MACRODUCT SWEAT COLLECTION SYSTEM - …

1 MACRODUCT SWEAT COLLECTIONSYSTEM instruction/service manualM 2551-7 rev ACOPYRIGHT 2004 WESCOR, INCM odel 3700 User's Manual Overview .. To Our Valued Customers .. Important User Information .. SYSTEM Webster SWEAT Pilogel Iontophoretic MACRODUCT SWEAT Collector .. 16section2 SWEAT INDUCTION Inducing Collecting SWEAT .. Abbreviated 33section3 SWEAT An overview to SWEAT Analysis .. 37 TABLE OF CONTENTS ivsection4 TROUBLESHOOTINGAND Troubleshooting Cleaning the Replacing Inducer 45 APPENDIX ASpecifications .. 49 APPENDIX BSupplies and Replacement 53 APPENDIX CA Perspective on the SWEAT Test .. 60 TABLE OF CONTENTS1 SECTION1 INTRODUCTION23 SECTION 1 INTRODUCTION This manual covers the complete laboratory procedure for the laboratorydiagnosis of cystic fibrosis through examination of SWEAT electrolyte con-centration.

2 The steps preliminary to SWEAT analysis SWEAT stimulationand COLLECTION , are accomplished using the MACRODUCT SWEAT User's Manual OverviewCAUTION!Never attempt SWEAT COLLECTION until you arethoroughly familiar with the procedures and cau-tionary information detailed in this instructions printed elsewhere areprovided for reference only and should not beused as a substitute for the complete informa-tion contained in this you for purchasing the MACRODUCT SWEAT COLLECTION SYSTEM . We areconfident that this is the finest SWEAT testing SYSTEM in the world. As theacknowledged world leader in SWEAT testing products for the laboratory diag-nosis of cystic fibrosis, Wescor is dedicated to providing customer support inall aspects of the use of this product and SWEAT testing theory and the beginning, our goal has been to identify problems in SWEAT testing,delineate the precise cause of false diagnosis, and then to devise innovativesolutions.

3 We have accomplished this with the added benefit of vastly simpli-fying procedures while remaining within the strict boundaries of is ready to help you resolve any difficulty with the operation or per-formance of the MACRODUCT SYSTEM . If you cannot resolve a problem usingthe information in this manual, please contact Inc. 459 South Main StreetLogan, Utah 84321-5294 USATELEPHONE: 435 752 6011 TOLL FREE: 800 453 2725 FAX:435 752 NOTE:Wescor s Authorized European Representative for matters relating to the MedicalDevice Directive is:MT Promedt Consulting GmbHAltenhofstra e 80D-66386 St. Ingbert, GermanyTel. +49 6894 581020 Fax +49 6894 581021email 1 INTRODUCTION To Our Valued CustomerAPPLICATION:The MACRODUCT SYSTEM is intended for laboratory use by qualified personnel forstimulation and COLLECTION of SWEAT for analysis in the diagnosis of cystic fibrosis.

4 Anyone operating MACRODUCT must be thoroughly familiar with the proce-dures and cautionary information detailed in this manual before attempting touse this equipment. SPECIFICATION OF SAFE USE:Using this device in a manner not specified by Wescor, Inc may impair the safetyprotection designed into the equipment and may lead to injury. Do not use whereflammable anesthetic is present or in any oxygen-enriched OF ENVIRONMENTAL LIMITS:This equipment is designed to be safely operated at 5 to 35 C, maximum relative humidity 80%.EXPLANATION OF SYMBOLS FOUND ON EQUIPMENT:IRunOStopInternational Attention attention to important information andinstructions in the user s BF equipment complying with Medical Equipment SafetyStandard Flow IndicatorLow Battery IndicatorSECTION 1 INTRODUCTION Important User Information6 Supply Kit for 6 SWEAT tests 12-Pilogel Discs,6 - MACRODUCT SweatCollectors6-Small SealablecontainersWebster SweatInducerNippersVelcro ElectrodeAttachment Strap(red)Velcro ElectrodeAttachment Strap(black) SWEAT DispenserMacroduct Strap, ExtraLarge (39 cm) MACRODUCT Strap,Large (25 cm) MACRODUCT Strap, Medium(18cm) MACRODUCT StrapSmall (14 cm)

5 Electrode SetSECTION SYSTEM Components7 SECTION 1 INTRODUCTIONCATALOG NUMBER 3700-SYSDESCRIPTIONUNITCATALOG SWEAT Inducer1 eachModel 3700 Electrode Set1 each320566 Electrode Attachment Strap (red)1 eachRP-044 Electrode Attachment Strap (black)1 eachRP-045 Supplies kit for 6 SWEAT tests (12-Pilogel Discs,1 eachSS-0326- MACRODUCT SWEAT Collectors,6-Small Sealable containers) SWEAT Dispenser1 eachRP-065 Nippers1 eachRP-066 MACRODUCT Strap, Small (14 cm)1 eachSS-128 MACRODUCT Strap, Medium (18 cm)1 eachSS-129 MACRODUCT Strap, Large (25 cm)1 eachSS-130 MACRODUCT Strap, Extra Large (39 cm)1 SYSTEM Components8 The Webster SWEAT Inducer is an integral part ofthe MACRODUCT SWEAT COLLECTION SYSTEM .

6 Its designis based on years of clinical experience, research,and product development, with patient safety andcomfort given paramount importance. It is a fullyautomatic unit featuring advanced electronic cir-cuitry and many fail-safe and operator conve-nience It WorksWhen the RUN/STOP switch is moved to the I position,a brief tone signals that external electrodecircuit resistance is acceptable and that the instru-ment has begun to deliver iontophoretic delivery is confirmed by a green CURRENTFLOW INDICATOR. The tone sounds again briefly atthe completion of current rises to mA during a 17-30 second interval, remains at mA for 5 min-utes, then decreases in the final 6 seconds to zero,at which time the instrument switches off.

7 This"profiling" of iontophoretic current prevents thesensation of electrical shock that results when cur-rent changes abruptly. The CURRENT FLOW indi-cator is wired in series with the the complete iontophoretic sequence, thetotal electrical charge delivered to the positiveelectrode is approximately 450 millicoulombs or 78millicoulombs/cm2. Due to impurities in the agar,Pilogel discs contain sodium and other cations intotal molar concentrations approximately equal tothat of the pilocarpinium ion. These therefore com-pete with each other for transport of electricalcharge which produces an approximately 50%reduction in the amount of pilocarpine that wouldhave been delivered to the glands in the absenceof such salts.

8 However, sufficient drug is transport-ed to produce maximal SWEAT 1 Webster SWEAT Inducer3700 WEBSTER SWEAT INDUCER3700 WEBSTER SWEAT INDUCER9 FAULT CONDITIONSTo maximize safety, the inducer continuously mon-itors the current. If an unexpected condition isdetected the current turns off and an alarmsounds. This alarm continues until you move theswitch to STOP(0). A fault condition can occur if one of the electrodesbecomes detached. An alarm may also be due tolow batteries, (see next page). See Section 4 formore detail of fault conditions and Webster SWEAT Inducer10 LOW BATTERIESThe alarm sounds if the batteries are low when theswitch is moved to RUN(I). In this case, the amberLOW BATTERY indicator will also be illuminated,and the inducer will not start.

9 The alarm continuesuntil the control switch is moved to the STOP(0) batteries get low during iontophoresis, the instru-ment completes the cycle using remaining powerin the batteries, but at the end of the cycle, thetone sounds and the LOW BATTERY indicatorflashes. To disable the LOW BATTERY alert, pushthe switch to the STOP(0)position. Replace batteries before attempting anotheriontophoresis cycle. See Section 1 Webster SWEAT Inducer3700 WEBSTER SWEAT INDUCERLOWBATTERYCURRENT FLOWSTOP3700 WEBSTER SWEAT INDUCERRUN!3700 WEBSTER SWEAT INDUCER11 SECTION Webster SWEAT InducerWipe Stainless SteelElectrodesCheck for cracks in lead wires3700 WEBSTER SWEAT INDUCERELECTRODESThe high-grade stainless steel electrodes requireonly minimal maintenance.

10 This consists of clean-ing them with purified water after each use so theywill be ready for the next procedure (See ). Lead wires should be periodically inspectedfor breaks or cracks in the insulation. If electrodewires, insulation, or the plastic electrode housingexhibit cracks or breaks the electrode set shouldbe :If you activate the run switch while the electrodesare not attached to the patient s limb, an opencircuit alarm will sound. To disable the open cir-cuit alarm, push the switch to the STOP 1 Pilogel Iontophoretic DiscsThe traditional reagent solutions for pilocarpineiontophoresis are pilocarpine nitrate and sodiumnitrate. These have been applied either toabsorbent fabric (such as gauze) or to discs ofthick paper that are then interposed between theelectrode surfaces and the skin.