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Stryker Flosteady Arthroscopy Pump 200 User Manual

Stryker Flosteady Arthroscopy Pump 200
272 pages
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2017/08 www.stryker.com 1000-400-982-Rev. H
EN
DE
FR
NL
PL
Flosteady
Arthroscopy PuMp
®
Irrigation Pump for Arthroscopy
Spülpumpe für die Arthroskopie
Pompe d'irrigation pour l'arthroscopie
Spoelpomp voor arthroscopie
Pompa płucząca do artroskopii
Manual
Handbuch
Manuel
Handboek
Instrukcja

Table of Contents

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Stryker Flosteady Arthroscopy Pump 200 Specifications

General IconGeneral
BrandStryker
ModelFlosteady Arthroscopy Pump 200
CategoryMedical Equipment
LanguageEnglish

Summary

Important User Notes

Key Safety and Usage Guidelines

Read the manual carefully and understand warnings, cautions, and notes for safe operation.

Safety Information

Waste Management and Battery Disposal

Disposal of electrical and electronic equipment and batteries according to EU directives.

General Safety Warnings

Contains warnings regarding technique, accessories, electrical shock, and functional tests.

Device Operation and Maintenance Warnings

Warnings related to device replacement, cleaning, condensation, and fuse replacement.

Device Purpose

Application Scope and Contraindications

Details the intended use of the FLOSTEADY Arthroscopy Pump and its contraindications.

Specific Device Dangers

Highlights dangers such as fluid extravasation, overpressure, and DEHP content in tubes.

Operational Safety and Precautions

Covers setup, device defects, endoscope compatibility, fluid bags, and electrical interference.

Battery Safety and Handling

Provides safety instructions for battery handling, charging, and replacement.

Manufacturer's Device Version Notice

Lists available languages for the device based on item numbers.

Initial Device Startup

Installing the Device

Instructions for delivery inspection, returning the device, and setting up the device on a stand.

Device Power Supply

Details operation via rechargeable battery pack or mains power supply.

Operating the Device

Device Front Panel Controls

Familiarization with control and function elements on the front of the device.

Device Rear Connections

Familiarization with connection elements on the rear of the device.

Turning the Device On

Steps to power on the device, including initialization and device check.

Device Setup and Joint Selection

Guides through device setup, battery status, and selecting the joint type and pressure/flow.

Handling Prematurely Inserted Tube Sets

Instructions for prompts displayed when a tube set is inserted before device check.

Handling Unsuccessful Device Checks

Describes displays and error messages following an unsuccessful device check.

Inserting the Cassette Tube Set

Detailed steps and diagram for inserting the sterile packaged cassette tube set.

Connecting the Fluid Bags

Instructions for connecting fluid bags to the device using tap spikes and tube sections.

Starting the Pump Function

Steps to start the pump, including prompts for inserting the tube set.

Using the Wash Function

Activates the 'Wash' function to improve visibility within the joint.

Using the Turbo Function

Activates the 'Turbo' function for improved visibility in difficult surgical conditions.

Using the Speed Mode

Explains the 'Speed' mode for maintaining pressure and raising actual pressure quickly.

Charging the Battery

Details automatic charging, battery status indicators, and operating time.

Safety Functions

Device Self-Test Procedures

Describes the device's self-test for sensors, motor, and electronics upon startup.

Safety and Warning Messages

Details messages displayed during operation, including tube set placement warnings.

Exceeding Nominal Pressure

Explains how the pump handles overpressure situations and critical overpressure warnings.

User Menu

User Menu Configuration

Guides through accessing and configuring user menu settings like language and brightness.

Options

Device Options: Wired Remote Control

Details the operation and functions of the autoclaveable wired remote control.

Function Test

Preparing the Function Test

Ensures fluid bags meet specifications and are suspended properly before testing.

Starting the Device for Function Test

Steps to turn on the device, insert the cassette, connect instrument, and select joint.

Performing the Function Test

Guides on selecting values and running the pump test outside of a joint.

Checking the Wash Function

Tests the 'Wash' function by activating it and observing pressure/flow rate changes.

Ending the Function Test

Confirms successful completion of the function test and readiness for use.

Using the Device during Surgery

Using the Device During Surgery

Provides instructions for selecting pressure/flow, starting the pump, and inserting the instrument.

Stopping Irrigation and Post-Surgery Procedures

Steps to stop irrigation, turn off the device, and remove tubing, with hygiene notes.

Care and Maintenance

Maintenance by Authorized Service Technician

Details service intervals, authorized personnel, liability, and technical documentation.

Cleaning the Device

Instructions for cleaning the device using a soft cloth and approved disinfectants.

Cleaning the Autoclaveable Remote Control

Guidelines for cleaning the remote control with mild cleaners and a brush.

Disinfecting the Autoclaveable Remote Control

Procedures for disinfecting the remote control with neutral or alkaline disinfectants.

Sterilizing the Autoclaveable Remote Control

Information on tested sterilization cycles and procedures for the remote control.

Replacing the Fuse

Step-by-step guide on how to safely replace the device's fuse.

Storing and Replacing the Battery

Guidelines for storing uninstalled batteries and when they need replacement.

Annual Inspection

Electrical Safety Test

Covers visual inspection and touch current measurement according to safety standards.

Basic Function Test

Checks device displays, keys, and performance using specific tools and consumables.

Pressure Measuring Test

Tests pressure chamber, sensors, and measuring system using water column for calibration.

Technical Data

Technical Data Specifications

Provides comprehensive technical specifications including power, dimensions, and operating conditions.

Guidelines and manufacturer's statement - electromagnetic compatibility

Impact of Mobile HF Communication Devices

Warns against operating mobile communication devices near the electrical medical device.

Electrical Connections and ESD Precautions

Advises on safe electrical connections and electrostatic discharge (ESD) measures.

Compatible Accessories

Lists compatible accessories, such as the autoclavable wired remote control.

Electromagnetic Emissions Guidelines

Details compliance and guidelines for electromagnetic emissions from the device.

Electromagnetic Interference Immunity

Covers immunity tests for ESD, transients, surges, power supply fluctuations, and magnetic fields.

EMC Immunity for FLOSTEADY Arthroscopy Pump

Specifies immunity levels and recommended safety distances for HF interference.

Recommended Safety Distances for HF Devices

Provides calculation formulas and tables for safe distances from HF telecommunication devices.

Accessory List

Accessory List

Lists order numbers and descriptions for accessories, including instructions for use and tube sets.

Error and Warning Messages

Error and Warning Messages

Lists error messages, their causes, and troubleshooting steps for device malfunctions.

Glossary

Glossary of Terms

Defines key terms used in the manual, such as flow rate, contamination, and OP mode.

Warranty and Service

Warranty and Service Information

Details the product warranty, exclusions, and procedures for service and repair.

Service and Claims Procedures

Provides instructions on how to contact Stryker Endoscopy for service and claims during or after warranty.

Appendix

Appendix: Test Log

Provides a template for recording test results, comments, and signatures.

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