User Manual - Mirage Health Group
Contents
1. EN 60601 1 2 GUIDE TO SYMBOLS o Class Ila Equipment Type BF Electrical safety A Attention Consult Accompanying Documents IPX1 Protected against water droplets E Single use item C Conforms to the Medical Device Directive 93 42 EEC European waste electrical and electronic X Must be disposed of in accordance with equipment directive 2002 96 EC OPERATING INSTRUCTIONS These instructions are for general use When required refer to Detailed Information in the second half of this manual Ensure thot the device is ONLY used by suitably trained clinicians Ensure that the warnings and cautions are observed Ensure that the patient exhibits no contra indications 7 Ensure the unit has been cleaned Mains electrical power is not necessary if the battery is adequately charged The device may be run connected to the mains electrical supply by the power supply provided Connect the footswitch provided The reservoir should be removed to fill Fill the reservoir to a maximum of 700ml with warm water at 40 C Check regularly to ensure temperature drop does not occur Refill as necessary Fit a new Propulse Disposable One Use Jet Tip to the handle Set Pressure ftlow to minimum Turn on the Footswitch Power Switch 7 to on marked I With the footswitch depressed check that the power status 9 is adequate green If the power status is not adequate amber or red indicator the Propulse Ill may be ru2. procedure is only carried out by a suitably trained nurse doctor or audiologist WARNINGS AND CAUTIONS This manual must be read and understood before the Propulse Ill is used Only suitably trained staff should use the device The Propulse Jet Tip is One Use dispose of after use The Propulse IIl must not be immersed in water Only clean the device as specitied in this manual See page 10 f any changes in performance occur disconnect from mains power turn off the Propulse III and do NOT use See page 11 The device has no user serviceable parts See page 11 Do not use with other manufacturers accessories or consumables Do not use Propulse Accessories with other devices f the device is to be used for domestic visits it is strongly advised that the Propulse Carry Case is used o prevent damage and contamination 4 The Propulse Ill Electronic Ear Irrigator is not user repairable and should be returned to your Propulse supplier or the Mirage Service Department UK customers only for service and or repair Please note Damage caused to your Propulse III by the use of non Propulse accessories consumables or service agents will invalidate your warranty DO NOT IRRIGATE the cars if Consent is not given and or the patient is uncooperative Previous complications occurred following this procedure There is a history of a middle ear infection in the last six weeks The patient has undergone
3. able One Use Jet Tips should be used with the Propulse III Ear rrigator Power Adaptor The Power Adaptor can be used to charge the internal battery or to run the device from the mains electrical supply Connect the outlet lead of the Power Adaptor to the Power Adaptor socket 11 marked on the end of the product and to the mains electrical supply Make sure the cord and Power Adaptor are positioned so that they will not be subjected to damage or stress or present a trip hazard Only use a Propulse Ill branded Power Adaptor To reduce the risk of electric shock unplug the unit from the power source before attempting to clean it externally The Power Adaptor must not be used outdoors or in damp areas The Propulse Ill Power Adaptor will have been supplied with an appropriate electrical plug If there are any problems connecting to the mains electrical supply consult a qualified electrician Battery Use And Care We recommend that the battery is fully charged for 24 hours before you use the Propulse III for the first time For subsequent use the battery will normally require 16 hours to fully charge A new battery or one that has not been used for a long time could have reduced capacity the first few times it is used The battery is integral and is only replaceable by a Mirage authorised battery replacement centre Refer to your Propulse supplier or the Mirage Service Department UK customers only It is recommended that the batte
4. d by the manufacturer The manufacturer cannot accept responsibility for damage or injury however caused through the use of non approved jet tip applicators Additional user manuals and other accessories are available from Mirage Health Group Ltd at MIRAGE HEALTH GROUP Ltd BioPark Hertfordshire Broadwater Road Welwyn Garden City Hertfordshire AL7 3AX UK Tel 0845 130 5440 Manufactured By MIRAGE HEALTH GROUP Ltd BioPark Hertfordshire Broadwater Road Welwyn Garden City Hertfordshire AL7 3AX UK Tel 0845 130 5440 EAR CARE TRAINING Uk only Mirage can advise on the availability of training courses offered by relevant organisations Mirage Health Group Ltd BioPark Hertfordshire Broadwater Road Welwyn Garden City Hertfordshire AL7 3AX UK Tel 0845 130 5440 Fax 0845 130 6440 Overseas Tel 44 845 130 5440 Fax 44 845 130 6440 www miragehealthgroup com uksales miragehealthgroup com internationalsales miragehealthgroup com cE 0499 PURACE HEALTH GROUP Copyright Mirage Health Group Ltd September 2006 WHL 060809
5. e optimum performance the Propulse Ill Electronic Ear Irrigator should be serviced every 12 months Service or repairs conducted by unauthorised agencies organisations invalidate any or implied warranties from Mirage The Propulse Ill should under go routine electrical safety testing to ensure that it remains safe to use Users of the Propulse III should carry out regular inspections to ensure that the handle and hose Power Adaptor and cable reservoir and main body of the machine are free from damage prior to use If any damage is evident the Propulse IIl should NOT be used until replacement parts have been fitted Only Propulse branded items should be used with the Propulse Ill The Propulse Ill Electronic Ear Irrigator is not user repairable and should be returned to your Propulse supplier or the Mirage Service Department UK customers only for service and or repair MIRAGE SERVICE DEPARTMENT 53 Purbeck Drive Lostock Bolton Lancashire BL6 4JF Tel 0845 130 5445 The clinical procedures relating to the use of ear irrigators can be found on the following websites www earcarecentre com www entnursing com earcare htm Mirage is not responsible for the content or maintenance of third party internet sites Mirage can also advise on the availability of training courses offered by the relevant organisations Warranty The manufacturer cannot accept responsibility if the Propulse Ill is used for any purpose other than that intende
6. ear surgery apart from grommets that have extruded at least 18 months previously and the patient has been discharged from the ENT dept e The patient has a perforation or there is a history of a mucous discharge in the last year f The patient has a cleft palate repaired or not g Inthe presence of acute otitis externa an oedematous ear canal combined with pain and tenderness of the pinna h If patient complains of pain STOP IMMEDIATELY DESCRIPTION Komop 2 1 Water Container Reservoir 7 Footswitch Power Switch Marked for indication only 8 Charging Mains Power light 2 Propulse Disposable One Use Jet Tip 9 Power Status light 3 Handle 10 Footswitch Socket 4 Lid 11 Power Adaptor Socket 5 Water Jet Stop Button 12 Footswitch 6 Pressure Flow Control Knob The Propulse Ill Electronic Ear Irrigator consists of a The main unit with integral battery and User Controls A Footswitch Power Switch 7 this switch powers the equipment on I and off O in conjunction with the footswitch See d below A water pressure flow control knob 6 A water jet stop button 5 on the handle See c below Charging Mains Power Light 8 illuminates green when connected to mains power by the Power Adaptor Power Status Light 9 illuminates when the Propulse is turned on Note The tricolour light merges from one colour to the next Green when there is adequate p
7. f 0 PULSE Lit UNIVERSAL The fully portable electronic ear irrigator User Manual English Language Version cE 0499 PAD ALE HEALTH GROUP Professional Ear Care with Integrity PRO 2 0 ES sa esa Professional Ear Care with Integrity Propulse Henckel Propulse Jobson Horne style style forceps 3 probe 1 1mm Propulse Hartmann style Fropulse Wax Mook crocodile forceps Propulse R R Noots Tank dressing scissors Propulse Tilley style aural dressing forceps PRO 20 BS EE EEN Professional Ear Care with Integrity Propulse Disposable One Propulse Cleaning Tablets Use Jet Tips packs of 100 Propulse Carry Case makes domiciliary visits even simpler Pr pulse Headlamp PRO aU BS 5 Replacement Washers amp Valves Replacement Reservoir INTENDED PURPOSE The Propulse Ill Electronic Ear Irrigator is intended to a Facilitate the removal of cerumen and foreign bodies which are not hygroscopic from the external auditory meatus b Remove discharge keratin or debris from the external auditory meatus by irrigation with warm water Reasons for using this procedure are to a Correctly treat otitis externa where the meatus is obscured by debris b Improve conduction of sound into the ear where impacted wax is believed to be the cause of a hearing defect c Examine the external auditory meatus and the tympanic membrane d Remove a cause of discomfort We recommend this
8. n connected to the mains electrical supply by the Power Adaptor provided Adjust the water pressure flow to appropriate value compatible with the treatment requirements and patient comfort Direct the irrigator tip into the noots tank and switch on the machine for 10 20 seconds in order to circulate the water through the system and eliminate any trapped air or cold water Ensure water is warm before presentation to the patient During treatment you can pause the flow by releasing the footswitch or pressing and holding the Water Stop button on the handle 5 After treatment empty the reservoir and operate the device to purge residual water Remove the Propulse Disposable One Use Jet Tip and dispose of to clinical waste Turn off Footswitch Power Switch 7 after use and connect to Power Adaptor to recharge the battery if required Clean the Propulse Ill unit every morning prior to use with a cleaning tablet See page 10 The Propulse III should only be transported in a Propulse approved Carry Case to prevent damage or contamination If any changes in the performance of the Propulse III occur it should be disconnected from mains power and should NOT be used Please refer the machine to the Mirage Service Department See page 11 8 DETAILED INFORMATION Fitting the Footswitch The Propulse footswitch is connected to the main unit by a socket 10 in the side of the device The Propulse III Universal ear irrigator
9. ower from battery or mains Amber battery power level is low and will need to be recharged soon Red connect to mains via the Power Adaptor Battery needs recharging immediately Water container reservoir 1 is removable for filling and cleaning Graduations are for indication only Handle 3 and non detachable hose The handle accommodates Propulse Disposable One Use Jet Tips The handle incorporates a water jet stop button 5 This button will stop the flow of water when it is pressed and held fully in The flow of water will resume on release of the button providing the footswitch is pressed The footswitch 12 is connected to the main body via a jackplug socket connection 10 The device will only function if the footswitch is connected Pressing the footswitch causes the device to pump water through the Propulse Disposable One Use Jet Tip at the pressure flow set by the pressure flow control knob 6 TECHNICAL DATA Performance Static Pressure Minimum setting 0 27 1 1 bar Maximum setting 1 35 3 45 bar Water jet pulses 1200 per minute approximately Maximum operating time 10 minutes continuous use with a recommended rest time of 2 hours Storage temperature range 5 C to 65 C Storage relative humidity Up to 80 Rechargeable Battery 6v Ni MH 1300 mAh Power Adaptor Input 100 240v 50 60Hz Max 0 48A Output 9V DC 1 5A Electrical Safety EN60601 1 EMC Compliance
10. ry is replaced after 400 charge cycles Environmental Protection This symbol on the products and or accompanying documents means that use electrical and electronic products should not be mixed with general waste Please return to Mirage Health Group Penalties may be applicable for incorrect disposal of this waste in accordance with national legislation Disposing of used Propulse Disposable One Use Jet Tip Disposal should be in accordance with local regulations and guidelines for the disposal of clinical waste Propulse Disposable One Use Jet Tips should not be placed in municipal waste Transportation Before the Propulse Ill is transported the reservoir must be emptied and the machine should be run until the handle and hose are empty of liquid The reservoir should then be dried using a paper towel The Propulse Ill should only be transported in a Propulse approved Carry Case to prevent damage or contamination Cleaning Do not attempt to clean the Jet Tip Use one Propulse Disposable One Use Jet Tip per patient treatment and discard to clinical waste after use as this reduces the risk of cross infection between patients External cleaning should be done by hand wiping with a damp cloth only Apply liquids to the cloth not the unit Do not immerse the unit in water Mild detergents and disinfectants may be used externally Internal cleaning of the Propulse III Electronic Ear Irrigator pumps and waterways PRIOR to u
11. se 1 Place one Propulse cleaning tablet into the reservoir fill with warm water to the 500ml mark on the reservoir and wait for tablet to completely dissolve 2 Run the Propulse Ill Electronic Ear Irrigator for a few seconds to fill the pump and hose 3 Leave to stand for 10 minutes 4 Empty the reservoir of the solution then fill the reservoir with cool boiled water or well run cold tap water and flush through the whole system to ensure no cleaning solution is left 5 This cleaning procedure should be used prior to each days usage of the ear irrigator 6 DO NOT leave the solution in the unit for longer than stated Cleaning Tablets for the Propulse Ill Electronic Ear Irrigator the importance of using the correct strength cleaning solution cannot be overstated A solution that is too strong will in time damage the Propulse and one that is too weak will fail to provide the correct level of cleaning and decontamination To this end the manufacturer has introduced a simple to use effective specific strength CHLOR CLEAN decontamination tablet Propulse cleaning tablets are available from your normal Propulse supplier or direct from Mirage UK only Please note Damage caused to your Propulse Ill ear irrigator by not using the recommended cleaning agent will invalidate your warranty Other instruments used with Propulse Ill should be cleaned according to local guidelines 10 Maintenance amp Safety Inspections To ensur
12. will NOT operate unless the footswitch is connected Filling the water container It is recommended that i The water container reservoir 1 is removed from the device for filling and that the lid is always in place when the water container is in situ on the device ii The water reservoir must NOT be filled over the 700ml marking to eliminate the risk of spillage The graduations marked on the reservoir are for indication only iii Water above 40 C should NOT be used in order to avoid the risk of scalding and burns to the user and patient Water below 40 C should NOT be used in order to avoid the risk of patient discomfort and dizziness Fitting the Propulse Disposable One Use Jet Tip applicators The Propulse Ill Electronic Ear Irrigator is supplied with ten Propulse Disposable One Use Jet Tip applicators Use one Propulse Disposable One Use Jet Tip per treatment To fit a Jet Tip applicator push the Jet Tip applicator directly into the handle without using a sideways movement To remove a Jet Tip applicator pull the jet tip applicator directly from the handle without using a sideways movement Propulse Disposable One Use Jet Tips are available in boxes of 100 individually wrapped tips from your normal Propulse supplier or from from Mirage direct UK only Propulse Disposable One Use Jet Tips are clearly branded with the Propulse logo on the tip and it s packaging Only Propulse branded Dispos
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