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©2018 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™, Sweat-Chek™, and EasyDuct™ are trademarks of ELITechGroup Inc.

Wescor®, ChloroChek®, Chloridometer®, 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 specific 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

The Notified Body number 2797 above signifies that British Standards Institute BSI has certified

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 certificate, CE 59518, is:

The manufacture of sweat analysis systems for cystic fibrosis; and sweat inducers (to obtain

samples for use in the subsequent laboratory diagnosis of cystic fibrosis).

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 certificate or the BSI Notified Body Number 2797 applies.

Macroduct Advanced Sweat Collector patent number:

US9226730 B2

Also published as:

EP2973536A2, US20140276220, WO2014145904A2, WO2014145904A3

2797

Содержание MACRODUCT ADVANCED 3710 SYS

Страница 1: ...MACRODUCT ADVANCED MODEL 3710 SYS USER S MANUAL Sweat Collection System...

Страница 2: ......

Страница 3: ...MACRODUCT ADVANCED SWEAT COLLECTION SYSTEM Model 3710 SYS User s Manual 57 0192 01E Last update 17 June 2021...

Страница 4: ...iability 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 The Notified Body number 2797 above signifies that Br...

Страница 5: ...dle with 1 cc Syringe 17 Figure 12 Sweat Dispenser 17 Figure 13 USB Cable 17 Figure 14 Electrode Cleaning Pads 17 1 3 Touchscreen and Operator Interface 18 Table 2 Main Function Icons 18 Table 3 Setti...

Страница 6: ...unctional Test Troubleshooting and Diagnosis 76 5 2 Cleaning the Electrodes 78 5 3 Cleaning the Device 79 5 4 Caring for the Macroduct Straps 80 5 5 Batteries Charging and Calibration 81 Primary Non r...

Страница 7: ...nternally Powered This device has been built and tested in accordance with safety regulations under EN 60601 1 3 1 edition In order to maintain this condition and ensure safe operation the operator mu...

Страница 8: ...ic 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 importa...

Страница 9: ...ould be used with this device including the battery charging power supply and power cord used for charging the device Using non approved parts may affect the performance and safety features of the dev...

Страница 10: ...anced Sweat Collection System consists of the Macroduct Advanced Model 3710 which is a microprocessor controlled device powered from a rechargeable lithium ion battery battery charging power supply an...

Страница 11: ...lector Pilogel discs and electrodes to better fit small arms neonate and toddler sized arms Complete patient mobility during sweat collection Easily confirmed sweat rate and total sweat yield gauged b...

Страница 12: ...f the device The designated background color for the safety sign is blue The label is printed in black and white only therefore the background color is black instead of blue but the meaning is the sam...

Страница 13: ...neral Symbol for Recovery Recyclable Environment Friendly Use Period Waste of Electrical and Electronic Equipment WEEE Symbol Under Directive 2012 19 EU this equipment cannot be disposed of in a norma...

Страница 14: ...ds package of 10 SS 271 4 Electrode Cable Assembly AC 203 5 Sweat Dispenser RP 065 6 Syringe 1 cc with EasyDuct Needle AC 193 7 Nippers RP 066 8 Macroduct Advanced Model 3710 9 AC Power Cord 10 Batter...

Страница 15: ...on the left side of the display Depending upon the screen the task bar allows access to Settings Home and context sensitive Help The battery charge level is displayed in the lower left corner A scree...

Страница 16: ...ttery is being charged A solid amber LED indicates that the battery is fully charged 2 Electrode Connector The electrode connector is a 6 pin push pull locking medical connector that mates with the el...

Страница 17: ...disc The electrodes provide current from the device through the Pilogel discs to the patient skin during iontophoresis Figure 6 Pilogel Discs Elliptical Pilogel discs are included in the SS 268 Macro...

Страница 18: ...weat samples for up to 72 hours when properly used The small sealable containers come packaged in a set of six enough for six tests and are intended for single use Figure 9 Collector and Electrode Str...

Страница 19: ...The sweat dispenser is an optional tool used to harvest and store a sweat sample in the small sealable containers The sweat dispenser uses a reduced end blunt needle for easy insertion into the colle...

Страница 20: ...Indicator Displays the amount of charge remaining in the battery Battery Low Indicator Indicates that the battery is low and should be recharged Cancel Cancels a process or function Forward Arrow Adva...

Страница 21: ...p Inactive Indicates the Stop icon is inactive or has already been pressed to stop the timer Exit Exits from a process Sufficient Sweat Rate Indicates that the sweat rate was sufficient operator selec...

Страница 22: ...e languages include English French German Italian Portuguese and Spanish Options Accesses the Options screen System Information Accesses the System Information screen Provides device specific informat...

Страница 23: ...value Slider Bar Sets the brightness of the display Progress Indicator Indicates that a process is in progress i e battery calibration discharge The icon rotates giving an indication that the process...

Страница 24: ...c current increases to 1 5 mA during an approximate 20 second interval remains at 1 5 mA for approximately 5 minutes then decreases in the final 5 seconds to zero This ramping of iontophoretic current...

Страница 25: ...less steel electrodes require only minimal maintenance This consists of cleaning the electrodes with isopropyl alcohol after each use so they will be ready for the next procedure It is recommended to...

Страница 26: ...sing an established safe and effective process Pilogel discs provide an air free continuous conduction medium and even distribution of current over the stimulated skin area reducing the possibility of...

Страница 27: ...lightly wet after washing the area where the electrode will be attached Or Add a drop of deionized water to either the skin or the Pilogel surface after installation in the electrode If a minor burn d...

Страница 28: ...titration or sweat conductivity analysis The dye contributes slightly to the osmolality and sodium content of the sweat sample Even with a low sweat yield of only 20 L this contribution will not exce...

Страница 29: ...lector can be over wrapped with an elastic bandage if needed Collects sweat passively and automatically driven by the natural hydraulic pressure of the sweat gland to the skin surface Notes Regarding...

Страница 30: ...rtment under the device Carefully unpack and inspect the device and accessories Check for damage that may have occurred during shipment Make sure everything is removed from the shipping package Contac...

Страница 31: ...ted to low temperatures below 0 C or high temperatures above 40 C let the device sit at room temperature for two hours before charging the battery WARNING The electrode cable assembly should not be at...

Страница 32: ...til the battery is fully charged 6 When the battery is fully charged the unblinking amber LED remains on 7 Disconnect the battery charging power supply from the device The Home screen displays Refer t...

Страница 33: ...Off press and hold the power switch for 2 3 seconds A pop up window shows three options Power Off performs an orderly power off process Tap Power Off a screen displays the power off progress the displ...

Страница 34: ...ff progress the display turns off and the device powers off Cancel cancels Power Off When Power Save is enabled the automatic power off process dims the display after 1 5 minutes of inactivity to cons...

Страница 35: ...ensitive help screens and the step by step iontophoresis procedure The Home screen also displays the battery charge level the date and time The icon displays the current charge level of the battery Ta...

Страница 36: ...information for recent tests Setting the Date Time Selecting Power Management options Selecting a Language Selecting the Options settings Selecting the Simulated Test mode of operation Tap on the desi...

Страница 37: ...mary Logs Functional Test Home Screen Battery Calibration Screen Brightness Power Save Power Management Required Information Tap Sounds Passcode Options Simulated Test System Portuguese Italian French...

Страница 38: ...iew System Logs Tap the desired selection to access that particular screen Tap to return to the Settings screen Tap to return to the Home screen The Functional Test The Functional Test combines the te...

Страница 39: ...llection time based on when the operator started and stopped the sweat collection timer grayed out if the sweat collection timer was not started The sufficient sweat rate grayed out if the sweat rate...

Страница 40: ...at the export has completed 3 Remove the USB drive from the device To export the system logs via the micro USB port to a computer do the following 1 Plug a USB drive into the micro USB port on the dev...

Страница 41: ...y tapping Power Save selected is the default setting With Power Save selected After a few minutes of no operator interaction the device gradually begins to power down The display dims and eventually t...

Страница 42: ...rate the battery indicator that displays the percent of battery charge level Refer to Section 5 5 for complete information When finished tap or to save the power management settings and return to the...

Страница 43: ...maximum of 8 digits After entering the passcode tap 3 Enter the passcode a second time to confirm Enter the passcode and tap The passcode is saved and the display returns to the Options screen Do not...

Страница 44: ...ut fields by tapping or next to the required information Operator Test Kit LOT The default is that none of the fields are required Any combination of the fields can be selected to be required NOTE The...

Страница 45: ...e in Simulated Test mode Verify that the device is in iontophoresis mode with blue task bar showing when performing an actual test When simulating a sweat test the device functions much like it would...

Страница 46: ...ive help function From any screen that displays the help icon tap to access the context sensitive help for that specific screen Depending upon the amount of information a scroll bar on the right side...

Страница 47: ...step setup procedure 3 Iontophoresis Supplies Make certain the device and all supplies are on hand for the complete sweat induction procedure Macroduct Advanced Model 3710 Electrode cable assembly Ele...

Страница 48: ...and return to the Enter Information screen The maximum number of characters for the Operator is 20 b Tap inside the Test field to access the keyboard Using the keyboard enter the Test identification a...

Страница 49: ...lug into the connector on the top panel of the device 6 Select Limb The skin at selected locations for attaching the electrodes must be free from breaks cuts observable abnormalities or signs of infla...

Страница 50: ...gorously with alcohol then rinse the area with a generous amount of deionized water b Leave the skin wet where the Pilogel disc is to be attached Or Place a drop of deionized water on the skin or on t...

Страница 51: ...erface with the Macroduct Advanced Sweat Collector If the limb is tiny place the red electrode on the upper portion of the flexor aspect of the forearm nearer the elbow or even the upper arm If the en...

Страница 52: ...ap around the limb and through the opposite slot on the electrode from the bottom through the slot and then down aligning a suitable hole in the strap with the attachment knob Press the selected hole...

Страница 53: ...on between the Pilogel disc and skin c Position the black electrode with a Pilogel disc at a suitable location on the same limb as the red electrode d Attach the strap to the other side of the black e...

Страница 54: ...eft of the screen shows the progress of the increasing current labeled mA After full current is reached the horizontal progress bar displays the progress of full current in seconds from 1 to 300 5 min...

Страница 55: ...lated skin and the surrounding area thoroughly with deionized water to remove salt then blot dry There should be a distinct redness under the red electrode b Proceed to the next step immediately by ta...

Страница 56: ...is cancelled the iontophoresis procedure must be repeated to completion before proceeding to sweat collection 3 Remove the electrodes and discard the Pilogel discs Tap to advance to the next screen 4...

Страница 57: ...able hole in the strap with the knob and then pressing the hole around and over the knob to lock it in place DO NOT TOUCH THE COLLECTION SURFACE c Tap to advance to the next screen or tap to go back t...

Страница 58: ...collector to the skin surface ensuring that the collector is still positioned over the sweat stimulated area Adjust strap tension on either side as needed to ensure even contact e For neonate sweat co...

Страница 59: ...n it reaches 30 minutes or when the sweat collector is close to being full of sweat The timer must be stopped before advancing to the next screen The icon indicates the timer has stopped b After the t...

Страница 60: ...uded but should NOT be used with the Sweat Chek Analyzer A standard 22 gauge blunt needle such as those included in SS 045 may be used instead of the EasyDuct needle if disposability is desired If usi...

Страница 61: ...ser or the nippers pry up the end of the tubing enough so the tubing can be grasped by hand Grasp the tubing and gently pull the tubing away from the collector body until the tubing is completely unco...

Страница 62: ...o determine if enough sweat was collected to confirm a sufficient sweat rate Below the bottom black line Insufficent sweat rate Sufficient sweat rate is defined as 1g m2 min which in terms of volume e...

Страница 63: ...ng motion d Tap to advance to the next screen or tap to go back to the previous screen Insert Needle Using the Sweat Dispenser a DO NOT squeeze the dispenser at any time while inserting the needle int...

Страница 64: ...e plunger down The sweat should move smoothly down and out of the tubing d Immediately close the cover to protect the specimen Or e If using the Sweat Chek Analyzer attach the end of the tube to the S...

Страница 65: ...Section 5 4 10 Clean and Dry Skin a Clean the skin and the area surrounding where the collector was attached thoroughly with deionized water then blot dry b Tap to advance to the next screen or tap to...

Страница 66: ...t and if there was an error The operator selected limb where sweat was collected Total sweat collection time based on when the operator started and stopped the sweat collection timer grayed out if the...

Страница 67: ...comfort during iontophoresis and the burn was not discovered until the electrodes were removed Most individuals exhibit sensitivity to pilocarpine that is typically manifested as mild erythema redness...

Страница 68: ...d insufficient sweat samples be pooled to achieve the volume required Chloride Analysis Sweat samples collected with the Macroduct Advanced can be analyzed for the sweat chloride level ELITechGroup pr...

Страница 69: ...device and Pilogel discs must be detected Possible Solutions Check that the Macroduct Advanced cable is securely connected Check both electrodes ensuring that a Pilogel disc is present and securely p...

Страница 70: ...maged Stop using the device and contact ELITechGroup Device immediately shuts off or the device shuts off during a test Probable Causes Low battery or battery is unable to hold a charge Possible Solut...

Страница 71: ...iological factors e g anhidrosis hypohidrosis If an adequate sweat sample is not obtained repeat testing should occur as soon as is practical This could be the same day or the following day The sweat...

Страница 72: ...robable Cause Pilogel is not present in the black electrode problem with the electrode cable assembly or a problem with the gel detect circuit on the device Possible Solutions Check the black electrod...

Страница 73: ...in the device Possible Solutions Contact ELITechGroup Event 1006 User Cancelled Iontophoresis Event happens when the operator cancels the iontophoresis test Error 1007 Disconnect Power Supply Probabl...

Страница 74: ...oblem persists with electrodes not attached to a patient try checking the electrodes from the System screen From the Home screen tap then tap System and then tap Functional Test Error 1011 2 Ramp Low...

Страница 75: ...is being used Check connections from the power supply to the AC outlet and from the power supply to the device Error 1017 Charging Error Battery Charge Timeout Probable Causes The maximum charge time...

Страница 76: ...er instructions Error 1022 Clean Red Electrode Probable Cause Red Electrode has a Pilogel film buildup Possible Solutions Clean Red Electrode with isopropyl alcohol If problem persists clean Red Elect...

Страница 77: ...screen tap Functional Test 2 Connect the electrode cable to the device 3 Place a single Pilogel disc between the two electrodes Use an electrode strap to hold them together 4 Tap to begin the test 5 A...

Страница 78: ...nal test multiple times trying the possible solutions If the problem persists contact ELITechGroup for further instructions Gel Detect fails Errors 1001 1002 or 1003 Probable Causes Pilogel discs are...

Страница 79: ...solutions If the problem persists contact ELITechGroup for further instructions If the problem seems to be intermittent try wiggling and pulling gently on the wires and cable during the test If this...

Страница 80: ...at could leave a chloride residue 3 Wipe each electrode dry 4 When using a new Macroduct Advanced Supply Kit SS 268 or if the electrode appears dirty after an extended idle period use the Electrode Cl...

Страница 81: ...e Clean the device after using it with a patient Wipe down the exterior of the device using any of the following methods Disinfecting laboratory wipes Isopropyl alcohol 70 ethanol or alcohol wipes CAU...

Страница 82: ...euse the straps do the following to clean the straps 1 Soak the straps in 70 Isopropyl alcohol for 1 5 minutes 2 Rinse soaked straps thoroughly 2 to 3 times in deionized water 3 Allow to air dry high...

Страница 83: ...ightness setting and whether or not Power Save is enabled The Battery Indicator appears in the bottom left hand corner of the display Just below the approximate of remaining battery charge is displaye...

Страница 84: ...re operating the device Typical charge time is approximately 4 hours for a fully discharged battery Higher environmental temperatures will extend battery charging time NOTE When the battery is low cha...

Страница 85: ...charge can take up to 13 5 hours After complete discharge if the display is on Connect Power is displayed If the display is off connect the power supply or press the Power Switch to turn the device on...

Страница 86: ...harge and will be able to run fewer tests between charges WARNING Replacement by inadequately trained personnel and or substituting incorrect cells could result in a hazard such as excessive temperatu...

Страница 87: ...posed of as follows Under Directive 2012 19 EU WEEE this equipment cannot be disposed of in municipal waste Instead the equipment must be disposed of either by 1 Routing to an authorized local facilit...

Страница 88: ...rodes as described in Section 5 2 2 Wipe down the exterior of the device as described in Section 5 3 3 Discharge battery to approximately one half or less of the full charge by leaving the device on a...

Страница 89: ...n this manual please contact ELITechGroup s Service Department to help resolve any questions about the operation or performance of your Macroduct Advanced system Customers in the United States should...

Страница 90: ...ion of a physician s diagnosis of cystic fibrosis Contraindications Do not apply to broken or damaged skin surface Do not use on patients that have a known sensitivity or allergy to any ingredient Ide...

Страница 91: ...th the following Hazard and Precautionary statements The associated signal word is Warning Hazard Precautionary Statement H302 Harmful if swallowed P102 Keep out of reach of children P264 Wash hands f...

Страница 92: ...510 Electrode Cable Assembly Macroduct Advanced AC 203 USB Cable RP 538 Medical Grade Power Supply and Power Cord for Battery Charging Power Supply and 120 V Power Cord RP 539 Power Supply and EU Pow...

Страница 93: ...nsing 79 5 kPa 2000 m Storage Temperature 2 C to 40 C 36 F to 104 F Transportation Temperature 10 C to 50 C 14 F to 122 F Audible Indicator Magnetic Buzzer 2 4 KHz typical Electrode Cable Assembly Ell...

Страница 94: ...or later Safety Compliance IEC EN 60601 1 3 1 Edition or later Input Voltage Range 100 VAC to 240 VAC 10 50 60 Hz Input Connector 2 pin IEC 60320 C8 Output Power typical 20 30 Watts Output Voltage 4...

Страница 95: ...is begins the resistance is high but rapidly reduces as the ducts begin to carry salt containing sweat to the skin surface In the majority of cases the standard pre cleaning procedure will suffice Rub...

Страница 96: ...Collection System should assure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment guidance RF Emissions CISPR 11 Group 1 The Macroduct Advanced system uses...

Страница 97: ...ion 1 KHz sine 710 745 780 9 Pulse Modulation 217 Hz 710 745 780 9 Pulse Modulation 217 Hz 810 870 930 28 Pulse Modulation 18 Hz 810 870 930 28 Pulse Modulation 18 Hz 1720 1845 1970 28 Pulse Modulatio...

Страница 98: ...ortable and mobile RF communications equipment transmitters and the Macroduct 3710 as recommended below according to the maximum output power of the communications equipment Rated maximum output power...

Страница 99: ......

Страница 100: ...ELITechGroup Inc 370 West 1700 South Logan Utah 84321 8212 USA 800 453 2725 1 435 752 6011 WWW ELITECHGROUP COM...

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