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TECIL ISEsweatII User Manual

Sweat chloride analyzer
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ISEsweat II
Sweat Chloride Analyzer
User's manual
V00EVP012014

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Summary of Contents for TECIL ISEsweatII

  • Page 1 ® ISEsweat II Sweat Chloride Analyzer User’s manual V00EVP012014...

  • Page 3: Table Of Contents

    INDEX INTRODUCTION ........................5 ISEsweat intended use.................... 6 Operating principles ....................6 How to use this manual ..................7 DEVICE DESCRIPTION ......................8 ISEsweat ........................ 9 Terminal or receiver base ..................10 Remote module ....................11 SENSOR CARDS ..................... 12 ISESWEAT INSTALLATION ....................
  • Page 4 ANNEX A: TROUBLESHOOTING TABLE ................... 38 ANNEX B PRODUCT SPECIFICATIONS ..................40 ANNEX C POSSIBLE INTERFERENCE ..................43 ANNEX D RECOMMENDATIONS FOR THE RESULTS INTERPRETATION ...... 45 ANNEX E SYMBOL DEFINITIONS ....................47 ANNEX F REGULATIONS ....................... 50 ANNEX G MANUFACTURER DECLARATION ................53 ANNEX H WARRANTY ........................

  • Page 5: Introduction

    INTRODUCTION...

  • Page 6: Isesweat Intended Use

     ISEsweat - User’s Manual ISEsweat intended use ISEsweat is intended for quantitative pilocarpine iontophoresis sweat chloride testing for the diagnosis of cystic fibrosis. ISEsweat should only be used by Doctors, nurses and trained laboratory personnel. It is highly recommended that users gain prior experience before diagnosing Cystic Fibrosis. The place for testing may be in laboratories, hospitals or clinics In order to increase the possibility of collecting an adequate sweat sample, it is advisable to conduct the first chloride sweat determination tests on individuals older than 2 weeks and...

  • Page 7: How To Use This Manual

    The analyzer measures the electrode potentials, and the data is processed by a microprocessor to calculate the chloride ion concentration. How to use this manual This user manual has been produced by Tecil in order to guarantee the correct use of the ® ISEsweat equipment.

  • Page 8: Device Description

    Device description...

  • Page 9: Isesweat

    2. Remote module, has just one push button on the front. This remote module has the holder for the innovative disposable sensor card patented by Tecil which are involved with the stimulation, sweat collection and reading the chloride concentration obtained from the patient’s sample.

  • Page 10: Terminal Or Receiver Base

     ISEsweat - User’s Manual Terminal or receiver base Receiver unit for the reception of data coming from the remote analyzer module, display and record in the internal data base memory Display: Appears all the information about Display Base LED indicator the test ( phase, time remaning…) Base LED:...

  • Page 11: Remote Module

     ISEsweat - User’s Manual Remote module Remote LED indicator: Indicates the phase of sweat test, and if there’s some Remote push problem, using a two colour LED. button Charge LED indicator: Indicates if it’s charging (orange) fully charged Remote LED (green).

  • Page 12: Sensor Cards

     ISEsweat - User’s Manual SENSOR CARDS ® ISEsweat uses a sensor card to run the analysis or sweat test. It consist of two different sides; each one performs a different process (IONTO side and MEASURE side). The name of each side alludes to its function. Once the card package is opened, you can distinguish these two sides by the appearance, thus making it difficult to make a mistake when choosing the approriate side.

  • Page 13: Isesweat Installation

    ISEsweat installation...

  • Page 14: Components

    IEC EN 60601-1-1 and EN 60601-2 Regulations for electromagnetic compatibility. All accessories supplied by TECIL comply with all these regulations. Connect the equipment to a power supply with an earth connection.
  • Page 15  ISEsweat - User’s Manual CAUTION: DO NOT soak the equipment in water or put it in a very high humidity area. CAUTION: In order to guarantee patient security and that the equipment remains in good ® condition, DO NOT place the ISEsweat in any place from where it could easily fall.

  • Page 16: Battery

     ISEsweat - User’s Manual Battery ® The ISEsweat transmitter module or remote includes a Lithium-ion (Li-ion) battery with a 650mAh capacity that allows it to work. When completely charged the battery will last for 6 hours and allow for 10 analyses. It is highly recommended that the internal battery is replace every 2 or 3 years, depending on the use.
  • Page 17  ISEsweat - User’s Manual However, connection refers to the starting up/shutting down of the remote module using the switch at the lower side. If the remote is shut down it won’t work; there is no power. To start the charging process, please follow the instructions below: 1.
  • Page 18 Remote indicator LED will emit a RED light if the battery state is not good, thus showing a problem in the battery. CAUTION: Battery replacement can only be made by the TECIL Technical Support team or a TECIL authorized technical expert.

  • Page 19: Sweat Analysis

    Sweat analysis...

  • Page 20: Settings

     Normal Mode, designed to run the analysis or sweat test.  Quality Control Mode ( ISEtrol N or ISEtrol A ), designed to check the equipment. It is recommended to use TECIL controls or any other approved QC material for this. Work Mode Selection ...
  • Page 21  ISEsweat - User’s Manual  Choose the correction factor that shows in the sensor card box, if there is not any specified on the box, choose 5. Skip through this by pressing <ENT> An information screen on the linking between the base and the remote will appear automatically, and the device will proceed to the linking.

  • Page 22: Sweat Induction And Analysis

     ISEsweat - User’s Manual Sweat induction and analysis PREVIOUS PHASE Follow the instructions on the screen: Insert sensor 1. Select a card and take it out of the package 2. Remove the protective film plastic that protect the connectors. Dry any excess liquid from the connections zone with a tissue 3.
  • Page 23  ISEsweat - User’s Manual CAUTION: Skin must be healthy, wholesome, with no cuts, eczemas or irritations. Whenever you clean the skin with alcohol, remember to moisturize it afterwards, to avoid skin dryness caused by alcohol 6. Place the card with the hydrogels on the skin pretreated with alcohol and destilled water, so there is contact between them and the patient’s inside forearm.
  • Page 24  ISEsweat - User’s Manual Sweat Test On pressing <ENT>, a new screen appears which allows the analysis to be monitored. The analysis consists of 4 phases: Phase 1: Preparation ® The ISEsweat base unit will emit a repetitive sequence of 3 fast beeps, waiting for the user’s confirmation.
  • Page 25  ISEsweat - User’s Manual 6. Clean the stimulated zone with deionized water and then dry it. CAUTION: DO NOT clean the stimulated zone with physiological saline or any other saline solution, since it can affect the test results. 7. Replace the protective plastic covering over the IONTO gels.
  • Page 26  ISEsweat - User’s Manual 11. Place the remote unit onto the patients skin with the electrodes aligned over the stimulated zone. IMPORTANT: Keep the remote unit in the same position and direction as it was before to ensure that the measure area is placed directly over the previously stimulated area.

  • Page 27: Interpreting Of Sweat Test Results

     ISEsweat - User’s Manual Results Once the data has been transmitted, the base screen will show the value Chloride concentration in mmol/l. The screen message has a reminder that, after ending the analysis, you have to: 1. Remove and discard the sensor card (see Waste Management). 2.

  • Page 28: Quality Control Mode (Qc)-Isetrol N And Isetrol A

    (see Technical Specifications section). CAUTION: TECIL not responsible for any problems arising from the use of a control in poor condition or unsuitable for the technique or device. Therefore, before using a control, you should consult with TECIL as to its compatibility with the ISEsweat.
  • Page 29 Get in touch with TECIL for instructions on possibly changing the cards, or the control, or the device.

  • Page 30: Data Port Use

    Data port use...

  • Page 31: General Summary

    WARNING: Epson Printer TM-U220DS is certificated according to EN 60601-1-1. The serial port is designed for this printer. Do not use any other printer. If you have any doubt, please check with TECIL Technical Support Service. CAUTION: When connecting any peripheral equipment, either the printer or the PC, to ®...
  • Page 32  ISEsweat - User’s Manual ® series to the ISEsweat data port connector (4). 2. Turn on the printer. At the end of each analysis, data is sent in real time and continuously to the data port at the ® back of ISEsweat Each analysis results (both Sweat Test and QC) is seen on screen and is simultaneously transmitted to the communication outputs at the back of the device...

  • Page 33: Memory

     ISEsweat - User’s Manual Memory ® The ISEsweat memory is capable of storing up to 50 results that can be printed out later or sent via the USB port to a computer connected to the base. To open the MEMORY menu, press <MEM> at the buttons below the Start Screen. ...
  • Page 34  ISEsweat - User’s Manual  Choose PC Link using scroll arrows (↓↑) and press <ENT> in order to send the stored results via the USB port to a computer connected to the base.  Choose Delete memory using scroll arrows (↓↑) and press <ENT> to delete all stored results.

  • Page 35: Maintenance

    Maintenance...

  • Page 36: Technical Service

    TECIL logistics department within 24 hours of receipt. If you are returning goods to TECIL get in touch with TECIL Technical Support Service to get shipping instructions. Unless TECIL Technical Support Service says otherwise, you don’t ®...

  • Page 37: Waste Management

    Phone: + 34 902995746 Fax: +34 933084871 TECIL staff will give you local contact details for product disposal, or instructions to ship the product back to TECIL. ® CAUTION: The ISEsweat uses single-use sensor cards. Once used, they must be discarded.

  • Page 38: Annex A: Troubleshooting Table

    ANNEX A: Troubleshooting Table...
  • Page 39 If the device suffers electronic failure or the remote light signals do not go on after charging the battery, please contact the technical support service of TECIL or your local distributor. If there are any of the problems listed in Table 4, follow the instructions given.

  • Page 40: Annex B Product Specifications

    ANNEX B Product Specifications...
  • Page 41  ISEsweat - User’s Manual Technical specifications CAUTION: DEVICE ADJUSTMENTS ARE NOT ALLOWED. This device does not require any kind of internal calibration. Output Minimum sample volume 10 microliters Precision +3 mmol/l Limit of Detection 3 mmol/l Range 5 to 150 mmol/l Repeatability (CV) CV <...
  • Page 42  ISEsweat - User’s Manual Background conditions Device: keep between 18ºC and 35ºC Storage conditions Cards: keep between 2ºC and 8ºC Environmental use conditions 18ºC – 35ºC, Humidity 50 – 80% Physical features Dimensions Base Width: 150 mm, Long: 195 mm. High: 60 mm Remote module Width: 556 mm, Long: 75 mm, High: 22 mm Receiver base weight...

  • Page 43: Annex C Possible Interference

    ANNEX C Possible interference...
  • Page 44  ISEsweat - User’s Manual Recommendations to realize the sweat test to a patient: 1. To carry out the sweat test without any problem the patient should not be having administered intravenous fluids in a shorter period of 24h 2. The patient should not have been treated with any medicines that contain corticosteroids in a period less of 24h.

  • Page 45: Annex D Recommendations For The Results Interpretation

    ANNEX D Recommendations for the results interpretation...
  • Page 46  ISEsweat - User’s Manual Causes for repeating the sweat chloride determination (Sweat Test)  All positive results of chloride in sweat must be repeated and confirmed with the mutation determination. CF diagnosis should not be based in only one positive test. ...

  • Page 47: Annex E Symbol Definitions

    ANNEX E Symbol Definitions...
  • Page 48  ISEsweat - User’s Manual General symbols Electrostatic On/ Off USB Dock discharge Applied part: Selective refuse collection. RS232 Type BF Do not throw to regular trash. Packaging symbols Keep away from Read carefully sunlight Irritant instructions of use. Manufacturer Expiration date Batch Code Ex: 2010 –...
  • Page 49  ISEsweat - User’s Manual ® Symbols on the ISEsweat screen (top right) Battery: Charged Battery at Flat battery battery medium/low level Radio Coverage: Correct coverage Coverage at medium/low level No coverage...

  • Page 50: Annex F Regulations

     ISEsweat - User’s Manual ANNEX F Regulations...
  • Page 51  ISEsweat - User’s Manual This product has been designed and manufactured in accordance with U.S. and European regulatory requirements as out-lined below. Modifications made to this product that are not expressly approved in writing by the manufacturer will void the user’s authority to operate this product, previously issued factory approvals, and the user’s rights under the warranty.
  • Page 52  ISEsweat - User’s Manual Federal Communications Commission (FCC) Statement 15.21 You are cautioned that changes or modifications not expressly approved by the part responsible for compliance could void the user’s authority to operate the equipment. 15.105(b) This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC rules.

  • Page 53: Annex G Manufacturer Declaration

    ANNEX G Manufacturer declaration...
  • Page 54  ISEsweat - User’s Manual This product complies with the EN/IEC 60601-1-2:2008 regulation. ® CAUTION: Use of accessories, sensor cards and cables that are not specific for ISEsweat can lead to increased electromagnetic emissions and greater susceptiblility to interference. This can also cause inexact readings. The Power supply included with the device is medical grade.
  • Page 55  ISEsweat - User’s Manual NOTE: U Var % is the network CA tension before applying the test level (230 V / 50 Hz). Susceptability IEC Test level Performance Electromagnetical environment test 60601 level - Guideline Electrostatic Floor must be made of wood, Direct contact of ±6 kV discharge concrete or wooden tiles.

  • Page 56: Annex H Warranty

     ISEsweat - User’s Manual ANNEX H Warranty...
  • Page 57 TECIL,S.A. guarantees to repair or replace free of charge parts and pieces with working failures due to manufacturing causes for 24 months after delivery, as well as providing all labour needed to repair them. All parts that have been replaced when repairing the unit will automatically become property of TECIL,S.A.

  • Page 58: Annex I History Sweat Test

     ISEsweat - User’s Manual ANNEX I History Sweat Test...
  • Page 59 CFF as screening method but only for use outside accredited Cystic Fibrosis Care Centers. In 2010 Tecil introduced ISEsweat®, a new method for direct sweat Chloride measurement who eliminates all intrinsic sources of error associated to collection methods and with microISE specifically designed for microsamples.

  • Page 60: Annex J Reference

     ISEsweat - User’s Manual ANNEX J Reference...
  • Page 61 1. Grosse, Scott D., Ph.D.; Boyle, Coleen A., Ph.D.; Botkin, Jeffrey R., M.D.; Comeau, Anne Marie, Ph.D.; Rosenfeld, Margaret M.D.; Wilfond, Benjamin S., M.D.; Newborn Screening for Cystic Fibrosis. Morbidity and Mortality Weekly Report (MMWR), October 15,2004 / Vol. 53 / No. RR-13. 2.

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