User's Manual Boston Pro / Tec / Light Basket stretcher
Contents
1. The patient must always be assisted during all phrases of transport Fig N Fig O i i Z P 4 4 Troubleshootinc PROBLEM CAUSE REMEDY Put immediately out of service and Structural damage Improper use contact the service centre Damage to the patient plane spine board Put immediately out of service and Improper use integrated contact the service centre Improper use or operators not Put immediately out of service and adequately trained contact the service centre The Folding backrest not lock 5 MAI NTENANCE AND CLEANI NG 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 The board has been made out of incontaminable material in order to increase hygiene and easy cleaning 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 If the stretcher is not cleaned regularly this may cause risks in terms of cross contamination We recommend the use of the polishing2. Italia S r l otherwise we 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 5 2 2 Periodic maintenance There is not a periodic review 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 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 the guarantee and the
3. about medical devices and Directive 98 8 CE about the introduction of biocides onto the market 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 UNI EN 14155 Clinical evaluation of the medical devices for human beings Part 2 Clinical evaluation plans 3 6 Environmental conditions Functioning temperature from 10 to 50 C Storage temperature from 20 to 60 C Relative humidity from 5 to 95 With exceptionally high or low atmospheric temperature the patient s skin must be isolated in order to avoid direct contact with the stretcher OPERATING INSTRUCTIONS 4 1 Transport and storage Before transporting the appliance 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 d
4. 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 integrity 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 During all check
5. device if used as described in this manual does not present any contraindications or collateral effects 2 4 Physical requirements of the operators The Boston Stretcher series are devices intended for professional use The rescue operators must have the following minimum requirements e physical capacity for operating the device e be able to seize the device firmly with both hands e have strong back arms and legs for lifting pushing and pulling the trolley e have a good muscular coordination The operators must be trained in efficient effective and safe patient transport This stretcher requires the employment of at least two operators with sufficient strength balance coordination and common sense When loading extremely heavy patients operating on rough terrain and under other particular circumstances more operators may be needed not only two as in normal conditions The capacities of the various operators must be considered before determining his role in the employment of the trolley 3 DESCRIPTION OF PRODUCT 3 1 Intended use The Boston stretchers are designed for the rescue and transport of patients They can be used in any type of rescue operation particularly in difficult conditions where a standard stretcher cannot be used but the patient requires full protection against any possible bumps and bangs The stretcher does not in anyway require that the patient intervenes on the device ea H p 3 2 Main compone
6. particularly sloped surfaces is the responsibility of the operators involved and they must therefore be trained and capable to carry out this type of transport e The maximum loading weight indicated for each stretcher is stipulated considering the weight of the stretcher patient rescue equipment and where applicable the weight of the operator In such case the loading limit of each component of the rescue equipment must be equal at least to the maximum loading weight of the stretcher e During this type of operation the stretcher can hang horizontally or vertically Restrain the patient to the stretcher in such a way that he will not slide horizontally or vertically or out of the stretcher The belts used must be correctly attached to the indicated areas of the frame as shown in fig M for transport on inclined surfaces e Do not anchor the belts to any other areas as the correct balance of the stretcher would not be certain e For all types of transport reference to the user manual of the lifting device being used is obligatory e If the patient presents injuries to the limbs they must be immobilised with the correct device and the stretcher should not be used in the vertical position e The loading structure of the stretcher should always be fixed with additional ropes tapes see fig N and O so that the rescuer can position and manoeuvre the stretcher during the transport phrase and avoid any unexpected movement of the N stretcher
7. use could cause permanent damage to the backrest piston Fig G 4 3 4 Putting the patient on stretcher Do not move lift or transport the patient until medical assessment has been given e Before the patient is moved lifted or transported the primary medical assessment must be carried out once the diagnosis has been made where possible the patient should be encouraged to actively assist in being put onto the stretcher and at the same time he should be informed of all possible risks e Depending on the _ patient s condition on the atmospheric conditions and the rescue scenario the basket stretcher can be covered with a blanket which will offer more warmth and protection to the patient e The Boston series of basket stretcher is compatible with immobilising systems such as head immobilisers Boston Tec and Boston Light both have a seat for the spine board e If the patient is to be immobilised to the spine board follow the instructions for this type of use in Fig H the manual of the chosen immobilising device e Position the patient as close as possible to the stretcher before loading e Load the traumatised patient following the procedure stipulated by the emergency medical service e Restrain the patient using the restraint belts supplied with the product or with other Spencer approved restraint belts The best anchoring points for the belts are situated on the main structure of the basket stretcher and the areas indicated A
8. B C fig H e Check that the belts are not too tight Maintain the correct spinal alignment The attachment of any type of immobilizer under the patient could have some problems caused by the shape of the board or by the presence of clothes N h A 4 3 5 Lifting the stretcher with patient aboard Before transporting the patient he must be fixed to the basket stretcher using the purpose made belts that offer both stability and safety e Transport by hand requires the presence of at least two operators who should position themselves at opposite ends of the stretcher e If the load is high or the distance to transport is particularly high more operators are required e It is best to maintain symmetrical positioning for the operators which will help to maintain the maximum level of balance e Using the correct lifting technique which will reduce the effort the operators must grasp the opposite ends of the stretcher and then lift it 4 3 6 Vertical or extreme angle Transport Before carrying out any operation as such check that the paragraph 5 2 has been read and that all fixing and immobilising procedures have been carried out correctly and that the condition and injuries the patient presents are compatible with hoisting Neglect or the non compliancy could have fatal consequences e Considering the huge variety of possible rescue scenario the choice of the best immobilising system for vertical transport or transport on
9. Before each use check the integrity of the belts and their hooks as specified in the User s Manual In case of malfunction or damage that may compromise the function and safety of the device patient or operator it is necessary to replace the belts Make sure the belts are properly fastened to the frame of a stretcher Always immobilize the patient using the straps supplied by the Manufacturer or accessories belts lack of immobilization may cause serious damage Do not operate in case the weight has not been distributed correctly Always grasp the structure to lift and carry the stretcher Do not alter or modify the stretcher arbitrarily to make it your needs the modification may cause unforeseeable functioning and damages to the patient and operators In any case the warranty will be lost e Pay a lot of attention to possible obstacles water ice debris etc on the route of the trolley 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 e Condensation water ice and accumulations of dust can affect the correct operation of the device making it unpredictable and causing a sudden alteration of the weight that operators have to carry e Improper installation of the fixing device may cause structural damage and consequent injury to the welded front legs 2 3 Contraindications and side effects The use of this
10. SERVI CE check DEVI CE Operator extension of life span Authorized 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 11
11. User s Manual Boston Pro Tec Light Basket stretcher 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 I NDEX General information pag 13 Operating instructions pag 16 Warnings pag 13 Maintenance and cleaning pag 19 Description of product pag 15 Accessories and spare parts pag 20 First edition 29 05 13 Rev 0 29 05 13 Spencer Italia S r l Strada Cavi 7 43044 Collecchio PR ITALY Tel 39 0521 541111 Fax 39 0521 541222 E mail info spencer it Thank you for choosing a Spencer product a GENERAL I NFORMATION 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 Y General or specific warnin
12. amage and reduce safety characteristics A 4 2 Preparation On receipt of the product Remove the packaging and display the material so that all components are visible 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 Correct fixation of straps Correct fastening of straps State of use Integrity of components Welding is intact no cracks or breaks No piping or metal sheet present bends or cracks The backrest has no structural damages or fissures 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 4 3 1 Fitting Removal spineboard on the Boston Pro Press the button on the blocking system n 3 par 3 2 as demonstrated in picture and turn the parts until the board can be lifted Fig C e Lift the spinal board and move it out of the top safety catch n 1 par 3 2 4 3 2 Trendelenburg function Boston Tec and Boston Light The patient must always be inf
13. ch 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 the device received inform the Manufacturer immediately and avoid use of the device e Inthe 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 patien
14. conformity to the Medical Devices Directive 93 42 CEE 6 ACCESSORIES AND SPARE PARTS 6 1 Accessories ST04525B STX 537 Universal floatation one piece ST04518A STX 518 Universal floatation two piece ST04524B STX 538 Universal floatation three piece ST04519C STX 519 Adjustable lifting bridles ST04522B STX 540 Fixed lifting bridles ST04523B STX 542 pulling bridles ST04040A STX 40 Bag for basket STO4600B Speed basket mini ST04601B Speed basket mega FO1049B TRACK 5 IV pole 6 2 Spare parts STO2010B Rock Pin yellow Spine board ST70002A STX 702 two pieces reflex metal belt 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 Training date Training method user s manual during service Trainer former class etc Operator s name Basic training Advanced training 10 ATTACHMENT B MAINTENANCE REGISTER T 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 KI ND OF SERVI CE CHARGE OF SERVICE DATE Maintenance OPERATI ONS MADE ON THE RESULT
15. determining the load of the total weight onthe product the operator must consider the weight of the patient the equipment and the accessories Moreover the operator must consider that the overall dimensions of the patient do not reduce the functionality of the device Never leave the patient unassisted on the device because he may be injured The device and all its components after washing should be allowed to dry completely before storing Avoid contact with sharp objects Do not use the device if it is pierced torn or frayed Make sure before lifting that the operators have a firm grip on the device Avoid pulling the device on rough surfaces The device is a stretcher for patients transport and cannot be used as a stationing device First practice with an empty stretcher in order to get used to the way in which the trolley manoeuvres For the use of the device at least two operators in suitable physical conditions are needed they must therefore have strength balance coordination and common sense and must be trainedon the correct functioning of the device Spencer trolley For techniques for loading particularly heavy patients for rescue operations on steep ground or in unusual circumstances it is recommended the presence of more operators not just two as required under standard conditions The maximum weight sustained by each rescuer must comply with requirements prescribed by the law of the Country concerning Health and Safety at Work
16. ed the assistance of qualified staff must be guaranteed 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 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 use
17. emed 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 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 Medical Device Directive 93 42 CEE Always respect the maximum capacity of the device as indicated in this user s manual Maximum load capacity means the total weight distributed according to the human anatomy In
18. g See instruction for use Lot number il LoT Serial number Product code C The product is compliant with the specifications of the Directive 93 42 CEE 1 4 Servicing request 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 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 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 Labeling 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 or 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 and place are indicated This register whi
19. ing 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 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 wheels belts Integrity of components State of use Welding is intact no cracks or breaks No piping or metal sheet present bends 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 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 The person responsible for routine maintenance can identify damaged worn parts but the replacement or restoration of 4 them can only be done by the manufacturer or or by an authorized service centre Use only accessories original spare parts approved by Spencer
20. nts Boston PRO Fig A Boston TEC LIGHT Fig B n Description of component Safety superior upper locking for Spencer Rock Pin Spine board Rock Pin Anchorage system for spineboard Backrest piston S 4 Backrest piston 6 Lever for Trendelenburg selection and reset 8 Folding backrest S O 3 3 Models This model could be modified with reference to codes and or descriptions without any previous notification ST04302B BOSTON PRO ALUMINIUM BASKET STRETCHER WITH ROCK PIN SPINE BOARD ST04303B BOSTON PRO STEEL BASKET STRETCHER WITH ROCK PIN SPINE BOARD ST04304B BOSTON PRO TITAN BASKET STRETCHER WITH ROCK PIN SPINE BOARD ST04310B BOSTON TEC ALUMINIUM BASKET STRETCHER ST04311B BOSTON TEC STEEL BASKET STRETCHER ST04312B BOSTON TEC TITAN BASKET STRETCHER ST04320B BOSTON LIGHT ALUMINIUM BASKET STRETCHER ST04321B BOSTON LIGHT STEEL BASKET STRETCHER ST04322B BOSTON LIGHT TITAN BASKET STRETCHER 3 4 Technical data Characteristics Boston Pro Boston Tec Boston Light Length mm 2110 2110 2110 Width mm Height mm Weight kg Steel Aluminum Titan 26 17 9 23 12 8 22 11 7 Load capacity kg LANN The maximum loading weight includes the weight of stretcher patient equipment and rescuers CE 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 Directive 93 42 CEE MDD 2007 47 CEE
21. ormed before any adjustments are made Models Boston Tec and Boston light permit the slope adjustment of the lower part of the patient board in addition to horizontal position three other gradients are available thanks to the Trendelenburg function To use this function lift the lever n 6 par 3 2 Lift the board to the requested height Check that the board is in a stable position 4 3 3 Adjusting the backrest Boston Tec and Boston Lignt The patient must always been informed before any adjustment is made Changing backrest inclination from horizontal to vertical position Lift until the first position is reached The backrest will automatically lock Proceed in the same way to the next position checking each time that the locking system is correctly engaged each time In addition to the horizontal position another seven positions are available fig F Changing backrest inclination for vertical to horizontal position Hold the backrest with one hand to avoid any unexpected movement and release the weight by moving the backrest upwards At the same time action the knob on the backrest piston n 4 par 3 2 pulling it upwards until the locking mechanism is released following which the backrest can be lowered down to the desired position or back to the horizontal with the help of the other hand Release the knob fig G There are seven positions Take care to release the weight off the backrest before actioning the lever Incorrect
22. rs of any medical device As a Distributor or End Users of products manufactured and or marketed by Spencer Italia S r l you 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 conformity of the products to the regulations in the relevant territory 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 specifications 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 de
23. t and or of the user are detected the device must be immediately removed from service and the Manufacturer must be contacted e f 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 e Use of the device in anyway other than described in this manual is forbidden e Do not alter or modify in any way the appliance any such interference could cause malfunctions and injury to the patient and or rescuer e 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 e 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 e Handle with care e 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 k 2 2 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 us
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