OPERATOR S MANUAL A DEVICE FOR AEROSOL THERAPY AND RESPIRATORY EXERCISE (IPPB WITH TPEP ) UNIKO-TPEP E 0051 Operator s manual UNIKO-TPEP E MPR118 Rev. 2-09/2010 Pag. 1 /12
Medical Products Research S.r.l. Via R. Cuttica, 43 20025 Legnano (MI) ITALY Tel + 39 0331 597 992 Fax: +39 0331 485 089 e-mail: info@mpr-italy.it - www.mpr-italy.it Index Paragraph 1. WARNING 2. DIRECTIVES AND NORMS 3. DIRECTIONS FOR USE AND CLASSIFICATION 4. ASSEMBLY INSTRUCTIONS 5. DESCRIPTION OF THE DEVICE 6. PRECAUTIONS 7. INSTALLATION AND USE 8. CLEANING AND DISINFECTION 9. REPLACING THE FUSE AND THE FILTER 10. TROUBLESHOOTING 11. OPERATING CONDITIONS 12. TRANSPORT AND STORAGE 13. TECHNICAL SPECIFICATION 14. WASTE DISPOSAL 15. WARRANTY CONDITIONS 16. LIST OF ACCESSORIES AND REPLACEMENT PARTS 1. WARNING This document is the property of Medical Products Research S. r. l. Neither partial nor full reproduction is permitted by whatever means, mechanical or electronic, without the written authorisation of the manufacturer. Medical Products Research reserves the right to modify, at any time and without notification, the technical and/or commercial characteristics which they consider to be useful. Therefore the data and the information given may be changed and/or increased. The purpose of this booklet is intended solely for use with the product; therefore it constitutes an integral part of the product and must be kept in good condition for the care of the user. UNIKO-TPEP E is equipped with two piston compressors with air filters which should be replaced periodically (once per year). Reliable, requiring no lubrication, it is built in compliance to European norms. UNIKO-TPEP E is supplied with the following components which form an integral part of the product: kit for respiratory exercise and aerosol therapy, carrying bag and electrical cable. Keep the cable away from hot surfaces. Never handle the plug with wet hands and do not use the product when taking a bath or shower. Never immerse the product in water. Immediately pull out the plug from the main electrical socket if this happens. Neither remove nor touch the product immersed in the water without first removing the plug from the main electrical socket. Do not re-use the product after immersing in water but send it immediately to your authorised service provider. Always remove the plug from the electrical supply immediately after use. Any repairs must only be undertaken by authorised personnel. Unauthorised repairs will render the warranty null and void. Dispose of the device in compliance with the standards in force. 2. DIRECTIVES AND NORMS UNIKO-TPEP E is designed and constructed in accordance with Directive 93/42/CEE for medical appliances. UNIKO-TPEP E conforms to the following norms: CEI EN 60601-1 2 ed. (Electromedical device safety) CEI EN 60601-1-2 (Electromagnetic compatibility) EN 13544-1 (Nebuliser systems and their components) UNI EN ISO 10993-1 (Biological evaluation of medical devices Part 1 : Evaluation and testing) UNI EN ISO 10993-5 (Biological evaluation of medical devices Part 5 : Tests for in vitro cytotoxicity) UNI EN ISO 10993-10 (Biological evaluation of medical devices Part 10 : Tests for Irritation and delayed-type hypersensitivity) Operator s manual UNIKO-TPEP E MPR118 Rev. 2-09/2010 Pag. 2 /12
3. DIRECTIONS FOR USE AND CLASSIFICATION UNIKO-TPEP E is a device intended for the following use: respiratory exercise(ippb with TPEP ) aerosol therapy The construction of the device is such that it could be used for long periods or continuously but the treatment cycle as presribed by the clinician must be respected, for all patients. UNIKO-TPEP E promotes the removal of secretions in the respiratory tract and thus helps to promote targeted respiratory exercise. It also helps a correct pharmacological prophylaxis and the distribution of medicines through aerosols, for the treatment and care of the respiratory airways, according to the instructions given by the clinician. The device is appropriate for use as follows: patients with respiratory diseases and with the ability to cough, to effect a respiratory exercise; patients requiring nebulised medication. The device can be used in complete autonomy by the patient, provided they have been adequately trained, either in the hospital or at home. The device is supplied non sterile and is reuseable with the patient circuit which is always intended to be single patient use. UNIKO-TPEP E is classified as class IIa and according to directive 93/42/CEE. 8 2 7 3 1. ON/OFF 2. Switch A: activates Aerosol mode 3. Switch B: activates TPEP mode 4. Outlet for TPEP 5. Air pressure sensor outlet 6. Air pump outlet for aerosol therapy 7. Display 8. LED display on 6 1 5 4 Fig. 1 Control panel UNIKO-TPEP E 4. ASSEMBLY INSTRUCTIONS The device consists of a control unit and a kit (code UNIKIT) for different modes of use. The control unit can be re-used and also with different patients, but the use of the patient circuit kit is strictly single patient use, in order to avoid the risk of cross contamination. The kit is supplied non sterile inside a bag with disposable items. To assemble the appropriate kit, follow the instructions and diagrams for the desired therapy as shown: 1) Assemble tubing and filters B a) Attach the tubes in the outlets of the control unit (see Fig 1), one to the air pressure sensor outlet (5) and one to the TPEP outlet (4), using the filters B supplied: Tube Filter B To outlet 5, see Fig. 1 Universal Connector Tube Filter B To outlet 4, see Fig. 1 Operator s manual UNIKO-TPEP E MPR118 Rev. 2-09/2010 Pag. 3 /12 Fig. 2
i) Respiratory exercise (TPEP ) Assemble the respiratory kit as shown below and then attach the tubes to the universal connector and to filters B (see 1a : assemble tubing and filters) which are connected to outlets (4) and (5) as shown in Fig. 1 and in Fig. 2. Universal Connector (5) See Fig. 1 Filter A Closed mouthpiece (4) See Fig. 1 ii) Aerosol therapy Prepare the aerosol chamber: (1) Unscrew the Fasterjet chamber, splitting it into two parts (2) Fill the lower part of the chamber with the medication as presribed by the patient s doctor. Warning: the level notches on tne inside of the chamber are an approximate guide only. (3) Screw the two parts of the chamber together, keeping the chamber upright to avoid spillage. Assemble the aerosol therapy kit as shown, remember to position the valve of the mouthpiece uppermost: FASTERJET chamber Mouthpiece with valve To outlet (6) see Fig. 1 Nebuliser Tube G N A iii) Aerosol therapy with respiratory exercise (TPEP ) Follow the instructions given in points (i) and (ii) Assemble the FASTERJET chamber as described in (ii). Then connect it to the universal connector as shown in the diagram below. Attach the valved mouthpiece to the universal connector, keeping the valved side uppermost. Attach the tubes to the universal connector as shown in (i) and to filters B (see 1a: assemble tubing and filters) which are connected to outlets (4) and (5) as shown in Fig.1. and in Fig. 2. Connect the FASTERJET chamber to the nebuliser tube as shown in the diagram. Connect this tube to outlet (6) as shown in Fig. 1 and in Fig. 2. Universal Connector (4) see Fig. 1 FASTERJET chamber Mouthpiece with valve (5) see Fig. 1 To outlet (6) see Fig. 1 Nebuliser tube iii) Spray therapy Assemble the kit as shown in the diagram: Assemble the tubing and filters as described in 1a) which connects to the outlets as shown in Fig. 2 Operator s manual UNIKO-TPEP E MPR118 Rev. 2-09/2010 Pag. 4 /12
(4) see Fig. 1 Filter A (5)see Fig. 1 Spacer Connector Closed mouthpiece 5. DESCRIPTION OF THE DEVICE - Control unit Each and every unit is identified with a label placed on the bottom of the compressor. - Single patient use kit Each and every kit is indentified with a label on each and every packet. Label on the bottom of the compressor: Explanation of symbols and abbreviations: Manufacturer 0051 CE mark followed by the code of the notifying body Attention, consult the operator s manual Date of manufacture (month and year) Label on the packet which contains the kit: Ref S.N Type B appliance Commercial name of the product Serial number Do not dispose of the appliance as normal refuse Fuse type Class II appliance Part n. LOT Identifying code of the item LOT number (made up of two figrues for the year of manufacture, two for the week of manufacture) 6. PRECAUTIONS UNIKO-TPEP E is a medical device for professional use and must be used solely in accordance with medical prescription. The operation of the unit must be in accordance with the instructions given in this manual. Carefully read the manual in order to use and maintain the device correctly. For any explanations required, contact your dealer. Do not use the device for means other than those indicated. The manufacturer will not accept any responsibility in the case of inappropriate use. Operator s manual UNIKO-TPEP E MPR118 Rev. 2-09/2010 Pag. 5 /12
This device is not designed for anaesthetic or pulmonary ventilation use. Do not use the device in the presence of anaesthetic flammable mixtures with air, oxygen or nitrogen protoxide. The compressor must not be opened! Maintenance must only be undertaken by qualified personnel authorised by the manufacturer. Upon request the manufacturer will provide instructions or other information which assists technical personnel with the repair. Modifications to the product are not permitted. Do not use the device in the presence of increased electro-magnetic fields. Electro-magnetic interference can cause damage to the apparatus and malfunctioning of the device. Only use the device for the purpose for which it was designed. Inappropriate use, in addition to causing injury to people and/or others, will also render the conditions of the guarantee as null and void. The use of the patient circuit is strictly single patient use. Do not dispose of as normal refuse! Follow the instructions in the section of this manual concerning disposal. Only use the device with the original compressor and accessories as indicated in this manual. Use the device and its accessories absolutely according to the instructions given by the clinician. Only use the medication as prescribed by your own doctor, respecting the dose and the method indicated. Keep the device away from hot surfaces. Place the device on a stable surface. Always pull the plug out after use. Do not use extension leads and/or adapters. Completely unwind the electrical cable to avoid overheating. The device in its casing is not protected against penetration of liquids. Absolutely avoid contact with water or other liquids. In the event of penetration of liquids inside the casing, pull the plug out immediately from the electrical socket. Do not re-use the device after it has been penetrated with liquids internally, and return it immediately to your own sales/service representative. The device contains removable items which are very small and can be easily swallowed. The use of the device by minors or the disabled requires the presence of an adult with full mental faculties. Do not leave the device un-supervised in easy reach of young children and the disabled. Store the device in dry and clean conditions, away from the light, heat sources and atmospheric agents. Store the kit in the ambient conditions as specified in this manual. 7. INSTALLATION AND USE Preliminary operation: - Connect the kit which corresponds to the mode of use required, following the instructions given in Para.4. - Connect the electrical cable to the socket at the back of the device - Connect the electrical cable to a socket which is rated at 220-230 V AC, 50 Hz - Switch the device on, first of all by pressing the ON/OFF switch for 1 second only. At the time of switching on, the following menu appears on the display: AEROSOL TPEP Operator s manual UNIKO-TPEP E MPR118 Rev. 2-09/2010 Pag. 6 /12
- It is possible to modify the date, time and language by pressing and holding the ON button (the machine must be in the off position) until the USER MENU appears; on releasing the button it is possible to then make the changes: press button A to activate the SCROLL function to reach the parameter you want to change and press the ON button. The characters which can be changed will flash: to change the date and time press button A to activate the INC VALUE function and press button B to activate NEXT in order to go to the next character you wish to change; to change the language press button B until the chosen language appears. To confirm the changes, press ON. To finish, scroll to EXIT and press the ON button. - Choose the function mode : o Pressing button A (2) activates the aerosol mode. Ensure that the components have been assembled as indicated in paragraph 4, point (ii). A minute counter appears above the word AEROSOL, indicating the duration of the therapy. Pressing button A (2) again interrupts the aerosol therapy. 00:06 AEROSOL TPEP o Pressing button B (3) activates the TPEP mode. Ensure that the components have been assembled as indicated in paragraph 4, point (i). Position the nose clip correctly and breathe making sure that the lips are tightly placed around the mouthpiece, aim to maintain the effort indicator in the central area (the smiling face). To achieve a correct therapy, aim to prolong the expiratory phase as much as possible. As soon as the mode is activated a minute counter appears. It is possible during the respiratory exercise session, by pressing and holding the ON/OFF (1) switch, to display the parameters of the current session. To interrupt the TPEP mode, press button B (3) again, until the word TPEP appears. 00:06 AEROSOL NORMAL o The two modes described above can also be activated at the same time by pressing buttons B and A. In this case both minute counters are activated. 00:04 00:34 AEROSOL NORMAL - In selecting the TPEP mode it is possible to choose TWO different levels of resistance: press button B (3) repeatedly for 5 seconds, the words NORMAL or EASY will be displayed in succession which correspond respectively to the respiratory exercise normal and easy. Press to display the required resistance. - At the end of the session, after pressing the corresponding button again in the active mode, turn the device off by pressing and holding the ON/OFF switch for four seconds. - Disconnect the electrical cable from the mains supply and then from the device. - Disconnect the assembled kit and clean and/or dispose of as appropriate. - When switching the device on again after the previous session, the last TPEP mode (i.e. easy or normal) which was set, will appear on the display. 8. CLEANING AND DISINFECTION Always wash your hands before cleaning and disinfecting the device and accessories. Cleaning the device Operator s manual UNIKO-TPEP E MPR118 Rev. 2-09/2010 Pag. 7 /12
Never wash the device in water or immerse it; only use a damp cloth with non abrasive and non aggressive detergent. Cleaning the reuseable kit Clean all the components ( with the exception of the nebuliser connecting tube, ref MPR 17, which should be replaced with new tubing in all cases) in hot tap water (approx 40 C) for about 5 minutes adding a small amount of detergent (following the instructions of the detergent manufacturer as to the amount to be used and limitations of use). Rinse freely, making sure that all residues of the detergent have been eliminated. Allow all components to dry thoroughly. It is also possible to clean these accessories in a dishwasher. In this case, select a wash cycle which operates at 50 C, place the separated parts of the nebuliser chamber, the mouthpiece and the tubes, except for nebuliser connecting tube, inside the dishwasher and start the programme. Do not wash the accessories in the dishwasher with any other item. It is possible to disinfect these accessories in boiling water for about 10-15 minutes. In order to avoid damaging the items, make sure that the water level used is always sufficient to cover them. An alternative is to use chemical sterilisation, which can be readily purchased in a pharmacy, suitable for the disinfection of plastic material (such as Milton, Amuchina etc.) All the nebuliser parts and the accessories (mouthpiece and connector) can be sterilised by autoclave. The cycles to be used are those recommended by the autoclave manufacturer for sterilising plastic and rubber material. The cycle used which is suitable for these materials is 121 C, 110 kpa (1.1 bar) for 15-20 minutes. At the end of the sterilising process, always allow the accessories and parts to cool completely to ambient air temperature before use. Replace the kit after 20 sterilising cycles. Filters The filters must not be cleaned but replaced. Our replacement guidelines are as follows: The large filter A must be replaced as soon as it becomes wet or dirty and at least weekly. The small filters B must be replaced when dirty and at least monthly. 9. REPLACING THE FUSE AND THE FILTER To replace the fuse, always disconnect from the mains, to avoid electrocution. Open the fuse holder under the electrical socket, on the base of the compressor. Remove the burnt out fuse, using a Philips screwdriver, and replace with a new one with the same electrical specification. ONLY use fuses of 5mm, 250V delayed, T 2A UNIKO-TPEP E is equipped with piston compressors incorporating a protective filter for the motors which must be replaced periodically (once a year). To replace the filter, the cover for this is positioned on the left hand side of the electrical socket, carefully lever the lid marked filter and replace. 10. TROUBLESHOOTING PROBLEM POSSIBLE CAUSE SOLUTION The device does not switch on (green LED not illuminated (8) ) The device is on but will not nebulise. The device is on but the pump for respiratory exercise does not work. The pump for respiratory exercise does not come on during the expiratory phase. Electrical cable not connected. Fuse not connecting. Aerosol therapy mode not selected. The nebuliser nozzle is not inserted. The nebuliser tube is bent or tangled. The air filter is blocked, There is no medication in the aerosol chamber. The aerosol chamber has been closed incorrectly. The TPEP tubing connected at outlet (4) is bent or tangled. The air filter is blocked. The tubing connected to the air sensor outlet (5) is bent or tangled. The air filter is blocked. Check that the cable is correctly inserted into the device and mains socket. Verify that the electrical supply is at the correct rating. Check the fuse and replace if necessary. Select aerosol therapy mode. Insert the nebuliser nozzle. Pull the tube carefully, without stretching it. Replace the air filter with a new one. Place the medication in the nebuliser chamber according to the prescription given by the clinician. Pull the tube carefully without stretching it, Replace the air filter with a new one. Turn the device off and then back on again. Pull the tube carefully without stretching it. Replace the air filter with a new one. Turn the device off and then back on again. The pump is always on. Possible re-setting of the transducer If the problem does not resolve itself, contact your sales/service representative. The pump is always on Air filter and/or tubing wet and/or dirty. Check the air filter and/or the tubing. They must be dry and clean. If not, replace them. Operator s manual UNIKO-TPEP E MPR118 Rev. 2-09/2010 Pag. 8 /12
The device does not work. Respiratory exercise too difficult or too easy, with the effort indicator not starting from zero. The thermal protection has cut in, because the device was operating too close to a heat source, or in an ambient temperature higher than 40 C The device is not calibrated. Allow the device to cool down and reach lower ambient temperatures for at least 30 minutes. Wait for 10 seconds without using the device and without turning it off, allowing the zero to re-calibrate automatically. 11. OPERATING CONDITIONS 12. TRANSPORT AND STORAGE Temperature: min. 10 C; max 40 C Humidity: min. 10%; max 95% Atmospheric pressure: from 860 hpa to 1060 hpa 13. TECHNICAL SPECIFICATION Model: UNIKO-TPEP E Power supply: 220-230V AC 50 Hz Absorption: 300VA Class, electrical protection: II Type : B Fuse: T2A 250V Dimensions and weight : 27 x 23 x 13 cm - 3,350 Kg Aerosol compressor MAX pressure : 300 kpa TPEP compressor Max pressure: 200 kpa Aerosol air flow:15 l/min TPEP air flow: 12 l/min Operating airflow from aerosol compressor: 7 l/min (at 90 kpa) Noise level: < 60 dba (1m distance, frontal position) Norm : CEI EN 60601-1 - CEI EN 60601-1-2 EN 13544 Conforms to: Medical Device Directive: 93/42/CEE Warranty: 24 months Conditions of transport and storage: Temperature: -20 C 60 C Humidity % : 10% 95% Atmospheric pressure: from 500 to 1060 hpa TECHNICAL SPECIFICATION OF THE AEROSOL CHAMBER Results of the measurements taken according to EN 13544-1 (without valve system) Operating Flow[l/min] 7,5 Fill Volume 4 ml 2,5%NaF MMAD 2,44 GSD 3,03 MMAD: Mass Median Aerodynamic Diameter GSD: Geometric Standard Deviation Results of the measurements taken according to EN 13544-1 with respiratory simulator (with valved system) Operating Flow[l/min] Fill Volume Output [µl] Output [µl/min] 7,5 2 ml 1%NaF 322,5 186 Distribution of cumulative mass expressed as a % Operating specifications advised: Operating flow 7,5 l/min (± 10%) Operating pressure 150 kpa (1,5 bar) (± 10%) Minimum fill volume 2 ml Maximum fill volume 16 ml 14. WASTE DISPOSAL Instructions for disposal are according to article 13 of Decree Legislation 25th July 2005, number 151 implementation of the Directive 2002/95/CE,2002/96/CE and 2003/108/CE, relative to the reduction in use of dangerous substances in electrical appliances and electronics, as well as waste disposal. Operator s manual UNIKO-TPEP E MPR118 Rev. 2-09/2010 Pag. 9 /12
The symbol of the bin, crossed through, indicates that at the end of its useful life the product should be collected separately to other refuse. Separate refuse collection and the end of the life of this product is organised and managed by the manufacturer. The user who wishes to dispose of this product at the end of its life must therefore contact the manufacturer (or their supplier as appropriate) and follow the system which they have adapted to comply with separate collection. The proper separate collection which is the start of the process of the device being classified ready for recycling, treatment and all compatible environmental disposal, contributes to avoiding possible negative effects on the environment and health and promotes the re-use and/or recycling of the materials which the product is made from. The abusive disposal of the product by the owner/holder of the product will bring into force the administrative sanctions laid down by the norms. The elimination of the kit components must be according to the national legislation and the hospital norms applicable for dangerous biological refuse. 15. CONDITIONS OF GUARANTEE Valid for 24 months from date of purchase CERTIFICATE OF GUARANTEE CONDITIONS OF GUARANTEE - The device is guaranteed 24 months from the date of purchase against any defect attributable to the material or its construction, on condition that it has not been interfered with by the customer or unauthorised personnel. - The guarantee covers the replacement or repair of the components related to the construction. - For reasons of health and hygiene the device will absolutely not be replaced as it is strictly a personal medical device. - The present guarantee does not include parts subject to normal wear and tear, and damage resulting from improper use, being dropped, transportation, lack of maintenance or causes which cannot be attributed to the manufacturer. - MPR declines all responsibility for any direct damage resulting from improper use or careless use of the product. - In case of breakdown, the device, property cleaned and packaged, must be sent by your dealer, enclosing this completed certificate of guarantee together with the purchase receipt; otherwise the guarantee will deemed invalid and owner will be changed for the work undertaken. - The return delivery costs of the device are the customer s responsibility. - MPR will not respond to any extensions to the period of guarantee covered by a third party. ATTENTION: THE GUARANTEE IS ONLY VALID IF COMPLETED AND ACCOMPANIED BY A RECEIPT/INVOICE. MOD.: UNIKO-TPEP E LOT NUMBER: SERIAL NUMBER: FAULT FOUND: Attach the sales receipt or purchase invoice Dealer (stamp and signature) 16. LIST OF ACCESSORIES AND REPLACEMENT PARTS Part number Item description UNIKIT PATIENT CIRCUIT KIT, SINGLE PATIENT USE, comprising: MPR22 AEROSOL CHAMBER FASTERJET MPR20 SMALL FILTER (2) filter B MPR19 LARGE FILTER filter A MPR9 MPR21 MPR6 MPR5 MPR11 MPR18 MPR16 MPR17 SILICONE TUBE 4cm (2) connects to the 2 small filters SILICONE TUBE 60cm (2) connects to the 2 small filters UNIVERSAL CONNECTOR (TO CONNECT THE SILICONE TUBES) CONNECTOR SPACER (ACE) VALVED MOUTHPIECE CLOSED MOUTHPIECE NEBULISER TUBING Operator s manual UNIKO-TPEP E MPR118 Rev. 2-09/2010 Pag. 10 /12
MPR14 MPR15 UNIKIT2 MPR102 MPR74 PLE005 AIR FILTER (POREX) NOSE CLIP PATIENT CIRCUIT KIT, SINGLE PATIENT USE, FOR RESPIRATORY EXERCISE ONLY Other accessories REPLACEMENT FUSE (T2A)INSERT IN THE FUSE HOLDER CARRYING BAG ELECTRICAL CABLE Only use original products. Replacing broken or worn parts with products of poor quality or manufacture, can compromise the function of the device in addition to rendering the guarantee null and void. Operator s manual UNIKO-TPEP E MPR118 Rev. 2-09/2010 Pag. 11 /12
Medical Products Research S.r.l. Via R. Cuttica, 43 20025 Legnano (MI) ITALY Tel + 39 0331 597 992 Fax: +39 0331 485 089 e-mail: info@mpr-italy.it - www.mpr-italy.it Operator s manual UNIKO-TPEP E MPR118 Rev. 2-09/2010 Pag. 12 /12