Nebulizer with Micromesh Technology GT Instruction manual

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Transcription:

Nebulizer with Micromesh Technology GT-7002 Instruction manual

Dear customer, Thank you for your confi dence in Geratherm and congratulations on your purchase! By purchasing the Geratherm micromesh nebulizer you have acquired a quality product by Geratherm. Please read these instructions for use carefully to use the device without problems and enjoy your Geratherm nebulizer for a long time. Best Regards, The Geratherm Team 24

Table of Contents Item Supplied and Packaging... 26 Features... 26 Descriptions of Parts... 27 Safety Precautions... 28 Important Information about Inhalation Therapy and Mesh Technoloy, purpose of use... 29 Important Information about Inhalants/Medications... 29 Preparation before Use/ Operation... 30 Battery Replacement... 30 Operating Instructions... 30 Important Information before Use... 30 Unit Assembly and Usage...31 Inhalation with Mouth Piece and Masks... 33 Cleaning and Disinfection... 34 Before Cleaning... 34 Cleaning and Disinfection of Nebulizer Parts/ Accessories... 34 Cleaning and Disinfection of Nebulizer Unit... 35 Maintenance... 36 Changing Accessories... 37 Troubleshooting... 38 Technical Data... 39 Symbol Information... 40 Disposal... 41 Limited Warranty... 41 Warranty Card... 42 25

Items Supplied and Packaging Before you start to use the Geratherm micromesh, please check if the following items are included in the package: 1 nebulizer Geratherm micromesh GT-7002 with nebulizer unit, mesh cap, adapter (for masks and mouth piece) and cover 1 mouthpiece* 1 PVC mask adult* 1 PVC mask children* 2 AA batteries 1.5 V 1 storage bag 1 instruction manual * Note For reasons of hygiene, please use the enclosed masks and mouth piece for one specifi c individual only and do not exchange them. The masks and the mouth piece must be cleaned after each use as described in the section entitled Cleaning and Disinfection of Nebuliser Parts/ Accessories. Only silicon masks, which are available from specialist suppliers, can be disinfected by boiling or by means of vaporisation (at 100 C for approx. 10 minutes). Use only the parts listed above; use of other parts may constitute a hazard. Features Discharge-proof - fully operative even when positioned on an inclined surface (up to 45 ) No warming of medicine, thus preventing damage to the structure of the medication Low power consumption Convenient design compact and lightweight, ideal for travelling Silent operation thanks to the micromesh technology Short treatment time with high nebulization rate No medication cups necessary (no disposable items) 26

Descriptions of Parts PVC masks (adult + children) Unit lid Mouth piece adapter (for masks and mouth piece) 2 AA Alkaline batteries Nebulizer unit Mesh cap Medication cup Indicator: green: usage red: battery needs to be replaced green and red: reset the vibration rate Battery cover ON/OFF button 27

Safety Precautions Use the equipment only for its intended use as described in this manual. Do not use attachments not recommended by the manufacturer. Use the equipment with medications only under the instruction of your physician. Do not use the equipment if it has any damaged parts, or it has fallen into water/ other liquids. Remove the batteries when not in use for a long period of time to avoid circuit damage due to leakage from battery. To use the equipment for the fi rst time, or after storing it for an extended period, be sure to clean and sterilize all necessary parts as described in the cleaning instructions. Do not use while bathing. The unit should not be left unattended while plugged in or turned on. Keep the unit out of reach of small unsupervised children. The small parts detached from the device may result children choking from inhaling or swallowing. The accessible materials used in the device will not cause the potential allergic reactions to skin. Do not try to modify the device to prevent any dangers. Do not place the device in liquid, nor put it where it could fall into liquid. If the device becomes wet, unplug the device before touching it. Do not use the device if it is not working properly, or if it has suffered any damage. Do not subject the nebulizer or the mesh cap to any impacts and do not drop them. Before using the nebulizer for the fi rst time, after a period of no use, and after every use, please clean all removable parts of the nebulizer. Before storing, please make sure all parts are clean and dry. Do not expose the nebulizer to direct sunlight, high temperatures or high humidity. The device is intended for private domestic use only. To guarantee an effective inhalation, just inhale with mask or mouth piece. 28

Important Information about Inhalation Therapy and Mesh Technology, Purpose of Use Geratherm micromesh is suitable for the treatment of asthma, chronic bronchitis and other respiratory conditions affecting the upper and lower airways, e.g. the common cold. The medication is nebulized by means of an ultra-modern vibrating membrane or mesh. This membrane is partially porous, enabling tiny droplets of the inhalant to penetrate it as soon as it begins vibrating. The key component of this system is the mesh cap. We recommend replacing the cap approx. after six months when in regular use in order to ensure effi cient nebulization. The device is ideally suitable for inhalation at home or when travelling. It guarantees highly effective, fast-acting inhalation treatment for patients of all ages. Carry out inhalation in a quiet and relaxed state, and inhale slowly and deeply, so that the medication can penetrate to the fi ne, deep bronchial tubes. Exhale normally. Important Information about Inhalants/ Medications Please only use the medicinal products/medication prescribed for you by your doctor. The Geratherm micromesh nebulizer is suitable for use with all common aerosol products for medical use with the exception of - viscous solutions (high viscosity) - suspensions (products with solid constituents) - volatile oils Attention: Use only water-soluble medicines or aerosol products which have an alcohol base. 29

Preparation before Use / Operation The nebulizer is powered by two 1.5V AA alkaline batteries. Battery Replacement Replace batteries when the red indicator blinks. Before replacing the batteries, make sure that the nebulizer is turned off. 1. Press the buckle on the battery cover and lift up to remove the cover. 2. Remove the used batteries. Insert two new ones. Correctly align the polarities (+ and -) with battery indication marks on the device. 3. Close the battery cover by pressing down fi rmly until a click is heard. Note: Remove the batteries if not using the device for three months or longer. Discard the used batteries according to your local regulations. Operating Instructions Important Information Before Use Ensure that all parts are clean or disinfect if necessary and dry. Before starting treatment, talk to your physician about the duration, dosage and frequency of use of the nebulizer. The green indicator is on during nebulization. The device turns off automatically after 15 minutes of non-use (without the ON/OFF button being pressed). Do not remove the medication cup cover from the unit during nebulization. 30

Operating Instructions Unit Assembly and Usage 1. Remove the unit lid and the mesh cap of the nebulizer. Remove the mesh cap by gently pressing on the protruding plastic fl ap. The cover can then be pulled upwards and lifted off. 2 1 2. Slowly pour the prescribed medication into the medication cup. The maximum capacity of the medication cup is 6 ml. Please note that the medication must not exceed this maximum level marking (6 ml). 3. Slide the mesh cap into the unit, align the 2 knobs with the cutouts in the direction indicated by arrow 1. Then press the cover down until it clicks into place. 1 2 4. Attach the adapter on the mesh cap. Please pay attention that the knobs of mesh cap are in the same position as the cuttings of adapter. Click the adapter into mesh cap. Now attach the unit lid. 31

Operating Instructions 5. Attach the mask or the mouthpiece to the adapter: or 6. Take the nebulizer in your hand and press the ON/OFF button to begin nebulization. You can select one of two delivery modes. Please read the following section concerning this. 7. To end the nebulization, press the ON/OFF button to turn it off. Delivery mode The nebulizer provides you with two delivery modes according to your needs: automatic or manual. Automatic delivery of aerosol 1. Press and release the ON/OFF button. The unit turns on and starts to deliver the prescribed medication continuously for 15 minutes. The nebulizer will turn off automatically after 15 minutes of non-use (without the ON/OFF button being pressed). 2. To stop the treatment at any time, press the ON/OFF button again to turn off the device. 32

Operating Instructions Manual delivery of aerosol In the manual mode, the duration of nebulization is controlled by holding down the ON/OFF button. 1. Press the ON/OFF button down for more than 2 seconds. The unit will start with nebulization. 2. When you want to fi nish the process, release the ON/ OFF button and the device will stop delivering medications. Inhalation with Mouth Piece and Masks Inhalation using the mouthpiece 1. Place the mouthpiece in your mouth with the lips sealed around the mouthpiece. 2. Switch on the unit. 3. During treatment, take slow, deep breaths through your mouth. If possible, hold each breath for two to three seconds before breathing out. This allows the medication to settle into the respiratory system. 4. Continue the treatment until the medication has been used up (about 10 to 15 minutes). 5. If you become dizzy, stop the treatment and rest for about fi ve minutes. Then continue the treatment, but try to breathe more slowly. If these symptoms continue with future treatments, inform your physician. 6. Clean and disinfect if necessary like described below. Inhalation Using the Mask 1. Place the mask over your mouth and nose. 2. Switch on the unit. 3. During treatment, take slow, deep breaths through your nose. If possible, hold each breath for two to three seconds before breathing out. This allows the medication to settle into the respiratory system. 4. Follow the procedures described under Inhalation using the mouthpiece. 33

Cleaning and Disinfection Please clean your device after each use according to the instructions below. Note: After two uses (inhalations) please rinse the nebulizer with water by fi lling the medication cup with water in order to clean the membrane. Before Cleaning Make sure that the nebulizer is turned off before disassembly. 1. Remove the unit lid, mask, mouthpiece and adapter from the unit. You could remove the adapter from mesh cap by slightly turning in clockwise direction. 2 1 2. Remove the mesh cap by gently pressing the fl ap and lifting up in the direction indicated the arrows. 3. Discard any remaining medications (pay attention to statutory provisions). Cleaning and Disinfection of Nebulizer Parts/ Accessories Cleaning after every use Clean the mask, mouthpiece, unit lid, adapter and mesh cap after each use. 1. Disassemble the components from the unit. 2. Rinse all above-named parts under a small stream of tap water. 3. Gently wipe off excess water with a clean dry cloth and allow to air dry. Possible remained drops on the mesh surface could remove by easy shaking of mesh cap. 34

Cleaning and Disinfection Daily disinfecting Disinfection by boiling: 1. Silicon masks and mesh cap can be disinfected by boiling in distilled water. 2. After 10-20 minutes of boiling, gently wipe off excess water with a clean dry cloth and allow to air dry on a clean paper towel. Disinfection by using alcohol: 1. PVC mask, mouthpiece, unit lid and mesh adapter can be disinfected by using medical alcohol (Ethanol 75% dilution with water). 2. Disinfect the above-named parts by wiping with a cloth moistened with medical alcohol (Ethanol 75% dilution with water). 3. Let them air dry on a clean paper towel. Note: Only silicon mask can be disinfected by boiling, PVC mask just can be disinfected by using medical alcohol 75% (dilution with water). Cleaning and Disinfection the Nebulizer Unit Cleaning after every use 1. Use a cloth moistened with water to clean the medication cup and outer casing of the unit. 2. Wipe off the unit with an unused dry cloth and let it air dry. Daily disinfecting 1. Use a cloth moistened with medical alcohol (Ethanol 75% dilution with water) to disinfect the medication cup and outer casing of the unit. 2. Let them air dry on a clean paper towel. 35

Cleaning and Disinfection CAUTION Do not immerse the nebulizer unit in any liquid and do not hold it under running water. Be careful to ensure that no water penetrates the nebulizer unit. Do not clean the nebulizer or its component parts in a dishwasher. Do not allow any moisture to come into the battery compartment. Do not use any other disinfectant like described above to clean the unit or its components. Do not use a hairdryer to dry any parts. Maintenance When using a new mesh cap for the fi rst time, you need to reset the vibration rate: 1. Pour water into the medicine cup (pay attention to maximum marking). 2. Attach the mesh cap to the nebulizer unit. 3. Take the batteries out. 4. While holding down the ON/OFF button, reinsert the batteries and close the battery cover. 5. Keep the unit upright and then release the ON/OFF button. The green and red indicator light up, indicating that the nebulizer is resetting the vibration rate. 6. After a few seconds, the nebulizer automatically turns off. The vibration rate resetting is fi nished. The nebulizer is ready for use. The unit must be kept upright during this procedure. 36

Changing Accessories We recommend that the mesh cap be replaced after about 6 months of use if the unit is used daily (once per day), so as to ensure effi cient nebulization. This recommendation is based on a content volume of 2 ml and an inhalation time of about 8-15 minutes. The possible use time of 6 months could shorten if the unit is used often daily. The accessories should be replaced after continuous use. Accessories of the nebulizer micromesh involve: mesh cap, mesh adapter (for masks and mouth piece), PVC masks (for adult and children), silicon masks (for adult and children), and mouth piece. Accessories are available in specialist shop. description article number EAN mesh cap 9730002017 4018674000215 PVC adult mask PVC children mask silikon adult mask silikon children mask 9730002012 4018674000161 9730002011 4018674000154 9730002014 4018674000185 9730002013 4018674000178 mouth piece 9730002016 4018674000208 connecting piece/ adapter 9730002015 4018674000192 37

Troubleshooting What happened The indicator turns red. The device does not work when it is turned on The indicator is green but no aerosolis produced or the delivery is slower than usual. There is medication in the medication cup and the ON/OFF button has been pressed, but no aerosols are being produced. Causation The batteries have run out of power. The mesh cap is dirty. No power. The medication cup is empty. The mesh cap is broken. The medication cup or the mesh cap is dirty. No power supply. The mesh is covered with liquid. Correction Replace the batteries. Clean the mesh cap. If the problem persists, please replace with a new mesh cap. Check the batteries and replace them if necessary. Pay attention to polarity. Fill medication cup and turn on the nebulizer. Replace with a new mesh cap. Clean those parts or replace mesh cap. Check the batteries and replace them if necessary. Pay attention to polarity. Check if the mesh cap is covered with liquid. If yes, shake off the liquid and then try again. 38

Technical Data Dimensions 76 mm x 60 mm x 135 mm Weight 190 g Power source 2 x AA alkaline batteries (1.5 V) Battery life Over 7 hours operating Power consumption 1.5 W Vibration frequency 185.5 khz Nebulization rate >0.25 ml/min Medication capacity 6 ml Operating conditions 10 C to 40 C, 30 to 85 % relative humidity Storage conditions -25 C to 70 C, up to 93% relative humidity IP code (protection rating): IP22 (effective against bigger solid bodies; protected gainst dripping water) Automatic function Automatic power shut-off if system idles for 15 minutes Power consumption Normal mode: less than 1.5 W Standby mode: less than 0.3 mw Quality standard The device complies with the Council Directive 93/42/EEC concerning medical devices. A quality management system certifi cated under DIN EN ISO 13485 guarantees compliance with the required quality criteria. EN 13544-1 respiratory therapy equipment part 1: nebulizing systems and their components Distribution of particle size (with mask and mouth piece): 1,0 Volumenanteil/ Volume fraction 0,8 0,5 0,3 0,0 0 5 10 15 20 Partikelgröße/ Particle size [μm] 39

Symbol Information Symbol Referent Consult instructions for use Use by/expiry date for masks Batch code for nebulizer Manufacturing date of masks Manufacturer Serial number Caution, consult acompanying documents Do not dispose of as household waste Type BF Equipment 40

Disposal Adhere to the applicable regulations when disposing of the device and packaging. This product must not be disposed of in domestic waste. All users are obliged to hand in all electrical or electronic devices, regardless of whether or not they contain toxic substances, at a municipal or commercial collection point so that they can be disposed of in an environmentally acceptable manner. Please remove the batteries before disposing of the device/unit. Do not dispose of old batteries with your household waste, but at a battery collection station at a recycling site or in a shop. Limited Warranty This ultrasonic nebulizer is guaranteed for 3 years from the date of purchase. If your nebulizer does not function properly due to defective parts or assembly we will repair it free of charge. All parts are covered by this warranty, except accessories which are subject to normal wear and tear. The warranty does not cover damage to your unit due to improper handling. 41

Warranty Card The Geratherm micromesh nebulizer is guaranteed for three years from the date of purchase against manufacturer s defect if it is returned to the dealer from whom it was purchased. During this warranty period the unit will be repaired or replaced free of charge if the defect is due to faulty design or manufacture. This guarantee does not cover any damage or malfunctioning that is caused through improper handling, through use otherwise than in accordance with the instructions in this manual or through unauthorised maintenance attempts. Your local dealer cannot declare this manufacturer s warranty null and void, but may extend it by additional guarantees at the discretion and at the expense of the dealer. Model no.:..................................... Serial no.:..................................... Date of purchase:............................... Dealer s signature:.............................. Invoice no. / Receipt no.:.......................... Dealer s name and address:....................... Geratherm Medical AG Fahrenheitstraße 1 D-98716 Geschwenda Germany Tel: +49 36 205 980 Fax: +49 36 205 116 www.geratherm.com 42