Freedom Innovations iQ User guide

1
Freedom iQ
Vacuum Device
Clinical Setup Manual

Freedom Innovations | iQ Vacuum | Clinical Setup Manual
Contents
Device Components 4
Dashboard Overview 6
Device Requirements 7
Installation 8
Setup 9
Outcome Report 13
Leak Detection 14
Water Mode 15
Technical Support 16
IMPORTANT: This manual is meant to serve as a quick
reference guide.
For more information, please refer to the iQ Vacuum
IFU or call Customer Service at: 888-818-6777

Device Anatomy & Components
A. Power/Function Button & Indicator Light
B. Micro USB Charging Port
C. Vacuum Port (Proximal Barb)
D. Expulsion Port (Distal Barb)
E. Anterior Clamp Cover
Introduction
A
B
C
D
E
F
G

Freedom Innovations | iQ Vacuum | Clinical Setup Manual
5
F. Anterior Clamp
G. Rubber Clamp Bushing
H. 90˚ Barb
I. Posterior Pylon Mount
H
I

Dashboard Overview
Dashboard feature descriptions:
A. Controls: Access to adjustments
B. Activity level: Identies current activity level
C. Seal Quality: Assesses current seal quality
D. Battery Charge Indicator: Current battery charge
E. Vacuum level: Shows current vacuum level settings
F. Step Count: Shows step counts for current session or
lifetime of product
G. Step Rate: Shows current step rate settings
H. Red horizontal Line: Current vacuum level threshold
I. Vacuum Live Reading: Currrent amount of vacuum in
socket color coded by activity level
J. Water Mode: Allows safe water entry
K.Report: Generate usage report
EFG
H
D
C
B
I
A
JK

Freedom Innovations | iQ Vacuum | Clinical Setup Manual
7
Setup Requirements
•90˚ barb mounted in the socket (provided with
purchase)
Mounting Requirements:
•For secure attachment, a minimum of 2-3” of pylon/
adapters are required.
Note: Some tube clamps or double ended adapters may
not allow mounting and will need to be swapped out
if possible.
Socket Requirements:
•We recommend using a Total Surface Bearing (TSB)
socket design which ensures distal contact with the
end of the residual limb.
• Make sure your patient fully understands proper
socket tting guidelines and sock ply management
to ensure a well tting and properly donned socket
with distal contact. A void or air pocket between the
end of the residual limb and the liner or between the
liner and distal socket could create excess negative
pressure on distal tissues causing skin breakdown.
• Liner/Sleeve: Use any cushion or sealing liner or
sleeve you prefer with or without fabric.
Device Requirements
Compatible Setup Compatible Setups
(with modications)
Non-Compatible
Setups
90˚ Barb (without
valve)
Össur UNITY Icelock
544 Series (remove
all valves)
Össur UNITY TT
Valve
Ottobock 4R136=EL
Ottobock Harmony
P2 & P3 (removal of
all in-line valves)
Willow Wood
Limb Logic Setup
Cypress Adaptive
Plate
Ottobock
Harmony E2 & P4
Setup

A
B
C
D
E
Installation:
1. Remove the front cover and clamp (Image A).
2. Attach 1/8” tubing with lter to 90˚ barb in the socket.
3. Connect the 1/16” tubing to the lter assembly and route
it to the proximal barb on the iQ Vacuum pump. Cut the
tubing to length as necessary.
4. Select a rubber clamp bushing (Image C) to ensure the iQ
Vacuum unit ts snuggly against the pylon.
5. Position the unit as high as possible on the posterior side of
the pylon. Make sure there is no contact with the socket or
the foot when mounted. If needed, you may mount the iQ
Vacuum unit on any side of prosthesis for a better t.
6. Attach the anterior clamp with the two clamp bolts (Image
B) and tighten with a torque wrench to 5Nm (4 ft-lb). Check
that the unit is held rmly and does not slip.You may have
to choose a dierent thickness of rubber clamp bushing if it
is not secure, or if you cannot tighten the clamp fully.
7. Ensure the tubing passes through the proximal relief cutout
in the housing (Image E). Then attach anterior cover (Image
A)
Note: Ensure there are no sharp turns or kinks in the tubing.

Freedom Innovations | iQ Vacuum | Clinical Setup Manual
9
Setup
Preparation:
• Download the iQ Vac App from the Apple App Store or
the Google Play App Store.
• Ask patient to don the prosthesis.
Step 1: Connect
Turn on iQ Vacuum unit by pressing and holding the Power
Button on unit until the Indicator Light turns green. As the
iQ Vacuum starts to pull vacuum, ask the patient to stand
up or put weight into the prosthesis to make sure their
residual limb seats completely into the socket.
Open the iQ Vac App and tap Connect. Tap the Serial
Number of iQ Vacuum Pump and follow instructions on the
screen to pair the device.
Step 2: Activate Prosthetist Mode
Tap Controls>Settings>Activate Prosthetist
Mode>Enter Authorization Code (provided in product
packaging)>Activate. Prosthetist Mode allows adjustment
to vacuum settings and timers that are not accessible in
Patient Mode.

Step 3: Set Vacuum Levels
Tap Controls>Settings>Vacuum Levels> adjust
levels needed for different activity levels>Save
• Donning (Vacuum level threshold right after pump
is turned on)
• Low (Slow cadence and default setting for
activities like sitting)
• Med (Medium cadence)
• High (Fast cadence)
Note:
• Vacuum levels will depend on patient activity level
and preference.
• If transitioning from a mechanical vacuum system
where the user is accustomed to lower vacuum
levels, start iQ Vacuum levels lower to allow the
individual’s limb to get accustomed to the new
vacuum levels. Slowly increase vacuum level as
residual limb indicates acceptance of higher vacuum
levels.
• The Low vacuum setting is the vacuum level that
the iQ Vac will default to when sitting, standing still
or resting.

Freedom Innovations | iQ Vacuum | Clinical Setup Manual
11
Step 4: Step Detection
iQ Vacuum adjusts vacuum levels when it detects a
change in activity level or cadence. Step Detection
allows the iQ Vacuum microprocessor to identify a step
for the patient.
• Tap Take Me There from Set Vacuum levels
• Follow instructions on screen to match the beep and
green light ash on app with each patient step. Your
mobile device (not the pump) will beep and show a
blinking light in app and the pump will ash when a
step is detected.
Note:
• Make sure the ringer/sound on your mobile device
is turned on and the volume is turned up.
• If making additional changes to the vacuum levels,
Step Detection will need to be repeated.

Step 5: Step Rate
Ask patient to sit to allow the vacuum level to
drop to the low activity threshold. Once vacuum
level has settled to low threshold, watch the
Dashboard and ask the patient to walk at a slow
pace. The vacuum level should stay in the low
threshold vacuum level. Next, ask the patient to
walk a medium pace. The vacuum level should
jump to the medium activity level threshold.
Next, ask the patient to walk at a fast pace. The
vacuum level should jump to the high activity
threshold. See images below.
Slow Pace
Walking
Medium Pace
Walking
Fast Pace
Walking

Freedom Innovations | iQ Vacuum | Clinical Setup Manual
13
If levels do not adjust appropriately
according to patient’s walking pace, tap
Controls>Settings>Step Rate and adjust the
Medium and High Step rates as needed. Tap
Save and repeat conrmation again by asking the
patient to walk slow, medium and fast paces to
make sure vacuum levels adjust correctly.
Outcome Report
The iQ Vacuum device is designed to collect
and provide both performance and qualitative
outcomes of the prosthesis user.
• PEQ Questionnaire for patient satisfaction and
utility
• Cadence Variation and Step Count

Leak Detection
If a leak is detected, the pump will show a warning
notication in the top right corner of the screen
and will highlight the Dashboard in orange.
The iQ Vacuum pump will then power itself off. If
desired, the user can then turn the unit back on to
start the pump once again and can toggle the Stop
On Leak Option to Off in the app if desired. To do
so, tap Controls>Settings>Misc and slide toggle for
Stop On Leak to desired position.

Freedom Innovations | iQ Vacuum | Clinical Setup Manual
15
Issue Condition
Water Mode
Users can safely enter the water with the iQ
Vacuum by activating Water Mode. Tap Water
Mode from the Dashboard screen and then select
a target vacuum level as prompted. The iQ
Vacuum will pump to that level for 30 seconds
before shutting down and disconnecting from
the iQ Vac App. After the pump has shut down,
the patient can safely enter the water without
fear of damaging the device. Once out of the
water, make sure the inside of socket and liners
or socks are dry. Resume use of the iQ Vacuum
by powering it on once again and reconnecting to
the iQ Vac App. Once powered back on, the iQ
Vacuum will return to normal function.

Technical Support
For Prosthetist Technical Support or supplementary
training material please contact Freedom
Innovations toll-free at 1.888.818.6777
CG-03-007 iQ Vacuum User Guide, Clinician
Connect with us
Global Headquarters
3 Morgan
Irvine, CA 92618
toll free: 888-818-6777
phone: [phone]
fax: [phone]
www.freedom-innovations.com
#freedominnovations
©2019 Freedom Innovations, LLC. All rights
reserved. iQ Vacuum is a trademark of Freedom
Innovations, LLC.