IRadimed MRidium 3850 User manual

38503850
SERVICE MANUALSERVICE MANUAL
REF 11REF 1125
MRidium MRI INFUSION SYSTEM
TM
REF 112

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: [phone] Fax: [phone]
e-mail:[email protected]
European Authorized Representative
7 Pinewood Drive
Ashley Heath, Market Drayton,
Shropshire, UK, TF9 4PA
www.medicaldeviceconsultancy.co.uk

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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 (3850 or 3851 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
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 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

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3.6.4 Verify Bubble Detect: ................................................................................ 3-31
3.7 Pump Calibration (3850/50R and 3851) ........................................................ 3-33
3.7.1 Factory Pump Calibration:.......................................................................... 3-33
3.7.2 Calibration Verification............................................................................... 3-36
3.7.3 Pump Accuracy Verification (3850/50R and 3851):........................................ 3-38
3.7.4 History Verification (3850/50R) .................................................................. 3-44
3.7.5 Radio Verification (3850R and 3855): ........................................................... 3-45
3.8 Power Supply verification (3855) ................................................................. 3-46
3.8.1 DC Input Verification (3855) ....................................................................... 3-46
3.8.2 Battery Charger Verification (3855)............................................................. 3-46
3.8.3 Line Power Verification Test (3855) ............................................................. 3-46
3.8.4 Initial Power-Up Verification (3855).............................................................. 3-47
3.8.5 Remote Pump Control Verification (3855).................................................... 3-48
3.8.6 Remaining Soft Key Verification .................................................................. 3-49
3.8.7 BATTERY CHARGE and Burn-In Verification (3855) ........................................ 3-49
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
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 Codes .................................................................................... 4-13
SECTION 5ASSEMBLIES AND SCHEMATICS..........................................................5-1

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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 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).

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12. Inspect AC Power/Charger Module and Power/Charger cable for physical
damage and/or missing parts (3850 only).
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.
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.
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.
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.

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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.

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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 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).