IRadimed MRIDIUM 3860+ User manual

3860+3860+
OPERATION MANUALOPERATION MANUAL
MRidium
MRI INFUSION/MONITOR SYSTEM
TM
REF 1138REF 1138
IRADIMEDIRADIMED
CORPORCORPORATIONTION

MRidiumTM 3860+ MRI Monitor/Infusion System
Operation Manual, Part Number 1138
Release 4B, 2015-10
PER ECN 000711
© 2010-2015 IRadimed Corporation
IRadimed Corporation
1025 Willa Springs Drive
Winter Springs, Florida 32708 U.S.A.
Tel [phone] Fax [phone]
www.iradimed.com
European Authorized Representative
Medical Device Consultancy
7 Pinewood Drive
Ashley Heath, Market Drayton,
Shropshire, UK, TF9 4PA
www.medicaldeviceconsultancy.co.uk

i
CONTENTS
Paragraph Page
General Information......................................................................... vi
Equipment Classification .................................................................. vi
Intended Uses / About the Pump .................................................... vii
Warnings / Precautions...................................................................viii
User Responsibility..........................................................................xiv
Definitions.......................................................................................xiv
Symbols .......................................................................................... xv
1.0 Introduction...................................................................................1-1
1.1 Product Description............................................................................1-1
1.1.1 Front of the Pump ....................................................................1-2
1.1.2 Pump Drive Mechanism .............................................................1-3
1.1.3 Back of the Pump .....................................................................1-4
1.1.4 1120 MRI Power Supply ............................................................1-5
1.1.5 Front of the Remote Display/Charger ..........................................1-6
1.1.6 Back of the Remote Display/Charger...........................................1-7
1.2 Controls...........................................................................................1-8
1.2.1 Front Panel Control Keys ...........................................................1-8
1.3 Pump Preparation for Use................................................................. 1-10
1.3.1 Administration Sets ................................................................ 1-11
1.3.2 Artifacts................................................................................1-11
1.4 Display ..........................................................................................1-13
1.4.1 Informational Display..............................................................1-17
1.4.2 User message area.................................................................1-17
1.4.3 Infusion Parameter Setup Display.............................................1-17
1.4.4 Secondary.............................................................................1-18
1.4.5 Bolus....................................................................................1-18
1.4.6 Special Features Setup Menu ...................................................1-19
1.5 User Interface.................................................................................1-19
1.6 System Self Test .............................................................................1-19
1.7 Maintenance and Operator Verification ...............................................1-19
1.8 Cleaning Instructions .......................................................................1-20
2.0 Installation.....................................................................................2-1
2.1 Introduction......................................................................................2-1
2.2 Unpacking the Pump..........................................................................2-1
2.3 Unpacking Remote Display/Charger .....................................................2-1
2.4 Unpacking 3861 Channel B SideCar .....................................................2-2
2.5 Preparing the Pump for Use ................................................................2-2
2.5.1 Installing Battery......................................................................2-2
2.5.2 Installing Optional Pulse Oximeter Sensor....................................2-2
2.5.3 Removing The Pulse Oximeter Sensor .........................................2-2
2.6 Mounting on I.V. Pole.........................................................................2-2
2.7 Operational Checkout of the Pump.......................................................2-2
2.7.1 Determining the current IV Pump Software revision level:..............2-3
2.8 Pump Storage...................................................................................2-3
2.9 Remote Display Installation ................................................................2-3
2.9.1 Charging Battery with the Remote. .............................................2-4
2.10 Language Options..............................................................................2-5
2.11 Product Structure ..............................................................................2-5

ii
3.0 I.V. Set Preparation for Use............................................................3-1
3.1 Precautions.......................................................................................3-1
3.2 I.V. Set Priming ................................................................................3-2
3.2.1 I.V. Administration Set 1056 Priming ..........................................3-2
3.2.2 I.V. ByPass Set 1055 Priming.....................................................3-2
3.2.3 I.V. Syringe Adapter Set 1057 Priming ........................................3-2
3.2.4 I.V. Extension Set 1058 Priming .................................................3-3
3.3 I.V. Set Insertion and Removal............................................................3-4
3.3.1 Administration Set Insertion ......................................................3-4
3.3.2 Administration Set Removal.......................................................3-4
4.0 Primary Configuration ....................................................................4-1
4.0.1 Programming a Basic Infusion....................................................4-1
4.0.2 Editing the Infusion Program......................................................4-2
4.0.3 Canceling/Pausing an Infusion....................................................4-2
4.0.4 KVO (Keep Vein Open) - Infusion Complete..................................4-3
4.0.5 Volume Infused........................................................................4-3
4.0.6 Pump Shut Down......................................................................4-3
4.0.7 Restoring an Infusion following Pump Power Down........................4-3
4.1 Dual Channel Infusion........................................................................4-4
4.1.1 Dual Channel Infusion Setup......................................................4-4
4.1.2 Single Channel/Dual Display Setup .............................................4-4
4.2 Secondary (“Piggyback”) Infusion Configuration ....................................4-5
4.2.1 Priming a Secondary Administration Set ......................................4-6
4.2.2 Secondary Infusion Setup..........................................................4-6
4.2.3 Programming a Secondary Infusion.............................................4-7
4.2.4 Viewing Primary Settings during a Secondary Infusion...................4-8
4.2.5 Changing Primary Settings during a Secondary Infusion.................4-8
4.2.6 Stopping a Secondary Infusion and Returning to Primary Infusion...4-8
4.2.7 Dual Channel Operation.............................................................4-8
4.3 Bolus Delivery...................................................................................4-9
4.3.1 Bolus Setup and Start ...............................................................4-9
4.3.2 Stopping Bolus Rate Dose........................................................4-10
4.3.3 Restoring Bolus Dose. ............................................................. 4-10
4.4 Channel B ......................................................................................4-11
4.4.1 Attaching the Channel B SideCar ..............................................4-11
4.4.2 Detaching the Channel B SideCar..............................................4-11
4.5 Special Features Menu .....................................................................4-12
4.5.1 Dose Rate Calculation .............................................................4-14
4.5.2 Alarm Volume........................................................................4-21
4.5.3 KVO Rate ..............................................................................4-22
4.5.4 Occlusion Limits .....................................................................4-23
4.5.5 Lock Keys..............................................................................4-24
4.5.6 NEXT MENU key .....................................................................4-24
4.5.7 Radio Channel menu...............................................................4-24
4.5.8 Exiting the Special Features Menu.............................................4-25
4.6 Air Bubble Detection and Reset. ........................................................4-25
4.7 Data Retention................................................................................4-25
5.0 Alarms............................................................................................5-1
5.1 Introduction......................................................................................5-1
5.2 User Messages..................................................................................5-1
5.3 Responding to an Alarm .....................................................................5-1
5.4 Remote Alarms .................................................................................5-2

iii
6.0 Battery Operation...........................................................................6-1
6.1 Introduction......................................................................................6-1
6.2 Inserting the Battery Pack ..................................................................6-1
6.3 Charging the Battery Pack ..................................................................6-1
6.4 Removing the Battery Pack.................................................................6-2
6.5 Testing the Battery Pack.....................................................................6-2
6.6 Battery Charge Indicator ....................................................................6-3
6.7 Battery Low Indication .......................................................................6-3
6.8 Battery Power Gauge .........................................................................6-4
6.9 Battery Care and Maintenance: ...........................................................6-4
6.9.1 Introduction.............................................................................6-4
6.9.2 1133 Battery Pack Maintenance Checkout Procedure .....................6-4
6.10 Battery Pack Replacement ..................................................................6-4
6.11 Battery Pack Related Precautions.........................................................6-5
7.0 Introduction, Pulse Oximeter, 3860+ .............................................7-1
7.0.1 User Warnings and Precautions ..................................................7-1
7.1 Installation.......................................................................................7-3
7.2 Symbols, Displays, and Controls..........................................................7-4
7.2.1 SpO2 Symbols .........................................................................7-4
7.2.2 Displays..................................................................................7-5
7.3 Operator Verification..........................................................................7-7
7.4 Operating the 3860+ Pulse Oximeter ...................................................7-7
7.4.1 Probe Set-up and Use ...............................................................7-8
7.4.2 Applying the Model 1170 Fiberoptic SpO2 Sensor..........................7-8
7.4.3 Verifying Operation of the Model 1170 Fiber Optic Sensor ............7-11
7.5 Probe Cleaning................................................................................7-11
7.5.1 Cleaning the Model 1170 Fiberoptic Sensor and 1171 Sensor Grips7-11
7.6 SpO2 Alarms and Alerts ...................................................................7-11
7.6.1 Patient and Equipment-Related Alarms......................................7-11
7.6.2 Watchdog Alarms ...................................................................7-11
7.6.3 Reviewing, Setting, or Changing Volumes and Alarm Limits..........7-12
7.7 SpO2 Menu Choices.........................................................................7-12
7.8 SpO2 Troubleshooting......................................................................7-13
7.9 SpO2 Parts and Accessories ..............................................................7-15
7.10 SpO2 Testing Summary....................................................................7-16
7.11 Specifications..................................................................................7-17
7.12 The Masimo Set® Principles of Operation............................................7-18
8.0 Dose Error Reduction System .........................................................8-1
8.1 Introduction: ....................................................................................8-1
8.2 DERS Installation ..............................................................................8-1
8.3 DERS FEATURES AND DEFINITIONS.....................................................8-2
8.4 DERS RELATED ALERT AND USER PROMPT MESSAGES ...........................8-3
8.4.1 ALERT / PROMPT - MESSAGES, TYPE, CAUSE AND RESOLUTION .....8-4
8.5 DERS Indicators / Status....................................................................8-6
8.6 SETTING UP A DERS PRIMARY INFUSION..............................................8-7
8.6.1 SETTING UP A DERS PRIMARY INFUSION.....................................8-7
8.6.2 Adjusting a Dose or the VTBI During an Infusion......................... 8-14
8.6.3 SETTING UP A DERS BOLUS.....................................................8-15
8.6.4 REPEATING A BOLUS DOSE .....................................................8-19
8.6.5 Canceling Bolus Delivery .........................................................8-20
8.6.6 DUAL CHANNEL DERS INFUSION ..............................................8-21
8.6.7 DUAL CHANNEL BOLUS DELIVERY.............................................8-23

iv
Specifications..........................................................................................A-1
Repair .....................................................................................................B-1
Warranty information..............................................................................C-1
Manufacturers Technical declaration ...................................................... D-1
IV Sets and Accessories...........................................................................E-1
Troubleshooting ......................................................................................F-1
1119 I.V. Pole Assemblies and Parts descriptions..................................G-13
Trumpet and start up curves................................................................... H-1
Appendix A: Specifications ......................................................................A-1
Appendix B: Repair..................................................................................B-1
Appendix C: Warranty information...........................................................C-1
Appendix D: Manufacturers Technical Declaration .................................. D-1
Appendix E: Accessories ..........................................................................E-1
Appendix F: Troubleshooting ...................................................................F-1
Appendix G: 1119 I.V. Pole Assemblies and Parts Descriptions............... G-1
Appendix H: Trumpet and start up curves............................................... H-1
Appendix I: 1145 Dose Error Reduction System....................................... I-1

v
FIGURES
Figure Page
1-1 Front of Pump...................................................................................1-2
1-2 Pump Drive Door Open.......................................................................1-3
1-3 Back of Pump....................................................................................1-4
1-4 Model 1120 MRI Power Supply ............................................................1-5
1-5 Front of 3865 Remote Display/Charger.................................................1-6
1-6 Back of 3865 Remote Display/Charger..................................................1-7
1-7 Front Panel Control Keys ....................................................................1-8
1-8 Setup Display Screens......................................................................1-13
1-9 Running Screens .............................................................................1-15
1-10 Special Features Setup Menu ............................................................ 1-18
3-1 Free Flow Preventer...........................................................................3-1
3-2 Roller and Slide Clamps......................................................................3-1
3-3 IV Set Installation .............................................................................3-5
4-1 Primary Pump Setup Screen................................................................4-1
4-2 Dual Infusion Display .........................................................................4-5
4-3 Secondary Infusion Set-up and Programming Screen .............................4-7
4-4 Bolus Setup Displays..........................................................................4-9
4-5 Attaching Channel B “SideCar” ..........................................................4-11
4-6 Special Features Menu .....................................................................4-12
4-7 Dose Rate Calculation Menu..............................................................4-14
4-8 Primary Screen with Dose Rate Displayed ........................................... 4-17
4-9 Alarm Volume Adjustment Screen......................................................4-21
4-10 KVO Rate Screen.............................................................................4-23
4-11 Set Comm Channel Displays .............................................................4-25
5-1 Alarm Display in User Message Area.....................................................5-2
6-1 Battery Installation............................................................................6-1
6-2 Battery Removal ...............................................................................6-2
6-3 Battery Test......................................................................................6-3
7-1 3860+ Display w/SpO2 ......................................................................7-4
7-2 Connecting the 1170 Fiberoptic Probe ..................................................7-9
7-3 Applying the 1170 SpO2 Sensor ........................................................7-10
7-4 Saturation Charting. ........................................................................ 7-19
Table Page
5-1 Alarm, Alert and User Prompt Messages ...............................................5-3
7-1 SpO2Alarm Limits.............................................................................7-8

vi
General Information
This document provides the following directions for use:
• Single channel pump that provides a full range of features in a compact,
easy to use, linear peristaltic pump.
• Dual channel pump offers the same features while providing two
independent infusion pumps in one instrument.
• The Remote Display/Charger Unit allows for remote ability to control the
Pump with a total of two channels from outside the MR Scanner.
The system is designed for use in the following patient care areas:
• MRI (0.2 to 3T systems).
• MRI/Recovery.
• Pump operable and safe in up to 1 Tesla (10,000 Gauss) magnetic field.
EMI Statement:
This equipment generates, uses and can radiate radio frequency energy and, if not
installed and used in accordance with the instructions, may cause harmful
interference to other devices in the vicinity. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause
harmful interference to other devices, which can be determined by turning the
equipment off and on, the user is encouraged to try to correct the interference by
one or more of the following measures: 1. Reorient or relocate the receiving device.
2. Increase the separation between the equipment. 3. Connect the equipment into
an outlet on a circuit different from that which the other devices(s) are connected. 4.
Consult the manufacture or field service technician for help.
Mains Disconnection Method:
3860 Pump: Disconnect power cord (1121) from Appliance Inlet on the side of the
MRI power supply unit (1120).
3865 Remote/Charger Unit: Disconnect power cord (1128) from Appliance Inlet on
the rear of the Unit.
Alternate Voltage/Export:
For power cord plug types see local country distributor. Unit shipped in USA with US
3 pin power NEMA plug.
3860 EQUIPMENT CLASSIFICATION
Classification according to IEC 60601-1
According to the type of protection
against electrical shock: Class I equipment and internally powered
According to the degree of protection
against electrical shock: Type CF (defibrillator-proof) equipment
According to the type of protection
against harmful ingress of water: Ordinary Equipment. Complies with Section 44.4 of the Infusion Pump standard, IEC 60601-2-24.
According to the methods of sterilization
or disinfection: Non-sterilizable. Use of liquid surface disinfects only.
According to the mode of operation Continuous operation
Equipment not suitable for use in the presence of flammable anesthetic mixture with air or
with oxygen or nitrous oxide