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Spencer 420, User Manual

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Spencer 420 User Manual Download Page 11

11 

ATTACHMENT A – TRAINING REGISTER 

 

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. 

 

Operator’s 

name 

Training date 

Training method (user’s 

manual, during service, 

former class, etc.) 

Trainer 

Basic training 

Advanced 

training 

 

 
 

 

 

 

 

 
 

 

 

 

 
 

 

 

 

 

 
 

 

 

 

 

 
 

 

 

 

 

 
 

 

 

 

 

 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Summary of Contents for 420

Page 1: ...of Quality system for the production and the final control of the products certified by the notifying body TÜV SÜD Product Service GmbH INDEX General information page 2 Warnings page 2 Description of product page 5 Operating instructions page 6 Maintenance and cleaning page 8 Accessories and spare parts page 10 First edition 25 08 09 Rev 1 21 11 12 ...

Page 2: ...r the product CE mark lot number LOT It must never be removed or covered 2 WARNINGS 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 ...

Page 3: ...u are strictly required to have a basic knowledge of any legal requirements applying to the devices contained in this supply that are in power in the goods final destination Country including laws and norms regarding technical specifications and or safety requirements and therefore you are also strictly required to have the necessary knowledge to guarantee all aspects regarding the total conformit...

Page 4: ...ious damage Use the chair only as described in this user s manual Pay a lot of attention to possible obstacles water ice debris etc on the route of the stretcher because they could cause loss of balance for the operator and compromise the proper functioning of the device If you can not set the path free from obstacles choose an alternative path For slopes greater than 10 mm the device must be rais...

Page 5: ... to use devices having a greater encumbrance Weld Series transport chairs Spencer 420 425 and 427 are characterized by an extremely low weight and by the simplification of closing and opening operations which are completely automatic It is not expected that the patient can intervene on the device 3 2 Main components n Description of component Material 1 Backrest cover PVC 2 Backrest frame Steel 3 ...

Page 6: ...cal devices manufacturer CEI EN 62366 Medical Devices Application of the utilisation characteristics of engineering to medical devices MEDDEV 2 4 1a b Guideline for the classification of medical devices NB MED 2 5 1 Rec 5 Technical Documentation MEDDEV 2 7 1 Clinical Data MEDDEV 2 12 1 Medical Devices vigilance system UNI EN 14155 Clinical evaluation of the medical devices for human beings Part 2 ...

Page 7: ...ckrest has no tears or cracks 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 4 3 Functioning In any case during the use of the transport chair all operators involved in handling operations must be in position facing the patient 4 3 1 Opening the device Stand at the side of the tra...

Page 8: ... use a third operator with control functions and possible support 4 4 Troubleshooting PROBLEM CAUSE REMEDY The device can not be released from the closed or open position Geometry of operation compromised or seized Verify after proper lubrication if the problem persists if so put the device out of service immediately and contact the service centre or the manufacturer Compass locking system damaged...

Page 9: ...on 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 par...

Page 10: ...piry date by the manufacturer or by one of the manufacturer s authorised service centres making void the guarantee and the conformity to the Medical Devices Directive 93 42 CEE 6 ACCESSORIES AND SPARE PARTS 6 1 Accessories ST30451A Fixation system ST36451B F 400 Fixation system 20 G ST00428B Stabilizer Padded seat backrest 6 2 Spare parts ST00421A Backrest cover in orange PVC heavy ST00422A Seat c...

Page 11: ...y 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 Operator s name Training date Training method user s manual during service former class etc Trainer Basic training Advanced training ...

Page 12: ...uld 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 so...

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