PB 636 IV
Elbur sp. z o.o. sp.k.
6 of 36
1.0. Product description
1.1. Purpose and range of application
PB 636 IV adjustable nursing bed is used to alleviate and compensate
for an injury, disability or disease. It ensures 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.
PB 636 IV nursing bed si developed and manufactured in accordance
with the current state of technical knowledge and all relevant safety
standards. Most importantly, it ensures 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;
PB 636 IV nursing bed is 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). It is intended to continuous use and care for older, infirm,
frail and handicapped people. It should not being used by children younger
than 12 years old and mentally disabled people.
