and military situatons, and allows for emergency care from a single area near the patents head Can be inserted while transportng the patent in moving vehicles Fluids and medicatons can be administered as you would for IV such as slow drip, boluses or pressure infuser Fluids and medicatons have been infused into sternums at 30ml/min by 1m gravity drip, 120ml/min by pressurized source and 250 ml/ min by syringe (infusion rates) Safe for patent (penetrates 6mm into the manubrium) and sta Is quick to learn and easy to retain 3 Pyng Medical Corp. www.pyng.com PM-079a 4. Pass around sample Infusion Tubes Note its exibility this allows it to move with patents skin which prevents it from dislodging Look at steel bone portal it will be inserted just inside marrow space Approximately 14 gauge inner diameter tubing Approximately 17 gauge inner diameter portal See page 3 for system infusion rates 5. Hold up Introducer Releases at a depth of 6 mm from the surface of manubrium to place in the marrow space Muscle-powered (not batery-dependent, spring-loaded or pneumatc) - Typically approximately 30 pounds into Simstern block - Compare to typical CPR at approximately 90 pounds - Actual force will vary depending on patent anatomy 4 Pyng Medical Corp. www.pyng.com PM-079a Establish a sternal Intraosseous access route for uids or drugs For patents 12 years of age and older (adolescent to adult) Use whenever vascular access is required to facilitate emergency resuscitaton Can be lef in place up to 24 hours
PRECAUTIONS/WARNINGS Trauma, infecton or burns at inserton site may preclude use Safety with very severe osteoporosis has not been proven Use in patents with recent sternotomy may prove less eectve The functon of the device may be aected by fracture of the sternum or vascular injury which may compromise the integrity of the manubrium or its vascularizaton Inserton in sites other than the manubrium may result in ineectve infusion and/or serious injury to the patent and are not approved Reuse of FASTx is not recommended due to the potental of cross-contaminaton, which may lead to serious injury or death. The FASTx is unlikely to functon afer use. INDICATIONS 5 Pyng Medical Corp. www.pyng.com PM-079a 1. Be sure the trainer, manikin and other equipment are ready for a speedy, awless procedure. Practce, practce, practce! 2. Invite someone to tme it. Ask students to hold their questons untl aferward. 3. Describe a real-life scenario with the manikin as your patent (ex1: Heres a 68 year-old male in cardiac arrest we need to give drugs Im going to use the FASTx.) (ex2: A 19 year-old male with bilateral lower extremity amputaton is in severe pain following tourniquet appli- caton, hemorrhage and breathing have been controlled and the airway is secure. There are no visible or pal- pable peripheral veins because of signicant blood loss. Im going to use the FASTx to secure vascular access.) 4. Perform procedure. 5. Ask if this appears to be superior to numerous IV atempts, interruptng CPR and/or delaying transport. DEMONSTRATION (Should be less than 1 minute) 6 Pyng Medical Corp. www.pyng.com PM-079a 1. Expose sternum and locate sternal notch. Tell students to place nger in the sternal notch. Have them pair up and do the same with their partner. This is the landmark its easy to nd on any patent. Thats where you place the Target Foot. 2. Clean inserton site. 3. Remove the Adhesive Liner with the Locking Pin. By pulling the Locking Pin o, the Adhesive Liner comes o too. 4. Stand at patents head or side, hold Introducer in dominant hand (or as comfortable). Align the Target Foot notch with the patents sternal notch. Point out that this is over the midline and perpendicular to the manubrium. Hold Introducer perpendicular to manubrium and PAUSE. Consider the angle of the manubrium. This positon ensures the Infusion Tube tp will be inserted correctly. Give everyone an opportunity to see what perpendicular to the manubrium looks like and also model NOT perpendicular. STEP-BY-STEP INSTRUCTIONS (5-10 minutes) 7 Pyng Medical Corp. www.pyng.com PM-079a 5. Press down completely with increasing force untl you hear and feel Infusion Tube separate from Introducer. Hold this positon while you ask a couple of students to describe the pressure you just used. Note: The force used will be less with the FASTx than with the FAST1 (for those with experience with the FAST1). Please see step 5 on page 4. Reinforce that it was smooth and steady. Dont stab, jab or twist just push untl it releases. 6. Withdraw the FASTx Sternal straight back while holding down the Target Foot. Support comes out with the Infusion Tube. Discard the FASTx Sternal following local contaminated sharps protocols.
7. Connect the IV line, or source of uid or medicaton, directly to the luer. Clip the Strain Relief Hook on the Infusion Tube luer, to the Target Foot clip. Opton: (refer to your protocol) Flush with uid to clear Conrm placement by aspiraton 8. Remove the liner from the Protectve Dome and apply the Dome over the Target Foot Infusion Site. Use of the FASTx Dome is optonal as the Target Foot also provides protecton. 8 Pyng Medical Corp. www.pyng.com PM-079a Most medical providers will only need one or two trials to be totally competent and condent however, since everyone achieves mastery of psychomotor skills at a dierent rate, be sure to plan for and allow plenty of tme with this secton. Remember, once a medical provider feels comfortable with the FASTx, he/she is more likely to utlize it. HANDY TEACHING HINT: Put the students who nish rst to work: they can quickly be taught to reset the trainer, turn the manikins disk, etc., which frees you up to work more closely with anyone who requires more instructon. Reassure those who are struggling that, I needed to practce that a few tmes too. SKILL PRACTICE TO MASTERY (Time variable) 9 Pyng Medical Corp. www.pyng.com PM-079a Students are taught how to remove the FASTx because theres a strong possibility the hospital sta may request assistance (or just reassurance) with the procedure. 1. Remove Protectve Dome from Target Foot. 2. Turn o the source of uid and medicaton and disconnect IV tubing. 3. Grasp Infusion Tube with ngers or clamp and pull perpendicular to the manubrium untl entre Infusion Tube (including metal tp) emerges from the patents chest. Note: pull in one contnuous moton (do not start/ stop) untl removed. Use the tube to pull, not the luer connecton. It is normal for the tubing to stretch. 4. Peel o the Target Foot and dress the site as per standard protocol. 5. Discard Infusion Tube and Target Foot following local contaminated sharps protocol.
REMOVAL of FASTx 10 Pyng Medical Corp. www.pyng.com PM-079a DEPLOYMENT 1. Remove the red Locking Pin from the Handle of the FASTx Training Device. Note: The FASTx Training Device does not have the Adhesive Liner on the Target Foot. 2. Place the FASTx Training Device on a Simstern block (yellow foam with plastc over white foam). 3. Ensure to push down completely to deploy the FASTx Training Device into the Simstern block. FASTx TRAINING DEVICE INSTRUCTIONS 11 Pyng Medical Corp. www.pyng.com PM-079a 4. Pull the FASTx Training Device straight back while holding down the Target Foot to separate the Handle from the Infusion tube, which is now inserted into the Simstern bone. 5. Connect the luer to the IV line or source of uid or medicaton. Connect the Infusion Tube Strain Relief Hook to the Target Foot. 6. Place the Dome over the Target Foot. Note: Use of the FASTx Dome is optonal as the Target Foot also provides protecton. 12 Pyng Medical Corp. www.pyng.com PM-079a 7. To remove, grip as close to the lower end of the Infusion Tube as possible. Pull the Infusion Tube out from the Simstern bone. Note: Pull in one contnuous moton (do not start/ stop) untl removed. Use the tube to pull, not the luer connecton. It is normal for the tubing to stretch. RESETTING THE FASTx TRAINING DEVICE 1. Reset the FASTx Training Device using the Reset Tool. Push the Reset Tool into the hole in the back of the FASTx Handle. Push gently untl you hear and feel a click. Note: You do not need to push hard to reset the FASTx Training Device. 2. Carefully push down on the Needle Cover, and hold it down with your thumb and/or ngers to prepare for the next step. REMOVAL 13 Pyng Medical Corp. www.pyng.com PM-079a 3. While holding down the Needle Cover, load the Infusion Tube over the Stylet. Note: Load the Infusion Tube with the Strain Relief Hook towards the side of the Handle (90 degrees from the FASTx logo). 4. Load the blue Ant-Buckle into the slot next to the Stylet with Infusion Tube. Ensure to snap the Ant-Buckle into place. 5. Snap the Target Foot back on the Needle Cover. Ensure that the Target Foot notch is aligned with the Handle notch. 6. Check alignment of the Target Foot on the Needle Cover. Ensure each needle is in its respectve separate hole. (If not, repeat step 5.) Pull Needle Cover back out in place. 14 Pyng Medical Corp. www.pyng.com PM-079a 7. Snap the red Locking Pin back in the Handle. 8. The FASTx Training Device is now ready for re-use. Note: The FASTx Training Device needles will get worn with re-use and the device may need to be replaced. The Infusion Tube will stretch afer multple uses and may need to be replaced. 15 Pyng Medical Corp. www.pyng.com PM-079a 1. Fluid or medicaton does not ow through IV line to site. Flush to clear. If uid or medicaton does not ow even afer ushing, infusion should be discontnued and an alternatve method of vascular access should be used. 2. Leakage at Inserton Site (Extravasaton). If excessive, use alternatve method of vascular access. 3. First atempt to place FASTx fails. Double check inserton site, patent positon, medic positon, and try again with a new device. Be sure to re- mind students to save a device if the procedure/atempt with the FASTx was not successful (afer protectng the sharps) for shipment back to Pyng for examinaton. 4. Removing entre Infusion Tube Pull perpendicular to the manubrium untl the entre Infusion Tube (including metal tp) emerges from the patents chest. Ensure to pull in one smooth contnuous moton (do not start/stop) untl removed. Use the tube to pull, not the leur connecton. It is normal for the tubing to stretch.
5. Introducer does not release. Pull Introducer back, if Infusion Tube remains in patent, verify placement by aspiratng marrow, proceed with use. If marrow cannot be withdrawn, remove tube and insert second FASTx. TROUBLESHOOTING 16 Pyng Medical Corp. www.pyng.com PM-079a 6. Introducer releases but Infusion Tube is not secured in patent. Use new FASTx. 7. Force is applied but Introducer does not release. Without pulling back, ensure Introducer is perpendicular to manubrium and force is being applied directly along this line. TROUBLESHOOTING 17 Pyng Medical Corp. www.pyng.com PM-079a 1. Expose Sternum and locate Sternal Notch 2. Clean inserton site 3. Remove Adhesive Liner and Locking Pin 4. Stand at patents head or side, hold Introducer in dominant hand (or as comfortable) 5. Align Target Foot with patents Sternal Notch 6. Press down completely with increasing force untl Infu- sion Tube separates from Introducer
7. Withdraw FASTx straight back while holding down the Target Foot 9. Discard the FASTx following local contaminated sharps protocols 10. Connect the source of infusion to the luer 11. Clip the Strain Relief Hook on the Infusion Tube luer to the Target Foot clip 12. Remove liner from Protectve Dome and apply Dome over the Target Foot Infusion Site (use of the FASTx Dome is optonal) FASTx SKILLS EVALUATION 18 Pyng Medical Corp. www.pyng.com PM-079a 1. Precautons/Warnings for the FASTx include: a) previous sternotomy b) compromised skin over site c) severe osteoporosis d) all of the above 2. The landmark for the Target Foot is the: a) xiphoid process b) sternal notch c) subclavian ridge d) Angle of Louis 3. Preparaton of the site should include: a) sterile draping b) wash with soap and water c) maintain aseptc technique throughout the procedure d) no preparaton is recommended 4. Approved sites for the FASTx include: a) manubrium of sternum b) medial tbia c) proximal humerus d) none of the above FASTx WRITTEN EVALUATION 19 Pyng Medical Corp. www.pyng.com PM-079a 5. Proper placement of the Infusion Tube can be ensured by holding the Introducer: a) at a 45-degree angle to the oor b) perpendicular to the manubrium c) vertcal to the body of the sternum d) aimed toward the heart 6. The Introducer is powered by: a) pneumatc force b) bateries c) springs d) muscles 7. How should force be applied to the Introducer? a) with a quick thrust b) smooth, increasing untl release c) steady, decreasing for 5 seconds d) any of the above is acceptable 8. The FASTx can be lef in place for: a) 24 hours b) 1 hour c) only untl the patent is stabilized d) 48 hours 9. Which of these can be delivered through the FASTx? a) epinephrine b) blood and blood products c) normal saline or Ringers Lactate d) all of the above 20 Pyng Medical Corp. www.pyng.com PM-079a 1. Precautons for the FASTx include: a) previous sternotomy b) Compromised skin over site c) severe osteoporosis d) all of the above 2. The landmark for the Target Foot is the: a) xiphoid process b) sternal notch c) subclavian ridge d) Angle of Louis 3. Preparaton of the site should include: a) sterile draping b) wash with soap and water c) maintain aseptc technique throughout the procedure d) no preparaton is recommended 4. Approved sites for the FASTx include: a) manubrium of sternum b) medial tbia c) proximal humerus d) none of the above ANSWER KEY
21 Pyng Medical Corp. www.pyng.com PM-079a 5. Proper placement of the Infusion Tube can be ensured by holding the Introducer: a) at a 45-degree angle to the oor b) perpendicular to the manubrium c) vertcal to the body of the sternum d) aimed toward the heart 6. The Introducer is powered by: a) pneumatc force b) bateries c) springs d) muscles 7. How should force be applied to the Introducer? a) with a quick thrust b) smooth, increasing untl release c) steady, decreasing for 5 seconds d) any of the above is acceptable 8. The FASTx can be lef in place for: a) 24 hours b) 1 hour c) only untl the patent is stabilized d) 48 hours 9. Which of these can be delivered through the FASTx? a) epinephrine b) blood and blood products c) normal saline or Ringers Lactate d) all of the above 22 Pyng Medical Corp. www.pyng.com PM-079a Macnab, Andrew, Christenson, Jim, Findlay, Judy, Horwood, Bruce, Johnson, David, Jones, Lanny, Phillips, Kelly, Pol- lack, Charles, Robinson, David J., Rumball, Chris, Stair, Tom, Tiany, Brian and Whelan, Max : A new system for sternal intraosseous infusion in adults. Prehospital Emergency Care, 4:2, 173-177. Findlay J, Johnson DL, Macnab AJ, MacDonald D, Shellborn R, Susak L: Paramedic evaluaton of an adult intraosseous infusion system. Prehospital and Disaster Medicine 2006; 21(5), 329335. David L Johnson; Judy Findlay; Andrew J Macnab; Lark Susak: Cadaver testng to validate design criteria of an adult intraosseous infusion system. Military Medicine, March 2005; 170, 3; ProQuest Medical Library, 251-257. Tsitlik JE et al: Elastc Propertes of the Human Chest During Cardiopulmonary Resuscitaton. Critcal Care Medicine 1983; 11(9):685-692. REFERENCES 23