Nestophot user manual_GRX.PUB
Contents
1. S A Salcedo 5 28034 Madrid Spain Tel 34 1 358 16 25 C 6 Fax 34 1 358 08 69 www guidorx com e mail guidorx guidorx com Phototerapy Unit NESTOPHOT Serial number User s and Service Manual 20 GUIDO RAYOS X S A NESTOPHOT MAN 002 Jan 08 Ed 2 Rev 1 GUIDO RAYOS X S A 21 MAN 002 NESTOPHOT Jan 08 Ed 2 Rev 12. 650 Wavelength Fig 2 Average spectral irradiance for wavelengths from 320nm to 550nm After operation hours the lamps lose gradually their output power being recommended to check periodically the radiation power with the appropiate measuring equipment When radiation drops below 4 iW the lamps should be replaced as indicated in chapter MAINTENANCE AND CLEANING MAN 002 NESTOPHOT Jan 08 Ed 2 Rev 1 10 GUIDO RAYOS X S A Lamp Efective area Os S SN heigth mm mm is oe 500 850 x 1000 i oe 800 830 x 900 a 1000 600 x 600 Nestophot Figure 4 3 Radiation area depending on lamp heigth IV INSTALLATION INSTRUCTIONS Inside the crate the following parts are packed separately PHOTOTHERAPY UNIT STAND UPPER AND LOWER BARS MOBILE BASE To assembly above parts proceed as follows Unpack carefully each part Place the large diameter bar into the hole at the mobile base Insert the thiner bar into the large diameter bar IMPORTANT The groove of the thiner bar must be oriented backwards the mobile stand assembly Then secure tightly the allen screw an allen key is enclosed within the equipment to avoid the bar could be rotated or pulled out from the wheeled base Insert the Phototherapy unit into on the mobile stand matching both in order to fasten them by means of the allen screw Screw must be tightly secured See following drawing NESTOPHOT MAN 002 Jan 08 E
3. protect from high light levels Reset the clock to zero when starting the treatment to know the exact time for each patient The total time clock will inform the total time that the Phototherapy is being used In such way the user will know how long the lamps have been operating When the treatment time is over or any time the operator wants to interrupt the treatment press I O to switch off the unit When installed at a mobile stand the shroud height can be adjusted For such purpose hold tightly the stand upper bar and loose by turning counterclockwise the locker placed on top of the stand lower bar Slide upwards or downwards the phototherapy assembly and then turn tightly clockwise the locker Check the stand bar is duly secured The NESTOPHOT shroud can be positioned in vertical if required Turn the shroud to place at the required position a ball and socket joint allows the manoeuvre and adjust the height as explained here above NESTOPHOT MAN 002 Jan 08 Ed 2 Rev 1 GUIDO RAYOS X S A III LAMPS NESTOPHOT comprises four DULUX L lamps specially designed for this kind of treatment The lamps emit at 8 iIW cm nm measured at 80 cm distance For an effective treatment 4 1W cm nm are required at least iW em nm 200 150 100 50 Distance cm Fig 1 Total irradiance for bilirrubin and its dependency with the distance Relative radiation intensity 350 400 450 500 550 600 nm
4. with glucuronic acid and thus be separated through the bile If an icterus occurs on the first day of the newborn infant treatment to reduce the bilirubin is nec essary The phototherapy method has predominated as a reliable method Through a photo chemical reaction light changes insoluble bilirubin into the water soluble form permitting removal through the bile and urine without coupling to the glucuronic acids in the liver For an effective treatment at least 4 IW cm nm of radiant flux is required NOTE bilirubin photoisomer can cause detrimental effect in the patient NESTOPHOT phototherapy unit emits 8 IW cm nm exactly 460 nm range to reduce the treat ment duration and consequently increase lamps life This turns it to an extremely suitable instru ment for bilirubin treatment NOTE NESTOPHOT uses cold light lamps so its use do not increase patient tem perature NESTOPHOT equipment is provided with an electric clock for total operation time and an electric clock for treatment time with zero reset NESTOPHOT has four castors to its better mobility NOTE this equipment can be used in combination with a thermotherapy device with out affecting the temperature of the patient So the use of skin temperature sensor is not indispensable MAN 002 NESTOPHOT Jan 08 Ed 2 Rev 1 8 GUIDO RAYOS X S A II OPERATION To turn on the Phototherapy Unit just press the I O switch WARNING Cover infant s eyes to
5. GUIDO RAYOS X S A TABLE OF CONTENTS PAG Disclaimer 3 Symbols chart 4 Specifications 5 Warnings 6 I Preliminary 7 Intended use 7 II Operation 8 Lamps 9 IV Installation instructions 10 V Maintenance and cleaning 12 Electric wiring 13 Spare parts list 14 Warranty 16 Certifications 16 manco NESTOPHOT Ed 2 Rev 1 2 GUIDO RAYOS X S A NESTOPHOT MAN 002 Jan 08 Ed 2 Rev 1 GUIDO RAYOS X S A 3 DISCLAIMER The safety devices and other controls provided in this eguipment will perform reliably when operated maintained and repaired in accordance with the instructions of this manual Safety devices must be checked periodically and reset repaired or replaced as necessary to ensure that they will operate reliably Eguipment and parts that are broken missing badly worn distorted or contaminated should be replaced with appropriate GUIDO RAYOS X parts The equipment or its components should not be modified without the approval of the manufacturer The Manufacturer disclaims all responsability for any malfunction of this equipment resulting from faulty operation maintenance or repair or if any of its components are damaged or modified by anyone other than the manufacturer MAN 002 NESTOPHOT Jan 08 Ed 2 Rev 1 GUIDO RAYOS X S A SYMBOLS CHART DESCRIPTION In compliance with the reguirement of the Medical Devices Directive 93 42 EEC Certified by notified body no 0120 Alterning cu
6. STEM NESTOPHOT a aa NESTOPHOT MAN 002 Jan 08 Ed 2 Rev 1 GUIDO RAYOS X S A COMPONENT GUANTITY Slow fuse 2 A 2 NESTOPHOT transparent plastic Starter holder Fuse holder 5x30 Tube holder Reactance 15 20 W 230 V Digital clock Castor M10 with brake Castor without brake Tube holder shell right Tube holder shell left Upper shell Nestophot rack cover Tube cover 40x40 Tube 40x36mm 1 meter Nesto shell Nutser screw M3 Nutser screw M8 No By ay ms sf ms FDO BOO PO AJ MAN 002 Jan 08 Ed 2 Rev 1 NESTOPHOT 16 GUIDO RAYOS X S A NESTOPHOT MAN 002 Jan 08 Ed 2 Rev 1 GUIDO RAYOS X S A WARRANTY GUIDO RAYOS X S A hereinafter referred to as GRX warrants that each NESTOPHOT will be free from defects in material and workmanship under normal use and service for a period of one year from the date of delivery by GRX to the first purchaser If any such defect occurs during the warranty period the aforesaid purchaser should communicate directly with GRX agent If returned GRX s agent will arrange for repairs or replacement within the terms of warranty The defective instrument should be returned properly packed freight prepaid Loss or damage in shipment to GRX agent shall be at purchaser s risk This same warranty is made for a peri
7. d 2 Rev 1 GUIDO RAYOS X S A 11 ASSEMBLY SHROUD FIXING ALLEN SCREW SM SM s SHROUD TURNING LOCK HEIGHT REGULATION LOCK N TO THE MAINS MAN 002 Jan 08 Ed 2 Rev 1 12 GUIDO RAYOS X S A V MAINTENANCE AND CLEANING Guido Rayos X S A will provide under reguest any schemes of the circuits listings of com ponents descriptions instructions of calibration and other information that help suitably tech nical personnel to repair those parts of NESTOPHOT equipment designated by the manufac turer as repairable ATTENTION the fluorescence lamps must be collected according the current legislation Lamps substitution ATTENTION The substitution of the lamps must be made only by authorized qualified personnel To replace the lamps proceed as follows Unplug the power cord from the mains Switch must be on O position Loose the screws placed on the top of the shroud Remove carefully the shroud top Loose and remove upwards the lamps rack Remove carefully the lamps holding them tightly Install and secure the new lamps into their fittings Place the lamps rack into the shroud oOo N OOF Na Replace the shroud top 9 Screw the shroud top 10 Plug the power cord 11 Turn on the unit to test its performance ATTENTION the use of lamps others than recommended DULUX L lamps can affect both the security and the effectivenes
8. nominacion PHOTOTERAPY DIAGRAM 125 230V 50 60HZ y 0242 4 Sustituido por MAN 002 NESTOPHOT Jan 08 Ed 2 Rev 1 14 GUIDO RAYOS X S A SPARE PARTS LIST COMPONENT GUANTITY WASHER DIN 125 NYLON 3 5 MM 6 WASHER DIN 127 M5 GROWER 4 FLEX CORD 1 MM BLUE 2M FLEX CORD 1 MM BLACK 2M FLEX CORD 1 MM GREEN 1M GROUND CORD GREEN YELLOW 1MM 15M CONNECTOR 6 PIN FEMALE 1 CONNECTOR 6 PIN MALE 1 PLASTIC CLAMP BIG 10 PLASTIC CLAMP SMALL 25 BLACK SWITCH ON 1 LAMP DULUX L 18 71 PHOTOTHERAPY 5 CONNECTIONS STRIP FASTON TERMINAL FEMALE 6 3 MM WITH HOLD FASTON TERMINAL MALE 6 3 MM WITH HOLD FEMALE TERMINAL BLUE BF F608 P OPEN TERMINAL BLUE BF U4 ROUND TERMINAL BLUE BK M4 ROUND TERMINAL RED RF M3 OPEN TERMINAL RED RF U4 SCREW DIN 913 M6X16 FIXED SCREW DIN 916 M6X8 SCREW DIN 965 M3X20 SCREW DIN 7985 M3X8 SCREW DIN 7985 M4X6 SCREW DIN 7985 M4X8 SCREW DIN 7985 M4X10 SCREW DIN 7985 M5X10 SCREW DIN 7985 M5X20 SCREW DIN 7985 M6X10 THERMICAL RETRACTILE TUBE 2MM NUT DIN 934 M3 NUTSER NUT M4 NAAA et ROO A para o gt amp la NIO WASHER DIN 6799 M3 ALUMINUM ROD WITH CHANNEL 80 CM NESTOPHOT BASE SUBJECTION RACK CABLE WITH POWER BOLT 3M 3X15 1 INFERIOR ENVELOPE CARCASS SUPERIOR ENVELOPE CARCASS SOCKET 25X35 STARTER 15 20 W TUBE CLIP PROFILE REGULATION SY
9. od of thirty days with respect to the expandable parts In no event shall GRX be liable for any incidental indirect or consequential damages in connection with the purchase or use of the unit This warranty shall not apply and GRX shall not be responsible for any loss arising in connection with the purchase or use of any unit wich has been altered by anyone other than an authorized GRX representative or altered in any way that in GRX s judgement affects its stability or reliability or wich has been subject to misuse negligence or accident or wich has been used otherwise than in accordance with the instructions furnished by GRX This warranty is in lieu of all other warranties express or implied and of all other obligations or liabilities on GRX s part and GRX neither assumes or authorizes any representative or other person to assume for it any other liability in connection with the sale of such unit GRX disclaims all other warranties express or implied including any implied warranty of merchant ability or of fitness for a particular purpose or application other than those expressly set forth in the appropiate product labelling or user information manual CERTIFICATIONS The quality system of GUIDO RAYOS X S A has been audited and certified by SGS United Kingdom Ltd for its compliance with the requirements of standards ISO 9001 2000 and ISO 13485 2003 MAN 002 NESTOPHOT Jan 08 Ed 2 Rev 1 Manufacturer GUIDO RAYOS X
10. rrent Atention read the attached documents Class I Type B Eguipment Electrical waste Selective collection NESTOPHOT MAN 002 Jan 08 Ed 2 Rev 1 GUIDO RAYOS X S A 5 SPECIFICATIONS Description Phototherapy Model NESTOPHOT Power External AC 230 V 50 60 Hz 1 5 A 100W Electric isulation Class Incoming water protection Ordinary IPXO Operation mode Continuos Fuses 2 slow fuses 2 A 5x20 mm Measurement Mounting height 1 40 m foot 59x47 y 27x47 Lamp unit 60x30 cm Wavelenght range 460 nm blue specter Thermal power 4 lamps 18 w each Radiation 8 3 IW cm nm at 80 cm from light source 19 7 1W cm nm at 50 cm from light source Storage and handling Temperature 10 C to 40 C conditions Humidity 10 to 90 Noise level Less than 40 dBa MAN 002 NESTOPHOT Jan 08 Ed 2 Rev 1 GUIDO RAYOS X S A WARNINGS Generals It has not been detected anomalies in the operation of the equipment by the effect of external electromagnetic interferences such as mobile phones laptops etc It has not been detected any alteration in the operation of the equipment by variation of the environmental conditions It has not been detected injurious effects of the equipment on the patient nor on the operator Despite of it the use of protective goggles or screens is recommended It has not been detected any perturbation in the water balance of the patient by effect of the lamps of cold light Moni
11. s of the equipment Cleaning For routine cleaning the entire unit may be wiped with a mild soap and water solution Avoid scratching painted surfaces Do not use any cleaning agent containing an abrasive material When sterilization of exterior parts is necessary wipe those parts with a cold sterilization agent not including alcohols or ethers NESTOPHOT MAN 002 Jan 08 Ed 2 Rev 1 GUIDO RAYOS X S A 13 ELECTRIC DIAGRAM F1 2A o 2 24 ON OFF 230V 50 60HZ 1 4A 1 1 1 1 O 2 N1 2 CON1 2 5 N1 3 27 1 gt Si CON1 4 l 1 5 ojo Li TREATMENT 2 Za Z m Se 0 CLOCK lt lt lt lt Ez 2 Ez Ez Q Q z TOTAL CLOCK O E W Y 5 a CON1 NN NN NN GUIDO Fecha Nombre Material Referencia Tolerancias RAYOS X Dibujado 17 3 2004 J Ruiz S A Comprobado Madrid Autorizado N Plano 0242 5 Escala Sustituye a De
12. tor bilirrubin values according to the indications of the medical facultative Do not use NESTOPHOT equipment in combination with flammable products such as cleaning or antiseptic agents Do not store medicaments nor infusion liquids into radiation area Do not use NESTOPHOT equipment in the presence of gases that can help the com bustion Do not use two or more phototherapy units together nor adjacent Carry the equipment holding the vertical bar Do not push the frontal nor the back of the lamps module to transport In chapters Bilirubin photoisomer can cause detrimental effect in the patient NESTOPHOT uses cold light lamps so its use do not increase patient temperature This equipment can be used in combination with a thermotherapy device without af fecting the temperature of the patient So the use of skin temperature sensor is not indispensable Cover infant s eyes to protect from high light levels V The fluorescence lamps must be collected according the current legislation The substitution of the lamps must be made only by authorized qualified personnel The use of lamps others than recommended DULUX L lamps can affect both the security and the effectiveness of the equipment NESTOPHOT MAN 002 Jan 08 Ed 2 Rev 1 GUIDO RAYOS X S A 7 I PRELIMINARY Intended use Bilirrubin is produced primarily in the decomposition of red blood cells it becomes water solubles in the liver through combination
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