User Manual
Contents
1. b by operation outside the usage parameters stated in the user documentation that shipped with the product c by software interfacing parts or supplies not supplied by MTTS d improper site preparation or maintenance e virus infection f loss or damage in transit or g by modification or service by anyone other than i MTTS ii an MTTS authorized service provider or iii your own installation of end user replaceable MTTS or MTTS approved parts if available for your Phototherapy in the servicing country or region Limitation of Liability IF YOUR MTTS PHOTOTHERAPY FAILS TO WORK AS WARRANTED ABOVE THE MAXIMUM LIABILITY OF MTTS UNDER THIS LIMITED WARRANTY IS EXPRESS LY LIMITED TO THE LESSER OF THE PRICE YOU HAVE PAID FOR THE PHOTOTHERAPY OR THE COST OF REPAIR OR REPLACEMENT OF ANY HARDWARE COMPONENTS THAT MALFUNCTION IN CONDITIONS OF NORMAL USE EXCEPT AS INDICATED ABOVE IN NO EVENT WILL MTTS BE LIABLE FOR ANY DAMAGES CAUSED BY THE PHOTOTHERAPY OR THE FAILURE OF THE PHOTOTHERAPY TO PERFORM INCLUDING ANY LOST PROFITS OR SAVINGS OR SPECIAL INCIDENTAL OR CONSEQUENTIAL DAMAGES MTTS IS NOT LIABLE FOR ANY CLAIM MADE BY A THIRD PARTY OR MADE BY YOU FOR A THIRD PARTY THIS LIMITATION OF LIABILITY APPLIES WHETHER DAMAGES ARE SOUGHT OR A CLAIM MADE UN DER THIS LIMITED WARRANTY OR AS A TORT CLAIM INCLUDING NEGLIGENCE AND STRICT PRODUCT LIABILITY A CONTRACT CLAIM OR ANY OTHER CLAIM THIS LIMITATION OF LIABILITY CA2. e xi Cr MTTS Medical Technology Transfer and Services Firefly phototherapy User Manuat Effective date May 2015 Issue Number 01 Version 03 TH Issue Date March 2015 WWW rntts asia com Contents Company Information Introduction Quick start guide Components Power supply Control panel Warnings Safety information Cleaning and disinfection Irradiance measurement Irradiance measurement criteria Specifications Explanation of Symbols Warranty Policy Firetly User manual 04 05 06 07 08 20 21 Company Information Medical Tochnelogy Transfer and Servicos MEDICAL TECHNOLOGY TRANSFER AND SERVICES Co LTD House No 26 Alley 41 An Duong Vuong Street ay Ho District Hanoi City Vietnam Tel 84 24 3766 6521 Fax 84 24 3718 8050 Email assistancel dmtts asia com www mtts asia com PROMETEO SRL Via Mantova 9 38122 Trento Ec REP Italy 04 Introduction Phototherapy is one of the simplest and safest methods to treat Jaundice in neonatal intensive care Untreated jaundice leads to an excessive level of bilirubin in the blood which may potentially result in brain damage or death What does phototherapy do Reduces the bilirubin level in the blood through Photo oxidation Configurational isomerisation Structural isomerisation Phototherapy starts medical treatment immediately after it s turned on It emits very little heat because
3. 1 F J i m Fa lu 2 E d i 4 i s Pa i on 7 e 4 n d kt at F b J a um d kn i s T m Fa wd a r A C a ai Pal a Pa x kt b a P P d d is p E b Pal E ty a ra S E i E d d p E DO NOI carry the Firefly while the patient is in the device DO NOT place the patient directly on the window of the lower light DO NOI place the Firefly inside an incubator DO NOI use Firefly phototherapy with an MI TS infant warmer or any other warmer as this will cause damage to the Firefly top light MrTS EL IEELL LL e Safety Information Always cover the patients eye s with a shield or patch whenever the patients eye s can be exposed to the Firefly s light Periodically you may want to ensure that the babys eyes are protected and infection free Patients bilirubin values should be measured regularly while undergoing phototherapy treatment To accurately assess the babys skin colour turn off the light when checking the babys condition Regularly monitor the patient s temperature and fluid status amp Q DO NOT disassemble any part of the Firefly phototherapy excluding the removal of the bassinet Q DO NOT place the Firefly in direct sunlight Note In the event of a power outage eye coverings should be left on the patient whenever they are inside the Firefly to protect the patient s eyes in case the power returns Y MT TS Firefly User manual ELI LJ Safe
4. 9096 RH non condensing Atmospheric Pressure 70 106kPa Transport and storage Ambient temperature 10 C to 85 C Humidity 096 to 9096 RH non condensing Atmospheric Pressure 70 106kPa Exclusions Not for use inside an incubator and or any radiant warmer Standards for Reference EN 60601 1 2006 AC2010 3rd edition Medical electrical equipment Part 1 General requirements for basic safety and essential performance EN 60601 1 2 2007 AC2010 Medical electrical equipment Part 1 2 General requirements for basic safety and essential performance Collateral standard Electromagnetic compatibility Requirements and tests EN 60601 2 50 2009 Medical electrical equipment Part 2 50 particular requirements for the basic safety and essential performance of infant phototherapy equipment EN 60601 1 6 2010 Medical electrical equipment Part 1 6 General requirements for basic safety and essential performance Collateral standard Usability biocompatibility tests Skin sensitization as per ISO 10993 Part 10 Cytotoxicity direct contact as per ISO 10993 Part 5 Primary skin irritation as per 150 10993 Part 10 Y MTT Firefly User manual Explanation of Symbols Please refer to User Manual before operating this device Do not disassemble the Firefly unless you are an MI TS trained technician or have been instructed to by qualified personnel excluding the removal of the bassinet An eye patch should always be placed on th
5. of the LED light source so does not cause dehydration Phototherapy with Firefly Firefly double sided LED phototherapy equips you to deliver high intensity phototherapy to treat this potentially hazardous condition Li b MIT Firefly User manual h MTTS Components 1 Top Light Blue light shines onto the top side of the patient 2 Bassinet A removable plastic bassinet is used to carry the patient and hold the patient during treatment 3 Control Panel ON OFF button and the display which shows treatment time and total device hours 4 Lower Light Blue light shines through a window onto the under side of the patient 5 Heat sink Heat from the LED light source escapes from below the Firefly ensuring the device remains at a safe operating temperature 6 V 03 TH M TS Bee Up my P 4 Power Supply 12 V DC i O Plug in and Power up The connector plugs into the back of the Firefly and then directly into the power outlet in the wall 100 240 V AC AN Only use the cable and connector that is provided by MTTS AN The Firefly should only be used with the power outlets that have a protective earth ground pin MTTS Firefly User manual Q7 ELI LJ Control Panel he control panel is located at the front of the Firefly device The image above shows the control panel which consists of 1 Power button Turns the device ON and OFF 2 Display Shows the treat
6. that the device is functioning properly regularly monitor the Firefly in the following way Measurement instructions To test the irradiance of the Firefly measure using a lightmeter specifically designed to measure wavelengths for phototherapy A stabilization time of 2 hours of continuous operation is required for accurate measuring of the irradiance When measuring the bottom light cover the top light with an opaque material Measure each of the sections of the bassinet seen in the adjacent picture Compare the measurements to the expected values assuming some decay over time When measuring the top light cover the bottom light with an opaque material Prop up the lightmeter 5 cm from the bottom of the bassinet to achieve the surface area seen in the adjacent picture Measure the irradiance of the Firefly in each of the sections seen in the adjacent picture YMTTS doas Geo be ees ace jue cem Irradiance measurement criteria The lights will decay gradually over time reaching approximately 70 of their original irradiance at 44 000 hours Note that the irradiance should be measured when the device has reached 44 000 hours After 44 Q00 hours the device should be replaced with a new one 53cm 20 86 in 24cm 9 44 in TOP LIGHT IRRADIANCE uW cm nm BOTTOM LIGHT 20cm 7 87 in L D IM Firefly User manual r Bpr e Foam pa d Specifications Perf
7. CULAR PURPOSE IS LIMITED TO THE DURATION OF THE EXPRESS WARRANTY SET FORTH ABOVE SOME STATES OR COUNTRIES DO NOT ALLOW A LIMITATION ON HOW LONG AN IMPLIED WARRANTY LASTS OR THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES FOR CONSUMER PRODUCTS IN SUCH STATES OR COUNTRIES SOME EXCLUSIONS OR LIMITATIONS OF THIS LIMITED WARRANTY MAY NOT APPLY TO YOU FOR CONSUMER TRANSACTIONS THE LIMITED WARRANTY TERMS CONTAINED IN THIS STATEMENT EXCEPT TO THE EXTENT LAWFULLY PERMITTED DO NOT EXCLUDE RESTRICT OR MODIFY BUT ARE IN ADDITION TO THE MANDATORY STATUTORY RIGHTS APPLICABLE TO THE SALE OF THIS PRODUCT TO YOU This Limited Warranty is applicable in all countries and may be enforced in any country or region where MTTS or its authorized service providers offerwarranty service for the same product model number subject to the terms and conditions set forth in this Limited Warranty Under this MTTS Limited Warranty products purchased in one country or region may be transferred to another country or region where MTTS or its authorized service providers offer warranty service for the same product model number Warranty terms service availability and service response times may vary from country or region to country or region Standard warranty service response time is subject to change due to local parts availability If so your MTTS authorized service provider can provide you with details MTTS will not alter form fit or functi
8. NNOT BE WAIVED OR AMENDED BY ANY PERSON THIS LIMITATION OF LIABILITY WILL BE EFFECTIVE EVEN IF YOU HAVE ADVISED MTTS OR AN AUTHORIZED REPRESENTATIVE OF MTTS OF THE POSSIBILITY OF ANY SUCH DAMAGES THIS LIMITATION OF LIABILITY HOWEVER WILL NOT APPLY TO CLAIMS FOR PERSONAL INJURY THIS LIMITED WARRANTY GIVES YOU SPECIFIC LEGAL RIGHTS YOU MAY ALSO HAVE OTHER RIGHTS THAT MAY VARY FROM STATE TO STATE OR FROM COUNTRY TO COUNTRY YOU ARE ADVISED TO CONSULT APPLICABLE STATE OR COUNTRY LAWS FOR A FULL DETERMINATION OF YOUR RIGHTS YMTTS Warranty Policy Limited Warranty Period The Limited Warranty Period for an MITTS Phototherapy is a specified fixed period commencing on the date of purchase and specified on the Phototherapy Warranty Card The date on your sales receipt is the date of purchase unless MTTS or your reseller informs you otherwise in writing Customer Responsibilities In order to avoid the risk of charges for issues not covered by your limited warranty issues that are not due to defects in materials and workmanship on MTTS Phototherapy you will be asked to assist MTTS as follows e Verify configurations load most recent firm ware install software patches run MTTS diag nostics and utilities e Implement temporary procedures or workarounds provided by MTTS while MITTS works on permanent solutions e Cooperate with MTTS in attempting to resolve the problem using online chat email or tel phone This may in
9. be free from defects in material or workmanship for ninety 90 days or for the remainder of the Limited Warranty Period of the MTTS Phototherapy they are replacing or in which they are installed whichever is longer MTTS will at its sole discretion repair or replace any component or Phototherapy that manifests a defect in materials or workmanship during the Limited Warranty Period All component parts removed under this Limited Warranty become the property of MTTS In the unlikely event that your MTTS Phototherapy has recurring failures MTTS at its sole discretion may elect to provide you with a a replacement unit selected by MTTS that is the same or equivalent to your MTTS Phototherapy in performance or b to give you a refund of your purchase price or lease payments less interest instead of a replacement This is your exclusive remedy for defective products Exclusions MTTS DOES NOT WARRANT THAT THE OPERATION OF THIS PRODUCT WILL BE UNINTERRUPTED OR ERROR FREE MTTS IS NOT RESPONSIBLE FOR DAMAGE THAT OCCURS AS A RESULT OF YOUR FAILURE TO FOLLOW THE INSTRUCTIONS INTENDED FOR THE MTTS Phototherapy This Limited Warranty does not apply to expendable or consumable parts and does not extend to any product from which the serial number has been removed or that has been damaged or rendered defective a as a result of accident misuse abuse contamination improper or inadequate maintenance or calibration or other external causes
10. e patient before commencing treatment DO NOI use Firefly phototherapy with an MI TS infant warmer or any other warmer as this will cause damage to the Firefly top Light Keep out of direct sunlight This device should be disposed of separately from normal household waste so that components can be recycled Device manufacturer Date of manufacture Power supply polarity 12V DC 5A 12 Volts Direct Current 5 Ampere C C CE Logo with Notified Body Number 2265 Warranty Policy General Terms This MTTS Limited Warranty gives you the customer express limited warranty rights from MTTS the manufacturer for the duration specified on the Warranty Card Please refer to the MTTS Web site for an extensive description of your limited warranty entitlements In addition you may also have other legal rights under applicable local law or special written agreement with MTTS MTTS MAKES NO OTHER EXPRESS WARRANTY OR CONDITION WHETHER WRITTEN OR ORAL AND MTTS EXPRESSLY DISCLAIMS ALL WARRANTIES AND CONDITIONS NOT STATED IN THIS LIMITED WARRANTY TO THE EXTENT ALLOWED BY THE LOCAL LAW OF JURISDICTIONS OUTSIDE THE UNITED STATES MTTS DISCLAIMS ALL IMPLIED WARRANTIES OR CONDITIONS INCLUDING ANY IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE FOR ALL TRANSACTIONS OCCURRING IN THE UNITED STATES ANY IMPLIED WARRANTY OR CONDITION OF MERCHANTABILITY SATISFACTORY QUALITY OR FITNESS FOR A PARTI
11. ment time as well as total device hours of Firefly usage 08 gt Control Panel 1 Plug in the Firefly The device recognises the connection by illuminating every LED on the Control Panel display also one red light under the main window will illuminate This will be displayed for just a few moments before returning to a blank screen 2 Turn on the Firefly The display shows the total device hours The total device hours is a multiple of 10 of what is actually displayed This will be displayed for 3 seconds This example shows 17 500 hours 3 he blue phototherapy lights will now Start to shine The display will start counting the treatment time This example shows minute 4 he phototherapy treatment will continue until the doctor decides therapy is no Longer necessary and the device can be switched OFF The treatment time will remain on the display for a few minutes This example shows 72 hours 30 minutes CY MTT e Firefly User manual oH 5 oet mw Warnings Error messages In the case that the Firefly has a minor error then the error number will be displayed on the control panel If such an error occurs this message will appear for 5 seconds after the device Is connected to the power supply but before the Firefly is switched on The Firefly is still safe to operate however please contact MI TS and quote the error number and device serial number This er
12. on of this MTTS product to make it operate in a country for which it was never intended to function for legal or regulatory reasons MTTS is not responsible for any tariffs or duties that may be incurred in transferring the products MTTS guarantees that the MTTS Phototherapy that you have purchased or leased from MTTS is free from defects in materials or workmanship under normal use during the Limited Warranty Period The Limited Warranty Period starts on the date of purchase or lease from MTTS or from the date MTTS completes installation Your dated sales or delivery receipt showing the date of purchase or lease of the product is your proof of the purchase or lease date You may be required to provide proof of purchase or lease as a condition of receiving warranty service You are entitled to hardware warranty service according to the terms and conditions of this document if a repair to your MTTS Phototherapy is required within the Limited Warranty Period Unless otherwise stated and to the extent permitted by local law new MTTS Phototherapy may be manufactured using new materials or new and used materials equivalent to new in performance and reliability MTTS may repair or replace MTTS Phototherapy a with new or previously used products or parts equivalent to new in performance and reliability or b with equivalent products to an original product that has been discontinued Replacement parts are Warranty Policy warranted to
13. ormance Specifications Illumination source Peak wavelength Lamp duration Average spectral irradiance top light bottom light Effective surface area top light bottom light Irradiance Uniformity Ratio top light bottom light Time Totalizer Measured with Physical Specifications Key features Dimensions LxWxD overall top light bottom light Total unit mass Electrical Specifications Power characteristics Off the shelf external power supply High power blue LEDs 1 1 25W standard operating 490 470 nm LEDs rated to last 44 000 hours at max temperature 32 4 uW cm2 nm 36 5 uW cm2 nm Socmoc24 m 53 cm x 23 cm 20 9 in x 9 4 in 48 cm x 20 cm 18 9 in x 7 8 in 0 51 IEC Compliant gt 0 4 0 72 IEC Compliant gt 0 4 48 cm x 20cm Treatment time and total device hours Ohmeda Biliblanket No moving parts Enclosed designed toward NEMA Type 5 66 cm x 38 cm x 49 5 cm Zoin x 4 9in x 12 9 f 31 6 cmix 12 9 Cr 6 5 em 0 3in x 4 9in x 2 5in 25 9In x 15in x 3 9in 13 kg 28 7lbs 64 7 cm x 38 cm x 10cm 60W 100 240VAC 47 63Hz International medical safety approvals ANSI AAMI EN 60601 1 UL TUV Class construction is standard ground required 100k hours MTBF Energy Star Efficiency Level V compliant RoHS 2 compliant Over voltage over current protection YmtTtTs am Paes ey bu Specifications Environmental Specifications Operating Ambient temperature 10 C to 35 C Humidity 096 to
14. r other anaesthetics oooon PRP KP PP BP b Sensitive individuals may experience headache nausea or mild vertigo if he she stays too long in the illuminated area Using the Firefly in a well lighted area or wearing glasses with yellow lenses can alleviate potential effects Guard Dog Bones glass es p n 413BB are recommended and are available online at www safetyglasses com Ymtts k lne I M Cleaning and disinfection he Firefly bassinet should be disinfected before and after the treatment of each patient In the case that a patient undergoes treatment for more than one week then be sure to disinfect the bassinet once a week If visibly soiled clean the affected parts with soap and water using a soft cloth Then wipe with a wet cloth and dry with a soft cloth For difficult areas use a standard soft bristled brush To loosen heavy dried on soil you may first need to saturate the spot with water Only disinfect the bassinet with a solution containing at least 70 alcohol Apply the disinfectant with a clean cloth or soft sponge Wait for the device to dry after cleaning or disinfecting before use C N When cleaning the device disconnect the power cord d i p f T a SON Q DO NOT use alcohol to disinfect any other part of the device Q DO NOI immerse any part of the device in water or alcohol Ym TTS Firefly User manual ELA Pres ee be Irradiance measurement Note to ensure
15. ror number will help the MI TS technical team identify and solve the problem The image above shows when exactly in the start up process the error message will be displayed N General warning n the rare occurrence that the Firefly experiences a more serious error which results in the blue lights to turn off then immediately remove the patient from the device as they will not be receiving any phototherapy An error code will be shown on the display panel this error will most likely correct itself and the Firefly will automatically turn back on and resume therapy if not please contact MI S and report the error code to MI TS YMTTS LE E oo Warnings N LED lifetime warning Ihe blue LEDs in the Firefly are rated to provide effective treatment for 44 000 hours After turning ON the Firefly the display will show the total device hours This particular example shows 44 000 hours At 44 000 hours and anytime after 44 000 hours a red light under the lower window of the Firefly will flash for a few moments before the phototherapy starts this indicates that the LED s have reached the recommended life span The blue phototherapy lights will turn ON and the treatment will start as normal The display will show the treatment time again Note The estimated 44000 hour life span is equal to a full 5 years of non stop use After this period of time the LED phototherapy lights will continue to function however treatment
16. ty information The Firefly phototherapy should be used only by appropriately trained personnel and under the direction of qualified medical personnel familiar with currently known risks and benefits of infant phototherapy equipment use Patients adjacent to the infant phototherapy equipment may need to be protected with protective shields or eye protection The operator may experience some effects during prolonged exposure to the area Irradiated by the infant phototherapy equipment Blue light can hinder clinical observations by masking skin colour changes such as cyanosis An infants water balance may be Influenced by phototherapy Regular feeding times may need to occur more often in order to prevent dehydration Varying the ambient conditions ambient temperature and or different radiation sources may negatively affect the patient Refer to your hospital phototherapy policy and procedure regarding appropriate ambient conditions Bilirubin photoisomers may be toxic Do not use the Firefly if it appears that any part of the device is not functioning properly or if any parts appear damaged Contact MI TS In case of any malfunction DO NOI attempt to service this machine the Firefly should only be serviced by a qualified MI TS technician Due to photo effects drugs and infusion liquids should not be stored in the radiation area Do not use the in the presence of potentially combustible gases including oxygen nitrous oxide o
17. volve performing routine diagnostic procedures installing additional software updates or patches e Perform additional tasks as defined within each type of warranty service listed below and any other actions that MTTS may reasonably request in order to best perform the warranty support YMTTS L IARI EMI Contacting MTTS If your Phototherapy fails during the Limited Warranty Period and the suggestions in the Phototherapy documentation do not solve the problem you can receive support by doing one of the following e Locate and contact your nearest MTTS Support location via the World Wide Web at http www mtts asia com en support warranties e Contact your MTTS authorized service provider e Call the Technical Support Center at 84 43 766 6521 Before calling MTTS or an MTTS authorized service provider please have the following information available e Phototherapy serial number model name and Phototherapy model number e Applicable error messages e Detailed question ul Cutts MEDICAL TECHNOLOGY TRANSFER AND SERVICES Co LTD House No 26 Alley 41 An Duong Vuong Street Tay Ho District Hanoi City Vietnam Tel 84 24 3766 6521 Fax 84 24 3718 8050 Email assistance d mtts asia com www mtts asia com PROMETEO SRL Via Mantova 9 ra er 38122 Trento Italy MTTS Medical Technology Transfer and Services
18. will be significantly less effective and the Firefly should be replaced Y MTTS Firefly User manual Safety Information When using Firefly phototherapy the patient should ALWAYS be placed in the bassinet Jf The Firefly has been designed so that the bassinet Is removable The patient should be placed in the bassinet then the bassinet into the device to ensure patient comfort and safety ja 4 r i f i i Hd Al i p Fi p hs Li v L p 7 FO Tow f W FEL Jl ka EL zd p Ti pa dl E f Fi Pal i T P a a pa i Pl s ke ei E e s i s r B a ra Y 1 Li A p t Fi kS ri la L w A i b 0 k or Y A Fi ET h i 1 ai j x i A an i H 4 4 C w T ME x Fi i 1 F fa l PA a NN 1 dd lj j Fi rl 4 i w Et ad rj ri i F f P M Pd Fil fo j hy A I l uw P Lo 1 t E EN e a CN i ii 2 M a a a ttt I V P i p 1 s a iF a a a Ps us A Cy i E a I r o 4 T F ot J i F AA ae Pers VU AER X i 4A PLE cx A k w CN c P yf 4 ur a il i a r p yo e E d i a if C NX on 2 d OT dM NX Of A E r rw E a on a fi d E P QUU ur 1 LT hc z m i t i z y P hy e t Iun Tt Pa F Ur j f a P e 2 F ay L d E d i I L F E i j j a Pa
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