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Service Manual 

for 

BodyGuard 323, 545, & 575 

Infusion pumps 

 

      

   

 

 

 
 

0344 

 
                    

 

 

   

Manufacturer:

 

 

Caesarea Medical Electronics Ltd. 

   

 

 

International Toll Free: +800-323-575-00

 

European address: 
Staufenburgstr. 23 Lichtenstein         
P.o.b. 1248 Lichtenstein 72805 Germany 

 

 
         

    PN 100-091X ver. 191009

 

E

-mail: [email protected] 

www.cme-infusion.com

 

                             
 

Содержание BodyGuard 323

Страница 1: ...mps 0344 Manufacturer Caesarea Medical Electronics Ltd International Toll Free 800 323 575 00 European address Staufenburgstr 23 Lichtenstein P o b 1248 Lichtenstein 72805 Germany PN 100 091X ver 191009 E mail sales cme infusion com www cme infusion com ...

Страница 2: ...rocess Diagram 7 Tools and Test Equipment 10 Adjustable Operating Parameters and Options 12 Operational Checklist and Performance Acceptance Test 19 Calibration 22 Troubleshooting 29 Service actions 34 Service Center Recommended Parts 48 Cleaning and Storage 48 APPENDIX A 49 ...

Страница 3: ...f BodyGuard pumps chargers and accessories may only be performed by CME authorized service personnel Service can only be performed with the recommended equipment and CME approved parts This manual is intended to support CME authorized service technicians performing service Clinical personnel patients and other users are advised to return pumps to an authorized service center for service Refer to o...

Страница 4: ...tant precautions The maximum volume that may be infused under SINGLE FAULT CONDITION is 0 1 ml Voltage present on internal components may cause severe shock or death upon contact Disconnect the charger from AC power prior to opening the casing Only authorized service personnel should open the pump cover Blown fuses could cause a fire hazard Replace blown fuses on the charger only with fuses of the...

Страница 5: ...cessories Use only accessories and options designed for this system and supplied by manufacturer The BodyGuard tubing sets should not be use for blood blood products or nitroglycerin administration Battery charging is enabled as long as the charger cord is connected to AC power and the pump is in the charger Switching the pump off does not disconnect it from AC power To disconnect from AC power re...

Страница 6: ...ump with the battery fully depleted Xylene acetone or similar solvents could cause damage to components Do not clean the pump with these chemicals Clean solution spills on the pump immediately Use a damp cloth or sponge A mild detergent may be used Wipe thoroughly with a dry cloth Immersing the BodyGuard Infusion pump into liquid could cause damage to components Do not immerse the pump into any ty...

Страница 7: ...of 50 7 Service Process Diagram The service operation is diagrammed below ...

Страница 8: ...cribed in the user manual 4 Open a service file to include all required documentation 5 Download or View the Event Log The event log records program and calibration settings and notes the frequency and nature of any alarms alerts that may be associated with past pump performance or a complaint Download the Event Log a Use the BodyComm Software and Communication charger b Refer to the BodyComm Oper...

Страница 9: ...ntil the Technician Code prompt appears b Enter Technician Code c Scroll to Manual Calibration and record all pump calibration settings volume and pressure calibration by pressing START OK continuously to review each setting d Scroll to and perform Main Self Test and record any failures or issues identified during the test 6 Review Customer supplied Service Request Information a Has the user opera...

Страница 10: ...0 318X BodyGuard Charger may be required pulse oximeter charger for 545 and 575 RS 232 cable 197 000X ESD work station Mat and Wrist Strap BodyGuard tubing set with proximal Y Site Infusion Bag sterile water for injection Scale 01g resolution Pressure Gauge maximum pressure 30psi 01 psi resolution Timer seconds resolution Burning Station PN 100 405X for software updates 5 pin male to male connecti...

Страница 11: ...Equipment Note CME prefers the download of the pump settings event log and or history review be performed with BodyComm Software available from CME However when the software is not available the review and or download can be performed manually ...

Страница 12: ...librated or tested The technician can scroll through all parameters using the ARROW keys 2 0 keys on the pump Item Parameter Description 1 Restart Pump Exit Technician Mode 2 Serial Number Displays serial number production date 3 Manual Calibration Summary of volume pressure calibrations and ability to check re enter software default calibrations after service 4 Main Self Test Performs keypad disp...

Страница 13: ... Allows clinical personnel to set maximum bolus volume 0 100 ml 6 titration bolus Allows clinical personnel to set titration bolus On Off 7 bolus rate Allows clinical personnel to set bolus rate 0 1200 ml h 8 maximal rate Allows clinical personnel to set maximal rate 0 1 1200 ml h 9 KVO rate Allows clinical personnel to set KVO rate 0 0 5 0 ml h 10 flow control Allows clinical personnel to set flo...

Страница 14: ...Item Parameter Description 1 Locks ability to change programs Enables clinical personnel to lock out the pump so that programs can only be started or stopped Keypad Lock To access Keypad Lock 1 With the pump operating in normal operation mode to activate the Keypad Lock Press and Hold the INFO Key until the bar graph is filled 2 Repeat step 1 to deactivate The Keypad Lock is intended for use by cl...

Страница 15: ...an Mode 2 Serial Number Displays serial number production date 3 Manual Calibration Summary of volume pressure calibrations and ability to check re enter software default calibrations after service 4 Main Self Test Performs keypad display alarm sound door sensor air sensor temperature motor encoder and pressure sensor tests 5 Volume Test Program rate volume to be delivered during flow rate test 6 ...

Страница 16: ...o 3 Start Infusion Ok No 4 Modify Protocol Allows clinical personnel to modify protocol by entering Admin Code 5 Clinician Bolus Allows clinical personnel to deliver a bolus regardless of preset limits by entering Clinician Activated Bolus Code 6 Patient History Allow clinical personnel to display infusion history for last 24 hours 7 Event Log Allow clinical personnel to review event history setti...

Страница 17: ...essure 545 7 14 21psi 575 5 7 5 10 psi 4 Priming Volume 0 20 ml 5 Priming Rate 300 1200 ml h 6 Max CA Bolus disable limit max clinician bolus dose to 0 20 ml 7 Default Bolus Rate 0 1000 ml h 8 Maximum Basal Rate 0 0 30 ml h 9 KVO Rate 0 0 5 0 m h 10 Program Limits Set MediGuard limits for body weight On Off 11 Air In Line Limits 0 0 1 0 ml 12 LED Indicator Set operational indicator LED On Off 13 B...

Страница 18: ...ph is filled 2 Repeat step 1 to deactivate The Keypad Lock is intended for use by clinical personnel and authorized service techncians Item Parameter Description 1 Locks all keypad buttons except the INFO START OK and STOP keys Enables clinical personnel to lock all buttons but the INFO START OK and STOP keys to prevent tampering with the pump during normal operation ...

Страница 19: ...cts i e sets etc Devices subject to complaint evaluation should be tested to try to duplicate the customer s complaint Once the complaint evaluation with the associated product has been completed the device should be retested without the associate product to the normal service process 1 Main Self Test a Keypad test Tests operation of all keypad keys i Test passes if all keys work b Display Test Te...

Страница 20: ...reen charge indicator light turns on c Program pump to 1200ml hr d Start pump and start timer and run to End Battery e Record time to discharge pump f If battery ran for at least 3 hours battery passes if battery did not replace battery 5 Restore Software Default Settings page 46 a Check software default settings are restored User programmable protocols should be blank b Test is passed if they are...

Страница 21: ... a Perform Occlusion Pressure Calibration procedure to obtain assessment b Occlusion pressure test passes if pressure limit 2 psi is achieved 10 Ground Strap Test a Test continuity between center charger connector pin and door hook If no continuity ship to CME America for installation 11 QC and Calibration Labels a Upon completion of the Service and the Operational Checklist and Performance Accept...

Страница 22: ...Perform the volume calibration using the test set up diagramed below Acceptance Criteria The pump must be within 5 to pass this test Required Equipment Scale with 0 01 gm degree accuracy BodyGuard tube set Collection vessel IV bag BodyGuard pole mount charger and power cord IV pole or similar mounting surface BodyGuard Pump ...

Страница 23: ...ing chamber once the pump has been inserted into the pole mount charger Load the pump into the pole mount charger and insert the pumping segment of the tube set into the pumping chamber 3 Power on the pump and set the BodyGuard 323 parameters in the following table using steps below a Press the INFO button until the option Change Setup appears Press the Start OK button b Using the down arrow zero ...

Страница 24: ...unt from the priming operation in Step 5 from the post delivery weight This number is the actual volume delivered The expected delivery is the volume programmed on the pump to be delivered Use the following equations to calculate the infusion rate error 8 If the results from step 7 is not within the 5 range the pump must be recalibrated Begin this process by entering the Technician Menu using the ...

Страница 25: ...ection value 5x 3 15 Current calibration values 535 Corrected calibration value 535 15 550 12 Repeat step 5 through step 10 until the pump is within the 5 specification criteria A result from the test in Step 5 that is within 5 for the pump meets the acceptance criteria Note Should you have any questions about the procedures described herein or any other BodyGuard product questions please contact ...

Страница 26: ...to display the pressure accurately anywhere within the operational range to the specification tolerance Perform the Occlusion Pressure Calibration using the test set up diagramed below Acceptance Criteria Alarm should occur at 10 4 2psi for BodyGuard 575 and 14 4 2 for the BodyGuard 323 545 Required Equipment Pressure Gauge 1 psi resolution BodyGuard tube set Collection vessel IV bag BodyGuard pol...

Страница 27: ...s not in place The voltage value in brackets should be less than 5V If this voltage is over 5V the pressure sensor may be faulty Replace sensor and recalibrate 4 The 2 1V is showing the status of the pressure Potentiometer 5 Load an unprimed BodyGuard tubing set into the pump Insert the key in the key recess and close the pump door The reading of the pressure sensor will change wait about 10 secon...

Страница 28: ...I and confirm with START OK key 12 The pump will use these values to automatically calculate the values required for pressure calibration 13 Release the built up pressure by disconnecting the set from the pressure gauge and reconnecting it 14 Enter Manual Calibration in Technician Mode change pressure cap option to 255 using the keypad 15 Test pressure alarm under normal operation Connect a pressu...

Страница 29: ...thout control or motor can t turn Electronic malfunction Replace Motor PCB ref sec 5 1 Wrong pressure calibration Repeat pressure calibration procedure if persists replace pressure sensor Error 7 Pressure sensor malfunction Replace pressure sensor and recalibrate ref sec 3 Error 10 Mechanical malfunction Turn the pump off and on again and set pump to operate on 0 1 ml hr Error 11 Mechanical malfun...

Страница 30: ... DC connector Error 25 Electronic malfunction Replace main PCB ref sec 5 1 Check for mechanical obstruction verify the motor is connected and verify the gear box has not separated from the motor Error 26 Mechanical obstruction motor connector not reconnected or gear box separation Motor Test Failed Motor PCB malfunction ref sec 5 1 Error 27 Electronic malfunction Replace main PCB ref sec 5 1 Encod...

Страница 31: ...t sensor Perform air sensor test If persists replace door air sensor If persists replace main PCB The door magnet has fallen out Install a door magnet ref sec 2 3 The door does not close properly Clear or adjust the door mechanism ref sec 2 4 Door open alarm The reed switch has malfunctioned Replace the Main PCB ref sec 5 1 The operation LED is turned off Change Set Up Enter Change Set Up and swit...

Страница 32: ... 1 The green battery LED does not illuminate while the pump is connected to charger AC connected within 2 to 4 hours after charging from Low Battery Check output of battery 5 8 4v Replace battery if required If persists replace charger PCB Date of Manufacturer is 0 S N is 0 Real Time Clock Battery power has been disconnected When the Real Time Clock battery has been disconnected or replaced all pr...

Страница 33: ...e version Customer request Program pump with requested software version ref sec 7 Programmable protocols are still programmed Software default setting have not been restored Restore software default settings ref sec 8 If after exhausting all diagnostic and service options the pump still does not operate correctly Unknown Return pump to customer with recommendation to remove from use ...

Страница 34: ... complete a service All fastening components such as screws washers and nuts used in the device are metric be sure to use metric tools and replace only with metric components Refer to Appendix A for pictures of disassembled pumps and chargers Caution The components inside the device are sensitive to electrostatic discharge ESD Always wear a grounded wrist strap and use a protective ESD mat when pe...

Страница 35: ...e holder on the charger PCB and using an ohmmeter check electrical continuity e If necessary replace with a new fuse of same value type and voltage F1 F2 20mm 800mA Slow Blow f Replace plastic fuse protection cover g Reassemble charger in reverse order 4 Perform Operational Checklist and Performance Acceptance Test 1 3 Checking Charger Voltage WARNING Voltage present on internal components may cau...

Страница 36: ...nable Pulse Oximeter feature through Change Set Up Menu 4 Note on service record if Pulse Oximeter feature was not enabled 5 If it was enabled attach working Pulse Oximeter to connector 6 Activate Pulse Oximeter by starting program 7 If it does not work replace Charger 8 Perform Operational Checklist and Performance Acceptance Test ...

Страница 37: ... compartment 2xM3 screws are located on the lower portion of the housing Remove the QC approval label to reveal these two screws 4 Separate the front and rear housing by holding the front housing firmly against the ESD mat and lifting the rear housing vertically away from the front housing Remove the screws from the rear housing and set them aside for later use 2 2 Reassemble the housing 1 Place t...

Страница 38: ...the hinge as shown on the diagram 2 Using a Phillips head screw driver remove the door mounted air sensor fixed with one M2 screw Pull the sensor out from its recess Door Air Sensor 2 5 mm security grub screws 3 Lift the air sensor cable and carefully using a 2 mm shaft push the hinge pin from the air sensor side left side and remove it from the pressure sensor side THE HINGE PIN WILL ONLY GO ONE ...

Страница 39: ...f the hinge pin support features on the chassis block hinge pin support features 8 Place the pressing plate into the recess in the door door recess 9 Lift the pressing plate and place the two door springs into their recesses in the door and pressing plate door springs 10 If you are fitting a new door or pressing plate ensure that Nylon bushings are present Place bushings into the hinge holes of th...

Страница 40: ...until a click is heard from the door catch 14 Verify the door releases when door latch is open Close the door Pull the door latch out about open and verify that the door opens If the door does not open at this point use a flat tip screw driver to adjust the latch mechanism by turning the screw as shown in the picture Repeat this adjustment until the door operates as specified 15 Perform Operationa...

Страница 41: ... fingers into slots in the pump block above cam Ensure beveled side of fingers face encoder plate Position of Pumping Fingers in Pumping Block 9 Replace the motor block assembly by turning the front housing assembly so that the key pad is facing up 10 Insert the new motor block assembly through the back side of the front housing so that the assembly is seated firmly against the inside of the front...

Страница 42: ...cement of Air Sensors 4 1 Front housing mounted air sensor 1 Separate the front and rear housing 2 Disconnect the front housing mounted air sensor at connector JP4 on main PCB Front housing mounted Air sensor connector JP4 3 The air sensor is glued to the front housing Using a screwdriver apply enough pressure to the ears on the back of the sensor to break them off and then push the sensor out of ...

Страница 43: ...o remove the connector pins from the air sensor connector Save this connector for later use 5 Replace the sensor with a new one 6 Insert the leads of the air sensor through the hole in the front housing 7 Insert the blue and white lead connector pins into the air sensor connector housing Insert pins into the connector housing so that when connected to the JP5 connector the blue wire is inserted in...

Страница 44: ...ws that hold the motor to the housing and remove motor 10 Install a new motor Refit the 2 screws using thread locking glue 11 Reassemble in reverse order 12 Perform Operational Checklist and Performance Acceptance Test 5 1 Replacement of PC Boards motor and main 1 Separate front and rear housings of the pump 2 Remove the pump door as described above 3 Remove pump assembly as described above 4 Care...

Страница 45: ...t the adhesive foam which holds the LCD to the main PCB 10 Gently lift on the LCD and use the sharp knife to score the adhesive foam After scoring the foam disconnect the LCD from the main PCB by pulling the collar out of the LCD connector 11 Remove all leftover adhesive foam 12 Install a new LCD by plugging it into the connector and engaging the collar 13 Place the LCD inside the white square tha...

Страница 46: ... the rear portion of the case onto the front portion of the case without disturbing the five pin wire connection 8 Open the Prog08sz software If the setup is connected properly the pump will begin to beep shortly after the programming software is opened 9 Select the button labeled Close COM Port 10 Set the correct port for the RS 232 cable by using to drop down menu labeled Port 11 Change the baud...

Страница 47: ...ustomer programmed setting must be reprogrammed prior to use 10 Perform Operational Checklist and Performance Acceptance Test BodyGuard Pump Software Default Settings BG 323 BG 545 BG 575 Settings Default Value Setting Default Value Setting Default Value Pressure default 14 psi Pulse Ox Enabled Pulse Ox Enabled Program Continuous Key stroke Volume Lowest setting Key stroke Volume Lowest setting Pr...

Страница 48: ...ing Always unplug the charger from AC power before cleaning Caution Do not clean the pump or charger with chemicals such as Xylene Acetone or similar solvents These chemicals can cause damage to plastic components Use a lint free cloth dampened with warm water and a mild detergent or disinfectant Caution Do not soak or immerse any part of the pump or charger in water Storage If the pump is to be s...

Страница 49: ...of 50 49 APPENDIX A Front Housing Rear View Rear Housing Rear View Main PCB Rear View Main PCB Front View with Display Motor PCB Rear View Motor PCB Front View ...

Страница 50: ...of 50 50 Display Rear View Display Front View Motor Block Motor Gear Encoder Cam Motor Block Assembly ...

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