第1章 维修与拆卸 - Integral process
Contents
1. 7 3 2 Parts List 1 2 3 4 5 7 10 Front housing for VS 600 11501825090 Waterproof strip for front and rear housing Display lens for VS 600 En 051 001358 00 Keypad PCBA for VS 600 051 001358 00 Keypad board adjusting 043 003153 00 sleeve Long poron cushion 115 018251 00 Segment code display Display metal sheet for VS 600 7 3 Keypad board cushion 047 010363 00 de VE Er 0000 PT3X10 a pan E MEN cross recessed M3X6 051 001363 00 001363 00 Main Main board PCBA VS 600 PCBA VS 600 051 001363 00 001363 00 Be 049 000573 00 Silicon buttons VS 600 049 000573 00 E 7 4 Main Bracket Assembly 7 4 1 Exploded View 7 4 2 Parts List en Josee FRUpartnumber BEEN LN dE p w washer Hoo mem ee o CE Lo mess of d ERI plate 4 Serompanhesd Screw pan Screw panhead Grounding pole he CC 20 NC 7 er support between the 009 003237 00 power management 009 003237 00 board and power board Ov N 7 5 Power Management Board Assembly 7 5 1 Exploded View a S o i 7 5 2 Parts List ICE muere mm Power management 051 001458 00 board service kit PCBA Power without Masimo 1 j manag2. No taped notes that may suggest device deficiencies or operator concerns A 3 Device Labeling Check the labels provided by the manufacturer or the healthcare facility are present and legible B Mainunit label B Integrated warning labels A 4 Protective Earth Resistance Protective Earth Resistance is measured using the RED test lead attached to the DUT Protective Earth terminal or enclosure Select the test current by pressing SOFT KEY 3 to toggle between 1AMP 10AMP and 25AMP The front panel outlet power is turned off for this test The following conditions apply L1 and L2 Open Preparation 1 First select the test current that will be used for performing the Protective Earth Resistance test by pressing AMPERES SOFT KEY 3 Connect the test lead s between the RED input jack and the GREEN input jack Press CAL LEADS The 601PRO will measure the lead resistance and if less than 0 150 Ohms it will store the reading and subtract it from all earth resistance readings taken at the calibrated current Calibration in Progress Iscalez1 004 Lead Resistance Too High Connect test lead from RED input jack To GREEN input jack ED we a CD CD GD If the calibration fails the previously stored readings will be used until a passing calibration has occurred NWARNING e During Earth Resistance testing the DUT must be plugged into the 601PRO front outlet If the DUT fails Earth Resistance discontinue tests and labe
3. B Change another probe to confirm if the fail is caused by console B Ifthe leakage current measurement tests fail on a new unit and if situation can not be corrected submit a Safety Failure Report to document the system problem Remove unit from operation B Ifallelsefails stop using and inform the Customer Service Engineer for analysis and disposal LIMITS For UL60601 1 300 uA in Normal Condition 1000 HA in Single Fault Condition For IEC60601 1 500 uA in Normal Condition 1000 HA in Single Fault Condition A 6 Patient Leakage Current Patient leakage currents are measured between a selected applied part and mains earth All measurements have a true RMS only response Preparation Perform a calibration from the Mains on Applied Part menu The following outlet conditions apply when performing this test B Normal Polarity Earth Open Outlet ON Normal Polarity Outlet ON B Normal Polarity L2 Open Outlet ON Reversed Polarity Outlet ON B Reversed Polarity Earth Open Outlet ON Reversed Polarity L2 Open Outlet ON NWARNING e ifall ofthe applied parts correspond to the instrument type the applied parts will be tied together and one reading will be taken If any of the applied parts differ from the instrument type all applied parts will be tested individually based on the type of applied part This applies to Auto and Step modes only To Perform the Test 1 Fromthe MAIN MENU or with the outlet unp
4. Note The equipment which sell to America shall comply with the requirement of UL60601 1 others shall comply with the requirement of IEC60601 1 Name Signature Date FOR YOUR NOTES PN 046 004927 00 1 0
5. The below figure displays Ki VS 600 Update Tool Make package Select Package D luhxisoftware packgagelsystem pkg Pot Status Percent Time fs 5 Set Port to COM1 And then click Start Ei 45 500 Update Tool Status Start connection 6 Make sure the monitor is power off press and hold three buttons Ce and or firstly and then press button at the same time after about 2 seconds release the three buttons the monitor enters upgrade mode and starts software u 896 upgrade automatically the display screen is black while the indocator built in button lights green The corresponding prompt messages are displayed on PC When software upgrade is finished prompt Update succed displays Restart the monitor and check if the software is correctly upgrade 8 6 A Electrical Safety Inspection The following electrical safety tests are recommended as part of a comprehensive preventive maintenance program They are a proven means of detecting abnormalities that if undetected could prove dangerous to either the patient or the operator Additional tests may be required according to local regulations All tests can be performed using commercially available safety analyzer test equipment These procedures assume the use of a 601PROXL International Safety Analyzer or equivalent safety analyzer Other popular testers complying with IEC 60601 1 used in Europe such as Fluke Metron or Gerb may require m
6. Monitor Connect the two wires orange wires of Temp probe connector to the two ends of the resistance box Set the resistance box to 9882 0 O corresponding temperature is 25 3 C Verify displayed tempreture value on monitor is within 25 3 0 1 C Set the resistance box to 6037 1 Q corresponding temperature is 37 0 C Verify displayed tempreture value on monitor is within 37 0 0 1 C Set the resistance box to 4619 2 O corresponding temperature is 43 7 C ger ux OE M oda Verify displayed tempreture value on monitor is within 43 7 0 1 C Please contact our service personnel if the Temp test fails NOTE e Due to the different application environment and the test object in vivo and vitro conditions there is deviations in the measurement result The maximum deviation of 2 5 C may exist in predictive Temp measurement by liquid bath techniques 4 5 Electric safety tests For details about electric safety tests refer to Appendix A Electrical Safety Inspection 4 6 Battery Check Tool required B None Functional Test 1 Ifthe equipment is installed with a battery remove the battery first 2 Verify that the equipment works correctly when running powered form an AC source 3 Insert the battery per the procedures provided in the Operator s Manual 4 Remove the AC power cord and verify that the equipment still works correctly Performance Test Perform the test by referring to the Battery chapter in the Operator s Manu
7. ORE CT RII IE IR RUD PRI IRE RU 5 1 5 5 Power on OF FANS ana essen Ud nobii eie etc 5 1 3 3 2 Display Fal UGS RR 5 2 3 3 3 BUtlON Palestino 5 2 3 3 4 Batten Fare S nasser dieti d RR cau m AC ROS RARUS 5 2 5 35 Module derectlVe anne ie 5 3 5 3 0 Software Upgrade Problems tn sre anna 5 3 5 4 EHOT COJO Si 5 3 6 Disassembly and Repa lf mE M 6 1 nn ret rr ERE EP nnm 6 1 6 2 Preparations for Disassembly rad 6 1 6 Disassemblinig the Main Unit ansehe 6 2 6 3 1 Disassembling the Temp Module Optional an aaanoenenseneenenoenssnensens 6 2 6 3 2 Separating the Front and Rear Half of the Monitor sse 6 2 6 3 3 Removing the Parameter Connector Panel Assembly sss 6 3 6 3 4 Disassembling the Main Bracket Assembly an eaneanoeneunenoeneeneeneeneesenseveeneen 6 4 6 3 5 Removing the Parameter Board SpO Optional and Power Management Board6 5 6 3 6 Disassembling Pumps and Valves NIBP optional esee 6 6 6 3 7 Disassembling AC DC Power Board and Battery Converter Board 6 6 6 4 Disassembling the Front Housing Assembly eee snsensenonseneeneveenennenoenensensvensens 6 7 6 4 1 Removing the Main Board nnuanenseseeneveeneensneensveensunenennensensvaeneensveenesneneensnseneens 6 7 642 Removing the Display ask Mi e eo pet o reete stet br BR eee 6 8 643 Removi
8. Within 10 s after you hear a beep press and hold to enter the maintenance mode Then press to display the NIBP accuracy test interface Inthe PR parameter area the code 555 is displayed 4 Press to start accuracy test The real time pressure is displayed in the mean pressure area In this process you can press to terminate the current accuracy test An invalid value is displayed in the mean pressure area 5 Check the manometer values and the monitor values Both should be 0 mmHg 6 Raise the pressure in the metal vessel to 50 mmHg with the balloon pump Then wait for 10 s to let the measured values become stable 7 Compare the manometer values with the monitor values The difference between the manometer and displayed values should be 3 mmHg 8 Raise the pressure in the metal vessel to 200 mmHg with the balloon pump Then wait for 10 s to let the measured values become stable Repeat step 7 If the difference between the manometer and displayed values is greater than 3 mmHg contact your service personnel NOTE Youcanusean NIBP simulator to replace the balloon pump and the reference manometer to perform the test You can use an appropriate cylinder and a cuff instead of the rigid vessel 4 4 2 3 NIBP Calibration Contact the service personnel for NIBP calibration 4 7 4 4 3 Temp Test Tool required B Resistance box with accuracy above 0 1 O Connet the Temperature probe to
9. and Rollstand Instructions for Use PN 0010 20 42934 caurion Use mounting brackets we supply or approve If other compatible mounting bracket is used be sure it can be safely used on the vital signs monitor The mounting bracket should be installed by our qualified service personnel or engineers who have adequate knowledge on it If other mounting solution is used the installation personnel and the customer should verify if it can be safely used on the equipment and the customer assume the responsibility for any risk resulting from that 3 4 Preparation for Power on 1 Before you start to make measurements check the equipment for any mechanical damage and make sure that all external cables plug ins and accessories are properly connected Plug the power cord into the AC power source If you run the equipment on battery power ensure that the battery is sufficiently charged Press the button on the front panel to turn on the equipment FOR YOUR NOTES 4 Testing and Maintenance 4 1 Introduction To ensure the equipment always functions normally qualified service personnel should perform regular inspection maintenance and test This chapter provides a checklist of the testing procedures for the equipment with recommended test equipments and frequency The service personnel should perform the testing and maintenance procedures as required and use appropriate test equipments The testing procedures provided in
10. lists of the main unit It helps the engineer to identify the parts during disassembling the monitor and replacing the parts This manual is based on the maximum configuration Your equipment may not have same parts and the quantity of the screws or stacking sleeves etc may be different with those included in the parts lists NOTE The part number listed in the Parts List is only for checking the FRU part number which is also included in the Parts List Please provide the FRU parts number if you want to purchase the spare parts 7 2 Main Unit 7 2 1 Exploded View 7 1 7 2 2 Parts List Description FRU part number Remarks Parameter connector 115 017682 00 panel assembly for 115 017686 00 with no SpO VS 600 Power management 051 001458 00 Mindray Nellcor board assembly for vs 60d 051 091360 0 115 017679 00 NIBP valve assembly 115 017679 00 Screw assembly en 801 9261 00040 00 Fixing strip Front housing assembly i for VS 600 115 018250 00 front cover FRU Main bracket assembly for VS 600 Rubber foot Battery door assembly z Predictive Temp module 115 017687 00 E 3 Cable between NIBP 009 003238 00 module and power 009 003238 00 management board Screw pan head Phillips M3X8 Cable between the main 009 003248 00 board and power 009 003248 00 management board 4 150177200 E alo OCN MH 7 3 Front Housing Assembly 7 3 1 Exploded View
11. main board is the control center of the equipment It provides communication and display functions including Keypad Communication with SpO board and NIBP module through serial ports starting parameter measurement and reading measured results Communication with Predictive IR Infrared Radiation Temp module through serial ports Communication with power management board through serial ports Extending an RS232 serial port Control over the Segment code LCD display through 12C Providing backlight drive for segment code display Recognition of keypad actions and providing corresponding response Control over the beeper through IO port and Providing 24 hour timing via the inner RTC The keypad consists of elements like keypad and AC Battery indicator etc 2 5 Rear Housing Assembly Power management and interface board SpO2 board NIBP module Rear housing assembly consists of power module AC DC power management and interface board including SpO isolation power battery compartment NIBP module and SpO board including three types of configuration i e Mindray Masimo and Nellcor AC DC Power Module The AC DC power board transforms the input AC into DC power which is the power source for all voltages in the equipment Power management and interface board The power management interface board mainly provides the following functions B Charge and discharge of battery and charge detection B DC
12. this chapter are intended to verify that the equipment meets the performance specifications If the equipment or a module fails to perform as specified in any test repairs or replacements must be done to correct the problem If you have any question contact our Customer Service Department NcAUTION e All tests should be performed by qualified service personnel only Service personnel should acquaint themselves with the test tools and make sure that test tools and cables are applicable 4 1 1 Test Equipment See the following sections 4 1 2 Test Report Upon the completion of the tests the table of preventative maintenance test reports and the table of maintenance test reports in this chapter should be kept properly 4 1 3 Preventative Maintenance Below are preventative maintenance tests which need to be performed on the monitor The recommended frequency of preventative maintenance is at least once per year See the following sections for detailed maintenance procedures B Visual Inspection B NIBP test and calibration 4 1 4 Recommended Frequency i i Preventative Maintenance Visual Inspection When first installed or reinstalled Performance test SpO gt test 1 If the user suspects that the measurement is Pressure check incorrect NIBP test and Leakage test 2 Following any repairs or replacement of relevant calibration module Module Calibration 3 At least once every two years Note At least once a y
13. with the SpO board and the connector panel assembly in the service kit into the main unit as described in 6 3 Disassembling the Main Unit 8 1 2 2 Upgrading Masimo SpO List of upgrade package B A Power Management Board Assembly and B Aparameter connector panel assembly 8 1 1 Remove the power management board assembly and connector panel assembly as described in 6 3 Disassembling the Main Unit 2 Install the power management board assembly and the connector panel assembly in the service kit into the main unit as described in 6 3 Disassembling the Main Unit 8 1 3 Upgrading Temp List of upgrade package B ATemp module with cables and B Two M3x6 screws Remove the decorative cover from the Temp module connector Install the Temp module onto the main unit as described in 6 5 Disassembling the Temp Module Optional 8 1 4 Enabling Parameter Functions 1 Turnon the monitor Within 10 s after you hear a beep press and hold and C keys simultaneously and the system starts to identify the currently configured modules The labels of parameters start to flash till the end of module identification Then the results are displayed in corresponding parameter areas NIBP and Temp parameter areas an means this module is configured on this equipment while Mz means the contrary SpO parameter area Number 1 means MindraySpO module 2 means MindraySpO module 3 means NellcorSpO module PRparamet
14. 1 NOTE Theenvironmental specifications of unspecified parameters are the same as those of the main unit 3 2 3 Electrical Requirements Check that the system cables power cords and power plugs are not damaged and that the pins are not loose In case of any damage remove it from use N WARNING e Only power sockets with protective grounding can be used Usethe supplied power cord only Ifyou doubt the completeness of the installation and cabling of the external protective cables disconnect the equipment from the power line and operate it on battery Otherwise patient or operator might be shocked Voltage 100 to 240V AC Frequency 50 60 Hz Current 0 9 to 0 5A 3 3 Equipment Installation Follow the procedure below to install the equipment 1 Checkthe quantity of equipment and accessories as per the packing list 2 Check for mechanical damages on the equipment and accessories 3 Install the battery optional For detailed operations please refer to the Operator s Manual of the vital signs monitor Connect AC power Connect the accessories The vital signs monitor can be mounted on a wall bracket or on a trolley support The wall bracket or trolley support can be ordered optionally Each type of mounting bracket is delivered with a complete set of mounting hardware and instructions For detailed installation information please refer to Wall mount Bracket Instructions for Use PN 0010 20 42933
15. DC conversion outputs 12V and 5V DC power B Control over power On Off key and AC BAT indicator E Communication transmission among parameter modules 2 4 B Providing isolation power for Mindray OEM SpO module and B Providing external connectors and also filter and protection for these connectors NIBP Module The NIBP module consists of blood pressure measurement board and pump and valve assembly providing measurement acquisition of blood pressure data The main functions of the NIBP module are B NIBP measurement and B Data exchange with the main board through the serial ports SpO board The independently developed Mindray SpO2 board provides SpO measurement as good as other boards but with smaller size and lower consumption The power management and interface board is also compatible with Nellcor NELL 1 SpO board and Masimo MS 2013 SpO board The SpO board collects SpO signals processes SpO algorithm and sends measurement results to the main board The power management interface board provides isolation power for it 2 6 External Module An external Temp module can be extended on the monitor The independently developed Mindray Temp module consists of an isolation power board Temp measurement board and probes The Temp measurement board collects Temp signals processes algorithm and sends measurement results to the main board FOR YOUR NOTES 3 Equipment Installation 3 1 Unpacking the Equipme
16. VS 600 Vital Signs Monitor Service Manual Intellectual Property Statement SHENZHEN MINDRAY BIO MEDICAL ELECTRONICS CO LTD hereinafter called Mindray owns the intellectual property rights to this product and this manual This manual may refer to information protected by copyrights or patents and does not convey any license under the patent rights of Mindray nor the rights of others Mindray does not assume any liability arising out of any infringements of patents or other rights of third parties mindray E and MINDRAY arethe registered trademarks or trademarks owned by Mindray in China and other countries Revision History This manual has a revision number This revision number changes whenever the manual is updated due to software or technical specification change Contents of this manual are subject to change without prior notice The version information of this manual is as follows B Version number 1 0 B Release time May 2013 Copyright 2013 Shenzhen Mindray Bio Medical Electronics Co Ltd All rights reserved Preface Manual Purpose This manual provides detailed information about the assembling dissembling testing and troubleshooting of the equipment to support effective troubleshooting and repair It is not intended to be acomprehensive in depth explanation of the product architecture or technical implementation This manual is based on the maximum configuration and therefore some contents ma
17. age and frequency ratings of the power line are the same as those indicated on the unit s label or in this manual Protect the equipment from damage caused by drop impact strong vibration or other mechanical force during servicing 1 2 4 Notes NOTE Referto Operator s Manual for detailed operation and other information 1 3 Equipment Symbols NOTE e Notall the symbols listed below are applied to your equipment Caution Consult accompanying Neonate documents this manual YO qmm Alternating current AC Equipotentiality DEFIBRILLATION PROOF TYPE CF APPLIED PART Date of manufacture Manufacturer Serial number D 4 Insertion Direction Protecti inst fluid IPX1 en ui NIBP Start Stop key No alarming system The following definition of the WEEE label applies to EU member states only This symbol indicates that this product should not be treated as household waste By ensuring that this product is disposed of correctly you will help prevent bringing potential negative consequences to the environment and human health For more detailed information with regard to returning and recycling this product please consult the distributor from whom you purchased it For system products this label may be attached to the main unit only 2 Theory of Operation 2 1 Overview The monitor is intended for spot check monitoring physiologic parameters including SpO PR NIBP and TEMP on adult pediatric and
18. al Condition 50yAin Single Fault Condition A 6 For BF applied parts 100pA in Normal Condition 500uA in Single Fault Condition A 7 Mains on Applied Part Leakage The Mains on Applied Part test applies a test voltage which is 11096 of the mains voltage through a limiting resistance to selected applied part terminals Current measurements are then taken between the selected applied part and earth Measurements are taken with the test voltage 11096 of mains to applied parts in the normal and reverse polarity conditions as indicated on the display The following outlet conditions apply when performing the Mains on Applied Part test B Normal Polarity B Reversed Polarity Preparation To perform a calibration from the Mains on Applied Part test press CAL SOFT KEY 2 1 Disconnect ALL patient leads test leads and DUT outlet connections 2 Press CAL to begin calibration as shown Disconnect All Patient Leads and OUTLET connections CAL Gay BD TT A e If the calibration fails the previously stored readings will be used until a passing calibration has occurred Also the esc stop key has no effect during calibration 3 When the calibration is finished the Mains on Applied Part test will reappear NWARNING e A2 beep per second signal indicates high voltage present at the applied part terminals while a calibration is being performed e High voltage is present at applied part terminals while measu
19. al and verify the operating time of the battery meets the product specification 4 8 4 7 Maintenance Mode 4 7 1 Entering Quitting Maintenance Mode 1 Start the monitor Within 10 s after you hear a beep press and hold Ce to enter the maintenance mode 2 Press Ce repeatedly to switch to different settings including NIBP unit setup Temp unit setup system time setup NIBP leakage test NIBP accuracy test version information restoring factory configuration work time information screen brightness adjustment and DIAP communication setup G 3 Press and hold to turn off the equipment When the equipment is started next time the changed settings take effect 4 7 2 Checking Version Information 1 Enter maintenance mode 2 Press Cc and switch to version information 3 Press to toggle version information The following information is displayed on the monitor System software version NIBP module version SpO2 module version Temp module version and Power management software version The indications of codes are listed below Version Screen display Indication of codes System software 030 000 indicates version version 03 00 00 NIBP module hardware 540 indicates version 05 04 00 version Mindray SpO2 module 223 indicates version 2 2 3 version Masimo Nellcor SpO TB EB AN 1210 indicates version 1 2 1 0 Temp module version 502 indicates version 5 0 2 P
20. ay be required Philips screwdrivers Tweezers Sharp nose pliers Clamp 6 2 Preparations for Disassembly Before disassembling the equipment finish the following preparations A Stop monitoring turn off the equipment and disconnect all the accessories and peripheral devices Disconnect the AC power source and remove the battery WARNING Before disassembling the equipment be sure to eliminate the static charges first When disassembling the parts labeled with static sensitive symbols make sure you are wearing electrostatic discharge protection such as antistatic wristband or gloves to avoid damaging the equipment Properly connect and route the cables and wires when reassembling the equipment to avoid short circuit Select appropriate screws to assemble the equipment If unfit screws are tightened by force the equipment may be damaged and the screws or part may fall off during use causing unpredictable equipment damage or human injury Follow correct sequence to disassembly the equipment Otherwise the equipment may be damaged permanently Be sure to disconnect all the cables before disassembling any parts Be sure not to damage any cables or connectors Be sure to place removed screws and disassembled parts properly preventing them from being lost or contaminated Place the screws and parts from the same module together to facilitate reassembling To reassemble the equipment first assemble the assemblies and
21. dicates the leakage test is passed and that the system has no leakage If is displayed it indicates the system may have a leakage Check the tubing and connections for leakages If you ensure that the tubing and connections are all correct perform a leakage test again If the problem persists contact your service personnel You can either perform a manual leakage test 4 5 Perform steps 1 4 as described in Section 4 4 2 2 NIBP Accuracy Test Raise the pressure in the rigid vessel to 250 mmHg with the balloon pump Then wait for 5 seconds to let the measured values becoming stable Record the current pressure value and meanwhile use a time counter to count the time Then record the pressure value after 60 s Compare the two pressure values and make sure the difference should not be greater than 6 mmHg 4 4 2 2 NIBP Accuracy Test Tool required T shape connector Appropriate tubing Balloon pump Rigid Vessel with volume 500 25 ml Reference manometer calibrated with accuracy equal to or better than 0 75 mmHg Follow this procedure to perform the accuracy test 1 Connect the equipments as shown below Monitor Standard sphygmomanometer Connector for NIBP cuff Appropriate tubing Balloon pump Before inflation check that the reading of the manometer is O If not open the balloon pump to let the whole airway open to the atmosphere Close the balloon pump after the reading is O Start the monitor
22. e fail is caused by console If the leakage current measurement tests fail on a new unit and if situation can not be corrected submit a Safety Failure Report to document the system problem Remove unit from operation If all else fails stop using and inform the Customer Service Engineer for analysis and disposal For CF 9 applied parts 50 HA For BF applied parts 5000 uA ELECTRICAL SAFETY INSPECTION FORM Overall assessment Test item 1 2 3 4 5 6 7 Test item 1 2 3 Opened repair type not replace the power part including 4 2 2 5 9 9 item 15 transformer or patient circuit board rey 1 Wy MI Scheduled inspection Unopened repair type Opened repair type replace the power part including transformer Test item 1 2 3 4 5 Opened repair type replace patient circuit board Test item 1 2 3 4 6 7 Measurement equipment SN INSPECTION AND TESTING Device Labeling Normal condition NC 5 Earth Leakage Single Fault condition SFC Normal Patient condition NC Leakage Current Single Fault UA UA LIBF MA LICF uA LIBF UA condition SFC LICF MA UA LICF uA Mains on Applied Part Leakage Date of Calibration p SE AAA GENE SI Max020 Max NC 300uA refer to UL60601 1 NC 500uA refer to IEC60601 1 SFC 1000uA Max CF applied part NC 10pA SFC 50uA BF applied part NC 100uA SFC 500uA Max CF applied part 50uA BF applied part 5000uA
23. e simulator and set the simulator as follows SpO to 96 and PR to 80 bmp 3 Setthe patient type to adult pediatric and neonate respectively Observe the monitor and make sure the displayed SpO and PR value fall in the following range 96 2 Adult pediatric Mindray 80 3 bpm 96 3 Neonate 96 2 Adult pediatric 96 3 Neonate 96 2 Adult pediatric 96 3 Neonate Nellcor 80 3 bpm Masimo 80 3 bpm 4 4 2 NIBP Test 4 4 2 1 Leakage Test NOTE e Perform NIBP leakage test before any other NIBP concerned test and calibration Tools required B NIBP cuff for adult patient B Airtubing B Cylinder Follow this procedure to perform the leakage test 4 4 1 Press to set the patient category to Connect the NIBP cuff to the NIBP connector on the monitor e Apply the cuff to the cylinder as shown below Monitor Cylinder Connector for NIBP cuff Air tubing Cuff 4 Start the monitor Within 10 s after you hear a beep press and hold to enter the maintenance mode 5 Press Ce to enter the NIBP leakage test interface In the PR parameter area code 550 is displayed 6 Press to start leakage test The real time pressure is displayed in the mean pressure area In the process you can press to terminate the current leakage test 7 When the leakage test is completed the cuff releases gas automatically If F is displayed in the error code area it in
24. ear is recommended for NIBP TEMP test Electric safety tests 1 Following any repair or replacement For details refer to Appendix A Electrical Safety Inspection 2 After the monitor drops 3 At least once every two years 1 When first installed or reinstalled Power on test 2 Following any repairs or replacement of any main unit parts 1 When first installed Functional test 2 Whenever a battery is replaced Battery check parens et sal Once per year or if the battery run time reduced significantly 4 2 Visual Inspection Perform an overall inspection on the appearance of the equipment The test is passed if the equipment has no obvious signs of damage Follow these guidelines when inspecting the equipment B Carefully inspect the case display screen buttons and knob for obvious signs of damage B Inspect all external connections for loose connectors bent pins or frayed cables Inspect all connectors on the equipment for loose connectors or bent pins B Make sure that safety labels and data plates on the equipment are clearly legible 4 2 4 3 Power on Test This test is to verify that the equipment can power up correctly This test is passed ifthe equipment starts up by following this procedure 1 Insert the battery in the battery compartment and connect the equipment to the AC mains The AC mains indicator and battery indicator light up o Press the button on the front panel to turn on the e
25. ed 2 Replace the power management board 3 Replace the main board Cable defectiveinsidethe Check the cables connecting the converter module board and corresponding parameter module Module loading p gP succeeds but Parameter module l j Replace the corresponding module parameters do defective not function Converter board defective NO Replace corresponding converter board inside the module 5 3 6 Software Upgrade Problems Possible Cause Troubleshooting Power failure or unintended power off Replace the main board during boot file upgrade Incorrect network Check if the monitor is correctly connected connection with the PC Select the program to be upgraded and corresponding software and then perform upgrade as described in 8 2 Software Upgrade Boot file upgrade fails Program upgrade fails Incorrect upgrade or unmatched program package Battery abnormal after upgrading the power management program Fails to power cycle the monitor after upgrading Upgrade the power management software the power management again and then power cycle the monitor program 5 4 Error codes Error codes are displayed on the monitor if a failure is detected For detailed failure description cause and solutions please refer to Appendix D Error codes in the Operator s Manual FOR YOUR NOTES 6 Disassembly and Repair 6 1 Tools Required To disassemble and replace the parts and components the following tools m
26. ement interface receptacle board Power management 051 001360 00 board service kit with Masimo receptacle Power management board bracket SpO2 shield 047 010576 00 SpO2 board service kit 115 018383 00 9008 V2 0 Nellcor SpO board 5 1 SpO2 board 0671 00 0102 01 MDU SpO2 board Masimo 040 001 149 00 MS 2013 m nr Screw assembly 7 6 Parameter Connector Panel Assembly 7 6 1 Exploded View 7 re 2 Parts List 115 017686 00 ve OO Pane 3 NIBP gas nozzle assembly wo SpO2 assembly 009 003371 00 003371 00 009 003371 00 Mindray 6011 Mindray 6011 SpO2 signal cable 009 003372 00 Masimo 6011 009 003373 00 Nellcor 6011 7 7 7 7 Predictive Temp Assembly 7 7 1 Exploded View 7 7 2 Parts List E NENNEN Screw Pan head Screw Pan head w washer 2 MO9A 30 62080 E Temp module 801 6006 00043 00 power board PCBA ra Temp module insulator Temp module insulator insulator 4 fy FOOL ENDEAVOUR E b 043 003152 00 Predictive Temp housing 043 003152 00 _ g Temp on position detection a 051 001419 00 board PCBA 051 001419 00 7 8 043 003312 00 External compartment for 043 003312 00 Temp module VS 049 000547 00 Temp cover for VS 600 049 000547 00 MO9A 20 62064 20 62064 Silicon buttons buttons MO9A 20 62064 20 62064 051 001435 00 a a BREMS 051 001435 00 PCBA Screw pan head cross recessed M2X6 Temp module sup
27. en the display and main distorted Cable defective board and the backlight cable are correctly connected 5 3 3 Button Failures Possible Cause Troubleshooting Ghbledefedtive Check that the cable between the keypad board oc ono and main board is correctly connected wor Keypad board failure Replace the keypad board 5 3 4 Battery Failures Possible Cause Troubleshooting Battery defective Replace the battery Check that the cable between the battery interface board Cable defective Battery and power management board is correctly connected cannot be charged EU len Replace the power management board g board defective Battery interface l i ry interf rd board defective Replace the battery interface board NOTE e When the battery module has a failure it may cause problems to other components In this case troubleshoot the battery module per the procedure described in the table above Components of the main unit are powered by the power module In the event that a component malfunctions check if the operating voltage is correct 5 2 5 3 5 Module defective Possible Cause Troubleshooting 1 Check that the cable between the external converter board inside the module and the Module defective converter board is correctly connected 2 Replace the converter board Failed to load modules 1 Check that the cable between the main board and power management board is Main unit defective correctly connect
28. er area an means SpO module is configured on this equipment while DRA means the contrary 2 Restart the monitor 8 2 Software Upgrade A download tool is adopted for the upgrade of 6011 products i e Parameter Module Upgrade and Download tool PN G 0010 30 43088 Upgradeable Download Software for VS 600 No fon HN 110 002528 00 Main control function program VS600 110 002525 00 Power management program 110 001842 00 Software for Mindray SpO module NIBP module software LPC2136 TEMP module software New Vital signs NcAUTION e Disconnect the equipment from the patient Do not shut down or power off the equipment during upgrade Otherwise it may cause the equipment to break down e Software upgrade should be performed by qualified service personnel only 8 2 1 Upgrade program installation 1 Runtheinstallation file setup exe on your PC Click Next Enter User name Company and correct CD KEY 36729683225 and then click Next 4 Select the path and click Next 5 Click Finish to finish the installation 8 2 2 Upgrading software 1 Connect PC with monitor s RS232 port with standard serial port extentd cable and remember the COM comber such as COMI 2 Runthe upgrade program on your PC through click Start All Programs Mindray icare upgrade program icare amp Internet Set Program Access and Defaults windows Catalog 3 E mail 5 Out
29. ge nee 8 1 8 1 2 Upgrading Parameter Modules annennenonnenenensenseneveeneeneneenssaansvaeneensveene 8 1 8 1 3 Upgrading Tempus en ee ae ea 8 2 8 1 4 Enabling Parameter Functions an ananonsenoeneneeneuneneensnnensvaenseneveeneveensunevennsnaansvaeneenes 8 2 82 software podrida 8 3 8 2 1 Upgrade program installation eerte esee eeee entere teretes tote nton ccoo 8 3 8 2 2 Upgrading SOWAT E essa nenten erdee 8 3 A Electrical Safety Inspection zu a A 1 PE Power cord lenin A 1 A2 Device Enclosure and Accessories a A 2 A 3 Device Labeling aaa a d E EA e e d temen A 2 Ad Protective Earth RESIS Fall CO Sasso nee A 2 A EarthiEeakage Test aaa en A 4 Asb Patient Feakage Current o sco e dtm bcd ca on e A 5 A 7 Mains on Applied Part Eeakage s te eee e nhi ie EE re A 7 FOR YOUR NOTES 1 Introduction 1 1 Information of This Manual A detailed revision history of this manual is recorded in the table below Version Revision History 1 0 New 1 2 Safety Information NDANGER e Indicates an imminent hazard that if not avoided will result in death or serious injury warnine e Indicates a potential hazard or unsafe practice that if not avoided will result in death or serious injury NcAUTION e Indicates a potential hazard or unsafe practice that if not avoided could result in minor personal injury or product property damage NOTE e Provides application tips or other useful infor
30. he four PT3x8 screws as indicated below Then take out the main bracket assembly Wr self tapping screws 6 4 6 3 5 Removing the Parameter Board SpO Optional and Power Management Board 1 Unscrew the two M3x6 screws and two external hexagon screws and take the power management board assembly out from the main bracket assembly 2 M3 screws m bg Fe A yr 2 external hexagon screws 2 Unscrew the two M3x4 screws and take the parameter board out from the power management board assembly L i p am is Parameter Board fs iS Power management 6 5 6 3 6 Disassembling Pumps and Valves NIBP optional 1 Cut the two cable ties and take out the gas pump p 2 Unscrew the two M3x6 screws as indicated and take out the valve 6 3 7 Disassembling AC DC Power Board and Battery Converter Board 1 Unscrew the four M3x6 screws as indicated and take out the AC DC power board 2 Unscrew the two M3 nuts to take out the battery interface board 6 4 Disassembling the Front Housing Assembly NOTE To disassemble the equipment place the equipment on a work surface free from foreign material avoiding damaging the screen e Remember to install the screen support pad properly during reassembly Operations relating to optional parts may not apply to your equipment 6 4 1 Removing the Main Board Disconnect the cable between the main board and keypad board Unscrew the f
31. l the device defective To Perform the Test 1 Fromthe MAIN MENU or with the outlet unpowered plug the DUT into the 601PRO front panel outlet 2 Attach the 601PRO RED input lead to the device s Protective Earth terminal or an exposed metal area 3 Press shortcut key 3 The Protective Earth Resistance test is displayed 4 Press SOFT KEY 3 to select a test current 1AMP 10AMP or 25AMP The selected test current is displayed in the upper right corner of the display Prot Earth Resistance Test Current 1A A Ohm Limit 0 000 START TEST CAL LEADS AMPERES GLD We Te e 5 Press START TEST to start the test The test current is applied while resistance and current readings are taken This takes approximately 5 seconds 6 Press the print data key at any time to generate a printout of the latest measurement s NOTE e When Over is displayed for Ohms this signifies that a valid measurement was not obtained because either an open connection was detected or that the measurement was not within range Readings greater than 9 999 Ohms will be displayed as Over In Case of Failure Once it reaches the limitation stop using and inform the Customer Service Engineer for analysis and disposal LIMITS ALL COUNTRIES R 0 2 O Maximum A 5 Earth Leakage Test Run an Earth Leakage test on the device being tested before performing any other leakage tests Leakage current is measured the following ways B Earth Leakage Cur
32. look Express Windows Update Mm 7 zip Central Monitoring S a tems A Central Monitoring System Internet Explorer icare mM Games Windows Media Plays Startup amp Internet Explorer MSN wg MSN 2 Outlook Express 3 Windows Messenger x Remote Assistance windows Media Player Tour Windows XP 8 Windows Messenger QW Windows Movie Maker AllPrograms fg Mindray icare upgrade programme gt Ej icare P Log Off Turn Off Computer start BS Master S luhy 3 Choose VS 600 from the poped up menu Pulse Oximeter Type Selection Machine Type ICARE VS bDl Iv Display this dialog box atthe startup 4 Click ok and then enter Password 8593210 in the poped up menu Password Flease enter password Fassword cancel 8 4 5 Click ok VS 600 Update Tool menu pops up Ki VS 600 Update Tool About Help Make package Select Package Package Path Pot Stats Percent Time s Start Start Start Start Start Start Start Start 6 Select package Path Made time Check sum Module Checksum Version Note System program DB 83 72 00 Cancel ER Upgrade package shall be pkg files Select package according to system requirement The package files are made and supplied by our company You do not need to make package by yourself 8 5 4 Click Yes to finsih the package selection
33. mation to ensure that you get the most from your product 1 2 1 Dangers There are no dangers that refer to the product in general Specific Danger statements may be given in the respective sections of this manual 1 1 1 2 2 Warnings NwARNING e Allinstallation operations expansions changes modifications and repairs of this product are conducted by Mindray authorized personnel e There is high voltage inside the equipment Never disassemble the equipment before it is disconnected from the AC power source or the battery e When you disassemble reassemble a parameter module a patient leakage current test must be performed before it is used again for monitoring e The equipment must be connected to a properly installed power outlet with protective earth contacts only If the installation does not provide for a protective earth conductor disconnect it from the power line and operate it on battery power if possible e Disposal of the packaging material should observe the applicable waste control regulations and keeping it out of children s reach 1 2 3 Cautions NcAUTION e Make sure that no electromagnetic radiation interferes with the performance of the equipment when preparing to carry out performance tests Mobile phone X ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation eo Before connecting the receiver to the power line check that the volt
34. neonatal patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians 2 2 Connectors for Peripheral Devices N 100 240V I 50 60Hz f amp IT 7 1 Input Output connect RS 232 connector This connector is used for software upgrade and DIAP communication AC power input Equipotential grounding terminal When the equipment and other devices are to be used together their equipotential grounding terminals should be connected together to eliminate the potential difference between them 2 1 2 3 Main Unit The main unit of the vital signs monitor consists of three parts B Fronthousing assembly consisting of main board segment code display and Power On Off keypad B Rear housing assembly power module AC DC power management and interface board including SpO isolation power battery NIBP module and SpO board including three types of configuration i e Mindray Masimo and Nellcor and B External module Temp module The following figure shows the main unit architecture of the vital signs monitor Rear Housing Assembly r External module Temp module Temp probe External connector Only RS232 port for upgrade screened for end users 2 4 Front Housing Assembly Main Board The
35. ng tne Keypad rennen ua 6 8 6 5 Disassembling the Temp Module Optional a ananoaneunenoenensenensenseneneenenneneeneneen 6 9 6 5 1 Removing the Temp Module PCBA and Temp Module Power Board PCBA 6 9 6 5 2 Disassembling the Temp On Position Detection Board PCBA nnen 6 9 7 4 1 c M 7 1 7 1 ntroduction Pe 7 1 7 2 M albi PE Serre rte eenen eel des 7 1 LANEX poded MEW steh di mb ad EM NA t Ned n 7 1 7 2 Parts Est Rasur Dane 7 2 7 3 Front Housing AssemDIy sei esten atcp etel ee kennen 7 3 Zo Mg mo 0 01019 VIEW METRE 7 3 732 Parte EISE oro ei 7 3 74A Maln Bracket ASSeraDIy seus e a 7 4 TAN Exploded VIGW scii ad AAA 7 4 AZ Parte E nsi tein E ettet be eU SMEs bad aute EUN UR cle t ond 7 5 7 5 Power Management Board Assembly eee senoenonoenoenoensensanensensenseneunensensenseneansen 7 6 Pod EXDIOGGCVIOW ee meer 7 6 ASA A A eier essen 7 6 7 6 Parameter Connector Panel Assembly sssseesssseesssseessseeesssesosseesssseessseesssseesssseesseeeesseesosseeossserosseessss 7 7 TONE OGG LOW avons d a imet eneen ennen 7 7 FO DP ANUS NI p HD 7 1 TI Predictive Temp ASS nntb len 7 8 TAME AA di 7 8 7 1 2 Parts EiS C 7 8 8 Hardware and Software Upgrade essoossssssssssnsnsssssssnsnsnnsssnsnnnnsnnnsnnssnsnsnnnssssnssnsnsnnnssnnnnnne 8 1 Sb Faro Ware Upgrades doc 8 1 8 1 1 Upgrade Packa
36. nnenennenenennenennenennennenennenee 3 1 3 2 2 Environmental Requirements Nena 3 1 3 2 3 Electrica Requirement S ca ro eate i o n a EUR ND qa p qni den 3 2 33 EquipmientinstallatloDs an ede et meo ca RU er eee 3 2 3 4 Preparation Tor POWE ON NS sso Rte e e rn redi danae inde 3 3 A Testing and Maintenance sovisssssssiseciseseserescdscsescsssecssecsceessedeseinieddcecesesssesniedsceccsedesesasecscacesessse 4 1 AM IR TOCAN e EDLER 4 1 411 TESTEQUID MENE ias 4 1 AZ TEST REPO nee ee 4 1 4 1 3 Preventative Maintenance tenen 4 1 41 4 Recommended Frequency ae nd vente ie pierdan Tu er federe adus 4 2 4 7 Visual TINS DEC EIOMA sais ce E E o EE E 4 2 4 3 PowerON MOS m 4 3 44 Module Performance Tests nun osi o 4 3 AMS PO TESSA a 4 3 AAD NIBP A AA 4 4 AAS TEMP Test 4 8 AS Electric safety tests nennen RAT ToS 4 8 4 6 Battery check insofern 4 8 4 7 Maintenance MOTE ie ee 4 9 4 7 1 Entering Quitting Maintenance Mode eese eene teretes tate tnntn tonos 4 9 4 7 2 Checking Version InformatiOn nasansunsenensnssensensensenenaensensensensvaesnensensensenssnevaernenn 4 9 4 7 3 Restoring Factory Default Configuration eee oeneenenseanensenseneenensensensens 4 10 5 Troubleshooting e 5 1 Ee M 5 1 252 Parts Replacement ea csse neede eeen 5 1 5 2 Troubleshooting GUIS seat etenim eati
37. nt Open the package and take out the packing list Check that all the articles included in the packing list are available and the quantity and specification are correct Make sure that B Allthe optional parts purchased by the customer shall also be checked B Notify the supplier if provided components are not correct as compared to the packing list B Incase of damage during transportation keep the packing material and notify the supplier immediately B Keep the packing material till new equipment is accepted 3 2 Preparation for Installation 3 2 1 Preparation for Installation Site 1 Ensure that the site meets all safety environmental and power requirements Check that required power sockets are available Check that a network connector is available if the equipment needs to be connected to network 3 2 2 Environmental Requirements To avoid explosion hazard do not use the equipment in the presence of flammable anesthetics vapors or liquids The environment where the equipment will be used should be reasonably free from vibration dust and corrosive substances If these conditions are not met the system may not function normally The environmental specification is as follows Relative humidity E Temperature C noncondensing Altitude kPa i 0 to 40 without Temp module Operating i j 15 to 9596 57 0 to 107 4 environment 5 to 40 with Temp module storage 30 to 70 10 to 9596 16 0 to 107 4 environment 3
38. odifications to the procedure Follow the instructions of the analyzer manufacturer he electrical safety inspection should be periodically performed every two years The safety analyzer also proves to be an excellent troubleshooting tool to detect abnormalities of line voltage and grounding as well as total current loads A 1 Power Cord Plug A 1 1 The Power Plug The power plug pins No broken or bent pin No discolored pins The plug body No physical damage to the plug body The power plug T No physical damage to the strain relief No The strain relief D plug warmth for device in use No physical damage to the cord No deterioration to the cord For devices with detachable power cords The power cord inspect the connection at the device For devices with non detachable power cords inspect the strain relief at the device A 2 Device Enclosure and Accessories A 2 1 Visual Inspection Test Item Acceptance Criteria No physical damage to the enclosure and accessories No physical damage to meters switches connectors etc The enclosure and accessories No residue of fluid spillage e g water coffee chemicals etc No loose or missing parts e g knobs dials terminals etc A 2 2 Contextual Inspection Test Item Acceptance Criteria No unusual noises e g a rattle inside the case No unusual smells e 9 burning or smoky smells The enclosure and accessories PEX particularly from ventilation holes
39. our M3x6 screws and take out the main board as shown below l4 M3 screws 6 4 2 Removing the Display Unscrew the four M3x8 screws as indicated below Take out the display assembly Then 6 4 3 Removing the Keypad Unscrew the Two PT3x8 screws indicated below and take out the keypad 6 5 Disassembling the Temp Module Optional 6 5 1 Removing the Temp Module PCBA and Temp Module Power Board PCBA Unscrew the 2 M3 screws indicated below and take out the metal sheet Disconnect the Temp board cable and the cable between Temp isolation power board and Temp board Unscrew the four M3x6 screws you can take out the Temp module PCBA Then unscrew the three M3x6 screws you can take out the Temp module power board PCBA Cable between the isolation power board and Temp board Screw for metal sheet emp board cable 4 screws E emp module power EM board PCBA er emp module PCBA 6 5 2 Disassembling the Temp On Position Detection Board PCBA 1 Unscrew the four M3x6 screws as indicated and take out the temp module housing 2 Unscrew the four M2 screws as indicated below and take out the Temp on position detection board PCBA 4 screws emp on position detection board PCBA NOTE Remember to assemble the silicon button for the Temp on position detection switch during reassembly 7 Parts 7 1 Introduction This section contains the exploded views and parts
40. ower management 011 indicates version 01 01 software version 4 7 3 Restoring Factory Default Configuration 1 Enter maintenance mode 2 Press Ce and switch to restore factory default configuration interface In the PR parameter area code 000 is displayed 3 Press to change settings HE indicates that the current settings are restoring to the factory default configuration while DFF means to remain the current setting The default settings are NIBP unit mmHg Temp unit C Patient category Adult Beat sound On Temp position oral Brightness 5 Maintenance and Test Report See the above sections for detailed test procedures and contents Customer name Customer address Servicing person Servicing company Equipment under test EUT Model of EUT SN of EUT Hardware version Software Version Test equipment Test Contents Test Record E Result Pass Fail Visual Inspection The case display screen buttons power cord wall mount and accessories have no obvious signs of damage The external connecting cables are not frayed and the connector pins are not loose and bent The external connectors are not loose or their pins are not bent The safety labels and data plate are clearly legible A S Power on test The power on test is passed The power indicator works correctly and the monitor starts up properly Performance test Measure SpO on a healthy person s finger and a PR val
41. owered plug the DUT into the 601PRO front panel outlet and turn on the device Attach the applied parts to the 601PRO s applied part terminals Press shortcut key 6 The Patient Leakage test is displayed and the test begins immediately Patient Leakage All Earth Outlet Rev Pol Earth No L2 OuA Limit Inv DUT OFF NO EARTH L2 APPLIED PART D EPD a CP ee QN 4 Press APPLIED PART SOFT KEY 4 at any time to select the desired applied part leakage current 5 Modify the configuration of the front panel outlet by pressing the appropriate SOFT KEY on the 601PRO 6 Pressthe print data key at any time to generate a printout of the latest measurement In Case of Failure B Check any broken of the enclosure Replace any defective part B Inspect wiring for bad crimps poor connections or damage B Testthe wall outlet verify it is grounded and is free of other wiring abnormalities Notify the user or owner to correct any deviations As a work around check the other outlets to see if they could be used instead B Change another probe to confirm if the fail is caused by console B Ifthe leakage current measurement tests fail on a new unit and if situation can not be corrected submit a Safety Failure Report to document the system problem Remove unit from operation B Ifallelsefails stop using and inform the Customer Service Engineer for analysis and disposal LIMITS For CF applied parts 10uA in Norm
42. port for VS 600 Screw Flat Head Phillips M3X8 Screw pan head cross recessed M3X6 009 003368 00 gt gt 00 predictive Temp 009 003368 00 board cable VS 900 Cable between the 009 003239 00 Temp module and power 009 003239 00 management board VS 900 Cable between the 009 003240 00 isolation power board and 009 003240 00 Temp board FOR YOUR NOTES 7 10 8 Hardware and Software Upgrade 8 1 Hardware Upgrade The vital signs monitor supports upgrade of NIBP SpO and Temp functions 8 1 1 Upgrade Package Upgrade package Description of upgrade PN of upgrade package package VS 600 Mindray SpO upgrade kit 115 018265 00 SpO VS 600 Masimo SpO upgrade kit 115 018266 00 VS 600 Nellcor SpO upgrade kit 115 018267 00 Note measurement accessories are not included in the above upgrade packages 8 1 2 Upgrading Parameter Modules 8 1 2 1 Upgrading Mindray SpO and Nellcor SpO List of upgrade package B A Mindray SpOz board or Nellcor SpO board and B Aconnector panel assembly of the same SpO board 1 Disassemble the power management board and parameter connector panel assembly as described in 6 3 Disassembling the Main Unit 2 Remove the SpO board from the disassembled power management board assembly as described in 6 3 5Removing the Parameter Board SpO2 Optional and Power Management Board and assemble the SpO board in the upgrade kit 3 Install the power management board assembly
43. quipment The work status indicator lights up inside the Power button The screen lights up The main interface is displayed Now the equipment is correctly started 4 4 Module Performance Tests 4 4 1 SpO Test Test Method 1 Tool required B None Test Procedures 1 Connect SpO sensor for adult to the SpO connector of the monitor Press to set the patient category to Apply the SpO sensor to your ring finger assume that you stay healthy Check the PR reading on the screen and make sure that the displayed SpO is within 95 and 100 Remove the SpO gt sensor from your finger and make sure that an alarm of SpO Sensor Off is triggered Measurement validation The SpO accuracy has been validated in human studies against arterial blood sample reference measured with a CO oximeter Pulse oximeter measurements are statistically distributed and only about two thirds of the measurements can be expected to fall within the specified accuracy compared to CO oximeter measurements NOTE TheSpO simulator can only be used to verify that the pulse oximeter operates properly It cannot be used to verify the accuracy of the pulse oximeter or the SpO sensor To verify the accuracy clinical tests are required Test Method 2 Tool required B SpO simulator Index 2 recommended Test Procedures 1 Connect the SpO sensor to the SpO simulator 2 Selected the model and manufacturer of the SpO module to be tested on th
44. rements are being taken To Perform the Test 1 2 3 4 From the MAIN MENU or with the outlet unpowered plug the DUT into the 601 Attach the applied parts to the 601PRO applied part terminals Attach the red terminal lead to a conductive part on the DUT enclosure Press shortcut key 7 The Mains on Applied Part test is displayed Mains on Applied Part All Earth Outlet Norm Pol Earth L2 Norm uA Hev uA Limit Inv START TEST CAL DUT OFF APPLIED PART Guru Cup a CD WU QC 5 Select the desired outlet configuration and applied part to test using the appropriate SOFT KEYS Press START TEST SOFT KEY 1 to begin the test Press the print data key to generate a printout of the latest measurement NOTE e ifall ofthe applied parts correspond to the instrument type the applied parts will be tied together and one reading will be taken If any of the applied parts differ from the instrument type all applied parts will be tested individually based on the type of applied part This applies to Auto and Step modes only In Case of Failure LIMITS Check any broken of the enclosure Replace any defective part Inspect wiring for bad crimps poor connections or damage Test the wall outlet verify it is grounded and is free of other wiring abnormalities Notify the user or owner to correct any deviations As a work around check the other outlets to see if they could be used instead Change another probe to confirm if th
45. rent leakage current measured through DUT outlet Earth B Earth Leakage Current AP EARTH ALL Applied Parts connected to Earth leakage current measured through DUT outlet Earth There is no need to attach a test lead the 601PRO automatically connects the measuring device internally To Perform the Test 1 Fromthe MAIN MENU or with the outlet unpowered plug the DUT into the 601PRO front panel outlet and turn on the device Attach the device s applied parts to the 601PRO applied part terminals if applicable Press shortcut key 4 The Earth Leakage test appears on the display and the test begins immediately Earth Leakage Outlet Rev Pol No Earth L2 No AP Earth OuA Limit Inv DUT OFF EARTH NO L2 AP EARTH ED quw CV we We CD B SOFTKEY 1 toggles the DUT outlet Polarity from Normal to Off to Reverse B SOFT KEY 2 toggles the DUT outlet from Earth to No Earth B SOFT KEY 3 toggles the DUT outlet from L2 to No L2 A 4 B SOFT KEY 4 toggles the AP to Earth to No AP to Earth 4 Pressthe print data key at any time to generate a printout of the latest measurement In Case of Failure B Check any broken of the enclosure Replace any defective part B Inspect wiring for bad crimps poor connections or damage B Testthe wall outlet verify it is grounded and is free of other wiring abnormalities Notify the user or owner to correct any deviations As a work around check the other outlets to see if they could be used instead
46. then the main unit Carefully route the cables Make sure that the waterproof material is properly applied during reassembling 6 1 6 3 Disassembling the Main Unit NOTE Todisassemble the equipment place the equipment on a work surface free from foreign material avoiding damaging the screen e All the operations should be performed by qualified service personnel only Make sure to put on the insulating gloves during service operations Operations relating to optional parts may not apply to your equipment 6 3 1 Disassembling the Temp Module Optional Lay the monitor on a table as shown below Unscrew the two M3x6 screws pull the Temp module up and disconnect the Temp cable 6 3 2 Separating the Front and Rear Half of the Monitor 1 Laythe monitor on a table as shown below Unscrew the four M3 screws 6 2 2 Stand the monitor and separate the front housing assembly and rear housing assembly with caution Disconnect the cable between the main board and power management board and then take off the front panel NOTE e When reassembling the equipment be sure to check if the front housing waterproof strip is correctly placed 6 3 3 Removing the Parameter Connector Panel Assembly Lay the rear housing assembly on the table disconnect the SpO cable and connector panel connecting tube and then take out the parameter connector panel m GR 6 3 4 Disassembling the Main Bracket Assembly Unscrew t
47. to us for repair If the trouble remains exchange the replacement PCB with the original suspicious PCB and continue troubleshooting as directed in this chapter To obtain information on replacement parts or order them refer to chapter 7 Parts 5 3 Troubleshooting Guide 5 3 1 Power On Off Failure Possible Cause Troubleshooting AC mains not connected Check that AC mains is properly connected or or battery too low battery capacity is sufficient 1 Check that the cable between the keypad board and main board is correctly connected 2 Check that the cable between the power board and power management board is correctly connected The monitor fails to start 3 Check that the cable between the main board and power management board is correctly connected Power board defective Replace the power board Ba un RAI Replace the power management board defective The main board failed Replace the main board 5 1 Cable defective 5 3 2 Display Failures Possible Cause Troubleshooting 1 Check if the cable between the display and main board and the backlight cable are correctly Cable defective connected The display is 2 Check that the cables and connectors are not blank or black damaged Main board defective Replace the main board Display defective Replace the display Replace the main board or upgrade the main board Main board error Images with the upgrade software overlapped or Check if the cable betwe
48. ue is displayed The displayed SpO value is within 95 and 100 NIBP test The difference is within 3 mm when 0 50 or 200 mmHg is set for NIBP accuracy test There is no leakage with NIBP or the manual leakage test result does not exceed 6 mmHg min Temp test The displayed Temp value on the monitor is within 37 0 1 C MA Electric safety tests Refer to Appendix A Electrical Safety Inspection IT Battery Check The monitor can operates correctly from battery power when an AC power failure accidentally occurs The monitor can operate independently on a single battery MEN N Test conclusion Tested by Test date 5 Troubleshooting 5 1 Overview In this chapter equipment problems are listed along with possible causes and recommended corrective actions Refer to the tables to check the monitor identify and eliminate the troubles The troubles we list here are frequently arisen difficulties and the actions we recommend can correct most problems but not all of them For more information on troubleshooting contact our Customer Service Department 5 2 Parts Replacement Printed circuit boards PCBs major parts and components in the monitor are replaceable Once you isolate a PCB you suspect defective follow the instructions in chapter 6 Disassembly and Repair to replace the PCB with a known good one and check that the trouble disappears or the equipment passes all performance tests Defective PCB can be sent
49. y not apply to your product If you have any question please contact our Customer Service Department Observance ofthe manual is a prerequisite for proper equipment maintenance and prevents equipment damage and personnel injury Intended Audience This manual is for biomedical engineers authorized technicians or service representatives responsible for troubleshooting repairing and maintaining the equipment Contents Uus X 1 1 Lal IMFORMALION OF This Manuals esie re asa 1 1 1 2 Safety Information kununu 1 1 ZDNet u 1 1 1 22 WARNINGS nn m ene enen eme A a Md 1 2 1 2 3 CAUTIONS d ete eeen sre dd e dot 1 2 1 24 Mec cm 1 2 ES Bguipraient symbols isse cod oeste ost vet roster tere tere vto du an ag cote brede 1 3 PALIICgSRUESITEIpDUS T G 2 1 DION WA AAA AA AAA AAA AAA CIS 2 1 2 2 Connectors for Peripheral DEVICES cscsessssessessssessssecsesscsesscsssscseeseessseesessesesscsseacseeseessseesesseacseeseesees 2 1 23 Mai UD mr 2 2 ZA FONCHOUS NG ASSembbly ae 2 3 2 5 Rear Housing Assembly as EN Enke 2 4 ZO Externa MOGOUIG edere has eH HR ra dud ma dt Sacs a IR MR I MM NIME 2 5 3 Equipment Installation e 3 1 3 1 Unpacking A A AES 3 1 3 2 Preparation forInstallal Oh ee 3 1 3 2 1 Preparation for Installation Site uunsseeeneesesseseseenenssnennenennennenennennne
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