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Boscarol OB 1000 - User Manual

Boscarol OB 1000
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ED01_REV02-2021 IFU OB1000 - OB1000 AVIO_2P-ENG
BOSCAROL MEDICAL SUCTION UNIT
OPERATING INSTRUCTIONS
OB 1000 - OB1000 AVIO type FA
OB 1000 - OB1000 AVIO type FM
CORMOS type FA
CORMOS type LN
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Summary

Symbols and Pictograms

Symbols for Attention and Instructions

Explains symbols used in the manual to highlight important information and actions.

Device and Accessory Identification Symbols

Details symbols found on the suction unit and accessories for function and safety.

Battery and Compliance Symbols

Covers symbols related to the battery, WEEE, RoHS, CE mark, and other device compliance indicators.

Intended Use of Suction Units

Device Name and Primary Use

Identifies the device as a medical suction unit for fluid removal and its primary application.

Application and Patient Types

Specifies areas of application in the body and the types of patients it can be used on.

Usage Information and Time Limits

Outlines usage duration limits and information for medical professionals on performing suction procedures.

Safety Warnings and Precautions

General Safety Instructions

Emphasizes reading instructions, safe operation, avoiding flammable substances, and contacting service for issues.

Device Handling and Maintenance

Covers cleaning, avoiding liquid immersion, authorized maintenance, using original parts, and battery safety.

Environmental and Material Warnings

Addresses latex content, MRI environments, and RF interference precautions.

Operational and Environmental Safety

Equipment Proximity and Accessory Use

Warns against stacking equipment and using non-specified accessories due to potential interference.

Device Contamination and Disposal

Details procedures for contaminated units, prohibition of disassembly, and health authority notification.

Disposable Parts and Battery Charging

Advises against reusing disposable parts and outlines initial battery charging requirements.

Important Information and Safety

Pre-Use Information and Reporting

Covers pre-use checks, installation safety, and reporting of critical issues to the manufacturer.

Contraindications and Side Effects

Lists situations where the device must not be used and potential adverse effects during operation.

Medical Suction Units Overview

Package Contents

Lists the components included for FA and FM versions of the suction units.

Available Accessories and Options

Mentions optional accessories like mains power supply and support brackets.

Suction Unit Description

Details the unit's compliance, battery type, and the two basic versions (reusable/disposable jar).

Device Operation and Indicators

Controls, Operation, and Panel

Explains the function of the power switch, vacuum adjustment knob, and analogue vacuum gauge.

Indicator Lights and Battery Status

Details the meaning of Green, Yellow, and Orange LEDs for battery autonomy and charging status.

Periodic Testing Procedures

Daily Functionality Checks

Outlines the steps for a daily test to ensure device efficiency and absence of anomalies.

Test Result Interpretation

Provides a table correlating test results with recommended actions for negative outcomes.

Periodic Safety Inspections

Six-Monthly;Annual Testing Steps

Details comprehensive checks for device compliance, including pump operation, vacuum, battery life, and safety tests.

Device Compliance and Operation Standards

Emphasizes using manufacturer-approved parts and adhering to operational limits like inclination angle.

Safety and Maintenance Practices

Periodic Safety Maintenance Schedule

Recommends checks every 24 months, noting that inactivity can affect parts like the battery.

User, Patient, and Third-Party Safety Guidelines

Covers general safety, accessory checks, transport, battery, infection risks, and PPE.

Secretion Jars and Components

Autoclavable Jar (OB-J FA)

Describes the reusable jar, its parts, sterilization limits, and replacement conditions.

Antibacterial Filter Function

Explains the filter's role, disposable nature, replacement frequency, and handling precautions.

Secretion Jars and Accessories

SERRES Disposable Bag System

Details the components of the SERRES system, including the jar, adapter, connector, and disposable bag.

Yankauer Catheter and Single-Use Warnings

Describes the Yankauer catheter and warns against reusing disposable parts due to performance and infection risks.

Reuse, Cleaning, and Disinfection

Post-Use Procedures

Outlines disconnecting, disposing of parts, checking integrity, cleaning, and recharging after each use.

Infection Risk During Cleaning

Highlights the risk of infection from organic secretions and the need for PPE and disinfectants.

Cleaning and Disinfection of OB-J FA Jar and Tube

Cleaning Agent Recommendations

Advises using specific non-abrasive agents, avoiding colored disinfectants, and using warm water.

Disinfection and Sterilization Procedures

Outlines steps for cleaning, disinfection, and optional sterilization of reusable parts using steam autoclaves.

Jar Assembly and Tube Connection

Assembling the Jar Components

Describes placing components on a surface, checking for damage, and assembling the jar.

Antibacterial Filter Replacement

Filter Removal and Installation

Details how to disconnect the tube, remove/insert the filter, and dispose of it correctly.

Cleaning the SERRES Jar System

Disposable Bag Removal and Disposal

Guides on removing the Yankauer catheter, disconnecting tubing, and disposing of the used bag.

Disinfection and Sterilization of Reusable Parts

Sterilization Warnings

Lists warnings for sterilization cycles, including not sterilizing uncleaned parts and observing temperature/pressure limits.

Assembling the SERRES Jar

Inserting the Disposable Bag

Explains how to insert a new disposable bag into the jar and connect it to the unit.

Cleaning and Disinfection of the Suction Unit

Unit Surface Cleaning

Details cleaning the unit surface with a damp cloth and disinfectant, avoiding liquid immersion and solvents.

Cleaning and Disinfection Plan

Scheduled Cleaning Operations

Provides a table outlining cleaning, disinfection, and sterilization frequencies for various parts.

Accessories and Options

Support Bracket and Power Supply

Describes the support bracket and mains voltage power supply units, including their specifications and safety warnings.

Internal Battery Information

Battery Specifications and Lifespan

Details the hermetic lead-acid battery, its sealed nature, charging time, lifespan, and replacement recommendations.

Battery Disposal and Non-Use

Covers proper disposal of spent batteries and the importance of monthly recharging when not in use.

Special Conditions of Use

Temperature and Humidity Limits

Warns against extreme temperatures and humidity, and provides guidance for borderline conditions and condensation.

Device Demolition and Recycling

Recycling and Contaminated Waste Disposal

Explains WEEE recycling, handling of contaminated parts, and battery disposal requirements.

Parts and Consumables Catalog

Accessory Codes and Descriptions

Lists available accessories like support brackets and power supplies with their manufacturer codes.

Consumables and Spare Parts

Details consumables such as filters and bags, and spare parts like tubes and connectors.

Technical Service and Troubleshooting

Unauthorized Repairs and Warranty Voidance

States that only authorized personnel should perform repairs and that unauthorized actions void the warranty.

Common Malfunctions and Solutions

Lists common problems like unit not switching on or low vacuum, with their causes and solutions.

Troubleshooting Common Issues

Unit Not Working or Low Power

Addresses issues with the unit not working when connected, only working on external power, or having reduced autonomy.

Vacuum Power Adjustment Issues

Covers problems with adjusting vacuum power, increased noise, or vibration, and their potential causes.

Technical Data and Compliance

Device Classification and Standards

Lists device classification, UDI, suction level, operating mode, supply voltage, and relevant standards.

Environmental and Operational Specifications

Details operating temperature, storage, humidity, pressure ranges, and working altitude.

Technical Specifications and Usage

Dimensions, Weight, and Power

Provides device dimensions, weight, nominal suction power, vacuum regulation, and flow rates.

Battery and Pump Specifications

Lists battery type, charging details, max current load, and pump type.

Storage, Use, and Consumables Data

Storage and Operating Conditions

Specifies operating and storage temperature/humidity ranges, pressure, altitude, and rain protection.

Consumables Specifications

Lists specifications for antibacterial filters, disposable bags, and catheters.

Electromagnetic Compatibility (EMC)

EMC Guidelines and Precautions

Advises on installing and operating the device according to EMC information to avoid interference.

Electromagnetic Emissions Compliance

Details the unit's compliance with CISPR 11 for conducted and radiated emissions in a domestic environment.

Electromagnetic Immunity Guidelines

Immunity Test Compliance Levels

Lists compliance levels for immunity tests like electrostatic discharges and radiated radiofrequency.

Separation Distances for RF Equipment

Provides recommended separation distances from RF communication equipment to maintain device performance.

Declaration of Conformity

Manufacturer Declarations and Certifications

States manufacturer details, device classification, compliance with directives, and harmonized standards.

Notified Body and Approval Details

Includes information about the notified body, conformity assessment procedure, and approval dates.

Product Warranty

Warranty Period and Coverage

Specifies the 2-year warranty period, what is covered, and what is excluded.

Warranty Claim Procedures

Outlines the process for claiming warranty, required documentation, and conditions for responsibility.

Boscarol OB 1000 Specifications

General IconGeneral
BrandBoscarol
ModelOB 1000
CategoryMedical Equipment
LanguageEnglish

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