User`s Manual TRACK 4 Telescopic I.V. pole
Contents
1. Unroll the band n 4 surround the infusion bag or bottle and fix them by means of the Velcro strap 4 3 4 Closing the device 1 Slightly unscrew the nuts n 3 and close to the lowest position the various tubes 2 Lower profile until it is horizontal 3 Move to the left the aluminium tube n 2 4 4 Troubleshooting PROBLEM CAUSE REMEDY The I V pole is not dicular to the eae E Wrong assembly Disassemble and reassemble the device surface on which it has been applied Improper use or non adequately Put the device out of service and contact Damages to the structure trained personal 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 exposed metal parts are usually treated and or painted in order to increase their resistance Clean the exposed parts with water and delicate soap never use solvents or stain removers In the event of a possible disinfection use products that do not have solvent or corrosive action on the materials constituting the device In order to obtain a shine effect it is possible to use car waxes and creams We recommend the use of the polishing detergent Spencer STX 99 Rinse thoroughly wi2. from 20 to 60 C A 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 remove the packaging display the material so that all components are visible and check that all the components pieces on the accompanying list are present The appliance must be checked before every use so as to reveal any working abnormalities and or damage caused by transport and or storage In particular check e General functionality of the device Cleanliness of the device remember that the failure of cleaning may cause the risk of cross infections Absence of cuts holes tears on the structure Correct fixation of all nuts bolts and screws State of use Integrity of components No tube or metal sheet present bends or cracks If the above conditions are met the device may be considered rea
3. 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 6 1 Accessories There aren t any accessories for this product 6 2 Spare parts IFOO207A Support strap IFOO204A Upper part I V pole IF00208A Nylon hook 4 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 Training date Training method user s manual during service former class etc Operator s name Trainer Basic training Advanced training ATTACHMENT B MAINTENANCE REGISTER iT i T Keep this document at least 10 years from the end of life of the device T Perform the required maintenance and to respect the life span of the device as indicated by the Manufacturer in the User s Manual KIND OF SERVICE Maintenance OPERATIONS MADE ON THE check DEVICE extension of life span SERVICE DATE Warning RESULT PERSON IN CHARGE OF SERVICE Operator 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 ex
4. 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 Manual Actively contribute to product safety checks on products sold by communicating any relevant risk analysis information both to the Manufacturer and to any competent authorities so that the necessary action can be promptly taken 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 that might occur Therefore we expressly disclaim any responsibility and or lia
5. 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 store the device underneath any heavy objects which coul
6. Do not use the device if it excessively worn out 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 telescopic I V pole Track 4 is a robust and practical I V pole made of aluminium which can be fixed to the stretcher easily When not in use the I V pole is folded and fixed to the stretcher frame Only two actions are required to take the device into vertical position and choose the correct height At the top of the I V pole there are two robust hooks made of nylon where to hang the intravenous bottles or bags max 2 pcs with maximum load of 1 kg A system made of a strap with Velcro closure allows to fix the intravenous bottles or bags to the I V pole avoiding roll movement 3 2 Main components Track 4 Ella n Description of component Materials Track 4 30 Track 4 E Track 4 Rail Track 4 28 Regulation selectors Oo o e e e Oo o e e e o o e Strap for I V bottle support eer a ae Oo o e e e ee 5 E Ws Gre i el Ve Fig A 3 3 Models This model could be modified with reference to codes and or descriptions without any previous notification IFO1044B Track 4 telescopic I V pole for Ella Self self loading stretcher IFO1047C Track 4 30 telescopic I V pole IFO1048C Track 4 E telescopic I V pole IFO1064C Track 4 for Rail Sherp
7. User s Manual TRACK 4 Telescopic I V pole 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 T V S D Product Service GmbH INDEX General information page 2 Operating instructions page 5 Warnings page 2 Maintenance and cleaning page 7 Description of product page 4 Accessories and pare parts page 8 First edition 05 03 12 Rev 2 14 01 14 Spencer Italia S r l Strada Cavi 7 43044 Collecchio PR ITALY Tel 39 0521 541111 Fax 39 0521 541222 E mail info spencer it k 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 a General or specific warning Ba See instr
8. a IFOLO46C Track 4 28 for emergency stretcher 3 4 Technical data Track 4 Ella Characteristics Track 4 30 Track 4 E Track 4 Rail Track 4 28 Width open mm Width closed mm Minimum height mm Load capacity kg ee eee eee ee eee eee ee ee 1 1 1 1 1 3 5 Reference standards Reference Title of document Modifications to 90 385 CEE Directive about active implants Directive MDD 2007 47 CEE 93 42 CEE about medical devices and Directive 98 8 CE about the introduction of biocides onto the market Legislative Decree 24 02 1997 n 46 Application of the 93 42 CEE Directive about Medical Devices Legislative Decree 25 01 2010 n 35 Modifications and additions to the 20 02 97 Decree n 46 UNI EN ISO 14971 Application of risks managing to medical devices Medical devices Symbols to be used in the medical device labels labeling and information to be provided Part 1 General requirements UNI CEI EN ISO 15223 1 UNI CEI EN 1041 Information supplied by the medical devices manufacturer CEI EN 62366 Medical Devices Application of the utilisation characteristics of engineering to medical devices MEDDEV 2 4 1a b Guideline for the classification of medical devices NB MED 2 5 1 Rec 5 Technical Documentation MEDDEV 2 7 1 Clinical Data UNI EN 14155 Clinical evaluation of the medical devices for human beings Part 2 Clinical evaluation plans 3 6 Environmental conditions Functioning temperature from 15 to 50 C Storage temperature
9. bility for your non compliance with the present Regulatory provisions Specific warnings Establish a maintenance program and periodic testing identifying a reference employee The person to whom the ordinary maintenance of the device is entrusted must ensure the basic requirements foreseen by the Manufacturer in the user s manual 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 e Always respect the maximum capacity of the device as indicated in this user s manual e The device and all its components after washing should be allowed to dry completely before storing e Protect the device from strong bumps or vibrations e Avoid contact with sharp objects e
10. d 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 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 As a Distributor or End Users of products manufactured and or marketed by Spencer Italia S
11. dy for use otherwise you must immediately remove the device from service and contact the Manufacturer 4 3 Functioning 4 3 1 Assembly The installation of Track 4 must be made as follows 1 Insert the plastic pin n 6 into the hole on the two plastic clamps n 1 and couple them to the bearing tube of the device as in fig B 2 Insert the aluminium tube n 2 into the cavity which is obtained by the union of plastic parts as in fig C Secure the body obtained with the socket head screws n 7 provided 4 Tighten the TBEI screws n 8 totally which according to the model of the device will go to press against the walls of the supporting tube or will fit into the holes on the existing profile fixing in each case the Track 4 I V pole 5 For the emergency stretcher s version IFO1046C tighten the fastener n 6 fig A to solidarise to the emergency stretcher in the vertical position Note In the model IF01044 the screw n 8 is not present m Fig B ia 4 3 2 Opening the device 6 Move tothe right the aluminium tube n 2 7 Lift it until it is horizontal 8 Slightly unscrew the nuts n 3 to make possible to remove the inner tube 9 Place the nuts to the desired height and then tighten f o a A o Fig D Fig E 4 3 3 Fixation of intravenous bottles and bags 1 Remove the support hooks n 5 from their place 2 Rotate them 90 the first on one hand the second the other hand 3
12. f 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 f 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 H 2 2 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
13. ity 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 The device does not require periodic review of the planned interventions by the Manufacturer or an authorized centre but is prescribed to clean it and check it as described on the paragraphs Cleaning and 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 3 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
14. ported 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
15. rator 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 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 Correct fixation of all nuts bolts and screws State of use Integrity of components No tube or metal sheet present bends or cracks The inspection frequency is determined by factors such as legal requirements the type of use frequency of use environmental conditions during use and storage Please note that you must do the cleaning as described in paragraph 5 1 and verify functionality before and after each use Spencer Italia S r l declines any responsibility for the proper functioning or damages caused to the patient or user by the use of devices not subject to routine maintenance warranty and will void the compliance to the Medical Device Directive 93 42 CEE The person responsible for routine maintenance must identify damaged worn parts but the replacement or restoration of them can only be carried out by the manufacturer or or by an authorized service centre For other replacement repair activities contact the Manufacturer or an authorized centre 4 Use only accessories original spare parts approved by Spencer Italia S r l otherwise we will accept no responsibil
16. th 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 ofhigh pressure water should 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 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 Possession of the checklist of operations carried out on the appliance 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 ope
17. uctions for use Lot number Product code C 3 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 service spencer it or write to Spencer Italia S r l Strada Cavi 7 43044 Collecchio Parma ITALY In order to facilitate the assistance service please always indicate the lot number LOT shown on the label applied on the box or on the device 1 5 Demolition When the devices are no more suitable for being used if they haven t been contaminated by any particular agents they can be disposed of as normal solid waste otherwise follow the current regulations about demolition 1 6 Labelling Each device has got an identifying label positioned on the device itself and or on the box This label includes information about the Manufacturer the product 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 operators to use the Spencer device has to be kept for a period o
Download Pdf Manuals
Related Search