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ESO 2 ICU Ventilator 2 User Manual
1. Warnings and Cautions
The following WARNINGS and CAUTIONS must be read and
understood before using this ventilator.
WARNINGS
Important
Delivering high fresh gas flows
1. High fresh gas flows when using closed endotracheal
suction. This ventilator is configured to deliver flows of
oxygen in excess of the maximum shown on the flowmeter
tube in order to fill the ventilator bellows during closed
endotracheal suction. Up to approximately 30 L/min can be
delivered.
Delivering O2 flows in excess of the maximum calibrated
flow will temporarily negate the possibility of accurate
volume delivery and measurement. Once the ventilator
bellows is full the O2 flow should be reduced to that in range
of the calibrated flow tube, then accurate volume delivery
and measurement will resume.
See section 5.3 for additional information.
General Information
2. Users must make themselves familiar with the contents
of this manual and the machine’s function before using
the ventilator.
Before Using the Ventilator
3. Before the ventilator is used clinically for the first time a
Calibration Check and Output Check must be successfully
completed. Checks must be carried out by a Penlon-
trained engineer.
4. Connect the ventilator to a mains supply with a protective
earth. Before first clinical use, verify that the hospital
engineering department has carried out an earth
continuity test. If the integrity of the protective conductor
is in doubt, do not use the ventilator.
5. Excessive electronic noise caused by other poorly
regulated devices, such as an electrocautery unit, may
adversely interfere the functioning of the ventilator.
Do not connect the ventilator’s power cord into the same
electrical outlet as an electrocautery unit.
6. If used with a mains extension cord, the unit may be
subject to electro-magnetic interference.
7. Portable RF communications equipment (including
peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12
inches) to any part of the ventilator, including cables
specified by the manufacturer. Otherwise, degradation of
the performance of this equipment could result.
8. The driving gas supply must be clean and dry to prevent
ventilator malfunction.
9. This ventilator is designed to be driven by medical air
only. The drive gas is set during manufacture and the
ventilator is calibrated for that gas.
Before the ventilator is used clinically for the first time,
the commissioning engineer must confirm that the air/
oxygen selection is set correctly to Air.
The use of any other gas will cause inaccurate operation
and may damage the ventilator, resulting in potential
injury to the patient.
10. The driving gas is discharged through the exhaust
valve port at the back of the ventilator control unit.
The discharged gas may contaminate the environment.
Connect to an AGSS system if available.
11. The bellows can only support approximately 1 kPa
(10 cmH2O) differential positive pressure, above which
it may be dislodged from the mounting ring, resulting in
dangerous malfunction of the ventilator. Do not connect
a positive end expiratory pressure (PEEP) valve or other
restrictive device to the exhaust port on the bellows base.
This would increase the pressure inside the bellows and
the bellows could detach from the base, causing serious
malfunction.
12. The data output, VGA, and printer ports must only be
connected to equipment complying with IEC safety
standards (e.g. IEC 60950) which are then configured to
comply with IEC 60601-1 (Medical Systems).
13. Breathing System
The breathing system which conveys gases from the
ventilator to the patient, and disposes of expired gases,
must conform to the requirements of ISO 80601-2-13.
Because breathing systems require frequent cleaning
and disinfection they are not a permanent part of the
ventilator and therefore cannot be directly under the
control of the manufacturer. However, we strongly
recommend that only breathing systems which have been
approved and authorised by the manufacturer for use
with the ventilator should be employed.
14. Do not use conductive breathing system hoses.
15. The spirometer sensors are mounted within the
absorber. Do not fit a spirometer sensor to any other
location. The device will not measure exhaled volumes in
any other position.
16. Verify the operation of each alarm function daily.
Periodically check the alarms at clinically suitable
intervals. If the audible alarm or the visual indicator
of any alarm function fails to activate during any alarm
condition or fails to reset after the alarm has been
cleared, refer the unit to an authorised service engineer.
17. Before using the ventilator check that all hose
connections are correct, and verify that there are no
leaks. Patient circuit disconnects are a hazard to the
patient. Extreme care should be taken to prevent such
occurrences.
Using the Ventilator
18. Do not use Spontaneous (SPONT) mode.
19. Before each clinical procedure, carry out pre-use
function checks on the ventilator (see section 4.2.1.3).
20. This apparatus must not be used with, or in close
proximity to, flammable anaesthetic agents.
There is a possible fire or explosion hazard.