Cosmed Quark CPET, Руководство пользователя

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8 - Getting Started - Important Notices
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Important Notices

Intended Use
The COSMED Quark Series is a modular system with multiple configurations which can perform the following tests: Spirometry, Lung Function,
Cardiopulmonary Exercise, and Resting Metabolic Testing.
The system and its accessories are indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiologic parameters .
The main measurements which are displayed by this product line are Oxygen Uptake, Carbon Dioxide Production, Air Flow, Ventilation, Heart Rate
and Energy Expenditure. It is intended to assist a clinician in the diagnosis of cardiac and pulmonary diseases.
Caution: Federal law restricts the sale of this device by or on the order of a licensed healthcare practitioner to be sold to the order of a physician.
The Quark Series devices must not be used as monitoring device, nor as a sole means for determining a patient’s diagnosis, but for the purpose of
assisting the clinician in the cardiac and pulmonary cardio-pulmonary diseases.
This equipment is intended to be used for the following applications:
•
Understanding and Formulating lung pathology diagnosis
•
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:
•
Operation of the device by unqualified individuals
•
Use of the device not indicated by this manual
•
Not complying with the precautions and instructions described in this manual
Specific Indications for Use
Model Indication for Use Major Clinical Applications Measured Parameters
Quark
SPIRO
Pulmonary Function testing (Age 6 to adult) Spontaneously breathing
patients, healthy or individuals
affected by respiratory disease
(asthma or COPD, etc.) FVC, FEV
1
, FEF
25-75%
, PEF,
MVV, SpO
2
Quark PFT
Pulmonary Function testing
(Age 6 to adult)
Cardiopulmonary Exercise Testing (Age 6 to adult)
Spontaneously breathing
patients, healthy or individuals
affected by respiratory disease
(asthma or COPD, etc.) FVC, FEV
1
, FEF
25-75%
, PEF,
MVV, FRC, DLCO, MIP/MEP,
P0.1, SpO
2
, Ve, RF, HR, VO
2
,
VCO
2
, TGV
Quark CPET Pulmonary Function testing (Age 6 to adult)
Cardiopulmonary Exercise testing (Age 6 to adult)
Spontaneously breathing
patients, healthy or individuals
affected by diseases which limit
exercise tolerance FVC, FEV
1
, FEF
25-75%
, PEF,
MVV, VO
2
, VCO
2
, Ve, RF, HR,
SpO
2
Quark SPIRO and Quark PFT can also measure Airways Resistance Test using the interrupter technique (R
OCC
test) for pediatric patients (3 to 6 years
old). R
OCC
technique was specifically developed for pediatric population and uncooperative children unable to perform spirometric maneuvers (FVC,
SVC, etc.). The interrupter technique is possible to perform with preschool children, with repeatable results that correlate well with “gold
standard” techniques.