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Safety Testing

84

Chapter 8 - Test and Inspection Matrix

Safety Testing

This section defines the test and inspection procedures applicable to the FM-2
fetal monitors. Use the tables in the following section to determine what test and
inspection results must be reported after a repair has been carried out.

•

Test Blocks

in Table 20 tells you when to carry out the tests blocks

•

Test and Inspection Matrix

tells you the expected results of the

tests and what to record.

Warning
Apply the safety test limits set by the local standards and statutes applicable
to the country of installation, such as IEC 601-1, UL2601, CAN/CSA-
C22.2 No. 601.1.M90.

The safety tests defined in this chapter are derived from local and
international standards but may not be equivalent. They are NOT a
substitute for local safety testing.

Caution
Successful completion of the patient safety tests does not ensure the correct
and accurate functioning of the equipment.

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Summary of Contents for FM-2

Page 1: ...FM 2 M2922A Antepartum Fetal Monitor S E R V I C E G U I D E M2922 9000B Printed in Germany March 2002 Edition 1 ...

Page 2: ... may be the trademarks of their respective owners Printing History M2922 9000A 08 01 M2922 9000B 02 02 Conventions Used in This Guide Warning A warning alerts you to a potential serious outcome adverse event or safety hazard Failure to observe a warning may result in death or serious injury to the user or patient Caution A caution alerts you where special care is necessary for the safe and effecti...

Page 3: ... US law restricts this device to sale by or on the order of a physician On your monitor this sign indicates that there is detailed information in this book which you must read before proceeding with your task ...

Page 4: ......

Page 5: ...ice 6 General Description 6 Block Diagram of Operation 7 Mechanical Description 8 LCD and Backlight 8 Serial I O Communications Port 8 Parallel I O Communications Port 8 Keypad and Navigation Wheel 9 Power Supplies 9 Measurements Channels 10 Ultrasound Channel 10 Toco Channel 10 Mountings 10 Routine Maintenance and Cleaning 11 2 System Interfaces 13 Overview 13 Serial I O Communications Interface ...

Page 6: ...p Default Settings and the Service Menu 25 Introduction 25 Power up Defaults Settings 25 Service Menu 26 Error Log 28 System A D Values 29 5 Troubleshooting 31 General 31 Initial Trouble Diagnosis 32 Power Problem Diagnosis 33 Diagnostic Flow Chart 33 Diagnostic Repair Actions 34 Monitoring Degradation Problems 35 Diagnostic Flow Chart 35 Diagnostic Repair Actions 36 6 Disassembly Reassembly Guide...

Page 7: ...ng the Keypad 54 Rear Case Disassembly Procedures 55 Removing the Rear Connector PCB and the Interface Board 55 Removing the Interface PCB from the Rear Connector PCB 56 Replacing the Interface PCB on the Rear Connector PCB 56 Replacing the Rear Connector Interface PCB Assembly 57 Removing the Handle 58 Removing the Foot Cushions 58 Main PCB Disassembly Procedures 59 Removing the Side Panel and Si...

Page 8: ...on Matrix 77 Warnings 77 Cautions 78 Introduction 79 When to Perform Tests Blocks 80 Battery Charging and Maintenance 82 Using the Battery 82 Low Power Warning 82 Recharging the Battery 83 Storing 83 Preventive Maintenance 83 Safety Testing 84 Safety Test Procedures 85 Ground Integrity 86 Electrical Leakage 86 Safety Test 1 Enclosure Leakage Current Test 86 Safety Test 2 Patient Leakage Current Te...

Page 9: ...ories M2922A 66 Table 10 M2922 64003 Small Parts Kit 66 Table 11 M2922 64001 Housing Kit 67 Table 12 M2922 64002 Monitor Speaker Kit 68 Table 13 M2922 40003 Battery Kit 68 Table 14 M2922 60406 Knob Navigation Wheel Kit 69 Table 15 M2922 44301 Keypad Kit 69 Table 16 M2922 64004 Display Kit 69 Table 17 M2922 66505 Side Connector PCB Kit 70 Table 18 M2922 66510 Interface PCB Kit 70 Table 19 M2922 665...

Page 10: ......

Page 11: ...embly Drawing Sheet 1 Top Level Assembly 71 Figure 8 Assembly Drawing Sheet 2 Front Case Assembly 72 Figure 9 Assembly Drawing Sheet 3 Rear Case Assembly 73 Figure 10 Assembly Drawing Sheet 4 Interface PCB Rear Connector PCB 74 Figure 11 Assembly Drawing Sheet 5 Side Connector PCB Panel Label 75 Figure 12 Testing a Toco Transducer 91 Figure 13 Testing an Ultrasound Transducer 92 Figure 14 Position...

Page 12: ......

Page 13: ...rmed during normal operation Any other maintenance and repair procedures beyond the level covered in the Instructions for Use are limited to replacement of the battery three board assemblies inside the case but excluding the main PCB the speaker components of the LCD display installed in the front case assembly The features available on the monitor you are servicing depend on which accessories wer...

Page 14: ...determine whether a fault is a hardware or software problem Fault rectification is accomplished by replacement of the defective part at the assembly level For example faults may be repaired by replacement of a complete board where the fault is identified or by exchanging the monitor Repair or replacement of individual components on the boards is not supported and should never be attempted There ar...

Page 15: ... may result in injury or death to you or the patient Caution A caution precedes an action that may result in damage to or malfunction of the monitor It indicates that special care is necessary for the safe and effective servicing of the monitor Note A note calls your attention to an important point in the text On your monitor this sign indicates that there is detailed information in this book and ...

Page 16: ...n monitor Type BF applied part symbol on monitor Power input symbol on power supply Refer to accompanying documents Power supply connector symbol on monitor RS 232 connector symbol on monitor housing Power supply output connector on power supply RS 232 connector symbol on monitor label Functional earth symbol on power supply Printer connection symbol on monitor Indoor use only symbol on power supp...

Page 17: ...d if necessary accessory items in original packaging 2 Place in shipping carton and seal carton with packaging tape 3 Label carton with shipping address and return address Repacking in a Different Carton If the original carton is not available use the following procedure to pack the monitor 1 Place the monitor in a plastic bag 2 Locate a corrugated cardboard shipping carton with at least 200 pound...

Page 18: ...e replaceable assemblies that may be identified as the probable cause of an apparent malfunction Refer to the Instructions for Use for information about the operation of the monitor and of the Recorder That manual includes descriptions of the installation and setup of the monitor modes of operation recording of real time patient data and transmission of patient data to local or remote PCs ...

Page 19: ...f Operation Figure 1 illustrates the functional operation of the monitor including the accessories and options It incorporates features of the mechanical design indicating the physical relationship of the assemblies and components Figure 1 FM 2 Block Diagram of Operation ...

Page 20: ...Backlight The LCD panel is a monochrome LCD display It is a single panel display with a resolution of 320 X 240 pixels Data to be displayed are stored in the main board Direct connection to the LCD panel is made through on board header assembly J7 The backlight of the LCD is a Cold Cathode Fluorescent Lamp CCFL mounted as part of the LCD panel The AC high voltage is turned on and off by a digital ...

Page 21: ...push button switch As the knob is rotated quadrature coded outputs are generated The phase relationship between the two signals in quadrature reflect the clockwise or counter clockwise rotation of the wheel This relationship is translated to move the cursor on the LCD display forward or backward depending on which way the wheel is rotated Power Supplies The unit is operated from a 6 volt 4 AH seal...

Page 22: ...cessed in the CODEC circuitry on the main board Toco Channel The Toco circuit uses a Wheatstone bridge with two strain gauge elements mounted on a load beam The differential output voltage is proportional to the force applied to the load beam through the plunger The Toco circuit is powered from a single regulated 5V supply excitation The amplified and filtered TOCO signal is converted by a 12 bit ...

Page 23: ...General Information 11 Routine Maintenance and Cleaning For detailed instructions on how to clean the monitor and the monitoring accessories see the Instructions for Use For instructions on cleaning the Recorder refer to the Instructions for Use ...

Page 24: ...Routine Maintenance and Cleaning 12 Chapter 1 General Information ...

Page 25: ...e of high speed optical isolators and isolated 5 volt power supply The RS 232 communications interface port is for communicating with a desktop modem see Supported Modems on page 14 a GSM cell phone modem see Supported Modems on page 14 a PC AT computer The RS 232 communications protocol supports connections to OB TraceVue These connections are direct cable connection to the OB TraceVue system to ...

Page 26: ... of a medical device in terms of leakage current and isolation a modem must be located outside of the patient vicinity The following modems are the only modems that are currently validated and supported Table 1 Fully wired DB9 RS 232 Null modem pinouts Pin Connects to pin Signal Details 1 and 6 4 DTR Data Terminal Ready 2 3 TxD Transmit data to external devices 3 2 RxD Receive data to external dev...

Page 27: ... AT at the beginning of the initialization string start the command mode The r at the end represents a Return when the characters entered in the command line and stored in the modem s command buffer are executed The monitor always automatically enters the Attention AT and Return r characters Therefore the user never needs to enter AT or r The dialing also works in the same manner The user never ne...

Page 28: ...eceived then it is positive confirmation that the modem is connected and functional X4 Switches to extended result codes along with smart dialling The modem checks for a dial tone dials then checks for a ring back or a busy signal after dialling This is not appropriate in local exchange branches X0 Selects basic result codes and blind dialling dials even if there is no line as an alternative to us...

Page 29: ... consequently no other modems are officially supported Customers may use any other modem after successful verification of several trace transmissions Nokia 6210GSM Instead of a conventional wired phone connection using a desktop modem a cellular phone can be used to transmit traces to the viewer or to OB TraceVue At the time of printing the Nokia 6210GSM is the only cellular phone to date that has...

Page 30: ...ort should be located outside the patient vicinity as the two interfaces are not isolated against eachother The parallel communications port is used to connect the FM 2 to the Recorder or to a standard PCL Level 3 printer Supported printers that have been validated at the time of printing are HP Deskjet 640c HP Deskjet 840c HP Deskjet 990 CXi HP Deskjet 980 CXi HP Deskjet 960c HP Deskjet 840c HP D...

Page 31: ...l board repair Overview of the Service Tests A brief overview of the service tests that are used to verify performance following repairs or during routine maintenance follows All tests can be performed without removing the covers of the monitor Visual Test see page 20 Power On Self Test see page 20 Performance tests for transducers to check the processing of the signal from the transducers see Tes...

Page 32: ...se if there is any sign of damage FM 2 Power On Self Test When the monitor is turned on it automatically performs a diagnostic self test The self test continues during normal operation also If the monitor fails its self test it will display an error screen and will discontinue all monitoring functions In this case it should be turned off and removed from service What Happens During the Power On Se...

Page 33: ...fter two or three seconds the monitor plays a two tone power on jingle while performing the Power On Self Test At this point the monitor displays the start up screen showing the Agilent logo bootcode version and the application version 4 Upon successful completion of the Power On Self Test the display will show the main monitoring screen 5 If an error is detected the monitor will display the error...

Page 34: ...ted transducers in the appropriate frames Also refer to Testing Transducers on page 90 Error Handling There are two types of error that you may see those that the monitor cannot self detect and those that it can self detect If an operational error occurs that is not self detected the monitor shuts down There will be no audible or visual warnings or indicators If a self detectable error occurs the ...

Page 35: ...re etc 4 Stack overflow 5 Bad parameter value passed to a function 6 Software is in an unexpected state 7 Software assertion was false coding error 8 A task failed to check in with the watchdog timer 9 The CRC of the software in memory is invalid 10 A voltage is out of range Check the battery and the power supply for correct opera tion Replace if necessary 11 Watchdog timer is not functioning Repl...

Page 36: ...nd file None factory diagnostic infor mation only 51 Corrupt file system 52 Attempt to read a deleted file 53 File system wrapped memory 54 Attempt to read a corrupt file 55 Failed to create a file 70 File corrupted FM 2 viewer communication error None factory diagnostic infor mation only 71 Invalid Patient ID FM 2 viewer communication error 72 Invalid sequence number FM 2 viewer communi cation er...

Page 37: ... create a power up default for many settings in the monitor Power up defaults are the settings in effect each time the monitor is powered on The power up default settings are configured at the factory prior to shipment Some of the parameters are stored when the monitor is powered down and these are classified as saved through power cycle The factory default values are defined in Table 4 Table 4 Po...

Page 38: ...oblems To access the Service Menu press the navigation knob when the Power Status Frame is selected The following can be viewed from the Service Menu Data transfer Disabled Yes if real time transfer Data Transfer Destination Recorder Printer Yes Recorder Paper speed 3 cm minute Yes Recorder Paper style US Yes Time format 12 hour Yes Date today Yes Date format mm dd yy Yes Patient ID time date enco...

Page 39: ...og System Analog to Digital A D Values Table 5 Service Menu Entries Menu Item Explanation View Error Log Displays the error log menu View A D Values Displays the Analog to Digital A D Menu System On Time Elapsed system on time expressed in hours System on time is not reset to 0 after the battery is replaced but is retained This value is saved through power cycles Language English German Spanish It...

Page 40: ...ror This means that if there are many occurrences of one type of error code that one error code won t overwrite the other seven error codes Next to the occurrence field is the time and date of the most recent occurrence of the error code Error codes may not be changed or reset in this screen When in the Error Code screen the Return item is always highlighted a press of the wheel will return the us...

Page 41: ...and battery voltage The A D values displayed are static being acquired when the screen is first displayed None of the displayed values may be changed or reset in this screen When in the A D screen the Return item is always highlighted a press of the wheel will return the user to the Service Menu Rotating the wheel while in the A D screen will have no effect The A D Values screen appears as follows...

Page 42: ...Service Menu 30 Chapter 4 Power up Default Settings and the Service Menu ...

Page 43: ...arts and step by step procedures are provided as aids in the troubleshooting process The chapter leads you to a probable field replaceable assembly or component Items that are serviceable only at the factory are also identified as well as instructions for their return for repair replacement The initial analysis determines whether the apparent malfunction is caused by a replaceable accessory or by ...

Page 44: ...e condition or Degraded operation The totally inoperative condition is indicated by the failure of the monitor to respond to the power ON front panel action or by complete loss of monitoring functions during operation Contact your local Agilent Response Center Degraded operation performance might be indicated by the appearance of artifacts in the display or by gaps in the pixel display by intermit...

Page 45: ... use after the initial diagnosis of a total failure as a power supply or display problem Note If the apparent total failure is caused by a malfunctioning display backlight you may see a faintly lit display with the appropriate Power On Self Test message The troubleshooting under these circumstances is described in this section Figure 5 Power Diagnosis Power Supply or Display ...

Page 46: ...kground room illumination If only the back light fluorescent tube or its high voltage driver has failed the display may be faintly visible Refer to page 50 for removal procedures Replace Battery Refer to page 43 Exchange the Monitor If the display is not at all visible and there is total failure exchange the monitor ...

Page 47: ...Figure 6 illustrates a logical sequence of troubleshooting diagnostics when the monitor appears to be operative but the displayed results are suspect for any number of reasons The resulting diagnosis will result in replacing either the monitor or the transducers Figure 6 Monitoring Degradation Diagnostic Flow Chart ...

Page 48: ...y of the display Note the values being reported in the numerical frames FHR s and TOCO Are they clearly unreasonable Swap Transducers Use a spare transducer that is free of defects and meets factory specifications At facilities where more than one monitor is installed it may be convenient to borrow a transducer that is working satisfactorily with another monitor Exchange the Monitor If the monitor...

Page 49: ...ure to perform all tests could result in erroneous monitor readings or patient operator injury Warning Energized circuits are accessible with the covers open Do not work on the monitor with the covers open Only qualified service personnel should open or disassemble the monitor Introduction Warning Before attempting to open or disassemble the monitor disconnect the power supply from the monitor War...

Page 50: ...nction buttons chassis enclosures Remember to store all screws nuts washers and other parts in a safe place for later refitting How to Use this Chapter The step by step procedures that are used to access replaceable parts of the monitor are illustrated in the Disassembly sections which follow These describe and photographically illustrate procedures for disassembling the monitor to enable removal ...

Page 51: ...driver A torque sensitive tool with a torque range to 1 1 Nm 10 in lb accuracy 0 1 Nm 1 in lb needle nose pliers or Tinnerman tool 10 mm socket driver for wheel encoder nut 3 16 socket driver The rear case assembly consists of a molded plastic case in which the battery is stored The speaker housing is mounted on the back of the rear case assembly and also forms the cover for the battery Through ho...

Page 52: ...housing see Removing the Speaker Housing on page 41 Caution Important for disassembly When disassembling the monitor make sure that the battery leads are disconnected Otherwise it is likely that circuit damage will occur Caution Important for reassembly If the internal battery cable has been disconnected pay very careful attention to the polarity of the cable before reattaching The red wire connec...

Page 53: ...ery cover Step 3 Gently lift the bottom screw end of the speaker cover just enough for the battery pad attached to the inside of the speaker housing to clear the bottom of the rear case At the same time slide the speaker housing towards the bottom of the rear case to free the two lugs holding the top of the speaker housing The speaker housing is now free of the rear case but with the wires still c...

Page 54: ... not coded for polarity as the polarity is uncritical Step 2 Refit the speaker housing by sliding the two metal lugs at the top end of the speaker housing under the lip at the top of the battery housing aperture until it stops Step 3 Secure the speaker housing with the two fastening screws Torque the screws to 0 7 to 0 9 Nm 6 to 8 in lb Caution Do not overtorque the screws as the plastic screw mou...

Page 55: ...l end of the battery nearest the work surface This should cause the battery to fall partly out of the case Step 3 Carefully remove the battery from the monitor Take care not to put too much stress on the battery wires as you take the battery out of the case Step 4 Disconnect the battery cables by sliding the spade connectors off the battery terminals Caution During reassembly pay very careful atte...

Page 56: ...nal marked in red Connect the black cable to the negative terminal marked in black Step 2 Carefully place the new battery into the battery housing Step 3 Reconnect the speaker and refit the speaker assembly See Replacing the Speaker Housing on page 42 Battery Disposal Refer to practices and procedures used at the local institution when disposing of the battery Please conform to any local laws and ...

Page 57: ...e four screws fastening the rear case assembly to the front case assembly using a Phillips head screwdriver Step 4 Separate the front and rear case assemblies Note The US and Toco sockets protrude slightly from the face of the connector panel on the side of the monitor While separating the front and rear case assemblies you may feel some resistance at the connector panel end of the monitor in whic...

Page 58: ...e moulding Take care that it stays aligned while you push the front and rear case assemblies together When the reassembly is complete the edge of the case opening should sit evenly in the groove of the connector panel Step 4 Align the ridge in the front case assembly with the groove in the rear case assembly Step 5 Check that the four screw holes align correctly Step 6 Drive in the four screws tha...

Page 59: ...fit on the stem of the encoder The encoder is attached to the main circuit board and has a threaded moulded base just below the rotating stem of the encoder The threaded base accepts a 10 mm nut which fastens the encoder assembly to the front bezel Step 1 From the front remove the wheel by grasping the sides of the wheel firmly and pulling straight back from the monitor If the wheel is not easily ...

Page 60: ... Main PCB Assembly on page 52 to the front case assembly Step 2 Screw the 10 mm nut onto the threaded base of the encoder switch from the outside of the front bezel initially by hand Caution Do not overtorque If excessive torque is applied to the encoder nut damage will occur to the encoder switch Do not exceed the maximum allowable torque setting Step 3 Using a torque sensitive tool torque the nu...

Page 61: ...6 on the main PCB To remove the cable from the connector first release the locking cap to loosen the cable Slide the cable out leaving the cap loosely seated in the connector Step 5 Use a Phillips head screwdriver to remove the screw holding the main PCB assembly in place in the front cover assembly Step 6 Remove the main PCB by gently pulling upwards to disconnect the multipin LCD assembly connec...

Page 62: ... monitor with the covers open The Display Kit M2922 64004 comes with a replacement display window which should be replaced when the LCD assembly is replaced Step 1 Use a Phillips head screwdriver to unfasten the four corner screws Step 2 Remove the LCD assembly providing access to the display window Rear case assembly Front case assembly Main PCB assembly Main PCB assembly LCD assembly Screws ...

Page 63: ...tep 1 Fit the new display window with its gasket to the inside of the front bezel The display window comes with its own double sided adhesive Step 2 Position the LCD assembly so that the holes in each corner align with the four screw mounts on the inside of the front bezel Step 3 Using a Phillips head screwdriver fasten the LCD assembly with the four fixing screws LCD assembly Front bezel Display ...

Page 64: ...rapped underneath the main PCB but are free and accessible from the side of the main PCB Step 4 With the guide in the front cover still located in the notch at the patient connector end of the main PCB carefully align the connector J7 on the main PCB with the corresponding pins on the LCD assembly Step 5 Press down gently until the connector at J7 on the main PCB is fully seated on the pins on the...

Page 65: ... connector one way round Step 8 Reconnect the keypad ribbon connector by inserting the ribbon cable fully into the connector at J6 on the main PCB through the locking cap which was left loosely fitted to the connector during disassembly Slide the locking cap forward to secure the ribbon cable Notch guide Notch guide Keypad ribbon cable Backlight power connector connector Main PCB screw fixing ...

Page 66: ... Note The keypad is made up of a number of different layers which may separate during removal Ensure that all layers are removed completely before a replacement is fitted Replacing the Keypad Step 1 Ensure that the recess in the front bezel for the keypad is clean Step 2 Thread the ribbon cable through the slot in the front cover Step 3 Carefully align one end of the keypad with the corresponding ...

Page 67: ...Front and Rear Case Assemblies on page 45 Removing the Rear Connector PCB and the Interface Board The interface PCB is connected at right angles to the rear connector PCB and is separable from it Step 1 From outside the rear cover use a 3 16 socket driver to remove the two standoff fasteners of the RS 232 connector and also the two standoff fasteners of the parallel connector Step 2 From inside th...

Page 68: ...the connector PCB Step 2 Separate the two boards by disconnecting the two multi pin connectors at J1 and J2 on the rear connector PCB Ensure that you pull straight with no twisting action so that the pins do not get bent Replacing the Interface PCB on the Rear Connector PCB The refitting procedure is the reverse of the removal procedure Screws Rear connector board Interface board Interface board R...

Page 69: ...ase Step 2 From outside the rear case use a 3 16 socket driver to refit the two standoff fasteners of the RS 232 connector and the two standoff fasteners of the parallel port to secure the rear connector PCB in place Step 3 Ensure that the speaker cable connector is secure on the interface PCB Check that the two pins on the board are perpendicular to the board or leaning slightly towards the conne...

Page 70: ...Step 2 When the end of the handle has begun to loosen from the boss use the same technique to begin to pry up the other end Step 3 Alternately apply this prying action between each end of the handle until the handle is free of the rear case Removing the Foot Cushions The foot cushions are attached with an adhesive to the bottom surface of the rear cover and can be removed by lifting one end of the...

Page 71: ...ration of Front and Rear Case Assemblies on page 45 Step 2 Then remove the main PCB assembly from the front case assembly as described on page 49 Removing the Side Panel and Side Connector PCB Step 1 Use needle nose pliers or a Tinnerman tool to remove the two Tinnerman fasteners securing the white plastic side panel to the underside of the main PCB Step 2 The side panel is attached by screws to t...

Page 72: ... Guide Step 3 Use a Phillips head screwdriver to remove the six screws that secure the side panel to the socket surrounds Access to the screws is gained through the holes in the side connector PCB Step 4 Remove the side panel from the side connector PCB J3 on main PCB ...

Page 73: ...ign the pins at J3 on the main PCB with the corresponding multipin connector on the side connector PCB Step 4 Push down until the pins at J3 on the main PCB are fully mated with the multipin connector on the side connector assembly There should be no gap between the bottom of the side connector PCB and the main PCB Ensure that the side connector PCB is perpendicular to the main PCB Step 5 From und...

Page 74: ...Main PCB Disassembly Procedures 62 Chapter 6 Disassembly Reassembly Guide ...

Page 75: ...responds to the callout number in Figure 7 through Figure 11 The Page Ref indicates the page number of the relevant disassembly procedures in Chapter 6 Small Parts Kit Most small parts and hardware screws and so forth can be found in the Small Parts Kit Part Number M2922 64003 The Small Parts Kit is supplied with every major spare part ...

Page 76: ...r M2925A Table 6 Exchange Assemblies M2922A Exchange Part No Description M2922 68000 Entire monitor M1355 69011 TOCO Transducer M1356 69011 US Transducer Table 7 Exchange Assemblies M2925A Exchange Part No Description M2925 68110 Recorder 100V 120V M2925 68220 Recorder 220V 240V ...

Page 77: ...2922 40003 Battery 43 44 4 M3921 60406 Navigation wheel 47 M2922 64001 Housing kit 5A 5B M2922 64004 Display assembly kit 50 51 6 M2922 64002 Speaker kit 41 42 7 M2922 44301 Key pad 54 M2922 64003 Small parts kit 8 M2922 60511 Rear connector board 55 57 M3921 61000 Power supply 100V 120V M3921 61010 Power supply 220V 240V M1380 61624 Serial interface cable to PC OB TraceVue and FM 2 viewer 15249A ...

Page 78: ...upplies and Accessories M2922A Part No Description M1356 43203 Transducer knob adapters 3 pack Table 10 M2922 64003 Small Parts Kit Component Description Quantity Screw mach Phillips head 4 40 X 3 16 4 Screw tri lob Phillips head 6 X 1 2 6 Ring retaining ext 1 8 shaft 2 Screw tri lob Phillips head 4 X 3 8 17 Retaining ring for wheel 1 Screw locking kit 2 ...

Page 79: ...7 M2922 64001 Housing Kit Table 11 M2922 64001 Housing Kit Component Description Quantity Small Parts Kit1 1 For contents of the Small Parts Kit refer to Table 10 on page 66 1 Front case 1 Louver cover plate 1 Handle 1 Rubber feet cushions 2 Speaker retainer spring 1 ...

Page 80: ...Parts Kit refer to Table 10 on page 66 1 Speaker housing 1 Bracket R A 4 40 1 Speaker retainer 1 Speaker 1 Cable speaker assembly 1 Gasket speaker 1 Pad battery front rear 1 Label rear 1 Pad battery front rear 1 Pad battery right 1 Pad battery left 1 Table 13 M2922 40003 Battery Kit Component Description Quantity Small Parts Kit1 1 For contents of the Small Parts Kit refer to Table 10 on page 66 1...

Page 81: ...ion Quantity Knob 1 Ring retaining 3 8 shaft 1 Table 15 M2922 44301 Keypad Kit Component Description Quantity Small Parts Kit1 1 For contents of the hardware mounting kit refer to Table 10 on page 66 1 Keypad switch membrane 1 Table 16 M2922 64004 Display Kit Component Description Quantity Small Parts Kit1 1 For contents of the Small Parts Kit refer to Table 10 on page 66 1 LCD assembly 1 Window d...

Page 82: ...ontents of the Small Parts Kit refer to Table 10 on page 66 1 Side PCB with twin ultrasound and one Toco sockets 1 Table 18 M2922 66510 Interface PCB Kit Component Description Quantity Small Parts Kit1 1 For contents of the Small Parts Kit refer to Table 10 on page 66 1 Interface PCB 1 Table 19 M2922 66511 Rear Connector PCB Kit Component Description Quantity Small Parts Kit1 1 For contents of the...

Page 83: ...Assembly Drawings Chapter 7 Spare Parts 71 Assembly Drawings Figure 7 Assembly Drawing Sheet 1 Top Level Assembly ...

Page 84: ...Assembly Drawings 72 Chapter 7 Spare Parts Figure 8 Assembly Drawing Sheet 2 Front Case Assembly ...

Page 85: ...Assembly Drawings Chapter 7 Spare Parts 73 Figure 9 Assembly Drawing Sheet 3 Rear Case Assembly ...

Page 86: ...Assembly Drawings 74 Chapter 7 Spare Parts Figure 10 Assembly Drawing Sheet 4 Interface PCB Rear Connector PCB ...

Page 87: ...Assembly Drawings Chapter 7 Spare Parts 75 Figure 11 Assembly Drawing Sheet 5 Side Connector PCB Panel Label ...

Page 88: ...Assembly Drawings 76 Chapter 7 Spare Parts ...

Page 89: ...ree prong plug from the power supply or accessory to fit a two slot outlet If the outlet has only two slots make sure that it is replaced with a three slot grounded outlet before attempting to operate the monitor Warning SHOCK HAZARD Do not attempt to connect or disconnect a power cord with wet hands Make certain that your hands are clean and dry before touching a power cord Warning Use only patie...

Page 90: ...ment free of dust vibrations corrosive or flammable materials and extremes of temperature and humidity The unit should be kept clean and free of transducer gel and other substances Caution Do not operate the unit if it is damp or wet because of condensation or spills Avoid using the equipment immediately after moving it from a cold environment to a warm humid location Caution Never use sharp or po...

Page 91: ...ice is connected to the serial port a recorder or printer connected at the same time to the parallel port should be located outside the patient vicinity as the two interfaces are not isolated against each other Introduction This chapter contains maintenance and safety information for the FM 2 antepartum fetal monitor and its accessories All checks that require the instrument to be opened must be m...

Page 92: ...tallation The product is customer installed Refer to the Instructions for Use Visual and Power On Preventive Maintenance Preventive maintenance is limited to exchanging the battery Power On Safety Tests Repairs Unit Exchange Visual and Power On Unit opened Visual and Power On Front End Connector Board exchanged Power On Performance Tests for Trans ducers Safety Tests Rear Connector Board exchanged...

Page 93: ...P or V F Power On Self Test See 20 Power on the monitor Displays Normal Monitoring Screen Configuration and emits tones PO P or PO F Safety Tests Safety Test 1 See 86 Enclosure Leakage Current S F C Open Supply All Safety Test results are in range of Table 22 on page 87 S P or S F Safety Test 2 See 88 Patient Leakage Cur rent S F C Open Supply All Safety Test results are in range of Table 23 on pa...

Page 94: ...le is approximately 200 charge discharge cycles Low Power Warning A low power warning occurs when the battery power is running low The battery fuel gauge flashes and a repetitive audible tone sounds Remaining monitoring time is typically 30 minutes with a new battery at room temperature of 25o C In an older monitor in which the battery has had a number of recharge cycles it may occur when fewer mi...

Page 95: ...ly or 4 75 hours if no monitoring occurs Storing A stored battery loses capacity over time To minimize loss of capacity recharge the battery at least every six months A battery typically has three to five years shelf life Preventive Maintenance The only preventive maintenance task required for the monitor is battery exchange Life expectancy of a battery depends on the frequency and duration of use...

Page 96: ...s Test and Inspection Matrix in Table 21 tells you the expected results of the tests and what to record Warning Apply the safety test limits set by the local standards and statutes applicable to the country of installation such as IEC 601 1 UL2601 CAN CSA C22 2 No 601 1 M90 The safety tests defined in this chapter are derived from local and international standards but may not be equivalent They ar...

Page 97: ...he documentation included with those products When performing safety tests you must use a standard safety tester You can use testers complying with IEC 601 1 internationally You may also use testers complying with any local standards and statutes applicable to the country of the installation For safety test procedures see the operation instructions of the safety tester used If using the Metron saf...

Page 98: ...applicable to Class 1 and 2 equipment type B BF and CF Applied Parts The test measures leakage current of exposed metal parts of the Instrument Under Test It tests both normal and reversed polarity For type BF and CF Applied Parts the test measures AP GND Safety Test according IEC 601 1 Clause 19 Report the highest value Single Fault Condition S F C Open Supply This test is applicable to Class 1 a...

Page 99: ...lyzer to a fixing nut of the RS 232 connector on the back of the monitor 3 Turn the monitor on 4 Perform the test as recommended by the analyzer operating instructions The analyzer leakage current indication must not exceed the values listed in Table 22 Table 22 Enclosure Leakage Current Test Condition Polarity Maximum Leakage Current µA IEC 601 1 ES1 AAMI ANSI Standard Normal Normal 100 µA 100 µA...

Page 100: ... to earth power ground in parallel with one supply lead interrupted It tests both normal and reversed polarity Safety Test according IEC 601 1 Clause 19 Report the highest value Test Steps This test requires a sample patient cable for each device parameter These must be configured as recommended by the safety analyzer operating instructions 1 Configure the electrical safety analyzer as recommended...

Page 101: ...est consists of the Enclosure Leakage Current tests normal and single fault condition as described on 86 You must run this test when connecting either a new or repaired monitor Table 23 Patient Leakage Current Values Test Condition Polarity Maximum Allowable Leakage Current µA Type B BF Normal Normal 100 µA Reversed 100 µA S F C 1 Open Supply 1 S F C Single Fault Condition Normal 500 µA Reversed 5...

Page 102: ...aseline as follows a Highlight the Toco frame in the main monitoring screen by turning the navigation wheel b Press the wheel to enter the Toco Menu The existing Toco Baseline will be displayed c If you need to change this highlight the TOCO Baseline menu item and press the navigation wheel You will see a box containing the choices for setting the Toco Baseline d Highlight the desired Toco Baselin...

Page 103: ...arallel to the flat surface 8 The Toco display should read between 20 and 40 units above the Baseline Figure 12 Testing a Toco Transducer 9 If the test fails repeat with another transducer If it still fails refer to Chapter 5 Troubleshooting Toco display 5 10 15 or 20 depending on Baseline setting Toco display 20 40 Toco units above the Baseline ...

Page 104: ...nnect the transducer s to the US 1 or US 2 socket 3 Check that the display acknowledges the connected transducer s in the Ultrasound frame of the main monitoring screen 4 Increase the loudspeaker volume to an audible level 5 Holding the transducer in one hand move your hand repeatedly towards and then away from the surface of the transducer or gently tap the transducer surface with your finger Fig...

Page 105: ...sound Transducer 8 Holding the transducer in one hand move a flat bottomed pencil or similar object repeatedly towards and then away from each crystal The distance between the pen and the transducer surface should be about 2 to 3 cm Figure 15 Testing the Crystals in an Ultrasound Transducer 9 Check that a noise is heard from the loudspeaker for each crystal ...

Page 106: ...Testing Transducers 94 Chapter 8 Test and Inspection Matrix 10 If the test fails repeat using another transducer If it still fails refer to Chapter 5 Troubleshooting ...

Page 107: ...assembly 50 main PCB 49 navigation wheel 47 main PCB 59 side connector PCB 59 side panel 59 rear case foot cushions 58 handle 58 interface board 55 rear connector PCB 55 tools required 39 display removal 50 replacement 51 window removal 51 E electrical leakage 85 enclosure leakage current 81 87 error codes 23 8 most recent 28 explanation 23 error log 19 27 28 screen 28 errors 19 handling 22 not se...

Page 108: ...5 Nokia 6210GSM 15 modems supported 14 monitor block diagram 7 exchanging 2 general description 6 main assemblies See front and rear case assembly major component parts 38 mechanical description 8 overview of 6 mountings roll stand 10 wall mount 10 MultiTech 15 MultiTech MT 5600ZDX 17 N navigation wheel description 9 removal 47 replacing 48 Nokia 6210GSM 15 17 non medical equipment placement 14 18...

Page 109: ...main PCB 52 navigation wheel 48 main PCB side connector PCB 61 side panel 61 rear case rear connector interface PCB assembly 57 recorder cable 18 repair strategy 1 2 FM 2 Recorder 1 repairs battery exchanged 80 front end connector board exchanged 80 power supply exchanged 80 rear connector board exchanged 80 unit exchange 80 unit opened 80 roll stand 10 routine maintenance 11 RS 232 interface 13 m...

Page 110: ...faces 13 18 parallel 18 system safety test 89 T test and inspection matrix 19 77 94 expected results 81 introduction 79 reporting 81 test blocks power on self test 81 safety tests 81 visual test 81 when to perform 80 testing after repair 2 tests and error codes 19 Toco baseline set point power up defaults 25 Toco channel 10 Wheatstone bridge 10 tools 10 mm hex socket for encoder nut 47 for disasse...

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