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CORPORATE DESCRIPTION: 

First Medical is dedicated to providing better patient outcomes and more cost-effective health care through the creation of innovative and intelligent point-of-need diagnostics products, which are designed to improve workflow and to be used by medical personnel in a wide range of healthcare situations.

First Medical proudly shares Sigma Diagnostics’ commitment to the success of our customers through life science, technology and service.

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Hardware

Size: 17.5”L x 16.5”W x 9” H.  50 pounds
        (45cm x 42cm x 23cm / 22.7kg)

Data Transfer Capability: Yes

Specifications: 

Bar Code Reader

                    Format: Code 39, Code 128, UPC, EAN

                    Standards: Meets requirements of ASTM Standard E 1466-92

          Internal Printer

                    Thermal or self-adhesive, continuous roll

          Electrical

                    Power Requirements: 90-265 VAC (50/60 Hz)

                    Current Rating: 3A Max

          Environmental

                    Ambient Temperature: 18° to 32° C (64° to 90° F)

                    Humidity: 95% noncondensing

                    Placement: minimum of 4” (10 cm) from wall, on level tabletop

          or cart in a relatively dust-free area.

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Features

• Complete quantitative cardiac marker profiles for Myo, CK, CK-MB, TnI in < 18 minutes

• 24-hour availability 7 days a week

• Bi-level controls with every sample

• Factory calibrated

• Biohazard safety: closed-tube whole blood sampling

• Bar code sample identification

• LIS data transmission

• On-board patient results storage and presentation with reference to clinical parameters

Test Menu: (Analytes that can be performed on instrument)

• Creatine Kinase  (CK)
• CK-MB
• Troponin I (TnI)
• Myoglobin (Myo)

CPT codes:  (For each analyte)

Analyte	CPT Code
Creatine Kinase (CK)	82550
CK-MB	82553
Myoglobin (Myo)	83874
Troponin (TnI), Quantitative	84484

Test Methodology: Sandwich fluorescent immunoassay.

Units in which test result is reported: µg/mL  or  ng/mL

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Software

Patient Profile Graph	Internal QC Levey Jennings chart	Patient Identification Parameters
Scan Sample ID	Operator List	Back to top

Software information requirements

Name of software package:                N/A (Integrated with the Alpha Dx POINT-OF-NEED System)

Current version # availability:             N/A

Included download capability:             N/A

Operating download capability:         N/A

Administration features

The software is configurable, allowing Administrators to:

• Track and visualize Internal and External QC results in a graph or table format

• Establish access codes for Operators/Users

• Track Operator (User) Training Dates and Certification

• Determine Patient Information inputs required for sample processing

• Input hospital defined Clinical Cutoff and Reference Limit values

• Set Date format

• Set Bar Code Reader options for Patient ID or Operator ID

• Set internal printer to on or off

• View/print patient data in a graph or table format

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User features:

• Easy-to-use: 30-second walk-away operation

• Factory calibrated: always ready for use

• Biohazard safety: closed tube, whole blood sampling format

• Compact size: fits into a wide range of clinical settings

• Assay confidence: bi-level quality controls run with every patient sample

QC features: The Alpha Dx POINT-OF-NEED System is specifically designed to deliver assay confidence by providing on-board quality control (QC) measures for all the critical stages of the testing process: pre-analytical, analytical & post-analytical.

Pre-Analytical QC:

• Operator ID and Verification Checks

• Sample ID Tracking

• Tracking Consumables Integrity and Usage

• No Sample Preparation

Analytical QC:

• Chemistry QC: Bi-level controls are run with every sample.  If controls fall outside established ranges, the results for that marker are automatically suppressed.

• Internal Electronic QC

• Optical QC

• Data Processing QC

Post-Analytical QC

• Verification of Results against internal bi-level QC results.

• Data Interpretation: Clinically relevant results are ‘flagged’

• Data Transmission: Ethernet and RS232 options

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Instrument Management features

The Alpha Dx POINT-OF-NEED Analyzer requires no preventive maintenance. The only additional operator interactions required are entering new Test Disc lot information using a Calibration Diskette, changing the printer paper, or inserting a new Fluid Cassette.

Inventory Control Feature

Test Discs and Fluid Cassettes are labeled with a bar code to monitor lot and expiration date information. The Analyzer automatically verifies that the calibration parameters (loaded via the Calibration Diskette) are present for a Test Disc lot and the expiration date is valid before proceeding with a test.

Reporting features

Administrators may obtain reports on:

• Patient Profile – test results

• Quality Control, both Internal and External QC

• Calibrated Lots information

• Operator Information

• Training Status Log for Operators and Administrators 

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Install base:   N/A

Export capability: Yes

LIS interface capability? Yes, Ethernet and RS232.

Y2K Compliant with contact information for verification and more information. 

Yes.  Contact techsupport@firstmedical.com

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Last updated:  09/15/2003
Questions or corrections:  Webmaster
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