Verify Flow over a Wide Dynamic Range with Non-invasive Sensor •
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Verify Flow over a Wide Dynamic Range with Non-invasive Sensor •
CP Bypass/ECMO Verify Flow over a Wide Dynamic Range with Non-invasive Sensor • Measures blood, saline or cardioplegia • Bidirectional measurement • Stable, low-flow measurement CP Bypass/ECMO Verify Pump & ECMO Circuit Flows for Critical Safety & Quality Assurance Transonic® Clamp-on Tubing Flowsensors complement the Transonic® HT110 Tubing Flowmeter to provide an independent measure of actual delivered blood flow. The system provides noninvasive, sterile measurements without any contact with the fluid or interruption of tubing. It has a stable and low zero offset and its calibration can be adjusted on site. Measurements are stable at the low flows used in ECMO treatment. The Transonic® HT110 Tubing Flowsensor/ Flowmeter system is the “Gold Standard” used throughout the biomedical industry with which they calibrate & validate other heart/ lung pumps. “Use of the Transonic Flowmeter allows the ECMO specialist to monitor actual patient blood flow and hemofilter shunt enhancing patient care management” Berube, MC 12th Annual CNMC Symposium on ECMO & Advanced Therapies for Respiratory Failure, Keystone, CO, Feb 25-29, 1996. “Using the Transonic Flowmeter, a pre determined (partially occlusive) setting can be achieved by first determining the point of total occlusion, then decreasing occlusion a small percentage from this maximum (i.e., total) occlusion. Clinical application in 35 neonatal ECMO cases has shown the practice to be safe, reliable, and efficient.” Synder, E ASAIO J 1997; 43: 60-64. • Maintains Tubing Integrity • Sensor Clips onto Existing Tubing • Unmatched Accuracy ± 10% TRANSIT-TIME ULTRASOUND TECHNOLOGY CLAMP-ON TUBING FLOWSENSOR Transonic® XL-Series Flowsensors are re-usable; factory-calibrated for specific tubing size, material, fluid and temperature, and available for 1/8” to 1 1/4” OD Tubing (3.2 mm OD to 31.8 mm OD). Four transducers pass ultrasonic signals, alternately intersecting the vessel in upstream and downstream directions. The difference between the four transit times yields a measure of volume flow. Transonic Systems Inc. is a global manufacturer of innovative biomedical measurement equipment. Founded in 1983, Transonic sells “gold standard” transit-time ultrasound flowmeters and monitors for surgical, hemodialysis, pediatric critical care, perfusion, interventional radiology and research applications. In addition, Transonic provides pressure and pressure volume systems, laser Doppler flowmeters and telemetry systems. www.transonic.com AMERICAS EUROPE ASIA/PACIFIC JAPAN Transonic Systems Inc. 34 Dutch Mill Rd Ithaca, NY 14850 U.S.A. Tel: +1 607-257-5300 Fax: +1 607-257-7256 [email protected] Transonic Europe B.V. Business Park Stein 205 6181 MB Elsloo The Netherlands Tel: +31 43-407-7200 Fax: +31 43-407-7201 [email protected] Transonic Asia Inc. 6F-3 No 5 Hangsiang Rd Dayuan, Taoyuan County 33747 Taiwan, R.O.C. Tel: +886 3399-5806 Fax: +886 3399-5805 [email protected] Transonic Japan Inc. KS Bldg 201, 735-4 Kita-Akitsu Tokorozawa Saitama 359-0038 Japan Tel: +81 4-2946-8541 Fax: +81 4-2946-8542 [email protected] ExtracorporealCover(EC-100-fly-A4)RevB 2015 CP Bypass/ECMO HT110 Bypass Flowmeter The Transonic HT110 Bypass Flowmeter system measures volume flow rates of blood or perfusate in extracorporeal circuits. It provides non-invasive volume flow measurement over a wide dynamic range. Measurement accuracy and resolution are unmatched. An external clamp-on Flowsensor clips onto the tubing to continuously monitor actual flow delivery to the patient. Measurements are non-invasive, continuous bi-directional. The Flowmeter/Flowsensor system • Displays actual volume flow in mL or L/min • Measures blood, saline, and cardioplegia • Maintains sterility of liquids • Custom sensor calibration is available for different fluids and temperatures combinations • Easily customized for specialized applications HT110 Bypass Flowmeter Ensure Optimal Perfusion to Provide Proactive Patient Management H-XL Tubing Flowsensors Transonic® Clamp-on Tubing Sensors use unique ultrasonic transit time technology to measure volume flow with highest accuracy. Most fluids can be measured including saline, cardioplegia, and blood. No physical contact is made with the fluid media. HXL-Series Flowsensors can be calibrated and programmed for up to 4 different fluid / temperature / tubing combinations and will work with most flexible tubing types. Sensor size is determined by outside diameter of the tubing. Flowsensor on Tubing Choosing Your Flowsensor Size Sensors are scaled in 1/16 inch increments to clamp around standard tubing diameters. Tubing CLAMP-ON FLOWSENSOR SIZES H3XL 3/16 1/8 x 1/32 5 mm -M5 Flexible medical grade and laboratory tubings (PVC, silicon, polyurethane) are generally compatible for use with -XL Sensors. A 30 - 60 cm tubing sample is required to calibrate the Sensor. H4XL 1/4 1/8 x 1/16 6 mm -M6 Optional H5XL 5/16 3/16 x 1/16 8 mm -M8 H6XL 3/8 1/4 x 1/16 9 mm -M9 TUBING SENSOR # OD (inches) ID X WALL (inches) OD (metric) (metric tubes) H2XL 1/8 x 5/32 3/32 x 1/32 4 mm -M4 Cat # Suffix H7XL 7/16 1/4 x 3/32 10 mm -M10 H8XL 1/2 3/8 x 1/16 12 mm -M12 H9XL 9/16 3/8 x 3/32 14 mm -M14 H10XL 5/8 1/2 x 1/16 16 mm -M16 H11XL 11/16 1/2 x 3/32 - - H12XL 3/4 1/2 x 1/8 20 mm -M20 HT110Datasheet(EC-101-ds)RevC2015A4 Sensors are calibrated for specific tubing densities and temperature. The HT110s have the capability to specify, when ordering, up to four tubing, fluid, temperature, and flow rate combinations. Fluid samples and MSDS information are required for custom calibration requests. www.transonic.com CP Bypass/ECMO Flow Verification during ECMO with Transit-time Ultrasound Technology THEORY & METHODOLOGY Drost CJ, “Volume Flow Measurement System,” U.S. Patent # 4,227,407, Cornell Research Foundation, Inc., Ithaca NY, October 14, 1980. (Transonic Reference # 1T) Drost CJ “Homogeneous Full Flow Illumination to Ultrasonic Systems,” Proceedings of the 31st Annual Conference of Engineering in Medicine and Biology, Bethesda MD: Alliance for Engineering in Medicine and Biology 1978; 20: 183. (Transonic Reference # 2T) Drost CJ, “Vessel Diameter-Independent Volume Flow Measurements Using Ultrasound,” Proceedings of San Diego Biomed. Symposium, San Diego CA: San Diego Biomed. Soc. 1978; 17: 299-302, 1978. (Transonic Reference # 3T) Hemisch W, “Blood Flow during Cardiovascular Surgery: Methodological, Technical and Practical Considerations,” Gefäßchirugie, Springer-Verlag, 1996. (Transonic Reference # 4T) PUBLICATIONS Labuz M, Huckaby J, Pettigano R, Heard M, Kesser K, Clark R, Children’s Hospital, Emory University, Atlanta, GA 7th Int’l ELSO Conference, Dearborn, MI, 1995. (Transonic Reference # E7376R) Akers T, Bolen G, Gomez J, Hodgson-Smith A, Merrill, J Anderson G, Huddleson J, Moretz T, Kirvan K, Kirvan D, Sutton RG, Riley JB, “In Vitro Comparison of ECC Blood Flow Measurement Techniques,” Proceedings Am Soc of Extracorporeal Technol 1990; 17-22. (Transonic Reference # 28V) Berube MC, Brink LW, “Ultrafiltration in the Cardiac ECMO Patient: Use of the Transonic HT109 Flowmeter to Determine Hemofilter Shunt and Actual Flow,” 12th Annual CNMC Symposium on ECMO & Advanced Therapies for Respiratory Failure, Keystone, CO, February 25-29, 1996. (Transonic Reference # 715A) Gray BW, Haft JW, Hirsch JC, Annich GM, Hirschl RB, Bartlett RH “Extracorporeal life support: experience with 2,000 patients.” ASAIO J. 2015 Jan-Feb;61(1):2-7. (Transonic Reference # 10210AH) Wiktor AJ1, Haft JW, Bartlett RH, Park PK, Raghavendran K, Napolitano LM, “Prolonged VV ECMO (265 days) for ARDS Without Technical Complications,” ASAIO J. 2014 Nov 24 (Transonic Reference # 10211AH) Bartlett RH, Combes A, Peek GJ, “Extracorporeal life support,” Ann Am Thorac Soc. 2014 Jul;11(6):992. (Transonic Reference # 10212AHR). Lequier L, Horton SB, McMullan DM, Bartlett RH, “Extracorporeal membrane oxygenation circuitry,” Pediatr Crit Care Med. 2013 Jun;14(5 Suppl 1):S7-12. (Transonic Reference # 10216R) Spurlock DJ, Koch K, Mazur DE, Fracz EM, Bartlett RH, Haft JW, “ Preliminary in vivo testing of a novel pump for short-term extracorporeal life support,” Ann Thorac Surg. 2012 Jan;93(1): Transonic Reference # 10217A) Macha M, Litwak P, Yamazaki K, Kameneva M, Butler KC, Thomas DC, Taylor LP, Griffith BP, Borovetz HS, “In Vivo Evaluation of an Extracorporeal Pediatric Centrifugal Blood Pump,” ASAIO J 1997; 43: 284-288. (Transonic Reference # 951A) MacLaren G, Combes A, Bartlett RH, “Contemporary extracorporeal membrane oxygenation for adult respiratory failure: life support in the new era,” Intensive Care Med. 2012; 38(2): 210-20. (Transonic Reference # 10218R) Tamari Y, Lee-SensibaK, Leonard EF, Tortolani AJ, “A Dynamic Method for Setting Roller Pumps Nonocclusively Reduces Hemolysis and Predicts Retrograde Flow,” ASAIO J 1997; 43: 39 - 52. (Transonic Reference # 841A) Park PK, Napolitano LM, Bartlett RH, “Extracorporeal membrane oxygenation in adult acute respiratory distress syndrome,” Crit Care Clin. 2011l; 27(3): 627-46. (Transonic Reference # 10219R) Lönn U, Wulff J, Keck K-Y, Wranne B, Ask P, Peterzén C-A H, “Flow Characteristics of the Hemopump: An Experimental In Vitro Study,” Annals of Thorac Surg 1997; 63: 162-166. (Transonic Reference # 828A) ECMOReferences(EC-50-ref)RevA2015A4 www.transonic.com CP Bypass/ECMO Verify Flow in ECMO Circuits & Ensure Optimal Flow Delivery The Transonic® Tubing Flowmeter and Clamp-on Tubing Flowsensor has multiple uses during ECMO. They include: 1. Facilitation of roller pump occlusion setting before starting an ECMO run. 2. Confirmation of actual flow delivery to the patient 3. Helping to maintain secondary venous drainage catheter patency for duration of the ECMO Run 4. Secondary bubble detection SET ROLLER PUMP OCCLUSION The pump output can be calibrated against the Flowmeter to ensure an accurate occlusion setting. One advantage of using the Tubing Flowsensor instead of a timed collection is that the fluid-filled circuit does not have to be open to air. CONFIRMATION OF ACTUAL FLOW DELIVERY DURING ECMO RUNS A Transonic® Flowsensor on the arterial inlet cannula confirms actual flow delivery to the patient when a hemofilter is used. The hemofilter can siphon off up to 250 mL/min (ECMO flow rates are typically 500 mlL/min). By measuring flow rates downstream from the shunt, the clinician can increase the pump speed to maintain the desired level of perfusion. The Flowsensor also provides an early warning if the shunt starts to clot off. (Shunt flow can be calculated by subtracting the flowsensor reading from pump output). If the shunt clots off, the patient will be over perfused, as total pump output will be directed to the patient. Over perfusion is a greater clinical concern than under perfusion, which can be monitored from SVO2 levels. ECMOMedical Note(EC-1-mn)RevC2013A4 ASSISTS IN MAINTAINING SECONDARY MONITOR VENOUS DRAINAGE AND CATHETER PATENCY IN V-V ECMO Some ECMO groups use a cephalad cannula in V-V ECMO to improve oxygen delivery. Cephalad cannula flow rates can vary depending on the size of the patient and perfusion rates. For example, if the flow in the venous cannula was 300 mL/min and suddenly dropped to 150 mL/min, the clinician would check the cannula and reposition the patient to restore flow. By using the Transonic® Flowsensor to measure actual flow, venous catheters can be kept patent for the duration of extended ECMO runs. SECONDARY BUBBLE DETECTION A macro air embolus occurs rarely as a result of a catastrophic failure such as tubing rupture. Some ECMO centers have purchased the equipment for its bubble detection capability. Many ECMO centers use the Stockert-Shiley pump with a builtin bubble detection option that triggers an automatic pump shut-off. However, others are not using any air bubble detector. SUMMARY • Set pump occlusion • Monitor arterial delivery throughout long ECMO runs • Monitor patency of venous catheter www.transonic.com CP Bypass/ECMO Verify Flow in ECMO Circuits cont. REFERENCES Labuz M, Huckaby J, Pettigano R, Heard M, Kesser K, Clark R, Children’s Hospital, Emory University, Atlanta, GA 7th Int’l ELSO Conference, Dearborn, MI, 1995. (Transonic Reference # E7376R) Gray BW, Haft JW, Hirsch JC, Annich GM, Hirschl RB, Bartlett RH “Extracorporeal life support: experience with 2,000 patients.” ASAIO J. 2015 Jan-Feb;61(1):2-7. (Transonic Reference # 10210AH) Akers T, Bolen G, Gomez J, Hodgson-Smith A, Merrill, J Anderson G, Huddleson J, Moretz T, Kirvan K, Kirvan D, Sutton RG, Riley JB, “In Vitro Comparison of ECC Blood Flow Measurement Techniques,” Proceedings Am Soc of Extracorporeal Technol 1990; 17-22. (Transonic Reference # 28V) Wiktor AJ1, Haft JW, Bartlett RH, Park PK, Raghavendran K, Napolitano LM, “Prolonged VV ECMO (265 days) for ARDS Without Technical Complications,” ASAIO J. 2014 Nov 24 (Transonic Reference # 10211AH) Macha M, Litwak P, Yamazaki K, Kameneva M, Butler KC, Thomas DC, Taylor LP, Griffith BP, Borovetz HS, “In Vivo Evaluation of an Extracorporeal Pediatric Centrifugal Blood Pump,” ASAIO J 1997; 43: 284-288. (Transonic Reference # 951A) Tamari Y, Lee-SensibaK, Leonard EF, Tortolani AJ, “A Dynamic Method for Setting Roller Pumps Nonocclusively Reduces Hemolysis and Predicts Retrograde Flow,” ASAIO J 1997; 43: 39 - 52. (Transonic Reference # 841A) Lönn U, Wulff J, Keck K-Y, Wranne B, Ask P, Peterzén C-A H, “Flow Characteristics of the Hemopump: An Experimental In Vitro Study,” Annals of Thorac Surg 1997; 63: 162166. (Transonic Reference # 828A) Berube MC, Brink LW, “Ultrafiltration in the Cardiac ECMO Patient: Use of the Transonic HT109 Flowmeter to Determine Hemofilter Shunt and Actual Flow,” 12th Annual CNMC Symposium on ECMO & Advanced Therapies for Respiratory Failure, Keystone, CO, February 25-29, 1996. (Transonic Reference # 715A) www.transonic.com Bartlett RH, Combes A, Peek GJ, “Extracorporeal life support,” Ann Am Thorac Soc. 2014 Jul;11(6):992. (Transonic Reference # 10212AHR). Lequier L, Horton SB, McMullan DM, Bartlett RH, “Extracorporeal membrane oxygenation circuitry,” Pediatr Crit Care Med. 2013 Jun;14(5 Suppl 1):S7-12. (Transonic Reference # 10216R) Spurlock DJ, Koch K, Mazur DE, Fracz EM, Bartlett RH, Haft JW, “ Preliminary in vivo testing of a novel pump for short-term extracorporeal life support,” Ann Thorac Surg. 2012 Jan;93(1): Transonic Reference # 10217A) MacLaren G, Combes A, Bartlett RH, “Contemporary extracorporeal membrane oxygenation for adult respiratory failure: life support in the new era,” Intensive Care Med. 2012; 38(2): 210-20. (Transonic Reference # 10218R) Park PK, Napolitano LM, Bartlett RH, “Extracorporeal membrane oxygenation in adult acute respiratory distress syndrome,” Crit Care Clin. 2011l; 27(3): 627-46. (Transonic Reference # 10219R) Transonic Systems Inc. is a global manufacturer of innovative biomedical measurement equipment. Founded in 1983, Transonic sells “gold standard” transit-time ultrasound flowmeters and monitors for surgical, hemodialysis, pediatric critical care, perfusion, interventional radiology and research applications. In addition, Transonic provides pressure and pressure volume systems, laser Doppler flowmeters and telemetry systems. AMERICAS EUROPE ASIA/PACIFIC JAPAN Transonic Systems Inc. 34 Dutch Mill Rd Ithaca, NY 14850 U.S.A. Tel: +1 607-257-5300 Fax: +1 607-257-7256 [email protected] Transonic Europe B.V. Business Park Stein 5 6181 MB Elsloo The Netherlands Tel: +31 43-407-7200 Fax: +31 43-407-7201 [email protected] Transonic Asia Inc. 6F-3 No 5 Hangsiang Rd Dayuan, Taoyuan County 33747 Taiwan, R.O.C. Tel: +886 3399-5806 Fax: +886 3399-5805 [email protected] Transonic Japan Inc. KS Bldg 201, 735-4 Kita-Akitsu Tokorozawa Saitama 359-0038 Japan Tel: +81 4-2946-8541 Fax: +81 04-2946-8542 [email protected] CP Bypass/ECMO Specifications HXL-Series Clamp-on Flowsensors APPLICATIONS • Artificial Heart & VAD Performance • Medical Device & Pump Engineering • Manufacturing & Compliance Flow Testing Transit-time ultrasound technology measures volume flow in tubing with Sensors specifically designed Tubing Flowsensors. Most non-aerated liquids can be measured, including saline and buffer solutions, blood and water. No physical contact is made with the fluid media. H-XL Series Flowsensors can be calibrated and programmed for up to four different fluid/temperature/tubing combinations and will work with most flexible tubing types (see next page). Sensor size is determined by outer tubing diameter. TUBING SENSOR SIZE H2XL H3XL H4XL BIDIRECTIONAL FLOW OUTPUTS resolution ID Wall Thickness OD inches inches inches In sizes 2XL-5XL ratio of tubing wall thickness to OD must not exceed 1.5 for PVC; 1:3 for silicone H5XL 1 max flow SYSTEM ACCURACY SPECIFICATIONS offset Absolute Accuracy max zero ULTRASOUND FREQUENCY mL/min 5V output in L/min mL/min % of reading MHz 1/8 0.5 1 ± 5.0 ± 10 3.6 3/16 1.0 2 ± 10.0 ± 10 3.6 1/4 1.0 2 ± 10.0 ± 10 2.4 5/16 1.0 2 ± 10.0 ± 10 2.4 H6XL 1/4 1/16 3/8 2.5 5 ± 30 ± 10 2.4 H7XL 1/4 3/32 7/16 5 10 ± 60 ± 10 1.8 H8XL 3/8 1/16 1/2 5 10 ± 60 ± 10 1.8 H9XL 3/8 3/32 9/16 5 10 ± 60 ± 10 1.8 H10XL 1/2 1/16 5/8 10 20 ± 120 ± 10 1.2 H11XL 1/2 3/32 11/16 10 20 ± 120 ± 10 1.2 H12XL 1/2 1/8 3/4 10 20 ± 120 ± 10 1.2 H14XL 5/8 1/8 7/8 25 50 ± 300 ± 10 1.2 H16XL 3/4 1/8 1 25 50 ± 300 ± 10 1.2 H20XL 1 1/8 1 1/4 50 100 ± 600 ± 10 1.2 Calibration is dependent on tubing material, wall thickness, ultrasound velocity of liquid flowing through the tube & temperature. 1. Resolution represents the smallest detectable flow change at 0.1 Hz filter (average flow output). 2. Absolute accuracy is comprised of zero stability, resolution and zero-offset effects. Stated values apply when flow rate is greater than 5% of maximum range and zero offset is nulled. HXL-FlowsensorSpecs(EC-33-tn)RevC2015A4 CP Bypass/ECMO HXL-Series Clamp-on Flowsensor cont. STOCK TUBING Procedure CAROTID SHUNTS PED CPB, ECMO ADULT CPB Cat # Tygon Stock Tubing TUBING (inches) Inner Wall Diameter Thickness If using tubing of different diameter or type, please discuss tubing with a customer service representative. HQ_ 2XL 3/32 x 1/32 Tygon ND 100-65; Tygon E-3603 HQ_ 3XL 1/8 x 3/32 Tygon E-3603 HQ_ 4XL 1/8 x 1/16 Tygon ND 100-65; Tygon E-3603 HQ_ 5XL 3/8 x 1/16 Tygon ND 100-65; Tygon E-3603 HQ_ 6XL 1/4 x 1/16 Tygon ND 100-65; Tygon E-3603 HQ_ 7XL 1/4 x 3/32 Tygon ND 100-65; Tygon E-3603 HQ_ 8XL 3/8 x 1/16 Tygon ND 100-65; Tygon E-3603 HQ_ 9XL 3/8 x 3/32 Tygon ND 100-65; Tygon E-3603 HQ_ 10XL 1/2 x 1/16 Tygon ND 100-65; Tygon E-3603 HQ_ 11XL 1/2 x 3/32 Tygon ND 100-65; Tygon E-3603 Transonic Systems Inc. is a global manufacturer of innovative biomedical measurement equipment. Founded in 1983, Transonic sells “gold standard” transit-time ultrasound flowmeters and monitors for surgical, hemodialysis, pediatric critical care, perfusion, interventional radiology and research applications. In addition, Transonic provides pressure and pressure volume systems, laser Doppler flowmeters and telemetry systems. www.transonic.com AMERICAS EUROPE ASIA/PACIFIC JAPAN Transonic Systems Inc. 34 Dutch Mill Rd Ithaca, NY 14850 U.S.A. Tel: +1 607-257-5300 Fax: +1 607-257-7256 [email protected] Transonic Europe B.V. Business Park Stein 205 6181 NB Elsloo The Netherlands Tel: +31 43-407-7200 Fax: +31 43-407-7201 [email protected] Transonic Asia Inc. 6F-3 No 5 Hangsiang Rd Dayuan, Taoyuan County 33747 Taiwan, R.O.C. Tel: +886 3399-5806 Fax: +886 3399-5805 [email protected] Transonic Japan Inc. KS Bldg 201, 735-4 Kita-Akitsu Tokorozawa Saitama 359-0038 Japan Tel: +81 4-2946-8541 Fax: +81 04-2946-8542 [email protected]