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Attachment A

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 Patient Instructions 

 
 
 

 

 

 

 

Summary of Contents for Dx-pH Measurement System

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: ...2 Dx pH Measurement System User s Manual Version X X August 2005...

Page 3: ...onditions are met 1 All repairs and modifications are carried out by Respiratory Technology Corporation or its assigned agents 2 Caution Changes or modifications not expressly approved by the party re...

Page 4: ...udy Physician Setup Setup Calibrate the Probe Determining the Proper Catheter Placement Retrieving and Reviewing a Study Download pH Data Opening a Past Study Graphs and Reports Changing the pH Scale...

Page 5: ...act with the receiver during the 24 48 hour pH study to record clinically relevant information such as meals and symptoms After completion of the pH study the pH data and patient information is downlo...

Page 6: ...ng 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 instr...

Page 7: ...7 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: ...be measures pH and the transmitter sends the data to the Dx Recorder Dx Recorder REPLACE PICTURE The Dx Recorder is a portable unit that receives pH data from the Dx pH Probe and Transmitter It saves...

Page 9: ...PICTURE The Dx pH DataView Software displays pH data that is stored on the Data Card by the Dx Recorder Dx Calibration Vials and Dx Calibration Stand REPLACE PICTURE The Dx pH Probe is calibrated with...

Page 10: ...by User Computer REPLACE PICTURE A PC with CD ROM Drive and Windows based operating system runs the Dx pH DataView Software program generates reports to be printed and stores patient data on the hard...

Page 11: ...ent 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 Recorder is designed to be li...

Page 12: ...o the card reader of your computer A window titled Removable Disk should appear close the window to continue In your Dx pH DataView program select New Patient from the File menu Enter the last name fi...

Page 13: ...placement Setup Setup allows you to adjust the system time select the study duration and set user interface options You will be prompted to either accept or change time and date information If the tim...

Page 14: ...Vials which are pre filled with pH buffer solution Select Cal from the main menu The recorder will display the Transmitter ID number that was used You will be prompted to accept this ID Pressing the u...

Page 15: ...te Have the patient swallow sips of water to see if they can feel the probe in their throat if they can pull it back slightly until it is comfortable for the patient After the proper position has been...

Page 16: ...for the card automatically opens simply close it and proceed with the following instructions In the File menu of the Dx pH DataView program select the option to Retrieve Completed Study Opening a Pas...

Page 17: ...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 Scale Menu Now you can enter the desired values for the study in review Whe...

Page 18: ...n the top right corner of the screen perform various functions to allow this manipulation a The button on the left allows you to move the cursors along the X axis When the cursor rests on a point it w...

Page 19: ...o the left or the right 3 The button is for scrolling in fine increments to view pH changes with precision along the X or Y axis Note that to use it along the Y axis the Y Scale must be unlocked The t...

Page 20: ...ts The button in the center allows you to change the color and style of the cursor the point style the line style and width display the name of the cursor bring it to the center of the page and go to...

Page 21: ...21...

Page 22: ...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 To replace this data...

Page 23: ...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: ...ny 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 appear Fill Base Line will Selecting Comm...

Page 25: ...e Width allows you to adjust the width of the graph lines Bar Plots The Interpolation function allows you to connect the points using various methods of interpolation illustrated in the six different...

Page 26: ...ng doctor The patient name first and last and study date are required fields in specific formats The user defined events are displayed and if none were entered the words Event 1 Event 2 and Event 3 wi...

Page 27: ...vious information will be removed from that card make sure the patient data has been saved Printing Graphs and Reports Selecting Print Graph from the Printing Menu prints the graph with no preview If...

Page 28: ...28 Click OK when the desired settings have been selected...

Page 29: ...ons attachment B How to keep a written diary For analysis information about episodes of pain and episodes of cough supine periods and meal periods is needed and is very important See attachment B How...

Page 30: ...r evaluation Recorder will not accept the data card Data is still saved from previous study Download data into Dx ph DataView and reinitialize card Start pH Study Transmitter identified does not match...

Page 31: ...he front cover of the Recorder Let the surfaces evaporate thoroughly before use Service The Dx Recorder does not require routine calibration or servicing of internal components unless the recorder bec...

Page 32: ...32 Attachment A Patient Instructions...

Page 33: ...r meals and sleep periods using the time from the clock displayed on the Dx Recorder This will ensure that the diary times entered in the Dx DataView software are correct when the patient s pH study i...

Page 34: ...34...

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