User's Manual Mini Matt Paediatric vacuum mattress
Contents
1. 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 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 the them can only be done by the manufacturer oror by an authorized service center Use only accessories original spare parts approved by Spencer Italia S r l otherwise we will accept 5 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 Planned interventions by the Manufacturer or authorized center a2. Fig C Before starting the decompression phase you must shape the device to suit the patient making sure that head shoulders pelvis and lower limbs are correctly immobilised fig D Shape the device to block any inertial type of movement The containment manoeuvre must be maintained all the time of the decompression phase Check the effective adhesion of the support to the patient in all points making sure that the shrinking and hardening of the device causes no movement of the patient fig D AA Fig D The control on the part which immobilizes head and shoulders is very important it is essential that this part is set tight and at the same time that the decompression is well controlled fig E It is useful to apply some weight to the top of the device behind the head of the patient Knee of the rescuer resting on the ground during decompression Shape the device without restricting the area above head and below feet so as to avoid compression on the spine during transport The first phase of decompression can be done with a suction unit but the final part when the device is becoming hard must be carried out with the appropriate manual pump Fig E It is important that the rescuer has easy access to the valve at any time during transport It is recommended to expose it before loading and transporting the patient fig F Vy Fig F a i When the desired is obtained close the valve and disconnect the decompr
3. for stretchers and other patient transport equipment on ambulances UNI EN ISO 14971 Application of risks managing to medical devices Medical devices Symbols to be used with medical device UNI CEI EN ISO 15223 1 labels labelling and information to be supplied 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 Clinical evaluation of the medical devices for human beings UNI EN 14155 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 15 to 90 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
4. 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 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 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 The rescuer at the head end of the patient is responsable for the recovery of the patient and is the leader of the service Position the device as close as possibile to the patient at the same time checking the uniform distribution of the granular material container inside the mattress If the ground is uneven the device must be placed on a stretcher Fig B Load the patient on the device using a suitable technique or using the appropriate instruments scoop stretcher fig B Position the patient so that the feet are placed by the decompression valve fig C The heels must be outside the border this avoids a compression of the spine during the aspiration of air which causes shortening of the length of the device
5. ACHMENT B MAINTENANCE REGISTER ith Keep this document at least 10 years from the end of life of the device h Perform the required maintenance and to respect the life span of the device as indicated by the Manufacturer in the User s Manual device Purchase date Bought by PERSON IN KIND OF SERVICE CHARGE OF Maintenance SERVI CE OPERATIONS MADE ON check THE DEVICE RESULT Operator extension of life Authorized span centre Manufacturer SERVICE DATE 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 12
6. PENCER User s Manual Mini Matt Paediatric vacuum mattress 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 8 Product description page 4 Accessories and spare parts page 10 First edition 07 05 13 Rev 0 07 05 13 Spencer Italia S r l Strada Cavi 7 43044 Collecchio PR ITALY VV AV VAV Ya Ne Tel 39 0521 541111 Fax 39 0521 541222 E mail info spencer it Thank you for choosing a Spencer product 1 GENERAL INFORMATION 1 1 Aim and contents The aim of this manual is to supply all the information necessary so that the client will not only attain adequate use of the appliance he will also be capable of using the instrument in the most autonomous and secure way possible This includes information regarding technical aspects functioning maintenance spare parts and safety 1 2 Conservation of the instruction and maintenance manual The instruction and maintenance manual must be kept together with the product for the whole life of the device inside a dedicated container and above all away from any substances or liquids which could compromise perfect legibility 1 3 Symbols used Symbol Meaning t General or specific war
7. eans 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 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 Do not wash in a washing machine device Do not use drying machines Avoid contact with sharp objects Do not use the device if it is pierced torn frayed or excessively worn out Make sure before lifting that the operators have a firm grip on the device Avoid pulling the device on rough surfaces Do not lift by crane or other mechanical lifters 2 3 Contraindications and side effects The use of this device if used as described in this manual does not present any contraindications or collateral effects 3 DESCRIPTION OF PRODUCT 3 1 Destination of use Versatile easy to use and to clean Thanks to the very limited dimensions it can be placed on every emergency vehicle because paediatric
8. ession device In particular situations where high excursions in altitude are possible substantial increase it is recommended to keep the suction device connected fig G 4 4 Troubleshooting PROBLEM The device stiffens as the altitude lowers The device tends to lose vacuum and regenerates internally the atmospheric pressure level The device will not decompress The device does not suit the patient s shape Lesions holes cuts abrasions to the external cover F 5 1 Cleaning Variation of relative pressure Deteriorated valve There may be holes in the internal chamber Either the pump or the connector to the device or the space between valve and device is worn out or broken The material of the device is not adeguate Limited flexibility Improper use Incorrect stockage MAI NTENANCE AND CLEANI NG Fig G REMEDY Check the real state of pressure of the device opening the valve or further decompressing it using the pump If the problem persists put the device out of use and contact the customer ser vice centre Put the device out of use immediately and contact the customer service centre Put the device out of use immediately and con tact the customer service centre Put the device out of use immediately and con tact the customer service centre Put the device out of use immediately and con tact the customer service centre Clean the exposed parts using water and a soapy s
9. he 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 2 2 Specific warnings e 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 in this user s manual Maximum load capacity m
10. immobilization must be done very quickly and perfectly The handles made out of non rotting polypropylene are soft and allow safe transport also if used as a transfer sheet The special tissue of the outside of the mattress protects it from damages caused by regular use and can be cleaned very easily 3 2 Main components 1 Bag made of 400 D nylon 2 Polypropilene handles 3 Self adherent strips closure 3 3 3 Models QM30161A Mini Matt These models could be modified with reference to codes and or descriptions without any previous notification 3 4 Technical data Dimensions mm 600 x 1300 Weight kg 2 2 Covering superior part Nylon 400 D Covering inferior part Nylon 400 D Two high frequency welded Internal pouch PVC are q y Internal material Polystyrene Temperature of use C 10 40 Temperature of stocking C 20 60 Aluminium one way valve X Handles 4 Radio compatible X HFW X Adapted for basket stretchers X Compatible with traction systems X Colour Orange 3 5 Reference standards Reference Title of document 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 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 1865 1 Directives
11. nings See instructions for use Lot number _ 5 be JEB Product code A M The product is compliant with the specifications of the Directive 93 42 CEE r P Servicing request For any information regarding the correct interpretation of the instruction manual the use maintenance installation and restore of the product please contact the Spencer Customer Care Service tel 0039 0521 541111 fax 0039 0521 541222 e mail service spencer it or write to Spencer Italia S r l Strada Cavi 7 43044 Collecchio Parma ITALY In order to facilitate the assistance service please always indicate the serial number SN 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 the CE mark the serial number SN or 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
12. 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 If the instructions belong to another device and not to the device received inform the manufacturer immediately and avoid use of the device 2 In case of any doubts about the correct interpretation of the instructions please contact Spencer Italia S r l for any necessary clarifications 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 damage or abnormalities which could in any
13. ponge or delicate detergent then dry with a soft flanel or leatherette cloth The use of high pressure water must be avoided Do not machine wash Avoid in any case cleaning products or detergents like metal sponges or blades aggressive solvents or oil detergents like toluene cilene acetone Do not use acids or strong basics Failure to carry out the correct cleaning routine could increase the risk of cross infection due to presence of body fluids and or residuals During all checking maintenance and cleaning procedures the operator must wear adequate personal protection such as gloves mask glasses etc 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 trolley is not cleaned regularly this may cause risks in terms of cross contamination 8 CE Z _ We recommend the use of the polishing detergent Spencer STX 99 Rinse thoroughly with warm water making sure that you have removed all traces of detergent which could degrade or compromise the integrity and durability of the device The use of high pressure water sho
14. re 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 span of 5 years 6 ACCESSORIES AND SPARE PARTS 6 1 Accessories QM22109A QMX 109 ABS pump for vacuum mattresses QM22120A QMX 120 Aluminium vacuum pump for vacuum systems QM22125A QMX 125 Aluminium vacuum pump for vacuum systems 6 2 Spare parts There aren t any spare parts for this device 10 H k 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 Trainingdate Training method user s manual during Advanced _service former class training etc Operator s name Trainer Basic training _ ATT
15. rs 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 to make the steps necessary to guarantee
16. 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 e 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 e The distributor or final user is aware that in t
17. uld 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 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
18. 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 first date of use date of checks name of use
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