Arjo Huntleigh Dopplex Ability User manual

Dopplex®Ability Auto ABI Monitor
INSTRUCTIONS FOR USE
Dopplex®Ability
771438EN-14 06/2022

Table of Contents
1. Safety ...................................................................................................4
1.1 Warnings................................................................................................. 4
1.2 Residual Risks ....................................................................................... 5
1.3 Patient Applied Parts............................................................................. 5
1.4 Service Life............................................................................................. 5
2. Infection Control..................................................................................6
3. Intended Use........................................................................................6
3.1 User Requirements................................................................................ 6
4. Limitations of Use / Contraindications..............................................7
4.1 Model Description.................................................................................. 8
5. Preliminary Checks .............................................................................9
6. Initial Set-up.........................................................................................10
6.1 Battery Re-Connection *........................................................................ 10
6.2 Setting the Language ............................................................................ 11
6.3 Battery Conditioning *........................................................................... 11
7. Use Environment ................................................................................12
8. Line (Mains) Power Operation............................................................13
8.1 Fuses....................................................................................................... 13
9. Battery Operation *..............................................................................14
10.ProductIdentication .........................................................................15
10.1 Front Panel ............................................................................................. 15
10.2 Rear Panel .............................................................................................. 15
10.3 Base ........................................................................................................ 16
10.4 Product Labelling................................................................................... 16
11.System Connection.............................................................................18
11.1 USB Port ................................................................................................. 18
12.Operation ............................................................................................19
12.1 Getting Started ...................................................................................... 19
12.2 Loading Paper *...................................................................................... 20
12.3 User Settings.......................................................................................... 21
12.3.1 System Settings ..................................................................................................... 21
12.4 Making a Measurement ......................................................................... 25
12.4.1 Patient Preparation................................................................................................. 25
12.4.2 Setting Patient Type .............................................................................................. 26
12.4.3 FittingtheCu󰀨s ...................................................................................................... 26
12.4.4 Performing the test ................................................................................................. 30
12.4.5 Viewing the results ................................................................................................ 30
12.4.6 Example reports ..................................................................................................... 31

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12.4.7 Paper Low Indication * ........................................................................................... 32
12.4.8 Report Storage Guidance * .................................................................................... 32
12.5 Switching the Unit into Standby........................................................... 32
13.Troubleshooting ..................................................................................33
13.1 Error Messages...................................................................................... 34
13.2 Cu󰀨LeakTest ........................................................................................ 36
13.3 Guidance for Reliable Performance..................................................... 37
14.Care and Cleaning..............................................................................38
14.1 General Care........................................................................................... 38
14.2 CleaningandDisinfectingCu󰀨sandTubing....................................... 39
14.3 Cleaning and Disinfecting the Ability Unit .......................................... 40
15.Maintenance.........................................................................................41
16.Accessories .........................................................................................42
16.1 Carry bag ................................................................................................ 42
16.2 Roll Stand ............................................................................................... 43
17.Specications .....................................................................................46
17.1 EquipmentClassication..................................................................... 46
17.2 Performance........................................................................................... 46
17.3 General ................................................................................................... 47
17.4 Environmental........................................................................................ 47
17.5 Standards Compliance.......................................................................... 47
17.6 Batteries ................................................................................................. 48
17.7 Accessories ........................................................................................... 48
18.Electromagnetic Compatibility...........................................................49
18.1 Electrostatic Discharge......................................................................... 52
19.End of Life Disposal............................................................................53
20.Warranty & Service..............................................................................54
Note
As our policy is one of continuous improvement, we reserve the right to
modify designs without prior notice.

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1. Safety
Before using this equipment, please study this manual carefully and
familiarise yourself with the controls, display features and
operation. Ensure that each user fully understands the safety and
operation of the unit, as mis-use may cause harm to the user or
patient, or damage to the product.
Please keep these Instructions for Use to hand for future reference.
Symbols
WARNING: .....
Indicates the possibility of death or serious injury
CAUTION: ......
Indicates the possibility of personal injury or material damage.
Attention, consult accompanying documents / Instructions for Use
1.1 Warnings
WARNING: A possible explosion hazard exists if used in the presence of
ammableanaesthetics.
WARNING: Do not operate the unit from the mains supply if the mains
cable is damaged.
WARNING: Do not immerse any portion of the unit in water or other
liquids.
WARNING: If this product is connected to another item of electrical
equipment, it is important that the system is fully compliant with
IEC60601-1:2005.
WARNING:Donotapplycu󰀨directlytonon-intactskin.Ifawoundis
present, ensure a suitable wound dressing is applied, followed by an
infection control barrier sleeve.
WARNING:Whenconguringthesystem,considerandminimisethe
risk of persons tripping over the tubing and electrical cables.
WARNING:Thisequipmentmustnotbemodied.

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1.2 Residual Risks
Residual risks are those risks that require a warning or caution to be
enteredintothismanual.Theyareidentiedbytheproximityofthis
symbol.
1.3 Patient Applied Parts
AsdenedinIEC60601-1:2005,thepatientappliedpartsofthedopplexAbillityarethe
fourdualchambercu󰀨s.
1.4 Service Life
Thishasbeendenedastheminimumtimeperiodduringwhichthedeviceisexpected
to remain safe and suitable to meet its intended use, and all risk control measures
remaine󰀨ective.
HuntleighHealthcareLtd’scommitmentisthattheexpectedservicelifeforthisDevice
hasbeendenedas7years.

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2. Infection Control
WARNING:Beforettingcu󰀨stothepatient,evaluatethecross
contamination risk. For medium/high risk situations, where the patient
has a known infection or skin is not intact, use an infection control
barrier sleeve with aseptic technique.
Infectioncontrolbarriersleevesareavailableasanaccessory,PartNo.ACC-VAS-016.
RefertoSection12.4forsleeveandcu󰀨ttinginstructions.
Refer to Section 14.2 for care and cleaning instructions.
WARNING: Infection control barrier sleeves are single use devices and
must not be re-used. They must be disposed of as infectious clinical
waste.
3. Intended Use
Itisintendedtobeusedonallpatientsconsideredtobeatriskofhaving,ordeveloping
peripheralarterialdisease(PAD).
DopplexAbilityisintendedfortherapidmeasurementofankle-brachialpressureindex
(ABPI)orankle-brachialindex(ABI)inadultsandpulsevolumerecording(PVR)/
volumeplethysmography.
Abilityissuitableforuseinwoundcareassessment,forassessingsymptomaticPAD,
andasascreeningdeviceforPAD.
Itmayalsobeusedonpatientswithvenousorarterialulcerspriortotheapplicationof
compression therapy.
DopplexAbilitycanbeusedonpatientswithunilaterallowerlimbamputation.
3.1 User Requirements
DopplexAbilityisintendedforuseonlybyasuitablyqualiedhealthcareprofessional.
If an ABI test is undertaken by a Healthcare Support Worker, then patient selection and
assessmentofresultsmustbeperformedbyaqualiedclinicianinconjunctionwitha
clinical assessment.
Itisrecommendedthatallusersfamiliarisethemselveswiththeinformationprovidedin
this user manual and in the enclosed Training Pack before using this product.

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4. Limitations of Use / Contraindications
WARNING: Dopplex Ability is not intended to be used in the following
patient conditions:
• a suspected or present Deep Vein Thrombosis (DVT)
• severe congestive cardiac failure or similar condition
• gangrene
• recent skin graft
• untreated leg or foot wounds
• dermatitis
WARNING: Systolic pressures are displayed for information only, and
should not be used to form a clinical diagnosis.
CAUTION: Dopplex Ability is not intended to be used in the following patient
conditions:
• cellulitis
• management of pulmonary hypertension
• patientswhocannotremainstillorlieat
• patients under 18 years of age
• Severe hypertension
• Parkinsons Disease
• Severe PAD (ankle systolic pressure less than 60 mmHg)
• Lymphoedema
• Very oedematous limbs
• Any condition that prevents both arm pressures being measured e.g.
mastectomy
CAUTION: Dopplex Ability provides just one indicator of vascular condition.
This should be used as part of an holistic approach to leg ulcer assessment
together with other factors in forming the clinical diagnosis. The results
from dopplex Ability must not be solely relied upon. A complete vascular
assessment including clinical history and symptoms must be made before
taking appropriate action.
CAUTION: If the results from the dopplex Ability do not match the clinical
history and symptoms of the patient, then further tests, e.g. Doppler waveform
analysis, are recommended.
CAUTION: False high ABI results may occur in diabetic patients when the leg
cu󰀨isunabletocompresscalcieddistalarteriesontheanklee󰀨ectively.
CAUTION:Ensureallcu󰀨sarettedcorrectlyandalignedonlimbsaccording
totheinstructions.Measurementerrormayoccurifcu󰀨sarettedincorrectly.
CAUTION:TheABIClassicationthresholds,whichareadjustableviathe
frontpanelfunctionbuttons,shouldonlybeadjustedbyasuitablyqualied
clinician.

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CAUTION:AlwaysobserveABIvalue,notonlyclassication,asmarginal
results could be overlooked.
CAUTION: Do not sterilise the product or its accessories. The product will be
damaged, and there is a risk of patient and user harm.
CAUTION: If using the dopplex Ability roll stand, ensure the unit is properly
locked in place, otherwise it could fall, and cause personal injury. age.
4.1 Model Description
REF Product Features
DA100 DopplexAbility
DA100PB DopplexAbilitywithintegralprinterandbattery

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5. Preliminary Checks
Contents (supplied with each system)
Item Item Item
1 x dopplex Ability Allen Key 1 x Training pack:
(TrainingCD,
InstructionsforUseCD,
Quick Reference Guide,
FAQ’s,
PVR Application,
BatteryLeaet,
RegistrationLeaet)
4xAdultDualChamber
Cu󰀨swithColourCoded
tubes
2 x Rolls Printer Paper*
(1xplain,1xlabel)
1 x Box Infection Control
BarrierSleeves
1 x Mains Cable
Delivery Inspection
HuntleighHealthcareLtdtakeseveryprecautiontoensurethatgoodsreachyouin
perfectcondition.However,accidentaldamagecanoccurintransitandstorage.For
thisreasonwerecommendthatathoroughvisualinspectionismadeimmediatelythe
unitisreceived.Shouldanydamagebeevidentoranypartsmissing,ensurethat
Huntleigh Healthcare Ltd is informed as soon as possible.
Storage
Shouldtheunitnotberequiredforimmediateuse,itshouldbere-sealedintoits
originalpackingaftercarryingouttheinitialdeliveryinspection,andstoredunder
coveredconditionsatatemperaturebetween-20°Cto+50°C,andrelativehumidityof
10% to 90% non-condensing.
Ifitisnecessarytostoretheunitafteraperiodofuse,itisadvisabletorstdisconnect
thebattery*(removebatterycoverasdescribedbelowanddisconnectbattery–DO
NOTAPPLYSTRAINTOTHEWIRES),andremovepressurefromtheprinterrollerby
openingtheprinterlidslightly.Thenfollowtheabovestorageinstructions.
Note
Expected battery lifetime depends on care. With correct care, frequent
charging and storage at room temperature, the battery lifecan be prolonged.
If the unit is stored in high ambient temperatures and/or for an extended period
without re-charging, it is likely that battery capacity will be degraded.
Replace the battery every two years.
For long term storage, the internal Real Time Clock backup battery should also be
removed.Refertotheservicemanualfordetails.
* Depending on model

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6. Initial Set-up
6.1 Battery Re-Connection *
Note
The dopplex Ability is supplied with the internal battery disconnected. To re-
connect the battery, please see instructions below.
1. Inverttheunitandremovethebatterycoverbyremovingthesecuringscrew
 usingtheallenkeyprovided.
2. Lift the battery out, and connect the battery to the unit.
3. Replacethebattery.Re-tthebatterycoverandreplacethesecuring 
 screwwiththeallenkeyprovided.DO NOT OVERTIGHTEN!
* Depending on model

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4. Connecttheunittothemainssupply(1)andswitchitonbypressing 
 theOn/Standbybutton (2).
1
V1.2
2
6.2 Setting the Language
Whenswitchedonforthersttime,theoperatinglanguagemustbeselected.
The language selection screen will be displayed.
English
Deutsch
Francais
Italiano
CONFIRM
English
SET LANGUAGE
Press tohighlighttherequiredlanguage.Press to Select.
6.3 Battery Conditioning *
Immediately after the language has been selected, the battery conditioning screen will
be displayed.
Battery Conditioning
(Do Not Disconnect From Mains)
Note: The battery must be conditioned before
theunitisrstused.Ifthebatteryisnot
conditioned, battery operation will be unreliable.
To start battery conditioning, press the centre softkey.
Whenconditioningiscomplete,theunitwillswitcho󰀨
automatically. It can then be switched on and used
from mains supply or battery.
Note: Battery conditioning can take up to 10 hours to complete.
* Depending on model

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7. Use Environment
DopplexAbilityissuitableforuseinhospital,primarycareandcommunitysettings.It
mustnotbeusedoutdoors,orinanyenvironmentwhereitmaycomeintocontactwith
water.
Thisequipmentisnotsuitablefordomesticuse.
Acouch,orsimilarlevelsupportsurfaceisrequiredforthepatienttolieon,andthe
mainunitrequiresatableorsimilarforsupport.Alternatively,arollstandisavailable
as an accessory, part number ACC-VAS-013.
WARNING: It is important for safety that the use environment is well-lit
to reduce the risk of persons tripping over the cables and tubes. Use is
not recommended in areas that are used as access walkways.
Useinstrongsunlightshouldbeavoidedasdisplayvisibilityisgreatlyreduced.
The patient support surface must be wide enough for the patient to be able to allow
their arms to lie comfortably at their sides. The patient’s arms must be completely
relaxed during the test and not pulled tight against the body. The couch should be
separatedfromadjacentwallsetc.aspressureonthearmsorcu󰀨smustbeavoided.
Thepatientsheelsmustbesupportedonthecouchandnotbeallowedtooverhang
the end.
Thetestenvironmentshouldbereasonablyquiet,asexcessiveambientnoisemay
preventthepatientfromrelaxing;animportanttestrequirement.

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8. Line (Mains) Power Operation
DopplexAbilityissuppliedwithaplug-inmainslead,ttedwitha3pinmainsplug.The
coresusetheEuropeancolourcode:
BROWN LIVE
BLUE NEUTRAL
GREEN/YELLOW FUNCTIONALEARTH
Ifitbecomesnecessarytotanewmainsplugtakecarethatthewireshavecorrect
lengths,sothatintheeventofextremestrain,theearthwirewillbethelasttobreak.
Make sure that the cable clamp secures the outer sheathing so that there is no direct
strainonanyindividualwiresattheterminals.
Wheretheplugisfused,a5Afuseshouldbetted.
Connect the power cable to the line power socket. If a good, reliable earth is not
availableoperatethedopplexAbilityfromitsinternalbatterypack*.
Note: To isolate the dopplex Ability from the mains or line supply, disconnect
the power cable from the mains inlet at the rear of the unit. Ensure this is fully
accessible at all times.
* Depending on model
8.1 Fuses
Internalfusesarettedinboththeliveandneutrallines.Correctlyratedfusesmustbe
ttedasbelow:-
T1AH 250VAC
Fusesmustonlybereplacedbyasuitablyqualiedtechnician.

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9. Battery Operation *
Theinternalbattery,whenfullycharged,providesenoughpowerforapproximatelyten
ABI measurements.
An on-screen indicator shows the state of charge at all times.
Batterychargingtakesplacewhentheunitisconnectedtotheline(mains)power.
Duringbatterycharging,thebatterysymbolllsfromlefttoright.Thetimerequiredto
fully charge a completely discharged battery is approximately two hours.
Whenthebatteryreachesacriticallylowlevelofchargesuchthatfurtheruseisnot
possible,thebatterysymbolwillappearinoutline,andwillashcontinuously.Theunit
willthenswitcho󰀨automaticallywhenthebatteryiscompletelydischarged.
If the battery is disconnected for any reason, it must be conditioned immediately after
re-connection.Refertosection12.3.1(h)forinstructions.Failuretodothiswillresultin
unreliable operation from the battery.
Power Save Functions
Whenoperatedfromtheinternalbattery,powersavefunctionsareenabled:
• Afterthreeminutesofnokeypaduse,thedisplaybacklightwillswitcho󰀨.
To switch backlight back on, simply press any of the buttons below the
display once.
• Aftertenminutesofnokeypaduse,theunitwillswitcho󰀨.Toswitch
theunitbackon,pressthepowerOn/Standbybuttonandholdforthree
seconds.
Note: Any results will be lost unless a printout has been produced.
* Depending on model

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10. ProductIdentication
10.1 Front Panel
V1.2
1
4
3
2
1On/Standbybutton
2Display
3Function Buttons
4Colour Coded Tubes
10.2 Rear Panel
1
2
3
1Mains Inlet
2PrinterCover(dependingonmodel)
3COMPortConnector(USB)

16
Instructions For Use
EN
10.3 Base
2
1
3
4
1BatteryCover
2BatteryCoverRetainingScrew
3Slide plate Mounting boss
4Air Filter
10.4 Product Labelling
Note: Product labelling should be read from a distance no greater than 0.5m.
DopplexAbilityisClassII,doubleinsulatedaccordingtothedenitionsin
BSEN60601-1:1990
Appliedparts(cu󰀨s)aretypeBFaccordingtothedenitionsinBSEN
60601-1:1990
Functional Earth PowerOn/Standby
Alternatingcurrent(AC)
Thissymbolsigniesthatthisproduct,includingitsaccessoriesandconsumables
issubjecttotheWEEE(WasteElectricalandElectronicEquipment)regulationsand
should be disposed of responsibly in accordance with local procedures.
Thissymbolsigniesthatthisproductcomplieswiththeessential
requirementsoftheMedicalDeviceDirective(93/42/EEC)-Medical
DeviceRegulation(EU/2017/745)

17
Instructions For Use
EN
WARNING: ..... Indicates the possibility of death or serious injury
CAUTION: ...... Indicates the possibility of personal injury or material
damage.
Attention, consult accompanying documents / Instructions for Use
YYYY-MM
Legal Manufacturer in association with the CE mark in Europe
ArjoHuntleigh AB, Hans Michelsensgatan 10 211 20 Malmö, Sweden
Manufactured
By:
Huntleigh Healthcare Ltd.
35 Portmanmoor Road, Cardiff, CF24 5HN, United Kingdom
T: [phone] [email protected]
www.huntleigh-diagnostics.com
Medical
Electrical
Equipment
ANSI/AAMI ES60601-1 (2005, 3rd ed.)
CAN/CSA-C22.2 No 60601-1 (2008)
UL60601-1, CAN/CSA C22.2 No 601.1
E364052
TheULmarkindicatesthatDopplexAbilitycomplies
withUnderwritersLaboratoriesrequirementsforsafety,
andissubjecttoUL’sfollowupservicesprogramwhich
veriesthatthemanufacturedproductcontinuesto
complywithUL’ssafetyrequirements.
YYYY
-MM
Use By DoNotReuse
50°C
-10°C
Temperature
Limitations
25°C
Upper Limit of Temperature
SN
Serial Number
REF
Reference Number
MD MedicalDevice DI DeviceIdentier
KeepDry Donotusehook
This way up Contents can be recycled
Returnable packaging Cardboard packaging can be recycled.
PVC
PVC FREE
DoesnotcontainPVC
LATEX
LATEX FREE
DoesnotcontainLatex
93%
LimitsofRelative
Humidity Limits of Atmospheric Pressure
Fragile
YYYY-MM
DateofManufacture
RoHS Compliant
(RoHS - Restriction of
HazardousSubstances)
IP30
Protected against ingress of solid
foreign objects >2.5mm diameter. Not
protected against ingress of water.

18
Instructions For Use
EN
11. System Connection
WARNING: These requirements must be met when a dopplex Ability is
connected to any other electrical equipment, such as a PC.
1 Non-medicalequipmentmustcomplywiththerelevantIECor  
 ISOsafetystandard.ForInformationTechnologyequipment,this 
standard is IEC950/ EN60950.
2 MedicalequipmentmustcomplywithIEC60601-1,orequivalent.
3 Theconguredsystemmustcomplywiththerequirementsof  
 IEC60601-1:2005;clause16.
4 Ifnon-medicalequipment(e.g.thePCorprinter)withenclosure 
leakage currents greater than those allowed by IEC60601-1 is to
 beusedinthepatientenvironment(within1.5mofthepatient), 
the enclosure leakage currents must be brought within the limits laid
 downbyIEC60601-1.Thismaybeachievedbyusingamedical 
 gradeisolatingtransformer.Suitabletypesareavailablevia  
Huntleigh sales agents.
5 Anyonewhoconnectsadditionalequipmenttosignalinputorsignal 
 outputpartsofthesystemisconguringamedicalsystem,andis
therefore responsible for ensuring that the system complies with the
 requirementsofIEC60601-1:2005;clause16.Ifthereisanydoubtas 
 towhetheryoursystemcomplies,consultthetechnicalservice 
 departmentoryourlocalHuntleighrepresentative.
11.1 USB Port
DopplexAbilityisttedwithastandardUSBport(seeitem3,section10.2‘RearPanel’)
forconnectiontoapersonalcomputer(PC).
Connectionstothisportshouldonlybemadebysuitablytechnicallyqualied
personnel.Fortechnicalspecicationsofthisinterface,refertosection16.3.
It is intended to be used for software upgrade purposes, and has no functionality in
normal use.
Forfurtherinformation,contacttheservicedepartmentattheaddressgiveninsection
18 of this manual.

19
Instructions For Use
EN
12. Operation
12.1 Getting Started
1. Connect to mains
supply.
V1.2
2. Press .
3. Connect colour coded
tubing
Note
Use the function buttons below the display to access and change the system
setting and patient measurement menus.
V1.2 Function Buttons

20
Instructions For Use
EN
12.2 Loading Paper *
1. Graspprinterdoorrmlyandpullgentlybackwards.
2. Insertpaperrollasshownandcloseprinterdoor.A‘click’willbeheardwhen
door is fully engaged.
3. Totearpaper,holdrmlyandtearfromoneedgetowardsthefrontoftheunit.
Note: If using label paper, ensure roll ends are smooth. If not, press end of
 rollontoaatsurface
CAUTION
Only use paper approved by Huntleigh.
Note: The printer lid is designed to detach if forced. To replace, hook the
 twolidpivotsoverthemetalrodandpressrmlydownwards.A 
positive ‘click’ will be heard as each pivot snaps into place.
Note: Standard (Plain) paper will allow approximately 55 printouts.
Label paper will allow approximately 35 printouts.
* Depending on model