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User`s Manual - Spencer Italia S.r.l.
Contents
1. All rights reserved No part of this document can be photocopied reproduced or translated into another language without the written approval of Spencer ltalia S r l
2. the appliance itself Those who modify or have modified prepare or have prepared medical appliances in such a way that they no longer serve the pur pose 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 the hazards that can arise as the result of contact with blood or body fluids Handle with care 2 2 SPECIFIC WARNINGS The device can be used on by operators who have received adequate training and after having carefully read this manual Make sure that the IV holder is not bumped or banged Protect the device from dirt and humidity 2 3 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 3 DESCRIPTION OF PRODUCT 3 1 INTENDED USE The built in IV holders described in this manual are ideal for use inside ambulances and rescue vehicles Their function is to support and protect the containers of medical liquids used for the intra venal infusion of medicines These devices offer a considerable reduction of oscillation which could dama ge the liquid containers The Spencer built in IV holders are manufactured in die cast aluminium TRACK 9 or in nylon TRACK 6 TRACK 6 TWIN and can be assembled onto the ceiling of the ambulance They are adapt for use with traditional glass bottles tho
3. CK 6 and TRACK 6 TWIN unblock by pushing towards the centre and then fold upwards as shown in the picture gt m It is essential that the following check routine is carefully carried out before and after each use of the device This routine will include the following aspects Functioning Device condition Device completeness ATTENTION D ONLY MODEL TRACK 6 code IF01050B AND TRACK 6 TWIN code IF01060B ARE CERTIFIED IN CONFORMITY WITH THE EN 1789 NORMATIVE THE PRODUCT CANNOT BE CONSIDERED AS CONFORM TO THIS NORMATIVE IF USED WITH GLASS BOTTLES 4 4 TROUBLESHOOTING ed nO 8 CAUSE REMEDY E Incorrect assembly Make sure that the various components have been Device is unattached from the support correctly assembled and if necessary re assemble The fixing system for the bottle sack does The device has not been assembled correctly Remove from use and contact the manufacturer not move sufficiently Factory defect Materials in use not adapt Remove from use and contact the manufacturer The steel nylon hook is broken and or the Factory defect wraps for the bottle sack are worn Vibrations bumps drops Remove from use and contact the manufacturer Device structure is not intact 5 MAINTENANCE AND CLEANING 5 1 CLEANING The device must be cleaned after each use It is especially important that the hook and the wraps are disinfected so as to avoid contamination caused by secretions blood and any other liqui
4. QUESTS For any information regarding the use maintenance and installation 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 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 2 WARNINGS Ss 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 S r l for any necessary clarifications Regularly check the appliance 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 interference 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 injuries caused by
5. Track 6 Track 6 Twin Track 9 Built in IV bottle holders TRACK 6 TRACK 6 TWIN S Ng Da TRACK 9 This appliance conforms with the Guarantee of Quality system for the production and Directive 93 42 CEE Medical Devices the final control of the products certified by the notifying body TUV SUD Product Service GMBH INDEX General Information page 2 Operating Instructions page 3 Warnings page 2 Maintenance and Cleaning page 4 Description of Product page 2 Accessories and Spare parts page 4 Spencer ltalia S r l Str Cavi 7 43044 Collecchio PR ITALY tel 39 0521 541111 fax 39 0521 541222 e mail info spencer it First edition 18 06 09 Rev 1 02 05 13 www spencer it Thank you for choosing a Spencer product a 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 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 a MEANING AN See instructions for use 1 4 SERVICING RE
6. d which could have contaminated the device during rescue operations The products used to clean the device must be adapt for use on the material the device is made of so as to avoid any possibility of damage which could cause low performance and or consequent poor functioning 5 2 MAINTENANCE 5 2 1 Precautionary Maintenance A routine maintenance programme is not necessary Please remember that the condition of the device must be checked before each use 5 2 2 Special servicing Only the manufacturer or centres with written authorisation are authorised to complete any special servicing operations The device if used as indicated in the following instruction manual has an average life span of 5 years 6 ACCESSORIES AND SPARE PARTS There are no accessories or replacement parts for these items 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
7. damaged parts are the responsibility of the client The appliance must be stored in a dry place free from humidity 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 t 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 Assembly of the built in IV holder into the recess of the emergency vehicle should be carried out by the car builder Normally it is fixed into the cei ling where a cavity has been prepared Once the cavity for the device has been prepared the structure must be screwed in For TRACK 6 and TRACK 6 TWIN using 4 TPSEI M6 screws Class 10 9 For TRACK 9 using 4 TPSEI M5 screws Class 10 9 The screws should be inserted in each of the four holes present on the structure of the device To assemble the device on fragile supports ex fibreglass ABS etc we advice the use of a matrix not supplied For the models TRACK 6 and TRACK 6 TWIN once fixed in position apply the labels in the correct position which will also cover the fixing screws For models TRACK 6 TRACK 6 TWIN and TRACK 9 in order to put the device in the correct functioning mode just lower the moving parts until they automatically block themselves When TRACK 9 is not in use just fold the moving parts back up For TRA
8. ugh no longer compliant with the EN 1789 or with the bags 3 2 MAIN COMPONENTS TRACK 6 e TRACK 6 TWIN IV holders have main structure in nylon nylon hook TRACK 6 or nylon and steel TRACK 6 TWIN wraps to hold the bag with Velcro closure only TRACK 6 TWIN TRACK 9 IV holder has main structure in die cast aluminium steel hook wraps to hold the bag with Velcro closure 3 3 MODELS TRACK 6 Built in IV bottle holder IFO1050B TRACK 6 TWIN Built in double IV bottle holder IF01060B TRACK 9 Built in IV bottle holder in aluminium IFO1054B 3 4 TECHNICAL DATA Maximum external dimensions mm _ Internal dimensions of cavity mm Material TRACK 6 _ 280 x 150 x h35 _ 240 x 110 x h20 nylon z TRACK 6 TWIN 280 x 150 x h35 240 x 110 x h20 nylon TRACK 9 255 x 125 x h30 230 x 100 x h25 aluminium 3 5 ENVIRONMENTAL CONDITIONS Store the device in the correct and suitable conditions and as indicated below Functioning and storage temperature from 10 to 50 C Relative humidity from 15 to 85 4 OPERATING INSTRUCTIONS eee 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 Damage to the appliance caused during transport and handling is not covered by the guarantee Repairs or replacement of the
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