Cosmed Q-NRG, Руководство пользователя, Страница: 15 / 152

13/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2
Chapter 1 - Get Started COSMED srl
21. Do not place the device in any position that might cause it to fall on the patient.
22. This device shall be installed in an indoor environment on a flat hard surface (do not place it on the floor) or
by means of an adequate standard VESA clamp; make sure that the surface is dry and clean from any dust.
23. As with all medical device, carefully route the ventilator circuit, patient cabling, and external power cables
to reduce the possibility of patient entanglement or strangulation.
24. Mechanical shocks or drops (e.g. as a result for a free fall or bang on hard surfaces) may have adverse
effects on measurements accuracy. Whether the device is visibly externally damaged or not, DO NOT use it
and immediately return it to COSMED or to an authorized service center for a technical service.
25. Any serious incident that occurs in relation to the device should be reported to the manufacturer and the
competent authority of the Member State in which user and/or patient is established.
26. Do not use Q-NRG/Q-NRG+ components for a cumulative period greater than 24 hours. Normal use of the
device is for a limited number of uses on the same patient over a limited timeframe, due to the limited
daily-weekly-monthly variation of resting energy expenditure (REE), as indicated in ‘Best Practice Methods
to Apply to Measurement of Resting Metabolic Rate in Adults: A Systematic Review: J Am Diet Assoc. 2006;
106:881-903’. Typical maximum usage is for 60 minutes three or four times in two weeks.
Note: The device, program algorithms and data presentation have been developed in accordance with the
recommendations outlined in current scientific guidelines and literature, the bibliography of references
is reported in the Appendix.
This user manual has been developed in accordance with European Medical Device Directive and US 21 CFR 820
requirements.
Security Information
Protecting Personal Information
Protecting personal health information is a primary component of a security strategy. Each facility using the device
must provide the protective means necessary to safeguard personal information consistent with country laws and
regulations, and consistent with the facility’s policies for managing this information.
Protection can only be realized if you implement a comprehensive, multi-layered strategy (including policies,
processes, and technologies) to protect information and systems from external and internal threats.
As per its intended use, the device operates in the patient vicinity and contains personal and sensitive patient data.
To ensure the patients’ safety and protect their personal health information you need a security concept that
includes:
• Physical security access measures - access to the device must be limited to authorized users. It is essential
that you consider physical security measures to ensure that unauthorized users cannot gain access.
• Operational security measures - for example, ensuring that patients data are deleted after completing the
measurement.
• Procedural security measures - for example, assigning only staff with a specific role the right to use the
device.
In addition, any security concept must consider the requirements of local country laws and regulations.