NOTE: If you do not have a torque wrench, thread the (1) Exhaust Assembly until you feel a hard stop and then turn
of a revolution more.
•
Insert the white (8) Duckbill Valve into the recessed side of the heel so the tip of the (8)
Duckbill Valve points into the heel. Using a small screwdriver or a straightened-out (9)
paperclip, make sure the (8) Duckbill Valve is seated all the way into the recess.
•
BY HAND, thread the (7) Straight Barb into the side of the heel that is recessed.
•
Once the (7) Straight Barb is threaded in snugly BY HAND, torque it to 15 in-lbf. This is a very low torque value, and over
torquing will snap the threads on the (7) Straight Barb and will not be covered under warranty.
•
If you do not have a torque wrench, thread the (7) Straight Barb until you feel a hard stop and then turn
more.
•
Reattach vacuum hose to EVAQ8 foot by sliding the vacuum hose over the (7) Straight Barb.
•
Put the Spectra Sock and foot shell over the EVAQ8 foot.
•
Reattach the EVAQ8 foot to the user's 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.
17.
CLEANING
Remove the foot shell and the Spectra sock, rinse the foot in clear water, clean it with neutral soap and dry carefully.
The foot shell can be cleaned with a damp cloth or sponge. It must be dry before reuse.
The devices are not resistant to solvents. Exposure to solvents may cause damage.
18.
ENVIRONMENTAL CONDITIONS
Temperature range for use and storage: -20°C to 60°C [-4 to 140° F]
Relative air humidity: no restrictions
Waterproof: the devices are resistant to fresh, sea, and chlorinated water.
The foot shell is not resistant to ultraviolet light (UV). Do not store it under direct sunlight.
19.
DISPOSAL
The devices are made of fiberglass composite material, rubber, Vibram (H2O), metal and plastic (EVAQ8). 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
Identified risk
Single patient, multiple
use
Page 6 of 6
1
⁄
16
Correct
Incorrect
1
⁄
of a revolution
16
CE marking and year
st
of 1
declaration
IFU-02-012