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Appendix H: Supplemental Information

Cystic Fibrosis: A Brief Description of the Disease

The Evolution of Sweat Test Methods

Development of the Nanoduct Neonatal Sweat Collection System

References

Appendix I: Pilocarpine Iontophoresis: Requirements and Risks

Burns Under Iontophoresis

Appendix J: Electromagnetic Compatibility (EMC)

Index

Содержание NANODUCT 1030

Страница 1: ...NANODUCT USER S MANUAL MODEL 1030 Neonatal Sweat Analysis System...

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Страница 3: ...NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM MODEL 1030 USER S MANUAL 57 0008 02A Last update 7 8 2020...

Страница 4: ...thout 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...

Страница 5: ...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...

Страница 6: ...he 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...

Страница 7: ...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 fiber pilocarpine reservoirs o...

Страница 8: ...formation about a topic Specific 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 in...

Страница 9: ...d 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 op...

Страница 10: ...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 den...

Страница 11: ...se 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 Medica...

Страница 12: ...12 12 Section 1 Introduction SYMBOL EXPLANATION Use By Temperature Limitation indicates high and low limits Warning Biological Hazard Harmful Irritant Environment Hazard Toxic...

Страница 13: ...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 ma...

Страница 14: ...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...

Страница 15: ...f 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 ch...

Страница 16: ...iontophoretic sweat stimulation 2 Measures electrical conductivity of the excreted sweat during the analysis phase 3 Automatically averages the conductivity reading over a defined 5 minute period 4 A...

Страница 17: ...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...

Страница 18: ...ever 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 co...

Страница 19: ...19 19 Section 1 Introduction Model Serial Number Identification Label The following label is located on the back of the instrument...

Страница 20: ...20 20 Section 1 Introduction User Interface Block Diagram...

Страница 21: ...or and insert the screws Using a Phillips screwdriver tighten the two screws that hold the door in place 4 Dispose of the spent batteries according to battery manufacturer s instructions and local reg...

Страница 22: ...ument in a demonstration mode 1 Make sure the Nanoduct is OFF While pressing and holding down the SELECT key press the ON key Keep the SELECT key pressed until the SETUP MENU displays on the screen Wh...

Страница 23: ...The display shows the Set 24 Hour Clock screen with the hour digits flashing Pressing the SELECT key increments the hours one hour at a time Pressing and keeping the SELECT key held down increments t...

Страница 24: ...nces to the y digit With the y digit flashing press SELECT to adjust the y digit Press ENTER to set the year The screen advances to the Set Month screen with the months digits flashing 3 While the mon...

Страница 25: ...o the Check Controls menu or the main menu on power up Select Force Cal to automatically go to the Check Controls on power up Select Cal Optional to calibrate only under user control and to automatica...

Страница 26: ...Test allows testing of current output conductivity and battery voltage 1 From the SETUP MENU select Self Test and press ENTER WARNING Do not run the Self Test while the module is connected to a patie...

Страница 27: ...value of the calibration point that the cable is connected to For example if connected to the 80 mmol L calibration point then the reading on the display should be 80 mmol L 5 Connect to the printer...

Страница 28: ...ay While running in this mode the ENTER key acts as a shortcut key and advances the instrument through the phases of the operation allowing the next display to be seen without waiting for the full ins...

Страница 29: ...MODE Suppress Readings Display Readings DEMO MODE 2019 04 15 12 05 Mean Electrolyte Concentration 27 mmol L eq NaCl Initial Sweat Rate 2 1 g m2 min Complete Iontophoresis DEMO MODE Full Current Sweat...

Страница 30: ...ed NOTE The operator should wear powder free gloves throughout the iontophoresis and sweat analysis processes graphics on the following pages do not show the operator with gloves on however gloves sho...

Страница 31: ...different lengths to fit infants older children and adults WARNING Watch for any signs of interference with blood circulation in the limb such as cyanosis swelling or unusual pallor and discontinue t...

Страница 32: ...t the gel fitted electrode into the holder B Lightly press the electrode down against the skin and maintain pressure while rotating the locking ring counter clockwise until the arrow indicator is in l...

Страница 33: ...UTION Do not disturb or remove the red holder It must remain in place during analysis In addition leave the negative black electrode gel holder and tape downs in position to provide a ground contact f...

Страница 34: ...2 inches from the strain relief Be sure to leave enough slack in the cable on the sensor side of the tape down to protect it from inadvertent tugging Make sure the tape down doesn t disturb the senso...

Страница 35: ...e second electrode The mean electrolyte concentration is displayed after another 5 minutes This value is compared with the established conductivity ranges for children under 16 years normal below 50 m...

Страница 36: ...the entire skin areas involved in the test D Wash and dry the electrode plates 16 Recall the Display Reading If you selected Suppress Readings or if the control unit powers off the last reading can b...

Страница 37: ...c range is therefore different from that established for chloride The electrolyte selected for calibration reference happens to be sodium chloride but it could have been any other salt The chemical na...

Страница 38: ...ith reference to these ranges for children under 16 years of age normal below 50 mmol L equivocal 50 to 80 mmol L and CF above 80 mmol L equivalent NaCl In non CF adults the normal range is frequently...

Страница 39: ...the diagnosis of cystic fibrosis ELITechGroup recommends that a physician be consulted before interpreting sweat test results if a sweat rate of at least 1 g m2 min is not achieved To provide the most...

Страница 40: ...not change from Please Wait Probable Causes No sweat detected possibly due to sensor cell not properly latched with locking ring or holder not adequately secured to patient Cable may have become deta...

Страница 41: ...ble Causes Low battery voltage Electrostatic discharge to the Nanoduct s face enclosure connectors or electrodes may cause the Nanoduct to reset see Appendix J Possible Solutions Replace all four batt...

Страница 42: ...essary Restart Lab Report software printer or computer and retransmit the data Reset the Nanoduct and retransmit the data Repeat the sweat test one time Data appears to be missing or corrupted when re...

Страница 43: ...persists contact ELITechGroup for further instructions Fault Calibration Not Completed Check Controls Probable Causes An attempt to calibrate to a value other than 80 mmol L Damaged electrode cable a...

Страница 44: ...c is under each electrode Clean electrodes if necessary Place a drop of deionized water directly on the clean skin beneath each Pilogel disc Ensure both electrodes are latched with locking ring and th...

Страница 45: ...to the Nanoduct Ensure holders are secured with adequate tightness to the patient s limb Do not overtighten and impede blood circulation Inspect the electrode cable assembly for any damage Do not use...

Страница 46: ...ode cable assembly Possible Solutions Black electrode must remain attached during sweat analysis for the Nanoduct to display a sweat rate value Connect red sensor connector to sensor cell immediately...

Страница 47: ...ries died during sweat analysis Process may have timed out due to patient producing very low sweat rate or insufficient sweat to fill sensor cell Possible Solutions Ensure sensor cell is latched with...

Страница 48: ...Replace electrode cable assembly Repeat the sweat test one time using a new sensor cell Reset the Nanoduct by doing the following 1 Remove the two Phillips screws from the battery door located on the...

Страница 49: ...ctrode surface CAUTION Never use harsh abrasives such as steel wool sandpaper or emery cloth to clean electrodes Never scrape electrodes with metal tools If the electrode surface is scratched or pitte...

Страница 50: ...NaCl Instructions 1 Select Check Controls on the menu and press ENTER Note that the date and time indications are in the format yy mm dd hh mm Dates times and other data shown are for example purpose...

Страница 51: ...e time of the calibration also gets displayed Data is sent to the serial port 8 Optionally for checking control values connect the sensor cell connector to any of the 3 control values 40 60 120 The va...

Страница 52: ...Connection 9 N C No Connection USB Device Type B Receptacle Electrical Four AA Alkaline batteries NEDA 15A IEC LR6 Typical solid state over current circuit protection 3 0 VDC lithium coin cell for th...

Страница 53: ...strument 4 0 lb 1 8 kg Sweat Analysis Conductivity Readout mmol L equivalent NaCl Conductivity Range 3 to 200 mmol L Error 1 or less from 25 to 150 mmol L equivalent NaCl Initial Sweat Rate Up to 50 g...

Страница 54: ...cement Parts RP 359 Electrode Cable Assembly RP 353 Strap Retainer Post RP 357 Positive Red Electrode and Sensor Cell Holder RP 358 Negative Black Electrode Holder RP 354 Holder Attachment Strap Small...

Страница 55: ...lues are sent to the printer Data from the Self Test mode includes the date time and the text Print Test Connecting to a Printer The serial port is configured as Data Communications Equipment DCE howe...

Страница 56: ...264 Wash hands forearms and face thoroughly after handling P270 Do not eat drink or smoke when using this product P301 P312 If swallowed Call a POISON CENTER a doctor if you feel unwell P330 Rinse mou...

Страница 57: ...lister like welts may also form Such blisters invariably disappear within 2 to 3 hours leaving no aftereffects But some patients may also experience skin burns in various degrees Minor skin burns have...

Страница 58: ...umbers SS 043 Supply Kit for Nanoduct with 32 0100 Pilogel Discs for Nanoduct Name and Business Address of Manufacturer ELITechGroup Inc 370 West 1700 South Logan Utah 84321 8212 USA Appendix E Piloge...

Страница 59: ...ctrode surface CAUTION Never use harsh abrasives such as steel wool sandpaper or emery cloth to clean electrodes Never scrape electrodes with metal tools If the electrode surface is scratched or pitte...

Страница 60: ...enance Authorization RMA number from ELITechGroup or an authorized service center 3 Enclose the instrument in a container comparable to its original packaging You may use the packaging from the loaner...

Страница 61: ...ather Investigations on the cause of the loss of sodium showed that the eccrine sweat of children with CF contains 3 to 4 times as much salt as that of unaffected subjects Subsequent work showed that...

Страница 62: ...n temperature throughout sweat collection condensation was prevented and the error disappeared In 1978 Wescor now ELITechGroup introduced the Model 3500 Webster Sweat Collection System that employed a...

Страница 63: ...or iontophoresis and collection that is scaled down to minimal dimensions enabling their effective application to extremely small limbs It is also evident that this approach taken alone would merely a...

Страница 64: ...ic fibrosis diagnosis by use of an improved sweat induction collection system and osmometry Clin Chem 27 385 1981 7 Barlow W K and Webster H L A simplified method of sweat collection for diagnosis of...

Страница 65: ...r Iontophoresis Minor skin burns have been an unwelcome adverse side effect of pilocarpine iontophoresis from the beginning of sweat testing with the Gibson and Cooke method Unusual sensitivity to pil...

Страница 66: ...ould assure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF Emissions CISPR 11 Group 1 The Nanoduct system uses RF energy only for its internal...

Страница 67: ...ulation 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 Modulation 217 Hz 1720 1845 1970 28 Pulse Modul...

Страница 68: ...MHz d m 1 2 P 80 MHz to 800 MHz d m 1 2 P 800 MHz to 2 7 GHz d m 2 3 P 01 Watts Maximum 1 m 1 m 2 m 1 Watts Maximum 4 m 4 m 7 m 5 W Maximum typical mobile phone 8 m 8 m 1 6 m mobile phone 1 Watts Maxi...

Страница 69: ...lt See Fault Condi tion Over Current Fault See Fault Con dition P Patient Simulator 50 Pilocarpine See Iontophoresis Pilocarpine Iontophoresis See Ionto phoresis Pilogel Iontophoretic Discs See Ion to...

Страница 70: ......

Страница 71: ...www elitechgroup com info elitechgroup com ELITechGroup Inc 370West 1700 South Logan Utah 84321 8212 800 435 2725 1 435 752 6011 REF 57 0008 02A...

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