Spencer SX Pick Up stretcher
Contents
1. User s Manual Spencer SX Pick Up stretcher ee 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 2 Operating instructions page 6 Warnings page 2 Maintenance and cleaning page 9 Product description page 5 Accessories and spare parts page 11 First edition 24 04 02 Rev 6 05 03 15 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 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 General or specific warnings Ba See instr2. each other both at the foot end and at the head end Check also that the length adjusting mechanisms are correctly blocked The correct alignment of the cervical rachis and the vertebral column must be maintained The insertion of the two halves under the patient could be impeded or hampered by the ground underneath the patient or by clothes During the closure of the two halves of the device check that no parts of the patient or of his clothes are caught up Fig B Fig C Fig D Fig E Fig G Fig F During the closure of the two halves of the device check that no parts of the patient or of his clothes are caught up e Cover the patient with an isothermal sheet which should also be tucked around the patient s body e The patient should be fixed to the device bearing in mind that the support is only for temporary use previous to transfer to the correct type of support spinal board or vacuum mattress Lifting and transport of the device with the patient loaded must be carried out by at least two rescuers bearing in mind the maximum load that they are permitted to lift and the physical structure and condition of the operator If the Pick Up stretcher is lifted from the head foot area the resistance to flexion of the stretcher decreases for this reason we advise to lift the Pick Up stretcher from the sides fig H Owing to the structural characteristics of this kind of stretcher we do not advise to keep a trauma patie
3. The joint has not been completely Lengthen the stretcher more until the exposed joints are completely exposed bend up to close for storage Lengthen the stretcher more until it The extension for the lower limbs does There are no holes to block the hinge ee not Put the device out of service and block at the desired length Blocking system is broken i contact the Assistance Center The supporting profiles turn around the Put the device out of service and Fixing rivets are broken borders contact the Assistance Center Put the device out of service and Damage to the structure Improper use contact the Assistance Center 5 MAINTENANCEAND 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 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
4. 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 after each use and at least every month are as follows e General functionality of the device e Cleanliness of the device remember that the failure of cleaning may cause the risk of cross infections e Absence of cuts holes tears on the structure including the straps e Correct fixation of all nuts bolts and screws e Correct fixation of straps e Correct fastening of straps e State of use moving parts belts e Integrity of components e Lubrication of moving parts e There are seat belts for the immobilization of the patient and they are intact and functioning e No piping or metal sheet present bends or cracks e Test the hooks closing them and opening them in succession e Check cleanliness of the hooks and the absence of extraneous parts to the mechanisms 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
5. choose an alternative path 2 1 Contraindications and side effects The use of this device if used as described in this manual does not present any contraindications or collateral effects 2 2 Physical requirements of the operators Spencer SX is a device destined to professional use only 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 stretcher e have a good muscular coordination The operators must be trained in efficient effective and safe patient transport Patient loading procedures for extremely heavy patients operations in rough terrain and in particular situations more Operators may be needed not only two as in normal conditions A tT The capacities of the various operators must be considered before determining their role in the employment of the stretcher 3 DESCRIPTION OF PRODUCT 3 1 Intended use The Pick Up stretcher is a device which enables the lifting and loading of a patient onto immobilising or transport devices such as spinal boards vacuum mattresses or transport stretchers It is essential for the loading trauma patients by two rescuers with use of this device patient can be picked up without changing position and the trunk and limbs can maintain the supine position while loading The structure and mechanism of the Pi
6. damage or abnormalities which could in any way influence the correct functioning 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 lot number place and date of purchase firs
7. 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 e General functionality of the device e Cleanliness of the device remember that the failure of cleaning may cause the risk of cross infections e Absence of cuts holes tears on the structure including the straps e Correct fixation of all nuts bolts and screws m a e Correct fixation of straps e Correct fastening of straps e State of use moving parts belts e Integrity of components e Lubrication of moving parts e There are seat belts for the immobilization of the patient and they are intact and functioning e No piping or metal sheet present bends or cracks e Test the hooks closing them and opening them in succession e Check cleanliness of the hooks and the absence of extraneous parts to the mechanisms 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 Loading the patient A correct medical evaluation should be made before the patient is moved lifted or transported Before loading the patient the stretcher must be positioned as close as possible to the patient Before proceeding with transport it is essential that the patient is fastened to the Pick Up stretcher using the bel
8. 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 must identify damaged worn parts but the replacement or restoration of 4 them can only be carried out by the manufacturer or or by an authorized service centre For other replacement repair activities contact the Manufacturer or an authorized centre Use only accessories original spare parts approved by Spencer Italia S r l otherwise we will accept no responsibility for the 5 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 Planned interventions by the Manufacturer or authorized center are not required but it is prescribed to make cleaning and checking indicated in the specific sections Cleaning and Precautionary Maintenance 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 repor
9. this may cause risks in terms of cross contamination We recommend the use of the polishing detergent Spencer STX 99 9 E E E 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 ofhigh 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 In the presence of blood oxidize it before to washing the device with water 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
10. cement 11 k 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 class etc Operator s name Basic training Advanced training r N Trainer 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 gt Manual Code and description of the device Purchase date Lot LOT or serial number SN Bought by PERSON IN KIND OF SERVICE CHARGE OF Maintenance OPERATIONS MADE ON THE RESULT SERVICE check DEVICE Operator extension of life span Authorized centre Manufacturer SERVICE DATE 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 S
11. ck Up stretcher offer maximum reduction of the movement required The Pick Up stretcher does not offer any type of isolation No action on behalf of the patient is expected 3 2 Main components n Description of component Materials 5 3 3 Models These models could be modified with reference to codes and or descriptions without any previous notification ST05001B Spencer SX R 3 baldes ST05002B Spencer SX R 2 baldes ST05040A Spencer SX F Fixed STOSOO6A Spencer SX grey ST05042A Spencer SX orange STO5043A Spencer SX red STO5041A Spencer SX green ST05012A Spencer SX blue ZS00412A Spencer SX black 3 4 Technical data Characteristics Spencer SX Spencer SX R Spencer SX F Height mm 70 70 70 430 Minimum lenght mm toe oeo o S 1intermediate lenght mm 3o 80 lintermediatelenght mm 190 F900 Saas Folded lenght mm 1190 1190 Weight kg o B O g d Load capacity kg 3 5 Reference standards Title of document MDD 93 42 CEE European Directive about Medical Devices 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 ISO 14971 Application of risks managing to medical dev
12. ered 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 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 lf 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 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
13. f the patient for particularly heavy patients for working on uneven ground or in special and unusual circumstances the presence of more operators is recommended not only 2 as expected under standard conditions e The maximum weight supported by each rescuer must comply with the requirements prescribed by the law of the land in the field of Health and Safety at Work e 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 functioning and safety of the device patient or operator it is necessary to replace the belts e Make sure the belts are properly fastened to the frame patient board of the stretcher e Always immobilize the patient using the straps supplied by the Manufacturer lack of immobilization may cause serious damage e Do not operate in case the weight has not been distributed correctly e Use the stretcher only as described in this user s manual e Do not alter or modify the stretcher arbitrarily to make it fit into the ambulance the modification may cause unforeseeable functioning and damage to the patient and operators In any case the warranty will be void e Paya lot of attention to possible obstacles water ice debris etc on the route of the stretcher chair because they could cause loss of balance of the operator and compromise the proper functioning of the device If the path free cannot be made free of obstacles
14. ices 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 CEI EN 62366 Medical Devices Application of the utilisation characteristics of engineering to medical devices 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 40 C Storage temperature from 20 to 60 C Relative humidity from 5 to 95 UNI CEI EN ISO 15223 1 4 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 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 Check that all the components
15. in this user s manual Maximum load Capacity means the total weight distributed according to the human anatomy In determining the load of the total weight on the 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 e Never leave the patient unassisted on the device because he may be injured e The device and all its components after washing should be allowed to dry completely before storing e Lubrication must be carried out after cleaning and complete drying e Follow the procedures approved by the Emergency Medical Service for the immobilization and transport of patients e Follow the procedures approved by the Emergency Medical Service for the positioning and transport of patients e Avoid contact with sharp objects e Make sure before lifting that the operators have a firm grip on the device e Avoid pulling the device on rough surfaces e Do not lift by crane or other mechanical lifters e Have practice with an empty stretcher in order to make sure you become familiar with the manoeuvres e The use of the device requires at least two operators in suitable physical conditions they must therefore be endowed with strength balance coordination and common sense and they must be trained on the proper operation of the device Spencer stretcher e For loading techniques o
16. nt on the Pick Up stretcher for any more time than essential or during ambulance transport and we advice to move and transport the patient on a spinal board or a vacuum mattress E _ 4 3 2 End of use Once the transport of the patient has terminated carry out the procedures described in paragraph regarding maintenance and cleaning before putting the device into storage The Pick Up stretcher should be reduced to its minimal size for storage by folding the upper half on top of the lower half e Open both of the side locks and pull out the two halves until the joints are exposed fig I and the Pick Up stretcher reaches its maximum extension before folding the stretcher fig L If the joints are not completely extracted the stretchers could be irreparably damaged e Place the Pick Up stretcher into its transport bag If the Pick Up stretcher is stored with its forks vertical and horizontal it must be shortened to its minimal length before being fixed to the fork 4 4 Troubleshooting PROBLEM REMEDY Put the device out of service and Il the lock The spring in the block is damaged without patient loaded l p Blocks are dirty Accurately clean blocks The extension for the lower limbs does Blocks are dirty Accurately clean blocks not lengthen shorten after unlocking Put the device out of service and Deformed profiles the lock contact the Assistance Center The extension for the lower limbs does ror
17. pencer 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 13
18. r or final user is 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 Spencer Italia S r l expressly disclaims any responsibility and or liability for your non compliance with the present regulatory provisions t 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 e 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 e 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 e Always respect the maximum load capacity of the device as indicated
19. t 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 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 In addition both public and private operators are obliged to inform the manufacturer of any measures that should be adopted
20. t 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 10 The device if used as indicated in the following instruction manual has an average life span of 5 years 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 both the guarantee and the conformity to the Medical Devices Directive 93 42 CEE 6 ACCESSORIES AND SPARE PARTS 6 1 Accessories STO5009A SX Bag Carrying case for Pick Up stretchers orange ST05010A SX Bag Carrying case for Pick Up stretchers blue ST05016A SXO Horizontal fixing system in aluminium for Pick Up stretcher ST05017A SXV Vertical fixing system in aluminium for Pick Up stretcher ST05018B SXV Vertical fixing system in aluminium for Pick Up stretcher 20G ST05019B SXO Horizontal fixing system in aluminium for Pick Up stretcher 20G STO5050B Ranger SX Foldable trolley for Pick Up stretchers transport ST00598A STX 598 Two pieces belt with plastic hook and orange belt ST00592A STX 592 Two pieces belt with metal hook and orange belt ST00500C Strap Up Belt cover blue 6 2 Spare parts ST05048A SX R Red Key Z5000 Plastic joint for repla
21. to make the steps necessary to guarantee the safety and the health of the patients and the users o any medical device As a distributor or end user 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 s 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 The distributo
22. ts supplied which will offer stability and safety The Pick Up stretcher is not indicated for immobilising or transporting for long periods distance e Start with the initial immobilising of the cervical area as prescribed by your standard area protocols e Position the Pick Up stretcher in the closed position as close as possible to the patient The lengthening of the top support profile should be reduced to a minimum and it should correspond to the head of the patient fig B e To lengthen the profile turn the side blocks e Lengthen the supporting profile for the lower limbs so that it corresponds with the patient heels and turn the side locks until you hear the locks close fig C e After checking that the locks are correctly closed and the length is correctly adjusted open the SPENCER SX RED KEY vertically and position them on the sides of the patient fig D e The operators should position themselves on the sides of the patient in the trunk area Move each half of the device and position them under the patient A minimum movement of a few centimetres in the shoulder and the hip area can be made in order to assist this operation fig E e In order to lock proceed first with the head lock and then the area of the feet making sure that the red lock is pushed in so that the two halves lock together correctly fig F Before moving the device with the patient loaded check that the two halves of the stretcher are correctly attached to
23. uctions for use Lot number REF Product code The product is compliant with the specifications of the Directive 93 42 CEE m m S J 1 4 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 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 The disposal of the accessories and the medical device shall be performed according to the current regulations in each country 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 lot number LOT It must never be removed or covered 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 e Training routines must be regist
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