tremoflo C-100 Technical Specifications

Product catalog summary

Overview
The THORASYS tremoFlo C-100 Airwave Oscillometry System (AOS) is a portable device for measuring pulmonary function in patients without requiring effort. It offers non-invasive, easy-to-use measurements that can detect lung diseases early and provide insights into disease mechanisms.

Principle of Operation
The device uses oscillometry, specifically the Forced Oscillation Technique, with patented vibrating mesh technology. It operates within a frequency range of DC to 37 Hz and connects to patients via a disposable mouthpiece and filter. Measurements typically last 16 to 30 seconds and require no patient maneuvers.

Measurements
Raw Data: Measures flow, volume, and mouth pressure with high accuracy and resolution. Calibration is quick, typically under one minute.
Oscillation Waveforms: Offers various waveforms for adults and pediatric patients, including non-harmonic and harmonic signals.
Impedance Data: Provides resistance and reactance data, indicating airway conditions and lung compliance.

Outcome Parameters
Includes resistance and reactance at various frequencies, tidal volume, and respiratory rate. These parameters help assess overall respiratory system resistance and small airway obstructions.

Normative Data
References studies providing demographic-specific parameters for adults and children, predominantly from Caucasian cohorts.

Physical Device
Ratings & Connectivity: Operates with a 24V power supply and connects via Ethernet. Emits noise levels below 60 dB(A).
Dimensions & Weight: Compact and lightweight, with the handheld device weighing 0.7 kg.

Certifications & Regulatory
Certified as a Class II medical device in Canada, Europe, and Australia, with pending FDA approval in the US. Meets ERS guidelines.

Computer System Requirements
Compatible with Windows 7/8/8.1 systems, requiring a dual-core CPU, 3 GB RAM, and specific connectivity options.

Data Storage
Stores data in a relational database, with encryption for patient data. Logs user actions and exceptions for support purposes.

Catalog excerpts

tremoflo C-100 Technical Specifications-1

THORASYS Thoracic Medical Systems Inc. Doc-No. MKT-102264, Rev. 2.2, 26-Jan-15 tremoFlo® C-100 Technical Specifications (English) 1 Overview The THORASYS® tremoFlo® C-100 Airwave Oscillometry System™ (AOS) is a handheld, portable medical device to measure pulmonary function without patient effort in quietly breathing patients. Compared to traditional lung function measurements, the tremoFlo uniquely combines of non-invasiveness, ease of use and new outcomes that potentially provide earlier detection of lung disease and exacerbations, and better insight into disease mechanisms and small airway disease. This document applies to Part Numbers 101336 and 101490 used in combination with tremoFlo Software Version 1.0. The tremoFlo is protected by US and international patents. Disclaimer: The content of this document is believed to correct at the time of release. However, THORASYS and its affiliates offer no guarantees whatsoever, express or implied, in case of typographic or other errors. All specifications are subject to change without notice. THORASYS Thoracic Medical Systems Inc. 6560 avenue de l’Esplanade, Suite 103 Montreal, Quebec H2V 4L5, Canada www.thorasys.com | [email protected] +1-514-384-8555 | Skype: THORASYS Page 1

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tremoflo C-100 Technical Specifications-2

THORASYS Thoracic Medical Systems Inc. Doc-No. MKT-102264, Rev. 2.2, 26-Jan-15 1 Mouth pressure swings depend on patient and oscillation waveform used. THORASYS Thoracic Medical Systems Inc. 6560 avenue de I'Esplanade, Suite 103 Montreal, Quebec H2V 4L5, Canada www.thorasys.com | [email protected] +1-514-384-8555 | Skype: THORASYS Page 2 of 7

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tremoflo C-100 Technical Specifications-3

THORASYS Thoracic Medical Systems Inc. Doc-No. MKT-102264, Rev. 2.2, 26-Jan-15 Nominal Impedance Range: 0.5 to 15 cmH2O.s/L Nominal Impedance Accuracy: 10% or 0.1 cmH2O.s/L, whichever is greater 2 Pediatric waveforms in preparation THORASYS Thoracic Medical Systems Inc. 6560 avenue de I'Esplanade, Suite 103 Montreal, Quebec H2V 4L5, Canada www.thorasys.com | [email protected] +1-514-384-8555 | Skype: THORASYS Page 3 of 7

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tremoflo C-100 Technical Specifications-4

THORASYS Thoracic Medical Systems Inc. Doc-No. MKT-102264, Rev. 2.2, 26-Jan-15 Note: The above table lists the most commonly reported outcome parameters. Further outcome parameters such as the resistance and reactance values at other measurement frequencies are also available for display and reporting. Contact THORASYS or your closest representative for details. THORASYS Thoracic Medical Systems Inc. 6560 avenue de I'Esplanade, Suite 103 Montreal, Quebec H2V 4L5, Canada www.thorasys.com | [email protected] +1-514-384-8555 | Skype: THORASYS Page 4 of 7

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tremoflo C-100 Technical Specifications-5

THORASYS Thoracic Medical Systems Inc. Doc-No. MKT-102264, Rev. 2.2, 26-Jan-15 THORASYS Thoracic Medical Systems Inc. 6560 avenue de I'Esplanade, Suite 103 Montreal, Quebec H2V 4L5, Canada www.thorasys.com | [email protected] +1-514-384-8555 | Skype: THORASYS Page 5 of 7

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tremoflo C-100 Technical Specifications-6

THORASYS Thoracic Medical Systems Inc. Doc-No. MKT-102264, Rev. 2.2, 26-Jan-15 Dimensions - WxDxH THORASYS Thoracic Medical Systems Inc. 6560 avenue de I'Esplanade, Suite 103 Montreal, Quebec H2V 4L5, Canada www.thorasys.com | [email protected] +1-514-384-8555 | Skype: THORASYS Page 6 of 7

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