_{Nanoduct Neonatal
Sweat Analyzer}

_{Nanoduct is a complete, integrated system for inducing and analyzing sweat for cystic fibrosis (CF) diagnosis that produces a result while attached to the patient. Nanoduct simplifies the CF sweat test and for the first time makes possible reliable CF diagnosis in the first days of life. To accomplish this, Wescor has combined and miniaturized the proven technology of its Macroduct and Sweat-Chek systems to accommodate the tiny limbs of newborn infants-only Nanoduct can routinely produce a reliable confirmation or denial of CF diagnosis as soon as a newborn's sweat glands are capable of producing sweat.}

_{Physical size is not the only Nanoduct advantage: its continuous flow sensor requires only a miniscule specimen and monitors real time sweat electrolyte concentration with unprecedented resolution. And Nanoduct can be safely used on patients of any size or age.}

_{It is well known that early diagnosis and treatment of cystic fibrosis can significantly improve the quality of life and lifespan of children who suffer from CF. Nanoduct gives you the tools for early intervention against this dreaded disease.}

_{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 Induction/Analysis Module. This is followed by continuous-flow analysis of sweat electrolyte concentration using the unique conductivity sensor. Electrodes and the sensor are connected to the Induction/Analysis Module.}

• _{Shorter Stimulation Time}

  _{Pilogel Ionotpheretic discs have been improved to allow maximum gland stimulation after 2.5 minutes of iontophoresis at 0.5 mA total current, which is desirable both for safety and time of involvement for neonates. arbitrary assignment of minimum sweat yield. As soon as sweat enters the microconductivity cell, the display alerts the operator to the presence of sweat. After a very short interval, the display reads out the initial sweating rate and gives continuous reading of real-time conductivity.}

• _{Requires Only 3 Microliters of Sweat}

  _{The miniscule dimensions of the conductivity sensor allow a reading to be obtained at a minimum production of only 3 microliters of sweat, which, for reasonably mature glands usually happens within 6 minutes after applying the sensor.}

• _{Continuous Flow Analysis of Electrolyte Content}

  _{When the sensor is attached to the patient, the stimulated sweat emerging form the sweat glands is anaerobically directed by the conical collecting surface into a microconductivity cell within the sensor. This provides a continuous display of the electrical conductivity in the freshly emerged sweat. Conductivity has been shown to be the equal of chloride in its ability to discriminate diagnostically between CF and non-CF subjects.}

• _{Separate Collection Phase is Eliminated}

  _{Continuous -flow analysis, while the sensor is on the limb, combines the separate collection and analytical phases and thus ends the need to handle or transport the sweat specimen. This method ensures that the conductivity result is constantly updated to represent the freshly excreted sweat arriving at the measuring cell. This has the advantage of eliminating potential handling errors, saves laboratory time and assures accuracy by providing virtually infinite replications of the analysis on freshly excreted sweat. A further benefit is that any inadvertent contamination of the sensor collecting surface will be dissipated before the final reading is displayed.}

• _{Automatic Averaging of Conductivity}

  _{For the first minute or two after stimulation, the sweat electrolyte concentration drops rapidly, then slows to a steady slow decrease. To standardize the result with commonly used reference ranges, the instrument automatically waits 3 minutes after the first display of conductivity, then commences a 5 minute averaging sequence, and then displays the resulting average value as the reportable diagnostic result.}

• _{Neonate-to-Adult Capability}

  _{While Nanoduct is designed for neonates, it works equally well on patients of any age.}

• 

  _{NANODUCT
  Patient Simulator}

  _{Neonatal Sweat
  Analysis System}

  _{The Patient Simulator is a bench top accessory to the Nanoduct system that allows a liquid electrolyte solution to be introduced into a standard Nanoduct sensor. The solution is then warmed in the sensor and held at the temperature of a normal human during Nanoduct sweat testing.}

  _{The Patient Simulator allows laboratories to run liquid sweat sample for proficiency testing or comparative evaluation of liquid samples with Nanoduct and other instruments. Laboratories with CAP survey accreditation requirements can now use the Nanoduct Patient Simulator to assay simulated liquid sweat through the Nanoduct sweat testing system to meet CAP certifications.}

• Specifications for the Nanoduct Neonatal Sweat Analysis System
  Sweat Induction Control	Current profiled for patient comfort. For use with Pilogel Ionotpheretic discs and with fail-safe features to limit current in failure mode. Nominal current is 0.3 mA fro 2.5 minutes.
  Current Limit (Failure Mode)	Maximum failure mode current limited to 5 mA with fresh battery
  Sweat Analysis	Sweat Conductivity with readout expressed as mmol/L (equivalent NaCl).
  Range	0 to 200 mmol/L (equivalent NaCl).
  Instrument Linear Error	1% or less from 75 to 110 mmol/L (equivalent NaCl).
  Initial Sweating Rate Reading	0.1 to 10 g/m2/min.
  Calibration	Single point automatic calibration at 80 mmol/L (equivalent NaCl).
  Power Supply	One 9.0 volt lithium battery (alkaline battery can be used). 100 milliwatt power use during operation. Lithium batteries are good for approximately 300 tests.
  Readout	128 x 64 dot graphic display with multi-lingual support.
  Audio Signals	ALERT and ALARM audible signals.
  Keyboard	ON, OFF, SELECT and ENTER keys.
  Connection	5 pin connector to mate with induction/conductivity cell cable.
  Operating Temperature	13 to 30 ºC.
  Storage Temperature	0 to 60 ºC.
  Regulatory	Meets EN 61326 standards for EMC compatability. Meets IEC 60601 standards for safety. Manufactured under Wescor’s quality system (ISO 9001).
  Physical	Housed in portable carrying case with a storage compartment for supplies and handle for ease of carrying.
  Dimensions (H x W x D)	16 cm x 23 cm x 33 cm.
  Weight	Less than 2.25 kg.
  Buyer’s Specifications The neonatal analyzer shall be a Wescor Nanoduct® Neonatal Sweat Analysis System and shall use pilocarpine iontophoresis for sweat induction and employ continuous flow analysis of sweat conductivity to produce a diagnostic result.
  Specifications for the Nanoduct Patient Simulator (Catalog # AC-111)
  Power	7.5 to 14 Volts. Currents less than .4 Amps during peak heating. Jack for external power supply: 12 V AC/DC adapter provided. Internal connections for two standard 9 Volt batteries (NEDA/ANSI 1604A). Auto shut off after 10 minutes. Can be extended by pressing RESTART button.
  Temperature	Holds liquid sample at 31.5°C ±1°C.
  Keyboard	ON, OFF switch and RESTART button.
  Regulatory	Meets EN 61326 Standards for EMC compatibility. Meets IEC 60601 standards for safety. Manufactured under Wescor’s quality system (ISO 13485). Bears the CE mark as a Class IIa medical device. Certificate issued by BSI 0086.
  Size	Approximately 11.43 cm x 10.92 cm x 11.43 cm (W x D x H) (4.5” x 4.3” x 4.5”).
  Weight	Approximately 0.7 kg (1.5 lbs.).