User's Manual WARMPAK HEATING BAG
Contents
1. User s Manual WARMPAK HEATING BAG 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 SUD Product Service GmbH INDEX General information page 6 Operating instructions page 7 Warnings page 6 Maintenance and cleaning page 8 Description of product page 7 Accessories and spare parts page 8 First edition 31 03 11 Rev 0 31 03 11 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 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 AN a General or specific warning a See instructions for use Lot number Product code C The product is compliant with the specifications of the Directive 93 42 CEE 1 42. 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 6 ACCESSORIES AND SPARE PARTS There aren t any accessories or spare parts for this item 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 8
3. 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 Follow the current regulations 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 of 10 years after the disposal of the device itself This
4. 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 _ al 2 2 2 3 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 Never leave an unassisted patient The presence of at least one operator is essential at all times when the medical device is in use Do no
5. in question 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 requested e 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 indicated on paragraph 4 2 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 device does not require periodic review of the planned interventions by the Manufacturer or an authorized centre 5 3 Special servicing and average life span The device when damaged can not be repaired but must be put out of service The device if used as indicated in the following instruction manual has an average life span of 3 years Spencer Italia
6. register will be made available to the Competent Authorities and or Manufacturer if requested e Spencer Italia S r l is always available for conducting training courses 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 personnel to help when using the device as they may cause injury to the patient or themselves e Perform the required maintenance and to respect the life span of the device as indicated by the Manufacturer in the 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 device 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
7. may cause the risk of cross infections e Absence of cuts holes tears on the structure 5 MAINTENANCE AND CLEANING 5 1 Cleaning Failure to carry out cleaning operations may involve the risk of cross infection due to the presence of secretions and or residuals The operator must always wear adequate personal protection such as gloves and mask etc during all checking and cleaning procedures The heating bag should not be immersed in water Wash exposed parts with warm water and mild soap never use solvents or stain removers In case of any disinfecting procedures do not use solvents wih corrosive action on the materials constituting the device Rinse thoroughly with warm water making sure that you have removed all traces of detergent which may deteriorate 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 and periodic 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
8. of nylon Internal lining in Alutex Padding in Thinsulate Velcro closure Dimensions 252 x 6 x h370 mm Weight 200 g 3 3 Fun Sto Environmental conditions ctioning temperature from 10 to 50 C rage temperature from 0 to 40 C Relative humidity from 20 to 40 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 sub 4 2 On 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 stances or chemical agents which could cause damage and reduce safety characteristics Functioning receipt of the product remove the packaging and display the material so that all components are visible and check that all components pieces on the accompanying list are present 7 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 e Cleanliness of the device remember that the failure of cleaning
9. t 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 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 o any medical device Specific warnings Establish a main
10. tenance program and periodic testing identifying an 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 Never leave the patient on the device without supervision he may be injured The device and all its components after washing should be allowed to dry completely before storing Do not wash the device with a washing machine Do not use a drying machine Avoid contact with sharp objects Do not use the device if it is punctured torn frayed or excessively worn 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 loss of heat in trauma patients can be reduced thanks to the use of the heating bag Warmpak during the infusions It can be used with infusion bags of 500 and 1000 cc At the front there is a window for the monitoring of the amount of solution remaining Inside a mesh bag allows for the positioning of an instant heat bag It can also be used with the IV sub ministration bag Air WIV or WIV thus obtaining an efficient control of both the temperature and the pressure of the infusion The internal lining of Thinsulate guarantees a good thermal insulation from the external environment 3 2 Techinical data Materials External cover in tear pro
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