WORLD OF MEDICINE FM300 Instructions For Use Manual

WORLD OF MEDICINE FM300 Instructions For Use Manual

Co2 conditioning insufflator
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Instructions for Use
Insufflator for Laparoscopy, Vessel Harvesting, and Colorectal Procedures
P31693 Rev. K

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Summarization of Contents

Important User Notes
User Guidance and Warnings
Provides essential notes, warnings, and cautions for proper device operation and safety.
Safety Information
General Safety, Liability, and Regulations
Covers liability, authorized technicians, care, contamination, waste, and U.S. federal law restrictions.
General Information
Device Description, Intended Use, and Contraindications
Details the device's purpose, operating modes, intended use, and conditions for non-use.
General Warnings and Precautions
Lists various safety warnings related to CO₂ insufflation and general precautions.
Initial Device Setup
Setup Location, Connections, and Gas Supply
Guidelines for device placement, ME system compatibility, ventilation, and gas connection procedures.
Device Components Overview
Identifies front and rear device components, user interface elements, and connections.
Operating the Device - General
Touchscreen Interface and Tube Set Management
Explains the touchscreen interface, tube set types, connection, and usage.
Functional Operations: Smoke Evacuation and Humidification
Instructions for using smoke evacuation and gas humidification features.
Device Control and Mode Selection
Covers remote device control, unlocking operating modes, and setting pressure/flow.
Pre-use Function Tests
Step-by-step guide for performing essential pre-use functional checks, including leak tests.
Gas Consumption and Insufflation Control
Explains gas consumption display and how to start/stop the insufflation process.
Starting/Stopping Insufflation
Instructions on how to initiate and terminate the insufflation process using device controls.
Desufflation Procedure
Describes the function to remove remaining CO₂ from the cavity after insufflation.
Operating Modes
Standard, High Flow/Bariatric, and Pediatric Modes
Details operating modes for general, bariatric, and pediatric procedures, including warnings.
Advanced Flow, Vessel Harvest, and TAMIS Modes
Describes specialized modes for high leaks, vessel harvesting, and transanal surgery.
Menu and Settings Overview
User Menu Configuration Options
Configuration options for pressure, flow rates, venting, and smoke evacuation levels.
System Settings and Upgrades
Covers audio, gas supply, language, software version, factory reset, and upgrades.
Safety Functions
Automatic Venting and Occlusion Detection
Manages overpressure and detects blockages in the system for safe operation.
Contamination and Leakage Handling
Procedures for handling device contamination and responding to leakage notifications.
Care and Maintenance
Cleaning, Inspection, and Service
Guidelines for cleaning, annual inspection, and tasks requiring authorized service technicians.
Service and Fuse Replacement
Procedures for service tasks performed by technicians and how to safely replace a fuse.
Annual Inspection Procedures
Safety, Basic Function, and Pressure Tests
Procedures for visual inspection, electrical safety, basic function, and pressure sensor tests.
Venting Valve, Max Pressure, and Flow Rate Tests
Tests to verify venting valve, maximum pressure capabilities, and gas flow rate accuracy.
Electromagnetic Compatibility
EMC Precautions, Connections, and Emissions
Guidelines for safe use concerning electromagnetic interference, electrical connections, and emissions.
Immunity Guidelines and RF Equipment Safety
Manufacturer's declarations on immunity and warnings regarding portable RF communication equipment.
Error and Warning Messages
Troubleshooting Common Errors and Warnings
Lists common error messages, their causes, and troubleshooting steps for resolution.
Technical Data
Device Specifications and Ratings
Key specifications including model, power, fuses, dimensions, weight, and interfaces.
Operating and Performance Limits
Details operating conditions, environmental requirements, and essential performance limits.
Accessories
List of Available Accessories and Parts
Comprehensive list of compatible accessories, tube sets, hoses, connectors, and spare parts.
Warranty and Service
Warranty Terms, Claims, and Service Procedures
Information on product warranty, exclusions, claims process, and necessary service contact details.
Glossary
Key Terminology Definitions
Explanations of technical terms like EMC, ME Device, and ME System used in the manual.
Appendix
Test Log Template
A template for recording test results, comments, and signatures for maintenance activities.

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