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Mark 5 Nuvo® Lite Oxygen Concentrator Service Manual

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Contents

1. E eRe ETE eco ann svearanca S GRANE RGN METER eee 5 11 2008 CONTROL a 1 SUFOK PRESSURE ar VALVE L REGULATOR INLET 525 524 ORIFICE BOARD FILTER 522 gog y 12 RHEE HEAT t EXCHANGER i i 5 5 X R H PRODUCT D FILTER i U U E i RELIEF 5 VALVE B T T B D CHECK A VALVE 1 1 N 2 COMPRESSOR 2 FLOW CONTROL OUTLET 6 VALVE MODULAR BED YO ASSEMBLY PNEUMATIC DIAGRAM MARK 5 NUVO LITE OCSI MODEL ROU WE PROPERTY CF NOEK MEDICAL ANG ARE TO wey REV ERASE TET EEF ERE aE BRET TEE CAD FILE 500005 B FLOW DIAGRAM MERES IESE AIRE CONTROL VALVE 1 PRESSURE N MAVEN L REGULATOR INLET ORIFICE 1 4 FILTER PRESSURE NT SENSOR HEAT m EXCHANGER 5 E P 5 1 x R 1 H O E N PRODUCT Vv A D FILTER i E U U E
2. 1 Set the 1 0 ON OFF switch to the 0 OFF position and unplug the power cord Remove the back cabinet Disconnect the 7 pin connector from the circuit board Disconnect tubing from pressure sensor by cutting tie wrap Remove the circuit board and replace with a new one Test the alarm system as described in Section 2 3 Reinstall the back cabinet 5 10 Circuit Breaker Replacement 5 10 1 Circuit Breaker Removal 1 2 3 4 Set the 1 0 ON OFF switch to the 0 OFF position and unplug the power cord Remove the cabinet back Disconnect the circuit breaker leads Unscrew the circuit breaker while you apply pressure to the circuit breaker retaining ring 5 10 2 Circuit Breaker Installation Follow the removal procedure for the circuit breaker in reverse order to install the new circuit breaker 2010 8405 Rev C Page 20 of 42 5 11 5 11 1 1 1 0 ON OFF Power Switch Replacement 1 0 ON OFF Power Switch Removal Set the 1 0 ON OFF switch to the 0 OFF position and unplug the power cord Remove both the back cabinet Disconnect the 1 0 ON OFF switch leads from the back of the switch being careful to note the position of each Push on the back of the power switch while holding in its four retaining tabs and remove the switch through the front of the control panel 5 11 2 1 0 ON OFF Power Switch Installation Follow the removal procedure for the 1 0 ON OFF power switch in
3. 2 Remove the cooling air filter to locate the intake filter 3 Remove filter from the unit and replace with a new filter 4 Record information about the filter replacement on the History Record Card as recommended in Section 4 1 5 9 Reinstall the cooling air filter 4 1 4 Recording Maintenance As the Home Service Provider it is suggested that you record all routine maintenance and repairs performed on the MARK 5 NUVO Lite unit including hours and dates of service 42 Cleaning Unit Periodically use a damp cloth to wipe down the exterior case of the MARK 5 NUVO Lite If you use medical disinfectants be sure to follow manufacture s instructions 4 2 1 Preparing for New Patient Use When you remove the MARK 5 Lite from a patient s home always dispose of the used nasal cannula and humidifier bottle Replace the cabinet dust filter between each patient s use or clean with warm soapy water if it is in good condition Clean this filter at least once per week or more frequently if operated in a dusty environment Change the bacteria filter every 2 years or 15 000 hours of use under adverse conditions filter may need to be changed more frequently if dingy or dirty It is recommended to change the bacteria filter between patients Retest the MARK 5 NUVO Lite before you return it to your inventory 2010 8405 Rev C Page 13 of 42 5 0 Service 5 1 Components The design of the Nidek MARK 5 NUVO Lite Oxygen C
4. Compressor does power to unit Check wall outlet for power Pulsing audible alarm with j Unit circuit breaker tripped Reset or replace circuit 1 0 ON OFF power switch faulty breaker in ON position Faulty electrical Check electrical connections Defective connections circuit board Defective 1 0 ON OFF Check power switch power switch Replace 1 0 ON OFF power switch Compressor runs with Defective high or low Replace and retest pressure intermittent alarm pressure switch switch Concentration at 5 L MIN is Kinked tubing Check tubing that joins the within specifications tops of the sieve beds Compressor shuts down Restricted air flow through Clean inlet filter or remove intermittently unit obstruction Unit overheating due to Locate unit away from improper location heating source providing adequate ventilation on all sides Defective cabinet fan Replace cabinet fan Compressor does not start Extreme cold start Allow unit to reach room 0 ON OFF power switch temperature in ON position intermittent alarm and cabinet fan turns thermally cut Blocked air intake or off due to excessive heat defective cabinet fan clear NOTE It will not restart unit obstruction or replace it cools down cabinet fan Defective capacitor Replace capacitor Faulty electrical connection Check electrical connections for compressor for compressor Compressor
5. Replace compressor Replace flow valve Check tubing that connects the top of the sieve beds Page 29 of 42 Probable Cause Solution Cabinet fan does not turn Limited or low flow Low concentration 2010 8405 Rev C Defective cabinet fan Defective electrical connections Restriction in humidifier or tubing Product regulator set too low Leak Weak compressor Air flow obstruction Compressor inlet filter is dirty or partially blocked System leak Faulty compressor Unit temperature too high Contaminated sieve beds Defective control valve Restriction in exhaust muffler Restriction in suction resonator Replace cabinet fan Check electrical connections Replace humidifier or tubing Adjust regulator setting Leak test and repair leak Check system pressure and rebuild or exchange compressor Check Filter suction resonator and suction tube for obstruction Replace inlet filter Leak test and repair leak Check system pressure and rebuild or replace compressor Blocked air intake or defective cabinet filter Check that P1 and P2 pressures are within range Replace sieve module Repair or replace sieve module Replace or clean exhaust muffler Check suction resonator and suction tube for obstruction and remove Page 30 of 42 6 5 Tool Kit Oxygen Purity testing and Pressure Test Gauge The tools needed for you to properly service the MA
6. the freight company and Nidek Medical Products Inc immediately Check the operation of each MARK 5 NUVO Lite before delivery to patient Always operate the unit for a reasonable length of time and check that the oxygen concentration level is within specifications as referred to in Section 2 4 Test the power failure alarm as described in Section 2 3 of this manual Deliver MARK 5 NUVO Lite units only to patients authorized by a physician s prescription The MARK 5 NUVO Lite must not be used as a life supporting or life sustaining device A backup supply of oxygen must be available Instruct patients how to use the MARK 5 Lite in conjunction with the Users Manual Instruct patients to notify their physicians and or Home Service Providers if they experience any signs of discomfort Instruct each patient how to perform routine maintenance of the cooling air filter and how to check the alarm system Refer to Section3 2 Be available to service each patient at any time Maintain the MARK 5 NUVO Lite in accordance with Section 4 0 2010 8405 Rev C Page 6 of 42 Repair components and replace parts only as outlined in this manual Use only Nidek parts for replacement in MARK 5 NUVO Lite Oxygen Concentrators e Refer to the MARK 5 NUVO Lite Product Warranty if parts replacement is required within the warranty period 1 2 Important Notice and Symbol Explanations As you read the manual pay special attention to t
7. gt HOT BL BR NEUTRAL AUXILIARY CONTACTS SA CIRCUIT BREAKER BL 9 POWER SWITCH HOUR METER 1 2 3 4 5 61 7 Jt PRESSURE ALARM PC BOARD SOLENOID VALVE 1 SOLENOID VALVE 2 COMPRESSOR lt THERMAL DEVICE INSIDE CAPACITOR f COOLING FAN WO GONVHD O 5344 40 40102 dasa a 669 223 223 09 ANSSI WUNI NOLdI49S3q 2010 8405 Rev C A 4 Page 34 of 42 115V ELECTRICAL amp COMPRESSOR ASSEMBLY 2010 8405 Rev C Page 35 of 42 230V ELECTRICAL amp COMPRESSOR ASSEMBLY A 6 2010 8405 Rev C Page 36 of 42 CABINET FRONT ASSEMBLY STD A 7 Page 37 of 42 2010 8405 Rev C FRONT CABINET ASSEMBLY OSCI A 8 2010 8405 Rev C Page 38 of 42 CABINET BACK ASSY STD A 9 Page 39 of 42 2010 8405 Rev C CABINET BACK ASSY OSCI A 10 Page 40 of 42 2010 8405 Rev C MODULE NEW ASSEMBLY 5LPM 2010 8405 Rev C Page 41 of 42 MODULE NEW ASSEMBLY 3LPM 2010 8405 Rev C Page 42 of 42
8. regulator 5 Unplug the solenoid valve electrical leads at the solenoids 6 Lift the module up and out of the cradle 5 5 2 Sieve Bed Installation To install the sieve beds follow the sieve bed removal procedure in reverse order It is very important to tighten ensure that the tubes are fully inserted into the fittings to eliminate leaks To check for leaks take the following steps 1 Plug in the unit 2 Set the unit s 1 0 ON OFF switch to ON for three minutes with the flow meter closed to pressurize the system 3 Apply soapy water around the tubing connections at the valve check for leaks Caution There is an electrical shock hazard with the Power ON Be careful that no water contacts any of the electrical connections NOTE Even small leaks can affect concentrator performance and can cause contamination of the sieve Careful leak testing is important 2010 8405 Rev C Page 17 of 42 5 6 Cabinet Fan Replacement The cabinet fan for the MARK 5 NUVO Lite is located adjacent to the compressor Refer to the troubleshooting chart in Section 6 0 of this manual for instances where replacement of the fan may be required To replace the cabinet fan in the Mark5 Nuvo unit take the following steps 1 Set the unit s 1 0 ON OFF switch to the 0 OFF position and unplug the power cord Remove the back cabinets Disconnect the fan leads Lift out the fan Install isolation foam around new fan Insert into cabin
9. reverse order to install a new power switch 5 12 Buzzer Replacement The buzzer is a fixed component on the circuit board and is not individually replaceable 5 13 1 5 14 5 14 1 1 2 3 4 5 Hour Meter Replacement Set the 1 0 ON OFF switch to the 0 OFF position and unplug the power cord Remove the cabinet back Disconnect the hour meter leads Remove the hour meter from the front cabinet Install the new hour meter into its mounting location Make sure that the hour meter is mounted right side up Reconnect the hour meter leads Reinstall the cabinet back Flow Valve Replacement Flow Valve Removal Set the 1 0 ON OFF switch to the 0 OFF position and unplug the power cord Remove the cabinet back Remove the two hoses from the back of the flow valve Remove the knob from the flow valve and the two Philips screws below the knob Remove the flow valve 2010 8405 Rev C Page 21 of 42 5 14 2 Flow Valve Installation To install a new flow valve follow the flow valve removal procedure in reverse order Then perform a leak test on the connections 5 15 Power Cord Replacement 1 Set the 1 0 ON OFF switch to the 0 OFF position and unplug the power cord 2 Remove the cabinet back Clip the power cord retaining tie wrap Slide the power cord strain relief reinforcement upwards to remove it from the mounting location at the bottom of the front c
10. 1 RELIEF 5 VALVE B T T B D T D CHECK VALVE COMPRESSOR 2 FLOW CONTROL OUTLET VALVE MODULAR BED LS ASSEMBLY IOLERANcES u DIAGRAM MARK 5 NUVO LITE STANDARD MODEL THIS DRAWING AND INFORMATION CONTAINED THEREON ARE ANO REMAIN THE PROPERTY OF MEDICAL AND ARE NOT TO Bi COPED REPRODUCED OR DISCLOSED TO OTHERS WITHOUT THE EXPRESSED WRITTEN CONSENT OF NIDEX MEDI REV DRAWN BY APPRV BY SHEET 1 OF 1 CHEKD BY SCALE DATE 11 14 2007 V FLOW DIAGRAM MARK 5 NUVO TD A 2 2010 8405 Rev C Page 32 of 42 MSVAC 1 1 1 6 4 4 1 a 4 1 1 REV DESCRIPTION BY A MA ISSUE B REVISED HAIER 1 75 Jahaja AUXILIARY CONTACTS 4 pya NIDEK 1 PLACE DECINAL gt DA60 m 145 HO REA C PLACE DECIMAL gt 0020 STK Coe SEES SHEET 1 OF 1 TATE3 10 18 5 4 T T 2 1 CAD FILE 00008 A_ Page 33 of 42 2010 8405 Rev C 3NYN NOILVIOT 1014 OANN S MYYN 20025 19 NMOHE ANTE wovid ALTHM NJS Y9 MOTTAA 230VAC
11. 15 Volt Electrical Schematic 33 A4 230 Volt Electrical Schematic 34 5 115Volt Compressor Assembly 35 6 230Volt Compressor Assembly 36 Front Cabinet Standard Assembly 37 8 Front Cabinet OSCI Assembly 38 9 Back Cabinet Assembly Sandard 39 10 Back Cabinet Assembly OSCI 40 A11 Module Assembly 5 Liter Minute 41 12 Module Assembly 3 Liter Minute 42 General Safety Instructions Production and use of oxygen Oxygen is not a flammable gas but accelerates the combustion of materials To prevent fire risks the MARK 5 NUVO Lite should be kept away from flames incandescent sources or sources of heat cigarettes and combustible products such as oil grease solvents aerosols etc Do not use in an explosive atmosphere Prevent oxygen from accumulating on upholstered seats or any other fabric If the concentrator operates without being administered to a patient locate it so that the flow of gas generated is dissipated into the air Locate the equipment in a free space filter to the rear and below which is well ventilated and free of fumes or atmospheric pollution Use and Maintenance of the Device Use the electric cable provided and check that the voltage of the mains socket used complies with the electrical characteristics of the appliance indicated on the manufacturers plate on the rear of the appliance 2010 8405 Rev C Page 4 of 42 Do not use an extension cord or multiple sockets which can create sparks and t
12. 5 3 Based on 70 F 21 C at sea level Response Time Acceptable concentration is normally achieved in about 90 seconds allow 5 minutes to attain full concentration Positioning Operate the unit in an upright position maintaining at least six inches of open space on all sides for ventilation 2 0 Operational Check and Concentration Test 2 1 Description of Operation Air enters the MARK 5 NUVO Lite Oxygen Concentrator through an external cooling air intake filter This filtered air enters the compressor via a suction tube and fine filter which quiets the suction sounds made by the compressor Pressurized air then exits the compressor and passes through a heat exchanger into a pair of 3 way solenoid valves The heat exchanger reduces the temperature of the compressed air Next the solenoid valve directs the air into one of two sieve beds that contain molecular sieve The special characteristic property of molecular sieve is that it physically attracts adsorbs nitrogen when air passes through this material thus enabling the production of high purity oxygen There are two sieve beds or adsorbent columns while one produces high purity oxygen the other is purged of the nitrogen it adsorbed collected while it was producing oxygen Each column produces oxygen for approximately five seconds and delivers it to the product storage volume tank integrated into the modular bed Oxygen exits the product storage tank through a pressure
13. Nidek Medical Products Inc Mark 5 Nuvo Lite Oxygen Concentrator Service Manual e Nidek Medical Products Inc 3949 Valley East Industrial Drive Birmingham Alabama 35217 USA Telephone 205 856 7200 24 Hour Fax 205 856 0533 Nidek is a registered trademark of Nidek Medical Products Inc Mark 5 Nuvo Lite are registered trademarks of Nidek Medical Products Inc Table of Contents 2 General Safety Instructions Production and Use of Oxygen 4 Use and Maintenance of the Device 4 Standards and Regulations 5 Section 1 0 Introduction 1 1 Home Service Provider Responsibility 6 1 2 Important Notice and Symbol Explanations 7 1 3 Functional Specifications 7 Section 2 0 Operational Check and Concentration Test 2 1 Description of Operation 8 2 2 Operation Check 9 2 3 Alarm System 9 2 3 1 Power Failure Alarm test 10 2 4 Oxygen Concentration Test and Specification 10 Section 3 0 Patient Instructions 3 1 General Instructions 3 2 Routine Maintenance by the Patient 3 2 1 Cleaning the Cooling Air Inlet Filter 11 3 2 2 Checking the Alarm System Battery 12 Section 4 0 Home Service Provider Maintenance 4 1 Routine Maintenance 12 4 1 1 Cooling Air Filter 12 4 1 2 Bacteria Filter Replacement 12 4 1 3 Compressor Filter Replacement 13 4 1 4 Recording Maintenance 13 4 2 Cleaning and Infection Control 13 4 2 1 Preparing for New Patient Use 13 Section 5 0 Service 5 1 Components 14 5 2 Cabinet Removal 14 5 2 1 Removing Cab
14. RK 5 NUVO Lite unit are listed below gt Requires no special tools generally available tools including common pliers channel lock wire cutters needle nose pliers slotted head screwdriver long Phillips head screwdriver 8 inch adjustable wrench 7 16 inch socket 7 16 inch combination wrench 5 8 inch combination wrench and 3 8 inch combination wrench gt For checking the Oxygen purity at the Concentrator Nidek recommends Part 6500 4220 An accurate pressure test gauge to take both P 1 and P 2 pressure readings the MARK 5 Lite unit should be kept available at all times This gauge kit allows connections to the pressure test locations Kit for testing P1 amp P2 pressures with gauge supplied 6500 0051 Kit for testing P1 amp p2 pressures w o gauge supplied 6500 0052 Kit tools for Nuvo Lite 6500 0053 Appendices Drawings Piping for Standard ModeL 1 Piping for OSCI Model A 2 Electrical for 115 Volt Model A 3 Electrical for 230 Volt Model A 4 Electrical amp Compressor Assembly 115 Volt Assembly A 5 230 Volt Assembly A 6 Front Cabinet Assembly Standard Assembly A 7 OSCI Assembly A 8 Back Cabinet Assembly Standard Assembly A 9 OSCI Assembly A 10 Module Assembly 5 Liter Minute Assembly A 11 3 Liter Minute Assembly A 12 2010 8405 Rev C Page 31 of 42 REY DESCRIPTION REF ABP DATE
15. abinet Disconnect the power cord leads from the terminal quick connects Connect the leads on the new power cord at the terminal quick connects Reinstall the power cord strain relief into the base of the unit Reconnect the cabinet back and install a new power cord retaining tie wrap OT A 6 0 Troubleshooting 6 1 Air Pressure Test P1 Testing the operating pressure is a useful diagnostic tool when a concentrator has low purity and requires servicing Units functioning normally do not require operating tests Use the following procedure to test the operating pressure of the unit 1 Set the 1 0 ON OFF switch to the 0 OFF position and unplug the power cord 2 Remove the cabinet rear 3 Remove the air supply tubing going to the control valve and install the test port tee fitting Figure 6 1 1 amp 6 1 2 shows the normal operating configurations for each type of unit Figure 6 1 3 shows the installation of the test ports 4 Connect the pressure test gauge to the test port 5 Plug in the power cord and set the 1 0 ON OFF power switch to the position Set the flow meter to 5 l min and allow the unit to run at least five minutes 6 Observe the maximum and minimum readings on the pressure test gauge 7 The maximum reading should not exceed 34 psig 235 kPa The minimum reading should not be less than 10 psig 70 kPa NOTE When you turn the unit on it will take several minutes to reach normal operating p
16. attach the board to the front cabinet 7 Remove the circuit board NOTE Handle the new circuit board only by the edges to prevent electrostatic damage to the unit For Reinstallation reverse the above procedure 5 7 2 Timing Circuit Board Removal 1 Set the 1 0 ON OFF switch to the 0 OFF position and unplug the power cord 2 Remove the cabinet back 3 Disconnect the 6 and the 4 pin connectors as well as the 6 spade connectors from the Timing Board Brown 220V White 110V wires towards the module side and Blue 220V Black 110V wires toward the compressor side 4 Remove the mounting screws 5 Remove the circuit board NOTE Handle the new circuit board only by the edges to prevent electrostatic damage to the unit For Reinstallation reverse the above procedure 5 8 Product Regulator Check and Setting The product regulator enables you to set the maximum flow of oxygen output by the MARK 5 NUVO Lite unit To check for proper adjustment of the product regulator take the following steps 1 Set the 1 0 ON OFF switch to the ON position 2 Allow the unit to run for a few minutes 3 Connect a pressure gauge directly to the patient outlet 4 The pressure should read 7 2 psig 50 kPa 10 5 If it requires adjustment remove the cabinet back and lift out the module enough to access the regulator 6 Adjust the regulator as necessary Turn the knob clockwise to increase the output pressure Requires a 3 32 he
17. e requirements of the FDA Quality System Regulation and EU Directive 93 42 EEC but its operation may be affected by the use in the surrounding area of appliances such as diathermy high frequency electro surgical instruments defibrillators short wave treatment appliances cell phones CB devices and other portables microwave ovens induction hot plates or remote control toys and more generally by electromagnetic interference exceeding the levels specified in standard IEC EN 60601 1 2 2001 2010 8405 Rev C Page 5 of 42 1 0 Introduction 1 1 Service Provider Responsibility All Home Service Providers of the Nidek MARK 5 NUVO Lite Oxygen Concentrator must assume responsibilities for handling operational check out patient instruction and maintenance These responsibilities are outlined below and throughout this manual WARNING MARK 5 Lite units must not be used for or with any life supporting or life sustaining applications Patients unable to communicate discomfort while using this device may require additional monitoring Advise patients to immediately notify their Home Service Provider s and or physician s in case of an alarm or any discomfort As a Home Service Provider you must do all of the following Inspect the condition of each MARK 5 NUVO Lite unit immediately upon delivery to your business location Note any sign of damage external or internal on the delivery receipt and report it directly to both
18. enoid powered poppet valve assembly to control the air separation process There is a feed port that connects to the compressor and an exhaust port that discharges through an integral exhaust muffler There are three possible valve states as follows 1 Air feed connected to sieve bed A and exhaust connected to sieve bed B 2 Air feed connected to sieve bed B and exhaust connected to sieve bed A 3 Both ports open this is a very short time period during which air 4 pressure builds in the sieve beds 2010 8405 Rev C Page 16 of 42 The control valve of the MARK 5 NUVO Lite requires no scheduled maintenance If a valve does not function as required it is best to replace the complete sieve module as it is probable that one or both of the beds has been damaged 5 5 Sieve Bed Replacement CAUTION Do not expose molecular sieve contents of bed to air for an extended period of time Prolonged exposure of molecular sieve to the moisture in room air results in contamination and permanent damage to the sieve material Keep all openings to the sieve beds sealed during periods of storage NOTE It is recommended to replace the sieve beds and control valve as a complete assembly 5 5 1 Sieve Bed Removal 1 Set the unit s 1 0 ON OFF switch to the 0 OFF position and unplug the power cord 2 Remove the cabinet back Disconnect the compressor discharge 5 16 tube from the top the solenoid valve and the product tube from the
19. eshooting chart Make sure that the unit is leak free by testing all tubing connections and fittings with leak testing solution Protect circuit board from solution and start leak test at the heat exchanger following the air flow through the unit to the oxygen outlet Repair all leaks by tightening connections and fittings Set the concentrator at 5 l min and connect pressure test gauge to P2 at the top of the sieve beds Determine pressure parameters by observing high and low pressure points on the gauge It should cycle between approximately 9 psig and 32 psig 62 to 220 kPa If pressures are high or low refer to the troubleshooting chart Review troubleshooting chart to isolate and repair any other malfunctions The following diagnostic flow chart will help to isolate potential problems 2010 8405 Rev C Page 26 of 42 Low Oxygen Concentration Verify Oxygen Flow Rate Measure Air Pressure Low Pressure High Pressure Replace Air Inlet Filter Replace Muffler Check for Leaks Foams Check the Check Control ompressor Valve Normal Air Pressure Measure the Oxygen Pressure Low Pressure High Pressure Replace Muffler Foams Check the Replace Control Sieve Valve Module Normal O Check for leaks at the regulator outlet product tubing oxygen outlet 2010 8405 Rev C Page 27 of 42 6 4 Troubleshooting Chart Probable Cause
20. et and connect the fan leads Reinstall the back cabinet 57 Circuit Board Replacement There are two printed circuit boards within the MARK 5 NUVO Lite There is a printed circuit board that controls the alarm system functions and also a printed circuit board that controls the timing logic for the solenoid valves Consult the troubleshooting chart in Section 6 0 to determine which and when to replace the one of the printed circuit boards CAUTION The Printed Circuit Board PCB contain components that are sensitive to electrostatic discharge ESD that can damage the board if not handled properly As when handling any ESD sensitive PCB observe standard ESD safety procedures These procedures include the following Handle the PCB by the edges only Work a grounded ESD mat e Wear a grounded wrist strap Store in anti static bags only 5 7 1 Alarm Circuit Board Removal Note that the Circuit Board on the OCSI unit is different to the Circuit Board on the standard unit 1 Set the 1 0 ON OFF switch to the 0 OFF position and unplug the power cord 2 Remove the cabinet back Disconnect the 7 pin connector from the upper circuit board 4 Disconnect tubing from each end of the black sensor tube on the OCSI unit noting their position and orientation 5 Non OCSI units Cut tie wrap and remove pressure sensor line 2010 8405 Rev C Page 18 of 42 6 Remove the screws that
21. exchange follow the steps listed below 2010 8405 Rev C Page 15 of 42 1 Set the unit s 1 0 ON OFF switch to the 0 OFF position and unplug the power cord 2 Remove the cabinet back 3 Disconnect the suction tube and the discharge tube 4 Disconnect the two compressor power cable leads and the two leads to the capacitor 5 Disconnect the two springs from the compressor support plate Slide the compressor assembly from the cabinet 6 Remove compressor springs from the compressor with the two screws 7 Remove heat exchanger from compressor 8 Remove the heat exchanger fitting from the compressor Compressor Assembly Installation To install a new compressor follow the steps listed below 1 Perform the compressor removal procedure in reverse order 2 Leak test all connections 5 3 2 Capacitor Replacement The capacitor helps the compressor to start and run more efficiently If the compressor cannot start the capacitor may be defective and require replacement To replace the capacitor take the following steps 1 Set the unit s 1 0 ON OFF switch to the 0 OFF position and unplug the power cord 2 Remove the rear 3 Disconnect the two leads to the capacitor and clip the tie wrap securing the capacitor 4 To install the new capacitor connect the leads and replace the capacitor and install a new tie wrap clip excess after securing capacitor 5 4 Process Control Valve The MARK 5 NUVO Lite uses a sol
22. he WARNING CAUTION and NOTE messages They identify safety guidelines or other important information as follows Describes a hazard or unsafe practice that can result in severe bodily injury or death Describes a hazard or unsafe practice that can result in minor bodily injury or property damage Provides information important enough to emphasize or repeat WARNING CAUTION NOTE The following harmonized symbols pictograms used for non English language countries will be located in the User s Guide of the MARK 5 NUVO Lite unit Read the accompanying documents particularly the patient operating guide Store ship and use the device in an upright condition No smoking within five feet of this device oxygen carrying tubing or accessories E Indicates an alarm signal Do not use any oil or grease on or near the device RP OE 1 3 Functional Specifications Dimensions 35 6 cm long 22 9 cm wide 58 5 cm high 14 in long 9 in wide 23 in tall Weight 13 kg 30 Ib depending on sound attenuation package Electrical 120 VAC 60 Hz 10 lt 330 watts avg Requirements 230 VAC 50 Hz 10 lt 300 watts avg 230 VAC 60 Hz 10 lt 330 watts avg 2010 8405 Rev C Page 7 of 42 Capacity Max 5 liters per minute Accuracy Flow Valve 10 indicated flow rate 200 ml whichever is greater as per ISO 8359 Standard Concentration 2 liters per minute at gt 90 5 liters per minute at 90 6
23. he compressor length of stroke piston diameter speed of rotation and condition of seals The cup seals form the seal between the piston and the cylinder wall As the cup seals wear the output begins to gradually decrease 2010 8405 Rev C Page 14 of 42 This reduction in compressor output results in less air and thus less oxygen entering the sieve beds Therefore the production of oxygen decreases Because this drop in oxygen production occurs over a long period of time preventive maintenance on the compressor is not required You can continue a patient s therapy the MARK 5 Lite unit as long as the oxygen concentration level at the prescribed liter flow rate is within Nidek s specification limits Refer to Section 2 4 Air Flow Meter to 100 I min 1 bar Pressure Gauge Restrictor e Sound Level The sound level is largely determined by the condition of the compressor s bearings There are four bearings located within the compressor that allow the inner components of the compressor to rotate If the bearings wear to the point that they become loose and noisy the compressor becomes noticeably loud and needs servicing The life of a compressor is determined primarily by its operating temperature It is extremely important that the inlet cooling air filters are cleaned and replaced as required 5 3 1 Compressor Replacement Remove Compressor Assembly To remove the compressor assembly for
24. herefore pose a fire risk Use of the MARK 5 NUVO Lite must be restricted solely to oxygen therapy on medical prescription in compliance with the daily rate and duration Use in other circumstances may represent a hazard to patient health Do not use in a specifically magnetic environment MRI etc The MARK 5 NUVO Lite has an audible alarm intended to warn the user of any problems The user must determine the maximum distance away from the Nuvo based on the on the sound levels in the environment to ensure that the alarm is always audible Standards amp Regulations In compliance with UL60601 1 EN60601 1 para 6 82 b The manufacturer assembler installer or importer are not considered to be responsible for consequences or the safety reliability and characteristics of a device unless the assembly extensions adjustments modifications or repairs have been performed by persons authorized by the manufacturer the electrical installation of the corresponding premises complies with appropriate regulations and codes the device is used accordance with the instructions for its use If the replacement parts used for periodic servicing by an approved technician do not comply with the manufacturer s specifications the manufacturer is absolved of all liability in the event of an incident Do not open the equipment when it is powered on risk of electrocution This device complies with th
25. ier bottle if used and any other equipment accessories that may be required 6 Adjust the flow valve knob to the prescribed flow rate NOTE Do not measure oxygen concentration output after the product stream passes through a humidifier bottle erroneous readings will result and your oxygen concentration measuring device might be damaged 2010 8405 Rev C Page 10 of 42 MARK 5 Lite Concentration Specifications Liter Flow Specification 2 greater than 90 5 l min 90 6 5 3 3 0 Patient Instructions 3 1 General Instructions It is important that patients thoroughly understand how to operate the Nidek MARK 5 NUVO Lite unit This enables proper treatment as prescribed by a qualified licensed physician You must explain that the purpose of this therapy is to alleviate symptoms If patients experience any discomfort or the unit alarms they must notify their Home Service Provider and or physician immediately You as the Home Service Provider are responsible to see that each patient receives the Patient Manual Explain each step in the operation of the unit to the patient in reference to this manual 3 2 Routine Maintenance by the Patient To ensure accurate output and efficient operation of the unit the patient must perform two simple routine maintenance tasks e Clean the cooling air intake filter e Check the alarm system 3 2 1 Cleaning the Cooling Air Intake Cabinet Filter NOTE The patient
26. inet Back 14 5 2 2 Caster Replacement 14 2010 8405 Rev C Page 2 of 42 5 3 Compressor 14 5 3 1 Compressor Replacement 15 5 3 2 Capacitor Replacement 16 5 4 Process Control Valve 16 5 5 Sieve Bed Replacement 17 5 5 1 Sieve Bed Removal 17 5 5 2 Sieve Bed Installation 17 5 6 Cabinet Fan Replacement 18 5 7 Circuit Board Replacement 18 5 7 1 Circuit Board Removal 18 5 7 2 Circuit Board Installation 19 5 8 Product Regulator Check and Setting 19 5 8 1 Product Regulator Cleaning or Rebuilding 19 5 9 Pressure Switch Replacement 20 5 10 Circuit Breaker Replacement 20 5 10 1 Circuit Breaker Removal 20 5 10 2 Circuit Breaker Installation 20 5 11 1 0 ON OFF Power Switch Replacement 21 5 11 1 1 0 ON OFF Power Switch Removal 21 5 11 2 1 0 ON OFF Power Switch Installation 21 5 12 Buzzer Replacement 21 5 13 Hour Meter Replacement 21 5 14 Flow Valve Replacement 21 5 14 1 Flow Valve Removal 21 5 14 2 Flow Valve Installation 22 5 15 Power Cord Replacement 22 Section 6 0 Troubleshooting 6 1 Air Pressure Test P1 22 6 1 1 High Air Pressure 1 24 6 1 2 Low Air Pressure P1 24 6 2 Product Pressure Test P2 25 6 2 1 Low Product Pressure 25 6 2 2 High Product Pressure 25 6 3 General Troubleshooting 26 6 4 Troubleshooting Chart 27 6 5 Tool Kit and Pressure Test Gauge 31 2010 8405 Rev C Page 3 of 42 Appendices Exploded A1 Standard Pneumatic Diagram 32 Drawings 2 OSCI Pneumatic Diagram 32 A3 1
27. it remains within specifications at the prescribed flow rate Refer to Section 2 4 4 1 1 Cooling Air Filter The external cooling air filter is located on the back of the unit You can easily remove it by hand Instruct the patient to clean this filter weekly Refer to Section 3 2 1 NOTE The filter may require more frequent cleaning if the MARK 5 NUVO Lite unit operates in a harsh environment such as a house heated by wood kerosene or oil or one with excessive cooking cigarette smoke or atmospheric dust 4 1 2 Bacteria Filter Replacement The bacteria filter must be replaced after every 2 years or 15 000 hours of use 1 Set the 1 0 ON OFF switch to the 0 OFF position and unplug the power 2 the cabinet back to locate the bacteria filter NOTE Observe the position of the filter before removal 3 Separate the silicone tubing from both sides of the filter 4 Install the new filter with the inlet side in the same position as before Push the tubing together so that it overlaps the barbs of the bacteria filter connections 2010 8405 Rev C Page 12 of 42 5 Record information about the bacteria filter replacement on the History Record Card as recommended in Section 4 1 5 6 Reinstall the cabinet back 4 1 3 Compressor Filter Replacement The compressor air inlet filter requires changing every 24 months or 20 000 hours of use 1 Set the unit 1 0 ON OFF switch to the 0 OFF position and unplug the power cord
28. must clean this filter weekly as described below The filter may require daily cleaning if the MARK 5 NUVO Lite unit operates in a harsh environment such as a house heated by wood kerosene or oil or one with excessive cigarette smoke 1 Remove the dirty cooling air filter from the back of the MARK 5 Lite unit 2 Wash the dirty filter in warm water with household detergent and rinse Use a soft absorbent towel to remove excess water Reinstall the clean cooling air filter on the grille in the back of the unit 2010 8405 Rev C Page 11 of 42 3 2 2 Checking the Power Alarm System See Procedure described in Paragraph 2 3 1 4 0 Home Service Provider Maintenance 41 Routine Maintenance The MARK 5 NUVO Lite unit has three filters that require scheduled maintenance and replacement To ensure that the output of oxygen from the unit is within specification you must perform an oxygen concentration test Test the unit upon delivery to a patient and at periodic intervals Home Service Providers based on their expertise and documentation may establish and implement their own practices for checking oxygen concentration The interval established may be longer or shorter than 90 days which is the default time period recommended for providers who do not choose to establish their method Nidek does not require preventive maintenance on the concentrator You do not need to perform any maintenance as long as the MARK 5 NUVO Lite un
29. ns An improperly operating control valve Confirm that the control valve does not have a leak gt A leak in the unit which allows system pressure to escape Leak test the unit with reduced output Ensure that the concentration level at the desired liter flow is within specifications listed in Section 2 4 If it is below specification replace or repair the compressor 2010 8405 Rev C Page 25 of 42 6 2 2 High Product Pressure P2 Higher than normal operating pressure may indicate any of the following 6 3 gt A restrictive exhaust muffler which does not allow the waste purge gas to exit the system freely Check exhaust muffler for any restrictions Contaminated sieve beds Change the sieve beds General Troubleshooting Before reviewing the troubleshooting chart the following steps may be useful to isolate any malfunctions 1 Turn the concentrator on If unit does not turn on refer to troubleshooting chart Make sure all filters are clean Connect test pressure gauge to the outlet fitting of the unit The pressure should read approximately 7 2 psig 50 kPa Connect test pressure gauge to the P1 test port on the module The pressure should be cycling between approximately 10 and 34 psig 70 and 235 kPa Make sure the unit is cycling properly by observing the pressure gauge cycle between a high and a low pressure If the unit is not cycling properly refer to troubl
30. ns Unplug the power cord from the wall outlet and set the 1 0 ON OFF switch to the ON position If the unit has been stored for a prolonged period Allow unit to run for approximately 10 minutes to charge the capacitor and re test the unit This should immediately activate the intermittent audible alarm If it does not refer to the troubleshooting chart in Section 6 0 of this manual 2 4 Oxygen Concentration Test and Specification To ensure that the output of oxygen from the device is within specification you must perform an oxygen concentration test Test the unit upon delivery to a patient and at periodic intervals Home Service Providers based on their expertise and documentation may establish and implement their own plans for checking oxygen concentration Consult the proper Nidek User s Guide for recommended interval for testing 1 If an oxygen humidifier bottle is used remove it from the oxygen outlet 2 Connect a calibrated oxygen concentration analyzer to the oxygen outlet 3 Set the 1 0 ON OFF power switch to the ON position It takes approximately five minutes for the oxygen concentration to stabilize Take oxygen concentration readings over a period of several minutes to reduce any cyclic variations 4 Verify that the product flow rate delivered by the unit matches the patient s prescription and does not exceed the capacity of the unit 5 Disconnect the oxygen analyzer and reconnect the humidif
31. oncentrator allows for easy access and removal of most components This allows you to perform scheduled maintenance repair and replacement of parts with minimal time and effort The inlet air filter is conveniently located behind the cooling air filter on the cabinet back CAUTION For your safety be sure to set the 1 0 ON OFF switch to the 0 OFF position and unplug the power cord before you service the MARK 5 NUVO Lite Oxygen Concentrator NOTE Record all scheduled maintenance Refer to Section 4 0 5 2 Cabinet Removal 5 2 1 Removing Cabinet Back Lay the device on its front to access the cabinet back remove four screws two at the top near the handle and two near the bottom of the cabinet 5 2 2 Caster Replacement The casters are a push in type that does not require any fastener Lay the device on its back to access the casters from the bottom Pull them straight out away from the bottom 5 3 Compressor The compressor is the pump within the oxygen concentrator that supplies air to the separation process performed by the sieve beds The pressure generated by the compressor forces oxygen to flow out of the top of the sieve columns The compressor is the likely cause of two potential specific problems a An insufficient amount of air is supplied to the process and b An excessive sound level e Air Supply Compressor output refers to how much compressed air the compressor can produce This depends upon the model of t
32. regulator flow control valve and bacteria filter The flow control valve controls the flow rate of oxygen delivered to the patient The MARK 5 NUVO Lite unit delivers up to 95 oxygen concentration at flow rates from 125 to 5 I min The remaining constituents of the product gas stream are nitrogen and argon both of which are part of the air we breathe are inert and are completely safe 2010 8405 Rev C Page 8 of 42 2 2 Operational Check Nidek runs each device through a burn in period and tests every MARK 5 NUVO Lite Oxygen Concentrator thoroughly after manufacture before releasing for shipment As the home service provider it is your responsibility to perform the following test to ensure that no damage occurred in shipping or handling 1 Open and inspect all concentrator cartons upon receipt Unpack each unit and remove it from its carton Inspect the unit itself for damage If the exterior of the carton is damaged or the unit itself is damaged note it on the freight bill signed by the driver 2 Plug in the power cord of the unit and set the 1 0 ON OFF switch to the ON position Check to see that the following occurs e The compressor runs listen for the sound Exhaust air flows out of the bottom rear of the unit e OPTIONAL for Units Equipped with Oxygen Concentration Status Indicator OCSI The OCSI green light remains off until the oxygen concentration reaches 85 3 82 2 for 50 Hz units approxima
33. ressures 2010 8405 Rev C Page 22 of 42 Inlet air source from compressor Product output to flow control valve Figure 6 1 1 normal operating configuration OSCI unit Inlet air source product output from compressor to flow control valve To standard board pressure sensor Figure 6 1 2 normal operating configuration standard unit 2010 8405 Rev C Page 23 of 42 P2 test port Figure 6 1 3 configuration with test ports 6 1 1 High Operating Air Pressure P1 Higher than normal operating pressure may indicate any of the following gt A restrictive exhaust muffler which does not allow the waste purge gas to exit the system freely Contaminated sieve beds Change the sieve beds 6 1 2 Low Operating Air Pressure P1 Lower than normal operating pressure may indicate any of the following gt A restriction in the suction resonator or air intake filter this limits the amount of room air available to the compressor Disconnect the suction tube at the compressor and allow the unit to operate without the suction resonator to see if normal operating pressure returns An improperly operating control valve Confirm that the control valve does not have a leak gt A leak in the unit which allows system pressure to escape Leak test the unit 2010 8405 Rev C Page 24 of 42 Acompressor with reduced output Ensure that the concentration level at the desired liter flow is within specifica
34. runs with Leak test and repair leak intermittent low pressure alarm and low oxygen concentration 2010 8405 Rev C Page 28 of 42 Probable Cause Solution Compressor runs with intermittent high pressure alarm and low oxygen concentration Compressor relief valve releases popping sound Constant alarm with 1 0 ON OFF switch in ON position Circuit breaker repeatedly trips Alarm does not sound Flow fluctuates 2010 8405 Defective sieve beds Restriction in exhaust muffler Defective valve Defective control valve Contaminated sieve beds Defective relief valve Defective circuit breaker Defective capacitor Defective compressor Defective circuit board Faulty electrical connection Faulty electrical connection Defective 1 0 ON OFF switch Defective buzzer Defective pressure sensor Improperly set or faulty product regulator Leak Worn compressor Defective flow valve Kinked tubing Replace sieve beds Replace or clean muffler Replace sieve module Replace sieve module Replace sieve module Replace sieve module Replace relief valve Replace circuit breaker Replace capacitor Replace compressor Replace circuit board Repair electrical connection Repair electrical connection Replace 1 0 ON OFF switch Replace board Replace and test control board Check regulator setting clean repair or replace regulator Leak test
35. tely two minutes e After performing above steps remove the power cord from the wall outlet actuate the 1 0 ON OFF switch to the ON position and note that the audible alarm sounds intermittently See Section 2 3 If the unit does not initial sound off plug the unit and allow the unit to run approximately 10 minutes to charge the capacitor and re perform the test Move the switch to the 0 OFF position 3 Turn the flow valve adjustment knob clockwise until it stops wide open The flow valve should indicate 5 liters min and the output of the unit should be 5 liters min If not refer to Section 5 8 to adjust the product regulator 4 Perform an oxygen concentration test as described in Section 2 4 2 3 Alarm System The MARK 5 Lite Oxygen Concentrator is equipped with capacitor powered alarm system which sounds an intermittent alarm when a power failure occurs and a continuous alarm when one or more cycle variables are not within specification It sounds an alarm if the high or low pressure indicators are activated or if the optional OCSI detects lower than predetermined levels of oxygen concentration The alarm remains on until you correct the alarm condition or you set 2010 8405 Rev C Page 9 of 42 the 0 ON OFF switch to the 0 OFF position Refer to Section 6 0 for a list of probable alarm causes 2 3 1 Power Failure Alarm Test To test the power failure alarm perform the following actio
36. tions listed in section 2 4 If it is below specifications replace or repair the compressor 6 2 Product Pressure Test P2 Testing the product pressure is a useful diagnostic tool when a concentrator has low purity and requires servicing Units functioning normally do not require operating tests Use the following procedure to test the product pressure of the unit 1 Set the 0 ON OFF switch to the 0 OFF position and unplug the power cord 2 Remove the cabinet rear 3 Remove the cap from the regulator test port and install the test port tee Figure 6 1 1 amp 6 1 2 shows the normal operating configurations for each type of unit Figure 6 1 3 shows the installation of the test ports 4 Connect the pressure test gauge to the P2 test port 5 Plug in the power cord and set the 1 0 ON OFF power switch to the ON position Set the flow meter to 5 l min and allow the unit to run at least five minutes 6 Observe the maximum and minimum readings on the pressure test gauge The maximum reading should not exceed 32 psig 220kPa The minimum reading should not be less than 9 psig 62 kPa 6 2 1 Low Product Pressure 2 Lower than normal operating pressure may indicate any of the following An air intake filter that limits the amount of room air available to the compressor Disconnect the suction tube at the compressor and allow the unit to operate without the suction resonator to see if normal operating pressure retur
37. x wrench Reinsert the module assembly and reinstall the cabinet back 5 8 1 Product Regulator Cleaning or Rebuilding Clean or rebuild the product regulator if the regulator cannot be adjusted l Set the 1 0 ON OFF switch to the 0 OFF position and unplug the power cord 2 Remove the back cabinet 2010 8405 Rev C Page 19 of 42 7 8 9 10 11 12 13 5 9 Remove the regulator from the tee on top of the solenoid valve assembly Adjust the product regulator fully counterclockwise to unload the spring This makes disassembly and reassembly easier Remove the diaphragm Clean or replace it Use a hex head screwdriver to unscrew the diaphragm stem guide located in the center of the regulator body to gain access to the seat Remove the seat Be careful not to lose the spring located behind the seat Replace the seat or clean by blowing clean air on and around it With the spring behind the seat screw the diaphragm stem guide back into the body of the regulator Do not over tighten Install a clean or replacement diaphragm Put the large spring and slip ring into the bonnet and screw the bonnet onto the regulator body Reinstall the regulator Reset the product regulator as described in Section 5 8 1 High or Low Pressure Switch Replacement Standard Unit Non OCSI The high and low pressure alarms are activated by a pressure transducer located on the alarm circuit board adjacent to the mains switch

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