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Manuale d'uso e manutenzione
Use and Maintenance Manual
Benutzungs- und Wartungshandbuch
Manuel d'utilisation et d'entretien
Manual de uso y mantenimiento
SED – Dispositivo de extricación
Manual de uso e manutenção
SED - Dispositivo de extração
Εγχειρίδιο χρήσης και συντήρησης
SED - Γιλέκο απεγκλωβισμού
Ръководство за употреба и поддръжка
SPENCER ITALIA SRL – Via Provinciale n° 12
SPENCER ITALIA SRL
43038 Sala Baganza (PR) – Italy
SED - Estricatore
SED - Extrication device
SED - Rettungskorsetts
SED - Attelle d'extraction
SED - Гърбодържател
Návod k použití a údržbě
SED - Vyprošťovací korzet
IT
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Summary of Contents for Spencer SED
- Page 1 Εγχειρίδιο χρήσης και συντήρησης SED - Γιλέκο απεγκλωβισμού Ръководство за употреба и поддръжка SED - Гърбодържател Návod k použití a údržbě SED - Vyprošťovací korzet SPENCER ITALIA SRL SPENCER ITALIA SRL – Via Provinciale n° 12 43038 Sala Baganza (PR) – Italy...
- Page 2 INDICE / CONTENTS / INHALTSVERZEICHNIS / SOMMAIRE / ÍNDICE MODELLI SYMBOLE DESTINAZIONE D’USO GARANTIE UND KUNDENDIENST DESTINAZIONE D’USO E BENEFICI CLINICI WARNUNGEN/GEFAHREN PAZIENTI DESTINATARI SPEZIFISCHE HINWEISE CRITERI DI SELEZIONE PAZIENTI RESTRISIKO CONTROINDICAZIONI ED EFFETTI COLLATERALI TECHNISCHE DATEN UND KOMPONENTEN INDESIDERATI INBETRIEBNAHME UTILIZZATORI E INSTALLATORI 10.
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Page 3: Intended Use
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. 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... -
Page 4: Warranty And Service
Date of manufacture Product code Caution: Federal Law restricts this device to sale by or on the order of a Unique Device Identifier 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 service@spencer.it 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. -
Page 5: Specific Warnings
• 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. RESIDUAL RISK No residual risks, or rather risks that could arise despite compliance with all warnings in this user manual, have been identified. TECHNICAL DATA AND COMPONENTS Note: Spencer Italia S.r.l. reserves the right to make changes to specifications without notice. ELEMENTS/DESCRIPTIONS AND MATERIALS Nape cushion Set of chin and forehead bands Padded and PVC-coated, providing soft Made of polypropylene, they improve support for the back of the patient’s the fixation of the patient’s head to... - Page 6 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...
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Page 7: 12. Cleaning And Maintenance
• 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. -
Page 8: 13. Troubleshooting Table
The device has mould The device has been stored in very humid conditions Put the device out of service immediately and replace or without waiting for adequate drying following it with a similar one. cleaning procedures 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 15. SPARE PARTS... - Page 9 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 spencer.it support.spencer.it - e-mail: info@spencer.it | service: service@spencer.it Ph./Tel. +39.0521.541111 Quality System EN ISO 9001 – EN ISO 13485...
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