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SERVICE MANUAL

1. Figure 21 Monitor Disassembly Table 12 Part Descriptions Monitor Assembly Part Codes Descriptions Qty Front case assembly A 1 Rear case assembly B 1 Temperature case assembly C 1 58071 0 Screw 3 x 8 tapping 2 S8070 0 Screw 3 x 8 flat head 3 S8091 0 Screw 3 x 12 3 S8092 0 Screw 3 x 16 2 Before the steps A B and C 1 If Temperature option installed remove 2 tapping screws S8071 0 on the rear of the temperature case Disconnect Temperature wire to separate the temperature case from the rear case Remove 3 flat head screws S8070 0 on the bottom of the monitor Remove 5 screws S8091 0 S8092 0 on the rear case Separate the front case from the rear case D oO gt W N Carefully disconnect all cables running between cases disconnect SMPS wire NIBP cable Printer wire Speaker wire Serial wire and NIBP hose YM1000 Service Manual YM1000 Disassembly Guide Front Case Disassembly A This section describes the items that may be removed on the front case assembly Figure 22 Front Case Disassembly Table 13 Part Descriptions Front Case Assembly Part Codes Descriptions Qty T0024 0 Front case 1 T1000 0 Rubber button vertical 1 T1001 0 Rubber button horizontal 1 Main BD ass y 1 58007 0 Screw 3 x 6 3 A1 Main BD disassembly 1 Remove the marked 3 poi
2. 9 min SpOr HE Figure 7 NIBP Inflation Cycle 28 YM1000 Service Manual YM1000 Service Mode and Demo Mode Total System Runtime Total Runtime displays the number of hours rounded to the nearest hour that the monitor has been operational Note The values of Total Runtime may not be reset but it will be reset to zero when a new Main PCB assembly is installed H DIA 0 min SpO MAP mM i EGE AL Figure 8 Total Runtime Factory Default Reset To reset the monitor operating parameters to the factory default settings press the Mode button until DEFAULT RESET NO is displayed To reset to the factory default values select YES using only Up selection button The monitor immediately resets to the defaults and the confirmation tone sounds To leave the settings unchanged select NO using only Down selection button DIA JL JI spo 00000100 Figure 9 Factory Defaults Reset YM1000 Service Manual 29 Service Mode and Demo Mode YM1000 Factory default settings are described in Table 8 Table 8 Factory Default Settings for YM1000
3. 2 Remove Temperature probe holder from Temperature case YM1000 Service Manual 59 Disassembly Guide YM1000 Figure 31 YM1000 Exploded View 60 YM1000 Service Manual Spare Parts Introduction Obtaining Replacement Parts Parts List WARNING Follow local government ordinances and recycle instructions regarding disposal or recycling of device components including batteries Introduction Spare parts along with part numbers are shown in Table 21 Item No corresponds to the circled callout numbers in Figure 8 Obtaining Replacement Parts Mediana Technical Service provides technical assistance information and replacement parts To obtain replacement parts contact Mediana Refer to parts by the part names and part numbers YM1000 Service Manual 61 Spare Parts YM1000 Parts List Mediana Technical Service provides technical assistance information and replacement parts To obtain replacement parts contact Mediana Refer to parts by part numbers and part names Figure 32 YM1000 Exploded View Spare Parts 62 YM1000 Service Manual YM1000 Spare Parts Table 22 YM1000 Parts List No Part Code Item Cases 1 T0024 2 Front case 2 T0025 0 SpO2 connector box 3 T0026 0 Rear case 4 T0027 0 Handle 5 T0029 0 SMPS holder 6 T0030 0 Temperature
4. Turn the monitor off Press Power button to turn the monitor on again Verify that previously changed alarm limits and settings are saved displayed Press Review button Verify that E23 event is saved displayed Turn the monitor off 0 Press Power button amp NIBP start stop button simultaneously to enter Service mode 1 Set DEFAULT RESET to YES The monitor will return to the factory defaults 12 Turn the monitor off 13 Press Power button to turn the monitor on again 14 Verify that alarm limits and settings of the monitor are set to the factory defaults Refer to Table 8 Factory defaults 15 Press Review button Verify invalid button tone sounds and all events of trend data has been removed YM1000 Service Manual 19 Performance Verification YM1000 Measurement Parameter Operation Tests Pneumatic System Operation 20 These tests verify the functionality of YM1000 pneumatic system eo Place the neonatal cuff with a rigid PVC vessel 5cm diameter Connect the cuff to NIBP cuff hose connector via the neonatal hose Connect the monitor to an AC power source and then press Power button to turn the monitor on Press NIBP start stop button 4 Verify that Systolic blood pressure display indicates an error code E23 and an audible 6 7 8 9 alarm sounds Press the mode button setting mode to change Patient type to Neonatal Return to the mon
5. EU Representative TECNOMED 2000 S L Valencia 25 28012 Madrid Spain Manufacturer Mediana Co Ltd Wonju Medical Industry Park 1650 1 Donghwa ri Munmak eup Wonju si Gangwon do Korea Tel 82 2 542 3375 82 33 742 5407 Fax 82 2 542 7447 82 33 742 5483 YM1000 Service Manual Revised Date 0306 Part Number Revision A7080 0 Printed in Korea Copyright O 2006 Mediana Co Ltd All rights reserved CE 0434 Rx Only Notice This document contains proprietary information that is protected by copyright All Rights Reserved Reproduction adaptation or translation without prior written permission is prohibited except as allowed under the copyright laws Warranty The information contained in this document is subject to change without notice Mediana makes no warranty of any kind with regard to this material including but not limited to the implied warranties or merchantability and fitness for a particular purpose Mediana shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing performance or use of this material Revision History The documentation part number and revision number indicate its current edition The revision number changes when a new edition is printed in accordance with the revision history of the documentation Minor corrections and updates which are incorporated at reprint do not cause the revision number to change Th
6. SpOz III Figure 15 NIBP Pressure Test NIBP Upgrade This menu is used for the software upgrade of NIBP module Call Mediana Technical Service Department for the software if required Refer to the instructions for use for the software upgrade for the detailed information DIA 9 min SpO z d HIR zJ E D Figure 16 NIBP Upgrade 34 YM1000 Service Manual YM1000 Service Mode and Demo Mode Sound Calibration Sound Calibration is used to set a level of sound volume at factory With Sound Calibration selected 1 Press Up selection button 2 Verify that the level 1 of the volume sounds continuously DIA ry Li SpOz HI lt gt U y E E D Figure 17 Sound Calibration Demo Mode The purpose of Demo mode is to show a visual presentation demonstrating how YM1000 monitor works The following procedure is set to Demo mode 1 With the monitor powered off press Power button and Alarm silence button simultaneously 2 The monitor is now set to Demo mode and demonstrates a typical the monitoring display Note No setting changes allowed Note Only beep tones may be off or on by pressing Up Down selection buttons Alarm silence button can be accesse
7. To obtain replacement parts contact Mediana Refer to parts by the part names and part numbers listed in Spare Parts section YM1000 Service Manual 39 Troubleshooting YM1000 Troubleshooting Guide Power 40 Problems with YM1000 are separated into the categories for further troubleshooting instructions Note Taking the recommended actions discussed in this section will correct the majority of problems you will encounter However problems not covered here can be resolved by calling Mediana Technical Services Power problems are related to AC and or Battery as follows If the action requires replacement of the components refer to Disassembly Guide CAUTION Electrical shock hazard Disconnect a power cord from YM1000 before attempting to open or disassemble YM1000 1 Before further troubleshooting of the power problems 1 1 Review customer complaint and determine if it is safe to plug in and turn on YM1000 1 2 Verify that Charging AC in indicator is lit or flashing as a power cord is connected 1 3 Check fuses F1 F2 and F3 located on SMPS If blown replace fuses 1 4 Check the connection of 8 pin wire between Main BD and SMPS 1 5 Check the connection of 5 pin wire between Battery and SMPS 2 When AC power cord is connected to YM1000 Charging AC in indicator on the front panel is not lit 2 1 Check fuses F1 F2 and F3 located on SMPS If blown replace fuses 2 2 Replace 8 pin wire connected betwe
8. equipments Non invasive blood pressure AAMI SP10 2002 A1 2003 Electronic or Automated sphygmomanometers EN1060 1 1995 Non invasive sphygmomanometers EN1060 3 1997 Supplementary requirements for electrical mechanical blood pressure measuring systems IEC60601 2 30 1999 Particular requirements for the safety including essential performance of automatic cycling indirect blood pressure monitoring equipment Oxygen saturation EN865 1997 Pulse oximeters Particular requirements Temperature monitoring E1112 00 Electronic thermometer for intermittent determination of patient temperature 10 YM1000 Service Manual YM1000 Specification Item Compliant with Electromagnetic IEC 60601 1 sub clause 36 IEC Compatibility IEC60601 1 2 2001 A1 2004 Electromagnetic compatibility requirements amp test IEC61000 3 2 2004 Harmonic Emission IEC61000 3 3 2002 Voltage Fluctuations Flicker Emission IEC61000 4 2 2001 Electrostatic Discharge ESD IEC61000 4 3 2002 Radiated RF electromagnetic field IEC61000 4 4 2004 Electrical fast Transient Burst EFT IEC61000 4 5 2001 Surge current IEC61000 4 6 2004 Conducted disturbances induced by RF field IEC61000 4 8 2001 Power frequency 50 60H Magnetic field IEC61000 4 11 2004 Voltage dips short interruptions and voltage variation on power supply input lines CISPR 11 1997 EN55011 1998 RF Emi
9. 3 Error code E49 displays 3 1 Replace SpO2 module Temperature Performance The followings are symptoms and recommended actions to address problems with temperature operational performance If the action requires replacement of a PCB or module refer to Disassembly Guide 1 No displays blank on Temperature display 1 1 Check the connection of 5 pin wire between Temperature PCB and Main BD 1 2 Replace Temperature PCB if problem persists 1 3 Replace Temperature module if problem still persists 1 4 If problem persists after Temperature module replaced replace Main BD 2 Dashes are displaying on Temperature display but no data measured 2 1 Use another temperature probe 2 2 Check the connection of 5 pin wire between Temperature PCB and Main BD 2 3 Replace Temperature PCB if problem persists 2 4 Replace Temperature module if problem still persists 3 Error codes E63 and or E64 often display s 3 1 Use another temperature probe 3 2 Replace Temperature module if problem persists 4 Error code E65 often displays 4 1 Replace Temperature PCB 4 2 Replace Temperature module if problem persists 5 Error code E69 displays 5 1 Replace Temperature module YM1000 Service Manual 43 Troubleshooting YM1000 Printer The followings are symptoms of problems and recommended actions related to printing If the action requires replacement of a PCB or module refer to Disassembly Guide 1 Print settin
10. Configure the electrical safety analyzer as recommended by the electrical analyzer s operating instructions Connect monitor s AC mains power cord to the electrical analyzer as recommended by the electrical analyzer s operating instructions Connect the patient test lead combination in table 6 to the appropriate input connector on the electrical analyzer Turn on YM1000 Perform patient auxiliary current test per table 7 as recommended by electrical analyzer s operating instructions Repeat the patient auxiliary current test for each test lead combination as listed in Table 7 and measure each patient auxiliary current Table 6 Test Lead Combinations First Test Lead Second Test Lead Temperature probe NIBP cuff Temperature probe SpO2 sensor NIBP cuff SpO2 sensor Table 7 Allowable Leakage Current Test Condition Allowable Leakage Current microamps Normal Condition NC 100 SFC Open Supply OS 500 SFC Open Earth SFC OE 500 Normal Condition RM NCRM 100 SFC Open Supply RM SFC OSRM 500 SRC Open Earth RM SFC OERM 500 YM1000 Service Manual Service Mode and Demo Mode Introduction Service Mode Demo Mode Introduction This section describes Service mode that allows authorized personnel to review check system version battery voltage level NIBP inflation cycle total system runtime factory default reset
11. NIBP module 1 4 Replace Main BD if problem persists after NIBP module replaced 2 After NIBP calibration the digit shown in Time display is outside of 040000 070000 2 1 Turn off the monitor 2 2 Go to Service mode Perform NIBP Calibration again see Service Mode section 2 3 If problem persists verify that internal silicon tubing is kinked or disconnected 2 4 Replace NIBP module and pump if problem still persists 3 Often error codes E22 E23 and or E24 display s 3 1 Ensure that an appropriate cuff and hose are used to correspond with Patient type selected 3 2 Go to Service mode Perform NIBP Calibration see Service Mode section 3 3 If problem persists replace NIBP pump 4 Error code E29 displays 4 1 Replace both NIBP module and pump 4 2 If problem persists replace Main BD YM1000 Service Manual YM1000 Troubleshooting SpO2 Performance The followings are symptoms of problems and recommended actions relating to SpO2 operational performance If the action requires replacement of a PCB or module refer to Disassembly Guide 1 No displays blank on SpO2 display 1 1 Replace SpO2 module 1 2 If problem persists replace Main BD 2 Dashes are displaying on SpO2 display but no data measured 2 1 Verify that red LED of SpO2 sensor is on If not replace the SpO2 sensor 2 2 Ensure that the LED intensity increases when opening the SpO2 sensor 2 3 If problem persists replace SpO2 module
12. Overview System Block Diagram MAIN BOARD TEMPERATURE BOARD Button Interface Isolated Area i DC DC SpO Module I Display Driver PC dyb E GA Patient DATA PO Connector e I Slave MCU DATA i g Main MCU Isolated Area Isolated Area DCDC DC DC I Temperature 7 A emperature AK DATA PC i Module i Connector DATA RS232 Driver Patient S IS PC Connector A JPL PC NurseCall lt lt Relay Power Regulators lt x E lt 3 8V 5V a Sound Driver a PC i y PC Serial Connector u JU A 5 b SMES 12V Power Connector NIBP Connector Speaker Printer Connector Battery Charger Connector T ab d NIBP Module Speaker Printer NIBP Pump Figure 33 YM1000 System Block Diagram YM1000 monitor is a multi function the monitor for use on adult pediatric and neonatal patients non invasive blood pressures arterial oxygen saturation pulse rate and temperature YM1000 Service Manual 67 System Processing Description YM1000 In addition to the monitoring and displaying the status of these physiological parameters the instrument performs various microprocessor programmed analyti
13. SpO2 Printer NT Standard Temperature NTP Standard Temperature Printer NST Standard SpO2 Temperature NSTP Standard SpO2 Temperature Printer All information in this manual including the illustrations is based on the monitor configured with Temperature SpO2 and Printer options If your monitor lacks any of these options some information in this manual does not apply Related Documents To perform test and troubleshooting procedures and to understand the principles of operation and circuit analysis sections of this manual you must know how to operate the monitor Refer to YM1000 operator s manual To understand the various blood pressure cuffs SpO2 sensors and temperature probes that work with the monitor refer to the individual directions for use that accompany these accessories Description of the YM1000 monitor The purpose and function of Mediana YM1000 monitor is to monitor noninvasive blood pressure systolic diastolic and mean arterial pressures functional arterial oxygen saturation pulse rate for adult pediatric and neonate patients and temperature for adult and pediatric patients in all hospital areas and hospital type facilities It may be used during hospital transport and in mobile land based environments such as ambulances within the specification of the environmental characteristics Monitor users should be skilled at the level of qualified health care professionals such as a technician doctor nur
14. a full charge discharge cycle to restore normal capacity A full charge of a dead battery takes approximately 12 hours while the monitor is turned off Mediana recommends that YM1000 s sealed lead acid batteries be replaced at 2 year intervals Refer to Disassembly Guide Section CAUTION If YM1000 is to be stored for a period of 2 months or longer it is recommended to notify service personnel to remove the battery from the monitor prior to storage Recharging the battery is strongly recommended when the battery has not been recharged for 2 or more months CAUTION If the battery shows any signs of damage leakage or cracking it must be replaced immediately CAUTION Discarded battery may explode during incineration Recycle used batteries properly Do not dispose of batteries in refuse containers Environmental Protection 14 Follow local governing ordinances and recycling plans regarding disposal or recycling batteries and other device components YM1000 Service Manual Performance Verification Introduction Equipment Needed Performance Tests Safety Tests Introduction This section discusses the tests used to verify performance following repairs or during routine maintenance All tests can be performed without removing YM1000 covers All tests except battery charge and battery performance tests must be performed as the last operation before the monitor is returned to the user If YM1000 fails to perform as specified i
15. about Oximetry theory is specified in SpO2 Processing Temperature Patient block Temperature patient block measures Temperature data interfaced with WelchAllyn Temperature module SureTemp More information about Temperature measurement theory is specified in Temperature Processing YM1000 Service Manual 69 System Processing Description YM1000 NIBP Processing Overview The oscillometric technique does not use Korotkoff sounds to determine blood pressure The oscillometric technique monitors the changes in cuff pressure caused by the flow of blood through the artery The monitor inflates the cuff to a pressure that occludes the artery Even when the artery is occluded the pumping of the heart against the artery can cause small pressure pulses in the cuff baseline pressure The monitor lowers cuff pressure at a controlled rate As the cuff pressure goes down blood starts to flow through the artery The increasing blood flow causes the amplitude of the pressure pulses in the cuff to increase These pressure pulses continue to increase in amplitude with decreasing cuff pressure until they reach a maximum amplitude at which point they begin to decrease with decreasing cuff pressure The cuff pressure at which the pulse amplitude is the greatest is known as Mean Arterial Pressure MAP The manner in which the pulse amplitudes vary is often referred to as the pulse envelope The envelope is an imaginary line that connects the peak of
16. differ in light absorption the amount of red and infrared light absorbed by blood is related to hemoglobin oxygen saturation To identify the oxygen saturation of arterial hemoglobin the monitor uses the pulsatile nature of arterial flow During systole a new pulse of arterial blood enters the vascular bed and blood volume and light absorption increase During diastole blood volume and light absorption reach their lowest point The monitor bases its SpO2 measurements on the difference between maximum and minimum absorption measurements at systole and diastole By doing so it focuses on light absorption by pulsatile arterial blood eliminating the effects of nonpulsatile absorbers such as tissue bone and venous blood Automatic Calibration Because light absorption by hemoglobin is wavelength dependent and because the mean wavelength of LEDs varies an oximeter must know the mean wavelength of the OXIMAX sensor s red LED to accurately measure SpO2 During the monitoring the Instrument e software selects coefficients that are appropriate for the wavelength of that individual sensor s red LED these coefficients are then used to determine SpO2 Additionally to compensate for differences in tissue thickness the light intensity of the sensor s LEDs is adjusted automatically Measured versus Calculated Saturation 72 The measured SpO2 value from an oximeter may differ from the saturation value that is calculated from a blood gas partial
17. each pressure pulse and forms an outline The shape of the envelope is observed by the monitor using a variety of techniques to determine the diastolic and systolic blood pressure Distole e Oscillometric Response Systole Pressure Pulses gt Systole LL MAP _Distole___ ess gt Systole e Cuff Pressure MAP Distole gt TIME Overall Accuracy Discussion 70 Overall system accuracy shall be determined by considering various influences of the pressure sensor accuracy motion artifacts and other artifact created by pressure valve technical errors of electrical components and the origin error of oscillometric method The origin error of oscillometric comes from the basic theory of that the MAP is determined by the pulse Therefore there might be an error of the time between two pulses In another words the greatest amplitude point of pulses could not represent the MAP point exactly YM1000 Service Manual YM1000 System Processing Description On clinical trial perspective overall system accuracy is not easy to be determined The clinical trial test protocols have been tried and have been described in many treatises and international standards So there are many methods to determine the overall system accuracy of Automated Sphygmomanometer using the oscillometric method But there are no absolute test protocols to determine the overall system accuracy of the Automated Sphyg
18. limit adjustment alarm silence function and etc Display Driver Front panel display provides visual patient data and monitor status At power up all indicators are illuminated to allow verification of their proper operation Display consists of END Module END module is integrated with Display Drive IC GM6486 FND module is able to display red amber and or green 7 segments display patient measurement data time and or values Pulse amplitude indicator displays in the format of 8 segments The pulse amplitude indicator illuminates with each pulse beat The number of segments illuminated indicates the relative signal strength of the pulse beat Indicators are also located on the front panel display Indicators are illuminated indicating a function that is active Functions indicated by the Indicators are AC battery status alarm silence patient type NIBP amp temperature unit and print mode Sound Driver Sound frequency generated from Main MCU is transferred to output to the Speaker via LM386 audio amplifier The gain of this amplifier changes sound level of volume as a resistor is adjusted NIBP Patient block NIBP patient block measures NIBP data interfaced with WelchAllyn NIBP module POEM More information about NIBP measurement theory is specified in NIBP Processing SpO Patient block SpO2 patient block measures oxygen saturation data and pulse rate interfaced with Nellcor Oximetry module MP 506 Nell 3 More information
19. night panel NIBP calibration NIBP pressure test and sound calibration in order to obtain service related information about the monitor Also this section explains how to demonstrate the monitor Demo mode Service Mode Follow the procedure below to enter Service mode 1 With the monitor powered off press Power button and NIBP start stop button simultaneously 2 System version displays on the monitor 3 Press Mode button to select a mode item System Version The revision level of the system software displays system software version NIBP module version SpO2 module version and Temperature module version System version H a UU Temperature module version NIBP module version SpO2 module version Figure 5 System Version Note The system version shown above is only a sample YM1000 Service Manual 27 Service Mode and Demo Mode YM1000 Battery Voltage Level Current battery voltage level is displayed unit of voltage V DIA MAP bHE Figure 6 Battery Voltage Level NIBP Inflation Cycle The number of NIBP inflation cycles operated is displayed Note The values of NIBP inflation cycle may not be reset but it will be reset to zero when a new Main PCB assembly is installed
20. no pulse detected E28 Valid BP not found E29 NIBP module error malfunction E41 Sensor off E42 Sensor disconnected E43 Bad sensor E44 Loss of pulse E49 SpO2 module error malfunction Pp Loss of tissue contact E62 Probe disconnected E63 Probe error E64 Probe heated too high E65 Ambient temperature out of range E69 Temperature module error malfunction 46 YM1000 Service Manual Disassembly Guide General Replacement Level Supported Prior to Disassembly Fuse Replacement Battery Replacement Monitor Disassembly D d General WARNING Do not place YM1000 into operation after repair or maintenance until Performance Safety Tests and NIBP Calibration listed in this service manual have been performed Failure of these tests could result in erroneous readings WARNING Electrical shock hazard Disconnect the power cord from YM1000 before attempting to open or disassemble YM1000 CAUTION Observe ESD electrostatic discharge precautions when working within the unit Note Some spare parts have a business reply card attached When you receive these spare parts please fill out and return the card This section describes disassembly procedures detailed disassembly instructions and accompanied by illustrations Disassembly Sequence Flow Chart that is used to access replaceable parts of YM1000 is illustrated in Figure 19 The boxes on the flow chart represent the various components or sub assemb
21. optional printer check a printer s door is closed well Operating error may be caused if the cover is not closed correctly 9 CAUTION If internal battery cable has been disconnected pay particular attention to polarity of the cable before reattaching If battery cable polarity is reversed it is likely that circuit damage will occur CAUTION Ferrite Cores are used for electromagnetic compatibility Please do not remove Ferrite Cores while disassembling or reassembling otherwise the monitor can be affected by electromagnetic interference and measure inaccurate data to be displayed or stored 4 e CAUTION For continued protection against risk of fire replace only with same type and rating of fuse 2 YM1000 Service Manual YM1000 Introduction Manual Overview This manual contains information for servicing YM1000 monitor The monitor subsequently referred to as YM1000 throughout this manual Only qualified service personnel should service this product Before servicing YM1000 read the operator s manual carefully for a thorough understanding of safe operation Read and understand all safety warnings and service notes printed in this service manual and the operator s manual This manual contains information about YM1000 monitor YM1000 monitor includes the following configuration Config Features Config Features N Standard NIBP Pulse Rate NP Standard Printer NS Standard SpO2 NSP Standard
22. range Adult 20 mmHg to 255 mmHg 2 6 kPa to 33 9 kPa Pediatric 15 mmHg to 140 mmHg 1 9 kPa to 18 6 kPa Neonatal 10 mmHg to 110 mmHg 1 3 kPa to 14 6 kPa Pressure Display Accuracy Meets ANSI AAMI SP10 1992 A1 1996 Cuff Pressure Range 0 to 300 mmHg 0 to 40 kPa Initial Cuff Inflation Adult 100 120 140 160 Default 180 200 220 240 270 mmHg 13 3 15 9 18 6 21 2 default 23 9 26 6 29 2 31 9 35 9 kPa Pediatric 80 90 100 110 120 default 130 140 150 160 170 mmHg 10 6 11 9 13 3 14 6 15 9 default 17 2 18 6 19 9 21 2 22 6 kPa Neonatal 50 60 70 80 90 default 100 110 120 132 mmHg 6 6 7 9 9 3 10 6 11 9 default 13 3 14 6 15 9 17 5 kPa Overpressure protector Adult 280 mmHg N C 308 mmHg S F C Pediatric 220 mmHg Neonatal 154 mmHg Standards ANSI AAMI SP10 1992 A1 1996 IEC60601 2 30 1999 EN1060 1 1995 and EN1060 3 1997 Note Systolic and diastolic blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff stethoscope auscultation method within the limits prescribed by the American National Standard Electronic or automated sphygmomanometers 8 YM1000 Service Manual YM1000 Specification SpO2 Pulse Rate Saturation Range 1 to 100 Low Perfusion 0 03 to 20 Accuracy Without Interference Adults 70 to 100 2 digits 1 to 69 u
23. screws S8070 0 and 2 nuts S8097 0 fastening NIBP pump 5 Remove NIBP pump YM1000 Service Manual 55 56 Disassembly Guide YM1000 Figure 27 Rear Case Disassembly Printer Table 18 Part Descriptions Printer Assembly Part Codes Descriptions Qty M4020 0 Printer 1 58090 0 Screw 3 x 8 3 1 58093 0 Screw 3 x 25 0 2 refers to the number of required screws if a print option is not installed in B4 Printer disassembly 1 Remove 1 screw S8090 0 holding on the right top of Printer 2 Remove 2 screws S8090 0 on the front side of Printer If no print option in remove 2 screws S8093 0 on the front side of Printer 3 Open Printer door 4 Pull out Printer to remove from the rear case assembly YM1000 Service Manual YM1000 Disassembly Guide Figure 28 Rear Case Disassembly Speaker Handle etc Table 19 Part Descriptions Speaker Handle etc Assembly Part Codes Descriptions Qty E9007 0 Speaker 1 T0027 0 Handle 1 58066 0 Screw 3 x 5 tapping 2 58096 0 Screw 3 x 25 tapping 2 B5 Speaker disassembly 1 After step B4 remove 2 screws S8066 0 holding Speaker 2 Remove Speaker B6 Handle disassembly 1 Remove 2 screws S8096 0 fastening Handle 2 Push Handle backward to separate from the rear case B7 Serial connector disassembly 1
24. the trim pot R117 on Main BD 2 3 If problem persists replace Main BD 3 Audible tones sound but a level of sound volume does not change even a level is set to 8 3 1 Adjust the trim pot R117 on Main BD 3 2 If problem persists replace Main BD YM1000 Service Manual 41 Troubleshooting YM1000 Buttons The following is a symptom of problems and recommended actions relating to buttons If the action requires replacement of a PCB assembly refer to Disassembly Guide 1 Buttons do not respond and or buttons are operating with pressed 1 1 Replace Rubber button on Main BD 1 2 If problem persists replace Main BD 2 Buttons do respond but no button tones when pressed 2 1 Verify that Sound mode is set to 3 min in service menu 2 2 Ensure that Speaker is damaged to fail 2 3 Check the connection of 2 pin wire between Speaker and Main BD 2 4 Adjust the trim pot R117 on Main BD 2 5 If problem persists replace Main BD NIBP Performance 42 The followings are symptoms of problems and recommended actions relating to NIBP operational performance If the action requires replacement of a PCB or module refer to Disassembly Guide 1 Dashes are flashing on NIBP display 1 1 Go to Service mode Perform NIBP Calibration see Service Mode section 1 2 If NIBP Calibration is not able to perform check the connection of 24 pin ribbon cable between NIBP module and Main BD 1 3 If problem persists replace
25. 7 EEC Battery Declaration Directive 93 86 EEC Battery Disposal Directive 2002 96 EC waste electrical and electronic equipment WEEE 1509001 2000 Quality Management Systems Requirements 15013485 1996 Quality systems Medical devices particular requirements for the application of ISO9001 IEC60601 1 1988 A1 1991 A2 1995 General requirements for safety and essential performance IEC60529 Degree of Protection Provided by Enclosures Water Ingress Testing IPX0 EN540 1993 Clinical investigation of medical devices for human subjects EN ISO14155 1 2003 Clinical investigation of medical devices for human subjects Part 1 General requirement AAMI HE48 1993 Human factors engineering guidelines and preferred practices for the design of medical devices IEC60601 2 49 2001 Particular requirements for the safety of multifunction patient monitoring equipment IEC60601 1 1 2000 Safety requirements for medical electrical systems IEC60601 1 4 2000 Programmable medical systems IEC60601 1 6 2004 Medical electrical equipment Part 1 6 General requirements for safety collateral standard Usability 15014971 2000 Application of risk management to medical devices 1SO10993 1 2003 Biological evaluation of medical devices Part 1 Evaluation and testing Alarms EN475 1995 Electrically Generated alarm signals IEC60601 1 8 2003 Alarm systems requirements tests and guidances in medical electrical
26. Cleaning To clean YM1000 dampen a cloth with a commercial nonabrasive cleaner and wipe the exterior surfaces lightly e CAUTION Do not allow any liquids to come in contact with the power connector or switches or to penetrate connectors or openings in the instrument Note For cuffs sensors and probes follow the cleaning instructions in the directions for use that accompany these accessories Note If liquid is spilled on the monitor clean and dry thoroughly before reuse Note If in doubt about the monitor safety refer the unit to qualified service personnel For surface cleaning follow your institution s procedures or o YM1000 may be surface cleaned by using a soft cloth dampened with either a commercial or nonabrasive cleaner and lightly wiping the top bottom and front surfaces of the monitor lightly Periodic Safety and Functional Checks YM1000 requires no routine service or calibration other than cleaning and battery maintenance The following performance verification tests may be used following repair or during routine maintenance if required by your local institution 1 Inspect the exterior of YM1000 for damage 2 Inspect labels for legibility If the labels are not legible contact Mediana Technical Services Department 3 Verify that the unit performs properly as described in Performance Verification section 4 Perform the electrical safety tests detailed in Performance Verification section If the unit fails t
27. D Y Day Month Year using only Down selection button DIA LU spo MAP dHE E F HUH Figure 12 Date Format Sound Mode You can activate the specific sound as indicated in the following table via Sound Mode With Sound Mode selected select a number between from 1 to 3 using Up or Down selection button The number 1 2 or 3 is corresponded to full mid or mute Table 9 Sound Mode Variety Measur Temp AC Confir Valid power on ement probe in out mation Invalid beep done in out tone button tone 1 full O O O O O O 2 mid x x X O X O 3 mute X x X x X X DIA min m SpO CO ES SR mn Figure 13 Sound Mode 32 YM1000 Service Manual YM1000 Service Mode and Demo Mode Print Speed This menu is intended for factory use only NIBP Calibration NIBP Calibration is used to calibrate NIBP pneumatic pump With NIBP Calibration selected 1 Connect the NIBP adult hose to the monitor 2 Kink the distal end farthest from the monitor 3 Press Up selection button to start calibration 4 The monitor displays ING during the calibration 5 Wait for about 20 seconds to complete 6 Verify that Time display indicates one
28. M SFC OERM 500 Patient Leakage Current 24 This test measures patient leakage current in accordance with IEC60601 1 clause 19 for Class I Type BF equipment Patient leakage current in this test is measured from any individual patient connection to earth power ground 1 N Configure the electrical safety analyzer as recommended by the analyzer operating instructions Connect the monitor s AC mains power cord to the analyzer as recommended by the analyzer operating instructions Apply NIBP cuff wrapped tightly around an appropriate metal cylinder Connect a test cable between the cylinder and an input connector on analyzer Turn on YM1000 Perform the patient leakage current test as recommended by the analyzer operating instructions Repeat the patient leakage current test for SpO2 and temperature patient connections if those options configured using the appropriate test cables Note Patient leakage current is measured under various conditions of the AC mains and protective earth conductor For each condition the measured leakage current must not exceed that indicated in Table 4 Note This test requires a test cable for each patient connector Test cables for NIBP SpO2 and temperature can be configured in a similar manner by wrapping each sensor end individually with aluminum foil filled with conductive gel only enough gel to ensure conductivity Attach a wire to the foil tha
29. OM Port that current Firmware downloading cable connected 10 Click OK 11 Press Power button to turn on the monitor 12 Verify that Network indicator is flashing 13 Choose File gt Load Flash Image 14 Use the browser to select a binary file e g 20040630_VER1 00_MEDIANA BIN 15 Click OK to start downloading YM1000 Service Manual 37 Firmware download YM1000 38 16 After completion of downloading turn off the monitor 17 Disconnect Firmware downloading cable from the monitor and PC 18 Press Power button and NIBP start stop button simultaneously to enter Service mode of the monitor 19 Press Mode button to go to DEFAULT RESET 20 Select DEFAULT RESET YES to reset the monitor to factory defaults 21 Turn off the monitor 22 After a few seconds turn the monitor on 23 Perform the tests specified in Performance Verification section Note Only Mediana provided Firmware download cable must be used Otherwise Main BD may be damaged Note Software versions of OEM boards are not field upgradeable NIBP SpO2 or Temperature module Replace the subsystem board with a higher current version if necessary Note If any problem during Firmware downloading refer to Firmware Download in Troubleshooting section YM1000 Service Manual Troubleshooting Introduction How to Use This Section Who Should Perform Repairs Replacement Level Supported Troubleshooting Guide Introduction This sec
30. Parameter Ranges Defaults Systolic mmHg Neonatal Low 25 to 115 High 30 to 120 50 100 Alarm Limits Pediatric Low 30 to 155 High 35 to 160 75 145 Adult Low 30 to 255 High 35 to 260 75 220 Diastolic Neonatal Low 10 to 100 High 15 to 105 30 70 mmHg Alarm Limits Pediatric Low 15 to 125 High 20 to 130 35 100 Adult Low 20 to 250 High 25 to 255 35 110 MAP mmHg Neonatal Low 10 to 105 High 15 to 110 35 80 Alarm Limits Pediatric Low 15 to 135 High 20 to 140 50 110 Adult Low 20 to 250 High 25 to 255 50 120 PR bpm Neonatal Low 25 to 295 High 30 to 300 100 200 Alarm Limits Pediatric Low 25 to 295 High 30 to 300 50 150 Adult Low 25 to 295 High 30 to 300 50 120 SpO2 Neonatal Low 50 to 98 High 52 to 100 85 98 Alarm Limits Pediatric Low 50 to 98 High 52 to 100 90 100 Adult Low 50 to 98 High 52 to 100 90 100 Patient Type Adult Pediatric Neonatal Adult NIBP Units mmHg kPa mmHg NIBP initial Neonatal 50 60 70 80 90 100 110 120 132 mmHg 90 mmHg cut intlation 6 6 7 9 9 3 10 6 11 9 13 3 14 6 15 9 17 5 kPa 11 9 kPa Pediatric 80 90 100 110 120 130 140 150 160 170 mmHg 120 mmHg 10 6 11 9 13 3 14 6 15 9 17 2 18 6 19 9 21 2 22 6 15 9 kPa kPa Adult 100 120 140 160 180 200 220 240 270 mmHg 160 mmHg 13 3 15 9 18 6 21 2 23 9 26 6 29 2 31 9 35 9 kPa 21 2 kPa NIBP Auto Interval Off STAT 1 2 3 4 5 10 15 30 15 45 60 90 120 240 Temperature Units M
31. Remove 2 nuts fastening Serial connector on the rear case with 5mm box wrench 2 Remove Serial connector B8 GND terminal disassembly 1 After step B2 remove a nut holding GND terminal with 10mm box wrench 2 Remove GND terminal YM1000 Service Manual 57 Disassembly Guide YM1000 Temperature Case Disassembly This section describes the items that may be removed on the temperature case assembly Figure 29 Temperature Case Disassembly Temperature Module Table 20 Part Descriptions Temperature Module Assembly Part Codes Descriptions Qty P1029 0 Temperature BD 1 M0006 0 Temperature module 1 58007 0 Screw 3 x 6 2 58071 0 Screw 3 x8 tapping 4 C1 Temperature module disassembly 1 Remove 2 screws S8007 0 holding Temperature module 2 Remove Temperature module 3 Disconnect Temperature wire 4 Remove 4 screws 88071 0 fastening Temperature BD 5 Remove Temperature BD 58 YM1000 Service Manual YM1000 Disassembly Guide Figure 30 Temperature Case Disassembly Table 21 Part Descriptions Temperature Case Assembly Part Codes Descriptions Qty T0030 0 Temperature case 1 T0031 0 Temperature probe holder 1 58090 0 Screw 3 x 8 2 58002 0 Screw 3 x 8 with washer 1 C2 Temperature case disassembly 1 After step C1 remove 3 screws holding Temperature probe holder
32. an be measured via an oral axillary rectal or skin surface probe A predictive algorithm in conjunction with the thermistor based thermometer is used for fast temperature or monitoring temperature Predictive temperature Thermometers that render a temperature reading before steady state is achieved are classified as predictive thermometers Predictive thermometers reduce the time required for measurement by using algorithms to predict what the temperature would be if the probe were left in place until steady state is achieved Monitor temperature A function or mode of an electronic thermometer used to continuously monitor temperature until it reached the thermal steady state unchanging The thermal steady state is achieved orally in approximately 3 minutes and axillary in approximately five minutes Measuring Principle The YM1000 temperature probe utilizes a negative temperature coefficient NTC thermistor and control circuitry in combination with the temperature module s predictive algorithm to calculate patient temperatures NTC thermistors have a large temperature coefficient of resistance and change in resistance as temperature changes This predictable change in resistance is the basis for predictive thermometry The Oral axillary probe is pre warmed to approximately 34 C 94 F The probe warming process is a closed loop feedback control system incorporating pulse width modulation PWM control The probe warmer circuitr
33. ase to remove 2 Remove Overlay A4 NIBP cuff hose connector disassembly 1 After step Al use a spanner to unfasten NIBP cuff hose connector 2 Remove NIBP cuff hose connector YM1000 Service Manual 53 Disassembly Guide YM1000 Rear Case Disassembly This section describes the items that may be removed on the front case assembly Figure 25 Rear Case Disassembly Battery SMPS Table 16 Part Descriptions Battery SMPS Assembly Part Codes Descriptions Qty M2010 0 SMPS 1 T4108 0 GND bracket 1 T0029 0 SMPS holder 1 M6007 0 Lead acid battery 1 T4107 0 Battery cover 1 58094 0 Screw 3 x 8 small flat head 4 58002 0 Screw 3 x 8 with washer 1 B2 SMPS disassembly 1 Remove 1 screw S8002 0 located on the right top of SMPS 2 Remove a nut holding CND bracket with 10mm box wrench 3 Pull out SMPS and then separate SMPS holder from SMPS 54 YM1000 Service Manual YM1000 Disassembly Guide Figure 26 Rear Case Disassembly NIBP module Table 17 Part Descriptions NIBP Module Assembly Part Codes Descriptions Qty MO0005 0 NIBP module 1 S8007 0 Screw 3 x 6 4 S8070 0 Screw 3 x 8 flat head 2 S8097 0 Nut M3 2 B3 NIBP module disassembly 1 Remove NIBP pump harness from the connector 2 Remove 4 screws S8007 0 holding NIBP module 3 Remove NIBP module 4 Remove 2
34. ble to the monitor 4 Set SpO2 simulator as follows SpO2 of 90 and pulse rate of 60 bpm 5 Verify SpO2 pulse rate values and pulse amplitude indicator correctly display and pulse tone sounds 6 Press the mode button to enter setting mode 7 Press Up selection button to adjust pulse tone volume from 1 to 8 Return to the monitoring screen 8 Verify beeping pulse tone increases 9 Press the mode button to enter setting mode 10 Press Down selection button to adjust pulse tone volume from 8 to 1 Return to the monitoring screen 11 Verify beeping pulse tone decreases 12 Set pulse tone volume to 0 and return to the monitoring screen Verify pulse tone is no longer audible 13 Return pulse tone volume to a comfortable level Alarm Volume Control Connect the monitor to an AC power source Press Power button to turn the monitor on Kink NIBP cuff hose connector of the monitor and then press NIBP start stop button 1 2 3 4 Verify that the monitor E23 displays and sounds audible alarm 5 Press the mode button to enter setting mode 6 Press Up selection button to adjust alarm volume from 1 to 8 Return to the monitoring screen A Verify alarm tone increases CO Press the mode button to enter setting mode NO Press Down selection button to adjust alarm volume from 8 to 1 Return to the monitoring screen 10 Verify alarm tone decreases 11 Return alarm volume t
35. c pressure display After current inflating pressure comes up to the desired target pressure the monitor starts deflating Ensure that air leakage rate displays 10 Verify that air leakage rate is within 6mmHg min YM1000 Service Manual YM1000 Performance Verification NIBP overpressure test 1 Connect the monitor to an AC power source and then press Power button to turn the monitor on 2 Press Mode button Set to Adult patient type and NIBP target pressure 270mmHg 3 Place the adult cuff with a rigid PVC vessel 9cm diameter Connect the cuff and the adult hose to NIBP simulator Then connect the adult hose to the monitor 4 Set NIBP simulator to Pressure relief or Overpressure test mode 5 Press NIBP start stop button of the monitor as simultaneously pressing start button of NIBP simulator NIBP simulator pressurizes the system until the monitor s over pressure relief system activates 6 Verify that peak point displayed on NIBP simulator point of protection pressure is within 300mmHg Also this point of protection pressure may be verified at the moment of the monitor s NIBP valve of relieved NIBP transducer accuracy test 1 Follow the procedure of NIBP air leakage test specified above 2 During the deflation of the cuff pressure verify that the difference is within 3mmHg between monitor s current pressure and simulator s current pressure Pulse Oximetry Operation If SpO2 option installed the fol
36. cal functions O Creating both visual and audible alarm signals when settable limits are violated O Creating and displaying error codes when conditions are detected that would degrade or prevent valid measurements O Creating and reviewing saved data event e Providing input to an optional recorder for printout of data The monitor is essentially a battery powered instrument An internal charging unit is designed to accept only an AC line voltage Unit Description 68 SMPS The YM1000 allows the user to connect the monitor to AC power ranging from 100 volts AC to 240 volts AC AC power enters directly the YM1000 s Power Supply A 2 amp fuse protects both the Line and Neutral lines These user non accessible fuses are located on a fuse socket which is part of the Power Supply located in the YM1000 The YM1000 uses a switch mode power supply SMPS This Power Supply provides the DC power needed to charge the battery and to power the Main Board The output of the transformer varies depending on load and input High frequency noise from the AC line and from the Main Board is filtered before passing through the bridge rectifier The bridge rectifier provides the DC power used in the YM1000 The positive output is 12 volts DC Battery Charger The power supply will charge the battery any time YM1000 is connected to AC power even if the monitor is not turned on The voltage applied to the battery is 7 5 0 3 volts DC Ba
37. case 7 T0031 0 Temperature probe holder Structure Components 8 T8005 0 Front overlay NST 8 T8006 0 Front overlay NSTP 8 T8007 0 Front overlay NS 8 T8008 0 Front overlay NSP 8 T8009 0 Front overlay NT 8 T8010 0 Front overlay NTP 8 T8011 0 Front overlay N 8 T8012 0 Front overlay NP 9 T1000 0 Rubber button vertical 10 T1001 0 Rubber button horizontal 11 T4104 0 NIBP cuff hose connector 12 T1005 0 Rubber foot circular 13 T1006 0 Rubber foot oval 14 T1007 0 Temperature connector cover 15 T4107 0 Battery cover 16 T4003 0 GND terminal 17 T4108 0 GND bracket Electrical Components 18 P1028 2 Main BD 19 P1029 0 Temperature BD 20 M2010 1 SMPS 21 M4019 0 FND module 22 M0005 0 NIBP module 23 M0001 0 SpO2 module 24 M0006 0 Temperature module 25 M4020 0 Printer 26 M6007 0 Lead acid battery 27 E9007 0 Speaker Harness W0107 0 SMPS wire 8 pin W0108 0 Battery wire 5 pin W0109 0 NIBP cable 24 pin YM1000 Service Manual 63 Spare Parts 64 No Part Code Item W0110 0 Serial wire 9 pin W0111 0 Temperature wire 5 pin W0112 0 Printer wire 6 pin Screws Spacers S58007 0 Screw 3 x 6 58090 0 Screw 3 x 8 S58002 0 Screw 3 x 8 with washer 58091 0 Screw 3 x 12 S58092 0 Screw 3 x 16 S58093 0 Screw 3 x 25 S8010 0 Screw 2 5 x 6 flat head S8070 0 Screw 3 x 8 flat head S8094 0 Screw 3 x 8 small fla
38. d in order to demonstrate Alarm silence indicator illuminated Figure 18 Demo Mode Display YM1000 Service Manual 35 Service Mode and Demo Mode This page is intentionally left blank 36 YM1000 Service Manual YM1000 Firmware download Introduction Equipment Needed How to Download Introduction This section is for the purpose of reloading Firmware into the monitor when the possibility of corrupted Firmware exists or updating Firmware with a new system revision system device version Call Mediana Technical Service Department for the latest version of Firmware and utility required Equipment Needed Table 10 lists the equipment required for Firmware download Table 10 Required Equipments for Firmware download Equipment Description Firmware Downloading Cable 9 pin Serial Cable use only Mediana provided Firmware Downloading Software Rabbit Field Utility Personal Computer With Serial Port How to Download 1 Turn off the monitor 2 Connect Firmware downloading cable to the data interface port of the monitor 3 Connect the other side of Firmware downloading cable to a PC 4 Run RFU EXE Rabbit Field Utility on the PC 5 Choose Setup 6 Click on Communication 7 Check Use Serial Connection and Enable Processor Detection 8 Set Baud Rate to 115200 9 Select an appropriate C
39. diana Technical Services Department it is not necessary to return other accessory items with the monitor Pack YM1000 in its original shipping carton If the original carton is not available use a suitable carton with appropriate packing material to protect it during shipping Repacking In Original Carton If available use the original carton and packing materials Pack the monitor as follows 1 Place the monitor and if necessary accessory items in original packaging 2 Place in shipping carton and seal carton with packaging tape 3 Label carton with shipping address return address and RGA number if applicable YM1000 Service Manual 65 Packing For Shipment YM1000 Repacking In a Different Carton 66 If the original carton is not available use the following procedure to pack YM1000 a Place the monitor in a plastic bag N Locate a corrugated cardboard shipping carton with at least 200 pounds per square inch psi bursting strength eo Fill the bottom of the carton with at least 2 inches of packing material S Place the bagged unit on the layer of packing material and fill the box completely with packing material 5 Seal the carton with packing tape 6 Label the carton with the shipping address return address and RGA number if applicable YM1000 Service Manual System Processing Description System Overview NIBP Processing SpO2 Processing Temperature Processing System
40. dition NC 500 SFC Open Supply SFC OS 1000 Normal Condition RM NCRM 500 SFC Open Supply RM SFC OSRM 1000 Note Earth leakage current is measured under various conditions of the AC mains and protective earth conductor For each condition the measured leakage current must not exceed that indicated in Table 2 Note NC normal condition SFC single fault condition RM reverse mains line voltage Enclosure Leakage Current This test is in compliance with IEC60601 1 enclosure leakage current This test is for ungrounded enclosure current measured between enclosure parts and earth The applied voltage for IEC60601 1 the applied voltage is 264 Volts AC at 50 to 60 Hz 1 Connect the monitor AC plug to the electrical safety analyzer as recommended by the analyzer operating instructions 2 Place a 200 cm foil in contact with the instrument case making sure the foil is not in contact with any metal parts of the enclosure that may be grounded YM1000 Service Manual 23 Performance Verification YM1000 3 Measure the leakage current between the foil and earth Note The analyzer leakage current indication must note exceed the values listed in Table 3 Table 3 Enclosure Leakage Current Test Condition Allowable Leakage Current microamps Normal Condition NC 100 SFC Open Supply OS 500 SFC Open Earth SFC OE 500 Normal Condition RM NCRM 100 SFC Open Supply RM SFC OSRM 500 SRC Open Earth R
41. e document part number changes when extensive technical changes are incorporated Contents Figures Tables Introduction 1 Manual Over TEE 3 Related Documenten a A EE 3 Description of the YM1000 monitor en nn ea aan 3 Specification 7 A aaa aa aaa RA 7 JANETE n t E i EAEE RA de dai Bebe Aa 7 Erivironmenta less ana ee ee Eeer ya Measurement Parameters a aida 8 Ba Seet II A A sion eet 10 Routine Maintenance 13 VT RN 13 Periodic Safety and Functional Check ue 13 Foot hees Eet eege A A A AMAN A TE MO a SE an 14 BAS A Ae EES e Eege ege EE hee 14 Environmental Protect Ons mina Di EEA E EE A aa ta aa db 14 Performance Verification 15 INTO UC NEE 15 Equipment Needed a kanan iia Baten in do ii EEN 15 Performance Tesis ti A EE bok as A EE 16 Safety TS A Ee ee 23 Service Mode and Demo Mode 27 fake eeh tt EE EE 27 Service Modena cita a a idol Ae TAR AKA 27 Demo MOE A EE 35 Firmware download 37 INTO te ITO a A A A A a A a ee Ye 37 te ene EE 37 HOODIA Saa 37 Troubleshooting 39 Introduction Ina D en 39 Howto Use Sen Aa nad Ba E RN 39 Who Should Perform Repair nn nana a AA AAA AA ai 39 Replacement Level Supported EEN 39 Troubleshooting Guide ee 40 Disassembly Guide 47 CO ap RT OST I SOO SN A DANA O a 47 Replacement Level Supported EEN 48 Prior to Disassembly eeschte edel EE atte 49 ERC AAA Ee 49 Battery Replacements ici di IE dd di 49 Monitor Disassembly sni nn Gegend edd 50 Spare Parts 61 troduction aid A A A
42. e rate of 150 bpm Press NIBP start stop button C On Verify following the monitor reaction after measurement completes a The monitor displays NIBP and pulse rate as specified by the simulator b Audible alarm sounds and Pulse rate display flashes indicating the parameter has violated default alarm limits N Press Alarm silence button on the front panel of the monitor CO Verify the following a An audible alarm is temporarily silenced b Pulse rate display continues flashing c Alarm silence indicator is lit d Audible alarm returns in approximately 90 seconds 9 Set NIBP simulator as follows Systolic of 120mmHg Diastolic of 80mmHg and pulse rate of 80 bpm 10 Press NIBP start stop button 11 Verify following the monitor reaction after measurement completes a The monitor displays NIBP and pulse rate as specified by the simulator b The alarm is terminated 12 Disconnect NIBP simulator from the monitor 13 Kink NIBP cuff hose connector of monitor and then press NIBP start stop button 14 Verify that the monitor displays an error code E23 and sounds audible alarm 15 Press Alarm silence button 16 Verify that the alarm is terminated YM1000 Service Manual 17 Performance Verification YM1000 Pulse Tone Volume Control 1 Connect the monitor to an AC power source 2 Press Power button to turn the monitor on 3 Connect SpO2 simulator to the pulse oximetry cable and connect the ca
43. ection of 8 pin wire between SMPS and Main BD 3 2 Check the connection of 5 pin wire between SMPS and Battery 3 3 Ensure that Battery is fully charged 3 4 Replace Battery if problem persists 3 5 Replace Main BD if problem persists after Battery replaced 4 Settings and or measured data are not saved in the memory of the monitor 4 1 Replace Main BD 5 Time display is not updated and or does not indicate current time 5 1 Replace Lithium battery BT1 on Main BD 5 2 Replace Main BD if problem persists 6 Error code E09 often displays 6 1 Replace both SMPS and Main BD YM1000 Service Manual 45 Troubleshooting YM1000 Error Codes When YM1000 detects an error condition the monitor will attempt to show an error code on the display screen If such an error occurs during the monitoring operation the monitor will sound a low priority alarm Audible alarm can be terminated if the alarm silence button pressed but it depends on error codes and conditions Table 11 provides a complete list of error codes and problem identification Table 11 Technical Error Codes Error Codes Description E01 Battery failure E02 Abnormally shutdown last time E09 System error malfunction E21 Air leakage E22 Cuff not detected E23 Kinked or neonate hose E24 Cuff too large for neonate E25 Overpressure condition E26 Motion artifact E27 Weak pulse or
44. en Main BD and SMPS 2 3 Replace Main BD if problem persists 2 4 Replace SMPS if problem persists after Main BD replaced 2 5 Replace END module if problem still persists 3 YM1000 fails to power up when Power button is pressed 3 1 Check on action 1 2 to 1 5 3 2 Download Firmware see Firmware download section 3 3 Replace 8 pin wire of Main BD connected to SMPS if problem persists 3 4 Replace Main BD if problem persists 3 5 Replace Rubber button 3 6 Replace SMPS if problem persists 4 YM1000 is operating on AC main but not operating on Battery 4 1 Check on action 1 2 to 1 5 4 2 The battery may be discharged To recharge the battery connect a power cord to AC mains over 12 hours refer to Battery charge in Performance Verification section Note The monitor may be used with a less than fully charged battery but with a corresponding decrease in operating time from that charge The battery may be defective 4 3 Replace Battery if problem persists after fully charged 4 4 Replace SMPS if problem persists after Battery replaced YM1000 Service Manual YM1000 Troubleshooting Display The followings are symptoms of problems relating to non functioning displays and recommended actions If the action requires replacement of a PCB assembly or module refer to Disassembly Guide 1 Display is totally black no data is visible after system powers up 1 1 Replace Main BD 1 2 Replace FND module 2 Not all disp
45. g EXAMPLE Agreement between test and reference methods for systolic pressure Hypothetical data YM1000 Service Manual 71 System Processing Description YM1000 SpO Processing Overview Pulse oximetry works by applying a sensor to a pulsating arteriolar vascular bed The sensor contains a dual light source and photodetector Bone tissue pigmentation and venous vessels normally absorb a constant amount of light over time The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole as blood volume increases and decreases The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement SpO2 Because a measurement of SpO2 is dependent upon light from the sensor excessive ambient light can interfere with this measurement Pulse oximetry is based on two principles that oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light spectrophotometry and that the volume of arterial blood in tissue and hence light absorption by that blood changes during the pulse plethysmography The monitor determines SpO2 by passing red and infrared light into an arteriolar bed and measuring changes in light absorption during the pulsatile cycle Red and infrared low voltage light emitting diodes LED in the oximetry OXIMAX sensor serve as light sources a photo diode serves as the photo detector Because oxyhemoglobin and deoxyhemoglobin
46. g indicator does not light after system powers up 1 1 Check the connection of 6 pin wire between Printer and Main BD 1 2 Replace Printer 1 3 Replace Main BD if problem persists after Printer replaced 2 Print setting indicator is lit but no printing after Print button pressed 2 1 Ensure that Printer door is properly closed 2 2 Check if Printer paper runs out 2 3 Ensure that Printer paper is placed appropriately 2 4 Check the connection of 6 pin wire between Printer and Main BD 2 5 Replace Printer if problem still persists Firmware download The followings are symptoms and recommended actions to address problems with firmware download If the action requires replacement of a PCB refer to Disassembly Guide 1 Network indicator is not flashing with the pressure of Power button after Firmware downloading cable connected 1 1 Check on action 1 2 to 1 5 of Power troubleshooting page 1 2 Ensure that Mediana Firmware downloading cable is connected 1 3 Ensure that Firmware downloading cable is properly connected to the data interface port of the monitor Also ensure that the other side of Firmware downloading cable is well connected to a PC 1 4 Check the connection of 9 pin serial wire of the monitor inside 1 5 Replace Main BD if problem persists 2 Network indicator is flashing but Firmware download up date fails 2 1 Ensure that COM port of Field utility is properly set 2 2 Verify that COM port of a PC
47. hat Temperature display indicates YM1000 Service Manual YM1000 Performance Verification Safety Tests YM1000 safety tests meet the standards of and are performed in accordance with IEC60601 1 Clause 19 Second Edition 1988 Amendment 1 1991 11 Amendment 2 1995 03 for instruments classified as Class I Type BF Protective Earth Continuity This test checks the integrity of the power cord ground wire from the AC plug to the instrument chassis ground The current used for this test is less than or equal to 4 Volts RMS 50 to 60 Hz and 25 Amperes 1 Connect the monitor AC mains plug to the analyzer as recommended by the analyzer operating instructions 2 Connect the analyzer resistance input lead to the equipotential terminal ground lug on the rear of the instrument Verify that the analyzer indicates 100 milliohms or less Electrical Leakage Earth Leakage Current This test is in compliance with IEC60601 1 earth leakage current The applied voltage for IEC60601 1 the voltage is 264 Volts AC 50 to 60 Hz All measurements shall be made with the power switch in both On and Off positions 1 Connect the monitor AC plug to the electrical safety analyzer as recommended by the analyzer operating instructions 2 Perform test as recommended by analyzer operating instructions Table 2 Earth Leakage Current Values Test Condition Allowable Leakage Current microamps Normal Con
48. hese electrical safety tests do not attempt to repair Contact Mediana Technical Services Department YM1000 Service Manual 13 Routine Maintenance YM1000 Functional Checks Batteries The following checks should be performed at least every 2 years by a qualified service technician 1 If the monitor has been visibly damaged or subjected to mechanical shock for example if dropped perform the performance tests as described in Performance Verification section 2 Perform the electrical safety tests as described in Safety Tests section If the unit fails these electrical safety tests refer to Troubleshooting section 3 Inspect the fuses for proper value and rating qty 2 2 0 A 250 volts for AC mains L N F1 F2 qty 1 6 3 A 250 volts for internal battery LIN F3 If YM1000 has not been used for a long period of time more than 2 months the battery will need charging To charge the battery connect YM1000 to an AC outlet as described in Performance Verification section of this service manual or the Battery Operation section of the operator s manual Mediana recommends replacing the instrument s battery every 2 years When YM1000 is going to be stored for 2 months or more it is recommended to remove the battery prior to storage To replace or remove the battery refer to Disassembly Guide Note Storing YM1000 for a long period without charging the battery may degrade the battery capacity The battery may require
49. id a anna A 61 Obtaining Replacement Parts 61 Parts E EE 62 Packing For Shipment 65 EE EH te EE 65 Returning the YMI000 nit EEN 65 Repacking In Original Carton inn Lan aa dh AAA MAA A a caceres 65 Repacking In a Different Carton c ccccccccscsseseesesesssnsnesescseececeeesenssesesesesnenenenesesesnansnenssssssceceeensseneneseseananens 66 Contents YM1000 System Processing Description 67 KEE 67 NIBP Processing A A 70 LEE 72 Temp rature Pres aaan AE E EEEE EE TEE E ASEE EN sesso 74 Figures Figured YM1000 F ront EE 4 Figure 2 YMI 000 Rear Panen AREA E OR TOUTI TRAE TAOTO EEEO ERTO EEOAE 3 Figure 3 YMIOOO LefeSide Panel A A Geceaaevedeaeetedstacsiverdnsn udusnavesshad vededtaiiesvecest edesalsivatettededveaiusdebes 6 Figure EE 6 Figure EN E 27 Elgure 67 Battery Voltage Levels EA SEA AA ATA AAA EEE AA a ied 28 Figure Z NIBP Inflation ts 28 TEE 29 Figure 9 Factory Defaults Reset sicicsiscavverectecgsenqnestsevdonersecesatitarevencienspasvenrdesdeienseaipsensosatinerpadesuaiveresenesautvessenessueesapethdecarienaonovenesenevienceensianlosontve ease 29 ere PONET ooa EE R EO EEN 31 Figure Tie EE 31 a 32 Figure IL EE 32 Figure e ER Figure EE 34 Figure 16 NIBP UO De lee deed EEN deed ENEE dE ee dE 34 Figure TES QUA e 35 Figure 18 Demo Mode egene ee 35 Figure 19 Disassembly Sequence FLOW Cherokee EENEG aia AANS andate S 48 Figure 20 Battery Disossembl 49 Figure 21 Monitor Disassemb
50. imulator to the monitor Set NIBP simulator SYS of 120mmHg DIA of 80mmHg PR of 80 bpm Set NIBP Auto interval of the monitor to 15 minutes ES 5 After more than 2 hours of the monitor operating verify an audible alarm is sounding and the battery level of the monitor is under 5 4V 6 Allow the monitor to operate until it automatically powers down due to low battery condition Verify that high priority alarm occurs 5 seconds before the monitor automatically shuts down 7 If the monitor passes this test immediately recharge battery YM1000 Service Manual YM1000 Performance Verification Power On Self Test 1 Connect the monitor to AC power source and verify Charging AC in indicator is lit 2 Observe the monitor front panel With the monitor off press Power button The monitor must perform the following sequence a All FNDs and indicators are illuminated b Power on beeps sounds consecutively c Upon successful completion of power on self test the display will enter the normal mode Note Power on self test takes approximately 7 seconds to complete Note If an error code is displayed please refer to Troubleshooting section General Operation Tests Alarms and Alarm Silence 1 Connect the monitor to an AC power source 2 Press the monitor Power button to turn the monitor on 3 Connect NIBP simulator to the monitor 4 Set NIBP simulator as follows Systolic of 120mmHg Diastolic of 80mmHg and puls
51. itoring screen Press NIBP start stop button Verify that the monitor inflates Press NIBP start stop button Verify that the monitor deflates Place the adult cuff with a rigid PVC vessel 9cm diameter Connect the cuff to NIBP cuff hose connector via the adult hose Press NIBP start stop button 10 Verify that Systolic blood pressure display indicates an error code E22 or E24 and an audible alarm sounds 11 Press the mode button setting mode to change Patient type to Adult Return to the monitoring screen 12 Press NIBP start stop button Verify that the monitor inflates 13 Press NIBP start stop button Verify that the monitor deflates NIBP air leakage test Ae UN Connect the monitor to an AC power source Press Power button and NIBP start stop button to enter Service mode Select NIBP Pressure Test by pressing Mode button see figure 12 Set a desired target pressure between 50and 300mmHg by pressing Up Down selection buttons Place the adult cuff with a rigid PVC vessel 9cm diameter Connect the cuff and the adult hose to NIBP simulator Then connect the adult hose to the monitor 6 Set NIBP simulator to Pressure test or Leakage test mode 7 Select the set point of NIBP simulator as the same point of target pressure of the monitor Press NIBP start stop button of the monitor as simultaneously pressing start button of NIBP simulator Current pressure appears on the diastoli
52. lay segments light during POST 2 1 Verify that Main BD connector is properly connected to FND module 2 2 Replace FND module if problem persists 2 3 If problem persists replace Main BD after FND module replaced 3 Values are erratically displayed after system powers up 3 1 Verify that Main BD connector is properly connected to FND module 3 2 Replace FND module if problem persists 3 3 If problem persists replace Main BD after FND module replaced 4 No visual alarm displayed during alarm condition 4 1 Ensure that alarm limits are properly set 4 2 Ensure that patient type is correctly set 4 3 Ensure that patient measurement cables are properly connected and placed 4 4 Replace Main BD if problem persists 4 5 Replace acquisition modules NIBP SpO2 or Temperature if problem persists Sound The followings are symptoms of problems and recommended actions relating to sound If the action requires replacement of a PCB assembly or module refer to Disassembly Guide 1 Audible tones do not sound after system powers up 1 1 Verify that Sound mode is set to 3 min in the service menu 1 2 Verify that Speaker is working properly If necessary replace Speaker 1 3 Check the connection of 2 pin wire between Speaker and Main BD 1 4 If problem persists replace Main BD 2 Sound volume is too low to be heard 2 1 Check if a level of volume is set to minimum value Refer to page 30 31 in the operator s manual 2 2 Adjust
53. lies A complete listing of the available spare parts and part numbers is in Spare Parts section Follow the reverse sequence of the disassembly procedures for reassembly YM1000 can be disassembled down to all major component parts including PCB assemblies acquisition modules FND module Printer SMPS Battery Speaker cables amp wires brackets amp cases The following tools are required small Phillips head screwdriver medium Phillips head screwdriver 5mm Box wrench 10mm Box wrench 0 35inch Spanner needle nose pliers YM1000 Service Manual 47 Disassembly Guide YM1000 YM1000 A B Cc Front Case Rear Case Temperature Case A1 Main Board B1 Battery Cover C1 Temperature Board A1 1 pm em Rubber Button Battery Temperature Module A1 2 SpO2 Module B2 SMPS C2 Temperature Pod A1 3 B2 1 FND Module SMPS Holder B2 2 A2 SpO2 Connector Box GND Bracket A3 Overlay B3 NIBP Module B3 1 A4 NIBP Hose Connector NIBP Pump B4 Printer B5 Speaker B6 Handle B7 Serial Connector B8 GND Terminal Figure 19 Disassembly Sequence Flow Chart Replacement Level Supported 48 The replacement level supported for this p
54. lowing test procedures will verify SpO2 performance p Connect the monitor to an AC power source N Turn on the monitor by pressing Power button W Connect SpO2 simulator to the pulse oximetry cable and connect the cable to the monitor E Set SpO2 simulator as follows SpO2 of 75 and pulse rate of 60 bpm Wu The monitor will sound an audible alarm display an SpO2 of 75 2 digits flashing display a pulse rate of 60 3 bpm display Pulse amplitude indicator 6 Disconnect the pulse oximetry cable from the monitor 7 Verify that the monitor displays an error code E42 and sounds audible alarm YM1000 Service Manual 21 Performance Verification YM1000 Temperature Operation 22 If Temperature option installed the following test procedures will verify temperature performance DD OF WO Ne N Connect the monitor to an AC power source Press Power button to turn the monitor on Connect temperature probe to the temperature connector of the monitor Set Temperature tester to 96 4 F Press the mode button setting mode to select F M monitored mode Insert the temperature probe into of Temperature tester when Ready indicator of the test is on After 3 minutes verify that the monitor displays 96 1 F 96 7 F Measurement accuracy 0 2 F Temperature tester accuracy 0 1 F 8 Return the probe into the probe holder 9 Verify t
55. ly 50 Figure 22 Front Case Disassembly 51 Figure 23 Main BD SpO2 END modules Disassembly 52 Figure 24 Front Case Disassembly Overlay NIBP cuff hose connector Figure 25 Rear Case Disassembly Battery SMPS Figure 26 Rear Case Disassembly NIBP module Figure 27 Rear Case Disassembly Priuter 56 Figure 28 Rear Case Disassembly Speaker Handle etc oF Figure 29 Temperature Case Disassembly Temperature Module Figure 30 Temperature Case Disassembly 59 Figure 31 YM1000 Exploded View 60 Figure 32 YM1000 Exploded View Spare Parts 62 Figure 33 YM1000 System Block Diogrom NENNEN 67 Tables Table 1 Required Test Equipments minivan iia aida a Maa E E Table 2 Earth Leakage Current Values gt Table 3 Enclosure Leakage e Tablet Patient Leakage e ii 24 Table 5 Patient Leakage Current Values Mains Voltage on Applied Part NENNEN 25 Table 6 Test Lead Combinations iso Bevisen in a E Eege Eeer 26 Table EE 26 Table 8 Factory Default Settings for YM1000 NENNEN 30 EE 32 Table 10 Required Equipments for Firmware download 37 Table IL TechnicaliEFror Codes otitis taa aio ed ein aaa Lisette da AER AN ROA tees AAN Ada N 46 Table12 Part Descriptlons Monttor Assembly A AA A A AA EA 50 Table 13 Part Descriptions Front Case Assembly io daa dada a Aa A 51 Table 14 Part Descripti
56. momanometer using oscillometric method Normally the Gold standards of Blood pressure for the reference are the intra arterial pressure and the auscultatory method The popular standard for the overall system accuracy is AAMI SP 10 1992 1996 Electronic or automated sphygmomanometers The main test conditions are as follow A Data comparing the Intra arterial or the auscultatory by the clinical experts with the automated sphygmomanometer B For data collection and the data analysis Bland Altman Plot is used C On the systolic diastolic and MAP the Deltas of all measurements shall be met under 5mmHg of mean difference MD and 8mmHg of standard deviation SD Delta Intra arterial or Auscultatory Automated sphygmomanometer SYSTOLIC PRESSURE Mean difference MD 0 mmHg 20 Standard deviation SD 6 mmHg Se P CS E 15 ou E e O f o 0 O gt mean 2 SD D 1 0 EY W s O O S O gt Bie PG Os 9 oO OO A O EH E O L o o 5 Oy a O Ox DN O GO O D wat s O OO Oo E D SAG LA OS pe 2 S SOOO S O 08 Don 8 cp C90 D OF o 200 Ya O oe 2 D 0 3 Os a OA O mean on Oe ma A OO U Qo z 3 A XD ro O V ooo C 8 O A 7 Y O D 5 Y cx 2 LJ OC O 4 x eS T er y D Qa O O oO O L 2 o Kc O ZS o ra z 10 O O OO O H Kr Q Sp ER S AO mean 2 SD O Or O Q 5 Y 0 o 8 5 15 ES a 20 100 120 140 160 180 200 Average of test and reference methods mmH
57. n any test repairs must be made to correct the problem before the monitor is returned to the user Equipment Needed Table 1 lists the equipment required for performance verification Table 1 Required Test Equipments Equipment Description Digital Multi Meter DMM Fluke Model 87 or Equivalent NIBP Cuff Durable Adult 11cm NIBP Cuff Durable Neonatal 5cm NIBP Hose Adult 8 feet NIBP Hose Neonatal 6 feet NIBP Rigid PVC Vessel 9cm diameter NIBP Rigid PVC Vessel 5cm diameter SpO2 Sensor Extension Cable DOC 10 Temperature Probe Oral Probe NIBP Simulator Bio Tek BP Pump 2 or Equivalent SpO2 Simulator NELLCOR SRC MAX Temperature Simulator WelchAllyn 9600 Calibration Tester Safety Analyzer METRON QA 90 or Equivalent Stopwatch Manual or electronic YM1000 Service Manual 15 Performance Verification YM1000 Performance Tests Power The battery charge and battery performance test should be performed before the monitor repairs whenever the battery is suspected as being a source of the problems All other tests may be used following repairs or during routine maintenance if required by your local institution Before performing the battery performance test ensure that the battery is fully charged This section is written using factory defaults set as power up If your institution has preconfigured custom defaults those values
58. ne Alarm Volume Setting Indicators 27 Time Display 14 Review Button 28 Review Indicator Figure 1 YM1000 Front Panel 4 YM1000 Service Manual YM1000 Introduction a ma ee ifn a e Le TE AC IN 100 240V 50 60 Hz MP 28 38VA 3 4 5 6 1 Handle 4 Equipotential Ground 2 Air Ventilator 5 Battery Cover Replacement 3 AC Power Connector 6 RS 232 Data Interface Figure 2 YM1000 Rear Panel YM1000 Service Manual 5 Introduction YM1000 1 Printer 3 NIBP hose connector 2 SpO2 sensor cable connector Figure 3 YM1000 Left Side Panel 2 3 4 1 Temperature probe 3 Probe holder 2 Probe cover 4 Temperature probe connector Figure 4 YM1000 Right Side Panel 6 YM1000 Service Manual Specification Physical Electrical Environmental Measurement Parameters Compliance Physical Instrument Dimensions 130x180x278 mm Weight 2 7 kg Electrical AC Power Power 100Vac to 240Vac 50 Hz 60 Hz 28 to 38 VA Battery Type Lead acid Voltage Capacity 6 V 4 Ampere Hours Recharge 12 hours with YM1000 Shelf Life 2 years new fully charged battery Complies with 91 157 EEC Environmental Operation Temperature 10 C 50 F to 40 C 104 F Exemption thermometry module operating temperature 16 C 60 F to 40 C 104 F Humidity 15 RH to 95 RH non condensing Altitude 170 m 557 f
59. nspecified Without Interference Neonate 70 to 100 3 digits 1 to 69 unspecified Low Perfusion2 70 to 100 2 digits 1 to 69 unspecified Pulse Rate Range 20 BPM to 300 BPM Accuracy Without Interference 20 BPM to 300 BPM 3 digits Low Perfusion 20 BPM to 300 BPM 3 digits Standards EN865 1997 INeonate specifications are shown for neonate sensors with YM1000 Saturation accuracy will vary by sensor type recommended by the manufacturer 2Specification applies to monitor performance and was validated with Biotek and Nellcor simulators Temperature Probe Type Thermistor probe Range 26 C to 43 C 80 F to 110 F Display Accuracy 0 1 C 0 2 E Measurement units aC PE Measurement modes Predictive Monitored Predictive Mode One time measurement in a single temperature reading which is displayed at the end of the brief measurement period Monitored Mode Continuous measurement over an indefinite period Standards ASTM E1112 00 EN12470 3 Printer Type Thermal Resolution 8 dots mm Printing speed 45 mm s Paper width 57 mm YM1000 Service Manual 9 Specification YM1000 Compliance Item Compliant with Classification Class I on AC power Internally powered on battery power Type of protection Type BF Applied part General Safety 93 42 EEC Medical Device Directive 21CFS820 Code of Federal Regulations 91 15
60. nt screw 58007 0 on the Main BD 2 Separate Main BD from the front case assembly A1 1 Rubber Button disassembly 1 After step A1 remove 2 rubber buttons T1000 0 T1001 0 from Main BD YM1000 Service Manual 51 Disassembly Guide YM1000 52 Figure 23 Main BD SpOz FND modules Disassembly Table 14 Part Descriptions Main BD SpO2 FND Modules Assembly Part Codes Descriptions Qty M4019 0 FND module 1 T0025 0 SpO2 connector box 1 P1028 0 Main BD 1 MO0001 0 SpO2 module 1 S8007 0 Screw 3 x 6 8 S8010 0 Screw 2 5 x 6 flat head 2 A1 2 SpO2 module disassembly 1 After step A1 remove 3 screws 88007 0 holding SpO2 module 2 Remove SpO2 module A1 3 END module disassembly 1 After step A1 remove 5 screws S8007 0 holding END module 2 Remove FND module A2 SpO2 connector box disassembly 1 After step A1 remove 2 flat head screws S8010 0 2 Remove SpO2 connector box YM1000 Service Manual YM1000 Disassembly Guide Figure 24 Front Case Disassembly Overlay NIBP cuff hose connector Table 15 Part Descriptions Overlay NIBP Cuff Hose Connector Part Codes Descriptions Qty T0024 0 Front case 1 T8005 0 T8012 0 Front overlay 1 T4104 0 NIBP cuff hose connector 1 A3 Overlay disassembly 1 After step Al push out Overlay from the inside of the front c
61. o a comfortable level Real Time Clock 1 Connect the monitor to an AC power source 2 Press Power button to turn the monitor on 3 Verify that Time display updates every second 18 YM1000 Service Manual YM1000 Printer Test Flash Memory Performance Verification If Printer option installed the following test procedures will verify printer performance 1 2 3 4 5 6 7 8 9 Connect the monitor to an AC power source Press Power button to turn the monitor on Connect all necessary simulators to the monitor Press Printer button when the monitor displays the measurements Verify the measurement values are printed out correctly Press the mode button over 3 seconds configuration mode to select Stream print Kink NIBP cuff hose connector of the monitor and then press NIBP start stop button Verify that the monitor E23 displays and also prints out Open the printer door and then press Print button 10 Verify that the monitor sounds invalid button tone Perform the following procedure to test the flash memory U N e NO AN BD OF A 1 1 Connect the monitor to an AC power source Press Power button to turn the monitor on Change alarm limits and other settings Temperature mode CM Alarm Limit SYS HI 160 Alarm Limit DIA LO 15 Alarm Limit PR HI 180 Alarm Limit SpO2 LO 85 Kink NIBP cuff hose connector of the monitor to generate an error E23
62. odes C F C M EM F Pulse Tone Volume Oto 8 4 Alarm Volume 1to8 4 Night Panel On Off Off Nurse call state Normal Open Normal Close Normal Open Date format Y M D D M Y Y M D Sound mode Full Mid Mute Full Print Control Manual Stream Manual 30 YM1000 Service Manual YM1000 Service Mode and Demo Mode Night Panel Night panel is used to adjust the light intensity of the display With Night Panel selected select YES using only Up selection button to degrade the light intensity between 21 00 to 06 00 select No using only Down selection button not to use this option 8 DIA 9 min nn ITU xspo MAP MIS He Figure 10 Night Panel Nurse Call State Nurse call state is used to select the operating type for Nurse call With Nurse Call State selected select NO Normal Open using only Up selection button select NC Normal Close using only Down selection button DIA HI MAP mo A Figure 11 Nurse Call State YM1000 Service Manual 31 Service Mode and Demo Mode YM1000 Date Format The monitor support two date formats With Date Format selected select Y D Year Month Day using only Up selection button select
63. of digits from 040000 to 070000 after End message appears If fails refer to Troubleshooting section 7 Turn off the monitor 8 After a few seconds power on the monitor DIA MW LJ age MAP Figure 14 NIBP Calibration NIBP Zero Setting The NIBP pressure is calibrated at the factory No periodic recalibrations are required by service personnel The Module automatically performs a baseline zero pressure calibration every 10 15 minutes during operation or sleep mode The exact time between baseline calibrations can vary depending on whether a measurement cycle is in progress at the time the next baseline calibration should take place YM1000 Service Manual 33 Service Mode and Demo Mode YM1000 NIBP Pressure Test The real time value of the system pneumatic pressure is displayed in mmHg For more information refer to Performance Verification section With NIBP Pressure Test selected 1 Place the adult cuff with a rigid PVC vessel 9cm diameter Connect the cuff and the adult hose to NIBP simulator Then connect the adult hose to the monitor 2 Set NIBP simulator to a test mode required 3 Adjust a desired target pressure using Up Down selection buttons 4 Press NIBP start stop button sys r e e LM wa Mm Se ZS l Ll DE Ei DIA ri LI
64. ons Main BD SpO2 FND Modules Assembly NNN 52 Table 15 Part Descriptions Overlay NIBP Cuff Hose Connector NENNEN 53 Table 16 Part Descriptions Battery SMP SAssemb DV EE 54 Table 17 Part Descriptions NIBP Module Assembly eni a t EAA AEN EA A EA OA ETA 55 Table 18 Part Descriptions Printer Assembly Dana naaa NEUE ECEN ETEO EA y 56 Table 19 Part Descriptions Speaker Handle etc Assembly EEN 57 Table 20 Part Descriptions Temperature Module Assenmbly NNN 58 Table 21 Part Descriptions Temperature Case Assembly in srieicinir iiti a ar NORRENA AAA AE A VA 59 RENE RE 63 ii YM1000 Service Manual Introduction Manual Overview Related Documents Description of the YM1000 monitor Warnings el dd dd dd A Warnings are identified by the WARNING symbol shown above Warnings alert the user to potential serious outcomes death injury or adverse events to the patient or user WARNING Explosion hazard Do not use YM1000 in the presence of flammable anesthetics or gases WARNING Do not spray pour or spill any liquid on YM1000 its accessories connectors switches or openings in the chassis WARNING Do not immerse YM1000 or its accessories in liquid or clean with caustic or abrasive cleaners WARNING Ensure that conductive portions of the cables do not come into contact with any other conductive parts WARNING Electrical shock hazard Disconnect the power co
65. operates correctly 2 3 Reboot a PC 2 4 Ensure that Mediana Firmware downloading cable is connected 2 5 Ensure that Firmware downloading cable is properly connected to the data interface port of the monitor Also ensure that the other side of Firmware downloading cable is well connected to a PC 2 6 Check the connection of 9 pin serial wire of the monitor inside 2 7 Replace Main BD if problem persists 44 YM1000 Service Manual YM1000 Troubleshooting Others The followings are symptoms of problems and recommended actions that may happen related to operating the monitor If the action requires replacement of a PCB or module refer to Disassembly Guide 1 No operation but Network indicator flashing after system powers up 1 1 If a cable connected to the data interface port of the monitor disconnect the cable Then turn on the monitor 1 2 Replace Main BD if problem persists 1 3 Replace 9 pin serial wire if problem persists after Main BD replaced 2 During POST all display segments and indicators are illuminated but stopped to process 2 1 Press Power button to turn the monitor off 2 2 Verify that the monitor powers off If the system still powered on open Battery cover Then separate Battery terminals to power off the system 2 3 Download the latest version of Firmware if problem persists 2 4 Replace Main BD if problem still persists 3 Error code E02 often displays after completion of POST 3 1 Check the conn
66. pressure of oxygen P02 This usually occurs because the calculated saturation was not appropriately corrected for the effects of variables that shift the relationship between Po2 and saturation pH temperature partial pressure of carbon dioxide PC02 2 3 DPG and fetal hemoglobin YM1000 Service Manual YM1000 System Processing Description PCO2 y 2 3 DPG __ pH 100 Temperature a Fetal Hb Saturation pH t Temperature t PCO2 t 2 3 DPG T 50 100 PO2 mmHg Oxyhemoglobin Dissociation Curve Functional versus Fractional Saturation This monitor measures functional saturation oxygenated hemoglobin expressed as a percentage of the hemoglobin that can transport oxygen It does not detect significant amounts of dysfunctional hemoglobin such as carboxyhemoglobin or methemoglobin In contrast hemoximeters such as the IL482 report fractional saturation oxygenated hemoglobin expressed as a percentage of all measured hemoglobin including measured dysfunctional hemoglobin To compare functional saturation measurements to those from an instrument that measures fractional saturation fractional measurements must be converted as follows functional saturation fractional saturation a SACL OTE SALUT ALON 100 100 Yocarboxyhemoglobin methemoglobin YM1000 Service Manual 73 System Processing Description YM1000 Temperature Processing Overview Patient temperature c
67. rd from YM1000 before attempting to open or disassemble YM1000 WARNING The use of accessories transducers and cables other than those specified may result in increased emission and or decreased immunity of YM1000 monitor WARNING Do not silence YM1000 audible alarm or decrease its volume if patient safety could be compromised WARNING During safety tests AC mains voltage will be present on the applied part terminals Exercise caution to avoid electrical shock hazard WARNING Do not place YM1000 into operation after repair or maintenance until Performance Safety Tests and NIBP Calibration listed in this service manual have been performed Failure of these tests could result in erroneous readings YM1000 Service Manual 1 Introduction YM1000 Cautions are identified by the Caution symbol shown above Cautions Cautions alert the user to exercise care necessary for the safe and effective use of YM1000 monitor CAUTION U S Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner CAUTION Observe ESD electrostatic discharge precautions when working within the unit and or when disassembling and reassembling YM1000 monitor and when handling any of the components of YM1000 monitor CAUTION When reassembling YM1000 over tightening could strip out the screw holes in the cases rendering it unusable CAUTION If any problem with YM1000 built in an
68. roduct is to the printed circuit board PCB and major subassembly level Once you isolate a suspected PCB follow the procedures in Disassembly Guide to replace the PCB with a known good PCB Check to see if the trouble symptom persists swap back the replacement PCB with the suspected malfunctioning PCB the original PCB that was installed when you started trouble shooting and continue troubleshooting as detected in this section YM1000 Service Manual YM1000 Disassembly Guide Prior to Disassembly 1 Turn YM1000 off by pressing the Power On Off switch 2 Disconnect the monitor from the AC power source Fuse Replacement 1 After Step B2 remove 2 AC main fuses F1 F2 250V 2A out of the socket if required 2 Remove 1 battery fuse F3 250V 6 3A out of the socket if required 3 Replace a new fuse s 4 Reassembly the monitor Battery Replacement This section describes the steps to remove the battery from YM1000 for replacement without disassembling the main case of the monitor B1 Battery disassembly 5 Remove 4 small flat head screws S8094 0 fastening Battery cover 6 Remove Battery cover 7 Remove Battery carefully from the monitor 8 Disconnect the wire between 2 Battery terminals Figure 20 Battery Disassembly YM1000 Service Manual 49 Disassembly Guide YM1000 Monitor Disassembly 50 This section describes the steps to separate the front and rear case assemblies
69. s AC mains power cord to analyzer as recommended by analyzer operating instructions 3 Apply NIBP cuff wrapped tightly around an appropriate metal cylinder 4 Connect a test cable between the cylinder and an input connector on analyzer 5 Turn on YM1000 6 Perform test as recommended by analyzer operating instructions 7 Repeat test for SpO2 and temperature patient connections if those options configured using appropriate test cables Note Patient leakage current is measured with normal and reverse mains polarity For each condition the measured leakage current must not exceed that indicated in Table 5 Table 5 Patient Leakage Current Values Mains Voltage on Applied Part Test Condition Allowable Leakage Current microamps Normal polarity SFC 5000 Reverse polarity SFCRM 5000 Patient Auxiliary Current This test measures patient auxiliary current in accordance with IEC60601 1 clause 19 for Class I type BF equipment The applied voltage for IEC60601 1 the voltage is 264 volts 50 to 60 Hz Patient auxiliary current is measured between each test cable for all possible connections Note Keep the patient test cable length as short as possible during the leakage test Note This test requires the same test cables for each patient connector as described in Patient Leakage Current YM1000 Service Manual 25 Performance Verification YM1000 26 N W a oe o
70. se or medical specialist Note Hospital use typically covers such areas as general care floors operating rooms special procedure areas intensive and critical care areas within the hospital plus hospital type facilities Hospital type facilities include physician office based facilities sleep labs skilled nursing facilities surgicenters and sub acutecenters Note Intra hospital transport includes transport of a patient within the hospital or hospital type facility YM1000 Service Manual 3 Introduction YM1000 The physical and operational characteristics of the monitor are described in the operator s manual and in the Specification section of this manual Figure 1 and 2 identify the displays controls indicators and symbols of the front and rear panels 28 27 26 25 8 91011 1213 14 15 161718 1920 1 Blood Pressure Unit Indicators 15 SpO2 Display 2 Systolic Blood Pressure Display 16 Mode Button 3 Patient Type Indicators 17 Pulse Amplitude Indicator 4 Diastolic Blood Pressure Display 18 Alarm Silence Indicator 5 Pulse Rate Display 19 Up Down Selection Button 6 MAP Mean Arterial Pressure Display 20 Alarm Silence Button 7 Print Setting Indicators 21 BP start stop button 8 Print Button 22 Temperature Unit Mode Indicators 9 Alarm Button 23 Temperature Display 10 Auto Indicator 24 Power Button 11 Auto Cycle Display 25 Battery Indicator 12 Auto Button 26 Charging AC in Indicator 13 Pulse To
71. ssions Group 1 Class B Limits and methods of measurement of radio disturbance characteristics of industrial scientific and medical ISM radio frequency equipment Labeling EN1041 1998 Information supplied by the manufacturer with medical devices Marking IEC TR60878 2003 Graphical symbols for electrical equipment in medical practice EN980 2003 Graphical symbols for use in the labeling of medical devices ISO7000 2004 Graphical symbols for use on equipment index and synopsis EN60417 1 1999 Graphical symbols for use on equipment overview and application EN60417 2 1999 Graphical symbols for use on equipment symbol originals EN50419 2005 Marking of electrical and electronic equipment in accordance with article II 2 of directive 2002 96 EC WEEE Package ISTA Pre Shipment Test Procedures Procedure 1A 1994 Rev Reliability IEC60068 2 27 Environmental testing Shock IEC60068 2 6 1995 Environmental testing Vibration sinusoidal IEC60068 2 64 1993 Broadband random Digital Control and Guidance YM1000 Service Manual 11 Specification YM1000 This page is intentionally left blank 12 YM1000 Service Manual Routine Maintenance Cleaning Periodic Safety and Functional Checks Functional Checks Batteries Environmental Protection WARNING Do not spray or pour any liquid on the monitor or its accessories Do A not immerse YM1000 or its accessories in liquid or clean with caustic or abrasive cleaners
72. t below sea level 4 877 m 16 000 ft above sea level Transport and Storage Temperature 20 C 4 F to 50 C 122 F Humidity 15 RH to 95 RH non condensing Altitude 610 m 2 000 ft below sea level 12 192 m 40 000 ft above sea level Note The system may not meet its performance specifications if stored or used outside the manufacturer s specified temperature and humidity range YM1000 Service Manual Specification YM1000 Measurement Parameters NIBP Pulse Rate Pulse Rate Range Adult Pediatric Neonatal 30 BPM to 220 BPM Pulse Rate Accuracy 3 BPM or 3 whichever is greater NIBP Non Invasive Blood Pressure Technique Oscillometric Measurement Measurement modes AUTO MANUAL and STAT AUTO Mode Automatic NIBP measurements at intervals of 1 2 3 4 5 10 15 30 45 60 90 120 and 240 minutes MANUAL Mode Single measurement initiated by NIBP Start Stop switch STAT Mode Series of consecutive measurements for 5 minutes NIBP pressure measurement range Systolic pressure range Adult 30 mmHg to 260 mmHg 3 9 kPa to 34 5 kPa Pediatric 30 mmHg to 160 mmHg 3 9 kPa to 21 2 kPa Neonatal 25 mmHg to 120 mmHg 3 3 kPa to 15 9 kPa Diastolic pressure range Adult 20 mmHg to 235 mmHg 2 6 kPa to 31 2 kPa Pediatric 15 mmHg to 130 mmHg 1 9 kPa to 17 2 kPa Neonatal 10 mmHg to 105 mmHg 1 3 kPa to 13 9 kPa Mean pressure
73. t head 7 S8066 0 Screw W 3 x 5 tapping S 58071 0 Screw 3 x 8 tapping 58096 0 Screw 3 x 25 tapping S8097 0 Nut M3 YM1000 Service Manual Packing For Shipment General Instructions Returning the YM1000 Repacking In Original Carton Repacking In a Different Carton General Instructions To ship the monitor for any reason follow the instructions in this section Pack the monitor carefully Failure to follow the instructions in this section may result in loss or damage not covered by the Mediana warranty If the original shipping carton is not available use another suitable carton North American customers may call Mediana Technical Services to obtain a shipping carton Prior to shipping the monitor contact your supplier or the Mediana office Technical Services Department for a returned goods authorization RGA number Mark the shipping carton and any shipping documents with the returned goods authorization number Pack to shipping the monitor contact your supplier or the Mediana office Technical Services Department for a returned goods authorization number Mark the shipping carton and any shipping documents with the returned goods authorization RGA number Return YM1000 by any method that provides proof of delivery Returning the YM1000 Contact Mediana Technical Services Department for shipping instructions including a Returned Goods Authorization RGA number Unless otherwise instructed by Me
74. t is connected to a test lead from the electrical safety analyzer Table 4 Patient Leakage Current Values Test Condition Allowable Leakage Current microamps Normal Condition NC 100 SFC Open Supply OS 500 SFC Open Earth SFC OE 500 Normal Condition RM NCRM 100 SFC Open Supply RM SFC OSRM 500 SRC Open Earth RM SFC OERM 500 YM1000 Service Manual YM1000 Performance Verification Patient Leakage Current Mains Voltage on the Applied Part A A WARNING AC mains voltage will be present on the applied part terminals during this test Exercise caution to avoid electrical shock hazard WARNING Do not touch the patient leads clips or the simulator parts connected to patient leads during this test as an electrical shock will occur This test measures patient leakage current in accordance with IEC60601 1 clause 19 for Class L type BF equipment In this test 110 of mains voltage is applied between each patient connection and earth power ground Patient leakage current is then measured from any individual patient connection to earth Note Keep the patient test cable length as short as possible during the leakage test Note This test requires the same test cables for each patient connector as described above Patient Leakage Current m Configure electrical safety analyzer as recommended by analyzer operating instructions N Connect the monitor
75. tion explains how to troubleshoot YM1000 if problems arise Tables are supplied that list possible difficulties and recommended actions to correct the difficulty How to Use This Section Use this section in conjunction with Performance Verification section and Spare Parts section To remove and replace a part you suspect is defective follow the instructions in Disassembly Guide section Who Should Perform Repairs Only qualified service personnel should open the monitor housing remove and replace components or make adjustments in accordance with this service manual If your medical facility does not have qualified service personnel contact Mediana Technical Services Replacement Level Supported The replacement level supported for this product is to the printed circuit board PCB assembly and major subassembly level Once you isolate a suspected PCB assembly follow the procedures in Disassembly Guide section to replace the PCB assembly with a known good PCB assembly Check to see if the trouble symptom disappears and that the monitor passes all performance tests If the trouble symptom persists swap back the replacement PCB assembly with the suspected malfunctioning PCB assembly the original PCB assembly that was installed when you started troubleshooting and continue troubleshooting as directed in this section Obtaining Replacement Parts Mediana Technical Services provides technical assistance information and replacement parts
76. ttery A lead acid battery is used in the YM1000 It is rated at 6 volts DC 4 amp hours When new and fully charged the battery will operate the monitor for 2 hours A new battery will last 10 minutes from the time the low battery alarm is declared until the unit is shut down due to battery depletion Recharging the battery to full capacity takes 12 hours Changing from AC to battery power does not interrupt the normal monitoring operation of the YM1000 Power Regulator The Power Regulator receives the inputs from the SMPS the Battery and generates an appropriate power rate Main MCU The Main MCU is the heart of the YM1000 The MCU is a Rabbit 3000 Rabbit 3000 manages each modules to generate signal outputs from data received on the base of the internal algorithm The MCU controls sound generation button check and SMPS operation The Rabbit 3000 also communicates with NIBP Module SpO2 Module Temperature Module Printer Display driver and Personal Computer YM1000 Service Manual YM1000 System Processing Description Slave MCU Slave MCU is Toshiba TMP86PM47U Slave MCU is mainly used for display driver Slave MCU checks on Battery voltage level to transfer the level to Main MCU and also it controls SMPS function during Firmware downloading mode Button Interface 10 buttons including Power button interfaces Main board directly Button access controls the monitor functions including power on off operating mode transition alarm
77. will be displayed Connect the monitor to AC power source using proper power cord Verify Charging AC in indicator is lit or flashing Press Power button over 1 second and then verify that the monitor is turned on 1 2 3 4 After the monitor operates in normal mode disconnect the power cord 5 Verify Battery indicator is lit instead of Charging AC in indicator 6 Press Power button over 1 second and then verify that the monitor is turned off Battery Charge 1 Connect the monitor to AC power source using proper power cord the monitor is turned off 2 Verify Charging AC in indicator is lit or flashing Note If Charging AC in indicator is flashing the battery needs fully charging 3 Charge the battery fully until Charging AC in indicator is no more flashing It takes for at least 12 hours 4 To check for a full charge disconnect the power cord Press Power button and the NIBP start stop button simultaneously over 1 second to enter the Service mode Then select battery voltage level displayed 5 Verify that current battery voltage display in Service mode indicates 6 0V or greater Note The battery may require a complete charge discharge cycle to restore its normal capacity depending on its previous usage Battery Discharge 16 1 Disconnect the power cord from the monitor with fully charged battery N Turn on the monitor by pressing Power button over 1 second W Connect NIBP s
78. y is used to heat the probe tip prior to taking a temperature reading in order to speed the convergence of the prediction algorithm A fail safe hardware shut off circuit is included to ensure the heater will shut down in the event of a software failure When the probe is first extracted and colder than 33 9C the heater pulse widths are at a maximum percentage On vs Off to warm the probe quickly When the probe reached 33 9 C the pulse widths narrow to a duty cycle just enough to maintain temperature When the probe is placed in the mouth the heat supplied by the mouth makes the pulse widths reduce to zero This reduction to zero and probe being at least up to 33 1 C 91 6 F triggers the start of the prediction algorithm The shape of the rising temperature curve is monitored and the best fit to a curve is found When the curve fit is stable the final predicted temperature is provided 74 YM1000 Service Manual

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