Philips 1045219 Electric Toothbrush User Manual
Contents
1. BiliT x Parents Manual PHILIPS REF 1045219 H906104521909 PHILIPS Children s Medical Ventures Manufactured for ec REP Philips Children s Medical Ventures Respironics Deutschland C 191 Wyngate Drive Gewerbestrasse 17 Monroeville PA 15146 82211 Herrsching Germany 0086 2010 Koninkijike Philips Electronics N V All rights reserved Bili Tx parents manual Table of Contents OVERVIEW a azotanu entente ea anane o an o a uen 3 aiant Ee MUE E E E E EA What is the BiliTx Phototherapy System Components of the BiliTx SYSTEM nr 2 Warnings Cautions and SYMbOIS ssssscssseccsseecseeccssesessecessecsssecssscesnscesseeesuscessseesseeseseecsneessneessaeees 5 War MNO si ai air A osuiaserastasedde0uenssisecvusvscai aided E NE tds 5 CAUTION Si isir ee E E Ea are aN iTia 6 SYMONS aachen hen RE nE Enn an R RONNE 7 bie l b oe sees ncvacevdessatssetewstaseusegsidossdtiseoasarscassscrsdenssensdddvagesieoasdesdetesteaiseasensadeasteceseastt 9 Setup Wrap Around Panel 10 Setup Flat Neonatal Panel A Cleaning een agent Renee Cleaning the Illuminator Device and Fiber Optic Panel nn 13 Customer Service Information 14 5 MFOUDIESINOOTLIAG saxszessctsdavecsaesczscesrssteviaxiats uaa ta die Matsa eek nn mme 6 SPECINCATIONS i ina e ar a Environmental ei siek e e eine Physical en nennen Illuminator Fiber Optic Panel LIGNE Sources energie pren ren2. x 2 92 in 16 10 cm x 7 40 cm Weight lt 2 50 Ib 1 13 kg Fiber Optic Panel Model EG 2000 Wrap Around Panel Overall Pad Size Standard 4 00 x 15 00 10 16 cm x 38 10 cm Illuminated Area Standard 3 00 x 14 00 7 62 cm x 35 56 cm Model EG 2000N Flat Neonatal Panel Overall Pad Size Neonatal 5 00 x 7 00 12 70 cm x 17 78 cm Illuminated Area Neonatal 4 00 x 6 00 10 16 cm x 15 24 cm 18 Light Source Irradiance Level Standard Panel Light 30uW cm2 nm Neonatal Panel Light 55uW cm nm Intensity Ratio Standard Panel and Neonatal Panel gt 4 minimum to maximum Audible Noise lt 60 dB A Measured in accordance with IEC 60601 2 50 Standards Compliance This device is designed to conform to the following standards e IEC60601 1 General Requirements for Safety of Medical Electrical Equipment e IEC60601 2 50 Requirements for the Safety of Infant Phototherapy Equipment e Electromagnetic Compatibility EN 60601 1 2 2nd edition Electrical Requirements Type of Protection Against Electrical Shock Class Equipment Degree of Protection Against Electrical Shock Type BF Applied Part Degree of Protection Against Ingress of Water Ordinary Protection IPXO AC Power 100 240 VAC 50 60 Hz 1 0 Disposal Dispose of this device in accordance with local regulations BiliTx Parents Manual Bili Tx parents manual Appendix A EMC Information Guidance and Manufa
3. WITH ANV MEANS OF ARTIFICIAL HEAT Wipe the Illuminator device and panel with a dry cloth If the in use carrving case becomes soiled it can be wiped with a damp cloth CAUTION Be sure the Illuminator device is turned off and is unplugged before cleaning Do not immerse any part of the equipment in anv liquid CAUTION Keep the fiber optic panel away from sharp objects that could scratch or puncture the cover A warn nG When cleaning DO NOT USE e Phenolic compound based germicide cleaner disinfectant Gluteraldhyde disinfectant sterilants Regular commercial cleaners or laundry detergents lodine solutions strong acids or strong alkali solutions These solutions could leave residue on the surfaces and or be abrasive or harmful to the infant 14 Customer Service Information If you need to contact Philips Children s Medical Ventures directly call the Philips Children s Medical Ventures Customer Service department at 1 800 345 6443 or 1 724 387 4000 Vou can also use the following address Children s Medical Ventures LLC 191 Wvngate Drive Monroeville Pennsylvania 15146 USA BiliTx Parents Manual HELPFUL TIP Visit Philips Children s Medical Ventures web site at www philips com childmed Bili Tx parents manual 5 Troubleshooting The following is a list of problems that may occur while using the BiliTx system For additional information contact your home care
4. be covered by anything except with the disposable cover provided Any other type of cover could cause a reduction in light intensity The setup instructions must be followed exactly This panel is ideal for preemie or underweight infants it may also be used on full term infants 1 The protective cover for the neonatal panel is a T vest Slide the vertical section of theT with the light facing the sheer side of the cover onto the panel hook and loop tabs Neonatal panel with t vest 2 Laythe covered panel on a flat surface Be sure the light emitting side is facing up 3 Position the baby s chest or back directly on the panel The cable connected to the panel should be between the baby s legs 4 Secure the T vest to the baby by first wrapping the side without the tape or hook and loop tab around the baby s midsection Then wrap the side with the tape or hook and loop tab over the infant If using tape peel off the protective cover on the tab and secure it Be sure the vest is snug Positioning the baby on the panel Chapter 3 Setup 12 5 If your cover has the hook and loop tabs you can secure the cover by pulling the hook and loop tab on the bottom corner of the cover up and accross the cover tightening the cover around the cable between the baby s legs 6 If the T vest becomes soiled discard it and replace it with a new one NOTES For a larger or more active baby you may want to tape
5. surface or using the carrying case hang the unit on the outside of a crib or the treatment area away from any heat source Make sure it is no more than four feet from where the baby will be positioned Insert the metal end of the light panel cable called the ferrule with the metal post facing up into the opening on the Illuminator unit Push the ferrule in and rotate it counter clockwise to lock into place The light will not come on if the panel is not inserted in the Illuminator device Plug the Illuminator device into an electrical outlet The power button will flash green CAUTION If the power cord or wires need repair or replacement do not connect the device 5 Press the Therapy On Off button to turn the Illuminator device on and begin phototherapv The Therapv button will illuminate green To turn off the device when therapv is complete press and hold the Therapv On Off button for 3 seconds warn nG After treatment has begun the baby s bilirubin level should be measured to make sure therapv is effective CAUTION Do not block anv of the air vents on the Illuminator device Connecting the light panel cable to the illuminator device Turning on the illuminator device Setup Wrap Around Panel This section explains how to prepare your baby for a phototherapv treatment using the wrap around fiber optic light panel The fiber optic panel must NOT be covered by anything except wit
6. ben Irradiance Level rennes Intensitv Katie i iii ii Base gada ea qa tt aa Audible Noise Standards Compliance Electrical Requirements ses 18 Disposal iss isse it o sein 18 Appendix A EMC Information inner 19 Bili Warran ER RE EEE EL A RRA ER aai 23 BiliTx Parents Manual Bili Tx parents manual 1 Overview This chapter explains how the BiliTx Phototherapy System is used to treat infant jaundice and it lists the components of the BiliTx system Intended Use The BiliTx is intended to treat hvperbilirubinemia through phototherapy What is the BiliTx Phototherapy System The BiliTx phototherapv system uses blue light emitting diodes LEDs to convert bilirubin to waste products that are mostly excreted through urine and stool thus reducing the bilirubin level in the baby s blood The Illuminator device sends light out of the fiber optic cable to the entire area of the panel The panel is inserted into a protective cover This wrap is soft and comfortable and allows the therapeutic light to be emitted towards the baby With this use of the BiliTx system the baby can be held and fed and enjov the healing comfort of parents while treatment is administered Additionally when the BiliTx system is properlv used with the fiber optic panel the baby s eyes do not need to be protected as with conventional phototherapy Components of the BiliTx System The BiliTx system may include the following components N
7. cturer s Declaration Electromagnetic Emissions This device is intended for use in the electromagnetic environment specified below The user of this device should make sure it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF emissions Group 1 The device uses RF energy only for its internal function CISPR 11 Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The device is suitable for use in all establishments CISPR 11 BTI including domestic establishments and those directly Harmonic emissions Class A connected to the public low voltage power supply IEC 61000 3 2 network Voltage fluctuations Flicker Complies emissions IEC 61000 3 3 Appendix A EMC Information Guidance and Manufacturer s Declaration Electromagnetic Immunitv This device is intended for use in the electromagnetic environment specified below The user of this device should make sure it is used in such an environment Immunitv Test Electrostatic Discharge ESD IEC 61000 4 2 Electrical Fast Transient Burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supplv input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 IEC 60601 Test Level 6 kV contact 8 KV air 2 kV for power supply lines 1 kV for input out
8. etic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above the device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the device b Over the frequency range 150 kHz to 80 MHz the field strengths should be less than 3 V m Appendix A EMC Information 22 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and this Device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of this device can help prevent electromagnetic interference bv maintaining a minimum distance between portable and mobile RF communications equipment transmitters and this device as recommended below according to the maximum output power of the communications equipment Rated Maximum Power Separation Distance According to Frequency of Transmitter Output of Transmitter m W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2 P d 1 2 P d 234P Do gt o o T S For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter w
9. ghts under this warrantv contact vour local authorized Philips Children s Medical Ventures dealer or contact Philips Children s Medical Ventures at 191 Wvngate Drive Monroeville PA 15146 USA 1 800 345 6443 24
10. h the cover provided Any other type of cover could cause a reduction in light intensity The setup instructions must be followed exactly This panel provides full coverage around the baby s torso 1 Place a disposable or reusable cover onto the panel with the light emitting side of the panel facing the sheer side of the cover ESF hook and loop tabs 2 Place the covered panel under the baby s torso positioning it so it is under the baby s armpits 3 Wrap the panel around the baby Use the tape or hook and loop tabs to secure the panel around the babv 4 Ifthe disposable cover becomes soiled discard it and replace with a clean one The cloth cover may be washed with mild soap and water NOTES For a larger or more active baby you may want to tape the panel to the baby s diaper To be sure the panel is not wrapped too tightly insert your finger between the panel and the baby s body Your finger should fit easily You may wrap the baby in a blanket or put the baby in a sleeper A warnine If using tape to secure the panel do not adhere the tape to the baby s skin BiliTx Parents Manual Wrap around panel with disposable cover Positioning the fiber optic panel Wrapping and securing the panel 11 Setup Flat Neonatal Panel This section explains how to prepare a baby for a phototherapy treatment using the flat neonatal fiber optic light panel The fiber optic panel must NOT
11. here P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people BiliTx Parents Manual Bili Tx parents manual BiliTx Warranty Children s Medical Ventures LLC warrants your Bili7x Phototherapy System against defects in material and workmanship of the Illuminator device and the fiber optic panels EG 2000 and EG 2000N for a period of one 1 year from the date of purchase In addition Philips Children s Medical Ventures warrants the LED light engine for 20 000 hours This warrantv does not cover anv damage to the illuminating device or the fiber optic panel caused bv accident misuse tampering or negligence such as failure to follow the instructions provided in this guide In the event your phototherapy illumination unit fails to give satisfactorv performance within the warrantv period and conditions Philips Children s Medical Ventures will repair or replace vour illuminating device at no charge for parts or labor The foregoing warranties are in lieu of all other warranties expressed or implied including without limitation anv implied warrantv of merchantabilitv or fitness for a particular purpose To exercise vour ri
12. ithout first unplugging the cord Discontinue use of the device and contact your home care provider e Never operate the Illuminator device if it has a damaged plug or damaged or frayed power cord or wires Do not insert anything into the end of the plug e Do not use an extension cord e Always connect the device to a properly grounded outlet If therapy is interrupted for any reason resume therapy as soon as possible and contact your home care provider Carefully place the panel cable to avoid entanglement Position the Illuminator device on a stable surface preferably lower than the infant When the BiliTx system is used with the fiber optic panel configuration and carrving case the device can hang on the outside of a crib or treatment area Do not place the Illuminator device power supply or carrving case in an incubator or infant warmer Do not place a temperature sensor for the infant warmer or incubator under the fiber optic panel Do not place the Illuminator device power supply or carrying case in a crib or other treatment area next to the baby Never block the air vents of the unit or place it on a soft surface such as a bed crib carpeted floor or couch where the air vents may be blocked During phototherapy the the baby s water balance may become disturbed Before and during phototherapy make sure the baby is properly hydrated and that his or her body temperature is maintained After treatment has begun the bab
13. mmunitv Test IEC 60601 Test Compliance Electromagnetic Environment Guidance Level Level Portable and mobile RF communications equipment should be used no closer to any part of the device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Conducted RF 3 Vrms Recommended separation distance IEC 61000 4 6 150 kHz to 80 MHz d 1 2P 150 kHz to 80 MHz Radiated RF 3V m IEC 61000 4 3 80 MHz to 2 5 GHz i 80 MHz to 800 MHz 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey 4 should be less than the compliance level in each frequencv range P Interference mav occur in the vicinitv of equipment marked with the following symbol A NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagn
14. ote that some components may vary from those shown below or may be optional accessories that are not packaged with your device BiliTx Parents Manual Fiber Optic Light Panel Configuration 1 Illuminator Device with AC Power Cord 2 Fiber Optic Panel 3 Disposable Cover 4 Illuminator Device Carrying Case 5 System Carrying Case optional not shown 6 Parents Manual not shown 7 Quick Start Guide not shown Fiber Optic Light Panel Configuration Contents Bili Tx parents manual 2 Warnings Cautions and Svmbols Caution US federal law restricts this device to sale by or on the order ofa physician Warnings A warn nG A warning indicates the possibility of injury to the user or manual operator Bilirubin photoisomers may cause toxic effects e Use the BiliTx only for its intended use as described in this Do not leave the Illuminator device on when the fiber optic panel is not around the baby Always turn off and unplug the Illuminator device during cleaning or servicing Do not use the BiliTx system in the presence of flammable substances such as anesthetics cleaning agents or gases that support combustion e g oxygen nitrous oxide e Do not use while bathing the baby Do not place or store the BiliTx system where it can fall or be pulled into a tub or sink e Ifthe Illuminator device falls into water or if fluid is spilled on the device do not reach for it w
15. provider or contact Philips Children s Medical Ventures Customer Service at 1 800 345 6443 or 724 387 4000 warninG If therapy is interrupted for one hour or longer resume therapy as soon as possible and contact your home care provider Problem Reason Action Therapy On Off button is not Check to make sure power cord is properly attached and green plugged into an active electrical outlet Ensure the device is turned on Therapy On Off button is not If the power cord is properly attached and plugged into an flashing green active electric outlet and the Therapy On Off button is not flashing green but the device will turn on continue to use the device for therapy Light is not being emitted from Check to make sure panel is securely locked into Illuminator fiber optic panel device Yellow LED is flashing Ensure the panel or circuit support adapter is securely locked into place If light continues to flash contact your home care provider Loss of power or light source Contact your home care provider failure Device will not turn off when Press and hold the Therapy On Off button for 3 seconds the Therapy On Off button is pressed 16 BiliTx Parents Manual Bili Tx parents manual 6 Specifications Environmental Storage Operating Temperature 4 to 122 F 20 to 50 C 59 to 95 F 15 to 35 C Relative Humidity 15 95 Non condensing 15 95 Non condensing Physical Illuminator Size 6 34 in
16. put lines 1 kV differential mode 2 kV common mode lt 5 U gt 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 dip in U for 25 cycles lt 5 U gt 95 dip in U for 5 sec Compliance Level 6 kV contact 8 kV air 2 kV for supply mains 1 kV for input output lines 1 kV differential mode 2 kV for common mode lt 5 U gt 95 dip in U for 0 5 cycle 40 U 50 dip in U for 5 cycles 70 U 30 dip in U for 25 cycles lt 5 U gt 95 dip in U for 5 sec NOTE U is the a c mains voltage prior to application of the test level BiliTx Parents Manual Electromagnetic Environment Guidance Floors should be wood concrete or ceramic tile If floors are covered with svnthetic material the relative humiditv should be at least 30 Mains power qualitv should be that of a tvpical home or hospital environment Mains power qualitv should be that of a tvpical home or hospital environment Mains power qualitv should be that of a tvpical home or hospital environment Power frequencv magnetic fields should be at levels characteristic of a tvpical location in a tvpical hospital or home environment 21 Guidance and Manufacturer s Declaration Electromagnetic Immunitv This device is intended for use in the electromagnetic environment specified below The user of this device should make sure it is used in such an environment I
17. the panel to the baby s diaper To be sure the panel is not wrapped too tightly insert your finger between the panel and the baby s body Your finger should fit easily You may wrap the baby in a blanket or put the baby in a sleeper A wannina If using tape to secure the panel do not adhere the tape to the baby s skin Using the In Use Carrying Case An optional in use carrying case is available for use with the Illuminator device The carrying case allows for easy mobility during phototherapy treatment To place the carrying case on the Illuminator device simply slide it over the device and adjust the position so that the Start Stop button is visible The shoulder strap should be located at the same end as the power cord You can adjust the shoulder strap as necessary using the hook and loop tabs Therapy On Off Button BiliTx Parents Manual Wrapping and securing the T vest Bili Tx parents manual 4 Cleaning This section explains how to clean the BiliTx system Cleaning the Illuminator Device and Fiber Optic Panel Follow the instructions in this section any time the Illuminator device or fiber optic panel is dirty 1 2 5 Use soapy water a 10 bleach solution or full strength ammonia Use a soft sponge or cloth to apply the cleaner Apply the cleaning solution to the sponge or cloth and wipe down the fiber optic panel and Illuminator Allow the equipment to air drv DO NOT DRV
18. y s bilirubin level should be measured to make sure therapy is effective The fiber optic panel must not be covered by anything except with the cover provided Any other type of cover will cause a reduction in light intensity The setup instructions must be followed exactly Cautions Annan e e Keep the unit away from any heated surface A caution indicates the Do not scratch damage or soil the ferrule end of the panel possibility of damage to the Also do not place sharp or heavy items on the panel this device can damage the panel and affect its light output Do not dry the fiber optic panel with artificial heat If the device is dropped contact your home care provider BiliTx Parents Manual Svmbols The following symbols appear on the BiliTx system Symbol Explanation Consult accompanying instructions for use Type BF applied part European Declaration of Conformity 0086 Therapy On Off ANTERTE Canadian US Safety Certification Conforms to ANSI UL STD 2601 Certified to CAN CSA C22 2 STD NO 601 1 c US LISTED 3158805 Lock and Unlock Chapter 2 Warnings Cautions and Symbols BiliTx Parents Manual Bili Tx parents manual 3 Setup Setting Up the BiliTx System 1 Place the appropriate cover on the panel and position the babv and panel as described later in this chapter See Setup Wrap Around Panel or Flat Neonatal Panel Place the Illuminator device on a hard flat
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