Cosmed Quark PFT, Manual

Page: 12 / 148

12 - Quark PFT User Manual
Important notices
Intended use
Quark PFT 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 program 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 Quark PFT 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.
3. Before powering the system, check the power cables and the plugs. Damaged
electrical parts must be replaced immediately by authorised personnel.
4. Large gas cylinders, which may be given by the manufacturer or purchased by the
customer, should be secured with cylinder safety chains or safety stands.
5. When removing the protective cap, inspect the cylinder valve for damaged threads,
dirt, oil or grease. Remove any dust or dirt with a clean cloth. If oil or grease is
present on the valve of a cylinder which contains oxygen, do not attempt to use.
Such combustible substances in contact with oxygen are explosive.
6. Be certain that the materials of the pressure regulators are chemically compatible
with the intended gas service before installation. Inspect the regulator for the proper