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DeRoyal Prospera PRO Series - User Manual

DeRoyal Prospera PRO Series
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SAFETY US-CA
E355754
USER MANUAL
DeRoyal
®
Prospera
®
PRO Series
Negative Pressure Wound Therapy System
PRO-II
®
and PRO-III
®
AS TO ELECTRICAL SHOCK,
FIRE AND MECHANICAL HAZARDS
ONLY IN ACCORDANCE WITH
ANSI/AAMI ES60601-1 (2005),
CAN/CSA-C22.2 No. 60601-1
(2008)

Table of Contents

Questions and Answers

Summary

User Information and Manual Navigation

1.1 How to Use this Instruction Manual

Guidance on how to read and use the user manual effectively.

1.2 Understanding Icons and Symbols

Explanation of symbols used in the manual and on the device for clarity.

Glossary and Symbol Conventions

1.3 Symbol Conventions

Defines conventions used for symbols like enumeration and process order.

1.4 Glossary of Terms

Provides definitions for technical terms and abbreviations used in the manual.

Intended Use and Safety Guidance

1.5 Intended Use of Therapy Systems

Details the purpose and applications for which the negative pressure wound therapy systems are indicated.

1.5.1 Indications and Contraindications

Lists recommended uses and conditions where the devices should not be used.

1.5.3 Safety Precautions

Highlights critical safety measures and conditions to be aware of during use.

1.5.4 Restrictions on Use

Outlines specific environments or situations where the device's use is restricted.

1.6 Basic Safety Instructions

Provides essential safety guidelines to prevent hazards related to handling and operation.

1.6 Basic Safety Instructions (Continued)

Additional safety guidelines and warnings for device handling and operation.

User Requirements and Product Information

1.7 Operator Requirements and Training

Specifies the necessary qualifications and training for operating the device.

1.8 Product Liability Information

Outlines conditions under which the operator is liable for the device's operation.

1.9 Material Compatibility Warnings

Warns about potential damage from aggressive substances and advises on care.

Product Description and Contents

2.1.1 PRO-II Device Components

Illustrates and labels the components of the PRO-II® device.

2.1.2 PRO-II Package Contents

Lists all items included in the package for the PRO-II® device.

2.1.3 PRO-III Device Components

Illustrates and labels the components of the PRO-III® device.

2.1.4 PRO-III Package Contents

Lists all items included in the package for the PRO-III® device.

Product Properties and Features

2.2.1 PRO-II Exudate Canister Features

Details the features and single-use nature of the PRO-II® exudate canister.

2.2.2 PRO-II Filter System Details

Explains the filter system for the PRO-II® device and its service life.

2.2.3 PRO-II Carbon Filter Function

Describes the function and replacement of the carbon filter in the PRO-II® device.

2.2.4 PRO-III Exudate Canister System

Details the features and single-use nature of the PRO-III® exudate canister system.

2.2.5 PRO-III Double Filter System

Explains the double filter system for the PRO-III® device and its service life.

2.2.6 Battery Information and Charging

Details battery type, charging recommendations, and operational service life.

2.2.7 Pressure Setting Adjustments

Explains how pressure settings are adjusted by healthcare professionals.

Warranty Information

2.3 Warranty Terms and Conditions

Outlines the warranty terms, coverage, and conditions for the devices.

Setup and Startup Procedures

3.1.1 Initial Startup Guide

Step-by-step guide for initial device setup and preparation before operation.

3.1.2 Connecting Devices to Power Supply

Instructions on how to connect the devices to the power supply for charging or operation.

3.1.3 Device Positioning

Guidance on the optimal placement of the PRO-II® and PRO-III® devices relative to the patient.

3.1.4 Connecting PRO-II Exudate Canister

Steps for attaching the exudate canister to the PRO-II® device.

3.1.6 Connecting PRO-III Exudate Canister System

Instructions for connecting the exudate canister system to the PRO-III® device.

3.1.7 Connecting Wound Drainage System

How to connect the suction tube to the wound drainage system.

Device Operation Modes

3.2.1 Initial Startup Operation

Detailed steps for operating the device upon first use.

3.2.2 Continuous Operation Mode

Instructions for operating the device in continuous mode, including setting pressure.

3.2.3 Intermittent Operation Mode

Instructions for operating the device in intermittent mode, including setting pressure and time.

3.2.4 Language Selection

How to select and customize the device's display language.

3.2.5 Alarm Delay at Startup

Explanation of the 60-second delay for specific alarms during startup.

Patient Mode and Alarm Settings

3.3 Patient Mode Activation and Authorization

Steps to activate patient mode and enter the authorization code.

3.3 Alarm Sensitivity Adjustment

How to adjust alarm sensitivities for 'System closed' and 'Check dressing seal'.

3.3 Patient Runtime Management

How to view and reset the patient runtime.

Canister Exchange Procedures

3.4.1 PRO-II Canister Exchange

Step-by-step instructions for replacing the PRO-II® device's exudate canister.

3.4.2 PRO-III Canister Exchange

Step-by-step instructions for replacing the PRO-III® device's exudate canister.

Maintenance and Disposal

4.1.1 General Maintenance Information

General guidance on handling infectious materials and disinfectants during maintenance.

4.1.2 Device Cleaning and Disinfection

Procedures for cleaning and disinfecting the device surfaces.

4.1.3;4.1.4 Disposal of Canisters and Tubing

Instructions for the proper disposal of exudate canisters and suction tubes.

4.2 Maintenance and Service

Information on maintenance requirements, service, and authorized repairs.

4.3 Device Testing Services

Information on testing services offered for the devices.

Troubleshooting and Error Resolution

5.1 Performing a Function Test

Steps to perform a function test of the device before therapy.

5.2 Troubleshooting Common Malfunctions

Common malfunctions, their probable causes, and remedies.

5.3 Error Message Guide

Identifies error messages, their status, probable causes, and remedies.

5.3 Error Message Guide (Continued)

Identifies additional error messages, their status, probable causes, and remedies.

Transport, Storage, and Disposal

6.1 Decontamination for Shipment

Procedures for cleaning and disinfecting devices before shipment or transfer.

6.2 Device Storage Recommendations

Guidelines for proper storage of the devices, including battery charging.

6.3 Component Disposal Guidelines

Instructions for the environmentally responsible disposal of device components.

Technical Data and Specifications

7.1 PRO-II Technical Data

Detailed technical specifications for the PRO-II® device.

7.2 PRO-III Technical Data

Detailed technical specifications for the PRO-III® device.

7.3 EMC Information and Precautions

Information regarding electromagnetic compatibility and precautions for installation and use.

Ordering Information

8.1 PRO-II Device Ordering Information

Lists item numbers and descriptions for the PRO-II® device and its accessories.

8.2 PRO-III Device Ordering Information

Lists item numbers and descriptions for the PRO-III® device and its accessories.

DeRoyal Prospera PRO Series Specifications

General IconGeneral
BrandDeRoyal
ModelProspera PRO Series
CategoryMedical Equipment
LanguageEnglish

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