General Safety Instructions - Air Liquide OSIRIS 2 Manual De Uso

GENERAL SAFETY INSTRUCTIONS

USING OXYGEN
Safety instructions relative to oxygen must be respected:
• 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 equipment.
• Before the initial use of the equipment and/or when
replacing the battery-pack, it is necessary to completely
charge the battery-pack (about 10 hours).
• This pulmonary ventilator must not be used with
inflammable anaesthetic agents.
• This equipment conforms to the agreed standard EN
60601-1-2 relative to electromagnetic compatibility 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 60 601-1-2 and EN 794-3 standards.
• Do not use OSIRIS 2 in specifically magnetic
environments (IRM, etc.).
• This equipment conforms to protection requirements of
the 93/42/CEE directive.
• A new battery will only provide maximum performance
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 audible
and visible alarms are working correctly, and go through
the check list in the Appendix (page 19).
Use and maintenance of the equipment
Conforming to the standard EN 60 601-1 (Appendix A §
6.8.2.b):
«The manufacturer, the assembler, the installer, or the
importer can only be considered responsible for safety
aspects, reliability, or the characteristics of the equipment 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 maintenance
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
inflammable anaesthetic agents or explosive products..
• Do not use piping or tubing that is antistatic or that
conducts electricity.
• OSIRIS 2 must not be used on a patient without
surveillance.
• Do not use OSIRIS 2 in a hyperbaric chamber.
• For OSIRIS 2 to function correctly, keep the rear air
intakes free of any obstacles, to allow free air circulation.
• In the event of operation in dangerous or explosive
atmospheres, it is imperative that OSIRIS 2 is switched
to position VAC/ACMV 100 % O
• The manufacturer has forseen most cases of possible
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 (IM5,
etc.).
• Efficient ventilation can be ensured by good settings
of the threshold for patients' breath detection (for
restless patients, etc.) as well as good surveillance of
the patient circuit.
• Using other equipment which does not conform to the
safety standards of OSIRIS 2 can cause a reduction
in safety levels. The factors to take into account when
choosing other equipment are its use close to the
patient, conformity to the EN 794-3 standard and
recommendations contained in the accompanying
documentation.
Non-invasive ventilation
• Perfect knowledge of OSIRIS 2 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
2 be used with currently approved monitoring equipment.
Equipment cleaning and maintenance
• Do not use abrasive powders, alcohol, acetone, or other
easily inflammable solvents.
• OSIRIS 2 must be checked regularly. To plan and record
maintenance operations, refer to the maintenance form
in the Appendix.
• Only people who have completely read and
understood this manual are authorized to handle and
use OSIRIS 2.
• The present manual was written to give all the
information necessary for using OSIRIS 2, but is no
substitute for medical instructions, indispensable for
adjustments adapted to the needs of the patient.
• The audible alarm of OSIRIS 2 is intended to be
heard by staff close to the patient. Users must
determine maximum safe distance from the patient
to be able to hear the alarm clearly in the ambiant
sound environment.
YL024400 - V 2.1 - 10/2012
EN
.
2
1