Indications and Safety Warnings

Intended Use

The Restech Dx–pH Measurement System is intended for gastroesophageal pH measurement and monitoring of gastric reflux. The pH data Recorder and data viewing program are intended for gastroesophageal pH data acquisition and analysis to diagnose reflux disorders.

Use of the Dx-pH Measurement System and DataView v4 Software

The Dx-pH Measurement is intended for healthcare professionals trained in performing clinical procedures. Restech offers on-site training and Internet based training prior to use of the product. Refer to the Restech contact information in Sections 17 and 18 for Service and Technical Support. Users must be familiar with the labeling and Instructions for Use associated with the equipment. The user of the device is advised to fully understand the use of the equipment and be familiar with the location and function of the controls and alarms prior to use.

This Instructions for Use is designed to be used with the DataView v4 User Guide provided with the DataView v4 software. Both the Instructions for Use and the User Guide assume the user has the basic computer skills common to Microsoft software applications including: use of Windows® Explorer to browse and manage files and folders; ability to open and launch applications; use of mouse click and mouse double-click controls; use of dialog boxes and message boxes; use of menu bars to execute menu commands; and ability to minimize, maximize, resize, and move application windows.

Contraindications

Deviated septum, nasal congestion or infection.

Disclaimer

The information in this manual is subject to change without notice. Restech makes no representations or warranties with respect to its contents, and specifically disclaims any implied warranties of merchantability or fitness for a particular purpose. Restech reserves the right to revise this publication and to make changes to it from time to time.

General Warnings and Precautions

  • Federal Law (USA) restricts this device to sale by or on the order of a licensed physician or properly licensed practitioner.
  • Read Instructions for Use (IFU) prior to use.
  • Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.
  • See Warranty information for contact information and eligibility requirements.
  • Potential complications associated with nasal intubation include, but are not limited to: sore throat, trauma to nasopharynx, or bloody nose.
  • Use only Restech Dx–pH Measurement System components and accessories.
  • Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL EQUIPMENT.
  • Do not shower or bathe with the Dx–pH Measurement System. Do not get the Recorder and Transmitter wet or expose them to excessive moisture; they are not waterproof. Doing so may damage the equipment as well as provide incorrect or inaccurate data.
  • Keep the Recorder within 15 feet of the Transmitter to avoid loss of data.
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