User's Manual R-Max 10 G fixing system for stretchers
Contents
1. 12 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 lot number place and date of purchase first date of use date of checks name of users any comments When the device is being used the assistance of qualified staff must be guaranteed Do not store the device underneath any heavy objects which could cause structural damage2. of the patient Avoid contact with sharp objects Do not use if the device is excessively worn Avoid pulling the device on rough surfaces Condensation water ice and accumulations of dust can affect the correct functioning 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 13 3 DESCRIPTION OF PRODUCT 3 1 Intended use Spencer R Max is a fastening system that allows the complete stability of the transport device on the ambulance floor especially designed through three points in for the stretcher s fixation 3 2 Main components n Description of component Material Command handle Back plates Frame Front plates Locking front latch rod Fastening tab Fig A 3 3 Models These basic models could be modified with reference to codes and or descriptions without any previous notification ST42702C R Max certified 10 G fixing system for stretchers 3 4 Technical data Characteristics Width mm Length mm Height mm Weight kg 3 5 Reference standards Reference Title of document MDD 93 42 CEE European Directive about Medical Devices Modifications to 90 385 CEE Directive about active implants MDD 2007 47 CEE Directive 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
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4. 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 ISO 9001 Managing systems for quality requirements UNI EN ISO 9000 Managing systems for quality basis and vocabular UNI EN ISO 13485 Medical Devices Managing systems for quality Requirements for regulamentation requirements UNI EN 1865 1 Specification for stretchers and other equipment for patient s transport on ambulances UNI EN 1789 Medical vehicles and their equipment Ambulances UNI EN ISO 14971 Application of risks managing to medical devices UNI CEI EN 980 Graphic symbols used for medical devices labelling UNI CEI EN 1041 Information supplied by the medical 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 Clinical evaluation plans BS OHSAS 18001 Managing systems for safety and health at workplace 3 6 Environmental conditions Functioning temperature from 20 to 60 C Storage temperature from 20 to 60 C Relative humidity from 5 to 85 4 OPERATING INSTRUCTIONS 4 1 Transport and storage Before transporting the a
5. SPENCER User s Manual R Max 10 G fixing system for stretchers 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 TUV SUD Product Service GmbH INDEX General information page 12 Operating instructions page 15 Warnings page 12 Maintenance and cleaning page 17 Description of product page 14 Accessories and spare parts page 18 Prima emissione 07 11 08 Rev 1 21 05 12 Spencer Italia S r l Strada Cavi 7 Te HSY 5 4 5411711 Fay 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 manual The instruction and maintenance manual must be kept together with the product for the whole life of the device inside the specially provided container and above all away from any substances or liquids which could compromise perfect legibility 1 3 Symbols used Symbol Meaning T General or specific warning BA See instructions for use Lot number Product code C The produc
6. 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 24 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 In addition both public and private operators are obliged to inform the Manufacturer of any measures that should be adopted to make the steps necessary to guarantee the safety and the health of the patients and the users of any medical device 2 Specific warnings Establish a maintenance program and periodic testing identifying an reference employee The perso
7. iner Advanced former class etc training Operator s name Basic training ATTACHMENT B MAINTENANCE REGISTER TR Keep this document at least 10 years from the end of life of the device ON 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 KIND OF SERVICE SERVICE Maintenance OPERATIONS MADE ON THE DATE check DEVICE MBSE OPE TEM Authorized extension of life span centre Manufacturer 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 2
8. isposal 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 the device received inform the Manufacturer immediately and avoid use of the device e 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 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 e 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
9. l 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 be considered valid as it will no longer be compliant with the 93 42 CE Directive for Medical Devices and therefore there is the possibility that 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 authorisa
10. n 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 Medical Device Directive 93 42 CEE Never leave the patient unassisted on the device because he may be injured The device after washing should be allowed to dry completely before storing away from sunlight and direct heating sources The lubrication should be done after cleaning and complete drying Follow the procedures approved by the Emergency Medical Services for the immobilization and transport of the patient Follow the procedures approved by the Emergency Medical Services for the placement and transport
11. ning Failure to carry out the correct cleaning routine could increase the risk of cross infection The operator must always wear adequate personal protection such as gloves and mask etc during i all checking and cleaning procedures The metal parts that are exposed to external agents usually undergo treatment and or coating to better their resistance Exposed parts should be cleaned with a sponge soaked in a delicate detergent and dry with a soft duster or chammy leather For a shiny appearance we recommend the use of detergents or waxes used by car builders We recommend the use Spencer STX 99 polish code ST50000E on the metal parts Rinse thoroughly with warm water making sure that you have removed all traces of detergent which may deteriorate or compromise the integrity and durability of the device High pressure water cleaning systems should not be used water could penetrate in the junctions and eliminate the grease which would increase the risk of corrosion 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 instr
12. ppliance make sure that it is correctly packaged ensuring also that 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 Absence of cuts holes tears on the structure Proper tightening of the screws and bolts Status of wear moving parts Integrity of components Lubrication of moving parts Burst of spring The welds are intact no cracks or breaks No piping or metal foil has kinks 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 contac
13. t is compliant with the specifications of the Directive 93 42 CEE 1 4 Servicing requests For any information regarding the use maintenance and installation please contact the Spencer Customer Care Service on tel 0039 0521 541111 fax 0039 0521 541222 e mail info 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 or communicate the serial number SN or lot number LOT 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 CE mark lot number LOT 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 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 d
14. t the Manufacturer 4 3 Requirements of the emergency vehicle Spencer R Max has been designed for installation on the ambulance The vehicle should have the following characteristics e level tread surface e tead surface long and large enough to freely house the fixing system piano e to ensure proper use of the fixation system you should install it on an emergency vehicle meets the requirements specified in EN 1789 otherwise the manufacturer can not be held responsible for any failures or anomalies generated by the use of an unsuitable surface 4 4 Functioning 4 4 1 Fixing the hook to the ambulance platform 1 Position the hook on the ambulance platform in the point where it will be fixed 2 Through the holes in the hook mark the position for the holes Two back holes and four front holes must be made Position the plates under the ambulance platform so that the holes correspond with those already made Using TCEI M8 screws not included washers 8 and automatic blocking nuts M8 fig B fix all parts together There are many different possibilities for choosing the holes in order to facilitate the fixing operations ad 15 4 4 2 Fixing the stretcher to the R Max Fig B 1 Load the transport device into the ambulance following the standard procedure 2 The FA n 7 fig C rod of the stretcher will run over the hook until it attaches at the front to the fixing blocks n 5 fig C which will hold
15. tion 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 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 Warranty will be considered void in compliance with the Medical Device Directive 93 42 EEC 6 ACCESSORIES AND SPARE PARTS There aren t any accessories or spare parts for this device 18 ATTACHMENT A TRAINING REGISTER D The product must be used by trained personnel only having attended specific training for this device and not for similar products a _ Keep this document at least 10 years from the end of life of the device Training date Training method user s manual during service Tra
16. uctions 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 During all checking maintenance and cleaning procedures the operator must wear adequate personal protection such as gloves mask glasses etc Checks to be carried out before and after each use and at least every 3 months are as follows e General functionality of the device e Cleanliness of the device e Absence of cuts holes tears on the structure e Proper tightening of the screws and bolts 17 Status of wear moving parts Integrity of components Lubrication of moving parts Burst of spring The welds are intact no cracks or breaks No piping or metal foil has kinks or cracks The person responsible for routine maintenance can identify damaged worn parts but the replacement or restoration of the them can only be done by the manufacturer or or by an authorized service center The inspection frequency is determined by factors such as lega
17. with their hooks n 6 fig C which will close as the rod passes 3 The thrust block n 8 fig D which is at the back of the stretcher follows the path of the the hook guides which will guide it to the mouth of the dovetail plate n 9 fig D blocking it by the small piston n 10 fig D Fig C 4 4 3 Unlocking the stretcher from the R Max Ay Q Q it lay Se EL TEES el td g oa HV FSS ff y VA I p q fy iy Fig D 1 To unblock the device from the 10 G hook pull the handle comand n 1 fig E towards the operator as far as it will go and this will permit the hook and the piston to open 2 With the other hand grasp the frame n 11 fig E of the stretcher and pull it towards the operator so that the thrust block and FA rod will disengage from their seat The two operators should be performed at the same time 16 Fig E 4 5 Troubleshooting ad 40 CAUSE REMEDY The handle command has not Press button as far as possible been activated Immediately put the device out of service and contact the Service Centre The piston and the hook do not open up The stainless steel movement rod has been cut Immediately put the device out of Incorrect use or not adequately Damages to the structure l service and contact the Service trained staff Centre 5 MAINTENANCE AND CLEANING 5 1 Clea
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