Spencer SED User manual

SPENCER ITALIA SRLSPENCER ITALIA SRL – Via Provinciale n° 12
43038 Sala Baganza (PR) – Italy
CS
Návod k použití a údržbě
SED - Vyprošťovací korzet
BG
Ръководство за употреба и поддръжка
SED - Гърбодържател
EL
Εγχειρίδιο χρήσης και συντήρησης
SED - Γιλέκο απεγκλωβισμού
PT
Manual de uso e manutenção
SED - Dispositivo de extração
ES
Manual de uso y mantenimiento
SED – Dispositivo de extricación
FR
Manuel d’utilisation et d’entretien
SED - Attelle d’extraction
DE
Benutzungs- und Wartungshandbuch
SED - Rettungskorsetts
EN
Use and Maintenance Manual
SED - Extrication device
IT
Manuale d’uso e manutenzione
SED - Estricatore

2
INDICE / CONTENTS / INHALTSVERZEICHNIS / SOMMAIRE / ÍNDICE
1. MODELLI 4
2. DESTINAZIONE D’USO 4
2.1 DESTINAZIONE D’USO E BENEFICI CLINICI 4
2.2 PAZIENTI DESTINATARI 4
2.3 CRITERI DI SELEZIONE PAZIENTI 4
2.4 CONTROINDICAZIONI ED EFFETTI COLLATERALI
INDESIDERATI 4
2.5 UTILIZZATORI E INSTALLATORI 4
2.5.1 FORMAZIONE UTILIZZATORI 4
2.5.2 FORMAZIONE INSTALLATORE 4
3. STANDARD DI RIFERIMENTO 4
4. INTRODUZIONE 4
4.1 UTILIZZO DEL MANUALE 4
4.2 ETICHETTATURA E CONTROLLO TRACCIABILITÀ
DEL DISPOSITIVO 4
4.3 SIMBOLI 5
4.4 GARANZIA E ASSISTENZA 5
5. AVVERTENZE/PERICOLI 5
6. AVVERTENZE SPECIFICHE 6
7. RISCHIO RESIDUO 6
8. DATI TECNICI E COMPONENTI 6
9. MESSA IN FUNZIONE 7
10. CARATTERISTICHE FUNZIONALI 7
11. MODALITA’ D’USO 7
12. PULIZIA E MANUTENZIONE 8
12.1 PULIZIA 8
12.2 MANUTENZIONE ORDINARIA 8
12.3 REVISIONE PERIODICA 9
12.4 MANUTENZIONE STRAORDINARIA 9
12.5 TEMPO DI VITA 9
13. TABELLA GESTIONE GUASTI 9
14. ACCESSORI 9
15. RICAMBI 9
16. SMALTIMENTO 9
1. MODELS 10
2. INTENDED USE 10
2.1 INTENDED USE AND CLINICAL BENEFITS 10
2.2 TARGET PATIENTS 10
2.3 PATIENT SELECTION CRITERIA 10
2.4 CONTRAINDICATIONS AND UNWANTED SIDE EFFECTS 10
2.5 USERS AND INSTALLERS 10
2.5.1 USER TRAINING 10
2.5.2 FORMAZIONE INSTALLATORE 10
3. REFERENCE STANDARDS 10
4. INTRODUCTION 10
4.1 USING THE MANUAL 10
4.2 DEVICE LABELLING AND TRACEABILITY 10
4.3 SYMBOLS 11
4.4 WARRANTY AND SERVICE 11
5. WARNINGS/DANGERS 11
6. SPECIFIC WARNINGS 12
7. RESIDUAL RISK 12
8. TECHNICAL DATA AND COMPONENTS 12
9. COMMISSIONING 13
10. OPERATING CHARACTERISTICS 13
11. PROPER USE 13
12. CLEANING AND MAINTENANCE 14
12.1 CLEANING 14
12.2 ROUTINE MAINTENANCE 14
12.3 PERIODIC OVERHAUL 14
12.4 SPECIAL MAINTENANCE 15
12.5 LIFE SPAN 15
13. TROUBLESHOOTING TABLE 15
14. ACCESSORIES 15
15. SPARE PARTS 15
16. DISPOSAL 15
1. MODELLE 16
2. VERWENDUNGSZWECK 16
2.1 VERWENDUNGSZWECK UND KLINISCHER NUTZEN 16
2.2 ZIELPATIENTEN 16
2.3 AUSWAHLKRITERIEN FÜR PATIENTEN 16
2.4 GEGENANZEIGEN UND UNERWÜNSCHTE
NEBENWIRKUNGEN 16
2.5 ANWENDER UND TECHNIKER 16
2.5.1 ANWENDERAUSBILDUNG 16
2.5.2 AUSBILDUNG INSTALLATEUR 16
3. BEZUGSRICHTLINIEN 16
4. EINLEITUNG 16
4.1 GEBRAUCH DES HANDBUCHS 16
4.2 TYPENSCHILDER UND RÜCKVERFOLGBARKEIT
DES PRODUKTS 16
4.3 SYMBOLE 17
4.4 GARANTIE UND KUNDENDIENST 17
5. WARNUNGEN/GEFAHREN 17
6. SPEZIFISCHE HINWEISE 18
7. RESTRISIKO 18
8. TECHNISCHE DATEN UND KOMPONENTEN 18
9. INBETRIEBNAHME 19
10. ANWENDUNGSEIGENSCHAFTEN 19
11. GEBRAUCHSWEISE 19
12. REINIGUNG UND WARTUNG 20
12.1 REINIGUNG 20
12.2 ORDENTLICHE WARTUNG 20
12.3 REGELMÄSSIG REVISION 21
12.4 AUSSERORDENTLICHE WARTUNG 21
12.5 LEBENSDAUER 21
13. SCHADENSTABELLE 21
14. ZUBEHÖR 21
15. ERSATZTEILE 21
16. ENTSORGUNG 21
1. MODÈLES 22
2. UTILISATION 22
2.1 UTILISATION ET BÉNÉFICES CLINIQUES 22
2.2 PATIENTS DESTINATAIRES 22
2.3 CRITÈRES DE SÉLECTION DES PATIENTS 22
2.4 CONTRE-INDICATIONS ET EFFETS COLLATÉRAUX
INDÉSIRABLES 22
2.5 UTILISATEURS ET INSTALLATEURS 22
2.5.1 FORMATION DES UTILISATEURS 22
2.5.2 FORMATION INSTALLATEUR 22
3. STANDARD DE RÉFÉRENCE 22
4. INTRODUCTION 22
4.1 UTILISATION DU MANUEL 22
4.2 ÉTIQUETAGE ET CONTRÔLE DE LA TRAÇABILITÉ
DU DISPOSITIF 22
4.3 SYMBOLES 23
4.4 GARANTIE ET ASSISTANCE 23
5. AVERTISSEMENTS/DANGERS 23
6. AVERTISSEMENTS SPÉCIFIQUES 24
7. RISQUE RÉSIDUEL 24
8. DONNÉES TECHNIQUES ET COMPOSANTS 24
9. MISE EN SERVICE 25
10. CARACTÉRISTIQUES FONCTIONNELLES 25
11. MODALITÉS D’UTILISATION 25
12. NETTOYAGE ET ENTRETIEN 26
12.1 NETTOYAGE 26
12.2 ENTRETIEN ORDINAIRE 26
12.3 RÉVISION PÉRIODIQUE 27
12.4 ENTRETIEN EXTRAORDINAIRE 27
12.5 DURÉE DE VIE 27
13. TABLEAU DE GESTION DES INCONVÉNIENTS 27
14. ACCESSOIRES 27
15. PIÈCES DÉTACHÉES 27
16. ÉLIMINATION 27
1. MODELOS 28
2. DESTINO DE USO 28
2.1 DESTINO DE USO Y BENEFICIOS CLÍNICOS 28
2.2 PACIENTES DESTINATARIOS 28
2.3 CRITERIOS DE SELECCIÓN DE LOS PACIENTES 28
2.4 CONTRAINDICACIONES Y EFECTOS COLATERALES
NO DESEADOS 28
2.5 USUARIOS E INSTALADORES 28
2.5.1 FORMACIÓN DE LOS USUARIOS 28
2.5.2 FORMACIÓN DEL INSTALADOR 28
3. NORMAS DE REFERENCIA 28
4. INTRODUCCIÓN 28
4.1 USO DEL MANUAL 28
4.2 ETIQUETADO Y CONTROL DE SEGUIMIENTO DEL
DISPOSITIVO 28
4.3 SÍMBOLOS 29
4.4 GARANTÍA Y ASISTENCIA 29
5. ADVERTENCIAS/PELIGROS 29
6. ADVERTENCIAS ESPECÍFICAS 30
7. RIESGO RESIDUAL 30
8. DATOS TÉCNICOS Y COMPONENTES 30
9. PUESTA EN FUNCIONAMIENTO 31
10. CARACTERÍSTICAS DE FUNCIONAMIENTO 31
11. MODO DE USO 31
12. LIMPIEZA Y MANTENIMIENTO 32
12.1 LIMPIEZA 32
12.2 MANTENIMIENTO ORDINARIO 32
12.3 REVISIÓN PERIÓDICA 32
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1. MODELS
The following basic models may be subject to implementation or change without notice.
• SED
• SED XS
2. INTENDED USE
2.1 INTENDED USE AND CLINICAL BENEFITS
Theextricationdeviceisafirstaidapparatustobeusedfortheextractionofatraumatisedpatientfromavehicle.
Itmustbeusedaftertheapplicationofthecervicalcollartomaintainimmobilisationandhead-torsoalignment.
2.2 TARGET PATIENTS
Therearenoparticularindicationsrelatedtothepatientgroup.
Theproductconfigurationisabletoaccommodateanysubjectaslongashe/sheiswithinthemaximumcapacityandwithinthelimitsofthesizeofthedevice.
2.3 PATIENT SELECTION CRITERIA
Thepatientsexpectedaretypicallyindividualswhorequireextractionfromtheplacewheretheyarestuck.
Thetypicalsituationiscaraccidents.
Beforeextractionassistedbytheuseofthedevice,thepatientmustbeimmobilisedwithacervicalcollartopreventanyaggravationofcervicalinjuries.
2.4 CONTRAINDICATIONS AND UNWANTED SIDE EFFECTS
Noparticularcontraindicationsorsideeffectsareknownwithrelationtouseofthedevice,aslongasitisusedinaccordancewiththeusermanual.
2.5 USERS AND INSTALLERS
Theintendedusersarerescueworkerswithin-depthknowledgerelatedtotheimmobilisationandhandlingofpeoplesufferingfromroadtrafficinjuries,spinalinjuriesand
crushinjuries.
• Personneltrainedforuseofthedevicemustalsohavetraininginmanagingliftingandhandlingsuspendedloadswithpeople.
Thesedevicesarenotintendedforlaypeople.
Theextricationdeviceisanapparatusintendedforprofessionaluseonly.Donotallowuntrainedpersonstohelpwhileusingtheproduct,astheymaycauseinjuryto
themselvesorothers.
Despiteallefforts,laboratorytests,trials,andinstructionsforuse,standardsdonotalwaysreproducepractice,sotheresultsobtainedunderactualconditionsofproduct
useinthenaturalenvironmentmaysometimesdiffersignificantly.
Thebestinstructionsarethecontinuouspracticeofuseunderthesupervisionofcompetentandtrainedpersonnel.
Operatorsusingthedeviceshouldbephysicallyabletousethedeviceandhavegoodmusclecoordination,aswellasstrongback,arms,andlegs,shoulditbenecessarytolift
and/orsupportthedeviceandthepatient.Operators’abilitymustbeassessedbeforethedefinitionofrolesinuseofthestretcher.
Operators must be able to provide the necessary patient care.
2.5.1 USER TRAINING
• Regardlessofyourlevelofexperiencewithsimilardevicesinthepast,youshouldcarefullyreadandunderstandthecontentsofthismanualbeforeinstalling,operating,or
servicingthisproduct.Incaseofanyquestions,pleasecontactSpencerItaliaS.r.l.forthenecessaryclarifications.
• Operatorsmustalsobetrainedtoperformextricationmanoeuvressoastopreventaggravationofspinalinjuriesorpossiblycompromisedorgans.
• Theproductmustbeusedonlybypersonneltrainedintheuseofthisproductandnotonothersimilarproducts.
• Thesuitabilityoftheusersforuseofthisproductcanbeattestedbythetrainingregistration,inwhichtrainedpersons,trainers,dateandplacearespecified.Thisdocumenta-
tionmustbekeptforatleast10yearsaftertheendoftheproduct’slifeandmustbemadeavailabletothecompetentauthoritiesand/ortheManufacturerwhenrequested.
Intheabsenceofsuchdocumentation,therelevantbodieswillapplyanyforeseensanctions.
• Theproductmustbeputintouseonlybypersonneltrainedintheuseofthisproductandnotonothersimilarproducts.
Note: Spencer Italia S.r.l. is always available for training courses.
2.5.2 FORMAZIONE INSTALLATORE
Installationisnotrequired.
3. REFERENCE STANDARDS
AsDistributororEnd-Useroftheproductsmanufacturedand/ormarketedbySpencerItaliaS.r.l.,usersarestrictlyrequiredtobefamiliarwiththelegalprovisionsinforcein
thecountryofdestinationofthegoods,applicabletothedevicestobesupplied(includingregulationsrelatingtotechnicalspecificationsand/orsafetyrequirements)and,
therefore,tounderstandtherequirementsnecessarytoensurecomplianceoftheproductsthemselveswithalllegalrequirementsoftheterritory.
REFERENCE DOCUMENT TITLE
EU Regulation 2017/745 EU Regulation on Medical Devices
4. INTRODUCTION
4.1 USING THE MANUAL
Thepurposeofthismanualistoprovidehealthcareprofessionalswiththeinformationnecessaryforsafeandappropriateuseandmaintenanceofthedevice.
Note: The Manual is an integral part of the device and therefore it must be kept for the entire life of the device and must accompany it in any changes of use or ownership. If any
instructions for use for products other than the one received are present, please contact the Manufacturer immediately before use.
SpencerproductsUserManualscanbedownloadedfromthesitehttp://support.spencer.itorbycontactingtheManufacturer.Exceptionsarethoseitemswhoseessentiality
andreasonableandpredictableusearesuchthatitisnotnecessarytodrawupinstructions,inadditiontothefollowingwarningsandindicationsonthelabel.
Regardless ofyour levelof experiencewith similardevices inthe past,it isadvisable tocarefullyreadandunderstandthecontentsof thismanual beforeinstalling,
operating,orservicingthisproduct.
4.2 DEVICE LABELLING AND TRACEABILITY
Eachdeviceisprovidedwithalabel,placedonthedeviceitselfand/oronthepackaging,whichcontainstheManufacturer’sidentificationdata,product,CEmarking,serial
number(SN)orlotnumber(LOT).Thismustneverberemovedorcovered.
Intheeventofdamageorremoval,requestaduplicatefromtheManufacturer,orelsethewarrantywillbevoidasthedevicecannolongerbetraced.
If the assigned Lot/SN cannot be traced, the device must be reconditioned, provided only under the responsibility of the manufacturer.
EURegulation2017/754requiresmanufacturersanddistributorsofmedicaldevicestokeeptrackoftheirlocation.Ifthedeviceisinalocationotherthantheaddresstowhich
itwasshippedorsold,orifitwasdonated,lost,stolen,exportedordestroyed,permanentlyremovedfromuse,orifthedevicewasnotdelivereddirectlyfromSpencerItalia
S.r.l.,pleaseregisterthedeviceathttp://service.spencer.it,orinformCustomerService(see§4.4).

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4.3 SYMBOLS
Symbol Meaning Symbol Meaning
DeviceincompliancewithEURegulation2017/745
Danger–Indicatesahazardoussituationthatmayresultinasituation
directlyrelatedtoseriousinjuryordeath.
Medical device Seetheusermanual
Manufacturer Lot number
Date of manufacture Product code
UniqueDeviceIdentifier Caution:FederalLawrestrictsthisdevicetosalebyorontheorderofa
licensedpractitioner(onlyforUSAMarket)
4.4 WARRANTY AND SERVICE
SpencerItaliaS.r.l.guaranteesthatproductsarefreefromdefectsforaperiodofone year from the date of purchase.
Forinformationoncorrectinterpretationoftheuse,maintenance,installationorreturninstructions,pleasecontacttheSpencerCustomerAssistanceattel.+390521541154,
fax+390521541222,e-mail[e-mail]
Tofacilitateservice,alwaysindicatethelotnumber(LOT)orserialnumber(SN)onthelabelattachedtothepackageordeviceitself.
Warranty and service conditions are available at http://support.spencer.it
Note: Record and keep with these instructions: lot (LOT) or serial number (SN), if present, place and date of purchase, date of first use, date of checks, user name and comments.
5. WARNINGS/DANGERS
Warnings,dangers,notes,andotherimportantsafetyinformationareprovidedinthissectionandareclearlyvisiblethroughoutthemanual.
Atleastevery6months,itisimportanttocheckforupdatedinstructionsandanychangesinvolvingyourproduct.Thisinformationisfreelyavailableonthewebsitewww.
spencer.itonthespecificproductpage.
Product features
UseoftheproductforanypurposeotherthanthatdescribedintheUserManualisprohibited.
• Beforeeachuse,alwayschecktheconditionsoftheproduct,asspecifiedintheUserManual.Intheeventoffaults/damagethatcouldcompromiseitsfunctionality/safety,
immediatelyremoveitfromserviceandcontacttheManufacturer.
• Iftheproductisfoundtobemalfunctioning,immediatelyuseasimilardevicetoensurecontinuityofongoingoperations.Non-compliantdevicesmustbetakenoutof
service.
• Theproductmustnotbetamperedwithormodifiedwithoutthemanufacturer’sauthorisation(modification,tweaking,additions,repair,useofnon-approvedaccessories),
astheymayconstituteimminentdangerofinjurytopersonsandmaterialdamage.Shouldtheseoperationsbeperformed,wedeclineanyresponsibilityforincorrectope-
rationoranydamagecausedbytheproductitself;moreover,theCEmarkingandtheproductwarrantyshallbenullandvoid.
• Whenusingthedevices,positionandadjusttheminsuchawaythattheydonothinderoperatorworksortheuseofanyotherequipment.
• Besuretotakeeveryprecautiontoavoidhazardsfromcontactwithbloodorbodysecretions,ifapplicable.
• Avoidcontactwithsharporabrasiveobjects.
• ThetimesandmethodsofsuchshallbeagreeduponbetweenthecustomerandourSalesOffices.
• Operatingtemperature:from-5°Cto+50°C..
Storage
• Theproductmustnotbeexposedorcomeintocontactwiththermalsourcesofcombustionorflammableagents,butmustinsteadbestoredinadry,coolplace,away
fromlightandsun.
• Donotstoretheproductunderothermoreorlessheavymaterialsthatmaydamagethestructureoftheproduct.
• Storeandtransporttheproductwithitsoriginalpackaging,otherwisethewarrantyshallbeinvalidated.
• Storagetemperature:-10°Cto+60°C.
Regulatory requirements:
AsDistributororEnd-Useroftheproductsmanufacturedand/ormarketedbySpencerItaliaS.r.l.,usersarestrictlyrequiredtobefamiliarwiththelegalprovisionsinforcein
thecountryofdestinationofthegoods,applicabletothedevicestobesupplied(includingregulationsrelatingtotechnicalspecificationsand/orsafetyrequirements)and,
therefore,tounderstandtherequirementsnecessarytoensurecomplianceoftheproductsthemselveswithalllegalrequirementsoftheterritory..
• PromptlyandindetailnotifySpencerItaliaS.r.l.(alreadyinthequotationrequestphase)aboutpossiblefulfilmentsbytheManufacturernecessaryforthecomplianceof
productswithspecificlegalrequirementsoftheterritory(includingthosederivingfromregulationsand/orregulatoryprovisionsofanothernature).
• Actwithduecareanddiligencetohelpensurecompliancewiththegeneralsafetyrequirementsofthedevicesplacedonthemarket,providingend-userswithalltheinfor-
mationnecessarytocarryoutperiodicrevisionsonthesupplieddevices,exactlyasindicatedintheUserManual.
• Participate in safety checks on products placedonthemarket,transmittinginformationregardingproductriskstotheManufactureraswellastotheCompetentAuthorities
fortheirrespectiveactions. 
• Withoutprejudicetotheabove,theDistributororEnd-Usershallassumewiderliabilityrelatedtonon-compliancewithnon-fulfilmentoftheabove-mentionedobligations,
withconsequentobligationtoindemnifyand/orholdSpencerItaliaS.r.l.harmlessfromanypossibleinjuriouseffect.
• WithreferencetoEURegulation2017/745,pleasenotethatpublicorprivateoperatorswho,whenexercisingtheiractivity,detectanincidentinvolvingamedicalproduct
arerequiredtonotifytheMinistryofHealth,withinthetermsandinthemannerestablishedbyoneormoreministerialdecrees,andnotifytheManufacturer.Publicor
privatehealthcareprofessionalsarerequiredtonotifytheManufacturerofanyotherincidentthatmayallowtheadoptionofmeasurestoensuretheprotectionandhealth
of patients and users.
General warnings for medical devices
Usermustcarefullyreadthefollowinginadditiontothegeneralwarnings.
• Theapplicationofthedeviceshouldnotlastlongerthanthetimerequiredforfirstaidoperationsandsubsequenttransporttothenearestrescuepoint.
• Qualifiedpersonnelandatleasttwooperatorsmustbepresentduringuseofthedevice.
• Donotuseifthedeviceorpartsofitarepunctured,torn,frayed,orexcessivelyworn.
• Followtheinternalproceduresandprotocolsapprovedbyyourorganisation.
• Donotalterormodifythedevicearbitrarily,asdoingsocouldresultinunpredictableoperationanddamagetothepatientorrescuersandshallvoidthemanufacturer’s
warrantyandreleasethemanufacturerfromallliability.
• Disinfectionoperationsmustbecarriedoutinaccordancewiththevalidatedcycleparameters,asstatedinthespecifictechnicalstandards.
• Donotusedryingmachinestodrythedevice.

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6. SPECIFIC WARNINGS
Tousetheextricationdevice,youmustalsohaveread,understoodandcarefullyfollowalltheinstructionsintheusermanual.
• Alwayscomplywiththemaximumcapacity,ifany,indicatedintheUserManual.Maximumloadcapacitymeansthetotalweightdistributedaccordingtohuman
anatomy.Whendeterminingthetotalweightloadontheproduct,theoperatorshouldconsidertheweightofthepatient,equipmentandaccessories.Inaddi-
tion,theoperatorshouldassesswhethertheoverallsizeofthepatientreducesthefunctionalityoftheproduct.
• Thedevicemustonlybeusedbytrainedpersonnel
• Thedeviceisnotintendedforwinchingmanoeuvres.
• Attachingotherdevicesorsystemstothedevicethathavenotbeenapprovedbythemanufacturermaycauseseriousinjuriesand/orbeasourceofaccidents.
• Practiceundersimulatedconditionstoensurethatyouarefamiliarwiththemanoeuvres.
• Ifforeseenforthedevice,makesurethatoperatorsareingoodphysicalconditionbeforelifting,aslistedintheUserManual.
• The maximum weight, which weighs on each operator, must comply with local health and safety requirements.
• Establishamaintenanceprogramandperiodicchecks,identifyingadesignatedreferenceperson.Thepersonentrustedwithroutinemaintenanceofthedevicemustensure
thebasicrequirementsenvisagedbythemanufacturerwithintheseoperatinginstructions.
• Allmaintenanceactivitiesmustberecordedanddocumentedwiththerelevanttechnicalinterventionreports.Thisdocumentationmustbekeptforatleast10yearsafter
theendofthedevice’slifeandmustbemadeavailabletothecompetentauthoritiesand/orthemanufacturerwhenrequested.
• UseonlyoriginalorSpencerItaliaS.r.l.approvedcomponents/replacementpartsand/oraccessoriestocarryoutanyoperationwithoutcausingalterationsormodifications
tothedevice.Otherwise,wedeclineallresponsibilityregardingincorrectoperationoranydamagecausedbythedevicetothepatientortheoperator,invalidatingthe
warrantyandinvalidatingcompliancewithEURegulation2017/745.
• Neverleavethepatientonthedeviceunsupervised,astheycouldgetinjured.
• Avoidcontactwithsharpobjects.
• Theextricationdevicemustnotbeexposed,muchlesscomeintocontactwiththermalsourcesofcombustionorflammable
• FollowapprovedEmergencyMedicalServiceproceduresforpatientimmobilizationandtransportation.
• FollowapprovedEmergencyMedicalServiceproceduresforpatientpositioningandtransportation.
• Beforelifting,makesurethatoperatorshaveasecuregriponthesupportingstructureofthedevice.
• Donotbendtheextricationdeviceexcessivelyorforlongperiods.
• Donotapplythedeviceunlessthecervicalspinehasbeenimmobilisedwithasuitablecollar.
• Avoidtwistingthepatient’schestwhenapplyingthedeviceandadjustingthebelts.
• Atleasttwooperatorsinasuitablephysicalconditionarerequiredtousethedevice.Consequently,theymusthavestrength,balance,coordination,commonsenseandbe
trainedinthecorrectoperationandapplicationofthedevice.
• Forpatientloadingtechniquesforparticularlyheavypatients,foroperationsonsteepterrainorinspecialandunusualcircumstances,thepresenceofmorethantwoope-
ratorsisrecommendedinadditiontothetwominimumoperators.
• Beforeeachuse,alwayschecktheconditionsofthedeviceanditsaccessorycomponents,asspecifiedintheusermanual.Incaseoffaultsordamagethatmaycompromise
thefunctionalityandsafetyofthedevice,andthereforethepatientandtheoperator,removethedevicefromserviceorreplacethecomponentsthatarenotintact.
• Usethedeviceonlyasdescribedinthisusermanual.
• Donotarbitrarilyalterormodifythedevicetoadaptittounforeseenconditionsofuse:doingsocouldresultinunpredictableoperationanddamagetothepatientor
rescuersandshallvoidthemanufacturer’swarrantyandreleasethemanufacturerfromallliability.
• Topreservethelifeofthedevice,protectitasmuchaspossiblefromUVraysandadverseweatherconditions.
• Operatorsmustbefullyawareofthesequenceofbeltattachment.
7. RESIDUAL RISK
Noresidualrisks,orratherrisksthatcouldarisedespitecompliancewithallwarningsinthisusermanual,havebeenidentified.
8. TECHNICAL DATA AND COMPONENTS
Note: Spencer Italia S.r.l. reserves the right to make changes to specifications without notice.
ELEMENTS/DESCRIPTIONS AND MATERIALS
1
Nape cushion
PaddedandPVC-coated,providingsoft
support for the back of the patient’s
neck
5
Set of chin and forehead bands
Madeofpolypropylene,theyimprove
the fixation of the patient’s head to
thedevice.
2
Lifting handles
Made of polypropylene and placed
onthe backof thedevice,they allow
thedevicetobegrippedwhenapplied
to the patient to perform extrication
manoeuvres. 6
Main body
Madeofwoodensplints,coveredwith
PVCfabrictowhichtheotherelements
are sewn, it provides horizontal
flexibility to be wrapped around the
patient and offers vertical rigidity to
increase immobilisation.
3
Groin belts
Made of polypropylene, they are
passed through the groin area,
distributing the forces exerted during
extricationtothethigharea.
4
Abdominal belts
Madeofpolypropylene,theyallowthe
devicetobeattachedtothepatient.
TheXLaccessorysetcanbeappliedto
these,ifappropriate.
7
Nape area
Part of the main body on which
the strap strips are applied for the
applicationofthenapecushion

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SED SED XS
Length 830 mm 690 mm
Width 900 mm 640 mm
Maximumthickness(atthehooks) 25 mm 25 mm
Overalldimensionswrappedwithbag(approx.) 850x250x120mm 730x260x100mm
Beltlength 74 ± 2 cm 52 ± 2 cm
BeltlengthwithXLset - -
Materials PVC,Nylon,PP PVC,Nylon,PP
Weightwithoutbag 2,6kg 2,10kg
Weightwithbag 2,85kg 2,40kg
Maximumloadcapacity 230kg 60kg
9. COMMISSIONING
Forfirstuse,checkthat:
• Packagingisintactandhasprotectedthedeviceduringtransportation
• Checkthatallpartsincludedinthepackinglistarepresent
• Generalfunctionalityofthedevice
• Product cleanliness
• Therearenocuts,holes,lacerationsorabrasionsontheentirestructure,includingbeltsandfootrestswhereprovided.
• Correctstitchingandtighteningofbelts
Seeparagraph11onhowtocarryouttheabove-mentionedchecks.
Donotmodifythedeviceoritspartsforanyreasonasthiscouldcausedamagetothepatientand/orrescuers.
Failuretotaketheabovemeasureswillprecludesafeuseofthedevice,resultinginriskofdamagetothepatient,operatorsandthedeviceitself.
For subsequent use, perform the operations specified in paragraph 12.
Iftheaboveconditionsaremet,thedevicemaybeconsideredreadyforuse;otherwise,youmustimmediatelyremovethedevicefromserviceandcontacttheManufacturer.
Donotalterormodifythedevicearbitrarily,asdoingsocouldresultinunpredictableoperationanddamagetothepatientorrescuersandwillvoidthewarrantyand
releasetheManufacturerfromallliability.
10. OPERATING CHARACTERISTICS
Seeparagraph11-Properuseforoperatingcharacteristics.
11. PROPER USE
Primarymedicalevaluationsmustbecarriedoutbeforeinterveningonthepatient.
1 Applying the cervical collar: Before
applying the extrication device, it is
necessary to immobilise the cervical
section using a collar appropriate to
thepatient’scondition.
Follow local protocols as well as the
manufacturer’s user manual for the
collar in use.
3Releasethegroinstrapsfromthebackbylettingthemdropto
thesidesandwrapthethoracicflapsaroundthepatient’storso,
passingthemunderthearms.Adjusttheposition ofthedevice
byliftingitsothatthechestflapsbecomeasupportforthe ar-
mpits.Duringtheapplication,operatorsshouldavoidmovingthe
patient’sheadtoavoidaggravatinganyinjury.
Checkthatthedevicehasbeencorrectlypositioned,i.e.asclose
aspossibletothepatient’sbackandwellalignedwiththespine.
2Positioning the extrication device
behind the patient
Check that there are no items that
could obstruct the application of the
device(belt,wallet,etc.).
Openthe devicecompletely, turnthe
buckles towards the seat and tilt it
45°toinsert itbetween thepatient’s
backandtheseat,aligningitwiththe
patient’s spine.
4Fasten the chest belts in the following sequence. Generally
accepted as correct:
1–Intermediary(Yellow)
2–Lower(Red)
3–Upper(Green)
Thissequencemaynotbeindicatedinallrescuesituations.Fol-
lowtheinstructionsofyourlocalhealthauthority.
Whenapplyingittopregnantpatients,someofthethoracicflaps
havetobefoldedtoleavetheabdomenuncovered.
Apossible closureconfiguration,which mayvarydependingon
thesizeoftheabdomenandbreasts,isasfollows:
-Intermediarybeltintherespectivebuckle
-Lowerbeltinupperbuckle
-Upperbeltinthelowerbuckle
5Closethegroinstrapsbyslidingthem underthepatient’slegsusinganyfreespaceleft by
theseat.
Checkthatthebeltsarestraightinrelationtotheanchoragepointandascloseaspossibletothe
symmetryaxisofthedevice.
Hookthebeltsintotheirbucklesandtightenthemuntiltheycomeintocontactwiththepatient.
Afurthertighteningmustbecarriedoutbeforeextrication.
Theuseofcrotchbeltsrequiresparticularcareinthecaseoffemurorpelvisfractures.Thedevice
handlescanhelpobtainbetterverticalpositioningandalignmentofthedevice.

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6Donotimmobilisetheheaduntilcheckingthecorrectpositionoftheextricationdeviceinrelationtothesizeofthepatient.Takecare
nottocauseheadandneckmovementsthatcouldcompromisethepatient’scondition.Ifthereisagapbetweentheextricationdevice
andthepatient’shead,collarorshoulders,fillthenapespacewiththeappropriatesupportcushion,makingsurenottohyperextendor
flexthepatient’sneck.
Whileoneoperatorholdsthepatient’sheadinpositionandpositionstheflaps,theotheroperatormustsecuretheheadbandbytiltingthe
backslightlydownwards.Thisreducestheriskoftheheadbandslippingoverthehead.
Thenapplythechinstrap,takingcaretosupportthecervicalcollarandtiltittowardsthepatient’sears.Thisavoidsimmobilisingthejawand
preventingthemouthfromopening.Ensurethatthestrapsarecorrectlysecuredandsymmetricallypositioned.
7Whenthestretcherorspineboardhasbeenbroughttotheextricationsite,thefinalstepsoftheapplicationcanbecarriedout,i.e.
furthertighteningoftheextricationstraps,therefore:
1–Tightentheupperbelt(green)
2–Checkandtightenthelowerbelt(red)
3–Checkandtightenthegroinbelts.
Aftercheckingthecorrectapplication,thetwooperatorscangraspthehandlesofthedevicetorotatethepatientsothathisorherback
facestheinsideofthevehicle.Rotationmusttakeplacewithouttwistingthespinalcordorthecervicalspine.
Thetwooperatorscanthengraspthenearesthandleoftheextricationdevicewithonehandandthebackofthepatient’skneeswiththe
other.Aftercoordinatingtheoperationcorrectly,theycanliftthepatient.
Ifneeded,athirdoperatorcouldapplyaspineboard.
Theupperbelt(green)mustbeloosenedimmediatelyafterextricationtoallowforproperexpansionofthechest.
12. CLEANING AND MAINTENANCE
SpencerItaliaS.r.l.declinesallresponsibilityforanydirectorindirectdamagewhichistheconsequenceofimproperuseoftheproductandsparepartsand/orinany
caseofanyrepaircarriedoutbyapersonotherthantheManufacturer,whousesinternalandexternaltechniciansauthorisedtodoso;moreover,doingsowillinvalidate
thewarranty.
• Theoperatormustwearsuitablepersonalprotectiveequipment,suchasgloves,goggles,etc.duringallchecking,maintenanceandcleaningoperations.
• Establishamaintenanceschedule,periodicinspectionsandextendtheaveragelifespan,ifforeseenbytheManufacturerintheUserManual,identifyingareferenceperson
whomeetsthebasicrequirementssetforthintheUserManual.
• The frequency of inspections is determined by factors such as legal requirements, type of use, frequency of use, and environmental conditions during use and storage.
• Repairsof productsmanufacturedbySpencer ItaliaS.r.l. mustbe carried outby the Manufacturer, whoshallmakeuseof specialised internalor externaltechnicians
who, usingoriginalspareparts,shallprovidequalityrepairservice instrictcompliancewiththetechnicalspecificationsindicatedbytheManufacturer.SpencerItaliaS.r.l.
declinesanyresponsibilityforanydirectorindirectdamagewhichisaconsequenceofimproperuseofsparepartsand/oranyrepairworkcarriedoutbyunauthorised
parties.
• Whereforeseen,useonlyoriginalorSpencerItaliaS.r.l.approvedcomponents/sparepartsand/oraccessoriesinordertocarryoutalloperationswithoutcausingalterations
ormodificationstotheproduct.
• Allmaintenanceandoverhaulactivitiesmustberecordedanddocumentedwiththerelevanttechnicaloperationreports.Thisdocumentationmustbekeptforatleast10
yearsaftertheendoftheproduct’slifeandmustbemadeavailabletothecompetentauthoritiesand/ortheManufacturerwhenrequested.
• Cleaning,providedforreusableproducts,mustbecarriedoutinaccordancewiththeManufacturer’sinstructionsintheUserManualinordertoavoidtheriskofcross-in-
fectionduetothepresenceofbodyfluidsand/orresidues.
• Ifrequired,theproductandallitscomponentsmustbewashedandlefttodrycompletelybeforestorage.
12.1 CLEANING
Failuretocarryoutthecorrectcleaningoperationscouldincreasetheriskofcross-infectionduetopresenceofbodyfluidsand/orresidues.
Theoperatormustwearsuitablepersonalprotectiveequipment,suchasgloves,goggles,etc.duringallcheckingandcleaningoperations..
Cleanthedeviceanditspartswithsoapandwaterusingabrushwithmedium-hardbristles.Rinsethoroughlywithlukewarmwater,makingsureyouhaveremovedalltraces
ofsoap,whichmaydeteriorateorcompromiseconditionsanddurability.Avoid using high-pressure water.Letdrycompletelybeforestoring.Dryingafterwashingorafteruse
inawetenvironmentmustbenaturalandnotforced.Donotuseflamesorotherdirectheatsources.
Whendisinfecting,useproductsthatdonothaveasolventorcorrosiveactiononmaterialsconstitutingthedevice,inadditiontobeingclassifiedasmedical-surgicaldevices.
Besuretotakeallprecautionstoensurethatthereisnoriskofcross-infectionorcontaminationofpatientsandoperators.
Afterdisinfection,rinseallpartswithwarmwaterandallowthedevicetodrycompletelybeforestorage,asresidualmoisturemayleadtotheformationofmould..
12.2 ROUTINE MAINTENANCE
Theoperatormustwearsuitablepersonalprotectiveequipment,suchasgloves,goggles,etc.duringallchecking,maintenanceandcleaningoperations.
Thedevicedoesnotrequirearoutinemaintenanceprogram,butchecksmustbemadetoverify:
• All parts are present
• Integrityofthebelts
• Integrityoftheliftinghandles
• Integrityofthegroinbelts
• Integrityandoperationofthebuckles
• Integrityofinternalslats
• Integrityofthechinandforeheadbands
• Generalfunctionalityofthedevice
• Napecushionconditions
• Cleanlinessofthedevice(rememberthatthefailureofcleaningmaycausetheriskofcrossinfections)
• Fulfilmentoftherequirementsoftheusermanualinsection5Warningsand6SpecificWarnings.
• Fulfilmentoftherequirementsofthemanualinsection11Properuse
UseonlyoriginalorSpencerItaliaS.r.l.approvedcomponents/replacementpartsand/oraccessoriestocarryoutanyoperationwithoutcausingalterationsormodifications
tothedevice.Otherwise,wedeclineallresponsibilityregardingincorrectoperationoranydamagecausedbythedevicetothepatientortheoperator,invalidatingthe
warrantyandinvalidatingcompliancewithEURegulation2017/745.
12.3 PERIODIC OVERHAUL
Noperiodicoverhaulisforeseenforthedevice.

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Notice
Theinformationinthismanualissubjecttochangewithoutnotice.
Theimagesareincludedasexamplesandmayvaryslightlyfromtheactualdevice.
© Copyright Spencer Italia S.r.l.
Allrightsreserved.Nopartofthedocumentmaybephotocopied,reproducedortranslatedintoanotherlanguagewithoutpriorwrittenconsentfromSpencerItaliaS.r.l.
12.4 SPECIAL MAINTENANCE
SpecialmaintenancecanonlybecarriedoutbytheManufacturer,whousesinternalandexternaltechniciansspecialisedandauthorisedbytheManufactureritself.
OnlymaintenanceactivitiescarriedoutbyspecialisedtechniciansauthorisedbytheManufacturerareconsideredvalidbySpencerItaliaS.r.l..
Theend-usercanreplaceonlythesparepartsindicatedin§15.
12.5 LIFE SPAN
Thedevice,ifusedasdescribedinthefollowinginstructions,hasalifespanof5yearsfromthedateofpurchase.
SpencerItaliaS.r.l.willacceptnoresponsibilityforincorrectoperationordamagecausedbytheuseofdevicesthathaveexceededthemaximumallowablelifespan.
13. TROUBLESHOOTING TABLE
PROBLEM CAUSE REMEDY
Excessiveverticalbending Oneormoreoftheinternalslatsmaybebroken Putthedeviceoutofserviceimmediatelyandreplace
itwithasimilarone.
Thebucklesdonotcloseproperly Thebucklesmaybebroken Immediatelyremovethedevicefromserviceand
contactthemanufacturer
Thedevicehasmould Thedevicehasbeenstoredinveryhumidconditions
orwithoutwaitingforadequatedryingfollowing
cleaning procedures
Putthedeviceoutofserviceimmediatelyandreplace
itwithasimilarone.
If a problem or fault is detected that does not correspond to the above, please contact Spencer Italia Srl customer care service.
14. ACCESSORIES
Code Description Compatible
SR00101B SED XL KIT SED
15. SPARE PARTS
Code Description For model
RISR001 SED ADULT CHIN/NECK STRAP SET SED
RISR002 REPLACEMENT BAG FOR ADULT SED SED
RISR003 REPLACEMENT CUSHION FOR ADULT SED SED
RISR004 BLACKPLASTICMALE/FEMALEHOOKh50mm SED
RISR005 SED PEDIATRIC CHIN/NECK STRAP SET SED XS
RISR006 REPLACEMENT BAG FOR PEDIATRIC SED SED XS
RISR007 REPLACEMENT CUSHION FOR PEDIATRIC SED SED XS
RISR008 WHITEPLASTICMALE/FEMALEHOOKh50mm SED XS
16. DISPOSAL
Whendevicesandtheiraccessoriesarenolongersuitableforuse,theycanbedisposedofasnormalmunicipalsolidwasteiftheyhavenotbeencontaminatedbyspecial
agents.Otherwise,followtheregulationsinforceregardingdisposal.

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Quality System EN ISO 9001 – EN ISO 13485
Data Emissione 13/04/2021
Rev. 1 13/04/2021
Codice CCI5288
First issue: 13/04/2021
Rev. 1 13/04/2021
Code CCI5288
Erstausgabe: 13/04/2021
Rev. 1 13/04/2021
Code CCI5288
Première émission: 13/04/2021
Rév. 1 13/04/2021
Code CCI5288
Primera emisión: 13/04/2021
Rev. 1 13/04/2021
Código CCI5288
Primeira emissão: 13/04/2021
Rev. 1 13/04/2021
Código CCI5288
Πρώτη έκδοση: 13/04/2021
Αναθ. 1 13/04/2021
Κωδικός CCI5288
Първо издание: 13/04/2021
Рев. 1 13/04/2021
Код CCI5288
První vydání: 13/04/2021
Rev. 1 13/04/2021
Kód CCI5288