User`s Manual WIV / Air WIV IV subministration bags
Contents
1. or End Users 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 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 dama2. 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 The device does not require periodic maintenance by the manufacturer however the routine maintenance must be guaranteed as indicated on paargraph 5 2 1 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 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 conformity to the Medical Devices Directive 93 42 CEE 6 ACCESSORIES AND SPARE PARTS There are no accessories or replacement parts for this device 14 ATTA
3. CHMENT A TRAINING REGISTER D The product must be used by trained personnel only having attended specific training for this device and not for similar 0 products X Keep this document at least 10 years from the end of life of the device TALE cene Training method user s manual during service former class etc Operator s name Trainer Basic training Advanced training 15 ATTACHMENT B MAINTENANCE REGISTER n Keep this document at least 10 years from the end of life of the device AN Perform the required maintenance and to respect the life span of the device as indicated by the Manufacturer in the User s Manual Code and description of the device Purchase date Lot LOT or serial number SN Bought by PERSON IN KIND OF SERVICE CHARGE OF SERVICE DATE Maintenance OPERATIONS MADE ON THE RESULT SERVICE check DEVICE Operator extension of life span Authorized centre Manufacturer 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
4. User s Manual WIV Air WIV IV subministration bags WIV Air WIV 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 10 Operating instructions page 13 Warnings page 10 Maintenance and cleaning page 13 Description of product page 11 Accessories and spare parts page 14 First edition 26 09 05 Rev 3 05 07 12 Spencer Italia S r l Strada Cavi 7 43044 Collecchio PR ITALY el 1 5 39 05271 nfommenencer it 521 541111 Fax 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 t i General or specific warning See instruc
5. ators 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 the device received inform the Manufacturer immediately and avoid use of the device e 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 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 e 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
6. ceability 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 e General functionality of the device Cleanliness of the device remember that the failure of cleaning may cause the risk of cross infections Presence of cuts holes abrasions Integrity of pump Pump seal Integrity and functionality of manometer 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 or or by an authorized service center 13 gt 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
7. ces labelling Information supplied by the medical devices manufacturer Medical Devices Application of the utilisation characteristics of engineering to medical devices Guideline for the classification Technical Documentation Clinical Data of medical devices Medical Devices vigilance system Clinical evaluation of the medical devices for human beings Part 2 Clinical evaluation plans 12 a al 3 6 Environmental conditions Functioning temperature from 0 to 40 C Storage temperature from 10 to 50 C Relative humidity from 5 to 95 4 OPERATING INSTRUCTIONS 4 1 Transport and storage Before transporting the appliance make sure that it is correctly packaged ensuring also that there are no risks of shocks bumps or falls during the transport itself Keep the original packaging for use in case of any further transport and for storage Damage to the appliance caused during transport and handling is not covered by the guarantee Repairs or replacement of the damaged parts are the responsibility of the client The device must be stored in a dry cool area away from direct sunlight It must not be placed in contact with any substances or chemical agents which could cause damage and reduce safety characteristics 4 2 Preparation On receipt of the product e Remove the packaging and display the material so that all components are visible e Check that all the components pieces on the acco
8. ges that 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 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 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 e 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 device must be immediately removed from service and the Manufacturer must be contacted e When the device is being used the assistance of qualified staff must be guaranteed Never leave an unassisted patient The presence of at least one operator is essential at all times when the medical device is in use The device not be exposed to or come into contact with any source of co
9. iance and when necessary clean the covering of the infusion pump with a damp sponge use only a mild detergent and water Avoid use of solvents and stain removers For disinfection use only products that have not corrosive or solvent action on the materials of the device Make sure to eliminate all traces of detergent which might damage or compromise the integrity and durability of the device 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 tra
10. ice must be immediately removed from service and the Manufacturer must be contacted e 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 e Use of the device in anyway other than described in this manual is forbidden e Do not alter or modify in any way the appliance any such interference could cause malfunctions and injury to the patient and or rescuer e 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 e 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 e Handle with care e 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 e 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 10 When the device is being used the assistance of qualified staff must be guaran
11. mbustion or inflammable agents Store in a cool dry dark place and do not expose to direct sun Do not store the device underneath any heavy objects which could cause structural damage Store and transport device in its original packaging Position and adjust the device taking care not to cause any obstruction to rescuers and or any other rescue equipment Use only with 500 and 1000 ml IV subministration bags Before each use check that the needle of the pressure gauge indicates zero After use open the air valve on the pump so that the needle of the pressure gauge indicates zero Do not exceed the maximum pressure allowed the device may be damaged 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 Intended use The devices have been made for IV infusion treatments The WIV and AIR WIV IV subministration bags have been studied for containing bags or IV infusions which can be squeezed thanks to the air chamber activated by a pump They are intended for use during the transportation of the patient but can also be usefully employed in hospitals clinics and medical surgeries The devices can be reused 11 Main components Main components WIV Polyurethane cover obtained by HFW Ring for fast attachment Manometer Cover for pressure shockproof rubber Pump with deflating valve PVC frontal window
12. mpanying 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 4 3 Functioning 1 Insert the IV infusion inside the device An eyelet placed in the upper part allows the IV subministration bag to be hung up 2 Compress repeatedly the pump until the pressure required is reached on the pressure gauge graduated in millimetres of mercury mmHg 3 To vary the pressure of the IV subministration bag operate either on the pump to increase the pressure or on the air valve to reduce the pressure Before each use check that the needle of the pressure gauge indicates zero After use open the air valve on the pump so that the needle of the pressure gauge indicates zero 4 4 Troubleshooting PROBLEM CAUSE REMEDY The device does not inflate The deflating valve is open Close the deflating valve on the pump The device deflates Possible leak of air Immediately put the device out of service and contact the service centre 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 all checking and cleaning procedures The IV subministration bag must not be immersed into water After use check the cleanliness of the appl
13. 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 16
14. teed 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 e With reference to the D Lgs 24 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 of any medical device e As a Distributor
15. tions for use ILOT Lot number SN Serial Number Product code C The product is compliant with the specifications of the Directive 93 42 CEE 1 4 Servicing requests For any information regarding the use maintenance and installation please contact the Spencer Customer Care Service on 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 or communicate 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 CE mark 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 indicated This register which will certify the eligibility of the oper
16. with nylon weft Rubber tubes 2 NN pwne gauge in NO U1 5 3 3 Models IFOO301A IFOO310B WIV IV subministration bag 3 4 Technical data Characteristics 3 2 2 Main components Air WIV 8 Nylon cover 9 Carabiner clip for fast attachment 10 Manometer elastic and 11 Pump with deflating valve 12 PVC frontal window 13 Rubber tubes 14 Air cha 9 12 14 10 13 11 Air WIV IV subministration bag with air chamber WIV mber in rubber Air WIV 250 x 15 x h375mm 170 x 15 x h380 mm Weight 200 g 300 g Nylon PVC rubber Nylon PVC rubber Air chamber Cover for pressure gauge Maximum pressure Ring for attachment 3 5 Reference standards Reference MDD 93 42 CEE MDD 2007 47 CEE UNI CEI EN 980 UNI CEI EN 1041 CEI EN 62366 MEDDEV 2 4 1a b NB MED 2 5 1 Rec 5 MEDDEV 2 7 1 MEDDEV 2 12 1 UNI EN 14155 250 mmHc Title of document 250 mmHc European Directive about Medical Devices Modifications to 90 385 CEE Directive about active implants 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 ISO 14971 Application of risks managing to medical devices Graphic symbols used for medical devi
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