Electrical Supply; Electromagnetic Compatibility - Air Liquide OSIRIS 3 Manual De Uso

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General safety instructions
Using oxygen
Safety instructions relative to oxygen must be respect-
ed:
• No smoking,
• No naked flames or incandescent objects,
• No greasy materials to be used.

Electrical supply

• Check that the mains supply to be used corresponds
exactly to the electrical characteristics of the equip-
ment.
• Before the initial use of the equipment and/or when
replacing the battery-pack, it is necessary to completely
charge the battery-pack (about 3 hours).
• This pulmonary ventilator must not be used with in-
flammable anaesthetic agents.
• This equipment conforms to protection requirements
of the 93/42/CEE directive.
• A new battery will only provide maximum perfor-
mance when it has been charged and discharged two
or three times!
Gas supplies to the equipment
• Supply the equipment from wall outlets or bottles at
a pressure in the range 280 kPa (2.8 bar) to 600 kPa (6
bar).
Starting up the equipment
• Each time the equipment is used check that the au-
dible and visible alarms are working correctly, and go
through the check list in the Appendix.
Use and maintenance of the equipment
Conforming to the standard EN 60601-1:
«The manufacturer, the assembler, the installer, or the
importer can only be considered responsible for safety
aspects, reliability, or the characteristics of the equip-
ment if:
• the assembly, additions, adjustments, modifications,
or repairs have been made by persons authorized by
him,
• the electrical installation where the equipment is used
conforms to CEI instructions,
• the equipment is used according to its instructions for
use».
If spare parts used by a technician for periodical mainte-
nance do not conform to manufacturing requirements,
the manufacturer is relieved of all responsibility in the
case of any incident.
• Do not open a unit which is connected to the mains
supply.
• This pulmonary ventilator must not be used with in-
flammable anaesthetic agents or explosive products..
• Do not use piping or tubing that is antistatic or that
conducts electricity.
• OSIRIS 3 must not be used on a patient without sur-
veillance.
• Do not use OSIRIS 3 in a hyperbaric chamber.
• For OSIRIS 3 to function correctly, keep the rear air in-
takes free of any obstacles, to allow free air circulation.
• In the event of operation in dangerous or explosive at-
mospheres, it is imperative that OSIRIS 3 is switched to
position VAC/ACMV 100% O2.
• The manufacturer has forseen most cases of possi-
ble malfunction and these are normally covered by the
integrated alarm system. However, it is recommended
that for totally dependent patients, back-up equipment
is closely available, such as a manual resuscitator.
• Efficient ventilation can be ensured by good settings
of the threshold for patients' breath detection (for rest-
less patients, etc.) as well as good surveillance of the
patient circuit.Using other equipment which does not
conform to the safety standards of OSIRIS 3 can cause
a reduction in safety levels. The factors to take into ac-
count when choosing other equipment are its use close
to the patient, conformity to the EN 794-3 standard and
recommendations contained in the accompanying doc-
umentation.
• Do not use OSIRIS 3 in a helicopter.
Non-invasive ventilation
• Perfect knowledge of OSIRIS  3 and of respiratory
physiopathology is necessary to ensure efficient mask
ventilation for the benefit of the patient.
Because of leaks (sometimes unavoidable) around a
mask, inhaled volumes may be appreciably different
from set volumes.
For certain types of use, it is recommended that
OSIRIS  3 be used with currently approved monitoring
equipment.

Electromagnetic compatibility

• This equipment conforms to the agreed standard
EN 60601-1-2 relative to electromagnetic compatibil-
ity of medical equipment and to special limitations of
EN 794-3 relative to emergency ventilators, but may be
affected by adjacent use of apparatus for diathermy,
high-frequency electro-surgery, defibrillators or short
wave therapy equipment, cellular telephones, or general
electromagnetic interference above levels fixed by the
EN 60601-1-2 and EN 794-3 standards.
• The OSIRIS 3 should not be placed next to or on top of
this equipment. If such use is necessary, the OSIRIS 3
should be observed together with the other ventilators
to ensure that they are operating normally.
• Do not use OSIRIS 3 in specifically magnetic environ-
ments (IRM, etc.).
• Any replacement of cables or internal parts, during
maintenance, which have not been provided by Air Liq-
uide Medical Systems, may cause an increase in equip-
ment emission or a decrease in its immunity.
Equipment cleaning and maintenance
• Do not use abrasive powders, alcohol, acetone, or oth-
er easily inflammable solvents.
YL033700 - Rev. 3a - 2019-02
General safety instructions - EN
3

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