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WORLD OF MEDICINE FM300 User Manual

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Insufflator for Laparoscopy, Vessel Harvesting, and Colorectal Procedures
P31693 Rev. K
Instructions for Use
en
DRAFT

Table of Contents

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WORLD OF MEDICINE FM300 Specifications

General IconGeneral
BrandWORLD OF MEDICINE
ModelFM300
CategoryMedical Equipment
LanguageEnglish

Summary

Important User Notes

Safety Information

General Information

Device Description and Operating Modes

Describes the PNEUMOCLEAR insufflator, its functions, and available operating modes.

General Information

Mode-Specific Safety Warnings (Standard/High Flow)

Mode-Specific Safety Warnings (Pediatric)

Pediatric Mode Safety and Parameter Warnings

Addresses gas flow limits, airway pressure, pneumolabium, and cardiovascular risks in pediatric use.

Initial Device Setup

Gas Bottle Connection and Safety Cautions

Provides instructions for connecting a gas bottle, including high-pressure hose and riser pipe cautions.

Central Gas Supply Connection and Gas Status Monitoring

Guides on connecting to central gas supply and explains gas supply monitoring indicators.

Device Power On, Configuration, and Power Off

Details device power on sequence, initial configuration, and safe power off procedure.

Initial Device Setup

Operating the Device - General

Touch Screen Monitor and Insufflation Tube Sets

Explains the touch screen interface, displays, and describes available insufflation tube sets.

Nominal Flow Setting and Pre-Use Function Tests

Details setting nominal flow rates, Veress insufflation, and necessary function tests before use.

Pre-Use Device Checks and Leak Detection Procedures

Provides steps for checking the device, including functional tests and identifying system leaks.

Operating the Device - General

Operating Modes of the PNEUMOCLEARTM Insufflator

Pediatric Mode Physiological and Haemodynamic Warnings

Details warnings on haemodynamic stability, hypothermia, and cardiovascular issues in pediatric use.

Standard Operating Mode Description and Parameters

Describes the Standard Operating Mode, its parameters, patient population, and related warnings.

Standard Mode Physiological and System Warnings

Details warnings related to CO2 absorption, metabolic issues, hypothermia, and dehydration in Standard Mode.

High Flow/Bariatric Mode Physiological Warnings

Details warnings on CO2 absorption, metabolic issues, and hypothermia for High Flow/Bariatric Mode.

Pediatric Operating Mode Parameters and Safety Warnings

Describes Pediatric Mode, its parameters, and specific safety warnings for children.

Advanced Flow and Vessel Harvest Operating Modes

Describes Advanced Flow and Vessel Harvest modes, their parameters, patient populations, and related warnings.

TAMIS Operating Mode Description and Warnings

Describes the TAMIS mode, its parameters, and specific warnings for pressure and CO2 absorption.

High Flow/Bariatric Operating Mode Description

Describes the High Flow/Bariatric mode, its parameters, patient population, and warnings.

Operating Modes of the PNEUMOCLEARTM Insufflator

Menu Structure and Settings Overview

Safety Functions

Automatic Venting System Operation and Warnings

Explains the automatic venting system for overpressure relief and related warnings.

Contamination Warnings, Procedures, and Leakage Detection

Details warnings and procedures for device contamination and explains leakage detection mechanisms.

Occlusion Detection, Warning Display, and Cautions

Describes the occlusion detection feature, warning display, and related cautions.

Care and Maintenance

Device Cleaning Procedures and Intervals

Provides recommended steps for cleaning the device and specifies maintenance intervals.

Authorized Service Technician Requirements and Liability

Specifies maintenance by authorized technicians, personnel qualifications, and liability.

Annual Inspection Procedures

Electromagnetic Compatibility

Error and Warning Messages

Technical Data and Specifications

Accessories and Documentation

Warranty and Service Information

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