General Safety Instructions - ResMed Elisee 150 Clinical Manual

1 General Safety Instructions

The following are general safety instructions. Other specific warnings and notes can be found
throughout the text of the manual. This manual must be read and understood in full by the user
before the device is used by a patient.
Use
•
The Elisée 150 must not be covered or positioned in a way which could impede ventilation.
•
Before connecting the patient to the ventilator, check the whole of the patient circuit to
eliminate any risk of leaks or defective parts.
•
Alarms should be checked and adjusted before the device is used for a new patient. They
should also be checked and adjusted regularly when the device is being used for home
ventilation. These checks could be included in regular servicing.
•
The ventilation settings must be decided and applied under the supervision of a physician or
qualified and trained staff.
•
Do not use the ventilator with antistatic or electrically conductive patient circuits.
•
It is recommended that you have an alternative means of ventilation available.
•
For ventilation-dependent patients, it is vitally important that you monitor the ventilator while
it is in operation. Ensure that the person caring for the patient is capable of taking the
necessary corrective action if an alarm is triggered or if the device malfunctions.
•
Do not use the ventilator if there are obvious external defects or unexplained changes in
performance.
•
The ventilator and its clinical manual have received CE marking (notified body: TÜV Rheinland,
CE 0197). All accessories used must be CE-marked and must comply with the relevant
standards.
Operation
•
Do not use this device in the presence of flammable anaesthetic agents.
•
Several different pressure measurement units are used in this manual, to correspond to the
usual measurement units. 1mbar = 1hPa = 1.016cmH
•
The user must ensure that the total resistance of the patient circuit and ventilation
accessories does not exceed 6hPa (= 6.096cmH
ventilation, or 6 hPa for a flow rate of 30L/min in paediatric ventilation.
Technical characteristics
•
The pressure in the device will not be lower than atmospheric pressure during the expiratory
phase.
•
The maximum pressure delivered by the device cannot exceed 60 - 70hPa
(= 61.0 - 71.1cmH
•
The ventilator design ensures that, if the device were to stop, the patient would be able to
breathe spontaneously and would not rebreathe exhaled air.
NOT013189-6
O).
2
O.
2
O) for a flow rate of 60 L/min in adult
2
General Safety Instructions 11/174