AcuPebble® SA100

Product catalog summary

Introduction
AcuPebble SA100 is the first medical device to receive the CE mark for the automated diagnosis of Obstructive Sleep Apnoea (OSA). It has been clinically validated at the NHS Royal Free Hospital in London.

Key Features

Ease of Use: The device is simple to apply, requiring only the peeling off of an adhesive and placement on the skin.
Non-Invasive: Allows for natural sleep at home without the need for clinical visits.
No Training Required: Patients can use the device without prior training, reducing clinic visits and waiting times.
Accurate Diagnosis: Provides reliable automatic diagnosis, minimizing the need for test repetitions.

Cost-Effectiveness
The AcuPebble SA100 offers a cost-effective solution with validated diagnosis equivalent to the ambulatory gold-standard. It provides accurate AHI and ODI based diagnoses with high positive predictive value (PPV) and negative predictive value (NPV).

Patient-Friendly Design

Reduces patient burden by enabling remote testing, thus minimizing socio-economic impacts and contagion risks.
Features a compact sensor design with wireless data transfer capabilities.

Technical Specifications

Sensor dimensions: 2.9 cm diameter, 1.7 cm height, weight 7 grams.
Data transfer via mobile device and cloud for remote physician access.

Conclusion
The AcuPebble SA100 is a reliable, patient-friendly, and cost-effective solution for the diagnosis of Obstructive Sleep Apnoea, facilitating easy home testing with remote physician access.

Catalog excerpts

The ﬁrst medical device to obtain the CE mark for the automated diagnosis of Obstructive Sleep Apnoea Clinically validated diagnosis AcuPebble SA100 automated sleep apnoea diagnosis was validated in a powered clinical trial at the NHS Royal Free Hospital in London. Validated diagnosis equivalent to ambulatory gold-standard (multi-channel polygraphy followed by manual specialist interpretation). Validated AHI and ODI based diagnoses for both 3% and 4% desaturation criteria with high accuracy (94% PPV, 98% NPV). Patient-friendly design Cost-effective solution Easy to use: as simple as peeling oﬀ an adhesive and putting it on. Accurate automatic diagnosis: more tests with the same resources. Non-invasive: allows patients to have a more natural sleep at home. Simple and fast: no need to train patients; reduced waiting times. No training required: avoids unnecessary trips to the clinic. Reliable: reduces invalid tests that must be repeated. AcuPebble® SA100 product broch

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Easy home testing with remote physician access AcuPebble sensor 2.9 cm diameter 1.7 cm height Weight 7 gr Patient Fix to neck exterior using medical adhesive Wireless data transfer to nearby mobile device Data transfer and analysis (3G+ or Wi-ﬁ) Remote access to patient’s results via web app Reduce the burden for patients with remote testing The device can be sent to patients by post, avoiding unnecessary trips. Less time oﬀ work needed, reducing the associated socio-economic impact. No risk of contagion, as the sensor can either be disposed of or easily disinfected. Detailed sleep study report...

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