LumiFemTMoperating instructions
Contents
1. 625 630 nm P lt 30 mW Battery 2 x 1 5V AA e 12 2011 ce AOA Reimers amp Janssen GmbH FabrikstraSe 22 D 79183 Waldkirch R www LumiFem de e mail Kontakt LumiFem de SA Explanation of symbols C The device meets the requirements of Directive 93 42 EEC concerning medical 0123 devices IPXO No rating against harmful ingress of water as defined in IEC 529 Til Observe the accompanying documentation Device provides special protection from electric shocks especially in relation to A permitted leakage current 112 2011 Date of production Month Year Distributor STERIFEED Medicare Colgate Ltd Post Cross Business Park Unit 1 amp 2 Kentisbeare Cullompton Devon England EX15 2BB Tel 00 44 1884 266 666 info sterifeed com www sterifeed com Manufacturer REIMERS amp JANSSEN GmbH Medical Laser Technology Certified to EN ISO 13485 2003 Fabrikstrasse 22 79183 Waldkirch Germany Tel 0049 0 7681 493 4149 Fax 0049 0 7681 493 4150 kontakt LumiFem de www LumiFem de2. indicator on unit Button pressed 1 x Continuous wave mode LED lights up green J Button pressed 2 x Frequency mode WVA LED flashes green w Button pressed 3 x Sleep mode a LED off e Occurs automatically Battery charge low LED flashes red e Cleaning and disinfection The nipple covers are designed as disposable items and should be replaced after use We hereby explicitly draw your attention to the risk of infection if covers are re used However if you do re use the nipple covers rinse them out first with cold water and then with hot water For best treatment results new covers should be used each day After every use the LED adapters should be wiped with a sterile wipe Never pass on used nipple covers for another person to use When wiping clean the LumiFem control unit always use a sterile wipe Changing the batteries When the battery charge is low shown by the LED indicator flashing red the batteries must be changed This prevents treatments taking place with a lower light intensity Use only high quality AA batteries non rechargeable in order to prevent damage which can be caused by the batteries leaking To change the batteries see the instructions for inserting them as given on page 11 One set of batteries contains enough charge for about 200 treatments or for 6 months in sleep mode If you do not need to use the unit for more than 2 weeks take the batteries out Warr
3. LumiFem Nursing Without Pain a oo lt a TM Your LumiFem You have chosen a high quality state of the art medical product from Reimers amp Janssen one of Europe s leading manufacturers of low level laser and LED light therapy devices LumiFem light therapy offers an alternative treatment method free of side effects for sore and cracked nipples An easing of the pain and healing of cracking should become noticeable soon after even just a few treatments Contents Delivery contents 4 General information 4 Safety information and warnings 5 Withdrawal from use and Liability disclaimer 6 Action 8 Use 9 Instructions for use 10 Start up 11 Starting treatment 12 Changing the therapy program 13 Cleaning and disinfection 14 Changing the batteries 16 Warranty and disposal 17 Technical data 18 Delivery contents e LumiFem control unit e 2 LED holders with connecting cable e 2 batteries AA type e 10x 2 nipple covers General information Read these operating instructions thoroughly before operating the device The operating instructions describe the proper use of the LumiFem and indicate hazards associated with its use All individuals who use care for service or inspect this device must read and follow the instructions These operating instructions must always be kept with the device and must be included with the LumiFem if given to others Safety information and warnings The nipple cov
4. anty and disposal Manufacturer s warranty The manufacturer s warranty is valid for 24 months The manufacturer is responsible for the features of the LumiFem as warranted by the operating instructions if the device has been operated carefully and in accordance with the operating instructions The warranty does not cover the disposable hygiene sensitive items included with the product such as the nipple covers and carry bag Readjustment calibration and maintenance or repairs may only be performed by the distributor otherwise the warranty is void Any alterations to the device by unauthorised third parties void the warranty Disposal The LumiFem must be disposed of in accordance with legal requirements If you have any questions regarding these please contact your distributor Technical data Device LumiFem Battery operation IP rating IPXO Mass Dimensions Wavelength Power output Light intensity Half angle of beam 40 2x AA batteries 1 5V 180g 18x12 x8cm 625 630 nm 15 30 mW per LED 4000 8500 mcd per LED Functions and safety standards The LumiFem conforms to the following European safety standards EN 14971 2007 Medical devices risk management EN 60601 1 6 2007 Medical electrical equipment Parts 1 6 EN 62471 2009 Photobiological safety of lamps EN 13485 2007 Quality management systems 18 Nameplate LumiFem Phototherapiegerat Serial No 11430 07
5. egin treatment immediately as described on the following page Unlatch the lid on the back Insert the batteries put the Plug the connecting cable of the unit fold it up and lid back in position and latch from the LED holders into the remove it in place socket on the front of the unit 11 Starting treatment T i ee o Separate a pair of nipple Apply the cover to your Start the treatment program covers and fit an adapter breast avoiding direct simply by pressing the button onto each cover you wish to contact with injured skin as The LED indicator will light up use You may use one cover much as possible The LED green The therapy will stop or two as needed should not touch the nipple automatically after 5 minutes If the LED indicator does not light up or flashes red change the batteries IA Changing the therapy program The preset therapy program is a continuous wave program where the LED is lit continuously and emits maximum energy The LumiFem is also equipped with a frequency program where the LED lights up repeatedly in quick succession These biofrequencies are programmed according to the findings of acupuncture specialists Dr Elias Dr Nogier and Prof Bahr The energy emitted is half as much as with the continuous light program This therapy is activated simply by pressing the button a second time The LED indicator will flash Operating instructions Operating mode LED
6. ers are designed as disposable items and should be discarded after use The LED holders must be cleaned and disinfected before use The nipple covers must only come in contact with intact healthy skin Do not look directly at the light beam People who are sensitive to light should consult their doctor before treatment Store the device in a safe place out of the reach of children Do not operate the LumiFem in wet environments or with wet hands Risk of strangulation do not coil around the throat For use only on sore and cracked nipples or for prevention of mastitis inflammation of the breast In the case of an elevated temperature over 37 5 C consult a doctor or midwife immediately to rule out the possibility of mastitis If there is no improvement in the soreness or cracking after two days consult a doctor or midwife immediately Withdrawal from use in the event of a hazard If it appears likely that the device can no longer be operated without risk withdraw it from use secure it to prevent further use and send it to your distributor for repair or maintenance This must be done if e the device no longer functions properly e the LumiFem has been stored or transported for a long period under adverse conditions Liability disclaimer The LumiFem must be used only for the purpose described in this user manual The LumiFem must be operated only together with original accessory parts The manufacturer is not liable for the device and the c
7. onsequences resulting from operation or applications that are not described within these operating instructions The manufacturer reserves the right to make changes based on technological improvements Legal notice from the German Advertising of Medicines Law For legal reasons we hereby advise that none of the information given is intended to create the impression that a cure is promised here or that alleviation or improvement in afflictions and diseases are guaranteed or promised Action Sore nipples frequently lead to inflammation of the mammary glands mastitis which can often only be treated with antibiotics That carries the risk that the medication could enter the breast milk placing increased stress on the infant LumiFem regenerates the nipples by stimulating cell metabolism preventing inflammation in a natural way without any side effects or stress on your baby The cells of sore nipples often have an energy deficiency making them susceptible to infection They require an input of energy for regeneration In LumiFem light therapy a light emitting diode releases the required energy in the form of red light directly at the site of inflammation This stimulates cell metabolism and also allows damaged tissue to be removed more easily and new healthy tissue to form more quickly Use With LumiFem light therapy you can prevent interruptions to breastfeeding due to the pain of sore or cracked nipples Timely
8. therapy can also minimise the risk of mastitis inflammation of the breast and the possibility of abrupt weaning If used early treatment will normally take two to four days If irritation recurs when your baby resumes suckling on the nipple use should be resumed and continued until the nipples have regenerated LumiFem can also be used as a preventive measure so that soreness and cracking do not appear in the first place The risk of infection from mastitis pathogens will also be reduced from the outset One use takes 5 minutes and should be repeated 3 4 times daily ideally directly after breastfeeding so that your breast has time to regenerate before your next feed Instructions for use If you are using only one nipple cover set the other LED holder aside making sure that its light emitting diode LED is covered When applying the nipple cover make sure that neither the cover nor the LED in its holder come in direct contact with injured skin After every use the LED adapters should be cleaned with a sterile wipe Never pass on used nipple covers for another person to use If there is no improvement in the soreness or cracking after two days consult a doctor or midwife immediately Start up The LumiFem does not require a particular start up procedure You simply need to insert the batteries included with the device If you are hiring the unit the batteries may already be inserted If so you can b
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