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Essential safety information, intended use, and warnings for operating the K5 device.
Lists conditions where performing tests with the K5 device is not recommended.
Specifies the operating temperature, humidity, and pressure ranges for the K5 unit.
Guidance and declaration on electromagnetic compatibility for the K5 device.
Describes the structure and content of the K5 user manual.
Introduces the main parts and components of the K5 system.
Steps to take before installing the K5, including checking package contents.
Lists optional accessories available for the K5 system.
Lists available options, accessories, and spare parts for the K5.
Essential procedures like battery charging and unit preparation before use.
Step-by-step guide for installing or replacing the oxygen sensor.
Instructions for installing or replacing the rechargeable battery.
Procedures for preparing the patient, including mask and electrode placement.
How to establish communication between the K5 unit and a PC via USB or Bluetooth.
Contact information for COSMED for support and inquiries.
Explains the different configurations for using the K5: Holter, Telemetry, and Laboratory.
Overview of the K5's touch screen display and control keys.
Configuration options for international settings, system parameters, and IntelliMET.
Access to database management, control panel, and navigation features.
Procedures for calibrating the turbine, analyzers, and delay.
Guidelines for conducting exercise tests, including lab setup and patient prep.
Step-by-step guide for conducting tests in Holter, Telemetry, and Laboratory modes.
Process for transferring test data from the K5 unit to a PC.
Information on the integrated GPS functionality and its initialization.
General information on service operations and device care.
Detailed procedures for cleaning and disinfecting K5 components to prevent infection.
Guidelines for maintaining the sampling line to ensure measurement accuracy.
Procedures for inspecting the K5 equipment for safety and mechanical integrity.
Statement confirming the K5's compliance with relevant directives and standards.
Information on warranty coverage, limitations, and return policies.
Details on how personal data is collected, used, and protected.
Instructions for environmentally responsible disposal of the device.
Summary of safety standards, EMC compliance, and FCC regulations.
Specifications and technical details of the K5 unit and its components.
References for the calculation methods used in the K5 system.
List of cited literature and standards related to exercise testing.
| Category | Medical Equipment |
|---|---|
| Measurement Parameters | VO2, VCO2, VE, RER, HR, EE |
| Data Storage | Internal memory, SD card |
| Measurement Method | Breath-by-breath |
| CO2 Sensor | Infrared |
| Flowmeter | Turbine |
| GPS | Yes |
| HR Measurement Range | 30-240 bpm |
| Accuracy | ±2% |
| Power Supply | Rechargeable battery |
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