Verify Flow over a Wide Dynamic Range with Non-invasive ...

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

AMERICASTransonic Systems Inc.34 Dutch Mill RdIthaca, NY 14850U.S.A.Tel: +1 607-257-5300Fax: +1 [email protected]

EUROPETransonic Europe B.V.Business Park Stein 2056181 MB ElslooThe NetherlandsTel: +31 43-407-7200Fax: +31 [email protected]

ASIA/PACIFICTransonic Asia Inc.6F-3 No 5 Hangsiang RdDayuan, Taoyuan County33747 Taiwan, R.O.C.Tel: +886 3399-5806Fax: +886 [email protected]

JAPANTransonic Japan Inc.KS Bldg 201, 735-4 Kita-AkitsuTokorozawa Saitama359-0038 JapanTel: +81 4-2946-8541Fax: +81 [email protected]

www.transonic.com

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.

ExtracorporealCover(EC-100-fly)RevB 2015

ECMO/CP Bypass

“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.

Verify Pump & ECMO Circuit Flows for Critical Safety & Quality AssuranceTransonic® 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.

• Maintains Tubing Integrity

• Sensor Clips onto Existing Tubing

• Unmatched Accuracy ± 10% TRANSIT-TIME ULTRASOUND TECHNOLOGY

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® 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).

CLAMP-ON TUBING FLOWSENSOR

www.transonic.comHT110Datasheet(EC-101-ds)RevC2015USltr

ECMO/CP Bypass

H-XL Tubing FlowsensorsTransonic® 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.

Choosing Your Flowsensor SizeSensors are scaled in 1/16 inch increments to clamp around standard tubing diameters. TubingFlexible 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.

OptionalSensors 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.

CLAMP-ON FLOWSENSOR SIZES

SENSOR #

TUBING Cat # Suffix (metric tubes)OD (inches) ID X WALL (inches) OD (metric)

H2XL 1/8 x 5/32 3/32 x 1/32 4 mm -M4

H3XL 3/16 1/8 x 1/32 5 mm -M5

H4XL 1/4 1/8 x 1/16 6 mm -M6

H5XL 5/16 3/16 x 1/16 8 mm -M8

H6XL 3/8 1/4 x 1/16 9 mm -M9

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

Flowsensor on Tubing

HT110 Bypass Flowmeter

HT110 Bypass Flowmeter

Ensure Optimal Perfusion to Provide

Proactive Patient Management

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

Specifications

Extracorporeal

HXL-FlowsensorSpecs(EC-33-tn)RevC2015USltr

HXL-Series Clamp-on Flowsensors

APPLICATIONS• ArtificialHeart&VADPerformance

• MedicalDevice&PumpEngineering

• Manufacturing&ComplianceFlowTesting

Transit-timeultrasoundtechnologymeasuresvolumeflowintubingwithSensorsspecificallydesignedTubingFlowsensors.Mostnon-aeratedliquidscanbemeasured,includingsalineandbuffersolutions,bloodandwater.Nophysicalcontactismadewiththefluidmedia.H-XLSeriesFlowsensorscanbecalibratedandprogrammedforuptofourdifferentfluid/temperature/tubingcombinationsandwillworkwithmostflexibletubingtypes(seenextpage).Sensorsizeisdeterminedbyoutertubingdiameter.

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.

SENSOR SIZE

TUBINGBIDIRECTIONAL FLOW

OUTPUTSSYSTEM ACCURACY

SPECIFICATIONS ULTRASOUNDFREQUENCY

resolution1 max flow max zero offset

absolute accuracy

iD wall thickness OD

mL/min5V output

in L/minmL/min % of reading mHz

inches inches inches

H2XLin sizes 2XL-5XL ratio of tubing waLL tHickness to od must not eXceed 1.5 for pVc; 1:3 for siLicone

1/8 0.5 1 ± 5.0 ± 10 3.6

H3XL 3/16 1.0 2 ± 10.0 ± 10 3.6

H4XL 1/4 1.0 2 ± 10.0 ± 10 2.4

H5XL 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

Extracorporeal

HXL-Series Clamp-on Flowsensor cont.

STOCK TUBING

Procedure Cat #TUBING(inches)

InnerWall DiameterThickness

Tygon Stock Tubing Ifusingtubingofdifferentdiameterortype,pleasediscuss

tubingwithacustomerservicerepresentative.

CAROTID SHUNTS

HQ_2XL 3/32x1/32 TygonND100-65;TygonE-3603

HQ_3XL 1/8x3/32 TygonE-3603



PED CPB, ECMOHQ_6XL 1/4x1/16 TygonND100-65;TygonE-3603



ADULT CPBHQ_9XL 3/8x3/32 TygonND100-65;TygonE-3603




EUROPETransonic Europe B.V.Business Park Stein 2056181 NB ElslooThe NetherlandsTel: +31 43-407-7200Fax: +31 [email protected]



www.transonic.com


ECMO

Verify Flow in ECMO Circuits & Ensure Optimal Flow Delivery

ECMOMedical Note(EC-1-mn)RevC2013USltrwww.transonic.com

SUMMARY• Set pump occlusion

• Monitor arterial delivery throughout long ECMO runs

• Monitor patency of venous catheter

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 patient3. Helping to maintain secondary venous

drainage catheter patency for duration of the ECMO Run

4. Secondary bubble detection

SET ROLLER PUMP OCCLUSIONThe 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 RUNSA 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.

ASSISTS IN MAINTAINING SECONDARY MONITOR VENOUS DRAINAGE AND CATHETER PATENCY IN V-V ECMOSome 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 DETECTIONA 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 built-in bubble detection option that triggers an automatic pump shut-off. However, others are not using any air bubble detector.

Verify Flow in ECMO Circuits cont.


EUROPETransonic Europe B.V.Business Park Stein 56181 MB ElslooThe NetherlandsTel: +31 43-407-7200Fax: +31 [email protected]



www.transonic.com


ECMO

REFERENCESLabuz 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)

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: 162-166. (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)

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)

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)

Flow Verification during ECMO

with Transit-time Ultrasound Technology

ECMO

ECMOReferences(EC-50-ref)RevA2015USltr

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 Ultra-sonic Systems,” Proceedings of the 31st Annual Confer-ence 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 Refer-ence # 4T)

PUBlICATIONSLabuz 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)

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 Experimen-tal In Vitro Study,” Annals of Thorac Surg 1997; 63: 162-166. (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)

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)

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)

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