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Greenlight XPS User Manual

Greenlight XPS
29 pages
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Boston Scientific (User’s Manual Template 8.5in x 11in Global, 91091755 Rev/Ver. AA), Manual, MB, XPS, Global, 50623316-01A_pretrans
Black (K) ∆E ≤5.0
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TABLE OF CONTENTS
1 DEVICE DESCRIPTION ......................................................................................................................................................................................................................3
1.1 Console .....................................................................................................................................................................................................................................3
1.2 FiberLife ....................................................................................................................................................................................................................................3
1.3 Vaporization .............................................................................................................................................................................................................................3
1.4 Coagulation ..............................................................................................................................................................................................................................3
1.5 User Information .....................................................................................................................................................................................................................3
1.6 Contents....................................................................................................................................................................................................................................3
2 INTENDED USE/INDICATIONS FOR USE .......................................................................................................................................................................................3
3 CONTRAINDICATIONS ...................................................................................................................................................................................................................... 4
4 WARNINGS ......................................................................................................................................................................................................................................... 4
5 PRECAUTIONS....................................................................................................................................................................................................................................4
6 ADVERSE EVENTS .............................................................................................................................................................................................................................5
6.1 Some Adverse Events Further Explained ............................................................................................................................................................................ 6
6.2 Complications And Risks By Indication ..............................................................................................................................................................................7
7 HOW SUPPLIED..................................................................................................................................................................................................................................8
7.1 Handling and Storage.............................................................................................................................................................................................................8
8 SAFETY ................................................................................................................................................................................................................................................8
8.1 Eye Injury .................................................................................................................................................................................................................................. 8
8.2 Burns ......................................................................................................................................................................................................................................... 9
8.3 Reflection of the Beam From Instruments ..........................................................................................................................................................................9
8.4 Ignition of Flammable Materials ........................................................................................................................................................................................... 9
8.5 Electrical...................................................................................................................................................................................................................................9
8.6 Operating Room Environment ...............................................................................................................................................................................................9
8.7 Safety Features of the Laser System ................................................................................................................................................................................. 10
9 CONSOLE DESCRIPTION ................................................................................................................................................................................................................11
10 ACCESSORIES ................................................................................................................................................................................................................................13
10.1 Video Camera Insert .......................................................................................................................................................................................................... 13
10.2 Laser Protective Eyewear .................................................................................................................................................................................................13
11 INSTALLATION ...............................................................................................................................................................................................................................13
11.1 Responsibility of BSC .........................................................................................................................................................................................................13
11.2 Responsibility of Customer ................................................................................................................................................................................................ 13
11.3 Positioning of the Console ................................................................................................................................................................................................. 13
11.4 Power Requirements .......................................................................................................................................................................................................... 13
12 INSTRUCTIONS FOR USE .............................................................................................................................................................................................................14
12.1 Touchscreen and Footswitch ............................................................................................................................................................................................ 14
12.2 Preparation ..........................................................................................................................................................................................................................14

Questions and Answers:

Greenlight XPS Specifications

General IconGeneral
BrandGreenlight
ModelXPS
CategoryMeasuring Instruments
LanguageEnglish

Summary

Device Description

Console Overview

Details the main unit, its components, and features.

FiberLife Component

Describes the specific fiber used with the laser system.

Vaporization Functionality

Explains the vaporization function of the laser system.

Coagulation Functionality

Details the coagulation function of the laser system.

User Information and Qualification

Specifies who is qualified to use the laser system.

System Package Contents

Lists the items included in the system package.

Intended Use and Indications

General Surgery Indications

Use of the laser system in general surgical procedures.

Gynecology Indications

Use of the laser system in gynecological procedures.

Neurosurgery Indications

Use in neurosurgical procedures.

Ophthalmology Indications

Use in ophthalmological procedures.

Spinal Surgery Indications

Use in spinal surgical procedures.

Plastic Surgery Indications

Use in plastic surgical procedures.

Thoracic Surgery Indications

Use in thoracic surgical procedures.

Urology Indications

Use in urological procedures.

Contraindications

General Surgery Contraindications

Contraindications for general surgical use.

Gastroenterology Contraindications

Contraindications for gastroenterological use.

Gynecology Contraindications

Contraindications for gynecological use.

Neurosurgery Contraindications

Contraindications for neurosurgical use.

Ophthalmology Contraindications

Contraindications for ophthalmological use.

Warnings

Precautions

Adverse Events

Abdominal Bloating (Intestinal Gas)

A potential gastrointestinal side effect of the procedure.

Acute Renal Failure

A serious potential kidney-related adverse event.

Allergic Reaction

An immune system response to treatment.

Aspiration

Inhalation of foreign material into the lungs.

Bladder Neck Contracture

Narrowing of the bladder neck, potentially affecting urine flow.

Bladder Spasm

Involuntary contraction of the bladder muscle.

Bleeding

Unintended loss of blood during or after procedure.

Burn

Tissue damage caused by excessive heat.

Chills

Feeling cold, often associated with fever.

Clot Retention

Inability to empty the bladder due to blood clots.

Further Explanation of Adverse Events

Bleeding Events Explained

Detailed explanation of bleeding events post-procedure.

Fever and Leukocytosis Explained

Explanation of fever and increased white blood cell count.

Pain Explained

Explanation of pain experienced by patients.

Complications and Risks by Indication

General Surgery Complications

Specific risks and complications for general surgery.

Gastroenterology Complications

Specific risks and complications for gastroenterology.

Gynecology Complications

Specific risks and complications for gynecology.

Head and Neck/Otorhinolaryngology (ENT) Complications

Specific risks and complications for ENT procedures.

Neurosurgery Complications

Specific risks and complications for neurosurgery.

Ophthalmology Complications

Specific risks and complications for ophthalmology.

Spinal Surgery Complications

Specific risks and complications for spinal surgery.

Plastic Surgery Complications

Specific risks and complications for plastic surgery.

Thoracic Surgery Complications

Specific risks and complications for thoracic surgery.

Urology Complications

Specific risks and complications for urology.

How Supplied

Handling and Storage Guidelines

Guidelines for handling and storing the system components.

Storage and Transport Instructions

Instructions for storing and transporting the laser system.

Safety

Eye Injury Prevention

Information on preventing eye injuries from laser light.

Burn Prevention

Guidance on preventing burns during laser operation.

Reflection of Beam from Instruments

Risks associated with beam reflection from instruments.

Ignition of Flammable Materials

Precautions against igniting flammable materials.

Electrical Safety

Safety considerations regarding electrical components.

Operating Room Environment Safety

Safety measures specific to the operating room.

Laser System Safety Features

Overview of built-in safety mechanisms of the laser system.

Console Description

Console Front View: Screen/Touchscreen

Description of the console's display and input interface.

Console Front View: Card Reader

Function of the card reader on the console.

Console Front View: Storage Compartment

Location and purpose of the storage compartment.

Console Front View: Fiber Shield

Description of the fiber shield's protective function.

Console Front View: Fiber Pole

Details the fiber pole's role in positioning the fiber.

Console Front View: Fiber Port Cover

Covers the connection port for the laser fiber.

Console Front View: Emergency Laser Stop

Location and function of the emergency stop button.

Console Front View: On/Off Key Switch

Controls power and access to the console.

Console Front View: Footswitch

Controls laser emission during operation.

Console Back View: Back Handle

Describes the console's rear handle.

Console Back View: Upper Power Cord Storage Hook

Hook for storing the power cord.

Console Back View: Foot switch Cord Storage Hook (1)

One of the hooks for storing the footswitch cord.

Console Back View: Foot switch Cord Storage Hook (2)

Another hook for storing the footswitch cord.

Console Back View: Footswitch Connection

Port for connecting the footswitch.

Console Back View: Service Port

Port for factory service use only.

Console Back View: Remote Interlock Socket

Socket for the remote door interlock connection.

Console Back View: Coolant Reservoir

Contains the internal cooling liquid.

Console Back View: Coolant Drain

Port for draining the cooling liquid.

Console Back View: AC Power Cord

Power connection for the console.

Console Back View: Lower Power Cord Storage Hook

Another hook for storing the power cord.

Console Back View: Circuit Breaker

Protects the console against electrical overload.

Console Back View: Wheel Lock

Secures the console's wheels to prevent movement.

Accessories

Video Camera Insert

Component for integrating a video camera with the system.

Laser Protective Eyewear

Essential eyewear for protecting against laser radiation.

Installation

Boston Scientific's Installation Responsibility

Defines Boston Scientific's role in system installation.

Customer's Installation Responsibility

Defines customer responsibilities for system installation.

Console Positioning Guidelines

Guidelines for optimal console placement during installation.

Power Requirements for Installation

Electrical specifications required for powering the system.

Instructions for Use

Touchscreen and Footswitch Operation

Operation of the console's interface and foot pedal controls.

Pre-Procedure Preparation Steps

Steps to prepare the system and patient before use.

Procedure Steps

Step-by-step guide for performing the laser procedure.

Post-Procedure Steps

Steps to follow once the laser procedure is completed.

Technical Data

Safety Classifications and EMC

Classification and Electromagnetic Compatibility information.

Maintenance

Console Care and Cleaning

Routine cleaning and maintenance procedures for the console.

Preventative Maintenance Schedule

Scheduled maintenance to ensure optimal system performance.

Coolant Refill Instructions

Procedures for refilling the system's coolant reservoir.

Detailed Coolant Refill Steps

Detailed steps for refilling the coolant.

End of Useful Life Information

Information regarding the system's lifespan and disposal.

Troubleshooting

Courtesy Messages Explained

Explanation of system courtesy messages and their meanings.

Service Prompts and Error Codes

Details of error codes and service prompts.

Warranty Information

Warranty Limitation Terms

Terms and conditions limiting the product warranty.

Additional Warranty Terms for Mobile Systems

Specific warranty terms applicable to mobile system units.

System Transport Guidelines

Guidelines for safely transporting the laser system.