ELBUR: PB 521 II, PB 526 II
Elbur sp. z o.o. sp.k.
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1.0. Product description
1.1. Purpose and range of application
ELBUR adjustable nursing beds type PB are used to alleviate and
compensate for an injury, disability or disease. They ensure comfortable use
and contribute necessary care of infirm, frail people, thus enhancing
conditions of work for nursing staff. Electric regulation simplifies getting
in/out to bed, comfortable setting in chosen position and access to patient
during hygienic actions given by care assistant.
ELBUR nursing beds are developed and manufactured in accordance with
the current state of technical knowledge and all relevant safety standards.
Most importantly, they ensure basic safety and essential performance,
which are provided by the fulfilment of European laws and requirements:
•
Council Directive 93/42/EEC concerning medical devices;
•
EN 60601-1: Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance;
•
EN 60601-2-52: Medical electrical equipment - Part 2-52: Particular
requirements for basic safety and essential performance of medical
beds;
•
EN 60601-1-2: Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance - Collateral
standard: Electromagnetic compatibility - Requirements and tests;
•
EN 60601-1-6: Medical electrical equipment -- Part 1-6: General
requirements for basic safety and essential performance - Collateral
standard: Usability;
•
EN ISO 14971: Medical devices -- Application of risk management
to medical devices;
ELBUR nursing beds type PB are designed for application in nursing homes
and rehabilitation facilities (application environment 3
–
EN 60601-2-52),
also for care provided in a domestic area (application environment 4
–
EN 60601-2-52). They are intended to continuous use and care for infirm,
frail and handicapped people.
