vacuum device - freedom innovations...freedom innovations iq vacuum instructions for se 7 freedom iq...

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Freedom iQTM

Vacuum Device

Instructions for Use

Freedom Innovations | iQ Vacuum | Instructions for Use

ContentsDevice Components 4Terms / Symbols Used 4 Warnings / Safety Precautions 6Product Description 7 Intended Use 7 Indications 7 Qualifications 7 ProductSpecifications 7 Physical Properties 7 EnvironmentalSpecifications 7Setup 8 Pylon Attachment 8 Alternative 4-Bolt Adaptor 8 Vacuum Connection and Filter 9Basic Operation 9 User Panel 9 Turn On 9 Turn Off 9 Battery Level 10 Reset 10 Warning Indicators 10 Critical Error Indicators 10 Normal Function 10 Battery Charging 10 Freedom iQ Vacuum App for Prosthetists 11 Dashboard 11 Adjust Vacuum Levels 11 Initial Training 11 Step Detection Setup 12 Adjust Target Step Rates 12 Outcomes and Engineering Reports 13Freedom iQ Vacuum App for Patients 14 Interactions 14 Downloading and Launching App 14 Connecting & Pairing 14 Check Battery Charge Level 15 Disconnecting 15 Warranty 16 Technical Support 16Electromagnetic Precautions 17iQ Vacuum Product Detail 18

Terms / Symbols Used

Type BF applied part

WEEE Directive on waste electrical and electronic equipment, which should not be disposed of in regular wastes at the end of its usable life

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Part Description

iQ Vacuum Device

1.142” Clamp Bushings



Filter Assembly

1/16” ID Tube

1/8” 90 Degree Elbow Barb

Pylon Bumper, Foam Tape

AC/DC Wall Mount Adapter

iQ Vacuum Device IFU

Device Components

Part Number

VAC-00-A1001-00

VAC-00-P0101-01

VAC-00-P0101-02

VAC-00-P0101-03

VAC-00-A1011-00

OTS-39-00030-00

OTS-69-00010-00

OTS-32-00008-00

OTS-62-00005-00

IFU-03-004

FCC Declaration of Conformity

Manufacturer

Serial number

Consult operating instructions

Bluetooth


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CP

iQ

Don

Doff

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Battery

CertifiedProsthetist

Adaptive Vacuum Device

Put on

Take off

European Conformity Mark

Included w/iQ Available/Sold SeparatelyQtyPart Number

YES

YES

YES

YES

YES

YES

YES

YES

YES

YES

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1

1

1

4

1

1

1

1

1

NO

YES

YES

YES

YES

YES

YES

YES

YES

YES

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• 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.

Warnings / Safety Precautions


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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 UseFreedom iQ Vacuum is intended for use by individuals withlowerlimbamputationswhowouldbenefitfromimproved socket environment and physical connection to their prosthesis.

IndicationsFreedom iQ Vacuum is indicated for use as a component in a prosthetic leg for individuals with lower limbdeficiencyincluding:• Persons or Individuals with unilateral or bilateral

transtibial amputations • Individuals with congenital limb loss below the knee

QualificationsFreedom iQ Vacuum should only be integratedin the prosthesis by a trained O&P professional.

ProductSpecificationsPhysical PropertiesNo weight limit for users of all activity levels.AverageProductWeight:271g/0.6lbsBuildHeight:0”forstandardPylonSuitableforambulatorylevel:K2-K4iQ Vacuum is tested and compliant with the following standards: • IEC/EN60601-1

EnvironmentalSpecifications• OperatingTemperature:0to45°C/32to113°F • StorageTemperature:-25to+70°C/-13to158°F • HumidityRange:0–100%• AltitudeRange:0-3,350m(0-11,000ft)• Waterresistance:ratedtoIP67 - iQ Vacuum should be powered off or put into

Water Mode if submersion is anticipated. - iQ Vacuum is safe for occasional submersion in

freshwaterupto1m(3ft)forupto30minutes.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.

Product Description

SetupiQ 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 thefootdependsuponthetopprofileoftheprostheticfootchosen.

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 fitsnugglyagainstthepylonandrubbershim.Positionthe 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 clampboltsandtightenwithatorquewrenchto5Nm(4ft-lb).Checkthattheunitisheldfirmlyanddoesnotslip.You may have to choose a different 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 sideofprosthesisforabetterfit.

Maintenance & CleaningiQ 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.

TheexternalfilteroftheiQVacuumshouldbereplacedevery 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.


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Vacuum Connection and Filter With iQ Vacuum securely fastened to the prosthesis, attachthefilterassemblywith1/8”tubingtothesocketbarbfitting,whichshouldbeasclosetothebottom of the socket as practical.

Connectthe1/16”tubingtothefilterassemblyandrouteit 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.

Basic Operations User PanelTo 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.

Turn OnDon the prosthesis prior to turning on. Press and hold the center button until the indicator light turns green, then release.Aseriesofgreenflashesfollowtoreportthebattery charge. 4GreenFlashes=75-100% 3GreenFlashes=50-75% 2GreenFlashes=25-50% 1GreenFlash =0-25%

Theamberlightturnsonafterbatteryreportflashes,and indicates that the pump is pulling vacuum to donning level.

• Power / Function Button

• Battery / Function Indicator

Filter Assembly •

Cut Vacuum Line •

Turn OffPress and hold the center button until the indicator light turnsgreen,thenrelease.Agreenflashfollowedbyanamber LED will indicate the unit is off. The amber LED remains lit while a relief valve is held open to aid in doffingtheprosthesis.

Battery Life2-3 days under normal operating conditions.

Battery LevelAquickpressofthebutton(whileonoroff)willdisplaythe battery level according to the pattern above.

ResetWhile 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 aflashingredlightwillindicatethatthefirmwareisresetting. If you decide not to reset, simply continue pressing the button until the amber light turns off. WARNING:Aresetwilleraseallmemoryandrestorefactory settings.

Warning IndicatorsThe indicator will glow amber steadily under the followingconditions: • Battery Low • Socket Seal Leak • Blockage of Vacuum • Unable to Reach Donning Vacuum Level

Critical Error IndicatorsTheindicatorwillflashredquicklyfor10secondsandthe unit will turn off automatically under the following conditions: • Battery Too Low to Continue • Unresolved Socket Seal Leak • Continuing Blockage of Vacuum

Normal FunctioniQ 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 patient. If it is unable to achieve the donning level in a short time, the warning indicator will illuminate amber. Check for leaks in the


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socket or tubing connections and don the prosthesis again.

Battery Charging Tochargethebattery: • 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 iQ Vacuum App For Prosthetists(iQVacApp)DashboardAfter 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 LevelsWhile iQ Vacuum is fully automatic, the amount of vacuum targeted at different 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 patient. 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 SetupTo use Step Detection Setup, have the patient walk continuously. Each time that the device observes a step,thegraycircleinthemiddlewillflashgreenand there will be an audible beep. Make sure the sound on your mobile device is turned on and the volumeisup.Thereshouldbeoneflash/beepforeach step you observe. Ignore starting, stopping and turning steps. After watching the user for several steps, tap the control on the screen that reflectsifthedevicedetected:“TooFew”,“TooMany” 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 patient at a variety of cadences.

Adjust Target Step RatesThe vacuum level target increases with increasing


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activitylevels(Low,Medium,High)asdefinedbythetarget 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 patient does not achieve the higher activity levels.

Outcomes and Engineering ReportsiQ 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. Thereportonscreenmaybeemailed,filetransferred, or printed depending on the mobile OS you are using.

An Engineering Report can be created in .CSV format by selecting Controls>Device>Engineering Report. The Engineering Report offers more detailed session data for the last 100 sessions of use.

Freedom iQ Vacuum App (iQVacApp)forPatientsInteractionsThe iQ Vac App for patients allows the patient to interact withiQVacuumonamorelimitedbasis: • View Battery Charge Level • View Current Activity Level • View Seal Quality •ViewStepCounts(Currentsessionandlifetime) • 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:UserwillnotbeabletoconnectviatheiQVacApp when iQ Vacuum is simultaneously connected to another mobile device.

WARNING:Usersshouldnotwatchthescreenontheirmobile device while walking.

FEATURES AND OPTIONS The iQ Vac App allows patients to customize their interactions with the iQ Vacuum.

Water Mode Patients 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 patient 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:Usersshouldensurethatthereisnowater intrusion into the socket of their prosthesis


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before turning the device back on. Water inside the socket will be pumped through the device and may cause damage.Stop on Leak The patient may toggle the Stop on Leak feature on or off from the Settings menu (Controls>Settings>Misc).Whiletoggledon,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 patient desires to continue wearing the prosthesis in spite of a leak, toggling Stop on Leak off will cause the iQ Vacuum to alternate between pump and rest, instead of turning off.Vent on Power Off The Vent on Power Off feature is available to patients through the Settings menu (Controls>Settings>Misc).TheVentonPowerOfffeature enables the user to set a time in seconds thattheiQVacuumshouldventvacuum(allowairtocomein)eachtimeitispowereddown,helpingpatients 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. • TaptheIDnumber(orcustomname)oftheiQ

Vacuum to connect.

Note:WhenconnectingtoiQVacuumwithamobiledeviceforthefirsttime,theiQVacAppwillinstructthe user to hold their mobile device very close to the iQ Vacuum unit to ensure this is an authorized wireless request.

DisconnectingWhen you are done interacting with iQ Vacuum, select Controls>Disconnect to disconnect the Bluetooth connection to iQ Vacuum. This will conserve battery power.

Emissions Compliance Electromagnetic Environment— Test Guidance

RF Emissions EN 55011/ Group 1 iQ Vacuum uses RF energy CISPR 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/ Class B iQ Vacuum is suitable for use CISPR 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

WarrantyPurchase of the iQ Vacuum includes a 24-month warranty covering all manufacturer defects effective 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 toll-free at 1.888.818.6777

Electromagnetic Precautions The Freedom iQ Vacuum™ needs special precautions regardingelectromagneticcompatibility(EMC).SpecificallyitneedstobeinstalledandputintoserviceaccordingtotheEMCinformationprovidedasfollows:

• This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:(1)thisdevicemaynotcauseharmfulinterference,and(2)thisdevicemustacceptanyinterference received, including interference that may cause undesired operation.

GuidanceandManufacturer’sDeclaration–Electromagnetic EmissionsiQ Vacuum is intended for use in the electromagnetic environmentspecifiedbelow.Thecustomeroruserof iQ Vacuum should assure that it is used in such an environment.


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B

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

Quicktap(lessthan1/2second)to report battery level when On or Off

Quicktap(lessthan1/2second)to restart donning mode if failed

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2

3

iQ Vacuum Product Detail

A

C

D

IFU-03-004 Information For Use, Rev A

Connect with us

Global Headquarters 3 MorganIrvine, CA 92618 tollfree:888-818-6777phone:949-672-0032fax:949-672-0084www.freedom-innovations.com

#freedominnovations

©2019 Freedom Innovations, LLC. All rights reserved. iQ Vacuum is a trademark of Freedom Innovations, LLC.

CE ConformityTheFreedomiQVacuumistestedandcertifiedto comply with the MDD93/42/EEC(EN55011ClassBandIEC60601-1andIEC60601-1-3),STSIEN300-328underR&TTE Directive 1999/5/EC and, ISO10328. The device complies with Part 15 of the FCC Rules and carries the CE mark.

Authorized RepresentativeAdvena Ltd.PureOfficesPlato Close, Warwick, CV 34 6 WEUnitedKingdom

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