HemoSonics

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Hemosonics-Quantra-unit

Quantra Hemostasis System

The Quantra System is the only whole blood hemostasis analyzer cleared by the FDA for use in cardiac, trauma, liver transplantation, and major orthopedic surgeries – making Quantra a trulycomprehensive solution for system-wide bleeding management.(1-3)
Easily standardize across your health system to provide goal-directed therapy and help optimize blood product usage

The Next Generation of Viscoelastic Hemostasis Testing

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Expanded Menu of Cartridge Tests for
Hemostasis Monitoring in Critical Care Settings

Expanded Menu of Cartridge Tests for Hemostasis Monitoring in Critical Care Settings

Hemosonics-Qplus-cartridge-logo
Hemosonics-QPlus-cartridge

Cardiovascular and Major Orthopedic Surgery

QPlus Cartridge Time Parameters(1):

Initial results in ~5 minutes

Complete results in ~12.5 minutes

Dials
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Trends
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Curves
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The Quantra System is currently the only VET system that directly outputs both Fibrinogen (FCS) and Platelet (PCS) Contributions to Clot Stiffness in one cartridge, helping clinicians better determine which blood products may be needed for individual patients.(1,19)
Hemosonics-Qstat-logo
Hemosonics-QStat-cartridge

Trauma and Liver Transplantation

QStat Cartridge time to results(2):
Initial results in ~ 5 minutes
Results in ~ 12.5 minutes
Lysis results in 25 – 60 minutes
Multiple display screens present a comprehensive review of results for easy interpretation.(3)
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Technical Specifications

Quantra QPlus and QStat Output Parameters
Parameter Unit Reportable Ranges Description
CT: Clot Time seconds (sec) 60-480 Clot time in citrated whole blood
CTH: Clot time with Heparinase
QPlus Cartridge only
seconds (sec) 60-480 Clot time in citrated whole blood with heparin neutralization
CTR: Clot Time Ratio
QPlus Cartridge only
N/A 0.8 to 4 Ratio of CT/CTH; CTR > 1.4 indicates prolongation of CT, likely due to herapin
CSL: Clot Stability to Lysis
QStat Cartridge only
percent (%) 10-100 Reduction of clot stiffness, likely due to fibrinolysis
CS: Clot Stiffness* hectoPascals (hPa) 2-65 Stiffness of the whole blood clot
PCS: Platelet Contribution to Clot Stiffness* hectoPascals (hPa) 2-65 Contribution of platelet activity to overall clot stiffness
FCS: Fibrinogen Contribution to Clot Stiffness* hectoPascals (hPa) 0.2-30 Contribution of functional fibrinogen to overall clot stiffness
*Heparin insensitive (6 IU/mL).1
Principle
Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry is a proprietary ultrasound technology that directly measures the changes in viscoelastic properties (shear modulus) of whole blood during coagulation and clot lysis.
Configuration
Cartridge based sealed system; closed tube sampling.
Sample Volume
2.7 mL fill in a 3 mL (3.2% citrated) blue-top tube.
Connectivity
Data Input and Output 3 USB in the rear, 1 USB in front 1- RJ45 ethernet connector in the rear
Integrated Outputs CLSI LIS02-A2, CLSI POCT01-A2
Middleware Drivers RALS, TELCOR®, UniPOC®, cobas® infinity, DI Data Innovations®
LIS Interface CLSI LIS01-A2 Standard
Physical Characteristics and Footprint
Dimensions 36 cm (w) x 49 cm (h) x 30 cm (d)
Weight 16.5 kg
Clearance Top 2.5 cm, Sides 5.5 cm, Rear 5.5 cm
Display 22 cm x 14 cm LCD Touch Screen
Electrical Specifications
Voltage 100-240 VAC
Current 1.3 A
Power Input Maximum 250 Watts/Output 75 Watts
Frequency 50/60 Hz
Power Connection Standard 3-prong grounded; *hospital-grade cord*
System Parts and Accessories
System Component Ref. #
Quantra Hemostasis Analyzer HS-002
QPlus® Cartridge, Kit of 10 KT-0004
QPlus Control Level 1, Kit of 4 (Lyophilized 2-8 C) KT-0023
QPlus Control Level 2, Kit of 4 (Lyophilized 2-8 C) KT-0025
QStat Cartridge, Kit of 10 KT-0020
QStat Control Level 1, Kit of 4 (Lyophilized 2-8 C) KT-0027
QStat Control Level 2, Kit of 4 (Lyophilized 2-8 C) KT-0032
US Power Cord/Barcode Scanner Kit KT-0037
Cleaning Cartridge, Kit of 10 KT-0012
Quantra Printer KT-0015
Printer Paper Kit, 10 rolls KT-0030
Uninterruptible Power Supply KT-0043
Quantra Desktop Remote Viewer Software KT-0039
Indications: The Quantra Hemostasis System is comprised of the Quantra Hemostasis Analyzer, QPlus Cartridge, QStat Cartridge, Quantra Quality Controls (Level 1 and Level 2), Quantra Cleaning Cartridge, and Quantra Desktop Remote Viewer (QDRV) Software.
The QPlus Cartridge is indicated for the evaluation of blood coagulation in perioperative patients age 18 years and older to assess possible hypocoagulable and hypercoagulable conditions in cardiovascular or major orthopedic surgeries before, during, and following the procedure.
The QStat Cartridge is indicated for the evaluation of blood coagulation and clot lysis in patients age 18 years and older to assess possible hypocoagulable and hypercoagulable conditions in trauma and liver transplantation procedures

Results obtained with the Quantra System should not be the sole basis for patient diagnosis.

Rx Only.

References: 1. QPlus Cartridge Instructions for Use (IFU). HemoSonics, LLC. 2. QStat Cartridge Instructions for Use (IFU). HemoSonics, LLC. 3.Quantra® Hemostasis Analyzer User Manual. 2020. HemoSonics, LLC. 4. Baulig W, Akbas S, Schütt PK, et al. Comparison of the resonance sonorheometry based Quantra® system with rotational thromboelastometry ROTEM® sigma in cardiac surgery – a prospective observational study. BMC Anesthesiol. 2021;21(1):260. 5. Idowu O, Ifeanyi-Pillette I,Owusu-Agyemang P, et al. The quantra hemostasisanalyzer compared to thromboelastography (TEG) in the surgical oncologic population: a prospective observational trial. J Surg Oncol. 2021;124(5):894-905. 6. Michelson EA, Cripps MW, Ray B, Winegar DA, Viola F. Initial clinical experience with the Quantra QStat System in adult trauma patients. Trauma Surg Acute Care Open. 2020;5(1):e000581. 7. Groves DS, Welsby IJ, Naik BI, et al. Multicenter evaluation of the Quantra QPlus System in adult patients undergoing major surgical procedures. Anesth Analg. 2020;130(4):899-909. 8. Winegar DA, Viola F. Is the Quantra QPlus system easy to interpret? American Association of Clinical Chemistry (AACC) Annual Scientific Meeting, Virtual Congress, December 13-17, 2020. 9. Winegar DA, Gillespie C, Sanchez-Illan M. Improving the interpretation of viscoelastic test results in the critical care setting. American Association of Clinical Chemistry (AACC) Annual Scientific Meeting, July 24-28, 2022. 10. Leadbetter NH, Givens TB, Viola F. Unique approach to quality assurance in viscoelastic testing. J Appl Lab Med. 2020;5(6):1228-1241. 11. Ferrante EA, Blasier KR, Givens TB, Lloyd CA, Fischer TJ, Viola F. A novel device for the evaluation of hemostatic function in critical care settings. Anesth Analg. 2016;123(6):1372-1379. 12. DeAnda A, Levy G, Kinsky M, et al. Comparison of the Quantra QPlus System with thromboelastography in cardiac surgery. J Cardiothorac Vasc Anesth. 2021;35(4)1030-1036. 13. Naik BI, Durieux ME, Knisely A, et al. SEER sonorheometry versus rotational thromboelastometry in large volume blood loss spine surgery. Anesth Analg. 2016;123(6):1380-1389. 14. Huffmyer JL, Fernandez LG, Haghighian C, Terkawi AS, Groves DS. Comparison of SEER sonorheometry with rotational thromboelastometry and laboratory parameters in cardiac surgery. Anesth Analg. 2016;123(6):1390-1399. 15. Reynolds PS, Middleton P, McCarthy H, Spiess BD. A comparison of a new ultrasound-based whole blood viscoelastic test (SEER sonorheometry) versus thromboelastography in cardiac surgery. Anesth Analg. 2016;123(6):1400-1407. 16. Baryshnikova E, Di Dedda U, Ranucci M. A comparative study of SEER sonorheometry versus standard coagulation tests, rotational thromboelastometry, and multiple electrode aggregometry in cardiac surgery. J Cardiothorac Vasc Anesth. 2019 ;33(6):1590-1598. 17. Quantra System IT and Networking Guide. HemoSonics, LLC. 18. Quantra Desktop Remote Viewer Instructions for Use (IFU). HemoSonics, LLC. 19. Ranucci M, Baryshnikova E. Sensitivity of viscoelastic tests to platelet function. J Clin Med. 2020; 9(1):189.
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