Spencer CONTOUR User manual

SUPERCONTOUR TANGO FIX
SUPER HP
SUPER SX
CONTOUR HP
FXA PRO
PEDI FIX
PEDI GO
SPENCER ITALIA SRLSPENCER ITALIA SRL – Via Provinciale n° 12
43038 Sala Baganza (PR) – Italy
DA
Bruger- og vedligeholdelsesvejledning
HOVED- OG ANKELIMMOBILISATOR
NL
Gebruikers- en onderhoudshandleiding
HOOFD- EN ENKELSTEUNEN
RO
Manual de utilizare și întreținere
IMOBILIZATORUL PENTRU CAP ȘI SISTEMUL
DE IMOBILIZARE A PICIOARELOR
BG
Ръководство за употреба и поддръжка
ИМОБИЛИЗАТОР ЗА ГЛАВА И ОРТЕЗА ЗА
ИМОБИЛИЗАЦИЯ НА ГЛЕЗЕН
EL
Εγχειρίδιο χρήσης και συντήρησης
ΑΚΙΝΗΤΟΠΟΙΗΤΗΣ ΚΕΦΑΛΗΣ ΚΑΙ ΑΣΤΡΑΓΑΛΩΝ
PT
Manual de Uso e Manutenção
IMOBILIZADOR DE CABEÇA E IMOBILIZADOR DE TORNOZELO
ES
Manual de uso y mantenimiento
INMOVILIZADOR DE CABEZA E INMOVILIZADOR DE TOBILLOS
FR
Manuel d’utilisation et d’entretien
IMMOBILISATEUR DE TÊTE ET DE CHEVILLES
DE
Benutzungs- und Wartungshandbuch
KOPFHALTER UND KNÖCHELHALTER
EN
Use and Maintenance Manual
HEAD RESTRAINTS AND ANKLE RESTRAINTS
IT
Manuale d’uso e Manutenzione
FERMACAPO E FERMACAVIGLIE

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1. MODELS
The following basic models may be subject to implementation or change without notice.
• CONTOUR • FXA PRO • SUPER HP • TANGO FIX • PEDI GO
• CONTOUR HP • SUPER • SUPER SX • PEDI FIX
2. INTENDED USE
2.1 INTENDED USE AND CLINICAL BENEFITS
Headandanklerestraintsareaccessoriesforspineboardsorpick-upstretchers,tobeusedtoincreasethedegreeofpatientimmobilisation.
2.2 TARGET PATIENTS
There are no particular indications related to the patient group.
The target patients are those for whom use of a spine board or pick-up stretcher is foreseen.
2.3 PATIENT SELECTION CRITERIA
The patients expected are those for whom use of a spine board or pick-up stretcher is foreseen.
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 individuals with suspected spinal trauma or who require
immobilisation. The user must be able to evaluate the most suitable type of device for use on the specific patient.
These devices are not intended for lay people.
Operators must be able to provide the necessary patient care.
The product must be used only by personnel trained in the use of this product and not on other similar products.
3. REFERENCE STANDARDS
REFERENCE DOCUMENT TITLE
EU Regulation 2017/745 EU Regulation on Medical Devices
4. INTRODUCTION
4.1 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).
4.2 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)
4.3 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.
SpencerCustomerServicetel.+390521541154,fax+390521541222,e-mail[e-mail]
Warranty and service conditions are available on the website http://support.spencer.it
5. WARNINGS/DANGERS
Product features
Use of the product for any purpose other than that described in the User Manual is prohibited.
• The product must not be tampered with or modified without the manufacturer’s authorisation.
• Avoid contact with sharp or abrasive objects.
• Operating temperature: from -5°C to + 50°C.
• Storage temperature: -10°C to +60°C.
General warnings for medical devices
• Donotuseifthedeviceorpartsofitarepunctured,torn,frayed,orexcessivelyworn.
• Donotalterormodifythedevicearbitrarily,asdoingsocouldresultinunpredictableoperationanddamagetothepatientandshallvoidthemanufacturer’swarrantyand
release the manufacturer from all liability.
• 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.
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.
6. SPECIFIC WARNINGS
Tousetheheadandanklerestraints,youmustalsohaveread,understoodandcarefullyfollowalltheinstructionsintheusermanual.
• Perform immobilisation simulations with dummies before putting the device into service.

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• Improper use may result in injury or permanent disability. Always follow the procedures and protocols approved by the relevant Emergency Medical Service.
• Theseinstructionsprovideinformationonthefunctionalityandapplicationofthedeviceanddonotaddresspatientpositioningprocedures,forwhichitisadvisable
to always follow the guidelines of the relevant emergency medical service.
• Topreservethelifeofthedevice,protectitasmuchaspossiblefromUVraysandadverseweatherconditions.
• 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 device must only be used by trained personnel.
• Qualified personnel must be present during use of the device.
• At least two rescuers must be present for correct application of the device.
• Operators must be able to assess the patient’s injuries and decide whether the use of the device is appropriate.
• Beforeusingtheheadoranklerestraints,assesstheneedfortheirapplicationaccordingtotheclinicalconditionofthepatientandmakesurethatthemostsuitabletype
of device is used.
• Operatorsmustbeabletoassessthemostsuitabletypeofheadrestraintforuse,takingintoaccountthetypeofpatientandthecharacteristicsoftheinjuries.
• Thedevicemustnotbeexposed,muchlesscomeintocontactwiththermalsourcesofcombustionorflammableagents.
• Always check the conditions of all parts before use.
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
CONTOUR / CONTOUR HP SUPER/SUPER HP TANGO FIX / PEDI GO
FXA PRO SUPER SX PEDI FIX
Cushions:Madeofpolyurethanefoam,theyimmobilisethepatient’sheadfromlateralmovement.
Base:MadeofpaddedPVC,orrigidpolyethylenefortheHPversions,itisusedforanchoringtotheprimaryimmobilisationdevice(e.g.spineboardorpick-upstretcher).It
is equipped with strap inserts for the application of cushions.
Ankle restraints:Madeofrigidpolyethylene,itisequippedwithstrapsforapplicationtothespineboardaswellasforfixingtheankles.
9. PROPER USE
Operators performing immobilisation must be able to select the most suitable type of head restraint.
Regardlessofthetypeofheadrestraintused,makesurethattherearenoconditionsthatarenotcompatiblewithuseofthisdevice(i.e.penetratingbodies).
9.1 APPLYING THE HEAD RESTRAINT BASE TO THE SPINE BOARD
1 – Insert the upper belt into the hole provided on the
spine board.
2 – Pull out the strap from the opposite side. 3 – Pass the strap through the dedicated slot.
4 – Close the strap by adhering the strap. 5 – Pass the lateral straps through the holes present
on the spine board.
6 – Pass the straps underneath the board and insert
them into the two holes on the opposite side of the
board.
7 – Fix the straps on the base of the head restraint,
making the strap properly adheres.

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Warning
The information contained in this document is subject to change without notice and is to be intended as a commitment by Spencer Italia S.r.l. subject to change.
© 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.
Thecushionscanbeappliedaftermakingsurethatthebaseisproperlysecured,placingthemonthebaseandhavingthestrapsadhere..
Pedi Go is not equipped with a base and therefore cushions must be applied directly on the Baby Go spine board at the strap areas.
Oncethepatientispositionedaccordingtotheprotocolsapprovedbyyouremergencymedicalservice,attachthecushionswiththechinandforeheadstrapsprovidedwith
the headband.
If the device is to be used with paediatric patients on the Tango Fix,thepaediatriccushionscanberemovedfromtheadultcushions,thenappliedasdescribedabove.
9.2 APPLYING THE SUPER SX HEAD RESTRAINT
• Carefully clean the surface of the pick-up stretcher so that no dust or oily residues are present.
• Apply the strap adhesive elements in the head rest area where the head restraint is to be applied.
• Cushions can be applied during patient positioning manoeuvres by placing them in the dedicated strap areas and attaching them to the patient
by means of the chin and forehead straps.
9.3 APPLYING THE ANKLE RESTRAINTS
• Afterpositioningthepatientontheboard,insertthedevicebelowtheanklessothatthelogorepresentingthefeetisvisibletotheoperator.
• Wraptheankleswiththestraps,passthemthroughtheeyeletsoneithersideofthedeviceand,afterwrappingthemaroundthehandles,closethemonthemselvesby
adhering the strap inserts.
10. CLEANING AND MAINTENANCE
10.1 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 exposed parts with water and delicate soap. Never use solvents or stain removers.
Rinsethoroughlywithlukewarmwater,makingsureyouhaveremovedalltracesofdetergent,whichmaydeteriorateorcompromiseconditionsanddurability.Theuseof
high-pressure water should be avoided.
Allow to dry thoroughly 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.
Ifbloodisvisible,oxidiseitbeforewashingwithwater.
If 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.
10.2 MAINTENANCE
Thedevicedoesnotrequirearoutinemaintenanceprogram,butchecksmustbemadetoverify:
• General functionality of the device.
• 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 Warnings and Specific Warnings.
• Fulfilment of the requirements of the manual in section on Proper use.
No periodic overhaul is foreseen for the device.
10.3 LIFE SPAN
Thedevice,ifusedasdescribedinthefollowinginstructions,hasalifespanof5yearsfromthedateofpurchase.
11. TROUBLESHOOTING TABLE
PROBLEM CAUSE REMEDY
The straps do not adhere correctly The straps are dirty Remove any residue from the straps.
Excessive device mobility The base is excessively mobile with respect to the
spinal board to which it is attached
Tighten the fixing straps around the spine board
The device has tears or other damaged parts Misuse or normal wear and tear Put the device out of service immediately and replace
it with a similar one
12. ACCESSORIES
There are no accessories present.
13. SPARE PARTS
CODE DESCRIPTION CODE DESCRIPTION
RISH002 SET OF HEAD RESTRAINT CHIN/FOREHAND STRAPS RISH003 SET OF HP HEAD RESTRAINT CHIN/FOREHAND STRAPS
14. 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
Prima emissione: 28/04/2021
Rev. 1 28/04/2021
Codice CCI5155
First issue: 28/04/2021
Rev. 1 28/04/2021
Code CCI5155
Erstausgabe: 28/04/2021
Rev. 1 28/04/2021
Code CCI5155
Première émission: 28/04/2021
Rév. 1 28/04/2021
Code CCI5155
Primera emisión: 28/04/2021
Rev. 1 28/04/2021
Código CCI5155
Primeira emissão: 28/04/2021
Rev. 1 28/04/2021
Código CCI5155
Πρώτη έκδοση: 28/04/2021
Αναθ. 1 28/04/2021
Κωδικός CCI5155
Първо издание: 28/04/2021
Рев. 1 28/04/2021
Код CCI5155
Prima întocmire: 28/04/2021
Rev. 1 28/04/2021
Cod CCI5155
Første udgave: 28/04/2021
Rev. 1 28/04/2021
Kode CCI5155
Eerste uitgave: 28/04/2021
Herz. 1 28/04/2021
Code CCI5155