7
The activities of disinfection and sterilization should be carried out in accordance with the parameters given in the validated cycle as
specified in the technical standards. Sterilization could reduce the lifespan of the devices.
Don’t use accessories after the expiration date indicated on the package, if present.
With reference to the D. Lgs. 24th February 1997, n. 46 emended by D. Lgs. 25/01/2010, n. 37 – Acknowledgement of Directive
93/42/CEE and 2007/47/CE concerning Medical Devices, we remind both public and private operators, , That in the exercise of their
activity detect an accident involving a medical product are required to notify the Ministry of Health, under the terms and in the manner
established by the relative ministerial decrees and also to the manufacturer. Health care providers whether public or private are
required to communicate to the manufacturer, any other inconvenience that may allow for the adoption of measures to ensure the
protection and health of patients and users
6.
SPECIFIC WARNINGS
The device is intended to be used on medical vehicles and not for home therapy.
The device should be used only in a professional healthcare environment except near active HF SURGICAL EQUIPMENT and the RF
shielded room of an ME SYSTEM for magnetic resonance imaging, where the intensity of EM DISTURBANCES is high. The installation
should consider the parameters described in paragraph 9 according to electromagnetic compatibility.
Portable and mobile RF equipment can affect the operation of the device.
The installation and placing of the device must consider what is described in tables of paragraph 9 in order to ensure that the device
maintain its essential performance and basic safety.
Use of cables or power supplies other than those approved by the manufacturer, can adversely affect the electromagnetic performance
of the device.
The use of RF equipment, including antennas, can adversely affect the device. The lung ventilator or its supply cables should be kept
away from other devices according to parameters listed in paragraph 9.
The use of accessories other than those approved by the manufacturer, may result in increased electromagnetic emissions or reduction
of the immunity level of the device.
The device should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the device should be
observed to verify normal operation in the configuration in which i twill be used.
Failure to follow warnings related to electromagnetic compatibility, can compromise the essential performance or basic safety of the
device, affect the proper operation of components, affect the software, unexpected change or behavior in the ventilation mode, false
alarms, interruption of operations or wrong measurement of ventilation parameters.
Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer
than 30 cm (12 inches) to any part of the device, including cables. Otherwise, degradation of the performance of the equipment could
result.
In order to maintain the basic safety and the essential performance of the device, is essential to check before and after each use, the
integrity of the electrical connections and to verify that the environment in which the device is installed has not been changed for
example by installation of additional devices.
Don’t use the device in patients between 0 and 18 months and with not drained pneumothorax.
Do not use the device on patient in respiratory arrest, or that don’t have minimal essential breathing capacity.
The device is intended for NIV. It is not suitable for procedures requiring intubation.
Do not use if the device presents any kind of damage or poor cleaning state.
The proper operation of the lung ventilator, is closely linked to the suitability of the pneumatic power source. Is therefore essential to
check that pneumatic supplies comply with requirements described in this manual as well as to specific guidelines and standards for such
devices.
Ensure that the medical gas supply, is free from condensation, residual materials and/or substances which may compromise the
proper operation of the device and the efficacy of the therapy and that should contaminate the patient.
The device must be protected from bumps, falls and spillage of liquids that could damage the device.
Remove the battery if the device is stored or when unused for a long time.
The device must be used by a physician trained in the use of this product.
The user must not have impairments that prevent proper reading and interpretation of informations displayed on the device and prevent
proper operation of controls.
Do not wash or clean the device with water jets or pressurized air.
Do not use drying machines
Condensation, water, ice and dust accumulation can affect the correct functioning of the device, making it dangerous for the patient and
for the operators.
Before and after each use, check the status of enclosures and of the fixing system of the device; if altered or yielding is noticed, is
necessary to restore its sefety status before use the device. Otherwise we assume no responsibility about proper functioning or any
damage caused by the device.
Regularly check the status of connections to the medical gas supply system as well as the electric ones.
Before turning on the device, charge the battery for at least 7 hours
The battery should never be completely discharged.
If any failure or incorrect functioning of the device is detected, the ventilation must be immediately restored with a similar device or a
manual one in order to ensure the life support functions without interruption
Before each use of device the perfect operating state of the device must be checked as specified in the Instruction manual. If any damage
or abnormalities which could in any way influence the correct functioning and the safety of the device, of the patient and or of the user
are detected, the device must be immediately removed from service and the Manufacturer must be contacted.
When the device is being used, the assistance of qualified staff must be ensured.