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 specic 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 Notied Body number above signies that British Standards Institute BSI has certied 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 certicate, 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 certicate or the BSI
Notied 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 Congure 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 Specications 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 qualied 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)
Classication
This equipment is classied 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).
Specication of Safe Use
Using this equipment in a manner not specied 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.
Specic 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 inammation (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 qualied 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 specied by ELITechGroup should be used with this
device. Using non-approved parts may aect the performance and safety features of the device.
If the device is used in a manner not specied 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 debrillator, 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.
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