combimatt-nexus ing.qxp
Contents
1. 2800A Combimatt Vacuum mattress double use Orange Blue QM22900A Nexus Vacuum Mattress Orange Blue QM22901A Nexus Vacuum Mattress Orange Blue with bag and vacuum pump Mod 120 3 4 TECHNICAL DATA Characteristics Combimatt Nexus Dimensions mm 2030x990 2020x850 Weight Kg 6 4 4 9 Superior covering Tarpaulin 600 D Tarpaulin 600 D Inferior covering Tarpaulin 700 D Tarpaulin 1000 D Separated chambers X X Internal Material Polystyrene spheres Polystyrene spheres Multi layer wooden support X n Nylon Handles 8 4 every side 8 4 every side Unidirectional Aluminium valve X X Characteristics Combimatt Nexus Pocket for Spinal Board X Antiretraction system x Tapered Distal X x X ray transparency X X High frequency welding X X Adaptable to Basket Stretcher x Compatibility Traction Systems X X Loading capacity Kg Max 150 Max 150 Weight limit for use without adequate supports Kg Max 15 Max 15 Colour Orange Blue Orange Blue Belts n 3 One piece Orange Derlin clip n 3 One piece Orange Derlin clip The device considering the materials used reaches the point of fusion at about 100 C 3 5 ENVIRONMENTAL CONDITIONS Both during use and warehousing the device must be used according to the temperatures and relative humidity hereunder Functioning temperature 10 C to 50 C Wareho2. Vacuum Mattresses Nexus Combimatt COMBIMATT This appliance conforms with the directi Guarantee of Quality system for the production and ve 93 42 CEE Medical Devices the final control of the products certified by the notifying body TUV Product Service GMBH INDEX General Information pag 2 Maintenance pag 7 Warnings pag 2 Accessories and replacement parts Description of Product pag 3 pag 7 Operating Instructions pag 4 Spencer Italia S r l Str Cavi 7 43044 Collecchio PR ITALY tel 39 0521 541111 fax 39 0521 541222 e mail info spencer it SP 07 023 1U REV 0 18 07 08 www spencer it Thank you for choosing a Spencer product 1 GENERAL INFORMATION eee 1 1 AIM AND CONTENTS The aim of this manual is to supply all the information necessary so that the client apart from attaining an adequate use of the appliance 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 with the product 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 See instructions for use 1 4 SERVICING REQUESTS For any information regarding the use maintenance and insta
3. decompression If the problem continues to exist take the device out of service and contact the assistance centre Take the device out of service immediately and contact the assistance centre No decompression of the device The device does not adapt to the patient s shape Inefficiency of the pump or use breakage of the connecting system between the valve and the device surface Non conform material Limited flexibility Take the device out of service immediately and contact the assistance centre Take the device out of service immediately and contact the assistance centre Damage holes cuts damages to the external structure Improper use or warehousing Take the device out of service immediately and contact the assistance centre 5 MAINTENANCE AND CLEANING 5 1 CLEANING Clean the exposed parts using flowing water a sponge and delicate cleaning liquid then dry with a soft cloth Do not use high pressure water Do not put in the washing machine Do not use instruments or liquids like metal sponges aggressive degreasers or dissolvent toluene cilene acetone Do not use strong acids or bases Not cleaning the device regularly might create the risk of cross contamination because of the presence of body liquids 5 2 MAINTENANCE 5 2 1 Precautionary Maintenance No programmed maintenance operations are needed Please remind regular cleaning as prescribed in paragraph 5 1 and the verificati
4. e when the device is in use The device may not be exposed to or get in direct contact with any type of heat source or inflammable agents In case of anomalies or damages which may compromise the functionality and the safety of the device the device must be taken out of service imme diately Pay maximum attention to possible obstacles on the route of transport of the device During transport make sure the patient s hands feet or other body parts are inside the device in order to avoid bumps or shocks that may cause lesions Make sure to have taken all precautions in order to avoid any direct contact with blood or body fluids The device is pressurized and therefore influenced by environmental pressure 2 3 PHYSICAL REQUIREMENTS OF THE OPERATORS Vacuum mattresses may be used in professional environments only The operators working with the device mush possess the following mini mum requirements suitable manuality in order to grab the device firmly with both hands robust back arms and legs for moving the device good muscular coordination and physical capacities Operators must be trained in efficient and safe patient transport For this device at least two string balanced and well sensed operators are needed For patient transport loading and unloading in case of par ticularly heavy patients rough terrains or particular and unusual conditions more operators may be needed The capacities of every operator must be considered be
5. ering 4 Transport handles 5 Internal channels which contain Polystyrene spheres Combimatt Spaccato Interno Nexus The devices are made out of a PVC covering with 5 longitudinal channels containing the polystyrene spheres which are the functional part in obtaining a rigid structure during decompression The external covering in Nylon has a protective function in case of direct contact with various terrains In the external structure outside the patient immobilization surface eight carrying handles are to be found which allow easy and safe patient transport On the two sides there are also mounted various buttonholes for the fixation of the safety belts The air evacuation takes place though a connecting tube between the metal decompression valve and a suction unit manual or electric vacuum pump Combimatt optimises the patient s comfort with the expanded closet cell polyethylene mattress indestructible with limited weight and pla ced in the apposite pocket The pocket mainly used for the mattress may be used for rendering the structure more rigid by inserting a spinal board Nexus has a reinforced inferior part for two third of the total length by two light and rigid marine multi layer panels in order to guarantee apart from the real immobilization and antiretraction spinal alignment support The distal inferior area can be shaped in order to optimise the immobilisation of eventual fractures of the lower limbs 3 3 MODELS QM2
6. fore determining his role in the use of the device 2 4 CONTRAINDICATIONS AND SIDE EFFECTS The use of this device if used as described in this manual does not present any contra indications or collateral effects DESCRIPTION OF PRODUCT 3 1 INTENDED USE Vacuum mattresses NEXUS and COMBIMATT are patient immobilizing devices in case of suspected traumatic lesions particularly useful for persona lized immobilizations referred to particular pathologic positions The vacuum system allows different grades of immobilisation from the most rigid one which allows a correct positioning of the patient to the more soft ones which allow the absorption of low frequency vibrations very common on emer gency transport vehicles Optimal mechanic immobilisers and thermal and electric isolates highly adaptable The NEXUS mattress allows a decompression of the structure without as less deformation as possible in the thorax area thanks to the presence of a wooden structure which guarantees the dimensions and the quality of the immobilisation COMBIMATT thanks to a pocket with an expanded high densi polyethylene mattress can actually be used as a stretcher mattress The same pocket can be used for rendering the mattress more rigid and the transport more safe and efficient by inserting a spinal board The pocket can be closed with a strap system 3 2 MAIN COMPONENTS 1 Aluminium decompression valve 2 Superior covering with longitudinal channels 3 External cov
7. llation please contact the Spencer Customer Care Service on 0039 0521 541111 Fax 0039 0521 541222 e mail info spencer it or write to Spencer Italia S r l Strada Cavi 7 43044 Collecchio Parma ITALY In the case of any doubts as to the correct interpretation of the instructions please contact Spencer Italia S r l for any necessary clarifications 1 5 DEMOLITION Follow the current regulations 1 6 LABELLING The serial number as indicated below can be found on each appliance and must not be removed or covered In order to facilitate assistance please indicate or communicate the lot number LOT on the label WARNINGS 2 1 GENERAL WARNINGS Before carrying out any kind of operation on the appliance 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 In the case of any doubts as to the correct interpretation of the instructions please contact Spencer Italia Srl for any necessary clarifications Regularly check the appliance Carry out the prescribed maintenance in order to keep the appliance in good condition and to guarantee correct func tioning and a long life In the case of any abnormalities or damage to the appliance which could jeopardize the functioning and the safety the appliance must be immedia tely removed from service Do not alter or modify in any way the appliance any such interfere
8. mpression compression pump Mod 125 QM22125A Transport bag for Nexus Vacuum Mattress Orange PVC QM22902A STX597 one piece orange belt Derlin closure ST00597A Repair Kit Various sizes of covering material and glue QM22199A 6 2 SPARE PARTS DESCRIPTION CODE Decompression valve QM22051A Repair element PVC Orange QM22198A Warning The information contained in this document can be modified without warning and is not to be intended as a commitment on the part of Spencer Italia S r l Spencer products are exported to many countries in which the same identical regulations do not exist It is for this reason that there can be many differences between the description and the actual product delivered Spencer works continuously to reach the perfection of all the models sold We therefore hope to have your understanding if we reserve the right to modify the shape equipping lay out or technical aspects that are herein descri bed at any given time Copyright Spencer Italia S r l All rights reserved No part of this document must be photocopied reproduced or translated into another language without the written approval of Spencer Italia S r l
9. nce could cause malfunctions and injury to the patient and or rescuer The appliance must not in any way be tampered with in such cases all responsibility will be denied for any malfunctions or eventual injuries caused by the appliance itself Who modifies or has modified prepares or has 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 Ensure that all the necessary precautions are taken in order to avoid hazards that can arise as the result of contact with blood or body fluids Handle with care 2 2 SPECIFIC WARNINGS The device may be used by trained personnel only It is recommended to try the device without any patient before actually using it to be sure to have acquired familiarity with the various manoeuvres At least two physically suitable operators are requested for the use of the device It is not possible using only the device to lift significant weights gt 15 kg and maintain guarantees for good stability and indeformable support Before every transport and or movement it is absolutely necessary to assure the patient on the device with use of the apposite belts After that the patient device combination has to be fixed to the stretcher with at least two safety belts Do not operate if the weight is not distributed correctly Do not leave the patient without assistanc
10. ons of functionality before and after every use 5 2 2 Servicing Maintenance The person to whom the servicing of the appliance is entrusted must guarantee the following basic requirements adequate knowledge of the appliance of its technical construction features of checks and final tests of packaging conservation and handling adequate knowledge of the technology used in the making of the appliance knowledge of the functions of the appliance of any potential risks and of the probability of possible malfunctions or break downs to be in possession of all the instruments necessary for carrying out any kind of technical operation regarding servicing to be in possession of original replacement parts or those authorized by the manufacturer specialized technical personnel trained by the manufacturer for the servicing of the appliance in question guarantee complete adherence to the instructions of the 93 42 CEE Directive also regarding the obligation towards the manufacturer to allow the aforementioned a post sales care and traceability of the appliance when requested The device if used as described in the following instructions has a life span of 5 years 6 ACCESSORIES AND REPLACEMENT PARTS 6 1 ACCESSORIES DESCRIPTION fefe 5 ABS pump Mod 109 with double effect piston QM22109A Aluminium decompression pump with Spencer logo Mod 120 QM22120A Aluminium decompression pump NO Spencer logo Mod 120 QM22121A Aluminium deco
11. se of the handles If all conditions have been respected the device may be considered ready for use 4 3 FUNCTIONING In extreme situations and difficult tracks a third operator is recommended The rescuer placed close to the head of the patient is responsible for the development of the recovery operation gives the orders and coordinates his colleagues Place the device as close as possible to the flank of the patient and verify the internal spheres are distributed in an uniform way all over the struc ture If the terrain is not coherent or presents rocks or openings place the device on the loading stretcher Load the patient on the device according to standard manoeuvres or with help of loading instruments scoop stretcher Fig A Place the patient l on the device with the feet pointing towards the decompression valve Fig B The heels of the patient must go over the border in this way it is possible to avoid compression of the vertebral column during decompression when the device shortens Fig B Before starting the decompression shape the device according to the patient paying particular attention to immobilizing head shoulders body and inferior limbs Fig C Shape the device in order to obtain a suitable shape for blocking any nertial movement of the patient The containment manoeuvre must be kept during the entire decompression procedure Make sure the device closes well around the patient and that the decom pres
12. sion does not cause any movement Fig C Fig C Controlling the immobilization of head and shoulders is one of the most important things make sure there is a good adherence and control very well the retraction Fig D It is recommended to place a weight behind the head of the patient for example operator s knee during decom pression Shape the device accurately according to the patient without blocking head and feet in order to avoid compression of the vertebral column during transport The first phase of decompression may be performed with an electronic vacuum pump but the final part should be perfor med with a manual pump Make sure the valve is accessible at any time also during transport Is it recommended to expose it before loading and transporting the patient Fig E Fig E nb Once the requested pressure is reached close the valve and detach the vacuum pump In particular situations with height variations significant increase it is recommended to keep the vacuum pump connected to the device for adjustments Fig F Fig F 4 4 TROUBLESHOOTING PROBLEM The device hardens during height decre ment The device looses decompression and tends to go back towards environment pressure CAUSE Variation of the relative pressure Deteriorated valve Possible holes in the inter nal chamber REMEDY Check the real state of pressure of the device by opening the valve or proceeding with ulterior
13. use temperature 20 C to 70 C in environments without risks for perforations and abrasions Relative Humidity 15 90 4 OPERATING INSTRUCTIONS 4 1 TRANSPORT AND STORAGE Fold the device making sure the internal spheres are well distributed all over the structure then slightly decompress in order to reduce size and maintain the uniform sphere distribution Before transporting the device make sure it has been packed adequately and there is no risk of shocking and falling during transport Conserve the original packaging for eventual transport Damage caused during transport and movement are not covered by warranty Repairs or substitutions are on charge of the Customer Stock the device in a dry place During warehousing do not place any heavy objects on top of the device The device is not to be considered a support in any way 4 2 PREPARATION When receiving the product remove the packaging a dispose all material in a visible way make sure all components and accessories described in the transport list are present Before every use the device must be checked completely in order to determine anomalies in functioning and or damages caused by transport and or warehousing Therefore before every use check general integrity of the device absence of cuts damages or hole on the covering connection between the device and the unidirectional valve state of use and held of the belts if present held and state of u
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