IRadimed MRIDIUM 3860+ User Manual

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

IRadimed MRIDIUM 3860+ Specifications

General

Brand	IRadimed
Model	MRIDIUM 3860+
Category	Medical Equipment
Language	English

Summary

General Information

Indications for Use

Warnings and Precautions

General Warnings and Precautions

Covers safety instructions, MRI environment use, and patient care.

Pump Related Warnings/Precautions

Specific warnings and precautions related to the pump's operation.

Battery Pack Related Warnings/Precautions

Pulse Oximeter Related Warnings/Precautions

SECTION 1 INTRODUCTION

1.0 Introduction

1.1 Product Description

1.2 Controls

Explains how to operate the system using control keys.

1.2.1 Front Panel Control Keys

Details the function of each control key on the front panel.

1.3 Pump Preparation for Use

Describes various configurations for starting an infusion.

Primary Configuration

Dual Channel Infusion

Secondary Infusion (“piggyback”)

Bolus Delivery

Dose Rate Calculator

Calculating pump parameters for dose delivery.

Dose Rate Calculator with Drug Library

Using a drug library for dose rate calculations.

Dose Error Reduction System (DERS) Library (optional)

Using programmed infusion protocols with limits.

Administration Sets

1.4 Display

1.4.2 User message area

1.4.3 Infusion Parameter Setup Display

1.4.4 Secondary

1.4.5 Bolus

1.4.6 Special Features Setup Menu

Accesses features like Dose Rate Calculation and Alarm Volume.

1.5 User Interface

1.6 System Self Test

1.7 Maintenance and Operator Verification

1.8 Cleaning Instructions

SECTION 2 INSTALLATION

2.0 Installation

2.5 Preparing the Pump for Use

Steps to prepare the pump for operation.

Installing Battery

Installing Optional Pulse Oximeter Sensor

2.6 Mounting on I.V. Pole

2.7 Operational Checkout of the Pump

Verifying pump functionality after setup.

2.9 Remote Display Installation

Connecting and setting up the remote display.

SECTION 3 I.V. SET PREPARATION FOR USE

3.0 I.V. Set Preparation for Use

Precautions

3.2 I.V. Set Priming

Detailed procedures for priming various I.V. sets.

3.3 I.V. Set Insertion and Removal

Procedures for inserting and removing I.V. sets from the pump.

Administration Set Insertion

Administration Set Removal

SECTION 4 CONFIGURING THE PUMP FOR USE

4.0 Primary Configuration

Initial setup for infusions, including Rate and VTBI.

Programming a Basic Infusion

Entering flow rate and VTBI for a new infusion.

Editing the Infusion Program

Canceling/Pausing an Infusion

How to stop or pause an active infusion.

KVO (Keep Vein Open) - Infusion Complete

4.1 Dual Channel Infusion

Setting up simultaneous infusions on both channels.

Dual Channel Infusion Setup

4.2 Secondary (“Piggyback”) Infusion Configuration

Setting up sequential infusions on one channel.

Priming a Secondary Administration Set

Secondary Infusion Setup

Steps to set up a secondary infusion.

Programming a Secondary Infusion

Entering parameters for a secondary infusion.

Stopping a Secondary Infusion and Returning to Primary Infusion

4.3 Bolus Delivery

How to program and deliver bolus infusions.

Bolus Setup and Start

Steps to set up and initiate a bolus dose.

Stopping Bolus Rate Dose

4.4 Channel B

Attaching the Channel B SideCar

Detaching the Channel B SideCar

4.5 Special Features Menu

Accessing advanced features like Dose Rate Calculation.

4.5.1 Dose Rate Calculation

Calculating infusion rates based on dose parameters.

Basic Dose Rate Calculator

Dose Rate Calculator with Drug Library

Using the calculator with a pre-programmed drug library.

User Defined Drug Library settings (Internal Drug Library)

Setting up custom drug protocols.

4.5.2 Alarm Volume

4.5.3 KVO Rate

4.5.4 Occlusion Limits

Configuring pressure limits for occlusion detection.

4.5.7 Radio Channel menu

4.6 Air Bubble Detection and Reset

How the pump detects and responds to air bubbles.

SECTION 5 ALARMS

5.0 Alarms

Overview of alarm types and system responses.

5.2 User Messages

Responding to an Alarm

Steps to take when an alarm occurs.

SECTION 6 BATTERY OPERATION

6.0 Battery Operation

Overview of the smart battery pack and its monitoring.

6.2 Inserting the Battery Pack

Removing the Battery Pack

Testing the Battery Pack

6.6 Battery Charge Indicator

6.7 Battery Low Indication

6.9 Battery Care and Maintenance

1133 Battery Pack Maintenance Checkout Procedure

6.10 Battery Pack Replacement

6.11 Battery Pack Related Precautions

Specific safety precautions for the battery pack.

SECTION 7 PULSE OXIMETER

7.0 Introduction, Pulse Oximeter, 3860+

Overview of the integrated pulse oximeter.

7.0.1 User Warnings and Precautions

Critical safety warnings for pulse oximeter use.

7.1 Installation

7.2 Symbols, Displays, and Controls

Displays

7.3 Operator Verification

7.4 Operating the 3860+ Pulse Oximeter

Precautions for operating the pulse oximeter in an MR environment.

Probe Set-up and Use

Applying the Model 1170 Fiberoptic SpO2 Sensor

Step-by-step guide for applying the SpO2 sensor.

Verifying Operation of the Model 1170 Fiber Optic Sensor

7.6 SpO2 Alarms and Alerts

Information on SpO2 alarms and alerts.

Patient and Equipment-Related Alarms

Alarms requiring immediate patient attention.

Reviewing, Setting, or Changing Volumes and Alarm Limits

How to adjust alarm settings.

7.8 SpO2 Troubleshooting

Common SpO2 problems and their solutions.

SECTION 8 DOSE ERROR REDUCTION SYSTEM(DERS)

8.0 Dose Error Reduction System

Introduction to the DERS option.

8.1 Introduction

Overview of DERS features and benefits.

DERS Installation, Removal, Programming or Editing

Instructions for DERS installation and management.

8.3 DERS FEATURES AND DEFINITIONS

8.4 DERS RELATED ALERT AND USER PROMPT MESSAGES

Explains DERS alerts and prompts.

ALERT / PROMPT - MESSAGES, TYPE, CAUSE AND RESOLUTION

Detailed table of DERS messages and actions.

8.6 SETTING UP A DERS PRIMARY INFUSION

Step-by-step guide for setting up a primary infusion with DERS.

SETTING UP A DERS PRIMARY INFUSION

Detailed steps for primary DERS infusion setup.

Adjusting a Dose or the VTBI During an Infusion

How to adjust dose or VTBI during a DERS infusion.

SETTING UP A DERS BOLUS

Steps for setting up a bolus dose with DERS.

REPEATING A BOLUS DOSE

Canceling Bolus Delivery

DUAL CHANNEL DERS INFUSION

Setting up dual channel infusions with DERS.

DUAL CHANNEL BOLUS DELIVERY

Performing dual channel bolus delivery with DERS.

APPENDIX F TROUBLESHOOTING

Pump won’t turn on

Solutions for issues with the pump not powering on.

No Fluid Flow

Troubleshooting steps for lack of fluid flow.

Pump won't start

Solutions for the pump failing to start.

Fluid Leaking from Administration Set

Troubleshooting fluid leaks from the IV set.

Unit won't operate on battery

Solutions for the unit not working on battery power.

Battery operation is too short

Troubleshooting short battery life.

No audible alarm heard

Fluid delivery seems inaccurate

Addressing issues with inaccurate fluid delivery.

Keys won't function

Pump settings are restored to default

Infusion prematurely stopped

Identifying causes for premature infusion stoppage.

Unit alarms after each infusion start

Infusion stops

Troubleshooting causes for infusion stoppage.

Inlet Occlusion Alarm occurs when using 1057 Syringe IV Set

Recurring "Check Door" or "Close Door" messages occur when pump door is closed

APPENDIX G 1119 I.V. POLE ASSEMBLIES AND PARTS DESCRIPTIONS

IV POLE CONFIGURATION 1

3. Directions for Assembly (Refer to Assembly Diagram)

1119 Assembly Instruction Rev. C 010308

Installation Guide

General Precautions

Assembling the Roll Stand (Post to Base)

Attaching Upper IV Pole to Lower Pole

APPENDIX I 1145 Dose Error Reduction System

(DERS) Software Update Kit:

1145 Dose Error Reduction System (DERS) Software Update Kit: MRidium™ 3860+ IV Pump Software Update Procedure

Procedure to update the pump's software.

A. To determine the current IV Pump Software revision level:

B. To update the current IV Pump Software:

Steps to update the pump software.

C. To update the current IV Pump Software if using a Remote Display 3865:

Updating software with a remote display.

D. To add the DERS Library programming card:

Instructions for adding the DERS library card.