Smiths Medical Pneupac babyPAC 100, User Manual

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504-2056A 6
Always connect the ventilator to the regulator before opening the cylinder valve and then
open the valve slowly in order to avoid the risk of ignition induced by the heat generated by
adiabatic compression.
3. Warning: Avoid smoking or naked flame.
4. Warning: Use in Aircraft (Section 2(a))
The use of oxygen and electrical systems aboard aircraft is regulated by the relevant aviation
authority because of the associated risks of fire, explosion and interference with aircraft
systems. Such use, therefore, must be authorised by the authority and the aircraft operator.
Particular control is exercised in the selection of devices handling high pressure oxygen such
as oxygen cylinders and their pressure reducing regulators.
5. Warning: Battery for MRI Use (Section 2(c)15)
In order to avoid any possible projectile risk causing damage or injury-
i) Use only battery supplied by Pneupac
®
and marked “For use in MR Compatible
ventilators”.
ii) Remove ventilator from MR environment before attempting to change battery.
iii) Do not take a loose battery into an MR environment.
6. Warning: Potential Unsatisfactory Performance with Alternative Ventilator Patient
Circuits (Section 2(c)18)
Circuits of alternative materials may be used but if these circuits have higher compliance
ventilatory performance may be compromised. Corrugated disposable hoses are not
recommended for this reason.
7. Warning: Provision of Accessories, Ancillaries and Spares for CE marked products
(Section 2(e), 6(d) & 7).
The babyPAC ventilators described in this manual carry a CE mark to certify that they have
been manufactured to conform to the requirements of the European Medical Devices
Directive 93/42/EEC. To ensure that this equipment is maintained to the requirements of the
Directive, only accessories, ancillaries and spares authorised by the manufacturer should be
fitted. All such parts sold by Pneupac
®
have /CE incorporated in their Order Code.
8. Warning: Pre-Use Checks (Section 4(b))
To avoid harm to the patient, pre-use checks must be performed before each use.
9. Warning: Functional Check (Section 3(b)13)
Any deviations observed in the above checking should be reported immediately to your
supplier, or an authorised service engineer, and the ventilator should not be used until a more
thorough check has been competed.
10. Warning: Release of Cylinder Pressure (Section 3(b)13)
Before changing gas cylinders, turn off the cylinder valve and then switch on the ventilator.
After one or two cycles the ventilator will stop and it is then safe to unclamp the pin index
yoke without a risk of injury or, in extreme cases, fire due to a sudden release of pressure.