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1. 1 Connect an SpO sensor to the monitor 2 Press the On Standby button to turn the monitor On 3 After the monitor completes its normal power up sequence verify that the sensor LED is brightly lit 4 Slowly move the sensor LED in proximity to the photo detector element of the sen sor Verify as the LED approaches the optical sensor that the LED intensity decreases 5 Open the sensor and take note that the LED intensity increases 6 Repeat Step 5 and the intensity again decreases This variation is an indication that the microprocessor is in proper control of LED intensity Y Turn the monitor to Standby LIFEGARD II Service Manual Dynamic Operating Range Test The following test sequence verifies proper monitor operation over a range of input signals Step Action 1 Press the On Standby button to turn the monitor on 2 Connect SpO simulator cable to the SpO adapter cable Connect the cable to the SpO patient monitoring input connector 3 Set the simulator as indicated in the table below Verify that the monitor readings are within the indicated tolerances Allow the monitor several seconds to stabilize the readings 4 Turn the monitor to Standby Table 6 1 Settings and Monitor Indications Simulator Settings Monitor Indications Ambient Ambient Light Light AC SpO Pulse Rate Freq Level Modulation SpO Pulse Rate 81 36 120 200 0 50 79 83 33 3
2. 9 2 LIFEGARD II Top Level Assembly Figure 9 1 9 1 LIFEGARD II Service Manual 9 3 Front Panel Assembly N Figure 9 2 1 of 2 Page Ref for Item No Part Number Description Disassembly 1 10 60023S 03 Main PC Board page 8 8 2 10 64708 01 Navigation Knob and Retainer Spring page 8 3 3 10 64660 01 Navigation knob bushing page 8 3 part of front case components Figure 9 3 2 of 2 9 2 9 4 9 5 Page Ref for Item No Part Number Description Disassembly 4 10 64655 01 Backlight Tube page 8 6 10 64707 01 Keypad page 8 3 10 64660 01 Speaker including speaker page 8 5 cable See front case kit components page 9 4 7 10 64654 01 Display Cables See display page 8 5 kit components page 9 4 8 10 64660 01 Bezel Protective Window No Disassembly Procedure Display See front case kit components page 9 4 9 10 64660 01 Front Housing See front case No Disassembly Procedure kit components page 9 4 Front Case Kit The Front Case Kit 10 64660 01 contains all the parts that comprise the front case or bezel except for the LCD display The table below calls out the contents Order 10 64660 01 Front Case Kit Quantity Description 1 Front case molded printed 1 Display window 1 LCD display bracket 1 Keypad 1 Navigation knob molded with retainer ring 1 Navigation knob bushing
3. Test or Inspection to Perform Maximum Leakage Current Patient Leakage Current AC lt 50 yA 250V IEC601 1 or UL2601 1 See Safety Test Diagram Patient Test at 11096 of the nominal line voltage Leakage Current AC on page 6 28 6 27 6 28 LIFEGARD II Service Manual Test or Inspection to Perform Not present in Class 2 Instrument under test L N o o 0 _ o o _ N L out Applied part S4 PEC Signal parti inand or 1 output 1 l Insulating pad L N ay N L __ and S6 Figure 6 5 Safety Test Diagram Patient Leakage Current AC Safety test according to EN60601 1 Clause 19 4 h Report largest value Measures patient leakage current from Applied Part to earth caused by external mains voltage on Applied Part with switch S5 open and closed Each polarity combination possible is tested using S2 7 1 7 2 7 3 Troubleshooting 7 Troubleshooting This chapter explains how to troubleshoot the monitor when problems arise Tables are supplied that list possible monitor difficulties along with probable causes and recom mended actions to correct the difficulty Use this chapter when you suspect you have a problem with your monitor or whenever you are referred to this chapter from another part of the Service Guide General Troubleshooting Safety Information W
4. 1 Connect the flowmeter inlet to the CO gas outlet 2 Connect the FilterLine to the CO module inlet Leave other end of line open 3 Block the inlet of the FilterLine using your fingertip and observe the cell pressure to the right of the slash symbol on the top row of the CO Test display screen The cell pressure should be more than 120 mmHg below the ambient pressure shown If the pressure difference is less than 120 mmHg the pump is not strong enough and should be replaced regardless of the Pump Op Time Flow Rate Check and Calibration Step Action 1 Connect the flowmeter to the CO FilterLine 2 On the flowmeter check the flow that the CO pump draws The nominal value is 50 the acceptable limits are 42 5 and 57 5 ml minute If the value is within these lim its proceed to the CO gas calibration check If not within the limits calibrate as fol lows 3 Select Flow Rate Check and Calibration Adjust the flow in the monitor by select ing Increase Flow or Decrease Flow until it is as close as possible to 50 ml minute as indicated on the flowmeter gauge The pump voltage displayed on the second row of the CO Test screen will vary as the flow is changed 4 When the flow is set as close as possible to 50 ml minute select Store Flow to confirm the setting NOTE If the adjusted flow is not stored within 60 seconds of the adjustment the old flow setting is restored If the fl
5. vug yO mov RS 232 Interface Figure 11 1 RS 232 Interface Pin connections for the 9 pin connector are as follows Pin Signal Direction 1 not used 2 Rx data input 3 Tx data output 4 DTR output 5 Signal Ground input output 6 DSR input 7 RTS output 8 CTS input 9 Alarm Out output Nurse Call Pin 9 of the RS 232 serial interface connector provides an Alarm Out signal Any time there is any alarm condition active in the monitor and if the Nurse Call Signal option in the Setup Menu is On pin 9 goes to plus RS 232 level voltage gt 5 VDC The alarm delay shall be lt 0 5 seconds If in the Setup Menu the Nurse Call Signal option is Off pin 9 is always at the minus RS 232 level voltage 5 VDC In order to make use of the Alarm Out signal pin 9 should be connected to a high impedance circuit 71000 2 and protected against tran sient voltages 11 2 Theory of Operation and System Architecture 12 Theory of Operation and System Architecture 12 1 General This section contains an overview of the theory of operation of the major functional modules of the monitor Analogic service providers that perform bench repair at the assembly level should review this high level information Please be aware that Analogic Life Care Systems Support Group only stocks assembly level parts Analogic does not recommend making changes 12 2 System Overview The monitor i
6. WARNING l Do not connect accessory equipment to the monitor s data interface if it is not cer tified according to the IEC 60950 for data processing equipment or IEC 60601 1 1 for electromedical equipment WARNING Route patient cabling to reduce the possibility of patient entanglement or strangu lation WARNING uN This monitor is not intended for use on neonatal patients WARNING i Do not place the monitor in any position that might cause it to fall on the patient Do not lift the monitor by the power supply cord or patient connections because disconnection could then result in the monitor dropping on the patient WARNING uN To ensure patient electrical isolation connect only to other equipment that pro vides patient electrical isolation WARNING N Do not use extension cords to connect the monitor to electrical outlets WARNING j Do not use the monitor during MRI magnetic resonance imaging scanning Induced current could potentially cause burns The monitor may affect the MRI image and the MRI unit may affect the accuracy of the monitor s measurements WARNING T To ensure optimal battery performance the monitor must be connected to AC power for 14 hours prior to first use of battery power Your monitor can be used during the charging time because the battery is still being charged even if the mon itor is turned on Safety WARNING Electromagnetic interference may cause disruptio
7. eee cece eens 12 3 12 5 NIBP Front End isses er Re bx RREeRER RERUPES 12 3 12 6 PowerSystem ar eor nen a E O A aA 12 3 12 7 Microprocessor Memory and Control 00 000 ee ee 12 3 12 57 DISDIay enero ea E nee ee en ae E A ee oe 12 3 12 9 Keypad sce ee Er baw Exe ERR Y ERA e Rs 12 3 12 10 Navigation Wheel 5 esa eere ee ER EX bodes 12 4 12417 R3 232 0 cette a aha quier Ree e esee 12 4 12 12 Speaker wc 2 cds eb RR mee ee RR Rs 12 4 12 13 USB Printer Interface eu cbr erre bRe TR ER Rhen 12 4 12 14 ReCORdGE euo Raus ede oe a hae ead arc du 12 5 12 15 ECG Processing 12 ecce Lee pete RC ec e d 12 5 12 16 ICG Processing serrie tror e SER apart Mie R oer eds 12 5 12 17 Respiration Processing 0 0 cee eee eee e 12 5 12 18 NIBP Processig 2 descen ep eee de Re 12 5 12 19 SPO Processing is cccncevaeio e REP E pee bed Rae Aedes 12 6 12 20 COs Processing os visas gre ehe ER e Ea e E 12 6 12 21 Temperature Processing sseeeeeee ene 12 6 13 0 Specifications 2 o oper e ter ICE A eR bet Mendon preda 13 1 13 1 General scies eene mee eR Rees 13 1 132 Hardware Specifications soeces mereinep en n enie e 13 1 13 3 Safety Standards i4 eiae T OP E EE a 13 1 134 Audible Alarms esee eee 13 2 135 HBlectrical oer erte er eb aaa EE 13 2 13 6 Environmental sseeeseeeeeee eee 13 3 13 7 Measuring and Displaying Parameters 0000 13 3 14 0 Technical Services a
8. 2 5 LIFEGARD II Service Manual WARNING f Inaccurate SpO measurements may be caused by Incorrect sensor application or use significant levels of dysfunctional hemoglobins such as carboxyhemoglobin or methemoglobin intravascular dyes such as indocyanine green or methylene blue exposure to excessive illumination such as surgical lamps especially ones with a xenon light source bilirubin lamps fluorescent lights infrared heating lamps or direct sunlight excessive patient movement high frequency electrosurgical interference and defibrillators venous pulsations placement of a sensor on an extremity with a blood pressure cuff arterial catheter or intravascular line the patient has hypotension severe vasoconstriction severe anemia or hypothermia e there is arterial occlusion proximal to the sensor ethe patient is in cardiac arrest or is in shock WARNING f Loss of pulse signal can occur in any of the following situations the sensor is too tight there is excessive illumination from light sources such as a surgical lamp a biliru bin lamp or sunlight a blood pressure cuff is inflated on the same extremity as the one to which an SpOs sensor is attached WARNING Correlation The EtCO readings do not always correlate closely with paCO val ues especially in patients with pulmonary disease pulmonary embolism or inap propriate ventilation WARNING N Do not measure EtCO
9. Power up Defaults Menu The purpose of the Power up Defaults Menu is to allow the authorized user to create a power up default for each setting in the monitor Power up defaults are the settings in effect each time the monitor is powered on Upon entering the Power up Defaults Menu physiological monitoring is terminated The screen layouts do not display any informa tion associated with normal monitoring operation After configuring the main monitoring screen and connecting the appropriate acces sories use the following procedure to configure the power up default settings for the monitor 5 1 LIFEGARD II Service Manual Step Action 1 From the main monitoring screen use the navigation wheel to highlight the Setup icon Press the wheel to select the icon 2 From the Setup Menu select Enter Power up Default Menu A popup box dis plays 3 Use the wheel to enter the passcode 21 5 Note This passcode is configured at the factory and CANNOT be changed 4 The Power Up Defaults Menu displays Factory defaults are shown in parenthesis POWER UP DEFAULT MENU Accept Current Settings Selected Audio Off Make Available Audio Off Make Available Auto Set Limits Make Available Audio Pause Period 180s Enter Diagnostic Mode Language English Enter Demo Mode Patient Data Units Metric Previous Trend Data Deny Access Low Priority Alarm Interval 4s or 15s Return The available menu items a
10. SpO Module Patient Monitoring I O Module Removing the Patient Monitoring I O Module Follow these instructions for removing the I O module from the Main PCB module Disassembly Step Action 1 Remove the following 2 screws to remove the connector module Screw 1 Screw 2 Note Use a flathead screwdriver to remove Screw 1 Slide the I O module out Disconnect the CO connector and tubing and the NIBP tubing Slide the CO exhaust tubing out Pull the I O module away Patient Monitoring 1 0 Module 8 9 LIFEGARD II Service Manual Removing the SpO Module After you have removed the Patient Monitoring I O module from the Main PCB mod ule you can remove the SpO module To do this Step Action 1 Remove the 2 screws fastening the SpO module to the I O module Screw 2 Screw 1 2 Remove the connector that attaches the SpO module to the I O module 3 Gently pull the SpO module away Removing the CO Module NOTE This procedure is only for Models AN4321P and AN4323P Step Action 1 Remove the 4 screws on the CO module Screw 1 Screw 2 Screw 3 Tilt the CO module towards the NIBP pump Gently pull the module away from the Main PCB module Note When reassembling the CO module ensure that the CO header matches up with the mating header Removing the NIBP Pump Disassembly Step Acti
11. 1 Encoder bushing 1 Speaker cable assembly 1 Speaker mesh grill 1 Cable tie 10 Machine screw SEMS PHCR 4 40 x 1 4 SS 5 Machine screw SEMS PHCR 4 40 x 3 8 SS 4 Washer FL No 4 SS 3 Washer No 4 0 375 OD TYP B RGLR S 1 Adhesive instant cyanoacrylate clear Display Kit The Display Kit 10 64654 01 contains all the parts required to replace the LCD dis play The table below call out the contents Order 10 64654 01 Display Kit Quantity Description 1 Display LCD color 640 x 480 10 4 in 1 Foam pad 1 8 x 0 5 x 1 0 in 1 Display cable assembly Note 2 Display connector pads Note Display cable can be ordered separately Order 10 64709 01 Display Cable Spare Parts 9 3 LIFEGARD II Service Manual 9 6 Rear Panel Assembly Figure 9 4 1 of 3 Black to Terminal Page Ref for Item No Part Number Description Disassembly 1 10 64664 01 Recorder Blanking Plate 8 4 1a 10 64656 01 Recorder 8 4 2 10 64658 01 AC Connector Power Entry No Procedure Displayed Module with Fuses 3 RS 232 Port Part of No Procedure Displayed Communication Board see page 9 5 4 Battery Housing Contained 8 3 in Chassis Kit see page 9 6 5 10 64657 01 Battery 8 3 6 Battery Cover Contained 8 3 in Chassis Kit see page 9 6 Figure 9 5 2 of 3 Page Ref for Item No Part Number Description Disassembly 7 10 64663 01 Side Panel
12. o lzecsu suoi ped ay Aejdsiq X 19MO0dg qe M peg wW3IS 19MOd Aninag J01ju0 pue Mow w qi e npoj 02 pug 1u014 j 09 9 npo N daiN pu3 juoly 3 dgIN Anin211 odg pue dwa 991 dsay 993 pug yuoly 3 zods lt gt dwa 192I pajejos r uau Iy C dS13U 933 pee7 Figure 12 1 System Block Diagram 12 2 12 4 12 5 12 6 12 7 12 8 12 9 Theory of Operation and System Architecture Isolated Front End The Isolated Front End section includes all of the circuitry to convert ECG ICG SpO and Temperature measurements to digital format and to connect this information to the processor The Respiration detection is obtained from two of the three electrodes of the ECG connections NIBP Front End The NIBP section contains the pumps valves pressure measurement circuitry and con trol circuitry for the non invasive blood pressure measurement Pressure data is convert ed to digital format and conveyed to the processor section Power System The power system section contains a power supply capable of operating the monitor and charging the battery from an AC source of 100 to 240 VAC at 50 to 60 Hz The battery provides the operating power Microprocessor Memory and Control The Microproc
13. see page 7 5 What to do if the monitor cannot be switched on battery powered Step Action 1 Plug the monitor into an AC power source 2 Ensure the battery has had ample time to charge at least 15 minutes A dead bat tery will prevent the monitor from powering On 3 The monitor should either be returned to the factory see Section 14 or opened to isolate the defective component see page 7 5 Troubleshooting 7 5 Part 2 Isolating and Solving Monitor Problems Technical Alarm Messages The following table explains the technical alarm messages that the monitor can issue and suggests a course of actions When actions are numbered always try them in the order given and only proceed to the next action if the current one is not successful in solving the problem Message Cause of Failure Remedy CO Equip Malfunction in the CO hard Verify failure and replace Extension with a known Malfunction ware good Extension CO No Tubing The FilterLine is disconnected Attach a FilterLine Remember that only Microstream or an incorrect line is attached accessories may be used with the monitor CO Sensor Warm up The sensor has not reached operating temperature Allow the sensor to warm up CO Occlusion The FilterLine or exhaust tube is blocked to the extent that a measurement sample cannot be taken The outlet is occluded at Power On T
14. 6 8 Volume Control Test 6 9 Preventive Maintenance Tests NIBP 6 9 Performance procedures Battery Performance Procedures 6 14 Temperature Test 6 16 ECG Performance 6 16 Respiration Performance 6 17 SpO Performance 6 18 CO Performance 6 19 Serial Interface and Nurse Call Signal Test 6 24 Patient Safety Tests S 1 Ground Integrity 6 25 S 2 Electrical Leakage 6 26 S 3 Earth Leakage Current 6 26 S 4 Enclosure Leakage Current 6 27 S 5 Patient Leakage Current 6 27 S 6 Patient Leakage Current with Mains 6 28 Testing the Monitor 6 5 Recommendations for Testing Frequency Perform the procedure as indicated in the suggested testing timetable These timetable recommendations do not supersede local requirements See Testing Checklist para graph 64 NOTE All performance tests should be performed with a fully charged battery Suggested Testing Frequency Functionality Assurance Performance Assurance Test Power On Self Test When functional defects in the measurements are suspected after any repairs if the monitor has been dropped or opened Preventative Maintenance Tests NIBP Every year or as needed Performance Tests Battery Performance Temperature Accuracy ECG Performance e Resp Performance SpO Performance CO Performance Serial Interface and Nurse Call Signal Test The battery performance test must be performed every two years before monitor repairs or wh
15. AN4321P AN4323P page 8 10 10 1 10 2 10 3 Packing for Shipment 10 Packing for Shipment This chapter explains how to pack the monitor for shipment General Instructions To pack the monitor for return disconnect all cables It is not necessary to return sen sors patient cables NIBP tubing and cuff or power cord Pack the monitor carefully Failure to follow the instructions in this section can result in loss or damage not covered by the warranty If the original shipping carton is not available use another suitable car ton Prior to shipping the monitor contact the Analogic Life Care Systems Support Group for a Returned Material Authorization RMA number mark the shipping carton and any shipping documents with the RMA number Repacking the Original Carton If available use the original carton and packing materials Pack the monitor as follows Step Action 1 Place the monitor and if necessary accessory items in original packaging 2 Close the shipping carton and seal with packaging tape 3 Label carton with shipping address return address and RMA number if applicable Repacking in a Different Carton If the original carton is not available use the following procedure to pack the monitor Step Action 1 Place the monitor in a plastic bag 2 Locate a corrugated cardboard shipping carton with at least 200 pounds per square inch
16. Humidity Limits Temperature Limits Keep out of Sun Keep Dry Fragile Keep Upright AC LED NEN Battery LED ace NIBP L D Artery Location for Cuff zu Volume Contrast I O On Standby Snapshot Continuous v Defibrillator proof Type CF Equipment ECG Audio Alarm Control Button T Temperature SpO SpO Ris NIBP EtCO End Tidal Carbon Dioxide Safety 2 13 LIFEGARD II Service Manual Figure 2 1 Explanation of Symbols continued NIBP Automatic Interval Mode Symbol Description co Cardiac Output Cl Cardiac Index SVR Systemic Vascular Resistance SVRI Systemic Vascular Resistance Index TFC Thoracic Fluid Content ACI Acceleration Index SV Stroke Volume SI Stroke Index A Alarm Label AC LED X Audio Off d Large Numbers Clock Up Alarm Arrow Limit Down Alarm Arrow Limit LT Battery Status Icon SpO Perfusion Indicator Bar ICG Signal Quality Indicator Heart Rate Entering Stand by Please wait Heart Rate taken from ECG Heart Rate taken from NIBP Electrostatic sensitive Figure 2 1 Explanation of Symbols continued Symbol Description Heart Rate taken from SpO Respiration from impedance ECG aw RR Respir
17. Increase Flow After desired flow rate is obtained select Store Flow Highlight and press Return to exit popup menu CO Calibration Displays the date and time that the last calibration occurred To calibrate COs you must follow the procedure outlined on page 5 22 Pump Op Time Displays the length of time that the pump has been operational A CO Calibration Required message will appear in the message frame after the first 1 200 hours of operation or after 12 months whichever comes first Thereafter it will occur every 4 000 hours of operation or after 12 months whichever comes first See CO Gas Measurement Calibration Check in Section 5 After 20 000 hours of operation the monitor MUST BE RETURNED to the factory for maintenance Pump Op Time can only be reset to Zero at the factory and only after required maintenance Return Exits the CO Test and returns to the Diagnostic Menu 5 9 LIFEGARD II Service Manual Restoring Factory Settings Caution N In addition to restoring factory defaults this procedure clears the contents of trend memory The following technique can be used to restore the monitor s power up default setting which were originally configured in the factory NOTE Before performing the first step read this procedure COMPLETELY Step Action 1 Ensure that the monitor is powered Off 2 Simultaneously press the Volume and Contrast buttons o
18. Introduction The measurement parameters and features for each model are indicated below Model Description Parameters Printout ECG NIBP Temp SpOo Respiration EtCO5 Hemo Recorder USB Printer Interface AN4320 Basic v AN4320P Basic w recorder AN4321P Basic w EtCO AN4322P Basic w ICG AN4323P Basic w EtCO amp ICG NSIS SENSES SESE NYS ST SION S NESE NEN ATSI STS SESE SIS 1 5 Front Panel Description The following diagram illustrates the controls located on the LIFEGARD II front panel ft D 353 E 0 D E Callout Description A AC LED B Battery LED C Audio Alarm Control Button D NIBP Button E Volume Button F Contrast Button G On Standby Button LIFEGARD II Service Manual 1 6 Front of Monitor Use the following diagram to familiarize yourself with the main features of the LIFE GARD II monitor The recorder module and all patient input connectors are located on the monitor s side panels erc e ie T c 37 8 Adult 01 06 03 01 09 17 Callout Description A Patient Monitoring Input Connectors B Main Monitoring Screen C Handle D Recorder optional feature E Navigation Wheel Patient Monitor Connectors All the patient input connector
19. Ring This ring is a single use part that will become damaged during removal It is strongly advised to purchase and have on hand the Small Parts Kit part number 10 64659 01 see page 9 1 before starting the reassembly process 8 3 LIFEGARD II Service Manual Removing the Recorder Models AN43XXP only Step Action 1 Press the external Paper Eject button on the right hand side of the recorder The door drops forward 2 Remove the paper roll Two captive screws are visible on the back panel of the recorder 3 Use a Philips 2 screwdriver to loosen the two captive screws 4 Pull the recorder straight out of the side of the monitor by placing your index and middle fingers in the inside center of the recorder and firmly pulling the recorder toward you Separating the Front from the Rear Case Step Action 1 Verify that the battery has been removed If not see Removing the Battery on page 8 3 2 Verify that the navigation wheel and brass bushing have been removed If not see Removing the Navigation Wheel on page 8 3 3 Use a Philips 2 screwdriver to remove the 6 screws fastening the Rear Case Assembly to the Front Case Assembly NOTE The top 2 screws adjacent to the handle are 1 2 long and the 4 remaining screws are 1 long 4 Facing the front of the monitor shift the front case slightly to the right making sure that you do not break off the navigation wheel s encoder sha
20. The monitor and its accessories must be tested by qualified service personnel at regular intervals to verify proper operation according to the procedures of the user s institution Warnings Cautions and Notes The precautions are grouped into two 2 main categories WARNINGS and CAUTIONS In addition the manual highlights Notes of significant information relevant to the monitor display operator instruction or operator action being described in the text Warnings advise against certain actions or situations that could result in personal injury or death Cautions advise against actions or situations that could damage equipment produce inaccu rate data or invalidate a procedure Notes provide useful information regarding a function or procedure 2 1 LIFEGARD II Service Manual 2 2 2 3 Warnings The following are warnings that define precautions that must be observed to avoid injury to personnel Some of these precautions are specific to particular operator actions They will appear in the text Others may be of a general purpose nature and may not be duplicated in the many places in which they may be relevant WARNING A Explosion Hazard Equipment not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide WARNING Electric Shock Hazard Covers should be removed only by qualified service per sonnel There are no user serviceable parts inside
21. Verify that the battery icon displays at the bottom of the display Note the time At least one segment of the battery icon should be filled 7 Keep the monitor on for three hours or until the low battery technical alarm occurs If the technical alarm has not occured the monitor has passed and the battery must be recharged 8 If the technical alarm occurs record the time and continue testing As the battery ages this time will become shorter If the loss of monitoring alarm has not occured the monitor has passed and the battery must be recharged 9 If the loss of monitoring alarm has occurred or if the monitor has automatically shut down prior to three hours it is recommended that the battery be replaced See Removing the Battery on page 8 2 Press any front panel button on the moni tor to terminate this alarm Temperature Test The accuracy of the monitor s temperature measurements is 0 1 C 0 2 F In the pro cedure below add the tolerance of the simulator to the acceptable range of readings Tools Needed Fogg System TP400 Temperature Probe Simulator or equivalent Fogg System 7242 0001 Cable 1 4 to 1 4 3 conductor NOTE The instructions below apply to the Dynatech Nevada MedSim 300 Step Action 1 Verify the monitor is in Standby Connect the temperature cable to the appropriate connector on the temperature simulator 2 Connect the temperature cable to the Temperature
22. Volume button to ensure that both valves are closed 5 Perform an offset adjustment so that the simulator and monitor both display a pres sure of 0 mmHg or kPa by doing the following a Press the Contrast button on the monitor s front panel b If needed zero the simulator see To Zero the Simulator on page 6 10 6 Note Complete steps 6 9 within 150 seconds Press and hold the NIBP button on the monitor s front panel and inflate to 250 10 Don t go over 270 or safety deflation may occur Slow the inflation rate by pulsing the button when the pressure is over 200 7 Allow 15 20 seconds for the pressure to stabilize 8 Press and hold the Alarm off button on the monitor to release the pressure in steps of 3 mmHg 4 kPa Simultaneously start the timer 9 Stop the timer when the pressure drops below 150 mmHg 20 kPa Calculate the deflation rate X5 starting pressure 150 of seconds The deflation rate should be 3 3 mmHg s 1 5 mmHg s 0 44 kPa s 0 2 kPa s 10 Press and hold the Volume button until the monitor displays a pressure of O mmHg or kPa 11 If no further NIBP tests are to be conducted turn the monitor Off Normal monitoring operation returns the next time the monitor is turned On LIFEGARD II Service Manual 6 14 Basic Pneumatic Leakage BPL Test The purpose of this test is to verify the integrity of the NIBP pneumatic system after the monitor has been opened This includes a
23. active and displays Leak Test 4 Press the Volume button to ensure that both valves are closed 5 Perform an offset adjustment so that the simulator and monitor both display a pres sure of 0 mmHg or kPa by pressing the Contrast button on the monitor s front panel 6 Press the NIBP button on the monitor s front panel to activate the pump Hold the button until the monitor displays a pressure of approximately 250 mmHg 33 3 kPa 7 Allow 15 20 seconds for the pressure to stabilize Record the pressure displayed on the monitor 8 Start a one minute time After one minute record the pressure displayed again The pressure should drop by no more than 6 mmHg 0 8 kPa during the one minute 9 Press and hold the Volume button until the monitor displays a pressure of 0 mmHg or kPa 10 If no further NIBP tests are to be conducted turn the monitor Off Normal monitoring operation returns the next time the monitor is turned On Inflation Rate Test This test verifies the inflation rate of the monitor Step Action 1 Turn the simulator On 2 Perform the following sequence a Press the Home button b Press the Pressure Tests button c Press the Pressure Leak Test button d Press the Setup button e Press 3 0 0 then Enter f Set the Cuff to Internal Press the Volume button to ensure that both valves are closed Perform an offset adjustment so that the simulator and monitor both display a
24. cover The LIFEGARD II Service Manual contains all the information needed to support the LIFEGARD II monitor for the service diagnosis removal and replacement of field replaceable parts This Service Manual supports Monitor Software Version 1 xx If the software version of your produce is not in the range from 1 00 to 1 99 please con tact your sales representative to obtain addendum pages or a replacement manual that describes the operation of your version of the product The monitor s software revision number can be located during the boot up sequence in the lower center of the screen TABLE OF CONTENTS 1 0 InttOdUCUlOR 5 5 4 5 eter err RR CR Re ER RERO Roc dig ey dase de 1 1 1 1 General Safety Information 0 0 0 eee eee 1 1 12 General serei errori a EORR eb REPRE a beeen dee Ge eka 1 1 13 LIFEGARD II Patient Monitor Description 4 1 1 14 Features and Options 0 00 cece eect eens 1 2 15 Front Panel Description 2 sscceerbext gp ere Gece de PRSE ae 1 3 1 6 Front of Monitor 20 06 045 eee e ee ehh etes 1 4 L7 Rear Of Mo itot 04 056 d444 ead sn v s e YR Ri exe 1 5 L8 Screen Display i eia tori aot ec be Eure atin 1 6 19 Additional Documentation 0 0 eee eee 1 6 20 Salen hits add naa ree DR Hy ea Pet teed GC NEWER ACER Uns 2 1 2 l Proper Use ue see Eae ex e hey ao do aes 2 1 22 Warnings Cautions and Notes 0 cee eee eee eee 2 1 23 Wamings des
25. in the presence of pharmaceuticals in aerosols WARNING Danger explosion hazard Microstream measurement should not be used in N the presence of flammable anesthetics such as Flammable anesthetic mixture with air Flammable anesthetic mixture with Oxygen or Nitrous Oxide WARNING EtCO values for non intubated patients using Microstream accessories always N tend to be lower than for intubated patients If values appear extremely low check whether the patient is breathing through the mouth or whether one nostril is blocked WARNING N Use only Microstream accessories to ensure correct functioning of the EtCO Microstream measurement Safety WARNING When using the Microstream EtCO measurement on patients who are receiving or have recently received anesthetics the outlet must be connected to a scaveng ing system or to the anesthesia machine ventilator to prevent exposure of medical staff to anesthetics WARNING i Do not re use clean or sterilize Microstream EtCO accessories as they are intended for single patient one time use WARNING M Use only Analogic recommended blood pressure tubing and cuffs Using other cuffs or tubing can result in inaccuracies WARNING N Do not use the monitor on patients who are linked to heart or lung machines WARNING M The monitor cannot operate effectively on patients who are experiencing convul sions or tremors WARNING i In
26. min For respiration rate above 80 bmin the accuracy com plies with EN 864 ISO 9918 4 mmHg or 12 of indicated value whichever is greater for End tidal CO values exceeding 19 mmHg The above accuracy is maintained to within 4 for the following gas mixtures CO 0 13 N2 0 97 5 O2 0 100 N2O 0 80 H2O Dry to saturated awRR Parameter Specification Range 0 to 150 breaths min Accuracy 0 to 41 breaths min 1 breaths min 41 to 70 breaths min 2 breaths min 71 to 100 breaths min 3 of reading gt 100 breaths min 5 of reading 13 7 LIFEGARD II Service Manual 13 8 ICG Parameter Specification ICG Measurement technique TEB thoracic electrical bioimpedance Number of Electrode pairs 4 Excitation Current 1 mA RMS 10 Excitation Frequency 76 8 kHz 0 01 Basic Thoracic Impedance Range 0 600 Basic Impedance Measurement Bandwidth 0 10 Hz Impedance Variation Range 10 Impedance Noise 1 mO at 500 basic impedance Patient Criteria Height 4 ft 7 ft 6 in 122 229 cm Weight 67 350 Ib 30 159 kg Trends Parameter Specification Type Graphical and tabular Memory Storage 12 hours nonvolatile Data interval Graphical Trend Format Display range Vertical scaling 20 seconds stored data points is the average over 20 second interval One graph per vital sign 2 hours scro
27. objectives you should be able to perform light mainte nance and preventive maintenance for the monitor through the following tasks Inspection of the monitor Cleaning of the monitor Battery Maintenance 4 4 Concepts Light Maintenance Light maintenance tasks can be defined as those tasks required to maintain the monitor in clean functional working order These include inspection cleaning practice and bat tery maintenance as well as the continuous observation of replaceable parts for wear 4 1 LIFEGARD II Service Manual 4 2 4 5 Recommendations for Maintenance Frequency The following table is the recommended maintenance schedule for the LIFEGARD II patient monitor The maintenance checklist appears in the next section of this chapter The checklist may be photocopied and should be completed by the maintainer It should be filed for future reference The owner of the equipment is responsible for the perfor mance of the maintenance activities with the schedule below Maintenance Frequency Procedure Inspect the monitor cables Daily Inspecting the Monitor on page 4 3 and and cords Inspecting the Cables and Cords on page 4 3 Cleaning As needed Cleaning on page 4 3 Safety checks according to IEC 60601 1 At least once every 2 years after any repairs if the monitor has been dropped or as needed Patient Safety Tests on page 5 25 Functional testing procedures When functional defe
28. performed in the same session Barometric Pressure Check and Calibration Check the barometric pressure value in the CO2 module as follows Step Action 1 Enter the Power Up Defaults Menu see Power Up Defaults Menu on page 6 2 for instructions on accessing this menu Select the Enter Diagnostic Mode option From the popup menu select Yes The Diagnostic Menu displays Select the CO Test option oj AJ Oj N Connect a FilterLine to the CO patient monitoring input connector This activates the pump in the CO module 6 Check the status line at the top of the screen It will display CO pressure in mmHg ambient cell xxx yyy where xxx is the ambient pressure and yyy is the measured cell pressure The values are displayed with a resolution of 2 mmHg 0 3 kPa up to 475 mmHg 63 2 kPa and a resolution of 1 mmHg 0 1 kPa from 475 mmHg 63 2 kPa to 825 mmHg 109 7 kPa Check whether the ambient pressure match es within the acceptable tolerance of 12 mmHg the reference value you have received If so proceed to the Leakage Check If the value is not correct calibrate as follows 7 Select Set Barometric Pressure mmHg An adjustable value in mmHg is activated 8 Select the value that matches the reference value received from a reliable local Source such as an airport regional weather station or hospital weather station 9 If the selected value is not within x12 mmHg 1 6 kPa of t
29. psi bursting strength Fill the bottom of the carton with at least 2 inches of packing material Place the bagged unit on the layer of packing material and fill the box completely with packing material Seal the carton with packing tape Label carton with shipping address return address and RMA number if applicable 10 1 RS 232 Interface 11 RS 232 Interface This chapter explains how to properly use and connect the RS 232 interface and cables 11 1 General RS 232 Safety Information WARNING Do not place the monitor in any position that might cause it to fall on the patient Do not lift the monitor by the power supply cord or patient connections because disconnection could then result in the monitor dropping on the patient WARNING AN If you connect the monitor to any instrument verify proper operation before clinical use Refer to the device s manual for full instructions Accessory equipment connected to the monitor s data interface must be certified according to IEC Standard 950 for data processing equipment or IEC Standard 60601 1 for electromedical equipment All combinations of equipment must be in compliance with IEC Standard 60601 1 system requirements Anyone who connects additional equipment to the signal import port or signal out put port configures a medical system and is therefore responsible to ensure that the system complies with the requirements of IEC Standard 60601 1
30. the battery for at least 8 hours The battery may require a full discharge charge cycle to restore it to its normal capacity 4 To check for a full charge perform the procedure described in Battery Performance Test on page 5 14 4 5 LIFEGARD II Service Manual Battery INOP Messages The following battery related INOP message is issued by the monitor The Battery INOP will continue until the monitor is plugged into the AC power or the INOP condi tion is fixed Low Battery This is an INOP which indicates that the remaining battery operat ing time is less than approximately 30 minutes 4 6 5 1 5 2 Configuring the Power up Defaults Menu 5 Configuring the Power up Defaults Menu This chapter discusses the use of the Power up Defaults Menu to configure power on default settings It also explains how to use Diagnostic Mode to obtain service related information about the monitor General Safety Information WARNING A blood pressure cuff connected to the monitor should never be applied to a human being while the monitor is in Diagnostic Mode Injury could result A FilterLine connected to the monitor should never be applied to a human being while the monitor is in Diagnostic Mode Injury could result Caution 1 In addition to restoring factory defaults this procedure clears the contents of trend memory NOTE Before performing the first step read this procedure COMPLETELY
31. the crevice between the LCD screen and where the backlight tube slides in 2 Using the screwdriver grab the corner of the backlight tube and gently pull the tube out Re insert a new backlight tube Rear Case Disassembly You must disassemble the rear case to remove the following modules Main PCB Patient Monitoring I O SpO CO NIBP Communications Power Supply Caution N Before you remove any module make sure you are wearing ESD protection and you are working in a grounded environment Disassembly To disassemble the rear case Step Action 1 Verify that the battery has been removed If not see Removing the Battery on page 8 X 2 Verify that the recorder has been removed If not see Removing the External Recorder on page 8 X If there is no recorder unsnap the recorder door using a flat head screwdriver see figure below 3 Use a Philips no 2 screwdriver to remove the 9 screws fastening the rear case 4 Screw 1 Screw 2 5 Gently slide the chassis away from the rear case LIFEGARD II Service Manual Removing the Main PCB Module Step Action 1 Unscrew the PCB module by loosening the following 3 screws Screw 1 Screw 2 Screw 3 2 Gently pull the module towards you 3 After you have removed the Main PCB module you should have access to the CO SpOs NIBP pump and the Patient Monitoring I O modules
32. 1 If in doubt consult with the Analogic Life Care Systems Support Group or your local Analogic representative Caution A Connection to a battery operated PC should only be allowed by the end user Connection to a line powered device with an ITE Class II power supply is accept able provided it passes all 60601 1 1 tests without a problem If there is a line powered device with a Class power supply such as a line pow ered PC or a printer in the system there must be either optical isolation of the data cable or the Class devices must have isolated transformers NOTE The monitor and its accessories must be tested by qualified service personnel at regular intervals to verify proper operation according to the procedures of the user s institution Additional important safety information can be found in the LIFEGARD II Operator s Manual 11 2 The RS 232 Interface The RS 232 interface enables you to send a nurse call signal export trend data to an external PC Cable Connections A 9 pin connector mounted on the rear panel provides the access port for the serial RS 232 interface to a suitably configured personal computer Or alternatively quali fied service personnel can use the connector to send a Nurse Call signal The following figure shows the location of the RS 232 interface on the monitor 11 1 LIFEGARD II Service Manual oo00roo C OG AN ANALOGICJM LIFEGARD I
33. 500 Hz and 3125 Hz harmonics gt 45 dBa and lt 80 dBa Medium Priority Alarm 2Low Priority Alarm Medium Priority Alarm Frequency Component 550 Hz base frequency 1100 Hz 1650 Hz 2200 Hz and 2750 Hz harmonics Sound Pressure Frequency Component Low Priority Alarm Physiological gt 45 dBa and lt 80 dBa sHigh Priority Alarm 2Low Priority Alarm 450 Hz base frequency 900 Hz 1350 Hz 1800 Hz and 2250 Hz harmonics Sound Pressure gt 45 dBa and 80 dBa lt High Priority Alarm Medium Priority Alarm 13 5 Electrical Parameter Power Sources Internal Battery Battery Operating Time AC Mains Specification 12 volt 4 5 Ah sealed lead acid 3 hours fully charged battery at 25 C with out EtCO under normal conditions one NIBP measurement every 15 minutes all other modes active 45 minutes if printing continuously 1 hour fully charged battery at 25 C with EtCO under normal conditions 30 minutes if printing continuously 100 to 240 VAC 50 60 Hz 1 A max Specifications 13 6 Environmental Parameter Specification Mechanical Shock IEC 60068 2 27 100g 6 ms 3 axes 18 total shocks non operating Mechanical Vibration IEC 60068 2 6 Sinusoidal 10 58 Hz 0 15 in displacement 58 150 Hz 2g accelera tion 4 min sweep 20 sweeps axis non operating Water Resistance IEC 60529 Classification IPX1 Protected
34. 9 81 112 120 200 5 0096 79 83 109 115 81 2018 120 10 0 5096 79 83 195 207 81 2018 120 200 5 0096 79 83 195 207 An indicates values that produce an alarm Press the Alarm Silence button to tem porarily silence the audible alarm a For the pulse rate setting of 201 BPM the pulse rate tolerance of 195 to 207 BPM is greater than x3 BPM accuracy specification on the monitor due to the performance characteristics of the simulator CO Performance This test checks the performance of your CO measurement for the monitor This test uses calibration equipment that can be ordered See page 6 5 Refer to the documenta tion accompanying the equipment for detailed instructions The procedure is summa rized in the following steps Barometric Pressure Check and Calibration if required Leakage Check Pump Check Flow Check and Calibration if required CO Cal Check and Calibration if required NOTE Allow 5 seconds between individual service procedures in order to ensure stable equipment conditions Testing the Monitor Tools Needed for CO Tests Electronic Flowmeter Tubing CO Patient Connector e Cal 1 gas 5 CO Also needed is a local barometric pressure rating received from a reliable source such as an airport regional weather station or hospital weather station The pressure rating must be located at the same altitude as the hospital NOTE All steps must be
35. ARNING i Do not attempt to troubleshoot the monitor if there is any sign of burning or smok ing coming from the monitor Call the Analogic Technical Support Services or your local Analogic representative immediately Caution T Only qualified service personnel should open the monitor housing remove and replace components or make adjustments If your medical facility does not have qualified service personnel contact the Analogic Technical Support Services or your local Analogic representative Objectives In order to meet this chapter s objectives you should be able to diagnose and isolate hardware failures to the level of the field replaceable part In addition this chapter describes how to troubleshoot problems using error codes This chapter is divided as follows Part 1 Troubleshooting Checklist Provides checklist for hints and tips Part 2 Solving Monitor Problems Provides the following Tables listing monitor symptoms as well as causes and remedies Techniques for troubleshooting the monitor before disassembling it Checks to perform to isolate problems down to a specific replaceable part for exam ple the power supply Part 3 Using Support Functions Provides information on using error codes as a sup port feature Concepts Troubleshooting This is the essential diagnostic step to be taken prior to any repair Error Codes These are the types of messages that generate and display to infor
36. LIFEGARD II Patient Monitor SERVICE MANUAL ANALOGICE e World Resource for Health amp Security Technology LIFEGARD II Patient Monitor Service Manual Model AN4300 Analogic Corporation Life Care Systems Division 8 Centennial Drive Peabody Ma 01960 978 977 3000 or 978 326 4000 CE Marking Europe The following product and accessories from Analogic Corporation carry the C mark to Council Directive 93 42 EEC 0197 CE Product AN4320 AN4320P AN4321P AN4322P AN4323P Accessories from other companies other than Analogic Corporation carry CE markings appropriate to the accessory Authorized EU representative Villy Braender Mileparken 34 2730 Herlev Denmark Tel 45 44 52 8100 Fax 45 44 52 8199 United States Caution United States Federal Law restricts this device to sale by or on the order of a physician Oximax NELL 1 MaxFast Durasensor Oxiband Oxicliq Pedi check satSeconds C Lock are trade marks of Nellcor Microstream FilterLine SmartCapnoline are trademarks of Oridion HyperTerminal is a trademark of Hilgraeve Inc The LIFEGARD II s embedded software and Oridion s Microstream software is protected by United States copyright laws and international treaty provisions Except as otherwise expressly permitted hereby you may not reverse engineer decompile or disassemble the software Made in U S A Analogic Part Number 16 00261 01 Rev 00 Preface LIFEGARD II Service Ma
37. Menu the operator is prompted to turn off the monitor to save any changes that were made Configuring the Power up Defaults Menu Error Codes DIAGNOSTIC MENU ERROR CODES Error Codes Date Time ds 2 3 4 5 6 T 8 9 10 Return This screen displays the 10 most recent error code types logged by the monitor The date and time that the error code appeared displays to the right of the error code Error codes cannot be changed or reset in this screen When in the Error Code screen the Return option is always highlighted Press the wheel to return to the Diagnostic menu Rotating the navigation wheel while in the Error Code screen has no effect Refer to Error Code Categories on page 7 9 for more details on error codes System Information DIAGNOSTIC MENU SYSTEM INFORMATION Monitor On Time Backlight On Time Recorder On Time Battery Deep Discharges O OOOO System Software Version Application VX XX CO Software Version 00 01 NL V01 11 09 05 2000 SN 10971 SpO Software Version NELLCOR MP100 1 4 0 0 03 08 04 NIBP Software Version LM3 386 SM V219 a 123456 Cycle 369 Return When in the System Information screen the wheel can be rotated to select any of the changeable items If one of those items is selected a press of the wheel displays a popup menu The first item is Make No Change the second item is Reset to Zero 5 5 LIFEGARD II Service Manual This screen displays se
38. Menu is immediately exited and you are instructed to power down the monitor a Although the language choices are shown here in English they display on the screen in their respective language and script on the Boot Up screen and in the Power up Defaults Menu LIFEGARD II Service Manual Diagnostic Mode The purpose of the Diagnostic Mode Menu option is to allow factory field service and hospital biomedical technicians access to a series of test and system related information screens for the purpose of verifying monitor performance or troubleshooting problems To access Diagnostic Mode Step Action 1 Enter the Power up Defaults Menu see Power up Defaults Menu on page 5 2 for instructions on accessing this menu 2 Select the Enter Diagnostic Mode option 3 From the popup menu select Yes The Diagnostic Menu displays DIAGNOSTIC MENU Error Codes System Information System A D Values NIBP Test CO Test AN4322P and AN4323P models Return The Diagnostic Menu lists the test and system related information screens Select an item in the menu to invoke a test or information screen The test and information screens that are in the diagnostic menu are listed below An explanation of each menu is given in the sections that follow Error Codes e System Information e System A D Values NIBP Test CO Test AN4322P and AN4323P models When entering Return in the Diagnostic
39. Safety Information 0 00 eese 8 2 84 Disassembly Procedures 0 0 c cece eee eee 8 2 8 4 1 Closed Case Disassembly Procedures 044 8 2 9 0 Spare Parts 9 1 9 Smal Parts Kit panas ao E a CREAR ES 9 1 92 LIFEGARDII Top Level Assembly 000 4 9 1 93 Front Panel Assembly 00 c cece eee es 9 2 94 Front Case Kit 2 4 ssa castes e d en ea eee 9 3 95 Display Kit oct asda eee ees teva inde tan edd 9 3 96 Rear Panel Assembly 00 0 60sec eee eee eee 9 4 97 RearCase Kit o occriricisss eee e ee b eee rera 9 6 9 5 Chassis Case Kit cere x es bene Re REE erac RIS 9 6 99 Additional Spare Modules 00 eee 9 6 10 0 Packing for Shipment 00 ccc eee eee nee 10 1 10 1 General Instructions 0 0 ee eee eee 10 1 10 2 Repacking the Original Carton llle ee eee ee 10 1 10 3 Repacking in a Different Carton 0 cece ee eee 10 1 TOR S22 32 Inietiage aici cc sae ts denen x d baad on S auch sets 11 1 11 1 General RS 232 Safety Information 00 000000 11 1 11 2 The RS 232 Interface sericea bea sheared Ree peer e rex ed Bes 11 1 12 0 Theory of Operation and System Architecture 0 0 00005 12 1 12 1 General ies e Rem ee ee ERR 12 1 122 System OYerview sar harearri eae eR CREE eR eR e 12 1 12 3 Block Diagram 5 iis et ERERRIRRHRO tig eek ERU 12 1 12 4 Isolated Front End 0
40. a eR RRPCRRROUE ease ERR ER ERE ede 2 2 300 Site Preparations 1useesek epe daa ee eR en ede OR UR Een epos 3 1 Sal General js iere pere E Para a E A ph ogi bbes 3 1 32 General Site Preparation Safety Information 3 1 33 Site Preparation Guidelines sllseleeeeeeeeeeees 3 2 34 Safety Precautions 0 ccc cece eee eens 3 2 35 Preparing to Use the Monitor 0 0 cece eee eee eee 3 2 3 6 Monitor Disposal i e obe erect ei e eg e bps 3 3 37 Unpacking the Monitor 0 0 eects 3 3 3 8 Checking the Shipment 20 0 cece cece eee eee 3 3 39 Returning System Components 0 0 0 eee eee ee eee 3 4 40 Maintaining the Monitor 0 0 4 1 4l General sess em e RR a dee eed 4 1 42 Maintenance Safety Information essene nunne 4 1 4 3 CODIeCUVe S osos op dadedenvas eus dust tested tn ae der psa 4 1 44 CONCEPIS sso ters A ERN ETRAS E 4 1 4 5 Recommendations for Maintenance Frequency s s 4 2 46 Cleaning sese se d ee 9 ye eee EISE D Red 4 3 4 7 Battery Maintenance ssssseeeeee ee 4 4 50 Configuring the Power up Defaults Menu 0000000005 5 1 5 1 General Safety Information lsssleeeeeeeeeeeeee 5 1 52 Power up Defaults Menu sees 5 1 Preface LIFEGARD II Service Manual 60 Testing the Monitor 15s eR Ed OE ERROR Eng d 6 1 6 1 General s 4 i tikan eee ke VER ERR ea 6 1 62 Tes
41. abel A AC Input 3 line connector IEC 320 receptacle 100 240V 50 60 Hz See AC Power on page 4 3 for more information 1A B RS 232 I O DB 9 male gt C Equipotential Equipotential Ground Post The equipotential grounding post may be used xy by facilities as required by their procedures D USB I O USB Host Connector eL LIFEGARD II Service Manual 1 8 Screen Display The LCD displays parameter values real time waveforms alarm messages and screen selection icons Numeric frames Waveform frames Message and Icon frames Waveform Frames Message and Icon Frames C Standard Model Frames Message and Icon Frames Sedation Model 1 9 physiologic parameter tabular trend data 483 107 149 180 CX min 1 4 T c 37 8 a7 Adult 01 06 03 01 09 17 S mmHg 183 107 149 180 V min 85 awRR min Cre ER A 7 xx Adut 01 06 02 01 09 17 Additional Documentation displays icons and numeric values of real time displays real time waveforms graphical trend or displays alarm messages and screen selection icons Numeric Frames Numeric Frames To use the information in this service manual effectively the operation of the monitor and its accessories must be fully understood Refer to the LIFEGARD II Operator s Manual to obtain an understanding of the monitor
42. able to the monitor In this case the battery is either charging or is fully charged Identifying Battery Strength Battery strength can be determined by the color of the battery icon or by the number of illuminated bars on the battery icon The following table describes the battery icon behavior Number of Bars Illuminated Color Used Behavior Status 3 4 0r 5 Green Constant display OK for service 2 Yellow Constant display Finish session Do not begin new session 1 Red Constant display Pull out of service for charging 0 Red Battery icon flashes and Pull out of service Charge immediately message displays f the battery operating time is less than 30 minutes the battery icon flashes A low pri ority audio alarm sounds 1 beep every 4 seconds When the battery is empty a Low Battery INOP message displays in the Message frame and the audible alarm sounds Pressing any front panel button clears the INOP and silences the audible alarm The battery icon continues to flash until the monitor is powered down or automatically switches off and the monitor will sound the loss of monitoring alarm Charging the Battery A complete battery recharge 29096 requires 8 hours in standby mode or 14 hours in operational mode To charge the battery Step Action 1 Connect the monitor to the AC power source using the proper power cord 2 Verify that the AC Input Indicator LED is lit 3 Charge
43. accurate measurements can be caused by incorrect cuff application or use such as placing the cuff too loosely on the patient using the incorrect cuff size or not placing the cuff at the same level as the heart a leak in the cuff or tubing excessive patient motion WARNING The monitor displays results of the last blood pressure measurement until another N measurement is completed If a patient s condition changes during the time inter val between measurements the monitor does not detect the change or indicate an alarm condition WARNING Sometimes electrical signals at the heart do not produce a peripheral pulse If a N patient s beat to beat pulse amplitude varies significantly for example pulsus alternans atrial fibrillation rapid cycling artificial ventilator blood pressure and pulse rate readings can be erratic and an alternate measuring method should be used for confirmation WARNING A patient s vital signs can vary dramatically during administration of agents affect N ing the cardiovascular system such as those used to raise or lower blood pres sure or raise or lower heart rate WARNING As with all automatically inflatable blood pressure devices continual cuff measure ments can cause injury to the patient being monitored Weigh the advantages of frequent measurement and or use of stat mode against the risk of injury 2 7 LIFEGARD II Service Manual 2 8 WARNING In some cases rapi
44. against vertically dripping water Electromagnetic Compatibility Radiated and conducted electromagnetic energy per CISPR Il Class B2 Thermal Operating 5 to 45 C 41 to 113 F Storage 20 to 60 C 4 to 140 F Humidity Operating 5 to 90 RH non condensing Storage 5 to 95 RH non condensing a Devices are suitable for connection to public low voltage distribution systems b For ECG electrodes and ICG sensors storage temperature is 5 to 30 C 41 to 86 F 13 7 Measuring and Displaying Parameters Parameter Specification Heart Rate Range 20 250 b min Heart Rate Accuracy 1 b min per AAMI EC 13 2002 Bandwidth Normal Monitoring 0 5 Hz 40 Hz Bandwidth Extended Low Frequency Range 0 05 Hz 40 Hz user selectable Leads 3 lead user selectable Display Sweep Speeds 12 5 25 and 50 mm s Pacemaker Detection Indicator on waveform display user selectable ECG size sensitivity 0 5 1 2 4 mV cm Lead off Condition detected and displayed Input Impedance gt 5 MO CMRR Common Mode Rejection Ratio gt 90 dB at 50 or 60 Hz Input Dynamic Range 5 mV AC 300 mV DC Defibrillator Discharge lt 5s per IEC 60601 2 27 Recovery bs per AAMI EC 13 2002 13 3 LIFEGARD II Service Manual 13 4 ECG Standards Standards Meets the performance standards of ANSI AAMI EC 13 2002 Instead of a 1 mV standardizing voltage section 4 2 2 9 a fixed 1 cm reference bar is al
45. and its accessories 2 1 2 2 Safety 2 Safety Proper Use This monitor is not intended for neonates ICG mode is intended primarily for adult patients depending on body size Ensure that the monitor is in proper working condition before clinical use If the accuracy of any measurement does not seem reasonable first check the patient s vital signs by alternative means and then with the monitor to make sure it is working properly If you connect the monitor to any instrument verify proper operation before clinical use Refer to that instrument s manual for full instructions Accessory equipment connected to the monitor s data interface must be certified accord ing to IEC 60950 for data processing equipment or IEC 60601 1 for electromedical equipment All combinations of equipment must be in compliance with IEC 60601 1 1 systems requirements Anyone who connects additional equipment to the signal input port or signal output port configures a medical system and is therefore responsible to ensure that the system com plies with the requirements of system standard IEC 60601 1 1 Respiration can only be monitored with an ICU ECG cable set not with an OR ECG cable set This is because of the higher internal impedance of the OR cable set required for use if electro surgery is being performed The care and handling of all accessories should be in accordance with local hospital guidelines policies and procedures NOTE
46. anual Alarm Test Tools Needed e SpO Extension Cable 10 64075 02 Clinical Dynamics Corp SmartSat simulator with Nellcor simulator cable Step Action 1 Return to original factory settings See Restoring Factory Settings page 6 10 2 Connect SpO gt simulator cable to the SpO adapter cable Connect the cable to the SpO patient monitoring input connector 3 Set the simulator as follows Item Setting Oximeter N Oximax SpO 81 BPM 36 Pulse Mod 0 50 4 Press the On Standby button to turn the monitor On 5 After the normal power up sequence verify that the SpO2 display initially indicates zero or is blank 6 Verify that the following monitor reaction occurs a After approximately 45 seconds the monitor displays saturation and heart rate as specified by the tester Verify that the values are within the following tolerances Oxygen Saturation Range 79 to 83 Heart Rate Range 33 to 39 BPM b The audible alarm sounds and both the SpO2 and Heart Rate HR displays flash indicating both parameters have violated the default alarm limits c The HR tone is heard For this test the HR tone source must be set to SpO2 from the Heart Rate Menu 7 Press the Alarm Silence button to temporarily silence the audible alarm 8 Verify the following a The audible alarm remains silenced b The crossed out bell icon displays in each numeric frame on the screen c The SpO296 and HR displays con
47. ating the wheel while in the System A D screen has no effect NIBP Test A NIBP Test screen is provided to facilitate troubleshooting problems and performing verification testing for the NIBP subsystem Typically when these tests are performed the pneumatic system is connected to an external pressure reading device and a closed reference volume The NIBP Test screen provides a real time numeric display of the pressure in the pneumatic system means for controlling the pump and valves are open or closed WARNING A blood pressure cuff connected to the monitor should never be applied to a human being while the monitor is in Diagnostic Mode Injury could result DIAGNOSTIC MENU NIBP TEST Pressure mmHg 0 Proportional Valve Open Safety Valve Open Press NIBP to activate pump release to stop pump Press Volume to open both valves release to close valve Press Alarm Silence to open proportional valve and deflate at 3 mmHg s release to close valve Press Contrast to perform offset adjustment Return 5 7 LIFEGARD II Service Manual The NIBP Test screen elements are described below Menu Item Pressure mmHg Function Displays the real time value of the system pneumatic pressure in mmHg The value is updated at the rate of approximately two times per second Proportional Valve Indicates whether the proportional valve is open or closed Safety Valve Indicates whether the saf
48. ation from EtCO CD Stat Mode Audio Pause Setup Menu ECG VECGIICG Size Bar WY RF Interference A Battery Compartment RS 232 I O Equipotential Grounding Post Attention Consult Accompanying Documents Alternating Current mn Fuse Type Date of Manufacture Y year X Month YYYY XX IPX1 Drip proof m ETL Mark RXony This device restricted to sale by or on the order of a physician Single Patient Use Only Latex free Manufacturing Lot Use by date yyyy mm Use within 7 days of opening package USB Host Connector Safety 2 15 LIFEGARD II Service Manual 2 16 Figure 2 1 Explanation of Symbols continued Symbol Description Shave hair from sites if necessary Wash sites with soap and water Dry sites briskly 3 1 3 2 Site Preparations 3 Site Preparations General This chapter describes site preparation procedures and guidelines to ensure compliance with safety requirements General Site Preparation Safety Information WARNING To avoid contaminating or infecting personnel the service environment or other equipment make sure that equipment which has been used before has been appropriately disinfected and decontaminated WARNING Disconnect the monitor from the AC source by unplugging the power cable from the AC power connector located on the rear of the monitor The On Stan
49. cts in the measurements are suspected Functionality Assurance on page 5 3 Performance Assurance At least once every year or as needed if you suspect defects in the measurements Performance Assurance Test on page 5 7 Replace backlight 20 000 hours about 4 years of continuous use or as needed Replacing the Backlight Tube on page 8 6 NIBP Maintenance Battery Maintenance Every year or as needed if the monitor has been opened or you suspect defects in the measurement Every two years Preventive Maintenance Tests on page 5 9 Battery Maintenance on page 4 4 Maintenance Checklist Topics See Page Inspect Cables Cords and Housing 4 3 Cleaning Guidelines 4 3 Checking the Battery Status 4 5 Charging the Battery 4 5 Testing the Monitor 5 1 NIBP Preventive Maintenance 5 9 Replacing the Backlight Tube 8 6 Assembly Maintaining the Monitor 4 6 Inspecting the Monitor If a problem is discovered while inspecting the LIFEGARD II patient monitor contact your biomedical department or the Life Care Systems Support Group With the monitor in Standby and mains removed Step Action 1 Examine the exterior of the monitor for cleanliness and general physical condition Verify that the housing is not cracked or broken that everything is present that there are no spilled liquids and that there are no signs of ab
50. d prolonged cycling of an oscillometric non invasive blood N pressure monitor cuff has been associated with any or all of the following ischemia purpura or neuropathy Apply the oscillometric cuff appropriately according to the manufacturer s directions for use and check the cuff site and cuffed extremity regularly when blood pressure is measured at frequent intervals or over extended periods of time Check the patient s limb on which the cuff is applied to assure that circulation is not constricted Constriction of circulation is indicated by discoloration of the extremity This check should be performed at the clinician s discretion at regular intervals based on the circumstances of the specific situation Do not place the cuff on an extremity being used for intravenous infusion or any area where circulation is compromised or has the potential to be compromised Do not apply the blood pressure cuff to the same extremity as the one to which an SpO sensor is attached because the cuff inflation disrupts SpOs monitoring and leads to nuisance alarms When in use on patients ensure that heavy objects are not placed on the tubing Avoid crimping or excessive bending twisting or entangling the tubes WARNING i Do not use STAT mode when using the thigh cuff to monitor NIBP Use of this mode causes a loss of monitoring alarm and shuts down all monitor functionality WARNING N Be sure to follow the safety guidelines list
51. dby but ton does not disconnect the monitor from the AC mains supply WARNING Accessory equipment connected to the monitor s data interface must be certified N according to IEC Standard 60950 for data processing equipment or IEC Standard 60601 1 for electromedical equipment All combinations of equipment must be in compliance with IEC Standard 60601 1 1 system requirements WARNING Explosion Hazard Equipment is not suitable for use in the presence of a flamma ble anaesthetic mixture with air or with oxygen or nitrous oxide WARNING i Be sure you have read all applicable instructions before attempting to install the wall mount WARNING Wall mounts that are intended to support monitors must be capable of supporting 4 times the weight of the monitor when properly installed WARNING Do not mount any portion of a monitoring instrument over a patient s bed WARNING Do not exceed the maximum rated load specified for each wall mount WARNING Ensure that no electrical wiring utilities or piping interfere with the selected wall mounting locations 3 1 LIFEGARD II Service Manual 3 3 Site Preparation Guidelines Check that the environment is reasonably free from dust vibration corrosive or explo sive gases and is within specified temperature and humidity ranges See Chapter 13 Specifications Position the monitor so that the display is clearly visible and the controls are easy to r
52. dicated in the the instructions that accompany the accessories and supplies Caution The LIFEGARD II may be used on a patient during defibrillation but the readings may be inaccurate for lt 8 seconds per AAMI EC13 2002 Caution Use standard institutional procedures to dispose of used electrodes Do not re use Caution To avoid obtaining monitored data for a wrong or non existent patient review the entered data for accuracy Caution Whenever the Patient Data Menu is invoked a new patient record is established in the monitor Caution Do not immerse the monitor in liquid or use caustic or abrasive cleaners Caution Do not spray or pour any liquid on the monitor or its accessories N Caution A Safety Anytime you press the Audio Alarm Control button you should check the resulting state of the audio alarms indicated by the icons in the parameter frames to ensure that the alarm system is in the mode you expect Caution gt Whenever you press the Audio Alarm Control button ensure that the alarm sys tem is in the desired mode of operation Caution gt Do not allow any liquid to penetrate connectors or openings in the monitor s chassis Caution gt Caution gt Caution gt Cauti o 3 gt Caution gt After drying a wetted component monitor cable sensor etc obtain the assis tance of qualified service personnel to assure safe op
53. e Care Systems Support Group Please con tact a Service Coordinator at Call 1 978 326 4700 Fax 1 978 977 6854 email Icssupport analogic com You will need to supply the Service Coordinator with the following information The Model number s and Serial number s of the product The quantity of items The Bill to address for invoice purposes The Ship to address A Purchase Order number and Details of the reported failure The Service Coordinator will then inform you of The Return Material Authorization RMA number The warranty or non warranty status of the units being returned Any repair charge 14 1 LIFEGARD II Service Manual All returned material must be shipped PREPAID to the following address Analogic Corporation Life Care Systems 8 Centennial Drive Peabody MA 01960 Attn Receiving Dock B RMA NOTE Please reference your RMA number on both your purchase order and the shipping label 14 2 Analogic Corporation Life Care Systems Division 8 Centennial Drive Peabody MA 01960 7987 USA Tel 978 326 4000 ANALOGICE The World Resource for Health amp Security Technology Printed in the U S A Analogic Corporation 16 00261 01 Rev 00 February 2006
54. e measuring results are accurate See CO Performance on page 6 19 for information on how to perform these tests WARNING A FilterLine connected to the monitor should never be applied to a human being while the monitor is in Diagnostic Mode Injury could result Configuring the Power up Defaults Menu DIAGNOSTIC MENU CO Calibration Pump Op Time Return CO TEST CO Pressure in mmHg ambient cell 745 740 Pump Voltage Volts 3 0 CO mmHg 0 00 Status Set Barometric Pressure mmHg 745 Flow Rate Check and Calibration 07 16 2005 15 13 58 The CO Test Screen is described below Menu Item Function CO Pressure in mmHg ambient cell Displays the real time value of the ambient pressure and the measured cell pressure The ambient pressure value will be the same as the Barometric Pressure value This value CANNOT be changed or reset Pump Voltage Volts Takes the correct amount of air from outside of the monitor This value CANNOT be changed or reset CO mmHg Displays the real time value of COs This value CANNOT be changed or reset Set Barometric Pressure mmHg Select a value which matches the reference value received from a reliable source airport weather station hospital Confirm that the ambient pressure value is the same as the barometric pressure value Flow Rate Check and Calibration Adjust CO flow rate by Decrease Flow or
55. e same electrical potential as the surface of the Earth to avoid the risk of electrical shock if a person touches a device in which an insulation fault has occurred WARNING Disconnect the monitor from the AC source by unplugging the power cable from the AC power connector located on the rear of the monitor The On Standby but ton does not disconnect the monitor from the AC mains supply 3 2 Site Preparations Equipotential Grounding To eliminate potential differences between different pieces of equipment the monitor must have a separate connection to the equipotential grounding system One end of the equipotential grounding cable potential equalization conductor is con nected to the equipotential grounding post on the rear of the monitor and the other end is connected to one point of the equipotential grounding system Combining Equipment All combinations of medical equipment with non medical equipment must comply with IEC 60601 1 1 WARNING Accessory equipment connected to the monitor s data interface must be certified N according to IEC Standard 60950 for data processing equipment or IEC Standard 60601 1 for electromedical equipment All combinations of equipment must be in compliance with IEC Standard 60601 1 1 system requirements 3 6 Monitor Disposal To avoid contaminating or infecting personnel the environment or other equipment make sure you disinfect and decontaminate the monitor appropriately b
56. e simulator displays Leak Test see steps 1 and 2 in the previous table 3 Press the Volume button to ensure that both valves are closed 4 Perform an offset adjustment so that the simulator and monitor both display a pres sure of 0 mmHg or kPa by doing the following a Press the Contrast button on the monitor s front panel b If needed zero the simulator see To Zero the Simulator on Page 6 10 5 Press Start on the simulator 6 Allow 15 20 seconds for the pressure to stabilize The pressure displayed on the monitor and on the simulator should be within 5 mmHg 0 7 kPa of one another Document the difference between the simulator value and the monitor value 7 Press the Stop button on the simulator to stop the test 8 Press and hold the Volume button until the monitor displays a pressure of 0 mmHg or kPa 9 If no further NIBP tests are to be conducted turn the monitor Off Normal monitoring operation returns the next time the monitor is turned On Testing the Monitor Pneumatic Leakage Test This test verifies the integrity of the pneumatic system Step Action 1 Turn the simulator On 2 Perform the following sequence a Press the Home button b Press the Pressure Tests button c Press the Pressure Leak Test button d Press the Setup button e Press 3 0 0 then Enter f Set the Cuff to Internal 3 Confirm that the simulator test screen is
57. each 3 4 Safety Precautions Patient Safety To better ensure patient safety become familiar with the details in Chapter 13 Specifications Patient Leakage Current The patient leakage current is lt 50 A 250V The monitor has patient input connec tors Type CF that are protected against the effects of defibrillation and electrosurgery The following heart symbol is located on the side of the monitor where the patient mon itoring input connectors are The symbol indicates that the monitor is Type CF and is designed to have special protection against electric shocks particularly regarding allow able leakage current having an F Type applied part according to the standards IEC 60601 1 EN60601 1 CSAC22 2 601 1 UL 2601 1 and is defibrillator proof 4 H 3 5 Preparing to Use the Monitor WARNING To avoid contaminating or infecting personnel the service environment or other equipment make sure that equipment which has been used before has been appropriately disinfected and decontaminated Power Source Requirements See the section entitled Electrical in Chapter 13 Specifications for all electrical specifi cations Protecting Against Electrical Shock The LIFEGARD II patient monitor is classified as Class I Equipment with an internal power source in accordance with IEC 60601 1 CSAC22 2 601 1 UL 2601 1 The moni tor has grounding contacts in the power plug ensuring that all exposed conductive sur faces are at th
58. ecifications 13 Specifications This chapter includes all hardware regulatory and measuring specifications for the monitor Hardware Specifications Size excluding handle Width Height Depth Weight excluding accessories options cables Display cold cathode fluorescent backlight Screen Type Active Screen Size Component Specification 13 50 in 34 3 cm 10 25 in 26 0 cm 7 50 in 19 0 cm 12 5 Ib 5 7 kg TFT color 8 3 x 6 2 in 210 8 x 157 5 mm 10 4 in 264 2 mm diagonally Resolution 640 x 480 pixels Recorder Type Thermal Weight 0 9 Ib 41 kg Paper Width 50 mm Speeds 12 5 25 and 50 mm s Safety Standards Parameter Specification United States Federal Law restricts this device to sale by or on the order of a physician CE Marking Medical Device Directive 93 42 EEC EN 60601 1 EN 60601 1 1 EN 60601 2 27 EN 60601 2 30 EN 60601 2 49 UL 60601 1 EN 60601 1 8 CAN CSA C22 2 No 601 1 M90 EN 864 ISO EN 9919 Protection Class Class internally and externally powered equipment per IEC 60601 1 clause 2 2 4 Degree of Protection Type CF IPX1 per IEC 60601 1 clause 2 1 26 Mode of Operation Continuous 13 1 LIFEGARD II Service Manual 13 2 13 4 Audible Alarms Parameter Specification High Priority Alarm Frequency Component Sound Pressure 625 Hz base frequency 1250 Hz 1875 Hz 2
59. ed below Use only Analogic specified sensors for the LIFEGARD II monitor Do not use the thermometer if you see any signs of damage to the probe When performing defibrillation or electrosurgery there is a potential for signal corruption WARNING M The monitor is a respiration rate monitor only Do not use it for Loss of Respiration detection or to monitor neonates WARNING N Respiration monitoring is suspended when in ICG mode WARNING Keep patients under close surveillance when monitoring respiration Respiration N signals are sensitive to interference from radiated electromagnetic signals Although unlikely radiated electromagnetic signals from sources external to the patient and monitor might cause inaccurate respiration readings WARNING N Do not rely entirely on the monitor s respiration readings for patient assessment WARNING T If you permanently silence the respiration rate limits audible alarm the crossed bell is present the Loss of Respiration signal audible alarm is also permanently silenced WARNING i ICG mode is not for use on neonatal or pediatric patients Safety WARNING N The following patient conditions anomalies may limit the accuracy of data aortic valve regurgitation serious hypertension MAP gt 130 mmHg septic shock WARNING N This system is not recommended for recording measurements during open heart surgery WARNING Do not use on patients w
60. efore disposing of it in accordance with your country s law for equipment containing electrical and elec tronic parts For disposal of parts and accessories such as ECG and SpO gt where not otherwise spec ified follow local regulations regarding disposal of hospital waste For disposal of the lead acid battery follow local regulations for safe disposal of lead WARNING N Explosion Hazard Equipment not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide 3 7 Unpacking the Monitor The box comes with the following The LIFEGARD II Operator s Manual The LIFEGARD II patient monitor An AC power cord In addition you should receive all the accessories and options that you ordered If there is anything missing contact your Analogic Corporation representative immediately 3 8 Checking the Shipment Examine the carton carefully for evidence of damage in transit If any damage is discov ered contact the carrier immediately Retain all packing material If the monitor has to be returned contact your Life Care Systems Support Group repre sentative for shipping instructions 3 3 LIFEGARD II Service Manual To pack the monitor for return disconnect all cable Pack the monitor in its original shipping carton If this is unavailable use a suitable carton with appropriate packing material to protect the monitor during shipping NOTE When returning t
61. emoraunnginnelzanon 2 If problem persists replace main PCB module 6E 71 SpO module has detectedan 1 Replace SpO module rror on its serial port B P 2 If problem persists replace main PCB module 7 7 LIFEGARD II Service Manual Error Code Categories As a reference the following table lists the general categories for other error codes The error code categories are shown only in hexadecimal format If unable to solve problem contact Analogic Life Care Systems technical support group Hexadecimal Code Explanation 500xxx internal user interface error 501xxx remove serial port error 502xxx date and time error 503xxx NIBP error 504xxx front end error 505xxx alarm error 506xxx audio error 507xxx recorder error 508xxx trend error 509xxx flash memory data error 50axxx SpO error 50bxxx ECG error 50cxxx power down task error 50dxxx on board diagnostic error 50exxx power monitor error 50fxxx temperature measurement error 510xxx internal user interface error 511xxx error handling error 513xxx serial driver error 514xxx system error 515xxx CO error Other Error Codes If an error code occurs that is not listed in the above sections take the following actions Step Action 1 Power cycle the monitor 2 If the error code still displays take the monitor out of service and contact the Analogic Life Care Systems support group or you
62. en ever the battery is suspected as being the source of the problems All other tests must be performed at least once every year if the monitor has been opened or if you suspect defects in the measurements Safety Checks in accordance with IEC 60601 1 Ground Integrity Electrical Leakage Earth Leakage Current Enclosure Leakage Current Patient Leakage Current Patient Leakage Current with Mains Voltage on the Applied Part At least once every 2 years after any repairs if the monitor has been dropped or opened 6 3 LIFEGARD II Service Manual Test Map The Test Map shows which tests are required in which situations Service Event When performing Test Block Required complete these tests Installation Monitor opened Battery replacement Visual Power On Power On Pneumatic Leakage Test All Safety Tests Power On Battery Performance Speaker replacement Power On Pneumatic Leakage Test All Safety Tests Backlight tube replacement Power On Pneumatic Leakage Test All Safety Tests NIBP pump replacement SpO module replacement Power On Pneumatic Leakage Test All Safety Tests Preventive Maintenance Tests Power On Pneumatic Leakage Test All Safety Tests SpO Test CO module replacement Power On Pneumatic Leakage Test All Safety Tests CO Tests Power supply module r
63. ents WARNING Using an SpO sensor during MR imaging can cause severe burns Minimize this N risk by positioning the cable so that no inductive loops are formed In the sensor does not appear to be operating properly remove it immediately from the patient WARNING Do not use disposable sensors on patients who have a known allergic reaction to N the adhesive WARNING Reusable sensors must be moved to a new site at least every 4 hours Because N individual skin condition affects the ability of the skin to tolerate sensor placement it may be necessary to change the sensor site more frequently with some patients If skin integrity changes move the sensor to another site WARNING T Do not alter or modify the ANAK ACOO1 Nellcor Durasensor Alterations or modifi cations may affect performance or accuracy WARNING As with all medical equipment carefully route cables to reduce the possibility of patient entanglement or strangulation WARNING Carefully apply the sensor to the patient as described in Chapter 8 of the opera N tor s manual The sensor may be connected directly to the Analogic LIFEGARD Is side panel connector identified with the SpO icon Typically however it is more convenient to connect the sensor to the monitor by using an SpO extension cable P N AN4K AC004 Periodically check to see that the sensor remains prop erly positioned on the patient and that skin integrity is acceptable
64. eplacement Power On Pneumatic Leakage Test Safety Tests Patient monitoring I O module replacement Communications module replacement Power On Pneumatic Leakage Test All Safety Tests All Performance Tests Power On Pneumatic Leakage Test Safety Tests Testing the Monitor 6 7 Equipment The following table lists the recommended equipment and accessories required for per formance verification Equipment Description Brass hose connector Swagelok 1 8 NPT to 1 8 male hose barb con nector Digital multimeter DMM Fluke model 87 or equivalent SpO extension cable 10 64075 02 SpO gt reusable sensor adult finger AN4K ACO01 ECG patient cable 10 64667 01 ICU or 10 64667 02 OR ECG electrodes AN4K AC033 ECG lead sets 10 64669 01 AAMI or 10 64669 03 IEC NIBP tubing AN4K AC019 NIBP reusable cuff adult AN4K AC017 Pulse oximeter tester Clinical Dynamics Corp SmartSat simulator with Nellcor simulator cable ECG simulator Dynatech Nevada medSim 300 or equivalent NIBP simulator Bio Tek BP Pump 2 or equivalent Pressure indicator Condec Model DLR334 CABBA or equivalent Temperature simulator MedSim 300 or equivalent Respiration simulator MedSim 300 or equivalent Safety analyzer Bio Tek 601 Pro or equivalent Stopwatch Manual or electronic Screwdriver f
65. er Specification Technique OxiMax Sensors Range Saturation 1 to 100 Pulse Rate 20 to 300 b min Accuracy Sp0 0 69 not specified 70 100 3 digits Pulse Rate 20 to 250 b min 3 b min gt 250 b min not specified Display Update Period 1 second Calibration functional OxiMax Sensors Wavelength 660 nm and 890 nm Energy Not exceeding 15 mW 13 6 C Complies with EN 864 ISO 9918 Specifications Parameter Specification Technique The CO module together with the appro priate FilterLine Range 0 to 98 mmHg 0 to 13 kPa or 18 EtCOs whichever is lower Flow Rate 50 7 5 ml min Warm up Time 180s max typically 30s Gas Sampling Delay Time 2 7s Resolution Numeric 1 0 mmHg 0 1 kPa Wave 0 1 mmHg 0 01 kPa Rise Time 190 ms for adult mode measured with sample line for humidified ventilation and airway adapter for adult Calibration Interval 4 000 operating hours Auto Zero Intervals lt 2 duty cycle Increases if the tempera ture changes by 8 C from the previous Auto Zero interval or the pressure changes by 45 mmHg Leak Tightness Accuracy 40 mbar min with 3096 vacuum 0 20 minutes 0 to 38 mmHg 4 mmHg 38 to 99 mmHg 12 of indicated value gt 20 minutes 0 to 38 mmHg 2 mmHg 38 to 99 mmHg 5 of indicated value 0 08 for every 1 0 mmHg above 40 mmHg a Accuracy applies for respiration rate up to 80 b
66. erating condition To protect the monitor from damage during defibrillation for accurate ECG infor mation and to protect against noise and other interference use only ECG elec trodes and cables specified by Analogic Do not use disposable sensors in a high humidity environment such as in the presence of fluids which may contaminate sensor and electrical connections causing unreliable or intermittent measurements Extension Cables Do not use more than one SpO extension cable 10 64075 02 Electrical Interference Position the sensor cable and connector away from power cables to avoid electrical interference g c zt o 3 gt Do not use the SpO ear transducer for patients with a small ear lobe as incorrect measurements may result Caution gt If you measure SpO on a limb that has an inflated NIBP cuff the arterial blood isn t pulsing anymore and therefore no new SpO value and no pulse rate can be determined during that time To prevent an SpO INOP alarm in those cases the monitor can detect this condition and suppress this alarm but there may be a delay of up to 60 seconds in indicating critical patient status such as sudden pulse loss of hypoxia Caution A Do not wrap the cuff too tightly around the limb It may cause discoloration and ischemia of the extremities 2 11 LIFEGARD II Service Manual 2 12 Caution AN Inspect the application site regularly to ensure skin qual
67. essor Memory and Control section contains the system CPU and all digi tal support circuitry The latter includes the RAM non volatile memory and real time clock This section also contains the display logic keypad switch interface logic RS 232 I O control USB and printer logic Display The display is a TFT color backlit fluorescent LCD unit The active screen size is 8 3 x 6 2 in 210 8 x 157 5 mm 10 4 in 264 2 mm diagonally and the resolution is 640 x 480 pixels Keypad The keypad circuit contains five pushbutton membrane switches and two green LEDs The LEDs are driven by the power supply system and indicate the power source The On Standby button connected directly to the power supply toggles the power between On and Standby modes When in Standby the display is blank and no moni toring is performed However the batteries are charging if an AC source is connected to the rear panel The Audio Alarm Control button is connected directly to the processor and to the sys tem power supply Response of the processor depends upon the action in pressing this button If momentarily pressed less than 2 seconds alarms are paused temporarily for a preset interval determined by the menu selection If pressed twice within 10 seconds the alarm sounding for a specific parameter is silenced temporarily for a preset interval determined by the menu selection Other alarms not related to this parameter can still sound during this
68. ety valve is open or closed Activate Pump Open Both Valves As long as the NIBP button is pressed the pump runs If sys tem pressure reaches the hardware over pressure protection point 280 to 330 mmHg or 37 3 to 44 0 kPa the safety valve opens and the pump disables until the pressure falls below the safety threshold As long as the Volume button is pressed the safety valve and proportional valve opens and remains at maximum Deflate Offset Adjustment As long as the Alarm Silence button is pressed the proportion al valve opens and bleeds off pressure ar the rate of 3 1 5 mmHyg s It is useful to control the bleed rate to 3 mmHg s to facilitate certain AAMI SP10 tests Any time the bleed rate falls below 3 mmHg s the valve opens and remains at maximum as long as the button is pressed Momentarily pressing the Contrast Adjust button invokes the Zero Calibration routine that is performed immediately prior to each blood pressure measurement This routine looks at the pressure in the system and if the pressure is non zero an offset is applied which causes the system pressure to display as Zero When in the NIBP Test screen the Return option is always highlighted Press the wheel to return to the Diagnostic Menu Rotating the wheel while in the NIBP Test screen has no effect CO Test The CO Test Screen is provided to facilitate troubleshooting problems and performing verification testing to ensure th
69. fied in the section titled Recommendations for Testing Frequency on page 6 3 Battery Performance Test The battery performance test should be performed every two years before monitor repairs or whenever the battery is suspected as being a source of the problem Before performing the battery performance test verify that the battery is fully charged see Charging the Battery on page 4 5 NOTE Before beginning this test ensure that the monitor is disconnected from the AC power source and that the battery is fully charged Testing the Monitor Tools Needed e NIBP tubing ANAK ACO019 e Bio Tek BP Pump 2 simulator or equivalent with an internal test volume of 310 ml Step Action 1 Connect the NIBP simulator to the monitor via the NIBP tubing 2 Set the NIBP simulator to a pressure setting of 120 80 mmHg 16 11 kPa and a heart rate of 80 BPM 3 With the monitor Off press the On Standby button When the monitor is turned on the battery icon may initially indicate a higher charge then it actually holds wait 5 minutes or until after an NIBP measurement for an accurate battery reading 4 Use the navigation wheel to select the NIBP Menu and set the Automatic Interval Mode option to 15 minutes Select Return to exit the menu 5 Press the NIBP button on the monitor s front panel to start the first NIBP measurement Subsequent NIBP measurements are taken automatically every 15 minutes 6
70. ft Disassembly Step Action 5 Disconnect the display cable located on your left hand side by pulling the connector towards you Disconnect the backlight keypad and speaker cable located on your right hand side Keypad Cables Backlight Cable Speaker Cable Display Cable 6 Separate the front from the rear case Front Case Disassembly After you have separated the front from the rear case you can replace the following from the front case assembly Keypad Speaker Backlight Tube Display LCD and associated items Caution AN Before you disconnect or remove any module make sure you are wearing EDS protection and you are working in a grounded environment Removing the Keypad on the Front Case Step Action 1 The keypad is attached with an adhesive to the front case To remove it carefully lift up one corner of the keypad with a flathead screwdriver 2 Peel the adhesive away from the front case 8 5 LIFEGARD II Service Manual Replacing the Speaker Step Action 1 Use a Philips 1 screwdriver to remove the 3 screws and flat washer fastening the speaker 2 Pull the speaker up Replacing the Backlight Tube The backlight tube is located within the LCD screen However you do not need to dis assemble the LCD screen display to replace the backlight tube Step Action 1 Insert a small thin flathead screwdriver into
71. hapter 13 for typical battery operating times and conditions and see Removing the Battery on page 8 2 for more information Battery Guidelines To get the most out of the battery observe the following guidelines The shelf life of a fully charged battery is about 6 months After a battery has been activated keep it charged If it is not in use recharge it every 3 to 4 months f the monitor is not in use for long periods of time greater than 3 months remove the battery from the monitor Leaving the battery in a monitor that is not regularly using the battery will shorten the life of the battery e Battery Disposal We recommend replacing the monitor s sealed lead acid battery at 2 year intervals Follow local governing ordinances and recycling plans regarding dis posal or recycling of batteries and other device components Do not dispose of the battery in normal waste containers WARNING ii If the battery shows signs of damage or signs of leakage replace it immediately Do not use a faulty battery in the monitor Maintaining the Monitor Checking the Battery Status When the monitor is connected to the AC mains power supply the battery charges automatically Battery status is indicated severy ways LEDs on the front panel of the monitor Battery gauge on the monitor s main monitoring screen NOP messages The AC LED is only on when the power cord is connected and the AC power is avail
72. he NIBP cuff is not kinked NIBP Time Out NIBP measurement took too long to complete Check cuff placement and retry measurement Recorder Out of Paper New paper needed Replace paper as instructed in the section titled Recorder Paper Replacement in the LIFEGARD II Operator s Manual SpOz No Sensor Monitor cannot detect the SpO2 Check that the SpO patient cable is connected and cable or sensor the sensor is properly attached to the patient SpO Equip SpO hardware is faulty Verify failure and replace SpOs module See Malfunction Removing the SpOs Module on page 8 X SpO Weak Signal SpO measurement is erratic 1 Make sure the SpO sensor is correctly placed 2 If this does not solve the problem make sure the sensor is working SpO Interference The level of ambient light is so high that the transducer cannot measure the pulse or the cable is picking up interference Excessive patient movement is causing irregular pulse pat terns 1 Cover the SpO sensor so that it does not get as much ambient light 2 If this does not solve the problem make sure the sensor cable is not damaged 3 Try to reduce patient movement or to relieve the cable strain on the sensor SpO Sensor Off Monitor does not detect SpO sensor Make sure the SpOz sensor is connected SpO gt High Pulse Amplitude SpOz pulse amplitude too high for equipmen
73. he current measured ambient pressure verify the reference value by getting another reading from a differ ent source If the ambient pressure displayed also differs from the new reference by more than 12 mmHg 1 6 kPa the CO module should be replaced 10 Confirm the barometric pressure setting by clicking on the adjusted value so that it is no longer highlighted 11 Check that the ambient pressure displayed in the CO Pressure line at the top of the Screen is the same as the value that you selected from the list in Step 8 LIFEGARD II Service Manual Leakage Check The Leakage Check consists of two parts e Part 1 Checking the tubing between the pump outlet and the CO module outlet Part 2 Checking the tubing between the pump inlet and the FilterLine inlet NOTE Check the flowmeter s user s guide for details on how to make a correct flow reading CO Inlet LS yn p p BUS EAS CO Outlet cll Figure 6 2 CO Inlet and Outlet Part 1 Step Action 1 Check the ambient and cell pressure shown in the status line on the screen The cell pressure should be approximately 20 mmHg 2 7 kPa lower than the ambient pres sure Connect the flowmeter outlet to the FilterLine inlet using a flexible connecting tube Block the CO module outlet using your fingertip and observe the flowmeter display The value on the flowmeter should decrease to bet
74. he monitor for servicing do not return sensors patient cables NIBP tubing and cuff or the power cord 3 9 Returning System Components If it is necessary to return the monitor for service call Analogic Corporation for ship ping instructions Have all equipment serial numbers available when calling To pack the monitor for return disconnect all cables It is not necessary to return sen sors patient cables NIBP tubing and cuff or power cord Pack the monitor to be returned in its original shipping carton if available If not use a suitable carton with appropriate packing material to protect the monitor during shipping Maintaining the Monitor 4 Maintaining the Monitor 4 1 General This chapter describes how to clean the LIFEGARD II patient monitor and keep it in the best working condition 4 2 Maintenance Safety Information WARNING N Follow local governing ordinances and recycling plans regarding disposal or recy cling batteries and other device components WARNING If the battery shows signs of damage or signs of leakage replace it immediately Do not use a faulty battery in the monitor Caution aS Do not immerse the monitor in liquid or use caustic or abrasive cleaners Caution Do not spray or pour any liquid on the monitor or its accessories Caution Do not allow any liquid to penetrate connectors or openings in the monitor s chassis 4 3 Objectives In order to meet this chapter s
75. his button enables the wheel to vary the tone volume 12 10 Navigation Wheel This is a rotating push switch wheel The associated wheel circuitry generates a pulse when pressed and generates a digitally encoded pair of quadrature signals whose relative magnitudes and polarities represent the angular position of the wheel These outputs are connected to the processor where they are interpreted as required for the functions involved Successive angular positions determine the direction of wheel rotation In addition to the functions performed when in conjunction with the keypad as described above the wheel operates in conjunction with the display to select menus and lists of parameter variables 12 11 RS 232 I O This is a rear panel 9 pin connector providing interfaces with other computer systems or equipment The driver for this port is a Universal Asynchronous Receive Transmit UART integrated circuit that interfaces this port with the microprocessor The baud rate for this serial transmission function is programmable from 1200 baud to 38 4 kilobaud Pin number 9 of the RS 232 connector is reserved for a Nurse Call signal The nurse call signal reacts when a low medium or high level alarm is activated 12 12 Speaker The speaker is capable of providing 73 dBA of volume at a distance of one meter during alarm conditions The processor drives the speaker in different patterns as specified for the different alarm priorities and co
76. his message also appears after the Pump Op Time is reset Check the FilterLine and exhaust tube then discon nect and reconnect the FilterLine If the message is still displayed use a new FilterLine If Pump Op Time has been reset perform a flow check and store the flow in Service Mode select Store Flow CO Overrange The CO value is outside the measurement range Refer to Operator s Manual Section 18 CO Purging The monitor is purging the FilterLine This occurs when an occlusion is detected in the line or airway adapter If the occlu sion is not removed by purging a CO2 Occlusion message displays Check for an occlusion and remove If necessary replace the FilterLine CO Auto Zero An AutoZero is in progress An AutoZero will be done at the following intervals 5 minutes after connecting the FilterLine 1 hour later 12 hours later and every 12 hours from there on None needed ECG Leads Off Not all leads are connected Check the integrity of electrodes to ensure they are firmly attached Make sure the ECG trunk cable is connected the leads are connected to the electrodes and the electrodes are attached If the message still displays use a new lead set ICG Artifact Excessive patient movement Restrict patient movement and keep patient calm Confirm that sensors are securely attached check lead wires ICG Leads Off One or more of
77. ing is accomplished on 50 mm wide thermal paper at recorder speeds programma ble up to 55 mm s 12 15 ECG Processing The technique used in ECG senses the varying potential difference between two points at the skin surface which respond to the electro chemical actions of the muscular activi ty of the heart Three electrodes are attached to the patient s right arm RA left arm LA and left leg LL The varying potentials at these locations are cable connected to the ECG circuit inputs where they are conditioned and the difference of potential between two selected leads is digitized before transmitting through opto isolators to the processor The proces sor installed algorithms operate on the signals to develop drivers for the graphic display and to compute the heart rate in beats per minute BPM In addition to the acquisition of the QRS waveform complex the ECG input and subse quent signal processing computing circuitry perform a number of other functions e They detect a lead off condition if one of the electrode connections is disrupted They detect the presence of pacemaker signals within the QRS waveform complex of the ECG 12 16 ICG Processing ICG is a non invasive means of obtaining and evaluating hemodynamic data by measur ing cardiac flow rather than pressure ICG uses impedance cardiography with four sensors Each sensor has two electrodes The sensors are placed on specific areas on the neck and thorax to mea
78. is test is compliant with EN60601 1 Enclosure Leakage Current Test at 110 of the nominal line voltage Step Action 1 Connect the AC mains power cord to the analyzer as recommended by the analyzer operating instructions Using the appropriate test cable connect the analyzer to either of the screws on the back of the monitor next to the handle Turn the monitor on Perform the test as recommended by the analyzer operating instructions The analyzer leakage current indication must not exceed the values listed below Table 6 5 Enclosure Leakage Current EN60601 1 1990 A1 A2 A11 A12 A13 and UL2601 2nd Ed 1997 US Deviations Test Condition Polarity Allowable Leakage Current Normal Normal 100 pA Reversed 100 pA S F C Open Normal 300 JA Protective Earth Reversed 300 JA Patient Leakage Current This test measures patient leakage current in accordance with EN60601 1 Clause 19 for Class I type CF equipment Patient leakage current in this test is measured from any individual patient connection to earth power ground This test requires a sample patient cable for each device parameter These must be con figured as recommended by the safety analyzer operating instructions 6 26 Testing the Monitor Step Action 1 Configure the electrical safety analyzer as recommended by the analyzer operating instructions 2 Connect the moni
79. ith minute ventilation rate adaptive pacemakers The N injected current may cause this type of pacemaker to malfunction and set the pacemaker rate too high WARNING Interference from instruments near the patient and Electro Surgical Unit interfer ence can cause problems with the ICG wave WARNING When using Electro Surgical equipment never place the ICG sensors near the grounding plate of the ES device as this can cause a lot of interference on the ICG signal WARNING Cables and sensors Do not use ICG cables or sensors if damaged Do not sterilize ICG cables by irradiation steam or ethylene oxide Refer to Cable Care Instructions on page 13 18 of the operator s manual Do not immerse ICG cables or sensors completely in water solvents or cleaning solutions WARNING For pacemaker patients the monitor may continue to count pacemaker pulses during cardiac arrest or some arrhythmias Do NOT rely entirely upon the moni tor s alarms Keep pacemaker patients under close surveillance WARNING T Ensure that conductive portions of the cable and electrodes do not come into con tact with any other conductive parts WARNING Use only Analogic supplied ICG cables with the LIFEGARD II Other ICG cables N may cause improper performance and or provide inadequate protection during defibrillation WARNING The continuous display of the B C and X marks on the ICG waveform enable you N to ensure
80. ity and inspect the extremi ty of the cuffed limb for normal color warmth and sensitivity If the skin quality changes or if the extremity circulation is being affected move the cuff to another site or stop the blood pressure measurements immediately Check more frequent ly when making automatic or STAT measurements Caution N A less severe NIBP artifact measurement may produce an NIBP measurement The NIBP Artifact message displays and a low priority alarm tone sounds but pressing the Audio alarm Control button clears the message and alarm tone Caution A If the values appear questionable it is the clinician s responsibility to repeat the measurements Caution N Caution A Trend records are not erased from the monitor s memory when you power off Be aware that when you power cycle the monitor existing trend records will not appear in the display unless the Previous Trend Records option has been set to Make Available To change this display option contact your biomed or other qual ified service personnel When EtCO is off and an ICG cable is connected EtCO will not be available until power ON Standby is cycled Caution A Use only Analogic supplied paper Using incorrect paper can result in damage to your recorder Figure 2 1 Explanation of Symbols Symbol Description REF Reference Number Serial Number CE MDD Marking
81. ivers flathead screwdriver needle nose pliers e 5 8 socket wrench for navigation wheel e 3 16 and 5 16 nut drivers 3 16 socket wrench NOTE During the disassembly procedure some of the small parts may become lost and one the Encoder bushing Adhesive Ring is a single use part and will be destroyed It is strongly advised to purchase and have on hand the Small Parts Kit part number 10 64659 01 see page 9 1 before starting the reassembly process 8 1 LIFEGARD II Service Manual 8 2 8 3 8 4 Disassembly Safety Information WARNING AN Performance Verification Do not place the monitor into operation after repair or maintenance has been performed until all recommended Performance and Safety Tests listed in Chapter 5 Testing the Monitor of this Service Manual have been performed Failure to perform all tests could result in erroneous monitor readings Before attempting to open or disassemble the monitor disconnect the power sup ply from the monitor Before beginning any disassembly procedure the battery must be removed High voltage is generated by the LCD backlight driver Exercise caution when operating the monitor with the covers open Caution AN Observe ESD electrostatic discharge precautions when working within the unit Before removing any module be sure you are wearing ESD protection and you are working in a grounded environment If the internal battery cable has been di
82. lathead and philips Tweezers any model Electronic flowmeter Sierra Instruments 1 Cal 1 gas 5 CO CO Filter Line included Scott Medical Products Note 1 The electronic flowmeter can be purchased from Sierra Instruments www sierrainstruments com products Model 822 13 OV1 PV1 V1 CO GAS 0 75 ml range plus the Power Supply Model 7820 T5 115 VAC input or Model 820 T6 230 VAC input Note 2 The calibration gas 5 CO can be purchased from Scott Medical Products Wwww scottmedicalgases com part number 0304653ORFBD This part number is a kit especially prepared for the Oridion EtCO module It includes a 10 liter canister of 596 CO medical grade calibrated gas and all the required tubing and patient connector 6 5 LIFEGARD II Service Manual 6 8 Serial Numbers When recording test results these are always associated with a particular monitor by means of the serial number The serial number is 10 characters and is located on the back of the monitor e E i amp amp Serial ANALOGIC Bi Number LIFEGARD II DRIVE Xo Re A i Figure 6 1 Serial Number Location 6 9 Visual Test Inspect the system for obvious signs of damage Also check the external leads and accessories 6 10 Passwords Some of the tests may require that you enter the Power Up Default Menu located in the Setup Menu To access Power Up Default Me
83. liquid or use caustic or abrasive cleaners Caution Do not spray or pour any liquid on the monitor or its accessories Caution N Do not allow any liquid to penetrate connectors or openings in the monitor s chassis To clean the monitor dampen a cloth with a commercial nonabrasive cleaner and wipe the top bottom and front surfaces lightly For cables sensors and cuffs follow the cleaning instructions in the Directions for Use shipped with those components If liquid is spilled on the monitor remove the monitor from mains clean and dry it thor oughly before use If in doubt about monitor safety refer the unit to qualified service personnel LIFEGARD II Service Manual 4 4 Battery Maintenance This section provides information on how to handle and maintain the battery WARNING N Follow local governing ordinances and recycling plans regarding disposal or recy cling batteries and other device components About the Battery Storing the monitor for a long period of time without charging the battery can degrade the battery capacity A complete battery recharge 290906 requires 8 hours in standby mode or 14 hours in operational mode If the battery needs charging connect the moni tor to the AC outlet as described in Charging the Battery on page 4 5 If the monitor then operates for less than one hour on battery power before the low bat tery alarm occurs the battery should be replaced See Electrical in C
84. ll external and internal tubing connections No simulator is required for this test and results do not need to be reported Step Action 1 Attach the NIBP cuff to the NIBP tubing and the tubing to the NIBP patient monitor ing input connector 2 Wrap the cuff around itself and place it on a table for the test DO NOT place the cuff on your arm 3 Turn the monitor On and enter the NIBP test screen located within Diagnostic Mode 4 Press the Volume button to close valves 5 a Press and hold the NIBP Start Stop switch until the monitor s screen reads 250 mmHg or 33 3 kPa b Wait 15 20 seconds to allow the pressure to stabilize 6 a Note the value on the screen P1 then start a timer b After one minute note the value on the screen P2 c Calculate the difference between the two values P1 P2 The value should be less than or equal to 6 mmHg 0 8 kPa 7 Press and hold the Volume button until the screen shows the pressure has released and the value is 0 mmHg or kPa 8 Turn the monitor Off NOTE If the test fails ensure the integrity of the cuff and tubing then test again If the test fails again verify the integrity of all the pneumatic tubing inside the monitor Performance Procedures The following accuracy and performance procedures are designed to be completed to verify the accuracy and performance of the monitor They must be performed according to the frequency speci
85. llable Heart Rate 50 100 0 250 25 125 b min NIBP 50 100 0 150 0 300 mmHg SpO 0 100 60 100 80 100 EtCO 0 100 0 60 20 50 mmHg Respiration Rate Temperature C Temperature F Tabular format 0 20 0 50 0 150 b min 15 45 33 41 35 39 C 55 115 91 107 96 102 F One table for all variables Six fields per row time and five vital signs Display interval Per NIBP interval or every 20 minutes when not measuring NIBP Technical Services and Support 14 Technical Services and Support 14 1 General Appendix E includes instructions for obtaining technical assistance and for returning the LIFEGARD II monitor for repairs 14 2 Obtaining Technical Assistance The Life Care Systems Support Group is the resource for providing installation preven tative and corrective maintenance technical and operator support and parts and docu mentation provisioning for Analogic supplied products To Contact the Life Care Systems Support Group Call 1 978 326 4000 MA and International Spare Parts 1 978 326 4700 MA and International Repair 1 978 326 4700 MA and International Technical Assistance 1 978 326 4170 MA and International 800 977 6929 U S Fax 1 978 977 6854 MA and International email Icssupport analogic com 14 3 Return Material Procedure To return a defective product to Analogic you will need to obtain a Return Material Authorization RMA number from our Lif
86. m the user when the monitor has been unable to perform an operation 7 1 LIFEGARD II Service Manual 7 2 7 4 Part 1 Troubleshooting Checklist If any unit is not functioning properly your first step is to restore factory settings See Restoring Factory Settings on page 6 10 for additional information Checks for Obvious Problems When first troubleshooting the monitor check for obvious problems by answering the following questions 1 Is the monitor turned On 2 Is the battery adequately charged 3 If running from mains power supply is the AC power cord connected to the monitor and plugged into an AC outlet Checks Before Opening the Monitor You can isolate many problems by observing indicators on the monitor before it is nec essary to open the monitor Front Panel LED Description AC LED ru On mains connected battery charging Off mains unplugged Battery LED On DC power on monitor on Off DC power off monitor off The following two steps are to make sure that the monitor s AC power supply and bat tery work correctly What to do if the monitor cannot be switched on AC powered Step Action 1 Ensure the battery has had ample time to charge at least 15 minutes A dead bat tery will prevent the monitor from powering On 2 Check AC fuses in the AC receptacle 3 The monitor should either be returned to the factory see Section 14 or opened to isolate the defective component
87. n and set the pacemaker rate too high WARNING When using Electro Surgical equipment never place ECG electrodes near to the N grounding plate of the ES device as this can cause a lot of interference on the ECG signal WARNING A Use only Analogic recommended SpO sensors for SpOs measurements Other SpO sensors may cause improper performance i Safety WARNING Tissue damage can be caused by incorrect application or use of an SpO sensor N For example by wrapping the sensor too tightly or by applying supplemental tape Inspect the sensor site as directed in the sensor directions for use to ensure skin integrity and correct positioning and adhesion of the sensor WARNING Do not use damaged SpO sensors Do not use an SpO sensor with exposed optical components Do not immerse sensor completely in water solvents or cleaning solutions because the sensor and connectors are not waterproof Do not sterilize SpOs sensors by irradiation steam or ethylene oxide Refer to the clean ing instructions in the directions for use for reusable SpO sensors WARNING Inaccurate readings could result if a sensor is used incorrectly Before using a sen sor carefully read and understand the sensor directions for use WARNING Although some sensors are also specified for use on very small patients N neonates as well as infant pediatric and adult patients the monitor is not intend ed for use on neonatal pati
88. n of performance Protect the N monitor from sources of intense electromagnetic radiation This device has been designed to provide resistance to electromagnetic interference However because of the proliferation of radio frequency transmitting equipment and other sources of electrical noise in the healthcare and home environments such as cellular phones mobile two way radios electrical appliances it is possible that high levels A of such interference due to close proximity or strength of a source may result in disruption of performances of this device Disruption may be evidenced by erratic readings cessation of operation or other incorrect functioning If this occurs the site of use should be surveyed to determine the source of this disruption and actions should be taken to eliminate the source If assistance is required contact the Life Care Systems Support Group WARNING All IEC EN 60950 equipment including printers must be positioned no closer than 1 5 meters to the patient s bed WARNING N The monitor is not intended for use on more than one patient at a time WARNING Use only the supplied power cord If in doubt about the integrity of the grounding of the AC power source operate the monitor only from its battery WARNING N Use only the approved accessories for the LIFEGARD II patient monitor WARNING N Do not connect this monitor to any other equipment or device other than those specified i
89. n the monitor s front panel 3 Still pressing the Volume and Contrast buttons press the On Standby button to turn the monitor On 4 Continue to press the Volume and Contrast buttons until the power up diagnostic sequence is complete When the main monitoring screen displays release the two buttons 5 Select your language from the following screen then select Yes to place the monitor into that language After language is selected the main monitoring screen displays English Dutch Chinese Turkish French Norwegian German Swedish Italian Finnish Japanese Polish Portuguese Czech Spanish Danish Russian Greek English Yes Demo Mode The simulation of patient data in the Demo Mode is to verify functionality of the vari ous circuits without the use of sensors or a patient It is also used as a convenient train ing tool While in Demo Mode the message DEMO is displayed in the Message frame To exit Demo Mode power cycle the monitor from Power On to Standby and back to Power On WARNING While in Demo Mode real patient monitoring ceases operation All displayed patient data is simulated NOTE Demo mode is not 10096 conclusive proof that the monitor is functioning Although much of the internal circuitry is tested the patient input circuits are not 6 1 6 2 6 3 Testing the Monitor 6 Testing the Monitor General This chapter provides a checklist of testing procedures used to
90. n this Operator s Manual WARNING A If the battery is defective the loss of monitoring alarm may fail to sound Neither the Print On Alarm nor the Nurse Call signal initiates when the monitor detects a loss of monitoring state If an alarm condition except those leading to a loss of monitoring alarm occurs while the monitor is in the Audio Off state the only alarm indication are visual dis plays related to the alarm conditions WARNING Use only Analogic ECG leads with the LIFEGARD II monitor Other ECG cables N and leads can cause improper performance and or provide inadequate protection during defibrillation WARNING N Do not use damaged ECG leads WARNING j Do not immerse ECG leads completely in water solvents or cleaning solutions because the connectors are not waterproof 2 3 LIFEGARD II Service Manual 2 4 WARNING When you are connecting the electrodes or the patient cable make sure that the N connectors never come into contact with other conductive parts or with earth In particular ensure that all of the ECG electrodes are attached to the patient to pre vent them from contacting conductive parts or earth WARNING Sterilization is not recommended for this monitor related products accessories or supplies unless otherwise indicated in the Instructions for Use that accompany the accessories and supplies WARNING Respiration can only be monitored with an ICU ECG cable set not wi
91. nd Support 00 eee eee eee 14 1 TAY General se sects cheat tees anna ee ts Roatan ares SS 14 1 14 2 Obtaining Technical Assistance 0 cece eee eee 14 1 14 3 Return Material Procedure 0 0 cee eee eee 14 1 Preface 1 1 1 2 1 3 Introduction 1 Introduction General Safety Information WARNING l This monitor is not intended for neonates WARNING i B If you connect the monitor to any instrument verify proper operation before clinical use Refer to that instrument s operator s manual for full instructions WARNING Accessory equipment connected to the monitor s data interface must be certified l according to IEC Standard 60950 for data processing equipment or IEC Standard 60601 1 for electromedical equipment All combinations of equipment must be in compliance with IEC Standard 60601 1 1 systems requirements WARNING i Anyone who connects additional equipment to the signal input port or signal output H port configures a medical system and is therefore responsible to ensure that the system complies with the requirements of system standard IEC Standard 60601 1 1 If in doubt contact the Life Care Systems Support Group see page 14 1 NOTE The monitor and its accessories must be tested by qualified service personnel at regular intervals to verify proper operation according to the procedures of the user s institution Other important safety information i
92. nditions Refer to the LIFEGARD II Operator s Manual for descriptions of alarm responses 12 13 USB Printer Interface The AN4300 acts as a USB host supporting USB Rev 1 1 Only USB printers are sup ported by the USB port 12 4 Theory of Operation and System Architecture 12 14 Recorder The optional recorder module is installed in the right panel of the monitor Refer to the LIFEGARD II Operator s Manual for printing procedures It provides users with the capability to obtain hardcopy records of selected vital sign information Basic control of the recorder is implemented by two pushbutton controls on the recorder s front panel The Continuous button is used to obtain continuous recordings of the real time waveforms displayed in the top two graphic frames Along with the wave forms the recorder prints the values of the vital signs being displayed The printing con tinues until the user presses either recorder button a second time The Snapshot button initiates a snapshot printout for 20 seconds of the same information recorded by the continuous control If scrolling is enabled in a display frame containing trend data when the Continuous but ton is operated then the trend record for that vital sign is printed If the Snapshot button is operated then only the trend data on the display is printed The recorder may be programmed via the monitor menu display to print a snapshot recording when an alarm condition occurs Print
93. nect the ECG leads to the appropriate jacks on the ECG simulator Connect the ECG leads to the ECG trunk cable Connect the cable to the ECG patient monitoring input connector Set the simulator for a respiration rate of 120 breaths per minute Press the On Standby button to turn the monitor On oO a AJ OJN After the power up sequence verify the following monitor reactions a The monitor displays a respiration rate of 120 3 breaths per minute b The audible alarm sounds and the Respiration Rate frame flashes indicating the respiration rate is above the default upper alarm limit 7 Press the Alarm Silence button to silence the alarm 8 Decrease the respiration rate setting on the respiration simulator to 20 breaths per minute Verify that the monitor displays a respiration rate of 20 3 breaths per minute SpO Performance SpO testing includes the following tests Dynamic Operating Range LED Excitation Test Tools Needed for SpO Tests Clinical Dynamics Corp SmartSat simulator with Nellcor simulator cable e SpO Extension Cable 10 64075 02 e SpO reusable sensor adult finger AN4K ACO001 LED Excitation Test This procedure uses normal system components to test circuit operation A SpO adult finger reusable sensor is used to examine LED intensity control The red LED is used to verify intensity modulation caused by the LED intensity control circuit Step Action
94. ng the Main PCB Module on page 8 8 Recorder is not printing Defective recorder Check that paper is installed properly and it is correct type Analogic P N ANAK ACO60 Check that the recorder is correctly installed If prob lem still exists replace recorder according to the instructions in Removing the Optional External Recorder on page 8 4 LIFEGARD II Service Manual Isolating the Defective Component continued Symptom Cause of Failure Remedy Recorder paper will not advance Paper is loaded incorrectly Defective recorder Replace paper as instructed in the section titled Recorder Paper Replacement in the LIFEGARD II Operator s Manual Check that the recorder is correctly installed and there is paper in the recorder If problem still exists replace recorder according to the instructions in Removing the Optional Recorder on page 8 4 No sound from monitor Tone is switched off or low 1 Turn the volume up by pressing the Volume button 2 Power cycle monitor Tone should sound when monitor boots up 3 Check cable connections to the speaker Incorrect Time Stamps Invalid data stored showing wrong times for data The monitor s real time clock is defective Real time clock not set correctly Power the monitor On and then reset the time and date See the LIFEGARD II Operator s Manual for instructions on how to set the date and time Ca
95. nnot reprogram the time and date correctly Main PCB module malfunction Replace the Main PCB module according to the instructions in Removing the Main PCB Module on page 8 8 No tone alarms Speaker will not work Audible alarms are not switched on Cable disconnected Defective speaker Make sure audible alarms are switched on Reconnect cable Replace speaker The knob is rotated no highlight appears on the display screen and or the monitor does not respond to wheel presses Main PCB module malfunction Replace the Main PCB module according to the instructions in Removing the Main PCB Module on page 8 8 7 6 Troubleshooting 7 6 Part 3 Using Support Functions When the monitor detects an error condition the monitor shows an error code on the display screen If such an error occurs during monitoring operation an audible alarm tone also sounds Press the Alarm Silence button to terminate the audible alarm tone When an error code appears on the display a number in hexadecimal representation indicates the nature of the error Additionally Diagnostic Mode can be used to gain access to an error code record stored in non volatile memory of the last 10 error codes encountered See Diagnostic Mode in Chapter 6 for further details Each error code corresponds to a particular problem in the monitor Recommended actions to take when an error code is encountered are listed below Ser
96. nt Auto Set Limits from being invoked If so select Deny Access Audio Pause Period 30 60 90 120 default 180s Time is indicated in seconds Pressing the front panel Alarm Silence button temporarily silences audible alarms for the time indicated Enter Diagnostic Mode Yes No If Yes is chosen the Power up Defaults Menu is exited and the Diagnostic Menu displays For more information see Diagnostic Mode on page 5 4 Language 8 English French German Italian Japanese Portuguese Spanish Russian Chinese Dutch Turkish Arabic Norwegian Swedish Finnish Polish Czech Danish or Greek All text shown on the screen is in the selected lan guage The selected language is effective the next time the monitor is powered up Enter Demo Mode Patient Data Units Yes No U S Metric default If Yes is chosen the monitor simulates patient inputs For more information see Demo Mode on page 5 10 This selection controls the engineering units for patient weight and height used in ICG mode AN4321P and AN4323P Previous Trend Data Make Available Deny Access default If Make Available is chosen all stored trend data from all records can be viewed The default allows only the current patient record to be viewed Low Priority Alarm Interval 4s default 15s This defines the repetitive interval of the two beeps Return When selected the Power up Defaults
97. nu you must enter a password The pass word is 2 1 5 6 6 Testing the Monitor 6 11 Functionality Assurance Tests The following assurance checks are recommended to verify proper operation daily before the monitor is used to monitor a patient During functionality assurance checks verify the overall operation by completing the following Performance Assurance Tests Performance Assurance Test To verify the monitor works properly perform the following test Step Action 1 Using the supplied AC power cord connect the monitor to the AC power source 2 Verify that the AC LED is lit 3 Do not connect any patient monitoring input connectors or cables to the monitor If there are any such connections disconnect them If the monitor is in Standby press the On Standby button The monitor must perform the following sequence a The screen backlight illuminates b Three consecutively higher pitched chimes sound while the version numbers of the boot and operational software display c After successful completion the main monitoring screen displays No vital sign numeric values or waveforms display If an error codes display or the screen remains blank refer to Chapter 7 Troubleshooting Power On Self Test After you first press the On Standby button the monitor displays a startup screen and conducts a set of self diagnostic test routines 6 7 LIFEGARD II Service M
98. nual Domestic Issued Patents and Applications for Patent Marking for Oridion Microstream Technology US Patent Number Title 4 755 675 5 300 859 5 657 750 5 857 461 6 428 483 6 422 240 6 437 316 zb Sene oe oe Se Gas Analyzer amp A Source of IR Radiation Therefor IR Radiation Source amp Method for Producing Same Fluid Filtering Device Utilizable with Gas Monitors Multiple Channel Sample Port Waveform Interpreter for Respiratory Analysis Oral Nasal Cannula Fluid Analyzer with Tube Connector Verifier This product is covered by one or more of the following U S A patents and their foreign equivalents 4 755 675 5 300 859 5 657 750 5 857 461 6 428 483 6 422 240 and 6 437 316 Additional patents pending Japanese patent 1 980 816 PROPRIETARY MATERIAL Information and descriptions contained in this manual are the property of Analogic Corporation and may not be copied reproduced disseminated or distributed without express written permission from Analogic Corporation Information furnished by Analogic Corporation is believed to be accurate and reliable however no responsibility is assumed by Analogic for its use or any infringements of patents or other rights of third parties that may result from its use No license is granted by implication or otherwise under any patent or patent rights of Analogic NOTE The information contained in this manual is valid only for the operating version s printed in the inside front
99. on 1 Remove the connector from the NIBP pump Connector Cut the tie wrap Tie Wrap Removing the Power Supply Module Step Action 1 Use the needle nose pliers to unplug the three connectors Battery Cables Power Supply Board Connector 1 Connectors 2 amp 3 Communications Module Remove the two screws that connect the power supply to the rear panel Remove the screws on the side and bottom of the rear panel Cut the tie wrap that holds the battery cables together OJo BR wy My Use a 5 16 nut driver to unfasten the power supply from the rear panel Pull the power supply module away from the rear panel 8 11 Spare Parts 9 Spare Parts Spare parts are listed in the tables that follow 9 1 Small Parts Kit Most small parts and hardware can be found in the Small Parts Kit Part Number 10 64659 01 The table below call out the contents Quantity Description 1 Gasket EMI RFI double sided contact strip 1 Ground strap RFI 3 x 0 5 7 62 mm x 1 27 mm 1 Encoder bushing locking ring 1 Cable tie Machine screw PHCR 4 40 x 1 4 SS Machine screw PHCR 6 32 x 1 4 SS 10 Machine screw PHCR 6 32 x 3 8 SS Machine screw PHCR 6 32 x 1 2 SS Machine screw PHCR 6 32 x 1 SS Machine screw MAX 16 DIN7985 SS Washer FL NO 4 SS M Washer M4 DIN6798A SS Nut KEPS 6 32 SS N w a 2o N amp
100. ood enters the vascular bed and both blood volume and light absorption increase During diastole blood vol ume and light absorption reach their lowest point The measurement is based upon the difference between maximum and minimum absorption focusing on the pulsatile arteri al blood 12 20 CO Processing The Microstream CO board consists of an micro Controller with memory the Flow system FilterLine recognition system Inlet solenoid valve Measurement Cell Exciter IR Source Detectors and Temp Sensor and an analog section with ADC 12 6 Theory of Operation and System Architecture The gas inlet allows the connection of Microstream FilterLines The FilterLines are detected by the Optical Code Recognition 12 21 Temperature Processing Measurement of patient temperature is accomplished by processing the signal from a probe containing a resistor whose impedance is temperature dependent The class of such components is called thermistor The LIFEGARD II is designed to accept the signals from Series 400 probes manufac tured by Yellow Springs Incorporated Interchangeable probes in this series may be used for esophageal rectal skin or surface or airway temperature measurement Probes are furnished with a standard 10 feet lead Extension leads are available The signal from the probe is conditioned by the monitor s input circuitry processed and used to drive the numeric display 12 7 13 1 13 2 13 3 General Sp
101. ow cannot be adjusted to within tolerance the pump should be replaced If the flow adjustment still cannot be made this indicates a fault in the CO module which must be replaced 6 21 LIFEGARD II Service Manual CO Gas Measurement Calibration Check With the monitor on wait at least 20 minutes before checking the calibration The filter line must be attached Step Action 1 Check that the 5 calibration gas is connected See Figure 6 3 2 Calculate the expected measurement value in mmHg as follows 0 05 x ambient pressure 1 03 value mmHg i e 0 05 x 736 mmHg 1 03 35 7 mmHg with an ambient pressure of 736 mmHg Note Dividing by 1 03 compensates for the dry calibration gas at room temperature relative to breath gases containing water vapor and at body temperature Highlight and depress CO Calibration Wait for the status message CO module reset in progress to disappear Depress the button on the canister to allow 5 CO gas to flow into the monitor Allow the displayed CO value third row of CO Test menu to stabilize Check that the CO value on the monitor matches the calculated mmHg value 2 6 mmHg If the value is outside the tolerance calibrate as described in Steps 5 through 9 If not already connected connect the 5 calibration gas Highlight and depress CO Calibration to enter the Calibration sub menu Wait for the status message CO module reset in progress
102. owing sequence a Press the Home button b Press the Pressure Tests button c Press the Pressure Relief button d Press the Setup button e Press 3 3 5 then Enter Confirm that the simulator is active and displays Relief Valve Test Press the Volume button to ensure that both valves are closed Perform an offset adjustment so that the simulator and monitor both display a pres sure of 0 mmHg or kPa by doing the following a Press the Contrast button on the monitor s front panel b If needed zero the simulator see To Zero the Simulator on page 6 10 Press the Start button on the simulator The peak value X4 shown on the simula tor should be between 270 mmHg and 330 mmHg 35 9 kPa and 43 9 kPa The pressure should return to 0 automatically on the monitor and simulator Both condi tions should be true for the monitor to pass this test If no further NIBP tests are to be conducted turn the monitor Off Normal monitoring operation returns the next time the monitor is turned On Testing the Monitor Deflation Rate Test This test verifies the deflation rate of the monitor Step Action 1 Turn the simulator On 2 Perform the following sequence a Press the Home button b Press the Pressure Tests button c Press the Pressure Leak Test button d Set the Cuff to Internal 3 Confirm that the simulator is active and displays Leak Test 4 Press the
103. patient monitoring input connector 3 Set the temperature simulator as follows a Temperature 37 C 98 6 F b Probe Type YSI 400 Series 4 Press the On Standby button to turn the monitor On 5 After the power up sequence verify the temperature reads 37 C 0 1 C 98 6 F 0 2 F if Fahrenheit is selected as the temperature unit 6 Turn the monitor to Standby 6 15 LIFEGARD II Service Manual ECG Respiration Performance This section includes tests for both ECG and Respiration Tools Needed for both ECG and Respiration Testing e ECG lead sets 10 64669 01 AAMI or 10 64669 03 IEC ECG patient cables 10 64667 01 ICU ECG Test The accuracy of the monitor s ECG measurements is 5 BPM In the following proce dure add the tolerance of the simulator to the acceptable range of readings Step Action 1 Verify that the monitor is in Standby Connect the ECG leads to the appropriate jacks on the ECG simulator 2 Connect the leads to the ECG trunk cable Connect the cable to the ECG patient monitoring input connector 3 Set the ECG simulator as follows Set To Heart Rate HR 30 BPM Lead select Il 4 Press the On Standby button to turn the monitor On 5 After the power up sequence verify the following monitor reactions a After at least five heartbeats the monitor displays a heart rate of 30 5 BPM b The audible alarm sounds and the Heart Rate frame flashes indica
104. period If pressed and held for 2 seconds or more the Audio Off con dition is initiated 12 3 LIFEGARD II Service Manual The NIBP button is connected to the processor Response of the processor depends upon the state of NIBP operation at the time and the action in pressing this button If momen tarily pressed less than 2 seconds a single NIBP measurement is obtained If pressed for 2 seconds or more the processor initiates a STAT monitoring sequence Pressing the NIBP switch at any time a pressure measurement is in effect causes the processor to ter minate the measurement and to deflate the cuff The Contrast button operates in conjunction with the navigation wheel to determine the apparent contrast setting in the display Changing the contrast is a change in the viewing angle Outputs of the button and wheel are connected to the processor Momentarily pressing the button changes the color of the background from A to B fac tory default value Momentarily pressing the button followed within 3 seconds by a rotation of the wheel enables varying the contrast of the display When there has been no wheel rotation for 3 seconds the contrast control function is terminated by the processor The contrast con trol function is also terminated if the wheel is pressed at any time within this 3 second interval The Volume button operates in conjunction with the navigation wheel to determine the volume of the heart rate audible tone Pressing t
105. pres sure of 0 mmHg or kPa by doing the following a Press the Contrast button on the monitor s front panel b If needed zero the simulator see To Zero the Simulator on Page 6 10 Press the NIBP button on the monitor s front panel to activate the pump and simul taneously start the timer Hold the button until the monitor displays a pressure of 250 mmHg 33 3 kPa then stop the timer The inflation rate should be between 1 and 6 seconds Press and hold the Volume button until the monitor displays a pressure of O mmHg or kPa If no further NIBP tests are to be conducted turn the monitor Off Normal monitoring operation returns the next time the monitor is turned On LIFEGARD II Service Manual 6 12 NOTE The pneumatic system includes an over pressure safety limit function and a safety period time out function These safety functions may interfere with NIBP tests described in this section In order to avoid activating these safety functions do not pressurize the system above 270 mmHg 36 kPa and do not pressurize the sys tem for time periods that exceed 150 seconds NOTE The over pressure relief may activate and automatically deflate the cuff For more information on the NIBP safety functions see page 6 10 Over Pressure Test This test verifies the functionality of the over pressure relief system of the monitor Step 1 Action Turn the simulator On 2 Perform the foll
106. r local Analogic representative for advice on remedial action 3 If the monitor powers up and the error code does not reoccur enter the Diagnostic Mode and select the Error Code option Examine the record of the last 10 error codes and determine if the same error code occurred previously 4 If the Error Code screen indicates that the same error code has occurred previously take the monitor out of service and contact the Analogic Life Care Systems support group or your local Analogic representative for advice on remedial action 5 If the Error Code screen indicates no previous occurrences of this error the monitor can be returned to service Disassembly 8 Disassembly This chapter provides step by step procedures that are used to access replaceable parts of the monitor The sections in this chapter describe and photographically illustrate pro cedures for disassembling the monitor in order to remove or replace suspected defective assemblies or components 8 1 Introduction The monitor consists of two main assemblies the front case assembly and the rear case assembly All part numbers and exploded views of some assemblies are located in Chapter 9 Spare Parts The monitor can be disassembled down to all major component parts including PCBs Battery Cables Function buttons Chassis enclosures 8 2 Tools Required The following tools are necessary to disassemble the monitor e 1 and 2 Philips screwdr
107. ram Protective Earth Electrical Leakage The following tests verify the electrical leakage of the monitor Earth Leakage Current Enclosure Leakage Current Patient Leakage Current Patient Source Current with Mains Voltage on the Applied Part WARNING N Perform all leakage tests any time the unit is opened Earth Leakage Current This test is in compliance with IEC 60601 1 Earth Leakage Current In locations where mains voltage is 100 120 volts the applied voltage is 132 volts In locations where mains voltage is 220 240 volts the applied voltage is 264 volts The applied AC frequency should be the same as the local mains 50 or 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 Earth leakage current is measured under various conditions of the AC mains and protec tive earth conductor For each condition the measured leakage current must not exceed that indicated in Table 6 4 6 25 LIFEGARD II Service Manual Table 6 4 Earth Leakage Current Values Test Condition Polarity Allowable Leakage Current Normal Normal 300 pA Reversed 300 pA S F C a Normal 1000 pA Open Supply Reversed 1000 pA a S F C Single Fault Condition Enclosure Leakage Current Th
108. re described in the next section These menus can be configured as desired 5 After making the desired change highlight Accept Current Settings Press the wheel to select this option 6 From the popup menu select Yes 7 Select Return After selecting Return a notice displays instructing you to power down the monitor Next time you power on the changes you made to the defaults are implemented Menu Options Configuring the Power up Defaults Menu Below are the menu options that can be configured from the Power up Defaults Menu Menu Item Choices Explanation Accept Current Settings Yes If Yes is chosen the current monitor settings become the power up defaults No Selected Audio Off Make Available default If Make Available is chosen audible alarms are per D A manently silenced for a particular parameter via the eny ACCESS Alarm Limits Menu Some institutions may want to prevent audible alarms from being permanently silenced If so select Deny Access Audio Off Make Available default If Make Available is chosen Alarm Suspend Mode Auto Set Limits Deny Access Make Available default Deny Access can be invoked by pressing and holding the Alarm Silence button for 2 seconds Some institutions may wish to prevent Alarm Suspend from being invoked If so select Deny Access If Make Available is chosen Auto Set Limits are invoked via the Alarm Limits Menu Some institutions may wish to preve
109. rway 6 14 Patient Safety Tests The safety tests meet the standards of and are performed in accordance with IEC 60601 1 Clause 19 EN60601 1 Second Edition 1988 Amendment 1 1991 11 Amendment 2 1995 03 The LIFEGARD II patient monitor is a Class I device It requires a protective earth ground wire Keep this in mind when performing the following test procedures There are two categories of safety tests Ground Integrity Electrical Leakage Ground Integrity Table 6 3 Ground Integrity Test or Inspection to Perform Expected Test Results Protective Earth See Safety Test Diagram Protective Earth on page 6 26 With mains cable Maximum impedance no greater than 100 mO Testing the Monitor Instrument under test L N e IM e Ri gt TT d PEC m Ohm 7 g 6V Insulating pad 50 Hz 25A or 1 5 Ir If equipotential connection present measure also with yellow green E P conductor connected Measures impedance of Protective Earth PE terminal to all exposed metal parts of IUT which are for safety reasons connected to the Protective Earth PE Max 100 mQ Test current 25 amps applied for 5 to 10 seconds We recommend to flex the main cable during the test in order to identify potential bad contact or damage of the earth wire Safety test according to EN60601 1 Clause 18 Figure 6 4 Safety Test Diag
110. s a full function monitor for use on adult and pediatric patients The functions performed by the system include monitoring patient ECG heart rate res piration rate blood pressure blood oxygen saturation and temperature Optional func tions could include CO and ICG In addition to monitoring and displaying the status of these physiological parameters the instrument performs various microprocessor programmed analytical functions such as Creating both visual and audible alarm signals when set limits are violated Creating and displaying warning messages when conditions are detected that would degrade or prevent valid measurements Creating and displaying trend waveforms or tabular data Providing input to an optional recorder for printout of current or trend waveforms or tabular data The monitor is essentially a battery powered instrument An internal charging unit is designed to accept an external AC line voltage The charger uses the external power source to maintain a float voltage source available to the battery 12 3 Block Diagram The functions are represented graphically in the following figure Each section of the System Block Diagram is described briefly in the text that follows the illustration This is followed by more detailed descriptions of the theory of operation of each block 12 1 LIFEGARD II Service Manual A gsn 0 1 19p10284 Jayeads
111. s from edge to edge Display backlight tube worn Replace backlight tube according to instructions in Replacing the Backlight Tube on page 8 5 Monitor screen is not lit Display backlight tube worn or loose connection Main PCB module malfunction 1 Check the backlight tube connector 2 Replace the backlight tube Replace the Main PCB module according to instruc tion in Removing the Main PCB Module on page 8 8 Monitor fails to power up when the On Standby button is pressed Battery is dead or monitor is not plugged in Keypad malfunction or keypad connector is loose Make sure the monitor is powered on by AC power Check that the battery is adequately charged and AC power fuses are securely connected 1 Check the keypad connector 2 Replace the keypad according to the instructions in Removing the Keypad on the Front Panel on page 8 3 No response when pressing the buttons on the front panel Keypad malfunction or keypad connector is loose 1 Check the keypad connector 2 Replace the keypad according to the instructions in Removing the Keypad on the Front Panel on page 8 3 Audible alarm does not sound Speaker malfunction or speaker has a loose connector Main PCB module malfunction 1 Check speaker connection 2 Replace speaker according to the instructions in Replacing the Speaker on page 8 5 Replace the Main PCB module according to the instructions in Removi
112. s located in this Service Manual where appropriate General This manual contains information for servicing the LIFEGARD II patient monitor Only qualified service personnel should service this monitor Before servicing the monitor carefully read the LIFEGARD II Operator s Manual for a thorough understanding of operation LIFEGARD I Patient Monitor Description The purpose and function of the LIFEGARD II family of patient monitors is to monitor ECG heart rate non invasive blood pressure NIBP functional arterial oxygen satura tion SpO respiration rate temperature and carbon dioxide CO for adult and pedi atric patients in the physician s office hospital areas and hospital type facilities such as clinics and to non invasively evaluate the hemodynamic status of adult patients in either the hospital or physician s office environment based on the measurement of thoracic electrical bioimpedance TEB 1 1 LIFEGARD II Service Manual 1 4 The intended users of the LIFEGARD II patient monitors are clinicians and nursing staffs within hospital out patient and ambulatory settings This monitor is not intended for helicopter transport or home use The physical and operational characteristics of the monitor are described in the LIFEGARD II Operator s Manual Features and Options The LIFEGARD II is available in the following models Model Description AN4320 Can be used to monitor ECG heart ra
113. s on the LIFEGARD II monitor are classified as type CF which specifies their degree of protection against electrical shock All are rated as defib rillator proof The following heart symbol is on the side of the monitor where the patient monitoring input connectors are located 4 H Each connection is identified by a unique icon describing the parameter being moni tored through that connector They are illustrated in the following table Introduction Monitored Parameter Connector Type Icon ECG and Respiration Use with LIFEGARD II ECG lead cable ECG Resp vECG and ICG Use with LIFEGARD II ICG lead cable ECG Resp CG Temperature Use Analogic temperature probes T SpOs Use with Analogic sensors and sensor extension cables SpO NIBP Compatible with recommended Analogic blood pressure tubing for LIFEGARD II EtCO Compatible with Oridion Microstream accessories CO WARNING IN Use only the approved accessories for the LIFEGARD II patient monitor 1 7 Rear of Monitor The following diagram is of the rear panel See Chapter 2 for an explanation of the sym bols located on this panel The LIFEGARD II s rear panel is shown below with its four connectors USB Equipotential AC input and RS 232 Q o000i 00 CE A ANALOGIC E LIFEGARD IT B D Callout Connector Connector Type L
114. sconnected pay particular attention to the polarity of the cable before reattaching If the battery cable polarity is reversed it is likely that circuit damage will occur Disassembly Procedures This section provides instructions for closed case front case and rear case disassembly procedures 8 4 1 Closed Case Disassembly Procedures This section describes the items that can be removed without disassembling the main case of the monitor Removing the Battery WARNING Before beginning any disassembly procedures the battery must be removed Disassembly Step Action 1 With the rear of the monitor facing you disconnect the battery cover from the rear panel using a Philips no 1 screwdriver to loosen the 4 captive screws fastening the battery cover Slide the battery out by tilting the monitor towards you Disconnect both battery lug terminals to release the battery When you re insert the battery verify that the battery is inserted the correct way and the polarity is correct see figure below Black Red Removing the Navigation Wheel Step Action 1 Firmly grasp both sides of the wheel and pull straight back from the monitor The wheel should slip off the encoder shaft 2 For further disassembly use the 5 8 socket wrench to unscrew the brass bushing NOTE The brass bushing adheres to the front case by an adhesive ring the Encoder Bushing Adhesive
115. sure the change that occurs in a patient s thoracic fluid content The outer electrodes inject a small electrical current 1 mA through the thorax This signal cannot be felt by the patient The inner electrodes receive the transmitted signal to measure impedance 12 5 LIFEGARD II Service Manual As velocity and volume of blood in the aorta change ICG measures the changes in impedance from systole to diastole to calculate hemodynamic parameters Impedance as it applies to ICG is the resistance to the flow of an electrical current Depending on the impedance to flow of the injected current the monitor records changes and displays these changes in the impedance waveform ICG can be used to continuously monitor cardiac output thoracic fluid content stroke volume and a variety of contractility indices 12 17 Respiration Processing The patient s respiration is detected by using two of the three leads of the ECG elec trodes and cable A low level excitation signal is applied to these leads and the variation of the thoracic impedance caused by the breathing is sensed and processed for display and measurement 12 18 NIBP Processing The NIBP processing uses an oscillometric technique to provide needed measurements at selected intervals This technique uses an inflatable sphygmomanometer cuff similar to those used by clinicians in routine measurements A motorized pump inflates the cuff to approximately 180 mmHg initially a
116. t Place sensor on another site SpO Non Pulsatile Pulse is too weak or is not detectable or the application site is too thin Change the application site of the sensor or stimulate circulation at the current site SpO Sensor Malfunction Sensor is malfunctioning 1 Change the SpO2 sensor as soon as possible 2 Return the faulty sensor to your biomedical department Temperature Probe Disconnect Monitor is not detecting temper ature reading Check that the temperature probe is properly connect ed to the monitor 7 4 Troubleshooting The following table can be used to solve problems that may occur in the monitor Isolating the Defective Component Symptom Cause of Failure Remedy The battery symbol is not displayed A battery is not present in the monitor the battery is defective or there is a bad connection Install a charged battery see Removing the Battery on page 8 2 If a battery is already present remove it and refit the battery making sure to push it completely into position Check the connection wires to make sure wires are secured to to the battery Some or all numerics or waves are not dis played Parameters are switched off No accessories are connected Switch on parameters Connect the required accessories If connections are Secure replace the suspect accessory Monitor screen appears dim or brightness decrease
117. t which point the pressure effectively stops the flow of blood Then under monitor control the pres sure in the cuff is gradually reduced in steps while a pressure transducer detects the air pressure and transmits the parameter signal to the NIBP input circuitry As the pressure is reduced blood flows in the previously occluded artery and changes the measurements made by the transducer The point at which oscillation increases sharply is defined as systolic pressure As the cuff continues to deflate oscillation amplitude increases to a maximum and then decreases The peak oscillation amplitude is defined as the mean arterial pressure The point at which the system detects a rapid decrease in oscillation is defined as the diastolic pressure 12 19 SpO Processing Measurement of oxygen saturation in the blood uses a specrophotometry technique It is based on the fact that oxyhemoglobin differ in their absorption of red and infrared light and that the volume of arterial blood in tissue changes during the pulse Using these facts a pulse oximeter passes red and infrared light into an arteriolar bed and measures changes in light absorption during the pulsatile cycle The light sources are red and infrared light emitting diodes LEDs while the detection is accomplished by a photo diode To identify the oxygen saturation of arterial hemoglobin the monitor uses the pulsatile nature of arterial flow During systole a new pulse of arterial bl
118. te non invasive blood pressure NIBP respiration rate and temperature AN4320P Includes all the features and functionality found in the AN4320 but can also generate recordings and print them to the optional internal strip recorder See Recording and Printing Trends for more infor mation on recorders AN4321P Includes all the features and functionality found in the AN4320 but also integrates a EtCO measure ment from Oridion Can be used as a general purpose patient monitor or for procedural sedation in anesthesia Can generate recordings and print them to the optional internal strip recorder See Recording and Printing Trends for more information on recorders AN4322P Includes all the features and functionality found in the AN4320 but also integrates ICG Impedance Cardiography It can be used to generate recordings on the strip chart recorder See Recording and Printing Trends for more information on recorders The AN4322P can also print reports on an exter nal ink jet printer if available See operator s manual Chapter 16 for more information on printing reports Note The AN4322P in ICG mode does not monitor respiration AN4323P The AN4323P model offers both the EtCO and ICG capabilities The cable configuration determines which function is currently being used Also includes internal strip recorder 1 Carbon Dioxide monitoring is available in the AN4321P and the AN4323P models only 1 2
119. tected and displayed NIBP Non Invasive Blood Pressure Parameter Specification Standards Meets performance standards of ANSI AAMI SP 10 2002 Technique Oscillometric Maximum Cuff Pressure 300 mmHg Cuff Pressure Display Range 10 to 330 mmHg Pulse Rate Range 40 to 200 b min Blood Pressure Accuracy Mean error and standard deviation per ANSI AAMI SP10 20022 Pulse Rate Accuracy Greater of 2 bpm or 2 Factory Default Initial Cuff Inflation 160 mmHg adult mode 120 mmHg pediatric mode Subsequent Cuff Inflation Prev SYS 30 mmHg Blood Pressure Measurement Display Range Systolic 40 to 250 mmHg Diastolic 20 to 200 mmHg Mean Arterial Pressure 27 to 220 mmHg Measurement Modes Auto Automatic measurements at intervals of 1 3 5 10 15 30 60 and 90 minutes Manual Single measurement initiated by Start Stop button STAT Series of consecutive measurements for 5 minutes a 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 Temperature Parameter Specification Technique Probe YSI 400 Series Thermistor Range 15 to 45 C 59 113 F Accuracy 0 1 C 0 18 F 13 5 LIFEGARD II Service Manual SpO Paramet
120. th an OR ECG cable set This is because of the higher internal impedance of the OR cable set required for use if electro surgery is being performed WARNING A Ensure that conductive portions of the electrodes leads and cable do not come into contact with any other conductive parts WARNING For pacemaker patients the monitor can continue to count pacemaker rate during cardiac arrest or some arrhythmias Do not rely entirely upon the monitor s alarm Keep pacemaker patients under close surveillance WARNING Line isolation monitor transients may resemble actual cardiac waveforms and thus N inhibit heart rate alarms Such transients may be minimized by proper electrode and cable placement as specified in this manual and electrode directions for use WARNING ECG cables may be damaged when connected to a patient during defibrillation Check cables that have been connected to a patient during defibrillation for func tionality before using them again WARNING Monitoring with the Pacer Detect feature enabled does not normally affect the N monitoring of non pacemaker patients However in some instances if the patient does not have a pacemaker it can be desirable to turn the detection function Off so that artifacts in the waveform are not mistaken for a pacemaker signal WARNING Do not use with minute ventilation adaptive pacemakers The injected current may uN cause this type of pacemaker to malfunctio
121. that the mode is operating properly If one or more of the B C and X marks fail to display on the Signal Quality Indicator SQI your readings could be inaccurate and or you may be unable to obtain accurate values for stroke volume and other hemodynamic parameters 2 9 LIFEGARD II Service Manual 2 10 2 4 WARNING N Anyone who connects additional equipment to the signal input port or signal output port configures a medical system and is therefore responsible to ensure that the system complies with the requirements of system standard IEC 60601 1 1 If in doubt consult Analogic Corporation or your local Analogic Corporation represen tative WARNING uN It is the user s responsibility to ensure that the monitor and the user s defibrillator perform safely and effectively when connected WARNING Improper operation can result in harm to the patient WARNING N Two or more medical electrical equipment devices connected to a patient at the same time can cause signal interference WARNING It is not recommended that this device be used with any unauthorized consumable CO sampling products which are not manufactured by Oridion Medical 1987 Ltd Cautions Caution Do not connect this monitor to any other equipment or device other than those specified in this Operator s Manual Caution Sterilization is not recommended for this monitor related products accessories or j supplies unless otherwise in
122. the leads is not Make sure that the ICG patient cable is connected to connected to the patient the monitor and the patient leads the leads are con nected to the sensors and the sensors are firmly attached to the patient Low ICG Amplitude Low or poor signal quality Check the patient Check the integrity of electrode lead and cable connections See ICG Leads Off Try to reposition the electrodes Loss of Pulse from SpO SpO cannot find a pulse Make sure the SpO patient cable is connected and the sensor is correctly attached to the patient Try new location LIFEGARD II Service Manual Technical Alarm Messages continued to patient motion or physiology Message Cause of Failure Remedy Low Battery The battery has less than 30 Recharge the battery minutes of charge left NIBP Artifact Incomplete measurement due 1 Check the patient 2 Check cuff application and orientation NIBP Blocked Hose NIBP No Cuff NIBP tubing blocked mea surement not possible Monitor unable to detect NIBP cuff Check that the tubing is not obstructed or pinched 1 Check to see that cuff is present 2 Check cuff and tube connections for leaks NIBP Overpressure This message appears when the NIBP cuff pressure increas es above overpressure safety limits Remove the cuff from the patient Make sure the rub ber tube to t
123. ting Safety Information 0 eee eee 6 1 6 3 ODJOCHVES sid code zen P ba Doa lead eee E E A 6 1 64 Testing Checklist eaii od seeds e ee dee eaten daa eed 6 2 65 Recommendations for Testing Frequency 020004 6 3 66 Test Map viscsas i civiareisas ive E GU dae E ddan IKE E d redd 6 4 6 7 EQUIPMENt x iei mae erect eda eee a ee 6 5 6 8 Serial Numbers 0 0 cece ccc ccc hee 6 6 69 Visual Test 23 cscs eere de RR Re eg 6 6 6 10 Passwords sii eck RR adie eta Ge yaad a beens e Gs b 6 6 6 11 Functionality Assurance Tests 20 0 0c eee eee eee ee 6 7 6 12 Preventive Maintenance Tests 0 0 c eee EEren iE 6 9 6 13 Performance Procedures 0 0 eee eee eee ee eee 6 14 6 14 Patient Safety Tests cece eens 6 24 740 Troubleshooting i sieciee s ke Ree RR E Ce E LER E ES 7 1 7 1 General Troubleshooting Safety Information 7 1 12 ODJCCUVES ciun a veta ade Oel Sigs hee 7 1 1 3 Concepts caei esce e e Por RACE we d Oed Reb RE Ye 7 1 74 Part 1 Troubleshooting Checklist lllsllleeeeeeese 7 2 7 5 Part 2 Isolating and Solving Monitor Problems 7 3 7 6 Part3 Using Support Functions 2 0 0 0c eee eee eee 7 7 S10 Disassembly ssid tee evn wh td og d reb e vit oe ese ciere x rere s 8 1 5 1 AMMOGUCHON 229a esos ded an cedem s den de 8 1 82 Tools Requires 5 od Rr e e oe AC ve Ee Re eed 8 1 83 Disassembly
124. ting heart rate is below the default lower alarm limit 6 Press the Alarm Silence button twice on the monitor s front panel to invoke the Silence Reset mode 7 Increase the heart rate setting on the ECG simulator to 250 BPM After at least five heartbeats verify that the monitor displays a heart rate of 240 5 BPM 8 Verify that the audible alarm sounds and the Heart Rate frame flashes indicating that the heart rate is above the default upper alarm limit 9 Press the Alarm Silence button twice on the monitor s front panel to invoke the Silence Reset mode 10 Decrease the heart rate setting on the ECG simulator to 120 BPM After at least five heartbeats verify that the monitor displays a heart rate of 120 5 BPM 11 Disconnect the LL lead from the ECG simulator Verify that the Leads Off alarm message displays displays in the Heart Rate frame and the low priority Leads Off INOP sounds 12 Reconnect the LL lead to the ECG simulator Verify that the Leads Off alarm mes sage no longer displays and the audible alarm is silenced 13 Repeat steps 11 and 12 for LA and RA leads then turn your monitor Off Testing the Monitor Respiration Test The accuracy of the monitor s respiration measurements is 3 breaths per minute In the procedure below add the tolerance of the simulator to the acceptable range of readings Step Action 1 Verify that the monitor is in Standby Con
125. tinue flashing d The HR tone remains audible e The audible alarm returns within 120 seconds 6 12 Testing the Monitor Volume Control Test Tools Needed e SpO Extension Cable 10 64075 02 Clinical Dynamics Corp SmartSat simulator with Nellcor simulator cable Step Action 1 Connect SpO simulator cable to the SpO adapter cable Connect the cable to the SpO patient monitoring input connector 2 Set the simulator as follows Item Setting Oximeter N Oximax SpOs 6 81 BPM 70 Pulse Mod 5 0096 3 Power the monitor On Verify that the values are within the following tolerances Oxygen Saturation Range 79 to 83 Heart Rate Range 67 to 73 BPM 4 Press the Alarm Silence button to temporarily silence the audible alarm 5 Verify that the heart rate tone source found in the Heart Rate Menu is set to SpOs 6 Press the Volume button on the monitor s front panel Within 3 seconds of having pressed the button rotate the navigation wheel clockwise to verify that the beeping heart rate tone sound level increases 7 Wait 3 seconds Press the Volume button and rotate the wheel counter clockwise and verify that the beeping heart rate tone decreases until it is no longer audible Rotate the wheel clockwise to return the beep volume to a comfortable level After 3 seconds with no wheel activity the volume adjust function terminates Preventive Maintenance Tests Preventi
126. to VDC at a range of 10 volts 4 Connect the DMM negative lead to connector pin 5 GND or the shell of the RS 232 connector 5 Referring to Table 6 2 Serial Interface Voltages connect the DM positive lead to each pin in turn and verify the voltage values listed Voltage for pin 9 is that listed from the No Alarm condition 6 Connect SpO simulator cable to the SpO adapter cable Connect the cable to the SpO patient monitoring input connector 7 Set the simulator switches as follows Item Setting Oximeter Nellcor SpO2 6 81 BPM 36 Pulse Mod 0 5096 8 Verify that the monitor is responding to the SpO simulator signal and the audible alarm is sounding If desired press the Alarm Silence button to temporarily silence the audible alarm 9 Connect the DMM positive lead to pin 9 and verify the voltage value listed in Table 6 2 Serial Interface Voltages The voltage for pin 9 is that listed for the Alarm Underway condition 6 23 LIFEGARD II Service Manual 6 24 Table 6 2 Serial Interface Voltages Measurement V Pin Signal Direction Min Typical Max 1 not used 0 4 0 0 0 4 2 RXD input 0 4 0 0 0 4 3 TXD output 0 5 7 1 7 25 4 DTR output 5 0 7 0 15 0 5 GND 0 4 0 0 0 4 6 DSR input 0 4 0 0 4 0 7 RTS output 5 0 7 1 7 25 8 CTS input 0 4 0 0 0 4 9 Alarm Out output 5 0 7 1 7 25 no alarm 9 Alarm Out output 5 0 7 1 7 25 alarm unde
127. to disappear Select the value for the calibration gas the default value is 5 Select Start Calibration and press and hold the valve on the calibration gas to allow CO gas to flow into the monitor Allow the value to stabilize before the start of the calibration Hold the valve open until the monitor gives a prompt that the gas can be removed The CO module calibrates and prompts when calibration is successful Figure 6 3 Connecting the Calibration Gas to the LIFEGARD II 6 22 Testing the Monitor Calibration Verification Step Action 1 Depress button on the 5 gas valve and allow the value to stabilize 2 Check that the value displayed on the monitor is correct and within the tolerance see Step 2 in previous section Serial Interface and Nurse Call Signal Test Perform the following procedure to test the serial port voltages The test is qualitative and only verifies that the serial interface port is powered correctly and that the Nurse Call signal Pin 9 is operational The serial connector is a male DB 9 located on the monitor s rear panel identified by the RS 232 symbol Tools Needed Clinical Dynamics Corp SmartSat simulator with Nellcor simulator cable e SpO extension cable 10 64075 02 Step Action 1 Verify that the Nurse Call Signal is On in the setup menu 2 Turn the monitor On 3 Set up the DMM with the function set
128. tor s AC mains power cord to the analyzer as recommended by analyzer operating instructions 3 Connect the ECG test cable between the ECG connector on the monitor and the appropriate input connector on the analyzer 4 Turn the monitor On 5 Perform the test as recommended by the analyzer operating instructions 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 below 6 Repeat the test for SpO and temperature patient connections using appropriate test cables Table 6 6 Patient Leakage Current Values Test Condition Polarity Allowable Leakage Current Max Type CF Normal Normal 10 yA Reversed 10 yA S F C Open Normal 50 uA Earth Ground Reversed 50 LA Patient Leakage Current with Mains Voltage on the Applied Part This test measures patient leakage current in accordance with EN60601 1 Clause 19 for Class I type CF equipment In this test 110 of mains voltage is applied between each patient connection and earth power ground Patient leakage current is then mea sured from any individual patient connection to earth WARNING AC mains voltage is present on the applied part terminals during this test Exercise caution to avoid electrical shock hazard Table 6 7 Safety Tests Patient Leakage Current with Mains Voltage on the Applied Part
129. tware for the NIBP module This value CANNOT be changed Exits the System Information Menu and returns to the Diagnostic Menu System A D Values The System A D screen displays the current value of each analog to digital A D chan nel in volts Some of the channels are for AC coupled signals such as ECG input so the numbers on the screen are constantly changing when an input signal is present These AC coupled values are shown to give an indication as to whether basic function ality of the channel is present but no significance can be derived from the values of the numbers displayed DIAGNOSTIC MENU SYSTEM A D VALUES 1 0 000 12 2 025 2 3 270 13 0 000 3 2 495 14 0 000 4 2 275 15 1 815 5 0 000 16 2 782 6 3 280 T7 0 007 7 2 048 18 4 050 8 0 000 19 0 003 9 0 000 20 3 995 10 2 048 21 2 004 11 2 048 22 4 049 23 4 051 SpO S1 SpO Alive SpO2 S2 No Sensor Return Configuring the Power up Defaults Menu The Primary and Secondary Status messages from the SpO module are displayed and updated at the rate of about once per second Presence of the correct SpO message indi cates that at a basic level communication between the SpO module and the main mon itor processor is working correctly None of the displayed values can be changed or reset in this screen When in the System A D screen the Return option is always highlighted Press the wheel to return to the Diagnostic menu Rot
130. use 2 Inspect all accessories cables and sensors external to the monitor referring to the accessories documentation 3 Switch the monitor On and verify that the backlight is bright enough Check that Screen is at its full brightness If the brightness is not adequate contact your bio medical department The Life Care Systems Support Group recommends replacing the backlight about every 4 years 4 If you are operating the monitor from battery verify that the battery is adequately charged before you begin use Inspecting the Cables and Cords If a problem is discovered while inspecting the cables and cords replace the cable or contact your biomedical department Step Action 1 Examine the power plug and cord for damage Make sure that the prongs of the plug do not move in the casing If damaged replace the entire cord with the appro priate Analogic power cord See spare parts Section 19 of Operator s Manual 2 Inspect the patient cables and leads and their strain reliefs for general condition Make sure there are no breaks in the insulation Make sure that the connectors are properly engaged at each end to prevent rotation or other strain 3 With the sensor or electrodes applied to the simulators see Section 5 and the monitor turned On flex the patient cables near each end to make sure that there are no intermittent faults Cleaning Caution Do not immerse the monitor in
131. ve maintenance refers specifically to the service tests required to make sure the monitor measurement results are accurate In cases where the performance of NIBP is in question or could have been configured during repair the complete set of NIBP tests described in this service manual should be used See page 6 7 The tests in this section verify the functionality of the monitor s pneumatic system AII of these tests with the exception of the Basic Pneumatic Leakage BPL Test require the use of an NIBP simulator NOTE The monitor must be placed in Diagnostic Mode with the NIBP test screen active for each of the NIBP tests To place the monitor into this mode see page 6 4 Tools Needed for NIBP Testing e NIBP cuff AN4K AC017 e NIBP tubing AN4K AC019 Bio Tek BP Pump 2 simulator or equivalent with an internal test volume of 310 ml and CONDEC Model DLR334 Pressure Indicator 6 9 LIFEGARD II Service Manual Pneumatic System Functionality The following tests must be performed to verify pneumatic system functionality Perform these tests in the following order 1 Pressure Transducer Accuracy 2 Pneumatic Leakage 3 Inflation Rate 4 Over Pressure 5 Deflation Rate Pressure Transducer Accuracy Test This test verifies the pressure accuracy of the monitor s pressure transducer Step Action 1 Place the monitor in Diagnostic Mode with the NIBP test screen active 2 Confirm that th
132. veral system related items They are as follows Menu Item Monitor On Time Function Displays the number of hours rounded to the nearest hour that the Main PCB has been operational This value CANNOT be reset Backlight On Time Displays the number of hours rounded to the nearest hour that the LCD Backlight has been operational This value can be reset to zero An example is when a technician changes the backlight or installs a new LCD Recorder On Time Displays the number of hours rounded to the nearest hour that the recorder has been operational This value can be reset to zero An example is when a technician installs a new recorder Battery Deep Discharges Displays the number of deep discharge cycles seen by the bat tery When this point is reached a Low Battery alarm is issued This value can be reset to zero An example is when a technician installs a new battery System Software Version Displays the revision level of the system software The revision level is also momentarily shown on the LCD as part of the copyright screen The value CANNOT be changed CO Software Version Displays the revision level of the software of the Oridion CO module This value CANNOT be changed SpO Software Version Displays the revision level of the software of the MP 100 SpOs module This value CANNOT be changed NIBP Software Version Return Displays the revision level of the sof
133. verify performance fol lowing repairs or during routine maintenance All tests can be performed without disas sembling the monitor If the monitor fails to perform as specified in any test repairs must be done to correct the problem before the monitor is returned to the user Testing Safety Information WARNING Perform all leakage tests any time the unit is opened AC mains voltage is present on the applied part terminals during this test Exercise caution to avoid electrical shock hazard Objectives Functionality Assurance This refers to the combined Performance Assurance Test and Functionality Testing Procedures found in this chapter These tests verify correct monitor functionality in gen eral terms Preventive Maintenance Preventive Maintenance refers specifically to the service calibration tests required to ensure the monitor measurement results are accurate Performance and Safety Tests This refers to all the remaining accuracy and performance tests available on the monitor including safety tests and checks for the monitor 6 1 LIFEGARD II Service Manual 6 4 Testing Checklist The tests described in this chapter are listed in the table below Use this table as a checklist Check If Topics See Page Completed Date Completed Functionality Assurance Tests Functionality Assurance Test 6 7 Power On Self Test 6 7 Alarm Test
134. vershoot Following are pacer pulse conditions that the monitor will reject but which are less than the maximum range listed in the standard Pacer pulse width 2 ms Double pulse either Pacer amplitude lt 400 mV 150 or 250 ms apart without over undershoot no QRS Pacer pulse width 2 ms Double pulse 250 ms apart Pacer amplitude lt 500 mV without over undershoot ineffective pacer Pacer pulse width 2 ms Single or Double pulse either Pacer amplitude lt 100 mV 150 or 250 ms apart with 2 mV over undershoot no QRS Pacer pulse width 2 ms 250 ms spaced double pulse Pacer amplitude lt 200 mV with 2 mV over undershoot effective pacing Pacer pulse width 2 ms 150 ms spaced double pulse Pacer amplitude lt 90 mV with 2 mV over undershoot ineffective pace Pacer pulse width 2 ms 250 ms spaced double pulse Pacer amplitude lt 160 mV with 2 mV over undershoot ineffective pace Pacer pulse width 2 ms Double pulse 150 ms apart Pacer amplitude lt 600 mV with 2 mV undershoot positive pulse only effective pacer Pacer pulse detector rejection of fast ECG signals 50 pacer pulses triggered for ECG rise times of 5 volts second Specifications Respiration Parameter Specification Technique Trans thoracic impedance Range 3 to 150 breaths min Accuracy 3 breaths min Leads RA to LL Display Sweep Speeds 6 25 12 5 25 mm s Lead Off Condition De
135. viceable Hardware Error Codes Hex Code Explanation Recommended Action 1 Improper shutdown 1 Power cycle 2 If this error persists return the monitor to the Analogic Life Care Systems support group or your local Analogic representative 4 The measured value for the 1 Check the power supply SSV power SUPPIY IS 10W 2 Replace the power supply module 5 The measured value for the 1 Check the power supply 3 9 V power supply 1S high 2 Replace the power supply module 8 The measured value for the 5V 1 Check the power supply power supply is low 2 Replace the power supply module 9 The measured value for the 5V 1 Check the power supply power supply is high 2 Replace the power supply module E A checksum error is detected 1 Turn power Off M Meridie setings region 2 Turn power On while pressing both the Contrast and Volume buttons simultaneously See Restoring Factory Settings on page 6 XX 3 All user selections must be restored 4 If problem persists replace main PCB module 64 The SpO module is sending an 1 Ensure SpO module is properly connected error message to the host CPU 2 Replace the SpO module 3 If problem persists replace main PCB module The CO module is sending an 1 Ensure Oridion module is properly connected omarmessage 0 He Nost CMU 2 Replace the Oridion module 3 If problem persist replace main PCB module 65 66 SpO module has detected an 1 Replace SpO module
136. w label for 8 8 amp 8 9 AN4320 AN4320P 10 64663 02 Side Panel w label for AN4321P 10 64663 03 Side Panel w label for AN4322P 10 64663 04 Side Panel w label for AN4323P 8 10 64653 01 NIBP Assembly Components 8 11 9 10 63600S 01 Patient I O Module 8 9 10 10 63601S 01 Patient Daughterboard No Procedure Displayed Assembly 11 10 43248S Power Supply Assembly 8 11 Not Shown 10 60192S 03 Communication Board 8 11 Figure 9 6 3 of 3 Spare Parts 9 5 LIFEGARD II Service Manual 9 7 Rear Case Kit The Rear Case Kit 10 64661 01 contains all the parts that comprise the rear case The table below calls out the contents Order 10 64661 01 Rear Case Kit Quantity Description Rear case molded Handle vent molded Gasket silicone 0 07 in D x 34 in L 2 Foot pads 2 Machine screw SEMS PHCR 6 32 x 3 8 SS 9 8 Chassis Case Kit The Chassis Kit 10 64662 01 contains all the parts associated with the main chassis The table below call out the contents Order 10 64662 01 Chassis Kit Quantity Description 1 Rear label 1 Rear chassis 1 Battery door 1 Battery housing 2 Battery door pads 1 Battery insulator 1 Battery door label 1 Ground plug M Washer M6 DIN6798J BR NP M nut M6 DIN439B SS 9 9 Additional Spare Modules Page Ref for Part Number Description Disassembly 10 64651 01 SpO Module page 8 10 10 64652 01 CO Module for
137. ways present in the ECG display along with the ECG size setting expressed in mV cm The following information references particular sections of ANSI AAMI EC13 2002 Respiration waveform A 76 8 kHz square wave is used to inject 50 vA p p differentially 4 1 2 1 b between RA and LL Leads off Sensing 100 nA DC current Tall T wave rejection 4 1 2 1 c T wave of 0 8 mV amplitude will not affect heart rate determination Heart rate averaging Averages six of the most recent eight detected R R intervals 4 1 2 1 d excluding the longest and shortest of the eight intervals Response to irregular a Ventricular bigeminy 80 b min rhythm rhythms b Slow alternating ventricular bigeminy 60 b min 4 1 2 1 e c Rapid alternating ventricular bigeminy 80 to 103 b min d Bi directional systoles 134 to 151 b min Heart rate meter response time a Change from 80 to 120 b min 4 to 5s b Change from 80 to 40 b min 6 to 8s Time to alarm for Waveform 4 a Amplitude Average Time to Alarm tachycardia 0 5mV 6 6s 4 1 2 1 g 1 0 mV 4 0s 2 0 mV 22s Waveform 4 b Amplitude Average Time to Alarm 1 0 mV 3 0s 2 0 mV 14s 4 0 mV 1 0s Standards Pacemaker pulse rejection 4 1 4 1 4 1 4 2 With the exceptions noted below the monitor will reject all single and double pacemaker pulses either 150 or 250 ms apart of amplitudes 2 to 700 mV from 0 1 to 2 0 ms with and without under o
138. ween 0 and 4 ml minute If the value is not within the tolerance limits there is a leak between the pump outlet and the CO module gas outlet If a leak is found in Step 3 open the CO module and check the tubing connections at the pump outlet and the module CO gas outlet If the connections are good then there is leakage in the module and the CO module must be exchanged 6 20 Testing the Monitor Part 2 Step Action 1 Disconnect the flowmeter from the Part 1 setup and connect the flowmeter inlet to the CO module gas outlet Refer to figure 6 3 2 Leave the FilterLine connected to the CO module inlet Leave other end of line open 3 Block the inlet of the FilterLine using your fingertip and observe the flowmeter dis play The value on the flowmeter should decrease to between 0 and 4 ml minute If the value is within the tolerance limits there are no leaks and the leak check is com pleted Proceed to the Pump Check 4 If the value is not within the tolerance limits there is a leak between the FilterLine inlet and the pump inlet 5 Check the FilterLine connections and open the monitor to check the tubing connec tions at the pump inlet and the CO module gas inlet If the connections are good try replacing the FilterLine and repeating the leakage check If the situation remains there is a leak in the tubing and the CO module must be exchanged Pump Check Step Action

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