Cosmed microQuark, Руководство пользователя

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Important notices
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Intended use
MicroQuark is an electrical medical device designed to perform pulmonary function tests. It is to be used by physicians or by trained personnel on a
physician responsibility.
Caution: Federal law restricts this device to be sold by the order of a physician.
This equipment is intended to be used for the following applications:
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Formulating of a lung pathology diagnosis.
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Assisting with human physiology studies.
•
Contributing to sports medicine applications.
COSMED Srl is not responsible for incidents which occur due to improper use of this device. Examples include:
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Operation of the device by unqualified individuals.
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Use of the device not indicated by this manual.
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Not complying with the precautions and instructions described in this manual.

Warnings
The device, program algorithms and presentation of the measured data has been developed in accordance with the specifications outlined by the
ATS (American Thoracic Society) and ERS (European Respiratory Society). Additional international references have also been applied where
applicable. All bibliography references are reported in the Appendix.
This User Manual has been developed in accordance with the Class IIa European Medical Device Directive requirements.
The precautions listed below should be noted before operating the device to ensure the safety of the user.
1.
This User Manual should always be available as a reference when testing.
2. The following standards should be applied to ensure the accuracy of individual test results:
•
Accessories should only be used as described in this manual. The manufacturer does not warranty any non-authorized accessories used by
the end user. The manufacturer may offer suggestions while using such accessories and the complications they could cause;
•
Repairs or modifications of the device should ONLY be carried out by qualified and trained personnel;
•
Environmental and electrical conditions in which the device operates should be in compliance with the specifications of this manual. In
particular grounding reliability and leakage current suppression can only be assured when the device three-wire receptacle is connected
to a yellow-green return connected to earth ground. Attempting to defeat the proper connection of the ground wire is dangerous for
users and equipment.
•
Equipment maintenance, inspections, disinfection and cleaning should be as described in this manual.
3. Before powering on the system, the power cords and plugs should be inspected. Damaged electrical parts must be replaced immediately by
authorized personnel.
4. Residue and other contaminants in the breathing circuit pose a safety risk to the patient during testing procedures. Aspiration of contaminants
can be potentially life-threatening. If the recommended disposable anti-bacterial filters are not used, you must disinfect each part coming into
contact with the patient and patient’s breath prior to each test.
5. The cleaning procedures and inspections in the System Maintenance section should be performed prior to each test.
6. This device should not be used in the presence of flammable anaesthetics. This is not an AP or APG device (according to the EN 60 601-1
definitions).
7. The device should not come near any heat or flame sources, flammable or inflammable liquids or gases and explosive properties.
8. The device should not be used in conjunction with any other medical device unless that device is recommended by the manufacturer.
9. The device should be used with a computer with electromagnetic compatibility, CE marking and low radiation emission displays.
10. The PC connected to the device must be compliant with EN 60601-1 by means of an isolation transformer.
11. Precautions regarding EMC should be taken prior to installation and can be noted in the section EMC .
12. Portable and mobile RF communication equipment may interfere with the performance of the device.
6 - Getting started - Important notices