User Guide Antidecubitus systems EURO BASIC

User Guide Antidecubitus systems EURO BASIC User Guide Euro Basic Rev 06 del 11/2011 pag. 1 di 16

INDEX Par. Title Page 1 Instructions 3 2 Standards and directives 3 3 Identifying the device 3 4 Description and components 4 5 Intended use 5 6 Improper and incorrect use 5 7 Warnings 6 8 Control panel 7 9 Installation 7 10 Starting the compressor 8 11 Dynamic and static functioning 8 12 Nursing 8 13 Inflation regulation 8 14 Alarms 9 15 CPR function 9 16 Cleaning the system 10 17 Fuse replacement 11 18 Handling and storage 11 19 Trouble shooting 12 20 Technical characteristics 21 Waste of disposal 22 Warranty 12 13 14 User Guide Euro Basic Rev 06 del 11/2011 pag. 2 di 16

Thank you for choosing us! Thank you for choosing our product. We would like to remind you that EuroAusili is in the forefront in the production of aids that prevent decubitus ulcers at different stages. Please read and preserve this booklet carefully. It provides important information on how to use the product and its maintenance. 1. INSTRUCTIONS This document belongs to EuroAusili and it is forbidden to make partial or full copies of it in any way (mechanical or electronic) without permission from the manufacturer. EuroAusili is free to make any useful technical and commercial changes that are believed to be necessary at any time and without notice. Therefore all the data and information reported could be changed or updated. This booklet is given with the product. It is part of it and it is up to the customer to preserve it properly. 2. STANDARDS AND DIRECTIVES Euro Basic anti decubitus systems, produced by EuroAusili, are designed and built according to Medical Devices Directory 93/42/CEE and its revised version. The systems comply to Electrical Safety of Electro Medical Systems Standard CEI EN 60601-1 and to Electromagnetic Compatibility of Electro Medical Systems Standard CEI EN 60601-1-2. The systems are re-usable. 3. IDENTIFYING THE DEVICE Each system can be identified thanks to three labels: the compressor, the base of the mattress base and the cover, show the model, and the serial number in order to grant each system to be tracked. EuroAusili will not recognise any product if it does not have the identifying label or if the data on it is illegible. The product will thus cease to be under warranty. User Guide Euro Basic Rev 06 del 11/2011 pag. 3 di 16

Label Position Symbol Meaning Manuifacturer Back of the compressor Caution! Please consult user manual Production date (month and year) Type B applied part Class II device Do not dispose of as normal waste Characteristics of the fuse Year of production Base of the mattress and bottom of the cover S.N. Serial Number Manuifacturer 4. DESCRIPTION AND COMPONENTS Euro Basic anti-decubitus system is classified as Class I medical devices according to Medical Devices Directory 93/42/CEE and its revised version. User Guide Euro Basic Rev 06 del 11/2011 pag. 4 di 16

Eur Basic system is to be used in prevention and therapy of ulcers caused by decubitus and is suitable for body weight from 40 and max. 150 Kg. Euro Basic system includes: - A three way compressor with pressure regulator - Overlay mattress including: 18 inflatable and individually interchangeable elements made of nylon-polyurethane 1 lower case, with straps and snap release buckles in order to fasten it to the bed 1 PES/PU cover 3 tubes which connect the mattress to the compressor The mattress-version (Euro Basic Pro) is obtained by adding a removable PU foam base (4,5 cm). 5. INTENDED USE The system is intended to be used in nursing environments or in private homes to reduce the risk of contracting decubitus ulcers in patients at risk or who already have wounds. The mattress has to be installed according to instructions given in the specific chapter. In order to use the product properly, we suggest you turn to medical or paramedical staff. 6. IMPROPER AND INCORRECT USE Improper and incorrect use description Consequences / remarks Using the system in order to prevent decubitus ulcers on patients who run a higher risk than the one for which the system is meant for. Using the system in order to cure decubitus ulcers on patients who run a higher risk than the one for which the system is meant for. Using the systems with patients that weigh less than 40kg Using the system with patients that weigh more than maximum system capacity Using the system on patients who have ulcers at a more advanced stage than the one for which the system is meant for. Using the system on patients with illnesses or traumas which are incompatible with alternate functioning Risk: development of decubitus ulcers No recovery of present ulcers. Risk of deterioration of present ulcers and development of new ones Ineffectiveness of the system. No guarantee that ulcers will be prevented or cured Risk of mattress breakage and of development of decubitus ulcers No recovery of present ulcers and risk of deterioration of present ulcers and development of new ones Risk: worsening of the patient s general health conditions and of the specific illnesses and traumas. User Guide Euro Basic Rev 06 del 11/2011 pag. 5 di 16

Using or storing the system in the presence of flames or other elements which may catch fire Using the system on beds without bars or with bars that are too low Risk: damaging the system and its functionality The patient runs the risk of falling from the bed Using spare parts that are not original Modifying or tampering with the system without manufacturer s permission Risk: damaging the system and its functionality Non-observance of instructions in the manual 7. WARNINGS Keep system away from flames, heaters and protect from humidity Avoid any contact with flammable gasses and liquids. RISK OF EXPLOSION Before managing the compressor make sure that it is not power supplied Keep and use compressor in dry places Do not use the system in the presence of high electromagnetic fields. Electromagnetic interference can cause damage to the equipment and its malfunctioning. Use device only for the purposes for which it has been designed. Improper use can cause damage to people and things and the warranty will cease to be active. All repairing and maintenance have to be done by qualified staff. Otherwise the warranty will cease to be active. User Guide Euro Basic Rev 06 del 11/2011 pag. 6 di 16

8. CONTROL PANEL Leds and buttons: ON/OFF: switch on/ off STATIC/DYNAMIC When switched to STATIC means that static mode has been set When switched to DYNAMIC means that dynamic mode has been set ALARM: system is malfunctioning Comfort: shows the pressure range that has been manually set 9. INSTALLATION - Lay overlay - mattress onto the traditional mattress; air hoses must be at foot side. - Make sure that bed safety sides are high enough for the mattress so as to guarantee patient s safety conditions - Make sure that CPR valve near the head end is shut by pulling the bigger red block firmly without pushing the transparent flap and making sure not to extract the block - Pull out the handle at the back of the compressor and hang the compressor at the foot end of the bed or place it underneath the bed. Make sure that it has been clasped properly or that it is in a stable position. - Do not cover the compressor in order to avoid overheating. - Place the connectors of the three tubes in the sockets at the bottom of the compressor without obstructing them. The order with which tubes are placed is not important. Make sure that tubes are not kinked. - Plug the power cord into an electrical outlet at 220-230 V AC, 50 Hz User Guide Euro Basic Rev 06 del 11/2011 pag. 7 di 16

10. STARTING THE COMPRESSOR - Turn on the compressor by pressing I/O. Make sure that the ON button is lightened. If it is not, look at the procedure described in the trouble-shooting section. - Until the overlay-mattress reaches minimum pre-established pressure, the ALARM led will stay on. Normally, this phase lasts 20-30 minutes. - Switch to ON the STATIC button. - Turn the regulating pressure button at max, in order to obtain a faster inflation. - When the ALARM led switches off, it is possible to set the function (whether dynamic or static) and inflation regulation that at best suite patient s needs. 11. DYNAMIC AND STATIC MODE In dynamic mode, the compressor inflates two of three consecutive elements alternatively, apart from the three head elements which always remain static. The dynamic cycle is programmed to deflate one of three sections every three minutes, plus 1 minute when all three sections are at the same pressure. The cycle thus lasts 10 minutes. In static mode all elements have the same level of inflation and the same pressure. To switch from dynamic to static, turn ON the STATIC button 12. NURSING For nursing procedure or any situation requiring a hard mattress, we suggest to set the function on STATIC and turn the pressure regulation button to the maximum level. We advise not to use the system with the pressure regulated as above. When nursing procedures are terminated, switch to the dynamic function and set the pressure as per patient s needs. 13. INFLATION ADJUSTMENT In order to choose the best level of inflation, we suggest to use the following hand check procedure (approved by AHCPR - Agency for Health Care Policy and Research): User Guide Euro Basic Rev 06 del 11/2011 pag. 8 di 16

- open the side zip which fastens cover and inferior case - slide your hand in between inflatable elements underneath the patient s buttock. - Make sure that there are at least 2.5-4cm between patient s buttock and underlying base. - In case the above mentioned distance: - Increase if distance is less than 2.5 cm - Decrease if distance is more than 4 cm 14. ALARMS Inflation pressure of the mattress is constantly monitored by an internal pressure switch. If alarm activates (EXCLUSION MADE FOR INITIAL INFLATION) we recommend to follow this procedure in order to identify the cause: - check that tubes coming out of the compressor have been plugged in correctly - check that the inflatable elements of the mattress and the lateral distribution band are not broken. - Check that connection hoses are not kinked, twisted or entangled to the bed - check that inflatable elements are clicked into the clutches of the lateral distribution band If the alarm continues, please contact customer service without opening the compressor. Do not perform any action on the compressor. Maintenance has to be carried out only by authorised staff. 15. CPR FUNCTION Euro Basic overlay mattress is provided with a fast deflation function (CPR) in order to allow cardiopulmonary resuscitation to be performed on the patient. The CPR valves are located in the left-hand side of the head end of the mattress. In normal conditions, the CPR valve has to remain closed. To close it, click the three valves of the big red block into plugs present on the red band. Pull gently to verify that the block does not come out. If necessary, before performing CPR, open CPR valve to release air quickly from the mattress. To open it, firmly pull out the big red block, pressing on the transparent tongue. User Guide Euro Basic Rev 06 del 11/2011 pag. 9 di 16

PRESS AND PULL 16. CLEANING THE SYSTEM Cleaning the compressor How often: monthly What to do: clean with damp cloth and possibly add a disinfectant such as Sporicidin spray. DO NOT POUR LIQUIDS DIRECTLY ON THE MATTRESS Cleaning inflatable elements How often: after every change of patient or, in case of single patient use, every two months What to do: - clean with damp cloth and, if necessary, add delicate alcohol-free, bleach-free or chlorinefree disinfectant. - Machine wash: max temperature 60 C using delicate alcohol-free, bleach-free or chlorinefree disinfectant; tumble drying: max temperature 60 C - An example of cleaning: - pre-washing: 60 C, for 30 minutes, solution of 1% of Sanitrate or 75 ml of Montana detergent. - washing: 60 C, for 50 minutes, Trig solution at 5% - rinse - drying: at 60 C DO NOT USE DETERGENTS CONTAINING ALCOHOL, CHLORINE OR BLEACH. THEY COULD DAMAGE THE CHEMICAL STRUCTURE OF THE MATTRESS DO NOT USE ABRASIVE MATERIALS SUCH AS IRON BRUSHES, STEELWOOL, KNIFE BLADES OR OTHER SHARP OBJECTS DO NOT IRON Cleaning the cover User Guide Euro Basic Rev 06 del 11/2011 pag. 10 di 16

How often: twice a week and before every new patient. What to do: machine wash and dry. Maximum temperature in both cases 60 C. For daily cleaning we suggest you use a damp cloth and a soft detergent or disinfectant. DO NOT USE DETERGENTS CONTAINING CHLORINE OR BLEACH. DO NOT USE ABRASIVE MATERIALS SUCH AS IRON BRUSHES, STEELWOOL, KNIFE BLADES OR OTHER SHARP OBJECTS DO NOT IRON 17. FUSE REPLACEMENT TO REPLACE FUSE, UNPLUG CABLE TO AVOID ELECTRIC SHOCK Open the fuse holder located below electric socket on the bottom part of the compressor. With the aid of a screwdriver, extract blown fuse and replace it with a new one with the same electrical characteristics. Use only 5 mm, 250V delayed 500 ma fuses. 18. HANDLING AND STORAGE In order to handle and store system correctly, please keep original packaging. Avoid abrupt transportation and blows to the compressor, since its electrical and electromechanical components are very delicate. Keep the compressor in the following conditions: - environment temperature: 0 40 C - relative humidity: < 85% The product is delivered inside a cardboard box. This box is sealed with adhesive tape in perfect hygienic conditions. When you receive the product, make sure that it corresponds to your order and that it has not been damaged during transportation. User Guide Euro Basic Rev 06 del 11/2011 pag. 11 di 16

In case of any problems, keep packaging and contact the currier and EuroAusili within 48 hours. Without any specific agreement, goods will travel at customer s risk. 19. TROUBLE-SHOOTING PROBLEM POWER led does not turn on (the compressor is not working) The mattress does not inflate or only partially inflates ALARM led remains turned on When setting the compressor to the minimum, the alarm activates Patient sinks into the mattress without alarm going off or the mattress is too rigid POSSIBLE SOLUTION Check the cable, the plug and the socket; check compressor fuse. Check tubes, connections, the lateral distribution band; if the problem continues to exist, please contact maintenance service. Check tubes, connections, the lateral distribution band; if the problem continues to exist, please contact maintenance service. This setting is too low for patient s weight. Increase comfort level. Adjust comfort level as explained in the previous paragraph. 20. TECHNICAL CHARACTERISTICS System Euro Basic Type of mattress Overlay mattress Dimensions overlay mattress (inflated) 200 x 85 x 10,5 cm 200 x 85 x 15 cm (with the addiction of PU foam base) Inflatable elements Nylon-PU - depth: 10 cm Circular section Maximum patient weight (Kg) 150 Emergency deflation time (CPR) 10 seconds Inintial inflation time 25 minutes Cover Waterproof PES/PU, transpirant to water steam Compressor shock proof ABS enclosure 30 x 18 x 13,4 cm User Guide Euro Basic Rev 06 del 11/2011 pag. 12 di 16

Technical characteristics Certifications Warranty Supply: 220-230 V AC 50 Hz Power absorbed: 8 W Fuse: 250V, T500mA, 5mm Electric protection: II Applied part: type B Medical device, class I, in conformity with 93/42/EEC Rule 2 years IMPORTANT: this system complies to safety standards CEI EN 60601-1 and CEI EN 60601-1-2 and to 93/42/CEE directive about medical devices. If the user finds that the system does not work properly, it works intermittently and it is near electrosurgical devices, the problem could be caused by electromagnetic interference. In this case move the source of interference away. IMPORTANT: the manufacturer will supply, upon purchaser s request, circuit patterns, list of components and the instructions that qualified staff may need in order to repair the compressor IMPORTANT, for qualified staff: before handling compressor, disconnect the power cord.. All maintenance must be undertaken by qualified staff only. Please contact your dealer in case of need. 21. WASTE DISPOSAL Waste disposal instructions according to directives 2002/95/CE, 2002/96/CE and 2003/108/CE concerning reduced use of dangerous substances in electrical and electronic devices and waste disposal: The crossed-out wheeled bin symbol indicates that the old product has to be disposed of separately from other waste. Correct disposal of such apparatus, will be taken care of by the manufacturer. When you want to dispose of waste material, please contact the dealer and follow the national rules concerning waste disposal. Correct waste disposal and recycling will help prevent potential negative consequences for the environment and human health. Incorrect unauthorised disposal will lead to fines according to local rules. User Guide Euro Basic Rev 06 del 11/2011 pag. 13 di 16

22. WARRANTY CONDITIONS 1. The 24-month warranty, which becomes effective on the date of purchase, covers any manufacturing problem, and it includes both the substitution of faulty spare parts, and maintenance costs, only if these conditions are followed: 2. The warranty is valid only if the product has been used correctly, following the instructions and if the compressor has not been opened and/or tampered with. 3. The manufacturer will decide whether to repair the fault or to substitute the faulty part with a new one. 4. The warranty does not cover: - faults deriving from incorrect installation or use - faults deriving from maintenance done by unauthorised personnel. - Parts that are subject to wear and tear: pump membranes, distributing valve. 5. After a period of about 5000 hours or 12 months that the product has been working, please contact your seller or dealer for maintenance of the compressor Use only original products. Substituting broken or worn out parts with low quality products or home-made products, may jeopardize the correct functioning of the system. This will also make warranty ineffective. User Guide Euro Basic Rev 06 del 11/2011 pag. 14 di 16

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