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Serie Profile – Spencer 450, 451, 455, 456 e 458
Dispositivo Medico
conforme al Regolamento
UE 2017/745
Profile Series – Spencer 450, 451, 455, 456 and 458
The device is in compliance
with the Regulation UE
2017/745
Manuale d'Uso e Manutenzione
Sistema di Garanzia di Qualità per la produzione ed il controllo finale dei prodotti
certificato dall'organismo notificato TÜV SÜD Product Service GmbH.
Guarantee of Quality system for the production and the final control of the products
certified by the notifying body TÜV SÜD Product Service GmbH.
SPENCER ITALIA SRL – Via Provinciale n° 12
SPENCER ITALIA SRL
43038 Sala Baganza (PR) – Italy
SEDIE PORTANTINE
User's Manual
TRANSPORT CHAIRS
IT
EN
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Table of Contents
Related Manuals for Spencer Profile Series
Summary of Contents for Spencer Profile Series
- Page 1 TÜV SÜD Product Service GmbH. UE 2017/745 User’s Manual Profile Series – Spencer 450, 451, 455, 456 and 458 TRANSPORT CHAIRS The device is in compliance Guarantee of Quality system for the production and the final control of the products with the Regulation UE certified by the notifying body TÜV SÜD Product Service GmbH.
- Page 2 4.3.2 CHIUSURA DEL DISPOSITIVO 4.3.3 PATIENT TRANSPORT WITH 4.3.3 TRASPORTO DEL PAZIENTE CON SEDIA THE TRANSPORT CHAIR WITH TWO WHEELS PORTANTINA A DUE RUOTE (SPENCER 450, 451 AVIO) (SPENCER 450, 451 AVIO) 4.3.4 PATIENT TRANSPORT WITH 4.3.4 TRASPORTO DEL PAZIENTE CON SEDIA THE TRANSPORT CHAIR WITH FOUR WHEELS...
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Page 3: General Information
When the devices are no more suitable for being used, if they haven’t been contaminated by any particular agents, they can be disposed of as normal solid waste, otherwise follow the current regulations about demolition. 1.6 LABELLING Each device has got an identifying label, positioned on the device itself and/or on the box. This label includes information about the manufacturer, the product, CE mark, lot number (LOT). It must never be removed or covered. WARNING 2.1 GENERAL WARNINGS • The product must be used by trained personnel only, having attended specific training for this device and not for similar products. • Training routines must be registered on a special register in which the names of those trained, of the trainers, date and place are indicated. This register which will certify the eligibility of the operators to use the Spencer device has to be kept for a period of 10 years after the disposal of the device itself. This register will be made available to the Competent Authorities and/or manufacturer if requested. • Spencer Italia S.r.l. is always at your disposal to plan trainings on products. • Before carrying out any kind of operation on the appliance (training, installation, use), the operator must carefully read the enclosed instructions, paying particular attention to the correct safety precautions and to the procedures to be followed for installation and for correct use. • If the instructions belong to another device and not the device received, inform the manufacturer immediately and avoid use of the device. • In the case of any doubts as to the correct interpretation of the instructions, please contact Spencer Italia S.r.l. for any necessary clarifications. • Do not allow untrained persons to help during the use of the device, because they could cause damage to the patient or to themselves. • Regularly check the appliance, carry out the prescribed maintenance and respect the average life span, as indicated by the manufacturer in this user’s manual. • Before each use of device the perfect operating state of the device must be checked as specified in the Instruction manual. If any damage or abnormalities which could in any way influence the correct functioning and the safety of the device, of the patient and or of the user are detected, the device must be immediately removed from service and the manufacturer must be contacted. • If any failure or incorrect functioning of the device is detected, it must be immediately substituted with a similar item so that the rescue procedures are guaranteed without any interruption. -
Page 4: Description Of Product
• Promptly notify Spencer Italia S.r.l. regarding any revisions to be made by manufacturer in order to guarantee the conformity of the product to the territory’s legal specifica- tions (including those resulting from rules and/or norms of other nature). • Act, with all due care and diligence, and contribute to ensure conformity to general safety requirements of all devices marketed in the territory, by providing final users with all necessary information for carrying out periodical checks on their devices, as specified in the relevant user manual. • Actively contribute to product safety checks on products sold, by communicating any relevant risk analysis information both to the manufacturer and to any competent authorities so that the necessary action can be promptly taken. • You are aware that in the event of any failure to conform to the above mentioned requirements you will be deemed fully responsible for all damages that might occur. Therefore we expressly disclaim any responsibility and/or liability for your non-compliance with the present “Regulatory provisions”. 2.2 SPECIFIC WARNINGS Establish a maintenance program and periodic testing, identifying a reference employee. The person to whom the ordinary maintenance of the device is entrusted • must ensure the basic requirements foreseen by the manufacturer in the user’s manual. • Training routines must be registered on a special register in which the names of those trained, of the trainers, date and place are indicated. This register which will certify the eligibility of the operators to use the Spencer device has to be kept for a period of 10 years after the disposal of the device itself. This register will be made available to the Competent Authorities and/or manufacturer if requested. • Use only accessories/spare parts that are original or approved by Spencer Italia S.r.l., in order to carry out any operation without causing any alteration or modification to the device, otherwise we assume no responsibility for the proper functioning or damage resulting from device to the patient or the operator and warranty and will be considered void according to the compliance to the Regulation UE 2017/745. -
Page 5: Main Components
ST41455A Spencer 455/BP transport chair with armrests and footrest ST46450C Spencer 450/B transport chair Spencer 450/B with two wheels certified 20G ST30456A Spencer 456 Avio transport chair with four wheels ST30467A Spencer 451 Avio transport chair with two wheels ST40456A Spencer 456/B Avio transport chair with four wheels and armrests ST30455A Spencer 455 transport chair with four wheels ST36453B Spencer 458 transport chair with four wheels certified 20G Spencer 458/B transport chair with four wheels and armrests ST36455C Spencer 455 transport chair with four wheels certified 20G ST36454B certified 20G 3.4 TECHNICAL DATA CHARACTERISTICS 451 AVIO 45 AVIO Height open (mm) Width (mm) Thickness folded (mm) Length with closed handles (mm) Length with open handles (mm) -
Page 6: Environmental Conditions
2. Close the device folding it over itself with mo- vements opposite to those described for the opening. 3. Check that the front pivoting wheels (where pre- sent) are correctly positioned, in order to allow a proper closing in little spaces. 4.3.3 Patient transport with the transport chair with two wheels (Spencer 450, 451 Avio) 1. Before loading the patient, move the transport chair as much as possible next to the patient. 2. Immobilize the patient to the device through the supplied belts, checking their correct positioning and sealing. 3. The first operator (in front of the patient) extracts the telescopic handles and tilts the device, while the second operator (located behind the patient) grabs the structure and moves the device towards him. -
Page 7: Troubleshooting
4. Maintain the rear wheels in contact with the ground and, to move, pull the transport chair in the desired direction. If necessary, it is recommended to employ more workers to maintain the condition of the patient and operator safety during handling. 4.3.4 Patient transport with the transport chair with four wheels (Spencer 455, 456 Avio, 458) 1. Before loading the patient, move the transport chair as much as possible next to the patient. 2. Immobilize the patient to the device through the supplied belts, checking their correct positioning and sealing. 3. Make sure all four wheels of the device are in contact with the ground. 4. Drive the transport chair in the desired direction, preferably pulling. Restrict the movement with the wheels only on flat surfaces. To overcome uneven or rough surfaces it is appropriate to lift the device. When lifting the transport chair, the operator in front of the patient should hold the telescopic handles, while the operator that stands behind the patient should grab the rear handles. The lift must occur in contemporarily. The operator that stands behind the patient will coordinate and guide the movements. If necessary, it is recommended to employ more workers to maintain the condition of the patient and operator safety during handling. 4.3.5 Patient transport on the stairs 1. Before loading the patient, move the transport chair as much as possible next to the patient. 2. Immobilize the patient to the device through the supplied belts, checking their correct positioning and sealing. 3. The first operator (in front of the patient) extracts the telescopic handles while the second operator (located behind the patient) grabs the rear handles. The lift must occur in contemporarily. The operator that stands behind the patient will coordinate and guide the movements. For the type of transport described or in the case of particularly demanding paths, it may be necessary to use a third operator with control functions and possible support. If necessary, it is recommended to employ more workers to maintain the condition of the patient and operator safety during handling. 4.3.6 Stationing of the device... -
Page 8: Maintenance
• Integrity of components • Integrity of handles (Are they torn or show signs of tearing? The seams are intact?) • Lubrication of moving parts • State of wear of wheels and braking system • Functioning of springs • The emergency vehicle is equipped with a Spencer fixing system dedicated to the chairThere are safety belts for the immobilization of the patient and they are intact and functioning • Welds are intact, with no cracks or breaks • No piping or metal sheet present bends or cracks • The backrest has no tears or cracks The inspection frequency is determined by factors such as legal requirements, the type of use, frequency of use, environmental conditions during use and storage. Please note that you must do the cleaning as described in paragraph 5.1 and verify functionality before and after each use. Spencer Italia S.r.l. declines any responsibility for the... - Page 9 7.2 SPARE PARTS ST21400A Wheel Ø 100 mm grey, pivoting with brake of rolling and axis ST30448A PVC black handle with hole 30 x 8 for rear handles ST21401C Wheel Ø 100 mm with bearing ST30453A Seat cover for Spencer 450, 455, 458 in orange PVC ST22400A Wheel Ø 125 mm grey, antistatic ST30454A Backrest cover for Spencer 450 and 455 in orange PVC ST22401A Wheel Ø 150 mm with bearing with black holecover ST30462A Lower cover for Spencer 450 and 455 in orange PVC ST22402A Wheel Ø 150 mm with bearing ST30464A Upper cover for Spencer 451 and 456 ST30449A PVC black handle for front handles ST30463A Pair of belts for Spencer 451, 456 ST30441A Rear handle for Spencer 450, 451, 455, 456 and 458 ST30473A Polyurethane covered armrest for Spencer 450, 455 B, 427 and 458 B ST30443A Pair of belts for Spencer 450, 451, 455, 456 and 458 ATTACHMENT A – TRAINING REGISTE The product must be used by trained personnel only, having attended specific training for this device and not for similar products. Keep this document at least 10 years from the end of life of the device.
- Page 10 ATTACHMENT B – MAINTENANCE REGISTE Keep this document at least 10 years from the end of life of the device. Perform the required maintenance and to respect the life span of the device, as indicated by the manufacturer in the user’s manual. Code and description of the device Purchase date Lot (LOT) or serial number (SN) Bought by Warning The information contained in this document could be modified without any warning and is not to be intended as a commitment on behalf of Spencer Italia S.r.l. Spencer products are exported to many countries and the same identical regulations are not always valid. For this reason there could be differences between the description here described and the product actually delivered. Spencer continually strives to reach the perfection of all items sold. We therefore hope you will understand if we reserve the right, at any time, to modify the shape, equipment, lay-out or technical aspects that are herein described. © Copyright Spencer Italia S.r.l. All rights reserved. No part of this document can be photocopied, reproduced or translated into another language without the written approval of Spencer Italia S.r.l.
- Page 11 CCI5300 Prima emissione: 11/05/2021 Rev. 0: 11/05/2021 CCI5300 First edition: 11/05/2021 Rev. 0: 11/05/2021 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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