7
If disposable accessories are used, use only once and for only one patient. Do not wash or sterilize after use. Reuse may cause cross-
infection. Some symbols contained in this manual refers to the standard accessories included in the purchased device.
The activities of disinfection (and sterilization of the accessories if required) should be carried out in accordance with the parameters
given in the validated cycle, as specified in the technical standards. Sterilization could reduce the lifetime of the devices.
Do not 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 if in the exercise of their
activity they detect an accident involving a medical product, they 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 operators whether public or private
are required to communicate to the manufacturer any other inconvenience that may allow the adoption of measures that can 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 must be used only in a professional healthcare environment, except for shielded room for magnetic resonance and near high
frequency surgical equipments. The installation should consider the parameters described in paragraph 9 according to electromagnetic
compatibility.
Portable and mobile RF equipments 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.
The 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 equipments, including antennas, can adversely affect the lung ventilator. It is necessary to respect the distances from the
lung ventilator and its supply cables as listed in the paragraph 9.
The use of accessories other than the one aprroved by the manufacturer can cause increased electromagnetic emissions or a reduction of
the immunity level of the device.
The device should not be used adjacent to or stacked with other equipments. If adjacent or stacked use is necessary, the device should
be observed carefully to verify normal operation in the configuration in which it will be used.
Failure to follow warnings related to the electromagnetic compatibility can compromise the essential performance and the basic safety
of the device. It can affect the proper operations of components, the software, unexpected change or behavior in the ventilation mode,
false alarms, interruption of operations or wrong measurement of ventilation parameters.
Portable RF communications equipments should be used no closer than 30 cm from any part of the device, including cables. Otherwise,
the performance of the device could be compromised.
In order to maintain the essential performance and basic safety 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 by the installation
of additional devices.
Do not use the device with patients of age between 0 and 18 months, and with patients with not drained pneumothorax.
Do not use the device on patients with respiratory arrest or that don’t have minimal essential breathing capacity.
The device is intended for NIV. It is not suitable for procedures that requires intubation.
Do not use if the device presents any kind of damage or poor cleaning state.
The proper operation for the lung ventilator is closely linked to the suitability of the pneumatic power source. Is therefore essential to
check that the pneumatic supplies comply with the 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 or that could 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 the enclosures and of the fixing system of the device; if altered or yielding is noticed, is
necessary to restore its security status before using the device. Otherwise we assume no responsibility about proper functioning or any
damage caused by the device.
Regularly check the status of electrical and pneumatic connections.
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 the device the perfect operating state of the device must be checked as specified in the User 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.