PFA-100 System

The PFA-100® System measures the complex process of primary hemostasis and aids in the rapid detection of platelet dysfunction. It is the first commercially available in vitro testing system to incorporate high-shear flow in which the process of platelet adhesion and aggregation following a vascular injury is simulated in-vitro.

The PFA-100 System provides automated assessment for inherited, acquired, or drug-induced platelet dysfunction.

  • Helps detect inherited, acquired and drug-induced platelet dysfunction
  • Screening test for patients with impaired primary hemostasis, such as von Willebrand disease1
  • Verifies efficacy of desmopressin acetate (DDAVP) therapy in pre-surgical patients2
  • Assesses the platelet dysfunction due to the effect of Aspirin
  • Evaluates platelet dysfunction in children over 1 year of age3
  • Evaluates platelet dysfunction in multiple clinical settings, such as presurgical screening, high-risk pregnancy and menorrhagia

Features & Benefits

The PFA-100 System has become the new standard for detection of platelet dysfunction. The PFA-100 Analyzer quickly and easily measures platelet plug formation in a small, whole blood sample (<1 mL) and reports a ”Closure Time” in 5-8 minutes. It is a unique system that challenges platelets under high shear flow conditions similar to the physiologic environment in which platelets normally function. It detects inherited-, acquired- or induced- platelet dysfunction by uniquely simulating, in vitro, the function of platelets in Primary Hemostasis

A Model of Efficiency:

  • Accurate detection of inherited, acquired or induced platelet dysfunction under high-shear stress
  • Sensitive to quantitative and qualitative abnormalities of VWD in both plasma and platelets
  • Simple, rapid and precise assessment of platelet function

Test Menu:

  • Collagen/Epinephrine and Collagen/ADP test cartridges

Features:

  • Easy to use - self-contained disposable test cartridges
  • Fast - delivers quantitative results within 5 to 8 minutes
  • Cost savings - minimal sample manipulation and maintenance required

Technical Specifications

Test System

Principle

High-shear force dynamic flow system

 

Measuring channel

Single measuring channel

 

Incubation category

Two incubation wells

 

Incubation temperature

37.9 °C ± 1.0 °C

 

Incubation warm up-time

<15 minutes (room to operating temperature)

 

 

 

 

Sample Handling

Type of sample

Citrated whole blood

 

Sample mechanism

Manual pipette dispensing (800 μL)

 

Barcode identification

Optional external barcode reader for sample identification

 

 

 

 

Reagent Handling

Type

Single disposable self-contained test cartridge

 

Reagent recognition

Positive optical coding reagent cartridge identification

 

Additional reagent

Trigger solution

 

 

 

 

Throughput

Single test

Col/EPI or Col/ADP: 6 tests/hour

 

Duplicate test

Col/EPI or Col/ADP: 10 tests/hour

 

 

 

 

Software

Interface

LCD display

 

Host connection

Unidirectional, external PC RS-232 25 pin D port

 

Patient ID

Maximum 12 numeric characters

 

Stored control results

Last 50 results

 

Stored patient results

Last 20 results

 

Software update

PCMCIA Card

 

 

 

 

Printer

Printer

Built-in dot matrix printer, sound level printing 77 dBA

 

Type

Ribbon Epson #ERC-22 black or #ERC-09 purple

 

Printer paper

58 mm wide paper roll

 

 

 

 

Power Supply

Operating voltage

100 – 130 V / 60 Hz, 200 – 250 V / 50 Hz

 

Mains frequency

50 – 60 Hz

 

Current (maximum)

1.5 A @ 100 V, 0.75 A @ 200 V

 

Power consumption

110 W (maximum)

 

Fuse

Sloblo, 250 V, 1.5 A

 

Note

Main supply voltage should not exceed recommended ranges

 

 

 

 

Environmental Conditions

Operating temperature

 18 - 29 °C

 

Non-operating storage

 -29 - 50 °C

 

Relative humidity

 20 - 90 %

 

Altitude (maximum)

 2000 meters

 

Operating humidity

 20 - 90 % RH

 

Non-operating storage humidity

 0 - 95 % RH

 

Heat emission

 94 kcal/h (375 BTU/h)

 

 

 

 

Dimensions

Dimensions

384 mm x 229 mm x 360 mm (W x D x H)

 

Weight

10.9 kg

 

 

 

 

Remarks

The PFA-100 System is available for sale in the US and complies to the IVD Directive 98/79/EC.

Catalog No.

Product Description

Quantity

B4170-00

PFA-100 Analyzer

1 unit

B4170-20

Dade® PFA-100 Collagen/EPI Test Cartridges

1 x 20 pieces

B4170-21

Dade PFA-100 Collagen/ADP Test Cartridges

1 x 20 pieces

B4170-50

Dade PFA-100 Trigger Solution

3 x 11 mL

Assays

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