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Dx–pH Measurement System™
Model Number XXXXX
Instructions for Use
Respiratory Technology Corporation
13670 Danielson St., Suite F
Poway, CA 9064
Ph (858) 679-300
Fax (858) 679-359

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  • Page 1 Dx–pH Measurement System™ Model Number XXXXX Instructions for Use Respiratory Technology Corporation 13670 Danielson St., Suite F Poway, CA 9064 Ph (858) 679-300 Fax (858) 679-359...
  • Page 2 Dx–pH Measurement System™ User’s Manual Version X.X August, 2005...
  • Page 3 The contents of this user’s manual are the property of Respiratory Technology Corporation. No part of this publication may be reproduced, stored in a retrieval system, be transmitted by any means – electronic, mechanical, photocopy, recording or otherwise be used in any form, by any means other than its intended purpose, without the prior written permission of Respiratory Technology Corporation.
  • Page 4: Table Of Contents

    Table of Contents Introduction Intended Use Symbols Recorder Event and Control Keys Event Marker Buttons Control Keys System Description Components Dx Recorder™ Dx–pH DataView™ Software Program Installing the Dx DataView Software Program Setup of a New Study Physician Setup Setup Calibrate the Probe Determining the Proper Catheter Placement Retrieving and Reviewing a Study...
  • Page 5: Intended Use

    Introduction The Restech Dx–pH Measurement System™ is a 24/48-hour, ambulatory, pH monitoring system consisting of a single use pH probe and reusable transmitter and recorder system. The Dx–pH Probe™ and Dx–Transmitter™ simultaneously measure pH and transmit the data to a recorder. The Dx–Recorder™ processes the data and saves the information to a removable secure digital data card.
  • Page 6: Symbols

    Symbols The following symbols are used on the Dx–pH Probe™ and/or in the accompanying documentation. SYMBOL MEANING Lot Number. Non-Sterile. Date of Manufacture. Each device is for one (1) use only. Expires. Attention. Read instructions prior to use.
  • Page 7: Event Marker Buttons

    Dx–Recorder™ Event Markers and Control Keys Event Marker Buttons Heartburn Button Cough Button Meals Button Supine/Sleep Button Control Keys Up Arrow Key Down Arrow Key Escape Key...
  • Page 8: System Description

    Dx–Transmitter™ NEED PICTURE Transmitter The Restech Dx–pH Measurement System™ contains a pH probe (Dx–pH Probe™) in a short, trans-nasal catheter that the patient wears for the duration of the study. The Dx–pH Probe™ measures pH and the transmitter sends the data to the Dx Recorder.
  • Page 9 Special Tool The “special tool” is provided by Restech to ensure proper handling of the transmitter when changing the coin cell battery. It is to be used to remove the cover on the...
  • Page 10 that this is used in removing the data card out of the back of the recorder. NEED PICTURE Batteries Two AA alkaline batteries are required to power the Dx– Recorder™. REPLACE PICTURE X Volt Lithium Coin Cell Batteries NEED PICTURE To Be Supplied by User: Computer REPLACE PICTURE...
  • Page 11 Dx–Recorder™ The Restech Dx–Recorder™ is an external unit that receives and stores data sent by the Dx–Transmitter™. Upon completion of a study, trained personnel will remove the data card from the recorder and insert it into a PC flash memory card reader. The Dx–...
  • Page 12: Dx-Ph Dataview™ Software Program

    To setup a new study, start the Dx–pH DataView™ program by double clicking the icon on your desktop or selecting it from the Start menu. Insert a formatted SD data card (supplied by Restech) into the card reader of your computer.
  • Page 13: Physician Setup

    The program will also ask you to confirm that all the information is correct, and if you are finished. Click YES or NO. After entering the patient data on the memory card, remove it from the card reader and insert it into the Dx–Recorder™ unit. Insert Picture of Side of recorder/Proper Insertion Physician Setup of the Dx–Recorder™...
  • Page 14: Calibrate The Probe

    After calibration in pH 7, you will be instructed to place the probe in the water, also supplied in the Restech Dx–Calibration Vials™ and then in pH 4. After calibration in pH 4, you will be instructed to rinse the probe with water.
  • Page 15: Retrieving And Reviewing A Study

    You will also be prompted to select either a 24 or 48 hour study. Use the Up / Down keys to select the appropriate time duration and then press any round key to accept Determine Proper Positioning of the Catheter Ask the patient which side of their nose is clearer and easier to breathe through.
  • Page 16: Download Ph Data

    Download pH Data Start the Dx–pH DataView™ program by clicking on the icon or selecting it from the start menu. After removing the data card from the side of the recorder, insert it into the provided card reader. If a window for the card automatically opens, simply close it and proceed with the following instructions.
  • Page 17: Changing The Ph Scale

    Viewing and Altering Graphs To view a graph of the patient’s study, select “Graph Data” from the “Graph” Menu while their information is on the screen. Changing the pH Scale The pH scale is set at a default of 0-10. To change this scale, select “Y” Scale Unlock from the ““Y”...
  • Page 18 Altering Graph Views 1. You may also enter the number of minutes to average and the percent drop below baseline. The program averages the values over the specified number of minutes (baseline) and detects drops of the specified percentage below baseline. 2.
  • Page 19 Enlarge a portion of the graph with respect to a chosen point. Reduce the size of the graph with respect to a chosen point. The button on the right to grab the graph at any point and drag it up, down, to the left or the right. 3.
  • Page 20 4. The horizontal scroll bar allows you to move the entire tracing itself along the X axis or to scroll along the pH tracing while viewing the pH values and time in the fields on the right hand side. To do the latter, the cursor must be engaged. 5.
  • Page 22 Before: After: If you think you may have made an error, or you would like to perform the edit again, click the button that says Undo Delete. After deleting the specified data sets, it will not be included in the analysis and will not be printed.
  • Page 23 You can right click on any point on the graph to display the following menu: An event marker appears on the lower graph as follows:...
  • Page 24 Changing the Style of Graphical Elements (Lower Graph) Placing your cursor over any of the three lines (Meal, Supine, or Symptoms) and right clicking your mouse will allow you to change the appearance of the lower graph. The following menu will “Fill Base Line”...
  • Page 25 Changing the Style of Graph Elements (Lower Graph - Continued) Choosing “Color” will allow you to change the color of each line. You must place the cursor over each line individually to “Line Width” allows you to adjust the change the colors. width of the graph lines “Bar Plots”...
  • Page 26: Viewing The Report And Diary

    Note: After altering the graph, be sure to recalculate the points in the “Report” menu and select “Save Graph” from the “Graphs” menu. Viewing the Report and Diary To view the report, select “View Report” from the Report menu. A warning will appear to remind you to recalculate the points if you have made changes to the graph or other data.
  • Page 27: Printing Graphs And Reports

    Symptom Index The symptom index correlations are performed by………… You may add notes that will be printed with the report as well in the field labeled “Notes:” When finished with the study, you may initialize the card for a new patient. You should do this as soon as you know the information for the next planned study.
  • Page 28 Click OK when the desired settings have been selected.
  • Page 29 Patient Operation of the Dx–pH Measurement System™ The Dx–pH Measurement System ™ was designed with patient convenience and ease of use as two of its foremost concerns. The patient is responsible for pressing event buttons, keeping a diary, and following the physician’s instructions. Before the patient is sent home, the following instructions must be emphasized along with the regular patient instructions (attachment B): •...
  • Page 30: Troubleshooting

    Troubleshooting Symptom Possible Cause Initial Start Up Status display indicates low AA Batteries are low. Replace AA Alkaline batteries. batteries. Calibration Status display indicates a Incorrect Calibration Fluids Press Esc and repeat failed calibration. or sequence used. calibration in proper sequence or try another probe Inoperable sensor.
  • Page 31: Cleaning

    Cleaning The exterior surface of the Dx–Recorder™ may be wiped down with a soft cloth lightly moistened with 70-90% isopropyl alcohol. The recorder should be turned off when cleaned. Care must be taken not to allow any liquid to pass into the front cover of the Recorder.
  • Page 32 Attachment A - Patient Instructions...
  • Page 33 Dx– Recorder™. This will ensure that the diary times entered in the Dx–DataView™ software are correct when the patient’s pH study is analyzed. Patient Diary Restech Dx–pH Measurement System™ Study Patient Code Investigation Date All Meals...

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