9
7.
RESIDUAL RISK
The residual risks listed below have been identified exclusively in reference to the intended use of the device.
The installation and use without complying with the distances between electrical and electronic devices in reference to electromagnetic
compatibility, could lead to malfunction of such devices.
Installation carried out by untrained personnel can lead to detachment of medical gas pressurized tubes, resulting in damage to people
or impossibility to carry out rescue operations.
Installation carried out by untrained personnel, could result in inadequate fastening of the device inside the ambulance, with consequent
risks related to its instability or mobility.
The connection to a gas supply having impurities or traces of condensate can compromise the good functioning of the device, altering its
functional characteristics and causing harm to patients.
The connection to a power source with higher voltage than described in this manual can make the device not usable.
The connection to a power source with lower voltage than described in this manual can result in a battery recharge failure and in a
device block.
Failure to check the compliance of the pneumatic supply, may result in unattended therapy interruption.
The use in environmental conditions different from those specified in this manual, can damage the sealing elements resulting in leakage
of gas, deviations from the set flow values or condensation.
The use in presence of flammable and/or anesthetic gas may cause fire risks.
A prolonged use without adequate humidification downstream the device, can cause dryness of the patient airways.
The use of Air Mix mode in polluted atmosphere can result in serious damage to the patient.
The use of adult breathing circuits on pediatric patients may cause barotrauma.
Wrong choice of the mask size, can lead to oxygen leakage decreasing the effectiveness of the ventilation therapy or leading to improper
operation of alarms.
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, its essential the presence of an expert doctor who can evaluate the actual benefits provided by the artificial
ventilation and able to determine if the ventilator can be used.
The doctor will be able to assess the type and cause of respiratory
insufficiency, ensuring adequate therapy
evaluating the actual need and possibility to use the ventilator setting the proper values in
relation to the clinical condition of the patient. The absence of such figure can seriously compromise the patient safety because of
inadequate treatment, ineffective or due to an improper use of the device.
Side effects are only partially limited by the time of use of the device, which should never exceed the time for the transport of the patient
on the ambulance. Risks arising from prolonged use, are closely linked to the side effects of NIV.
The reuse of unsterilized patient circuits, involves risks of infection for patients and operators.
8.
TECHNICAL DATA AND COMPONENTS
Note: Spencer Italia S.r.l. reserves the right to make changes to specifications without prior notice.
8.1
Technical data
DIMENSIONALS
Width
269 mm
Height
210 mm
Depth
177 mm
Weight
3,32 ± 0,2 kg
Patient circuit weight
242 g
Patient circuit volume
400 ± 20ml
Power supply
Voltage
12 Vcc (-15% + 25%)
AC/DC Adapter
Input: 100-240VAC, 50/60Hz; 0,7-0,35A
Output: 12V DC
Power consumption max
700 mA
Main battery
12V NiMh 1,8Ah
Autonomy
About 3 hours
Charge time
About 10 hours
Secondary battery
9V 6LR61
Pneumatic supply
Intended gas
Medical oxygen
Input pressure
From 280 to 600 kPa
Maximum flow rate required
140 l/min
FUSE
F1L250V
Fast 5x20mm 1A
VENTILATION
Modality
CMV
Volume/minute
From 2 to 20 L/min
Frequency (
F
)
from 5 to 40 BpM
Pressure limit
from 20 to 60 cmH
2
O
Tidal Volume
𝑉𝑇 =
𝑉𝑜𝑙𝑢𝑚𝑒
𝑚𝑖𝑛𝑢𝑡𝑜
𝐹
FiO
2
60% (AIR MIX) o 100% (NO AIR MIX)