Boscarol OB500 LINER Operating Instructions Manual

Boscarol OB500 LINER Operating Instructions Manual

Medical suction unit
Table of Contents

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ED01_REV01-2021 IFU OB500_ENG
BOSCAROL MEDICAL SUCTION UNIT
OB500
FA / FM / LINER
OPERATING INSTRUCTIONS
OB500 WE FM
OB500 type A FA
OB500 IR LINER
OB500 ARI FA
1- 32

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Summarization of Contents

Manufacturer Information
Manufacturer Details and Quality Systems
Details about the manufacturer and their quality management system.
About These Operating Instructions
Explains the purpose and scope of the operating instructions.
Symbols and Pictograms
Instruction Symbols
Symbols used in the manual to draw attention to important information.
Device and Accessory Symbols
Symbols found on the suction unit and its accessories.
Intended Use of OB500 Suction Unit
Primary Medical Use
Describes the main purpose of the suction unit in medical settings.
Other Medical Applications
Lists alternative uses for the suction unit beyond primary function.
General Safety Warnings and Precautions
General Precautions for Safe Operation
Key safety information and warnings for operating the device correctly.
Important Information Before Initial Use
Periodic Safety Inspection Guidelines
Guidelines for routine safety checks and inspections of the unit.
User and Operator Responsibilities
Outlines the duties and responsibilities of the user and operator.
Contraindications and Potential Side Effects
Contraindications for Use
Situations or conditions where the device should not be used.
Possible Side Effects During Operation
Lists potential adverse effects that may occur during suction.
OB500 Medical Suction Unit Overview
Package Contents for FA Version
Lists all items included in the OB500 FA model package.
Package Contents for LINER Version
Lists all items included in the OB500 LINER model package.
OB500 Suction Unit Model Descriptions
Model OB500 FA Description
Details the components and features of the OB500 FA model.
Model OB500 LINER Description
Details the components and features of the OB500 LINER model.
OB500 FM Model and Control Panel
Model OB500 FM Description
Details the components and features of the OB500 FM model.
Controls and Operation of the Control Panel
Explains the functions of the device's control panel and buttons.
Key Suction Unit Components
Motor Block Unit (Suction Pump)
Describes the suction pump assembly and its installation.
Electrical Connections for the Unit
Details how to connect the suction unit to the vehicle's power supply.
Periodic Testing Procedures for OB500
Daily Periodic Test Procedure
Instructions for performing a daily functional check of the suction unit.
Test Results and Recommended Actions
Six-Monthly or Annual Periodic Test
Procedure for a comprehensive semi-annual/annual inspection of the unit.
Safety Information and Device Compliance
Safety Information for Users and Third Parties
General safety advice for users, patients, and third parties.
Suction Jars for OB500 Variants
Information on the different types of suction jars available for OB500.
Suction Jar Component Details
Autoclavable Secretion Collection Jar OB-J FA
Details on the reusable OB-J FA suction jar, including sterilization.
Antibacterial Filter Information
Information on the disposable antibacterial filter and its replacement.
OB-J FM Jar for SERRES® Disposable Bags
Describes the OB-J jar designed for use with SERRES® disposable bags.
Additional Suction Jar and Accessory Information
SERRES® Jar for OB500 LINER Model
Details on the SERRES® jar used with the OB500 LINER model.
Yankauer Catheter and Silicone Suction Tube
Information on the sterile Yankauer catheter and silicone suction tube.
Single-Use Part Warnings and Cleaning Overview
Warnings on Re-use of Disposable Parts
Cautionary advice regarding the reuse of single-use components.
General Guidelines for Reuse, Cleaning, and Disinfection
General guidelines for cleaning and disinfecting the suction unit and its parts.
Detailed Cleaning and Disinfection Procedures
Re-use of OB-J FA Suction Jar
Step-by-step guide for disassembling the OB-J FA jar for cleaning.
Cleaning and Disinfection of OB-J FA Jar and Silicone Tube
Detailed instructions for cleaning and disinfecting the OB-J FA jar and tube.
Disinfection Warnings and Filter Replacement
Disinfection Cycle Warnings
Important precautions to follow during the disinfection process.
Replacing the Antibacterial Filter
Procedure for correctly replacing the antibacterial filter.
Sterilization and Assembly of Jars
Sterilization of OB-J Jar and Silicone Tube
Guidelines for sterilizing reusable parts via autoclave.
Assembling the Jar with SERRES® Disposable Bag
Instructions for inserting a new disposable bag into the SERRES® jar.
Disposal and Cleaning of the Suction Unit
Disposal of Contaminated Single-Use Parts
Procedures for safely disposing of single-use contaminated components.
Cleaning and Disinfection of the Suction Unit Surface
How to clean and disinfect the external surfaces of the unit.
Cleaning and Disinfection Plan
A table summarizing cleaning and disinfection schedules for various parts.
Power Supply and Special Operating Conditions
Suction Unit Power Supply Requirements
Details on the required power source and fuse protection.
Operating Under Special Conditions
Information on operating the unit under extreme temperature/humidity.
Unit Demolition and Available Parts
Demolition and Recycling of the Suction Unit
Procedure for decommissioning and recycling the unit.
Accessories, Consumables, and Spare Parts List
Lists available parts, consumables, and accessories for the OB500.
Technical Data and Conformity Information
Detailed Technical Specifications
Detailed technical data including power, flow, noise, and dimensions.
EMC Electromagnetic Compatibility
Risks of Mutual Interference with Other Devices
Potential interference issues with other medical devices.
Methods to Prevent Electromagnetic Interference
Methods to mitigate interference from other equipment.
Electromagnetic Emissions Guidelines
Manufacturer's declarations regarding the unit's emissions.
Electromagnetic Immunity Guidelines
Electromagnetic Immunity Declarations
Manufacturer's declarations regarding the unit's immunity to interference.
Declaration of Conformity
Manufacturer's Declaration of Conformity
Formal statement of compliance with relevant directives and standards.
Product Warranty Information
Warranty Terms and Conditions
Details the product warranty period, coverage, and claim process.

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