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14.
SIDE EFFECTS
There are no known side effects directly associated with the device.
Any serious incident that has occurred in relation to the device should be reported to the manufacturer and to the competent
authority of the Member State in which the user is established.
15.
MAINTENANCE AND CONTROL
No maintenance operation such as lubrication, work on the screws or other parts is required.
It is recommended that the foot be inspected by the prosthetist at least every six months to check for damage to any components
that may compromise the performance. Inspections at shorter intervals are recommended if the user is more active.
The Spectra sock and the foot shell should also be evaluated by the prosthetist at regular intervals, depending on the patient's
level of activity. If these parts are damaged, it can lead to premature foot wear.
The lifetime of the foot depends upon the patient's level of activity.
The EVAQ8 models' components (tubing, inline filter, one-way valves housed inside the Valve Body Assembly, etc) may need
periodic cleaning or replacement during the life cycle of the system and are not replaceable under the warranty as it is considered
normal wear.
16.
PERIODIC INSPECTION OF THE EVAQ8 SYSTEM
•
Visually inspect the tubing for kinks, cracks, or wear that may leak air into the system. Replace tubing if any of these
conditions exist.
•
Remove the inline filter from tubing and look through it. If light can be seen, the filter is clean. If light is blocked, push air
from a syringe through the inline filter from distal to proximal end (reverse of normal flow) to attempt to clear the
blockage. If blockage persists, the filter needs to be replaced.
•
The one-way valves contained in the vacuum heel may need to be cleaned and flushed with distilled water or isopropyl
alcohol to ensure proper function. This procedure should only be done by a qualified professional.
1. Valve Body Assembly
•
To flush the one-way valves and vacuum pump:
•
Disconnect the vacuum hose from the socket barb and remove the EVAQ8 foot from the user's socket.
•
Place the socket end of the vacuum hose into isopropyl alcohol or distilled water and slowly cycle the vacuum pump
by compressing the heel of the foot with a T-bar or similar until the liquid can be seen coming out of (2) Exhaust
Filter.
•
After a few cycles of fluid flowing through the system, remove the hose from the isopropyl alcohol or distilled water
and cycle the pump slowly until no more fluid is exiting through the exhaust filter.
•
Reconnect the pump and vacuum hose.
•
To service and clean, or replace the components:
•
Remove the vacuum hose from the user's socket keeping it attached to the EVAQ8 foot.
•
Remove the EVAQ8 foot from the user's socket.
•
Remove the vacuum hose from the EVAQ8 foot.
•
Remove (1) Valve Body Assembly from the rubber pump by pulling on it, while rocking side to side.
•
5
Using a
⁄
" socket, remove the (2) Exhaust Filter from (1) Valve Body Assembly.
16
•
Carefully tap the end of (1) Valve Body Assembly against your hand or on a table to allow (3) Spacer and (4) Duckbill
Valve (exhaust) to slide out and allow removal from (1) Valve Body Assembly.
NOTE: (4) Duckbill Valve (exhaust) will likely be pressed into the bottom of (3) Spacer.
•
1
Using a
⁄
" deep socket, remove (7) Straight Barb from the other side of (1) Valve Body Assembly.
4
•
Inside (1) Valve Body Assembly beneath where the (7) Straight Barb was located is another (6) Duckbill Valve (intake).
INSTRUCTIONS FOR USE
2. Exhaust Filter
3. Spacer
4. Duckbill Valve (exhaust)
5. Valve Body
6. Duckbill Valve (intake)
7. Straight Barb
Page 5 of 7
IFU-02-005
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