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WORLD OF MEDICINE Manuals
Medical Equipment
FM300
Instructions for use manual
WORLD OF MEDICINE FM300 Instructions For Use Manual
Co2 conditioning insufflator
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Contents
Table of Contents
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Table of Contents
Table of Contents
1 Important User Notes
2 Safety Information
3 General Information
Device Description
Intended Use
Intended Use and Contraindications
Contraindications
General Warnings CO Insufflation
Warnings
Warnings Standard and High Flow/Bariatric Operating Mode
Warnings Pediatric Operating Mode
Warnings Vessel Harvest Operating Mode
Warnings TAMIS Operation Mode
General Precautions
En
Device Setup and Connection
Initial Device Setup
Fig. 4-1 Device Front
Front of the Device
Fig. 4-2 Device Rear
Gas Connection
Rear of the Device
Connecting a Gas Bottle
Fig. 4-3 Connecting the Gas Supply to the Angled Gas Connector
Connecting to Central Gas Supply
Gas Supply
Fig. 4-4 Setting up the Device
Switching Device off
Switching Device on
Draft
Fig. 5-1 Screen Displays
Insufflation Tube Sets
Monitor with Touch Screen
Operating the Device - General
Connecting an Insufflation Tube Set
Using Gas Heating
Fig. 5-2 Smoke Evacuation Indicator
Using the Smoke Evacuation Function
Fig. 5-3 Connections of the Tube Set with Smoke Evacuation
Fig. 5-4 Filling the Gas Humidification Tube
Use of Insufflation Gas Humidification Function
Fig. 5-5 Insufflation Gas Humidification Indicator
Fig. 5-6 Connecting the Pneumoclear to the Device Control
Using Device Control
Displaying/Selecting Insufflation Operating Mode
Setting the Nominal Pressure - All Operating Modes
Unlocking Operating Modes
Running Function Tests before Device Use
Setting the Nominal Flow - All Operating Modes
Gas Consumption Display
Starting/Stopping Insufflation
Desufflation
Fig. 5-7 Confirming or Denying Desufflation
Operating Modes of the PNEUMOCLEAR™ Insufflator
Standard Operating Mode
High Flow/Bariatric Operating Mode
Pediatric Operating Mode
Advanced Flow Operating Mode
Vessel Harvest Operating Mode
TAMIS Operating Mode
Menu (Overview)
Automatic Venting System
Occlusion
Safety Functions
Contamination
Leakage Detection
Care and Maintenance
Cleaning the Device
Maintenance by Authorized Service Technician
Maintenance Intervals
Replacing the Fuse
Fig. 9-1 Opening the Fuse Holder
En
Annual Inspection
Basic Function Test (in Standard Operating Mode)
Electrical Safety Test
Fig. 10-1 Pressure Sensor Test Setup
Pressure Sensor Test (Standard Operating Mode)
Fig. 10-2 Connections for Maximum Device Pressure Test
Maximum Device Pressure Test
Pressure Monitoring Test (in Standard Operating Mode)
Venting Valve Test
Gas Flow Rate Test
Electrical Connections
Electromagnetic Compatibility
Guidance and Manufacturer's Declaration - Electromagnetic Emissions
Error and Warning Messages
Technical Data
Draft
Accessories
Warranty and Service
16 Glossary
17 Appendix
List of Figures en
Index
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Maintenance Intervals
2
Care and Maintenance
3
Annual Inspection
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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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