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Indications, Safety, and WarningsThe Digitrapper™ pH-Z system is an ambulatory monitoring system that allows for accurate and efficient measurement of pH and impedance.Indications for useThe Digitrapper™ pH-Z system is intended to record, store, view, and analyze esophageal and gastric pH data (and optionally, impedance levels) to diagnose reflux disorders.ContraindicationsThe use of the Digitrapper™ pH-Z system is contraindicated for the following:

Patients with an inability to tolerate nasal intubation

Patients with significant bleeding disorders for whom nasal intubation has been deemed contraindicated

Patients with a known esophageal obstruction preventing passage of the instrument

Adverse events or reactionsNasal passage insertionPotential adverse events associated with the use of this system and catheter insertion into the nasal passage may include:

Discomfort, nasal pain, minor bleeding, runny nose, throat discomfort, irregular heartbeat with dizziness, and perforation

In rare instances, catheter may be misdirected into the trachea causing coughing or choking, catheter may curl during intubation, and catheter position may move during the procedure

Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur. The system is not compatible for use in an MRI magnetic field.

Warnings and precautionsThe Digitrapper™ pH-Z system is intended to be used only by trained medical personnel in performing pH/impedance data acquisition. The quantitative estimates of physiological parameters acquired using the Digitrapper™ pH-Z system assists in the diagnostic process when uploaded into the analysis software, but clinical conclusions should not be made without proper medical training and consideration of the patient history.The Digitrapper™ recorder is classified as internally powered equipment, Type BF equipment (portable, with a patient-applied part, designed for continuous operation). The Digitrapper™ recorder is rated IP20 and as therefore not protected from the ingress of water. The recorder also provides floating patient isolation by making it physically impossible to connect both the patient and the USB port of a mains powered personal computer to the recorder simultaneously, under normal instructed use. For full specifications, see chapter 7 on technical data, page 22 of the instructions for use.Safety guidelines

Although the Digitrapper™ recorder is deemed to comply with EN 60601-1-2, there is no total guarantee that other equipment in the immediate vicinity of the recorder will not be affected by its electromagnetic emission. Similarly, other equipment may in turn affect the operation of the recorder. For more information, see the electromagnetic compatibility declaration (EN / IEC 60601-1-2), page 24 of the instructions for use.

Remove all connections from the recorder before changing batteries.

Never operate the device or touch the patient with the AA battery cover removed.

Remove AA batteries if the recorder will not be used for an extended duration. (An internal lithium cell battery retains the clock and other settings.)

Do not use any type of rechargeable batteries. Do not attempt to recharge AA or cell batteries.

Observe AA battery manufacturers’ instructions and dispose of batteries according to local regulations.

Do not use the recorder in the presence of a flammable anesthetic mixture with air or oxygen or nitrous oxide.

Use only reflux catheters provided by Medtronic. Use of non-approved catheters may degrade the EMC performance of the recorder.

Keep recorder in its cover when used by patients. The cover blocks access to I/O ports when patients are connected to an active catheter.

Patient benefits and risksBenefitsThe Digitrapper™ pH-Z system enables the detection of acid and non-acid reflux with pH and impedance sensors over a set time period. This provides richer, more accurate data for the physician.RisksRisks associated with Digitrapper™ pH-Z system are limited to the nasal intubation procedure. Potential complications include, but are not limited to, the following events:

Discomfort or pain (nasal and/or throat)

Minor bleeding, perforation, or hemorrhage

Aspiration

Fever or infection

Hypertension

Respiratory arrest

Cardiac arrhythmia or arrest

In rare instances, the catheter can be misdirected into the trachea, causing coughing or choking, or the catheter may shift up or down, causing false results.Caution: The Digitrapper™ pH-Z system is not compatible for use in an MRI.

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