I SEE THE BROADEST RANGE OF PRODUCTS THRU my smallest possible incision.*

Transcription

1 I SEE THE BROADEST RANGE OF PRODUCTS THRU my smallest possible incision.* Edwards ThruPort Systems The complete system for minimal incision valve surgery (MIVS) Prep Guide MIVS Redefined > THRUPORT SYSTEMS > TECHNOLOGY > TRAINING > SUPPORT *When compared to median sternotomy

2 Caution: This guide is for use in conjunction with full prescribing information supplied with the products. See package inserts for complete instructions and precautionary information. For all ThruPort sytems products, there are no Latex components in the packaging or in the product.

3 Table of Contents ProPlege Peripheral Retrograde Cardioplegia Device 2 EndoVent Pulmonary Catheter 4 IntraClude Intra-Aortic Occlusion Device 6 EndoClamp Aortic Catheter (65 cm) 10 EndoReturn Arterial Cannula 12 EndoDirect Arterial Cannula 14 Edwards Arterial Cannula 16 Edwards Introducer Sheath 18 Edwards Direct Arterial Cannula 20 QuickDraw Venous Cannula 22 1

4 ProPlege Peripheral Retrograde Cardioplegia Device (PR9) Description The ProPlege peripheral retrograde cardioplegia device is multifunctional, highly specialized device used during cardiopulmonary bypass to: - Deliver retrograde cardioplegia solution to the coronary sinus - Gently occlude the coronary sinus - Monitor the coronary sinus pressure Quick Facts Device specs: - Triple-lumen, 9 Fr shaft with elastomeric balloon near tip - Blue stopcock attached to the balloon lumen balloon inflation/ deflation (balloon contrast media must be diluted 1:6) - Green stopcock and central lumen retrograde cardioplegia delivery and guidewire access if needed - The white stopcock is attached to the coronary sinus pressure lumen - 59 cm working length with standard depth markers every 5 cm starting at 15 cm through 45 cm - Features a positioning dial that changes the curvature of the distal end of the device - Contamination guard system designed to avoid cross-contamination between the patient and the operating field Other kit components: - 11 Fr introducer sheath kit - 30 ml syringe for priming as well as contrast injection - 2 ml syringe for balloon inflation and deflation - Hemostasis valve adapter for guidewire placement Note: a guidewire is not provided in the kit; the ProPlege device can be used with a hy drophilic coated, soft tip.035-inch guidewire with a minimum length of 100 cm 2

5 Product Prep 1. Tighten the pre-assembled luer connections and remove all white caps to begin product preparation 2. Balloon inflation lumen: - Verify blue stopcock is turned off to the side port and attach the 2 ml volume syringe to the end port. Draw back syringe to remove air in balloon and lumen and turn stopcock off to the device. - Remove and fill the 2 ml volume syringe with sterile physiologic solution (further referred to as solution); reattach to stopcock - Point the open side port upwards, slowly inject up to.5 ml of solution until de-aired, attach white cap and turn the stopcock off to the side port - Hold the syringe vertically and slowly inject up to 1.4 ml of solution into the balloon. Slowly pull back to remove air from the balloon. Repeat until air has been removed. - Fully deflate the balloon, turn stopcock off to the device, remove syringe from the blue stopcock, wet fill the open port, reattach the syringe Warning: do not exceed maximum balloon inflation volume as balloon burst may occur Caution: If the balloon vacuum is lost, check the ProPlege device and accessories for leaks before inserting the ProPlege device. Failure to do so may result in unexpected balloon deflation and loss of occlusion. 3. Retrograde cardioplegia lumen/green stopcock: - Turn green stopcock off to the device and remove white cap from side port and contamination cap from the hose barb connector - Fill 30 ml syringe with solution and attach to open side port - Positioning hose barb adapter pointing up, inject solution until a continuous flow exits the hose barb adapter and recap it. Turn stopcock off to hose barb adapter. - Flush cardioplegia infusion lumen until solution comes out of tip and all air is removed. Turn green stopcock off to the device. - Remove the syringe, wet fill side port and reattach white cap 4. Coronary sinus pressure lumen/ white stopcock: - Remove white caps and turn stopcock off to device - Attach 30 ml syringe filled with solution to end port - Point open side port upwards, slowly inject solution through side port until de-aired, reattach white cap, and turn stopcock off to side port - Point tip of device downwards, flush solution through the lumen until all air is removed, turn white stopcock off to device - Remove the 30 ml syringe, wet fill end port and reattach white cap 5. The ProPlege peripheral retrograde cardioplegia device is now prepped and ready for use Warning: Any air left in the balloon or lumens may embolize 3

6 EndoVent Pulmonary Catheter (EV) Description Pre-shaped, peripherally placed catheter designed to vent from the pulmonary artery - Flexible catheter for percutaneous placement into the internal jugular vein (right) or subclavian vein (left) Quick Facts Catheter specs: - Double lumen, 8.3 Fr catheter with integrated balloon that allows catheter to be flow-directed into the pulmonary artery - Blue lumen (with one-way blue stopcock) balloon inflation - White lumen (with white stopcock) venting - Catheter is 60 cm long and has standard depth markings beginning at 10 cm - Contamination guard system for sterile catheter repositioning - Three-way stopcock allows for pulmonary artery pressure monitoring Other kit components: - 9 Fr introducer kit supplied ml syringe for balloon inflation - A vacuum relief valve is not supplied but is required for use 4

7 Product Prep 1. Remove white cap 2. Tighten all luer connections 3. Use the 1.5 ml syringe to fill balloon with air to verify balloon integrity Note: do not use saline to fill the balloon Warning: Never inflate balloon with liquid as this may cause an inability to fully inflate/deflate balloon Warning: Bacteria-filtered carbon dioxide should be used to inflate balloon in situations where balloon rupture may result in an air embolism in arterial circulation 4. Deair the balloon by drawing a vacuum twice with the syringe to fully deflate the balloon. Leave the syringe attached. 5. Using a 30 ml syringe: a. Flush the white lumen and attached pressure line with saline until all the air is displaced. Turn the stopcock off to the catheter tip. Cap the pressure line. b. Flush the catheter introducer sheath and single lumen infusion catheter to ensure patency and avoid introduction of air into the circulation 6. The catheter is now prepped and ready for placement Warning: Air left in any lumen may embolize during/after device insertion 5

8 IntraClude Intra-Aortic Occlusion Device (ICF100) Description Multifunctional, highly specialized device designed for use during cardiopulmonary bypass to provide atraumatic intra-aortic occlusion, deliver antegrade cardioplegia, vent the aortic root and monitor aortic root pressure Quick Facts Device specs: - Triple-lumen, 9 Fr device - Central lumen (with green stopcock) facilitates aortic root venting, delivery of antegrade cardioplegia, and guidewire placement - Red lumen (with red stopcock) pressure lumen to monitor aortic root pressure - Blue lumen (with blue stopcock) balloon lumen for balloon inflation/ deflation and monitoring pressure within the balloon cm in length with intra-aortic balloon near the device s distal tip - Designed for occluding aortas between cm - Shaft markings inform surgeon of the depth of device insertion - Blue ClampLock and suture loop/box clamp device allows shaft to be locked in place to help prevent balloon migration, once the aorta is occluded and final balloon placement is confirmed - Used in conjuction with the EndoReturn arterial cannula (ER21B, ER23B), the Edwards arterial cannula (AC19) or Edwards introducer sheath (IS19A) 6

9 Other kit components: - 35 ml syringe (for priming the IntraClude device as well as for inflating/ deflating the balloon) - 8 foot (244 cm) red pressure line (for aortic root pressure monitoring) - 8 foot (244 cm) blue pressure line (for balloon pressure monitoring) - Two additional white luer caps cm, inch (0.97 mm) J-tip guidewire 7

10 Product Prep 1. Tighten all pre-assembled luer connections. Verify all stopcocks are turned off to the capped side port. 2. To prep the blue balloon lumen, fill the 35mL syringe with 10 ml of sterile physiologic solution, de-air and connect to the open port of the blue stopcock Note: sterile physiologic solution will be referenced as solution in the remainder of this guide Warning: Do not fill IntraClude balloon with air as embolism may occur a. Hold the syringe vertically with the tip and IntraClude device tip pointing down to facilitate air removal through the de-airing hole at the proximal end of the balloon: i. Pull back the syringe plunger to remove air from the balloon and lumen ii. Depress the syringe plunger slowly and inject solution to inflate the balloon iii. Slowly pull back the syringe plunger to remove air from the balloon iv. Repeat steps until all air has been removed b. Once air removal has been confirmed, draw back the syringe plunger to fully deflate the balloon and turn off the stopcock to the device tip. Remove the syringe from the blue stopcock. 3. To prep the red root pressure lumen, fill the syringe with solution, de-air, and connect to the open port of the red stopcock a. Flush solution through the lumen until a continuous stream flows out the tip of the device b. Turn the stopcock off to the device tip and remove syringe from the red stopcock 4. Next load the supplied guidewire into the IntraClude device by first completely opening the rotating hemostasis valve (RHV) a. Load the J-tip of the guidewire into the straightener until the wire is flush with the straightener tip b. Gently position the straightener tip in the opening of the RHV and feed the guidewire into the IntraClude device until the tip of the guidewire is flush with the tip of the device 8

11 5. To prep the cardioplegia / root venting lumen, attach the syringe filled with solution to the side port and turn the green stopcock off to the Y-connector a. Flush solution continuously until fluid exits the RHV and no air bubbles exist. Continue flushing while closing the RHV. Note: Do not over tighten RHV to avoid damaging the guidewire. b. Next flush the lumen until a continuous stream of solution exits the device tip. Turn the green stopcock off to the device tip. c. Verify the three red, blue and white clamps on the Y-connector are open and hold the ends of the Y-connector upward to allow air to escape d. Flush the Y-connector, visually confirm the absence of air and close all three clamps e. Remove the syringe, wet fill the open port and attach a white cap 6. To prep the blue pressure monitoring line, attach the 8 foot blue pressure line to the open port on the blue stopcock a. Attach the filled syringe to the side port of the stopcock b. Flush until a continuous stream of solution exits the end of the pressure line and all visible air bubbles are removed c. Cap the end of the prepped pressure line d. Remove the syringe, wet fill the open port and attach a white cap 7. To prep the red pressure monitoring line, attach the 8 foot red pressure line to the open port on the red stopcock a. Attach the filled syringe to the side port of the stopcock b. Flush until a continuous stream of solution exits the end of the pressure line and all visible air bubbles are removed c. Cap the end of the prepped pressure line d. Remove the syringe, wet fill the open port and attach a white cap 8. The IntraClude intra-aortic occlusion device is now prepped and ready for use Warning: Air left in balloon or any lumen may embolize 9

12 EndoClamp Aortic Catheter (EC65) Description Multi-functional catheter designed for use in cardiopulmonary bypass to occlude the aorta, deliver antegrade cardioplegia, vent and monitor the aortic root Quick Facts Catheter specs: Fr triple lumen catheter - Central lumen (with green stopcock) facilitates aortic root venting and delivery of antegrade cardioplegia - White lumen (with white stopcock) pressure lumen to monitor aortic root pressure - Blue lumen (with blue stopcock) balloon lumen for balloon inflation/ deflation and monitoring pressure within the balloon - 65 cm in length with an elastomeric balloon at the tip - Balloon expands to occlude a range of aorta sizes (2.0 cm to 3.8 cm) - The blue ClampLock device, provided on the shaft, allows the catheter to be locked into place - The shaft is marked to indicate insertion depth - Used in conjunction with the EndoDirect arterial cannula (ED24A) Other kit components: - Red vacuum relief valve for use in the aortic root vent line 10

13 Product Prep 1. Remove and save pressure lines and white caps 2. Tighten all luer connectors 3. Prepare the balloon: a. Attach the blue 35 ml syringe to side opening on the blue stopcock and create a vacuum by drawing back on the syringe plunger twice b. Fill the 35 ml syringe with sterile saline and connect it to the blue stopcock Warning: Do not fill EndoClamp balloon with air as embolism may occur c. Slowly fill the balloon with approximately ml of sterile saline and turn blue stopcock off to the catheter tip d. Inspect balloon to verify proper inflation and balloon shape e. Gather any/all air bubbles into a single larger bubble and direct them toward the two black rings (holes) on the proximal edge of the balloon f. Turn the blue stopcock off to the port 180 from the catheter tip g. Position the tip of the catheter down and remove air bubbles through the two black deairing holes by injecting and aspirating the balloon. Repeat until balloon is fully deaired. Warning: Check the balloon at the end of your prep and prior to insertion to ensure that a vacuum has been maintained. Failure to do so may result in unexpected balloon deflation and loss of occlusion. 4. Refill and deair the syringe; wet flush the blue stopcock side port and attach the filled, deaired 35 ml syringe. The blue stopcock should be off toward the catheter tip. 5. Fill the green 35 ml syringe with sterile saline and attach it to the green stopcock 6. Turn green stopcock off to Y-connector. Inject saline into the green stopcock to flush the central lumen. Turn the green stopcock off toward catheter tip. 7. Flush saline past the red and blue tubing clamps, pinching them closed as each side of the Y-connector is deaired 8. Close the white tubing clamp and replace syringe on green stopcock with a white cap 9. Attach the 35 ml syringe to the side of the white stopcock and inject sterile saline into white stopcock and through the aortic root pressure lumen 10. Turn the white stopcock off to the catheter tip and replace the syringe with a white cap 11. Flush the red pressure line with saline and attach to end of white stopcock 12. Flush the blue pressure line with saline and attach to end of blue stopcock 13. All lumens should be flushed from the stopcock to the catheter tip and all stopcocks should be off to the catheter tip (balloon end of the catheter) 14. The catheter is now prepped and ready for use Note: balloon should be completely empty to ease insertion through the hemostasis valve Warning: Air left in balloon or any lumen may embolize. 11

14 EndoReturn Arterial Cannula (ER21B, ER23B) Description Unique cannula designed to deliver oxygenated blood for cardiopulmonary bypass while also allowing hemostatic introduction and removal of the IntraClude intra-aortic occlusion device (ICF100) - Used to cannulate the femoral artery for retrograde perfusion Quick Facts Cannula specs: - Wire wound cannula with a rotating hemostasis valve (RHV) - Two sizes available (21 Fr and 23 Fr) - Two non-reinforced clamp sites and a barbed connection for 3/8-inch tubing - Connector hub secures and immobilizes the introducer within the cannula for one person insertion of the cannula/introducer assembly - External lubricious coating to aid insertion into the femoral artery and an internal lubricious coating to aid in advancement of catheters and introducers Other kit components: - Introducer - Guidewire (0.038-inch, 100 cm, J-tip) - Connector hub 12

15 Product Prep 1. Wet cannula with saline to activate the lubricious coating 2. Insert the introducer into the cannula 3. Advance the introducer until the tip extends beyond the distal cannula tip and the alignment marker on the introducer aligns with the connector hub 4. Advance the connector hub on the introducer and over the barbed connector. This secures and immobilizes the introducer within the cannula. 5. Seal the hemostasis valve by turning the cap clockwise until tightens Arterial: Pressure Gradient vs. Flow* ER21B PRESSURE DROP (mmhg) ER23B FLOW RATE (l/min) * Mean value derived from in vitro testing performed with water at 23 C. The actual pressure gradients encountered in a clinical situation may vary from those shown, depending on perfusion techniques. 13

16 EndoDirect Arterial Cannula (ED24A) EndoDirect Arterial Cannula AutoIncisor introducer Description Unique cannula designed to deliver oxygenated blood for cardiopulmonary bypass while also allowing hemostatic introduction and removal of the EndoClamp aortic catheter (EC65) - Used to cannulate the aorta directly through a trocar or small incision for antegrade perfusion - Includes the AutoIncisor introducer for incising the aorta and introducing the cannula into the aorta Quick Facts Cannula specs: - Arterial cannula contains a beveled tip with an end hole, side perfusion holes, and a stabilizer ring with suture slots and tourniquet tubing posts - Wire wound cannula with rotating hemostasis valve (RHV) - Two non-reinforced clamp sites and a barbed connection for 3/8-inch tubing - Mark indicating tip orientation - Connector hub secures and immobilizes the introducer within the cannula for one person insertion of the cannula/introducer assembly - External lubricious coating to aid insertion into the aorta and an internal lubricious coating to aid in advancement of catheters and introducers Other kit components: - AutoIncisor introducer - Tourniquet tubing (tube style), set of two: 10.5 Fr, 7-inch (18 cm) length 14

17 Product Prep 1. Verify cannula is not damaged or kinked, the lumen is patent, and the RHV opens/closes completely 2. Remove the AutoIncisor introducer tip protector, slowly depress plunger and verify blade is visible when plunger is partially compressed 3. Fully depress plunger a second time until an audible click is heard to ensure the blade fully retracts 4. Seal the RHV by fully turning the cap clockwise 5. Wet the inner surface of the cannula and insert the AutoIncisor introducer through the straight arm of the Y-connector of the cannula Note: Ensure the plunger is not depressed as this may damage the cannula Warning: Do not wet AutoIncisor introducer to avoid entrapping air which could result in emboli 6. Secure the AutoIncisor introducer in place by pushing the connector hub over the barbed connection on the cannula and seat the hub against the introducer handle and the flange 7. Verify the tapered tip of the AutoIncisor introducer aligns with the end of the cannula tip 8. Deair lines in the usual fashion during initial use 9. Both products are now ready for use Arterial: Pressure Gradient vs. Flow* PRESSURE GRADIENT (mmhg) ED24A with EC65 (Balloon Inflated) ED24A with EC65 (Balloon Deflated) ED24A FLOW RATE (l/min) * Mean value derived from in vitro testing performed with water at 21 C. The actual pressure gradients encountered in a clinical situation may vary from those shown, depending on perfusion techniques. 15

18 Edwards Arterial Cannula (AC19) Description Cannula designed to deliver oxygenated blood during cardiopulmonary bypass during surgery - Used as a perfusion cannula to cannulate femoral arteries where 21 Fr or 23 Fr EndoReturn arterial cannula (ER21B, ER23B) will not work due to artery size Note: An introducer sheath (IS19A) in the other groin would be used to insert the IntraClude intra-aortic occlusion device Quick Facts Cannula specs: - Wire wound cannula with an atraumatic tip and a non-reinforced clamp site - 19 Fr size - The connector hub secures and immobilizes the introducer within the cannula for ease of insertion - Has an external lubricious coating for ease of insertion into the femoral artery and an internal lubricious coating for easy advancement of the introducer Other kit components: - Guidewire (0.038-inch, J-tip) - Introducer - Connector hub 16

19 Product Prep 1. Wet the cannula to activate the lubricious coating 2. Insert the introducer into the cannula and advance it until the introducer tip extends beyond the distal cannula tip and the alignment marker on the introducer aligns with the connector hub 3. Advance the connector hub over the introducer and over the barbed connector to secure the introducer within the cannula 4. The cannula is now prepped and ready for use Arterial: Pressure Gradient vs. Flow* PRESSURE GRADIENT (mmhg) AC FLOW RATE (l/min) * Mean value derived from in vitro testing performed with water at 23 C. The actual pressure gradients encountered in a clinical situation may vary from those shown, depending on perfusion techniques. 17

20 Edwards Introducer Sheath (IS19A) Description Designed for the hemostatic introduction and removal of the IntraClude intra-aortic occlusion device (ICF100) - Inserted in the femoral artery (a femoral arterial cannula (AC19) would be inserted in the other groin for arterial perfusion) Quick Facts Cannula specs: - Wire wound, 19 Fr cannula with an atraumatic tip and a non-reinforced clamp site - Rotating hemostasis valve (RHV) - Has an external and internal lubricious coating for ease of insertion in femoral artery and advancement of catheters Other kit components: - Guidewire (0.038-inch, J-tip) - Introducer 18

21 Product Prep 1. Wet the cannula to activate the lubricious coating 2. Open the RHV by rotating counter clockwise enough to insert the introducer 3. Insert the introducer into the cannula through the open RHV 4. Advance the introducer until the tip is visible outside the cannula tip and the alignment marker on the introducer aligns with the edge of the hemostatic valve 5. Seal the RHV by turning clockwise until it tightens 6. Product is now prepped and ready for use 19

22 Edwards Direct Arterial Cannula (SS23A, SS23S) Angled Straight AutoIncisor introducer Description Designed for direct aortic cannulation to deliver oxygenated blood for cardiopulmonary bypass - AutoIncisor introducer to incise the aorta and introducing the cannula into the aorta Quick Facts Cannula specs: - Wire wound, 23 Fr cannula with a non-reinforced clamp site - Features a fixed stabilizer ring with suture slots for purse-string placement - Barbed connection site for 3/8-inch tubing - Comes in an angled (SS23A) or straight (SS23S) tip versions - Black longitudinal line on angled tip cannula indicates tip orientation 20

23 Product Prep 1. Remove the AutoIncisor introducer tip protector, slowly depress plunger and verify blade is visible when plunger is partially compressed 2. Fully depress plunger a second time until an audible click is heard to ensure the blade fully retracts 3. Wet the inner surface of the cannula and insert the AutoIncisor introducer through the cannula Note: Ensure the plunger is not depressed as this may damage the cannula Warning: Do not wet AutoIncisor introducer to avoid entrapping air which could result in emboli 4. Secure the AutoIncisor introducer in place by pushing the connector hub over the barbed connection on the cannula and seat the hub against the introducer handle and the flange 5. Verify the tapered tip of the AutoIncisor introducer aligns with the end of the cannula tip 6. Deair lines in the usual fashion during initial use 7. Both products are now ready for use Arterial: Pressure Gradient vs. Flow* PRESSURE GRADIENT (mmhg) SS23S SS23A FLOW RATE (l/min) * Mean value derived from in vitro testing performed with water at 21 C. The actual pressure gradients encountered in a clinical situation may vary from those shown, depending on perfusion techniques. 21

24 QuickDraw Venous Cannula (QD22, QD25) Close up of tip Description Designed to drain non-oxygenated blood from the venae cavae or right atrium during cardiopulmonary bypass - Thin wall and wire wound design offers excellent flow characteristics Quick Facts Cannula specs: - Two sizes available (22 Fr and 25 Fr) - 65 cm in length with depth markings along the shaft - 3/8-inch barb connector connects to 3/8-inch tubing - Soft, clear tubing near connector allows visualization of air and blood, and provides non-reinforced clamp site - Blue connector hub secures the introducer within the cannula Other kit components: - 22 Fr includes one introducer; 25 Fr includes two introducers - Introducers are marked to simplify assembly and indicate alignment inch guidewire (180 cm, J-tip ) - Percutaneous insertion kit (3 dilators (8, 12, and 16 Fr), 18 gauge needle) - 5 ml syringe 22

25 QD22 Product Prep 1. Wet cannula and introducer with sterile saline 2. Insert introducer into the cannula 3. Position introducer alignment mark (black line) adjacent to the cannula connector hub (blue) 4. Advance introducer connector hub over the 3/8-inch connector on the cannula 5. The cannula is now prepped and ready for use QD25 Product Prep 1. Wet cannula and introducer with sterile saline 2. Insert inner introducer tip into the back of the outer introducer 3. Position alignment mark on the inner introducer adjacent to the back of outer introducer 4. Insert introducer assembly tip into the cannula 5. Position the alignment mark (black line) on the outer introducer adjacent to the hub (blue) 6. Advance introducer connector hub over the 3/8-inch barbed cannula connector 7. The cannula is now prepped and ready for use Caution: If the cannula kinks during preparation, do not use the device Venous: Pressure Gradient vs. Flow* PRESSURE GRADIENT (mmhg) QD22 QD25 FLOW RATE (l/min) * Mean value derived from in vitro testing performed with water at 21 C. The actual pressure gradients encountered in a clinical situation may vary from those shown, depending on perfusion techniques. 23

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28 Pressure/Flow/Volume Guidelines for MIVS Procedures System Subset For professional use. CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events. Edwards Lifesciences devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity. Edwards, Edwards Lifesciences, the stylized E logo, AutoIncisor, EndoClamp, EndoDirect, EndoReturn, EndoVent, IntraClude, ProPlege, QuickDraw, and ThruPort are trademarks of Edwards Lifesciences Edwards Lifesciences Corporation. All rights reserved. AR07992 Target Range Aortic Root = Systemic Pressure > 60 mmhg (during antegrade cardioplegia) Aortic Root Pressure 0 to 20 mmhg (during retrograde cardioplegia) Aortic Root Pressure 0 to 10 mmhg (during venting) Cardioplegic Solution Line Pressure < 400 mmhg Coronary Sinus Pressure 20 to 40 mmhg (during retrograde cardioplegia) ProPlege Peripheral Retrograde Cardioplegia Device Up to 1.4 ml Balloon Inflation Volume IntraClude Intra-Aortic Occlusion Device Balloon Up to 40 ml Inflation Volume EndoClamp Aortic Catheter Balloon Volume Up to 45 ml EndoVent Pulmonary Catheter Flow up to 250 ml/min (initial flow) EndoVent Pulmonary Catheter Flow < 40 ml/min (maintenance phase ) Mean Arterial Pressure (MAP) per hospital standard (standard) Myocardial Temperature < 20 C (per hospital standard) Venous Line Inlet Pressure -40 to -80 mmhg Relief Vacuum Valve Pop-off Pressure at EPV -60 to -115 mmhg Pump Speeds 0.25 to 2.0 l/min note: flow may be slightly increased during cardioplegic solution delivery. Inflation volumes in excess of 1 ml are unusual unless the coronary sinus appears to be abnormally large. Edwards Lifesciences I edwards.com USA I Switzerland I Japan I Singapore I Brazil