r o c rocsafe hybrid perfusion systemseresmed.com.tr/public/files/mini devre.pdf · 2018-09-19 ·...
TRANSCRIPT
ROCS
afeTM
Hyb
rid P
erfu
sion
Syst
em
Terumo CardiovasCular sysTems CorporaTion6200 Jackson roadann arbor, michigan 48103-9300usa734 663 4145 phone734 663 7981 fax800 521 2818 toll free
Terumo mediCal CorporaTionlatin american sales division8750 nW 36th street, suite 600miami, Florida 33178305 477 4822 phone 305 477 4872 fax800 283 7866 toll free
Terumo europe n.v.6researchpark Zone 2 Haasrode interleuvenlaan 40 B-3001 leuven, Belgium 32 16 38 12 11 phone 32 16 40 02 49 fax
Terumo CorporaTion44-1, 2-chome Hatagaya, shibuya-Ku Tokyo 151-0072 Japan 81 3 3374 8111 phone 81 3 3374 8196 fax
For more information, contact:
www.terumo-cvs.com Terumo® is a registered trademark of Terumo Corporation.©2009 Terumo Cardiovascular systems Corporation printed in the usa 819530
Thoughtful Design and Expert Support:Developed by the global leader in cardiopulmonary bypass
Terumo is the world’s leading supplier of perfusion products. Every day, more Terumo perfusion products are used in operating rooms around the world than any other manufacturer’s.
In the U.S., Terumo perfusion products are used by surgical teams at the country’s top heart hospitals. Terumo heart-lung machines, intraoperative monitoring systems, cannulae, and oxygenators are each used in the majority of the best 100 heart hospitals as ranked in 2007 by US News and World Report.7
Ordering Information product Code units/Case
ROCSafe Systems
roCsafe Hybrid perfusion system with rX 15 oxygenator 3roCrX15 1
roCsafe Hybrid perfusion system with rX 25 oxygenator 3roCrX25 1
Accessory Kits Available:
Hardshell venous reservoir Kit 3roCHr 2
Flexible Cardiotomy reservoir Kit 3roCFr 3
vent/sucker lines 3roCa 5
Brackets Required:
roCsafe Circuit Holder 1XX*CXH18 1
Cross bar for mounting 814858 1
Flexible mounting arm for occluder and Centrifugal pump 816620 1
Hardshell venous reservoir Holder 801804 1
Flexible Cardiotomy reservoir Holder 816181 1
FooTnoTes
1 stump, da, Triad of organ protection, The Heart Surgery Forum Reviews, 4(2)7-9.2 Hammon, JW, protecting the Brain and Cardiac surgery, The Heart Surgery Forum Reviews, 4(2)10-12.3 Kutschka, i, et al, a new minimized perfusion Circuit provides Highly effective ultrasound Controlled deairing, Artificial Organs, 31(3)215-220.4 shann, KG, et al, an evidence-based review of the practice of cardiopulmonary bypass in adults: a focus on neurologic injury, glycemic control, hemodilution, and the inflammatory response, The Journal of Thoracic and Cardiovascular Surgery, 2006;132:283-90.5 deFoe, Gr, et al, lowest Hematocrit on Bypass and adverse outcomes associated With Coronary artery Bypass Grafting, Annals of Thoracic Surgery, 2001, 71:769-76.6 Gunaydin, s, emerging Technologies in Biocompatible surface modifying additives: Quest of physiologic Cardiopulmonary Bypass, Current Medicinal Chemistry – Cardiovascular & Hematological Agents, 2004, 2:295-302.7 america’s Best Hospitals 2007, US News & World Report.
Product Specifications
Oxygenator CapioX® rX15 CapioX® rX25
membrane type microporous microporous polypropylene polypropylene
membrane surface area 1.5m2 2.5m2
Heat exchanger stainless steel stainless steel
Heat exchanger surface area 0.14m2 0.2m2
XCoating yes yes
Bubble Trap
Filter material polyester
Filter pore size 170 micron (um)
XCoating yes
Centrifugal Pump
XCoating yes
Arterial Filter
Filter material polyester
Filter pore size 37 um
Filter area 645 cm2
XCoating yes
ROCSafe™ Hybrid Perfusion System
For Best Practices in Blood Management
ROCSafe™ Hybrid Perfusion System
R O C means Reservoir Optional Circuit. A hybrid electric vehicle uses two or more distinct power sources to propel the vehicle. The ROCSafe Hybrid Perfusion System instantly converts between its reservoir-less core configuration to a conventional configuration with a hardshell venous reservoir (see illustration), allowing clinical teams to implement today’s best blood management strategies without compromising safety or ease of use:
n Reduced hemodilution The ROCSafe system has the lowest prime volume of any commercially available circuit:
With CAPIOX® RX15 Oxygenator 665 mL With CAPIOX® RX25 Oxygenator 780 mL When using RAP techniques the majority of prime volume can be removed
n Reduced surface area The total surface area of the ROCSafe system’s core configuration is only 1.9 m2. This represents a surface area reduction of approximately 50% compared to a conventional circuit.
n Utilization of a biopassive polymer coating The blood contact areas of the circuit are coated with Terumo’s own XCoating™, shown to reduce platelet adhesion and protein denaturation to prevent activation and blood reactions to foreign surfaces.
Safe doesn’t need a definition. n Exclusive air handling features The ROCSafe system is designed exclusively for use with the Terumo® Advanced Perfusion System 1; the combined platforms effectively prevent air from travelling beyond the venous filter through the circuit. A venous line ultrasonic air bubble detector automatically engages the Coast™ Response of the centrifugal pump to temporarily suspend blood flow and simultaneously occlude the venous line allowing the clinician to remove the air.
n Adaptability The ROCSafe system seamlessly switches configurations during a case to reduce the potential complications of cardiopulmonary bypass. The user can add sections of the circuit as needed, whether converting from complete to partial cardiopulmonary support, or choosing regular or selective use of a hardshell reservoir.
n Ease of use The ROCSafe system is a pre-connected circuit designed for simplicity. The entire circuit mounts on its bracket and is ready for priming with a simple click. Optional accessory packs are available for adding a hardshell reservoir or flexible cardiotomy reservoir for volume management. These can be added at any time, before or during the procedure. And the simple blood path is easy to follow and monitor during the case.
n Training Terumo’s expert Clinical Support team is available to provide a custom training experience, including one-on-one in-service and advanced perfusion simulation training.
A successful hybrid blends the best features of two separate technologies. It extends what is possible. Think of the hybrid engine that switches between gas and electric power to reduce emissions and improve mileage — while maintaining performance.
Now imagine a perfusion system that seamlessly switches between circuit configurations during a case to reduce the potential complications of cardiopulmonary bypass while maintaining safe and reliable perfusion.
That’s the ROCSafeTM Hybrid Perfusion System.
The ROCSafe system is an intuitively designed, ergonomic system that allows clinical teams to practice today’s best blood management strategies during any cardiopulmonary bypass procedure:
As the cardiac surgery community increases its focus on blood management strategies, the ROCSafe system can assist to decrease activation, decrease hemodilution and reduce the need for blood transfusions. The ROCSafe system continues to provide the high level of safety that has been demonstrated when using Terumo® products.
nRoutine CABG nCABG/valve combinations nPerfusion-assisted beating heart nComplex vascular procedures
nEmergencies nEvolving protocols nConditions requiring unique bypass support strategies
Reduced Risk of Gaseous Microemboli:Safety features prevent air from reaching patient Studies suggest that the presence of gaseous microemboli (GME) in the perfusion circuit is a clinical concern; some have demonstrated an association between GME and neurological damage or other organ failure after cardiac surgery.1, 2
The ROCSafe system has proven more effective at trapping and removing air than a traditional perfusion circuit. It utilizes the exclusive safety features of the Terumo® Advanced Perfusion System 1 to actively trap GME as they enter the circuit, preventing them from reaching the patient.3
Figure 1Reduced GME: ROCSafe passes 40% fewer GME than conventional circuits.
Conventional Circuit ROCSafe System
ROCS
afeTM
Hyb
rid P
erfu
sion
Syst
em
Air Removal
1. Air bubble detector detects venous air2. Air bubble detector sends a signal to centrifugal pump to engage CoastTM Response3. Centrifugal pump slows to 1500 rpm and venous occluder closes4. Clinician removes air from venous bubble trap5. Clinician restarts sytem
ROCSafe™ Hybrid Perfusion System
Optional Hardshell Reservoir Accessory Kit
Centrifugal Pump
VenousOccluder
VenousBubble Trap
ArterialFilter
CAPIOX®
RX15/RX25Oxygenator
Optional FlexibleReservoir Accessory Kit
Volume ManagementBridge
Add Volume
Remove Volume
Air Bubble Detector
Roller Pump
Venous LineConnections
To Vent
From Patient
To ROCSafe Core Circuit
Reduced Activation:Minimizing blood exposure to foreign surface area and blood-air interface throughout the procedure reduces the incidence of SIRS3
The inflammatory response to cardiopulmonary bypass caused by the blood-air interface and blood exposure to foreign surfaces has long been recognized as a major clinical issue that affects outcomes in cardiac surgery. Post operative complications vary but can include renal, pulmonary, cardiac and cerebral dysfunction that can lead to prolonged ICU stay, ventilation time, the need for additional inotropic support and the associated costs and risks.4
The ROCSafe system allows clinical teams to minimize blood exposure to foreign surface area at any time during a procedure. The core configuration is a closed, reservoir-less system with 45% less surface area than a conventional circuit. Should the clinical team need to add a reservoir — during the valve repair portion of a CABG/valve case for instance — it can be done with a simple click.
Blood Conservation:Reducing hemodilution by minimizing prime volume decreases the need for blood transfusions
Impact of Priming Volume on Hematocrit Levels
Table 1The calculations show how reducing the prime volume decreases the hematocrit for an 85 kilogram patient with a starting hematocrit of 35.
Numerous studies have documented that reducing hemodilution during cardiopulmonary bypass reduces the need for blood transfusions and thereby reduces morbidity and mortality.5
The core configuration of the ROCSafe system has a prime volume of 665 mL, the lowest prime volume of any commercially available reduced prime circuit. The user can virtually eliminate prime volume by using retrograde autologous priming (RAP) techniques.
Figure 3Reduced Prime: The ROCSafe system has a prime volume of 665 mL: 60% lower than the typical circuit’s 2 L.
Typical Prime 2 L
ROCSafe System Prime 665 mL
No Added Heparin:Polymer-based surface coating is safe for heparin intolerant patients
Today, the majority of cardiac centers choose polymer-based coatings over heparin-based coatings because polymer coatings have shown to provide the same or better benefits without the risk of a patient heparin reaction.
The ROCSafe system is coated with XCoating™, Terumo’s own biopassive polymer surface coating that reduces platelet activation and protein denaturing. Studies have shown that using XCoating helps reduce bleeding and SIRS in cardiac surgery patients undergoing cardiopulmonary bypass.6
Figure 2Reduced surface area: The ROCSafe system has 45% less surface area than a conventional circuit.
Conventional Circuit
ROCSafe System
A successful hybrid blends the best features of two separate technologies. It extends what is possible. Think of the hybrid engine that switches between gas and electric power to reduce emissions and improve mileage — while maintaining performance.
Now imagine a perfusion system that seamlessly switches between circuit configurations during a case to reduce the potential complications of cardiopulmonary bypass while maintaining safe and reliable perfusion.
That’s the ROCSafeTM Hybrid Perfusion System.
The ROCSafe system is an intuitively designed, ergonomic system that allows clinical teams to practice today’s best blood management strategies during any cardiopulmonary bypass procedure:
As the cardiac surgery community increases its focus on blood management strategies, the ROCSafe system can assist to decrease activation, decrease hemodilution and reduce the need for blood transfusions. The ROCSafe system continues to provide the high level of safety that has been demonstrated when using Terumo® products.
nRoutine CABG nCABG/valve combinations nPerfusion-assisted beating heart nComplex vascular procedures
nEmergencies nEvolving protocols nConditions requiring unique bypass support strategies
Reduced Risk of Gaseous Microemboli:Safety features prevent air from reaching patient Studies suggest that the presence of gaseous microemboli (GME) in the perfusion circuit is a clinical concern; some have demonstrated an association between GME and neurological damage or other organ failure after cardiac surgery.1, 2
The ROCSafe system has proven more effective at trapping and removing air than a traditional perfusion circuit. It utilizes the exclusive safety features of the Terumo® Advanced Perfusion System 1 to actively trap GME as they enter the circuit, preventing them from reaching the patient.3
Figure 1Reduced GME: ROCSafe passes 40% fewer GME than conventional circuits.
Conventional Circuit ROCSafe System
ROCS
afeTM
Hyb
rid P
erfu
sion
Syst
em
Air Removal
1. Air bubble detector detects venous air2. Air bubble detector sends a signal to centrifugal pump to engage CoastTM Response3. Centrifugal pump slows to 1500 rpm and venous occluder closes4. Clinician removes air from venous bubble trap5. Clinician restarts sytem
ROCSafe™ Hybrid Perfusion System
Optional Hardshell Reservoir Accessory Kit
Centrifugal Pump
VenousOccluder
VenousBubble Trap
ArterialFilter
CAPIOX®
RX15/RX25Oxygenator
Optional FlexibleReservoir Accessory Kit
Volume ManagementBridge
Add Volume
Remove Volume
Air Bubble Detector
Roller Pump
Venous LineConnections
To Vent
From Patient
To ROCSafe Core Circuit
Reduced Activation:Minimizing blood exposure to foreign surface area and blood-air interface throughout the procedure reduces the incidence of SIRS3
The inflammatory response to cardiopulmonary bypass caused by the blood-air interface and blood exposure to foreign surfaces has long been recognized as a major clinical issue that affects outcomes in cardiac surgery. Post operative complications vary but can include renal, pulmonary, cardiac and cerebral dysfunction that can lead to prolonged ICU stay, ventilation time, the need for additional inotropic support and the associated costs and risks.4
The ROCSafe system allows clinical teams to minimize blood exposure to foreign surface area at any time during a procedure. The core configuration is a closed, reservoir-less system with 45% less surface area than a conventional circuit. Should the clinical team need to add a reservoir — during the valve repair portion of a CABG/valve case for instance — it can be done with a simple click.
Blood Conservation:Reducing hemodilution by minimizing prime volume decreases the need for blood transfusions
Impact of Priming Volume on Hematocrit Levels
Table 1The calculations show how reducing the prime volume decreases the hematocrit for an 85 kilogram patient with a starting hematocrit of 35.
Numerous studies have documented that reducing hemodilution during cardiopulmonary bypass reduces the need for blood transfusions and thereby reduces morbidity and mortality.5
The core configuration of the ROCSafe system has a prime volume of 665 mL, the lowest prime volume of any commercially available reduced prime circuit. The user can virtually eliminate prime volume by using retrograde autologous priming (RAP) techniques.
Figure 3Reduced Prime: The ROCSafe system has a prime volume of 665 mL: 60% lower than the typical circuit’s 2 L.
Typical Prime 2 L
ROCSafe System Prime 665 mL
No Added Heparin:Polymer-based surface coating is safe for heparin intolerant patients
Today, the majority of cardiac centers choose polymer-based coatings over heparin-based coatings because polymer coatings have shown to provide the same or better benefits without the risk of a patient heparin reaction.
The ROCSafe system is coated with XCoating™, Terumo’s own biopassive polymer surface coating that reduces platelet activation and protein denaturing. Studies have shown that using XCoating helps reduce bleeding and SIRS in cardiac surgery patients undergoing cardiopulmonary bypass.6
Figure 2Reduced surface area: The ROCSafe system has 45% less surface area than a conventional circuit.
Conventional Circuit
ROCSafe System
A successful hybrid blends the best features of two separate technologies. It extends what is possible. Think of the hybrid engine that switches between gas and electric power to reduce emissions and improve mileage — while maintaining performance.
Now imagine a perfusion system that seamlessly switches between circuit configurations during a case to reduce the potential complications of cardiopulmonary bypass while maintaining safe and reliable perfusion.
That’s the ROCSafeTM Hybrid Perfusion System.
The ROCSafe system is an intuitively designed, ergonomic system that allows clinical teams to practice today’s best blood management strategies during any cardiopulmonary bypass procedure:
As the cardiac surgery community increases its focus on blood management strategies, the ROCSafe system can assist to decrease activation, decrease hemodilution and reduce the need for blood transfusions. The ROCSafe system continues to provide the high level of safety that has been demonstrated when using Terumo® products.
nRoutine CABG nCABG/valve combinations nPerfusion-assisted beating heart nComplex vascular procedures
nEmergencies nEvolving protocols nConditions requiring unique bypass support strategies
Reduced Risk of Gaseous Microemboli:Safety features prevent air from reaching patient Studies suggest that the presence of gaseous microemboli (GME) in the perfusion circuit is a clinical concern; some have demonstrated an association between GME and neurological damage or other organ failure after cardiac surgery.1, 2
The ROCSafe system has proven more effective at trapping and removing air than a traditional perfusion circuit. It utilizes the exclusive safety features of the Terumo® Advanced Perfusion System 1 to actively trap GME as they enter the circuit, preventing them from reaching the patient.3
Figure 1Reduced GME: ROCSafe passes 40% fewer GME than conventional circuits.
Conventional Circuit ROCSafe System
ROCS
afeTM
Hyb
rid P
erfu
sion
Syst
em
Air Removal
1. Air bubble detector detects venous air2. Air bubble detector sends a signal to centrifugal pump to engage CoastTM Response3. Centrifugal pump slows to 1500 rpm and venous occluder closes4. Clinician removes air from venous bubble trap5. Clinician restarts sytem
ROCSafe™ Hybrid Perfusion System
Optional Hardshell Reservoir Accessory Kit
Centrifugal Pump
VenousOccluder
VenousBubble Trap
ArterialFilter
CAPIOX®
RX15/RX25Oxygenator
Optional FlexibleReservoir Accessory Kit
Volume ManagementBridge
Add Volume
Remove Volume
Air Bubble Detector
Roller Pump
Venous LineConnections
To Vent
From Patient
To ROCSafe Core Circuit
Reduced Activation:Minimizing blood exposure to foreign surface area and blood-air interface throughout the procedure reduces the incidence of SIRS3
The inflammatory response to cardiopulmonary bypass caused by the blood-air interface and blood exposure to foreign surfaces has long been recognized as a major clinical issue that affects outcomes in cardiac surgery. Post operative complications vary but can include renal, pulmonary, cardiac and cerebral dysfunction that can lead to prolonged ICU stay, ventilation time, the need for additional inotropic support and the associated costs and risks.4
The ROCSafe system allows clinical teams to minimize blood exposure to foreign surface area at any time during a procedure. The core configuration is a closed, reservoir-less system with 45% less surface area than a conventional circuit. Should the clinical team need to add a reservoir — during the valve repair portion of a CABG/valve case for instance — it can be done with a simple click.
Blood Conservation:Reducing hemodilution by minimizing prime volume decreases the need for blood transfusions
Impact of Priming Volume on Hematocrit Levels
Table 1The calculations show how reducing the prime volume decreases the hematocrit for an 85 kilogram patient with a starting hematocrit of 35.
Numerous studies have documented that reducing hemodilution during cardiopulmonary bypass reduces the need for blood transfusions and thereby reduces morbidity and mortality.5
The core configuration of the ROCSafe system has a prime volume of 665 mL, the lowest prime volume of any commercially available reduced prime circuit. The user can virtually eliminate prime volume by using retrograde autologous priming (RAP) techniques.
Figure 3Reduced Prime: The ROCSafe system has a prime volume of 665 mL: 60% lower than the typical circuit’s 2 L.
Typical Prime 2 L
ROCSafe System Prime 665 mL
No Added Heparin:Polymer-based surface coating is safe for heparin intolerant patients
Today, the majority of cardiac centers choose polymer-based coatings over heparin-based coatings because polymer coatings have shown to provide the same or better benefits without the risk of a patient heparin reaction.
The ROCSafe system is coated with XCoating™, Terumo’s own biopassive polymer surface coating that reduces platelet activation and protein denaturing. Studies have shown that using XCoating helps reduce bleeding and SIRS in cardiac surgery patients undergoing cardiopulmonary bypass.6
Figure 2Reduced surface area: The ROCSafe system has 45% less surface area than a conventional circuit.
Conventional Circuit
ROCSafe System
ROCS
afeTM
Hyb
rid P
erfu
sion
Syst
em
Terumo CardiovasCular sysTems CorporaTion6200 Jackson roadann arbor, michigan 48103-9300usa734 663 4145 phone734 663 7981 fax800 521 2818 toll free
Terumo mediCal CorporaTionlatin american sales division8750 nW 36th street, suite 600miami, Florida 33178305 477 4822 phone 305 477 4872 fax800 283 7866 toll free
Terumo europe n.v.6researchpark Zone 2 Haasrode interleuvenlaan 40 B-3001 leuven, Belgium 32 16 38 12 11 phone 32 16 40 02 49 fax
Terumo CorporaTion44-1, 2-chome Hatagaya, shibuya-Ku Tokyo 151-0072 Japan 81 3 3374 8111 phone 81 3 3374 8196 fax
For more information, contact:
www.terumo-cvs.com Terumo® is a registered trademark of Terumo Corporation.©2009 Terumo Cardiovascular systems Corporation printed in the usa 819530
Thoughtful Design and Expert Support:Developed by the global leader in cardiopulmonary bypass
Terumo is the world’s leading supplier of perfusion products. Every day, more Terumo perfusion products are used in operating rooms around the world than any other manufacturer’s.
In the U.S., Terumo perfusion products are used by surgical teams at the country’s top heart hospitals. Terumo heart-lung machines, intraoperative monitoring systems, cannulae, and oxygenators are each used in the majority of the best 100 heart hospitals as ranked in 2007 by US News and World Report.7
Ordering Information product Code units/Case
ROCSafe Systems
roCsafe Hybrid perfusion system with rX 15 oxygenator 3roCrX15 1
roCsafe Hybrid perfusion system with rX 25 oxygenator 3roCrX25 1
Accessory Kits Available:
Hardshell venous reservoir Kit 3roCHr 2
Flexible Cardiotomy reservoir Kit 3roCFr 3
vent/sucker lines 3roCa 5
Brackets Required:
roCsafe Circuit Holder 1XX*CXH18 1
Cross bar for mounting 814858 1
Flexible mounting arm for occluder and Centrifugal pump 816620 1
Hardshell venous reservoir Holder 801804 1
Flexible Cardiotomy reservoir Holder 816181 1
FooTnoTes
1 stump, da, Triad of organ protection, The Heart Surgery Forum Reviews, 4(2)7-9.2 Hammon, JW, protecting the Brain and Cardiac surgery, The Heart Surgery Forum Reviews, 4(2)10-12.3 Kutschka, i, et al, a new minimized perfusion Circuit provides Highly effective ultrasound Controlled deairing, Artificial Organs, 31(3)215-220.4 shann, KG, et al, an evidence-based review of the practice of cardiopulmonary bypass in adults: a focus on neurologic injury, glycemic control, hemodilution, and the inflammatory response, The Journal of Thoracic and Cardiovascular Surgery, 2006;132:283-90.5 deFoe, Gr, et al, lowest Hematocrit on Bypass and adverse outcomes associated With Coronary artery Bypass Grafting, Annals of Thoracic Surgery, 2001, 71:769-76.6 Gunaydin, s, emerging Technologies in Biocompatible surface modifying additives: Quest of physiologic Cardiopulmonary Bypass, Current Medicinal Chemistry – Cardiovascular & Hematological Agents, 2004, 2:295-302.7 america’s Best Hospitals 2007, US News & World Report.
Product Specifications
Oxygenator CapioX® rX15 CapioX® rX25
membrane type microporous microporous polypropylene polypropylene
membrane surface area 1.5m2 2.5m2
Heat exchanger stainless steel stainless steel
Heat exchanger surface area 0.14m2 0.2m2
XCoating yes yes
Bubble Trap
Filter material polyester
Filter pore size 170 micron (um)
XCoating yes
Centrifugal Pump
XCoating yes
Arterial Filter
Filter material polyester
Filter pore size 37 um
Filter area 645 cm2
XCoating yes
ROCSafe™ Hybrid Perfusion System
For Best Practices in Blood Management
ROCSafe™ Hybrid Perfusion System
R O C means Reservoir Optional Circuit. A hybrid electric vehicle uses two or more distinct power sources to propel the vehicle. The ROCSafe Hybrid Perfusion System instantly converts between its reservoir-less core configuration to a conventional configuration with a hardshell venous reservoir (see illustration), allowing clinical teams to implement today’s best blood management strategies without compromising safety or ease of use:
n Reduced hemodilution The ROCSafe system has the lowest prime volume of any commercially available circuit:
With CAPIOX® RX15 Oxygenator 665 mL With CAPIOX® RX25 Oxygenator 780 mL When using RAP techniques the majority of prime volume can be removed
n Reduced surface area The total surface area of the ROCSafe system’s core configuration is only 1.9 m2. This represents a surface area reduction of approximately 50% compared to a conventional circuit.
n Utilization of a biopassive polymer coating The blood contact areas of the circuit are coated with Terumo’s own XCoating™, shown to reduce platelet adhesion and protein denaturation to prevent activation and blood reactions to foreign surfaces.
Safe doesn’t need a definition. n Exclusive air handling features The ROCSafe system is designed exclusively for use with the Terumo® Advanced Perfusion System 1; the combined platforms effectively prevent air from travelling beyond the venous filter through the circuit. A venous line ultrasonic air bubble detector automatically engages the Coast™ Response of the centrifugal pump to temporarily suspend blood flow and simultaneously occlude the venous line allowing the clinician to remove the air.
n Adaptability The ROCSafe system seamlessly switches configurations during a case to reduce the potential complications of cardiopulmonary bypass. The user can add sections of the circuit as needed, whether converting from complete to partial cardiopulmonary support, or choosing regular or selective use of a hardshell reservoir.
n Ease of use The ROCSafe system is a pre-connected circuit designed for simplicity. The entire circuit mounts on its bracket and is ready for priming with a simple click. Optional accessory packs are available for adding a hardshell reservoir or flexible cardiotomy reservoir for volume management. These can be added at any time, before or during the procedure. And the simple blood path is easy to follow and monitor during the case.
n Training Terumo’s expert Clinical Support team is available to provide a custom training experience, including one-on-one in-service and advanced perfusion simulation training.
ROCS
afeTM
Hyb
rid P
erfu
sion
Syst
em
Terumo CardiovasCular sysTems CorporaTion6200 Jackson roadann arbor, michigan 48103-9300usa734 663 4145 phone734 663 7981 fax800 521 2818 toll free
Terumo mediCal CorporaTionlatin american sales division8750 nW 36th street, suite 600miami, Florida 33178305 477 4822 phone 305 477 4872 fax800 283 7866 toll free
Terumo europe n.v.6researchpark Zone 2 Haasrode interleuvenlaan 40 B-3001 leuven, Belgium 32 16 38 12 11 phone 32 16 40 02 49 fax
Terumo CorporaTion44-1, 2-chome Hatagaya, shibuya-Ku Tokyo 151-0072 Japan 81 3 3374 8111 phone 81 3 3374 8196 fax
For more information, contact:
www.terumo-cvs.com Terumo® is a registered trademark of Terumo Corporation.©2009 Terumo Cardiovascular systems Corporation printed in the usa 819530
Thoughtful Design and Expert Support:Developed by the global leader in cardiopulmonary bypass
Terumo is the world’s leading supplier of perfusion products. Every day, more Terumo perfusion products are used in operating rooms around the world than any other manufacturer’s.
In the U.S., Terumo perfusion products are used by surgical teams at the country’s top heart hospitals. Terumo heart-lung machines, intraoperative monitoring systems, cannulae, and oxygenators are each used in the majority of the best 100 heart hospitals as ranked in 2007 by US News and World Report.7
Ordering Information product Code units/Case
ROCSafe Systems
roCsafe Hybrid perfusion system with rX 15 oxygenator 3roCrX15 1
roCsafe Hybrid perfusion system with rX 25 oxygenator 3roCrX25 1
Accessory Kits Available:
Hardshell venous reservoir Kit 3roCHr 2
Flexible Cardiotomy reservoir Kit 3roCFr 3
vent/sucker lines 3roCa 5
Brackets Required:
roCsafe Circuit Holder 1XX*CXH18 1
Cross bar for mounting 814858 1
Flexible mounting arm for occluder and Centrifugal pump 816620 1
Hardshell venous reservoir Holder 801804 1
Flexible Cardiotomy reservoir Holder 816181 1
FooTnoTes
1 stump, da, Triad of organ protection, The Heart Surgery Forum Reviews, 4(2)7-9.2 Hammon, JW, protecting the Brain and Cardiac surgery, The Heart Surgery Forum Reviews, 4(2)10-12.3 Kutschka, i, et al, a new minimized perfusion Circuit provides Highly effective ultrasound Controlled deairing, Artificial Organs, 31(3)215-220.4 shann, KG, et al, an evidence-based review of the practice of cardiopulmonary bypass in adults: a focus on neurologic injury, glycemic control, hemodilution, and the inflammatory response, The Journal of Thoracic and Cardiovascular Surgery, 2006;132:283-90.5 deFoe, Gr, et al, lowest Hematocrit on Bypass and adverse outcomes associated With Coronary artery Bypass Grafting, Annals of Thoracic Surgery, 2001, 71:769-76.6 Gunaydin, s, emerging Technologies in Biocompatible surface modifying additives: Quest of physiologic Cardiopulmonary Bypass, Current Medicinal Chemistry – Cardiovascular & Hematological Agents, 2004, 2:295-302.7 america’s Best Hospitals 2007, US News & World Report.
Product Specifications
Oxygenator CapioX® rX15 CapioX® rX25
membrane type microporous microporous polypropylene polypropylene
membrane surface area 1.5m2 2.5m2
Heat exchanger stainless steel stainless steel
Heat exchanger surface area 0.14m2 0.2m2
XCoating yes yes
Bubble Trap
Filter material polyester
Filter pore size 170 micron (um)
XCoating yes
Centrifugal Pump
XCoating yes
Arterial Filter
Filter material polyester
Filter pore size 37 um
Filter area 645 cm2
XCoating yes
ROCSafe™ Hybrid Perfusion System
For Best Practices in Blood Management
ROCSafe™ Hybrid Perfusion System
R O C means Reservoir Optional Circuit. A hybrid electric vehicle uses two or more distinct power sources to propel the vehicle. The ROCSafe Hybrid Perfusion System instantly converts between its reservoir-less core configuration to a conventional configuration with a hardshell venous reservoir (see illustration), allowing clinical teams to implement today’s best blood management strategies without compromising safety or ease of use:
n Reduced hemodilution The ROCSafe system has the lowest prime volume of any commercially available circuit:
With CAPIOX® RX15 Oxygenator 665 mL With CAPIOX® RX25 Oxygenator 780 mL When using RAP techniques the majority of prime volume can be removed
n Reduced surface area The total surface area of the ROCSafe system’s core configuration is only 1.9 m2. This represents a surface area reduction of approximately 50% compared to a conventional circuit.
n Utilization of a biopassive polymer coating The blood contact areas of the circuit are coated with Terumo’s own XCoating™, shown to reduce platelet adhesion and protein denaturation to prevent activation and blood reactions to foreign surfaces.
Safe doesn’t need a definition. n Exclusive air handling features The ROCSafe system is designed exclusively for use with the Terumo® Advanced Perfusion System 1; the combined platforms effectively prevent air from travelling beyond the venous filter through the circuit. A venous line ultrasonic air bubble detector automatically engages the Coast™ Response of the centrifugal pump to temporarily suspend blood flow and simultaneously occlude the venous line allowing the clinician to remove the air.
n Adaptability The ROCSafe system seamlessly switches configurations during a case to reduce the potential complications of cardiopulmonary bypass. The user can add sections of the circuit as needed, whether converting from complete to partial cardiopulmonary support, or choosing regular or selective use of a hardshell reservoir.
n Ease of use The ROCSafe system is a pre-connected circuit designed for simplicity. The entire circuit mounts on its bracket and is ready for priming with a simple click. Optional accessory packs are available for adding a hardshell reservoir or flexible cardiotomy reservoir for volume management. These can be added at any time, before or during the procedure. And the simple blood path is easy to follow and monitor during the case.
n Training Terumo’s expert Clinical Support team is available to provide a custom training experience, including one-on-one in-service and advanced perfusion simulation training.