Accriva Diagnostics Product Guide · Accriva Diagnostics is an organization with a passion and energy for helping healthcare professionals find answers in some of the most critical

Accriva Diagnostics Product GuideA C C U R A C Y I S I N O U R B L O O D

More than a company, a partner in health care.

Accriva Diagnostics is an organization with a passion and energy for helping healthcare professionals

find answers in some of the most critical hospital settings.

We are dedicated to providing best-in-class diagnostics and our innovations in instrumentation,

software and assays have made us a leader in Point-of-Care.

In this product guide, you will find our wide range of products supporting multiple departments and

specialties in healthcare systems around the globe. Our proven solutions help support actionable

treatment decisions by medical professionals and better outcomes for their patients.

A Commitment to Quality

At Accriva, we are committed to setting the standard for quality in our industry.

In our Corporate Quality Policy, we emphasize continuously improving customer satisfaction and

company value by designing, producing and delivering the highest quality products and services.

Each employee has a responsibility to foster continuous improvement, maintain regulatory compliance,

and ensure quality system effectiveness.

Technical SupportAccriva supports our customers with a world-class Technical Support team made up of clinicians and scientists with expertise in Accriva’s instruments, tests, and software. You can reach Technical Support by:

Phone: +1.800.579.2255 (toll-free) or +1.858.263.2502 (outside North America)

Email: [email protected]

Fax: +1.858.314.6700

How to OrderThere are three simple ways to place your order:

Email: [email protected]

Phone: +1.800.643.1640 (toll-free) or +1.858.263.2501 (outside North America)

Fax: +1.858.314.6701

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© 2016 Accriva Diagnostics, Inc. All rights reserved.

Accriva, Hemochron, HepCheck, directCheck, VerifyNow, Avoximeter, OxyReview, Tenderfoot, Softsweep, Tenderlett and Surgicutt are registered trademarks or trademarks of Accriva. All other brands and names contained herein are the property of their respective owners.

Cardiac Cath LabACT+; ACT-LR;

APTT; PTPgs. 5 - 10

PRU; Aspirin; IIb/IIIaPgs. 15 - 20

%HbO2; tHb; O2Ct

Pgs. 21 - 24

Cardiovascular OR ACT+Pgs. 5 - 10

PRU; AspirinPgs. 15 - 20

SurgicuttPg. 28

Coagulation Clinic PTPgs. 5 - 10


TenderlettPg. 28

Critical Care UnitACT+; ACT-LR;

PT; APTTPgs. 5 - 10


%HbO2; COHb; MetHb

Pgs. 21 - 24

Emergency Department PT; APTTPgs. 5 - 10


%HbO2; COHb; MetHb

Pgs. 21 - 24

General Surgery PT; APTTPgs. 5 - 10


SurgicuttPg. 28

Interventional Radiology/ Neuroradiology

ACT-LR; PTPgs. 5 - 10

PRU; Aspirin; IIb/IIIaPgs. 15 - 20

Laboratory Services PRU; AspirinPgs. 15 - 20

%HbO2; COHb; MetHb

Pgs. 21 - 24

TenderlettPg. 28

Neonatal ICUACT-LR;

APTTPgs. 5 - 10

MetHbPgs. 21 - 24

Micro-Preemie; Preemie; NewbornPgs. 26 - 27

Outpatient Surgery ACT-LR; APTT; PTPgs. 5 - 10


SurgicuttPg. 28

Pulmonary Function Lab COHbPgs. 21 - 24

The product selector guide provides an at-a-glance view of Accriva’s systems and products supporting key hospital departments. For your convenience, page numbers indicating where more information can be found are listed next to each product.

At-a-Glance Product Selector by Hospital Department

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Hemochron® Coagulation Monitoring Systems

Hemochron Signature Elite System . . . . . . . . . . . . . . . . . . . . . . . . . PAGE 5

• Hemochron Signature Elite Instrument

• Hemochron Signature Elite System Accessories

• Hemochron Activated Clotting Time (ACT+)

• Hemochron Activated Clotting Time Low Range (ACT-LR)

• Hemochron Activated Partial Thromboplastin Time (APTT)

• Hemochron Citrate Activated Partial Thromboplastin Time (Citrate APTT)

• Hemochron Prothrombin Time (PT)

• Hemochron Citrate Prothrombin Time (Citrate PT)

• directCheck Controls for Hemochron Signature Elite Tests

Hemochron Response System . . . . . . . . . . . . . . . . . . . . . . . . . . . PAGE 11

• Hemochron Response Instrument

• Hemochron Response System Accessories

• Glass Particulate Activated ACT

• Celite® Activated Clotting Time (ACT)

• Kaolin Activated Clotting Time (ACT)

• Glass Particulate Activated ACT

• Heparin Response Test (HRT)

• Protamine Response Test (PRT)

• Protamine Dose Assay (PDAO)

• Whole Blood Quality Controls for Response Tests

Contents

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VerifyNow® Platelet Reactivity System

VerifyNow System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PAGE 15

• VerifyNow Instrument

• VerifyNow System Accessories

• VerifyNow PRUTest®

• VerifyNow Aspirin Test

• VerifyNow IIb/IIIa Test

• Controls for VerifyNow

Avoximeter® Whole Blood Oximeter and CO-Oximeter Systems

Avoximeter 1000E Whole Blood Oximeter . . . . . . . . . . . . . . . . . . . . . . PAGE 21

Avoximeter 4000 Whole Blood CO-Oximeter . . . . . . . . . . . . . . . . . . . . . PAGE 21

• Avoximeter System Accessories

• Cuvettes for Avoximeter

• Controls for Avoximeter

Accriva Blood Collection Incision Devices

Tenderfoot ® Heel Incision Device . . . . . . . . . . . . . . . . . . . . . . . . . . PAGE 26

• Tenderfoot Newborn

• Tenderfoot Preemie

• Tenderfoot Micro-Preemie

• Tenderfoot Toddler

Tenderlett® Finger Incision Device . . . . . . . . . . . . . . . . . . . . . . . . . . PAGE 28

Surgicutt® Bleeding Time Device . . . . . . . . . . . . . . . . . . . . . . . . . . PAGE 28

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Hemochron® – POC Coagulation Monitoring

Health systems have relied on the accuracy of the Hemochron Point-of-Care (POC) system for over 40 years. The Hemochron product family continues to be at the forefront of coagulation monitoring, providing solutions for modern compliance, quality and connectivity requirements, ideal for the wide variety of applications found in today’s busy health care industry.

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Trusted in Point-of-Care (POC) settings around the world, the Hemochron Signature Elite provides clinicians with a portable, easy-to-use system for monitoring patients on anticoagulant therapy. It’s the preferred POC solution because of its simple and standardized test procedure that may reduce user variability.

Hemochron Signature Elite: Whole Blood Microcoagulation System

Highlights:

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Ordering Information

System Accessories

Catalog Number Description Quantity

ELITE Hemochron Signature Elite Whole Blood Microcoagulation System 1 each


PKIT Printer Kit for use with Hemochron Signature Elite. Includes 1 printer, 1 battery, 1 connector cable, 1 AC adapter and 5 roles of paper.

1 each

RP-DPU Replacement printer paper. 5 rolls/box

HE-LP Linearity and precision testing performance by Accriva technicians. 1 each

RPM-CD Report Maker™ - Data management software package for use with Hemochron Signature Elite. Prints patient and QC data by using Crystal Report™. Can generate Levy Jennings charts for QC reporting. Includes PCKIT

1 each

PCKIT RS232 compatible cable for downloading the Hemochron Signature to a PC. Includes downloading instructions.

1 each

• RapidCount Technology – Accelerated ACT+ test (up to 4.5 minutes)

• True End-Point Clot Detection – Actually reflects fibrin formation

• Broad Test Menu – Standardizes coagulation monitoring throughout the hospital

• Integrated Barcode Scanner – Provides audit trails for patient, operator and test criteria

• Compliance Features – Includes QC, OID lockout, and more to ease regulatory challenges

• Data Management – Connects to RALs, Telcor, Conworx and others

Hemochron – POC Coagulation Monitoring

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Exclusive Features of the Hemochron Signature Elite

Detects A True End-Point Clot That Reflects Fibrin Formation

Fastest ACT+ Test Using RapidCount Technology

Stable Fibrin Clot

Hemochron Signature Elite

Detects Clots Here

Factor Xa

C O M M O N PAT H W AY:

Fibrin

ThrombinProthrombin

Fibrinogen

Signature Elite ACT+ Target Time

~4.5 MinAchieved in

Compared to

The Fastest ACT+ Count

~8 MinWith Other ACT+ Methods

Hemochron Signature Elite offers the industry’s most extensive point-of-care test menu for rapid coagulation management. This includes accelerated high-range ACT (ACT+), low-range ACT (ACT-LR), PT, APTT, citrated PT and citrated APTT. Easy-to-read and rapid results allow for immediate dose adjustments instead of waiting on lab results.

Broad POC Coagulation Test Menu

Highlights:

• Broad Test Menu – Standardizes coagulation monitoring throughout the hospital

• Cuvette Based Technology that measures to the laboratory standard of fibrin formation

• No Sample Preparation or measuring required

• Barcode Labeled for accurate test information transcription (Lot No., Expiry Date, Test Type)

• Optional Room-Temperature Storage for added convenience (see product package insert for details)

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Catalog Number Description Quantity Shipping Conditions

Storage Temperature

JACT+ Hemochron ACT+ test cuvette – Silica and kaolin based activated clotting time test for use with fresh whole blood. Monitors moderate to high levels of heparin (1-6unit/mL)

45 cuvettes/box

Room Temperature

2-8°C

JACT-LR Hemochron ACT-Low Range test cuvette – Celite® based activated clotting time test for use with fresh whole blood. Monitors low to moderate levels of hep-arin (up to 2.5 units/mL)

45 cuvettes/box

Room Temperature

2-8°C

J201 Hemochron PT test cuvette – Prothrombin time test cuvette for use with fresh whole blood (venous or fingerstick sampling)

45 cuvettes/box

Room Temperature

2-8°C

J201C Hemochron Citrated PT test cuvette – Prothrombin time test cuvette for use with citrated whole blood

45 cuvettes/box

Room Temperature

2-8°C

J103 Hemochron APTT test cuvette – Activated Partial Thromboplastin time test for use with fresh whole blood. For evaluating of low dose heparin (up to 1.5 unit/mL)

45 cuvettes/box

Room Temperature

2-8°C

J103C Hemochron APTT test cuvette – Activated Partial Thromboplastin time test for use with Citrated whole blood. For evaluating of low dose heparin (up to 1.5 unit/mL)

45 cuvettes/box

Room Temperature

2-8°C


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Accriva offers flexible, scalable solutions for data management and connectivity for all Hemochron point-of-care devices.

A data management system for documenting, tracking, and managing patient and QC test results efficiently from all Hemochron devices.

Exclusive software for the Hemochron Signature Elite instrument used to configure the operational and compliance settings. Easily clone multiple instruments with the same setting or have each with their own unique configuration.

Specific to Hemochron Response, The Data Manager software is used to configure the operational and compliance settings required by the POC setting.

Data Management and Connectivity

Hemochron Report Maker

Configuration Manager

Data Manager

Connectivity

Hemochron instrument connectivity to leading data management system providers in the industry.

Accriva Instrument RALS®-Web 3 Aegis POC™ PWeb®/SYBASE®

Conworx UniPOC®

TELCOR QML®

Hemochron Signature Elite Yes Yes No Yes Yes

Hemochron Response Yes Yes No Yes Yes

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For each Signature Elite test type, Accriva offers two levels of liquid quality controls that can be used to maintain quality assurance directives in your setting. Each directCHECK quality control is used to evaluate system performance of each test type by assessing that it meets the expected analytical range.

directCheck® Quality Controls

Highlights:



Storage Temperature

DCJACT-N Normal level vials – For use with ACT+ Test Cuvettes. Includes 4 protective sleeves.

15 vials/box Coldpack 2-8°C

DCJACT-A Abnormal level vials – For use with ACT+ Test Cu-vettes. Includes 4 protective sleeves.


DCJLR-N Normal level vials – For use with ACT-LR Test Cuvettes. Includes 4 protective sleeves.


DCJLR-A Abnormal level vials – For use with ACT-LR Test Cuvettes. Includes 4 protective sleeves.


DCJPT-N Normal level vials – For use with PT Test Cuvettes. Includes 4 protective sleeves.


DCJPT-A Abnormal level vials – For use with PT Test Cuvettes. Includes 4 protective sleeves.


DCJCPT-N Normal level vials – For use with Citrate PT and Citrate APTT Test Cuvettes. Includes 4 protective sleeves.


DCJCPT-A Abnormal level vials – For use with Citrate PT Test Cuvettes. Includes 4 protective sleeves.


DCJCAPTT-A Abnormal level vials – For use with Citrate APTT Test Cuvettes. Includes 4 protective sleeves.


DCJAPTT-N Normal level vials – For use with APTT Test Cuvettes. Includes 4 protective sleeves.


DCJAPTT-A Abnormal level vials – For use with APTT Test Cuvettes. Includes 4 protective sleeves.


• Dried Whole Blood Format mimics patient testing

• Rapid and Easy To Use - applies the same learning curve as running real samples

• Provided With Protective Sleeves, used for crushing vials

• Optional Room-Temperature Storage for added convenience (see product package insert for details)


The classic dual-well testing instrument offers an extensive test menu for monitor-ing anti-coagulation therapy. The system offers Operator Identification, Operator Lockout, QC lockout, Data storage up to 600 patient results per well, and up to 64 QC results per well. Combined with the RxDx® Dosing system module, it can provide information for patient dosing, leading to improved outcomes and improved blood utilization.

Hemochron Response: Whole Blood Coagulation System

Highlights:

• Gold standard ACT Tube Technology provides confidence in results

• Convenience of a Comprehensive ACT Test Menu

• Dual Test Well Capability For Heparin Dosing Protocols and improved patient management

• RxDx Dosing system provides patient dosing information

• Enhanced Data Management Features to assist with regulatory compliance



HRS.110 Hemochron Response Whole Blood Coagulation System and integrated printer. 1 each

RXDX Analysis Module for Heparin and Protamine Dosing. 1 each

System Accessories


HRDM3CD Hemochron Response Data Manager - Software package to enable the Hemochron Response to a PC.

1 each

HR-CBL Hemochron Response Cable/Connectors – Cable replacement for downloading the Hemochron Response to a PC. Designed to be used with the HRDM software.

1 each

HE-ESV Electronic Quality Control for Hemochron Response instruments 1 each

HR1003 Digital temperature verification test tube 1 each

HRP-5 Thermal Printer paper 5 Rolls/Box

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The Hemochron Response Coagulation System offers a full range of ACT tubes for every level of heparin anticoagulation. These tests may be performed at bedside where the blood sample is drawn directly into a test tube or is transferred via syringe.

ACT Tube Tests

Highlights:



Storage Temperature

P214 Flip-top glass test tube with glass beads, recom-mended ACT for low to moderate heparin monitoring

95 Tubes/Box

Room Temperature

15-30°C

HRFTCA510 Flip-top non-evacuated glass test tube with diatomaceous earth (Celite), recommended ACT for high heparin monitoring

95 Tubes/Box

Room Temperature

15-30°C

HRFTK-ACT Flip-top non-evacuated glass test tube with Kaolin, recommended ACT for high heparin monitoring

95 Tubes/Box

Room Temperature

15-30°C

• Flip-Top Tubes allow needleless blood transfer

• Requires 0.4 to 2.0 CC of Fresh Whole Blood (depending on test)

• Barcoded Tubes - Provides audit trails for patient, operator and test criteria

• Convenience of Storing at Room Temperature

• Available with Diatomaceous Earth (Celite) or Kaolin Based Activators

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The RxDx Dosing System offers a full range of tubes for assessing heparin and protamine dose response in addition to protamine dose determination.

RxDx Anticoagulation Tubes

Highlights:

• Available with Diatomaceous Earth (Celite) or Kaolin Based Activators

• Convenience of storing at room temperature

• Protamine Response Test available for testing low-moderate and moderate-high heparin dosing

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Storage Temperature

R-HRT480P Heparin Response Test – Celite Based 40 tubes/box

Room Temperature

15-30°C

R-HRT480PK Heparin Response Test – Kaolin Based 40 tubes/box

Room Temperature

15-30°C

R-PRT200 Protamine Response Test – Celite. For Low to Moderate Levels of Heparin

40 tubes/box

Room Temperature

15-30°C

R-PRT200K Protamine Response Test – Kaolin. For Low to Moderate Levels of Heparin

40 tubes/box

Room Temperature

15-30°C

R-PRT400 Protamine Response Test – Celite. For Moderate to High Levels of Heparin

40 tubes/box

Room Temperature

15-30°C

R-PRT400K Protamine Response Test – Kaolin. For Moderate to High Levels of Heparin

40 tubes/box

Room Temperature

15-30°C

PDAO Protamine Dose Assay - Celite 40 tubes/box

Room Temperature

15-30°C

PDAOK Protamine Dose Assay – Kaolin 40 tubes/box

Room Temperature

15-30°C

Whole Blood Quality Controls

Highlights:



Storage Temperature

QCACT Whole Blood Control for use with Hemochron Kaolin and Celite ACT test tubes.

10 vials of level 1 & 2

/box

Cold Packs 2-8°C

RQCHRT Whole Blood Control for use with Heparin Response Tubes (R-HRT480P and R-HRT480PK).

10 vials of level 1 & 2/box

Cold Packs 2-8°C

RQCPRT Whole Blood Control for use with Protamine Response tubes (R-PRT200, R-PRT200K, R-PRT400, R-PRT400K, PDAO and PDAOK).

10 vials of level 1 & 2

/box

Cold Packs 2-8°C

DCP214-N HepCheck® Normal Whole Blood Control for use with P214 test tubes.


Cold Packs 2-8°C

DCP214-A HepCheck Abnormal Whole Blood Control for use with P214 test tubes.


Cold Packs 2-8°C

• One QC Product for All Protamine Response Tubes, includes 2 levels of controls

• One QC Product for all Heparin Response Tubes, includes 2 levels of controls

• One QC Product for Kaolin and Celite ACT Tubes, includes 2 levels of controls

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The Hemochron Whole Blood Quality Controls are intended to be used to perform quality control assays using the Hemochron ACT and RxDx Anticoagulation Tubes.

VerifyNow® Platelet Reactivity System

Data show that at least 1 in 3 patients on antiplatelet medications may not receive the expected antiplatelet effect.1-3

Patients with inadequate response to their antiplatelet medications may be at significantly greater risk of myocardial infarction, stent thrombosis and death, while patients with hyper-response to their antiplatelet medications may be at risk of bleeding.4-7

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Rapid, Easy, Proven AssessmentVerifyNow is a widely used, FDA-cleared platelet reactivity test available to help identify patients at risk of a major adverse event due to poor drug response.

Regular use of VerifyNow testing can help to identify patients who may be either hyper- or nonresponders to common antiplatelet medications such as clopidogrel or even aspirin.

The VerifyNow System

PAGE 16

VerifyNow testing is an important tool for better patient management among clinical leaders across the healthcare system, including:

VerifyNow Testing Supports Better Patient Management

• Cardiology

• Surgery

• Anesthesiology

• Neurology

• Interventional Radiology & Neuroradiology

• Trauma

• Emergency Department

• Blood Utilization

• Pharmacy

• Physician Office Lab

1 Gurbel P, et al. J Am Coll Cardiol. 2007;50(19):1822-34. 2 Krasopoulos W, et al. BMJ. 2008;336(7637):195-8. 3 Steinhubl SR, et al. Circulation. 2001 May 29;103(21):2572-8.

4 Patti G, et al. J Am Coll Cardiol 2008;52:1128-33. 5 Marcucci R, et al. Circulation 2009;119(2):237-42. 6 Cuissett, T. et al. Am J Cardiol 2008 Jun 15;101(12):1700-3.

7 Price, MJ. et al. Eur Heart J 2008 Apr;29(8):992-1000.

What Physicians Say About VerifyNow Testing:I test all patients on platelet inhibitors prior to open heart surgery to assess whether or not antiplatelet therapies are having their desired effect.”

Pierre R. Tibi, MDCardiovascular Surgeon

Having the VerifyNow system allows me to assess the effect of the chosen antiplatelet treatment strategies and make informed decisions.”

J. Brent Muhlestein, MDInterventional Cardiologist

Testing with VerifyNow supports ongoing expansion of the frontiers of endovascular aneurysm treatment by helping minimize risk of perioperative complications.”

Josser E. Delgado, MDNeurointerventionalist

“

“

“

VerifyNow Platelet Reactivity System

PAGE 17

Surgical Blood Management Protecting Against Thromboembolic Complications in Neurovascular InterventionThe overwhelming body of evidence is clear

that the reduction in platelet activity due to antiplatelet therapies increases the risk of perioperative bleeding. Additionally, the evidence has demonstrated that there is a wide variability in how patients respond to these medications, with a large percentage of patients never receiving the expected effect and often referred to as “non-responders”. Having a tool like the VerifyNow System, allows me to quickly and accurately measure platelet activity and then make informed decisions regarding timing of surgeries as well as when they are needed post-surgically. ”

Pierre R. Tibi, MDDirector of Cardiothoracic SurgeryYavapai Regional Medical Center

Antiplatelet therapies play a critical role in protecting our patients from thromboembolic complications that can cause significant and long term adverse events. We learned early on that patients have a wide variability in how they respond to these medications and that the level of response may play a significant role in the experience of periprocedural thrombotic events. With the availability of platelet reactivity testing, we can assess the level of effect of the standard antiplatelet regimen prior to the intervention and consider alternative treatment strategies if necessary.”

Demetrius K. Lopes, MDAssociate Professor of Neurosurgery and Radiology Rush Medical Center

We Asked Physicians a Simple Question: Why Do You Test?

““

PAGE 18

Highlights:


System Accessories


86000 VerifyNow System, with Operator’s Manual, AC adapter and Cord 1 each


85062 Preventative Maintenance Kit. 13 cleaning devices & 1 fan filter per box 1 box

85021 VerifyNow Printer 1 each

85022 Printer Paper 10 rolls/box

70068 EQC Device 1 each

37056 Fan Filter 1 each

37060 Fan Retainer 1 each

15097 Lithium Heparin Tubes 50/rack

15098 Sodium Citrate Tubes 50/rack

16011 Sodium Citrate Tubes High Altitude 50/rack

VerifyNow testing provides a rapid, easy and accurate way to measure antiplatelet drug response, providing the right information to:

• Identify patients at risk for an antiplatelet-related bleeding or thrombotic event

• Measure the effect of antiplatelet therapies prior to discharge

• Optimize patient length-of-stay prior to surgery

• Help reduce 30 day readmissions

• Help improve overall patient outcomes

VerifyNow Platelet Reactivity System

PAGE 19

VerifyNow Test Kits feature self-contained, single-use cartridges that measure platelet reactivity as a function of increased light transmission through whole blood as platelets are activated by these antiplatelet agents. There are three single-use test kits available which measure platelet response to commonly used antiplatelet agents. All three tests are designed to assess platelet function based on the ability of activated platelets to bind fibrinogen.

VerifyNow Test Kits

The VerifyNow PRUTest is designed to measure platelet P2Y12 receptor blockade. Substances known to specifically block the P2Y12 receptor include the thienopyridine class of drugs, including clopidogrel (Plavix®). The PRUTest measures P2Y12 receptor mediated platelet aggregation. Test results are not influenced by non-specific platelet aggregation mediated through P2Y1. To accomplish this, the VerifyNow PRUTest uses an additive (PGE1) in addition to ADP to make the test more sensitive and specific for the effects of ADP mediated by the P2Y12 receptor. Results are reported in P2Y12 Reaction Units (PRU).

Measures platelet response to aspirin, which affects platelet function by irreversibly inhibiting the cyclooxygenase-1 (COX-1) enzyme involved in the conversion of arachidonic acid to thromboxane A2, which ultimately activates the GP IIb/IIIa receptors involved in platelet aggregation. Results are reported in Aspirin Reaction Units (ARU).

Measures platelet response to GP IIb/IIIa inhibitors, such as abciximab (ReoPro®) and eptifibatide (Integrilin®). Results are reported in Platelet Aggregation Units (PAU).

VerifyNow PRUTest® VerifyNow Aspirin Test

VerifyNow IIb/IIIa Test

Blood SampleShowing Inhibition of

Platelet Function

Red Blood Cells

Fibrinogen-Coated Beads

Low LightTransmittance

Platelet-BeadAggregates

Blood SampleShowing NormalPlatelet Function

Increased LightTransmittance

Platelets

Agonist

PAGE 20


Controls and Reagents


Storage Temperature

85225 VerifyNow PRUTest Kit 25 tests per box

15-25°C 15-25°C

85053 VerifyNow Aspirin Test Kit 25 tests per box

2-25°C 2-25°C

85053-10 VerifyNow Aspirin Test Kit 10 tests per box

2-25°C 2-25°C

85310 VerifyNow IIb/IIIa Test Kit 10 tests per box

18-25°C 18-25°C


Storage Temperature

85047 VerifyNow WQC Kit 6 each 15-25°C 15-25°C

Highlights:

A fully contained test system which uses a patented, LTA-correlated technology that is safe, accurate and intui-tive to use. VerifyNow testing supports better patient management.

• Report platelet reactivity results in minutes

• Require no pipetting or sample preparation

• Provide information that can improve patient management

Avoximeter – POC Oximetry and CO-Oximetry Monitoring

The Avoximeter line of Oximeters (1000E) and CO-Oximeters (4000) has long been the standard in point-of-care diagnostics when it comes to oxygen saturation, carbon monoxide levels and Methemoglobin assessments. The Avoximeter has been ideally suited for a variety of hospital departments for over 20 years.

Today’s clinicians seek technology that helps to provide a more accurate diagnosis during cardiac catheterization procedures. The portable Avoximeter 1000E measures total hemoglobin, oxyhemoglobin fraction and computes oxygen saturation in less than 10 seconds.

The portable Avoximeter 4000 provides rapid, accurate assessment of the patient’s true oxygenation status at the bedside. Whether used in the ER to assess carbon monoxide toxicity, the NICU to confirm the presence of Methemoglobin as a result of nitric oxide therapy or other critical care applications, the Avoximeter 4000 offers a more comprehensive and complete evaluation to enable critical decisions and treatments within seconds.

PAGE 21

Avoximeter Instrument Systems

Highlights:



AVOX1000E Avoximeter 1000E System w/ Power Supply 100-240V um: Operator’s manual, AC adapter, cord, optical filters and one year of warranty service

1 each

AVOX4000 Avoximeter 4000 System w/ Power Supply 100-240V um: Operator’s manual, AC adapter, cord, optical filters and one year of warranty service

1 each

System Accessories


AVOXPRNT Printer for Avox 1000E & 4000 1 each

AVOXROLL Printer paper 54mm 1 roll

• The only POC oximeter allowed in Cath Labs according to the CLSI Guidelines1

• Simple 2 step method - inject 50µl sample into cuvette, then insert cuvette into instrument

• Data management - connects to RALs, Telcor, Aegis POC and OxyReview™

• No sample preparation - uses whole blood

• Fast - results in less than 10 seconds

• Easy to read - results displayed on an illuminated liquid crystal display screen

PAGE 22

1 Blood Gas and pH Analysis and Related Measurements. (2010). CLSI Guidelines, 29(8), 6-7

Avoximeter – POC Oximetry and CO-Oximetry Monitoring

PAGE 23

With the Avoximeter, there is no need for sample preparation as the system can analyze fresh whole blood, heparinized blood and EDTA. The cuvettes themselves also require no preparation as they incorporate a closed cuvette system.

Optical Controls

Provided with the Avoximeter are a set of opti-cal filters to be used once a day that ensure the optics are clean, calibrated and ready to be used in patient diagnostics.

Liquid Quality Controls (LQC)

Accriva recommends that LQC be performed at least once a week using 1 level. Every hospital has different QC protocols. Please refer to your organization’s procedures.

Avoximeter Tests and Accessories

Highlights:

• No sample preparations required

• No on-board system fluid or waste

• Disposable, easy to fill cuvette

• Room temperature cuvette storage

• Extensive shelf life

• Results in less than 10 seconds

PAGE 24



Storage Temperature

C100B Cuvette. (AVOX1000E) 100 cuvettes/box

Room Temperature

Room Temperature

QV8 Cuvette. (AVOX4000) 100 cuvettes/box

Room Temperature

Room Temperature

Accriva recommends purchasing Liquid Quality Controls (LQC) through RNA Medical. You can order online by visiting their website www.RNAMedical.com or contact RNA directly at 800-533-6162.


Advanced Engineering Defines our Incision Line

Double Honed BladeOur incision products provide the only double honed blade on the market. With single honed blades, the bevel is considerably thinner. This reduced tensile strength can lead to the edge curling, which causes a jagged incision and increased bruising at the site. Double honed blades use the upper bevel as a taper, adding strength to the spine of the cutting edge. This strength carries through to the sweeping motion creating a clean surgical incision and faster healing time.

Our patented technology has long been sought after by others on the market for its considerate engineering meant to appeal to all parties of the heel stick testing process. As the leading incision device, and the only one made in America, our Quality and Manufacturing Engineers have examined every single part for improved performance. From its heavy gauge steel spring creating a fast and strong sweep to its ergonomic shape.

Patented Softsweep™ DevicesOur patented Softsweep devices perform a gentle, sweeping arc incision above the level of sensitive nerve fibers. Our devices are safe, easy to use, and virtually pain free with less bruising as compared with traditional lancet devices, resulting in a sample with maximum blood flow to reduce the need for re-sticking.

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Softsweep Traditional Lancet

Tenderfoot Comparative ResultsOur one of a kind incision products combine the precision of a surgical cut with our patented technology, causing the blade to move in a smooth arcing motion compared to devices that puncture at a 90-degree angle. The quality of the Tenderfoot incision ensures less trauma and a higher caliber of blood sampling. The puncture method consequently leads to a significant reduction of the vasoconstriction caused by pain due to insufficient blood volume.1 The smooth incision across the capillary bed does not penetrate into the nerve fibers, leaving the baby with minimal pain and bruising. This greatly speeds up the healing process. By cutting across the capillary bed, instead of stabbing down into the capillaries, Tenderfoot increases the surface area and creates more blood flow requiring no painful squeezing of the heel, which can alter the chemical properties of the blood sample.

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Using Tenderfoot Traditional Lancet

Summary of Clinical Outcome

A safe and effective method for obtaining blood samples from the heels of infants. The Tenderfoot® comes in four sizes to offer a custom fit to any baby’s heel from micro-preemies to toddlers. The result is a gentle surgical cut that is controlled to a depth just above most nerve fibers, cutting across the capillary bed.

1 Skin Conductance and the Stress Response From Heel Stick in Preterm Infants. (2000). Archives of Disease in Childhood: Neonatal Edition, 83(2).


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Tenderfoot Heel Incision Device



TF50I Tenderfoot; Newborn (2500g-9kg); Incision (depth/length) 1.00 mm/2.50 mm. 50/box



TFP50I Tenderfoot; Preemie (1000g-2500g); Incision (depth/length) 0.85 mm/1.75 mm. 50/box



TFM50I Tenderfoot; Micro-Preemie (<1000 grams); Incision (depth/length) 0.65 mm/1.40 mm. 50/box

TFT50I Tenderfoot; Toddler (>9kg); Incision (depth/length) 2.00 mm/3.00 mm. 50/box

Highlights:

• Patented Softsweep design

• Blade sweeps across capillary bed avoiding the nerve fibers

• Maximum blood flow reducing the need for re-sticks or excessive squeezing

• Faster healing time and less bruising when compared to traditional lancets

• Blade permanently retracts eliminating any chance of accidental sticks

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Tenderlett Finger Incision DeviceA finger incision device designed to fit the contour of the finger. It comes available in a standard size to accommodate older children to adults. This creates a uniform length and depth with every procedure.

Surgicutt Bleeding Time DeviceA bleeding time device used to screen for platelet function by using the Ivy Method. This all-in-one bleed time test also comes available with individually pouched blotting paper to wick away residual blood.


TL100I Tenderlett; Finger stick; Adults/older children; Incision (depth/length) 1.75 mm/0.94 mm.

100/box

TL5000I Tenderlett; Finger stick; Adults/older children; Incision (depth/length) 1.75 mm/0.94 mm.

5000/box


SU50I Surgicutt; Adult; Incision (dep h/length) 1.00 mm/5.00 mm. 50/box

SUP100I All Ages; Blotting Paper; 9.0 cm diameter. 100/box

Tenderlett®

Finger Incision Device

Surgicutt®

Bleeding Time Device

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Notes:

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A C C U R A C Y I S I N O U R B L O O D

Accriva Diagnostics, Inc. | 6260 Sequence Drive | San Diego, CA 92121 USA

Tel: 858.263.2300 | Toll-Free: 800.631.5945 | www.accriva.com

To learn more, visit www.accriva.comUS Customers: 800.643.1640International Customers: [email protected]

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