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LINET ELEGANZA 1 User Manual

LINET ELEGANZA 1
70 pages
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ELEGANZA 1
Hospital bed for standard care
D9U001GT0-0101
Version: 09
Publication Date: 2020-02
Instructions for Use
and Technical Description

Table of Contents

Questions and Answers:

LINET ELEGANZA 1 Specifications

General IconGeneral
BrandLINET
ModelELEGANZA 1
CategoryMedical Equipment
LanguageEnglish

Summary

1 Symbols and Definitions

1.1 Warning Notices and Structure

Explains the types and structure of warning signals used in the manual for safety communication.

1.2 Instructions and Lists Formatting

Defines the standard format for instructions and bulleted lists to ensure clarity.

1.4 Package Symbols

Illustrates and defines symbols found on product packaging for handling and transport guidance.

1.5 Bed Symbols and Labels

Details various symbols and labels affixed to the bed for identification, safety, and compliance.

1.6 Serial Label and UDI

Explains the serial label format, including UDI information for traceability and identification.

1.7 Acoustic Signals (PB43 Control)

Lists and describes acoustic signals emitted by the PB43 control unit for operational feedback.

1.8 Acoustic Signals (PB11 Control)

Notes the absence of acoustic signals for the PB11 control unit, indicating a different feedback method.

1.9 Visual Signalisation Indicators

Describes visual indicators like LEDs on control panels for status, errors, and operational feedback.

1.10 Glossary of Terms

Provides definitions for key terminology used throughout the manual to ensure accurate understanding.

1.11 Abbreviations List

Lists and defines common abbreviations used in the document for technical terms and concepts.

2 Safety Instructions

General Safety Precautions

Comprehensive safety guidelines covering operation, handling, and maintenance to prevent injury and damage.

3 Intended Use and User Information

3.1 Intended User Population

Defines the intended users, including adult patients and caregivers for acute/long-term care.

3.2 Contraindications for Use

Lists conditions or patient types for which the bed is not suitable, requiring staff assessment.

3.3 Operator Roles Defined

Distinguishes between caregiver and patient roles in operating the bed's functions.

4 Incorrect Use Scenarios

Details specific situations and applications for which the Eleganza 1 bed is not suitable.

5 Product Description and Variants

5.1 Eleganza 1 (1GTP) - Single Collapsible Siderails

Overview of the Eleganza 1 bed model featuring single collapsible siderails and its components.

5.2 Eleganza 1 (1GTP) - Split Plastic Siderails (SR22)

Details the Eleganza 1 model equipped with split plastic siderails, SR22 type, and its features.

5.3 Eleganza 1 (1GTP) - Split Plastic Siderails (SR46)

Describes the Eleganza 1 model with split plastic siderails, SR46 type, and its specific components.

5.4 Eleganza 1 (1GTD) - Wooden Head/Foot Boards

Overview of the Eleganza 1 GTD model featuring wooden head and foot boards and their characteristics.

5.5 Eleganza 1 (1GTP) - Collapsible Siderails (Top Control)

Explains the Eleganza 1 model with single collapsible siderails controlled from the top.

5.6 Eleganza 1 (1GTP) - Collapsible Siderails (Bottom Control)

Details the Eleganza 1 model with single collapsible siderails controlled from the bottom.

6 Technical Specifications

6.1 Type B Applied Parts Classification

Identifies components accessible to the patient as Type B applied parts for safety compliance.

6.2 Mechanical Specifications (Standard Version)

Details mechanical dimensions, angles, and loads for the standard bed version.

6.3 Mechanical Specifications (Shortened Version)

Outlines mechanical specifications specific to the shortened version of the bed.

6.4 Safe Working Load (SWL)

Specifies the maximum safe load capacity of the bed based on castors and accumulator configuration.

6.5 Maximum Patient Weight Limits

Defines the maximum permissible patient weight considering application environment and accumulator status.

6.6-6.8 Environmental Conditions and EMC

6.6 Environmental Conditions

Specifies operating, storage, and transport conditions including temperature, humidity, and pressure limits.

6.7 Electrical Specifications

Details electrical parameters like voltage, power input, duty cycle, fuses, and sound pressure level.

6.8 Electromagnetic Compatibility (EMC)

Addresses EMC requirements, emissions, susceptibility, and user precautions for safe operation.

7 Use and Storage Conditions

General Use and Storage Guidelines

Outlines environmental restrictions for use and storage, and electrical installation requirements.

8 Scope of Delivery and Bed Variants

8.1 Scope of Delivery Verification

Instructions for checking product receipt and reporting discrepancies or damages immediately.

8.2 Bed Variants Overview

Lists and details the different available models and configurations of the Eleganza 1 bed.

9 Putting into Service

9.1 Accumulator Activation Procedures

Steps for activating the bed's accumulator, including foil removal and control section placement.

9.2 Head Board and Foot Board Installation

Instructions and safety warnings for installing the head and foot boards onto the bed frame.

9.3 Mattress Support Platform Details

Explains the mattress support platform, its sections, and includes information on the shortened bed variant.

9.4 Potential Equalisation Connector Usage

Explains the purpose and correct usage of the potential equalisation connector for patient safety.

9.5-11.2 Operation, Power, and System Checks

9.5 Pre-Use Operational Checks

Checklist of essential operational checks and preparations before using the bed.

9.6 Safe Bed Transport Guidelines

Instructions and precautions for safely moving and transporting the bed to prevent damage.

9.7 Firmware Update Information

Information regarding firmware updates, noting they require authorized service technicians.

10 Power Cable and Lockable Box

Details on connecting the power cable and using the lockable box for enhanced security and safety.

11 Accumulator Status and Management

Information on accumulator care, charging, troubleshooting faulty or discharged states, and status indicators.

11.3-11.4 Bed Removal and Accumulator Deactivation

11.3 Removing the Bed from Service

Procedure for safely decommissioning the bed and preparing it for storage or disposal.

11.4 Deactivating the Accumulator

Steps to deactivate the accumulator for storage or transport, ensuring device integrity and preventing damage.

12 Manipulation and Control Elements

12.1 MiniACP Supervisor Board Operation

Details the optional supervisor board, its components, and functions for bed control.

12.2 Attendant Control Panel (ACP) Guide

Comprehensive guide to the ACP, including STOP, GO, function buttons, and status indicators.

12.3 Handset Operation and Features

Instructions for using the standard handset, with and without illumination, for bed control.

12.4 Satellite Control Panel Usage

Information on the optional satellite control panel attached to the backrest for patient or caregiver use.

12.5 Siderail Integrated Control Element

Describes the optional control element integrated into the bed siderails for convenient adjustment.

12.6 Foot Control Functions and Settings

Explains the operation of the foot control for bed height adjustment and pre-programmed positions.

12.7 CPR Backrest Release Mechanism

Details the CPR lever for rapid mechanical lowering of the backrest during emergencies.

12.8 Siderail Types and Operation

12.8.1 Collapsible Siderails (3/4)

Instructions for operating 3/4 collapsible siderails, including locking and folding procedures.

12.8.2 Collapsible Siderails (Bottom Control)

Guide for single collapsible siderails controlled from the bottom, detailing folding and locking.

12.8.3 Split Plastic Siderails (SR22)

Operation and safety for split plastic siderails (SR22), including locking and stability checks.

12.8.4 Full Length Siderails Operation

Instructions for operating full length siderails, emphasizing secure locking for patient safety.

12.8.5 Split Plastic Siderails (SR46)

Operation and safety instructions for split plastic siderails (SR46), covering folding and locking.

12.9 Castor Control and Transport

12.9.1 Central Braking Control System

Explains the central braking system for castor control, facilitating bed movement and locking.

12.9.2 Individual Braking Control

Details the individual castor braking system for locking and unlocking each castor independently.

13 Equipment and 15 Accessories

13.1 Accessory Rails and Capacity

Describes the accessory rails on the bed, their load capacity, and compatible attachments.

13.2 Optional Green Light Indicator

Explains the function of the optional green light indicating the lowest mattress platform position.

15 Accessories Overview and Warnings

Lists all compatible accessories, emphasizing the use of original manufacturer parts for safety.

15.1 Lifting Pole and Infusion Stands

Details the installation, use, and safety guidelines for lifting poles and infusion stands.

15.3-15.5 Holders and 15.6 Protector

Covers name holders, urinary holders, and the Eleganza Protector for bed customization and safety.

15.7-15.8 Siderail Extenders

Explains the use of Extender® for raising siderail height, for top and bottom controlled siderails.

16 Cleaning and Disinfection Procedures

16.1 Safety Instructions for Cleaning

Critical safety measures to follow before, during, and after cleaning the bed to prevent injury.

16.2 General Cleaning and Disinfection Instructions

Guidelines for daily cleaning, pre-patient change cleaning, and complete disinfection processes.

16.3 Cleaning Modes Matrix

Table detailing cleaning and disinfection requirements for different bed components across various scenarios.

17 Troubleshooting Guide

Troubleshooting Common Bed Errors

Identifies common faults, their causes, and solutions for bed operation and adjustment issues.

18 Maintenance and Safety Checks

18.1 Regular Maintenance Schedule

Outlines routine checks for movable parts, accessories, and the accumulator for optimal performance.

18.2 Spare Parts Information

Provides information on how to obtain spare parts and identify the serial label for ordering.

18.3 Safety Technical Checks

Specifies the mandatory safety technical checks, their frequency, and required personnel.

19 Product Disposal and Environmental Considerations

19.1 Environmental Protection Policy

Details the company's commitment to environmental management and compliance with regulations.

19.2 Disposal Procedures

Outlines procedures for disposing of electric/electronic equipment and components in Europe and outside.

20 Warranty and Compliance

20 Warranty Terms and Conditions

Specifies the warranty period, coverage, exclusions, and requirements for service claims.

21 Standards and Regulations Adherence

Lists applicable standards and regulations the manufacturer adheres to, including quality management systems.

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