User's Manual 20 G Fixing system for transport chairs
Contents
1. after each use and at least every 3 months are as follows General functionality of the device Cleanliness of the device remember that the failure of cleaning may cause the risk of cross infections Absence of cuts holes tears on the structure including the straps Correct fixation of all nuts bolts and screws State of use moving parts Integrity of components Lubrication of moving parts Functioning of springs Weldings are intact without any cracks or breaks No piping or metal sheet present bends or cracks The person responsible for routine maintenance must identify damaged worn parts but the replacement or restoration of them can only be carried out by the manufacturer or or by an authorized service centre 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 proper functioning or damages caused to the patient or user by the use of devices not subject to routine maintenance warranty and will void the compliance to the Medical Device Directive 93 42 CEE 5 2 2 Periodic maintenance The device must be serviced by the manufacturer or by an authorised centre every year If the correct revision is not carried out the CE branding will no longer be2. considered valid as the product will no longer be compliant with the 93 42 CE Directive for Medical Devices and consequently it is no longer compliant with the safety standards declared by the Manufacturer at time of purchase Spencer Italia S r l will take no responsibility the incorrect functioning or any damage caused by a device that has not undergone regular revision For any operations that are not carried out directly by the Manufacturer but by an authorised centre we have to underline that a report regarding all operations carried out must be requested This will permit both Spencer Italia S r l and the end user to keep a log book regarding the operations carried out on the device 5 2 3 Special servicing Only the Manufacturer or centres with written authorisation are authorised to complete any special servicing operations For any operations that are not carried out directly by the Manufacturer but by an authorised centre we have to underline that a report regarding all operations carried out must be requested This will permit both Spencer Italia S r l and the end user to keep a log book regarding the operations carried out on the device The device if used as indicated in the following instruction manual has an average life span of 5 years The life span can be expanded only following a general revision of the product that must be carried out by the Manufacturer or by a centre authorised by the Manufacturer Spencer Italia S r l
3. ICE extension of life span 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 10
4. RODUCT 3 1 Intended use Spencer F 400 e F 400 A sono sistemi di fissaggio destinati alle sedie portantine delle Serie Profile e Weld Questi dispositivi consentono la completa stabilita della sedia portantina all interno del vano dell ambulanza Spencer F 400 and F 400 A are fixing systems dedicated to the Spencer transport chairs of the Profile and Weld Series These devices permit a total stability of the transport chair inside the ambulance 3 2 Main components Description of Material component aa C 1 Self fastening belt Metal 2 Fastening hooks Steel 6 for tran sport chair Hook activation Steel 3 pedal 4 Screws for floor Steel fixation 4 5 Hook base Steel S Belt for upper a 5 6 fixation Polypropylene 4 sS 7 Upper profile Steel Fig A 3 3 Models These basic models could be modified with reference to codes and or descriptions without any previous notification ST36451B F 400 Complete 20 G Fixing system for transport chairs ST36458B F 400 A Complete 20 G Fixing system for Avio transport chairs 3 4 Dati tecnici Characteristics F 400 F 400 A Base width mm 401 335 Base thickness mm 72 72 Base heigth mm 80 80 Width of upper part mm 480 420 Thickness of upper part mm 30 30 Heigth of upper part mm 60 60 Weight kg 1 9 1 6 3 5 Reference standards MDD 93 42 CEE European Directive about Medical Dev
5. User s Manual F 400 20 G Fixing system for transport chairs C This appliance conforms with the Directive 93 42 CEE Medical Devices Guarantee of Quality system for the production and the final control of the products certified by the notifying body T V S D Product Service GmbH INDEX General information page 2 Operating instructions page 5 Warnings page 2 Maintenance and cleaning page 7 Product description page 4 Accessories and spare parts page 8 First edition 30 11 2009 Rev 2 13 05 2014 Spencer Italia S r l Strada Cavi 7 43044 Collecchio PR ITALY WWW Ss NICER t Tel 39 0521 541111 Fax 39 0521 541222 E mail info spencer it _ Thank you for choosing a Spencer product 1 GENERAL INFORMATION 1 1 Aim and contents The aim of this manual is to supply all the information necessary so that the client will not only attain adequate use of the appliance he will also be capable of using the instrument in the most autonomous and secure way possible This includes information regarding technical aspects functioning maintenance spare parts and safety 1 2 Conservation of the instruction and maintenance manual The instruction and maintenance manual must be kept together with the product for the whole life of the device inside a dedicated container and above all away from any substances or liquids which could compromise perfect legibility 1 3 Symbols used Symbol Meaning t Gene
6. at there are no risks of shocks bumps or falls during the transport itself Keep the original packaging for use in case of any further transport and for storage Damage to the appliance caused during transport and handling is not covered by the guarantee Repairs or replacement of the damaged parts are the responsibility of the client The device must be stored in a dry cool area away from direct sunlight It must not be placed in contact with any substances or chemical agents which could cause damage and reduce safety characteristics 4 2 Preparation On receipt of the product e Remove the packaging and display the material so that all components are visible e Check that all the components pieces on the accompanying list are present The appliance must be checked before every use so as to reveal any working abnormalities and or damage caused by transport and or storage In particular check General functionality of the device Cleanliness of the device remember that the failure of cleaning may cause the risk of cross infections Absence of cuts holes tears on the structure including the straps Correct fixation of all nuts bolts and screws State of use moving parts Integrity of components Lubrication of moving parts Functioning of springs Weldings are intact without any cracks or breaks No piping or metal sheet present bends or cracks If the above conditions are met the device may be considered ready for use otherwise you
7. d 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 e Spencer Italia S r l is always at your disposal to plan trainings on products e 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 e If the instructions belong to another device and not to the device received inform the manufacturer immediately and avoid use of the device e In case of any doubts about the correct interpretation of the instructions please contact Spencer Italia S r l for any necessary clarifications e Do not allow untrained persons to help during the use of the device because they could cause damage to the patient or to themselves e 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 2 2 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 functi
8. ease mechanism has not The chair does not unblock Activate the lever with your foot been operated The springs are damaged The fixing system does not function The mechanism and or the wheel pivots are damaged and or worn Put the device out of service and contact the service center Put the device out of service and contact the service center Improper use or not adequately Put the device out of service and contact trained staff the service center The belt is not tight enough or is blocked The reel is not working properly Damages to the structure 5 MAINTENANCE AND CLEANING 5 1 Cleaning Failure to carry out the correct cleaning routine could increase the risk of cross infection due to presence of body fluids and or residuals The operator must always wear adequate personal protection such as gloves and mask etc during all checking and cleaning procedures The exposed metal parts are usually treated and or painted in order to increase their resistance Clean the exposed parts with water and delicate soap then dry with a soft cloth In order to obtain a shine effect it is possible to use car waxes and creams Do not clean with high pressure water this will damage the joints and the lubricated parts We recommend the use of the polishing detergent Spencer STX 99 Rinse thoroughly with warm water making sure that you have removed all traces of detergent which could degrade or compromise the integ
9. evice is being used the assistance of qualified staff must be guaranteed Never leave the patient unassisted on the device because he may be injured Do not store the device underneath any heavy objects which could cause structural damage Store in a cool dry dark place and do not expose to direct sun Store and transport device in its original packaging The device not be exposed to or come into contact with any source of combustion or inflammable agents Position and adjust the device taking care not to cause any obstruction to rescuers and or any other rescue equipment Attention laboratory testing post production tests instruction manuals cannot always consider every possible scenario for use This means that in some cases the performance of the product could be notable different from results to date obtained Instructions are continually being updated and are under tight surveillance of fully qualified staffs with adequate technical formation With reference to the D Lgs 24th February 1997 n 46 emended by D Lgs 25 01 2010 n 37 Acknowledgement of Directive 93 42 CEE and 2007 47 CE we remind both public and private operators that they are obliged to report any accident that involves any medical device to the Ministry of Health and to the Manufacture as specified and within time given by the European regulations Specific warnings Establish a maintenance program and periodic testing identifying a reference employee The person t
10. ices Modifications to 90 385 CEE Directive about active implants Directive MDD 2007 47 CEE 93 42 CEE about medical devices and Directive 98 8 CE about the introduction of biocides onto the market Legislative Decree 24 02 1997 n 46 Application of the 93 42 CEE Directive about Medical Devices Legislative Decree 25 01 2010 n 35 Modifications and additions to the 20 02 97 Decree n 46 UNI EN 1789 medical vehicles and their equipment Ambulances UNI EN ISO 14971 Application of risks managing to medical devices Medical devices Symbols for use in the medical device labels labelling and information to be provided Part 1 general requirements UNI CEI EN 1041 Information supplied by the medical devices manufacturer Medical Devices Application of the utilisation characteristics of engineering UNI CEI EN ISO 15223 1 CEI EN 62366 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 Clinical evaluation plans 4 3 6 Environmental conditions Functioning temperature from 20 to 60 C Storage temperature from 20 to 60 C 4 OPERATING INSTRUCTIONS 4 1 Transport and storage Before transporting the appliance make sure that it is correctly packaged ensuring also th
11. must immediately remove the device from service and contact the Manufacturer 4 3 Requirements for the emergency vehicle Spencer F 400 and F 400 A have been designed for installation on an ambulance vehicle The vehicle should have the following characteristics e Levelled tread surface perfectly vertical e Tread surface long and large enough to freely house the fixing system e In order to ensure a proper use of the fixing system it is recommended to install it on an emergency vehicle compliant with the requirements specified in EN 1789 otherwise the manufacturer will not be held responsible for any errors or faults generated by the fixing on an unsuitable surface 4 4 Functioning 4 4 1 Blocking the chair to the fixing system 1 Load the transport device onto the ambulance as required for standard use 2 Take the chair in its closed position next to the fixing system with a little inclination 3 When the chair is next to the fixing system rise the pedal with your foot n 3 par 3 2 in order to allow the wheel pivots to slide under the fixing fork n 2 par 3 2 4 Release the pedal and make sure that the transport chair is correctly fixed to the base of the F 400 or F 400 A fig C Rotate the chair until it reaches complete contact with the wall 6 Fasten the belt n 6 par 3 2 making sure to maintain the chair s handles inside its structure fig D lower miniature and verifying if the belt has got enough tension so as t
12. o avoid any movement of the chiar 7 Make sure the chiar is securely anchored by performing repeated movements of some traction oa 4 4 2 Unblocking the chair from the fixing system 1 Release the belt 2 With your foot action the pedal placed at the base of the fixing system in order to allow unblocking of the wheel pivots from the hook 3 Move the transport chair towards your body and release the pedal 4 4 3 Fixing of hook to platform The installation of the device must be performed only by trained and authorized personnel An incorrect installation will invalidate the safety standards with which the device has been designed and built 1 1 Position the base of the hook at a distance between 27 mm and 30 mm from the wall D fig E 2 Use the base as a die to mark the position of the fixing screws on the floor 3 Fix the base using two screws TCEI M8 type class of resistance 8 8 and washers 8x24x2 mm 4 The axis of the holes of the upper part of the hook must be positioned at a height H from the ground equal to 625415 mm fig F Even in this case use the hook as a die 5 For the fixing use two screws TCE M8 type class of resistance 10 9 and washers 8 mm On the opposite side of the wall use a counterplate not supplied and self locking nuts M8 type Fig E y Fig F oe 4 5 Troubleshooting PROBLEM CAUSE REMEDY The rel
13. o whom the ordinary maintenance of the device is entrusted must ensure the basic requirements foreseen by the manufacturer in the user s manual All maintenance and periodic check activities must be registered and collected together with their intervention reports see Maintenance Register these documents have 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 components spare parts and or accessories 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 Medical Device Directive 93 42 CEE The device and all its components after washing should be allowed to dry completely before storing Lubrication must be carried out after cleaning and complete drying Avoid contact with sharp objects Do not use the device if it is eccessively worn out Condensation water ice and accumulation of dust can affect the correct operation of the device 2 3 Contraindications and side effects The use of this device if used as described in this manual does not present any contraindications or collateral effects 3 DESCRIPTION OF P
14. oning and the safety of the device of the patient and 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 Use of the device in anyway other than described in this manual is forbidden Do not alter or modify in any way the appliance any such interference could cause malfunctions and injury to the patient and or rescuer The appliance must not in any way be tampered with modification adjustment addition replacement In such cases all responsibility will be denied for any malfunctions or injuries caused by the appliance itself moreover CE certification and product warranty will be considered void Those who modify or have modified prepare or have prepared medical appliances in such a way that they no longer serve the purpose for which they were intended or no longer supply the intended service must satisfy the valid conditions for the introduction onto the market Handle with care Ensure that all the necessary precautions are taken in order to avoid the hazards that can arise as the result of contact with blood or body fluids Register and store with these instructions serial number place and date of purchase first date of use date of checks name of users any comments When the d
15. ral or specific warnings See instructions for use Serial number Product code The product is compliant with the specifications of the Directive 93 42 CEE gt a fl e Servicing request For any information regarding the correct interpretation of the instruction manual the use maintenance installation and restore of the product please contact the Spencer Customer Care Service tel 0039 0521 541111 fax 0039 0521 541222 e mail service spencer it or write to Spencer Italia S r l Strada Cavi 7 43044 Collecchio Parma ITALY In order to facilitate the assistance service please always indicate the serial number SN shown on the label applied on the box or on the device 1 5 Demolition 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 the CE mark the serial number SN It must never be removed or covered 2 1 General warnings e The product must be used by trained personnel only having attended specific training for this device and not for similar products e Training routines must be registered on a special register in which the names of those trained of the trainers date an
16. rity and durability of the device The use of high pressure water should be avoided Water penetrates the joints and removes the oil creating the risk of corrosion of components Allow to dry thoroughly before storing Drying after washing or after use in wet environments must be natural and not forced do not use flames or other sources of direct heat 5 2 Maintenance 5 2 1 Precautionary maintenance The person who carries out the precautionary maintenance of the appliance user in person Manufacturer supplier or a third party has to guarantee the following basic requirements e Technical knowledge of the appliance and of the periodic maintenance procedures as described in these instructions e Specific qualifications and training in the maintenance operations of the appliance in question e The use of components replacement parts accessories that are either original or approved by the supplier in such a way that each operation causes no alteration or modification to the appliance e Possession of the checklist of operations carried out on the appliance e Guarantee complete adherence to the instructions of the Directive 93 42 CEE which includes also the obligation towards the Manufacturer to maintain post sales records and traceability of the appliance if requested The operator must always wear adequate personal protection such as gloves and mask etc during all checking and cleaning procedures Checks to be carried out before and
17. will accept no responsibility for the incorrect functioning and or damage caused by the use of any device which has not been repaired or certified on expiry date by the Manufacturer or by one of the Manufacturer s Authorised Service centres making void both the guarantee and the conformity to the Medical Devices Directive 93 42 CEE 6 ACCESSORIES AND SPARE PARTS There are nor accessories or replacement parts for these products ATTACHMENT A TRAINING REGISTER The product must be used only by trained personnel who have attended specific training for the use of this device and just for products with similar characteristics Keep this document at least 10 years after the end of life of the device Training date Training method user s manual during service former Trainer Operator s name Advanced training class etc ATTACHMENT B MAINTENANCE REGISTER 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 PERSON IN CHARGE OF SERVICE RESULT Operator Authorized centre Manufacturer KIND OF SERVICE Maintenance OPERATIONS MADE ON THE SERVICE DATE check DEV
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