alpHaONE™ – Capsule pH Monitoring System

For long-term measurement of oesophageal pH in patients with suspected gastroesophageal reflux disease (GERD)

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Product description

alpHaONE™ is a wireless capsule-based pH monitoring system for long-term measurement of oesophageal pH in patients with suspected gastroesophageal reflux disease (GERD). The system enables continuous pH recording for up to 96 hours, supporting well-founded diagnostic decision-making.

The system consists of a wireless pH capsule, a portable data recorder and alpHaLAB software for data analysis. The pH capsule is positioned on the oesophageal wall using a delivery catheter and fixed by vacuum suction and integrated fixation clips. The measured pH values are transmitted via radiofrequency to the recorder, where the data are stored.

Thanks to calibration-free technology with a dry reference electrode, time-consuming preconditioning with buffer solutions is no longer required, saving up to 20 minutes per examination. Capsule activation is performed at the push of a button, significantly simplifying preparation. No catheter remains in the oesophagus throughout the measurement period, greatly improving patient comfort and allowing monitoring under everyday conditions.

Indications

alpHaONE™ is intended for investigation of gastroesophageal reflux disease (GERD), including:

  • Patients with typical reflux symptoms such as heartburn or acid regurgitation
  • Patients with extra-oesophageal symptoms such as chronic pharyngitis, hoarseness, cough or asthma
  • Patients receiving PPI therapy for assessment of treatment efficacy

System Components at a Glance

The pH capsule is pre-mounted in the release mechanism of the delivery catheter and supplied together as a combined single-use set. The data recorder is available separately and intended for multiple use.

Delivery Catheter

  • For precise placement and fixation of the pH capsule
  • Release mechanism with soft tip for atraumatic placement
  • Vacuum suction, fixation clips, and capsule release conveniently operated via the handle
  • Catheter is completely removed after fixation

pH Capsule

  • Comprising a sensor, a nickel-free fixation clip and a signal acquisition module enclosed in a polymer coating
  • Measurement range pH 1–9
  • Effective operating time ≥ 96 hours
  • Wireless data transmission
  • pH measurement accuracy:
    • Degree of acidity: ± 0,5
    • Degree of alkalinity: ± 1

Data Recorder

  • Portable, battery-powered data recorder for direct patient use
  • Reception and storage of pH data
  • Compact, patient-friendly design with enlarged, easy-to-use buttons
  • Event buttons for documentation of symptoms and meals

alpHaLAB Software

The alpHaLAB software is used for the central preparation, analysis and documentation of reflux examinations.

  • Centralised patient management
  • Support for multiple examinations per patient
  • Automatic analysis and report generation
  • Calculation of SI, SSI and SAP
  • Automatic calculation of the DeMeester score
  • Export of customisable reports

Patient Comfort and Clinical Benefit

  • No transnasal probe during the measurement phase
  • Normal food intake possible during the examination
  • Monitoring under everyday conditions
  • Improved diagnostic value due to extended measurement duration

Product description

alpHaONE™ is a wireless capsule-based pH monitoring system for long-term measurement of oesophageal pH in patients with suspected gastroesophageal reflux disease (GERD). The system enables continuous pH recording for up to 96 hours, supporting well-founded diagnostic decision-making.

The system consists of a wireless pH capsule, a portable data recorder and alpHaLAB software for data analysis. The pH capsule is positioned on the oesophageal wall using a delivery catheter and fixed by vacuum suction and integrated fixation clips. The measured pH values are transmitted via radiofrequency to the recorder, where the data are stored.

Thanks to calibration-free technology with a dry reference electrode, time-consuming preconditioning with buffer solutions is no longer required, saving up to 20 minutes per examination. Capsule activation is performed at the push of a button, significantly simplifying preparation. No catheter remains in the oesophagus throughout the measurement period, greatly improving patient comfort and allowing monitoring under everyday conditions.

Indications

alpHaONE™ is intended for investigation of gastroesophageal reflux disease (GERD), including:

  • Patients with typical reflux symptoms such as heartburn or acid regurgitation
  • Patients with extra-oesophageal symptoms such as chronic pharyngitis, hoarseness, cough or asthma
  • Patients receiving PPI therapy for assessment of treatment efficacy

System Components at a Glance

The pH capsule is pre-mounted in the release mechanism of the delivery catheter and supplied together as a combined single-use set. The data recorder is available separately and intended for multiple use.

Delivery Catheter

  • For precise placement and fixation of the pH capsule
  • Release mechanism with soft tip for atraumatic placement
  • Vacuum suction, fixation clips, and capsule release conveniently operated via the handle
  • Catheter is completely removed after fixation

pH Capsule

  • Comprising a sensor, a nickel-free fixation clip and a signal acquisition module enclosed in a polymer coating
  • Measurement range pH 1–9
  • Effective operating time ≥ 96 hours
  • Wireless data transmission
  • pH measurement accuracy:
    • Degree of acidity: ± 0,5
    • Degree of alkalinity: ± 1

Data Recorder

  • Portable, battery-powered data recorder for direct patient use
  • Reception and storage of pH data
  • Compact, patient-friendly design with enlarged, easy-to-use buttons
  • Event buttons for documentation of symptoms and meals

alpHaLAB Software

The alpHaLAB software is used for the central preparation, analysis and documentation of reflux examinations.

  • Centralised patient management
  • Support for multiple examinations per patient
  • Automatic analysis and report generation
  • Calculation of SI, SSI and SAP
  • Automatic calculation of the DeMeester score
  • Export of customisable reports

Patient Comfort and Clinical Benefit

  • No transnasal probe during the measurement phase
  • Normal food intake possible during the examination
  • Monitoring under everyday conditions
  • Improved diagnostic value due to extended measurement duration

Selected products available directly from our warehouse in Zuchwil – we are happy to check additional variants for you
The versions listed below are, depending on the item, either available from stock or upon request.

Looking for a different size or variant? We will be happy to check further options and provide you with individual information on availability and delivery times.

Article number Product description Included in delivery per package Availability*
RC3107C alpHaONE pH-Capsule (JSPC-1) 1 piece ✅ In stock in Zuchwil
RC3100 alpHaONE pH-Capsule Monitoring System (JSPR-3) 1 piece ✅ In stock in Zuchwil

*Orders for in-stock items received by 4:00 p.m. (on business days) are dispatched the same day via A-Post.
Please note: on the day before a public holiday, we are happy to accept orders until 2:00 p.m.

Our consulting team is happy to help you.

Fabio Di Felice

Area Sales Manager for the region Central and South
Certified Medical Technology Consultant shqa

Cantons: BE, SO, TI

+41 79 270 78 51
fdifelice@admedics.com

Anne Rohrbasser

Area Sales Manager for the region West
Certified Medical Technology Consultant

Cantons: FR, GE, JU, NE, VD, VS

+41 79 527 17 63
arohrbasser@admedics.com

Robert Kowalski

Area Sales Manager for the region East
Certified Medical Technology Consultant shqa

Cantons: AI, AR, GL, GR, SG, SH, SZ, TG, UR, ZH, ZG, FL

+41 79 634 59 90
rkowalski@admedics.com

Gina Egli

Area Sales Manager for the region North-Central

Cantons: LU, NW, OW, AG, BL, BS

+41 79 738 60 37
gegli@admedics.com

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