User's Manual ENERGY Heat regulating bag for IV liquid
Contents
1. Before connecting the device check that the electrical circuit of the sanitary vehicle is conform and compatible with the connections of Energy e The operating temperature of the bag 38 C 4 C will be obtained in about 7 minutes at a room temperature of 18 C 3 C after inserting the connection into the emergency vehicle e The time required to reach the ideal temperature depends on the initial temperature of the IV liquid on the external temperature on the chemical composition of the liquid on the IV container and on the time that the device is connected to the power source of the ambulance e During use the Energy bag must be kept in the upright vertical position e The use of the device in atmospheric conditions other than those indicated could compromise the safety of the device e Energy is a heat regulating bag for the warming of IV liquids and must never be used to warm blood or plasma e Special precautions regarding EMC electromagnetic compatability must be taken before using this device and the device must be conform to all the specifications regarding the EMC conformity contained within this manual e Radio communication devices fixed and mobile could influence the correct functioning of the device e The device can be used for a maximum of 48 consecutive hours and no further 2 3 Contraindications and side effects The use of this device if used as described in this manual does not present any contraindication2. 5 cycle Not applicable 61000 4 11 lt 5 UT for 5 sec 22 ai Power frequency magnetic fields Power frequency 50 60 Hz magnetic fields shold be at leveli charatensiic of CEI EN 61000 4 8 the typicla location in a typical com mercial or hospital enviroment UT value refers to the power suppl Manual and Manufacturer s Declaration Electromagnetici Immunity EN 60601 1 2 2001 ENERGY is intended for use in an electromagnetic surrounding as follows The owner or end user of ENERGY must garantee that the device is Used under these conditions IMMUNITY test CEIEN 60601 Compliance level Electromagnetic enviroment guide Test Level i KONP 3 Vrms Portable and bobile RF communications equip ments should be used no closer to any part of the device including cables than the recommended separation distance calculated from teh equation appicable to the frequency of the transmitter Recommended separtion distance d 1 166xRADXFP 80 MHz 800 MHz d 2 333KRADQ P 800 MHz 2 5 GHz wher P is the maximun output power rating of the transmitter in watts A0 according to the transmitter manufacturer and d is the recommended separa tion distance in metres m PEE Wi W Field strength from fixed RF transmitters as deter a eee ae ia os GHz ous ne 4 5 GHZ mined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur i the vicinity of equipm
3. User s Manual ENERGY Heat regulating bag for IV liquid warming CE This appliance conforms with the Directive 93 42 CEE Medical Devices Guarantee of Quality system for the production and the final control of the products certified by the notifying body TUV SUD Product Service GmbH I NDEX General information page 12 Operating instructions page 15 Warnings page 13 Maintenance and cleaning page 19 Product description page 14 Accessories and spare parts page 20 First edition 20 12 00 Rev 7 18 01 13 Spencer Italia S r l Strada Cavi 7 43044 Collecchio PR ITALY WWW SPENCER It Tel 39 0521 541111 Fax 39 0521 541222 E mail info spencer it tet 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 manual The instruction and maintenance manual must be kept together with the product for the whole life of the device inside the specially provided container and above all away from any substances or liquids which could compromise perfect legibility 1 3 Symbols used Symbol Meaning General or specific wa
4. at might occur Therefore we expressly disclaim 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 Training routines must be registered on a special register in which the names of those trained of the trainers date and place are indicated This register which will certify the eligibility of the operators to use the Spencer device has to be kept for a period of 10 years after the disposal of the device itself This register will be made available to the competent authorities and or manufacturer if requested e Use only accessories spare parts that are original or approved by Spencer Italia S r l in order to carry out any operation without causing any alteration or modification to the device otherwise we assume no responsibility for the proper functioning or damage resulting from device to the patient or the operator and warranty and will be considered void according to the compliance to the Medical Device Directive 93 42 CEE Do not use the device if it eccessively worn out Avoid pulling the device on rough surfaces Use the device only as described in this user s manual This product can used only by trained medical staff
5. e incorrect functioning or any damage caused by a device that has not undergone regular revision 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 5 2 3 Special servicing Only the Manufacturer or centres with written authorisation are authorised to complete any special servicing operations For any operations that are not carried out directly by the Manufacturer but by an authorised centre we have to underline that a report regarding all operations carried out must be requested This will permit both Spencer Italia S r l and the end user to keep a log book regarding the operations carried out on the device The device if used as indicated in the following instruction manual has an average life span of 5 years The life Span can be expanded only following a general revision of the product that must be carried out by the Manufacturer or by a centre authorised by the Manufacturer Spencer Italia S r l will accept no responsibility for the incorrect functioning and or damage caused by the use of any device which has not been repaired or certified on expiry date by the Manufacturer or by one of the Manufacturer s Authorised Service centres making void the guarantee and the co
6. ent 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 rE _ 4 2 Preparation On receipt of the product Remove the packaging and display the material so that all components are visible Check that all the components pieces on the accompanying list are present The appliance must be checked before every use so as to reveal any working abnormalities and or damage caused by transport and or storage In particular check General functionality of the device Cleanliness of the device remember that the failure of cleaning may cause the risk of cross infections Absence of cuts holes tears on the structure Integrity of components power cable and plug Connection to a power supply of 12 V DC Integrity of fuse Integrity of internal carabiners Correct functioning of zippers 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 Remember that the plug of the device must be inserted in the power source of the vehicle and eee ae Sap please note that It takes about 7 minutes at a room temperature of 18 C 3 C to obtain the correct temperature of the bag 38 C 4 C The time necessary for the infusion liquid to reach the tempera
7. ent marked with the symbol non ionising radiation Note 1 at 60 MHz and 800 MHz teh separation distance for the higher frequency range applies Nota 2 This guideline may not apply in all situatinas Electromagnetic propagation is affected by absorption and reflection from strucures objects and peo Jle al Field strength from fixed transmitters such as base stations for radio cellularcordessi telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic enviroment due to fixed RF transmitters an electromagnetic site survey should be considerd If the measured field strength in the location in which he Energy is Used exceeds teh applicable RF compliance level indicated above additional measures may be necessary such as reorientation or relocating the Energy b Above the frequency interval 150 KHz 80 MHz the field intensity but be lower than 3 Wm Recommended separation distances between portable and mobile RF communications equipment and ENERGY EN 60601 1 2 2001 ENERGY is intended for use in an electromagnetic enviroment in which the radiated RF disturbances are controlled The end user or customer of the ENERGY can help prevent electromagnetic interference by maintaining a minimal distance between portable and mobile RF connunications equipment transmitters and the ENERGY as recommended below according to the maximum output po
8. f 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 r e 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 e Act with all due care and diligence and contribute to ensure conformity to general safety requirements of all devices marketed in the territory by providing final users with all necessary information for carrying out periodical checks on their devices as specified in the relevant User Manual 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 You are aware that in the event of any failure to conform to the above mentioned requirements you will be deemed fully responsible for all damages th
9. he 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 Spencer Italia S r l is always at your disposal to plan trainings on products 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 If the instructions belong to another device and not the device received inform the Manufacturer immediately and avoid use of the device 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 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 way influence the correct functioning and the safety of the device of the patient and or of the user are detected the dev
10. heck that the power source has been vehicle has gone flat correctly loaded and if necessary re load 5 MAINTENANCE AND 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 5 all checking and cleaning procedures Before completing any cleaning operations on the device make sure that all electrical components cable plug are adequately protected For correct storage carry out the following routine operations Clean the outside and the inside with a clean cloth using any type of disinfect on the market bactericidal germicidal with a clean damp cloth removing all residuals of the disinfectant and 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 componen
11. ice 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 being used the assistance of qualified staff must be guaranteed Do not
12. kaging indicates that the item should be disposed of separately The correct disposal of the item when use has terminated is defined and organised by the manufacturer The end user who has to proceed with disposal must therefore contact the manufacturer and follow the system and procedures the manufacturer has organised for the separate collection treatment and disposal at end of life The correct separate collection of the out of use device which will permit recycling treatment and destruction in an ecologically friendly manner and will contribute to avoiding possible negative effects on the environment and for health while privileging the reuse and or re cycling of the collected waste components Please note that the owner will be subject to administrative sanctions in case of unauthorised disposal of the item 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 or the serial number SN It must never be removed or covered rF h 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 Training routines must be registered on a special register in which the names of those trained of the trainers date and place are indicated This register which will certify the eligibility of t
13. lease 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 every day maintenance can substitute the spare parts indicated on paragraph 6 2 Spare Parts only if authorized by the manufacturer or by a centre authorised by Spencer Use only accessories original spare parts approved by Spencer Italia S r l otherwise we will accept no responsibility for the incorrect functioning and or damage caused by the use of any device which has not been repaired or certified on expiry date by the Manufacturer or by one of the Manufacturer s Authorised Service centres Warranty will be considered void in compliance with the Medical Device Directive 93 42 EEC r 5 2 2 Periodic maintenance The device must be serviced by the Manufacturer or by an authorised centre every year If above mentioned revision is not carried out the conformity to the Directive 93 42 CE for medical devices will no longer be valid therefore even though the CE mark if present it is possible that the device no longer answers all the requirements as indicated by the Manufacturer at purchase Spencer Italia S r l will take no responsibility th
14. nd Directive 98 8 CE about the introduction of biocides onto the market CEI EN 62366 Medical Devices Application of the utilisation characteristics of engineering to medical devices MEDDEV 2 4 1a b Guideline for the classification of medical devices CEI EN 60601 1 CEI 62 5 and all ones Medical electrical equipment Part 1 General requirements for recalled basic safety and essential performance Medcal electrical equipment Part 1 Medical electrical CEI EN 60601 1 2 equipment Part 1 General requirements for safety Collateral standard Electromagnetic compatibility NB MED 2 5 1 Rec 5 Technical Documentation MEDDEV 2 7 1 Clinical Data MEDDEV 2 12 1 Medical Devices vigilance system UNI EN 14155 Clinical evaluation of the medical devices for human beings Part 2 Clinical evaluation plans 3 6 Environmental conditions Functioning temperature from 20 to 40 C Storage temperature from 20 to 50 C Relative humidity from 30 to 70 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 cli
15. nformity to the Medical Devices Directive 93 42 CEE 6 ACCESSORIES AND SPARE PARTS 6 1 Accessories IFO3031A E tube isolating tube 6 2 Spare parts There aren t any spare parts for this device 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 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 10
16. omagnetic enviroment Guide ENERGY uses RF energy only for its internal functioning which means that its RF emission is very low and it is therefore unlikely to cause any interference with any other electrical appliances in the immedia te proximity RF Emission CISPR 11 ENERGY can be used in all enviroments including domestic and those directly con Harmonised Emissions CEI 61000 3 2 nected to a low tension public power sup l ply which is used to supply power to buil Voltage fluctuations flicker CEI AOL APRICARS dings for domestic purposes 61000 3 3 RF Emission CISPR 11 Manual and Manufacturer s Declaration Electromagnetic Immunity EN 60601 1 2 2001 ENERGY is intended for use in an electromagnetic surrounding as follows The owner or end user of ENERGY must garantee that the device is used under these conditions IMMUNITY TEST CEI EN 60601 Compliancy level Electromagnetic Test level enviroment quide Floors should be wood cement or ceramic tiles If the floors are Elettrostatic Discharge CEI EN 61000 4 2 6kV contact 6kV contact covered with a synthetic material 8kV air 8kV air the relative humidity should be 30 at the most Transitori veloci burst CEI EN 61000 4 4 SOT amenar Not applicable Sovratensione CEI EN 61000 4 5 1kV differential Not applicable ee 5 UT for 0 5 cycle Voltage dipsm short interuptions and voltage 40 UT for 05 cycle variations on power supply input lines CEI EN 70 UT for 2
17. rnings See instructions for use Lot number SN Serial number Product code CE The product is compliant with the specifications of the Directive 93 42 CEE p J N Information to the users in compliancy with comma 13 of the Italian F Legislative Decree n 151 of 25 July 2005 Fulfilment of the Directives 2002 95 CE Aa 2002 96 CE and 2003 108 CE regarding Reduction of the use of dangerous substances in electric and electronic equipments and the disposal of their wastes 5A Fuse Eora Rated voltage supplies E Isolation class ll 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 info 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 I nformation to the users in compliancy with comma 13 of the Italian Legislative Decree n 151 of 25 July 2005 Fulfilment of the Directives 2002 95 CE 2002 96 CE and 2003 108 CE regarding reduction of the use of dangerous substances in electric and electronic equipments and the disposal of their wastes The crossed dustbin symbol applied on the product or on its pac
18. s or collateral effects 3 DESCRIPTION OF PRODUC 3 1 Intended use Energy is a heat regulating bag for the warming of IV liquids The use of the device as an active source of heat is indicated for the prevention and treatment of hypothermia It is an ideal thermal container for emergency medicine services but can also be used in hospitals field camps or mountain areas It is compact and can be used both hung on the stretcher or in the ambulance as a bottle holder or inside other bigger containers Thanks to this bag the infusion liquids remain at a constant temperature and the IV liquids can be transported out of the ambulance for a short period 3 2 Main components The heating pouch has a front pocket for the electric power supply cable a transparent identity pocket for the logo a cable with plug and adjustable shoulder strap 3 3 Models This model could be modified with reference to codes and or descriptions without any previous notification IFO3030A Energy 3 4 Technical data 5A lamellar double bladed light brown Fuses l l present in the cigarette lighter plug Cigarette lighter DIN ISO 4165 l Energy is not an applied part The part that is attached to the device Type of applied part must be BF type IP degrees of protection Isolation class O 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 a
19. 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 and the users o any medical device As a Distributor or End Users o
20. ts 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 rs 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 e General functionality of the device in order to make this check the device should be attached to the power source of the emergency vehicle and after about 3 minutes on inserting your hand inside the bag you will feel that the warming process is proceeding 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 Integrity of components power cable and plug Connection to a power supply of 12 V DC Integrity of fuse Integrity of internal carabiners Correct functioning of zippers The inspection frequency is determined by factors such as legal requirements the type of use frequency of use environmental conditions during use and storage P
21. ture set by the operator depends on the initial temperature of the liquid on the external temperature on the chemical composition of the liquid and on the characteristics of the liquid container Disconnect the plug from the power Wind up the cable put it inside the front pouch and close the Zip Open the zip of the main compartment for the IV liquid and position the IV bag using the carabiner clips Open the buttonhole in the base of the bag and thread the connectors towards the outside Following this close the buttonhole with the eyelet Close the zip of the bag and proceed with the patient Make sure that the ENERGY bag is in the vertical position and that it is properly connected to the means of transport and in a position which is not prone to accidental bumps and bangs We advise the use of the E tube isolation tube 1FO3031A which wraps round the exit tube of the IV solution The device requires some particular attention regarding the EMC electromagnetic compatibility and should be used in conformity to the EMC information contained in this user s manual The use of portable and mobile radio systems may influence the functioning of the device Manual and manufacturers declaration Electromagnetic Emissions CEI EN 60601 1 2 2001 LLENERGYis intended for use int the electromagnetic enviroment specified below The owner or end user of ENERGY must garantee that the device is used under these conditions EMISSION TEST Electr
22. wer or the communications equipment Rated maximum output power of transmitter Separation distance according to frequency of transmitter m 80 MHz 800 MHz 800 MHz 2 5 GHz R d 1 166xRADQ P d 2 333xRADQ P For transmitters rated at a maximum output power not listed above the recomended separation distance d in metres m can be determined using the equation appli cable to the frequency of the transmitter where P is the maximun output power rating of the transmitter in watts W according to the transmitter manufacturer Nota 1 at 80 MHz to 800 MHz the separation distance for the highest frequency applies Nota 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflections from structures objects and people b 4 4 Troubleshooting PROBLEM REMEDY Check that the source of power of the emergency vehicle is compatible with that of the Energy No contact between the plug and Make sure that the metal elements of the the socket of the 12 V DC of the plug come into contact with the socket emergency vehicle correctly Un attach the cable and check the state of it If it results damaged the device must The source of power and Energy are not compatible Energy is not heating up Interruption of power source between emergency vehicle and device be put out of service and the Spencer Customer service contacted The battery of the emergency C
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