ACL TOP 550 CTS_ACL TOP50 Series_EN.pdf

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Introducing The most advanced systems in Hemostasis testing.

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The new ACL TOP Family 50 Series is designed to minimize errors and enhance quality.

New ACL TOP Family 50 Series Offering the most advanced automation and quality management from routine to specialty assays.

Standardized across all ACL TOP systems—for superior performance across your entire testing process

• Same quality results

• Same comprehensive reagent portfolio

• Same powerful and intuitive software

• Same features and usability

And now:

• Same assay-specific pre-analytical sample checks

• Same advanced lab accreditation support

• Same advanced quality management

A breakthrough in Hemostasis testing.

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For high-volume labs

For medium- to high-volume labs

For medium-volume labs

Completely standardized for advanced automation and quality Ideal for medium- to high-volume labs, including integrated lab automation systems—routine or specialty testing.

ACL TOP 750

Runs more tests in less time—user-friendly and high-throughput for routine analysis in laboratories with the heaviest workloads.

ACL TOP 750 CTS

Closed-Tube Sampling adds safety in routine, high-volume and specialty labs.

ACL TOP 750 LAS

Connects to laboratory automation tracks for maximum flexibility and efficiency.

ACL TOP 750 ACL TOP 750 CTS

Throughput (PT/hr) up to 360 up to 270

Samples onboard 120 120

Reagents onboard 60 60

ACL TOP 550 CTS

For highly automated testing in routine, medium- to high-volume and specialty labs.

Throughput (PT/hr) up to 240

Samples onboard 80

Reagents onboard 40

ACL TOP 350 CTS

The most compact ACL TOP Family 50 Series system for routine or specialty assays in medium-volume labs. Perfect companion to ACL TOP 750 CTS and 550 CTS systems.

Throughput (PT/hr) up to 110

Samples onboard 40

Reagents onboard 26 t

Onboard barcode reader allows real-time reagent management.

Closed-Tube Sampling enhances safety in the testing process.

Analyzer automation

• Barcoded reagents

• Continuous onboard reagent-stability monitoring

• Automatic QC frequency execution

• Rerun and reflex testing capabilities

• Fully automated reporting of factor assays with parallelism

• Auto-verification and uploading of results

• Closed-Tube Sampling via cap-piercing (CTS models only)

Continuous operation

• Continual loading and unloading of samples and reagents via racks with no system interruption

• Uninterrupted cuvette loading and waste disposal

Simple maintenance

• Daily maintenance, ordered by user and performed by system, in < 5 minutes

• “Maintenance overdue” notifications to alert user

• Remote instrument diagnostics and troubleshooting via web in real time* (optional)

Laboratory automation

• Follows CLSI Guidelines (AUTO 1–5) for true “Point-of-Reference” sampling

• Open system compatible with most laboratory automation track systems

• Eliminates need for costly and slow robotic interface

Fast turnaround

• Up to 360 PT/hr

• PT results from standby in approximately 3 minutes

• Samples loaded on any rack, in any position, at any time, including STAT

* Not available in all countries.

The ACL TOP Family t5

The ACL TOP Family 50 Series

Automated pre-analytical sample integrity checks

• Detects interference from Hemolysis, Bilirubin or Lipemia

- Values exceeding assay-specific thresholds are flagged

- Pre-set to validated thresholds with optional customization

• Detects tube-fill height issues

• Flags abnormal sample aspiration, prompting user to check for clots

Advanced quality and accreditation support tools

• Most comprehensive set of audit-trail tools available

• Time, date and operator stamps for all analyzer functions and activity

• Maintenance, QC and calibration logs, and temperature report

• Comprehensive and secure one-click audit reports

Enhanced system security

• Second-level password and electronic signature

• Automatic system log-off

• System-access restriction with user-specific log-in and password

• Automatic password expiration

• Comprehensive 21 CFR Part 11 support tools

• Optional user-access restriction to patient-demographic information t5 t

HemosIL assays ACL TOP Family 50 Series systems are optimized to operate with a comprehensive panel of HemosIL assays. Together, they are a complete disease-state management solution. Innovative HemosIL assays, routine to specialty, help guide pathways for better patient care that can reduce costs associated with hospital length-of-stay and therapeutic management.

True standardization throughout the lab for routine and specialty assays on all ACL TOP systems

Comprehensive assay menu for disease state management

Increased efficiencies with HemosIL liquid, ready-to-use assays

• The great majority of Hemostasis tests performed in laboratories today are comprised of PT and APTT;

therefore, their efficient use is essential.

• HemosIL high-sensitivity, liquid, ready-to-use assays are available for PT, APTT, D-Dimer, Anti-Xa and more.

• These assays deliver efficiency by:

- Eliminating reconstitution errors for more accurate results

- Eliminating extra pipetting steps for increased efficiency

- Reducing labor utilization overall

Significant Reduction in Hands-on Tech Time for Vial Reconstitution*

HemosIL solutionCompetitor solution

* Data on file, IL.

** Assumes high-volume, routine testing with PT, APTT, D-Dimer and Fibrinogen assays.

Reduced by ~– 65%**

General Screening and Anticoagulant Monitoring/ Testing RecombiPlasTin® 2G PT-FIB HS Plus SynthASil

APTT-SP

Fibrinogen-C Q.F.A. Thrombin Liquid Anti-Xa Direct Thrombin Inhibitor*

Heparin-Induced Thrombocytopenia HIT-Ab(PF4-H)*

Thrombophilia Antithrombin

Protein C (Chromogenic) Protein C (Clotting) Free Protein S (Antigenic) Free Protein S (Clotting) FV Leiden (APC-R V) Homocysteine ThromboPath*

Antiphospholipid Syndrome Silica Clotting Time dRVVT Screen/Confirm

D-Dimer D-Dimer HS 500

D-Dimer HS D-Dimer 500* D-Dimer

Coagulation Factors Intrinsic Factors Extrinsic Factors FXIII Antigen von Willebrand Disease VWF:RCo*

VWF Activity VWF:Ag

FVIII

Fibrinolysis Plasminogen Plasmin Inhibitor

* Not FDA cleared. Not saleable in the U.S. I Liquid, ready-to-use format.

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A new breakthrough in Hemostasis testing ACL TOP Family 50 Series systems are the first in Hemostasis testing to automate and integrate:

• Pre-analytical sample integrity checks

• Advanced quality management

• Lab accreditation tools

ACL TOP Family 50 Series. Advanced automation and quality for lab efficiency and better patient care.

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The Instrumentation Laboratory logo, HemosIL, ACL, ACL AcuStar, ACL ELITE and ACL TOP are trademarks of Instrumentation Laboratory Company and/or one of its subsidiaries or parent companies and may be registered in the United States Patent and Trademark Office and in other jurisdictions. All other product names, company names, marks, logos and symbols are trademarks of their respective owners. ©2015 Instrumentation Laboratory. All rights reserved.

For more information, contact your local Werfen sales representative or distributor.

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Werfen Corporate Headquarters Plaza de Europa, 21–23 08908 L’Hospitalet de Llobregat Barcelona, Spain +34-93-4010101 werfen.com

Instrumentation Laboratory Headquarters 180 Hartwell Road Bedford, MA 01730 USA +1-781-861-0710 www.ilww.com

ACL TOP Family 50 Series standardizes the Hemostasis testing process—for flexibility, efficiency and enhanced patient care

Technical Specifications

Test menu Clotting, chromogenic and immunological assays

System configurations ACL TOP 750

ACL TOP 750 CTS

ACL TOP 750 LAS

ACL TOP 550 CTS

ACL TOP 350 CTS

Open-Tube Sampling Closed-Tube Sampling (cap-piercing) Laboratory Automation System compatibility (offboard sampling) Midsize with Closed-Tube Sampling Compact size with Closed-Tube Sampling

Samples onboard ACL TOP 750, 750 CTS

ACL TOP 750 LAS

ACL TOP 550 CTS

ACL TOP 350 CTS

Continuous from LAS track or 90 front-loaded

Pre-analytical sample checks

All ACL TOP Family 50 Series systems

Assay-specific HIL sample check and sample aspiration clog check

Reagents onboard ACL TOP 750, 750 CTS, 750 LAS

ACL TOP 550 CTS

ACL TOP 350 CTS

Patient samples results database

20,000 samples (configurable)

Throughput ACL TOP 750 PT . . . . . . . . . . . . . . . . . . . . . . . . . . . . up to 360 tests/hr (360 samples/hr) APTT . . . . . . . . . . . . . . . . . . . . . . up to 320 tests/hr (320 samples/hr) PT and APTT . . . . . . . . . up to 330 tests/hr (165 samples/hr)

ACL TOP 750 CTS PT . . . . . . . . . . . . . . . . . . . . . . . . . . . . up to 270 tests/hr (270 samples/hr) APTT . . . . . . . . . . . . . . . . . . . . . . up to 270 tests/hr (270 samples/hr) PT and APTT . . . . . . . . . up to 260 tests/hr (130 samples/hr)

ACL TOP 750 LAS Throughput from the LAS track is dependent upon factors such as LAS track configuration and settings

ACL TOP 550 CTS PT . . . . . . . . . . . . . . . . . . . . . . . . . . . . up to 240 tests/hr (240 samples/hr) APTT . . . . . . . . . . . . . . . . . . . . . . up to 180 tests/hr (180 samples/hr) PT and APTT . . . . . . . . . up to 180 tests/hr (90 samples/hr)

ACL TOP 350 CTS PT . . . . . . . . . . . . . . . . . . . . . . . . . . . . up to 110 tests/hr (110 samples/hr) APTT . . . . . . . . . . . . . . . . . . . . . . up to 110 tests/hr (110 samples/hr) PT and APTT . . . . . . . . . up to 110 tests/hr (55 samples/hr)

Unit dimensions (w x d x h)

ACL TOP 750, 750 CTS

ACL TOP 750 LAS

ACL TOP 550 CTS

ACL TOP 350 CTS

151 x 76 x 73 cm (59 x 30 x 29 in) 188 x 87 x 162 cm (74 x 34 x 64 in) (includes integrated table and arm) 110 x 82 x 73 cm (43 x 32 x 29 in) 81 x 84 x 73 cm (32 x 33 x 29 in)

Weight ACL TOP 750

ACL TOP 750 CTS

ACL TOP 750 LAS

ACL TOP 550 CTS

ACL TOP 350 CTS

162 kg (356 lbs) 166 kg (367 lbs) 184 kg (406 lbs) 147 kg (324 lbs) 91 kg (200 lbs)