Cosmed Quark CPET, User Manual

Page: 11 / 102

Getting Started - Important Notices - 9
Measured Parameter Table

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. There is a bibliography of all references in the AppendixThis User Manual has been developed in accordance with the Class IIa European
Medical Device Directive requirements
Warning: To avoid risk of electric shocks, this device must be connected to sockets with protective earth
Read and understand these precautions before operating the device to ensure the safety of user and subject
1. This User Manual should always be available as a reference while testing
2. The following standards should be applied to ensure the accuracy of individual test results:
•
Accessories should only be used as they are described in this manual. The manufacturer does not warranty the use of any unauthorized
accessories. The manufacturer may offer suggestions while using third-party accessories and the complications which may occur
•
Device Service and Repair should ONLY be performed by COSMED authorized and trained personnel
•
Environmental and electrical conditions in which the device operates must comply with this manual. Note that the reliability of the device
ground and leakage current suppression is only assured when the three-wire power cord is connected to a grounding point (yellow-green
return connected to earth ground). Any attempt to avoid the proper groung connection is dangerous for both the user and equipment
•
Equipment maintenance, inspections, disinfection and cleaning should be as described in this manual.
3. Prior to powering on the system, the power cords and plugs should be fully inspected. Any damaged electrical part(s) must be replaced
immediately by COSMED authorized personnel.
4. Gas cylinders:
a. Large gas cylinders provided by the manufacturer or purchased by the customer must be secured with cylinder safety chains or
safety stands as required by local law
b. After removing the cylinder’s protective cap, the valve should be inspected for damaged threads, dirt, oil and/or grease. Any
dust or dirt should be removed; however, the cylinder should not be used if oil, grease, or damaged threads are present
c. Ensure that the pressure regulator is compatible with the intended gas cylinder (chemically and physically) prior to installation
d. The regulator must be properly connected and working pressure adjusted and displayed on the regulator
e. Close cylinder before disconnecting the cylinder from the
5. 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. Each component in contact with the subject’s breath should be cleaned and disinfected prior to each test
6. The cleaning procedures and inspections in the System Cleaning & Maintenance section should be performed prior to each test
7. 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)
8. The device should not come near any heat or flame sources, flammable or inflammable liquids or gases and explosive properties
9. The device should not be used in conjunction with any other medical device unless that device is recommended by the manufacturer
Parameter Description Parameter Description
FVC
Forced Expiratory Vital Capacity
P0.1
Respiratory Drive
FEV
1
Forced Expiratory Volume in 1 sec
V
E
Ventilation
FEF
25-75%
Mid-expiratory flow between 25-75% of the FVC
RF
Respiratory frequency
PEF
Peak Expiratory Flow
HR
Heart Rate
MVV Maximum Voluntary Ventilation VO
2
Oxygen uptake
FRC Functional Residual Capacity VCO
2
Carbon Dioxide production
DLCO CO Diffusion Capacity SpO
2
Hemoglobin saturation
MIP Maximum inspiratory pressure TGV Thoracic Gas Volume
MEP Maximum expiratory pressure