Elitech NANODUCT 1030 User manual

NANODUCT®
USER’S
MANUAL
MODEL 1030
Neonatal Sweat Analysis System

NANODUCT®
NEONATAL SWEAT ANALYSIS SYSTEM
MODEL 1030
USER’S MANUAL
57-0008-02A
(Last update 7/8/2020)

© 2020 ELITechGroup Inc. All rights reserved.
Printed in the United States of America. No part of this publication may be reproduced, transmitted, transcribed,
stored in a retrieval system, or translated into any language (human or computer) in any form, or by any means
whatsoever, without the prior express written permission of ELITechGroup Inc.
Webster Sweat Inducer™, and Sweat-Chek™, are trademarks of ELITechGroup Inc. Wescor®, Pilogel®and
Macroduct®are registered trademarks.
Other trade names used in this manual are trademarks of their respective owners, used here for information
only.
ELITechGroup Inc. makes no express or implied warranty regarding this manual, its quality, performance, or
appropriate use regarding any type of specic procedure. ELITechGroup Inc. may modify this manual without
notice and without implying any obligation or liability on the part of the company.
Manufactured in the United States of America by:
ELITechGroup Inc.
370 West 1700 South
Logan, Utah 84321-8212 USA
2797
The Notied Body number above signies that British Standards Institute BSI has certied the Production
Quality Assurance System of ELITechGroup Inc., according to Annex V of the Medical Device Directive 93/42/
EEC (MDD). The scope of that certicate, CE 59518, is:
The manufacture of sweat analysis systems for cystic brosis; and sweat inducers (to obtain samples for use in
the subsequent laboratory diagnosis of cystic brosis).
This covers the Class IIa devices Macroduct Advanced Model 3710, Macroduct Model 3700, and Nanoduct
Model 1030. Together with the Declaration of Conformity issued by the manufacturer according to Annex VII,
this allows the CE marking of these devices. There are no accessories to which the CE certicate or the BSI
Notied Body Number 2797 applies.

Table of Contents
Section 1: Introduction
1.1 Overview 7
1.2 Customer Service 13
1.3 System Description 14
Holders 14
Iontophoretic Electrodes 14
Electrode Cable Assembly 14
Pilogel Iontophoretic Discs 15
Sensor Cell 15
Induction/Analysis Module 16
1.4 Controls and Connections 17
Display 17
Serial Data Ports 18
Section 2: Initial System Setup
2.1 Installing or Replacing the Batteries 21
2.2 Menu Basics 22
Startup Menu 22
Accessing the Setup Menu 22
Using the Congure Menu 23
Setting the Time and Date 23
Setting Options 25
Setting Language 26
Self Test Mode 26
Demo Mode 28
Section 3: Sweat Induction and Analysis
3.1 Performing the Sweat Test 30
3.2 Interpreting the Sweat Test 37
Units of Conductivity 37
Automatic Averaging 37
Diagnostic Ranges 38
Initial Sweat Rate 38
Notes Regarding Sweat Rate 39
Section 4: Troubleshooting and Preventive Maintenance
4.1 Troubleshooting 40
General Troubleshooting and Diagnosis 40
Error Message Troubleshooting and Diagnosis 43
4.2 Cleaning the Instrument 49
4.3 Calibration and Checking Control Values 50
Patient Simulator 50
Calibration Plate 50
Instructions 50
Appendix A: Instrument Specications 52
Appendix B: Accessories, Supplies, and Replacement Parts 54
Appendix C: Serial Data Ports 55
USB Port 55
Appendix D: Critical Components 56
Appendix E: Pilogel Information 57
Appendix F: Storage and Handling Conditions 59
Storing the Instrument 59
Appendix G: Shipping and/or Disposal Instructions 60
Shipping the Nanoduct 60
Disposal of the Instrument 60

Appendix H: Supplemental Information 61
Cystic Fibrosis: A Brief Description of the Disease 61
The Evolution of Sweat Test Methods 61
Development of the Nanoduct Neonatal Sweat Collection System 63
References 64
Appendix I: Pilocarpine Iontophoresis: Requirements and Risks 65
Burns Under Iontophoresis 65
Appendix J: Electromagnetic Compatibility (EMC) 66
Index 69

7
1.1 Overview
This manual describes the complete procedure for the laboratory diagnosis of cystic brosis, particularly
in the early neonatal period, through examination of sweat electrolyte concentration using measurement
of electrical conductivity. The rst section gives a brief description of the system, its components, and
how to set up the system. The second section describes the procedure for stimulating and analyzing
sweat. The third section gives needed information on the analysis of sweat. In addition, instructions for
troubleshooting and maintenance of the system are provided in the fourth section. A detailed description
of the development of the Nanoduct System is presented later in the manual, along with additional useful
information.
Intended Use
The Nanoduct Neonatal Sweat Analysis System is intended for laboratory use by qualied personnel to
provide laboratory diagnosis of cystic brosis.
Application
Anyone operating a Nanoduct Neonatal Sweat Analysis System must be thoroughly familiar with the
procedures and cautionary information detailed in this manual before attempting a sweat test. Abbreviated
instructions printed elsewhere are provided for reference only. Do not use them as a substitute for the
complete information contained in this manual.
The Pilogel Discs for Nanoduct are designed to be used with this instrument and should be used wherever
they are legally available. In areas where they are not available, users should check with ELITechGroup
for the availability of ber pilocarpine reservoirs of the same size as Pilogel discs, for use with pilocarpine
solutions supplied by the user. Unless otherwise indicated, any mention of Pilogel discs in this manual
applies equally to the ber pilocarpine discs.
Safety Regulations (Nanoduct Model 1030)
Classication
This equipment is classied as Type BF Medical Equipment, Internally Powered.
This device has been built and tested in accordance with safety regulations under EN 60601-1. In order
to maintain this condition and ensure safe operation, the operator must observe all the instructions and
warnings contained in this manual. For current information about applicable standards, please refer to the
CE Declaration of Conformity included with the documents shipped with this device.
NOTE: This equipment complies with the following emission and immunity requirements: IEC/EN 60601-1-
2 and FCC CFR 47 Part 15 Class B/ICES-003 Class B (using IEC CISPR 22 / EN55022).
Specication of Safe Use
Using this equipment in a manner not specied by ELITechGroup may impair safety protection and may
lead to injury. Do not use where ammable anesthetic is present or in any oxygen-enriched environment.
Do not connect the serial port or USB port to external sources while the Nanoduct is connected to a
patient.
WARNING!
Do not use this equipment if it is not functioning properly.
Section 1: Introduction

88
Section 1: Introduction
Statement of Environmental Limits
This equipment is designed to be safely operated at 15 to 30 °C, with maximum relative humidity less than
85%, and atmospheric pressure ≥ 79.5 kPa.
Understanding Warnings
This manual uses three warning levels to alert the operator to important information as shown in the
following examples.
WARNING!
A Warning alerts to the possibility of personal injury, death, or other serious adverse reactions
stemming from the use or misuse of this device or its components.
CAUTION:
A Caution alerts to possible problems with the device associated with its use or misuse. Such
problems include device malfunction, failure, damage, damage to the sample, or damage to other
property. Where applicable, a Caution may include precautions to be taken to avoid the hazard.
NOTE: A Note reinforces or supplies additional information about a topic.
Specic Warnings
Pay particular attention to the following safety precautions. If these safety precautions are ignored,
personal injury or damage to the device may occur. Each individual precaution is important.
WARNING!
Due to the possibility of an explosion, never attempt iontophoresis on a patient receiving
oxygen-enriched respiratory therapy in an enclosed space, such as an oxygen tent (nasal
cannula is acceptable). With medical approval, remove the patient from that environment during
iontophoresis.
WARNING!
Do not stimulate or collect sweat from the following sites:
• Head, including forehead (possible burns).
• Trunk (current crossing heart).
• Any area of inammation (e.g. eczema or rash); serous or bloody discharge (contamination).
WARNING!
Do not use over areas with metal plates/pins.
WARNING!
Never attempt to reuse single use components/accessories.
WARNING!
Do not use electrodes or Pilogel discs that have been altered or appear damaged.
WARNING!
Consult a physician before performing a test on patients with clinically diagnosed cancer.

99
Section 1: Introduction
WARNING!
Consult a physician before performing a test on patients who have had previous adverse reactions
to electrotherapy.
WARNING!
The lithium coin cell backup battery used to power the clock is not accessible to the user and
should only be replaced by qualied service personnel.
CAUTION:
A Nanoduct sweat analysis test should be carried out at a time when the patient is clinically stable,
well-hydrated, free of acute illness, and not receiving mineralocorticoids.
CAUTION:
Consult a physician before performing multiple tests on a patient within a 24-hour period.
CAUTION:
Pilogel discs should be refrigerated at 2 °C to 10 °C. DO NOT FREEZE. Never use discs that have
been frozen or that are cracked.
CAUTION:
This equipment has been designed and tested to EN 55011/CISPR 11 Group 1 Class B and FCC CFR
47 Part 15 Class B. In a domestic environment it may cause radio interference, in which case, the
operator may need to take measures to mitigate the interference.
CAUTION:
Only spare parts and accessories supplied or specied by ELITechGroup should be used with this
device. Using non-approved parts may a󰀨ect the performance and safety features of the device.
If the device is used in a manner not specied by ELITechGroup, the protection provided by the
device may be impaired. If in doubt, contact an ELITechGroup representative.
CAUTION:
The USB connection on the device is intended to be used by authorized personnel. For security
purposes, it is recommended to execute a virus/malware scan on any computers prior to making
connection. Do not connect to a line powered computer when the instrument is attached to a
patient.

1010
Section 1: Introduction
Contraindications
• Patients with an implanted device, such as a debrillator, neurostimulator, pacemaker, or ECG monitor.
• Patients with a history of epilepsy or seizures.
• Patients who are pregnant.
• Patients that have a known sensitivity or allergy to any ingredient.
• Over damaged, denuded skin or other recent scar tissue.
• Patients with cardiac conditions or with suspected heart problems.

1111
Section 1: Introduction
EXPLANATION OF SYMBOLS
SYMBOL EXPLANATION
Classication of degree of protection against electric
shock (BF)
Authorized Representative in the European Community
Batch Code
Biological Hazards (Biological Risks)
Catalog Number (Model Number)
Serial Number
Consult Instructions For Use
General Warning, Caution, Risk of Danger
Caution, Consult Accompanying Documents (Attention,
see instructions for use)
CE Mark, product meets the essential requirements
designated in Annex V of the Medical Device Directive
93/42/EC (MDD).
Do Not Reuse
Do not use if package is damaged
Manufacturer
General Symbol for Recovery, Recyclable
Waste of Electrical and Electronic Equipment (WEEE)
Symbol. Under Directive 2012/19/EU, this equipment
cannot be disposed of in a normal landll.
Environment Friendly Use Period

1212
Section 1: Introduction
SYMBOL EXPLANATION
Use By
Temperature Limitation – indicates high and low limits
Warning, Biological Hazard
Harmful / Irritant
Environment Hazard
Toxic

1313
Section 1: Introduction
1.2 Customer Service
ELITechGroup is dedicated to assisting in every aspect of sweat testing theory and practice. ELITechGroup
is the acknowledged world leader in the development of innovative systems for cystic brosis diagnosis by
sweat testing.
This manual contains basic maintenance, troubleshooting, and service information. ELITechGroup is
prepared to help you resolve any di󰀩culty with the operation or performance of your Nanoduct Neonatal
Sweat Analysis System. If a problem cannot be solved using the procedures described in this manual,
please contact ELITechGroup’s Service Department to help resolve any questions about the operation or
performance of your Nanoduct system.
Customers should contact ELITechGroup by telephone, fax, or e-mail. Outside the U.S., many of our
authorized dealers o󰀨er customer service and support.
ELITechGroup Inc.
370 West 1700 South
Logan, Utah 84321-8212 USA
Telephone:
800 453 2725 (United States & Canada)
([phone] (International calls)
Fax:
435 752 4127 (US)
([phone] (International)
Email:
[email protected] (Service)
[email protected] (Sales)
Web Page:
www.elitechgroup.com (EU)
European Authorized Representative:
MT Promedt Consulting GmbH
Altenhofstrasse 80
D-66386 St. Ingbert
Germany
Telephone: [phone]
Fax: [phone]
Email: [email protected]

1414
Section 1: Introduction
1.3 System Description
Nanoduct is a complete, integrated system for inducing and analyzing sweat for
cystic brosis (CF) diagnosis—all while attached to the patient. This reduces
the possibility of intrinsic error and enables pristine samples to be obtained from
neonates and analyzed in situ.
Nanoduct incorporates the classic method of inducing sweat by pilocarpine
iontophoresis. The pilocarpine is introduced into the skin of the patient using
controlled DC electrical current from the Nanoduct induction/analysis module.
This is followed by continuous-ow analysis using the unique sensor.
Results appear quickly on the display. During the process the operator installs
and then removes the various components that t in the holders described later.
A description of the various components of the Nanoduct system follows.
Holders
Two plastic holders are attached to the patient with comfortable but secure non-
latex elastic straps. These holders accept the electrodes and later the sensor,
holding them securely against the patient’s skin. Holders are color-coded, one
red to accept the (positive) anode and subsequently the red sensor; the other
black to accept the (negative) cathode. Strap retainers are pushed through the
holes in the strap to maintain the correct tension.
Iontophoretic Electrodes
Two color-coded electrodes, one red for the anode (positive) and the other black
for the cathode (negative), are otherwise identical, both having a small stainless-
steel disc as the electrode plate.
These electrodes are part of the electrode cable assembly (see below) that
also includes the sensor cell connector to attach the separate sensor cell. Both
electrodes have projecting anges, for securing the electrodes in the holder
rings. Electrodes provide current from the module through Pilogel discs during
iontophoresis. The black cathode electrode also serves as an electrical reference
to detect sweat ow to the sensor cell during the analysis phase.
Electrode Cable Assembly
This dual-purpose 1.8 m long cable assembly includes the red anode and black
cathode iontophoretic electrodes and the red sensor cell connector. The cable
connects to the Induction/Analysis Module at the electrode connection socket on
the top of the instrument.
Inspect lead wires periodically for breaks or cracks in the insulation. Replace
the electrode set if any cracks or breaks are apparent in the electrode wires,
insulation or plastic housing.

1515
Section 1: Introduction
Pilogel Iontophoretic Discs
Pilogel discs are small (surface area 2.5 cm2) iontophoretic discs that are
inserted into the electrode assemblies before iontophoresis. Designed especially
for neonates, these discs have a pilocarpine concentration of 1.5% for optimum
stimulation of the sweat gland, which also reduces the iontophoresis time to
approximately 2.5 minutes.
Pilogel discs contain su󰀩cient glycerol to provide substantial protection of gels
against damage from accidental freezing. Cracked discs due to freezing can
contribute to burns. Refer to the appendix for more information.
Pilogel discs contain trisodium citrate, an excellent bu󰀨er in the acid range of pH.
This reduces anodic acidication of the gel during iontophoresis by 90%. At the
cathode, the increased pilocarpine, a good bu󰀨er at moderately alkaline pH, also
reduces iontophoretic accumulation of alkali. This bu󰀨ering prevents skin burns
due to pH change in the gel. Each of these features contributes to the safety of
the procedure. Refer to Appendix H for important information about pilocarpine
iontophoresis.
In areas where Pilogel discs are not available, users should check with
ELITechGroup for the availability of ber pilocarpine reservoirs of the same
size as Pilogel discs, for use with pilocarpine solutions supplied by the
user.
WARNING!
Pilogel discs should be refrigerated at 2 to 8 °C. DO NOT FREEZE. Never
use discs that have been frozen or that are cracked. This does NOT apply
to ber pilocarpine reservoirs.
WARNING!
Pilogel is considered toxic, as is pilocarpine nitrate in other forms. Do not
ingest. See Appendix D, E, or the SDS.
Sensor Cell
Color-coded red, the sensor has two external anges (as with the electrodes) for
latching to the red holder. The base of the sensor is a shallow concavity leading
at its center to an entry port, and from there to a ne internal channel passing by
two analyzer micro-electrodes, forming a micro conductivity cell.
The sensors pass through stringent quality controls before shipment to the
customer. To be accepted, sensors must be highly consistent throughout each
batch.
Pilogel
Iontophoretic
Discs

1616
Section 1: Introduction
Induction/Analysis Module
The battery-operated electronic induction/analysis module controls the Nanoduct
system. The module performs six separate functions:
1. Provides a timed and controlled current for iontophoretic sweat stimulation.
2. Measures electrical conductivity of the excreted sweat during the analysis
phase.
3. Automatically averages the conductivity reading over a dened 5-minute
period.
4. Automatically computes the initial sweat rate.
5. Displays the above information on the LCD readout and reports sweat test
and calibration results to the serial port.
6. Provides a time and date display for calibration and test results.

1717
Section 1: Introduction
1.4 Controls and Connections
Electrode Socket
The electrode socket on the top of the enclosure connects the electrode/sensor
cable assembly to provide electrical current for sweat stimulation and to receive
sensor signals to the induction/analysis module during the analysis phase.
Keypad Keys
ON
The ON key turns the instrument on when pressed. The ON key is also used in
conjunction with the SELECT key to access the Setup Menu.
OFF
The OFF key powers the instrument o󰀨. Pressing the OFF key cancels all
operations and turns power to the module o󰀨.
NOTE: To preserve battery power, leave power o except while performing a
test. During idle periods the instrument shuts down automatically after 10 minutes
and must be turned on again to complete testing or retrieve a result.
SELECT
The SELECT key scrolls through menu selections and increments parameter
settings. Use the SELECT key in conjunction with the ON key when accessing
the SETUP MENU.
ENTER
The ENTER key selects menu selections, advances through menu screens, and
starts the iontophoresis and analysis phases of the sweat test. A warning tone
sounds if a fault condition occurs–such as an open electrode or circuit fault. The
fault condition is displayed and reset by pressing ENTER.
Display
The LCD alphanumeric read-out displays all functions and results as they occur,
including iontophoresis status and analysis results, plus the time and date of the
last procedure. The user responds to prompts on the display to activate various
functions. The instrument emits a short beep tone at the start and end of each
operation.
The instrument displays conductivity measurements in mmol/L (equivalent NaCl)
during analysis. If desired, display readings can be suppressed so readings are
not visible, but can be recalled later.
Low Battery Indicator
If the battery voltage drops below a preset level at power-up, a “Low Battery”
message appears on the display. When this indicator rst appears, it is possible
to complete a small number of tests before replacing the batteries. If battery
power is too low to complete a test, the module automatically shuts o󰀨 and
iontophoresis cannot be started. The batteries must be replaced to continue.
Refer to Section 2.1 to replace the batteries.
NOTE: Use only four standard alkaline AA cells to power the Nanoduct. Using
other types of AA cells may cause low battery indicator inaccuracy.
LOW BATTERY
YYYY-MM-DD HH:MM
Check Controls
Iontophoresis
Sweat Analysis
Recall Reading

1818
Section 1: Introduction
Serial Data Ports
RS-232 Port
The Nanoduct RS-232 port uses a DB9 connector located on the top of the
instrument. This port is for asynchronous serial communication with a printer or
computer. The RS-232 port can be used to print out results of sweat tests (with a
time and date stamp). Data output is in ASCII characters. Refer to Appendix C for
additional information.
WARNING!
Electrical shock hazard. Never connect to a line powered printer or
computer when the instrument is attached to a patient.
USB Port
The Nanoduct Universal Serial Bus (USB) port uses a standard USB type-B
receptacle. The port is congured as a USB device (not a host). Data output is
in ASCII characters. The USB port allows the updating of rmware in the eld
and allows a reading to be transferred to the Nanoduct Lab Report application.
The port cannot be used with a USB printer. Refer to Appendix C for additional
information.
WARNING!
Electrical shock hazard. Never connect to a line powered printer or
computer while the instrument is attached to a patient.

1919
Section 1: Introduction
Model/Serial Number Identication Label
The following label is located on the back of the instrument.

2020
Section 1: Introduction
User Interface Block Diagram