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.