IRadimed MRidium 3860 User manual

38603860
SERVICE MANUALSERVICE MANUAL
MRidium
MRI INFUSION/MONITOR SYSTEM
TM
REF. 1125A
REF 112
REF 1125A

MRidiumTM 3860+ Infusion/Monitor System
Service Manual, Part Number 1125A
Release 6B, 2015-08
ECN 000702
©2009-2015IRadimed Corporation
IRadimed Corporation
1025 Willa Springs Drive
Winter Springs, Florida 32708
Tel: [phone] Fax: [phone]
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

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TABLE OF CONTENTS
Paragraph Page
1.0 PREPARATION FOR USE ................................................................. 1-1
1.1 Introduction......................................................................................1-1
1.2 Pre-Operational Mechanical Inspection .................................................1-1
1.3 Operational Performance Check...........................................................1-2
1.3.1 Pre-operational Check Battery Charge ..................................................1-2
1.3.2 Pre-operational Electrical Inspection.....................................................1-2
1.4 Control and Indicator Operational Performance Test ...............................1-3
1.4.1 Power Indicator.................................................................................1-3
1.4.2 Initialization......................................................................................1-3
1.4.3 Alarm Sound.....................................................................................1-4
1.4.4 Prepare IV Set ..................................................................................1-4
1.4.5 Install 1056 IV Set ............................................................................1-4
1.4.6 Flow Test (3860+ or 3861 SideCar) .....................................................1-5
1.4.7 Inlet Occlusion Test ...........................................................................1-6
1.4.8 Patient Occlusion Test ........................................................................1-6
1.4.9 Bubble detected (Air In Line) Test........................................................1-6
1.5 Radio Setup and Verification ...............................................................1-7
1.6 Programming Custom Drug Settings ....................................................1-8
1.7 MRidium™ 3860+ MR IV Pump.......................................................... 1-18
1.7.1 Preparing the Pump and DERS memory for programming...................... 1-19
1.7.2 Programming / 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
1.7.7 Erasing DERS Memory Cards............................................................. 1-23
1.8 Pulse Oximeter Verification (3860+ only)............................................ 1-24
2.0 SERVICE MODE DESCRIPTION........................................................ 2-1
2.1 Service Mode Display .........................................................................2-1
2.1.1 Calibrate Pump Screen .......................................................................2-3
2.1.2 Battery Status Screen. .......................................................................2-4
2.1.3 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 3860+ PM Service Mode Verification ...................................................3-4
3.2.5 10 Key Pad Verification (3860 only) ................................................... 3-10
3.2.6 Pump Flow Test............................................................................... 3-11
3.2.7 SpO2 Verification............................................................................ 3-12
3.2.8 3861 PM Service Mode Verification................................................... 3-12
3.2.9 3861 Pump Flow Test:..................................................................... 3-14
3.2.10 3865 PM Verification ...................................................................... 3-15
3.2.11 Battery Pack Maintenance............................................................... 3-17
3.2.12 Removing a swelled Battery Pack (Figure 3-2) ................................... 3-20

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3.3 Software Update ............................................................................. 3-22
3.4 Dose Error Reduction System (DERS) Option Installation ...................... 3-23
3.5 Systems Test .................................................................................. 3-24
3.5.1 Reference Documents ...................................................................... 3-24
3.5.2 Test Equipment Needed.................................................................... 3-24
3.5.3 Basic Tools .................................................................................... 3-24
3.6 MRidium MR IV Pump, main unit, Verification (3860+) ......................... 3-25
3.6.1 DC Input Verification........................................................................ 3-25
3.6.2 Battery Input Verification................................................................. 3-25
3.6.3 Battery Charge Verification & Adjustment ........................................... 3-26
3.6.4 Pump Motor Speed Adjustment ......................................................... 3-26
3.6.5 Time and Date Verification................................................................ 3-27
3.6.6 3860+3860+ Pressure Verification..................................................... 3-27
3.6.7 Battery Verification :........................................................................ 3-28
3.6.8 Bubble Detect Verification : .............................................................. 3-28
3.6.9 Verify No Bubble Detect : ................................................................. 3-28
3.6.10 3860+ Remote Radio Setup ............................................................ 3-29
3.6.11 10 Key Pad Verification (3860+ only) ............................................... 3-31
3.6.12 SpO2 Verification (3860+ Only)....................................................... 3-31
3.7 MRidium Side Car Verification (3861) ................................................. 3-32
3.7.1 DC Input Verification (3861) ............................................................. 3-33
3.7.2 Pump Motor Speed Adjustment (3861) ............................................... 3-34
3.7.3 Service Mode Display Verification (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 3861): ................................... 3-41
3.8.4 History Verification (3860+)............................................................. 3-49
3.8.5 Radio Verification (3860+ and 3865): ................................................ 3-49
3.9 Power Supply verification (3865) ....................................................... 3-50
3.9.1 DC Input Verification (3865) ............................................................. 3-50
3.9.2 Battery Charger Verification (3865)................................................... 3-51
3.9.3 Line Power Verification Test (3865)................................................... 3-51
3.9.4 Initial Power-Up Verification (3865) ................................................... 3-51
3.9.5 Remote Pump Control Verification (3865) ......................................... 3-53
3.9.6 Remaining Soft Key Verification ........................................................ 3-53
3.9.7 BATTERY CHARGE and Burn-In Verification (3865) .............................. 3-54
4.0 PRINCIPLES OF OPERATION .......................................................... 4-1
4.1 Introduction.....................................................................................4-1
4.2 Mechanical Operation ........................................................................4-1
4.2.1 Physical Description ...........................................................................4-1
4.2.2 Pumping Mechanism .........................................................................4-3
4.2.3 Force sensors (Pressure Transducer) ...................................................4-4
4.2.4 Mechanical Functional Operation.........................................................4-5
4.3 Electronic Operation..........................................................................4-6
4.3.1 Electronics Functional Description .......................................................4-6
4.3.2 Power Supply / Motor Driver Functional Operation.................................4-7
4.3.3 Processor Assembly ..........................................................................4-9
4.4 Air-In-Line Detector ......................................................................... 4-11
4.5 Door Sensor .................................................................................. 4-12

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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

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1-1
SECTION 1
PREPARATION FOR USE
1.0 PREPARATION FOR USE
1.1 Introduction
This section contains information relative to the initial inspection and pre-
operational checkout of the MRidium 3860+ Infusion Pump/Controller, the 3861
SideCar Secondary Pump and 3865 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
3860's operating features are identified in the MRidium 3860+ Operation
Manual (IRadimed PN 1138).
1.2 Pre-Operational Mechanical Inspection
The MRidium 3860+ 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 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 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
(3860+ or 3865).
4. Ensure the pumping chamber access door fits flush with the case at the top,
bottom, and sides (3860+ or 3861).
5. Check the Door Handle/Eazy Latch lock for ease of operation and flush fit
with door when latched (3860+ or 3861).
6. Inspect the pumping mechanism seal for damage and to ensure they are
properly attached to the front case (3860+ or 3861).
7. Inspect the Bubble detector and Flo-Stop recess for damage or
obstructions (3860+ or 3861).
8. Install an approved Iradimed administration set to ensure the Flo-Stop
assembly seats correctly and the door closes and latches properly (3860+
or 3861).
9. Actuate each of the keypad controls on the front panel and ensure proper
operation (see Section 1 of 1138 Operation Manual for location of controls)
(3860+ or 3865).
10. Exercise the pole clamp mechanism to ensure freedom of movement
(3860+ only).
11. Inspect the power cord for damage, bent prongs or deformed connector
(3860+ or 3865).

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12. Inspect AC Power/Charger Module and Power/Charger cable for physical
damage and/or missing parts (3860+ only).
1.3 Operational Performance Check
Prior to the first operational use and following any routine maintenance or
servicing of the MRidium 3860+ 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 3860+ pump DC input insuring connectors at both ends are
screwed in tightly and allow the battery to charge for at least 6 hours.
1.3.2 Pre-operational Electrical Inspection
The pre-operational electrical inspection includes an electrical leakage
test and a ground continuity check.
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 3860+ 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.
NOTE
In the event a MRidium 3860+, 3861 or 3865 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.
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
1.4 Control and Indicator Operational Performance Test
The following operational performance test is designed to ensure each of the
MRidium 3860+'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)
7. Pronk Technologies OxSim, OX-1 SpO2Finger Simulator (or equivalent).
1.4.1 Power Indicator
Mount MRidium 3860+ 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 3860 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
© 201X
MS03 ”Day””Month””YR” HR:Min:Sec
MS01 ”Day””Month””YR” HR:Min:Sec
NO CARD DETECTED
followed by:
Powering On
X.X.XXXX
(X.X.XXXX = Current software revision)
followed by:
Normal pump display (Figure 1-1). Verify display is clear and readable.

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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 3860 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 3860+ Pump or 3861 SideCar as shown and close
door (See Figure 1-2).

1-5
Figure 1-2.
1.4.6 Flow Test (3860+ or 3861 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.

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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.

1-7
1.5 Radio Setup and Verification
See Section 1.1.3 and 1.1.6. of the 1138 MRidiumTM 3860+ Operation Manual.
Connect 2.4 GHz antenna and AC Power Cord to Remote Display Charger.
a. Turn both Pump and 3865 Remote Display/Charger on.
b. Press the Menu key on the Remote Display/Charger
c. Press the NEXT MENU soft key to bring up additional menu options,
then press the Set Comm Channel soft key.
d. 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.
e. Press the Menu key on the MRidiumTM 3860+ MRI IV Pump.
f. Press the NEXT MENU soft key to bring up additional menu options,
then press the Set Comm Channel soft key.
g. 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.
h. Add an ID marker on both the Remote and Pump with the Channel
selected.
i. 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.
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 selection - each of the 6 channels actually modify several commu-
nications parameters which provide a very wide range of RF link diversity.
Please try different channels to find the best link.
2) Location - the 3865 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 set-
ting) 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 commu-
nication reliability in most all cases.
5) Space between Emitters - Make sure there is at least 0.5meters (20
inches) between the IRadimed equipment Antenna and any other radio emit-
ters (e.g. monitors, injectors, etc.).
WARNING: Never Set two Pumps or Remotes on the same Comm Channel.
Always confirm the remote display is communicating with the selected before use.

1-8
1.6 Programming Custom Drug Settings
1. Enter Service Mode. This is done by pressing the Power On (1) button
while simultaneously holding the CANCEL key until the Service Mode MENU
is observed on the screen.
2. Select the NEXT MENU Softkey 3 (F3), which will enter the extended MENU
3 choices.
3. On this MENU 3a, select Softkey 6 which will enter the next level of
extended MENU 3b choices.
4. On this sub-MENU 3b you should see the following:
• Flow Switch On (or Off)
• Drug Table On (or Off)
• Edit Custom Drugs
• Clear Custom Drugs
• <none>
• Previous Menu
5. Verify that the Drug Table is enabled (ON). If it is not on, press Softkey 2
(F2) to turn on the Drug Table. Now all drug name choices will be
available for programming.
6. When starting new, always select "Clear Customs Drugs" before beginning,
which will ensure that the Drug Table has been reset to the factory default
values. The factory default values can be seen in Table 1.
Important: Do not select "Clear Custom Drugs" if any additions have
been previously made to the Custom Drug Table, and you wish to retain
these earlier settings. Selecting the new drug and/or parameter settings
will add these values to your present 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 important. The 3860 System allows the user to set
the initial default drug that is presented in the Dose Rate Calculator (First
Drug). By simply selecting and saving a drug name with its new user
preset infusion parameters immediately after "Clear Custom Drugs", this
first drug choice will be the initial drug seen when accessing the Dose Rate
Calculator.
8. Select the EDIT CUSTOM DRUGS Softkey 3 (F3) on MENU 3b. This will
present the standard Dose Rate Calculator Set-up screen. Select the First
Drug choice by using the UP or DOWN keys to scroll through the 5 drug
options (i.e. Drug?, Adenosine, Dobutamine, Propofol, or
Dexmedetomidine). When the appropriate drug is seen, press the ENTER
key to set the drug name.
9. Once the drug name has been selected, now select the drug modality to be
programmed (i.e. Primary, or Bolus) by pressing the ENTER key.
Important: The Secondary modality is provided in these options, but is
not able to be programmed independently from the Primary settings. In
the Normal Use mode, all Secondary infusions will use the either the
factory default or the user-preset values from the Primary infusion
parameters for the specific drug type.

1-9
10. Once the drug modality has been selected, now the DOSE, CONC
(Concentration), or TIME (if applicable) values can be programmed. This
can be accomplished by either using the ENTER key to scroll to the
appropriate selection, or by pressing the appropriate Softkeys (either F1,
F2, or F5) to select the DOSE, CONC, or TIME settings. The possible range
of settings for each of these values can be found in the enclosed Table 3.
11. Set the DOSE numeric value using the UP/DOWN keys, or the numeric
keypad keys. The numeric keypad keys include a decimal point, as well as
a "Clear the number" function (the "C" key). Press ENTER once the
numeric value has been selected.
Important: Once these DOSE numeric values are set by the user, they
become the initial staring points for a NEW PATIENT infusion in the Dose
Rate Calculator. These numeric values can be modified 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 more than 1 hour, the user-preset
DOSE numeric values become the initial staring points for a NEW PATIENT
infusion in the Dose Rate Calculator.
12. Set the DOSE units value using the UP/DOWN keys. Press ENTER once the
numeric value has been selected. The choices for these values are:
• mcg/kg/min
• mg/kg/min
• mcg/kg/hr
• mg/kg/hr
• mcg/kg
• mg/kg
• mcg/min
• mg/min
• mcg/hr
• mg/hr
Important: Once the DOSE unit values are set by the user, they can't be
modified during Normal Use mode, as they will remain fixed to the user-
preset values. The only way to modify these DOSE units will be to re-enter
the Service Mode and re-program these units.
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:
• mg
•mcg
• mU/kg/min*
• Units/kg/hr*
• mU/kg/hr*
• Units/min*
• Units/hr*
• mU/hr*
• mU/min*

1-10
• Units*
• mU*
• Units/kg*
• mU/kg*
*With Software version 3.2.9 and higher, when selecting the units-based
Dose Units values, the Concentration Units Value must first to set to either
"units", or "mU".
With Software version 3.2.9 and higher, the default Bolus Dose units for
the Drug Library choices for the 5 drug types, and DERS Drug Library
includes the following choice:
• mL (NOTE: The "mL" selection is available as a Dose unit choice.
Additionally, the Bolus Dose feature now includes the Factory Default
to be "0 mL" with a Time of "1 Minute" for the 5 drug types).
13. Now select the CONC (Concentration) numeric numerator values by either
using the ENTER key to scroll to the CONC selection, or by pressing the
appropriate Softkey (F2) to select the CONC setting. Set the CONC
numeric value using the UP/DOWN keys, or the numeric keypad keys. The
numeric keypad keys include a decimal point, as well as a "Clear the
number" function (the "C" key). Press ENTER once the numeric value has
been selected.
14. Set the CONC numerator units value using the UP/DOWN keys. Press
ENTER once the numeric value has been selected. 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
• mU (milli-units)
With Software version 3.2.9 and higher, when selecting the units-based
Dose Units values, the Concentration Units Value must first to set to
either "units", or "mU".
15. Now select the CONC (Concentration) numeric denominator value by
either using the ENTER or F2 key to scroll to the CONC selection. Set the
CONC numeric value using the UP/DOWN keys, or the numeric keypad
keys. The numeric keypad keys include a decimal point, as well as a "Clear
the number" function (the "C" key). Press ENTER once the numeric value
has been selected.
Important: Once these CONC numeric values are set by the user, they
become the initial staring points for all infusions for this drug type in the
Dose Rate Calculator. These numeric values can be modified 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 more than 1 hour,
the user-preset CONC numeric values become the initial staring points for
a NEW PATIENT infusion in the Dose Rate Calculator.

1-11
NOTE: The CONC denominator units value is always in milliliters (mL) and can't be
modified.
16. If any timeless DOSE units have been set (e.g. mcg/kg or mg/kg), the
TIME value can be set using the UP/DOWN keys, or the numeric keypad
keys. The numeric keypad keys include a "Clear the number" function (the
"C" key). Press ENTER once the numeric value has been selected.
17. Save all the user-preset value by pressing the SAVE DRUG Softkey (F6).
The set up screen will now return to MENU 3a. Select.
Important: During the drug programming, entries can be made into the
WEIGHT, RATE, AND VTBI areas, but these values are not saved as user-
presets. They are only made available to allow the user to check the entry
values are within the acceptable limits of the various parameters. In
Normal Use mode, these values will reset to zero (0) until set by the user
prior to the infusion.
18. The set up screen will now return to MENU 3a. Select the NEXT MENU
Softkey (F6) to access the Custom Drug set-up choices.
19. On this sub-MENU 3b you should see the following:
• Flow Switch On (or Off)
• Drug Table On (or Off)
• Edit Custom Drugs
• Clear Custom Drugs
• <none>
• Previous Menu
20. Repeat the programming process, beginning at Step 8 above, 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) after each group of user-preset values have been entered
(e.g. first group - Adenosine/Primary, second group -Adenosine/Bolus,
third group -Dobutamine/Primary, fourth group - Dobutamine/Bolus, etc.).
If SAVE DRUG is not pressed, the user-preset values will not be retained,
and either the prior settings, or factory default settings will be used for this
drug type in the Dose Rate Calculator.
21. Complete the programming process cycling through Steps 8 through 17
above until all user-reset values have been saved. For the user's
convenience, a table for retaining the user-presets number in enclosed in
Table 2, and can be photocopied for multiple uses to record each
MRidium's Pumps user settings.
Note: If the DRUG? Drug type is programmed by the user for a custom drug not
listed in the MRidium Pump's default drug name list (e.g. adrenaline), then these
custom settings are saved, the DRUG? Label in the Dose Rate Calculator will be
changed to CUSTOM to denote another drug type has been entered. Record this
custom drug name in Table 2, and it is recommended to add a label to the MRidium
pump identifying this custom drug type for all operator's to see before initiating an
infusion using these parameters.

1-12
22. If only 1 or 2 drug types are programmed by the user, the remaining drug
types will continue to show the factory default values in the Normal Use
mode of the Dose Rate Calculator. These default values can be found in
enclosed Table 1.
23. After all the user-presets have been entered and saved, the Pump can be
shut off by pressing the Power Off (0) key.
24. Turn on the Pump by pressing the Power On (1) button. Access the Dose
Rate Calculator as described in the Operator's Manual, and now confirm
the user-preset values have been correctly entered. It is recommended to
set-up a test IV set and initiate a brief (1 to 10 second duration) infusion
for each user-preset drug type and modality to confirm proper operation
before returning the pump to clinical use.
25. If any problems occur during the programming of the user-preset values,
or the user-preset values need to be canceled or erased, the CLEAR
CUSTOM DRUGS softkey can be pressed at any time to reset all Dose rate
Calculator back to the factory default values found in Table 1.
26. Another feature available in the Service Mode Dose Rate Calculator set-up
is the additional options available with the use of the DRUG TABLE OFF
choice. There are four optional modes of operation:
•One, if the DRUG TABLE is turned OFF before any Custom Drug
settings have been entered and saved, only the DRUG? Drug type
with the factory default settings will be available in the Normal Use
mode. All numeric and units values can be modified when used in
this manner.
•Two, if the DRUG 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 numeric values can be modified when used in
this manner, but the units values for any user-preset values can't be
modified when used in this manner (as described above in Step 12).
•Three, if the DRUG TABLE is turned ON, programmed by the user, and
then turned off after the Custom Drug settings have been entered
and saved, only the First-Drug Drug type with the user-preset values
will be available in the Normal Use mode. All numeric values for this
single drug type can be modified when used in this manner, but the
units values for any user-preset values can't be modified when used
in this manner (as described above in Step 12).
•Four, if the DRUG TABLE is turned OFF after the CLEAR CUSTOM
DRUGS key has been pressed, only the DRUG? Drug type with the
factory default settings will be available in the Normal Use mode. All
numeric and units values can be modified when used in this manner.
27. If any user-preset values are modified, or new drug types or modalities
are added to the original programmed set of parameters, always record
the updated user-presets values and added drug types or modalities in a
new copy of Table 2 for the MRidium Pump's user settings. Again, it is
recommended to set-up a test IV set and initiate a brief (1 to 10 second
duration) infusion for each user-preset drug type and modality to confirm
proper operation before returning the pump to clinical use.
28. As an added feature, the customized user-preset values can be duplicated
and transferred to other pump(s). To do this, perform the following steps: