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Medtronic Inc.

Medtronic Perfusion Systems, USA
7611 Northland Drive
Brooklyn Park, MN 55428
United States
Phone: (763) 391-9000
Toll-Free: (800) 328-3320

www.perfusion.medtronic.com

CORPORATE DESCRIPTION:

Medtronic Perfusion Systems is a division of Medtronic CardioVascular and is comprised of over 3,000 committed and passionate employees worldwide who are dedicated to serving medical practitioners with perfusion and blood management solutions. We are constantly fulfilling our mission to alleviate pain, restore health and extend lives. Our products include the ACT Plus® System and the HMS Plus Hemostasis Management System.

PRODUCT DESCRIPTIONS:

ACT Plus® System (website)

The ACT Plus® System combines a trusted standard in precise clot detection technology with state-of-the-art user features including data management and connectivity-ready capabilities. It is a microprocessor-controlled electromechanical coagulation instrument designed to determine coagulation endpoints in fresh and citrated whole blood samples. Clotting-time results are presented on the instrument’s Clot Time Display (CTD) and Liquid Crystal Display (LCD) screens.

Instrument Specifications:

CLIA Classification

Moderately complex

Size and weight:

11.98 (h) x 9.0 (w) x 13.6 (d); 11.5 lb (w)

Power:

Voltage – 100-240 V ~ Single phase

Frequency: 

50 – 60 Hz

Maximum Current: 

1.0 A (100-240)

Operating Limits - Temperature: 

14° C to 32° C (57° F to 90° F)

Humidity: 

10% to 90%, noncondensing

Data transfer capability:

Serial Data Port:  19200 baud, 8 data bits, 1 stop bit, no parity
USB:  2.0

Test Menu:

High Range ACT, Low Range ACT, Recalcified ACT, and High Range Heparinase ACT

Features:

Duplicate channel testing, real-time clot detection, stores up to 1000 patient/QC records, stores up to 600 operator IDs, QC and User Lockout, optional barcode scanner, optional data management program.

CPT code: 

85347

Test Methodology:

Liquid-suspended, Kaolin activator, Electromechanical clot detection

Sample volume: 

 High Range ACT and High Range Heparinase - 800 mcl; Low Range and Recalcified ACT – 400 mcl

Included Accessories

 AC power cord, USB cable

Software Specifications:

Name of software package:

ACT Plus EDM, external data manager

Current version # availability: 

Version 1.06

Operating system capability:

MS Windows XP or higher

Administration features: 

Device operator management including certification

QC features:

QC and patient reports, including audit and Levy Jennings

Instrument Management features: 

Service and maintenance reports

Reporting features:

Preformatted reports and Microsoft Access Database

LIS Interface capability:

Via Connectivity Vendor:  RALS Plus, TELCOR, Aegis POC

HMS Plus Hemostasis Management System (website)

The HMS Plus Hemostasis Management System is a reliable and versatile platform used to perform multiple tests for heparin management. By providing information regarding the individual patient's response to heparin, the HMS Plus System determines the appropriate dose for the patient so that the needed anticoagulant and antithrombotic effect can be achieved.

Instrument Specifications:

CLIA Classification

Moderately complex

Size and weight:

15.75 (h) x 13.0 (w) x 15.0 (d); 34.1 lb (wt)

Power:

Voltage – 100-240 V ~ Single phase

Frequency: 

50 – 60 Hz

Maximum Current: 

1.2/0.6 A (100-120/200-240)

Operating Limits - Temperature: 

14° C to 32° C (57° F to 90° F)

Humidity: 

10% to 90%, noncondensing

Data transfer capability:

Serial Data Port:  19200 baud, 8 data bits, 1 stop bit, no parity

Test Menu:

Heparin Dose Response, Heparin Assay, and High Range ACT

Features:

Determines patients individual response to heparin, Measures actual circulating heparin concentration, performs a duplicate channel ACT test, QC and User Lockout, optional barcode scanner, optional data management program.

CPT code: 

Heparin Assay - 85520, ACT - 85347

Test Methodology:

Heparin Dose Response and HR-ACT  Liquid-suspended, Kaolin activator, Electromechanical clot detection.  Heparin Assay:  Heparin Protamine Titration

Sample volume: 

Heparin Dose Response-3.0 mL; Heparin Assay with High Range ACT-2.5mL

Software Specifications:

Name of software package:

HMS Plus EDM, external data manager

Current version # availability: 

Version 1.1.2

Operating system capability:

MS Windows 2000 or higher

Administration features: 

Device operator management including certification

QC features:

QC and patient reports, including audit and Levy Jennings

Instrument Management features: 

Service and maintenance reports

Reporting features:

Preformatted reports and Microsoft Access Database

LIS Interface capability:

Via Connectivity Vendor:  RALS Plus, TELCOR, Aegis POC

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