MRidium 3850 Service Manual section 1 to 4 Rel 6A July 2013

MRidiumTM 3850 Infusion System Service Manual, Part Number 1125 Release 6A, 07/2013 ECN 000490

© 2005-2013 IRadimed Corporation IRadimed Corporation 7457 Aloma Ave, Suite 201 Winter Park, Florida 32792 Tel: 407-677-8022 Fax: 407-677-5037 e-mail:[email protected]

European Authorized Representative 7 Pinewood Drive Ashley Heath, Market Drayton, Shropshire, UK, TF9 4PA www.medicaldeviceconsultancy.co.uk

TABLE OF CONTENTS Paragraph

Page

1.0 1.1 1.2 1.3 1.3.1 1.3.2 1.4 1.4.1 1.4.2 1.4.3 1.4.4 1.4.5 1.4.6 1.4.7 1.4.8 1.4.9

PREPARATION FOR USE... 1-1 Introduction ... 1-1 Pre-Operational Mechanical Inspection... 1-1 Operational Performance Check ... 1-2 Pre-operational Check Battery Charge ... 1-2 Pre-operational Electrical Inspection ... 1-2 Control and Indicator Operational Performance Test ... 1-3 Power Indicator ... 1-3 Initialization ... 1-3 Alarm Sound ... 1-4 Prepare IV Set... 1-4 Install 1056 IV Set... 1-4 Flow Test (3850 or 3851 SideCar) ... 1-5 Inlet Occlusion Test... 1-6 Patient Occlusion Test ... 1-6 Bubble detected (Air In Line) Test ... 1-6

2.0 2.1 2.1.1 2.1.2 2.1.3

SERVICE MODE DESCRIPTION ... 2-1 Service Mode Display ... 2-1 Calibrate Pump Screen ... 2-3 Battery Status Screen. ... 2-4 Service Menu Screen ... 2-5

3.0 PREVENTIVE MAINTENANCE... 3-1 3.1 Introduction ... 3-1 3.2 Preventive Maintenance ... 3-1 3.2.1 Cleaning Instructions... 3-2 3.2.2 Mechanical Inspection ... 3-2 3.2.3 Basic Tools ( For basic repairs and PM’s) ... 3-4 3.2.4 3850/50R PM Service Mode Verification ... 3-4 3.2.5 3850/50R Pump Flow Test ... 3-10 3.2.6 3851 PM Service Mode Verification ... 3-11 3.2.7 3851 Pump Flow Test: ... 3-13 3.2.8 3855 PM Verification ... 3-14 3.2.9 Battery Pack Maintenance ... 3-16 3.2.10 Removing a swelled Battery Pack (Figure 3-2) ... 3-18 3.3 Software Update... 3-20 3.4 Systems Test ... 3-22 3.4.1 Reference Documents... 3-22 3.4.2 Test Equipment Needed ... 3-22 3.4.3 Basic Tools ... 3-22 3.5 MRidium MR IV Pump, main unit, Verification (3850/50R) ... 3-23 3.5.1 DC Input Verification ... 3-23 3.5.2 Battery Input Verification. ... 3-23 3.5.3 Battery Charge Verification & Adjustment... 3-24 3.5.4 Pump Motor Speed Adjustment... 3-24 3.5.5 Time and Date Verification ... 3-25 3.5.6 3850/50R Pressure Verification ... 3-25 3.5.7 Battery Verification : ... 3-26 3.5.8 Bubble Detect Verification :... 3-26 3.5.9 Verify No Bubble Detect :... 3-26 3.5.10 3850R/3855 Remote Radio Setup ... 3-27 3.6 MRidium Side Car Verification (3851) ... 3-29 3.6.1 DC Input Verification (3851) ... 3-30 3.6.2 Pump Motor Speed Adjustment (3851) ... 3-30 3.6.3 Service Mode Display Verification (3851) ... 3-31

i

3.6.4 3.7 3.7.1 3.7.2 3.7.3 3.7.4 3.7.5 3.8 3.8.1 3.8.2 3.8.3 3.8.4 3.8.5 3.8.6 3.8.7

Verify Bubble Detect: ... 3-31 Pump Calibration (3850/50R and 3851) ... 3-33 Factory Pump Calibration: ... 3-33 Calibration Verification... 3-36 Pump Accuracy Verification (3850/50R and 3851): ... 3-38 History Verification (3850/50R) ... 3-44 Radio Verification (3850R and 3855): ... 3-45 Power Supply verification (3855) ... 3-46 DC Input Verification (3855) ... 3-46 Battery Charger Verification (3855) ... 3-46 Line Power Verification Test (3855) ... 3-46 Initial Power-Up Verification (3855)... 3-47 Remote Pump Control Verification (3855)... 3-48 Remaining Soft Key Verification ... 3-49 BATTERY CHARGE and Burn-In Verification (3855) ... 3-49

4.0 4.1 4.2 4.2.1 4.2.2 4.2.3 4.2.4 4.3 4.3.1 4.3.2 4.3.3 4.4 4.5 4.6 4.7 4.8 4.9

PRINCIPLES OF OPERATION... 4-1 Introduction ... 4-1 Mechanical Operation ... 4-1 Physical Description ... 4-1 Pumping Mechanism... 4-3 Force sensors (Pressure Transducer) ... 4-4 Mechanical Functional Operation ... 4-5 Electronic Operation ... 4-6 Electronics Functional Description ... 4-6 Power Supply / Motor Driver Functional Operation ... 4-7 Processor Assembly ... 4-9 Air-In-Line Detector ... 4-11 Door Sensor... 4-12 Flow Switch... 4-12 Display Subsystem... 4-12 Communications Interface and Signal Definitions ... 4-13 Critical Error Codes ... 4-13

SECTION 5ASSEMBLIES AND SCHEMATICS ... 5-1

ii

SECTION 1 PREPARATION FOR USE 1.0 PREPARATION FOR USE 1.1

Introduction This section contains information relative to the initial inspection and preoperational checkout of the MRidium 3850 Infusion Pump/Controller, the 3851 SideCar Secondary Pump and 3855 Remote Display/Charger. These procedures include a mechanical inspection, electrical inspection, pre-operational battery charge and a performance check to ensure that the instruments operate properly and have not been damaged during shipment or storage. The MRidium 3850's operating features are identified in the MRidium 3850 Operation Manual (IRadimed PN 1124).

1.2

Pre-Operational Mechanical Inspection The MRidium 3850 and it’s accessories have undergone thorough production control and quality assurance testing prior to shipment from Iradimed. The shipping container has been designed to protect the instruments against damage under normal shipping conditions; nevertheless, internal physical and/or electronic component damage could have occurred without leaving a visible signature. Therefore, it is recommended that the following inspection procedure be performed upon receipt of the instruments at the user's facility. 1. Carefully remove the MRidium 3850, 3851 or 3855 from their shipping containers. (It is recommended the shipping material be saved in the event an instrument has been damaged and must be returned to the factory for service or repair). 2. Inspect the exterior cases, front and rear, for holes, cracks, scratches, broken or damaged controls, missing components and/or screws. 3. Inspect the display window covering and overlay for scratches or cracks (3850 or 3855). 4. Ensure the pumping chamber access door fits flush with the case at the top, bottom, and sides (3850 or 3851). 5. Check the door handle/cam lock for ease of operation and flush fit with door when latched (3850 or 3851). 6. Inspect the pumping mechanism seal for damage and to ensure they are properly attached to the front case (3850 or 3851). 7. Inspect the Bubble detector and Flo-Stop recess for damage or obstructions (3850 or 3851). 8. Install an approved Iradimed administration set to ensure the Flo-Stop assembly seats correctly and the door closes and latches properly (3850 or 3851). 9. Actuate each of the keypad controls on the front panel and ensure proper operation (see Section 1 of 1124 Operation Manual for location of controls) (3850 or 3855). 10. Exercise the pole clamp mechanism to ensure freedom of movement (3850 only). 11. Inspect the power cord for damage, bent prongs or deformed connector (3850 or 3855).

1-1

12. Inspect AC Power/Charger Module and Power/Charger cable for physical damage and/or missing parts (3850 only). NOTE In the event a MRidium 3850, 3851 or 3855 shows evidence of shipping damage, notify the carrier's agent immediately. Do not return a damaged instrument to the factory before the carrier’s agent has authorized repairs. Contact IRadimed for authorization to return the instrument for repair regardless of liability for repair costs. 1.3

Operational Performance Check Prior to the first operational use and following any routine maintenance or servicing of the MRidium 3850 and it’s accessories, it is strongly recommended that an operational performance check be performed. The operational performance check consists of two phases; a Pre-operational Electrical Inspection to check the electrical integrity of the instrument for compliance with regulatory agency requirements and an Operational Performance Test to verify proper pump operation. 1.3.1 Pre-operational Check Battery Charge Connect External DC Power/Charger (1120) power cord (1121) to AC Outlet, connect DC Charger cable from External DC Power/Charger (1120) to 3850 pump DC input insuring connectors at both ends are screwed in tightly and allow the battery to charge for 6 hours. 1.3.2 Pre-operational Electrical Inspection The pre-operational electrical inspection includes an electrical leakage test and a ground continuity check.

CAUTION Some of these tests are inherently hazardous. Safeguards for personnel and property should be employed when conducting such tests. Tests should only be performed by qualified personnel. 1.3.2.1 Electrical Leakage 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 with Underwriters Laboratories (UL) 2601 for Patient Care Equipment and / or IEC-60601-1. Leakage currents are to be less than 300 microamperes. 1.3.2.2 Electrical Ground Test Connect External DC Power/Charger (1120) power cord (1121) to 25 Amp Ground tester, connect DC Charger cable from External DC Power/Charger (1120) to 3850 pump DC input insuring connectors at both ends are screwed in tightly. Open pump door and connect alligator clip of chassis Ground wire from Ground tester to front chassis door latch pin and verify less than 0.1 ohms ground resistance and no fail test status.

1-2

1.4

Control and Indicator Operational Performance Test The following operational performance test is designed to ensure each of the MRidium 3850's controls and indicators is functioning properly, and to check the operability of all the features available in the normal operating modes. These tests and associated procedures are presented in a sequence that provides an efficient, qualitative check of instrument operability. Test Requirements The following items of laboratory equipment and supplies are required to conduct the operational performance tests: 1. IRadimed 1056 administration set. 2. IV Solution Container. 3. Standard IV Pole. 4. Hemostat. 5. Empty fluid container. 6. Infutest 2000 (or equivalent) 1.4.1 Power Indicator Mount MRidium 3850 on IV pole With External DC Power/Charger (1120) power cord (1121) to line power, DC Charger cable connected from External DC Power/Charger (1120) to 3850 pump DC input remove 1133 Battery Pack from Pump and verify LED below power on/ off switches is illuminated Green. Reinstall 1133 Battery Pack and verify LED below power on/off switches is illuminated Yellow or Amber. 1.4.2 Initialization Power on using overlay (IVP-0010) On (I) button. Verify the following initial display with current Software revision: IRI LOADER FLASHER © 2005 MS03 ”Day””Month””YR” HR:Min:Sec MS01 ”Day””Month””YR” HR:Min:Sec NO CARD DETECTED followed by: Powering On $REV: XXX$ (XXX = Current software revision) followed by: Normal pump display (Figure 1-1). Verify display is clear and readable.

1-3

Figure 1-1. 1.4.3 Alarm Sound Momentarily press the Off switch and verify Alarm sound. Pump should not turn off. Verify Power Off requires 2 second depression of the O (off) key. 1.4.4 Prepare IV Set Using IV Set 1056 insert set spike into water container and hang water container approximately 21 inches above MRidium 3850 MRI Infusion Pump. Squeeze drip chamber to fill approximately 2/3 full. With Free Flow Restrictor pinch clamp open prime tubing and clear air by slowly open roller clamp allowing water to fill tubing. 1.4.5 Install 1056 IV Set Install 1056 IV Set in 3850 Pump or 3851 SideCar as shown and close door (See Figure 1-2).

1-4

Figure 1-2. 1.4.6 Flow Test (3850 or 3851 SideCar) Connect patient end of IV Set to Infutest 2000 (or other IV Pump Flow test device). Set Pump Rate to 100 ml and VTBI to 25 ml, verify Ready to Start is flashing in lower right of the display. 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 of the display and Green flashing LED in the top of the door. 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 Rate to 100 ml and VTBI to 25 ml, verify Ready to Start is flashing in lower right of the display. 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 of the display and Green flashing LED in the top of the door. Press the Start/Stop Channel A (Channel B for SideCar) key when the pump completes the 25 ml and verify graduated cylinder contains 25 ml +/- 1.25 ml.

1-5

1.4.7 Inlet Occlusion Test 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 of the display and Green flashing LED in the top of the door. Use the hemostat to pinch off the tubing above the instrument and verify the following conditions: 1. Pump stops. 2. INLET OCCLUDED” Flashes in the upper portion of the screen. 3. Alarm audio – sounds. 4. Red bar alarm LEDs flashes. 1.4.8 Patient Occlusion Test 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 of the display and Green flashing LED in the top of the door. Use the hemostat to close off the distal tubing and verify the following conditions 1. Pump stops. 2. “PATIENT OCCLUDED” Flashes in the upper portion of the screen. 3. Alarm audio – sounds. 4. Red 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 of the display and Green flashing LED in the top of the door 1.4.9 Bubble Detected (Air In Line) Test Set Pump Rate to 500 ml and VTBI to 100 ml, verify Ready to Start is flashing in lower right of the display. 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 of the display and Green flashing LED in the top of the door. Tilt Drip Chamber below spike and allow a 0.75 (approximately 100 microliter) to 2 inch air bubble to enter line. Wait for air bubble to pass through pump and verify the following conditions: 1. Pump stops. 2. “Bubble Detected” Flashes in the upper portion of the screen. 3. Alarm audio – sounds. 4. Red bar alarm LEDs flashes.

NOTE The Bubble Detector is located at the bottom of the pump and requires minimum of 100 microliter bubble to be detected. Repeat test if bubble brakes up before reaching Bubble Detector.

1-6

1.5

Radio Option Setup and Verification.

See Section 1.1.3 and 1.1.6. of the 1124 MRidiumTM 3850 Operation Manual. Connect 2.4 GHz antenna and AC Power Cord to Remote Display Charger. Verify MRidiumTM 3850 MRI IV Pump has Remote Radio Option installed. And perform the following: a. b. c.

Turn both Pump and 3855 Remote Display/Charger on. Press the Menu key on the Remote Display/Charger Press the NEXT MENU soft key to bring up additional menu options, then press the Set Comm Channel soft key. From the Radio Channel menu, select the desired Channel 1 through 6 by pressing the soft key next to that channel and verify that Channel is now highlighted.

d.

e.

Press the Menu key on the MRidiumTM 3850 MRI IV Pump.

f.

Press the NEXT MENU soft key to bring up additional menu options, then press the Set Comm Channel soft key. From the Radio Channel menu, select the same Channel that was selected for the Remote by pressing the soft key next to that channel and verify that Channel is now highlighted. Add an ID marker on both the Remote and Pump with the Channel selected. Verify communication between Remote and Pump by pressing the Menu key on one and the Cancel key on the other, and observing both display match and change simultaneously.

g. h. i.

WARNING: Never Set two Pumps or Remotes on the same Comm Channel. Always confirm the remote display is communicating with the selected before use. Note: In software version 582 or later, the COMM channel number can be seen adjacent to the radio antenna icon on the display. Troubleshooting aids for radio communication in very RF-tight MRI Magnet Rooms: 1) Channel selection - each of the 6 channels actually modify several communications parameters which provide a very wide range of RF link diversity. Please try different channels to find the best link. 2) Location - the 3855 Remote unit must be located close to the wall/window into the MR scanner room. It is recommended to be less than 3 feet away from the window. Do not allow people to get between the remote and pump, humans absorb large amounts of the 2.4 GHz frequency power of the link. 3) Adjust Radio Transmission power - IN the Service Mode, the radio power can be adjusted from medium power (+18 dBm is the standard factory setting) to high power (+24 dBm). 4) External Antenna - You can add an external antenna with longer cable which can be fixed directly on the viewing window. This can increase communication reliability in most all cases.

1-7

MRidium 3850 PREPARATION FOR USE TEST DATA SHEET

Pump Serial No. _______________ Software Revision ______________________

Date ________________

Technician ____________________________________

Description

Test No.

Reference Paragraph

Pass/Fail

1

Pre-Operation Mechanical Inspection

1.2

Pass___Fail___

2

Battery Charge

1.3.1

Pass___Fail___

3

Electrical 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

Initialization

1.4.2

Pass___Fail___

8

Power Key Alarm Sound

1.4.3

Pass___Fail___

9

Flow Test

1.4.6

Pass___Fail___

10

Inlet Occluded

1.4.7

Pass___Fail___

11

Patient Occluded

1.4.8

Pass___Fail___

12

Bubble Detected (Air-In-Line)

1.4.9

Pass___Fail___

13

Remote Radio Verification

1.5

Pass___Fail___

SECTION 2 SERVICE MODE DESCRIPTION 2.0 SERVICE MODE DESCRIPTION The MRidium 3850 is configured with a Service Mode that allows technicians to access the software diagnostic subsystem. Once the Service Mode is enabled, the technician can use the diagnostic test sequences to verify operation of the operator interface features, to operate the pumping mechanisms independent of the alarm/malfunction interrupts, to check Analog to Digital voltages and to access the history log. Additionally, the Service Mode is used to test the serial port, configure the instrument's radio communication interface and select one of the six 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 the Service Mode is displayed. Once enabled, Maintenance Mode operation is strictly software dependent. The Channel B Start/Stop key changes the pump from SERVICE MODE A (main 3850 pump) to SERVICE MODE B (3851 SideCar pump). 2.1

Service Mode Display

Figure 2-1. The initial Service Mode A screen (see Figure 2-1) displays current time, P1 pressure sensor located directly above the pump mechanism for inlet pressure/occlusion sensing for pump channel A, and P2 located below the pump mechanism for patient side fluid pressure sensing of pump channel A, if

2-1

the side-car is installed P3 pressure sensor located directly above the pump mechanism for inlet pressure/occlusion sensing for pump channel B, and P4 located below the pump mechanism for patient side fluid pressure sensing of pump channel B; Sensor A to D count is displayed on the left with pressure in psi displayed on the right of each location. These are non-selectable information displays. Selections from the Service Mode screen are Rate, Calibrate Pump, Manual Pump Run, and Move to Index. The initial selection is Rate, from this selection the Up and Down keys are used to change the Rate, Enter key is used to set the selected Rate, and Start/Stop Channel A key. “Calibrate Pump” is used for initial pump calibration and requires a Sartorius GD603 scale connected to the pumps I/O port, and is used to find the pumps index offset point (typically for factory use only). “Manual Pump Run” when selected and the enter key is pressed commands the pump to run at a constant speed and is used for motor tuning. “Move to index” when selected and the Enter key is pressed, commands the 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 display of the scale weight value when connected to the Sartorius GD603 scale, and the third position is for display of the various completion and error codes when using the Sartorius GD603 scale for calibration. The fourth position shows the motor counter timer, which decrements from 1000 to 0 as the motor rotates. When the motor is stopped, the counter timer is set to 240 (as shown). Whenever the motor is started, or the flow rate is changed, the counter timer is rest to 1000. The bottom row of alpha-numerics are defined as follows: ??? - On initial enter to the to the Service Mode screen this area will display ???, once the pump has been commanded to move it will display the current position of the encoder wheel. B - “B” equals bubble detected or air in line at bubble detector, “b” equals no bubble detected. P - “P” equals Line power is detected, “p” equals no line power detected. 7 - This numeric is currently for factory use only. 1113 - This numeric is a display of the regulated 11V power supply, (1113 = 11.13V).

2-2

2.1.1 Calibrate Pump Screen

Figure 2-2. From the Service Mode screen the Calibrate Pump A or B Screen (see Figure 2-2) is accessed by pressing the F1 (top function key on the left side of the display screen). This screen is for displaying current pump A or SideCar B calibration settings, adjusting these settings, clearing the History record and making pressure sensor adjustments. NOTE The Delay setting should be recorded for future reference should a repair action cause loss of this Delay setting. This Delay setting is found during factory calibration with the pump connected to a high accuracy calibrated scale (Sartorius GD603) while the delivery profile at 1 ml/Hr is studied by internal calibration software. Anytime the mechanical alignment of the encoder wheel relative to the pumping finger position is changed or suspect ( pump block or motor replaced ), this calibration process must be performed. 1. Delay and Comp. Use the enter key to move from Delay and Comp and the up or down arrows followed by the Enter key to change these settings (see above NOTE). The Comp is adjustable from +8.0% to -8.0% and is used to adjust pump flow accuracy. 2. Clear History. Pressing this soft key (F3) just to the right of the Clear History option will 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) just to the right of the Tare Offset option will Zero the pressure sensors. Note: These sensors must be zeroed with IV set tubing in place without fluid (or fluid level at center of pump).

2-3

4. Span Cal. Pressing this soft key (F5) just to the right of the Span Cal option will set the Span of the pressure sensors. The software assumes 5 psi is applied to the pressure sensors. Note: To ensure pressure has been applied the software looks for an A to 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 left side of screen) from the SERVICE MODE screen.

Figure 2-3. 2.1.2.1 Battery Status The Battery Status screen (see Figure 2-3) displays the State of Charge, Terminal Voltage, each of the 4 Cell voltages, current in milliamps, cycle count, and battery serial number.

2-4

2.1.3 Service Menu Screen

Figure 2-4. The SERVICE MENU (see Figure 2-4) is brought up by pressing the F3 soft key (third key down on left side of screen). From this menu the Set Time, History Log, Radio Settings, Keylock, Language and a Next Menu are accessible. 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 up and down arrow keys to change the hour, then press Enter key to set the Hour and move to minute selection. Repeat this process for each selection. The soft key (F2 & F3) may be used to access Time or Date directly. Press the CANCEL key to exit this menu.

2-5

Figure 2-5. 2.1.3.2 History Log. Pressing the History Log soft key (F2) just to the right of the History Log in the SERVICE MENU will select the History Log (see Figure 2-6) for output to the rear I/O port. The screen will display Press ENTER to stop and the 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 & 7-7) and a terminal program running ready to receive. Set your terminal program as follows: Baud rate: 1200. Data: 7 bit. Parity: none. Stop: 1 bit. Flow Control: none. NOTE We use “Tera Term Pro” available free on the internet.

2-6

The following table describes this history log output. Token

Description

Format

Event

1

Power On

SW Revision string

3

KVO Rate changed

#.# mL / hr

4

Occlusion Pressure Alarm Limit (downstream) changed

# PSI

5

Alarm Volume Limit changed

# (no units)

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 confirmed

11

Volume to be infused

#.# mL, P or PT #.# mL, S or ST #.# mL, K or KT #.# mL, B or BT

Only when Primary, Secondary, KVO mode or a Bolus for channels A or B is started or after titration is confirmed

12

Volume infused

#.# mL, P #.# mL, S #.# mL, K #.# mL, B #.# mL

Only when Primary, Secondary, KVO mode or a Bolus for channels A or B is started, after titration is confirmed, or the VI is cleared.

14

Stop infusion button pressed

#.# mL

Store VI

2-7

At power up

Token

Description

Format

Event

15

Cancel infusion button pressed

#.# mL

Store VI

17

Alert Detected

Alert number. See table 4

18

Hold time exceeded alarm

22

Pump door open has just been opened

23

Pump Malfunction

Error number See error number Table 2.

29

Time or date was changed

Time when set time screen was exited

39

History data corrupted

40

On Battery, or on AC Power

Switch to AC power or Start/Switch on Battery power.

49

Audible alarm silenced

Alarm Code See Table 3.

50

Alarm Detected

Alarm Code. See Table 3.

67

Power Off -with power switch

68

Power Off - without power switch (AC power or Battery failure)

83

Service mode activated

87

Dose rate program – Weight (0.1 kg – 999.9 kg)

#.# kg

When started from the DRC screen.

88

Dose rate program – Dose (0.001 – 999.900)

0.001 mcg/kg/min, or 0.001 mg/kg/min, or 0.001 mg/kg/hr

When started from the DRC screen. Store the appropriate units with the dose value.

89

Dose rate program – Concentration (0 – 99.990)

0.001 mg

When started from the DRC screen.

90

Dose rate program – Dilute (1- 999)

1 mL

When started from the DRC screen.

91

Dose rate program – Rate

0.1 ml/hr

When started from the DRC screen.

92

Dose rate program – VTBI

0.1 ml

When started from the DRC screen.

93

Dose rate program – Drug

Drug index. See table 5.

When started from the DRC screen.

95

Recheck Settings

0 = Primary 1 = Secondary 2 = Bolus

100

History Checksum Error

At power up when a checksum error has been encountered.

101

History database has been cleared.

When history log is manually cleared.

102

Remote Comm. Established

103

Remote Comm. Lost

AC = AC Power B = Battery Power

Service screen has been entered