Medrad Intego User Manual

3031103 Rev. G
Operation Manual

Medrad Intego Specifications

General

Brand	Medrad
Model	Intego
Category	Medical Equipment
Language	English

Summary

1 - Introduction

Certifications and Regulatory Information

System certifications, intended use, indications, and sale restrictions.

Contact Information

MEDRAD and support contact details.

Symbols and Icons

Explains symbols used in the manual and on equipment.

Warnings and Cautions

Explains warning and caution symbols and their meanings.

Display and Status Indicators

Overview of system interface icons and status lights.

2 - System Basics

System Overview and Clinical Needs

Describes the system's purpose and how it meets clinical requirements.

Safety Features

Details the safety mechanisms integrated into the system.

System Components

Lists and describes the main components of the system.

Shielded Chamber Components

Details specific parts within the shielded chamber.

SAS Components

Identifies and describes components of the Source Administration Set.

PAS Components

Identifies and describes components of the Patient Administration Set.

Vial Shield and Calibration Source Holder

Describes vial shield and calibration source holder components.

Managing Power States

Procedures for powering the system on, off, and into standby.

Securing the System

Instructions for locking the device and shielded chamber.

Navigating the User Interface

Overview of system screens and navigation elements.

Moving the System

3 - System Configuration

System Settings

Configuration options for language, date, time, units, and audio.

Dosing Settings

Configuration of default dose, personalized dosing, and formulas.

Maintenance Settings

Configuration for Daily QC, Linearity, Calibration, and Service.

Security Settings

Settings for device lock and managing security codes.

4 - Daily Setup

Placing the System into Clinical Mode

Steps to switch the system from training to clinical operation.

Using the Schedule

Procedures for entering or importing infusion schedules.

Performing Daily QC

Step-by-step guide for daily quality control checks.

Entering RP Assay and Saline Information

Procedure for inputting radiopharmaceutical and saline data.

Installing the SAS

Instructions for installing the Source Administration Set.

Installing the Multi-Dose Vial

Steps for installing the multi-dose vial into the system.

Installing the PAS

Instructions for installing the Patient Administration Set.

Priming the SAS

Procedure to prime the SAS with saline and RP.

5 - Patient Infusion

Entering Patient Information

Procedure for inputting patient and operator details.

Priming the PAS

Steps to prime the Patient Administration Set.

Selecting the Flow Rate

How to set and confirm the infusion flow rate.

Performing a Saline Test Inject

Procedure for performing an optional saline test injection.

Dose Activity Entry

Personalized formula-based and manual methods for entering dose activity.

Requested Activity and Activity Bar

Understanding the displayed requested activity and activity bar.

Preparing an RP Dose

Steps to prepare the radiopharmaceutical dose for infusion.

Infusing or Discarding the Dose

Steps for starting, monitoring, completing, or discarding an infusion.

Monitoring the Vial

System alerts for insufficient vial activity or volume.

6 - Vial Shield and SAS Removal

Vial Shield and SAS Removal Procedures

Detailed steps for safely removing the SAS and vial shield.

7 - Training Mode

Training Mode Operation

Guidelines and limitations for using the system in training mode.

Appendix A - Cleaning and Maintenance

Cleaning Guidelines

Instructions for cleaning system components with safe solutions.

Recommended Maintenance Schedule

Routine maintenance tasks and frequency recommendations.

Dose Calibrator Linearity Check

Procedure to check dose calibrator linearity.

Calibrating the Pinch Valves

Steps to calibrate the pinch valves.

Battery Maintenance and System Storage

Guidelines for battery care and system storage.

Appendix B - Specifications

Mechanical Specifications

Physical dimensions and weight of the system.

Radiation Shielding Profile

Details on radiation exposure rates and reduction.

Environmental and Electrical Specifications

Operating environment and electrical requirements.

Fluid Delivery Specifications

Details on RP vial, concentration, and fluid volumes.

EMC and Mobility Specifications

Electromagnetic compatibility and system mobility features.

Appendix C - Troubleshooting Tips

Recovering from Priming Issues

Steps to resolve errors during or after priming.

Recovering from Air Detector Activation

Troubleshooting air detection issues during priming or test inject.

Recovering a Dose Due to System Failure

Procedures for handling system failures during dose preparation or infusion.

PAS Occlusion Recovery

Identifying and resolving occlusions in the PAS.

System Messages

List of error codes, messages, and their explanations.

Appendix D - Vials and Vial Shields

Vial Shield and Vial Specifications

Tables detailing vial shield and vial dimensions and compatibility.

Appendix E - Components and Catalog Numbers

System Components and Catalog Numbers

List of system parts and their corresponding catalog numbers.