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MRidium

3860+ Infusion/Monitor System

Service Manual, Part Number 1125A

Release 6

2015-08

ECN 000

702

IRadimed Corporation

1025 Willa Springs Drive

Winter

Springs

, Florida 327

Tel: 407-677-8022 Fax: 407-677-5037

e-mail:[email protected]

European Authorized Representative

Medical Device Consultancy

7 Pinewood Drive

Ashley Heath, Market Drayton,

Shropshire, UK, TF9 4PA

www.medicaldeviceconsultancy.co.uk

IRADIMED
CORPORATION

Summary of Contents for MRidium 3860

Page 1: ...3860 3860 SERVICE MANUAL SERVICE MANUAL MRidium MRI INFUSION MONITOR SYSTEM TM REF 1125A REF 112 REF 1125A...

Page 2: ......

Page 3: ...n IRadimed Corporation 1025 Willa Springs Drive Winter Springs Florida 32708 Tel 407 677 8022 Fax 407 677 5037 e mail customerservice iradimed com European Authorized Representative Medical Device Con...

Page 4: ...1 4...

Page 5: ...ramming Adding Drug Names and Protocols 1 19 1 7 3 Create New Drug 1 20 1 7 4 Programming or Editing a Dose Protocol 1 21 1 7 5 Removing Drugs 1 22 1 7 6 Copy DERS Drug Library card cloning cards 1 22...

Page 6: ...3861 3 34 3 7 4 Verify Bubble Detect 3 34 3 8 Pump Calibration 3860 and 3861 3 36 3 8 1 Factory Pump Calibration 3 36 3 8 2 Calibration Verification 3 39 3 8 3 Pump Accuracy Verification 3860 and 386...

Page 7: ...iii 4 6 Flow Switch 4 12 4 7 Display Subsystem 4 12 4 8 Communications Interface and Signal Definitions 4 13 4 9 Critical Error Service Codes 4 13 SECTION 5 ASSEMBLIES AND SCHEMATICS 5 1...

Page 8: ...iv...

Page 9: ...s facility 1 Carefully remove the MRidium 3860 3861 or 3865 from their shipping containers It is recommended the shipping material be saved in the event an instrument has been damaged and must be retu...

Page 10: ...eakage Test Connect power cord 1121 to safety analyzer Connect ground cable from safety analyzer to the front chassis door latch clamp Perform an electrical leakage current measurement in compliance w...

Page 11: ...utest 2000 or equivalent 7 Pronk Technologies OxSim OX 1 SpO2 Finger Simulator or equivalent 1 4 1 Power Indicator Mount MRidium 3860 on IV pole With External DC Power Charger 1120 power cord 1121 to...

Page 12: ...nsert set spike into water container and hang water container approximately 21 inches above MRidium 3860 MRI Infusion Pump Squeeze drip chamber to fill approximately 2 3 full With Free Flow Restrictor...

Page 13: ...Allow Test to run for a minimum of 10 minutes and verify Ave is 100 00 ml 5 1 4 6 1 Alternate Flow Test Connect patient end of IV Set to a graduated 50 ml cylinder with 0 1 ml resolution Set Pump Rat...

Page 14: ...bar alarm LEDs flashes Clear occlusion remove hemostat then press the Start Stop Channel A Channel B for SideCar key and verify the pump begins running as indicated by the pulsing in the upper portion...

Page 15: ...y Note the COMM channel number can be seen adjacent to the radio antenna icon on the front LCD display Troubleshooting aids for radio communication in very RF tight MRI Magnet Rooms 1 Channel selectio...

Page 16: ...sent Custom Settings If you re program any previously programmed custom drug and or parameter setting the most recent settings will be retained as the Custom Drug Settings 7 This next choice is very i...

Page 17: ...during Normal Use mode If the SAME PATIENT is selected by the user the modified values are set in the Dose Rate Calculator If a NEW PATIENT is selected or the infusion pump has been turned off for mo...

Page 18: ...ted The choices for these values are mcg mg With Software version 3 0 xxxx and higher the expanded Drug Library choices for the 5 drug types and DERS Drug Library include the additional choices units...

Page 19: ...and select the next drug type drug modality and appropriate DOSE CONC and TIME if applicable and then again press SAVE DRUG Important During the drug programming always press the SAVE DRUG Softkey F6...

Page 20: ...TABLE is turned ON before any Custom Drug settings have been entered and saved all Drug types with the either the user preset factory default settings will be available in the Normal Use mode All num...

Page 21: ...until the messages BURNING CARD FLASHING MSTR FLASHED 1 2 3 is observed on the screen The F6 key can now be released The process will automatically complete and display FLASHING SUCCESSFUL 5 When FLAS...

Page 22: ...e VTBI 0 0 mL Same as Primary 0 0 mL Propofol Dose 0 0 mcg kg min Same as Primary 0 0 mg kg Conc 10 0 mg 1 ml Same as Primary 10 0 mg 1 ml Wt 0 0 kg Same as Primary 0 0 kg Rate UND mL hr Same as Prima...

Page 23: ...as Primary Rate Same as Primary Time Same as Primary VTBI Same as Primary MRidium Infusion Pump Serial Number ___________________________________________________ Note Retain a copy of this Worksheet w...

Page 24: ...TO 1400 mL hr in 1 mL hr increments 500 mL hr Bolus To Be Infused Range 0 1 to 999 mL 0 mL Occlusion Pressure Limit Range 1 to 10 PSI None always retains last setting Dose Programming Patient Weight...

Page 25: ...ntration mg 0 01 1 9 999 a mcg 0 01 None 9 999 a Units 1 1 25 000 b mU 1 None 25 000 b mL 1 1 999 a NOTES IMPORTANT When using DERS the actual use range will vary dependent on hospital set limits Cons...

Page 26: ...users Status indicators denoting when the Drug Library LIB is active and when infusion protocol parameters are operating outside designated soft limits These limits are programmed by the user as the s...

Page 27: ...omplete drug concentration information consisting of the units and dilution values of the concentration 1 7 1 Preparing the Pump and DERS memory for programming Enter SERVICE MODE Choose service mode...

Page 28: ...space for drug name characters Drug names must be no wider than this display screen Create drug names by choosing each letter number with the up down arrow keys Press ENTER to select a character and m...

Page 29: ...MIN limit as desired High and Low are soft limits which may be overridden by the user confirmation MAX and MIN are hard limits which cannot be exceeded 3 Set patient weight limits in a similar mannor...

Page 30: ...F6 will remove the highlighted drug name and protocol from the DERS memory card 1 7 6 Copy DERS Drug Library card cloning cards DERS memory card may be copied for use in multiple 3860 MR IV pump insta...

Page 31: ...rary programming card to be done by Biomed to be performed outside the MRI Magnet Room a Remove the small poly bag from the 1145 update kit which contains the Black Aluminum SD Card retainer clip and...

Page 32: ...y is 96 100 Pulse display is pulse rate of operator and no error messages are displayed Low Quality Noise ect are displayed on pumps LCD display See Figure 1 3 below Figure 1 3 d Remove sensor grip fr...

Page 33: ...l Leakage Test 1 3 2 1 Pass___Fail___ 4 Electrical Ground Test 1 3 2 2 Pass___Fail___ 5 Control and Indicator Operational Performance Test 1 4 Pass___Fail___ 6 Power Indicator 1 4 1 Pass___Fail___ 7 I...

Page 34: ...1 26...

Page 35: ...x available languages for the user interface presentations when available Put Pump into Service Mode by Press overlay KeyPad On I button and the holding the overlay KeyPad Cancel key depressed until t...

Page 36: ...pump to move to index beginning of pump cycle The top row of numerics at the bottom of the screen are defined as follows the first position displays motor speed in RPMs the second position is for dis...

Page 37: ...ill delete the current history record Note the history record can be downloaded to a PC using the History Log soft key F2 in the SERVICE MENU described below 3 Tare Offset Pressing this soft key F4 ju...

Page 38: ...o D count of 455 to 485 as displayed in the Service Mode in the left numerics beside P1 P2 2 1 2 Battery Status Screen The Battery Status is brought up by pressing the F2 soft key second key down on l...

Page 39: ...essible 2 1 3 1 Set Clock Pressing the Set Clock soft key F1 just to the right of the Set Clock option in the SERVICE MENU will select the Set Clock menu with Hour highlighted see Figure 2 5 Use the u...

Page 40: ...pump will start sent a text history log out the I O port Before selecting this menu option the pump must be connected to a PC with a standard RS232 cable no connection on pins 1 6 8 9 2 2 3 3 4 4 5 5...

Page 41: ...fer to Table 6 10 Infusion Rate mL hr P or PT mL hr S or ST mL hr K or KT mL hr B or BT Only when Primary P Secondary S KVO mode K or a Bolus B for channels A or B is started or after titration T is c...

Page 42: ...failure 79 Pressure Unstable 81 Program Lost re enter settings 83 Service mode activated Service screen has been entered 87 Dose rate program Weight 0 1 kg 999 9 kg kg When started from the DRC scree...

Page 43: ...running and has not seen a minor index mark Channel A 136 Slave processor did not see encoder index during normal operation Channel A 229 Slave processor did not see encoder index while seeking starti...

Page 44: ...warning at 5 capacity 2 Battery depleted alert Bad Battery running on battery power but unable to communicate with it 3 SpO2 Alert Low SpO2 4 SpO2 Alert Low HR 5 SpO2 Alert High HR 6 SpO2 Alert SpO2 I...

Page 45: ...ion of radio settings download the WIT2450 Integration Guide from www cirronet com 2 1 3 3 2 Command Use the Command soft key F1 to switch from command to setting then UP and Down arrow keys select co...

Page 46: ...lt setting of 63 mW 18 dBm and at this level will penetrate most MRI magnet screen rooms Some MRI magnet screen rooms are shielded tight enough to require the maximum power level setting of 250 mw 24...

Page 47: ...08 08 pk 00 d4 Set Minimum Data Length 01 01 pr 00 ff Set Packet Attempts Limit 08 08 pt 00 ff Set Data Transmit Delay 00 00 pv Set Slot Assignment 00 00 pw 00 2f Set Base Slot Size 08 08 px Set ARQ M...

Page 48: ...will change the display screen to the second Service Menu option page See Figue 2 9 Figure 2 8 2 1 3 7 Flow Switch On For MRidium 3860 Pump s Flow Switch On should be displayed as the first item on th...

Page 49: ...the Clear Custom Drugs softkey allows user to reset the Drug Table to the factory defaults see Section 1 6 for instructions on Clear Custom Drugs softkey 2 1 3 11 Previous Menu Pressing this soft key...

Page 50: ...2 16...

Page 51: ...gral microproces sor of the 3860 incorporates a diagnostic routine that monitors the instru ment s subsystems and operating parameters Detection of operating system irregularities or failures that aff...

Page 52: ...brush and or a cotton swab Once the contamination has been removed a cloth soaked with fresh water should be used to rinse the entire instrument removing and diluting all of the residual cleaning solu...

Page 53: ...is free of any corrosion or material that prevents free movement of the pumping chamber door 6 Check the door handle cam AS112 or AS113 to AS104 lock for ease of operation and flush fit with door when...

Page 54: ...Mode Verification Reference the Section 2 Service Mode description Service Mode is accessed by pressing the overlay KeyPad On I button and the holding the overlay KeyPad Cancel key depressed until the...

Page 55: ...P1 and P2 are now 5 0 5 3 2 4 2 4 Zero Verification after Adjustment Open pressure gauge hand bulb and verify P1 and P2 now read 0 0 2 Repeat Tare Offset and Pressure Adjust until P1 and P2 reads dis...

Page 56: ...at least 50 State of Charge xxx 50 to 100 Term Voltage V xx xxx 15 to 16 9 Cell 1x xxx 3 8 to 4 25 Cell 2x xxx 3 8 to 4 25 Cell 3x xxx 3 8 to 4 25 Cell 4x xxx 3 8 to 4 25 Note All cells should be wit...

Page 57: ...to enter Time and Date Press Menu Key to enter Time and Date changes or Cancel key to exit without changing settings Press Power Off 0 Key NOTE To save the new time or date the MENU key must be presse...

Page 58: ...tion Connect 106 db attenuator cable from Pump Antenna Connector to Test Remote Antenna Connector or install Antennas on both both Pump and Remote 3 2 4 11 1 Press Power I on Pump If New Patient and S...

Page 59: ...ed bar to the center of screen then press the ENTER key 3 2 4 11 3 5 On Pump press the F3 soft key to select Alarm Volume Verify Alarm Volume screen is displayed on Pump and Adjusting the Pumps Alarm...

Page 60: ...displayed With IV Set installed verify small b at bottom of screen Remove IV Set and verify large B at bottom of screen Press 0 Power Off key for 2 seconds to Power Off Pump Remove Battery then remove...

Page 61: ...ly 2 min then go to KVO Press Start Stop A on the Pump and verify average flow rate on infusion analyzer is 999 ml 5 or graduated beaker contains 33 3 ml 5 31 634 34 965 3 2 6 3 Set the Pump Rate to 5...

Page 62: ...hted With Down Arrow select 130 bpm and press Enter On both the Pump and Remote verify High HR displayed alternately with battery icon at top of screen Alarm sound and Alarm LED Reset HR Hi Limit to 2...

Page 63: ...sure pressure gauge remains at 5 0 press the F1 Key top left white key to enter the Calibrate Pump screen then press the F5 key Span Cal Press the Cancel key to return to the Service Mode display and...

Page 64: ...er bag Place output of IVP1056 infusion set into 100 ML empty graduated beaker or connect to Infusion Pump Analyzer Load Primed infusion set IVP1056 into Pump Run the pump at a high rate 1400 or 999 M...

Page 65: ...sing in the upper portion of the display and Green flashing LED in the top of the Door and rate is set to 25 mL hr Press Go in the Infusion Analyser or monitor graduated beaker The Pump will run for a...

Page 66: ...he displayed bar to move to the right of the screen Return displayed bar to the center of screen then press the ENTER key 3 2 10 3 5 On Pump press the F3 soft key to select Alarm Volume Verify Alarm V...

Page 67: ...ver power until placed into charge Over discharge can cause cells to outgas during subsequent charge cycles Severe outgassing can result in the battery pack swelling Replace any battery pack with visi...

Page 68: ...hysical Inspection of the Battery Pack case Remove the Battery Pack from the Pump or Remote Display and inspect for physical damage or signs of mechanical shock cracked casing or swollen case 3 2 11 1...

Page 69: ...nternal battery cells Any of these actions can cause the battery cells to heat smoke or cause catastrophic battery failure which could result in fire Do not attempt to disassemble the 1133 Battery Pac...

Page 70: ...om chassis with your left hand you will need to release the battery latch at the same time 3 2 12 4 Once a small gap is established and the battery has moved enough to release the latch and a larger g...

Page 71: ...3 21 Figure 3 2...

Page 72: ...X should appear momentarily before the main programming screen or Resume Therapy screen appears The software version is displayed in X X XXXX format e g Powering on 3 5 1 3 3 2 To update the current s...

Page 73: ...5 Software Update Verification NOTE As many software updates may provide new or enhanced features the operators MUST be made aware that software has been updated Always provide the operators such warn...

Page 74: ...anual REF 1138 3 5 2 Test Equipment Needed For complete detail system testing calibration 4 5 digit DMM BK model 1670A or equivalent Regulated DC Power Supply 20 V 3A 20 MHZ Dual Channel Oscilloscope...

Page 75: ...current draw from supply 0 030A 3 6 1 6 Press Power On I Key and from Normal Display adjust R103 Display Contrast on IVPAB002 for best viewing of display contrast 3 6 1 7 Verify Power Off requires 2 s...

Page 76: ...de description Put Pump into Service Mode by pressing Keypad On I button and holding the Keypad CANCEL key depressed until the Service Mode is displayed 3 6 4 1 Set R41 feedback fully CW R57 frequency...

Page 77: ...by pressing Keypad On I button and holding the Keypad CANCEL key depressed until the SERVICE MODE is displayed Verify Time and Date is saved correctly by pressing F3 soft key and then the F1 soft key...

Page 78: ...1x xxx 3 8 to 4 25 Cell 2x xxx 3 8 to 4 25 Cell 3x xxx 3 8 to 4 25 Cell 4x xxx 3 8 to 4 25 Note All cells should be within 2 of each other Current ma xxx 20 or greater cycle count x one or more S N V...

Page 79: ...in Section 5 Assemblies and Drawings 3 6 10 4 Green Run and Red Alarm LED Verification Load a fluid filled set into the pump and close the door Press Power On I key select New Patient and verify norma...

Page 80: ...on both Pump and Remote 3 6 10 9 3 On Remote press MENU key Press F1 soft key to select Dose Rate Calculation and verify Dose Rate A screen is displayed on both Pump and Remote Press CANCEL key 3 6 1...

Page 81: ...1 4 Using 10 key pad with VTBI highlighted enter 900 verify tone with each key press and then press C and verify VTBI displays 0 Enter 999 Using 10 key pad then press Enter 3 6 11 5 Using 10 key pad w...

Page 82: ...on Install Test 3861 Side Car on Pump if SideCar is to be used with pump Press Pump I key and verify Pump Power is On Resume Therapy screen appears press Same Patient Select Channel B and verify the f...

Page 83: ...d with small holes through the PCB cover to directly reach the trim pots below for easier motor adjustment WARNING When connecting and disconnecting the gray ribbon cable the IVPAB011 board all power...

Page 84: ...et to 20 press Start Stop A Adjust R57 drive pulse Channel 1 to 4 8ms Ensure that Channel 2 is measuring 2 pulses tics Monitor the lower left counter on the display displays encoder position from 0 to...

Page 85: ...ode display and verify P3 and P4 are now 5 0 5 3 7 4 1 4 Zero Verification after Adjustment Open pressure gauge hand bulb and verify P3 and P4 now read 0 0 2 Repeat Tare Offset and Pressure Adjust unt...

Page 86: ...ump calibration normally performed at the factory on both the 3860 and 3861 products It is highly recommended that should the 3860 pump or 3861 SideCar require this calibration that it be returned to...

Page 87: ...to 0 07 Verify Raw Curve will allow calibration Ideal Raw Curve is shown in Figure A If Curve shows too much taper see Figure B shims must be added to top pump standoffs Verify Raw Curve will allow c...

Page 88: ...3 38 Figure B Too Much Taper Raw Curve 3860 61 Figure C Not Enough Taper Raw Curve 3860 61...

Page 89: ...To Index Verify Comp is at 0 0 Press F2 soft key and verify Pump begins running Pump will now run for approximately 5 minutes When Pump stops Comp changes to a new value press CANCEL key and verify su...

Page 90: ...Scale window Select TStop on SartoConnect Using Microsoft Excel open the saved file and line graph data by highlighting the time and weight columns Verify step is less than 0 0075g for 3860 ref Figure...

Page 91: ...ter container and hang water container approximately 21 inches above MRidium 3860 MRI Infusion Pump Squeeze drip chamber to fill approximately 2 3 full With Free Flow Restrictor pinch clamp open prime...

Page 92: ...3 42 3 8 3 1 Infutest 2000 Connect patient end of IV Set to Infutest 2000 as shown below to either Channel A or B as desired and set the other channels stop cock to off as shown on following page...

Page 93: ...oximately 60 cc of water connect IV Set to right side as shown above the long 21 gauge flow restrictor side with stop cock position as shown run Pump for a short time to flush all air bubbles past sto...

Page 94: ...st Single Rate as shown below Rotate Flush syringe Stop to Prime Position and inject about 5 cc of water into the channel over about 5 seconds Note the Infutest reminds the user to do this via the LCD...

Page 95: ...3 45 Return the Stop Cock to the Test Position...

Page 96: ...L flow is within 2 set Pump to 10 mL and repeat flow test but allow Pump to run 10 minutes Again adjust Comp if necessary Verify 10 mL flow 2 Set Pump Rate to 1 mL and VTBI to 10 mL verify Ready to St...

Page 97: ...ick the Scale Menu icon button until the Trumpet is within the graph plot then select Print Verify Average Flow Rate is 1 mL 3 Verify the Max of the 2 Observation Period is less than 50 and Min of the...

Page 98: ...the Infutester Verify Average Flow Rate is 500 mL 3 and record 3 8 3 6 125 ml Flow Rate Test Select Cancel Infusion with the bottom function key on the Pump Set the Pump Rate to 125 mL hr VTBI 200mL...

Page 99: ...Verify Average Flow Rate is 0 4 mL 8 and record 3 8 4 History Verification 3860 Return to Service Mode by pressing the overlay KeyPad On I button and the holding the overlay KeyPad Cancel key depress...

Page 100: ...factory with a default setting of 63 mW 18 dBm and at this level will penetrate most MRI magnet screen rooms Some MRI magnet screen rooms are tight enough to require the maximum power level setting of...

Page 101: ...tion With Battery Simulator still connected and set to maximum charge current connect Autotransfor mer to the 3865 to be tested and set Autotransformer to 117 VAC nominal line voltages Power on Unit r...

Page 102: ...DETECTED UPDATING MSTR PROC VERIFYING ERASE ERASE OK FLASHED COUNTING TO 100 VERIFYING COUNTING TO 100 MSTR VERIFY OK FLASHING SUCCESSFUL 3 9 4 3 Verify No Communication Display follows Flashing Suc c...

Page 103: ...Alarm Silence key and verify the audio alarm sound is silenced 3 9 5 5 CANCEL Key Verification With Pump stopped and red bar alarm LED flashing press the CANCEL Key and verify Alarm LED stops flashing...

Page 104: ...15 to 16 8 Cell 1 x xxx 3 8 to 4 25 Cell 2 x xxx 3 8 to 4 25 Cell 3 x xxx 3 8 to 4 25 Cell 4 x xxx 3 8 to 4 25 Current ma xxx 20 or greater Note for later reference cycle count x 0 S N Verify serial n...

Page 105: ...s two processors with much of the safety and control based upon these processors watching the operation of the other 4 2 Mechanical Operation Though complete direct observation of the mechanical opera...

Page 106: ...4 2 Figure 4 1...

Page 107: ...ear peristaltic pumping mechanism assembly consists of three principle subassemblies shown in Figure 4 3 the non magnetic ultrasonic motor the camshaft pumping finger housing and the 1000ppr optical r...

Page 108: ...has two raised button areas which flatten the silicone section of 105x MR IV sets over the sensing face of each force sensor As pressure changes within the tubing the associated force change is transd...

Page 109: ...olume to be infused VTBI is a function of the total accumulated number ticks caused by motor run pulses from U6 And flow rate a function of the rate at which motor run pulses are issued The encoder wh...

Page 110: ...low of IV solution from the fluid source to the patient 4 3 Electronic Operation Electronic functionality and inter relationships are discussed below Utilize the block diagram of Figure 4 1 along with...

Page 111: ...initial average created just after door closure If this pressure drops beyond a preset amount the Inlet Occlusion alarm will be triggered Outlet pressure is compared to the Occlusion Pressure limit us...

Page 112: ...C suitable for charging up to 4 cells in series The battery also contains a gas gauge and charge monitor IC which limits the charge voltage and currents allowable into the battery pack Smart circuits...

Page 113: ...e setting of R57 The outputs on pins 15 18 of U2 pass to special high speed FET gate drivers U5 and U6 These drivers provide a very fast level shifted drive into the power FET s Q1 4 for high efficien...

Page 114: ...SPI I2C internal and external U8 UARTs A D U5 and LCD display Once these basic hardware units are initialized the main software process begins Keypad is continually scanned under 60 Hz interrupt drive...

Page 115: ...shape filtering and power amplifying clocking signals from either the eZ80 U3 or U6 These tone clock signals are summed at R37 U10 is a digital pot controlled by U6 This 50K digital pot has 32 taps se...

Page 116: ...down if detected during pumping The sense of an open condition advances the mechanism to its programmed starting point and conducts a test of the motor and encoder system as well as pressure sensor a...

Page 117: ...CTS DTR Data Terminal Ready Not Connected 9 NOTE Maximum leakage current to chassis ground from connected peripheral equipment must not exceed 400uA Alarm Code Action Description Details of Descriptio...

Page 118: ...dex mark while the motor is not running and has not seen a minor index mark Channel B 236 23 Pump Malfunction Slave processor did not see encoder index during normal operation Channel B 1000 23 Pump M...

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