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over torquing will snap the threads on the (7) Straight Barb and will not be covered under warranty.
NOTE: If you do not have a torque wrench, thread (7) Straight Barb until you feel a hard stop and then turn
revolution more.
•
Insert (1) Valve Body Assembly into the rubber module with (7) Straight Barb pointed to the medial side of the foot.
This allows the hose to be routed on the medial side of the pylon (to prevent damage to the tube or snagging while
walking).
•
Reattach the bent 90 degree tubing with the hose and inline filter. Reconnect the tubing to (7) Straight Barb.
•
Put the Spectra Sock and foot shell over the EVAQ8 foot.
•
Reattach the EVAQ8 foot to the user's pylon and socket.
•
Reattach the other end of the vacuum hose to the user's socket. The vacuum hose may be routed to the prosthetist's
preference.
1. Valve Body Assembly
17.
CLEANING
Remove the foot shell and the Spectra sock, clean the foot with clear water and neutral soap and dry carefully.
The foot shell can be cleaned with a damp cloth or sponge.
18.
ENVIRONMENTAL CONDITIONS
Temperature range for use and storage: -20 to 60°C
Relative air humidity: no restrictions
Water-resistant: the device is resistant to occasional immersion and splashes.
19.
DISPOSAL
The feet are made of carbon fiber composite, epoxy, PU polymers, titanium, and stainless steel. The devices and their packaging
must be disposed of in accordance with local or national environmental regulations.
20.
DESCRIPTION OF THE SYMBOLS
Manufacturer
Authorized representative
in the European Union
21.
REGULATORY INFORMATION
These products are CE-marked medical devices and are certified as conforming with Regulation (EU) 2017/745.
INSTRUCTIONS FOR USE
2. Exhaust Filter
3. Spacer
4. Duckbill Valve (exhaust)
Identified risk
Single patient, multiple
use
5. Valve Body
6. Duckbill Valve (intake)
7. Straight Barb
CE marking and year of
st
1
Page 6 of 6
1
⁄
of a
16
declaration
IFU-01-015
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