ReOxy® · Intermittent Hypoxic–Hyperoxic Treatment (IHHT®)

The medical device that makes the dose personal.

Individual physiological dosing, integrated monitoring and dedicated safety control — developed into one medical device by AiMediq.

Intended use: improvement of physical exercise capacity in adult and senior patients with coronary artery disease (CAD).

For use in a clinical environment under professional supervision and according to a doctor's prescription.

01

Clinical workflow

Assess, guide, document

  1. 01 · ASSESS

    Hypoxic Test

    The Hypoxic Test characterises the individual oxygen-saturation and pulse response before treatment. The supervising physician confirms the treatment parameters.

  2. 02 · GUIDE

    SRT® Technology

    SRT® Technology uses the measured physiological response to guide hypoxic exposure and hyperoxic recovery throughout the treatment.

  3. 03 · DOCUMENT

    Reports and records

    Automatic test and treatment reports and session traceability for clinical workflows; storage for up to 1,000 patients and 100,000 reports.

How dosing works: the method in detail

02

Measurement and safety

What ReOxy® measures

ICU/CCU-grade monitoring

ReOxy® implements ICU/CCU-grade SpO₂ monitoring integrated into the measurement and control architecture.

Gold standard Masimo SET® pulse oximetry

ReOxy continuously measures SpO₂ and pulse rate using Masimo SET® pulse oximetry and displays perfusion index. The supplied-gas flow trace represents breathing pattern.

  • SpO₂
  • Pulse rate
  • Perfusion index
  • Breathing pattern

Layered safety

Layered safety concept:

  • treatment requires valid signal readings;
  • defined response boundaries trigger protective action;
  • continuous system supervision provides clear status messages and prioritised alerts.

For use in a clinical environment under professional supervision and according to a doctor's prescription.

See the Instructions for Use for contraindications, warnings and precautions.

Three processors.
Hardware-separated functions.

Three-level, three-processor architecture with redundant hardware-separated measurement, multi-valve-dosing (instant-mixing technology) and safety control.

SRT® treatment control

A dedicated embedded controller runs SRT® based on 10 different internal sensor measurements.

Purpose-designed for ReOxy®

More than 90% of components have been specifically designed for the ReOxy® medical device.

03

Engineering and manufacturing

Engineering, manufacturing and quality

  1. 01

    Medical-device engineering

    AiMediq's dosing principle became ReOxy® through medical-device engineering with Bitmos — respiratory technology, patient monitoring and medical software. Gas-system performance and quality are checked in a dedicated test facility, separate from assembly.

  2. 02

    Manufacturing and quality system

    Manufactured in Germany: ReOxy® is serially manufactured by Bitmos GmbH, Düsseldorf. Bitmos' quality management system is certified to EN ISO 13485:2016 by TÜV Rheinland (SX 1010072-1).

Quality at AiMediq

The ReOxy® device: a white mobile unit with a touchscreen on top and a breathing mask attached to the front.
ReOxy® with breathing mask
04

For procurement and technical review

Technical data and documents

What a clinic needs to assess the device: technical data, the Instructions for Use and the device information pack.

Technical data

ReOxy 60-2001: 230 V~, 50 Hz; maximum power consumption 550 W; weight 44 kg; dimensions 90×70×50 cm (H × D × W, on wheels, monitor collapsed); noise level 55 dB(A). The device generates hypoxic and hyperoxic gas mixtures from ambient air.

Provide 230 V~, 50 Hz power and at least 30 cm clearance from walls, curtains and large objects for air intake. Keep the air-cooled device away from heaters and do not stack it with other equipment. IFU operating range: +5 to +40°C; 15–95% relative humidity, non-condensing; altitude below 1000 m. Plan space for the chair, patient access and clinical supervision with the site team.

Instructions for Use

Available to healthcare professionals after login.

Instructions for Use (HCP)
Device information pack

Device overview, technical data sheet, service and training, and the quality documents a procurement file needs.

Request the device information pack

The clinical and procurement pack includes product information, intended use, the clinical evidence overview, applicable conformity and quality documents, IFU, technical data, installation, training and service information. Request the clinical and procurement pack.

Service and training

Installation, user training, maintenance and service contacts.

Maintenance-free operation.

No scheduled replacement of the device’s internal components is required throughout its service life.

Each patient uses their own individual breathing set — mask, tubing and filter — throughout their course of treatment.

The dust filter is accessible through a dedicated compartment. Routine checks, filter replacement and annual safety inspection follow the Instructions for Use.

Discuss installation, staff training, routine service and patient accessories with our team.

Installation, operator training and service arrangements are agreed for the supply country and clinic. The implementation plan identifies the responsible provider and support route.

Quotation

For clinics and healthcare institutions: request a quotation for your country. Please tell us how many devices you need and your planned timeline.

Availability varies by country.

Request a quotation

05

Intended use

Intended use: improvement of physical exercise capacity in adult and senior patients with coronary artery disease (CAD).

For use in a clinical environment under professional supervision and according to a doctor's prescription.

See the Instructions for Use for contraindications, warnings and precautions.

Availability varies by country.

Contraindications, warnings and precautions

Listed in the Instructions for Use for healthcare professionals.

Contraindications and safety information

Source: ReOxy Instructions for Use TD075530 Rev.9, §§3.3.2–3.3.3. The physician must review the full instructions and the patient’s current condition before treatment.

  • Acute cerebrovascular events within the previous six months
  • Acute forms of ischaemic heart disease, including acute coronary syndrome and myocardial infarction
  • Heart failure NYHA class III–IV
  • Chronic obstructive pulmonary disease or bronchial asthma with significant respiratory distress (SpO₂ below 90%)
  • Renal failure
  • Oncological diseases
  • Systemic diseases
  • Severe psychiatric diseases
  • Individual intolerance to oxygen deficiency
  • Severe systemic non-cardiac disease
  • Acute inflammatory diseases
  • Acute somatic diseases
  • Congenital or acquired defects of the heart and major vessels
  • Severe chronic obstructive pulmonary disease

Patients with silent myocardial ischaemia require ECG monitoring during testing and treatment. Report chest discomfort, headache, dizziness, sleepiness or feeling unwell to the supervising clinical staff. These are possible reactions listed in the IFU; the list does not replace its complete warnings and precautions.

Instructions for Use (HCP)

For patients and families

What happens in a session and questions to ask your doctor.

Information for patients and families