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Covers intended use, safety warnings, and contraindications for device operation.
Lists contraindications for spirometry, bronchial provocation, and exercise testing.
Specifies optimal environmental conditions (temperature, humidity, pressure) for device operation.
Provides a detailed overview of the Quark system's main unit, flowmeters, breathing valve, and masks.
Covers checking packing contents, optional modules, accessories, and system description.
Details front/rear panel layout, gas cylinder connection, and component assembly.
Guides on preparing the Quark unit and subject for exercise testing, including mask fitting.
Outlines general maintenance guidelines, emphasizing authorized personnel and device power-off.
Provides detailed procedures for infection control, component cleaning, and disinfection.
Lists disposable items and their replacement schedule for maintaining hygiene.
Provides guidance on electromagnetic emissions and immunity, and recommended separation distances.
States the manufacturer's declaration of compliance with medical device directives and standards.
Lists detailed technical specifications for flowmeters, analyzers, and accuracy.
Details warranty information, return policies, and COSMED contact details for support.
General| Type | Cardiopulmonary Exercise Testing (CPET) System |
|---|---|
| Category | Medical Equipment |
| Power Supply | 100-240 VAC, 50/60 Hz |
| Measurement Parameters | VO2, VCO2, VE, HR |
| Gas Analysis | O2, CO2 |
| Connectivity | USB, Ethernet |
| Sampling Rate | 100 Hz for gas and flow signals |
| Display | Integrated LCD |
| Dimensions | Varies depending on configuration |
| Weight | Varies depending on configuration |
| ECG | Optional, 12-lead ECG |
| SpO2 | Integrated SpO2 measurement |
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