Spencer Spine Splint Extrication/spine immobilization device
Contents
1. 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 devices Medical devices Symbols for use in the medical device labels NI CEI EN ISO 15223 1 ne R 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 MEDDEV 2 7 1 MEDDEV 2 12 1 UNI EN 14155 Clinical evaluation of the medical devices for human beings Part 2 Clinical evaluation plans 3 6 Environmental conditions Functioning temperature from 0 to 40 C Storage temperature from 20 to 50 C Relative humidity from 10 to 50 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 handlin2. 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 For a correct device storage clean it as follows Clean by means of a clean cloth and bactericidal or germicidal disinfectant Rinse with hot water extend the device and leave it to dry in a parched environment free from humidity Keep clean the outward surface by means of a clean cloth Do note use chemical solvents 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 obligatio
3. 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 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 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 sp
4. User s Manual Spencer Spine Splint Extrication spine immobilization device 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 5 Warnings page 2 Maintenance and cleaning page 9 Product description page 4 Accessories and spare parts page 10 First edition 02 02 05 Rev 4 26 08 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 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 o General or speci
5. an 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 passed the life span expected by the Manufacturer 6 ACCESSORIES AND SPARE PARTS 6 1 Accessories There aren t accessories available for this device 6 2 Spare parts SROO210A Set of chin fore head strap SR00174A Transport bag for Spencer Spine Splint adult SR00185A Transport bag for Spencer Spine Splint paediatric 10 3 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 Operator s name Basic training Training date Advanced training e Training method user s manual during service former class etc Trainer ATTACHMENT B MAINTENANCE REGISTER i i Ti Keep this document at least 10 years from the end of life of the device Manual KIND OF SERVICE Maintenance OPERATIONS MADE ON THE check DEVICE extension of life span SERVICE DATE Warning RESULT t Perform the required maintenance and to respect the life span of the device as indicated by the Manufacturer in the User s PERSON IN CHARGE OF SERVICE Operator Authorized centre Manufacturer The infor
6. 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 distributor or final user is aware that in the event of any failure to conform to the above m
7. atomy 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 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 Do not wash in a washing machine device e Do not use drying machines e Avoid contact with sharp objects e Do not use the device if it is pierced torn frayed or eccessively worn out 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 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 3 DESCRIPTION OF PRODUCT 3 1 Intended use Spencer Spine Splint is an essential and modern extrication transport system for traumatised patients Particularly indicated for patient s immobilization from skull to basin when rescue operatio
8. cated 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 k 4 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 a
9. der patient gluteus limiting basin rotations and pressures over genitalia Fig H 8 Once finished positioning phase fasten ventral belts without tightening hard so as to concur to a good abdominal expansion and diaphragmatic ventilation Now fix the head aligning it correctly if necessary placing some suitable pillows under it Fig 9 Rescuers will provide maintaining head constantly immobilized the chin holder and frontal band fixed to limit patient mouth opening as much as possible Passing the chin holder under the collar and around patient jaw angle Spencer Spine Splint action in addition to collar will maintain vertebral column alignment Once finished fixing operations it is possible to mobilize the patient to the spine board using it as an inclined board to reduce injured structure solicitations Fig J 10 A good co ordinate and trained team take about 7 8 minutes to carry out these operations It is very important to reduce supports application times and garantee a good patient positioning to avoid to expose him to further risks during extrications and transports operations Fig K a cr k 4 4 Troubleshooting Coco e CAUSE REMEDY Closure is Closure is insufficient Closing system is worn out Put immediately the device out of The wooden supports inside have Wear and tear service and contact the service centre lost their functional characteristics 5
10. ecessary to create space behind patient s back To do that immobilize first vertebral spine of patient manually until alignment position Fig B 2 While two rescuers maintain this position a third one will move ahead the patient of approximately 5 cm applying a traction on his basin so as to obtain enough space to insert the support to avoid bending his vertebral spine Fig C 3 After that the third rescuer will apply Spencer Spine Splint partially closed from the bottom upwards placing first arm to help insertion Fig D 4 5 6 7 Once having fixed Spencer Spine Splint release cross belts from the top spread them to the extricator sides and open the ventral wings behind the patient Fix the belts starting from one of thorax ones Fig E To reach right position it is necessary to raise and align Spencer Spine Splint to the patient To be sure to have reached right position fast one of the thorax belts starting from the shoulder to opposite armpit While locking the first belt raise the extricator so that tension will not allow any movement Thus final position is reached Fig F Spencer Spine Splint cervical collar and fixing system to the spine board carry out symmetrical serrations so as to avoid causing damages to the patient Once locked second thorax belt it is necessary to check Spencer Spine Splint position Fig G To obtain correct position lock the cross belts passing them un
11. eing 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 to make the steps necessary to guarantee the safety and the health of the patients
12. entioned 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 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 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 3 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 in this user s manual Maximum load Capacity means the total weight distributed according to the human an
13. fic warnings BA See instructions for use m E Lot 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 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 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 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 indi
14. g 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 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 straps H Correct fastening of straps State of use belts cover sheets straps Integrity of sewing and cover sheets Integrity of components Integrity of splints apply light pressure on the centre of the device in order to check any breakages do not apply a flexion force higher than 12 kg 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 1 Sometimes to apply Spencer Spine Splint it is n
15. mation 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 12
16. n 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 d cleaning procedures Checks to be carried out before and 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 straps Correct fastening of straps State of use belts cover sheets straps Integrity of sewing and cover sheets Integrity of components Integrity of splints apply light pressure on the centre of the device in order to check any breakages do not apply a flexion force higher than 10 kg 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 must identify
17. nd 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 first date of use date of checks name of users any comments When the device is b
18. ns are performed in car the use of this device is crucial prior to loading the patient on a spine board To obtain an effective extrication it is necessary to optimise subsidies application times They will be applied in this order cervical collar extrication device spine board Trained and organized rescuers will be able to immobilize a patient correctly and extract him from any damaged vehicle in a short time Before being able to apply the immobilization protections for vertebral column it will be necessary to bring back the patient in aligned position Apply therefore a cervical collar of the suitable size 3 2 Main components Thorax belts Abdominal belts Thigh belts Rear support Nape pillows Forehead part 1 Chin holder Transport bag COND UM BWN SPENCER _ Fig A 3 3 Models These basic models could be modified with reference to codes and or descriptions without any previous notification SROO160A Spencer Spine Splint adult SROO190A Spencer Spine Splint medium SROO180A Spencer Spine Splint paediatric 3 4 Technical data Spencer Spine Splint Adult SRO0160A Medium SRO0190A Paediatric SROO180A Dimensions inside the bag mm 930 x 210 x 70 830 x 230 x 70 750 x 210 x 70 Dimensions open mm 850 x 580 x 15 750 x 500 x 15 680 x 440 x 15 Weight with bag and accessories kg 3 8 o 25 O 3 5 Reference standards Title of document MDD 93 42 CEE European Directive about Medical Devices
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