Side Effects; Warnings And Safety Information - Saadat Respina P1 User Manual

 If there is no alternative ventilation method and equipment that can be used as a
backup.
 Connected the device to an inadequate electric mains power (e.g. without earth
connection).
 With gas supply which do not meet medical grade specifications.
It is NOT possible to use the ventilator when any of the following events occurs:
 Never use it in the presence of flammable anesthetic gases.
 Do not use nitric oxide, helium or mixtures containing helium as input gas supply.
 The ventilator is located in the vicinity of MRI equipment or significant sources of
electromagnetic radiation.
 During the inter hospital transfer of patients (mobilization outside the assigned
institution).
 Failure to strictly comply with the instructions for use, user and intended use
environment for this ventilator.
 If the ventilator is located in a hyperbaric chamber.
It is the responsibility of the user to select the appropriate ventilation mode for the underlying
disease of the patient. For all ventilator settings, the user needs to consider the respiratory
status and the general state of health of the patient in order to optimally adapt the ventilation
settings to the patient's condition.
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Side effects

The instructions for use do not discuss about risks that are obvious to users, consequences of
obvious improper use of the ventilator and potentially negative effects on patients with one or
more illnesses.
Generally, mechanical ventilation may lead to negative effects, such as barotrauma or strain
on the circulatory system. Proper selection of ventilation mode and suitable adjustment of
setting parameters could decrease potential occurrence of such effects.
Side effects of NIV ventilation includes: ear discomfort, conjunctivitis, skin abrasions due to
mask/patient interface, and gastric distention (aerophagia).
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Warnings and safety information

Warning
Read User manual carefully before operating the ventilator system
The system function can be affected by using unapproved accessories.
The ventilator should only be operated and maintained by trained personnel. In
addition all patients requiring ventilation must be monitored appropriately by
qualified medical personnel.
The guidelines for the use of approved accessories, checking the device function and
the use of the device in appropriate environmental conditions should be followed by
healthcare center.
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