8
When the device is being used, the assistance of qualified staff must be ensured.
The device must always be accompanied by a replacement unit and/or by a manual ventilation system in order to ensure the possibility
to intervene on the patient in any case. The use of
If connected to the 220V main supply by an adapter, is necessary that its features are like the ones described in this manual, has passed
the test for electromagnetic compatibility according to EN 60601-1-2 and electrical safety according to IEC 60601-1 and IEC 62353
reporting the specific marking, and does not affect the electrical safety and electromagnetic parameters of the ventilator.
The batteries of the device must be replaced every year regardless of the number of recharge cycles.
Do not leave the patient without the assistance of at least one doctor or operator with clinical skills on artificial ventilation when the
device is used.
The device is equipped with warranty seals. If removed, the manufacturer will no longer recognize the product warranty and accepts no
responsibility for improper operation or damage caused by the device.
If the device comes with disposable accessories, these should be used of only one patient. Cannot be washed, sterilized or re-sterilized
after use.
If the device comes with accessories with limited lifespan, do not use them after the expiration date.
The device should not be exposed to or come into contact with any source of combustion or inflammable agents.
Store in a cool, dry, dark place and do not expose to direct sun.
Do not store the device underneath any heavy objects which could cause structural damage.
Store and transport the device in its original packaging.
Position and adjust the device taking care not to cause any obstruction to rescuers and or any other rescue equipment.
The device must be used in a ventilated environment.
The utilization of the ventilator with power sources and environmental conditions different from the indicated ones compromises the
safety of the operations and of the device itself.
Do not lubricate any part of the device. It’s not required by any kind of maintenance and could cause fire hazard.
The artificial ventilation can have side effects. In order to identify the hazards associated with the use of the device, related to the clinical
conditions of the patient, is essential the presence of an expert doctor who can evaluate the actual benefits provided by the artificial
ventilation and who is able to determine if the ventilator can be used. Side effects are only partially limited by the time of use of the
device, intended for emergency and not for prolonged therapy.
For the use of the ventilator, a specialized doctor must be present. The doctor will be able to determine if the technical specifications of
the device makes it suitable to be used on a specific patient and will be the sole responsible for the definition and setting of the
ventilation parameters.
Do not use the device in presence of inflammable substances and anesthetics.
The device is not intended for use in oxygen enriched environment.
Do not use the device if the condition of the paragraph 9 are not met.
Do not use the device if it has not been subjected to scheduled maintenance or maintenance required by a normal use.
Use only accessories approved by the manufacturer.
Do not connect the device to the patient through antistatic conductive tubes.
The installation must be performed ensuring appropriate distances between devices that could have each other electromagnetic
interference as specified in paragraph 9.
The device is intended for NIV and, as such, is generally not suitable in the following cases:
Respiratory arrest or severe cardiorespiratory impairment – Uncooperative patients (coma, shock, altered state of consciousness) –
Excessive secretions – copious bronchial secretions and/or need of frequent suction – Vomiting – Inability to protect upper airways –
Obstruction of upper airways – Cranio-facial trauma or burns – Recent facial, upper gastrointestinal tract or upper airways surgery –
anatomic lesions of the upper airways - Life-threatening hypoxemia – Hemodynamic instability – Sever comorbidities – Undrained PNX –
Sever obesity.
NIV may have complications related to the interface or administred gases, including: Discomfort, facial erythema, claustrophobia,
inhalation of gastric regurgitation, nasal congestion, dry mouth, eye irritation, barotrauma, intolerance and agitation, hypoxia due to
mask removal.
6.1
Requirements of operators
Spencer 170 is a device intended for professional use only. Each operator must be trained in their use and maintenance of
good operating conditions. Do not allow untrained people to assist in the use of the product, as this may cause injury to
themselves or others.
Installers and operators must know all the standards applicable to the devices, accessories and systems connected to the
pulmonary ventilator.
Operators must be able to assess the integrity of the connections. They must also be able to evaluate any anomalies of the
supply systems communicating the problem to the responsible figures, interrupting the use of the devices connected to it.
The abilities of all operators must be considered before determining their role in the employment of the device.
The device can be used only by specialized staff which will be able to determine if the technical specifications of the device
make it suitable to be used on a specific patient and will be the sole responsible for the definition and setting of the
ventilation parameters.