User's Manual - Spencer Italia S.r.l.
Contents
1. 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 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 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 eee 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 In2. 2 has to be positioned as described in paragraph 4 2 1 Fixing QMX 02 to stretcher patient board 4 2 1 Fixing QMX 02 to stretcher patient board 1 Fix the adjustment now to the right or the left side of the Spencer DNA patient board 2 Insert the tapered screw n 3 fig A in the corresponding hole on the DNA patient board and position it with the flange of the micro adjuster n 2 fig A which will have the bushing n 4 fig A positioned inside it 3 Fix the parts together using the nut n 5 fig A and tighten the parts together until the knob is firmly attached to the patient board ATTENTION Do not over force the screw so as to avoid damage to the device A n 4 and hex key and n 10 Allen wrench are required for assembly 4 Once the adjustment device has been fixed fix the Velcro Supplied in the ideal position required Once the Velcro strips are firmly fixed to the patient board fix the cushion 4 3 FUNCTIONING ZEN Optimum stability even when Maintains the head correctly Minimises slipping and con in hyperextension aligned sequent friction with the cushion QMX 01 QMX 02 Allows correct positioning of the head Minimum thickness position Maximum thickness position 4 4 TROUBLESHOOTING PROBLEM CAUSE REMEDY The cushion is not correctly positioned Check that the patient s head is correctly posi Excessive head movement l tioned Wear and tear Remove the device immediately from service an
3. ZEN QMX 01 QMX 02 Cushions for stretcher ZEN QMX 01 QMX 02 Directive 93 42 CEE Medical Devices the final control of the products certified by the This appliance conforms with the Guarantee of Quality system for the production and 3 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 Strada Cavi 7 43044 Collecchio Parma ITALY tel 0039 0521 541111 fax 0039 0521 541222 e mail info spencer it Prima emissione 21 01 1 Rev 1 28 06 13 www spencer it Thank you for choosing a Spencer product 1 GENERAL INFORMATION 1 1 AIM AND CONTENTS The aim of this manual is to give the client all necessary information to attain adequate use of the appliance in the most autonomous and secu re 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 packaging and above all away from any substances or liquids which could compromise perfect legibility 1 3 SYMBOLS USED SYMBOL ee MEANING General or specific warning a See instructions for use i Lot number Oo Product code m A The product
4. d Device damaged Incorrect use contact the authorised service centre 5 MAINTENANCE AND CLEANING eee 5 1 CLEANING Failure to carry out the correct cleaning procedure could increase the risk of cross infections Avoid the use of any harsh chemical and or sol vent Wash using only mild detergents or soap and water The use of high pressure water could damage the device After washing a soft cloth should always be used to dry the device While drying the device make sure that no residuals are left and that all detergents which could cause material decay have been correctly removed This will help increase the life of the product 5 2 MAINTENANCE 5 2 1 Precautionary Maintenance The device does not require programmed servicing 5 2 2 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 regar ding 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 t
5. he manufacturer 6 ACCESSORIES AND SPARE PARTS eee 6 1 ACCESSORIES DR60550K Cushion cover for Zen packet 50 pcs 6 2 SPARE PARTS No spare parts are available for these products 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 ltalia S r l
6. ro strip for fixing to patient board 3 3 MODELS QM50000A Zen Ergonomic cushion QM50001A QMX 01 Welded cushion QM50002A QMX 02 Automatic cushion 3 4 TECHNICAL DATA ZEN QMX 01 QMX 02 Dimensions mm I 260 x 200 410 x 450 320 x 350 Weight g 370 420 950 Thickness mm maximum 200 45 minimum 35 maximum 75 Material closed cell elastic compound PVC PVC Spentex 3 5 ENVIRONMENTAL CONDITIONS Functioning temperature from 0 to 40 C Storage temperature from 0 to 40 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 damage 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 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 The appliance must be checked before every use so as to reveal any working abnor malities and or damage caused by transport and or storage ZEN and QMX 01 do not require fixing The device QMX 0
7. such cases all responsibility will be denied for any malfunctions or injuries caused by 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 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 product must be used by trained personnel only 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 When the device is being used the assistance of qualified staff must be guaranteed 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 Spencer stretcher cushions ZEN QMX 01 and QMX 02 are used to give nuchal support and keep the correct head alignment while offering addi tional comfort and safely to the patient 3 2 MAIN COMPONENTS Zen Cushion in closed cell elastic compound QMX 01 Heat sealed PVC cushion QMX 02 Adjustable cushion with Spentex cover Knob for micro adjustment Velc
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