14 - K4 b
2
User Manual
Important notices
Intended use
The measurement of oxygen uptake during sport or real life activities is of great interest
for the development of training programs and the study of their effects on elite athletes
or for assessing the efficacy of a rehabilitation therapy.
A common method for assessing the effects of endurance training is the monitoring of
various respiratory parameters during submaximal exercise.
One difficulty to achieve this goal during sport that cannot be simulated in the
laboratory is to use a reliable and valid portable system to measure VO
2
and VCO
2
in a
field setting.
Such a portable apparatus may also be useful to determine the energy cost of many sport
and real life activities.
K4 b
2
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 sale by or on the order of a physician.
This equipment has been conceived with the aim of providing an auxiliary instrument
allowing:
• the formulation of lung pathology diagnosis;
• important studies concerning human physiology;
• the collection of important information in sport medicine.
No responsibility attaches COSMED Srl for any accident happened after a wrong use of
the device, such as:
• use by non qualified people;
• non respect of the device intended use;
• non respect of the hereunder reported precautions and instructions.
Warnings
The device, the programme algorithms and the presentation of measured data have been
developed according to the specifications of ATS (American Thoracic Society) and
ERS (European Respiratory Society). Other international references have been followed
when these were not available. All bibliography references are reported in Appendix.
The present handbook has been developed with respect of the European Medical Device
Directive requirements which sort K4 b
2
within Class II a.
It is recommended to read carefully the following precautions before putting the device
into operation.
The precautions reported below are of fundamental importance to assure the safety of
all COSMED equipment users.
1. This user manual is to be considered as a part of the medical device and should
always be kept on hand.
2. Safety, measure accuracy and precision can be assured only:
• using the accessories described in the manual or given with the device. Actually
non recommended accessories can affect safety unfavourable. Before using non
recommended accessories it is necessary to get in touch with the manufacturer;
• ordinary equipment maintenance, inspections, disinfection and cleaning are
performed in the way and with the frequency described;
• any modification or fixing is carried out by qualified personnel;
• the environmental conditions and the electrical plants where the device operates
are in compliance with the specifications of the manual and the present regulations
concerning electrical plants. 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.
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