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WORLD OF MEDICINE Stryker Pneumoclear User Manual

WORLD OF MEDICINE Stryker Pneumoclear
77 pages
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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 Stryker Pneumoclear Specifications

General IconGeneral
BrandWORLD OF MEDICINE
ModelStryker Pneumoclear
CategoryMedical Equipment
LanguageEnglish

Summary

Stryker PNEUMOCLEAR CO₂ Conditioning Insufflator

Instructions for Use

Provides instructions for operating the Stryker PNEUMOCLEAR CO₂ Conditioning Insufflator.

Surgical Procedure Applications

Details the insufflator's use in laparoscopy, vessel harvesting, and colorectal procedures.

Important User Notes

Safety and Usage Warnings

Highlights critical warnings, cautions, and notes for safe device operation.

Safety Information

General Information

Device Description and Modes

Describes the PNEUMOCLEAR™ insufflator, its modes, and functionalities.

Intended Use and Contraindications

Specifies the intended use and conditions where the device should not be used.

Warnings and Precautions

General CO₂ Insufflation Warnings

Covers general safety warnings related to CO₂ insufflation procedures.

Mode-Specific Warnings

Standard & High Flow/Bariatric Mode Risks

Details risks like CO₂ absorption, metabolic reactions, and hypothermia.

Pediatric Mode Hazards

Highlights risks such as gas flow limits, airway pressure, and cardiovascular issues.

Initial Device Setup

Device Rear Panel and Gas Connection

Gas Supply Requirements

Stresses using pure CO₂ and maintaining adequate gas supply.

Gas Supply Setup

Connecting a Gas Bottle

Details the procedure for connecting a CO₂ gas bottle.

Central Gas Supply Connection

Connecting to Central Gas Supply

Details the procedure for connecting to a central gas supply.

Device Powering On and Off

Switching the Device On

Guides through the procedure for turning the device on.

Switching the Device Off

Details the procedure for safely turning the device off.

Operating the Device - General

Touch Screen Interface

Describes the device's touch screen interface and its displays.

Insufflation Tube Sets

Details the different types of insufflation tube sets available.

Tube Set Connection and Gas Heating

Connecting the Insufflation Tube Set

Provides step-by-step instructions for connecting an insufflation tube set.

Smoke Evacuation Function

Smoke Evacuation Operation

Details how to use the smoke evacuation function.

Operating Mode Selection and Pressure Settings

Displaying and Selecting Operating Modes

Guides on how to display and select different operating modes.

Setting Nominal Pressure

Details how to set the nominal pressure for all operating modes.

Nominal Flow Settings and Veress Insufflation

Setting Nominal Flow

Details how to set the nominal flow for all operating modes.

Function Tests Before Use

Guides on performing essential function tests before device use.

Function Tests and Leak Detection

Functional Test Requirements

Stresses the necessity of completing the functional test before surgery.

Leak Detection Procedures

Warns about leaks and guides on locating them.

Gas Consumption and Insufflation Control

Starting and Stopping Insufflation

Describes how to start and stop the insufflation process.

PNEUMOCLEAR™ Insufflator Operating Modes

High Flow/Bariatric Operating Mode

Pediatric Operating Mode

Advanced Flow and Vessel Harvest Modes

Advanced Flow Operating Mode

Describes the Advanced Flow Operating Mode and its applications.

Vessel Harvest Operating Mode

Describes the Vessel Harvest Operating Mode and its applications.

TAMIS Operating Mode

Safety Functions

Care and Maintenance

Authorized Service Technician Requirements

Outlines the requirements for maintenance by authorized service technicians.

Device Safety and Fuse Replacement

Replacing the Device Fuse

Provides instructions for replacing the device fuse.

Annual Inspection Procedures

Basic Function Test

Details the basic function test for the Standard Operating Mode.

Pressure Sensor and Gas Extraction Tests

Pressure Sensor Test

Provides steps for testing the pressure sensor in Standard Mode.

Pressure Monitoring and Valve Tests

Pressure Monitoring Test

Details the pressure monitoring test procedure.

Gas Flow Rate Test

Gas Flow Rate Test Procedure

Provides instructions for performing the gas flow rate test.

Error and Warning Messages

Technical Data

Accessories and Manuals

Warranty and Service Information

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