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TransMedics Organ Care System User Manual

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PN 100004070, REV 6 Page 1
TransMedics
®
Organ Care System
Technical User Guide: OCS
TM
Lung System
Software Version 3.1.2
PN 100004070 Rev 6
REF 2103
2797
© 2019 by TransMedics, Inc. All rights reserved. Printed in U.S.A.

Table of Contents

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TransMedics Organ Care System Specifications

General IconGeneral
BrandTransMedics
ModelOrgan Care System
CategoryMedical Equipment
LanguageEnglish

Summary

CHAPTER 1: READ THIS FIRST

Directions to User

Overview of the manual and system use.

User Training Requirements

Details required training for medical professionals.

Indications for Use

Describes the intended medical applications of the system.

Document Conventions and Warnings

Explains symbols, formatting, and safety notices.

System Updates and Contact Information

Information on upgrades, supplies, and how to contact TransMedics.

CHAPTER 2: SAFETY INFORMATION

Electrical Safety Precautions

Warnings and cautions for safe electrical operation.

Mechanical, System, and Operator Safety

Guidelines for handling, cleaning, and safe use.

Patient and Organ Safety Considerations

Safety measures related to organ preservation.

Component Safety and Handling

Guidelines for inspecting and using system components.

Aseptic Technique and System Mobility

Procedures requiring sterile practices and safe system movement.

Shipping, Storage, and Hazard Warnings

Specifies transport/storage conditions and hazards like explosion risk.

Electromagnetic Compatibility and Battery Handling

EMC standards and safety for battery management.

Gas Cylinder Safety and Disposal Procedures

Precautions for using gas cylinders and equipment disposal.

CHAPTER 3: OVERVIEW

System Components Overview

Lists and describes the main parts of the OCS system.

Key System Modules and Accessories

Details the Wireless Monitor, Probes, Gas Cylinders, and Batteries.

Lung Perfusion Set Components

Outlines the sterile components for organ preservation.

System Operation Overview

Introduces system operation, modes, circuits, and ports.

CHAPTER 4: SYSTEM SETUP AND CONNECTIONS

Powering and Battery Management

Instructions for AC power connection and battery checks.

Wireless Monitor Connection Procedures

Steps for docking and undocking the Wireless Monitor.

Gas Cylinder and Data Card Management

Guidance on using, returning gas cylinders and using data cards.

Replacing a Yoke Gasket and Mobile Base Usage

Instructions for seal replacement and mobile base operation.

CHAPTER 5: WIRELESS MONITOR OVERVIEW

Wireless Monitor Components and Controls

Identifies monitor parts and explains their operation.

Wireless Monitor Display Elements and Status

Describes screen layout, parameters, graphs, and status icons.

CHAPTER 6: MANAGING THE SYSTEM

Session Management and Menu Navigation

Procedures for starting sessions and using system menus.

System Configuration and Settings Management

Adjusting operational parameters, alarms, and system settings.

Pump Adjustment and Alarm Response

Controlling pump flow and responding to system alarms.

Waveform and Trend Data Analysis

Displaying and analyzing real-time and historical data.

Perfusion Clock, Sample Data, and Annotations

Managing session timer, inputting data, and adding notes.

Probe Calibration and System Status Review

Calibrating probes and reviewing current system status.

CHAPTER 7: CLEANING AND MAINTAINING THE OCS™

System Inspection and Safety Precautions

Procedures for inspecting, handling components, and infection control.

Cleaning and Disinfection Procedures for System and Probes

Detailed steps for cleaning the system and its probes.

Cleaning and Maintenance Task Summary

A summary checklist for maintenance activities.

CHAPTER 8: SYSTEM SPECIFICATIONS

Safety, Regulatory, and Electrical Specifications

Compliance and technical details on power and safety.

Physical, EMC, and Performance Specifications

Details on weight, EMC, and essential functions.

Accuracy of Displayed Values

Specifications for measurement accuracy.

CHAPTER 9: TROUBLESHOOTING

Emergency Support and Service Contact Information

Contacting support and service for urgent issues.

Troubleshooting Pump, Ventilation, and Heating Issues

Guidance for resolving common operational problems.

Troubleshooting Probes, Wireless Monitor, and Power

Guidance for resolving probe, monitor, and power issues.

Troubleshooting SD Card and System Errors

Guidance for resolving data card and system error messages.

System Reset and Monitor Failure Procedures

Procedures for resetting the system and addressing monitor issues.

Equipment Service and Bellows Alignment Guidance

Guidelines for shipping equipment and aligning the bellows plate.

Known Software Limitations and Mitigations

Lists potential issues with the OCS™ software and recommended steps.

CHAPTER 10: PARTS AND SUPPLIES

Ordering Information and Contact Details

How to reach TransMedics for purchasing parts.

Catalog of Parts and Supplies

Lists available parts and their descriptions.

APPENDIX A. SYMBOL GLOSSARY

Glossary of Packaging Symbols

Explains the meaning of various symbols used on product packaging.

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