User's Manual Oxymask Masks for oxygen therapy
Contents
1. 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 l2. carefully evaluated by the operator taking into consideration the patient s condition and the expected duration of the therapy The presence of phthalates DEHP may have kind of events related to the toxicity of this substance The device however has successfully passed the test of in vitro cytotoxicity irritation and sensitization of the skin to which it was subjected in an accredited laboratory 3 PRODUCT DESCRIPTION 3 1 Intended use Oxymask are an optimal solution for oxygen therapy applications The masks are available in various models according to the the concentration of oxygen the patient should be treated with Intervention of the patient on the device is not to be expected 3 2 Main components 1 Adjustable strap 2 Flexible metal clip for nose fixation 3 Mask body 4 Oxygen tube inlet 5 Oy anti crushing tube where present 6 Venturi connections 7 Corrugated tube only 7 Venturi masks ai K Fig A In high concentration models the reservoir bag is present not shown 3 3 Models These basic models could be modified with reference to codes and or descriptions without any previous notification OX20133A OXYMASK 50 Medium concentration mask paediatric 10 pcs OX20139A OXYMASK 50 Medium concentration mask adult 10 pcs OX20136A OXYMASK 100 Variable concentration mask paediatric 10 pcs OX20132A OXYMASK 100 Variable concentration mask adult 10 pcs OX20137A OXYMASK 150 High concentration mask pae
3. 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 lf the instructions belong to another device and not to the device received inform the manufacturer immediately and avoid use of the device e Incase of any doubts about 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 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 of the user are detected the device must be immediatel
4. HP DEHP LATEX FREE Latex free Q Single use device 1 4 Servicing request For any information regarding the correct interpretation of the instruction manual the use maintenance installation and restore of the product please contact the Spencer Customer Care Service 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 the CE mark and the lot number LOT It must never be removed or covered 2 WARNINGS t 2 1 General warnings 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
5. User s Manual Oxymask Masks for oxygen therapy 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 6 Product description page 4 Accessories and spare parts page 6 First edition 22 05 06 Rev 2 20 08 14 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 and maintenance manual The instruction and maintenance manual must be kept together with the product for the whole life of the device inside a dedicated container and above all away from any substances or liquids which could compromise perfect legibility 1 3 Symbols used Symbol Meaning AN General or specific warnings BA See instructions for use LOT Lot number Product code C on The product is compliant with the specifications of the Directive 93 42 CEE Contains phthalates DE
6. cal evaluation plans UNI EN ISO 10993 1 Biological Evaluation of Medical Devices Part 1 Evaluation and Testing 3 6 Environmental conditions Functioning temperature from 10 to 40 C Storage temperature from 15 to 60 C Store the masks in a closed environment in conditions which ensure integrity and protection from dust and atmospheric agents Do not store them under other objects and or materials that might compromise their integrity 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 and cool area free from humidity 4 2 Preparation When receiving the mask it should be checked visually and before every use to ensure the integrity and clearing of the device 4 3 Functioning 1 Make sure the oxygen tube is fixed correctly to the oxygen source Fix one side of the oxygen tube to the inlet of the mask Regulate the oxygen delivery as prescribed by the medical personnel Apply the mask on the face of the patient covering both nose and mouth Pass the elastic s
7. diatric 10 pcs OX20134A OXYMASK 150 High concentration mask adult 10 pcs 3 4 Technical data Model Length of corrugated tube cm Length of anti crushing tube m Oxymask 50 Yes Oxymask 100 Yes Oxymask 150 Yes Component Mask body Oxygen tube inlet Venturi connections Oooo e Anti crushing tube and corrugated tube PVC Reservoir bag where present PVC 3 5 Reference standards Title of document MDD 93 42 CEE European Directive about Medical Devices MDD 2007 47 CEE 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 UNI CEI EN ISO 15223 1 Medical devices Symbols for use in the medical device labels labelling and information to be provided Part 1 general requirements UNI CEI EN 1041 Information supplied by the medical devices manufacturer CEI EN 62366 Magia Devices Application of the utilisation characteristics of engineering to medical Guideline for the classification of medical devices Technical Documentation Clinical Data Medical Devices vigilance system Clinical evaluation of the medical devices for human beings Part 2 Clini
8. nd the users o any medical device As a distributor or end user 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 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 s 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 The distributor or final user is aware that in the event of any failure to conform to the above men
9. ntegrity and presence of any damages to the device due to possible unsuitable storage conditions e Expiration date or average life span if any In order to prevent possible damage to the packaging that may affect the state of cleanliness and integrity of the device it is necessary to ensure compliance with the conditions set out in paragraph 4 1 The device when stored as described in the following instructions needs to be retired to the overcoming of the 5th year of life or at least manifestation of loss of integrity of materials Spencer Italy S r l declines any responsibility for the incorrect operation or damage caused by reuse of single use devices or arising from their employment over the period of their expected life span 6 ACCESSORIES AND SPARE PARTS There are no accessories or replacement parts 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 Soencer 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
10. ssistance of at least one operator when using the medical device 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 With reference to the D Lgs 24th 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 a
11. tioned requirements you will be deemed fully responsible for all damages that might occur Therefore Spencer Italia S r l expressly disclaims any responsibility and or liability for your non compliance with the present regulatory provisions Specific warnings The masks for oxygen therapy may be used only by operators trained in their use The operator must be able to explain to the patient the oxygen therapy procedures help the patient to assume the most appropriate position for the therapy connect any additional devices to the mask use properly and safely all devices and oxygen distribution systems check the proper functioning of all equipment know how to interpret all the physiological responses of the patient know how to evaluate the effectiveness of therapy The mask should not be exposed or come into contact with thermal ignition sources and flammable agents The administration of oxygen in the presence of hydrocarbons generates explosive mixtures Do not use the mask in polluted environment Check the condition of the product when opening its box and before each use k k e These devices are disposable e Oxymask contain phthalates DEHP type 2 3 Contraindications and side effects The use of this device if applied by operators trained to oxygen therapy techniques does not present any contraindications or collateral effects directly connected with the use of Oxymask The practice of oxygen therapy has side effects that must be
12. trap behind the head and the ears of the patient Regulate the tension of the elastic strap pulling both ends of the strap through the dedicated parts of the mask Adapt the flexible metal part of the mask to the shape of the patient s nose ee E E a For Venturi masks the suggested parameters are the following 1 4 4 Troubleshooting PROBLEM CAUSE REMEDY Immediately place the device out of service and Lesion of one or more components replace it with a similar one Report the problem to the manufacturer Device not properly stored placed under Immediately place the device out of service and Detachment of the tube from the mask p pery p y P a heavy materials or high temperature replace it with a similar one The mask shows structural functional damage Device not properly stored or has been Immediately place the device out of service and Break of the elastic strap i i cate _ exercised excessive tension on the elastic replace it with a similar one Immediately place the device out of service and Metal clip missing The clip is accidentally detached replace it with a similar one The device must be kept with the original packaging 5 MAINTENANCE AND CLEANING Oxymask are disposable devices therefore they do not require programmed operations of maintenance and cleaning Checks to be carried out before each use are as follows e Cleanliness of the device e Absence of cuts holes tears on the structure e State of i
13. y removed from service and 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 Never leave the patient without the a
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