Nidek Nuvo Lite Mark 5 Oxygen Concentrator Service Manual
Contents
1. USER S GUIDE Mark 5 Nuvo Sid LITE OXYGEN CONCENTRATOR Original language is English Federal Law US restricts this device to sale or use by or on the order of a licensed hysician This oxygen concentrator should ARNINGI POY yg i i be used only under the supervision of a Sa Danger Do not smoke when using oxygen or when near this device licensed physician CONTENTS GLOSSARY OF SYMBOL G c ssssssssssssssssssssssesoneeneess 1 IV USEFUL INFORMATION scssessesssssseesneeseeenes 4 GENERAL SAFETY GUIDELINES 2 TVI Accessories and spare PpATtS e ne 4 L DESCRIPTION ccssssssssscccccsssseesecccsssnsseecceeeensees 2 IV2 Materials in direct or indirect contact with patient 4 IV 3 Operating principles 4 L1 Front panel Fig I 1 3 V4 Alarms Safety devices 5 Lae Rear panel Bien Ee aata 2 IV 5 Indicator light function 5 II STARTING UP INSTALLATION ieeeeeee 3 IV 6 Technical characteristics smemmeeeeeeeneeee 5 vege VY Standards sr e E ae ge seer sd SE ve 6 1 her py jine rei DENE OM SE Mo IV 8 Method for disposing of waste 6 HI CLEANING MAINTENANCE ccccccccocccocceccscecceee 4 IV 9 Method for disposing of device 6 IV 10 Troubleshooting ennenne 7 TH 1 Cle2. If the replacement parts used for the periodic servicing by an approved technician do not comply with the manufacturer s specifications the manufacturer is not responsible in the event of an accident This device complies with the requirements of the FDA Qua lity System Regulation but its operation may be affected by other devices being used near by such as diathermy and high frequency electro surgical equipment defibrillators short wave therapy equipment mobile telephones CB and other portable devices microwave ovens television induction plates or even remote control toys or any other electromagnetic interferen ces which exceed the levels specified by the EN 60601 1 2 standard See Pgs 8 amp 9 I DESCRIPTION The MARK 5 Nuvo LITE is intended to supply supplemental oxygen to persons requiring low flow oxygen therapy It is not intended to be life supporting or life sustaining It produces an oxygen enriched product by concentrating the oxygen contained in room air by removing most of the nitrogen It can be used either to administer oxygen with nasal cannulas or another probe or mask type of device The MARK 5 Nuvo LITE is easy to use The single flow adjustment knob allows ethe device to be easily adjusted to the prescribed flow rate the equipment supplier or medical staff to limit flows to a specific flow rate with a built in locking device It has a power failure alarm and an operating fault alarm Note the perfo
3. e Relative humidity of between 15 and 95 operation and less than 95 storage both non condensing e Altitude 21 C Up to 2 286 m 7 500 ft without de gradation Consult your eguipment provider for further information regarding 2 286 m to 4000 m 7 500 to 13000 ft e Complies with EN60601 1 standard spilling of a glass of water IV 7 Standards EN 60601 1 UL60601 1 2003 CAN CSA C22 2 No 601 1 M90 w A1 amp A2 Electrical Safety Medical Devices EN60601 1 2 2001 Electromagnetic Compatibility IV 8 Method for disposing of waste All waste from the MARK 5 Nuvo LITE patient circuit filter etc must be disposed ofusing the methods appropriate to the civil authority of the location where disposed IV 9 Method for disposing of the device In order to preserve the environment the concentrator must only be disposed of using the appropriate methods All materials of construction are recyclable MARK 5 Nuvo LITE Serial No Date first used Maintained by Your eguipment supplier Address Telephone PREVENTIVE MAINTENANCE a Wash cabinet filter weekly b Inspect inlet air filter at each patient visit Replace filter every 2 years or more often depending on environment c Check oxygen concentration every 5 000 hours or 1 year The manufacturer s instructions for the preventive maintenance of the devices are defined in the maintenance manual Check with your service provider for any updates t
4. that it is ready to provide oxygen enriched air to the patient To be lighted it is ne cessary that the concentrator power plug be inserted into the wall outlet and that the ON OFF 1 0 switch be actuated IV 5 2 Red Indicator The red LED indicator light is utilized to warn the patient of a system fault The two events that can cause the red LED indicator to be lighted are abnormal system pressure and loss of mains power The abnormal system pressure warning red LED will light and an audible alarm will sound when product pressure is outside of normal opera ting range The audible alarm will sound intermittently on loss of mains power The red LED will also illuminate on some models Call the equipment supplier to service the device IV 5 3 Maintenance of the system alarms e No special maintenance is required The equipment supplier checks that the unit is still operating correctly when the routine checks are performed on the MARK 5 Nuvo LITE IV 6 Technical characteristics Dimensions L x W x H 36x23x58 5cm 14 x 9 x 23 in Caster diameter 5 0 cm 2 0 in Tilt angle transport with humidifier fitted 30 Weight 13 kg 30 Ibs depends on model Noise level 45 to lt 40 dBA depends on model Flow values 12 postion adjustable flow valve 0 125 5 liters minute Some models may have other values Accuracy of flow supplied The flow supplied is equal to the flow set on the flowmeter accurate to w
5. the electromagnetic environment specified below The userofthe MARK 5 Nuvo LITE should assure thatitis used in such an environment Emission tests Compliance Electromagnetic environment guidance RF emissions Group 1 The MARK 5 Nuvo LITE 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 eguipment RF emissions Class B The MARK 5 Nuvo LITE is suitable for use in all establishments CISPR 11 including domestic establishments and those directly connected to the Harmonic emissions IEC 61000 3 2 Voltage fiuctuations Flicker emissions IEC 61000 3 3 Class A public low voltage power supply network that supplies buildings used or domestic purposes Guidance and manufacturer s declaration electromagnetic immunity The Mark 5 Nuvo Lite is intended for use in the electromagnetic environment specified below The user of the Mark 5 Nuvo Lite should make sure that it is used in such an environment Immunity Test IEC 60601 Test Levels Compliance Level Electromagnetic Environment Guidance Electrostatic Discharge ESD Floors should be wood concrete or ceramic IEC 61000 4 2 i i tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical Fast Transient Burst ft2kV for power supply lines 2kV for power supply lines Mains power quality should be that
6. aning v1 32 essed NE AE Ri avbe APPENDIX A EMC INFORMATION 8 9 111 2 Everyday disinfection k IIL 3 Maintenance ON power switched on Do not use oil or grease Off power switched off k Type B device ZA o Class II protection Keep in the vertical position ta Do not expose to open flames Technical information Consult the accompanying documents Fragile handle with care 2010 8400 Rev F May 2011 1 GENERAL SAFETY GUIDELINES Only persons who have read and understood this entire manual should be allowed to operate the MARK 5 Nuvo LITE USE OF OXYGEN Oxygen is not a flammable gas but it accelerates the combustion of materials To avoid all risks of fire the MARK 5 Nuvo LITE should be kept away from all flames incandescent sources and sources of heat cigarettes as well as any combustible products such as oil grease solvents aerosols etc gt 2 z o Do not use in an explosive atmosphere Avoid letting oxygen accumulate on an upholstered seat or other fabrics If the concentrator is operating wanmne While not supplying oxygen to a patient position it so that the gas flow is diluted in the surrounding air Place the device in a ventilated area free from smoke and atmospheric pollution be sure the cabinet s air filter is not obstructed The MARK 5 Nuvo LITE must only be used for oxygen therapy and only on medical prescripti
7. distance Conducted RF 3 Vrms d 1 2vP IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m d 1 2vP 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz d 2 3 vP 800 MHz to 2 5 GHz w here P is the maximum output power rating of the trans mitter in w atts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths fromfixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each freguency range b interference may occur in the vicinity of eguipment Ko marked with the follow ing 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 electro magnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the MARK 5 Nuvo LITE is used exceeds the applicable RF compliance level above the MARK 5 Nuvo LITE should be observed to verify normal operation lf abnormal performance is observed additional measures ma
8. ed indicator will light and the audible alarm will sound for a few seconds until system pressure rises to the accepted level g Turn the flow adjustment knob 4 to the prescribed value This knob may have already been locked in the medically prescribed position In this case do not force it Only the technician or medical personnel are authorized to release it h Check that the oxygen flows out of the administration device nasal cannulas or other by placing the orifice s on the surface of a glass of water The flow should disturb the surface of the water i Adjust the nasal cannula to suit your face Note the required oxygen concentration is normally obtained within five minutes after the unit is started At the end of the treatment press the I O switch to place it in the O OFF position to stop the device The oxygen enriched air flow continues for approximately minute after the device is stopped For the equipment supplier or medical staff The flow adjustment knob may be locked to limit it to a specific predetermined value 2010 8400 Rev F May 2011 3 III CLEANING MAINTENANCE II 1 Cleaning Only the outside of the MARK 5 Nuvo LITE is tobe cleaned with a soft dry cloth or if necessary a damp sponge then thoroughly dried with wipes and an alcohol based solution Acetone solvents or any other inflammable products must not be used Do not use abrasive powders The removable Cabinet Air dust filt
9. er 2 must be cleaned weekly in warm water and household detergent or after approximately 100 hours of use More frequentcleaning is re commended in dusty enviroments Dry before reinstalling E 1 Filter S um Silencer 2 Cabinet Air dust filter 3 Ventilation grill II 2 Daily disinfection Due to the presence of the final product filter lt 0 3 um inside the device everyday disinfection concerns only the external oxygen therapy accessories humidifier probes nasal can nulas refer to the respective instructions for use The device must be switched off when alcohol based solutions are used a The following minimum guidelines should be observed Humidifier If prescribed by a physician Clean according to the manufacturer s instructions If no instructions are provided do the following Daily Empty the water from the humidifier Rinse the humidifier flask under running water Fill humidifier up to the mark with distilled water Regularly Disinfect the humidifier parts by immersing them in a disinfectant solution in general we recommend using a solution of 1 part vinegar diluted with 10 parts water Rinse and dry Check that the humidifier lid seal is in good condition e Oxygen tubing and nasal cannula Follow the manufacturer s instructions b For each new patient Follow the instructions from the humidifier manufacturer The MARK 5 Nuvo LITE cabinet should be cleaned and d
10. er located prior to the oxygen outlet fitting IV 4 Alarms Safety Devices IV 4 1 Alarm No voltage detection In the event cf gt loss of mains power an intermittent audible alarm is activated Test alarm by activating the I O On Off switch with power cable unplugged from wall outlet e Power Quality A rapidly pulsing alarm is indicative of a power quality problem that normally will not affect the machines output if the problem persists contact your power provider e Process fault In the case of a process fault a visible and audible alarm is activated continuous red light and audible alarm see p 7 e No Oxygen Flow Alarm If supplied with unit The Nuvo Lite Concentrator has a no flow alarm option This device provides a continuous audible alarm in the event the oxygen flow to the patient becomes blocked IV 4 2 Safety devices e Compressor motor Thermal safety is ensured by a thermal switch situated in the motor winding 145 5 C e Electrical Protection A SA circuit breaker is incorporated into the front cabinet of all 230V models A 10 A circuit breaker is included with 115V models Class II device with insulated casings EN60601 1 stan dard e Pressure A safety relief valve calibrated to 2 7 bar 40 psig is fitted on the compressor outlet IV 5 Indicator Light Function IV 5 1 Green Indicator The green LED indicator light indicates that power is applied to the concentrator and
11. ilter Part Ref 8400 1025 Humidifier Tubing Part Ref 8400 8409 Inlet Air Filter Part Ref 8400 1180 Wash weekly Replace as needed Wash in warm water Replace as needed Inspect at each patient visit Replace every 2 years Please record all maintenance activity on the Maintenance Log found in the Service Manual and online at www nidekmedical com under the Maintenance Log tab 2010 8400 Rev F May 2011 APPENDIX A EMC Information Important Failure to follow these guidelines listed may result in increased emissions and or decreased immunity of the Mark 5 Nuvo Lite concentrator Medical Electrical Eguipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual Portable and mobile RF communications eguipment can affect Medical Electrical Eguipment The use of Accessories transducers and cables other than those specified by the manufacturer may result in increased Emissions or decreased Immunity of the Mark 5 Nuvo Lite The Mark 5 Nuvo Lite should not be used adjacent to or stacked with other eguipment and that if adjacent or stacked use is necessary the Mark 5 Nuvo Lite should be observed to verify normal operation in the configuration in which it will be used Use only Nidek replacement electrical parts Guidance and Manufacturer s Declaration Electromagnetic Emissions The MARK 5 Nuvo LITE is intended for use in
12. isinfected as per the above instructions The cabinet air filter should be washed or replaced The entire oxygen ad ministration circuit oxygen therapy nasal cannulas etc must be changed ILI 3 Maintenance No special maintenance needs to be carried out by the patient Your equipment supplier performs periodic main tenance operations to assure continued reliable service from the MARK 5 Nuvo LITE IV USEFUL INFORMATION IV 1 Accessories and spare parts The accessories used with the MARK 5 Nuvo LITE must e be oxygen compatible e be biocompatible e comply with the general requirements of the FDA Quality System Regulation The connectors tubes and nasal cannulas must be designed and approved for oxygen therapy usage The accessories with a Nidek Medical part number reference or included in the set of accessories supplied with the device comply with these requirements Contact your equipment provider to obtain these accesso ries Note The use of certain administration accessories which are not specified for use with this concentrator may reduce its performance and void the manufacturer s responsibility AVAILABLE ACCESSORIES IF PRESCRIBED BY A PHYSICIAN Humidifier Cannula with 2 m 7 ft tubing Extension Tubing 7 7 m 25ft Tubing Adapter P N 9012 8774 P N 9012 8780 P N 9012 8781 P N 9012 8783 The above items are available from Nidek Medical Products Inc IV 2 Materials in direct or indirect c
13. ithin 10 or 200 ml min whichever is the larger of the two Oxygen Concentration e at 2 l min gt 90 e at 5 l min 90 6 5 3 Values at 21 C and at one atmosphere pressure Max recommended flow 5 l min The variation of the maximum recommended flow does not exceed 10 of the indicated value when a back pressure of 7 kPa 1 psig is applied to the output of the device The maximum outlet pressure is 50 kPa 7 psig 2010 8400 Rev F May 2011 5 Electrical power supply 115 V Units 230 V Units Freguency 60Hz 50 amp 60Hz Average Power 330 W avg 300 W avg Protection Class Class II Class II Mains Protection 10A SA Eilters At the rear of the device a cabinet air dust filter At the compressor input an inlet air filter 5 um behind the cabinet filter Before the oxygen outlet a final product filter lt 0 3 um technician only Air circulation A tubeaxial fan cools the compressor compartment Environmental limit conditions The performances of the device especially the oxygen concentration are guoted at 21 C 70 F and one atmos phere They may change with temperature and altitude For further information please consult the maintenance manual e The device must be stored transported and used in the vertical position only e Ambient temperature of between 5 C and 40 C 40 F and 104 F operation e Storage temperature range 20 C to 60 C 4 F to140 F
14. kup Capacitor has discharged operate unit for approximately 10 minutes and retest Contact your eguipment supplier Contact your eguipment supplier The I O ON OFF button is ON and the compressor is operating but there is no flow The audible alarm sounds continuously The I O ON OFF button is ON the compressor is operating there is a flow but the audible alarm sounds continuously Pneumatic connection broken or other pressure problem Internal electrical fault Pneumatic circuit fault Stop the device by pressing the I O ON OFF button and contact your eguipment supplier Stop the device and contact your eguipment supplier The compressor stops in mid cycle then starts again after a few minutes Compressor thermal safety device has been activated Fan is not working Dirty Filters Stop the device and wait for it to cool down Clean cabinet filter Start up again Reset the circuit breaker Contact your eguipment supplier If the device does not start contact your eguipment supplier The oxygen enriched product flow is interrupted at the nasal cannula outlet Tube disconnected or humidifier not tight Check that tubing connections are secure and that the tubing is not kinked The flow at the nasal cannula outlet is irregular Cannula tubing is kinked Straighten the tubing contact your eguipment supplier if damaged Gb Maintenance Items Cabinet Air F
15. lectromagnetic propagation is affected by absorption and reflection from structures objects and people 2010 8400 Rev F Jan 2011 9 10 May 2011 2010 8400 Rev F 2010 8400 Rev F May 2011 1 12 Nidek Medical Products Inc 3949 Valley East Industrial Drive Birmingham Alabama 35217 U S A Tel 205 856 7200 Fax 205 856 0533 info Onidekmedical com www nidekmedical com May 2011 2010 8400 Rev F
16. o the recommended schedules The work must be carried out by suitably trained tech nicians certified by the manufacturer Use original spare parts only see Pg 7 Upon reguest the supplier can provide circuit diagrams spare parts lists technical details or any otherinformation of use to gualified technical personnel for parts of the device which are designated as being the manufacturer s responsibility or by the manufacturer as repairable Medical Device Regulations reguire users and service providers to report to the manufacturer any incident that could if repeated result in injury to any person 6 May 2011 2010 8400 Rev F IV 10 Troubleshooting Observations The I O ON OFF button is in the ON position but the device does not operate The intermittent alarm sounds Possible Causes Power cable is not correctly plugged in Power failure Solutions Check the cable connection Check the circuit breaker on the front of the unit under the flowme ter Red light remains lighted A rapidly pulsing alarm The alarm test does not work See IV 4 1 The compressor operates and the I O ON OFF button is in the ON position but the green light is not lighted Product pressure is too low or too high Power Ouality Capacitor is not charged Internal electrical fault Faulty indicator Contact your eguipment supplier If the problem persist contact your power provider Bac
17. of a Surge 2kV for power supply lines 2kV for power supply lines Mains power quality should be that of a Voltage dips short lt 5 Ur lt 5 U7 Mains power quality should be that of a interruptions and voltage typical commercial or hospital environment variations on power supply 40 Ur 40 Ur If the user of the Mark 5 Nuvo Lite requires input lines continued operation during power mains IEC 61000 4 11 70 U 70 U interruptions t is recommended that the Mark 5 Nuvo Lite be powered from an lt 5 U lt 5 U uninterruptible power supply or a battery Power freguency 50 60 Hz 3 A m 3 A m Power freguency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE U is the a c mains voltage prior to application of the test level 8 Jan 2011 2010 8400 Rev F Guidance and manufacturer s declaration electromagnetic immunity This MARK 5 Nuvo LITE is intended for use in the electromagnetic environment specified below The user ofthis MARK 5 Nuvo LITE should make sure itis used in such an environment Immunity Test IEC 60601 Test Levels Compliance Level Electromagnetic Environment Guidance Portable and mobile RF communications eguipment should be used no closer to any part of the Mark 5 Nuvo Lite including cables than the recommended separation distance calculated from the eguation applicable to the freguency of the transmitter Recommended separation
18. on The indicated daily duration and flow must be followed otherwise it may present a risk to the health of the patient DID Be Do not use in a specifically magnetic environment such as MRI X ray etc gt USE AND MAINTENANCE OF DEVICE Do not open the device while in operation risk of electrical shock Use the power cord provided and check that the electrical characteristics of the power socket used match those indicated on the manufacturer s plate on the rear panel of the machine CAUTION We recommend against the use of extension cords or adapters as they are potential sources of sparks auron and fire The MARK 5 Nuvo LITE has an audible alarm to warn the user of problems In order that the alarm may be heard the maximum distance that the user can move away from it must be determined to suit the surrounding noise level CAUTION DDD PIP CONFORMITY WITH IEC60601 1 6 8 2 B The manufacturer assembler installer or distributor are not considered to be responsible themselves for the consequences on the safety reliability and characteristics of a device unless e The assembly fitting extensions adjustments modifications or repairs have been performed by persons authorized by the party in question e The electrical installation of the corresponding premises complies with local electrical codes e g IEC NEC e The device is used in accordance with the instructions for use
19. ontact with the patient Concentrator casing ABS Polycarbonate Mains Cable senise oeiee ar eden ete PVC Du t fte tati esteetika talt a Polyester ON OFF Switch siste lea uroki Nylon C sters iii aje liki a dd s elu laest bed hede beer died Nylon Flow adjustment knob enne ABS Oxygen Product outlet Metal Alloy Printed labels ra netni Polycarbonate Pipe Tubing Aluminium PVC polyurethane or silicone UMA TOR 4310 5226S eee eko a ukane Polypropylene Humidifier Tubing cc ccccecccecceseceeseesseeseeeseceeeseees PVC Filter vicars anointed dn ket Polypropylene 4 May 2011 2010 8400 Rev F IV 3 Operating Principle The compressor sends filtered room air to a solenoid valve which allows compressed air to pass to the column in pro duction The columns contain a molecular sieve material that functions to adsorb the nitrogen from the room air and thus allow oxygen to pass through The oxygen enriched product is then directed to a pressure reducing valve through the adjustable flow control to the oxygen product outlet fitting During this time the other column being regenerated is connected to the ambient air and a flow of oxygen enriched product is passed through it from the column in produc tion In this way when one column is in production the other is in a nitrogen desorption or regeneration phase The oxygen enriched product finally passes through a final product filt
20. rmances described pertain to the use of the MARK 5 Nuvo LITE with the accessories recommended by Nidek Medical Products Inc May 2011 2010 8400 Rev F I 1 Front panel Fig I 1 1 W O ON OFF Switch 2 Indicator Lights 3 Oxygen product outlet 4 Flow adjustment knob l min 5 Circuit Breaker I 2 Rear panel Fig I 2 6 Humidifier 7 Filter 8 Power Cord 9 Elapsed Time Meter 10 Technical Label 11 Humidifier Tube 12 Humidifier Bottle Velcro Strap 13 Power Cord Retainer II STARTING UP INSTALLATION II 1 Use in direct oxygen therapy a Ensure that the switch 1 is in the O OFF position b Ifused with a humidifier Unscrew the flask and fill it with water up to the line see humidifier instructions Then screw the lid on the humidifier flask until there are no leaks c Connect the oxygen tube to the humidifier outlet nozzle or to the concentrator outlet if a humidifier has not been prescribed The tube between the cannula and the MARK 5 Nuvo LITE should be limited to 60 feet 20 meters long in order to ensure that the oxygen flow rate remains within specification values d Ensure that all of the parts are connected correctly so as to avoid leaks e Plug the power cable into a power outlet of the correct voltage and frequency as defined on the manufacturer s technical label Fig 12 10 f Press the power switch I O to the ON position The r
21. y be necessary such as re orienting or relocationg the MARK 5 Nuvo LITE b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommended separation distances between portable and mobile RF communications equipment and the MARK 5 Nuvo LITE device The MARK 5 Nuvo LITE is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the MARK 5 Nuvo LITE can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the MARK 5 Nuvo LITE as recommended below according to the maximum output power of the communications equipment Rated maximum output Separation distance according to freguency of transmitter power of transmitter M W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2vP d 1 2vP d 2 3vP 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 12 12 23 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 where P is the maximum output power rating ofthe transmitter in watts W according to the transmitter manufacturer Note 1 At80 MHzand 800 MHz the separation distance for the higher freguency range applies Note 2 These guidelines may not applyin all situations E
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