Freedom Innovations VAC-00-A1001-00 Instructions For Use Manual

Brand: Freedom Innovations

Model: VAC-00-A1001-00

Type: Instructions For Use Manual

This manual is also suitable for

Instructions

for

Use

Freedom

iQ™ Vacuum

Contents

Device Components 4

Terms/Symbols Used In This Guide 4

Warnings/Safety Precautions 6

Product Description 7

Intended Use 7

Indications 7

Qualications 7

Product Specications – Physical Properties 7

Environmental Specications 7

Setup 8

Pylon Attachment 8

Maintenance & Cleaning 9

Vacuum Connection and Filter 9

Basic Operations 10

User Panel 10

Turn On 10

Turn O 10

Battery Life 10

Battery Level 10

Reset 11

Warning Indicators 11

Critical Error Indicators 11

Normal Function 11

Battery Charging 11

Freedom iQ Vacuum App for Prosthetists (iQ Vac App) 12

Dashboard 12

Adjust Vacuum Levels 12

Initial Training 12

Step Detection Setup 13

Adjust Target Step Rates 13

Outcomes and Engineering Reports 14

Freedom iQ Vacuum App (iQ Vac App) for Users 15

Interactions 15

Features and Options 15

Water Mode 15

Stop on Leak 16

Vent on Power O 16

Downloading and Launching App 16

Connecting and Pairing to iQ Vacuum via iQ Vac App 16

Disconnecting 16

Warranty 17

Technical Support 17

Electromagnetic Precautions 17

CE Conformity 18

Authorized Representative 18

iQ Vacuum Product Detail 19

Freedom Innovations | iQ Vacuum | Instructions for Use

Freedom

iQ Vacuum™

Device Components

Part Description Part Number Included w/iQ Qty Available/Sold Separately

iQ Vacuum Device VAC-00-A1001-00 YES 1NO

Ø 29 mm Clamp Bushing VAC-00-P0101-01 YES 1YES

Ø 32,6 mm Clamp Bushing VAC-00-P0101-02 YES 1YES

Ø 34,8 mm Clamp Bushing VAC-00-P0101-03 YES 1YES

Filter Assembly VAC-00-A1011-00 YES 4YES

1,6 mm ID Tube OTS-39-00030-00 YES 1YES

3,2 mm 90 Degree Elbow Barb OTS-69-00010-00 YES 1YES

Pylon Bumper, Foam Tape OTS-32-00008-00 YES 1YES

AC/DC Wall Mount Adapter OTS-62-00006-00 YES 1YES

iQ Vacuum Device IFU IFU-03-004 YES 1YES

Terms/Symbols Used In This Guide

WEEE Directive on waste electrical and electronic

equipment, which should not be disposed of in regular

wastes at the end of its usable life

Serial number

Type BF applied part

FCC Declaration of Conformity

Manufacturer

Bluetooth

CE Mark

Battery

iQ Adaptive Vacuum Device

Consult operating instructions

Don Put on

Do Take o

CP Certied Prosthetist

Freedom Innovations | iQ Vacuum | Instructions for Use

Warnings / Safety Precautions

• Failure to comply with safety precautions can result in iQ Vacuum

malfunctioning and risk of injury to the user. Please read the

instruction manual thoroughly before using.

• Always exercise good judgment and common sense when using

iQ Vacuum.

• Initial operating of iQ Vacuum should be done in the presence of a

trained care professional.

• Do not attempt to open or modify any component of iQ Vacuum.

• If any issues or concerns with the iQ Vacuum arise, contact a

Prosthetist for assistance. DO NOT attempt to make technical

repairs.

• Do not continue to use the iQ Vacuum if the plastic cover enclosure

is broken.

• Do not use iQ Vacuum while the battery is charging. Be sure to

disconnect it from the charger prior to putting on the prosthesis.

• If it becomes necessary to isolate iQ Vacuum from the mains while

charging, unplug the battery charger.

• If unusual movement or product wear is detected in a structural

part of a prosthesis at any time, immediately discontinue use of the

device and consult a clinical specialist.

• iQ Vacuum contains a Lithium-polymer battery. Lithium-polymer

batteries contain hazardous materials and should never be disposed

of in residential or commercial garbage. They should never be

incinerated because they may explode. Reference local regulations

for proper disposal of product.

• iQ Vacuum has small parts and a charging cord that can be a

potential choking hazard.

Product Description

Freedom iQ Vacuum is a microprocessor controlled, automatically

adjusting vacuum that monitors activity to control the amount of

pressure in the prosthetic socket for the changing needs of the user.

Intended Use

Freedom iQ Vacuum is intended for use by individuals with lower limb

amputations who would benet from improved socket environment

and physical connection to their prosthesis.

Indications

Freedom iQ Vacuum is indicated for use as a component in a prosthetic

leg for individuals with lower limb deciency including:

• Persons or Individuals with unilateral or bilateral

transtibial amputations

• Individuals with congenital limb loss below the knee

Qualications

Freedom iQ Vacuum should only be integrated in the prosthesis by

a trained O&P professional.

Product Specications – Physical Properties

No weight limit for users of all activity levels.

Average Product Weight: 271 g

Build Height: no additional build height for standard Pylon

(a minimum of 50,8 mm – 76,2 mm of pylon/adapters are required)

Suitable for ambulatory level: K2 – K4

iQ Vacuum is tested and compliant with the following standards:

• IEC/EN60601-1

Environmental Specications

• Operating Temperature Range: 0 to 45 °C

• Storage Temperature Range: -25 to 70 °C

• Humidity Range: 0 – 100%

• Altitude Range: 0 – 3,350 m

• Weather resistance: rated to IP67

- iQ Vacuum should be powered o or put into Water Mode if

submersion is anticipated.

- iQ Vacuum is safe for occasional submersion in fresh water

up to 1 m for up to 30 minutes.

The user should dry the device with a towel once out of the water.

- iQ Vacuum should not be used for bathing or showering.

- iQ Vacuum should not be immersed in salt water or chlorinated

water as these may cause corrosion.

Freedom Innovations | iQ Vacuum | Instructions for Use

Setup

iQ Vacuum is designed to not require additional build height by

clamping on to the prosthesis pylon or adapter. The amount of height

required between the socket and the foot depends upon the top prole

of the prosthetic foot chosen.

Pylon Attachment

Remove the front cover screw to reveal the clamp. Remove the two

clamp bolts. Select a rubber clamp bushing from the included kit to

wrap around the pylon or adapter. The clamp on the main body of

the iQ Vacuum unit should t snuggly against the pylon and rubber

shim. Position the unit as high as possible on the posterior side of the

prosthesis pylon. Take care that there is no contact with the socket or

the foot when mounted. If desired, the provided self-adhesive foam

pylon bumper should be attached at the bottom of the housing below

the serial number label. Attach the anterior clamp with the two clamp

bolts and tighten with a torque wrench to 5 Nm. Check that the unit

is held rmly and does not slip. You may have to choose a dierent

thickness of rubber clamp bumper if it is not secure, or if you cannot

tighten the clamp fully. If needed, you can attach the unit to any side

of prosthesis for a better t.

Maintenance & Cleaning

iQ Vacuum was designed for no internal service requirements for

the life of the device.

In order to maintain the IP67 rating, the external case of the iQ Vacuum

should never be open except for authorized service. The Water Mode

should always be activated when entering the water.

The external lter of the iQ Vacuum should be replaced every 6 months.

The iQ Vacuum Pump may be cleaned by wiping it using a soft cloth

with mild soap and water. Do not use any other solvents. Do not

immerse to clean.

Vacuum Connection and Filter

With iQ Vacuum securely fastened to the prosthesis, attach the lter

assembly with 3,2 mm tubing to the socket barb tting, which should

be as close to the bottom of the socket as practical.

Connect the 1,6 mm tubing to the lter assembly and route it to the

proximal barb on the iQ Vacuum pump. Ensure the tubing passes

through the proximal relief cutout in the housing. Cut the tubing to

length as necessary.

Filter Assembly

Cut Vacuum Line

Freedom Innovations | iQ Vacuum | Instructions for Use

1110

Basic Operations

User Panel

To manually control iQ Vacuum, use the button and LED indicator on

the top of iQ Vacuum. The button is used as both a power switch and

for limited interaction with iQ Vacuum when a mobile device is not

available or desired.

Power / Function Button

Battery / Function Indicator

Turn On

Don the prosthesis prior to turning on. Press and hold the center

button until the indicator light turns green, then release. A series of

green ashes follow to report the battery charge.

Indicator Light Charge Level

4 Green Flashes

3 Green Flashes

2 Green Flashes

1 Green Flash

75% – 100%

50% – 75%

25% – 50%

0% – 25%

The amber light turns on after battery report ashes, and indicates

that the pump is pulling vacuum to donning level.

Turn O

Press and hold the center button until the indicator light turns green,

then release. A green ash followed by an amber LED will indicate the

unit is o. The amber LED remains lit while a relief valve is held open

to aid in dong the prosthesis.

Battery Life

2 – 3 days under normal operating conditions.

Battery Level

A quick press of the button (while on or o) will display the battery

level according to the pattern above.

Reset

While plugged into its charger, press and hold the button for

15 seconds. The indicator light will turn amber when ready to reset.

Release the button and a ashing red light will indicate that the

rmware is resetting. If you decide not to reset, simply continue

pressing the button until the amber light turns o.

WARNING: A reset will erase all memory and restore factory settings.

Warning Indicators

The indicator will glow amber steadily under the following conditions:

• Battery Low

• Socket Seal Leak

• Blockage of Vacuum

• Unable to Reach Donning Vacuum Level

Critical Error Indicators

The indicator will ash red quickly for 10 seconds and the unit will turn

o automatically under the following conditions:

• Battery Too Low to Continue

• Unresolved Socket Seal Leak

• Continuing Blockage of Vacuum

Normal Function

iQ Vacuum will initially start up in “Donning Mode” and will apply a

slight vacuum to the prosthetic socket. Intelligent diagnostics will test

the quality of the socket seal and then will enter “Auto Mode” where it

will automatically increase and decrease the vacuum level based on the

activity level of the user. If it is unable to achieve the donning level in a

short time, the warning indicator will illuminate amber. Check for leaks

in the socket or tubing connections and don the prosthesis again.

Battery Charging

To charge the battery:

• Insert micro USB cable connector into port on side of iQ Vacuum.

• Connect to the wall power supply provided with iQ Vacuum.

The indicator will slowly pulse green while charging.

• Once the device is completely charged, the indicator light will

turn solid green.

CAUTION: Use only the wall power supply provided with iQ Vacuum

for charging its battery.

Freedom Innovations | iQ Vacuum | Instructions for Use

1312

Freedom iQ Vacuum App For Prosthetists (iQ Vac App)

Dashboard

After connecting to an iQ Vacuum unit, an information Dashboard

summarizes key setup and performance indicators. The live graph

at the bottom of the screen shows you how the socket vacuum is

changing and how the vacuum is responding to the live changing

activity of the user.

Adjust Vacuum Levels

While iQ Vacuum is fully automatic, the amount of vacuum targeted

at dierent activity levels is adjustable by the prosthetist by selecting

Controls>Settings>Vacuum Level.

Initial Training

For optimal automatic function, iQ Vacuum must be trained to

recognize the unique gait of the user. Before training, you may choose

to alter the standard target vacuum levels. In the Freedom iQ Vacuum

select Controls>Settings>Step Detection Setup. The app will lead you

through the process of tuning the iQ Vacuum sensor.

The process can be repeated by the prosthetist at any time in the

future should there be a question about the performance of the

adaptive control system, or if the target vacuum levels are changed.

Step Detection Setup

To use Step Detection Setup, have the user walk continuously. Each

time that the device observes a step, the gray circle in the middle will

ash green and there will be an audible beep. Make sure the sound

on your mobile device is turned on and the volume is up. There should

be one ash/beep for each step you observe. Ignore starting, stopping

and turning steps. After watching the user for several steps, tap the

control on the screen that reects if the device detected:“Too Few”,

“Too Many” or “Just Right” number of steps. Continue the process until

it is “Just Right”. Tap “Just Right” at the bottom of the screen. Be sure

to observe the user at a variety of cadences.

Adjust Target Step Rates

The vacuum level target increases with increasing activity levels

(Low, Medium, High) as dened by the target step rates. These are

adjustable by selecting Controls>Settings>Step Rate in the app menu.

You may want to increase the rate if you feel the device is going into

medium or high activity mode too early or you may want to decrease

the rates if the user does not achieve the higher activity levels.

Freedom Innovations | iQ Vacuum | Instructions for Use

1514

Outcomes and Engineering Reports

iQ Vacuum is designed to collect and provide both performance and

qualitative outcomes of the prosthesis user. Select Report from the

bottom right of the main screen, or tap Controls>Create Usage Report.

The report on screen may be emailed, le transferred, or printed

depending on the mobile device you are using.

An Engineering Report can be created in .CSV format by selecting

Controls>Device>Engineering Report. The Engineering Report oers

more detailed session data for the last 100 sessions of use.

Freedom iQ Vacuum App (iQ Vac App) for Users

Interactions

The iQ Vac App for users allows the user to interact with

iQ Vacuum on a more limited basis:

• View Battery Charge Level

• View Current Activity Level

• View Seal Quality

• View Step Counts (Current session and lifetime)

• Activity Level Step Rates

• View Target and Live Vacuum Levels

• View Warning Details

• Create Outcomes Report to Send to Prosthetist

• Set A Custom Name For The Device

• Set The Service Date When The Vacuum Filter Is Changed

NOTE: User will not be able to connect via the iQ Vac App when

iQ Vacuum is simultaneously connected to another mobile device.

WARNING: Users should not watch the screen on their mobile

device while walking.

Features and Options

The iQ Vac App allows users to customize their interactions with

the iQ Vacuum.

Water Mode

Users can safely enter the water with the iQ Vacuum

by activating Water Mode. Select 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 user can safely enter the

water without fear of damaging the device. Once out of the water,

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 mode.

WARNING: Users should ensure that there is no water intrusion into

the socket of their prosthesis before turning the device back on.

Water inside the socket will be pumped through the device and may

cause damage.

Freedom Innovations | iQ Vacuum | Instructions for Use

1716

Stop on Leak

The user may toggle the Stop on Leak feature on or o from the

Settings menu (Controls>Settings>Misc). While toggled on, the Stop

on Leak feature will automatically power down the iQ Vacuum when

a faulty seal is detected, preventing continuous running and possible

damage. In circumstances where the user desires to continue

wearing the prosthesis in spite of a leak, toggling Stop on Leak o

will cause the iQ Vacuum to alternate between pump and rest, instead

of turning o.

Vent on Power O

The Vent on Power O feature is available to users through the

Settings menu (Controls>Settings>Misc). The Vent on Power O

feature enables the user to set a time in seconds that the iQ Vacuum

should vent vacuum (allow air to come in) each time it is powered

down, helping users in removing their prosthesis.

Downloading and Launching App

Download the iQ Vac App from the Apple App Store or the

Google Play App Store.

Connecting and Pairing to iQ Vacuum via iQ Vac App

• Once App is open, tap the “Connect” button.

• Tap the ID number (or custom name) of the iQ Vacuum to connect.

NOTE: When connecting to iQ Vacuum with a mobile device for the

rst time, the iQ Vac App will instruct the user to hold their mobile

device very close to the iQ Vacuum unit to ensure this is an authorized

wireless request.

Disconnecting

When you are done interacting with iQ Vacuum, select

Controls>Disconnect to disconnect the Bluetooth connection to

iQ Vacuum. This will conserve battery power.

Warranty

Purchase of the iQ Vacuum includes a 24-month warranty covering all

manufacturer defects eective only if the product is used according to

manufacturer recommendations.

Technical Support

• For User Support, please contact Prosthetist.

• For Prosthetist Technical Support or supplementary training

material please contact Freedom Innovations at +31 53 20 30 300.

Electromagnetic Precautions

The Freedom iQ Vacuum™ needs special precautions regarding

electromagnetic compatibility (EMC). Specically it needs to be

installed and put into service according to the EMC information

provided as follows:

• This device complies with Part 15 of the FCC Rules. Operation

is subject to the following two conditions: (1) this device may

not cause harmful interference, and (2) this device must accept

any interference received, including interference that may cause

undesired operation.

Guidance and Manufacturer’s Declaration

– Electromagnetic Emissions

iQ Vacuum is intended for use in the electromagnetic environment

specied below. The customer or user of iQ Vacuum should assure that

it is used in such an environment.

Emissions

Test Compliance Electromagnetic Environment –

Guidance

RF Emissions

EN 55011/CISPR

Group 1 iQ Vacuum uses RF energy only for

internal functions. Therefore, its RF

emissions are low and are not likely

to cause any interference in nearby

electronic equipment.

RF Emissions

EN 55011/CISPR

Class B iQ Vacuum is suitable for use in all

establishments, including domestic

establishments and those directly

connected to the public low-voltage

power supply network that supplies

buildings used for domestic purposes.

Freedom Innovations | iQ Vacuum | Instructions for Use

1918

iQ Vacuum Product Detail

CE Conformity

The Freedom iQ Vacuum is tested and certied to comply

with the MDD 93/42/EEC (EN 55011 Class B and IEC60601-1

and IEC60601-1-3), STSI EN 300-328 under R&TTE Directive

1999/5/EC and, ISO10328. The device complies with Part 15

of the FCC Rules and carries the CE mark.

Authorized Representative

Advena Ltd.

Pure Oces

Plato Close, Warwick, CV 34 6 WE

United Kingdom

A. Power/Function Button

B. Micro USB Charging port

C. Pylon Clamp

D. Foam Pylon Support Pad Location

Basic Button Functions

Press and hold until indicator light turns green then release

Quick tap (less than 1/2 second) to report battery level when On or O

Quick tap (less than 1/2 second) to restart donning mode if failed

Freedom Innovations | iQ Vacuum | Instructions for Use

Freedom Innovations Europe B.V.

Jaargetijdenweg 4

7532 SX Enschede

The Netherlands

Tel.: +31(0)53-20 30 300

Fax: +31(0)53-20 30 305

www.freedom-innovations.eu

[email protected]

iQ Vacuum™ is a trademark of Freedom Innovations, LLC.

IFU-03-004 Rev. A - iQ Vacuum Instructions for Use, English EU

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Freedom Innovations VAC-00-A1001-00 Instructions For Use Manual

Brand: Freedom Innovations

Model: VAC-00-A1001-00

Type: Instructions For Use Manual

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Freedom Innovations VAC-00-A1001-00 Instructions For Use Manual

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