Restech Dx-pH Measurement System Bedienungsanleitung
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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Dx–pH Measurement System™
User’s Manual
Version X.X
August, 2005
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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.
This publication is supplied for the purpose of using the Dx–pH Measurement System™
only. Respiratory Technology Corporation is responsible for the reliability and
performance of the Dx–pH Measurement System™ only if the following conditions 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 responsible
for compliance could void the user's authority to operate the equipment.
3. This device complies with part 15 of the FCC Rules. Operation is subject to the
following two conditions: (1) This device may not cause harmful interference, and,
(2) This device must accept any interference received including interference that
may cause undesired operation.
4. The transmitter’s end location will have a label on the outside compartment stating:
“Contains FCC ID: TLUDX-SYSTEM”
CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a
physician.
Contraindications: Deviated Septum, nasal congestion or infection.
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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
Download pH Data
Opening a Past Study
Graphs and Reports
Changing the pH Scale
Altering the Graphs
Viewing the Report and Diary
Printing Graphs and Reports
Printing Graphs and Reports
Patient Operation of the Dx–pH Recorder™
Troubleshooting
Cleaning
Service
Attachment A
Patient Instructions for Use
Attachment B
Example Patient Diary
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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. The patient is able to interact 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
downloaded from the data card to a PC using a card reader. The data and information can
be viewed using a Windows based software program.
The Dx–pH Probe™ is provided non-sterile to the end user. It is disposable, with a usable
life of one procedure. All other components are reusable.
Intended Use
The Restech Dx–pH Measurement System™ is intended to measure and monitor
supraesophageal pH changes due to gastric reflux.
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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.
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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
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System Description
Components
The Dx–pH Measurement System™ includes the following:
Probe
Dx–pH Probe™
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.
Dx–Recorder™
REPLACE PICTURE
The Dx–Recorder™ is a portable unit that receives pH data
from the Dx–pH Probe™ and Transmitter. It saves this
information to a removable data card. The patient is able to
interact with the recorder during the pH study to record
clinically relevant information and symptoms.
Data Card
REPLACE PICTURE
The Data Card is inserted into the Dx–Recorder™ after the
physician enters the appropriate patient information on it.
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After the study, the physician removes the card from the Dx–
Recorder™ and inserts it into a Data Card Reader to review
the pH Study using the Dx–pH Data View™ Software on a
personal computer.
PC Flash Memory Card Reader
REPLACE PICTURE
Interfaces with the computer to download the data from the
SD data card for display in the Dx–pH DataView™ software.
Dx–pH DataView™ Software
(CD Rom) REPLACE 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 pH 4 and pH 7
standard buffer solutions prior to use in a study. Water is
also included in the calibration kit to rinse the probe between
calibrations.
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
transmitter to allow battery access. It is also recommended
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that this is used in removing the data card out of the back of
therecorder.
NEED PICTURE
Batteries
Two AA alkaline batteries are required to power the Dx–
Recorder™.
REPLACEPICTURE
X Volt Lithium Coin Cell Batteries
NEEDPICTURE
To Be Supplied 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 drive.
(Recommended system requirements: 600 MHz Pentium III, Celeron
or equivalent processor. Recommended disk space of 155 MB and18
MB RAM.)
Printer
REPLACE PICTURE(Windows compatible) prints patients’ pH reports for review by the
prescribing physician.
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