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Nanoduct® Neonatal Sweat Analysis System


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Nanoduct® Neonatal Sweat Analysis System

The Nanoduct Neonatal Sweat Analysis System simplifies the sweat test and for the first time makes possible reliable laboratory diagnosis of cystic fibrosis in the first days of life.

Description

Early diagnosis and treatment can significantly improve both the quality of life and the lifespan of children born with cystic fibrosis. The proven diagnostic effectiveness of analyzing electrolyte concentration in sweat makes it vital to perform this test as soon as possible after birth.

ELITech-Wescor has long been the leading innovator in the laboratory diagnosis of cystic fibrosis with the Macroduct Sweat Collection System, along with chloride ion assay or analysis with the Sweat-Chek™ Sweat Conductivity Analyzer.

GROUND BREAKING INNOVATION BASED ON PROVEN TECHNOLOGY

The Nanoduct Neonatal Sweat Analysis System combines and miniaturizes the proven collection and analysis technologies of Macroduct and Sweat-Chek to accommodate the tiny limbs of newborn infants, and provides reliable laboratory diagnosis of CF as soon as a newborn’s sweat glands are capable of producing sweat.

Innovative features of the Nanoduct System include the special electrode/sensor holders that are positioned on the patient’s limb before iontophoresis. The holders make electrode placement simple and secure. They also guarantee that the sensor’s collecting surface is perfectly registered with the stimulated skin area and attachment pressure is optimal when the sensor is attached.

Nanoduct incorporates the classic method of inducing sweat by pilocarpine iontophoresis. The pilocarpine is carried into the dermis of the patient from improved Pilogel® Iontophoretic Discs by a controlled DC electric current supplied by the Nanoduct System.

This is followed by continuous flow analysis of sweat electrolyte concentration using the unique conductivity sensor. Electrodes and the sensor are connected to the Nanoduct System via a single control cable.

The Nanoduct Neonatal Sweat Analysis System simplifies the sweat test and for the first time makes possible reliable laboratory diagnosis of CF in the first days of life.

CONTINUOUS-FLOW ANALYSIS OF ELECTROLYTE CONTENT

When the sensor is attached to the patient, the stimulated sweat emerging from the sweat glands is anaerobically directed into a microconductivity cell within the sensor. This provides a continuous display of the total electrolyte content and initial sweating rate in the freshly emerged sweat. Total electrolyte concentration has been shown to be the equal of chloride in its ability to discriminate diagnostically between CF and non-CF subjects.

SEPARATE COLLECTION PHASE ELIMINATED

Continuous-flow analysis while the sensor is on the limb, eliminates potential handling errors, saves laboratory time, and ensures accuracy by providing virtually infinite replications of the analysis on freshly excreted sweat. A further benefit: any inadvertent contamination of the sensor collecting surface will be dissipated before the final reading is displayed.

IMPROVED PILOGEL® DISCS

  • Increased pilocarpine concentration
  • Iontophoresis time reduced to only 2.5 minutes
  • Buffered to prevent pH changes

Readout

  • 128 x 64 LCD graphic display (non-backlit). Supports up to 8 lines of 18 characters or numerals, with multi-lingual support (English, French, German, and Spanish).

Sound

  • Alert and Alarm signals.

Keyboard
ON, OFF, SELECT and ENTER keys.
Electrode Connection

  • 6 pin locking medical connector to mate with induction/conductivity cell, cable.

Serial Outputs
RS-232 (ASCII format)
9-pin D-Sub male connector.
Data Protocol: 9600 Baud, 1 Start Bit, 8 Data Bits, No Parity, 1 Stop Bit.

  • Pin #1
    Signal: N/C
    Description: No Connection
  • Pin #2
    Signal: RXD
    Description: Receive Data (output)
  • Pin #3
    Signal: TXD
    Description: Transmit Data (input)
  • Pin #4
    Signal: N/C
    Description: No Connection
  • Pin #5
    Signal: GND
    Description: Signal Ground
  • Pin #6
    Signal: N/C
    Description: No Connection
  • Pin #7
    Signal: N/C
    Description: No Connection
  • Pin #8
    Signal: CTS
    Description: No Connection
  • Pin #9
    Signal: N/C
    Description: No Connection

USB – Device
Type B Receptacle.
Electrical

  • Four AA Alkaline batteries (NEDA 15A, IEC LR6).
  • Typical solid-state, over-current circuit protection.
  • 3.0 VDC lithium coin cell for the real time clock. Extended battery life of lithium cell is 75 years.

Sweat Induction Control

  • Current profile controlled for use with Pilogel Iontophoretic disks with multiple fail-safe circuits to limit current. Nominal current is 0.5 (± 0.02) mA for 2.5 minutes (± 0.2 Sec.) Maximum fail-safe current limited to 5 mA.

Sweat Induction Control

  • Current profile controlled for use with Pilogel Iontophoretic disks with multiple fail-safe circuits to limit current. Nominal current is 0.5 (± 0.02) mA for 2.5 minutes (± 0.2 Sec.) Maximum fail-safe current limited to 5 mA.

Real Time Clock

  • ± 2 minutes per year (battery backed).

Operating Temperature

  • 15 to 30 °C (59 to 86 °F).

Storage Temperature

  • 0 to 60 °C (32 to 140 °F).

Dimensions (H x W x D)

  • 7.5 x 5 x 2 in (19.1 x 12.7 x 5.1 cm).

Weight

  • 1.2 lb (0.5 kg).

Carrying Case (weight with instrument)

  • 13.5 x 10.5 x 4 in (34.3 x 26.7 x 10.2 cm)
  • 4.0 lb (1.8 kg).

Conductivity Readout

  • mmol/L (equivalent NaCl).

Conductivity Range

  • 3 to 200 mmol/L. *

Error

  • 1% or less from 25 to 150 mmol/L (equivalent NaCl).

Initial Sweat Rate

  • 0 to 50 g/m2/min.

Calibration

  • Single point automatic calibration at 80 mmol/L (equivalent NaCl) using the AC-081 Calibration Plate.

* Solutions with a conductivity of less than 3 mmol/L are reported on the instrument as ≤ 3 mmol/L (equivalent NaCl).

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