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12.
CLEANING AND MAINTENANCE
12.1
Cleaning
Failure to carry out the correct cleaning routine could increase the risk of cross infection, due to presence of body fluids and/or residuals.
The operator must always wear adequate personal protection such as gloves and mask, etc. during all checking and cleaning procedures.
The described operations must be performed after each use of Spencer 170.
Turn off the device
Isolate it from the power supply (if connected)
The cleaning of the external parts of the device can be carried out using suitable disinfectants for surfaces as described in this table:
USABLE PRODUCTS
NOT USABLE PRODUCTS
Disinfectants with aldehydes
Compounds that release halogens
Disinfectants with alcohol
Strong organic acids
Quaternary ammonic compounds
Compounds that release oxygen
Trichloroethylene
Be careful to ensure that no kind of solution enters inside the oxygen socket..
If is used a disposable patient circuit, replace it.
If is used a reusable patient circuit, disassemble every part and sterilize according to a validated procedure.
Similarly, replace or sterilize the mask.
After confirming the ventilator and all accessories are completely dry, is possible to reconnect the device to the power supply.
The use of high pressure water is prohibited
,
because it should penetrate into the device causing risks of corrosion of components
and risks of electric leakage and short circuits. During every cleaning procedure, check that were not used any kind of lubricants.
12.2
ORDINARY maintenance
Establish a maintenance program and periodic testing routine, identifying an employee responsible for this. The person to whom the
ordinary maintenance of the device is entrusted must ensure the basic requirements foreseen by the manufacturer in following paragraphs
are inspected.
All maintenance and periodic servicing activities must be registered and kept together with the servicing reports. These documents have to
be kept for a period of 10 years after the disposal of the device itself. This register will be made available to the competent authorities
and/or manufacturer if requested.
To guarantee the traceability of the products and to protect the procedures of maintenance and assistence of Yours devices, Spencer has
made available the ASSTEC portal
http://service.spencer.it/asstec/login.aspx
, which will allow you to view the data of the products owned
or on the market, to monitor and update the plans of periodic reviews, to view and manage extraordinary maintenances.
Routine maintenance of the device must be carried out by operators in possession of specific qualifications, trained and experienced in the
use and maintenance of the device.
The operator must always wear adequate personal protection such as gloves and mask, etc. during all checking and cleaning procedures.
Checks to be carried out before and after each use and at deadline indicated above, are as follows:
General functionality of the device
Cleanliness of the device (remember that the failure of cleaning may cause the risk of cross infections)
Correct fixation of all nuts, bolts and screws
No structural part is deformed or compromised
Proper operation of the pressure limiting adjustment controls. With the device turned on, occlude the patient output and verify that
the manovacuometer shows the pressure value set within the tolerances described in the technical data. Verify proper functionality of
the frequency knob setting a value and measuring the time between two mandatory ventilations. The time in seconds between two
ventilations is equal to 60/Frequency.
12.2.1
9V alarm battery check
The 9 V backup battery must be regularly checked or replaced depending on its use. Using a tester ensure that the voltage on the battery is
not lower than 40%. The correct polarity when connecting the 9 V battery is guaranteed by one-directional connector.
The alarm battery must be replaced once a year even if in good conditions.
12.2.2
Internal battery status check
The device is powered by a rechargeable battery. A new battery is never fully charged. It will be fully charged only after being charged for 7
consecutive hours before the first use of the device. The battery recharges automatically when the device is connected to the external
power source.
If the device is not used for a long time, the battery must be recharged.
Do not keep the unit in charge beyond the time specified. Fully discharge the battery and / or maintain the equipment continuously
powered from external source, results in a significant reduction of the operating life of the battery.
The internal battery must be replaced once a year even if in good conditions.
All batteries should be removed if the device needs storage. The absence of the internal battery should be indicated on te device (for
example with a label) so that the device will not be accidentally used without the internal power supply. To limit the battery aging, it is